Lisata Therapeutics(US:LSTA)2021-05-07 07:18Financial Data and Key Metrics Changes - Research and development expenses for Q1 2021 were $5.1 million, up from $1.5 million in Q1 2020, reflecting a focus on advancing the ischemic repair platform and related clinical trials [11] - General and administrative expenses increased to $3 million in Q1 2021 from $2.6 million in Q1 2020, representing an 18% increase due to stock awards and rising insurance premiums [12] - Net losses for Q1 2021 were $8.1 million compared to $4 million in Q1 2020 [12] - As of March 31, 2021, the company had cash, cash equivalents, and marketable securities of approximately $111.5 million, expected to fund operations for several years [16] Business Line Data and Key Metrics Changes - The company is advancing multiple clinical programs, including CLBS16 for coronary microvascular dysfunction, HONEDRA for critical limb ischemia and Buerger's disease, and CLBS201 for diabetic kidney disease [8][19] - The FREEDOM trial for CLBS16 is currently recruiting patients, with top-line data anticipated in Q3 2022 [29] - The HONEDRA study in Japan has shown positive results, particularly in the Buerger's disease cohort, with four out of seven subjects meeting the primary endpoint [39][40] Market Data and Key Metrics Changes - The company has successfully raised $90 million in new capital in 2021, providing financial security amidst a challenging market for small biopharma companies [15] - The ongoing COVID-19 pandemic has impacted patient enrollment in the HONEDRA trial in Japan, while the FREEDOM trial has experienced minimal impact [54][56] Company Strategy and Development Direction - The company focuses on developing autologous cellular therapies aimed at reversing diseases, with a commitment to personalized curative cell therapy products [19][20] - The strategy includes exploring additional pipeline expansion opportunities, particularly in areas related to ischemic conditions and renal diseases [72] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial position and ability to fund operations for the next several years based on current development plans [8][16] - The company remains optimistic about the progress of its clinical trials and the potential for successful outcomes despite the challenges posed by the pandemic [50] Other Important Information - The FDA granted orphan designation to CLBS12 for the treatment of Buerger's disease in the U.S., enhancing its development prospects [40] - The company is actively seeking partnerships for the commercialization of HONEDRA in Japan [42] Q&A Session Summary Question: Impact of COVID-19 on the FREEDOM trial - Management indicated minimal impact on the FREEDOM trial due to COVID-19, with site openings on track and patient recruitment not significantly affected [54] Question: Patient recruitment considerations for the FREEDOM trial - Management confirmed that they are accounting for gender and age in patient enrollment, targeting a population primarily consisting of younger females [60] Question: Financial burn rate and future spending - Management clarified that while the current burn rate is around $8 million per quarter, future spending will depend on the outcomes of ongoing trials and potential new studies [66][69] Question: Pipeline expansion opportunities - Management stated that pipeline expansion explorations are opportunistic, focusing on affordable projects with a high probability of clinical success [72] Question: Discussions with the FDA regarding NORDA - Management expressed frustration with the FDA's requirements for a large clinical trial for NORDA, emphasizing the need for a more practical study design to facilitate patient enrollment [79]