Evofem Bioscienc Stock Price, News & Analysis

Evofem Biosciences, Inc. (OTCQB: EVFM) has announced that the Phase 3 EVOGUARD clinical trial for its product EVO100, aimed at preventing chlamydia and gonorrhea infections in women, did not meet its endpoints. Despite a consistent safety profile, the trial's failure has raised concerns, with executives attributing the results partially to COVID-19 impacts on trial conditions. The company will redirect focus toward its FDA-approved product, Phexxi, which has shown strong sales growth and market access expansion. Future investment in the STI program will be discontinued due to financial constraints.

On October 6, 2022, Evofem Biosciences (OTCQB: EVFM) announced its hormone-free contraceptive gel received regulatory approval from Nigeria's NAFDAC. This marks the company's first approval outside the U.S., with plans for additional submissions in Ghana, Ethiopia, and Mexico. The product may be marketed as Femidence™, targeting Nigeria's 45 million women of reproductive age. In October 2020, Adjuvant Capital invested $25 million to support global market access for Phexxi and ongoing clinical trials to evaluate its effectiveness against chlamydia and gonorrhea, with results expected in mid-October 2022.

Evofem Biosciences (OTCQB: EVFM) has upgraded its trading status to the OTCQB Venture Market from the OTC Pink Open Market, retaining its ticker symbol. The company's product, Phexxi®, a hormone-free contraceptive vaginal gel, has seen increasing net sales for three consecutive quarters. The upcoming third-quarter results are expected to continue this upward trend. Scheduled for mid-October 2022, the Phase 3 clinical trial data on Phexxi's effectiveness against chlamydia and gonorrhea could lead to regulatory submissions in 2023, marking a significant step in women's health.

Evofem Biosciences announced the issuance of U.S. Patent No. 11,439,610 covering Phexxi, its hormone-free contraceptive gel. This patent, expected to protect Phexxi until at least 2033, enhances the company's intellectual property portfolio, which includes over 40 patents. Since its launch in 2020, Phexxi has been prescribed to over 100,000 women. Top-line data from the Phase 3 EVOGUARD trial, evaluating Phexxi for preventing chlamydia and gonorrhea, is anticipated in mid-October 2022, with potential regulatory submissions in 2023.

Evofem Biosciences congratulates Dr. Donald Waller, Professor Emeritus at UIC, for being named Inventor of the Year for his contributions to women’s health, particularly for the development of Phexxi, an innovative contraceptive. Since its FDA approval in 2020, over 100,000 prescriptions have been issued. The company anticipates top-line results in October from a Phase 3 clinical trial evaluating Phexxi for preventing chlamydia and gonorrhea, with potential regulatory submissions in 2023. Growing cases of STIs underscore the importance of such innovations.

Evofem Biosciences, Inc. (OTCPK: EVFM) announced a significant insurance victory, expanding access to its hormone-free contraceptive, Phexxi, to millions of women across the U.S. This new inclusion by a major national payer adds nearly four million covered lives. The approval rate for Phexxi claims reached over 72% in July 2022. The company continues its efforts to ensure compliance with recent federal guidelines mandating contraceptive coverage at no cost to patients. Evofem is also poised to report pivotal trial data in October 2022 for new indications of Phexxi.

Evofem Biosciences announced on September 16, 2022, a successful debt restructuring, securing forbearance from debtholders regarding existing defaults. This arrangement alleviates pressure from a previous Nasdaq delisting and emphasizes the importance of its contraceptive product, Phexxi. Key aspects include junior unsecured debt holders converting their obligations into stock rights and a healthcare investor accepting payment-in-kind for future interest. Positive clinical trial results expected next month could enhance strategic discussions and regulatory submissions for Phexxi's expanded use.

Evofem Biosciences (EVFM) will conduct an investor call on Thursday, August 11, 2022, at 5:00 p.m. ET. The call will focus on the company's developments in women's sexual and reproductive health, particularly regarding their FDA-approved product, Phexxi®. Phexxi is a hormone-free vaginal gel contraceptive. The company anticipates releasing top-line data in October 2022 from its Phase 3 EVOGUARD clinical trial, which studies Phexxi for preventing chlamydia and gonorrhea. Details for joining the call are available in the press release.

Evofem Biosciences (Nasdaq: EVFM) reported a strong second quarter of 2022, with Phexxi net product sales rising 42% quarter-over-quarter to $6.0 million. Operating expenses decreased by 8% to $30.5 million, which improved the loss from operations by 16% to $24.4 million. The company completed a Phase 3 trial for Phexxi to prevent chlamydia and gonorrhea, with top-line data expected in October 2022. Evofem maintains its 2022 guidance with expected net sales of $30 to $35 million, reflecting significant growth potential.