Lisata Therapeutics, Inc. Q1 FY2025 earnings call

• David Mazzo noted maintaining momentum in 2025 despite market headwinds and progress with Certepetide clinical data from ASCEND and iLSTA trials presented at ASCO GI Symposium.
• Kristen Buck provided updates on development programs:
  • ASCEND trial for mPDAC with Cohort A preliminary data showing positive survival trend and Cohort B data delayed but to be presented at ESMO Gastrointestinal Cancer Congress.
  • Bolster trial for cholangiocarcinoma with second-line cohort enrollment capped at 20 patients to accelerate data readout.
  • CENDIFOX trial with enrollment completed in all cohorts, awaiting data.
  • Qilu Pharmaceutical's parallel program for mPDAC with enrollment completed, data expected in 12-18 months and Phase 3 planned.
  • iLSTA trial with promising preliminary results and near enrollment completion.
  • GBM study initiated with patients enrolled.
  • Collaborations with Valo Therapeutics, Kuva Labs, and Catalent for various preclinical and clinical explorations.

For the three months ended March 31, 2025, operating expenses totaled $5.8 million, down from $6.6 million in Q1 2024. Research and development expenses were $2.6 million (down from $3.2 million in Q1 2024), a decrease of $0.6 million or 19.7%, primarily due to reduced clinical research organization and site expenses. General and administrative expenses were $3.2 million (down from $3.4 million in Q1 2024), a decrease of ~$0.1 million or 3.4%, due to prior year one-off settlement costs offset by increased consulting and severance costs. Net losses were $4.7 million in Q1 2025, down from $5.4 million in Q1 2024. As of March 31, 2025, Lisata had cash, cash equivalents, and marketable securities of approximately $25.8 million, with available funds expected to support operations into Q3 2026.

• Anticipate a data-rich 2025 with key milestones and data readouts for various Certepetide studies.
• Expect progress toward realizing the transformative potential of Certepetide as reported on future calls.

Q: Regarding the Bolster study's second line cholangiocarcinoma cohort with capped enrollment, how does this impact the regulatory path forward?

A: The Bolster trial is a phase 2a proof-of-concept trial not powered to specific endpoints. Enrolling 20 patients in the second line with a control in both arms allows determination of therapeutic trends with the same confidence as 40 patients, and data will be available faster by curtailing enrollment.

Q: On Qilu's phase 2 data expected in the near future, how does their timeline align with innovation pathways?

A: Qilu is in China's innovation pathway, which requires being first to approve in China for maximum benefits. Their decisions are driven by moving quickly to confirm trends and secure innovation pathway benefits, potentially cutting short timelines to move to phase 3.

Q: About manufacturing Certepetide for trials with big pharma manufacturers: Is there activity along this line?

A: Big pharma typically manage manufacturing capacity closely and don't function as contract manufacturers for small quantities unless they've signed deals, licensed, or acquired the product. Switching products in their facilities is costly and time-consuming, so they don't allocate capacity for small quantities of external products.

Q: Activity in endometriosis partnerships?

A: Discussions in endometriosis are very early, based on preliminary mouse study data, but potential partners are more interested in clinically ready assets currently.

Q: Tethered administration of Certepetide?

A: There's a collaboration with Catalent for Certepetide to be tethered to Catalent’s SMARTag ADC platform for delivery and therapeutic effect.