• License enables advancement of AN2-502998 (formerly known as AN15368), a boron-based small molecule therapeutic under development for the treatment of Chagas disease
  • IND-enabling preclinical studies well underway in partnership with University of Georgia Chagas expert using non dilutive funding from Wellcome

AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical company focused on developing treatments for rare, chronic, and serious infectious diseases with high unmet needs, today announced that it has received an exclusive license from the University of Georgia Research Foundation to advance the development of a boron-containing small molecule for Chagas disease. These boron-based molecules were originally discovered by researchers at Anacor Pharmaceuticals, Inc. (a wholly owned subsidiary of Pfizer) and the University of Georgia, with grant funding from Wellcome. The lead compound under this series, AN2-502998 (formerly known as AN15368), was discovered in close collaboration with Professor Rick Tarleton, Ph.D., University of Georgia, an expert in Chagas disease and Trypanosoma cruzi biology. To date, preclinical activities have been supported using non dilutive grant funding from Wellcome and are conducted in partnership with Professor Tarleton.

“AN2-502998 has the potential to be a game-changer for the treatment of individuals infected with T. cruzi, and at risk of developing clinical Chagas disease, which affects over 7 million people worldwide,” said Eric Easom, Co-Founder, President, and Chief Executive Officer of AN2 Therapeutics. “AN2-502998 is the only compound to date that demonstrates complete cures of infection in non-human primates with long-term, naturally acquired chronic infections of diverse T. cruzi genetic types. Professor Tarleton and scientists from AN2 have advanced this research, and with IND-enabling preclinical studies for AN2-502998 well underway, and this license in hand, we are excited to further develop AN2-502998 as a potential treatment for Chagas disease.”

“AN2-502998, previously published under AN15368, is the only compound to have demonstrated complete curative activity in rigorous tests in multiple species, including in non-human primates with chronic infections. Chagas disease is one of the major causes of infection-induced myocarditis worldwide and available therapies, introduced over 50 years ago, have undependable efficacy and significant side effects,” said Professor Rick Tarleton, Ph.D., Regents Professor in the Center for Tropical and Emerging Global Diseases and the Department of Cellular Biology at the University of Georgia. “We are excited to continue the highly productive collaboration that identified this compound toward eventual use in humans. I am optimistic that AN2-502998 has the potential to be a solution for those infected with T. cruzi and at risk for development of debilitating and life-threatening Chagas disease.”

About Chagas Disease

Chagas disease has been declared a Neglected Tropical Disease (NTD) by the World Health Organization (WHO). Chagas disease is caused by the parasite Trypanosoma cruzi, which spreads via a subspecies of blood-feeding insects commonly known as “kissing bugs” because they tend to bite people on the face and lips and is also transmitted congenitally from infected mothers to their babies. While the disease can progress slowly, chronic infection almost inevitably results in irreparable damage to heart and digestive system tissues. Chagas disease kills more people in Latin America than any other infectious disease – including malaria, tuberculosis, and HIV. An estimated 30% of Chagas patients develop chronic and often severe heart disease that leads to premature death. According to the World Health Organization, approximately 7 million people worldwide are estimated to be infected with the parasite T. cruzi. An increasing number of cases of Chagas are also being documented outside the normal high transmission areas, including in the United States of America and Europe.

About AN2 Therapeutics, Inc.

AN2 Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing treatments for rare, chronic, and serious infectious diseases with high unmet needs. Our initial candidate is epetraborole, which we are studying as a once-daily, oral treatment with a novel mechanism of action for patients with nontuberculous mycobacteria (NTM) lung disease, a rare, chronic, and progressive infectious disease caused by bacteria known as mycobacteria, that leads to irreversible lung damage and can be fatal. For more information, please visit our website at www.an2therapeutics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: the timing, progress, and anticipated results AN2's anticipated progress, business plans, business strategy and planned research efforts; and other statements that are not historical fact. These statements are based on AN2's current estimates, expectations, plans, objectives, and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: the continuing effects of the COVID-19 pandemic; macroeconomic conditions; early clinical, preliminary or expected results; significant adverse events, toxicities or other undesirable side effects associated with AN2's product candidate; the significant uncertainty associated with AN2's product candidate ever receiving any regulatory approvals; AN2's ability to obtain, maintain or protect intellectual property rights related to its current and future product candidates; implementation of AN2's strategic plans for its business and current and future product candidates; the sufficiency of AN2's capital resources and need for additional capital to achieve its goals; and other risks, including those described under the heading “Risk Factors” in AN2's reports filed with the SEC, including AN2’s Report on Form 10-Q for the quarter ended June 30, 2023. These filings, when available, are available on the investor relations section of our website at investor.an2therapeutics.com and on the SEC's website at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law.

References

1 Padilla, A.M. et al. Discovery of an orally active benzoxaborole prodrug effective in the treatment of Chagas disease in non-human primates. Nature Microbiology 7, 1536–1546 (2022).

COMPANY CONTACT: Lucy O. Day Chief Financial Officer l.day@an2therapeutics.com

INVESTOR AND MEDIA CONTACT: Anne Bowdidge ir@an2therapeutics.com

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