A Phase 1b/2a, Double-blind, Placebo-controlled, Three Arm, Randomized Study Evaluating a Single Intravenous Push Followed by a Continuous Infusion of Certepetide Over 4 Hours When Added to Standard of Care (SoC) Versus Two Intravenous Pushes of Certepetide When Added to SoC, Versus SoC Alone in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (FORTIFIDE)

The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in people with metastatic pancreatic ductal adenocarcinoma.
The main questions it aims to answer are:
* is the new drug plus standard treatment safe and tolerable
* is the new drug plus standard treatment more effective than standard treatment
Participants will:
* Visit the clinic three times every 28 days for treatment and tests
* Have CT or MRI scans every 8 weeks while on treatment

Start Date01 Jan 2030

Sponsor / Collaborator

Lisata Therapeutics, Inc.

NCT07365306

/ Not yet recruitingPhase 2IIT

A Phase 2 Study of Epcoritamab-R-GemOx With Consolidative ASCT and Additional Epcoritamab in Relapsed/Refractory Transplant-Eligible DLBCL

This phase II trial tests how well epcoritamab in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) works as treatment given after the cancer has not responded to other treatments (salvage therapy) before autologous stem cell transplant in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Epcoritamab is a so-called bispecific antibody, a molecule that can bind simultaneously to two different receptors (proteins present on the cell surface). Epcoritamab binds to a receptor called CD3 with one part of the antibody and to a receptor called CD20 with another part of the antibody. CD3 is expressed on T cells, which are important cells of the immune system that help the body fight cancers and infections. CD20 is expressed on the surface of DLBCL cells. By simultaneous binding to CD3 and CD20, epcoritamab brings T cells and DLBCL cells close together and activates the T cells to kill the lymphoma cells. Rituximab is a so-called monoclonal antibody, a molecule that binds to a single receptor. Like epcoritamab, rituximab binds to CD20. After binding to CD20, rituximab activates the immune system to kill the lymphoma cell through several different mechanisms. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Giving epcoritamab-R-GemOx as therapy before an autologous stem cell transplant may help kill cancer cells in the body and help make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow.

Start Date30 Dec 2026

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT07275216

/ Not yet recruitingPhase 2IIT

Phase 2 Study of Pembrolizumab With Chemotherapy in Frail Patients With Newly Diagnosed Classical Hodgkin Lymphoma

This phase II trial tests how well pembrolizumab in addition to chemotherapy (gemcitabine, brentuximab vedotin, and dacarbazine) works in treating frail patients with newly diagnosed Hodgkin lymphoma who aren't candidates for standard anthracycline-based treatment. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. Dacarbazine is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells and slow down or stop cancer growth. Pembrolizumab in combination chemotherapy may be a safe and effective alternative treatment option for frail patients with Hodgkin lymphoma who can't receive standard anthracycline-based treatment.

Start Date01 Jul 2026

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

100 Clinical Results associated with Gemcitabine Hydrochloride

100 Translational Medicine associated with Gemcitabine Hydrochloride

100 Patents (Medical) associated with Gemcitabine Hydrochloride

12,577

Literatures (Medical) associated with Gemcitabine Hydrochloride

01 Jan 2026·MOLECULAR BIOTECHNOLOGY

Exploring the Effects of Opioid-Related Drugs on the Clinical Outcome of Prostate Cancer Patients Via Integrated Bioinformatics Analysis

Article

Author: Zhang, Yunxuan ; Cao, Qi ; Miao, Qi ; Liu, Yuenan ; Zhang, Xiaoping ; Chen, Kailei

Opioids are the primary regimens for perioperative analgesia with controversial effects on oncological survival. The underlying mechanism remains unexplored. This study developed survival-related gene co-expression networks based on RNA-seq and clinical characteristics from TCGA cohort. Two survival-related networks were identified, and drug-induced transcriptional profiles were predicted. Immune cell infiltration algorithm, least absolute shrinkage and selection operator (LASSO) regression, and cox proportional models were executed to explore the correlation between opioid-related drugs and prostate cancer patient prognosis. The opioid receptor agonists, represented by tramadol, were evidenced for anti-survival effects on prostate cancer by facilitating the DNA replication and cell cycle, and immune cell infiltration. Conversely, opioid receptor antagonists showed pro-survival effects. A novel prognostic model containing CNIH2, MCCC1, and Gleason scores was established and validated in two independent cohorts. This study revealed opioids' effect on prostate cancer progression, and provided a novel model to predict these regulations in clinical outcomes.

01 Jan 2026·Gan to kagaku ryoho. Cancer & chemotherapy

[Evolving Pharmacotherapy for Bladder Cancer-From Non-Muscle-Invasive to Metastatic Disease-Development of Novel Therapies for BCG-Unresponsive NMIBC].

Article

Author: Inoue, Keiji ; Shigehisa, Ryu ; Fukata, Satoshi

Bladder cancer is a common malignancy in the elderly, with approximately 75% of cases diagnosed as non-muscle-invasive bladder cancer(NMIBC).Although transurethral resection of bladder tumor(TURBT)is the standard initial treatment, recurrence rates remain high, and intravesical Bacillus Calmette-Guérin(BCG)instillation has long been used as an adjuvant therapy.However, about 30% of patients develop BCG-unresponsive disease despite adequate BCG administration.Radical cystectomy is recommended in such cases, but its invasiveness and impact on quality of life(QOL)often make it impractical in real-world settings.Thus, the development of novel bladder-preserving treatments is urgently needed.In recent years, diverse approaches including immune checkpoint inhibitors(ICI), gene therapy, drug delivery systems(DDS), and oncolytic virus-based therapies have been actively investigated, with numerous clinical trials ongoing worldwide.Importantly, pembrolizumab, nadofaragene firadenovec, and N-803 in combination with BCG have received FDA approval, representing major advances in the management of BCG-unresponsive NMIBC.In addition, promising agents such as TAR-200, cretostimogene grenadenorepvec, and detalimogene voraplasmid are under clinical evaluation.These advances indicate the potential for novel strategies that enable bladder preservation while achieving tumor control.Future challenges include validation of long-term outcomes, establishment of evidence through randomized controlled trials, and regulatory approval and reimbursement in Japan.Expansion of therapeutic options is expected to improve both prognosis and QOL in this high-risk population.

01 Dec 2025·ADVANCED MATERIALS

Rational Design of Metal–Organic Frameworks for Pancreatic Cancer Therapy: from Machine Learning Screening to In Vivo Efficacy

Article

Author: Jon Ostolaza-Paraiso ; Dhruv Menon ; João Conde ; Sergio Mercado ; Jhenifer Oliveira ; Xu Chen ; Bárbara B. Mendes ; David Fairen-Jimenez ; João Conniot ; Francesca Melle

Abstract:

Despite improvements in cancer survival rates, metastatic and surgery‐resistant cancers, such as pancreatic cancer, remain challenging, with poor prognoses and limited treatment options. Enhancing drug bioavailability in tumors, while minimizing off‐target effects, is crucial. Metal–organic frameworks (MOFs) have emerged as promising drug delivery vehicles owing to their high loading capacity, biocompatibility, and functional tunability. However, the vast chemical diversity of MOFs complicates the rational design of biocompatible materials. This study employed machine learning and molecular simulations to identify MOFs suitable for encapsulating gemcitabine, paclitaxel, and SN‐38, and identified PCN‐222 as an optimal candidate. Following drug loading, MOF formulations are improved for colloidal stability and biocompatibility. In vitro studies on pancreatic cancer cell lines have shown high biocompatibility, cellular internalization, and delayed drug release. Long‐term stability tests demonstrated a consistent performance over 12 months. In vivo studies in pancreatic tumor‐bearing mice revealed that paclitaxel‐loaded PCN‐222, particularly with a hydrogel for local administration, significantly reduced metastatic spread and tumor growth compared to the free drug. These findings underscore the potential of PCN‐222 as an effective drug delivery system for the treatment of hard‐to‐treat cancers.

873

News (Medical) associated with Gemcitabine Hydrochloride

06 Mar 2026

·www.biospace.com

Immuneering Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates

- 64% overall survival observed at 12 months in ongoing Phase 2a trial of atebimetinib + mGnP in first-line pancreatic cancer patients, well above the standard of care benchmark from GnP of 35% overall survival; On track for expanded pancreatic cancer cohort data readout in first half of 2026 - - On track to dose first patient in p ivotal Phase 3 MAPKeeper 301 trial of atebimetinib + mGnP in patients with first-line metastatic pancreatic cancer in mid-2026 - - Dosing in Phase 2 trial of atebimetinib + Libtayo ® in patients with first-line RAS-mutant non-small cell lung cancer expected to begin in second half of 2026 - - Ended 2025 with $217 million in cash, cash equivalents and marketable securities with anticipated runway into 2029 - NEW YORK, March 06, 2026 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided business updates. “2025 was a transformative year for Immuneering. We reported 64% overall survival at 12 months in first-line pancreatic cancer patients treated with atebimetinib + mGnP, well above the benchmark for GnP standard of care. We designed atebimetinib with three mechanisms well-established to improve survival, and we believe these survival gains are driven by atebimetinib shrinking tumors durably with less resistance, preserving body mass by countering cachexia, and minimizing side effects to maximize combinability and performance status," said Ben Zeskind, Ph.D., Chief Executive Officer of Immuneering. “We also made rapid progress in preparation for our pivotal Phase 3 trial in first-line pancreatic cancer patients, MAPKeeper 301, having secured alignment with both the FDA and EMA on our trial design, and we are on track to dose the first patient mid-year. With cash runway expected into 2029, uniquely encouraging clinical data, and a solid pipeline, we are strongly positioned to deliver on our mission to help patients live longer and feel better.” Recent Corporate Highlights Reported 64% Overall Survival at 12 Months in First-Line Pancreatic Cancer Patients Treated with Atebimetinib + mGnP: In January, the Company announced positive updated survival and safety data from its ongoing Phase 2a trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients (N=34), with 13.4 months median follow up. Immuneering reported 64% overall survival (OS) observed at 12 months as of the December 15, 2025 data cutoff date. Atebimetinib (320mg dosed once daily) + mGnP was observed to demonstrate a favorable tolerability profile, with only two categories of adverse events observed at or above the grade 3 level in more than 10% of patients (neutropenia and anemia, both of which are categories commonly observed with standard of care chemotherapy), in comparison to toxicity profiles for other combinations in the front line pancreatic cancer setting, which demonstrate significantly more grade 3 and higher adverse events. No head-to-head clinical trial has been conducted evaluating atebimetinib and other candidates or products. Differences exist between trial designs, subject characteristics and other factors, and caution should be exercised when comparing data across studies. Secured Alignment with FDA and EMA on pivotal Phase 3 Atebimetinib Trial for First-Line Metastatic Pancreatic Cancer Patients: In December, Immuneering announced that it expected to dose the first patient in its planned global pivotal Phase 3 registrational trial, MAPKeeper 301, in first-line pancreatic cancer patients in mid-2026, evaluating atebimetinib (320 mg QD) in combination with modified gemcitabine and nab-paclitaxel (mGnP), compared with gemcitabine and nab-paclitaxel (GnP) alone. The Company remains on track with this guidance. Notably, the Company completed its End-of-Phase 2 (EOP2) interactions with the U.S. Food and Drug Administration (FDA) and received scientific advice from the European Medicines Agency (EMA). Immuneering achieved alignment with both agencies on the key elements of the proposed Phase 3 trial. Added to the Nasdaq Biotechnology Index (NBI): On December 22, 2025, Immuneering was added to the Nasdaq Biotechnology Index. Anticipated Near-Term Milestones Immuneering is planning for several near-term anticipated milestones related to atebimetinib, including: Q2 2026: Report updated circulating tumor DNA data on acquired alterations at a major scientific meeting. 1H 2026: Report updated survival data from over 50 first-line pancreatic cancer patients treated with atebimetinib + mGnP. Mid-2026: Dose first patient in pivotal Phase 3 MAPKeeper clinical trial of atebimetinib + mGnP in first-line pancreatic cancer. 2H 2026: Dose first patient in trial of atebimetinib + Libtayo® in RAS-mutant first-line non-small cell lung cancer. Fourth Quarter and Full Year 2025 Financial Highlights Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2025 were $217.0 million, compared with $36.1 million as of December 31, 2024. Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2025 were $9.3 million compared to $14.9 million for the fourth quarter of 2024. Full year 2025 R&D expenses were $42.0 million compared to $48.0 million for full year 2024. R&D expenses for the fourth quarter and full year 2025 decreased compared to the same respective periods in 2024, primarily driven by reduced spend related to the Company's product candidate envometinib (IMM-6-415) and certain pre-clinical activities, in addition to decreased personnel related costs. This was partially offset by increased clinical and regulatory consulting resources utilized during the period to support atebimetinib's ongoing development and regulatory readiness activities. General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2025 were $4.5 million compared to $3.7 million for the fourth quarter of 2024. Full year 2025 G&A expenses were $17.3 million compared to $16.1 million for full year 2024. G&A expenses for the fourth quarter and full year 2025 increased compared to the same respective periods in 2024, primarily driven by increased employee-related costs and external professional fees, in addition to increased public filing costs associated with the Company's various financing efforts. Net Loss: Net loss attributable to common stockholders was $11.6 million, or $0.18 per share, for the quarter ended December 31, 2025, compared to $18.1 million, or $0.58 per share, for the quarter ended December 31, 2024. Net loss attributable to common stockholders for full year 2025 was $56.0 million, or $1.27 per share, compared to $61.0 million, or $2.04 per share, for full year 2024. 2026 Financial Guidance Based on cash, cash equivalents and marketable securities as of December 31, 2025, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into 2029. About Atebimetinib Atebimetinib is the first in a new category of oral drug candidates, Deep Cyclic Inhibitors (DCIs), designed to improve overall survival by three mechanisms: shrinking tumors durably with less resistance, preserving body mass by countering cachexia, and minimizing side effects to maximize performance status and combinability. Each of these mechanisms has been well established to improve survival in published studies. DCIs challenge the conventional model of sustained or continuous inhibition in oncology. Whereas most therapies are designed for sustained inhibition, driving cancer to adapt and develop resistance so tumors shrink quickly but temporarily, DCIs are designed to pulse faster than tumors can adapt, so tumors shrink slowly but durably. Moreover, DCIs aim to restore full transient signaling to healthy cells, with the goal of leading to fewer adverse events. Atebimetinib targets MEK, a key control point in the MAPK pathway (RAS-RAF-MEK-ERK), which is pathologically activated in a majority of cancers, including approximately 97% of pancreatic cancers. Targeting MEK blocks a broader range of MAPK pathway alterations because it is further downstream, creating the potential for more durable benefit. About Immuneering Corporation Immuneering is a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive. The Company is developing an entirely new category of cancer medicines, Deep Cyclic Inhibitors, designed to improve overall survival by three mechanisms: shrinking tumors durably with less resistance, preserving body mass by countering cachexia, and minimizing side effects to maximize performance status and combinability. Immuneering’s lead product candidate, atebimetinib, is an oral, once-daily Deep Cyclic Inhibitor of MEK, designed to improve survival across many cancer indications, including MAPK pathway-driven tumors such as pancreatic cancer. The company expects to dose the first patient in mid-2026 in MAPKeeper 301, a globally randomized pivotal Phase 3 trial evaluating atebimetinib in combination with chemotherapy in first-line pancreatic cancer patients. The Company’s development pipeline also includes additional combination opportunities and early-stage programs. For more information, please visit Forward-Looking Statements This press release contains forward-looking statements, including within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding: the treatment potential of atebimetinib, alone or in combination with other agents to treat cancer, including modified Gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer and its potential to deliver overall survival with both durability and tolerability; the ability of the three design mechanisms of atebimetinib to improve overall survival; the timing of commencing dosing in the Phase 3 trial; the ability of atebimetinib + mGnP to deliver a more durable and compounding benefit, including compared to standard of care; the timing, venue and content of future data releases and presentations and for the phase 2 results to continue to trend positively; and the timing for the initiation of additional atebimetinib clinical trial combination arms, including in non-small cell lung cancer. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the risks inherent in oncology drug research and development, including target discovery, target validation, lead compound identification, and lead compound optimization; we have incurred significant losses, are not currently profitable and may never become profitable; our projected cash runway; our need for additional funding; our unproven approach to therapeutic intervention; our ability to address regulatory questions and the uncertainties relating to regulatory filings, reviews and approvals; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in or failure to obtain regulatory approvals; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; costs and resources of operating as a public company; and unfavorable or no analyst research or reports. These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the period ended December 31, 2025, and our other reports filed with the U.S. Securities and Exchange Commission, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Investor Contacts: Courtney Dugan Cdugan@immuneering.com Media Contact: Gina Nugent gina@nugentcommunications.com IMMUNEERING CORPORATION CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) Three Months Ended December 31, Twelve Months Ended December 31, 2025 2024 2025 2024 Operating expenses Research and development $ 9,254,626 $ 14,857,166 $ 42,048,461 $ 47,964,388 General and administrative 4,490,776 3,693,672 17,298,241 16,077,746 Amortization of intangible asset 7,317 7,317 29,267 29,267 Total operating expenses 13,752,719 18,558,155 59,375,969 64,071,401 Loss from operations (13,752,719 ) (18,558,155 ) (59,375,969 ) (64,071,401 ) Other income (expense) Interest income 1,861,044 415,240 3,039,406 2,593,300 Other income, net 311,665 91,430 311,665 441,493 Net loss $ (11,580,010 ) $ (18,051,485 ) $ (56,024,898 ) $ (61,036,608 ) Net loss per share attributable to common stockholders, basic and diluted $ (0.18 ) $ (0.58 ) $ (1.27 ) $ (2.04 ) Weighted-average common shares outstanding, basic and diluted 64,590,066 31,050,448 44,011,830 29,981,565 Other comprehensive income: Unrealized gain from marketable securities 81,332 (7,846 ) 81,332 778 Comprehensive Loss $ (11,498,678 ) $ (18,059,331 ) $ (55,943,566 ) $ (61,035,830 ) IMMUNEERING CORPORATION CONSOLIDATED BALANCE SHEETS December 31, 2025 December 31, 2024 Assets Current assets: Cash and cash equivalents $ 128,645,025 $ 36,144,720 Marketable securities, current 44,186,244 — Prepaids and other current assets 3,414,685 3,442,849 Total current assets 176,245,954 39,587,569 Marketable securities, non-current 44,183,186 — Property and equipment, net 938,481 1,122,865 Goodwill 6,690,431 6,690,431 Intangible asset, net 321,147 350,413 Right-of-use assets, net 3,322,249 3,667,352 Other assets 283,562 1,295,783 Total assets $ 231,985,010 $ 52,714,413 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 1,542,737 $ 1,958,536 Accrued expenses 7,842,367 4,973,129 Other liabilities 291,513 233,665 Lease liabilities 397,104 338,438 Total current liabilities 10,073,721 7,503,768 Long-term liabilities: Lease liabilities, net of current portion 3,427,321 3,824,419 Total liabilities 13,501,042 11,328,187 Commitments and contingencies Stockholders’ equity: Preferred stock, $0.001 par value; 10,000,000 shares authorized at December 31, 2025 and December 31, 2024; 0 shares issued or outstanding at December 31, 2025 and December 31, 2024 — — Class A common stock, $0.001 par value, 200,000,000 shares authorized at December 31, 2025 and December 31, 2024; 64,648,230 and 31,050,448 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively 64,648 31,050 Class B common stock, $0.001 par value, 20,000,000 shares authorized at December 31, 2025 and December 31, 2024; 0 shares issued and outstanding at December 31, 2025 and December 31, 2024 — — Additional paid-in capital 498,658,072 265,650,362 Accumulated other comprehensive income 81,332 — Accumulated deficit (280,320,084 ) (224,295,186 ) Total stockholders' equity 218,483,968 41,386,226 Total liabilities and stockholders' equity $ 231,985,010 $ 52,714,413

Phase 3Phase 2Clinical ResultFinancial Statement

05 Mar 2026

·www.biospace.com

Compass Therapeutics Reports 2025 Financial Results and Provides Corporate Update

In the Phase 2/3 COMPANION-002 study of tovecimig (DLL4 x VEGF-A bispecific antibody) in patients with biliary tract cancer, the prespecified event threshold of 80% overall survival (OS) events was reached in Q1 2026; as a result, the analyses of progression-free survival (PFS) and OS are expected to be reported in April. Based on previously reported responses in patients with triple-negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC) in the Phase 1 study of CTX-8371 (PD-1 x PD-L1 bispecific antibody), expansion cohorts are now open and enrolling patients with these tumor types; based on an additional response in a patient with Hodgkin lymphoma, a further expansion cohort of patients with Hodgkin lymphoma will begin shortly. The IND application for CTX-10726 (PD-1 x VEGF-A bispecific antibody) received FDA clearance and the Phase 1 study will be open for enrollment in Q1. Bing Gong, PhD has been promoted to Chief Scientific Officer. Dr. Gong joined Compass in 2015 and has been instrumental in the expansion and advancement of the Compass discovery and development pipeline. $209 million in cash and marketable securities at year end 2025, which is expected to fund operations into 2028. BOSTON, March 05, 2026 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today reported full 2025 financial results and provided a business update. “2025 marked a year of significant progress for Compass, highlighted by our lead asset tovecimig successfully meeting the primary endpoint of overall response rate in the COMPANION-002 Phase 2/3 study in patients with biliary tract cancer. We are excited to report the results of the key secondary endpoints next month,” said Thomas Schuetz, MD, PhD, Chief Executive Officer and Vice Chairman of the Board of Directors. “The upcoming tovecimig PFS/OS data release could be transformational for the company, and we are looking forward to the new option it would bring for patients with biliary tract cancer.” “Our novel PD-1 x PD-L1 checkpoint inhibitor, CTX-8371, also demonstrated strong clinical activity this past year, with three robust responses in patients with both solid tumors and hematologic malignancies, all observed in heavily pre-treated patients who received prior checkpoint inhibitor therapies. We also continued to advance our other clinical-stage assets, CTX-471 and CTX-10726.” ”2026 is poised to be a defining year for Compass,” Dr. Schuetz continued, “and we move forward with an expanded leadership team, welcoming Cyndi Sirard as CMO and Arjun Prasad as CCO, and promoting Bing Gong to CSO. Finally, our progress is bolstered by our strong financial position with $209 million of cash and marketable securities, providing runway into 2028.” 2025 Accomplishments and 2026 Pipeline Updates: Tovecimig (DLL4 and VEGF-A bispecific antibody) The analyses of key secondary endpoints from the COMPANION-002 Phase 2/3 randomized study, including PFS and OS, are expected in April. The Phase 2 study of tovecimig in a broader set of patients with DLL4+ tumor types is expected to initiate mid-2026 following a comprehensive analysis of the complete data set from the COMPANION-002 trial. The investigator sponsored trial (IST) of tovecimig in combination with the current first-line, standard-of-care regimen of gemcitabine, cisplatin, and durvalumab in patients with BTC ( NCT05506943 ) is ongoing. CTX-8371 (PD-1 x PD-L1 bispecific antibody) Cohort expansions for CTX-8371 are open for enrollment in patients with TNBC (n=28) and NSCLC (n=28) in the post-checkpoint inhibitor setting. TNBC and NSCLC were selected based on the deep and durable responses previously observed in these indications in the dose escalation portion of the study. Half of the patients with each tumor type will be dosed at 3.0 mg/kg and half will be dosed at 10.0 mg/kg. Initial data from these cohort expansions, as well as available data from the Phase 1 dose-escalation portion of the study, are expected to be presented at a major medical conference in the second quarter of 2026. Based on a previously reported response in a patient with Hodgkin lymphoma (HL), a third cohort (n=12) will be added to the expansion study in patients with HL, also at the 3.0 mg/kg and 10.0 mg/kg dose levels. CTX-10726 (PD-1 x VEGF-A bispecific antibody) The FDA cleared the IND submission for CTX-10726 in early 2026 and the Phase 1 study will be open for enrollment in Q1 with clinical data in the second half of the year. The Phase 1 multiple ascending dose-escalation study will include four doses (0.3, 1.0, 3.0, and 10.0 mg/kg) in a 3+3 format. The multi-center study will enroll patients with a prioritized set of solid tumor indications, including patients with locally advanced, unresectable or metastatic renal cell carcinoma, gastroesophageal cancer, hepatocellular carcinoma, and endometrial cancer, in whom standard of care therapies have failed. CTX-10726 is a tetravalent PD-1 x VEGF-A bispecific antibody discovered and engineered at Compass. CTX-10726 exhibits more potent PD-1 blockade compared with data reported for other drugs in the class and Compass believes it has a unique understanding of aspects of its mechanism of action that will guide development. CTX-471 (CD137 or 4-1BB agonist antibody) Initiation of the Phase 2 trial of CTX-471 in patients with tumors expressing NCAM (CD56) is expected in mid-2026. Financial Results Net loss for the year ended December 31, 2025, was $66.5 million or $0.42 per common share, compared to $49.4 million or $0.36 per common share for the same period in 2024. Research and Development (R&D) Expenses R&D expenses were $56.0 million for the year ended December 31, 2025, as compared to $42.3 million for the same period in 2024, an increase of $13.7 million or 32%. The increase was primarily attributable to an increase in manufacturing expenses related to tovecimig of $7.7 million and manufacturing expenses related to CTX-10726 of $5.9 million. General and Administrative (G&A) Expenses G&A expenses were $16.9 million for the year ended December 31, 2025, as compared to $15.1 million for the same period in 2024, an increase of $1.8 million or 12%. The increase was primarily driven by pre-commercialization expenses of $0.7 million and advisory fees of $0.5 million. Cash Position As of December 31, 2025, cash and marketable securities were $209 million as compared to $127 million as of December 31, 2024, an increase of $82 million, with an anticipated cash runway into 2028. During 2025, $49 million of net cash was used in operating activities, and this was offset by net proceeds from an underwritten public offering of $129 million. About Compass Therapeutics Compass Therapeutics, Inc. is a clinical-stage oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. The company’s scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth. Compass has built a robust pipeline of novel product candidates designed to target multiple critical biological pathways required for an effective anti-tumor response. These pathways include modulation of the microvasculature via angiogenesis-targeted agents, induction of a potent immune response via activators on effector cells in the tumor microenvironment, and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. The company plans to advance its product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data. The Company was founded in 2014 and is headquartered in Boston, Massachusetts. For more information, visit the Compass Therapeutics website at Forward-Looking Statements This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to Compass’s financial position to continue advancing its product candidates, expectations about cash runway, business and development plans, and statements regarding Compass’s product candidates, including their development and clinical trial milestones such as the expected trial design, timing of enrollment, patient dosing and data readouts, regulatory plans with respect to Compass’s product candidates and the therapeutic potential thereof. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, Compass’s ability to raise the additional funding it will need to continue to pursue its business and product development plans, the inherent uncertainties associated with developing product candidates and operating as a development stage company, Compass’s ability to identify additional product candidates for development, Compass’s ability to develop, complete clinical trials for, obtain approvals for and commercialize any of its product candidates, competition in the industry in which Compass operates and market conditions. These forward-looking statements are made as of the date of this press release, and Compass assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents Compass files with the U.S. Securities and Exchange Commission (SEC) available at .gov , including without limitation Compass’s latest Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent filings with the SEC. Investor Contact ir@compasstherapeutics.com Media Contact Anna Gifford, Chief of Staff media@compasstherapeutics.com 617-500-8099 Compass Therapeutics, Inc. and Subsidiaries Condensed Consolidated Statements of Operations (In thousands, except per share data) Three Months Ended December 31, Year Ended December 31, 2025 2024 2025 2024 (unaudited) License revenue $ — $ — $ — $ 850 Operating expenses: Research and development 13,674 13,034 55,969 42,342 General and administrative 4,316 3,537 16,870 15,133 Total operating loss (17,990 ) (16,571 ) (72,839 ) (56,625 ) Other income 2,274 1,540 6,350 7,250 Net loss $ (15,716 ) $ (15,031 ) $ (66,489 ) $ (49,375 ) Net loss per share - basic and diluted $ (0.09 ) $ (0.11 ) $ (0.42 ) $ (0.36 ) Weighted average shares outstanding 184,844 137,742 157,695 137,384 Compass Therapeutics, Inc. and Subsidiaries Condensed Consolidated Balance Sheets (In thousands, except par value) December 31, 2025 2024 Assets Current assets: Cash and cash equivalents $ 30,643 $ 43,483 Marketable securities 178,263 83,239 Prepaid expenses and other current assets 913 6,029 Total current assets 209,819 132,751 Property and equipment, net 102 353 Operating lease, right-of-use ("ROU") asset 9,099 6,731 Restricted cash 568 568 Total assets $ 219,588 $ 140,403 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 1,585 $ 2,249 Accrued expenses 11,383 6,287 Operating lease obligations, current portion 1,000 338 Total current liabilities 13,968 8,874 Operating lease obligations, net of current portion 8,829 6,296 Total liabilities 22,797 15,170 Total stockholders' equity 196,791 125,233 Total liabilities and stockholders' equity $ 219,588 $ 140,403

Phase 1Financial StatementINDPhase 2Executive Change

03 Mar 2026

·www.biospace.com

Propanc Biopharma’s Lead Asset PRP Shows >85% Tumor Growth Inhibition in Preclinical Pancreatic Models

PRP May Outshine Traditional Therapies in a Booming $4.4 Billion Market MELBOURNE, Australia, March 03, 2026 (GLOBE NEWSWIRE) -- Propanc Biopharma, Inc. (Nasdaq: PPCB) (“Propanc” or the “Company”), a biopharmaceutical company focused on developing novel treatments for chronic diseases, including recurrent and metastatic cancer, today highlights the potential of its lead asset, PRP, as a novel therapeutic approach to the treatment and prevention of metastatic cancer from solid tumors, especially more aggressively spreading, less differentiated tumors, which offer a poor patient prognosis. Pancreatic cancer is one of the deadliest cancers, with a five-year survival rate stuck at just 13% and no real progress has been made in recent years. To put that into perspective, overall cancer survival is 70%. Standard treatments like chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel), targeted therapies (e.g., KRAS inhibitors), and emerging options (immunotherapies, tumor-treating fields like Optune Pax) extend life modestly but often bring harsh side effects, resistance, and limited success against this aggressive, metastasis-prone disease. Enter Propanc's PRP—a promising investigational proenzyme therapy (trypsinogen + chymotrypsinogen in a 1:6 ratio) delivered intravenously. Unlike cytotoxic drugs that kill dividing cells broadly, PRP targets cancer stem cells, blocks metastasis by suppressing epithelial-mesenchymal transition (EMT), disrupts the tumor microenvironment, curbs angiogenesis, and boosts chemosensitivity—potentially making standard treatments more effective with far less toxicity. Preclinical data shines: >85% tumor growth inhibition in pancreatic models, reduced fibrosis and resistance markers, and a gentler profile (no major side effects in limited prior human use). A small compassionate study (rectal version) extended survival from ~5.6 to 9 months in advanced cases. PRP vs. Current Treatment Options: Chemo: PRP could sensitize resistant tumors and cut doses/side effects. Targeted drugs: Broader attack on stem cells and spread, not just single mutations. Immunotherapy: May warm up “cold” pancreatic tumors by remodeling the microenvironment. According to industry sources the global pancreatic cancer treatment market is valued at ~$4.42 billion in 2026 and projected to explode to $14.43 billion by 2034 (CAGR ~16%), fueled by rising cases and demand for better options. Propanc is gearing up for a Phase 1b First-In-Human trial in 2026 (30–40 advanced solid tumor patients), backed by fresh funding ($100M facility), new patents, and FDA Orphan Drug status for pancreatic cancer. “We are excited about PRP’s potential to transform cancer care by targeting the underlying mechanisms of metastasis with a mechanism that could offer meaningful advantages over existing therapies,” said James Nathanielsz, Propanc’s Chief Executive Officer. “PRP remains experimental—no large human efficacy data yet—but its multi-targeted, low-toxicity approach could redefine care for a disease desperate for breakthroughs,” Mr. Nathanielsz concludes. About Propanc Biopharma, Inc. Propanc Biopharma, Inc. (Nasdaq: PPCB) is developing a novel approach to preventing cancer recurrence and metastasis by targeting and eradicating cancer stem cells through proenzyme activation. The Company’s lead product candidate, PRP, is designed to address the underlying drivers of cancer proliferation and spread. More information: Forward-Looking Statements All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to the Company’s expectations regarding its market position and market opportunity, expectations and plans as to its product development, manufacturing and sales, and relations with its partners and investors, made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections regarding its business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expect,” “intend,” “plan,” “project,” “believe,” “estimate,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond the Company’s control. Forward-looking statements are not guarantees of future actions or performance. Actual results may differ materially from those in the forward-looking statements because of several factors, including, without limitation, risks and uncertainties related to market conditions, as well as those risks described under “Risk Factors” in the prospectus related to the proposed offering and those described in the Company’s filings with the SEC. The Company undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available. Company: Propanc Biopharma, Inc. James Nathanielsz +61-3-9882-0780 info@propanc.com Investor Contact: irteam@propanc.com

ImmunotherapyOrphan Drug

100 Deals associated with Gemcitabine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01155	Gemcitabine Hydrochloride	L01BC05	DB00441

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Non-Muscle Invasive Bladder Neoplasms	United States	Janssen Biotech, Inc.	09 Sep 2025
Locally Advanced Lung Non-Small Cell Carcinoma	Australia	Sandoz Pty Ltd.	02 Dec 2008
Locally Advanced Pancreatic Adenocarcinoma	Australia	Sandoz Pty Ltd.	02 Dec 2008
metastatic non-small cell lung cancer	Australia	Sandoz Pty Ltd.	02 Dec 2008
Pancreatic adenocarcinoma metastatic	Australia	Sandoz Pty Ltd.	02 Dec 2008
Recurrent ovarian cancer	Australia	Sandoz Pty Ltd.	02 Dec 2008
Transitional Cell Carcinoma	Japan	Eli Lilly & Co.	25 Nov 2008
Bladder Cancer	Brazil	Libbs Farmacêutica Ltda.	26 May 2008
Biliary Tract Neoplasms	Japan	Eli Lilly & Co.	31 Aug 2001
Lymphoma	Japan	Eli Lilly & Co.	31 Aug 2001
Ovarian Cancer	Japan	Eli Lilly & Co.	31 Aug 2001
Breast Cancer	United States	Eli Lilly & Co.	15 May 1996
Metastatic breast cancer	United States	Eli Lilly & Co.	15 May 1996
Non-Small Cell Lung Cancer	United States	Eli Lilly & Co.	15 May 1996
Pancreatic adenocarcinoma	United States	Eli Lilly & Co.	15 May 1996
Pancreatic Cancer	United States	Eli Lilly & Co.	15 May 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced biliary tract cancer	Phase 3	Taiwan Province	InnoPharmax, Inc.	01 Jul 2025
Recurrent Bladder Cancer	Phase 3	United States	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	China	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Japan	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Argentina	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Belgium	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Brazil	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	France	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Germany	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Italy	Janssen Research & Development LLC	09 Apr 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO_GU2026	Not Applicable	Non-Muscle Invasive Bladder Neoplasms	133	BCG	naqermwcxv(esyabnpgzd) = phqgnzrzkt mqegdrgytr (dhpmkfmgoy ) View more	Negative	26 Feb 2026
				sequential gemcitabine and docetaxel (Gem/Doce)	naqermwcxv(esyabnpgzd) = jbgmmlelmd mqegdrgytr (dhpmkfmgoy ) View more
ASCO_GU2026	Not Applicable	Muscle Invasive Bladder Carcinoma	98	Cisplatin	zyfirsflag(qdzbaasrcu) = mkoyavyyed gyemckurcy (fdhlvpszqg ) View more	Positive	26 Feb 2026
				5-FU+MMC	zyfirsflag(qdzbaasrcu) = dqgtjvuygr gyemckurcy (fdhlvpszqg ) View more
NCT04628767 (EA8192, ASCO_GU2026)	Phase 2	Renal Pelvis and Ureter Urothelial Carcinoma Neoadjuvant	30	Gemcitabine/Durvalumab	pyioyjpfsd(aeeuqpoqnt) = cibjkyiusl zcgzotkkhk (bejpgpqhpf, 3.0 - 25.2) View more	Positive	26 Feb 2026
NCT04179162 (ALLIANCE A032303, ASCO_GU2026)	Phase 1/2	Recurrent Bladder Cancer	52	Gemcitabine + BCG	zynkmmxwpb(laugeylpfn) = opjnxjyzcr nclsuagwpg (ookvzbcutl ) View more	Positive	26 Feb 2026
ASCO_GU2026	Not Applicable	Muscle Invasive Bladder Carcinoma Neoadjuvant	517	Gemcitabine 800 mg/m2	vaqeqbrcxj(idzelgufym): P-Value = 0.012 View more	Positive	26 Feb 2026
				Gemcitabine 1000 mg/m2
NCT03366766 (CTgov)	Phase 2	Non-small cell lung cancer stage I \| Resectable Lung Non-Small Cell Carcinoma \| Non-small cell lung cancer stage IIIA ... View more	14	Nivolumab+cisplatin+Pemetrexed Disodium (Cohort I (Nivolumab, Cisplatin, Pemetrexed Disodium))	cesdytdwev = oxofkttsmd rxlyiehbhp (nulyjatgcy, govddgqdtm - kbbtvcdqxv) View more	-	20 Feb 2026
				nivolumab+Gemcitabine Hydrochloride (Cohort I (Nivolumab, Cisplatin, Gemcitabine Hydrochloride))	rdgelmsyhr = mthdjmrkgl tsvpahurtd (yghwlgjtsv, lvizyetykh - kttfcrxocw)
NCT04919512 (SunRISe-4, CTgov)	Phase 2	Muscle Invasive Bladder Urothelial Carcinoma \| Muscle Invasive Bladder Carcinoma \| Bladder Cancer	163	Cetrelimab (TAR-200 + Cetrelimab)	hzuknadecy = hugukyomvs vucexxfvvk (opiwisbino, dpimbpzqbz - kvkpqrdnhs) View more	-	17 Feb 2026
				Cetrelimab (Cetrelimab Alone)	hzuknadecy = remcygswly vucexxfvvk (opiwisbino, whmtvuzcae - hjfqpsifog)
NCT03693807 (CTgov)	Phase 2	Colorectal Liver Metastases \| Colorectal Cancer \| Bile Duct Neoplasms	35	Cetuximab+Gemcitabine+Floxuridine (FUDR)+Oxaliplatin+Irinotecan (CPT-11)+Panitumumab+Fluorouracil (Group 1: Unresectable Liver Metastases From Colorectal Cancer)	gbujpggnbp(laltraovdd) = jlbdppbysu ndbydirfde (dyrxshshge, bgbnuvbpvu - vpdogvtjhx) View more	-	06 Feb 2026
				Cetuximab+Gemcitabine+Floxuridine (FUDR)+Oxaliplatin+Irinotecan (CPT-11)+Panitumumab+Fluorouracil (Group 2: Resectable Liver Metastases From Colorectal Cancer)	gbujpggnbp(laltraovdd) = kthxvyfeak ndbydirfde (dyrxshshge, cunubnknup - kiyixabjef) View more
NCT04524702 (CTgov)	Phase 2	Pancreatic adenocarcinoma metastatic \| Advanced Pancreatic Adenocarcinoma	10	Hydroxychloroquine+Nab-paclitaxel+Gemcitabine+Paricalcitol	uqvlvmgbcr = ibnpopyfob vuanqecwui (iwurcdpaeh, afkqwlgjjv - wrazbhcvwn) View more	-	23 Jan 2026
NCT03377491 (PANOVA-3, CTgov)	Phase 3	Pancreatic Adenoma \| Locally Advanced Pancreatic Adenocarcinoma	571	Nab-paclitaxel+Gemcitabine (TTFields + Standard of Care)	aexpgxelxc(kmexetggao) = ocnolnarod ykucatvzvr (owjjjqdrdo, rntdxfhirm - yukmfojsbr) View more	-	21 Jan 2026
				Nab-paclitaxel+Gemcitabine (Standard of Care)	aexpgxelxc(kmexetggao) = lgwqdzluhv ykucatvzvr (owjjjqdrdo, mlklufhmpp - znggmdppis) View more

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