Acurx Pharmaceuticals, Inc. Reports Third Quarter 2024 Results and Provides Business Update
Acurx Pharmaceuticals (NASDAQ: ACXP) reported Q3 2024 financial results and business updates. The company ended Q3 with $5.8 million in cash, down from $7.5 million in December 2023. Q3 net loss was $2.8 million ($0.17 per share), compared to $3.1 million ($0.24 per share) in Q3 2023. Key developments include FDA submission for CMC meeting to commence Phase 3 trials, new patent grant for ibezapolstat extending to 2042, and positive Phase 2 trial results presentation showing comparable efficacy to vancomycin. The company raised $1.6 million through ATM financing during the quarter.
Acurx Pharmaceuticals (NASDAQ: ACXP) ha riportato i risultati finanziari del terzo trimestre 2024 e aggiornamenti aziendali. L'azienda ha chiuso il terzo trimestre con 5,8 milioni di dollari in contanti, rispetto ai 7,5 milioni di dollari di dicembre 2023. La perdita netta del terzo trimestre è stata di 2,8 milioni di dollari (0,17 dollari per azione), rispetto ai 3,1 milioni di dollari (0,24 dollari per azione) del terzo trimestre 2023. Tra i principali sviluppi vi sono la presentazione all'FDA per una riunione CMC per avviare i trial di fase 3, il nuovo brevetto concesso per ibezapolstat valido fino al 2042 e la presentazione di risultati positivi dei trial di fase 2 che mostrano un'efficacia comparabile a quella della vancomicina. L'azienda ha raccolto 1,6 milioni di dollari tramite finanziamento ATM durante il trimestre.
Acurx Pharmaceuticals (NASDAQ: ACXP) informó los resultados financieros del tercer trimestre de 2024 y actualizaciones comerciales. La compañía terminó el tercer trimestre con 5,8 millones de dólares en efectivo, disminuyendo de 7,5 millones de dólares en diciembre de 2023. La pérdida neta del tercer trimestre fue de 2,8 millones de dólares (0,17 dólares por acción), en comparación con 3,1 millones de dólares (0,24 dólares por acción) en el tercer trimestre de 2023. Los desarrollos clave incluyen la presentación a la FDA para una reunión de CMC que dará inicio a los ensayos de fase 3, la concesión de nueva patente para ibezapolstat que se extiende hasta 2042, y la presentación de resultados positivos de ensayos de fase 2 que muestran una eficacia comparable a la de la vancomicina. La compañía recaudó 1,6 millones de dólares a través de financiamiento ATM durante el trimestre.
Acurx Pharmaceuticals (NASDAQ: ACXP)는 2024년 3분기 재무 결과와 사업 업데이트를 발표했습니다. 회사는 2023년 12월 7.5백만 달러에서 감소한 580만 달러의 현금을 보유하며 3분기를 마감했습니다. 3분기 순손실은 280만 달러 (주당 0.17 달러)로, 2023년 3분기의 310만 달러(주당 0.24 달러)와 비교됩니다. 주요 개발 사항으로는 CMC 회의에 대한 FDA 제출을 통해 3상 시험을 시작하고, 2042년까지 연장되는 ibezapolstat에 대한 새로운 특허 부여, 그리고 반코마이신과 유사한 효능을 보여주는 2상 시험 결과 발표가 포함됩니다. 이 회사는 분기 동안 ATM을 통해 160만 달러를 모금했습니다.
Acurx Pharmaceuticals (NASDAQ: ACXP) a rapporté les résultats financiers du troisième trimestre 2024 et des mises à jour commerciales. L'entreprise a terminé le troisième trimestre avec 5,8 millions de dollars en espèces, en baisse par rapport à 7,5 millions de dollars en décembre 2023. La perte nette du troisième trimestre était de 2,8 millions de dollars (0,17 dollar par action), comparativement à 3,1 millions de dollars (0,24 dollar par action) au troisième trimestre 2023. Les développements clés incluent la soumission à la FDA pour une réunion de CMC pour commencer les essais de phase 3, un nouveau brevet accordé pour ibezapolstat valable jusqu'en 2042, et la présentation de résultats positifs d'essais de phase 2 montrant une efficacité comparable à celle de la vancomycine. L'entreprise a levé 1,6 million de dollars par le biais d'un financement ATM durant le trimestre.
Acurx Pharmaceuticals (NASDAQ: ACXP) hat die finanziellen Ergebnisse für das dritte Quartal 2024 und Unternehmensupdates veröffentlicht. Das Unternehmen schloss das dritte Quartal mit 5,8 Millionen Dollar in bar, ein Rückgang von 7,5 Millionen Dollar im Dezember 2023. Der Nettoverlust im dritten Quartal betrug 2,8 Millionen Dollar (0,17 Dollar pro Aktie), verglichen mit 3,1 Millionen Dollar (0,24 Dollar pro Aktie) im dritten Quartal 2023. Zu den wichtigen Entwicklungen gehören die Einreichung bei der FDA für eine CMC-Sitzung zur Aufnahme der Phase-3-Studien, die Gewährung eines neuen Patents für ibezapolstat, das bis 2042 gültig ist, sowie die Präsentation positiver Phase-2-Studienergebnisse, die eine vergleichbare Wirksamkeit wie Vancomycin zeigen. Das Unternehmen hat im Quartal 1,6 Millionen Dollar durch ATM-Finanzierung gesammelt.
- New patent granted for ibezapolstat extending to 2042
- Phase 2 trial results showed comparable efficacy to vancomycin
- Successful ATM financing raised $1.6 million
- Reduced net loss per share from $0.24 to $0.17 year-over-year
- Cash position decreased from $7.5M to $5.8M since December 2023
- Net loss of $2.8 million in Q3 2024
- Increased nine-month net loss to $11.3M from $9.5M year-over-year
- R&D expenses increased to $4.6M from $4.1M for nine months YoY
Insights
The Q3 results reveal concerning financial metrics. Cash position dropped to
R&D expenses remained relatively stable at
The ibezapolstat Phase 2 trial data shows promising clinical outcomes, particularly in preventing recurrence. The newly granted patent through 2042 strengthens the company's competitive position. The advancement toward Phase 3 trials, pending FDA CMC meeting, represents significant progress in the development pipeline.
The expansion into anthrax treatment through ACX-375 DNA pol IIIC analogues opens potential biodefense opportunities. The positive bile acid profile data presented at IDWeek suggests potential advantages over vancomycin in gut microbiome preservation, which could differentiate ibezapolstat in the CDI treatment landscape.
Highlights of the third quarter ended September 30, 2024, or in some cases shortly thereafter, include:
- In July 2024, results from the ibezapolstat (IBZ) Phase 2 clinical trial in patients with C. difficile Infection (CDI) were presented at the 17th Biennial Congress of the Anaerobe Society of the
Americas by Taryn A. Eubank, PharmD, BCIDP, Research Assistant Professor, University ofHouston College of Pharmacy delivered an oral presentation entitled: "Clinical Efficacy of Ibezapolstat in CDI: Results from Phase 2 trials." - Also in July 2024, and very timely given our late-stage development progress, the USPTO (United States Patent and Trademark Office) granted Acurx a new patent for ibezapolstat which specifically encompasses the "treatment of C. difficile Infection while reducing recurrence of infection and improving the health of the gut microbiome". This patent expires in June 2042 and we believe will provide an important downstream competitive advantage.
- In August 2024, we submitted our request to FDA for a meeting to review our manufacturing processes and specifications for drug substance and final product and packaging (a "CMC Meeting") in order to commence Phase 3 clinical trials. This FDA submission is customary and follows our successful End of Ph2 clinical meeting with FDA which confirmed our Ph3 clinical trial readiness. We anticipate convening a meeting with FDA regarding CMC in the fourth quarter.
- In September 2024, a presentation was given by Executive Chairman, Bob DeLuccia, at the World Antimicrobial Resistance Scientific Congress held in
Philadelphia . In his presentation at the Innovation Showcase session, he highlighted that we have a complete roadmap, not only for the required components of our phase 3 clinical program, but also what's required for ultimate filing of an NDA (or New Drug Application) which is to be followed by submissions for Marketing Authorizations in other countries around the world. He also presented an update on the Company's preclinical GPSS® (Gram Positive Selective Spectrum) program for systemic oral and IV treatment of other gram-positive infections including, MRSA, VRE and DRSP. - Also in September 2024, we participated at the 8th Annual C. Difficile Symposium (or ICDS) in Bled,
Slovenia , which is the premier global scientific venue for the review of C. Difficile research. At the ICDS Meeting, two presentations were made on behalf of the Company. - Additionally in September 2024, we announced that selected ACX-375 DNA pol IIIC analogues demonstrated in vitro activity against B. anthracis (or Anthrax), which is a Bioterrorism Category A pathogen, including activity against ciprofloxacin-resistant Anthrax. This work was performed at two independent qualified laboratories including the University of
Florida . Planning is underway for an Anthrax bioterrorism development program. - In October 2024, we participated at IDWeek in
Los Angeles , the annual scientific conference of the Infectious Diseases Society of America. Drs. Kevin Garey and Taryn Eubank 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. Also, 5 of 5 ibezapolstat patients who were followed for 3 months after end of treatment (EOT) experienced no recurrence. Ibezapolstat-treated patients showed decreased concentrations of fecal primary bile acids, and higher ratios of secondary to primary bile acids than vancomycin-treated patients. - International regulatory filing initiatives will continue in Q4 2024.
Third Quarter 2024 Financial Results
- Cash Position:
The Company ended the quarter with cash totaling$5.8 million $7.5 million $1.6 million - R&D Expenses:
Research and development expenses for the three months ended September 30, 2024 were$1.2 million $1.3 million $0.1 million $0.2 million $4.6 million $4.1 million $0.5 million $0.9 million $0.4 million - G&A Expenses:
General and administrative expenses for the three months ended September 30, 2024 were$1.6 million $1.8 million $0.2 million $0.2 million $0.1 million $0.5 million $6.7 million $5.4 million $1.3 million $1.1 million $0.2 million - Net Income/Loss:
The Company reported a net loss of$2.8 million $0.17 $3.1 million $0.24 $11.3 million $0.71 $9.5 million $0.77
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: | Wednesday, November 13, 2024 |
Time: | 8:00 a.m. ET |
Toll free ( | 877-790-1503 |
Conference ID: | 13749688 |
About Ibezapolstat
Ibezapolstat is the Company's lead antibiotic candidate preparing to advance 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, methicillin-resistant 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, 2023, 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 | ||||||
September 30, | December 31, | |||||
2024 | 2023 | |||||
(unaudited) | (Note 2) | |||||
ASSETS | ||||||
CURRENT ASSETS | ||||||
Cash | $ | 5,762,564 | $ | 7,474,188 | ||
Other Receivable | 97,373 | 129,159 | ||||
Prepaid Expenses | 122,822 | 105,776 | ||||
TOTAL ASSETS | $ | 5,982,759 | $ | 7,709,123 | ||
LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||
CURRENT LIABILITIES | ||||||
Accounts Payable and Accrued Expenses | $ | 3,318,765 | $ | 3,042,438 | ||
TOTAL CURRENT LIABILITIES | 3,318,765 | 3,042,438 | ||||
TOTAL LIABILITIES | 3,318,765 | 3,042,438 | ||||
COMMITMENTS AND CONTINGENCIES | ||||||
SHAREHOLDERS' EQUITY | ||||||
Common Stock; | 16,770 | 14,468 | ||||
Additional Paid-In Capital | 67,187,389 | 57,871,070 | ||||
Accumulated Deficit | (64,540,165) | (53,218,853) | ||||
TOTAL SHAREHOLDERS' EQUITY | 2,663,994 | 4,666,685 | ||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 5,982,759 | $ | 7,709,123 | ||
ACURX PHARMACEUTICALS, INC. | |||||||||||||
CONDENSED INTERIM STATEMENTS OF OPERATIONS | |||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||
September 30, | September 30, | ||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||
(unaudited) | (unaudited) | (unaudited) | (unaudited) | ||||||||||
OPERATING EXPENSES | |||||||||||||
Research and Development | $ | 1,198,184 | $ | 1,348,985 | $ | 4,578,777 | $ | 4,100,954 | |||||
General and Administrative | 1,623,413 | 1,765,996 | 6,742,535 | 5,362,224 | |||||||||
TOTAL OPERATING EXPENSES | 2,821,597 | 3,114,981 | 11,321,312 | 9,463,178 | |||||||||
NET LOSS | $ | (2,821,597) | $ | (3,114,981) | $ | (11,321,312) | $ | (9,463,178) | |||||
LOSS PER SHARE | |||||||||||||
Basic and diluted net loss per common | $ | (0.17) | $ | (0.24) | $ | (0.71) | $ | (0.77) | |||||
Weighted average common shares | 16,363,473 | 13,005,128 | 15,907,778 | 12,282,004 | |||||||||
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SOURCE Acurx Pharmaceuticals, Inc.
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