Evofem Bioscienc Stock Price, News & Analysis

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.

Evofem Biosciences (OTCQB: EVFM) has entered into a License and Supply Agreement with Windtree Therapeutics (NasdaqCM: WINT) to reduce manufacturing costs of PHEXXI, their FDA-approved hormone-free contraceptive vaginal gel. The partnership is expected to decrease PHEXXI's manufacturing costs by 55% to 60% from current levels, with no tech transfer costs to Evofem.

PHEXXI, which prevents pregnancy by maintaining normal vaginal pH levels inhospitable to sperm, will benefit from Windtree's manufacturing contacts to achieve lower production costs. This cost reduction aims to facilitate PHEXXI's global expansion into price-sensitive markets where non-hormonal contraceptives are in demand.

Evofem maintains ownership and continues U.S. commercialization through its sales team, while pursuing international expansion through strategic partnerships, including a July 2024 license agreement with Pharma 1 Drug Store for UAE market entry.

Evofem Biosciences (OTCQB: EVFM) reported its financial results for Q4 and full-year 2024, marking its fourth consecutive year of net sales growth. The company achieved $19.4 million in net sales for 2024, a 6% increase from 2023, primarily driven by PHEXXI® sales and improved gross-to-net ratio.

Key operational highlights include:

• Total operating expense reduced by 27% to $26.4 million (excluding SOLOSEC amortization)
• Sales and marketing expense at 47% of net sales for 2024, the best ratio since PHEXXI's launch
• Loss from operations improved by 57% to $7.7 million
• Revenue stream diversified through SOLOSEC® acquisition in July 2024

The company entered a fifth amendment to the merger agreement with Aditxt (NASDAQ: ADTX), requiring $1.5 million funding by April 7, 2025, and merger consummation by September 30, 2025. Additionally, Evofem partnered with Windtree Therapeutics to reduce PHEXXI manufacturing costs.

Evofem Biosciences (OTCQB: EVFM) has received a Notice of Allowance from the USPTO for a new patent application related to SOLOSEC®, extending its intellectual property protection until 2040. The patent covers the treatment of trichomoniasis with SOLOSEC® 2g oral granules, focusing on pharmacokinetics and formulation features.

SOLOSEC® is the first and only single-dose oral antibiotic FDA-approved for treating both bacterial vaginosis in females and trichomoniasis in people 12 years and older. The company acquired global rights to the product in July 2024 and relaunched it in the U.S. in November 2024.

The patent extension provides an additional five years of protection beyond the previous 2035 expiration. Trichomoniasis, affecting an estimated 6.9 million new cases annually in the U.S., is the most common non-viral sexually transmitted infection globally.

Evofem Biosciences (EVFM) reported Q3 2024 financial results, highlighting a 31% improvement in operating loss to $2.4 million compared to $3.6 million in Q3 2023. Net product sales decreased 12% to $4.5 million. The company acquired global rights to SOLOSEC, a single-dose oral antibiotic, and licensed Phexxi commercial rights in the Middle East. Total operating expenses decreased 20% to $6.9 million. Aditxt invested $5.0 million in Evofem since May 2024, including $1.3 million in Q3 and $2.7 million in October 2024.

Evofem Biosciences (OTCQB: EVFM) has secured voting agreements with Series E-1 stockholders and convertible noteholders to support its proposed merger with Aditxt's subsidiary Adifem. This follows Aditxt's recent $2.28 million investment in Evofem through Series F-1 convertible preferred stock, completing their total $5.0 million commitment since May 2024. The merger's closing conditions include majority shareholder approval and Aditxt raising approximately $17 million, with $15.2 million needed to satisfy Evofem's senior secured noteholder. The capital received has enabled Evofem to acquire SOLOSEC® and support Phexxi® initiatives targeting GLP-1 users.