SAN DIEGO, Oct. 20, 2025 /PRNewswire/ --Å Evofem Biosciences. Inc. (OTCID: EVFM) ("Evofem" or the "Company"), today announced that at a Special Meeting of Stockholders held this morning, its stockholders did not approve the proposal to adopt the Amended and Restated Merger Agreement dated July 12, 2024, as subsequently amended (the "Merger Agreement"), between the Company, Aditxt, Inc. (NASDAQ: ADTX), and Adifem, Inc., a wholly owned subsidiary of Aditxt, under which Aditxt intended to acquire Evofem. As a ...

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]

Core Viewpoint - Evofem Biosciences reported a 16% increase in net sales for Q2 2025 compared to the same quarter last year, driven by the addition of SOLOSEC and a price increase for PHEXXI, while also improving its loss from operations [2][3][4]. Financial Performance - Net sales for Q2 2025 were $4.8 million, up from $4.2 million in Q2 2024 [3][6]. - Total operating expenses increased to $6.1 million in Q2 2025 from $5.5 million in the prior year [3][7]. - Loss from operations improved to $1.3 million in Q2 2025, compared to $1.4 million in Q2 2024 [4][6]. - Net loss attributable to common stockholders was $1.8 million in Q2 2025, a decline from a net income of $1.3 million in Q2 2024, resulting in a net loss of $(0.02) per share [4][18]. Liquidity and Capital Raising - Evofem raised $2.4 million in net proceeds from the sale of senior subordinated notes and warrants to Aditxt, Inc. in April and June 2025 [5][8]. - As of June 30, 2025, the company had cash and cash equivalents of $0.7 million [8]. Strategic Developments - Evofem is advancing plans for a Special Meeting of Stockholders to approve the A&R Merger Agreement with Aditxt, which will make Evofem a wholly-owned subsidiary of Aditxt [5][11]. - The company is working on reducing manufacturing costs by approximately 50% for PHEXXI and SOLOSEC to enhance profitability and market entry [6]. Market Initiatives - PHEXXI gained significant attention through a viral TikTok campaign, achieving over 7 million views and 24,000+ comments [6]. - Evofem declared August as "Say Vagina Month" to promote awareness and engagement around vaginal health, resulting in a 250% increase in unique visits to Phexxi.com during the campaign's first week [6]. Product Approvals and Trials - PHEXXI has been submitted for marketing approval in the UAE, with SOLOSEC expected to follow in Q3 2025 [6][10]. - Patient recruitment is ongoing for a Phase 4 clinical trial evaluating SOLOSEC's effectiveness compared to metronidazole for treating Trichomonas vaginalis [6].

Core Insights - PHEXXI, a non-hormonal birth control brand, has sparked a national conversation on microfeminism through a viral TikTok with over 10 million views, highlighting women's empowerment and daily practices of microfeminism [1][2][3] - The brand's messaging aligns with the cultural shift towards women's autonomy and choice in health, emphasizing that microfeminism involves small, intentional acts that reclaim equity [3][4] - Evofem Biosciences, the creator of PHEXXI, is focused on addressing unmet needs in women's sexual and reproductive health, with two FDA-approved products generating revenue [5][7] Company Overview - Evofem Biosciences, Inc. is commercializing innovative products for women's sexual and reproductive health, including PHEXXI and SOLOSEC, both of which are FDA-approved [5][7] - The company is in the process of being acquired by Aditxt, which aims to enhance its social innovation platform with a dedicated women's health program, targeting a close in the second half of 2025 [6] Product Details - PHEXXI is the first and only hormone-free, on-demand prescription contraceptive vaginal gel, applied 0-60 minutes before sexual activity, available in boxes of 12 pre-filled applicators [7] - SOLOSEC is an FDA-approved oral antibiotic for treating bacterial vaginosis and trichomoniasis, providing a complete course of therapy in just one dose [7]

Core Insights - Windtree Therapeutics has entered a contract with a Chinese pharmaceutical manufacturer to produce Evofem's PHEXXI, aiming to reduce manufacturing costs by over 50% by the end of 2026 [1][2][3] - The tech transfer process is currently underway, with validation batch manufacturing expected to begin in 2026, which is anticipated to generate revenue for Windtree [2][3] - Evofem has experienced four consecutive years of net sales growth for PHEXXI and is preparing to enter the UAE market in early 2026 [3] Company Developments - The manufacturing contract is part of a broader License and Supply Agreement established in March 2025 between Windtree and Evofem [4] - Windtree aims to become a revenue-generating company across various growing industries, focusing on overall profitability [5]

Core Insights - The market for bacterial vaginosis (BV) treatments in the U.S. is projected to reach $1.0 billion by 2033, driven by increasing incidence, public health awareness, and improved diagnostics [3][4]. Company Overview - Evofem Biosciences, Inc. is focused on women's sexual and reproductive health, with two FDA-approved products generating revenue [8]. - The company relaunched SOLOSEC in November 2024 and is promoting it alongside PHEXXI to OB/GYNs in the U.S. [9]. - Evofem is entering global markets through strategic partnerships, including a license agreement for launching products in the UAE in 2026 [9]. Product Development - SOLOSEC (secnidazole) is being studied for its efficacy in managing recurrent BV, with a recent study showing that once-weekly dosing may match or exceed the effectiveness of current CDC-recommended treatments [2][3]. - The study involved 24 women and indicated that the once-weekly dosing could improve adherence compared to more complex treatment regimens [3][5]. - SOLOSEC is currently approved for treating BV in women aged 12 and older, but its use for recurrent BV is still investigational [5][7]. Market Dynamics - BV affects approximately 21 million women in the U.S., with up to 50% experiencing recurrence within six months of treatment [4][6]. - The high recurrence rate of BV presents a significant burden on patients and the healthcare system, highlighting the need for more effective treatment options [4][6]. Strategic Initiatives - Evofem has entered into a definitive agreement to be acquired by Aditxt, Inc., aiming to enhance its focus on women's health innovations [10].

Core Viewpoint - Evofem Biosciences and Pharma 1 have entered into a License and Supply Agreement for the commercialization of SOLOSEC in the Middle East, targeting regulatory submission in the UAE by mid-2025 [1][2][4] Group 1: Agreement Details - The agreement includes an upfront payment, milestone payments based on regulatory achievements, and sales-based milestone payments to Evofem for the exclusive rights to SOLOSEC in the region [2] - Pharma 1 will be responsible for obtaining regulatory approvals and managing all commercial functions related to SOLOSEC in the Middle East [7] Group 2: Market Opportunity - Bacterial vaginosis (BV) and trichomoniasis are prevalent in the Gulf Cooperation Council (GCC) region, with BV affecting 25% to 41% of women in the MENA region, translating to approximately 1.0 million to 1.7 million women in the UAE alone [4][6] - Trichomoniasis has an estimated prevalence of 4.7% among women in the MENA region, with higher rates in intermediate- and high-risk populations [6] Group 3: Product Information - SOLOSEC is an FDA-approved single-dose oral treatment for BV and trichomoniasis, providing a complete course of therapy in just one dose [11] - The product is manufactured in the United States, which enhances its appeal in markets where quality and regulatory trust are critical [3]

Core Insights - Evofem Biosciences reported a decrease in net sales for Q1 2025, totaling $0.8 million compared to $3.6 million in Q1 2024, attributed to order timing and magnitude shifts for PHEXXI [3][4] - The company achieved a net income of $1.0 million in Q1 2025, a significant improvement from a net loss of $4.9 million in the same quarter of the previous year [4] - Evofem's operating expenses decreased to $0.5 million in Q1 2025 from $6.4 million in Q1 2024, primarily due to reduced research and development costs [3][7] Financial Performance - Net sales for Q1 2025 were $0.8 million, down from $3.6 million in Q1 2024, reflecting a shift in order timing for PHEXXI [3] - Total operating expenses were $0.5 million in Q1 2025, significantly lower than $6.4 million in the prior year [3] - Income from operations was $0.3 million in Q1 2025, compared to a loss of $2.8 million in Q1 2024 [4] Income and Earnings - Net income attributable to common stockholders was $1.0 million in Q1 2025, equating to $0.01 per basic share, compared to a net loss of $4.9 million or $(0.16) per share in Q1 2024 [4][14] - The company recorded a significant reduction in research and development expenses, down by $5.6 million due to successful negotiations with vendors [7] Liquidity and Cash Position - As of March 31, 2025, the company had cash, cash equivalents, and restricted cash totaling $1.1 million, an increase from $0.7 million at the end of 2024 [5] - In April 2025, Evofem raised $1.5 million from the sale of senior subordinated notes and warrants [6][8] Strategic Developments - Evofem is partnering with Windtree Therapeutics to reduce PHEXXI manufacturing costs by 55% to 60% [6] - The company strengthened its intellectual property with the issuance of the 11th U.S. patent for SOLOSEC, extending coverage to 2040 [6] - Evofem is expanding into global markets, including a planned launch of PHEXXI in the UAE in early 2026 through a partnership with Pharma 1 Drug Store LLC [10]