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.

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"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])

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.

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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])

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 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 Applied Cells reported a collaboration with SHENTEK to integrate fast QC release solution with Applied Cells’ GoFast CAR-T manufacturing workflow on the MARS platforms.

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GoFast CAR-T is Applied Cells’ advanced rapid CAR-T manufacturing workflow designed to support closed-fluidic CAR-T production in less than 72 hours. Built on the MARS platforms, the workflow simplifies key steps including immunomagnetic T cell isolation, activation and transduction, wash, concentration, and media exchange in a streamlined process. GoFast workflow is designed to help cell therapy teams reduce complexity, accelerate manufacturing timelines, and support more scalable and cost-effective CAR-T production.

Through this collaboration, Applied Cells and SHENTEK will work together to launch Hubble, a qPCR platform with fast QC capabilities that supports same-day QC release testing of cell therapy products.

Hubble provides a hands-free approach by combining nucleic acid extraction and real-time PCR into a fully integrated, automated single-use cartridge solution. This system is designed to deliver results from sample-to-result in less than 3 hours, and offers walk-away operation. The platform features integrated internal controls, 21 CFR Part 11 compliance, and broad detection coverage for more than 180 species of Mycoplasma, Spiroplasma, and Acholeplasma currently, with sterility, VCN, and RCL capabilities planned for the near future.

"Fast, reliable QC is essential to making rapid CAR-T manufacturing more accessible," said Yuchen Zhou, CEO of Applied Cells. "By collaborating with SHENTEK, we are providing the cell therapy industry a more complete, even faster, and further lower-cost solution. Together, we aim to help cell therapies move closer to affordability, and scalable production."

This collaboration is part of Applied Cells’ broader mission to enable low cost, fast, simple, and scalable cell therapy manufacturing for global users. By pairing the MARS GoFast workflow with Hubble, Applied Cells and SHENTEK aim to accelerate patient access of life-saving CAR-T cell therapies around the world.

Applied Cells and SHENTEK will showcase the GoFast CAR-T workflow and Hubble Fast QC capabilities together at ASGCT (Free ASGCT Whitepaper) 2026. Attendees can visit Poster #2398 for GoFast CAR-T, Poster #1197 for Hubble Fast QC, and Booth #932 to learn more about the collaboration and early access opportunities.

(Press release, Applied Cells, MAY 5, 2026, View Source [SID1234665104])