Lisata Therapeutics(US:LSTA)2022-03-23 00:52Financial Data and Key Metrics Changes - Research and development expenses for Q4 2021 were $4.2 million, a 43% increase compared to $2.9 million in Q4 2020, and $17.7 million for the full year 2021, up approximately 91% from $9.3 million in 2020 [8][10] - General and administrative expenses for Q4 2021 were $2.7 million, a 6% increase from $2.5 million in Q4 2020, and $11.4 million for the full year 2021, a 15% increase from $9.9 million in 2020 [10] - Net losses were $27.5 million for the year ended December 31, 2021, compared to $8.1 million for 2020 [10] Business Line Data and Key Metrics Changes - The company focused on advancing its ischemic repair platform, including the FREEDOM trial, XOWNA, CLBS16, and the Phase 1 trial for CLBS201 [9][34] - HONEDRA in Japan received SAKIGAKE Designation, which allows for prioritized consultation and a reduced review time for registration applications [21][22] Market Data and Key Metrics Changes - The company successfully raised $90 million in new capital growth proceeds in 2021, providing financial security to focus on its business plan [13] - As of December 31, 2021, the company had cash, cash equivalents, and marketable securities of approximately $95 million, projected to fund operations for several years [14] Company Strategy and Development Direction - The company aims to identify and evaluate strategic development opportunities to enhance shareholder value beyond its current pipeline [7] - There is a focus on securing additional development assets to diversify the product candidate portfolio [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating challenges posed by the COVID-19 pandemic and financial markets while advancing development programs [7] - The company is optimistic about its prospects and sees a bright future ahead, driven by the advancement of its existing portfolio and potential new assets [37] Other Important Information - The company has suspended enrollment efforts for HONEDRA to minimize operational and financial burdens due to delays caused by the pandemic [25] - The FREEDOM trial for XOWNA is experiencing enrollment challenges due to COVID-19 and changes in diagnostic technology [32][59] Q&A Session Summary Question: Strategic development options and stage of development - Management prefers assets that are already in the clinic, ideally with Phase 1 data, and is looking at numerous assets due to market volatility [42][44] Question: Alternative avenues for HONEDRA - Management is exploring various strategies, including using existing data for potential partnerships, rather than incurring additional costs for enrollment [47][49] Question: Near-term trend of R&D spending - R&D spending is expected to be conservative, with completed capital spend on HONEDRA and limited costs anticipated for the DKD study [51] Question: Clarity on CMD program enrollment - Enrollment challenges are attributed to COVID-19 impacts on hospital staffing and changes in diagnostic technology, with hopes for improvement by late summer or early fall [55][60] Question: Stock repurchase consideration - Management believes that developing assets is a better use of capital than repurchasing stock, as share price is currently tied to cash balance [62][63] Question: Future direction regarding assets or corporate acquisitions - The company is evaluating both asset acquisitions and potential corporate purchases, depending on the situation and available opportunities [65]