Dare Bioscience, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Dare Bioscience, Inc. has filed its 2023 annual report (10-K) detailing its financial performance and business operations.</b>

AI Summary

Dare Bioscience, Inc. (DARE) filed a Annual Report (10-K) with the SEC on March 28, 2024. Dare Bioscience, Inc. filed its 2023 Form 10-K on March 28, 2024. The company's fiscal year ends on December 31. Dare Bioscience was formerly known as Cerulean Pharma Inc. and Tempo Pharmaceuticals Inc. The company is incorporated in Delaware. Dare Bioscience is in the Pharmaceutical Preparations industry (SIC 2834).

Why It Matters

For investors and stakeholders tracking Dare Bioscience, Inc., this filing contains several important signals. This filing provides a comprehensive overview of the company's financial health, strategic initiatives, and risk factors for the fiscal year 2023, crucial for investors to assess its current standing and future prospects. As a 10-K filing, it contains audited financial statements and management's discussion and analysis, offering detailed insights into revenue streams, expenses, and overall business strategy.

Risk Assessment

Risk Level: medium — Dare Bioscience, Inc. shows moderate risk based on this filing. The company operates in the highly competitive and regulated pharmaceutical industry, facing risks related to clinical trial success, regulatory approvals, and market adoption of its products.

Analyst Insight

Investors should review the detailed risk factors and financial statements in the 10-K to understand the specific challenges and opportunities facing Dare Bioscience in the coming year.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-03-28 — Filing Date (Filed as of date)
• 2834 — SIC Code (Standard Industrial Classification)

Key Players & Entities

• Dare Bioscience, Inc. (company) — Filer name
• Cerulean Pharma Inc. (company) — Former company name
• Tempo Pharmaceuticals Inc (company) — Former company name
• 2023-12-31 (date) — Conformed period of report
• 2024-03-28 (date) — Filed as of date
• 2834 (industry_code) — Standard Industrial Classification
• DE (jurisdiction) — State of incorporation
• 3655 NOBEL DRIVE SUITE 260 SAN DIEGO CA 92122 (address) — Business address

FAQ

Industry Context

Dare Bioscience operates within the pharmaceutical preparations industry, focusing on the development and commercialization of female-focused products.

Regulatory Implications

As a pharmaceutical company, Dare Bioscience is subject to extensive regulation by bodies such as the FDA, impacting product development, clinical trials, and market approval processes.

What Investors Should Do

1. Review the full 10-K filing for detailed financial statements and management discussion.
2. Analyze the company's product pipeline and clinical trial progress as described in the report.
3. Assess the identified risk factors and their potential impact on future performance.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-03-28: 10-K Filing Date — Date the annual report was officially submitted to the SEC.

Year-Over-Year Comparison

This is the company's 2023 annual report (10-K) filing, providing updated financial and operational information compared to previous filings.

Key Financial Figures

• $0.0001 — ich registered Common Stock, Par Value $0.0001 Per Share DARE Nasdaq Capital Market

Filing Documents

• dare-20231231.htm (10-K) — 1906KB
• dare-20231231xex44.htm (EX-4.4) — 109KB
• dare-20231231xex1012.htm (EX-10.12) — 404KB
• dare-20231231xex211.htm (EX-21.1) — 4KB
• dare-20231231xex231.htm (EX-23.1) — 3KB
• dare-20231231xex232.htm (EX-23.2) — 3KB
• dare-20231231xex311.htm (EX-31.1) — 8KB
• dare-20231231xex321.htm (EX-32.1) — 4KB
• dare-20231231xex97.htm (EX-97) — 42KB
• dare-20231231_g1.jpg (GRAPHIC) — 128KB
• dare-20231231_g2.jpg (GRAPHIC) — 115KB
• dare-20231231_g3.jpg (GRAPHIC) — 117KB
• 0001401914-24-000016.txt (&nbsp;) — 9616KB
• dare-20231231.xsd (EX-101.SCH) — 65KB
• dare-20231231_cal.xml (EX-101.CAL) — 63KB
• dare-20231231_def.xml (EX-101.DEF) — 333KB
• dare-20231231_lab.xml (EX-101.LAB) — 744KB
• dare-20231231_pre.xml (EX-101.PRE) — 533KB
• dare-20231231_htm.xml (XML) — 733KB

Risk Factors

ITEM 1A. Risk Factors 53

Unresolved Staff Comments

ITEM 1B. Unresolved Staff Comments 105

Cybersecurity

ITEM 1C. Cybersecurity 105

Properties

ITEM 2. Properties 106

Legal Proceedings

ITEM 3. Legal Proceedings 106

Mine Safety Disclosures

ITEM 4. Mine Safety Disclosures 106 PART II 107

Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

ITEM 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 107

Reserved

ITEM 6. Reserved 107

Management's Discussion and Analysis of Financial Condition and Results of Operations

ITEM 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 107

Quantitative and Qualitative Disclosures about Market Risk

ITEM 7A. Quantitative and Qualitative Disclosures about Market Risk 118

Financial Statements and Supplementary Data

ITEM 8. Financial Statements and Supplementary Data 118

Changes in and Disagreement With Accountants on Accounting and Financial Disclosure

ITEM 9. Changes in and Disagreement With Accountants on Accounting and Financial Disclosure 118

Controls and Procedures

ITEM 9A. Controls and Procedures 118

Other Information

ITEM 9B. Other Information 119

Disclosure Regarding Foreign Jurisdictions That Prevent Inspections

ITEM 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections 119 PART III 120

Directors, Executive Officers and Corporate Governance

ITEM 10. Directors, Executive Officers and Corporate Governance 120

Executive Compensation

ITEM 11. Executive Compensation 120

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

ITEM 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 120

Certain Relationships and Related Transactions, and Director Independence

ITEM 13. Certain Relationships and Related Transactions, and Director Independence 120

Principal Accountant Fees and Services

ITEM 14. Principal Accountant Fees and Services 120 PART IV 121

Exhibits and Financial Statement Schedules

ITEM 15. Exhibits and Financial Statement Schedules 121

Form 10-K Summary

ITEM 16. Form 10-K Summary 126

Financial Statements

Financial Statements F- 1 PART I CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K, in particular ITEM 1. "BUSINESS," ITEM 7. "MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS," and the information incorporated by reference herein contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this report, including statements regarding our strategy, future operations, future financial position, projected revenue, funding and expenses, prospects, plans and objectives of management, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "pursue," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including those factors described in PART I, ITEM 1A, "RISK FACTORS," in this report, and elsewhere in this report. Given these uncertainties, you should not place undue reliance on any forward-looking statement. The following factors are among those that may cause such differences: Inability to raise additional capital, under favorable terms or at all, to fund our operating needs and continue as a going concern; The number and scope of product development programs we pursue; Clinical trial outcomes and results of preclinical development; Failure to complete development of our product candidates or submit and obtain United States Food and Drug A

BUSINESS

ITEM 1. BUSINESS The terms "we," "us," "our," "Dar" or the "Company" refer collectively to Dar Bioscience, Inc. and its wholly-owned subsidiaries, unless otherwise stated or the context otherwise requires. All information in this report is based on our fiscal year. Unless otherwise stated, references to particular years, quarters, months or periods refer to our fiscal years ending December 31 and the associated quarters, months and periods of those fiscal years. Overview We are a biopharmaceutical company committed to advancing innovative products for women's health. We are driven by a mission to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women's health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, vaginal health, reproductive health, menopause, sexual health and fertility. Our business strategy is to in-license or otherwise acquire the rights to differentiated product candidates in our areas of focus, some of which have existing clinical proof-of-concept data, to take those candidates through mid to late-stage clinical development or regulatory approval, and to establish and leverage strategic collaborations to achieve commercialization. We and our wholly-owned subsidiaries operate in one business segment. The first FDA-approved product to emerge from our portfolio of women's health product candidates is XACIATO (clindamycin phosphate) vaginal gel 2%, or XACIATO (pronounced zah-she-AH-toe). XACIATO was approved by the FDA in December 2021 as a single-dose prescription medication for the treatment of bacterial vaginosis in females 12 years of age and older. In March 2022, we entered into an agreement with an affiliate of Organon & Co., Organon International GmbH, or Organon, which became fully effective in June 2022, whereby Organon licensed exclusive worldwide rights to develop, manufacture and commercialize XACIATO. Accordingly, our potential f

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View this 10-K filing on SEC EDGAR