Pfizer executives think they’re well-timed to wait after buying Anacor Pharmaceuticals and its atopic dermatitis drug candidate for $5.2 billion. The product was approved by the FDA in 2016, but stiff competition kept it from living up to lofty expectations. Pfizer has since attempted to monetize other Anacor assets, one of which is now in the hands of AN2 Therapeutics. The small molecule holds promise for pivotal testing in a rare lung disease, and AN2 plans to fund clinical studies through the launch.
AN2 submitted preliminary application IPO paperwork Meeting with securities regulators later Friday. The Menlo Park, Calif.-based company has not yet determined the transaction size or any pricing terms for the proposed stock offering. AN2 has applied to list on the Nasdaq under the ticker symbol “ANTX”.
The biotech company said in its IPO filing that now AN2 and previous Anacor’s research is based on boron chemistry. The ability of the fifth element of the periodic table to bind to biological targets is a key feature that has the potential to address targets that are difficult to treat with traditional carbon-based molecular drugs, AN2 said. Because boron-based drugs are selective for their biological targets, the risk of off-target effects is minimized. The element can also “tune” the properties of the drug.
Before Anacor’s atopic dermatitis drug (now sold under the name “Eucrisa”) crisaborole, which was the main target of Pfizer’s acquisition, the biotech had previously won FDA approval for a different boron-based drug. Tavaborole (marketed by Pfizer as Kerydin) is an antifungal agent that blocks protein synthesis. AN2’s drug candidate, epetraborole, is a boron-containing tavaborole analog designed to target protein synthesis in bacteria. The primary disease target of AN2 drugs is non-tuberculous mycobacterial (NTM) lung disease, a rare chronic progressive infectious disease. This disease caused by mycobacteria can cause irreversible lung damage and can even be fatal.
The company said the AN2 drug has broad activity against mycobacteria. AN2 is developing the drug, an oral product designed for once-daily administration, for the treatment of Mycobacterium avium complex (MAC) lung disease, the most common type of NTM lung disease.
An FDA-approved treatment is available to patients with difficult-to-treat cases of MAC lung disease.Insmed Approval 2018 for Arikayce, an inhaled formulation of the injectable antibiotic amikacin. But AN2 noted in its IPO filing that clinical trial results showed that Arikayce, in combination with standard-of-care antibiotics, resulted in remission of MAC infections in only 29 percent of patients, leaving plenty of room for alternative treatment options. There are also tolerability and safety concerns with the Insmed drug, which are outlined in a boxed warning on its label.
“We believe that improving the treatment of NTM lung disease will require an effective, safe and well-tolerated antibiotic with a novel mechanism of action unaffected by existing antibiotic resistance and in a convenient once-daily oral dose, ” AN2 said in the IPO filing.
AN2 is led by President and CEO Eric Easom, the former vice president of Neglected Diseases at Anacor.According to the prospectus of Biotechnology, the company was established in 2017 and was officially established Launched in 2019 Backed by $12 million in Series A funding. At the time, AN2 also announced a partnership with Brii Biosciences, which acquired the rights to develop the biotech’s leading antibacterial program in China. AN2 closed one $80 million in Series B financing Round 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.
AN2 reported a cash position of $62 million at the end of last year. Combined with the IPO proceeds, the company plans to use its cash for the clinical development of epetraborole, including an ongoing Phase 1 renal impairment study and a planned Phase 2/3 clinical trial. The company said pivotal studies are expected to begin in the first half of this year; preliminary data from the Phase 2 portion is expected in mid-2023. AN2 also plans to use some of the cash to develop its lead medicine for other geographic markets, with an initial focus on Japan, as well as to develop molecules for other pulmonary indications.
The timing of AN2’s IPO or any stock offering is uncertain. Financial markets have been hit by worries about inflation and stock volatility. Any company planning to sell stock must now consider Russia’s invasion of Ukraine and the impact the conflict will have on a global scale, Bill Smith, co-founder and CEO of IPO research firm Renaissance Capital, wrote in its weekly IPO update.
“Fear and uncertainty about the war in Ukraine overshadowed a strong U.S. jobs report, and growth stocks took a hit,” Smith said. “This means the IPO window will remain closed. Any investor willing to buy would rather buy their favorite IPO at a 50% drop from the recent high than spend time researching new deals.”
London-listed Okyo Pharma files for U.S. IPO
good pharmacy archive Paperwork with U.S. securities regulators regarding the IPO of American Depositary Shares. UK-based Okyo has been trading on the London Stock Exchange under the ticker “OKYO” since 2018. The biotech did not say how many shares it plans to issue in its U.S. securities offering, nor did it disclose any pricing details. Okyo has applied to list on the Nasdaq under the same ticker as its London listing.
Okyo is designed to treat eye diseases by targeting G protein-coupled receptors (GPCRs), membrane receptors found throughout the body that are key to a variety of biological functions. Okyo’s lead therapeutic candidate, OK-101, is a peptide drug designed to target chemokine-like receptor 1, a GPCR important for how inflammatory eye disease develops. This GPCR target can be activated and regulated by chemerin, a protein found in the body. But chemerin has a short half-life. OK-101 is a chemerin analog designed to be more stable. Okyo’s drug candidates are based on technology licensed from On Target Therapeutics.
The primary disease target of OK-101 is dry eye. Okyo said in the IPO filing that OK-101 also has potential applications in the treatment of ocular neuralgia, ocular inflammation and allergic conjunctivitis.inside prospectus, Okyo said it plans to use the cash from its U.S. IPO to advance OK-101 to submit an investigational new drug application and clinical development for dry eye disease. The application is expected to be submitted to the FDA in the third or fourth quarter of this year, the filing said.
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