Zacks Small Cap Analysis – AZTR: New Website for ATR-04 Trial – Cyber Tech

By John Vandermosten, CFA

NYSE:AZTR

READ THE FULL AZTR RESEARCH REPORT

Azitra, Inc. (NYSE:AZTR) reported full 12 months 2025 monetary and operational ends in a February 27^thpress launch and offered a enterprise replace. Since our earlier quarterly dispatch in November, Azitra has introduced a brand new, world-class most cancers middle website for the ATR-04 program, attended a number of investor and partnering conferences, and raised further capital. The corporate additionally raised the potential of coming into into the cosmeceutical house to handle positive strains and wrinkles in its newest presentation. Different highlights for 2025 are the presentation of ATR-04 information at ASCO, the announcement of preclinical information from the ATR-01 program and a report of security information from the ATR-12 Section Ib trial.

Operational and Monetary Outcomes

Azitra reported 2025 ends in a press launch and Kind 10-Okay submitting with the SEC on February 27^th. For the 12 months ending December 31^st, 2025 and versus the prior 12 months’s comparable interval, no revenues have been reported. Internet loss for the twelve-month interval totaled ($11.0) million or ($2.25) per share.[1] Working bills have been basically flat 12 months over 12 months as barely decrease basic and administrative (G&A) bills have been offset by barely increased analysis and growth (R&D) bills. Beneath, we element 2025 monetary outcomes in comparison with the prior 12 months interval:

• No revenues have been acknowledged in contrast with $8,000 associated to the Bayer Joint Improvement Settlement;
• Analysis and growth bills elevated by 2% to $4.8 million from $4.7 million stemming from better scientific trial prices associated to the ATR-04 and ATR-01 applications. Greater laboratory provides have been partially offset by decrease payroll and advantages, decreased marketing consultant expenditures and a fall in different prices;
• Common & Administrative bills totaled $6.1 million, down 2% from $6.3 million attributable to a discount in authorized charges, salaries and advantages, itemizing prices, insurance coverage expense and different overhead. These declines have been partially offset by a rise in using enterprise consultants, public relations expenditures, software program and tools and accounting prices;
• Internet curiosity earnings was $63,000 in comparison with $11,000 with the prior 12 months dominated by curiosity earnings associated to the next money steadiness;
• Different expense was $43,000 in contrast with earnings of $2.0 million;
• Internet loss was ($11.0) million or ($2.25) per share vs. ($9.0) million or ($15.78) per share;[2]

As of December 31^st, 2025, money acknowledged on the steadiness sheet totaled $2.1 million. This compares with the $4.6 million steadiness in money on the finish of 2024. There isn’t a debt. Money burn for 2025 was $11.4 million, barely increased than the $10.6 million consumed within the prior 12 months interval. Money from financing was $8.9 million representing proceeds from public choices, a personal placement and the fairness line of credit score with Alumni Capital. This was partially offset by principal funds on finance leases. We count on that Azitra will commonly entry the fairness line to proceed funding its pipeline actions. Put up 12 months finish, Azitra raised $0.2 million with the fairness line of credit score.

ATR-12 Scientific Trials

Azitra obtained investigational new drug (IND) clearance for its Netherton syndrome candidate, ATR-12, in 2023. The corporate has since launched a Section Ib scientific trial beneath the identifier NCT06137157 and expects to enroll 12 grownup sufferers. Main endpoints will look at security and tolerability whereas secondary and exploratory endpoints will assess efficacy indicators and biomarkers. ATR-12 might be topically administered twice each day. Scientific websites at Yale College and Stanford College have been established. As of September 30^th, 2025, six sufferers have been enrolled within the ATR-12 examine; no replace on the quantity has been offered as of March 2026.

ATR-12 Trial Particulars

The examine will apply ATR-12 to lesions on one aspect of a topic’s physique and apply the automobile to the opposite. Utility of ATR-12 and the automobile might be carried out twice each day for 2 weeks. Sufferers might be randomized to obtain ATR-12 on both the fitting or left aspect. Initially, the FDA required that sufferers be dosed separately and sequentially to supply an preliminary security profile earlier than permitting parallel enrollment; nevertheless, this restriction was lifted final June. The examine requires that the younger sufferers keep on the location for 2 weeks for therapy. The trial’s main endpoint is opposed occasions at 84 days in addition to quantifying and qualifying incidence, severity, seriousness and relatedness of opposed occasions. Secondary endpoints embrace investigators’ and sufferers’ international evaluation of severity, focus of recombinant human lymphoepithelial Kazal-type associated inhibitor (rhLEKTI) within the plasma and on the pores and skin following topical software. Biomarkers might be evaluated together with KLK5, KLK7, IL-36, TARC/CCL17, trypsin-like exercise and chymotrypsin-like exercise.

June 2025 Interim Replace

An interim Section Ib replace reported security information. A June 17^thpress launch reported no extreme or severe opposed occasions. Utility website reactions have been transient and self-resolving and included gentle to average localized itch, redness, and a burning sensation with software. Such reactions have been noticed bilaterally, suggesting this isn’t a drug impact. The trial stays blinded, and information relating to the impact of the drug is just not but accessible.

ATR-04

In late February 2026, Azitra introduced that it had added MD Anderson Most cancers Middle in Houston, Texas as a scientific website for its Section I/II trial evaluating ATR-04 in EGFR inhibitor-associated pores and skin rash. Six websites at the moment are listed on the clinicaltrials.gov web site for the trial listed beneath NCT06830863 and embrace most cancers facilities and hospitals in Arkansas, Connecticut, New York, Ohio and Virginia. Enrollment for the ATR-04 trial has been gradual attributable to oncodermatologists working with oncologists to prophylactically administer antibiotics and steroids. The administration of antibiotics and steroids are exclusion standards for enrollment within the trial. There’s a sturdy need by physicians to scale back using antibiotics to keep away from broad resistance to those antibiotics. Physicians additionally acknowledge the danger of topical steroid use which might trigger thinning of the pores and skin, precipitate different sorts of rash and improve the danger of an infection. Azitra will talk the advantages of ATR-04 extra broadly all through the oncology care staff on the websites the place it’s operating the trial. Administration has additionally opened the MD Anderson website which is extra attuned to using new modalities. We count on that these modifications will enhance the enrollment charge.

ATR-01 Preclinical Knowledge

On October 20^th, Azitra introduced its upcoming presentation of ATR-01 information on the BIO-Europe convention. ATR-01 is a filaggrin-secreting pressure of S. epidermidis for ichthyosis vulgaris. Ichthyosis[3] vulgaris is an inherited pores and skin dysfunction that’s characterised by dry, scaly pores and skin that’s comparable in look to fish scales. The presentation emphasised that ATR-01 provides a constructive pharmacology profile throughout a number of preclinical fashions. In in vitro fashions, ATR-01 secreted purposeful filaggrin, as measured by keratin binding assays. Moreover, in ex vivo human pores and skin, it was discovered to ship filaggrin by means of the stratum corneum, as was measured with fluorescence immunohistochemistry. On this mannequin, ATR-01 delivered filaggrin beneath the pores and skin barrier (p < 0.05). Lastly, in an ex vivo broken pig pores and skin mannequin, ATR-01 was proven to considerably scale back transepidermal water loss in comparison with automobile management (p < 0.002). Collectively, these information show constructive pharmacological exercise and biodistribution. Azitra plans to conduct further investigational new drug (IND)-enabling research and submit an IND in 2026.

ATR-01 Cosmeceutical Derivatives

On the March BIO convention, COO Travis Whitfill launched a brand new alternative in cosmeceutical indications. The product is produced by inserting a gene fragment that encodes filaggrin into S. epidermidis to be later utilized in pores and skin purposes. The filaggrin is a byproduct of ATR-01 and should free amino acids and pure moisturizing elements that might enhance the looks of positive strains and wrinkles. One of many benefits of a cosmeceutical software is that the regulatory pathway is shorter and more cost effective. Moreover, there may be substantial demand from cosmetics corporations, particularly in Asia, for brand spanking new merchandise that present advantages. That is an early-stage initiative, however deserves additional evaluate because it evolves.

Milestones

• Share buy settlement with Alumni Capital – April 2025
• Presentation of ATR-04 information and scientific plan at ASCO – Could 30 to June 3, 2025
• Preliminary security information from Section Ib ATR-12 – June 2025
• First affected person dosed with ATR-04 for EGFRi rash (Section I/II) – August 2025
• NYSE American points deficiency letter for fairness beneath $4 million – October 2025
• Report of ATR-01 preclinical information – October 2025
• Pricing of $1.5 million personal placement – November 2025
• Discover of Acceptance of Itemizing Requirements Compliance Plan from NYSE American – December 2025
• Presentation at Biotech Showcase – January 2026
• Presentation at BIO Funding & Progress Summit – March 2026
• Particular Assembly of Shareholders – March 6^th, 2026
• ATR-04 topline announcement – Mid-year 2026
• Topline report for Section Ib ATR-12 trial – 2H:26
• ATR-01 IND submission – 4Q:26

Abstract

Azitra reported 2025 monetary and operational outcomes producing an working lack of $11.0 million and money burn of $11.4 million. Using money was funded by internet money from financing of $8.9 million from fairness line of credit score, personal placement and public providing proceeds. Enrollment for the corporate’s trials has slowed; nevertheless, motion has been taken by means of the addition of a brand new scientific trial website at MD Anderson and elevated schooling for the oncology groups that information sufferers by means of therapy. Past the work Azitra has executed with its three candidates, members of its administration staff have met with buyers and different stakeholders at a number of conferences. As we glance forward, we see a number of milestones together with topline outcomes from the 2 scientific applications and, doubtlessly, an IND submission earlier than 12 months finish. We replace our value goal to mirror present and anticipated shares excellent over the following 12 months. The results of this calculation generates a goal value of $1.70 per share.

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