Evofem Bioscienc Stock Price, News & Analysis

Evofem Biosciences (OTCID: EVFM) announced that a new U.S. patent for SOLOSEC®, their single-dose oral treatment for bacterial vaginosis and trichomoniasis, has been listed in the FDA Orange Book. The newly listed patent (No. 12,280,037) covers the method, pharmaceutical composition, and use in treating trichomoniasis, extending market exclusivity until December 2041.

SOLOSEC is notable as the first and only FDA-approved single-dose oral treatment for both bacterial vaginosis and trichomoniasis. The company is currently conducting a Phase 4 clinical trial comparing SOLOSEC's effectiveness and cost-effectiveness against metronidazole in treating T. vaginalis infections, which affect an estimated 6.9 million new cases annually in the U.S.

Evofem Biosciences (OTCID: EVFM) reported improved financial results for Q2 2025, with net sales increasing 16% to $4.8 million compared to $4.2 million in Q2 2024. The company reduced its loss from operations to $1.3 million from $1.4 million year-over-year.

Key developments include advancing strategies to reduce manufacturing costs by 50% for PHEXXI and SOLOSEC, expanding into UAE markets, and progress in clinical trials. The company is proceeding with plans to become a wholly-owned subsidiary of Aditxt, having raised $2.4 million through senior subordinated notes and warrants in Q2 2025.

The company reported a net loss of $(0.02) per share compared to a net income of $0.02 per share in Q2 2024, with cash and equivalents of $0.7 million as of June 30, 2025.

Evofem Biosciences (OTCID: EVFM) announced that CEO Saundra Pelletier will receive the Trailblazing Female Founders Award at the 2025 STIMULATE Conference in Nashville. The recognition comes during Say Vagina Month, an initiative launched by Evofem to destigmatize vaginal health discussions.

The company highlighted clinical data showing that 90% of women using their hormone-free contraceptive PHEXXI® maintained or improved sexual satisfaction in the Phase 3 AMPOWER trial, as published in the Journal of Sexual Medicine. Evofem continues its mission of empowering women through science, advocacy, and access to healthcare.

Evofem Biosciences (NASDAQ:EVFM) has achieved significant social media success with its non-hormonal birth control brand PHEXXI through a viral TikTok campaign focused on microfeminism. The campaign, which generated over 10 million views and 24,000+ comments, sparked widespread media coverage from major outlets including BuzzFeed, MSN, and Scary Mommy.

The campaign's success aligns with PHEXXI's brand positioning as a hormone-free birth control option that emphasizes women's choice and autonomy. CEO Saundra Pelletier highlighted the brand's commitment to challenging norms in women's health, with plans for continued bold marketing initiatives in August.

Evofem Biosciences (OTCPK: EVFM) announced that Pharma 1 Drug Store has submitted PHEXXI, their FDA-approved hormone-free contraceptive, for marketing approval in the United Arab Emirates. Pharma 1 plans to place a launch quantity order in July 2025, with commercial launch targeted for Q1 2026. The Emirati healthcare company holds exclusive commercialization rights for PHEXXI in several Middle Eastern countries and will handle all aspects of distribution, sales, marketing, and regulatory compliance. PHEXXI is the first FDA-approved locally-acting contraceptive gel that works by maintaining vaginal pH levels inhospitable to sperm. Market research indicates growing demand for hormone-free contraception in the UAE region, suggesting strong potential for market acceptance.

Evofem Biosciences (OTCPK: EVFM) presented promising study results for SOLOSEC (secnidazole) in treating recurrent bacterial vaginosis (BV) at the 2025 ACOG Annual Meeting. The clinical study of 24 women showed that once-weekly dosing of SOLOSEC 2g oral granules demonstrated efficacy comparable or potentially superior to current CDC-recommended suppressive treatments. BV affects approximately 21 million U.S. women, with up to 50% experiencing recurrence within six months of treatment. The BV treatment market is projected to reach $1.0 billion in the U.S. by 2033. While SOLOSEC is currently approved for BV treatment in women aged 12 and older, its use in recurrent BV remains investigational. The simplified once-weekly oral dosing regimen could potentially improve treatment adherence compared to more complex existing protocols.

Evofem Biosciences (OTCPK: EVFM) has signed a License and Supply Agreement with Emirati healthcare company Pharma 1 for Middle East rights to SOLOSEC, an FDA-approved single-dose oral treatment for bacterial vaginosis (BV) and trichomoniasis. The deal includes an upfront payment, regulatory milestone payments, and sales-based milestones. Pharma 1 plans to submit for UAE regulatory approval in mid-2025. The agreement covers UAE, Kuwait, Saudi Arabia, Qatar, and other regional countries. Market potential is significant, with BV affecting 25-41% of women in the MENA region (1.0-1.7 million women in UAE alone), and trichomoniasis prevalence at 4.7% in the general female population. Pharma 1 will handle regulatory approvals, distribution, sales, marketing, and pharmacovigilance in the territory.

Evofem Biosciences (OTCPK: EVFM) reported Q1 2025 financial results with net sales of $0.8 million, down from $3.6 million in Q1 2024, primarily due to timing shifts in PHEXXI orders. The company achieved net income of $1.0 million ($0.01 per basic share), compared to a net loss of $4.9 million in Q1 2024. Total operating expenses decreased to $0.5 million from $6.4 million year-over-year. Key developments include a new manufacturing partnership with Windtree Therapeutics expected to reduce PHEXXI production costs by 55-60%, and strengthened IP protection for SOLOSEC extending to 2040. The company's cash position was $1.1 million as of March 31, 2025, with an additional $1.5 million raised in April through senior subordinated notes and warrants sale to Aditxt.

Evofem Biosciences (OTCQB: EVFM) has announced its upcoming participation in the Emerging Growth Conference on Thursday, April 17, 2025. The company's management team will deliver a presentation from 10:50 – 11:20 am ET (7:50 – 8:20 am PT).

The event will feature a live webcast accessible through the company's investor relations website. Following the presentation, there will be a Q&A session open to attendees. Investors, analysts, and investment advisors are encouraged to register early and submit questions in advance to Questions@EmergingGrowth.com.

The presentation will be available for viewing both live and as an archived recording through EmergingGrowth.com and the Emerging Growth YouTube Channel. Once available, an archive link will be added to Evofem's investor relations website.