By John Vandermosten, CFA
READ THE FULL AZTR RESEARCH REPORT
Azitra, Inc. (NYSE:AZTR) reported first quarter 2025 ends in a Could 13th press launch sharing monetary outcomes and offering a enterprise replace. 12 months so far, the corporate has offered posters at a number of scientific conferences, entered into a purchase order settlement to lift extra capital and is waiting for a number of scientific trial associated milestones over the rest of the yr. Administration reiterates its expectation that preliminary security knowledge for ATR-12 can be reported in 2Q:25 and that topline knowledge for this Part Ib trial can be reported by yr finish 2025. The ATR-04 trial is anticipated to dose its first affected person in 2Q:25.
Operational and Monetary Outcomes
Azitra reported 1Q:25 ends in a press launch and Kind 10-Q submitting with the SEC on Could 13th. For the quarter ending March 31st, 2025 and versus the prior yr’s comparable interval, no revenues had been reported. Internet loss for the three-month interval totaled ($3.1) million or ($0.23) per share. Operational bills rose 5% as will increase basically and administrative (G&A) bills had been partially offset by declines in analysis and growth (R&D) bills. Beneath, we element monetary outcomes for 1Q:25, in comparison with the identical prior yr interval:
- Analysis and growth bills totaled $1.3 million, down from $1.5 million on account of decrease chemistry, manufacturing and management (CMC) prices and advisor prices partially offset by greater ATR-04 and ATR-01 program bills and lab provide prices;
- Normal & Administrative bills had been $1.9 million, up from $1.5 million on account of better public firm prices together with auditor, New York Inventory Alternate (NYSE) and authorized charges. Public relations bills had been additionally greater together with using enterprise consultants and restore and upkeep price;
- Internet curiosity revenue was $36,000 in comparison with $7,000;
- Different expense was ($4,000) in contrast with $22,000;
- Internet loss was ($3.1) million vs. ($2.9) million or ($0.23) and ($4.36) per share respectively;
As of March 31st, 2025, money totaled $3.2 million. This quantity compares to the $4.6 million steadiness in money held on the finish of 2024. No debt was held on the steadiness sheet. 1Q:25 money burn was ($3.1) million – roughly the identical quantity offered in 1Q:24. Money from financing was $1.7 million representing proceeds from public choices. Following the top of the reporting interval, Azitra entered into a purchase order settlement with Alumni Capital. Azitra raised $400,000 from this association in the course of the second quarter.
ATR-04
Epidermal progress issue receptor inhibitors (EGFRi) are focused most cancers therapies which have been efficient in breast, colon, lung and pancreatic most cancers. EGFR is a protein discovered on the floor of cells, and it performs a job in cell progress and division. In some cancers, resembling sure sorts of lung most cancers and colorectal most cancers, the EGFR gene is mutated or overexpressed, resulting in uncontrolled cell progress. EGFR inhibitors work by blocking the exercise of this protein, thereby slowing down or stopping most cancers cell progress.
ATR-04 is a drug product derived from an S. epidermidis pressure and is run topically. It was sourced from a wholesome volunteer and engineered to be auxotrophic to manage progress. The product inhibits IL-36γ and S. aureus each of which might trigger and exacerbate inflammatory pores and skin circumstances. ATR-04 additionally will increase human beta defensin 2 which gives antimicrobial advantages, maintains pores and skin barrier capabilities and contributes to the wound therapeutic course of by stopping infections and regulating the inflammatory response.
A Part I/II is now deliberate to start out throughout 2Q:25 that can enroll eight sufferers in a single ascending dose Part I research over 28 days. The Part II portion will goal 24 sufferers for this section of the research. A contract analysis group (CRO) is in place and 4 websites throughout the US are being recognized to be used. Azitra anticipates a speedy enrollment as these are excessive quantity most cancers facilities with many potential candidates receiving EGFRi therapy.
ATR-04 American Society of Gene and Cell Remedy (ASGCT) Presentation
Azitra offered a poster on ATR-04 entitled A Novel Staphylococcus epidermidis Compound for the Topical Therapy Epidermal Development Issue Receptor (EGFR) Inhibitor-Induced Dermal Toxicity on the American Society of Gene and Cell Remedy (ASGCT) assembly in New Orleans, Louisiana. The poster started with a background on toxicities from EGFR inhibitors then supplied an outline of the preclinical trial design and at last mentioned the upcoming Part I/II. The mechanism of motion for ATR-04 was illustrated, describing the way it decreases irritation.
Conclusions from the poster asserted that EGFRi-associated dermal toxicity is related to a big unmet want for therapy, because it results in EGFRi discontinuations and poor high quality of life in most cancers sufferers. ATR-04 demonstrated
- Proof of idea on this research with auxotroph managed by D-alanine;
- Vital discount in IL-36γ induced by erlotinib;
- Vital discount in aureus in a number of animal fashions.
The poster directed stakeholders’ consideration in direction of the upcoming Part I/II multi-dose scientific trial for EGFRi dermal toxicity that can start quickly.
Alumni Capital Share Buy Settlement
Azitra introduced a share buy settlement with Alumni Capital for as much as $20 million to fund the scientific pipeline. Azitra controls the timing of the frequent inventory gross sales and might put shares to Alumni of as much as $750,000 at its personal election and as much as $4 million on consent of the purchaser. Shares are bought at a reduction to the bottom every day quantity weighted worth within the 5 days previous the transaction. Warrants equal to 10% of the shares issued may also be granted to Alumni with an train worth of 130% of the worth paid for the frequent inventory shares.
Milestones
- Shows at BIO CEO – 1Q:25
- Presentation at Microbiome Instances Partnering Discussion board – March 2025
- Share buy settlement with Alumni Capital – April 2025
- Presentation of ATR-04 knowledge at ASCO – Could 30 to June 3, 2025
- Preliminary security knowledge from Part Ib ATR-12 – 2Q:25
- First affected person dosed with ATR-04 for EGFRi rash (Part I/II) – mid-2025
- Topline from Part Ib ATR-12 trial – 4Q:25
- ATR-01 investigational new drug (IND) submission – 4Q:25
Abstract
Azitra reported first quarter 2025 outcomes and is anticipating to each report interim security knowledge from the Part Ib research in ATR-12 for Netherton and dose its first affected person within the EGFRi rash trial earlier than the top of the second quarter. Since our final replace the corporate has offered at a number of scientific conferences together with the Microbiome Instances Partnering Discussion board and ASGCT. Azitra may also current at ASCO in lower than two weeks with a poster describing ATR-04. Along with operational achievements, the corporate has additionally raised extra capital and signed a share repurchase settlement with Alumni Capital to fund its scientific pipeline.
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