Staphylococcus Aureus Infections

STATEN ISLAND, N.Y., March 18, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("we" or "Acurx" or the "Company"), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today certain financial and operational results for the fourth quarter and full year ended December 31, 2023. Highlights of the fourth quarter ended December 31, 2023, or in some cases shortly thereafter, include: In October 2023, we ended enrollment in our Phase 2b clinical trial of ibezapolstat, our lead antibiotic candidate, for the treatment of patients with C. difficile infection, or CDI. In November 2023, we reported top-line data from the Phase 2b clinical trial, including overall results from the full Phase 2 study, demonstrating an ibezapolstat clinical cure rate at end of 10-days' oral treatment, or EOT, of 96% (25 of 26 patients) which included 100% cure in Phase 2a (10 of 10 patients) and 94% in Phase 2b (15 of 16 patients) compared with the vancomycin control arm of 100% (14 of 14 patients) at EOT. No safety concerns were reported in either arm of the Phase 2b clinical trial and ibezapolstat was well tolerated in all patients in both the Phase 2a open label trial and in the Phase 2b vancomycin-controlled segment. In consultation with its scientific advisors, the Company determined that based on review of aggregate blinded data the Phase 2b vancomycin-controlled trial segment was terminated early due to success showing high observed clinical cure rates with no emerging safety concerns. We also stated at that further data would be provided as they become available on secondary and exploratory endpoints from the Phase 2b trial segment, including sustained clinical cure data at 30 days after EOT, and Extended Clinical cure data up to 94 days as well as comparative data on the impact to the patient's microbiome. In December 2023, we announced the sustained clinical cure data. These data showed that in the Phase 2b clinical trial segment 100% or 15 out of 15 patients who were cured at EOT remained cured with no reinfection 30 days later while vancomycin experienced a reinfection rate of 14.3% (2 of 14 patients). In January 2024, the Company announced positive comparative microbiology and microbiome data for ibezapolstat in CDI patients from the Phase 2b clinical trial segment. Ibezapolstat outperformed vancomycin showing eradication of fecal C. difficile at Day 3 of treatment in 15 of 16 treated patients (94%), versus vancomycin which had eradication of C. difficile in 10 of 14 treated patients (71%). Additional data from this Phase 2b clinical trial showed ibezapolstat, but not vancomycin, consistently preserved and allowed regrowth of key gut bacterial species believed to confer health benefits including to prevent recurrence of CDI. The Company anticipates that additional data from the secondary and exploratory endpoints will provide further favorable separation between these two therapeutic options in our Phase 3 clinical trial program and ultimately in the marketplace, if approved. Additional analyses regarding other secondary and exploratory endpoints will be forthcoming as data become available. Having robust preclinical, clinical and manufacturing data-to-date, the Company submitted a formidable Information Package to FDA in February 2024 along with a Request for an End of Phase 2 Meeting which was granted by the FDA and is scheduled to occur in April. We anticipate discussing our Phase 3 clinical trial mandate at this meeting and would anticipate documented meeting minutes from FDA in the second quarter of 2024. The European Medicines Agency (or EMA) approved our application to be designated as a small to medium sized enterprise (or SME) in Europe in February 2024 which provides for certain benefits including fee reductions and other support from the EMA for seeking a Marketing Authorization for Europe. In October 2023, Dr. Kevin Garey presented on behalf of the Company at ID Week with selective spectrum of activity data from our Phase 2a clinical trial. Dr. Garey is Professor and Chair, University of Houston College of Pharmacy, and the Principal Investigator for microbiome aspects of our ibezapolstat clinical trial program. Also at ID Week, Bob DeLuccia, our Executive Chairman, presented our new class of novel DNA pol IIIC inhibitors in our pre-clinical pipeline at the symposium entitled, "New Antimicrobials in the Pipeline." In November 2023, the Company filed an amendment to its shelf registration statement with the SEC and launched a $17 million at-the-market equity offering program (or ATM), with Alliance Global Partners acting as sales agent to the Company. Proceeds from the ATM have been and, in the future, are expect to be used for general corporate purposes going forward including our planned Phase 3 clinical trial mandate. Fourth Quarter and Full Year 2023 Financial Results Cash Position: The Company ended the year with cash totaling $7.5 million, compared to $9.1 million as of December 31, 2022. Subsequent to year-end, the Company sold an additional 1,121,793 shares under its ATM financing program, with gross proceeds of approximately $4.5 million. R&D Expenses: Research and development expenses for the three months ended December 31, 2023 were $1.9 million compared to $1.4 million for the three months ended December 31, 2022. The increase was due to the timing of Phase 2b trial related costs and an increase in consulting costs. For the year ended December 31, 2023, research and development expenses were $6.0 million versus $4.8 million for the year ended December 31, 2022. The increase is due primarily to Phase 2b trial-related costs and an increase in consulting costs. G&A Expenses: General and administrative expenses for the three months ended December 31, 2023 were $3.2 million compared to $1.8 million for the three months ended December 31, 2022. The increase was due primarily to a $0.8 million increase in professional fees, a $0.1 million increase in share-based compensation, and a $0.3 million increase in employee compensation costs. For the year ended December 31, 2023, general and administrative expenses were $8.5 million versus $7.3 million for the year ended December 31, 2022. The amounts reflect an increase in professional fees of $0.5 million, an increase of $0.3 million in share-based compensation, and an increase of $0.3 million in employee compensation costs. Net Income/Loss: The Company reported a net loss of $5.1 million or $0.37 per diluted share for the three months ended December 31, 2023 compared to a net loss of $3.3 million or $0.28 per diluted share for the three months ended December 31, 2022, and a net loss of $14.6 million or $1.15 per share for the year ended December 31, 2023, compared to a net loss of $12.1 million or $1.12 per diluted share for the year ended December 31, 2022 for the reasons previously mentioned. The Company had 14,468,229 shares outstanding as of December 31, 2023. 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: 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 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 . 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: [email protected] SOURCE Acurx Pharmaceuticals, Inc.

VANCOUVER, BC, March 13, 2024 /PRNewswire/ - In a recent presentation to the US Biophysical Society in Philadelphia1, Asep Medical Holdings Inc. ("Asep Inc." or the "Company") (CSE: ASEP) (OTCQB: SEPSF) (FSE: JJ8) CEO Dr. Bob Hancock announced how the ground-breaking use of artificial intelligence (AI) has allowed the development of new and improved treatments for biofilm infections. Biofilms are communities of bacteria that infect surfaces and cause 65% of all infections. They are very hard to treat, highly resistant to all antibiotics and no FDA-approved treatment for biofilms has been developed. Asep Medical's peptides have very potent activity against biofilms and thus have the potential to replace current sub-optimal treatments, including physical removal and combinations of antibiotics. Neural network artificial intelligence (AI) methods were applied to predict improved peptides based on the company's extensive stock of proprietary peptides and, in company-sponsored studies, have been shown to enable the prediction of improved peptides with substantially higher activity against biofilms2. This has allowed the company to enhance both activity and ability to suppress inflammation (the primary pathology of biofilm infections) and to explore the diverse markets impacted by biofilms, which cost global health care an estimated $368 billion annually3. These markets include oral health (dental) care4, wounds5 and chronic rhinosinusitis6, all addressed by Asep peptides that show excellent activity in model infections. Asep's first-generation product will be an oral irrigant/rinse for preventing biofilm infections in the oral cavity, which can lead to infections and erosion of teeth and dental implants. Another use for AI technology (LASSO regression) is in the development of the SepsetER blood-based gene expression test that is preparing to enter 510(k) regulatory approval studies in the USA. This test was developed at the University of British Columbia (UBC) under the guidance of Prof. Robert E. W. Hancock and analyzes the dysfunctional immune responses involved in sepsis7. Artificial intelligence8,9 was used to identify the minimum set of genes involved in a process termed cellular reprogramming (one of the types of immune dysfunction in sepsis), and it was shown that the expression of just 6 genes can accurately predict whether a patient will acquire sepsis and associated multi-organ failure. "We have harnessed AI to diagnose sepsis. Sepsis is a severe disease responsible for one in five deaths worldwide1 and essentially all deaths from pandemic microbes like COVID-19," says Dr. Hancock, Chair and CEO of Asep Inc. "It is critical to identify sepsis as early as possible due to the 7.6% increased risk of death10 for every hour of delay in diagnosis and initiation of appropriate treatment. No conventional assay exists that accurately predicts sepsis onset in the first hours after a patient enters the hospital. Asep scientists have found that SepsetER can predict whether a patient will subsequently acquire sepsis in 9 out of 10 patients in the ICU and 7 of 10 patients in the emergency department, based on analysis of company and published data". AI was also used to simplify the extreme complexity7 of sepsis, which has limited treatments to date. In clinical studies of patients from 4 countries/4 continents published by the Lancet Journal EBioMedicine8 and the Nature Journal Scientific Reports9, LASSO regression AI methods were applied. Five groupings (endotypes) of patients were identified as showing major differences in the underlying immune defects in each group8. These endotypes could be assessed using simple gene assays that were 89-97% accurate8. "Deciphering the underlying immune defects of sepsis patients is key to devising precision treatments tailored to the specific type of sepsis in patients," stated Asep CSO Dr. Evan Haney, "This will form the basis of a second test in development." OVERCOMING ANTIBIOTIC FAILURE The failure of antibiotics11 due to delayed diagnosis of sepsis, the high prevalence of recalcitrant biofilm infections and increased antibiotic resistance, compounded by declining antibiotic discovery, are among society's most pressing health issues. As described above, Dr. Hancock and his team have applied AI to discover a host of antimicrobial peptides (strings of a dozen or so amino acids), representing a promising new class of antibiotics. Asep Inc. has adapted these AI methods to address antibiotic failure associated with biofilms (a multi-cellular growth state of bacteria adaptively resistant to conventional antibiotics)12,13. Dr. Hancock's team used peptide array technology to prepare large random peptide libraries created using the amino acid composition of the most active peptides. The resultant data was used with an AI technique called artificial neural networks to develop quantitative in-silico models of antibiotic activity2,12. Random tests proved remarkably effective in predicting the activity of 100,000 virtual peptides. The best peptides, representing the top quartile of predicted activities, were effective against a broad array of multidrug-resistant "Superbugs" with activities that were equal to or better than four highly used conventional antibiotics, more effective than the most advanced clinical candidate antimicrobial peptide, and protective against Staphylococcus aureus infections in animal models. Similar methods were used to derive excellent antibiofilm peptides. Asep is preparing to take the best of these peptides to the clinic. "We use AI daily as a valuable tool in the battle against antibiotic failure to solve problems that have defied conventional methods. While others are trying to figure out how AI can be best used, we are already using it with amazing success in diagnostics and therapeutics. Asep Inc. is dedicated to leveraging AI's power to improve human health," said Dr. Evan Haney, Chief Scientific Officer of Asep. ABOUT ASEP MEDICAL HOLDINGS INC. Asep Medical Holdings Inc. (asepmedical.com) is dedicated to addressing the global issue of antibiotic failure by developing novel solutions for significant unmet medical needs in human medicine. The Company is a consolidation of three existing private companies, all with technology in advanced development — Sepset Biosciences Inc. (proprietary diagnostic tools to enable the early and timely identification of sepsis), ABT Innovations Inc. (broad-spectrum therapeutic agents to address multi-drug resistant biofilm infections), and SafeCoat Medical Inc. (an antimicrobial peptide, anti-fouling medical device coating technology). Sepset Biosciences Inc. (sepset.ca) is developing a diagnostic technology that involves a patient gene expression signature that predicts the development of severe sepsis, one of the significant diseases leading to antibiotic failure, since antibiotics are the primary treatment for sepsis. Sepsis was responsible for nearly 20% of all deaths on the planet in 2017 and essentially all deaths due to COVID-19 and other pandemics. The SepsetER test is a blood-based gene expression assay that is straightforward to implement, and results are obtained in about an hour after taking a blood sample in the emergency room or intensive care unit. This proprietary diagnostic technology differs from current diagnostic tests in enabling the diagnosis of severe sepsis within 60 minutes of initiating the test. Bacterial culture, the gold standard, provides a diagnosis after ~15 hours but can be as long as three days. Asep Inc. believes its test will enable physicians to make critical early decisions regarding appropriate therapies and thus reduce overall morbidity and mortality due to sepsis. ABT Innovations Inc.'s (abtinnovations.ca) peptide technology covers a broad range of therapeutic applications, including bacterial biofilm infections (medical device infections, chronic infections, lung, bladder, wound, dental, skin, ear-nose and throat, sinusitis, orthopaedic, etc.), anti-inflammatories, anti-infective immune-modulators and vaccine adjuvants. The company is in the pre-clinical development phase with promising data. SafeCoat Medical Inc.'s (safecoatmedical.com) technology incorporates self-assembling biocompatible polymers that can be combined with conjugated antimicrobial peptides and applied to virtually any surface as stable antimicrobial and/or anti-fouling coatings. Of particular interest is the application of this versatile antimicrobial coating to various medical devices and implants that often become contaminated with biofilm infections. SafeCoat is optimizing methods to manufacture and apply these anti-bacterial coatings to a host of surfaces and can tailor the composition of the coating and associated peptide sequences for any desired application. FORWARD-LOOKING STATEMENTS — This news release contains certain "forward-looking statements" within the meaning of such statements under applicable securities law. Forward-looking statements are frequently characterized by words such as "anticipates," "plan," "continue," "expect," "project," "intend," "believe," "anticipate," "estimate," "may," "will," "potential," "proposed," "positioned" and other similar words, or statements that certain events or conditions "may" or "will" occur. These statements include but are not limited to the successful clinical testing of our Sepsis diagnostic test and its intended filing for regulatory approval; the Company not receiving regulatory approval as planned or at all; the undertaking of pre-clinical studies on our lead therapeutic, with the expectation that this will lead to fast-track clinical trials; the timeframe for diagnosis of sepsis with the company's products; the potential opportunities for the generation of revenue; the therapeutic benefits of the company's products; and other statements regarding the company's proposed business plans. Various assumptions were used in drawing conclusions or making the predictions contained in the forward-looking statements throughout this news release. Forward-looking statements are based on the opinions and estimates of management at the date the statements are made and are subject to a variety of risks including the risk that the company's products may not perform as expected; that the company may not receive the requisite regulatory approvals or results of testing; the Company's testing of the products may not be successful and approvals may not be obtained in the estimated timelines or at all; the company may not be able to generate revenue from its products as expected or at all; the market for the company's products may not be as described in this news release; and various other risk factors identified in the Asep Medical Inc.'s prospectus dated November 9, 2021, and in the company's management discussion and analysis, available for review under the Company's profile at and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Asep Medical Inc. is under no obligation and expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by applicable law. ENDNOTES SOURCE ASEP Medical Holdings Inc.

A person's age, sex and location are correlated with the chance that they have a bloodstream infection that is resistant to antibiotics, according to a new study. A person's age, sex and location are correlated with the chance that they have a bloodstream infection that is resistant to antibiotics, according to a new study published March 14th in PLOS Medicine by Gwenan Knight of the London School of Hygiene and Tropical Medicine, UK, and colleagues. Antimicrobial resistance (AMR), in which infections cannot be treated with antibiotics, is a major global public health threat. Little has been known about how the prevalence of resistance varies with age and sex even though antibiotic usage, changes in immune function, and exposure to high-risk settings are all linked to age and sex. In the new study, researchers analyzed data collected as part of routine surveillance between 2015 and 2019 on bloodstream infections in 944,520 individuals across 29 European countries. The team looked at which bacterial species were isolated and sent to the surveillance service, and which antibiotics were used to treat the infections. Distinct patterns in resistance prevalence by age were observed throughout Europe but varied across bacterial species. For most but not all bacteria, peaks in resistance were seen at the youngest and oldest ages. The occurrence of methicillin-resistant Staphylococcus aureus (MRSA) increased with age and the occurrence of aminopenicillin resistance in Escherichia coli decreased with age. Some antimicrobial resistance profiles peaked in middle-age; Pseudomonas aeruginosa was most likely to be resistant to several antibiotics around 30 years of age and, for women, the incidence of bloodstream infections due to E. coli peaked between ages 15 and 40. There were other important differences between sexes; in general, men had a higher risk of antimicrobial resistance than women. "These findings highlight important gaps in our knowledge of the epidemiology of antimicrobial resistance that are difficult to explain through known patterns of antibiotic exposure and healthcare contact," the authors say. "Our findings suggest that there may be value in considering interventions to reduce antimicrobial resistance burden that take into account important variations in antimicrobial resistance prevalence with age and sex." The authors add, "Our findings, that the prevalence of resistance in bloodstream infections across Europe varies substantially by age and sex, highlights important gaps in our knowledge of the spread and selection of AMR. In order for us to address this growing threat to public health, we now need data from a wider range of sources to determine the contribution that cultural versus natural history differences have in driving these patterns globally and the role that they play in the increasing rates of AMR being seen."