Azitra, Inc. Announces Q3 2024 Financial Results and Provides Business Updates
Azitra (AZTR) reported Q3 2024 financial results and business updates. Key highlights include completing a $10 million follow-on offering, dosing the first Netherton syndrome patient with ATR-12, and receiving FDA Fast Track designation for ATR-04. Financial results show zero service revenue compared to $310,700 in Q3 2023, R&D expenses of $1.0 million (up from $0.5 million), and G&A expenses of $1.9 million. The company reported a net loss of $1.0 million and held cash and equivalents of $7.3 million as of September 30, 2024. Upcoming milestones include initial safety data and first patient dosing for key trials in Q1 2025.
Azitra (AZTR) ha riportato i risultati finanziari del terzo trimestre 2024 e aggiornamenti aziendali. I punti salienti includono il completamento di un offerta supplementare da 10 milioni di dollari, la somministrazione del primo paziente con sindrome di Netherton di ATR-12 e il ricevimento della designazione Fast Track dalla FDA per ATR-04. I risultati finanziari mostrano zero ricavi da servizi rispetto ai 310.700 dollari del terzo trimestre 2023, spese per R&S di 1,0 milioni di dollari (in aumento rispetto ai 0,5 milioni), e spese generali e amministrative di 1,9 milioni di dollari. L'azienda ha riportato una perdita netta di 1,0 milioni di dollari e deteneva liquidità e equivalenti per 7,3 milioni di dollari al 30 settembre 2024. I prossimi traguardi includono i dati iniziali sulla sicurezza e la somministrazione del primo paziente per prove chiave nel primo trimestre del 2025.
Azitra (AZTR) anunció los resultados financieros del tercer trimestre de 2024 y actualizaciones comerciales. Los aspectos más destacados incluyen la finalización de una oferta de seguimiento de 10 millones de dólares, la dosificación del primer paciente con síndrome de Netherton con ATR-12 y la obtención de la designación de Fast Track por parte de la FDA para ATR-04. Los resultados financieros muestran cero ingresos por servicios en comparación con 310,700 dólares en el tercer trimestre de 2023, gastos de I+D de 1.0 millón de dólares (un aumento desde 0.5 millones) y gastos generales y administrativos de 1.9 millones de dólares. La compañía reportó una pérdida neta de 1.0 millón de dólares y tenía en caja y equivalentes 7.3 millones de dólares hasta el 30 de septiembre de 2024. Los próximos hitos incluyen los datos iniciales de seguridad y la dosificación del primer paciente para ensayos clave en el primer trimestre de 2025.
Azitra (AZTR)는 2024년 3분기 재무 결과와 사업 업데이트를 발표했습니다. 주요 내용으로는 1천만 달러 후속 공모 완료, ATR-12로 넷허튼 증후군 환자 첫 투여, ATR-04에 대한 FDA 신속 심사 지정 획득이 포함됩니다. 재무 결과는 서비스 수익이 제로이고, 2023년 3분기의 310,700달러에 비해 연구 개발 비용이 100만 달러(500,000달러에서 증가)이며, 관리비용은 190만 달러로 나타났습니다. 회사는 100만 달러의 순손실을 보고했고, 2024년 9월 30일 기준으로 현금 및 현금 등가물이 730만 달러를 보유하고 있습니다. 향후 이정표로는 2025년 1분기에 주요 시험의 초기 안전 데이터와 첫 환자 투여가 포함됩니다.
Azitra (AZTR) a annoncé les résultats financiers du troisième trimestre 2024 et des mises à jour commerciales. Les points saillants incluent l'achèvement d'une offre de suivi de 10 millions de dollars, l'administration du premier patient atteint du syndrome de Netherton avec ATR-12 et l'obtention de la désignation Fast Track de la FDA pour ATR-04. Les résultats financiers montrent zero revenu de services par rapport à 310 700 dollars au troisième trimestre 2023, des dépenses de R&D de 1,0 million de dollars (en hausse par rapport à 0,5 million) et des dépenses générales et administratives de 1,9 million de dollars. La société a signalé une perte nette de 1 million de dollars et détenait des liquidités et équivalents de 7,3 millions de dollars au 30 septembre 2024. Les prochaines étapes comprennent les premières données de sécurité et l'administration du premier patient pour des essais clés au premier trimestre 2025.
Azitra (AZTR) hat die finanziellen Ergebnisse für das dritte Quartal 2024 und Unternehmensaktualisierungen bekannt gegeben. Zu den wichtigsten Punkten gehören der Abschluss einer 10 Millionen Dollar follow-on Angebots, die Dosierung des ersten Patienten mit Netherton-Syndrom mit ATR-12 und die Erhalt der Fast-Track-Auszeichnung der FDA für ATR-04. Die finanziellen Ergebnisse zeigen null Dienstleistungsumsatz im Vergleich zu 310.700 Dollar im dritten Quartal 2023, Forschung- und Entwicklungskosten in Höhe von 1 Millionen Dollar (ein Anstieg von 0,5 Millionen) und allgemeine und administrative Kosten von 1,9 Millionen Dollar. Das Unternehmen berichtete von einem netto Verlust von 1 Millionen Dollar und hielt zum 30. September 2024 7,3 Millionen Dollar an Bargeld und Äquivalenten. Zukünftige Meilensteine umfassen die ersten Sicherheitsdaten und die Dosierung des ersten Patienten für wichtige Studien im ersten Quartal 2025.
- Received FDA Fast Track designation for ATR-04
- Completed $10 million follow-on offering
- Net loss decreased from $1.9M to $1.0M year-over-year
- Successfully dosed first patient in Netherton syndrome trial
- Service revenue dropped to $0 from $310,700 year-over-year
- R&D expenses doubled to $1.0M from $0.5M year-over-year
- G&A expenses increased to $1.9M from $1.8M year-over-year
Insights
This quarter shows mixed financial signals. The
The narrowed net loss to
The clinical progress demonstrates strong execution across multiple programs. The Fast Track designation for ATR-04 validates the unmet need in EGFR inhibitor-induced skin rash, a significant market opportunity affecting up to
The upcoming Q1 2025 readouts for both programs represent major catalysts. The strengthened IP portfolio and regulatory achievements (IND clearance, Fast Track) enhance the company's competitive position. The clinical timeline appears well-structured with multiple value-driving events through 2025.
Q3 2024 and Recent Business Highlights:
- Completed a follow-on offering of
$10 million - Dosed first Netherton syndrome patient with ATR-12
- Submitted an IND to the FDA and received IND clearance for ATR-04 to treat skin rash from EGFR inhibitors
- Received Fast Track designation from the FDA for ATR-04
- Presented positive preclinical data and the clinical plan of a Phase 1/2 clinical study of ATR-04 in a late-breaking presentation at the European Academy of Dermatology and Venereology (EADV) Congress
- Strengthened intellectual property (IP) portfolio with newly granted and allowed patents
Francisco Salva, CEO of Azitra commented:
"Azitra achieved a number of significant milestones in the third quarter of 2024 to propel our pipeline forward, highlighted by the dosing of the first patient with ATR-12 in our ongoing Netherton syndrome trial. Additionally during the quarter, we completed a follow-on offering of
"With a clear roadmap, strong execution on two programs, and a dedicated team, Azitra is well-positioned to execute these milestones, deliver transformative therapies to patients in need, and ultimately maximize shareholder value."
Pipeline and Anticipated Milestones
- Q1 2025: Initial safety data from first set of Netherton syndrome patients in the Phase 1b trial
- Q1 2025: First patient dosed with ATR-04 for EGFRi rash in a Phase 1/2 trial
- YE 2025: Topline data of the Phase 1b trial with ATR-12 in Netherton syndrome patients expected
Financial Results for the Three Months Ended September 30, 2024
- Service Revenue – Related Party: The Company generated
$0 $310,700 - Research and Development (R&D) expenses: R&D expenses for the quarter ended September 30, 2024, were
$1.0 million $0.5 million - General and Administrative (G&A) expenses: G&A expenses for the quarter ended September 30, 2024, were
$1.9 million $1.8 million - Net Loss was
$1.0 million $1.9 million - Cash and cash equivalents: As of September 30, 2024, the Company had cash and cash equivalents of
$7.3 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 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
About Azitra, Inc.
Azitra, Inc. is an early-stage clinical biopharmaceutical company focused on developing innovative therapies for precision dermatology using engineered proteins and topical live biotherapeutic products. The Company has built a proprietary platform that includes a microbial library comprised of approximately 1,500 unique bacterial strains that can be screened for unique therapeutic characteristics. The platform is augmented by artificial intelligence and machine learning technology that analyzes, predicts, and helps screen the Company's library of strains for drug like molecules. The Company's initial focus is on the development of genetically engineered strains of Staphylococcus epidermidis, or S. epidermidis, which the Company considers to be an optimal therapeutic candidate species for engineering of dermatologic therapies. 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 the presentation of data from the Phase 1b study of ATR-12, the filing of an IND application, and the presentation of data from our Phase 1b for ATR-04, the IND filing for ATR-01, the timing of having a signed license agreement with Bayer, and statements about our clinical and pre-clinical programs, and corporate and clinical/pre-clinical 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 fail to successfully complete our Phase 1b trial for ATR-12, we may experience delays in the initiation of our Phase 1/2 trial fpr ATR-04, ; 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 prospectus dated July 23, 2024 filed with the SEC on July 25, 2024 in our most recent quarterly report on Form 10-Q filed with the SEC on November 12, 2024. 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
Tiberend Strategic Advisors, Inc.
Jon Nugent
205-566-3026
jnugent@tiberend.com
Condensed Statement of Operations (Unaudited) | ||||||||
Three months Ended September 30, | ||||||||
2024 | 2023 | |||||||
Service revenue – related party | $ | - | $ | 310,700 | ||||
Total revenue | - | 310,700 | ||||||
Operating expenses: | ||||||||
General and administrative | 1,913,400 | 1,755,908 | ||||||
Research and development | 1,015,807 | 548,524 | ||||||
Total operating expenses | 2,929,207 | 2,304,432 | ||||||
Loss from operations | (2,929,207) | (1,993,732) | ||||||
Other income (expense): | ||||||||
Interest income | 47,389 | 634 | ||||||
Interest expense | (3,851) | (710) | ||||||
Change in fair value of warrants | 4,001,469 | 98,061 | ||||||
Loss on issuance of common stock | (2,132,800) | - | ||||||
Other income (expense) | 7,509 | (47,542) | ||||||
Total other income (expense) | 1,919,716 | 50,443 | ||||||
Net loss before income taxes | (1,009,491) | (1,943,289) | ||||||
Income tax expense | - | - | ||||||
Net loss | $ | (1,009,491) | (1,943,289) | |||||
Dividends on preferred stock | - | - | ||||||
Net loss attributable to common shareholders | $ | (1,009,491) | (1,943,289) | |||||
Net loss per Share, basic and diluted | $ | (.17) | $ | (4.82) | ||||
Weighted average common stock outstanding, basic and diluted | 5,814,350 | 403,255 | ||||||
Condensed Balance Sheets (Unaudited) | ||||||||
September 30, | December 31, | |||||||
2024 | 2023 | |||||||
Assets | ||||||||
Current Assets: | ||||||||
Cash and cash equivalents | $ | 7,260,234 | $ | 1,795,989 | ||||
Other receivables | 9,923 | 223,474 | ||||||
Prepaid expenses and other current assets | 364,673 | 516,116 | ||||||
Total current assets | $ | 7,634,830 | $ | 2,535,579 | ||||
Property and equipment, net | 638,107 | 710,075 | ||||||
Other assets | 1,504,562 | 1,869,832 | ||||||
Total assets | $ | 9,777,499 | $ | 5,115,486 | ||||
Liabilities, and stockholders' equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 588,460 | $ | 897,272 | ||||
Current financing lease liability | 15,687 | 14,600 | ||||||
Current operating lease liability | 276,839 | 307,655 | ||||||
Accrued expenses | 486,981 | 383,668 | ||||||
Total current liabilities | 1,367,967 | 1,603,195 | ||||||
Long-term financing lease liability | 14,266 | 26,169 | ||||||
Long-term operating lease liability | 336,556 | 537,523 | ||||||
Warrant liability | 457 | 35,453 | ||||||
Total liabilities | 1,719,246 | 2,202,340 | ||||||
Stockholders' equity | ||||||||
Common stock | 763 | 40 | ||||||
Additional paid-in capital | 63,230,182 | 51,510,269 | ||||||
Accumulated deficit | (55,172,692) | (48,597,163) | ||||||
Total stockholders' equity | 8,058,253 | 2,913,146 | ||||||
Total liabilities and stockholders' equity | $ | 9,777,499 | $ | 5,115,486 | ||||
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SOURCE Azitra, Inc.
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