Lisata Therapeutics, Inc.

Welcome to the Lissata Therapeutics Full Year 2024 Financial Results and Business Update Conference Call. Currently, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ask a question at that time, please press star 1-1 on your telephone. You will then hear an automated message advising that your hand is raised. As a reminder, this call is being recorded today, Thursday, February 27, 2025. I will now turn the call over to John Mendito, Vice President of Investor Relations and Corporate Communications at Lissata. Please go ahead, sir.

Thank you, operator, and good afternoon, everyone. Welcome to Lissata's full year 2024 conference call to discuss our financial results and to provide a business update. Joining me today from our management team are Dr. David Mazzo, President and Chief Executive Officer. Dr. Kristen Buck, 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 full year 2024 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'd like to be added to the company's email distribution list, please subscribe to the email alerts on the company website or email me at jmendito at lasada.com. Before we begin, I'll 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, February 27th, 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. With that, I'll now turn the call over to Dr. Mazzo. Dave? Thank you, John, and good afternoon, everyone. It's a pleasure to be here again to provide an overview of Lasada's recent business highlights, discuss our full year 2024 financial results, and give an update on the progress of our development programs. Over the course of 2024 and now into early 2025, we have advanced our development portfolio centered around our novel product candidate, Sotepetide, for the treatment of advanced solid tumors and other difficult-to-treat diseases. The ongoing accumulation of both preclinical data and early clinical data supports our belief that tritepatide has the potential to become an integral part of a revised standard-of-care treatment regimen for advanced solid tumors, including pancreatic cancer, cholangiocarcinoma, glioblastoma, colon cancer, appendiceal cancer, and melanoma. We were particularly encouraged by the preliminary results from Cohort A of the ASCEND trial and the I-LISTED trials presented at the 2025 ASCO GI Symposium in January. These data, while early, provide further validation of certepatite's potential and reinforce our conviction that certepatite could become a critical component of future treatment regimens for these devastating cancers. We are working diligently to advance these studies and explore additional anti-cancer combinations and treatment strategies. Beyond oncology, we are also excited about the potential of Sertepetide in other therapeutic areas. We have initiated the preclinical investigation of Sertepetide as a potential therapeutic agent for the treatment of endometriosis, a disease which affects hundreds of millions of women worldwide and for which there remains a pronounced unmet medical need. Looking ahead, we anticipate 2025 will be a data-rich year for Lasada. We have several key milestones on the horizon, and will share our progress and key findings as they become available. Following the review of our financial results, Dr. Kristen Buck, our Chief Medical Officer and Head of Research and Development, will provide a detailed update on our ongoing and planned clinical and preclinical programs, including timelines and key objectives. 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 full year 2024 financial results, starting with operating expenses. For the year ended December 31st, 2024, revenue totaled $1 million in connection with an upfront license fee related to the exclusive license and collaboration agreement with Kuva Labs, Inc. the company did not have any revenue for the year ended December 31st, 2023. For the year ended December 31st, 2024, operating expenses totaled $23.4 million compared to $25.7 million for the year ended December 31st, 2023, representing a decrease of $2.3 million or 8.9 percent. Research and development expenses were approximately $11.3 million for the year ended December 31st, 2024, compared to $12.7 million for the year ended December 31st, 2023, representing a decrease of approximately $1.4 million, or 11%. This was primarily due to a reduction in expenses associated with the Phase IIb ASCEND trial which completed enrollment in the prior year, lower spend on chemistry manufacturing and controls, and lower equity expense. General and administrative expenses were approximately $12.1 million for the year ended December 31st, 2024, compared to $13 million for the year ended December 31st, 2023. representing a decrease of approximately 0.9 million or 6.9 percent. This was primarily due to one-off related severance costs in the prior year associated with the elimination of the chief business officer position on May 1st, 2023. A reduction in equity expense, a decrease in directors and officers insurance premiums, and a reduction in spend on legal fees partially offset by one-off settlement-related costs and an increase in consulting expenses. Overall, net losses were $20 million and $20.8 million for the years ended December 31st, 2024, and 2023, respectively. 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 December 31st, 2024, we had cash, cash equivalents, and marketable securities of approximately $31.2 million. Based on Lasada's existing and planned activities, the company believes available funds will support current operations into the second quarter of 2026. Lastly, an update regarding the net operating loss sale. Earlier this year, we received $0.9 million in non-dilutive funding as an approved participant of the Technology Business Tax Certificate Transfer Program sponsored by the New Jersey Economic Development Authority. The program enables qualifying New Jersey-based biotechnology or technology companies to sell a percentage of their New Jersey net operating losses and research and development tax credits to unrelated qualifying corporations with a lifetime cap on the tax benefit sales of $20 million. To date, under the program, we have sold $19.6 million in tax benefits for net proceeds of $18.4 million. With that, I will now turn the call over to Dr. Kristen Buck to provide an overview of the company's development programs. Kristen?