Acurx Pharmaceuticals, Inc. Reports First Quarter Results and Provides Business Update
Acurx Pharmaceuticals (NASDAQ: ACXP) reported its Q1 2025 financial results and business updates. The company raised $3.6 million through two registered direct offerings and secured a $12 million equity line of credit. Q1 financial highlights include a net loss of $2.1 million ($0.11 per share), improved from a $4.4 million loss year-over-year, with reduced R&D expenses of $0.6 million and G&A expenses of $1.6 million.
Key developments include positive EMA guidance for ibezapolstat's Phase 3 clinical trial program, aligned with FDA requirements. Two significant studies funded by NIAID demonstrated ibezapolstat's microbiome-restorative potential and favorable gut microbiome impact compared to other antibiotics. The company also secured new patents in Japan and India for DNA polymerase IIIC inhibitors, extending protection until December 2039.
Acurx Pharmaceuticals (NASDAQ: ACXP) ha comunicato i risultati finanziari e gli aggiornamenti aziendali del primo trimestre 2025. L'azienda ha raccolto 3,6 milioni di dollari tramite due offerte dirette registrate e ha ottenuto una linea di credito azionaria da 12 milioni di dollari. I dati finanziari del primo trimestre evidenziano una perdita netta di 2,1 milioni di dollari (0,11 dollari per azione), migliorata rispetto alla perdita di 4,4 milioni di dollari dello stesso periodo dell'anno precedente, con una riduzione delle spese di R&S a 0,6 milioni e delle spese generali e amministrative a 1,6 milioni.
Tra i principali sviluppi, si segnala un parere positivo dell'EMA sul programma di studi clinici di fase 3 di ibezapolstat, in linea con i requisiti FDA. Due studi importanti finanziati dal NIAID hanno dimostrato il potenziale di ibezapolstat nel ripristino del microbioma e un impatto favorevole sul microbioma intestinale rispetto ad altri antibiotici. L'azienda ha inoltre ottenuto nuovi brevetti in Giappone e India per gli inibitori della DNA polimerasi IIIC, estendendo la protezione fino a dicembre 2039.
Acurx Pharmaceuticals (NASDAQ: ACXP) reportó sus resultados financieros y actualizaciones comerciales del primer trimestre de 2025. La compañía recaudó 3,6 millones de dólares mediante dos ofertas directas registradas y aseguró una línea de crédito de capital por 12 millones de dólares. Los aspectos financieros del primer trimestre incluyen una pérdida neta de 2,1 millones de dólares (0,11 dólares por acción), mejorando desde una pérdida de 4,4 millones año con año, con gastos reducidos en I+D de 0,6 millones y gastos generales y administrativos de 1,6 millones.
Entre los desarrollos clave, destaca una guía positiva de la EMA para el programa de ensayos clínicos de fase 3 de ibezapolstat, alineada con los requisitos de la FDA. Dos estudios importantes financiados por NIAID demostraron el potencial restaurador del microbioma de ibezapolstat y un impacto favorable en el microbioma intestinal en comparación con otros antibióticos. La compañía también aseguró nuevas patentes en Japón e India para inhibidores de la ADN polimerasa IIIC, extendiendo la protección hasta diciembre de 2039.
Acurx Pharmaceuticals (NASDAQ: ACXP)는 2025년 1분기 재무 결과 및 사업 업데이트를 발표했습니다. 회사는 두 건의 등록 직접 공모를 통해 360만 달러를 조달하고 1,200만 달러의 주식 신용 한도를 확보했습니다. 1분기 재무 하이라이트는 210만 달러(주당 0.11달러)의 순손실로, 전년 동기 440만 달러 손실에서 개선되었으며, 연구개발 비용은 60만 달러, 일반관리비는 160만 달러로 감소했습니다.
주요 발전 사항으로는 FDA 요구사항과 일치하는 ibezapolstat 3상 임상시험 프로그램에 대한 EMA의 긍정적 가이드가 포함됩니다. NIAID가 자금을 지원한 두 건의 주요 연구는 ibezapolstat가 미생물군 복원에 탁월한 잠재력을 보이며 다른 항생제에 비해 장내 미생물군에 긍정적인 영향을 미친다는 점을 입증했습니다. 또한 회사는 일본과 인도에서 DNA 중합효소 IIIC 억제제에 대한 새로운 특허를 확보하여 2039년 12월까지 보호 기간을 연장했습니다.
Acurx Pharmaceuticals (NASDAQ: ACXP) a publié ses résultats financiers et mises à jour commerciales du premier trimestre 2025. La société a levé 3,6 millions de dollars via deux offres directes enregistrées et a obtenu une ligne de crédit en actions de 12 millions de dollars. Les points financiers clés du T1 incluent une perte nette de 2,1 millions de dollars (0,11 dollar par action), améliorée par rapport à une perte de 4,4 millions d'euros sur un an, avec des dépenses de R&D réduites à 0,6 million et des frais G&A à 1,6 million.
Parmi les développements majeurs, on note une orientation positive de l'EMA pour le programme d'essais cliniques de phase 3 d’ibezapolstat, conforme aux exigences de la FDA. Deux études importantes financées par le NIAID ont démontré le potentiel restaurateur du microbiome d’ibezapolstat et un impact favorable sur le microbiome intestinal comparé à d'autres antibiotiques. La société a également obtenu de nouveaux brevets au Japon et en Inde pour les inhibiteurs de l’ADN polymérase IIIC, prolongeant la protection jusqu’en décembre 2039.
Acurx Pharmaceuticals (NASDAQ: ACXP) veröffentlichte seine Finanzergebnisse und Geschäftsupdates für das erste Quartal 2025. Das Unternehmen erzielte 3,6 Millionen US-Dollar durch zwei registrierte Direktplatzierungen und sicherte sich eine Eigenkapitallinie von 12 Millionen US-Dollar. Die Finanzergebnisse des ersten Quartals zeigen einen Nettoverlust von 2,1 Millionen US-Dollar (0,11 US-Dollar je Aktie), verbessert gegenüber einem Verlust von 4,4 Millionen US-Dollar im Vorjahreszeitraum, mit reduzierten F&E-Ausgaben von 0,6 Millionen und Verwaltungsaufwendungen von 1,6 Millionen.
Wesentliche Entwicklungen umfassen eine positive EMA-Richtlinie für das Phase-3-Studienprogramm von Ibezapolstat, das mit den FDA-Anforderungen übereinstimmt. Zwei bedeutende vom NIAID finanzierte Studien zeigten das mikrobiom-wiederherstellende Potenzial von Ibezapolstat und eine günstige Wirkung auf das Darmmikrobiom im Vergleich zu anderen Antibiotika. Das Unternehmen sicherte sich zudem neue Patente in Japan und Indien für DNA-Polymerase IIIC-Inhibitoren, die den Schutz bis Dezember 2039 verlängern.
- None.
- Continued net losses of $2.1M in Q1 2025
- Multiple equity raises may lead to dilution for existing shareholders
Insights
Acurx's Q1 shows narrowing losses and promising ibezapolstat data, though cash concerns persist despite recent funding.
Acurx Pharmaceuticals' Q1 2025 results reveal significant financial and operational developments for this late-stage biopharma company. The company successfully raised
The company has made substantial progress with their lead candidate ibezapolstat (IBZ), a novel antibiotic for C. difficile infection (CDI). Notably, Acurx received positive regulatory guidance from the European Medicines Agency, aligning with previous FDA feedback regarding manufacturing, non-clinical, and clinical aspects of their Phase 3 program. This dual regulatory alignment establishes a clear pathway to market in both major regions.
Two significant scientific publications emerged this quarter, both highlighting IBZ's competitive advantages. The first study, an in-silico analysis funded by NIAID, predicted IBZ's microbiome-restorative potential - providing mechanistic explanation for the drug's selectivity. The second study compared IBZ's impact on gut microbiome against other CDI antibiotics, showing less pronounced microbiome disruption compared to vancomycin and metronidazole, with notable differences from fidaxomicin. These findings suggest IBZ could potentially reduce CDI recurrence rates without requiring expensive microbiome therapeutic agents.
Financially, Acurx demonstrated improved operational efficiency with R&D expenses decreasing to
The company also strengthened its intellectual property portfolio with new patents in Japan and India for their DNA polymerase IIIC inhibitors, extending protection until 2039. These patents support the development of ACX-375C, their preclinical candidate targeting MRSA, VRE, and anthrax infections.
Despite these positive developments, the company's quarterly cash burn of approximately
Highlights of the first quarter ended March 31, 2025, or in some cases shortly thereafter, include:
- In January 2025, the Company announced it had closed a
$2.5 million - Also in January 2025, we announced that we received positive regulatory guidance from the European Medicines Agency (EMA) for the ibezapolstat (IBZ) Phase 3 clinical trial program, which is aligned with FDA on matters of manufacturing, non-clinical and clinical aspects of the Phase 3 program. The EMA guidance also confirmed ibezapolstat's regulatory pathway for a Marketing Authorization Application to be filed by the Company after successful completion of the Phase 3 clinical trials. With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration program.
- In February 2025 and in March 2025, we announced new publications in the Journal of Antimicrobial Agents and Chemotherapeutics of two very important non-clinical studies which we believe we can leverage to show further positive differentiation for competitive advantage of IBZ vs all other antibiotics used for the first line therapy of C. difficile infection. And, given our clinical results to date, we're hopeful that this anti-recurrence effect of IBZ could mitigate the need for expensive microbiome therapeutic agents to prevent recurrent CDI.
- In February 2025, we announced positive results from this first study, conducted by Dr. Justin McPherson from the University of
Houston and funded by the National Institute of Allergy and Infectious Diseases (or NIAID). It was an in-silico study that predicted the microbiome-restorative potential of IBZ for treating CDI. Our scientific advisors consider this to be a major finding which provides a mechanistic explanation for IBZ's selectivity in that the predicted bactericidal interaction between IBZ and its target, the DNA pol IIIC enzyme, allows regrowth of gut microbes known to confer health benefits. - In March 2025, we announced the second study, conducted by Dr. Trenton Wolfe, from the University of
Montana , which was funded by the National Institute of Allergy and Infectious Diseases (NIAID), the National Cancer Institute (NCI), National Center for Advancing Translational Sciences (NCATS), and the Company. This study is the first ever head-to-head comparison of gut microbiome changes associated with IBZ when compared to other anti-CDI antibiotics in a germ-free mouse model. The data showed that changes in alpha and beta microbiome diversities following IBZ treatment were less pronounced compared to those observed in vancomycin (VAN)-or metronidazole (MET)-treated groups, complementing prior Phase 2 clinical findings showing IBZ's more selective antibacterial activity. Further, and very importantly, notable differences were observed between the microbiome of IBZ- and the fidaxomicin (FDX)-treated groups, which may allow for differentiation of these two anti-CDI antibiotics in future studies.These results establish IBZ's differentiating effects on the gut microbiome, indicating a more selective spectrum of microbiome alteration compared to broader-spectrum antibiotics like VAN and MET and a narrower spectrum of microbiome alteration compared to FDX. - Also in February 2025, the Japanese Patent Office granted a new patent for our DNA polymerase IIIC inhibitors which expires in December 2039, subject to extension. This constitutes a significant building block for our ongoing development of ACX-375C, our pre-clinical antibiotic candidate targeting the treatment of MRSA, VRE and Anthrax infections.
- In March 2025, we announced the closing of a registered direct offering and concurrent private placement, raising gross proceeds of
$1.1 million - In April 2025, the Indian Patent Office granted a new patent for our DNA polymerase IIIC inhibitors which expires in December 2039, subject to extension. This constitutes another significant building block for our ongoing development of ACX-375.
- In May 2025, we closed an equity line of credit with Lincoln Park Capital for up to
$12 million
First Quarter 2025 Financial Results
Cash Position:
The Company ended the quarter with cash totaling
R&D Expenses:
Research and development expenses for the three months ended March 31, 2025 were
G&A Expenses:
General and administrative expenses for the three months ended March 31, 2025 were
Net Income/Loss:
The Company reported a net loss of
The Company had 22,397,511 shares outstanding as of March 31, 2025.
Conference Call
As previously announced, David P. Luci, President and Chief Executive Officer, and Robert G. Shawah, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows:
Date: | Tuesday, May 13, 2025 |
Time: | 8:00 a.m. ET |
Toll free ( | 1-877-790-1503; Conference ID: 13753625 |
International: | Click here for participant international Toll-Free access numbers |
About Ibezapolstat
Ibezapolstat is the Company's lead antibiotic candidate advancing to international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). Ibezapolstat is a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome. In June 2018, ibezapolstat was designated by the
About Acurx Pharmaceuticals, Inc.
Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillinresistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP).
To learn more about Acurx Pharmaceuticals and its product pipeline, please visit www.acurxpharma.com.
Forward-Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the FDA or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the year ended December 31, 2024, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward- looking statements speak only as of the date of this press release, and Acurx disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.
Investor Contact:
Acurx Pharmaceuticals, Inc.
David P. Luci, President & Chief Executive Officer
Tel: 917-533-1469
Email: davidluci@acurxpharma.com
ACURX PHARMACEUTICALS, INC. CONDENSED INTERIM BALANCE SHEETS | ||||||
March 31, | December 31, | |||||
2025 | 2024 | |||||
ASSETS | ||||||
CURRENT ASSETS | ||||||
Cash | $ | 4,643,887 | $ | 3,706,713 | ||
Other Receivable | — | 51,127 | ||||
Prepaid Expenses | 161,574 | 100,123 | ||||
TOTAL ASSETS | $ | 4,805,461 | $ | 3,857,963 | ||
LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||
CURRENT LIABILITIES | ||||||
Accounts Payable and Accrued Expenses | $ | 2,494,062 | $ | 3,242,842 | ||
TOTAL CURRENT LIABILITIES | 2,494,062 | 3,242,842 | ||||
TOTAL LIABILITIES | 2,494,062 | 3,242,842 | ||||
COMMITMENTS AND CONTINGENCIES | ||||||
SHAREHOLDERS' EQUITY | ||||||
Common Stock; 22,397,511 and 17,030,686 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively | 22,398 | 17,031 | ||||
Additional Paid-In Capital | 71,760,150 | 67,920,046 | ||||
Accumulated Deficit | (69,471,149) | (67,321,956) | ||||
TOTAL SHAREHOLDERS' EQUITY | 2,311,399 | 615,121 | ||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 4,805,461 | $ | 3,857,963 | ||
ACURX PHARMACEUTICALS, INC. CONDENSED INTERIM STATEMENTS OF OPERATIONS | ||||||
Three Months Ended | ||||||
March 31, | ||||||
2025 | 2024 | |||||
(unaudited) | (unaudited) | |||||
OPERATING EXPENSES | ||||||
Research and Development | $ | 598,798 | $ | 1,555,011 | ||
General and Administrative | 1,550,395 | 2,822,878 | ||||
TOTAL OPERATING EXPENSES | 2,149,193 | 4,377,889 | ||||
NET LOSS | $ | (2,149,193) | $ | (4,377,889) | ||
LOSS PER SHARE | ||||||
Basic and diluted net loss per common share | $ | (0.11) | $ | (0.28) | ||
Weighted average common shares outstanding, basic and diluted | 20,038,648 | 15,472,507 | ||||
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SOURCE Acurx Pharmaceuticals, Inc.
FAQ
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