Company History and Business Overview
Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) is a late-stage biopharmaceutical company developing a new class of small-molecule antibiotics for difficult-to-treat bacterial infections. Formed in 2017, the company has made significant strides in advancing its lead candidate, ibezapolstat, through clinical trials for the treatment of Clostridioides difficile infection (CDI).
Acurx was founded in July 2017 and commenced operations in February 2018. The company was formed to develop a novel class of antibiotics that address serious or life-threatening bacterial infections. In February 2018, Acurx acquired the rights to its lead product candidate, ibezapolstat, from GLSynthesis, Inc.
Since its inception, Acurx has been primarily focused on performing research and development activities related to the development of ibezapolstat and raising funds through equity offerings to support these activities. The company faced early challenges in getting ibezapolstat into the clinic, having to successfully complete preclinical studies and obtain regulatory approval to initiate clinical trials.
In March 2020, the World Health Organization declared the COVID-19 outbreak a global pandemic. Acurx’s clinical trial operations were directly and indirectly impacted by the pandemic, but the company has navigated these challenges and continues to make progress with its clinical development programs.
Acurx has funded its operations primarily through equity issuances. The company completed its initial public offering in June 2021, raising approximately $14.8 million in net proceeds. Prior to the IPO, Acurx had raised additional funds through private equity financings since its formation in 2017. In July 2022 and May 2023, Acurx raised additional funds through registered direct offerings and concurrent private placements, generating net proceeds of $3.7 million and $3.5 million, respectively. The company also entered into an at-the-market (ATM) financing program in November 2023, under which it has raised approximately $8.6 million in net proceeds as of September 30, 2024.
As of September 30, 2024, Acurx had a cash balance of $5.8 million, which the company believes will not be sufficient to meet its anticipated cash requirements for at least 12 months from the issuance of the condensed interim financial statements for the period ended September 30, 2024. The company is actively exploring various funding options, including partnerships, government grants, and additional equity or debt financing, to support the continued development of its product candidates.
Financial Performance
Acurx is a clinical-stage company and has not generated any revenue from product sales to date. The company has incurred significant net losses since its inception, reporting a net loss of $11.3 million for the nine months ended September 30, 2024, compared to a net loss of $9.5 million for the same period in 2023.
Research and development expenses for the nine months ended September 30, 2024, were $4.6 million, an increase of $0.5 million compared to the same period in 2023. This increase was primarily due to a $0.9 million rise in manufacturing-related costs, partially offset by a $0.4 million decrease in consulting fees.
General and administrative expenses for the nine months ended September 30, 2024, were $6.7 million, an increase of $1.3 million compared to the same period in 2023. The increase was primarily attributable to a $1.1 million rise in professional fees and a $0.2 million increase in legal costs.
For the most recent fiscal year (2023), Acurx reported a net loss of $14,577,768. The company’s operating cash flow (OCF) and free cash flow (FCF) for 2023 were both negative $9,800,885. In the most recent quarter (Q3 2024), Acurx reported a net loss of $2,821,597, with OCF and FCF both at negative $8,127,089,786.
Liquidity
Acurx’s balance sheet as of September 30, 2024, showed $5.8 million in cash and cash equivalents, compared to $7.5 million as of December 31, 2023. The company’s working capital as of September 30, 2024, was $2.7 million.
The company’s liquidity position is characterized by a current ratio and quick ratio of 1.80. Acurx does not have any debt, resulting in a debt-to-equity ratio of 0. The company does not appear to have any credit facilities or lines of credit available.
Ibezapolstat: Acurx’s Lead Antibiotic Candidate
Ibezapolstat is Acurx’s lead antibiotic candidate, which the company is developing for the treatment of CDI. CDI is a serious and potentially life-threatening bacterial infection that the U.S. Centers for Disease Control and Prevention (CDC) categorizes as an urgent threat and calls for new classes of antibiotics.
Acurx’s research and development efforts have been focused on advancing ibezapolstat through clinical trials. In November 2023, the company announced positive top-line results from the Phase 2b segment of its Phase 2 clinical trial of ibezapolstat in patients with CDI. The observed Clinical Cure rate in the per protocol population was 94% in the ibezapolstat arm and 100% in the vancomycin arm.
Further analysis of the secondary and exploratory endpoints from the Phase 2b segment showed that 100% of the ibezapolstat-treated patients who achieved Clinical Cure at the end of treatment remained free of CDI recurrence through one month after the end of treatment, for a Sustained Clinical Cure rate of 100%. In comparison, 2 out of 14 patients (14%) treated with vancomycin experienced recurrent infection within one month after the end of treatment.
In September 2024, Acurx presented additional data from the Phase 2b trial at the International C. difficile Symposium (ICDS) in Bled, Slovenia. The data showed that ibezapolstat outperformed vancomycin in eradicating fecal C. difficile at Day 3 of treatment and consistently preserved and allowed regrowth of key gut bacterial species believed to confer health benefits, including to prevent recurrence of CDI.
Ibezapolstat has received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the U.S. Food and Drug Administration (FDA) for the treatment of CDI. Acurx is now preparing to advance ibezapolstat into international Phase 3 clinical trials for the treatment of CDI.
The company has provided details on its planned Phase III clinical trial program for ibezapolstat. Acurx plans to conduct two Phase III registration trials internationally, with approximately 150 trial sites and 450 patients per trial, for a total of 900 patients. The Phase III trials will be 1:1 randomized against oral vancomycin for a 10-day treatment period. The primary and secondary endpoints will be identical to the Phase IIb clinical trial endpoints. Acurx has noted that they have the flexibility to conduct the Phase III trials sequentially rather than simultaneously, due to the 10 years of regulatory exclusivity they would receive upon FDA approval, as well as similar advantages in Europe.
Expanding Pipeline: ACX-375C and Anthrax Program
In addition to ibezapolstat, Acurx has an early-stage pipeline of antibiotic product candidates with the same previously unexploited mechanism of action, which has established proof of concept in animal studies. This pipeline includes ACX-375C, a potential oral and parenteral treatment targeting Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), and drug-resistant Streptococcus pneumoniae (DRSP).
More recently, Acurx announced that selected ACX-375C analogues demonstrated in vitro activity against Anthrax (Bacillus anthracis), a Bioterrorism Category A pathogen, including activity against ciprofloxacin-resistant Anthrax. The company is now planning for an Anthrax bioterrorism development program. Acurx is in the early, preclinical stages of developing ACX-375 for the treatment of Anthrax, with independent research showing in vitro activity against Anthrax, including against ciprofloxacin-resistant Anthrax.
Regulatory Landscape and Partnerships
Acurx is actively engaging with regulatory authorities to advance its clinical development programs. The company has already had a successful End-of-Phase 2 meeting with the FDA, which confirmed the Phase 3 clinical trial readiness for ibezapolstat. Acurx is now preparing to submit requests for guidance to initiate clinical trials in the European Union, the United Kingdom, Japan, and Canada for ibezapolstat.
In addition to its regulatory efforts, Acurx is exploring partnership opportunities to support the further development and potential commercialization of its product candidates. The company has active dialogues with several companies in Europe, Japan, and South America regarding potential licensing and co-development agreements. Acurx is also in discussions with government agencies regarding potential non-dilutive funding sources for its clinical programs.
Challenges and Risks
Acurx, like many other clinical-stage biopharmaceutical companies, faces several challenges and risks that could impact its future success. These include the inherent risks associated with drug development, such as the potential for clinical trial failures, regulatory hurdles, and competition from other antibiotic therapies.
The company’s ability to secure additional funding to support its operations is also a key risk factor. As of September 30, 2024, Acurx had $5.8 million in cash, which the company believes will not be sufficient to meet its anticipated cash requirements for at least 12 months. Failure to obtain additional funding could delay or halt the company’s clinical development programs.
Furthermore, Acurx’s reliance on third-party manufacturers and contractors for the production and testing of its product candidates introduces supply chain and operational risks that could disrupt the company’s development timeline.
Outlook and Conclusion
Acurx is a late-stage biopharmaceutical company with a promising lead candidate, ibezapolstat, for the treatment of CDI. The company’s recent clinical trial results have demonstrated ibezapolstat’s potential to be a more effective and safer alternative to the current standard of care, vancomycin.
As Acurx prepares to advance ibezapolstat into international Phase 3 clinical trials, the company will need to secure additional funding to support its operations and development activities. The successful execution of its regulatory and partnership strategies will be crucial in determining the company’s ability to bring ibezapolstat and its other pipeline candidates to market.
While Acurx faces the inherent challenges and risks associated with drug development, the company’s focus on addressing the growing threat of antimicrobial resistance and its promising lead candidate suggest that it is well-positioned to potentially make a significant impact in the pharmaceutical industry.
Acurx’s research and development pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile (C. difficile), methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP). The company’s lead product candidate, ibezapolstat, has a novel mechanism of action that targets the DNA polymerase IIIC (pol IIIC) enzyme, which is necessary for the replication of the DNA of certain Gram-positive bacteria like C. difficile. This enzyme has not been previously targeted by other antibiotics used to treat CDI.
In the third quarter of 2024, Acurx continued to advance the development of ibezapolstat, including presenting positive results from the Phase 2 clinical trial at scientific conferences, receiving a new patent from the USPTO related to the use of ibezapolstat to treat CDI while reducing recurrence and improving gut microbiome, submitting a request to the FDA for a meeting to review the company’s manufacturing processes and specifications for ibezapolstat ahead of planned Phase 3 trials, and presenting updates on the company’s preclinical Gram-positive Selective Spectrum (GPSS) program, including data showing activity of ACX-375C analogues against anthrax.
As a small cap company, Acurx appears to currently only operate in the US market. The company has not reported any major scandals, short seller reports, or CEO departures. With its promising pipeline and advancing clinical programs, Acurx remains focused on addressing the critical need for new antibiotics to combat antimicrobial resistance.
Disclaimer: This article is for informational purposes only. It does not constitute financial, legal, or other types of advice. While every effort has been made to ensure the accuracy of the information presented here, the author and the publisher do not make any guarantees about the completeness, reliability, and accuracy of this information.