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Aditxt Inc (ADTX) is a pioneering biotechnology company developing innovative solutions to reprogram immune responses, with applications in organ transplantation and autoimmune disorders. This dedicated news hub provides investors and researchers with timely updates on clinical advancements, regulatory milestones, and strategic partnerships.
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Bookmark this page for consolidated access to press releases, clinical trial data disclosures, and expert analyses of ADTX's position in the competitive immunotherapy landscape. Stay informed about technological breakthroughs through verified updates from primary sources.
Evofem Biosciences (OTCQB: EVFM) is addressing concerns about the impact of GLP-1 receptor agonists on oral contraceptive effectiveness. These medications, used for obesity and type 2 diabetes treatment, can cause gastrointestinal side effects that may reduce oral contraceptive absorption. Evofem offers Phexxi, a hormone-free, on-demand contraceptive gel, as a non-oral alternative.
Phexxi maintains the vagina's acidic pH, creating an environment inhospitable to sperm. It's particularly suitable for women using GLP-1 medications who are concerned about potential drug interactions affecting their birth control efficacy. Evofem's CEO, Saundra Pelletier, emphasizes the importance of understanding these interactions and providing alternative contraceptive options for women managing chronic conditions like obesity and diabetes.
Evofem Biosciences reported financial results for Q2 2024, showing significant improvements:
- Net product sales increased 69% to $4.2 million
- Operating loss improved 81% to $1.4 million
- Total operating expenses decreased 43% to $5.5 million
Key developments include:
- Acquisition of global rights to SOLOSEC, a single-dose antibiotic for sexual health infections
- Licensing of Phexxi commercial rights in the Middle East
- Partnership with Hello Alpha to offer Phexxi as hormone-free contraception
- 7.4% lower rebate on Phexxi prescriptions to Medi-Cal
- Issuance of fifth U.S. patent for Phexxi
The company received $2.0 million from Aditxt, Inc. to reinstate the Merger Agreement and through preferred stock sale.
Aditxt (NASDAQ: ADTX) announced the successful passage of all nine proposals at its recent annual shareholders' meeting, setting the stage for its 2024 and 2025 strategic plans. Key approvals include:
1. Election of directors
2. Ratification of auditors
3. Issuance of shares for Series B-1 and B-2 Convertible Preferred Stock
4. Equity Line of Credit (ELOC) proposal for up to $150 million
5. Increase in authorized shares from 100 million to 1 billion
6. Reverse stock split authority (1:5 to 1:200)
7. Amendment to the 2021 Omnibus Equity Incentive Plan
These approvals provide Aditxt with flexibility and potential resources to advance its strategic initiatives in immune health, precision health, public health, and women's health programs.
Aditxt, Inc. (NASDAQ: ADTX) has closed a $1.2 million registered direct offering priced at-the-market under Nasdaq rules. The offering involved the sale of 1,130,189 shares of common stock (or equivalents) at $1.06 per share. H.C. Wainwright & Co. acted as the exclusive placement agent. Aditxt plans to use $500,000 of the net proceeds to fund obligations under its Amended and Restated Merger Agreement with Evofem Biosciences, Inc., with the remainder allocated for working capital and general corporate purposes. The offering was made pursuant to a shelf registration statement on Form S-3 filed with the SEC.
Aditxt (NASDAQ: ADTX) has announced a $1.2 million registered direct offering priced at-the-market under Nasdaq rules. The company will sell 1,130,189 shares of common stock (or equivalents) at $1.06 per share to institutional investors. The offering is expected to close around August 9, 2024. H.C. Wainwright & Co. is the exclusive placement agent. Aditxt plans to use $500,000 of the net proceeds to fund obligations under its merger agreement with Evofem Biosciences, with the remainder for working capital and general corporate purposes. The offering is made pursuant to a shelf registration statement on Form S-3 filed with the SEC.
Aditxt (NASDAQ: ADTX) announced that its subsidiary, Pearsanta, has submitted a proposal for the Clinical Trial Translational Endpoints Research Award to validate a novel assay for early detection of ovarian cancer. The proposal aims to validate the Mitomic Ovarian Test (MOT), which uses mitochondrial DNA mutations as early indicators of ovarian cancer. The study will enroll 100 subjects with ovarian cancer and 200 negative controls, aiming to detect significant diagnostic accuracy (AUC > 0.85) at each stage of epithelial ovarian cancer vs. controls.
The ovarian cancer diagnostic market is projected to grow from $1.5 billion in 2023 to $2.7 billion by 2032. Currently, no blood tests are available with adequate sensitivity for early ovarian cancer detection. If successful, Pearsanta's MOT could significantly improve survival rates for women with ovarian cancer through earlier detection and more effective treatment interventions.
Aditxt (NASDAQ: ADTX) has signed a second amendment to the arrangement agreement with Appili Therapeutics, targeting a September 30, 2024 closing date for the acquisition. The deal involves Aditxt acquiring all issued and outstanding Class A common shares of Appili through a court-approved plan. Key conditions include Aditxt raising at least US$20 million in financing before closing.
Appili has raised over CAD $100 million since 2015 for developing therapeutics in the global infectious disease and biodefense markets. Their portfolio includes LIKMEZ™, an FDA-approved antibiotic suspension, ATI-1701, a tularemia vaccine, and ATI-1801, a topical antiparasitic product. Two programs are potentially eligible for FDA Priority Review Vouchers, subject to legislation renewal.
Evofem Biosciences (OTCQB: EVFM) has signed a License and Supply Agreement with Pharma 1 Drug Store for the Middle East rights to Phexxi, its FDA-approved hormone-free contraceptive. Pharma 1 will have exclusive commercialization rights in several Middle Eastern countries, including the UAE, Kuwait, Saudi Arabia, and Qatar. The company plans to file for regulatory approval in the UAE in Q3 2024.
The UAE contraceptive drug market is projected to reach $185.1 million by 2030. This agreement aligns with Evofem's strategy to expand and diversify its revenue stream. Phexxi is the first and only locally-acting contraceptive gel approved by the FDA, applied before intercourse to maintain a vaginal pH inhospitable to sperm and certain pathogens.
Aditxt (NASDAQ: ADTX) and Evofem Biosciences (OTCQB: EVFM) have amended and restated their Merger Agreement, targeting a September 30 closing. Key changes include addressing Evofem's interim financing needs and substituting cash for Aditxt's common stock as merger consideration. Concurrently, Evofem acquired SOLOSEC, an FDA-approved single-dose treatment for bacterial vaginosis and trichomoniasis, from Lupin for up to $84 million in contingent milestones.
The acquisition diversifies Evofem's portfolio and aligns with Aditxt's vision of supporting promising health innovations. Both companies are working to close the transaction in the second half of 2024, subject to various conditions including Aditxt securing sufficient financing. The merger aims to accelerate Evofem's growth and expand its women's health franchise.
Lupin has divested its U.S. Commercial Women's Health Specialty Business to Evofem Biosciences, Inc. The deal includes the transfer of SOLOSEC®, an FDA-approved single-dose antimicrobial agent for treating bacterial vaginosis and trichomoniasis. Lupin could receive up to USD 84 million based on future contingent milestones.
This strategic move aligns with Lupin's plan to focus on therapeutic areas with synergistic potential, such as respiratory and neurological diseases. For Evofem, the acquisition enhances its women's health portfolio and leverages its existing commercial infrastructure.
