LISATA THERAPEUTICS, INC. Q4 FY2023 earnings call

• David Mazzo introduced the call, highlighting progress in clinical development with LSTA-1.
• James Nisco discussed financial results, noting decreases in operating, R&D, and G&A expenses.
• Kristen Buck provided an overview of the clinical pipeline for LSTA1, including details on trials like ASCEND, BOLSTER, CENDIFOX, and others, emphasizing progress in enrollment and expected data readouts.

Operating expenses for the year ended December 31, 2023, totaled $25.7 million compared to $57.6 million in 2022, a decrease of 55.4%. Research and development expenses were $12.7 million in 2023 vs $13.1 million in 2022, a decrease of ~$300,000 or 2.5%. General and administrative expenses were $13 million in 2023 vs $14.1 million in 2022, a decrease of ~$1.2 million or 8.3%. Net losses were $20.8 million in 2023 vs $54.2 million in 2022. As of December 31, 2023, cash, cash equivalents, and marketable securities were approximately $50.5 million. The company believes its projected capital will fund operations into early 2026.

• The company's cash is expected to fund operations into early 2026.
• ASCEND trial full enrollment achieved, top-line data expected in Q4 2024, complete data by mid-2025.
• BOLSTER enrollment completion expected by end of 2024.
• CENDIFOX enrollment completion expected by end of Q2 2024.
• Qilu's Phase 2 trial in China expected to start shortly after final data in Q2 2024.

• Forward-looking statements involve risks and uncertainties.
• Clinical trial timelines and outcomes are subject to change.
• Dependence on funding from partners like WARPNINE and others.

Q: Insight on BOLSTER trial enrollment regions.

A: The US was the initial contributor to enrollment, but European sites will come online in March, with expected significant contribution from Europe in Q2 2024.

Q: Milestones for ASCEND trial enrollment.

A: No milestones, as the trial is funded by Lisata.

Q: WARPNINE's financial resources.

A: WARPNINE is a philanthropic foundation, has met commitments so far.

Q: AGITG financial interest.

A: AGITG has no financial interest, purely clinical execution.

Q: Significance of 4-hour delay in ASCEND cohort B.

A: Combination of pharmacokinetic/pharmacodynamic knowledge and patient practicality.

Q: Business model for co-administered drugs.

A: Products sold separately, possible bundling in future.

Q: WARPNINE funding timeline.

A: WARPNINE has met commitments, efficient in funding.

Q: R&D credits and runway.

A: $600k received in 2023 for 2022 tax year, ~$1M expected in 2024, included in the projected runway.

Q: Qilu's Phase 3 milestone.

A: Qilu is contractually obliged to a $10M milestone on Phase 3 start, with Phase 2 expected in Q2 2024.