Evofem, Inc.

MOUNTAIN VIEW, Calif.--( BUSINESS WIRE )--Aditxt, Inc. (“Aditxt”) (NASDAQ: ADTX), a company dedicated to discovering, developing, and deploying promising health innovations, announces this past Friday, July 12 th , Aditxt, its wholly owned subsidiary Adifem, Inc., and Evofem Biosciences, Inc.’s (“Evofem”) (OTCQB: EVFM) amended and restated their Merger Agreement. This amended and restated Merger Agreement, among others, addresses pre-closing issues critical for Evofem’s future success, including interim financing needs. The other revisions to the Merger Agreement, alongside additional interim financing for Evofem, include substituting cash for Aditxt’s common stock as the consideration for Evofem’s common stock in the merger and additional changes relating to it. Aditxt and Evofem are diligently working to close the contemplated transaction in the second half of 2024. The closing of the transaction between Aditxt and Evofem remains subject to the successful satisfaction of a number of closing conditions, including, but not limited to, Aditxt securing sufficient financing to fund its obligations at closing. No assurance can be given that all of the conditions to closing will be obtained or satisfied or that the transaction will ultimately close. Evofem recently announced the acquisition of SOLOSEC ® (secnidazole) 2g oral granules from Lupin Limited. Under the transaction terms, Lupin can receive a potential total consideration of up to $84 million based on future contingent milestones. “Aditxt and Evofem share a common vision in recognizing and valuing innovations like SOLOSEC that need additional support to reach their full potential,” said Saundra Pelletier, Chief Executive Officer of Evofem. “The expertise, focus, and tenacity of Evofem's U.S. commercial organization have enabled us to deliver consistent annual net sales growth for Phexxi since its launch. With the addition of Aditxt's platform, we believe can accelerate our growth trajectory and expand into a multi-product women's health franchise. We are excited to harness these strengths and leverage our physician relationships to re-launch and grow SOLOSEC, which offers an attractive ‘one-and-done’ oral dosing regimen for women with bacterial vaginosis and trichomoniasis.” Amro Albanna, Co-Founder, Chairman, and CEO of Aditxt, commented on this announcement, “The acquisition of SOLOSEC marks an important milestone in Evofem’s evolution. We believe that SOLOSEC is a valuable asset that diversifies Evofem’s portfolio and has the potential to accelerate its evolution into a dynamic global women’s health business that addresses significant health challenges. Our commitment to supporting the expansion of Evofem’s portfolio with additional products and broadening its market reach domestically and internationally exemplifies how the Aditxt model operates. Our confidence in Evofem’s potential has only strengthened, and we firmly believe that, if supported by the right resources, they will drive significant advancements in women’s health.” About Aditxt, Inc. Aditxt, Inc.® (“Aditxt”) (NASDAQ: ADTX) is a social innovation platform dedicated to discovering, developing, and deploying promising innovations. Aditxt’s ecosystem of research institutions, industry partners, and shareholders collaboratively drives their mission to “Make Promising Innovations Possible Together.” The social innovation platform is the cornerstone of Aditxt’s strategy, where multiple disciplines drive disruptive growth and address significant societal challenges. Aditxt operates a unique model democratizing innovation, ensuring every stakeholder’s voice is heard and valued, empowering collective progress. Aditxt has a diverse innovation portfolio, including Adimune™, Inc., which is leading the charge in developing a novel class of therapeutics for retraining the immune system to combat organ rejection, autoimmunity, and allergies. Adivir™, Inc. focuses on enhancing population health, impacting public health globally, and Pearsanta™, Inc. delivers rapid, personalized, and high-quality lab testing accessible anytime, anywhere, at their CLIA-certified and CAP-accredited clinical laboratory based in Richmond, VA. For more information see: www.aditxt.com About SOLOSEC ® SOLOSEC ® (secnidazole) 2 g oral granules is the first and only single-dose oral prescription approved to treat both bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age, and trichomoniasis, a sexually transmitted infection, in people 12 years of age and older. Since trichomoniasis is a sexually transmitted infection, sexual partners of infected patients should be treated with the same dose and at the same time to prevent reinfection. SOLOSEC is designed to be easy to take, and one oral dose contains a complete course of treatment. 1 Additional information about SOLOSEC® can be found at www.SOLOSEC.com . 1 SOLOSEC Package Insert Forward-Looking Statements Certain statements in this press release constitute “forward-looking statements” within the meaning of federal securities laws. Forward-looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the Company’s ongoing and planned product and business development; the Company’s ability to finance and execute on its strategic M&A initiatives; the Company’s ability obtain the necessary funding and partner to commence clinical trials; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the Company’s ability to raise additional capital; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as market and other conditions and those risks more fully discussed in the section titled “Risk Factors” in the Company’s most recent Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s other filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

MUMBAI, India and NAPLES, Fla. and SAN DIEGO, July 15, 2024 /PRNewswire/ -- Global pharma major Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) announced today that it has divested its U.S. Commercial Women's Health Specialty Business to Evofem Biosciences, Inc. (OTCQB: EVFM) (Evofem), a U.S. biopharmaceutical company focused exclusively on Women's Health. Lupin's U.S. Commercial Women's Health Specialty Business is primarily focused on commercializing SOLOSEC® (secnidazole) 2g oral granules. This FDA-approved single-dose antimicrobial agent provides a complete course of therapy for the treatment of bacterial vaginosis (BV) and trichomoniasis, two common sexual health infections. Continue Reading Lupin Divests U.S. Commercial Women's Health Specialty Business to Evofem, including SOLOSEC Under the terms of the deal, Lupin can receive a potential total consideration of up to USD 84 million based on future contingent milestones. Dr. Fabrice Egros, President - Global Corporate Development, Lupin, said, "We are very pleased to divest our U.S. Commercial Women's Health Specialty business, including SOLOSEC®, to Evofem. This divestment is another step in aligning our U.S. specialty business with our strategic plan to build our specialty business in therapeutic areas where we have building blocks of synergy. These include respiratory and neurological diseases." "The acquisition of this commercial business aligns with and advances our mission to improve access to innovative and differentiated options that impact women's daily lives. SOLOSEC is a commercially attractive, single-dose oral antibiotic that addresses two pervasive sexual health infections. We can now fully leverage our commercial infrastructure, maximize our strong physician relationships, and re-launch an asset with tremendous growth potential," said Saundra Pelletier, Chief Executive Officer, Evofem. About Lupin Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women's health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.8% of its revenue in research and development in FY24. Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a 'Great Place to Work' in the Biotechnology & Pharmaceuticals sector. Please visit for more information. Follow us on: LinkedIn: Facebook: X (f/k/a Twitter): About Evofem Biosciences Evofem Biosciences is focused on commercializing innovative products to address unmet needs in women's sexual and reproductive health. The Company's first FDA-approved product, Phexxi® (lactic acid, citric acid, and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex. Learn more at phexxi.com and evofem.com. In December 2023, Evofem entered into a Merger Agreement with Aditxt, Inc. (Nasdaq: ADTX) under which Aditxt intends to acquire Evofem. The parties reinstated and amended the Merger Agreement, as amended, in May 2024 and are working to close the contemplated transaction in the second half of 2024. Follow us on: LinkedIn: Facebook: X (f/k/a Twitter): About SOLOSEC® SOLOSEC® (secnidazole) 2 g oral granules is the first and only single-dose oral prescription approved to treat both bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and trichomoniasis, a sexually transmitted infection, in people 12 years of age and older.1-4 Since trichomoniasis is a sexually transmitted infection, sexual partners of infected patients should be treated with the same dose and at the same time to prevent reinfection. SOLOSEC® is designed to be easy to take and one oral dose contains a complete course of treatment.[1] Additional information about SOLOSEC® can be found at . References: 1 SOLOSEC Package Insert 2 Workowski KA, Bachmann LH, Chan PA, et al. CDC Sexually Transmitted Diseases Treatment Guidelines, 2001. MMWR Recomm Rep 2021; 70(RR-04):1-192. 3 Onderdonk AB, Delaney ML, Fichorova RN. The Human Microbiome During Bacterial Vaginosis. Clin Microbiol Rev. 2016;29(2):223-238. 4 Koumans EH, Sternberg M, Bruce C, et al. The prevalence of bacterial vaginosis in the United States, 2001-2004; associations with symptoms, sexual behaviors, and reproductive health. Sex Transm Dis. 2007;34(11):864-869. Forward-Looking Statements This press release includes "forward-looking statements," within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 including, without limitation, statements regarding the anticipated timing to close the contemplated Aditxt transaction. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in Evofem's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 27, 2024, Quarterly Report on Form 10-Q for the three months ended March 31, 2024 filed with the SEC on May 12, 2024, and any subsequent filings. All forward-looking statements are expressly qualified in their entirety by such factors. Evofem does not undertake any duty to update any forward-looking statement except as required by law. Photo: Logo: SOURCE Lupin Limited

Lupin Limited announced it has divested its U.S. Commercial Women's Health Specialty Business to Evofem Biosciences. The business primarily focuses on Solosec (secnidazole) 2g oral granules, an FDA-approved single-dose antimicrobial for treating bacterial vaginosis and trichomoniasis. Under the terms of the deal, Lupin could earn up to $84 million based on future performance milestones. The move is part of Lupin's strategy to focus its U.S. specialty business on respiratory and neurological diseases, the company said. Evofem plans to enhance its commercial infrastructure with an aim to relaunch Solosec. In December of 2023, Aditxt acquired Evofem for approximately $100 million, incorporating Evofem's contraceptive gel, Phexxi, into its portfolio. The transaction is expected to close this year. Evofem's Phexxi, the first FDA-approved hormone-free contraceptive gel, faced FDA criticism for misleading efficacy claims . Evofem responded with cost-cutting measures and a strategic focus on Phexxi.