Author: Ravi Shankar

VANCOUVER, British Columbia, Oct. 24, 2026 (GLOBE NEWSWIRE) — Teck Resources Limited (TSX: TECK.A and TECK.B, NYSE: TECK) (“Teck”) announced today that strike action by United Steelworkers (USW) Local 7619 has commenced at Teck’s Highland Valley Copper (HVC) Operations in B.C.

Operations are currently continuing at a reduced capacity. The impact on overall production will depend on the duration of the labour action. Contingency plans are in place with the priority to maintain safety and environmental management during labour action.

Teck is committed to reaching a collective agreement that is fair and reasonable for employees and supports the ongoing viability of the operation. 

Forward-Looking Statements
This news release contains certain forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 and forward-looking information as defined in the Securities Act (Ontario). Forward-looking statements and information can be identified by statements that certain actions, events or results “may”, “estimate”, “could”, “take”, “advantage”, “should”, “expect”, “would”, “might” or “will” be taken, occur or achieved. Forward-looking statements include statements regarding Teck’s expectations regarding our ability to continue operations and manage site activities as currently expected and the potential impact of the strike on production and previously issued guidance.

Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of Teck to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements are based on a number of assumptions, including, but not limited to, assumptions regarding general business and economic conditions, our ability to continue to operate and manage site activities as currently expected, our ability to successfully negotiate and finalize the collective bargaining agreement, dependence on key personnel, employee and union relations, the timing, nature and impact of the labour disruption, including impacts on production and our previously issued guidance, our ability to successfully implement contingency plans, and other matters.

Factors that may cause actual results to vary include, but are not limited to, our ability to continue to operate and manage site activities as currently expected, our ability successfully negotiate and finalize the collective bargaining agreement, the timing, nature and impact of any labour disruptions, including on production and our previously issued guidance, our ability to implement contingency plans as currently anticipated or at all, and other risk factors impacting Teck’s business as detailed in Teck’s annual information form and in its public filings with Canadian securities administrators and the U.S. Securities and Exchange Commission. Teck does not assume the obligation to revise or update these forward-looking statements after the date of this document, except as may be required under applicable securities laws.

About Teck
Teck is a leading Canadian resource company focused on responsibly providing metals essential to economic development and the energy transition. Teck has a portfolio of world-class copper and zinc operations across North and South America and an industry-leading copper growth pipeline. We are focused on creating value by advancing responsible growth and ensuring resilience built on a foundation of stakeholder trust. Headquartered in Vancouver, Canada, Teck’s shares are listed on the Toronto Stock Exchange under the symbols TECK.A and TECK.B and the New York Stock Exchange under the symbol TECK. Learn more about Teck at www.teck.com or follow @TeckResources.

Investor Contact:
Edwin Shadeo
Acting Vice President, Investor Relations and Treasurer
604.699.4531
edwin.shadeo@teck.com

Media Contact:
Dale Steeves
Director, External Communications
236.987.7405
dale.steeves@teck.com

• Objective response rate of 72.2% among response-evaluable patients receiving a starting dose of ≥450 mg at 32-week landmark
• Disease control rate of 100% across all response-evaluable patients receiving a starting dose of ≥450 mg, with no disease progression and no treatment discontinuations due to TRAEs
• Data informed FDA-aligned dose and regimen selection for upcoming PEDESTAL Phase 3 registrational trial, with initiation planned in the first half of 2027 and topline results anticipated in 2029
• Company to host investor webcast on Saturday, October 24, 2026, at 18:00 CEST (12:00 p.m. EDT)
  

CAMBRIDGE, Mass., Oct. 24, 2026 (GLOBE NEWSWIRE) — Parabilis Medicines (Nasdaq: PBLS), a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking historically undruggable targets, today announced updated safety and efficacy data for zolucatetide, the first and only direct inhibitor of the β-catenin:TCF interaction, in patients with desmoid tumors. The data were presented today in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2026, taking place October 23–27, 2026, in Madrid, Spain.

The updated results, based on a June 22, 2026, data cutoff, include data from both the dose escalation and dose optimization portions of the ongoing Phase 1/2 trial and reinforce the strong efficacy and favorable safety and tolerability profile observed with zolucatetide. Among response-evaluable patients who began treatment at a starting dose of ≥450 mg, zolucatetide demonstrated an objective response rate (ORR) of 72.2% (13/18) in a 32-week landmark analysis. A disease control rate (DCR) of 100% was observed across all 46 response-evaluable patients who received a starting dose of ≥450 mg, with no disease progression.

Data from a three-arm randomized dose optimization trial supported selection of a 450 mg weekly induction regimen administered for four cycles, followed by 300 mg every two weeks for long-term maintenance. Following productive end-of-Phase 2 discussions, Parabilis has reached alignment with the U.S. Food and Drug Administration (FDA) on the selected dose and regimen, on the use of a placebo-controlled study design, and on progression-free survival (PFS) as the primary endpoint for registrational development.

Parabilis plans to initiate the randomized, double-blind PEDESTAL Phase 3 trial (Phase 3 Evaluation of DESmoid Tumor Activity with zoLucatetide) in the first half of 2027, with topline results anticipated in 2029.

“Desmoid tumors are chronic and life-altering for patients, often affecting people at a young age, and patients need treatments that can deliver rapid, deep and durable tumor responses with a tolerability profile suited for long-term treatment,” said Mathai Mammen, M.D., Ph.D., Chairman, CEO and President of Parabilis Medicines. “We designed zolucatetide to directly inhibit β-catenin:TCF, a historically undruggable target at the heart of the biology driving these tumors. The depth and consistency of responses we are seeing, together with the favorable safety and tolerability profile observed to date, reinforce our conviction that zolucatetide has the potential to deliver a truly differentiated medicine and meaningfully expand the number of patients who can benefit from treatment. We are very pleased with the clarity of the FDA’s feedback on our registrational development strategy, and with our Phase 3 regimen selected, we are moving with urgency to bring this medicine to patients.”

Updated Phase 1/2 Results
As of the June 22, 2026, data cutoff, 76 patients with desmoid tumors had been enrolled and treated across all dose levels in the dose escalation and dose optimization portions of the trial. Median age was 37 years (range 19–80), and 69.7% of patients were female. The population included both patients who had previously been treated with and failed gamma-secretase inhibitors (GSIs) and patients naive to GSIs.

A total of 48 patients began treatment at a starting induction dose of ≥450 mg, prior to down-dosing for maintenance. Two patients were started at 900 mg, but had an average dose of 400–500 mg over the first four months of treatment. Of these 48 patients, 46 were response-evaluable, and 18 had scans at 32 weeks. Median time on treatment for this cohort was 4.7 months (range 0.5–22.3), reflecting recent enrollment of a substantial portion of the cohort.

Efficacy

• ORR per RECIST 1.1 was 72.2% (13/18) among all patients evaluable at the 32-week landmark
• A disease control rate (DCR) of 100% was observed across all 46 response-evaluable patients
• Responses were observed irrespective of prior gamma-secretase inhibitor (GSI) exposure or CTNNB1 or APC mutation status
• No evidence of disease progression or resistance

Safety

• Zolucatetide continued to demonstrate a favorable safety and tolerability profile at the selected doses for Phase 3 registrational development
• Treatment-related adverse events (TRAEs) were predominantly low-grade; the most commonly reported TRAEs were fatigue, alopecia and nausea
• No patients discontinued treatment due to TRAEs
• Not associated with ovarian toxicity or high-grade gastrointestinal or skin toxicities commonly reported with GSIs

“The early clinical results with zolucatetide are encouraging, particularly the magnitude and apparent rapidity of tumor responses observed to date,” said Mrinal Gounder, M.D., Sarcoma Medical Oncologist and Early Drug Development Specialist at Memorial Sloan Kettering Cancer Center, and presenting author of the study. “Desmoid tumors can impose a substantial physical and emotional burden on patients, and therapies capable of achieving meaningful tumor shrinkage while maintaining acceptable tolerability remain an important clinical goal. These findings support further investigation of zolucatetide in the planned Phase 3 trial.”

The Phase 1/2 trial is ongoing in patients with desmoid tumors and a range of other tumor types driven by alterations in the Wnt/β-catenin pathway, and follow-up is continuing. Zolucatetide has received Fast Track and Orphan Drug Designations from the FDA for the treatment of desmoid tumors.

These findings provide further clinical validation of the potential of the Company’s Helicon™ platform to unlock disease-driving targets historically considered undruggable.

Investor Webcast
Parabilis will host an investor webcast on Saturday, October 24, 2026, at 18:00 CEST (12:00 p.m. EDT) to discuss the updated zolucatetide data that will be presented at ESMO Congress 2026. The webcast will be available on the Investors section of the Parabilis website at https://investors.parabilismed.com. Both the presentation and a replay of the webcast will be available following the event.

About Desmoid Tumors
Desmoid tumors are locally invasive soft-tissue tumors that arise in connective tissues and can be aggressive and recurrent, often causing chronic pain, limited mobility, disfigurement and organ dysfunction. An estimated 30,000 people in the U.S. alone are living with desmoid tumors, including approximately 11,000 who are actively managed, with significant unmet need globally as well. Desmoid tumors typically present in young adults, predominantly females, with many patients requiring prolonged or intermittent treatment. Wnt/β-catenin pathway-activating mutations are the causal driver of desmoid tumors, yet no approved therapies directly target this underlying biology of the disease.

About Zolucatetide
Zolucatetide is an investigational first-in-class and first and only direct inhibitor of the interaction between β-catenin and the T-cell factor (TCF) family of transcription factors, a genetically validated driver of numerous cancers and other serious diseases that has long been considered undruggable. Developed using Parabilis’ Helicon™ peptide platform, zolucatetide is designed to prevent the activation of disease-driving genes by directly targeting β-catenin:TCF, a key downstream node in the Wnt/β-catenin pathway. This approach has the potential to address aberrant Wnt/β-catenin signaling regardless of the upstream APC or β-catenin mutations driving pathway activation, potentially overcoming a key limitation of approaches targeting earlier steps in the pathway.

Zolucatetide is currently being evaluated in an ongoing Phase 1/2 clinical trial (NCT05919264) across a range of indications, including desmoid tumors, familial adenomatous polyposis (FAP), adamantinomatous craniopharyngioma (ACP), hepatocellular carcinoma (HCC) and additional Wnt-driven tumor types.

About Parabilis Medicines
Parabilis Medicines (Nasdaq: PBLS) is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking biologically important targets long considered undruggable. The Company has pioneered a new class of alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that have historically been beyond the reach of conventional medicines. The Company’s lead investigational medicine, zolucatetide, is the first and only direct inhibitor of the β-catenin:TCF interaction, a central node in the Wnt/β-catenin pathway that has eluded drug developers for decades. Zolucatetide is being evaluated in the clinic across multiple Wnt/β-catenin-driven diseases, including desmoid tumors, familial adenomatous polyposis (FAP), adamantinomatous craniopharyngioma (ACP), hepatocellular carcinoma (HCC) and a range of other rare and common solid tumor indications. Beyond zolucatetide, Parabilis is pursuing a follow-on β-catenin degrader program and advancing additional Helicon-based programs focused on other challenging targets, including ERG and allosteric AR^ON in prostate cancer, where we believe our medicines could have life-altering impact. For more information, visit www.parabilismed.com or follow us on LinkedIn.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. These include, without limitation, statements regarding: the design, initiation, enrollment and timing of the planned PEDESTAL Phase 3 trial of zolucatetide in desmoid tumors, including expected initiation in the first half of 2027 and topline results anticipated in 2029; our interactions with the U.S. Food and Drug Administration (FDA) regarding the dose and regimen, trial design and primary endpoint for registrational development; the ongoing Phase 1/2 trial of zolucatetide, including continued follow-up of participants; the potential therapeutic benefit, safety, tolerability and differentiation of zolucatetide, and its potential to expand the number of patients who may benefit from treatment; the potential benefits of Fast Track and Orphan Drug Designations; the development of zolucatetide in additional indications, including FAP, ACP, HCC and other Wnt-driven tumors; our strategy, plans and objectives.

Words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Forward-looking statements are based on management’s current expectations and assumptions. They are subject to risks, uncertainties and other important factors that could cause actual results to differ materially from those expressed or implied. These include, among others: the Phase 1/2 data described in this press release are interim, based on a June 22, 2026 data cutoff, and involve a limited number of patients, and may change as patients continue to be followed. Results of earlier clinical trials may not be predictive of results of later trials, including the PEDESTAL trial; FDA feedback on our development plans is not binding, may change and may not be sufficient to support marketing approval; the risk of delays or difficulties in initiating or enrolling clinical trials; the risk of unexpected adverse events or safety findings as more patients are treated for longer periods; Fast Track and Orphan Drug Designations may not lead to faster development, regulatory review or approval.

For a further discussion of these and other risks, see “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, as well as our subsequent filings with the Securities and Exchange Commission. Any forward-looking statement in this press release speaks only as of the date of this press release. Except as required by law, we undertake no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Disclosure: Dr. Gounder has financial interests related to Parabilis Medicines.

Contacts

Media Contact
Jessica Freifeld
media@parabilismed.com

Investor Contact
Tom Kotarakos
investors@parabilismed.com

• In 24 heavily pre-treated patients with advanced primary cutaneous melanoma whose cancer had progressed after multiple prior lines of therapy including anti-PD-1 therapy, data continue to show an acceptable safety profile and early signals of efficacy
• 41.7% (10/24) overall response rate (ORR) per RECIST 1.1, including 4 complete responses
• 75% (18/24) disease control rate (DCR)
• 17.8 months median Overall Survival
• Exploratory analysis in a subset of patients (n=8) identified IL-1β, a cytokine linked to treatment-induced anti-tumor immunity, as the most increased plasma cytokine after treatment
• Investigators concluded that these preliminary findings warrant further evaluation in randomized clinical trials for patients with primary cutaneous melanoma naïve or refractory to anti-PD-1

Data presented at the 2026 Congress of the European Society for Medical Oncology

PARIS and CAMBRIDGE, Mass., Oct. 24, 2026 (GLOBE NEWSWIRE) — NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the “Company”), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, today announced updated results from patients with anti-PD-1-resistant advanced primary cutaneous melanoma treated in the ongoing Phase 1 Study 1100. The study evaluates JNJ-1900 (NBTXR3), which works in the presence of radiotherapy, followed by an immune checkpoint inhibitor (nivolumab or pembrolizumab) in patients with advanced solid tumors. The data were presented by Jason Chan, MD, Associate Professor, Department of Radiation Oncology, UCSF Helen Diller Family Comprehensive Cancer Center, in a poster session on Saturday, October 24, 2026, at the 2026 Annual Meeting of the European Society for Medical Oncology (“ESMO”) in Madrid, Spain.

ABSTRACT #3956: Safety and Anti-Tumor Activity of NBTXR3/SBRT with Immune Checkpoint Inhibitors in Anti-PD-1 Resistant Melanoma: Results from a Phase I Dose Expansion

^{J. Chan, J. Lee, A. Lam, A. Daud, F. Collichio, H. Yu, P. Mody, J. Weiss, S. Moschos, S. Powell, S. Peck, M. Lohr, E. Redstone, Z. Li, W. Smith, A. Juloori, R. Gineste, D. Rolando, A. Rosenberg and C. Shen. UCSF Helen Diller Family Comprehensive Cancer Center; UNC Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill; Sanford Cancer Center; St Luke’s University Hospital; The University of Chicago; Nanobiotix}

Patients with advanced anti-PD-1 resistant primary cutaneous melanoma whose disease has progressed after multiple prior lines of therapy have a poor prognosis; published series report a median progression-free survival of approximately three months¹ and a median overall survival of approximately one year² in this setting. Melanoma has historically been considered radioresistant, and higher radiation doses are often limited by exposure of the surrounding healthy tissue.

“Patients whose melanoma has progressed on anti-PD-1 therapy, and often on several other immunotherapies as well, have limited options left,” said Jason Chan, MD, Associate Professor, Department of Radiation Oncology, UCSF Helen Diller Family Comprehensive Cancer Center “In this study, a single injection followed by a short course of stereotactic radiotherapy was feasible across a wide range of tumor sizes and locations, and we saw responses in lesions that were injected and in lesions that were not. The observed increase in IL-1β suggests treatment-related immune activation that warrants further investigation. These are early data from a single-arm study, and they support testing the approach in a randomized trial.”

All 24 heavily pre-treated patients had advanced primary cutaneous melanoma resistant to anti-PD-1; 14 had stage IV disease. Most had received other immunotherapies before enrolling, including anti-CTLA-4 (50%), anti-LAG-3 (33.3%) and T-VEC (25%), and 87.5% had received immunotherapy as their most recent therapy. Patients received a one-time intratumoral injection of JNJ-1900 (NBTXR3) at the recommended Phase 2 dose (33% of gross tumor volume), followed by stereotactic body radiotherapy (“SBRT”) to the injected lesion and then nivolumab or pembrolizumab. Investigators observed an acceptable safety profile and early signals of efficacy.

Safety and Feasibility

Treatment consisting of a single intratumoral JNJ-1900 (NBTXR3) injection, followed by a short course of radiotherapy was feasible across a wide range of melanoma lesions, providing a minimally invasive treatment approach with an acceptable safety profile. No new safety signals have been observed.

Preliminary Efficacy

An Overall Response Rate (ORR) of 41.7% (10/24 patients) was observed. Responses were observed in both injected (ORR 45.8%; 11/24 evaluable patients) and non-injected lesions (ORR 30.0%; 3/10 evaluable patients).

Median Progression Free Survival (PFS) was 6.9 months, while median Overall Survival reached 17.8 months.

Exploratory Immune Profiling

In an exploratory analysis of plasma samples from a subset of patients (n=8), IL-1β showed the largest increase from baseline among the cytokines evaluated. Published research has linked IL-1β to treatment-induced anti-tumor immunity through its role in connecting innate immune activation to the priming of tumor-specific CD8+ T cells.³

“This updated analysis, with more patients and longer follow-up, builds on the first data we reported with consistent safety and an improvement in Overall Survival relative to the first data reported,” said Louis Kayitalire, MD, Chief Medical Officer of Nanobiotix. “Responses were again seen in patients whose disease had progressed after multiple prior therapies, including in lesions that were not injected. Together with the exploratory cytokine data, these findings warrant further evaluation of JNJ-1900 (NBTXR3) followed by anti-PD-1 therapy in patients with anti-PD-1-resistant melanoma.”

Overall, the acceptable safety profile and early efficacy observed by investigators in these preliminary findings provide promising signals of activity and warrant further evaluation in larger randomized trials.

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles administered via one-time intratumoral injection and designed to work in the presenced of radiotherapy. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when in the presence of radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Proof-of-concept was demonstrated in a randomized Phase 2/3 soft tissue sarcoma study sponsored by Nanobiotix in 2018.

JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations.

In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy.

In 2023, Nanobiotix announced a license agreement for the global development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company. Studies being led by Johnson & Johnson include NANORAY-312 (NCT04892173), a global, randomized Phase 3 study in platinum-based chemotherapy-ineligible, locally advanced head and neck squamous cell cancers; LUMIRAY (NCT07219212), a global, phase 1b, open-label study in locally advanced head and neck squamous cell cancers; and CONVERGE (NCT06667908), a phase 2, randomized, open-label, active-controlled study in locally advanced and unresectable Stage III non-small cell lung cancer (NSCLC).

About NANOBIOTIX

Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.

Incorporated in 2003, Nanobiotix is headquartered in Paris, France and is listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. The Company has subsidiaries in Cambridge, Massachusetts (United States) amongst other locations.

Nanobiotix is the owner of more than 30 umbrella patents associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system.

For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter

Disclaimer

This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the use of proceed therefrom, and the period of time through which the Company’s anticipates its financial resources will be adequate to support operations. Words such as “expects”, “intends”, “can”, “could”, “may”, “might”, “plan”, “potential”, “should” and “will” or the negative of these and similar expressions are intended to identify forward-looking statements. These forward-looking statements which are based on the Company’ management’s current expectations and assumptions and on information currently available to management. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements, including risks related to Nanobiotix’s business and financial performance, which include the risk that assumptions underlying the Company’s cash runway projections are not realized. Further information on the risk factors that may affect company business and financial performance is included in Nanobiotix’s Annual Report on Form 20-F filed with the SEC on March 31, 2026 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2025 universal registration document filed with the AMF on March 31, 2026 under “chapter 1.5 Risk Factors”, and subsequent filings Nanobiotix makes with the SEC and AMF from time to time, including the Half-Year Report at June 30, 2026, which are available on the SEC’s website at www.sec.gov and on the AMF’s website at www.amf.org, The forward-looking statements included in this press release speak only as of the date of this press release, and except as required by law, Nanobiotix assumes no obligation to update these forward-looking statements publicly.

Nanobiotix
Communications Department Brandon Owens VP, Communications contact@nanobiotix.com	Investor Relations Department Joanne Choi VP, Investor Relations (US) joanne.choi@nanobiotix.com  Ricky Bhajun Director, Investor Relations (EU) investors@nanobiotix.com
Media Relations
France – HARDY Caroline Hardy +33 06 70 33 49 50 carolinehardy@outlook.fr	Global – uncapped Becky Lauer +1 (646) 286-0057 uncappednanobiotix@uncappedcommunications.com

________________ 

_{¹Patrinely JR Jr., Cancer. 2020
²Nordstrom BL, Future Oncol. 18:1343-1355, 2022
³Ghiringhelli et al. Nat Med. 15(10):1170-8, 2009}

Attachment

• PR_Study 1100 Melanoma Data ESMO 2026

Media Release

COPENHAGEN, Denmark and WILMINGTON, Del.; October 24, 2026

• Phase 1/2 study will evaluate petosemtamab plus INCB161734 and standard-of-care chemotherapy in first-line KRAS G12D-mutated metastatic colorectal cancer (mCRC)

Genmab A/S (Nasdaq: GMAB) and Incyte (Nasdaq: INCY) today announced a clinical trial collaboration to evaluate petosemtamab, Genmab’s investigational IgG1-bispecific antibody targeting the epidermal growth factor receptor (EGFR) and leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5), in combination with INCB161734, Incyte’s investigational, potent and selective KRAS G12D inhibitor, and standard-of-care chemotherapy as a first-line treatment for patients with metastatic colorectal cancer harboring a KRAS G12D mutation, an area with substantial unmet medical need.

“This collaboration supports our broader development strategy for petosemtamab as we explore its potential across treatment settings and in novel combinations,” said Judith Klimovsky, M.D., Executive Vice President and Chief Development Officer, Genmab. “Partnering with Incyte enables us to evaluate this investigational combination in patients with KRAS G12D-mutated metastatic colorectal cancer, reflecting our commitment to research collaborations aimed at expanding potential treatment options for more patients.”

“Metastatic colorectal cancer remains difficult-to-treat, underscoring the importance of evaluating novel combinations grounded in complementary scientific approaches with the potential to enhance efficacy,” said Pablo J. Cagnoni, M.D., President, Incyte and Global Head of Research and Development. “Our collaboration with Genmab will explore the potential of combining KRAS G12D inhibition with LGR5-targeted EGFR inhibition and standard-of-care chemotherapy, with the goal of advancing a new first-line treatment approach for patients with metastatic colorectal cancer.”

Under the collaboration, Genmab will conduct the Phase 1/2 study evaluating petosemtamab in combination with INCB161734 and standard-of-care chemotherapy in patients with KRAS G12D-mutated mCRC in the first-line setting. Incyte will co-fund the study and provide clinical supply of INCB161734.

KRAS mutations occur in approximately 40% of colorectal cancers, with G12D being the most common KRAS mutation. These cancers are associated with poor prognosis, underscoring the need for new treatment approaches. The collaboration reflects a shared focus on investigating whether agents with distinct and potentially complementary mechanisms, combined with standard-of-care chemotherapy, may offer a path toward a new treatment option for patients with KRAS G12D-mutated metastatic colorectal cancer.

About Petosemtamab (GEN1158)
Petosemtamab is an investigational human IgG1-based bispecific antibody targeting the EGFR and the LGR5 and designed to support multiple anti-tumor mechanisms. It inhibits EGFR-mediated signaling by engaging a unique site on the receptor to prevent ligand binding. In addition, petosemtamab triggers EGFR degradation in cancer stem-like cells expressing both EGFR and LGR5. Petosemtamab is also engineered to enhance innate immune-mediated activity through interactions with macrophages and natural killer cells. It is currently being investigated in head and neck squamous cell carcinoma (HNSCC) and other solid tumors, including colorectal cancer (CRC). Petosemtamab is being evaluated in combination with chemotherapy in two Phase 3 trials in first- and second-line RAS/BRAF wild-type metastatic CRC. Please visit https://clinicaltrials.gov/ for more information.

About INCB161734
INCB161734 is an investigational, novel, selective and orally bioavailable small molecule ON/OFF KRAS G12D inhibitor. KRAS is one of the most frequently altered oncogenic drivers across solid tumors, and the KRAS G12D mutation is among the most common KRAS alterations, occurring in approximately 40% of pancreatic ductal adenocarcinoma (PDAC) cases and approximately 15% of colorectal cancer (CRC) cases.

INCB161734 is being evaluated in the global Phase 3 DAWN-303 (NCT07522073) study which is currently enrolling patients with previously untreated KRAS G12D-mutated pancreatic ductal adenocarcinoma (PDAC) to further evaluate the efficacy and safety of INCB161734 in combination with standard-of-care (SoC) chemotherapy.

INCB161734 is also being evaluated as a monotherapy and in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel [GEMNabP] or modified FOLFIRINOX [mFOLFIRINOX]), in an ongoing open-label Phase 1 study across KRAS G12D-mutated solid tumors (NCT06179160).

About Genmab 
Genmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, antibody–drug conjugates (ADCs), immune-modulating antibodies and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com or follow us on LinkedIn, X, Facebook and Instagram.

About Incyte®
Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation & Autoimmunity.

To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.

Genmab Contacts

Media:        
Jyoti Sharma, Director, Global Communications & Corporate Affairs
T: +1 609 480 9844; E: jysh@genmab.com

Investor Relations:
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com

Incyte Contacts

Media:                                                         
media@incyte.com
                
Investors:
ir@incyte.com

Genmab Forward-Looking Statements
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Incyte Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding Incyte’s clinical trial collaboration with Genmab; the design, initiation, timing, conduct, sponsorship and funding of the planned studies; the potential presented by INCB161734, petosemtamab and the combination of these investigational therapies with standard-of-care chemotherapy; the potential for the combination to provide a new treatment option for patients with first-line KRAS G12D-mutated metastatic colorectal cancer; expectations regarding the initiation, timing, progress and results of ongoing and planned clinical trials for INCB161734; whether or when INCB161734, petosemtamab or any combination regimen will be approved or commercially available for use in humans anywhere in the world; Incyte’s oncology portfolio and development strategy; and Incyte’s aspirations and goals as set forth under the heading “About Incyte.”

Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including whether preclinical or early clinical results will be replicated in later-stage or larger clinical trials; the sufficiency of clinical trial data to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and to enroll subjects in accordance with planned schedules; changes in clinical development plans; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and regulatory approval; the efficacy or safety of Incyte’s products and product candidates; Incyte’s ability to successfully develop and commercialize its product candidates; Incyte’s reliance on third parties and collaboration partners, including with respect to the planned studies described herein; the availability and effectiveness of competing treatments; Incyte’s ability to obtain and maintain protection of intellectual property for its products and technology; greater than expected expenses, including expenses relating to clinical development, litigation or strategic activities; and those risks and uncertainties discussed in greater detail in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2025 and its quarterly report on Form 10-Q for the quarter ended June 30, 2026. Incyte disclaims any intent or obligation to update these forward-looking statements.

Attachment

• 102426 MR13 Genmab Incyte CRC

• As published in the Journal of Clinical Oncology (JCO) and presented at ESMO, COMPANION-002 met its primary endpoint of ORR and key secondary endpoint of PFS, with a 56% reduction in the risk of disease progression or death.
• Responses were durable, with a median duration of response (DOR) of 4.9 months, and disease control rate (DCR) was also significantly improved (62.2% vs. 36.8%).
• A new, post hoc analysis of overall survival (OS) included in the JCO publication uses the Two-Stage Estimation, an established method for adjusting for crossover, and demonstrates an OS hazard ratio of 0.85 (95% CI, 0.59–1.26; p=0.53).
• Safety profile was consistent with prior tovecimig studies and the anti-VEGF class, with no new safety signals identified.

BOSTON, Oct. 24, 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 announced the publication of results from the positive Phase 2/3 COMPANION-002 study of tovecimig in combination with paclitaxel in patients with previously treated, advanced biliary tract cancer (BTC) in the Journal of Clinical Oncology (JCO). The results are also being presented today by Nilofer S. Azad, M.D., Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, at the 2026 European Society for Medical Oncology (ESMO) Congress in Madrid, Spain. The full publication is available via open access at https://ascopubs.org/toc/jco/0/ja.

COMPANION-002 is a randomized Phase 2/3 study that evaluated tovecimig plus paclitaxel versus paclitaxel alone in 168 patients with advanced BTC who had received one prior therapy. As previously reported, and now published following peer review, the study met its primary endpoint, with tovecimig plus paclitaxel demonstrating a statistically significant improvement in ORR of 18.0% vs. 5.3% with paclitaxel alone (p=0.0228) evaluated by blinded independent central review (BICR). The study also met its key secondary endpoint of PFS with a median PFS of 4.7 vs. 2.6 months (HR=0.44, p<0.0001), representing a 56% reduction in the risk of disease progression or death.

Key findings from COMPANION-002 include:

• Duration of response and disease control: Responses with tovecimig plus paclitaxel lasted a median of 4.9 months. The disease control rate, which includes patients whose cancer responded or remained stable, significantly improved at 62.2% vs. 36.8% with paclitaxel alone (p=0.0018).
• Intrahepatic cholangiocarcinoma subgroup: Patients with intrahepatic cholangiocarcinoma (cancer of the bile ducts inside the liver), a prespecified subgroup, made up more than half of the study population (92 of 168). In these patients, results were consistent with the overall study population, with an ORR of 15.3% vs. 0% (p=0.0258) and median PFS of 5.1 vs. 3.0 months (HR=0.32).
• Overall survival (OS) and crossover-adjusted analysis: Patients in the paclitaxel arm could cross over to tovecimig plus paclitaxel arm after BICR-confirmed progression. 31 of 57 (54%) patients crossed over, resulting in 85% of all patients in the study (142 of 168) ultimately receiving tovecimig. The intent-to-treat OS analysis was confounded by the high rate of crossover and no statistically significant difference in OS was observed. To estimate the treatment effect if crossover had not occurred, the JCO publication includes a post hoc exploratory analysis using the Two-Stage Estimation, an established method for adjusting for crossover, in which the OS hazard ratio was 0.85 (95% CI, 0.59–1.26; p=0.53).
• Outcomes in crossover patients: Among the 31 patients who crossed over, median PFS after the addition of tovecimig to paclitaxel, a prespecified secondary endpoint, was 3.5 months, compared with 1.9 months during their initial treatment with paclitaxel alone (HR=0.40, p=0.0035). In a post hoc exploratory analysis, these patients who crossed over to receive tovecimig had a median OS of 12.8 months, compared with 6.1 months for control-arm patients who did not cross over (HR=0.54, p=0.04), even though crossover patients had progressed more quickly on initial paclitaxel treatment. These crossover comparisons were not randomized and are exploratory.
• Safety: The safety profile was generally manageable and consistent with prior tovecimig studies and the anti-VEGF class, with no new safety signals identified. The most common treatment-emergent adverse events (TEAEs) in the combination arm were hypertension (69%) and fatigue (67%). Grade 3 or higher TEAEs occurred in 93.5% of patients in the combination arm and 64.2% of patients who received paclitaxel alone. TEAEs leading to overall treatment discontinuation occurred in 27.8% and 11.3%, respectively, and were mostly consistent with known anti-angiogenic and chemotherapy toxicities. No hypertensive crises or unexpected severe cardiovascular toxicities were observed. TEAEs leading to death occurred in 5.6% and 1.9% of patients, respectively.

“COMPANION-002 is an important, randomized study in patients with previously treated, advanced biliary tract cancer,” said Dr. Azad. “The significant improvements in response rate and progression-free survival, together with the durability of responses and disease control, are encouraging for patients in this setting. We also saw activity in patients who switched to tovecimig after their disease progressed on paclitaxel alone, which is notable in a setting where disease often progresses quickly.”

“Publication of the COMPANION-002 results in the Journal of Clinical Oncology following independent peer review is a significant milestone for patients with BTC,” said Thomas Schuetz, M.D., Ph.D., Chief Executive Officer of Compass. “These data, including the new two-stage estimation adjusting for the crossover impact on overall survival, strengthen our conviction that tovecimig has the potential to make a meaningful difference for patients with previously treated, advanced biliary tract cancer who have few treatment options. We are determined to bring tovecimig to these patients and will continue working with the FDA toward that goal.”

Additional analyses from COMPANION-002, including patient-reported quality of life and translational research, are ongoing and will be reported separately.

About Tovecimig
Tovecimig is an investigational DLL4 x VEGF-A bispecific antibody designed to block two angiogenic pathways simultaneously, representing a first-in-class approach to disrupting tumor angiogenesis. In COMPANION-002, tovecimig was evaluated in combination with paclitaxel in patients with previously treated, advanced biliary tract cancer. Tovecimig has received Fast Track and Orphan Drug Designation from the U.S. Food and Drug Administration. Tovecimig remains investigational and has not been approved by the FDA.

About Biliary Tract Cancer
BTC is an aggressive, life-threatening cancer estimated to affect approximately 26,500 patients annually in the United States. For the vast majority of patients with BTC whose tumors do not harbor an actionable mutation with an approved targeted therapy, there is currently no FDA-approved treatment in the second-line setting. The therapies most commonly used in this setting, which are not labeled or approved by the FDA for the treatment of patients with BTC, generally have an ORR of approximately 5% or less.

About COMPANION-002
COMPANION-002 (NCT05506943) is a randomized, controlled Phase 2/3 study of tovecimig in patients with unresectable advanced, metastatic or recurrent BTC who received one prior systemic chemotherapy regimen. The study randomized 168 patients 2:1 to tovecimig plus paclitaxel (n=111) or paclitaxel alone (n=57). The primary endpoint was ORR by blinded independent central review; secondary endpoints included PFS, OS and duration of response.

About Compass Therapeutics
Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company dedicated to transforming the standard of care for patients with cancer through the discovery and development of innovative antibody-based therapeutics. The company leverages deep expertise in tumor biology and proprietary antibody engineering technologies to develop differentiated therapies that target the intersection of angiogenesis, immune activation, and tumor-driven immunosuppression. Compass has a robust pipeline of novel product candidates in clinical development designed to address significant unmet needs and improve outcomes for patients with cancer. The Company was founded in 2014 and is headquartered in Boston, Massachusetts. For more information, visit the Compass Therapeutics website at https://www.compasstherapeutics.com.

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 www.sec.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

• As published in the Journal of Clinical Oncology (JCO) and presented at ESMO, COMPANION-002 met its primary endpoint of ORR and key secondary endpoint of PFS, with a 56% reduction in the risk of disease progression or death.
• Responses were durable, with a median duration of response (DOR) of 4.9 months, and disease control rate (DCR) was also significantly improved (62.2% vs. 36.8%).
• A new, post hoc analysis of overall survival (OS) included in the JCO publication uses the Two-Stage Estimation, an established method for adjusting for crossover, and demonstrates an OS hazard ratio of 0.85 (95% CI, 0.59–1.26; p=0.53).
• Safety profile was consistent with prior tovecimig studies and the anti-VEGF class, with no new safety signals identified.

BOSTON, Oct. 24, 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 announced the publication of results from the positive Phase 2/3 COMPANION-002 study of tovecimig in combination with paclitaxel in patients with previously treated, advanced biliary tract cancer (BTC) in the Journal of Clinical Oncology (JCO). The results are also being presented today by Nilofer S. Azad, M.D., Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, at the 2026 European Society for Medical Oncology (ESMO) Congress in Madrid, Spain. The full publication is available via open access at https://ascopubs.org/toc/jco/0/ja.

COMPANION-002 is a randomized Phase 2/3 study that evaluated tovecimig plus paclitaxel versus paclitaxel alone in 168 patients with advanced BTC who had received one prior therapy. As previously reported, and now published following peer review, the study met its primary endpoint, with tovecimig plus paclitaxel demonstrating a statistically significant improvement in ORR of 18.0% vs. 5.3% with paclitaxel alone (p=0.0228) evaluated by blinded independent central review (BICR). The study also met its key secondary endpoint of PFS with a median PFS of 4.7 vs. 2.6 months (HR=0.44, p<0.0001), representing a 56% reduction in the risk of disease progression or death.

Key findings from COMPANION-002 include:

• Duration of response and disease control: Responses with tovecimig plus paclitaxel lasted a median of 4.9 months. The disease control rate, which includes patients whose cancer responded or remained stable, significantly improved at 62.2% vs. 36.8% with paclitaxel alone (p=0.0018).
• Intrahepatic cholangiocarcinoma subgroup: Patients with intrahepatic cholangiocarcinoma (cancer of the bile ducts inside the liver), a prespecified subgroup, made up more than half of the study population (92 of 168). In these patients, results were consistent with the overall study population, with an ORR of 15.3% vs. 0% (p=0.0258) and median PFS of 5.1 vs. 3.0 months (HR=0.32).
• Overall survival (OS) and crossover-adjusted analysis: Patients in the paclitaxel arm could cross over to tovecimig plus paclitaxel arm after BICR-confirmed progression. 31 of 57 (54%) patients crossed over, resulting in 85% of all patients in the study (142 of 168) ultimately receiving tovecimig. The intent-to-treat OS analysis was confounded by the high rate of crossover and no statistically significant difference in OS was observed. To estimate the treatment effect if crossover had not occurred, the JCO publication includes a post hoc exploratory analysis using the Two-Stage Estimation, an established method for adjusting for crossover, in which the OS hazard ratio was 0.85 (95% CI, 0.59–1.26; p=0.53).
• Outcomes in crossover patients: Among the 31 patients who crossed over, median PFS after the addition of tovecimig to paclitaxel, a prespecified secondary endpoint, was 3.5 months, compared with 1.9 months during their initial treatment with paclitaxel alone (HR=0.40, p=0.0035). In a post hoc exploratory analysis, these patients who crossed over to receive tovecimig had a median OS of 12.8 months, compared with 6.1 months for control-arm patients who did not cross over (HR=0.54, p=0.04), even though crossover patients had progressed more quickly on initial paclitaxel treatment. These crossover comparisons were not randomized and are exploratory.
• Safety: The safety profile was generally manageable and consistent with prior tovecimig studies and the anti-VEGF class, with no new safety signals identified. The most common treatment-emergent adverse events (TEAEs) in the combination arm were hypertension (69%) and fatigue (67%). Grade 3 or higher TEAEs occurred in 93.5% of patients in the combination arm and 64.2% of patients who received paclitaxel alone. TEAEs leading to overall treatment discontinuation occurred in 27.8% and 11.3%, respectively, and were mostly consistent with known anti-angiogenic and chemotherapy toxicities. No hypertensive crises or unexpected severe cardiovascular toxicities were observed. TEAEs leading to death occurred in 5.6% and 1.9% of patients, respectively.

“COMPANION-002 is an important, randomized study in patients with previously treated, advanced biliary tract cancer,” said Dr. Azad. “The significant improvements in response rate and progression-free survival, together with the durability of responses and disease control, are encouraging for patients in this setting. We also saw activity in patients who switched to tovecimig after their disease progressed on paclitaxel alone, which is notable in a setting where disease often progresses quickly.”

“Publication of the COMPANION-002 results in the Journal of Clinical Oncology following independent peer review is a significant milestone for patients with BTC,” said Thomas Schuetz, M.D., Ph.D., Chief Executive Officer of Compass. “These data, including the new two-stage estimation adjusting for the crossover impact on overall survival, strengthen our conviction that tovecimig has the potential to make a meaningful difference for patients with previously treated, advanced biliary tract cancer who have few treatment options. We are determined to bring tovecimig to these patients and will continue working with the FDA toward that goal.”

Additional analyses from COMPANION-002, including patient-reported quality of life and translational research, are ongoing and will be reported separately.

About Tovecimig
Tovecimig is an investigational DLL4 x VEGF-A bispecific antibody designed to block two angiogenic pathways simultaneously, representing a first-in-class approach to disrupting tumor angiogenesis. In COMPANION-002, tovecimig was evaluated in combination with paclitaxel in patients with previously treated, advanced biliary tract cancer. Tovecimig has received Fast Track and Orphan Drug Designation from the U.S. Food and Drug Administration. Tovecimig remains investigational and has not been approved by the FDA.

About Biliary Tract Cancer
BTC is an aggressive, life-threatening cancer estimated to affect approximately 26,500 patients annually in the United States. For the vast majority of patients with BTC whose tumors do not harbor an actionable mutation with an approved targeted therapy, there is currently no FDA-approved treatment in the second-line setting. The therapies most commonly used in this setting, which are not labeled or approved by the FDA for the treatment of patients with BTC, generally have an ORR of approximately 5% or less.

About COMPANION-002
COMPANION-002 (NCT05506943) is a randomized, controlled Phase 2/3 study of tovecimig in patients with unresectable advanced, metastatic or recurrent BTC who received one prior systemic chemotherapy regimen. The study randomized 168 patients 2:1 to tovecimig plus paclitaxel (n=111) or paclitaxel alone (n=57). The primary endpoint was ORR by blinded independent central review; secondary endpoints included PFS, OS and duration of response.

About Compass Therapeutics
Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company dedicated to transforming the standard of care for patients with cancer through the discovery and development of innovative antibody-based therapeutics. The company leverages deep expertise in tumor biology and proprietary antibody engineering technologies to develop differentiated therapies that target the intersection of angiogenesis, immune activation, and tumor-driven immunosuppression. Compass has a robust pipeline of novel product candidates in clinical development designed to address significant unmet needs and improve outcomes for patients with cancer. The Company was founded in 2014 and is headquartered in Boston, Massachusetts. For more information, visit the Compass Therapeutics website at https://www.compasstherapeutics.com.

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 www.sec.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

Median PFS was 21.5 months with the gedatolisib triplet and 11.5 months with the gedatolisib doublet versus 9.1 months with alpelisib + fulvestrant in patients who had no liver metastases 

ORR and median duration of response was 59% and 19.4 months for the gedatolisib triplet and 43% and 27.8 months for the gedatolisib doublet, respectively, compared to 33% and 7.5 months for alpelisib + fulvestrant

The discontinuation rate for gedatolisib due to treatment-emergent adverse events was 5% and 4% with the gedatolisib triplet and doublet, respectively, compared to 19% for alpelisib

MINNEAPOLIS, Oct. 24, 2026 (GLOBE NEWSWIRE) — Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced new subgroup analyses from the PIK3CA mutant (“MT”) cohort of the Phase 3 VIKTORIA-1 study evaluating gedatolisib in patients with HR+/HER2- locally advanced or metastatic breast cancer (“ABC”). These data were presented by Dr. Barbara Pistilli, Head of the Breast Cancer Unit, Gustave Roussy, at the European Society of Medical Oncology (ESMO) Congress 2026 today, Saturday, October 24, 2026, at 4:15 a.m. EST/10:15 a.m. CEST during a late breaking rapid oral presentation:

Presentation LBA 16: VIKTORIA-1: Updated results of a randomized, open-label, phase 3 study of gedatolisib (geda) + fulvestrant (fulv) ± palbociclib (palbo) vs standard of care in patients with HR+/HER2- advanced breast cancer (ABC) (Study 2)

Gedatolisib plus fulvestrant with palbociclib (“gedatolisib triplet”) or without palbociclib (“gedatolisib doublet”) significantly improved median progression-free survival (“PFS”) compared with alpelisib plus fulvestrant in HR+/HER2-, PIK3CA mutant ABC patients with and without liver metastases and those with or without visceral metastases:

Subgroup	Gedatolisib Triplet	Gedatolisib Doublet	Alpelisib + Fulvestrant
No Liver metastases, n	77	28	76
mPFS, mos. (95% CI)	21.5 (11.4-NR)	11.5 (9.2-NR)	9.1 (5.6-16.9)
HR (90% CI) vs. control	0.46 (0.30-0.72)	0.71 (0.41-1.25)
p-value	0.0016	0.1627
Liver Metastases, n	78	24	79
mPFS, mos. (95% CI)	9.1 (5.7-11.1)	11.1 (3.7-NR)	4.6 (3.7-5.6)
HR (90% CI) vs. control	0.47 (0.34-0.65)	0.38 (0.23-0.62)
p-value	<0.0001	0.0006
Subgroup	Gedatolisib Triplet	Gedatolisib Doublet	Alpelisib + Fulvestrant
No Visceral Metastases, n	38	13	37
mPFS, mos. (95% CI)	21.5 (9.6 – NR)	NR (1.6-NR)	9.2 (3.9-16.9)
HR (90% CI) vs. control	0.38 (0.21-0.73)	0.40 (0.15-1.1)
p-value	0.0059	0.0703
Visceral Metastases, n	117	39	118
mPFS, mos (95% CI)	9.8 (7.5-12.9)	11.3 (7.4-22.1)	5.6 (4.6-7.2)
HR (90% CI) vs. control	0.52 (0.39-0.70)	0.53 (0.35-0.79)
p-value	<0.0001	0.0042

* NR, not reached

In patients with evaluable disease, the gedatolisib-based regimens induced higher objective response rates (“ORR”) (confirmed and unconfirmed) and longer median durations of response in both the PIK3CA mutant and wild-type cohorts compared to the control:

Study 2 (PIK3CA Mutant Cohort)
Endpoint	Gedatolisib Triplet (n=133)	Gedatolisib Doublet (n=42)	Alpelisib + Fulvestrant (n=127)
Objective Response Rate, n (%)	78 (59%)	18 (43%)	42 (33%)
Median Duration of Response, mos. (95% CI)	19.4 (11.1-25.1)	27.8 (9.2-NR)	7.5 (5.6 – 16.6)
Study 1 (PIK3CA Wild-type Cohort)
	Gedatolisib Triplet (n=124)	Gedatolisib Doublet (n=113)	Fulvestrant (n=105)
Objective Response Rate, n (%)	48 (39%)	38 (34%)	1 (1%)
Median Duration of Response, mos. (95% CI)	19.2 (10.7-NR)	13.8 (9.4-NR)	Not evaluable

In the PIK3CA mutant cohort, the discontinuation rate of gedatolisib due to treatment-emergent adverse events (“TEAEs”) was 5% and 4% for the gedatolisib triplet and doublet, respectively, compared to a 19% discontinuation rate due to TEAEs for alpelisib. Grade 3 stomatitis with gedatolisib was transient. By the second cycle of treatment, less than 3% of patients had Grade 3 stomatitis, and all grade 3 events improved within 1-2 weeks. Discontinuations due to stomatitis for the gedatolisib triplet and gedatolisib doublet were minimal, 1% and 0%, respectively.

“The additional data from Study 2 of VIKTORIA-1 show consistent and significant clinical benefit for important sub-groups of breast cancer patients treated with gedatolisib regimens,” said Igor Gorbachevsky, Chief Medical Officer of Celcuity. “For patients who do not have liver metastases and received the gedatolisib triplet, the median progression-free survival was approximately 21 months, versus approximately 9 months for the alpelisib regimen. This is a particularly important result since patients with no liver metastases represent approximately 60%-70% of all patients treated in this setting.”

“Additionally, the median duration of response was over 19 months for the gedatolisib triplet in both the PIK3CA wild-type cohort, or Study 1, and the PIK3CA mutant cohort, or Study 2, compared to not evaluable for fulvestrant in the PIK3CA wild-type cohort and 7.5 months for alpelisib plus fulvestrant in the PIK3CA mutant cohort. To our knowledge, the gedatolisib triplet in each study demonstrated the longest median duration of response results ever reported for a therapeutic regimen used in the primary analysis for a Phase 3 trial in the second-line HR+/HER2- advanced breast cancer setting.”

VIKTORIA-1 PIK3CA Wild-Type Cohort Comparative Analysis

Dr. Sara Tolaney, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute, presented a comparative analysis of data for the gedatolisib regimens from the PIK3CA wild-type cohort of VIKTORIA-1 and other regimens evaluated in patients with HR+/HER2- advanced breast cancer.

Poster 1873P: Gedatolisib (Ged) vs Other Regimens Post-CDK4/6i and Endocrine Therapy (ET) in PIK3CA Wild-Type (WT) HR+/ HER2- Advanced Breast Cancer (aBC): A Network Meta-Analysis (NMA)

Eight studies were included in this network meta-analysis comparing progression-free survival outcomes in randomized controlled trials of systemic treatments evaluated among patients with HR+/HER2- advanced breast cancer with CDK4/6 inhibitor experience and PIK3CA wild-type tumors. This analysis found that the gedatolisib triplet and doublet each demonstrated statistically significant or numerically superior improvement in PFS and in progression-free survival rate at 6 months relative to the non-gedatolisib regimens evaluated. Of note, the analysis found that patients treated with the gedatolisib triplet and doublet were a statistically significant 2x and 1.5x more likely to survive without disease progression or death compared to imlunestrant plus abemaciclib, respectively.

About HR+/HER2- Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.¹ More than two million breast cancer cases were diagnosed globally in 2022.¹ While survival rates are high for those diagnosed with early breast cancer, only approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.² HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.²

About Celcuity

Celcuity is a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. The company’s first FDA-approved product is REVTORPYK™ (gedatolisib), pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM (PI3K/AKT/mTOR) pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- locally advanced or metastatic breast cancer, supported FDA approval of REVTORPYK for use in patients without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Results for the PIK3CA mutant cohort of VIKTORIA-1 have been released. VIKTORIA-2 is an ongoing Phase 3 clinical trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib plus palbociclib plus fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib plus palbociclib plus letrozole as first-line treatment for patients with endocrine-sensitive HR+/HER2- ABC. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and X.

Forward Looking Statements

This press release contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of the Company’s clinical trials; the Company’s interpretation of clinical trial data; and the Company’s strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “confidence,” “encouraged,” “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management’s current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that the Company’s topline clinical results are based on an ongoing analysis of efficacy and safety data and such data may change following a more comprehensive review of the data related to the clinical trial; and the development of therapies and tools competitive with gedatolisib. In addition, all forward-looking statements are subject to other risks detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as such risks may be updated in its subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

References

1. Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;10.3322/caac.21660.
2. National Cancer Institute. Surveillance, Epidemiology and End Results Program (accessed July 2025). https://seer.cancer.gov/statfacts/html/breast-subtypes.html

Contacts

For Investors: 
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com   
(763) 392-0123
Jodi Sievers, jsievers@celcuity.com
(415) 494-9924

For Media:
Sam Brown LLC
Laura Morgan, lauramorgan@sambrown.com
(951) 333-9110

Median PFS was 21.5 months with the gedatolisib triplet and 11.5 months with the gedatolisib doublet versus 9.1 months with alpelisib + fulvestrant in patients who had no liver metastases 

ORR and median duration of response was 59% and 19.4 months for the gedatolisib triplet and 43% and 27.8 months for the gedatolisib doublet, respectively, compared to 33% and 7.5 months for alpelisib + fulvestrant

The discontinuation rate for gedatolisib due to treatment-emergent adverse events was 5% and 4% with the gedatolisib triplet and doublet, respectively, compared to 19% for alpelisib

MINNEAPOLIS, Oct. 24, 2026 (GLOBE NEWSWIRE) — Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced new subgroup analyses from the PIK3CA mutant (“MT”) cohort of the Phase 3 VIKTORIA-1 study evaluating gedatolisib in patients with HR+/HER2- locally advanced or metastatic breast cancer (“ABC”). These data were presented by Dr. Barbara Pistilli, Head of the Breast Cancer Unit, Gustave Roussy, at the European Society of Medical Oncology (ESMO) Congress 2026 today, Saturday, October 24, 2026, at 4:15 a.m. EST/10:15 a.m. CEST during a late breaking rapid oral presentation:

Presentation LBA 16: VIKTORIA-1: Updated results of a randomized, open-label, phase 3 study of gedatolisib (geda) + fulvestrant (fulv) ± palbociclib (palbo) vs standard of care in patients with HR+/HER2- advanced breast cancer (ABC) (Study 2)

Gedatolisib plus fulvestrant with palbociclib (“gedatolisib triplet”) or without palbociclib (“gedatolisib doublet”) significantly improved median progression-free survival (“PFS”) compared with alpelisib plus fulvestrant in HR+/HER2-, PIK3CA mutant ABC patients with and without liver metastases and those with or without visceral metastases:

Subgroup	Gedatolisib Triplet	Gedatolisib Doublet	Alpelisib + Fulvestrant
No Liver metastases, n	77	28	76
mPFS, mos. (95% CI)	21.5 (11.4-NR)	11.5 (9.2-NR)	9.1 (5.6-16.9)
HR (90% CI) vs. control	0.46 (0.30-0.72)	0.71 (0.41-1.25)
p-value	0.0016	0.1627
Liver Metastases, n	78	24	79
mPFS, mos. (95% CI)	9.1 (5.7-11.1)	11.1 (3.7-NR)	4.6 (3.7-5.6)
HR (90% CI) vs. control	0.47 (0.34-0.65)	0.38 (0.23-0.62)
p-value	<0.0001	0.0006
Subgroup	Gedatolisib Triplet	Gedatolisib Doublet	Alpelisib + Fulvestrant
No Visceral Metastases, n	38	13	37
mPFS, mos. (95% CI)	21.5 (9.6 – NR)	NR (1.6-NR)	9.2 (3.9-16.9)
HR (90% CI) vs. control	0.38 (0.21-0.73)	0.40 (0.15-1.1)
p-value	0.0059	0.0703
Visceral Metastases, n	117	39	118
mPFS, mos (95% CI)	9.8 (7.5-12.9)	11.3 (7.4-22.1)	5.6 (4.6-7.2)
HR (90% CI) vs. control	0.52 (0.39-0.70)	0.53 (0.35-0.79)
p-value	<0.0001	0.0042

* NR, not reached

In patients with evaluable disease, the gedatolisib-based regimens induced higher objective response rates (“ORR”) (confirmed and unconfirmed) and longer median durations of response in both the PIK3CA mutant and wild-type cohorts compared to the control:

Study 2 (PIK3CA Mutant Cohort)
Endpoint	Gedatolisib Triplet (n=133)	Gedatolisib Doublet (n=42)	Alpelisib + Fulvestrant (n=127)
Objective Response Rate, n (%)	78 (59%)	18 (43%)	42 (33%)
Median Duration of Response, mos. (95% CI)	19.4 (11.1-25.1)	27.8 (9.2-NR)	7.5 (5.6 – 16.6)
Study 1 (PIK3CA Wild-type Cohort)
	Gedatolisib Triplet (n=124)	Gedatolisib Doublet (n=113)	Fulvestrant (n=105)
Objective Response Rate, n (%)	48 (39%)	38 (34%)	1 (1%)
Median Duration of Response, mos. (95% CI)	19.2 (10.7-NR)	13.8 (9.4-NR)	Not evaluable

In the PIK3CA mutant cohort, the discontinuation rate of gedatolisib due to treatment-emergent adverse events (“TEAEs”) was 5% and 4% for the gedatolisib triplet and doublet, respectively, compared to a 19% discontinuation rate due to TEAEs for alpelisib. Grade 3 stomatitis with gedatolisib was transient. By the second cycle of treatment, less than 3% of patients had Grade 3 stomatitis, and all grade 3 events improved within 1-2 weeks. Discontinuations due to stomatitis for the gedatolisib triplet and gedatolisib doublet were minimal, 1% and 0%, respectively.

“The additional data from Study 2 of VIKTORIA-1 show consistent and significant clinical benefit for important sub-groups of breast cancer patients treated with gedatolisib regimens,” said Igor Gorbachevsky, Chief Medical Officer of Celcuity. “For patients who do not have liver metastases and received the gedatolisib triplet, the median progression-free survival was approximately 21 months, versus approximately 9 months for the alpelisib regimen. This is a particularly important result since patients with no liver metastases represent approximately 60%-70% of all patients treated in this setting.”

“Additionally, the median duration of response was over 19 months for the gedatolisib triplet in both the PIK3CA wild-type cohort, or Study 1, and the PIK3CA mutant cohort, or Study 2, compared to not evaluable for fulvestrant in the PIK3CA wild-type cohort and 7.5 months for alpelisib plus fulvestrant in the PIK3CA mutant cohort. To our knowledge, the gedatolisib triplet in each study demonstrated the longest median duration of response results ever reported for a therapeutic regimen used in the primary analysis for a Phase 3 trial in the second-line HR+/HER2- advanced breast cancer setting.”

VIKTORIA-1 PIK3CA Wild-Type Cohort Comparative Analysis

Dr. Sara Tolaney, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute, presented a comparative analysis of data for the gedatolisib regimens from the PIK3CA wild-type cohort of VIKTORIA-1 and other regimens evaluated in patients with HR+/HER2- advanced breast cancer.

Poster 1873P: Gedatolisib (Ged) vs Other Regimens Post-CDK4/6i and Endocrine Therapy (ET) in PIK3CA Wild-Type (WT) HR+/ HER2- Advanced Breast Cancer (aBC): A Network Meta-Analysis (NMA)

Eight studies were included in this network meta-analysis comparing progression-free survival outcomes in randomized controlled trials of systemic treatments evaluated among patients with HR+/HER2- advanced breast cancer with CDK4/6 inhibitor experience and PIK3CA wild-type tumors. This analysis found that the gedatolisib triplet and doublet each demonstrated statistically significant or numerically superior improvement in PFS and in progression-free survival rate at 6 months relative to the non-gedatolisib regimens evaluated. Of note, the analysis found that patients treated with the gedatolisib triplet and doublet were a statistically significant 2x and 1.5x more likely to survive without disease progression or death compared to imlunestrant plus abemaciclib, respectively.

About HR+/HER2- Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.¹ More than two million breast cancer cases were diagnosed globally in 2022.¹ While survival rates are high for those diagnosed with early breast cancer, only approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.² HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.²

About Celcuity

Celcuity is a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. The company’s first FDA-approved product is REVTORPYK™ (gedatolisib), pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM (PI3K/AKT/mTOR) pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- locally advanced or metastatic breast cancer, supported FDA approval of REVTORPYK for use in patients without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Results for the PIK3CA mutant cohort of VIKTORIA-1 have been released. VIKTORIA-2 is an ongoing Phase 3 clinical trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib plus palbociclib plus fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib plus palbociclib plus letrozole as first-line treatment for patients with endocrine-sensitive HR+/HER2- ABC. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and X.

Forward Looking Statements

This press release contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of the Company’s clinical trials; the Company’s interpretation of clinical trial data; and the Company’s strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “confidence,” “encouraged,” “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management’s current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that the Company’s topline clinical results are based on an ongoing analysis of efficacy and safety data and such data may change following a more comprehensive review of the data related to the clinical trial; and the development of therapies and tools competitive with gedatolisib. In addition, all forward-looking statements are subject to other risks detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as such risks may be updated in its subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

References

1. Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;10.3322/caac.21660.
2. National Cancer Institute. Surveillance, Epidemiology and End Results Program (accessed July 2025). https://seer.cancer.gov/statfacts/html/breast-subtypes.html

Contacts

For Investors: 
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com   
(763) 392-0123
Jodi Sievers, jsievers@celcuity.com
(415) 494-9924

For Media:
Sam Brown LLC
Laura Morgan, lauramorgan@sambrown.com
(951) 333-9110

ORION CORPORATION
PRESS RELEASE
24 OCTOBER 2026 at 9.35 EEST
        

Darolutamide plus ADT and radiation therapy reduces risk of metastasis or death by 58% in prostate cancer patients at high risk of recurrence

• Interim analysis results from the Phase 3 trial DASL-HiCaP show a 58% reduction in the risk of metastasis or death in the combined primary endpoint of metastasis-free survival (MFS-CI) with darolutamide versus placebo, in addition to androgen deprivation therapy (ADT) and radiation therapy
• Four-year metastasis-free survival rate in trial reached 95% with darolutamide compared to 88% with placebo, alongside secondary endpoint improvements and a safety profile consistent with previous studies
• Results will be presented as a late-breaking abstract in a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2026

ESPOO, Finland, October 24, 2026 – New late-breaking data to be presented today at the European Society for Medical Oncology (ESMO) Congress 2026 will show that adding darolutamide, an androgen receptor inhibitor (ARi) initially discovered by Orion Pharma, to standard-of-care androgen deprivation therapy (ADT) and locoregional radiation therapy (RT), significantly improves metastasis-free survival based on conventional imaging (MFS-CI) in prostate cancer patients with high risk of recurrence compared to placebo. Darolutamide is currently not approved for this treatment setting. These data will be presented at Presidential Symposium I at the ESMO Congress 2026 (LBA4, Saturday 24 October, 16:30 CET).

At a median follow-up of 3.8 years, the interim analysis demonstrated a 58% reduction in the risk of metastasis or death with darolutamide plus ADT and RT compared with placebo plus ADT and RT (hazard ratio [HR] 0.42; 95% CI: 0.27–0.66; p=0.0001). The 4-year metastasis-free survival rate was 95% for patients receiving darolutamide compared with 88% for those receiving placebo.

Secondary endpoints also showed consistent positive trends with darolutamide, with a 53% reduction in the risk of prostate-specific antigen progression free survival (PSA-PFS; HR 0.47; 95% CI: 0.33–0.67), and a 4-year PSA-PFS rate of 91% versus 83% with placebo. Prostate cancer-specific survival (PCSS) and overall survival (OS) hazard ratios were 0.58 (95% CI: 0.17–1.97; 99% vs 99% at 4 years) and 0.88 (95% CI: 0.49–1.59; 97% vs 95% at 4 years), respectively, with follow-up ongoing.

The safety profile of darolutamide was consistent with its known tolerability, with adverse events being similar to the placebo group. Proportions of patients experiencing Grade ≥2 adverse events of special interest for darolutamide versus placebo were: fatigue/asthenia (14% vs 10%), hypertension (7% vs 9%), fractures (2% vs 3%), and cardiac events (3% vs 3%). Any Grade ≥3 adverse event occurred in 43% of patients in the darolutamide group versus 36% in the placebo group.

Follow-up of participants is continuing to provide further information on longer-term outcomes, including overall survival.

About the DASL-HiCaP trial (ANZUP1801)
The DASL-HiCaP trial is an investigator-initiated, randomized, placebo-controlled, Phase III trial (NCT04136353) evaluating darolutamide added to standard-of-care ADT and locoregional radiation therapy in prostate cancer patients at high risk of recurrence. DASL-HiCaP is conducted by the University of Sydney and ANZUP Clinical Trials Group and is the fourth Phase III trial for darolutamide. Following ARAMIS, ARASENS, and ARANOTE, which demonstrated darolutamide’s efficacy and safety in advanced prostate cancer, DASL-HiCaP represents the first Phase III study of darolutamide in early prostate cancer. A total of 1,106 participants across Australia, New Zealand, Canada, the United States, Ireland and the United Kingdom were randomized 1:1 to receive darolutamide (600 mg twice daily) or matching placebo for 96 weeks, combined with an LHRH analog for 96 weeks and RT to the prostate/prostate bed and pelvic lymph nodes. The primary endpoint was metastasis-free survival based on conventional imaging (MFS CI). Secondary endpoints included prostate-specific antigen progression free survival (PSA-PFS), prostate cancer-specific survival (PCSS), and overall survival (OS). The protocol specified an interim analysis after 87 MFS-CI events; follow-up is ongoing to evaluate long-term overall survival.

About Prostate Cancer
Prostate cancer is the second most common cancer and the fourth most common cause of cancer death in men worldwide. Over 1.5 million men are diagnosed with prostate cancer each year and almost 420,000 die from the disease worldwide. By 2040, prostate cancer diagnoses are projected to increase to 2.9 million.

Standard therapy for prostate cancer patients at high risk of recurrence combines radiation therapy with androgen deprivation therapy (ADT). However, despite this approach, a significant proportion of patients experience treatment failure, local recurrence, or distant metastases. Intensifying therapy early with an advanced androgen receptor inhibitor aims to improve long-term disease control and delay metastatic progression.

About darolutamide (Nubeqa™)
Darolutamide is an oral ARi with a unique chemical structure that binds with high affinity to the androgen receptor and exhibits a strong antagonistic effect against the androgen receptor inhibiting the receptor function and growth of prostate cancer cells. Additionally, preclinical models and neuroimaging data in healthy humans, support darolutamide’s low potential for blood-brain barrier penetration and low potential for clinically relevant drug drug interactions.

Darolutamide, under the brand name Nubeqa™ plus androgen deprivation therapy (ADT), is already approved in more than 85 markets around the world, including the US, EU and China. It is approved for the treatment of adult patients with mHSPC without docetaxel in 75 markets and with docetaxel in more than 85 countries, and for adult patients with nmCRPC at high risk of developing metastatic disease in more than 85 countries.

Darolutamide is developed jointly by Orion Pharma and Bayer.

A robust clinical development program is underway investigating darolutamide across various stages of prostate cancer. Current ongoing trials include the Phase III ARASTEP trial evaluating the efficacy of darolutamide plus ADT compared to ADT alone in hormone sensitive prostate cancer (HSPC), in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline.

Media contact:
Maddie Davidshofer, Lead, Scientific & Pipeline Communications
tel. +1 857 529 0169

Investor contact:
Tuukka Hirvonen, Head of Investor Relations
tel. +358 10 426 2721                                                 

Publisher:
Orion Corporation
Communications
Orionintie 1A, FI-02200 Espoo, Finland
http://www.orionpharma.com

Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals as well as active pharmaceutical ingredients, combining our trusted expertise with continuous innovation. We have an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by us are used to treat cancer, respiratory diseases and neurological diseases, among others. In 2025 our net sales amounted to EUR 1,890 million, and we employ about 4,000 professionals worldwide, dedicated to building well-being.

• IMA402 PRAME bispecific continues to demonstrate encouraging anti-tumor activity in multiple indications, alongside a favorable safety profile
• IMA402 achieved a cORR of 32%, 12.5 months median DOR and a 1-year OS rate of 91% in advanced melanoma patients with high PRAME expression
• Clinical profile of IMA402 reinforces development path across multiple solid tumor indications, including melanoma, gynecologic cancers and lung cancer, in earlier and later treatment lines, supported by Immatics’ innovative, rapid liquid biopsy-based PRAME testing
• IMA203CD8 PRAME cell therapy demonstrated deep and durable anti-tumor activity across multiple tumor types with a manageable safety profile, supporting its tumor-agnostic potential. At clinically relevant dose levels in patients with advanced, heavily pretreated gynecologic cancers, cORR was 55% with a median DOR of 8.4 months

Houston, Texas and Tuebingen, Germany, October 24, 2026 – Immatics N.V. (NASDAQ: IMTX, “Immatics” or the “Company”), the global leader in precision targeting of PRAME with multiple clinical-stage programs spanning cell therapies and bispecifics, today announced updated clinical trial data from its ongoing Phase 1b study with IMA402 PRAME bispecific and its Phase 1 study with IMA203CD8 PRAME cell therapy.

The IMA402 data will be presented in a rapid oral presentation (1955RO) by Dirk Schadendorf, M.D., and the IMA203CD8 data were presented in an oral presentation (1946O) by Antonia Busse, M.D., at the 2026 Annual Meeting of the European Society for Medical Oncology (ESMO) in Madrid, Spain. In addition, exploratory analyses of the anzu-cel Phase 1b melanoma cohort will be presented in a poster (2128P) by Sapna Patel, M.D. The slides are available in the ‘Events & Presentations’ section of the Investor & Media page on the Company’s website.

“The data presented at ESMO further underscore the potential of IMA402 as an off-the-shelf treatment option for patients with solid cancers. This promising clinical profile reinforces our strategy as we continue to advance IMA402 across multiple cancer types and treatment lines, with combination approaches further expanding its reach,” said Cedrik Britten, M.D., Ph.D., Chief Medical Officer at Immatics. “In addition, as the IMA203CD8 PRAME cell therapy data continue to mature, we are increasingly encouraged by its broad potential for patients with advanced PRAME-positive cancers. Together with anzu-cel, IMA402 and IMA203CD8 give us three distinct and complementary approaches to target PRAME, with the potential to reach more patients across a broad range of cancers.”

Rapid Oral Presentation Summary – IMA402 PRAME TCR Bispecific Phase 1b Trial

Patient Population: Heavily pretreated patient population with a median of 3 prior lines of therapy
As of the data cutoff on June 1, 2026, 126 heavily pretreated patients across multiple tumor types, primarily melanoma and ovarian cancer, received at least one infusion of IMA402 during the dose escalation or dose expansion part of the ongoing trial (NCT05958121). Patients had received a median of 3 prior lines of systemic treatment, had a median target lesion sum of diameter of 7.4 cm and had a median of 4 tumor lesions. The efficacy population included 40 patients treated within the recommended Phase 2 dose (RP2D) range of 10 to 45 mg across varying levels of PRAME expression. Within this population, 31 patients exhibited high PRAME expression levels (PRAME-high)¹ in their tumors. Of these, all patients with PRAME-high melanoma had received prior systemic treatment with immune checkpoint inhibitors (ICI), with a median of 2 prior ICI regimens and all patients with PRAME-high ovarian cancer were previously treated with platinum-based chemotherapy.

Safety: Favorable tolerability profile as monotherapy and as combination therapy
IMA402 showed favorable tolerability across all doses. The most frequent treatment-related adverse events (TRAEs) were expected, transient lymphopenia and low-grade cytokine release syndrome (CRS), consistent with the mechanism of action. No cases of ICANS were reported. No IMA402-related Grade 5 events were reported. Tolerability was consistent across all evaluated doses, including the RP2D range, with no additive toxicity observed when combined with an ICI.

Anti-tumor Activity and Durability: 32% cORR in PRAME-high melanoma with promising durability and survival
IMA402 showed promising anti-tumor activity as monotherapy (n=36) or in combination with an immune checkpoint inhibitor (n=4) in the efficacy population at RP2D range. Treatment with IMA402 demonstrated 10 confirmed responses resulting in an overall confirmed objective response rate (cORR) of 25% (10/40) and a disease control rate (DCR) of 63% (25/40). This includes one confirmed complete response in melanoma. The longest ongoing response exceeded 2 years. In the PRAME-high population, cORR was 32% (10/31) across all indications and 32% (7/22) in patients with melanoma. The PRAME-high melanoma population further showed a median duration of response (mDOR) of 12.5 months (median follow-up, mFU, 16.8 months). Median overall survival (mOS) was not reached (mFU 8.8 months), with 91% of patients alive at 1 year (versus 60% of patients treated below RP2D range), indicating promising overall survival data irrespective of best response. Among 6 patients with PRAME-high ovarian cancer, 3 confirmed responses were reported.

^a Includes cutaneous melanoma and one patient with uveal melanoma. ^b Includes endometrial cancer (n=2), sqNSCLC (n=2), and synovial sarcoma (n=1); BOR, best overall response; BL, baseline; cCR, confirmed complete response; cORR, confirmed objective response rate; DCR, disease control rate; PD, progressive disease; (c)PR, (confirmed) partial response; SD, stable disease.

BOR, best overall response; BL, baseline; cCR, confirmed complete response; cORR, confirmed objective response rate; PD, progressive disease; (c)PR, (confirmed) partial response; SD, stable disease.

Next Development Steps for IMA402:
The promising clinical profile of IMA402 supports a development path across various solid tumors in earlier and later treatment lines. These include combination approaches with ICIs in melanoma and in gynecologic cancers as well as IMA402 in combination with the Company’s MAGEA4/8-directed bispecific, IMA401, in lung cancer with first data expected in 2027. Furthermore, the use of Immatics’ proprietary rapid, sensitive and reliable liquid biopsy-based PRAME testing enables precise patient selection and could support potential fast-to-market strategies, subject to regulatory approval, in PRAME-high melanoma and beyond.

Oral Presentation Summary – IMA203CD8 PRAME Cell Therapy Phase 1 Trial

Patient population: Heavily pretreated patient population with limited treatment options
As of the data cutoff on August 7, 2026, 98 heavily pretreated patients across multiple advanced solid tumor types expressing PRAME that had undergone a median of 3 prior systemic treatments were enrolled in the ongoing Phase 1 dose escalation/dose expansion trial (NCT03686124). Of these, 90 patients were evaluable for efficacy, including 27 with gynecologic cancers (ovarian and uterine cancer), 44 with melanoma, 12 with synovial sarcoma and 7 with other solid tumor types. All patients with ovarian cancer had received prior platinum-based therapy.

Safety: Treatment with IMA203CD8 was manageable
IMA203CD8 demonstrated a consistent and manageable safety profile across different solid tumor types and a wide dose range (median dose 1.81×10⁹ TCR T cells, range 0.44-12.50×10⁹). The most frequent treatment-emergent adverse events (TEAEs) were expected and included transient cytopenias associated with the lymphodepletion regimen and low-grade cytokine release syndrome (CRS), consistent with the mechanism of action. ICANS was infrequently observed, and no IMA203CD8-related Grade 5 events occurred. Maximum tolerated dose (MTD) was not reached with doses up to 12.5 billion IMA203CD8 cells.

Anti-tumor Activity and Durability: One-time infusion of IMA203CD8 PRAME cell therapy showed anti-tumor activity across multiple tumor types
Across all evaluated dose levels and tumor types, including lower dose levels not selected for further clinical development, a one-time infusion of IMA203CD8 demonstrated an ORR of 51% (46/90) and a cORR of 41% (36/87). The DCR was 82% (74/90) and 83% (71/86) of patients with evaluable target lesions experienced tumor reduction. Responses were observed across multiple solid tumors expressing PRAME, including ovarian cancer, uterine cancer, melanoma, synovial sarcoma, and others. Durable long-term responses were observed with ongoing responses for more than 2.5 years.

3 patients without any post-baseline scan not evaluable for assessment of tumor reduction, not depicted in the plot, but included in efficacy calculations. For patients achieving a (c)CR with <100% change from baseline, target lesions were lymph nodes that resolved to <10 mm per RECIST 1.1; BOR, best overall response; (c)CR, (confirmed) complete response; PD, progressive disease; (c)PR, (confirmed) partial response; SD, stable disease.

In 20 patients with gynecologic cancers (ovarian and uterine cancer) treated at clinically relevant dose levels (≥DL4c), IMA203CD8 demonstrated consistent anti-tumor activity with an ORR of 60% (12/20) and a cORR of 55% (11/20), a DCR of 70% (14/20) and tumor reduction in 68% (13/19) of patients. Early durability data showed a mDOR of 8.4 months (mFU 6.0 months), a mPFS of 5.8 months (mFU 8.1 months) and mOS not reached at 7.8 months mFU.

1 patient without any post-baseline scan not evaluable for assessment of tumor reduction, not depicted in plot, but included in efficacy calculations; those patients achieving a (c)CR with <100% changes from baseline, target lesions were lymph nodes that resolved to <10 mm per RECIST 1.1; BOR, best overall response; (c)CR, (confirmed) complete response; PD, progressive disease; (c)PR, (confirmed) partial response; SD, stable disease.

Next Development Steps for IMA203CD8:
Phase 1a dose escalation is complete. Immatics is currently enrolling patients with uterine cancer at clinically relevant doses to further expand the clinical dataset in this indication. In addition, a Phase 1/2 investigator-initiated trial (IIT) in patients with PRAME-positive pediatric cancers is planned to start in 1H 2027. The clinical activity of IMA203CD8 observed across tumor types with distinct biology and differing levels of PRAME expression, including ovarian cancer, uterine cancer, melanoma and synovial sarcoma, supports the broad applicability of IMA203CD8 across PRAME-positive cancers. The development approach for IMA203CD8 will leverage targeted cohorts of selected tumor types, such as ovarian cancer, uterine cancer, rare cancers and pediatric cancers to build the clinical evidence base for broader, tumor-agnostic application.

Poster Presentation Summary – Anzu-cel Phase 1b Melanoma Cohort
Additional exploratory analyses (data cutoff Sept 24, 2025) of anzu-cel (anzutresgene autoleucel, IMA203), presented in a poster (2128P) by Sapna Patel, M.D., demonstrated durable clinical benefit following a one-time treatment in a heavily pretreated population of patients with advanced melanoma. Durable clinical benefit was observed across patients with varied baseline clinical and treatment characteristics, with no single characteristic identified as a predictor of prolonged PFS. Exploratory analyses suggested that lower tumor burden, lower LDH, and a higher effector-to-target ratio may be associated with longer PFS. These findings further strengthen the clinical profile of anzu-cel, which is currently being evaluated in the Phase 3 SUPRAME trial in advanced melanoma.

About IMA402 PRAME Bispecific
IMA402 is a molecule from Immatics’ TCR bispecifics (TCER®) pipeline directed against an HLA-A*02:01-presented peptide derived from PRAME. IMA402 is currently being evaluated in a Phase 1b clinical trial in patients with solid tumors expressing PRAME. IMA402 is part of Immatics’ strategy to leverage the full clinical potential of targeting PRAME, one of the most promising targets for TCR-based therapies.

About IMA203CD8 PRAME Cell Therapy
IMA203CD8 is Immatics’ PRAME-directed TCR T-cell therapy engineered to recognize an intracellular PRAME-derived peptide presented by HLA-A*02:01 on the cell surface and initiate a potent and specific anti-tumor response. Co-transduction of CD8αβ with the PRAME TCR adds functional CD4+ T cells designed to boost anti-tumor activity. IMA203CD8 is currently being evaluated in a Phase 1b clinical trial in solid tumors expressing PRAME.

About Anzu-cel PRAME Cell Therapy
Anzu-cel (anzutresgene autoleucel; IMA203) is a PRAME-directed TCR T-cell therapy engineered to recognize an intracellular PRAME-derived peptide presented by HLA-A*02:01 on the cell surface and initiate a potent and specific anti-tumor response. Anzu-cel PRAME cell therapy is currently being evaluated in a registration-enabling randomized controlled Phase 3 trial, “SUPRAME,” in patients with unresectable or metastatic melanoma who have disease progression on or after treatment with at least one checkpoint inhibitor. In parallel, the Phase 1/2 clinical trial is ongoing with a focus on uveal melanoma.

About PRAME
PRAME is a tumor-associated target expressed in more than 50 cancers. Immatics’ PRAME franchise includes multiple product candidates, therapeutic modalities, indications and combination approaches: anzu-cel (anzutresgene autoleucel; IMA203) and IMA203CD8, both PRAME-directed cell therapies, and IMA402, a PRAME-directed bispecific. Combination approaches include IMA402 with immune checkpoint inhibitors, IMA402 with the MAGEA4/8-directed bispecific IMA401, and anzu-cel in combination with Moderna’s PRAME mRNA therapy designed to enhance the cell therapy response.

About Immatics
Immatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME, a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCR bispecifics.

Immatics intends to use its website www.immatics.com as a means of disclosing material non-public information. For regular updates, you can also follow us on LinkedIn and Instagram.

Forward-Looking Statements
Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or the Company’s future financial or operating performance. For example, statements concerning timing of data read-outs, the timing, outcome and design of clinical trials, the nature of clinical trials (including whether such clinical trials will be registration-enabling), the timing and outcomes of IND, CTA, BLA and other regulatory filings, the timing of commercial launches, estimated market opportunities, manufacturing timetables, capacity and success rates, the potential benefits of product candidates, the Company’s intended strategy, and other metrics are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “plan”, “target”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management’s control including general economic conditions and other risks, uncertainties and factors set forth in the Company’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission (SEC). Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. The Company undertakes no duty to update these forward-looking statements. All the scientific and clinical data presented within this press release are – by definition prior to completion of the clinical trial and a clinical study report – preliminary in nature and subject to further quality checks including customary source data verification.

For more information, please contact:

Media
Trophic Communications
Phone: +49 151 74416179
immatics@trophic.eu

Immatics N.V.
Jordan Silverstein
Head of Strategy
Phone: +1 346 319-3325
InvestorRelations@immatics.com

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¹ Patients showed PRAME expression 3-fold higher than the PRAME qPCR threshold, based on an exploratory analysis in the efficacy population. More than 80% of patients with cut. melanoma are estimated to have PRAME-high expression based on Immatics and TCGA RNA seq data.

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