Aditxt: Avigan / Reeqonus Phase 3 Clinical Trial for the Treatment of COVID-19 Completed Enrollment of More than 1,200 Patients in the United States, Mexico and Brazil with Initial Results Expected in Less than 60 days – Form 8-K

Avigan / Reeqonus Phase 3 Clinical Trial for the Treatment of COVID-19 Completes Recruitment of More than 1,200 Patients in the United States, Mexico and Brazil, with Initial Results Expected in Less than 60 Days

Richmond, Virginia – October 5, 2021 – Aditxt, Inc. (“Aditxt”) (Nasdaq: ADTX), a biotechnology innovation company with a mission to improve immune system health, today announced that it has entered into a transaction agreement to achieve a definitive agreement by the end of November 2021 to acquire a subsidiary (“AiPharma”) of AiPharma Global Holdings LLC (“AiPharma Global”) which will own all the assets of AiPharma Global, a company focused on discovery, development and the commercialization of antiviral therapies in a wide range of infectious diseases.

AiPharma Global is a biopharma company that owns directly, or through its subsidiaries worldwide (excluding Japan), exclusive rights to Avigan / Reeqonus / Qifenda and all formulations of favipiravir, a broad spectrum oral antiviral drug that targets COVID-19 and other infectious diseases. The binding agreement follows Aditxt’s prior announcement on August 25, 2021 to acquire the company and Aditxt’s financing of a bridge loan to AiPharma Global in the amount of $ 6.5 million.

The acquisition, if completed, will form a business segment for Aditxt that focuses on the surveillance and treatment of infectious diseases. Key terms of the agreement include: an increase in the amount of borrowings authorized under Aditxt’s secured loan to AiPharma Global of $ 8.5 million, resulting in total availability of $ 15 million, as well as the issuance by Aditxt of a number of common shares which brings in $ 65 million. % of the number of shares in circulation of Aditxt calculated as of September 30, 2021 to be issued only at the closing of the transaction.

Acquisition is subject to confirmatory due diligence, completion of a definitive agreement based on agreed terms and other closing conditions, including regulatory, board, shareholder and Nasdaq approvals. . There can be no assurance that the foregoing approvals will be granted.

Highlights of the acquisition of AiPharma:

·

Avigan has received full marketing authorization or emergency use authorization in a number of markets as a treatment for COVID-19, including Mexico, India, Indonesia, Thailand and Malaysia, many other countries purchasing the drug under compassionate use programs including UK, US. Arab Emirates, Greece, Hungary and Saudi Arabia.

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AiPharma Global generates revenues from worldwide sales outside of the US and Canada of Avigan / Reeqonus through its 50% interest in Global Response Aid (“GRA”). GRA is part of a consortium that includes Appili Therapeutics (TSX: APLI; OTCQX: APLIF), Dr. Reddy’s Laboratories (NYSE: RDY), Agility (KSE / DFM: AGLTY) and FUJIFILM Toyama Chemical Co. Ltd, a subsidiary of FUJIFILM Holdings (FUJIY). Members of the consortium work together to coordinate and accelerate the global development of Avigan / Reeqonus.

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Consortium partner Appili Therapeutics is conducting a global Phase 3 trial evaluating Avigan / Reeqonus as a home oral therapy for COVID-19 and recently announced the completion of patient recruitment with frontline data expected in approximately 60 days .

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AiPharma Global recently agreed to acquire a major stake in Appili Therapeutics to strengthen its collaboration on the development of favipiravir and other treatments for infectious diseases. AiPharma Global expects to own 19.4% of the issued and outstanding Appili shares following the closing of its scheduled transaction in the fourth quarter of 2021.

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Favipiravir is a selective viral RNA-dependent RNA polymerase (RdRP) inhibitor with potent antiviral activity against single-stranded RNA viruses, including coronaviruses. Avigan / Reeqonus / Qifenda is uniquely positioned to deal with the current COVID-19 pandemic and future viral outbreaks.

“Successful completion of this acquisition would accelerate our infectious disease marketing plans and uniquely position Aditxt by combining our commercialized AditxtScoreMT for COVID-19 testing with home treatment for the disease. While initially targeting COVID-19, our combined clinical and commercial platform could potentially address unmet needs in other viral indications, ”said Amro Albanna, co-founder and CEO of Aditxt. “We look forward to partnering with the AiPharma team and members of its consortium. ”

Dr Alessandro Gadotti, CEO of AiPharma Group said: “We believe the combination of Aditxt and AiPharma is uniquely positioned to address the key topics of the COVID-19 pandemic, starting with monitoring the immune status and outpatient treatment of the disease. over 1.5 million patients have been treated with our antiviral tablets. The strength of oral antiviral treatments like Avigan / Reeqonus in real terms is that they fight COVID-19 in the community, not in hospitals – which can significantly reduce the strain on health systems. Our common product portfolio puts us at the forefront of the fight against COVID-19 and preparing for a future pandemic. ”

About Avigan / Reeqonus / Qifenda (favipiravir)

Avigan / Reeqonus / Qifenda (favipiravir) is a broad spectrum antiviral oral tablet form developed by FUJIFILM Toyama Chemical Co., Ltd. (FFTC). Following promising clinical studies, Russia, Thailand, Indonesia, India and Malaysia have approved favipiravir-based antiviral drugs for emergency treatment of COVID-19.

Additional clinical trials for favipiravir in COVID-19 are underway in the United States, China, India and the United Kingdom. Unlike most other interventions researchers are evaluating in the COVID-19 indication, favipiravir has already been extensively studied in human trials outside of North America and has a safety profile. known, with over 3,000 subjects receiving at least one dose of the drug in controlled clinical trials. and over 30,000 people who have received Avigan in observational studies. The safety profile has been confirmed by the hundreds of thousands of patients who have received favipiravir during the COVID-19 pandemics in authorized countries. The oral tablet form of favipiravir may also offer community-based benefits over other COVID-19 interventions, which often require injection or intravenous administration.

Avigan is approved for manufacture and sale in Japan as an anti-influenza virus medicine and as a treatment and storage countermeasure for pandemic influenza. The Japanese government has contracted with Fujifilm to purchase a stock of over 65 million tablets.

About Aditxt:

Aditxt develops technologies focused on improving the health of the immune system through immune monitoring and reprogramming. Aditxt’s immune monitoring technology is designed to provide a personalized comprehensive profile of the immune system. Aditxt’s immune reprogramming technology is currently in the preclinical stage and is designed to retrain the immune system to induce tolerance in the fight against transplant rejection, autoimmune diseases and allergies. For more information, please visit: www.aditxt.com

About AiPharma Global

AiPharma Global is a biopharmaceutical company focused on the discovery, development and commercialization of oral therapies to meet the unmet medical needs of patients with life-threatening viral diseases. Leveraging the company’s deep understanding of antiviral drug development, nucleotide chemistry, biology, biochemistry and virology, AiPharma Global has established a nucleotide prodrug platform to develop new product candidates to treat single-stranded ribonucleic acid, or ssRNA viruses, which cause serious viral illnesses. Currently, AiPharma Global is focused on the clinical and commercial development of orally available, potent and selective nucleotide prodrugs for difficult-to-treat and life-threatening viral infections, including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 ), the virus that causes COVID-19, dengue fever, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). AiPharma Global also owns the exclusive commercial rights for Avigan in Russia and China.

For more information, please visit www.aipharmalab.com.

Forward-looking statements

Certain statements contained 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, analysis or current expectations regarding, among other things, the ongoing and planned development of the Company’s products and activities; the Company’s intellectual property position; the Company’s ability to develop business functions; product launch expectations and revenue; the results of operations, cash requirements, expenses, financial condition, liquidity, prospects, growth and strategies of the Company; the industry in which the Company operates; and 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 such forward-looking statements due to various important factors, as well as the risks described in more detail in the section entitled “Risk Factors” in the most recent annual report of the Company on Form 10-K, as well as discussions of potential risks, uncertainties and other material factors in other documents filed by the Company with the Securities and Exchange Commission. All of these statements speak only as of the date of their publication, and the Company does not undertake to publicly update or revise forward-looking statements, whether as a result of new information, future events or otherwise.

Media contact and investor relations:

Aditxt, Inc.

[email protected]

Disclaimer

ADiTx Therapeutics Inc. published this content on 08 October 2021 and is solely responsible for the information it contains. Distributed by Public, unedited and unmodified, on 08 October 2021 09:21:09 PM UTC.

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