Lisata Therapeutics(US:LSTA)2021-11-04 23:44Financial Data and Key Metrics Changes - Research and development expenses for Q3 2021 were approximately $4.1 million, an increase from $3 million in Q3 2020, reflecting ongoing efforts in clinical programs [12] - General and administrative expenses rose to approximately $2.8 million in Q3 2021 from $2.3 million in Q3 2020, a 22% increase primarily due to higher D&O insurance premiums and strategic consulting expenses [14] - Overall net losses for Q3 2021 were $6.9 million, compared to $5.3 million in Q3 2020 [14] - As of September 30, 2021, the company had cash, cash equivalents, and marketable securities of approximately $100.1 million, sufficient to fund operations for the next several years [18] Business Line Data and Key Metrics Changes - The company is advancing its CD34+ cell technology-based clinical programs, focusing on ischemic repair and related treatments [9] - The HONEDRA product candidate for CLI and Buerger's disease in Japan has shown positive results, but enrollment has been challenging due to COVID-19 restrictions [27][28] - The XOWNA product for coronary microvascular disease is currently in a Phase 2b clinical trial, with efforts to expand enrollment through protocol amendments [35][36] Market Data and Key Metrics Changes - The company has successfully secured $90 million in new capital gross proceeds year-to-date in 2021, providing financial security amid the pandemic [17] - The HONEDRA program in Japan has been impacted by multiple states of emergency, affecting patient enrollment and operational costs [27][66] Company Strategy and Development Direction - The company aims to identify and secure additional development assets to complement its current portfolio, focusing on maximizing clinical and commercial success while minimizing capital outlay [40] - The strategic focus includes advancing autologous cellular therapies designed to treat and reverse diseases, particularly those caused by ischemia [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial position and operational strategy despite the challenges posed by the COVID-19 pandemic [9][42] - The company is optimistic about the potential for regenerative therapies to improve patient outcomes, particularly in the context of diabetic kidney disease [49] Other Important Information - The company has received SAKIGAKE Designation for HONEDRA in Japan, which allows for prioritized regulatory consultation and potentially expedited approval processes [24] - The FDA granted Orphan Designation to CLBS12 for Buerger's disease, but further clinical programs in the U.S. are currently not being pursued due to regulatory feedback [31][32] Q&A Session Summary Question: Impact of HONEDRA on near-term expenses - Management expects to save several million dollars in 2022 due to the decision to suspend enrollment efforts in Japan, which has incurred significant expenses without patient enrollment [45] Question: Deterioration of diabetic kidney disease patients if untreated - Management indicated that identifying the rate of deterioration is challenging, but the goal is to demonstrate regeneration of kidney function rather than merely slowing disease progression [46][49] Question: Enrollment issues across different programs - Management noted that enrollment challenges are due to a combination of staff shortages, patient reluctance to seek treatment, and COVID-related restrictions across all geographies [62][64] Question: Regulatory discussions for HONEDRA - Management highlighted the difficulty in having discussions with Japanese regulatory authorities due to travel restrictions, emphasizing the need for a local partner to facilitate these discussions [69] Question: Funding opportunities for strategic partnerships - Management discussed the challenges in obtaining non-dilutive funding and the competitive nature of grant applications, noting that public companies often face difficulties in securing such funding [78][81]