• Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • Settings
  • RSS Feeds
Quantisnow Logo
  • Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • Settings
  • RSS Feeds
Dashboard
    Quantisnow Logo

    © 2025 quantisnow.com
    Democratizing insights since 2022

    Services
    Live news feedsRSS FeedsAlerts
    Company
    AboutQuantisnow PlusContactJobs
    Legal
    Terms of usePrivacy policyCookie policy

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

    11/13/24 7:00:00 AM ET
    $ACXP
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $ACXP alert in real time by email

    STATEN ISLAND, N.Y., Nov. 13, 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 third quarter ended September 30, 2024.

    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 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 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, compared to $7.5 million as of December 31, 2023. During the third quarter, the Company raised additional proceeds under its ATM financing program, with gross proceeds of approximately $1.6 million.



    • R&D Expenses:

      Research and development expenses for the three months ended September 30, 2024 were $1.2 million compared to $1.3 million for the three months ended September 30, 2023. The decrease was due primarily to an increase in manufacturing related costs during the quarter of $0.1 million, offset by a reduction in consulting fees of $0.2 million. For the nine months ended September 30, 2024 research & development expenses were $4.6 million compared to $4.1 million for the nine months ended September 30, 2023, an increase of $0.5 million primarily due to $0.9 million increase in manufacturing related costs, offset by $0.4 million decrease in consulting fees.



    • G&A Expenses:

      General and administrative expenses for the three months ended September 30, 2024 were $1.6 million compared to $1.8 million for the three months ended September 30, 2023, a decrease of $0.2 million. The decrease was primarily due to $0.2 million increase in professional fees, a $0.1 million increase in compensation costs, offset by a $0.5 million decrease in non cash share-based compensation related costs. For the nine months ended September 30, 2024, general and administrative expenses were $6.7 million compared to $5.4 million for the nine months ended September 30, 2023, an increase of $1.3 million. The increase was primarily due to $1.1 million increase in professional fees and a $0.2 million increase in legal costs.



    • Net Income/Loss:

      The Company reported a net loss of $2.8 million or $0.17 per diluted share for the three months ended September 30, 2024 compared to a net loss of $3.1 million or $0.24 per diluted share for the three months ended September 30, 2023, and a net loss of $11.3 million or $0.71 per share for the nine months ended September 30, 2024, compared to a net loss of $9.5 million or $0.77 per share for the nine months ended September 30, 2023 for the reasons previously mentioned. The Company had 16,770,378 shares outstanding as of September 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:

    Wednesday, November 13, 2024

    Time:

    8:00 a.m. ET

    Toll free (U.S. and International):

    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 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: [email protected]

     

    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; $.001 par value, 200,000,000 shares authorized,

    16,770,378 and 14,468,229 shares issued and outstanding at

    September 30, 2024 and December 31, 2023, respectively





    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

    share



    $

    (0.17)



    $

    (0.24)



    $

    (0.71)



    $

    (0.77)































    Weighted average common shares

    outstanding, basic and diluted





    16,363,473





    13,005,128





    15,907,778





    12,282,004



     

    Cision View original content:https://www.prnewswire.com/news-releases/acurx-pharmaceuticals-inc-reports-third-quarter-2024-results-and-provides-business-update-302303717.html

    SOURCE Acurx Pharmaceuticals, Inc.

    Get the next $ACXP alert in real time by email

    Chat with this insight

    Save time and jump to the most important pieces.

    Recent Analyst Ratings for
    $ACXP

    DatePrice TargetRatingAnalyst
    11/29/2021$12.00Buy
    Maxim Group
    More analyst ratings

    $ACXP
    Press Releases

    Fastest customizable press release news feed in the world

    See more
    • Acurx Pharmaceuticals, Inc. Reports First Quarter Results and Provides Business Update

      STATEN ISLAND, N.Y., May 13, 2025 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP) ("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 first quarter ended March 31, 2025.   Highlights of the first quarter ended March 31, 2025, or in some cases shortly thereafter, include: In January 2025, the Company announced it had closed a $2.5 million registered direct offering priced at the market under Nasdaq rules.Also in January 2025, we announced that we received positive regulatory guidance from the European Medicines Agency (E

      5/13/25 7:01:00 AM ET
      $ACXP
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Acurx Pharmaceuticals to Discuss First Quarter 2025 Financial Results on May 13, 2025 Conference Call and Provide Business Update

      STATEN ISLAND, N.Y., April 30, 2025 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP) ("Acurx" or the "Company"), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today that the Company will discuss its first quarter 2025 financial results on Tuesday, May 13, 2025 at 8:00 am ET before the U.S. financial markets open. 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, May 13, 2025 Time: 8:00 a.m. ET Toll free (U.S.): 1-877-790-1503; Conference

      4/30/25 7:30:00 AM ET
      $ACXP
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Acurx Pharmaceuticals to Present at the Alliance Global Partners (A.G.P) Healthcare Company Showcase

      STATEN ISLAND, N.Y., April 28, 2025 /PRNewswire/ -- Acurx Pharmaceuticals (NASDAQ:ACXP) (Acurx or the Company), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections today announced that David P. Luci, President & Chief Executive Officer, will participate virtually in a fireside chat at A.G.P.'s Healthcare Company Showcase on Wednesday, May 21, 2025, at 9:00 a.m. ET. The Company's lead antibiotic candidate, ibezapolstat (IBZ), is ready to advance to international Phase 3 clinical trials for treatment of patients with C. difficile infection (CDI). A live webcast of the presentation can be found here. A replay o

      4/28/25 7:30:00 AM ET
      $ACXP
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $ACXP
    Large Ownership Changes

    This live feed shows all institutional transactions in real time.

    See more
    • SEC Form SC 13G/A filed by Acurx Pharmaceuticals Inc. (Amendment)

      SC 13G/A - Acurx Pharmaceuticals, Inc. (0001736243) (Subject)

      2/14/24 2:39:21 PM ET
      $ACXP
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form SC 13G filed by Acurx Pharmaceuticals Inc.

      SC 13G - Acurx Pharmaceuticals, Inc. (0001736243) (Subject)

      2/14/23 11:59:03 AM ET
      $ACXP
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form SC 13G filed by Acurx Pharmaceuticals Inc.

      SC 13G - Acurx Pharmaceuticals, Inc. (0001736243) (Subject)

      2/14/23 11:52:45 AM ET
      $ACXP
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $ACXP
    Analyst Ratings

    Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

    See more
    • Maxim Group initiated coverage on Acurx Pharmaceuticals with a new price target

      Maxim Group initiated coverage of Acurx Pharmaceuticals with a rating of Buy and set a new price target of $12.00

      11/29/21 8:33:36 AM ET
      $ACXP
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $ACXP
    Insider Purchases

    Insider purchases reveal critical bullish sentiment about the company from key stakeholders. See them live in this feed.

    See more
    • Director Scodari Joseph C bought $25,000 worth of shares (24,631 units at $1.01), increasing direct ownership by 800% to 27,708 units (SEC Form 4)

      4 - Acurx Pharmaceuticals, Inc. (0001736243) (Issuer)

      1/8/25 4:32:30 PM ET
      $ACXP
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Director Sailer Carl bought $25,000 worth of shares (24,631 units at $1.01), increasing direct ownership by 22% to 137,183 units (SEC Form 4)

      4 - Acurx Pharmaceuticals, Inc. (0001736243) (Issuer)

      1/8/25 4:31:59 PM ET
      $ACXP
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • President and CEO Luci David P bought $50,000 worth of shares (49,261 units at $1.01), increasing direct ownership by 5% to 1,097,458 units (SEC Form 4)

      4 - Acurx Pharmaceuticals, Inc. (0001736243) (Issuer)

      1/8/25 4:31:33 PM ET
      $ACXP
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $ACXP
    Insider Trading

    Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

    See more
    • SEC Form 4 filed by Chief Financial Officer Shawah Robert G.

      4 - Acurx Pharmaceuticals, Inc. (0001736243) (Issuer)

      2/6/25 5:47:58 PM ET
      $ACXP
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form 4 filed by President and CEO Luci David P

      4 - Acurx Pharmaceuticals, Inc. (0001736243) (Issuer)

      2/6/25 5:46:58 PM ET
      $ACXP
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form 4 filed by Director Deluccia Robert J

      4 - Acurx Pharmaceuticals, Inc. (0001736243) (Issuer)

      2/6/25 5:45:47 PM ET
      $ACXP
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $ACXP
    SEC Filings

    See more
    • SEC Form S-1 filed by Acurx Pharmaceuticals Inc.

      S-1 - Acurx Pharmaceuticals, Inc. (0001736243) (Filer)

      5/21/25 4:16:04 PM ET
      $ACXP
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form D filed by Acurx Pharmaceuticals Inc.

      D - Acurx Pharmaceuticals, Inc. (0001736243) (Filer)

      5/20/25 3:32:14 PM ET
      $ACXP
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form PRE 14A filed by Acurx Pharmaceuticals Inc.

      PRE 14A - Acurx Pharmaceuticals, Inc. (0001736243) (Filer)

      5/19/25 4:05:41 PM ET
      $ACXP
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $ACXP
    Financials

    Live finance-specific insights

    See more
    • Acurx Pharmaceuticals to Discuss First Quarter 2025 Financial Results on May 13, 2025 Conference Call and Provide Business Update

      STATEN ISLAND, N.Y., April 30, 2025 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP) ("Acurx" or the "Company"), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today that the Company will discuss its first quarter 2025 financial results on Tuesday, May 13, 2025 at 8:00 am ET before the U.S. financial markets open. 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, May 13, 2025 Time: 8:00 a.m. ET Toll free (U.S.): 1-877-790-1503; Conference

      4/30/25 7:30:00 AM ET
      $ACXP
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Acurx Pharmaceuticals to Discuss Fourth Quarter and Full Year 2024 Financial Results on March 18, 2025 Conference Call and Provide Business Update

      STATEN ISLAND, N.Y., Feb. 28, 2025 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP) ("Acurx" or the "Company"), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today that the Company will discuss its fourth quarter and full year 2024 financial results on Tuesday, March 18, 2025 at 8:00 am ET before the U.S. financial markets open. 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 (U.S.): 1-877-79

      2/28/25 8:00:00 AM ET
      $ACXP
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Acurx Pharmaceuticals, Inc. Reports Third Quarter 2024 Results and Provides Business Update

      STATEN ISLAND, N.Y., Nov. 13, 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 third quarter ended September 30, 2024. 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,

      11/13/24 7:00:00 AM ET
      $ACXP
      Biotechnology: Pharmaceutical Preparations
      Health Care