dare-20250930

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)


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

For the quarterly period ended September 30, 2025


☐			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: 001-36395

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	DARÉ BIOSCIENCE, INC. (Exact Name of Registrant as Specified in its Charter)
Delaware (State or Other Jurisdiction of Incorporation)		20-4139823 (IRS Employer Identification No.)

3655 Nobel Drive, Suite 260 San Diego, CA (Address of Principal Executive Offices)	(858) 926-7655 (Registrant’s telephone number, including area code)	92122 (Zip Code)

(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock	DARE	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 x No o

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 x No o

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 pursuant to Section 13(a) of the Exchange Act. o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No x

As of November 12, 2025, 14,289,229 shares of the Registrant’s Common Stock, par value $0.0001, were issued and outstanding.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q, in particular “Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations,” of Part I. Financial Information, and the information incorporated by reference herein contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this report, including statements regarding our strategy, future operations, future financial position, projected revenue, funding and expenses, prospects, plans and objectives of management, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” "can," “plan,” “potential,” “predict,” “seek,” "pursue," “should,” “would,” “accelerate,” "project,” “target,” “aim,” or the negative version of these words and similar expressions.

Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including those factors described in Part II, Item 1A, "Risk Factors", in this report, and elsewhere in this report. Given these uncertainties, you should not place undue reliance on any forward-looking statement. The following factors are among those that may cause such differences:

•Inability to raise additional capital, under favorable terms or at all, or generate sufficient revenue from our Section 503B compounding and consumer health products business strategies to fund our operating needs and continue as a going concern;

•Dependence on grants and other financial awards from governmental entities and a private foundation to advance the development of several of our product candidates;

•Inexperience, as a company, in and lack of infrastructure for commercializing products;

•Reliance on third parties to execute our operating plan and business strategy, including to commercialize or assist us in commercializing products and conduct or assist us in conducting clinical and nonclinical studies of our product candidates, and delays or difficulties in establishing and maintaining agreements with third parties on a timely basis or on acceptable terms, or at all, and obtaining expected performance from third parties;

•The number and scope of product development programs we pursue;

•Difficulties or delays in commencement or completion, or the termination or suspension, of our current or planned clinical or preclinical studies;

•Clinical trial outcomes and results of preclinical development;

•Failure to complete development of our product candidates or submit and obtain United States Food and Drug Administration, or FDA, or foreign regulatory authority approval for our product candidates on projected timelines or budgets, or at all;

•Challenges and delays in obtaining timely supplies of our product candidates, including their components as well as the finished product, in the quantities needed in accordance with current good manufacturing practices, our specifications and other applicable requirements;

•The removal of sildenafil citrate or any other bulk drug substance needed to compound the compounded drugs that we seek to make available under Section 503B of the Federal Food, Drug, and Cosmetic Act, or FDCA, from the FDA’s list of bulk drug substances that can be compounded under Section 503B;

•The degree of market demand and acceptance achieved by any product we or one of our licensees or collaborators brings to market;

•A change in the laws or regulations related to compounded drugs under Section 503B of the FDCA or consumer health products;

•Termination by a collaborator of our respective out-license agreements for commercialization of XACIATO® (clindamycin phosphate) vaginal gel 2%, or XACIATO, and Ovaprene®, or, in the case of Ovaprene, a decision by the collaborator not to make the license grant fully effective following its review of the results of the ongoing pivotal clinical trial of Ovaprene;

•The timing and amount of future royalty, milestone or other payments to us, if any, under our out-license agreement for Ovaprene, and of upside-sharing milestone payments from XOMA under our traditional and synthetic royalty purchase agreements, if any;

•The terms and conditions of any future strategic collaborations relating to our product candidates;

•Coverage and reimbursement levels for XACIATO and any future product by government health care programs, private health insurance companies and other third-party payors;

•Our loss of, or inability to attract, key personnel;

•A change in the FDA's prior determination that the Center for Devices and Radiological Health would lead the review of a premarket approval application for potential marketing approval of Ovaprene;

•A change in regulatory requirements for our product candidates, including the development pathway pursuant to Section 505(b)(2) of the FDCA, or the FDA's 505(b)(2) pathway;

•Unfavorable differences between preliminary, interim or topline clinical study data reported by us and final study results;

•Communication from the FDA or another regulatory authority, including a complete response letter, that such agency does not accept or agree with our assumptions, estimates, calculations, conclusions or analyses of clinical or nonclinical study data regarding a product candidate, or that such agency interprets or weighs the importance of study data differently than we have in a manner that negatively impacts the candidate's prospects for regulatory approval in a timely manner, or at all;

•Failure to select product candidates that capitalize on the most scientifically, clinically or commercially promising or profitable indications or therapeutic areas within women's health including due to our limited financial resources;

•Loss or impairment of our in-licensed rights to develop and commercialize our products and product candidates;

•The timing and amount of our payment and other obligations under our in-license and acquisition agreements for our products and product candidates;

•Developments by our competitors that make any product or potential product we develop less competitive or obsolete;

•Unfavorable or unanticipated macroeconomic factors, geopolitical events or conflicts, public health emergencies, or natural disasters;

•Weak interest in women's health relative to other healthcare sectors from the investment community or from pharmaceutical companies and other potential development and commercialization collaborators;

•Cyber-attacks, security breaches or similar events compromising our technology systems and data, our financial resources and other assets, or the technology systems and data of third parties on which we rely;

•Difficulty in introducing branded products in a market made up of generic products;

•Inability to adequately protect or enforce our, or our licensor’s, intellectual property rights;

•Lack of patent protection for the active ingredients in XACIATO and certain of the products and potential products we develop that expose them to competition from other formulations using the same active ingredients;

•Higher risk of failure associated with product candidates in preclinical stages of development that may lead investors to assign them little to no value and make these assets difficult to fund;

•Disputes or other developments concerning our intellectual property rights;

•Actual and anticipated fluctuations in our quarterly or annual operating results or results that differ from investors' expectations for such results;

•Failure to maintain the listing of our common stock on the Nasdaq Capital Market or another nationally recognized exchange;

•Price and volume fluctuations in the stock market, and in our stock in particular, which could cause investors to experience losses and subject us to securities class-action litigation;

•Development of safety, efficacy or quality concerns related to our products or product candidates (or third-party products or product candidates that share similar characteristics or drug substances), whether or not scientifically justified, leading to delays in or discontinuation of product development, product recalls or withdrawals, diminished sales, and/or other significant negative consequences;

•Product liability claims or governmental investigations;

•Changes in government laws and regulations in the United States and other jurisdictions, including laws and regulations governing the research, development, approval, clearance, manufacturing, supply, distribution, pricing and/or marketing of our products, product candidates and related intellectual property, health care information and data privacy and security laws, transparency laws and fraud and abuse laws, and the enforcement thereof affecting our business; and

•Increased costs as a result of operating as a public company, and substantial time devoted by our management to compliance initiatives and corporate governance practices.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.

All forward-looking statements in this report are current only as of the date of this report. We do not undertake any obligation to publicly update any forward-looking statement to reflect events or circumstances after the date on which any statement is made or to reflect the occurrence of unanticipated events, except as required by law.

TABLE OF CONTENTS


		Page
PART I. FINANCIAL INFORMATION

Item 1.	Condensed Consolidated Financial Statements (Unaudited)	1

Item 2.	Management's Discussion and Analysis of Financial Condition and Results of Operations	28

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	47

Item 4.	Controls and Procedures	47


PART II. OTHER INFORMATION

Item 1.	Legal Proceedings	48

Item 1A.	Risk Factors	48

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	49

Item 3.	Defaults Upon Senior Securities	49

Item 4.	Mine Safety Disclosures	49

Item 5.	Other Information	49

Item 6.	Exhibits	50

	SIGNATURES	51

PART I. FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements (Unaudited)

Daré Bioscience, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets


	September 30, 2025		December 31, 2024
	(unaudited)
Assets
Current assets
Cash and cash equivalents	$	23,075,261	$	15,698,174
Other receivables	369,157		229,982
Prepaid expenses	1,506,603		2,519,707
Other current assets	53,159		—
Total current assets	25,004,180		18,447,863
Property and equipment, net	1,657,255		1,335,732

Operating lease right-of-use assets	824,693		1,206,942
Finance lease right-of-use asset	2,244,073		—
Other non-current assets	1,018,373		1,110,594
Total assets	$	30,748,574	$	22,101,131
Liabilities and stockholders’ equity (deficit)
Current liabilities
Accounts payable	$	1,844,862	$	1,455,832
Accrued expenses	2,324,931		3,042,918

Deferred grant funding	14,557,265		16,561,625
Current portion of liability related to the sale of future royalties	10,542		4,054
Current portion of lease liabilities, operating	609,224		548,638
Current portion of lease liability, finance	1,869,570		—
Total current liabilities	21,216,394		21,613,067
Deferred revenue, non-current	1,000,000		1,000,000
Liability related to the sale of future royalties, net	5,220,525		4,745,770
Lease liabilities long-term, operating	288,566		754,383
Lease liability long-term, finance	165,186		—
Total liabilities	27,890,671		28,113,220
Commitments and contingencies (Note 9)
Stockholders' equity (deficit)
Preferred stock, $0.01 par value, 5,000,000 shares authorized; None issued and outstanding	—		—
Common stock, $0.0001 par value; 240,000,000 shares authorized; 13,929,502 and 8,700,386 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively	1,393		870
Additional paid-in capital	190,499,662		169,705,480
Accumulated other comprehensive loss	(395,966)		(428,809)
Accumulated deficit	(187,247,186)		(175,289,630)
Total stockholders' equity (deficit)	2,857,903		(6,012,089)
Total liabilities and stockholders' equity (deficit)	$	30,748,574	$	22,101,131

See accompanying notes.

Daré Bioscience, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

(Unaudited)


	Three months ended September 30,				Nine months ended September 30,
	2025		2024		2025		2024
Revenue
Royalty revenue	$	2,262	$	41,691	$	6,517	$	73,431
Total revenue	2,262		41,691		6,517		73,431
Operating expenses
General and administrative	2,499,242		2,041,268		7,186,272		7,159,979
Research and development	1,175,168		2,681,772		4,901,311		10,969,066
Royalty expense	—		—		—		7,674
Total operating expenses	3,674,410		4,723,040		12,087,583		18,136,719
Loss from operations	(3,672,148)		(4,681,349)		(12,081,066)		(18,063,288)
Other income (expense)
Sale of royalty and milestone rights, net	—		—		—

SEC Form 10-Q filed by Dare Bioscience Inc.