Azitra, Inc. Reports Q1 2024 Financial Results and Business Updates

Azitra, Inc., a clinical-stage biopharmaceutical company specializing in precision dermatology, has reported its financial results for the quarter ending March 31, 2024, along with updates on its business operations. The key highlights for Q1 2024 and recent business developments include significant advancements in their clinical programs and strategic initiatives.

Azitra’s lead program, ATR-12, has made considerable progress in its Phase 1b trial by activating clinical sites and receiving central IRB approval. The company has also identified initial subjects with Netherton syndrome for dosing. The primary goal of this trial is to assess the safety and tolerability of ATR-12, with efficacy endpoints also being evaluated. The company expects to announce initial safety data by the end of the year.

Furthermore, Azitra successfully completed a pre-IND meeting with the FDA for ATR-04, aimed at addressing EGFR inhibitor-induced rash, a common and severe side effect in cancer patients. The Company plans to submit an IND by mid-2024, with the goal of commencing a Phase 1b trial by year-end, contingent on FDA clearance.

Azitra also presented new preclinical data at the American Society of Gene and Cell Therapy (ASGCT) related to ATR-12. The data demonstrated that the topical application of ATR-12 to ex vivo human skin showed a potential for superior LEKTI delivery compared to traditional methods. Additionally, preclinical data suggested that ATR-12 could significantly reduce IL-36γ, a pro-inflammatory cytokine linked to Netherton syndrome.

A recent public offering in February 2024 raised $5.0 million in gross proceeds, intended to support the advancement of Azitra's clinical programs. The company also secured a U.S. patent for treating skin diseases using recombinant microorganisms, enhancing its intellectual property portfolio.

In collaboration with Bayer, Azitra is advancing a Joint Development Agreement focused on developing products for eczema-prone skin using S. epidermidis strains. Discussions are ongoing for a potential license agreement with Bayer.

Financially, Azitra reported no service revenue for the quarter ended March 31, 2024, in contrast to $113,300 for the same period in 2023. Research and development expenses rose to $1.5 million from $0.8 million, while general and administrative expenses also increased to $1.5 million from $0.8 million in the comparable period. The net loss for Q1 2024 was $2.9 million, slightly higher than the $2.5 million loss reported for Q1 2023. As of March 31, 2024, Azitra had cash and cash equivalents totaling $3.0 million.

Azitra’s pipeline includes ATR-12 for Netherton syndrome, with an estimated peak sales opportunity of around $250 million, and ATR-04 for EGFR inhibitor-induced rash, with a potential market exceeding $1 billion. Upcoming milestones for ATR-12 include the publication of preclinical data at the ASGCT Annual Meeting on May 10, 2024, and the SID Annual Meeting on May 17, 2024. The first patient dosing in the 12-patient clinical trial is anticipated, with initial safety data expected later in the year.

For ATR-04, preclinical data will be presented at the ASCO Annual Meeting on May 23, 2024, with an IND submission planned for mid-2024 and first patient dosing expected by late 2024 or early 2025.

Azitra is optimistic about its future, citing a robust pipeline, strategic partnerships, and significant upcoming milestones that could revolutionize treatments for severe skin conditions and generate substantial shareholder value.