ATR-01

Its public offering—which closed yesterday—will see Azitra sell 1.5 million shares of common stock at $5 a pop. Bayer-partnered Azitra will use the proceeds of a $7.5 million IPO to push its engineered bacterial treatments for skin conditions into the clinic. The Connecticut-based biotech’s pipeline is based on a library of about 1,500 bacterial strains that the company has screened for potential therapeutic properties. So far, Azitra said it has identified 60 bacterial species that it believes could be engineered into treatments with “significant therapeutic effect.” Chief among them is ATR-12, a genetically modified strain of the bacterium Staphylococcus epidermidis that the biotech had planned to enter into a phase 1b trial for Netherton syndrome—a disorder of the skin, hair and immune system—in the first half of the year, according to a Securities and Exchange Commission filing. While the condition is rare, Azitra said estimates of the syndrome affecting just 1 in 100,000 people “may be underestimated due to misdiagnosis caused by similarities to other skin diseases.” With ATR-12 having received a pediatric rare disease tag from the FDA, the biotech expects to report initial results from the phase 1 trial in the first half of 2024. Azitra has two more wholly owned assets gearing up for human trials. ATR-04 is another engineered S. epidermidis strain designed to treat patients with a papulopustular rash that has been caused by epidermal growth factor receptor inhibitor targeted therapy for cancer. The company hopes to launch an early-stage trial in the first half of next year, subject to FDA go-ahead. Then there’s ATR-01, an engineered recombinant human filaggrin protein designed to treat a scaly skin disease called ichthyosis vulgaris. The biotech is aiming for human trials to begin in late 2024. There are also two strains of bacterial microbes selected from Azitra’s library by Bayer as part of a collaboration initiated in 2019. The German healthcare giant has the exclusive option to license the strains as potential over-the-counter cosmetic products and also has the option to expand the collaboration to cover another four strains. Bayer demonstrated its commitment to the biotech by purchasing $8 million of stock as part of a series B funding round in 2020. Azitra has boosted its ability to engineer the bacterial strains from its library courtesy of an exclusive license from the Fred Hutchinson Cancer Center to use its SyngenicDNA Minicircle Plasmid technology. This allows the biotech to “build plasmids in order to make genetic transformations that have never been previously achieved,” it said in the filing. While this tech wasn’t required to produce the biotech’s current crop of near-clinical candidates, Azitra said it will “open up the ability to make genetic transformations of an expanded universe of microbial species.” The public offering—which closed yesterday—sees Azitra sell 1.5 million shares of common stock at $5 a pop. Underwriters will also have a 45-day option to purchase up to an additional 225,000 shares. The company said it plans to use the net proceeds to fund its clinical trials as well as for product development, R&D, clinical manufacturing and various corporate costs. Azitra is headed up by CEO Francisco Salva, who previously co-founded Acerta Pharma, a blood cancer biotech that was acquired by AstraZeneca in 2016.