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Daré Bioscience (NASDAQ: DARE) posts Q2 2026 loss, advances women’s health launches

(High)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Daré Bioscience reported second quarter 2026 results and highlighted a shift toward commercialization in women’s health. The company launched Flora Sync LF5, its first directly commercialized product, which began generating revenue in July, and is preparing for national dispensing of DARE to PLAY Sildenafil Cream with initial revenue expected in the third quarter of 2026. The pipeline advanced with positive interim Phase 3 Ovaprene results and initiation of the DARE-HPV Phase 2 study, supported by significant grant funding recorded as contra-R&D expense.

For the quarter ended June 30, 2026, total revenue was $187,546 versus $(21,172) a year earlier, while net loss narrowed to $2,982,773 from $4,016,483. Cash and cash equivalents were $12.6 million, down from $24.7 million at December 31, 2025. Working capital moved to a $0.2 million deficit and stockholders’ equity to a $0.6 million deficit, reflecting balance sheet pressure as the company invests in commercialization. Risk disclosures emphasize the need for additional capital to continue as a going concern and the possibility of Nasdaq Capital Market suspension or delisting.

Positive

  • Commercial inflection begins: launch of Flora Sync LF5 in July 2026 and expected DARE to PLAY Sildenafil Cream revenue in Q3 2026 support a planned multi-product revenue profile across 2026–2027.
  • Pipeline and non-dilutive funding: positive interim Phase 3 Ovaprene results, initiation of the DARE-HPV Phase 2 study, and approximately $4.7 million in contra-R&D expenses from grants support ongoing development.

Negative

  • Balance sheet deterioration: cash fell to $12.6 million from $24.7 million at year-end 2025, with a $0.2 million working capital deficit and $0.6 million stockholders’ deficit as of June 30, 2026.
  • Going-concern and listing risks: disclosures highlight dependence on raising additional capital to continue as a going concern and the risk of suspension or delisting of common stock from the Nasdaq Capital Market.

Filing Explained

Grant offsets reduced reported second-quarter R&D expense, making the $0.2 million line an incomplete measure of gross program spending.

This Form 8-K reports the company’s quarterly results through a furnished press-release exhibit; that exhibit is not treated as filed under the Exchange Act, so its statements have the disclosure status specified in the filing.

Grant funding is recorded as contra-R&D expense as related costs are incurred, reducing the reported second-quarter R&D line to about $0.2 million while about $4.7 million of contra-R&D expense offset direct program costs; the reported line therefore is not a standalone measure of gross program investment.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Q2 2026 Revenue $187,546 Total revenue for the three months ended June 30, 2026
Q2 2026 Net Loss $2,982,773 Net loss for the three months ended June 30, 2026
Loss per Share $0.20 Loss per common share, basic and diluted, for Q2 2026
Cash and Cash Equivalents $12,617,594 Cash and cash equivalents as of June 30, 2026
Working Capital $(236,457) Working capital deficit as of June 30, 2026
Total Assets $22,370,109 Total assets as of June 30, 2026
Stockholders’ (Deficit) Equity $(560,100) Total stockholders’ deficit as of June 30, 2026
Contra-R&D Expense $4,700,000 Approximate total contra-R&D expense for Q2 2026 from grants
contra-R&D expenses financial
"Total contra-R&D expense was approximately $4.7 million for the three months ended June 30, 2026"
Accounting entry that reduces reported research and development (R&D) expense by recording offsets such as government grants, customer reimbursements, tax credits, or the reversal of prior R&D charges. Think of it like a store coupon applied against a purchase: the headline R&D spending is lowered on the income statement by these contra entries, which can change how profitable a period looks without altering underlying R&D activity. Investors use it to separate gross R&D effort from net cost impacts on earnings and cash flow.
working capital deficit financial
"a working capital deficit, which is calculated as current assets minus current liabilities"
A working capital deficit occurs when a company's short-term obligations—like bills, supplier payments and near-term debt—are larger than its readily available short-term resources such as cash, money expected from customers, and inventory that can be sold. Like a household whose monthly bills exceed its checking account, it signals potential difficulty paying immediate expenses, which matters to investors because it raises the chance the company will need outside financing or cut operations, affecting risk and value.
Section 503B-registered outsourcing facilities regulatory
"reliance on Section 503B-registered outsourcing facilities and other third parties to bring DARE to PLAY"
FDA 505(b)(2) regulatory pathway regulatory
"The term FDA 505(b)(2) regulatory pathway refers to Section 505(b)(2) of the FDCA"
non-cash royalty revenues financial
"partially offset by a decrease in non-cash royalty revenues related to XACIATO"
Revenue $187,546 compared with $(21,172) in the three months ended June 30, 2025
Net loss $2,982,773 compared with $4,016,483 in the three months ended June 30, 2025
Loss per share $0.20 compared with $0.45 in the three months ended June 30, 2025
Cash and cash equivalents $12,617,594 compared with $24,711,356 at December 31, 2025
Guidance

The company expects revenue from Flora Sync LF5 beginning in July 2026, DARE to PLAY Sildenafil Cream in the third quarter of 2026, and DARE to estradiol and progesterone intravaginal ring in 2027, building toward a multi-product revenue profile.

FAQ

How did Daré Bioscience (DARE) perform financially in Q2 2026?

Daré Bioscience reported Q2 2026 revenue of $187,546 and a net loss of $2,982,773, compared with a net loss of $4,016,483 in Q2 2025, indicating a narrower loss year over year.

What is Daré Bioscience’s cash position and working capital as of June 30, 2026?

As of June 30, 2026, Daré held $12,617,594 in cash and cash equivalents and reported a working capital deficit of $236,457, reflecting current liabilities slightly exceeding current assets.

What commercial milestones did Daré Bioscience (DARE) report for 2026?

Daré launched Flora Sync LF5, its first directly commercialized product, in July 2026 and expects initial revenue from DARE to PLAY Sildenafil Cream beginning in the third quarter of 2026, with additional product revenue targeted for 2027.

Which clinical programs are driving Daré Bioscience’s women’s health pipeline?

Key programs include Ovaprene with positive interim Phase 3 results, the DARE-HPV Phase 2 study, and additional clinical and grant-supported programs such as investigational Sildenafil Cream and DARE-PTB1 and DARE-LARC1, addressing significant unmet needs.

How much did Daré Bioscience (DARE) spend on operating expenses in Q2 2026?

Total operating expenses were $2,835,637 in Q2 2026, including $2,593,671 of selling, general and administrative expenses and $241,966 of research and development expenses, before considering contra-R&D offsets from grant funding.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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false 0001401914 0001401914 2026-08-13 2026-08-13 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): August 13, 2026

 

DARÉ BIOSCIENCE, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   001-36395   20-4139823
(State or other jurisdiction
of incorporation)
  (Commission
File Number)
  (I.R.S. Employer
Identification No.)

 

3655 Nobel Drive, Suite 260
San Diego
, CA 92122
(Address of Principal Executive Offices and Zip Code)

 

Registrant’s telephone number, including area code: (858) 926-7655

 

Not Applicable
(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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 is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

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. ☐

 

 

 

 
 

 

Item 2.02 Results of Operations and Financial Condition.

 

On August 13, 2026, Daré Bioscience, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2026, a copy of which is furnished as Exhibit 99.1 to this report.

 

The information in this Item 2.02 and in Exhibit 99.1 to this report is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information be deemed to be incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, whether made before or after the date hereof, regardless of any general incorporation by reference language in any such filing, except as the Company expressly sets forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Description
99.1   Press release issued on August 13, 2026
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

-2-
 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  DARÉ BIOSCIENCE, INC.
   
Dated: August 13, 2026 By: /s/ Sabrina Martucci Johnson
  Name: Sabrina Martucci Johnson
  Title: President and Chief Executive Officer

 

-3-

 

Exhibit 99.1

 

 

 

Daré Bioscience Reports Second Quarter 2026 Results and Highlights Commercial Inflection as Multi-Product Women’s Health Strategy Advances

 

Company launches Flora Sync LF5™, the company’s first directly commercialized product, began generating revenue in July

 

DARE to PLAY™ Sildenafil Cream progressing toward national dispensing and initial revenue in the third quarter of 2026, with prescriptions and preorders already being accepted

 

Building a commercial ecosystem to make it easier for women to discover, access and purchase products specifically designed for women

 

Clinical pipeline continues to advance, led by positive interim Phase 3 Ovaprene® results and initiation of the DARE-HPV Phase 2 study

 

Company to host conference call and webcast today, August 13, 2026, at 4:30 p.m. Eastern Time – Access the webcast here

 

SAN DIEGO, August 13, 2026 (GLOBE NEWSWIRE) — Daré Bioscience, Inc. (NASDAQ: DARE), a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions, today reported financial results for the quarter ended June 30, 2026, and provided a corporate update highlighting key milestones in its commercial evolution, including the launch of Flora Sync LF5, its first directly commercialized product. The Company also continued preparations for prescription dispensing of DARE to PLAY Sildenafil Cream and expanded its purpose-built commercial ecosystem.

 

Daré continued to advance its diversified development pipeline of women’s health products toward multiple anticipated clinical and regulatory milestones. The Company’s pipeline includes product candidates at various stages of development addressing significant unmet needs across women’s health. As these programs move through clinical development and regulatory review, they have the potential to broaden Daré’s future commercial portfolio, generate additional value-driving catalysts and provide a sustained pipeline of differentiated products for its growing commercial infrastructure.

 

 

 

 

 

 

“The launch of Flora Sync LF5, our first directly commercialized product, represents an important milestone in the strategy Daré has pursued since its founding, to bring to market evidence-based products specifically designed for women,” said Sabrina Martucci Johnson, President and Chief Executive Officer of Daré Bioscience. “With DARE to PLAY Sildenafil Cream nearing prescription dispensing, we are expanding our commercial portfolio while building the capabilities to make our products easier for women to discover, access and purchase. Our commercial platform is designed to support not only our initial launches, but also future products across our portfolio. By pairing a differentiated women’s health pipeline with a scalable path to market, we are building a strong foundation for sustainable, long-term growth.”

 

Daré is building a commercial platform that brings together evidence-based products, provider engagement, targeted digital marketing, telehealth services and the DARE Health Hub within a coordinated, data-driven model tailored to women’s health. These capabilities will allow the Company to reach women through multiple channels, facilitate a more seamless path from education to fulfillment, and generate insights that can inform customer acquisition and resource allocation. By applying the lessons from each launch across its broader portfolio, Daré is creating a repeatable, capital-efficient approach to commercialization.

 

Building Toward a Multi-Product Commercial Portfolio:

 

Launched Flora Sync LF5 through the DARE Health Hub, establishing the Company’s first direct-to-consumer product offering.
Continued preparations for DARE to PLAY Sildenafil Cream prescription dispensing, with nationwide prescription intake and early preorder activity underway through the DARE Health Hub.*
DARE to PLAY Sildenafil Cream prescription dispensing and initial product revenue expected to commence in Q3 2026.
Entered a strategic collaboration with MyMenopauseRx to connect women exploring DARE to PLAY Sildenafil Cream with a telehealth provider dedicated to perimenopause and menopause care and expand patient access and reach.
Continued optimizing provider engagement, digital marketing, telehealth and customer acquisition channels to support capital-efficient commercial growth.

 

 

 

 

 

 

DARE to RECLAIM – Estradiol plus Progesterone Monthly Hormone Therapy for Menopause*
   
Activities to support commercial availability through the 503B compounding pathway are underway, with prescription dispensing targeted to begin in 2027.
Working in parallel to advance an FDA 505(b)(2) regulatory pathway strategy.**

 

Pipeline Execution:

 

Ovaprene® - Investigational Hormone-Free Monthly Intravaginal Contraceptive
   
Reported positive interim results from the ongoing pivotal Phase 3 study and the independent Data Safety Monitoring Board’s recommendation that the study continue without modification.

 

DARE-HPV - Investigational Therapeutic with Potential to be the First for High-Risk HPV Infection

 

With funding from an ARPA-H award, initiated a Phase 2 study expected to enroll approximately 100 women with persistent high-risk human papillomavirus (HPV) infection. Topline results are expected in 2027.
Received a funding award notice for a second $1.0 million tranche from the National Institute of Allergy and Infectious Disease (NIAID), a division of the NIH, bringing the total funding award for the DARE-HPV program across the project period that began in December 2024 to $2.0 million.

 

“We are very pleased with the momentum across our development pipeline, including the recently reported positive interim results for Ovaprene and the initiation of the DARE-HPV Phase 2 study,” continued Ms. Johnson. “We are also making meaningful progress across our additional clinical and grant-supported programs, creating multiple opportunities for data, regulatory milestones and value creation. Each step brings us closer to delivering new options in areas of women’s health where significant needs remain unmet.”

 

Financial Results for Second Quarter 2026 and Highlights

 

Cash Position

 

As of June 30, 2026, Daré had approximately $12.6 million in cash and cash equivalents, and a working capital deficit, which is calculated as current assets minus current liabilities, including a deferred grant funding liability of approximately $15.0 million, of approximately $0.2 million.

 

 

 

 

 

 

Revenue

 

Total revenue for the three months ended June 30, 2026 was $0.2 million compared to $(0.02) million for the same period of the prior year. The increase is attributable to research and development (R&D) services revenues from agreements entered into with the Gates Foundation in September and October 2025, partially offset by a decrease in non-cash royalty revenues related to XACIATO®.

 

Cost of Revenues

 

Cost of revenues for the three months ended June 30, 2026, was $0.3 million with no comparable activity in the same period of the prior year. Cost of revenues related to the cost of performing R&D services under agreements entered into with the Gates Foundation in September and October 2025, and to expenses associated with medical education and awareness related to the commercialization of DARE to PLAY.

 

Operating Expenses

 

Selling, general and administrative expenses were approximately $2.6 million for the three months ended June 30, 2026, compared to approximately $2.4 million for the same period of the prior year. The year-over-year increase was primarily attributable to a non-cash write down of previously deferred equity offering costs.

 

R&D expenses were approximately $0.2 million for the three months ended June 30, 2026, compared to approximately $1.4 million for the same period of the prior year. The decrease of approximately $1.2 million was primarily related to an increase in contra R&D expenses for direct program costs, decreases in direct costs of several programs, driven by decreases in costs related to the Ovaprene Phase 3 clinical trial, the DARE-PTB1 program, and the DARE-LARC1 program, and a decrease in personnel-related costs. Such decreases were partially offset by increases in expenses related to DARE-HPV, investigational Sildenafil Cream, and DARE to PLAY Sildenafil Cream. Contra R&D expenses for the three months ended June 30, 2026 and 2025 primarily offset direct program costs for DARE-LARC1, Ovaprene and DARE-HPV. Daré recognizes amounts received under grant and governmental funding awards as “contra-R&D expenses,” meaning grant funding reduces R&D expenses in the statements of operations as the related costs are incurred over the grant period. Total contra-R&D expense was approximately $4.7 million for the three months ended June 30, 2026, compared to approximately $4.5 million for the same period of the prior year. Daré believes this dynamic is important to understand when evaluating the true scale of Daré’s R&D investment and capital efficiency.

 

 

 

 

 

Revenue Outlook

 

Daré began recording revenue from sales of Flora Sync LF5 in July 2026 and expects to begin recording revenue from sales of DARE to PLAY Sildenafil Cream in the third quarter of 2026. Revenue from DARE to RECLAIM estradiol and progesterone intravaginal ring is targeted to begin in 2027. Daré is building toward a multi-product revenue profile that diversifies and grows across 2026 and 2027.

 

Daré encourages investors to review the detailed discussion of its financial statements, financial condition, liquidity, capital resources and risk factors in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed today with the U.S. Securities and Exchange Commission (SEC).

 

Conference Call

 

Daré will host a conference call and live webcast today, August 13, 2026, at 4:30 p.m. Eastern Time to review its financial results for the quarter ended June 30, 2026, and to provide a company update.

 

To access the conference call via phone, dial (646) 307-1963 or (800) 715-9871 (toll-free). The conference ID number for the call is 3808585. The live webcast can be accessed under “Presentations, Events & Webcasts” in the Investors section of the company’s website at ir.darebioscience.com. Please log in approximately 5-10 minutes prior to the call to register and to download and install any necessary software. The webcast will be archived in the same section of the company’s website and available for replay for 90 days.

 

ABOUT DARÉ BIOSCIENCE, INC.

 

Daré Bioscience (NASDAQ: DARE) is a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions. Every innovation Daré advances is based in advanced science and backed by rigorous, peer-reviewed research. From contraception to menopause, sexual health to fertility, vaginal health to infectious disease, Daré is working to close critical gaps in care using science that serves her needs. For decades, women have been told to “wait it out” or “live with it,” while innovations that could improve their quality of life languish in the regulatory or funding pipeline. With growing awareness around menopause, sexual health, and vaginal health, the conversation is shifting. However, access to proven solutions is lagging. Daré is working to change that. Learn more at darebioscience.com.

 

 

 

 

 

 

FORWARD-LOOKING STATEMENTS

 

Daré cautions you that all statements, other than statements of historical facts, contained in this press release, 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,” “plan,” “potential,” “prepare,” “progress,” “seek,” “should,” “would,” “build” or the negative version of these words and similar expressions.

 

In this press release, forward-looking statements include, but are not limited to, statements relating to: Daré’s commercial strategy and plans; the capabilities of Daré’s commercial infrastructure; the timing of DARE to PLAY and DARE to RECLAIM prescription dispensing and product revenue; the market opportunity for Daré’s products and ability to gain market acceptance; potential commercial portfolio expansion; the potential impact of the products that Daré brings to market for women and the Company; development and regulatory pathway plans and expectations regarding Daré’s product candidates, including clinical development strategies, clinical trial design, timelines, costs, milestones, and results, regulatory strategy; timing and outcome of FDA communications, submissions and review of applications; the potential for Daré’s clinical development programs to generate value-driving catalysts and provide a sustained pipeline of differentiated products; the sufficiency of non-dilutive grant and other financial award funding to advance development of specified product candidates or programs, including through specified milestones; expectations regarding existing collaborations and plans for future collaborations; and Daré’s ability to create meaningful long-term value for women and shareholders.

 

Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: Daré’s ability to raise additional capital when and as needed to execute its business strategy and continue as a going concern; potential suspension and delisting of Daré’s common stock from the Nasdaq Capital Market; Daré’s dependence on grants and other financial awards from governmental entities and a private foundation; Daré’s reliance on Section 503B-registered outsourcing facilities and other third parties to bring DARE to PLAY Sildenafil Cream and other solutions to market as compounded drugs or as consumer health products and facilitate access to such products and the risk that those third parties do not perform as expected; difficulties in establishing and sustaining relationships with third-party collaborators; the risk that the U.S. Food and Drug Administration (FDA) could stop permitting Section 503B-registered outsourcing facilities to compound the drug substances in the proprietary formulations Daré intends to bring or brings to market or changes the conditions under which those drug substances may be used in compounding or the compounded products may be distributed; the ability of outsourcing facilities for Daré’s compounded products to maintain their registration with the FDA under Section 503B; the timing of establishing, and ability to maintain, state-required licensure or registration to enable fulfillment of prescriptions for DARE to PLAY Sildenafil Cream and other solutions brought to market via the Section 503B pathway; Daré’s inexperience, as a company, in and limited infrastructure for commercializing products; the degree of market demand and acceptance for the products Daré brings to market; competitive product launches; greater than expected costs to bring compounded drug products to market and marketing costs; shifts in consumer spending or behavior; Daré’s reliance on third parties to manufacture and conduct clinical trials and preclinical studies of its product candidates and commercialize XACIATO™ (clindamycin phosphate) vaginal gel 2% and future FDA-approved products, if any; the risk that the FDA’s 505(b)(2) pathway for drug product approval in the U.S. is not available for a product candidate as Daré anticipates; Daré’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product candidate and the inherent uncertainty of outcomes of clinical trials; Daré’s ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of its product candidates; decisions not to make clinical study design modifications recommended by the FDA; Daré’s dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; the risks that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate and that interim data or results from a particular clinical study do not necessarily predict the final results for that study; the risk that the FDA, other regulatory authorities, members of the scientific or medical communities or investors may not accept or agree with Daré’s interpretation of or conclusions regarding data from clinical studies of its product candidates; the risk that even if a pivotal clinical study achieves its primary efficacy endpoint, the FDA may determine the data package is not sufficient to support a favorable benefit-risk determination in a future marketing application; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré anticipates, or that the duration of a study or number of study subjects must be significantly greater than anticipated; the loss of, or inability to attract, key personnel; product pricing and coverage and reimbursement from third-party payors; Daré’s ability to retain its licensed rights to develop and commercialize a product or product candidate; Daré’s ability to satisfy the monetary obligations and other requirements in connection with its exclusive, in-license agreements covering the critical patents and related intellectual property related to its product and product candidates; Daré’s ability to adequately protect or enforce its, or its licensor’s, intellectual property rights; disputes or other developments concerning Daré’s intellectual property rights; the lack of patent protection for the active ingredients in certain of Daré’s product candidates which could expose its products to competition from other formulations using the same active ingredients; product liability claims; governmental investigations or actions relating to Daré’s products or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; changes in healthcare, pharmaceutical, consumer protection or privacy laws and regulatory policies; increased scrutiny from regulators; global trends toward health care cost containment; the effects of macroeconomic conditions, geopolitical events, and major changes and disruptions in U.S. government policies and operations on Daré’s ability to raise additional capital or on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; and cybersecurity incidents or similar events that compromise Daré’s technology systems and/or significantly disrupt Daré’s business or those of third parties on which it relies.

 

 

 

 

 

 

Daré’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Daré’s risks and uncertainties, you are encouraged to review its documents filed with the U.S. Securities and Exchange Commission (SEC), including Daré’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Daré undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

 

*The terms DARE to PLAY and DARE to RECLAIM describe 503B compounded drug products. Compounded drug products are not approved by the FDA. The FDA does not evaluate compounded drug products for safety, effectiveness, or quality. References to Section 503B, 503B, 503B compounding, 503B compounded product, and similar terms refer to Section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) and the production and supply of compounded drugs by Section 503B-registered outsourcing facilities without patient-specific prescriptions in accordance with Section 503B. Section 503B-registered outsourcing facilities are subject to FDA inspection and required to compound drug products under current Good Manufacturing Practice (cGMP) regulations to ensure quality, strength and consistency.

 

**The term FDA 505(b)(2) regulatory pathway refers to Section 505(b)(2) of the FDCA, which enables an applicant to rely, in part, on the FDA’s prior findings of safety and efficacy data for an existing product, or published literature, in support of the applicant’s new drug application (NDA), providing an alternate path to FDA approval for new or improved formulations or new uses of previously approved drugs.

 

Contact:

 

Daré Bioscience Investor Relations

innovations@darebioscience.com

Source: Daré Bioscience, Inc.

 

 

 

 

 

 

Daré Bioscience, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

 

   Three Months Ended June 30, 
   2026   2025 
Revenue          
Research and development services and royalty revenue  $187,546   $(21,172)
Total revenue   187,546    (21,172)
Cost of revenues   319,889    - 
Operating expenses          
Selling, general and administrative   2,593,671    2,377,866 
Research and development   241,966    1,428,762 
Total operating expenses   2,835,637    3,806,628 
Loss from operations   (2,967,980)   (3,827,800)
Other expense   (14,793)   (188,683)
Net loss  $(2,982,773)  $(4,016,483)
Foreign currency translation adjustments   2,225    12,983 
Comprehensive loss  $(2,980,548)  $(4,003,500)
Loss per common share - basic and diluted  $(0.20)  $(0.45)
Weighted average number of shares outstanding:          
Basic and diluted   14,889,832    8,871,155 

 

Daré Bioscience, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets Data

 

  

June 30, 2026

(unaudited)

   December 31, 2025 
Cash and cash equivalents  $12,617,594   $24,711,356 
Working capital  $(236,457)  $3,378,192 
Total assets  $22,370,109   $32,474,563 
Total stockholders’ (deficit) equity  $(560,100)  $2,842,634 

 

 

 

Filing Exhibits & Attachments

5 documents