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 March 31, 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 May 9, 2024, the Company had 1,656,235 outstanding shares of common stock, par value $0.001 per share.


		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’ (Deficit) 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	15
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	23
Item 4.	Controls and Procedures	23
PART II - OTHER INFORMATION		25
Item 1.	Legal Proceedings	25
Item 1A.	Risk Factors	25
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	25
Item 3.	Defaults Upon Senior Securities	25
Item 4.	Mine Safety Disclosures	25
Item 5.	Other Information	25
Item 6.	Exhibits	26
Signature		27


	As of March 31,		As of December 31,
	2024		2023
Assets

Current assets
Cash	$	188	$	1,052
Prepaid drug product		632		632
Other current assets		817		1,358
Total current assets		1,637		3,042

Fixed assets
Furniture, fixtures & equipment		1,120		1,120
Less accumulated depreciation		(1,066)		(1,044)
		54		76

Right of use operating assets		77		102

Total Assets	$	1,768	$	3,220
Liabilities & Shareholders' (Deficit) Equity
Current liabilities
Accounts payable	$	1,746	$	457
Accrued expenses		1,984		1,346
Current portion of lease liabilities		82		103
Total current liabilities		3,812		1,906

Warrant liability		578		863

Noncurrent lease liabilities		3		10

Total Liabilities		4,393		2,779

Shareholders' (deficit) equity
Preferred stock, $.001 par value; 10,000 shares authorized; no shares issued and outstanding		—		—
Common stock, $.001 par value; 200,000 shares authorized; 754 and 398 shares issued and outstanding, respectively		1		1
Additional paid in capital		108,138		108,047
Accumulated deficit		(110,764)		(107,607)
Total shareholders' (deficit) equity		(2,625)		441
Total Liabilities & Shareholders' (Deficit) Equity	$	1,768	$	3,220


	Three Months Ended March 31,
	2024		2023

Operating expenses

Research and development	$	2,288	$	3,989
General and administrative		1,407		1,303

Total operating expenses		3,695		5,292

Net operating loss	$	(3,695)	$	(5,292)

Other income
Change in fair value of warrant liability		538		—
Interest income		—		19

Total other income		538		19

Net loss	$	(3,157)	$	(5,273)

Net loss per share, basic and diluted	$	(4.88)	$	(13.25)

Basic and diluted weighted average number of common shares outstanding		647		398


				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

Issuance of common stock, net of fees	—		—		—		—		—
Stock-based compensation	—		—		206		—		206
Net loss	—		—		—		(5,273)		(5,273)

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


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

Issuance of common stock, net of fees	136		—		(79)		—		(79)
Stock-based compensation	—		—		170		—		170
Net loss	—		—		—		(3,157)		(3,157)

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


	Fair Value Measurements at
	March 31, 2024
	(in thousands)
		Level 1		Level 2		Level 3		Total
Liabilities:
Warrant liability	$	—	$	—	$	578	$	578


	Fair Value Measurements at
	December 31, 2023
	(in thousands)
		Level 1		Level 2		Level 3		Total
Liabilities:
Warrant liability	$	—	$	—	$	863	$	863


	Fair Value of
	Warrant
	Liability
	(in thousands)
Balance at December 31, 2023	$	863
Issuance		253
Change in fair value		(538)
Balance at March 31, 2024	$	578


	As of
	March 31,
	2024
Risk-free interest rate		4.20	%
Expected volatility		104	%
Expected term in years		4.6
Dividend yield		—	%


		Weighted-
		Average
		Exercise
	Options	Price
	(in thousands)
Outstanding at December 31, 2023	43	$	161.20
Outstanding at March 31, 2024	43	$	160.78
Vested and expected to vest March 31, 2024	43	$	162.03
Exercisable at March 31, 2024	27	$	224.38


	Three Months Ended
	March 31,
	2024		2023
Research and development expense	$	2,248	$	3,940
Non-cash stock-based compensation expense		40		49
Total research and development expense	$	2,288	$	3,989


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		Form of Common Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on March 26, 2024).
4.2		Form of Placement Agent Common Stock Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on March 26, 2024).
4.3		Form of Common Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on April 19, 2024).
4.4		Form of Placement Agent Common Stock Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on April 19, 2024).
10.1		Form of Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on March 26, 2024).
10.2		At The Market Offering Agreement, dated as of April 4, 2024, by and between the Company and H.C. Wainwright & Co., LLC (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on April 4, 2024).
10.3		Form of Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on April 19, 2024).
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 March 31, 2024, 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, 2024, formatted in Inline XBRL (included as Exhibit 101).


Dated:	May 14, 2024	BIO-PATH HOLDINGS, INC.

		By:	/s/ Peter H. Nielsen
			Peter H. Nielsen
			President
			Chief Executive Officer
			(Principal Executive Officer)
			Chief Financial Officer
			(Principal Financial Officer)

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