LISATA THERAPEUTICS, INC. Q1 FY2024 earnings call

• Progress on certepetide: Continues development in combination with anticancer agents for solid tumors. Encouraging preclinical and early clinical data support its potential in revising standard of care. • Milestone: Certepetide obtained official INN, USAN, and AAN names, a step toward commercialization. • Clinical programs: - ASCEND trial: 158-patient double-blind, placebo-controlled trial in mPDAC; enrollment completed Q4 2023, top-line data from Cohort A expected Q4 2024. - BOLSTER trial: Refocused on first-line cholangiocarcinoma, making significant enrollment progress; considering amendment for second-line treatment. - CENDIFOX study: Phase 1b/2a open-label trial in pancreatic, colon, and appendiceal cancers, expected to complete enrollment by end-2024. - iLSTA trial: Phase 1b/2a safety and efficacy trial in Australia, enrollment completion expected H2 2024. - iGoLSTA study: Pending initiation for gastroesophageal adenocarcinoma. - GBM trial: Phase 2a double-blind placebo-controlled study in Estonia and Latvia, 3 patients enrolled with safety observation period ending soon. • Mechanism of action: Certepetide targets integrins to deliver anticancer drugs through stroma into tumor. • Regulatory strategy: Pursuing special designations, priority reviews, and accelerated approvals, including orphan designations and rare pediatric disease designation for osteosarcoma.

For the 3 months ended March 31, 2024, operating expenses totaled $6.6 million, a decrease of $0.2 million (3.6%) compared to $6.8 million in Q1 2023. Research and development expenses were approximately $3.2 million in both Q1 2024 and Q1 2023. General and administrative expenses were $3.4 million in Q1 2024, a decrease of $0.3 million (8.3%) from $3.7 million in Q1 2023. As of March 31, 2024, Lisata had cash, cash equivalents, and marketable securities of approximately $43.3 million. The company believes available capital will fund operations into early 2026.

• Available capital is expected to fund operations into early 2026, covering anticipated data milestones from ongoing and planned trials. • Potential milestone payments from Qilu's trials dependent on their execution, including for technology transfer, Phase 3 initiation, and registration. • Anticipation of data from ASCEND trial in Q4 2024 and potential earlier data from BOLSTER trial if enrollment progresses faster.

• General risks associated with forward-looking statements and uncertainties regarding operations and future results, as outlined in the company's SEC filings. • Uncertainties in clinical trial timelines and outcomes due to investigator-initiated trials and potential changes in regulatory requirements.

Q: Regarding certepetide and GBM, when might enrollment completion be reached and will there be early data cuts?

A: The GBM trial has 3 patients enrolled; the last subject is 2 weeks into a 30-day safety observation period. Enrollment expected to pick up within 2-3 weeks. The trial is blinded with no early breaking of the blind for data cuts; will wait until all 40 patients are enrolled and endpoints reached.

Q: Why does the Qilu trial need 18 months to enroll?

A: Qilu's trials are run exclusively by Qilu. They communicated a projection of 18 months for enrollment, but execution is within their purview and they may enroll faster.

Q: About the shelf registration, what's the use?

A: It's housekeeping; the previous shelf was expiring, and keeping a shelf allows flexibility for financing and other opportunities.

Q: Cost of standard care for pancreatic cancer?

A: Typical regimen of gemcitabine nab-paclitaxel is around $60,000. Our product is a small cyclic peptide with a reasonable cost compared to expensive immunotherapies and CAR-T therapies.

Q: Anticipation of milestone payments?

A: Milestone payments exist for activities like technology transfer, Phase 3 initiation, and registration, dependent on Qilu's execution; results in China could lead to earlier milestones.

Q: Timeline for BOLSTER trial data release?

A: With enrollment target of end-2024, data expected to be announced before end-2025, potentially earlier if enrollment progresses faster