Azitra Inc. (NYSE American: AZTR), a trailblazer in precision dermatology, today announced its financial outcomes for the year ending December 31, 2023, alongside a comprehensive business update.

Financial Highlights:

• The company celebrated a successful initial public offering, amassing $7.5 million.
• Service revenue saw an increase from $0.3 million in 2022 to $0.7 million.
• R&D expenses decreased to $3.8 million from $6.1 million.
• G&A expenses rose to $4.5 million.
• The year concluded with a net loss of $11.3 million.
• Cash reserves stood at $1.8 million, excluding $4.4 million from a recent follow-on offering.

Operational Milestones:

• IND clearance was secured for ATR-12, targeting Netherton syndrome, with a Phase 1b trial underway.
• The company fortified its intellectual property with a U.S. patent for treating skin diseases.
• Travis Whitfill ascended as COO, with Barbara Ryan and John Schroer joining the board.

Pipeline Prospects:

• ATR-12 is poised to address the unmet needs of over 20,000 Netherton syndrome patients, eyeing peak sales of approximately $250 million.
• ATR-04, aimed at combating chemotherapy-induced rashes, serves a potential market of 150,000 U.S. patients, with sales projected to surpass $1 billion.
• The Bayer Joint Development Agreement promises to tap into a market of 230 million individuals with eczema-prone skin.

Azitra’s strategic advancements and robust pipeline position the company as a significant player in the dermatological landscape, promising a future of innovative treatments for skin conditions.

“Throughout 2023 and now into 2024, Azitra’s unwavering commitment to combatting multiple serious skin conditions and diseases has propelled the company towards fundamental near-term catalysts,” said Francisco Salva, CEO of Azitra.

“For our leading program, ATR-12 targeting Netherton’s syndrome, we’ve transitioned into the operational phase for our Phase 1b clinical trial. With a CRO onboard and discussions finalized with lead sites to activate the program and recruit ~12 patients, we’re poised to execute on a series of potentially high-impact catalysts. Moving forward, we’re focused on executing on key value-driving milestones, including getting the first patient enrolled, and a release of initial clinical data.”

“Next, for our ATR-04 program targeting EGFRi-associated rash, we intend to submit an IND for a Phase 1b clinical trial in cancer patients undergoing EGFRi targeted therapy in mid-2024. Subject to FDA clearance of our IND, we plan to initiate a Phase 1b clinical trial by year end.

“Additionally, regarding our Joint Development Agreement with Bayer, we are pleased with the recent progress of our collaboration and Bayer’s re-affirmed commitment to an execution of a license agreement.”

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