Azitra, Inc. Announces Full Year 2024 Financial Results and Provides Business Updates
Azitra (NYSE: AZTR) reported its full year 2024 financial results and business updates. The company initiated a Phase 1b trial for ATR-12 in Netherton syndrome patients, with initial safety data expected in H1 2025 and topline data by year-end 2025. The FDA cleared a Phase 1/2 study of ATR-04 for EGFRi-associated dermal toxicity and granted it Fast Track designation.
Financial highlights include: service revenue of $0.8K (down from $0.7M in 2023), R&D expenses of $4.7M (up from $3.6M), G&A expenses of $6.3M (up from $4.5M), and a net loss of $9.0M (improved from $11.3M in 2023). Cash position stood at $4.6M as of December 31, 2024, with additional $2.2M raised in early 2025.
The company completed public offerings totaling $15M and strengthened its IP portfolio. ATR-04 targets a market opportunity exceeding $1B, affecting approximately 150,000 US patients annually.
Azitra (NYSE: AZTR) ha riportato i risultati finanziari e gli aggiornamenti aziendali per l'intero anno 2024. L'azienda ha avviato uno studio di Fase 1b per ATR-12 in pazienti con sindrome di Netherton, con i dati iniziali di sicurezza attesi nel primo semestre del 2025 e i dati principali entro la fine del 2025. La FDA ha approvato uno studio di Fase 1/2 per ATR-04 per la tossicità dermica associata agli EGFRi e gli ha conferito la designazione Fast Track.
I punti salienti finanziari includono: entrate da servizi di $0.8K (in calo rispetto a $0.7M nel 2023), spese per R&S di $4.7M (in aumento rispetto a $3.6M), spese generali e amministrative di $6.3M (in aumento rispetto a $4.5M), e una perdita netta di $9.0M (migliorata rispetto a $11.3M nel 2023). La posizione di cassa si attestava a $4.6M al 31 dicembre 2024, con ulteriori $2.2M raccolti all'inizio del 2025.
L'azienda ha completato offerte pubbliche per un totale di $15M e ha rafforzato il proprio portafoglio di proprietà intellettuale. ATR-04 mira a un'opportunità di mercato che supera $1B, interessando circa 150.000 pazienti negli Stati Uniti ogni anno.
Azitra (NYSE: AZTR) informó sus resultados financieros y actualizaciones comerciales para el año completo 2024. La compañía inició un ensayo de Fase 1b para ATR-12 en pacientes con síndrome de Netherton, con los primeros datos de seguridad esperados para el primer semestre de 2025 y los datos principales para finales de 2025. La FDA aprobó un estudio de Fase 1/2 para ATR-04 por toxicidad dérmica asociada a EGFRi y le otorgó la designación de Fast Track.
Los aspectos financieros destacados incluyen: ingresos por servicios de $0.8K (bajando de $0.7M en 2023), gastos en I+D de $4.7M (aumentando desde $3.6M), gastos generales y administrativos de $6.3M (aumentando desde $4.5M), y una pérdida neta de $9.0M (mejorada desde $11.3M en 2023). La posición de efectivo se situó en $4.6M al 31 de diciembre de 2024, con $2.2M adicionales recaudados a principios de 2025.
La compañía completó ofertas públicas por un total de $15M y fortaleció su cartera de propiedad intelectual. ATR-04 apunta a una oportunidad de mercado que supera los $1B, afectando a aproximadamente 150,000 pacientes en EE. UU. anualmente.
Azitra (NYSE: AZTR)는 2024년 전체 재무 결과 및 비즈니스 업데이트를 보고했습니다. 이 회사는 Netherton 증후군 환자를 대상으로 ATR-12에 대한 1b상 시험을 시작했으며, 초기 안전성 데이터는 2025년 상반기에 예상되며, 주요 데이터는 2025년 연말까지 제공될 예정입니다. FDA는 EGFRi와 관련된 피부 독성에 대한 ATR-04의 1/2상 연구를 승인하고 신속 심사(Fast Track) 지정을 부여했습니다.
재무 하이라이트는 다음과 같습니다: 서비스 수익 $0.8K (2023년 $0.7M에서 감소), R&D 비용 $4.7M (2023년 $3.6M에서 증가), G&A 비용 $6.3M (2023년 $4.5M에서 증가), 그리고 순손실 $9.0M (2023년 $11.3M에서 개선). 2024년 12월 31일 기준 현금 잔고는 $4.6M이며, 2025년 초에 추가로 $2.2M이 모금되었습니다.
회사는 총 $15M의 공모를 완료하고 지적 재산 포트폴리오를 강화했습니다. ATR-04는 연간 약 150,000명의 미국 환자에게 영향을 미치는 10억 달러 이상의 시장 기회를 목표로 하고 있습니다.
Azitra (NYSE: AZTR) a publié ses résultats financiers et ses mises à jour commerciales pour l'année complète 2024. La société a lancé un essai de Phase 1b pour l'ATR-12 chez des patients atteints du syndrome de Netherton, avec des données de sécurité initiales attendues au premier semestre 2025 et des données principales d'ici la fin 2025. La FDA a approuvé une étude de Phase 1/2 pour l'ATR-04 concernant la toxicité cutanée associée aux EGFRi et lui a accordé la désignation Fast Track.
Les points forts financiers incluent : revenus de services de $0.8K (en baisse par rapport à $0.7M en 2023), dépenses de R&D de $4.7M (en hausse par rapport à $3.6M), dépenses générales et administratives de $6.3M (en hausse par rapport à $4.5M), et une perte nette de $9.0M (améliorée par rapport à $11.3M en 2023). La position de liquidité s'élevait à $4.6M au 31 décembre 2024, avec $2.2M supplémentaires levés au début de 2025.
La société a complété des offres publiques totalisant $15M et a renforcé son portefeuille de propriété intellectuelle. L'ATR-04 vise une opportunité de marché dépassant $1B, touchant environ 150 000 patients américains chaque année.
Azitra (NYSE: AZTR) hat seine finanziellen Ergebnisse und Geschäftsupdates für das gesamte Jahr 2024 veröffentlicht. Das Unternehmen hat eine Phase-1b-Studie für ATR-12 bei Patienten mit Netherton-Syndrom initiiert, wobei die ersten Sicherheitsdaten im ersten Halbjahr 2025 und die Hauptdaten bis Ende 2025 erwartet werden. Die FDA hat eine Phase-1/2-Studie zu ATR-04 bei EGFRi-assoziierter Hauttoxizität genehmigt und ihm die Fast-Track-Bezeichnung erteilt.
Zu den finanziellen Höhepunkten gehören: Serviceumsätze von $0.8K (rückläufig von $0.7M im Jahr 2023), F&E-Ausgaben von $4.7M (steigend von $3.6M), Verwaltungskosten von $6.3M (steigend von $4.5M) und ein Nettoverlust von $9.0M (verbessert von $11.3M im Jahr 2023). Die Liquiditätsposition betrug zum 31. Dezember 2024 $4.6M, mit zusätzlichen $2.2M, die Anfang 2025 gesammelt wurden.
Das Unternehmen hat öffentliche Angebote in Höhe von insgesamt $15M abgeschlossen und sein IP-Portfolio gestärkt. ATR-04 zielt auf eine Marktchance von über $1B ab, die jährlich etwa 150.000 US-Patienten betrifft.
- FDA Fast Track designation received for ATR-04
- Net loss improved to $9.0M from $11.3M in 2023
- Successfully raised $15M through public offerings
- ATR-04 addresses $1B+ market opportunity
- Service revenue declined significantly to $0.8K from $0.7M in 2023
- R&D expenses increased 30.6% to $4.7M
- G&A expenses increased 40% to $6.3M
- Low cash position of $4.6M relative to operating expenses
Insights
The financial picture reveals both opportunities and challenges for Azitra. The company's net loss improvement to
The current cash position of
The pipeline developments present significant value-creation opportunities. The Fast Track designation for ATR-04 is particularly strategic, potentially accelerating the path to market and reducing development costs. The
The company's focus on engineered S. epidermidis strains for protein delivery through the skin barrier represents a novel approach in dermatology. The upcoming clinical milestones in 2025, particularly the ATR-12 Phase 1b data readouts, will be important inflection points that could validate the platform technology and potentially attract strategic partnerships or additional investment.
FY 2024 and Recent Business Highlights
- Initiated a Phase 1b clinical trial investigating ATR-12 in adult Netherton syndrome patients; Initial safety data from first set of Netherton syndrome patients expected in the first half of 2025 with topline data from the Phase 1b trial by year-end 2025
- Received clearance from the
U.S. Food and Drug Administration (FDA) for a first-in-human Phase 1/2 clinical study of ATR-04 for adults with moderate to severe EGFRi-associated dermal toxicity - FDA granted Fast Track designation to ATR-04, demonstrating that the FDA recognizes the unmet need for treatment of EGFRi-associated skin rash
- Announced closing of
$10.0 million $5.0 million - Strengthened intellectual property (IP) portfolio with newly granted and allowed patents
"This is a very exciting time in the growth and evolution of Azitra as we seek to drive shareholder value through development of first-in-class drugs to treat dermatological diseases," said Francisco Salva, CEO of Azitra. "Azitra is currently advancing a therapeutic pipeline with multiple programs developed from our proprietary platform of engineered proteins delivered using topical live biotherapeutic products. Our initial focus is the development of genetically engineered strains of Staphylococcus epidermidis (S. epidermidis) to enable the delivery of critical missing natural proteins and disease-modifying proteins through the stratum corneum of the skin. This advantage could allow Azitra to address several dermatological conditions that are significantly underserved by current standards of care."
Salva continued, "Our lead product, ATR-12, is an engineered strain of S. epidermidis designed to treat Netherton syndrome, a rare, chronic skin disease with no approved treatment options. In August 2024, we initiated a Phase 1b clinical trial investigating ATR-12 in adult Netherton syndrome patients to assess multiple safety, tolerability, and efficacy endpoints. Initial safety data from this trial is expected in the first half of 2025 with topline results by year-end 2025."
Salva continued, "In addition to ATR-12, Azitra has made significant progress with our next most advanced product, ATR-04. ATR-04 is a live biotherapeutic product candidate containing an isolated, naturally derived S. epidermidis strain being developed for the treatment of EGFR inhibitor ("EGFRi") associated rash, which impacts approximately 150,000 patients in
Salva concluded, "We look forward to capitalizing on multiple value-building milestones during 2025, including clinical data from our ATR-12 program. These events are expected to provide key inflection points for the company and investors throughout the year as we continue to position Azitra as a leading and innovative company developing transformative drugs for underserved patients with life-altering dermatological diseases."
Pipeline and Upcoming Milestones
ATR-12 - Advancing Phase 1b Clinical Trial in Netherton Syndrome with Multiple Milestones Expected
- In August 2024, initiated a Phase 1b clinical trial investigating ATR-12 in adult Netherton syndrome patients. Trial is designed to assess multiple safety, tolerability, and efficacy endpoints, providing a springboard for several potential value creating events during the year
- Initial safety data from first set of Netherton syndrome patients in the first half of 2025
- Topline data from the Phase 1b trial by year-end 2025
Azitra presented compelling preclinical data for ATR-12 in Netherton syndrome at the American Society of Gene and Cell Therapy (ASGCT) 2024 Annual Meeting. Among the findings presented at the conference, ATR-12 significantly reduced protease activity in skin samples compared to a Netherton syndrome model skin (p<0.01). Additionally, ATR-12 produced higher amounts of LEKTI subunit compared to topical application of LEKTI protein alone after 24 hours and resulted in deeper skin penetration of LEKTI.
ATR-04 – Addressing an Unmet Need in a Multi-billion Dollar Market Opportunity
- In August, Azitra received clearance from the
U.S. Food and Drug Administration (FDA) for a first-in-human Phase 1/2 clinical study of ATR-04 for moderate to severe EGFRi-associated dermal toxicity - In September, the FDA granted Fast Track designation to ATR-04, demonstrating that the FDA recognizes the unmet need for treatment of EGFRi-associated skin rash
- Also in 2024, Azitra presented preclinical data at the Society of Investigative Dermatology (SID) and the European Academy of Dermatology and Venereology (EADV) annual meetings showing ATR-04 inhibits IL-36g and S. aureus, both of which are key drivers of the disease
- Plan to initiate a multicenter, randomized, controlled Phase 1/2 clinical trial in patients undergoing EGFR inhibitors with dermal toxicity in first half of 2025
Financial Results for the Year Ended December 31, 2024
Service Revenue – Related Party: The Company generated
Research and Development (R&D) expenses: R&D expenses for the year ended December 31, 2024, were
General and Administrative (G&A) expenses: G&A expenses for the year ended December 31, 2024, were
Net Loss was
Cash and cash equivalents: As of December 31, 2024, the Company had cash and cash equivalents of
About Azitra, Inc.
Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology. The Company's lead product, ATR-12, is an engineered strain of S. epidermidis designed to treat Netherton syndrome, a rare, chronic skin disease with no approved treatment options. Netherton syndrome is often fatal in infancy with those living beyond a year having profound lifelong challenges. ATR-12 is being evaluated in a Phase 1b clinical trial in adult Netherton syndrome patients. ATR-04, Azitra's next most advanced product, is being developed 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
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 initiation of the Phase 1/2 clinical trial 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 we may experience delays in reporting initial safety and topline data for our Phase 1b trial for ATR-12; we may experience delays in the initiation of our Phase 1/2 trial for 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 our Annual Report on Form 10-K filed with the SEC on February 20, 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 | ||||||||
Audited | ||||||||
December 31, | ||||||||
2024 | 2023 | |||||||
Service revenue – related party | $ | 7,500 | $ | 686,000 | ||||
Total revenue | 7,500 | 686,000 | ||||||
Operating expenses: | ||||||||
General and administrative | 6,269,262 | 4,493,332 | ||||||
Research and development | 4,723,378 | 3,643,214 | ||||||
Total operating expenses | 10,992,640 | 8,136,546 | ||||||
Loss from operations | (10,985,140) | (7,450,546) | ||||||
Other income (expense): | ||||||||
Interest income | 122,553 | 1,577 | ||||||
Interest expense | (12,160) | (167,726) | ||||||
Change in fair value of convertible note | - | (3,630,100) | ||||||
Change in fair value of warrants | 4,034,072 | 34,930 | ||||||
Loss on issuance of common stock | (2,132,800) | - | ||||||
Other income (expense) | 15,014 | (54,608) | ||||||
Total other income (expense) | 2,026,679 | (3,815,927) | ||||||
Net loss before income taxes | (8,958,461) | (11,266,473) | ||||||
Income tax expense | (9,031) | (17,308) | ||||||
Net loss | $ | (8,967,492) | (11,283,781) | |||||
Dividends on preferred stock | - | (1,355,347) | ||||||
Net loss attributable to common shareholders | $ | (8,967,492) | (12,639,128) | |||||
Net loss per Share, basic and diluted | $ | (2.37) | $ | (54.98) | ||||
Weighted average common stock outstanding, basic and diluted | 3,784,482 | 229,866 | ||||||
Condensed Balance Sheets | ||||||||
Audited | ||||||||
December 31, | December 31, | |||||||
2024 | 2023 | |||||||
Assets | ||||||||
Current Assets: | ||||||||
Cash and cash equivalents | $ | 4,554,719 | $ | 1,795,989 | ||||
Other receivables | 101,896 | 223,474 | ||||||
Prepaid expenses and other current assets | 571,675 | 516,116 | ||||||
Total current assets | $ | 5,228,290 | $ | 2,535,579 | ||||
Property and equipment, net | 653,957 | 710,075 | ||||||
Other assets | 1,476,555 | 1,869,832 | ||||||
Total assets | $ | 7,358,802 | $ | 5,115,486 | ||||
Liabilities, and stockholders' equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 490,255 | $ | 897,272 | ||||
11,572 | - | |||||||
Current financing lease liability | 16,066 | 14,600 | ||||||
Current operating lease liability | 255,177 | 307,655 | ||||||
Accrued expenses | 602,787 | 383,668 | ||||||
Total current liabilities | 1,375,857 | 1,603,195 | ||||||
Long-term financing lease liability | 10,105 | 26,169 | ||||||
Long-term operating lease liability | 274,161 | 537,523 | ||||||
Warrant liability | 381 | 35,453 | ||||||
Total liabilities | 1,660,504 | 2,202,340 | ||||||
Stockholders' equity | ||||||||
Common stock | 763 | 40 | ||||||
Additional paid-in capital | 63,263,360 | 51,510,269 | ||||||
Accumulated deficit | (57,565,825) | (48,597,163) | ||||||
Total stockholders' equity | 5,698,298 | 2,913,146 | ||||||
Total liabilities and stockholders' equity | $ | 7,358,802 | $ | 5,115,486 | ||||
View original content to download multimedia:https://www.prnewswire.com/news-releases/azitra-inc-announces-full-year-2024-financial-results-and-provides-business-updates-302382885.html
SOURCE Azitra, Inc.
FAQ
What were Azitra's (AZTR) key financial results for FY 2024?
When will Azitra (AZTR) release ATR-12 clinical trial data in 2025?
What is the market opportunity for Azitra's (AZTR) ATR-04 treatment?
How much capital did Azitra (AZTR) raise in 2024?
