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 September 30, 2021

☐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 November 5, 2021, the Company had 7,160,164 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 as of the fiscal year ended December 31, 2020, 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:

●the impact, risks and uncertainties related to COVID-19 and actions taken by governmental authorities or others in connection therewith;

●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;

●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;

●our ability to adequately protect the intellectual property of our drug candidates;

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●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; and

●our ability to 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, 2020, “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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		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

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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)

(Unaudited)


	As of September 30,		As of December 31,
	2021		2020

Assets

Current assets
Cash	$	26,601	$	13,755
Prepaid drug product		2,113		1,273
Other current assets		1,519		928
Total current assets		30,233		15,956

Fixed assets
Furniture, fixtures & equipment		1,076		1,029
Less accumulated depreciation		(854)		(798)
		222		231

Right of use operating assets		225		288

Total Assets	$	30,680	$	16,475

Liabilities & Shareholders' Equity

Current liabilities
Accounts payable	$	417	$	100
Accrued expenses		657		975
Current portion of lease liabilities		88		94
Total current liabilities		1,162		1,169

Noncurrent lease liabilities		172		236

Total Liabilities		1,334		1,405

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; 7,160 and 4,542 shares issued and outstanding, respectively		7		5

Additional paid in capital		102,884		82,286
Accumulated deficit		(73,545)		(67,221)

Total shareholders' equity		29,346		15,070

Total Liabilities & Shareholders' Equity	$	30,680	$	16,475

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 September 30,				Nine Months Ended September 30,
	2021		2020		2021		2020

Operating expenses

Research and development	$	981	$	2,000	$	3,002	$	5,038
General and administrative		1,088		970		3,324		3,319

Total operating expenses		2,069		2,970		6,326		8,357

Net operating loss	$	(2,069)	$	(2,970)	$	(6,326)	$	(8,357)

Other income
Interest income		—		2		2		25

Total other income		—		2		2		25

Net loss	$	(2,069)	$	(2,968)	$	(6,324)	$	(8,332)

Net loss per share, basic and diluted	$	(0.29)	$	(0.80)	$	(0.96)	$	(2.26)
Basic and diluted weighted average number of common shares outstanding		7,038		3,692		6,578		3,692

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)


	Nine Months Ended September 30,
	2021		2020

Cash flow from operating activities

Net loss	$	(6,324)	$	(8,332)

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

Stock-based compensation		591		432
Amortization of right of use assets		63		58
Depreciation		56		54
(Increase) decrease in operating assets
Prepaid drug product		(840)		(204)
Other current assets		(591)		(489)
Increase (decrease) in operating liabilities
Accounts payable and accrued expenses		(1)		176
Lease liabilities		(70)		(63)

Net cash used in operating activities		(7,116)		(8,368)

Cash flow from investing activities

Purchases of furniture, fixtures & equipment		(47)		—

Net cash used in investing activities		(47)		—

Cash flow from financing activities

Net proceeds from sale of common stock		15,852		—
Net proceeds from exercise of warrants		4,157		—

Net cash provided by financing activities		20,009		—

Net increase (decrease) in cash		12,846		(8,368)

Cash, beginning of period		13,755		20,426

Cash, end of period	$	26,601	$	12,058

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 June 30, 2020	3,692	$	4	$	77,710	$	(61,703)	$	16,011

Stock-based compensation	—		—		143		—		143

Net loss	—		—		—		(2,968)		(2,968)

Balance at September 30, 2020	3,692	$	4	$	77,853	$	(64,671)	$	13,186

Balance at June 30, 2021	6,960	$	7	$	101,223	$	(71,476)	$	29,754

Issuance of common stock, net of fees	200		—		1,399		—		1,399

Stock-based compensation	—		—		262		—		262

Net loss	—		—		—		(2,069)		(2,069)

Balance at September 30, 2021	7,160	$	7	$	102,884	$	(73,545)	$	29,346


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

Balance at December 31, 2019	3,692	$	4	$	77,421	$	(56,339)	$	21,086

Stock-based compensation	—		—		432		—		432

Net loss	—		—		—		(8,332)		(8,332)

Balance at September 30, 2020	3,692	$	4	$	77,853	$	(64,671)	$	13,186

Balance at December 31, 2020	4,542	$	5	$	82,286	$	(67,221)	$	15,070

Issuance of common stock, net of fees	2,189		2		15,850		—		15,852

Exercise of warrants, net of fees	429		—		4,157		—		4,157

Stock-based compensation	—		—		591		—		591

Net loss	—		—		—		(6,324)		(6,324)

Balance at September 30, 2021	7,160	$	7	$	102,884	$	(73,545)	$	29,346

SEE ACCOMPANYING NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

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BIO-PATH HOLDINGS, INC.

Notes to the Unaudited Condensed Consolidated Financial Statements

Unless the context requires otherwise, references in these Notes to the Condensed Consolidated Financial Statements 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.”

The accompanying unaudited condensed interim financial statements have been prepared in conformity with the authoritative U.S. generally accepted accounting principles (GAAP) for interim financial information and in accordance with the instructions to Form 10-Q pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and, therefore, do not include all information and footnotes required by GAAP for complete consolidated financial statements. In the opinion of management, all adjustments considered necessary for a fair presentation of the results of operations and financial position have been included and all such adjustments are of a normal recurring nature. The unaudited quarterly financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Annual Report on Form 10-K of the Company as of and for the fiscal year ended December 31, 2020. The results of operations for the period ended September 30, 2021, are not necessarily indicative of the results for a full-year period.

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, incorporated inside of a lipid bilayer having neutral charge. The Company believes this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, the DNAbilize® delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. Through testing in numerous animal studies and treatment in over 80 patients, the Company’s DNAbilize® drug candidates have demonstrated an excellent safety profile. DNAbilize® is a registered trademark of the Company. Using DNAbilize® as a platform for drug development and manufacturing, the Company currently has four antisense drug candidates in development to treat at least five different cancer disease indications.

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.

2. Significant Accounting Policies

Net Loss Per Share – Basic net loss per common share is computed by dividing the net loss for the period by the weighted average number of shares of common stock outstanding during the period. Although there were warrants and stock options outstanding as of September 30, 2021 and 2020, no potential common shares are included in the computation of any diluted per share amount, as they would be antidilutive. Consequently, diluted net loss per share as presented in the condensed consolidated financial statements is equal to basic net loss per share for the three and nine months ended September 30, 2021 and 2020. The calculation of diluted earnings per share for 2021 did not include 485,908 shares and 429,791 shares issuable pursuant to the exercise of outstanding common stock options and warrants, respectively, as of September 30, 2021 as the effect would be antidilutive. The calculation of diluted earnings

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per share for 2020 did not include 274,008 shares and 858,698 shares issuable pursuant to the exercise of outstanding common stock options and warrants, respectively, as of September 30, 2020 as the effect would be antidilutive.

Fair Value - The fair values of cash and cash equivalents, accounts payable and accrued liabilities approximate their carrying values because of the short-term maturities of these instruments.

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 $1.3 million as of December 31, 2020 pursuant to drug supply contracts for the manufacture and delivery of prexigebersen for testing in a Phase 2 clinical trial and BP1002 for testing in a Phase 1 clinical trial. The Company recognized certain expenses and incurred additional installment costs during the first nine months of 2021, with advanced payments remaining to be expensed totaling $2.1 million as of September 30, 2021.

4. Other Current Assets

As of September 30, 2021, other current assets included prepaid expenses of $1.5 million, comprised primarily of prepayments of $1.0 million made for the Company’s clinical trials for BP1002 in lymphoma, prexigebersen in AML and prexigebersen-A in solid tumors as well as prepaid insurance of $0.4 million and prepaid expenses related to preclinical studies of $0.1 million. As of December 31, 2020, other current assets included prepaid expenses of $0.9 million, comprised primarily of prepayments of $0.6 million made for the Company’s clinical trials for BP1002 in lymphoma and prexigebersen-A in solid tumors as well as prepaid insurance of $0.3 million.

5. Accounts Payable

As of September 30, 2021, current liabilities included accounts payable of $0.4 million, comprised primarily of amounts owed for drug supply manufacturing of $0.3 million and legal and patent fees of $0.1 million. As of December 31, 2020, current liabilities included accounts payable of $0.1 million, comprised primarily of investor relations expenses and legal and patent fees of $0.1 million.

6. Accrued Expense

As of September 30, 2021, current liabilities included accrued expenses of $0.7 million, comprised primarily of accrued employee vacation and bonus expenses of $0.3 million, manufacturing and testing services of $0.1 million, professional and consulting fees of $0.1 million, preclinical study expenses of $0.1 million and other accrued expenses of $0.1 million. As of December 31, 2020, current liabilities included accrued expenses of $1.0 million, comprised primarily of expenses related to the Company’s clinical trial for prexigebersen in AML of $0.4 million, accrued employee vacation and bonus expenses of $0.4 million, manufacturing expenses of $0.1 million and other accrued expenses of $0.1 million.

7. Stockholders’ Equity

Issuances of Common Stock - On February 16, 2021, the Company entered into a placement agency agreement with Roth Capital Partners, LLC relating to a public offering of 1,710,600 shares of its common stock for gross proceeds of approximately $13.0 million under the Company’s shelf registration statement on Form S-3 (File No. 333-231537) (the “2019 Shelf Registration Statement”), which was declared effective by the SEC on June 5, 2019 (the “2021 Public Offering”). In addition, on February 16, 2021, the Company entered into a securities purchase agreement with certain institutional investors pursuant to which the Company agreed to sell an aggregate of 1,650,000 shares of its common stock in the 2021 Public Offering to such investors. The 2021 Public Offering closed on February 18, 2021. The net proceeds from the offerings, after deducting the placement agent’s fees and expenses and the Company’s offering expenses, were approximately $12.2 million.

During the nine months ended September 30, 2021, the Company issued an aggregate of 428,907 shares of its common stock pursuant to the exercise of warrants at a weighted average exercise price of approximately $9.71 per share. The net proceeds to the Company from the exercise of the warrants were approximately $4.2 million.

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At-The-Market Offering Agreement - On July 13, 2020, the Company entered into an At-The-Market Offering Agreement (the “Offering Agreement”) with H. C. Wainwright & Co., LLC (“Wainwright”), as sales agent and/or principal, pursuant to which the Company may offer and sell, from time to time, through or to Wainwright, shares of the Company’s common stock. Sales of shares of common stock under the Offering Agreement were previously made pursuant to the 2019 Shelf Registration Statement and a related prospectus supplement filed with the SEC on July 14, 2020, for an aggregate offering price of up to $7.0 million. From and after August 18, 2021, sales of shares of common stock under the Offering Agreement will be made pursuant to the 2019 Shelf Registration Statement and a related prospectus supplement filed with the SEC on August 18, 2021, for an aggregate offering price of up to $10.0 million. Under the Offering Agreement, Wainwright may sell shares by any method deemed to be an “at the market” offering as defined in Rule 415 under the Securities Act of 1933, as amended. The Company will pay Wainwright a commission of 3% of the aggregate gross proceeds from each sale of shares under the Offering Agreement and has agreed to provide Wainwright with customary indemnification and contribution rights. The Company has also agreed to reimburse Wainwright for certain specified expenses.

During the nine months ended September 30, 2021, the Company offered and sold 478,800 shares of its common stock under the Offering Agreement for net proceeds of approximately $3.7 million.

Stockholders’ Equity totaled $29.3 million as of September 30, 2021 compared to $15.1 million as of December 31, 2020. There were 7,160,164 shares of common stock issued and outstanding as of September 30, 2021. There were no shares of preferred stock issued and outstanding as of September 30, 2021.

8. Stock-Based Compensation Plan

The 2017 Plan – On December 21, 2017, the Company’s stockholders approved the Bio-Path Holdings, Inc. 2017 Stock Incentive Plan (as amended, the “2017 Plan”), which replaced the First Amended 2007 Stock Incentive Plan, as amended (the “2007 Plan”). The 2007 Plan expired by its terms in January 2018, and no awards were made under the 2007 Plan from the approval of the 2017 Plan on December 21, 2017 until the expiration of the 2007 Plan. The 2017 Plan provides for the grant of Incentive Stock Options, Non-Qualified Stock Options, Restricted Shares, Restricted Share Units, Stock Appreciation Rights, Performance-Based Awards and other stock-based awards, or any combination of the foregoing to the Company’s employees, non-employee directors and consultants. On December 19, 2019, the Company’s stockholders approved an amendment to the 2017 Plan to increase the number of shares reserved for grant and issuance pursuant to the 2017 Plan by 600,000 shares to 660,000 shares. Under the 2017 Plan, the exercise price of awards is determined by the Board of Directors or the compensation committee of the Board of Directors, and for options intended to qualify as qualified Incentive Stock Options, may not be less than the fair market value as determined by the closing stock price at the date of the grant. Each option and award under the 2017 Plan shall vest and expire as determined by the Board of Directors or the compensation committee. Options expire no later than ten years from the date of grant. All grants provide for accelerated vesting if there is a change of control, as defined in the 2017 Plan.

Stock-based compensation expense for the three months ended September 30, 2021 and 2020 was $0.3 million and $0.1 million, respectively. Of these amounts, stock-based compensation expense for personnel involved in the Company’s general and administrative activities for the three months ended September 30, 2021 and 2020 was $0.2 million and $0.1 million, respectively. Stock-based compensation expense for personnel involved in the Company’s research and development activities for the three months ended September 30, 2021 and 2020 was $46,000 and $27,000, respectively.

Stock-based compensation expense for the nine months ended September 30, 2021 and 2020 was $0.6 million and $0.4 million, respectively. Of these amounts, stock-based compensation expense for personnel involved in the Company’s general and administrative activities for the nine months ended September 30, 2021 and 2020 was $0.5 million and $0.4 million, respectively. Stock-based compensation expense for personnel involved in the Company’s research and development activities for each of the nine months ended September 30, 2021 and 2020 was $0.1 million.

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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 nine months ended September 30, 2021 and 2020, respectively:


	2021		2020
Risk-free interest rate	1.15	%	0.50	%
Expected volatility	128	%	122	%
Expected term in years	6.0		6.0
Dividend yield	—	%	—	%

The following summary represents option activity under the Company’s stock-based compensation plans for the nine months ended September 30, 2021:


		Weighted-
		Average
		Exercise
	Options	Price
	(in thousands)
Outstanding at December 31, 2020	274	$	20.57
Granted	212		7.02
Outstanding at September 30, 2021

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