On August 7, 2025 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported financial results for the second quarter ended June 30, 2025, as well as business updates (Press release, C4 Therapeutics, AUG 7, 2025, View Source [SID1234654964]).

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"The first half of 2025 was driven by focused execution across our business with the achievement of several research milestones with our collaborators and within our internal preclinical pipeline, the advancement of cemsidomide toward label-enabling trials and continued financial discipline that resulted in extending cash runway. We recently completed enrollment in the ongoing cemsidomide Phase 1 trials in multiple myeloma and non-Hodgkin’s lymphoma and look forward to sharing the full Phase 1 multiple myeloma data in September, which we believe further demonstrate cemsidomide’s best-in-class potential. Our recent Type C meeting with the FDA enabled refinement of our cemsidomide registrational development plans and we remain on track to initiate registrational development in early 2026," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "Additionally, as part of C4T’s commitment to strategic capital allocation and despite cemsidomide’s compelling response rates observed in non-Hodgkin’s lymphoma, we are prioritizing cemsidomide multiple myeloma registrational development as we believe this has the highest potential for patient impact and value creation."

SECOND QUARTER 2025 HIGHLIGHTS AND RECENT ACHIEVEMENTS

Cemsidomide:

Completed enrollment and dose escalation for the Phase 1 trial of cemsidomide in multiple myeloma (MM) and non-Hodgkin’s Lymphoma (NHL). Cemsidomide continued to demonstrate a well-tolerated profile and compelling response rates in MM and NHL. The highest dose level studied in both indications was 100 µg once daily (QD).

Data from the cemsidomide Phase 1 trial in MM was accepted as an oral presentation at the International Myeloma Society (IMS) Annual Meeting taking place from September 17 – September 20, 2025 in Toronto, Canada. The presentation will include data from all safety and efficacy evaluable MM patients from all dose levels studied.

C4T had a productive Type C meeting with the U.S. Food and Drug Administration (FDA) that enabled further refinement of the cemsidomide registrational development plan. By year-end 2025, C4T expects to align with the FDA on a recommended Phase 2 dose based on the existing Phase 1 MM data.

Additionally, C4T is on track to initiate registrational development in early 2026. The next phase of development will evaluate cemsidomide in combination with dexamethasone in the late-line MM setting and in combination with a B-cell maturation antigen bispecific T-cell engager (BCMA BiTE) for earlier lines of MM treatment.
CFT8919:

Partner Betta Pharmaceuticals continues to advance the CFT8919 Phase 1 dose escalation trial in Greater China.
Research and Discovery Collaborations:

C4T advanced its collaboration with Merck KGaA, Darmstadt, Germany (MKDG), which is focused on two projects within the KRAS family, to a milestone on one of these projects. C4T earned $1 million upon achieving this milestone.

C4T has identified multiple degraders against two novel targets outside of oncology, which are now advancing into the next phase of discovery.
KEY UPCOMING MILESTONES AND DATA PRESENTATIONS

Present data from full cemsidomide Phase 1 dose escalation in MM at IMS taking place from September 17 – September 20, 2025.

Binod Dhakal, M.D., M.S., associate professor of medicine, Medical College of Wisconsin, Division of Hematology, will present an oral presentation titled "Updated Results of a Phase 1 First-in-Human Study of Cemsidomide (CFT7455), a Novel MonoDAC Degrader, with Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma."

Management will host an investor call to discuss cemsidomide data in MM in conjunction with the IMS presentation.

Present data from cemsidomide Phase 1 dose escalation in NHL in Q4 2025.

Enable initiation of the next phase of cemsidomide clinical development in MM with new studies expected to initiate in early 2026.

Present poster analyzing cemsidomide clinical data of population pharmacokinetic and exposure-response relationships in MM and NHL at the 2025 American Conference on Pharmacometrics (ACoP 2025) on October 20, 2025.

SECOND QUARTER 2025 FINANCIAL RESULTS

Revenue: Total revenue for the second quarter of 2025 was $6.5 million, compared to $12.0 million for the second quarter of 2024. The decrease in revenue was primarily due to an $8.0 million milestone that was earned from Biogen in the second quarter of 2024 partially offset by achievement of a preclinical milestone under our MKDG collaboration and continued progress on our other collaboration programs.

Research and Development (R&D) Expense: R&D expense for the second quarter of 2025 was $26.2 million compared to $23.8 million for the second quarter of 2024. The increase in R&D expense was primarily related to clinical trial expenses for cemsidomide, in addition to increased preclinical spend as the company’s research collaborations continue to advance.

General and Administrative (G&A) Expense: G&A expense for the second quarter of 2025 was $8.8 million compared to $9.7 million for the second quarter of 2024. The decrease was primarily related to lower stock-based compensation expense.

Net Loss and Net Loss per Share: Net loss for the second quarter of 2025 was $26.0 million, compared to $17.7 million for the second quarter of 2024. Net loss per share for the second quarter of 2025 was $0.37 compared to $0.26 for the second quarter of 2024.

Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of June 30, 2025 were $223.0 million, compared to $234.7 million as of March 31, 2025 and $267.3 million as of December 31, 2024. The decrease during the second quarter was primarily the result of cash used to fund operations and advance our programs, partially offset by cash received for milestones under our Roche and MKDG collaborations. The company expects that its cash, cash equivalents and marketable securities as of June 30, 2025 will enable the company to fund its operating plan to mid-2027.

On August 7, 2025 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported its financial results for the second quarter ended June 30, 2025, and provided a business update (Press release, Immunocore, AUG 7, 2025, View Source [SID1234654980]).

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"We are delighted to announce robust revenue for the first half of 2025, a 32% year-over-year increase. This is testament to our steadfast dedication to expanding access to KIMMTRAK in the US and across the globe," said Bahija Jallal, Chief Executive Officer of Immunocore. "Our Phase 3 TEBE-AM trial remains on schedule to complete enrollment in the first half of 2026, and we are making good progress with our other two Phase 3 trials: PRISM-MEL-301 and ATOM. We are also advancing our Phase 1/2 trials in oncology and infectious diseases and preparing for the clinical trial applications for our autoimmune candidates, further underscoring the depth and diversity of our platform."

Second Quarter 2025 Highlights (including post-period)

KIMMTRAK
The Company’s lead product, KIMMTRAK (tebentafusp), is approved in 39 countries and has been launched in 28 countries globally to date for HLA-A*02:01 positive people with metastatic uveal melanoma (mUM). KIMMTRAK continues to be the standard of care in most markets where it is launched.

The Company sees three key growth areas as it plans to expand patient reach for KIMMTRAK, including continued global expansion in mUM, the potential expansion into 2L+ advanced cutaneous melanoma (CM), and the potential expansion into adjuvant uveal melanoma.

Metastatic uveal melanoma

KIMMTRAK net product sales were $98.0 million and $191.8 million for the three and six months ended June 30, 2025, respectively, representing increases of 30% and 32% respectively, as compared to the same periods in 2024.
15% year-over-year quarterly growth in the United States, with demand continuing to grow, duration of treatment extending, and the majority of patients treated in the community setting (70%).
71% year-over-year quarterly growth in Europe and in international regions combined, driven by increased demand, new country launches, and completion of price negotiations in France and Germany.
The Company signed a distribution and commercialization agreement with Er-Kim Pharmaceuticals for KIMMTRAK, for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma, in Turkey, the Middle East, North Africa, Caucasus and the Commonwealth of Independent States regions.
2L+ advanced cutaneous melanoma

The Company is currently enrolling patients in the TEBE-AM registrational Phase 3 trial and expects to complete enrollment in the first half of 2026.
The Phase 3 trial is enrolling three arms: tebentafusp monotherapy, tebentafusp in combination with pembrolizumab, and a control (investigator’s choice of therapy including options such as investigator’s choice of clinical trials, chemotherapy, or retreatment with anti-PD1 or BRAF therapy). The primary endpoint of the randomized Phase 3 trial is Overall Survival (OS).
There is great unmet need in second- and later-line cutaneous melanoma, with no therapy having shown an OS improvement post checkpoint inhibitors in a randomized clinical trial. The Company estimates that there is a potential to address up to 4,000 previously treated advanced CM patients.

Adjuvant uveal (or ocular) melanoma

The European Organisation for Research and Treatment of Cancer (EORTC) continues to expand the site footprint of the Phase 3 Adjuvant Trial in Ocular Melanoma (ATOM).
The Company estimates that the HLA-A*02:01 high-risk adjuvant uveal melanoma patient population could be up to 1,200 patients in the US and Europe.

PRAME portfolio
Brenetafusp is the Company’s lead PRAME-A02 ImmTAC bispecific candidate. Brenetafusp is being evaluated in combination with nivolumab in a Phase 3 registrational trial (PRISM-MEL-301) in patients with first-line, advanced cutaneous melanoma, and in a Phase 1/2 clinical trial as monotherapy and in combination across multiple tumor types, including ovarian cancer and non-small cell lung cancer (NSCLC).

PRISM-MEL-301 – First PRAME Phase 3 clinical trial with brenetafusp in first-line advanced cutaneous melanoma

The Company has now activated over 150 clinical trial sites around the world, enrolling patients in the registrational Phase 3 clinical trial evaluating brenetafusp + nivolumab versus a control arm of either nivolumab or nivolumab + relatlimab for HLA-A*02:01 positive patients with first-line, advanced or metastatic cutaneous melanoma.
The trial is currently randomizing to three arms: two brenetafusp dose regimens (40 mcg and 160 mcg) and a control arm.
In a pre-planned analysis, the Independent Data Monitoring Committee (IDMC) reviewed the safety of the first 30 patients randomized and recommended to continue the study with no changes. The trial is on track for selection of the go-forward brenetafusp dose in the second half of 2025; this analysis will be conducted by an IDMC.
Despite approved therapies, there remains a need for improved progression-free survival and overall survival, and there is the potential to address an estimated 10,000 HLA-A*02:01 positive patients in the US and Europe.
Phase 1/2 clinical trial of brenetafusp in multiple solid tumors

The Company continues to evaluate brenetafusp in a Phase 1/2 trial in combination with non-platinum chemotherapies in platinum-resistant ovarian cancer (PROC) and with bevacizumab or with platinum chemotherapy in earlier lines of platinum-sensitive ovarian cancer (PSOC). In the same trial, the Company continues signal detection in metastatic non-small cell lung cancer (NSCLC) cohorts, including brenetafusp in combination with docetaxel and with osimertinib in earlier-line NSCLC.
The Company estimates that, across all solid tumors, the annual number of eligible patients worldwide who test positive for HLA-A*02:01 is up to 150,000.
IMC-P115C (PRAME-A02 Half-Life Extended) & IMC-T119C (PRAME-A24)

The Company is enrolling patients in the Phase 1 dose escalation trial, in multiple solid tumors, with IMC-P115C.

IMC-R117C (PIWIL1) for colorectal and other gastrointestinal cancers

The Company is enrolling patients in the Phase 1/2 dose escalation trial evaluating IMC-R117C in HLA-A*02:01 positive patients with advanced solid tumors, including colorectal cancer, as a single agent and in combination with standards of care.

ImmTAV candidates for a functional cure in infectious diseases
The Company’s bispecific TCR technology platform has the potential to offer a new approach for the treatment of certain chronic infections and aims to eliminate evidence of remaining virus in circulation after the patient stops taking medication – known as a ‘functional cure’. Two investigational candidates are in Phase 1 or Phase 1/2 trials for people living with human immunodeficiency virus (HIV) and people with chronic hepatitis B infection (HBV).

Phase 1/2 trial of IMC-M113V (Gag-A02) for people living with HIV

Patient enrollment continues at higher doses in the multiple ascending dose part of the Phase 1/2 clinical trial to identify a safe and tolerable dose.

Phase 1 trial of IMC-I109V (Envelope-A02) for people living with HBV or HBV-positive hepatocellular carcinoma

The Company will report data from the single ascending dose portion of the trial at the 2025 American Association for the Study of Liver Diseases’ Meeting in November 2025.

Tissue-specific down modulation of the immune system for autoimmune diseases
The key differentiator of the ImmTAAI platform is tissue-specific, down modulation of the immune system, as the candidates suppress pathogenic T cells via PD1 receptor agonism only when tethered to the target tissue.

IMC-S118AI (PPI-A02) for type 1 diabetes

The Company is on track to file a clinical trial application (CTA) or investigational new drug application (IND) for IMC-S118AI (PPI x PD1) in the second half of 2025.

IMC-U120AI (CD1a) for atopic dermatitis as the initial indication – first universal program

The Company plans to file a CTA/IND for IMC-U120AI (CD1a x PD1) in 2026.

Corporate update
On August 5, 2025, Rob Perez resigned as director of the Company, effective September 16, 2025. The Company expresses its appreciation to Mr. Perez for his dedication and service to Immunocore for the last 6 years.

Financial Results
For the second quarter ended June 30, 2025, the Company generated net product sales of $98.0 million compared to $75.3 million for the same period in 2024. Sales of KIMMTRAK were $64.1 million in the United States, $33.0 million in Europe, and $0.8 million in the international regions. The increase in net product sales was due to increased volumes in the United States and Europe as well as global country expansion.

For the quarter ended June 30, 2025, research and development (R&D) expenses were $69.0 million compared to $51.1 million for the same period in 2024. The increase was due to preclinical expenses related to the advancement of the Company’s autoimmune programs, including clinical material manufacturing for anticipated Phase 1 initiations, and clinical expenses related to the progression of the Company’s Phase 3 trials, primarily TEBE-AM and PRISM-MEL-301.

For the quarter ended June 30, 2025, SG&A expenses were $42.8 million compared to $38.6 million for the same period in 2024. The increase was primarily due to costs related to business support functions to support the Company’s growing pipeline and global commercial expansion.

Net loss for the quarter ended June 30, 2025, was $10.3 million, as compared to a net loss of $11.6 million for the same period in 2024. Basic and diluted loss per share was $0.20 for the quarter ended June 30, 2025, as compared to a basic and diluted loss per share of $0.23 for the same period in 2024.

Cash, cash equivalents and marketable securities were $882.8 million as of June 30, 2025, as compared to $820.4 million as of December 31, 2024. The Company expects to pay, in the second half of 2025, approximately $65 million in sales-related rebate accruals.

On August 7, 2025 RAPT Therapeutics, Inc. (Nasdaq: RAPT) ("RAPT" or the "Company"), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases, reported financial results for the second quarter and six months ended June 30, 2025 (Press release, RAPT Therapeutics, AUG 7, 2025, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-reports-second-quarter-2025-financial-results [SID1234654996]).

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"The first half of 2025 has been productive, with several key achievements setting the stage for important catalysts anticipated in the second half of the year," said Brian Wong, President and CEO of RAPT. "We strengthened our team with the addition of Jessica Savage, an experienced drug developer in the food allergy space, and our board of directors with the appointments of industry veterans Drs. Scott Braunstein and Ashley Dombkowski. We have been focused on execution and as we enter the second half of the year we remain on track to initiate our Phase 2b trial of RPT904 in food allergy later this year. We also remain on track with our partner, Jemincare, to report topline results from Jemincare’s Phase 2 trials of RPT904 in CSU and asthma in the second half of this year. Lastly, we continue to advance our next-generation CCR4 pipeline and we see the diversity of our pipeline as a differentiating strength."

Financial Results for the Second Quarter and Six Months Ended June 30, 2025

Please note: All share amounts and per share amounts in this press release have been adjusted to reflect the 1-for-8 reverse split of the Company’s common stock, effected on June 16, 2025.

Second Quarter Ended June 30, 2025

Net loss for the second quarter of 2025 was $17.6 million, compared to $27.7 million for the second quarter of 2024.

Research and development expenses for the second quarter of 2025 were $12.3 million, compared to $22.6 million for the second quarter of 2024. The decrease in research and development expenses was primarily due to decreases in costs related to development of zelnecirnon and tivumecirnon, personnel, lab supplies, non-cash stock-based compensation and facilities, partially offset by increases in costs related to development of RPT904 and early-stage programs.

General and administrative expenses for the second quarter of 2025 were $7.2 million, compared to $6.7 million for the same period in 2024. The increase in general and administrative expenses was primarily due to increases in consulting costs and facilities costs.

Six Months Ended June 30, 2025

Net loss for the six months ended June 30, 2025 was $34.8 million, compared to $58.2 million for the second quarter of 2024.

Research and development expenses for the six months ended June 30, 2025 were $24.4 million, compared to $47.4 million for the same period in 2024. The decrease in research and development expenses was primarily due to decreases in costs related to development of zelnecirnon and tivumecirnon, personnel, lab supplies, non-cash stock-based compensation and facilities, partially offset by increases in costs related to development of RPT904 and early-stage programs.

General and administrative expenses for each of the six months ended June 30, 2025 and 2024 were $14.4 million. General and administrative expenses were flat primarily due to decreased costs for personnel offset by increases in facilities costs.

As of June 30, 2025, the Company had cash and cash equivalents and marketable securities of $168.9 million.

On August 7, 2025 Merck KGaA reported second quarter 2025 results (Presentation, Merck KGaA, AUG 7, 2025, View Source [SID1234655046]).

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On August 7, 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 second quarter ended June 30, 2025 (Press release, Lisata Therapeutics, AUG 7, 2025, View Source [SID1234654965]).

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"We continued to advance our clinical development portfolio and partnering initiatives during the second quarter of 2025," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata. "All of our activities are to support our core mission of exploiting the broad applicability of certepetide across a variety of advanced solid tumors and other difficult-to-treat indications. To this end, we recently announced positive preliminary results from the ASCEND and iLSTA trials, and we anticipate a number of additional data events through the remainder of 2025 and into 2026."
Dr. Mazzo added, "Our continued rigorous financial management allows us to reaffirm our projection that available cash will fund current operations into the fourth quarter of 2026, including all active clinical studies through to their next data milestone."

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 non-clinical data demonstrating enhanced efficacy of various existing and emerging anti-cancer therapies, including chemotherapies, immunotherapies, and RNA-based therapeutics in solid tumor models.

In addition, to date, certepetide has also demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing clinical trials designed to demonstrate its ability to enhance the effectiveness of standard-of-care ("SoC") chemotherapy for pancreatic cancer as well as the combination of chemotherapy and immunotherapy in a variety of solid tumors. 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 or planned clinical studies being conducted globally 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 SoC chemotherapy (gemcitabine/nab-paclitaxel) in patients with previously untreated metastatic pancreatic ductal adenocarcinoma ("mPDAC"). The trial is being 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. As recently announced, 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. 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: 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 this rapid enrollment rate and the pressing need to improve treatment outcomes in patients that have progressed after first-line CCA treatment, a second cohort was added to the BOLSTER trial evaluating certepetide in combination with SoC in subjects with second-line CCA. In September 2024, Lisata announced first patient treated in the second-line CCA cohort and recently decided to stop enrollment at approximately 20 patients to accelerate data read out and optimize capital allocation.

•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. 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 cancer, 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. 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. 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 currently evaluating 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 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.

•iLSTA: Phase 1b/2a randomized, single-blind, single-center, safety and pharmacodynamic trial in Australia, funded by WARPNINE Inc., 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. As recently announced, enrollment in this study has been completed. Updated interim analyses from the iLSTA trial, presented at the ESMO (Free ESMO Whitepaper)-GI Congress on July 3, 2025, show compelling new preliminary data for certepetide. Consistent with earlier preliminary findings from the 2025 ASCO (Free ASCO Whitepaper)-GI meeting, the data reinforce certepetide’s potential to enhance immunotherapy effectiveness by provoking significant RECIST responses and improving overall response and disease control rates. 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.

Lisata entered into a research license with Catalent, Inc. ("Catalent"), to preclinically evaluate the efficacy of certepetide in combination with Catalent’s SMARTag ADC dual payload technology platform for the treatment of various difficult-to-treat diseases. Additionally, Lisata has expanded its strategic collaboration with GATC Health Corp ("GATC") to combine Lisata’s drug development expertise with GATC’s AI-powered Multiomics Advanced Technology platform to optimize and accelerate drug discovery and development, including analyzing certepetide for new indications and identifying combination therapies.

Lisata recently announced that the United States Patent and Trademark Office ("USPTO") issued the Company a new composition of matter patent for certepetide (U.S. Patent No. 12,351,653), which extends its patent protection until March 2040, with potential for further extensions. The patent grants Lisata exclusive rights to the drug itself, preventing others from manufacturing or selling certepetide. The patent’s claims cover certepetide’s chemical structure, pharmacokinetic properties, methods of manufacturing, and applications for treating solid tumors.

Second Quarter 2025 Financial Highlights

Revenue

For the three months ended June 30, 2025, revenue totaled $70 thousand in connection with an upfront license fee related to the Research License Agreement with Catalent, Inc. We did not have any revenue for the three months ended June 30, 2024.

Operating Expenses

For the three months ended June 30, 2025, operating expenses totaled $4.9 million, compared to $5.5 million for the three months ended June 30, 2024, representing a decrease of $0.6 million or 10.6%.
Research and development expenses were approximately $2.3 million for the three months ended June 30, 2025, compared to $2.6 million for the three months ended June 30, 2024, representing a decrease of $0.3 million or 13.4%. This was primarily due to a reduction in patient treatment costs and clinical research organization expenses associated with our Phase 2a BOLSTER trial and lower spend on chemistry, manufacturing and controls.
General and administrative expenses were approximately $2.7 million for the three months ended June 30, 2025, compared to $2.9 million for the three months ended June 30, 2024, representing a decrease of $0.2 million or 8.1%. This was primarily due to savings resulting from the elimination of an employee position and lower spend on consulting and travel and entertainment expenses.

Overall, net losses were $4.7 million for the three months ended June 30, 2025, compared to $5.0 million for the three months ended June 30, 2024.

Balance Sheet Highlights

As of June 30, 2025, we had cash, cash equivalents and marketable securities of approximately $22.0 million. Based on its existing and planned activities, the Company believes available funds will support current operations into the fourth quarter of 2026.

Conference Call Information
Lisata will hold a live conference call today, August 7, 2025, at 4:30 p.m. Eastern Time to discuss financial results, provide a business update and answer questions.

Those wishing to participate must register for the conference call by way of the following link: CLICK HERE TO REGISTER. Registered participants will receive an email containing conference call details with dial-in options. To avoid delays, we encourage participants to dial into the conference call 15 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.