Peter Enderlin

Sara Nik

Will Hidell

Brian Kemp Dolliver

Joe Pantginis

Stephen Brozak

- Lisada Therapeutics (LSTA) is a clinical-stage pharmaceutical company primarily focused on **solid tumor cancer**, with its lead product, sotepatide, demonstrating promising results in clinical trials.  **[0000320017_2191589_0]** **[0000320017_2191589_1]** 
- The company reports a **cash runway through early 2027** and holds over **$20 million in cash** on its balance sheet, with no debt.  **[0000320017_2191589_0]** **[0000320017_2191589_5]** 
- Sotepatide has completed Phase 2B trials and is **Phase 3 ready for metastatic pancreatic ductal adenocarcinoma (MPDAC)**, showing significant improvements in overall survival and complete responses in Phase 2B data.  **[0000320017_2191589_2]** **[0000320017_2191589_3]** 
- Lisada has secured **Fast Track and Orphan Drug designations** for sotepatide in pancreatic cancer in the US and Europe, and has an FDA-approved Phase 3 design.  **[0000320017_2191589_4]** 
- The company has established several strategic alliances, including a global license with **Catalent** and a license in Greater China with **Chivu Pharmaceutical**, and is actively seeking partners for further development.  **[0000320017_2191589_1]** **[0000320017_2191589_4]** **[0000320017_2191589_5]**

Lisada Therapeutics (LSTA) provides update on clinical progress, financial position, and strategic partnerships

- Lisata Therapeutics (LSTA) is a **clinical-stage pharmaceutical company** focused on solid tumor cancers, with its lead product being **SERTEPATIDE**, a proprietary internalizing RGD cyclic peptide designed to enhance the efficacy of other anti-cancer agents.  **[0000320017_2191830_1]** **[0000320017_2191830_2]** 
- The company has completed **Phase 2B trials** and is **Phase 3-ready** for metastatic pancreatic ductal adenocarcinoma, with clinical data showing significant improvements in overall survival and complete response rates.  **[0000320017_2191830_3]** **[0000320017_2191830_4]** **[0000320017_2191830_5]** 
- Lisata Therapeutics holds **Fast Track designation** and **Orphan Drug status** in the U.S. and Europe for pancreatic cancer, among other indications, and possesses a strong intellectual property portfolio protecting its products through **2040**.  **[0000320017_2191830_1]** **[0000320017_2191830_5]** 
- The company reported a **cash runway through early 2027**, with over **$20 million in cash** on the balance sheet and is debt-free.  **[0000320017_2191830_1]** **[0000320017_2191830_6]** 
- Strategic alliances include a recent global license with **Catalent** for ADCs in combination with SERTEPATIDE, and the company is actively seeking partners to complete Phase 3 development.  **[0000320017_2191830_2]** **[0000320017_2191830_5]** **[0000320017_2191830_6]**

Lisata Therapeutics Provides Update on SERTEPATIDE Development and Financial Position

- Certepetide, LSTA's proprietary iRGD cyclic peptide adjuvant, is designed to optimize solid tumor treatment by enhancing drug penetration, modifying the tumor microenvironment, and inhibiting metastasis.  **[320017_0000320017-25-000066_ex991lstacorporatepresen.htm:2]** **[320017_0000320017-25-000066_ex991lstacorporatepresen.htm:4]** 
- In the ASCEND Phase 2b study for metastatic pancreatic ductal adenocarcinoma (mPDAC), Cohort A showed a median overall survival (mOS) of **12.68 months** for Certepetide + SoC compared to **9.23 months** for SoC alone, while Cohort B demonstrated a median progression-free survival (mPFS) of **7.46 months** for Certepetide + SoC versus **5.29 months** for SoC alone.  **[320017_0000320017-25-000066_ex991lstacorporatepresen.htm:7]** **[320017_0000320017-25-000066_ex991lstacorporatepresen.htm:8]** 
- Certepetide has secured **FDA Fast Track Designation** for pancreatic cancer and **Orphan Drug Designations** for multiple indications, including pancreatic cancer, which provide regulatory benefits like accelerated approval and market exclusivity.  **[320017_0000320017-25-000066_ex991lstacorporatepresen.htm:10]** 
- Lisata Therapeutics has an agreed-upon **global Phase 3 study design with the FDA** for Certepetide in first-line mPDAC, targeting **657 patients** with overall survival as the primary endpoint.  **[320017_0000320017-25-000066_ex991lstacorporatepresen.htm:11]** 
- As of **June 30, 2025**, Lisata Therapeutics held **$22.0 million in cash and investments** with **no debt**, projecting a cash runway into **Q1 2027**.  **[320017_0000320017-25-000066_ex991lstacorporatepresen.htm:12]** **[320017_0000320017-25-000066_ex991lstacorporatepresen.htm:12]**

Lisata Therapeutics Updates on Certepetide Clinical Development and Financial Position

- Lisata Therapeutics, Inc. **(LSTA)** entered into a **worldwide Non-Exclusive License Agreement** with Catalent, Inc. on **October 8, 2025**.  **[320017_0000320017-25-000063_clbs-20251008.htm:1]** 
- Under the agreement, Lisata granted Catalent non-exclusive rights to utilize its novel iRGD cyclic peptide, **certepetide**, as an antibody drug conjugate (ADC) payload within Catalent's SMARTag® ADC platform.  **[320017_0000320017-25-000063_clbs-20251008.htm:1]** 
- Lisata is eligible to receive **up to $10.5 million** in aggregate pre-determined development milestone payments, in addition to tiered revenue sharing on future sales and/or partnerships.  **[320017_0000320017-25-000063_clbs-20251008.htm:1]** 
- Catalent will assume full responsibility for all research, development, and commercialization costs associated with the licensed intellectual property.  **[320017_0000320017-25-000063_clbs-20251008.htm:1]**

LISATA THERAPEUTICS (LSTA)