Acurx Pharmaceuticals, Inc. Reports Fourth Quarter and Full Year 2024 Results and Provides Business Update
Acurx Pharmaceuticals (NASDAQ: ACXP) has reported its Q4 and full-year 2024 results. Key highlights include positive Phase 2b clinical trial results for ibezapolstat, showing a 96% clinical cure rate across combined Phase 2 trials, with 100% sustained cure rate through one month post-treatment, compared to 86% for vancomycin.
The company secured positive regulatory guidance from EMA for ibezapolstat's Phase 3 program, aligning with FDA requirements. Financial results show cash position of $3.7 million as of December 31, 2024, down from $7.5 million year-over-year. The company raised $6.6 million through ATM financing in 2024.
Q4 2024 showed reduced losses with net loss of $2.8 million ($0.16 per share) compared to $5.1 million ($0.37 per share) in Q4 2023. Full-year 2024 net loss was $14.1 million ($0.87 per share) versus $14.6 million ($1.15 per share) in 2023.
Acurx Pharmaceuticals (NASDAQ: ACXP) ha riportato i risultati del quarto trimestre e dell'intero anno 2024. I punti salienti includono risultati positivi della fase 2b della sperimentazione clinica per ibezapolstat, che mostra un tasso di guarigione clinica del 96% nei trial di fase 2 combinati, con un tasso di guarigione sostenuto del 100% fino a un mese dopo il trattamento, rispetto all'86% per la vancomicina.
L'azienda ha ottenuto una guida normativa positiva dall'EMA per il programma di fase 3 di ibezapolstat, in linea con i requisiti della FDA. I risultati finanziari mostrano una posizione di cassa di $3.7 milioni al 31 dicembre 2024, in calo rispetto ai $7.5 milioni dell'anno precedente. L'azienda ha raccolto $6.6 milioni tramite finanziamenti ATM nel 2024.
Il quarto trimestre del 2024 ha mostrato perdite ridotte con una perdita netta di $2.8 milioni ($0.16 per azione) rispetto ai $5.1 milioni ($0.37 per azione) nel quarto trimestre del 2023. La perdita netta dell'intero anno 2024 è stata di $14.1 milioni ($0.87 per azione) rispetto ai $14.6 milioni ($1.15 per azione) nel 2023.
Acurx Pharmaceuticals (NASDAQ: ACXP) ha informado sus resultados del cuarto trimestre y del año completo 2024. Los aspectos más destacados incluyen resultados positivos del ensayo clínico de fase 2b para ibezapolstat, mostrando una tasa de curación clínica del 96% en los ensayos de fase 2 combinados, con una tasa de curación sostenida del 100% hasta un mes después del tratamiento, en comparación con el 86% para la vancomicina.
La compañía obtuvo una guía regulatoria positiva de la EMA para el programa de fase 3 de ibezapolstat, alineándose con los requisitos de la FDA. Los resultados financieros muestran una posición de efectivo de $3.7 millones al 31 de diciembre de 2024, en comparación con $7.5 millones del año anterior. La empresa recaudó $6.6 millones a través de financiamiento ATM en 2024.
El cuarto trimestre de 2024 mostró pérdidas reducidas con una pérdida neta de $2.8 millones ($0.16 por acción) en comparación con $5.1 millones ($0.37 por acción) en el cuarto trimestre de 2023. La pérdida neta del año completo 2024 fue de $14.1 millones ($0.87 por acción) frente a $14.6 millones ($1.15 por acción) en 2023.
Acurx Pharmaceuticals (NASDAQ: ACXP)는 2024년 4분기 및 연간 실적을 발표했습니다. 주요 하이라이트는 ibezapolstat의 2b상 임상 시험 결과가 긍정적이며, 2상 시험을 통합한 96%의 임상 치유율을 보여주고, 치료 후 1개월 동안 100%의 지속적인 치유율을 기록한 반면, 반코마이신은 86%였습니다.
회사는 ibezapolstat의 3상 프로그램에 대해 EMA로부터 긍정적인 규제 지침을 확보했으며, 이는 FDA 요구 사항과 일치합니다. 재무 결과는 2024년 12월 31일 기준으로 현금 보유액이 $3.7 백만으로, 전년 대비 $7.5 백만에서 감소했음을 보여줍니다. 회사는 2024년에 ATM 금융을 통해 $6.6 백만을 모금했습니다.
2024년 4분기는 손실이 감소하여 순손실이 $2.8 백만 ($0.16 주당)으로, 2023년 4분기의 $5.1 백만 ($0.37 주당)과 비교됩니다. 2024년 전체 순손실은 $14.1 백만 ($0.87 주당)으로, 2023년의 $14.6 백만 ($1.15 주당)과 비교됩니다.
Acurx Pharmaceuticals (NASDAQ: ACXP) a annoncé ses résultats du quatrième trimestre et de l'année entière 2024. Les points forts incluent des résultats positifs des essais cliniques de phase 2b pour ibezapolstat, montrant un taux de guérison clinique de 96% dans les essais de phase 2 combinés, avec un taux de guérison soutenu de 100% jusqu'à un mois après le traitement, comparé à 86% pour la vancomycine.
L'entreprise a obtenu des conseils réglementaires positifs de l'EMA pour le programme de phase 3 d'ibezapolstat, en accord avec les exigences de la FDA. Les résultats financiers montrent une position de trésorerie de $3.7 millions au 31 décembre 2024, en baisse par rapport à $7.5 millions l'année précédente. L'entreprise a levé $6.6 millions grâce à un financement ATM en 2024.
Le quatrième trimestre de 2024 a montré des pertes réduites avec une perte nette de $2.8 millions ($0.16 par action) par rapport à $5.1 millions ($0.37 par action) au quatrième trimestre 2023. La perte nette pour l'année entière 2024 était de $14.1 millions ($0.87 par action) contre $14.6 millions ($1.15 par action) en 2023.
Acurx Pharmaceuticals (NASDAQ: ACXP) hat seine Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 bekannt gegeben. Zu den wichtigsten Highlights gehören positive Ergebnisse der Phase 2b klinischen Studie für ibezapolstat, die eine 96%ige klinische Heilungsrate in den kombinierten Phase 2 Studien zeigt, mit einer 100%igen nachhaltigen Heilungsrate bis einen Monat nach der Behandlung, im Vergleich zu 86% für Vancomycin.
Das Unternehmen erhielt eine positive regulatorische Anleitung von der EMA für das Phase 3 Programm von ibezapolstat, das mit den Anforderungen der FDA übereinstimmt. Die finanziellen Ergebnisse zeigen eine Liquiditätsposition von $3.7 Millionen zum 31. Dezember 2024, ein Rückgang von $7.5 Millionen im Vergleich zum Vorjahr. Das Unternehmen hat 2024 über ATM-Finanzierung $6.6 Millionen gesammelt.
Im vierten Quartal 2024 wurden reduzierte Verluste mit einem Nettoverlust von $2.8 Millionen ($0.16 pro Aktie) im Vergleich zu $5.1 Millionen ($0.37 pro Aktie) im vierten Quartal 2023 erzielt. Der Nettoverlust für das gesamte Jahr 2024 betrug $14.1 Millionen ($0.87 pro Aktie) im Vergleich zu $14.6 Millionen ($1.15 pro Aktie) im Jahr 2023.
- 96% clinical cure rate in Phase 2 trials for ibezapolstat
- 100% sustained cure rate through one month post-treatment
- Positive EMA and FDA alignment for Phase 3 program
- Reduced net loss per share from $1.15 in 2023 to $0.87 in 2024
- New Japanese patent granted for DNA polymerase IIIC inhibitors through 2039
- Cash position decreased 51% to $3.7M from $7.5M year-over-year
- Continued net losses of $14.1M in 2024
- Multiple dilutive financings including $2.5M offering in January 2025 and $1.1M in March 2025
Insights
Acurx Pharmaceuticals' Q4 and 2024 annual results present a mixed financial picture with some concerning metrics but positive clinical progress. The company's cash position declined significantly to
The net loss improved marginally to
The clinical data for ibezapolstat offers significant promise, with a
The scientific findings demonstrating ibezapolstat's microbiome-preserving properties could represent a meaningful commercial differentiation against current standard-of-care antibiotics for C. difficile infection, potentially reducing recurrence rates without requiring expensive microbiome therapeutics.
The clinical data for ibezapolstat is genuinely encouraging. The
The two newly published mechanistic studies in the Journal of Antimicrobial Agents and Chemotherapeutics provide critical scientific validation of ibezapolstat's differentiated mode of action. The in-silico study predicting microbiome-restorative potential explains the drug's selectivity via DNA pol IIIC enzyme targeting. This allows beneficial gut microbes to repopulate—a key factor in preventing C. difficile recurrence.
The head-to-head comparison against vancomycin, metronidazole, and fidaxomicin in a germ-free mouse model demonstrated ibezapolstat's more selective impact on gut microbiome diversity. This selective preservation of microbiome integrity could translate to lower recurrence rates in Phase 3 trials, addressing a major unmet need in CDI treatment where recurrence affects
The aligned regulatory guidance from both FDA and EMA streamlines the path to potential approval, reducing development risk. The Phase 3 program appears well-positioned based on consistent regulatory feedback, though the company will need additional capital to execute these trials. The Japanese patent for DNA polymerase IIIC inhibitors strengthens their long-term pipeline potential, particularly for ACX-375C targeting MRSA, VRE, and anthrax infections.
Highlights of the fourth quarter ended December 31, 2024, or in some cases shortly thereafter, include:
- In October 2024, we exhibited at ID Week in
Los Angeles , which was the annual scientific conference of the Infectious Diseases Society of America and where Drs. Garey and Eubank, from the University of Houston School of Pharmacy, presented a scientific poster showing that in the Phase 2b clinical trial, ibezapolstat had comparable clinical cure and sustained clinical cure rates and safety profile to vancomycin. As previously reported, the overall observed Clinical Cure rate in the combined Phase 2 trials (Ph2a and Ph2b) in patients with CDI was96% (25 out of 26 patients); AND100% (25 of 25) of ibezapolstat-treated patients in Phase 2 (again, Phase 2a + 2b) who had Clinical Cure at End of Treatment, (or EOT), remained cured through one month after EOT, as compared to86% (12 of 14) for the vancomycin patient group in Ph2b. Also, in a subset of ibezapolstat patients, 5 of 5 followed for 3 months after end of treatment (EOT) experienced no recurrence of infection. IBZ-treated patients showed decreased concentrations of fecal primary bile acids, and higher ratios of secondary to primary bile acids than vancomycin-treated patients.
According to Dr. Garey: "These exciting results demonstrate two properties of ibezapolstat which may contribute to its anti-recurrence effect. First, the preservation and restoration of beneficial bacterial classes in the gut provide resistance to recolonization by C. difficile. Second, these data, presented for the first time, indicate that these beneficial bacteria known to metabolize primary to secondary bile acids persist in ibezapolstat-treated patients providing another important mechanism to prevent recurrent CDI." - In November 2024, we announced Sponsorship and Participation in the Peggy Lillis Foundation Inaugural CDI Scientific Symposium and Presented an Ibezapolstat Ph2b Clinical Data Update.
- 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 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 2024 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, for that matter, 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. The second study, conducted by Dr. Trenton Wolfe, from the University ofMontana , 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
Fourth Quarter and Full Year 2024 Financial Results
Cash Position:
The Company ended the year with cash totaling
R&D Expenses:
Research and development expenses for the three months ended December 31, 2024 were
G&A Expenses:
General and administrative expenses for the three months ended December 31, 2024 were
Net Income/Loss:
The Company reported a net loss of
The Company had 17,030,686 shares outstanding as of December 31, 2024.
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, March 18, 2025 |
Time: | 8:00 a.m. ET |
Toll free ( | 1-877-790-1503; Conference ID: 13752142 |
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-positive 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, methicillin- resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug- resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen). Acurx's lead product candidate, ibezapolstat, for the treatment of C. difficile Infection is Phase 3 ready with plans in progress to begin international clinical trials next year. The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for treatment of inhaled anthrax is being planned in parallel.
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. BALANCE SHEETS AS OF DECEMBER 31, 2024 and 2023 | ||||||
December 31, | December 31, | |||||
2024 | 2023 | |||||
ASSETS | ||||||
CURRENT ASSETS | ||||||
Cash | $ | 3,706,713 | $ | 7,474,188 | ||
Other Receivable | 51,127 | 129,159 | ||||
Prepaid Expenses | 100,123 | 105,776 | ||||
TOTAL ASSETS | $ | 3,857,963 | $ | 7,709,123 | ||
LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||
CURRENT LIABILITIES | ||||||
Accounts Payable and Accrued Expenses | $ | 3,242,842 | $ | 3,042,438 | ||
TOTAL CURRENT LIABILITIES | 3,242,842 | 3,042,438 | ||||
TOTAL LIABILITIES | 3,242,842 | 3,042,438 | ||||
COMMITMENTS AND CONTINGENCIES | ||||||
SHAREHOLDERS' EQUITY | ||||||
Common Stock; 17,030,686 and 14,468,229 shares issued and outstanding at December 31, 2024 and December 31, 2023, respectively | 17,031 | 14,468 | ||||
Additional Paid-In Capital | 67,920,046 | 57,871,070 | ||||
Accumulated Deficit | (67,321,956) | (53,218,853) | ||||
TOTAL SHAREHOLDERS' EQUITY | 615,121 | 4,666,685 | ||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 3,857,963 | $ | 7,709,123 | ||
ACURX PHARMACEUTICALS, INC. STATEMENTS OF OPERATIONS YEARS ENDED DECEMBER 31, 2024 AND 2023 | |||||||
Years Ended | |||||||
December 31, | |||||||
2024 | 2023 | ||||||
OPERATING EXPENSES | |||||||
Research and Development | $ | 5,403,836 | $ | 6,043,597 | |||
General and Administrative | 8,699,267 | 8,534,171 | |||||
TOTAL OPERATING EXPENSES | 14,103,103 | 14,577,768 | |||||
NET LOSS | $ | (14,103,103) | $ | (14,577,768) | |||
LOSS PER SHARE | |||||||
Basic and diluted net loss per common share | $ | (0.87) | $ | (1.15) | |||
Weighted average common shares outstanding, basic and diluted | 16,163,366 | 12,671,572 | |||||
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SOURCE Acurx Pharmaceuticals, Inc.
FAQ
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