Evofem Biosciences Inc - EVFM stock

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About

Evofem Biosciences, Inc. is a biopharmaceutical company based in San Diego, California, focused on developing and commercializing products to meet unmet needs in women's sexual and reproductive health, including Phexxi, a vaginal gel for pregnancy prevention, EVO100 for preventing chlamydia and gonorrhea, and EVO200 for recurrent bacterial vaginosis prevention.

Aditxt

Aditxt attempted to purchase Evofem in a deal valued at around $100 million, and both companies' boards gave their unanimous approval for this agreement. Under the terms of the acquisition, Aditxt will take on Evofem's senior secured debt and provide $18 million to Evofem's senior debtholder. Common stockholders of Evofem will exchange their shares for a total of 610,000 shares of Aditxt's common stock. Additionally, 89,126 shares of Aditxt preferred stock will be issued to Evofem investors who have outstanding loans and debts. Following the acquisition, Evofem will become a fully-owned subsidiary of Aditxt, and Saundra Pelletier will continue to serve as its CEO. In October, 2024, Evofem received a $2.28 million investment from Aditxt, Inc. from the purchase of Series F-1 convertible preferred stock. This marks the final equity investment required under the Amended and Restated Merger Agreement as part of Aditxt’s planned acquisition of Evofem.

History

Evofem Biosciences, Inc. has its origins in a merger between two biopharmaceutical companies: Neothetics, Inc. and Evofem, Inc. The merger took place in June 2018, resulting in the formation of the new entity, Evofem Biosciences, Inc.

Neothetics, Inc. was originally founded in 2007 in San Diego, California, with a focus on developing non-surgical aesthetic products for the treatment of localized fat deposits. The company's research efforts centered on developing injectable drugs to reduce subcutaneous fat, but their lead product candidate, LIPO-202, did not meet its primary endpoints in clinical trials, leading to a shift in the company's focus.

Evofem, Inc., on the other hand, was founded in 2007 under the name Instead Technologies, LLC, with the goal of developing and commercializing products in women's health. The company changed its name to Evofem Biosciences, Inc. in 2015. Evofem Biosciences focused on developing products to address unmet needs in women's sexual and reproductive health, including innovative contraceptive and prevention options.

The decision to merge Neothetics and Evofem, Inc. was aimed at leveraging their respective expertise and resources to create a stronger and more diversified biopharmaceutical company. The newly formed Evofem Biosciences, Inc. combined Neothetics' corporate structure and listing on the Nasdaq stock exchange with Evofem, Inc.'s portfolio of women's health products and research.

Following the merger, Evofem Biosciences continued to advance its product candidates, with a particular focus on Phexxi, a non-hormonal vaginal gel for pregnancy prevention, which received approval from the U.S. Food and Drug Administration (FDA) in May 2020.

Products

Phexxi

Phexxi is a hormone-free, on-demand prescription contraceptive vaginal gel developed. This FDA-approved product is designed to prevent pregnancy by maintaining vaginal pH within its normal acidic range of 3.5 to 4.5, creating an environment inhospitable to sperm. The gel is applied 0-60 minutes before intercourse using pre-filled applicators, offering women a non-hormonal birth control option that aligns with their lifestyle without requiring daily use or invasive procedures. The company claims that it is 86% effective with typical use and 93% effective when used as directed, based on clinical trial data.

Solosec

Solosec (secnidazole), is a prescription medication designed to treat bacterial vaginosis (BV) and trichomoniasis in patients 12 years and older. The company claims this product is the only single-dose oral antibiotic that provides a complete course of treatment for both BV, a common vaginal infection caused by an overgrowth of bacteria, and trichomoniasis, a sexually transmitted infection (STI) caused by the parasite Trichomonas vaginalis. It is taken by sprinkling a 2-gram packet of granules onto soft foods like applesauce, yogurt, or pudding, and consumed within 30 minutes without chewing the granules. Solosec is a 5-nitroimidazole antimicrobial that works by disrupting the DNA of harmful bacteria or parasites, effectively stopping their growth. This single-dose approach contrasts with multi-day treatments, offering convenience and potentially improving patient adherence. Clinical trials show efficacy for BV of up to 53.3%. For trichomoniasis, a trial showed a 92.2% microbiological cure rate compared to placebo, based on a test of cure 6-12 days post-dose.

Patents

Phexxi

The USPTO has issued a Notice of Allowance for a patent application covering methods of contraception using the composition in Phexxi® vaginal gel. Once issued, this will be Evofem's fifth U.S. patent for Phexxi and will be Orange Book-listable. Phexxi is an FDA-approved, hormone-free contraceptive gel applied before intercourse.

SOLOSEC

Evofem holds a U.S. patent for SOLOSEC® with a Notice of Allowance from the USPTO, reinforcing its intellectual property for treating and preventing trichomoniasis.