Economic concerns have halted or at least delayed plans for many companies to go public, but one biotech is risking a financial turmoil by raising $69 million from an IPO to fund a pivotal trial of a new antibiotic licensed by Pfizer.
When AN2 is treated Set financial terms For the stock offering earlier this week, the company plans to issue 4 million shares priced between $14 and $16 each. AN2 was able to expand the deal size to 4.6 million shares, Pricing Midpoint at $15 a share Thursday night. The shares began trading on the Nasdaq on Friday under the ticker “ANTX.” Shares of the biotech opened at $16.85, up 12.3% from its IPO price.
AN2’s lead drug candidate is its only drug. Epetraborole is from Pfizer, which has small molecules as part of it Acquired Anacor Pharmaceuticals for $5.2 billion 2016. A key part of the deal was Eucrisa, an atopic dermatitis drug that later won FDA approval but fell short of Pfizer’s blockbuster expectations. Both Eucrisa and Epetraborole are based on boron chemistry, which has advantages in the ability to bind and address biological targets that are difficult to block using traditional carbon-based molecules. Epetraborole is designed to block an enzyme vital to bacteria that other antibiotics cannot. The method is designed to overcome resistance developed by bacteria to other antibiotics.
Anacor has advanced epetraborole into two Phase 2 tests with GlaxoSmithKline, a collaboration that is evaluating the drug in Gram-negative infections. But early data showed signs of clinical resistance, meaning bacteria are less sensitive to antibiotics. These results led to the discontinuation of these studies. But AN2 noted in its prospectus that clinical resistance can develop with all antibiotics and that this risk can be mitigated with combination therapy.
AN2 is designed to test the role of epetraborole in non-tuberculous mycobacterial (NTM) lung disease, a rare, chronic and progressive infectious disease caused by mycobacteria. This condition can cause irreversible lung damage that can even be fatal. NTM lung disease is currently treated with combination therapy, an approach that AN2 notes in its prospectus that differs from an earlier and failed trial of epipaborole monotherapy.
AN2 roll out In 2019, it secured a $12 million Series A financing and entered into an agreement with Brii Biosciences, which acquired the rights to develop the biotech’s leading antimicrobial program in China. The deal comes with no upfront payment, but AN2 is eligible to receive up to $15 million in regulatory milestones per licensed product and up to $150 million in commercial milestones per licensed product, according to IPO filings. If one or more drugs enter the Chinese market, AN2 is eligible to receive royalties from product sales by its partners. AN2 closed one $80 million Series B financing last year. The company’s largest shareholder is the Adjuvant Global Health Technology Fund, which holds a 17.2% stake in the biotech company, followed by RA Capital Management with a 14.2% stake, according to the prospectus.
With the IPO funding, AN2 plans to spend about $65 on the clinical development of epetraborole, a treatment for NTM lung disease resistant to earlier treatments. A Phase 1 renal impairment study is already underway; a placebo-controlled Phase 2/3 trial will begin in the first half of this year. According to the prospectus, 80 patients will be enrolled in the Phase 2 portion of the study, which is not statistically significant but will be combined with standard-of-care treatment to assess the drug’s safety, efficacy and pharmacokinetics. placebo.
The Phase 3 portion will enroll approximately 234 patients. AN2 is still working with the FDA to finalize plans for this part of the study, but the company said in its IPO filing that it expects the primary goal will be to test whether epetraborole in combination with two or more standard treatments is better than placebo plus standard care. AN2 expects to publish preliminary results from the second phase of the study in the middle of next year. Another $5 million in IPO proceeds was earmarked for expanding epetraborole into other geographic markets, initially Japan. The company also plans to develop drugs to treat other lung diseases caused by mycobacteria.
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