certepetide (LSTA1) / Lisata Therapeutics - LARVOL DELTA

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

Tumor-homing peptides in precision oncology: Mechanisms, design and recent advances. (PubMed, J Control Release) - "We analyze the structural and functional biology of the predominant internalization pathways like the Neuropilin-1 (NRP-1) dependent C-end Rule (CendR) and the Sortilin (SORT1) scavenger receptor, and their use to promote deep tissue penetration. Finally, we assess the translational landscape of early 2026, including the recent FDA withdrawal of the lipophilic peptide-conjugated melphalan flufenamide (Pepaxto®) and the recent clinical success of the cyclic peptide certepetide for pancreatic adenocarcinoma and the ongoing promising studies with chemically constrained bicyclic peptides."

Journal • Review • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Targeted Protein Degradation • NRP1 • SORT1

Targeting the neuropilin 1/interferon γ axis restores glucocorticoid-suppressed T cell function and rescues bone formation to prevent steroid-induced osteonecrosis. (PubMed, Bone Joint Res) - "Glucocorticoids suppress T cell-derived IFNγ via NRP1 upregulation, thereby impairing Runx2 nuclear translocation and BMSC osteogenesis. Sec2 counteracts this cascade through antigen-presenting cell modulation, restoring the NRP1/IFNγ axis to preserve femoral head integrity."

Journal • Infectious Disease • CD8 • IFNG • NRP1 • RUNX2 • STAT1

Initial results of the iLSTA study: Effect of certepetide (LSTA-1) combined with immunotherapy and chemotherapy for locally advanced PDAC (ESMO-GI 2026) - "Methods This study assessed safety, feasibility and efficacy of certepetide plus gemcitabine, nab-paclitaxel and durvalumab in PDAC patients. Disease control rate was 100.0%, with ORR of 64%. Conclusions The novel agent certepetide is safe, tolerable and effective when added to PDAC chemo-immunotherapy, with notable RECIST and TIL responses observed in participant tumours."

Metastases • Gastrointestinal Cancer • Pancreatic Ductal Adenocarcinoma • CD8

Effect of the human gut microbiome on tumour response to anti-cancer treatment in PDAC patients: An iLSTA sub-study (ESMO-GI 2026) - "24 participants with locally advanced PDAC received combinations of gemcitabine, nab-paclitaxel, certepetide and durvalumab...The addition of immunotherapy was beneficial. We believe this study to be one of the first prospective, in-human studies to investigate the gut microbiome's effect on tumour response and treatment efficacy."

Clinical • Gastrointestinal Cancer • Oncology • Pancreatic Ductal Adenocarcinoma

Effect of certepetide on immune system engagement in PDAC: ILSTA substudy (ESMO-GI 2026) - "Certepetide (LSTA-1), an iRGD peptide, can promote trans-endothelial migration of CD8+ T cells via selective targeting of endothelial cell receptors to potentially overcome immune exclusion...Participants with locally advanced PDAC were divided into 3 cohorts and received varying combinations of gemcitabine (1000mg/m 2 ), nab-paclitaxel (125mg/m 2 ), durvalumab (750mg) and certepetide (3.2mg/kg)...Conclusions This was the first in-human, prospective study on the effect of certepetide on TIL response in PDAC tumours. Initial results suggest a correlation between certepetide administration, an increase in CD8+ T cell infiltration and tumour response."

First-in-human • Gastrointestinal Cancer • Pancreatic Ductal Adenocarcinoma • CD8

Lisata Therapeutics Announces Commencement of Tender Offer by Kuva Labs Inc. (GlobeNewswire) - "...Kuva will commence a tender offer to acquire all the issued and outstanding shares of Lisata common stock for: $4.00 per share in cash....The CVR entitles the holders of record to receive an additional cash payment of $1.25 per share, upon the achievement of, with respect to a Phase 2a, double-blind, placebo-controlled, randomized, proof-of-concept study evaluating LSTA1 when added to standard of care (temozolomide) versus temozolomide and matching LSTA1 placebo in subjects with newly diagnosed Glioblastoma Multiforme (GBM) (Protocol Number: LSTA1-GBM-2A), (i) completion of enrollment of such trial, (ii) the enrollment of at least 90% of the target number of subjects of such trial or (iii) the termination of such trial by its sponsor for any reason...and an additional cash payment of $1.75 per share upon the achievement of with respect to any product candidate referred to as of the date of the merger agreement..."

Commercial • Glioblastoma

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=66 | Terminated | Sponsor: Lisata Therapeutics, Inc. | Trial completion date: Mar 2030 ➔ Apr 2026 | Active, not recruiting ➔ Terminated; The study was halted prematurely to allow analysis of the results.

Trial completion date • Trial termination • Biliary Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology • Solid Tumor

Lisata Therapeutics Enters into Definitive Agreement to be Acquired by Kuva Labs, Inc. (GlobeNewswire) - "Under the terms of the merger agreement, Kuva will commence a tender offer to acquire all the issued and outstanding shares of common stock of the Company for $5.00 per share in cash payable at closing plus one contingent value right ('CVR') per share (the 'Transaction'). The CVR entitles the holders of record to receive an additional cash payment of $1.00 per share if a New Drug Application or similar registration is filed or formally accepted for review by the FDA or any governmental authority in any jurisdiction with respect to any pharmaceutical product that contains or incorporates the product candidate referred to as of the date of the merger agreement as certepetide for any indication or patient population..."

M&A • Solid Tumor

ASCEND: A Randomised, Double-blinded Phase II Study of Gemcitabine and Nab-Paclitaxel with CEND-1/LSTA1 (Certepetide) or Placebo in Patients with Untreated Metastatic Pancreatic Ductal Adenocarcinoma (ANZCTR) - P2 | N=155 | Completed | Sponsor: Australasian Gastro-Intestinal Cancer Trials Group | Active, not recruiting ➔ Completed

Trial completion • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Lisata Therapeutics Announces Mutual Termination of License Agreement with Qilu Pharmaceutical for Certepetide (The Manila Times) - "Lisata regains full development rights to certepetide in the Greater China Region...This action results in all licenses and other rights granted to Qilu reverting to Lisata....Notwithstanding, Qilu maintains its obligations, regulatorily or otherwise, to complete and wind down their ongoing Phase 2 clinical study (NCT06261359) evaluating certepetide in combination with standard-of-care chemotherapy in metastatic pancreatic ductal adenocarcinoma. Lisata has agreed to negotiate with Qilu the potential licensing of relevant study data from this trial, as appropriate."

Commercial • Trial status • Glioma • Osteosarcoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Lisata Therapeutics Enters Into Term Sheet to be Acquired by Kuva Labs for $4.00 Per Share in an All-Cash Tender Offer (GlobeNewswire) - "The Company and Kuva expect to enter into a definitive purchase agreement prior to February 27, 2026....The $4.00 per share cash offer price represents an approximate 85% premium and, including both CVRs, an approximate 180% premium to Lisata’s most recent closing stock price and reflects the strategic value of the Company's clinical pipeline and the breakthrough potential of its lead product candidate, certepetide."

M&A • Solid Tumor

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....The Company expects to announce numerous milestones over the next 1.5 years and believes that its projected capital will fund operations into the fourth quarter of 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials."

P1/2 data • Pancreatic Ductal Adenocarcinoma

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 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

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