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Cogent Biosciences Reports Recent Business Highlights and First Quarter 2026 Financial Results

On May 5, 2026 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported a business update and announced financial results for the first quarter ended March 31, 2026.

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"2026 is shaping up to be a pivotal year for Cogent," said Andrew Robbins, Cogent’s President and Chief Executive Officer. "We have two NDAs for bezuclastinib under FDA review and expect to submit a third in the first half of this year. These milestones highlight the breadth of bezuclastinib’s potential across GIST and KIT-driven diseases. With a strong balance sheet, we are focused on completing our commercial build and preparing for multiple potential launches."

Recent Business Highlights

Announced details for an oral presentation on May 30 at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting featuring pivotal data from the Phase 3 PEAK trial in patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib

Presented updated preclinical data from the company’s KRAS and ErbB2 candidates at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting

Announced submission of the company’s New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in patients with GIST who have received prior treatment with imatinib. Based on the positive results from the PEAK trial, the bezuclastinib NDA was submitted under the FDA’s Real-Time Oncology Review (RTOR) program, which is intended to enable a more streamlined review process. Bezuclastinib was also granted Breakthrough Therapy Designation as a treatment for GIST earlier in 2026.

Announced the FDA accepted its NDA for bezuclastinib in patients with NonAdvanced Systemic Mastocytosis (NonAdvSM) and assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2026

Presented six posters with bezuclastinib in patients with NonAdvSM at the 2026 AAAAI annual meeting

Initiated Phase 1 studies for both CGT4255, a novel, selective, brain-penetrant ErbB2 inhibitor and CGT6297, a novel, selective and potential best-in-class PI3Kα inhibitor

Upcoming Milestones

Bezuclastinib

Submit the APEX NDA in the first half of 2026 for bezuclastinib in patients with Advanced Systemic Mastocytosis (AdvSM)

Present detailed clinical data from the Phase 3 PEAK pivotal trial at the 2026 ASCO (Free ASCO Whitepaper) annual meeting and from the APEX pivotal trial in the first half of 2026

Initiate a Phase 2 trial in the first half of 2026 investigating the benefit of the bezuclastinib plus sunitinib combination for first-line GIST patients with exon 9 mutations who are naive to, or recently initiated treatment with, imatinib

Pending FDA approval(s), launch bezuclastinib in the second half of 2026

Pipeline

Submit Investigational New Drug (IND) applications for CGT1815, Cogent’s novel, selective pan-KRAS(ON) inhibitor and CGT1145, Cogent’s novel, selective JAK2 V617F inhibitor

Complete dose escalation for CGT4255, Cogent’s CNS-penetrant, selective mutant ErbB2 inhibitor

Bezuclastinib – Expanded Access Program

Working with the FDA, Cogent has established active Expanded Access Programs (EAPs) for U.S. patients with GIST or SM who meet disease-specific criteria and could benefit from treatment with bezuclastinib or the combination of bezuclastinib and sunitinib. For more information please visit: View Source

Upcoming Investor Conference

Jefferies Healthcare Conference on June 3 at 11:05 a.m. ET.
A live webcast can be accessed on the Investors & Media page of Cogent’s website at investors.cogentbio.com/events. A replay will be available approximately two hours after completion of the event and will be archived for up to 30 days.

First Quarter 2026 Financial Results

Cash and Cash Equivalents: As of March 31, 2026, cash, cash equivalents and marketable securities were $866.4 million, which includes net proceeds of $45.7 million from shares recently sold under the Company’s at-the-market (ATM) stock offering as well as non-recurring payments totaling $18.0 million related to annual performance-based bonus compensation and a milestone payment to Plexxikon. Based on our current plans, we expect our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into 2028, including the commercialization of bezuclastinib in SM and GIST.

R&D Expenses: Research and development expenses were $75.4 million for the first quarter of 2026 compared to $63.0 million for the first quarter of 2025. The increase was driven by increased early-stage, preclinical and discovery programs as we advance our pipeline of programs into Phase 1 clinical trials and IND-enabling studies, and includes one-time costs associated with the wind down of the FGFR clinical program. R&D expenses include non-cash stock compensation expense of $8.9 million for the first quarter of 2026 as compared to $5.3 million for the first quarter of 2025.

G&A Expenses: General and administrative expenses were $28.2 million for the first quarter of 2026 compared to $11.9 million for the first quarter of 2025. The increase was primarily due to the growth of the organization and activities related to the anticipated commercial launch of bezuclastinib. G&A expenses include non-cash stock compensation expense of $8.0 million for the first quarter of 2026 as compared to $4.8 million for the first quarter of 2025.

Net Loss: Net loss was $97.4 million for the first quarter of 2026 compared to a net loss of $72.0 million for the first quarter of 2025.

Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Cogent also announced today that, on April 29, 2026, the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, approved the grants of "inducement" equity awards to seven new employees under the company’s 2020 Inducement Plan with a grant date of April 29, 2026. The awards were approved in accordance with Listing Rule 5635(c)(4) of the corporate governance rules of the Nasdaq Stock Market. The employees received, in the aggregate, (i) nonqualified options to purchase 62,600 shares of Cogent common stock and (ii) 48,600 restricted stock units (RSUs). Each option has a 10-year term, an exercise price equal to the closing price of Cogent’s common stock on the grant date, and a 4-year vesting schedule with 25% vesting on the 1-year anniversary of the grant date and the remainder vesting in equal monthly installments over the subsequent 36 months, provided such employee remains employed through each such vesting date. The RSUs vest annually in equal installments over 4 years from the grant date, provided such employee remains employed through each such vesting date.

(Press release, Cogent Biosciences, MAY 5, 2026, View Source [SID1234665111])

CiMaas and India based East Ocyon Bio sign collaboration agreement

On May 5, 2026 CiMaas BV reported that it has entered into a research collaboration with East Ocyon Bio, located in Gurugram, Haryana, India, an innovative company dedicated to developing optimally engineered natural killer (NK) cell and gamma delta T cell therapies to cure patients with cancer and autoimmune diseases.

Under the agreement, East Ocyon Bio will start testing the F012 feeder cell line created by CiMaas to support (CAR)-NK cell expansion from peripheral blood. East Ocyon Bio is the first partner in India using F012 feeder cells in their process with peripheral blood derived NK cells and is a validation by others of our techniques. Moreover, it will enable CiMaas to access the Indian market with innovative treatments for cancer patients and autoimmune diseases.

(Press release, CiMaas, MAY 5, 2026, View Source [SID1234665110])

Cellectar Biosciences Reports Positive 12-Month Follow-Up Data from Phase 2b CLOVER WaM Study Demonstrating Durable Responses and Efficacy of Iopofosine I 131 in r/r Waldenström Macroglobulinemia

On May 5, 2026 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of targeted oncology therapies, reported updated and mature 12-month follow-up data from its Phase 2b CLOVER WaM clinical trial evaluating iopofosine I 131 in patients with relapsed or refractory (r/r) Waldenström macroglobulinemia (WM). The updated dataset includes a minimum of 12 months of follow-up for all enrolled patients, as requested by the U.S. Food and Drug Administration (FDA), and the durability data presented here, further strengthen the previously reported efficacy results. The Company also reports subset analyses from CLOVER WaM showing iopofosine I 131 demonstrated strong and consistent efficacy in both BTKi-exposed and BTKi-refractory patients.

"The depth, durability, and consistency of responses observed across both the total population and BTKi-treated subsets underscore iopofosine’s potential as a meaningful new treatment option in WM and differentiate it from currently available therapies," said Jarrod Longcor, chief operating officer of Cellectar Biosciences. "With the completion of at least 12-month follow-up on all patients, we believe this dataset meets key regulatory expectations for an accelerated approval submission and positions us well as we advance toward initiating our confirmatory study."

Patients enrolled in the CLOVER WaM clinical trial had a median of four prior lines of therapy (range 2-15), with refractory rates running from 77% in Bruton tyrosine kinase inhibitors (BTKi)-exposed patients to 60% in chemotherapy-exposed patients and 58% in patients exposed to both BTKi and rituximab, making this one of the most heavily pretreated and refractory WM populations studied to date. Updated 12-month data demonstrated high response rates and sustained durability, supporting its accelerated regulatory pathway and potential role as a differentiated treatment option.

Summary of Efficacy Results in per Protocol Study Population (n=55):

Overall Response Rate (ORR): 83.6%
Major Response Rate (MRR): 61.8% (primary endpoint achieved)
Median Duration of Response (DoR): 17.8 months (secondary endpoint achieved)
Median Progression-Free Survival (PFS): 13.5 months
Very Good Partial Response/Complete Response Rate (VGPR/CR): 14.5%
Disease Control Rate (DCR): 98.2%
During the follow-up period, responses deepened and remained durable, underscoring the strength of the data, especially considering that treatment with iopofosine I 131 is a fixed-dosed regimen containing four ~30-minute infusions. This further highlights its potential for meaningful clinical benefit without the need for continuous therapy.

"These mature 12-month follow-up data, as required by the FDA, further strengthen the compelling clinical profile of iopofosine I 131," said James Caruso, president and chief executive officer. "Importantly, the durability of response continues to improve over time, and the consistency of activity in post-BTKi patients reinforces the potential of iopofosine to address a critical unmet need in the second line setting and beyond. We remain committed to providing iopofosine I 131 to the thousands of patients who can benefit from treatment and plan to initiate our confirmatory study in fourth quarter of this year."

Iopofosine I 131 continues to demonstrate a predictable and manageable safety profile:

Adverse events were transient and unlike other therapies approved for WM there were no significant bleeding events and low rates of infection (<10%)
Cytopenias were the most common treatment-emergent adverse events
Non-hematologic toxicities were primarily low grade (Grade <2)
Compelling Activity in BTKi-Exposed and Refractory Patients
BTKi therapies have become the standard of care in frontline treatment of WM, outcomes in post-BTKi patients are of increasing importance. Iopofosine I 131 demonstrated strong and consistent efficacy in both BTKi-exposed and BTKi-refractory patients, populations that are among the most difficult to treat.

Summary of Efficacy Results in BTKi-Exposed Patients (n=39):

MRR: 64.1%
Median DoR: 18.2 months
Median PFS: 15.9 months
Summary of Efficacy Results in BTKi-Refractory Patients (n=33):

MRR: 63.6%
Median DoR: 18.2 months
Median PFS: 14.8 months
These results demonstrate durability and depth of response comparable to, or exceeding, the overall study population, reinforcing the consistency of iopofosine’s activity across treatment-resistant subgroups. Furthermore, comparative assessments with published datasets suggest that iopofosine I 131 delivers superior efficacy across key endpoints relative to currently available salvage therapies in similar patient populations.

Efficacy and safety results from r/r WM patients treated with iopofosine I 131 immediately following BTKi therapy have been accepted for presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place from May 29-June 2, 2026 in Chicago, Illinois.

The company also plans to present the full data sets at upcoming medical congresses or scientific meetings.

About Accelerated Approval and Confirmatory Study Initiation
The CLOVER WaM dataset incorporates key elements aligned with regulatory expectations for accelerated approval, including:

Use of surrogate endpoints (MRR supported by DoR) reasonably likely to predict clinical benefit
Demonstration of durable responses in a high unmet need population
Completion of ≥12-month follow-up across all patients, as requested by the FDA
Cellectar is advancing plans to initiate a confirmatory randomized study in a post-first line, post-BTKi population. The study is expected to evaluate progression-free survival (PFS) as the primary endpoint, consistent with regulatory guidance.

The company is also preparing for potential regulatory submissions in the United States and Europe, supported by the strength and maturity of the CLOVER WaM dataset.

About Waldenstrom’s Macroglobulinemia
Waldenstrom’s Macroglobulinemia (WM) is a B-cell malignancy characterized by bone marrow infiltration with clonal lymphoplasmacytic cells that produce a monoclonal immunoglobulin M (IgM) that remains incurable with available treatments. The prevalence in the U.S. is approximately 26,000 with 1,500–1,900 patients being diagnosed annually. Approximately 11,500 patients require treatment in the relapsed or refractory setting and there are an estimated 4,700 patients requiring third line or greater therapy. There are also approximately 1,000 patients that have exhausted all current treatment options by third line because they are ineligible or intolerant to those existing therapies. Therefore, the total addressable market for third line or greater therapy is approximately 5,700 patients. There are no FDA- approved treatment options for patients progressing on BTKi therapy. BTKi therapies do not demonstrate complete response rates and require continuous treatment.

Non-FDA approved salvage treatments are used in more than 60% of patients. Over 50% of patients are treated with the same or similar treatment from prior lines of therapy. There is an established unmet need for new FDA-approved treatments, such as iopofosine I 131, that may provide a novel mechanism of action, increased deep durable responses, and time-limited treatment, especially in heavily pretreated WM patients.

(Press release, Cellectar Biosciences, MAY 5, 2026, View Source [SID1234665109])

Cellectar Biosciences Announces Oversubscribed Financing Up to $140 Million

On May 5, 2026 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of targeted oncology therapies, reported that it has entered into a securities purchase agreement with certain institutional investors, and an additional securities purchase agreement with certain members of management, to issue and sell up to an aggregate of approximately $35 million upfront and $105 million in milestone-based securities in a registered direct offering of common stock and a concurrent private placement of common stock, pre-funded warrants, and milestone-based warrants.

The oversubscribed financing was led by Nantahala Capital Management, with participation from Balyasny Asset Management, Caligan Partners, Janus Henderson Investors, SilverArc Capital Management, Stonepine Capital Management, Stempoint Capital LP, Empery Asset Management LP, and other dedicated healthcare funds along with members of the executive management team.

Ladenburg Thalmann & Co. Inc. acted as exclusive placement agent for the financing.

"We are highly encouraged by the strong demand for this financing and the support from a distinguished group of leading healthcare-focused investors who recognize both the urgent need for new treatment options for patients with Waldenström macroglobulinemia (WM) and the promise of iopofosine I 131," said James Caruso, president and chief executive officer of Cellectar Biosciences. "This oversubscribed financing provides important validation of our strategy to pursue accelerated approval in the US and conditional marketing approval in Europe for iopofosine, while supporting our plans to initiate a global confirmatory study in the fourth quarter of 2026. Importantly, this funding also underscores the strength of our proprietary Phospholipid Drug Conjugate (PDC) delivery platform and enables continued advancement of CLR 125, our differentiated Auger-emitting program for triple-negative breast cancer. Together, these efforts position us to deliver meaningful impact for patients with significant unmet medical needs while driving long-term value for our stakeholders."

In connection with the transaction, Andrew Gu of Nantahala Capital Management, LLC will join Cellectar’s Board of Directors upon closing.

Andrew Gu of Nantahala stated, "Waldenström macroglobulinemia is a rare hematologic malignancy, and Cellectar has built a meaningful body of clinical evidence for iopofosine I 131 across multiple Phase 2 studies in this patient population. I look forward to working with Jim and the team as a member of the Board."

Andrew Gu is an analyst at Nantahala, focused on investments in the biotechnology sector. Prior to joining Nantahala in 2021, Mr. Gu graduated from the University of Pennsylvania’s Roy and Diana Vagelos Life Sciences and Management (LSM) Program in 2021 with a B.S. in Economics (Finance concentration) from the Wharton School and a B.A. in Neuroscience from the College of Arts and Sciences. He was also a recipient of the Robert L. Benz and Marie Uberti-Benz Family Prize in Life Sciences and Management.

The registered direct offering involves the issuance and sale of 1,618,053 shares of common stock, $0.00001 par value per share (the "Common Stock") and the private placement involves the issuance and sale of (i) 2,116,887 shares of Common Stock, (ii) Pre-Funded Warrants to purchase 9,471,086 shares of Common Stock (the "Pre-Funded Warrants", and the shares issuable upon exercise of the Pre-Funded Warrants, the "Warrant Shares") and (iii) 13,206,026 each of milestone based Tranche A, Tranche B and Tranche C Warrants. The milestone warrants will be exercisable upon approval by the company’s stockholders, and are callable by the company upon the achievement of certain events and have the following terms:

Tranche A Warrant shall have a one-year term from the date of stockholder approval and have an exercise price of $2.65. The company may call the Tranche A Warrant after the initiation of the Randomized Confirmatory Pivotal Clinical Trial (defined as enrollment of the first patient in the study) for iopofosine I 131 and the price of the common stock exceeds 130% of the exercise price for 20 consecutive trading days.
Tranche B Warrant shall have a two-year term from the date of stockholder approval and have an exercise price of $2.65. The company may call the Tranche B Warrant for cash after the acceptance for review of the New Drug Application ("NDA") for iopofosine I 131 with the U.S. Food and Drug Administration (FDA) and the price of the common stock exceeds 130% of the exercise price for 20 consecutive trading days.
Tranche C Warrant shall have five-year term from the date of stockholder approval and have an exercise price of $2.65. The company may call the Tranche C Warrant for cash after the approval of the New Drug Application ("NDA") for iopofosine I 131 with the FDA and the price of the common stock exceeds 130% of the exercise price for 20 consecutive trading days.
Certain members of the executive management team of the Company have agreed to participate in the financing at a purchase price of $2.88 per share of Common Stock and accompanying milestone-based Tranche A, Tranche B and Tranche C Warrants with an exercise price of $2.88 per share. All other terms of the Warrants are identical to those being purchased by the Investors.

The shares Common Stock in the registered direct offering are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-279731) previously filed and declared effective by the Securities and Exchange Commission. The offering of such shares of Common Stock will be made only by means of a prospectus supplement that forms a part of the registration statement. The offer and sale of the foregoing securities in the private placement are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, such securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state.

(Press release, Cellectar Biosciences, MAY 5, 2026, View Source [SID1234665108])

BioNTech Announces First Quarter 2026 Financial Results and Corporate Update

On May 5, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported financial results for the three months ended March 31, 2026 and provided an update on its corporate progress.

"In the first quarter, we made substantial progress in executing towards our oncology strategy, highlighted by data presentations from our priority pan-tumor program pumitamig as well as our versatile antibody-drug conjugate portfolio. Simultaneously, we continue to broaden our clinical programs to include novel-novel combinations in order to inform the optimal set-up for registrational combination trials and maximize the potential of our pipeline," said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. "We will continue to focus on accelerating our key strategic programs as we remain steadfast in our vision to translate our science into survival for patients living with cancer."

Financial Review for First Quarter 2026

in millions €,
except per share data First Quarter 2026 First Quarter 2025
IFRS Results Adjusted Results2 IFRS Results Adjusted Results2
Revenues 118.1 118.1 182.8 182.8
Net loss (531.9) (494.6) (415.8) (430.8)
Diluted loss per share (2.10) (1.95) (1.73) (1.79)

Revenues for the first quarter of 2026 were €118.1 million, compared to €182.8 million for the comparative prior year period. The decrease was primarily driven by lower revenues of BioNTech’s COVID-19 vaccines.

Research and development ("R&D") expenses were €557.0 million for the first quarter of 2026, compared to €525.6 million for the comparative prior year period. R&D expenses were mainly driven by higher expenses for the development of immuno-oncology ("IO") and antibody-drug conjugate ("ADC") programs, in particular pumitamig and gotistobart, as well as costs from operations of entities acquired during 2025, BioNTech China (previously Biotheus) and CureVac, and an impairment of an intangible asset. These effects were partly offset by lower R&D expenses related to the Company’s COVID‑19 vaccine collaboration with Pfizer Inc. ("Pfizer").

Adjusted R&D expenses were €527.1 million for the first quarter of 2026, compared to €525.6 million for the comparative prior year period. For the first quarter of 2026, adjusted R&D expenses exclude the impairment of an intangible asset.

Sales, general and administrative ("SG&A") expenses5 were €150.8 million for the first quarter of 2026, compared to €120.6 million for the comparative prior year period. The increase was mainly driven by the ongoing commercial build-up and the inclusion of operations of entities acquired in 2025, BioNTech China (previously Biotheus) and CureVac. These costs were partly offset by a reduction in external services.

Net loss was €531.9 million for the first quarter of 2026, compared to a net loss of €415.8 million for the comparative prior year period.

Adjusted net loss was €494.6 million for the first quarter of 2026, compared to an adjusted net loss of €430.8 million for the comparative prior year period.

Diluted loss per share was €2.10 for the first quarter of 2026, compared to a diluted loss per share of €1.73 for the comparative prior year period.

Adjusted diluted loss per share was €1.95 for the first quarter of 2026, compared to adjusted diluted loss per share of €1.79 for the comparative prior year period.

Cash, cash equivalents and security investments as of March 31, 2026, were €16,763.3 million, comprising €9,939.4 million in cash and cash equivalents, €4,696.9 million in current security investments disclosed as financial assets and €2,127.0 million in non-current security investments disclosed as financial assets.

Shares outstanding as of March 31, 2026, were 252,884,261, excluding 6,143,226 shares held in treasury

"Our revenues for the first quarter reflect the seasonal demand for COVID-19 vaccines and are in line with our expectations," said Ramón Zapata, Chief Financial Officer at BioNTech. "We are committed to a diligent capital allocation strategy that empowers us to pursue our goal of evolving into a leading biopharmaceutical company with multiple oncology products by 2030."

Reaffirmed 2026 Financial Year Guidance6:

Revenues for the 2026 financial year €2,000 – €2,300 m

In 2026, BioNTech anticipates lower COVID-19 vaccine revenues compared to 2025, driven by declines in both the European and United States markets. The United States continues to be a competitive and dynamic market, where, as a result, lower revenues are expected. In Europe, the Company expects lower revenues as it defends its market share and begins managing the transition away from multi-year contracts. In Germany specifically, BioNTech recognizes direct sales of its COVID-19 vaccines as revenue. Hence, the anticipated declines in sales of COVID-19 vaccines in Germany will have a direct impact on the Company’s topline, whereas revenues outside of Germany only affect the Company’s topline as part of the 50% gross profit split with its partner Pfizer. Per the outlined partnership terms, revenues from the collaboration with Bristol Myers Squibb Company ("BMS") in 2026 are expected to be broadly in line with 2025. Revenues from the pandemic preparedness contract with the German government and service businesses are expected to remain stable.

Planned 2026 Financial Year Adjusted Expenses6:

Adjusted R&D expenses €2,200 – €2,500 m
Adjusted SG&A expenses5 €700 – €800 m

BioNTech will continue to focus investments on R&D and scaling the business for late-stage development and commercial readiness in oncology, while remaining cost-disciplined. Strategic capital allocation will continue to foster innovation and be a key driver of the Company’s trajectory. As part of BioNTech’s strategy, the Company may continue to evaluate appropriate corporate development opportunities with the aim of driving sustainable long-term growth and creating future value.

Planned Capital Return to Shareholders
The Management Board and Supervisory Board expect to authorize a share repurchase program of BioNTech’s American Depositary Shares ("ADSs"), pursuant to which the Company may repurchase ADSs in the amount of up to $1.0 billion over the next twelve months. BioNTech expects to use the repurchased ADSs to satisfy obligations in the ordinary course of business. The program is designed to enhance capital efficiency and support long-term value creation to execute BioNTech’s objective to become a multi-product company by 2030.

Manufacturing Footprint Consolidation
BioNTech continues to allocate capital strategically while optimizing capacities broadly to drive operational efficiency and sustainable value creation. To this end, BioNTech plans to align and consolidate its manufacturing network further where excess capacity is expected, due to evolving supply needs, mergers and acquisitions, BioNTech’s partners’ manufacturing capacities and completion of contracts.

BioNTech plans to exit operations at the manufacturing sites in Idar-Oberstein, Marburg, and Singapore as well as CureVac’s sites, affecting up to approximately 1,860 positions in total. The exit from the sites in Idar-Oberstein, Marburg, and Tübingen is planned by the end of 2027, while operations in Singapore are expected to conclude in Q1 2027. For each of these manufacturing sites, BioNTech is exploring divestment options, including a partial or total sale.

BioNTech expects cost savings to ramp up over time, potentially reaching approximately €500 million in recurring annual savings upon full implementation of the measures in 2029.7 These savings are intended to support the Company’s capital allocation to further advance its growing oncology pipeline toward commercialization.

BioNTech continues to ensure a robust drug supply via its established manufacturing network. No impact on commercial or clinical supply nor contractual obligations is expected as the affected sites will become underutilized or idle in the next 24 months.

The full interim unaudited condensed consolidated financial statements can be found in BioNTech’s Report on Form 6-K for the period ended March 31, 2026, filed today with the United States Securities and Exchange Commission ("SEC") and available at www.sec.gov.

(Press release, BioNTech, MAY 5, 2026, View Source [SID1234665106])