EVOFEM BIOSCIENCE INC - EVFM STOCK NEWS

Evofem Biosciences, Inc. (Nasdaq: EVFM) has received approval from the Nasdaq Hearings Panel to continue its listing while awaiting shareholder vote on a proposed reverse stock split. This vote is scheduled for May 4, 2022. The proposed split ratio ranges from 1-for-5 to 1-for-15 shares. This action aims to ensure compliance with Nasdaq's minimum bid price requirement of $1.00 per share, as the company received a deficiency letter in August 2021. The company must regain compliance by May 20, 2022, or risk delisting.

Evofem Biosciences (Nasdaq: EVFM) announced significant findings from the Phase 2B/3 AMPREVENCE clinical trial, showcasing a 50% reduction in chlamydia and a 78% reduction in gonorrhea among women using EVO100 (investigational name for Phexxi). The trial involved 860 females aged 18-45 with prior infections. Additionally, patient satisfaction data were collected, contributing to the ongoing EVOGUARD Phase 3 trial, with topline results expected in late 2022. These findings aim to enhance access for EVO100 if approved.

Evofem Biosciences has completed enrollment in the EVOGUARD Phase 3 clinical trial for EVO100 (Phexxi) targeting prevention of chlamydia and gonorrhea among women. The trial exceeded its initial enrollment goal, reaching 1,903 participants, allowing for robust data collection. Top-line results are anticipated in late 2022. The FDA's QIDP designation for EVO100 may provide five additional years of exclusivity, and there is a noted need for new preventive options in light of rising infection rates. The complete trial outcome could significantly influence women's sexual health.

Evofem Biosciences, Inc. (Nasdaq: EVFM) reported strong growth for Q4 2021, with net product sales rising 109% to $3.6 million, largely due to a 73% increase in Phexxi units shipped. The company reduced its cash burn rate to $16.8 million from $32.0 million in Q3. Evofem also completed enrollment in its Phase 3 clinical trial for Phexxi, targeting new indications against chlamydia and gonorrhea, expecting to submit data to the FDA in early 2023. The total operating expenses for Q4 were $41.0 million, down from $45.1 million in Q3.

Evofem Biosciences, Inc. (NASDAQ: EVFM) will host a webcast and conference call on March 3, 2022, at 4:30 p.m. ET to discuss its financial results and business highlights for Q4 and the year ended December 31, 2021. Interested parties can access the live and archived webcast through the company's investor room. The conference call can be joined via phone, with a replay available for 24 hours post-call. Evofem is focused on developing innovative women's sexual and reproductive health products, including the FDA-approved contraceptive gel, Phexxi®.

Evofem Biosciences (NASDAQ: EVFM) announced FDA's "Qualified Infectious Disease Product" (QIDP) designation for EVO100, aimed at preventing urogenital chlamydia in women, marking a potential new indication in clinical development. The company is preparing for top-line data from the Phase 3 EVOGUARD trial in Q3 2022, with positive results likely supporting FDA submission early in 2023. The QIDP designation grants five additional years of marketing exclusivity upon approval, catering to the significant unmet need for STI prevention as no FDA-approved products currently exist.

Evofem Biosciences (NASDAQ: EVFM) will present at the Aegis Virtual Conference on February 23, 2022, at 4:30 p.m. ET. The webcast can be accessed via this link or on Zoom. Evofem is known for its innovative products in women's sexual and reproductive health, including Phexxi®, a hormone-free contraceptive vaginal gel. Phexxi® aims to address unmet needs in contraception and protection against STIs.

Evofem Biosciences (NASDAQ: EVFM) reported strong preliminary results for Q4 2021, achieving $3.5 million in net product sales, more than double Q3 sales. Key metrics included an 81% increase in dispensed Phexxi boxes and a 69% rise in total prescriptions filled. The company also reduced its net cash burn from $32 million in Q3 to approximately $17 million. Additionally, Evofem raised $5 million in non-dilutive capital in January 2022 to support ongoing initiatives. The CEO highlighted strong demand for Phexxi, projecting positive impacts from recently issued government guidance.

Evofem Biosciences (NASDAQ: EVFM) applauds recent guidance from HRSA and the U.S. Department of Labor, mandating coverage for FDA-approved contraceptives, including its product Phexxi, with no out-of-pocket costs for women. This guidance aims to enhance access to contraceptives under the Affordable Care Act, potentially benefiting millions of women. CEO Saundra Pelletier emphasized the positive impact on reducing unintended pregnancies and improving women's access to hormone-free birth control. The comprehensive coverage includes all FDA-approved contraceptives deemed medically necessary by healthcare providers.