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Antios Therapeutics Announces Notice of Allowance for U.S. Patent on Phosphoramidates for the Treatment of Hepatitis B Virus

DOYLESTOWN, PA, April 26, 2022 – Antios Therapeutics, Inc. (Antios), a clinical-stage biopharmaceutical company developing innovative therapies to treat and cure chronic hepatitis B virus (HBV), today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 16/312,756, titled, “Phosphoramidates for the Treatment of Hepatitis B Virus,” covering compositions containing Antios’ novel Active Site Polymerase Inhibitor Nucleotide (ASPIN), ATI-2173, in combination with other therapies and mechanisms of action.

“The USPTO’s Notice of Allowance permits us to continue developing potentially transformative combinations with our promising investigational liver-targeted, non-chain terminating, HBV polymerase inhibitor,” said Antios Chief Executive Officer, Greg Mayes. “This patent provides further validation of the novel ASPIN approach in developing innovative therapies as we pursue combinations in our mission to develop a functional cure for the up to 300 million people living with chronic HBV.”

ATI-2173 is the only ASPIN for HBV in clinical development, and its mechanism of action is designed to be complementary to other approaches that also seek to achieve a functional cure. Pre-clinical data to date for ATI-2173, alone or combined with tenofovir disoproxil fumarate (TDF), indicate the potential for sustained HBV DNA suppression off-treatment, unique among approved nucleos(t)ides and investigational anti-HBV therapies. In 2021, Antios acquired a series of fourth generation capsid assembly modulators (CAMs) being developed for the treatment of HBV. Antios’ pipeline reflects its commitment to the HBV space and community through differentiated molecules and mechanisms of action.

About ATI-2173

ATI-2173, Antios Therapeutics’ lead once-daily, oral drug candidate for treating HBV, is an investigational phosphoramidate prodrug of clevudine monophosphate. ATI-2173 has the potential, if approved, to become the cornerstone of a curative HBV regimen. It is the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) for HBV in clinical development, and its mechanism of action is designed to be complementary to other approaches that also seek to achieve a functional cure. ATI-2173 is currently in Phase 2a clinical development. The SAVE-1 (Sustained Anti-Viral Efficacy) trial is an ongoing, double-blind, randomized, placebo-controlled study of 30 patients designed to assess the safety and efficacy of 25 and 50 mg doses of ATI-2173 daily for 90 days in combination with tenofovir disoproxil fumarate (TDF), compared with TDF plus placebo (control) in chronic HBV-infected subjects, with a cohort of HDV coinfected subjects.

About HBV

Hepatitis B is a potentially life-threatening liver infection caused by HBV. HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection represents a significant unmet medical need. The World Health Organization estimates that up to 300 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately 2 million people in the United States suffer from chronic HBV infection. Approximately 900,000 people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options.

About Antios Therapeutics, Inc.

Antios Therapeutics is a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure viral diseases. Its lead drug candidate ATI-2173 – the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) for HBV in clinical development – has the potential, if approved, to become the cornerstone of a curative therapeutic regimen for chronic HBV. Antios is also developing a novel series of fourth-generation capsid assembly modulators (CAMs) to further expand Antios’ portfolio of differentiated molecules in the HBV space. HBV is a major unmet global health problem affecting up to 300 million people worldwide, more than hepatitis C and HIV combined. For more information, please visit www.antiostherapeutics.com.

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