On August 12, 2024 Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported financial results for the three months ended June 30, 2024, and provided a business update (Press release, Azitra, AUG 12, 2024, View Source [SID1234645748]).
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Q2 2024 and Recent Business Highlights
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Completed a follow-on offering of $10 million in gross proceeds expected to provide cash runway into 2025. With the recent financing, the company anticipates announcing multiple clinical milestones
● Strengthened global intellectual property portfolio with newly granted and allowed patents
● Exhibited positive preclinical data from ATR-04 at the Society of Investigative Dermatology Annual Meeting
● Presented positive preclinical data of ATR-12 and clinical design in Netherton Syndrome at the ASGCT (Free ASGCT Whitepaper) Annual Meeting
● Opened a Phase 1b clinical trial for ATR-12 for recruitment
Francisco Salva, CEO of Azitra commented:
"Azitra is poised to achieve significant milestones in the second half of 2024 and beyond, propelling our pipeline forward. In Q3 2024, we expect to dose the first Netherton syndrome patient with ATR-12. Additionally, we anticipate filing and clearing an Investigational New Drug (IND) application for ATR-04, targeting epidermal growth factor receptor inhibitor (EGFRi) rash, a condition with high unmet need. This milestone will expand our clinical pipeline to two clinical-stage programs.
Approximately year-end 2024, we anticipate reporting initial safety data from the ATR-12 Phase 1b trial in Netherton syndrome patients and providing an update on our Bayer license agreement. We expect to initiate a first-in-human clinical trial with ATR-04 for EGFRi rash this fall.
Looking ahead to mid-2025, we eagerly anticipate reporting topline data from the ATR-12 Phase 1b trial, a defining moment as we aim to demonstrate biological proof of concept of our innovative approach in addressing this severe, rare skin disorder.
With a clear roadmap, strong financial position, and dedicated team, Azitra is well-positioned to execute these milestones, deliver transformative therapies to patients in need, and ultimately maximize shareholder value."
Pipeline and Upcoming Milestones
○ Q3 2024: First Netherton syndrome patient dosed with ATR-12
○ Q3 2024: New investigational new drug (IND) application filed and cleared with the FDA for a Phase 1/2 clinical study of ATR-04 in patients with dermal toxicity undergoing treatment with EGFR inhibitors ("EGFRi rash")
○ YE 2024: Initial safety data from first set of Netherton syndrome patients in the Phase 1b trial
○ YE 2024: First patient dosed with ATR-04 for EGFRi rash by year end 2024
○ YE 2024: Bayer collaboration continues with update on license agreement expected by year end
○ Mid 2025: Topline data of the Phase 1b trial with ATR-12 in Netherton syndrome patients expected
Financial Results for the Three Months Ended June 30, 2024
● Service Revenue – Related Party: The Company generated $7,500 service revenue during the quarter ended June 30, 2024, compared to $172,000 for the comparable period in 2023.
● Research and Development (R&D) expenses: R&D expenses for the quarter ended June 30, 2024, were $1.1 million compared to $0.8 million for the comparable period in 2023.
● General and Administrative (G&A) expenses: G&A expenses for the quarter ended June 30, 2024, were $1.5 million compared to $0.8 million for the comparable period in 2023.
● Net Loss was $2.6 million for the quarter ended June 30, 2024, compared to $5.1 million for the comparable period in 2023.
● Cash and cash equivalents: As of June 30, 2024, the Company had cash and cash equivalents of $0.8 million.
About ATR-12
ATR-12 (also known as ATR12-351) is an engineered strain of S. epidermidis that expresses a fragment of human lympho-epithelial Kazal-type-related inhibitor (LEKTI) protein, which is missing in patients with Netherton syndrome, a chronic and sometimes fatal disease of the skin estimated to affect approximately 20,000 patients globally. ATR-12 has been engineered to deliver missing LEKTI protein when applied topically to Netherton syndrome patients. Azitra has an open IND for a Phase 1b clinical trial that is actively recruiting adult Netherton syndrome patients (NCT06137157). Azitra has identified Netherton syndrome patients for enrollment in its 12-patient, Phase 1b clinical trial, which will assess safety, tolerability, and efficacy endpoints.
About ATR-04
ATR-04 is a live biotherapeutic product candidate including an isolated, naturally derived S. epidermidis strain that was engineered to be safer by deleting an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR-04. ATR-04 is in development for EGFR inhibitor ("EGFRi") associated rash, which is caused by the suppression of skin immunity by EGFRis and subsequent inflammation and often elevated levels of IL-36γ and S. aureus. There are approximately 150,000 patients suffering from EGFRi rash in the United States. Azitra plans to initiate a Phase 1/2 clinical study in patients undergoing EGFRi rash by year end 2024.