AN2 Therapeutics IPO raises $69 million to advance Pfizer’s antibiotic to pivotal test

Economic concerns have halted or at least delayed many companies’ plans to go public, but one biotech braves the financial turmoil, raising $69 million from its IPO to fund a pivotal test of a new antibiotic under license from Pfizer .

When AN2 Therapeutics set financial terms for the stock offering earlier this week, the company planned to offer 4 million shares in a range of $14 to $16 each. AN2 was able to increase the size of the deal to 4.6 million shares at the median price of $15 per share. These shares began trading on the Nasdaq on Friday under the ticker symbol “ANTX”. The biotech’s stock price opened at $16.85, up 12.3% from the IPO price.

AN2’s lead drug candidate is its only drug. Eptraborole is sourced from Pfizer, which obtained the small molecule as part of its $5.2 billion acquisition of Anacor Pharmaceuticals in 2016. Key to that deal was Eucrisa, an atopic dermatitis drug that later got FDA approval but failed to meet Pfizer’s expectations. . Both Eucrisa and Epetraborole are based on boron chemistry, which has advantages in the ability to bind to and attack biological targets that are difficult to block with traditional carbon-based molecules. Eptraborole is designed to block an enzyme that is essential for bacteria, but which is not treated by other antibiotics. The approach aims to overcome the resistance that bacteria have developed to other antibiotics.

Anacor had advanced epetraborole to two Phase 2 trials with GlaxoSmithKline, a collaboration that was evaluating the drug in Gram-negative infections. But early data showed signs of clinical resistance, meaning the bacteria became less sensitive to the antibiotic. These results led to the discontinuation of these studies. But AN2 noted in its prospectus that clinical resistance is possible for all antibiotics, and the risk can be mitigated with combination therapy.

AN2 aims to test epetraborole in non-tuberculous mycobacterial lung disease (NTM), a rare, chronic and progressive infectious disease caused by mycobacteria. The disease causes irreversible lung damage that can become fatal. NTM lung disease is currently treated with combination therapy, and the AN2 noted in its prospectus that this approach is distinct from the earlier and failed monotherapy trial of epetraborole.

AN2 launched in 2019 with $12 million in Series A funding and an agreement with Brii Biosciences, which licensed development rights to the biotech’s leading antibacterial program in China. This agreement does not come with an upfront payment, but AN2 is eligible to receive up to $15 million in regulatory milestones for each licensed product and up to $150 million in commercial milestones for each product under license, according to the IPO filing. If a drug or drugs hit the Chinese market, AN2 is eligible to receive royalties from its partners who sell the products. AN2 closed an $80 million Series B funding round last year. The company’s largest shareholder is Adjuvant Global Health Technology Fund, which owns 17.2% of biotech, followed by RA Capital Management’s 14.2% stake, according to the prospectus.

With the money from the IPO, AN2 plans to spend about $65 on the clinical development of epetraborole for NTM lung diseases that have resisted first lines of treatment. A phase 1 study in renal failure is already underway; a placebo-controlled Phase 2/3 trial is expected to begin in the first half of this year. According to the prospectus, 80 patients will be enrolled in phase 2 of the study, which is not powered for statistical significance but will assess the drug’s safety, efficacy and pharmacokinetics – in combination with standard of care treatments. – compared to a placebo.

Phase 3 will enroll approximately 234 patients. AN2 is still working with the FDA to finalize the plan for this part of the study, but the company said in the IPO filing that it expects the primary focus to be to test whether the epetraborole, combined with two or more standard treatments, is superior to placebo plus standard treatments. AN2 expects to release preliminary results from the planned Phase 2 study by the middle of next year. An additional $5 million of the IPO proceeds are earmarked for the expansion of Epetraborole to other geographic markets, initially Japan. The company also plans to develop the drug for other lung disorders caused by mycobacteria.

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