On August 6, 2026 Halozyme Therapeutics, Inc. (Nasdaq: HALO) ("Halozyme" or the "Company") reported its financial and operating results for the second quarter ended June 30, 2026, and provided an update on its recent corporate activities.

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"We delivered another quarter of strong performance, with multiple proof points demonstrating the attractive features of ENHANZE as a compounding platform engine: repeatability of success, scalability, diversification and durability of revenues," said Dr. Helen Torley, President and Chief Executive Officer. "Total revenue increased 48% year-over-year to $481 million, royalty revenue increased 50% to $308 million and adjusted EBITDA grew 46% to $329 million, reflecting the strength of our differentiated royalty business. Based on these record results, we are raising our full year 2026 financial guidance."

"Importantly, we are delivering on both our near-term and long-term growth objectives. The ENHANZE value proposition is attracting new partners and additional products from our current partners. We expanded our royalty revenue opportunity by signing five new ENHANZE and Hypercon collaborations through July, including agreements with Vertex, Oruka, GSK, Incyte and an undisclosed partner who is the first to license ENHANZE for a nucleic acid therapeutic. We have also demonstrated our commitment to returning significant capital to shareholders, repurchasing $333 million of shares in 2Q 2026, at an average price of $69.30. Overall, these results illustrate our continued ability to create multiple waves of revenue opportunities that will drive long-term shareholder value," concluded Dr. Torley.

Second Quarter Corporate Highlight:
•In May 2026, the Company announced a new share repurchase program to repurchase up to $1.0 billion of its outstanding common stock by December 31, 2028, with an expectation of buying back at least $400 million of shares in 2026. During the second quarter of 2026, the Company repurchased 4.8 million shares for $332.8 million at an average price of $69.30 per share under the May 2026 and February 2024 share repurchase programs. The February 2024 share repurchase program was completed in June 2026.

Recent Partner Highlights:
•In July 2026, Halozyme and Incyte entered into a global collaboration and license agreement to evaluate additional subcutaneous formulations of INCA033989, a first-in-class mutant calreticulin ("mutCALR")-targeted monoclonal antibody, in patients with mutCALR-expressing myeloproliferative neoplasms ("MPNs"), utilizing Halozyme’s proprietary ENHANZE drug delivery technology. Under the collaboration, Incyte also has the option to nominate up to two additional targets for use with ENHANZE. Under the terms of the agreement, Incyte agreed to make an upfront payment and potential future milestone payments and royalties on net sales of products developed with ENHANZE.
•In the third quarter of 2026, the ongoing ARGX-119 adimanebart program was expanded to include a Phase 1 SC bioavailability study with ENHANZE.

Second Quarter Partner Highlights:
•In May 2026, Halozyme and an undisclosed company entered into a global collaboration and license agreement that provides the company access to ENHANZE to develop a nucleic acid therapeutic.
•In May 2026, Janssen announced pivotal results from the Phase 1b/2 OrigAMI-4 study showing that subcutaneous amivantamab and hyaluronidase-lpuj delivered durable responses in patients with advanced head and neck squamous cell carcinoma previously treated with immunotherapy and chemotherapy and submitted a supplemental Biologics License Application ("sBLA") to the U.S. Food and Drug Administration ("FDA").
•In May 2026, Viatris initiated a Phase 1 study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of a single dose of selatogrel in Chinese adults with chronic coronary syndrome.
•In May 2026, argenx announced FDA approval of a sBLA for VYVGART Hytrulo with ENHANZE for the treatment of adult patients with generalized myasthenia gravis including all serotypes – anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative.
•In May 2026, Halozyme and GSK plc ("GSK") entered into a global collaboration and license agreement for ENHANZE with multiple oncology targets, including the first potential application in antibody-drug conjugates. Under the terms of the agreement, GSK made an upfront payment and agreed to make potential future milestone payments and royalties on net sales of products developed with ENHANZE.
•In May 2026, Halozyme and Oruka Therapeutics, Inc. ("Oruka") entered into a global exclusive collaboration and license agreement for Halozyme’s Hypercon technology for use with ORKA-001, in development for psoriasis and related inflammatory diseases and one additional target. Under the terms of the agreement, Oruka made an upfront payment and agreed to make potential future milestone payments and mid-single digit royalties on net sales of products developed using the Hypercon technology.
•In May 2026, Takeda announced positive topline results from its pivotal Phase 2/3 trial of TAK-881 with ENHANZE in Primary Immunodeficiency Disease.
•In April 2026, Halozyme and Vertex Pharmaceuticals Incorporated ("Vertex") entered into a global exclusive collaboration and license agreement that provides Vertex access to Halozyme’s Hypercon technology for use in up to three targets. Under the terms of the agreement, Vertex made a $15 million upfront payment and agreed to make potential future milestone payments and royalties on net sales of products developed using the Hypercon technology.

Second Quarter 2026 Financial Highlights:
•Total revenue was $481.0 million, compared to $325.7 million in the second quarter of 2025. The 48% year-over-year increase was primarily driven by royalty revenue growth and an increase in product sales. Revenue included $307.7 million in royalties, an increase of 50% compared to $205.6 million in the second quarter of 2025, primarily driven by continued sales uptake of ENHANZE partner products that have launched since 2020, predominantly by VYVGART Hytrulo by argenx and DARZALEX SC Janssen in all geographies and contributions from other recently launched products.
•Cost of sales was $79.2 million, compared to $46.4 million in the second quarter of 2025. The increase in cost of sales was primarily due to an increase in bulk rHuPH20 sales.
•Amortization of intangibles expense was $29.5 million, compared to $17.8 million in the second quarter of 2025. The increase in amortization of intangibles expense was due to the acquisition of Elektrofi, Inc. ("Elektrofi") in November 2025.
•Research and development expense was $27.7 million, compared to $17.5 million in the second quarter of 2025. The increase was primarily due to the acquisition of Elektrofi and Surf Bio, Inc. ("Surf Bio") in the fourth quarter of 2025.
•Selling, general and administrative expense was $57.0 million, compared to $41.6 million in the second quarter of 2025. The increase was primarily due to an increase in consulting and professional service fees, including litigation costs incurred in connection with patent infringement litigation, the acquisition of Elektrofi and Surf Bio, and an increase in compensation expense.
•Operating income was $287.7 million, compared to $202.4 million in the second quarter of 2025.
•Net income was $229.9 million, compared to $165.2 million in the second quarter of 2025.
•EBITDA was $321.9 million, compared to $222.9 million in the second quarter of 2025. Adjusted EBITDA was $328.8 million, compared to $225.5 million in the second quarter of 2025.1
•GAAP diluted earnings per share was $1.90, compared to $1.33 in the second quarter of 2025. Non-GAAP diluted earnings per share was $2.28, compared to $1.54 in the second quarter of 2025.1
•Cash, cash equivalents, restricted cash and marketable securities were $231.9 million on June 30, 2026, compared to $145.4 million on December 31, 2025. The increase was primarily driven by cash generated from operations.

Financial Outlook for 2026
The Company is raising its 2026 financial guidance ranges, which were last provided on May 11, 2026.
For the full year 2026, the Company expects:
•Total revenue of $1.835 billion to $1.910 billion, representing growth of 31% to 37% over 2025 total revenue, primarily driven by increases in royalty revenue and product sales from API.
•Revenue from royalties of $1.220 billion to $1.245 billion, representing growth of 41% to 43% over 2025.
•Adjusted EBITDA of $1.225 billion to $1.280 billion, representing growth of 86% to 95% over 2025, including new Hypercon and Surf Bio investments of approximately $60 million.
•Non-GAAP diluted earnings per share of $8.65 to $9.00, representing growth of 108% to 117% over 2025. The Company’s earnings per share guidance includes new Hypercon and Surf

Bio investments of approximately $60 million and does not consider the impact of potential future share repurchases.
Table 1. 2026 Financial Guidance
Previous Guidance Range New Guidance Range
Total Revenue $1.710 to $1.810 billion $1.835 to $1.910 billion
Royalty Revenue $1.130 to $1.170 billion $1.220 to $1.245 billion
Adjusted EBITDA1
$1.125 to $1.205 billion $1.225 to $1.280 billion
Non-GAAP Diluted EPS1
$7.75 to $8.25 $8.65 to $9.00

1 EBITDA, Adjusted EBITDA and Non-GAAP Diluted EPS are Non-GAAP financial measures. See "Note Regarding Use of Non-GAAP Financial Measures" below for an explanation of these measures. Reconciliations between GAAP reported and Non-GAAP financial information for actual results are provided at the end of this earnings release.

Webcast and Conference Call
Halozyme will host its Quarterly Update Conference Call for the second quarter ended June 30, 2026 today, Thursday, August 6, 2026, at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed live with pre-registration via link: View Source The call will also be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit Halozyme.com.

(Press release, Halozyme, AUG 6, 2026, View Source [SID1234669794])

On August 6, 2026 Genmab reported financial results for the first half of 2026.

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Highlights

•Genmab announced positive Phase 3 results for epcoritamab plus lenalidomide in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), demonstrating statistically significant improvement in progression-free survival
•Genmab revenue increased 25% compared to the first six months of 2025, to $2,051 million
•Genmab 2026 financial guidance updated

"The second quarter of 2026 delivered clinical progress for our late-stage portfolio. Epcoritamab continued to demonstrate its potential as a core therapy across the spectrum of B-cell malignancies, with strong data across multiple treatment settings and patient populations. At the same time, new data further support the development of Rina-S (rinatabart sesutecan) in combination in advanced ovarian cancer. Together, these results reflect our continued commitment to delivering meaningful advances for patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Half of 2026
•Revenue was $2,051 million for the first six months of 2026 compared to $1,640 million for the first six months of 2025. The increase of $411 million, or 25%, was primarily driven by higher DARZALEX and Kesimpta royalties and higher EPKINLY net product sales.
•Royalty revenue was $1,708 million in the first six months of 2026 compared to $1,378 million in the first six months of 2025, an increase of $330 million, or 24%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta.
•Net sales of DARZALEX by J&J were $8,171 million in the first six months of 2026 compared to $6,776 million in the first six months of 2025, an increase of $1,395 million or 21%.
•Global net sales of EPKINLY/TEPKINLY were $312 million in the first six months of 2026 compared to $211 million in the first six months of 2025, an increase of $101 million or 48%.
•Cost of product sales were $149 million for the first six months of 2026 compared to $99 million for the first six months of 2025. The increase of $50 million, or 51%, was primarily driven by the profit-sharing amounts payable to AbbVie related to EPKINLY sales.
•Adjusted operating expenses, excluding Acquisition and integration related charges, were $1,270 million for the first six months of 2026 compared to $993 million for the first six months of 2025. The increase of $277 million, or 28%, was primarily driven by investment in our product pipeline, including the advancement of Rina-S and petosemtamab, and our global commercialization capabilities in preparation for their anticipated launches.
•Acquisition and integration related charges related to the integration of Merus were $77 million in the first six months of 2026.
•Amortization of acquired intangible assets was $24 million for the first six months of 2026 compared to $6 million for the first six months of 2025. The increase of $18 million, was primarily driven by the amortization of the Merus technology platform.
•Operating profit was $555 million in the first six months of 2026 compared to $548 million in the first six months of 2025. Adjusted operating profit, which excludes Acquisition and integration related charges and Amortization of acquired intangible assets, was $656 million in the first six months of 2026 compared to $554 million in the first six months of 2025.

Outlook
Genmab is updating its revenue, adjusted operating expenses and adjusted operating profit guidance for 2026. The improved guidance is driven by higher total royalty revenues from DARZALEX and net sales of EPKINLY.

2026 FULL YEAR OUTLOOK
(USD million) Revised Guidance² Revised
Mid-Point² Previous Guidance³ Previous Mid-Point³
Revenue 4,325 – 4,525 4,425 4,065 – 4,395 4,230
Royalties 3,625 – 3,750 3,687 3,440 – 3,685 3,563
Net product sales/Collaboration revenue¹ 595 – 640 618 490 – 555 522
Milestones/Reimbursement revenue 105 – 135 120 135 – 155 145
Gross profit 4,015 – 4,195 4,105 3,810 – 4,110 3,960
Adjusted operating expenses (2,810) – (2,950) (2,880) (2,710) – (2,910) (2,810)
Adjusted operating profit 1,065 – 1,385 1,225 900 – 1,400 1,150

1 Net product sales/Collaboration revenue consists of EPKINLY net product sales in the U.S. and Japan, and Tivdak ex-U.S. net product sales plus Genmab’s share of U.S. gross profits.
2 Adjusted operating expenses and operating profit exclude 2026 charges related to: 1) acquisition and integration-related charges of $90 million and 2) amortization of intangible assets acquired through acquisitions of $47 million.
3 Adjusted operating expenses and operating profit exclude 2026 charges related to: 1) acquisition and integration-related charges of $65 million and 2) amortization of intangible assets acquired through acquisitions of $45 million.

Non-IFRS Financial Measures
Our Adjusted operating expenses and Adjusted operating profit excludes acquisition and integration related charges and amortization of acquired intangible assets. These charges were recognized in prior periods and will likely reoccur in future periods. These items are excluded from operating expenses and operating profit because the Company believes they neither relate to the ordinary course of the Company’s business nor reflect the Company’s underlying business performance.

Non-IFRS information is intended to portray the results of our baseline performance, supplement or enhance management’s, analysts’ and investors’ overall understanding of our underlying financial performance and facilitate comparisons among current, past and future periods. This information is not intended to be considered in isolation or as a substitute for the related financial measures prepared in accordance with IFRS and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure.

Conference Call
Genmab will hold a conference call to discuss the results for the first six months of 2026 today, Thursday, August 6, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call please use the below registration link. Registered participants will receive an email with a link to access dial-in information as well as a unique personal PIN: View Source A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investor-relations.

(Press release, Genmab, AUG 6, 2026, View Source [SID1234669793])

On August 6, 2026 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported financial results and business highlights for the second quarter ended June 30, 2026.

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Second Quarter 2026 Financial Results
•Total revenue of $29.1 million, compared with $24.2 million in the second quarter of 2025
◦HEPZATO KIT revenue of $27.1 million, compared to $22.5 million in the second quarter of 2025
◦CHEMOSAT revenue of $2.0 million, compared to $1.7 million in the second quarter of 2025
•Gross margins of 90%, compared to 86% in the second quarter of 2025
•Net income of $2.7 million for both second quarters in 2026 and 2025
•Non-GAAP adjusted EBITDA of $7.6 million, compared to $9.8 million in the second quarter of 2025
•Cash provided by operations of $5.7 million in the quarter; compared to $7.3 million in the second quarter of 2025
•Cash and investments of $95.9 million as of June 30, 2026

Business Highlights
•Currently 31 active treatment centers
•Approximately 30% growth in HEPZATO volume in the second quarter 2026 compared to the second quarter 2025
•Independent investigators presented retrospective data at ESMO (Free ESMO Whitepaper) Breast Cancer 2026 showing a 60% hepatic partial response rate with percutaneous hepatic perfusion in heavily pretreated patients with liver-dominant metastatic breast cancer
•Independent investigators presented two investigator-initiated Trials-in-Progress abstracts at ASCO (Free ASCO Whitepaper) 2026: one evaluating sequential HEPZATO followed by tebentafusp in metastatic uveal melanoma, and one evaluating HEPZATO in combination with nivolumab/relatlimab in metastatic cutaneous melanoma with liver metastases
•Dosed the first patient in the global Phase 2 trial of HEPZATO in combination with standard of care in patients with liver-dominant HER2-negative metastatic breast cancer

"Our strong second quarter, including total revenue of $29.1 million and quarterly operating cash flow of $5.7 million, reflects continued momentum in HEPZATO procedures," said Gerard Michel, Chief Executive Officer of Delcath Systems. "As we grow our active treatment center network and drive physician adoption, we are seeing increased usage of HEPZATO in combination with systemic therapies to treat metastatic uveal melanoma. The growing clinical experience with this treatment strategy is strengthening physician confidence in HEPZATO and supporting its development as a multi-indication, liver-directed therapy platform, including colorectal and breast cancer."

2026 Full Year Financial Guidance
The Company’s financial outlook for fiscal year 2026:
•Total HEPZATO KIT and CHEMOSAT revenue to range from $104 million to $108 million, reflecting an increase in HEPZATO KIT volume of at least 28% over 2025
•Full year gross margins in the range of 86% to 89%
•Positive adjusted EBITDA
Second Quarter 2026 Results
Total revenue for the quarter ending June 30, 2026 was $29.1 million compared to $24.2 million for the same period in the prior year. Revenue in the quarter includes sales of $27.1 million of HEPZATO in the U.S. and $2.0 million of CHEMOSAT in Europe.
Research and development expenses for the quarter ending June 30, 2026, were $10.4 million compared to $6.9 million for the same period in the prior year. The increase is primarily due to increased clinical headcount and increased clinical trial activity.

Selling, general and administrative expenses for the quarter ended June 30, 2026, were $13.4 million compared to $11.4 million for the same period in the prior year. The increase is primarily due to continued commercial expansion activities.
Net income was $2.7 million for both the quarters ended June 30, 2026 and June 30, 2025.
Non-GAAP adjusted EBITDA for the quarter ended June 30, 2026 was $7.6 million compared to adjusted EBITDA of $9.8 million for the same period in the prior year. A table reconciling non-GAAP measures is included in this press release for reference.
As of June 30, 2026, the Company had $95.9 million in cash and investments, and no debt.

Conference Call Information
To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call.

Event Date: Thursday, August 6, 2026
Time: 8:30 AM Eastern Time

Participant Numbers:
Toll Free: 1-800-717-1738
International: 1-646-307-1865
Webcast: View Source;tp_key=cbc23b55c8

A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website View Source

(Press release, Delcath Systems, AUG 6, 2026, View Source [SID1234669792])

On August 6, 2026 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, reported an update on recent and anticipated business highlights and announced its financial results for the second quarter ended June 30, 2026.

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"At our recent Immunology Day event, we shared compelling initial clinical data for CLN-978 and velinotamig, two T cell engagers with potential to achieve immune reset and transform outcomes for people living with autoimmune diseases. We look forward to sharing additional clinical data throughout the remainder of 2026 as we rapidly advance these programs towards Phase 2 studies," said Nadim Ahmed, President and CEO of Cullinan Therapeutics.

"Additionally, following a positive End-of-Phase 1 meeting with the FDA in July, we will begin a potentially registrational Phase 2 study in patients with relapsed or refractory AML this quarter. CLN-049 represents a promising novel immunotherapeutic approach for a broad population of AML patients who currently have limited treatment options and poor prognosis. With our leadership position in the T cell engager space, we are quickly advancing a differentiated pipeline across immunology and oncology to late-stage development. Together with multiple upcoming catalysts, the company is very well-positioned for significant value creation."

Portfolio Highlights and 2026 Milestones

Immunology

•
CLN-978 (CD19xCD3 T cell engager): treatment-refractory moderate to severe systemic lupus erythematosus (SLE), difficult-to-treat rheumatoid arthritis (RA), and treatment-refractory moderate to severe Sjögren’s disease (SjD)
•
OUTRACE SLE
o
At the EULAR 2026 Congress in June, the Company presented promising initial single target dose data, which demonstrated the potential for immune reset in a refractory and heterogeneous SLE population. CLN-978 also improved lab markers of disease activity and demonstrated deep, dose-dependent B cell depletion in peripheral blood as well as dose-dependent recovery with a favorable safety profile.
o
In Q4 2026, the Company plans to share initial multi-dose regimen data. The Company also plans to begin Phase 2 expansion in early 2027 in patients with SLE and in patients with lupus nephritis.
•
OUTRACE RA
o
At the EULAR 2026 Congress and the Company’s Immunology Day event in June, the Company presented promising initial single target dose and multi-dose regimen data, which demonstrated the potential for immune reset in a heavily pretreated RA population with high baseline disease activity. CLN-978 improved disease activity in most patients, including two DAS28-ESR remissions in poly-refractory patients. CLN-978 also reduced autoantibody levels while preserving vaccine titers, and demonstrated deep, dose-dependent B cell depletion in peripheral blood and tissues with a favorable safety profile.
o
In Q3 2026, the Company plans to share additional multi-dose regimen data. The Company also plans to begin Phase 2 expansion in early 2027.
•
OUTRACE SjD
o
In Q4 2026, the Company plans to share initial data from the single target dose escalation portion of the study.
•
Velinotamig (BCMAxCD3 T cell engager): treatment-refractory autoimmune diseases driven by long-lived plasma cells

o
At the Company’s Immunology Day event in June, encouraging early clinical observations from the Genrix Bio Phase 1/2 study in China were shared. Two patients with SLE and nephritis treated with multi-dose velinotamig achieved complete renal response, and a favorable safety profile was observed. Additional multi-dose regimen data from the study are expected to be shared in Q4 2026.
o
Cullinan plans to initiate a global Phase 1/2 basket study in early 2027 in patients with autoimmune cytopenias, including immune thrombocytopenia (ITP) and autoimmune hemolytic anemia (AIHA).
Oncology

•
CLN-049 (FLT3xCD3 T cell engager): acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
o
Following a positive End-of-Phase 1 meeting with the U.S. FDA in July, the Company will initiate a potentially registrational Phase 2 study in patients with relapsed/refractory AML in Q3 2026. The study will begin with a dose-optimization phase with seamless progression to a single-arm expansion cohort at the recommended Phase 2 dose (RP2D).
o
The Company plans to share an update from the dose escalation portion of the Phase 1 study in patients with relapsed/refractory AML or MDS in Q4 2026.
o
In Q4 2026, the Company will initiate a Phase 1/2 study evaluating the combination of CLN-049, venetoclax, and azacitidine in patients with previously untreated AML.
•
Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
o
In April, the U.S. FDA accepted an NDA for zipalertinib for the treatment of patients with locally advanced or metastatic EGFR ex20ins NSCLC whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab. The Prescription Drug User Fee Act (PDUFA) target action date is February 27, 2027.
o
In February, Taiho completed enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC. Taiho expects to obtain top-line results by the end of 2026.
o
Cullinan is eligible to receive $30 million and up to $100 million upon 2L and 1L U.S. regulatory approvals, respectively, and a 50/50 profit share in the U.S.
Second Quarter 2026 Financial Results

•
Cash Position: Cash, cash equivalents, short- and long-term investments, and interest receivable were $356.0 million as of June 30, 2026. Cullinan expects its cash resources to provide runway into 2029 under its current operating plan.

•
R&D Expenses: Research and development expenses were $44.4 million for the second quarter of 2026, compared to $61.0 million for the same period in 2025.
•
G&A Expenses: General and administrative expenses were $12.8 million for the second quarter of 2026, compared to $14.8 million for the same period in 2025.
•
Net Loss: Net loss was $53.7 million for the second quarter of 2026, compared to $70.1 million for the same period in 2025.

(Press release, Cullinan Oncology, AUG 6, 2026, View Source [SID1234669791])

On August 6, 2026 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a clinical-stage company focused on developing new therapies in oncology and obesity, reported a corporate update and reported financial results for the 2026 second quarter ended June 30, 2026.

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"We’ve continued to build momentum as we prepare for two potentially impactful clinical development milestones in September: commencing enrollment of TEMPO-1, our Phase 3 study of CRB-701 in oropharyngeal cancer, and the data readout of CANYON-1, our Phase 1b study of CRB-913 in obesity. Both programs represent opportunities to address areas of significant unmet medical need," said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. "CRB-701 has the potential to bring a much-needed therapeutic option for the growing oropharyngeal cancer patient population, for whom approved and other investigational therapies have shown little promise. CRB-913 is a unique daily oral obesity drug candidate with a mechanism of action entirely orthogonal to the GLP-1 class and with the potential for both weight loss and long-term weight management. We look forward to a productive second half of 2026 as we work to improve patient outcomes and generate meaningful value for shareholders."

Key Corporate and Program Updates

CRB-701 is a next-generation, highly stable Nectin-4 targeting antibody drug conjugate (ADC) being developed to treat oropharyngeal squamous cell carcinoma (OPSCC), a type of head and neck squamous cell carcinoma (HNSCC), as well as cervical cancer. The U.S. Food and Drug Administration (FDA) has granted Fast Track designations to CRB-701 for the treatment of both cancer types. CRB-701 is licensed from CSPC Megalith Biopharmaceutical Co. Ltd. China.

Obtained FDA clearance to proceed with TEMPO-1 registrational study (n=250) of CRB-701 in 2L OPSCC, representing the first registrational trial specifically designed to evaluate a targeted treatment in this patient population.
Expect to commence enrollment in the TEMPO-1 study in September 2026.
Reported 2L+ monotherapy data from the Phase 1/2 study of CRB-701 in HNSCC and cervical cancers at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Link here for press release with more details.
Anticipate reporting CRB-701 + Keytruda combination data in first-line (1L) settings in OPSCC patients in Q1 2027 to support potential further registration-enabling trials in the front line.
CRB-913 is a highly peripherally restricted oral CB1 inverse agonist for the treatment of obesity.

Concluded last patient last visit in the CANYON-1 Phase 1b clinical trial of CRB-913 for the treatment of obesity. The CANYON-1 study followed 240 patients over a 12-week treatment period followed by a 4-week safety follow-up.
On track to report topline data from CANYON-1 Phase 1b study in September 2026.
Corporate Appointments

Corbus strengthened its leadership team and Board of Directors with several key appointments in the second quarter of 2026.

Leonardo Viana Nicacio, M.D. as Chief Medical Officer. Dr. Nicacio previously served as Chief Medical Officer at Protara Therapeutics and Senior Vice President, Head of Clinical Development and Global Medical Affairs at Stemline Therapeutics. He also held roles of increasing responsibility at Seagen (acquired by Pfizer), most recently as Vice President of Clinical Development, overseeing programs across a range of cancers, including bladder, breast, gynecologic, lung, colorectal, and head and neck cancers, and most notably the development of a therapeutic for metastatic cervical cancer, TIVDAK.
Nishant Saxena as Chief Business Officer. Mr. Saxena most recently served as Chief Financial Officer at Jeune Aesthetics, Inc., a wholly owned subsidiary of Krystal Biotech, Inc. Previously, he served as a Managing Director in Evercore’s healthcare group, where he advised on transactions totaling over $500 billion in aggregate value. Earlier in his career, Mr. Saxena held positions of increasing responsibility in private equity, venture capital, and investment advisory firms.
Brent Pfeiffenberger to Board of Directors. Dr. Pfeiffenberger is currently President and Chief Executive Officer of Century Therapeutics and the Chair of its Board of Directors. Previously, Dr. Pfeiffenberger served as Chief Operating Officer of Neogene Therapeutics (acquired by AstraZeneca). Prior to Neogene, he spent nearly two decades in leadership roles of increasing responsibility at Bristol Myers Squibb, most recently as Senior Vice President, Head of U.S. Oncology, where he oversaw business operations for the multi-billion-dollar franchise.
Financial Results for the Quarter Ended June 30, 2026

The Company reported a net loss of approximately $35.0 million, or a net loss per basic and diluted share of $1.81, for the three months ended June 30, 2026, compared to a net loss of approximately $17.7 million, or a net loss per basic and diluted share of $1.44, for the three months ended June 30, 2025.

Operating expenses increased by $17.0 million to approximately $36.2 million for the three months ended June 30, 2026, compared to approximately $19.2 million for the three months ended June 30, 2025. The increase was primarily attributable to an increase in clinical development expenses, which includes a $10.0 million development milestone payment pursuant to the licensing agreement for CRB-701.

The Company had $117.9 million of cash, cash equivalents, and investments on hand as of June 30, 2026, which is expected to fund operations into 2028 based on current operating plans and planned expenditures.

(Press release, Corbus Pharmaceuticals, AUG 6, 2026, View Source [SID1234669790])