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 June 30, 2024

☐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.)


4710 Bellaire Boulevard, Suite 210, Bellaire, Texas		77401
(Address of principal executive offices)		(Zip Code)

(832) 742-1357

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol	Name of each exchange on which registered
Common Stock, par value $0.001 per share	BPTH	The Nasdaq Capital Market

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 ☐

Indicate 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 August 8, 2024, the Company had 2,552,190 outstanding shares of common stock, par value $0.001 per share.

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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, 2023 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;

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●

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;

●

our ability to maintain effective internal controls over financial reporting; and

●

our ability to regain and maintain compliance with the listing standards of the Nasdaq Capital Market.

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, 2023, “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.

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TABLE OF CONTENTS


		Page
PART I - FINANCIAL INFORMATION		5
Item 1.	Financial Statements	5
	Condensed Consolidated Balance Sheets (Unaudited)	5
	Condensed Consolidated Statements of Operations (Unaudited)	6
	Condensed Consolidated Statements of Cash Flows (Unaudited)	7
	Condensed Consolidated Statements of Shareholders’ Equity (Unaudited)	8
	Notes to the Unaudited Condensed Consolidated Financial Statements	9
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	16
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	26
Item 4.	Controls and Procedures	26
PART II - OTHER INFORMATION		27
Item 1.	Legal Proceedings	27
Item 1A.	Risk Factors	27
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	27
Item 3.	Defaults Upon Senior Securities	27
Item 4.	Mine Safety Disclosures	27
Item 5.	Other Information	27
Item 6.	Exhibits	28
Signature		29

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PART I – FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

BIO-PATH HOLDINGS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except par value)


	As of June 30,		As of December 31,
	2024		2023
		(unaudited)
Assets

Current assets
Cash	$	4,006	$	1,052
Prepaid drug product		274		632
Other current assets		739		1,358
Total current assets		5,019		3,042

Fixed assets
Furniture, fixtures & equipment		1,120		1,120
Less accumulated depreciation		(1,072)		(1,044)
		48		76

Right of use operating assets		51		102

Total Assets	$	5,118	$	3,220
Liabilities & Shareholders' Equity
Current liabilities
Accounts payable	$	766	$	457
Accrued expenses		2,189		1,346
Current portion of lease liabilities		55		103
Total current liabilities		3,010		1,906

Warrant liability		817		863

Noncurrent lease liabilities		—		10

Total Liabilities		3,827		2,779

Shareholders' equity
Preferred stock, $.001 par value; 10,000 shares authorized; no shares issued and outstanding		—		—
Common stock, $.001 par value; 200,000 shares authorized; 2,283 and 618 shares issued and outstanding, respectively		2		1
Additional paid in capital		113,922		108,047
Accumulated deficit		(112,633)		(107,607)
Total shareholders' equity		1,291		441
Total Liabilities & Shareholders' Equity	$	5,118	$	3,220

SEE ACCOMPANYING NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

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BIO-PATH HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(Unaudited)


	Three Months Ended June 30,				Six Months Ended June 30,
	2024		2023		2024		2023

Operating expenses

Research and development	$	1,873	$	3,051	$	4,161	$	7,040
General and administrative		1,165		1,191		2,572		2,494

Total operating expenses		3,038		4,242		6,733		9,534

Net operating loss	$	(3,038)	$	(4,242)	$	(6,733)	$	(9,534)

Other income
Change in fair value of warrant liability		1,163		—		1,701		—
Interest income		6		8		6		27

Total other income		1,169		8		1,707		27

Net loss	$	(1,869)	$	(4,234)	$	(5,026)	$	(9,507)

Net loss per share, basic and diluted	$	(1.16)	$	(10.64)	$	(4.45)	$	(23.89)

Basic and diluted weighted average number of common shares outstanding		1,612		398		1,130		398

SEE ACCOMPANYING NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

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BIO-PATH HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)


	Six Months Ended June 30,
	2024		2023
Cash flow from operating activities

Net loss	$	(5,026)	$	(9,507)

Adjustments to reconcile net loss to net cash used in operating activities

Stock-based compensation		311		376
Amortization of right of use assets		51		47
Depreciation		28		44
Change in fair value of warrant liability		(1,701)		—
(Increase) decrease in operating assets
Prepaid drug product		358		2,518
Other current assets		619		(102)
Increase (decrease) in operating liabilities
Accounts payable and accrued expenses		1,152		(263)
Lease liabilities		(58)		(53)

Net cash used in operating activities		(4,266)		(6,940)

Cash flow from financing activities

Net proceeds from sale of common stock		7,220		—

Net cash provided by financing activities		7,220		—

Net increase (decrease) in cash		2,954		(6,940)

Cash, beginning of period		1,052		10,384

Cash, end of period	$	4,006	$	3,444

SEE ACCOMPANYING NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

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BIO-PATH HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY

(in thousands)

(Unaudited)


				Additional
	Common Stock			Paid in		Accumulated
Description	Shares	Amount		Capital		Deficit		Total

Balance at March 31, 2023	398	$	1	$	105,908	$	(96,802)	$	9,107

Stock-based compensation	—		—		170		—		170
Net loss	—		—		—		(4,234)		(4,234)

Balance at June 30, 2023	398	$	1	$	106,078	$	(101,036)	$	5,043


Balance at March 31, 2024	754	$	1	$	108,138	$	(110,764)	$	(2,625)

Issuance of common stock and warrants, net of fees and warrant liability	1,529		1		5,643		—		5,644
Stock-based compensation	—		—		141		—		141
Net loss	—		—		—		(1,869)		(1,869)

Balance at June 30, 2024	2,283	$	2	$	113,922	$	(112,633)	$	1,291


				Additional
	Common Stock			Paid in		Accumulated
Description	Shares	Amount		Capital		Deficit		Total

Balance at December 31, 2022	398	$	1	$	105,702	$	(91,529)	$	14,174

Stock-based compensation	—		—		376		—		376
Net loss	—		—		—		(9,507)		(9,507)

Balance at June 30, 2023	398	$	1	$	106,078	$	(101,036)	$	5,043


Balance at December 31, 2023	618	$	1	$	108,047	$	(107,607)	$	441

Issuance of common stock and warrants, net of fees and warrant liability	1,665		1		5,564		—		5,565
Stock-based compensation	—		—		311		—		311
Net loss	—		—		—		(5,026)		(5,026)

Balance at June 30, 2024	2,283	$	2	$	113,922	$	(112,633)

SEC Form 10-Q filed by Bio-Path Holdings Inc.