On November 7, 2025 Onchilles Pharma, a private biotech company pioneering next-generation cytotoxic therapeutics that harness the ELANE pathway, reported the publication of foundational preclinical data in Cell Reports Medicine, the closing of a $25 million Series A1 financing to advance its lead drug candidate, N17350, through clinical proof-of-concept, and the appointment of Thomas A. Buchholz, M.D., a global leader in breast cancer clinical research, as a clinical advisor. N17350 is a tumor-directed biologic that leverages the ELANE pathway to selectively kill cancer cells, while sparing healthy tissue and activating a systemic immune response.

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N17350 Demonstrates Broad, Selective, Immune-Activating Tumor Killing via the ELANE Pathway in Preclinical Studies

The published study in Cell Reports Medicine presents the most comprehensive validation to date of the ELANE pathway as a cancer-selective immune-activating mechanism. N17350 demonstrated consistent monotherapy efficacy, immune cell sparing, and durable responses across 30 cancer cell lines and 15 in vivo models, including chemotherapy-resistant cells and immunologically "cold" tumors. The data highlight N17350’s ability to drive both direct tumor killing and CD8+ T cell–mediated immune activation, in part, by leveraging elevated histone H1 levels, a feature of many malignant cancer cells.

"This research publication is the culmination of years of rigorous translational work to understand and harness the ELANE pathway as the foundation for a new era of cancer treatment," said Lev Becker, Ph.D., Co-Founder and Chief Scientific Officer of Onchilles Pharma. "Our lead drug candidate, N17350, has demonstrated rapid, selective tumor killing and immune activation across models of breast, lung, ovarian, colon, and other cancers. We believe our next-generation cytotoxic therapeutics that harness the ELANE pathway offer a compelling new treatment breakthrough that combines cytotoxic activity with immune-preserving activity and the potential to address a broad range of solid tumors."

N17350 Enters Clinical Testing with Potential to Redefine Cytotoxic Cancer Therapy

Onchilles plans to initiate a first-in-human trial of N17350, a tumor-directed injectable, in patients in Australia early next year, with IND clearance in the United States and U.S. patient enrollment expected in mid-2026. The study will evaluate safety, monotherapy activity, and biomarkers of immune activation across multiple solid tumor types, including breast, skin, and head and neck cancers.

N17350 is designed to deliver two mechanistic waves of anti-cancer activity: direct tumor killing through mitochondrial and DNA damage and systemic immune activation through immunogenic cell death. In preclinical models, this mechanism has generated durable remissions, immune memory, and synergy with checkpoint inhibitors.

The company has completed a successful GMP manufacturing campaign with over 5,000 doses of N17350 available for clinical use and has observed a favorable safety profile in preclinical studies, supporting the transition into human trials.

Funding Secured to Deliver Clinical Proof-of-Concept for N17350 in 2026

The company also announced the close of a $25 million Series A1 financing round to fund the N17350 program through clinical proof-of-concept, bringing the total raised in Series A funding to $40 million. Onchilles is also advancing NEU-002, a systemically delivered version of the therapy, which is on track for development candidate nomination in early 2026.

"Our new data and this financing further validate the ELANE pathway as a powerful cancer-selective mechanism with broad therapeutic potential," said Court R. Turner, J.D., Co-Founder and Chief Executive Officer of Onchilles. "We are well-positioned to demonstrate clinical activity, and if that data looks anything like our preclinical results, we believe N17350 could represent a breakthrough therapeutic class with relevance across a variety of solid tumors."

The round included new investors, Invivium Capital, Kennedy Lewis Investment Management, and UCM Ventures (a venture investment vehicle of the University of Chicago Medical Center), and existing investors, LYZZ Capital Advisors and Lincoln Park Capital Fund, LLC.

Dr. Thomas Buchholz Appointed Clinical Advisor to Guide Development for N17350

Onchilles also announced the appointment of Dr. Thomas A. Buchholz as a clinical advisor. A leading authority in breast cancer clinical trial strategy and neoadjuvant therapy development, Dr. Buchholz previously served as co-chair of the NCI’s Breast Cancer Steering Committee and held multiple leadership roles at The University of Texas MD Anderson Cancer Center.

Dr. Buchholz is advising Onchilles on early clinical development strategy, including potential applications of N17350 in neoadjuvant settings such as hormone receptor–positive and triple-negative breast cancers, where early data suggest the potential to eliminate tumors prior to surgery, reduce recurrence risk, and minimize the need for long-term hormone therapy.

About Onchilles Therapeutic Programs Targeting the ELANE Pathway

At the core of this approach is the ELANE pathway, a unique cancer-selective killing mechanism that leverages a vulnerability shared by many cancer cell types: elevated histone H1 levels. By targeting the ELANE pathway and inducing immunogenic cancer cell death, N17350 (NEU-001) and NEU-002 are designed to rapidly eliminate tumors while mobilizing an adaptive immune response, offering the potential for sustained anti-tumor immunity. N17350 and NEU-002 offer a unique approach to treating cancer regardless of their genetic makeup, anatomical origin, or immune status, positioning them as potential game-changers in cancer therapy.

(Press release, Onchilles Pharma, NOV 7, 2025, View Source [SID1234659656])

On November 7, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported that the Company is presenting evidence of strong immune system engagement and anti-cancer activity of its next generation Bria-OTS+ platform in preclinical models at a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40 th Anniversary Annual Meeting, to be held November 7-9, 2025, in National Harbor, MD.

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Title: Redefining Cancer Vaccines: Bria-OTS+ Integrates Trained Innate Immunity and Adaptive Memory to Overcome Immune Resistance
Abstract Number: 353
Location: Prince George ABC Exhibit Halls, Gaylord National Resort and Convention Center
Date: Friday, November. 7, 2025
Time : 12:15-1:45 PM, and 5:35-7 PM ET

"We are thrilled with the comprehensive, powerful, and long-lasting immune activation demonstrated by Bria-OTS+ in our preclinical studies, which we believe will translate into meaningful anti-cancer immune responses in the clinic," stated Miguel A. Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer. "By training both the innate and adaptive arms of the immune system, Bria-OTS+ represents an important step toward developing more durable and broadly effective cancer immunotherapies."

"These findings add to the growing body of evidence supporting our Bria-OTS+ platform’s unique mechanism of action for novel personalized cancer immunotherapies. We look forward to confirming these encouraging preclinical results in planned clinical trials of Bria-BRES+ for breast cancer and Bria-PROS+ for prostate cancer," commented Dr. William V. Williams, BriaCell’s President and CEO.

Summary of Preclinical Findings

Bria-OTS+ Fast Acting and Potent Anti-Cancer Immune System Activation :
Bria-BRES+ and Bria-PROS+ rapidly activated key components of the immune system in preclinical models. The platform induced coordinated innate and adaptive immune responses, training the immune system to kill cancer cells. These findings are consistent with strong anti-tumor immune activity and support its promise as BriaCell’s next generation cancer immunotherapy platform.

Bria-OTS+ Long Lasting Anti-Cancer Response :
Both Bria-BRES+ and Bria-PROS+ produced sustained, and durable anti-cancer immune responses that may translate into prolonged clinical benefit for patients treated with the Bria-OTS+ platform of whole cell immunotherapies.

Bria-OTS+: Broad Applicability :
Positive results with lead candidates Bria-BRES+ and Bria-PROS+ reinforce the broad applicability of the Bria-OTS+ platform and support possible expansion into other solid tumor indications. These data highlight the platform’s capacity to generate broad and potent immune responses against multiple tumor types that share key immune-recognition features.

(Press release, BriaCell Therapeutics, NOV 7, 2025, View Source [SID1234660840])

On November 7, 2025 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended September 30, 2025.

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"We remain focused on multiple upcoming milestones before year-end, including top-line results from our Phase 2a clinical trial in mild-to-moderate psoriasis with SGX302 (synthetic hypericin) and an enrollment update for the confirmatory Phase 3 study evaluating HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL)," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Recently, we were pleased to announce that the first Data Monitoring Committee (DMC) meeting for the confirmatory Phase 3 study evaluating HyBryte in the treatment of CTCL had concluded that there were no safety concerns, with HyBryte demonstrating an acceptable safety profile that remains consistent with the safety data from all prior clinical studies. Looking ahead to 2026, Phase 3 enrollment remains on track with top-line results anticipated in the second half of 2026."

Dr. Schaber continued, "With approximately $10.5 million in cash at September 30, 2025, we’re focused on carefully allocating resources to hit our strategic goals and upcoming milestones. While this cash balance provides sufficient operating runway through 2026, we continue to evaluate all strategic options, including partnership, merger and acquisition, government grants, and potential financing opportunities to advance our late-stage pipeline and the Company."

Soligenix Recent Accomplishments

On October 14, 2025, the Company announced the update of its United States (U.S.) Medical Advisory Board (MAB) for CTCL to provide medical/clinical strategic guidance to the Company as it advances the Phase 3 clinical development of HyBryte. To view this press release, please click here.
On October 7, 2025, the Company announced its first DMC meeting for its confirmatory Phase 3 study evaluating HyBryte in the treatment of CTCL had concluded that there were no safety concerns and that HyBryte has an acceptable safety profile that remains consistent with the safety data from all prior clinical studies. To view this press release, please click here.
On September 30, 2025, the Company announced the expansion of its European MAB to provide additional medical/clinical strategic guidance to the Company as it advances its confirmatory Phase 3 d study evaluating the safety and efficacy of HyBryte. To view this press release, please click here.
On September 29, 2025, the Company announced the closing of its previously announced public offering with participation from existing and certain healthcare focused institutional investors. To view this press release, please click here.
On September 23, 2025, the Company announced the appointment of Tomas J. Philipson, PhD as a Strategic Advisor, given his extensive experience and relationships at the highest levels of government, including with U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services. To view this press release, please click here.
On September 4, 2025, the Company announced a publication describing the extended stability of ebolavirus vaccines using its ThermoVax platform. To view this press release, please click here.
On August 18, 2025, the Company announced that the Office of Orphan Products Development of the FDA had granted orphan drug designation to dusquetide, the active ingredient in SGX945, for "treatment of Behçet’s Disease" following review of positive Phase 2a clinical results demonstrating biological efficacy and safety in patients with Behçet’s Disease. To view this press release, please click here.
Financial Results – Quarter Ended September 30, 2025

Soligenix reported no revenue for the quarters ended September 30, 2025 and 2024.

Soligenix’s net loss was $2.5 million, or ($0.58) per share, for the quarter ended September 30, 2025, compared to $1.7 million, or ($0.78) per share, for the quarter ended September 30, 2024. This increase in net loss was primarily due to an increase in operating expenses related to ongoing clinical trials and a decrease in interest income and a CARES Act employee retention credit received during the three months ended September 30, 2024 with no corresponding employee retention credit received during the three months ended September 30, 2025.

Research and development expenses were $1.6 million for the quarter ended September 30, 2025 as compared to $1.0 million for the same period in 2024. The increase was primarily due to costs associated with the second confirmatory Phase 3 CTCL trial as well as increases in third party contract manufacturing.

General and administrative expenses were $1.0 million for the quarter ended September 30, 2025 as compared to $0.9 million for the same period in 2024. The decrease was primarily attributable to increases in professional expenses.

As of September 30, 2025, the Company’s cash position was approximately $10.5 million.

(Press release, Soligenix, NOV 7, 2025, View Source [SID1234659641])

On November 7, 2025 A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage cell therapy company developing first-in-class logic-gated cell therapies for solid tumors, reported the presentation of safety and early efficacy data from the EVEREST-2 study (NCT06051695) of its lead program, A2B694. The data was presented at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) and was recognized as a Top 150 Abstract.

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The findings from EVEREST-2 include the first reported complete response (CR) in a patient with non-small cell lung cancer (NSCLC) following treatment with a CAR T-cell therapy. This patient had progressive, metastatic NSCLC with KRAS G12V/STK11 co-mutations, an aggressive subtype associated with resistance to chemoimmunotherapy and poor prognosis. The patient had also been refractory to first-line therapy. After a single infusion of A2B694, the patient achieved a CR (per RECIST 1.1) at day 90 that was confirmed by central review at day 180. Complete responses have rarely been observed in studies of CAR T-cell therapies for the treatment of solid tumors and none have been reported in patients with lung cancer.1

"It is exciting to share the first report of a complete response to CAR T-cell therapy in a patient with a hard-to-treat case of non-small cell lung cancer. Our findings from the ongoing EVEREST-2 study demonstrate that A2B694 holds promise as a new precision cell therapy targeting mesothelin-expressing solid tumors, such as NSCLC, mesothelioma, pancreatic, ovarian, and colorectal cancer, if future studies prove successful," said Salman R. Punekar, M.D., assistant professor of medicine, NYU Langone Health, Perlmutter Cancer Center and treating physician of this patient.

Evaluating A2B694

As of September 11, 2025, nine patients were enrolled in EVEREST-2, including three patients with ovarian cancer; two patients with pancreatic cancer; and one patient each with NSCLC, colorectal cancer, gastro-esophageal cancer, and mesothelioma. Three dose levels were administered: 1×10⁸ (n=3), 2×10⁸ (n=4), and 4×10⁸ (n=2) cells, of which one patient each at the 1×10⁸ and 2×10⁸ levels received half dose due to body weight, per clinical protocol. Maximum tolerated dose (MTD) has not been reached. Higher doses up to 14×10⁸ are planned to be evaluated in this dose-finding trial.

A2B694 Safety

A2B694 had manageable safety and was well tolerated with no dose-limiting toxicities. Lymphodepletion prior to A2B694 administration was well tolerated, with typical, transient cytopenias. There were no dose-limiting toxicities (DLTs) or cases of cytokine release syndrome (CRS). There was one case of grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS), which was successfully managed. No deaths were attributed to A2B694, and no patient has discontinued the study due to adverse events.

A2B694 Pharmacokinetics

A2B694 was detected post-infusion in peripheral blood and showed cell expansion in all treated patients, and was also detected in multiple tumor biopsies. In one patient, A2B694 was detected in a tumor biopsy collected on day 42, but not in the concurrently collected blood sample, demonstrating that A2B694 can infiltrate the tumor microenvironment and persist for weeks, even when undetectable in the peripheral blood.

Case Report of Complete Response in NSCLC patient

A patient with co-mutated (KRAS G12V/STK11) NSCLC, a subtype associated with resistance to chemoimmunotherapy and poor prognosis, had progressed on standard-of-care first-line treatment of carboplatin, pemetrexed, and pembrolizumab before enrolling in EVEREST-2. At day 90 post-infusion of A2B694, the patient achieved a complete response (CR) per RECIST 1.1 and had a confirmed CR by central review at day 180. PET-CT scan on day 190 showed no evidence of disease. Longitudinal ctDNA tests that detected tumor mutations at diagnosis showed no detections of those same mutations post-treatment at month 6 and again at month 8. On day 243, the patient had an isolated CNS relapse, with an ongoing non-CNS CR per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM). The patient was treated with dexamethasone and definitive gamma knife radiosurgery. Subsequent PET-CT demonstrated continued absence of disease on day 284. At month 12, the patient’s CT showed no new findings.

Poster Presentation Details

Title:

EVEREST-2: A phase 1/2 study of A2B694, a logic‑gated Tmod CAR T therapy to treat solid tumors expressing mesothelin (MSLN) with HLA-A*02 loss of heterozygosity: initial safety and efficacy results

Presenter:

Jeffrey Ward, M.D., Ph.D.

Assistant Professor of Medicine, Division of Oncology

Washington University School of Medicine

Date:

Friday, November 7, 2025

Location:

Prince George ABC Halls, Lower-Level Atrium

Gaylord National Resort and Convention Center

Poster No.:

535

Enabling Efficient Patient Identification for Precision Medicine Studies

The BASECAMP-1 (NCT04981119) master prescreening study enables efficient identification of patients for all A2 Bio precision medicine studies. Patients are enrolled in EVEREST-2 through BASECAMP-1, which identifies patients with HLA loss of heterozygosity (LOH) at any time in the course of their disease via next-generation sequencing. Upon disease progression, the participant may screen for enrollment in EVEREST-2. There is no time requirement between the studies, and patients may go directly from BASECAMP-1 to EVEREST-2 based on their own disease course. BASECAMP-1 utilizes artificial intelligence (AI)-enabled precision diagnostics as a cost-effective, high-yield approach to identify eligible patients for all A2 Bio clinical studies.2,3

A2 Bio continues to advance its clinical development of A2B694, A2B395, the BASECAMP-1 prescreening study, and other preclinical programs as the company pursues additional pipeline expansion opportunities using its proprietary Tmod technology platform. The TmodTM platform comprises a suite of technologies that can be used in isolation or in combination, and in both autologous and allogeneic settings, to create novel therapies for cancers and beyond.

For more information about A2 Bio clinical studies and how to enroll, visit www.a2bioclinicaltrials.com

All of A2 Bio’s scientific posters and publications are available at www.a2bio.com/science/abstracts-and-publications/

About EVEREST-2

EVEREST-2 (NCT06051695) is a seamless Phase 1/2 study evaluating the safety and efficacy of A2B694, an autologous logic-gated investigational cell therapy developed from the A2 Bio proprietary Tmod platform. The Tmod platform provides selective killing of tumor cells and protection of normal cells via a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. A2B694 consists of an activator that targets mesothelin (MSLN) and a blocker that targets HLA-A*02. HLA-A*02 is lost in tumor cells and present in normal cells in the eligible patient population. The study is recruiting participants with colorectal cancer, pancreatic cancer, non-small cell lung cancer, ovarian cancer, mesothelioma, and other solid tumors that express MSLN and have lost HLA-A*02 expression.

About the Tmod Platform

A2 Bio has pioneered a precision-targeting cellular system – the Tmod platform – that incorporates two receptors, an activator and a blocker, to aim the powerful armaments of immune cells directly at tumors to unequivocally differentiate tumors from normal tissues. The activator recognizes antigens on tumor cells that trigger their destruction, while the blocker recognizes antigens on normal cells that protect them. This novel blocker technology enables precise, personalized and effective T-cell targeting. The blocker component equips Tmod cells with the capacity to identify tumors as distinct from normal cells.

(Press release, A2 Biotherapeutics, NOV 7, 2025, View Source [SID1234659657])

On November 6, 2025 Lisata Therapeutics, Inc. (Nasdaq: LSTA) ("Lisata" or the "Company"), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, reported a business update and announced financial results for the third quarter ended September 30, 2025.

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"Once again, the recent quarter saw the reporting of positive data from a number of clinical studies involving certepetide, including from the ASCEND, iLSTA, and CENDIFOX trials. Importantly, we also announced a strategic alliance with GATC Health to use their Multiomics Advanced Technology artificial intelligence drug discovery platform to identify product candidates for development, as well as a global license agreement in which Catalent gained access to certepetide for use across various Antibody-Drug Conjugates. Overall, it was a productive and positive quarter marked by our continued vigilance in managing expenses. As a result, we now project that our available cash will fund current operations into the first quarter of 2027," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata. "We anticipate a steady flow of additional data through the remainder of 2025 and into 2026."
Development Portfolio Highlights

Certepetide as a treatment for solid tumors in combination with other anti-cancer agents

Certepetide (formerly LSTA1), a proprietary, internalizing RGD (arginyl-glycyl-aspartic acid or iRGD), cyclic peptide product candidate, is an investigational drug designed to activate the C-end rule active transport mechanism in a tumor specific manner, resulting in systemically co-administered anti-cancer agents more efficiently penetrating and accumulating in the tumor. Additionally, certepetide has been shown to modify the tumor microenvironment ("TME"), diminishing its immunosuppressive nature, enhancing cytotoxic T cell concentration in the TME and inhibiting the metastatic cascade. Lisata and its collaborators have amassed significant clinical and non-clinical data demonstrating enhanced efficacy and acceptable safety of various existing and emerging anti-cancer therapies, including chemotherapies, immunotherapies, RNA-based therapeutics, and Antibody-Drug Conjugates ("ADCs") in solid tumor models.

Certepetide has been awarded Fast Track designation (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.) as well as Orphan Drug Designation for glioma, osteosarcoma, and cholangiocarcinoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.). Currently, certepetide is the subject of multiple ongoing and proposed (subject to sufficient funding) global clinical studies across several solid tumor types in combination with a variety of anti-cancer regimens, including:

•ASCEND: Phase 2b double-blind, randomized (2:1 ratio), placebo-controlled trial evaluating two dosing regimens of certepetide in combination with standard-of-care ("SoC") chemotherapy (gemcitabine/nab-paclitaxel) in patients with previously untreated metastatic pancreatic ductal adenocarcinoma ("mPDAC"). The trial was conducted across 25 sites in Australia and New Zealand led by the Australasian Gastro-Intestinal Trials Group ("AGITG") and coordinated by the National Health and Medical Research Council Clinical Trial Centre at the University of Sydney. Cohort A, with 95 patients receiving a single intravenous ("IV") dose of certepetide 3.2 mg/kg or placebo in combination with SoC, completed enrollment in the third quarter of 2023. Preliminary Cohort A data presented at the 2025 ASCO (Free ASCO Whitepaper)-GI Symposium showed a positive trend in overall survival, including four complete responses in the certepetide-treated group compared to none in the placebo treated group. Preliminary data from Cohort B, with 63 patients receiving two IV doses of certepetide 3.2 mg/kg or placebo administered 4 hours apart in combination with SoC, was presented at the ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers ("ESMO-GI") Congress on July 2, 2025. The preliminary Cohort B data demonstrate a positive signal in progression-free survival and objective response rate observed in the certepetide-treated group compared to the placebo-treated group, indicating that the addition of two doses of certepetide (Cohort B regimen) to SoC resulted in a clinically meaningful treatment effect and an attractive safety profile. Additionally, pooled data from both Cohorts A and B, which was presented at the ESMO (Free ESMO Whitepaper) Congress in October 2025, further corroborated previous findings and indicated no increase in adverse events in the certepetide-treated groups beyond those experienced in the SoC alone groups. Final data and key findings from both cohorts of the ASCEND study are anticipated for the first quarter of next year.
•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 fourth quarter of 2025. Based on investigator enthusiasm, a second cohort was added, evaluating certepetide in combination with SoC in subjects with second-line CCA. In September 2024, Lisata announced the first patient treated in the second-line CCA cohort and more recently, completed enrollment at approximately 20 patients to accelerate data read out and optimize capital allocation.

•CENDIFOX: Investigator-initiated 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. In December 2024, the Company announced enrollment completion in all three cohorts. The single-center study, conducted solely at the University of Kansas Cancer Center, was designed with a 3-cycle run-in period to ensure patients met specific criteria before receiving treatment. Of the 66 patients enrolled, 50 patients met the criteria and were treated with certepetide across three cohorts, including 24 with resectable or borderline resectable pancreatic ductal adenocarcinoma ("PDAC"), 15 with high-grade colon or appendiceal cancer and peritoneal metastasis, and 11 with oligometastatic colon cancer. The trial is expected to provide Lisata with valuable pre- and post-treatment tumor tissue data for immune profiling, along with long-term patient outcome information. Preliminary data from the PDAC cohort, presented at the AACR (Free AACR Whitepaper) Special Conference in September 2025, showed that the combination of certepetide with FOLFIRINOX was safe and feasible. In the 10 patients who completed the therapy and underwent surgery, treatment resulted in a 50% R0 resection rate and a 70% pathologic partial response, alongside promising early survival data, including a 60% two-year overall survival rate. Importantly, the combination therapy appears to transform tumors from "immune-cold" to "immune-hot" by enhancing immune cell infiltration and increasing markers like PD-1 and PD-L1, which could significantly improve the efficacy of subsequent immunotherapies. Additional CENDIFOX data are expected in the coming months under the auspices of the investigator. The trial is funded by the University of Kansas Cancer Center and Lisata is supplying certepetide.

•Qilu Pharmaceutical, the licensee of certepetide in the Greater China territory, is developing certepetide in combination with gemcitabine and nab-paclitaxel as a treatment for first-line mPDAC. During the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting, Qilu Pharmaceutical presented an abstract sharing preliminary data from the study which corroborated previously reported findings from the Phase 1b/2a trial of certepetide plus gemcitabine and nab-paclitaxel conducted in Australia in patients with first-line mPDAC. Qilu has completed enrollment in its Phase 2 trial and data are expected in 2026.

•iLSTA: Phase 1b/2a randomized, single-blind, single-center, safety and pharmacodynamic trial in Australia, funded by WARPNINE Inc., a non-profit foundation, 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. Study enrollment is complete and results from an interim analysis were presented at the ESMO (Free ESMO Whitepaper)-GI Congress on July 3, 2025, showing compelling new corroborative data for certepetide. Consistent with the earlier findings presented at the 2025 ASCO (Free ASCO Whitepaper)-GI meeting, the data demonstrate certepetide’s potential to enhance immunotherapy effectiveness by provoking significant RECIST responses and improving overall response and disease control rates. Final data from this study are anticipated in the first quarter of 2026.
•GBM: A Lisata-funded Phase 2a, double-blind, placebo-controlled, randomized, proof-of-concept study evaluating certepetide in combination with SoC temozolomide versus SOC 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 is progressing according to plan and completion is expected in 2026.
Notable business development achievements in the third quarter:
•Lisata and Catalent entered into a nonexclusive license agreement that grants Catalent global rights to evaluate certepetide and its analogs for use as SMARTag payloads across multiple ADCs designed to address difficult-to-treat diseases. As presented at the World ADC conference earlier this week, compelling positive data from Catalent’s preclinical study evaluating certepetide and its analogs as non-cytotoxic SMARTag ADC payloads showed not only improved ADC efficacy but broadened distribution of the cytotoxic payload within the tumor, supporting certepetide’s potential to enhance the targeting, penetration, and effectiveness of ADCs in advanced solid tumors.
•Lisata entered into a strategic alliance with GATC Health to exploit GATC’s AI-powered Multiomics Advanced Technology artificial intelligence drug discovery platform to optimize and accelerate drug discovery and development, including analyzing certepetide for new indications and identifying combination therapies.
Third Quarter 2025 Financial Highlights
Operating Expenses
For the three months ended September 30, 2025, operating expenses totaled $4.4 million, compared to $5.3 million for the three months ended September 30, 2024, representing a decrease of $0.9 million or 17.3%.
Research and development expenses were approximately $2.0 million for the three months ended September 30, 2025, compared to $2.5 million for the three months ended September 30, 2024, representing a decrease of $0.6 million or 22.9%. This was primarily due to lower spend on chemistry, manufacturing and controls and a reduction in Clinical department expenses partially offset by an increase in the BOLSTER trial costs.
General and administrative expenses were approximately $2.5 million for the three months ended September 30, 2025, compared to $2.8 million for the three months ended September 30, 2024, representing a decrease of $0.3 million or 12.1%. This was primarily due to lower spend on consulting and the elimination of an employee position.
Overall, net losses were $4.2 million for the three months ended September 30, 2025, compared to $4.9 million for the three months ended September 30, 2024.
Balance Sheet Highlights
As of September 30, 2025, we had cash and cash equivalents of approximately $19.0 million. Based on its existing and planned activities, the Company believes available funds will support current operations into the first quarter of 2027.

Conference Call Information
Lisata will hold a live conference call today, November 6, 2025, at 4:30 p.m. Eastern Time to discuss financial results, provide a business update and answer questions. To join the conference call, please refer to the dial-in information provided below:
Dial-in information:
Participant Toll-Free dial: (800) 715-9871
Participant Toll/Int’l dial: (646) 307-1963
Conference ID: 6375221

To avoid delays, we encourage participants to dial into the conference call 10 minutes ahead of the scheduled start time.
A live webcast of the call will also be accessible under the Investors & News section of Lisata’s website and will be available for replay beginning two hours after the conclusion of the call for 12 months.

(Press release, Lisata Therapeutics, NOV 6, 2025, View Source [SID1234659557])