certepetide (LSTA1) / Qilu Pharma, Lisata Therap - LARVOL DELTA

LSTA1-GBM-2A: study protocol for an exploratory phase 2a randomised controlled trial evaluating tumour-homing peptide certepetide with temozolomide in glioblastoma multiforme. (PubMed, BMJ Open) - "The results of this study will be published in peer-reviewed journals and reported at academic conferences. 2023-506813-23-00."

Clinical protocol • Journal • P2a data • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

Lisata Therapeutics Highlights Positive Preclinical Data of Certepetide as Part of Antibody-Drug Conjugate Combinations as Reported by Licensing Partner Catalent (GlobeNewswire) - "Specifically, Catalent reported preclinical results showing that using certepetide as a non-cytotoxic ADC payload not only improved ADC efficacy but also broadened the distribution of the cytotoxic payload within the tumor microenvironment."

Preclinical • Oncology

AGITG ASCEND: Randomised, double-blind phase II trial of certepetide (CERT) or placebo (PLA) with gemcitabine (Gem) + nab-paclitaxel (Nab) in patients with untreated metastatic pancreatic ductal adenocarcinoma (mPDAC): Updated results including planned pooled placebo analysis (ESMO 2025) - P2 | "CERT is a proprietary iRGD targeting peptide that enhances drug penetration into tumor and stroma, potentially enhancing response. Adverse event severity and rates in the CERT treated subjects were comparable to those observed in the PLA treated subjects. Conclusions Addition of CERT to Gem/Nab demonstrated enhanced CR rate (5 CERT vs 0 PLA), improved ORR and encouraging signals of PFS and OS benefit, supporting a global phase 3 trial."

Clinical • Metastases • P2 data • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

CENDIFOX: Phase I/II Trial of CEND-1 (LSTA1, certepetide) with Neoadjuvant mFOLFIRINOX in Resectable and Borderline Resectable PDAC Free (AACRPanCa 2025) - P1/2 | "Certepetide combined with mFOLFIRINOX is safe and feasible in resectable PDAC. Encouraging early OS and PFS data, high pathologic partial response rates, and correlative immune findings support further evaluation in randomized trials. Enhancement of TAMs and PD-1/PD-L1 in the tumor microenvironment supports the potential to convert PDAC from an immune-cold to an immune-hot tumor, possibly sensitizing it to immunotherapy."

Clinical • IO biomarker • P1/2 data • Anorexia • Fatigue • Mucositis • Neutropenia • Pancreatic Cancer • Solid Tumor • CD68 • NRP1 • PD-1 • PD-L1

Lisata Therapeutics and Catalent Announce Global Antibody-Drug Conjugate (ADC) License Agreement (GlobeNewswire) - "Under the licensing agreement, Catalent gains worldwide, non-exclusive rights to develop and commercialize bioconjugate products containing certepetide and its analogs, including the ability to partner with third parties. As part of this collaboration, Catalent will have the right to evaluate certepetide and its analogs as SMARTag payloads in clinical studies across multiple ADCs targeting difficult-to-treat diseases, with the goal of creating a new class of targeted bioconjugate therapies. Lisata is eligible to receive over $10 million in tiered study initiation milestone payments plus revenue sharing on future sales and partnerships."

Licensing / partnership • Appendix Cancer • Cholangiocarcinoma • Colon Cancer • Osteosarcoma • Pancreatic Ductal Adenocarcinoma

Lisata Therapeutics Announces Encouraging Preliminary Results from the Pancreatic Cancer Cohort of the CENDIFOX Trial (GlobeNewswire) - "The preliminary data will be presented...at the American Association for Cancer Research (“AACR”) Special Conference....Among the 35 patients enrolled in the PDAC cohort, 10 completed the protocol-prescribed pre-surgical courses of therapy and were eligible to undergo pancreatic cancer resection. Based on these 10 patients, the R0 resection rate (no residual cancer at the surgical margins) was 50%, and 70% experienced a pathologic partial response. The results also demonstrated promising early survival data, including a 60% two-year overall survival rate and a 12-month median disease-free survival."

P1/2 data • Pancreatic Ductal Adenocarcinoma

Lisata Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "Final data and key findings from both cohorts of the ASCEND study are anticipated to be available later this year, with more information to follow as it becomes available....BOLSTER:...Lisata announced first patient treated in the second-line CCA cohort and recently decided to stop enrollment at approximately 20 patients to accelerate data readout and optimize capital allocation....CENDIFOX data are expected in the coming months; however, given that this is an investigator-initiated study, the exact timing is not in Lisata’s control."

Clinical data • Trial status • Appendix Cancer • Cholangiocarcinoma • Colon Cancer • Pancreatic Ductal Adenocarcinoma

Lisata Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "iLSTA: Phase 1b/2a randomized, single-blind, single-center, safety and pharmacodynamic trial in Australia...evaluating certepetide in combination with SoC chemotherapy (nab-paclitaxel and gemcitabine) plus SoC immunotherapy (durvalumab) versus SoC alone in patients with locally advanced non-resectable PDAC....Final data and key findings from this study are anticipated in the first quarter of 2026....A Lisata-funded Phase 2a, double-blind, placebo-controlled, randomized, proof-of-concept study evaluating certepetide in combination with SoC temozolomide versus temozolomide alone in patients with newly diagnosed glioblastoma multiforme ('GBM') is being conducted across multiple sites in Estonia and Latvia and is planned to also include a site in Lithuania. The study is targeted to enroll 30 patients with a randomization of 2:1 in favor of the certepetide treatment group. Enrollment completion is expected in 2026."

Enrollment status • P1/2 data • Glioblastoma • Pancreatic Ductal Adenocarcinoma

Activating immune engagement against pancreatic ductal adenocarcinoma (PDAC): Effect of LSTA-1 and durvalumab on tumour-infiltrating lymphocytes (TILs) (ESMO-GI 2025) - P1 | "Preliminary results demonstrated that the combination of gemcitabine and nab-paclitaxel with LSTA-1 and durvalumab appears to be associated with both an increase in tumour infiltrating lymphocyte response and a decrease in tumour size."

Tumor-infiltrating lymphocyte • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Lisata Therapeutics and WARPNINE Announce iLSTA Trial Enrollment Completion and Provide Preliminary Data Update (GlobeNewswire) - P1b/2a | N=30 | ACTRN12623000223639 | "Lisata Therapeutics...and WARPNINE...announced the successful completion of patient enrollment in the Phase 1b/2a iLSTA trial (ACTRN12623000223639) in Australia....The updated preliminary data from the iLSTA trial, presented at the 2025 ESMO Gastrointestinal Cancers (ESMO-GI) Congress on July 3, 2025, demonstrated an overall response rate of 60% and an overall disease control rate of 100%. After 4 treatment cycles, 13/20 participants showed a RECIST partial response (11 patients in Cohort 3), and 1 participant (Cohort 2) exhibited a RECIST complete response. The remaining 6 participants demonstrated stable disease (90% reduction (5 patients in Cohort 3) and 9 participants showing a >50% reduction in CA19-9 levels (6 patients in Cohort 3)."

Enrollment closed • P1/2 data • Pancreatic Ductal Adenocarcinoma

Lisata Therapeutics Expands Intellectual Property Portfolio with New Composition of Matter Patent for Certepetide (GlobeNewswire) - "Lisata Therapeutics...announced that the United States Patent and Trademark Office ('USPTO') issued the Company a new composition of matter patent for certepetide through March 2040, with subsequent opportunity for patent term extension....The U.S. Patent No. 12,351,653 includes claims to certepetide’s chemical structure, pharmacokinetic properties, methods of manufacturing, and applications for treating solid tumor cancers. For Lisata, securing this patent is profoundly significant as it not only strengthens Lisata’s robust IP estate..."

Patent • Solid Tumor

AGITG ASCEND study: Randomised, double-blind phase II study of certepetide (CERT) or placebo (PLA) added to gemcitabine plus nab-paclitaxel in patients with untreated metastatic pancreatic ductal adenocarcinoma (mPDAC): Cohort B progression-free survival (PFS) results (ESMO-GI 2025) - P2 | "Background: CERT (aka LSTA1 or CEND-1) is a novel cyclic peptide that improves penetration of co-administered drugs into tumour and stroma, potentially leading to increased anti-neoplastic activity. Double-dose CERT + GEM/NPC demonstrated trends for a clinically meaningful PFS and ORR improvements in mPDAC, with a manageable safety profile. The 6-mo PFS rate (60.8%) supports further investigation of CERT as a novel therapeutic agent in mPDAC."

Clinical • Metastases • P2 data • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Positive Preliminary Cohort B Results from the AGITG-led ASCEND Trial to be Presented at ESMO GI Evaluating Lisata’s Certepetide in Combination with Standard-of-Care Chemotherapy in Metastatic Pancreatic Cancer (GlobeNewswire) - P2b | N=158 | ASCEND (NCT05042128) | "The preliminary data from Cohort B demonstrate a six-month progression-free survival ('6MPFS') of 60.8% for the certepetide-treated group, whereas the 6MPFS in the placebo-treated group was 25%. Median progression-free survival ('mPFS') was 7.5 months for the certepetide-treated group and 4.7 months for the placebo-treated group. Objective response rate ('ORR') was 45.2% for the certepetide-treated group and 19% for the placebo-treated group. Median overall survival ('mOS') was 10.32 months for the certepetide-treated group compared to 9.23 months for the placebo-treated group. A comparison of data from Cohort A and Cohort B indicates that the addition of two doses of certepetide (Cohort B regimen) to SoC chemotherapy resulted in a clinically meaningful improvement in both PFS and ORR for patients with mPDAC....Final data and key findings from both cohorts of the ASCEND study are anticipated to be available later this year..."

P2b data • Pancreatic Ductal Adenocarcinoma

BOLSTER: A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=67 | Active, not recruiting | Sponsor: Lisata Therapeutics, Inc. | Trial completion date: Mar 2026 ➔ Mar 2030 | Trial primary completion date: Apr 2025 ➔ Apr 2026

Trial completion date • Trial primary completion date • Biliary Cancer • Cholangiocarcinoma • Esophageal Squamous Cell Carcinoma • Gallbladder Cancer • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

FORTIFIDE: Certepetide Phase 1b/2a Continuous Infusion Trial in mPDAC (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Lisata Therapeutics, Inc. | Trial completion date: Apr 2025 ➔ Jan 2040 | Initiation date: Jan 2025 ➔ Jan 2030 | Trial primary completion date: Apr 2025 ➔ Jan 2035

Trial completion date • Trial initiation date • Trial primary completion date • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

FORTIFIDE: Certepetide Phase 1b/2a Continuous Infusion Trial in mPDAC (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Lisata Therapeutics, Inc. | N=30 ➔ 0 | Trial completion date: Sep 2027 ➔ Apr 2025 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Sep 2027 ➔ Apr 2025

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

BOLSTER: A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=67 | Active, not recruiting | Sponsor: Lisata Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Mar 2026 ➔ Apr 2025

Enrollment closed • Trial primary completion date • Biliary Cancer • Cholangiocarcinoma • Esophageal Squamous Cell Carcinoma • Gallbladder Cancer • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Lisata Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "Development Portfolio Highlights:... (i) iLSTA: Phase 1b/2a randomized, single-blind, single-center, safety and pharmacodynamic trial in Australia...With 27 of the 30 patients enrolled, enrollment remains on track to be completed by the first half of 2025; (ii) A Lisata-funded Phase 2a, double-blind, placebo-controlled, randomized, proof-of-concept study evaluating certepetide in combination with SoC temozolomide versus temozolomide alone in patients with newly diagnosed glioblastoma multiforme (GBM) is being conducted across multiple sites in Estonia and Latvia and is planned to also include a site in Lithuania....Enrollment completion is now expected in 2026; (iii) FORTIFIDE:...Initiation of the study remains on hold as the Company is investigating a potentially faster and more cost-effective alternative to achieve the study’s objective, which may become the preferred strategy."

Trial status • Glioblastoma • Pancreatic Ductal Adenocarcinoma

Lisata Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "Development Portfolio Highlights:...CENDIFOX: Phase 1b/2a open-label trial in the U.S. evaluating certepetide in combination with neoadjuvant FOLFIRINOX based therapies in pancreatic, colon and appendiceal cancers....CENDIFOX data are expected in the coming months; however, given that this is an investigator-initiated study, the exact timing is not in Lisata’s control....Qilu Pharmaceutical, the licensee of certepetide in the Greater China territory, is currently evaluating certepetide in combination with gemcitabine and nab-paclitaxel as a treatment for first-line mPDAC....Qilu has completed enrollment in its Phase 2 trial and data are expected in the near future. Progression of Qilu’s certepetide development program into Phase 3 in China will trigger a $10 million milestone payment due to Lisata under the terms of the license agreement with Qilu."

Clinical data • Enrollment status • Financing • Appendix Cancer • Colon Cancer • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Lisata Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "Development Portfolio Highlights:...(i) ASCEND: Phase 2b double-blind, randomized (2:1 ratio), placebo-controlled trial evaluating two dosing regimens of certepetide in combination with SoC chemotherapy (gemcitabine/nab-paclitaxel) in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC)....Preliminary results from Cohort B data have been accepted for presentation at the ESMO Gastrointestinal Cancers Congress being held July 2-5, 2025...; (ii) BOLSTER: Phase 2a double-blind, placebo-controlled, multi-center, randomized trial in the U.S. evaluating certepetide in combination with SoC chemotherapy in first- and second-line cholangiocarcinoma (CCA). The Company achieved complete enrollment in first-line CCA nearly six months ahead of plan, accelerating anticipated topline data readout to mid-2025."

Enrollment status • P2 data • Cholangiocarcinoma • Pancreatic Ductal Adenocarcinoma

Lisata Therapeutics Announces Research License with Catalent (GlobeNewswire) - "Lisata Therapeutics, Inc...today announced that the Company has entered into a research license with Catalent, Inc...to evaluate, in a preclinical setting, the efficacy of Lisata's iRGD cyclic peptide product candidate, certepetide, as a payload used in the context of Catalent’s SMARTag antibody-drug conjugate ('ADC') dual-payload technology platform for the treatment of difficult-to-treat-diseases, including advanced solid tumors. Under the terms of the agreement, Catalent will assume full responsibility for all research and development expenses and Lisata will provide consulting support. Further, Lisata will receive an upfront payment with the possibility of future considerations contingent upon the results of the preclinical evaluation....The combination of ADCs and certepetide could revolutionize precision oncology delivering targeted therapies deep within tumors for improved efficacy with reduced systemic toxicity."

Licensing / partnership • Preclinical • Solid Tumor

Lisata Therapeutics and GATC Health Consummate First Step in Strategic Collaboration to use AI to Derisk and Accelerate Drug Development (GlobeNewswire) - "Lisata Therapeutics, Inc...and GATC Health Corp...announced the consummation of the first step of an intended multi-part strategic agreement. Under terms of the agreement, the two companies will leverage Lisata’s experience and expertise in drug development together with GATC’s proprietary AI-powered and validated Mutiomics Advanced Technology ('MAT') platform to derisk, optimize, and accelerate drug development, creating opportunities with a higher probability of success. As the first step in the collaboration, GATC’s MAT AI platform will analyze Lisata’s investigational drug, certepetide, to identify optimized and derisked development opportunities across various indications....Based on the outcome of GATC’s analysis, Lisata plans to optimize its Phase 3 development of certepetide in metastatic pancreatic ductal adenocarcinoma ('mPDAC') while also identifying new indications with a high probability of development success."

Licensing / partnership • Pancreatic Ductal Adenocarcinoma

Lisata Therapeutics Reports Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "BOLSTER: Phase 2a double-blind, placebo-controlled, multi-center, randomized trial in the U.S. evaluating certepetide in combination with SoC chemotherapy in first- and second-line cholangiocarcinoma (CCA)....In September 2024, Lisata announced first patient treated in the second-line CCA cohort, with enrollment completion targeted for later this year; Qilu Pharmaceutical, the licensee of certepetide in the Greater China territory, is currently evaluating certepetide in combination with gemcitabine and nab-paclitaxel as a treatment for first-line mPDAC....Qilu has completed enrollment in its Phase 2 trial and data are expected in the coming months."

P2 data • Trial status • Cholangiocarcinoma • Pancreatic Ductal Adenocarcinoma

Lisata Therapeutics Reports Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "FORTIFIDE: Phase 1b/2a, double-blind, placebo-controlled, three-arm, randomized study in the U.S. evaluating the safety, tolerability, and efficacy of a 4-hour continuous infusion of certepetide in combination with SoC in subjects with first-line mPDAC....The Company expects to enroll the first patient in the study in the first half of 2025."

Trial status • Pancreatic Ductal Adenocarcinoma

Lisata Therapeutics Reports Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "iLSTA: With 27 of the 30 patients enrolled, enrollment remains on track to be completed by the first half of 2025; A Lisata-funded Phase 2a, double-blind, placebo-controlled, randomized, proof-of-concept study evaluating certepetide in combination with SoC temozolomide versus temozolomide alone in patients with newly diagnosed glioblastoma multiforme (GBM) is being conducted across multiple sites in Estonia and Latvia and is planned to also include a site in Lithuania."

Enrollment status • Glioblastoma • Pancreatic Ductal Adenocarcinoma