Aditxt is set to acquire women's health startup Evofem Biosciences, in a transaction valued at approximately $100 million.
The acquisition, which involves the issuance of common and preferred stock, will integrate Evofem's product, Phexxi, into Virginia-based Aditxt's health innovations portfolio, marking the establishment of a women's health mission.
Evofem, known for its work in reproductive health care, developed Phexxi, the first FDA-approved hormone-free contraceptive gel. The gel was launched in 2020, but recently ran into criticism from the FDA, who alleged misleading promotional claims regarding the gel's efficacy in preventing pregnancy. The FDA pointed out that the brochure's emphasis on a 99% pregnancy prevention rate relies on an unvalidated measure, assuming a consistent likelihood of pregnancy throughout the menstrual cycle.
The FDA argued that this method results in an overestimation of the gel's contraceptive effect, urging Evofem to adopt validated endpoints, such as the Kaplan-Meier life-table analysis and the Pearl Index, for a more precise assessment of cumulative failure rates over specific exposure durations.
A few weeks later, the drugmaker announced it would be implementing cost-cutting measures to achieve cash flow neutrality by year-end. The measures included a reduction in the CEO's salary, emphasizing a strategic focus on advancing Phexxi.
Pending regulatory approval, the transaction with Aditxt is expected to close in the first half of 2024.