UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

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

For the quarterly period ended ~~August~~February 3128, ~~2017~~2018

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

Commission File Number: 000-28385

Protalex, Inc.

(Exact Name of Registrant as Specified in its Charter)

Delaware

91-2003490

(State or Other Jurisdiction of

Incorporation or Organization)

(I.R.S. Employer

Identification Number)

131 Columbia Turnpike, Suite 1

Florham Park, NJ 07932

(Address of Principal Executive Offices and Zip Code)

215-862-9720

(Registrant’s Telephone Number, Including Area Code)

(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 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. x Yes ¨ No

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, 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 he registrant was required to submit and post such files). x Yes ¨ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ¨ Accelerated filer ¨ Non-accelerated filer ¨ (Do not check if a smaller reporting company) Smaller reporting company x Emerging growth company ¨x

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 is a shell company (as defined in Rule 12b-2 of the Exchange Act). ¨ Yes x No

Number of shares outstanding of the issuer’s Common Stock, par value $0.00001 per share, as of ~~October~~April 1113, ~~2017~~2018: 2847,~~767~~325,~~582~~387 shares.

PROTALEX, INC.

Quarterly Report on Form 10-Q

For the Period Ended ~~August~~February 3128, ~~2017~~2018

TABLE OF CONTENTS

		~~Page No.~~	Page No.
PART I.	~~FINANCIAL INFORMATION~~	FINANCIAL INFORMATION
ITEM 1.	~~Financial Statements:~~	Financial Statements:
	Condensed Balance Sheets at August 31, 2017 (Unaudited) and May 31, 2017	3
		Condensed Balance Sheets at February 28, 2018 (Unaudited) and May 31, 2017	3
	Condensed Statements of Operations for the three months ended August 31, 2017 and August 31, 2016 (Unaudited)	4
		Condensed Statements of Operations for the three and nine months ended February 28, 2018 and February 28, 2017 (Unaudited)	4
	Condensed Statements of Cash Flows for the three months ended August 31, 2017 and August 31, 2016 (Unaudited)	5
		Condensed Statement of Stockholders’ (Deficit) for the nine months ended February 28, 2018 (Unaudited)	5
	Notes to Unaudited Condensed Financial Statements	6
		Condensed Statements of Cash Flows for the nine months ended February 28, 2018 and February 28, 2017 (Unaudited)	6
ITEM 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	11
		Notes to Unaudited Condensed Financial Statements	7
ITEM 3.	Quantitative and Qualitative Disclosures About Market Risk	29
ITEM 2.		Management’s Discussion and Analysis of Financial Condition and Results of Operations	12
ITEM 4.	Controls and Procedures	29
ITEM 3.		Quantitative and Qualitative Disclosures About Market Risk	34
PART II.	OTHER INFORMATION
ITEM 4.		Controls and Procedures	34
ITEM 6.	Exhibits	29
PART II.		OTHER INFORMATION
	SIGNATURES	30
ITEM 2.		Unregistered Sales of Equity Securities and Use of Proceeds	34
ITEM 6.		Exhibits	34
		SIGNATURES	35

FORWARD-LOOKING STATEMENTS

Certain statements made in this Quarterly Report on Form 10-Q are “forward-looking statements” regarding the plans and objectives of management for future operations and market trends and expectations. Such statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. The forward-looking statements included herein are based on current expectations that involve numerous risks and uncertainties. Our plans and objectives are based, in part, on assumptions involving the continued expansion of our business. Assumptions relating to the foregoing involve judgments with respect to, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond our control. Although we believe that our assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate and, therefore, there can be no assurance that the forward-looking statements included in this Report will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation by us or any other person that our objectives and plans will be achieved. We undertake no obligation to revise or update publicly any forward-looking statements for any reason. The terms “we”, “our”, “us”, or any derivative thereof, as used herein refer to Protalex, Inc., a Delaware corporation, and its predecessors.

PART I - FINANCIAL INFORMATION

ITEM 1.

FINANCIAL STATEMENTS

PROTALEX, INC.

CONDENSED BALANCE SHEETS

	August 31,			May 31,
	February 28,			May 31,
	2017			2017
	2018			2017
	(Unaudited)
CURRENT ASSETS:
Cash and cash equivalents	$	~~477~~1,~~258~~440,866		$	487,383
Prepaid expenses		58107,~~133~~847			107,209
Total current assets		~~535~~1,~~391~~548,713			594,592
OTHER ASSETS:
Intellectual technology property, net of accumulated amortization of $17,403 and $17,148 as of August 31, 2017 and May 31, 2017, respectively		2,132			2,387
Intellectual technology property, net of accumulated amortization of $17,913 and $17,148 as of February 28, 2018 and May 31, 2017, respectively		1,622			2,387
Total other assets		21,~~132~~622			2,387
Total Assets	$	~~537~~1,~~523~~550,335		$	596,979
LIABILITIES AND STOCKHOLDERS’ (DEFICIT)
CURRENT LIABILITIES:
Accounts payable	$	~~588~~719,~~669~~066		$	489,029
Accrued expenses		3647,~~106~~859			57,786
Total current liabilities		~~624~~766,~~775~~925			546,815
LONG TERM LIABILITIES:
Senior Secured Note – related party		21,169,366			20,299,366
Senior Convertible Debt - net of discount ($1,425,000 face value less Senior Convertible Debt Discount of $1,425,000 at February 28, 2018 and $0 Debt and $0 Discount at May 31, 2017)		0			0
Senior Secured Note Accrued Interest – related party		1,647,977			1,490,416
Senior Secured Note – related party		0			20,299,366
Total liabilities		23,442,118			22,336,597
Senior Secured Note Accrued Interest – related party		1,974,349			1,490,416
Total liabilities		2,741,274			22,336,597
STOCKHOLDERS' (DEFICIT)
Preferred stock, par value $0.00001, 1,000,000 shares authorized; none issued and outstanding		0			0
Common stock, par value $0.00001, 100,000,000 shares authorized; 28,767,582 and 28,767,582 shares issued and outstanding, respectively		288			288
Common stock, par value $0.00001,
Additional paid in capital		77,446,343			77,446,343
100,000,000 shares authorized; 47,325,387 and 28,767,582 shares issued and outstanding, respectively		474			288
Accumulated deficit		(100,351,226	)		(99,186,249	)
Additional paid in capital		101,885,724			77,446,343
Total stockholders’ (deficit)		(22,904,595	)		(21,739,618	)
Accumulated deficit		(103,077,137	)		(99,186,249	)
Total liabilities and stockholders’ (deficit)	$	537,523		$	596,979
Total stockholders’ (deficit)		(1,190,939	)		(21,739,618	)
Total liabilities and stockholders’ (deficit)	$	1,550,335		$	596,979

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

PROTALEX, INC.

CONDENSED STATEMENTS OF OPERATIONS

	Three Months Ended August 31, 2017			Three Months Ended August 31, 2016
	Three Months Ended February 28, 2018			Three Months Ended February 28, 2017			Nine Months Ended February 28, 2018			Nine Months Ended February 28, 2017
	(Unaudited)			(Unaudited)			(Unaudited)			(Unaudited)
Revenues	$	0		$	0		$	0		$	0
Operating Expenses
Research and development		~~681~~536,~~829~~815			~~448~~814,~~981~~002			1,766,693			1,738,842
Administrative		~~142~~867,~~390~~839			~~357~~127,~~936~~616			1,163,517			580,031
Professional fees		~~182~~151,943			~~331~~178,~~907~~588			475,981			724,626
Depreciation and amortization		255			255			765			765
Operating loss		(1,~~007~~556,~~417~~852	)		(1,~~139~~120,~~079~~461	)		(3,406,956	)		(3,044,264	)
Other income (expense)
Interest income		1			1			2			2
Interest expense		(~~157~~164,~~561~~558	)		(~~129~~141,~~340~~400	)		(483,934	)		(406,207	)
Loss before income taxes		(1,~~164~~721,~~977~~409	)		(1,~~268~~261,~~418~~860	)		(3,890,888	)		(3,450,469	)
Provision for income taxes		0			0			0			0
Net loss	$	(1,~~164~~721,~~977~~409	)	$	(1,~~268~~261,~~418~~860	)	$	(3,890,888	)	$	(3,450,469	)
Weighted average number of common shares outstanding		28,~~767~~976,~~582~~097			28,767,582			28,835,809			28,767,582
Loss per common share – basic and diluted	$	(0.0406	)	$	(0.0604	)	$	(0.13	)	$	(0.12	)

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

PROTALEX, INC.

CONDENSED ~~STATEMENTS~~STATEMENT OF ~~CASH FLOWS~~STOCKHOLDERS’ (DEFICIT)

	Three Months			Three Months
	Ended			Ended
	August 31,			August 31,
	2017			2016
	(Unaudited)			(Unaudited)
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(1,164,977	)	$	(1,268,418	)
Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:
Depreciation and amortization		255			255
Equity based expense		0			180,333
(Increase)/decrease in:
Prepaid expenses and deposits		49,076			(16,137	)
Increase/(decrease) in:
Accounts payable and accrued expenses		77,960			(173,116	)
Accrued interest payable		157,561			129,340
Net cash and cash equivalents used in operating activities		(880,125	)		(1,147,743	)
CASH FLOWS FROM INVESTING ACTIVITIES:		0			0
CASH FLOWS FROM FINANCING ACTIVITIES:
Issuance of note payable to individuals		870,000			1,095,000
Net cash and cash equivalents provided by financing activities		870,000			1,095,000
NET DECREASE IN CASH AND CASH EQUIVALENTS		(10,125	)		(52,743	)
Cash and cash equivalents, beginning of period		487,383			444,179
Cash and cash equivalents, ending of period	$	477,258		$	391,436
SUPPLEMENTAL SCHEDULE OF CASH FLOW INFORMATION:
Interest paid	$	0		$	0
Taxes paid	$	0		$	0

For Nine Months Ended February 28, 2018

	Common Stock Shares		Amount		Additional Paid-in Capital		Accumulated Deficit			Total
Balance, May 31, 2017		28,767,582	$	288	$	77,446,343	$	(99,186,249	)	$	(21,739,618	)

Equity based expense		-		-		745,200		-			745,200
Beneficial conversion feature		-		-		1,425,000		-			1,425,000
Debt to Equity		18,557,805		186		22,269,181		-			22,269,367
Net loss		-		-		-		(3,890,888	)		(3,890,888	)
Balance, February 28, 2018 (unaudited)		47,325,387	$	474	$	101,885,724	$	(103,077,137	)	$	(1,190,939	)

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

PROTALEX, INC.

CONDENSED STATEMENTS OF CASH FLOWS

	Nine Months			Nine Months
	Ended			Ended
	February 28,			February 28,
	2018			2017
	(Unaudited)			(Unaudited)
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(3,890,888	)	$	(3,450,469	)
Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:
Depreciation and amortization		765			765
Equity based expense		745,200			180,333
(Increase)/decrease in:
Prepaid expenses and deposits		(638	)		(85,596	)
Increase/(decrease) in:
Accounts payable and accrued expenses		704,044			381,750
Net cash and cash equivalents used in operating activities		(2,441,517	)		(2,973,217	)

CASH FLOWS FROM INVESTING ACTIVITIES:		0			0

CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of Senior Convertible Notes		1,425,000			-
Proceeds from Related Party Senior Secured Notes		1,970,000			3,110,000
Net cash and cash equivalents provided by financing activities		3,395,000			3,110,000

NET INCREASE IN CASH AND CASH EQUIVALENTS		953,483			136,783
Cash and cash equivalents, beginning of period		487,383			444,179
Cash and cash equivalents, ending of period	$	1,440,866		$	580,962

SUPPLEMENTAL SCHEDULE OF CASH FLOW INFORMATION:
Interest paid	$	0		$	0
Taxes paid	$	0		$	0
Conversion of Related Party Senior Secured Notes		22,269,367			-

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

PROTALEX, INC.

NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

NOTE 1. ORGANIZATION AND BUSINESS ACTIVITIES

The Company is focused on the development of a class of biopharmaceutical drugs for treating autoimmune and inflammatory diseases including rheumatoid arthritis (RA) and Immune Thrombocytopenia (ITP). Its lead product, PRTX-100, is a highly-purified form of Staphylococcal protein A, a bacterial protein known to modify aspects of the human immune system.

The Company maintains an administrative office in Florham Park, New Jersey and currently outsources all of its product development and regulatory activities, including clinical trial activities, manufacturing and laboratory operations, to third-party contract research organizations and facilities.

In April 2009, the Company ceased all operations and terminated all employees in light of insufficient funds to continue its clinical trials and related product development. The Company’s business was dormant until new management took control of its operations in November 2009. Since then the Company has been actively pursuing the commercial development of PRTX-100 for the treatment of RA and ITP. In the United States, the Company has open Investigational New Drug (IND) applications for the treatment of RA and ITP and in Europe, an open Investigational Medicinal Products Dossier (IMPD) for ITP.

PRTX-100 has demonstrated effectiveness in animal models of autoimmune diseases as well as demonstrated activity on cultured human immune cells at very low concentrations, although the effectiveness of PRTX-100 shown in pre-clinical studies using animal models may not be predictive of the results of future human clinical trials. The safety, tolerability and pharmakinetics of PRTX-100 in humans have been characterized in six clinical studies and PRTX-100 has been granted Orphan Drug Designation (ODD) in the United States and Europe for the treatment of ITP. The Company does not anticipate generating operating revenue for the foreseeable future and does not currently have any products that are marketable.

NOTE 2. GOING CONCERN

The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, which contemplate continuation of the Company as a going concern. The ability of the Company to continue as a going concern is dependent upon developing products that receive regulatory approval and market acceptance. There is no assurance that these benchmarks will be realized. The financial statements do not include any adjustments that might result from the outcome of these uncertainties.

There is substantial doubt about the Company’s ability to to continue as a going concern. From inception through ~~August~~February 3128, ~~2017~~2018, the Company has incurred an accumulated deficit of $~~100~~103,~~351~~077,~~226~~137. For the years ended May 31, 2017 and 2016, the Company had net losses of $4,563,721 and $9,415,450, respectively, and for the ~~three~~nine months ended ~~August~~February 3128, ~~2017~~2018, the Company had a net loss of $13,~~164~~890,~~977~~888. The Company utilized $3,936,796 and $4,279,100 of cash for operating activities for the years ended May 31, 2017 and 2016, respectively, and $~~880~~2,~~125~~441,517 during the ~~three~~nine months ended ~~August~~February 3128, ~~2017~~2018. As of ~~August~~February 3128, ~~2017~~2018, the Company had cash and cash equivalents of $~~477~~1,~~258~~440,866 and ~~negative~~ net working capital of $89781,~~384~~788. The Company has incurred negative cash flow from operating activities since its inception. The Company has spent, and subject to obtaining additional financing, expects to continue to spend, substantial amounts in connection with executing its business strategy, including continued development efforts relating to PRTX-100.

The Company has no significant payments due on long-term obligations. However, the Company anticipates entering into significant contracts to perform product manufacturing and to conduct clinical trials in the future and that it will need to raise additional capital to fund the ongoing FDA regulatory approval process. If the Company is unable to obtain approval of its future IND applications or otherwise advance the FDA approval process, its ability to sustain its operations would be significantly jeopardized.

The Company will require additional working capital to support its operations. The most likely sources of additional financing include the sale of the Company’s equity or debt securities. On June 3, 2016, the Company filed Amendment #1 to the Registration Statement on Form S-1 with the U.S. Securities and Exchange Commission (SEC) (SEC File No. 333-206008), originally filed on July 31, 2015, with respect to a proposed public offering of Company securities. There is no assurance that ~~the Company will consummate a public offering of its securities, or any other offering. Accordingly,~~ additional capital that is required by the ~~Company~~ ~~may~~Company ~~not~~will be available on reasonable terms, or at all.

6 7

PROTALEX, INC.

NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

NOTE 3. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

The interim financial data contained in this Report is unaudited; however in the opinion of management, the interim data includes all adjustments, consisting of normal recurring adjustments, necessary for a fair statement of the results for the interim period. The financial statements included herein have been prepared by the Company pursuant to the rules and regulations of the SEC. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) have been omitted pursuant to such rules and regulations, although the Company believes that the disclosures included herein are adequate to make the information presented not misleading. The results of operations in interim periods are not necessarily indicative of the results that may be expected for the full year.

Information regarding the organization and business of the Company, accounting policies followed by the Company and other important information is contained in the notes to the Company's financial statements included in the Company's Annual Report on Form 10-K for the fiscal year ended May 31, 2017. This Report should be read in conjunction with the Company’s Annual Report.

Estimates

The preparation of financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions affecting the reported amounts of assets, liabilities, and expense, and the disclosure of contingent assets and liabilities. Estimated amounts could differ from actual results.

Loss per Common Share

The Financial Accounting Standards Board (FASB) has ~~issued~~ issued guidance for “Earnings Per Share” which provides for the calculation of “Basic” and “Diluted” earnings per share. Basic earnings per share includes no dilution and is computed by dividing net loss to common stockholders by the weighted average number of common shares outstanding for the period. All potentially dilutive securities consisting of employee stock options and warrants have been excluded from the computations since they would be antidilutive. However, these dilutive securities could potentially dilute earnings per share in the future. As of ~~August 31~~February 28, ~~2017~~2018 and ~~August~~February 3128, ~~2016~~2017, the Company had potentially dilutive securities consisting of 39,~~980~~316,018 (Senior Convertible Notes of 2,375,475 and 6,940,543 of stock options) and 3,~~982~~980,543 stock options, respectively.

Cash and Cash Equivalents

For the purposes of reporting cash flows, the Company considers all cash accounts which are not subject to withdrawal restrictions or penalties, and highly liquid investments with original maturities of 90 days or less to be cash and cash equivalents. The cash and cash equivalent deposits are not insured by The Federal Deposit Insurance Corporation.

Reclassifications

Certain reclassifications have been made to the prior periods to conform to the current presentations in the financial statements.

Research and Development

Research and development costs are expensed as incurred.

7 8

PROTALEX, INC.

NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

NOTE 3. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)

Share Based Compensation

Effective June 1, 2006, the Company adopted the FASB accounting guidance for fair value recognition provisions of the “Accounting for Share-Based Payment”. This standard requires the Company to measure the cost of employee services received in exchange for equity share options granted based on the grant-date fair value of the options. The cost is recognized as compensation expense over the vesting period of the options. The fair value of compensation costs attributed to equity rights issued was $0745,200 and $180,333 and is included in operating expenses for the ~~three~~ nine months ended ~~August~~February 3128, ~~2017~~2018 and ~~August~~February 3128, ~~2016~~2017, respectively. These amounts included both the compensation cost of stock ~~options~~ options granted prior to but not yet vested as of June 1, 2006 and compensation cost for all options granted subsequent to May 31, 2006. In accordance with the modified prospective application transition method, prior period results are not restated. ~~Incremental~~ Incremental compensation cost for a modification of the terms or conditions of an award is measured by comparing the fair value of the modified award with the fair value of the award immediately before the modification. No tax benefit was recorded as of ~~August 31~~February 28, ~~2017~~2018 in connection with these compensation costs due to the uncertainty regarding ultimate realization of certain net operating loss carryforwards. The Company has also implemented the SEC interpretations in Staff Accounting Bulletin (SAB) for “Share-Based Payments,” in connection with the adoption of FASB accounting guidance.

The accounting guidance requires the use of a valuation model to calculate the fair value of each stock-based award. The Company uses the Black-Scholes model to estimate the fair value of stock options granted based on the following assumptions:

Expected Term or Life. The expected term or life of stock options granted issued represents the expected weighted average period of time from the date of grant to the estimated date that the stock option would be fully exercised. The weighted average expected option term was determined using a combination of the “simplified method” for plain vanilla options as allowed by the accounting guidance. The “simplified method” calculates the expected term as the average of the vesting term and original contractual term of the options.

Expected Volatility. Expected volatility is a measure of the amount by which the Company’s stock price is expected to fluctuate. Expected volatility is based on the historical daily volatility of the price of our common shares. The Company estimated the expected volatility of the stock options at grant date.

Risk-Free Interest Rate. The risk-free interest rate is based on the implied yield on U.S. Treasury zero-coupon issues with remaining terms equivalent to the expected term of our stock-based awards.

At ~~August~~February 3128, ~~2017~~2018, there were 46,~~180~~940,543 ~~stock~~ stock options outstanding, of which 35,~~980~~360,543 were exercisable. At ~~August~~February 3128, ~~2017~~2018, the aggregate unrecognized compensation cost of unvested options, as determined using a Black-Scholes option valuation model, was $0745,200. The ~~remaining~~Company ~~options~~granted ~~will~~2,760,000 bestock ~~valued~~options ~~once~~with ~~they~~an ~~vest~~exercise ~~upon~~price ~~the~~of ~~future events~~$0.54 ~~The~~per ~~Company~~share ~~did not grant any options~~ during the ~~three~~nine months ended ~~August~~February 3128, ~~2017~~ 2018, and 400,000 options expired.

NOTE 4. RECENT ACCOUNTING PRONOUNCEMENTS

Management does not believe that any recently issued, but not yet effective, accounting standards could have a material effect on the accompanying consolidated financial statements. As new accounting pronouncements are issued, the Company will adopt those that are applicable under the circumstances.

In August 2014, the FASB issued Accounting Standards Update “ASU” 2014-15 on “Presentation of Financial Statements Going Concern (Subtopic 205-40) – Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern”. Currently, there is no guidance in U.S. GAAP about management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern or to provide related footnote disclosures. The amendments in this ASU provide that guidance. In doing so, the amendments are intended to reduce diversity in the timing and content of footnote disclosures. The amendments require management to assess an entity’s ability to continue as a going concern by incorporating and expanding upon certain principles that are currently in U.S. auditing standards. Specifically, the amendments (1) provide a definition of the term substantial doubt, (2) require an evaluation every reporting period including interim periods, (3) provide principles for considering the mitigating effect of management’s plans, (4) require certain disclosures when substantial doubt is alleviated as a result of consideration of management’s plans, (5) require an express statement and other disclosures when substantial doubt is not alleviated, and (6) require an assessment for a period of one year after the date that the financial statements are issued (or available to be issued). The amendments in this ASU are effective for public and nonpublic entities for annual periods ending after December 15, 2016. Early adoption is permitted. The Company is currently reviewing the provisions of this ASU to determine if there will be any impact on its results of operations, cash flows or financial condition. The Company does not believe that accounting standards currently adopted will have a material effect on the accompanying financial statements.

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PROTALEX, INC.

NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

NOTE 5. RELATED PARTIES

Niobe Ventures, LLC, a Delaware limited liability company (“Niobe”), the majority stockholder of the Company and the holder of the Consolidated Note (defined in Note 6, below), is controlled by Arnold P. Kling, the Company’s president and a director.

NOTE 6. SENIOR SECURED NOTES - RELATED PARTY

OnAs ~~October~~of 11May 31, ~~2013~~2017, the ~~Company issued~~outstanding aprincipal ~~Consolidated,~~balance ~~Amended~~under ~~and~~the ~~Restated~~Senior ~~Promissory~~Secured ~~Note~~Debt to Niobe intotaled ~~the~~$20,299,366, ~~principal~~including ~~amount of~~ $9,219,366 ~~(the~~under ~~“Consolidated~~a ~~Note”). The~~consolidated ~~face amount of the Consolidated Note reflects the $9.0 million aggregate principal amount of outstanding secured notes then~~note ~~held~~issued byto Niobe ~~(the “Secured Notes”) plus interest accrued at 3% per annum~~ on ~~each~~October ~~note~~11, ~~from~~2013 ~~its~~and ~~respective date of issuance. The terms of the Consolidated Note were identical to the Secured Notes except that: (a) the maturity date was changed to September 1~~$11, ~~2015~~080,000 ~~which~~under ~~was after~~ the ~~latest~~2014 ~~maturity~~Credit ~~date~~Facility ~~of any of the Secured Notes; and (b) it provided for partial mandatory repayment in the event that the Company received aggregate gross proceeds in excess of $7.5 million~~ from aNiobe ~~single or multiple “Liquidity Events” in an amount equal to twenty-five~~ (~~25%) percent of such gross proceeds (~~the “~~Mandatory Prepayment Amount”).~~ 2014 ACredit ~~“Liquidity Event~~Facility” ~~means (a~~) the sale of any of the Company’s equity, or equity-linked, securities, and (b) the receipt of proceeds, directly or indirectly related to a development and/or commercialization relationship entered into with an unaffiliated third party. In the Secured Notes, the entire principal amount of each note was due, at Niobe’s election, upon the consummation of an equity financing of $7.5 million or greater. Consistent with the terms of the Secured Notes and related security agreements entered into, the Company’s obligations under the Consolidated Note are secured by a first priority perfected security interest in all of the Company’s assets pursuant to a Consolidated, Amended and Restated Security Agreement dated October 11, 2013.

On ~~November~~June 41, ~~2014~~2017, the ~~Company~~2014 ~~entered into a new~~ Credit Facility ~~Agreement~~was ~~(the~~amended ~~“2014 Credit Facility Agreement”) pursuant~~ to ~~which~~increase the ~~Company~~funds ~~may~~available ~~borrow~~for uploans to anthe ~~additional~~Company to $513.~~0 Million~~05 ~~from~~million ~~Niobe,~~and into extend the ~~form~~expiration date of such ~~secured~~facility ~~loans, at any time prior~~ to ~~December~~March 31, ~~2015~~2018 (the “~~2014~~Fourth ~~Credit~~Amended ~~Facility~~and Restated Agreement”). Each loan ~~made to the Company by Niobe~~ under the ~~2014~~Fourth ~~Credit~~Amended and ~~Facility~~Restated Agreement ~~has~~will ~~been~~be represented by a senior secured promissory note bearing interest at a rate of 3% per annum which matures on ~~September~~March 131, ~~2016~~2018 (each ana “~~Original~~2018 Note”). The ~~obligations of~~Security ~~the~~Agreement ~~Company~~was ~~pursuant~~also toamended ~~each~~and ~~Original~~restated to ~~Note~~also ~~have~~secure ~~been~~the ~~secured~~Company’s byobligations aunder ~~first priority perfected security interest in~~ all of2018 ~~the~~Notes ~~assets of~~issued ~~the Company~~ pursuant to the ~~Second~~Fourth ~~Consolidated,~~ Amended and Restated ~~Security Agreement between the Company and Niobe, entered~~ ~~into at the same time as the 2014 Credit Facility~~ Agreement ~~(the “Security Agreement”)~~.

InOn ~~addition,~~August ~~on November 4~~22, ~~2014~~2017, the Company ~~entered~~and ~~into~~Niobe aagreed ~~Note~~to ~~Modification~~extend ~~Agreement (~~the ~~“Note~~maturity ~~Modification~~date ~~Agreement”)~~of ~~with~~all ~~Niobe~~outstanding ~~pursuant~~notes toissued ~~which the Consolidated Note was further amended~~ to ~~increase~~Niobe ~~the threshold amount requiring a Mandatory Prepayment~~ from ~~$7.5~~the ~~Million~~current tomaturity ~~more~~date ~~than~~of ~~$10~~March ~~Million. As a result~~31, ~~partial~~2018 ~~prepayment~~to ~~will now be triggered in the event of~~ a ~~Liquidity Event in which the Company receives gross proceeds~~new inmaturity ~~excess~~date of ~~$10~~September ~~million.~~1, 2018. All other terms and provisions of ~~the~~such ~~Consolidated~~notes ~~Note~~ remained unchanged and in full force and effect.

OnDuring ~~December 1, 2015,~~ the ~~2014~~nine ~~Credit~~months ~~Facility was~~ended ~~amended~~February to28, ~~increase~~ 2018, the ~~funds available for loans to the~~ Company toborrowed ~~$7.5~~an ~~million~~aggregate ~~and to extend the expiration date~~ of ~~such credit~~$1,970,000; ~~facility~~$290,000 toon ~~December~~June 3115, ~~2016~~2017, ~~pursuant~~$290,000 toon ~~which~~July ~~the~~10, ~~Company~~2017, ~~and~~$290,000 ~~Niobe~~on ~~entered~~August ~~into~~10, ~~and an Amended and Restated 2014 Credit~~2017, ~~Facility~~$290,000 ~~Agreement~~on ~~(the~~September ~~“Amended~~15, ~~and~~2017, ~~Restated~~$290,000 ~~Agreement”).~~on ~~Each~~October ~~loan~~23, ~~under~~2017, ~~the~~$200,000 ~~Amended~~on ~~and~~November ~~Restated~~17, ~~Agreement~~2017, ~~has~~$220,000 ~~been and~~on ~~will~~December be15, ~~represented~~2017 ~~by a senior secured promissory note bearing interest at a rate of 3% per annum which matures on September~~and 1$100,000 ~~2017~~on ~~(each~~January a12, ~~“New Note”)~~2018. InPrior ~~addition,~~to the ~~Security~~Offering ~~Agreement~~described ~~was~~below, ~~also~~the ~~amended~~outstanding ~~and~~principal ~~restated~~balance ~~to secure the Company’s obligations~~ under ~~all~~ the ~~Original~~2014 ~~Notes~~Credit ~~and~~Facility totaled ~~all the New Notes~~$13,050,000.

On ~~June~~February 3028, ~~2016~~2018, the ~~2014~~Company ~~Credit~~raised ~~Facility~~an ~~was~~aggregate ~~again~~of ~~amended~~$1.425 tomillion ~~increase~~from ~~the~~eight ~~funds~~accredited ~~available~~investors ~~for~~in ~~loans~~a toprivate ~~the~~placement ~~Company~~financing ~~to $9.0 million~~ (the “~~Second Amended and Restated Agreement~~Offering”). ~~Each~~of 10% ~~loan~~Senior ~~under~~Convertible ~~the~~Notes, ~~Second~~due ~~Amended~~on ~~and~~February ~~Restated~~28, ~~Agreement~~2023 ~~has~~(the ~~been~~“Senior ~~represented~~Notes”). byNo acommissions ~~New~~were ~~Note.~~payable Inin connection ~~addition,~~with the ~~Security~~ ~~Agreement~~Offering which was ~~also~~principally ~~amended~~sold ~~and~~to ~~restated~~existing tostockholders ~~secure~~of the Company’s. ~~obligations~~Proceeds ~~under~~of ~~all~~ the ~~notes~~Offering will ~~issued~~be ~~and~~used ~~outstanding under~~for ~~the~~working ~~2014~~capital ~~Credit~~purposes, ~~Facility~~principally asto offund ~~June~~ongoing ~~30,~~clinical ~~2016~~trials and ~~all~~studies ~~the~~and ~~New~~related ~~Notes~~activities. ~~issued~~No registration ~~pursuant~~rights were granted to the ~~Second~~investors ~~Amended~~in ~~and~~the ~~Restated Agreement~~Offering.

9 The Senior Notes are convertible into shares of Common Stock (defined below) at a price of $0.20 per share at the option of the holder prior to maturity or earlier prepayment, accrue interest at the rate of 10% per annum and are due on February 28, 2023. Upon conversion, the note holder will receive 5,000 shares of the Company’s common stock, par value $.00001 per share (“Common Stock”) for each $1,000 of principal or accrued interest converted. Two-thirds of the shares issuable upon any conversion of the Senior Notes will be acquired by the Company from Niobe for nominal consideration ($.01 per share) pursuant to a mandatory call agreement, entered into in connection with the Offering (the “Call Agreement”). As a result, for each $1,000 of principal or interest converted, the Company will issue approximately 1,667 new shares. Accordingly, the effective conversion price for the Company will be approximately $0.60 per share of Common Stock, with Niobe incurring substantially all of the associated dilution. The closing price of per share of Common Stock on the date of the Offering was $0.45.

PROTALEX, INC.

NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

NOTE 6. SENIOR SECURED NOTES - RELATED PARTY (Continued)

OnThe ~~August~~Company ~~31,~~evaluated ~~2016,~~the conversion feature of the ~~Company~~Senior Notes and ~~Niobe~~determined ~~agreed~~that tounder ~~extend~~ the accounting guidance for “Accounting for Convertible Securities with Beneficial Conversion ~~maturity~~Features” ~~date~~that ofa ~~the~~value ~~Consolidated~~should ~~Note~~be ~~and~~attributed to the ~~maturity~~embedded ~~dates~~conversion offeature. ~~all~~On ~~thirteen~~February ~~outstanding~~28, ~~Original~~2018, the date of issuance of the Senior Notes, ~~with~~the anfair ~~aggregate~~market ~~principal amount~~value of Common Stock was $~~5,030,000,~~0.45 ~~from~~per ~~September~~share. 1,The ~~2016~~Company determined the allocation to ~~September~~the 1,conversion feature ~~2017~~to be $1.425 ~~All~~million, ~~other~~which ~~terms~~reduced ~~and~~the ~~provisions~~face amount of the ~~Consolidated~~Senior ~~Note~~Notes ~~and~~carried on the Company’s balance sheet to ~~Original~~-$0-. ~~Notes~~This ~~remained~~discount ~~unchanged~~will ~~and~~be inamortized ~~full~~over ~~force~~60 months and ~~effect~~will serve to increase the interest expense of the Senior Notes during the term of such notes.

OnIn ~~October 31~~addition, ~~2016,~~as ~~the~~a ~~2014~~condition ~~Credit Facility~~to ~~was~~the ~~amended~~consummation toof ~~increase~~ the ~~funds~~Offering, ~~available~~on ~~for~~February ~~loans~~28, to2018 the Company ~~to $11.25 million~~ and toNiobe ~~extend~~entered ~~the~~into ~~expiration~~an ~~date~~Exchange ~~of such~~Agreement ~~facility to June 15, 2017~~ (the “~~Third~~Exchange ~~Amended and Restated~~ Agreement”). ~~Each~~pursuant ~~loan~~to ~~under~~which ~~the~~Niobe ~~Third~~converted ~~Amended~~$22,269,366 ~~and~~of ~~Restated Agreement~~outstanding ~~will~~notes bedue ~~represented~~September by30, 2018 a(the ~~senior~~aggregate ~~secured~~outstanding ~~promissory~~principal ~~note~~balance ~~bearing~~under ~~interest~~the atSenior aSecured ~~rate~~Debt ofto 3%Niobe ~~per~~as ~~annum~~of ~~which~~February ~~matures~~28, on2018) ~~March~~into 3118,557,805 ~~2018~~shares ~~(each~~of aCommon ~~“2018~~Stock ~~Note”).~~at ~~The~~a ~~Security~~conversion ~~Agreement~~price ~~was~~of ~~also~~$1.20 ~~amended~~per ~~and~~share. ~~restated~~Consequently, toother ~~secure~~than the ~~Company’s~~Senior ~~obligations under~~Notes ~~all the notes~~ issued in ~~under~~ the ~~2014 Credit Facility as of October 31~~Offering, ~~2016 and all~~ the ~~2018~~only ~~Notes.~~remaining Inindebtedness ~~addition,~~on the Company ~~and~~’s ~~Niobe~~balance ~~also~~sheet ~~agreed~~at toFebruary ~~extend~~28, to2018 ~~March~~is 31approximately $1, ~~2018~~974,000, ~~the~~representing ~~maturity dates of~~ the ~~Consolidated~~accrued ~~Note~~but ~~and~~unpaid ~~all~~interest on the notes ~~issued~~converted ~~and~~by ~~outstanding under the 2014 Credit Facility as of October 31, 2016~~Niobe.

AsThe foregoing purchases of ~~May~~securities ~~31,~~were for ~~2017,~~investment ~~the~~and ~~outstanding~~not ~~principal~~with ~~balance under~~a ~~the~~view ~~2014~~for ~~Credit~~distribution. ~~Facility~~The ~~totaled~~securities ~~$11,080,000.~~were ~~During~~issued ~~the~~without ~~year~~registration ~~ended~~under ~~May~~the 31Securities Act of 1933, ~~2017~~as amended, pursuant to the ~~Company~~exemptions ~~borrowed~~provided anunder ~~aggregate~~Sections 4(a)(2) and 4(a)(5) thereof. All of the securities issued $3are restricted securities,~~980,000~~ bear a restrictive legend and will be subject to stop transfer restrictions.

On June 1, 2017, the 2014 Credit Facility was amended to increase the funds available for loans to the Company to $13.05 million and to extend the expiration date of such facility to March 31, 2018 (the “Fourth Amended and Restated Agreement”). Each loan under the Fourth Amended and Restated Agreement will be represented by a 2018 Note. The Security Agreement was also amended and restated to also secure the Company’s obligations under all 2018 Notes issued pursuant to the Fourth Amended and Restated Agreement.

On June 15, 2017, July 10, 2017 and August 10, 2017, the Company borrowed $290,000, $290,000 and $290,000, respectively, under the 2014 Credit Facility pursuant to the Fourth Amended and Restated Agreement and issued Niobe a new 2018 Note for each borrowing in the same principal amount of each loan.

On August 22, 2017, the Company and Niobe agreed to extend the maturity date of all outstanding notes issued to Niobe from the current maturity date of March 31, 2018 to a new maturity date of September 1, 2018. All other terms and provisions of such notes remained unchanged and in full force and effect.

As of August 31, 2017, the outstanding principal balance under the 2014 Credit Facility totaled $11,950,000. During the three months ended August 31, 2017, the Company borrowed an aggregate of $870,000; $290,000 on June 15, 2017, $290,000 on July 10, 2017, and $290,000 on August 10, 2017. Payment of the principal and accrued interest on all outstanding notes issued under the 2014 Credit Facility will, at Niobe’s election, automatically become immediately due and payable if the Company undertakes certain Fundamental Transactions or upon an Event of Default, both as defined in such notes. The Company’s obligations under all such notes are secured by the Security Agreement, as amended.

NOTE 7. SUBSEQUENT EVENTS

On ~~September~~March 1513, ~~2017~~2018, the Company ~~borrowed~~raised an additional $~~290~~50,000 ~~under~~in the ~~terms~~Offering ofand issued a Senior Note in the ~~Fourth~~principal ~~Amended~~amount ~~and~~of ~~Restated~~$50,000 ~~Agreement~~to an accredited investor. In connection with ~~and~~the ~~issued~~foregoing, ~~Niobe~~on aMarch 13, 2018, ~~Note~~the ~~with~~Call aAgreement ~~maturity~~was ~~date~~amended ofand ~~September~~restated 1,to ~~2018~~also ~~for~~include two-thirds of the ~~loan~~shares inissuable upon the ~~same~~conversion ~~principal~~of ~~amount~~this Senior Note.

The Company has evaluated all other subsequent events and has determined that there were no other subsequent events to recognize or disclose in these financial statements.

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Overview

We are focused on the development of a class of biopharmaceutical drugs for treating autoimmune and inflammatory diseases including rheumatoid arthritis (RA) and Immune Thrombocytopenia (ITP). Our lead product candidate, PRTX-100, a new generation immunomodulatory therapy, is a highly-purified form of Staphylococcal protein A, which is a bacterial protein known to modify aspects of the human immune system. PRTX-100 has demonstrated effectiveness in animal models of autoimmune diseases and has demonstrated activity on cultured human immune cells at very low concentrations, although the effectiveness of PRTX-100 shown in pre-clinical studies using animal models may not be predictive of the results that we would see in future human clinical trials. The safety, tolerability and pharmacokinetics (PK) of PTRX-100 in humans have now been characterized in six clinical studies and was granted Orphan Drug Designation (ODD) in the United States and Europe for the treatment of ITP.

In March 2015, the FDA accepted our Investigational New Drug (IND) application for a Phase I/II open-label, dose-escalating study of PRTX-100 in adults with persistent/chronic ITP (the “PRTX-100-202 Study”). In June 2015, the U.S. Food and Drug Administration (FDA) granted ODD to PRTX-100 for the treatment of ITP. In July 2015, the European Medicines Agency (EMA) granted approval for a Phase 1b open-label, dose-escalating study of PRTX-100 in adult patients with persistent/chronic ITP (the “PRTX-100-203 Study”). In September 2015, the EMA Committee for Orphan Medicinal Products (COMP) issued a positive opinion recommending PRTX-100 for designation as an orphan medicinal product for the treatment of ITP. In November 2015, we enrolled our first patient in the PRTX-100-202 Study in the United States and in January 2016 we enrolled our first patient in the PRTX-100-203 Study in Europe. Enrollment is currently continuing in both studies in the third cohorts at an increased dose. In August 2017, the FDA’s Office of Orphan Product Development (OOPD) awarded us a grant of $403,000 to support the future clinical development of PRTX-100 as a treatment for ITP. We do not anticipate generating operating revenue for the foreseeable future and do not currently have any products that are marketable.

In August 2010, we commenced a multi-center Phase 1b clinical trial of PRTX-100 in South Africa in adult patients with active RA on methotrexate or leflunomide (the “PRTX-100-103 Study”). In January 2012, we completed patient dosing in the PRTX-100-103 Study with a total of 37 patients enrolled in four cohorts ranging from 0.15 micrograms/kg to 1.50 micrograms/kg of PRTX-100 or placebo, administered weekly for four weeks. Measures of safety, PK and disease activity were evaluated over 16 weeks following the first dose. The PRTX-100-103 Study results demonstrated that PRTX-100 was generally safe and well-tolerated in patients with active RA at all tested dose levels.

In November 2012, we commenced enrollment in the United States for a new multicenter Phase 1b randomized, multiple-dose, dose-escalation study (the “PRTX-100-104 Study”) of PRTX-100 in combination with methotrexate or leflunomide in adult patients with active RA. The sequential dose-escalation phase of this study was expected to enroll patients into five cohorts ranging from 1.50 micrograms/kg up to 18.0 micrograms/kg of PRTX-100 or placebo. At each dose, one quarter of patients would receive a placebo treatment. Similar to the PRTX-100-103 Study, the primary objective of the PRTX-100-104 Study was to assess the safety and tolerability of intravenous PRTX-100 administered weekly over five weeks in patients with active RA on methotrexate or leflunomide therapy. The secondary objectives included determining the effects of PRTX-100 on measures of disease activity, assessing the immunogenicity and evaluating the PK parameters after repeated doses, and determining possible relationships between the immunogenicity of PRTX-100 and safety and PK.

In August 2013, upon completion of the fourth cohort, we expanded the 3.0 microgram, 6.0 microgram, and 12.0 micrograms/kg dose cohorts of the PRTX-100-104 Study. An additional nine patients were enrolled in the expansion cohort that was completed in October 2013. In total, the first four dose-escalating cohorts of the PRTX-100-104 Study, which included these three expanded cohorts, enrolled 41 patients with doses ranging from 1.5 micrograms/kg up to 12.0 micrograms/kg.

In November 2013, we initiated enrollment of the fifth and final cohort (Cohort 5) in the PRTX 100-104 Study. The Cohort 5 sub-study enrolled 20 patients who received five weekly fixed-weight doses of PRTX-100 followed by up to four additional monthly maintenance doses of PRTX-100 in weeks 8, 12, 16, and 20. The primary objective of the Cohort 5 sub-study was to assess safety and tolerability of these doses administered on a modified schedule. In total, 11 out of 20 patients in Cohort 5 completed all study visits by August 2014 per protocol.

In the Cohort 5 sub-study, the amount of PRTX-100 administered and its dosing frequency were varied from Cohorts 1 through 4 to explore effects on safety, tolerability and measures of disease activity. The addition of four monthly maintenance doses after the five weekly doses did not increase the rate or type of Adverse Event (AE), even in those patients who developed anti-drug antibodies (ADAs), nor indicate any apparent correlation between the development of ADAs and effects on measures of RA disease activity. In addition, Cohort 5 patients showed improvement in measures of disease activity, including ACR20 scores, compared to Cohort 1 through 4 patients who did not receive any monthly maintenance doses, suggesting that the addition of monthly maintenance administration of PRTX-100 and weight-based dosing were an important aspect of the dosing protocol and should be considered in future trials of PRTX-100.

AITEM ~~total of 61 patients enrolled across five cohorts in the PRTX 100-104 Study at nine study sites in the United States~~2. ~~For~~MANAGEMENT’S ~~patients~~DISCUSSION inAND ~~all~~ANALYSIS ~~five~~OF ~~cohorts,~~FINANCIAL ~~PRTX-100~~CONDITION ~~appeared safe~~AND ~~and~~RESULTS ~~well~~OF ~~tolerated in all individuals, including those who developed ADAs, and the AE profile was consistent with our prior clinical trial results.~~OPERATIONS

In February 2015, we commenced enrollment, at a single U.S. site, of a Phase I/II open-label, multiple, fixed-dose study (the “PRTX-100-105 Study”) which was open only to PRTX-100-104 Study patients who indicated their desire for additional treatment. The PRTX-100-105 Study was an open-label, single group study with former participants from the 104 Study who were eligible to receive a fixed dose of PRTX-100 over a 6-month period. The primary study endpoint of the 105 Study was the safety and tolerability of a fixed dose of PRTX-100 administered over an extended period. The secondary endpoints included immunogenicity, effects on measures of RA disease activity, evaluation of anti-PRTX-100 antibody presence, and feasibility of joint evaluations with ultrasound and biomarkers as disease markers. A total of eight patients completed all 105 Study visits per protocol.Overview

InWe are focused on the ~~PRTX-100-105~~development ~~Study,~~of a ~~preliminary~~class ~~interim~~of ~~analysis~~biopharmaceutical ~~indicated~~drugs ~~that~~ for ~~patients~~treating ~~who~~autoimmune ~~completed~~and ~~per~~inflammatory ~~protocol~~diseases including rheumatoid arthritis (RA) and Immune Thrombocytopenia (ITP). Our lead product candidate, PRTX-100, ~~exhibited~~a annew ~~acceptable~~generation ~~safety~~immunomodulatory ~~profile~~therapy, ~~and~~is ~~RA disease~~a ~~activity~~highly-purified ~~was~~form ~~improved~~of inStaphylococcal protein A, which is a ~~majority~~bacterial ofprotein ~~patients~~known atto ~~the~~modify ~~end~~aspects of the ~~study~~human asimmune ~~compared to baseline~~system. NoPRTX-100 ~~serious~~has ~~adverse~~demonstrated ~~events~~effectiveness ~~(SAEs)~~in ~~were~~animal ~~reported.~~models Atof ~~study~~autoimmune ~~day~~diseases ~~196,~~and ~~one~~has ~~month~~demonstrated ~~after~~activity ~~the~~on ~~final~~cultured ~~dose,~~human ~~patients~~immune ~~who~~cells ~~completed~~at very low concentrations, although the ~~study~~effectiveness ~~per~~of ~~protocol~~PRTX-100 ~~demonstrated a~~shown ~~mean~~in ~~reduction~~pre-clinical ofstudies ~~the~~using ~~DAS28CRP~~animal ~~score~~models ~~from~~may ~~5.25~~not tobe ~~2.52,~~predictive ~~suggesting~~of athe ~~clinically~~results ~~meaningful~~that we ~~improvement~~would see in ~~disease~~future ~~activity.~~human ~~Additionally,~~ clinical ~~assessment~~trials. byThe ~~Ultrasound~~safety, ~~Power~~tolerability ~~Doppler~~and ~~Joint~~pharmacokinetics ~~Counts~~ (~~UPD~~PK), ~~also~~of ~~revealed~~PTRX-100 ain ~~reduction~~humans inhave ~~average~~now been ~~disease~~characterized ~~severity~~in bysix ~~day 196,~~clinical studies and ~~the~~was ~~correlation~~granted ~~between~~Orphan Drug Designation (ODD) in the ~~UPD~~United States and ~~the~~Europe ~~DAS28CRP~~for ~~was~~the treatment ~~r=0.624~~of ~~(p<~~ITP.~~0005).~~

In ~~November~~March 2015, wethe ~~commenced enrollment~~FDA ~~and~~accepted ~~enrolled~~ our ~~first~~Investigational ~~patient~~New Drug (IND) application for a Phase I/II open-label, dose-escalating study of PRTX-100 in adults with persistent/chronic ITP (the “PRTX-100-202 Study”). ~~The~~In June 2015, the U.S. Food and Drug Administration (FDA) granted ODD to PRTX-100~~-202~~ ~~Study~~for ~~may~~the ~~enroll~~treatment upof toITP. 36In ~~patients~~July in2015, asthe ~~many~~European asMedicines ~~six~~Agency (EMA) ~~cohorts.~~granted ~~Each~~approval ~~patient~~for ~~will~~a ~~receive~~Phase ~~four~~1b ~~weekly~~open-label, ~~intravenous~~dose-escalating ~~doses~~study of PRTX-100 ~~and~~in ~~will~~adult bepatients ~~monitored~~with persistent/chronic ITP (the “PRTX-100-203 Study”). In September 2015, the EMA Committee for upOrphan toMedicinal 48Products ~~weeks~~(COMP) ~~thereafter.~~issued a ~~The~~positive ~~primary~~opinion ~~study~~recommending ~~endpoint~~PRTX-100 for designation as an orphan medicinal product for the treatment of ITP. In November 2015, we enrolled our first patient in the PRTX-100-202 Study isin athe ~~platelet~~United ~~response~~States toand in January 2016 we enrolled our first patient in the PRTX-100.-203 ~~Secondary~~Study ~~endpoints~~in ~~include~~Europe. ~~safety,~~Enrollment ~~immunogenicity, and~~is ~~pharmacokinetics.~~continuing ~~One~~in ~~patient~~the PRTX-100-202 Study in ~~each~~the ofU.S. and the ~~two~~United Kingdom ~~completed~~(UK) ~~cohorts~~and ofin the PRTX-100-~~202~~203 Study ~~had~~in athe ~~platelet~~UK. ~~response~~In ~~per~~August ~~protocol.~~2017, ~~Enrollment~~the isFDA’s ~~continuing~~Office ~~for~~of ~~patients~~Orphan inProduct ~~the~~Development ~~third~~(OOPD) ~~cohort~~awarded inus a grant of $403,000 to support the future clinical development of PRTX-100~~-202~~ ~~Study~~as ata antreatment ~~increased~~for ~~dose~~ITP. We do not anticipate generating operating revenue for the foreseeable future and do not currently have any products that are marketable.

In ~~January~~August ~~2016~~2010, we commenced ~~enrollment~~a multi-center ofPhase ~~our~~1b ~~first~~clinical ~~patient~~trial inof ~~the European based~~ PRTX-100~~-203~~ ~~Study.~~in ~~The~~South ~~PRTX-100-203~~Africa ~~Study~~in ~~may~~adult ~~enroll up to 30~~ patients inwith asactive ~~many~~RA ~~as five~~on ~~cohorts.~~methotrexate ~~Each~~or ~~patient~~leflunomide ~~will~~(the ~~receive four weekly intravenous doses of~~ “PRTX-100-103 Study”). ~~and~~In ~~will~~January be2012, ~~monitored~~we ~~for~~completed uppatient todosing 48in ~~weeks thereafter. The primary study endpoints of~~ the PRTX-100-~~203~~103 Study ~~include~~with ~~safety,~~a ~~immunogenicity~~total ~~and~~of ~~pharmacokinetics.~~37 ~~Secondary~~patients ~~endpoints include~~enrolled ~~platelet~~in ~~response~~four cohorts ~~and~~ranging ~~duration~~from 0.15 ~~One~~micrograms/kg ~~patient~~to in1.50 ~~the~~micrograms/kg ~~first cohort~~ of ~~the~~ PRTX-100~~-203~~ ~~Study~~or ~~had~~placebo, aadministered ~~platelet~~weekly ~~response~~for ~~per~~four ~~protocol~~weeks. Measures Inof ~~addition~~safety, wePK ~~recently~~and ~~opened~~disease ~~seven~~activity ~~new~~were ~~clinical~~evaluated ~~study~~over ~~sites~~16 inweeks ~~the~~following ~~United Kingdom and dosed~~ the first ~~patient~~dose. ~~Enrollment~~The isPRTX-100-103 Study results demonstrated ~~continuing~~that ~~for~~PRTX-100 ~~patients~~was ingenerally ~~the~~safe ~~third~~and ~~cohort~~well-tolerated in ~~the~~patients ~~PRTX-100-203~~with ~~Study~~active RA at anall ~~increased~~tested dose levels.

WeIn ~~maintain~~November an2012, ~~administrative~~we ~~office~~commenced inenrollment ~~Florham~~in ~~Park~~the United States for a new multicenter Phase 1b randomized, ~~New~~multiple-dose, ~~Jersey~~dose-escalation ~~and~~study ~~currently~~(the ~~outsource~~“PRTX-100-104 ~~all~~Study”) of PRTX-100 in combination with methotrexate or leflunomide in adult patients with active RA. The sequential dose-escalation phase of ~~our~~this ~~product~~study ~~development~~was ~~and~~expected ~~regulatory~~to ~~activities~~enroll patients into five cohorts ranging from 1.50 micrograms/kg up to 18.0 micrograms/kg of PRTX-100 or placebo. At each dose, ~~including~~one ~~clinical~~quarter ~~trial~~of ~~activities~~patients would receive a placebo treatment. Similar to the PRTX-100-103 Study, the primary ~~manufacturing~~objective ~~and~~of ~~laboratory~~the ~~operations,~~PRTX-100-104 Study was to ~~third~~assess the safety and tolerability of intravenous PRTX-~~party~~100 ~~contract~~administered ~~research~~weekly ~~organizations~~over five weeks in patients with active RA on methotrexate or leflunomide therapy. The secondary objectives included determining the effects of PRTX-100 on measures of disease activity, ~~consultants~~assessing the immunogenicity and ~~facilities~~evaluating the PK parameters after repeated doses, and determining possible relationships between the immunogenicity of PRTX-100 and safety and PK.

In ~~April~~August ~~2009~~2013, ~~under~~upon ~~prior~~completion ~~management,~~of the fourth cohort, we ~~ceased~~expanded ~~all~~the ~~operations~~3.0 ~~and~~microgram, ~~terminated~~6.0 ~~all~~microgram, ~~employees~~and in12.0 ~~light~~micrograms/kg dose cohorts of ~~insufficient~~the ~~funds~~PRTX-100-104 toStudy. ~~continue~~An ~~our~~additional nine ~~clinical~~patients ~~trials~~were ~~and~~enrolled ~~related product~~in ~~development.~~the ~~Our~~expansion ~~business~~cohort that was ~~dormant~~completed ~~until~~in ~~current~~October ~~management~~2013. ~~took~~In ~~control~~total, the first four dose-escalating cohorts of ~~our~~the ~~operations~~PRTX-100-104 inStudy, ~~November~~which ~~2009~~included ~~following the~~these ~~change~~three inexpanded ~~control~~cohorts, ~~transaction~~enrolled ~~more~~41 ~~fully~~patients ~~described~~with ~~below~~doses ranging from 1.5 micrograms/kg up to 12.0 micrograms/kg.

~~Change~~In November 2013, we initiated enrollment of the fifth and final cohort (Cohort 5) in ~~Control~~the PRTX 100-104 Study. The Cohort 5 sub-study enrolled 20 patients who received five weekly fixed-weight doses of PRTX-100 followed by up to four additional monthly maintenance doses of PRTX-100 in weeks 8, 12, 16, and ~~Incremental~~20. ~~Financing~~The ~~Transactions~~primary objective of the Cohort 5 sub-study was to assess safety and tolerability of these doses administered on a modified schedule. In total, 11 out of 20 patients in Cohort 5 completed all study visits by August 2014 per protocol.

On November 11, 2009 (the “Effective Date”), we consummated a financing transaction (the “Financing”) in which we raised $3,000,000 of working capital pursuant to a Securities Purchase Agreement (the “Purchase Agreement”) with Niobe Ventures, LLC, a Delaware limited liability company (“Niobe”). Pursuant to the Purchase Agreement, we issued to Niobe (i) 8,695,652 restricted shares of our common stock at a purchase price of $0.23 per share (or $2 million in the aggregate) and (ii) a senior secured convertible promissory note in the principal amount of $1 million convertible into shares of our common stock at an initial conversion price equal to $0.23 per share (the “$1 Million Secured Note”). On February 11, 2011, Niobe converted the $1 Million Secured Note, including $37,500 of accrued interest thereon, into 4,510,870 shares of common stock.12

AsIn ~~contemplated by~~ the ~~Purchase~~Cohort ~~Agreement~~5 sub-study, ~~all~~ ofthe ~~our~~amount ~~executive~~of ~~officers~~PRTX-100 administered and ~~all~~its ofdosing ~~the~~frequency ~~members~~were ofvaried ~~our~~from ~~Board~~Cohorts of1 ~~Directors~~through ~~(the~~4 ~~“Board”) prior~~ to ~~the~~explore ~~closing~~effects ~~of the~~on ~~Financing~~safety, ~~with~~tolerability ~~the~~and ~~exception~~ measures of ~~Frank~~disease Mactivity. ~~Dougherty,~~The ~~resigned~~addition ~~effective~~of ~~concurrently~~four ~~with~~monthly ~~the~~maintenance ~~closing~~doses ofafter the ~~Financing. Mr. Dougherty~~five ~~resigned~~weekly ~~effective~~doses ~~upon~~did not increase the ~~expiration~~rate or type of ~~the~~Adverse ~~10-day~~Event ~~notice~~(AE), ~~period~~even ~~required~~in bythose ~~Rule~~patients ~~14f~~who developed anti-1drug ~~under~~antibodies ~~the~~(ADAs), ~~Securities~~nor ~~Exchange~~indicate any apparent correlation ~~Act~~between the development of ~~1934,~~ADAs asand ~~amended~~effects ~~(the~~on ~~“Exchange~~measures ~~Act”)~~of RA disease activity. In addition, ~~effective~~Cohort ~~upon~~5 ~~the~~patients ~~closing~~showed improvement in measures of ~~the~~disease ~~Financing~~activity, ~~our~~ ~~Board~~including ~~appointed~~ACR20 ~~Arnold~~scores, P.compared ~~Kling~~to asCohort a1 ~~director~~through ~~and~~4 ~~then~~patients ~~elected~~who ~~him~~did asnot ~~our~~receive ~~president~~any ~~and~~monthly maintenance ~~elected~~doses, ~~Kirk~~suggesting M.that ~~Warshaw~~the asaddition ~~our~~of ~~chief~~monthly maintenance administration of PRTX-100 and weight-based dosing were ~~financial~~an ~~officer~~important aspect of the dosing protocol and ~~secretary~~should be considered in future trials of PRTX-100.

12 A total of 61 patients enrolled across five cohorts in the PRTX 100-104 Study at nine study sites in the United States. For patients in all five cohorts, PRTX-100 appeared safe and well tolerated in all individuals, including those who developed ADAs, and the AE profile was consistent with our prior clinical trial results.

OnIn February 112015, ~~2011,~~we ~~for~~commenced ~~the purpose of~~enrollment, ~~providing~~at usa ~~with~~single ~~additional~~U.S. ~~working capital~~site, ~~pursuant~~of toa anPhase ~~existing~~I/II ~~Credit~~open-label, ~~Facility Agreement dated as of December 2~~multiple, ~~2009~~fixed-dose study (the “~~Facility~~PRTX-100-105 Study”) ~~with~~which ~~Niobe,~~was open weonly ~~issued~~ to ~~Niobe~~PRTX-100-104 aStudy ~~senior~~patients ~~secured~~who ~~convertible~~indicated ~~promissory~~their ~~note~~desire infor ~~the~~additional ~~principal~~treatment. ~~amount~~The ofPRTX-100-105 Study was an open-label, $2single ~~million~~group ~~(the~~study ~~“$2~~with ~~Million~~former ~~Secured~~participants ~~Convertible~~from ~~Note”).~~the ~~The~~104 $2Study ~~Million~~who ~~Secured~~were ~~Convertible~~eligible ~~Note~~to ~~provided~~receive ~~for~~a ~~conversion into~~fixed ~~shares~~dose of ~~our~~PRTX-100 ~~common~~over ~~stock~~a at6-month period. aThe ~~conversion~~primary ~~price~~study endpoint of ~~$0.23~~the ~~per~~105 ~~share,~~Study ~~for~~was anthe ~~aggregate~~safety ofand ~~8,695,652~~tolerability ~~shares~~ of ~~our~~a ~~common~~fixed ~~stock (net~~dose of ~~accrued~~PRTX-100 ~~interest~~administered ~~thereon),~~over an ~~bore~~extended ~~interest~~period. atThe asecondary ~~rate~~endpoints ofincluded 3%immunogenicity, ~~per~~effects ~~annum~~on ~~and~~measures ~~matured~~of onRA ~~December~~disease 31activity, ~~2013.~~evaluation ~~The original maturity~~of ~~was~~anti-PRTX-100 ~~December~~antibody 31presence, ~~2012~~and ~~but~~feasibility inof ~~December~~joint ~~2012~~evaluations ~~Niobe~~with ~~agreed,~~ultrasound ~~for~~and nobiomarkers ~~consideration,~~as todisease ~~extend~~markers. ~~the~~A ~~maturity~~total of ~~date~~eight topatients ~~December~~completed ~~31,~~all ~~2013~~105 Study visits per protocol.

~~The~~In $2the ~~Million~~PRTX-100-105 ~~Secured~~Study, ~~Convertible~~a ~~Note~~preliminary interim ~~was~~analysis ~~convertible~~indicated atthat ~~any~~for ~~time,~~patients bywho ~~the~~completed ~~holder~~per protocol, ~~subject~~PRTX-100 ~~only~~exhibited toan ~~the~~acceptable ~~requirement~~safety ~~that~~profile weand ~~have~~RA ~~sufficient authorized shares of common~~disease ~~stock~~activity ~~after~~was ~~taking~~improved ~~into~~in ~~account~~a ~~all~~majority ~~outstanding shares~~ of ~~common~~patients ~~stock~~at ~~and~~ the ~~maximum~~end ~~number~~ of ~~shares~~the ~~issuable~~study ~~under~~as ~~all~~compared ~~issued and~~to ~~outstanding convertible securities~~baseline. In ~~addition,~~No ~~the~~serious $2adverse ~~Million~~events ~~Secured~~(SAEs) were ~~Convertible~~reported. ~~Note~~At ~~would~~study ~~automatically~~day ~~be converted~~196, ifone wemonth ~~undertake~~after ~~certain~~the ~~Fundamental~~final ~~Transactions~~dose, aspatients ~~defined~~who incompleted the $2study ~~Million~~per ~~Secured~~protocol ~~Convertible~~demonstrated ~~Note, (such as~~ a ~~merger,~~mean ~~sale~~reduction of ~~all~~the ofDAS28CRP ~~our~~score ~~assets,~~from ~~exchange~~5.25 orto ~~tender offer~~2.52, orsuggesting ~~reclassification~~a ofclinically ~~our~~meaningful ~~stock~~improvement orin ~~compulsory~~disease ~~exchange)~~activity. ~~The~~ $2Additionally, ~~Million~~clinical ~~Secured~~assessment ~~Convertible~~by ~~Note~~Ultrasound ~~also~~Power ~~provided~~Doppler ~~for~~Joint ~~the~~Counts ~~adjustment~~(UPD), ofalso ~~the~~revealed ~~conversion~~a ~~price~~reduction in ~~the~~average ~~event~~disease ofseverity ~~stock~~by ~~dividends and stock~~day ~~splits~~196, and ~~provides for acceleration of maturity, at~~ the ~~holder’s~~correlation ~~option,~~between ~~upon an event of default, as defined in~~ the ~~$2 Million~~UPD ~~Secured Convertible Note. On August 27, 2013, Niobe elected to convert the principal~~ and ~~accrued interest of $2,155,000 under~~ the $2DAS28CRP ~~Million~~was ~~Secured~~r=0.624 ~~Convertible Note into 9,369,565 shares of common stock~~(p<.0005).

OnIn ~~February~~November 12015, ~~2012,~~ we ~~raised~~commenced ~~$1,000,000~~enrollment and ofenrolled ~~working~~our ~~capital~~first ~~pursuant~~patient in the PRTX-100-202 Study. The PRTX-100-202 Study may enroll up to a36 ~~loan~~patients ~~from~~in ~~Niobe~~as many as six cohorts. Each Wepatient ~~issued~~will receive four weekly intravenous doses of PRTX-100 and will be monitored for up to ~~Niobe~~48 aweeks ~~secured~~thereafter. ~~promissory~~The ~~note~~primary study inendpoint of the ~~principal~~PRTX-100-202 ~~amount~~Study ofis $1a platelet response to PRTX-100. Secondary endpoints include safety,~~000~~ immunogenicity,~~000~~ (and pharmacokinetics. One patient in each of the ~~“February~~first ~~2012~~two ~~Secured~~cohorts ~~Note”)~~of the PRTX-100-202 Study has had a platelet response per protocol. Enrollment ~~The~~is ~~February~~continuing ~~2012~~for ~~Secured~~patients ~~Note~~in ~~bore~~the ~~interest~~fourth atcohort ain ~~rate~~the ofPRTX-100-202 3%Study ~~per~~at ~~annum~~an ~~and~~increased ~~had a~~dose ~~maturity~~at ~~date~~study ofsites ~~February~~in 1,both the ~~2014~~U.S. and the UK.

OnIn ~~June~~January 52016, ~~2012,~~ we ~~raised~~commenced anenrollment ~~additional~~of ~~$1,000,000~~our offirst ~~working~~patient ~~capital~~in ~~pursuant~~the European based PRTX-100-203 Study. The PRTX-100-203 Study may enroll up to an30 ~~incremental~~patients ~~loan~~in ~~from~~as ~~Niobe~~many as five cohorts. Each patient will receive four weekly intravenous doses of PRTX-100 and ~~issued~~will be monitored for up to ~~Niobe~~48 aweeks ~~secured~~thereafter. The ~~promissory~~primary ~~note~~study inendpoints of the ~~principal amount~~PRTX-100-203 ofStudy $1include safety,~~000,000,~~ ~~which~~immunogenicity ~~bore~~and ~~interest~~pharmacokinetics. atSecondary aendpoints include ~~rate~~platelet ofresponse 3%and ~~per~~duration. ~~annum~~Two ~~and~~patients in the PRTX-100-203 Study have had a ~~maturity~~platelet ~~date~~response per protocol. Following the recommendation of ~~May~~our ~~31,~~Safety ~~2014~~and (Monitoring Committee upon evaluating safety data from the ~~“June~~fifth ~~2012~~dosage cohort of 24 mg/kg, ~~Secured~~enrollment ~~Note”)~~is continuing in the UK for up to three additional patients in the 18 mg/kg dosage cohort.

OnWe ~~October~~maintain 1,an ~~2012,~~administrative weoffice ~~raised~~in ~~$800,000~~Florham ofPark, ~~additional~~New ~~working~~Jersey ~~capital~~and ~~pursuant~~currently tooutsource anall ~~incremental~~of ~~loan~~our ~~from~~product ~~Niobe~~development and ~~issued~~regulatory toactivities, ~~Niobe~~including aclinical ~~secured~~trial ~~promissory note in the principal~~activities, ~~amount~~manufacturing ~~of $800,000, which bore interest at a rate of 3% per annum~~ and ~~had~~laboratory aoperations, ~~maturity~~to ~~date~~third-party ofcontract ~~October~~research 1organizations, ~~2014~~consultants ~~(the~~and ~~“October 2012 Secured Note”)~~facilities.

OnIn ~~December~~April 32009, ~~2012~~under prior management, we ~~raised $700,000~~ceased ofall ~~additional~~operations ~~working~~and ~~capital~~terminated ~~pursuant~~all toemployees anin ~~incremental~~light ~~loan~~of ~~from~~insufficient ~~Niobe~~funds ~~and issued~~ to ~~Niobe~~continue aour ~~secured~~clinical ~~promissory~~trials ~~note~~and inrelated ~~the principal~~product ~~amount~~development. ofOur ~~$700,000,~~business ~~which~~was ~~bore~~dormant ~~interest~~until atcurrent amanagement ~~rate~~took control of 3%our ~~per~~operations ~~annum~~in ~~and~~November ~~had~~2009 afollowing ~~maturity~~the ~~date~~change in ofcontrol ~~October~~transaction 1,more ~~2014~~fully ~~(the~~described ~~“December 2012 Secured Note”)~~below.

~~Collectively, the February 2012 Secured Note, the June 2012 Secured Note, the October 2012 Secured Note and the December 2012 Secured Note are hereinafter referred to as the “2012 Secured Notes.”~~13

OnChange ~~January 18, 2013, we raised $2,500,000 of additional working capital pursuant to an incremental loan from Niobe and issued to Niobe a secured promissory note~~ in ~~the~~Control ~~principal amount of $2,500,000, which bore interest at a rate of 3% per annum~~ and ~~had a maturity date of January 15, 2015 (the “January~~Incremental ~~2013~~Financing ~~Secured Note”).~~Transactions

On ~~May~~November 1311, ~~2013~~2009 (the “Effective Date”), we consummated a financing transaction (the “Financing”) in which we raised $23,000,000 of ~~additional~~ working capital pursuant to ana ~~incremental~~Securities ~~loan~~Purchase ~~from~~Agreement (the “Purchase Agreement”) with Niobe ~~and~~Ventures, LLC, a Delaware limited liability company (“Niobe”). Pursuant to the Purchase Agreement, we issued to Niobe (i) 8,695,652 restricted shares of our common stock at a purchase price of $0.23 per share (or $2 million in the aggregate) and (ii) a senior secured convertible promissory note in the principal amount of $~~2,000,000,~~1 ~~which~~million ~~bore~~convertible ~~interest~~into atshares ~~a rate~~ of 3%our ~~per~~common ~~annum~~stock ~~and~~at ~~had~~an ainitial ~~maturity~~conversion ~~date~~price equal ofto ~~May~~$0.23 ~~13,~~per ~~2015~~share (the “~~May~~$1 ~~2013~~ Million Secured Note”). On February 11, 2011, Niobe converted the $1 Million Secured Note, including $37,500 of accrued interest thereon, into 4,510,870 shares of common stock.

OnAs ~~August~~contemplated ~~27,~~by ~~2013,~~the wePurchase ~~raised $1~~Agreement,~~000,000~~ all of ~~additional~~our ~~working~~executive ~~capital~~officers ~~pursuant~~and toall anof ~~incremental~~the ~~loan~~members ~~from~~of ~~Niobe~~our ~~and~~Board ~~issued~~of Directors (the “Board”) prior to ~~Niobe~~the aclosing ~~secured~~of the ~~promissory~~Financing, ~~note~~with inthe exception of Frank M. Dougherty, resigned effective concurrently with the ~~principal~~closing of the Financing. Mr. ~~amount~~Dougherty resigned effective upon the expiration of $the 10-day notice period required by Rule 14f-1 under the Securities Exchange Act of 1934,~~000~~ as amended (the “Exchange Act”). In addition,~~000~~ effective upon the closing of the Financing, our ~~which~~Board ~~bears~~appointed ~~interest~~Arnold atP. Kling as a ~~rate~~director ofand 3%then ~~per~~elected ~~annum~~him ~~and~~as ~~matures~~our onpresident ~~August~~and ~~27,~~elected ~~2015~~Kirk ~~(the~~M. ~~“August~~Warshaw ~~2013~~as ~~Secured~~our chief ~~Note”)~~financial officer and secretary.

~~Collectively~~On February 11, 2011, for the ~~January~~purpose ~~2013~~of ~~Secured~~providing us with additional working capital, pursuant to an existing Credit Facility Agreement dated as of December ~~Note~~2, 2009 (the ~~May~~“Facility”) ~~2013~~with Niobe, we issued to Niobe a senior secured convertible promissory note in the principal amount of $2 million (the “$2 Million Secured Convertible Note”). The $2 Million Secured Convertible Note provided for conversion into shares of our common stock at a conversion price of $0.23 per share, for an aggregate of 8,695,652 shares of our common stock (net of accrued interest thereon), bore interest at a rate of 3% per annum and ~~the~~matured ~~August~~on December 31, 2013. The ~~Secured~~original ~~Note~~maturity ~~are~~was ~~hereinafter~~December ~~referred~~31, 2012 but in December 2012 Niobe agreed, for no consideration, to asextend the ~~“2013~~maturity ~~Secured~~date to ~~Notes~~December 31, 2013.”

~~Collectively~~The $2 Million Secured Convertible Note was convertible at any time, by the ~~2012~~holder, ~~Secured~~subject ~~Notes~~only to the requirement that we have sufficient authorized shares of common stock after taking into account all outstanding shares of common stock and the maximum number of shares issuable under all issued and outstanding convertible securities. In addition, the ~~2013~~$2 Million Secured ~~Notes~~Convertible ~~represent~~Note would automatically be converted if we undertake certain Fundamental Transactions, as defined in the $2 Million Secured Convertible Note, (such as a ~~total~~merger, sale of $9all of our assets,~~000~~ exchange or tender offer,~~000~~ or reclassification of our stock or compulsory exchange). The $2 Million Secured Convertible Note also provided for the adjustment of the conversion price in ~~principal~~the ~~amount~~event of ~~loans~~stock ~~from~~dividends ~~Niobe~~and stock splits, and ~~are~~provides ~~hereinafter~~for ~~referred~~acceleration to of maturity, at the holder’s option, upon an event of default, as defined in the “$2 Million Secured ~~Notes~~Convertible Note.” On August 27, 2013, Niobe elected to convert the principal and accrued interest of $2,155,000 under the $2 Million Secured Convertible Note into 9,369,565 shares of common stock.

On ~~October~~February 111, ~~2013~~2012, we ~~issued~~raised ~~a Consolidated, Amended and Restated Promissory Note to Niobe in the principal amount of~~ $91,~~219~~000,~~366~~000 ~~(the “Consolidated Note”). The face amount~~ of ~~the~~working ~~Consolidated~~capital ~~Note~~pursuant ~~reflects~~to ~~the~~a ~~$9.0~~loan ~~million aggregate principal amount of the Secured Notes plus interest accrued at 3% per annum on each note~~ from ~~its respective date of issuance~~Niobe. ~~The~~ ~~terms~~We ofissued ~~the Consolidated Note were identical~~ to ~~the~~Niobe ~~Secured Notes except that: (~~a) ~~the~~secured ~~maturity~~promissory ~~date~~note ~~was September 1, 2015, which is after the latest maturity date of any of the Secured Notes; and (b) it provided for partial mandatory repayment~~ in the ~~event~~principal ~~that the Company received aggregate gross proceeds in excess of $7.5 million from a single or multiple “Liquidity Events” in an~~ amount ~~equal to twenty-five (25%) percent~~ of ~~such gross~~$1,000,000 ~~proceeds~~ (the “~~Mandatory~~February ~~Repayment”). A~~2012 ~~“Liquidity~~Secured ~~Event~~Note” ~~means (a~~) the sale of any of our equity, or equity-linked, securities, and (b) the receipt of proceeds, directly or indirectly related to a development and/or commercialization relationship entered into with an unaffiliated third party. InThe ~~the~~February 2012 Secured ~~Notes,~~Note ~~the~~bore ~~entire~~interest ~~principal amount of each note was due,~~ at ~~Niobe’s~~a ~~election,~~rate ~~upon the consummation~~ of an3% ~~equity~~per ~~financing~~annum ~~of $7.5 million or greater. Consistent with the terms of the Secured Notes~~ and ~~related security agreements entered into, our obligations under the Consolidated Note are secured~~had by a ~~first~~maturity ~~priority~~date ~~perfected security interest in all~~ of ~~our~~February ~~assets pursuant to a Consolidated~~1, ~~Amended and Restated Security Agreement dated October 11, 2013~~2014.

13 On June 5, 2012, we raised an additional $1,000,000 of working capital pursuant to an incremental loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $1,000,000, which bore interest at a rate of 3% per annum and had a maturity date of May 31, 2014 (the “June 2012 Secured Note”).

On ~~January~~October 231, ~~2014~~2012, we ~~consummated~~raised ~~a private placement financing to accredited investors of 471,334 shares of common stock at~~ $~~6.00 per share~~800, ~~yielding gross proceeds of $2,828,~~000~~. No~~ ~~commissions were payable in connection with the financing transaction. Proceeds~~ of ~~the financing have been, and will continue~~additional ~~to be, used for~~ working capital ~~purposes,~~pursuant ~~principally~~ to ~~fund~~an ~~ongoing~~incremental ~~clinical~~loan ~~trials~~from ~~and~~Niobe ~~studies~~ and ~~related~~issued ~~activities. The~~to ~~investors~~Niobe ina ~~the~~secured ~~offering~~promissory ~~were~~note ~~granted~~in ~~piggy-back~~the ~~registration~~principal ~~rights~~amount of in$800,000, ~~connection~~which ~~with~~bore ~~certain~~interest ~~registration~~at ~~statements~~a ~~filed by~~rate ~~us,~~of ~~subject~~3% toper ~~certain~~annum ~~exceptions,~~and ~~including~~had a ~~registration~~maturity ~~statement~~date ~~filed~~of inOctober ~~connection~~1, ~~with~~2014 a(the ~~primary~~“October ~~offering~~2012 Secured Note”).

On ~~November~~December 43, ~~2014~~2012, we ~~entered~~raised ~~into~~$700,000 ~~a new~~of ~~Credit~~additional ~~Facility~~working ~~Agreement~~capital ~~(the “2014 Credit Facility Agreement”)~~ pursuant to ~~which we may borrow up to~~ an ~~additional $5.0~~incremental ~~Million~~loan from Niobe, inand ~~the~~issued ~~form~~to ofNiobe a secured ~~loans,~~promissory note in ~~accordance with~~ the ~~2014 Credit Facility Agreement at any time prior~~principal toamount ~~the~~of ~~December 31~~$700,000, ~~2015~~which ~~expiration~~bore ~~date (the “2014 Credit Facility”). Each loan made under the 2014 Credit Facility Agreement has been represented by a senior secured promissory note bearing~~ interest at a rate of 3% per annum ~~which~~and ~~matures~~had ~~on September 1, 2016 (each an “Original Note”). Our obligations under each Original Note have been secured by~~ a ~~first priority~~maturity ~~perfected~~date ~~security interest in all~~ of ~~our~~October ~~assets pursuant to the Second Consolidated~~1, ~~Amended and Restated Security Agreement between us and Niobe, entered into at the same time as the~~ 2014 ~~Credit Facility Agreement~~ (the “~~Security~~December 2012 ~~Agreement~~Secured Note”).

~~In addition~~Collectively, onthe ~~November~~February 4,2012 ~~2014,~~Secured ~~we entered into a~~ Note ~~Modification Agreement (~~, the ~~“Note~~June ~~Modification~~2012 ~~Agreement”)~~Secured ~~with Niobe pursuant to which the Consolidated~~ Note, asthe ~~modified in~~ October ~~2014,~~2012 ~~was~~Secured ~~further~~Note ~~amended~~and ~~to increase~~ the ~~threshold~~December ~~amount~~2012 ~~requiring~~Secured aNote ~~Mandatory~~are ~~Prepayment~~hereinafter ~~from~~referred ~~$7.5 Million~~ to ~~more~~as ~~than $10 Million. As a result, partial prepayment will now be triggered in~~ the ~~event of a Liquidity Event in which~~ we“2012 ~~receive~~Secured ~~gross proceeds in excess of $10 million~~Notes. ~~All other terms and provisions of the Consolidated Note remained unchanged and in full force and effect.~~”

On December 1, 2015, the 2014 Credit Facility was amended to increase the funds available for loans to us to $7.5 million and to extend the expiration date of such credit facility to December 31, 2016 pursuant to which we entered into and an Amended and Restated 2014 Credit Facility Agreement (the “Amended and Restated Agreement”). Each loan under the Amended and Restated Agreement has been and will be represented by a senior secured promissory note bearing interest at a rate of 3% per annum which matures on September 1, 2017 (each a “New Note”). In addition, the Security Agreement was also amended and restated to secure our obligations under all the Original Notes and all the New Notes.14

On ~~June~~January 3018, ~~2016~~2013, ~~the~~ ~~2014~~we ~~Credit~~raised ~~Facility~~$2,500,000 ~~was~~of additional ~~again~~working ~~amended~~capital pursuant to ~~increase~~an ~~the~~incremental ~~funds~~loan ~~available~~from ~~for~~Niobe ~~loans~~and toissued us to ~~$9.0~~Niobe ~~million~~a ~~(the~~secured ~~“Second~~promissory ~~Amended and~~note ~~Restated~~in ~~Agreement”). Each loan under~~ the ~~Second~~principal amount ~~Amended~~of ~~and~~$2,500,000, ~~Restated~~which ~~Agreement~~bore ~~has~~interest ~~been~~at ~~represented by~~ a ~~New~~rate ~~Note.~~of ~~In addition,~~3% ~~the~~per ~~Security~~annum ~~Agreement was also amended~~ and ~~restated~~had toa ~~secure~~maturity ~~our~~date ~~obligations under all the notes issued under the 2014 Credit Facility as~~ of ~~June~~January 3015, ~~2016~~2015 ~~and all~~ (the ~~New~~“January 2013 ~~Notes~~Secured ~~issued pursuant to the Second Amended and Restated Agreement~~Note”).

On ~~August~~May 3113, ~~2016~~2013, we ~~and~~raised ~~Niobe~~$2,000,000 ~~agreed~~of toadditional working ~~extend~~capital ~~the~~pursuant ~~maturity~~to ~~date~~an ofincremental ~~the~~loan ~~Consolidated~~from ~~Note~~Niobe and ~~the~~issued ~~maturity~~to ~~dates~~Niobe ofa ~~all~~secured ~~thirteen~~promissory ~~outstanding~~note ~~Original Notes~~in ~~with~~the ~~an aggregate~~ principal amount of $52,~~030~~000,000, ~~from~~which ~~September~~bore 1,interest ~~2016~~at toa ~~September~~rate 1,of ~~2017.~~3% ~~All~~per ~~other~~annum ~~terms~~ and ~~provisions of~~had ~~the~~a ~~Consolidated~~maturity ~~Note~~date ~~and~~of ~~Original~~May ~~Notes~~13, ~~remained~~2015 ~~unchanged~~(the ~~and~~“May in2013 ~~full force and effect~~Secured Note”).

On ~~October~~August 3127, ~~2016~~2013, ~~the~~ ~~2014~~we ~~Credit~~raised ~~Facility~~$1,000,000 ~~was~~of additional ~~amended~~working tocapital ~~increase~~pursuant ~~the funds available for loans~~ to usan toincremental ~~$11.25~~loan ~~million~~from Niobe and toissued ~~extend the expiration date of the facility~~ to ~~June~~Niobe ~~15,~~a ~~2017~~secured ~~(the~~promissory ~~“Third~~note ~~Amended~~in ~~and Restated Agreement”). Each loan under~~ the ~~Third Amended~~principal ~~and~~amount ~~Restated~~of ~~Agreement~~$1,000,000, ~~will~~which bebears ~~represented by a senior secured promissory note bearing~~ interest at a rate of 3% per annum ~~which~~ and matures on ~~March~~August 3127, ~~2018~~2015 (~~each~~the a “~~2018~~August 2013 Secured Note”). The Security Agreement was also amended and restated to secure our obligations under all the notes issued under the 2014 Credit Facility as of October 31, 2016 and all the 2018 Notes. In addition, we and Niobe also agreed to extend to March 31, 2018, the maturity dates of the Consolidated Note and all the notes issued and outstanding under the 2014 Credit Facility as of October 31, 2016.

~~As of May 31~~Collectively, ~~2017,~~ the ~~outstanding~~January ~~principal balance~~2013 ~~under~~Secured Note, the ~~2014~~May ~~Credit~~2013 ~~Facility~~Secured ~~totaled $11~~Note,~~080,000.~~ ~~During~~and the ~~year~~August ~~ended~~2013 ~~May~~Secured ~~31,~~Note ~~2017,~~are wehereinafter ~~borrowed~~referred anto ~~aggregate~~as ofthe ~~$3,980,000~~“2013 Secured Notes.”

~~On June 1~~Collectively, ~~2017,~~ the ~~2014~~2012 ~~Credit~~Secured ~~Facility was~~Notes ~~amended~~and ~~to increase~~ the 2013 ~~funds~~Secured ~~available~~Notes ~~for~~represent ~~loans~~a tototal usof to $~~13.05~~9,000,000 ~~million~~in ~~and~~principal toamount ~~extend the expiration date~~ of ~~such~~loans ~~facility to~~from ~~March~~Niobe ~~31, 2018 (the “Fourth Amended~~ and ~~Restated~~are ~~Agreement”).~~hereinafter ~~Each~~referred ~~loan~~to ~~under~~as the ~~Fourth Amended and Restated Agreement~~ ~~will~~“Secured ~~be represented by a 2018 Note. The Security Agreement was also amended and restated to also secure our obligations under all the 2018~~ Notes ~~issued pursuant to the Fourth Amended and Restated Agreement~~.”

14 On October 11, 2013, we issued a Consolidated, Amended and Restated Promissory Note to Niobe in the principal amount of $9,219,366 (the “Consolidated Note”). The face amount of the Consolidated Note reflects the $9.0 million aggregate principal amount of the Secured Notes plus interest accrued at 3% per annum on each note from its respective date of issuance. The terms of the Consolidated Note were identical to the Secured Notes except that: (a) the maturity date was September 1, 2015, which is after the latest maturity date of any of the Secured Notes; and (b) it provided for partial mandatory repayment in the event that the Company received aggregate gross proceeds in excess of $7.5 million from a single or multiple “Liquidity Events” in an amount equal to twenty-five (25%) percent of such gross proceeds (the “Mandatory Repayment”). A “Liquidity Event” means (a) the sale of any of our equity, or equity-linked, securities, and (b) the receipt of proceeds, directly or indirectly related to a development and/or commercialization relationship entered into with an unaffiliated third party. In the Secured Notes, the entire principal amount of each note was due, at Niobe’s election, upon the consummation of an equity financing of $7.5 million or greater. Consistent with the terms of the Secured Notes and related security agreements entered into, our obligations under the Consolidated Note are secured by a first priority perfected security interest in all of our assets pursuant to a Consolidated, Amended and Restated Security Agreement dated October 11, 2013.

On ~~June~~January 1523, ~~2017~~2014, ~~July~~we ~~10,~~consummated ~~2017~~a ~~and August~~private ~~10,~~placement ~~2017~~financing to accredited investors of 471,334 weshares ~~borrowed~~of common stock at $~~290~~6.00 per share,~~000,~~ yielding gross proceeds of $~~290~~2,828,000. No ~~and~~commissions ~~$290~~were payable in connection with the financing transaction. Proceeds of the financing have been,~~000,~~ ~~respectively~~and will continue to be, ~~under~~used ~~the~~for ~~2014~~working ~~Credit~~capital ~~Facility~~purposes, ~~pursuant~~principally to ~~the~~fund ~~Fourth~~ongoing ~~Amended and~~clinical ~~Restated~~trials ~~Agreement~~and studies and ~~issued~~related ~~Niobe~~activities. The ainvestors ~~new~~in ~~2018~~the ~~Note~~offering ~~for~~were ~~each~~granted ~~borrowing~~piggy-back registration rights in ~~the~~connection ~~same~~with ~~principal~~certain ~~amount~~registration ofstatements ~~each~~filed by ~~loan~~us, subject to certain exceptions, including a registration statement filed in connection with a primary offering.

On ~~August~~November 224, ~~2017~~2014, we ~~and~~entered ~~Niobe~~into ~~agreed~~a new Credit toFacility ~~extend~~Agreement (the ~~maturity~~“2014 ~~date~~Credit ofFacility ~~all~~Agreement”) ~~outstanding~~pursuant ~~notes~~to ~~issued~~which we may borrow up to ~~Niobe~~an additional $5.0 Million from ~~the~~Niobe, ~~current~~in ~~maturity~~the ~~date~~form of ~~March~~secured 31loans, ~~2018~~in toaccordance awith ~~new~~the 2014 Credit Facility Agreement at any time prior to the ~~maturity~~December 31, 2015 expiration date (the “2014 Credit Facility”). Each loan made under the 2014 Credit Facility Agreement has been represented by a senior secured promissory note bearing interest at a rate of ~~September~~3% per annum which matures on September 1, ~~2018~~2016 (each an “Original Note”). ~~All~~ ~~other~~Our ~~terms~~obligations ~~and~~under ~~provisions~~each ofOriginal ~~such~~Note ~~notes~~have ~~remained~~been ~~unchanged~~secured ~~and~~by a first priority perfected security interest in ~~full~~all ~~force~~of our assets pursuant to the Second Consolidated, Amended and Restated Security Agreement between us ~~effect~~and Niobe, entered into at the same time as the 2014 Credit Facility Agreement (the “Security Agreement”).

AsIn ofaddition, ~~August~~on ~~31,~~November ~~2017~~4, ~~the~~ ~~outstanding principal balance under the~~ 2014 ~~Credit Facility totaled $11~~,~~950,000.~~ ~~During~~we ~~the~~entered into ~~three~~a ~~months~~Note ~~ended~~Modification ~~August~~Agreement ~~31, 2017,~~ (the ~~Company~~“Note ~~borrowed~~Modification anAgreement”) ~~aggregate~~with ofNiobe ~~$870,000;~~pursuant ~~$290,000~~to onwhich ~~June~~the 15Consolidated Note, ~~2017,~~as ~~$290,000~~modified onin ~~July~~October 102014, ~~2017,~~was ~~and~~further ~~$290,000~~amended onto ~~August 10,~~increase ~~2017. Payment of~~ the ~~principal~~threshold ~~and~~amount ~~accrued~~requiring ~~interest~~a onMandatory ~~all~~Prepayment ~~outstanding~~from ~~notes~~$7.5 Million ~~issued~~to ~~under~~more ~~the~~than ~~2014~~$10 ~~Credit~~Million. ~~Facility~~As ~~will,~~a ~~at Niobe’s election~~result, ~~automatically~~partial ~~become~~prepayment ~~immediately~~will ~~due~~now ~~and~~be ~~payable~~triggered ifin the ~~Company~~event ~~undertakes~~of ~~certain~~a ~~Fundamental~~Liquidity ~~Transactions or upon an~~ Event ofin ~~Default,~~which we ~~both~~receive asgross ~~defined~~proceeds in ~~such~~excess ~~notes~~of $10 million. ~~The~~All ~~Company’s~~other ~~obligations~~terms ~~under~~and ~~all~~provisions ~~such~~of ~~notes~~the ~~are~~Consolidated ~~secured~~Note byremained unchanged ~~the~~and ~~Security~~in ~~Agreement,~~full asforce ~~amended~~and effect.

~~On September~~ 15, 2017, we borrowed an additional $290,000 under the terms of the Fourth Amended and Restated Agreement and issued Niobe a 2018 Note with a maturity date of September 1, 2018 (a “New 2018 Note”) for the loan in the same principal amount.

~~All~~On ofDecember 1, 2015, the ~~securities~~2014 ~~issued~~Credit inFacility was amended to increase the ~~aforementioned financings~~funds ~~were~~available ~~issued~~for inloans ~~reliance~~to ~~upon~~us ~~the~~to ~~exemption~~$7.5 ~~from~~million and to extend the ~~registration~~expiration ~~requirements~~date of ~~the~~such ~~Securities~~credit ~~Act~~facility to ofDecember ~~1933~~31, as2016 ~~amended~~ pursuant to which we entered into and an Amended and Restated 2014 Credit Facility Agreement (the “~~Act~~Amended and Restated Agreement”). ~~pursuant~~Each toloan ~~Section~~under ~~4(a)(5)~~the Amended and ~~Rule~~Restated ~~506~~Agreement ofhas ~~Regulation~~been Dand ~~thereof. The~~will ~~offer,~~be ~~sale~~represented ~~and~~by ~~issuance~~a senior ofsecured ~~such~~promissory ~~securities~~note ~~were~~bearing ~~made~~interest ~~without~~at ~~general~~a ~~solicitation~~rate orof ~~advertising.~~3% ~~The~~per ~~securities~~annum ~~were~~which ~~offered~~matures ~~and~~on ~~issued~~September ~~only~~1, to2017 (each a “~~accredited investors~~New Note”). In asaddition, ~~such~~the ~~term~~Security isAgreement ~~defined~~was inalso ~~Rule~~amended ~~501~~and restated to secure our obligations under all the ~~Act~~Original Notes and all the New Notes.

~~About~~On ~~PRTX-100~~June 30, 2016, the 2014 Credit Facility was again amended to increase the funds available for loans to us to $9.0 million (the “Second Amended and Restated Agreement”). Each loan under the Second Amended and Restated Agreement has been represented by a New Note. In addition, the Security Agreement was also amended and restated to secure our obligations under all the notes issued under the 2014 Credit Facility as of June 30, 2016 and all the New Notes issued pursuant to the Second Amended and Restated Agreement.

~~PRTX-100~~On isAugust a31, ~~proprietary~~2016, ~~highly purified~~we ~~form~~and ofNiobe ~~the~~agreed ~~Staphylococcal~~to ~~bacterial~~extend ~~protein~~the ~~known~~maturity asdate ~~Protein A which is a bacterial protein known to modify aspects~~ of the ~~human immune~~Consolidated ~~system.~~Note ~~PRTX-100~~and ~~has~~ the ~~ability,~~maturity atdates ~~very~~of ~~low~~all ~~concentrations,~~thirteen tooutstanding ~~bind to human B-lymphocytes and macrophages and to modulate~~Original ~~immune~~Notes ~~processes.~~with ~~Pre-clinical~~an ~~studies~~aggregate ~~also~~principal ~~demonstrate~~amount ~~that low doses~~ of ~~PRTX-100~~$5,030,000, ~~have~~from ~~potent~~September ~~therapeutic~~1, ~~effects~~2016 into ~~certain~~September ~~models of~~1, ~~immune-mediated inflammatory diseases~~2017. ~~Both~~All ~~the~~other ~~PRTX-100-103~~terms and provisions of the ~~PRTX-100-104~~Consolidated ~~studies~~Note ~~demonstrated that PRTX-100 was generally safe~~ and ~~well~~Original ~~tolerated~~Notes atremained ~~all~~unchanged ~~dose levels,~~ and ~~at certain higher doses, more patients showed improvement~~ in ~~measures~~full offorce ~~disease activity~~and ~~than did patients at the lower dose or placebo cohorts~~effect.

~~Animal~~On ~~Studies~~October 31, 2016, the 2014 Credit Facility was amended to increase the funds available for loans to us to $11.25 million and to extend the expiration date of the facility to June 15, 2017 (the “Third Amended and Restated Agreement”). Each loan under the Third Amended and Restated Agreement will be represented by a senior secured promissory note bearing interest at a rate of 3% per annum which matures on March 31, 2018 (each a “2018 Note”). The Security Agreement was also amended and restated to secure our obligations under all the notes issued under the 2014 Credit Facility as of October 31, 2016 and all the 2018 Notes. In addition, we and Niobe also agreed to extend to March 31, 2018, the maturity dates of the Consolidated Note and all the notes issued and outstanding under the 2014 Credit Facility as of October 31, 2016.

~~Protalex’s~~As ~~lead~~of ~~product~~May ~~candidate~~31, ~~PRTX-100~~ 2017, the ~~has~~outstanding ~~demonstrated~~principal ~~positive~~balance ~~results~~under inthe ~~several~~Senior ~~standard~~Secured ~~mouse~~Debt ~~models~~to ofNiobe ~~autoimmunity~~totaled $20,299,366, including $9,219,366 under the ~~following:~~Consolidated Note and $11,080,000 under the 2014 Credit Facility.

~~Collagen-Induced~~On ~~Arthritis~~June ~~- PRTX-100~~1, ~~has~~2017, ~~demonstrated~~the ~~reproducible~~2014 ~~efficacy~~Credit inFacility ~~this~~was ~~well-established~~amended ~~animal model of RA. Mice received two injections of collagen in order~~ to ~~stimulate an inflammatory response. One group was treated with various doses of PRTX-100, a second group received Enbrel®,~~increase athe ~~leading~~funds ~~commercially~~ available ~~treatment~~ for ~~RA,~~loans ~~and~~to ~~the~~us ~~control~~to ~~group was injected with vehicle saline solution~~$13.05 ~~The~~million ~~mice were observed for clinical symptoms, joint size~~ and ~~loss~~to ofextend ~~function.~~the ~~The~~expiration ~~results~~date ~~showed that low doses~~ of ~~PRTX-100~~such ~~and~~facility ~~standard doses of Enbrel® suppressed clinical symptoms including joint swelling over the first two~~ to ~~three~~March ~~weeks of treatment~~31, ~~and~~2018 ~~slowed~~(the ~~disease~~“Fourth ~~progression~~Amended asand ~~compared~~Restated ~~with~~Agreement”). ~~the~~Each ~~control~~loan ~~group.~~under ~~Thereafter,~~ the ~~PRTX-100-treated~~Fourth ~~mice~~Amended ~~continued~~and toRestated ~~remain~~Agreement ~~disease-free~~is represented ~~whereas~~by ~~the mice treated with Enbrel® showed~~ a ~~resumption~~2018 ~~of joint inflammation and tissue damage~~Note. ~~This~~The ~~response~~Security toAgreement ~~Enbrel®~~ was ~~expected~~also ~~because~~amended ~~the~~and ~~mice~~restated ~~developed immune response~~ to italso ~~because~~secure itour isobligations aunder ~~foreign~~all ~~protein.~~the ~~Overall,~~2018 ~~these~~Notes ~~results indicate~~issued ~~that~~pursuant ~~PRTX-100~~to isthe aFourth ~~potential~~Amended ~~treatment~~and ~~for~~Restated ~~RA in humans~~Agreement. ~~The data from these studies has served as a rationale for conducting clinical trials in human patients.~~

~~BXSB~~On ~~Mice~~August -22, ~~These~~2017, ~~animals~~we and ~~are~~Niobe ~~genetically~~agreed ~~predisposed~~ to ~~autoimmune~~extend ~~diseases.~~the ~~This~~maturity ~~model~~date isof ~~used~~all tooutstanding ~~evaluate~~notes ~~drugs~~issued ~~for~~to ~~autoimmune~~Niobe ~~diseases~~from ~~such as Lupus and other autoimmune diseases. This genetic model more closely approximates~~ the ~~human~~current ~~condition~~maturity indate ~~that~~of itMarch ~~is complex~~31, ~~multi-factorial~~ ~~and~~2018 ~~usually~~to ~~treated~~a bynew ~~multiple~~maturity ~~drug~~date ~~regimens.~~of InSeptember ~~these studies~~1, ~~mice~~2018. All ~~were~~other ~~treated~~terms ~~with PRTX-100~~ and ~~sacrificed~~provisions atof ~~regular~~such ~~intervals. Their~~notes ~~organs~~remained ~~were~~unchanged ~~weighed~~ and ~~sectioned for histological analysis and their spleens were used for immunological assays. Spleen enlargement, or splenomegaly, was significantly reduced~~ in ~~treated animals compared with the controls at almost every time point,~~ ~~demonstrating~~full ~~the~~force ~~ability of PRTX-100 to delay the onset~~ and ~~severity of this disease~~effect.

During the nine months ended February 28, 2018, we borrowed an aggregate of $1,970,000; $290,000 on June 15 , 2017, $290,000 on July 10, 2017, $290,000 on August 10, 2017, $290,000 on September 15, 2017, $290,000 on October 23, 2017, $200,000 on November 17, 2017, $220,000 on December 15, 2017 and $100,000 on January 12, 2018. Prior to the Offering (described below), the outstanding principal balance under the 2014 Credit Facility totaled $13,050,000.

~~Completed~~On ~~pre-clinical~~February ~~safety~~28, ~~studies in~~2018, ~~animals~~we ~~showed~~raised noan ~~drug-related~~aggregate ~~toxicity~~of at$1.425 ~~doses~~million upfrom toeight ~~5-fold~~accredited ~~the~~investors ~~highest~~in ~~currently~~a ~~planned~~private ~~clinical~~placement ~~trial~~financing (the ~~dose.~~“Offering”) ~~These~~of ~~studies were~~10% ~~conducted~~Senior onConvertible ~~New~~Notes, ~~Zealand~~due ~~white~~on ~~rabbits~~February ~~and~~28, on2023 ~~cynomolgus~~(the ~~monkeys~~“Senior Notes”). No commissions ~~differences~~ were ~~observed~~payable in ~~body~~connection ~~weight~~with ~~gain~~the orOffering ~~food consumption,~~which ~~nor~~was inprincipally ~~hematology,~~sold ~~clinical~~to ~~chemistry,~~our ~~urinalysis,~~existing orstockholders. ~~organ~~Proceeds ~~weight~~of the ~~data~~Offering inwill ~~animals~~be ~~treated~~used ~~with~~for ~~PRTX-100~~working ~~compared with~~capital ~~controls~~purposes, ~~treated~~principally ~~with~~to ~~vehicle.~~fund ~~These~~ongoing ~~study~~clinical ~~results~~trials ~~represent~~and astudies ~~necessary~~and ~~component~~related activities. ofNo ~~our~~registration ~~IND~~rights ~~application~~were ~~with~~granted to the ~~FDA~~investors in the Offering.

~~Additional studies in monkeys have further characterized the PK, toxicity, and pharmacodynamics of PRTX-100 with up to 12 weekly doses.~~16

~~Clinical~~The ~~Trials~~Senior Notes are convertible into shares of common of stock at a price of $0.20 per share at the option of the holder prior to maturity or earlier prepayment, accrue interest at the rate of 10% per annum and are due on February 28, 2023. Upon conversion, the note holder will receive 5,000 shares of our common stock for each $1,000 of principal or accrued interest converted. Two-thirds of the shares issuable upon any conversion of the Senior Notes will be acquired by us from Niobe for nominal consideration ($.01 per share) pursuant to a mandatory call agreement entered into in connection with the Offering (the “Call Agreement”). As a result, for each $1,000 of principal or interest converted, we will issue approximately 1,667 new shares. Accordingly, our effective conversion price will be approximately $0.60 per share of common stock, with Niobe incurring substantially all of the associated dilution. The closing price of per share of common stock on the date of the Offering was $0.45.

~~Favorable~~We ~~pre-clinical safety and efficacy~~evaluated ~~studies~~the ~~for~~conversion ~~our~~feature ~~lead~~of ~~compound, PRTX-100, laid~~ the ~~foundation~~Senior ~~for~~Notes ~~the~~and ~~IND~~determined ~~for~~that ~~treating~~under ~~RA. We submitted~~ the ~~IND~~accounting toguidance ~~the~~for ~~FDA~~“Accounting infor ~~March~~Convertible ~~2005~~Securities ~~and~~with ~~later~~Beneficial inConversion ~~March~~Features” ~~2005 the FDA verbally disclosed to us~~ that ita ~~had~~value ~~placed~~should ~~our~~be ~~IND~~attributed onto ~~clinical~~the ~~hold,~~embedded ~~pending~~conversion ~~additional~~feature. ~~product~~On ~~characterization.~~February In28, ~~August 2005~~2018, ~~we formally replied to~~ the ~~FDA~~date ~~and~~of inissuance ~~September~~of ~~2005,~~ the ~~FDA~~Senior ~~notified~~Notes, ~~us that it had lifted~~ the ~~clinical~~fair ~~hold~~market onvalue ~~our~~of ~~IND~~Common ~~and~~Stock ~~that~~was ~~our~~$0.45 ~~proposed~~per ~~study could proceed~~share. We ~~have completed five clinical trials under this IND.~~determined ~~Our~~the ~~first~~allocation ~~Phase~~to Ithe ~~single-dose~~conversion ~~clinical~~feature ~~trial~~to ~~commenced~~be ~~in December 2005 and was completed in March 2006~~$1.425 ~~This~~million, ~~trial~~which ~~was~~reduced ~~performed in healthy volunteers and was designed primarily to assess~~ the ~~safety~~face ~~and~~amount ~~tolerability~~ of athe ~~single~~Senior ~~intravenous~~Notes ~~dose~~carried ofon ~~PRTX-100.~~our ~~This~~balance ~~study~~sheet ~~demonstrated~~to ~~that PRTX~~-~~100 appears safe and well~~$0-~~tolerated~~. atThis ~~the~~discount ~~doses~~will ~~administered.~~be ~~There~~amortized ~~were~~over no60 ~~deaths~~months orand ~~serious adverse~~will ~~events.~~serve ~~The~~to PKincrease ~~profile~~the ~~was~~interest ~~determined~~expense ~~and~~of ~~found~~the ~~consistent~~Senior Notes ~~with~~during ~~that~~the ~~projected~~term ~~from~~of ~~pre-clinical~~such ~~models~~notes.

In ~~May 2007~~addition, weas a ~~filed~~condition ~~an amendment~~ to the ~~IND~~ ~~with~~consummation of the ~~FDA.~~Offering, ~~This~~on ~~amendment~~February ~~included~~28, ~~the~~2018 ~~final~~we ~~Phase~~entered Iinto ~~safety~~an ~~study~~Exchange ~~report~~Agreement ~~from~~with Niobe (the ~~2006~~“Exchange ~~trial,~~Agreement”) ~~changes~~pursuant to ~~our~~which ~~techniques for~~Niobe ~~purification~~converted ~~and~~$22,269,366 ~~characterization~~ of ~~PRTX-100,~~outstanding anotes ~~Chemistry,~~due ~~Manufacturing~~September ~~and Controls update~~30, 2018 ~~and~~(the aaggregate ~~protocol~~outstanding ~~for~~principal abalance ~~second single-dose~~under ~~Phase~~the IConsolidated ~~clinical~~Note ~~trial. In July~~ and ~~August~~the ~~2007~~2014 aCredit ~~second~~Facility ~~Phase~~as Iof ~~study~~February ~~was performed under the IND~~28, ~~to further characterize~~ ~~the~~2018) ~~safety,~~into PK18,557,805 ~~and~~shares ~~pharmacodynamic profile~~ of acommon ~~single-dose~~stock ~~of PRTX-100 in healthy volunteers~~ at ~~doses~~a inconversion ~~the~~price ~~projected~~of ~~therapeutic range~~$1.20 ~~Final~~per ~~results indicated that the drug appears safe and well-tolerated~~share. ~~In August 2009~~Consequently, aother ~~Phase~~than 1bthe ~~randomized, double-blind,~~Senior ~~placebo-controlled,~~Notes ~~multiple~~issued ~~dose, dose-escalation and tolerability study of PRTX-100~~ in ~~combination~~the ~~with methotrexate or leflunomide in patients with active RA~~Offering, (the ~~“PRTX~~only ~~100-103~~remaining ~~Study”)~~indebtedness ~~was~~on ~~approved~~our bybalance ~~the~~sheet ~~South~~at ~~African~~February ~~Medicines~~28, ~~Control~~2018 ~~Agency.~~is ~~The~~approximately ~~PRTX-100-103~~$1,974,000, ~~Study~~representing ~~commenced~~the inaccrued ~~August~~but ~~2010~~unpaid atinterest ~~three~~on ~~sites~~the innotes ~~South~~converted ~~Africa~~by ~~and was completed in January 2012 as detailed below~~Niobe.

InAll ~~November~~of ~~2012,~~the wesecurities ~~commenced~~issued ~~enrollment and~~in ~~dosing~~the ofaforementioned financings ~~patients~~were atissued ain ~~total~~reliance ofupon ~~nine~~the ~~sites~~exemption infrom the ~~United~~registration ~~States~~requirements ~~for~~of the ~~PRTX-100-104~~Securities ~~Study,~~Act aof ~~second~~1933, ~~multicenter~~as ~~Phase 1b~~amended ~~randomized,~~(the ~~multiple-dose,~~“Act”) ~~dose-escalation~~pursuant ~~study~~to ofSections ~~PRTX-100~~4(a)(2) ~~in combination with methotrexate~~ and/or ~~leflunomide~~4(a)(5) inand ~~adults~~Rule ~~with~~506 ~~active RA~~of ~~which~~Regulation isD ~~still in progress as detailed below~~thereof. The ~~PRTX-100-104~~offer, sale ~~Study~~and ~~sequentially~~issuance ~~escalated the weekly dose~~ of ~~PRTX-100~~such ~~from 1.5~~securities ~~micrograms/kg,~~were ~~the~~made ~~highest~~without ~~dose~~general insolicitation ~~the~~or ~~prior~~advertising. RAThe ~~patient~~securities ~~study,~~were tooffered ~~doses of 3.0, 6.0,~~ and ~~12.0~~issued only ~~micrograms/kg.~~to of“accredited ~~PRTX-100.~~investors” ~~In July~~as ~~2014,~~such ~~the~~term ~~last~~is ~~patient~~defined in ~~the~~Rule ~~PRTX-100-104~~501 ~~Study~~under ~~received their last dose in~~ the ~~fifth and final cohort~~Act.

InAbout ~~February 2015, we commenced enrollment, at a single U.S. site, of a Phase I/II open-label, multiple, fixed-dose study (the “~~PRTX-100-105 Study”) which was open only to PRTX-100-104 Study patients who indicated their desire for additional treatment. The PRTX-100-105 Study was an open-label, single group study with former participants from the 104 Study who were eligible to receive a fixed dose of PRTX-100 over a 6-month period. The primary study endpoint of the 105 Study was the safety and tolerability of a fixed dose of PRTX-100 administered over an extended period. The secondary endpoints included immunogenicity, effects on measures of RA disease activity, evaluation of anti-PRTX-100 antibody presence, and feasibility of joint evaluations with ultrasound and biomarkers as disease markers. A total of eight patients completed all 105 Study visits per protocol.

~~Immune Thrombocytopenia (ITP)~~ PRTX-100 ~~ITP~~ is ana ~~uncommon~~proprietary, ~~autoimmune~~highly ~~bleeding disorder characterized by insufficient platelets in the blood. The affected individuals~~purified ~~make~~form ~~antibodies~~of ~~against their own platelets leading to~~ the ~~platelets'~~Staphylococcal ~~destruction,~~bacterial ~~which~~protein inknown ~~turn~~as ~~leads~~Protein ~~to the abnormal bleeding.~~ A ~~small~~which ~~clinical~~is ~~trial~~a inbacterial ~~adult~~protein ~~patients~~known ~~with chronic ITP was designed~~ to ~~provide~~modify ~~safety~~aspects ~~data~~of onthe ~~repeated~~human immune ~~weekly~~system. ~~dosing with~~ PRTX-100 ~~(the~~ ~~“PRTX-100b-103~~has ~~Study”). This clinical study was to be conducted under~~ the ~~Australian~~ability, ~~and~~at ~~New~~very ~~Zealand~~low ~~Clinical Trial Notification procedure~~concentrations, ~~not~~to ~~under~~bind ato ~~U.S.~~human ~~IND,~~B-lymphocytes and ~~was~~macrophages ~~initiated,~~and ~~but~~to ~~not~~modulate immune ~~completed~~processes. ~~A leading Australian~~ Pre-clinical ~~research organization~~studies ~~was~~also ~~contracted~~demonstrate tothat ~~manage~~low ~~and~~doses ~~monitor this clinical trial. After the approval~~ of ~~the~~PRTX-100 ~~clinical~~have ~~protocol~~potent bytherapeutic ~~ethics~~effects ~~committees at six sites~~ in ~~Australia~~certain ~~and~~models of ~~one~~immune-mediated ininflammatory ~~New~~diseases. ~~Zealand,~~Both the PRTX-~~100b~~100-103 ~~Study~~and ~~began enrolling patients in~~ the ~~second~~PRTX-100-104 ~~quarter~~studies ofdemonstrated ~~2008. The~~that PRTX-~~100b-103~~100 ~~Study~~ was ~~designed~~generally safe toand ~~evaluate~~well ~~the~~tolerated ~~safety~~at ~~and~~all PKdose oflevels, upand toat ~~four~~certain ~~doses~~higher ~~of PRTX-100~~doses, ~~starting~~more atpatients ~~the~~showed ~~lowest~~improvement ~~dose, and~~in ~~escalating~~measures ~~upwards~~of ~~after~~disease activity ~~safety~~than ~~review~~did ofpatients at the ~~prior~~lower dose or placebo cohorts.

~~The~~Animal PRTX-100b-103 Study proved difficult to enroll due to other on-going ITP Phase III studies and subsequent availability of two new and effective medicines for ITP. Nine patients were dosed at the first two dose levels by the end of the first quarter of 2009. At this point further recruitment of patients was suspended. No side effects or toxicities were noted with repeated weekly doses of PRTX-100 at doses of 0.075 and 0.15 micrograms per kg that were not seen with single doses in healthy volunteer trials. This repeated-dose safety data from the PRTX-100b-103 Study was included in the clinical trial application to evaluate PRTX-100 in patients with RA.Studies

16 Protalex’s lead product candidate, PRTX-100, has demonstrated positive results in several standard mouse models of autoimmunity, including the following:

InCollagen-Induced ~~March~~Arthritis ~~2015,~~- PRTX-100 ~~the~~has ~~FDA~~demonstrated ~~accepted~~reproducible ~~our~~efficacy ~~IND application~~in ~~for~~this awell-established ~~Phase~~animal ~~I/II~~model ~~open-label,~~of ~~dose-escalating~~RA. ~~study~~Mice ofreceived ~~PRTX-100~~two injections of collagen in ~~adults~~order ~~with~~to ~~persistent/chronic~~stimulate ~~ITP~~an ~~(the~~inflammatory ~~“PRTX-100-202 Study”)~~response. InOne ~~June~~group ~~2015,~~was ~~the~~treated ~~FDA~~with ~~granted~~various ~~ODD~~doses toof PRTX-100, ~~for~~a ~~the~~second ~~treatment~~group ofreceived ~~ITP.~~Enbrel®, a Inleading ~~July~~commercially ~~2015~~available treatment for RA, and the ~~EMA~~control ~~granted~~group ~~approval~~was ~~for~~injected with vehicle saline solution. The mice were aobserved ~~Phase~~for 1bclinical ~~open-label~~symptoms, ~~dose-escalating~~joint ~~study~~size and loss of ~~PRTX-100~~function. inThe ~~adult~~results ~~patients~~showed ~~with~~that ~~persistent/chronic~~low ~~ITP~~doses ~~(the~~of “PRTX-100~~-203 Study”).~~ Inand ~~September~~standard ~~2015,~~doses of ~~COMP~~Enbrel® ~~issued~~suppressed aclinical ~~positive~~symptoms ~~opinion~~including ~~recommending~~joint ~~PRTX-100~~swelling ~~for~~over ~~designation~~the asfirst antwo ~~orphan~~to ~~medicinal~~three ~~product for~~weeks ~~the~~of treatment, ofand ~~ITP.~~slowed disease Inprogression ~~November~~as ~~2015,~~compared wewith ~~enrolled~~the ~~our~~control ~~first~~group. ~~patient~~Thereafter, in the PRTX-100-~~202~~treated ~~Study~~mice incontinued ~~the~~to ~~United~~remain ~~States~~disease-free whereas ~~and~~the ~~in January~~mice ~~2016~~treated ~~enrolled~~with ~~our~~Enbrel® ~~first~~showed ~~patient~~a inresumption ~~the~~of ~~PRTX~~joint ~~100-203~~inflammation ~~Study~~and intissue ~~Europe~~damage. ~~Enrollment~~This isresponse ~~continuing~~to inEnbrel® was ~~both~~expected ~~studies~~because in the ~~third cohorts~~mice atdeveloped animmune ~~increased~~response ~~dose.~~to Init ~~August~~because ~~2017~~it is a foreign protein. Overall, ~~OOPD~~these ~~awarded~~results usindicate that PRTX-100 is a ~~grant~~potential oftreatment ~~$403,000~~for toRA ~~support~~in ~~the~~humans. ~~future~~The ~~clinical~~data ~~development~~from ~~of PRTX-100~~these studies has served as a ~~treatment~~rationale for ~~ITP~~conducting clinical trials in human patients.

Rheumatoid arthritis - RA is a highly inflammatory polyarthritis often leading to joint destruction, deformity and loss of function. In addition to characteristic symmetric swelling of peripheral joints, systemic symptoms related to chronic inflammation can commonly occur. Chronic pain, disability and excess mortality are unfortunate sequelae. RA is the most common autoimmune disease, affecting 1% to 2% of the world’s population, with prevalence rising with age to about 5% in women over 55.17

~~PRTX-100~~BXSB ~~shows~~Mice ~~measurable~~- ~~activity~~These inanimals aare genetically ~~standard~~predisposed ~~mouse~~to ~~model of~~ autoimmune ~~arthritis~~diseases. AThis ~~substantial~~model ~~body~~is ofused ~~published~~to ~~literature~~evaluate ~~and~~drugs ~~proprietary~~for ~~data~~autoimmune ~~delineate~~diseases ~~the~~such ~~immunomodulatory~~as ~~activities~~Lupus and ofother ~~PRTX-100,~~autoimmune ~~which~~diseases. ~~are~~This ~~distinct~~genetic ~~from~~model ~~those~~more ofclosely ~~current~~approximates ~~major~~the ~~biologic~~human ~~treatments~~condition ~~for~~in ~~rheumatoid~~that ~~arthritis.~~it ~~Accordingly~~is complex, ~~we believe~~multi-factorial ~~that~~and RAusually ~~represents~~treated aby ~~potentially~~multiple ~~important~~drug ~~clinical~~regimens. ~~indication~~In ~~for~~these ~~treatment~~studies, mice were treated with PRTX-100 and sacrificed at regular intervals. Their ~~While~~organs ~~recent~~were ~~advances~~weighed inand ~~biologic~~sectioned ~~treatments~~ for RAhistological ~~have~~analysis ~~improved~~and ~~the~~their ~~prognosis~~spleens were used for ~~many~~immunological ~~patients~~assays. Spleen enlargement, ~~many~~or ~~others~~splenomegaly, ~~continue~~was tosignificantly ~~live~~reduced in treated animals compared with ~~debilitating~~the RAcontrols ~~disease~~at ~~activity~~almost ~~due~~every ~~either~~time point, todemonstrating the ~~cost,~~ability ~~side~~of PRTX-~~effects,~~100 orto ~~limited~~delay ~~effectiveness~~the ofonset ~~these~~and ~~newer~~severity ~~therapies~~of this disease.

~~The~~Completed pre-clinical safety studies in animals showed no drug-related toxicity at doses up to 5-fold the highest currently planned clinical trial dose. These studies were conducted on New Zealand white rabbits and on cynomolgus monkeys. No differences were observed in body weight gain or food consumption, nor in hematology, clinical chemistry, urinalysis, or organ weight data in animals treated with PRTX-100~~-103~~ ~~Study~~compared with controls treated with vehicle. These study results represent a necessary component of our IND application with the FDA.

InAdditional ~~August~~studies ~~2010, we commenced a multi-center Phase 1b clinical trial of PRTX-100~~ in ~~South~~monkeys ~~Africa~~have ~~on adult patients with active RA on methotrexate or leflunomide. The PRTX-100-103~~further ~~Study~~characterized ~~served~~the toPK, ~~evaluate~~toxicity, ~~safety~~ and ~~potential~~pharmacodynamics ~~efficacy~~ of PRTX-100 ~~in patients~~ with ~~active RA and was approved to enroll~~ up to 40 ~~patients~~12 in four dose-escalating cohorts. In January 2012, we completed patient dosing in the fourth cohort of the PRTX-100-103 Study. A total of 37 patients were enrolled in four cohorts ranging from 0.15 micrograms/kg to 1.50 micrograms/kg of PRTX-100 or placebo, administered weekly for four weeks. Measures of safety, PK, and disease activity were evaluated over 16 weeks following the first dose. The PRTX-100-103 Study results demonstrated that PRTX-100 was generally safe and well-tolerated in patients with active RA at all tested dose levels and at the higher doses~~, decreased RA activity as scored by the CDAI~~.

~~The~~Clinical number of patients with a DAS28-CRP < 3.2 (Disease Activity Score) at six weeks was the predefined disease activity endpoint of the study. The results showed that the patients receiving PRTX-100 were more likely to respond than those receiving placebo at all times, the number of responders increased over time during the 16 week study evaluation period, and that the maximum tolerated dose was not reached at the highest dose level.Trials

~~Additionally,~~Favorable ~~the~~pre-clinical ~~results~~safety ~~indicate~~and ~~that~~efficacy ~~PRTX-100~~studies ~~did~~for ~~not~~our ~~change~~lead ~~CRP~~compound, (CPRTX-~~Reactive Protein) levels~~100, ~~even~~laid inthe ~~those~~foundation ~~patients~~for ~~whose~~the ~~swollen~~IND ~~and~~for ~~tender~~treating ~~joint count and global VAS (Visual Analogue Scale) scores had decreased to low levels after treatment~~RA. ~~Because~~We ofsubmitted the ~~influence~~IND ofto the ~~CRP~~FDA ~~component~~in onMarch ~~the~~2005 ~~DAS28-CRP~~and ~~score,~~later ain ~~post-hoc~~March ~~analysis~~2005 ~~was performed examining changes in~~ the ~~CDAI~~FDA ~~scores~~verbally indisclosed ~~all~~to ~~patients.~~us ~~The~~that ~~CDAI~~it ~~score~~had ~~does not~~placed ~~evaluate~~our ~~CRP~~IND ason aclinical ~~component~~hold, ~~but~~pending ~~instead~~additional ~~comprises~~product characterization. ~~physician~~In ~~and~~August ~~patient-assessed~~2005, ~~chemical~~we ~~markers~~formally ofreplied ~~disease~~to ~~activity. In~~ the ~~placebo,~~FDA ~~0.15 micrograms/kg,~~ and ~~0.45~~in ~~micrograms/kg~~September ~~dose groups~~2005, ~~one~~the ~~out~~FDA ofnotified ~~eight~~us ~~patients~~that init ~~each~~had ~~group attained low disease~~lifted ~~activity~~the ~~(CDAI~~clinical ≤hold ~~10)~~ on ~~two~~our orIND ~~more~~and ~~consecutive~~that ~~visits.~~our Inproposed ~~the~~study 0could proceed.90 ~~micrograms/kg~~We ~~and~~have ~~1.50~~completed ~~micrograms/kg~~five ~~dose~~clinical ~~groups,~~trials ~~two~~under ofthis IND. ~~eight~~Our ~~and~~first ~~two~~Phase ofI ~~five~~single-dose ~~patients,~~clinical ~~respectively,~~trial ~~attained~~commenced ~~this~~in ~~same~~December ~~endpoint,~~2005 and ~~maintained~~was acompleted ~~CDAI~~in <March 102006. ~~until~~This ~~the~~trial ~~week~~was ~~16 final~~performed ~~visit.~~in Ofhealthy ~~the~~volunteers ~~four~~and ~~apparent~~was ~~responders~~designed inprimarily ~~the~~to ~~1.50~~assess ~~micrograms/kg~~the ~~group,~~safety ~~two~~and ~~attained~~tolerability of a ~~CDAI~~single ≤intravenous 6dose ~~(remission),~~of ~~one~~PRTX-100. This ~~attained~~study ~~a CDAI~~demonstrated ≤that 10PRTX-100 ~~(low~~appears ~~activity),~~safe and ~~one~~well-tolerated ~~achieved~~at athe ~~CDAI~~doses ~~of 10~~administered.1 atThere ~~one~~were no deaths or ~~more~~serious adverse ~~visits~~events. The ~~mean~~PK ~~time~~profile towas ~~peak~~determined ~~response~~and infound ~~this~~consistent ~~group occurred~~with ~~six~~that ~~weeks~~projected ~~after~~from ~~their~~pre-clinical ~~last dose~~models.

~~The~~In ~~disease~~May ~~activity~~2007, ~~results~~we filed an amendment to the IND with the FDA. This amendment included the final Phase I safety study report from the 2006 trial, changes to our techniques for purification and characterization of PRTX-100, a Chemistry, Manufacturing and Controls update, and a protocol for a second single-~~103~~dose ~~Study~~Phase ~~demonstrated~~I anclinical ~~acceptable~~trial. In July and August 2007 a second Phase I study was performed under the IND, to further characterize the safety, ~~profile~~PK, and ~~suggested~~pharmacodynamic ~~treatment~~profile ~~with~~of a single-dose of PRTX-100 ~~could~~in ~~affect~~healthy ~~disease~~volunteers ~~activity,~~at ~~although~~doses in the projected therapeutic ~~these~~range. ~~effects~~Final ~~were~~results ~~not~~indicated ~~statistically~~that ~~significant~~the drug appears safe and well-tolerated. In ~~November~~August ~~2012~~2009, wea ~~commenced~~Phase ~~the~~1b randomized, double-blind, placebo-controlled, multiple dose, dose-escalation and tolerability study of PRTX-100 in combination with methotrexate or leflunomide in patients with active RA, (the “PRTX 100-~~104~~103 Study”) towas ~~provide~~approved aby ~~better~~the ~~understanding~~South African Medicines Control Agency. ofThe ~~safety~~PRTX-100-103 ~~and~~Study ~~potential~~commenced ~~treatment~~in ~~effect~~August on2010 RAat ~~disease~~three ~~activity~~sites ~~measurements~~in asSouth ~~well~~Africa asand towas ~~help~~completed ~~define~~in ~~the~~January ~~optimal~~2012 ~~dose~~as detailed below.

17 In November 2012, we commenced enrollment and dosing of patients at a total of nine sites in the United States for the PRTX-100-104 Study, a second multicenter Phase 1b randomized, multiple-dose, dose-escalation study of PRTX-100 in combination with methotrexate or leflunomide in adults with active RA which is still in progress as detailed below. The PRTX-100-104 Study sequentially escalated the weekly dose of PRTX-100 from 1.5 micrograms/kg, the highest dose in the prior RA patient study, to doses of 3.0, 6.0, and 12.0 micrograms/kg. of PRTX-100. In July 2014, the last patient in the PRTX-100-104 Study received their last dose in the fifth and final cohort.

In November 2012, we commenced enrollment in the United States for a new multicenter Phase 1b randomized, multiple-dose, dose-escalation study (the “PRTX-100-104 Study”) of PRTX-100 in combination with methotrexate or leflunomide in adult patients with active RA. The sequential dose-escalation phase of this study was expected to enroll up to 40 patients into five cohorts ranging from 1.50 micrograms/kg up to 18.0 micrograms/kg of PRTX-100 or placebo. At each dose, one quarter of patients would receive a placebo treatment. Similar to the PRTX-100-103 Study, the primary objective of the PRTX-100-104 Study was to assess the safety and tolerability of intravenous PRTX-100 administered weekly over five weeks in patients with active RA on methotrexate or leflunomide therapy. The secondary objectives included determining the effects of PRTX-100 on measures of disease activity, assessing the immunogenicity and evaluating the PK parameters after repeated doses, and determining possible relationships between the immunogenicity of PRTX-100 and safety and PK.

InImmune ~~August~~Thrombocytopenia ~~2013,~~(ITP) - ~~following~~ITP ais ~~planned~~an ~~interim safety~~uncommon ~~review~~autoimmune bleeding disorder characterized by ~~our~~insufficient ~~Independent~~platelets ~~Data~~in ~~Safety~~the ~~Monitoring~~blood. ~~Committee~~The ~~and~~affected ~~upon~~individuals make ~~completion~~antibodies ofagainst their own platelets leading to the ~~fourth~~platelets' ~~cohort~~destruction, wewhich ~~expanded~~in turn leads to the 3abnormal bleeding.0 ~~microgram,~~A ~~6.0~~small ~~microgram,~~clinical ~~and~~trial ~~12.0~~in ~~micrograms/kg~~adult ~~dose~~patients ~~cohorts~~with ofchronic ~~the~~ITP was designed to provide safety data on repeated weekly dosing with PRTX-100 (the “PRTX-~~104~~100b-103 Study”). AnThis ~~additional~~clinical ~~nine~~study ~~patients~~was ~~were~~to ~~enrolled in~~be conducted under the ~~expansion~~Australian ~~cohort~~and ~~that~~New Zealand Clinical Trial Notification procedure, not under a U.S. IND, and was initiated, but not completed. inA ~~October~~leading ~~2013~~Australian clinical research organization was contracted to manage and monitor this clinical trial. InAfter ~~total,~~the approval of the ~~first~~clinical ~~four~~protocol ~~dose-escalating~~by ~~cohorts~~ethics ofcommittees at six sites in Australia and one in New Zealand, the PRTX-~~100~~100b-~~104~~ 103 Study, ~~which~~began ~~included~~enrolling ~~these~~patients ~~three~~in ~~expanded~~the ~~cohorts,~~second ~~enrolled~~quarter 41of ~~patients~~2008. The atPRTX-100b-103 ~~five~~Study ~~U.S.~~was ~~clinical~~designed ~~centers~~to ~~with~~evaluate ~~doses~~the ~~ranging~~safety ~~from 1.5~~and ~~micrograms/kg~~PK of up to ~~12.0~~four ~~micrograms/kg.~~doses ~~Five~~of ~~patients~~PRTX-100, ~~withdrew~~starting ~~from~~at the ~~study~~lowest ~~prior~~dose, and toescalating ~~their~~upwards ~~day~~after 85safety ~~visit~~review of the prior dose.

InThe ~~November~~PRTX-100b-103 ~~2013,~~Study ~~following~~proved ~~completion~~difficult to ofenroll ~~the~~due ~~Cohort~~to 4other ~~expansion~~on-going ~~cohorts,~~ITP wePhase ~~initiated~~III ~~enrollment~~studies ~~of the fifth~~ and ~~final~~subsequent ~~cohort~~availability ~~(Cohort~~of 5)two innew ~~the~~and ~~PRTX~~effective ~~100-104~~medicines ~~Study~~for ITP. ~~The~~ ~~Cohort 5 sub-study enrolled 20~~ Nine patients ~~who~~were ~~received~~dosed ~~five~~at ~~weekly~~the ~~fixed-weight~~first ~~doses~~two ofdose ~~PRTX-100~~levels ~~followed~~ by upthe toend ~~four~~of ~~additional monthly~~the ~~maintenance~~first ~~doses~~quarter of ~~PRTX-100~~2009. inAt ~~weeks~~this 8,point ~~12,~~further ~~16,~~recruitment ~~and 20. The primary objective~~ of patients ~~the Cohort 5 sub-study~~ was tosuspended. ~~assess safety~~No ~~and~~side ~~tolerability~~effects ofor ~~these~~toxicities ~~doses~~were ~~administered~~noted onwith arepeated ~~modified~~weekly ~~schedule. Secondary~~doses ~~objectives included determining the effects~~ of PRTX-100 onat ~~measures~~doses of ~~disease~~0.075 ~~activity,~~and ~~assessing~~0.15 micrograms ~~the~~per ~~immunogenicity~~kg ~~and~~that ~~evaluating~~were ~~the~~not PKseen ~~parameters~~with ~~after~~single ~~repeated~~ doses, ~~and~~in ~~determining~~healthy ~~possible~~volunteer ~~relationships~~trials. ~~between~~This ~~the immunogenicity of PRTX~~repeated-~~100~~dose ~~and~~ safety, PKdata ~~and~~from ~~efficacy~~the ~~parameters. In~~PRTX-100b-103 ~~total,~~Study 11was ~~out~~included ~~of 20 patients~~ in ~~Cohort~~the 5clinical ~~completed~~trial ~~all~~application ~~study~~to ~~visits~~evaluate byPRTX-100 ~~August~~in ~~2014~~patients ~~per~~with ~~protocol~~RA.

In ~~November~~March ~~2014~~2015, wethe ~~announced~~FDA ~~final~~accepted ~~data from~~our ~~Cohorts~~IND 1application for ~~through~~a 4Phase ~~and~~I/II anopen-label, ~~interim~~dose-escalating ~~analysis~~study of ~~pooled~~PRTX-100 ~~data~~in ~~from~~adults ~~Cohort~~with 5persistent/chronic ofITP (the ~~104~~“PRTX-100-202 Study”). In ~~For~~June ~~patients~~2015, inthe ~~all~~FDA ~~five~~granted ~~cohorts~~ODD to PRTX-100 for the treatment of ITP. In July 2015, the EMA granted approval for a Phase 1b open-label, dose-escalating study of PRTX-100 in adult patients with persistent/chronic ITP (the ~~104~~“PRTX-100-203 Study”). In September 2015, COMP issued a positive opinion recommending PRTX-100 ~~appeared~~for ~~safe~~designation as an orphan medicinal product for the treatment of ITP. In November 2015, we enrolled our first patient in the PRTX-100-202 Study in the United States and ~~well~~in ~~tolerated~~January 2016 enrolled our first patient in ~~all~~the ~~individuals,~~PRTX ~~including~~100-203 ~~those~~Study ~~who~~in ~~developed~~Europe. ~~ADAs,~~Enrollment is continuing in the PRTX-100-202 Study at study sites in both the U.S. and the AEUK and the PRTX-100-203 Study in the UK. In August 2017, OOPD awarded us a grant ~~profile~~of ~~was~~$403,000 ~~consistent~~to ~~with~~support ~~our~~the ~~prior~~future clinical ~~trial~~development ~~results~~of PRTX-100 as a treatment for ITP.

InRheumatoid ~~the~~arthritis ~~Cohort 5 sub~~-~~study,~~ ~~the amount of PRTX-100 administered~~RA ~~and~~is ~~its~~a ~~dosing~~highly ~~frequency~~inflammatory ~~were~~polyarthritis ~~varied~~often ~~from~~leading ~~Cohorts 1 through 4~~ to ~~explore~~joint ~~effects on safety~~destruction, ~~tolerability~~deformity and ~~measures~~loss of ~~disease activity~~function. In ~~total,~~addition ~~twenty patients were randomized~~ to ~~420~~characteristic symmetric µgswelling ~~PRTX-100~~of ~~(12~~peripheral ~~patients)~~joints, ~~240~~systemic µgsymptoms ~~PRTX-100~~related (3to ~~patients) or~~chronic ~~placebo~~inflammation (5can ~~patients)~~commonly occur. ~~The~~Chronic ~~addition~~pain, ofdisability and ~~four~~excess ~~monthly~~mortality ~~maintenance~~are ~~doses~~unfortunate ~~after~~sequelae. ~~the~~RA ~~five~~is ~~weekly doses did not increase~~ the ~~rate~~most ~~or type~~common ofautoimmune ~~AEs~~disease, ~~even~~affecting in1% ~~those~~to ~~patients~~2% ~~who~~of ~~developed~~the ~~ADAs~~world’s population, ~~nor~~with ~~indicate~~prevalence ~~any~~rising ~~apparent~~with ~~correlation~~age ~~between~~to ~~the~~about ~~development~~5% ofin ~~ADAs~~women ~~and effects~~over ~~on measures of RA disease activity~~55.

InPRTX-100 ~~addition,~~shows ~~Cohort~~measurable 5activity ~~patients~~in ~~showed~~a ~~improvement~~standard mouse model of inautoimmune ~~measures~~arthritis. A substantial body of ~~disease~~published ~~activity,~~literature ~~including~~and ~~ACR20~~proprietary ~~scores~~data delineate the immunomodulatory activities of PRTX-100, ~~compared~~which toare ~~Cohort~~distinct 1from ~~through~~those 4of ~~patients~~current ~~who~~major ~~did~~biologic ~~not~~treatments ~~receive~~for ~~any~~rheumatoid ~~monthly maintenance~~arthritis. ~~doses~~Accordingly, ~~suggesting~~we believe that ~~the~~RA ~~addition~~represents ofa ~~monthly~~potentially ~~maintenance~~important ~~administration~~clinical ofindication for treatment with PRTX-100. ~~and~~While ~~weight-based~~recent ~~dosing~~advances ~~were~~in biologic treatments anfor ~~important~~RA ~~aspect~~have ofimproved the ~~dosing~~prognosis ~~protocol~~for ~~and~~many ~~should~~patients, bemany ~~considered~~others incontinue ~~future~~to ~~trials~~live ofwith ~~PRTX-100.~~debilitating ARA ~~total~~disease ofactivity 61due ~~patients enrolled~~either ~~across~~to the ~~five~~cost, ~~cohorts in the PRTX 100~~side-~~104~~effects, ~~Study~~or atlimited ~~nine~~effectiveness ~~study~~of ~~sites~~these innewer ~~the United States~~therapies.

The PRTX-100-~~105~~103 Study

In ~~February~~August ~~2015~~2010, we commenced ~~enrollment, at~~ a ~~single~~multi-center Phase ~~U.S.~~1b ~~site,~~clinical trial of aPRTX-100 ~~Phase~~in ~~I/II~~South ~~open-label,~~Africa ~~multiple,~~on ~~fixed-dose~~adult ~~study~~patients ~~(the~~with ~~“PRTX-100-105~~active ~~Study”)~~RA ~~which~~on ~~was open~~methotrexate ~~only~~or toleflunomide. The PRTX-100-~~104~~ 103 Study ~~patients~~served ~~who~~to ~~indicated~~evaluate ~~their~~safety ~~desire~~and ~~for~~potential ~~additional~~efficacy ~~treatment.~~of ~~The~~ PRTX-100~~-105~~ ~~Study~~in patients with active RA and was anapproved ~~open-label, single~~to ~~group~~enroll ~~study~~up ~~with~~to 40 ~~former~~patients ~~participants~~in ~~from~~four ~~the~~dose-escalating ~~104~~cohorts. ~~Study~~In ~~who~~January ~~were~~2012, ~~eligible~~we tocompleted ~~receive~~patient adosing ~~fixed~~in ~~dose~~the fourth cohort of the PRTX-100 ~~over a 6~~-~~month~~103 ~~period~~Study. ~~The~~A ~~primary~~total ~~study~~of ~~endpoint~~37 ofpatients ~~the~~were ~~105~~enrolled ~~Study~~in ~~was~~four ~~the~~cohorts ~~safety~~ranging ~~and~~from ~~tolerability~~0.15 ofmicrograms/kg ato ~~fixed~~1.50 ~~dose~~micrograms/kg of PRTX-100 or placebo, administered ~~over an~~weekly ~~extended~~for ~~period~~four weeks. ~~The~~Measures ~~secondary~~of ~~endpoints~~safety, ~~included immunogenicity~~PK, ~~effects~~and ondisease ~~measures~~activity ofwere RAevaluated ~~disease~~over ~~activity,~~16 ~~evaluation~~weeks offollowing ~~anti~~the first dose. The PRTX-100-103 Study results demonstrated that PRTX-100 ~~antibody~~was ~~presence,~~generally safe and ~~feasibility~~well-tolerated ofin ~~joint~~patients ~~evaluations~~ with active ~~ultrasound~~RA ~~and~~at ~~biomarkers~~all astested ~~disease~~dose ~~markers.~~levels Aand ~~total of~~at ~~eight~~the ~~patients~~higher ~~completed~~doses, ~~all~~decreased ~~105~~RA ~~Study~~activity ~~visits~~as ~~per~~scored ~~protocol~~by the CDAI.

InThe ~~the~~number ~~PRTX-100-105~~of ~~Study, a preliminary interim analysis indicated that for~~ patients ~~who~~with ~~completed~~a ~~per protocol, PRTX~~DAS28-~~100~~CRP ~~exhibited~~< 3.2 an(Disease ~~acceptable~~Activity ~~safety~~Score) ~~profile~~at ~~and~~six ~~RA disease~~weeks ~~activity~~ was ~~improved~~the inpredefined adisease ~~majority~~activity ofendpoint ~~patients at the end~~ of the study ~~as compared to baseline~~. NoThe ~~SAEs~~results ~~were~~showed ~~reported. At~~that ~~study day 196, one month after~~ the ~~final dose,~~ patients ~~who~~receiving ~~completed~~PRTX-100 ~~the~~were ~~study~~more ~~per~~likely ~~protocol~~to ~~demonstrated~~respond athan ~~mean~~those ~~reduction~~receiving ~~of the~~placebo ~~DAS28CRP~~at ~~score~~all ~~from 5.25 to 2.52~~times, ~~suggesting~~the anumber ~~clinically~~of ~~meaningful~~responders ~~improvement in disease activity. Additionally, clinical~~increased ~~assessment~~over bytime ~~UPD,~~during ~~also~~the ~~revealed~~16 aweek ~~reduction~~study inevaluation ~~average disease severity by day 196~~period, and that the ~~correlation~~maximum ~~between~~tolerated ~~the~~dose ~~UPD~~was ~~and~~not reached at the ~~DAS28CRP~~ ~~was~~highest ~~r=0.624~~dose ~~(p<~~level.~~0005).~~

18 19

~~The~~Additionally, the results indicate that PRTX-100 did not change CRP (C-~~202~~Reactive ~~Study~~Protein) levels, even in those patients whose swollen and tender joint count and global VAS (Visual Analogue Scale) scores had decreased to low levels after treatment. Because of the influence of the CRP component on the DAS28-CRP score, a post-hoc analysis was performed examining changes in the CDAI scores in all patients. The CDAI score does not evaluate CRP as a component, but instead comprises physician and patient-assessed chemical markers of disease activity. In the placebo, 0.15 micrograms/kg, and 0.45 micrograms/kg dose groups, one out of eight patients in each group attained low disease activity (CDAI ≤ 10) on two or more consecutive visits. In the 0.90 micrograms/kg and 1.50 micrograms/kg dose groups, two of eight and two of five patients, respectively, attained this same endpoint, and maintained a CDAI < 10 until the week 16 final visit. Of the four apparent responders in the 1.50 micrograms/kg group, two attained a CDAI ≤ 6 (remission), one attained a CDAI ≤ 10 (low activity), and one achieved a CDAI of 10.1 at one or more visits. The mean time to peak response in this group occurred six weeks after their last dose.

InThe ~~November~~disease ~~2015,~~activity weresults ~~commenced~~from ~~enrollment and enrolled our first patient in~~ the PRTX-100-~~202~~ 103 Study. ~~The~~demonstrated ~~PRTX-100-202~~an ~~Study~~acceptable ~~may~~safety ~~enroll~~profile, upand tosuggested 36treatment ~~patients~~with ~~in as many as six cohorts. Each patient will receive four weekly intravenous doses of~~ PRTX-100 ~~and~~could ~~will~~affect bedisease ~~monitored~~activity, ~~for~~although these upeffects towere 48not ~~weeks~~statistically ~~thereafter~~significant. ~~The~~ ~~primary~~In ~~study~~November ~~endpoint~~2012 ofwe commenced the PRTX-100-~~202~~104 Study ~~is a platelet response~~ to ~~PRTX-100.~~provide ~~Secondary~~a ~~endpoints~~better ~~include~~understanding of safety, ~~immunogenicity,~~ and ~~pharmacokinetics.~~potential ~~One~~treatment ~~patient~~effect inon ~~each~~RA ofdisease ~~the~~activity ~~two~~measurements ~~completed~~as ~~cohorts~~well ofas ~~the~~to ~~PRTX-100-202~~help ~~Study~~define ~~had a platelet response per protocol. Enrollment is continuing for patients in~~ the ~~third~~optimal ~~cohort in the PRTX-100-202 Study at an increased~~ dose.

The PRTX-100-~~203~~104 Study

In ~~January~~November ~~2016~~2012, we commenced enrollment in ofthe ~~our~~United ~~first~~States ~~patient~~for ina ~~the~~new ~~European~~multicenter ~~based~~Phase ~~PRTX~~1b randomized, multiple-~~100~~dose, dose-~~203~~escalation ~~Study.~~study ~~The~~(the “PRTX-100-~~203~~104 Study”) of ~~may~~PRTX-100 ~~enroll~~in upcombination towith 30methotrexate ~~patients~~or leflunomide in asadult ~~many~~patients ~~as five~~with ~~cohorts~~active RA. ~~Each~~The ~~patient~~sequential ~~will~~dose-escalation ~~receive~~phase of ~~four~~this ~~weekly~~study ~~intravenous~~was ~~doses~~expected ofto ~~PRTX-100~~enroll ~~and~~up ~~will~~to be40 ~~monitored~~patients ~~for~~into upfive tocohorts 48ranging ~~weeks~~from ~~thereafter~~1. ~~The~~50 ~~primary~~micrograms/kg ~~study~~up ~~endpoints~~to 18.0 micrograms/kg of ~~the~~ PRTX-100~~-203~~ ~~Study~~or ~~include~~placebo. ~~safety~~At each dose, ~~immunogenicity~~one ~~and~~quarter ~~pharmacokinetics.~~of ~~Secondary~~patients ~~endpoints include~~would ~~platelet~~receive ~~response~~a ~~and~~placebo ~~duration~~treatment. ~~One~~Similar ~~patient~~to inthe PRTX-100-103 Study, the ~~first~~primary ~~cohort~~objective of the PRTX-100-~~203~~104 Study ~~had~~was ato ~~platelet~~assess ~~response~~the ~~per~~safety ~~protocol.~~and tolerability of intravenous PRTX-100 administered Inweekly ~~addition,~~over wefive ~~recently~~weeks ~~opened~~in ~~seven~~patients ~~new~~with ~~clinical~~active ~~study~~RA ~~sites~~on inmethotrexate or leflunomide therapy. The secondary objectives included determining the ~~United~~effects ~~Kingdom~~of PRTX-100 on measures of disease activity, assessing the immunogenicity and ~~dosed~~evaluating the ~~first~~PK ~~patient.~~parameters ~~Enrollment~~after isrepeated ~~continuing~~doses, ~~for~~and ~~patients~~determining inpossible ~~the~~relationships ~~third~~between ~~cohort~~the inimmunogenicity ~~the~~of PRTX-100~~-203~~ ~~Study~~and atsafety anand ~~increased dose~~PK.

~~Manufacturing~~In August 2013, following a planned interim safety review by our Independent Data Safety Monitoring Committee and upon completion of the fourth cohort, we expanded the 3.0 microgram, 6.0 microgram, and 12.0 micrograms/kg dose cohorts of the PRTX-100-104 Study. An additional nine patients were enrolled in the expansion cohort that was completed in October 2013. In total, the first four dose-escalating cohorts of the PRTX-100-104 Study, which included these three expanded cohorts, enrolled 41 patients at five U.S. clinical centers with doses ranging from 1.5 micrograms/kg up to 12.0 micrograms/kg. Five patients withdrew from the study prior to their day 85 visit.

WeIn ~~currently~~November ~~contract~~2013, ~~the~~following ~~manufacturing~~ completion of ~~our lead drug substance PRTX-100 to Eurogentec S.A. in Belgium where it is produced under Current Good Manufacturing Practice,~~the orCohort ~~cGMP,~~4 ~~conditions.~~expansion ~~Specifically~~cohorts, we ~~contract~~initiated ~~with~~enrollment ~~Eurogentec~~of ~~for~~ the ~~manufacture~~fifth ofand ~~additional~~final ~~bulk~~cohort ~~drug substance~~ (~~our~~Cohort ~~“active pharmaceutical ingredients”~~5) ~~(“API”), which we believe is~~ in ~~sufficient~~the ~~supply~~PRTX ~~for~~100-104 ~~completion of our current clinical studies~~Study. The ~~stability~~Cohort 5 ~~testing~~sub-study ~~and~~enrolled ~~packaging~~20 ofpatients ~~the~~who ~~final~~received ~~drug~~five ~~product~~weekly ~~for~~fixed-weight ~~clinical~~doses ~~supplies~~of isPRTX-100 ~~performed~~followed by ~~Eurogentec. The~~up ~~packaging~~to offour ~~the~~additional ~~final~~monthly maintenance ~~drug~~doses ~~product~~of ~~is conducted at separate FDA~~PRTX-~~approved~~100 ~~facilities.~~in ~~These~~weeks ~~companies~~8, in12, ~~the aggregate~~16, ~~have provided~~and ~~the~~20. ~~drug~~The ~~product~~primary ~~for~~objective ~~both~~of ~~toxicological~~the ~~testing~~Cohort ~~and~~5 ~~clinical~~sub-study ~~supplies.~~was Weto ~~believe~~assess ~~that this entire process is scaleable~~safety toand ~~commercial~~tolerability ~~production~~of ~~but~~these ~~will~~doses ~~require~~administered ~~additional~~on ~~manufacturing~~a ~~resources~~modified schedule. Secondary ~~The~~objectives ~~original~~included ~~three~~determining ~~clinical~~the ~~trials~~ effects of PRTX-100 ~~were conducted~~on ~~with~~measures aof ~~liquid~~disease ~~formulation~~activity, ~~and~~assessing ~~all~~the ~~subsequent~~immunogenicity ~~studies~~and ~~have~~evaluating ~~utilized~~the aPK ~~newer~~parameters ~~lyophilized~~after ~~formulation~~repeated ~~designed to achieve~~doses, ~~better stability~~ and ~~longer~~determining ~~product~~possible ~~shelf-life.~~relationships ~~Compared~~between tothe ~~therapeutic~~immunogenicity ~~doses~~ of ~~other~~PRTX-100 ~~biologic~~and ~~products~~safety, ~~used~~PK toand ~~treat~~efficacy RAparameters. ~~and~~In ~~ITP~~total, we11 ~~believe~~out ~~the overall costs for these proposed therapeutic doses~~ of ~~PRTX-100~~20 ~~are~~patients ~~significantly~~in ~~less~~Cohort ~~due~~5 tocompleted ~~the~~all ~~low~~study ~~dose~~visits ~~and~~by ~~the simplicity~~August of2014 ~~drug~~per ~~substance manufacture~~protocol.

~~Markets~~In November 2014, we announced final data from Cohorts 1 through 4 and an interim analysis of pooled data from Cohort 5 of the 104 Study. For patients in all five cohorts of the 104 Study, PRTX-100 appeared safe and well tolerated in all individuals, including those who developed ADAs, and the AE profile was consistent with our prior clinical trial results.

RAIn isthe ~~our~~Cohort ~~most~~5 ~~advanced~~sub-study, ~~primary~~the ~~indication. RA~~amount isof aPRTX-100 ~~serious~~administered ~~autoimmune~~and its ~~disorder~~dosing ~~that~~frequency ~~causes~~were ~~the~~varied ~~body’s~~from ~~immune~~Cohorts ~~system~~1 tothrough ~~produce~~4 ~~antibodies~~to ~~that~~explore ~~attack~~effects ~~the~~on ~~lining of the joints~~safety, ~~resulting~~tolerability ~~in inflammation~~ and ~~pain.~~measures RAof ~~can~~disease ~~lead~~activity. In ~~to joint deformity or destruction~~total, ~~organ~~twenty ~~damage,~~patients ~~disability~~were ~~and~~randomized ~~premature death. According~~ to ~~both~~420 ~~the~~µg ~~Arthritis~~PRTX-100 ~~Foundation~~(12 ~~and~~patients), ~~the~~240 ~~American~~µg ~~College~~PRTX-100 of(3 ~~Rheumatology~~patients) ~~websites,~~or ~~approximately~~placebo (5 1patients).5 ~~million people~~The inaddition ~~the~~of ~~United~~four ~~States~~monthly ~~have~~maintenance ~~RA,~~doses ~~which~~after isthe ~~approximately~~five 1%weekly ofdoses ~~the~~did ~~nation’s~~not ~~adult~~increase ~~population.~~the ~~There~~rate ~~are~~or ~~nearly~~type ~~three~~of ~~times~~AEs, aseven ~~many~~in ~~women~~those aspatients ~~men~~who ~~with~~developed ~~the~~ADAs ~~disease.~~nor ~~The~~indicate ~~disease~~any ~~occurs~~apparent incorrelation ~~all~~between ~~ethnic~~the ~~groups~~development ~~and~~of inADAs ~~every~~and ~~part~~effects on measures of ~~the~~RA ~~world~~disease activity.

RA was chosen as a target disease because it represents a well-defined, rapidly growing market for which there is no current uniformly effective treatment. Sixty percent of people with inadequately treated RA are unable to work 10 years after onset. It is estimated that despite treatment with current approved RA therapeutics, at least one-third of patients continue to have significant disability and limitations due to their disease. Current treatments are costly, some are associated with increased risk of cancer and opportunistic infections, and in most cases must be continued for decades. The market for the existing biologic RA drugs is primarily limited to those countries that have a high per capita income because treatment can cost tens of thousands of dollars per patient per year. Thus, a large portion of the world’s patient population cannot afford the existing biologic RA drugs. In contrast, we believe that PRTX-100 could potentially provide patients with a therapy that is efficacious, cost-effective, and has a highly favorable benefit-risk ratio.20

~~Once~~In ~~further~~addition, ~~developed~~Cohort ~~and~~5 ~~approved,~~patients weshowed improvement ~~believe~~in ~~that~~measures ~~PRTX-100~~of ~~could~~disease beactivity, ~~used~~including toACR20 ~~treat~~scores, ~~patients~~compared ~~with~~to ~~moderate~~Cohort to1 ~~severe~~through ~~cases~~4 ofpatients ~~RA,~~who ~~and~~did ~~particularly~~not ~~those~~receive ~~individuals~~any ~~for~~monthly ~~whom~~maintenance ~~other~~doses, ~~treatments~~suggesting ~~failed.~~that ~~Given~~ the ~~differences~~addition inof ~~the~~monthly ~~regulatory~~maintenance ~~approval~~administration ~~process~~of inPRTX-100 ~~different~~and ~~parts~~weight-based dosing were an important aspect of the ~~world,~~dosing itprotocol isand ~~reasonable to~~should ~~believe~~be ~~that~~considered in future trials of PRTX-100. ~~might~~A ~~first~~total beof ~~used~~61 patients enrolled across the five cohorts in the ~~developing~~PRTX ~~world~~100-104 ~~and~~Study ~~then~~at innine ~~Europe~~study ~~and~~sites ~~North~~in ~~America~~the United States.

InThe ~~addition, we believe ITP also represents a potential indication for~~ PRTX-100. ITP or Immune thrombocytopenia is a bleeding disorder in which the immune system destroys platelets, which are necessary for normal blood clotting. Persons with the disease have too few platelets in the blood. ITP affects women more often than men, and it is more common in children than in adults. In children, the disease usually resolves without treatment. Adults are usually treated with an anti-~~inflammatory~~105 ~~steroid medicine (prednisone). In some cases, surgery to remove the spleen (splenectomy) is recommended which increases the platelet count in about half of patients.~~Study

19 In February 2015, we commenced enrollment, at a single U.S. site, of a Phase I/II open-label, multiple, fixed-dose study (the “PRTX-100-105 Study”) which was open only to PRTX-100-104 Study patients who indicated their desire for additional treatment. The PRTX-100-105 Study was an open-label, single group study with former participants from the 104 Study who were eligible to receive a fixed dose of PRTX-100 over a 6-month period. The primary study endpoint of the 105 Study was the safety and tolerability of a fixed dose of PRTX-100 administered over an extended period. The secondary endpoints included immunogenicity, effects on measures of RA disease activity, evaluation of anti-PRTX-100 antibody presence, and feasibility of joint evaluations with ultrasound and biomarkers as disease markers. A total of eight patients completed all 105 Study visits per protocol.

~~ITP~~In ~~has~~the noPRTX-100-105 ~~known cure~~Study, ~~and~~a ~~relapses~~preliminary ~~may~~interim ~~occur~~analysis ~~years~~indicated ~~after~~that ~~seemingly~~for ~~successful~~patients ~~medical~~who orcompleted ~~surgical~~per ~~management.~~protocol, IfPRTX-100 ~~the~~exhibited ~~patient’s~~an ~~condition~~acceptable ~~does~~safety ~~not~~profile ~~improve~~and ~~with~~RA ~~the~~disease ~~use~~activity ofwas ~~prednisone,~~improved in a ~~corticosteroid~~majority ~~drug~~of ~~that~~patients isat the ~~first~~end ~~line~~of ~~therapy~~the ~~for~~study ~~ITP,~~as ~~other~~compared ~~treatments~~to ~~may~~baseline. ~~include:~~No ~~danazol~~SAEs ~~(Danocrine), a~~were ~~drug~~reported. ~~taken~~At bystudy day ~~mouth;~~196, ~~infusions~~one ofmonth ~~high-dose~~after ~~gamma~~the ~~globulin~~final ~~(an~~dose, ~~immune~~patients ~~factor);~~who ~~drugs~~completed ~~that suppress~~ the ~~immune~~study ~~system;~~per ~~anti-RhD therapy~~protocol ~~for~~demonstrated ~~people~~a ~~with~~mean ~~certain~~reduction ~~blood~~of ~~types;~~the ~~and newer agents like romiplostim (Nplate) and eltrombopag (Promacta) that stimulate~~DAS28CRP ~~the~~score ~~bone~~from ~~marrow~~5.25 to ~~make more platelets~~2.52, ~~Global~~suggesting ~~sales~~a ofclinically ~~Nplate~~meaningful ~~and~~improvement ~~Promacta were approximately $584 million and $635 million, respectively,~~ in ~~2016~~disease activity. ~~Neither romiplostim nor eltrombopag impact the principal pathological mechanism of ITP~~Additionally, ~~namely~~clinical ~~immune-mediated plated~~assessment ~~destruction~~by UPD, ~~and~~also werevealed ~~believe that PRTX-100 may have~~ a ~~more~~reduction ~~direct~~in ~~impact~~average ondisease ~~ITP~~severity ~~disease~~by ~~processes.~~day ~~Thus~~196, weand ~~believe~~the ~~that~~correlation ~~PRTX-100 may~~between ~~complement~~the orUPD ~~reduce~~and the ~~use~~DAS28CRP was ofr=0.624 ~~thrombopoeitic agents in adult patients with ITP~~(p<.0005).

~~Preliminary~~The ~~information gained in the laboratory on the mechanism of action of~~ PRTX-100 also suggests potential efficacy in a range of autoimmune and inflammatory diseases, including, but not limited to psoriasis, myasthenia gravis (MG), chronic idiopathic demyelinating polyneuropathy, and pemphigus. We recently completed a study of PRTX-~~100~~202 in an animal model of MG and expect to initiate a second confirmatory study and have top-line results in the 1st quarter of 2018. MG is an autoimmune disorder caused by anti-self antibodies that react with the neuromuscular junction causing muscle weakness and fatigability.Study

~~Our~~In ~~long-term~~November ~~strategy~~2015, ~~contemplates~~we commenced enrollment and enrolled our first patient in the ~~pursuit~~PRTX-100-202 Study. The PRTX-100-202 Study may enroll up to 36 patients in as many as six cohorts. Each patient will receive four weekly intravenous doses of ~~FDA~~PRTX-100 ~~approval~~and will be monitored for up to 48 weeks thereafter. The primary study endpoint of the PRTX-100-202 Study is a platelet response to ~~treat~~PRTX-100. ~~other~~Secondary ~~autoimmune~~endpoints include safety, immunogenicity, and ~~inflammatory~~pharmacokinetics. ~~diseases~~One patient in ~~addition~~each toof RAthe first two cohorts of the PRTX-100-202 Study has had a platelet response per protocol. Enrollment is continuing for patients in the fourth cohort in the PRTX-100-202 Study at an increased dose at study sites in both the U.S. and ~~ITP~~the UK.

~~Competition~~The PRTX-100-203 Study

WeIn ~~believe~~January 2016, ~~based~~we oncommenced ~~the~~enrollment ~~pre-clinical trials and the results to date~~ of our ~~five~~first ~~Phase~~patient Iin RAthe ~~clinical~~European ~~studies,~~based ~~that~~ PRTX-100-203 ~~has~~Study. aThe ~~potential~~PRTX-100-203 ~~competitive~~Study ~~advantage~~may asenroll itup ~~may be~~to ~~safer~~30 ~~and~~patients ~~more~~in ~~efficacious~~as ~~than~~many ~~existing~~as RAfive cohorts. ~~therapies,~~Each ~~and~~patient ~~may~~will ~~cost~~receive ~~less~~four toweekly ~~manufacture~~intravenous ~~than~~doses ~~competing~~of ~~biologic~~PRTX-~~based~~100 ~~therapies. Current RA treatments are characterized by complex manufacturing methods~~ and, inwill ~~2016,~~be ~~resulted~~monitored infor anup ~~average~~to ~~annual~~48 ~~retail~~weeks ~~cost~~thereafter. ofThe ~~approximately~~primary ~~$13,000~~study toendpoints ~~$30,000~~of ~~per patient, if~~ the ~~newer disease~~PRTX-~~modifying anti~~100-~~rheumatic~~203 ~~drugs~~Study ~~approved~~include insafety, ~~the~~immunogenicity ~~last~~and 20pharmacokinetics. ~~years~~Secondary endpoints ~~were~~include ~~used. The~~platelet ~~cost~~response ~~can~~and ~~increase~~duration. ~~according~~Two topatients in the ~~size/weight~~PRTX-100-203 ofStudy ahave ~~patient~~had ~~and~~a ~~the~~platelet ~~number~~response ofper ~~doses required~~protocol. ~~Additionally,~~Following ~~patients are faced with~~ the ~~cost~~recommendation of ~~the~~our ~~infusion~~Safety ~~itself~~ and ~~blood~~Monitoring ~~tests~~Committee ~~which~~upon ~~are~~evaluating ~~often~~safety ~~not~~data ~~included~~from inthe ~~those~~fifth ~~cost~~dosage ~~estimates. Several~~cohort ~~pharmaceutical~~of ~~agents~~24 ~~are currently being used~~mg/kg, enrollment ~~with~~is ~~varying~~continuing ~~degrees~~for ofup ~~success,~~ to ~~control~~three ~~the~~additional ~~signs~~patients ~~and~~in ~~symptoms~~the of18 ~~RA and~~mg/kg ~~slow~~dosage ~~its progression~~cohort. ~~Available treatment options include:~~

~~· Analgesic/anti-inflammatory preparations, ranging from simple aspirin to the COX-2 inhibitors;~~Manufacturing

·We ~~Immunosuppressive/antineoplastic~~currently ~~drugs~~contract the manufacturing of our lead drug substance PRTX-100 to Eurogentec S.A. in Belgium where it is produced under Current Good Manufacturing Practice, or ~~including~~cGMP, ~~azathioprine~~conditions. Specifically, we contract with Eurogentec for the manufacture of additional bulk drug substance (our “active pharmaceutical ingredients”) (“API”), which we believe is in sufficient supply for completion of our current clinical studies. The stability testing and ~~methotrexate;~~packaging of the final drug product for clinical supplies is performed by Eurogentec. The packaging of the final drug product is conducted at separate FDA-approved facilities. These companies, in the aggregate, have provided the drug product for both toxicological testing and clinical supplies. We believe that this entire process is scaleable to commercial production but will require additional manufacturing resources. The original three clinical trials of PRTX-100 were conducted with a liquid formulation and all subsequent studies have utilized a newer lyophilized formulation designed to achieve better stability and longer product shelf-life. Compared to therapeutic doses of other biologic products used to treat RA and ITP, we believe the overall costs for these proposed therapeutic doses of PRTX-100 are significantly less due to the low dose and the simplicity of drug substance manufacture.

· TNF (Tumor Necrosis Factor) inhibitors, also known as anti-TNF therapy, currently represented by etanercept (Enbrel®), infliximab (Remicade®), and adalimumab (Humira®) and the newer entries, certolizumab (Cimzia®) and golimumab (Simponi®);21

~~· Soluble Interleukin-l (IL-I) Receptor Therapy, Anakinra (Kineret®) and (Il-6) tocilizumab (Actemra®);~~Markets

·RA ~~Costimulatory~~is ~~molecule~~our ~~inhibitor~~most ~~abatacept~~advanced ~~(Orencia®);~~primary indication. RA is a serious autoimmune disorder that causes the body’s immune system to produce antibodies that attack the lining of the joints, resulting in inflammation and pain. RA can lead to joint deformity or destruction, organ damage, disability and premature death. According to both the Arthritis Foundation and the American College of Rheumatology websites, approximately 1.5 million people in the United States have RA, which is approximately 1% of the nation’s adult population. There are nearly three times as many women as men with the disease. The disease occurs in all ethnic groups and in every part of the world.

·RA ~~Anti~~was ~~CD20~~chosen Bas a target disease because it represents a well-~~cell~~defined, rapidly growing market for which there is no current uniformly effective treatment. Sixty percent of people with inadequately treated RA are unable to work 10 years after onset. It is estimated that despite treatment with current approved RA therapeutics, at least one-~~directed~~third ~~therapy~~of patients continue to have significant disability and limitations due to their disease. Current treatments are costly, ~~rituximab~~some ~~(Rituxan®);~~are associated with increased risk of cancer and opportunistic infections, and in most cases must be continued for decades. The market for the existing biologic RA drugs is primarily limited to those countries that have a high per capita income because treatment can cost tens of thousands of dollars per patient per year. Thus, a large portion of the world’s patient population cannot afford the existing biologic RA drugs. In contrast, we believe that PRTX-100 could potentially provide patients with a therapy that is efficacious, cost-effective, and has a highly favorable benefit-risk ratio.

·Once ~~Janus~~further ~~Kinase~~developed ~~(JAK)~~and ~~inhibitor~~approved, ~~tofacitinib~~we ~~citrate~~believe that ~~(Xeljanz)~~PRTX-100 could be used to treat patients with moderate to severe cases of RA, and particularly those individuals for whom other treatments failed. Given the differences in the regulatory approval process in different parts of the world, it is reasonable to believe that PRTX-100 might first be used in the developing world and then in Europe and North America.

~~Many~~In ~~large and small pharmaceutical companies are active in this market~~addition, ~~with~~we ~~Amgen~~believe ~~Corporation~~ITP ~~(with~~also ~~Pfizer), Johnson & Johnson, Inc. (with Merck) and Abbott Laboratories~~represents ~~dominating~~a ~~the~~potential ~~market~~indication for ~~biologic therapies with their respective products, Enbrel®, Remicade® and Humira®~~PRTX-100. ~~According~~ toITP ~~each~~or ~~company’s~~Immune ~~2016~~thrombocytopenia ~~annual~~is ~~report,~~a ~~Enbrel~~bleeding ~~generated~~disorder ~~revenues~~in ofwhich ~~approximately~~the ~~$8.9~~immune ~~billion~~system ~~combined for Amgen~~destroys ~~and Pfizer~~platelets, ~~Remicade~~which ~~generated~~are ~~revenues~~necessary offor ~~more~~normal ~~than~~blood $8clotting.2 ~~billion~~Persons ~~combined~~with ~~for~~the ~~Johnson~~disease &have ~~Johnson~~too ~~and~~few ~~Merck,~~platelets ~~and~~in ~~AbbVie~~the ~~reported generated revenues of over $16 billion for Humira~~blood. ~~For~~ ~~other~~ITP ~~TNF inhibitors, Cimzia generated revenues of $1.4 billion for~~affects ~~UCB;~~women ~~Simponi~~more ~~generated~~often ~~revenues~~than ofmen, ~~$2.5 billion for Johnson & Johnson~~ and ~~Merck;~~it ~~and~~is ~~Orencia~~more ~~generated~~common ~~revenues~~in ofchildren ~~$2.3~~than ~~billion for~~in ~~Bristol Myers Squibb~~adults. ~~Kineret~~ ~~generated~~In ~~revenues of $114 million in sales for SOBI~~children, ~~which acquired from Amgen~~ the ~~rights to~~disease ~~develop~~usually ~~and~~resolves ~~commercialize Kineret in 2014~~without treatment. ~~Actemra~~ ~~generated~~Adults ~~revenues~~are ofusually ~~$1.7~~treated ~~billion~~with ~~for~~an ~~Roche.~~anti-inflammatory ~~Also~~steroid ~~for~~medicine ~~Roche, Rituxan earned $1~~(prednisone).5 ~~billion~~In ~~for~~some ~~the treatment of RA alone~~cases, ~~and~~surgery ~~billions~~to ~~more for other indications. Xeljanz nearly doubled its earnings~~remove ~~for~~the ~~Pfizer~~spleen ~~from~~(splenectomy) ~~$523~~is ~~million~~recommended inwhich ~~2015~~increases tothe ~~$927~~platelet ~~million~~count in ~~2016.~~about ~~Revenue~~half ~~figures above reflect the use~~ of ~~these drugs for RA, other indications and off label uses~~patients.

20 ITP has no known cure, and relapses may occur years after seemingly successful medical or surgical management. If the patient’s condition does not improve with the use of prednisone, a corticosteroid drug that is the first line therapy for ITP, other treatments may include: danazol (Danocrine), a drug taken by mouth; infusions of high-dose gamma globulin (an immune factor); drugs that suppress the immune system; anti-RhD therapy for people with certain blood types; and newer agents like romiplostim (Nplate) and eltrombopag (Promacta) that stimulate the bone marrow to make more platelets. Global sales of Nplate and Promacta were approximately $584 million and $635 million, respectively, in 2016. Neither romiplostim nor eltrombopag impact the principal pathological mechanism of ITP, namely immune-mediated plated destruction, and we believe that PRTX-100 may have a more direct impact on ITP disease processes. Thus, we believe that PRTX-100 may complement or reduce the use of thrombopoeitic agents in adult patients with ITP.

~~Post–marketing~~Preliminary ~~experience~~information ~~has~~gained ~~indicated that~~in ~~current~~the ~~and~~laboratory on ~~newly-marketed~~the ~~disease~~mechanism ~~modifying anti-rheumatic drugs (DMARDs) subject patients to an increased risk~~ of ~~certain SAEs. Products which inhibit the~~ action of ~~TNF~~PRTX-~~alpha,~~100 ~~being~~also ~~the~~suggests ~~longest~~potential onefficacy ~~the~~in ~~market~~a ~~and~~range ~~the most studied, have demonstrated an increased incidence~~ of ~~certain~~autoimmune ~~SAEs. Due to suppression of the immune system by these products, these SAEs include serious~~ and ~~opportunistic~~inflammatory ~~infections such as tuberculosis~~diseases, ~~fungal infections~~including, ~~and listeria infection, and increased risk of lymphomas.~~ ~~Transient~~but ~~neutropenia and other blood dyscrasias have been reported. TNF inhibitors are also~~ not ~~recommended~~limited into ~~patients with~~psoriasis, ~~demyelinating~~myasthenia ~~disease~~gravis ~~or with congestive heart failure. Rituxan~~ (~~anti-CD20~~MG), ~~use~~chronic ~~increases~~idiopathic ~~the~~demyelinating ~~potential~~polyneuropathy, ~~for~~and ~~Hep~~pemphigus. BWe ~~reactivation~~recently ~~and~~completed ~~multifocal leukoencephalopathy,~~ a ~~fatal~~second ~~viral~~confirmatory ~~disease. Kineret~~study ~~(IL-1) also shows an increased the risk~~ of ~~infection. Actemra (IL~~PRTX-6)100 ~~use~~in ~~has led to increased liver enzyme levels, hypertension, transient neutropenia, and~~ an ~~increase~~animal inmodel ~~cholesterol levels. Orencia (T cell inhibition) also works by weakening the immune system, therefore can increase the risk~~ of ~~infections. Patients~~MG ~~using Orencia have developed lymphoma~~ and ~~lung~~expect ~~cancer. Xeljanz (JAK) is the newest RA treatment~~ to ~~enter~~have ~~the~~top-line ~~market. It~~results ~~has~~in ~~demonstrated similar side effects to TNF inhibitors, including invasive and opportunistic infections and~~ the ~~reactivation~~2nd quarter of ~~tuberculosis~~2018. ~~Lymphomas~~ ~~and~~MG ~~other~~is ~~malignancies~~an ~~have~~autoimmune ~~been~~disorder ~~observed~~caused ~~in patients treated with Xeljanz. In a study~~ by a ~~Swedish~~anti-self ~~research~~antibodies ~~group~~that ~~published~~react ~~in November 2012 by the American College of Rheumatology entitled, “Mortality Rates in Patients~~ with ~~Rheumatoid Arthritis Treated with Tumor Necrosis Factor Inhibitors”, following treatment of RA with either of~~ the ~~TNF~~neuromuscular ~~inhibitors~~junction ~~Enbrel,~~causing ~~Humira or Remicade, mortality rates were on average approximately one death per 30 patients treated~~muscle inweakness ~~the first three years of treatment. Findings such as these~~ and ~~the long list of serious adverse events for all of the currently marketed treatments indicate that new and safer treatments for autoimmune diseases such as RA are needed~~fatigability.

~~Government~~Our ~~Regulation~~ long-term strategy contemplates the pursuit of FDA approval of PRTX-100 to treat other autoimmune and ~~Product~~inflammatory ~~Approval~~diseases in addition to RA and ITP.

The FDA and comparable regulatory agencies in state and local jurisdictions and in foreign countries impose substantial requirements upon the testing (preclinical and clinical), manufacturing, labeling, storage, recordkeeping, advertising, promotion, import, export, marketing and distribution, among other things, of drugs and drug product candidates. If we do not comply with applicable requirements, we may be fined, the government may refuse to approve our marketing applications or allow us to manufacture or market our products, and we may be criminally prosecuted. We and our manufacturers may also be subject to regulations under other U.S. federal, state, local and foreign laws.22

In the United States, the FDA regulates drugs under the Food Drug and Cosmetic Act, or FDCA, and implementing regulations. The process required by the FDA before our drug candidates may be marketed in the United States generally involves the following (although the FDA is given wide discretion to impose different or more stringent requirements on a case-by-case basis):Competition

·We ~~completion~~believe, based on the pre-clinical trials and the results to date of ~~extensive~~our ~~preclinical~~five ~~laboratory~~Phase ~~tests,~~I ~~preclinical~~RA ~~animal~~clinical studies, that PRTX-100 has a potential competitive advantage as it may be safer and ~~formulation~~more ~~studies~~efficacious than existing RA therapies, ~~all~~and ~~performed~~may cost less to manufacture than competing biologic-based therapies. Current RA treatments are characterized by complex manufacturing methods and, in ~~accordance~~2016, resulted in an average annual retail cost of approximately $13,000 to $30,000 per patient, if the newer disease-modifying anti-rheumatic drugs approved in the last 20 years were used. The cost can increase according to the size/weight of a patient and the number of doses required. Additionally, patients are faced with the ~~FDA’s~~cost ~~Good~~of ~~Laboratory~~the ~~Practice~~infusion oritself ~~GLP~~and ~~regulations~~blood tests which are often not included in those cost estimates. Several pharmaceutical agents are currently being used, with varying degrees of success, to control the signs and ~~other~~symptoms ~~regulations;~~of RA and slow its progression. Available treatment options include:

· ~~submission~~Analgesic/anti-inflammatory topreparations, ~~the~~ranging ~~FDA~~from ofsimple anaspirin ~~IND~~to ~~application~~the ~~which~~COX-2 ~~must become effective before clinical trials may begin~~inhibitors;

· ~~performance~~Immunosuppressive/antineoplastic ofdrugs, ~~multiple~~including ~~adequate~~azathioprine and ~~well-controlled clinical trials meeting FDA requirements to establish the safety and efficacy of the product candidate for each proposed indication~~methotrexate;

· ~~submission~~TNF of(Tumor aNecrosis ~~Biological~~Factor) ~~License~~inhibitors, ~~Application~~also orknown ~~BLA~~as toanti-TNF therapy, currently represented by etanercept (Enbrel®), infliximab (Remicade®), and adalimumab (Humira®) and the ~~FDA~~newer entries, certolizumab (Cimzia®) and golimumab (Simponi®);

· ~~satisfactory~~Soluble ~~completion~~Interleukin-l ~~of an FDA pre~~(IL-~~approval~~I) ~~inspection~~Receptor ~~of the manufacturing facilities at which the product candidate is produced~~Therapy, ~~and~~Anakinra ~~potentially~~(Kineret®) ~~other involved facilities as well, to assess compliance with cGMP, regulations~~ and ~~other~~(Il-6) ~~applicable~~tocilizumab ~~regulations~~(Actemra®); ~~and~~

· ~~the~~Costimulatory ~~FDA~~molecule ~~review~~inhibitor ~~and~~abatacept ~~approval of the BLA prior to any commercial marketing, sale or shipment of the drug.~~(Orencia®);

~~The~~· ~~testing~~Anti ~~and~~CD20 ~~approval~~B-cell-directed ~~process requires substantial time~~therapy, ~~effort~~rituximab ~~and~~(Rituxan®); ~~financial resources,~~ and we cannot be certain that any approvals for our drug candidates will be granted on a timely basis, if at all. Risks to us related to these regulations are described in the Risk Factors in Item 1A of this Annual Report.

A· ~~separate~~Janus ~~submission~~Kinase to(JAK) ~~the FDA~~inhibitor, ~~under an~~tofacitinib ~~existing~~citrate ~~IND must also be made for each successive clinical trial conducted during product development~~(Xeljanz). The FDA must also approve changes to an existing IND. Further, an independent institutional review board, or IRB, for each medical center proposing to conduct the clinical trial must review and approve the plan for any clinical trial before it commences at that center and it must monitor the study until completed. The FDA, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk. Clinical testing also must satisfy extensive Good Clinical Practice or GCP requirements and regulations for informed consent.

~~Clinical~~Many ~~Trials~~large and small pharmaceutical companies are active in this market, with Amgen Corporation (with Pfizer), Johnson & Johnson, Inc. (with Merck) and Abbott Laboratories dominating the market for biologic therapies with their respective products, Enbrel®, Remicade® and Humira®. According to each company’s 2016 annual report, Enbrel generated revenues of approximately $8.9 billion combined for Amgen and Pfizer, Remicade generated revenues of more than $8.2 billion combined for Johnson & Johnson and Merck, and AbbVie reported generated revenues of over $16 billion for Humira. For other TNF inhibitors, Cimzia generated revenues of $1.4 billion for UCB; Simponi generated revenues of $2.5 billion for Johnson & Johnson and Merck; and Orencia generated revenues of $2.3 billion for Bristol Myers Squibb. Kineret generated revenues of $114 million in sales for SOBI, which acquired from Amgen the rights to develop and commercialize Kineret in 2014. Actemra generated revenues of $1.7 billion for Roche. Also for Roche, Rituxan earned $1.5 billion for the treatment of RA alone, and billions more for other indications. Xeljanz nearly doubled its earnings for Pfizer from $523 million in 2015 to $927 million in 2016. Revenue figures above reflect the use of these drugs for RA, other indications and off label uses.

~~For~~Post–marketing ~~purposes~~experience has indicated that current and newly-marketed disease modifying anti-rheumatic drugs (DMARDs) subject patients to an increased risk of ~~BLA~~certain SAEs. Products ~~submission~~which inhibit the action of TNF-alpha, being the longest on the market and ~~approval~~the most studied, have demonstrated ~~clinical~~an ~~trials~~increased incidence of certain SAEs. Due to suppression of the immune system by these products, these SAEs include serious and opportunistic infections such as tuberculosis, fungal infections, and listeria infection, and increased risk of lymphomas. Transient neutropenia and other blood dyscrasias have been reported. TNF inhibitors are ~~typically~~also ~~conducted~~not recommended in patients with demyelinating disease or with congestive heart failure. Rituxan (anti-CD20) use increases the ~~following~~potential ~~three~~for ~~sequential~~Hep ~~phases~~B reactivation and multifocal leukoencephalopathy, ~~which~~a ~~may~~fatal ~~overlap~~viral disease. Kineret (~~although~~IL-1) ~~additional~~also orshows ~~different~~an increased the risk of infection. ~~trials~~Actemra ~~may~~(IL-6) beuse ~~required~~has led to increased liver enzyme levels, hypertension, transient neutropenia, and an increase in cholesterol levels. Orencia (T cell inhibition) also works by weakening the ~~FDA~~immune assystem, ~~well~~therefore can increase the risk of infections. Patients using Orencia have developed lymphoma and lung cancer. Xeljanz (JAK): is the newest RA treatment to enter the market. It has demonstrated similar side effects to TNF inhibitors, including invasive and opportunistic infections and the reactivation of tuberculosis. Lymphomas and other malignancies have been observed in patients treated with Xeljanz. In a study by a Swedish research group published in November 2012 by the American College of Rheumatology entitled, “Mortality Rates in Patients with Rheumatoid Arthritis Treated with Tumor Necrosis Factor Inhibitors”, following treatment of RA with either of the TNF inhibitors Enbrel, Humira or Remicade, mortality rates were on average approximately one death per 30 patients treated in the first three years of treatment. Findings such as these and the long list of serious adverse events for all of the currently marketed treatments indicate that new and safer treatments for autoimmune diseases such as RA are needed.

· Phase I clinical trials are initially conducted in a limited population to test the drug candidate for safety, dose tolerance, absorption, metabolism, distribution and excretion in healthy humans or, on occasion, in patients, such as cancer patients. In some cases, particularly in cancer trials, a sponsor may decide to conduct what is referred to as a “Phase 1b” evaluation, which is a second safety-focused Phase I clinical trial typically designed to evaluate the impact of the drug candidate in combination with currently FDA-approved drugs.23

·Government ~~Phase II clinical trials are generally conducted in a limited patient population to identify possible adverse effects~~ Regulation and ~~safety~~Product risks, to determine the efficacy of the drug candidate for specific targeted indications and to determine an optimal dosage. Multiple Phase II clinical trials may be conducted by the sponsor to obtain information prior to beginning larger and more expensive Phase III clinical trials. In some cases, a sponsor may decide to conduct what is referred to as a “Phase IIb” evaluation, which is a second, confirmatory Phase II clinical trial that could, if positive and accepted by the FDA, serve as a pivotal clinical trial in the approval of a drug candidate.Approval

21The FDA and comparable regulatory agencies in state and local jurisdictions and in foreign countries impose substantial requirements upon the testing (preclinical and clinical), manufacturing, labeling, storage, recordkeeping, advertising, promotion, import, export, marketing and distribution, among other things, of drugs and drug product candidates. If we do not comply with applicable requirements, we may be fined, the government may refuse to approve our marketing applications or allow us to manufacture or market our products, and we may be criminally prosecuted. We and our manufacturers may also be subject to regulations under other U.S. federal, state, local and foreign laws.

·In ~~Phase~~the ~~III~~United ~~clinical~~States, ~~trials~~the ~~are~~FDA ~~commonly~~regulates ~~referred~~drugs under tothe asFood ~~pivotal~~Drug ~~trials.~~and ~~When~~Cosmetic ~~Phase~~Act, IIor ~~clinical~~FDCA, ~~trials~~and ~~demonstrate~~implementing ~~that~~regulations. aThe ~~dose~~process ~~range~~required ofby the ~~drug~~FDA ~~candidate~~before isour ~~effective~~drug ~~and~~candidates may ~~has~~be anmarketed ~~acceptable safety profile, Phase III clinical trials are undertaken~~ in ~~large~~the ~~patient~~United ~~populations~~States togenerally ~~further~~involves ~~evaluate~~the ~~dosage,~~following to(although ~~provide~~the ~~substantial~~FDA ~~evidence~~is ofgiven ~~clinical~~wide ~~efficacy~~discretion ~~and~~ to ~~further~~impose ~~test~~different or ~~for~~more ~~safety~~stringent inrequirements anon ~~expanded~~a ~~and~~case-by-case ~~diverse patient population at multiple, geographically dispersed clinical trial sites.~~basis):

In· ~~some~~completion ~~cases,~~of ~~the~~extensive ~~FDA~~preclinical ~~may~~laboratory ~~condition~~tests, ~~continued approval~~preclinical ofanimal astudies ~~BLA~~and onformulation ~~the~~studies, ~~sponsor’s~~all ~~agreement~~performed toin ~~conduct~~accordance ~~additional clinical trials~~ with ~~due diligence. In other cases,~~ the ~~sponsor~~ ~~and the~~ FDA’s ~~may~~Good ~~agree~~Laboratory ~~that~~Practice ~~additional safety and/~~or ~~efficacy~~GLP ~~data~~regulations ~~should~~and beother ~~provided~~regulations; ~~however, continued approval of the BLA may not always depend on timely submission of such information. Such post-approval studies are typically referred to as Phase IV studies.~~

~~Biological~~· ~~License~~submission ~~Application~~to the FDA of an IND application which must become effective before clinical trials may begin;

~~The~~· ~~results~~performance of ~~drug~~multiple ~~candidate~~adequate ~~development, preclinical testing~~ and well-controlled clinical trials, ~~together~~meeting ~~with,~~FDA ~~among~~requirements ~~other~~to ~~things,~~establish ~~detailed information on~~ the ~~manufacture~~safety and ~~composition~~ efficacy of the product ~~and~~candidate ~~proposed labeling, and the payment of a user fee, are submitted to the FDA as part of a BLA. The FDA reviews all BLAs submitted before it accepts them~~ for ~~filing~~each ~~and~~proposed ~~may request additional information rather than accepting a BLA for filing. Once a BLA is accepted for filing, the FDA begins an in-depth review of the application.~~indication;

~~During~~· ~~its~~submission ~~review~~ of a ~~BLA,~~Biological ~~the~~License ~~FDA~~Application may refer the application to an advisory committee for review, evaluation and recommendation as to whether the application should be approved. The FDA may refuse to approve a BLA and issue a not approvable letter if the applicable regulatory criteria are not satisfied, or ~~it may require additional clinical or other data, including one or more additional pivotal Phase III clinical trials. Even if such data are submitted, the FDA may ultimately decide that the~~ BLA does not satisfy the criteria for approval. Data from clinical trials are not always conclusive and the FDA may interpret data differently than we or our collaboration partners interpret data. If the FDA’s evaluations of the BLA and the clinical and manufacturing procedures and facilities are favorable, the FDA may issue either an approval letter or an approvable letter, which contains the conditions that must be met in order to ~~secure final approval of~~ the ~~BLA.~~ ~~If and when those conditions have been met to the~~ FDA’s satisfaction, the FDA will issue an approval letter, authorizing commercial marketing of the drug for certain indications. The FDA may withdraw drug approval if ongoing regulatory requirements are not met or if safety problems occur after the drug reaches the market. In addition, the FDA may require testing, including Phase IV clinical trials, and surveillance programs to monitor the effect of approved products that have been commercialized, and the FDA has the power to prevent or limit further marketing of a drug based on the results of these post-marketing programs. Drugs may be marketed only for the FDA-approved indications and in accordance with the FDA-approved label. Further, if there are any modifications to the drug, including changes in indications, other labeling changes, or manufacturing processes or facilities, we may be required to submit and obtain FDA approval of a new BLA or BLA supplement, which may require us to develop additional data or conduct additional preclinical studies and clinical trials.;

~~Fast~~· ~~Track~~satisfactory ~~Designation~~completion of an FDA pre-approval inspection of the manufacturing facilities at which the product candidate is produced, and potentially other involved facilities as well, to assess compliance with cGMP, regulations and other applicable regulations; and

~~The~~· ~~FDA’s fast track program is intended to facilitate~~ the ~~development~~FDA ~~and to expedite the~~ review ~~of drugs that are intended for the treatment of a serious or life-threatening condition~~ and ~~that demonstrate the potential to address unmet medical needs. Under the fast track program, applicants may seek traditional~~ approval ~~for a product based on data demonstrating an effect on a clinically meaningful endpoint, or approval based on a well-established surrogate endpoint. The sponsor~~ of ~~a new drug candidate may request~~ the ~~FDA~~BLA ~~to designate the drug candidate for a specific indication as a fast track drug at the time of original submission of its IND, or at any time thereafter~~ prior to ~~receiving~~ ~~marketing~~any ~~approval~~commercial ~~of a~~ marketing, ~~application.~~sale ~~The~~or ~~FDA~~shipment ~~will determine if the drug candidate qualifies for fast track designation within 60 days~~ of ~~receipt of~~ the ~~sponsor’s request~~drug.

IfThe ~~the~~testing ~~FDA~~and ~~grants~~approval ~~fast~~process ~~track~~requires ~~designation,~~substantial ittime, ~~may~~effort ~~initiate review of sections of a BLA before the application is complete. This so-called “rolling review” is available if the applicant provides~~ and ~~the~~financial ~~FDA~~resources, ~~approves a schedule for the submission of the remaining information~~ and ~~the~~we ~~applicant has~~cannot ~~paid~~be ~~applicable~~certain ~~user~~that ~~fees.~~any ~~The~~approvals ~~FDA’s~~for ~~Prescription~~our ~~Drug~~drug ~~User~~candidates ~~Fee~~will ~~Act~~be orgranted ~~PDUFA~~on ~~review clock for both~~ a ~~standard and priority~~ ~~BLA~~timely ~~for a fast track product does not begin until the complete application is submitted. Additionally~~basis, ~~fast track designation may be withdrawn by the FDA~~ if itat ~~believes~~all. ~~that~~Risks ~~the~~to ~~designation~~us isrelated noto ~~longer~~these ~~supported~~regulations byare ~~emerging~~described ~~data,~~in ~~or if~~ the ~~designated~~Risk ~~drug development~~Factors ~~program~~in isItem no1A ~~longer~~of ~~being~~this ~~pursued~~Annual Report.

InA ~~some~~separate ~~cases,~~submission ato ~~fast~~the ~~track~~FDA, ~~designated~~under an ~~drug~~existing ~~candidate~~IND ~~may~~must also ~~qualify~~be made for ~~one~~each successive clinical trial conducted during product development. The FDA must also approve changes to an existing IND. Further, an independent institutional review board, or ~~more~~IRB, offor each medical center proposing to conduct the ~~following~~clinical ~~programs:~~trial must review and approve the plan for any clinical trial before it commences at that center and it must monitor the study until completed. The FDA, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk. Clinical testing also must satisfy extensive Good Clinical Practice or GCP requirements and regulations for informed consent.

·Clinical Priority Review. As explained above, a drug candidate may be eligible for a six-month priority review. The FDA assigns priority review status to an application if the drug candidate provides a significant improvement compared to marketed drugs in the treatment, diagnosis or prevention of a disease. A fast track drug would ordinarily meet the FDA’s criteria for priority review, but may also be assigned a standard review. We do not know whether any of our drug candidates will be assigned priority review status or, if priority review status is assigned, whether that review or approval will be faster than conventional FDA procedures, or that the FDA will ultimately approve the drug.Trials

22 For purposes of BLA submission and approval, clinical trials are typically conducted in the following three sequential phases, which may overlap (although additional or different trials may be required by the FDA as well):

· ~~Accelerated~~Phase ~~Approval.~~I ~~Under~~clinical ~~the~~trials ~~FDA’s~~are ~~accelerated~~initially ~~approval~~conducted ~~regulations,~~in ~~the~~a ~~FDA~~limited ispopulation ~~authorized~~ to ~~approve~~test the drug ~~candidates~~candidate ~~that have been studied~~ for ~~their~~ safety, ~~and~~dose ~~efficacy~~tolerance, inabsorption, ~~treating~~metabolism, ~~serious~~distribution ~~or life-threatening illnesses~~ and ~~that~~excretion ~~provide~~in ~~meaningful~~healthy ~~therapeutic~~humans ~~benefit to patients over existing treatments based upon either a surrogate endpoint that is reasonably likely to predict clinical benefit~~ or, on ~~the~~occasion, ~~basis~~in ofpatients, ansuch ~~effect~~as oncancer ~~a clinical endpoint other than patient survival or irreversible morbidity~~patients. In ~~clinical~~some ~~trials~~cases, ~~surrogate~~particularly ~~endpoints~~in ~~are~~cancer ~~alternative~~trials, ~~measurements of the symptoms of~~ a ~~disease~~sponsor ormay ~~condition~~decide ~~that~~to ~~are~~conduct ~~substituted~~what ~~for measurements of observable clinical symptoms. A drug candidate approved on this basis~~ is ~~subject~~referred to ~~rigorous~~as ~~post-marketing~~a ~~compliance requirements, including the completion of~~ “Phase IV1b” ~~or post-approval clinical trials to validate the surrogate endpoint or confirm the effect on the clinical endpoint. Failure to conduct required post-approval studies with due diligence~~evaluation, orwhich tois ~~validate~~ a ~~surrogate~~second ~~endpoint~~safety-focused orPhase ~~confirm~~I a clinical ~~benefit~~trial ~~during~~typically ~~post-marketing~~designed ~~studies, may cause the FDA~~ to ~~seek~~evaluate ~~to withdraw~~ the ~~drug~~impact ~~from~~of the ~~market on an expedited basis. All promotional materials for~~ drug ~~candidates~~candidate ~~approved~~in ~~under~~combination ~~accelerated~~with ~~regulations~~currently ~~are subject to prior review by the~~ FDA-approved drugs.

~~When~~· ~~appropriate,~~Phase weII ~~intend~~clinical trials are generally conducted in a limited patient population to ~~seek~~identify ~~fast track~~possible ~~designation~~adverse effects and safety risks, ~~accelerated~~to ~~approval~~determine orthe ~~priority~~efficacy ~~review~~of the drug candidate for ~~our~~specific ~~drug~~targeted ~~candidates~~indications and to determine an optimal dosage. WeMultiple ~~cannot~~Phase ~~predict~~II ~~whether~~clinical ~~any~~trials ofmay ~~our~~be ~~drug~~conducted ~~candidates will~~by the sponsor to obtain ~~fast~~information ~~track,~~prior ~~accelerated~~to ~~approval,~~beginning orlarger ~~priority~~and ~~review~~more ~~designation~~expensive Phase III clinical trials. In some cases, ora ~~the~~sponsor ~~ultimate~~may ~~impact~~decide to conduct what is referred to as a “Phase IIb” evaluation, ifwhich ~~any~~is a second, ofconfirmatory ~~these~~Phase ~~expedited review~~II ~~mechanisms~~clinical ontrial ~~the~~that ~~timing~~could, orif ~~likelihood~~positive ofand accepted by the FDA, ~~approval~~serve ofas ~~any~~a pivotal clinical trial in the approval of ~~our~~a drug ~~candidates~~candidate.

Satisfaction of the FDA regulations and approval requirements or similar requirements of foreign regulatory agencies typically takes several years, and the actual time required may vary substantially based upon the type, complexity and novelty of the product or disease. Typically, if a drug candidate is intended to treat a chronic disease, as is the case with the drug candidate we are developing, safety and efficacy data must be gathered over an extended period of time. Government regulation may delay or prevent marketing of drug candidates for a considerable period of time and impose costly procedures upon our activities. The FDA or any other regulatory agency may not grant approvals for changes in dosage form or new indications for our drug candidates on a timely basis, or at all. Even if a drug candidate receives regulatory approval, the approval may be significantly limited to specific disease states, patient populations and dosages. Further, even after regulatory approval is obtained, later discovery of previously unknown problems with a drug may result in restrictions on the drug or even complete withdrawal of the drug from the market. Delays in obtaining, or failures to obtain, regulatory approvals for our drug candidate would harm our business. In addition, we cannot predict what adverse governmental regulations may arise from future U.S. or foreign governmental action.24

~~Regulatory~~· ~~Requirements~~Phase III clinical trials are commonly referred to as pivotal trials. When Phase II clinical trials demonstrate that a dose range of the drug candidate is effective and has an acceptable safety profile, Phase III clinical trials are undertaken in large patient populations to further evaluate dosage, to provide substantial evidence of clinical efficacy and to further test for safety in an expanded and diverse patient population at multiple, geographically dispersed clinical trial sites.

~~Any~~In ~~drugs~~some ~~manufactured~~cases, ~~or distributed by us or any potential collaboration partners pursuant to future FDA approvals are subject to continuing regulation by~~ the FDA, ~~including~~may ~~recordkeeping requirements~~condition ~~and~~continued ~~reporting~~approval of ~~adverse~~a ~~experiences associated with the drug. Drug manufacturers and their subcontractors are required~~BLA toon ~~register with~~ the ~~FDA~~sponsor’s ~~and~~agreement ~~certain state agencies, and are subject~~ to ~~periodic~~conduct ~~unannounced~~additional ~~inspections~~clinical bytrials ~~the FDA and certain state agencies for compliance~~ with ~~ongoing~~due ~~regulatory~~diligence. ~~requirements,~~In ~~including~~other ~~cGMP~~cases, ~~which~~the ~~impose~~sponsor ~~certain procedural~~ and ~~documentation~~the ~~requirements~~FDA ~~upon~~may usagree ~~and~~that ~~our~~additional ~~third-party~~safety ~~manufacturers. Failure to comply with the statutory~~ and ~~regulatory requirements can subject a manufacturer to possible legal~~ /or ~~regulatory~~efficacy ~~action,~~data ~~such~~should asbe ~~warning~~provided; ~~letters~~however, ~~suspension~~continued ofapproval ~~manufacturing, sales or use, seizure~~ of ~~product,~~the ~~injunctive~~BLA ~~action~~may ornot ~~possible civil penalties. We cannot be certain that we or our present or future third-party manufacturers~~always ordepend ~~suppliers~~on ~~will~~timely besubmission ~~able~~of tosuch ~~comply with the cGMP regulations and other ongoing FDA regulatory requirements~~information. IfSuch ~~our present or future third~~post-~~party~~approval ~~manufacturers~~studies ~~or suppliers~~ are ~~not~~typically ~~able~~referred to ~~comply~~as ~~with~~Phase IV ~~these requirements, the FDA may halt our clinical trials, require us to recall a drug from distribution, or withdraw approval of the BLA for that drug~~studies.

~~The~~Biological ~~FDA~~License closely regulates the post-approval marketing and promotion of drugs, including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities and promotional activities involving the Internet. A company can make only those claims relating to safety and efficacy that are approved by the FDA. Failure to comply with these requirements can result in adverse publicity, warning and/or untitled letters, corrective advertising and potential civil and criminal penalties.Application

~~Orphan~~The ~~Drug~~results ~~Designation~~of indrug candidate development, preclinical testing and clinical trials, together with, among other things, detailed information on the ~~United~~manufacture ~~States~~and composition of the product and proposed labeling, and the ~~European~~payment of a user fee, are submitted to the FDA as part of a BLA. The FDA reviews ~~Union~~all BLAs submitted before it accepts them for filing and ~~other~~may ~~foreign~~request ~~jurisdictions~~additional information rather than accepting a BLA for filing. Once a BLA is accepted for filing, the FDA begins an in-depth review of the application.

InDuring ~~June~~its ~~2015~~review of a BLA, the FDA ~~granted~~may ~~Orphan~~refer ~~Drug~~the application to ~~Designation~~an advisory committee for review, evaluation and recommendation as to ~~PRTX-100~~whether inthe application should be approved. The FDA may refuse to approve a BLA and issue a not approvable letter if the ~~treatment~~applicable ~~for~~regulatory ~~ITP~~criteria are not satisfied, or it may require additional clinical or other data, including one or more additional pivotal Phase III clinical trials. InEven ~~September~~if ~~2015~~such data are submitted, the ~~COMP~~FDA ~~issued~~may aultimately ~~positive~~decide ~~opinion~~that ~~recommending~~the ~~PRTX-100~~BLA does not satisfy the criteria for ~~designation~~approval. Data from clinical trials are not always asconclusive and the FDA may interpret data differently than we or our collaboration partners interpret data. If the FDA’s evaluations of the BLA and the clinical and manufacturing procedures and facilities are favorable, the FDA may issue either an approval ~~orphan~~letter ~~medicinal~~or ~~product~~an ~~for~~approvable ~~ITP~~letter, which contains the conditions that must be met in order to secure final approval of the BLA. ~~Based~~If ~~upon~~and ~~study~~when ~~data~~those conditions have been met to ~~date~~the FDA’s satisfaction, wethe ~~believe~~FDA will issue an approval letter, authorizing commercial marketing of the drug for certain indications. The FDA may withdraw drug approval if ongoing regulatory requirements are not met or if safety problems occur after the drug reaches the market. In addition, the FDA may require testing, including Phase IV clinical trials, and surveillance programs to monitor the effect of approved products that ~~PRTX~~have been commercialized, and the FDA has the power to prevent or limit further marketing of a drug based on the results of these post-~~100~~marketing programs. Drugs may be ~~effective~~marketed only for the FDA-approved indications and in accordance with the ~~treatment~~FDA-approved label. Further, if there are ofany ~~ITP~~modifications to the drug, asincluding ~~well~~changes asin indications, other ~~orphan~~labeling ~~immunological~~changes, ~~diseases~~or manufacturing processes or facilities, we may be required to submit and obtain FDA approval of a new BLA or BLA supplement, which may require us to develop additional data or conduct additional preclinical studies and clinical trials.

~~Under~~Fast ~~the~~Track ~~U.S. Orphan Drug Act, Orphan Drug~~ Designation is granted by the FDA to drugs intended to treat a rare disease or condition, which for this program is defined as having a prevalence of fewer than 200,000 individuals in the United States. Orphan Drug Designation must be requested before submitting a marketing application. After the FDA grants an Orphan Drug Designation, the generic identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA.

~~Orphan~~The ~~Drug~~FDA’s ~~Designation~~fast ~~does~~track ~~not~~program ~~shorten~~is intended ~~the~~to ~~regulatory~~facilitate ~~review~~the development and ~~approval~~to ~~process,~~expedite ~~nor~~the ~~does~~review itof ~~provide~~drugs ~~any~~that ~~advantage~~are inintended for the ~~regulatory~~treatment ~~review~~of a serious or life-threatening condition and ~~approval~~that ~~process~~demonstrate the potential to address unmet medical needs. ~~However~~Under the fast track program, applicants may seek iftraditional approval for a product ~~which~~based ~~has~~on andata ~~Orphan~~demonstrating ~~Drug~~an ~~Designation~~effect ~~subsequently~~on ~~receives~~a ~~the~~clinically ~~first~~meaningful ~~FDA~~endpoint, or approval ~~for~~based on ~~the~~a ~~indication~~well-established ~~for~~surrogate ~~which~~endpoint. The ~~it has~~sponsor ~~such~~of ~~designation,~~a ~~the~~new ~~product~~drug iscandidate ~~entitled~~may request the FDA to andesignate ~~orphan~~the ~~exclusivity~~drug ~~period,~~candidate for ina ~~which~~specific indication as a fast track drug at the ~~FDA~~time ~~may~~of ~~not~~original ~~approve~~submission of its IND, or at any ~~other~~time ~~applications~~ thereafter prior to receiving ~~market~~marketing ~~the~~approval ~~same~~of ~~drug~~a ~~for~~marketing application. The FDA will determine if the ~~same~~drug ~~indication~~candidate qualifies for ~~seven~~fast ~~years~~track designation inwithin ~~the~~60 days ~~United~~of ~~States,~~receipt ~~except~~of inthe ~~limited~~sponsor’s ~~circumstances~~request.

23 If the FDA grants fast track designation, it may initiate review of sections of a BLA before the application is complete. This so-called “rolling review” is available if the applicant provides and the FDA approves a schedule for the submission of the remaining information and the applicant has paid applicable user fees. The FDA’s Prescription Drug User Fee Act or PDUFA review clock for both a standard and priority BLA for a fast track product does not begin until the complete application is submitted. Additionally, fast track designation may be withdrawn by the FDA if it believes that the designation is no longer supported by emerging data, or if the designated drug development program is no longer being pursued.

In addition, outside of the U.S. medicinal products used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in European Union and medicinal products which, for economic reasons, would be unlikely to be developed without incentives may be granted orphan designation in the European Union. The application for orphan designation is submitted to the EMA before an application is made for marketing authorization. Once authorized, orphan medicinal products are entitled to ten years of market exclusivity. During this ten-year period, with a limited number of exceptions, neither the competent authorities of the European Union member states nor the EMA are permitted to accept applications or grant marketing authorization for other similar medicinal products with the same orphan indication. However, marketing authorization may be granted to a similar medicinal product with the same orphan indication during the ten-year period with the consent of the marketing authorization holder for the original orphan medicinal product or if the manufacturer of the original orphan medicinal product is unable to supply sufficient quantities. Marketing authorization may also be granted to a similar medicinal product with the same orphan indication if this product is safer, more effective or otherwise clinically superior to the original orphan medicinal product.25

WeIn ~~retained~~some ~~the consulting services of Coté Orphan Consulting~~cases, ~~LLC (Coté) to submit the application for Orphan Drug Designation in the EU for PRTX-100 as Protalex, Inc. does not maintain~~ a ~~European~~fast ~~subsidiary.~~track Ondesignated ~~October 9, 2015, PRTX-100 was granted Orphan Drug Designation in EU~~drug ascandidate ~~EU/3/15/1562~~may ~~(EMA/OD/111/15)~~also qualify for ~~the~~one ~~treatment~~or ofmore ~~Immune Thrombocytopenia. Coté Orphan Consulting UK Limited, a subsidiary~~ of ~~Coté Orphan Consulting, LLC, is identified as~~ the ~~sponsor~~following ~~of the designation for PRTX-100 in the EU. Under our agreement with Coté, we retain all ownership in the Orphan Drug Designation for PRTX-100 in the EU.~~programs:

In· ~~August~~Priority ~~2017~~Review. As explained above, a drug candidate may be eligible for a six-month priority review. The FDA assigns priority review status to an application if the ~~OOPD~~drug ~~awarded~~candidate usprovides a ~~grant of~~significant ~~$403,000~~improvement compared to ~~support~~marketed drugs in the ~~future~~treatment, ~~clinical~~diagnosis ~~development~~or prevention of ~~PRTX-100~~a asdisease. aA ~~treatment~~fast track drug would ordinarily meet the FDA’s criteria for ~~ITP~~priority review, but may also be assigned a standard review. We do not know whether any of our drug candidates will be assigned priority review status or, if priority review status is assigned, whether that review or approval will be faster than conventional FDA procedures, or that the FDA will ultimately approve the drug.

~~Foreign~~· ~~Regulation~~Accelerated Approval. Under the FDA’s accelerated approval regulations, the FDA is authorized to approve drug candidates that have been studied for their safety and efficacy in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments based upon either a surrogate endpoint that is reasonably likely to predict clinical benefit or on the basis of an effect on a clinical endpoint other than patient survival or irreversible morbidity. In clinical trials, surrogate endpoints are alternative measurements of the symptoms of a disease or condition that are substituted for measurements of observable clinical symptoms. A drug candidate approved on this basis is subject to rigorous post-marketing compliance requirements, including the completion of Phase IV or post-approval clinical trials to validate the surrogate endpoint or confirm the effect on the clinical endpoint. Failure to conduct required post-approval studies with due diligence, or to validate a surrogate endpoint or confirm a clinical benefit during post-marketing studies, may cause the FDA to seek to withdraw the drug from the market on an expedited basis. All promotional materials for drug candidates approved under accelerated regulations are subject to prior review by the FDA.

InWhen ~~addition~~appropriate, towe ~~regulations~~intend into ~~the~~seek ~~United~~fast ~~States~~track designation, weaccelerated ~~will~~approval ~~be subject~~or topriority areview ~~variety~~for ofour ~~foreign~~drug ~~regulations~~candidates. ~~governing~~We ~~clinical~~cannot ~~trials~~predict ~~and~~whether ~~commercial~~any ~~sales and distribution~~ of our ~~future~~drug ~~products.~~candidates ~~Whether~~will ~~or not we~~ obtain ~~FDA~~fast ~~approval for a product~~track, weaccelerated ~~must obtain~~ approval, ofor apriority ~~product~~review bydesignation, ~~the comparable regulatory authorities of foreign countries before we can commence clinical trials~~ or ~~marketing of~~ the ~~product~~ultimate inimpact, ~~those~~if ~~countries.~~any, ~~The~~of ~~approval~~these ~~process~~expedited ~~varies~~review ~~from~~mechanisms ~~country~~on ~~to country, and~~ the ~~time~~timing ~~may be longer~~ or ~~shorter~~likelihood ~~than~~of ~~that~~the ~~required for~~ FDA approval. ~~The~~of ~~requirements~~any ~~governing the conduct~~ of ~~clinical~~our ~~trials,~~drug ~~product licensing, pricing and reimbursement vary greatly from country to country~~candidates.

~~Under~~Satisfaction ~~European~~of ~~Union~~the FDA regulations and approval requirements or similar requirements of foreign regulatory ~~systems~~agencies typically takes several years, ~~marketing~~ ~~authorizations~~and the actual time required may bevary ~~submitted~~substantially based ~~either~~upon ~~under~~the atype, ~~centralized~~complexity orand ~~mutual~~novelty ~~recognition~~of ~~procedure~~the product or disease. ~~The~~Typically, ~~centralized~~if ~~procedure~~a drug candidate is intended to treat a chronic ~~provides~~disease, ~~for~~as is the ~~grant~~case with the drug candidate we are developing, safety and efficacy data must be gathered over an extended period of atime. ~~single~~Government ~~marketing~~regulation ~~authorization~~may ~~that~~delay isor ~~valid~~prevent marketing of drug candidates for ~~all~~a ~~European~~considerable ~~Union~~period ~~member~~of ~~states~~time and impose costly procedures upon our activities. The ~~mutual~~FDA ~~recognition procedure~~or ~~provides~~any other regulatory agency may not grant approvals for ~~mutual~~changes ~~recognition~~in ofdosage ~~national~~form ~~approval~~or ~~decisions.~~new indications ~~Under~~for ~~this~~our ~~procedure~~drug candidates on a timely basis, ~~the~~or ~~holder~~at ofall. Even if a ~~national~~drug ~~marketing authorization~~candidate receives regulatory approval, the approval may ~~submit~~be ansignificantly ~~application~~limited to ~~the~~specific ~~remaining~~disease ~~member~~ states, patient populations and dosages. ~~Within~~Further, ~~90 days~~even after regulatory approval is obtained, later discovery of ~~receiving~~previously unknown problems with a drug may result in restrictions on the ~~applications~~drug ~~and~~or ~~assessment~~even complete ~~report,~~withdrawal ~~each~~of ~~member~~the ~~state~~drug ~~must~~from ~~decide~~the ~~whether~~market. Delays in obtaining, or failures to ~~recognize~~obtain, ~~approval~~regulatory approvals for our drug candidate would harm our business. In addition, we cannot predict what adverse governmental regulations may arise from future U.S. or foreign governmental action.

InRegulatory ~~addition to regulations in Europe and the United States, we will be subject to a variety of foreign regulations governing clinical trials and commercial distribution of our future products.~~Requirements

~~Patents~~Any drugs manufactured or distributed by us or any potential collaboration partners pursuant to future FDA approvals are subject to continuing regulation by the FDA, ~~Trademarks~~including recordkeeping requirements and reporting of adverse experiences associated with the drug. Drug manufacturers and their subcontractors are required to register with the FDA and certain state agencies, and ~~Proprietary~~are ~~Technology~~subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with ongoing regulatory requirements, including cGMP, which impose certain procedural and documentation requirements upon us and our third-party manufacturers. Failure to comply with the statutory and regulatory requirements can subject a manufacturer to possible legal or regulatory action, such as warning letters, suspension of manufacturing, sales or use, seizure of product, injunctive action or possible civil penalties. We cannot be certain that we or our present or future third-party manufacturers or suppliers will be able to comply with the cGMP regulations and other ongoing FDA regulatory requirements. If our present or future third-party manufacturers or suppliers are not able to comply with these requirements, the FDA may halt our clinical trials, require us to recall a drug from distribution, or withdraw approval of the BLA for that drug.

Patents and other proprietary rights are important to our business. Our practice is to file patent applications to protect technology, inventions and improvements to our technologies that are considered important to the development of our business. We have filed several U.S. patent applications and international counterparts of certain of these applications. We also rely upon our trade secrets, know-how, and continuing technological innovations, as well as patents that we may license from other parties, to develop and maintain our competitive position.26

~~Our~~The ~~success~~FDA ~~will~~closely ~~depend~~regulates onthe ~~our~~post-approval ~~ability~~marketing and promotion of drugs, including standards and regulations for direct-to-consumer ~~maintain~~advertising, ~~our~~off-label ~~trade~~promotion, ~~secrets~~industry-sponsored scientific and ~~proprietary~~educational ~~technology~~activities inand promotional activities involving the ~~United~~Internet. ~~States~~A company can make only those claims relating to safety and efficacy that are approved by the FDA. Failure to comply with these requirements can result in ~~other~~adverse ~~countries~~publicity, warning and/or untitled letters, corrective advertising and potential civil and criminal penalties.

24 Orphan Drug Designation in the United States, the European Union and other foreign jurisdictions

~~The~~In ~~table~~June ~~below~~2015, ~~provides~~the aFDA ~~list~~granted ofOrphan ~~our~~Drug Designation to PRTX-100 in the treatment for ITP. In September 2015, COMP issued ~~patents:~~a positive opinion recommending PRTX-100 for designation as an orphan medicinal product for ITP. Based upon study data to date, we believe that PRTX-100 may be effective in the treatment of ITP, as well as other orphan immunological diseases.

Patent Title	Number	Expiration Date
Protein A Compositions and Methods of Use	U.S. Patent No. 7,211,258	Nov. 6, 2022
Protein A Methods of Use	U.S. Patent No. 7,425,331	Nov. 6, 2022
Protein A Compositions and Methods of Use	U.S. Patent No. 7,807,170	April 10, 2022
Protein A Compositions and Methods of Use	U.S. Patent No. 8,168,189	June 16, 2022
Protein A Compositions and Methods of Use	U.S. Patent No. 8,603,486	April 10, 2022
Protein A Compositions and Methods of Use	European Patent No. 2570136	March 6, 2023
Protein A Composition and Method of Use	Japanese Patent No. 5523796	March 6, 2023
Protein A Compositions and Methods of Use	U.S. Patent No. 9,370,552	November 6, 2022
Protein A Compositions and Methods of Use	European Patent No. 2,206,511	September 13, 2025
Protein A Compositions and Methods of Use	Canadian Patent No. 2,894,098	March 6, 2023
Protein A Compositions and Methods of Use	Canadian Patent No. 2,481,282	March 6, 2023
Protein A Compositions and Methods of Use	European Patent No. 1,499,345	March 6, 2023

Under the U.S. Orphan Drug Act, Orphan Drug Designation is granted by the FDA to drugs intended to treat a rare disease or condition, which for this program is defined as having a prevalence of fewer than 200,000 individuals in the United States. Orphan Drug Designation must be requested before submitting a marketing application. After the FDA grants an Orphan Drug Designation, the generic identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA.

WeOrphan ~~also~~Drug ~~have~~Designation adoes ~~patent~~not ~~application~~shorten ~~pending~~the inregulatory ~~Hong~~review ~~Kong.~~and Itapproval isprocess, ~~our~~nor ~~policy~~does toit ~~require~~provide ~~our~~any ~~employees,~~advantage ~~consultants,~~in the regulatory review and ~~parties~~approval toprocess. ~~collaborative~~However, if ~~agreements~~a toproduct ~~execute~~which ~~confidentiality agreements~~has ~~upon~~an ~~the~~Orphan ~~commencement~~Drug ofDesignation ~~employment~~subsequently orreceives ~~consulting~~the ~~relationships~~first orFDA ~~collaborations~~approval ~~with~~for ~~us.~~the ~~These~~indication ~~agreements~~for ~~generally~~which it ~~provide~~has ~~that~~such ~~all~~designation, ~~confidential~~the ~~information~~product ~~developed~~is orentitled ~~made~~to ~~known~~an ~~during~~orphan ~~the~~exclusivity ~~course~~period, ofin which the ~~relationship~~FDA ~~with~~may usnot isapprove any other applications to bemarket ~~kept~~the ~~confidential and~~same ~~not~~drug tofor bethe ~~disclosed~~same toindication ~~third~~for ~~parties~~seven years in the United States, except in ~~specific~~limited circumstances.

~~Employees~~In addition, outside of the U.S. medicinal products used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in European Union and medicinal products which, for economic reasons, would be unlikely to be developed without incentives may be granted orphan designation in the European Union. The application for orphan designation is submitted to the EMA before an application is made for marketing authorization. Once authorized, orphan medicinal products are entitled to ten years of market exclusivity. During this ten-year period, with a limited number of exceptions, neither the competent authorities of the European Union member states nor the EMA are permitted to accept applications or grant marketing authorization for other similar medicinal products with the same orphan indication. However, marketing authorization may be granted to a similar medicinal product with the same orphan indication during the ten-year period with the consent of the marketing authorization holder for the original orphan medicinal product or if the manufacturer of the original orphan medicinal product is unable to supply sufficient quantities. Marketing authorization may also be granted to a similar medicinal product with the same orphan indication if this product is safer, more effective or otherwise clinically superior to the original orphan medicinal product.

We ~~have~~retained ~~two~~the ~~employees,~~consulting ~~our~~services ~~president~~of ~~and~~Coté ~~our~~Orphan ~~chief~~Consulting, ~~financial~~LLC ~~officer~~(Coté) to submit the application for Orphan Drug Designation in the EU for PRTX-100 as Protalex, Inc. Wedoes ~~also~~not ~~have~~maintain a ~~Scientific~~European ~~Advisory~~subsidiary. ~~Board~~On ~~which~~October is9, ~~staffed~~2015, byPRTX-100 ~~highly~~was ~~qualified~~granted ~~consultants~~Orphan ~~with~~Drug Designation in EU as EU/3/15/1562 (EMA/OD/111/15) for the treatment of Immune Thrombocytopenia. Coté Orphan Consulting UK Limited, a subsidiary of Coté ~~background~~Orphan ~~and~~Consulting, ~~scientific~~LLC, ~~expertise~~is weidentified ~~need~~as tothe ~~carry~~sponsor ~~out~~of ~~our~~the ~~long-term~~designation ~~business~~for ~~objectives.~~PRTX-100 Wein ~~believe~~the ~~that~~EU. Under our ~~relationship~~agreement with Coté, we retain all ofownership ~~our~~in ~~employees~~the ~~and~~Orphan ~~our~~Drug ~~Scientific~~Designation ~~Advisory~~for ~~Board~~PRTX-100 isin ~~generally~~the ~~good~~EU.

~~Critical~~In ~~Accounting~~August ~~Policies~~2017, the OOPD awarded us a grant of $403,000 to support the future clinical development of PRTX-100 as a treatment for ITP.

~~Our~~Foreign financial statements are prepared in conformity with accounting principles generally accepted in the United States of America. Note 3 to the financial statements describes the significant accounting policies and methods used in the preparation of our financial statements.Regulation

WeIn ~~have~~addition ~~identified~~to ~~the~~regulations ~~policies~~in ~~below~~the ~~as some~~United ofStates, ~~the~~we ~~more~~will ~~critical~~be subject to ~~our~~a ~~business~~variety ~~and~~of ~~the~~foreign ~~understanding~~regulations ofgoverning ~~our~~clinical ~~financial~~trials ~~position~~and commercial sales and ~~results~~distribution of ~~operations. These policies~~our ~~may~~future ~~involve~~products. aWhether or ~~high~~not ~~degree~~we ofobtain ~~judgment~~FDA ~~and~~approval ~~complexity~~for ina ~~their~~product, ~~application~~we ~~and~~must ~~represent~~obtain ~~the~~approval ~~critical~~of ~~accounting~~a ~~policies used~~product inby the ~~preparation~~comparable ofregulatory ~~our~~authorities ~~financial~~of ~~statements.~~foreign countries ~~Although~~before we ~~believe~~can ~~our~~commence ~~judgments~~clinical ~~and~~trials ~~estimates~~or ~~are~~marketing ~~appropriate~~of ~~and~~the ~~correct, actual~~product ~~future~~in ~~results~~those ~~may differ from estimates~~countries. IfThe ~~different~~approval ~~assumptions~~process orvaries ~~conditions~~from country ~~were~~ to ~~prevail~~country, and the ~~results~~time ~~could~~may be ~~materially different~~longer ~~from~~or ~~these~~shorter ~~reported~~than ~~results.~~that ~~The~~required ~~impact~~for ~~and~~FDA ~~any~~approval. ~~associated~~The ~~risks~~requirements ~~related~~governing tothe ~~these policies on our business operations~~conduct ~~are~~of ~~discussed~~clinical ~~throughout~~trials, ~~this~~product ~~Report~~licensing, ~~where~~pricing ~~such~~and ~~policies~~reimbursement ~~affect~~vary ~~our~~greatly ~~reported~~from ~~and~~country ~~expected~~to ~~financial results~~country.

25 27

~~The~~Under ~~preparation~~European ofUnion ~~our~~regulatory ~~financial statements~~systems, marketing inauthorizations ~~conformity~~may ~~with~~be ~~accounting~~submitted ~~principles~~either ~~generally~~under ~~accepted~~a incentralized ~~the~~or ~~United~~mutual ~~States,~~recognition ~~requires~~procedure. ~~management~~The tocentralized ~~make~~procedure ~~estimates and assumptions~~provides ~~that~~for ~~affect~~ the ~~reported~~grant ~~amounts~~ of ~~assets,~~a ~~liabilities~~single ~~and~~marketing ~~equity~~authorization ~~and~~that ~~disclosure~~is ofvalid ~~contingent~~for ~~assets~~all ~~and~~European ~~liabilities~~Union atmember ~~the~~states. ~~date~~The mutual recognition procedure provides for mutual recognition of ~~the~~national ~~financial~~approval ~~statements~~decisions. ~~and~~Under ~~the~~this ~~reported~~procedure, ~~amounts~~the holder of ~~expenses~~a ~~during~~national marketing authorization may submit an application to the ~~reporting~~remaining ~~period~~member states. ~~These~~Within ~~estimates~~90 days ~~have~~of areceiving ~~material~~the ~~impact on~~applications ~~our~~and ~~financial~~assessment ~~statements~~report, each ~~and~~member ~~are~~state ~~discussed~~must indecide ~~detail~~whether ~~throughout~~to ~~this~~recognize ~~Report~~approval.

AsIn ~~part~~addition ~~of the process of preparing our financial statements, we are required~~ to ~~estimate~~regulations ~~income taxes~~ in ~~each~~Europe ~~of the jurisdictions in which we operate. This process involves estimating actual current tax expense together with assessing temporary differences resulting from differing treatment of items for tax~~ and ~~accounting purposes. These differences result in deferred tax assets and liabilities, which are included within~~ the ~~balance~~ ~~sheet.~~United ~~We must then assess the likelihood that our deferred tax assets will be recovered from future taxable income and to the extent we believe that recovery is not likely~~States, we ~~must establish a valuation allowance. In the event that we determine that~~will ~~we would~~ be ~~able~~subject to ~~realize~~a ~~deferred~~variety ~~tax assets in the future in excess~~ of ~~the~~foreign ~~net~~regulations ~~recorded~~governing ~~amount,~~clinical antrials ~~adjustment~~and tocommercial ~~the~~distribution ~~deferred tax~~of ~~asset~~our ~~valuation~~future ~~allowance would increase income in the period such determination was made~~products.

WePatents, account for our stock option grants under the provisions of the accounting guidance for Share-Based Payments. Such guidance requires the recognition of the fair value of share-based compensation in the statements of operations. The fair value of our stock option awards was estimated using a Black-Scholes option valuation model. This model requires the input of highly subjective assumptions and elections in adopting and implementing this guidanceTrademarks, ~~including expected stock price volatility~~ and ~~the~~Proprietary estimated life of each award. The fair value of share-based awards is amortized over the vesting period of the award and we have elected to use the straight-line method for awards granted after the adoption of this guidance.Technology

~~Results~~Patents and other proprietary rights are important to our business. Our practice is to file patent applications to protect technology, inventions and improvements to our technologies that are considered important to the development of ~~Operations~~our business. We have filed several U.S. patent applications and international counterparts of certain of these applications. We also rely upon our trade secrets, know-how, and continuing technological innovations, as well as patents that we may license from other parties, to develop and maintain our competitive position.

~~For~~Our ~~the~~success ~~Three~~will ~~Months~~depend ~~Ended~~on ~~August~~our ~~31,~~ability ~~2017~~to maintain our trade secrets and ~~August~~proprietary ~~31, 2016~~technology in the United States and in other countries.

~~Research and Development Expenses - Research and Development expenses (“R&D Expenses”) were $681,829 and $448,981 for the three months ended August 31, 2017 and August 31, 2016, respectively.~~ The ~~increase~~table inbelow ~~R&D~~provides ~~expenses~~a ~~for~~list ~~the three month period ended August 31, 2017 compared to the same prior year period was due to an increase in clinical activities associated with the ITP study and an increase in production~~ of ~~drug~~our ~~material and drug product.~~issued patents:

There are significant risks and uncertainties inherent in the preclinical and clinical studies associated with our research and development program. These studies may yield varying results that could delay, limit or prevent a program’s advancement through the various stages of product development and significantly impact the costs to be incurred, and time involved, in bringing a program to completion. As a result, the costs to complete such programs, as well as the period in which net cash outflows from such programs are expected to be incurred, are not reasonably estimable.

Patent Title	Number	Expiration Date

Protein A Compositions and Methods of Use	U.S. Patent No. 7,211,258	Nov. 6, 2022

Protein A Methods of Use	U.S. Patent No. 7,425,331	Nov. 6, 2022

Protein A Compositions and Methods of Use	U.S. Patent No. 7,807,170	April 10, 2022

Protein A Compositions and Methods of Use	U.S. Patent No. 8,168,189	June 16, 2022

Protein A Compositions and Methods of Use	U.S. Patent No. 8,603,486	April 10, 2022

Protein A Compositions and Methods of Use	European Patent No. 2570136	March 6, 2023

Protein A Composition and Method of Use	Japanese Patent No. 5523796	March 6, 2023

Protein A Compositions and Methods of Use	U.S. Patent No. 9,370,552	November 6, 2022

Protein A Compositions and Methods of Use	European Patent No. 2,206,511	September 13, 2025

Protein A Compositions and Methods of Use	Canadian Patent No. 2,894,098	March 6, 2023

Protein A Compositions and Methods of Use	Canadian Patent No. 2,481,282	March 6, 2023

Protein A Compositions and Methods of Use	European Patent No. 1,499,345	March 6, 2023

Protein A Compositions and Methods of Use	Hong Kong Patent No. 1145805B	September 13, 2025

~~Administrative~~It ~~Expenses~~is -our ~~Administrative expenses~~policy ~~were~~to ~~$142~~require our employees,~~390~~ consultants, and ~~$357,936~~parties ~~for~~to ~~the~~collaborative ~~three~~agreements ~~months~~to ~~ended~~execute ~~August~~confidentiality ~~31,~~agreements ~~2017~~upon ~~and~~the ~~August~~commencement ~~31,~~of ~~2016,~~employment ~~respectively. The~~or ~~decrease~~consulting inrelationships ~~administrative~~or ~~expenses~~collaborations ~~for~~with ~~the~~us. ~~three~~These ~~month~~agreements ~~period~~generally ~~ended~~provide ~~August~~that ~~31,~~all ~~2017~~confidential ~~compared~~information todeveloped or made known during the ~~same~~course ~~prior~~of ~~year~~the ~~period~~relationship ~~was~~with ~~due~~us is to ~~a decrease~~be inkept ~~stock~~confidential ~~compensation~~and ~~expense~~not to be disclosed to third parties except in specific circumstances.

Professional Fees - Professional expenses were $182,943 and $331,907 for the three months ended August 31, 2017 and August 31, 2016, respectively. The decrease for the three month period ended August 31, 2017 was principally due to the non-recurring nature of fundraising expenses incurred in the three months ended August 31, 2016.28

~~Net Loss Outlook~~Employees

We have ~~not~~two ~~generated any product sales revenues~~employees, ~~have~~our ~~incurred~~president ~~operating~~and ~~losses~~our chief ~~since~~financial ~~inception~~officer. ~~and~~We also have ~~not~~a ~~achieved~~Scientific ~~profitable~~Advisory ~~operations.~~Board ~~Our~~which ~~accumulated~~is ~~deficit~~staffed ~~from inception~~by ~~through~~highly ~~August~~qualified ~~31,~~consultants ~~2017~~with ~~was~~the ~~$100,351,226~~ background and wescientific ~~expect~~expertise towe ~~continue~~need to ~~incur~~carry ~~substantial~~out ~~losses~~our inlong-term ~~future~~business ~~periods~~objectives. We ~~expect~~ believe that our ~~operating~~relationship ~~losses~~with inall ~~future periods will be the result~~ of ~~continued~~our employees ~~research~~ and ~~development~~our ~~expenses~~Scientific ~~relating~~Advisory ~~to PRTX-100,~~Board asis ~~well~~generally ~~as costs incurred in preparation for the potential commercialization of PRTX-100~~good.

InCritical ~~addition~~Accounting to additional financing, we are highly dependent on the success of our research and development efforts and, ultimately, upon regulatory approval and market acceptance of our products under development, particularly our lead product candidate, PRTX-100. We may never receive regulatory approval for any of our product candidates, generate product sales revenues, achieve profitable operations or generate positive cash flows from operations, and even if profitable operations are achieved, they may not be sustained on a continuing basis.Policies

26 Our financial statements are prepared in conformity with accounting principles generally accepted in the United States of America. Note 3 to the financial statements describes the significant accounting policies and methods used in the preparation of our financial statements.

~~Liquidity~~We have identified the policies below as some of the more critical to our business and ~~Capital~~the ~~Resources~~understanding of our financial position and results of operations. These policies may involve a high degree of judgment and complexity in their application and represent the critical accounting policies used in the preparation of our financial statements. Although we believe our judgments and estimates are appropriate and correct, actual future results may differ from estimates. If different assumptions or conditions were to prevail, the results could be materially different from these reported results. The impact and any associated risks related to these policies on our business operations are discussed throughout this Report where such policies affect our reported and expected financial results.

~~Since~~The ~~1999,~~preparation weof ~~have~~our ~~incurred~~financial ~~significant~~statements, ~~losses~~in ~~and~~conformity wewith ~~expect~~accounting toprinciples ~~experience~~generally ~~operating~~accepted ~~losses~~in ~~and~~the ~~negative~~United ~~operating~~States, ~~cash~~requires ~~flow~~management ~~for~~to ~~the~~make ~~foreseeable~~estimates ~~future.~~and ~~Historically,~~assumptions ~~our~~that ~~primary~~affect ~~source~~the ofreported ~~cash~~amounts toof ~~meet~~assets, ~~short-term~~liabilities and ~~long-term~~equity ~~liquidity~~and ~~needs~~disclosure ~~has~~of ~~been~~contingent ~~the~~assets ~~sale~~and ofliabilities ~~shares~~at the date of ~~our~~the ~~Common~~financial ~~Stock~~statements and ~~loans~~ ~~from~~the ~~our~~reported ~~majority~~amounts ~~stockholder~~of expenses during the reporting period. WeThese estimates have ~~issued~~a ~~shares~~material inimpact on ~~private~~our ~~placements~~financial atstatements ~~discounts~~and toare ~~then~~discussed ~~current~~in ~~market~~detail ~~price~~throughout this Report.

OnAs ~~December~~part 2,of ~~2009~~the process of preparing our financial statements, we ~~entered~~are ~~into~~required to estimate income taxes in each of the ~~Facility~~ ~~with~~jurisdictions ~~Niobe~~in towhich ~~provide~~we usoperate. This process involves estimating actual current tax expense together with upassessing totemporary ~~$2,000,000~~differences resulting from differing treatment of ~~additional~~items ~~working~~for ~~capital~~tax and accounting purposes. These differences result in ~~the~~deferred ~~form~~tax ofassets ~~secured~~and ~~loans~~liabilities, atwhich ~~any~~are ~~time~~included within the balance sheet. ~~prior~~We tomust ~~June~~then ~~30,~~assess ~~2012~~the ~~subject~~likelihood tothat our ~~achievement~~deferred oftax ~~certain~~assets ~~predetermined~~will ~~benchmarks.~~be Onrecovered ~~February~~from ~~11,~~future ~~2011~~taxable income and to the extent we ~~received~~believe $2that recovery is not likely,~~000,000 of~~ ~~additional~~we ~~working~~must ~~capital~~establish ~~from~~a ~~Niobe~~valuation ~~under~~allowance. In the ~~Facility,~~event ~~and~~that ~~issued~~we determine that we would be able to ~~Niobe~~realize ~~the~~deferred $2tax ~~million~~assets ~~Secured~~in ~~Convertible~~the ~~Note.~~future Onin excess of the ~~same~~ ~~date~~net recorded amount, ~~Niobe~~an ~~converted~~adjustment to the $1deferred ~~Million~~tax ~~Secured~~asset valuation ~~Note~~allowance ~~and~~would ~~accrued~~increase ~~interest~~income ~~thereon,~~in ~~into~~the ~~4,510,870~~period ~~shares~~such ofdetermination ~~our~~was ~~Common Stock~~made.

OnWe ~~August~~account ~~27,~~for ~~2013,~~our stock option grants under ~~Niobe~~the ~~elected~~provisions toof ~~convert~~the accounting guidance for Share-Based Payments. Such guidance requires the ~~principal~~recognition ~~and~~of ~~accrued~~the ~~interest~~fair value of share-based ~~$2,155,000~~compensation ~~under~~in the $2statements ~~Million~~of ~~Secured~~operations. ~~Convertible~~The ~~Note~~fair ~~into~~value 9of our stock option awards was estimated using a Black-Scholes option valuation model. This model requires the input of highly subjective assumptions and elections in adopting and implementing this guidance,~~369,565~~ including expected stock price volatility and the estimated life of each award. The fair value of share-based awards ~~shares~~is amortized over the vesting period of ~~Common~~the ~~Stock~~award and we have elected to use the straight-line method for awards granted after the adoption of this guidance.

~~From~~Results ~~February 1, 2012 through August 27, 2013 we raised an aggregate~~ of ~~$9,000,000 of working capital pursuant to seven loans from Niobe, in varying principal amounts and issued to Niobe the Secured Notes.~~Operations

AsFor ~~described above, on October 11, 2013 we issued~~ the ~~Consolidated~~Three ~~Note~~Months toEnded ~~Niobe. The~~February face amount of the Consolidated Note reflects the $9.0 million aggregate principal amount of the Secured Notes plus interest accrued at 3% per annum on each note from its respective date of issuance. Our obligations under the Consolidated Note are secured by a first priority perfected security interest in all of our assets pursuant to a Consolidated28, ~~Amended~~2018 and ~~Restated~~February ~~Security Agreement dated October 11~~28, ~~2013.~~ 2017

OnResearch ~~January~~and 23Development Expenses - Research and Development expenses (“R&D Expenses”) were $536,815 ~~2014~~and $814,002 wefor ~~consummated~~the athree ~~private~~months ended February 28, 2018 ~~placement~~and ~~financing~~February to28, ~~accredited~~2017, ~~investors~~respectively. The ofdecrease ~~471~~in R&D Expenses for the three month period ended February 28,~~334~~ ~~shares~~2018 compared ofto ~~Common~~the ~~Stock~~three atmonth ~~$6.00~~period ~~per~~ended ~~share~~February 28, ~~yielding~~2017 ~~gross~~was ~~proceeds~~primarily the result of ~~$2,828,000~~a decrease in the activities associated with the manufacturing of PRTX-100.

On November 4, 2014, we entered into the 2014 Credit Facility Agreement pursuant to which we may borrow up to an additional $5 million from Niobe, in the form of secured loans, in accordance with the 2014 Credit Facility Agreement at any time prior to the December 31, 2015 expiration date. Each loan made under the 2014 Credit Facility Agreement is represented by an Original Note and secured by a first priority perfected security interest in all of our assets.29

InThere ~~addition,~~are onsignificant ~~November~~risks 4,and ~~2014, the Consolidated~~uncertainties ~~Note~~inherent ~~was~~in ~~further~~the ~~amended~~preclinical toand ~~increase~~clinical ~~the~~studies ~~threshold~~associated ~~amount~~with ~~requiring~~our aresearch ~~Mandatory~~and ~~Prepayment~~development ~~from $7~~program.5 ~~million~~These tostudies ~~more~~may ~~than~~yield varying ~~$10~~results ~~million. As~~that acould ~~result~~delay, ~~partial~~limit ~~prepayment~~or ~~will~~prevent ~~now~~a beprogram’s ~~triggered~~advancement inthrough the ~~event~~various stages of aproduct ~~Liquidity~~development and ~~Event~~significantly inimpact ~~which~~the wecosts ~~receive~~to ~~gross~~be ~~proceeds~~incurred, and time involved, in ~~excess of~~bringing ~~$10~~a ~~million~~program to completion. ~~All~~As ~~other~~a ~~terms~~result, ~~and~~the ~~provisions~~costs to ofcomplete ~~the~~such ~~Consolidated~~programs, ~~Note~~as ~~remained~~well ~~unchanged~~as ~~and~~the period in ~~full~~which ~~force~~net ~~and~~cash ~~effect~~outflows from such programs are expected to be incurred, are not reasonably estimable.

OnAdministrative ~~December~~Expenses 1,- ~~2015, the 2014 Credit Facility~~Administrative ~~was~~expenses ~~amended~~were ~~to increase the funds available for loans to us to~~ $~~7.5~~867,839 ~~million~~ and to$127,616 ~~extend~~for the ~~expiration~~three ~~date~~months ofended ~~such~~February ~~credit facility to December 31~~28, ~~2016~~2018 ~~pursuant to which we entered into the Amended~~ and ~~Restated~~February ~~Agreement.~~28, ~~Each~~2017, ~~loan under the Amended and Restated~~respectively. The ~~Agreement~~increase ~~has~~in ~~been~~administrative ~~and~~expenses ~~will~~for bethe ~~represented~~three bymonth aperiod ~~New~~ended ~~Note.~~February ~~In addition~~28, ~~the~~2018 ~~Security~~compared ~~Agreement~~to ~~was~~the ~~also~~same ~~amended~~prior ~~and~~year ~~restated~~period towas ~~secure~~due ~~our~~to ~~obligations~~an ~~under~~increase ~~all~~in ~~the~~stock ~~Original~~compensation ~~Notes and all the New Notes~~expense.

OnProfessional ~~June~~Fees 3,- ~~2016,~~Professional weexpenses ~~filed~~were ~~amendment~~$151,943 #1and to$178,588 ~~the~~for ~~Registration Statement on Form S-1 with~~ the ~~U.S.~~three ~~Securities~~months ~~and~~ended ~~Exchange~~February ~~Commission (SEC) (SEC File No. 333-206008)~~28, ~~originally filed~~2018 onand ~~July~~February 3128, ~~2015~~2017, ~~with respect to a proposed public offering of our securities~~respectively. WeThe ~~are~~decrease ~~actively~~for ~~seeking~~the ~~sources~~three ofmonth ~~financing~~period toended ~~fund~~February ~~our continuing operations and development programs. To raise additional capital~~28, we2018 ~~may~~was ~~sell~~principally ~~equity~~due ~~or debt securities. There can be no assurance that we will be able~~ to ~~complete~~a ~~any~~decrease ~~future financing transaction~~ in alegal ~~timely manner or on acceptable terms or otherwise~~fees. ~~If we are not able to raise additional cash, we may be forced to delay, curtail, or cease our operations.~~

OnFor ~~June 30, 2016,~~ the ~~2014~~Nine ~~Credit~~Months ~~Facility~~Ended ~~was~~February again amended to increase the funds available for loans to us to $9.0 million pursuant to the Second Amended and Restated Agreement. Each loan under the Second Amended and Restated Agreement has been represented by a New Note. In addition28, ~~the~~2018 ~~Security Agreement was also amended~~ and ~~restated~~February ~~to secure our obligations under all the notes issued under the 2014 Credit Facility as of June 30~~28, ~~2016 and all the New Notes issued pursuant to the Second Amended and Restated Agreement.~~ 2017

OnResearch ~~August~~and ~~31,~~Development ~~2016,~~Expenses we- ~~and Niobe agreed~~R&D toExpenses ~~extend~~were ~~the~~$1,766,693 ~~maturity~~and ~~date~~$1,738,842 offor the ~~Consolidated~~nine ~~Note~~months ~~and~~ended ~~the~~February ~~maturity~~28, ~~dates~~2018 ofand ~~all~~February ~~thirteen~~28, ~~outstanding~~2017, ~~Original~~respectively. The ~~Notes~~decrease ~~with~~in ~~an aggregate~~R&D ~~principal~~Expenses ~~amount~~for ofthe ~~$5,030,000,~~nine ~~from~~month ~~September~~period 1ended February 28, ~~2016~~2018 compared to ~~September~~the 1,nine ~~2017.~~month ~~All~~period ~~other~~ended ~~terms~~February 28, ~~and~~2017 ~~provisions~~was ofprimarily the ~~Consolidated Note~~result ~~and~~of ~~Original~~a ~~Notes~~decrease ~~remained~~in ~~unchanged~~the ~~and~~activities inassociated ~~full~~with ~~force~~the ~~and~~manufacturing ~~effect~~of PRTX-100.

OnThere ~~October~~are ~~31,~~significant ~~2016, the~~risks ~~funds~~and ~~available~~uncertainties inherent ~~for~~in ~~loans to us under~~ the ~~2014~~preclinical ~~Credit Facility was increased to $11.25 million~~ and ~~the~~clinical ~~expiration~~studies ~~date~~associated ~~was extended~~with toour ~~June~~research ~~15, 2017 pursuant to the Third Amended~~ and ~~Restated~~development ~~Agreement~~program. ~~Each~~These ~~loan~~studies ~~under~~may ~~the~~yield varying ~~Third~~results ~~Amended~~that ~~and~~could ~~Restated Agreement~~delay, ~~will~~limit beor ~~represented~~prevent by a ~~2018~~program’s ~~Note.~~advancement ~~The~~through ~~Security~~the ~~Agreement~~various ~~was~~stages ~~also~~of ~~amended~~product development and ~~restated~~significantly toimpact ~~secure our obligations under all~~ the ~~notes~~costs ~~issued~~to ~~under~~be ~~the~~incurred, ~~2014~~and ~~Credit~~time ~~Facility as of October 31~~involved, ~~2016~~in ~~and~~bringing ~~all~~a ~~the~~program ~~2018~~to ~~Notes~~completion. InAs ~~addition~~a result, wethe ~~and Niobe also~~costs ~~agreed~~ to ~~extend~~complete tosuch ~~March 31~~programs, ~~2018,~~as ~~the~~well ~~maturity~~as ~~dates of~~ the ~~Consolidated~~period ~~Note~~in ~~and~~which ~~all~~net ~~the~~cash ~~notes~~outflows ~~issued~~from ~~and~~such ~~outstanding~~programs ~~under the~~are ~~2014~~expected ~~Credit~~to ~~Facility~~be asincurred, ofare not ~~October~~reasonably ~~31, 2016~~estimable.

27 Administrative Expenses - Administrative expenses were $1,163,517 and $580,031 for the nine months ended February 28, 2018 and February 28, 2017, respectively. The increase in administrative expenses for the nine month period ended February 28, 2018 compared to the same prior year period was due to an increase in stock compensation expense.

AsProfessional ofFees ~~May~~- ~~31,~~Professional ~~2017~~expenses were $475,981 and $724,626 for the ~~outstanding~~nine ~~principal~~months ~~balance~~ended ~~under~~February ~~the~~28, ~~2014~~2018 ~~Credit~~and ~~Facility~~February ~~totaled~~28, ~~$11~~2017,~~080,000~~ respectively. ~~During~~The decrease for the ~~year~~nine month period ended ~~May~~February 3128, ~~2017,~~2018 wewas ~~borrowed an~~principally ~~aggregate~~due to a decrease in legal and banking fees related to our filing of ~~$3,980,000~~Amendment #1 to the Registration Statement on Form S-1 in June 2016.

OnNet ~~June~~Loss 1, 2017, the 2014 Credit Facility was amended to increase the funds available for loans to us to $13.05 million and to extend the expiration date of such facility to March 31, 2018 (the “Fourth Amended and Restated Agreement”). Each loan under the Fourth Amended and Restated Agreement will be represented by a 2018 Note. The Security Agreement was also amended and restated to also secure our obligations under all the 2018 Notes issued pursuant to the Fourth Amended and Restated Agreement.Outlook

OnWe ~~June~~have ~~15,~~not ~~2017~~generated any product sales revenues, ~~July~~have ~~10,~~incurred ~~2017~~operating losses since inception and ~~August~~have ~~10,~~not ~~2017,~~achieved weprofitable ~~borrowed~~operations. ~~$290,000,~~Our ~~$290~~accumulated deficit from inception through February 28,~~000~~ ~~and~~2018 was $~~290~~103,~~000~~077,137 ~~respectively,~~and ~~under~~we ~~the~~expect ~~2014~~to ~~Credit~~continue ~~Facility~~to ~~pursuant~~incur substantial losses in future periods. We expect that toour ~~the~~operating ~~Fourth~~losses ~~Amended~~in ~~and~~future ~~Restated~~periods ~~Agreement~~will be the result of continued research and ~~issued~~development ~~Niobe~~expenses arelating ~~new~~to ~~2018~~PRTX-100, as ~~Note~~well ~~for~~as ~~each~~costs ~~borrowing~~incurred in ~~the~~preparation ~~same~~for ~~principal~~the ~~amount~~potential commercialization of ~~each~~ ~~loan~~PRTX-100.

OnIn ~~August~~addition ~~22,~~to ~~2017~~additional financing, we ~~and~~are highly ~~Niobe~~dependent ~~agreed~~on ~~to extend~~ the ~~maturity~~success ~~date~~ of ~~all~~our ~~outstanding~~research ~~notes~~and ~~issued~~development toefforts ~~Niobe~~and, ~~from~~ultimately, ~~the~~upon ~~current~~regulatory ~~maturity~~approval ~~date~~and ofmarket ~~March~~acceptance ~~31,~~of ~~2018~~our toproducts aunder ~~new~~development, ~~maturity~~particularly ~~date~~our oflead ~~September~~product 1candidate, ~~2018~~PRTX-100. ~~All~~We ~~other~~may ~~terms~~never ~~and~~receive ~~provisions~~regulatory approval for any of ~~such~~our ~~notes~~product ~~remained~~candidates, ~~unchanged~~generate ~~and in~~product ~~full~~sales ~~force~~revenues, achieve profitable operations or generate positive cash flows from operations, and ~~effect~~even if profitable operations are achieved, they may not be sustained on a continuing basis.

~~Subsequent~~Liquidity ~~Events~~and Capital Resources

OnSince ~~September 15~~1999, ~~2017,~~we have incurred significant losses and we ~~borrowed~~expect anto ~~additional~~experience ~~$290,000~~operating ~~under~~losses and negative operating cash flow for the ~~terms~~foreseeable future. Historically, our primary source of cash to meet short-term and long-term liquidity needs has been the ~~Fourth~~sale ~~Amended~~of shares of our Common Stock and ~~Restated~~loans from ~~Agreement~~our ~~and~~majority ~~issued~~stockholder. ~~Niobe~~We ahave ~~New~~issued ~~2018~~shares ~~Note~~in ~~for~~private ~~the~~placements ~~loan~~at indiscounts ~~the~~to ~~same~~then ~~principal~~current ~~amount~~market price.

~~Net~~On ~~Cash~~December ~~Used~~2, 2009, we entered into the Facility with Niobe to provide us with up to $2,000,000 of additional working capital in ~~Operating~~the ~~Activities~~form of secured loans at any time prior to June 30, 2012 subject to our achievement of certain predetermined benchmarks. On February 11, 2011 we received $2,000,000 of additional working capital from Niobe under the Facility, and ~~Operating~~issued ~~Cash~~to ~~Flow~~Niobe ~~Requirements~~the ~~Outlook~~$2 million Secured Convertible Note. On the same date, Niobe converted the $1 Million Secured Note and accrued interest thereon, into 4,510,870 shares of our Common Stock.

~~Our~~On ~~operating cash outflows for the three months ended~~ August 3127, ~~2017 and August 31~~2013, ~~2016 have resulted primarily from research and development expenditures associated~~Niobe ~~for~~elected ~~PRTX-100 and administrative purposes. We expect~~ to ~~continue~~convert tothe ~~use~~principal ~~cash resources to fund operating losses~~ and ~~expect to~~accrued ~~continue~~interest toof ~~incur~~$2,155,000 ~~operating~~under ~~losses~~the in$2 ~~this~~Million ~~fiscal~~Secured ~~year~~Convertible ~~and~~Note ~~beyond~~into ~~due~~9,369,565 shares toof ~~continuing~~Common ~~research and development activities~~Stock.

~~Net~~From ~~Cash~~February ~~Used~~1, 2012 through August 27, 2013 we raised an aggregate of $9,000,000 of working capital pursuant to seven loans from Niobe, in ~~Investing~~varying ~~Activities~~principal amounts and ~~Investing Requirements~~issued ~~Outlook~~to Niobe the Secured Notes.

WeAs dodescribed ~~not~~above, ~~expect~~on toOctober 11, 2013 we beissued ~~required~~the Consolidated Note to ~~make~~Niobe. The ~~any~~face ~~significant~~amount ~~investments~~of inthe ~~information~~Consolidated ~~technology~~Note ~~and~~reflects ~~laboratory~~the ~~equipment~~$9.0 tomillion ~~support~~aggregate principal amount of the Secured Notes plus interest accrued at 3% per annum on each note from its respective date of issuance. Our obligations under the Consolidated Note are secured by a first priority perfected security interest in all of our ~~future~~assets ~~research~~pursuant to a Consolidated, Amended and ~~development~~Restated ~~activities~~Security Agreement dated October 11, 2013.

WeOn ~~may~~January ~~never receive regulatory approval for any of our product candidates~~23, ~~generate product sales revenues~~2014, ~~achieve~~we ~~profitable~~consummated ~~operations~~a ~~or generate positive cash flows~~private ~~from~~placement ~~operations,~~financing ~~and~~to ~~even~~accredited ifinvestors ~~profitable~~of ~~operations are achieved~~471,334 ~~these~~shares ~~may~~of ~~not~~Common beStock ~~sustained~~at ~~on a continuing basis~~$6.00 Weper ~~have~~share, ~~invested a~~yielding ~~significant~~gross ~~portion~~proceeds of ~~our time and financial resources since our inception in the development of PRTX-100~~$2, ~~and our potential to achieve revenues from product sales in the foreseeable future is dependent largely upon obtaining regulatory approval for and successfully commercializing PRTX-100~~828, ~~especially in the United States~~000. ~~We expect to continue to use our cash and investments resources to fund operating and investing activities.~~

~~Off-Balance~~On ~~Sheet~~November ~~Arrangements~~4, 2014, we entered into the 2014 Credit Facility Agreement pursuant to which we may borrow up to an additional $5 million from Niobe, in the form of secured loans, in accordance with the 2014 Credit Facility Agreement at any time prior to the December 31, 2015 expiration date. Each loan made under the 2014 Credit Facility Agreement is represented by an Original Note and secured by a first priority perfected security interest in all of our assets.

AsIn ofaddition, ~~August~~on 31November 4, ~~2017~~2014, wethe ~~had~~Consolidated Note nowas ~~off-balance sheet~~further ~~arrangements~~amended ~~such~~to asincrease ~~guarantees,~~the ~~retained~~threshold oramount ~~contingent~~requiring ~~interest~~a inMandatory ~~assets~~Prepayment ~~transferred~~from $7.5 million to more than $10 million. As a result, ~~obligation~~partial ~~under~~prepayment will now be triggered in the event of a ~~derivative~~Liquidity ~~instrument~~Event in which we receive gross proceeds in excess ~~and~~of ~~obligation~~$10 ~~arising~~million. ~~out~~All other terms and provisions of orthe aConsolidated ~~variable~~Note ~~interest~~remained unchanged and in anfull ~~unconsolidated~~force ~~entity~~and effect.

28 On December 1, 2015, the 2014 Credit Facility was amended to increase the funds available for loans to us to $7.5 million and to extend the expiration date of such credit facility to December 31, 2016 pursuant to which we entered into the Amended and Restated Agreement. Each loan under the Amended and Restated Agreement has been and will be represented by a New Note. In addition, the Security Agreement was also amended and restated to secure our obligations under all the Original Notes and all the New Notes.

~~ITEM~~We 3are actively seeking sources of financing to fund our continuing operations and development programs. ~~QUANTITATIVE~~To ~~AND~~raise ~~QUALITATIVE~~additional ~~DISCLOSURES~~capital, ~~ABOUT~~we ~~MARKET~~may ~~RISK~~sell equity or debt securities. There can be no assurance that we will be able to complete any future financing transaction in a timely manner or on acceptable terms or otherwise. If we are not able to raise additional cash, we may be forced to delay, curtail, or cease our operations.

AsOn aJune ~~smaller~~30, ~~reporting~~2016, ~~company~~the 2014 weCredit ~~are~~Facility ~~not required~~was again amended to ~~provide~~increase the ~~information~~funds ~~required~~available for loans to us to $9.0 million pursuant to the Second Amended and Restated Agreement. Each loan under the Second Amended and Restated Agreement has been represented by ~~this~~a ~~Item~~New Note. In addition, the Security Agreement was also amended and restated to secure our obligations under all the notes issued under the 2014 Credit Facility as of June 30, 2016 and all the New Notes issued pursuant to the Second Amended and Restated Agreement.

~~ITEM 4. CONTROLS AND PROCEDURES~~31

~~(a)~~On ~~Evaluation~~August 31, 2016, we and Niobe agreed to extend the maturity date of ~~Disclosure~~the ~~Controls~~Consolidated Note and ~~Procedures~~the maturity dates of all thirteen outstanding Original Notes with an aggregate principal amount of $5,030,000, from September 1, 2016 to September 1, 2017. All other terms and provisions of the Consolidated Note and Original Notes remained unchanged and in full force and effect.

~~Our~~On ~~management~~October 31, ~~with~~ 2016, the ~~participation~~funds ofavailable ~~both~~for loans ofto ~~our~~us ~~president~~under ~~and~~the ~~chief~~2014 ~~financial~~Credit ~~officer,~~Facility ~~carried~~was ~~out~~increased anto ~~evaluation~~$11.25 ofmillion and the ~~effectiveness~~expiration ofdate ~~our~~was ~~“disclosure controls~~extended ~~and~~to ~~procedures”~~June ~~(as~~15, ~~defined~~2017 pursuant into the ~~Securities~~Third ~~Exchange~~Amended ~~Act~~and ofRestated ~~1934,~~Agreement. asEach ~~amended~~loan (under the ~~“Exchange~~Third ~~Act”), Rules~~Amended ~~13a-15(e)~~ and ~~15-d-15(e))~~Restated asAgreement ofwill ~~the~~be ~~end of the period covered~~ represented by ~~this~~a ~~Report~~2018 ~~(the “Evaluation Date”)~~Note. ~~Based~~The ~~upon that~~Security ~~evaluation,~~Agreement ~~both~~was ofalso ~~our~~amended ~~president~~ and ~~chief~~restated ~~financial~~to ~~officer~~secure ~~concluded~~our ~~that~~obligations asunder ofall the ~~Evaluation~~notes ~~Date,~~issued ~~our disclosure controls~~under ~~and~~the ~~procedures~~2014 ~~are~~Credit ~~effective~~Facility toas ~~ensure~~of ~~that~~October ~~information~~31, ~~required~~2016 toand beall ~~disclosed~~the by2018 usNotes. inIn ~~the~~addition, ~~reports that~~ we ~~file~~and orNiobe ~~submit~~also ~~under the~~agreed ~~Exchange~~to ~~Act~~extend ~~(i)~~to ~~is recorded~~March 31, ~~processed~~2018, ~~summarized~~the ~~and~~maturity ~~reported,~~dates ~~within~~of the ~~time~~Consolidated ~~periods~~Note ~~specified~~and inall the ~~SEC’s~~notes ~~rules and~~issued ~~forms~~ and ~~(ii)~~outstanding isunder ~~accumulated~~the ~~and~~2014 ~~communicated~~Credit ~~to our management, including our president and our chief financial officer,~~Facility as ~~appropriate~~of toOctober ~~allow~~31, ~~timely decisions regarding required disclosure~~2016.

~~(b)~~As ~~Changes~~of inMay ~~Internal~~31, ~~Control~~2017, ~~over~~the outstanding ~~Financial~~principal ~~Reporting~~balance under the Senior Secured Debt to Niobe totaled $20,299,366, including $9,219,366 under the Consolidated Note and $11,080,000 under the 2014 Credit Facility.

~~There~~On ~~were~~June no1, ~~changes~~2017, inthe ~~our~~2014 ~~internal~~Credit ~~controls~~Facility was amended to increase the funds available ~~over~~for ~~financial~~loans ~~reporting~~to ~~that~~us ~~occurred~~to ~~during~~$13.05 ~~the~~million ~~quarter~~and ~~covered~~to byextend ~~this~~the ~~Report~~expiration ~~that~~date ~~has~~of ~~materially~~such ~~affected~~facility to March 31, or2018 (the “Fourth Amended and Restated Agreement”). Each loan under the Fourth Amended and Restated Agreement is ~~reasonably~~represented by a 2018 Note. ~~likely~~The Security Agreement was also amended and restated to ~~materially~~also ~~affect,~~secure our ~~internal~~obligations ~~control~~under ~~over~~all ~~financial~~the ~~reporting~~2018 Notes issued pursuant to the Fourth Amended and Restated Agreement.

~~PART~~On IIAugust –22, ~~OTHER~~2017, ~~INFORMATION~~we and Niobe agreed to extend the maturity date of all outstanding notes issued to Niobe from the current maturity date of March 31, 2018 to a new maturity date of September 1, 2018. All other terms and provisions of such notes remained unchanged and in full force and effect.

~~ITEM~~During 6the nine months ended February 28, 2018, we borrowed an aggregate of $1,970,000; $290,000 on June 15, 2017, $290,000 on July 10, 2017, $290,000 on August 10, 2017, $290,000 on September 15, 2017, $290,000 on October 23, 2017, $200,000 on November 17, 2017, $220,000 on December 15, 2017 and $100,000 on January 12, 2018. ~~EXHIBITS~~Prior to the Offering (described below), the outstanding principal balance under the 2014 Credit Facility totaled $13,050,000.

Exhibit No.	Description
10.1	Final Form of the Fourth Amended and Restated 2014 Credit Facility Agreement between the Company and Niobe dated as of June 1, 2017	Incorporated by reference to Exhibit 10.32 to the Company’s Annual Report on Form 10-K filed on August 23, 2017.
10.2	Final Form of the Sixth Consolidated, Amended and Restated Security Agreement between the Company and Niobe dated as of June 1, 2017	Incorporated by reference to Exhibit 10.33 to the Company’s Annual Report on Form 10-K filed on August 23, 2017.
10.3	Second Consolidated and Secured Notes Modification Agreement between the Company and Niobe dated August 22, 2017	Incorporated by reference to Exhibit 10.34 to the Company’s Annual Report on Form 10-K filed on August 23, 2017.
31.1	Certification of Chief Executive Officer pursuant to Section 302(a) of the Sarbanes-Oxley Act	Filed herewith.
31.2	Certification of Chief Financial Officer pursuant to Section 302(a) of the Sarbanes-Oxley Act	Filed herewith.
32.1	Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act	Furnished herewith in accordance with Item 601 (32) (ii) of Regulation S-K.
32.2	Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act	Furnished herewith in accordance with Item 601 (32) (ii) of Regulation S-K.
101.INS	XBRL Instance Document.	Filed herewith.
101.SCH	XBRL Taxonomy Extension Schema Document.	Filed herewith.
101.CAL	XBRL Taxonomy Extension Calculation Linkbase Document.	Filed herewith.
101.LAB	XBRL Taxonomy Extension Label Linkbase Document.	Filed herewith.
101.PRE	XBRL Taxonomy Extension Presentation Linkbase Document.	Filed herewith.
101.DEF	XBRL Taxonomy Extension Definition Linkbase Document.	Filed herewith.

On February 28, 2018, we raised an aggregate of $1.425 million from eight accredited investors in the Offering of Senior Notes. No commissions were payable in connection with the Offering which was principally sold to our existing stockholders. Proceeds of the Offering will be used for working capital purposes, principally to fund ongoing clinical trials and studies and related activities. No registration rights were granted to the investors in the Offering.

29 The Senior Notes are convertible into shares of common of stock at a price of $0.20 per share at the option of the holder prior to maturity or earlier prepayment, accrue interest at the rate of 10% per annum and are due on February 28, 2023. Upon conversion, the note holder will receive 5,000 shares of our common stock for each $1,000 of principal or accrued interest converted. Two-thirds of the shares issuable upon any conversion of the Senior Notes will be acquired by us from Niobe for nominal consideration ($.01 per share) pursuant to the Call Agreement. As a result, for each $1,000 of principal or interest converted, we will issue approximately 1,667 new shares. Accordingly, the effective conversion price will be approximately $0.60 per share of common stock, with Niobe incurring substantially all of the associated dilution. The closing price of per share of common stock on the date of the Offering was $0.45.

~~SIGNATURES~~We evaluated the conversion feature of the Senior Notes and determined that under the accounting guidance for “Accounting for Convertible Securities with Beneficial Conversion Features” that a value should be attributed to the embedded conversion feature. On February 28, 2018, the date of issuance of the Senior Notes, the fair market value of Common Stock was $0.45 per share. We determined the allocation to the conversion feature to be $1.425 million, which reduced the face amount of the Senior Notes carried on our balance sheet to -$0-. This discount will be amortized over 60 months and will serve to increase the interest expense of the Senior Notes during the term of such notes.

~~In accordance with 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.~~32

Date: October 11, 2017	PROTALEX, INC.
	By:	/s/ Arnold P. Kling
		Arnold P. Kling, President
		(Principal Executive Officer)

In addition, as a condition to the consummation of the Offering, on February 28, 2018 Niobe converted $22,269,366 of outstanding notes due September 30, 2018 (the aggregate outstanding principal balance under the Consolidated Note and the 2014 Credit Facility as of February 28, 2018) into 18,557,805 shares of common stock at a conversion price of $1.20 per share. Consequently, other than the Senior Notes issued in the Offering, the only remaining indebtedness on our balance sheet at February 28, 2018 is approximately $1,974,000, representing the accrued but unpaid interest on the notes converted by Niobe.

Date: October 11, 2017
	By:	/s/ Kirk M. Warshaw
		Kirk M. Warshaw, Chief Financial Officer
		(Principal Financial Officer)

Net Cash Used in Operating Activities and Operating Cash Flow Requirements Outlook

30 Our operating cash outflows for the nine months ended February 28, 2018 and February 28, 2017 have resulted primarily from research and development expenditures associated for PRTX-100 and administrative purposes. We expect to continue to use cash resources to fund operating losses and expect to continue to incur operating losses in this fiscal year and beyond due to continuing research and development activities.

Net Cash Used in Investing Activities and Investing Requirements Outlook

We do not expect to be required to make any significant investments in information technology and laboratory equipment to support our future research and development activities.

We may never receive regulatory approval for any of our product candidates, generate product sales revenues, achieve profitable operations or generate positive cash flows from operations, and even if profitable operations are achieved, these may not be sustained on a continuing basis. We have invested a significant portion of our time and financial resources since our inception in the development of PRTX-100, and our potential to achieve revenues from product sales in the foreseeable future is dependent largely upon obtaining regulatory approval for and successfully commercializing PRTX-100, especially in the United States. We expect to continue to use our cash and investments resources to fund operating and investing activities.

Subsequent Events

On March 13, 2018, we raised an additional $50,000 in the Offering and issued a Senior Note in the principal amount of $50,000 to an accredited investor. In connection with the foregoing, on March 13, 2018, the Call Agreement was amended and restated to also include two-thirds of the shares issuable upon the conversion of this Senior Note.

Off-Balance Sheet Arrangements

As of February 28, 2018, we had no off-balance sheet arrangements such as guarantees, retained or contingent interest in assets transferred, obligation under a derivative instrument and obligation arising out of or a variable interest in an unconsolidated entity.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

As a smaller reporting company we are not required to provide the information required by this Item.

ITEM 4. CONTROLS AND PROCEDURES

(a)

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of both of our president and chief financial officer, carried out an evaluation of the effectiveness of our “disclosure controls and procedures” (as defined in the Securities Exchange Act of 1934, as amended (the “Exchange Act”), Rules 13a-15(e) and 15-d-15(e)) as of the end of the period covered by this Report (the “Evaluation Date”). Based upon that evaluation, both of our president and chief financial officer concluded that as of the Evaluation Date, our disclosure controls and procedures are effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act (i) is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms and (ii) is accumulated and communicated to our management, including our president and our chief financial officer, as appropriate to allow timely decisions regarding required disclosure.

(b)

Changes in Internal Control over Financial Reporting

There were no changes in our internal controls over financial reporting that occurred during the quarter covered by this Report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II – OTHER INFORMATION

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

On February 28, 2018 and March 13, 2018, we raised an aggregate of $1.475 million ($1.425 million as of February 28, 2018) from nine accredited investors in the Offering of Senior Notes. The Senior Notes are convertible into shares of common of stock at a price of $0.20 per share at the option of the holder prior to maturity or earlier prepayment, accrue interest at the rate of 10% per annum and are due on February 28, 2023. Upon conversion, the note holder will receive 5,000 shares of our common stock for each $1,000 of principal or accrued interest converted. Two-thirds of the shares issuable upon any conversion of the Senior Notes will be acquired by us from Niobe for nominal consideration ($.01 per share) pursuant to the Call Agreement, as amended on March 13, 2018. As a result, for each $1,000 of principal or interest converted, we will issue approximately 1,667 new shares. Accordingly, the effective conversion price will be approximately $0.60 per share of common stock, with Niobe incurring substantially all of the associated dilution. The closing price of per share of common stock on the date of the Offering was $0.45.

The Senior Notes were sold for investment and not with a view for distribution. The Senior Notes were issued without registration under the Act pursuant to the exemptions provided under Sections 4(a)(2) and 4(a)(5), and Rule 506 of Regulation D thereof. All of the Senior Notes issued are restricted securities, bear a restrictive legend and will be subject to stop transfer restrictions.

ITEM 6. EXHIBITS

Exhibit
No.	Description
4.1	Final form of the 10% Senior Convertible Note, due February 28, 2023 (included as Exhibit A in Exhibit 10.1).	Incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on March 6, 2018.
10.1	Final Form of the Securities Purchase Agreement dated February 28, 2018 (including Form of the 10% Senior Convertible Note, due February 28, 2023).	Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on March 6, 2018.
10.2	Final Form of Exchange Agreement dated February 28, 2018.	Incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed on March 6, 2018.
10.3	Final Form of the Amended & Restated Call Agreement dated March 13, 2018.	Filed herewith.
31.1	Certification of Chief Executive Officer pursuant to Section 302(a) of the Sarbanes-Oxley Act	Filed herewith.
31.2	Certification of Chief Financial Officer pursuant to Section 302(a) of the Sarbanes-Oxley Act	Filed herewith.
32.1	Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act	Furnished herewith in accordance with Item 601 (32) (ii) of Regulation S-K.
32.2	Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act	Furnished herewith in accordance with Item 601 (32) (ii) of Regulation S-K.
101.INS	XBRL Instance Document.	Filed herewith.
101.SCH	XBRL Taxonomy Extension Schema Document.	Filed herewith.
101.CAL	XBRL Taxonomy Extension Calculation Linkbase Document.	Filed herewith.
101.LAB	XBRL Taxonomy Extension Label Linkbase Document.	Filed herewith.
101.PRE	XBRL Taxonomy Extension Presentation Linkbase Document.	Filed herewith.
101.DEF	XBRL Taxonomy Extension Definition Linkbase Document.	Filed herewith.

SIGNATURES

In accordance with 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.

Date: April 13, 2018	PROTALEX, INC.

	By:	/s/ Arnold P. Kling
		Arnold P. Kling, President
		(Principal Executive Officer)

Date: April 13, 2018
	By:	/s/ Kirk M. Warshaw
		Kirk M. Warshaw, Chief Financial Officer
		(Principal Financial Officer)

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