Lisata Therapeutics (LSTA) Q3 2024 earnings summary

Executive summary

• Advanced development of certepetide (also referred to as sirtepotide) in combination with anti-cancer agents for solid tumors, with accumulating preclinical and clinical data supporting its potential as a new standard of care in multiple cancers, including pancreatic, cholangiocarcinoma, glioblastoma, colon, appendiceal, and melanoma.

• Initiated preclinical investigation of certepetide for endometriosis, targeting a significant unmet need in women's health.

• Multiple ongoing and planned Phase 2a/2b clinical trials, with several key data readouts and milestones anticipated between 4Q2024 and 1Q2026.

• Certepetide has received FDA Fast Track, Rare Pediatric Disease, and multiple Orphan Drug designations, providing regulatory and financial benefits.

• The company is pursuing out-licensing and partnership opportunities to advance its proprietary pipeline and achieve commercialization.

Financial highlights

• Operating expenses for Q3 2024 were $5.3 million, down 10.5% from $6.0 million in Q3 2023, driven by a 24.8% reduction in R&D expenses and a slight increase in G&A costs.

• Net loss for Q3 2024 was $4.9 million, compared to $5.3 million in Q3 2023; net loss for the nine months ended September 30, 2024 was $15.4 million, nearly flat year-over-year.

• Cash, cash equivalents, and marketable securities totaled $35.9 million as of September 30, 2024, with no debt and working capital of $33.0 million.

• Net cash used in operating activities for the nine months ended September 30, 2024 was $14.8 million, a decrease from $16.0 million in the prior year period.

• 8.3 million common shares and 1.5 million options outstanding as of September 30, 2024.

Outlook and guidance

• Projected capital is expected to fund operations into early 2026, covering anticipated data milestones from all ongoing and planned clinical trials.

• Multiple key clinical and preclinical data readouts are expected throughout 2025, including interim and final analyses from ASCEND, BOLSTER, and other trials.

• Future capital needs will depend on clinical progress, strategic transactions, and ability to secure partnerships or non-dilutive funding.