U. S. SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-K

(Mark One)

☒	ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended DECEMBER 31, ~~2022~~2023

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

for the transition period from ___________ to _____________

Commission File Number: 000-54296

AXIM ~~Biotechnologies~~BIOTECHNOLOGIES, ~~Inc~~INC. (Exact name of registrant as specified in its charter)

Nevada		27-4029386
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification Number)
(State or other jurisdiction ofincorporation or organization)		(I.R.S. EmployerIdentification Number)

6191 Cornerstone Court, E, Suite 114

San Diego, CA 92121

(Address of principal executive offices)

Registrant’s telephone number, including area code: (858) 923-4422

Securities registered pursuant to Section 12(b) of the Act: None

Securities registered pursuant to Section 12(g) of the Act: Common stock, $0.0001 par value

Indicate by check mark whether the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate by check mark whether the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act of 1934 during the past 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether registrant has submitted electronically every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated Filer	☐	Smaller reporting company	☒
Emerging growth Company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

~~Yes ☐ No~~The ☒aggregate market value of the registrant’s voting equity held by non-affiliates of the registrant, as of June 30, 2023, the last day of the registrant’s most recently completed second fiscal quarter, was $5,340,925 (based on the closing sale price of the common stock reported on the OTC Markets, Inc. on June 30, 2023). For purposes of the above statement only, all directors, executive officers and 10% shareholders are assumed to be affiliates. This determination of affiliate status is not necessarily a conclusive determination for other purposes”. ☐

State the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant’s most recently completed second fiscal quarter. ☐

Note. - If a determination as to whether a particular person or entity is an affiliate cannot be made without involving unreasonable eff ort and expense, the aggregate market value of the common stock held by non-affiliates may be calculated on the basis of assumptions reasonable under the circumstances, provided that the assumptions are set forth in this Form.

APPLICABLE ONLY TO REGISTRANTS INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE PRECEDING FIVE YEARS:

Indicate by check mark whether the registrant has filed all documents and reports required to be fi led by Section 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☐ No ☐

(APPLICABLE ONLY TO CORPORATE REGISTRANTS)

Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date. ~~223~~278,~~649~~429,403

DOCUMENTS INCORPORATED BY REFERENCE

None

AXIM BIOTECHNOLOGIES, INC.

FORM 10-K

FOR THE YEAR ENDED DECEMBER 31, ~~2022~~2023

TABLE OF CONTENTS

		PAGE
PART I	~~PART I~~
Item 1.	BUSINESS	4
Item 1A.	RISK FACTORS	25
Item 1B.	UNRESOLVED STAFF COMMENTS	53
Item 2.	PROPERTIES	53
Item 1C	CYBERSECURITY	24
Item 3.	LEGAL PROCEEDINGS	53
Item 2.	PROPERTIES
Item 4.	MINE SAFETY DISCLOSURES	53
Item 3.	LEGAL PROCEEDINGS
	PART II
Item 4.	MINE SAFETY DISCLOSURES
Item 5.	MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES	54
PART II
Item 6.	[RESERVED]	55
Item 5.	MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES	26
Item 7.	MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	55
Item 6.	[RESERVED]	27
Item 7A.	QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	61
Item 7.	MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	27
Item 8.	FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA	61
Item 7A.	QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	33
Item 9.	CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE	61
Item 8.	FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA	33
Item 9A.	CONTROLS AND PROCEDURES	61
Item 9.	CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE	33
Item 9B.	OTHER INFORMATION	63
Item 9A.	CONTROLS AND PROCEDURES	33
Item 9C.	DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS	63
Item 9B.	OTHER INFORMATION	34
	PART III
Item 9C.	DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS	34
Item 10.	DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE	64
PART III
Item 11.	EXECUTIVE COMPENSATION	71
Item 10.	DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE	35
Item 12.	SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS	71
Item 11.	EXECUTIVE COMPENSATION	40
Item 13.	CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE	73
Item 12.	SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS	43
Item 14.	PRINCIPAL ACCOUNTANT FEES AND SERVICES	73
Item 13.	CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE	44
	PART IV
Item 14.	PRINCIPAL ACCOUNTANT FEES AND SERVICES	44
Item 15.	EXHIBIT AND FINANCIAL STATEMENT SCHEDULES	74
PART IV
	SIGNATURES	76
Item 15.	EXHIBIT AND FINANCIAL STATEMENT SCHEDULES	45
	SIGNATURES	47

2 ~~Table of Contents~~

WHERE YOU CAN FIND MORE INFORMATION

We file annual, quarterly and current reports, proxy statements and other information required by the Securities Exchange Act of 1934, as amended (the “Exchange Act”), with the Securities and Exchange Commission (the “SEC”). Our SEC filings are available to the public from the SEC’s internet site at http://www.sec.gov.

On our Internet website, http://www.aximbiotech.com, we post the following recent filings as soon as reasonably practicable after they are electronically filed with or furnished to the SEC: our annual reports on Form 10-K, our quarterly reports on Form 10-Q, our current reports on Form 8-K, and any amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act.

When we use the terms “AXIM,” “Company,” “we,” “our” and “us” we mean Axim Biotechnologies, Inc., a Nevada corporation, and its consolidated subsidiaries, taken as a whole, as well as any predecessor entities, unless the context otherwise indicates.

FORWARD LOOKING STATEMENTS

This Annual Report on Form 10-K, the other reports, statements, and information that the Company has previously filed with or furnished to, or that we may subsequently file with or furnish to, the SEC and public announcements that we have previously made or may subsequently make include, may include, or may incorporate by reference certain statements that may be deemed to be “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and that are intended to enjoy the protection of the safe harbor for forward-looking statements provided by that Act. To the extent that any statements made in this report contain information that is not historical, these statements are essentially forward-looking. Forward-looking statements can be identified by the use of words such as “anticipate,” “estimate,” “plan,” “project,” “continuing,” “ongoing,” “expect,” “believe,” “intend,” “may,” “will,” “should,” “could,” and other words of similar meaning. These statements are subject to risks and uncertainties that cannot be predicted or quantified and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, marketability of our products; legal and regulatory risks associated with trading publicly; our ability to raise additional capital to finance our activities; the future trading of our common stock; our ability to operate as a public company; our ability to protect our proprietary information; general economic and business conditions; the volatility of our operating results and financial condition; our ability to attract or retain qualified senior management personnel and research and development staff; and other risks detailed from time to time in our filings with the SEC, or otherwise.

Information regarding market and industry statistics contained in this report is included based on information available to us that we believe is accurate. It is generally based on industry and other publications that are not produced for purposes of securities offerings or economic analysis. Forecasts and other forward-looking information obtained from these sources are subject to the same qualifications and the additional uncertainties accompanying any estimates of future market size, revenue and market acceptance of products and services. We do not undertake any obligation to publicly update any forward-looking statements. As a result, investors should not place undue reliance on these forward-looking statements.

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PART I

Item 1. Business

Overview

Axim Biotechnologies, Inc., a Nevada corporation, is a leading developer of diagnostic healthcare solutions serving to enhance the health of people. Through the development of diagnostic solutions that quickly and accurately diagnose various diseases, our products allow healthcare workers to quickly test and treat at the point-of-care, which leads to improved patient outcomes and provides numerous economic benefits to the healthcare system.

Axim’s core competencies include development of rapid lateral flow immunoassays, reagents and monoclonal antibody development for such assays. Our current products fall into these categories:

(1) Eye Health, wherein we acquired two FDA cleared 510(k) tests for dye eye disease and have internally developed a third assay; and

(2) SARS-CoV-2 neutralizing antibody tests~~; and~~

Following the acquisition of two FDA cleared 510(3k) Atests ~~new~~for ~~fentanyl~~dye ~~neutralizing~~eye ~~antibody~~disease, ~~test~~the Company’s product focus has been primarily in ~~collaboration~~the area of Eye Health. We continue to maintain the products and assays developed in connection with ~~new~~SARS-CoV-2 ~~vaccines~~neutralizing ~~under~~antibody ~~development~~tests should a commercialization opportunity present itself in the future.

Following the acquisition of two FDA cleared 510(k) tests for dye eye disease, the Company’s product focus has been primarily in the area of Eye Health. We continue to maintain the products and assays developed in connection with SARS-CoV-2 neutralizing antibody tests should a commercialization opportunity present itself in the future. The Company is developing a new rapid diagnostic test to collaborate with leading universities to stop the deadly opioid crisis with new fentanyl vaccines.

Our principal executive office is located at 6191 Cornerstone Court, E. Suite 114, San Diego, CA 92121. Our telephone number is (858) 923-4422 and our website is www.aximbiotech.com. Unless expressly noted, none of the information on our website is part of this Report. Our common stock is quoted on the OTCQB Marketplace operated by the OTC Markets Group, Inc., under the ticker symbol “AXIM.”

Historical Business Operations

We were originally incorporated in the State of Nevada on November 18, 2010, under the name AXIM International, Inc. On July 24, 2014, we changed our name to AXIM Biotechnologies, Inc.

The Company’s historical business operations focused on the research, development and production of pharmaceutical, nutraceutical and cosmetic products based upon our proprietary technologies. This business and its related intellectual property were divested by the Company in May, 2020.

In March 2020, we acquired Sapphire Biotech, Inc. (“Sapphire”), a diagnostic healthcare solutions company, changing our business operations.

Acquisition of Sapphire Biotech, Inc.

On March 17, 2020, we entered into a Share Exchange Agreement with Sapphire and all of its stockholders, pursuant to which, upon closing of the transaction, we: (i) acquired 100% of Sapphire’s outstanding capital, consisting of 100,000,000 shares of common stock; and (ii) assumed all of the outstanding debt of Sapphire. The outstanding debt included two convertible notes in the principal amounts of $310,000 and $190,000, respectfully.

In exchange for 100% of the issued and outstanding shares of Sapphire, we issued an aggregate of 54,000,000 newly issued shares of ~~AXIM~~Company common stock to Sapphire’s existing stockholders (the “Share Exchange”). As a result of the Share Exchange, Sapphire became a wholly owned subsidiary of the Company, which has resulted in consolidated financial reporting by the Company to include the results of Sapphire.

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Acquisition of Advanced Tear Diagnostics, LLC Technology

On August 26, 2021, we purchased certain eye disease diagnostic technology from Advanced Tear Diagnostics, LLC, a Delaware Limited Liability Company (“Advanced Tear”), consisting of worldwide exclusive licenses to manufacture, distribute and sell 510(k) cleared medical diagnostic devices already being marketed for Lactoferrin, a biomarker for dry eye disease and a 510(K) license for IgE, a biomarker for allergic ocular reaction and ownership of the two FDA registered 510(k) clearances (collectively, the “DED Licenses”). Pursuant to the agreement, AXIM became the FDA registered owner of the two 510(k)’s. The purchase price for the technology licenses and the 510(k)’s was $4,270,000, which price was paid by issuing 7,000,000 restricted shares of Company common stock to Advanced Tear.

This asset purchase will prohibit another company from manufacturing the same devices under the 510(k)’s now owned by AXIM. Companies wishing to compete with AXIM by manufacturing the diagnostic devices acquire by AXIM must initiate a new 510(k) application and conduct costly clinical ~~trial~~trials in support of the lengthy clearance process.

Also on August 26, 2021, we purchased technology and intellectual property relating to electrochemical impedance spectroscopy which included five pending patent applications, (one of which has now been allowed by the ~~“Pending~~US ~~Patents”)~~Patent & Trademark Office, from Advanced Tear for $250,000 (~~includes~~included assuming and paying $30,000 of the Advanced Tear liabilities). The bulk of the purchase price ($210,000) was in a note that requires seven equal monthly payments of $30,000, which payment started on September 3, 2021. The note has since been ~~paid~~repaid in full.

Eye Health Overview

On August 26, 2021, we acquired the technology, intellectual property and the exclusive global rights to market two FDA cleared lateral flow assays which utilize a non-invasive, quantitative, point of care human tear test to aid in the diagnosis and selection of therapeutics for the treatment of eye diseases. With the acquisition, the Company became focused on improving the landscape for the diagnosis of ophthalmological conditions such as Dry Eye Disease (DED) through rapid diagnostic tests. The Company owns two of the only five FDA Cleared Diagnostic tests for Dye Eye Disease.

Currently, we have an FDA 510(k) clearance to test Lactoferrin (an aqueous deficiency biomarker) and IgE (a non-specific allergy biomarker). Our objective is to establish point of care testing for dry eye disease (“DED”) and to establish this modality as the new standard of care. The tests are quick, simple to use, and inexpensive to the clinic. The tests are CMS and private insurance reimbursable.

Low levels of Lactoferrin confirm inadequate glandular tear production (aqueous deficiency) and high levels of IgE indicate an active ocular allergy. If both biomarkers are normal, the cause of a patient’s dry eye condition could be attributed to evaporative dry eye. So, by performing these two tests, an eye doctor may now better assess the underlying cause of the tear film disorder, its severity and the appropriate treatment protocol to pursue. In addition, these tests are rapid, accurate, reimbursable, profitable and can be performed by a technician, which allows the physician to be more productive and attend to more patients.

While at one time the tests were sold in numerous eye doctors’ locations, when the Company acquired the assays, they had been mothballed. The Company has had to redevelop the tests, reagents and select a quantitative reader. Since the acquisition of the technology, the Company has been successful in redevelopment and is launching sales.

We have signed a supply agreement with Barcelona-based IUL SA (“IUL”) for our iPeak DED readers, which will be deployed for diagnostic testing with a focus on ~~lactoferrin~~Lactoferrin and IgE levels. This state-of-the-art portable reader is a colorimetric lateral flow reader designed to hold different cassette sizes and can read cassettes of up to five strips and seven lines per strip at a time.

iPeak is equipped with “Flash Eye” technology based on the principles of machine vision illumination. Its camera captures the image of the test illuminated from LED lights situated in the most studied geometry to achieve a precise and uniform illumination and enhance the colors of any lateral flow test. The iPeak technology also allows for more sensitivity, which is the main success of its application.

We evaluated the iPeak readers in the lab against several other comparable products before deciding on IUL’s state-of-the-art products. The Company’s diagnostic testing process for DED, and specifically for lactoferrin levels as a primary indicator, will include the use of reagent strip samples. The new readers are calibrated with the new test strips and will be distributed to ophthalmologists and optometrists at the point of care. The patients’ tear sample will be obtained and applied to the strips and then an ophthalmologist or optometrist will run the strips through a reader to determine lactoferrin levels and incidence and severity of DED.

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We evaluated the iPeak readers in the lab against several other comparable products before deciding on IUL’s state-of-the-art products. The Company’s diagnostic testing process for DED, and specifically for Lactoferrin levels as a primary indicator, will include the use of reagent strip samples. The new readers are calibrated with the new test strips and will be distributed to ophthalmologists and optometrists at the point of care. The patients’ tear sample will be obtained and applied to the strips and then an ophthalmologist or optometrist will run the strips through a reader to determine Lactoferrin levels and incidence and severity of DED.

On September 19, 2022 the Company announced that it had signed an exclusive global commercialization agreement with Verséa Ophthalmics, LLC, a business division of Verséa Holdings, Inc. (“Verséa”), is one of the fastest growing U.S. healthcare companies, specialized in the sale and distribution of diagnostic and therapeutic solutions.

Our tests are considered moderately complex by CLIA. This requires the user of the test to obtain a CLIA certificate of compliance. This is done by filing a simple application with CMS (Form 116) and paying a fee. However, there are various lab requirements that must be in place first, and there is a considerable amount of ongoing record keeping that is required, which restricts potential growth of the business. ~~Our distribution partner currently assists in the CLIA filing to provide as effortless process for the customer as possible.~~

The FDA allows for a CLIA ~~waiver~~waivers, and we intend to pursue a waiver for both current tests and all future product offerings. Our scientists have been diligently making patentable improvements to the tests which will simplify use by the clinician and enhance likelihood ~~the~~of CLIA waiver approval. We plan to file for the waiver ~~early~~ in the second quarter of ~~2023~~2024 after conducting a fairly simple comparative clinical study. The objective will be to determine whether the AXIM Eye test system has equal or better simplicity than the other forms of diagnostic testing for DED, which we believe is the case. This study is a key component of the filing process with the FDA for a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver. We believe that the acquisition of these FDA ~~510k~~510(k) cleared diagnostic products, a waiver and the distribution partnership we have with Versea will allow the business to grow at a rapid pace.

Dye Eye Market

An estimated 16 million Americans have been diagnosed with DED, but the actual number of Americans suffering from dry eye symptoms is likely much higher. Some reports indicate that nearly half of all U.S. adults experience dry eye signs and symptoms, and 33% of patients in eye care clinics present with complaints about dry eye.

DED, though widespread, is under-diagnosed, in part because symptoms do not always correlate with objective signs. It has a highly variable symptom profile at different stages of the disease, and there is often a discordance between signs and symptoms. A patient can have severe symptoms yet show no sign of ocular surface damage, while others have advanced ocular surface damage, yet report no symptoms. This lack of correlation between clinical signs and symptoms of DED makes diagnosing and treating patients a challenge. Often times, inflammation is present before the clinical signs of DED.

Currently, our eye business focuses exclusively on ophthalmology and optometry, in the United States, where there are 37,000 optometrists and 19,000 ophthalmologists performing approximately 400,000 medical (dilated) eye exams per day. Of this total, we believe that approximately 20% to 30% would present with symptoms where the Company’s Lactoferrin and IgE tests would be indicated. It is estimated that total US market for our eye care systems could approach 50,000 systems. (USA Only).

We have completed development of our immunoassay system, which includes an automated colorimetric photometer reader and two FDA market-cleared point-of-care (POC) quantitative diagnostic ophthalmic lab tests and are now manufacturing the tests. These are:

Ocular Lactoferrin )Lf) CPT code 83520 2021 CMS reimbursement $17.27/eye *

Ocular Immunoglobulin E (IgE) CPT Code 83520 2021 CMS reimbursement $16.46/eye*

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Studies indicate that in 2021, 16-49 million Americans had DED, representing 32 - 98 million potential use cases for our POC tests. These tests are not limited to DED diagnostics, but can also be used to determine the ~~lactoferrin~~Lactoferrin and allergic components of tear film prior to:

•● Contact lens fitting – approximately 45 million people wear contact lens in the US alone (2021). •● LASIK surgery- approximately 718,000 (2020). •● Cataract surgery with lens exchange - approximately 3.8 million (2018).

Business Model

Our eye business model utilizes a razor/razor blade model with the idea of placing as many readers into the field as possible and selling the disposable tests. It is anticipated that our gross profits will be generated from the manufacturing and sale of tests to our distribution partner who then resells the tests. Discounts will be offered to purchasing groups, corporate accounts, academic institutions engaged in research or training, and others as deemed appropriate. It is anticipated that the average price for the reader will be at our acquisition cost so we can get as many razors in the field, while pricing of consumable diagnostic kits will be at roughly half of the CMS published reimbursement floor rate.

Market demand for the system is expected to be moderate to begin with until we are granted a waiver from CLIA. At ~~that~~which time, we expect extremely high demand for our system and tests. We also expect very high demand for our recently developed MMP-9 quantitative test once we obtain a FDA 510(k) clearance. While we must compete with other capital equipment expenditures under consideration in any ophthalmic physician’s office, we believe that no other ophthalmic device offers the combination of compelling clinical and financial benefits afforded by our system. The clinical utility of the tests offers important diagnostic precision, differentiation and treatment management direction. Inner-office efficiencies significantly improve the patient flow characteristics, reducing patients in office visit time and greatly reducing physicians chair time with each patient.

Financially, for every patient tested per day, the physician will receive, on average, $2 in reimbursement for every $1 expended on supplies. CMS and private insurance allow for physicians to retest their patients as often as deemed medically necessary.

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Dye Eye Disease Market Competition

Currently there are five FDA approved tests for DED:

Biomarker	Company	Type	CLIA status
Lactoferrin	~~AXIM~~Axim	(quantitative analysis)	moderate complexity
IgE	~~AXIM~~Axim	(quantitative analysis)	moderate complexity
MMP9	Quidel	(qualitative only)	waived
Osmolarity	TearLab	(quantitative analysis)	waived
Ocular Adenovirus	Quidel	(qualitative only)	waived

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The preferred clinical analysis is quantitative, giving us an advantage over the competition. Since our reader can interpret many different analytes other than Lf and IgE, it also opens the possibility of additional quantitative test development.

New Quantitative MMP-9 Test

On March 8, 2022, we announced that we had successfully developed what we believe to be the first-ever rapid quantitative tear test for MMP-9, an inflammatory biomarker for DED. Matrix metalloproteinase-9 (MMP-9), an inflammatory biomarker consistently elevated in the tears of dry eye patients, may accelerate early diagnosis when detected.

Ocular surface disease (OSD) and dry eye syndrome are often mistakenly considered synonymous. OSD occurs when there is damage to the front surface of the eyes, the cornea. The central role of inflammation in OSD is widely recognized, but the ability to measure this in the clinic has been limited to the Quidel InflammaDry test, which measures tear matrix MMP-9 levels and provides a positive/negative result around a threshold of 40ng/ml of MMP-9. This “yes or no” report has clinical value, but it is limited. Currently available MMP-9 testing does not detect a reduction in tear MMP-9 levels until the concentration drops below 40ng/ml and, thus, may miss clinically significant improvement that did not reach that threshold.

The clinical benefits of our quantitative tear MMP-9 testing would be a significant advancement in the ability to measure the degree of inflammation affecting dry eye patients, allowing for more objective classification of their disease. Equally important would be the ability to measure improvement in control of inflammation that is the goal of many of our therapies for Ocular Surface Disease (OSD), including pharmaceuticals, thermal pulsation treatments and even light based therapies.

We intend to run a clinical study for MMP-9 in the ~~2nd~~3rd quarter of ~~2020~~2024. The distribution agreement we have with Versea calls for Versea to pay for half of the expense in return for a paid up license to market the test after the ~~FDA~~ 510(k) clearance is achieved.

We are also in the process of developing additional ~~bio-marker~~biomarker tests that will be ~~done~~used on the existing platform, without the constant need of the clinician to upgrade to a newer platform. The Lateral Flow test reader is software driven and can be programmed to interpret other biomarkers as they are clinically studied and FDA approved. The test uses 1.0 microliters of human tear fluid, that is applied to a disposable lateral flow cassette (one cassette per patient tested). The disposable single use cassette generates a substantial, ~~reoccurring~~recurring revenue stream for our eye business and our stakeholders.

8CURRENT ~~Table~~OPERATIONS ofFOLLOWING ~~Contents~~ACQUISITION OF SAPPHIRE AND ADVANCED TEAR DIAGNOSTICS ASSETS

CURRENT OPERATIONS FOLLOWING ACQUISITION OF SAPPHIRE AND ADVANCED TEAM DIAGNOSTICS ASSETS

Summary:

•● AXIM’s strategic focus is on commercializing FDA-cleared Dry Eye Disease (DED) diagnostic system •● Plans to address largely underserved DED diagnosis market with patent pending tear collection method and approved tests, supported by world-class DED management team •● Supply agreements in place to fulfill demand for DED readers and test strips, creating large revenue opportunity •● Company places emphasis on generating positive cash flow through DED program

The Company has been working diligently to further position AXIM for both immediate and long-term success. Since our acquisition of Sapphire Biotech and with the onset of the COVID-19 pandemic, we have been focused on three key areas specific to the diagnostic area;: oncological, COVID-19, and most recently, dry eye disease (DED). Each of these provide strong upside potential for AXIM; however, each comes with its own set of regulatory and scientific hurdles that must be overcome. While the Company ~~remain~~remains optimistic about each program, we believe it to be of the utmost importance to focus the most time and resources on the program with the ultimate potential for success, in the nearest term. While these other programs will not be abandoned, the Company recognizes that waiting on the painstaking slow regulatory approvals needed to generate revenue is not the best strategy to further our mission and unlock shareholder value. As such, following an extensive analysis by our management team, board of directors, and expert consultants with an objective perspective, the Company determined our best path forward lies with DED. The DED initiative is an extremely large opportunity for our Company and has been gaining strong momentum in recent months. The Company believes it offers the most potential for rapid and immediate growth, which could lead to ultimate profitability for the organization.

~~Since~~8 ~~the~~Table ~~third quarter~~ of 2021, we have acquired substantial assets, including already approved diagnostic tests, which complement the research we had been conducting to date. Despite DED being the most common ocular surface disorder, affecting approximately 350 million people worldwide—causing persistent eye irritation, blurred vision, pain and decreased quality of life—the sector has seen little innovation. There remains a desperate demand for better DED testing and diagnosis, especially at the point-of-care, and we believe we are well positioned to dominate this marketplace, while we actively work to develop and bring to market new solutions enabling us to offer comprehensive state-of-the-art suite of DED solutions.Contents

~~Our~~Since ~~next~~the third quarter of 2021, we have acquired substantial assets, including already approved diagnostic tests, which complement the research we had been conducting to-~~generation~~date. ~~solutions~~Despite ~~are~~DED ~~unique~~being inthe ~~that~~most ~~they~~common ~~offer~~ocular ~~patients~~surface ~~not~~disorder, ~~only~~affecting approximately 350 million people worldwide—causing persistent eye irritation, blurred vision, pain and decreased quality of life—the sector has seen little innovation. There remains a ~~fast~~desperate demand for better DED testing and ~~reliable~~diagnosis, ~~answer~~especially asat tothe ~~why~~point-of-care, ~~they~~and we believe we are ~~suffering~~well positioned to dominate this marketplace, ~~but~~while ~~also~~we ~~offer~~actively awork ~~solution~~to develop and bring to ~~physicians~~market ~~who~~new ~~are~~solutions ~~looking~~enabling us to ~~help~~offer ~~patients~~comprehensive ~~suffering~~state-of-the-art ~~from~~suite ~~this~~of ~~overly~~DED ~~common disease~~solutions.

Our next-generation solutions are unique in that they offer patients not only a fast and reliable answer as to why they are suffering, but offer a solution to physicians who are looking to help patients suffering from this overly common disease.

Covid Neutralizing Antibodies

Over the past few years, as COVID ravaged the world, our scientific team proved its world-class scientific acumen by swiftly developing first-in class COVID-19 neutralizing antibody tests. Shortly after its development, we filed for Emergency Use Authorization with the Food and Drug Administration (FDA), signed a distribution and manufacturing agreement, initiated live virus comparison studies, and filed several patent applications on the diagnostic tools. We waited in anticipation that the FDA would move quickly given the nature of the pandemic; however, we were disappointed week after week until we finally received a response that the FDA had changed its guidance and that they were denying our application. This was unfortunate especially given our firm belief in ~~its~~the efficacy of our test and the potential to assist in the global fight against this virus. In the last few months, we have adjusted our strategy to offer the rapid point-of-care test For Research Use Only to try and capture some revenue while we look for another partner to do the heavy lifting of running a new clinical study and resubmitting the EUA application. That said, we are fearful that the USU.S. government’s drive to approve such solutions is fading, and that it is unlikely to grant an EUA to ours or similar tests in the near future, although it is still a possibility since this virus is likely going to be around for a long time. ~~However,~~It it is this realism that further ~~underscored~~compelled ~~our need for a~~ readjustment of our focus on the DED program.

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DED Business

It is important to underscore the rationale supporting the Company’s decision to focus on DED. According to the American Academy of Ophthalmology, approximately 20 million people in the USU.S. ~~are~~have ~~afflicted with~~ DED and the number is growing in both young and old adults. It is imperative that clinicians determine how to best diagnose and treat DED.

Diagnosing DED is a particular challenge because of the multifactorial nature of the disease, with symptoms similar to other ocular surface conditions. There is often discordance between signs and symptoms, highlighting the need for more sensitive and accurate diagnostic tools. Figures from the American Journal of Ophthalmology corroborate this. As of July 2017, an estimated six million people reported DED symptoms without receiving a diagnosis.

The DED marketplace is massive, with analysts projecting the global market to grow at a CAGR of 6.6% from 2021 to 2026 and reach $6.1 billion by 2024.

Accordingly, in mid-2021, we started building the infrastructure and foundation needed to engage this large and dynamic market successfully. Our cutting-edge, next-generation solutions provide AXIM with far higher prospects of predictable growing revenue and earnings power.

On August 26, 2021, we signed an agreement to acquire two FDA-cleared 510(k)’s DED diagnostic testing technologies. The tests are part of a highly specialized point-of-care (POC) lab testing system explicitly designed to assist eye care physicians in detecting and quantifying various biomarkers associated with external ocular disorders. The tests are also approved for insurance and Medicare reimbursement. Both these tests are non-invasive, Rapid Lateral Flow Assays using tears:

~~The~~9 ~~first~~Table ~~is a rapid (10-minute) lateral flow diagnostic assay that tests for exact levels~~ of ~~lactoferrin through the collection of 1.0 microliter in tears. The benefits of testing lactoferrin Levels in the tear film include:~~Contents

•The ~~Low~~first ~~Lactoferrin~~is ~~levels~~a ~~directly~~rapid ~~correlate~~(10-minute) tolateral ~~DED~~flow ~~caused~~diagnostic byassay ~~aqueous~~that ~~deficiency~~tests •for ~~The~~exact ~~severity~~levels of ~~DED~~Lactoferrin ~~can~~through ~~be determined by~~ the ~~Lactoferrin~~collection ~~level~~of •1.0 ~~Low~~microliter ~~Lactoferrin~~in ~~levels~~tears. ~~may~~The ~~represent~~benefits ~~increased~~of ~~surgical~~testing ~~risk~~Lactoferrin orLevels ~~contact lens intolerance • Changes~~ in ~~Lactoferrin levels may show~~ the ~~efficacy~~tear offilm ~~the prescribed treatment~~include:

	●	Low Lactoferrin levels directly correlate to DED caused by aqueous deficiency
	●	The severity of DED can be determined by the Lactoferrin level
	●	Low Lactoferrin levels may represent increased surgical risk or contact lens intolerance
	●	Changes in Lactoferrin levels may show the efficacy of the prescribed treatment

The second test is for the measurement of Ocular Immunoglobulin E (IgE), a biomarker for allergies and a key biomarker primarily associated with Dry Eye Disease. The benefits of Testing IgE Levels in the Tear Film include:

•● The presence of IgE indicates the diagnosis of allergic conjunctivitis •● Levels of IgE increase with the severity of the allergic response •● IgE testing can help differentiate allergic conjunctivitis from dry eye syndrome •● Allergic conjunctivitis is a contraindication for LASIK and other surgical procedures

Lactoferrin is a tear protein that protects the ocular surface through antimicrobial and anti-inflammatory properties. Lower concentrations of lactoferrin have been demonstrated in patients with dry eye, which is associated with decreased aqueous tear production. Ocular Immunoglobulin E (IgE) is a biomarker for allergies and a key biomarker primarily associated with allergic conjunctivitis. Mild allergic conjunctivitis is frequently challenging to clinically distinguish from dry eye. AXIM’s diagnostic technology allows for eye doctors to not only identify and differentiate clinically overlapping conditions but also drive more targeted therapeutic interventions. The tests provide doctors with access to real-time quantitative results at the point-of-care, allowing them to better prescribe a therapy to patients, leading to overall improved personalized patient care.

10On ~~Table~~March 8th of ~~Contents~~last year, we announced that we had successfully developed what we believe to be the first-ever rapid quantitative tear test for MMP-9, an inflammatory biomarker for DED. Matrix metalloproteinase-9 (MMP-9) is an inflammatory biomarker consistently elevated in the tears of dry eye patients. The central role of inflammation in Ocular Surface Disease (OSD) is widely recognized, but the ability to measure this in the clinic has been limited to the Quidel InflammaDry test, which provides a positive/negative result. This “yes or no” report has clinical value, but it is limited. OSD occurs when there is damage to the front surface of the eyes, the cornea. OSD includes dry eye syndrome, but also refers to a number of other disorders that affect the surface of the eye and can cause significant issues with vision and quality of life.

OnThe ~~March~~clinical ~~8th~~benefits of ~~this~~our ~~year, we announced that we had successfully developed what we believe to be the first-ever rapid~~ quantitative tear ~~test for~~ MMP-9, antesting ~~inflammatory~~are ~~biomarker~~a ~~for~~significant ~~DED.~~advance ~~Matrix~~in ~~metalloproteinase-9~~the ~~(MMP-9)~~ability isto anmeasure ~~inflammatory biomarker consistently elevated in~~ the ~~tears~~degree of inflammation affecting dry eye patients., ~~The~~allowing ~~central~~for ~~role~~more ofobjective ~~inflammation~~classification inof ~~Ocular~~their ~~Surface~~disease. ~~Disease~~Equally ~~(OSD~~important ~~)is~~would ~~widely~~be ~~recognized, but~~ the ability to measure ~~this~~improvement in ~~the~~control ~~clinic~~of ~~has~~inflammation ~~been~~that ~~limited to the Quidel InflammaDry test, which provides a positive/negative result. This “yes or no” report has clinical value, but it~~ is ~~limited. OSD occurs when there is damage to~~ the ~~front~~goal ~~surface~~ of ~~the~~many ~~eyes,~~therapies ~~the~~for ~~cornea.~~ OSD, ~~includes~~including ~~dry eye syndrome~~pharmaceuticals, ~~but~~thermal ~~also~~pulsation ~~refers~~treatments ~~to a number of other disorders that affect the surface of the eye~~ and ~~can~~even ~~cause~~light ~~significant~~based ~~issues with vision and quality of life~~therapies.

The clinical benefits of our quantitative tear MMP-9 testing are a significant advance in the ability to measure the degree of inflammation affecting dry eye patients, allowing for more objective classification of their disease. Equally important would be the ability to measure improvement in control of inflammation that is the goal of many therapies for OSD, including pharmaceuticals, thermal pulsation treatments and even light-based therapies.

Key Diagnostic Device Supply Agreement

In February of this year, we entered into a key supply agreement for DED test strip readers which will be deployed for diagnostic testing, focusing on lactoferrin levels. The readers, a point of care medical device, will be supplied by Barcelona, Spain-based IUL SA (“IUL”). We will be utilizing state-of-the-art portable iPeak readers that were tested against other comparable products. These readers are designed to hold different cassette sizes and are equipped with connectivity and can read cassettes of up to five strips and seven lines per strip at a time. iPeak is equipped with “Flash Eye” technology based on the principles of machine vision illumination.

We are also in the process of developing additional biomarker tests that will be done on the existing platform, without the constant need of the clinician to upgrade to a newer platform. The Lateral Flow test reader is software-driven and can be programmed to interpret other biomarkers as they are clinically studied and FDA approved. The test uses 1.0 microliters of human tear fluid that is applied to a disposable lateral flow cassette (one cassette per patient tested). The disposable single use cassette generates a substantial, recurring revenue stream for our eye business.

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Exclusive Global Commercial Partnership

On September 19, 2022, the Company announced that it had signed an exclusive global commercialization agreement with Verséa Ophthalmics, LLC, a business division of Verséa Holdings, Inc. (“Verséa”), one of the fastest growing USU.S. healthcare companies, specialized in the sale and distribution of ocular diagnostic and therapeutic solutions.

The agreement will provide Verséa with the exclusive commercial right to AXIM’s proprietary portfolio of point-of-care (POC) lab testing readers and three key biomarker diagnostic tests designed specifically to assist eye-care physicians in detecting and quantifying biomarkers associated with aqueous deficient Dry Eye Disease and non-specific allergic conjunctivitis. ~~The three~~ AXIM’s three key biomarker tests – the Ocular Immunoglobulin E (IgE) test, the Lactoferrin test, and the future MMP-9 test – require the collection of 1.0 microliters in tears and provide quantitative results in under 10 minutes, an industry-leading return time.

On September 30, 2022, Verséa launched the IgE and Lactoferrin tests at the 2022 American Academy of Ophthalmology (AAO) and American Academy of Optometry (AAOPT) conferences. The MMP-9 test is anticipated to follow in ~~the~~2nd ~~next~~quarter ~~12-18~~2024 ~~months~~ upon FDA clearance. In recent months, AXIM has been preparing for the scaling of production of its tests in anticipation of significant new orders and is now prepared to support new orders associated with the ~~Verséa~~Versea agreement and subsequent launch.

The commercial launch of the Company’s IgE and Lactoferrin tests mark the evolution of ~~Axim~~AXIM as a development-stage biotech company to a revenue generating healthcare organization. Since the development of our novel ocular diagnostic tests and subsequent success in proving their effectiveness, the Company had been searching for a partner with a solid commercial infrastructure and a firm commitment to eye care, capable of bringing our tests to clinical offices on a global scale. With existing sales channels to support their human amniotic membrane therapeutics, Verséa has added our technology to their expanding portfolio of healthcare solutions. Our partner’s mission aligns with that of the Company’s—together, we aim to change the landscape of dry eye disease diagnosis.

11On ~~Table~~October 4, 2022, the Company announced that it had received an initial order of ~~Contents~~19,000 point-of-care (POC) diagnostic tests and 100 readers targeting ocular surface diseases through its exclusive global commercialization partner Verséa Ophthalmics, marking the Company’s first large-scale revenue generating order. To date we have delivered approximately 4000 tests.

OnThe ~~October~~order 4,is part of the ~~Company~~recently announced ~~that~~exclusive itglobal ~~had~~commercialization ~~received~~agreement anreached ~~initial~~between ~~order~~Verséa and AXIM to support the commercial launch of ~~19,000~~sales ~~point-~~at the 2022 American Academy of~~-care~~ Ophthalmology (~~POC~~AAO) ~~diagnostic~~conference ~~tests~~in Chicago. The order represents the largest revenue-generating event in the history of the Company. AXIM is completing the manufacturing and ~~100~~is ~~readers~~preparing ~~targeting~~the ~~ocular~~order ~~surface~~for ~~diseases~~shipment ~~through~~from its ~~exclusive~~laboratory ~~global~~facilities ~~commercialization~~in ~~partner~~San Diego, California as per Verséa’s ~~Ophthalmics,~~direction. ~~LLC~~The order includes both the tear based tests for Lactoferrin and Immunoglobulin E (~~“Verséa”~~IgE), ~~marking~~as well as 100 of the ~~Company’s~~associated ~~first~~digital ~~large~~reader that allows for quantitative test results. The tests provide doctors with access to real-~~scale~~time ~~revenue~~quantitative ~~generating~~results within 10 minutes, allowing them to more accurately diagnose and prescribe targeted therapy to patients, leading to overall improved personalized patient care. Both tests are FDA-cleared and have dedicated Medicare CPT codes that allow for rapid POC diagnosis of common ocular conditions such as dry eye disease (DED) and allergic conjunctivitis. On February 20, 2024 we announced that Verséa Ophthalmics placed an order for an additional 50 digital readers.

The order is part of the recently announced exclusive global commercialization agreement reached between Verséa and AXIM to support the commercial launch of sales at the 2022 American Academy of Ophthalmology (AAO) conference in Chicago. This order represents the largest revenue-generating event in the history of AXIM. AXIM is completing the manufacturing and is preparing the order for shipment from its lab facilities in San Diego, California as per Verséa’s direction. The order includes both the tear-based tests for Lactoferrin and Immunoglobulin E (IgE) as well as the 100 associated digital readers that allow for quantitative test results. The tests provide doctors with access to real-time quantitative results within 10 minutes, allowing them to more accurately diagnose and prescribe targeted therapy to patients, leading to overall improved personalized patient care. Both tests are FDA-cleared and have dedicated Medicare CPT codes that allow for rapid POC diagnosis of common ocular conditions such as dry eye disease (DED) and allergic conjunctivitis.

This large order through our agreement with Verséa Ophthalmics marks a pivotal point for AXIM, where we are revenue generating. This initial order through Versea also supports the Company’s vision that our tests and readers will become available in clinics nationwide. While our readers can be used over and over again, our test strips are one-time use, and we expect to receive repeat orders from clinicians who have performed the tests. This will be a significant revenue additive to the growing new test demand.

The expectation with the ~~Verséa~~Versea partnership is that the launch of the ocular surface disease testing platform is the beginning of a robust testing pipeline of future diagnostic test solutions that can be introduced on the same digital reader system. Eye care professionals have struggled with differentiating mild allergic conjunctivitis from dry eye disease as well as distinguishing between different causes of dry eye [aqueous deficient versus evaporative] which impacts clinical decision making. The portfolio of rapid, tear-based, quantitative point of care tests allows for more specific diagnoses, targeted therapeutic intervention and the potential for therapeutic monitoring which is a true breakthrough for the industry.

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CLIA Waiver Process

Commencing ~~early~~in ~~2023~~the 2nd quarter of 2024, the Company plans to conduct a comparative clinical study. The objective will be to prove that the AXIM Eye test system has equal or better simplicity than the other forms of diagnostic testing for DED. This study is a key component of our filing process with the FDA for a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver. We will be targeting a waiver for both IgE and the Lactoferrin diagnostic tests. The testing is expected to prove that the products are simple to use with minimal risks of erroneous results. The expected timeline for filing and receiving a final CLIA decision is approximately three to six months.

Patented Tear Collection System

Tear fluid analysis contributes to the greater understanding of various ocular and systemic diseases. However, there is a pressing need for a better tear collection system. AXIM ~~has~~is ~~invented~~developing and filed for a patent~~-pending~~ of a novel tear sample collector system that is extremely cost-effective to produce on a mass scale. It is soft, non-intimidating, and easy to use by untrained personnel. It features a simple indicator that appears on the strip when enough tear fluid has been absorbed. ~~We plan to develop this concept in 2023.~~

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AXIM 2023: Goals and Targeting Positive Cash Flow

Our DED business strategy is starting to take off. Looking ahead we plan to:

•● Successfully complete our clinical trials to prove the accuracy and ease of use to achieve CLIA waivers. •● Generate positive, peer- reviewed reviews by eye care professionals as to the performance and ease of use ~~• Evaluate other next-generation DED treatments that may include oral or topical therapeutics~~. We● have one in our cross-sights and, when ready, plan to commence clinical research with a leading university to prove safety and efficacy. If it works out as expected, we plan to pursue a license or business combination [IS THIS STILL ACCURATE?] • Penetrate the ophthalmologist and optometrist marketplace through our partner with our industry-changing DED diagnostic technology. •● Identify potential strategic acquisition targets to accelerate our DED diagnostic ~~and therapeutic~~ applications and capabilities expansion. •● Grow our DED business to reach a positive cash flow run rate by the end of 2023 and build its profitability beyond.

With our partnership with Versea, AXIM is now commercializing a healthcare solution that holds the potential to truly revolutionize the world. With the sales launch of AXIM’s diagnostic platform, AXIM is executing on our vision of penetrating a market where DED impacts over 350 million people worldwide. This strategy will enable our business to grow revenues and increase our earnings power to enhance shareholder value.

Milestones ~~2020~~ to Date

On January 13, 2020, Sapphire entered into an agreement with Skysong for an exclusive license to technology relating to SBI-183, an anti-metastatic compound suppressing tumor cell growth and blocking metastasis.

On February 6, 2020, Sapphire signed an SRA with Arizona State University to conduct in vitro testing and in vivo pre-clinical animal studies with cancer inhibitory agents that will prevent metastases.

On March 18, 2020, we announced the acquisition of Sapphire.

On March 24, 2020, Sapphire announced the completion of in-vitro studies on the new compound, SPX-1009, proving ten-fold greater inhibition of tumor metastasis than parent compound SBI-183 following testing of over 80 analogs.

On March 27, 2020, Sapphire signed an agreement with TD2 to initiate animal studies to evaluate the efficacy of SPX-1009 as an anti-metastatic treatment and to measure levels of QSOX1 as a potential companion diagnostic test.

On July 15, 2020, we announced the development of a rapid diagnostic test measuring levels of functional neutralizing antibodies that are believed to prevent SARS-CoV-2 from entering the host cells. Unlike currently available serological COVID-19 tests that detect an antibody response to the virus, our rapid 10-minute test measures a specific subpopulation of antibodies to block binding of the virus to host cell receptors. While there are expensive, time consuming laboratory tests that measure neutralizing antibodies, our test differs in that it is a portable, low cost, rapid point-of-care test with results in 10 minutes.

On August 5, 2020, we announced the development, patent filing and EAU filing of NeuCovix-HT™, a high throughput (“HT”) patent-pending diagnostic test that measures levels of functional antibodies in plasma or serum that neutralize SARS-CoV-2, the virus that causes COVID-19. Unlike current serology tests for COVID-19 that qualitatively detect antibodies to the virus, NeuCovix-HT™ quantitatively measures functional antibodies that block binding of the virus to host cell receptors. The patent filing and EUA filing have been withdrawn due to uncertain commercial potential for a HT test.

On August 11, 2020, Sapphire was awarded a $395,880 phase I SBIR grant by the National Cancer Institute (NCI). The grant has supported the continued development of novel small molecules that inhibit the enzymatic activity of QSOX1 based on a lead compound. QSOX1 is a tumor-derived enzyme that is important for cancer growth, invasion and metastasis. The company has filed a final grant report with NCI, detailing numerous research findings.

On August 24, 2020, we signed an exclusive limited licensing, manufacturing and distribution agreement with Empowered Diagnostics LLC (“Empowered Diagnostics”) for high volume production of our rapid diagnostic test measuring levels of functional neutralizing antibodies that are believed to prevent SARS-CoV-2 from entering the host cells. The agreement has since been terminated.

13 Table of Contents

On September 16, 2020, we filed the EUA application with the FDA for measuring COVID-19 neutralizing antibodies in plasma and serum through its first-in-class rapid diagnostic test. On January 2022, the FDA notified us that the priorities for testing had changed in favor of quantitative measurement of neutralizing antibodies, thus signaling that the Company’s EUA for the qualitative test would no longer be considered.

On September 22, 2020, we announced that the United States Patent and Trademark Office (“USPTO”) had issued the Company a new Notice of Allowance for a patent (Application No. 15/748,784) on anti-neoplastic compounds and methods targeting QSOX1, an enzyme important for tumor cell growth, invasion and metastasis.

On September 29, 2020, we announced that we had filed a provisional patent for a first-in-class face mask that captures and deactivates SARS-CoV-2, the coronavirus responsible for the ongoing COVID-19 pandemic.

On December 31, 2020, we announced that we had filed a provisional patent for a recombinant VBP for SARS-CoV-2, the coronavirus responsible for the current COVID-19 pandemic, and are now manufacturing the VBP. As a result, we no longer need to rely on outside protein supply to continue our research, greatly reducing our manufacturing costs.

On December 3, 2020, we announced the development and patent filing for an enzyme-linked immunosorbent assay (“ELISA”)-based diagnostic test for the detection of SARS‐CoV-2 neutralizing antibodies.

On February 3, 2021, we announced the initiation of clinical trials for ImmunoPass, our rapid point-of-care test that semi-quantitatively measures levels of neutralizing antibodies to COVID-19.

On March 8, 2021, we announced that we had successfully completed point-of-care clinical trials on our ImmunoPass rapid test that semi-quantitatively measures levels of COVID-19 neutralizing antibodies to help understand COVID-19 immunity, validate vaccine effectiveness and estimate how long the vaccine will be effective in patients.

On March 24, 2021, the Company, through Empowered Diagnostics, filed an EAU application with the FDA for measuring COVID-19 neutralizing antibodies in whole blood for a Point-of-Care rapid diagnostic test. This relationship has been terminated.

On August 03, 2021, we announced that the Company has signed a Binding Term Sheet to acquire the technology for the testing of Dry Eye Disease (DED), including two FDA clearances for the commercial sale of two ophthalmic diagnostic lab tests. The transaction closed on August 26, 2021.

On March 6, 2022, we announced that while the Company explores filing one or more EUA’s for point of care and/or at home use, it would begin to sell the Company’s neutralizing antibody (“Nab”) rapid test For Research Use Only (“RUO”) as it does not require FDA approval.

On March 8, 2022, we announced that we had successfully developed what we believe to be the first-ever rapid quantitative tear test for MMP-9, an inflammatory biomarker for Dry Eye Disease. Matrix metalloproteinase-9 (MMP-9), an inflammatory biomarker consistently elevated in the tears of dry eye patients, may accelerate early diagnosis when detected.

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On April 27, 2022, we announced the successful development of a rapid quantitative tear test for Lacritin, a tear protein that autonomously promotes tearing and is deficient in all forms of Dry Eye Disease.

On May 10, 2022, we announced the development of a novel tear sample collector system and the filing of a provisional patent application for it with the U.S. Patent and Trademark Office that provides a more comfortable experience for patients and that facilitates the tear collection process.

On May 24, 2022, we announced that we had completed the optimization of a rapid diagnostics test for the quantitative measurement of Ocular Immunoglobulin E (IgE), a biomarker for ocular allergies.

14 Table of Contents

On June 2, 2022, we launched the Company’s new mobile-optimized website designed to provide doctors, researchers and other medical professionals with tailored, timely information and resources that will enable them to make informed decisions when purchasing AXIM’s proprietary diagnostic tests.

On July 12, 2022, we announced our publication in collaboration with researchers at Arizona State University (ASU) entitled, “Third COVID-19 Vaccine Dose Boosts Neutralizing Antibodies in Poor Responders” in Communications Medicine, part of the Nature family of journals.

On July 21, 2022, we announced that Axim’s CEO John Huemoeller had been featured on the Vision is More Than 20/20™ podcast.

On July 26, 2022, we announced that we had developed an enhanced version of ~~its~~our rapid Ocular Immunoglobulin E (IgE) test in response to a study recently published in Nature that climate change is making allergy season occur sooner and for a longer period of time than in recent years.

On September 19, 2022, we signed an exclusive global commercial partnership agreement with Verséa Ophthalmics, LLC, a business division of Verséa Holdings, Inc. (“Verséa”), one of the fastest growing US healthcare companies, specialized in the sale and distribution of ocular diagnostic relating to Axim’s proprietary portfolio of point-of-care (POC) lab testing readers and three key biomarker diagnostic tests designed specifically to assist eye-care physicians in detecting and quantifying biomarkers associated with aqueous deficient Dry Eye Disease and non-specific allergic conjunctivitis.

On September 29, 2022, we started selling our ophthalmic point-of-care (POC) diagnostic product portfolio in advance of the American Academy of Ophthalmology Annual Meeting through our exclusive commercialization partner Verséa Ophthalmics, LLC, a subsidiary of Verséa Holdings, Inc.

On October 4, 2022, we received an initial order of 19,000 point-of-care (POC) diagnostic tests and 100 readers targeting ocular surface diseases through our exclusive global commercialization partner Verséa Ophthalmics, LLC (“Verséa”), marking the Company’s first large-scale revenue generating order.

On December 6, 2022, our commercial partner, Versea Ophthalmics highlighted the benefits of AXIM’s Eye Diagnostic Solutions in leading scientific media, including Eyes On 2023 and the Ophthalmology Times.

In both interviews, Dr. Rob Sambursky emphasized the improved features of AXIM’s tests, noting that while osmolarity testing is currently taking place with ocular surface disease patients, the rapid new tear based tests isare complementary to those existing tests and enhance a clinician’s ability to manage treatment in a more personalized way.

On December 13, 2022, AXIM announced the development of a novel dual IgE/MMP rapid ophthalmological diagnostic test for which the Company filed a provisional patent with the US Patent and Trademark Office. The new product offers clinicians an innovative new rapid ophthalmological diagnostic solution designed to reliably measure both Ocular Immunoglobulin E (IgE) and MMP-9 in a single test. The test is slated for further clinical development in the ~~first~~third quarter of ~~2023~~2024 and, once FDA approved, will be added to AXIM’s expanding catalog of ophthalmological diagnostic tools available to clinicians throughout North America.

~~INTELLECTUAL~~13 ~~PROPERTY~~Table of Contents

~~OVERVIEW:~~On April 11, 2023, we announced the start of manufacturing of both the Company’s proprietary Ocular Immunoglobulin E (IgE) and Lactoferrin diagnostic assays to fulfill the orders placed by its commercialization partner Versea.

Category	IssuedPatent	Provisional PatentApplications
QSOX-1	1	11
SARS-CoV-2		13
EYE Health		2
EIS Platform		6

On May 23, 2023, we announced the appointment of Kurt Phinney as the Company’s new Chief Operating Officer. Phinney is a seasoned healthcare operations executive and will play a vital role in scaling and optimizing AXIM’s manufacturing operations for its proprietary ophthalmological diagnostic assays in order to meet rising demand.

15On ~~Table~~July of12, ~~Contents~~2023, AXIM announced that it had begun shipping revenue generating validation kits for Ocular Immunoglobulin E (IgE), a key biomarker primarily associated with non-specific, allergic conjunctivitis, which often mimics Dry Eye Disease.

IOn July 25, 2023, Verséa™ Ophthalmics, LLC, a division of Verséa Health, Inc. ~~QSOX1~~announced the commencement of initial shipments of its T-~~RELATED~~POC ~~INVENTIONS~~TOTAL IgE Immunoassay and Lateral Flow Readers. The company focuses on delivering innovative Tear-based Point-of-Care (T-POC) testing and biologic solutions that optimize diagnosis, treatment, and management of various eye care conditions, including ocular surface disease and pterygium surgery.

~~QSOX1~~AXIM ~~(Quiescin~~supplies ~~Sulfhydryl~~the ~~Oxidase~~readers 1)and ismanufactures ~~an enzyme that is over-expressed in multiple tumor types. Genetically silencing QSOX1 in tumors slows their growth, migration, invasion~~ and ~~metastasis.~~supplies ~~Based on these findings,~~ the ~~inventors~~IgE ofImmunoassay ~~the inventions described below tested libraries of chemical compounds for the ability~~ to ~~inhibit QSOX1. Several inhibitors of the QSOX1 enzyme were identified. Initially~~Verséa, ~~SBI-183 was identified and animal studies confirmed~~ its ~~ability~~distribution ~~to suppress tumor growth~~partner. The inventors subsequently developed an entire library of analogs of the parent compound, SBI-183, detailed in several inventions below to identify compounds with greater inhibitory activity. These compounds have the potential to be developed into therapeutic treatments for metastasis and to be used in conjunction with other neoplastic treatments, such as chemotherapy.

~~Included~~On inAugust ~~the~~1, ~~group~~2023, ofAXIM ~~QSOX1-related~~announced ~~inventions~~that ~~below is~~ the ~~identification~~U.S. ofPatent a& ~~specific~~Trademark ~~splice~~Office ~~variant~~sent ~~of QSOX1, identified as QSOX1-L, as a unique Biomarker for~~ the ~~detection~~Company notices of ~~certain tumors overexpressing QSOX1~~U.S. ~~This~~patent ~~biomarker~~allowances ~~formed the basis~~ for ~~the~~three ~~invention~~separate ~~relating~~patents, toincluding aits ~~Rapid~~rapid ~~Diagnostic~~point ~~Test~~of ~~for~~care ~~certain~~neutralizing ~~cancers~~antibody test.

A.On ~~Anti~~September 12, 2023 AXIM announced that it has successfully developed the world’s first rapid, point-~~Neoplastic~~of-care, ~~Compounds~~non-invasive ~~and~~diagnostic ~~Methods~~assay ~~Targeting~~for ~~QSOX1~~the detection of abnormal alpha-synuclein, a known biomarker for Parkinson’s Disease using tears.

1.On USDecember ~~Provisional~~20, ~~Patent~~2023, ~~Application~~AXIM ~~No.~~announced ~~62/218~~that the Company had signed an agreement with contract manufacturer Auer Precision for the production of its two FDA-cleared diagnostic assays designed for point-of-care diagnosis of Dry Eye Disease (DED).~~732~~ The ~~filed~~partnership onwill ~~September~~enable ~~15,~~scaling ~~2015~~of production quantities of the assays to meet demand for the tests in a cost-effective way.

~~PCT~~On ~~Provisional~~February ~~Patent~~20, ~~Application~~2024, ~~W02017048712A1~~AXIM announced that Verséa™ Ophthalmics, LLC, placed an order for an additional 50 of IUL Lateral Flow Readers.

USAnticipated ~~Nonprovisional Application No. 15/748,784 filed on January 30, 2018~~Expenses

~~Patent~~During USthe 10next twelve months we anticipate incurring costs related to: (i) filing Exchange Act reports,~~894~~ (ii) contractual obligations,~~034~~ B2(iii) ~~Issued~~clinical ~~January~~trials, 19(iv) continued research and development, ~~2021~~and (v) inventory for sales of dye eye products.

~~Title:~~AXIM ~~Anti-Neoplastic~~INTELLECTUAL ~~Compounds and Methods Targeting QSOX1~~PROPERTY

~~Assignee:~~AXIM ~~Mayo~~has ~~Clinic/Arizona~~been ~~State~~developing ~~University~~a proprietary diagnostic platform that can be adapted to test for a variety of analytes including, for example, SARS-Cov-2, Lactoferrin, IgE, Lacritin, MMP-9. This innovative platform allows clinicians to detect with greater speed and accuracy different conditions that, as an example, allow for point of care testing of viruses, diseases, and conditions such as Dry Eye Disease. The platform capability can also be applied to rapid testing for vaccine candidates, including COVID vaccines and a potential Fentanyl vaccine. AXIM’s proprietary platform can also be used to enable point-of-care detection for one or more cancers using a unique cancer biomarker, QSOX1-L.

~~Exclusive~~New ~~Licensee:~~Patent ~~Axim Biotechnologies, Inc.~~ Allowances

~~Compounds~~AXIM ~~and~~was ~~methods~~recently ~~involving~~notified ~~inhibition~~by of the ~~enzymatic~~United ~~activity~~States Patent & Trademark Office (USPTO) of ~~QSOX1~~three patent allowances. The ~~compounds~~first patent application relates to COVID and ~~methods~~other ~~can~~neutralizing beantibody ~~used~~(Nab) intesting and treatment. ofThe ~~neoplastic~~allowance ~~cells~~confirms tothat ~~suppress~~AXIM ~~tumor~~was ~~growth~~a ~~and~~pioneer ~~invasion~~ in developing a ~~variety~~rapid point of ~~cancers,~~care ~~including~~Nab ~~but~~test ~~not~~and ~~limited~~its tonovelty. ~~myeloma~~Additionally, ~~and~~the ~~cancers~~company ofwas notified by the ~~breast,~~USPTO ~~kidney~~of a second patent allowance for systems and ~~pancreas~~methods for rapid diagnostic for various cancers. ~~Claims~~The ~~include~~invention relates to the ~~compound~~discovery ~~SBI-183~~by asAXIM scientists of a ~~neoplastic~~unique ~~agent~~biomarker ~~found~~for tocancer, ~~inhibit~~QSOX1-L. ~~tumor~~A ~~growth,~~third ~~invasion~~patent ~~and~~allowance ~~suppress~~was ~~metastasis~~received for a point-of-care ~~tumors~~apparatus byand ~~inactivating~~methods ~~QSOX1~~for detecting cancer that uniquely uses electrochemical or impedance spectroscopy (EIS).

a.14 ~~Continuation~~Table USof ~~Patent Application 17/124/242 filed on December 16, 2020~~Contents

~~Title:~~These ~~Anti-Neoplastic~~allowances ~~Compounds~~have increased the depth of AXIM’S IP portfolio to include 10 patent applications, including the 3 above allowed patent applications, that cover AXIM’s innovative platforms and ~~Methods~~technologies. ~~Targeting~~The ~~QSOX1~~Company sees a significant value in its IP portfolio whereas it may look to either further develop the covered technologies or license the IP to larger healthcare organizations, both creating significant upside value for the organization. These allowances further validate both the novelty and underlaying science of AXIM’s diagnostic technologies.

~~Assignee:~~Innovations ~~Mayo~~in ~~Clinic/Arizona State University~~Diagnostics

~~Exclusive~~While ~~Licensee:~~we ~~Axim~~continue ~~Biotechnologies~~to manufacture and ship our FDA-cleared diagnostic assays to customers through our commercialization partner, ~~Inc~~we have simultaneously continued to expand our value proposition through innovations in the diagnostics field, that are now protected under the USPTO. We see our growing IP portfolio as a major opportunity for the organization, with an unrealized market value which probably exceeds the company’s current market capitalization. For instance, while the original SAR COVID-19 virus which plagued the world in recent years received extensive attention from the medical community, our now protected assay methodology can be applied to any future mutations or new SARS viruses or vaccines.

~~Compounds~~Following ~~and~~is ~~methods~~an ~~involving~~overview ~~inhibition~~ of ~~the~~AXIM’s ~~enzymatic~~patent activity of QSOX1. The compounds and methods can be used in treatment of neoplastic cells, for example, to suppress tumor growth and invasion in a variety of cancers, including but not limited to myeloma and cancers of the breast, kidney, and pancreas. portfolio:

SARS-Cov-2~~. US Provisional Patent Application No. 62/916,065 filed on October 16, 2019~~

~~Title:~~Neutralizing ~~Chemical~~Antibody ~~Compounds~~Testing ~~that~~and ~~Inhibit~~Treatment. ~~QSOX1~~1 ~~for~~Allowed ~~the~~Patent; ~~Treatment~~3 ofUtility ~~Cancer~~Patent Applications.

Assignees: Arizona State University/Axim Biotechnologies, Inc.

Derivatives of the parent compound SBI-183 have been identified as inhibiting the enzymatic activity of QSOX1. These compounds can be used in treatment of neoplastic cells by suppressing tumor growth and invasion in a variety of cancers that overexpress QSOX1, including but not limited to myeloma and cancers of the breast, kidney and pancreas.

3. US Provisional Patent Application No. 62/916,067 filed October 16, 2019

Title: Anti-Neoplastic Compounds and Methods Targeting QSOX1

Assignees: Arizona State University/Axim Biotechnologies, Inc.

Exclusive Licensee: Axim Biotechnologies, Inc.

16 Table of Contents

Compounds that are structurally distinguishable from the compound, SBI-183 are SPX-013 and SPX-014, and have been identified as inhibiting the enzymatic activity of QSOX1. The compounds and methods can be used in treatment of neoplastic cells by suppressing tumor growth and invasion in a variety of cancers, including but not limited to myeloma and cancers of the breast, kidney and pancreas.

4. US Provisional Patent Application No. 62/944/283 filed December 5, 2019

Title: Anti-Neoplastic Compounds and Methods Targeting QSOX1

Assignees: Arizona State University/Sapphire Biotech, Inc.

Exclusive Licensee: Axim Biotechnologies, Inc.

Compounds that are structurally distinguishable from the SBI-183 have been identified as inhibiting the enzymatic activity of QSOX1. One in particular, SPX-1009, also inhibits tumor cell growth, migration and invasion in vitro and metastasis in a mouse model of triple negative breast cancer. This invention concerns analogs of this lead compound SPX-1009. In in vitro testing, the lead compound SPX-1009 and its analogs have been found to be more potent and to have improved pharmacodynamics in mouse models of cancer.

5. US Provisional Patent Application No. 62959752 filed January 10, 2020

Title: Anti-Neoplastic Compounds and Methods Targeting QSOX1 and Inhibiting Cellular Responses to MET Receptor.

Assignee: Axim Biotechnologies, Inc.

Compounds and methods involving inhibition of the enzymatic activity of QSOX1 and methods of inhibiting cellular responses to the MET receptor signaling are disclosed which include administering any one or more compounds or pharmaceutical compositions. The compounds and methods can be used in treatment of neoplastic cells, for example, to suppress tumor growth and invasion in a variety of cancers, including but not limited to myeloma and cancers of the breast, kidney and pancreas. The uniqueness of the invention relates to the combined inhibition of QSOX1 and cellular responses to the MET receptor signaling.

B. Unique Biomarker QSOX1-L Identified and Rapid Diagnostic for Various Cancers

1. US Provisional Patent Application No. 62/829,556 filed April 4, 2019;

Utility Patent Application No. 16/841,521 filed April 6, 2020

International Patent Application No. PCT/US2020/026936 filed April 6, 2020

Title: Systems and Methods for Rapid Diagnostic for Various Cancers

Assignee: Axim Biotechnologies, Inc.

QSOX1-L, a splice variant of QSOX1, has been identified as a novel biomarker of bladder cancer and possibly other cancers in serum. Proprietary antibodies have been generated that selectively detect only this variant and not others. QSOX1-L has been used to develop a rapid and cost-effective diagnostic test for bladder and possibly other urologic cancers from urine.

C. Unique Compound SPX-184 Invented and methods for Neoplastic Cell Growth Inhibition of Tumors and Cancers

2. US Provisional Patent Application No. 63/280,553 filed November 17, 2021Title: Compositions, Compounds, and Methods for Neoplastic Cell Growth Inhibition of Tumors and Cancers Assignee: Axim Biotechnologies, Inc.

The present invention generally relates to compositions, compounds and methods for the treatment of various tumors or cancer and cell growth inhibition utilizing SPX-184.

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II. SARS-CoV-2-RELATED INVENTIONS

A. Rapid Diagnostic Test to Measure Levels of Neutralizing Antibodies to SARS-CoV2

1. US Provisional Application No. 63/023,646 filed May 12, 2020

Title: Convalescent Plasma Testing and Treatment

Assignee: Axim Biotechnologies, Inc. (Axim) and Arizona State University (ASU)

Exclusive Licensee: Axim Biotechnologies, Inc. (ASU’s Interest)

Exclusive Licensee: Empowered Diagnostics, Inc. (Axim’s Interest). License terminated March 4, 2022.

The invention refers to a Rapid Test to measure levels of Neutralizing Antibodies to SARS-CoV2. Unlike currently available serological COVID-19 tests that detect an antibody response to the virus, the rapid 10-minute test measures a specific subpopulation of antibodies that block binding of the virus to host cell receptors. In contrast to current tests using live viruses which are time-consuming, expensive and require trained personnel in a tightly controlled laboratory setting to measure neutralizing antibodies, the rapid test is a portable, low cost, rapid point- of-care test that measures levels of neutralizing antibodies in 10 minutes.

2.The USinvention ~~Provisional~~is ~~Application~~a ~~No.~~diagnostic ~~63/144,454~~test ~~Filed~~intended ~~February~~for 1semi-quantitative measurement of neutralizing antibodies in plasma, ~~2021;~~serum USor ~~Provisional~~whole ~~Application~~blood of persons who have had recent or prior infection with SARS-CoV2 or have received a COVID-19 vaccine.

~~No.~~DRY ~~63/152,774~~EYE ~~Filed February 23, 2021.~~DISEASE

~~Title:~~Tests ~~Rapid~~for ~~LFA~~Human ~~Diagnostic~~Monomeric ~~Test~~Lacritin. to1 ~~Measure~~Utility ~~Levels~~Patent ~~of Neutralizing Antibodies to SARS- CoV-2 from Whole Blood~~Application

~~Assignee:~~The ~~Axim~~invention ~~Biotechnologies~~relates to a Rapid Point of Care test for Human Monomeric Lacritin. Lacritin is a tear protein that, ~~Inc~~in its monomeric form, autonomously promotes tearing and ocular surface survival. Lower concentrations of Lacritin may diagnose several eye diseases, including Blepharitis, Sjögren’s syndrome, Dry Eye Disease and other inflammatory conditions.

~~Exclusive~~Tear ~~Licensee:~~Sample ~~Empowered~~Collectors ~~Diagnostics,~~Systems ~~Inc~~and Methods. ~~License~~1 ~~terminated~~Utility ~~March~~Patent ~~4, 2022.~~Application

~~The~~Tear ~~invention~~fluid ~~methods~~analysis contributes to the greater understanding of various ocular and ~~test~~systemic ~~kits~~diseases ~~can~~and beobtaining ~~used~~adequate ~~with~~samples ~~any~~for tear analysis requires effective collection methods. Most tear sample incollectors ~~which~~on the ~~presence~~market use capillary designs as tear sample collectors. These designs are intimidating to the patient when a sharp looking object is approaching the eye, ~~absence~~are ~~and/or~~rather ~~quantity~~difficult ofto ~~neutralizing~~use ~~antibodies~~by ~~(Nabs)~~untrained personnel and are expensive to ~~SARS~~manufacture. Quidel InflammaDry is using a wick type tear sample collector that does not have any fill-~~CoV-2~~up indicator and is ~~desired~~rather intricate to beproduce ~~determined,~~on ~~such~~mass asscale. ~~for~~Other ~~example,~~prototype ~~serum,~~sample ~~plasma,~~collectors ~~whole~~employ ~~blood,~~Q-tip ~~saliva~~designs, ~~mucous~~filter paper strips (Schirmer’s test) are imprecise, ~~and~~some ~~other~~are ~~biological~~difficult ~~fluids~~to produce en masse. InThe invention relates to a ~~particular~~laminated ~~embodiment,~~and ~~the~~looped ~~invention~~tear ~~methods~~sample collector that addresses these and~~/or~~ ~~kits~~that ~~are~~is: ~~used~~1) ~~with~~Cost-effective ~~whole~~to ~~blood~~produce on mass scale 2) Features a fill-up indicator (in case of laminated version) 3) Easy to use 4)Soft and non-intimidating to user and patient.

~~All~~15 ~~Provisionals~~Table ~~referenced in 1. and 2. above relating to the LFA Diagnostic Test were the subject~~ of ~~a conversion into an International Patent Application No. PCT/US2021/032106.~~Contents

3.CANCER ~~US Provisional Patent Application No. 63/252,908~~DIAGNOSTICS

~~Filing~~Systems ~~Date:~~and ~~October~~Methods 6,for ~~2021~~Rapid Diagnostic for Various Cancers. 1 Allowed Patent Application

~~Title:~~QSOX1 ~~Development~~(Quiescin Sulfhydryl Oxidase 1) is an enzyme that is over-expressed in multiple tumor types. Genetically silencing QSOX1 in tumors has been shown to slow their growth, migration, invasion and metastasis. QSOX1-L, a splice variant of ~~the~~QSOX1, ~~Engender~~has ~~SAR~~been identified as a novel biomarker of bladder cancer and possibly other cancers in serum. Proprietary antibodies have been generated that selectively detect only this variant and not others. QSOX1-~~Cov2~~L ~~Recombinant~~has ~~Protein~~been ~~Variants~~used to develop a rapid and cost-effective diagnostic test for bladder and possibly other urologic cancers from urine.

~~Assignee:~~DIAGNOSTIC ~~Axim~~METHODS ~~Biotechnologies,~~AND ~~Inc.~~TOOLS

~~The~~Molecules ~~invention differentiates between antibodies that bind to the virus but do not neutralize~~ and ~~those~~Related ~~that~~Assays, doTest ~~bind~~Kits and ~~neutralize the virus~~Methods. ~~COVID-19~~1 ~~vaccines~~Utility doPatent ~~not~~Application, ~~induce~~1 ~~high~~Provisional ~~levels~~Patent of neutralizing antibodies in all recipients AXIM’s second generation test provides users with a test that shows if they responded to their COVID-19 vaccine and a semi-quantitative analysis of their neutralizing antibody levels in a single testApplication.

4.The USinvention ~~Provisional~~relates ~~Patent~~to ~~Application~~the ~~No.~~use ~~63/275~~of various recombinant proteins,~~856~~ test kits, test kit components and methods for detecting and measuring "binding antibodies" (for example, non-neutralizing antibodies) as well as "functional antibodies" (for example, neutralizing) in a single test and at the same time. Such test kit and method can advantageously improve the diagnosis and therapy of various diseases.

~~Filing~~Use ~~Date:~~of ~~November~~Micromesh 4,Materials ~~2021~~in Diagnostic Devices. 1 Provisional Patent Application

~~Title:~~When ~~Tests~~small ~~For~~sample ~~Detection~~sizes (0.1-2 microliters) are used, such as tears, there is a need for the sample to be spread out over the application area for a proper flow. The invention allows dispersion of ~~Neutralizing~~a ~~And~~small ~~Non-Neutralizing~~sample ~~Antibodies~~volume ~~and~~over ~~Related~~a ~~Methods~~wide area controllable by the mesh size. This enables homogeneous sample dispersion over the entire sample application area.

~~The~~VACCINE ~~invention~~DIAGNOSTIC relates to the detection of the percent neutralizing to non-neutralizing antibodies in a single test. Totality of non-Nab provides information on the presence of general innate immune response Nab test determines serum neutralizing activity. Ratio Nab/Non-Nab provides percent of protective Abs.TEST

5.Fentanyl ~~Continuation-in-Part~~Diagnostic ~~17/590,353~~Test. ~~filed on February~~ 1, ~~2022 to US~~ Provisional ~~Application~~Patent ~~17/319,08 filed on May 12, 2021~~Application

~~Title:~~Researches ~~Assay~~have ~~for~~reported ~~Neutralizing~~that ~~Antibody~~broadly neutralizing ~~Testing~~antibodies may prevent lethality from the fentanyl class of synthetic opioids. The University of Houston is developing a vaccine targeting the dangerous synthetic opioid fentanyl that could block its ability to enter the brain. The invention relates to a test that can measure neutralizing antibodies against fentanyl, either therapeutic or generated by anti-fentanyl vaccine. The test can be used to monitor the vaccine’s response and ~~Treatment~~help decide when a booster is needed.

~~Assignee:~~EIS ~~Axim Biotechnologies, Inc.~~ TECHNOLOGY

~~The~~Point ~~invention~~of ~~diagnostic~~Care ~~test~~Apparatus isand ~~intended~~Methods for ~~semi-quantitative~~Detecting ~~measurement~~Cancer ofUsing ~~neutralizing~~Electrochemical ~~antibodies~~Impedance ~~in plasma, serum~~ or ~~whole~~Capacitance ~~blood~~Spectroscopy of(EIS). ~~persons~~1 ~~who~~Allowed ~~have~~Patent, ~~had~~1 ~~recent~~Utility orPatent ~~prior infection with SARS-CoV2 or have received a COVID-19 vaccine.~~Application

6These inventions relate to detection tools, diagnostics and related methods involving the use of an electrochemical sensor in conjunction with electrochemical impedance spectroscopy or electrochemical capacitance spectroscopy (EIS). ~~Continuation-~~Such detection tools may be utilized to detect cancer via biomarkers contained in~~-Part~~ ~~17/726~~bodily fluids. Many different analyte detection devices and systems exist. However, ~~431~~those ~~filed~~that oncan ~~April~~be 21practically applied in a clinical, ~~2022~~point of UScare ~~Provisional~~or ~~Application~~other ~~17/319,08~~setting ~~filed~~requiring onaccuracy ~~May~~and ~~12,~~reliability ~~2021~~are fairly limited and tend to be complex and expensive.

Title: Assay for Neutralizing Antibody Testing and Treatment

Assignee: Axim Biotechnologies, Inc.

18 Table of Contents

The invention diagnostic test is intended for semi-quantitative measurement of neutralizing antibodies in plasma, serum or whole blood of persons who have had recent or prior infection with SARS-CoV2 or have received a COVID-19 vaccine. A sequence listing was filed with the application relating to the implementation of new variants to SARS-CoV-2 into the invention diagnostic test to detect neutralizing antibodies.

B. AlphaLisa Assay for High Throughput Detection of Neutralizing Antibodies to SARS-CoV2

1. US Provisional Application No. 63/060,635 filed August 3, 2020; US Provisional Application No. 63/061,112 filed August 4, 2020

Title: NeuCovix-HT AlphaLisa assay for high throughput detection of Neutralizing Antibodies to SARS-CoV-2

Assignee: Axim Biotechnologies, Inc. and Arizona State University (ASU)

Exclusive Licensee: Axim Biotechnologies, Inc. (ASU’s Interest)

The invention refers to an AlphaLisa assay for high throughput (HT) detection of Neutralizing antibodies to SARS-CoV-2. Included in the claims is the HT diagnostic test that measures levels of functional antibodies in plasma or serum that neutralize SARS- CoV-2, the virus that causes COVID19. Unlike current serology tests for COVID 19 that qualitatively detect antibodies to the virus, the HT test quantitatively measures functional antibodies that block binding of the virus to host cell receptors.

All provisionals relating to the AlphaLisa Assay have been abandoned due to the Company’s decision that commercialization of this technology is not viable.

C. Direct Competitive ELISA for the Detection of SARS-Cov2 Neutralizing Antibodies

1. US Provisional Application No. 63/152,807 filed February 23, 2021

Title: Direct Competitive ELISA for the Detection of SARS-CoV2 Neutralizing Antibodies

Assignee: Axim Biotechnologies, Inc.

The invention relates to a method for rapid detection of SARS-CoV2 Neutralizing Antibodies in one of the following test samples: human or animal serum, plasma, saliva, tear, sweat, exhaled breath condensate. The test sample is mixed with an ACE2 label detection reagent. The sample mixture is incubated, and the quantity of ACE2 label detection reagent bound to the RBD molecules indicates the quantity of SARs-Co2 Neutralizing Antibodies.

The provisional relating to the ELISA technology has been abandoned due to the Company’s decision that commercialization of this technology is not viable.

D. ACE2 Variants

1. US Provisional Application No. 63/081,811 filed September 22, 2020

Title: Super-ACE2 Variants

Assignee: Axim Biotechnologies, Inc.

The invention relates to a new variant recombinant protein of ACE2 identified as ACE2-614-Fc (“Super ACE2”), that is more potent and has a longer shelf life and is more stable than wild type ACE2. Super ACE2 variant can be used in a variety of ways as follows:

a. Development of competitive assays for neutralizing antibodies that disrupt RBD- ACE2 interaction.

b. Direct assays for virus spike antigens. Super ACE2 acts as a very specific antibody to capture Spike proteins through the RBD domain.

c. Cardio-vascular, blood-pressure and related disorders therapeutic and diagnostic.

d. Anything related to the virus capture such as (i) Mask treatments, (ii) Aerosols, (iii) Sprays and drops, (iv) Ointment and dermal applications, (v) Surfaces

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E. Facemask Having Enhanced Infectious Agent Capturing and Related Methods

1. US Provisional Application No. 63/066,104 filed August 14, 2020;

US Provisional Application No. 63/084,407 filed September 28, 2020

Title: Facemask Having Enhanced Infectious Agent Capturing and Related Methods

Assignee: Axim Biotechnologies, Inc.

The invention is a facemask with a filtration material and an infectious agent capture-moiety. Infectious agent capture-moiety refers to any compound or biomolecule that can bind to any infectious agent. The filtration material acts as a scaffold to either directly block or impede the flow-through of the infectious agent or to support the infectious agent capture moiety. The infectious agent capture-moiety then functions to directly block or impede the flow-through of an infectious agent. The infectious agent-capture moiety can be aerosolized and sprayed or applied onto pre-treated filtration material and can be specific to capture infectious agents, such as SARS-CoV-2. In such embodiments, the facemask is capable of providing enhanced protection for the user and to others from SARS-CoV2.

F. Molecules and Related Assays, Test Kits and Methods

1. US Provisional Patent Application No. 63/378,673

Filing Date: October 6, 2022

Title: Molecules and Related Assays, Test Kits and Methods

Assignee: Axim Biotechnologies, Inc.

Various recombinant proteins, test kits, test kit components and methods for detecting and measuring first and second different antibodies are provided in the invention. In some aspects, a test kit and method for detecting and measuring “binding antibodies” (for example, non-neutralizing antibodies) as well as “functional antibodies” (for example, neutralizing) in a single test and at the same time are demonstrated. Such test kit and method can advantageously improve the diagnosis and therapy of various diseases.

III. TECHNOLOGY PLATFORM-RELATED INVENTIONS

A. Electrical Capacitance/Impedance Spectroscopy

1. Title: Imaginary Impedance Approach and Signal Decoupling Algorithm for Multi-Marker Detection Using Electrochemical Impedance Spectroscopy.

U.S. Patent Application

Serial No.: 16/495,682

Filed: March 20, 2018

Exclusive License of Advanced Tear Diagnostics, LLC’s (ATD)

Interest: Axim Biotechnologies

Co-owned by Arizona State University.

Methods for detecting one or more analytes in a sample utilizing Electrochemical Impedance Spectroscopy (EIS) measurement. In one method, analyte detection includes comparing an imaginary impedance measurement to a calibration curve of concentrations for each target analyte. The calibration curve of concentrations for each target analyte is established at an optimal frequency. In another method, a signal decoupling algorithm is utilized for detection of more than one analyte on an electrode.

2. Title: Electrochemical Osmolarity or Osmolality Sensor for Clinical Assessment.

U.S. Provisional Patent Application Serial No.: 62/455,913. Filed: February 7, 2017 PCT: W02018 148236

Exclusive Licensee of ATD’s Interest: Axim Biotechnologies, Inc.

Co-owned by Arizona State University

20 Table of Contents

Osmolality and osmolality sensors and methods utilizing electrochemical impedance to detect changes in impedance to varying salinity concentrations. By way of example, the impedance reported at the specified frequency varies logarithmically with the concentration of sodium chloride subject to the sensor surface. Measurements obtained by the sensors and methods herein are utilized, for example, to differentiate between the clinical stages of dry eye disease (290- 316 mOsm/L) to complement the current diagnostic procedures. Blood serum, urinalysis, and saliva also may be tested and the corresponding osmolarity or osmolality level evaluated for indications of a disease or condition.

3. Title: Point of Care Apparatus and Methods for Analyte Detection Using Electrochemical Impedance Spectroscopy.

U.S. Provisional Patent Application: US2021/011778171. PCT/US 2018 03760.

Filed: May 4, 2018

Exclusive Licensee of ATD’s

Interest: Axim Biotechnologies, Inc.

Co-owned by Arizona State University

The presence of analytes can be detected in the bodily fluid using Electrochemical Impedance Spectroscopy (“EIS”) or Electrochemical Capacitance Spectroscopy (“ECS”) in devices, such as handheld point-of-care devices. The devices, as well as systems and methods, utilize using EIS or EIS in combination with an antibody or other target-capturing molecule on a working electrode. Imaginary impedance or phase shift, as well as background subtraction, also may be utilized.

4. Title: Point of Care Apparatus and Methods for Detecting Cancer Using Electrochemical Impedance or Capacitance Spectroscopy.

U.S. Provisional Patent Application

Serial No.: 16/119,989

Filed: August 3, 2018

Exclusive Licensee: Axim Biotechnologies, Inc.

The presence of cancer biomarkers or other analytes can be detected in the bodily fluid using EIS or ECS in devices, such as handheld point-of-care devices. The devices, as well as systems and methods, utilize using EIS or ECS in combination with an antibody or other target-capturing molecule on a working electrode. Imaginary impedance or phase shift, as well as background subtraction, also may be utilized.

5. Title: Point of Care Apparatus and Methods for Detecting Cancer Using Electrochemical Impedance or Capacitance Spectroscopy.

U.S. Patent Application Continuation-in-Part.

Serial No.: 16/121,474 Filed: September 4, 2018

Exclusive Licensee: Axim Biotechnologies, Inc.

This disclosure is related to detection tools, diagnostics and related methods in volving the use of an electrochemical sensor in conjunction with electrochemical impedance spectroscopy or electrochemical capacitance spectroscopy, and more particularly to using such tools to detect cancer via biomarkers contained in bodily fluids using such detection tools, diagnostics, and related methods. Many different analyte detection devices and systems exist. However, those that can be practically applied in a clinical, point of care or other setting requiring accuracy and reliability are fairly limited and tend to be complex and expensive.

6. Title: Point-of-Care Apparatus and Methods for Detecting Cancer Using Electrochemical Impedance or Capacitance Spectroscopy

US Patent Application No. 17/876,364

Filing Date: July 28, 2022

Assignee: Axim Biotechnologies, Inc.

21 Table of Contents

IV. EYE HEALTH

1. Title: TEAR SAMPLE COLLECTORS, SYSTEMS AND METHODS

U.S. Provisional Patent Application No. 63/307,987 filed February 8, 2022.

Exclusive Assignee: Axim Biotechnologies, Inc.

Tear fluid analysis contributes to the greater understanding of various ocular and systemic diseases and obtaining adequate samples for tear analysis requires effective collection methods. Most tear sample collectors on the market use capillary designs as tear sample collectors. These designs are intimidating to the patient when a sharp looking object is approaching the eye, are rather difficult to use by untrained personnel and are expensive to manufacture. Quidel InflammaDry is using a wick type tear sample collector that does not have any fill-up indicator and is rather intricate to produce on mass scale. Other prototype sample collectors employ Q-tip designs, filter paper strips (Schirmer’s test) are imprecise, some are difficult to produce en masse. Here we introduce a laminated and looped tear sample collectors that addresses the above problems and that are: 1) Cost-effective to produce on mass scale 2) Features a fill-up indicator (in case of laminated version) 3) Easy to use 4)Soft and non-intimidating to user and patient.

2. Title: TESTS FOR HUMAN MONOMERIC LACRITIN

US Patent Application No. 63/301,437 Filed January 20, 2022

Exclusive Licensee: AXIM Biotechnologies, Inc.

The invention relates to a Rapid Point of Care test for Human Monomeric Lacritin. Lacritin is a tear protein that, in its monomeric form, autonomously promotes tearing and ocular surface survival. Lacritin is the only identified growth-like factor decreased in tears from patients with ocular surface inflammation resulting from blepharitis, and it is downregulated in contact lens-related dry eye. This provisional describes six different lateral flow assay designs for the detection of monomeric lacritin from human tears to diagnose blepharitis, Sjögren’s syndrome, Dry Eye Disease and other inflammatory conditions or as companion diagnostics at point of care settings.

V. TRADEMARKS

We have two trademarks registered with the United States Patent and Trademark Office: Axim (Registration Date: May 19, 2015; and Axim Biotech (Registration Date: May 31, 2016).

Table of Contents

Market, Customers and Distribution Methods

Our focus is on the development of innovative pharmaceutical and diagnostic products. We plan to be an active player in the field of biosciences with our extensive R&D and pipeline of innovative products. Currently, our eye business focuses exclusively on ophthalmology and optometry, in the United States, where there are 37,000 optometrists and 19,000 ophthalmologists performing approximately 400,000 medical (dilated) eye exams per day.

Competition

The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products.

We face competition from many different sources, including commercial pharmaceutical and biotechnology enterprises, academic institutions, government agencies, and private and public research institutions. Our commercial opportunities will be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer side effects or are less expensive than any products that we or our collaborators may develop based on the use of our technologies.

22 Table of Contents

While we believe that the potential advantages of our new technologies will enable us to compete effectively against other providers of technology for Covid-19 NAb product development and manufacturing, many of our competitors have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, clinical trials, regulatory approvals and marketing approved products than we do. Smaller or early stage companies may also prove to be significant competitors, particularly through arrangements with large and established companies, and this may reduce the value of our technologies. In addition, these third parties compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies and technology licenses complementary to our programs or advantageous to our business.

The barrier for entrance into the dry eye space is difficult and requires extensive clinical studies, large capital expense and FDA ~~510k~~510(k) clearance. This process alone can take several years and substantial investment, with no certainty that the product will receive FDA ~~510k~~510(k) clearance. It is estimated that as of 2021, the total Company funding necessary to develop a Class II ~~510k~~510(k) cleared medical device is approximately $30 million. The development and engineering costs comprise approximately $2-5 million of this total. There are many factors that influence these costs, including the need for clinical studies, regulatory pathway and technology complexity.

We believe that we are well situated in the Eye Health sector with two 510(k) cleared tests. Additionally, the preferred clinical analysis is quantitative, giving us an advantage over the competition. Since our reader can interpret many different analytes other than Lf and IgE, it also opens the possibility of additional quantitative test development.

Source and Availability of Raw Materials

In ~~General,~~general there are a limited number of suppliers for raw materials that we use to manufacture our products and product candidates, and there may be a need to assess alternate suppliers to prevent a possible disruption of the manufacture of the materials necessary to produce our product candidates for clinical trials, and if approved, ultimately for commercial sale. We do not have any control over the process or timing of the acquisition of these raw materials by us.

We currently manufacture the majority of our ~~preclinical and Covid-19~~ testing materials in-house, and use contract manufacturers for the manufacture of some of our product candidates. We may or may not manufacture the products we develop, if any. Our internal manufacturing and contract manufacturers are subject to extensive governmental regulation. In the dry eye segment, we either make our reagents or they are sourced from select suppliers. We use contract manufacturers for the manufacture of our assays and readers.

In17 ~~the~~Table ~~dye eye segment, we either make our reagents or they are sourced from select suppliers. We use contract manufacturers for the manufacture~~ of ~~our assays and readers.~~Contents

Government Regulation

Government authorities in the USU.S. (including federal, state and local authorities) and in other countries extensively regulate, among other things, the manufacturing, research and clinical development, marketing, labeling and packaging, storage, distribution, post-approval monitoring and reporting, advertising and promotion, export and import of pharmaceutical products, such as those we are developing. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources. Moreover, failure to comply with applicable regulatory requirements may result in, among other things, warning letters, clinical holds, civil or criminal penalties, recall or seizure of products, injunction, disbarment, partial or total suspension of production or withdrawal of the product from the market. Any agency or judicial enforcement action could have a material adverse effect on us.

23Many, ~~Table~~if not all of ~~Contents~~our customers, are covered entities under the Health Insurance Portability and Accountability Act of August 1996 or HIPAA. As part of the operation of our business, we provide reimbursement assistance to certain of our customers and as a result we act in the capacity of a business associate with respect to any patient-identifiable medical information, or PHI, we receive in connection with these services. We and our customers must comply with a variety of requirements related to the handling of patient information, including laws and regulations protecting the privacy, confidentiality and security of PHI. The provisions of HIPAA require our customers to have business associate agreements with us under which we are required to appropriately safeguard the PHI we create or receive on their behalf. Further, we and our customers are required to comply with HIPAA security regulations that require us and them to implement certain administrative, physical and technical safeguards to ensure the confidentiality, integrity and availability of electronic PHI, or EPHI. We are required by regulation and contract to protect the security of EPHI (electronic protected health information) that we create, receive, maintain or transmit for our customers consistent with these regulations. To comply with our regulatory and contractual obligations, we may have to reorganize processes and invest in new technologies. We also are required to train personnel regarding HIPAA requirements. If we, or any of our employees or consultants, are unable to maintain the privacy, confidentiality and security of the PHI that is entrusted to us, we and/or our customers could be subject to civil and criminal fines and sanctions and we could be found to have breached our contracts with our customers. Under the Health Information Technology for Economic and Clinical Health Act, or HITECH Act, and recent omnibus revisions to the HIPAA regulations, we are directly subject to HIPAA’s criminal and civil penalties for breaches of our privacy and security obligations and are required to comply with security breach notification requirements. The direct applicability of the HIPAA privacy and security provisions and compliance with the notification requirements requires us to incur additional costs and may restrict our business operations.

~~Many, if not all of our customers, are covered entities under the Health Insurance Portability and Accountability Act of August 1996 or HIPAA~~U. As part of the operation of our business, we provide reimbursement assistance to certain of our customers and as a result we act in the capacity of a business associate with respect to any patient-identifiable medical information, or PHI, we receive in connection with these servicesS. WeGovernment and our customers must comply with a variety of requirements related to the handling of patient information, including laws and regulations protecting the privacy, confidentiality and security of PHI. The provisions of HIPAA require our customers to have business associate agreements with us under which we are required to appropriately safeguard the PHI we create or receive on their behalf. Further, we and our customers are required to comply with HIPAA security regulations that require us and them to implement certain administrative, physical and technical safeguards to ensure the confidentiality, integrity and availability of electronic PHI, or EPHI or electronic protected health information. We are required by regulation and contract to protect the security of EPHI that we create, receive, maintain or transmit for our customers consistent with these regulations. To comply with our regulatory and contractual obligations, we may have to reorganize processes and invest in new technologies. We also are required to train personnel regarding HIPAA requirements. If we, or any of our employees or consultants, are unable to maintain the privacy, confidentiality and security of the PHI that is entrusted to us, we and/or our customers could be subject to civil and criminal fines and sanctions and we could be found to have breached our contracts with our customers. Under the Health Information Technology for Economic and Clinical Health Act, or HITECH Act, and recent omnibus revisions to the HIPAA regulations, we are directly subject to HIPAA’s criminal and civil penalties for breaches of our privacy and security obligations and are required to comply with security breach notification requirements. The direct applicability of the HIPAA privacy and security provisions and compliance with the notification requirements requires us to incur additional costs and may restrict our business operations.Regulation

US Government Regulation

Government authorities in the United States and other countries extensively regulate, among other things, the research, development, testing, manufacture, labeling, promotion, advertising, distribution and marketing of our product, which is a medical device. In the United States, the FDA regulates medical devices under the Federal Food, Drug, and Cosmetic Act and implementing regulations. Failure to comply with the applicable FDA requirements, both before and after approval, may subject us to administrative and judicial sanctions, such as a delay in approving or refusal by the FDA to approve pending applications, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, administrative fines or criminal prosecution.

Unless exempted by regulation, medical devices may not be commercially distributed in the United States until they have been registered, cleared or approved by the FDA. Medical devices are classified into one of the three classes, Class I, II or III, on the basis of the controls necessary to reasonably assure their safety and effectiveness. ~~Class~~Our IItests ~~devices,~~have ~~the~~been ~~classification~~ assigned toModerate ~~our~~Complexity ~~two~~by ~~tests~~CLIA ~~for~~(Clinical ~~lactoferrin~~Laboratory ~~and~~Improvement ~~IgE,~~Amendments ~~are~~of ~~subject~~1988). This law requires any facility performing examination of human specimens for diagnosis to ~~general~~be ~~controls,~~certified ~~such~~by asthe ~~labeling,~~Department ~~pre-market~~of ~~notification~~Health and ~~adherence~~Human Services to ~~good~~be ~~manufacturing~~safe ~~practices~~and effective. ~~Laboratories~~The assignment of Moderate Complexity to our tests requires laboratories or sites that perform our tests ~~need~~ to have a CLIA certificate, ~~will~~to be inspected, and ~~must~~to meet the CLIA quality standards.

~~After~~18 aTable device receives 510(k) clearance, any modification to the device that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, would require a new 510(k) clearance or an approval of a Premarket Approval, or PMA. A PMA is the FDA process of scientific or regulatory review to evaluate the safety and effectiveness of Class II medical devices which are those devices which support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Although the FDA requires the manufacturer to make the initial determination regarding the effect of a modification to the device that is subject to 510(k) clearance, the FDA can review the manufacturer’s determination at any time and require the manufacturer to seek another 510(k) clearance or an approval of a PMA. Contents

~~CLIA~~After isa ~~intended~~device toreceives ~~ensure~~510(k) ~~the~~clearance, ~~quality~~any ~~and~~modification ~~reliability~~to ~~of clinical laboratories in~~ the ~~United~~device ~~States~~that bycould ~~mandating~~significantly ~~specific~~affect ~~standards~~its insafety ~~the~~or ~~areas of personnel qualifications~~effectiveness, ~~administration,~~or ~~and~~that ~~participation~~would inconstitute ~~proficiency~~a ~~testing,~~major ~~patient~~change ~~test~~in ~~management,~~its ~~quality~~intended ~~control~~use, ~~quality~~would ~~assurance~~require ~~and~~a ~~inspections.~~new ~~The~~510(k) ~~regulations~~clearance ~~promulgated~~or ~~under~~an ~~CLIA~~approval ~~establish three levels~~ of in ~~vitro diagnostic~~a ~~tests:~~Premarket ~~(1)~~Approval, ~~waived;~~or ~~(2) moderately complex; and (3) highly complex~~PMA. ~~The~~A ~~standards~~PMA ~~applicable~~is ~~to a clinical laboratory depend on~~ the ~~level~~FDA process of ~~diagnostic~~scientific ~~tests~~or itregulatory ~~performs.~~review Ato ~~CLIA~~evaluate ~~waiver~~the issafety ~~available~~and toeffectiveness ~~clinical~~of ~~laboratory~~Class ~~test~~III ~~systems~~medical ifdevices ~~they~~which ~~meet~~are ~~certain~~those ~~requirements~~devices ~~established~~which bysupport ~~the~~or ~~statute.~~sustain ~~Waived~~human ~~tests~~life, are ~~simple~~of ~~laboratory~~substantial ~~examinations~~importance ~~and~~in ~~procedures~~preventing ~~employing~~impairment ~~methodologies~~of ~~that~~human ~~are~~health, soor ~~simple~~which ~~and~~present ~~accurate~~a aspotential, tounreasonable ~~render~~risk ~~the likelihood~~ of ~~erroneous~~illness ~~results negligible~~ or ~~pose~~injury. noAlthough ~~reasonable~~the ~~risk~~FDA ofrequires ~~harm~~the manufacturer to ~~patients~~make if the ~~examinations~~initial ordetermination ~~procedures~~regarding ~~are~~the ~~performed~~effect ~~incorrectly.~~of ~~These~~a ~~tests~~modification ~~are~~to ~~waived~~the ~~from~~device ~~regulatory~~that ~~oversight~~is ofsubject ~~the~~to ~~user~~510(k) ~~other~~clearance, ~~than~~ the ~~requirement~~FDA tocan ~~follow~~review the manufacturer’s ~~labeling~~determination ~~and~~at ~~directions~~any ~~for~~time ~~use.~~and Werequire ~~intend~~the manufacturer to ~~file~~seek aanother ~~CLIA~~510(k) ~~waiver~~clearance ~~application~~or ~~for~~an ~~the~~approval ~~AXIM~~of ~~Eye~~a ~~System~~PMA.

24CLIA ~~Table~~is intended to ensure the quality and reliability of ~~Contents~~clinical laboratories in the United States by mandating specific standards in the areas of personnel qualifications, administration, and participation in proficiency testing, patient test management, quality control, quality assurance and inspections. The regulations promulgated under CLIA establish three levels of in vitro diagnostic tests: (1) waived; (2) moderately complex; and (3) highly complex. The standards applicable to a clinical laboratory depend on the level of diagnostic tests it performs. A CLIA waiver is available to clinical laboratory test systems if they meet certain requirements established by the statute. Waived tests are simple laboratory examinations and procedures employing methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible or to pose no reasonable risk of harm to patients if the examinations or procedures are performed incorrectly. These tests are waived from regulatory oversight of the user other than the requirement to follow the manufacturer’s labeling and directions for use. We intend to file waiver applications with the FDA for the AXIM Eye System.

Regardless of whether a medical device requires FDA clearance or approval, a number of other FDA requirements apply to the device, its manufacturer and those who distribute it. Device manufacturers must be registered and their products listed with the FDA, and certain adverse events and product malfunctions must be reported to the FDA. The FDA also regulates the product labeling, promotion and, in some cases, advertising of medical devices. In addition, manufacturers and their suppliers must comply with the FDA’s quality system regulation which establishes extensive requirements for quality and manufacturing procedures. Thus, suppliers, manufacturers and distributors must continue to spend time, money and effort to maintain compliance, and failure to comply can lead to enforcement action. The FDA periodically inspects facilities to ascertain compliance with these and other requirements.

Environmental Matters

No significant pollution or other types of hazardous emission result from our current operations, and we do not anticipate that our operations will be materially affected by federal, state or local provisions concerning environmental controls. Our costs of complying with environmental, health and safety requirements have not been material. Furthermore, compliance with federal, state and local requirements regulating the discharge of materials into the environment, or otherwise relating to the protection of the environment, have not had, nor are they expected to have, any material effect on the capital expenditures, earnings or competitive position of the Company. However, we will continue to monitor emerging developments in this area.

Employees

As of December 31, ~~2022~~2023, we had six full-time employees and ~~three~~one part-time ~~employees~~employee. We also allow and utilize the services of independent contractors. Management believes that we have a good relationship with our employees.

Company Website

We maintain a corporate Internet website at: www.aximbiotech.com ~~and an eye care-related website at: www~~.~~aximeye.com.~~ The contents of our website are not incorporated ininto or otherwise are to be regarded as part of this Report.

We file reports with the Securities and Exchange Commission (“SEC”), which are available on our website free of charge. These reports include annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, “Section 16” filings on Form 3, Form 4, and Form 5, and other related filings, each of which is provided on our website as soon as reasonably practical after we electronically file such materials with or furnish them to the SEC. In addition, the SEC maintains a website (www.sec.gov) that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC, including the Company.

~~Item~~19 ~~1A.~~Table ~~Risk~~of ~~Factors~~Contents

~~Investing in our common stock involves a high degree of risk~~I. ~~You should carefully consider the risks described below, as well as the other information in this Annual Report on Form 10~~TL-K,66 ~~including~~LLC ~~our~~Convertible ~~financial~~Notes ~~statements~~Modification and ~~the~~Default ~~related~~Waiver notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” before deciding whether to invest in our common stock. The occurrence of any of the events or developments described below could harm our business, financial condition, operating results, and growth prospects. In such an event, the market price of our common stock could decline, and you may lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.Agreement

~~Risk~~On ~~Factor~~January ~~Summary~~23, 2023, AXIM Biotechnologies, Inc. (the “Company”) and TL-66 LLC entered into a Convertible Notes Modification and Default Waiver Agreement (“Waiver Agreement”) in order to modify and cure defaults on various notes issued by the Company and its subsidiaries to TL-66 as summarized below.

~~Below~~(a) isFor afive ~~summary~~senior ofsecured convertible notes, as amended, issued by the ~~principal~~Company ~~factors~~to ~~that~~TL-66, ~~make~~aggregate anface ~~investment~~value inof ~~our~~$934,478 ~~common~~(the ~~stock~~"Secured ~~speculative~~Notes"), orwhich ~~risky.~~are ~~This~~currently ~~summary~~in ~~does~~default, ~~not~~TL-66 ~~address~~agreed to waive and forfeit all ofinterest accrued on the ~~risks~~Secured ~~that~~Notes wethrough ~~face.~~December ~~Additional~~31, ~~discussion~~2022, in the aggregate amount of $216,572. In addition, all prior defaults on the ~~risks~~Secured ~~summarized~~Notes inwere ~~this~~waived ~~risk~~through ~~factor~~January ~~summary~~23, 2023, and ~~other~~the ~~risks~~next ~~that~~interest wepayments ~~face,~~due ~~can~~on beeach ~~found~~of ~~below~~the ~~and~~Secured ~~should~~Notes bewas ~~carefully~~extended ~~considered~~from April 1, ~~together~~2023, ~~with~~to ~~other~~July ~~information~~1, ~~included~~2023. inAll ~~our~~of ~~December~~the ~~other~~Secured ~~filings~~Notes ~~with~~pays semi-annual interest at the ~~Securities~~rate of 3.5% per annum on each October and ~~Exchange~~April ~~Commission~~1st until maturity of October 1, 2029. In addition, the conversion price for each of the Secured Notes was reduced from $0.2201 to $0.04.

☐(b) ~~Even~~For ~~though~~a convertible note issued by the ~~Axim~~Company ~~Eye~~to ~~System~~TL-66, ~~has~~face ~~received~~value $365,931 (the "TL-66 Note"), TL-66 agreed to waive and forfeit all ~~regulatory~~interest ~~approvals~~accrued on the Convertible Notes through January 27, 2023, in the ~~United~~aggregate ~~States~~amount of $11,190.96 itand ~~may~~to ~~never~~waive beall ~~successfully~~prior ~~commercialized~~defaults on the TL-66 Note through January 23, 2023.The ☐TL-66 WeNote ~~have~~pays ~~incurred~~annual ~~significant~~interest ~~losses~~at ~~since~~the ~~inception~~rate ~~and~~of ~~anticipate~~3.0% ~~that~~per weannum ~~will~~on ~~incur~~each ~~continued~~January ~~losses~~27 ~~for~~until maturity on January 27, 2032 and is convertible into the ~~foreseeable~~Company's ~~future~~common stock at a conversion price of $0.10.

25(c) ~~Table~~For a convertible note issued by the Company's wholly-owned subsidiary, Sapphire Biotech, Inc, to TL-66, face value $190,000 (the "Sapphire Note"), TL-66 agreed to waive and forfeit all interest accrued on the Sapphire Note through December 31, 2022, in the amount of ~~Contents~~$17,115.84 and to waive all prior defaults on the Sapphire Note through January 23, 2023. The Sapphire Note pays annual interest each December 31st at the rate of 3.0% per annum until maturity on December 31, 2034 and is convertible into the Company's common stock at a conversion price of $0.03166667. In addition, TL-66 has the right to require the Company to assume the Sapphire Note at any time upon demand.

~~☐ We will require substantial additional funding, which may not be available to us on acceptable terms, if at all~~II. IfJohn ~~we fail to raise the necessary additional capital, we may be unable to complete the development and commercialization of our product candidates or continue our development programs~~W. ☐Huemoeller ~~Economic~~II ~~uncertainty~~Settlement and capital markets disruption, which has been significantly impacted by geopolitical instability due to the ongoing military conflict between Russia and Ukraine, could harm our financial condition and results of operations. ☐ We may be adversely affected by the effects of inflation. ☐ We will face challenges in bringing Axim Eye System to market in the United States and may not succeed in executing our business plan. ☐ Our near-term success is highly dependent on the success of the Axim Eye System, and we cannot be certain that it will be successfully commercialized in the United States. ☐ Our business is subject to health care industry and government cost-containment measures that could result in reduced sales of our Axim Eye System. ☐ If we are subject to regulatory enforcement action as a result of our failure to comply with regulatory requirements, our commercial operations would be harmed. ☐ If we are unable to fully comply with federal and state “fraud and abuse laws,” we could face substantial penalties, which may adversely affect our business, financial condition and results of operations. ☐ If we fail to comply with contractual obligations and applicable laws and regulations governing the handling of patient identifiable medical information, we could suffer material losses or be adversely affected by exposure to material penalties and liabilities. ☐ We may face future product liability claims. ☐ If we do not introduce new commercially successful products in a timely manner, our products may become obsolete over time, customers may not buy our products and our revenue and profitability may decline. ☐ We rely on a limited number of suppliers of each of the key components of the Axim Eye System and are vulnerable to fluctuations in the availability and price of our suppliers’ products and services. ☐ We face intense competition, and our failure to compete effectively could have a material adverse effect on our results of operations. ☐ The regulatory approval processes of the FDA, and comparable foreign authorities are lengthy, time consuming and unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed. ☐ We may expend our limited resources to pursue a particular product, product candidate or indication, and may fail to capitalize on products, product candidates or indications that may be more profitable or for which there is a greater likelihood of success. ☐ Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any. ☐ We rely on third parties to conduct our preclinical and clinical trials. If these third parties do not successfully perform their contractual legal and regulatory duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed. ☐ We may not be able to manufacture our products or product candidates in commercial quantities, which would prevent us from commercializing our products and product candidates.Agreement

☐On ~~Our~~January ~~failure to successfully discover~~23, ~~acquire~~2023, ~~develop~~the ~~and~~Company ~~market~~entered ~~additional~~into ~~product~~a ~~candidates~~“Settlement orAgreement” ~~approved~~with ~~products~~its ~~would~~Chief ~~impair~~Executive ~~our~~Officer, ~~ability~~John ~~to grow~~W. ☐Huemoeller ~~Our~~II ~~commercial~~(the ~~success~~"Executive") ~~depends~~regarding ~~upon us attaining significant market acceptance of our product candidates~~$512,500 ~~if approved for sale, among ophthalmologists, physicians, patients, healthcare payors and major operators~~ of ~~cancer~~accrued and ~~other~~unpaid ~~clinics.~~salary ☐owed ~~Reimbursement may be limited or unavailable in certain market segments for our product candidates, which could make it difficult for us~~ to ~~sell our products profitably. ☐ Our collaborations depend upon~~ the ~~efforts~~Executive ofthrough ~~third~~December ~~parties to fund and manage the development of many of our potential product candidates~~31, ~~and~~2022 ~~failure of those third-party collaborators to assist or share in~~ (the ~~costs~~"Amount ~~of product development could materially harm our business, financial condition and results of operations~~Due").

26(a) ~~Table~~$250,000 of ~~Contents~~the Amount Due will be paid by issuing to Executive a convertible note, face value $250,000 (the "Executive Note"). The Executive Note is unsecured, shall pay interest annually at the rate of 4% per annum with the first interest payment beginning on January 1, 2024, and each January 1st thereafter until maturity on January 1, 2033, and shall have a conversion price of $0.01.

☐(b) IfExecutive weshall ~~are~~waive/forfeit ~~unable~~$50,000 toof ~~retain~~the ~~and~~Amount ~~recruit~~Due. ~~qualified~~The ~~scientists~~remaining ~~and~~balance ~~advisors, or if any~~ of ~~our key executives~~$212,500 ~~key~~of ~~employees~~the orAmount ~~key~~Due ~~consultants~~($512,500 ~~discontinues~~minus ~~his or her employment or consulting relationship with us~~$250,000 itfor ~~may delay our development efforts or otherwise harm our business. We will need to increase~~ the ~~size~~Executive ofNote ~~our~~= ~~company~~$262,500 ~~and~~minus ~~may~~$50,000 ~~not~~waiver ~~effectively~~= ~~manage our growth. ☐ We may become involved in the future~~$212,500) inshall ~~disputes~~not ~~and~~be ~~other~~payable ~~legal~~at orany ~~regulatory~~time ~~proceedings~~prior ~~that,~~to ifJuly ~~adversely decided or settled~~1, ~~could materially and adversely affect our business~~2023, ~~financial condition~~ and ~~results~~Executive ofshall ~~operations. ☐ We~~ have ~~acquired,~~no ~~and~~right ~~may~~prior into ~~the~~July ~~future acquire~~1, ~~assets,~~2023 ~~businesses~~to ~~and~~seek ~~technologies~~payment ~~as part~~ of ~~our~~the ~~business~~remaining ~~strategy~~balance. If ~~we acquire companies or technologies~~ in the ~~future,~~reasonable ~~they~~discretion ~~could~~of ~~prove difficult to integrate, disrupt our business, dilute stockholder value, and adversely affect our operating results and~~ the ~~value~~Board of ~~our~~Directors ~~common~~full ~~stock.~~payment ☐of ~~Any~~the ~~acquisitions~~remaining webalance ~~make~~of ~~could~~the ~~disrupt~~Amount ~~our~~Due ~~business and seriously harm our financial condition. ☐ Our long-term success depends~~ on ~~intellectual~~July ~~property protection; if our intellectual property rights are invalidated or circumvented~~1, ~~our~~2023 ~~business will be adversely affected. ☐ If any of our trade secrets~~($212,500) ~~know-how~~is ortoo ~~other~~burdensome ~~proprietary~~for ~~information is disclosed,~~ the ~~value~~Company's ofworking ~~our~~capital ~~trade secrets, know-how and other proprietary rights would be significantly impaired and our business and competitive~~ position ~~would~~at ~~suffer. ☐ Claims~~ that ~~we infringe upon the rights of third parties may give rise to costly and lengthy litigation~~time, ~~and~~then weExecutive ~~could~~will beeither ~~prevented~~grant ~~from~~an ~~selling~~additional ~~products,~~3-month ~~forced~~extension tofor ~~pay~~the ~~damages,~~payment ~~and defend against litigation. ☐ If we breach any~~ of the ~~agreements~~remaining ~~under~~Amount ~~which~~Due we license commercialization rights to our product candidates from third parties, we could lose license rights that are important to our business. ☐ From time to time we may need to license patents, intellectual property and proprietary technologies from third parties, which may be difficult or ~~expensive~~engage ~~to obtain. ☐ The market price of our common stock may fluctuate significantly, and investors~~ in ~~our~~good ~~common~~faith ~~stock~~discussions ~~may~~with ~~lose~~the ~~all~~Board ~~or a part of their investment. ☐ Insiders have substantial influence over us and could delay or prevent a change~~ in ~~corporate~~order ~~control. ☐ We have never paid cash dividends and do not expect~~ to ~~pay~~enter ~~cash~~into ~~dividends~~a inpayment ~~the~~plan ~~foreseeable~~for ~~future. Any return on investment may be limited to~~ the ~~value~~remaining ofAmount ~~our common stock. ☐ We have issued preferred stock with designations~~Due, ~~rights~~or ~~and~~a ~~preferences~~combination ~~that are superior to that~~ of ~~our common stock, and we may issue additional shares of preferred stock in the future~~both.

~~Risks~~(c) ~~Related~~Executive agreed to ~~Our~~a ~~Financial~~$55,000 ~~Position~~reduction ~~and~~in ~~Capital~~salary ~~Requirements~~for the period of January 1, 2023 through June 30, 2023 (from $175,000 for the period reduced to $120,000). After June 30, 2023, Executive's salary shall be reinstated to the full amount prior to the reduction.

We20 ~~are~~Table ~~an early stage company subject to significant risks and uncertainties, including the risk that we or our partners may never develop, obtain regulatory approval or market certain~~ of ~~our product candidates or generate product related revenues.~~Contents

We are primarily an early stage biotechnology company that began operating in 2010, but did not commence research and development activities with respect to our current business segments until in 2019 or laterIII. ~~Medical~~MMI ~~device~~Convertible ~~development~~Note isModification ~~a highly speculative undertaking~~ and ~~involves~~Default aWaiver substantial degree of risk. There is no assurance that certain of our product candidates in development will be suitable for diagnostic or therapeutic use, or that we will be able to identify and isolate therapeutic product candidates, or develop, market and commercialize these candidates. Even if we are able to commercialize our product candidates, there is no assurance that these candidates would generate revenues or that any revenues generated would be sufficient for us to become profitable or thereafter maintain profitability. Agreement

~~The~~On ~~Axim~~January ~~Eye~~23, ~~System~~2023, ~~is currently our only FDA approved product. We anticipate launching sales in~~ the ~~United~~Company ~~States~~and inMedical ~~the~~Marijuana, ~~second~~Inc or("MMI") ~~third~~entered ~~quarter~~into ofa ~~2023~~Convertible toNote ~~those~~Modification ~~reference~~ and ~~physician~~Default ~~operated~~Waiver ~~laboratories~~Agreement ~~with Clinical Laboratory Improvement Act~~ (“~~CLIA~~MMI Modification Agreement”) ~~Class II certifications. Although the Axim Eye System has received all necessary regulatory approvals~~ in ~~the~~order ~~United~~to ~~States,~~modify itand ~~may~~cure ~~never be successfully commercialized. If~~ the ~~Axim~~default ~~Eye System or any~~ of ~~our~~a ~~other~~convertible ~~products~~note, ~~are~~as ~~not successfully commercialized~~amended, weface ~~may~~value ~~not~~$4 bemillion, ~~able~~issued toby ~~generate enough revenue to become profitable or continue our operations. Any failure of~~ the ~~Axim~~Company ~~Eye System~~ to beMMI ~~successfully commercialized in~~ (the ~~United~~"MMI ~~States~~Convertible ~~could~~Note") ~~have~~as aset ~~material~~forth ~~adverse effect on our business, operating results, financial condition and cash flows and could result in a substantial decline in the price of our common stock~~below.

27(a) ~~Table~~MMI agreed to waive and forfeit all interest accrued on the MMI Convertible Note through December 31, 2022, in the amount of ~~Contents~~$261,536.96, and to waive all prior defaults through January 23, 2023. The MMI Convertible Note was further modified so that interest shall accrue at the original rate of 3.5% per annum through June 30, 2023, and payable on that date. Thereafter interest will be payable on a monthly basis beginning on August 1, 2023. In addition, the conversion price for the MMI Convertible Note was reduced from $0.25 to $0.075.

WeOn ~~have~~January ~~incurred~~23, ~~significant~~2023, ~~losses~~the ~~since~~Company ~~inception~~issued ~~and~~a ~~anticipate~~$250,000 ~~that~~unsecured weconvertible ~~will~~note ~~incur~~as ~~continued~~more ~~losses~~fully ~~for~~described ~~the~~in ~~foreseeable~~Item ~~future~~1.01 II. (a) above, which is incorporated by reference.

AsOn ofMay ~~December 31~~23, ~~2022 and 2021~~2023, ~~we had an accumulated deficit related to~~ our ~~continuing~~Chief ~~operations~~Executive ofOfficer ~~$64,125,176~~appointed ~~and~~Kurt ~~$57,882,227,~~Phinney ~~respectively.~~as We continue to incur significant research and development and other expenses related to our ongoing operations. We have incurred operating losses since our inception, expect to continue to incur significant operating losses for the foreseeable future, and we expect these losses to continue as we identify and advance other product candidates, (i) incur higher salary, lab supply and infrastructure costs incurred in connection with supporting all of our programs, (ii) expand our corporate, development and manufacturing infrastructure, (iii) support our subsidiariesCompany’~~, including Sapphire’~~s, ~~pre-clinical~~Chief ~~development~~Operating ~~and commercialization efforts and (ix) the acquisition and further development of the eye care tests~~Officer. As such, we are subject to all risks incidental to the development of new biopharmaceutical products and related companion diagnostics, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. Our prior losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders’ equity and working capital.

WeMr. ~~will~~Phinney’s ~~require~~experience ~~substantial~~includes ~~additional~~serving ~~funding,~~as ~~which~~the ~~may~~Quality ~~not~~and beRegulatory ~~available~~Manager toof usGreat onLakes ~~acceptable~~Cheese; ~~terms,~~Sr. ifDirector atof ~~all~~Operations for Rapid Pathogen Screening; and R&D Scientist & Manufacturing Manger for Immunetics, Inc. IfMr. wePhinney ~~fail~~received tomultiple ~~raise~~honors and medals serving as a Corpsman in the ~~necessary~~United ~~additional~~States ~~capital~~Coast Guard (1989-1995); Principal Consultant for ICA Biotechnology, weVP ~~may~~of beOperations ~~unable~~for toLumos ~~complete~~Diagnostics ~~the~~from ~~development~~(2018–2022), VP of Operations for Versea Health (2022-2023) and ~~commercialization~~Principal Consultant for Accalle Group (2022-Present). In addition, Mr. Phinney holds USPTO Patent 20050277185: Chemistry, Molecular Biology, and Microbiology Binding Assay Device and has presented Modification of ~~our~~a ~~product~~Commercial ~~candidates~~HIV-1 orEnzyme ~~continue~~Immunoassay ~~our~~for ~~development~~Identification ~~programs~~of Recent HIV-1 Infection, at the annual Conference of Retrovirus and Opportunistic Infections.

~~Our~~Mr. ~~operations~~Phinney ~~have~~will ~~consumed~~serve ~~substantial~~for ~~amounts~~a minimum of ~~cash~~six ~~since~~months ~~inception.~~and, Wepursuant ~~expect~~ to ~~significantly~~a ~~increase~~Consulting ~~our~~Agreement ~~spending~~with tothe ~~advance~~Company, ~~our~~will ~~product~~be ~~candidates~~compensated ~~and~~with ~~launch~~an ~~and~~option ~~commercialize~~to ~~any~~purchase ~~product~~up ~~candidates~~to ~~for~~2,000,000 ~~which~~shares weof ~~may~~the ~~receive~~Company’s ~~regulatory~~common ~~approval.~~stock Weregistered ~~will~~on ~~require~~Form ~~additional~~S-8 ~~capital for~~ (the ~~further~~“Option ~~development~~Shares”) ~~and~~vesting ~~commercialization~~at ofa ~~our~~rate ~~product~~1/6 ~~candidates,~~of asthe ~~well~~Option asShares toevery ~~fund~~30 ~~our other operating expenses and capital expenditures~~days.

AsOn aMay ~~result~~23, 2023, AXIM Biotechnologies, Inc. (the “Company”) issued five (5) convertible promissory notes in the aggregate principal amount of ~~our~~$575,000 ~~recurring~~(the ~~losses~~“Convertible ~~from~~Notes”) ~~operations~~to certain investors. Four (4) of the Convertibles Notes, ~~recurring~~for ~~negative~~a combined principal amount of $325,000, were issued in exchange for cash ~~flows~~of ~~from~~$325,000. One ~~operations~~(1) ~~and~~of ~~substantial~~the ~~cumulative~~Convertible ~~losses~~Note, ~~there~~in isthe ~~uncertainty~~principal ~~regarding~~amount ~~our~~of ~~ability~~$250,000, towas ~~maintain~~issued ~~liquidity~~as ~~sufficient~~repayment of five cash advances made to ~~operate~~the ~~our~~Company, ~~business~~for ~~effectively~~a total of $250,000, ~~which~~during ~~raises~~the ~~substantial~~period ~~doubt~~between ~~about~~January ~~our~~12, ~~ability~~2023, toand ~~continue~~April 11, 2023. Each of the Convertibles Notes has the same terms as follows: (a) ~~going~~unsecured; ~~concern~~(b) interest rate of 3.75% Ifper weannum, ~~are~~payable ~~unsuccessful~~annually inbeginning ~~our~~on ~~efforts~~May to23, ~~raise~~2024; ~~additional~~(c) ~~capital~~maturity date of May 23, we2033, (d) the Company may benot ~~required~~prepay tothe ~~significantly~~Convertibles ~~reduce~~Notes, either in whole or ~~cease~~in ~~operations.~~part, ~~The~~without ~~report~~the express written consent of ~~our~~holder; ~~independent~~€ ~~registered~~convertible ~~public~~at ~~accounting~~any ~~firm~~time, onin ~~our~~whole ~~audited~~or ~~financial~~in ~~statements~~part ~~for~~(subject to a 4.9% beneficial ownership blocker), at the ~~years~~option ~~ended~~of ~~December~~the 31holder, ~~2022~~into ~~and~~shares ~~2021~~of ~~included~~Company acommon ~~“going~~stock ~~concern”~~at ~~explanatory~~a ~~paragraph~~conversion ~~indicating~~price that ~~our~~is ~~recurring~~equal ~~losses~~to ~~from~~the ~~operations,~~lesser ~~negative~~of ~~working~~$0.01 ~~capital,~~or ~~recurring~~70% ~~negative~~of ~~cash~~the ~~flows~~average ~~from~~of ~~operations~~the ~~and~~two ~~substantial~~lowest ~~cumulative~~closing ~~net~~prices ~~losses~~of ~~raise~~the ~~substantial~~Company’s ~~doubt~~common ~~about~~stock ~~our~~in ~~ability~~the ten (10) trading days prior to ~~continue~~any particular conversion; and (f) if an Event of Default (as adefined ~~going~~in ~~concern~~the Convertibles Notes) occurs, the holder thereof may declare the entire balance of the note, including all accrued interest immediately due.

WeOn ~~cannot~~June be1, ~~certain~~2023, ~~that~~AXIM ~~additional~~Biotechnologies, ~~funding~~Inc., ~~will~~a beNevada ~~available~~corporation on(the ~~acceptable terms~~“Company”), ifentered atinto ~~all.~~an IfEquity wePurchase ~~are~~Agreement ~~unable~~(the to“Purchase ~~raise~~Agreement”) ~~additional~~with ~~capital~~an ininstitutional ~~sufficient~~accredited ~~amounts~~investor or(the on“Investor”), ~~terms~~pursuant ~~acceptable~~ to uswhich wethe ~~may~~Investor ~~have~~committed to ~~significantly~~purchase ~~delay,~~up ~~scale~~to ~~back~~$20,000,000 orof ~~discontinue~~ the ~~development~~Company’s orcommon ~~commercialization~~stock of(the ~~one or more of our product candidates~~“Financing”). WeCapitalized ~~may~~terms ~~also~~not ~~seek~~defined ~~collaborators~~herein ~~for~~shall ~~one~~have orthe ~~more~~meaning ofset ~~our~~forth ~~current~~in orthe ~~future~~Purchase ~~product~~Agreement, ~~candidates~~a atcopy anof ~~earlier~~which ~~stage~~is ~~than~~attached ~~otherwise~~as ~~would~~Exhibit ~~be desirable or on terms that are less favorable than might otherwise be available~~10.1 ~~Any~~to ofthis ~~these~~Current ~~events~~Report ~~could~~on ~~significantly~~Form ~~harm~~8-K ~~our~~and ~~business,~~is ~~financial~~incorporated ~~condition~~by ~~and~~reference ~~prospects~~herein.

~~Our~~21 ~~future~~Table ~~capital~~of ~~requirements will depend on many factors, including:~~Contents

☐Pursuant to the ~~commercial~~Financing, ~~acceptance~~upon offiling ~~our~~and ~~two~~effectiveness ~~FDA~~of ~~cleared~~a ~~diagnostic~~Registration ~~tests~~Statement ~~for~~on ~~dye~~Form ~~eye~~S-1, ~~disease~~and ☐provided ~~the~~that ~~need~~certain toother ~~preform~~closing ~~clinical~~conditions ~~studies~~are ~~for~~met, ~~FDA~~the ~~clearance~~Company ofshall ~~our~~have ~~new~~the ~~MMP-9~~right, ~~test~~but ☐not the ~~number~~obligation, ofto ~~product~~direct ~~candidates we pursue; ☐~~ the ~~time~~Investor ~~and~~to ~~costs~~purchase ~~involved~~shares inof ~~obtaining~~the ~~regulatory~~Company’s ~~approvals;~~common ☐stock (the ~~costs~~“Put ~~involved~~Shares”) inas ~~filing~~follows: ~~and~~(i) ~~prosecuting~~in ~~patent~~a ~~applications~~minimum ~~and~~amount ~~enforcing~~of ornot ~~defending~~less ~~patent~~than ~~claims; ☐ our plans to establish sales~~$10,000 ~~marketing~~ and~~/or~~ ~~manufacturing~~(ii) ~~capabilities;~~in ☐a ~~the~~maximum ~~effect~~amount of ~~competing~~$250,000; ~~technological~~provided, ~~and~~however, ~~market~~that ~~developments; ☐~~ the ~~terms~~number ~~and timing~~ of ~~any~~Put ~~collaborative,~~Shares ~~licensing and other arrangements~~ that wethe Company may ~~establish;~~direct ☐the ~~general~~Investor ~~market~~to ~~conditions~~purchase ~~for~~shall ~~offerings~~not ~~from~~exceed ~~biopharmaceutical~~300% ~~companies;~~of ☐the ~~our~~average ~~ability~~daily totrading ~~establish,~~volume ~~enforce~~in ~~and~~dollar ~~maintain~~amount ~~selected strategic alliances and activities required~~ for ~~product~~the ~~commercialization;~~Company’s ☐common ~~our~~stock ~~obligations~~during ~~under~~the ~~our~~ten ~~debt~~trading ~~arrangements;~~days ☐preceding the ~~time~~date ~~and~~that ~~costs involved in defending and enforcing our rights in various litigation matters; ☐~~ the ~~effect~~Company ofdelivers the ~~COVID-19~~put ~~pandemic;~~notice ~~and~~or ☐the ~~our~~maximum ~~revenues~~amount, ifunless ~~any,~~waived ~~from~~in ~~successful~~writing ~~development~~by ~~and~~the ~~commercialization~~Investor, ofin ~~our~~its ~~product~~sole ~~candidates~~discretion.

28At ~~Table~~any time, and from time to time, during the term of ~~Contents~~the Purchase Agreement (the “Commitment Period”), the Company may deliver a notice to Investor (the “Put Notice”) of its election to direct the Investor to purchase Put Shares, and the Company shall deliver such Put Shares to Investor via DWAC within two trading days thereafter. The Purchase Price of the Put Shares shall be 87.5% of the lowest traded price (as reported by Bloomberg Finance L.P.) during the ten consecutive trading days including and immediately prior to the settlement date of the sale (the “Valuation Period”). The closing of a Put Notice shall occur within one trading day following the end of the respective Valuation Period, whereby (i) the Investor shall deliver the investment amount to the Company by wire transfer of immediately available funds and (ii) the Investor shall return surplus Put Shares if the value of the Put Shares delivered to the Investor causes the Company to exceed the maximum commitment amount. The Company shall not deliver another Put Notice to the Investor within ten trading days of a prior Put Notice.

InThe ~~order~~right toof ~~carry~~the ~~out~~Company ~~our~~to ~~business~~issue ~~plan~~ and ~~implement~~sell ~~our~~the ~~strategy,~~Put weShares ~~anticipate~~to ~~that~~the weInvestor ~~will~~is ~~need~~subject to ~~obtain~~the ~~additional~~satisfaction ~~financing~~of ~~from~~certain ~~time~~closing toconditions, ~~time~~including, ~~and~~but ~~may~~not ~~choose~~limited to, ~~raise~~(i) ~~additional~~an ~~funds~~effective ~~through~~Registration ~~strategic~~Statement ~~collaborations,~~on ~~licensing~~Form ~~arrangements,~~S-1 ~~joint~~for ~~ventures,~~resale ~~public~~by orInvestor ~~private~~of ~~equity~~the orPut ~~debt financing~~Shares, ~~asset~~(ii) ~~sales,~~accuracy ~~government~~of ~~grants~~the orCompany’s ~~other~~representations ~~arrangements.~~and Wewarranties, ~~cannot~~(iii) bethe ~~sure~~Company’s ~~that~~performance ~~any~~under ~~additional~~the ~~funding,~~Purchase ifAgreement ~~needed,~~in ~~will~~all bematerial ~~available~~respects, on(iv) ~~terms~~no ~~favorable~~suspension toof ~~us,~~trading or atdelisting ~~all.~~of ~~Furthermore,~~the ~~any~~Company’s ~~additional~~common ~~equity~~stock, or(v) ~~equity-related~~limitation ~~financing~~of ~~may~~the beInvestor’s ~~dilutive~~beneficial ownership to ~~our~~no ~~stockholders,~~more ~~and~~than ~~debt~~4.99% orof ~~equity~~the ~~financing,~~Company’s ifissued ~~available,~~and ~~may~~outstanding ~~subject~~shares usof tocommon ~~restrictive~~stock, ~~covenants~~(vi) ~~and~~the ~~significant~~Company ~~interest~~maintaining ~~costs.~~its IfDWAC-eligible westatus, ~~obtain~~(vii) ~~funding~~the ~~through~~Company maintaining a ~~strategic~~sufficient ~~collaboration~~share ~~or licensing arrangement~~reserve, weand ~~may~~(viii) bethe ~~required~~minimum topricing ~~relinquish~~for ~~our~~the ~~rights~~Put toShares ~~certain~~must ofexceed ~~our product candidates or marketing territories~~$0.01.

~~Our~~Pursuant ~~inability~~ to ~~raise~~the ~~capital~~terms ~~when~~of ~~needed~~the ~~would~~Purchase ~~harm our business~~Agreement, ~~financial~~the ~~condition~~Company ~~and~~must ~~results~~file ofa ~~operations,~~Registration ~~and~~Statement ~~could~~which ~~cause~~relates ~~our~~to ~~stock~~the ~~price~~resale toby ~~decline~~Investor orof ~~require~~the ~~that~~Put weShares ~~wind~~as ~~down~~soon ~~our~~as ~~operations~~reasonably ~~altogether~~practicable.

WeEffective ~~are~~December ~~currently~~26, ~~operating~~2023, inAXIM aBiotechnologies, ~~period~~Inc. of(the ~~economic~~“Company”) ~~uncertainty~~entered ~~and~~into ~~capital~~a ~~markets~~Convertible ~~disruption,~~Note ~~which~~Purchase ~~has~~Agreement ~~been~~(the ~~significantly~~"Agreement") ~~impacted~~with byMedical ~~geopolitical~~Marijuana, ~~instability~~Inc ~~due~~(“MJNA”), tocurrently ~~the~~an ~~ongoing~~affiliate ~~military~~of ~~conflict~~the ~~between~~Company ~~Russia~~ and ~~Ukraine.~~one ~~Our~~of ~~business,~~its ~~financial~~largest ~~condition~~shareholders, ~~and~~for ~~results~~the purchase of ~~operations~~up ~~could~~to be$750,000 ~~materially~~face ~~adversely~~value ~~affected~~in byconvertible ~~any~~notes. Also, ~~negative~~effective ~~impact~~December on26, ~~the~~2023, ~~global~~MJNA ~~economy~~purchased ~~and~~its ~~capital~~first ~~markets~~convertible ~~resulting~~note, face ~~from~~value of $100,000, under the ~~conflict~~terms inof ~~Ukraine or~~the ~~any~~Agreement ~~other~~(the ~~geopolitical~~"Initial ~~tensions~~Note").

~~U.S.~~Under ~~and~~the ~~global~~terms ~~markets~~of ~~are~~the ~~experiencing~~Agreement, ~~volatility~~until ~~and~~June ~~disruption~~26, ~~following~~2025, MJNA has the ~~escalation~~option, ofbut ~~geopolitical~~not ~~tensions~~the ~~and~~obligation, to purchase up to $750,000 in convertible notes to be issued by the ~~start~~Company, ofwhich includes the ~~military~~Initial ~~conflict~~Note ~~between~~for ~~Russia~~$100,000. The ~~and~~notes ~~Ukraine~~shall bear interest at the rate of 5.25% per Onannum, ~~February~~which 24is payable annually beginning on December 26, ~~2022~~2024, aand ~~full-scale~~each ~~military~~year ~~invasion~~thereafter ofuntil ~~Ukraine~~maturity on December 26, 2033. Any notes acquired by ~~Russian~~MJNA ~~troops~~pursuant ~~was~~to ~~reported.~~the ~~Although~~Agreement (including the ~~length~~Initial ~~and~~Note) ~~impact~~are ofconvertible at any time prior to the ~~ongoing~~maturity ~~military~~date, ~~conflict~~at isthe ~~highly~~sole ~~unpredictable~~option of MJNA, into shares of the ~~conflict~~Company’s incommon ~~Ukraine could~~stock ~~lead~~at a conversion price equal to ~~market~~the ~~disruptions,~~lesser ~~including~~of ~~significant~~$0.01 ~~volatility~~or in70% ~~commodity~~of the average of the two lowest closing prices, ~~credit~~of ~~and~~the ~~capital~~Company’s ~~markets,~~common asstock ~~well~~in asthe ~~supply~~ten ~~chain~~(10) ~~interruptions~~trading days immediately preceding the date of conversion. WeNotwithstanding ~~are~~the ~~continuing~~foregoing, MJNA, shall not be permitted to ~~monitor~~convert ~~the~~any ~~situation~~note, or portion thereof, if such conversion would result in ~~Ukraine and~~beneficial ~~globally~~ownership ~~and~~of ~~assessing~~the Company by MJNA and its ~~potential~~affiliates ~~impact~~of onmore ~~our~~than ~~business~~4.9% of the outstanding Common Stock of the Company as of the date of conversion.

~~Additionally,~~The ~~the~~Company ~~recent~~sold ~~military conflict in Ukraine has led to sanctions and other penalties being levied by~~ the ~~United~~securities ~~States,~~referenced ~~European~~in ~~Union~~this ~~and~~Item ~~other countries against Russia~~1.01 ~~Additional~~in ~~potential~~reliance ~~sanctions~~upon ~~and~~an ~~penalties~~exemption ~~have~~from ~~also~~registration ~~been~~contained ~~proposed~~in ~~and/or~~Section ~~threatened.~~4(a)(2) ~~Russian~~of ~~military actions and~~ the ~~resulting~~Securities ~~sanctions~~Act ~~could adversely affect the global economy~~ and ~~financial~~Regulation ~~markets~~D ~~and~~promulgated ~~lead to instability and lack of liquidity in capital markets, potentially making it more difficult for us to obtain additional funds~~thereunder.

~~Although~~On ~~our~~February ~~business~~10, ~~has~~2022, ~~not~~the ~~been~~Company ~~materially~~paid ~~impacted~~in byfull the ~~ongoing~~remaining ~~military~~balance ~~conflict~~due ~~between~~on ~~Russian~~that ~~and~~certain ~~Ukraine~~convertible tonote ~~date,~~issued ~~it is impossible~~ to ~~predict~~GS ~~the~~Capital ~~extent~~Partners, toLLC, ~~which~~face ~~our~~value ~~operations~~$1,110,000 or(as ~~those~~amended, ofthe ~~our~~“GS ~~suppliers~~Note”). ~~and~~In ~~manufacturers,~~connection ~~will~~with bethe ~~impacted~~repayment, in the ~~short~~Company ~~and~~was ~~long~~required ~~term,~~to orpay ~~the~~accrued ~~ways~~interest in ~~which~~ the ~~conflict~~amount ~~may~~of ~~impact~~$21,875, ~~our~~by ~~business. The~~issuing ~~extent~~173,390 ~~and~~restricted ~~duration~~shares of the ~~military~~Company’s ~~action,~~common ~~sanctions~~stock ~~and~~pursuant ~~resulting market disruptions are impossible~~ to ~~predict, but could be substantial. Any such disruptions may also magnify~~ the ~~impact~~formula ofset ~~other~~forth ~~risks described~~ in ~~this~~the ~~Annual~~GS ~~Report~~Note.

WeIn ~~may~~March be2022, ~~adversely~~the ~~affected~~Company byissued ~~the~~624,290 ~~effects~~of its shares of ~~inflation~~ common stock pursuant to a stock purchase agreement for cash gross proceeds of $55,000.

~~Inflation has~~22 ~~the~~Table ~~potential to adversely affect our liquidity, business, financial condition and results~~ of operations by increasing our overall cost structure. The existence of inflation in the economy has resulted in, and may continue to result in, higher interest rates and capital costs, shipping costs, supply shortages, increased costs of labor, weakening exchange rates and other similar effects. As a result of inflation, we have experienced and may continue to experience, cost increases. Although we may take measures to mitigate the impact of this inflation, if these measures are not effective our business, financial condition, results of operations and liquidity could be materially adversely affected. Even if such measures are effective, there could be a difference between the timing of when these beneficial actions impact our results of operations and when the cost inflation is incurred.Contents

29In ~~Table~~January 2022 the company issued 7,000,000 of ~~Contents~~its shares in completion of its agreement with Advanced Tear Diagnostics regarding the acquisition of two 510(k) cleared medical devices.

~~Risks~~In ~~Related~~December 2019, a novel strain of coronavirus (“COVID-19”) was reported in Wuhan, China. The COVID-19 pandemic, as it was declared by the World Health Organization, has continued to ~~Our~~spread ~~Business~~and has already caused severe global disruptions. The extent of COVID-19’s effect on our operational and ~~Industry~~financial performance will depend on future developments, including the duration, spread and intensity of the pandemic, all of which are uncertain and difficult to predict considering the rapidly evolving landscape.

~~Our~~We ~~business~~expect ~~may~~COVID-19, bealong ~~subject~~with tothe ~~risks~~resulting ~~arising~~government-imposed ~~from~~restrictions ~~pandemic,~~on ~~epidemic~~businesses, orto negatively impact our operations due to decreased consumer demand as well as potential production and warehouse limitations which results in an ~~outbreak~~event or condition, before consideration of ~~diseases~~management’s plans, ~~such~~that could impact our ability to meet future obligations. We believe that our cash and cash equivalents on hand and these cost reduction measures, as needed, will provide sufficient liquidity to fund our operations for the ~~outbreak~~next 12 months from the issuance of ~~COVID-19.~~the consolidated financial statements.

IfSources ~~a pandemic, epidemic or outbreak~~ of ~~an infectious disease occurs in the United States or elsewhere, our business may be adversely affected.~~Capital

~~COVID-19~~We ~~has~~expect ~~spread~~to ~~worldwide~~sustain ~~and~~our ~~has~~working ~~resulted~~capital inneeds ~~government~~through ~~authorities~~shareholder ~~implementing~~loans, ~~numerous~~private ~~measures~~placements toand/or ~~try~~registered toofferings ~~contain~~of ~~it,~~our ~~such~~securities. asShareholder ~~travel~~loans ~~bans~~may ~~and~~be ~~restrictions,~~without ~~quarantines,~~stated ~~shelter-in-place~~terms ~~orders~~of ~~and~~repayment ~~shutdowns~~or interest. ~~These~~We ~~measures~~may ~~have~~consider ~~impacted,~~taking ~~and~~on ~~may~~any ~~further~~long-term ~~impact,~~or ~~our~~short-term ~~workforce~~debt ~~and~~from ~~operations,~~financial ~~the~~institutions ~~operations~~in ofthe ~~our~~immediate ~~partners,~~future. ~~and~~Shareholders ~~those~~loans ofmay ~~our~~be ~~suppliers.~~granted ~~Our~~from ~~critical~~time ~~business~~to ~~operations,~~time ~~including~~as ~~our~~required ~~headquarters,~~to ~~are~~meet ~~located~~current inworking ~~regions~~capital ~~which~~needs. We have ~~been~~no ~~impacted~~formal byagreement ~~COVID-19.~~that ~~Our~~ensures ~~suppliers~~that ~~and~~we ~~partners~~will ~~have~~receive ~~also~~such ~~been~~loans. ~~affected~~We ~~and~~ may ~~continue~~exhaust tothis besource ~~affected~~of byfunding ~~COVID-19~~at ~~related~~any ~~restrictions and closures~~time.

~~The~~During ~~spread of COVID-19 has caused us to modify our business practices as we comply with state mandated requirements for safety in~~ the ~~workplace~~next totwelve ~~ensure the health~~months, safety and well-being of our employees. These measures include personal protective equipment, social distancing, cleanliness of the facilities and daily monitoring of the health of employees in our facilities, as well as modifying our policies on employee travel and the cancellation of physical participation in meetings, events and conferences. We may take further actions as required by government authorities or that we ~~determine~~anticipate ~~are~~incurring incosts ~~the~~related ~~best interests of our employees, partners and suppliers. However, we have not developed a specific and comprehensive contingency plan designed~~ to address the challenges and risks presented by the COVID-19 pandemic and, even if and when we do develop such a plan, there can be no assurance that such plan will be effective in mitigating the potential adverse effects on our business, financial condition and results of operations.:

In(i) ~~addition,~~filing ~~while~~Exchange ~~the~~Act ~~extent~~reports; ~~and~~(ii) ~~duration~~contractual ofobligations; ~~the~~(iii) ~~COVID-19~~building ~~pandemic~~inventory ~~on the global economy and our business in particular is difficult to assess or predict, the pandemic has resulted in, and may continue to result in, significant disruption~~ of ~~global financial markets, which may reduce~~ our ~~ability~~approved todevices; ~~access~~(iii) ~~capital,~~clinical ~~which~~trials; ~~could negatively affect our liquidity. A recession or financial market correction resulting from the lack of containment~~ and ~~spread~~(iv) ofcontinued ~~COVID-19~~research ~~could impact overall technology spending, adversely affecting demand for our products, our business~~ and ~~the~~development ~~value~~ of our ~~common~~diagnostic ~~stock~~tests.

~~The~~We ~~ultimate~~believe ~~impact~~we ofwill ~~the~~be ~~COVID-19~~able ~~pandemic~~to ormeet athese ~~similar~~costs ~~health~~through ~~epidemic~~use isof ~~highly~~funds ~~uncertain~~in ~~and~~our ~~subject~~treasury, todeferral ~~change.~~of ~~The~~fees ~~extent~~by ofcertain ~~the~~service ~~impact~~providers ofand ~~the~~additional ~~COVID-19~~amounts, ~~pandemic~~as onnecessary, ~~our~~to ~~operational~~be ~~and~~loaned ~~financial~~to ~~performance,~~or ~~including~~invested in us by our ~~ability~~shareholders, tomanagement ~~execute~~or ~~our~~other ~~business~~investors. ~~strategies~~As ~~and~~of ~~initiatives~~the indate of the ~~expected~~period ~~time~~covered ~~frame~~by this report, ~~will~~we ~~depend~~have onlimited ~~future~~cash. ~~developments,~~There ~~including,~~are ~~but~~no ~~not~~assurances ~~limited~~that ~~to,~~we ~~the~~will ~~duration~~be ~~and~~able ~~continued~~to ~~spread~~secure ofany ~~the~~additional ~~pandemic,~~funding ~~its~~as ~~severity~~needed. Currently, ~~the~~however ~~actions~~our ability to ~~contain~~continue ~~the~~as ~~disease~~a orgoing ~~treat~~concern ~~its~~is ~~impact,~~dependent ~~further~~upon ~~related~~our ~~restrictions~~ability onto ~~travel,~~generate ~~all~~future ofprofitable ~~which~~operations ~~are uncertain~~ and/or ~~cannot~~to beobtain ~~predicted.~~the Annecessary ~~extended~~financing ~~period~~to ofmeet ~~economic~~our ~~disruption~~obligations asand arepay ~~result~~our ofliabilities ~~the~~arising ~~COVID-19~~from ~~pandemic~~normal ~~could~~business ~~have~~operations awhen ~~material~~they ~~negative~~come ~~impact~~due. onManagement’s ~~our~~plan ~~business,~~includes ~~results~~obtaining ofadditional ~~operations,~~funds ~~access~~by toequity ~~sources~~financing ofand/or ~~liquidity~~related ~~and~~party ~~financial~~advances; ~~condition~~however, ~~though~~there ~~the~~is ~~full~~no ~~extent~~assurance ~~and~~of ~~duration~~additional isfunding ~~uncertain~~being available.

~~Management~~Known isTrends actively monitoring the global situation on our financial condition, liquidity, operations, suppliers, industry and workforce. Given the daily evolution of the COVID-19 outbreak and the global responses to curb its spread, we are not able to estimate the effects of the COVID-19 outbreak on our results of operations, financial condition or ~~liquidity for fiscal year 2022.~~Uncertainties

We ~~will~~have ~~face~~seen ~~challenges~~some consolidation in ~~bringing~~ the ~~Axim~~pharmaceutical ~~Eye~~and ~~System~~biotechnology industries during economic downturns. These consolidations have not had a negative effect on us to ~~market~~date; however, should consolidations and downsizing in the ~~United~~industry ~~States~~continue ~~and~~to ~~may~~occur, ~~not~~those ~~succeed~~events incould ~~executing~~adversely impact our financial results and business ~~plan~~operations going forward.

~~There~~The ~~are~~potential ~~numerous~~for ~~risks~~growth ~~and uncertainties inherent~~ in ~~the development of~~ new ~~medical~~markets ~~technologies~~is uncertain. InWe ~~addition~~will tocontinue ~~our requirement for additional capital, our ability~~ to ~~bring~~explore ~~the~~these ~~Axim~~opportunities ~~Eye~~until ~~System~~such totime ~~market~~as inwe ~~the~~either ~~United~~generate ~~States~~sales ~~and~~or todetermine ~~execute~~that ~~our~~resources ~~business~~would ~~plan~~be ~~successfully~~more isefficiently ~~subject~~used ~~to the following risks, among others:~~elsewhere.

☐As ~~Our~~discussed ~~clinical~~in ~~trials~~this ~~may~~Annual ~~not~~Report, ~~succeed~~the world has been affected due to the COVID-19 pandemic. ~~Clinical~~The ~~testing~~pandemic ishas ~~expensive~~negatively ~~and~~impacted ~~can~~our ~~take~~business ~~longer~~in ~~than~~various ~~originally~~ways ~~anticipated.~~over ~~The~~the ~~outcomes~~last oftwo ~~clinical~~years, ~~trials~~including, ~~are~~more ~~uncertain~~recently, ~~and~~as ~~failure~~a ~~can~~result ~~occur~~of global supply chain constraints at ~~any~~least ~~stage~~partially ofattributable to the ~~testing~~pandemic. WeEven ~~could~~now ~~encounter~~as ~~unexpected~~the ~~problems~~pandemic has passed, ~~which~~there ~~could~~remains ~~result~~uncertainty inas ato ~~delay~~the ineffect ~~efforts~~of toCOVID-19 ~~complete~~on ~~clinical~~our ~~trials~~business ~~supporting~~in ~~our~~both ~~commercialization~~the ~~efforts~~short and long-term.

3023 Table of Contents

☐ The Axim Eye System is rated as CLIA Class II medical device, which requires our customers to be certified under CLIA requirements, including certain parallel state requirements. If our customers are unwilling or unable to comply with such requirements, it could have an adverse effect on our ability to market the Axim Eye System in the United States. We plan to file for a CLIA Waiver, however there is no guarantee that the FDA will grant such a Waiver.Inflation

☐Inflation ~~Our~~has ~~suppliers~~increased ~~and~~during wethe ~~will~~periods becovered ~~subject~~by this Annual Report, and is expected to ~~numerous~~continue ~~FDA~~to ~~requirements~~increase ~~covering~~for the ~~design,~~near ~~testing,~~future. ~~manufacturing~~Inflationary factors, ~~quality~~such ~~control,~~as ~~labeling,~~increases ~~advertising,~~in ~~promotion~~the cost of our products (and ~~export~~components ofthereof), ~~the~~interest ~~Axim~~rates, ~~Eye~~overhead ~~System~~costs and ~~other~~transportation ~~matters~~costs may adversely affect our operating results. IfAlthough we do not believe that inflation has had a material impact on our ~~suppliers~~financial position or weresults ~~fail~~of operations to ~~comply~~date, ~~with~~we ~~these~~may ~~regulatory~~experience ~~requirements,~~some effect in the ~~Axim~~near ~~Eye~~future ~~System~~(especially ~~could~~if beinflation ~~subject~~rates continue to ~~restrictions~~rise) ordue ~~withdrawals~~to ~~from~~supply chain constraints, consequences associated with COVID-19 and the ~~market~~ongoing conflict between Russia and weUkraine, ~~could~~employee ~~become~~availability ~~subject~~and wage increases, trade tariffs imposed on certain products from China and increased product pricing due to ~~penalties~~semiconductor product shortages.

~~☐ Even though we were successful in obtaining the sought~~Off-~~after~~Balance ~~FDA~~Sheet approvals, we may be unable to commercialize the Axim Eye System successfully in the United States. Successful commercialization will depend on a number of factors, including, among other things, achieving widespread acceptance of the Axim Eye System among physicians, establishing adequate sales and marketing capabilities, addressing competition effectively, the ability to obtain and enforce patents to protect proprietary rights from use by would-be competitors, key personnel retention and ensuring sufficient manufacturing capacity and inventory to support commercialization plans.Arrangements

~~Our~~We ~~business~~do isnot ~~subject~~have any off-balance sheet arrangements that have or are reasonably likely to ~~health~~have ~~care~~a ~~industry~~current ~~and~~or ~~government~~future ~~cost-containment~~effect ~~measures~~on ~~that~~our ~~could~~financial ~~result~~condition, changes in ~~reduced~~financial ~~sales~~condition, revenues or expenses, results of ~~our~~operations, ~~Axim~~liquidity, ~~Eye~~capital ~~System~~expenditures or capital resources that is material to investors.

WeGoing expect that most of our customers will rely on third-party payers, including government programs and private health insurance plans, to reimburse some or all of the cost of the procedures which use our Axim Eye System. The continuing efforts of governmental authorities, insurance companies, and other health care payers to contain or reduce these costs could lead to patients being unable to obtain approval for payment from these third-party payers. If patients cannot obtain third-party payer payment approval, the use of our Axim Eye System may decline significantly and our customers may reduce or eliminate the use of our system. The cost-containment measures that health care providers are instituting, both in the U.S. and internationally, could harm our ability to operate profitably. For example, managed care organizations successfully negotiate volume discounts for medical products, may choose not to reimburse certain products or reimburse products and a low amount sometimes below our selling price. This could result in lower prices to our customers from their customers and, in turn, reduce the amounts we can charge our customers for our products. Concern

InThe ~~addition~~Company’s tofinancial ~~general~~statements ~~health~~have ~~care~~been ~~industry~~presented ~~cost-containment,~~assuming that the ~~Centers~~Company ~~for~~will ~~Medicare~~continue ~~and~~as ~~Medicaid~~a ~~Services~~going ~~(“CMS”)~~concern. ~~released~~As ~~its~~shown ~~final~~in ~~rule~~the ~~implementing~~financial ~~section~~statements, ~~216(a) of~~ the ~~Protecting~~Company ~~Access~~has tonegative ~~Medicare~~working ~~Act~~capital of ~~2014~~$5,821,960 ~~(“PAMA”)~~has ~~that~~an ~~requires~~accumulated ~~reporting~~deficit ~~entities~~of to$72,184,858, ~~report~~has ~~private~~cash ~~payer~~used ~~rates~~in ~~paid~~operating toactivities ~~laboratories~~of ~~for tests~~$1,030,500 ~~which~~and ~~will~~presently bedoes ~~used~~not have the resources to ~~calculate~~accomplish ~~Medicare~~its ~~payment~~objectives ~~rates~~during the next twelve months. ~~Reporting~~These ~~entities,~~conditions ~~which~~raise ~~are~~substantial ~~primarily~~doubt ~~certain~~about ~~qualifying~~the ~~customers~~ability inof the ~~U.S.~~Company ~~that~~to ~~derive~~continue as a ~~certain~~going ~~percentage~~concern. ~~and~~The ~~volume~~financial ofstatements ~~their~~do ~~revenue~~not ~~from~~include ~~laboratory~~any ~~tests~~adjustments ~~from~~related ~~Medicare,~~to ~~report~~the ~~private~~recoverability ~~payer~~of ~~rates~~assets ~~for~~and ~~our~~classification ~~laboratory~~of ~~tests~~liabilities ~~which~~that ~~will~~might ~~serve~~be ~~under~~necessary should the ~~act~~Company asbe aunable ~~baseline~~to ~~for~~continue ~~future~~in ~~reimbursement~~operation.

IfThe weCompany ~~are~~may ~~subject~~not tobe ~~regulatory~~able ~~enforcement~~to ~~action~~meet asits acontractual ~~result~~obligations ofto ~~our~~Arizona ~~failure~~State toUniversity ~~comply~~regarding ~~with~~past ~~regulatory~~research; ~~requirements~~in addition, ~~our~~the ~~commercial~~Company ~~operations~~may ~~would~~not be ~~harmed~~able to maintain its staff at current levels.

~~Although~~The weCompany ~~have~~intends ~~received~~to ~~510(k)~~raise ~~clearance~~additional capital through private placements and/or ~~for~~registered ~~our~~offerings ~~Axim~~of ~~Eye~~debt ~~System~~and equity securities, webut ~~are~~there ~~subject~~can be no assurance that these funds will be available on terms acceptable to ~~significant~~the ~~ongoing~~Company ~~regulatory~~or ~~requirements~~will be sufficient to enable the Company to fully complete its development activities or sustain operations. If the Company is unable to raise sufficient additional funds, it will have to develop and ifimplement wea ~~fail~~plan to ~~comply~~further ~~with~~extend ~~these~~payables, ~~requirements~~reduce overhead, weor ~~could~~scale beback ~~subject~~its current business plan until sufficient additional capital is raised to ~~enforcement~~support ~~action~~further byoperations. ~~the~~There ~~FDA~~can orbe ~~state~~no ~~agencies,~~assurance ~~including:~~that such a plan will be successful.

☐ITEM adverse publicity, warning letters, fines, injunctions, consent decrees and civil penalties; ☐ repair, replacement, refunds, recall or seizure of our product; ☐ operating restrictions or partial suspension or total shutdown of production; ☐ delay or refusal of our requests for 510(k) clearance or premarket approval of new products or of new intended uses or modifications to our existing product; ☐ refusal to grant export approval for our products; ☐ withdrawing 510(k) clearances, CLIA waiver or premarket approvals that have already been granted; and ☐ criminal prosecution1C. CYBERSECURITY

31Risk ~~Table~~Assessment ofand ~~Contents~~Management

IfWe ~~the~~regularly ~~government~~assess ~~initiated~~risks ~~any~~from ofcybersecurity ~~these~~threats; ~~enforcement~~monitor ~~actions~~our information systems for potential vulnerabilities; and test those systems pursuant to our cybersecurity policies, processes, and practices, which are integrated into our ~~business~~overall ~~could~~risk bemanagement ~~harmed~~program. To protect our information systems from cybersecurity threats, we use various security tools that are designed to help identify, escalate, investigate, resolve, and recover from security incidents in a timely manner.

~~We are required to demonstrate and maintain compliance with the FDA’s Quality System Regulation, or the QSR.~~ The ~~QSR~~company ishas aan ~~complex~~ERM ~~regulatory~~program ~~scheme~~to ~~that covers the methods and documentation of the design~~identify, ~~testing~~evaluate, ~~control, manufacturing, labeling, quality assurance, packaging, storage~~ and ~~shipping~~manage ~~of our products~~risks. ~~The~~Cybersecurity ~~FDA~~risks ~~must determine that the facilities which manufacture and assemble our products that~~ are ~~intended~~evaluated ~~for~~alongside ~~sale~~other incritical ~~the~~business ~~United~~risks ~~States,~~under ~~as well as~~ the ~~manufacturing~~ERM ~~controls~~program ~~and~~to ~~specifications~~align ~~for~~cybersecurity ~~these~~efforts ~~products, are compliant~~ with ~~applicable regulatory requirements, including~~ the ~~QSR.~~company’s ~~The~~broader ~~FDA~~business ~~enforces~~goals ~~the~~and ~~QSR through periodic unannounced inspections~~objectives. ~~The~~We ~~FDA~~believe ~~has not yet inspected our facilities, and we cannot assure you~~ that weintegrating ~~will~~cybersecurity ~~pass~~risks ~~any~~into ~~future FDA inspection. Our failure, or the failure of~~ our ~~suppliers,~~ERM toprogram ~~take~~fosters ~~satisfactory~~a ~~corrective~~proactive ~~action~~and inholistic ~~response~~approach to ~~an adverse QSR inspection could result in enforcement actions~~cybersecurity, ~~including~~which ahelps ~~public~~safeguard ~~warning~~the ~~letter,~~company’s ~~a shutdown of our manufacturing~~ operations, afinancial ~~recall of our product~~condition, ~~civil or criminal penalties or other sanctions, which would significantly harm our available inventory~~ and ~~sales~~reputation ~~and~~in ~~cause~~an ~~our~~ever-evolving ~~business~~threat ~~to suffer~~landscape.

If24 weTable ~~are unable to fully comply with federal and state “fraud and abuse laws,” we could face substantial penalties, which may adversely affect our business, financial condition and results~~ of ~~operations.~~Contents

WeThe ~~are~~company ~~subject~~maintain toa ~~various~~cybersecurity ~~laws~~program ~~pertaining~~that tois ~~health~~designed ~~care~~to ~~fraud and abuse~~identify, ~~including~~protect ~~the U.S. Anti- Kickback Statute~~from, ~~physician self-referral laws (the “Stark Law”)~~detect, ~~the~~respond ~~U.S. False Claims Act, the U.S. False Statements Statute, the Physician Payment Sunshine Act, and state law equivalents~~ to ~~these U.S. federal laws~~, ~~which may not be limited to government-reimbursed items~~ and ~~may~~recover ~~not~~from ~~contain~~cybersecurity ~~identical~~threats ~~exceptions. Violations of these laws are punishable by criminal~~ and ~~civil sanctions~~risks, ~~including, in some instances, civil~~ and ~~criminal~~protect ~~penalties,~~the ~~damages~~confidentiality, ~~fines~~integrity, ~~exclusion from participation in U.S. federal~~ and ~~state~~availability ~~health~~of ~~care~~its ~~programs~~information systems, including ~~Medicare and Medicaid, and~~ the ~~curtailment~~information orresiding ~~restructuring~~on ofsuch ~~operations~~systems. ~~Any~~Keep ~~action~~in ~~against~~mind uswe ~~for~~are ~~violation of these laws could have~~ a ~~significant~~small ~~impact~~company onwith ~~our~~limited ~~business~~exposures. InAs ~~addition,~~such we ~~are~~rely ~~subject~~on totraditional ~~the~~bookkeeping ~~U.S.~~and ~~Foreign~~reconciliations ~~Corrupt~~to ~~Practices~~discover ~~Act.~~any ~~Any~~cybersecurity ~~action against us or our agents or distributors of this act could have a significant impact on our business~~issues.

Cybersecurity threats, including those resulting from any previous cybersecurity incidents, had not materially affected the company, including our business strategy, results of operations, or financial condition. We do not believe that cybersecurity threats resulting from any previous cybersecurity incidents of which we are aware are reasonably likely to materially affect our company. Our systems, infrastructure or data, or those used by our CROs, CMOs, clinical sites or other contractors or consultants, may ~~face~~or ~~future~~may ~~product~~be ~~liability~~perceived ~~claims~~to fail or suffer a cyberattack, security breach or other incident, including a breakdown or compromise of the confidentiality, integrity and availability of our systems, networks or data, which could adversely affect the operation of our business and reputation.

~~The~~Incident testing, manufacturing, marketing and sale of therapeutic and diagnostic products entail significant inherent risks of allegations of product liability. Our use of the Axim Eye System and/or any of our products that are currently in development and commercial sale thereof could also expose us to liability claims. All of such claims might be made directly by patients, health care providers or others selling our products. We plan to purchase product liability insurance to cover certain claims that could arise during the commercial use of our products. Any coverage obtained in the future, may be inadequate to protect us in the event of successful product liability claims, and we may not increase the amount of such insurance coverage or even renew it. A successful product liability claim could materially harm our business. In addition, substantial, complex or extended litigation could result in the incurrence of large expenditures and the diversion of significant resources.Response

IfThe wecompany dodoes not ~~introduce~~have ~~new~~a ~~commercially~~dedicated ~~successful~~incident ~~products~~management inteam aresponsible ~~timely~~for ~~manner,~~managing ~~our~~and ~~products~~coordinating ~~may~~its ~~become~~cybersecurity ~~obsolete~~incident ~~over~~response ~~time,~~efforts. ~~customers~~We ~~may~~have ~~not~~limited ~~buy~~exposure ~~our~~to ~~products~~cybersecurity ~~and~~risks. We ~~our~~are ~~revenue~~a ~~and~~small ~~profitability may decline~~company.

~~Demand for our products may change in ways we may not anticipate because of:~~Governance

☐Board ~~evolving~~Oversight ~~customer needs; ☐ the introduction of new products and technologies; and ☐ evolving industry standards.~~Role

32Our ~~Table~~Board of ~~Contents~~Directors oversees our risk management process, including as it pertains to cybersecurity risks, directly and through its committees. The Audit Committee (the Committee) of the Board of Directors oversees our cybersecurity and data privacy. The Committee meets periodically to review and discuss with management risks relating to significant cybersecurity matters and concerns involving the company, including information security, data privacy, backup of information systems and related regulatory matters and compliance. The Committee regularly reports to the Board of Directors with respect to the Committee’s activities and recommendations, including those relating to cybersecurity matters and concerns. The company provides reports to the Committee on information security matters, including the adequacy and effectiveness of the company’s information security policies and practices and the internal controls regarding information security, and notifies the chairperson of the Committee as soon as practicable of significant information security matters and concerns as they arise on a periodic basis.

~~Without~~Management’s the timely introduction of new commercially successful products and enhancements, our products may become obsolete over time, in which case our sales and operating results would suffer. The success of our new product offerings will depend on several factors, including our ability to:Role

☐The ~~properly~~company ~~identify~~does ~~and~~not ~~anticipate~~have ~~customer needs; ☐ commercialize new products in~~ a ~~cost-effective~~dedicated ~~and~~cybersecurity ~~timely~~organization ~~manner;~~within ☐its ~~manufacture~~technology ~~and~~department ~~deliver~~that ~~products~~focuses ~~in sufficient volumes~~ on ~~time;~~current ~~☐ obtain~~ and ~~maintain~~emerging ~~regulatory~~cybersecurity approval for such new products; ☐ differentiate our offerings from competitors’ offerings; ☐ achieve positive clinical outcomes; and ☐ provide adequate medical and/or consumer education relating to new productsmatters.

~~Moreover,~~Use ~~innovations generally will require a substantial investment in research and development before we can determine the commercial viability~~ of ~~these~~Third innovations and we may not have the financial resources necessary to fund these innovations. In addition, even if we successfully develop enhancements or new generations of our products, these enhancements or new generations of products may not produce revenue in excess of the costs of development and they may be quickly rendered obsolete by changing customer preferences or the introduction by our competitors of products embodying new technologies or features.Parties

WeOversight ~~rely on a limited number~~ of ~~suppliers~~Third-Party ofService ~~each of the key components of the Axim Eye System and are vulnerable to fluctuations in the availability and price of our suppliers’ products and services.~~Providers

WeThe ~~purchase~~company ~~each~~uses ~~of the key components of the Axim Eye System from a limited number of~~ third-party ~~suppliers.~~service ~~Our~~providers ~~suppliers~~to ~~may~~support ~~not~~its ~~provide~~operations ~~the~~and ~~components~~many orof ~~other~~its ~~products~~technology ~~needed~~initiatives, byand usevaluates inits ~~the~~third-party ~~quantities~~service ~~requested,~~providers infrom a ~~timely~~cybersecurity ~~manner~~risk orperspective, atwhich amay ~~price~~include wean ~~are~~assessment ~~willing to pay. This is~~ of ~~particular concern currently due to global supply chain and inflationary pressures~~ that ~~companies~~service inprovider’s ~~our~~cybersecurity ~~fields~~posture ~~have recently faced. In the event we are unable to renew our agreements with our suppliers~~ or ~~they~~a ~~become~~recommendation ~~unable~~of orspecific ~~unwilling~~mitigation tocontrols. ~~continue~~Following tosuch ~~provide~~evaluation, ~~important components in~~ the ~~required~~company ~~volumes~~determines and ~~quality~~prioritizes ~~levels~~service orprovider inrisk abased ~~timely~~on ~~and cost effective manner, or if regulations affecting~~ the ~~components~~potential ~~change,~~threat weimpact ~~may be required to identify~~ and ~~obtain acceptable replacement supply sources. We may not be able to obtain alternative suppliers or vendors on a timely basis~~likelihood, orand atsuch ~~all,~~risk ~~which~~determination ~~could~~drives ~~disrupt or delay, or halt altogether, our ability to manufacture or deliver~~ the ~~Axim~~level ~~Eye System or our other products currently in development. If any~~ of ~~these~~due ~~events~~diligence ~~should occur, our business, financial condition, cash flows~~ and ~~results~~ongoing ofcompliance ~~operations~~monitoring ~~could~~required befor ~~materially~~each ~~adversely~~service ~~affected~~provider.

We25 ~~face~~Table ~~intense competition, and our failure to compete effectively could have a material adverse effect on our results~~ of ~~operations.~~Contents

WePART face intense competition in the markets for ophthalmic products and these markets are subject to rapid and significant technological change. We have numerous potential competitors in the United States and abroad. We face potential competition from industry participants marketing conventional technologies for the measurement of dye eye and other in-lab-testing technologies, and commercially available methods, such as the Schirmer Test and ocular surface staining. Many of our potential competitors have substantially more resources and a greater marketing scale than we do. If we are unable to develop and produce or market our products to effectively compete against our competitors, our operating results will materially suffer.II

WeItem ~~are~~5. ~~heavily~~Market ~~dependent~~for onRegistrant’s ~~the~~Common ~~success~~Equity ~~of our technologies~~ and ~~product~~Related ~~candidates,~~Stockholder Matters and weIssuer ~~cannot~~Purchases ~~give any assurance that certain~~ of ~~our~~Equity product candidates will receive regulatory approval, which is necessary before such products can be commercialized, or that we will be able to successfully commercialize those products that we have secured regulatory approval for or do not need further regulatory approval for. Securities

ToOur ~~date,~~common westock ~~have~~is ~~invested~~currently atraded ~~significant~~on ~~portion of our efforts and financial resources in~~ the ~~acquisition~~OTCQB ~~and~~under ~~development~~trading ofsymbol ~~our product candidates~~“AXIM.” AsAn anactive ~~early~~public ~~stage~~market ~~biotechnology~~for ~~company~~our ~~that~~common ~~has~~stock ~~recently~~may ~~made significant changes to its operations, we have limited experience and have~~ not ~~yet~~develop ~~demonstrated~~or anbe ~~ability~~sustained. toTrading ~~successfully overcome many~~ of ~~the~~securities ~~risks~~on ~~and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in~~ the ~~biopharmaceutical~~OTCQB ~~area. Our future success~~ is ~~substantially~~often ~~dependent~~sporadic onand ~~our~~investors ~~ability~~may tohave ~~successfully~~difficulty ~~develop,~~buying ~~obtain regulatory approval for (to the extent required),~~ and ~~then~~selling ~~successfully~~or ~~commercialize~~obtaining ~~our~~market ~~product candidates~~quotations. ~~Although~~Any weOTCQB ~~have~~market ~~secured~~quotations ~~FDA~~reflect ~~approval~~inter-dealer ~~of our Axim Eye System~~quotations, ~~many~~without ofadjustment ~~our~~for ~~product~~retail ~~candidates~~mark-up, ~~are~~mark-down ~~currently in preclinical development~~ or incommission ~~clinical trials. Our business depends entirely on the successful development~~ and ~~commercialization~~may ofnot ~~our~~necessarily ~~product~~represent ~~candidates,~~actual ~~which may never occur~~transactions.

33The ~~Table~~following oftable ~~Contents~~sets forth the high and low closing bid prices for our common stock as reported on OTCQB for the following periods. These prices do not include retail mark-ups, markdowns or commissions, and may not necessarily represent actual transactions.

The successful development, and any commercialization, of our technologies and any product candidates would require us to successfully perform a variety of functions, including:

	High ($)		Low ($)
Fiscal Year Ended December 31, 2023
First Quarter		0.043		0.017
Second Quarter		.049		0.02
Third Quarter		0.036		0.019
Fourth Quarter		0.024		0.016

Fiscal Year Ended December 31, 2022
First Quarter		0.399		0.125
Second Quarter		0.13		0.056
Third Quarter		0.107		0.04
Fourth Quarter		0.104		0.027

☐As ~~seeking~~of ~~and~~April ~~obtaining~~12, ~~intellectual~~2024, ~~property~~there ~~and/or~~are ~~proprietary~~156 ~~rights~~holders toof record of our ~~technology~~common ~~and/or~~stock. ~~the~~This ~~technology~~number ofdoes ~~others;~~not ☐include ~~identifying,~~beneficial ~~developing,~~holders ~~manufacturing~~of ~~and~~our ~~commercializing~~common ~~product~~stock. ~~candidates;~~Because ☐many ~~entering~~of ~~into~~our ~~successful~~shares ~~licensing~~of ~~and~~common ~~other~~stock ~~arrangements~~are ~~with~~held ~~product~~by ~~development~~brokers ~~partners;~~and ☐other ~~participating~~institutions inon ~~regulatory~~behalf ~~approval~~of ~~processes~~shareholders, towe ~~the~~are ~~extent~~unable ~~required;~~to ☐estimate ~~formulating~~the ~~and~~total ~~manufacturing~~number ~~products;~~of ~~and~~shareholders ☐represented ~~conducting~~by ~~sales~~these ~~and~~record ~~marketing activities~~holders.

Certain of our product candidates will require additional preclinical or clinical development; management of preclinical, clinical and manufacturing activities; regulatory approval in multiple jurisdictions; obtaining manufacturing supply; building of a commercial organization; and significant marketing efforts before we generate any revenues from product sales. We are not permitted to market or promote any of our product candidates before we receive regulatory approval from the FDA, or comparable foreign regulatory authorities, and we may never receive such regulatory approval for such product candidates. In addition, certain of our product development programs contemplate the development of companion diagnostics. Companion diagnostics are subject to regulation as medical devices and must themselves be approved for marketing by the FDA, or certain other foreign regulatory agencies before we may commercialize our product candidates.Dividends

IfWe wehave ~~fail~~never todeclared ~~comply~~or ~~with~~paid ~~manufacturing~~cash ~~regulations,~~dividends on our ~~financial~~common ~~results~~stock. ~~and~~We ~~financial~~anticipate ~~condition~~that in the future we will beretain ~~adversely~~any ~~affected~~earnings for operation of our business. Accordingly, we do not anticipate declaring or paying any cash dividends in the foreseeable future.

WeSecurities ~~currently~~Authorized ~~manufacture~~for ~~some~~Issuance ofUnder ~~our~~Equity ~~materials~~Compensation in-house. In addition, we may enter into collaboration and license agreements with certain collaborators, pursuant to which we may, among other things, agree to carry out manufacturing of our collaborators’ material and product candidates. However, we only recently began manufacturing such materials and do not have significant prior experience manufacturing preclinical or product candidates. Before we can begin commercial manufacture of our or any potential collaborators’ materials or product candidates, regulatory authorities must approve marketing applications that identify manufacturing facilities operated by us or our contract manufacturers that have passed regulatory inspection and manufacturing processes that are acceptable to the regulatory authorities. Plans

~~Due~~The tocompany ~~the~~adopted ~~complexity~~its of2015 ~~the~~Stock ~~processes~~Incentive ~~used~~Plan, toeffective ~~manufacture~~May ~~our~~29, ~~product candidates and our potential collaborators’ product candidates~~2015, weunder ~~may~~which beeligible ~~unable~~persons ~~to continue to pass~~ or ~~initially~~vendors ~~pass~~whom ~~federal~~provide ~~or international regulatory inspections in a cost-effective manner. For~~ the ~~same~~company ~~reason,~~services ~~any potential third-party manufacturer of our product candidates~~ may be ~~unable~~afforded an opportunity to ~~comply~~acquire ~~with~~an ~~cGMP~~equity ~~regulations~~interest in athe ~~cost-effective~~company ~~manner~~in ~~and~~exchange ~~may~~for bethose ~~unable~~services toprovided. ~~initially~~The or2015 ~~continue~~Stock toIncentive ~~pass~~Plan awas ~~federal~~amended oreffective ~~international~~December ~~regulatory~~24, ~~inspection~~2021.

IfThe ~~we,~~following ortable ~~third-party~~provides ~~manufacturers~~information ~~with~~as ~~whom we contract, are unable to comply with manufacturing regulations, we may be subject to delay~~ of ~~approval~~December ~~of our product candidates~~31, ~~warning or untitled letters~~2023, ~~fines,~~regarding ~~unanticipated compliance expenses, recall or seizure of~~ our ~~products,~~equity ~~total~~compensation or partial suspension of production and/or enforcement actions, including injunctions, and criminal or civil prosecution. These possible sanctions would adversely affect our financial results and financial condition.plans:

The manufacture of pharmaceutical products requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. Manufacturers of pharmaceutical products often encounter difficulties in production, which include difficulties with production costs and yields, quality control and assurance and shortages of qualified personnel, as well as compliance with strictly enforced federal, state and foreign regulations. The third-party manufacturers we may contract with may not perform as agreed or may terminate their agreements with us. Any of these factors could cause us to delay or suspend any future clinical trials, regulatory submissions, required approvals or commercialization of one or more of our drug candidates, entail higher costs and result in our being unable to effectively commercialize products.

Plan Category	Number of securities to be issued upon exercise of outstanding options, warrants and rights		Weighted-average exercise price of outstanding options, warrants and rights		Number of securities remaining available for future issuance under equity compensation plans
Equity compensation plans approved by security holders		27,662,576	$	0.13		25,881,671
Equity compensation plans not approved by security holders		–		–		–
Total		27,662,576	$	0.13		25,881,671

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~~Material~~Unregistered ~~necessary~~Sales toof ~~manufacture~~Equity ~~product~~Securities ~~candidates may not be available on commercially reasonable terms, or at all, which may delay the development~~ and ~~commercialization~~Use of ~~product candidates.~~ Proceeds

~~There~~The ~~are~~Company adid ~~limited~~not ~~number~~sell ofany ~~suppliers~~securities ~~for raw materials~~ that wewere ~~use~~not toregistered ~~manufacture~~under ~~our~~the ~~products~~Securities ~~and~~Act ~~product candidates and there may be a need to assess alternate suppliers to prevent a possible disruption~~ of ~~the manufacture of the materials necessary to produce our product candidates for clinical trials~~1933, ~~and~~as ~~if approved~~amended, ~~ultimately~~during ~~for~~fiscal ~~commercial~~year ~~sale.~~2022 Wethat ~~do not~~ have ~~any control over the process or timing of the acquisition of these raw materials by us. We typically do~~ not ~~have~~already ~~any~~been ~~agreements~~reported ~~for~~on ~~the commercial production of these raw materials. Any significant delay in the supply of~~ a ~~product~~Current ~~candidate,~~Report oron ~~the~~Form ~~raw material components thereof, for an ongoing clinical trial due to the need to obtain or replace a third~~8-~~party~~K manufacturer could considerably delay completion of our clinical trials, product testing and potential regulatory approval of our product candidates. If we are unable to purchase these raw materials after regulatory approval has been obtained for our product candidates, the commercial launch of our product candidates would be delayed or ~~there would be~~ a ~~shortage~~Quarterly inReport ~~supply,~~on ~~which~~Form ~~would impair our ability to generate revenues from the sale of our product candidates~~10-Q.

WeDuring ~~may~~the ~~not~~year beended ~~able~~December to31, ~~manufacture~~2023, ~~our~~the ~~products~~Company orentered ~~product~~into ~~candidates~~a Stock Purchase agreement whereby shares were issued in ~~commercial~~exchange ~~quantities~~for the purchase of equipment. 7,280,000 ~~which~~shares ~~would~~were ~~prevent~~issued usat ~~from~~.01 ~~commercializing~~per ~~our~~share ~~products~~resulting ~~and~~in ~~product~~a ~~candidates~~loss at issuance of $80,080.

WeIssuer ~~are~~Repurchases largely dependent on our third-party manufacturers to conduct process development and scale-up work necessary to support greater clinical development and commercialization requirements for our products and product candidates. Carrying out these activities in a timely manner, and on commercially reasonable terms, is critical to the successful development and commercialization of ~~our~~Equity ~~products~~Securities and product candidates. We expect our third-party manufacturers are capable of providing sufficient quantities of our products and product candidates to meet anticipated clinical and full-scale commercial demands; however, if third parties with whom we currently work are unable to meet our supply requirements, we will need to secure alternate suppliers or face potential delays or shortages. While we believe that there are other contract manufacturers with the technical capabilities to manufacture our products and product candidates, we cannot be certain that identifying and establishing relationships with such sources would not result in significant delay or material additional costs.

~~If we are unable to successfully commercialize our products, our business, financial condition and results of operations will be materially and adversely affected~~None.

We are currently building our sales and marketing organization. We currently anticipate that, we may rely on third parties to sell our product candidates in the U.S. and/or in international markets. If we enter into arrangements with third parties to sell and market our products, we would likely receive less revenue than if we sold our products directly. In addition, although we would intend to use due diligence in monitoring the activities of our third-party sales and marketing partners, we may have little or no control over the sales efforts of those third parties. In the event we are unable to develop our own sales force or collaborate with third parties to sell our product candidates, we may not be able to successfully commercialize our product candidates, which would negatively impact our ability to generate revenue. In the event that we elect to market our own products, we will also have to compete with other pharmaceutical and biotechnology companies to recruit, hire and train sales and marketing personnel.

Our failure to successfully discover, acquire, develop and market additional product candidates or approved products would impair our ability to grow.

As part of our growth strategy, we intend to develop and market additional products and product candidates. We are pursuing various therapeutic opportunities through our product pipeline. We may spend several years completing our development of any particular current or future internal product candidate, and failure can occur at any stage. The product candidates to which we allocate our resources may not end up being successful. In addition, because our internal research capabilities are limited, we may be dependent upon pharmaceutical and biotechnology companies, academic scientists and other researchers to sell or license products or technology to us. The success of this strategy depends partly upon our ability to identify, select, discover and acquire promising pharmaceutical product candidates and products. Failure of this strategy would impair our ability to grow.

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The process of proposing, negotiating and implementing a license or acquisition of a product candidate or approved product is lengthy and complex. Other companies, including some with substantially greater financial, marketing and sales resources, may compete with us for the license or acquisition of product candidates and approved products. We have limited resources to identify and execute the acquisition or in-licensing of third-party products, businesses and technologies and integrate them into our current infrastructure. Moreover, we may devote resources to potential acquisitions or in-licensing opportunities that are never completed, or we may fail to realize the anticipated benefits of such efforts. We may not be able to acquire the rights to additional product candidates on terms that we find acceptable, or at all.

In addition, future acquisitions may entail numerous operational and financial risks, including:

☐ disruption of our business and diversion of our management’s time and attention to develop acquired products or technologies; ☐ incurrence of substantial debt, dilutive issuances of securities or depletion of cash to pay for acquisitions; ☐ higher than expected acquisition and integration costs; ☐ difficulty in combining the operations and personnel of any acquired businesses with our operations and personnel; ☐ increased amortization expenses; ☐ impairment of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership; ☐ impairment of our ability to obtain intellectual property rights or rights to commercialize additional product candidates, or increased cost to obtain such rights; ☐ inability to motivate key employees of any acquired businesses; and ☐ assumption of known and unknown liabilities.

Further, any product candidate that we acquire may require additional development efforts prior to commercial sale, including extensive clinical testing and approval by the FDA and applicable foreign regulatory authorities. All product candidates are prone to risks of failure typical of pharmaceutical product development, including the possibility that a product candidate will not be shown to be sufficiently safe and effective for approval by regulatory authorities.

Healthcare reform measures could hinder or prevent our product candidates’ commercial success.

In both the U.S. and certain foreign jurisdictions, there have been, and we expect there will continue to be, a number of legislative and regulatory changes to the health care system that could impact our ability to sell our products profitably. The U.S. government and other governments have shown significant interest in pursuing healthcare reform. In particular, the Medicare Modernization Act of 2003 revised the payment methodology for many products under the Medicare program in the U.S. This has resulted in lower rates of reimbursement. In 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the “Healthcare Reform Law”), was enacted. The Healthcare Reform Law substantially changed the way healthcare is financed by both governmental and private insurers. Such government-adopted reform measures may adversely impact the pricing of healthcare products and services in the U.S. or internationally and the amount of reimbursement available from governmental agencies or other third-party payors.

There have been, and likely will continue to be, legislative and regulatory proposals at the federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. For example, there have been public announcements by members of the U.S. Congress regarding their plans to repeal and replace the Healthcare Reform Law and Medicare, and the Biden administration has announced plans to amend and expand the scope of the Healthcare Reform Law. Although we cannot predict the ultimate content or timing of any healthcare reform legislation, potential changes resulting from any amendment, repeal, replacement or expansion of these programs, including any reduction in the future availability of healthcare insurance benefits, could adversely affect our business and future results of operations. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare may adversely affect the demand for any product candidates for which we may obtain regulatory approval, as well as our ability to set satisfactory prices for our products, to generate revenues, and to achieve and maintain profitability.

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Failure to successfully validate, develop and obtain regulatory approval for companion diagnostics could harm our long-term development strategy.

As one of the key elements of our clinical development strategy, we seek to identify patients within a disease category or indication who may derive selective and meaningful benefit from the product candidates we are developing. As such, we plan to develop, or partner with third parties to develop, companion diagnostics to help us to more accurately identify patients within a particular category or indication, both during our clinical trials and in connection with the commercialization of certain of our product candidates.

Companion diagnostics are subject to regulation by the FDA and comparable foreign regulatory authorities as medical devices and require separate regulatory approval prior to commercialization. We and our collaborators may encounter difficulties in developing and obtaining approval for the companion diagnostics, including issues relating to selectivity/specificity, analytical validation, reproducibility or clinical validation. Any delay or failure by our collaborators to develop or obtain regulatory approval of the companion diagnostics could delay or prevent approval of our product candidates. In addition, our collaborators may encounter production difficulties that could constrain the supply of the companion diagnostics, and both they and we may have difficulties gaining acceptance of the use of the companion diagnostics in the clinical community. If such companion diagnostics fail to gain market acceptance, it would have an adverse effect on our ability to derive revenues from sales of our products. In addition, any diagnostic company with whom we contract may decide to discontinue selling or manufacturing the companion diagnostic that we anticipate using in connection with development and commercialization of our product candidates or our relationship with such diagnostic company may otherwise terminate. In such instances, we may not be able to enter into arrangements with another diagnostic company to obtain supplies of an alternative diagnostic test for use in connection with the development and commercialization of our product candidates or do so on commercially reasonable terms, which could adversely affect and/or delay the development or commercialization of our product candidates.

We may seek to establish collaborations and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.

From time to time we may engage in efforts to enter into licensing, distribution and/or collaboration agreements with one or more pharmaceutical or biotechnology companies to assist us with development and/or commercialization of our other product candidates. If we are successful in entering into such agreements, we may not be able to negotiate agreements with economic terms similar to those negotiated by other companies. We may not, for example, obtain significant upfront payments, substantial royalty rates or milestones. If we fail to enter into any such agreements in a timely manner or at all, our efforts to develop and/or commercialize our product candidates may be undermined. In addition, if we do not raise funds through any such agreements, we will need to rely on other financing mechanisms, such as sales of debt or equity securities, to fund our operations. Such financing mechanisms, if available, may not be sufficient or timely enough to advance our programs forward in a meaningful way in the short-term.

We may not be successful in entering into additional collaborations as a result of many factors, including the following:

☐ competition in seeking appropriate collaborators; ☐ a reduced number of potential collaborators due to recent business combinations in the pharmaceutical industry; ☐ inability to negotiate collaborations on acceptable terms; ☐ inability to negotiate collaborations on a timely basis; ☐ a potential collaborator’s evaluation of our product or product candidates; ☐ a potential collaborator’s resources and expertise; and ☐ restrictions due to an existing collaboration agreement.

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If we are unable to enter into collaborations, we may have to curtail the commercialization or the development of any product candidate on which we are seeking to collaborate, reduce or delay its development program or those for other of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense. If we elect to increase our expenditures to fund development or commercialization activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms or at all. If we do not have sufficient funds, we may not be able to develop or commercialize our product candidates.

Even if we enter into collaboration agreements and strategic partnerships or license our intellectual property, we may not be able to maintain them or they may be unsuccessful, which could delay our timelines or otherwise adversely affect our business.

We, as well as any collaborators or licensees of our technologies and services, will not be able to commercialize our product candidates if preclinical studies do not produce successful results or clinical trials do not demonstrate safety and efficacy in humans.

Preclinical and clinical testing is expensive, difficult to design and implement, can take many years to complete and have an uncertain outcome. Success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful, and interim results of a clinical trial do not necessarily predict final results. We, as well as any licensees and collaborators, may experience numerous unforeseen events during, or as a result of, preclinical testing and the clinical trial process that could delay or prevent the commercialization of product candidates based on our technologies, including the following:

☐ Preclinical or clinical trials may produce negative or inconclusive results, which may require additional preclinical testing, additional clinical trials or the abandonment of projects that we, our licensees or our collaborators expect to be promising. For example, promising animal data may be obtained about the anticipated efficacy of a product candidate and then human tests may not result in such an effect. In addition, unexpected safety concerns may be encountered that would require further testing even if the product candidate produced an otherwise favorable response in human subjects. ☐ Initial clinical results may not be supported by further or more extensive clinical trials. For example, we or a licensee may obtain data that suggest a desirable response from a product candidate in a small human study, but when tests are conducted on larger numbers of people, the same extent of response may not occur. If the response generated by a product candidate is too low or occurs in too few treated individuals, then the product candidate will have no commercial value. ☐ Enrollment in any of our or any of our licensees’ or collaborators’ clinical trials may be slower than projected, resulting in significant delays. The cost of conducting a clinical trial increases as the time required to enroll adequate numbers of human subjects to obtain meaningful results increases. Enrollment in a clinical trial can be a slower-than-anticipated process because of competition from other clinical trials, because the study is not of interest to qualified subjects, or because the stringency of requirements for enrollment limits the number of people who are eligible to participate in the clinical trial. ☐ We, our licensees or our collaborators might have to suspend or terminate clinical trials if the participating subjects are being exposed to unacceptable health risks. Animal tests do not always adequately predict potential safety risks to human subjects. The risk of any product candidate is unknown until it is tested in human subjects, and if subjects experience adverse events during the clinical trial, the trial may have to be suspended and modified or terminated entirely. ☐ Regulators or institutional review boards may suspend or terminate clinical research for various reasons, including safety concerns or noncompliance with regulatory requirements. ☐ Any regulatory approval ultimately obtained may be limited or subject to restrictions or post-approval commitments that render the product not commercially viable. ☐ The effects of our technology-derived or technology-enhanced product candidates may not be the desired effects or may include undesirable side effects.

Significant clinical trial delays could allow our competitors to bring products to market before we, any of our licensees or our collaborators do and impair our ability to commercialize our technologies and product candidates based on our technologies. Poor clinical trial results or delays may make it impossible to license a product candidate or so reduce its attractiveness to prospective licensees that we will be unable to successfully develop and commercialize such a product candidate.

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Because our development activities are expected to rely heavily on sensitive and personal information, an area which is highly regulated by privacy laws, we may not be able to generate, maintain or access essential patient samples or data to continue our research and development efforts in the future on reasonable terms and conditions, which may adversely affect our business.

Although we are not subject to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as we are neither a Covered Entity nor Business Associate (as defined in HIPAA and the Health Information Technology and Clinical Health Act (the “HITECH Act”), we may have access to very sensitive data regarding patients whose tissue samples are used in our studies. This data will contain information that is personal in nature. The maintenance of this data is subject to certain privacy-related laws, which impose upon us administrative and financial burdens, and litigation risks. In the U.S., numerous federal and state laws and regulations, including state data breach notification laws, state health information privacy laws and federal and state consumer protection laws govern the collection, use, disclosure and protection of health-related and other personal information. For instance, the rules promulgated by the Department of Health and Human Services under HIPAA create national standards to protect patients’ medical records and other personal information in the U.S. These rules require that healthcare providers and other covered entities obtain written authorizations from patients prior to disclosing protected health care information of the patient to companies. If the patient fails to execute an authorization or the authorization fails to contain all required provisions, then we will not be allowed access to the patient’s information and our research efforts can be substantially delayed. Furthermore, use of protected health information that is provided to us pursuant to a valid patient authorization is subject to the limits set forth in the authorization (i.e., for use in research and in submissions to regulatory authorities for product approvals). As such, we are required to implement policies, procedures and reasonable and appropriate security measures to protect individually identifiable health information we receive from covered entities, and to ensure such information is used only as authorized by the patient. Any violations of these rules by us could subject us to civil and criminal penalties and adverse publicity and could harm our ability to initiate and complete clinical trials required to support regulatory applications for our product candidates. In addition, HIPAA does not replace federal, state, or other laws that may grant individuals even greater privacy protections.

California recently enacted the California Consumer Privacy Act (“CCPA”), which creates new individual privacy rights for California consumers and places increased privacy and security obligations on entities handling personal data of consumers or households. The CCPA requires covered companies to provide new disclosure to consumers about such companies’ data collection, use and sharing practices, provide such consumers new ways to opt-out of certain sales or transfers of personal information, and provide consumers with additional causes of action. The CCPA went into effect on January 1, 2020, and beginning July 1, 2020, the California Attorney General may bring enforcement actions for violations. The CCPA, among other things, requires covered companies to provide disclosures to California consumers concerning the collection and sale of personal information, and will give such consumers the right to opt-out of certain sales of personal information. The CCPA may increase our company's compliance costs and potential liability, and we cannot yet predict the impact of the CCPA on our business.

International data protection laws, including Regulation 2016/679, known as the General Data Protection Regulation (“GDPR”), may also apply to health-related and other personal information obtained outside of the United States. The GDPR went into effect on May 25, 2018. The GDPR strengthened data protection requirements in the European Union, as well as potential fines for noncompliant companies of up to the greater of €20 million or 4% of annual global revenue. The regulation imposes numerous new requirements for the collection, use, storage and disclosure of personal information, including more stringent requirements relating to consent and the information that must be shared with data subjects about how their personal information is used, the obligation to notify regulators and affected individuals of personal data breaches, extensive new internal privacy governance obligations and obligations to honor expanded rights of individuals in relation to their personal information, including the right to access, correct and delete their data. In addition, the GDPR includes restrictions on cross-border data transfers. The GDPR increased our responsibility and liability in relation to personal data that we process where such processing is subject to the GDPR, and we may be required to put in place additional mechanisms to ensure compliance with the GDPR, including as implemented by individual countries. Further, the United Kingdom’s exit from the European Union, often referred to as Brexit, has created uncertainty with regard to data protection regulation in the United Kingdom. In particular, it is unclear how data transfers to and from the United Kingdom will be regulated.

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Failure to comply with data protection laws and regulations could result in government enforcement actions, which may involve civil and criminal penalties, private litigation and/or adverse publicity and could negatively affect our operating results and business. Claims that we have violated individuals’ privacy rights or breached our contractual obligations, even if we are not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm our business.

We can provide no assurance that future legislation will not prevent us from generating or maintaining personal data or that patients will consent to the use of their personal information, either of which may prevent us from undertaking or publishing essential research. These burdens or risks may prove too great for us to reasonably bear and may adversely affect our ability to achieve profitability or maintain profitably in the future.

We may be exposed to liability claims associated with the use of hazardous materials and chemicals.

Our research and development activities may involve the controlled use of hazardous materials and chemicals. Although we believe that our safety procedures for using, storing, handling and disposing of these materials comply with federal, state and local laws and regulations, we cannot eliminate the risk of accidental injury or contamination from these materials. In the event of such an accident, we could be held liable for any resulting damages and any liability could materially adversely affect our business, financial condition and results of operations. We do not currently maintain hazardous materials insurance coverage. In addition, the federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of hazardous or radioactive materials and waste products may require us to incur substantial compliance costs that could materially harm our business.

If we are unable to retain and recruit qualified scientists and advisors, or if any of our key executives, key employees or key consultants discontinues his or her employment or consulting relationship with us, it may delay our development efforts or otherwise harm our business.

We may not be able to attract or retain qualified management and scientific and clinical personnel in the future due to the intense competition for qualified personnel among biotechnology, pharmaceutical and other businesses, particularly in the San Diego, California area. Our industry has experienced a high rate of turnover of management personnel in recent years. If we are not able to attract, retain and motivate necessary personnel to accomplish our business objectives, we may experience constraints that will significantly impede the successful development of any product candidates, our ability to raise additional capital and our ability to implement our overall business strategy. In addition, our CMO operations will depend, in part, on our ability to attract and retain an appropriately skilled and sufficient workforce to operate our development and manufacturing facilities. The facilities are located in a growing biotechnology hub and competition for skilled workers will continue to increase as the industry undergoes further growth in the area.

We are highly dependent on key members of our management and scientific staff, especially John W. Huemoeller II., Chairman of the Board, Chief Executive Officer and President, Catalina Valencia, Sapphire’s Chief Executive Officer, and Sergei Svarovsky, our Chief Science Officer. Our success also depends on our ability to continue to attract, retain and motivate highly skilled junior, mid-level and senior managers as well as junior, mid-level and senior scientific and medical personnel. The loss of any of our executive officers, key employees or key consultants and our inability to find suitable replacements could impede the achievement of our research and development objectives, and potentially harm our business, financial condition and prospects. Furthermore, recruiting and retaining qualified scientific personnel to perform research and development work in the future is critical to our success. We may be unable to attract and retain personnel on acceptable terms given the competition among biotechnology, biopharmaceutical and health care companies, universities and non-profit research institutions for experienced scientists. Certain of our current officers, directors, scientific advisors and/or consultants or certain of the officers, directors, scientific advisors and/or consultants hereafter appointed may from time to time serve as officers, directors, scientific advisors and/or consultants of other biopharmaceutical or biotechnology companies. We do not maintain “key man” insurance policies on any of our officers or employees. All of our employees are employed “at will” and, therefore, each employee may leave our employment at any time.

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We may not be able to attract or retain qualified management and scientific personnel in the future due to the intense competition for a limited number of qualified personnel among biopharmaceutical, biotechnology, pharmaceutical and other businesses. Many of the other pharmaceutical companies that we compete against for qualified personnel have greater financial and other resources, different risk profiles and a longer history in the industry than we do. They also may provide more diverse opportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than what we have to offer. If we are unable to continue to attract and retain high quality personnel, the rate and success at which we can develop and commercialize product candidates will be limited.

We plan to grant stock options or other forms of equity awards in the future as a method of attracting and retaining employees, motivating performance and aligning the interests of employees with those of our stockholders. If we are unable to implement and maintain equity compensation arrangements that provide sufficient incentives, we may be unable to retain our existing employees and attract additional qualified candidates. If we are unable to retain our existing employees, including qualified scientific personnel, and attract additional qualified candidates, our business and results of operations could be adversely affected.

Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.

We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional failures to comply with FDA regulations, provide accurate information to the FDA, comply with manufacturing standards we have established, comply with federal and state health-care fraud and abuse laws and regulations, comply with laws and regulations (including, but not limited to the Foreign Corrupt Practices Act of 1977, as amended, 15 U.S.C. §§ 78dd-1 (“FCPA”)) and internal policies restricting payments to government agencies and representatives, report financial information or data accurately or disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. We have adopted a Code of Business Conduct and Ethics, but it is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations, including the imposition of significant fines or other sanctions.

We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

If we obtain FDA approval for any of our product candidates and begin commercializing those products in the U.S., our operations may be directly, or indirectly through our customers, subject to various federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute and the federal False Claims Act. These laws may impact, among other things, our proposed sales, marketing and education programs. In addition, we may be subject to patient privacy regulation by both the federal government and the states in which we conduct our business. The laws that may affect our ability to operate include:

☐ the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs; ☐ federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent; ☐ HIPAA, which created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters; ☐ HIPAA, as amended by the HITECH Act, and its implementing regulations, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information; and ☐ state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

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If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.

We face an inherent risk of product liability as a result of the clinical testing of our product candidates and will face an even greater risk for the commercialization of any products. For example, we may be sued if any product we develop allegedly causes injury or is found to be otherwise unsuitable during product testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability, and a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our product candidates, if approved. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:

☐ decreased demand for our product candidates or products that we may develop; ☐ injury to our reputation; ☐ withdrawal of clinical trial participants; ☐ initiation of investigations by regulators; ☐ restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market or voluntary or mandatory product recalls; ☐ costs to defend the related litigation; ☐ a diversion of management’s time and our resources; ☐ substantial monetary awards to trial participants or patients; ☐ product recalls, withdrawals or labeling, marketing or promotional restrictions; ☐ loss of revenues from product sales; and ☐ the inability to commercialize our product candidates.

Our inability to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of products we develop. We plan to carry product liability insurance and errors and omissions insurance that we believe is appropriate for our company. Any claim that may be brought against us could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by our insurance or that is in excess of the limits of our insurance coverage. Insurance policies also have various exclusions, and we may be subject to a product liability claim for which we have insufficient or no coverage. If we have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, we may not have, or be able to obtain, sufficient capital to pay such amounts. In addition, insurance coverage is becoming increasingly expensive, and we may not be able to maintain insurance coverage at a reasonable cost. We also may not be able to obtain additional insurance coverage that will be adequate to cover product liability risks that may arise. Consequently, a product liability claim may result in losses that could be material to our business, financial condition and results of operations.

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We will need to increase the size of our company and may not effectively manage our growth.

Our success will depend upon growing our business and our employee base. Over the next 12 months, we plan to add additional employees to assist us with research and development and our commercialization efforts. Our future growth, if any, may cause a significant strain on our management, and our operational, financial and other resources. Our ability to manage our growth effectively will require us to implement and improve our operational, financial and management systems and to expand, train, manage and motivate our employees. These demands may require the hiring of additional management personnel and the development of additional expertise by management. Any increase in resources devoted to research and product development without a corresponding increase in our operational, financial and management systems could have a material adverse effect on our business, financial condition, and results of operations.

Any disruption in our research and development facilities could adversely affect our business, financial condition and results of operations.

Our principal executive offices, which house our research and development programs, are in San Diego, California. Our facilities may be affected by natural or man-made disasters. Earthquakes are of particular significance since our facilities are located in an earthquake-prone area. We are also vulnerable to damage from other types of disasters, including power loss, attacks from extremist organizations, fires, floods and similar events. If our facilities are affected by a natural or man-made disaster, we may be forced to curtail our operations and/or rely on third-parties to perform some or all of our research and development activities. Although we believe we possess adequate insurance for damage to our property and the disruption of our business from casualties, such insurance may not be sufficient to cover all of our potential losses and may not continue to be available to us on acceptable terms, or at all. In the future, we may choose to expand our operations in either our existing facilities or in new facilities. If we expand our worldwide manufacturing locations, there can be no assurance that this expansion will occur without implementation difficulties, or at all.

Our business and operations would suffer in the event of system failures.

Despite the implementation of security measures, our internal computer systems and those of our CROs and other contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, cybersecurity attacks or hacking, natural disasters, terrorism, war and telecommunication and electrical failures. In addition, as a result of the COVID-19 pandemic, we may face increased cybersecurity risks due to our reliance, and the reliance of our CROs, contractors and consultants reliance, on internet technology and the number of our employees, and employees of our CROs, contractors and consultants, who are working remotely, which may create additional opportunities for cybercriminals to exploit vulnerabilities. While we have not experienced any such system failure, accident or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our drug development programs. For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach was to result in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur material legal claims and liability, damage to our reputation, suffer loss or harm to our intellectual property rights and the further research, development and commercial efforts of our products and product candidates could be delayed. If we are held liable for a claim against which we are not insured or for damages exceeding the limits of our insurance coverage, whether arising out of cybersecurity matters, or from some other matter, that claim could have a material adverse effect on our results of operations.

Further, a cybersecurity attack, data breach or privacy violation that leads to disclosure or modification of, or prevents access to, patient information, including personally identifiable information or protected health information, could harm our reputation, compel us to comply with federal and/or state breach notification laws and foreign law equivalents, subject us to mandatory corrective action, require us to verify the correctness of database contents and otherwise subject us to liability under laws and regulations that protect personal data, resulting in increased costs or loss of revenue. Portions of our information technology systems may experience interruptions, delays or cessations of service or produce errors in connection with ongoing systems implementation work. Cybersecurity attacks in particular are evolving and include, but are not limited to, threats, malicious software, ransom ware, attempts to gain unauthorized access to data and other electronic security breaches that could lead to disruptions in systems, misappropriation of confidential or otherwise protected information and corruption of data. If we are unable to prevent such cybersecurity attacks, data security breaches or privacy violations or implement satisfactory remedial measures, our operations could be disrupted, and we may suffer loss of reputation, financial loss and other regulatory penalties because of lost or misappropriated information, including sensitive patient data. In addition, these breaches and other inappropriate access can be difficult to detect, and any delay in identifying them may lead to increased harm of the type described above.

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Comprehensive tax reform legislation could adversely affect our business and financial condition.

Our effective income tax rate in the future could be adversely affected by a number of factors, including: changes in the mix of earnings in countries with differing statutory tax rates, changes in the valuation of deferred tax assets and liabilities, changes in tax laws, and the outcome of income tax audits in various jurisdictions. We regularly assess all of these matters to determine the adequacy of its tax provision, which is subject to significant discretion.

Compliance with changing regulations concerning corporate governance and public disclosure may result in additional expenses.

There have been changing laws, regulations and standards relating to corporate governance and public disclosure, including the Dodd-Frank Wall Street Reform and Consumer Protection Act (the “Dodd-Frank Act”), the Sarbanes-Oxley Act of 2002 (“Sarbanes-Oxley”), new regulations promulgated by the SEC and rules promulgated by the national securities exchanges. The Dodd-Frank Act, enacted in July 2010, expanded federal regulation of corporate governance matters and imposes requirements on public companies to, among other things, provides stockholders with a periodic advisory vote on executive compensation and also adds compensation committee reforms and enhanced pay-for-performance disclosures. While some provisions of the Dodd-Frank Act were effective upon enactment, others have been and will be implemented upon the SEC’s adoption of related rules and regulations. The scope and timing of the adoption of such rules and regulations is uncertain and, accordingly, the cost of compliance with the Dodd-Frank Act is also uncertain. Areas subject to potential change, amendment or repeal include the Dodd-Frank Act, including § 619 (12 U.S.C. § 1851) known as the Volcker Rule and various swaps and derivatives regulations, the authority of the Federal Reserve and the Financial Stability Oversight Council, and renewed proposals to separate banks’ commercial and investment banking activities.

These new or changed laws, regulations and standards are, or will be, subject to varying interpretations in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies, which could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. As a result, our efforts to comply with evolving laws, regulations and standards are likely to continue to result in increased general and administrative expenses and a diversion of management time and attention from revenue-generating activities to compliance activities. Members of our board of directors and our principal executive officer and principal financial officer could face an increased risk of personal liability in connection with the performance of their duties. As a result, we may have difficulty attracting and retaining qualified directors and executive officers, which could harm our business. If the actions we take in our efforts to comply with new or changed laws, regulations and standards differ from the actions intended by regulatory or governing bodies, we could be subject to liability under applicable laws or our reputation may be harmed.

We cannot provide assurance that our commercialization agreement with Verséa Ophthalmics, LLC will be successful.

On September 19, 2022 the Company announced that it had signed an exclusive global commercialization agreement with Verséa Ophthalmics, LLC, a business division of Verséa Holdings, Inc. (“Verséa”). We cannot provide assurances that this agreement will be successful and the loss of this key distributor could have a material adverse effect on our business, revenues and operating results.

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Risks Related to Acquisitions

We have acquired, and may in the future acquire, assets, businesses and technologies as part of our business strategy. If we acquire companies or technologies in the future, they could prove difficult to integrate, disrupt our business, dilute stockholder value, and adversely affect our operating results and the value of our common stock.

As part of our business strategy, we may acquire, enter into joint ventures with, or make investments in complementary or synergistic companies, services, and technologies in the future. Acquisitions and investments involve numerous risks, including without limitation:

☐ difficulties in identifying and acquiring products, technologies, proprietary rights or businesses that will help our business; ☐ difficulties in integrating operations, technologies, services, and personnel; ☐ diversion of financial and managerial resources from existing operations; ☐ the risk of entering new development activities and markets in which we have little to no experience; ☐ risks related to the assumption of known and unknown liabilities; ☐ risks related to our ability to raise sufficient capital to fund additional operating activities; and ☐ the issuance of our securities as partial or full payment for any acquisitions and investments could result in material dilution to our existing stockholders.

As a result, if we fail to properly evaluate acquisitions or investments, we may not achieve the anticipated benefits of any such acquisitions, we may incur costs in excess of what we anticipate, and management resources and attention may be diverted from other necessary or valuable activities.

Any acquisitions we make could disrupt our business and seriously harm our financial condition.

We have in the past made (and may, from time to time, consider) acquisitions of complementary companies, products or technologies. Acquisitions involve numerous risks, including difficulties in the assimilation of the acquired businesses, the diversion of our management’s attention from other business concerns and potential adverse effects on existing business relationships. In addition, any acquisitions could involve the incurrence of substantial additional indebtedness. We cannot assure you that we will be able to successfully integrate any acquisitions that we pursue or that such acquisitions will perform as planned or prove to be beneficial to our operations and cash flow. Any such failure could seriously harm our business, financial condition and results of operations.

Risks Related to Our Intellectual Property

Our ability to protect our intellectual property rights will be critically important to the success of our business, and we may not be able to protect these rights in the U.S. or abroad.

Our success, competitive position and future revenues will depend in part on our ability to obtain and maintain patent protection for our product candidates, methods, processes and other technologies, to prevent third parties from infringing on our proprietary rights, exclude others from using our technology and to operate without infringing upon the proprietary rights of third parties. We will be able to protect our proprietary rights from unauthorized use by third parties only to the extent that our proprietary rights are covered by valid and enforceable patents or are effectively maintained as trade secrets. We attempt to protect our proprietary position by maintaining trade secrets and by filing U.S. and foreign patent applications related to our proprietary technology, inventions and improvements that are important to the development of our business. The first of the patent applications related to our ongoing business operations was issued in 2020, and we continue to file additional patent applications for our product candidates and technology.

We have commenced generating a patent portfolio to protect each product candidate in our pipeline. However, the patent position of biopharmaceutical companies involves complex legal and factual questions, and therefore we cannot predict with certainty whether any patent applications that we have filed or that we may file in the future will be approved, will cover our products or product candidates or that any resulting patents will be enforced. In addition, third parties may challenge, seek to invalidate, limit the scope of or circumvent any of our patents, once they are issued. Thus, any patents that we own or license from third parties or joint venture or development partners may not provide any protection against competitors. Any patent applications that we have filed or that we may file in the future, or those we may license from third parties or joint venture or development partners, may not result in patents being issued. Moreover, disputes between our licensing or joint development partners and us may arise over license scope, or ownership, assignment, inventorship and/or rights to use or commercialize patent or other proprietary rights, which may adversely impact our ability to obtain and protect our proprietary technology and products. Also, patent rights may not provide us with adequate proprietary protection or competitive advantages against competitors with similar technologies or products.

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In addition, the laws of certain foreign countries do not protect our intellectual property rights to the same extent as do the laws of the U.S. If we fail to apply for intellectual property protection or if we cannot adequately protect our intellectual property rights in these foreign countries, our competitors may be able to compete more effectively against us, which could adversely affect our competitive position, as well as our business, financial condition and results of operations.

Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to the PTO and various foreign patent offices at various points over the lifetime of our patents and/or applications. We have systems in place to remind us to pay these fees, and we rely on our outside counsel or service providers to pay these fees when due. Additionally, the PTO and various foreign patent offices require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. We employ reputable law firms and other professionals to help us comply, and in many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with rules applicable to the particular jurisdiction. However, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. If such an event were to occur, it could have a material adverse effect on our business. In addition, we are responsible for the payment of patent fees for patent rights that we have licensed from other parties. If any licensor of these patents does not itself elect to make these payments, and we fail to do so, we may be liable to the licensor for any costs and consequences of any resulting loss of patent rights.

We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.

Competitors may infringe our patents, trademarks, copyrights or other intellectual property. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time consuming and divert the time and attention of our management and scientific personnel. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their patents, in addition to counterclaims asserting that our patents are invalid or unenforceable, or both. In any patent infringement proceeding, there is a risk that a court will decide that a patent of ours is invalid or unenforceable, in whole or in part, and that we do not have the right to stop the other party from using the invention at issue. There is also a risk that, even if the validity of such patents is upheld, the court will construe the patent’s claims narrowly or decide that we do not have the right to stop the other party from using the invention at issue on the grounds that our patent claims do not cover the invention. An adverse outcome in a litigation or proceeding involving our patents could limit our ability to assert our patents against those parties or other competitors, and may curtail or preclude our ability to exclude third parties from making and selling similar or competitive products. Any of these occurrences could adversely affect our competitive business position, business prospects and financial condition. Similarly, if we assert trademark infringement claims, a court may determine that the marks we have asserted are invalid or unenforceable, or that the party against whom we have asserted trademark infringement has superior rights to the marks in question. In this case, we could ultimately be forced to cease use of such trademarks.

Even if we establish infringement, the court may decide not to grant an injunction against further infringing activity and instead award only monetary damages, which may or may not be an adequate remedy. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of shares of our common stock. Moreover, there can be no assurance that we will have sufficient financial or other resources to file and pursue such infringement claims, which typically last for years before they are concluded. Even if we ultimately prevail in such claims, the monetary cost of such litigation and the diversion of the attention of our management and scientific personnel could outweigh any benefit we receive as a result of the proceedings.

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Our long-term success depends on intellectual property protection; if our intellectual property rights are invalidated or circumvented, our business will be adversely affected.

Our long-term success depends on our ability to continually discover, develop and commercialize innovative new pharmaceutical products. Without strong intellectual property protection, we may be unable to generate the returns necessary to support the enormous investments in research and development and capital as well as other expenditures required to bring new drugs to the market and for commercialization.

Intellectual property protection varies throughout the world and is subject to change over time. In the U.S., for small molecule drug products, such as SPX-009 (which is held by our subsidiary, Sapphire), the Hatch-Waxman Act provides generic companies powerful incentives to seek to invalidate our pharmaceutical patents. As a result, we expect that our U.S. patents on major pharmaceutical products will be routinely challenged, and there can be no assurance that our patents will be upheld. We face generic manufacturer challenges to our patents outside the U.S. as well. In addition, competitors or other third parties may claim that our activities infringe patents or other intellectual property rights held by them. If successful, such claims could result in our being unable to market a product in a particular territory or being required to pay damages for past infringement or royalties on future sales.

If any of our trade secrets, know-how or other proprietary information is disclosed, the value of our trade secrets, know-how and other proprietary rights would be significantly impaired and our business and competitive position would suffer.

Our success also depends upon the skills, knowledge and experience of our scientific and technical personnel and our consultants and advisors, as well as our licensors. To help protect our proprietary know-how and our inventions for which patents may be unobtainable or difficult to obtain, or prior to seeking patent protection, we rely on trade secret protection and confidentiality agreements. Unlike some of our competitors, in addition to certain manufacturing processes, we maintain our proprietary libraries for ourselves as trade secrets. To this end, we require all our employees, consultants, advisors and contractors to enter into agreements which prohibit the disclosure of confidential information and, where applicable, require disclosure and assignment to us of the ideas, developments, discoveries and inventions important to our business. These agreements may not provide adequate protection for our trade secrets, know-how or other proprietary information in the event of any unauthorized use or disclosure or the lawful development by others of such information. If any of our trade secrets, know-how or other proprietary information is disclosed, the value of our trade secrets, know-how and other proprietary rights would be significantly impaired and our business and competitive position would suffer. Moreover, our third-party licensing partners may retain rights in some of our proprietary or joint trade secrets, know-how, patented inventions or other proprietary information, including rights to sublicense and rights of publication, which may adversely impact our ability to obtain patents and protect trade secrets, know-how or other proprietary information. In addition, the U.S. government may retain rights in some of our patents or other proprietary information.

In addition, many of the formulations used and processes developed by us in manufacturing any of our collaborators’ products are subject to trade secret protection, patents or other intellectual property protections owned or licensed by such collaborator. While we make significant efforts to protect our collaborators’ proprietary and confidential information, including requiring our employees to enter into agreements protecting such information, if any of our employees breaches the non-disclosure provisions in such agreements, or if our collaborators make claims that their proprietary information has been disclosed, our reputation may suffer damage and we may become subject to legal proceedings that could require us to incur significant expenses and divert our management’s time, attention and resources.

Claims that we infringe upon the rights of third parties may give rise to costly and lengthy litigation, and we could be prevented from selling products, forced to pay damages, and defend against litigation.

Third parties may assert patent or other intellectual property infringement claims against us or our strategic partners or licensees with respect to our technologies and product candidates or potential product candidates. If our products, methods, processes and other technologies infringe upon the proprietary rights of other parties, we could incur substantial costs and we may have to:

☐ obtain licenses, which may not be available on commercially reasonable terms, if at all, and may be non-exclusive, thereby giving our competitors access to the same intellectual property licensed to us; ☐ redesign our products or processes to avoid infringement; ☐ stop using the subject matter validly claimed in the patents held by others; ☐ pay damages; and ☐ defend litigation or administrative proceedings which may be costly whether we win or lose, and which could result in a substantial diversion of our valuable management resources.

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Even if we were to prevail, any litigation could be costly and time-consuming and would divert the attention of our management and key personnel from our business operations. Furthermore, as a result of a patent infringement suit brought against us or our strategic partners or licensees, we or our strategic partners or licensees may be forced to stop or delay developing, manufacturing or selling technologies, product candidates or potential products that are claimed to infringe a third party’s intellectual property unless that party grants us or our strategic partners’ or licensees’ rights to use its intellectual property. Ultimately, we may be unable to develop some of our technologies or potential products or may have to discontinue development of a product candidate or cease some of our business operations as a result of patent infringement claims, which could severely harm our business.

In addition, our collaborators’ products may be subject to claims of intellectual property infringement and such claims could materially affect our business if their products cease to be manufactured and they have to discontinue the use of the infringing technology which we may provide. Any of the foregoing could affect our ability to compete or could have a material adverse effect on our business, financial condition and results of operations.

Our position as a relatively small company may cause us to be at a significant disadvantage in defending our intellectual property rights and in defending against infringement claims by third parties.

Litigation relating to the ownership and use of intellectual property is expensive, and our position as a small company in an industry dominated by very large companies may cause us to be at a significant disadvantage in defending our intellectual property rights and in defending against claims that our technology infringes or misappropriates third party intellectual property rights. However, we may seek to use various post-grant administrative proceedings, including new procedures created under the America Invents Act, to invalidate potentially overly-broad third party rights. Even if we can defend our position, the cost of doing so may adversely affect our ability to grow, generate revenue or become profitable. In the course of the ongoing litigation or any future additional litigation to which we may be subject, we may not be able to protect our intellectual property at a reasonable cost, or at all. The outcome of litigation is always uncertain, and in some cases could include judgments against us that require us to pay damages, enjoin us from certain activities or otherwise affect our legal, contractual or intellectual property rights, which could have a significant adverse effect on our business.

Third-party claims of intellectual property infringement may prevent or delay our drug discovery and development efforts.

Our commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties.

There is a substantial amount of litigation involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including PTO administrative proceedings, such as inter parties reviews, and reexamination proceedings before the PTO or oppositions and revocations and other comparable proceedings in foreign jurisdictions. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are developing product candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our product candidates may give rise to claims of infringement of the patent rights of others.

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Despite safe harbor provisions, third parties may assert that we are employing their proprietary technology without authorization. There may be third-party patents, of which we are currently unaware, with claims to materials, formulations, methods of doing research or library screening, methods of manufacture or methods for treatment related to the use or manufacture of our product candidates. Because patent applications can take many years to issue, there may be currently pending patent published applications which may later result in issued patents that our product candidates may infringe. In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents. If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of any of our product candidates, any molecules formed during the manufacturing process or any final product itself, the holders of any such patents may be able to block our ability to commercialize such product candidate unless we obtain a license under the applicable patents, or until such patents expire or they are finally determined to be held invalid or unenforceable. Similarly, if any third-party patent were held by a court of competent jurisdiction to cover aspects of our formulations, processes for manufacture or methods of use, including combination therapy or patient selection methods, the holders of any such patent may be able to block our ability to develop and commercialize the applicable product candidate unless we obtain a license, limit our uses, or until such patent expires or is finally determined to be held invalid or unenforceable. In either case, such a license may not be available on commercially reasonable terms or at all.

Parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize one or more of our product candidates. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, cease marketing our products or developing our product candidates, limit our uses, pay royalties or redesign our infringing product candidates, which may be impossible or require substantial time and monetary expenditure. We cannot predict whether any such license would be available at all or whether it would be available on commercially reasonable terms. Furthermore, even in the absence of litigation, we may need to obtain licenses from third parties to advance our research or allow commercialization of our product candidates. We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In that event, we would be unable to further develop and commercialize one or more of our product candidates, which could harm our business significantly.

We may not be able to protect our intellectual property rights throughout the world.

Filing, prosecuting and defending patents on all of our product candidates throughout the world would be prohibitively expensive. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the U.S. These products may compete with our products in jurisdictions where we do not have any issued patents and our patent claims or other intellectual property rights may not be effective or sufficient to prevent them from so competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biopharmaceuticals, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business.

If we breach any of the agreements under which we license commercialization rights to our product candidates from third parties, we could lose license rights that are important to our business.

We license the use, development and commercialization rights for some of our product candidates and may enter into similar licenses in the future. Under our existing license agreements, we are subject to commercialization and development, diligence obligations, milestone payment obligations, royalty payments and other obligations. If we fail to comply with any of these obligations or otherwise breach our license agreements, our licensing partners may have the right to terminate the license in whole or in part.

Generally, the loss of any one of our current licenses or other licenses in the future could materially harm our business, prospects, financial condition and results of operations.

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Intellectual property rights do not necessarily address all potential threats to our competitive advantage.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect our business, or permit us to maintain our competitive advantage. The following examples are illustrative:

☐ Others may be able to make compounds that are similar to our product candidates but that are not covered by the claims of the patents that we own or have exclusively licensed; ☐ We or our licensors or strategic partners might not have been the first to make the inventions covered by the issued patent or pending patent application that we own or have exclusively licensed; ☐ We or our licensors or strategic partners might not have been the first to file patent applications covering certain of our inventions; ☐ Others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; ☐ Our pending patent applications may not lead to issued patents; ☐ Issued patents that we own or have exclusively licensed may not provide us with any competitive advantages, or may be held invalid or unenforceable, as a result of legal challenges by our competitors; ☐ Our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; ☐ We may not develop additional proprietary technologies that are patentable; and ☐ The patents of others may have an adverse effect on our business.

Should any of these events occur, they could significantly harm our business, results of operations and prospects.

Risks Related to Ownership of Our Common Stock

The market price of our common stock may fluctuate significantly, and investors in our common stock may lose all or a part of their investment.

The market prices for securities of biotechnology and pharmaceutical companies have historically been highly volatile, and the market has from time-to-time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. For example, from January 1, 2022 to December 31, 2022, our closing stock price ranged from $0.027 to $0.399 per share. The market price of our common stock may fluctuate significantly in response to numerous factors, some of which are beyond our control, such as:

☐ actual or anticipated adverse results or delays in our clinical trials; ☐ our failure to commercialize our product candidates, if approved; ☐ unanticipated serious safety concerns related to the use of any of our product candidates; ☐ adverse regulatory decisions; ☐ changes in laws or regulations applicable to our product candidates, including but not limited to clinical trial requirements for approvals; ☐ legal disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our product candidates, government investigations and the results of any proceedings or lawsuits, including, but not limited to, patent or stockholder litigation; ☐ our decision to initiate a clinical trial, not initiate a clinical trial or to terminate an existing clinical trial; ☐ our dependence on third parties, including CROs; ☐ announcements of the introduction of new products by our competitors; ☐ market conditions in the pharmaceutical and biotechnology sectors; ☐ announcements concerning product development results or intellectual property rights of others;

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☐ future issuances of common stock or other securities; ☐ the addition or departure of key personnel; ☐ failure to meet or exceed any financial guidance or expectations regarding development milestones that we may provide to the public; ☐ actual or anticipated variations in quarterly operating results; ☐ our failure to meet or exceed the estimates and projections of the investment community; ☐ overall performance of the equity markets and other factors that may be unrelated to our operating performance or the operating performance of our competitors, including changes in market valuations of similar companies; ☐ conditions or trends in the biotechnology and biopharmaceutical industries; ☐ introduction of new products offered by us or our competitors; ☐ announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors; ☐ issuances of debt or equity securities; ☐ sales of our common stock by us or our stockholders in the future; ☐ trading volume of our common stock; ☐ ineffectiveness of our internal controls; ☐ publication of research reports about us or our industry or positive or negative recommendations or withdrawal of research coverage by securities analysts; ☐ failure to effectively integrate the acquired companies’ operations; ☐ general political and economic conditions; ☐ effects of natural or man-made catastrophic events; ☐ effects of public health crises, pandemics and epidemics, such as the COVID-19 pandemic; and ☐ other events or factors, many of which are beyond our control.

Further, the equity markets in general have recently experienced extreme price and volume fluctuations. Continued market fluctuations could result in extreme volatility in the price of our common stock, which could cause a decline in the value of our common stock. Price volatility of our common stock might worsen if the trading volume of our common stock is low. The realization of any of the above risks or any of a broad range of other risks, including those described in these “Risk Factors,” could have a dramatic and material adverse impact on the market price of our common stock.

We have never paid cash dividends and do not expect to pay cash dividends in the foreseeable future. Any return on investment may be limited to the value of our common stock.

We have never paid cash dividends on our common stock and do not anticipate paying cash dividends on our common stock in the foreseeable future. The payment of dividends on our capital stock will depend on our earnings, financial condition and other business and economic factors affecting us at such time as the board of directors may consider relevant. We currently anticipate that we will re-invest any funds that we receive into the business to further our business strategy, and not to pay dividends. If we do not pay dividends, our common stock may be less valuable because a return on your investment will only occur if the common stock price appreciates.

A sale of a substantial number of shares of the common stock may cause the price of our common stock to decline.

If our stockholders sell, or the market perceives that our stockholders intend to sell for various reasons, substantial amounts of our common stock in the public market, including shares issued in connection with the exercise of outstanding options or warrants, the market price of our common stock could fall. Sales of a substantial number of shares of our common stock may make it more difficult for us to sell equity or equity-related securities in the future at a time and price that we deem reasonable or appropriate. We may become involved in securities class action litigation that could divert management’s attention and harm our business.

The stock markets have from time-to-time experienced significant price and volume fluctuations that have affected the market prices for the common stock of biotechnology and biopharmaceutical companies. These broad market fluctuations may cause the market price of our common stock to decline. In the past, securities class action litigation has often been brought against a company following a decline in the market price of our securities. This risk is especially relevant for us because biotechnology and biopharmaceutical companies have experienced significant stock price volatility in recent years. We may become involved in this type of litigation in the future. Litigation often is expensive and diverts management’s attention and resources, which could adversely affect our business.

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Our quarterly operating results may fluctuate significantly.

We expect our operating results to be subject to quarterly fluctuations. Our net loss and other operating results will be affected by numerous factors, including:

☐ variations in the level of expenses related to our development programs; ☐ the addition or termination of clinical trials; ☐ any intellectual property infringement lawsuit in which we may become involved; ☐ regulatory developments affecting our product candidates; and ☐ our execution of any collaborative, licensing or similar arrangements, and the timing of payments we may make or receive under these arrangements.

If our quarterly operating results fall below the expectations of investors or securities analysts, the price of our common stock could decline substantially. Furthermore, any quarterly fluctuations in our operating results may, in turn, cause the price of our common stock to fluctuate substantially.

Existing stockholders’ interest in us may be diluted by additional issuances of equity securities and raising funds through acquisitions, lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights.

We may issue additional equity securities to fund future expansion and pursuant to equity incentive or employee benefit plans. We may also issue additional equity for other purposes. These securities may have the same rights as our common stock or, alternatively, may have dividend, liquidation or other preferences to our common stock. The issuance of additional equity securities will dilute the holdings of existing stockholders and may reduce the share price of our common stock.

If we raise additional funds through collaboration, licensing or other similar arrangements, it may be necessary to relinquish potentially valuable rights to our product candidates, potential products or proprietary technologies, or grant licenses on terms that may not be favorable to us. If adequate funds are not available, our ability to achieve profitability or to respond to competitive pressures would be significantly limited and we may be required to delay, significantly curtail or eliminate the development of our product candidates.

Our investors could experience substantial dilution of their investments as a result of subsequent exercises of our outstanding options, including the CEO Performance Award, or the grant of future equity awards by us.

As of December 31, 2022, 40 million shares of our common stock were authorized for issuance under our 2015 Stock Incentive Plan, of which 19,860,715 shares of our common stock were subject to options outstanding at such date at a weighted-average exercise price of $0.49 per share. To the extent outstanding options are exercised, our existing stockholders may incur dilution.

We rely on equity awards to motivate current employees and to attract new employees. The grant of future equity awards by us to our employees and other service providers may further dilute our stockholders.

Our directors and executive officers own a significant percentage of our capital stock, and they may make decisions that you do not consider to be in your best interests or those of our other stockholders.

As of December 31, 2022, our directors and executive officers beneficially owned, in the aggregate, approximately 67.02% of our outstanding voting securities. As a result, if some or all of them acted together, they would have the ability to exert significant influence over the election of our board of directors and the outcome of issues requiring approval by our stockholders. This concentration of ownership may also have the effect of delaying or preventing a change in control of our company that may be favored by other stockholders. This could prevent transactions in which stockholders might otherwise recover a premium for their shares over current market prices.

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Our articles of incorporation, as amended, and bylaws provide for indemnification of officers and directors at our expense and limits their liability, which may result in a major cost to us and hurt the interests of our stockholders because corporate resources may be expended for the benefit of our officers and/or directors.

Our articles of incorporation, as amended, bylaws and applicable Nevada law provide for the indemnification of our directors, officers, employees, and agents, under certain circumstances, against attorney’s fees and other expenses incurred by them in any litigation to which they become a party arising from their association with or activities on our behalf. We will also bear the expenses of such litigation for any of our directors, officers, employees, or agents, upon such person’s promise to repay us, therefore if it is ultimately determined that any such person shall not have been entitled to indemnification. This indemnification policy could result in substantial expenditures by us, which we will be unable to recover.

We have issued Preferred Stock.

Our articles of incorporation, as amended, authorize the issuance of up to 5,000,000 shares of preferred stock with designations, rights and preferences determined from time to time by our Board of Directors. As of December 31, 2022, of the 5,000,000 preferred shares authorized: (i) 1,000,000 shares were designated as Series A Convertible Preferred Stock, of which none were issued and outstanding, (ii) 500,000 shares were designated as Series B Convertible Preferred Stock, of which none were issued and outstanding, and (iii) 500,000 shares were designated as Series C Convertible Preferred Stock (“Series C Preferred Stock”), of which 500,000 shares were issued and outstanding. The holders of our Series C Preferred Stock have voting control of the Company. Our Board of Directors is empowered, without stockholder approval, to designate and issue preferred stock with dividend, liquidation, conversion, voting, or other rights which could adversely affect the voting power or other rights of the holders of the common stock. The issuance of additional shares of preferred stock could be utilized, under certain circumstances, as a method of discouraging, delaying or preventing a change in control of the Company.

Item 1B. Unresolved Staff Comments

None.

Item 2. Properties

Executive Office and Laboratory Address:

We lease approximately 1,908 sq. ft. of Executive Office and Laboratory space located at 6191 Cornerstone Court, E. Suite 114, San Diego, CA 92121. Base rent is $5,000 per month plus additional CAM and utility costs. Our current lease expires in April 2023.

Item 3. Legal Proceedings

We are subject to litigation, claims, investigations and audits arising from time to time in the ordinary course of our business. However, at this time, we are not aware on any material pending, threatened or unasserted claims.

Item 4. Mine Safety Disclosure

Not applicable.

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PART II

Item 5. Market for Registrant’s Common Equity and Related Stockholder Matters and Issuer Purchases of Equity Securities

Our common stock is currently traded on the OTCQB under trading symbol “AXIM.” An active public market for our common stock may not develop or be sustained. Trading of securities on the OTCQB is often sporadic and investors may have difficulty buying and selling or obtaining market quotations. Any OTCQB market quotations reflect inter-dealer quotations, without adjustment for retail mark-up, mark-down or commission and may not necessarily represent actual transactions.

The following table sets forth the high and low closing bid prices for our common stock as reported on OTCQB for the following periods. These prices do not include retail mark-ups, markdowns or commissions, and may not necessarily represent actual transactions.

	High ($)		Low ($)
Fiscal Year Ended December 31, 2022
First Quarter		0.399		0.125
Second Quarter		0.13		0.056
Third Quarter		0.107		0.04
Fourth Quarter		0.104		0.027
Fiscal Year Ended December 31, 2021
First Quarter		0.85		0.41
Second Quarter		1.20		0.50
Third Quarter		0.99		0.56
Fourth Quarter		0.56		0.26

As of April 12, 2023, there are 156 holders of record of our common stock. This number does not include beneficial holders of our common stock. Because many of our shares of common stock are held by brokers and other institutions on behalf of shareholders, we are unable to estimate the total number of shareholders represented by these record holders.

Dividends

We have never declared or paid cash dividends on our common stock. We anticipate that in the future we will retain any earnings for operation of our business. Accordingly, we do not anticipate declaring or paying any cash dividends in the foreseeable future.

Securities Authorized for Issuance Under Equity Compensation Plans

The company adopted its 2015 Stock Incentive Plan, effective May 29, 2015, under which eligible persons or vendors whom provide the company services may be afforded an opportunity to acquire an equity interest in the company in exchange for those services provided. The 2015 Stock Incentive Plan was amended effective December 24, 2021.

The following table provides information as of December 31, 2022, regarding our equity compensation plans:

Plan Category	Number of securities to be issuedupon exercise ofoutstanding options,warrants and rights		Weighted-average exercise priceof outstanding options,warrants and rights		Number of securities remaining availablefor future issuanceunder equitycompensation plans
Equity compensation plans approved by security holders		19,860,715	$	0.49		30,139,285
Equity compensation plans not approved by security holders		–		–		–
Total		19,860,715	$	0.49		30,139,285

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Unregistered Sales of Equity Securities and Use of Proceeds

The Company did not sell any securities that were not registered under the Securities Act of 1933, as amended, during fiscal year 2022 that have not already been reported on a Current Report on Form 8-K or a Quarterly Report on Form 10-Q.

During the year ended December 31, 2022, the Company entered into Various Stock Purchase agreements which generated cash of $455,000.

Issuer Repurchases of Equity Securities

None.

Item 6. [Reserved]

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of our financial condition and results of operations for the years ended December 31, ~~2022~~2023 and ~~2021~~2022 should be read in conjunction with the financial statements and the notes to those statements that are included elsewhere in this Annual Report on Form 10-K. Our discussion includes forward-looking statements based upon current expectations that involve risks and uncertainties, such as our plans, objectives, expectations and intentions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of a number of factors. We use words such as “anticipate,” “estimate,” “plan,” “project,” “continuing,” “ongoing,” “expect,” “believe,” “intend,” “may,” “will,” “should,” “could,” and similar expressions to identify forward-looking statements.

Liquidity and Capital Resources

We are in our early stages of development and growth, without established records of sales or earnings. We will be subject to numerous risks inherent in the business and operations of financially unstable and early stage or emerging growth companies.

As of December 31, ~~2022~~2023, we had cash and cash equivalents of $47156,~~282~~457, working capital deficit of $(35,~~288~~821,~~515~~960), and an accumulated deficit of $6472,~~125~~184,~~176~~858. We estimate our G&A expenses for ~~2023~~2024 to be approximately $3,500,000, which includes projected audit and accounting costs of $250,000. R&D expenses for ~~2023~~2024 will vary based on drug formulation and clinical trial project activity that the Company is engaged in, which in turn is determined by available capital. R&D expenditures in ~~2023~~2024 will depend on available cash flow and the extent of additional capital funding.

We can provide no assurance that the Company can continue to satisfy its cash requirements for at least the next twelve months.

We expect to obtain financing through shareholder loans, private placements and/or registered offerings of our securities. Shareholder loans may be without stated terms of repayment or interest. In addition, we may consider taking on long-term or short-term debt from financial institutions in the immediate future. Shareholders loans may be granted from time to time as required to meet current working capital needs. We have no formal agreement that ensures that we will receive such loans. We may exhaust this source of funding at any time.

We are dependent upon certain related parties to provide continued funding and capital resources. If continued funding and capital resources are unavailable at reasonable terms, we may not be able to implement our plan of operations. These loans may include terms that may be highly dilutive to existing shareholders.

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On September 14, 2017, our Registration Statement on Form S-3 was declared effective by the SEC. We issued 20,977,638 shares common stock pursuant to the Company’s Registration Statement on Form S-3 and S-1 during the year ending December 31, 2022. We issued 7,494,792 shares common stock pursuant to the Company’s Registration Statement on Form S-3 during the year ending December 31, 2020. No shares were issued in 2021 under the S-3.

On June 22, 2021, our Registration Statement on Form S-1 was declared effective by the SEC. We issued 1,000,000 shares of Company common stock pursuant to an equity purchase agreement, dated on May 14, 2021, and the Registration Statement on Form S-1 during the year ending December 31, 2021. Subsequent to the year ended December 31, 2022, the Company issued an additional 8,000,000 shares of its common stock for cash of $130,000 pursuant to the equity purchase agreement, which shares were also registered pursuant to the S-3 Registration Statement.

During January 2022, the Company issued 612,104 shares for cash of gross proceeds of $75,000 pursuant to various stock purchase agreements. The cash was received in the fourth quarter 2021 and first quarter 2022. The Company also issued warrants to purchase an aggregate of 612,104 shares of common stock at an average exercise price of $0.315 per share. The warrants are exercisable within a three-year period from issuance.

Effective February 10, 2022, the Company issued two short term notes, each having a face amount of $250,000, in exchange for a total of $500,000 in cash (the “Short Term Promissory Notes”). The Short Term Promissory Notes bear interest at the rate of 1.5% per annum and were due and payable on or before March 10, 2022, unless demand for payment is made prior to such date. One of the two notes was paid in full on February 14, 2022.

Effective February 10, 2022, the Company issued seven convertible notes to a series of investors having an aggregate face value of $1,325,000 in exchange for $1,325,000 in cash (the “Convertible Notes”). One of the Convertible Notes, face value $25,000, was purchased by Blake N. Schroeder who is a director of the Company.

Each of the Convertible Notes is (i) unsecured; (ii) bears interest at a rate of 3% per annum; (iii) matures on February 10, 2032; and (iv) is convertible, in whole or in part, at any time by the holder, into restricted shares of the Company’s common stock at a conversion price equal to the lesser of $0.08125 or 70% of the average of the two lowest closing prices of the Company’s common stock in the ten trading days preceding any particular conversion, provided, the holder is prohibited from converting the convertible note, or portion thereof, if such conversion would result in beneficial ownership by the holder and its affiliates of more than 4.99% of Company’s issued and outstanding common stock as of the date of the conversion.

On February 10, 2022, the Company paid in full the remaining balance due on that certain convertible note issued to GS Capital Partners, LLC, face value $1,110,000 (as amended, the “GS Note”). In connection with the repayment, the Company was required to pay accrued interest in the amount of $21,875, by issuing 173,390 restricted shares of the Company’s common stock pursuant to the formula set forth in the GS Note.

During 2022, the Company issued 14,837,874 of its shares of common stock pursuant to a stock purchase agreement for cash gross proceeds of $455,000.

In January 2022 the company issued 7,000,000 of its shares in completion of its agreement with Advanced Tear Diagnostics regarding the purchase of various patents.

During 2023 the Company issued 23,000,000 shares of its stock pursuant to its S-1 which generated cash of $514,931.

During 2023 the company issued 22,207,486 shares of its stock to convert various notes payable valued at $688,432.

In December 2023 the company issued 7,280,000 shares of its stock in exchange for equipment valued at $152,800.

In December 2019, a novel strain of coronavirus (“COVID-19”) was reported in Wuhan, China. The COVID-19 pandemic, as it was declared by the World Health Organization, has continued to spread and has already caused severe global disruptions. The extent of COVID-19’s effect on our operational and financial performance will depend on future developments, including the duration, spread and intensity of the pandemic, all of which are uncertain and difficult to predict considering the rapidly evolving landscape.

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We expect COVID-19, along with the resulting government-imposed restrictions on businesses, to negatively impact our operations due to decreased consumer demand as well as potential production and warehouse limitations which results in an event or condition, before consideration of management’s plans, that could impact our ability to meet future obligations. We believe that our cash and cash equivalents on hand and these cost reduction measures, as needed, will provide sufficient liquidity to fund our operations for the next 12 months from the issuance of the consolidated financial statements.

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Sources of Capital

We expect to sustain our working capital needs through shareholder loans, private placements and/or registered offerings of our securities. Shareholder loans may be without stated terms of repayment or interest. We may consider taking on any long-term or short-term debt from financial institutions in the immediate future. Shareholders loans may be granted from time to time as required to meet current working capital needs. We have no formal agreement that ensures that we will receive such loans. We may exhaust this source of funding at any time.

During the next twelve months, we anticipate incurring costs related to:

	(i)	filing Exchange Act reports;
	(ii)	contractual obligations;
	(iii)	building inventory of our approved devices;
	(iii)	clinical trials; and
	(iv)	continued research and development of our diagnostic tests.

We believe we will be able to meet these costs through use of funds in our treasury, deferral of fees by certain service providers and additional amounts, as necessary, to be loaned to or invested in us by our shareholders, management or other investors. As of the date of the period covered by this report, we have limited cash. There are no assurances that we will be able to secure any additional funding as needed. Currently, however our ability to continue as a going concern is dependent upon our ability to generate future profitable operations and/or to obtain the necessary financing to meet our obligations and repay our liabilities arising from normal business operations when they come due. Management’s plan includes obtaining additional funds by equity financing and/or related party advances; however, there is no assurance of additional funding being available.

Known Trends or Uncertainties

We have seen some consolidation in the pharmaceutical and biotechnology industries during economic downturns. These consolidations have not had a negative effect on us to date; however, should consolidations and downsizing in the industry continue to occur, those events could adversely impact our financial results and business operations going forward.

The potential for growth in new markets is uncertain. We will continue to explore these opportunities until such time as we either generate sales or determine that resources would be more efficiently used elsewhere.

As discussed in this Annual Report, the world has been affected due to the COVID-19 pandemic. The pandemic has negatively impacted our business in various ways over the last two years, including, more recently, as a result of global supply chain constraints at least partially attributable to the pandemic. Until the pandemic has passed, there remains uncertainty as to the effect of COVID-19 on our business in both the short and long-term.

Inflation

Inflation has increased during the periods covered by this Annual Report, and is expected to continue to increase for the near future. Inflationary factors, such as increases in the cost of our products (and components thereof), interest rates, overhead costs and transportation costs may adversely affect our operating results. Although we do not believe that inflation has had a material impact on our financial position or results of operations to date, we may experience some effect in the near future (especially if inflation rates continue to rise) due to supply chain constraints, consequences associated with COVID-19 and the ongoing ~~conflict~~conflicts between Russia and Ukraine, and Israel/Hamas, employee availability and wage increases, trade tariffs imposed on certain products from China and increased product pricing due to semiconductor product shortages.

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Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.

Going Concern

The Company’s financial statements have been presented assuming that the Company will continue as a going concern. As shown in the financial statements, the Company has negative working capital of $35,~~288~~821,~~515~~960, has an accumulated deficit of $6472,~~125~~184,~~176~~858 has cash used in ~~continuing~~ operating activities of $21,~~044~~030,~~326~~500 and presently does not have the resources to accomplish its objectives during the next twelve months. These conditions raise substantial doubt about the ability of the Company to continue as a going concern. The financial statements do not include any adjustments related to the recoverability of assets and classification of liabilities that might be necessary should the Company be unable to continue in operation.

The Company may not be able to meet its contractual obligations to Arizona State University regarding ongoing research and maintain its staff at current levels required by various employment agreements.

The Company intends to raise additional capital through private placements and/or registered offerings of debt and equity securities, but there can be no assurance that these funds will be available on terms acceptable to the Company or will be sufficient to enable the Company to fully complete its development activities or sustain operations. If the Company is unable to raise sufficient additional funds, it will have to develop and implement a plan to further extend payables, reduce overhead, or scale back its current business plan until sufficient additional capital is raised to support further operations. There can be no assurance that such a plan will be successful.

Results of Operations

Comparison of the year ended December 31, ~~2022~~2023 and ~~2021~~2022.

	December 31, 2022			December 31, 2021			$ Change			% Change
	December 31, 2023			December 31, 2022			$ Change			% Change
Revenues	$	839,~~875~~518		$	608,~~460~~875		$	~~(51~~30,~~585~~643	)	>	~~-85~~100	%
Gross margin percentage		-			-			-			-
Operating expenses		42,~~661~~790,~~647~~357			144,~~035~~661,~~458~~647			(91,~~373~~871,~~811~~290	)	>	~~-67~~(41	)%
Loss from continuing operations		(4,652,772	)		(13,974,998	)		(9,322,226	)	>	-67	%
Loss from operations		(2,750,839	)		(4,652,772	)		(1,901,933	)	>	(41	)%
Loss from discontinued operations					(7,996	)		7,996			-100	%
Other expenses (income)		5,308,843			1,590,177			3,718,666		>	100	%
Other expenses (income)		1,590,177			2,049,311			(459,134	)		-22.4	%
Net loss	$	(8,059,682	)	$	(6,242,949	)	$	1,816,733		>	29	%
Net loss	$	(6,242,949	)	$	(16,032,305	)	$	(9,789,356	)	>	-139	%

Revenue

Revenues from ~~continuing~~ operations recognized for twelve months ended December 31, ~~2022~~2023 and ~~2021~~2022 amounted to $839,~~875~~518 and $608,~~460~~875, respectively. ~~The decrease in revenue from continuing operations is due to the termination Co-production agreement with empowered diagnostics.~~

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Cost of Revenue

Cost of Revenue from ~~continuing~~ operations recognized for twelve months ended December 31, ~~2022~~2023, and ~~2021~~2022 amounted to $-0- and $-0-, respectively. The lack of COGS is due to lack of sales of products to customers in ~~2022 This is due primarily to discontinued sale activities of Wellness gum in 2021~~2023.

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Operating Expenses

Research and Development Expenses

For the twelve months ended December 31, ~~2022~~2023 and ~~2021~~2022 the Company incurred research and development expenses of $~~153~~125,~~697~~496 and $~~284~~153,~~869~~697 from ~~continuing~~ operations, respectively The decrease is primarily due to discontinued research and clinical activities because of ~~Wellness gum and~~ lack of cash resources.

Selling, General and Administrative Expenses

Our Selling, General and Administrative expenses for the years ending in ~~2022~~2023 and ~~2021~~2022 were $42,~~081~~308,~~824~~569 and $54,~~668~~081,~~240~~824, respectively. ~~The decrease is primarily due to the write off of the acquisition of Sapphire Biotech on 2021.~~

Depreciation Expenses

For the year ended December 31, ~~2022~~2023 our depreciation expenses were $3132,~~680~~573 as compared to $2731,~~779~~680 for the year ended December 31, ~~2021~~2022. The increase is primarily due to recognizing the property and equipment as a result of the acquisition of Laboratory equipment for the Eye Care division.

Amortization Expenses

For the year ended December 31, ~~2022~~2023 our amortization expenses were $394,446 as compared to $2394,~~087,908~~446 for the year ended December 31, ~~2021~~2022. The ~~decrease~~amortization is primarily due to recognizing the write off intangible assets as a result of the acquisition of Sapphire Biotech.

Impairment Loss

For the year ended December 31, ~~2022~~2023 we recorded an impairment loss of $-0- as compared to $~~5,966,452~~-0- for the year ended December 31, ~~2021~~2022. ~~The company impaired it IPR&D and goodwill assets created on acquisition of Sapphire resulting from an FDA decision not to approve our COVID test.~~

Other Income and Expenses

Our interest expenses for the years ending ~~2022~~2023 and ~~2021~~2022 were $1,~~697~~028,~~455~~336 and $~~247~~1,~~792~~697,455, respectively. Loss on extinguishment of debt for the years ending in ~~2022~~2023 and ~~2021~~2022 were $~~479~~(162,~~573~~811) and $1479,~~587,027~~573 respectively, variance was result of debt exchange ~~and true-up adjustment for stock compensation.~~ Amortization of debt discount was $~~178~~176,~~962~~428 and $~~238~~178,~~033~~962 respectively. ~~Income~~Loss ~~grants~~on ~~from~~settlement ~~government~~of ~~for~~Litigation ~~the~~955,000 ~~year~~in ~~ending~~2023 ~~2022~~ and ~~2021~~zero ~~were~~in ~~$-0-~~2022. The ~~and~~company ~~$279,981,~~settled ~~respectively,~~a ~~and~~patent ~~the~~infringement ~~variance~~suit. ~~was~~during a2023 ~~result~~we ofpurchased ~~the~~equipment ~~termination~~by ofissuing ~~innovation~~shares ~~research~~at ~~grants~~a ~~from~~discount ~~NCI~~resulting in ~~2020~~a loss of $80,080.

For the Year Ended December 31, ~~2022~~2023 and ~~2021~~2022

Net Cash Provided by/Used in Operating Activities

Net cash used in ~~continuing~~ operating activities ~~and discontinued operating activities was~~ $21,~~044~~030,~~326 and $-0-~~500, respectively, for the twelve months ended December 31, ~~2022~~2023, as compared to net cash used of $2,~~478~~044,~~769 and $7,996~~ 326 for the twelve months ended December 31, ~~2021~~2022. The cash used in operating activities is primarily attributable to our net loss from operations of $68,~~242~~059,~~949~~682 and offset by net changes in the balances of operating assets and liabilities and non-cash expenses. For the twelve months ended December 31, ~~2022~~2023, stock-based compensation was $1197,~~107,494~~727 and amortization of debt discount was $~~178~~176,~~692~~428. For the twelve months ended December 31, ~~2021~~2022 these non-cash expenses were stock-based compensation of $1,~~143~~107,~~730~~494 and amortization of $~~238~~178,962. For the twelve months ended December 31, ~~2022~~2023 and ~~2021~~2022 the Company recorded increase to accounts payable and accrued expenses of $~~659~~769,~~400~~030 and $~~277~~659,~~507~~400, respectively, of ~~continuing~~ operating activities. The Company recorded for the twelve months ended December 31, ~~2022~~2023 and ~~2021~~2022 a loss on extinguishment of debt of $~~266~~(162,~~111~~811) and $1266,~~587~~111,~~027,~~ respectively. The Company recorded amortization of prepaid expenses for the twelve months ended December 31, ~~2022~~2023 and ~~2021~~2022 of $~~210~~42,~~094~~858 and $~~376~~210,~~936~~094 respectively. The Company recorded stock issued for services for the twelve months ended December 31, ~~2022~~2023 and ~~2021 of $79,500 and $1,888,391 respectively. The Company recorded impairment of intangible assets for the twelve months ended December 31,~~ 2022 ~~and 2021~~ of $~~394,446~~-0- and $279,~~087,908~~500 respectively.

~~The company recorded common stock issued for settlement of obligation for the twelve months ended December~~ 31, ~~2022~~Table ~~and 2021~~ of $226,172 and $-0- respectively. The Company recorded non cash interest expense for the twelve months ended December 31, 2022 and 2021 of $1,316,846 and $-0- respectively. The Company recorded change in fair value of derivative liabilities for the twelve months ended December 31, 2022 and 2021 of $765,556 and $-0- respectively. The Company recorded an increase in deferred revenue for the twelve months ended December 31, 2022 and 2021 of $333,125 and $-0- respectively. The Company recorded an increase in prepaid expenses for the twelve months ended December 31, 2022 and 2021 of $103,230 and $284,574 respectively. Contents

59The ~~Table~~company recorded common stock issued for settlement of ~~Contents~~obligation for the twelve months ended December 31, 2023 and 2022 of $-0- and $226,172 respectively. The Company recorded non cash interest expense for the twelve months ended December 31, 2023 and 2022 of $790,000 and $1,316,846 respectively. The Company recorded change in fair value of derivative liabilities for the twelve months ended December 31, 2023 and 2022 of $6,619 and $765,556 respectively. The Company recorded an increase in deferred revenue for the twelve months ended December 31, 2023 and 2022 of $(29,998) and $333,125 respectively. The Company recorded an increase in prepaid expenses for the twelve months ended December 31, 2023 and 2022 of $-0- and $103,230 respectively.

Net Cash provided by Investing Activities

Net cash used in (provided by) investing activities during the period ended December 31, ~~2022~~2023 was $~~8,710~~-0- compared to $508,~~495~~710 for the same period in ~~2021 due to acquisition of patents $10,000 and purchase of equipment of $40,495 in 2021.~~2022

Net Cash Provided by Financing Activities

Net cash provided by financing activities during the twelve months’ period ended December 31, ~~2022~~2023, was $1,~~647~~139,~~355,~~675 ~~including $0 used in discontinued financing activities,~~ compared to $21,~~533~~647,~~042~~355 for the same period in ~~2021~~2022. The Company has successfully raised significant capital in exchange for its common stock for the twelve months ended December 31, ~~2022~~2023. The company recorded proceeds from convertible note of $1675,~~325,~~000 in ~~2022~~2023 and $1,~~010~~325,000 in ~~2021~~2022. The Company repaid a convertible note at $1,243,200 in 2022.

Critical Accounting Policies

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amount of assets and liabilities, the disclosure of contingent assets and liabilities and the reported amounts of revenue and expenses during the reported periods. The more critical accounting estimates include estimates related to revenue recognition and accounts receivable allowances. We also have other key accounting policies, which involve the use of estimates, judgments and assumptions that are significant to understanding our results, which are described in Note 5 to our consolidated financial statements.

Our management’s discussion and analysis of financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements during the reporting periods. These items are monitored and analyzed by us for changes in facts and circumstances, and material changes in these estimates could occur in the future. We base our estimates on historical experience, known trends and events, and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Changes in estimates are reflected in reported results for the period in which they become known. Actual results may differ materially from these estimates under different assumptions or conditions.

Fair Value of Financial Instruments

Fair value is defined as the price that would be received to sell an asset, or paid to transfer a liability, in an orderly transaction between market participants. A fair value hierarchy has been established for valuation inputs that gives the highest priority to quoted prices in active markets for identical assets or liabilities and the lowest priority to unobservable inputs.

Research and Development Costs

Research and development costs are expensed as incurred. Research and development reimbursements and grants are recorded by us as a reduction of research and development cost.

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Share-Based Payments

We estimate the fair value of each stock option award at the grant date by using the Black-Scholes option pricing model. The fair value determined represents the cost for the award and is recognized over the vesting period during which an employee is required to provide service in exchange for the award. We account for forfeitures of stock options as they occur.

Income Taxes

We use the asset and liability method to calculate deferred taxes. Deferred taxes are recognized based on the differences between the financial reporting and income tax bases of assets and liabilities using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. We review deferred tax assets for a valuation allowance based upon whether it is more likely than not that the deferred tax asset will be fully realized. A valuation allowance, if necessary, is provided against deferred tax assets, based upon our assessment as to their realization.

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We recognize tax when the positions meet a “more-likely-than-not” recognition threshold. There were no tax positions for which it is considered reasonably possible that the total amounts of unrecognized tax benefits will significantly increase or decrease within the next year. We recognize interest related to unrecognized tax benefits in interest expense and penalties in operating expenses.

Recently Issued Accounting Standards

Note 5 to consolidated financial statements appearing elsewhere in this report includes Recently Issued Accounting Standards.

Foreign Currency Transactions

Foreign exchange gain (loss) in the year ended December 31, ~~2022~~2023, was $-0- compared to $~~(7,324)~~-0- for the same period in ~~2021~~2022. ~~All foreign currency gains (loss) were related to discontinued operations.~~

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Not applicable to a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K.

Item 8. Financial Statement and Supplementary Data

The full text of the Company’s consolidated financial statements for the fiscal years ended December 31, ~~2022~~2023 and ~~2021~~2022, begins on page F-1 of this Annual Report on Form 10-K.

Item 9. Changes In and Disagreements with Accountants on Accounting and Financial Disclosure

None.

Item 9A. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports filed pursuant to the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules, regulations and related forms, and that such information is accumulated and communicated to our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure.

As of December 31, ~~2022~~2023 we carried out an evaluation, under the supervision and with the participation of our principal executive officer and our principal financial officer of the effectiveness of the design and operation of our disclosure controls and procedures. Based on this evaluation, our principal executive officer and our principal financial officer concluded that our disclosure controls and procedures were effective as of the end of the period covered by this report.

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Management’s Annual Report on Internal Control over Financial Reporting

The Company’s management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in rule 13a-15(f) of the Exchange Act. The Company’s internal control system is designed to provide reasonable assurance to the Company’s management and Board of Directors regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP. The Company’s internal control over financial reporting includes those policies and procedures that:

	·	Pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the Company;

	·	Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company; and

	·	Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements.

These limitations preclude the board and management from having absolute assurance of the achievement of the entity’s objectives. Even an effective control system provides reasonable but not absolute assurances.

An evaluation was performed under the supervision and with the participation of the Company’s management of the effectiveness of the design and operation of the Company’s procedures and internal control over financial reporting as of December 31, ~~2022~~2023. In making this assessment, the Company used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control-Integrated Framework as updated as of 2017. Based on that evaluation, the Company’s management concluded that the Company’s internal controls over financial reporting were effective as of December 31, ~~2022~~2023. Management, board of directors, and other personnel use judgment every day to select, develop, and deploy controls across the Company. Management, among other personnel apply judgement as they monitor and assess the effectiveness of the system of internal control.

Attestation Report of the Registered Public Accounting Firm

This Annual Report on Form 10-K does not include an attestation report of our registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by the Company’s registered public accounting firm pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act, wherein non-accelerated filers are exempt from Sarbanes-Oxley internal control audit requirements.

Changes in Internal Control over Financial Reporting

The Company has formal Compensation, Audit, Nominating and Governance Committees. Management and the Board established controls over financial reporting through policies and procedures that help ensure that management’s directives to mitigate risks to the achievement of objectives are carried out. Control activities are performed at all levels of the entity, at various levels within day-to-day procedures, and over technology environment. The Company’s control over financial reporting includes combination of preventive and detective controls and encompass a range of manual and automated activities such as authorizations and approvals, verifications, reconciliations, and business performance reviews.

Inherent Limitations of Internal Controls

Internal control provides reasonable assurance of achieving entity’s objectives, limitations do exist. Internal control cannot prevent bad judgment or decisions, or external events that can cause the Company to fail to achieve its operational goals. However, even an effective system of internal control can experience a failure. The limitations include, but not limited to: suitability of objectives established as a precondition to internal control; reality that human judgment in decision making can be faulty and subject to bias; breakdowns that can occur because of human failures such as simple errors; ability of management to override internal control; ability of management, other personnel, and/or third parties to circumvent controls through collusion; external events beyond the organization’s control. Notwithstanding these inherent limitations, management is aware of them when selecting, developing, and deploying controls that minimize, to the extent practical, these limitations. Segregation of duties is built into the selection and development of control activities. Where segregation of duties is not practical, management selects and develops alternative control activities. Ongoing evaluations are built into business process at different hierarchy levels of the Company and provide timely information. Findings are evaluated against criteria established by regulations, recognized standard-setting bodies or management and the board of directors, and deficiencies are communicated to management and the board of directors as appropriate.

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Item 9B. Other Information

None.

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Not applicable.

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PART III

Item 10. Directors, Executive Officers and Corporate Governance

Directors, Executive Officers and Key Employees of AXIM

Our current executive officers, key employees and directors are listed in the below table. There are no arrangements, agreements or understandings between non-management security holders and management under which non-management security holders may directly or indirectly participate in or influence the management of our affairs. There are no arrangements or understandings between any director and any other person pursuant to which any director or executive officer was or is to be selected as a director or executive officer, as applicable. There currently are no legal proceedings, and during the past ten years there have been no legal proceedings, that are material to the evaluation of the ability or integrity of any of our directors or director nominees.

NAME	AGE	POSITION
John W. Huemoeller II	67	Chief Executive Officer, President
Catalina Valencia	74	CEO Sapphire Biotechnologies
Robert Malasek	5456	Chief Financial Officer, Secretary
Joseph Tauber, MD	66	Chief Medical Officer
Timothy R. Scott, PhD	70	Director
Robert Cunningham	75	Director
Peter O’Rourke	50	Director
Blake N. Schroeder	47	Director

The background of our executive officers, key employees and directors is as follows:

John W. Huemoeller II - Chief Executive Officer, President

Mr. Huemoeller was appointed as the Company’s Chief Executive Officer on January 2, 2019 and as a director on our Board of Directors since May 18, 2017. Mr. Mr. Huemoeller has over 30 years’ experience in financial markets and publicly traded companies including investment banking, corporate finance, executive management, sales and marketing, mergers and acquisitions, leveraged buyouts and private placements of securities. Since April 2015 to the present, Mr. Huemoeller has been the chief executive officer and president of Air Water Earth Inc. From March 2013 to January 2016, he was chairman, chief executive officer and chief financial officer of Propell Technologies Group Inc. From April 2012 to March 2013, Mr. Huemoeller served as the president of Joshua Tree Capital Inc. Mr. Huemoeller has held Series 3, 7, 24, 63 and 79 Securities Licenses, was registered with various state insurance boards, the Chicago Board of Trade as a commodities broker, and worked for various broker-dealers throughout his career including Smith Barney, Drexel Burnham, Prudential Securities, and Paine Webber. Mr. Huemoeller is co-author of U.S. Patent #5,855,005.

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Robert Malasek - Chief Financial Officer, Secretary

Mr. Malasek has served as the Company’s Chief Financial Officer since June 29, 2016. Mr. Malasek’s experience includes serving as the Assistant Controller for Starwood Hotel & Resorts Worldwide, Inc., Controller for Pacific Crest Equity Partners (a private equity company), and Chief Financial Officer for NatureWell, Inc. From 2011 to 2015, Robert served as the Chief Financial Officer, Secretary, Treasurer and a Director of Liberty Coal Energy Corp. Since 2015, Robert has served as the Chief Financial Officer of Cannalink, Inc. Robert received his Bachelor of Science in Accountancy from San Diego State University.

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Timothy R. Scott, PhD - Director

Dr. Scott has served as a director on our Board of Directors since May 18, 2017, and has also served on the Board of Directors of Medical Marijuana, Inc. from March 2015 to the present. From September 2001 to May 2008, Dr. Scott served on the board of directors of Naturewell, Incorporated, a publicly traded company engaged in the nutraceutical and homeopathic drug business. From 1998 to 2000, Dr. Scott served as a member of the board of directors of ICH Corporation, an American Stock Exchange listed company, which owned 265 fast food and family dining restaurants having approximately $265 million in revenues and 7,800 employees, and as a member of ICH’s compensation committee. Dr. Scott has served as chairman of the board of directors, president and senior pastor of a 2,500-member church located in San Diego, California from 1992 to the present. He also has served as chairman and president of Project Reach World, Inc., a 501(c)(3) charitable organization from 1995 to the present. He received his Ph.D. in Theology from Christian University in 1981 and served as a Professor of Philosophy and Religion at Pacific International College from 1981 to 1985.

Robert Cunningham - Director

Robert Cunningham has served as a Director since May 18, 2017. Mr. Cunningham has over 40 years of executive management in financial services and venture capital. From 1985 to the present Mr. Cunningham has been the Founder/CEO of Placer Financial, a nationwide mortgage and real estate development firm. He has served as Receiver/Trustee for the U.S. Department of Justice, and board member for numerous firms including Allied Commercial Corporation, Vermillion Development, Pacific Building Industries, and Bond Hospitality Group. From March 2015 to the present, Mr. Cunningham has served on the Board of Directors of Medical Marijuana, Inc.

Peter O’Rourke – Director

Mr. O’Rourke has served as a director on our Board of Directors since July 21, 2020. Mr. O’Rourke’s background includes holding leadership roles in management consulting, private equity, aerospace and operations companies. Mr. O’Rourke’s experience includes leadership in sales, marketing, operations, finance and performance improvement. In 2018, Mr. O’Rourke was appointed Acting Secretary of the U.S. Department of Veterans Affairs after serving as the Chief of Staff and Executive Director for the Office of Accountability and Whistleblower Protection. Before joining the Department of Veterans Affairs, Mr. O’Rourke honorably served as a U.S. Navy enlisted Airman and an Air Force Officer and Logistician. Mr. O’Rourke received a Bachelor of Arts in Political Science from the University of Tennessee in Knoxville as well as a Master of Science in Logistics and Supply Chain Management from the United States Air Force’s Institute of Technology.

Blake N. Schroeder

Mr. Schroeder has served as a director on our Board of Directors since January 6, 2022. Mr. Schroder began his career with a commercial litigation law firm in Salt Lake City, Utah. Beginning in 2008, Schroeder focused on the sale and marketing of natural products and opening international marketplaces to those products. From 2008 to 2014 Mr. Schroeder served in various capacities at MonaVie, LLC developing international business plans and growing international businesses. From August 2014 to February 2016, Mr. Schroeder served as the Chief Operating Officer of Forevergreen International, where he was responsible for global operation and sales of the multinational organization, including oversight of a global supply chain. From 2021 to the present, Mr. Schroeder has served as the Chief Executive Officer and Chairman of the Board of Medical Marijuana, Inc. From 2016 to the present, Mr. Schroeder serves as the chief executive officer of Kannaway USA, LLC, a wholly owned subsidiary of Medical Marijuana, Inc. Medical Marijuana, Inc. is one of the Company’s largest shareholders holding approximately 16.4% of the Company’s common stock, as of January 10, 2022. Mr. Schroeder holds a B.S. in Finance from Utah State University and a law degree from Syracuse University College of Law.

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Officers of Sapphire Biotech, Inc.

Catalina Valencia, J.D

Chief Executive Officer and Co-Founder - Sapphire Biotech, Inc.

Catalina specialized in leading enterprises to success through the strategic development of businesses and products. Her career focus has been on start-ups and small businesses in the biotech industry starting with Genentech. Early in her legal career, Catalina joined the Rio de Janeiro office of Cleary, Gottlieb, Steen & Hamilton as an Associate Attorney where she represented American companies seeking to enter into joint ventures with Brazilian enterprises. In the Bay Area, she was recruited by Itel, a Wall Street success story that declared a historic bankruptcy due to its size just one year after she joined the company. She successfully completed the disposition of over $1 Billion in executory contracts, enabling the company to emerge from bankruptcy. Subsequently, Catalina was recruited by Genentech, Inc., the premier biotech pioneer, during the company’s early start-up phase. Catalina’s accomplishments included structuring ventures which formed the basis for Genentech’s international expansion. Catalina has been the co-founder of several companies, most recently Sapphire Biotech, all with a mission to develop pioneering scientific technologies with life-saving potential. Catalina graduated Magna Cum Laude, Highest Department Honors, with a B.A. degree from UCLA and received her J.D. Degree from the University of California, Berkeley School of Law. Her scholastic achievements include an Alumni Scholarship to UCLA, Fellowship to Berkeley Law School, Teaching Fellowship to Stanford Law School and Fulbright Fellowship to Brazil.

Dr. Sergei A. Svarovsky, Ph.D, MBA

Chief Scientific Officer and Co-Founder - Sapphire Biotech, Inc.

Dr. Svarovsky is the scientific founder of Sapphire. He brings to the Company a breadth of experience and expertise from his academic, government and industry careers in the fields of medicinal chemistry and medical diagnostics. He has authored over 25 peer reviewed publications, reviews and book chapters, contributed to at least 20 international and U.S. patents and participated in over 50 international symposia. Some of his patents has been licensed by Pfizer, BioRad, among others. He serves on Editorial Boards of several international journals in the fields of chemistry, medical technology and nanotechnology and is a reviewer for a number of national and international funding organizations including National Science Foundation, National Institutes of Health, Israeli Science Foundation, and Georgian Science Foundations. Dr. Svarovsky obtained a PhD in Physical Organic Chemistry and MBA in Finance from University of West Virginia in 2000. Prior to entering the biopharma industry, Dr. Svarovsky served as a Postdoctoral Fellow at the Laboratory of Medicinal Chemistry at the National Cancer Institute. In 2006 he became an Associate Professor at the Biodesign Institute at Arizona State University where he met with another co-founder of Sapphire, Dr. Douglas Lake. Dr. Svarovsky joins Axim Biotechnologies, Inc. in the role of Chief Scientific Officer with a mission to develop novel therapeutics modalities and diagnostics for the treatment and detection of cancer.

Dr. Douglas Lake, Ph.D

Chief Clinical Officer - Sapphire Biotech, Inc.

Douglas Lake is a tumor immunologist who has been at ASU since 2006. Previously, he was at the University of Arizona Cancer Center where he studied anti-tumor T cells and tumor-associated peptides as immunotherapy targets. Currently, he is investigating an enzyme called QSOX1 that is over-expressed in multiple tumor types. Lake was the first to show that this enzyme is important in tumor cell growth, invasion and metastasis. His laboratory is developing chemical and biological inhibitors of QSOX1 with strong therapeutic potential. His laboratory also studies Valley Fever (Coccidioidomycosis). A pressing clinical need is that Valley Fever lacks an accurate and sensitive diagnostic test while patients are acutely symptomatic. Lake is developing a test that detects bits and pieces of the fungus in urine in infected patients. Lake’s research team also studies chimeric antigen receptor T cells (CAR T cells). This technology re-directs the immune system toward defined markers on tumors and unleashes T cells as the most potent killers against tumors. The vision for CAR T therapies is to re-activate patients’ immune systems against their tumors, such that they will have lifelong immunity against their tumor and any mutant tumors that might arise. In addition, Lake teaches immunology and microbiology at the undergraduate level and advance cell biology at the graduate level.

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Alim Seit-Nebi, Ph.D

Chief Technology Officer and Co-Founder - Sapphire Biotech, Inc.

Dr.Seit-Nebi leads the development and implementation of new antibody and protein-based technologies in diagnostics and therapeutics. Prior to joining Sapphire, Dr.Seit-Nebi was leading the development and production of antibodies, recombinant proteins, biomarkers, and immunoassays for diagnostic and therapeutic applications for industry and academia, serving at various roles at GenWay Biotech, Inc. for more than 11 years. Dr. Seit-Nebi is an expert in a broad array of biochemical, genetic, molecular, and cellular biology methods with detailed knowledge of signaling pathways in inflammation, oncogenesis, and cell stress response. He published 38 articles in prestigious peer-reviewed life-science journals. He received a doctorate degree in molecular biology from the Engelhardt Institute of Molecular Biology in Moscow, Russia, in 2002. He then pursued his research interests in immunology and molecular biology as a postdoctoral fellow at The Scripps Research Institute.

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Maria Moa, Ph.D

VP, Product Development - Sapphire Biotech, Inc.

Dr. Maria J. Gonzalez Moa is an NCI-trained Medicinal Chemist and as VP, Product Development, will be responsible for chemical synthesis, compound design, compound acquisition from outside sources, and assistance with molecular modeling and NMR. Dr. Moa holds a Ph.D in Organic/Physical Chemistry from the University of Vigo, Spain. At the University of Vigo, she was Postdoctoral Research Associate, Department of Organic and Physical Chemistry. Dr. Moa was a Postdoctoral Fellow in the Laboratory of Medicinal Chemistry at the National Cancer Institute, National Institutes of Health, Frederick, Maryland. Dr. Moa was Postdoctoral Research Associate at the Center for Innovations in Medicine, the Biodesign Institute, Arizona State University in Tempe, Arizona. She has extensive experience working with new tools for diagnostics and was in charge of the development of novel lateral flow assay tests for the rapid diagnostic of infectious diseases. Her experience in Medicinal Chemistry includes design, synthesis, and the computational study of small molecules with potential anticancer and antiviral activity. Dr. Moa has published and co-authored over 40 articles in peer-reviewed publications, reviews and book chapters.

Corporate Governance

General

We believe that good corporate governance is important to ensure that the Company is managed for the long-term benefit of our shareholders. This section describes key corporate governance practices that we have adopted.

Board of Directors Meetings and Attendance

The Company’s Board of Directors has responsibility for establishing broad corporate policies and reviewing our overall performance rather than day-to-day operations. The primary responsibility of the Board is to oversee the management of the Company and, in doing so, serve the best interests of the Company and its shareholders. The Board selects, evaluates and provides for the succession of executive officers and, subject to shareholder election, directors. It reviews and approves corporate objectives and strategies and evaluates significant policies and proposed major commitments of corporate resources. The Board also participates in decisions that have a potential major economic impact on the Company. Management keeps the directors informed of Company activity through regular communication, including written reports and presentations at Board and committee meetings.

Committees of the Board of Directors

The Company has formal Compensation, Audit and Nominating and Governance Committees. All other functions of the Board are being undertaken by the Board of Directors as a whole.

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Compensation Committee

The Compensation Committee consists of Timothy Scott, and Robert Cunningham and has established a charter that requires all members of the Compensation Committee to be “non-employee directors” for purposes of Rule 16b-3 of the Exchange Act and satisfy the requirements of an “outside director” for purposes of Section 16(m) of the Internal Revenue Code. The Compensation Committee is responsible for overseeing and, as appropriate, making recommendations to the Board of Directors regarding the annual salaries and other compensation of our executive officers, our general employee compensation and other policies and providing assistance and recommendations with respect to our compensation policies and practices. The Compensation Committee is authorized to carry out these activities and other actions reasonably related to the Compensation Committee’s purposes or assigned by the Board of Directors from time to time. The Compensation Committee’s specific responsibilities are delineated in its charter.

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Audit Committee

The Audit Committee consists of Robert Cunningham and Timothy Scott and has established a charter that requires all members of the Audit Committee to be independent in accordance with applicable listing standards. Our securities are quoted on the OTCQB, which does not have any director independence requirements. Further, companies with securities only quoted on the OTCQB are not required to comply with the independence standards set forth in Rule 10A-3(b)(1) of the Exchange Act. Our Board of Directors has determined that Mr. Robert Cunningham is an “audit committee financial expert” as defined in Item 407(d) of Regulation S-K.

The Audit Committees responsibilities include: (i) selecting and evaluating the performance of our independent auditors; (ii) reviewing the scope of the audit to be conducted by our independent auditors, as well as the result of their audit, and approving audit and non-audit services to be provided; (iii) reviewing and assessing our financial reporting activities and disclosure, including our earnings press releases and periodic reports, and the accounting standards and principles followed; (iv) reviewing the scope, adequacy and effectiveness of our internal control over financial reporting; (v) reviewing management’s assessment of our compliance with our disclosure controls and procedures; (vi) reviewing our public disclosure policies and procedures; g) reviewing our guidelines and policies regarding risk assessment and management, our tax strategy and our investment policy; h) reviewing and approving related-party transactions; and (vii) reviewing threatened or pending litigation matters and investigating matters brought to the committees attention that are within the scope of its duties.

Nominating and Governance Committee

The Nominating and Governance Committee consists of Robert Cunningham and Timothy Scott and has established a charter that governs its role with the Company. Timothy Scott has been appointed as the Chairman of the Nominating and Governance Committee.

The role of the Nominating and Governance Committee is to identify, qualify and propose new board members for the Company. The Nominating and Governance Committee shall also submit a slate of officers including, when applicable. The Nominating and Governance Committee shall: (i) obtain biographies and effectively screen all nominations to ensure selection of members of the highest caliber to serve as selected officers and directors; and (ii) in connection with the performance of its duties, the Nominating and Governance Committee shall have unrestricted access to and assistance from the officers, employees and independent auditors of the Corporation, and shall be furnished with such resources and support from the Company as the Nominating and Governance Committee shall deem necessary. The Nominating and Governance Committee shall have the authority to employ, at the expense of the Company, such experts and professionals as the Nominating and Governance Committee shall deem appropriate from time to time.

Security Holder Communications with our Board of Directors

The Company provides an informal process for security holders to send communications to our Board of Directors. Security holders who wish to contact the Board of Directors or any of its members may do so by writing to: AXIM Biotechnologies, Inc., 6191 Cornerstone Court E Suite 114 San Diego, CA 92121. Correspondence directed to an individual board member is referred, unopened, to that member. Correspondence not directed to a particular board member is referred, unopened, to the President and CEO.

Conflicts of Interest

Some officers and all our directors are not obligated to commit their full time and attention to our business and, accordingly, they may encounter a conflict of interest in allocating their time between our operations and those of other businesses. In the course of their other business activities, they may become aware of investment and business opportunities which may be appropriate for presentation to us as well as other entities to which they owe a fiduciary duty. As a result, they may have conflicts of interest in determining to which entity a particular business opportunity should be presented. They may be currently and, in the future, may become affiliated with entities that are engaged in business activities similar to those we intend to conduct.

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In general, officers and directors of a corporation are required to present business opportunities to the Company if:

1. The Company could financially undertake the opportunity;

2. The opportunity is within the Company’s line of business; and

3. It would be unfair to the Company and its shareholders not to bring the opportunity to the attention of the Company.

Code of Ethics

We have adopted a written code of ethics that obligates our directors, officers and employees to disclose potential conflicts of interest and prohibits those persons from engaging in such transactions without our consent.

Compliance with Section 16(a) of Securities Exchange Act of 1934

Section 16(a) of the Securities Exchange Act of 1934, as amended, requires the registrant’s officers and directors, and persons who own more than 10% of a registered class of the registrant’s equity securities, to file reports of ownership and changes in ownership of equity securities of the Registrant with the Securities and Exchange Commission. Officers, directors and greater-than-10% shareholders are required by the Securities and Exchange Commission regulation to furnish the registrant with copies of all Section 16(a) forms that they file. Based solely upon a review of Forms 3 and 4 and amendments thereto furnished to us during our most recent fiscal year and Forms 5 and amendments thereto furnished to us with respect to our most recent fiscal year, to the best of our knowledge, all executive officers, directors and persons holding greater than 10% of our issued and outstanding stock did not file the required reports in a timely manner during fiscal 2022.

Family Relationships

There is no family relationship between any Director, executive or person nominated or chosen by the Company to become a Director or executive officer.

Item 11. Executive Compensation

Summary Compensation Table

The following table sets forth the total compensation for services rendered in all capacities that was earned by each individual who served (i) as our principal executive officer at any time during fiscal ~~2022~~2023, and (ii) our two most highly compensated executive officers other than our principal executive officer who were serving as executive officers as of December 31, ~~2022~~2023:

Name and Principal Position	~~Year~~	Year	~~Salary~~	Salary		~~Bonus~~	Bonus		~~StockAwards~~	StockAwards		~~Warrant/OptionAwards~~	Warrant/OptionAwards		~~Non-EquityIncentivePlanCompensation~~	Non-EquityIncentivePlanCompensation		~~NonqualifiedDeferredCompensationEarnings~~	NonqualifiedDeferredCompensationEarnings		~~All OtherCompensation~~	All OtherCompensation		~~Total/$~~	Total/$
John W. Huemoeller II	~~2022~~	2023		~~420,000~~	420,000		-	-		-	-	~~5,000,000~~				-	-		-	-		-	-			420,000
Director, Chief Executive Officer	~~2021~~	2022		~~420,000~~	420,000		-	-		-	-			5,000,000		-	-		-	-		-	-		~~420,000~~	420,000
Catalina Valencia	~~2022~~	2023		~~187,500~~	187,500																					187,500
CEO Sapphire Biotechnologies	~~2021~~	2022		~~187,500~~	187,500																				~~187,500~~	187,500
Robert Malasek	~~2022~~	2023		~~90,000~~	90,000		-	-		-	-		~~500,000~~			-	-		-	-		-	-		~~90,000~~	90,000
Chief Financial Officer, Secretary	~~2021~~	2022		~~47,000~~	72,500		-	-		-	-		-	500,000		-	-		-	-		-	-		~~47,000~~	72,500

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Employment Agreements

John W. Huemoeller II

On January 2, 2019, the Company entered into an executive employment agreement, at a base salary of $20,000 per month, with John W. Huemoeller II to serve as its Chief Executive Officer. Pursuant to the agreement, Mr. Huemoeller’s employment shall at all times be “at will,” which means that he may resign at any time for any reason or for no reason, and that the Company may terminate his employment at any time for any reason or for no reason, in either case, subject to the applicable provisions of the agreement. In further consideration for Mr. Huemoeller’s services and subject to the approval of the Board, Mr. Huemoeller will be granted an option to purchase 2,000,000 shares of the Company’s common stock, upon his hiring (the “Option Shares”). The option will be subject to the terms and conditions applicable to stock options granted under the Company’s 2015 Stock Incentive Plan, as amended from time to time (the “Plan”), and as described in the Plan and the stock option agreement, which Mr. Huemoeller will be required to sign. 50% of the Option Shares shall vest on the date of grant and the remaining 50% of the Option Shares shall vest on the 12- month anniversary of the grant date, subject to Mr. Huemoeller’s continued employment by the Company. The exercise price per share will be equal to the fair market value per share on the date of grant, as determined by the last closing price of the Company’s common stock the day prior to grant. Beginning in October 2019, the Board of Directors decided to increase Mr. Huemoeller’s base salary to $35,000 per month.

Robert Malasek

On or about June 29, 2016, Robert Malasek was appointed as the Company’s Chief Financial Officer and Secretary. In April, 2017 the Company entered in employment agreement with Robert Malasek its, Chief Financial Officer and Secretary. The agreement does not have a set term and may be terminated by any time by the Company or Mr. Robert Malasek with proper notice. Under the agreement Mr. Malasek receives a monthly base compensation of $1,000 and effective April 1, 2022, Mr. Malasek’s base compensation was increased to $7,500 per month.

Outstanding Equity Awards at Fiscal Year-End ~~2022~~2023

Name	Number of Securities Underlying Unexercised Options (Exercisable)		Number of Securities Underlying Unexercised Options (Unexercisable)		Equity Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned Options		Option Exercise Price		Option Expiration Date

John W. Huemoeller II
		5,000,000					$	0.052	08/22/2032
Total

Robert Malasek		300,000		0		0	$	0.42	12/10/2030
		500,000						0.052	08/22/2032
Total

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Directors Compensation

The following table sets forth information for the year ended December 31, 2022, regarding the compensation awarded to, earned by, or paid to our non-employee directors who served on our board of directors during 2022.

70Director ~~Table~~Compensation offor ~~Contents~~Fiscal Year 2023

Name of Director	Fiscal Year	Fees earned or paid in cash ($)		Option Awards ($)	Stock Grants ($)		All other compensation ($)		Total ($)
Timothy R. Scott, PhD	2023		20,000			—		—		20,000
Robert Cunningham	2023		20,000			—		—		20,000
Peter O’ Rourke	2023		20,000			—		—		20,000
Blake N. Schroeder⁽¹⁾	2023		20,000							20,000
			0			—		—		0

Director Compensation for Fiscal Year 2022

Name of Director	FiscalYear	Fees earned orpaid in cash($)		OptionAwards($)		StockGrants($)		~~StockGrants($)~~		All other compensation($)		~~All other compensation($)~~		Total ($)		~~Total ($)~~
Timothy R. Scott, PhD	2022		20,000		~~51,990~~		—		—		—		—		20,000		~~71,990~~
Robert Cunningham	2022		20,000		~~51,990~~		—		—		—		—		20,000		~~71,990~~
Peter O’ Rourke	2022		20,000		~~51,990~~		—		—		—		—		20,000		~~71,990~~
Blake N. Schroeder(1)	2022		20,000		~~51,990~~										20,000		~~71,990~~
Mauricio J Gatto-Bellora(1)	2022		0				—		—		—		—		0		0

__________________

(1)

Mr. Gatto-Bellora resigned from his role on the Company’s Board of Directors on January 4, 2022. Mr. Blake Schroeder was appointed as a director of the Company on January 6, 2022, to fill the vacancy created by Mr. Bellora’s resignation.

For the year ended December 31, ~~2022~~2023, our directors were each entitled to receive an annual $20,000 cash stipend as compensation for their services as directors of the Company.

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Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

The following table sets forth certain information regarding our common stock beneficially owned as of April 15, ~~2023~~2024.

	(i)	each stockholder known by us to be the beneficial owner of five (5%) percent or more of our outstanding common stock;
	(ii)	each of our named executive officers and directors

71This ~~Table~~information as to beneficial ownership was furnished to the Company by or on behalf of ~~Contents~~each person named. As at April 16, 2024, there were 278,429,403 shares of our common stock issued and outstanding. Beneficial ownership is determined in accordance with the rules of the SEC, which generally attribute beneficial ownership of securities to persons who possess sole or shared voting or investment power with respect to those securities and for such persons includes shares of our common stock issuable to such persons pursuant to the exercise of stock options, warrants or other securities that are exercisable or convertible into shares of our common stock within 60 days of March 31, 2024.

This information as to beneficial ownership was furnished to the Company by or on behalf of each person named. As at April 15, 2023, there were 223,649,403 shares of our common stock issued and outstanding. Beneficial ownership is determined in accordance with the rules of the SEC, which generally attribute beneficial ownership of securities to persons who possess sole or shared voting or investment power with respect to those securities and for such persons includes shares of our common stock issuable to such persons pursuant to the exercise of stock options, warrants or other securities that are exercisable or convertible into shares of our common stock within 60 days of March 31, 2023.

	Name and Address of Beneficial Owner	(Stock)		(Options)		Amount and Nature of Beneficial Ownership		Percentage of Class
Named Executive Officers and Directors
	John W. Huemoeller II⁽¹⁾⁽⁴⁾		6,000,000		5,000,000		11,000,000		69	%

	Robert Malasek⁽¹⁾		50,000		800,000		850,000		5	%

	Timothy R. Scott, PhD⁽¹⁾		333,333		1,000,000		1,333,333		9	%
	Robert Cunningham⁽¹⁾		333,333		1,000,000		1,333,333		9	%
	Peter O’Rourke ⁽¹⁾		250,000		1,000,000		1,250,000		8	%

	All Directors and Officers as a Group		6,966,666		8,800,000		15,766,666		100

5% Stockholders
	Medical Marijuana, Inc.⁽²⁾		22,669,125
	Catalina Valencia		25,117,590
	Glycodots, LLC		19,800,000
	Juniper & Ivy Corporation⁽³⁾		500,000

	Name and Address ofBeneficial Owner	(Stock)		(Options)		Amount and Natureof Beneficial Ownership		Percentage of Class
Named Executive Officersand Directors
	John W. Huemoeller II(1)(4)		6,000,000		5,000,000		11,000,000
	Robert Malasek(1)		50,000		800,000		850,000
	Timothy R. Scott, PhD(1)		333,333		1,000,000		1,333,333
	Robert Cunningham(1)		333,333		1,000,000		1,333,333
	Peter O’Rourke (1)		250,000		1,000,000	1,250,000
	Blake N. Schroeder(1)		9,000		1,000,000		1,009,000
	All Directors and Officers as a Group
5% Stockholders
	Medical Marijuana, Inc.(2)		22,669,125
	Catalina Valencia		25,117,590
	Glycodots, LLC		19,800,000
	Juniper & Ivy Corporation(3)		500,000

________________

	* Less than 1%

	(1)	The address is: 6191 Cornerstone Court, E. Suite 114, San Diego, CA 92121.

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	(2)	The address is: 2384 La Mirada Drive, Vista, CA 92081

	(3)	Juniper & Ivy Corporation owns 500,000 shares of our Series C Preferred Stock. Each share of our Series C Preferred Stock in convertible into one (1) share of our common stock. The holder of our Series C Preferred Stock has voting control of the Company.

	(4)	Does not include 500,000 shares of Series C Preferred Stock held by Juniper & Ivy Corporation of which Mr. Huemoeller II is the sole shareholder.

Board of Directors Independence

The Company considers Robert Cunningham and Timothy Scott to be “independent” within the meaning of definitions established by the Securities and Exchange Commission.

Item 14. Principal Accountant Fees and Services

Audit Fees

RBSM LLP has served as our independent public accounting firm since 2014. RBSM LLP billed us $~~137~~178,~~171~~500 and $~~116~~137,~~703~~171 in audit fees during the years ended December 31, ~~2022~~2023 and ~~2021~~2022, respectively.

Audit-Related Fees

We did not pay any fees to any of our primary auditors, for assurance and related services that are not reported under Audit Fees above, during our fiscal years ended December 31, ~~2022~~2023 and ~~2021~~2022.

Tax and All Other Fees

We did not pay any fees to any of our primary auditors for tax compliance, tax advice, tax planning or other work during our fiscal years ended December 31, ~~2022~~2023 and ~~2021~~2022.

Pre-Approval Policies and Procedures

With respect to the audit of our financial statements as of December 31, ~~2022~~2023 and ~~2021~~2022, and for the years then ended, none of the hours expended on any of our primary auditor’s engagement to audit those financial statements were attributed to work by persons other than our primary auditor’s full- time, permanent employees.

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Item 15. Exhibits, Financial Statement Schedules

Please see the below Exhibit Index and the Index to Financial Statements and related notes to financials which follows the signature page to this annual report on Form 10-K and which is incorporated by reference herein.

Exhibit Index

Exhibits	Exhibit #	Incorporated by Reference (Form Type)	Filing Date	Filed with This Report

Articles of Incorporation, as filed with the Nevada Secretary of State on November 18, 2010.	3.1	10-Q	11/14/2014

Certificate of Amendment, as filed with the Nevada Secretary of State on July 24, 2014.	3.2	10-Q	11/14/2014

Amended and Restated (As of August 17, 2016) Bylaws of AXIM Biotechnologies, Inc.	3.3	10-Q	8/22/2016

Certificate of Designation of Series B Preferred Stock.	3.4	10-Q	8/22/2016

Certificate of Designation of Series C Preferred Stock.	3.5	10-Q	8/22/2016

Description of Securities	4.1			X

Letter of Intent (“Terms Sheet”) dated September 3, 2018, by and between Impression Healthcare Limited and AXIM Biotechnologies, Inc.	10.1	10-K (A/1)	10/30/2019

Exclusivity Agreement dated September 3, 2018, by and between Impression Healthcare Limited and AXIM Biotechnologies, Inc.	10.2	10-K (A/1)	10/30/2019

Amendment #1 to Exclusivity Agreement dated December 11, 2018, by and between Impression Healthcare Limited and AXIM Biotechnologies, Inc.	10.3	10-K (A/1)	10/30/2019

Supply Agreement dated May 31, 2019, by and between Impression Healthcare Limited and AXIM Biotechnologies, Inc.	10.4	10-K (A/1)	10/30/2019

May 1, 2019, License Agreement with CanChew Biotechnologies, LLC.	10.5	10-K (A/1)	05/20/2020

Equity Purchase Agreement dated May 14, 2021, by and between AXIM Biotechnologies, Inc and Cross & Company	10.6	8-K	05/14/2021

Binding Term Sheet Agreement dated August 3, 2021, by and between AXIM Biotechnologies, Inc. and Advanced Tear Diagnostics, LLC.	10.7	10-K	04/15/2022

Asset Purchase Agreement dated August 26, 2021, by and between AXIM Biotechnologies, Inc. and Advanced Tear Diagnostics, LLC.	10.8	10-K	04/15/2022

Form of 1.5% Short Term Promissory Notes, dated February 10, 2022.	10.9	8-K	02/16/2022

Form of 3% Short Term Promissory Notes, dated February 10, 2022.	10.10	8-K	02/16/2022

6% Convertible Redeemable Note dated September 29, 2021, made by and between AXIM Biotechnologies, Inc. and GS Capital Partners, LLC, as amended.	10.11	8-K	02/16/2022

Termination Agreement dated March 3, 2022, by and between AXIM Biotechnologies, Inc. and Empowered Diagnostics, LLC	10.12	10-K	04/15/2022

7445 Table of Contents

Code of Business Conduct and Ethics.	14.1	10-Q	11/20/2017

Subsidiaries	21.1			X

Consent of Independent Registered Public Accounting Firm	23.1			X

Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.	31.1			X

Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.	31.2			X

Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.	32.1			X

Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.	32.2			X

Nominating and Governance Committee Charter.	99.1	10-Q	11/20/2017

Compensation Committee Charter.	99.2	10-Q	11/20/2017

Audit Committee Charter.	99.3	10-Q	11/20/2017

XBRL Instance Document	101.INS			X

XBRL Taxonomy Extension Schema Document	101.SCH			X

XBRL Taxonomy Extension Calculation Linkbase Document	101.CAL			X

XBRL Taxonomy Extension Definition Linkbase Document	101.DEF			X

XBRL Taxonomy Extension Label Linkbase Document	101.LAB			X

XBRL Taxonomy Extension Presentation Linkbase Document	101.PRE			X

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Signature	Title	Date
/s/ John W. Huemoeller II	President and Director (Principal Executive Officer)	April 1716, ~~2023~~2024
John W. Huemoeller II
/s/ Robert Malasek	Chief Financial Officer (Principal Financial Officer)	April 1716, ~~2023~~2024
Robert Malasek
/s/ Timothy R. Scott, PhD	Director	April 1716, ~~2023~~2024
Timothy R. Scott, PhD
/s/ Robert Cunningham	Director	April 1716, ~~2023~~2024
Robert Cunningham
/s/ Peter O’Rourke	Director	April 1716, ~~2023~~2024
Peter O’ Rourke
/s/ Blake N. Schroeder	Director	April 1716, ~~2023~~2024
Blake N. Schroeder

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AXIM BIOTECHNOLOGIES, INC.

Index to Financial Statements

Report of Independent Registered Public Accounting Firm		F-2
Consolidated Balance Sheet as of December 31, 2022 and 2021		F-5
Consolidated Balance Sheet as of December 31, 2023 and 2022		F-4
Consolidated Statements of Operations for the years ended December 31, 2022 and 2021		F-6
Consolidated Statements of Operations for the years ended December 31, 2023 and 2022		F-5
Consolidated Statement of Changes in Shareholders’ Deficit for years ended December 31, 2022 and 2021		F-7
Consolidated Statement of Changes in Shareholders’ Deficit for years ended December 31, 2023 and 2022		F-6
Consolidated Statement of Cash Flows for the years ended December 31, 2022 and 2021		F-8
Consolidated Statement of Cash Flows for the years ended December 31, 2023 and 2022		F-7
Notes to Consolidated Financial Statements.		F-98

F-1 Table of Contents

New York Office:

805 Third Avenue

New York, NY 10022

212.838-5100

www.rbsmllp.com

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Shareholders of

Axim Biotechnologies, Inc.

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of Axim Biotechnologies, Inc. (the “Company”), as of December 31, ~~2022~~2023 and ~~2021~~2022, and the related consolidated statements of operations, stockholders’ deficit and cash flows for each of the two years in the period ended December 31, ~~2022~~2023 and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, ~~2022~~2023 and ~~2021~~2022, and the results of its operations and its cash flows for each of the two years in the period ended December 31, ~~2022~~2023, in conformity with accounting principles generally accepted in the United States of America.

The Company’s Ability to Continue as a Going Concern

The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. As discussed in Note 54 to the accompanying consolidated financial statements, the Company has suffered recurring losses from operations, generated negative cash flows from operating activities, has an accumulated deficit that raise substantial doubt about Company’s ability to continue as a going concern. Management’s evaluation of the events and conditions and management’s plans in regarding these matters are also described in Note 54. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Basis for Opinion

These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The company is not required to have, nor were we engaged to perform, an audit of the Company’s internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

New York, NY Washington DC Las Vegas, NV, San Francisco, CA Athens, GRE Beijing, CHN Mumbai, and Pune IND

Member ANTEA INTERNATIONAL with offices worldwide

F-2 Table of Contents

Critical Audit Matters

The critical audit matters communicated below are matters arising from the current period audit of the carve-out financial statements that were communicated or required to be communicated to the audit committee and that (i) relate to accounts or disclosures that are material to the carve-out financial statements and (ii) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the carve-out financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.

New York, NY Washington DC Mumbai & Pune, India Boca Raton, FL

San Francisco, CA Las Vegas, NV Beijing, China Athens, Greece

Member: ANTEA International with affiliated offices worldwide

F-2

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Recoverability of intangible assets (Note 5)

Description of the Matter

As described in Note 5 to the consolidated financial statements, the Company has patents having a carrying value of $~~221~~199,~~124~~657 and 510(K) Licenses having a value of $3,~~768~~395,~~303~~324. There are definite life intangible assets. The Company assesses potential impairments whenever events or circumstances indicate that the asset may be impaired. For finite-lived intangible assets the impairment is based on recoverability.

Recoverability of an asset group is measured by a comparison of the carrying amount of an asset group to its forecasted cash flows expected to be generated by the asset group. If the carrying amount of the asset group exceeds its estimated forecasted cash flows, an impairment charge is recognized as the amount by which the carrying amount of the asset group exceeds the fair value of the asset group. The Company did not recognize an impairment loss in the financial statements for the year ended December 31, ~~2022~~2023.

We identified the evaluation of intangible asset impairment as a critical audit matter because the determination of the forecasted individual asset group’s cash flows requires a high degree of auditor judgment and increased extent of effort. The significant assumptions used to estimate the recoverability of the intangible assets included certain assumptions that form the basis of the forecasted results, including revenue growth rates and expected net operating income margins. These significant assumptions are forward looking and could be affected by future economic and market conditions.

New York, NY Washington DC Las Vegas, NV, San Francisco, CA Athens, GRE Beijing, CHN Mumbai, and Pune IND

Member ANTEA INTERNATIONAL with offices worldwide

F-3 Table of Contents

How We Addressed the Matter in Our Audit

Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included the following:

·i. Inquiry of management regarding the development of the assumptions used in the asset group cash flows of the intangible assets. ·ii. Testing management’s process included evaluating the appropriateness of the group cash flow models, and testing the reasonableness of significant assumptions, including the income projections. ·iii. Involvement of our professionals with specialized skill and knowledge were used to assist in evaluating the reasonableness of significant assumptions. ·iv. Evaluated the experience, qualifications and objectivity of the Company’s specialist, a third-party valuation firm. ·v. Obtained an understanding of the nature of the work the Company’s specialist performed, including the objectives and scope of the specialist’s work; and the methods or assumptions used. Identified and evaluated assumptions developed by the specialist considering assumptions generally used in the specialist’s field; supporting evidence provided by the specialist.

/s/ RBSM, LLP

We have served as the Company’s auditor since 2014

PCAOB ID 587

New York, New York

April 1716, ~~2023~~2024

New York, NY Washington DC ~~Las Vegas, NV,~~ ~~San~~Mumbai ~~Francisco,~~& ~~CA Athens~~Pune, ~~GRE~~India ~~Beijing,~~Boca ~~CHN Mumbai~~Raton, ~~and Pune IND~~ FL

~~Member~~San ~~ANTEA~~Francisco, ~~INTERNATIONAL~~CA Las ~~with~~Vegas, ~~offices~~NV Beijing, ~~worldwide~~China Athens, Greece

~~F-4~~Member: ~~Table~~ANTEA ofInternational ~~Contents~~with affiliated offices worldwide

F-3

Table of Contents

AXIM BIOTECHNOLOGIES, INC.

CONSOLIDATED BALANCE SHEETS

	31-Dec-22			31-Dec-21
	December 31,			December 31,
	2023			2022
ASSETS
Current assets:
Cash	$	47156,~~282~~457		$	~~452~~47,~~963~~282
Prepaid expenses		~~42,858~~-			~~163~~42,~~561~~858
Other current assets		~~13,839~~			2013,~~089~~839
Total current assets		~~103~~156,~~979~~457			~~636~~103,~~613~~979
Property and equipment, net of accumulated depreciation		93134,~~840~~067			~~116~~93,~~810~~840
Other assets:
Other Assets:
Notes receivable- related party		-			~~104,268~~-
Intangible asset , net		3,989,427			4,383,873
Intangible Asset 510k License and Patents-Eye Care Division, net		3,594,981			3,989,427
Security deposit		59,~~000~~014			5,000
Operating lease right-of-use asset		19227,~~789~~029			7619,~~871~~789
Total other assets		43,~~014~~831,~~216~~024			4,~~570~~014,~~012~~216
TOTAL ASSETS	$	4,~~212~~121,~~035~~548		$	54,~~323~~212,~~435~~035
LIABILITIES AND STOCKHOLDERS’ DEFICIT
LIABILITIES AND STOCKHOLDERS' DEFICIT
Current liabilities:
Accounts payable and accrued liabilities	$	12,~~316~~781,~~248~~068		$	~~909~~1,~~458~~316,248
Lease liability obligations (see Note 17)		19,789			56,871
Lease liability obligations (see Note 16) current portion		94,829			19,789
Due to shareholder		-			180
Due to first insurance funding		-			26,781
Due to first insurance funding		26,781			32,873
due to related parties		21,500			-
Promissory note (including accrued interest of $-0- and $40,475, respectively) (see note 9)		-			454,693
Advances from shareholders		295,170			47,720
Advances from shareholder		47,720			-
Deferred revenue		303,127			333,125
Convertible note payable (including accrued interest of $0 and $16,919, respectively) (see note 11)					1,126,919
Derivative liability conversion feature		2,482,723			1,648,831
Deferred revenue		333,125			-
Total current liabilities		5,978,417			3,392,494
Derivative liability conversion feature		1,648,831			-
Total current liabilities		3,392,494			2,580,994
Long-term liabilities:
Convertible note payable (including accrued interest of $274,442 and $192,765, respectively) net of unamortized debt discount of $1,583,435 and $605,640, respectively (see note 11)		1,383,416			761,604
Convertible note payable (including accrued interest of $76,163 and $274,442 respectively) net of unamortized debt discount of $1,209,806 and $1,583,435, respectively (see note 11)		1,408,766			1,383,416
Convertible note payable - related party (including accrued interest of $261,537 and $299,037, respectively) (see note 11)		4,261,537			4,299,037
Convertible note payable - related parties (including accrued interest of $160,091 and $261,537, respectively) (Net of unamortized debt discount of $631,123 and $-0-, respectively See note 11)		4,253,968			4,261,537
Lease liability obligations (see Note 17)		-			20,000
Lease liability obligations (see Note 16)		137,044			-
Total long-term liabilities		5,~~644~~799,~~953~~778			5,~~080~~644,~~641~~953
TOTAL LIABILITIES		911,~~037~~778,~~447~~195			79,~~661~~037,~~635~~447
STOCKHOLDERS’ DEFICIT
STOCKHOLDERS' DEFICIT
Preferred stock, $0.0001 par value, 5,000,000 shares authorized;
Series B Convertible Preferred Stock, $0.0001 par value 500,000 shares designated, 500,000 and 500,000 shares issued, 0 and 0 outstanding, respectively		-			-
Series C Convertible Preferred Stock, $0.0001 par value 500,000 shares designated, 500,000 and 500,000 shares issued and outstanding, respectively		50			50
Common stock, $0.0001 par value, 300,000,000 shares authorized 192,441,917 and 138,099,981 shares issued and outstanding, respectively		19,245			13,811
Common stock, $0.0001 par value, 1,000,000,000 shares authorized 245,929,403 and 192,441,917 shares issued and outstanding, respectively		24,593			19,245
Stock subscription receivable		(4624,~~000~~475	)		-(46,000	)
Additional paid in capital		5964,~~191~~528,~~469~~043			5159,~~000~~191,~~166~~469
Common stock to be issued		~~135,000~~0			4135,~~530,~~000
Accumulated deficit		(6472,~~125~~184,~~176~~858	)		(5764,~~882~~125,~~227~~176	)
TOTAL STOCKHOLDERS’ DEFICIT		(4,825,412	)		(2,338,200	)
TOTAL STOCKHOLDERS' DEFICIT		(7,656,647	)		(4,825,412	)
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT	$	4,212,035		$	5,323,435
TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT	$	4,121,548		$	4,212,035

See accompanying notes to these consolidated financial statements

F-4

Table of Contents

AXIM BIOTECHNOLOGIES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS

	For the			For the
	Year Ended			Year Ended
	December 31,			December 31,
	2023			2022

Revenues	$	39,518		$	8,875

Operating Expenses:
Research and development expenses		125,496			153,697
Selling, general and administrative		2,237,842			4,081,824
Depreciation and amortization		427,019			426,126
Total operating expenses		2,790,357			4,661,647

Loss from operations		(2,750,839	)		(4,652,772	)

Other (income) expenses:
Interest income		-			(257	)
Loss on issuance of shares for Equipment		80,080
Loss on settlement of litigation		955,000			-
Derivative liability insufficient shares		3,238,429			-
Gain on change in value of derivative liability		(6,619	)		(765,556	)
Loss on extinguishment/conversion of debt		(162,811	)		479,573
Amortization of note discount		176,428			178,962
Interest expense		1,028,336			1,697,455
Total other expenses		5,308,843			1,590,177

Loss before provision of income tax		(8,059,682	)		(6,242,949	)
Provision for income tax		-			-

Loss from operations		(8,059,682	)		(6,242,949	)

NET LOSS	$	(8,059,682	)	$	(6,242,949	)

Earnings per share
Basic	$	(0.04	)	$	(0.04	)
Diluted	$	(0.04	)	$	(0.04	)

Weighted average common shares outstanding - basic and diluted		227,691,452			165,468,263

See accompanying notes to these consolidated financial statements

F-5

Table of Contents

AXIM BIOTECHNOLOGIES, INC.

CONSOLIDATED ~~STATEMENTS~~STATEMENT OF ~~OPERATIONS~~STOCKHOLDERS' DEFICIT

	For the			For the
	Common Stock						Preferred Stock			Series A ConvertiblePreferred Stock			Series B ConvertiblePreferred Stock			Series C ConvertiblePreferred Stock				Common Stock to be			Additional Paid In			Stock			Accumulated
	Year Ended			Year Ended
	Shares#			Amount $			Shares#	Amount $		Shares#	Amount $		Shares#	Amount $		Shares#		Amount$		Issued$			Capital $			SubscriptionReceivable			Deficit $			Total $
	31-Dec-22			31-Dec-21
Balance at December 31, 2021		138,099,981			13,811				-		$	-			-		500,000		50		4,530,000			51,000,166						(57,882,227	)		(2,338,200	)
Revenues	$	8,875		$	60,460
common stock issued under s-1		20,977,638			2,098																			1,331,168			(46,000	)					1,287,266
Operating Expenses:
common stock issued against common stock to be issued for purchase of atd		7,000,000			700																(4,270,000	)		4,269,300									-
Research and development expenses		153,697			284,869
Common stock issued against common stock to be issued		166,667			17																(25,000	)		24,983									-
Selling, general and administrative		4,081,824			5,668,450
common stock issued stock purchase agreements		14,837,874			1,484																			453,516									455,000
Depreciation and amortization		426,126			2,115,687
common stock issued for services		802,115			80																(100,000	)		179,420									79,500
Impairment Loss		-			5,966,452
cashless exercise stock options		282,759			28																			(28	)
Total operating expenses from continuing operations		4,661,647			14,035,458
stock issued on settlement of debt		173,390			17																			32,927									32,944
Gain (Loss) from continuing operations		(4,652,772	)		(13,974,998	)
Stock based compensation - stock options																								1,107,492									1,107,492
Other (income) expenses:
stock issued on settlement of debt		891,610			89																			64,107									64,196
Interest income		(257	)		(1,026	)
stock issued settlement of claim		3,544,247			354																			225,817									226,171
Income from grants from government		-			(279,981	)
Loss on extinguishment of debt																								154,292									154,292
Gain on change in value of derivative liability		(765,556	)		-
Stock issued on settlement of debt		5,665,636			567																			348,309									348,876
Loss on extinguishment/conversion of debt		479,573			1,587,027
Net Loss																														(6,242,949	)		(6,242,949	)
Amortization of note discount		178,962			238,033
Balance December 31, 2022		192,441,917			19,245												500,000		50		135,000			59,191,469			(46,000	)		(64,125,176	)		(4,825,412	)
Financing costs		-			257,466
Common stock issued against common stock to be issued		1,000,000			100																(135,000	)		134,900									-
Interest expense		1,697,455			247,792
Shares issued extinguishment of debt Beneficial conversion payment of interest		22,207,486			2,220																			686,212									688,432
Total other (income) expenses		1,590,177			2,049,311
Debt modifications / conversions																								459,522									459,522
Loss before provision of income tax		(6,242,949	)		(16,024,309	)
Common stock issued under s-1		23,000,000			2,300																			467,631			21,525						491,456
Provision for income tax		-			-
Stock based compensation- stock options																								197,728									197,728
Loss from continuing operations		(6,242,949	)		(16,024,309	)
Satisfaction of Short Share liability																								3,238,429									3,238,429
Loss from discontinued operations		-			(7,996	)
Common Stock issued stock purchase agreement		7,280,000			728																			152,152									152,880
NET INCOME (LOSS)	$	(6,242,949	)	$	(16,032,305	)
Net Loss																														(8,059,682	)		(8,059,682	)
NET LOSS ATTRIBUTABLE TO COMMON SHAREHOLDERS	$	(6,242,949	)	$	(16,032,305	)
Balance December 31, 2023		245,929,403			24,593												500,000		50		0			64,528,043			(24,475	)		(72,184,858	)		(7,656,647	)
Earnings per share from continuing operations
Basic	$	(0.04	)	$	(0.12	)
Diluted	$	(0.04	)	$	(0.12	)
Earnings per share from discontinued operations
Basic	$	(0.00	)	$	(0.00	)
Diluted	$	(0.00	)	$	(0.00	)
Earnings per share
Basic	$	(0.04	)	$	(0.12	)
Diluted	$	(0.04	)	$	(0.12	)
Weighted average common shares outstanding - basic and diluted		165,468,263			131,539,920

See accompanying notes to these consolidated financial statements

F-6

Table of Contents

AXIM BIOTECHNOLOGIES, INC.

AXIM BIOTECHNOLOGIES, INC.
Consolidated Statements of Cash Flows

	For the			For the
	Year Ended			Year Ended
	December 31,			December 31,
	2023			2022
CASH FLOWS FROM OPERATING ACTIVITIES:
Net Loss		(8,059,682	)		(6,242,949	)
Depreciation		32,573			31,680
Derivative Liability insufficient Shares		3,238,429
Stock based compensation		197,727			1,107,494
Amortization of prepaid expenses		42,858			210,094
Amortization of debt discount		176,428			178,962
Amortization of deferred rent		(1,211	)		-
Common Stock issued for services/equipment		80,080			79,500
Amortization (Impairment) of intangible assets		394,446			394,446
Loss (gain) on extinguishment of debt		(162,811	)		266,111
Loss on conversion of convertible debt					11,068
Common stock issued in settlement of an obligation					226,172
Severance cost note receivable waived					102,387
Non cash interest expense		790,000			1,316,846
Change in fair value of derivative		(6,619	)		(765,556	)
Amortization Of Debt Issuance Cost
Loss on settlement of litigation		955,000			-
Changes in operating assets & liabilities:
Increase in due to related parties		21,500			-
Increase (decrease) in other assets		9,825			1,701
Increase in shareholder advances		521,925			47,720
Increase in due to first insurance funding					80,614
(Increase) decrease in prepaid expenses					(103,230	)
Increase (decrease) in accounts payable and accrued expenses		769,030			659,400
Increase in deferred revenue		(29,998	)		333,125
(Increase) decrease in inventory					20,089

Net cash provided by (used in) operating activities		(1,030,500	)		(2,044,326	)
CASH FLOW FROM INVESTING ACTIVITIES:

Increase in property and equipment		-			(8,710	)
Net cash provided by (used in) investing activities		-			(8,710	)

CASH FLOW FROM FINANCING ACTIVITIES:
Proceeds from convertible note		675,000			1,325,000
Common stock issued under registration statement on Form S-1		491,456			1,287,261
Repayment of convertible notes					(1,243,200	)
Repayment of promissory note		-			(90,000	)
Common stock issued under share purchase agreement		-			455,000
Repayment of first insurance funding		(26,781	)		(86,706	)
Net cash provided by (used in) financing activities		1,139,675			1,647,355
Net increase (decrease) in cash and cash equivalents		109,175			(405,681	)
Cash and cash equivalents at beginning of year		47,282			452,963
Cash and cash equivalents at end of year	$	156,457			47,282

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
CASH PAID DURING THE PERIOD FOR:
Interest	$	-			177,500
Income taxes - net of tax refund	$	-		$	-
NON-CASH INVESTING AND FINANCING ACTIVITIES
Common stock issued against common stock to be issued	$	135,000		$	125,000
Initial derivative liability at issuance of notes	$	1,465,000		$	2,641,846
Common stock issued against CS subscription	$	23,475		$	46,000
Common stock issued for severance				$	64,197
Common Stock issued against settlement of debt	$	250,000		$	237,057
Promissory note refinanced against convertible note				$	367,931
Common Stock issued against Common stock to be issued for Acquisition				$	4,270,000
Right of use assets and liabilities	$	270,087
Convertible note converted to common stock	$	669,044
Accrued interest converted to Common Stock	$	30,859		$	32,944
Common stock issued on asset purchase	$	152,880
Reversal of derivative liability on short shares	$	3,238,430
Initial debt discount at issuance of notes	$	459,522

~~CONSOLIDATED~~See ~~STATEMENT~~accompanying OFnotes ~~STOCKHOLDERS’~~to ~~DEICIT~~these consolidated financial statements

	Common Stock				Preferred Stock				Series A ConvertiblePreferred Stock				Series B ConvertiblePreferred Stock				Series C ConvertiblePreferred Stock				Common Stock to be			Additional Paid In			Stock Subscription			Accumulated
	Shares		Amount		Shares		Amount		Shares		Amount		Shares		Amount		Shares		Amount		Issued			Capital			Receivable			Deficit			Total
	#		$		#		$		#		$		#		$		#		$		$			$			$			$			$
Balance at December 31, 2020		125,327,579		12,533		-		-		-		-		-		-		500,000		50		201,974			43,201,186						(41,849,922	)		1,565,821
Common stock to be issued for Note receivable and True-up adjustment
Common stock issued against common stock to be issued received in PY		108,965		11																		(66,974	)		66,963									0
Common stock issued for severance payable of discontinued operation		379,463		38																					224,963									225,001
Convertible note and accrued interest converted to common stock		4,372,903		438																					1,220,682									1,221,120
Common stock issued for cash against S-1 agreement		762,400		76																					358,461									358,537
Loss on extinguishment of debt																									1,587,027									1,587,027
Common stock to be issued for asset acquisition																						4,270,000												4,270,000
Common stock issued for cash		4,304,328		430																					1,251,570									1,252,000
Common stock issued for services		2,529,905		253																					1,888,150									1,888,403
Common stock issued for financing cost		118,000		12																					57,454									57,466
Common stock issued on cashless option exercise		196,438		20																					(20	)								0
Common stock to be Issued for cash																						25,000												25,000
Common stock to be issued for services																						100,000												100,000
Stock based compensation options																									1,143,730									1,143,730
Net loss																															(16,032,305	)		(16,032,305	)
Balance at December 31, 2021		138,099,981		13,811				-			$	-				-		500,000		50		4,530,000			51,000,166						(57,882,227	)		(2,338,200	)
Common stock issued under S-1		20,977,638		2,098																					1,331,168			(46,000	)					1,287,266
Common stock issued against common stock to be issued for purchase of atd		7,000,000		700																		(4,270,000	)		4,269,300									-
Common stock issued against common stock to be issued		166,667		17																		(25,000	)		24,983									-
Common stock issued stock purchase agreements		14,837,874		1,484																					453,516									455,000
Common stock issued for services		802,115		80																		(100,000	)		179,420									79,500
Cashless exercise stock options		282,759		28																					(28	)
Stock issued on settlement of debt		173,390		17																					32,927									32,944
Stock based compensation - stock options																									1,107,492									1,107,492
Stock issued on settlement of debt		891,610		89																					64,107									64,196
Stock issued settlement of claim		3,544,247		354																					225,817									226,171
Loss on extinguishment of debt																									154,292									154,292
Stock issued on settlement of debt		5,665,636		567																					348,309									348,876
																																		-
Net Loss																															(6,242,949	)		(6,242,949	)
Balance December 31, 2022		192,441,917		19,245														500,000		50		135,000			59,191,469			(46,000	)		(64,125,176	)		(4,825,412	)

F-7

Table of Contents

AXIM BIOTECHNOLOGIES, INC.

Consolidated Statements of Cash Flows

	For the			For the
	Year Ended			Year Ended
	December 31,			December 31,
	2022			2021
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(6,242,949	)	$	(16,032,305	)
Less: Loss from discontinued operations		0			(7,996	)
Loss from continuing operations		(6,242,949	)		(16,024,309	)
Adjustments to reconcile net loss to cash used in operating activities:
Depreciation		31,680			27,779
Stock based compensation		1,107,494			1,143,730
Amortization of prepaid expenses		210,094			376,936
Amortization of debt discount		178,962			238,033
Common stock issued for financing cost		-			57,466
Common stock to be issued for services		-			100,000
Common stock issued for services		79,500			1,888,391
Amortization (Impairment) of intangible assets		394,446			2,087,908
Loss on extinguishment of debt		266,111			1,587,027
Loss on conversion of convertible debt		11,068			-
Common stock issued in settlement of an obligation		226,172			-
Severance cost note receivable waived		102,387			-
Non cash interest expense		1,316,846			-
Change in fair value of derivative		(765,556	)		-
Amortization of debt issuance cost		-			100,000
Loss on impairment of intangible assets		-			5,966,452
Changes in operating assets & liabilities:
Increase (decrease) in interest receivable		1,701			(1,026	)
Increase in advance taken		47,720			-
Increase in due to first insurance funding		80,614			-
(Increase) decrease in prepaid expenses		(103,230	)		(284,574	)
Increase (decrease) in accounts payable and accrued expenses		659,400			277,507
Increase in deferred revenue		333,125			-
(Increase) decrease in inventory		20,089			(20,089	)
Net cash provided by (used in) operating activities from continuing operations		(2,044,326	)		(2,478,769	)
Net cash provided by (used in) operating activities from discontinued operations		-			(7,996	)
Net cash provided by (used in) operating activities		(2,044,326	)		(2,486,765	)
CASH FLOW FROM INVESTING ACTIVITIES:
Acquisition of Patents		-			(10,000	)
Increase in property and equipment		(8,710	)		(40,495	)
Net cash provided by (used in) investing activities from continuing operations		(8,710	)		(50,495	)
Net cash provided by (used in) investing activities from discontinued operations		-			-
Net cash provided by (used in) investing activities		(8,710	)		(50,495	)
CASH FLOW FROM FINANCING ACTIVITIES:
Proceeds From Convertible Note		1,325,000			1,010,000
Common stock issued under registration statement on Form S-3		1,287,261
Repayment of convertible notes		(1,243,200	)
Repayment of promissory note		(90,000	)		(120,000	)
Proceeds from Common Stock under S-1		-			358,538
Proceeds from Common stock to be issued under Stock Purchase agreement		-			25,000
Common stock issued under share purchase agreement		455,000			1,252,000
Repayment of first insurance funding		(86,706	)		7,504
Net cash provided by (used in) continuing financing activities		1,647,355			2,533,042
Net cash provided by (used in) discontinued financing activities
Net cash provided by (used in) financing activities		1,647,355			2,533,042
Net increase (decrease) in cash and cash equivalents		(405,681	)		(4,218	)
Cash and cash equivalents at beginning of year		452,963			457,181
Cash and cash equivalents at end of year	$	47,282		$	452,963
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
CASH PAID DURING THE PERIOD FOR:
Interest	$	177,500		$	-
Income taxes - net of tax refund	$	-		$	-
NON-CASH INVESTING AND FINANCING ACTIVITIES
Common stock issued against common stock to be issued	$	125,000		$	66,974
Initial derivative liability at issuance of notes	$	2,641,846		$	-
Common stock issued against CS subscription	$	46,000		$	-
Common stock issued for severance	$	64,197		$	225,000
Common Stock issued against settlement of debt	$	237,057		$	-
Promissory note refinanced against convertible note	$	367,931		$	-
Common Stock issued against Common stock to be issued for acquisition	$	4,270,000		$	-
Convertible note converted to common stock	$	-		$	1,221,119
Accrued interest converted to common Stock	$	32,944		$	-
Common stock issued on cashless exercise of options	$	28		$	20
Acquisition Of patents against notes payable and accounts payable	$	-		$	240,000
Common stock to be issued for acquisition	$	-		$	4,270,000

The accompanying notes are an integral part of these consolidated financial statements.

F-8 Table of Contents

AXIM BIOTECHNOLOGIES, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, ~~2022~~2023 AND ~~2021~~2022

NOTE 1: ORGANIZATION

The Company was originally incorporated in Nevada on November 18, 2010, as Axim International Inc. On July 24, 2014, the Company changed its name to AXIM Biotechnologies, Inc. to better reflect its business operations. The Company’s principal executive office is located at 6191 Cornerstone Court E suite 114 San Diego Ca 92121. On August 7, 2014, the Company formed a wholly owned Nevada subsidiary named Axim Holdings, Inc. This subsidiary will be used to help facilitate the anticipated activities planned by the Company. On May 11, 2015 the Company acquired a 100% interest in CanChew License Company a Nevada incorporated licensing Company, through the exchange of 5,826,706 shares of its common stock. In October 2017 the company formed a wholly owned subsidiary in the Netherlands for purposes of holding pharmaceutical licenses as required by the Netherlands regulations and laws. On October 16, 2018, the Company formed a wholly owned disregarded entity Marina Street, LLC as part of improvement of internal control over cash management and bank activities.

On March 17, 2020, the Company acquired Sapphire Biotech, Inc., (“Sapphire’) which is research and Development Company that has a mission to improve global cancer care through the development of proprietary therapeutics for inhibiting cancer growth and metastasis. Sapphire is also developing a line of novel diagnostics for early cancer detection, response to treatment, and recurrence monitoring. Additionally, with the onset of the COVID-19 pandemic, the Company decided to begin creating COVID-19 rapid diagnostic tools, including multiple first-in-class COVID-19 neutralizing antibody tests and other innovations.

Sapphire’s operations are located in the Greater San Diego Area.

~~COVID~~Russia-19Ukraine and Israeli-Hamas wars impact and related risks

The ongoing ~~global~~wars ~~outbreak~~in ~~of COVID~~Russia-~~19,~~Ukraine and ~~the~~Israeli-Hamas ~~various~~conflict ~~attempts~~could ~~throughout~~impact ~~the~~global ~~world~~supply ~~to contain it, have created significant volatility, uncertainty and disruption~~chains. InThis ~~response~~could toimpact ~~government~~business ~~directives~~operations ~~and~~by ~~guidelines,~~effecting ~~health care advisories and employee and other concerns, A number of~~ the ~~Company~~company’s ~~employees~~ability ~~have had~~ to ~~work~~procure ~~remotely~~necessary ~~from~~supplies ~~home~~ and ~~those on site have had to follow the Company’s social distance guidelines, which could impact their productivity~~equipment. ~~COVID-19~~This could ~~also~~possibly ~~disrupt~~interrupt the ~~Company’s~~continuing ~~operations~~sale ~~due to absenteeism by infected or ill members~~ of ~~management~~tests orwhich ~~other~~would ~~employees,~~eliminate ~~or absenteeism by members of management and other employees who cannot effectively work remotely but who elect not to come to work due to~~ the ~~illness affecting others in the Company~~company’s ~~office~~only orsource ~~laboratory~~of ~~facilities, or due to quarantines~~revenue.

~~Because~~In ofaddition ~~COVID-19,~~to ~~certain~~operational ~~travel~~adjustments, ~~visits,~~the ~~and~~consequences ~~in-person~~of ~~meetings~~the ~~related~~Russia-Ukraine toand ~~The~~Israeli- ~~Company’s~~Hamas ~~business~~conflicts have ~~been~~led ~~severely~~to ~~curtailed~~uncertainties orrelated ~~canceled~~to ~~and~~The ~~the~~ Company’s ~~has~~business ~~instead~~growth ~~used~~and ~~on-line~~ability orto ~~virtual~~forecast ~~meetings~~the todemand ~~meet~~for ~~with~~its ~~potential~~diagnostic ~~customers~~testing and ~~others~~resulting revenues.

InThe ~~addition~~full extent to ~~operational~~which ~~adjustments,~~ the ~~consequences~~Russia-Ukraine ofand ~~the COVID~~Israeli-19 ~~pandemic~~Hamas ~~have~~conflicts ~~led~~and tothe ~~uncertainties~~various ~~related~~responses to it might impact The Company’s business, ~~growth~~operations and ~~ability~~financial toresults ~~forecast~~will ~~the~~depend ~~demand~~on ~~for~~numerous ~~its~~evolving ~~diagnostic~~factors ~~testing~~that are not subject to accurate prediction and ~~resulting~~that ~~revenues.~~are beyond The Company’s control.

~~The~~In ~~full~~addition ~~extent to which~~ the ~~COVID-19~~impact ~~pandemic~~of ~~and~~inflation on the ~~various~~companies ~~responses~~ability to itpurchase ~~might~~supplies ~~impact The Company’s business, operations~~ and ~~financial~~manufacture ~~results~~products ~~will~~in ~~depend~~a oncost ~~numerous~~effective ~~evolving~~manner ~~factors~~is ~~that~~currently ~~are not subject to accurate prediction and that are beyond The Company’s control~~unknown.

~~Changes~~In toDecember 2019, a novel strain of coronavirus (“COVID-19”) was reported in Wuhan, China. The COVID-19 pandemic, as it was declared by the ~~Company~~World Health Organization, has continued to spread and has already caused severe global disruptions. The extent of COVID-19’s ~~Board~~effect on our operational and financial performance will depend on future developments, including the duration, spread and intensity of ~~Directors~~the pandemic, all of which are uncertain and difficult to predict considering the rapidly evolving landscape.

OnWe ~~January~~expect 4COVID-19, ~~2022~~along with the resulting government-imposed restrictions on businesses, ~~Mauricio~~to ~~Gatto~~negatively ~~Bellora~~impact ~~tendered~~our ~~his~~operations ~~resignation~~due asto adecreased ~~member~~consumer ofdemand ~~the~~as ~~Company’s~~well ~~Board~~as ofpotential ~~Directors,~~production and ~~the~~warehouse ~~Company~~limitations onwhich ~~that~~results ~~date~~in ~~accepted~~an ~~his~~event ~~resignation.~~or ~~Mr.~~condition, ~~Bellora’s~~before ~~decision~~consideration toof ~~resign~~management’s ~~was~~plans, ~~not~~that ~~the~~could ~~result~~impact ofour ~~any~~ability ~~disagreement~~to ~~with~~meet ~~the~~future ~~Company~~obligations.

F-9 Table of Contents

NOTE 1: ORGANIZATION (CONTINUED)

On January 6, 2022, the record holder of 500,000 shares of the Company’s Series C Preferred Stock, representing 100% of the 500,000 shares of Series C Preferred Stock issued and outstanding, which shares are entitled to cast a vote for election of up to four Series C Directors, whether by shareholder meeting (annual or special) or by written consent, acting pursuant to Section 78.320 of the Nevada Revised Statutes and Article III, Section 3 of the Company’s Amended and Restated Bylaws, consented by written consent in lieu of a meeting appointing Blake N. Schroeder to fill the director seat vacated by the resignation of Mauricio Javier Gatto Bellora.

Mr. Blake N. Schroeder, 42, began his career with a commercial litigation law firm in Salt Lake City, Utah. Beginning in 2008, Schroeder focused on the sale and marketing of natural products and opening international marketplaces to those products. From 2008 to 2014 Mr. Schroeder served in various capacities at MonaVie, LLC developing international business plans and growing international businesses. From August 2014 to February 2016, Mr. Schroeder served as the Chief Operating Officer of for evergreen International, where he was responsible for global operation and sales of the multinational organization, including oversight of a global supply chain. From 2021 to the present, Mr. Schroeder has served as the Chief Executive Officer and Chairman of the Board of Medical Marijuana, Inc. From 2016 to the present, Mr. Schroeder serves as the chief executive officer of Kannaway USA, LLC, a wholly owned subsidiary of Medical Marijuana, Inc. Medical Marijuana, Inc. is one of the Company’s largest shareholders holding approximately 16.4% of the Company’s common stock, as of January 10, 2022. Mr. Schroeder holds a B.S. in Finance from Utah State University and a law degree from Syracuse University College of Law.

Changes in the Business

On March 7, 2022, the Company announced that is has shifted its focus for its rapid COVID-19 Neutralizing Antibody (“Nab”)(NAb) Test to become For Research Use Only (“RUO”). The test will provide researchers an important tool for COVID-19 research and is not intended for use in diagnostic procedures. The Company has also entered a separation agreement with Empowered Diagnostics, LLC following the FDA recall of Empowered’s products, including the NabNAb test.

NOTE 2: ACQUISITION OF INTELLECTUAL PROPERTY OF ADVANCED TEAR DIAGNOSTIC, LLC.

AXIM entered into two substantially contemporaneous transactions to acquire patents and 510(K) Licenses from Advance Tear Diagnostics, LLC (the “Seller”) (collectively, the “Asset Acquisition”) for a total amount of $4,520,000.

The first transaction occurred on July 29, 2021, in which AXIM purchased five patents (the “Patents”) from the Seller for $250,000 (which includes assuming and paying $30,000 of the Seller’s liabilities). The bulk of the purchase price ($210,000) was in a note that requires seven equal monthly payments of $30,000, which payment started on September 3, 2021.

F-8

Table of Contents

The second transaction occurred on August 26, 2021, in which AXIM purchased certain eye disease diagnostic technology, which consisted of a 510(K) license for Lactoferrin, a biomarker for dry eye disease and a 510(K) license for IgE, a biomarker for allergic ocular reaction (collectively, the “510(K) Licenses”). The purchase price for the 510(K) Licenses was $4,270,000, which price was paid by issuing to the Seller 7 million shares of AXIM restricted common stock.

Together, the Patents and the 510(K) Licenses constitute the acquired technology asset (the “Technology Asset”), which for accounting purposes, are considered one unit of account. We are amortizing the Technology Asset ratably over the 119.541 years average remaining life of the Patents. The net value of these intangibles as of December 31, 2023 is $3,594,981.

F-10 Table of Contents

NOTE 2: ACQUISITION OF INTELLECTUAL PROPERTY OF ADVANCED TEAR DIAGNOSTIC, LLC. (CONTINUED)

In accordance with FASB’s requirements for accounting for business combinations (FASB Accounting Standards Codification, Topic 805, Business Combinations (“Topic 805”)), since all of the value of this acquisition resides in one asset, the Technology Asset, we have accounted for this transaction as the acquisition of an asset. The seller had not been able to commercialize or complete development of the Technology Asset prior to the asset acquisition and AXIM has established an Ophthalmology Division to commercialize and market the diagnostic technology. In an asset acquisition, the total purchase price of the transaction, including transaction expenses, is allocated to the assets acquired based on the fair value of the assets acquired. In our acquisition of the Technology Asset, the total amount of the purchase price was allocated to the Technology Asset.

NOTE 3: BASIS OF PRESENTATION:

The consolidated financial statements of AXIM Biotechnologies, Inc. (formerly Axim International, Inc.) as of December 31, ~~2022~~2023, and ~~2021~~2022 have been prepared in accordance with United States generally accepted accounting principles (“US GAAP”).

Principles of Consolidation

The consolidated financial statements include the accounts of Axim Biotechnologies, Inc. and its wholly owned subsidiaries Axim Holdings, Inc., Marina Street LLC, Axim Biotechnologies (the Netherland Company) and Sapphire Biotech, Inc. The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant inter-company balances and transactions have been eliminated upon consolidation.

NOTE 4: GOING CONCERN

The Company’s consolidated financial statements have been presented assuming that the Company will continue as a going concern. As shown in the consolidated financial statements, the Company has negative working capital of $35,~~288~~821,~~515~~960 and has an accumulated deficit of $6472,~~125~~184,~~176~~858, has cash used in operating activities of ~~continuing~~ operations $21,~~044~~030,~~326~~500. During the year ended December 31, ~~2022~~2023 and ~~2021~~2022, the Company raised additional capital of $172,~~742,261~~800 and $1455,~~610,537~~000 through Stock Purchase Agreements. This capital provides funds for research, development, and ongoing operations. The Company intends to raise substantial additional capital through private placements of debt and equity securities, but there can be no assurance that these funds will be available on terms acceptable to the Company or will be sufficient to enable the Company to fully complete its development activities or sustain operations. If the Company is unable to raise sufficient additional funds, it will have to develop and implement a plan to further extend payables, reduce overhead, or scale back its current business plan until sufficient additional capital is raised to support further operations. There can be no assurance that such a plan will be successful. That will raise a doubt about the ability of the Company to continue as a going concern. The consolidated financial statements do not include any adjustments related to the recoverability of assets and classification of liabilities that might be necessary should the Company be unable to continue in operation.

F-9

Table of Contents

NOTE 5: SIGNIFICANT ACCOUNTING POLICIES

Use of estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements as well as the reported amounts of revenue and expenses during reporting periods. Actual results could differ from these estimates. Significant estimates are assumptions about collection of accounts receivable, useful life of intangible assets, impairment analysis, derivative liability and assumptions used in Black-Scholes-Merton, or BSM, valuation methods, such as expected volatility, risk-free interest rate and expected dividend rate, for leases weighted number of life and discount rate.

F-11 Table of Contents

NOTE 5: SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

Operating lease

We lease property under various operating leases which are disclosed on our Balance sheet in accordance with ASC 842.

Risks and uncertainties

The Company operates in a dynamic and highly competitive industry and is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, protection of proprietary technology, dependence on key personnel, contract manufacturer and contract research organizations, compliance with government regulations and the need to obtain additional financing to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical studies and clinical trials and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance and reporting. The Company believes that changes in any of the following areas could have a material adverse effect on the Company’s future financial position, results of operations, or cash flows; ability to obtain future financing; advances and trends in new technologies and industry standards; results of clinical trials; regulatory approval and market acceptance of the Company’s products; development of sales channels; certain strategic relationships; litigation or claims against the Company based on intellectual property, patent, product, regulatory, or other factors; and the Company’s ability to attract and retain employees necessary to support its growth.

Products developed by the Company require approvals from the U.S. Food and Drug Administration (“FDA”) or other international regulatory agencies prior to commercial sales. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained or maintained, that the products will receive the necessary approvals, or that any approved products will be commercially viable. If the Company was denied approval, approval was delayed or the Company was unable to maintain approval, it could have a materially adverse impact on the Company. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate revenue from product sales. The Company operates in an environment of rapid change in technology and substantial competition from other pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees, consultants and other third parties.

Beginning in late 2019, the outbreak of a novel strain of virus named SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), or coronavirus, which causes coronavirus disease 2019, or COVID-19, has evolved into a global pandemic. The extent of the impact of the coronavirus outbreak on the Company’s business will depend on certain developments, including the duration and spread of the outbreak and the extent and severity of the impact on the Company’s clinical trial activities, research activities and suppliers, all of which are uncertain and cannot be predicted. At this point, the extent to which the coronavirus outbreak may materially impact the Company’s financial condition, liquidity or results of operations is uncertain. The Company has expended and will continue to expend substantial funds to complete the research, development and clinical testing of product candidates. The Company also will be required to expend additional funds to establish commercial-scale manufacturing arrangements and to provide for the marketing and distribution of products that receive regulatory approval. The Company may require additional funds to commercialize its products. The Company is unable to entirely fund these efforts with its current financial resources. If adequate funds are unavailable on a timely basis from operations or additional sources of financing, the Company may have to delay, reduce the scope of or eliminate one or more of its research or development programs which would materially and adversely affect its business, financial condition and operations.

There have been no material changes in the accounting policies from those disclosed in the financial statements and the related notes included in the Form 10-K.

F-1210 Table of Contents

NOTE 5: SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

Cash equivalents

The Company considers all highly liquid investments with original maturities of three months or less at the time of purchase to be cash equivalents. As of December 31, 2023 and 2022, the Company had no cash equivalents. Cash and cash equivalents are maintained at financial institutions and, at times, balances may exceed federally insured limits. The Company had no uninsured balances at December 31, 2023 and 2022. The Company has never experienced any losses related to these balances.

Accounts Receivable

It is the Company’s policy to review accounts receivable at least on a monthly basis for conductibility and follow up with customers accordingly. Covid19 has slowed collection as our customers are in a mandated pause. We do not have geographic concentration of customers.

Concentrations

At December 31, ~~2022~~2023, there was no accounts receivable. For the year ended December 31, ~~2022~~2023, one customer accounted for 100% of total revenue. For the year ended December 31, ~~2021~~2022 one customer accounted for 100% customer accounted. Revenue was all generated from normal operations for the twelve months ending December 31, ~~2022~~2023 and ~~2021~~2022.

Property and equipment

Property and equipment are carried at cost less accumulated depreciation. Depreciation is computed using straight-line method over the estimated useful life. New assets and expenditures that extend the useful life of property or equipment are capitalized and depreciated. Expenditures for ordinary repairs and maintenance are charged to operations as incurred. The Company’s property and equipment relating to ~~continuing~~ operations consisted of the following at December 31, ~~2022~~2023 and ~~2021~~2022, respectively~~, and none related to discontinued operations~~.

	December 31,2022		December 31,2021
	December 31,2023		December 31,2022
Equipment of continuing operations	$	183,992	$	175,283
Equipment of operations	$	256,792	$	183,992
Less: accumulated depreciation		90122,~~152~~725		5890,~~473~~152
	$	93134,~~840~~067	$	~~116~~93,~~810~~840

Depreciation expense was $3132,~~680~~573 and $2731,~~778~~680 for the years ended December 31, ~~2022~~2023 and ~~2021~~2022, respectively.

The company purchased fixed assets with a book value of $72,800 by issuing 17,280,000 share of stock with a market value of $152,880 recognizing a current loss of $80,080.

F-11

Table of Contents

Intangible Assets

Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired in each business combination. We conduct an impairment analysis for goodwill annually in the fourth quarter or more frequently if indicators of impairment exist or if a decision is made to sell or exit a business. Significant judgments are involved in determining if an indicator of impairment has occurred. Such indicators may include deterioration in general economic conditions, negative developments in equity and credit markets, adverse changes in the markets in which an entity operates, increases in input costs that have a negative effect on earnings and cash flows, or a trend of negative or declining cash flows over multiple periods, among others. The fair value that could be realized in an actual transaction may differ from that used to evaluate the impairment of goodwill. There is no goodwill balance as of December 31, 2023 or December 31, 2022.

We first may assess qualitative factors to determine if it is more likely than not that the fair value of a reporting unit is less than its carrying amount as a basis for determining whether it is necessary to perform the quantitative goodwill impairment test included in U.S. GAAP. To the extent our assessment identifies adverse conditions, or if we elect to bypass the qualitative assessment, goodwill is tested using a quantitative impairment test.

F-13 Table of Contents

NOTE 5: SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

Impairment of Indefinite-Lived Intangible Assets

For indefinite-lived intangible assets such as in-process research and development (IPRD), we conduct an impairment analysis annually in the fourth quarter or more frequently if indicators of impairment exist. We first perform a qualitative assessment to determine if it is more likely than not that the carrying amount of each of the in-process research and development assets exceeds its fair value. The qualitative assessment requires the consideration of factors such as recent market transactions, macroeconomic conditions, and changes in projected future cash flows. If we determine it is more likely than not that the fair value is less than its carrying amount of the in-process research and development assets, a quantitative assessment is performed. The quantitative assessment compares the fair value of the in-process research and development assets to its carrying amount. If the carrying amount exceeds its fair value, an impairment loss is recognized for the excess. There is no Indefinite-Lived Intangible Assets balance as of December 31, 2023.

~~We elected to perform a quantitative assessment of indefinite~~Long-~~lived~~Lived intangible assets and determined that the fair value of the goodwill and IPRD related to the Sapphire acquisition was less than its carrying amount and that in-process research and development were fully impaired.Assets

The Company’s regularly reviews the carrying value and estimated lives of all of its long-lived assets, including property and equipment and definite-lived intangible assets, ~~relating~~to determine whether indicators of impairment exist that warrant adjustments to ~~continuing~~carrying values or estimated useful lives. The determinants used for this evaluation include management’s estimate of the asset’s ability to generate positive income from operations and ~~discontinued~~positive ~~operations~~cash ~~consisted~~flow in future periods as well as the strategic significance of the ~~following~~assets atto ~~December~~the 31Company’s business objectives. If the Company determines that events or changes in circumstances indicate that the carrying amount of the asset group may not be recoverable, ~~2022~~the Company evaluates the realizability of its long-lived assets (asset group) based on a comparison of projected undiscounted cash flows from use and ~~2021,~~eventual ~~respectively:~~disposition with the carrying value of the related asset. Any write-downs (which are measured based on the difference between the fair value and the carrying value of the asset) are treated as permanent reductions in the carrying amount of the assets (asset group).

	December 31,		December 31,
	2022		2021
Patents	$	250,000	$	250,000
Licenses		4,270,000		4,270,000
		4,520,000		4,520,000
Less: accumulated amortization		530,573		136,127
	$	3,989,427	$	4,383,873

As at December 31, 2023, none of the Company’s long-lived assets were deemed impaired.

The Company’s intangible assets relating to operations consisted of the following at December 31, 2023 and 2022, respectively:

	December 31,		December 31,
	2023		2022
Patents	$	250,000	$	250,000
Licenses		4,270,000		4,270,000
		4,520,000		4,520,000
Less: accumulated amortization		925,019		530,573
	$	3,594,981	$	3,989,427

Estimated aggregate amortization expense for each of the five succeeding years ending December 31 is as follows:

	2023		2024		2025		2026		2027		2028 and onwards
	2024		2025		2026		2027		2028		2029 and onwards
Amortization expense	$	391,230	$	391,230	$	391,230	$	391,230	$	391,230	$	21,~~033~~638,~~277~~831

Amortization expense recorded for the years ended December 31, ~~2022~~2023 and ~~2021~~2022 was $394,446 and $2394,~~087,908~~446; respectively.

~~Goodwill~~F-12 ~~and~~Table ~~Intangible assets were impaired resulting in a net impairment loss in 2021~~ of ~~$5,966,452, resulting from an FDA decision not to approve our COVID test. This impairment was not recorded until December 31, 2021.~~Contents

Revenue Recognition

The Company follows the guidance contained in Topic 606 (FASB ASC 606). The core principle of Topic 606 (FASB ASC 606) is that an entity should recognize revenue to depict the transfer of goods of services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The revenue recognition guidance contained in Topic 606, to follow the five-step revenue recognition model along with other guidance impacted by this standard: (1) identify the contract with the customer; (2) identify the performance obligations in the contract; (3) determine the transportation price; (4) allocate the transportation price; (5) recognize revenue when or as the entity satisfies a performance obligation. All revenue was from operations that were divested.

F-14 Table of Contents

NOTE 5: SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

obligations in the contract; (3) determine the transportation price; (4) allocate the transportation price; (5) recognize revenue when or as the entity satisfies a performance obligation. All revenue was from operations that were divested.

Revenues are recognized when title for goods is transferred; non-refundable fees and proceeds from irrevocable agreements recognized when inflows or other enhancements of assets of the Company are received.

Revenues from ~~continuing~~ operations recognized for twelve months ended December 31, ~~2022~~2023 and ~~2021~~2022 amounted to $839,~~875~~518 and $608,~~460~~875, respectively. ~~Revenues from discontinued operations recognized for twelve months ended December 31, 2022 and 2021 amounted to $0 and $0, respectively.~~

Collaboration Revenue

Revenue recognition for collaboration agreements will require significant judgment. The Company’s assessments and estimates are based on contractual terms, historical experience and general industry practice. Revisions in these values or estimations have the effect of increasing or decreasing collaboration revenue in the period of revision.

On August 21, 2020, the Company entered into a Distribution, License and Supply Agreement (“License Agreement”) with Empowered Diagnostics, LLC (“Empowered Diagnostics”“). The License Agreement provides Empowered Diagnostics with a right to commercialize ~~The~~the ~~company~~Company’s products worldwide with the exception of Mexico.

Under the License Agreement, the ~~company~~Company is responsible for applying for and obtaining necessary regulatory approvals in the US and EU, as well as marketing, sales and distribution of the products. Empowered Diagnostics will pay a transfer price for all licensed products, and upon achievement of certain regulatory and sales milestones, the Company may receive payments from Empowered Diagnostics equal to 8% of the monthly gross revenue. Agreement continues until terminated by mutual consent or uncorrected breach.

This agreement with Empowered Diagnostics was terminated in February, 2022. The Company did not recognize any revenue from this agreement,.

Grant Income

In 2021 the Company has received government grants to drive its research and development efforts. Through these government grants, the government has provided funding for the Company to perform research and development activities which will assist in developing its products. The Company believes the government entities funding these grants are interested in the Company advancing its underlying technologies through research activities and not providing incentives for hiring employees or building facilities that would suggest that the grant monies are not for specific research activities. These grants were not renewed and are no longer in effect.

In determining how to classify the monies received under government grants, the Company acknowledges that there is no specific guidance under US GAAP and that the FASB and AICPA have often drawn upon the guidance in IAS 20 for classification. In considering the alternatives provided by IAS 20 for the presentation of these grants in the Company’s financial statements, the Company believes that recognizing the government grant proceeds as a component of other revenue is a better reflection of the economics of the arrangements as the Company earns the funding through the performance of research and development which is not one of the Company’s primary business activities or central to its operations. The Company believes that presenting research and development funding from government grants, as other revenue provides consistency in our financial reporting. The Company also believes that this presentation clearly presents to users of its financial statements in one line the Company’s sources of funding from these grants. The Company notes that there are no contingencies associated with the receipt of or ability to retain the funds under the grant, other than undertaking and performing the related research and development activities.

~~The~~F-13 ~~Company~~Table recognizes funds received from contractual research and development services and from government grants as other revenue. These contracts and grants are not considered an ongoing major and central operation of ~~the Company’s business. Our Income from Grants from Government for the years ended December 31, 2022 and 2021, was $-0- and $279,981 respectively.~~Contents

~~F-15~~The ~~Table~~Company recognizes funds received from contractual research and development services and from government grants as other revenue. These contracts and grants are not considered an ongoing major and central operation of ~~Contents~~the Company’s business. Our Income from Grants from Government for the years ended December 31, 2023 and 2022, was $-0- and $-0- respectively.

NOTE 5: SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

Cost of Sales

Cost of sales includes the purchase cost of products sold and all costs associated with getting the products to the customers including buying and transportation costs. Cost of sales all related to discontinued operations.

Shipping Costs

Shipping and handling costs billed to customers are recorded in sales. Shipping costs incurred by the company are recorded in general and administrative expenses. Shipping costs all related to discontinued operations.

Fair Value Measurements

The Company applies the guidance that is codified under ASC 820-10 related to assets and liabilities recognized or disclosed in the financial statements at fair value on a recurring basis. ASC 820-10 defines fair value, establishes a framework for measuring fair value and expands disclosures about fair value measurements.

The Company’s financial instruments are cash and cash equivalents, accounts receivable, accounts payable, notes payable, and long-term debt. The recorded values of cash and cash equivalents and accounts payable approximate their fair values based on their short-term nature. The recorded values of notes payable and long-term debt approximate their fair values, as interest approximates market rates.

Fair Value Measurements (continued)

ASC 820-10 clarifies that fair value is an exit price, representing the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants based on the highest and best use of the asset or liability. As such, fair value is a market-based measurement that is determined based on assumptions that market participants would use in pricing an asset or liability. ASC 820-10 requires valuation techniques to measure fair value that maximize the use of observable inputs and minimize the use of unobservable inputs. These inputs are prioritized as follows:

Fair Value Hierarchy		Inputs to Fair Value Methodology
Fair ValueHierarchy		Inputs to Fair Value Methodology
Level 1		Quoted prices in active markets for identical assets or liabilities
Level 2		Quoted prices for similar assets or liabilities; quoted markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the financial instrument; inputs other than quoted prices that are observable for the asset or liability; or inputs that are derived principally from, or corroborated by, observable market information
Level 3		Pricing models, discounted cash flow methodologies or similar techniques and at least one significant model assumption is unobservable or when the estimation of fair value requires significant management judgment

All items required to be recorded or measured on a recurring basis are based upon Level 3 inputs.

F-14

Table of Contents

To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, for disclosure purposes, the level in the fair value hierarchy within which the fair value measurement is disclosed and is determined based on the lowest level input that is significant to the fair value measurement.

The Company recognizes its derivative liabilities as Level 3 and values its derivatives using the methods discussed below. While the Company believes that its valuation methods are appropriate and consistent with other market participants, it recognizes that the use of different methodologies or assumptions to determine the fair value of certain financial instruments could result in a different estimate of fair value at the reporting date. The primary assumptions that would significantly affect the fair values using the methods discussed are that of volatility and market price of the underlying common stock of the Company.

F-16 Table of Contents

NOTE 5: SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

that would significantly affect the fair values using the methods discussed are that of volatility and market price of the underlying common stock of the Company.

The Company’s acquired goodwill with a carrying amount of $2,458,233 were written down to zero, resulting in an impairment charge of $2,458,233, which was included in earnings for the period ending September 30, 2020.

In-process Research and Development with a carrying amount of $5,848,219 was written down to its implied fair value of zero, resulting in an impairment charge of $5,848,219, which was included in earnings for the period ending December 31, 2021.

Items recorded or measured at fair value on a recurring basis in the accompanying consolidated financial statements consisted of the following items as of December 31, ~~2022~~ 2023.

		Total				Level 1				Level 2				Level 3
Derivative liabilities		$	2,482,723			$	-			$	-			$	2,482,723

December 31, 2022:

		Total				Level 1				Level 2				Level 3
Derivative liabilities		$	1,648,831			$	-			$	-			$	1,648,831

Convertible Instruments

The Company evaluates and accounts for conversion options embedded in its convertible instruments in accordance with professional standards for “Accounting for Derivative Instruments and Hedging Activities.”

Professional standards generally provide three criteria that, if met, require companies to bifurcate conversion options from their host instruments and account for them as free standing derivative financial instruments. These three criteria include circumstances in which (a) the economic characteristics and risks of the embedded derivative instruments are not clearly and closely related to the economic characteristics and risks of the host contract, (b) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable generally accepted accounting principles with changes in fair value reported in earnings as they occur and (c) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. Professional standards also provide an exception to this rule when the host instrument is deemed to be conventional as defined under professional standards as “The Meaning of “Conventional Convertible Debt Instrument.”

The Company accounts for convertible instruments (when it has determined that the embedded conversion options should not be bifurcated from their host instruments) in accordance with professional standards when “Accounting for Convertible Securities with Beneficial Conversion Features,” as those professional standards pertain to “Certain Convertible Instruments.” Accordingly, the Company records, when necessary, discounts to convertible notes for the intrinsic value of conversion options embedded in debt instruments based upon the differences between the fair value of the underlying common stock at the commitment date of the note transaction and the effective conversion price embedded in the note. Debt discounts under these arrangements are amortized over the term of the related debt to their earliest date of redemption. The Company also records when necessary deemed dividends for the intrinsic value of conversion options embedded in preferred shares based upon the differences between the fair value of the underlying common stock at the commitment date of the note transaction and the effective conversion price embedded in the note.

F-15

Table of Contents

ASC 815-40 provides that, among other things, generally, if an event is not within the entity’s control could or require net cash settlement, then the contract shall be classified as an asset or a liability.

Income Taxes

The Company follows Section 740-10, Income tax (“ASC 740-10”) Fair Value Measurements and Disclosures of the FASB Accounting Standards Codification, which requires recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred tax assets and liabilities are based on the differences between the financial statement and tax Bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance to the extent management concludes it is more likely than not that the assets will not be realized. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the Statements of Operations in the period that includes the enactment date.

F-17 Table of Contents

NOTE 5: SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance to the extent management concludes it is more likely than not that the assets will not be realized. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the Statements of Operations in the period that includes the enactment date.

The Company recognizes deferred tax assets to the extent that the Company believes that these assets are more likely than not to be realized. In making such a determination, the Company considers all available positive and negative evidence, including reversals of any existing taxable temporary differences, projected future taxable income, tax planning strategies, and the results of recent operations. If the Company determines that it would be able to realize a deferred tax asset in the future in excess of any recorded amount, the Company would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes.

The Company adopted section 740-10-25 of the FASB Accounting Standards Codification (“Section 740-10-25”). Section 740-10-25 addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the financial statements. Under Section 740-10-25, the Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such a position should be measured based on the largest benefit that has a greater than fifty percent (50%) likelihood of being realized upon ultimate settlement. Section 740-10-25 also provides guidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures. The Company had no liabilities for unrecognized income tax benefits according to the provisions of Section 740-10-25.

No amounts were accrued for the payment of interest and penalties as of December 31, ~~2022~~2023 and ~~2021~~2022. The Company is not aware of any uncertain tax positions that could result in significant additional payments, accruals, or other material deviation for the years ended December 31, ~~2022~~2023 and ~~2021~~2022.

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (the “Cares Act”) was enacted. The CARES Act included loans and grants to certain businesses, and temporary amendments to the Internal Revenue Code which changed net loss carryforward and back provisions and the business interest expenses limitation. Under the CARES Act provisions, the most relevant income tax considerations to the Company relate to the amounts received under the Paycheck Protection Program loan program and the possible forgiveness of those loans by the SBA.

On December 21, 2020, the U.S. president has signed into law the “Consolidated Appropriations Act, 2021” which includes further COVID-19 economic relief and extension of certain expiring tax provisions. The relief package includes a tax provision clarifying that businesses with forgiven PPP loans can deduct regular business expenses that are paid for with the loan proceeds for federal tax purposes. Additional pandemic relief tax measures include an expansion of the employee retention credit, enhanced charitable contribution deductions, and a temporary full deduction for business expenses for food and beverages provided by a restaurant.

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Table of Contents

Concentrations of Credit Risk

Financial instruments and related items, which potentially subject the Company to concentrations of credit risk, consist primarily of cash and cash equivalents. The Company had $-0- and $-0- allowance for doubtful accounts at December 31, ~~2022~~2023 and ~~2021~~2022, respectively and had $-0- accounts receivable at December 31, ~~2022~~2023 and ~~$- at~~ December 31, ~~2021~~2022.

F-18 Table of Contents

NOTE 5: SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

Net Loss per Common Share

Net loss per common share is computed pursuant to section 260-10-45 Earnings Per Share (“ASC 260-10”) of the FASB Accounting Standards Codification. Basic net loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding and the member potentially outstanding during each period. In periods when a net loss is experienced, only basic net loss per share is calculated because to do otherwise would be anti-dilutive. Basic and diluted net loss per share of common stock, par value $0.0001 per share (“Common Stock”) is presented in conformity with ASC 260-10 “Earnings Per Share.”

~~There~~Diluted ~~were~~net ~~common~~loss per share ~~equivalents~~is ~~47,298,693~~the atsame ~~December~~as ~~31,~~basic ~~2022~~net ~~and~~loss ~~30,530,216~~per atshare ~~December~~for ~~31,~~2023 ~~2021.~~as ~~For~~ the ~~year~~inclusion ~~ended~~of ~~December 31~~24,118,329 ~~2022~~in ~~and~~stock ~~2021~~options, ~~these~~3,544,247 ~~potential~~in ~~shares~~warrants ~~were~~, ~~excluded~~and ~~from~~222,364,674 ~~the~~in ~~shares~~convertible ~~used~~notes ~~to calculate diluted earnings per share as their inclusion~~ would ~~reduce~~be ~~net loss per share~~anti-dilutive.

There were common share equivalents 250,027,250 at December 31, 2023 and 47,298,693 at December 31, 2022. For the year ended December 31, 2023 and 2022 these potential shares were excluded from the shares used to calculate diluted earnings per share as their inclusion would reduce net loss per share.

Stock Based Compensation

All stock-based payments to employees and to nonemployee directors for their services as directors, including any grants of restricted stock and stock options, are measured at fair value on the grant date and recognized in the statements of operations as compensation or other expense over the relevant service period. Stock-based payments to nonemployees are recognized as an expense over the period of performance. Such payments are measured at fair value at the earlier of the date a performance commitment is reached, or the date performance is completed. In addition, for awards that vest immediately and are non-forfeitable the measurement date is the date the award is issued. The Company accounts for stock options issued to non-employees based on the estimated fair value of the awards using the Black-Scholes option pricing model in accordance with ASC 505-50, Equity-Based Payment to Non-employees. Stock-based compensation expense related to stock options granted to non-employees is recognized as the stock options vest. The Company believes that the fair value of the stock options is more reliably measurable than the fair value of the services received. Stock options granted to non-employees are recorded at their fair value on the measurement date and are subject to periodic adjustments as such options vest and at the end of each reporting period, and the resulting change in value, if any, is recognized in the Company’s statements of operations and comprehensive loss during the period the related services are rendered.

Research and Development

The Company accounts for research and development costs in accordance with the Accounting Standards Codification subtopic 730-10, Research and Development (“ASC 730-10”). Under ASC 730-10, all research and development costs must be charged to expense as incurred. Accordingly, internal research and development costs are expensed as incurred. Third-party research and development costs are expensed when the contracted work has been performed or as milestone results have been achieved. Company-sponsored research and development costs related to both present and future products are expensed in the period incurred. For the twelve months ended December 31, ~~2022~~2023 and ~~2021~~2022 The Company incurred research and development expenses of $~~153~~125,~~697~~496 and $~~284~~153,~~869~~697 from ~~continuing~~ operations, respectively. ~~For the twelve months ended December 31, 2022 and 2021 the Company incurred research and development expenses of $0 and $0 from discontinued operations, respectively.~~ The Company has entered into various agreements with CROs. The Company’s research and development accruals are estimated based on the level of services performed, progress of the studies, including the phase or completion of events, and contracted costs. The estimated costs of research and development provided, but not yet invoiced, are included in accrued liabilities on the balance sheet. If the actual timing of the performance of services or the level of effort varies from the original estimates, the Company will adjust the accrual accordingly. Payments made to CROs under these arrangements in advance of the performance of the related services are recorded as prepaid expenses and other current assets until the services are rendered.

F-19 Table of Contents

NOTE 5: SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

Recently Accounting Pronouncements

In March 2020, the FASB issued a new accounting standard to ease the financial reporting burdens caused by the expected market transition from the LIBOR and other interbank offered rates to alternative reference rates, commonly referred to as reference rate reform. The new standard provides temporary optional expedients and exceptions to current GAAP guidance on contract modifications and hedge accounting. Specifically, a modification to transition to an alternative reference rate is treated as an event that does not require contract re-measurement or reassessment of a previous accounting treatment. Moreover, for all types of hedging relationships, an entity is permitted to change the reference rate without having to de-designate the hedging relationship. In January 2021, the FASB issued a new accounting standard to expand the scope of the original March 2020 standard to include derivative instruments on discounting transactions. The provisions of these standards have not had and are not expected to have a material impact on our consolidated financial statements.

In November 2021, the FASB issued a new accounting standard around the recognition and measurement of contract assets and contract liabilities from revenue contracts with customers acquired in a business combination. The new standard clarifies that contract assets and contract liabilities acquired in a business combination from an acquiree should initially be recognized by applying revenue recognition principles and not at fair value. The standard is effective for interim and annual periods beginning on January 1, 2023, and early adoption is permitted. The impact of this standard will depend on the facts and circumstances of future transactions.

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Table of Contents

In August 2020, the FASB issued ASC Update No. 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. The amendments in Update No. 2020-06 simplify the complexity associated with applying U.S. GAAP for certain financial instruments with characteristics of liabilities and equity. More specifically, the amendments focus on the guidance for convertible instruments and derivative scope exception for contracts in an entity’s own equity. The provisions of these standards have not had and are not expected to have a material impact on our consolidated financial statements.

Recently Adopted Accounting Pronouncements

In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The main objective of the standard is to provide financial statement users with more decision-useful information about the expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date. To achieve this objective, the amendments in this standard replace the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The update is effective for the Company beginning January 1, 2023 with early adoption permitted. The Company adopted the standard on January 1, 2023. The adoption of this standard did not have a material effect on the Company’s audited consolidated financial statements and related disclosures.

Recently Issued Accounting Pronouncements Not Yet Adopted

In October 2023, the FASB issued ASU 2023-06—Codification Amendments in Response to the SEC's Disclosure Update and Simplification Initiative. The main objective of the amendment is to modify the disclosure or presentation requirements of various Topics in the Codification. Certain amendments represent clarifications to or technical corrections of the current requirements. to eliminate disclosure requirements that were redundant, duplicative, overlapping, outdated, or superseded. The effective date for each amendment will be when the SEC's removal of that related disclosure from Regulation S-X or Regulation S-K becomes effective, with early adoption prohibited. The Company is still evaluating the impact of the adoption of this standard.

Other recent accounting pronouncements issued by the FASB and the SEC did not or are not believed by management to have a material impact on the Company’s present or future consolidated financial statements.

NOTE 6: PREPAID EXPENSES

Prepaid expenses consist of the following as of December 31, ~~2022~~2023 and ~~2021~~2022:

	December 31,		December 31,
	2022		2021
	2023		2022
Prepaid insurance	$	~~42,078~~0	$	5842,~~853~~078
Prepaid services/other		~~780~~0		~~104,708~~780
	$	~~42,858~~0	$	~~163~~42,~~561~~858

For the year ended December 31, ~~2022~~2023 and ~~2021~~2022 the Company recognized amortization of prepaid expense and insurance of $~~210~~42,~~094~~858- and $~~376~~210,~~936~~094 respectively.

NOTE 7: PROMISSORY NOTE

On December 31, 2019, Sapphire Biotech, Inc. had entered into a Debt Exchange Agreement whereas the Company assumed three (3) loans totaling $128,375 of Debt owned by Sapphire Diagnostics, LLC which had an interest rate of 6% per annum. In the same Debt Exchange Agreement, the Company assumed four (4) additional loans made to Sapphire in 2019, which had an interest rate of 6% per annum. All seven (7) loans totaling $310,000, plus the aggregate interest accrued thereon of $14,218 making the face value of the new note $324,218. As of December 31, ~~2022~~2023 and ~~2021~~2022 respectively, the principal and accrued interest balances were $-0- and $363,178 respectively. The note was refinanced January 27, 2022. With an effective date of April 01, 2022 the Note is convertible into Axim common shares at a strike price of $0.1075 per share. The interest rate is 3% compounded monthly. The note is due January 27, 2032. This note now shows as a long term convertible note payable (see Note 11).

OnF-18 ~~July~~Table ~~29, 2021, the Company recorded a $210,000 note payable in conjunction with the acquisition~~ of patents from Advanced Tear Diagnostics LLC. The note balance as of December 31, 2021 is $90,000 with accrued interest of $1,515. The note was paid off February 2022 and has a zero balance as of December 31, 2022Contents

~~F-20~~On ~~Table~~July 29, 2021, the Company recorded a $210,000 note payable in conjunction with the acquisition of ~~Contents~~patents from Advanced Tear Diagnostics LLC. The note balance as of December 31, 2021 is $90,000 with accrued interest of $1,515. The note was paid off February 2022 and has a zero balance as of December 31, 2023.

NOTE 8: OTHER COMMITMENTS

On July 29, 2021, the Company recorded a $210,000 note payable in conjunction with the acquisition of patents from Advanced Tear Diagnostics LLC. The note balance as of December 31, ~~2022~~2023 and ~~2021~~2022 is $-0- and $~~90,000~~-0- with accrued interest of $-0- and $1-0-,~~515,~~ respectively.

NOTE 9: RELATED PARTY TRANSACTIONS

Related Party

The company has an employment agreement with Catalina Valencia at a rate of $15,000 per month commencing March 17, 2020. The agreement can be terminated with 30 days’ notice by either party.

The company has a consulting agreement with Glycodots LLC whereby it will provide the services of Dr. Sergei A. Svarovsky at a rate of $15,000 per month commencing March 17, 2020. The agreement can be terminated with 30 days’ notice by either party.

Purchase of Promissory Note and Forbearance Agreement

Effective May 4, 2020, the Company acquired from TL-66, a California limited liability company (“Seller”), a promissory note issued to Seller by Dr. Anastassov (“Maker”) dated December 1, 2017, with a face value of $350,000 and a remaining balance due of approximately $100,000 (the “Note”). The purchase price for the Note was $100,000 payable by the Company issuing Seller One Million (1,000,000) restricted shares of the Company’s Common Stock. Effective May 6, 2020, the Company and Maker entered into a Forbearance Agreement whereby the Company agreed to forbear from making any collection efforts on the Note for a period of 24 months so long as Maker has not breached the Separation Agreement. Following 24 months, if there has been no breach of the Separation Agreement by Maker, repayment of the Note, including all principal and unpaid interest, will be waived in full. As of May, 4, 2020 the carrying value of the note receivable was $102,567, the value of the common stock to be issued was $135,000, resulting in a loss of $32,433 accounted as loss on debt extinguishment related to discontinued operations. The balance of the Note Receivable as of December 31, ~~2022~~2023 and ~~2021~~2022 is $-0- and $102,567 excluding interest accrued thereon of $-0- and $1,701, respectively. The note was forgiven in May, 2022.

NOTE 10: DUE TO FIRST INSURANCE FUNDING

On June 25, 2022, the Company renewed its D&O insurance policy with total premiums, taxes and fees for $87,762. A cash down payment of $8,776 was paid on July 6, 2022. Under the terms of the insurance financing, payments of $8,957, which include interest at the rate of 4.92% per annum, are due each month for nine months commencing on July 25, 2022. The policy was cancelled in early 2023 for non payment of premium.

On June 25, 2021, the Company renewed its D&O insurance policy with total premiums, taxes and fees for $98,888. A cash down payment of $24,273 was paid on July 7, 2021. Under the terms of the insurance financing, payments of $1,797, which include interest at the rate of 4.420% per annum, are due each month for nine months commencing on July 25, 2021.

The total outstanding due to First Insurance Funding as of December 31, ~~2022~~2023 and ~~2021~~2022 is $~~26,781~~-0- and $3226,~~873~~781, respectively.

F-2119 Table of Contents

NOTE 11: CONVERTIBLE NOTES PAYABLE

The following table summarizes convertible note payable of related ~~party~~parties as of December 31, ~~2022~~2023 and ~~2021~~2022:

	December 31,		December 31,
	2022		2021
	2023		2022
Convertible note payable, due on November 1, 2026, interest at 3.5% p.a.	$	4,000,000	$	4,000,000
Accrued interest		261,537		299,037
Convertible note Payable MMI due on December 26, 2033 interest at 5.25% p.a. (7)		100,000
Convertible note payable, net	$	4,261,537	$	4,299,037
Convertible Note Payable John Huemoeller due on January 23, 2033 interest at 4.0% p.a. (6)		250,000
Convertible note payable, due on February 10, 2032, interest at 3.0% p. a. (5)		375,000
Accrued Interest		160,091		261,537
Total	$	4,885,091	$	4,261,537
Less: unamortized debt discount/finance premium costs		631,123
Convertible notes payable related parties, net		4,253,968		4,261,537

The interest on this note is payable bi-annually every May 1 and November 1.

In 2020 the Company was authorized to apply the accounts receivable of $75,074 due from Kannaway towards its accrued interest.

On May 1, 2020, the Company agreed to modify its existing convertible note with a principal balance of $4 million, 3.5% interest rate convertible note with the current holder of that note. There were two changes to the existing agreement – (a) the conversion price was reduced from the $1.50 conversion price in the original Note to $0.25 cents in the modified Note and (b) the term of the note was extended from the original maturity date of November 1, 2021, to November 1, 2026. The Company’s stock closed trading on the day of the modification at $0.13 per share. The amendment of this convertible Note was also evaluated under ASC Topic 470-50-40, ”Debt Modifications and Extinguishments.” Based on the guidance, the instruments were determined to be substantially different due to the change in the conversion price being substantial, and debt extinguishment accounting was applied. The fair value of the modified convertible note was not different than the carrying value of the original note as such no extinguishment loss was recorded, The Note prior to the amendment of approximately $4 million, and the fair value of the Note and embedded derivatives after the amendment of approximately $4 million. There were no unamortized debt issuance costs and the debt discount associated with the original 2018 Note.

~~For~~On January 23, 2023, Creditor agreed to waive and forfeit all interest accrued on the ~~years~~MMI ~~ended~~Note through December 31, 2022, in the aggregate amount of $261,537, and ~~2021~~to waive all prior defaults on the MMI Note through the Effective Date. Interest shall accrue on the MMI Note at the original rate of 3.5% per annum through September 30, 2023, and be payable on that date. Thereafter interest ~~expense~~will ~~was~~be payable on a monthly basis beginning on August 1, 2023. In addition, the Conversion Price for the MMI Note is hereby reduced from $~~140~~0.25 to $0.075 the reduction in conversion price was also effective January 23,~~000~~ 2023. This Agreement serves to modify and ~~$140~~amend the MMI Note as set forth herein,~~389,~~ ~~respectively~~in all other respects the terms of the MMI Note remain in full force and effect. The Company determined that the debt modification including conversion feature added resulted in a debt extinguishment due to the change in the fair values exceeding 10% of the debt carrying value. As a result of the debt modification the company recorded a gain on Extinguishment of debt in the amount of $261,537.

AsF-20 ofTable ~~December 31, 2022 and 2021, the balance~~ of ~~secured convertible note was $4,261,537 and $4,299,037 which included $261,537 and $299,037 accrued interest, respectively.~~Contents

~~The~~For ~~following~~the ~~table~~years ~~summarizes~~ended ~~convertible~~December ~~note~~31, ~~payable~~2023 asand of2022, ~~December~~interest ~~31,~~expense ~~2022~~was $140,000 and ~~2021:~~$261,537, respectively.

	December 31,			December 31,
	2022			2021
Convertible note payable, due on October 1, 2029, interest at 3.5% p.a.	$	484,478		$	484,478
Convertible Note Payable, due on October 1, 2022, interest at 6% p.a.		-			1,110,000
Convertible note payable, due on October 1, 2029, interest at 3.5% p.a.		500,000			500,000
Convertible note payable, due on December 31, 2034, interest at 3% p.a.		190,000			190,000
Convertible Note payable due January 27, 2032 interest at 3% p.a.		367,931			-
Convertible note payable, due on February 10, 2032, interest at 3.0% p.a.		1,150,000			-
Accrued interest (The accrued interest and principal are both included in the captions titled “convertible note payable” in the balance sheet)		274,442			209,685
Total		2,966,851			2,494,163
Less: unamortized debt discount/finance premium costs		(1,583,435	)		(605,640	)
Convertible note payable, net	$	1,383,416		$	1,888,523

As of December 31, 2023 and 2022, the balance of secured convertible note was $4,140,000 and $4,261,537 which included $140,000 and $261537 accrued interest, respectively.

The following table summarizes convertible note payable as of December 31, 2023 and 2022:

	December 31,			December 31,
	2023			2022
Convertible note payable, due on October 1, 2029, interest at 3.5% p.a. (1)	$	484,478		$	484,478
Convertible Note Payable, due on January 27,2032 interest at 3% p.a. (4)		367,931			367,931
Convertible note payable, due on October 1, 2029, interest at 3.5% p.a. (2)		500,000			500,000
Convertible note payable, due on February 10, 2032, interest at 3.0% p. a. (5)		425,000			1,150,000
Convertible note payable, due on December 31, 2034, interest at 3% p.a. (3)		190,000			190,000
Convertible note payable, due on May 23, 2033, interest at 3.75% p.a. see 8 below		250,000			-
Convertible note payable, due on May 23, 2033, interest at 3.75% p.a. see 8 below		325,000			-

Accrued interest (The accrued interest and principal are both included in the captions titled “convertible note payable” in the balance sheet)		76,163			274,442
Total		2,618,572			2,966,851
Less: unamortized debt discount/finance premium costs		(1,209,806	)		(1,583,435	)
Convertible note payable, net	$	1,408,766		$	1,383,416

(1) On September 16, 2016, we entered into a convertible note purchase agreement (the “Convertible Note Purchase Agreement” or “Agreement”) with a third-party investor. Under the terms of the Convertible Note Purchase Agreement the investor may acquire up to $5,000,000 of convertible notes from the Company. With various closings, under terms acceptable to the Company and the investor as of the time of each closing. Pursuant to the Agreement, on September 16, 2016 the investor provided the Company with $850,000 secured convertible note financing pursuant to four (4) Secured Convertible Promissory Notes (the “Notes”). Each of the Notes matures on October 1, 2029, and pay 3.5% compounded interest paid bi-annually. The Note are secured by the assets of the Company, may not be pre-paid without the consent of the holder, and are convertible at the option of the holder into shares of the Company common stock at a conversion price equal to $0.2201 per share.

As of December 31, 2023 and December 31, 2022 respectively, the balance of secured convertible notes was $501,811 and $590,945, which included $17,333 and $106,467 accrued interest, respectively. See below for debt modification treatment.

(2) On October 20, 2016, a third-party investor provided the Company with $1,000,000 secured convertible note financing pursuant to three (3) Secured Convertible Promissory Notes (the “Notes”). Each of the Notes mature on October 1, 2029 and pay 3.5% compounded interest paid bi-annually. The Notes are secured by the assets of the Company, may not be pre-paid without the consent of the holder, and are convertible at the option of the holder into shares of the Company’s common stock at a fixed conversion price equal of $0.2201 per share. The investor paid cash of $500,000 for one of the Notes and issued to the Company two (2) secured promissory notes of $250,000 each for two (2) Convertible Notes of $250,000 each. The two secured promissory notes issued by the investor (totaling $500,000) as payment for two (2) secured Notes totaling $500,000 mature on February 1, 2017 ($250,000) and March 1, 2017 ($250,000), bear interest at the rate of 1% per annum, are full recourse and additionally secured by 10,486,303 shares of Medical Marijuana, Inc. (Pink Sheets symbol: MJNA) and were valued at $858,828 based upon the closing price of MJNA on October 20, 2016. A debt discount was recorded related to beneficial conversion feature inn connection with this convertible note of $499,318, related to the beneficial conversion feature of the note to be amortized over the life of the note or until the note is converted or repaid. As of December 31, 2023 and December 31, 2022 respectively, this note has not been converted and the balance of secured convertible notes was $517,888 and $610,104, which included $17,888 and $110,104 accrued interest, respectively. See below for debt extinguishment treatment.

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Table of Contents

(1) & (2) On January 23, 2023, Creditor agreed to waive and forfeit all interest accrued on the Secured Notes through December 31, 2022, in the aggregate amount of $216,572. All prior defaults on the Secured Notes are hereby waived through the Effective Date, and the next interest payments due on each of the Secured Notes is extended from April 1, 2023, to July 1, 2023. In addition, the Conversion Price for each of the Secured Notes is hereby reduced from $0.2201 to $0.04. The Agreement served to modify and amend each of the Secured Notes as set forth above, in all other respects the terms of the Secured Notes remained in full force and effect. The Company determined that the debt modification including conversion feature added resulted in a debt extinguishment due to the change in the fair values exceeding 10% of the debt carrying value.

The Renegotiation of the above TL-66 notes was deemed to be a debt extinguishment resulting in Amortization of the remaining debt discount of $381,760 and recognition of the Beneficial conversion feature upon modification of $209,522. And a gain on conversion of $35,537 calculated by comparing fair value of new note to old note including accrued interest.

(3) On December 31, 2019, Sapphire Biotech, Inc. entered into a Convertible Note Purchase Agreement whereas the Company issued a convertible note with a face value of $190,000 with a compounding interest rate of 3% per annum, the interest shall be payable annually beginning on December 31, 2020 until the maturity date of December 31, 2034, at which time all principal and interest accrued thereon shall be due and payable. The Convertible Note is secured by substantially all the Company’s tangible and intangible assets. In addition, the Convertible Note includes various non-financial covenants including the Company may not enter into any agreement, arrangement or understanding of any kind that would result in a transaction, or series of transactions, that would result in the sale of 50% or more of the Company’s capital stock without the prior approval of the holder.

Upon issuance, the Convertible Note was convertible into shares of the Company’s common stock at $1.90 per share. At December 31, 2019, the Company determined that the Convertible Note contained a beneficial conversion feature for which a full discount was recorded on the Convertible Note. The fair market value of the Company’s common stock was based upon the estimated per share acquisition price per the pending acquisition of the Company. The discount of $190,000 will be amortized using the effective interest method and will be fully amortized by December 31, 2034.

On March 17, 2020, the Company entered into a Share Exchange Agreement (“Agreement”) with Sapphire Biotech, Inc., a Delaware corporation (“Sapphire”) and all of the Sapphire stockholders (collectively, the “Sapphire Stockholders”). Following the closing of the transaction, Sapphire will become a wholly owned subsidiary of AXIM. Under the terms of the Agreement, the Company intends to assume the convertible notes in the principal amounts of $190,000. After the acquisition, the Convertible Note was able to convert 6,000,000 shares of Axim’s common stock. Upon assumption of the note, the Company recorded a beneficial conversion feature of $190,000. As of December 31, 2023 and December 31, 2022, the balance of secured convertible note was $195,701 and $207,116, which included $5,701 and $17,116 accrued interest, respectively.

On January 27, 2023, Creditor agreed to waive and forfeit all interest accrued on the Sapphire Note through December 31, 2022, in the aggregate amount of $17,115 and to waive all prior defaults on the Sapphire Note through the Effective Date. This was not deemed to be a debt extinguishment since the waiver of accrued interest was not deemed to produce a change in cash flow greater than 10%. The company recorded a gain on modification of $17,117 resulting from forgiveness of accrued interest.

(4) On January 27, 2022, Sapphire Bitotech entered into a debt exchange agreement (effective April 1 2022) whereas the company exchanged a convertible note with a balance of 367,931 including accrued interest for a new note charging interest at a rate of 3% per annum first interest payment due January 27, 2023 compounded monthly. The maturity date is January 27, 2032. Upon issuance was convertible into shares of the Company’s common stock at a conversion price of $0.10 per share. As of December 31, 2023 and December 31, 2022, the balance of secured convertible note was $378,066 and $378,193, which included $10,135 and $10,262 accrued interest, respectively. This was not deemed to be a debt extinguishment.

F-22

Table of Contents

~~NOTE~~On January 23, 2023, Creditor agreed to waive and forfeit all interest accrued on the TL-66 Note through January 27, 2023, in the aggregate amount of $11:,190, ~~CONVERTIBLE~~and ~~NOTES~~to ~~PAYABLE~~waive ~~(CONTINUED)~~all prior defaults on the TL-66 Note through the Effective Date. This was not deemed to be a debt extinguishment since the waiver of accrued interest was not deemed to produce a change in cash flow greater than 10%. The company recorded a gain on modification of $11,190 resulting from forgiveness of accrued interest.

~~On September 16, 2016, we entered into a convertible note purchase agreement (the “~~Convertible Note ~~Purchase~~payable ~~Agreement”~~– orrelated ~~“Agreement”) with a third-~~party investor. Under the terms of the Convertible Note Purchase Agreement the investor may acquire up to $5,000,000 of convertible notes from the Company. With various closings, under terms acceptable to the Company and the investor as of the time of each closing. Pursuant to the Agreement, on September 16, 2016 the investor provided the Company with $850,000 secured convertible note financing pursuant to four (4officer) Secured Convertible Promissory Notes (the “Notes”). Each of the Notes matures on October 1, 2029, and pay 3.5% compounded interest paid bi-annually. The Note are secured by the assets of the Company, may not be pre-paid without the consent of the holder, and are convertible at the option of the holder into shares of the Company common stock at a conversion price equal to $0.2201 per share.

As(5) ofConvertible ~~December 31, 2022 and 2021, the balance of secured convertible notes was $590,945 and $573,612, which included $106,467 and $89,134 accrued interest, respectively.~~Notes

OnEffective ~~September~~February 2710, ~~2021~~2022, the Company ~~entered~~issued ~~into~~seven convertible ~~note~~notes purchase agreement with GS Capital LLC in the amount of $1,110,000. The note had an original issue discount of $100,000. It bears interest at a rate of 6% and matures October 1. The note is convertible to ~~free trading shares six months after issuance at~~ a ~~conversion~~series ~~price~~ of ~~$0.25~~investors ~~per~~having ~~share~~an ~~subject~~aggregate toface avalue ~~10-day look back period at time~~ of ~~conversion if the stock is trading at less than~~ $~~0.25 for more than 5 days then the conversion price will be a 30 percent discount to the average of the two lowest closing prices within the 10 day look back period. On February 10~~1, ~~2022~~325,000 ~~the Company paid~~ in ~~full~~exchange ~~the~~for ~~remaining balance due on that certain convertible note issued to GS Capital Partners, LLC, face value~~ $1,~~110~~325,000 ~~(as~~in ~~amended,~~cash (the “GSConvertible ~~Note~~Notes”). InOne ~~connection with the repayment, the Company was required to pay accrued interest in the amount~~ of ~~$21,863, by issuing 173,390 restricted shares of~~ the ~~Company’s~~Convertible ~~common stock pursuant to the formula set forth in the GS Note. The shares were issued February 22~~Notes, ~~2022~~face ~~and~~value ~~valued at the closing price on that date at~~ $~~0.19 per shares which was valued at $32~~25,~~944 for the accrued interest of $21~~000,~~863~~ ~~and the balance $11,081~~ was ~~recorded~~purchased asby ~~loss~~Blake onN. ~~conversion~~Schroeder ~~under~~who ~~loss~~is ona ~~extinguishment~~director of ~~debt in statement of operation. Also~~ the Company ~~paid $133,200 as penalty for early repayment recorded under interest expenses in statement of operation~~. ~~As of December 31, 2022 and 2021, the balance of this convertible note was $0 and $1,126,919, which included $0 and $16,919 accrued interest; respectively.~~

OnEach ~~October~~of ~~20,~~the ~~2016~~Convertible aNotes ~~third-party~~is ~~investor~~(i) ~~provided~~unsecured; ~~the~~(ii) ~~Company~~bears ~~with~~interest ~~$1,000,000~~at ~~secured~~a ~~convertible~~rate ~~note~~of ~~financing~~3% ~~pursuant~~per toannum; ~~three~~ (3iii) ~~Secured~~matures ~~Convertible~~on ~~Promissory~~February ~~Notes~~10, 2032; and (iv) is convertible, in whole or in part, at any time by the ~~“Notes”).~~holder, ~~Each~~into restricted shares of the ~~Notes~~Company’s ~~mature~~common onstock ~~October~~at 1,a ~~2029~~conversion ~~and~~price ~~pay~~equal ~~3.5%~~to ~~compounded~~the ~~interest~~lesser ~~paid~~of ~~bi-annually~~$0.08125 ~~The~~or ~~Notes~~70% ~~are~~of ~~secured~~the byaverage of the ~~assets~~two lowest closing prices of the Company,’s ~~may~~common ~~not~~stock bein ~~pre-paid~~the ~~without~~ten ~~the~~trading ~~consent~~days ofpreceding any particular conversion, provided, the holder, ~~and~~is ~~are~~prohibited ~~convertible~~from atconverting the ~~option~~convertible ofnote, or portion thereof, if such conversion would result in beneficial ownership by the holder ~~into~~and ~~shares~~its affiliates of ~~the~~more than 4.999% of Company’s issued and outstanding common stock atas aof ~~fixed~~the date of the conversion. ~~price~~A ~~equal~~debt ofdiscount ~~$0.2201~~was ~~per~~recorded ~~share.~~related ~~The~~to ~~investor~~beneficial ~~paid~~conversion ~~cash~~feature in connection with this convertible note of $~~500~~1,325,000, ~~for~~which ~~one~~to ofbe amortized over the ~~Notes~~life ~~and~~of ~~issued~~the tonote or until the ~~Company~~note ~~two~~is ~~(2)~~converted ~~secured~~or ~~promissory~~repaid. ~~notes~~During ofthe year ended December 31, 2022, $~~250~~175,000 ~~each~~of ~~for~~the ~~two~~note ~~(2)~~and ~~Convertible~~accrued ~~Notes~~interest of $~~250~~2,~~000~~840 ~~each.~~was ~~The~~retired ~~two~~and ~~secured~~converted ~~promissory~~to ~~notes~~5,665,636 ~~issued~~common byshares ~~the~~valued ~~investor~~at ~~(totaling~~ $~~500~~349,~~000)~~535 and as ~~payment~~a ~~for~~result ~~two~~recognized ~~(2)~~a ~~secured~~loss ~~Notes~~on ~~totaling~~extinguishment of $~~500~~111,~~000~~807, ~~mature~~including oncancellation ~~February~~of 1,balance ~~2017~~debt (discount of $~~250~~167,~~000)~~571 and ~~March~~a 1,gain ~~2017~~due ~~($250,000),~~to ~~bear~~cancellation ~~interest~~of atderivative ~~the~~liabilities ~~rate~~as of 1%date ~~per~~of ~~annum,~~settlement ~~are~~of ~~full~~$227,459 ~~recourse~~During ~~and~~the ~~additionally~~year ~~secured~~ended byDecember 1031,~~486~~ 2023,~~303~~ ~~shares~~$350,000 of ~~Medical~~the ~~Marijuana,~~note ~~Inc.~~and ~~(Pink~~accrued ~~Sheets~~interest ~~symbol:~~of ~~MJNA)~~$30,858 was retired and ~~were~~converted to 22,207,486 common shares valued at $~~858~~688,~~828~~432 ~~based~~and ~~upon~~as ~~the~~a ~~closing~~result ~~price~~ of ~~MJNA~~the ondebt ~~October~~modification ~~20,~~the ~~2016.~~company Arecognized ~~debt~~a ~~discount~~loss ~~was~~on ~~recorded~~extinguishment ~~related~~of to$626,414, ~~beneficial~~including ~~conversion~~cancellation ~~feature~~of inbalance ~~connection~~debt ~~with~~discount ~~this convertible note~~ of $~~499,~~318,840 ~~related~~and toa ~~the~~loss ~~beneficial~~on ~~conversion~~issuance ~~feature~~ of the ~~note~~shares toof be$307,574 ~~amortized~~and ~~over~~a ~~the~~gain ~~life~~due ofto ~~the~~cancellation ~~note~~of orderivative ~~until~~liabilities ~~the~~as ~~note~~of isdate ~~converted~~of orsettlement ~~repaid~~of $624,490. As of December 31, ~~2022~~2023 and ~~2021~~December 31, ~~this~~2022, ~~note~~respectively, ~~has~~the ~~not~~principal ~~been converted~~ and ~~the~~accrued ~~balance~~interest ofbalances ~~secured~~were ~~convertible notes was~~ $~~610~~822,~~104~~735 and $~~592~~1,~~915~~180,492 respectively, which ~~included~~include accrued interest of $~~110~~22,~~104~~735 and $92304,~~915 accrued interest~~922,840, respectively.

OnDuring ~~June~~the 7,year’s ~~2021~~ended ~~the~~December ~~Company~~31, ~~converted~~2023 ~~$500,000~~and of2022 respectively, the ~~Convertible~~Company ~~Note~~amortized ~~with~~the ~~TL-66-LLC~~debt ~~along~~discount ~~with~~on all the ~~accrued~~notes ~~interest~~ of $82176,~~707~~428, ~~into 2~~$178,~~647~~692,~~464~~ ~~shares~~respectively. As of ~~the~~December ~~Company’s~~31, ~~common~~2023 ~~stock~~and atDecember ~~$0.2201~~31, ~~per~~2022, ~~share~~unamortized ~~which~~debt ~~resulted~~discount inwas a$1,840,929 ~~loss~~and ~~on extinguishment of debt of~~ $1,~~535~~583,~~264~~435, respectively.

On(6) As of December 31, ~~2019~~2022, ~~Sapphire~~the ~~Biotech~~Company owed to the Executive, ~~Inc~~for employment in his capacity as CEO of AXIM, $512,500 of unpaid salary which is overdue and payable immediately. ~~entered~~Executive and AXIM desired to enter into this Agreement in order resolve the Amount Due in a way that preserves the Company’s working capital and incentivizes and retains Executive. Executive agreed to Issuance of Convertible Note ~~Purchase~~as ~~Agreement~~Partial ~~whereas~~Satisfaction of the ~~Company~~Amount ~~issued~~Due. a$250,000 ~~convertible~~of ~~note~~the ~~with~~Amount Due will be paid by issuing to Executive a convertible note, face value of$250,000 (the "Convertible Note") Executive agreed that he shall waive/forfeit $~~190~~50,000 ~~with~~of the Amount Due, leaving a ~~compounding~~remaining ~~interest~~balance ~~rate~~after such waiver of 3%$212,500 ~~per~~($512,500 ~~annum~~minus $250,000 for the ~~interest~~Convertible Note = $262,500 minus $50,000 waiver = $212,500), which shall not be payable ~~annually~~at ~~beginning~~any ontime ~~December~~prior 31to July 1, ~~2020~~2023, ~~until~~and that Executive shall have no right prior to July 1, 2023 to seek payment of the ~~maturity~~remaining ~~date~~balance of ~~December~~the ~~31,~~Amount ~~2034,~~Due. atExecutive ~~which~~further ~~time~~agrees ~~all~~that ~~principal~~if ~~and~~in ~~interest~~the ~~accrued~~reasonable ~~thereon~~discretion ~~shall~~of bethe ~~due~~Board ~~and~~of ~~payable.~~Directors ~~The~~full ~~Convertible~~payment ~~Note~~of isthe ~~secured~~remaining bybalance ~~substantially~~of ~~all~~the Amount Due on July 1, 2023 ($212,500) is too burdensome for the Company’s ~~tangible~~working ~~and~~capital ~~intangible~~position ~~assets.~~at Inthat ~~addition~~time, ~~the~~then ~~Convertible~~Executive ~~Note~~will ~~includes~~either ~~various~~grant ~~non~~an additional 3-~~financial~~month ~~covenants~~extension ~~including~~for the ~~Company~~payment ~~may~~of ~~not~~the remaining Amount Due or engage in good faith discussions with the Board in order to enter into ~~any~~a ~~agreement,~~payment ~~arrangement~~plan for the remaining Amount Due, or ~~understanding~~a combination of ~~any~~ both.

F-23

Table of Contents

~~NOTE~~Payment ~~11:~~of ~~CONVERTIBLE~~Principal ~~NOTES~~and ~~PAYABLE~~Interest. From the date of this Convertible Note (~~CONTINUED~~the “Note” or “Convertible Note”), interest shall be payable annually on the basis of a three hundred sixty (360) day year and compounded on a yearly basis at a rate equal to Four Percent (4%) per annum (the “Interest Rate”). beginning on January 23, 2024 until the maturity date of January 23, 2033, at which time all principal and interest accrued thereon shall be due and payable. Upon issuance, the Convertible Note was convertible into shares of the Company’s common stock at $0.01 per share. At January 23, 2023, the modification date, the Company determined that the Convertible Note contained a beneficial conversion feature for which a full discount was recorded on the Convertible Note. The fair market value of the Company’s common stock was based upon the estimated per share acquisition price per the pending acquisition of the Company. The discount of $250,000 will be amortized using the effective interest method and will be fully amortized by January 23, 2033. This is a new note accounted for by recording the note at face value and a debt discount of $250,000 which will be amortized over the life of the note.

~~kind~~As ~~that~~of ~~would~~December ~~result in a transaction~~31, or2023 ~~series~~and ofDecember ~~transactions~~31, ~~that~~2022 ~~would result in~~ the ~~sale~~balance ofdue ~~50%~~on orthe ~~more~~note ofwas ~~the~~$259,361 ~~Company’s~~and ~~capital~~$-0- ~~stock~~including ~~without~~accrued ~~the~~interest ~~prior~~of ~~approval~~$9,361 ofand ~~the~~$-0- ~~holder~~respectively.

~~Upon issuance, the~~ Convertible ~~Note~~note ~~was~~related ~~convertible~~party into shares of the Company’s common stock at $1.90 per share. At December 31, 2019, the Company determined that the Convertible Note contained a beneficial conversion feature for which a full discount was recorded on the Convertible Note. The fair market value of the Company’s common stock was based upon the estimated per share acquisition price per the pending acquisition of the Company. The discount of $190,000 will be amortized using the effective interest method and will be fully amortized by December 31, 2034.MMI

On(7) ~~March~~The ~~17, 2020 the~~ Company entered into a ~~Share~~Convertible ~~Exchange~~Note Purchase Agreement (“~~Agreement~~CNPA”) with ~~Sapphire~~its

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