Acurx Pharmaceuticals, Inc. Reports Second Quarter 2024 Results and Provides Business Update

Rhea-AI Summary

Acurx Pharmaceuticals (NASDAQ: ACXP) reported Q2 2024 results and provided a business update. Key highlights include:

- Successful End-of-Phase 2 meeting with FDA, confirming Phase 3 readiness for ibezapolstat (IBZ) in treating C. difficile infection

- Presentation of Phase 2 data at scientific conferences

- EMA approval as SME, providing benefits for European marketing authorization

- New patent granted for IBZ, expiring in June 2042

- Q2 financials: $6.4M cash on hand, R&D expenses of $1.8M, G&A expenses of $2.3M, net loss of $4.1M ($0.26 per share)

- Ongoing preparations for international Phase 3 trials and regulatory submissions in EU, UK, Japan, and Canada

Positive

• Successful End-of-Phase 2 meeting with FDA, confirming Phase 3 readiness for ibezapolstat
• New patent granted for ibezapolstat, expiring in June 2042
• EMA approval as SME, providing benefits for European marketing authorization
• Ongoing preparations for international Phase 3 trials and regulatory submissions

Negative

• Net loss increased to $4.1M in Q2 2024 from $3.4M in Q2 2023
• Cash position decreased to $6.4M from $7.5M at end of 2023
• R&D expenses increased to $1.8M in Q2 2024 from $1.7M in Q2 2023
• G&A expenses increased to $2.3M in Q2 2024 from $1.7M in Q2 2023

Financial Analyst

Acurx Pharmaceuticals' Q2 2024 results reveal a mixed financial picture. The company's cash position decreased to $6.4 million from $7.5 million at the end of 2023, indicating ongoing cash burn. R&D expenses increased slightly to $1.8 million, while G&A expenses rose more significantly to $2.3 million. The net loss widened to $4.1 million ($0.26 per share) from $3.4 million ($0.28 per share) year-over-year.

Despite these financial challenges, the company's progress with ibezapolstat (IBZ) for C. difficile infection is promising. The successful End-of-Phase 2 meeting with FDA and advancement to Phase 3 trials are positive catalysts. The new patent grant until 2042 could provide long-term value. However, investors should monitor the company's cash position closely, as additional financing may be needed to support the Phase 3 trials.

Medical Research Analyst

The progress of ibezapolstat (IBZ) in treating C. difficile infection is highly encouraging. The FDA's agreement on key elements for Phase 3 trials and the NDA filing plan signifies strong clinical potential. The presentation of Phase 2 results at multiple scientific conferences, including ESCMID and the Anaerobe Society of the Americas, demonstrates growing interest in the scientific community.

The newly granted patent, specifically covering IBZ's ability to reduce infection recurrence and improve gut microbiome health, is a significant development. This could differentiate IBZ from existing treatments and potentially address a critical need in C. difficile management. The expansion of regulatory initiatives to the EU, UK, Japan and Canada also indicates a robust global strategy for IBZ's development.

Market Research Analyst

Acurx's market position in the antibiotics sector is strengthening. The EMA's SME designation provides strategic advantages for European market entry, including fee reductions and regulatory support. This could expedite IBZ's path to commercialization in a key market.

The company's presence at major scientific conferences throughout 2024 will likely increase visibility among key opinion leaders and potential partners. However, the competitive landscape for C. difficile treatments remains challenging. Investors should watch for upcoming Phase 3 trial results and any potential partnerships or licensing deals that could bolster Acurx's market position. The company's ability to secure additional funding without significant dilution will be important for maintaining shareholder value as it progresses towards potential commercialization.

STATEN ISLAND, N.Y., Aug. 9, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("we" or "Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today certain financial and operational results for the second quarter ended June 30, 2024. 

Highlights of the second quarter ended June 30, 2024, or in some cases shortly thereafter, include:

• In April 2024, we completed a successful End-of-Phase 2 Clinical Meeting with FDA and confirmed Phase 3 Readiness for ibezapolstat (IBZ) to enter Phase 3 clinical trials for the treatment of C. difficile infection. Agreement with FDA was reached on key elements to move forward with our international Phase 3 clinical trial program. Agreement was also reached with FDA on the complete non-clinical and clinical development plan for filing of a New Drug Application (NDA) for marketing approval. We've since continued activities to advance IBZ into international Phase 3 clinical trials for treatment of C. difficile Infection. In parallel, we're also preparing to submit requests for regulatory guidance to initiate clinical trials in the European Union, the United Kingdom, Japan and Canada.
  
  
  
• Also in April 2024, we attended the European Society of Microbiology and Infectious Disease (or ESCMID) scientific congress. Dr. Kevin Garey provided an oral presentation of our Phase 2 data entitled: "A Phase 2, Randomized, Double-Blind Study of Ibezapolstat Compared with Vancomycin for the Treatment of C. difficile Infection." Dr. Garey is Professor and Chair, University of Houston College of Pharmacy, and the Principal Investigator for microbiology and microbiome aspects of the IBZ clinical trial program and Acurx Scientific Advisory Board member. The oral presentation included additional analyses of clinical and microbiological data and is available on our website at www.acurxpharma.com. The complete Phase 2 results are being prepared for submission to a prominent scientific journal for publication. The oral presentation is available on our website at www.acurxpharma.com.
  
  
  
• In May 2024, we announced that the European Medicines Agency (or EMA) approved our application to be designated as a small to medium sized enterprise (or SME) in Europe which provides for certain benefits including fee reductions and other support from the EMA for seeking a Marketing Authorization for Europe.
  
  
  
• In July 2024, results from the IBZ Phase 2 clinical trial in patients with C. difficile Infection were presented at the 17th Biennial Congress of the Anaerobe Society of the Americas by Taryn A. Eubank, PharmD, BCIDP, Research Assistant Professor, University of Houston 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 IBZ 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 think 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.
  
  
  
• Throughout the rest of this year, we'll continue to roll out our Phase 2 results in either oral presentations or scientific posters (in some cases both), which will include results from new analyses as data become available, at various prominent scientific conferences including:
  • In September 2024, the World Antimicrobial Resistance conference in Philadelphia;
  • In September 2024, the 8th International C. difficile Symposium (or ICDS meeting) in Bled, Slovania, which is the premiere global venue for the review of C. difficile research; and
  • In October 2024, we will be presenting at the annual meeting of the Infectious Diseases Society of America (or ID Week) in Los Angeles.
    
    
    
• International Regulatory Initiatives will continue in 2H 2024.

Second Quarter of 2024 Financial Results

• Cash Position:
  The Company ended the quarter with cash totaling $6.4 million, compared to $7.5 million as of December 31, 2023. During the second quarter, the Company sold an additional 133,066 shares under its ATM financing program, with gross proceeds of approximately $0.3 million.
  
  
  
• R&D Expenses:
  Research and development expenses for the three months ended June 30, 2024 were $1.8 million compared to $1.7 million for the three months ended June 30, 2023. The increase was due primarily to an increase in manufacturing related costs during the quarter of $0.4 million, partially offset by a reduction in consulting fees of $0.3 million. For the six months ended June 30, 2024 research & development expenses were $3.4 million compared to $2.8 million for the six months ended June 30, 2023, an increase of $0.6 million primarily due to $0.8 million increase in manufacturing related costs offset by $0.2 million decrease in consulting fees.
  
  
  
• G&A Expenses:
  General and administrative expenses for the three months ended June 30, 2024 were $2.3 million compared to $1.7 million for the three months ended June 30, 2023, an increase of $0.6 million. The increase was primarily due to $0.3 million increase in professional fees and $0.2 million increase in non cash share-based compensation related costs. For the six months ended June 30, 2024, general and administrative expenses were $5.1 million compared to $3.6 million for the six months ended June 30, 2023, an increase of $1.5 million. The increase was primarily due to $1.0 million increase in professional fees, $0.4 million increase in non cash share-based compensation costs and $0.1 million increase in legal costs
  
  
  
• Net Income/Loss:
  The Company reported a net loss of $4.1 million or $0.26 per diluted share for the three months ended June 30, 2024 compared to a net loss of $3.4 million or $0.28 per diluted share for the three months ended June 30, 2023, and a net loss of $8.5 million or $0.54 per share for the six months ended June 30, 2024, compared to a net loss of $6.3 million or $0.53 per share for the reasons previously mentioned.
  
  
  The Company had 15,996,168 shares outstanding as of June 30, 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:	Friday, August 9, 2024
Time:	8:00 a.m. ET
Toll free (U.S. and International):	877-790-1503
Conference ID:	13747936

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 U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.

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 

 

ITEM 1. CONDENSED INTERIM FINANCIAL STATEMENTS.
ACURX PHARMACEUTICALS, INC. CONDENSED INTERIM BALANCE SHEETS
		June 30,			December 31,
		2024			2023
		(unaudited)			(Note 2)
ASSETS
CURRENT ASSETS
Cash		$	6,360,858		$	7,474,188
Other Receivable			51,127			129,159
Prepaid Expenses			168,407			105,776
TOTAL ASSETS		$	6,580,392		$	7,709,123
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES
Accounts Payable and Accrued Expenses		$	3,152,917		$	3,042,438
TOTAL CURRENT LIABILITIES			3,152,917			3,042,438
TOTAL LIABILITIES			3,152,917			3,042,438
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS' EQUITY
Common Stock; $.001 par value, 200,000,000 shares authorized, 15,996,168 and 14,468,229 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively			15,996			14,468
Additional Paid-In Capital			65,130,047			57,871,070
Accumulated Deficit			(61,718,568)			(53,218,853)
TOTAL SHAREHOLDERS' EQUITY			3,427,475			4,666,685
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY		$	6,580,392		$	7,709,123

 

ACURX PHARMACEUTICALS, INC. CONDENSED INTERIM STATEMENTS OF OPERATIONS
		Three Months Ended						Six Months Ended
		June 30,						June 30,
		2024			2023			2024			2023
		(unaudited)			(unaudited)			(unaudited)			(unaudited)
OPERATING EXPENSES
Research and Development		$	1,825,582		$	1,736,386		$	3,380,593		$	2,751,969
General and Administrative			2,296,244			1,708,854			5,119,122			3,596,228
TOTAL OPERATING EXPENSES			4,121,826			3,445,240			8,499,715			6,348,197
NET LOSS		$	(4,121,826)		$	(3,445,240)		$	(8,499,715)		$	(6,348,197)
LOSS PER SHARE
Basic and diluted net loss per common share		$	(0.26)		$	(0.28)		$	(0.54)		$	(0.53)
Weighted average common shares outstanding, basic and diluted			15,824,654			12,186,481			15,677,426			11,914,449

 

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SOURCE Acurx Pharmaceuticals, Inc.

FAQ

What were Acurx Pharmaceuticals' (ACXP) Q2 2024 financial results?

Acurx reported a net loss of $4.1M or $0.26 per share, with R&D expenses of $1.8M and G&A expenses of $2.3M. The company ended the quarter with $6.4M in cash.

What progress did Acurx (ACXP) make with ibezapolstat in Q2 2024?

Acurx completed a successful End-of-Phase 2 meeting with FDA, confirming Phase 3 readiness for ibezapolstat in treating C. difficile infection. The company is preparing for international Phase 3 trials.

Did Acurx Pharmaceuticals (ACXP) receive any new patents in Q2 2024?

Yes, Acurx was granted a new patent for ibezapolstat in July 2024, specifically for treating C. difficile infection while reducing recurrence and improving gut microbiome health. The patent expires in June 2042.

What regulatory progress did Acurx (ACXP) make in Europe during Q2 2024?

In May 2024, the European Medicines Agency (EMA) approved Acurx's application to be designated as a small to medium-sized enterprise (SME) in Europe, providing benefits for seeking marketing authorization.