Azitra, Inc. Announces Q2 2025 Results and Provides Business Updates
Rhea-AI Summary
Azitra (NYSE American: AZTR), a clinical-stage biopharmaceutical company, reported Q2 2025 financial results and business updates. The company achieved 50% enrollment in Phase 1b trial of ATR-12 for Netherton syndrome, showing promising safety data in the first five patients. Additionally, Azitra secured a $20 million equity line of credit from Alumni Capital LP.
The company's pipeline includes ATR-04, targeting EGFRi-associated rash affecting approximately 150,000 US patients annually. Key upcoming milestones include first patient dosing in ATR-04's Phase 1/2 trial in Q3 2025 and ATR-12's Phase 1b topline data in Q1 2026. Financial results show R&D expenses of $1.4 million, G&A expenses of $1.5 million, and a net loss of $2.9 million, with cash position at $1.0 million.
Positive
- Secured $20 million equity line of credit for clinical pipeline funding
- Achieved 50% enrollment in Phase 1b trial of ATR-12 with promising safety profile
- Targeting large market opportunity with ATR-04 (150,000 US patients annually)
- Clear pipeline milestones set for Q3 2025 and Q1 2026
Negative
- Increased net loss to $2.9 million from $2.6 million year-over-year
- Low cash position of $1.0 million as of June 30, 2025
- Higher R&D expenses at $1.4 million compared to $1.1 million in previous year
News Market Reaction 8 Alerts
On the day this news was published, AZTR declined 7.61%, reflecting a notable negative market reaction. Our momentum scanner triggered 8 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $271K from the company's valuation, bringing the market cap to $3M at that time.
Data tracked by StockTitan Argus on the day of publication.
Q2 2025 and Recent Business Highlights
- Announced initial safety results and
50% enrollment of the Phase 1b clinical trial of the ATR-12 program in Netherton syndrome, demonstrating a promising safety profile
- 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 a purchase agreement for up to
$20 million
"The first half of 2025 was a vital period for Azitra as we hit a key milestone in 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 announced promising safety data in the first five patients dosed with ATR12-351, and we believe this novel approach has potential to be life-changing for these patients. Netherton syndrome has a high unmet need with no approved treatment options."
Mr. Salva continued: "We also announced the design of our Phase 1/2 trial with our ATR-04 program at ASCO, which is investigating 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
Mr. Salva concluded: "The remainder of 2025 is anticipated 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
- Q3 2025: First patient to be dosed with for EGFRi-associated rash in a Phase 1/2 trial for ATR-04
- Q1 2026: Topline data of the Phase 1b trial with ATR-12 in Netherton syndrome patients
Financial Results for the Quarter Ended June 30, 2025
- Research and Development (R&D) expenses: R&D expenses for the quarter ended June 30, 2025, were
$1.4 million $1.1 million - General and Administrative (G&A) expenses: G&A expenses for the quarter ended June 30, 2025, were
$1.5 million $1.5 million - Net Loss was
$2.9 million $2.6 million - Cash and cash equivalents: As of June 30, 2025, Azitra had cash and cash equivalents of
$1.0 million
About Azitra, Inc.
Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology. Azitra'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 adults with Netherton syndrome. ATR-04, Azitra's additional clinical program, utilizes another engineered strain of S. epidermidis for the treatment of EGFR inhibitor ("EGFRi") associated skin toxicity; a Phase 1/2 clinical trial has been initiated for this program. Azitra has received Fast Track designation from the United States Food and Drug Administration for this program to treat EGFRi associated rash, which impacts approximately 150,000 people in
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, (iii) the initiation of dosing in the Phase 1/2 clinical trial for our ATR-04 program, and (iv) 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 United States Securities and Exchange Commission 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 June 30, | ||||||||
2025 | 2024 | |||||||
Service revenue – related party | $ | - | $ | 7,500 | ||||
Total revenue | - | 7,500 | ||||||
Operating expenses: | ||||||||
General and administrative | 1,469,513 | 1,549,228 | ||||||
Research and development | 1,401,839 | 1,118,552 | ||||||
Total operating expenses | 2,871,352 | 2,667,780 | ||||||
Loss from operations | (2,871,352) | (2,660,280) | ||||||
Other income (expense): | ||||||||
Interest income | 15,461 | 16,268 | ||||||
Interest expense | (468) | (1,782) | ||||||
Change in fair value of warrants | 54 | 4,272 | ||||||
Other expense | (32,688) | 9,529 | ||||||
Total other income (expense) | (17,641) | 28,287 | ||||||
Net loss before income taxes | (2,888,993) | (2,631,993) | ||||||
Income tax expense | - | - | ||||||
Net loss | $ | (2,888,993) | $ | (2,631,993) | ||||
Net loss attributable to common shareholders | $ | (2,888,993) | (2,631,993) | |||||
Net loss per Share, basic and diluted | $ | (0.18) | $ | (2.74) | ||||
Weighted average common stock outstanding, basic and diluted | 16,279,574 | 960,146 | ||||||
Condensed Balance Sheets (Unaudited) | ||||||||
June 30, | December 31, | |||||||
2025 | 2024 | |||||||
Assets | ||||||||
Current Assets: | ||||||||
Cash and cash equivalents | $ | 1,045,730 | $ | 4,554,719 | ||||
Other receivables | 78,407 | 101,896 | ||||||
Prepaid expenses and other current assets | 675,553 | 571,675 | ||||||
Total current assets | $ | 1,799,690 | $ | 5,228,290 | ||||
Property and equipment, net | 601,504 | 653,957 | ||||||
Other assets | 1,554,828 | 1,476,555 | ||||||
Total assets | $ | 3,956,022 | $ | 7,358,802 | ||||
Liabilities, and stockholders' equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 635,842 | $ | 490,255 | ||||
Current financing lease liability | 16,854 | 16,066 | ||||||
Current operating lease liability | 286,499 | 255,177 | ||||||
Accrued expenses | 513,166 | 614,359 | ||||||
Total current liabilities | 1,452,361 | 1,375,857 | ||||||
Long-term financing lease liability | 1,479 | 10,105 | ||||||
Long-term operating lease liability | 273,027 | 274,161 | ||||||
Warrant liability | 184 | 381 | ||||||
Total liabilities | 1,727,051 | 1,660,504 | ||||||
Stockholders' equity | ||||||||
Common stock | 1,798 | 763 | ||||||
Additional paid-in capital | 65,750,337 | 63,263,360 | ||||||
Accumulated deficit | (63,523,164) | (57,565,825) | ||||||
Total stockholders' equity | 2,228,971 | 5,698,298 | ||||||
Total liabilities and stockholders' equity | $ | 3,956,022 | $ | 7,358,802 | ||||
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SOURCE Azitra, Inc.
FAQ
What were Azitra's (AZTR) key financial results for Q2 2025?
What is the status of Azitra's ATR-12 clinical trial for Netherton syndrome?
How much funding did Azitra (AZTR) secure in Q2 2025?
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What are Azitra's (AZTR) upcoming milestones for 2025-2026?
