Appili has a commercial-stage pipeline, has raised CAD $100M towards developing therapeutics for the global infectious disease and biodefense markets, and subject to the renewal of certain legislation, two programs potentially eligible for FDA Priority Review Vouchers

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Oct. 10, 2024-- Aditxt, Inc. (“Aditxt” or the “Company”) (NASDAQ: ADTX), an innovation platform dedicated to accelerating promising health innovations with two existing programs focused on immune health and precision health,announced that Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (“Appili”) has commenced the mailing of its management information circular in connection with the upcoming special meeting of their shareholders, which will be held virtually on November 6, 2024. Appili’s board of directors has recommended the shareholders’ vote in favor of the proposed acquisition by Aditxt.

Since its founding in 2015, over CAD $100 million has been raised towards developing antivirals and vaccines for emerging and neglected infectious agents to address a wide range of urgent medical needs in infectious diseases and biodefense. As a result, Appili’s portfolio includes LIKMEZ™, the first and only FDA-approved, taste-masked oral liquid suspension form of the antibiotic, metronidazole. LIKMEZ addresses an unmet need in patients, such as children and the elderly, who have trouble swallowing large pills. LIKMEZ was commercially launched by Saptalis Pharmaceuticals LLC in 2023, and the product is now available to patients and doctors in the United States. Appili has the right to receive sales-based milestone payments and royalties from Saptalis based on sale of the product.

In addition, Appili has two programs, ATI-1701 and 1801, which, subject to the renewal of certain legislation, are potentially eligible for FDA Priority Review Vouchers (PRVs). A PRV enables its recipient to expedite the review process for future drug applications upon issuance. While PRVs can be traded, and recent transactions averaged approximately $100 million, their strategic value can potentially extend beyond the secondary market, offering significant advantages in accelerating the development timeline of new treatments.

ATI-1701 is a live attenuated vaccine that targets tularemia. This bacterial infection caused by Francisella tularensis is potentially 1,000 times more infectious than anthrax, posing significant threats to public health and national security and, thus, classified as a Category A pathogen by the National Institutes of Health for its potential use in bioterrorism. ATI-1701 has been awarded a total of $14 million in U.S. Air Force Academy funding commitments, facilitating essential activities like manufacturing, non-clinical studies, and regulatory activities for an Investigational New Drug (IND) application, positioning ATI-1701 as a pivotal element in biodefense strategies. ATI-1801 is another program representing a topical antiparasitic product licensed by the US Army Medical Materiel Development Activity.

ATI-1801 is in advanced clinical trials. This novel topical formulation is being developed to combat cutaneous leishmaniasis (CL), a devastating disease causing disfiguring skin lesions and affecting hundreds of thousands of people annually, primarily in tropical and subtropical regions. Recognized by the World Health Organization as a Neglected Tropical Disease, CL presents significant social and economic challenges, particularly in impoverished communities. CL leads to severe physical deformities and social stigma, contributing to isolation and diminished quality of life for those affected. This novel topical formulation of paromomycin provides a more comfortable application of the anti-infective agent to treat CL’s painful and disfiguring lesions effectively.

Amro Albanna, Co-Founder, Chairman, and CEO of Aditxt, commented, “Completing the acquisition of Appili would be another vehicle to expand Aditxt’s reach in addressing infectious diseases with commercial or clinical development programs. The strategic importance of Appili’s work in developing treatments and vaccines for infectious diseases and medical countermeasures could impact millions of people around the globe. We believe Appili’s team and asset portfolio could address some of the most urgent public health challenges, including antibiotic-resistant infections and bioterrorism threats.”

Dr. Don Cilla, President and CEO of Appili Therapeutics, stated, “Appili’s board of directors recommends that shareholders vote in favor of the proposed acquisition by Aditxt, as this transaction aligns with our strategic goals and opens new opportunities across multiple fronts. Appili has received indications of support from approximately 29% of the total voting power. By leveraging the Aditxt’s platform, we will significantly enhance our ability to combat life-threatening infectious diseases, enabling us to expand our reach and impact. Our combined expertise will rapidly advance our mission to develop treatments for some of today’s most critical public health challenges.”

The closing of the transaction with Appili is subject to several conditions, including but not limited to approval of the transaction by Appili’s shareholders and Aditxt raising sufficient capital to fund its obligations at closing. No assurance can be provided that all of the conditions to closing will be obtained or satisfied or that the transaction will ultimately close.

About Aditxt, Inc.

Aditxt, Inc.® is an innovation platform dedicated to 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. (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. 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.

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About Appili

Appili is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. Appili is currently advancing a diverse range of anti-infectives, including an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. Led by a proven management team, Appili is at the epicenter of the global fight against infection.

For more information about Appili Therapeutics Inc., visit www.AppiliTherapeutics.com.

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; 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.

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Media Relations Contact:
Mary O’ Brien
mobrien@aditxt.com
(516) 753-9933

Source: Aditxt, Inc.