Evofem Bioscienc Stock Price, News & Analysis

Evofem Biosciences, Inc. (NASDAQ: EVFM) has commenced the pivotal Phase 3 EVOGUARD trial, enrolling its first patient to assess the efficacy and safety of EVO100 in preventing urogenital chlamydia and gonorrhea in women. With rising infection rates and increasing antibiotic resistance, the need for preventive measures like EVO100 has become critical. The trial will involve 1,730 women at risk of these infections. The FDA has granted EVO100 Fast Track Designation for chlamydia prevention, and it has also received Qualified Infectious Disease Product designation for gonorrhea.

Evofem Biosciences (NASDAQ: EVFM) has secured $25 million from the sale of unsecured convertible promissory notes to Adjuvant Capital. The notes, convertible at a price of $3.65 per share, will fund the upcoming Phase 3 clinical trial, EVOGUARD, for its product EVO100 targeting urogenital chlamydia and gonorrhea prevention in women. The company aims to expand market access for its non-hormonal contraceptive, Phexxi™, approved in May 2020. This partnership aligns with Adjuvant's mission to enhance contraceptive access globally.

Evofem Biosciences (NASDAQ: EVFM) announced new clinical trial data on Phexxi™ and EVO100 to be presented at major medical society meetings this October. The data includes insights into Phexxi users and factors affecting reinfection rates of chlamydia and gonorrhea, as well as findings related to the sexual impact of treatment. The AMPREVENCE trial enrolled 860 women, while the AMPOWER trial involved 1,384 participants, evaluating Phexxi's contraceptive efficacy. The company continues its publication strategy with nine abstracts to be presented this fall.

Evofem Biosciences, Inc. (NASDAQ: EVFM) announced a rescheduled virtual fireside chat at the 2020 Cantor Global Virtual Healthcare Conference, set for September 17, 2020, from 1:20 p.m. to 1:50 p.m. ET. Interested parties can access the live and archived webcast on Evofem's website under the Investors section. The company focuses on developing innovative products in women's sexual and reproductive health, including its first product, Phexxi™, a hormone-free contraceptive gel. The firm is also advancing EVO100 into a Phase 3 clinical trial for STI prevention.

Evofem Biosciences (NASDAQ: EVFM) announced positive results from its Phase 2b AMPREVENCE trial at the 2020 STD Prevention Virtual Conference. The trial evaluated EVO100 for preventing urogenital chlamydia and gonorrhea in women, achieving a 50% risk reduction for chlamydia and 78% for gonorrhea compared to placebo. The product was well tolerated by participants. Following this success and a favorable FDA data review, Evofem plans to initiate a Phase 3 trial in Q4 2020, demonstrating the potential impact of EVO100 on women's health amid rising STI rates in the U.S.

Evofem Biosciences (NASDAQ: EVFM) announced the U.S. launch of Phexxi™, the first non-hormonal prescription vaginal gel for on-demand contraception. Approved by the FDA on May 22, 2020, Phexxi maintains vaginal pH to prevent sperm viability. The product will be marketed in boxes of 12 applicators. Evofem also introduced the Phexxi Concierge Experience, a telemedicine support system for prescription access and counseling. Financial assistance will allow eligible women to purchase Phexxi with low co-pays. Notably, Phexxi does not prevent STIs and may have side effects.

Evofem Biosciences (NASDAQ: EVFM) announced its participation in four healthcare equity conferences in September 2020. The events include:

• H.C. Wainwright & Co. 22nd Annual Global Investment Conference on September 14
• 2020 Cantor Global Virtual Healthcare Conference on September 16
• Morgan Stanley 18th Annual Global Healthcare Conference on September 18
• Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 22

Evofem Biosciences (NASDAQ: EVFM) announced on August 18, 2020, that its Compensation Committee approved stock option awards for 60 new employees, totaling 319,200 shares of common stock. The options have an exercise price of $3.35 and a 10-year term, vesting over four years. This grant aligns with the company's 2018 Inducement Equity Incentive Plan intended to attract new talent. Evofem focuses on developing products for women's sexual and reproductive health, with its leading product, Phexxi™, being the first hormone-free contraceptive gel approved in the U.S.

Evofem Biosciences (NASDAQ: EVFM) reported its Q2 2020 financial results, highlighting the FDA approval of Phexxi, a contraceptive, and raising over $130 million in gross proceeds from financing. The company is set for Phexxi's commercial launch in September. Key highlights included a net loss of $52.7 million, or $(0.91) per share, compared to $(0.97) per share in Q2 2019, while unrestricted cash stood at $123.6 million. Guidance for 2020 remains unchanged, projecting sales and marketing expenses of $63 to $68 million and cash burn of $36 to $44 million in Q4.