Daré Bioscience, Inc. (NASDAQ:DARE) Q4 2021 Earnings Conference Call March 31, 2022 4:30 PM ET Company Participants Sabrina Martucci Johnson – President and Chief Executive Officer Lisa Walters-Hoffert – Chief Financial Officer John Fair – Chief Strategy Officer Conference Call Participants Zegbah Jallah – ROTH Capital Partners, LLC Douglas Tsao – H.C. Wainwright & Co. Kumaraguru Raja – Brookline Capital Markets Operator Welcome to the conference call hosted by Daré Bioscience to review the company's financ ...

UNITED STATES ☒ For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _____ TO_____ | --- | --- | |-------|-----------------------------------------------------------------------------------------------------------------| | | SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________________ | | | FORM 10-K _____________________________________________ ...

Daré Bioscience, Inc. (NASDAQ:DARE) Q3 2021 Earnings Conference Call November 10, 2021 4:30 PM ET Company Participants Sabrina Martucci Johnson - President and CEO John Fair - Chief Strategy Officer Lisa Walters-Hoffert - CFO Conference Call Participants Zegbeh Jallah - ROTH Capital Partners Chris Bialas – H.C. Wainwright Operator Welcome to the conference call hosted by Daré Bioscience to review the Company’s Financial Results for the Quarter Ended September 30, 2021, and to provide a General Business Upda ...

[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) The financial information section provides an overview of the company's unaudited financial statements, management's discussion, market risk disclosures, and internal controls [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) The unaudited financial statements for the period ended September 30, 2021, show a significant increase in cash and total assets, driven by financing activities, shifting the company to positive equity despite rising operating expenses and a wider net loss, highlighting a 'going concern' uncertainty [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's financial position, detailing assets, liabilities, and equity as of September 30, 2021, compared to December 31, 2020 Balance Sheet Summary (Unaudited) | Metric | Sep 30, 2021 (USD) | Dec 31, 2020 (USD) | | :--- | :--- | :--- | | **Cash and cash equivalents** | **$45,570,781** | **$4,669,467** | | Total current assets | $48,243,154 | $6,983,912 | | **Total assets** | **$48,811,476** | **$7,550,712** | | Total current liabilities | $15,907,086 | $7,660,601 | | **Total liabilities** | **$16,922,885** | **$8,702,445** | | **Total stockholders' equity (deficit)** | **$31,888,591** | **($1,151,733)** | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section outlines the company's revenues and expenses over specific periods, leading to the reported net loss Statement of Operations Summary (Unaudited) | Metric | Three Months Ended Sep 30, 2021 (USD) | Three Months Ended Sep 30, 2020 (USD) | Nine Months Ended Sep 30, 2021 (USD) | Nine Months Ended Sep 30, 2020 (USD) | | :--- | :--- | :--- | :--- | :--- | | General and administrative | $2,211,334 | $1,353,069 | $5,949,299 | $4,772,382 | | Research and development | $10,432,603 | $6,203,753 | $23,501,098 | $14,131,007 | | **Total operating expenses** | **$12,668,937** | **$7,581,822** | **$29,525,397** | **$18,961,722** | | **Net loss** | **($12,667,429)** | **($7,582,808)** | **($29,153,824)** | **($18,959,268)** | | Loss per common share | ($0.18) | ($0.24) | ($0.45) | ($0.69) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section details the cash inflows and outflows from operating, investing, and financing activities for the specified periods Cash Flow Summary for Nine Months Ended Sep 30 (Unaudited) | Metric | 2021 (USD) | 2020 (USD) | | :--- | :--- | :--- | | Net cash used in operating activities | ($18,848,138) | ($16,041,176) | | Net cash used in investing activities | ($14,524) | ($15,246) | | **Net cash provided by financing activities** | **$59,842,978** | **$16,675,911** | | Net change in cash and cash equivalents | $40,901,314 | $609,307 | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's business focus on women's health, its product pipeline, and significant accounting policies, highlighting a 'Going Concern' uncertainty and providing extensive details on license agreements, equity financing, and grant funding - The company is a clinical-stage biopharmaceutical firm focused on women's health, with three product candidates in advanced clinical development: **DARE-BV1**, **Ovaprene®**, and **Sildenafil Cream, 3.6%**[29](index=29&type=chunk)[31](index=31&type=chunk) - There is substantial doubt about the company's ability to continue as a going concern due to a history of operating losses and the need to raise substantial additional capital to fund its operating plan for the next 12 months[37](index=37&type=chunk)[43](index=43&type=chunk) - The company received a **$1.0 million** upfront payment from Bayer for the Ovaprene license agreement, with the license becoming effective if Bayer pays an additional **$20.0 million**, which could also trigger up to **$310.0 million** in commercial milestone payments[63](index=63&type=chunk)[64](index=64&type=chunk) - In June 2021, the company was awarded up to **$48.95 million** from the Bill & Melinda Gates Foundation to support the development of DARE-LARC1, receiving an initial payment of **$11.45 million** in July 2021[123](index=123&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on advancing its women's health portfolio, highlighting the submission of the DARE-BV1 NDA to the FDA, which was granted Priority Review, detailing a significant year-over-year increase in operating expenses, primarily R&D costs, and reiterating the 'going concern' risk due to insufficient cash, with capital primarily raised through ATM equity offerings [Business Overview and Clinical Stage Product Candidates](index=30&type=section&id=Business%20Overview%20and%20Clinical%20Stage%20Product%20Candidates) This section provides an overview of the company's strategic focus and the progress of its key clinical-stage product candidates - The company submitted a New Drug Application (NDA) for **DARE-BV1** to the FDA in June 2021, which was accepted, granted Priority Review, and set a PDUFA target action date of December 7, 2021[140](index=140&type=chunk) - A pivotal Phase 3 clinical study of **Ovaprene** is planned to commence in 2022, supported by a Cooperative Research and Development Agreement (CRADA) with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)[144](index=144&type=chunk) - The Phase 2b RESPOND clinical trial of **Sildenafil Cream, 3.6%** is ongoing, but the pace of enrollment has been slower than initially expected, potentially increasing the study's timeline and overall cost[146](index=146&type=chunk) [Results of Operations](index=38&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, focusing on the changes in operating expenses over the reported periods Comparison of Operating Expenses (Unaudited) | Expense Category | Three Months Ended Sep 30, 2021 (USD) | Three Months Ended Sep 30, 2020 (USD) | Nine Months Ended Sep 30, 2021 (USD) | Nine Months Ended Sep 30, 2020 (USD) | | :--- | :--- | :--- | :--- | :--- | | General & administrative | $2,211,334 | $1,353,069 | $5,949,299 | $4,772,382 | | Research & development | $10,432,603 | $6,203,753 | $23,501,098 | $14,131,007 | - The increase in R&D expenses for the three and nine months ended Sep 30, 2021 was primarily driven by costs for the **Sildenafil Cream 3.6% Phase 2b trial** and activities for **Ovaprene**, partially offset by decreased costs for **DARE-BV1** following the completion of its Phase 3 trial in late 2020[173](index=173&type=chunk)[180](index=180&type=chunk) - The increase in G&A expenses was mainly due to higher professional services, commercial-readiness activities, personnel costs, and stock-based compensation[170](index=170&type=chunk)[179](index=179&type=chunk) [Liquidity and Capital Resources](index=41&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet its short-term and long-term financial obligations and its strategies for funding operations - Management states that based on the current operating plan, the company does not have sufficient cash to satisfy its working capital needs for at least the next 12 months[189](index=189&type=chunk) - The company needs to raise substantial additional capital to continue funding operations and executing its development plan, primarily relying on sales of common stock through ATM offerings[190](index=190&type=chunk) - During the nine months ended September 30, 2021, the company received approximately **$59.8 million** in net cash from financing activities, predominantly from sales of common stock[189](index=189&type=chunk)[192](index=192&type=chunk)[196](index=196&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=44&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Daré Bioscience is not required to provide the information for this item - The company is a smaller reporting company and is not required to provide disclosures about market risk[202](index=202&type=chunk) [Item 4. Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective at a reasonable assurance level as of September 30, 2021, with no material changes in internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of September 30, 2021[204](index=204&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, these controls[205](index=205&type=chunk) [PART II. OTHER INFORMATION](index=45&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers other important information including legal proceedings, updated risk factors, unregistered equity sales, and a list of exhibits [Item 1. Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that as of the filing date, there are no material pending legal proceedings to which it is a party - There are no material pending legal proceedings involving the company[207](index=207&type=chunk) [Item 1A. Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) This section updates and emphasizes key business risks, including potential FDA non-approval for DARE-BV1, lack of a finalized commercialization strategy, heavy reliance on NICHD for the Ovaprene trial, and ongoing impacts of the COVID-19 pandemic - A primary risk is that the FDA could issue a Complete Response Letter (CRL) for the **DARE-BV1 NDA**, indicating non-approval in its current form, which could significantly delay marketing, increase costs, and negatively affect the company's stock price and ability to raise capital[209](index=209&type=chunk)[210](index=210&type=chunk) - The company has not finalized its commercial strategy for **DARE-BV1** and lacks internal capabilities for marketing and sales, creating risk around a timely and successful product launch if approved[213](index=213&type=chunk)[214](index=214&type=chunk) - The **COVID-19 pandemic** continues to pose a risk by potentially delaying clinical trials, disrupting supply chains for clinical materials, and negatively impacting the company's ability to access capital[218](index=218&type=chunk)[222](index=222&type=chunk) - The company is highly dependent on **NICHD** for the pivotal Phase 3 trial of **Ovaprene** under the CRADA, where termination of this agreement or failure by NICHD to perform could significantly delay the program[216](index=216&type=chunk)[235](index=235&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=51&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) On September 1, 2021, the company issued approximately 700,000 shares of its common stock to former stockholders of Microchips Biotech, Inc. (MBI) as partial payment for milestone achievements related to the 2019 merger agreement, issued in a private placement exempt from registration - In September 2021, the company issued **~700,000 shares** of common stock to former MBI stockholders to satisfy milestone payments from the 2019 acquisition[251](index=251&type=chunk) [Item 6. Exhibits](index=52&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, which include an amendment to a license agreement, the Cooperative Research and Development Agreement (CRADA) with NICHD, officer certifications required by the Sarbanes-Oxley Act, and XBRL data files - Key exhibits filed include the **CRADA with NICHD** for the Ovaprene Phase 3 study and an amendment to the license agreement with TriLogic Pharma and MilanaPharm[257](index=257&type=chunk)

Daré Bioscience, Inc. (NASDAQ:DARE) Q2 2021 Earnings Conference Call August 12, 2021 4:30 PM ET Company Participants Sabrina Martucci Johnson - President and CEO John Fair - CSO Lisa Walters-Hoffert - CFO Conference Call Participants Zegbeh Jallah - ROTH Capital Partners Doug Tsao - H. C. Wainwright Kumar Raja - Brookline Capital Markets Operator Thank you all for standing-by. And welcome to the conference call hosted by Daré Bioscience to review the Company’s Financial Results for the Quarter Ended June 30 ...

[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) The company reports a wider net loss and higher operating expenses driven by increased R&D costs [Financial Statements](index=6&type=section&id=Financial%20Statements) Financials show a widened net loss and increased cash from financing activities in H1 2021 Condensed Consolidated Balance Sheets | Financial Metric | June 30, 2021 (Unaudited) | December 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $9,111,741 | $4,669,467 | | Total current assets | $14,059,220 | $6,983,912 | | Total assets | $14,822,410 | $7,550,712 | | Total liabilities | $7,078,406 | $8,702,445 | | Total stockholders' equity (deficit) | $7,744,004 | $(1,151,733) | Condensed Consolidated Statements of Operations (Three Months) | Metric | Three Months Ended June 30, 2021 | Three Months Ended June 30, 2020 | | :--- | :--- | :--- | | Research and development | $7,340,289 | $5,547,450 | | Total operating expenses | $9,162,926 | $7,125,831 | | Net loss | $(9,162,751) | $(7,124,213) | | Loss per common share | $(0.18) | $(0.27) | Condensed Consolidated Statements of Operations (Six Months) | Metric | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Research and development | $13,068,495 | $7,927,254 | | Total operating expenses | $16,856,460 | $11,379,900 | | Net loss | $(16,486,395) | $(11,376,461) | | Loss per common share | $(0.35) | $(0.45) | Condensed Consolidated Statements of Cash Flows | Cash Flow Activity (Six Months Ended June 30) | 2021 | 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(20,168,469) | $(10,684,464) | | Net cash provided by financing activities | $24,626,464 | $11,277,329 | | Net change in cash and cash equivalents | $4,442,274 | $566,765 | [Notes to Financial Statements](index=11&type=section&id=Notes%20to%20Financial%20Statements) Notes highlight a 'going concern' warning, significant financing, and key post-quarter FDA updates - The company's financial statements were prepared on a going concern basis, but recurring losses and negative cash flows raise **"substantial doubt about the Company's ability to continue as a going concern"**[37](index=37&type=chunk)[43](index=43&type=chunk) - In June 2021, the company entered into a new grant agreement with the Bill & Melinda Gates Foundation for up to **$48.95 million** to support the development of DARE-LARC1[118](index=118&type=chunk)[126](index=126&type=chunk) - Subsequent to the quarter end, the **FDA accepted the New Drug Application (NDA) for DARE-BV1**, granted Priority Review, and set a PDUFA target action date of December 7, 2021[128](index=128&type=chunk)[129](index=129&type=chunk) - In July 2021, the company entered into a Cooperative Research and Development Agreement (CRADA) with NICHD for the pivotal Phase 3 study of Ovaprene, committing to **$5.5 million** in payments[122](index=122&type=chunk) - Between July 1 and August 9, 2021, the company sold approximately **13.1 million shares** of common stock under its ATM equity offering program for net proceeds of approximately **$25.4 million**[125](index=125&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses rising R&D expenses, a critical liquidity position, and key clinical pipeline updates [Business Overview and Clinical Pipeline](index=30&type=section&id=Business%20Overview%20and%20Clinical%20Pipeline) The company focuses on advancing its women's health portfolio, led by DARE-BV1, Ovaprene, and Sildenafil Cream - The company's portfolio has **three product candidates in advanced clinical development**: DARE-BV1, Ovaprene®, and Sildenafil Cream, 3.6%[133](index=133&type=chunk) - The FDA accepted the NDA for DARE-BV1, granted **Priority Review**, and set a PDUFA target action date of **December 7, 2021**[142](index=142&type=chunk) - A pivotal **Phase 3 study of Ovaprene** is planned to commence in 2022 under a Cooperative Research and Development Agreement (CRADA) with the NICHD[144](index=144&type=chunk) - The **Phase 2b RESPOND clinical trial** of Sildenafil Cream, 3.6% is ongoing, but enrollment has declined at some sites due to COVID-19 related guidelines[145](index=145&type=chunk) [Results of Operations](index=39&type=section&id=Results%20of%20Operations) Operating expenses increased significantly due to higher R&D costs for key clinical trials Comparison of Operating Expenses (Three Months) | Expense Category | Three Months Ended June 30, 2021 | Three Months Ended June 30, 2020 | | :--- | :--- | :--- | | General and administrative | $1,797,637 | $1,557,548 | | Research and development | $7,340,289 | $5,547,450 | | **Total operating expenses** | **$9,162,926** | **$7,125,831** | Comparison of Operating Expenses (Six Months) | Expense Category | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | General and administrative | $3,737,965 | $3,419,313 | | Research and development | $13,068,495 | $7,927,254 | | **Total operating expenses** | **$16,856,460** | **$11,379,900** | - The increase in R&D expenses for H1 2021 was primarily driven by a **$3.7 million increase** in costs for lead clinical-stage candidates and a **$1.9 million increase** for Phase 1 programs[179](index=179&type=chunk) - In Q1 2021, the company recorded a gain of **$369,887** from the full forgiveness of its Paycheck Protection Program (PPP) loan[182](index=182&type=chunk)[111](index=111&type=chunk) [Liquidity and Capital Resources](index=42&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces a 'going concern' issue and requires substantial additional capital despite recent fundraising - The company explicitly states there is **"substantial doubt about our ability to continue as a going concern"** and that cash on hand is not sufficient for the next 12 months[183](index=183&type=chunk)[188](index=188&type=chunk) - During the first six months of 2021, the company raised approximately **$24.6 million** through financing activities, primarily from the sale of common stock[196](index=196&type=chunk)[188](index=188&type=chunk) - Post-quarter financing activities provided significant additional capital, including **$25.4 million** from ATM sales and an **$11.45 million** initial grant payment[188](index=188&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=45&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exempt from market risk disclosures as a smaller reporting company - The company is exempt from this disclosure requirement as it qualifies as a **smaller reporting company** under SEC rules[202](index=202&type=chunk) [Item 4. Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of the quarter-end - Based on an evaluation, the CEO and CFO concluded that the company's **disclosure controls and procedures were effective** as of June 30, 2021[204](index=204&type=chunk) - **No material changes** in internal control over financial reporting occurred during the quarter[205](index=205&type=chunk) [PART II. OTHER INFORMATION](index=46&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=46&type=section&id=Item%201.%20Legal%20Proceedings) The company is not a party to any material pending legal proceedings - There are **no material pending legal proceedings** to which the company is a party[207](index=207&type=chunk) [Item 1A. Risk Factors](index=46&type=section&id=Item%201A.%20Risk%20Factors) Key risks include potential FDA rejection of DARE-BV1, commercialization challenges, and clinical trial delays - A significant risk is that the FDA could issue a **complete response letter (CRL) for the DARE-BV1 NDA**, which would prevent approval and could cause the stock price to drop significantly[209](index=209&type=chunk)[210](index=210&type=chunk) - The company has **not finalized its commercial strategy for DARE-BV1** and lacks a commercial partner, which could delay a potential launch[214](index=214&type=chunk)[215](index=215&type=chunk) - The **COVID-19 pandemic remains a risk** that could negatively impact business by increasing costs and timelines for clinical development programs[219](index=219&type=chunk)[223](index=223&type=chunk) - The pivotal Phase 3 study of Ovaprene is **dependent on a CRADA with NICHD**; failure to meet obligations could significantly delay the study[217](index=217&type=chunk) - The sale of common stock in **"at the market" (ATM) offerings** may cause substantial dilution to existing stockholders and could cause the stock price to decline[249](index=249&type=chunk)[250](index=250&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=52&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities were reported during the period - None reported[251](index=251&type=chunk) [Item 3. Defaults Upon Senior Securities](index=52&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported during the period - None reported[251](index=251&type=chunk) [Item 4. Mine Safety Disclosures](index=52&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company's operations - Not applicable[251](index=251&type=chunk) [Item 5. Other Information](index=52&type=section&id=Item%205.%20Other%20Information) No other material information was reported for the period - None reported[251](index=251&type=chunk) [Item 6. Exhibits](index=53&type=section&id=Item%206.%20Exhibits) Exhibits filed include a major grant agreement and officer certifications - Key exhibits filed include the **Grant Agreement with the Bill & Melinda Gates Foundation** effective June 30, 2021, and standard CEO/CFO certifications[254](index=254&type=chunk)

Daré Bioscience, Inc. (NASDAQ:DARE) Q1 2021 Earnings Conference Call May 13, 2021 4:30 PM ET Company Participants Sabrina Martucci Johnson – President and Chief Executive Officer John Fair – Chief Strategy Officer Lisa Walters-Hoffert – Chief Financial Officer Conference Call Participants Zegbeh Jallah – ROTH Capital Partners Chris Bialas – H.C. Wainwright Operator Welcome to the conference call hosted by Daré Bioscience to review the Company’s Financial Results for the Quarter Ended March 31, 2021, and to ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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 March 31, 2021 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 No. 001-36395 20-4139823 (IRS Employer Identification No.) 3655 Nobel Drive, Suite 260 San Diego, CA (Address of Principal Executive Offices) ...

Financial Data and Key Metrics Changes - For the year ended December 31, 2020, the company's general and administrative expenses were approximately $6.5 million, licensed expenses were approximately $83,000, and research and development (R&D) expenses were approximately $20.8 million, leading to a comprehensive loss of approximately $27.4 million [49][50]. - Net cash proceeds from financing activities were approximately $25.1 million, with total cash received during 2020 amounting to approximately $29.5 million, resulting in an ending cash balance of approximately $4.7 million [51][52]. Business Line Data and Key Metrics Changes - The DARE-BV1 program demonstrated a clinical cure rate of 70% in the modified intent to treat population and 77% in the per protocol population, outperforming current branded prescription products for bacterial vaginosis [16][17]. - The Sildenafil cream program commenced its Phase 2b clinical study, with topline data readout targeted for the end of 2021, aiming to address a significant unmet need in female sexual arousal disorder [24][26]. Market Data and Key Metrics Changes - The market for female sexual arousal disorder (FSAD) is estimated to be significant, with approximately 10 million women in the U.S. experiencing distress from symptoms, yet no FDA-approved products currently exist [23]. - The company has established a commercial partnership with Bayer for the Ovaprene product, which includes potential milestone payments and royalties, indicating strong market interest and collaboration [7][27]. Company Strategy and Development Direction - The company focuses on advancing women's health innovation through a portfolio of clinical stage programs in vaginal health, sexual health, contraception, and menopause, aiming to create first-in-category products [6][10]. - The strategic commercialization agreement for DARE-BV1 is expected to be executed before the end of the year, with various partnership structures being considered to maximize shareholder value [41][66]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for DARE-BV1 to become a first-line treatment for bacterial vaginosis, with plans for NDA submission in the second quarter of 2021 [19][39]. - The ongoing COVID-19 pandemic has influenced timelines and operational strategies, but the company remains committed to advancing its clinical programs and partnerships [60][72]. Other Important Information - The company has received grant funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Bill and Melinda Gates Foundation, which supports its R&D activities [56][58]. - The company plans to file a new Form S3 shelf registration statement with the SEC to explore various financing options, enhancing its capital flexibility [54]. Q&A Session Summary Question: What is the expected approval timeline for DARE-BV1 if priority review is not granted? - Management indicated that without priority review, the PDUFA date would likely be towards the end of the first quarter [63]. Question: Will the company prioritize upfront cash in partnerships? - Management emphasized the importance of finding the best partnership structure that maximizes value for shareholders and access to women, rather than solely focusing on upfront cash [65]. Question: What is driving the timing of the IDE for Ovaprene? - The IDE process has been recalibrated due to the COVID-19 pandemic and the need for additional non-clinical work, with a focus on ensuring data availability in 2022 [70][72]. Question: What are the next steps for the Sildenafil cream program following the Phase 2b study? - Following a successful Phase 2b study, the next step would be an end-of-Phase 2 meeting with the FDA to align on the Phase 3 study design [89]. Question: When does the company plan to partner its hormone replacement therapy products? - Management stated that discussions with potential partners are ongoing, and decisions will depend on the specific program and investment appetite [92].

Product Development and Clinical Trials - Daré Bioscience is focused on advancing innovative products for women's health, particularly in contraception, vaginal health, sexual health, and fertility[13]. - The company has a portfolio that includes three product candidates in advanced stages of clinical development and three candidates that are Phase 1-ready[15]. - DARE-BV1, a treatment for bacterial vaginosis, achieved a clinical cure rate of 70.2% at the primary endpoint visit compared to 35.6% for placebo, with a p-value < 0.001[22]. - The NDA submission for DARE-BV1 is planned for the end of Q2 2021, with potential FDA approval and commercial launch expected in early 2022[23]. - Ovaprene, a hormone-free contraceptive, aims for typical use efficacy comparable to current hormonal methods, which is approximately 91%[24]. - DARE-BV1 received Fast Track designation from the FDA, facilitating more frequent interactions regarding its development plan[20]. - The company plans to utilize the FDA's 505(b)(2) pathway for DARE-BV1, leveraging existing safety and efficacy data on clindamycin[20]. - The DARE-BVFREE Phase 3 trial for DARE-BV1 involved 307 women, demonstrating statistically significant efficacy in all pre-specified secondary assessments[22]. - The clinical cure rate for DARE-BV1 in the per protocol population was 77.2%, significantly higher than the placebo group at 42.6%[23]. - Ovaprene demonstrated 100% effectiveness in preventing more than five progressively motile sperm per high power field in cervical mucus across all evaluated cycles[25]. - In the PCT clinical trial, women using Ovaprene had a mean of 0.48 PMS/HPF compared to a baseline mean of 27.21 PMS/HPF when no contraception was used[25]. - Sildenafil Cream, 3.6% showed significant increases in genital blood flow compared to placebo, with measurable changes observed approximately 30 minutes post-dosing[27]. - The Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% is expected to randomize 400 to 590 subjects, targeting a topline data readout by year-end 2021[29]. - DARE-HRT1 is designed for sustained drug delivery over weeks to months, with the potential to be the first FDA-approved IVR delivering bio-identical progesterone and estradiol[30]. - The Phase 1 clinical study of DARE-HRT1 completed enrollment in March 2021, with topline data anticipated in the second quarter of 2021[30]. - DARE-FRT1 is being developed for the prevention of preterm birth and broader luteal phase support, with a Phase 1 clinical trial anticipated to start in 2022[32]. - The FDA's 505(b)(2) pathway will be utilized for marketing approval of both DARE-HRT1 and DARE-FRT1, leveraging existing safety and efficacy data[30][32]. - The PCT clinical trial of Ovaprene is designed to support an IDE submission to the FDA for a pivotal clinical study expected to start in Q1 2022[25]. - The company is conducting ongoing communications with the FDA regarding the trial design and product use to ensure alignment prior to the pivotal study commencement[25]. - DARE-VVA1 is being developed as an alternative to estrogen-based therapies for vulvar and vaginal atrophy (VVA) in women with hormone-receptor positive breast cancer, with an estimated prevalence of VVA in post-menopausal breast cancer patients between 42% and 70%[33]. - The company plans to initiate a Phase 1 clinical trial for DARE-VVA1 in the second half of 2021, contingent on the availability of additional funding[33]. Financial and Capital Resources - The company has paid a total of $235,000 in license fees to MilanaPharm for the development and commercialization of products related to bacterial vaginosis[37]. - Milestone payments to MilanaPharm include up to $300,000 for clinical and regulatory milestones and up to $1.75 million for commercial sales milestones[39]. - The company has a license agreement with ADVA-Tec for Ovaprene, with potential milestone payments totaling up to $14.6 million based on development and regulatory achievements[41]. - Bayer has agreed to a $1.0 million upfront payment and potential milestone payments totaling up to $310 million based on the commercialization of Ovaprene in the U.S.[44]. - The company must meet a minimum spending amount of $5 million over the first three years for Ovaprene development activities[41]. - The license agreement with Bayer will continue until the expiration of any valid claim covering Ovaprene or 15 years from the first commercial sale in the U.S.[44]. - The company entered into a license and collaboration agreement with SST for the development and commercialization of Sildenafil Cream, 3.6%, with a royalty structure based on annual net sales ranging from single digits to mid double digits[45]. - SST is eligible for milestone payments totaling between $0.5 million to $18.0 million for clinical and regulatory achievements, and between $10.0 million to $100 million for commercial sales milestones[46]. - The company acquired Microchips Biotech, Inc. in November 2019, issuing approximately 3.0 million shares and agreeing to pay up to $46.5 million contingent on specified milestones[52][53]. - The contingent consideration for Microchips includes tiered royalty payments ranging from low single-digit to low double-digit percentages of annual net sales of products[53]. - The company has rights to over 100 patents and applications from the Microchips acquisition, with key technology supported by 21 U.S. patents and 42 foreign patents[57]. - The company is the exclusive licensee of 19 issued patents worldwide for Sildenafil Cream, with U.S. patents expiring in June 2029[57]. - The Catalent license agreement includes potential milestone payments of up to $13.5 million for clinical and regulatory milestones and up to $30.3 million for commercial sales milestones[49]. - The company is required to pay an annual maintenance fee of $50,000 for the first two years and $100,000 thereafter under the Catalent agreement[49]. - The company actively seeks to protect its proprietary technology through patents, trade secrets, and contracts[54]. - The company holds a domestic registration for the trademark Daré Bioscience and is the exclusive licensee of the Ovaprene registered trademark[57]. - The company has pre-clinical product candidates in women's health, including DARE-LARC1, ORB-204, ORB-214, and DARE-RH1, aimed at expanding contraceptive options and improving outcomes[59]. - The company incurred a net loss of approximately $27.4 million for the year ended December 31, 2020, with an accumulated deficit of approximately $71.4 million[139]. - As of December 31, 2020, the company's cash and cash equivalents were approximately $4.7 million, indicating a need for additional capital to continue operations[139]. - The company expects to continue incurring net losses for the foreseeable future as it develops and seeks to bring its existing product candidates to market[139]. - The company has not obtained any regulatory approvals or generated any product revenue to date, highlighting its clinical-stage status[141]. - The company may need to raise additional capital through various means, including collaborations and strategic alliances, which could lead to dilution for existing shareholders[139]. - The company may face limitations in raising capital due to SEC regulations, particularly the "baby shelf rule," which restricts capital raising when public float is below $75 million[147]. - The company’s financial and technical resources are limited, potentially affecting the development of its product candidates and leading to delays in clinical trials[149]. - The company may need to curtail clinical development programs due to financial constraints, which could result in missed opportunities for product candidates[149]. - The company expects to incur significant legal, accounting, and compliance expenses as a public reporting entity, which may increase if it becomes an "accelerated filer" with a public float of $75 million or more and annual revenues of $100 million or more[161]. Regulatory Environment and Compliance - The FDA approval process for new drug products is extensive and requires significant time and financial resources, including the submission of detailed safety and efficacy data[65]. - The FDA has a ten-month review period for standard NDAs and six months for priority reviews, although these timelines can be extended due to additional information requests[71]. - The company must comply with rigorous regulatory requirements throughout the drug development process, including preclinical studies and clinical trials[68]. - The company is subject to various government regulations that impact all aspects of pharmaceutical development, including manufacturing and marketing[63]. - The company is committed to developing innovative products that meet unmet medical needs, which may include post-approval trials to gather additional data on product safety and efficacy[70]. - The FDA conducts a preliminary review of all NDAs within 60 days to determine if they are sufficiently complete for substantive review[72]. - The FDA may issue a Complete Response Letter (CRL) indicating that the application will not be approved in its present form, which may require minor or major changes[74]. - Fast track designation allows for more frequent interactions with the FDA and may expedite the development and review process for drugs addressing unmet medical needs[75]. - Priority review designation shortens the FDA's goal for taking action on a marketing application from ten months to six months[77]. - Post-approval, manufacturers must comply with ongoing FDA regulations, including monitoring adverse experiences and maintaining cGMP compliance[78]. - The Drug Supply Chain Security Act (DSCSA) mandates phased-in obligations for pharmaceutical manufacturers and distributors to enhance supply chain security, culminating in November 2023[80]. - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) plan to ensure the benefits of a drug outweigh its risks[72]. - The GAIN Act provides incentives for the development of antibacterial and antifungal drugs, including a five-year exclusivity extension upon FDA approval[75]. - The FDA may impose restrictions on product distribution and labeling based on post-marketing studies or newly discovered safety risks[79]. - Non-compliance with FDA regulations can lead to severe consequences, including product recalls, fines, and withdrawal of product approvals[80]. - Medical devices are classified into three classes by the FDA based on risk, with Class I being low risk, Class II moderate risk, and Class III high risk, requiring different levels of regulatory scrutiny[83]. - Class I devices are mostly exempt from premarket regulation, while Class II devices typically require 510(k) clearance, which aims for a substantial equivalence determination within 90 days[83]. - Class III devices must undergo a premarket approval (PMA) process, which can take between one and three years, and requires extensive data to demonstrate safety and effectiveness[83]. - The FDA has increased scrutiny on cybersecurity risks associated with connected medical devices, impacting the review and marketing authorization process[81]. - The de novo classification procedure allows manufacturers to request down-classification of low to moderate risk devices that are automatically classified as Class III, streamlining the approval process[83]. - Clinical trials are generally required for PMA applications and may also be necessary for 510(k) notifications, with strict regulations governing the conduct of these trials[85]. - Post-marketing requirements for medical devices include compliance with quality system regulations and mandatory reporting of adverse events, similar to prescription drugs[85]. - Manufacturers must report any device malfunctions that could lead to serious injury or death under the FDA's medical device reporting regulations[87]. - The FDA has the authority to require recalls of medical devices if there is a reasonable probability of serious adverse health consequences[87]. - Non-compliance with FDA regulations can result in severe sanctions, including fines, recalls, and delays in product approvals[87]. - Combination products are subject to FDA user fees based on the type of application submitted, such as NDA and PMA fees[90]. - The Hatch-Waxman Act provides a five-year non-patent exclusivity period for the first applicant to gain NDA approval for a new chemical entity (NCE)[94]. - A QIDP designation under the GAIN Act allows for a five-year extension of non-patent marketing exclusivity for approved drugs intended to treat serious infections[96]. - Patent term extensions can restore up to five years for patents lost during product development and FDA review, with a maximum total patent term of 14 years from the product's approval date[97]. - The FDA requires ANDA applicants to certify regarding any patents listed for the reference product in the Orange Book, impacting the approval timeline[93]. - Non-compliance with clinical trial registration and reporting can lead to civil penalties and loss of federal grant eligibility[98]. - The FDA's designation of therapeutic equivalence allows for substitution of generic drugs without physician or patient consent, impacting market dynamics[91]. - The 21st Century Cures Act clarified that Hatch-Waxman Act requirements apply to drug-device combination products, potentially delaying approvals due to patent disputes[90]. - The FDA must determine that a generic drug is bioequivalent to the reference listed drug (RLD) for ANDA approval, affecting market entry[91]. - The FDA's regulations require compliance with cGMP and QSR for combination product manufacturers, ensuring product safety and effectiveness[90]. - The company expects to develop a compliance program to adhere to healthcare laws and regulations, which may involve substantial costs[104]. - The company is subject to state laws governing the privacy and security of health information, complicating compliance efforts[102]. - The company is subject to evolving data privacy laws, including the California Consumer Privacy Act (CCPA) and the California Privacy Rights Act (CPRA), which impose stringent requirements on the handling of personal information[110]. - The FDA Reauthorization Act and other regulatory changes may impact the approval process for product candidates, potentially delaying or preventing market entry[111]. - The 2020 Consolidated Appropriations Act includes the CREATES Act, which allows generic developers to sue brand manufacturers for access to necessary samples, potentially affecting market dynamics[113]. - The company must navigate complex foreign regulatory environments for clinical trials and product approvals, which may differ significantly from U.S. requirements[114]. - The new Clinical Trials Regulation in the EU aims to streamline the approval process, with a maximum evaluation timeframe of 210 days for marketing authorization applications[117]. - The centralized procedure for EU marketing authorization is mandatory for certain products, with a maximum evaluation timeframe of 210 days, and accelerated assessment may be granted in exceptional cases[119]. - The new Medical Device Regulation (MDR) in the EU, effective from May 26, 2021, increases regulatory oversight and may raise costs and requirements for market entry[120]. Market Competition and Commercialization - DARE-BV1, if approved, will compete with existing treatments for bacterial vaginosis, including FDA-approved products like Solosec® and Clindesse®[60]. - The investigational contraceptive product Ovaprene will face competition from a variety of existing contraceptive options, including hormone-free and hormonal products[60]. - The company is developing Sildenafil Cream, 3.6%, which has the potential to be the first FDA-approved treatment for Female Sexual Arousal Disorder (FSAD)[60]. - The company’s ability to successfully market products will depend on factors such as FDA approval, product efficacy, and competition from other organizations[60]. - The commercial success of DARE-BV1 will depend on its effectiveness compared to existing FDA-approved treatments for bacterial vaginosis, which include generic options like clindamycin and metronidazole[181]. - The commercial success of Ovaprene will depend on market acceptance and the effectiveness of Bayer's marketing efforts, as Bayer holds exclusive rights to market and sell the product in the U.S.[184]. - The company faces competition from existing hormone therapies and must demonstrate the efficacy and safety of DARE-HRT1 to gain market acceptance among menopausal women[186]. - The commercial success of Sildenafil Cream, 3.6% will depend on its ability to demonstrate safety and effectiveness in treating female sexual arousal disorder, as well as market acceptance[186]. - The women's health market is increasingly dominated by generic products, making it difficult for the company to introduce new branded products at profitable prices[193]. - The proportion of the U.S. market made up of generic products is rising, which could hinder the company’s ability to achieve acceptable revenue levels from new products[194]. - The company faces uncertainty regarding third-party reimbursement for its products, which could significantly impact market demand and financial prospects[195]. - Changes in health care laws may reduce demand for branded products, leading to a preference for lower-cost generics[194]. - The commercial success of the company’s products will depend on the extent of third-party payor coverage and reimbursement rates[197]. - Legislative efforts to control pharmaceutical pricing may further complicate the company’s ability to market its products profitably[199]. - The Biden Administration's focus on lowering prescription drug prices may impact the company's ability to generate revenue and attain profitability[200]. - The company relies on third-party partners for sales and distribution, which poses risks if these partners fail to effectively market or distribute products[204]. - The commercial success of product candidates is contingent on obtaining FDA approval and favorable product labeling, which is critical for differentiation from competitors[205]. - Many product candidates are in pre-clinical stages, carrying a higher risk of failure and requiring significant safety and efficacy data before advancing to clinical trials[206]. - Macroeconomic factors such as inflation and interest rates could adversely affect the ability of patients and distributors to purchase and distribute products[208]. Operational Challenges and Risks - The company has a limited operating history and has incurred significant losses since inception, expecting to continue incurring losses for the foreseeable future[134]. - The company relies heavily on the success of its lead product candidates, including DARE-BV1, Ovaprene, and Sildenafil Cream, 3.6%, with clinical development being lengthy and expensive[134]. - As of March 29, 2021, the company had 23 employees, with 12 in research and development and 11 in general and administrative roles[130]. - The company must raise additional capital to continue operations, with challenges due to low trading volume, lack of revenue, and limited operating history[134]. - The company is subject to various federal, state, and local environmental, health, and safety laws, which could result in substantial fines if not complied with[129]. - The company may face delays in clinical development programs due to the COVID-19 pandemic, impacting costs and timelines[134]. - The company depends on third parties for significant aspects of product development, and failures by these parties could lead to delays or program failures[134]. - The company must obtain regulatory approvals, particularly from the FDA, for its product candidates, which may require more resources and time than anticipated[134]. - The company has a license agreement with Bayer, but there is a risk of not receiving additional payments, and Bayer may terminate the agreement without cause[134]. - The company is subject to evolving EU laws on data export and must comply with GDPR, which imposes significant penalties for non-compliance[126]. - The company relies on external consultants for product development and operational expertise due to its limited personnel resources[155]. - The company may need to obtain significant additional capital for development or commercialization activities, which may not be available on acceptable terms[154].