Bio-Path (BPTH) 10-Q11 May 232023 Q1 Quarterly reportFinancial data

Company Profile

Document and Entity Information

Document and Entity Information - shares	3 Months Ended
Document and Entity Information - shares	Mar. 31, 2023	May 05, 2023
Document and Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Mar. 31, 2023
Document Transition Report	false
Entity File Number	001-36333
Entity Registrant Name	BIO-PATH HOLDINGS INC
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	87-0652870
Entity Address, Address Line One	4710 Bellaire Boulevard, Suite 210
Entity Address, City or Town	Bellaire
Entity Address, State or Province	TX
Entity Address, Postal Zip Code	77401
City Area Code	832
Local Phone Number	742-1357
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	BPTH
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		7,960,164
Entity Central Index Key	0001133818
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q1
Current Fiscal Year End Date	--12-31
Amendment Flag	false

CONDENSED CONSOLIDATED BALANCE

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
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)
Furniture, fixtures & equipment, net	136	158
Right of use operating assets	175	198
Total Assets	11,102	15,971
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 7,160 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

CONDENSED CONSOLIDATED BALANC_2

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares shares in Thousands	Mar. 31, 2023	Dec. 31, 2022
CONDENSED CONSOLIDATED BALANCE SHEETS
Preferred Stock, par value	$ 0.001	$ 0.001
Preferred Stock, shares authorized	10,000	10,000
Preferred Stock, shares issued	0	0
Preferred Stock, shares outstanding	0	0
Common Stock, par value	$ 0.001	$ 0.001
Common Stock, shares authorized	200,000	200,000
Common Stock, shares issued	7,960	7,160
Common Stock, shares outstanding	7,960	7,160

CONDENSED CONSOLIDATED STATEMEN

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 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 (in dollars per share)	$ (0.66)	$ (0.47)
Weighted average number of common shares outstanding, basic (in shares)	7,960	7,160
Net loss per share, diluted (in dollars per share)	$ (0.66)	$ (0.47)
Weighted average number of common shares outstanding, diluted (in shares)	7,960	7,160

CONDENSED CONSOLIDATED STATEM_2

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Cash flow from operating activities
Net income loss	$ 5,273	$ 3,359
Adjustments to reconcile net loss to net cash used in operating activities
Stock-based compensation	206	217
Amortization of right of use assets	23	23
Depreciation	22	22
(Increase) decrease in operating assets
Prepaid drug product	1,191	(429)
Other current assets	(20)	433
Increase (decrease) in operating liabilities
Accounts payable and accrued expenses	224	591
Lease liabilities	(26)	(24)
Net cash used in operating activities	(3,653)	(2,526)
Cash flow from financing activities
Net (decrease) increase in cash	(3,653)	(2,526)
Cash, beginning of period	10,384	23,774
Cash, end of period	$ 6,731	21,248
Non-cash operating activities
Right of use asset recognized in exchange for lease obligation		$ 85

CONDENSED CONSOLIDATED STATEM_3

CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - USD ($) shares in Thousands, $ in Thousands	Common Stock	Additional Paid in Capital.	Accumulated Deficit	Total
Beginning Balance at Dec. 31, 2021	$ 7	$ 103,111	$ (77,661)	$ 25,457
Beginning Balance (in shares) at Dec. 31, 2021	7,160
Stock-based compensation		217		217
Net loss			(3,359)	(3,359)
Ending Balance at Mar. 31, 2022	$ 7	103,328	(81,020)	22,315
Ending Balance (in shares) at Mar. 31, 2022	7,160
Beginning Balance at Dec. 31, 2022	$ 8	105,695	(91,529)	14,174
Beginning Balance (in shares) at Dec. 31, 2022	7,960
Stock-based compensation		206		206
Net loss			(5,273)	(5,273)
Ending Balance at Mar. 31, 2023	$ 8	$ 105,901	$ (96,802)	$ 9,107
Ending Balance (in shares) at Mar. 31, 2023	7,960

Organization and Business

Organization and Business	3 Months Ended
Organization and Business	Mar. 31, 2023
Organization and Business
Organization and Business	1. Organization and Business The Company is a clinical and preclinical stage oncology-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, In vivo, 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. Effective December 31, 2014, the Company changed its 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. 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.

Significant Accounting Policies

Significant Accounting Policies	3 Months Ended
Significant Accounting Policies	Mar. 31, 2023
Significant Accounting Policies
Significant Accounting Policies	2. Significant Accounting Policies Net Loss Per Share – did not include 675,741 shares and 423,390 shares issuable pursuant to the exercise of outstanding common stock options and warrants, respectively, as of March 31, 2022 as the effect would be antidilutive. Liquidity - Fair Value -

Prepaid Drug Product

Prepaid Drug Product	3 Months Ended
Prepaid Drug Product	Mar. 31, 2023
Prepaid Drug Product
Prepaid Drug Product	3. Prepaid Drug Product Advance payments, including nonrefundable 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 $3.6 million as of December 31, 2022 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 three months of 2023, with advanced payments remaining to be expensed totaling $2.4 million as of March 31, 2023.

Other Current Assets

Other Current Assets	3 Months Ended
Other Current Assets	Mar. 31, 2023
Other Current Assets
Other Current Assets	4. Other Current Assets As of March 31, 2023, other current assets included prepaid expenses of $1.7 million, comprised primarily of prepayments of $1.4 million made for the Company’s clinical trials for BP1002 in separate clinical trials for lymphoma and AML, prexigebersen in AML as well as BP1001-A in solid tumors. Additionally, the Company had prepaid expenses related to its insurance policies of $0.2 million and preclinical studies of $0.1 million. As of December 31, 2022, other current assets included prepaid expenses of $1.6 million, comprised primarily of prepayments of $1.3 million made for the Company’s clinical trials for BP1002 in AML and lymphoma, BP1001-A in solid tumors and prexigebersen in AML as well as prepaid insurance of $0.3 million.

Accounts Payable

Accounts Payable	3 Months Ended
Accounts Payable	Mar. 31, 2023
Accounts Payable
Accounts Payable	5. Accounts Payable As of March 31, 2023, current liabilities included accounts payable of $0.8 million, comprised primarily of expenses related to drug manufacturing, development and testing services of $0.5 million and clinical trial expenses of $0.3 million. As of December 31, 2022, current liabilities included accounts payable of $0.7 million, comprised primarily of expenses related to drug manufacturing, development and testing services of $0.6 million and legal and patent fees of $0.1 million.

Accrued Expense

Accrued Expense	3 Months Ended
Accrued Expense	Mar. 31, 2023
Accrued Expense
Accrued Expense	6. Accrued Expense As of March 31, 2023, current liabilities included accrued expenses of $1.0 million, comprised primarily of accrued employee vacation and bonus expenses of $0.5 million, drug manufacturing development and testing services of $0.2 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. As of December 31, 2022, current liabilities included accrued expenses of $0.9 million, comprised primarily of accrued employee vacation and bonus expenses of $0.4 million, drug manufacturing development and testing services of $0.2 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.

Stockholders' Equity

Stockholders' Equity	3 Months Ended
Stockholders' Equity	Mar. 31, 2023
Stockholders' Equity
Stockholders' Equity	7. Stockholders’ Equity Issuances of Common Stock Stockholders’ Equity totaled $9.1 million as of March 31, 2023 compared to $14.2 million as of December 31, 2022. There were 7,960,164 shares of common stock issued and outstanding outstanding

Stock-Based Compensation Plan

Stock-Based Compensation Plan	3 Months Ended
Stock-Based Compensation Plan	Mar. 31, 2023
Stock-Based Compensation Plan
Stock-Based Compensation Plan	8. Stock-Based Compensation Plan The 2022 Plan ten Stock-based compensation expense for each of the three months ended March 31, 2023 and 2022 was $0.2 million. 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 March 31, 2023 and 2022 was $0.2 million. Stock-based compensation expense for personnel involved in the Company’s research and development activities for the three months ended March 31, 2023 and 2022 was $49,000 and $47,000, respectively. The Company utilized the Black-Scholes valuation model for estimating the fair value of the stock options granted, with the following weighted-average assumptions for options granted in the three months ended March 31, 2023 and 2022, respectively: 2023 2022 Risk-free interest rate (1) — % 2.43 % Expected volatility (1) — % 127 % Expected term in years (1) — 6.0 Dividend yield (1) — % — % (1) There were no options granted in the three months ended March 31, 2023. The following summary represents option activity under the Company’s stock-based compensation plans for the three months ended March 31, 2023: 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 As of March 31, 2023, 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, 2023 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 March 31, 2023. This amount changes based on the fair value of the Company’s stock. As of March 31, 2023, unamortized stock-based compensation expense for all outstanding options was $1.1 million, which is expected to be recognized over a weighted average vesting period of 2.1 years.

Commitments and Contingencies

Commitments and Contingencies	3 Months Ended
Commitments and Contingencies	Mar. 31, 2023
Commitments and Contingencies
Commitments and Contingencies	9. Commitments and Contingencies Drug Supplier Project Plan

Significant Accounting Polici_2

Significant Accounting Policies (Policies)	3 Months Ended
Significant Accounting Policies (Policies)	Mar. 31, 2023
Significant Accounting Policies
Net Loss Per Share	Net Loss Per Share – did not include 675,741 shares and 423,390 shares issuable pursuant to the exercise of outstanding common stock options and warrants, respectively, as of March 31, 2022 as the effect would be antidilutive.
Liquidity	Liquidity -
Fair Value	Fair Value -

Stock-Based Compensation Plan (

Stock-Based Compensation Plan (Tables)	3 Months Ended
Stock-Based Compensation Plan (Tables)	Mar. 31, 2023
Stock-Based Compensation Plan
Summary of weighted-average assumptions	The Company utilized the Black-Scholes valuation model for estimating the fair value of the stock options granted, with the following weighted-average assumptions for options granted in the three months ended March 31, 2023 and 2022, respectively: 2023 2022 Risk-free interest rate (1) — % 2.43 % Expected volatility (1) — % 127 % Expected term in years (1) — 6.0 Dividend yield (1) — % — %
Schedule of option activity under stock-based compensation plans	The following summary represents option activity under the Company’s stock-based compensation plans for the three months ended March 31, 2023: 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

Significant Accounting Polici_3

Significant Accounting Policies (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022	Dec. 31, 2022
Significant Accounting Policies [Line Items]
Cash	$ 6,731		$ 10,384
Warrant
Significant Accounting Policies [Line Items]
Antidilutive securities excluded from computation of earnings per share, amount	1,200,531	423,390
Stock Options
Significant Accounting Policies [Line Items]
Antidilutive securities excluded from computation of earnings per share, amount	657,408	675,741

Prepaid Drug Product (Details)

Prepaid Drug Product (Details) - USD ($) $ in Millions	Mar. 31, 2023	Dec. 31, 2022
Prepaid Drug Product
Prepaid drug product for testing		$ 3.6
Advanced payments remaining to be expensed	$ 2.4

Other Current Assets (Details)

Other Current Assets (Details) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Other prepaid expenses		$ 3,600
Other current assets	$ 1,664	1,644
Other Current Assets [Member]
Other prepaid expenses	1,700	1,600
Other Current Assets [Member] \| BP1002 in lymphoma, prexigebersen in AML and prexigebersen-A [Member]
Prepayments for clinical trials	1,400	1,300
Prepaid insurance	200	$ 300
Prepayments for preclinical studies	$ 100

Accounts Payable (Details)

Accounts Payable (Details) - USD ($) $ in Thousands	3 Months Ended	12 Months Ended
Accounts Payable (Details) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Accounts Payable [Line Items]
Accounts payable, current	$ 827	$ 667
Accounts Payable [Member]
Accounts Payable [Line Items]
Accounts payable, current	800	700
Drug manufacturing, development and testing services	500	600
Clinical trial expenses	$ 300
Legal and patent fees		$ 100

Accrued Expense (Details)

Accrued Expense (Details) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Accrued expense	$ 973	$ 909
Accrued Expenses
Accrued expense	1,000	900
Vacation and bonus expenses	500	400
Manufacturing and testing services	200
Professional and consulting fees	100	100
Legal and patent fees	100	100
Other expenses	$ 100	100
Manufacturing expenses		$ 200

Stockholders' Equity (Details)

Stockholders' Equity (Details) - USD ($) $ in Thousands	Nov. 09, 2022	Nov. 06, 2022	Mar. 31, 2023	Dec. 31, 2022	Mar. 31, 2022	Dec. 31, 2021
Shareholders Equity [Line Items]
Stockholders' Equity total amount			$ 9,107	$ 14,174	$ 22,315	$ 25,457
Common Stock, shares issued			7,960,000	7,160,000
Common Stock, shares outstanding			7,960,000	7,160,000
Preferred Stock, shares issued			0	0
Preferred Stock, shares outstanding			0	0
Common Stock
Shareholders Equity [Line Items]
Stockholders' Equity total amount			$ 8	$ 8	$ 7	$ 7
2022 Registered Direct Offering [Member]
Shareholders Equity [Line Items]
Net proceeds from sale of common stock		$ 2,000
2022 Registered Direct Offering [Member] \| Common Stock
Shareholders Equity [Line Items]
Shares issued (in shares)		800,000
2022 Private Placement [Member]
Shareholders Equity [Line Items]
Net proceeds	$ 1,700
2022 Private Placement [Member] \| Warrant
Shareholders Equity [Line Items]
Shares available for purchase from warrants issued	800,000
At-The-Market Offering Agreement [Member]
Shareholders Equity [Line Items]
Stockholders' Equity total amount			$ 9,100	$ 14,200
At-The-Market Offering Agreement [Member] \| Common Stock
Shareholders Equity [Line Items]
Common Stock, shares issued			7,960,164
Common Stock, shares outstanding			7,960,164
At-The-Market Offering Agreement [Member] \| Preferred Stock
Shareholders Equity [Line Items]
Preferred Stock, shares issued			0
Preferred Stock, shares outstanding			0

Stock-Based Compensation Plan -

Stock-Based Compensation Plan - Narrative (Details) - USD ($)	3 Months Ended		12 Months Ended
	Mar. 31, 2023	Mar. 31, 2022	Dec. 31, 2022
Stock Based Compensation Plans [Line Items]
Stock-based compensation expense	$ 200,000	$ 200,000
Aggregate intrinsic value of outstanding stock options	0
Unamortized stock-based compensation expense for outstanding options	$ 1,100,000
Weighted average vesting period	2 years 1 month 6 days
2022 Stock Incentive Plan
Stock Based Compensation Plans [Line Items]
Common stock shares reserved for future issuance			1,300,000
2022 Stock Incentive Plan \| Maximum
Stock Based Compensation Plans [Line Items]
Expiration period (in years)			10 years
Research and Development Expenses
Stock Based Compensation Plans [Line Items]
Stock-based compensation expense	$ 49,000	47,000
General and Administrative Expenses
Stock Based Compensation Plans [Line Items]
Stock-based compensation expense	$ 200,000	$ 200,000

Stock-Based Compensation Plan_2

Stock-Based Compensation Plan - Weighted Average Assumptions (Details)	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Stock-Based Compensation Plan
Risk-free interest rate		2.43%
Expected volatility		127%
Expected term in years		6 years
Dividend yield	0%	0%

Stock-Based Compensation Plan_3

Stock-Based Compensation Plan - Option Activity Under Plan (Details)	3 Months Ended
	Mar. 31, 2023 $ / shares shares
Stock-Based Compensation Plan
Outstanding	658,000
Granted	0
Outstanding	658,000
Vested and expected to vest	640,000
Exercisable	393,000
Weighted-Average Exercise Price, Outstanding \| $ / shares	$ 11.67
Weighted-Average Exercise Price, Outstanding \| $ / shares	11.67
Weighted - Average Exercise Price, Vested and expected to vest \| $ / shares	11.85
Weighted-Average Exercise Price, Exercisable \| $ / shares	$ 16.08

Commitments and Contingencies (

Commitments and Contingencies (Details) $ in Millions	3 Months Ended
Commitments and Contingencies (Details) $ in Millions	Mar. 31, 2023 USD ($)
Product Liability Contingency [Line Items]
Other commitments, due in next twelve months	$ 2.1
Drug Supplier Project Plan
Product Liability Contingency [Line Items]
Other commitments	$ 2.1
Term over which commitment expenses are incurred	12 months
Manufacture of Grb2
Product Liability Contingency [Line Items]
Other commitments	$ 1.8
Manufacturer of Prexigebersen
Product Liability Contingency [Line Items]
Other commitments	0.2
Testing Services
Product Liability Contingency [Line Items]
Other commitments	$ 0.1