Market Newsdesk

• TeLuRide-005, a Phase 2 trial of EIK1001 in first-line patients with stage 4 NSCLC completed enrollment of both non-squamous and squamous cohorts and reports updated rates of response and disease control, strengthening the case for continued development
• Phase 1/2 trial of EIK1003 reports updated safety and efficacy monotherapy data and initial combination data with weekly paclitaxel in patients with advanced solid tumors

MILLBRAE, Calif., May 30, 2026 (GLOBE NEWSWIRE) — Eikon Therapeutics, Inc. (Nasdaq: EIKN) (Eikon), a late-stage clinical biopharmaceutical company dedicated to developing innovative medicines to address serious unmet medical needs, today announced presentations on several of its lead programs at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, including updated data for its EIK1001 trial in non-small cell lung cancer (NSCLC) and its highly selective PARP1 inhibitor EIK1003.

“We are pleased to present six abstracts at ASCO reflecting both the progress of our pipeline and the growing body of evidence supporting our lead programs,” said Roy Baynes, M.D., Ph.D., Chief Medical Officer of Eikon. “In our most advanced program, EIK1001 demonstrated encouraging response rates and durability in combination with standard of care in first-line NSCLC. We also observed meaningful clinical activity of EIK1003 both as a monotherapy and, potentially a first for the field, in combination with paclitaxel, including responses in heavily pretreated patients. Together, these data continue to reinforce the scientific rationale behind our programs and their potential to deliver meaningful benefit to people living with cancer.”

EIK1001 Clinical Update.

Updated data from our ongoing Phase 2 trial evaluating the safety and tolerability of EIK1001 in combination with both pembrolizumab and histology appropriate chemotherapy for the front-line treatment of patients with advanced NSCLC, also known as our TeLuRide-005 trial, provide evidence of a potentially durable effect of EIK1001 in combination with standard of care, and a preliminary tolerability profile supportive of systemic administration in an out-patient setting, a potential key differentiator of EIK1001 from previous TLR7/8 targeted therapies.

EIK1001 is an investigational, systemically administered dual-agonist of Toll-like receptors 7 and 8 designed to stimulate both innate and adaptive immune responses. In Phase 1 trials of EIK1001, single-agent activity was observed in patients with advanced malignancy. This mechanism may complement the antitumor immune response engendered by PD-(L)1 blockade.

TeLuRide-005 is our multicenter, open-label trial of once-weekly (QW) systemically administered EIK1001 in combination with standard of care, once every third week (Q3W) pembrolizumab and histology appropriate chemotherapy in first-line, treatment-naïve patients with stage 4 NSCLC. Enrollment completed in the first quarter of 2026.

As of enrollment cutoff, 72 participants with previously untreated stage 4 NSCLC received intravenous EIK1001 QW combined with standard of care pembrolizumab plus chemotherapy Q3W. After 8 cycles, EIK1001 administration was reduced to Q3W. The maximum treatment duration is 2 years (up to 35 cycles) for EIK1001 in combination with pembrolizumab, with pemetrexed continued at the discretion of the Investigator for non-squamous patients.

At the March 17, 2026 safety data cutoff, among the safety evaluable population (n=72: 39 non-squamous; 33 squamous), the combination of EIK1001 with pembrolizumab and chemotherapy was generally well tolerated, with an adverse event (AE) profile similar to standard of care alone. Most treatment-emergent adverse events (TEAEs) were Grade 1-2, and the most common Grade 3 or higher treatment-related adverse events (TRAEs) were neutropenia (30.6%), anemia (9.7%), and thrombocytopenia (9.7%). All cytokine release syndrome (CRS) AEs were Grade 1 and 2, and all CRS events occurred before Cycle 4 in all but one patient. This profile was sufficient to support administration in an out-patient setting during the ongoing trial.

Among the efficacy-evaluable population (n=65: 36 non-squamous; 29 squamous), EIK1001 treatment in combination with pembrolizumab and chemotherapy resulted in a 63.1% objective response rate (ORR) and 90.8% disease control rate (DCR) at the efficacy data cutoff of May 4, 2026. Among participants in the non-squamous cohort, an ORR of 55.6% and a DCR of 83.3% were observed, respectively, with a median follow-up of 13.6 months. The median duration of response (DOR) in the non-squamous cohort was greater than 11 months at the efficacy data cutoff. Among participants in the squamous cohort, for which the data set was still maturing at the data cutoff due to slower enrollment, an ORR of 72.4% and a DCR of 100% were observed, respectively, with a median follow-up of 8.8 months.

EIK1003 Clinical Update.

Updated data from EIK1003-001, our Phase 1/2 trial evaluating the safety and efficacy of EIK1003 as monotherapy or in combination with anti-cancer agents in participants with advanced solid tumors, demonstrate that EIK1003 monotherapy (Cohort 1A) was generally well-tolerated across multiple dose levels. In Cohort 1C, signals of antitumor activity were observed with EIK1003 in combination with weekly paclitaxel, with a combination safety profile consistent with paclitaxel’s known toxicities. These data support what appears to be a unique profile for EIK1003 in combination strategies within the evolving PARP inhibitor landscape.

EIK1003 is an investigational, highly-selective PARP1 inhibitor designed to leave PARP2 signaling intact. PARP2 inhibition may be a key driver of the hematological toxicity associated with first generation, non-selective PARP inhibitors.

Cohort 1A: Updated EIK1003 Monotherapy Data

As of the enrollment cutoff, 65 patients with breast, ovarian, prostate, or pancreatic cancer have been treated in Cohort 1A with EIK1003 monotherapy at doses ranging from 10mg to 160mg once daily (QD), using a Bayesian optimal interval dose-escalation design to assess for safety, tolerability, pharmacokinetics and antitumor activity. This represents an expansion of the dataset previously presented at ASCO 2025, with additional patients enrolled and longer follow-up.

At the February 27, 2026 safety data cutoff, the updated safety profile in Cohort 1A remained generally consistent with data previously presented at ASCO 2025. Treatment-emergent adverse events (TEAEs) were reported in 63 of 65 patients (96.9%). Grade 3 or higher TEAEs occurred in 29 patients (44.6%); the most common were anemia (9.2%), neutropenia (7.7%), and ascites (7.7%). 4 of the 6 patients who developed Grade 3 or higher anemia had Grade 1-2 anemia at study entry. TEAEs led to dose reductions in 7 patients (10.8%) and to treatment discontinuation in 6 patients (9.2%). No TRAEs leading to death were reported.

Among efficacy-evaluable patients in Cohort 1A (n=49), ORR was 14.3% overall and 26.7% in PARP-naïve patients. Objective responses by tumor type were 14.8% (4/27) in ovarian cancer, 12.5% (2/16) in breast cancer, and one patient with prostate cancer. Median duration of response among confirmed responders (n=5) was 7.8 months at the efficacy data cutoff of May 4, 2026.

Cohort 1C: Initial Data on EIK1003 in Combination with Weekly Paclitaxel

As of the February 27, 2026 safety data cutoff, 60 patients with platinum-resistant ovarian cancer or HER2-negative breast cancer that failed chemotherapy or hormonal therapy have been treated in Cohort 1C with EIK1003 at doses ranging from 10mg to 60mg QD in combination with paclitaxel 80 mg/m² IV QW. Dose-limiting toxicities of febrile neutropenia and tachycardia were reported in one patient each at the highest dose level tested, 60mg. TEAEs were reported in 60 out of 60 patients (100%). Grade 3 or higher TEAEs occurred in 45 patients (75%); the most common were neutropenia (50%) and anemia (13.3%). Neutropenia is a known and expected adverse event associated with weekly paclitaxel chemotherapy. All 8 patients who developed Grade 3 or higher anemia had Grade 1-2 anemia at study entry. TEAEs led to dose reductions in 15 patients (25%) and discontinuation of one or both study drugs in 11 patients (18.3%). No TRAEs leading to death were reported.

Among efficacy-evaluable patients in Cohort 1C (n=53), ORR was 24.5%; 12 of 13 responders (92%) had received prior taxane therapy. Objective responses by tumor type were 29.6% (8/27) in platinum-resistant ovarian cancer and 19.2% (5/26) in breast cancer. Duration of response among confirmed responders (n=9) ranged from 1.5 to 11.4 months, with responses ongoing in 3 responders at the efficacy data cutoff of May 4, 2026.

2026 ASCO Abstract Titles.

EIK1001

Title:
Efficacy, safety and cytokine profiling with addition of the toll-like receptor (TLR) 7/8 dual agonist EIK1001 to Standard of Care First-Line Therapy: the Phase 2 TeLuRide-005 trial in Stage 4 Non-Small Cell Lung Cancer

Title:
Adaptive Phase 2/3 Study of EIK1001, a TLR7/8 Dual Agonist, in Combination with Pembrolizumab, as First-Line Therapy in Participants with Advanced Melanoma (TeLuRide-006)

Title:
A Phase 2/3 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapy in Participants with Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008)

EIK1003

Title:
EIK1003, a PARP1-selective inhibitor, in combination with paclitaxel (PTX): Initial combination and updated monotherapy results from a Phase 1/2 study EIK1003-001 in advanced solid tumors

EIK1005

Title:
First-in-Human Study to Evaluate the Safety, Tolerability, and PK of EIK1005, a Novel WRN Inhibitor in Healthy Participants

Title:
Phase 1/2 Study of the novel Werner helicase inhibitor EIK1005 as Monotherapy and in Combination with Pembrolizumab in Patients with Advanced Solid Tumors, including MSI-H or dMMR Tumors (Publication only)

Copies of the 2026 ASCO presentations will be made available on our website: www.eikontx.com under Scientific Papers & Publications.

About Eikon Therapeutics

Eikon is a late-stage clinical biopharmaceutical company dedicated to building a global, fully-integrated organization developing innovative medicines to address serious unmet medical needs. Eikon’s initial focus is oncology, where it is advancing a pipeline of drug candidates targeting areas of high unmet need that could eventually become critical medicines for the treatment of various cancers. Eikon deploys its technology platform, including its proprietary single molecule tracking system, to develop internally-derived novel therapies, while also leveraging the deep expertise of its management team to in-license promising assets. Eikon’s vision is to become a generational leader, by purposefully integrating traditional biology research with advanced engineering to develop better medicines faster. For more information, visit www.eikontx.com.

Forward-Looking/Safe Harbor Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements in this press release that are not historical facts are hereby identified as forward-looking statements for this purpose. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the therapeutic potential, safety, and efficacy of Eikon’s product candidates; the timing for anticipated data readouts; expected milestones and business objectives for 2026 and beyond, including Eikon’s anticipated presentations at the ASCO Annual Meeting; and other statements regarding Eikon’s future operations, financial performance, financial position, prospects, objectives, strategies and other future events.

These forward-looking statements are based upon management’s current expectations and assumptions, and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: our limited operating history; our significant net losses incurred since inception and the likelihood of incurring additional losses for the foreseeable future; our need for substantial additional funding; the early stage of development of many of our product candidates and the possibility that our product candidates may fail in development; our dependence on the success of our current product candidates; our ability to leverage our technology platform to enable more informed drug research and development; legal and regulatory risks; intellectual property-related risks; and those risks, uncertainties and other factors discussed under the caption “Risk Factors” and elsewhere in Eikon’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the Securities and Exchange Commission (“SEC”) on May 11, 2026, and in other public filings with the SEC in the future.

As a result, you should not place undue reliance on any forward-looking statements. The forward-looking statements made in this press release speak only as of the date of this press release, and Eikon undertakes no obligation to update such forward-looking statements, whether as a result of new information, future developments or otherwise, except as required by law.

Contacts:

Investors

Alfred “Freddie” Bowie, Ph.D., CFO
[email protected]

Media

Colin Sanford
[email protected]

• First investigational PD-(L)1xVEGF bispecific immunomodulator to present global data showing encouraging efficacy in combination with chemotherapy in first-line non-small cell lung cancer across PD-L1 expression levels and subtypes, highlighting its potential to set a new standard of care
• Pumitamig plus chemotherapy showed robust and consistent antitumor activity in first-line non-small cell lung cancer at both evaluated dose levels, with higher confirmed objective response rates at the lower dose of 63.6% in the non-squamous and 72.7% in the squamous subtypes
• Pumitamig is advancing through a comprehensive global Phase 3 development program in non-small cell lung cancer, including the actively enrolling pivotal Phase 3 part of the ROSETTA Lung-02 trial, along with two additional global Phase 3 trials

MAINZ, Germany, and PRINCETON, USA, May 30, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Bristol Myers Squibb Company (NYSE: BMY, “BMS”) today announced interim Phase 2 data from the global Phase 2/3 ROSETTA Lung-02 clinical trial (NCT06712316) evaluating the investigational PD-L1xVEGF-A bispecific immunomodulator pumitamig (also known as BNT327 or BMS-986545) plus chemotherapy in patients with previously untreated advanced non-small cell lung cancer (“NSCLC”).

The data showed encouraging anti-tumor activity, with high response rates observed in both non-squamous and squamous NSCLC and at each PD-L1 expression level (TPS ˂ 1%, TPS 1 – 49%, and TPS ≥ 50%). The data are being presented today as a rapid oral presentation (abstract #8513) at the 2026 American Society of Clinical Oncology (“ASCO”) Annual Meeting in Chicago.

“Despite significant immuno-oncology advances in the treatment of  non-small cell lung cancer, most advanced diseases relapse on or after a PD-(L)1 checkpoint inhibitor treatment,¹ indicating that targeting this immunologic pathway alone is insufficient to achieve durable responses,” said Solange Peters, M.D., Ph.D., Lead Investigator and Director of Oncology at the University Hospital of Lausanne, Switzerland. “I am encouraged by the efficacy signal with this bispecific approach, showing robust responses across subtypes and PD-L1 levels, supporting the continued investigation of pumitamig and its potential to deliver improved outcomes for a broad range of patients with NSCLC.”

The Phase 2 part of the ROSETTA Lung-02 trial evaluated pumitamig in two dose levels, in combination with chemotherapy. At this interim analysis at the April 13, 2026 data cut-off, among 40 response-evaluable patients with a median follow-up of 9.0 months, pumitamig plus chemotherapy showed a confirmed objective response rate (“cORR”) of 57.1% in patients with non-squamous NSCLC and 68.4% with squamous NSCLC with a disease control rate (“DCR”) of 100%. Encouraging anti-tumor activity was observed at both dose levels, with higher response rates at the lower dose showing a cORR of 63.6% for non-squamous and 72.7% for squamous NSCLC. Results were high at each PD-L1 expression level (cORR: 47.6% TPS ˂ 1%; 77.8% TPS 1 – 49 %; 100% TPS ≥ 50%).

Pumitamig plus chemotherapy demonstrated a manageable safety profile with a low discontinuation rate. Grade ≥ 3 treatment-related adverse events (“TRAEs”) were reported in 48.8% of patients and were considered pumitamig-related in 23.3%, leading to treatment discontinuation in four (9.3%) patients. Immune-related AEs (“irAEs”) occurred in 16 (37.2%) patients and grade ≥ 3 irAEs in two (4.7%) patients. Bleeding events were reported in nine (20.9%) patients, with only one event being grade 3.

“The data we are presenting today provide further evidence of the potential of pumitamig to enhance anti-tumor responses in advanced lung cancer, one of the most challenging indications, by simultaneously targeting PD-L1 and VEGF-A with a single molecule,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “Pumitamig has consistently shown efficacy in three global Phase 2 trials across PD-L1 expression levels. Together with our partner BMS, we are continuing to advance pumitamig in ongoing pivotal and novel-novel combination trials with the goal of delivering better outcomes for more patients.”

“We are committed to advancing the science of lung cancer with pumitamig and improving on the standard of care for people with this challenging disease,” said Anne Kerber, Senior Vice President, Head of Development, Hematology, Oncology, Cell Therapy at Bristol Myers Squibb. “With one of the broadest registrational programs in the class, we are focused on accelerating the development of pumitamig together with BioNTech, with the goal of delivering meaningful benefit to patients, including those who have been left behind by current therapies.”

BioNTech and BMS are advancing a broad development plan for pumitamig in non-small cell lung cancer across disease stages and subgroups. In addition to the ongoing global ROSETTA Lung-02 trial, which is currently recruiting for the Phase 3 part of the trial, there are two additional global Phase 3 clinical trials in NSCLC currently enrolling. These include ROSETTA Lung-201 (NCT07361497), evaluating pumitamig compared to durvalumab following concurrent chemoradiation therapy in patients with unresectable stage III NSCLC; and ROSETTA Lung-202 (NCT07361510), evaluating pumitamig compared to pembrolizumab as a first-line treatment for patients with advanced PD-L1 ≥ 50% NSCLC. Pumitamig is also being investigated in combination with other novel investigative treatments for NSCLC, including in combination with investigational antibody-drug conjugates (“ADCs”) and other modalities.

About ROSETTA Lung-02

The global Phase 2/3 ROSETTA Lung-02 trial (NCT06712316) is evaluating pumitamig (BNT327/ BMS986545) in combination with chemotherapy in patients with first-line treatment of non-squamous and squamous non-small cell lung cancer without actionable genomic alterations and with any level of PD-L1 expression. In the Phase 2 dose-optimization part of the trial, patients were randomized 1:1 to 1400 mg or 2000 mg pumitamig plus histology-specific chemotherapy Q3W (non-squamous: carboplatin + pemetrexed; squamous: carboplatin + paclitaxel). The primary endpoints of the Phase 2 part of the trial are objective response rate (ORR) per investigator’s assessment (RECIST 1.1), best percentage change in tumor size from baseline, and safety. Key secondary endpoints include duration of response (DOR) and disease control rate (DCR). The Phase 3 part of the trial will evaluate pumitamig plus chemotherapy versus pembrolizumab plus chemotherapy. Based on the totality of the data, a pumitamig 1500 mg flat dose Q3W plus chemotherapy was selected for further evaluation in the Phase 3 part. The primary endpoint of the Phase 3 part of the trial is progression free survival (PFS) assessed by blinded independent central review (BICR). Key secondary endpoints include overall survival (OS), ORR, DOR.

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 2,000 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 March 31, 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: Transforming Patients’ Lives Through Science

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 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

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Investor Relations

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1. Mariniello A et al. BioDrugs, 2025 Feb 15;39(2):215–235.
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. 

– Post hoc analysis from pivotal Launch-HTN trial shows statistically significant and clinically meaningful reductions in blood pressure in participants with chronic kidney disease –

– In participants with chronic kidney disease and baseline albuminuria, lorundrostat significantly reduced urine albumin-to-creatinine ratio –

– Lorundrostat demonstrated a favorable safety profile in participants with and without chronic kidney disease over 12 weeks –

RADNOR, Pa., May 30, 2026 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today presented new clinical data for lorundrostat at the 35th European Meeting on Hypertension and Cardiovascular Protection (ESH 2026) in Gdańsk, Poland.

“Despite the availability of current therapies, up to 75 percent of patients with chronic kidney disease still have uncontrolled or resistant blood pressure, contributing to a high risk of cardiovascular events and kidney disease progression,” said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “These results, together with our Explore-CKD trial findings, demonstrate lorundrostat’s potential to address the compounded burden of hypertension and CKD, underscoring its promise as an important potential treatment option for this difficult-to-treat population with high unmet need.”

The analysis evaluated the efficacy and safety of once-daily lorundrostat 50 mg by CKD status among 800 participants with uncontrolled or resistant hypertension enrolled in the randomized, double-blind, placebo-controlled Phase 3 Launch-HTN trial. Among participants with CKD (n=192), 71% were receiving three or more anti-hypertensive medications at baseline, compared with 56% of those without CKD. In addition, 31% of participants with CKD had systolic blood pressure (SBP) ≥160 mmHg at baseline, versus 17% of participants without CKD.

Lorundrostat demonstrated significant reductions in SBP that were comparable between CKD and non-CKD participants. At week 12, placebo-adjusted SBP reductions were 9.6 mmHg in participants with CKD (p=0.0022) and 12.2 mmHg in those without CKD (p<0.0001). A greater proportion of lorundrostat-treated participants also achieved target SBP of <130 mmHg at week 12 compared with placebo, both among CKD participants (44% vs 18%) and non-CKD participants (48% vs 22%).

Lorundrostat treatment was also associated with a significant placebo-adjusted reduction in urinary albumin-to-creatinine ratio (UACR) among 84 participants with CKD and baseline albuminuria, achieving a 52.2% placebo-adjusted reduction at 12 weeks (p<0.0001). Lorundrostat had a favorable safety profile in both CKD and non-CKD participants with low rates of confirmed hyperkalemia, 2.4% and 0% respectively.

“These findings are compelling because they show that lorundrostat achieves comparable blood pressure reductions regardless of kidney disease status, while also significantly reducing albuminuria, a key marker of kidney injury and disease progression, in these patients,” said Dr. Liffert Vogt, Professor of Nephrology and Renal Transplantation at Amsterdam University Medical Center and University of Amsterdam. “Aldosterone is a key driver of both chronic kidney disease and difficult-to-treat hypertension, and these findings demonstrate the potential for lorundrostat to provide needed cardiorenal protection for these patients.”

Previous data from the Explore-CKD trial, presented at ASN Kidney Week 2025, showed that adding lorundrostat to standard-of-care therapy reduced both blood pressure and albuminuria in participants with hypertension and CKD. Across both the Launch-HTN and Explore-CKD trials, lorundrostat demonstrated clinically meaningful blood pressure reductions in participants with hypertension, including those in high-risk populations with CKD, obesity and Black or African American participants.

Lorundrostat is currently under review by the U.S. Food and Drug Administration, with a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026.

About Launch-HTN 

Launch-HTN (NCT06153693) was a global, randomized Phase 3 double-blind, placebo-controlled trial of adults whose blood pressure remained uncontrolled despite being on two to five antihypertensive medications. Participants were assigned to one of three groups: placebo; lorundrostat 50 mg once daily; or lorundrostat 50 mg once daily with the option to increase to 100 mg at week six. The primary endpoint was change from baseline in SBP at 6 weeks versus placebo, measured by automated office blood pressure monitoring.

About Chronic Kidney Disease (CKD)

CKD, which is characterized by the gradual loss of kidney function, is estimated to affect more than 10% of the global population and is one of the leading causes of mortality worldwide. According to the U.S. Centers for Disease Control and Prevention (CDC), more than 1 in 10 of adults aged 18 or older (37 million people) are estimated to have CKD. Approximately 21% of adults with high blood pressure are estimated to have CKD. The relationship between these conditions is tightly linked: sustained hypertension may contribute to impaired kidney function, and progressive decrease in kidney function may lead to worsening blood pressure (BP) control. When CKD is present in patients with hypertension, the risk of cardiovascular disease and mortality rises significantly.

Emerging evidence points to dysregulated aldosterone as a key driver of both diseases. Excess aldosterone promotes sodium retention, vascular inflammation and fibrosis, contributing to both uncontrolled BP and kidney injury. Despite the availability of existing therapies, a significant proportion of patients remain uncontrolled or undertreated. Early detection and targeted interventions that address underlying mechanisms, such as aldosterone dysregulation, may offer the potential to slow CKD progression, reduce cardiovascular risk and improve long-term outcomes. Without effective management, CKD can advance to kidney failure, requiring dialysis or transplantation.

About Hypertension

Having sustained, elevated blood pressure (BP) (or hypertension) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the United States. In 2022, more than 685,000 deaths in the United States included hypertension as a primary or contributing cause. Hypertension and related health issues resulted in an estimated annual economic burden of about $219 billion in the United States in 2019.

Less than 50% of hypertensive patients achieve their BP goal with currently available medications. Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 30% of all hypertensive patients.

About Lorundrostat

Lorundrostat is an investigational, proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as related comorbidities, such as CKD, OSA and other diseases driven by dysregulated aldosterone. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated a 40-70% reduction in plasma aldosterone concentration in hypertensive participants.

Mineralys has now completed six late-stage clinical trials of lorundrostat supporting the efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN. This includes two pivotal, registrational trials, the Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, which support the robust, durable and clinically meaningful reductions in systolic BP by lorundrostat. Lorundrostat was generally well tolerated in both trials with a favorable safety profile.

About Mineralys

Mineralys Therapeutics is a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is an investigational, proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky.

Forward-Looking Statements

Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat; the anticipated timing of the U.S. Food and Drug Administration’s (FDA) review of our accepted New Drug Application (NDA) and any subsequent regulatory approval of lorundrostat; and the planned future clinical development of lorundrostat and the timing thereof. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: topline results that we report are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; any delays in the FDA’s review of our accepted NDA, including as a result of a government shutdown or reductions in agency funding or personnel, the results of our clinical trials, including the Advance-HTN and Launch-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for regulatory approval of lorundrostat; later developments with the FDA may be inconsistent with the feedback from prior meetings, including whether the proposed pivotal program will support registration of lorundrostat following the FDA’s review of our NDA submission; our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs and other trade policies, and the potential for a local and/or global economic recession; our ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; our reliance on our exclusive license with Tanabe Pharma Corporation to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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Melyssa Weible
Elixir Health Public Relations
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