Azitra, Inc. Announces Q1 2025 Results and Provides Business Updates

Rhea-AI Summary

Azitra (NYSE: AZTR) reported its Q1 2025 financial results and provided business updates. The company secured up to $20 million in funding through a partnership with Alumni Capital LP and raised an additional $2.2 million through public offerings. Key developments include acceptance of a poster presentation at ASCO 2025 for their ATR-04 program targeting EGFR inhibitor-associated rash.

The company expects initial safety data from their ATR-12 Phase 1b trial for Netherton syndrome in 1H 2025, with topline results by year-end. They also plan to begin dosing patients in a Phase 1/2 trial for ATR-04 by mid-2025. Financial results show R&D expenses of $1.3 million, G&A expenses of $1.9 million, and a net loss of $3.1 million for Q1 2025. Cash position stands at $3.2 million as of March 31, 2025.

Positive

• Secured up to $20 million funding partnership with Alumni Capital LP
• Successfully raised $2.2 million through public offerings
• ATR-12 program targeting Netherton syndrome has no current approved treatments, representing first-mover potential
• ATR-04 program addresses a significant market of 150,000 U.S. patients annually affected by EGFRi-associated rash
• R&D expenses decreased to $1.3M from $1.5M year-over-year

Negative

• Net loss increased to $3.1M from $2.9M year-over-year
• G&A expenses increased to $1.9M from $1.5M year-over-year
• Low cash position of $3.2M necessitating additional fundraising

Insights

Biotechnology Research Analyst

Azitra reports $3.1M Q1 loss while advancing clinical trials for unique dermatological therapies with secured funding to reach 2025 milestones.

Azitra's Q1 2025 results reveal a company at a pivotal stage in its clinical development journey. The financial metrics show a $3.1 million quarterly net loss, slightly widened from $2.9 million in the comparable period. While R&D expenses decreased marginally to $1.3 million from $1.5 million, G&A costs increased to $1.9 million from $1.5 million year-over-year. The company ended Q1 with $3.2 million in cash.

The cash position has been bolstered by two critical financing events: a $2.2 million raise through public offerings and a purchase agreement with Alumni Capital LP for up to $20 million. This financial reinforcement is strategically timed to support Azitra's upcoming clinical milestones, particularly for its two lead programs targeting significant unmet needs.

What makes Azitra's pipeline particularly interesting is their unique platform utilizing live biotherapeutic products (LBPs) - essentially beneficial bacteria engineered to deliver therapeutic proteins topically. Their lead candidate ATR-12 targets Netherton syndrome, a rare and severe skin condition with no FDA-approved treatments. Initial safety data is expected in 1H 2025 with topline results by year-end.

The second program, ATR-04, addresses EGFR inhibitor-associated rash, a common and often severe side effect affecting approximately 150,000 cancer patients annually in the US. This condition frequently disrupts critical cancer treatments. The program's significance is underscored by Azitra's invitation to present at ASCO 2025, indicating recognition from the oncology community.

The remainder of 2025 will be critical for validating Azitra's technology platform and potentially transforming treatment paradigms for these dermatological conditions. Investors should monitor the upcoming safety data for ATR-12 and patient dosing for ATR-04 as key inflection points that could validate this novel approach.

Financial Analyst

Azitra secured vital funding but faces cash runway concerns with Q1 burn rate of $3.1M against $3.2M cash balance despite strategic financing.

Azitra's Q1 financial results present a complex picture requiring careful investor consideration. The company reported a net loss of $3.1 million for Q1 2025, representing a 6.9% increase from the $2.9 million loss in Q1 2024. This widening loss comes despite a 13.3% reduction in R&D expenses, which decreased to $1.3 million from $1.5 million in the comparable period.

The decline in R&D spending is offset by a significant 26.7% increase in G&A expenses, which rose to $1.9 million from $1.5 million year-over-year. This administrative cost growth warrants scrutiny as the company approaches critical clinical milestones.

The most pressing financial concern is Azitra's cash position. With $3.2 million in cash and cash equivalents as of March 31, 2025, and a quarterly burn rate of approximately $3.1 million, the company faces immediate liquidity challenges. This represents a theoretical runway of just over one quarter without additional funding.

Management has taken proactive steps to address this precarious cash position through two key financing initiatives: the closing of $2.2 million in public offerings and securing a purchase agreement with Alumni Capital LP for up to $20 million. While the full $20 million commitment provides theoretical runway extension, these agreements typically come with tranched funding and specific conditions that may limit immediate access to capital.

The financing arrangements are strategically timed to support upcoming clinical milestones in 1H 2025, including initial safety data from the ATR-12 Phase 1b trial and first patient dosing in the ATR-04 Phase 1/2 trial. However, investors should carefully monitor the burn rate and terms of the Alumni Capital agreement, as clinical development programs frequently encounter delays and cost overruns that could strain the company's financial resources before reaching value-inflection points.

BRANFORD, Conn., May 13, 2025 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the quarter ended March 31, 2025, and provided a business update.

Q1 2025 and Recent Business Highlights

• Announced acceptance of poster detailing the Phase 1/2 clinical trial of the ATR-04 program in EGFR inhibitor ("EGFRi")-associated rash at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting
• Entered into Purchase Agreement for up to $20 Million in Partnership with institutional investor Alumni Capital LP, to fund clinical pipeline
• Announced closing of two public offerings raising a total of $2.2M

"The start of 2025 has been a vital period for Azitra as we build towards key milestones expected by mid-year for our first-in-class, precision, live biotherapeutic candidates designed for major undertreated dermatological diseases," said Francisco Salva, CEO of Azitra. "For ATR-12, our lead program targeting the rare, chronic and devastating Netherton syndrome, we expect to provide initial safety data from our Phase 1b trial in the first half of 2025 with topline results expected by year-end 2025. There are no approved treatments for Netherton syndrome, and we believe this novel approach has potential to be life-changing for these patients."

Salva continued: "Also by mid-2025, we look forward to dosing the first patient in our Phase 1/2 trial with our ATR-04 program, which contains a live biotherapeutic product candidate containing an isolated, naturally derived S. epidermidis strain being developed for the treatment of EGFRi-associated rash. EGFRi-associated rash is a dermatologic toxicity that often accompanies EGFRi treatments for cancer, impacting approximately 150,000 patients in the United States annually. These severe skin conditions can interfere with cancer treatment efforts, often causing significant physical and psychological discomfort for patients. Given the importance of EGFRi therapies to the cancer industry, Azitra was invited to present an update of our ATR-04 Phase 1/2 trial at ASCO 2025, which is the most prestigious cancer research conference in the world."

Salva concluded: "The remainder of 2025 is expected to be a milestone-rich period for Azitra during which we look forward to showcasing the potential of ATR-12 and ATR-04, as well as our unique, proprietary platform for delivering engineered proteins using topical live biotherapeutic products."

Pipeline and Anticipated Milestones

• 1H 2025: Initial safety data from first set of Netherton syndrome patients in the ATR-12 Phase 1b trial
• 1H 2025: First patient dosed with for EGFRi-associated rash in a Phase 1/2 trial for ATR-04
• YE 2025: Topline data of the Phase 1b trial with ATR-12 in Netherton syndrome patients

Financial Results for the Quarter Ended March 31, 2025

• Research and Development (R&D) expenses: R&D expenses for the quarter ended March 31, 2025, were $1.3 million compared to $1.5 million for the comparable period in 2024.
• General and Administrative (G&A) expenses: G&A expenses for the quarter ended March 31, 2025, were $1.9 million compared to $1.5 million for the comparable period in 2024.
• Net Loss was $3.1 million for the quarter ended March 31, 2025, compared to $2.9 million for the comparable period in 2024.
• Cash and cash equivalents: As of March 31, 2025, the Company had cash and cash equivalents of $3.2 million.

About Azitra, Inc.
Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology. The Company's lead program, ATR-12, uses an engineered strain of S. epidermidis designed to treat Netherton syndrome, a rare, chronic skin disease with no approved treatment options. Netherton syndrome may be fatal in infancy with those living beyond a year having profound lifelong challenges. The ATR-12 program includes a Phase 1b clinical trial in adult Netherton syndrome patients. ATR-04, Azitra's additional advanced program, utilizes another engineered strain of S. epidermidis for the treatment of EGFR inhibitor ("EGFRi") associated rash. Azitra has received Fast Track designation from the FDA for EGFRi associated rash, which impacts approximately 150,000 people in the U.S. Azitra has an open IND for its ATR-04 program in patients with EGFRi associated rash. The ATR-12 and ATR-04 programs were developed from Azitra's proprietary platform of engineered proteins and topical live biotherapeutic products that includes a microbial library comprised of approximately 1,500 bacterial strains. The platform is augmented by artificial intelligence and machine learning technology that analyzes, predicts, and helps screen the library of strains for drug like molecules. For more information, please visit https://azitrainc.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding the expected timing of (i) our provision of initial safety data and topline results for the phase 1b trial for our ATR-12, (ii) the abstract detailing the Phase 1/2 clinical trial for our ATR-04 program and (iii), the initiation of dosing in the Phase 1/2 clinical trial for our ATR-04 program, and statements about our clinical and preclinical programs, and corporate and clinical/preclinical strategies.

Any forward-looking statements in this press release are based on current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to that we may experience delays in the provision of initial safety data and topline results for ATR-12 or, if we do, that such data may not be favorably received, we may fail to present this abstract detailing the Phase 1/2 clinical trial or, if we are able to do so, that the abstract will be favorably received; we may experience delays in the dosing the first patient in this Phase 1/2 trial; our product candidates may not be effective; there may be delays in regulatory approval or changes in regulatory framework that are out of our control; our estimation of addressable markets of our product candidates may be inaccurate; we may fail to timely raise additional required funding; more efficient competitors or more effective competing treatment may emerge; we may be involved in disputes surrounding the use of our intellectual property crucial to our success; we may not be able to attract and retain key employees and qualified personnel; earlier study results may not be predictive of later stage study outcomes; and we are dependent on third-parties for some or all aspects of our product manufacturing, research and preclinical and clinical testing. Additional risks concerning Azitra's programs and operations are described or incorporated by reference in our annual report on Form 10-K filed with the SEC on February 24, 2025. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Contact

Norman Staskey
Chief Financial Officer
staskey@azitrainc.com

Investor Relations 
Tiberend Strategic Advisors, Inc.
Jon Nugent
205-566-3026
jnugent@tiberend.com  

Media Relations 
Tiberend Strategic Advisors, Inc.
Casey McDonald 
646-577-8520
cmcdonald@tiberend.com

 

Condensed Statement of Operations (Unaudited)
		Three months Ended March 31,
		2025				2024
Operating expenses:
General and administrative		$	1,850,138			$	1,488,527
Research and development			1,250,100				1,472,970
Total operating expenses			3,100,238				2,961,497
Loss from operations			(3,100,238)				(2,961,497)
Other income (expense):
Interest income			37,164				7,609
Interest expense			(1,293)				(915)
Change in fair value of warrants			143				28,255
Other expense			(4,121)				(6,327)
Total other income			31,893				28,622)
Net loss before income taxes			(3,068,345)				(2,932,875)
Income tax expense			-				-
Net loss		$	(3,068,345)			$	(2,932,875)
Net loss attributable to common shareholders		$	(3,068,345)				(2,932,875)
Net loss per Share, basic and diluted		$	(0.23)			$	(4.32)
Weighted average common stock outstanding, basic and diluted			13,171,516				678,885

 

Condensed Balance Sheets (Unaudited)
		March 31,				December 31,
		2025				2024
Assets
Current Assets:
Cash and cash equivalents		$	3,206,710			$	4,554,719
Other receivables			103,046				101,896
Prepaid expenses and other current assets			561,798				571,675
Total current assets		$	3,871,554			$	5,228,290
Property and equipment, net			621,012				653,957
Other assets			1,415,325				1,476,555
Total assets		$	5,907,891			$	7,358,802
Liabilities, and stockholders' equity
Current liabilities:
Accounts payable		$	558,924			$	490,255
Current financing lease liability			16,456				16,066
Current operating lease liability			237,647				255,177
Accrued expenses			467,394				614,359
Total current liabilities			1,280,421				1,375,857
Long-term financing lease liability			5,843				10,105
Long-term operating lease liability			213,765				274,161
Warrant liability			238				381
Total liabilities			1,500,267				1,660,504
Stockholders' equity
Common stock			1,498				763
Additional paid-in capital			65,040,296				63,263,360
Accumulated deficit			(60,634,170)				(57,565,825)
Total stockholders' equity			4,407,624				5,698,298
Total liabilities and stockholders' equity		$	5,907,891			$	7,358,802

 

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SOURCE Azitra, Inc.

FAQ

What were Azitra's (AZTR) key financial results for Q1 2025?

In Q1 2025, Azitra reported R&D expenses of $1.3M, G&A expenses of $1.9M, a net loss of $3.1M, and had cash and equivalents of $3.2M as of March 31, 2025.

How much funding did Azitra (AZTR) secure in Q1 2025?

Azitra secured up to $20M through a partnership with Alumni Capital LP and raised an additional $2.2M through public offerings.

What are the major clinical trial milestones expected for Azitra (AZTR) in 2025?

Azitra expects initial safety data from ATR-12 Phase 1b trial in 1H 2025, first patient dosing in ATR-04 Phase 1/2 trial by mid-2025, and topline results from ATR-12 Phase 1b trial by year-end 2025.

What conditions is Azitra (AZTR) targeting with its lead drug candidates?

Azitra is developing ATR-12 for Netherton syndrome (a rare disease with no approved treatments) and ATR-04 for EGFR inhibitor-associated rash affecting cancer patients.

What is the market size for Azitra's (AZTR) ATR-04 treatment?

ATR-04 targets EGFRi-associated rash, which affects approximately 150,000 patients annually in the United States.