UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

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

For the quarterly period ended ~~September~~March 3031, ~~2025~~2026

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

For the transition period from __________ to __________

Commission file number: 001-36333

Bio-Path Holdings, Inc.

(Exact name of registrant as specified in its charter)


Delaware		87-0652870
(State or other jurisdiction of		(I.R.S. Employer
incorporation or organization)		Identification No.)


625 Stanwix St. #2407, Pittsburgh, Pennsylvania		15222
(Address of principal executive offices)		(Zip Code)

(630) 708-0750

(Registrant’s telephone number, including area code)

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

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. Yes ☒☐ No☒ ☐

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

by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a 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 ☒	Smaller reporting company ☒
		Emerging growth company ☐

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

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

At ~~January~~May 920, 2026, the Company had 950,~~242~~297,~~151~~451 outstanding ~~shares~~ shares of common stock, par value $0.001 per share, with a total value of $~~542~~1,~~514~~664,846.

Table of Contents

Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to “we,” “our,” “us,” “the Company” and “Bio-Path” refer to Bio-Path Holdings, Inc. and its subsidiary. Bio-Path Holdings, Inc.’s wholly-owned subsidiary, Bio-Path, Inc., is sometimes referred to herein as “Bio-Path Subsidiary.”

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements can be identified by words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” “project,” “goal,” “strategy,” “future,” “likely,” “may,” “should,” “will” and variations of these words and similar references to future periods, although not all forward-looking statements contain these identifying words. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks, uncertainties and changes in circumstances, including those discussed in “Item 1A. Risk Factors” to Part I of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in other reports or documents we file with the U.S. Securities and Exchange Commission (“SEC”). As a result, our actual results and financial condition may differ materially from those expressed or forecasted in the forward-looking statements, and you should not rely on such forward-looking statements. We can give no assurances that any of the events anticipated by the forward-looking statements will occur or, if any of them do, what impact they will have on our results of operations and financial condition. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following:

•

our lack of significant revenue to date, our history of recurring operating losses and our expectation of future operating losses;

•

our need for substantial additional capital and our need to delay, reduce or eliminate our drug development and commercialization efforts if we are unable to raise additional capital;

•

the highly competitive nature of the pharmaceutical and biotechnology industry and our ability to compete effectively;

•

the success of our plans to use collaboration arrangements to leverage our capabilities;

•

our ability to retain and attract key personnel;

•

the risk of misconduct of our employees, agents, consultants and commercial partners;

•

disruptions to our operations due to expansions of our operations;

•

the costs we would incur if we acquire or license technologies, resources or drug candidates;

•

risks associated with product liability claims;

•

our reliance on information technology systems and the liability or interruption associated with cyber-attacks or other breaches of our systems;

•

our ability to use net operating loss carryforwards;

•

provisions in our charter documents and state law that may prevent a change in control;

•

work slowdown or stoppage at government agencies could negatively impact our business;

•

the impact, risks and uncertainties related to global pandemics, including the COVID-19 pandemic, and actions taken by governmental authorities or others in connection therewith;

•

our need to complete extensive clinical trials and the risk that we may not be able to demonstrate the safety and efficacy of our drug candidates;

•

risks that our clinical trials may be delayed or terminated;

•

our ability to obtain domestic and/or foreign regulatory approval for our drug candidates;

•

changes in existing laws and regulations affecting the healthcare industry;

•

our reliance on third parties to conduct clinical trials for our drug candidates;

•

our ability to maintain orphan drug exclusivity for our drug candidates;

•

our reliance on third parties for manufacturing our clinical drug supplies;

•

risks associated with the manufacture of our drug candidates;

•

our ability to establish sales and marketing capabilities relating to our drug candidates;

•

market acceptance of our drug candidates;

•

third-party payor reimbursement practices;

Table of Contents

•

our ability to adequately protect the intellectual property of our drug candidates;

•

infringement on the intellectual property rights of third parties;

•

costs and time relating to litigation regarding intellectual property rights;

•

our ability to adequately prevent disclosure by our employees or others of trade secrets and other proprietary information;

•

our need to raise additional capital;

•

the volatility of the trading price of our common stock;

•

our common stock being thinly traded;

•

our ability to issue shares of common or preferred stock without approval from our stockholders;

•

our ability to pay cash dividends;

•

costs and expenses associated with being a public company; and

•

our ability to maintain effective internal controls over financial reporting.

Please also refer to “Item 1A. Risk Factors” to Part I of our Annual Report on Form 10-K as of the fiscal year ended December 31, 2024, “Item 1A. Risk Factors” to Part II of this Quarterly Report on Form 10-Q and other reports or documents we file with the SEC for a discussion of risks and factors that could cause our actual results and financial condition to differ materially from those expressed or forecasted in this Quarterly Report on Form 10-Q.

Any forward-looking statement made by us in this Quarterly Report on Form 10-Q is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise. However, you should carefully review the risk factors set forth in other reports or documents we file from time to time with the SEC.

Table of Contents

TABLE OF CONTENTS

		Page
PART I - FINANCIAL INFORMATION		54
Item 1.	Financial Statements	54
	Condensed Consolidated Balance Sheets (Unaudited and not reviewed)	54
	Condensed Consolidated Statements of Operations (Unaudited and not reviewed)	65
	Condensed Consolidated Statements of Cash Flows (Unaudited and not reviewed)	76
	Condensed Consolidated Statements of Shareholders’ (Deficit) Equity (Unaudited and not reviewed)	87
	Notes to the Unaudited and not Reviewed Condensed Consolidated Financial Statements	98
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	1816
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	2824
Item 4.	Controls and Procedures	2924
PART II - OTHER INFORMATION		3025
Item 1.	Legal Proceedings	3025
Item 1A.	Risk Factors	3025
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	3025
Item 3.	Defaults Upon Senior Securities	3025
Item 4.	Mine Safety Disclosures	3025
Item 5.	Other Information	3025
Item 6.	Exhibits	3126
Signature		3227

Table of Contents

PART I – FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

BIO-PATH HOLDINGS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except par value)

	As of September 30,			As of December 31,
	As of March 31,			As of December 31,
	2025			2024
	2026			2025
	(unaudited and not reviewed)
Assets
Current assets
Cash	$	—12		$	~~1,173~~—
Prepaid drug product		474			~~1,074~~474
Other current assets		~~189~~191			~~1,529~~193
Total current assets		~~663~~677			~~3,776~~667
Fixed assets
Right of use operating assets		—			11
Furniture, fixtures & equipment		1,010			1,077
Total Assets	$	677		$	678
Less accumulated depreciation		(1,010	)		(1,054	)
Fixed assets, net		—			23
Right of use operating assets		27			84
Total Assets	$	690		$	3,883
Liabilities & Shareholders' (Deficit) Equity
Current liabilities
Accounts payable	$	45,~~898~~158		$	14,~~274~~910
Notes payable		~~452~~511			—452
Accrued expenses		23,~~963~~020			13,~~938~~004
Derivative liabilities		~~343~~462			—508
Lease liabilities		27—			8311
Total current liabilities		89,~~683~~151			38,~~295~~885
Warrant liability		1112			~~434~~14
Total Liabilities		89,~~694~~163			38,~~729~~899
Shareholders' (deficit) equity
Preferred stock, $.001 par value; 10,000 shares authorized; no shares issued and outstanding		—			—
Preferred stock, $.001 par value; 10,000 shares authorized; 51 and 0 shares issued and outstanding, respectively		1			—
Common stock, $.001 par value; 200,000 shares authorized; 9,242 and 5,768 shares issued and outstanding, respectively		910			69
Common stock to be issued		1—			—1
Additional paid-in capital		117,912			117,649
Additional paid in capital		117,948			117,944
Accumulated deficit		(~~125~~126,~~926~~445	)		(~~117~~126,~~501~~175	)
Total shareholders' (deficit) equity		(8,~~004~~486	)		~~154~~(8,221	)
Total Liabilities & Shareholders' (Deficit) Equity	$	~~690~~677		$	~~3,883~~678

SEE ACCOMPANYING NOTES TO ~~CONDENSED~~ CONSOLIDATED FINANCIAL STATEMENTS

Table of Contents

BIO-PATH HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(Unaudited and not reviewed)

	Three Months Ended September 30,						Nine Months Ended September 30,
	Three Months Ended
	2025			2024			2025			2024
	March, 31,
Operating expenses
	2026			2025
Research and development	$	275		$	1,317		$	6,300		$	5,478
Operating expenses
General and administrative		213			1,317			1,991			3,889
Research and development	$	38		$	1,977
Total operating expenses		488			2,634			8,291			9,367
General and administrative		259			1,264
Net operating loss	$	(488	)	$	(2,634	)	$	(8,291	)	$	(9,367	)
Total operating expenses		297			3,241
Other income (expense)
Net operating income (loss)		(297	)		(3,241	)
Change in fair value of warrant and derivative liabilities		(315	)		515			79			2,216
Other income (expense)
Loss on convertible debt conversions		(43	)					(43	)
Change in fair value of derivatives		48			394
Interest expense		(130	)		4			(170	)		10
Gain on debt settlement		4			—
Total other income (expense)		(488	)		519			(134	)		2,226
Interest expense		(25	)		(5	)
Net loss	$	(976	)	$	(2,115	)	$	(8,425	)	$	(7,141	)
Total other income (expense)		27			389
Net loss per share, basic and diluted	$	(0.11	)	$	(0.70	)	$	(1.07	)	$	(4.05	)
Net loss	$	(270	)	$	(2,852	)
Basic and diluted weighted average number of common shares outstanding		8,521			3,017			7,906			433
Net loss per share, basic and diluted	$	(0.03	)	$	(0.40	)
Basic and diluted weighted average number of common shares outstanding		9,342			7,062

SEE ACCOMPANYING NOTES TO ~~CONDENSED~~ CONSOLIDATED FINANCIAL STATEMENTS

Table of Contents

BIO-PATH HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited and not reviewed)

	Nine Months Ended September 30,
	Three Months Ended
	2025			2024
	March, 31,
	2026			2025
Cash flow from operating activities
Net loss	$	(~~8,425~~270	)	$	(72,~~141~~852	)
Adjustments to reconcile net loss to net cash used in operating activities
Stock-based compensation		~~163~~5			~~439~~108
Amortization of debt issuance costs		809			—5
Amortization of right of use assets		5711			7830
Default on convertible debt		90			—
Loss (gain) on debt conversions		(4	)		—
Loss on convertible debt conversions		43			—
Depreciation		—			2
Depreciation		23			34
Change in fair value of warrant liability		(2	)		(394	)
Change in fair value of warrant liability		(423	)		(2,216	)
Change in fair value of derivative liability		(46	)		—
Change in fair value of derivative liability		343			—
(Increase) decrease in operating assets
Prepaid drug product		~~600~~—			~~101~~600
Other current assets		~~1,340~~2			~~(448~~—	)
Increase (decrease) in operating liabilities
Accounts payable and accrued expenses		~~4,569~~268			1,~~546~~217
Interest payable		—			—
Lease liabilities		(11	)		(29	)
Lease liabilities		(56	)		(87	)
Net cash used in operating activities		(38	)		(1,313	)
Net cash used in operating activities		(1,596	)		(7,694	)
Cash flow from financing activities
Net proceeds from sale of common stock		—			7,204
Net proceeds from exercise of pre-funded warrants		—			1
Net proceeds from exercise of pre-funded warrants		1			—
Proceeds from promissory notes		50			261
Proceeds from promissory notes		422			—
Net cash provided by financing activities		50			262
Net cash provided by financing activities		423			7,204
Net increase (decrease) in cash		12			(1,051	)
Net increase (decrease) in cash		(1,173	)		(490	)
Cash, beginning of period		—			1,173
Cash, beginning of period		1,173			1,052
Cash, end of period	$	12		$	122
Cash, end of period	$	—		$	562
Supplemental disclosure of non-cash activities
Right of use asset recognized in exchange for lease obligation	$	5711		$	—88

SEE ACCOMPANYING NOTES TO ~~CONDENSED~~ CONSOLIDATED FINANCIAL STATEMENTS

Table of Contents

BIO-PATH HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ (DEFICIT) EQUITY

(In thousands)

(Unaudited and not reviewed)

							Additional
	Series S Preferred				Common Stock
	Common Stock					Common Stock	Paid in			Accumulated
Description	Shares		Amount		Shares			Amount			Common Stock To Be Issued				Additional Paid in Capital			Accumulated Deficit			Total
Description	Shares		Amount			To Be Issued	Capital			Deficit				Total
Balance at December 31, 2024		—	$	—		5,768		$	6		$	—				117,649		$	(117,501	)	$	154
Balance at June 30, 2024		2,283	$	2	$	—	$	113,922		$	(112,633	)		$	1,291
Exercise of pre-funded warrants, net of fees		—		—		2,540			2			—				(1	)		—			1
Issuance of common stock and warrants, net of fees and warrant liability		1,427		2		—		(18	)		—				(16	)
Stock-based compensation		—		—		—			—			—				108			—			108
Stock-based compensation		—		—		—		128			—				128
Net loss		—		—		—			—			—				—			(2,852	)		(2,852	)
Net loss		—		—		—		—			(2,115	)			(2,115	)
Balance at March 31, 2025		—	$	—		8,308		$	8		$	—			$	117,756		$	(120,353	)	$	(2,589	)
Balance at September 30, 2024		3,710	$	4	$	—	$	114,032		$	(114,748	)		$	(712	)
Balance at December 31, 2025		—	$	—		9,242		$	9		$	1				117,944		$	(126,175	)	$	(8,221	)
Balance at June 30, 2025		8,308	$	8	$	—	$	117,784		$	(124,950	)		$	(7,158	)
Issuance of stock to be issued		—		—		100			1			(1	)			—			—			—
Stock-based compensation		—		—		—		27			—				27
Issuance of Series S Preferred stock		1		1		—			—			—				(1	)		—			—
Conversion of convertible debt to common stock		934		1		1		101			—				103
Stock-based compensation		—		—		—			—			—				5			—			5
Net loss		—		—		—		—	—		~~(976~~	)—			~~(976~~	)—			(270	)		(270	)
Balance at September 30, 2025		9,242	$	9	$	1	$	117,912		$	(125,926	)		$	(8,004	)
Balance at March 31, 2026		1	$	1		9,342		$	10		$	—			$	117,948		$	(126,445	)	$	(8,486	)

							Additional
	Common Stock					Common Stock	Paid in			Accumulated
Description	Shares		Amount			To Be Issued	Capital			Deficit			Total
Balance at December 31, 2023		618	$	1	$	—	$	108,047		$	(107,607	)	$	441
Issuance of common stock and warrants, net of fees and warrant liability		3,092		3		—		5,546			—			5,549
Stock-based compensation		—		—		—		439			—			439
Net loss		—		—		—		—			(7,141	)		(7,141	)
Balance at September 30, 2024		3,710	$	4	$	—	$	114,032		$	(114,748	)	$	(712	)
Balance at December 31, 2024		5,768	$	6	$	—	$	117,649		$	(117,501	)	$	154
Exercise of pre-funded warrants, net of fees		2,540		2		—		(1	)		—			1
Stock-based compensation		—		—		—		163			—			163
Conversion of convertible debt		1.395		1		1		101			—			103
Net loss		—		—		—		—			(8,425	)		(8,425	)
Balance at September 30, 2025		9,703	$	9	$	1	$	117,912		$	(125,926	)	$	(8,004	)

SEE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

~~SEE ACCOMPANYING NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS~~ 7

Table of Contents

BIO-PATH HOLDINGS, INC.

Notes to the Unaudited and not Reviewed Condensed Consolidated Financial Statements

Unless the context requires otherwise, references in these Notes to the Condensed Consolidated Financial Statements to “we,” “our,” “us,” “the Company” and “Bio-Path” refer to Bio-Path Holdings, Inc. and its subsidiary. Bio-Path Holdings, Inc.’s wholly-owned subsidiary, Bio-Path, Inc., is sometimes referred to herein as “Bio-Path Subsidiary.”

The accompanying unaudited condensed interim financial statements have been prepared in conformity with the authoritative U.S. generally accepted accounting principles (GAAP) for interim financial information and in accordance with the instructions to Form 10-Q pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and, therefore, do not include all information and footnotes required by GAAP for complete consolidated financial statements. In the opinion of management, all adjustments considered necessary for a fair presentation of the results of operations and financial position have been included and all such adjustments are of a normal recurring nature. The unaudited quarterly financial statements should be read in conjunction with the ~~audited~~unaudited financial statements and notes thereto included in the Annual Report on Form 101-K of the Company as of and for the fiscal year ended December 31, ~~2024~~2025. The results of operations for the period ended ~~June~~March 3031, ~~2025~~2026 are not necessarily indicative of the results for a full-year period.

Explanatory Note:

This Quarterly Report on Form 10-Q for the period ended ~~September~~March 3031, ~~2025~~2026 has not been reviewed by an independent registered public accounting firm in accordance with the rules ~~and~~ and regulations of the Securities and Exchange Commission. As a result, this report is considered deficient and may not fully comply with all applicable requirements of the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.

1. Organization and Business

The Company is a clinical and preclinical stage oncology and obesity-focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target-specific protein inhibition for any gene product that is over-expressed in disease. The Company’s drug delivery and antisense technology, called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction by the body’s enzymes when circulating in vivo, incorporated inside of a lipid bilayer having neutral charge. The Company believes this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, the DNAbilize® delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. Through testing in numerous animal studies and dosing in clinical trials, the Company’s DNAbilize® drug candidates have demonstrated an excellent safety profile. DNAbilize® is a registered trademark of the Company. Using DNAbilize® as a platform for drug development and manufacturing, the Company currently has four antisense drug candidates in development to treat at least five different cancer disease indications and one indication in obesity.

The Company’s operations to date have been limited to organizing and staffing the Company, acquiring, developing and securing its technology and undertaking product development for a limited number of product candidates. As the Company has not begun its planned principal operations of commercializing a product candidate, the Company’s activities are subject to significant risks and uncertainties, including the potential requirement to secure additional funding, the outcome of the Company’s clinical trials and failing to operationalize the Company’s current drug candidates before another company develops similar products.

Table of Contents

2. Significant Accounting Policies

Net Loss Per Share

Basic net loss per common share is computed by dividing the net loss for the period by the weighted average number of shares of common stock outstanding during the period. Although there were warrants and stock options outstanding as of September 30, 2025 and 2024, no potential common shares are included in the computation of any diluted per share amount, as they would be antidilutive. Consequently, diluted net loss per share as presented in the condensed consolidated financial statements is equal to basic net loss per share for the ~~nine~~three months ended ~~September~~March 3031, ~~2025~~2026 and ~~2024~~2025. The calculation of diluted earnings per share for ~~2025 did not include 60,254 shares and 13,950,014 shares issuable pursuant to~~ the ~~exercise~~three ofmonths ~~outstanding~~ended ~~common~~March ~~stock~~31, ~~options~~2026 and ~~warrants, respectively, as of September 30,~~ 2025 ~~as the effect would be antidilutive. The calculation of diluted earnings per share for 2024~~ did not include ~~43,393 shares~~ ~~and 5,848,679~~ shares issuable pursuant to the exercise of outstanding common stock options and warrants, ~~respectively,~~ as ~~of September 30, 2024 as~~ the effect would be antidilutive.

Liquidity

The Company’s available cash and cash equivalents of $0.01 million at ~~September~~March 3031, ~~2025~~2026 will not be sufficient to fund liquidity and capital expenditure requirements for the next 12 months from the date of issuance of these consolidated financial statements. Therefore, substantial doubt exists about the Company’s ability to continue as a going concern. The Company expects to continue to incur significant operating expenses for the foreseeable future in connection with its ongoing activities, including conducting clinical trials, manufacturing development and seeking regulatory approval of its drug candidates, prexigebersen, BP1002, BP1003 and BP1001-A. Accordingly, the Company will continue to require substantial additional capital to fund its projected operating requirements. Such additional capital may not be available when needed or on terms favorable to the Company. In addition, the Company may seek additional capital due to favorable market conditions or strategic considerations, even if it believes it has sufficient funds for its current and future operating plan. There can be no assurance that the Company will be able to continue to raise additional capital through the sale of securities in the future. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers and/or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations, financial condition and future prospects.

Segment Reporting

Operating segments are identified as components of an enterprise for which separate discrete financial information is available for evaluation by the chief operating decision maker (“CODM”) in making decisions on how to allocate resources and assess performance. The Company views its operations as and manages its business in one operating segment, as a research and development drug development company. The CODM is the Company’s Interim Chief Executive Officer. The CODM reviews the segment’s loss based on net loss reported on the consolidated statement of operations. The operating segment constitutes all of the consolidated entity and is the level at which the CODM regularly reviews the operating results and performance.

Warrants

The Company determines whether warrants should be classified as a liability or equity. For warrants classified as liabilities, the Company estimates the fair value of the warrants at each reporting period using Level 3 inputs with changes in fair value recorded in the Condensed Consolidated Statement of Operations as change in fair value of warrant liability. The estimates in valuation models are based, in part, on subjective assumptions, including but not limited to stock price volatility, the expected life of the warrants, the risk-free interest rate and the fair value of the common stock underlying the warrants, and could differ materially in the future. The Company will continue to adjust the fair value of the warrant liability at the end of each reporting period for changes in fair value from the prior period until the earlier of the exercise or expiration of the applicable warrant.

Fair Value

The fair values of cash and cash equivalents, accounts payable and accrued liabilities approximate their carrying values because of the short-term maturities of these instruments.

109

Table of Contents

3. Prepaid Drug Product

Advance payments, including non-refundable amounts, for goods or services that will be used or rendered for future clinical development activities are deferred and capitalized. Such amounts will be recognized as an expense as the related goods are delivered or the related services are performed. The Company recognized certain expenses and incurred installment costs for its contract drug manufacturing and raw material suppliers with prepayments totaling $1.1 million as of December 31, 2024 pursuant to drug supply contracts for the manufacture and delivery of prexigebersen for testing in a Phase 2 clinical trial. The Company recognized certain expenses and incurred additional installment costs during ~~the first nine months of~~ 2025, with advanced payments remaining to be expensed totaling $0.5 million as of ~~September~~March 3031, ~~2025~~2026.

4. Other Current Assets

As of ~~September~~March 3031, 2026 and December 31, 2025, other current assets included prepaid expenses of $0.1 million, comprised primarily of $0.1 million and other prepaid expenses. As of December 31, 2024, other current assets included prepaid expenses of $1.5 million, comprised primarily of prepayments of $1.2 million made for the Company’s clinical trials for BP1001-A in solid tumors and BP1002 in AML as well as prepaid insurance of $0.3 million.

5. Accounts Payable

As of ~~September~~March 3031, ~~2025~~2026, current liabilities included accounts payable of $45.92 million, comprised primarily of expenses related to clinical trial expenses of $3.3 million, legal and patent fees of $0.6 million, drug manufacturing development and testing services of $0.4 million, public company registration and filing fees of $0.2 million and professional and consulting fees of $0.2 million. As of December  31, ~~2024~~2025, current liabilities included accounts payable of $14.3 9 million, comprised primarily of expenses related to the Company’s clinical trials of $03.8 3 million, drug manufacturing development and testing services of $0.4  million and legal and patent fees of $0.1 6 million.

6. Notes Payable

As of ~~June~~March 3031, ~~2025~~2026, current liabilities included notes payable of $0.45 million related to the March 2025 Promissory Notes, ~~and~~ the April 2025 Promissory ~~Note~~Notes and the January 2026 Promissory Notes (each as defined below). As of December 31, ~~2024~~ 2025, ~~the~~current ~~Company~~liabilities ~~did~~included notes payable of $0.4 ~~not~~million ~~have~~related ~~any~~to ~~notes~~the March ~~payable~~2025 Promissory Notes and the April 2025 Promissory Note (each as defined below).

On March 6, 2025, the Company entered into a securities purchase agreement with 1800 Diagonal Lending LLC, a Virginia limited liability company (the “First Lender”), an accredited investor, for the issuance and sale of a promissory note in the aggregate principal amount of $161,000 (the “First Promissory Note”) for a purchase price of $140,000 after deducting the original issue discount of $21,000. The First Promissory Note bears a one-time interest charge of twelve percent that was applied on the date of issuance, March 6, 2025. The First Promissory Note shall be paid in five payments with the first payment of $90,160 due on August 30, 2025 and subsequent payments of $22,540 due on September 30, 2025, October 30, 2025, November 30, 2025 and December 30, 2025.

On March 28, 2025, the Company entered into a securities purchase agreement with the First Lender, an accredited investor, for the issuance and sale of a promissory note in the aggregate principal amount of $100,050 (the “Second Promissory Note” and together, with the First Promissory Note, the “March 2025 Promissory Notes”) for a purchase price of $87,000 after deducting the original issue discount of $13,050. The Second Promissory Note bears a one-time interest charge of twelve percent that was applied on the date of issuance, March 28, 2025. The Second Promissory Note shall be paid in five payments with the first payment of $56,028 due on September 30, 2025 and subsequent payments of $14,007 due on October 30, 2025, November 30, 2025, December 30, 2025 and January 30, 2026.

On April 28, 2025, the Company entered into a securities purchase agreement with Quick Capital, LLC, a Wyoming limited liability company (the “Second Lender” ~~and together with the First Lender, the “Lenders”~~), an accredited investor, for the issuance and sale of a promissory note in the aggregate principal amount of $161,000 (the “April 2025 Promissory Note” ~~and together with the March 2025 Promissory Notes, the “Promissory Notes”~~) for a purchase price of $140,000 after deducting the original issue discount of $21,000. The April 2025 Promissory Note bears a one-time interest charge of twelve percent that was applied on the date of issuance, April 28, 2025. The April 2025 Promissory Note shall be paid in five payments with the first payment of $90,160 due on October 15, 2025 and subsequent payments of $22,540 due on November 15, 2025, December 15, 2025, January 15, 2026 and February 15, 2026.

1110

Table of Contents

On December 29. 2025, the Company entered into a securities purchase agreement with Vanquish Funding Group, Inc. (the “Third Lender” and together with the First Lender and Second Lender, the “Lenders”),, an accredited investor, for the issuance and sale of a promissory note in the aggregate principal amount of $38,500, which was funded on January 8, 2026 for a purchase price of $32,000 after deducting the original issue discount of $6,400. The Third Promissory Note bears a one-time interest charge of fifteen percent that was applied on the date of issuance, January 8, 2026. The Third Promissory Note shall be paid in four payments with the first payment of $22,080 due on June 30, 2026 and subsequent payments of $7,360 due on July 30, 2026, August 30, 2026, and September 30, 2026.

On January 2, 2026, the Company entered into a securities purchase agreement with the Second Lender. (together with the First Lender, Second Lender and Third Lender, the “Lenders”),, an accredited investor, for the issuance and sale of a promissory note in the aggregate principal amount of $38,500 (together with the December 29, 2025 promissory note, the “January 2026 Promissory Notes, and together with the March 2025 Promissory Notes and the April 2025 Promissory Notes, the “Promissory Notes”)), which was funded on January 8, 2026 for a purchase price of $32,000 after deducting the original issue discount of $6,400. The Promissory Note bears a one-time interest charge of fifteen percent that was applied on the date of issuance, January 8, 2026. The Promissory Note shall be paid in four payments with the first payment of $22,080 due on July 2, 2026 and subsequent payments of $7,360 due on August 2, 2026, September 2, 2026, and October 2, 2026.

Upon the occurrence and during any continuation of any Event of Default (as defined in the Promissory Notes), the Promissory Notes shall become immediately due and payable and, with respect to each Promissory note, the Company shall pay to the Lenders, in full satisfaction of such Promissory Note, an amount equal to 150% times the sum of (i) the then outstanding principal amount of such applicable Promissory Notes plus (ii) accrued and unpaid interest on the unpaid principal amount of such applicable Promissory Notes to the date of payment plus (iii) default interest, if any, at a rate of 22% per annum on the amounts referred to in clauses (i) and/or (ii) plus (iv) any amounts owed to the Lenders, as applicable, pursuant to the Conversion Right (as defined below). In addition, only upon an Event of Default and during any continuation thereof, the Lenders may elect to convert all or any part of the outstanding principal and interest on the Promissory Notes, as applicable, in fully paid and non-assessable shares of the Company’s common stock at a conversion price per share equal to 65% of the lowest closing bid price of the Company’s common stock for the ten trading days prior to the date of conversion (the “Conversion Right”). The Lenders, together with their affiliates, may not convert any portion of such Promissory Notes to the extent that the Lenders would own more than 4.99% of the Company’s outstanding common stock immediately after the conversion.

As of ~~September~~March 3031, ~~2025~~2026, the March 2025 ~~Promissory~~and April 2025 Promissory Notes were in default and became convertible under the default provisions. As a result, the Company incurred a default penalty of $.1 million. As such, The Company analyzed the conversion option for derivative accounting consideration under ASC 815, "Derivatives and Hedging," and determined that the convertible notes should be classified as a liability since the conversion option becomes effective at issuance resulting in there being no explicit limit to the number of shares to be delivered upon settlement of the above conversion options. The Company accounted for conversion feature of the March 2025 and April 2025 Promissory Notes as a derivative liability due to there being no explicit limit to the number of shares to be delivered upon settlement of all conversion options. The conversion features of the March 2025 and April 2025 Promissory Notes were recorded at fair value using the Black-Scholes valuation model. At ~~September~~March 3031, ~~2025~~2026, the Derivative liabilities related to the March 2025 and April 2025 Promissory Notes was $0.35 million.

7. Accrued Expense

As of ~~September~~March 3031, ~~2025~~2026, current liabilities included accrued expenses of $3.0 million, comprised primarily of accrued clinical trial expenses of $2.5 million, accrued salaries and benefits expense of $0.2 million and other accrued expenses of $0.3 million. As of December 31, 2024, current liabilities included accrued expenses of $1.9 million, comprised primarily of expenses related to the Company’s clinical trial for prexigebersen in AML of $1.5 million, accrued employee vacation of $0.1 million, professional and consulting fees of $0.1 million, legal and patent fees of $0.1 million and other accrued expenses of $0.1 million.

Table of Contents

8. Warrant Liability

In connection with the March 2024 Registered Direct Offering and the April 2024 Registered Direct Offering (each as defined in Note 10) and a 2023 public offering, the Company issued warrants under the March 2024 Private Placement and the April 2024 Private Placement (each as defined in Note 10) as well as the 2023 public offering (collectively, the “Warrants”). The Warrants contain a provision applicable in the event of a fundamental transaction whereby the volatility used to calculate the warrant exercise terms is fixed and meets the definition of a derivative.

Due to this provision and in accordance with Accounting Standard Codification (“ASC”) 815 Derivatives and Hedging, the Warrants were classified as a liability and recorded at fair value using the Black-Scholes valuation model. The estimated fair value of the warrant liability for the Warrants as of December 31, ~~2024~~2025, was $014,000.~~4 million.~~ As of ~~September~~March 3031, ~~2025~~2026, the fair value of the total warrant liability was $1112,000. The net change in fair value of $~~0.4 million~~2,000 is shown as other income on the Company’s Condensed Consolidated Statements of Operations. The Company will continue to measure the fair value of the Warrants each quarter until they are exercised or expire, and any change will be adjusted accordingly on the Company’s financial statements.

On October 24, 2025, the Company engaged Steel Giants Advisors LLC (“SGA”) to advise it on restructuring its’ operations, raise capital, and updating financial statements and maintaining books and records for a period of one year. As part of the engagement, the Company agreed to pay SGA $10,000 cash per month and issue SGA two million common stock purchase warrants with a cashless exercise price of $0.0001 and a five-year expiration

9. Fair Value Measurements

In accordance with ASC 820 Fair Value Measurement, the Company uses various inputs to measure the Warrants on a recurring basis to determine the fair value of the liability. ASC 820 also establishes a hierarchy categorizing inputs into three levels used to measure and disclose fair value. The hierarchy gives the highest priority to quoted prices available in active markets and the lowest priority to unobservable inputs. An explanation of each level in the hierarchy is described below:

Table of Contents

Level 1 – Unadjusted quoted prices in active markets for identical instruments that are accessible by the Company on the measurement date

Level 2 – Quoted prices in markets that are not active or inputs which are either directly or indirectly observable

Level 3 – Unobservable inputs for the instrument requiring the development of assumptions by the Company

The following table summarizes the Company’s Warrants measured at fair value within the hierarchy on a recurring basis as of ~~September~~March 3031, ~~2025~~2026:

	Fair Value Measurements at
	September 30, 2025
	March 31, 2026
	(In thousands)
	Level 1		Level 2		Level 3		Total
Liabilities:
Warrant liability	$	—	$	—	$	1112	$	1112
Derivative liability		—		—		~~343~~462		~~343~~462
	$	—	$	—	$	~~354~~474	$	~~354~~474

The following table summarizes the Company’s Warrants measured at fair value within the hierarchy on a recurring basis as of December 31, ~~2024~~2025:

	Fair Value Measurements at	~~Fair Value Measurements at~~
		December 31, 2024
	December 31, 2025
	(In thousands)	~~(In thousands)~~
	Level 1	~~Level 1~~	~~Level 2~~	Level 2		~~Level 3~~	Level 3		~~Total~~	Total
Liabilities:
Warrant liability	$	—	$	—$	—	$	~~434~~$	14	$	~~434~~$	14
Derivative liability		—			—			508			508
	$	—		$	—		$	522		$	522

~~The following table summarizes changes to the fair value of the Level 3 Warrants for the nine months ended September 30, 2025:~~12

	Fair Value of
	Warrant
	Liability
	(In thousands)
Balance at December 31, 2024	$	434
Change in fair value		(423	)
Balance at September 30, 2025	$	11

The following table summarizes changes to the fair value of the Level 3 Derivative liabilities for the nine months ended September 30, 2025:

	Fair Value of
	Warrant
	Liability
	(In thousands)
Balance at December 31, 2024	$	—
Change in fair value		343
Balance at September 30, 2025	$	343

Table of Contents

The following table summarizes changes to the fair value of the Level 3 Warrants for the three months ended March 31, 2026:

	Fair Value of
	Warrant
	Liability
	(In thousands)
Balance at December 31, 2025	$	14
Change in fair value		(2	)
Balance at March 31, 2026	$	12

The following table summarizes changes to the fair value of the Level 3 Derivative liabilities for the three months ended March 31, 2026:

	Fair Value of
	Warrant
	Liability
	(In thousands)
Balance at December 31, 2025	$	508
Change in fair value		(46	)
Balance at March 31, 2026	$	462

The Company utilized the Black-Scholes valuation model for estimating the fair value of the Warrants and Derivative liabilities using the following assumptions as of September 30, 2025:

	As of September 30, 2025
	As of March 31, 2026
Risk-free interest rate		3.92	%
Expected volatility		~~152 – 180~~138	%
Expected term in years		1- 3.9
Dividend yield		—	%

10. Stockholders’ Equity

Issuances of ~~Common~~Preferred Stock – On March 25, 2024, the Company entered into a securities purchase agreement with a certain institutional and accredited investor pursuant to which the Company agreed to sell, in a registered direct offering, an aggregate of 75,000 shares of its common stock for gross proceeds of approximately $0.3 million under the base prospectus contained in the 2022 Shelf Registration Statement (as defined below) and a related prospectus supplement filed with the SEC on March 27, 2024 (the “March 2024 Registered Direct Offering”). In a concurrent private placement, the Company also agreed, pursuant to the securities purchase agreement, to issue to such investor Warrants to purchase up to 75,000 shares of its common stock at an exercise price of $3.865 per share (the “March 2024 Private Placement”). The March 2024 Registered Direct Offering and the March 2024 Private Placement closed on March 27, 2024. The net proceeds from the offerings, after deducting the placement agent’s fees and expenses and the Company’s offering expenses, and excluding the proceeds, if any, from the exercise of the Warrants issued in the offerings, were approximately $0.2 million.

On ~~April~~January 42, ~~2024~~2026, the Company ~~entered~~created ~~into~~a ~~an At The~~new ~~Market~~class ~~Offering~~of ~~Agreement~~Series ~~the~~S ~~“At~~Preferred ~~The~~stock ~~Market Offering Agreement”)~~ with ~~H.C.~~51 ~~Wainwright~~authorized ~~& Co., LLC (Wainwright”), as sales agent, pursuant to which the Company may offer and sell, from time to time, through Wainwright,~~ shares ofeach ~~its~~having common stock. Under the At The Market Offering Agreement, Wainwright may sell shares by any method deemed to be an “at the market” offering as defined in Rule 415 under the Securities Act, as amended, or any other method permitted by law, including in privately negotiated transactions. The Company or Wainwright may suspend or terminate the offering of shares upon notice to the other party and subject to other conditions. The Company will pay Wainwright a commission of 3.01% of the ~~aggregate~~fully ~~gross~~diluted ~~proceeds~~voting ~~from~~power ~~each sale~~ of ~~shares under~~ the Atcompany ~~The Market Offering Agreement~~ and ~~have agreed to provide Wainwright with customary indemnification and contribution~~convertible ~~rights.~~into ~~The~~one ~~Company has also agreed to reimburse Wainwright for certain specified expenses. The Company is subject to certain restrictions on its ability to offer and sell shares of its~~ common ~~stock under the At The Market Offering Agreement~~share. On ~~April~~January 43, ~~2024~~2026, ~~in connection with~~ the ~~execution of the At The Market Offering Agreement, the~~ Company ~~filed~~issued ~~with~~51 the SEC a prospectus supplement (the “Initial ATM Prospectus Supplement”) to the base prospectus contained in the 2022 Shelf Registration Statement, which Initial ATM Prospectus Supplement related to the offering of up to $2.0 million of shares of ~~the~~Series ~~Company’s common~~S Preferred stock ~~under~~to ~~the At~~Steel ~~The~~Giants ~~Market~~Advisors ~~Offering~~LLC ~~Agreement. Subsequent~~ to ~~entering into the At The Market Offering Agreement,~~facilitate ~~the~~restructuring ~~Company offered and sold 436,511 shares~~ of ~~common~~its’ ~~stock~~financial ~~for~~obligations ~~gross proceeds of approximately $2.0 million~~ and ~~terminated the~~manage ~~offering~~its’ ~~under~~current ~~the Initial ATM Prospectus Supplement on April 19, 2024. The net proceeds from such offering, after deducting commissions~~ and ~~its~~planned ~~offering~~corporate ~~expenses, were approximately $1~~actions.8 ~~million.~~

OnIssuances April 18, 2024, the Company entered into a securities purchase agreement with certain institutional and accredited investors pursuant to which the Company agreed to sell, in a registered direct offering, an aggregate of ~~375,000 shares~~ ofCommon ~~its~~Stock ~~common stock for gross proceeds of approximately $1.2~~– million under the base prospectus contained in the 2022 Shelf Registration Statement and a related prospectus supplement filed with the SEC on April 19, 2024 (the “April 2024 Registered Direct Offering”). In a concurrent private placement, the Company also agreed, pursuant to the securities purchase agreement to issue to such investors Warrants to purchase up to 375,000 shares of its common stock at an exercise price of $3.10 per share (the “April 2024 Private Placement”). The April 2024 Registered Direct Offering and the April 2024 Private Placement closed on April 19, 2024. The net proceeds from the offerings, after deducting the placement agent’s fees and expenses and the Company’s offering expenses, and excluding the proceeds, if any, from the exercise of the Warrants issued in the offerings, were approximately $0.9 million.

14On January 24, 2026 the Company engaged Farrington Capital Group, Inc. to enhance its online and technological platforms, make introductions to strategic advisors, and review operations. As compensation, Farrington Capital Group received $1,000 in cash and 100,000 restricted common shares.

On February 10, 2026, the Company created a Scientific Advisory Board to guide the Company through its planned restarts of clinical trials for treatments and cures for AML, solid cancer tumors, and other rare diseases. To support this effort, the Company approved the issuance of up to 1.5 million stock options to be issued at or above market prices over the next three years. The made bonafide offers to four professionals with significant experience in the medical research, academia and business fields. These candidates need their respective employers’ approval to join our Advisory Board. At this time, three individuals: 1) Wendy Charles , PhD, a digital health scientist and Global Speaker University of Colorado Anschutz Medical Campus, 2) Michael Hickey, V.P. of Clinical Operations to Processa Pharmaceuticals and the former V.P. of Clinical Operations, and 3) Rick Silva, PhD, a biomedical research professional with expertise in large research collaborations, consortia, R&D alliances, IP asset portfolio management, medical product development partnerships, venture development, and seed funding, have accepted and been appointed to the Scientific Advisory Board. They were each issued one hundred thousand common stock purchase warrants with a three-year term, $0.03 exercise price, and cashless exercise feature. Other candidates’ offers are pending reviews by their advisors and respective employers.

Table of Contents

OnDuring ~~April 19, 2024,~~ the ~~Company~~quarter ~~determined~~ended toMarch ~~increase the~~31, ~~number~~2025, ~~of shares available for sale under~~ the Company Atissued ~~The Market Offering Agreement, up to~~ an ~~additional~~ aggregate ~~offering price~~ of ~~approximately $1.1~~ ~~million~~2, ~~which~~ 540,000 shares ~~are~~of ~~being~~its ~~offered~~common ~~and~~stock ~~sold~~ pursuant to the ~~2022~~exercise ~~Shelf~~of ~~Registration~~pre-funded ~~Statement~~warrants ~~and~~at a ~~prospectus supplement~~weighted ~~and~~average ~~accompanying~~exercise ~~prospectus~~price ~~filed~~of ~~with~~approximately ~~the~~$0.001 per ~~SEC on April 19, 2024 (the “Subsequent ATM Prospectus Supplement”)~~share. AsThe ~~of June 30, 2024, the~~ Company ~~has~~did ~~offered~~not ~~and~~issue ~~sold 334,929 shares~~any of common stock ~~under~~pursuant to the ~~Subsequent~~exercise ~~ATM Prospectus Supplement for~~of ~~gross~~warrants ~~proceeds~~during ofthe ~~approximately~~year ~~$1.1 million.~~ended ~~The~~December ~~net proceeds from such offering~~31, ~~after deducting commissions and the Company’s offering expenses, were approximately $1~~2024.~~0 million.~~

OnStockholders’ June 3, 2024, the Company entered into a securities purchase agreement with a certain institutional and accredited investor pursuant to which the Company agreed to sell, in a private placement, an aggregate of (iDeficit) ~~180,000 shares~~ ofEquity ~~its common stock,~~ totaled (ii$8.5) ~~pre-funded~~million ~~warrants~~as toof ~~purchase~~March ~~up to 1~~31,~~629,955 shares of~~ ~~its~~2026 ~~common~~compared ~~stock~~to ~~at an exercise price of~~ $0(8.~~001~~2) ~~per~~million ~~share,~~as ~~(iii)~~of ~~series~~December A31, ~~warrants~~2025. toThere ~~purchase up to~~were 19,~~809~~342,~~955~~342 shares of ~~its~~ of common stock ~~at an exercise price of $2.00~~ ~~per share~~ issued and ~~(iv) series B warrants to purchase up to~~ ~~1,809,955~~outstanding ~~shares~~ as of ~~its~~March ~~common~~31, ~~stock~~2026 atand ~~an exercise price of $2.00~~51 ~~per~~shares ~~share for gross proceeds~~ of ~~approximately~~Series ~~$4.0~~S ~~million~~preferred ~~(the~~stock ~~“June~~issued ~~2024~~and ~~PIPE”).~~outstanding ~~The~~as June 2024 PIPE closed on June 5, 2024. The net proceeds from the offering, after deducting the placement agent’s fees and expenses and the Company’s offering expenses, and excluding the proceeds, if any, from the exercises of ~~the~~March ~~warrants issued in the offering~~31, ~~were approximately $3~~2026.~~3 million.~~

On October 8, 2024, the Company entered into a securities purchase agreement with a certain institutional and accredited investor pursuant to which the Company agreed to sell, in a private placement, an aggregate of (i) pre-funded warrants to purchase up to 4,597,702 shares of its common stock at an exercise price of $0.001 per share, (ii) series A warrants to purchase up to 6,407,657 shares of its common stock at an exercise price of $1.00 per share and (iii) series B warrants to purchase up to 6,407,657 shares of its common stock at an exercise price of $1.00 per share for gross proceeds of approximately $4.0 million (the “October 2024 Private Placement”). The October 2024 Private Placement closed on October 10, 2024 (the “Closing Date”). In connection with the October 2024 Private Placement, the Company and the investor agreed to cancel such investor’s series A warrants to purchase 1,809,955 shares of common stock at an exercise price of $2.00 and series B warrants to purchase 1,809,955 shares of common stock at an exercise price of $2.00 issued to such investor in connection with the June 2024 Private Placement, effective as of the Closing Date. The net proceeds from the offering, after deducting the placement agent’s fees and expenses and the Company’s offering expenses, and excluding the proceeds, if any, from the exercises of the warrants issued in the offering, were approximately $3.5 million.

During the nine months ended September 30, 2025, the Company issued an aggregate of 2,540,000 shares of its common stock pursuant to the exercise of pre-funded warrants at a weighted average exercise price of approximately $0.001 per share. The Company did not issue any common stock pursuant to the exercise of warrants during the year ended December 31, 2024.

During the nine months ended September 30, 2025, convertible debt of $0.1 million was converted into 1,395,000 shares of common stock, of which 461,000 shares have yet to be issued.

Stockholders’ (Deficit) Equity totaled ($7.9) million as of September 30, 2025 compared to $0.2 million as of December 31, 2024. There were 9,242,151 shares of common stock issued and outstanding as of September 30, 2025. There were no shares of preferred stock issued and outstanding as of September 30, 2025.

11. Stock-Based Compensation Plan

The 2022 Plan – On December 15, 2022, the Company’s stockholders approved the Bio-Path Holdings, Inc. 2022 Stock Incentive Plan (the “2022 Plan”), which replaced the 2017 Stock Incentive Plan, as amended (the “2017 Plan,” and together with the 2022 Plan, the “Plans”). As of stockholder approval of the 2022 Plan on December 15, 2022, no further awards will be made under the 2017 Plan. The 2022 Plan provides for the grant of Incentive Stock Options, Non-Qualified Stock Options, Restricted Shares, Restricted Share Units, Stock Appreciation Rights and other stock-based awards, or any combination of the foregoing, to the Company’s employees, non-employee directors and consultants. As of December 31, 2024, there were 1,200,948 shares of common stock reserved for future issuance of awards under the 2022 Plan. Under the 2022 Plan, the exercise price of awards is determined by the Board of Directors or the compensation committee of the Board of Directors, and for options, may not be less than the fair market value as determined by the closing stock price at the date of the grant. Each option and award under the 2022 Plan shall vest and expire as determined by the Board of Directors or the compensation committee. Options expire no later than ten years from the date of grant. All grants provide for accelerated vesting if there is a change in control, as defined in the 2022 Plan.

15Stock-based compensation expense for the three months ended September 30, 2025 and 2024 was $27,000 and $0.1 million, respectively. Of these amounts, stock-based compensation expense for personnel involved in the Company’s general and administrative activities for each of the three months ended June 30, 2025 and 2024 was $14,000 and $0.1 million, respectively. Stock-based compensation expense for personnel involved in the Company’s research and development activities for the three months ended March 31, 2026 and 2025 was $0 and $32,000, respectively.

The Company utilized the Black-Scholes valuation model for estimating the fair value of the stock options granted. There were no options granted in the three months ended March 31, 2026 and 2025.

The following summary represents option activity under the Company’s stock-based compensation plans for the three months ended March 31, 2026:

			Weighted-
			Average
			Exercise
	Options		Price
	(In thousands)
Outstanding at December 31, 2025		60	$	107.50
Forfeited		—		—
Outstanding at March 31, 2026		60	$	107.50
Vested and expected to vest March 31, 2026		60	$	108.18
Exercisable at March 31, 2026		42	$	150.44

As of March 31, 2026, outstanding stock options did not have any aggregate intrinsic value. The aggregate intrinsic value represents the total pretax intrinsic value (the difference between the Company’s closing stock price on March 31, 2026 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders had all option holders exercised their options on September 30, 2025. This amount changes based on the fair value of the Company’s stock.

Table of Contents

Stock-based compensation expense for the three months ended September 30, 2025 and 2024 was $27,000 and $0.1 million, respectively. Of these amounts, stock-based compensation expense for personnel involved in the Company’s general and administrative activities for each of the three months ended June 30, 2025 and 2024 was $14,000 and $0.1 million, respectively. Stock-based compensation expense for personnel involved in the Company’s research and development activities for the three months ended September 30, 2025 and 2024 was $14,000 and $40,000, respectively.

Stock-based compensation expense for the nine months ended September 30, 2025 and 2024 was $0.2 million and $0.3 million, respectively. Of these amounts, stock-based compensation expense for personnel involved in the Company’s general and administrative activities for each of the nine months ended September 30, 2025 and 2024 was $0.1 million and $0.2 million, respectively. Stock-based compensation expense for personnel involved in the Company’s research and development activities for the nine months ended September 30, 2025 and 2024 was $0.1 million and $0.1 million, respectively.

The Company utilized the Black-Scholes valuation model for estimating the fair value of the stock options granted. There were no options granted in the nine months ended September 30, 2025 and 2024.

The following summary represents option activity under the Company’s stock-based compensation plans for the nine months ended September 30, 2025:

		Weighted-
		Average
		Exercise
	Options	Price
	(In thousands)
Outstanding at December 31, 2024	96	$	71.40
Forfeited	(36)		5.99
Outstanding at September 30, 2025	60	$	107.50
Vested and expected to vest September 30, 2025	60	$	108.18
Exercisable at September 30, 2025	42	$	150.44

As of September 30, 2025, outstanding stock options did not have any aggregate intrinsic value. The aggregate intrinsic value represents the total pretax intrinsic value (the difference between the Company’s closing stock price on September 30, 2025 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders had all option holders exercised their options on September 30, 2025. This amount changes based on the fair value of the Company’s stock.

As of September 30, 2025, unamortized stock-based compensation expense for all outstanding options was $0.2 million, which is expected to be recognized over a weighted average vesting period of 1.4 years.

12. Commitments and Contingencies

Drug Supplier Project Plan – Total commitments for the Company’s drug supplier project plan were $0.1 million as of ~~September~~March 3031, ~~2025~~2026, comprised of $0.1 million for testing services. The Company expects to incur $0.1 million of these commitments over the next 12 months.

Table of Contents

13. Subsequent Events

On ~~October~~April 2230, ~~2025~~2026, ~~the~~we ~~Board~~sold of466,100 ~~Directors (the~~shares ~~“Board”)~~to ofa ~~the~~third-party investor ~~Company~~raising ~~elected~~proceeds ~~and~~of ~~appointed Vikram Grover as President~~$13,983 ~~Chief~~under ~~Executive~~our ~~Officer,~~active ~~Chief~~Tier ~~Financial~~1 ~~Officer, and~~Regulation ~~member~~A ~~of the Board~~offering.

On ~~October~~May 228, ~~2025~~2026, ~~the~~we ~~Board~~retained ofGT ~~the~~Securities, ~~Company~~a registered ~~accepted~~broker-dealer ~~the~~and ~~resignation~~member ofFINRA/SIPC, ~~Douglas~~to ~~Morris~~provide asfinancial ~~Interim~~advisory ~~Chief~~services ~~Executive~~in ~~Officer~~connection ~~and~~with ~~Interim~~the ~~Chief~~evaluation ~~Financial~~of ~~Officer.~~potential financing alternatives, strategic partnerships, licensing

Onopportunities, ~~October~~and ~~22,~~other ~~2025,~~corporate ~~the~~transactions. ~~Board~~GT Securities ofmay also assist the Company ~~accepted~~ ~~the~~in ~~resignation~~identifying ofand ~~Paul~~introducing ~~Aubert~~qualified asstrategic ~~Director~~and institutional counterparties, subject to applicable securities laws and regulations.

On ~~October~~May 2413, ~~2025~~2026, ~~the~~we ~~Company~~sold ~~engaged~~489,200 ~~Steel Giants~~shares ~~Advisors LLC (“SGA”)~~ to ~~advise~~a ~~it on restructuring its’ operations, raise capital, and updating financial statements~~third-party ~~and~~investor ~~maintaining~~raising ~~books~~proceeds ~~and records for a period~~ of ~~one year. As part of the engagement, the Company agreed to pay SGA~~ $1014,~~000~~676 ~~cash~~under ~~per month~~our ~~and~~active ~~issue~~Tier ~~SGA~~1 ~~two~~Regulation ~~million~~A ~~common stock purchase warrants with a cashless exercise price of $0~~offering.~~0001 and a five-year expiration.~~

On ~~November~~May 1315, ~~2025~~2026, ~~the~~we ~~Board~~issued ofSteel ~~the~~Giants ~~Company~~Advisors ~~accepted~~LLC ~~the~~40,000,000 ~~resignation~~common ofshares ~~Douglas~~for ~~Morris~~accrued ascompensation ~~member~~under ofa ~~the~~consulting ~~Board~~agreement ofand ~~Directors~~for ~~which~~wages ~~was~~due ~~provided electronically~~ to usour onCEO, ~~November~~Vikram ~~4, 2025~~Grover.

~~Subsequent to September 30, 2025, the Company defaulted on the April 2025 Promissory Note.~~15

On January 2, 2026, we issued Steel Giants Advisors LLC two million common stock purchase warrants with a cashless exercise price of $0.0001 and a five-year expiration under a previously signed advisory agreement

On January 2, 2025, we created a new class of Series S Preferred stock with 51 authorized shares each having 1% of the fully diluted voting power of the corporation and convertible into one common share. On January 3, 2026, we issued 51 shares of Series S Preferred stock to Steel Giants Advisors LLC to facilitate restructuring of our financial obligations and manage our current and planned corporate actions including domestication of our corporation in Wyoming.

On January 8, 2026, the Company entered into a securities purchase agreement with the First Lender, an accredited investor, for the issuance and sale of a promissory note in the aggregate principal amount of $38,400 for a purchase price of $32,000 after deducting the original issue discount of $7,000. The Promissory Note bears a one-time interest charge of fifteen percent that was applied on the date of issuance, The Promissory Note shall be paid in five payments with the first payment of $22,080 due on June 30 2026 and subsequent payments of $7,360 due on July 30, 2026, August 30, 2026, and September 30, 2026.

On January 8, 2026, the Company entered into a securities purchase agreement with the Second Lender, an accredited investor, for the issuance and sale of a promissory note in the aggregate principal amount of $38,400 for a purchase price of $32,000 after deducting the original issue discount of $7,000. The Promissory Note bears a one-time interest charge of fifteen percent that was applied on the date of issuance, The Promissory Note shall be paid in five payments with the first payment of $22,080 due on June 30, 2026, and subsequent payments of $7,360 due on July 30, 2026, August 30, 2026, and September 30, 2026.

Table of Contents

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

When you read this Item of this Quarterly Report on Form 10-Q, it is important that you also read the unaudited financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and our ~~audited~~ financial statements and notes thereto included in our Annual Report on Form 101-K as of the fiscal year ended December 31, ~~2024~~2025. This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions. We use words such as “anticipate,” “estimate,” “plan,” “project,” “continuing,” “ongoing,” “expect,” “believe,” “intend,” “may,” “will,” “should,” “could,” and similar expressions to identify forward-looking statements. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including the matters discussed in “Item 1A. Risk Factors” to Part I of our Annual Report on Form 101-K as of the fiscal year ended December 31, ~~2024~~2025, the matters discussed in “Item 1A. Risk Factors” to Part II of this Quarterly Report on Form 10-Q and other risks and uncertainties discussed in filings made with the SEC. See “Cautionary Note Regarding Forward-Looking Statements” in this Quarterly Report on Form 10-Q for additional discussion regarding risks associated with forward-looking statements.

Overview

We are a clinical and preclinical stage oncology and obesity-focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target-specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology, called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction by the body’s enzymes when circulating in vivo, incorporated inside of a lipid bilayer having neutral charge. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, the DNAbilize® delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. Through testing in numerous animal studies and dosing in clinical trials, our DNAbilize® drug candidates have demonstrated an excellent safety profile. DNAbilize® is a registered trademark of the Company.

Using DNAbilize® as a platform for drug development and manufacturing, we currently have four drug candidates in development to treat at least five different cancer disease indications and one indication in obesity. Our lead drug candidate, BP1001, or “prexigebersen” (pronounced prex” i je ber’ sen), which is being developed to target growth factor receptor-bound protein 2 (“Grb2”), initially started the efficacy portion of a Phase 2 clinical trial for untreated acute myeloid leukemia (“AML”) patients in combination with low-dose cytarabine (“LDAC”). However, the changing landscape of AML treatment led to the amendment of the Phase 2 clinical study by removing the combination treatment of prexigebersen and LDAC and replacing it with the combination treatment of prexigebersen and decitabine.

In October 2020, the U.S. Food and Drug Administration (“FDA”) granted approval of venetoclax in combination with LDAC, decitabine or azacytidine (the latter two drugs are DNA hypomethylating agents) as frontline therapy for newly diagnosed AML in adults who are 75 years or older, or who have comorbidities precluding intensive induction chemotherapy. We believe this approval of the frontline venetoclax and decitabine combination therapy provides an opportunity for developing prexigebersen as an addition to the combination therapy for the treatment of newly diagnosed AML patients. In preclinical efficacy studies, four AML cancer cell lines were treated with three different combinations of decitabine, venetoclax and prexigebersen. Decrease in AML cell viability was the primary measure of efficacy. The triple combination of decitabine, venetoclax and prexigebersen showed significant improvement in efficacy in three of the four AML cell lines. Based on these results, we believe that adding prexigebersen to the treatment combination of decitabine and venetoclax could lead to improved efficacy in AML patients.

Our approved amended Phase 2 clinical trial currently has three cohorts of subjects. The first two cohorts treat patients with the triple combination of prexigebersen, decitabine and venetoclax. The first cohort includes newly diagnosed AML patients while the second cohort includes relapsed/refractory AML patients. The third cohort treats relapsed/refractory AML patients who are venetoclax-resistant or -intolerant with the two-drug combination of prexigebersen and decitabine. The full trial design plans have approximately 98 evaluable patients for the first cohort having newly diagnosed AML patients with a preliminary review performed after 19 evaluable patients and a formal interim analysis after 38 evaluable patients. The full trial design plans have approximately 54 evaluable patients for each of the second cohort, having relapsed/refractory AML patients, and the third cohort, having AML patients who are venetoclax-resistant or -intolerant, in each case with a review performed after 19 evaluable patients. The study is anticipated to be conducted at up to ten clinical sites in the U.S., and Gail J. Roboz, MD, is the national coordinating Principal Investigator for the Phase 2 trial. Dr. Roboz is a professor of medicine and director of the Clinical and Translational Leukemia Program at the Weill Medical College of Cornell University (the “Weill Medical College”) and the New York-Presbyterian Hospital in New York City.

1816

Table of Contents

The safety run-in of the triple combination of prexigebersen, decitabine and venetoclax for the Phase 2 clinical study was successfully completed. The preliminary data, presented at the 2021 ASH Annual Meeting, showed the treatment was well-tolerated and there were no dose limiting toxicities attributed to prexigebersen.

On June 3, 2024, we announced additional interim data for the first two cohorts of the Phase 2 clinical trial. In Cohort 1, 31 newly diagnosed patients were enrolled; 20 evaluable patients with a median age of 75 years, treated with at least one cycle of prexigebersen, decitabine and venetoclax, had adverse-risk or secondary AML evolved from myelodysplastic syndromes, chronic myelomonocytic leukemia or treatment-related AML. Fifteen patients (75%) achieved complete remission (“CR”), CR with partial recovery of peripheral blood counts (“CRh”), or CR with incomplete hematologic recovery (“CRi”). One patient achieved partial remission (“PR”), three patients achieved stable disease, and one patient had toxicity attributed to decitabine and venetoclax treatment. In Cohort 2, 40 relapsed/refractory patients were enrolled; 23 evaluable patients with a median age of 63 years, treated with at least one cycle of prexigebersen, decitabine and venetoclax, had adverse-risk or secondary AML. Twelve patients (55%) achieved CR/CRi/ CRh, one patient achieved PR, eight patients achieved stable disease and two patients had progressive disease or treatment failure. Among the evaluable patients of both cohorts, adverse events were consistent with those expected with decitabine and venetoclax and/or AML, including fatigue (72%), anemia (60%) and neutropenia (49%), while the most frequent severe adverse events were febrile neutropenia (26%) and sepsis (5%). The interim analysis data was selected as an oral presentation in the 2024 American Society of Clinical Oncology (“ASCO”) Annual Meeting and as a poster presentation in the 2024 European Hematology Association (“EHA”) Annual Meeting.

Our second drug candidate, Liposomal Bcl-2 (“BP1002”), targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. A Phase 1 clinical trial to evaluate the ability of BP1002 to treat refractory/relapsed lymphoma and refractory/relapsed chronic lymphocytic leukemia (“CLL”) patients was being conducted at the Georgia Cancer Center, The University of Texas Southwestern and New York Medical College. On December 11, 2024, we announced that the Phase 1 clinical trial was discontinuing enrollment based on enrollment challenges in these niche indications, particularly given the crowded development landscape that includes multiple competing trials. Furthermore, reducing this development program allows us the ability to increase our focus on the initiation of our obesity development program.

Additionally, preclinical studies suggest that the combination of BP1002 with decitabine is efficacious in venetoclax-resistant cells. An abstract of the preclinical study was presented at the 2021 American Association for Cancer Research (“AACR”) Annual Meeting. A Phase 1/1b clinical trial to investigate the ability of BP1002 to treat refractory/relapsed AML patients, including venetoclax-resistant patients, is being studied. A recent study found that AML patients who had relapsed from frontline venetoclax-based treatment had a very poor prognosis, with a median survival of less than three months. Since venetoclax and BP1002 utilize different mechanisms of action, we believe that BP1002 may be a potential treatment for venetoclax-relapsed AML patients. The Phase 1/1b clinical trial is being conducted at several leading cancer centers in the United States, including the Weill Medical College, The University of Texas MD Anderson Cancer Center (“MD Anderson”), Scripps Health and The University of California at Los Angeles Cancer Center. On October 7, 2024, we announced that the FDA had completed its review of PK/PD data from the first two dosing cohorts (20 and 40 mg/m²) and that enrollment for the third dosing cohort (60 mg/ m²) was complete.

Our third drug candidate, Liposomal STAT3 (“BP1003”), targets the STAT3 protein and is currently in IND enabling studies as a potential treatment of pancreatic cancer, non-small cell lung cancer (“NSCLC”) and AML. Preclinical studies showing BP1003’s ability to inhibit STAT3 protein expression and cancer cell viability had been presented at AACR Annual Meetings. On September 16, 2024, we announced a publication in the peer-reviewed journal, Biomedicines, which highlights the therapeutic potential and broad anti-tumor effect of BP1003 in numerous preclinical solid tumor models, including breast, ovarian, and pancreatic cancer. The lead indication for which we intend to develop BP1003 is pancreatic cancer due to the severity of this disease and the lack of effective, life-extending treatments. For example, pancreatic adenocarcinoma is projected to be the second most lethal cancer behind lung cancer by 2030. Typical survival for a metastatic pancreatic cancer patient is about three to six months from diagnosis. We have successfully completed several IND enabling studies of BP1003 and have one additional IND enabling study to complete.

In addition, a modified product named BP1001-A, our fourth drug candidate, has shown to enhance chemotherapy efficacy in a preclinical study involving solid tumor models. Results of the preclinical study were published in the scientific journal Oncotarget in July 2020. BP1001-A incorporates the same drug substance as prexigebersen but has a slightly modified formulation designed to enhance nanoparticle properties. A BP1001-A Phase 1/1b clinical trial in patients with advanced or recurrent solid tumors is being conducted at several leading cancer centers in the United States, including Karmanos Cancer Institute, Mary Crowley Cancer Research and Holy Cross Hospital, Maryland. On July 17, 2023, we announced completion of the first cohort of the dose escalation portion of the Phase 1/1b clinical trial. A total of nine evaluable patients are scheduled to be treated with BP1001-A monotherapy over three dose levels in a standard 3+3 dose escalation design. The first dose cohort consisted of a starting dose of 60 mg/m2, and there were no dose limiting toxicities.

Table of Contents

In addition, a modified product named BP1001-A, our fourth drug candidate, has shown to enhance chemotherapy efficacy in a preclinical study involving solid tumor models. Results of the preclinical study were published in the scientific journal Oncotarget in July 2020. BP1001-A incorporates the same drug substance as prexigebersen but has a slightly modified formulation designed to enhance nanoparticle properties. A BP1001-A Phase 1/1b clinical trial in patients with advanced or recurrent solid tumors is being conducted at several leading cancer centers in the United States, including Karmanos Cancer Institute, Mary Crowley Cancer Research and Holy Cross Hospital, Maryland. On July 17, 2023, we announced completion of the first cohort of the dose escalation portion of the Phase 1/1b clinical trial. A total of nine evaluable patients are scheduled to be treated with BP1001-A monotherapy over three dose levels in a standard 3+3 dose escalation design. The first dose cohort consisted of a starting dose of 60 mg/m², and there were no dose limiting toxicities.

Development and Treatment for Obesity

Insulin resistance is a major contributor to obesity, Type 2 diabetes and other related metabolic diseases. Insulin lowers blood glucose level by activating the phosphoinositol-3 kinase (PI3K)/AKT pathway. However, this insulin pathway is dysfunctional in obese patients who have Type 2 diabetes. Literature suggests that Grb2 is an inhibitor of the insulin/PI3K/AKT pathway. Upregulation of the Grb2 gene has been reported for patients with Type 2 diabetes. Knockdown of Grb2 expression enhanced insulin-induced AKT activity and glucose uptake in myoblast and hepatoma cells. Furthermore, insulin sensitivity was restored in Grb2 heterozygous knockout mice fed on high fat-induced diet.

On December 19, 2024, we announced the results of our initial preclinical work; BP1001-A, by downregulating Grb2 expression, increased the levels of phosphorylated AKT and phosphorylated FOXO-1 (a downstream AKT effector) in myoblast and hepatoma cells in the presence of insulin. Furthermore, a high fat diet rich in saturated fatty acids can lead to insulin resistance. Palmitic acid, the most common saturated fatty acid in a high fat diet, has been shown to impair insulin signaling. On March 18, 2025, we announced preclinical results that BP1001-A attenuated fatty acid-induced insulin resistance and restored insulin sensitivity in muscle progenitor and skeletal muscle fiber cell models. These preliminary data confirmed that BP1001-A could affect the insulin/PI3K/AKT pathway and increase insulin sensitivity, thus validating BP1001-A as a potential candidate to target obesity in Type 2 diabetes patients.

On May 1, 2025, we announced the achievement of a third milestone from preclinical studies of BP1001-A that provide additional support for its potential as a treatment for obesity. These studies showed BP1001-A rescues the decrease in AKT activity in liver cells and prevents cells from becoming insulin resistant, confirming its potential as a treatment for obesity and related metabolic diseases in Type 2 diabetes patients. Preliminary results indicated HepG2 cells with BP1001-A restored insulin signaling in HepG2 cells treated with palmitic acid. This data showed that BP1001-A could potentially help skeletal and liver cells from becoming insulin resistant and BP1001-A is a potential treatment for obese patients who have Type 2 diabetes.

Our DNAbilize® technology-based products are available for out-licensing or partnering. We intend to apply our drug technology template to new disease-causing protein targets to develop new liposomal antisense drug candidates for inclusion in our pipeline that meet scientific, preclinical and commercial criteria and file new patents on these targets. We expect that these efforts will include collaboration with key scientific opinion leaders in the field of study and include developing drug candidates for diseases other than cancer. As we expand our drug development programs, we will look at indications where a systemic delivery is needed and antisense RNAi nanoparticles can be used to slow, reverse or cure a disease, either alone or in combination with another drug.

We are developing a molecular biomarker package to accompany prexigebersen treatment, the goal of which is to identify patients with a genetic profile more likely to respond to the investigational treatment and improve the probability of success for this program as a result. The emerging role of biomarkers has been enhancing cancer development over the past decade and has become a more common companion to many cancer development programs.

We have certain intellectual property as the basis for our current drug products in clinical development, prexigebersen, BP1002, BP1003 and BP1001-A. We are developing RNAi antisense nanoparticle drug candidates based on our own patented technology to treat cancer, obesity and related metabolic diseases, and autoimmune disorders where targeting a single protein may be advantageous and result in reduced patient adverse effects as compared to small molecule inhibitors with off-target and non-specific effects. We have composition of matter and method of use intellectual property for the design and manufacture of antisense RNAi nanoparticle drug products.

On June 24, 2025, the Company announced that it instituted a Company-wide operational pause in order to conserve capital. The Company has furloughed most of its employees and paused most of its operations until further notice while the Company continues to seek financing or additional capital. The Board is currently discussing and evaluating a course of action in light of the Company’s limited capital resources, such operational pause and the resignations of Peter H. Nielsen, Heath Cleaver and Aline Sherwood.18

Table of Contents

AsOn ofJune ~~September 30~~24, 2025, we ~~had an accumulated deficit of $126.0 million. Our net loss was $1.0 million and $2.1 million for~~ the ~~three~~Company ~~months~~announced ~~ended~~that ~~September~~it ~~30,~~instituted ~~2025~~a ~~and~~Company-wide ~~2024,~~operational ~~respectively.~~pause ~~Our~~in ~~net~~order ~~loss was $8.4 million and $7.1 million for the nine months ended September 30, 2025 and 2024, respectively. We expect~~ to ~~continue~~conserve ~~to incur significant operating losses, and we anticipate that our losses may increase substantially as we expand our drug development programs and commercialization efforts~~capital. ToThe ~~achieve~~Company ~~profitability,~~has wefurloughed ~~must~~most ~~enter~~of ~~into~~its ~~license~~employees ~~or development agreements with third parties or successfully develop~~ and ~~obtain~~paused ~~regulatory~~most ~~approval for one or more~~ of ~~our drug candidates and effectively commercialize~~its ~~any~~operations ~~drug~~until ~~candidates~~further wenotice ~~develop.~~while Inthe ~~addition,~~Company ifcontinues weto ~~obtain~~seek ~~regulatory~~financing ~~approval of one~~ or ~~more~~additional ofcapital. ~~our~~The ~~drug~~Board ~~candidates,~~is wecurrently ~~expect to incur~~discussing ~~significant commercialization expenses related to product sales, marketing, manufacturing~~ and ~~distribution.~~evaluating ~~Even~~a ifcourse weof ~~succeed~~action in ~~developing and~~light ~~commercializing one or more~~ of ~~our~~the ~~drug~~Company’s ~~candidates,~~limited wecapital ~~may not be able to generate sufficient revenue and we may never be able to achieve or sustain profitability. We expect to finance our foreseeable cash requirements through cash on hand~~resources, ~~cash~~such ~~from~~operational ~~operations,~~pause ~~debt financings~~ and ~~public or private equity offerings. We may seek to access~~ the ~~public or private equity markets whenever conditions are~~resignations ~~favorable;~~of ~~however,~~Peter ~~there can be no assurance that we will be able to raise additional capital when needed or on terms that are favorable to us, if at all~~H. ~~Additionally~~Nielsen, weHeath ~~may~~Cleaver ~~seek collaborations~~ and ~~license~~Aline ~~arrangements for our drug candidates~~Sherwood. ~~We currently have no lines of credit or other arranged access to debt financing.~~

As of March 31, 2026, we had an accumulated deficit of $126.0 million. Our net loss was $1.0 million and $2.1 million for the three months ended March 31, 2026 and 2025, respectively. We expect to continue to incur significant operating losses, and we anticipate that our losses may increase substantially as we expand our drug development programs and commercialization efforts. To achieve profitability, we must enter into license or development agreements with third parties or successfully develop and obtain regulatory approval for one or more of our drug candidates and effectively commercialize any drug candidates we develop. In addition, if we obtain regulatory approval of one or more of our drug candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Even if we succeed in developing and commercializing one or more of our drug candidates, we may not be able to generate sufficient revenue and we may never be able to achieve or sustain profitability. We expect to finance our foreseeable cash requirements through cash on hand, cash from operations, debt financings and public or private equity offerings. We may seek to access the public or private equity markets whenever conditions are favorable; however, there can be no assurance that we will be able to raise additional capital when needed or on terms that are favorable to us, if at all. Additionally, we may seek collaborations and license arrangements for our drug candidates. We currently have no lines of credit or other arranged access to debt financing.

Company History and Available Information

The Company was incorporated in May 2000 as a Utah corporation. In February 2008, Bio-Path Subsidiary completed a reverse merger with the Company, which at the time was traded over the counter and had no current operations. The prior name of the Company was changed to Bio-Path Holdings, Inc. and the directors and officers of Bio-Path Subsidiary became the directors and officers of Bio-Path Holdings, Inc. On March 10, 2014, our common stock ceased trading on the OTCQX and commenced trading on the Nasdaq Capital Market under the ticker symbol “BPTH.” Effective December 31, 2014, we changed our state of incorporation from Utah to Delaware through a statutory conversion pursuant to the Utah Revised Business Corporation Act and the Delaware General Corporation Law. Our principal executive offices are located at 4710 Bellaire Boulevard, Suite 210, Bellaire, Texas 77401, and our telephone number is (832) 742-1357.

On February 22, 2024, we effected a reverse stock split of our outstanding shares of common stock at a ratio of 1-for-20, and our common stock began trading on the spilt-adjusted basis on the Nasdaq Capital Market at the commencement of trading on February 23, 2024. As a result of the reverse stock split, approximately 61,000 shares were added to our total shares outstanding due to rounding fractional shares of common stock up to a whole share of common stock. All common stock share and per share amounts in this Quarterly Report on Form 10-Q have been adjusted to give effect to the 1-for-20 reverse stock split.

On February 14, 2025, the Nasdaq Stock Market LLC notified the Company that the Nasdaq Hearings Panel determined to delist the Company’s common stock, par value $0.001 per share. On February 19, 2025, trading of our common stock was suspended on The Nasdaq Capital Market and trading of our Common Stock commenced on the OTCQB Venture Market under the ticker symbol “BPTH.”

Recent Accounting Pronouncements

There are no recent accounting pronouncements that have a material impact on our condensed consolidated financial statements.

Table of Contents

Financial Operations Overview

Revenue

We have not generated significant revenues to date. Our ability to generate revenues from our drug candidates, which we do not expect will occur for many years, if ever, will depend heavily on the successful development and eventual commercialization of our drug candidates.

Table of Contents

In the future, we may generate revenue from a combination of product sales, third-party grants, service agreements, strategic alliances and licensing arrangements. We expect that any revenue we generate will fluctuate due to the timing and amount of services performed, milestones achieved, license fees earned and payments received upon the eventual sales of our drug candidates, in the event any are successfully commercialized. If we fail to complete the development of any of our drug candidates or obtain regulatory approval for them, our ability to generate future revenue will be adversely affected.

Research and development expenses

Research and development expenses consist of costs associated with our research activities, including the development of our drug candidates. Our research and development expenses consist of:

• expenses related to research and development personnel, including salaries and benefits, travel and stock-based compensation; • external research and development expenses incurred under arrangements with third parties, such as contract research organizations, clinical investigative sites, laboratories, manufacturing organizations and consultants; and • costs of materials used during research and development activities.

• external research and development expenses incurred under arrangements with third parties, such as contract research organizations, clinical investigative sites, laboratories, manufacturing organizations and consultants; and

• costs of materials used during research and development activities.

Costs and expenses that can be clearly identified as research and development are charged to expense as incurred. Advance payments, including non-refundable amounts, for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts will be recognized as an expense as the related goods are delivered or the related services are performed. If the goods are not delivered, or services will not be rendered, then the capitalized advance payment is charged to expense.

We expect research and development expenses associated with the completion of the associated clinical trials to be substantial and to increase over time. The successful development of our drug candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete development of our drug candidates or the period, if any, in which material net cash inflows from our drug candidates may commence. This is due to the numerous risks and uncertainties associated with developing drugs, including the uncertainty of:

• the rate of progress, results and costs of completion of ongoing clinical trials of our drug candidates; • the size, scope, rate of progress, results and costs of completion of any potential future clinical trials and preclinical tests of our drug candidates that we may initiate; • competing technological and market developments; • the performance of third-party manufacturers and suppliers; • the ability of our drug candidates, if they receive regulatory approval, to achieve market success; • disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our drug candidates; and • the impact, risks and uncertainties related to global pandemics and actions taken by governmental authorities or others in connection therewith.

~~• the size, scope, rate of progress, results and costs of completion of any potential future clinical trials and preclinical tests of our drug candidates that we may initiate;~~20

• competing technological and market developments;

• the performance of third-party manufacturers and suppliers;

• the ability of our drug candidates, if they receive regulatory approval, to achieve market success;

• disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our drug candidates; and

• the impact, risks and uncertainties related to global pandemics and actions taken by governmental authorities or others in connection therewith.

Table of Contents

A change in the outcome of any of these variables with respect to the development of a drug candidate could mean a significant change in the costs and timing associated with the development of that drug candidate. For example, if the FDA or other regulatory authority were to require us to conduct clinical trials beyond those which we currently anticipate will be required for the completion of clinical development of a drug candidate or if we experience significant delays in enrollment in any clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development.

General and administrative expenses

Our general and administrative expenses consist primarily of salaries and benefits for management and administrative personnel, professional fees for legal, accounting and other services, travel costs and facility-related costs such as rent, utilities and other general office expenses.

Results of Operations

Comparisons of the Three Months Ended ~~September~~ 30March 31, 2026 ~~2025~~ to the Three Months Ended ~~September~~March 3031, ~~2024~~2025

Revenue. We had no revenue for each of the three months ended ~~September~~March 3031, ~~2025~~2026 and ~~2024~~2025.

Research and Development Expense. Our research and development expense for the three months ended ~~September~~March 3031, ~~2025~~2026 was $0.31 million, a decrease of $1.09 million compared to the three months ended ~~September~~March 3031, ~~2024~~2025. The decrease in research and development expense was primarily due to cash flow constraints and related pausing our clinical trials for BP1001 and BP1001-A. ~~The~~Our ~~following~~clinical ~~table~~trials ~~sets~~are ~~forth~~currently ~~our~~on ~~research and development expenses (in thousands):~~hold.

General and Administrative Expense. Our general and administrative expense for the three months ended ~~September~~March 3031, ~~2025~~2026 was $0.23 million, a decrease of $1~~.1 million~~ million compared to the three months ended ~~September~~March 3031, ~~2024~~2025. The decrease in general and administrative expense was primarily due to decreased salaries and benefits expenses due to the curtailment of the Company’s activities, including the resignations and terminations of employment of corporate overhead.

Net Operating Loss. Our net loss from operations for the three months ended ~~September~~March 3031, ~~2025~~2026 was $0.53 million, a decrease of $2.19 million compared to the three months ended ~~September~~ 30March 31, ~~2024~~2025.

Other Income (Expense) ~~The~~ The Company recognized ~~losses~~income of $0.31 million on the change in value of the warrant liability and derivative liabilities, compared to gains of $0.54 for the three months ended ~~September~~March 3031, ~~2024~~2025. ~~The Company incurred interest expense of $0.1 compared to income of $0.0 for the three months ended September 30, 2024.~~

Net Loss. Our net ~~loss~~ loss for the three months ended ~~September~~March 3031, ~~2025~~2026 was $1.0.3 million, a decrease of $12.16 million compared to the three months ended ~~September 30~~March 31, ~~2024~~2025.

Net Loss per Share. Net loss per share, both basic and diluted, for the three months ended ~~September~~March 3031, ~~2025~~2026 was $(0.1103), compared to $1(0.7040) for the three months ended ~~September~~March 3031, ~~2024~~2025. Net loss per share is calculated using the weighted average number of shares of common stock outstanding during the applicable periods and excludes stock options and warrants because they are antidilutive.

Comparisons of the Nine Months Ended September 30, 2025 to the Nine Months Ended September 30, 2024

Revenue. We had no revenue for each of the nine months ended September 30, 2025 and 2024.

Research and Development Expense. Our research and development expense for the nine months ended September 30, 2025 was $6.3 million, an increase of $0.8 million compared to the nine months ended September 30, 2025. The increase in research and development expense was primarily due to expenses related to pausing our clinical trials for BP1001 and BP1001-A as well as increased manufacturing expenses related to drug product releases in 2025, prior to our cash flow restraints in the 3rd Quarter.

Table of Contents

General and Administrative Expense. Our general and administrative expense for the nine months ended September 30, 2025 was $2.0 million, a decrease of $1.9 million compared to the nine months ended September 30, 2024. The decrease in general and administrative expense was primarily due to decreased salaries and benefits expense, professional and consulting fees and shareholder meeting expenses related to our special shareholder meeting held in the first quarter of 2024, as well as the curtailment of the Company’s activities, including the resignations and terminations of employment of corporate overhead in the 3rd Quarter.

Net Operating Loss. Our net loss from operations for the nine months ended September 30, 2025 was $8.3 million, a decrease of $1.1 million compared to the nine months ended September 30, 2024.

Other Income (Expense) The Company recognized losses of $0.0 million on the change in value of the warrant liability and derivative liabilities, compared to gains of $2.2 for the nine months ended September 30, 2024. The Company incurred interest expense of $0.1 compared to income of $0.0 for the nine months ended September 30, 2024.

Net Loss. Our net loss for the nine months ended June 30, 2025 was $8.4 million, a decrease of $1.3 million compared to the nine months ended September 30, 2024.

Net Loss per Share. Net loss per share, both basic and diluted, for the nine months ended September 30, 2025 was $1.06, compared to $4.05 for the nine months ended September 30, 2024. Net loss per share is calculated using the weighted average number of shares of common stock outstanding during the applicable periods and excludes stock options and warrants because they are antidilutive.

Liquidity and Capital Resources

Overview

We have not generated significant revenues to date. Since our inception, we have funded our operations primarily through public and private offerings of our capital stock and other securities. We expect to finance our foreseeable cash requirements through cash on hand, cash from operations, debt financings and public or private equity offerings. We may seek to access the public or private equity markets whenever conditions are favorable; however, there can be no assurance that we will be able to raise additional capital when needed or on terms that are favorable to us, if at all. Additionally, we may seek collaborations and license arrangements for our drug candidates. We currently have no lines of credit or other arranged access to debt financing.

We had a cash balance of $0.0 million as of September 30, 2025, a decrease of $1.2 million compared to December 31, 2024. We do not believe that our available cash at September 30, 2025 will be sufficient to meet obligations and fund our liquidity and capital expenditure requirements for the next 12 months from the date of this Quarterly Report on Form 10-Q. The Company’s ability to continue as a going concern is dependent upon obtaining funding through one or more sources as described above to meet its planned obligations and pay its liabilities.21

Cash Flows

Operating Activities. Net cash used in operating activities for the nine months ended September 30, 2025 was $1.6 million. Excluding non-cash expenses of $0.4 million, net cash used in operating activities for the nine months ended September 30, 2025 consisted primarily of the net loss for the period of $8.4 million, an increase in accounts payable and accrued expenses of $4.6 million, a decrease in other current assets of $1.3 million and a decrease in prepaid drug product of $0.6 million.

Net cash used in operating activities for the nine months ended September 30, 2024 was $7.7 million. Excluding non-cash gains of $1.7 million, net cash used in operating activities for the nine months ended June 30, 2024 consisted primarily of the net loss for the period of $7.1 million and an increase in other current assets of $0.5 million. These are partially offset by an increase in accounts payable and accrued expenses of $1.6 million and a decrease in prepaid drug product of $0.1 million.

Table of Contents

~~Financing~~We ~~Activities~~had a cash balance of $0. ~~Net~~1 million as of March 31, 2026, an increase of $0.1 million compared to December 31, 2025. We do not believe that our available cash ~~provided~~at byMarch ~~financing~~31, ~~activities~~2026 will be sufficient to meet obligations and fund our liquidity and capital expenditure requirements for the ~~nine~~next 12 months ~~ended~~from ~~September~~the ~~30,~~date of ~~2025~~this ~~was~~Quarterly $0Report on Form 10-Q.4 ~~million~~The ~~from~~Company’s ~~the~~ability ~~Warrant~~to ~~Exercises~~continue (as ~~defined~~a going concern is dependent upon obtaining funding ~~below),~~through ~~the~~one ~~March~~or ~~2025~~more ~~Promissory~~sources ~~Notes~~as ~~and~~described ~~the~~above ~~April~~to ~~Promissory~~meet ~~Note~~its planned obligations and pay its liabilities.

~~Net~~Cash cash provided by financing activities for the nine months ended September 30, 2024 was $7.2 million from the March 2024 Registered Direct Offering, the April 2024 Registered Direct Offering, the Offering Agreement (as defined below) and the June 2024 PIPE.Flows

~~2022~~Operating ~~Shelf~~Activities. Net cash ~~Registration~~used ~~Statement~~in operating activities for the three months ended March 31, 2026 was $0.1 million. Excluding non-cash expenses of $0.1 million, net cash used in operating activities for the nine months ended September 30, 2025 consisted primarily of the net loss for the period of $0.3 million, an increase in accounts payable and accrued expenses of $0.3 million, and a decrease in other current assets of $0.2 million.

OnNet ~~May~~cash ~~27,~~used ~~2022,~~in ~~we filed~~operating aactivities ~~shelf~~for ~~registration~~the ~~statement~~three onmonths ~~Form~~ended ~~S-3~~March ~~with the SEC~~31, ~~which~~2025 was ~~declared~~$1.3 ~~effective by the SEC on June 14, 2022 (File No~~million. ~~333~~Excluding non-~~265282) (the~~cash ~~“2022~~change ~~Shelf~~in ~~Registration~~fair ~~Statement”),~~value atof ~~which time~~ the ~~offering~~warrant liability of ~~unsold~~$0.4 ~~securities~~million ~~under~~and astock-based ~~previous~~compensation ~~shelf~~expense ~~registration statement~~of on$0.1 ~~Form~~million,. ~~S-3~~net ~~filed~~cash ~~with~~used ~~the~~in ~~SEC,~~operating ~~which~~activities ~~was~~for ~~declared effective by~~ the ~~SEC~~three onmonths ~~June 5, 2019 (File No. 333-231537) (the “2019~~ended ~~Shelf~~March ~~Registration Statement”)~~31, ~~was~~2025 ~~deemed~~consisted ~~terminated~~primarily ~~pursuant~~of ~~to Rule 415(a)(6) under~~ the ~~Securities~~net ~~Act.~~loss ~~The~~for ~~2022 Shelf Registration Statement was filed to register~~ the ~~offering,~~period ~~issuance and sale~~ of ~~(i) up to~~ $~~110~~2.09 million ~~of our common stock~~, ~~preferred~~an ~~stock,~~increase ~~warrants to purchase common stock or preferred stock or any combination thereof, either individually or~~ in ~~units,~~accounts ~~(ii)~~payable upand toaccrued expenses of $91.02 million ofand ~~our common~~a ~~stock~~decrease ~~under~~in ~~our~~prepaid Atdrug ~~The~~product ~~Market Offering Agreement (the “Offering Agreement”), dated as~~ of ~~July 13, 2020, with H~~$0.6 Cmillion. ~~Wainwright~~ &Net ~~Co.,~~cash ~~LLC~~used ~~(“Wainwright”),~~in ~~pursuant~~operating toactivities ~~which~~for wethe ~~could~~three ~~offer~~months ~~and sell, from time to time, through or to Wainwright,~~ended ~~shares~~March ~~of our common stock~~31, ~~which~~2024 ~~$9.0 million~~ was ~~subsequently reduced to~~ $31.0 million. ~~pursuant~~Excluding tonon-cash achange ~~prospectus~~in ~~supplement~~fair ~~filed~~value ~~with the SEC on July 29, 2022, and (iii) up to 11,895 shares~~ of ~~our common stock pursuant to~~ the ~~exercise~~warrant liability of ~~warrants outstanding on May 27, 2022. The~~ $3.0.5 million ofand ~~our common~~ stock-based ~~that could previously be offered, issued and sold under the Offering Agreement was included~~compensation inexpense ~~the~~of $~~110.~~0.2 million ~~of our securities that may be offered~~, ~~issued~~net ~~and~~cash ~~sold.~~used Onin ~~December~~operating 7,activities ~~2022,~~for wethe ~~received~~three ~~written~~months ~~notice~~ended ~~from~~March ~~Wainwright that Wainwright had elected~~31, ~~pursuant~~2024 toconsisted ~~Section~~primarily ~~8(b)~~ of the ~~Offering~~net loss ~~Agreement~~for ~~to terminate~~ the ~~Offering~~period ~~Agreement effective as~~ of ~~December 7, 2022~~$3.2 Asmillion ofand ~~the~~a ~~date~~decrease ~~hereof,~~of we$0.5 ~~are~~million ~~not~~in ~~eligible~~other tocurrent ~~utilize the 2022 Shelf Registration Statement~~assets. ~~The~~These ~~foregoing~~are ~~does~~partially ~~not~~offset ~~constitute~~ by an ~~offer to sell or the solicitation~~ increase of an$1.9 ~~offer~~million ~~to buy securities, and shall not constitute an offer, solicitation or sale~~ in ~~any~~operating ~~jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction~~liabilities.

~~March~~Financing ~~2024~~Activities. Net cash ~~Registered~~provided ~~Direct~~by ~~Offering and~~financing activities for the three months ended March ~~2024~~31, ~~Private~~2026 ~~Placement~~was $0.1 million from proceeds of Promissory Notes.

OnNet ~~March~~cash ~~25,~~provided ~~2024,~~by wefinancing ~~entered~~activities ~~into~~for athe ~~securities~~three ~~purchase~~months ~~agreement~~ended ~~with~~March ~~a certain institutional and accredited investor pursuant to which we agreed to sell~~31, in a2025 ~~registered~~was ~~direct offering, an aggregate of 75,000 shares of our common stock for gross proceeds of approximately~~ $0.3 million ~~under the~~from ~~base prospectus contained in~~ the ~~2022~~Warrant ~~Shelf~~Exercises ~~Registration Statement~~ and ~~a related prospectus supplement filed with~~ the ~~SEC~~March on2025 ~~March 27,~~Promissory ~~2024~~Notes (~~the~~each as ~~“March~~defined ~~2024 Registered Direct Offering”~~below). InNet acash ~~concurrent~~provided ~~private~~by ~~placement,~~financing weactivities ~~also~~for ~~agreed pursuant to~~ the ~~securities~~ ~~purchase~~three ~~agreement~~months toended ~~issue~~March ~~to such investor warrants to purchase up to 75~~31,~~000~~ ~~shares~~2024 ofwas ~~our common stock at an exercise price of~~ $30.~~865~~2 ~~per~~million ~~share~~from (the “March 2024 ~~Private Placement”). The March 2024~~ Registered Direct Offering ~~and the March 2024 Private Placement closed on March 27, 2024~~ . The net proceeds from the offerings, after deducting the placement agent’s fees and expenses and our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $0.2 million.

At the Market Offering

On April 4, 2024, we entered into the At The Market Offering Agreement with Wainwright, as sales agent, pursuant to which we may offer and sell, from time to time, through Wainwright, shares of our common stock. Under the At The Market Offering Agreement, Wainwright may sell shares by any method deemed to be an “at the market” offering as defined in Rule 415 under the Securities Act, as amended, or any other method permitted by law, including in privately negotiated transactions. We or Wainwright may suspend or terminate the offering of shares upon notice to the other party and subject to other conditions. We will pay Wainwright a commission of 3.0% of the aggregate gross proceeds from each sale of shares under the At The Market Offering Agreement and have agreed to provide Wainwright with customary indemnification and contribution rights. We have also agreed to reimburse Wainwright for certain specified expenses. We are subject to certain restrictions on our ability to offer and sell shares of our common stock under the At The Market Offering Agreement. On April 4, 2024, in connection with the execution of the At The Market Offering Agreement, we filed with the SEC a prospectus supplement (the “Initial ATM Prospectus Supplement”) to the base prospectus contained in the 2022 Shelf Registration Statement, which Initial ATM Prospectus Supplement related to the offering of up to $2.0 million of shares of the Company’s common stock under the At The Market Offering Agreement. Subsequent to entering into the Offering Agreement, we offered and sold 436,511 shares of common stock for gross proceeds of approximately $2.0 million and terminated the offering under the Initial ATM Prospectus Supplement on April 19, 2024. The net proceeds from such offering, after deducting commissions and our offering expenses, were approximately $1.8 million.

Table of Contents

On April 19, 2024, we determined to increase the number of shares available for sale under the At The Market Offering Agreement, up to an additional aggregate offering price of approximately $1.1 million, which shares are being offered and sold pursuant to the 2022 Shelf Registration Statement and a prospectus supplement and accompanying prospectus filed with the SEC on April 19, 2024 (the “Subsequent ATM Prospectus Supplement”). As of June 30, 2025, we have offered and sold 334,929 shares of common stock under the Subsequent ATM Prospectus Supplement for gross proceeds of approximately $1.1 million and after deducting commissions and the Company’s offering expenses, the net proceeds from such offering were approximately $1.0 million.

April 2024 Registered Direct Offering and April 2024 Private Placement

On April 18, 2024, we entered into a securities purchase agreement with certain institutional and accredited investors pursuant to which we agreed to sell, in a registered direct offering, an aggregate of 375,000 shares of our common stock for gross proceeds of approximately $1.2 million under the base prospectus contained in the 2022 Shelf Registration Statement and a related prospectus supplement filed with the SEC on April 19, 2024 (the “April 2024 Registered Direct Offering”). In a concurrent private placement, we also agreed pursuant to the securities purchase agreement to issue to such investors warrants to purchase up to 375,000 shares of our common stock at an exercise price of $3.10 per share (the “April 2024 Private Placement”). The April 2024 Registered Direct Offering and the April 2024 Private Placement closed on April 19, 2024. The net proceeds from the offerings, after deducting the placement agent’s fees and expenses and our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $0.9 million.

June 2024 PIPE

On June 3, 2024, we entered into a securities purchase agreement with a certain institutional and accredited investor pursuant to which we agreed to sell, in a private placement, an aggregate of (i) 180,000 shares of our common stock, (ii) pre-funded warrants to purchase up to 1,629,955 shares of our common stock at an exercise price of $0.001 per share, (iii) series A warrants to purchase up to 1,809,955 shares of our common stock at an exercise price of $2.00 per share and (iv) series B warrants to purchase up to 1,809,955 shares of our common stock at an exercise price of $2.00 per share for gross proceeds of approximately $4.0 million (the “June 2024 PIPE”). The June 2024 PIPE closed on June 5, 2024. The net proceeds from the offering, after deducting the placement agent’s fees and expenses and our offering expenses, and excluding the proceeds, if any, from the exercises of the warrants issued in the offering, were approximately $3.3 million.

October 2024 Private Placement

On October 8, 2024, we entered into a securities purchase agreement with a certain institutional and accredited investor pursuant to which we agreed to sell, in a private placement, an aggregate of (i) pre-funded warrants to purchase up to 4,597,702 shares of our common stock at an exercise price of $0.001 per share, (ii) series A warrants to purchase up to 6,407,657 shares of our common stock at an exercise price of $1.00 per share and (iii) series B warrants to purchase up to 6,407,657 shares of our common stock at an exercise price of $1.00 per share for gross proceeds of approximately $4.0 million (the “October 2024 Private Placement”). The October 2024 Private Placement closed on October 10, 2024 (the “Closing Date”). In connection with the October 2024 Private Placement, the Company and the investor agreed to cancel such investor’s series A warrants to purchase 1,809,955 shares of common stock at an exercise price of $2.00 and series B warrants to purchase 1,809,955 shares of common stock at an exercise price of $2.00 issued to such investor in connection with the June 2024 PIPE, effective as of the Closing Date. The net proceeds from the offering, after deducting the placement agent’s fees and expenses and our offering expenses, and excluding the proceeds, if any, from the exercises of the warrants issued in the offering, were approximately $3.5 million.

Table of Contents

Pre-Funded Warrant Exercises

In February 2025, investors exercised our remaining outstanding pre-funded warrants to purchase 2,540,000 shares of our common stock at a weighted average exercise price of approximately $0.001 per share (such exercises, the “Warrant Exercises”).

March 2025 Promissory Notes

On March 6, 2025, we entered into a securities purchase agreement with 1800 Diagonal Lending LLC, a Virginia limited liability company (the “Lender”), an accredited investor, for the issuance and sale of a promissory note in the aggregate principal amount of $161,000 (the “First Promissory Note”) for a purchase price of $140,000 after deducting the original issue discount of $21,000. The First Promissory Note bears a one-time interest charge of twelve percent that is applied on the date of issuance, March 6, 2025. The First Promissory Note shall be paid in five payments with the first payment of $90,160 due on August 30, 2025 and each subsequent payment shall be equal to $22,540 which are due on September 30, 2025, October 30, 2025, November 30, 2025 and December 30, 2025.

On March 28, 2025, we entered into a securities purchase agreement with the Lender, an accredited investor, for the issuance and sale of a promissory note in the aggregate principal amount of $100,050 (the “Second Promissory Note” and together, with the First Promissory Note, the “March 2025 Promissory Notes”) for a purchase price of $87,000 after deducting the original issue discount of $13,050. The Second Promissory Note bears a one-time interest charge of twelve percent that is applied on the date of issuance, March 28, 2025. The Second Promissory Note shall be paid in five payments with the first payment of $56,028 due on September 30, 2025 and each subsequent payment shall be equal to $14,007 which are due on October 30, 2025, November 30, 2025, December 30, 2025 and January 30, 2026.

Table of Contents

Upon the occurrence and during any continuation of any Event of Default (as defined in the March 2025 Promissory Notes), the March 2025 Promissory Notes shall become immediately due and payable and we shall pay to the Lender, in full satisfaction, an amount equal to 150% times the sum of (i) the then outstanding principal amount of such Promissory Note plus (ii) accrued and unpaid interest on the unpaid principal amount of such Promissory Note to the date of payment plus (iii) default interest, if any, at a rate of 22% per annum on the amounts referred to in clauses (i) and/or (ii) plus (iv) any amounts owed to the Lender pursuant to the Conversion Right (as defined below). In addition, only upon an Event of Default and during any continuation thereof, the Lender may elect to convert all or any part of the outstanding principal and interest on the March 2025 Promissory Notes in fully paid and non-assessable shares of the Company’s common stock at a conversion price per share equal to 65% of the lowest closing bid price of the common stock for the ten trading days prior to the date of conversion (the “Conversion Right”). The Lender, together with its affiliates, may not convert any portion of such Promissory Note to the extent that the Lender would own more than 4.99% of the Company’s outstanding common stock immediately after the conversion.

April 2025 Promissory Note

On April 28, 2025, we entered into a securities purchase agreement with Quick Capital, LLC, a Wyoming limited liability company (the “Second Lender”), an accredited investor, for the issuance and sale of a promissory note in the aggregate principal amount of $161,000 (the “April 2025 Promissory Note”) for a purchase price of $140,000 after deducting the original issue discount of $21,000. The April 2025 Promissory Note bears a one-time interest charge of twelve percent that is applied on the date of issuance, April 28, 2025. The April 2025 Promissory Note shall be paid in five payments with the first payment of $90,160 due on October 15, 2025 and each subsequent payment shall be equal to $22,540 which are due on November 15, 2025, December 15, 2025, January 15, 2026 and February 15, 2026.

27As of March 31, 2026, the March 2025 Promissory Notes and April 2025 Promissory Note were in default and became convertible under the default provisions.

Table of Contents

Upon the occurrence and during any continuation of any Event of Default (as defined in the April 2025 Promissory Note), the April 2025 Promissory Note shall become immediately due and payable and we shall pay to the Second Lender, in full satisfaction, an amount equal to 150% times the sum of (i) the then outstanding principal amount of the April 2025 Promissory Note plus (ii) accrued and unpaid interest on the unpaid principal amount of the April 2025 Promissory Note to the date of payment plus (iii) default interest, if any, at a rate of 22% per annum on the amounts referred to in clauses (i) and/or (ii) plus (iv) any amounts owed to the Second Lender pursuant to the Conversion Right (as defined below). In addition, only upon an Event of Default and during any continuation thereof, the Second Lender may elect to convert all or any part of the outstanding principal and interest on the April 2025 Promissory Note in fully paid and non-assessable shares of the Company’s common stock at a conversion price per share equal to 65% of the lowest closing bid price of the common stock for the ten trading days prior to the date of conversion (the “Conversion Right”). The Second Lender, together with its affiliates, may not convert any portion of the April 2025 Promissory Note to the extent that the Second Lender would own more than 4.99% of the Company’s outstanding common stock immediately after the conversion.

As of September 30, 2025, the March 2025 Promissory Notes were in default and became convertible under the default provisions.

Subsequent to September 30, 2025, the Company defaulted on the April 2025 Promissory Note

January 2026 Promissory Notes

Table of Contents

Future Capital Requirements

We expect to continue to incur significant operating expenses in connection with our ongoing activities, including conducting clinical trials, manufacturing and seeking regulatory approval of our drug candidates, prexigebersen, BP1002, BP1003 and BP1001-A. Accordingly, we will continue to require substantial additional capital to fund our projected operating requirements. Such additional capital may not be available when needed or on terms favorable to us. In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current and future operating plan. There can be no assurance that we will be able to continue to raise additional capital through the sale of our securities in the future. Our future capital requirements may change and will depend on numerous factors, which are discussed in detail in “Item 1A. Risk Factors” to Part I of our Annual Report on Form 101-K as of the fiscal year ended December 31, ~~2024~~2025. For more information, see Note 1 to the Unaudited Condensed Consolidated Financial Statements included herein.

Off-Balance Sheet Arrangements

As of ~~September~~March 3031, ~~2025~~2026, we did not have any ~~material~~ material off-balance sheet arrangements.

Critical Accounting Policies

The preparation of financial statements in conformity with generally accepted accounting principles in the United States has required our management to make assumptions, estimates and judgments that affect the amounts reported in the financial statements, including the notes thereto, and related disclosures of commitments and contingencies, if any. We consider our critical accounting policies to be those that require the more significant ~~judgments~~ judgments and estimates in the preparation of financial statements. There have been no significant changes to our critical accounting policies from those disclosed in Note 2 to our Consolidated Financial Statements included in our Annual Report on Form 101-K as of the year ended December 31, ~~2024~~2025.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not applicable.

Table of Contents

ITEM 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

It is management’s responsibility to establish and maintain adequate disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Disclosure controls and procedures are controls and other procedures of a company that are designed to ensure that information required to be disclosed by the company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to management, including the company’s principal executive and principal financial officers, as appropriate, to allow timely decisions regarding required disclosure.

Our management, including our Chief Executive Officer (who is also our Chief Financial Officer), has reviewed and evaluated the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of the end of the period covered by this Quarterly Report on Form 10-Q. Following this review and evaluation, our management determined that as of the end of the period covered by this Quarterly Report on Form 10-Q, our disclosure controls and procedures were not effective to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and is accumulated and communicated to management, including our Interim Chief Executive Officer and our Interim Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

Changes in Internal Control over Financial Reporting

2924

Table of Contents

PART II – OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

None.

ITEM 1A. RISK FACTORS

The operational pause, furlough of employees or other actions we take to conserve cash and fund our operations may not achieve our intended outcome

On June 24, 2025, we implemented an operational pause in order to conserve capital while we seek potential fundraising transactions. As a result of our inability to secure meaningful funding prior to such operational pause, we also announced the furlough of most of our employees, in order to reduce expenses. These or other actions we may take may result in unintended consequences and costs, such as the loss of institutional knowledge and expertise, attrition beyond the intended number of employees, decreased morale among our remaining employees, and the risk that we may not achieve the anticipated benefits of the operational pause. In addition, while most employees have been furloughed, certain functions necessary to our operations remain, and we may be unsuccessful in distributing the duties and obligations of furloughed employees. The operational pause could also make it difficult for us to pursue, or prevent us from pursuing, new opportunities and initiatives due to insufficient personnel, or require us to incur additional and unanticipated costs to hire new personnel to pursue such opportunities or initiatives. If we are unable to realize the anticipated benefits from the operational pause, or if we experience significant adverse consequences from the operational pause, our business, financial condition, and results of operations may be materially adversely affected.

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

None.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None.

ITEM 4. MINE SAFETY DISCLOSURES

None.

ITEM 5. OTHER INFORMATION

Insider Adoption or Termination of Trading Arrangements

During the last fiscal quarter, none of our directors or officers adopted or terminated any “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as those terms are defined in Regulation S-K, Item 408.

Appointment of Interim Chief Executive Officer and Interim Chief Financial Officer

On August 14, 2025, the Board of Directors appointed Douglas P. Morris, as interim Chief Executive Officer and interim Chief Financial Officer, to serve as such until a permanent Chief Executive Officer and Chief Financial Officer have been identified and elected. At this time, Mr. Morris is the only officer of the Company. Mr. Morris is a co-founder of Bio-Path and has served as a director of Bio-Path since 2007 and previously served as an officer from 2007 to June 2014. Mr. Morris also currently serves as the Director of Investor Relations and the Secretary of Bio-Path. Mr. Morris serves as an officer and director of two publicly traded companies seeking business merger combinations: Spirits Time International, Inc. (OTC Markets: SRSG) and Bioethics, LTD. (OTC Markets: BOTH). Mr. Morris previously served as a co-founder, Managing Member, and Secretary of nCAP Holdings, LLC, a privately held technology-based company from September 2013 to January 2016. Between 1993 and 2010, Mr. Morris was an officer and director of Celtic Investment, Inc., a financial services company. Mr. Morris owned and operated Hyacinth Resources, LLC, a business consulting firm, from 1990 until September 2018, and is also a Managing Member of Sycamore Ventures, LLC, a privately held consulting firm. Mr. Morris has a B.A. from Brigham Young University, and attended the University of Southern California Master’s program in public administration.

3025

Table of Contents

On October 22, 2025, the Board of Directors (the “Board”) of the Company elected and appointed Vikram Grover as President, Chief Executive Officer, Chief Financial Officer, and member of the Board.

On October 22, 2025, the Board of the Company accepted the resignation of Douglas Morris as Interim Chief Executive Officer and Interim Chief Financial Officer. Mr. Morris continues to be a member of the Board.

On October 22, 2025, the Board of the Company accepted the resignation of Paul Aubert as Director.

On November 13, 2025, the Company accepted the resignation of Doug Morris from the Board of Directors

ITEM 6. EXHIBITS

Exhibit No.		Description of Exhibit
2.1		Agreement and Plan of Merger and Reorganization dated September 27, 2007, by and among the Company, Biopath Acquisition Corp., a Utah corporation and wholly owned subsidiary of the registrant, and Bio-Path, Inc., a Utah corporation (incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed on September 27, 2007).
3.1		Certificate of Incorporation (incorporated by reference to Exhibit 3.3 to the Company’s Current Report on Form 8-K filed on January 6, 2015).
3.2		Certificate of Amendment to the Certificate of Incorporation of Bio-Path Holdings, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on February 9, 2018).
3.3		Certificate of Amendment to the Certificate of Incorporation of Bio-Path Holdings, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on January 16, 2019).
3.4		Certificate of Amendment to the Certificate of Incorporation of Bio-Path Holdings, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on February 23, 2024).
3.5		First Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on June 7, 2017).
3.6		Amendment No. 1 to the First Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on December 8, 2023).
4.1		Promissory Note, dated as of April 28, 2025, issued by the Company in favor of the Second Lender (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on April 29, 2025).
10.1		Securities Purchase Agreement, dated as of April 28, 2025, by and between the Company and the Second Lender (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on April 29, 2025).
10.2		Second Amendment to Lease Agreement, dated April 10, 2025, by and between the Company and HJF Properties, LLC (incorporated by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q filed on May 15, 2025).
10.3		Bio-Path Holdings, Inc. Domestication to Wyoming 02/05-2026 (Incorporated by reference to Form 8-K filed March 20, 2026)
10.4		Amendment to Bio-Path Holdings, Inc. Articles of Incorporation: Creation of Series S Preferred Stock 01-02-2026 (Incorporated by reference to Form 8-K filed March 20, 2026)
10.5		Vanquish Funding Group Inc. Promissory Note: 12/29/2025 (Incorporated by reference to Form 1-A filed 03/25/2026)
10.6		Quick Capital LLC Promissory Note: 01/02/2026 (Incorporated by reference to Form 1-A filed 03/25/ 2026)
10.7		Bio-Path Holdings, Inc. Steel Giants Advisors LLC Consulting Agreement: 10/24/2025 (Incorporated by reference to Form 1-A filed 03/25/2026)
10.8		Steel Giants Advisors LLC Warrant: 01/02/2026 (Incorporated by reference to Form 1-A filed 03/25/2026)
10.9		Series S Preferred stock certificate of determination (Incorporated by reference to Form 1-K filed 05/01/2026)
31*		Certification of Principal Executive Officer and Principal Financial Officer pursuant to Exchange Act Rules 13a-14 and 15d-14, as adopted pursuant to Section 302 Sarbanes Oxley Act of 2002.
32**		Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002.
101*		The following financial statements from the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, formatted in Inline XBRL: (i) Condensed Consolidated Balance Sheets (Unaudited); (ii) Condensed Consolidated Statements of Operations (Unaudited); (iii) Condensed Consolidated Statements of Cash Flows (Unaudited); (iv) Condensed Consolidated Statements of Shareholders’ Equity (Unaudited); and (v) Notes to the Unaudited Condensed Consolidated Financial Statements, tagged as blocks of text and including detailed tags.
104*		The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, formatted in Inline XBRL (included as Exhibit 101).

* Filed herewith.

** Furnished herewith.

3126

Table of Contents

SIGNATURE

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

Dated:	~~January~~May 1220, 2026	BIO-PATH HOLDINGS, INC.
		By:	/s/ Vikram Grover
			Vikram Grover
			Chief Executive Officer (Principal Executive Officer) Chief Financial Officer (Principal Financial Officer)

3227

Table of Contents

Filing Compare · BIO-PATH HOLDINGS, INC.