Core Insights - Evofem Biosciences is set to launch PHEXX®, a hormone-free contraceptive vaginal gel, in the UAE by 2026 following favorable pricing certificates from the Emirates Drug Establishment [1][2][3] Group 1: Product Overview - PHEXX® is the first and only locally-acting contraceptive gel approved by the FDA, designed to be applied before intercourse and works by maintaining a vaginal pH that is inhospitable to sperm [4] - The product contains lactic acid, citric acid, and potassium bitartrate, and is applied using a pre-filled applicator [4] Group 2: Market Expansion - The issuance of pricing certificates is a significant step for Evofem to diversify its revenue streams and enter new markets, particularly in the GCC and MENA regions [2][3] - Pharma 1, Evofem's licensee, holds exclusive commercialization rights for PHEXX® and SOLOSEC® in six GCC states and plans to expand into 15 additional countries [3] Group 3: Regulatory and Commercial Strategy - Pharma 1 is responsible for all aspects of distribution, sales, marketing, and regulatory approvals for PHEXX® and SOLOSEC® in the licensed territory [3] - The company aims to submit PHEXX® for marketing approval in other licensed countries following its approval in the UAE [3]

Financial Performance - Net sales increased by 10% to $5.0 million in Q3 2025, compared to $4.5 million in the prior year quarter[4] - Operating income of $1.0 million was reported for Q3 2025, a significant improvement from a loss of $2.4 million in the same quarter last year[8] - Total operating expenses decreased by 42% to $4.0 million in Q3 2025, down from $6.9 million in the prior year quarter[7] - The net loss attributable to common stockholders was $1.7 million in Q3 2025, compared to a net loss of $2.4 million in Q3 2024, equating to a loss of $0.01 per share[9] - Restricted cash increased to $0.8 million as of September 30, 2025, compared to $0.7 million as of December 31, 2024[10] - The company reported a total stockholders' deficit of $75.1 million as of September 30, 2025[16] Cost Management - The company achieved a reduction in manufacturing costs by approximately 50% for both PHEXX and SOLOSEC, enhancing per-unit profit and facilitating entry into price-sensitive global markets[4] Regulatory and Clinical Developments - SOLOSEC was submitted for marketing approval in the UAE in Q3 2025 under a License and Supply Agreement with Pharma 1[4] - The company is conducting a Phase 4 clinical trial for SOLOSEC, hypothesizing a 1.75 lower rate of repeat infections compared to metronidazole[4] Corporate Actions - Evofem terminated the merger agreement with Aditxt following stockholder disapproval on October 20, 2025[5]

Core Insights - Evofem Biosciences reported a 10% increase in net sales for Q3 2025, reaching $5.0 million compared to $4.5 million in the same quarter last year, driven by effective sales strategies and marketing initiatives [2][11] - The company achieved operating income of $1.0 million in Q3 2025, a significant improvement from a loss of $2.4 million in the prior year quarter [4][11] - Total operating expenses decreased by 42% to $4.0 million in Q3 2025 from $6.9 million in the same period last year, primarily due to reduced general and administrative costs and a one-time accounting gain [3][11] Financial Performance - Net loss attributable to common stockholders was $1.7 million in Q3 2025, an improvement from a net loss of $2.4 million in Q3 2024, translating to a loss of $0.01 per share compared to $0.02 per share in the prior year [5][15] - The company had restricted cash of $0.8 million as of September 30, 2025, up from $0.7 million at the end of 2024 [6] Product and Market Developments - Evofem is advancing strategies to reduce manufacturing costs by approximately 50% for its products PHEXX and SOLOSEC, which is expected to enhance profitability and facilitate entry into price-sensitive global markets [11] - SOLOSEC has been submitted for marketing approval in the United Arab Emirates under a licensing agreement, indicating ongoing expansion efforts [11] - Patient recruitment is ongoing for a Phase 4 clinical trial evaluating SOLOSEC's effectiveness compared to metronidazole for treating Trichomonas vaginalis, with promising hypotheses regarding cost-effectiveness [11] Corporate Actions - Following a Special Meeting of Stockholders on October 20, 2025, Evofem terminated its merger agreement with Aditxt after stockholders did not approve the transaction [11]

Financial Performance - Product sales for the three months ended September 30, 2025, were $4.952 million, an increase from $4.496 million in the same period of 2024, representing a growth of approximately 10.2%[18] - The net loss attributable to common stockholders for the three months ended September 30, 2025, was $1.680 million, compared to a net loss of $2.370 million for the same period in 2024, indicating an improvement of approximately 29.2%[18] - Net loss for the three months ended September 30, 2025, was $1,569 million, compared to a loss of $2,365 million for the same period in 2024, representing a 33.5% improvement[21] - For the nine months ended September 30, 2025, the net loss totaled $5,823 million, slightly improved from $6,485 million in the same period of 2024, showing a 10.2% reduction[21] - The company reported a comprehensive loss of $6,681 million for the nine months ended September 30, 2025, compared to $6,485 million in 2024, indicating a 3% increase[21] Operating Expenses - Total operating expenses for the nine months ended September 30, 2025, were $10.595 million, a decrease from $18.932 million in the same period of 2024, reflecting a reduction of about 43.7%[18] - Research and development expenses for the nine months ended September 30, 2025, were $3.819 million, a significant increase compared to $1.196 million in the same period of 2024[18] Cash and Assets - Cash and cash equivalents as of September 30, 2025, were reported at $0, while total current assets decreased to $7.918 million from $13.609 million as of December 31, 2024[16] - The balance of common stock as of June 30, 2025, was $831,424 thousand, an increase from $829,026 thousand as of September 30, 2024[21] - Cash, cash equivalents, and restricted cash at the end of the period were $840,000, up from $722,000 at the end of the previous year[29] Liabilities - Total liabilities as of September 30, 2025, were $83.976 million, a decrease from $90.264 million as of December 31, 2024, showing a reduction of approximately 6.5%[16] - The company has identified material weaknesses in internal controls and is working on remediation efforts[9] - As of September 30, 2025, the Company reported a working capital deficit of $70.3 million and an accumulated deficit of $900.2 million[41] Regulatory and Market Presence - The company anticipates potential changes in regulatory mandates that could impact the coverage of FDA-approved contraceptive products[14] - The company is focused on expanding its market presence and improving its sales and marketing capabilities, particularly after product rebranding efforts[9] Financing and Debt - Interest pertaining to the Baker Notes for the three months ended September 30, 2025, was approximately $2.9 million, and for the nine months ended September 30, 2025, it was approximately $8.5 million[85] - The Baker Notes have a principal amount of up to $25.0 million, with an interest rate of 10.0% per annum[84] - The Company intends to contest the claims of default made by the Designated Agent and Purchasers under the Baker Bros. SPA[110] Inventory and Cost of Goods Sold - The Company expects to significantly reduce its cost of goods sold (COGS) once PHEXX is manufactured under the Windtree License and Supply Agreement[175] - The Company recorded a total of $1.684 million in inventories as of September 30, 2025, compared to $1.577 million as of December 31, 2024[146] Stock and Equity - The Company issued 5,300,000 shares of common stock upon noncash exercise of purchase rights during the reporting period[21] - The Series E-1 Convertible Preferred Stock was authorized to increase from 2,300 to 10,000 shares to facilitate dividend payments in kind, with a conversion price of $0.40 per share[204] - The Series F-1 Shares rank higher than all Common Stock regarding preferences for dividends and distributions upon liquidation[206] Future Outlook - The Company anticipates continuing to incur net losses for the foreseeable future, raising substantial doubt about its ability to continue as a going concern[47] - The Company plans to generate recurring product revenue from PHEXX and SOLOSEC, restructure payables, and seek additional funding through various financing options[45]

Core Points - Evofem Biosciences' shareholders did not approve the merger with Aditxt, leading to the termination of the merger agreement [1] - The company is now focusing on regaining a national stock listing and securing growth capital to achieve sustainable positive EBITDA by 2027 [2] - Evofem has two FDA-approved products: PHEXXI, a hormone-free contraceptive gel, and SOLOSEC, an oral antibiotic for bacterial vaginosis and trichomoniasis [3][5] Company Strategy - The company aims to deliver value for investors and healthcare providers by executing its long-term growth strategy [2] - Collaboration with Aditxt is expected to enhance the commercialization of Mitomic diagnostic tests for women's health conditions [2] Financial Performance - Evofem has experienced four consecutive years of net sales growth as of 2024 [3]

Core Viewpoint - Evofem Biosciences, Inc. has announced that its licensee Pharma 1 has filed for regulatory approval in the UAE to commercialize SOLOSEC, an FDA-approved treatment for bacterial vaginosis and trichomoniasis, targeting a launch in the first half of 2026 [1][2]. Company Overview - Evofem Biosciences focuses on innovative products for women's sexual and reproductive health, generating revenue from two FDA-approved products, SOLOSEC and PHEXXI [9][10]. - Pharma 1, an Emirati healthcare company, holds exclusive commercialization rights for SOLOSEC and PHEXXI in the MENA region, including the UAE, Kuwait, Saudi Arabia, and Qatar [2][13]. Product Details - SOLOSEC is a single-dose oral treatment for bacterial vaginosis and trichomoniasis, providing a complete course of therapy in just one dose [4][11]. - The prevalence of bacterial vaginosis in the MENA region ranges from 25% to 41%, with an estimated 1.0 million to 1.7 million women affected in the UAE alone [4][5]. Market Opportunity - The Gulf Cooperation Council (GCC) region has millions affected by bacterial vaginosis and trichomoniasis, indicating a significant market opportunity for SOLOSEC [2][6]. - The WHO estimated 156.3 million new cases of trichomoniasis globally in 2020, highlighting the ongoing need for effective treatments [5][8]. Strategic Goals - Pharma 1 aims to develop a commercial strategy for SOLOSEC and expects strong reception in the medical community and among patients seeking convenient treatment options [2][3]. - Evofem views this filing as a critical step towards expanding its revenue streams beyond the U.S. market [2][3].

Core Insights - Evofem Biosciences emphasizes the importance of access to contraception for health, future, and freedom on World Contraception Day [1] - The company aims to challenge the status quo in women's health by providing innovative, hormone-free contraceptive options [2][3] - Evofem's commitment includes education and awareness campaigns to reduce stigma around women's health issues [3][4] Product Offerings - PHEXXI is highlighted as the first and only hormone-free, on-demand contraceptive vaginal gel, applied before sexual activity [6] - SOLOSEC is an FDA-approved single-dose oral treatment for bacterial vaginosis and trichomoniasis, targeting women and individuals aged 12 and older [7] Company Vision and Initiatives - Evofem is dedicated to breaking barriers and expanding global access to women's health products [4] - The "Say Vagina" initiative has reached millions, aiming to improve health education and confront stigma [3][10]

Core Insights - Evofem Biosciences, Inc. has successfully concluded its "Say Vagina" campaign, which aimed to normalize clinical anatomical language and combat censorship in medical terminology, resulting in significant engagement and awareness [1][3][9] - The campaign led to a 130% increase in traffic to PHEXXI.com, making PHEXXI the most followed contraceptive brand on social media among healthcare providers [1][9] - Evofem plans to maintain the momentum from the campaign by launching SayVaginaStore.com, with proceeds from merchandise sales going to sexual and reproductive health charities [3] Company Overview - Evofem is focused on commercializing innovative products to address unmet needs in women's sexual and reproductive health, generating revenue from two FDA-approved products: PHEXXI and SOLOSEC [4][6] - PHEXXI is the first and only hormone-free, on-demand prescription contraceptive vaginal gel, while SOLOSEC is an FDA-approved oral antibiotic for treating bacterial vaginosis and trichomoniasis [5][6] Campaign Impact - The "Say Vagina" campaign generated over 2.5 million views across social media platforms and significantly increased engagement with patients, providers, and educators [9] - CEO Saundra Pelletier emphasized the campaign's role in transforming shame into empowerment and fostering open dialogue about women's health [3] Future Plans - Evofem is preparing for a Special Meeting of Stockholders on September 26, 2025, to discuss a merger with Aditxt, Inc., which will result in Evofem becoming a wholly owned subsidiary of Aditxt [8][10][14]

Core Points - Illinois enacted House Bill 3489 on August 15, 2025, allowing pharmacists to prescribe a broader range of contraceptives, including non-hormonal options like PHEXXI, effective January 1, 2026 [1][3][4] - The legislation aims to improve access to contraceptive choices for women in Illinois, addressing individual health needs and preferences [2][3] - PHEXXI is the first hormone-free, on-demand prescription contraceptive vaginal gel, approved by the FDA in May 2020, and is designed to be used before sexual intercourse [5][8] Company Overview - Evofem Biosciences is focused on commercializing innovative products for women's sexual and reproductive health, generating revenue from PHEXXI and SOLOSEC [5] - The company is involved in a merger agreement with Aditxt, Inc. and Adifem, Inc., with a definitive proxy filing expected soon [6] Product Information - PHEXXI is administered vaginally and is designed to be used 0-60 minutes before intercourse, providing a discreet contraceptive method [8][10] - The product is suitable for women of any body mass index (BMI) and has been clinically shown to increase sexual satisfaction [10]

[FORM 10-Q Cover Page](index=1&type=section&id=FORM%2010-Q%20Cover%20Page) Provides basic filing information for the Form 10-Q, identifying the registrant and outstanding common stock shares - Registrant: **Evofem Biosciences, Inc.**[1](index=1&type=chunk) - Filing Period: Quarterly period ended **June 30, 2025**[1](index=1&type=chunk) Registrant Status | Status | Indication | | :--- | :--- | | Large accelerated filer | ☐ | | Accelerated filer | ☐ | | Non-accelerated filer | ☒ | | Smaller reporting company | ☒ | | Emerging growth company | ☐ | - Common stock outstanding as of August 9, 2025: **118,656,354 shares**[5](index=5&type=chunk) [Table of Contents](index=3&type=section&id=Table%20of%20Contents) Indexes the various parts and items of the Form 10-Q, including financial information and other disclosures - The report is structured into **Part I (Financial Information)** and **Part II (Other Information)**[7](index=7&type=chunk) - Part I includes **Financial Statements**, **Management's Discussion and Analysis**, **Quantitative and Qualitative Disclosures About Market Risk**, and **Controls and Procedures**[7](index=7&type=chunk) - Part II includes **Legal Proceedings**, **Risk Factors**, **Unregistered Sales of Equity Securities**, **Defaults Upon Senior Securities**, **Mine Safety Disclosures**, **Other Information**, and **Exhibits**[7](index=7&type=chunk) [FORWARD-LOOKING STATEMENTS](index=4&type=section&id=FORWARD-LOOKING%20STATEMENTS) Outlines forward-looking statements, primarily in MD&A, with a cautionary note on potential material differences in actual results - Forward-looking statements are primarily found in **"Management's Discussion and Analysis of Financial Condition and Results of Operations"**[9](index=9&type=chunk) - Key areas of forward-looking statements include the consummation of the **Merger Agreement**, ability to continue as a **going concern**, commercialization of **SOLOSEC** and **PHEXXI**, remediation of **internal control weaknesses**, ability to **raise capital**, achieve **profitability**, and comply with **debt arrangements**[10](index=10&type=chunk)[15](index=15&type=chunk) - Cautionary statement: **Actual results may differ materially** from projections due to **known and unknown risks and uncertainties**. The company does not assume any obligation to update forward-looking statements, except as required by applicable law[12](index=12&type=chunk) [PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) Presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, and cash flows [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed balance sheets reflect changes in total assets, liabilities, and stockholders' deficit for the period Condensed Consolidated Balance Sheet Highlights (in thousands) | Item | June 30, 2025 | December 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Total current assets | $8,970 | $13,609 | $(4,639) | | Total assets | $14,382 | $23,789 | $(9,407) | | Total current liabilities | $73,893 | $80,448 | $(6,555) | | Total liabilities | $79,212 | $90,264 | $(11,052) | | Total stockholders' deficit | $(69,616) | $(71,257) | $1,641 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Statements of operations show net income/loss and product sales trends for the three and six months ended June 30 Condensed Consolidated Statements of Operations Highlights (in thousands) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Product sales, net | $4,825 | $4,160 | $5,670 | $7,763 | | Total operating expenses | $6,076 | $5,549 | $6,594 | $11,996 | | Loss from operations | $(1,251) | $(1,389) | $(924) | $(4,233) | | Net income (loss) | $(1,784) | $1,351 | $(828) | $(3,458) | | Net income (loss) attributable to common stockholders | $(1,785) | $1,304 | $(832) | $(3,552) | | Basic EPS | $(0.02) | $0.02 | $(0.01) | $(0.07) | | Diluted EPS | $(0.02) | $(0.00) | $(0.01) | $(0.07) | - Product sales, net, increased by **16%** for the three months ended **June 30, 2025**, compared to the prior year, but decreased by **27%** for the six months ended **June 30, 2025**, primarily due to lower **PHEXXI** sales volume, partially offset by **SOLOSEC** addition and increased WAC[19](index=19&type=chunk)[258](index=258&type=chunk)[265](index=265&type=chunk) [Condensed Consolidated Statements of Comprehensive Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Operations) Statements of comprehensive operations detail comprehensive income/loss for the three and six months ended June 30 Condensed Consolidated Statements of Comprehensive Operations Highlights (in thousands) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Net income (loss) | $(1,784) | $1,351 | $(828) | $(3,458) | | Change in fair value of financial instruments attributed to credit risk change | $(573) | $(256) | $74 | $68 | | Comprehensive income (loss) | $(2,357) | $1,095 | $(754) | $(3,390) | [Condensed Consolidated Statements of Convertible and Redeemable Preferred Stock and Stockholders' Deficit](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Convertible%20and%20Redeemable%20Preferred%20Stock%20and%20Stockholders%27%20Deficit) Details changes in convertible and redeemable preferred stock and stockholders' deficit, including stock-based compensation and net income/loss Stockholders' Deficit Changes (in thousands) | Item | Balance as of Dec 31, 2024 | Stock-based compensation | Change in fair value of financial instruments | Series E-1 Shares dividends | Net income (loss) | Balance as of June 30, 2025 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Total Stockholders' Deficit | $(71,257) | $101 | $74 | $(4) | $(828) | $(69,616) | - Issuance of common stock upon noncash exercise of purchase rights added **$1 thousand** to common stock and **$1 thousand** to additional paid-in capital for the six months ended **June 30, 2025**[25](index=25&type=chunk) - Issuance of **Aditxt Notes – Related Party** added **$2,296 thousand** to additional paid-in capital for the six months ended **June 30, 2025**[25](index=25&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Statements of cash flows show net cash used in operating activities and provided by financing activities for the six months ended June 30 Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :--- | :--- | :--- | :--- | | Net cash used in operating activities | $(2,359) | $(1,018) | $(1,341) | | Net cash used in investing activities | $(59) | $(14) | $(45) | | Net cash provided by financing activities | $2,425 | $1,144 | $1,281 | | Net change in cash, cash equivalents and restricted cash | $7 | $112 | $(105) | | Cash, cash equivalents and restricted cash, end of period | $748 | $692 | $56 | - Primary sources of cash from financing activities for the six months ended **June 30, 2025**, included **$2.4 million** from **Aditxt Notes – Related Party** and **$383 thousand** from short-term debt and Notes[29](index=29&type=chunk)[284](index=284&type=chunk) - Primary uses of cash from operating activities for the six months ended **June 30, 2025**, included payments of routine trade payables (**$0.7 million**), contingent liabilities (**$0.4 million**), and inventory purchases (**$0.5 million**)[282](index=282&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations and disclosures for the unaudited financial statements, including going concern risk and accounting policies [1. Description of Business and Basis of Presentation](index=13&type=section&id=1.%20Description%20of%20Business%20and%20Basis%20of%20Presentation) Describes the company's business, commercialized products, and going concern risk, along with management's liquidity plans - **Evofem** commercializes **PHEXXI** (non-hormonal contraceptive vaginal gel, **FDA approved May 2020**) and **SOLOSEC** (single-dose oral antimicrobial for BV and trichomoniasis, **global rights acquired July 2024**, relaunched **November 2024**)[30](index=30&type=chunk)[31](index=31&type=chunk)[32](index=32&type=chunk) - The company's strategy includes global commercialization through partnerships, with **PHEXXI** and **SOLOSEC** licensed in **MENA** to **Pharma 1 Drug Store**. **PHEXXI** was approved in **Nigeria** and submitted for approval in **Mexico, Ethiopia, and Ghana**[33](index=33&type=chunk)[34](index=34&type=chunk)[35](index=35&type=chunk) - The company has incurred operating losses and negative cash flows since inception, with a working capital deficit of **$64.9 million** and an accumulated deficit of **$898.5 million** as of **June 30, 2025**, raising **substantial doubt** about its ability to continue as a **going concern**[42](index=42&type=chunk)[48](index=48&type=chunk) - Management's plans to meet cash flow needs include generating **product revenue**, earning **milestone payments** from **Pharma 1**, **restructuring payables**, and obtaining **additional funding** through the **A&R Merger Agreement with Aditxt**, **non-dilutive financings**, or other partnerships[46](index=46&type=chunk)[48](index=48&type=chunk) - The company's common stock was moved from **OTCQB** to **OTC Pink Current** on **April 23, 2025**, and then to **Over-the-Counter Integrated Disclosure (OTCID)** on **July 1, 2025**, due to non-compliance with minimum bid price requirements[43](index=43&type=chunk)[44](index=44&type=chunk)[45](index=45&type=chunk) [2. Summary of Significant Accounting Policies](index=15&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) Details significant accounting policies, including segment reporting, credit risk, EPS calculations, and recently issued accounting pronouncements - The company operates and manages its business as **one operating segment**, with the CEO as the chief operating decision-maker[52](index=52&type=chunk) - Significant estimates are made for **revenue variable consideration**, **expected credit losses**, **fair value of financial instruments**, **inventory valuation**, and **deferred tax assets**[51](index=51&type=chunk) - The company is subject to credit risk from trade accounts receivable, with its three largest customers accounting for approximately **80%** of gross product sales and **90%** of trade accounts receivable as of **June 30, 2025**[55](index=55&type=chunk)[57](index=57&type=chunk) Potentially Dilutive Securities Excluded from Diluted EPS (in thousands) | Security Type | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Options to purchase common stock | 3,372 | 3,713 | | Warrants to purchase common stock | 263,062,099 | 20,807,539 | | Purchase rights to purchase common stock | 1,513,848,899 | 1,546,948,899 | | Convertible debt | 2,969,614,658 | 2,528,800,006 | | Series E-1 Shares | 149,350,650 | 127,801,537 | | Series F-1 Shares | 1,706,493,507 | 1,446,753,247 | | Total | 6,602,373,185 | 5,671,114,941 | - **No significant new accounting standards** were adopted during the six months ended **June 30, 2025**. Several ASUs (**2023-06, 2023-09, 2024-03, 2025-01, 2024-04, 2025-05**) are issued but not yet effective, and the company is evaluating their potential impact[65](index=65&type=chunk)[67](index=67&type=chunk)[68](index=68&type=chunk)[69](index=69&type=chunk)[70](index=70&type=chunk)[71](index=71&type=chunk) [3. Revenue](index=17&type=section&id=3.%20Revenue) Explains revenue recognition from product sales, adjusted for various variable considerations based on historical data and market information - Revenue is recognized when control of **PHEXXI** and **SOLOSEC** is transferred to the customer, typically upon receipt[74](index=74&type=chunk) - Revenue is recorded net of reserves for **variable consideration**, including distribution service fees, prompt pay and other discounts, product returns, chargebacks, rebates, and patient support programs[76](index=76&type=chunk)[84](index=84&type=chunk) Variable Consideration Recorded (in millions) | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Contra trade accounts receivable | $0.1 | $0.3 | | Other current liabilities | $7.4 | $7.2 | [4. Debt](index=19&type=section&id=4.%20Debt) Details various debt instruments, including Baker Notes, Adjuvant Notes, SSNs, and Aditxt Notes, and related default situations - **Baker Notes** (originally **$25.0 million** principal) are now held by **Future Pak, LLC**, and are subject to a **Notice of Event of Default** from **September 2024**, claiming acceleration of repayment of the outstanding balance (approximately **$107.0 million**). The company disputes this claim[87](index=87&type=chunk)[106](index=106&type=chunk)[108](index=108&type=chunk)[109](index=109&type=chunk)[111](index=111&type=chunk)[112](index=112&type=chunk) - **Adjuvant Notes** (**$25.0 million** principal) are unsecured convertible promissory notes with a **7.5%** annual interest rate, convertible into common stock. The company was in default as of **September 30, 2023**, but Adjuvant forbore the default[114](index=114&type=chunk)[115](index=115&type=chunk)[116](index=116&type=chunk)[119](index=119&type=chunk)[121](index=121&type=chunk)[122](index=122&type=chunk) - The company issued **Senior Subordinated Notes (SSNs)** and **Aditxt Notes** (total principal **$3.7 million** from **April-June 2025**) with warrants, which are unsecured senior subordinated notes with an **8%** interest rate (subject to increase to **12%** upon default) and a **three-year maturity**[124](index=124&type=chunk)[125](index=125&type=chunk)[129](index=129&type=chunk)[130](index=130&type=chunk)[131](index=131&type=chunk)[132](index=132&type=chunk) Summary of SSNs and Aditxt Notes at Issuance (in thousands) | Notes | Principal At Issuance | Net Proceeds Before Issuance costs | Common Warrants | Maturity Date | Conversion Price At Issuance | Conversion Price At 6/30/2025 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | December 2022 Notes | $2,308 | $1,500 | 369,230 | 12/21/2025 | $6.25 | $0.0154 | | February 2023 Notes | $1,385 | $900 | 653,538 | 2/17/2026 | $2.50 | $0.0154 | | March 2023 Notes | $600 | $390 | 240,000 | 3/17/2026 | $2.50 | $0.0154 | | March 2023 Notes | $538 | $350 | 258,584 | 3/20/2026 | $2.50 | $0.0154 | | April 2023 Notes | $769 | $500 | 615,384 | 3/6/2026 | $1.25 | $0.0154 | | July 2023 Notes | $1,500 | $975 | 1,200,000 | 3/6/2026 | $1.25 | $0.0154 | | August 2023 Notes | $1,000 | $650 | 799,999 | 8/4/2026 | $1.25 | $0.0154 | | September 2023 Notes | $2,885 | $1,875 | 26,997,041 | 9/26/2026 | $0.13 | $0.0154 | | Aditxt April Note | $2,308 | $1,500 | 149,850,150 | 4/8/2028 | $0.0154 | $0.0154 | | Aditxt June Note | $1,423 | $925 | 92,407,592 | 6/26/2028 | $0.0154 | $0.0154 | - The company entered into an insurance premium finance agreement in **June 2025** for **$0.4 million** at **7.82%** annual interest, recorded as short-term debt[137](index=137&type=chunk) [5. Balance Sheet Details](index=28&type=section&id=5.%20Balance%20Sheet%20Details) Provides a breakdown of specific balance sheet accounts, including inventories, prepaid assets, intangible assets, and accrued expenses Inventories (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Raw materials | $111 | $350 | | Work in process | $752 | $982 | | Finished goods | $1,043 | $245 | | Total | $1,906 | $1,577 | Prepaid and Other Current Assets (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Insurance | $868 | $391 | | PDUFA fees | $202 | $606 | | Outside service retainers | $90 | $160 | | Short-term deposits | $125 | $127 | | Other | $97 | $175 | | Total | $1,382 | $1,459 | Intangible Asset, Net (in thousands) | Item | Useful Life | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | :--- | | Intellectual property | 16 years | $5,688 | $10,216 | | Less: accumulated amortization | | $(950) | $(619) | | Total, net | | $4,738 | $9,597 | - The intangible asset, related to the **SOLOSEC acquisition**, decreased by **$4.5 million** for the six months ended **June 30, 2025**, due to fair value adjustments[142](index=142&type=chunk) Accrued Expenses (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Clinical trial related costs | $- | $2,498 | | Accrued royalty | $1,962 | $1,976 | | Accrued compensation for non-employee directors | $627 | $505 | | Other | $738 | $530 | | Total | $3,327 | $5,509 | [6. Fair Value of Financial Instruments](index=29&type=section&id=6.%20Fair%20Value%20of%20Financial%20Instruments) Details fair value measurements of financial liabilities, including convertible debt and derivative liabilities, primarily classified as Level 3 Fair Value of Convertible Debt Instruments (in thousands) | Debt Instrument | Fair Value (June 30, 2025) | Fair Value (December 31, 2024) | Leveling | | :--- | :--- | :--- | :--- | | Baker Notes | $14,609 | $13,801 | Level 3 | | December 2022 Notes | $14 | $118 | Level 3 | | February 2023 Notes | $14 | $120 | Level 3 | | March 2023 Notes | $17 | $147 | Level 3 | | April 2023 Notes | $12 | $108 | Level 3 | | July 2023 Notes | $19 | $161 | Level 3 | | August 2023 Notes | $16 | $136 | Level 3 | | September 2023 Notes | $45 | $383 | Level 3 | | Aditxt Notes | $35 | $- | Level 3 | | Total Fair Value | $14,781 | $14,974 | N/A | Derivative Liabilities (in thousands) | Item | Fair Value (June 30, 2025) | Fair Value (December 31, 2024) | Leveling | | :--- | :--- | :--- | :--- | | Purchase rights | $3 | $1,359 | Level 3 | | Total derivative liabilities | $3 | $1,359 | N/A | - The fair value of **Baker Notes** increased by **$1.0 million** for the six months ended **June 30, 2025**, while total **SSNs** and **Aditxt Notes** decreased by **$1.1 million**[146](index=146&type=chunk) - **Derivative liabilities (purchase rights)** decreased significantly from **$1.359 million** at **December 31, 2024**, to **$3 thousand** at **June 30, 2025**, primarily due to a change in fair value presented in the condensed consolidated statements of operations[146](index=146&type=chunk)[148](index=148&type=chunk) - Valuation methodologies for **Baker Notes**, **SSNs**, **Aditxt Notes**, and **Purchase Rights** involve **Monte Carlo simulations** and **Option-Pricing Models (OPM)** using **Level 3 assumptions**, including future revenues, discount rates, and expected volatility[149](index=149&type=chunk)[150](index=150&type=chunk)[151](index=151&type=chunk) - The **SOLOSEC asset acquisition intangible asset** and **contingent liabilities** are valued using a **Monte Carlo simulation model**, with changes in fair value recorded as adjustments to both the contingent liabilities and the **SOLOSEC IP intangible asset**[153](index=153&type=chunk)[154](index=154&type=chunk)[155](index=155&type=chunk)[156](index=156&type=chunk) [7. Commitments and Contingencies](index=34&type=section&id=7.%20Commitments%20and%20Contingencies) Outlines various commitments and contingencies, including SOLOSEC acquisition obligations, leases, and legal proceedings - The **SOLOSEC acquisition** was accounted for as an **asset acquisition**, with future sales-based payments recorded as **contingent liabilities** and total consideration as an **intangible asset**[157](index=157&type=chunk) - Commitments related to **SOLOSEC** include purchasing finished goods inventory from the seller through **November 2026** (expected **$3.5 million** total, **$0.4 million** in **H1 2025**) and quarterly royalty payments based on net revenue (immaterial in **H1 2025**)[158](index=158&type=chunk)[159](index=159&type=chunk) SOLOSEC Contingent Liabilities (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Contingent liabilities – current | $100 | $700 | | Contingent liabilities – noncurrent | $4,900 | $9,700 | - The company leases **20 vehicles** under operating leases, with a weighted average remaining lease term of **1.83 years** and a weighted average discount rate of **12%** as of **June 30, 2025**[161](index=161&type=chunk)[164](index=164&type=chunk) - A supply and manufacturing agreement for **PHEXXI** resulted in **$0.8 million** in purchases for the six months ended **June 30, 2025**[165](index=165&type=chunk) - The company entered into a **License and Supply Agreement** with **Windtree Therapeutics, Inc.** (a related party) to manufacture **PHEXXI**, expecting to **significantly reduce COGS**. No transactions have occurred yet[166](index=166&type=chunk) - The company is involved in a **trademark dispute** with **TherapeuticsMD, Inc.**, requiring a **PHEXXI name change**. The company failed to meet the original settlement timeline but received **FDA approval** for a new name in **April 2025**. Accrued settlement amounts are **$0.4 million** as of **June 30, 2025**[171](index=171&type=chunk) - The company received multiple **notices of default** from **Future Pak, LLC** (holder of **Baker Notes**) claiming events of default and acceleration of repayment, which the company **strongly disputes**[173](index=173&type=chunk)[174](index=174&type=chunk)[175](index=175&type=chunk) - The **U.S. patent** licensed from **Rush University** for **PHEXXI** expired on **March 6, 2025**, ending royalty obligations to **Rush University**. **PHEXXI** remains protected by **four additional Orange Book patents** solely owned by **Evofem**[176](index=176&type=chunk)[177](index=177&type=chunk) [8. Convertible and Redeemable Preferred Stock and Stockholders' Deficit](index=39&type=section&id=8.%20Convertible%20and%20Redeemable%20Preferred%20Stock%20and%20Stockholders%27%20Deficit) Details outstanding warrants, preferred stock, common stock, and purchase rights, including changes in authorized shares - As of **June 30, 2025**, **263,062,099 warrants** to purchase common stock remain outstanding at a weighted average exercise price of **$0.18 per share**[183](index=183&type=chunk) - The **A&R E-1 Certificate of Designations**, effective **September 30, 2025**, increases authorized **Series E-1 Preferred Stock** from **2,300** to **10,000 shares** to allow for in-kind dividend payments. **Series E-1 shares** are convertible at **$0.0154 per share** as of **June 30, 2025**[185](index=185&type=chunk)[186](index=186&type=chunk) - **Series F-1 Preferred Stock** (**26,280 shares outstanding**) is convertible at **$0.0154 per share** and is held by **Aditxt**[187](index=187&type=chunk)[188](index=188&type=chunk) - The number of authorized common stock shares was increased to **3,000,000,000** effective **September 14, 2023**[190](index=190&type=chunk) - **Purchase Rights** for **1,513,848,899 shares** of common stock remain outstanding as of **June 30, 2025**, expiring **June 28, 2027**[192](index=192&type=chunk) Common Stock Reserved for Future Issuance (as of June 30, 2025) | Item | Common Equivalent Shares | | :--- | :--- | | Common stock issuable upon the exercise of stock options outstanding | 3,372 | | Common stock issuable upon the exercise of common stock warrants | 10,595,019 | | Common stock available for future issuance under the 2019 ESPP | 509 | | Common stock available for future issuance under the Amended and Restated 2014 Plan | 5,789 | | Common stock available for future issuance under the Amended Inducement Plan | 609 | | Common stock reserved for the exercise of purchase rights | 741,490,642 | | Common stock reserved for the conversion of convertible notes | 413,458,756 | | Common stock reserved for the conversion of series E-1 preferred stock | 59,319,137 | | Total common stock reserved for future issuance | 1,224,873,833 | [9. Stock-based Compensation](index=45&type=section&id=9.%20Stock-based%20Compensation) Reports stock-based compensation expense for the three and six months ended June 30, and unrecognized compensation for employee stock options Stock-based Compensation Expense (in thousands) | Expense Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $- | $10 | $1 | $26 | | Selling and marketing | $2 | $24 | $5 | $59 | | General and administrative | $29 | $185 | $95 | $371 | | Total | $31 | $219 | $101 | $456 | - Unrecognized stock-based compensation expense for employee stock options was approximately **$0.1 million** as of **June 30, 2025**, with a weighted-average remaining recognition period of **0.2 years**[196](index=196&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=46&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's perspective on financial condition, operations, commercial strategies, and liquidity challenges, including the Aditxt merger [Overview](index=46&type=section&id=Overview) Provides an overview of Evofem's commercial-stage focus on women's health products, PHEXXI and SOLOSEC, and global expansion strategies - **Evofem** commercializes **PHEXXI**, the first and only non-hormonal prescription contraceptive vaginal gel, and **SOLOSEC**, an **FDA-approved single-dose oral antimicrobial** for **bacterial vaginosis (BV)** and **trichomoniasis**[199](index=199&type=chunk)[200](index=200&type=chunk)[202](index=202&type=chunk) - **PHEXXI** has achieved **net sales growth** in each consecutive year since its **September 2020** launch, with **2025 growth drivers** including social media campaigns, medical conferences, and expanding use with **GLP-1 prescription medications**[201](index=201&type=chunk) - The company acquired **global rights to SOLOSEC** in **July 2024** and relaunched the brand in **November 2024**, leveraging existing commercial infrastructure[202](index=202&type=chunk) - Global expansion is pursued through ex-U.S. partnerships, with **PHEXXI** and **SOLOSEC** licensed to **Pharma 1** in **MENA**, and **PHEXXI** approved in **Nigeria** and submitted for approval in **Mexico, Ethiopia, and Ghana**[203](index=203&type=chunk)[204](index=204&type=chunk)[205](index=205&type=chunk)[206](index=206&type=chunk) - A **Phase 4 clinical trial** for **SOLOSEC**, funded by **NIH**, is underway to evaluate its efficacy and cost-effectiveness against metronidazole for trichomoniasis in men and women[207](index=207&type=chunk)[208](index=208&type=chunk) [Recent Developments](index=48&type=section&id=Recent%20Developments) Highlights recent developments including stock market tier changes, preferred stock adjustments, Aditxt Notes issuance, and merger agreement amendments - Company's common stock began trading on the **Over-the-Counter Integrated Disclosure (OTCID)** market tier on **July 1, 2025**[209](index=209&type=chunk) - Authorized shares of **Series E-1 Preferred Stock** increased from **2,300** to **10,000**, effective **September 30, 2025**, to allow for in-kind dividend payments[210](index=210&type=chunk) - Issued **Aditxt April Note ($2.3 million principal)** and **Aditxt June Note ($1.4 million principal)** with warrants, generating approximately **$2.4 million** in net proceeds[211](index=211&type=chunk)[212](index=212&type=chunk)[213](index=213&type=chunk) - The **A&R Merger Agreement with Aditxt** has been amended **five times**, with the latest amendment (**March 22, 2025**) extending the consummation date to **September 30, 2025**, and including a **$1.5 million Fifth Parent Investment**[215](index=215&type=chunk)[216](index=216&type=chunk)[225](index=225&type=chunk) - A condition of the merger closing is the full payment of the **Baker Notes** outstanding balance, not to exceed the Repurchase Price[226](index=226&type=chunk) [PHEXXI as a Contraceptive; Commercial Strategies](index=50&type=section&id=PHEXXI%20as%20a%20Contraceptive%3B%20Commercial%20Strategies) Details PHEXXI's promotion, commercial strategies for 2025, and efforts to increase access through pharmacy partnerships and government programs - **PHEXXI** is a non-hormonal prescription contraceptive vaginal gel, launched in **September 2020**, promoted to HCPs and available via telehealth[228](index=228&type=chunk) - Key **growth drivers for 2025** include social media campaigns, strategic medical conferences, and expanding use in women taking **GLP-1 medications** (e.g., Ozempic, Mounjaro, Zepbound) where oral birth control may be less effective[201](index=201&type=chunk)[231](index=231&type=chunk) - The company is focusing on **pharmacy partnerships** to increase access, having expanded its network with a major national chain and two regional partners[233](index=233&type=chunk) - **PHEXXI** is covered by a major PBM (**46 million lives**) and the U.S. Department of Veterans Affairs (**13.7 million lives**). The company participates in **Medicaid** and **340B programs**, with approximately **83%** of commercial and Medicaid **PHEXXI** prescriptions approved by payers[234](index=234&type=chunk)[235](index=235&type=chunk)[236](index=236&type=chunk) - Effective **January 1, 2023**, most insurers and PBMs must provide **$0 out-of-pocket coverage** for **FDA-approved contraceptives** like **PHEXXI**[236](index=236&type=chunk) [SOLOSEC](index=52&type=section&id=SOLOSEC) Describes SOLOSEC as an FDA-approved single-dose antimicrobial for BV and trichomoniasis, emphasizing its efficacy and compliance benefits - **SOLOSEC** is an **FDA-approved single-dose oral antimicrobial** for **bacterial vaginosis (BV)** and **Trichomonas vaginalis (trichomoniasis)** in individuals **12 years** and older[238](index=238&type=chunk)[248](index=248&type=chunk) - **BV** affects an estimated **21 million women** in the U.S. and is associated with increased risk of STIs and other health complications if untreated[239](index=239&type=chunk)[240](index=240&type=chunk) - **SOLOSEC** demonstrated **clinically and statistically significant efficacy** for **BV** (**68%** did not require additional treatment) and a **92.2% cure rate** for trichomoniasis in women in clinical trials[242](index=242&type=chunk)[245](index=245&type=chunk) - A **single-dose regimen** is a significant differentiator for **SOLOSEC**, addressing non-compliance issues common with multi-day treatments for **BV** and **trichomoniasis**[241](index=241&type=chunk)[245](index=245&type=chunk) - An investigator-led **Phase 4 clinical trial**, funded by **NIH**, is evaluating **SOLOSEC's** efficacy and cost-effectiveness for trichomoniasis in men and women against multi-dose metronidazole[246](index=246&type=chunk) [Financial Operations Overview](index=52&type=section&id=Financial%20Operations%20Overview) Outlines revenue recognition, operating expenses (COGS, R&D, S&M, G&A), and other income/expense components of the company's financial operations - Revenue is recognized from unit shipments of **PHEXXI** and **SOLOSEC**, adjusted for **variable consideration** like patient support programs[249](index=249&type=chunk) - Cost of goods sold includes purchased materials, direct labor, and manufacturing overhead. **Rush royalty payments ended** due to patent expiration, but quarterly royalties are now paid under the **SOLOSEC Asset Purchase Agreement**[250](index=250&type=chunk)[251](index=251&type=chunk) - Research and development expenses focus on continuous improvements, product characterization, and raw material evaluation, with **no significant investment in clinical development** anticipated for the foreseeable future[253](index=253&type=chunk) - Selling and marketing expenses cover **PHEXXI** and **SOLOSEC commercialization**, telehealth platform, training, and **PDUFA fees**. General and administrative expenses include salaries, benefits, business development, investor relations, and professional fees[254](index=254&type=chunk)[255](index=255&type=chunk) - Other income (expense) primarily consists of **interest expense** and **fair value adjustments of financial instruments**[256](index=256&type=chunk) [Results of Operations](index=55&type=section&id=Results%20of%20Operations) Provides a comparative analysis of financial performance for the three and six months ended June 30, detailing changes in sales and expenses [Three Months Ended June 30, 2025 Compared to Three Months Ended June 30, 2024](index=55&type=section&id=Three%20Months%20Ended%20June%2030%2C%202025%20Compared%20to%20Three%20Months%20Ended%20June%2030%2C%202024) Compares financial performance for the three months ended June 30, 2025, versus 2024, highlighting changes in sales, expenses, and other income Financial Performance (Three Months Ended June 30, in thousands) | Item | 2025 | 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Product sales, net | $4,825 | $4,160 | $665 | 16% | | Cost of goods sold | $755 | $769 | $(14) | (2)% | | Research and development, net | $746 | $270 | $476 | 176% | | Selling and marketing | $2,625 | $2,243 | $382 | 17% | | General and administrative | $1,843 | $2,267 | $(424) | (19)% | | Total other income (expense), net | $(526) | $2,748 | $(3,274) | (119)% | - Increase in R&D expenses primarily due to a **$0.3 million increase** in outside services and a **$0.1 million increase** in facilities costs[260](index=260&type=chunk) - Increase in S&M expenses primarily due to a **$0.3 million increase** related to the **PDUFA fee for SOLOSEC**[261](index=261&type=chunk) [Six Months Ended June 30, 2025 Compared to Six Months Ended June 30, 2024](index=56&type=section&id=Six%20Months%20Ended%20June%2030%2C%202025%20Compared%20to%20Six%20Months%20Ended%20June%2030%2C%202024) Compares financial performance for the six months ended June 30, 2025, versus 2024, detailing changes in sales, expenses, and other income Financial Performance (Six Months Ended June 30, in thousands) | Item | 2025 | 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Product sales, net | $5,670 | $7,763 | $(2,093) | (27)% | | Cost of goods sold | $1,120 | $1,453 | $(333) | (23)% | | Research and development, net | $(4,289) | $864 | $(5,153) | (596)% | | Selling and marketing | $5,225 | $4,588 | $637 | 14% | | General and administrative | $4,208 | $5,091 | $(883) | (17)% | | Total other income, net | $103 | $783 | $(680) | (87)% | - Decrease in R&D expenses primarily due to a **$5.6 million reduction** from trade payable negotiations and a **$0.2 million decrease** in personnel costs, partially offset by a **$0.6 million increase** in facilities and outside services[267](index=267&type=chunk) - Decrease in total other income, net, due to a lower **gain on the change in fair value of financial instruments** (**$1.4 million** in **2025** vs. **$4.1 million** in **2024**) and the absence of a **$1.1 million gain on debt extinguishment** in **2025**[271](index=271&type=chunk)[272](index=272&type=chunk) [Liquidity and Capital Resources](index=58&type=section&id=Liquidity%20and%20Capital%20Resources) Discusses the company's working capital deficit, accumulated deficit, cash position, and management's plans to address going concern risk - As of **June 30, 2025**, the company had a **working capital deficit of $64.9 million** and an **accumulated deficit of $898.5 million**[274](index=274&type=chunk) - Cash and cash equivalents were **$0.7 million** as of **June 30, 2025**, all of which is **restricted cash**, deemed **insufficient to fund operations for the next 12 months**, raising **substantial doubt** about the company's ability to continue as a **going concern**[274](index=274&type=chunk)[278](index=278&type=chunk) - Management's plans to meet cash flow needs include generating revenue from **PHEXXI** and **SOLOSEC**, **restructuring current payables**, and obtaining **additional funding** through capital stock issuance, **non-dilutive financings**, collaborations, or business combinations (e.g., **Aditxt merger**)[277](index=277&type=chunk) - The company's independent registered public accounting firm's opinion on **2024** and **2023** audited financial statements includes an explanatory paragraph regarding **substantial doubt about its ability to continue as a going concern**[281](index=281&type=chunk) Summary Statement of Cash Flows (Six Months Ended June 30, in thousands) | Cash Flow Activity | 2025 | 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Net cash used in operating activities | $(2,359) | $(1,018) | $(1,341) | (132)% | | Net cash used in investing activities | $(59) | $(14) | $(45) | (321)% | | Net cash provided by financing activities | $2,425 | $1,144 | $1,281 | 112% | | Net change in cash, cash equivalents and restricted cash | $7 | $112 | $(105) | (94)% | [Contractual Obligations and Commitments](index=60&type=section&id=Contractual%20Obligations%20and%20Commitments) Outlines the company's contractual obligations, including operating leases, PHEXXI supply agreements, and SOLOSEC acquisition commitments - **Operating lease right-of-use assets** and **lease liabilities** were **$0.2 million** as of **June 30, 2025**[286](index=286&type=chunk) - Purchases under the **PHEXXI supply and manufacturing agreement** were **$0.8 million** for the six months ended **June 30, 2025**[287](index=287&type=chunk) - Commitments related to the **SOLOSEC asset acquisition** include inventory purchases through **November 2026** and **contingent liabilities** and quarterly royalties based on **SOLOSEC net revenue**[288](index=288&type=chunk) - **Royalty costs** to **Rush University** for **PHEXXI** ended for the three and six months ended **June 30, 2025**, due to the expiration of the **Rush patent**[289](index=289&type=chunk) [Other Matters](index=60&type=section&id=Other%20Matters) Refers to Note 2 for accounting pronouncements and confirms no material changes to critical accounting policies since the 2024 Form 10-K - Information on **recently issued accounting pronouncements** is provided in **Note 2**[290](index=290&type=chunk) - **No material changes** to **critical accounting policies** since the **2024 Form 10-K**[291](index=291&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=60&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) States that no quantitative and qualitative disclosures about market risk are applicable for the reporting period - **Not applicable** for this reporting period[292](index=292&type=chunk) [Item 4. Controls and Procedures](index=60&type=section&id=Item%204.%20Controls%20and%20Procedures) Concludes that disclosure controls and procedures were ineffective due to material weaknesses, with ongoing remediation efforts - CEO and CFO concluded that disclosure controls and procedures were **not effective** as of **June 30, 2025**, due to **material weaknesses in internal control over financial reporting**[294](index=294&type=chunk) - Management believes the condensed consolidated financial statements **fairly present** the financial condition, results of operations, and cash flows in all material respects, despite the ineffective controls[295](index=295&type=chunk) - **Remediation activities** for identified material weaknesses are ongoing, but there is no assurance of completion or prevention of future weaknesses[296](index=296&type=chunk) - **No material changes** in internal control over financial reporting occurred during the latest fiscal quarter, apart from ongoing remediation activities[297](index=297&type=chunk) [PART II. OTHER INFORMATION](index=62&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=62&type=section&id=Item%201.%20Legal%20Proceedings) Refers to Note 7 for disclosures regarding legal proceedings, indicating relevant information is provided within the financial statement notes - Refer to **Note 7 - Commitments and Contingencies** for disclosures on legal proceedings[300](index=300&type=chunk) [Item 1A. Risk Factors](index=62&type=section&id=Item%201A.%20Risk%20Factors) States that there have been no material changes to the risk factors disclosed in the company's Form 10-K for the year ended December 31, 2024 - **No material changes** to risk factors since the **Form 10-K for the year ended December 31, 2024**[301](index=301&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=62&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Indicates that there were no unregistered sales of equity securities or use of proceeds to report for the period - **None to report**[302](index=302&type=chunk) [Item 3. Defaults Upon Senior Securities](index=62&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Confirms that the company does not have any defaults on any Senior Securities as of the filing date - **No defaults** on any **Senior Securities** as of the filing date[303](index=303&type=chunk) [Item 4. Mine Safety Disclosures](index=62&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) States that mine safety disclosures are not applicable to the company - **Not applicable**[304](index=304&type=chunk) [Item 5. Other Information](index=62&type=section&id=Item%205.%20Other%20Information) Reports no Rule 10b5-1 or non-Rule 10b5-1 trading arrangements by directors or officers during the three months ended June 30, 2025 - **No Rule 10b5-1 or non-Rule 10b5-1 trading arrangements** were entered into, modified, or terminated by directors or officers during the three months ended **June 30, 2025**[305](index=305&type=chunk) [Item 6. Exhibits](index=62&type=section&id=Item%206.%20Exhibits) Lists the exhibits filed as part of the Form 10-Q, including merger amendments, agreements, and certifications - The exhibit index includes **amendments to the Amended and Restated Plan of Merger**, **License and Supply Agreements**, **Securities Purchase Agreements**, and **certifications** (e.g., **31.1, 31.2, 32.1**)[308](index=308&type=chunk)[310](index=310&type=chunk) - **Financial information** in **XBRL format** is furnished electronically[311](index=311&type=chunk) [Signatures](index=64&type=section&id=Signatures) Contains the required signatures for the Form 10-Q, certifying its submission pursuant to the Securities Exchange Act of 1934 - Report signed by **Ivy Zhang, Chief Financial Officer** (**Principal Financial Officer and Principal Accounting Officer**) on **August 14, 2025**[316](index=316&type=chunk)