Author: Ravi Shankar

Media Release

COPENHAGEN, Denmark; October 25, 2026

• Petosemtamab demonstrates encouraging objective response rates (ORRs), with promising depth and durability of response, in first- and second-line metastatic colorectal cancer (mCRC)
• Data reinforces the ongoing global Phase 3 trials of petosemtamab in mCRC, which are actively enrolling patients

Genmab A/S (Nasdaq: GMAB) today announced updated follow-up analyses from a Phase 2 trial evaluating petosemtamab, an 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 FOLFOX or FOLFIRI in patients with metastatic colorectal cancer (mCRC). At a median follow-up of 5.9 months in the first-line (1L) setting and 7.1 months in the second-line (2L) setting, confirmed and unconfirmed objective response rates (ORRs) were 75% and 67%, respectively, with an ORR of 81% observed among 1L patients with left-sided tumors. With longer follow-up, most of the previously unconfirmed objective responses were subsequently confirmed, reinforcing the consistency of the clinical activity observed across treatment settings. The updated analyses reinforce the depth and durability of responses observed in both 1L and 2L treatment settings and support the ongoing global Phase 3 development program. The findings were presented at the European Society for Medical Oncology (ESMO) Congress 2026, held in Madrid, Spain.

“Despite advances in the treatment of metastatic colorectal cancer, outcomes remain poor for many patients once disease has spread, including those with RAS/BRAF wild-type disease who may face limited options after standard chemotherapy and targeted therapy,” said Ruth Vera, M.D., Medical Oncology Department, Hospital Universitario de Navarra, and study investigator. “The encouraging response rates observed in both the first- and second-line settings, along with the maturation of the dataset over time, suggest that treatment with petosemtamab plus chemotherapy may offer a potential new approach for these patients.”

As of May 15, 2026, 79 patients were treated with the petosemtamab combination, including 45 patients in the 1L setting and 34 patients in the 2L setting. Among efficacy-evaluable patients, confirmed and unconfirmed ORR was 75% in 1L patients and 67% in 2L patients. In 1L patients with left-sided tumors, ORR was 81%. Responses were observed across key patient subgroups, including patients with liver metastases, which is a poor prognostic factor in mCRC, with ORRs of 76% and 67% in the 1L and 2L settings, respectively. Median follow-up was 5.9 months in the 1L setting and 7.1 months in the 2L setting, with 76% and 74% of patients, respectively, remaining on treatment at the data cutoff. Disease control rate was 95% in 1L patients and 93% in 2L patients.

Petosemtamab-related treatment-emergent adverse events (TEAEs) led to petosemtamab discontinuation in 2 of 42 patients (5%) treated with petosemtamab + mFOLFOX6 and in 1 of 37 patients (3%) treated with petosemtamab + FOLFIRI. No TEAEs leading to death were reported. Infusion-related reactions (IRRs) occurred in 48% of patients receiving petosemtamab plus FOLFOX and 43% of patients receiving petosemtamab plus FOLFIRI; grade 3 IRRs occurred in 3 of 42 (7%) and 1 of 37 (3%) patients, respectively.

“These updated Phase 2 results presented at ESMO continue to build on the encouraging clinical efficacy of petosemtamab,” said Tahamtan Ahmadi, M.D., Ph.D., Executive Vice President and Chief Medical Officer, Head of Experimental Medicines, Genmab. “The confirmation of previously unconfirmed responses with longer follow-up further reinforces the durability of responses observed across treatment lines and strengthens our confidence in petosemtamab. The data provide a compelling rationale for our ongoing global Phase 3 trials, where we aim to establish the potential benefit for patients in 1L and 2L settings.”

Petosemtamab has the only triple mechanism of action that uniquely targets the LGR5+ stem-like cancer cells that drive tumor recurrence and metastases in epithelial cancers. In addition to this ongoing Phase 1/2 trial (NCT03526835), the petosemtamab clinical program includes four Phase 3 LiGeR trials: in 1L PD-L1+ recurrent or metastatic head and neck squamous cell carcinoma (r/m HNSCC) (LiGeR-HN1; NCT06525220); in 2L/3L r/m HNSCC (LiGeR-HN2; NCT06496178), in 1L RAS/BRAF wild-type, left-sided unresectable or metastatic CRC (LiGeR-CRC1; NCT07702032); and in 2L RAS/BRAF wild-type recurrent, unresectable, or metastatic CRC (LiGeR-CRC2; NCT07775287).

On Wednesday, October 28 at 5:00 p.m. CET/12:00 p.m. EDT, Genmab will host an investor update. To register, visit genmab.com/events-presentations.

About the Phase 2 Petosemtamab Trial (NCT03526835)
The Phase 2 trial (NCT03526835) is an ongoing, single-arm, open-label, multicenter study evaluating petosemtamab as monotherapy and in combination with standard-of-care therapies across multiple solid tumors, including metastatic colorectal cancer. Patients with left- and/or right-sided, RAS/BRAF wildtype, anti-EGFR naïve mCRC received 1500 mg of petosemtamab every two weeks plus FOLFOX or FOLFIRI until disease progression or unacceptable toxicity. Patients were treated either in 1L or 2L setting after one prior chemotherapy regimen. The primary endpoints include investigator-assessed objective response rate (ORR) and safety.

About Colorectal Cancer (CRC)
Colorectal cancer (CRC) is a malignant disease of the colon or rectum and is the third most commonly diagnosed cancer globally, with an estimated 1.9 million new cases annually.ⁱ While CRC is typically diagnosed in older adults, incidence is increasing among younger individuals in many countries.ⁱⁱ In metastatic CRC, treatment selection is increasingly informed by molecular characteristics, including RAS and BRAF mutation status, primary tumor sidedness, and prior therapy.ⁱⁱⁱ Patients with RAS/BRAF wild-type metastatic CRC may be eligible for EGFR-targeted treatment approaches in 1L settings for left-sided tumors and in 2L settings for both left- and right-sided tumors.ⁱⁱⁱ Survival outcomes vary widely by stage and geographic region, with an estimated five-year survival rate of 15% in late-stage metastatic CRC.^iv

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). Please visit https://clinicaltrials.gov/ for more information.

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.

Contact:
David Freundel, Senior Director, Global Communications & Corporate Affairs
T: +1 609 613 0504; E: dafr@genmab.com

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

This Media Release contains forward-looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward-looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab^®; the Y-shaped Genmab logo^®; Genmab in combination with the Y-shaped Genmab logo^®; HuMax^®; DuoBody^®; HexaBody^®; DuoHexaBody^®, HexElect^®, and KYSO^®.

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ⁱ World Health Organization. “Colorectal cancer.” World Health Organization, accessed May 14, 2026. https://www.who.int/news-room/fact-sheets/detail/colorectal-cancer.
ⁱⁱ Sung H, Siegel RL, Laversanne M, Jiang C, Morgan E, Zahwe M, Cao Y, Bray F, Jemal A. “Colorectal cancer incidence trends in younger versus older adults: an analysis of population-based cancer registry data.” Lancet Oncol, 2025 Jan;26(1):51-63. doi: 10.1016/S1470-2045(24)00600-4. Epub 2024 Dec 12. PMID: 39674189; PMCID: PMC11695264.
ⁱⁱⁱ Cremolini C, Chalabi M, Elez E, et al. Metastatic colorectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Annals of Oncology. 2026.
^iv National Cancer Institute. “Colorectal cancer—cancer stat facts.” Surveillance, Epidemiology, and End Results Program (SEER)”, accessed May 14, 2026. Cancer of the Colon and Rectum – Cancer Stat Facts

Media Release no. 14
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Carl Jacobsens Vej 30
2500 Valby
Denmark

Attachment

• 251026_MR14_Peto_mCRC_ESMO2026

Longer-term data reflecting nearly 4 years of follow-up show a further reduction in the risk of death from 14% to 37% for those initially treated with Libtayo, despite an 88% crossover from the placebo arm upon recurrence 

New prospective analyses confirm sustained disease-free survival (DFS) benefit with adjuvant Libtayo, including in patients who are minimal residual disease (MRD) negative at baseline

The late-breaking data were presented during a rapid oral session at the European Society for Medical Oncology (ESMO) 2026 Meeting

TARRYTOWN, N.Y., Oct. 25, 2026 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced longer-term data reflecting nearly four years of follow-up from the Phase 3 C-POST trial evaluating PD-1 inhibitor Libtayo^® (cemiplimab) as adjuvant treatment for patients with cutaneous squamous cell carcinoma (CSCC) at a high risk of recurrence after surgery and radiation. The late-breaking results were presented in a rapid oral session at the European Society for Medical Oncology (ESMO) Congress 2026.

“As the Phase 3 C-POST trial data continue to mature, we are seeing an evolving and clinically meaningful overall survival benefit with adjuvant Libtayo in high-risk cutaneous squamous cell carcinoma, as well as sustained disease-free survival benefit regardless of whether minimal residual disease is detectable at baseline,” said Danny Rischin, M.D., M.B.B.S., F.R.A.C.P., Research Lead, Head and Neck Cancer and Cutaneous SCC, Department of Medical Oncology at the Peter MacCallum Cancer Centre in Melbourne, Australia, and lead investigator of the trial. “These data provide compelling evidence of the long-term, durable benefit of adjuvant treatment with Libtayo in high-risk CSCC after surgery and radiation, further supporting Libtayo as a transformative standard of care for these patients.”

With a median follow-up of 44 months, efficacy results for Libtayo compared to placebo showed sustained benefits for the primary endpoint of disease-free survival (DFS), and notably, an increasing overall survival (OS) benefit, a secondary endpoint. Specifically, there was a 37% reduction in the risk of death (hazard ratio [HR]: 0.63; 95% confidence interval [CI]: 0.36-1.11) at a median follow up of 44 months, up from 22% at a median follow up of 30 months (HR: 0.78; 95% CI: 0.39-1.56) and 14% at a median follow up of 24 months (HR: 0.86; 95% CI: 0.39-1.90). Notably, patients randomized to placebo were able to cross over to Libtayo after recurrence, and 61 of 69 placebo patients (88%) with recurrence received subsequent Libtayo. The emerging OS benefit, despite the high crossover rate, therefore supports treating high-risk patients with Libtayo after surgery and radiation, rather than waiting for their disease to recur.

Additionally, an exploratory analysis of patients with baseline circulating tumor DNA (ctDNA) data (Libtayo n=93; placebo n=98) was conducted. Compared to placebo, treatment with adjuvant Libtayo improved DFS regardless of baseline minimal residual disease (MRD) status, supporting the broad clinical utility of adjuvant Libtayo in high-risk CSCC. In particular, patients who were MRD negative at baseline – and thus had lower risk of recurrence – still had improved DFS with Libtayo (HR: 0.45; 95% CI: 0.22-0.95); patients who were MRD positive at baseline also had improved DFS with Libtayo (HR: 0.24; 95% CI: 0.07-0.86).

Safety results remained consistent with previously reported data. Treatment emergent adverse events (TEAEs) of any grade occurred in 94% of patients in the Libtayo arm and 91% of patients in the placebo arm. Grade ≥3 TEAEs occurred in 26% of patients (Libtayo) and 17% of patients (placebo). Treatment discontinuations due to TEAEs occurred in 10% of patients (Libtayo) and 3% of patients (placebo). TEAEs leading to death occurred in 2% of patients in each arm.

The longer-term C-POST data at ESMO expand on results shared at the 2025 ASCO Annual Meeting and simultaneously published in the New England Journal of Medicine. Libtayo has since been approved by the U.S. Food and Drug Administration (October 2025) and the European Commission (November 2025) as the first and only immunotherapy for this indication.

About the Phase 3 Trial
C-POST was a randomized, placebo-controlled, double-blind, multicenter, global Phase 3 trial investigating Libtayo versus placebo as adjuvant treatment for patients with features associated with a high-risk of CSCC recurrence and who had completed surgery and post-operative radiation therapy. Trial participants were at high risk of recurrence due to nodal features (extracapsular extension or ≥3 involved lymph nodes) and/or non-nodal features (in-transit metastases, T4 lesion, perineural invasion, or locally recurrent tumor with ≥1 additional poor prognostic features).

The trial enrolled 415 patients who were randomized to receive either Libtayo (n=209) or placebo (n=206) for up to 48 weeks. For the first 12 weeks, Libtayo 350 mg or placebo was administered intravenously every three weeks, followed by Libtayo 700 mg or placebo administered intravenously every six weeks for 36 weeks. After disease recurrence, patients randomized to placebo could cross over to receive Libtayo, and patients randomized to Libtayo could receive Libtayo again, if recurrence was ≥3 months since the last dose of adjuvant Libtayo.

About Regeneron in Cancer
We aspire to turn revolutionary discoveries into medicines that can transform the lives of those impacted by cancer. Our team around the world is driven to solve the needs and challenges of those affected by one of the most serious diseases of our time.

Backed by our legacy of scientific innovation and a deep understanding of biology, genetics and the immune system, we’re pursuing potential therapies across more than 30 types of solid tumors and blood cancers. Our cancer strategy is powered by cutting-edge technologies and therapies that can be flexibly combined to investigate potentially transformative treatments for patients. Oncology assets in clinical development comprise nearly half of Regeneron’s pipeline, and include checkpoint inhibitors, bispecific antibodies and costimulatory bispecific antibodies. Our approved PD-1 inhibitor Libtayo serves as the backbone of many of our investigational combinations.

To complement our extensive in-house capabilities, we collaborate with patients, healthcare providers, governments, biopharma companies and each other to further our shared goals. Together, we are united in the mission to serve as a beacon of transformation in cancer care.

About Libtayo
Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron’s proprietary VelocImmune^® technology. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. Libtayo has been approved by regulatory authorities in more than 30 countries in one or more indications, including for certain adult patients with advanced basal cell carcinoma (BCC), CSCC that is advanced or at high risk of recurrence, advanced non-small cell lung cancer (NSCLC) and advanced cervical cancer.

In the U.S., the generic name for Libtayo in its approved indications is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. FDA. Outside of the U.S., the generic name of Libtayo in its approved indications is cemiplimab.   

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

U.S. FDA-approved Indications
Libtayo is a prescription medicine used to treat:

• Adults with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC):
  • that has spread or cannot be cured by surgery or radiation, or
  • to help prevent CSCC from coming back if your CSCC is at high risk of coming back after it has been removed by surgery and radiation.
• Adults with a type of skin cancer called basal cell carcinoma (BCC) when your BCC cannot be removed by surgery (locally advanced BCC) or when it has spread (metastatic BCC) and have received treatment with a hedgehog pathway inhibitor (HHI), or cannot receive treatment with a HHI.
• Adults with a type of lung cancer called non-small cell lung cancer (NSCLC).
  • LIBTAYO may be used in combination with chemotherapy that contains a platinum medicine as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene.
  • LIBTAYO may be used alone as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high “PD-L1,” and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene.

It is not known if Libtayo is safe and effective in children. 

IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS 

What is the most important information I should know about LIBTAYO?
LIBTAYO is a medicine that may treat certain cancers by working with your immune system. LIBTAYO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

• Lung problems: cough, shortness of breath, or chest pain
• Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual, stools that are black, tarry, sticky or have blood or mucus, or severe stomach-area (abdomen) pain or tenderness
• Liver problems: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach-area (abdomen), dark urine (tea colored), or bleeding or bruising more easily than normal
• Hormone gland problems: headache that will not go away or unusual headaches, eye sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, dizziness or fainting, or changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
• Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, or loss of appetite
• Skin problems: rash, itching, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms, or swollen lymph nodes
• Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with LIBTAYO. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles, confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight, persistent or severe muscle pain or weakness, muscle cramps, low red blood cells, or bruising
• Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: nausea, vomiting, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain, or facial swelling
• Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ or tissue transplant that you have had
• Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with LIBTAYO. Your healthcare provider will monitor you for these complications

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with LIBTAYO. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with LIBTAYO if you have severe side effects.

Before you receive LIBTAYO, tell your healthcare provider about all your medical conditions, including if you:

• have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• have received an organ or tissue transplant, including corneal transplant
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have received radiation treatment to your chest area
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
• are pregnant or plan to become pregnant. LIBTAYO can harm your unborn baby

Females who are able to become pregnant:

• • Your healthcare provider will give you a pregnancy test before you start treatment
  • You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of LIBTAYO. Talk to your healthcare provider about birth control methods that you can use during this time
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LIBTAYO
• are breastfeeding or plan to breastfeed. It is not known if LIBTAYO passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of LIBTAYO

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of LIBTAYO when used alone to treat CSCC that has spread or cannot be cured by surgery or radiation, BCC or NSCLC include tiredness, muscle or bone pain, rash, diarrhea, and low levels of red blood cells (anemia).

The most common side effects of LIBTAYO when used alone to help prevent CSCC from coming back include rash and itching.

The most common side effects of LIBTAYO when used in combination with platinum-containing chemotherapy to treat NSCLC include hair loss, muscle or bone pain, nausea, tiredness, numbness, pain, tingling, or burning in your hands or feet, and decreased appetite.

These are not all the possible side effects of LIBTAYO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals at 1-877-542-8296.

Please see full Prescribing Information, including Medication Guide.  

About Regeneron’s VelocImmune Technology
Regeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron’s Co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite^® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes Dupixent^® (dupilumab), Libtayo, Praluent^® (alirocumab), Kevzara^® (sarilumab), Evkeeza^® (evinacumab-dgnb), Inmazeb^® (atoltivimab, maftivimab and odesivimab-ebgn), Veopoz^® (pozelimab-bbfg) and Pasatru™ (garetosmab-grts). In addition, REGEN-COV^® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024. A total of 11 antibody and bispecific products have been approved or authorized worldwide that were invented or derived using VelocImmune technologies.

About Regeneron 
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite^®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center^® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.

Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation Libtayo^® (cemiplimab) as adjuvant treatment for patients with cutaneous squamous cell carcinoma at a high risk of recurrence after surgery and radiation; uncertainty of the utilization, market acceptance, and/or commercial success of Regeneron’s Products (such as Libtayo) and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron’s Products (such as Libtayo) and Regeneron’s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes to drug pricing regulations and requirements and Regeneron’s pricing strategy, including in connection with Regeneron’s April 2026 agreements with the U.S. government; other changes in laws, regulations, and policies affecting the healthcare industry; competing products and product candidates (including biosimilar products) that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron’s business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney’s Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA^® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2025 and its Form 10-Q for the quarterly period ended June 30, 2026. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron’s media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals).

Contacts: Media Relations Taylor Ramsey Skott Tel: +1 914-409-2381 taylor.ramsey@regeneron.com

Investor Relations Mark Hudson Tel: +1 914-847-3482 mark.hudson@regeneron.com

• Pumitamig plus docetaxel demonstrated encouraging responses in squamous and non-squamous non-small cell lung cancer across PD-L1 expression levels with a confirmed objective response rate of 36.7% following progression on or after immunotherapy plus chemotherapy
• An early median progression-free survival of 6.9 months was observed
• Significant unmet need remains for patients who have progressed on an immunotherapy-containing regimen, with the average progression-free survival below 4 months for standard of care docetaxel
• Data represent the third global Phase 2 dataset for pumitamig in lung cancer and reinforce its potential to improve outcomes over current standards of care 

MAINZ, Germany, and PRINCETON, USA, October 25, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Bristol Myers Squibb Company (NYSE: BMY, “BMS”) today announced first data from the global Phase 2 ROSETTA Lung-107 clinical trial (NCT06841055) evaluating pumitamig, an investigational PD-L1xVEGF-A bispecific immunomodulator (BNT327/BMS986545), in combination with docetaxel in patients with metastatic non-small cell lung cancer (“NSCLC”) whose disease progressed on or after first-line immunotherapy plus chemotherapy.

The data showed encouraging antitumor activity, with responses observed in both squamous and non-squamous NSCLC and across PD-L1 expression levels, together with a manageable safety profile consistent with prior global datasets for pumitamig. The data were presented today in a late-breaking rapid oral presentation (abstract #LBA76) at the European Society for Medical Oncology (“ESMO”) Congress 2026 in Madrid, Spain.

“Despite meaningful advances in first-line treatment, outcomes remain poor for the many patients with non-small cell lung cancer whose disease progresses after immunotherapy plus chemotherapy, a setting where docetaxel has remained the standard of care for years,”¹ said Byoung Chul Cho, M.D., Ph.D., Trial Investigator and Professor of Medical Oncology at Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea. “These first data from ROSETTA Lung-107 show encouraging response rates and progression-free survival across PD-L1 expression levels and histology, suggesting that pumitamig may help re-engage antitumor immunity in patients who have progressed on prior immunotherapy plus chemotherapy. These findings support continued investigation of pumitamig in this population with high unmet need.”

ROSETTA Lung-107 is evaluating pumitamig 1400 mg in combination with docetaxel every three weeks. The July 10, 2026, data cut-off included 50 patients with a median follow-up of 12.2 weeks, and 33 patients remained on treatment. Among 30 efficacy-evaluable patients, pumitamig plus docetaxel showed a confirmed objective response rate (“cORR”) of 36.7% with a disease control rate (“DCR”) of 90.0%. Responses were observed across PD-L1 expression levels (cORR: 42.9% TPS ˂ 1%; 33.3% TPS 1–49%; 40.0% TPS ≥ 50%) and histologies (cORR: 57.1% squamous; 30.4% non-squamous), with DCRs above 80% in all subgroups. Median time to response was 1.4 months. In the overall treated population (n=50), median progression-free survival (“PFS”) was 6.9 months (95% CI: 4.2 – not reached), with a six-month PFS rate of 63.3%. Historically, standard-of-care docetaxel has delivered a median PFS of approximately 3.6 or 3.9 months for non-squamous and squamous metastatic NSCLC patients, respectively, following prior immunotherapy plus chemotherapy.¹

“Our ambition is to improve outcomes for patients across the full spectrum of lung cancer, spanning disease subtypes, stages and lines of therapy,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “These encouraging results for pumitamig plus docetaxel extend the clinical evidence to patients whose disease has progressed after immunotherapy plus chemotherapy, a setting in which treatment options remain limited. Together with our findings in first-line NSCLC and extensive-stage small cell lung cancer, they support our strategy to develop pumitamig across a broad range of lung cancer settings, including those with particularly high unmet medical need.”

“This is the third global Phase 2 dataset to show consistent activity for pumitamig in lung cancer across PD-L1 expression levels, and it extends our evidence into a second-line setting where current options fall short,” said Cristian Massacesi, Executive Vice President, Chief Medical Officer and Head of Development at Bristol Myers Squibb. “Together with BioNTech, we are advancing one of the broadest development programs in the class as we continue to build the growing body of clinical evidence for pumitamig across multiple types and treatment lines of lung cancer, with four ongoing global Phase 3 trials, and we look forward to defining the path forward for pumitamig in second-line NSCLC.”

Across 50 patients in the safety evaluation, pumitamig plus chemotherapy showed a manageable safety profile, with no new safety signals. Pumitamig treatment-related adverse events (“TRAEs”) of any grade were reported in 52.0% of patients and grade ≥ 3 TRAEs in 18.0%, leading to treatment discontinuation in four (8.0%) patients. Immune- related AEs occurred in 11 (22.0%) patients and grade ≥ 3 immune- related AEs in five (10.0%) patients. VEGF-related events were reported in 13 (26.0%) patients; grade 3 events were rare (two patients, 4.0%), with no grade 4 or 5 events. Bleeding events occurred in eight (16.0%) patients and were limited to grade 1 or 2 severity. There were no pumitamig-related deaths or dose-limiting toxicities (“DLTs”).

BioNTech and BMS are advancing a broad development plan for pumitamig in multiple cancer types, including lung cancer across disease stages, subgroups and lines of therapy. ROSETTA Lung-107 extends the program into the second-line NSCLC setting, and these data will inform the further development of pumitamig in this underserved patient population.

About ROSETTA Lung-107
The global, open-label, single-arm Phase 2 ROSETTA Lung-107 trial (NCT06841055) is evaluating pumitamig (BNT327/BMS986545) in combination with docetaxel in patients with stage IV squamous or non-squamous NSCLC whose disease progressed following first-line immunotherapy plus chemotherapy, with any level of PD-L1 expression. Patients with prior exposure to anti-VEGF monoclonal antibodies or PD-(L)1xVEGF bispecific antibodies were excluded. In Part 1 (safety run-in), patients received pumitamig 1400 mg or 2000 mg plus docetaxel 75 mg/m² every three weeks (Q3W). In Part 2 (dose expansion), patients received pumitamig 1400 mg plus docetaxel 75 mg/m² Q3W, the dose recommended by the internal review committee based on the totality of evidence from Part 1 and the broader pumitamig lung cancer program. The primary endpoints are dose-limiting toxicities (Part 1 only), safety, and objective response rate (“ORR”) per investigator’s assessment (RECIST 1.1). Secondary endpoints include disease control rate (“DCR”), duration of response (“DOR”), depth of response, time to response, progression-free survival (“PFS”), overall survival (“OS”), pharmacokinetics, and antidrug antibody prevalence. The trial enrolled 59 patients at sites in Australia, the Republic of Korea, Spain, Türkiye, the United Kingdom, and the United States.

About Pumitamig
Pumitamig is an investigational bispecific immunomodulator, jointly developed by BioNTech and BMS, designed to cooperatively bind to PD-L1 and VEGF-A. It is aimed at restoring the immune system’s ability to recognize and destroy tumor cells while simultaneously cutting off the blood and oxygen supply that feeds tumor cells (anti-angiogenesis effect), preventing them from growing and proliferating. By anchoring to PD-L1 receptors on tumor cells, we believe pumitamig localizes VEGF-A blockade within the tumor microenvironment, potentially enhancing antitumor activity while minimizing systemic exposure.

More than 4,000 patients have been treated with pumitamig in clinical trials to date. Seven global Phase 3 trials with registrational potential are currently ongoing, evaluating pumitamig plus chemotherapy compared to standard of care treatments, in first-line small cell lung cancer (ROSETTA Lung-01, NCT06712355); first-line non-small cell lung cancer (ROSETTA Lung-02, NCT06712316); unresectable stage III non-small cell lung cancer (ROSETTA Lung-201, NCT07361497); first-line advanced PD-L1 ≥ 50% non-small cell lung cancer (ROSETTA Lung-202, NCT07361510); first-line triple-negative breast cancer (ROSETTA Breast-01, NCT07173751); first-line microsatellite stable colorectal cancer (ROSETTA CRC-203, NCT07221357); and first-line gastric cancer (ROSETTA Gastric-204, NCT07221149). Pumitamig is also being explored in 10+ novel-novel combination trials with ADCs and other novel modalities, with the aim of expanding its role across tumor types and identifying additional pivotal opportunities.

About NSCLC
Non-small cell lung cancer (NSCLC) covers all epithelial lung cancers other than small cell lung cancer and includes squamous cell carcinoma, large cell carcinoma, and adenocarcinoma of the lung. It is the most common type of lung cancer, accounting for approximately 85% of cases, and is the leading cause of cancer-related deaths worldwide.² Scientific advances have transformed the treatment of NSCLC, improving outcomes for many patients. However, NSCLC remains an aggressive disease with a poor prognosis and a 5-year survival rate of 18 to 22% in advanced stages.³ Patients with low levels of PD-L1 expression typically do not respond well to checkpoint inhibitor-based regimens creating a significant unmet need for new treatment options that provide durable responses to a broad range of patients.

About BioNTech
BioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody-drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer.

For more information, please visit www.BioNTech.com.

BioNTech Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: BioNTech’s collaboration with Bristol Myers Squibb (BMS); BioNTech and BMS’s ability to successfully co-develop and co-commercialize pumitamig (also known as BNT327 or BMS986545), if approved; the rate and degree of market acceptance of pumitamig, if approved; the initiation, timing, progress, and results of BioNTech’s research and development programs, including BioNTech’s current and future clinical trials, including statements regarding the expected timing of initiation, enrollment, and completion of trials and related preparatory work and the availability of results, and the timing and outcome of applications for regulatory approvals and marketing authorizations, including expectations regarding the potential indications in which pumitamig may be approved, if at all; the targeted timing and number of additional potentially registrational trials, and the registrational potential of any trial BioNTech may initiate; and discussions with regulatory agencies. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.

The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with clinical data, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the impact of tariffs and escalations in trade policy; competition related to BioNTech’s product candidates; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech’s product candidates and investigational medicines; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market its product candidates, if approved; BioNTech’s ability to manage its development and related expenses; regulatory and political developments in the United States and other countries; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; and other factors not known to BioNTech at this time.

You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended June 30, 2026 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at www.sec.gov. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise.

About Bristol Myers Squibb
At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com and follow us on LinkedIn, X, YouTube, Facebook and Instagram.

Bristol Myers Squibb Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about Bristol Myers Squibb’s future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that the expected benefits of, and opportunities related to the collaboration with BioNTech may not be realized by Bristol Myers Squibb or may take longer to realize than anticipated, that future study results may not be consistent with the results to date, that pumitamig (also known as BNT327 or BMS986545) alone or in combination with chemotherapy (such as docetaxel) may not achieve its primary study endpoint or receive regulatory approval for the indications described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether pumitamig alone or in combination with chemotherapy will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2025, as updated by Bristol Myers Squibb’s subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

CONTACTS

BioNTech
Media Relations
Jasmina Alatovic
Media@biontech.de

Investor Relations
Douglas Maffei, PhD
Investors@biontech.de

Bristol Myers Squibb
Media Relations
media@bms.com  

Investor Relations
Investor.relations@bms.com

1. Ahn MJ et al. J Clin Oncol. 2025;43(3):260–272.
2. Lin Z et al. Medicine (Baltimore). 2025 Jul 25;104(30):e43300.
3. Liu SV et al. Immunotherapy. 2025 Oct;17(14):1005-1013.

Low dose (200 mg) budoprutug demonstrated B-cell depletion, PLA2R Ab reduction, and immunologic remission at 12 weeks, consistent with Phase 1b data; additional data from the PrisMN Phase 2 study anticipated in 2027

200 mg and 600 mg doses have been generally well-tolerated

Separate MCD case study described three-year steroid-free remission following budoprutug treatment, supporting further investigation

WELLESLEY HILLS, Mass., Oct. 24, 2026 (GLOBE NEWSWIRE) — Climb Bio, Inc. (Nasdaq: CLYM), a clinical stage biotechnology company developing therapeutics for patients with immune-mediated diseases, today announced new clinical data for budoprutug, its anti-CD19 monoclonal antibody (mAb), in two immune-mediated renal diseases, primary membranous nephropathy (pMN) and minimal change disease (MCD). These data were presented at the American Society of Nephrology (ASN) Kidney Week 2026, which is taking place October 21-25, 2026, in Denver, Colorado.

PrisMN is an ongoing Phase 2 dose-escalation trial evaluating budoprutug at three dose levels (200 mg, 600 mg, and 1000 mg) in patients with moderate to severe pMN. Patients enrolled in the reported cohorts were treatment-experienced, with high proteinuria and elevated PLA2R antibody levels at baseline. At Week 12, the 200 mg cohort demonstrated B-cell depletion, reductions in PLA2R antibody levels, and immunologic remission. Initial data from the ongoing 600 mg cohort suggest greater drug exposure and deeper peripheral B-cell depletion compared with 200 mg. Budoprutug has been generally well tolerated in both cohorts to date, with follow-up through Week 12 for 200 mg and Week 6 for 600 mg. Enrollment is ongoing in the 1000 mg cohort.

In a separate case study presented yesterday, one patient with frequently relapsing MCD received 100 mg of budoprutug. The patient experienced three-year steroid-free remission and remained in remission for one year following B-cell reconstitution. This observation supports further investigation of budoprutug in MCD.

“Current treatment strategies fail to induce complete remission in most patients with pMN, underscoring the need for more effective treatments,” said Dr. Frank Cortazar, Director of the New York Nephrology Vasculitis and Glomerular Center. “While complete remission often takes more than a year to achieve, changes in PLA2R antibody levels can be appreciated much earlier in the treatment course and serve as an early indicator of therapeutic efficacy. Reductions in PLA2R antibody levels have been shown to correlate with downstream improvements in proteinuria, and ultimately complete remission. In the PrisMN study, the low-dose budoprutug cohort demonstrated encouraging PLA2R antibody reductions and immunologic remission rates in patients with moderate to severe pMN. These early results are highly promising, and I look forward to seeing how these data evolve as follow-up continues and higher-dose cohorts read out. These data provide further evidence that targeting CD19 with budoprutug may be a compelling approach in the treatment of pMN.”

“These initial PrisMN results build on our Phase 1b findings, demonstrating early immunologic activity at 200 mg and the potential for increased activity at higher doses,” said Aoife Brennan, M.B., Ch.B., President and Chief Executive Officer of Climb Bio. “The observed pharmacokinetics confirm that patients with pMN have increased clearance of budoprutug compared to patients who do not have proteinuria. We are encouraged by the greater exposure and deeper B-cell depletion we are seeing at these early time points in the 600 mg cohort. As enrollment and follow-up continue, we look forward to sharing additional data. Beyond pMN, we are encouraged by the sustained steroid-free remission reported in the MCD case, supporting further investigation of budoprutug in additional glomerular diseases and highlighting its potential impact across different B-cell mediated diseases.”

Key highlights from the oral presentation:

• Early immunologic activity at 200 mg
  • Mean PLA2R antibody reduction of 70% at Week 12; five of 13 patients (38%) achieved immunologic remission. Mean reduction of 80% at Week 12 for patients with baseline PLA2R antibody (Ab) <175 RU/mL
  • Phase 2 Week 12 data consistent with Phase 1b Week 12 data across B-cell depletion, anti-PLA2R antibody reduction, and immunologic remission rate
• Population PK analysis and emerging 600 mg data support the evaluation of higher doses
  • Population PK analysis completed across all budoprutug studies (n≈120) found that patients with high proteinuria (median UPCR of 6.8 g/g) clear budoprutug ≥2-fold faster than non-proteinuric individuals, supporting the use of higher doses in pMN
  • Mean peripheral CD20+ B-cell suppression at Week 4 was 98% at 600 mg, compared with 74% at 200 mg
• Safety and tolerability
  • Budoprutug was generally well tolerated in the 200 mg and 600 mg cohorts
  • Most adverse events were mild to moderate (Grade 1 or 2), with no treatment-related serious adverse events, adverse events leading to treatment discontinuation, or deaths reported

Following the oral presentation at 5:30 p.m. MT., the presentation and poster will be available on the Pipeline & Science—Publications page of the Company’s website here.

About Primary Membranous Nephropathy (pMN)
Primary membranous nephropathy is an autoantibody mediated disease characterized by proteinuria, nephrotic syndrome, and progressive loss of renal function. Patients with uncontrolled disease may develop chronic kidney disease or end-stage kidney disease, requiring dialysis or transplantation. There are about 75,000 people in the U.S. living with pMN. Currently, there are no FDA approved therapies for pMN.

About Climb Bio, Inc.
Climb Bio, Inc. is a clinical-stage biotechnology company with a mission to deliver high impact, disease-modifying medicines for individuals living with immune-mediated diseases, including those affecting kidney health. The Company’s pipeline includes, budoprutug, an anti-CD19 monoclonal antibody that has potential to treat a broad range of B-cell mediated diseases, and CLYM116, an anti-APRIL monoclonal antibody being developed for IgA nephropathy. For more information, please visit climbbio.com. 

About Budoprutug
Budoprutug is a clinical-stage, anti-CD19 monoclonal antibody with the potential to address a broad range of B-cell mediated, immune-driven diseases. Designed with enhanced effector function and low picomolar affinity, budoprutug targets and depletes CD19-expressing B cells, including plasmablasts and certain plasma cells, key sources of pathogenic autoantibodies. Early clinical data suggest budoprutug may offer durable B-cell depletion, rapid reductions in autoantibodies, and clinical remission in primary membranous nephropathy (pMN). Budoprutug is being evaluated in clinical trials for pMN, immune thrombocytopenia (ITP), and systemic lupus erythematosus (SLE). A subcutaneous formulation is also in development to enable broader patient access. Budoprutug has been granted Orphan Drug Designation and Fast Track Designation by the FDA for the treatment of pMN.

Forward-Looking Statements
This press release contains “forward-looking statements” including, without limitation, statements regarding: future expectations, plans and prospects for Climb Bio; expectations regarding the therapeutic benefits, clinical potential and clinical development of budoprutug; the anticipated timelines for announcing data from Climb Bio’s ongoing and planned clinical trials; the anticipated timelines for enrolling patients in planned clinical trials; and other statements containing the words “anticipate,” “continue,” “could,” “expect,” “intend,” “may,” “plan,” “potential,” “should,” “suggest,” “target,” “will” and similar expressions. Forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. Climb Bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. These risks and uncertainties include, but are not limited to, important risks and uncertainties associated with: the ability of Climb Bio to timely and successfully achieve or recognize the anticipated benefits of its technology transfer and exclusive license agreement with Mabworks; Climb Bio’s ability to advance budoprutug and CLYM116 on the timelines expected or at all and to obtain and maintain necessary approvals from the U.S. Food and Drug Administration and other regulatory authorities; obtaining and maintaining the necessary approvals from investigational review boards at clinical trial sites and independent data safety monitoring boards; replicating in clinical trials positive results found in early-stage clinical trials or nonclinical studies; competing successfully with other companies that are seeking to develop treatments for primary membranous nephropathy, immune thrombocytopenia, systemic lupus erythematosus, IgA nephropathy and other immune-mediated diseases; maintaining or protecting intellectual property rights related to budoprutug, CLYM116 and/or its other product candidates; managing expenses; changes in applicable laws or regulations; the possibility that Climb Bio may be adversely affected by other economic, business and/or competitive factors; and raising the substantial additional capital needed, on the timeline necessary, to continue development of budoprutug, CLYM116 and any other product candidates Climb Bio may develop. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Climb Bio’s actual results to differ materially from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in Climb Bio’s most recent filings with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Climb Bio’s views as of the date hereof and should not be relied upon as representing Climb Bio’s views as of any date subsequent to the date hereof. Climb Bio anticipates that subsequent events and developments will cause Climb Bio’s views to change. However, while Climb Bio may elect to update these forward-looking statements at some point in the future, Climb Bio specifically disclaims any obligation to do so, except as required by law.

Investors and Media
Carlo Tanzi, Ph.D.
Kendall Investor Relations
ctanzi@kendallir.com

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