Azitra, Inc. Shares Business Progress and Financial Insights

Azitra, Inc. Reports Third Quarter 2024 Financial Results

Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company dedicated to innovative therapies in precision dermatology, has shared its financial performance for the third quarter of 2024, along with significant updates about its business activities.

Key Developments in Q3 2024

During the third quarter, Azitra has made significant strides:

• Successfully completed a follow-on offering achieving $10 million in gross proceeds.
• Dosed its first Netherton syndrome patient with ATR-12.
• Submitted an Investigational New Drug (IND) application and received FDA clearance for ATR-04, aimed at treating skin rashes caused by EGFR inhibitors.
• Received Fast Track designation from the FDA for ATR-04.
• Presented promising preclinical results and a detailed clinical plan for a Phase 1/2 study of ATR-04 at a noteworthy dermatology congress.
• Enhanced its intellectual property portfolio through the granting of new patents.

CEO Comments

Francisco Salva, CEO of Azitra, expressed enthusiasm about the progress made in Q3 of 2024, particularly lauding the dosing of the first ATR-12 patient in their Netherton syndrome trial. He emphasized completing a substantial funding round to fuel further research.

Pipelines and Future Milestones

Looking ahead, Azitra has scheduled several important milestones for 2025:

• Q1 2025: Initial safety data from the first group of Netherton syndrome patients in the Phase 1b trial.
• Q1 2025: First patient to be dosed with ATR-04 in an ongoing Phase 1/2 trial related to EGFRi rash.
• End of 2025: Topline data anticipated from the Phase 1b trials of ATR-12 among Netherton syndrome patients.

Financial Insights for the Third Quarter

When examining financial metrics, Azitra reported a service revenue of $0 for the quarter. Comparatively, the previous year recorded $310,700 in related party service revenue. Research and development expenses are noted at $1.0 million, rising from $0.5 million year-over-year.

General and administrative expenses also saw a slight increase, recorded at $1.9 million compared to $1.8 million in the preceding year. Overall, Azitra's net loss was reported at $1.0 million, significantly improved from a $1.9 million loss in the same quarter last year. The company concluded the quarter with $7.3 million in cash and cash equivalents.

About ATR-12

ATR-12, also referred to as ATR12-351, is a specially engineered strain of S. epidermidis designed to deliver the human lympho-epithelial Kazal-type-related inhibitor (LEKTI) protein, which is deficient in those with Netherton syndrome. This unique innovative approach is directed towards approximately 20,000 patients worldwide suffering from this chronic skin condition.

About ATR-04

On the other hand, ATR-04 is a live biotherapeutic in development targeting the rash associated with EGFR inhibitors. It consists of a naturally derived strain of S. epidermidis modified for safety and efficacy. Azitra is preparing to commence a Phase 1/2 clinical study for this product candidate, which could benefit about 150,000 patients in the United States alone.

About Azitra, Inc.

Azitra, Inc. focuses on developing transformative, precision dermatology therapies through engineered proteins and topical live biotherapeutics. By leveraging a unique microbial library, the company is set to evaluate the therapeutic potential of various bacterial strains supported by machine learning technologies.

Frequently Asked Questions

What highlight has Azitra achieved recently?

Azitra has dosed its first patient in the ATR-12 trial for Netherton syndrome, marking a significant milestone for the company.

What is the company's current financial position?

Azitra reported a net loss of $1.0 million for Q3 2024, with cash and cash equivalents totaling $7.3 million.

What is ATR-12?

ATR-12 is a therapeutic engineered strain of S. epidermidis aimed at delivering LEKTI protein to treat Netherton syndrome.

When will Azitra release initial safety data for its trials?

Initial safety data is expected in Q1 2025 from the Phase 1b trial involving Netherton syndrome patients.

What are the future plans for ATR-04?

Azitra plans to initiate a Phase 1/2 clinical study for ATR-04 targeting EGFRi-associated rashes in early 2025.

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