Latest news with #Adimune
Business Wire
11-08-2025
- Business
- Business Wire
Aditxt and Crypto.com Sign Agreement for Custodial Crypto Account, Announce ADTX Share Access on Crypto.com as Part of the Larger bitXbio™ Initiative
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Aditxt, Inc. (Nasdaq: ADTX) ("Aditxt" or the "Company"), a social innovation platform dedicated to accelerating promising health innovations,announced today that it has signed a custody agreement with a global leader in digital asset platforms, to establish a custodial crypto account. The agreement is a foundational step in the broader planned rollout of bitXbio™ —Aditxt's crypto-native social platform bridging Fintech and Biotech. Under the agreement will serve as the custodian for Aditxt's proposed digital treasury, supporting its planned strategy to back biotech innovation with a reserve of digital assets including Bitcoin. Additionally, ADTX common stock is now tradable through broker-dealer, providing a more seamless opportunity for crypto native retail and institutional investors to trade ADTX. Custody, institutional-grade custody offering, will provide the custodial services. Custody offers custody services to eligible institutions and high-net-worth clients through a comprehensive, end-to-end solution with safety and security at its core. 'Businesses across industries are strategically planning for the future with digital asset treasuries,' said Eric Anziani, President and Chief Operating Officer of 'We are pleased to support Aditxt and its pioneering bitXbio initiative with our best-in-class custodial capabilities and as they look to engage crypto native traders.' The initiative is part of Aditxt's bitXbio™ platform, which aims to expand access to innovations in immune reprogramming (Adimune), early cancer detection (Pearsanta), women's health (Adifem) and other innovations with the potential of addressing some of the most pressing health challenges. 'We believe that this agreement is a key step in aligning our biotech assets with a next-generation financial infrastructure,' said Amro Albanna, Co-founder and CEO of Aditxt. 'By engaging for custody and access, we are laying the foundation for a new kind of platform—where value is not only created through innovation but made accessible to all through digital finance.' About Founded in 2016, is trusted by more than 150 million customers worldwide and is the industry leader in regulatory compliance, security and privacy. Our vision is simple: Cryptocurrency in Every Wallet™. is committed to accelerating the adoption of cryptocurrency through innovation and empowering the next generation of builders, creators, and entrepreneurs to develop a fairer and more equitable digital ecosystem. About Aditxt, Inc. Aditxt, Inc. is a social innovation platform accelerating promising health innovations. Aditxt's ecosystem of research institutions, industry partners, and shareholders collaboratively drives their mission to "Make Promising Innovations Possible Together." The 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 that democratizes innovation, ensures every stakeholder's voice is heard and valued, and empowers collective progress. The Company currently operates two programs focused on immune health and precision health. Through the proposed acquisition of Evofem under the July 2024 Amended and Restated Merger Agreement between Evofem, Aditxt and Adifem, as amended (the "A&R Merger Agreement"), Aditxt aims to introduce an additional program dedicated to women's health. The companies are working toward a targeted close in the second half of 2025. The closing of the transaction with Evofem is subject to several conditions, including but not limited to approval of the transaction by Evofem's shareholders and Aditxt raising sufficient capital to fund its obligations at closing. These obligations include cash payments of approximately $17 million for Evofem, which includes approximately $15.0 million required to satisfy Evofem's senior secured noteholder; should Aditxt fail to secure these funds, Evofem's senior secured noteholder is expected to seek to prevent the closing of the merger with Evofem. No assurance can be provided that all of the conditions to closing will be obtained or satisfied or that the transaction will ultimately close. 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. Words such as, but not limited to, "achieving," "advancing", "aim," "are working to," "believe," "completing," "continue," "could," "design," "estimate," "expect," "intend," "may," "might," "plan," "possible," "potential," "predict," "project," "seek," "should," "suggest," "strategy," "target," "will," "would," and similar expressions or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include but are not limited to anticipated availability of funds to pursue the purchase of digital assets; Aditxt's ability to successfully execute its mission to accelerate and monetize promising health innovations, and magnitude thereof; Aditxt's ability to complete the proposed initial public offering of Pearsanta on the proposed timeline, if at all; Aditxt's ability to close the planned acquisition of Evofem, including to meet all closing conditions, and the timing thereof; and anticipated availability of funds to pursue the purchase of digital assets by Aditxt. 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 each company's SEC filings, including Aditxt's Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 31, 2025, and any subsequent Form 10-Q filings. All forward-looking statements are expressly qualified in their entirety by such factors. Aditxt undertakes no duty to update any forward-looking statement except as required by law. For more information, please visit Follow Aditxt on:
Business Wire
05-06-2025
- Business
- Business Wire
Saundra Pelletier, Evofem Biosciences' CEO, Dr. Friedrich Kapp, Co-CEO of Adimune, and Chris Mitton, President of Pearsanta, Will Join Aditxt Weekly Update on June 6
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)-- Aditxt, Inc. (Nasdaq: ADTX) ('Aditxt'), a social innovation platform accelerating promising health innovations, today announced that its CEO Amro Albanna will be joined for tomorrow's Aditxt Weekly Update by Dr. Friedrich Kapp, Chris Mitton, and Evofem Biosciences' CEO Saundra Pelletier to discuss progress in immune therapy, early disease detection and women's health, respectively. Friedrich Kapp, M.D, Ph.D. is co-CEO of Adimune, Inc.('Adimune'), which is advancing its lead therapeutic candidate ADI-100™ towards an Investigational New Drug ('IND') submission to enable initiation of clinical trials with the antigen-specific gene therapy. ADI-100 is designed to restore immune tolerance in autoimmune diseases by targeting specific antigens, like glutamic acid decarboxylase, and establish tolerance in organ transplantation. Dr. Kapp, a 30+ year veteran of the pharmaceutical industry, was formerly president of the Therapeutics Business Unit at Schering AG. Chris Mitton was appointed president of Pearsanta, Inc. ('Pearsanta') in September 2024 to drive the advancement of its Mitomic ® diagnostic tests for endometriosis and prostate cancer. A seasoned veteran of the healthcare industry with over 20 years of leadership experience in the medical diagnostics sector and a strong focus on personalized healthcare and molecular oncology diagnostics, Mr. Mitton concurrently serves as CEO of MDNA Life Sciences Inc., a pioneer in the development of liquid biopsy tests. Saundra Pelletier is president, CEO and Chairman of the Board of Evofem Biosciences, Inc. (OTCPK: EVFM) ('EvoFem'). Her deep insight in women's health is driven by intensive consumer research and more than three decades of commercial experience in the global markets with products addressing women's health spanning every stage in their reproductive journey, from puberty to menopause. During her career, including her ten-year tenure at Evofem, she has launched pharmaceutical brands worldwide and expanded indications for female healthcare brands in multiple countries. Ms. Pelletier is a published author, TEDx and keynote speaker, executive coach and staunch advocate for innovation in women's healthcare. Pearsanta and Adimune are wholly-owned subsidiaries of Aditxt. About Aditxt, Inc. Aditxt, Inc. ('Aditxt') is a social innovation platform accelerating promising health innovations. Aditxt's ecosystem of research institutions, industry partners, and shareholders collaboratively drives their mission to "Make Promising Innovations Possible Together." The 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 that democratizes innovation, ensures every stakeholder's voice is heard and valued, and empowers collective progress. The Company currently operates two programs focused on immune health and precision health. Through the planned acquisition of Evofem BioSciences, Inc. ('EvoFem')under the July 2024 Amended and Restated Merger Agreement between Evofem, Aditxt and Adifem, Inc. (jointly 'the Parties'), as amended (the 'A&R Merger Agreement'), Aditxt aims to introduce an additional program dedicated to women's health. The companies are working toward a targeted close in the second half of 2025. For more information, please visit Follow Aditxt on: Aditxt™, Adimune™, ADI-100™, Pearsanta™, are trademarks and Mitomic ® is a registered trademarks of Aditxt, Inc. 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. Words such as, but not limited to, "achieving," 'advancing', "aim," 'are working to,' "believe," "completing," "continue," "could," "design," "estimate," "expect," "intend," "may," "might," "plan," "possible," "potential," "predict," "project," "seek," "should," "suggest," "strategy," "target," "will," "would," and similar expressions or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. 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 each company's SEC filings, including Aditxt's Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 31, 2025, and any subsequent Form 10-Q filings. All forward-looking statements are expressly qualified in their entirety by such factors. Aditxt does not undertake any duty to update any forward-looking statement except as required by law.
Business Wire
02-05-2025
- Business
- Business Wire
Upcoming Aditxt Weekly Update to Feature Dr. Shahrokh Shabahang, Chief Innovation Officer (CIO) of Aditxt™, and Dr. Friedrich Kapp, Co-CEO of Adimune™, to Discuss Progress of Lead Therapeutic Candidate ADI-100™
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Aditxt, Inc. (NASDAQ: ADTX) ("Aditxt" or the "Company"), a social innovation platform accelerating promising health innovations, announced that Aditxt's CIO Dr. Shahrokh Shabahang, and Adimune's Co-CEO Dr. Friedrich Kapp, will join today's Aditxt Weekly Update to discuss recent developments related to ADI-100™, the lead therapeutic candidate of its wholly owned subsidiary, Adimune. About Adimune Adimune is a pre-clinical stage biopharmaceutical company pioneering a new class of immune modulation therapies designed to restore natural immune tolerance. Adimune's mission is to advance immune health by providing targeted, long-term solutions that minimize reliance on chronic immunosuppression—transforming treatment for autoimmune diseases and organ transplantation. One of Adimune's innovations is ADI-100™, a first-in-class Apoptotic DNA Immunotherapy™ that mimics the body's natural mechanisms for maintaining immune tolerance. This proprietary platform uses nucleic acid technology to deliver two coordinated signals: one encoding BAX, a protein that promotes targeted apoptosis, and another encoding a modified disease-specific antigen to re-establish immune tolerance. To learn more and view the corporate presentation, please visit About ADI-100 ADI-100™ is an investigational antigen-specific gene therapy that consists of two DNA molecules designed to restore immune tolerance in autoimmune diseases or to induce tolerance to transplanted organs. This approach is designed to retrain the immune system to recognize antigens as "self" without relying on immunosuppression, offering the possibility of significant safety and efficacy benefits. The therapy consists of a pro-apoptotic DNA molecule (BAX), which has been shown in preclinical models to induce localized apoptotic cell death combined with a modified form of GAD to retrain the immune system to become tolerant to the antigen. ADI-100™ is designed to work through precision immune reprogramming, downregulating pro-inflammatory cytokines while upregulating anti-inflammatory cytokines in an antigen-specific manner. It tolerizes to GAD, which is a target of autoimmunity, directly or indirectly involved in Type 1 Diabetes, Psoriasis, and certain CNS autoimmune disorders. In the mouse model for type 1 diabetes, ADI-100™ demonstrated a reduction in the number of aggressive T cells directed against insulin, which is another antigen in the pancreas that is a target of autoimmune attack. This bystander effect is an important factor to counteract a phenomenon often observed where autoimmunity spreads to other regions of a protein or to other proteins in a cell. Another potential benefit of downregulating anti-GAD antibodies by ADI-100™ is restoration of GABA levels, further enhancing the tolerization process. About Aditxt, Inc. Aditxt, Inc. ® is a social innovation platform accelerating promising health innovations. Aditxt's ecosystem of research institutions, industry partners, and shareholders collaboratively drives their mission to "Make Promising Innovations Possible Together." The 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 that democratizes innovation, ensures every stakeholder's voice is heard and valued, and empowers collective progress. Aditxt currently operates two programs focused on immune health and precision health. The Company plans to introduce two additional programs dedicated to public health and women's health. For these, Aditxt has entered into an Arrangement Agreement with Appili Therapeutics, Inc. ('Appili') (TSX: APLI; OTCPink: APLIF), which focuses on infectious diseases, and a Merger Agreement with Evofem Biosciences, Inc. ('Evofem') (OTCQB: EVFM). Each program will be designed to function autonomously while collectively advancing Aditxt's mission of discovering, developing, and deploying innovative health solutions to tackle some of the most urgent health challenges. The closing of each of the transactions with Appili and Evofem is subject to several conditions, including but not limited to approval of the transactions by the respective target shareholders and Aditxt raising sufficient capital to fund its obligations at closing. These obligations include cash payments of approximately $17 million for Appili and $17 million for Evofem, which includes approximately $15.2 million required to satisfy Evofem's senior secured noteholder; should Aditxt fail to secure these funds, Evofem's senior secured noteholder is expected to seek to prevent the closing of the merger with Evofem. No assurance can be provided that all of the conditions to closing will be obtained or satisfied or that either of the transactions will ultimately close. For more information, Follow us on: LinkedIn: Facebook: 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 its strategic M&A initiatives; the Company's ability to 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; expected usage of the Company's ELOC and ATM facilities; 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 Aditxt'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.
Associated Press
17-04-2025
- Business
- Associated Press
Dr. Charles Howe of the Mayo Clinic's Neuroimmunology Department to Join Aditxt Weekly Update on May 2, 2025, to Discuss Newly Announced Preclinical Study Results Sponsored by Aditxt's Subsidiary Adimune™
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Apr 17, 2025-- Aditxt, Inc. (NASDAQ: ADTX) ('Aditxt' or the 'Company'), a social innovation platform accelerating promising health innovations, announced that Dr. Charles Howe, Chair of the Division of Experimental Neurology and Director of Research at the Mayo Clinic Center for Multiple Sclerosis and Autoimmune Neurology, will join the Aditxt Weekly Update on May 2, 2025, to discuss key findings from the newly announced preclinical study evaluating ADI-100™, the lead therapeutic candidate developed by its wholly owned subsidiary, Adimune™, Inc. ('Adimune'). Featured participants will include Dr. Shahrokh Shabahang, Chief Innovation Officer of Aditxt, Inc., and Dr. Friedrich Kapp, Co-Chief Executive Officer of Adimune™, Inc. Date: Friday, May 2, 2025 Time: 11:30 a.m. ET Location: Virtual (Zoom) Registration:Click here to register About Adimune Adimune is a pre-clinical stage biopharmaceutical company pioneering a new class of immune modulation therapies designed to restore natural immune tolerance. Adimune's mission is to advance immune health by providing targeted, long-term solutions that minimize reliance on chronic immunosuppression—transforming treatment for autoimmune diseases and organ transplantation. One of Adimune's innovations is ADI-100™, a first-in-class Apoptotic DNA Immunotherapy™ that mimics the body's natural mechanisms for maintaining immune tolerance. This proprietary platform uses nucleic acid technology to deliver two coordinated signals: one encoding BAX, a protein that promotes targeted apoptosis, and another encoding a modified disease-specific antigen to re-establish immune tolerance. To learn more and view the corporate presentation, please visit About ADI-100 ADI-100™ is an investigational antigen-specific gene therapy that consists of two DNA molecules designed to restore immune tolerance in autoimmune diseases or to induce tolerance to transplanted organs. This approach is designed to retrain the immune system to recognize antigens as 'self' without relying on immunosuppression, offering the possibility of significant safety and efficacy benefits. The therapy consists of a pro-apoptotic DNA molecule (BAX), which has been shown in preclinical models to induce localized apoptotic cell death combined with a modified form of GAD to retrain the immune system to become tolerant to the antigen. ADI-100™ is designed to work through precision immune reprogramming, downregulating pro-inflammatory cytokines while upregulating anti-inflammatory cytokines in an antigen-specific manner. It tolerizes to GAD, which is a target of autoimmunity, directly or indirectly involved in Type 1 Diabetes, Psoriasis, and certain CNS autoimmune disorders. In the mouse model for type 1 diabetes, ADI-100™ demonstrated a reduction in the number of aggressive T cells directed against insulin, which is another antigen in the pancreas that is a target of autoimmune attack. This bystander effect is an important factor to counteract a phenomenon often observed where autoimmunity spreads to other regions of a protein or to other proteins in a cell. Another potential benefit of downregulating anti-GAD antibodies by ADI-100™ is restoration of GABA levels, further enhancing the tolerization process. About Aditxt, Inc. Aditxt, Inc.® is a social innovation platform accelerating promising health innovations. Aditxt's ecosystem of research institutions, industry partners, and shareholders collaboratively drives their mission to 'Make Promising Innovations Possible Together.' The 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 that democratizes innovation, ensures every stakeholder's voice is heard and valued, and empowers collective progress. Aditxt currently operates two programs focused on immune health and precision health. The Company plans to introduce two additional programs dedicated to public health and women's health. For these, Aditxt has entered into an Arrangement Agreement with Appili Therapeutics, Inc. ('Appili') (TSX: APLI; OTCPink: APLIF), which focuses on infectious diseases, and a Merger Agreement with Evofem Biosciences, Inc. ('Evofem') (OTCQB: EVFM). Each program will be designed to function autonomously while collectively advancing Aditxt's mission of discovering, developing, and deploying innovative health solutions to tackle some of the most urgent health challenges. The closing of each of the transactions with Appili and Evofem is subject to several conditions, including but not limited to approval of the transactions by the respective target shareholders and Aditxt raising sufficient capital to fund its obligations at closing. These obligations include cash payments of approximately $17 million for Appili and $17 million for Evofem, which includes approximately $15.2 million required to satisfy Evofem's senior secured noteholder; should Aditxt fail to secure these funds, Evofem's senior secured noteholder is expected to seek to prevent the closing of the merger with Evofem. No assurance can be provided that all of the conditions to closing will be obtained or satisfied or that either of the transactions will ultimately close. For more information, Follow us on: LinkedIn: Facebook: 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 its strategic M&A initiatives; the Company's ability to 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; expected usage of the Company's ELOC and ATM facilities; 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 Aditxt'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. View source version on CONTACT: Aditxt, Inc. Corporate Communications Jeff Ramson, PCG Advisory, Inc. T: 646-863-6893 [email protected] KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA INDUSTRY KEYWORD: SCIENCE NEUROLOGY BIOTECHNOLOGY RESEARCH PHARMACEUTICAL HEALTH GENETICS CLINICAL TRIALS SOURCE: Aditxt, Inc. Copyright Business Wire 2025. PUB: 04/17/2025 08:15 AM/DISC: 04/17/2025 08:15 AM
Associated Press
06-03-2025
- Business
- Associated Press
Aditxt Subsidiary Adimune to Ship Drug Substances for Final Drug Product Formulation of ADI-100 Ahead of Planned Clinical Trials in Type 1 Diabetes and Psoriasis in Germany, and Stiff Person Syndrome at the Mayo Clinic in the U.S.
Aditxt, Inc. (NASDAQ: ADTX) ('Aditxt' or the 'Company'), a social innovation platform dedicated to accelerating promising health innovations, today provided an update on its subsidiary, Adimune, Inc., ('Adimune') and its progress in advancing ADI-100, an investigational product candidate to be studied in patients with Psoriasis, Type I Diabetes (T1D) and Stiff Person Syndrome. Adimune's mission is to address the root causes of autoimmune diseases. By harnessing the body's natural ability to restore and maintain immune tolerance, Adimune strives to deliver innovative solutions that improve lives without the risks of immunosuppression. As a subsidiary of Aditxt, Adimune continues to advance its novel immune modulation therapy, the ADI platform, for autoimmune diseases toward first-in-human clinical trials. Aditxt provides critical support, resources, and infrastructure to drive regulatory and clinical progress, helping move ADI-100, its first product candidate based on the ADI platform, into its next phase of development with a focus on demonstrating safety and efficacy in autoimmune disease treatment. Status Update All preclinical studies of Adimune's first product candidate, ADI-100, have been completed, and the shipment of the drug substances for final drug product formulation are planned for March. These studies have provided several data points supporting the potential effectiveness of ADI-100 in restoring durable tolerance over the 10-month duration of the T1D studies both in prevention and treatment study designs. Preclinical safety and toxicology studies have shown absence of drug toxicity, no antibody formation to the drug product, and a lack of persistence in all organs evaluated. Furthermore, Adimune has demonstrated in three separate preclinical studies that ADI-100 does not impair the responsiveness of the immune system to combat infection, cancer, or the tumor fighting capabilities of checkpoint inhibitors. Good Manufacturing Process (GMP) clinical-grade drug substances have been successfully manufactured by a qualified contract manufacturer. Upon shipment, the clinical grade drug substances will be formulated into the final drug product, ready for stability testing, and use in the clinical trials pending required regulatory submissions. Lastly, two remaining drug product release assays specifically designed for ADI-100 are in the final stages of validation to be used once the final drug product is ready. Preclinical and manufacturing data, including the clinical-grade drug substance, are essential components of the complete dossier that we intend to submit to the regulatory agencies, which evaluate the safety and quality of the final drug product to be administered in the clinical trials. Adimune has had pre-submission meetings with the regulatory agency in Germany and has completed the additional studies requested. For the clinical trials that are planned in Germany, Adimune has engaged with a Contract Research Organization (CRO) to manage the process, including site selection. In parallel, Adimune is working with the Mayo Clinic to prepare the IND package for FDA submission and is awaiting a pre-IND meeting expected in the second quarter of this year to review the package before full submission. ' Adimune is committed to developing a transformative approach to autoimmunity—one that focuses on restoring immune tolerance rather than suppressing the immune system,' said Dr. Friedrich Kapp, Co-CEO of Adimune. 'With the shipment of ADI-100 drug substance soon underway, we are moving toward clinical trials and remain focused on executing the necessary steps to ensure the highest standards of safety, efficacy and regulatory compliance. We are completing key milestones that will allow us to advance the ADI-100 drug product into human studies and bring us closer to a potential paradigm shift in autoimmune disease treatment.' Amro Albanna, Co-Founder, Chairman and CEO of Aditxt, added, 'This milestone underscores the significant progress Adimune has made in bringing ADI and ADI-100 to the clinic, with the shipment of the drug substance marking a critical step in that journey. Adimune exemplifies Aditxt's mission of identifying and accelerating disruptive health innovations. By providing the support and infrastructure needed to advance ADI-100 toward clinical trials, we are reinforcing our commitment to addressing autoimmune diseases as one of the most pressing health challenges we face today.' About ADI-100 ADI-100 is an investigational, innovative antigen-specific gene therapy that consists of two DNA molecules designed to restore immune tolerance in autoimmune diseases or to induce tolerance to transplanted organs. A key target of ADI-100 is Glutamic Acid Decarboxylase (GAD), an enzyme implicated in Type 1 Diabetes, Stiff Person Syndrome, and several other autoimmune conditions. This approach is designed to retrain the immune system to recognize antigens as 'self' without relying on immunosuppression, offering the possibility of significant safety and efficacy benefits. The therapy consists of a DNA molecule that encodes a pro-apoptotic protein (BAX), which has been shown in preclinical models to induce localized apoptotic cell death leading to recruitment of key immune cells called dendritic cells combined with a methylated DNA molecule that encodes a modified form of GAD to retrain the immune system to become tolerant to the antigen. ADI-100 is designed to work through precision immune reprogramming, downregulating pro-inflammatory cytokines while upregulating anti-inflammatory cytokines in an antigen-specific manner. It is designed to tolerize to GAD, which is a target of autoimmunity, directly or indirectly involved in Type 1 diabetes, psoriasis, and certain central nervous system autoimmune disorders. In the mouse model for type 1 diabetes, ADI-100 demonstrated a reduction in the number of aggressive T cells directed against insulin, another antigen in the pancreas that is a target of autoimmune attack. This bystander effect is an important factor to counteract a phenomenon often observed where autoimmunity spreads to other regions of a protein or to other proteins in a cell. Another potential benefit of downregulating anti-GAD antibodies by ADI-100 is restoration of GABA levels, further enhancing the tolerization process. To learn more and view the corporate presentation, please visit About Aditxt Aditxt, Inc.® is a social innovation platform dedicated to accelerating promising health innovations. Aditxt's ecosystem of research institutions, industry partners and shareholders collaboratively drive their mission to 'Make Promising Innovations Possible Together.' The 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 that democratizes innovation, ensures every stakeholder's voice is heard and valued, and empowers collective progress. Aditxt currently operates two programs focused on immune health and precision health. The Company plans to introduce two additional programs dedicated to public health and women's health. For these, Aditxt has entered into an Arrangement Agreement with Appili Therapeutics, Inc. ('Appili') (TSX: APLI; OTCPink: APLIF), which focuses on infectious diseases, and a Merger Agreement with Evofem Biosciences, Inc. ('Evofem') (OTCQB: EVFM). Each program will be designed to function autonomously while collectively advancing Aditxt's mission of discovering, developing and deploying innovative health solutions to tackle some of the most urgent health challenges. The closing of each of the transactions with Appili and Evofem is subject to several conditions, including but not limited to approval of the transactions by the respective target shareholders and Aditxt raising sufficient capital to fund its obligations at closing. These obligations include cash payments of approximately $17 million for Appili and $17 million for Evofem, which includes approximately $15.2 million required to satisfy Evofem's senior secured noteholder; should Aditxt fail to secure these funds, Evofem's senior secured noteholder is expected to seek to prevent the closing of the merger with Evofem. On Dec. 23, 2024, Evofem announced the cancellation of its special stockholders meeting and the withdrawal of the merger proposal with Aditxt from consideration by the stockholders. No assurance can be provided that all of the conditions to closing will be obtained or satisfied or that either of the transactions will ultimately close. For more information, 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 its strategic M&A initiatives; the Company's ability to 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; expected usage of the Company's ELOC and ATM facilities; 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 Aditxt'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. SOURCE: Aditxt, Inc. Copyright Business Wire 2025. PUB: 03/06/2025 08:15 AM/DISC: 03/06/2025 08:17 AM
