Acurx's Q3 2025 Earnings Call: Contradictions in Partnership Timelines, Operating Expenses, and Phase III Trial Plans

Date of Call: November 12, 2025

Financials Results

• EPS: $-1.23 per diluted share for Q3 2025, compared to a net loss of $-3.45 per diluted share for Q3 2024; 9M 2025 net loss $-5.01 per diluted share versus $-14.23 for 9M 2024

Business Commentary:

* Reverse Stock Split and Listing Compliance: - Acurx Pharmaceuticals effected a 1-for-20 reverse stock split, which led to the company regaining compliance with the minimum bid price requirements under Nasdaq listing rules. - The reverse split raised the stock price to meet the minimum bid price requirement of $1 per share and increased the stockholder equity threshold to $2.5 million.

• Funding and Financial Stability:
• The company raised approximately $1.7 million in gross proceeds through an equity line of credit and $1.4 million from a warrant exercise, ending the quarter with $5.9 million in cash.

• The funds will support ongoing operations and contribute to financial stability while the company explores public-private partnerships and M&A activities.

• Patent and Intellectual Property Expansions:

• Acurx obtained a new patent in Australia and additional patents in other countries for its DNA polymerase IIIC inhibitors, expanding its IP portfolio.
• These patents cover the ACX-375C program, protecting the company's innovative approach to treating infections caused by Gram-positive bacteria, including MRSA, VRE, and PRSP.

• Scientific Collaborations and Milestones:
• A collaboration with Leiden University Medical Center resulted in the publication of research demonstrating a DNA pol IIIC inhibitor bound to its target, providing a unique inhibitor confirmation.

• This milestone advances the development of new-to-nature compounds and strengthens the foundation for the rational development of innovative antimicrobials against other Gram-positive pathogens.

• Cost Management and Financial Performance:

• Research and development expenses for the quarter were $0.4 million, a decrease of $0.8 million from the previous year, primarily due to reduced manufacturing and consulting costs.
• The company reported a net loss of $2 million or $1.23 per diluted share for the quarter, compared to a net loss of $2.8 million or $3.45 per diluted share in the previous year.
  

  Sentiment Analysis:

  Overall Tone: Positive

  • Management highlighted regained Nasdaq compliance, new patents (including Australia), a Nature Communications publication showing target binding, microbiome-sparing data supporting a class effect, cost reductions and cash of $5.9M (plus $1.4M post-quarter) and an available $9M ELOC, and stated expectations for potential partnership news by the next earnings call.

Q&A:

• Question from Jason McCarthy (Maxim Group): Given recent FDA changes, do you see increased potential for the agency to prioritize domestically manufactured novel antibiotics and can you share perspective on the PASTOR Act and its potential impact?
  Response: We are Fast-Track/QIDP and evaluating legislative/public-private funding opportunities, but do not expect near-term impact from the PASTOR Act due to current Washington funding priorities and delays.

• Question from Jason McCarthy (Maxim Group): Does the proposed clinical priority review voucher framework change your regulatory approach or commercial strategy?
  Response: No material change; we'll pursue such programs opportunistically but continue to prioritize Phase III and a 20‑patient secondary C. diff trial.

• Question from Jason McCarthy (Maxim Group): Have you explored filing for approval based solely on Phase IIb data and what would that regulatory pathway look like?
  Response: Phase IIb is insufficient—FDA will require a larger safety database, so Phase III data will be needed for approval.

• Question from Matthew Keller (H.C. Wainwright & Co): How are recent publications and presentations informing or changing your clinical strategy ahead of potential Phase III?
  Response: The microbiome‑sparing data doesn't change the Phase III plan but increases confidence in a class effect and supports a 20‑patient secondary/salvage trial to demonstrate lasting cures.

• Question from James Molloy (Alliance Global Partners): Can you put timing or a framework around potential partnership discussions or when Phase III could start?
  Response: Partnership timing is uncertain and two‑sided, but management expects the possibility of major news by the next earnings call.

• Question from James Molloy (Alliance Global Partners): Are QIDP and Fast-Track designations maintained indefinitely once granted?
  Response: Yes; those designations remain once granted.

• Question from James Molloy (Alliance Global Partners): Are the current OpEx levels the run-rate we should expect going forward absent major events?
  Response: OpEx should remain steady or gradually decline; cash was ~$5.9M at quarter end plus $1.4M post‑quarter (≈$7M) and about $9M available on the ELOC, providing runway while pursuing partnerships/M&A.

Contradiction Point 1

Partnership Timeline and Strategy

It involves differing expectations and timelines regarding the potential signing of a partnership, which is crucial for the advancement of the company's clinical trials and overall strategy.

Can you provide a framework or timeline for potential partnership discussions? - James Molloy (Alliance Global Partners)

2025Q3: A partnership is a 2-way street. We may have major news on the next earnings call, but the timing is uncertain due to the nature of partnerships. - David Luci(CEO)

When is the potential partnership expected to be signed in 2025 or 2026 to initiate the ibezapolstat trials? - James Molloy (Alliance Global Partners)

2025Q2: While partnerships could be announced in the second half of 2025, they may also slip into 2026 due to federal government funding processes. - David Luci(CEO)

Contradiction Point 2

Operating Expenses and Financial Strategy

It involves differing statements regarding the company's financial strategy and the expected trajectory of operating expenses, which are critical for investor expectations and financial planning.

Should we expect these OpEx numbers to continue going forward, assuming no major announcements before the next call? - James Molloy (Alliance Global Partners)

2025Q3: We're tightening our belt. Costs may gradually decrease, and we have a solid cash position to navigate through partnerships or M&A. - David Luci(CEO)

Will the decline in operating expenses continue through 2025 and 2026? - James Molloy (Alliance Global Partners)

2025Q2: Yes, Acurx is expecting to continue reducing operational expenses, with cash burn now at around $400,000 per month. - David Luci(CEO)

Contradiction Point 3

Cost Structure and Control

It involves discrepancies in the reported cost structure and control measures, which are integral to the company's financial health and sustainability.

Should we expect these OpEx numbers to continue, assuming no major changes are announced before the next call? - James Molloy (Alliance Global Partners)

2025Q3: We're tightening our belt. Costs may gradually decrease, and we have a solid cash position to navigate through partnerships or M&A. - David Luci(CEO)

Will current G&A and R&D levels remain for the rest of the year? How will G&A and R&D change once the Phase 3 program begins? Is there an update on the expected start date of Phase 3? - James Molloy (Alliance Global Partners)

2025Q1: We've done some cost-cutting that will continue until we start the Phase 3 program. R&A and G&A costs are expected to decline until then. - David Luci(CEO)

Contradiction Point 4

Phase III Trial Timing and Partnerships

It involves the timeline and strategic approach related to the initiation of Phase III trials and the pursuit of partnerships, which are crucial for the company's clinical development and financial stability.

Can you establish a framework or timeline for potential partnerships? - James Molloy (Alliance Global Partners)

2025Q3: We may have major news on the next earnings call, but the timing is uncertain due to the nature of partnerships. - David Luci(CEO)

Are market conditions affecting partnership opportunities? When do you plan to initiate Phase 3 trials? - James Molloy (Alliance Global Partners)

2024Q4: We aim to start the Phase 3 trials this year, though there may be a few months' delay post-funding. - David Luci(CEO)

Contradiction Point 5

Financial Stability and Operational Expenditures

It revolves around the company's financial stability and operational cost management, which are vital for sustaining its research and development efforts during a challenging market environment.

Will these OpEx numbers remain consistent going forward, assuming no major announcements before the next call? - James Molloy (Alliance Global Partners)

2025Q3: We're tightening our belt. Costs may gradually decrease, and we have a solid cash position to navigate through partnerships or M&A. - David Luci(CEO)

If the trial starts, what is the current expectation for top-line data or an interim analysis? - James Molloy (Alliance Global Partners)

2024Q4: We expect OpEx to be roughly $14 million to $15 million for 2025. OpEx for 2024 was $13.6 million. We expect to continue to grow the team in 2025. - David Luci(CEO)