Financial Data and Key Metrics Changes - For Q3 2023, operating expenses totaled $6 million, a decrease of 84.2% compared to $37.7 million in Q3 2022. Excluding a $30.4 million in-process research and development expense from a merger, operating expenses decreased by $1.4 million or 18.6% year-over-year [5][82]. - General and administrative expenses were approximately $2.6 million for Q3 2023, down 35.3% from $4.0 million in Q3 2022, primarily due to nonrecurring merger-related costs in the prior year [81]. - Net losses were $5.3 million for Q3 2023, compared to $37.4 million in Q3 2022. Excluding the merger-related expense, net losses decreased by $1.7 million or 24.7% year-over-year [82]. Business Line Data and Key Metrics Changes - Research and development expenses were approximately $3.4 million for Q3 2023, slightly up from $3.3 million in Q3 2022, primarily due to study activities associated with ongoing clinical trials [71]. - The ASCEND trial has achieved full enrollment in Cohort A and is approximately 95% complete overall, with top-line data expected in late 2024, a year earlier than initially anticipated [85][61]. Market Data and Key Metrics Changes - The company had cash, cash equivalents, and marketable securities of approximately $54.4 million as of September 30, 2023, which is projected to fund operations into early 2026 [6]. - The company is experiencing a low trading volume, averaging 20,000 to 25,000 shares per day out of over 8 million outstanding, which contributes to stock price volatility [60]. Company Strategy and Development Direction - The company aims to enhance the efficacy of various anticancer therapies through its lead product candidate, LSTA1, which targets advanced solid tumors [70][84]. - The strategy includes conducting multiple clinical trials globally, focusing on the combination of LSTA1 with standard therapies for various solid tumors, including pancreatic and glioblastoma cancers [21][54]. Management's Comments on Operating Environment and Future Outlook - Management noted that the biotech market has faced challenges due to high interest rates, impacting stock prices across the sector, despite the company's strong fundamentals and execution [46]. - The company believes that the current market cap is irrational, trading at approximately 35% to 40% of its cash on hand, and expects this to change as pivotal data from trials is released [46][48]. Other Important Information - LSTA1 has received multiple orphan drug designations, including for pancreatic cancer and malignant glioma, which may facilitate faster market access [54][64]. - The company is eligible for a refundable tax incentive in Australia for qualifying R&D activities, which significantly offsets trial expenses [92]. Q&A Session Summary Question: What are the implications of the orphan drug and fast-track designations? - These designations allow for accelerated approval consideration and more rapid review cycles with the FDA, which are beneficial for getting products to market faster [42][64]. Question: How does the company view its market cap and stock price? - Management expressed concern over the inconsistency between the company's advanced clinical programs and its low market cap, attributing it to broader market conditions and shareholder behavior [46][48]. Question: What factors are contributing to rapid trial enrollment? - The trial's design allows control arm participants to receive standard care, making participation more appealing, alongside the treatment-naive population in Australia [15][90].
Lisata Therapeutics(LSTA) - 2023 Q3 - Earnings Call Transcript