Yahoo Finance Acurx Pharmaceuticals Inc (ACXP) Q1 2024 Earnings Call Transcript Highlights: Key Financial and ...
Cash Position: $8.9 million as of March 31, 2024, up from $7.5 million as of December 31, 2023.
Net Loss: $4.4 million or $0.28 per diluted share for Q1 2024, compared to a net loss of $2.9 million or $0.25 per diluted share for Q1 2023.
Research and Development Expenses: $1.6 million for Q1 2024, up from $1 million for Q1 2023.
General and Administrative Expenses: $2.8 million for Q1 2024, up from $1.9 million for Q1 2023.
Shares Outstanding: 15,757,102 as of March 31, 2024.
ATM Financing: Sold an additional 1,121,793 shares with gross proceeds of approximately $4.4 million during Q1 2024.
Release Date: May 15, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
Ibezapolstat showed superior efficacy in eradicating C. difficile compared to vancomycin in Phase IIb trials, with a 94% success rate versus 71% for vancomycin.
Ibezapolstat has demonstrated the ability to preserve and allow regrowth of key gut bacteria, potentially reducing the recurrence of C. diff infections.
Acurx Pharmaceuticals Inc (NASDAQ:ACXP) has successfully reached agreement with the FDA on key elements of the Phase III program, indicating readiness to proceed to the next phase of clinical trials.
The company has secured SME status in Europe, providing benefits such as fee reductions and support from the European Medicines Agency.
Acurx Pharmaceuticals Inc (NASDAQ:ACXP) has a robust financial position with an increase in cash from $7.5 million to $8.9 million and successful additional share sales generating $4.4 million.
Negative Points
The company reported an increased net loss of $4.4 million for Q1 2024, up from $2.9 million in the same period the previous year.
Research and development expenses increased significantly, from $1 million to $1.6 million, due to higher manufacturing-related costs.
General and administrative expenses also rose from $1.9 million to $2.8 million, driven by increases in professional fees and noncash share-based compensation.
Acurx Pharmaceuticals Inc (NASDAQ:ACXP) is still in the process of finalizing costs and timelines for Phase III trials, indicating potential uncertainties in future expenditures.
The company has not yet secured any commitments from potential partners for further development and commercialization of ibezapolstat, despite active discussions.
Q & A Highlights
Q: Bob, can you confirm the total number of subjects for the upcoming trial and clarify if the Phase Ib is considered one of the two pivotal studies required by the FDA? A: David P. Luci - Co-Founder, President, CEO, Corporate Secretary & Director, Acurx Pharmaceuticals, Inc. - The total number of subjects for each of the two Phase III registration trials is 450, making it 900 in total. The Phase IIb is not considered a registration trial due to its small size. The upcoming trials are necessary to build a satisfactory safety database for an NDA application.
Q: Could you provide any preliminary information on the costs and timelines for the upcoming trials? Also, are there any active discussions regarding strategic partnerships? A: David P. Luci - Co-Founder, President, CEO, Corporate Secretary & Director, Acurx Pharmaceuticals, Inc. - We are currently finalizing the costs and timelines. Discussions about partnerships are active, especially now that we have a clear pathway for a pivotal study. We are engaging in several discussions, but nothing is finalized yet.
Q: When do you anticipate starting the first of the two Phase III trials? A: David P. Luci - Co-Founder, President, CEO, Corporate Secretary & Director, Acurx Pharmaceuticals, Inc. - We aim to start enrollment in the fourth quarter of this year, contingent on adequate funding. The enrollment is expected to take 18 to 24 months.
Q: Has the company considered applying for a priority review voucher for this application? A: Robert J. DeLuccia - Co-Founder & Executive Chairman, Acurx Pharmaceuticals, Inc. - We already have priority review due to our FDA fast track status. However, we are open to exploring the possibility of a priority review voucher, which could be a significant source of funding.
Q: Can you discuss the partnership environment as you approach Phase III? A: David P. Luci - Co-Founder, President, CEO, Corporate Secretary & Director, Acurx Pharmaceuticals, Inc. - The environment is quite robust. We have a lot of interest from potential partners, and we are being judicious in our discussions to ensure we make the right deal without overly diluting our company.
Q: Is there an opportunity for any interim looks during the Phase III trials, and could you update us on the PASTEUR Act? A: David P. Luci - Co-Founder, President, CEO, Corporate Secretary & Director, Acurx Pharmaceuticals, Inc. - We do not plan to conduct interim looks as they require adding patients and do not provide significant insights. Regarding the PASTEUR Act, it is unlikely to pass this year, but we are monitoring potential funding opportunities for new classes of antibiotics through other government programs.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.
