Aditxt, Inc. (Nasdaq: ADTX) (“Aditxt” or the “Company”), a biotech innovation company developing and commercializing technologies focused on monitoring and modulating the immune system, today provides shareholders with a corporate update following the completion of a reverse stock split and closing of a previously announced $20 million public offering.
“Aditxt’s key to success is multifaceted and tied to the success of each of the Company’s programs, which currently include AditxtScore™, Adimune™ and Adivir™. The successful completion of the reverse stock split and the closing of our public offering were critical to continuing the progress within each of these programs toward commercialization, and as we work toward regaining compliance with Nasdaq’s continued listing requirements,” said Amro Albanna, co-founder, chairman and CEO of Aditxt. “We are extremely encouraged by the support and adoption our technologies are receiving in various healthcare sectors as we track toward key inflection points in 2023.”
Since the Company’s initial public offering on July 2, 2020, we believe that Aditxt has become well positioned to address some of the most challenging immune-related diseases. The Company is developing technologies specifically aimed at improving the health of the immune system through immune modulation and monitoring.
Aditxt’s Innovation Portfolio includes:
AditxtScore™ is a high precision platform that enables a comprehensive, individualized immune profile for a variety of disease states impacting an individual’s immune system and overall health. It can be informative for measuring and monitoring individual immune responses to viruses, bacterial antigens, peptides, drugs, bone marrow and solid organ transplants, and cancer. The technology can assist physicians and patients manage “health by the numbers” through quantifying immune responses specific to the individual’s unique biology and risk profile.
Aditxt’s first application, AditxtScore™ for COVID-19, is a multiplexed assay that we believe holds great clinical utility in helping determine optimal timing for vaccines and boosters based on objective data. This is particularly important as immunity from previous infection, vaccines, and/or boosters begins to wane and a potential new wave of variants approaches. AditxtScore™ for COVID-19 is gaining adoption through various channels, including physician markets, referring labs, long-term care facilities, and employers.
AditxtScore™ began realizing revenue in Q4, 2021, and continues to deliver revenue growth quarter-over-quarter. AditxtScore™ is receiving reimbursement from Medicare, commercial payors and cash channels. AditxtScore™ has a robust pipeline of key innovations that it is planning to launch, including a general immune and long COVID blood panel. AditxtScore™ is also actively exploring point-of-care opportunities with independent and big box pharmacies.
Adimune™ is an Aditxt program with the mandate to develop Aditxt’s immune modulation therapeutic portfolio. Adimune’s™ nucleic acid-based technology, called Apoptotic DNA Immunotherapy™ (“ADi™”), is unique in that it is designed to mimic the body’s natural mechanism to maintain immune tolerance, thereby restoring immune health in autoimmune disease and inducing tolerance in organ transplantation. Our pre-clinical experiments have demonstrated that there is no immunosuppression involved, and the ability to fight infection and tumor is not impaired. Safety and tolerability have been shown in the toxicology study, the completion of which has been reported recently, demonstrating no adverse effects.
Adimune™ is now initiating GMP manufacturing and product stability studies to complete the pre-clinical program. The Clinical Trial Application (CTA) will be submitted in Q1 2023, with the aim to start clinical studies for Psoriasis in Q3 2023. Adimune™ will be developing ADi™ products for organ transplantation including skin allografting, autoimmune diseases with the initial focus on psoriasis and Type I Diabetes. We believe the ADi™ technology platform can be engineered to address a wide variety of indications.
- Adivir™ is Aditxt’s Antiviral program representing a $30 million revenue sharing agreement signed in April 2022 with Cellvera, a commercial-stage biopharmaceutical company, for its antiviral therapeutics’ agent, “Favipiravir.” Under terms of the agreement, Aditxt will receive up to 10% of net sales of products and services collected by Cellvera up to a maximum of $30 million. The agreement with Cellvera is designed to drive strategic revenue and growth and provide enhanced security for Aditxt’s $14.5 million loan to Cellvera.
As a result of the reverse stock split, and shortly after the public offering the Company’s capital structure is well positioned to execute its plans. Following the completion of the reverse split and public offering, Aditxt has 3,708,647 shares outstanding and 100,000,000 shares authorized, as of September 23, 2022.
About Aditxt Inc.
Aditxt is a biotech innovation company developing and commercializing technologies focused on monitoring and modulating the immune system. Aditxt’s immune monitoring technologies are designed to provide a personalized immune profile. Aditxt’s immune modulating technologies, currently preclinical, are being developed to retrain the immune system to induce tolerance to address rejection of transplanted organs, autoimmune diseases and allergies.
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 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 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.