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8/7/2025
Welcome to the Lysetta Therapeutics Second Quarter 2025 Financial Results and Business Update Conference Call. Currently, all participants are in the listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ask a question at the time, please press star 11 on your telephone. You will then hear an automated message advising a hand is raised. As a reminder, this call is being recorded today, Thursday, August 7, 2025. I will now turn the call over to John Mendito, Vice President of Investor Relations and Corporate Communications at Lesada. Please go ahead, sir.
Thank you, Operator, and good afternoon, everyone. For those of you who have been on Lesada's calls previously, you'll recognize that this is not John Mendito speaking, but this is actually the President and Chief Executive Officer, David Mazzo. Unfortunately, John is having technical difficulties and hasn't been able to join the call, and some of the other speakers have also been having some issues today, so we apologize for any inconsistent sound, and we hope that you'll be able to hear the webcast at a later date. Joining me from the management team are Dr. Kristen Buck, the Executive Vice President of Research and Development and Chief Medical Officer, and James Nisko, Senior Vice President of Finance and Treasury and Chief Accounting Officer. Shortly before this call, we issued a press release announcing our second quarter 2025 financial results, which is available under the Investors and News section of the company website, along with a webcast replay of this call. If you have not received this news release or if you would like to be added to the company's email distribution list, please subscribe to email alerts on the company website or email John Mendito at jmendito, M-E-N-D-I-T-O, at lasada.com to be added. Before we begin, I will remind you that comments made by management during this conference call will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of LASADA. I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, its forms 10-Q, 8-K, and 10-K, which identify specific risk factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, Thursday, August 7, 2025. La Sada Therapeutics undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. I will now continue with my prepared remarks, and it, of course, is a pleasure to provide you with the latest update of La Sada's recent business highlights, discuss our second quarter 2025 financial results, and give a report on the progress of our development programs. Year-to-date, La Sada has executed on and achieved a number of impactful clinical and corporate milestones, with many of those coming since the start of the second quarter. On the business front, we signed a research agreement with Catalan exploring synergy between Certepatide and their advanced antibody drug conjugate platform, and we formed a strategic alliance with GATC Health, employing their MAT artificial intelligence platform as a potential source of new drug development candidates, either alone or in combination with Certepatide. Importantly, we recently announced preliminary results from both the ASCEND and I-LISTED trials that were particularly encouraging, clearly validating Certepatide's promise and our overall development approach. We continue to anticipate that the next 12 months will be a data-rich period for LASADA with several key milestones on the horizon. And following the review of our financial results, Dr. Kristen Buck, our Chief Medical Officer and Head of R&D, will provide an update on our ongoing and planned clinical studies, including timelines and key objectives. And with that, I will now turn the call over to James Nisko, our Senior Vice President of Finance and Treasury and Chief Accounting Officer. James?
Thanks, Dave. Good afternoon, all. I'm pleased to join you today to present a summary of our second quarter 2025 financial results. starting with revenue. For the three months ended June 30, 2025, revenue totaled $70,000 in connection with an upfront license fee related to a research license agreement with Catalan Inc. We did not have any revenue for the three months ended June 30, 2024. Next, a review of our operating expenses. For the three months ended June 30, 2025, Operating expenses totaled $4.9 million compared to $5.5 million for the three months ended June 30, 2024, representing a decrease of $0.6 million or 10.6%. Research and development expenses were approximately $2.3 million for the three months ended June 30, 2025, compared to $2.6 million for the three months ended June 30, 2024, representing a decrease of $0.3 million, or 13.4%. This was primarily due to a reduction in patient treatment costs and clinical research organization expenses associated with our Phase IIa bolster trial and lower spend on chemistry, manufacturing, and controls. General and administrative expenses were approximately $2.7 million for the three months ended June 30, 2025, compared to $2.9 million for the three months ended June 30, 2024, representing a decrease of $0.2 million, or 8.1%. This was primarily due to savings resulting from the elimination of an employee position and lower spend on consulting and travel and entertainment expenses. Overall, net losses were 4.7 million for the three months ended June 30th, 2025, compared to 5 million for the three months ended June 30th, 2024. It is noteworthy that we continue to make progress according to our plans for our R&D and business activities while continuing our legacy of prudent capital management and expense minimization. Turning now to our balance sheet and cash flow. As of June 30, 2025, we had cash, cash equivalents, and marketable securities of approximately $22 million. Based on its existing and planned activities, the company believes available funds will support current operations into the fourth quarter of 2026. With that, I will now turn the call over to Dr. Kristen Buck to provide an overview of the company's development programs. Kristen?
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