On May 5, 2026 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer and inflammatory and autoimmune diseases, reported financial results for the first quarter ended March 31, 2026 and provided a pipeline update on its clinical-stage investigational molecules and discovery programs.

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"Arcus is entering a new era, with a clear path for casdatifan to be both first and best in the first-line setting, and a portfolio of wholly owned molecules for inflammation and immunology that provide a new strategic optionality as they move into and through development," said Terry Rosen, Ph.D., chief executive officer of Arcus. "Our highest priority is to establish casdatifan as a foundational standard of care in kidney cancer so that patients have the opportunity to benefit from casdatifan-based regimens across lines of treatment."

Arcus is focused on completing enrollment for PEAK-1 and initiating a Phase 3 study in the 1L setting, where casdatifan has the potential to become the first HIF-2a inhibitor-based, TKI-free option, by year-end 2026.
Casdatifan (HIF-2a inhibitor)

Casdatifan Development Program:

Arcus’s development strategy is designed to generate evidence to secure casdatifan as a backbone therapy in ccRCC so that every patient has the opportunity to benefit from casdatifan across each line of therapy over the course of their care. The company is aggressively executing on a holistic strategy to embed casdatifan into the treatment paradigm, including in combination with the most commonly used regimen in the 1L setting, anti-PD-1 plus anti-CTLA-4. Arcus is now enrolling a cohort in the Phase 1/1b ARC-20 study to generate the dataset that will support the initiation of the corresponding Phase 3 study at year-end 2026. Arcus’s choice of combination partners has been designed to complement this casdatifan-IO regimen, which has the opportunity to be the first and only such HIF-2a inhibitor-based TKI-sparing 1L therapy, with consecutive treatments with casdatifan-containing regimens in first-, second-, and third-line-plus settings. In this context, Arcus will also begin to evaluate casdatifan plus TKI-containing regimens in 1L and late-line settings, the latter in both HIF-2a inhibitor-experienced and HIF-2a inhibitor-naive patients.
•IO-experienced ccRCC: Enrollment in PEAK-1, the global Phase 3 study evaluating casdatifan plus cabozantinib versus cabozantinib in IO-experienced metastatic ccRCC, is accelerating, and Arcus is on track to complete enrollment by year-end 2026.
•1L ccRCC: Arcus has been focused on the evaluation of casdatifan-based TKI-free regimens, which have demonstrated a consistently low rate of primary progression across all cohorts and settings evaluated to date.

▪Most notably, casdatifan plus zimberelimab (anti-PD-1) showed a primary progression rate of 7% (2 of 30 patients), comparing quite favorably to published rates observed with anti-PD-1 monotherapy or ipilimumab (anti-CTLA-4) plus nivolumab (anti-PD-1) in the 1L setting. This ARC-20 cohort is fully enrolled.
▪A cohort evaluating casdatifan plus zimberelimab and ipilimumab in ARC-20 is currently enrolling with the purpose of supporting Arcus’s first Phase 3 study in the 1L setting.
Planned Data Readouts:
Arcus expects to have multiple data readouts for casdatifan in 2026:
•More mature overall response rate data and initial progression-free survival data for approximately 45 patients treated in the ARC-20 cohort evaluating casdatifan plus cabozantinib in the IO-experienced setting will be presented at an investor event or at a medical conference. All patients will have had at least 12 months of follow-up.
•Initial data from the ARC-20 cohorts evaluating casdatifan in early-line settings, including the cohort evaluating casdatifan plus zimberelimab in 1L ccRCC.
•Updated data from ARC-20 late-line monotherapy cohorts including overall survival (OS) data.
Quemliclustat (small-molecule CD73 inhibitor)
•Enrollment was completed for PRISM-1, a Phase 3 trial of quemliclustat combined with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in 1L metastatic pancreatic ductal adenocarcinoma, in September 2025. Results from this study are expected in the first half of 2027.
Domvanalimab (Fc-silent anti-TIGIT antibody) plus Zimberelimab (anti-PD-1 antibody)

Status Update:
•In April 2026, Arcus announced the discontinuation of the Phase 3 STAR-121 study evaluating domvanalimab plus zimberelimab and chemotherapy versus pembrolizumab plus chemotherapy as a 1L treatment for metastatic non-small cell lung cancer (NSCLC), based on the recommendation from the Independent Data Monitoring Committee following its review of data from a pre-planned futility analysis. At the futility analysis, the domvanalimab-based combination did not improve OS relative to that observed with pembrolizumab plus chemotherapy. STAR-121, along with the Phase 2 EDGE-Lung study, will be discontinued.
◦STAR-121 also evaluated zimberelimab plus chemotherapy as an exploratory endpoint. Zimberelimab plus chemotherapy performed consistently with respect to OS as compared to pembrolizumab plus chemotherapy.
Emerging I&I Portfolio
•AB102, a highly selective, oral MRGPRX2 antagonist and potential best-in-class treatment for atopic dermatitis and chronic spontaneous urticaria, is expected to enter the clinic in the third quarter of 2026.
◦In May, Arcus will present the preclinical profile for AB102 in an oral presentation at the Society for Investigative Dermatology Annual Meeting, highlighting its ability to fully block MRGPRX2-dependent degranulation and transcriptional activation in LAD2 and primary skin mast cells and its inhibition of all common human MRGPRX2 variants.
◦Clinical development will begin with a first-in-human healthy volunteer study followed by a proof-of-concept study, with potential for proof-of-concept data in early 2027.
•Arcus has selected a development candidate for an oral small-molecule TNF inhibitor, a potential treatment for rheumatoid arthritis, psoriasis and inflammatory bowel disease, and expects it to enter the clinic in early 2027.
◦The molecule is designed to selectively block TNFR1 signaling. It is believed that this could lead to better safety and efficacy than those of approved anti-TNF antibodies that block both TNFR1 and

TNFR2 signaling, the latter of which can paradoxically lead to an inflammatory response in some patients.
•Arcus has also selected an orally active small-molecule antagonist of CCR6 as a development candidate for potential treatment of psoriasis and expects it to enter the clinic in the first half of 2027.
Financial Results for First Quarter 2026:
•Cash, Cash Equivalents and Marketable Securities were $876 million as of March 31, 2026, compared to $1.0 billion as of December 31, 2025. The decrease during the period is primarily due to the use of cash in our research and development activities. Based on our existing business plan, we believe that our cash, cash equivalents and marketable securities will be sufficient to fund our planned level of operations until at least the second half of 2028. We also expect to end 2026 with approximately $600 million in cash.
•Revenues were $17 million for the first quarter 2026, compared to $28 million for the same period in 2025. The decrease in revenue was primarily driven by lower development services revenue from the Gilead collaboration. Revenues reflect the recognition of payments previously received from our collaboration partners as we satisfy underlying performance obligations over time, and fluctuate each period based on our estimated progress toward completing those obligations rather than on the timing of cash receipts. Arcus expects to recognize GAAP revenue of between $50 million and $65 million for the full year 2026.

•Research and Development (R&D) Expenses were flat for the first quarter 2026, with (i) late-stage development programs increasing due to our investment in casdatifan and our Phase 3 PRISM-1 study for quemliclustat, partially offset by the wind-down of studies related to domvanalimab, (ii) early-stage development activities decreasing primarily due to the absence of prior-year Phase 2 study costs for domvanalimab, and (iii) partnership reimbursements decreasing, primarily due to Gilead-led activities representing a larger share of total joint development costs and a shift towards programs fully funded by us. Non-cash stock-based compensation expense was $9 million for the first quarter 2026, compared to $8 million for the same period in 2025. For the first quarters 2026 and 2025, Arcus recognized gross reimbursements of $19 million and $38 million, respectively, for shared expenses from its collaborations. R&D expenses by quarter may fluctuate due to the timing of clinical manufacturing and standard-of-care therapeutic purchases with a corresponding impact on reimbursements.
We expect R&D expenses to decline in the near term relative to what we have incurred as we wind down studies for domvanalimab. Streamlining initiatives we have undertaken across our R&D operations in connection with this wind-down, together with efficiencies we are pursuing across our programs outside the Gilead collaboration, are expected to further reduce costs. These decreases will be partially offset by our increased investment in the development of casdatifan and advancement of our small-molecule inflammation and immunology programs.
•General and Administrative (G&A) Expenses were $29 million for the first quarter 2026, compared to $28 million for the same period in 2025. The increase was primarily due to an increase in non-cash stock-based compensation, which was primarily attributable to a separation agreement with an officer. Non-cash stock-based compensation expense was $10 million for the first quarter 2026, compared to $8 million for the same period in 2025.
•Net Loss was $128 million for the first quarter 2026, compared to $112 million for the same period in 2025.

Conference Call Information:
Arcus will host a conference call and webcast today, May 5, 2026, at 1:30 PM PT/4:30 PM ET to discuss its first-quarter 2026 financial results and pipeline updates. To access the call, please dial +1 (585) 542-9983 (local) or +1 (833) 461-5787 (toll-free), using Meeting ID: 304747896. Participants may also register for the call online using the following link: View Source To access the live webcast and accompanying slide presentation, please visit the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay of the webcast will be available following the live event.

(Press release, Arcus Biosciences, MAY 5, 2026, View Source [SID1234665105])

On May 5, 2026 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib (2X-121)—a differentiated, dual PARP and WNT pathway inhibitor, reported that its active pharmaceutical ingredient (API) manufacturing campaign for stenoparib is progressing in line with the planned timeline for completion no later than the third quarter of 2026 at its world-class contract development and manufacturing organization (CDMO).

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This milestone represents a key operational advance as the Company works to secure robust drug supply while preparing for potential pivotal-stage clinical development. The decision to move forward with the campaign reflects the continuously growing confidence in stenoparib’s therapeutic potential, based on previously reported data showing extended overall survival in advanced, platinum-resistant ovarian cancer patients.

"With the Phase 3 manufacturing campaign of stenoparib approaching completion, we are taking an important step to ensuring timely advancement into potential pivotal-stage clinical trials," said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics. "This campaign reflects our confidence in the long-term potential of the program, and is particularly important as we work to leverage the FDA Fast Track designation to accelerate the development and potential approval of stenoparib."

The CDMO site, located in Europe, operates in full compliance with GMP (Good Manufacturing Practice) standards set by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Drug manufacturing for late-stage clinical development requires heightened manufacturing standards that go above and beyond the standards necessary for phase 1 and phase 2 clinical development. Triggering this campaign now ensures that the higher standard API is ready when the company is ready to advance a pivotal trial for FDA approval.

From a financial standpoint, the company has completed all payments for the manufacturing and no additional cash outlays for manufacturing are anticipated.

The manufacturing campaign is expected to be completed well in advance of the anticipated generation of critical data from Allarity’s ongoing Phase 2 trial in advanced ovarian cancer. The ongoing phase 2 trial continues to enroll patients under the new protocol, generating enthusiastic investigator engagement.

About Stenoparib/2X-121
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant WNT/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer, Small Cell Lung Cancer and colorectal cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121. Allarity has two ongoing Phase 2 trial protocols for stenoparib in Ovarian Cancer patients. In the first, patients who had had 2+ lines of therapy were enrolled on stenoparib and given drug twice daily. This protocol has been closed to further enrollment but continues for the enrolled patients who are still receiving benefit from stenoparib administration. The updated data from this study were presented at the AACR (Free AACR Whitepaper) special conference on advances in Ovarian Cancer in September 2025. Note that, as these data are from an ongoing trial, analyses may change as the study fully matures. An amended protocol designed expressly to capitalize on the emerging clinical experience with stenoparib in platinum resistant patients began enrolling patients in the summer of 2025. This amended protocol enrolls only platinum resistant or platinum-ineligible patients and is designed to accelerate the clinical development of stenoparib toward FDA approval. In parallel, a separate Phase 2 trial evaluating stenoparib in combination with temozolomide for relapsed small cell lung cancer (SCLC) began enrolling patients in early 2026 and is currently enrolling patients across multiple U.S. Veterans Administration (VA) sites.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug-specific DRP to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature.

(Press release, Allarity Therapeutics, MAY 5, 2026, View Source [SID1234665142])

On May 5, 2026 Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, reported first quarter 2026 financial results and provided a business update.

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"We recently announced positive data from our Phase 2/3 study of tovecimig and look forward to meeting with the FDA before filing a BLA later this year. Most patients with BTC have no approved therapeutic option in the second line setting. Tovecimig, with its strong response rate, striking progression benefit and impact on overall survival would be a compelling treatment alternative for these patients," said Thomas Schuetz, MD, PhD, Chief Executive Officer and Vice Chairman of the Board of Directors."

"In the post-checkpoint inhibitor setting where treatment alternatives are also critically needed, we have ongoing studies with very two promising candidates. Our novel PD-1 x PD-L1 checkpoint inhibitor CTX-8371 continues to demonstrate strong and durable clinical activity and we look forward to presenting dose-escalation and early expansion cohort data at ASCO (Free ASCO Whitepaper). CTX-10726, our differentiated PD-1 x VEGF-A bispecific antibody, is also in a Phase 1 study and we expect to share initial data later this year."

Pipeline Updates:

Tovecimig (DLL4 and VEGF-A bispecific antibody)

In April 2026, the Company announced data from its Phase 2/3 study of tovecimig, which it plans to include in a BLA submission, to treat patients with biliary tract cancer in the second line setting:

Overall Response Rate (primary endpoint): 17.1% for tovecimig combination (n=111), including one complete response, compared to 5.3% for paclitaxel alone (n=57)(p=0.031).
Progression-Free Survival (secondary endpoint): 4.7 months for tovecimig combination compared to 2.6 months for paclitaxel alone (HR=0.44, p<0.0001).
Overall Survival (secondary endpoint): Analysis was confounded by high crossover from the control arm (n=31) and markedly prolonged survival of these crossover patients after receiving tovecimig. The OS of the patients randomized to the tovecimig combination arm (n=111), which does not include the OS of these crossover patients later treated with tovecimig, was a median of 8.9 months.
PFS Before / After Crossover (secondary endpoint): Patients treated with tovecimig after crossing from the control arm progressed after a median 3.5 months (PFS2) in the third line setting. These same 31 patients, when initially randomized to paclitaxel alone (PFS1), had progressed more quickly, with a median of 1.9 months in the second line setting (HR=0.36, p=0.0016).
OS Crossover vs. Non-Crossover (post hoc subset analysis): In an analysis of OS in all patients initially randomized to the paclitaxel control arm (n=57), crossover patients who subsequently received tovecimig demonstrated a statistically significant improvement in median OS of 12.8 months compared to 6.1 months for non-crossover patients who received only paclitaxel (n=26)(HR=0.54, p=0.04).
Pooled OS of All Patients Treated with Tovecimig (post hoc subset analysis): For all patients treated with tovecimig, including both crossover patients and patients initially randomized to the tovecimig combination arm (n=142), the pooled median OS was 9.8 months. The median OS for patients randomized to the paclitaxel alone who did not crossover (n=26) was 6.1 months.
Safety: Tovecimig was generally well tolerated and the safety profile was consistent with prior studies, with no new safety signals identified.

The investigator sponsored trial (IST) of tovecimig in combination with the current first-line, standard-of-care regimen of gemcitabine, cisplatin, and durvalumab in patients with BTC (NCT05506943) is ongoing. The Company is evaluating multiple additional studies for tovecimig in other indications, including both ISTs and Company-sponsored studies.

CTX-8371 (PD-1 x PD-L1 bispecific antibody)

Cohort expansions for CTX-8371 have been initiated in patients with triple-negative breast cancer (TNBC, n=28), non-small cell lung cancer (NSCLC, n=28), and Hodgkin lymphoma (HL, n=12) in the post-checkpoint inhibitor setting. These indications were selected based on the deep and durable responses observed in these indications in the dose escalation portion of the study. Half of the patients with each tumor type will be dosed at 3.0 mg/kg and half will be dosed at 10.0 mg/kg.
Initial data from these cohort expansions, as well as available data from the Phase 1 dose-escalation portion of the study, will be presented at ASCO (Free ASCO Whitepaper) 2026. Additional data from the cohort expansions are expected in the fourth quarter of 2026.

CTX-10726 (PD-1 x VEGF-A bispecific antibody)

The Phase 1 study has been initiated with clinical data expected in the fourth quarter of 2026.
The Phase 1 multiple ascending dose-escalation study will include four doses (0.3, 1.0, 3.0, and 10.0 mg/kg) in a 3+3 dose-escalation design. The multi-center study will enroll patients with a prioritized set of solid tumor indications, including patients with locally advanced, unresectable or metastatic renal cell carcinoma, gastroesophageal cancer, hepatocellular carcinoma, and endometrial cancer, in whom standard of care therapies have failed.
CTX-10726 is a tetravalent PD-1 x VEGF-A bispecific antibody discovered and engineered by the Company. CTX-10726 exhibits more potent PD-1 blockade compared with data reported for other drugs in the class and the Company believes it has a unique understanding of aspects of its mechanism of action that will guide development.

CTX-471 (CD137 or 4-1BB agonist antibody)

Initiation of the Phase 2 trial of CTX-471 in patients with tumors expressing NCAM (CD56) is expected in the second half of 2026.

Financial Results

Net loss for the quarter ended March 31, 2026, was $18.3 million or $0.10 per common share, compared to $16.6 million or $0.12 per common share for the same period in 2025.

Research and Development (R&D) Expenses

R&D expenses were $13.4 million for the quarter ended March 31, 2026, as compared to $13.1 million for the same period in 2025, an increase of $0.3 million or 3%.

General and Administrative (G&A) Expenses

G&A expenses were $6.9 million for the quarter ended March 31, 2026, as compared to $4.9 million for the same period in 2025, an increase of $2.0 million or 41%. The increase was primarily driven by pre-commercialization expenses of $1.0 million and higher stock compensation (excluding stock compensation related to pre-commercialization) of $1.4 million.

Cash Position

As of March 31, 2026, cash and marketable securities were $195 million as compared to $209 million as of December 31, 2025, a decrease of $14 million, with an anticipated cash runway into 2028. During the first quarter of 2026, $18 million of net cash was used in operating activities, and this was partially offset by proceeds from exercise of common stock of $4 million.

(Press release, Compass Therapeutics, MAY 5, 2026, View Source [SID1234665157])

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.

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"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])

On May 5, 2026 MimiVax Inc. and Roswell Park Comprehensive Cancer Center reported the launch of a phase 2 clinical trial (NCT06202066) evaluating SurVaxM in combination with temozolomide in patients with progressing neuroendocrine tumors, also known as NETs. The study is being conducted at Roswell Park in Buffalo, New York, under the direction of principal investigator Dr. Jasmeet Kaur.

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The phase 2 study compares the safety and effect of temozolomide combined with SurVaxM to temozolomide alone in patients with metastatic NETs that are progressing.

SurVaxM is a peptide vaccine that has been shown to produce an immune system response against cancer cells that express the protein survivin and may block the growth of new tumor cells. The new clinical trial builds directly on phase 1 findings from NCT03879694, in which SurVaxM was well tolerated in NET patients and demonstrated measurable clinical benefit with elevated antibody responses.

"This phase 2 trial is the result of years of careful, collaborative science between MimiVax, Roswell Park Comprehensive Cancer Center, and the neuroendocrine tumor community," said Michael Ciesielski, PhD, CEO and Co-founder of MimiVax. "NET patients deserve more options, and we are excited to see if SurVaxM can become a new treatment for them."

Neuroendocrine tumors are a rare type of cancer that arise from hormone-producing cells throughout the body, most commonly in the gastrointestinal tract and lungs. Their incidence has increased significantly over the past two decades, with an estimated 28,000 people diagnosed in the U.S. each year. While many NETs grow slowly, metastatic NET disease carries a poor prognosis, and treatment options are limited once patients progress on first-line therapy. Immunotherapy has shown limited efficacy in NETs to date, making the identification of new immunologic targets and approaches important to patient care.

The phase 2 trial builds on Roswell Park’s previous NET research, which demonstrated that survivin, the protein targeted by SurVaxM, is expressed in approximately 52 percent of NET specimens, and that its expression correlates with more aggressive tumor biology and shorter survival. Importantly, the phase 1 study demonstrated that SurVaxM was safe and generated measurable immune responses in NET patients.

"Patients need more options to treat NETs, and the phase 1 data gave us confidence this is a safe, immunologically active approach to try in a larger patient population," said gastrointestinal oncologist Jasmeet Kaur, MD, FACP, study principal investigator and Assistant Professor at Roswell Park. "We are excited to see if the next trial confirms a meaningful clinical benefit that advances patient care."

The initiation of this phase 2 trial comes as MimiVax begins data analysis from its phase 2b SURVIVE trial of SurVaxM in newly diagnosed glioblastoma. SurVaxM is also being evaluated in pediatric brain tumors and multiple myeloma.

"The phase 2 NET study underscores the breadth of cancers in which survivin is a relevant therapeutic target," noted Robert Fenstermaker, MD, Roswell Park Chair Emeritus in Neurosurgery and a co-founder of MimiVax. "Once discarded as too difficult a target, our research into survivin is yielding results that are giving hope to patients with some of the toughest cancer diagnoses."

For more information about this study or other Roswell Park clinical trials, please call 1-800-ROSWELL (1-800-767-9355) or send an e-mail to [email protected] interested in participating in this study may contact Roswell Park Comprehensive Cancer Center at 1-800-ROSWELL (1-800-767-9355) or [email protected]. Additional information is available at clinicaltrials.gov (NCT06202066).

(Press release, MimiVax, MAY 5, 2026, View Source;utm_medium=rss&utm_campaign=mimivax-and-roswell-park-open-phase-2-trial-of-survaxm-for-patients-with-metastatic-neuroendocrine-tumors [SID1234665123])