Financial Performance - The company reported a net loss of $22,492,573 for the six months ended June 30, 2024, with cash reserves of $91,223 as of the same date, raising concerns about its ability to continue operations beyond one year [180]. - For the three months ended June 30, 2024, the company generated revenue of $44,276, a decrease of 80% compared to $220,978 for the same period in 2023 [182]. - The company incurred a loss from operations of $5,975,981 for the three months ended June 30, 2024, compared to a loss of $4,234,437 for the same period in 2023, reflecting an increase of 41% in operational losses [182]. - As of June 30, 2024, the company had an accumulated deficit of $150,024,555 and working capital of $(19,058,995) [184]. - The company expects to incur additional net expenses over the next several years as it continues to maintain and expand its operations, with future profitability remaining uncertain [181]. - The company raised approximately $9 million from a private placement that closed on September 6, 2023, which was used for outstanding obligations and working capital [184]. Research and Development - Adimune, Inc. is advancing its proprietary immune modulation product candidate, ADI-100, which has shown success in preclinical models for autoimmune diseases and is set to begin human trials for Stiff Person Syndrome in the first half of 2024 [164]. - Pearsanta, Inc. aims to revolutionize personalized medicine with a platform for lab-quality testing, targeting a clinical and consumer diagnostic market projected to reach $429.3 billion by 2030 [169]. - The Mitomic® Technology Platform, acquired from MDNA, focuses on non-invasive, blood-based liquid biopsies to detect diseases through mitochondrial DNA, enhancing early diagnosis and treatment [171]. - The Mitomic® Endometriosis Test (MET™) aims to provide accurate, non-invasive diagnosis of endometriosis, potentially reducing the diagnostic delay of around ten years [172]. - The Mitomic® Prostate Test (MPT™) seeks to improve detection of clinically significant prostate cancer, reducing reliance on PSA testing and avoiding unnecessary procedures [172]. - AditxtScore™ technology is being developed to provide a comprehensive profile of the immune system, with the potential to detect individual immune responses to various agents [173]. - The company has entered into a license agreement with Loma Linda University for the exclusive worldwide commercialization of ADI nucleic acid-based technology, which is currently in the preclinical stage [168]. - Adivir, Inc. is focused on developing innovative antiviral products to address a range of infectious diseases, collaborating with Appili to advance a diverse pipeline of anti-infectives [177]. Operational Challenges - The company is currently over 90 days past due on several vendor obligations and requires significant additional capital to fund clinical studies and normal operations [180]. - A fee of $1,000,000 was paid to Evofem as part of an amendment to a merger agreement, impacting general and administrative expenses significantly [182]. - The company will need significant additional capital to fund operations and clinical trials, with future financing dependent on market conditions [186]. Internal Controls and Compliance - The company is in the process of remediating material weaknesses in its internal controls over financial reporting [195]. - The company did not maintain adequate controls over the documentation of accounting and financial reporting policies, leading to material misstatements in financial statements [195]. - Material weaknesses identified include insufficient procedures for account reconciliations and the identification and cutoff of accounts payable [195]. - No changes occurred in internal control over financial reporting that materially affected the company's reporting during the quarter ended June 30, 2024 [196]. - The company is in the process of remediating identified material weaknesses in internal controls [195]. Legal Risks - The company may become involved in various lawsuits and legal proceedings, which could adversely affect its business [197].

Group 1 - Aditxt's stock is experiencing a significant rise due to an update on a clinical trial from its subsidiary Pearsanta, which submitted a proposal for a Clinical Trial Translational Endpoints Research Award to the Department of Defense [1] - The proposal aims to validate a novel assay based on Pearsanta's Mitomic Technology for the early detection of ovarian cancer, which is part of the company's mission to revolutionize early cancer detection [1] - Pearsanta's president emphasized the importance of this proposal in providing a reliable, non-invasive blood test that could lead to earlier detection and more effective treatments for cancer [1] Group 2 - The trading volume of Aditxt's stock has surged, with over 97 million shares changing hands, a significant increase from the daily average of approximately 615,000 shares [2] - As of Wednesday afternoon, Aditxt's stock price has increased by 48.8% [2]

Core Insights - Evofem Biosciences, Inc. is focused on women's sexual and reproductive health, with recent developments including the acquisition of SOLOSEC® and licensing of Phexxi® in the Middle East [2][3][4] Company Highlights - The company acquired global rights to SOLOSEC® (secnidazole) 2 g oral granules, a single-dose oral antibiotic for treating bacterial vaginosis and trichomoniasis [2][3] - Evofem licensed commercial rights to hormone-free Phexxi® contraceptive gel in the Middle East to Pharma 1 Drug Store [2] - A partnership with Hello Alpha was established to offer Phexxi as a hormone-free contraception solution, targeting women on GLP-1s and those seeking hormone-free birth control [2] Recent Developments - Evofem's first FDA-approved product, Phexxi®, is a hormone-free, on-demand contraceptive vaginal gel, available in boxes of 12 pre-filled applicators [3] - The company is working towards closing a merger agreement with Aditxt, Inc., with the transaction expected to finalize in the second half of 2024 [4]

SAN DIEGO, July 25, 2024 (GLOBE NEWSWIRE) -- Women's health innovator Evofem Biosciences, Inc. ("Evofem" or "the Company") (OTCQB:EVFM) today announced that Saundra Pelletier, Chief Executive Officer and Amy Raskopf, Chief Business Development Officer, will present and host one-on-one meetings at the OTCQB Venture Virtual Investor Conference as follows: Date:Thursday, August 1, 2024Time:10:30am ETAccess Webcast:(live and archive)https://bit.ly/3LySuJNor archive: https://evofem.investorroom.com/events During ...

— Pharma 1 anticipates filing UAE regulatory submission for Phexxi as a hormone-free contraceptive in Q3 2024 — — UAE contraceptive drug market is projected to reach $185.1 million by 2030 — SAN DIEGO, July 23, 2024 /PRNewswire/ -- Women's health innovator Evofem Biosciences, Inc. (OTCQB: EVFM) and private Emirati health care company Pharma 1 Drug Store LLC have signed a License and Supply Agreement for the Middle East rights to Phexxi® (lactic acid, citric acid, potassium bitartrate), Evofem's FDA-approved ...

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES HALIFAX, Nova Scotia, July 18, 2024 (GLOBE NEWSWIRE) -- Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, announces that it has entered into a second amending agreement (the “Amending Agreement”) among the Company, Aditxt, Inc. (“Aditxt”) and Adivir, Inc. (“Adivir” and tog ...

Aditxt (NASDAQ:ADTX) stock is up on Wednesday after the biotech company announced an amended and restated merger agreement with Evofem Biosciences (OTCMKTS:EVFM).Aditxt notes that the merger agreement was amended and restated as Evofem Biosciences has some critical needs ahead of it. That includes interim financing and substituting cash for shares of ADTX stock in the merger.Aditxt also notes that it has acquired SOLOSEC from Lupin Limited. This grants Lupin Limited a potential of $84 million based on futur ...

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® (secni ...

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES HALIFAX, Nova Scotia, July 02, 2024 (GLOBE NEWSWIRE) -- Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, announces that it has entered into an amending agreement (the “Amending Agreement”) among the Company, Aditxt, Inc. (“Aditxt”) and Adivir, Inc. (“Adivir” and together ...

— Leading telemedicine company expands offering with hormone-free birth control as GLP-1 medication usage increases —— Hello Alpha partnership boosts awareness of and access to Phexxi for millions of women —SAN DIEGO, June 27, 2024 /PRNewswire/ -- Women's health innovator Evofem Biosciences, Inc. (OTCQB: EVFM) today announced a new market partnership with Hello Alpha, a telemedicine company with a medical team specifically trained for a woman's unique needs, to offer Phexxi® (lactic acid, citric acid and po ...