Daré Bioscience, Inc. (NASDAQ:DARE) Q4 2023 Earnings Conference Call March 28, 2024 4:30 PM ET Company Participants Sabrina Martucci Johnson - President and CEO MarDee Haring-Layton - Chief Accounting Officer Conference Call Participants Douglas Tsao - H.C. Wainright Will Hidell - Brookline Capital Markets Operator Welcome to the conference call hosted by Daré Bioscience to review the company’s Fourth Quarter Financial Results and to provide a General Business Update. This call is being recorded. My name is ...

Part I [Business](index=5&type=section&id=ITEM%201.%20Business) Daré Bioscience is a biopharmaceutical company focused on women's health, advancing a pipeline of product candidates through clinical development and strategic commercial partnerships - The company's business model is to in-license or acquire promising women's health product candidates, develop them through mid- to late-stage clinical trials, and then partner with larger companies for commercialization[20](index=20&type=chunk) - **XACIATO™**, the company's first FDA-approved product for bacterial vaginosis, was launched in the U.S. in Q4 2023 by commercial partner Organon[21](index=21&type=chunk) - The company's advanced clinical pipeline targets key areas in women's health: Ovaprene® for contraception (pivotal Phase 3), Sildenafil Cream for female sexual arousal disorder (Phase 3 preparation), and DARE-HRT1 for menopause symptoms (Phase 3 preparation)[24](index=24&type=chunk) - Daré actively seeks non-dilutive funding and has received significant grants to support development, including up to approximately **$49.0 million** for the DARE-LARC1 program[28](index=28&type=chunk)[89](index=89&type=chunk) [Our Pipeline: Clinical-Stage Programs](index=9&type=section&id=Our%20Pipeline%3A%20Clinical-Stage%20Programs) The company's diverse clinical-stage pipeline is led by Ovaprene®, Sildenafil Cream, and DARE-HRT1, which are advancing toward or are in late-stage development Advanced Clinical Pipeline Status | Product Candidate | Indication | Development Status | | :--- | :--- | :--- | | **Ovaprene®** | Monthly Contraception (Hormone-free) | Pivotal Phase 3 study commenced Q4 2023 | | **Sildenafil Cream, 3.6%** | Female Sexual Arousal Disorder (FSAD) | End-of-Phase 2 meeting with FDA completed; preparing for Phase 3 | | **DARE-HRT1** | Menopause Symptoms (Hormone Therapy) | Phase 1/2 study completed; preparing for Phase 3 | | **DARE-VVA1** | Painful Intercourse (VVA) | IND cleared; preparing for Phase 2 study | | **DARE-CIN** | HPV / Cervical Dysplasia | Phase 1 and proof-of-concept studies completed | - The pivotal Phase 3 study for Ovaprene® commenced in December 2023, aiming to enroll approximately 250 participants to complete 13 menstrual cycles of use[41](index=41&type=chunk)[42](index=42&type=chunk) - Following the Phase 2b RESPOND study, Daré held a successful end-of-Phase 2 meeting with the FDA in January 2024, aligning on key elements for the Sildenafil Cream Phase 3 program[53](index=53&type=chunk)[54](index=54&type=chunk) [Strategic Agreements and Financing](index=20&type=section&id=Strategic%20Agreements%20and%20Financing) The company has secured key commercialization and financing agreements, including partnerships with Organon and Bayer and a royalty interest financing deal - The exclusive worldwide license agreement with Organon for XACIATO provides for tiered double-digit royalties on net sales and up to **$180.0 million** in potential milestone payments[100](index=100&type=chunk) - The license agreement with Bayer for U.S. commercialization of Ovaprene gives Bayer the option to pay Daré **$20.0 million** to make the license effective, with potential for up to **$310.0 million** in sales-based milestones[103](index=103&type=chunk)[104](index=104&type=chunk) - In December 2023, Daré entered into a royalty interest financing agreement, receiving an initial **$5.0 million** with the option for up to **$7.0 million** more[157](index=157&type=chunk)[158](index=158&type=chunk) [Intellectual Property](index=28&type=section&id=Intellectual%20Property) The company protects its product portfolio through a combination of in-licensed and owned patents, trade secrets, and trademarks across key global jurisdictions - XACIATO is protected by three licensed U.S. patents, with expirations in **December 2028** and **September 2036**[165](index=165&type=chunk) - Ovaprene is covered by nine granted U.S. patents and seven granted foreign patents, with pending applications that could extend protection to **2035**[166](index=166&type=chunk)[167](index=167&type=chunk) - Sildenafil Cream is protected by 10 U.S. patents and 13 foreign patents, with U.S. patents having terms expiring in **June 2029**[168](index=168&type=chunk) [Government Regulation](index=31&type=section&id=Government%20Regulation) The company's operations are subject to extensive regulation by the FDA and other authorities, utilizing pathways like 505(b)(2) to streamline development - The company's products are subject to rigorous premarket review and post-marketing oversight by the FDA and other government bodies[186](index=186&type=chunk)[188](index=188&type=chunk) - Daré plans to utilize the FDA's **505(b)(2) pathway** for many of its product candidates, which allows reliance on prior findings of safety and efficacy for an approved product[204](index=204&type=chunk) - Combination products like Ovaprene (drug-device) are subject to complex regulatory processes with the FDA's Office of Combination Products[238](index=238&type=chunk)[240](index=240&type=chunk) [Risk Factors](index=55&type=section&id=ITEM%201A.%20Risk%20Factors) The company faces significant financial risks regarding its going concern status, alongside clinical development, third-party reliance, and commercialization uncertainties - The company requires substantial additional capital to continue operations and has a history of losses, raising **substantial doubt about its ability to continue as a going concern**[324](index=324&type=chunk) - Clinical development is inherently uncertain, and failure to successfully complete trials and obtain regulatory approval for key product candidates like Ovaprene and Sildenafil Cream would materially harm the business[320](index=320&type=chunk)[352](index=352&type=chunk) - The company is **heavily reliant on third parties**, including Organon for XACIATO commercialization revenue and single-source contract manufacturers for product supply[320](index=320&type=chunk)[405](index=405&type=chunk) - On July 19, 2023, the company was notified by Nasdaq of non-compliance with the **minimum $1.00 bid price requirement**, with an exception until July 15, 2024, to regain compliance[578](index=578&type=chunk)[579](index=579&type=chunk) [Unresolved Staff Comments](index=107&type=section&id=ITEM%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the SEC - None[602](index=602&type=chunk) [Cybersecurity](index=107&type=section&id=ITEM%201C.%20Cybersecurity) Cybersecurity risk is managed through an enterprise program overseen by the audit committee, and no material threats have been identified to date - Cybersecurity risk is managed through an enterprise risk management program overseen by the audit committee, which receives periodic updates from management and an external IT consultant[603](index=603&type=chunk)[608](index=608&type=chunk) - The company utilizes multiple security layers, conducts annual cybersecurity assessments, and maintains an incident response plan to safeguard information assets and operational integrity[604](index=604&type=chunk)[605](index=605&type=chunk) - The company does not believe there are any risks from cybersecurity threats that have materially affected or are reasonably likely to materially affect its business, operations, or financial condition[606](index=606&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=109&type=section&id=ITEM%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on the Nasdaq Capital Market under "DARE," and it has never paid cash dividends, retaining earnings for growth - The company's common stock is listed on the Nasdaq Capital Market under the trading symbol **'DARE'**[614](index=614&type=chunk) - The company has **never declared or paid cash dividends** and does not plan to in the foreseeable future[616](index=616&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=109&type=section&id=ITEM%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company reported a net loss of $30.2 million in 2023 with decreased revenue and R&D expenses, and requires additional capital to fund operations Consolidated Results of Operations (2023 vs. 2022) | | 2023 | 2022 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | **Total Revenue** | $2,807,885 | $10,000,000 | $(7,192,115) | (72)% | | **R&D Expenses** | $21,538,074 | $30,042,217 | $(8,504,143) | (28)% | | **G&A Expenses** | $12,109,691 | $11,243,271 | $866,420 | 8% | | **Loss from Operations** | $(30,939,880) | $(31,385,488) | $445,608 | 1% | | **Net Loss** | $(30,161,391) | $(30,947,738) | $786,347 | (3)% | - The company will need to raise additional capital to fund its operating needs into the third quarter of 2024, which raises **substantial doubt about its ability to continue as a going concern**[674](index=674&type=chunk)[678](index=678&type=chunk) - Revenue in 2023 of **$2.8 million** was primarily from a $1.8 million milestone payment and a $1.0 million license fee amendment from Organon, down from **$10.0 million** in 2022[664](index=664&type=chunk) - R&D expenses decreased by **$8.5 million** in 2023, mainly due to a **$6.4 million** reduction in development costs for Sildenafil Cream[666](index=666&type=chunk) [Controls and Procedures](index=120&type=section&id=ITEM%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls, procedures, and internal control over financial reporting were effective as of year-end 2023 - Management concluded that the company's disclosure controls and procedures were **effective** as of December 31, 2023[695](index=695&type=chunk) - Management concluded that the company's internal control over financial reporting was **effective** as of December 31, 2023, based on the COSO 2013 framework[699](index=699&type=chunk) - **No changes** in internal control over financial reporting occurred during the fourth quarter of 2023 that have materially affected, or are reasonably likely to materially affect, these controls[701](index=701&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=122&type=section&id=ITEM%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Required information regarding directors, officers, and corporate governance is incorporated by reference from the company's 2024 proxy statement - Information for this item is incorporated by reference from the company's 2024 Proxy Statement[706](index=706&type=chunk) [Executive Compensation](index=122&type=section&id=ITEM%2011.%20Executive%20Compensation) Required information concerning executive compensation is incorporated by reference from the company's 2024 proxy statement - Information for this item is incorporated by reference from the company's 2024 Proxy Statement[707](index=707&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=122&type=section&id=ITEM%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Required information concerning security ownership is incorporated by reference from the company's 2024 proxy statement - Information for this item is incorporated by reference from the company's 2024 Proxy Statement[708](index=708&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=122&type=section&id=ITEM%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Required information concerning related party transactions and director independence is incorporated by reference from the company's 2024 proxy statement - Information for this item is incorporated by reference from the company's 2024 Proxy Statement[709](index=709&type=chunk) [Principal Accountant Fees and Services](index=122&type=section&id=ITEM%2014.%20Principal%20Accountant%20Fees%20and%20Services) Required information concerning principal accountant fees and services is incorporated by reference from the company's 2024 proxy statement - Information for this item is incorporated by reference from the company's 2024 Proxy Statement[710](index=710&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=123&type=section&id=ITEM%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the financial statements, schedules, and exhibits filed with the Form 10-K, including key commercial and financing agreements - This section contains the index to the Consolidated Financial Statements, which begin on page F-1[713](index=713&type=chunk) - A list of exhibits is provided, including key commercial agreements with Organon and Bayer, and the recent Royalty Interest Financing Agreement[715](index=715&type=chunk)[717](index=717&type=chunk) Financial Statements [Report of Independent Registered Public Accounting Firm](index=131&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) The auditor's report provides a clean opinion on the financial statements but includes a paragraph highlighting substantial doubt about the company's going concern status - The auditor's report contains a **"going concern" paragraph**, citing recurring losses, negative cash flow, and dependence on additional financing, which raise substantial doubt about the company's ability to continue operations[730](index=730&type=chunk) - The auditor's opinion states that the financial statements for the year ended December 31, 2023, are **fairly presented** in conformity with U.S. GAAP[729](index=729&type=chunk) [Consolidated Financial Statements](index=134&type=section&id=Consolidated%20Financial%20Statements) The company's financial position weakened in 2023, with cash decreasing to $10.5 million, total assets declining, and a shift to a stockholders' deficit of $5.0 million Key Balance Sheet Data (as of Dec 31) | | 2023 | 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $10,476,056 | $34,669,605 | | Total Assets | $21,282,215 | $43,826,383 | | Total Liabilities | $26,329,855 | $32,714,273 | | Total stockholders' equity (deficit) | $(5,047,640) | $11,112,110 | Key Cash Flow Data (Year Ended Dec 31) | | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(38,856,654) | $(18,088,429) | | Net cash provided by financing activities | $15,637,120 | $1,343,354 | | Net decrease in cash | $(23,858,549) | $(17,004,482) | [Notes to Consolidated Financial Statements](index=138&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes detail the going concern uncertainty, terms of strategic agreements, equity financing activities, and significant non-dilutive grant funding - Note 2 (Going Concern): The financial statements were prepared on a going concern basis, but management notes that the company's history of losses and need for additional capital raise **substantial doubt** about this assumption[765](index=765&type=chunk)[768](index=768&type=chunk) - Note 11 (Sale of Future Royalties): In December 2023, the company received **$5.0 million** from the sale of an interest in future XACIATO royalties, which was recorded as a liability[890](index=890&type=chunk)[892](index=892&type=chunk)[898](index=898&type=chunk) - Note 13 (Grant Awards): The company has received significant non-dilutive funding from the Bill & Melinda Gates Foundation for its DARE-LARC1 program, with a cumulative total of **$28.4 million** received as of December 31, 2023[916](index=916&type=chunk)[917](index=917&type=chunk)[918](index=918&type=chunk) - Note 8 (Stockholders' Equity): In 2023, the company raised approximately **$7.0 million (net)** from a registered direct offering of stock and warrants in September, and approximately **$2.3 million (net)** from its ATM sales agreement[860](index=860&type=chunk)[861](index=861&type=chunk)

Financial Performance - Daré Bioscience reported total revenue of approximately $2.8 million for the year ended December 31, 2023, including a $1.0 million payment in July and a $1.8 million milestone payment in October from collaborator Organon related to XACIATO[21] - Total revenue for 2023 was $2,807,885, a decrease of 72.1% compared to $10,000,000 in 2022[38] - The company recognized a net loss of approximately $30.1 million for 2023, with general and administrative expenses of approximately $12.1 million, up about 8% compared to the prior year[21] - Net loss for 2023 was $30,161,391, compared to a net loss of $30,947,738 in 2022, representing a 2.5% improvement[38] - Comprehensive loss for 2023 was $30,170,976, compared to $31,144,076 in 2022, showing a 3.1% improvement[38] - Loss per common share for 2023 was $0.35, slightly improved from $0.37 in 2022[38] - Cash and cash equivalents decreased to $10,476,056 in 2023 from $34,669,605 in 2022, a decline of 69.7%[38] - Total assets decreased to $21,282,215 in 2023 from $43,826,383 in 2022, a reduction of 51.4%[38] - Total liabilities decreased to $26,329,855 in 2023 from $32,714,273 in 2022, a decrease of 19.5%[38] - Operating expenses for 2023 were $33,747,765, down 18.5% from $41,385,488 in 2022[38] Research and Development - Research and development expenses were approximately $21.5 million in 2023, down from approximately $30.0 million in the prior year, primarily due to costs associated with clinical studies[21] - Daré commenced the Phase 3 clinical study for its hormone-free monthly intravaginal contraceptive candidate Ovaprene in December 2023, with recruitment currently underway at 17 sites across the U.S.[10] - The FDA has cleared the investigational new drug application for DARE-VVA1, a non-hormonal treatment for sexual pain, allowing Daré to plan for a Phase 2 clinical study[18] - Positive topline results were announced for DARE-PDM1, an investigational formulation of diclofenac for treating menstrual cramping pain, following a Phase 1 study[16] - Daré anticipates providing updates on the FDA feedback and Phase 3 study design for Sildenafil Cream in 2Q-2024[14] Collaborations and Milestones - The first shipment of XACIATO™ triggered a $1.8 million milestone payment from Organon, and the product is now available nationwide by prescription[7] - Daré is eligible to receive double-digit royalties based on net sales of XACIATO and up to $180 million in potential milestone payments from Organon[8] Future Outlook - The company expects a reduction in 2024 general and administrative expenses to approximately $10.0 million, despite projected accrual-based non-cash expenses[21] - The weighted average number of common shares outstanding increased to 87,303,701 in 2023 from 84,571,805 in 2022[38] Recognition - The company has been recognized for its contributions to women's health and innovation, with leadership accolades in 2022 and 2023[33]

SAN DIEGO, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, and its collaborator Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced the successful completion of an end-of-Phase 2 (EoP2) meeting with the U.S. Food and Drug Administration (FDA), supporting advancement of Sildenafil Cream, 3.6% (Sildenafil Cream) for the treatment of female sexual arousal disorder (FSAD) to a Phase ...

SAN DIEGO, Jan. 26, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced changes in company management which includes the retirement of Chief Financial Officer, Lisa Walters-Hoffert, and the resignation of Chief Commercial Officer, John Fair. Both Ms. Walters-Hoffert and Mr. Fair have entered into plans with the Company to help ensure a seamless transition. Daré also announced an adjustment to the size of its Board of Directors to better refl ...

Financial Data and Key Metrics Changes - The comprehensive loss for the third quarter was approximately $8.3 million, with cash and cash equivalents at approximately $13.9 million as of the end of the quarter [37] - General and administrative expenses were approximately $2.7 million, unchanged from the same period in 2022, while R&D expenses were approximately $6.7 million, primarily related to the Sildenafil Cream Phase 2b clinical trial and Ovaprene's planned Phase 3 study [24] Business Line Data and Key Metrics Changes - The company is advancing its key pipeline programs, including Sildenafil Cream and Ovaprene, which represent potential first-in-category opportunities in women's health [17] - The company recognized license fee revenue of $1 million under its global license agreement with Organon during the third quarter [37] Market Data and Key Metrics Changes - Market research indicates that approximately 20 million women in the U.S. aged 21 to 60 experience symptoms of low or no sexual arousal, with about 10 million actively seeking treatment, highlighting a significant untapped market [83] - There are currently no FDA-approved monthly hormone-free contraceptives, with approximately 35 million women in the U.S. identified as potential candidates for Ovaprene [8] Company Strategy and Development Direction - The company aims to address unmet needs in women's health by developing innovative treatments and collaborating with leading players like Organon and Bayer [17][67] - The strategic focus includes maintaining fiscal responsibility while exploring creative funding opportunities to support its portfolio [25][40] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the progress made on late-stage programs and emphasized the company's unique position in developing women's health products [20][81] - The company is on track to initiate the Phase 3 trial for Ovaprene and is collaborating with NICHD to ensure a seamless transition from clinical development to commercialization [22][84] Other Important Information - The pivotal Phase 3 study of Ovaprene is supported by NICHD's contraceptive development program, which oversees the contraceptive Clinical Trials Network [33] - The company plans to issue updates on patient enrollment for Ovaprene and intends to keep stakeholders informed as the study progresses [43][74] Q&A Session Summary Question: Will there be periodic updates regarding Ovaprene enrollment? - Management intends to keep stakeholders informed about enrollment progress and will announce when the first patient is enrolled [43] Question: What is the estimated cost of the Ovaprene study and its funding status? - The study is funded with $5 million already provided to cover its costs, with additional support from NICHD [45] Question: Are there plans for partnerships regarding Sildenafil Cream? - The company is considering all possibilities for funding and partnerships, especially given the interest in Sildenafil Cream as a first-in-category product [59] Question: What endpoints will be focused on in the Ovaprene study? - The primary endpoint is preventing pregnancy, but additional data on user experience and safety will also be collected [63][64]

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, 2023 OR ☐ 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 DARÉ BIOSCIENCE, INC. (Exact Name of Registrant as Specified in its Charter) Delaware (State or Other Jurisdiction of I ...

DARÉ IN ITALIAN, IT MEANS "TO GIVE." IN ENGLISH, IT MEANS "TO BE BOLD." Women At Daré Bioscience, women's health is Our Sole Focus. Innovation in women's health needs to be a priority. We are working hard to identify and advance new therapies that provide additional choices and improve outcomes so that we can make a difference in the lives of women everywhere. Daré Programs Update, 08.10.2023 www.darebioscience.com 1 This presentation is for informational purposes only and is not an offer to sell or a solic ...

Daré Bioscience, Inc. (NASDAQ:DARE) Q2 2023 Earnings Conference Call August 10, 2023 4:30 PM ET Company Participants Sabrina Martucci Johnson - President and Chief Executive Officer John Fair - Chief Commercial Officer Lisa Walters-Hoffert - Chief Financial Officer Conference Call Participants Catherine Novack - Jones Research Operator Welcome to the conference hosted by Daré Bioscience to review the Company’s Financial Results for the Quarter Ended June 30, 2023, and to provide a General Business Update. T ...

Financial Performance - Total revenue for Q2 2023 was $0, compared to $10 million in Q2 2022, indicating a 100% decrease year-over-year[16] - Operating expenses for Q2 2023 were $8.99 million, a slight decrease of 6.5% from $9.62 million in Q2 2022[16] - Net loss for Q2 2023 was $8.76 million, compared to a net income of $414,000 in Q2 2022, reflecting a significant decline in financial performance[16] - The company reported a comprehensive loss of $8.79 million for Q2 2023, compared to a comprehensive income of $278,000 in Q2 2022[16] - Basic loss per share for Q2 2023 was $0.10, compared to no loss per share reported in Q2 2022[16] - For the six months ended June 30, 2023, the company reported a net loss of approximately $16.8 million, compared to a net loss of $7.98 million for the same period in 2022, representing a 110% increase in losses year-over-year[23] Cash and Assets - Cash and cash equivalents decreased to $13.33 million as of June 30, 2023, down from $34.67 million at the end of 2022, representing a 61.5% decline[15] - Total assets decreased to $23.21 million as of June 30, 2023, from $43.83 million at the end of 2022, indicating a 47% reduction[15] - The company's cash and cash equivalents decreased to approximately $13.3 million as of June 30, 2023, down from $32.1 million at the end of June 2022, indicating a decline of about 59%[23] - As of June 30, 2023, the Company reported cash equivalents of $10,837,944, a decrease from $33,238,658 as of December 31, 2022[41] Liabilities and Deficits - Current liabilities increased to $24.70 million as of June 30, 2023, compared to $31.62 million at the end of 2022, showing a 21.9% decrease[15] - The accumulated deficit grew to $157.88 million as of June 30, 2023, up from $141.07 million at the end of 2022, reflecting a worsening financial position[15] - The total accumulated deficit reached approximately $157.9 million as of June 30, 2023, compared to $118.1 million at the same time in 2022, reflecting an increase of approximately 34%[34] - The company has a working capital deficit of approximately $2.5 million as of June 30, 2023, indicating liquidity challenges[34] Research and Development - Research and development expenses for the first half of 2023 were $11.06 million, down from $12.60 million in the same period of 2022, a decrease of 12.2%[16] - The company plans to continue its focus on research and development activities to advance its product candidates through clinical development and regulatory approval[27] Capital and Funding - The company expects to require substantial additional capital to fund its operations and execute its current strategy over the next 12 months[35] - The company raised $1.3 million from the exercise of common stock warrants during the six months ended June 30, 2023, compared to $120,149 in the same period of 2022, showing a significant increase in capital raised[23] Licensing and Revenue - The Company has recognized $10.0 million in license fee revenue from its license agreement for XACIATO, all of which represents the upfront payment due[45] - The Company is entitled to receive up to $310.0 million in milestone payments related to the commercial sales of Ovaprene, contingent upon achieving specified milestones[50] - The license agreement with Organon includes tiered double-digit royalties based on net sales and up to $182.5 million in milestone payments[53] - The Company has not recognized any collaboration revenues as of June 30, 2023[44] - The Company has not recognized any royalty revenue as of June 30, 2023[46] Stock and Compensation - Total stock-based compensation expense for the six months ended June 30, 2023, was $1,274,807, compared to $1,069,930 for the same period in 2022, reflecting an increase of approximately 19.1%[100] - The number of shares of common stock available for future awards under the 2022 Stock Incentive Plan was 6,718,916 as of June 30, 2023[98] - The number of shares outstanding under the stock option plans increased from 6,612,554 at December 31, 2022, to 9,470,219 at June 30, 2023, reflecting an increase of approximately 43.5%[99] Agreements and Milestones - The Company agreed to pay former MBI stockholders up to $46.5 million contingent upon achieving specified funding, product development, and regulatory milestones[65] - The Company may pay MilanaPharm up to $500,000 upon the first commercial sale of licensed products in the U.S., and $1.0 million upon achieving $50 million in cumulative worldwide net sales[68] - The Company acquired Pear Tree Pharmaceuticals for exclusive rights to develop a proprietary formulation of tamoxifen, leading to the DARE-VVA1 program[70] - The Company agreed to pay former stockholders of Pear Tree up to $15.5 million for clinical milestones and up to $47 million for commercial milestones[72] Grants and Funding - The Company received a total of approximately $23.9 million in non-dilutive funding under the DARE-LARC1 grant agreement as of June 30, 2023, with a deferred grant funding liability of approximately $13.1 million recorded[123] - The Company received a grant of approximately $385,000 from NICHD on July 28, 2023, to support preclinical development for a new therapeutic[127]