8/12/2025

speaker
Stacey
Operator

Greetings and welcome to the Accurate Pharmaceuticals to discuss second quarter 2025 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Robert Shaw, Chief Financial Officer. Please go ahead.

speaker
Rob Schaller
Chief Financial Officer

Thank you, Stacey. Good morning and welcome to our call. This morning we issued a press release providing financial results and company highlights for the second quarter of 2025, which is available on our website at acorexpharma.com. Joining me today is Dave Lucci, President and CEO of Acorex, who will give a corporate update and outlook. Following that, I'll provide some highlights of the financials from the second quarter ended June 30th And then turn the call back over to Dave for his closing remarks. As a reminder, during today's call, we'll be making certain forward-looking statements, which are based on current information, assumptions, estimates, and projections about future events that are all subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. Investors should consider these risks and other information described in our filings with the Securities and Exchange Commission, including our quarterly report on Form 10-Q, which we filed yesterday, Monday, August 11, 2025. You are cautioned not to place undue reliance on these forward-looking statements and after X disclaims any obligation to update such statements at any time in the future. This conference call contains time-sensitive information. That's accurate only as of the date of this live broadcast today, August 12th, 2025. I'll now turn the call over to Dave. Dave?

speaker
Dave Lucci
President and Chief Executive Officer

Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for the second quarter of 25 and also to hear some recent updates. Then we'd be pleased to take any questions. First, I'd like to briefly summarize just a few of our key activities for the second quarter or, in some cases, shortly thereafter. In April, we announced that the Indian Patent Office granted a new patent for our DNA polymerase 3C inhibitors, which expires in December 2039, subject to extension. This constitutes another significant building block for our ongoing preclinical antibiotic development program of ACX375C, which targets the treatment of infections caused by MRSA, VRE, DRSP, and anthrax. In May, we closed an equity line of credit with Lincoln Park Capital for up to $12 million of additional funding. In June, the company entered into a warrant inducement agreement with an existing warrant holder for the exercise of warrants to purchase an aggregate of 222,272 shares of the company's common stock, having a current exercise price for the Series A warrants to purchase 538 shares of the company's common stock at $65 per share. For Series B warrants to purchase 27,400 shares of our common stock at $65 per share. And for Series C warrants to purchase 66,667 shares of our common stock at $65.20 per share. And Series D warrants to purchase 66,667 shares of our common stock at an exercise price of $65.20 per share. Original was issued in July 22 and May 23 at a reduced exercise price of $12 per share. In consideration for the company's agreement to issue new Series G1 warrants to purchase up to an aggregate of 311,180 shares of common stock with a five-year term and new Series G warrants to purchase up to an aggregate 133,363 shares of a common stock with a five-year term from shareholder approval, each at an exercise price of $8.50 per share. The gross proceeds to the company from the exercise of the existing warrants was approximately 2.7 million, with net proceeds of 2.5 million after deducting fees and expenses payable by the company. The warrant-inducing transaction closed on June 20th. The company will continue its multi-step approach to raising capital through customary financings, warranted inducements, and public-private partnership opportunities going forward. In June, we announced the publication of our Phase 2B clinical trial data for a desert pulse bat and C. vivacele infection in Lancet Micro, the world-leading microbiology research journal. This publication is available on our website at accuracypharma.com. The Lancet micro summary highlighted Ivesipulstat's phase two results as follows, and I quote, results included high rates of clinical cure in Ivesipulstat-treated subjects with no recurrence. Furthermore, Ivesipulstat was found to be safe, well-tolerated, and associated with the preservation of key health-promoting bacteria responsible for bile acid homeostasis, a key component in preventing recurrent CDI, end quote. The Lancet publication also highlighted Ibexipustep's potential as a novel antibiotic treatment for CDI with high rates of clinical cures and sustained clinical cure, while preserving and restoring the healthy gut microbiota. The senior author, Professor Tanigiri, PhD, University of Houston, and a co-author of the IDSA infectious disease society of America treatment guidelines for C. difficile infection, noted that current U.S. and European treatment guidelines for CDI recommend only two antibiotics for treatment, oral vancomycin or fadaxomycin. Vancomycin is most commonly used but has a low clinical cure rate of 70% to 92% and a sustained clinical cure rate of 42% to 71%. Fadaxomycin has fewer recurrences but low rates of clinical cure at about 84%, and sustained clinical cure at 67%. Professor Gary further noted that both marketed antibiotics for CDI are associated with emerging antimicrobial resistance, stating, and I quote, the clinical need for a new antibiotic, like Ibenzopulstat, to treat CDI is underscored by a recently published study in clinical infectious diseases by Dr. Curtis Donsky of the Cleveland VA and conducted in a hospital setting documented that C. difficile isolates with clinically relevant reduced Fidaximinosine susceptibility may emerge during therapy and spread to other patients. The medical community should be aware of this alarming finding, end quote. Again, that's by Dr. Gary. Also in June, we announced results from our collaboration with Leiden University Medical Center of its study of the mechanism of action of our polymerase 3C platform of inhibitors, with data presented at the Federation of American Societies for Experimental Biology Scientific Topics, to meet in the Netherlands on May 21st. A scientific presentation was provided by Mia Oren, PhD, from Leiden University Medical Center, entitled, A Unique Inhibitor Confirmation Selectively Targets the DNA Polymerase Policy of Gram-Positive Priority Pathogens. This scientific conference is the premier venue for the newest research and technological trends in molecular machines in the human body that ensure DNA replication and expression of genes to create proteins that make up the cell. In August, we implemented a 1 for 20 reverse stock split in an effort to comply with the NASDAQ listing maintenance requirements. We continue to identify and pursue funding opportunities for our Phase III clinical trial program for Ibenzopulstat and consider alternative financial pathways to achieve success. We have several initiatives underway to this end and will report in future updates as appropriate. As we've continually reported, Ibenzopulstat clinical results continue to demonstrate its leadership in the field in a serious and potentially life-threatening infectious disease called C. difficile bacteria. that the U.S. CDC categorizes as an urgent threat and calls for new classes of antibiotics for initial treatment that also have low incidence of recurrence. Ibenzapolstap has FDA QIDP and fast-track designations for the treatment of CDI. We also believe that Ibenzapolstap, if approved, could make a favorable economic impact by reducing the overall annual U.S. cost burden for C. diff infection of approximately $5 billion a year, of which 2.8 billion is due to recurrent infection, what we call the secondary market. With our continuing momentum and passion to achieve success for our stakeholders, we remain confident that while development of IPEZA's competitive profile continues to strengthen, the best is yet to come as we navigate through these very challenging times in the macroeconomic environment and in our industry sector. And now back to our CFO, Rob Schaller, to guide you through the highlights of our financial results for the second quarter of 25. Rob?

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-