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, 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 August 8, 2023, the Company had 11,460,164 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	21
Item 4.	Controls and Procedures	21
PART II - OTHER INFORMATION		22
Item 1.	Legal Proceedings	22
Item 1A.	Risk Factors	22
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	22
Item 3.	Defaults Upon Senior Securities	22
Item 4.	Mine Safety Disclosures	22
Item 5.	Other Information	22
Item 6.	Exhibits	23
Signature		24


	As of June 30,		As of December 31,
	2023		2022
		(unaudited)
Assets

Current assets
Cash	$	3,444	$	10,384
Prepaid drug product		1,069		3,587
Other current assets		1,746		1,644
Total current assets		6,259		15,615

Fixed assets
Furniture, fixtures & equipment		1,120		1,120
Less accumulated depreciation		(1,006)		(962)
		114		158

Right of use operating assets		151		198

Total Assets	$	6,524	$	15,971
Liabilities & Shareholders' Equity
Current liabilities
Accounts payable	$	638	$	667
Accrued expenses		675		909
Current portion of lease liabilities		113		108
Total current liabilities		1,426		1,684

Noncurrent lease liabilities		55		113

Total Liabilities		1,481		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		106,071		105,695
Accumulated deficit		(101,036)		(91,529)
Total shareholders' equity		5,043		14,174
Total Liabilities & Shareholders' Equity	$	6,524	$	15,971


	Three Months Ended June 30,				Six Months Ended June 30,
	2023		2022		2023		2022

Operating expenses

Research and development	$	3,051	$	1,851	$	7,040	$	3,949
General and administrative		1,191		1,159		2,494		2,420

Total operating expenses		4,242		3,010		9,534		6,369

Net operating loss	$	(4,242)	$	(3,010)	$	(9,534)	$	(6,369)

Other income
Interest income		8		2		27		2

Total other income		8		2		27		2

Net loss	$	(4,234)	$	(3,008)	$	(9,507)	$	(6,367)

Net loss per share, basic and diluted	$	(0.53)	$	(0.42)	$	(1.19)	$	(0.89)

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


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

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

Stock-based compensation	—		—		213		—		213
Net loss	—		—		—		(3,008)		(3,008)

Balance at June 30, 2022	7,160	$	7	$	103,541	$	(84,028)	$	19,520


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

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

Balance at June 30, 2023	7,960	$	8	$	106,071	$	(101,036)	$	5,043


	2023		2022
Risk-free interest rate	3.42	%	2.43	%
Expected volatility	129	%	127	%
Expected term in years	6.0		6.0
Dividend yield	—	%	—	%



		Weighted-
		Average
		Exercise
	Options	Price
	(in thousands)

Outstanding at December 31, 2022	658	$	11.67
Granted	221		1.39
Outstanding at June 30, 2023	879	$	9.09
Vested and expected to vest June 30, 2023	822	$	9.23
Exercisable at June 30, 2023	428	$	15.18


	Three Months Ended
	June 30,
	2023		2022
Research and development expense	$	3,008	$	1,801
Non-cash stock-based compensation expense		43		50
Total research and development expense	$	3,051	$	1,851


	Six Months Ended
	June 30,
	2023		2022
Research and development expense	$	6,948	$	3,852
Non-cash stock-based compensation expense		92		97
Total research and development expense	$	7,040	$	3,949


	Six Months Ended June 30,
	2023		2022

Cash flow from operating activities

Net loss	$	(9,507)	$	(6,367)

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

Stock-based compensation		376		430
Amortization of right of use assets		47		45
Depreciation		44		43
(Increase) decrease in operating assets
Prepaid drug product		2,518		(1,624)
Other current assets		(102)		451
Increase (decrease) in operating liabilities
Accounts payable and accrued expenses		(263)		343
Lease liabilities		(53)		(50)

Net cash used in operating activities		(6,940)		(6,729)

Cash flow from investing activities

Purchases of furniture, fixtures & equipment		—		(21)

Net cash used in investing activities		—		(21)

Net decrease in cash		(6,940)		(6,750)

Cash, beginning of period		10,384		23,774

Cash, end of period	$	3,444	$	17,024

Supplemental disclosure of non-cash activities

Non-cash operating activities
Right of use asset recognized in exchange for lease obligation	$	—	$	85

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