Lisata Therapeutics (LSTA) Q2 2024 earnings summary

Executive summary

• Advanced development of certepetide, a novel investigational product for solid tumors, with encouraging preclinical and clinical data and multiple global Phase 1b/2a and 2b trials ongoing, including ASCEND and BOLSTER.

• Certepetide received multiple regulatory designations, including FDA Fast Track, Orphan Drug, and Rare Pediatric Disease status for several indications, enhancing potential for accelerated approval and market exclusivity.

• Multiple product and business milestones are projected over the next 18 months, with key data readouts from ASCEND and BOLSTER trials expected in late 2024 and 2025.

• Strategic partnerships, including with Qilu Pharmaceutical in Greater China, have generated milestone payments and support global development.

• Seasoned management team with extensive international drug development and approval experience.

Financial highlights

• Operating expenses for Q2 2024 were $5.5 million, down 19.7% from $6.9 million in Q2 2023; R&D expenses decreased 17.7% to $2.6 million, and G&A expenses fell 21.3% to $2.9 million.

• Net loss for Q2 2024 was $5.0 million, compared to $4.0 million in Q2 2023; six-month net loss was $10.4 million versus $10.2 million year-over-year.

• Cash, cash equivalents, and marketable securities totaled $38.3 million as of June 30, 2024, with no debt, expected to fund operations into early 2026.

• Weighted average shares outstanding were 8.3 million for Q2 2024; 1.5 million options and 1.4 million warrants outstanding.

• Investment income contributed $0.5 million in Q2 2024; a $0.8 million income tax benefit was recorded from the sale of New Jersey NOLs.

Outlook and guidance

• Projected capital is expected to support all ongoing and planned clinical trials through anticipated data milestones into early 2026.

• Top-line data from ASCEND cohort A expected in Q4 2024, with full data from all 158 patients by mid-2025; BOLSTER trial top-line data expected mid-2025.

• Additional certepetide clinical milestones and data readouts anticipated through 2025.

• The company continues to seek additional capital through equity, partnerships, grants, and asset sales, but notes potential challenges in raising funds.