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, 2023

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

For the transition period from __________ to __________

Commission file number: 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 5, 2023, the Company had 7,960,164 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’ 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	13
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	19
Item 4.	Controls and Procedures	19
PART II - OTHER INFORMATION		21
Item 1.	Legal Proceedings	21
Item 1A.	Risk Factors	21
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	21
Item 3.	Defaults Upon Senior Securities	21
Item 4.	Mine Safety Disclosures	21
Item 5.	Other Information	21
Item 6.	Exhibits	22
Signature		23


	As of March 31,		As of December 31,
	2023		2022
		(unaudited)
Assets

Current assets
Cash	$	6,731	$	10,384
Prepaid drug product		2,396		3,587
Other current assets		1,664		1,644
Total current assets		10,791		15,615

Fixed assets
Furniture, fixtures & equipment		1,120		1,120
Less accumulated depreciation		(984)		(962)
		136		158

Right of use operating assets		175		198

Total Assets	$	11,102	$	15,971
Liabilities & Shareholders' Equity
Current liabilities
Accounts payable	$	827	$	667
Accrued expenses		973		909
Current portion of lease liabilities		110		108
Total current liabilities		1,910		1,684

Noncurrent lease liabilities		85		113

Total Liabilities		1,995		1,797
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; 7,960 and 7,960 shares issued and outstanding, respectively		8		8
Additional paid in capital		105,901		105,695
Accumulated deficit		(96,802)		(91,529)
Total shareholders' equity		9,107		14,174
Total Liabilities & Shareholders' Equity	$	11,102	$	15,971


	Three Months Ended March 31,
	2023		2022

Operating expenses

Research and development	$	3,989	$	2,098
General and administrative		1,303		1,261

Total operating expenses		5,292		3,359

Net operating loss	$	(5,292)	$	(3,359)

Other income
Interest income		19		—

Total other income		19		—

Net loss	$	(5,273)	$	(3,359)

Net loss per share, basic and diluted	$	(0.66)	$	(0.47)

Basic and diluted weighted average number of common shares outstanding		7,960		7,160


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

Balance at December 31, 2021	7,160	$	7	$	103,111	$	(77,661)	$	25,457

Stock-based compensation	—		—		217		—		217
Net loss	—		—		—		(3,359)		(3,359)

Balance at March 31, 2022	7,160	$	7	$	103,328	$	(81,020)	$	22,315


Balance at December 31, 2022	7,960	$	8	$	105,695	$	(91,529)	$	14,174

Stock-based compensation	—		—		206		—		206
Net loss	—		—		—		(5,273)		(5,273)

Balance at March 31, 2023	7,960	$	8	$	105,901	$	(96,802)	$	9,107


	2023		2022
Risk-free interest rate (1)	—	%	2.43	%
Expected volatility (1)	—	%	127	%
Expected term in years (1)	—		6.0
Dividend yield (1)	—	%	—	%



		Weighted-
		Average
		Exercise
	Options	Price
	(in thousands)

Outstanding at December 31, 2022	658	$	11.67
Granted	—		—
Forfeited	—		—
Expired	—		—
Outstanding at March 31, 2023	658	$	11.67
Vested and expected to vest March 31, 2023	640	$	11.85
Exercisable at March 31, 2023	393	$	16.08


	Three Months Ended
	March 31,
	2023		2022
Research and development expense	$	3,940	$	2,051
Non-cash stock-based compensation expense		49		47
Total research and development expense	$	3,989	$	2,098


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		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).
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, 2023, 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, 2023, formatted in Inline XBRL (included as Exhibit 101).


Dated:	May 11, 2023	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.