On May 5, 2026 Exelixis, Inc. (Nasdaq: EXEL) reported financial results for the first quarter of 2026, provided an update on progress toward achieving key corporate objectives, and outlined its commercial, clinical and pipeline development milestones.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Exelixis made significant progress in the first quarter of 2026 as we remain focused on our goal of building next-generation oncology franchises," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. "Our first New Drug Application for zanzalintinib, for its initial potential indication in previously treated metastatic colorectal cancer, was accepted by U.S. regulatory authorities and is under active review, with a target action date of December 3, 2026. We also completed the expansion of our GI Sales team to accelerate cabozantinib’s momentum in neuroendocrine tumors and prepare for potential future indications with zanzalintinib. As the cabozantinib franchise continues to grow and we execute across seven ongoing or soon-to-start pivotal studies for zanzalintinib, we remain committed to strengthening our leadership in GU and GI oncology to improve standards of care for patients and drive long-term value for our shareholders."

Dr. Morrissey continued: "Our R&D organization is on track to deliver multiple milestones this year across our zanzalintinib pivotal development program. We expect key data readouts from STELLAR-303 and STELLAR-304, advancing enrollment in STELLAR-311, and initiation of STELLAR-316. We recently initiated STELLAR-201, a phase 2 study of zanzalintinib in recurrent meningioma, and in April our collaborator Merck initiated LITESPARK-034, the second phase 3 pivotal trial under our clinical collaboration evaluating zanzalintinib in combination with WELIREG in advanced renal cell carcinoma. Today, we also announced two additional zanzalintinib studies: STELLAR-202, a planned phase 2 trial in lung cancer, and a new expansion cohort within the ongoing STELLAR-002 phase 1b/2 study evaluating zanzalintinib in combination with docetaxel in castration-resistant prostate cancer. Finally, we expect to complete our current $750 million stock repurchase program this month and initiate an additional $750 million program authorized by our Board in May 2026."

First Quarter 2026 Financial Results

Total revenues for the quarter ended March 31, 2026 were $610.8 million, as compared to $555.4 million for the comparable period in 2025.

Total revenues for the quarter ended March 31, 2026 included net product revenues of $555.0 million, as compared to $513.3 million for the comparable period in 2025. The increase in net product revenues was primarily due to an increase in sales volume.

Collaboration revenues, composed of license revenues and collaboration services revenues, were $55.8 million for the quarter ended March 31, 2026, as compared to $42.2 million for the comparable period in 2025. The increase in collaboration revenues was primarily related to higher royalty revenues for the sales of cabozantinib outside the U.S. generated by Exelixis’ collaboration partner Ipsen Pharma SAS (Ipsen) and higher milestone-related revenues recognized in the quarter, partially offset by lower development cost reimbursements earned.
Research and development expenses for the quarter ended March 31, 2026 were $199.9 million, as compared to $212.2 million for the comparable period in 2025. The decrease in research and development expenses was primarily related to decreases in clinical trial costs and manufacturing costs to support our development candidates, partially offset by an increase in license and other collaboration costs.
Selling, general and administrative expenses for the quarter ended March 31, 2026 were $139.6 million, as compared to $137.2 million for the comparable period in 2025. The increase in selling, general and administrative expenses was primarily related to increases in marketing activities, legal and advisory fees, and personnel expenses, partially offset by a decrease in corporate giving.

Provision for income taxes for the quarter ended March 31, 2026 was $57.2 million, as compared to $46.1 million for the comparable period in 2025.

GAAP net income for the quarter ended March 31, 2026 was $210.5 million, or $0.81 per share, basic and $0.79 per share, diluted, as compared to GAAP net income of $159.6 million, or $0.57 per share, basic and $0.55 per share, diluted, for the comparable period in 2025. GAAP net income per share for the quarter ended March 31, 2026 was favorably impacted by lower weighted-average common shares outstanding for the quarter ended March 31, 2026, as compared to the comparable period in 2025, as a result of the stock repurchase programs.
Non-GAAP net income for the quarter ended March 31, 2026 was $232.8 million, or $0.90 per share, basic and $0.87 per share, diluted, as compared to non-GAAP net income of $179.6 million, or $0.64 per share, basic and $0.62 per share, diluted, for the comparable period in 2025.

Non-GAAP Financial Measures
To supplement Exelixis’ financial results presented in accordance with U.S. Generally Accepted Accounting Principles (GAAP), Exelixis presents non-GAAP net income (and the related per share measures), which excludes from GAAP net income (and the related per share measures) stock-based compensation, adjusted for the related income tax effect for all periods presented.
Exelixis believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Exelixis believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Exelixis’ results from period to period, and to identify operating trends in Exelixis’ business. Exelixis has excluded stock-based compensation, adjusted for the related income tax effect, because it is a non-cash item that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance for the periods presented. Exelixis also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions.
These non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. Exelixis encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations, to more fully understand Exelixis’ business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release.
2026 Financial Guidance
Exelixis is maintaining the previously provided financial guidance for fiscal year 2026. Net product and total revenues guidance do not currently reflect any revenues resulting from a potential U.S. regulatory approval and commercial launch of zanzalintinib for the treatment of patients with previously treated metastatic colorectal cancer (CRC). The U.S. Food and Drug Administration (FDA) is currently reviewing Exelixis’ New Drug Application (NDA) for this proposed indication, when used in combination with atezolizumab (Tecentriq).
Total revenues
$2.525 billion – $2.625 billion
Net product revenues
$2.325 billion – $2.425 billion(1)
Cost of goods sold, % of net product revenues 3.5% – 4.5%
Research and development expenses
$875 million – $925 million(2)
Selling, general and administrative expenses
$575 million – $625 million(3)
Effective tax rate 21% – 23%

Cabozantinib Highlights

Net product revenues generated by the cabozantinib franchise in the U.S. were $555.0 million during the first quarter of 2026, with net product revenues of $552.8 million from CABOMETYX (cabozantinib) and $2.2 million from COMETRIQ (cabozantinib). Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners, Ipsen and Takeda Pharmaceutical Company Limited, during the quarter ended March 31, 2026, Exelixis earned $45.9 million in royalty revenues.

Zanzalintinib Highlights

FDA Acceptance of NDA for Zanzalintinib in Combination with Atezolizumab for Previously Treated Metastatic CRC, Based on Positive Results of STELLAR-303 Phase 3 Pivotal Trial. In February 2026, Exelixis announced that the U.S. FDA accepted its NDA for zanzalintinib as a treatment for patients with metastatic CRC, when used in combination with atezolizumab. The FDA assigned a standard review with a Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026. The NDA was based on positive results from the STELLAR-303 phase 3 pivotal trial, in which zanzalintinib in combination with atezolizumab demonstrated a statistically significant improvement in overall survival (OS) versus regorafenib in the intention-to-treat (ITT) population. An OS benefit with the combination was consistently observed across pre-specified subgroups, including geographic region, RAS status, liver involvement and prior anti-VEGF therapy.

The trial is proceeding to the planned final analysis of the other dual primary endpoint, OS in patients without liver metastases (NLM), which is expected in mid-2026, depending on event rates.

Topline Results for STELLAR-304 Phase 3 Pivotal Trial Expected in Second Half of 2026. Today, Exelixis announced that the company expects topline results from the STELLAR-304 trial in the second half of 2026, depending on event rates. STELLAR-304 is a phase 3 pivotal trial evaluating zanzalintinib in combination with nivolumab versus sunitinib in previously untreated patients with advanced non-clear cell renal cell carcinoma (RCC). The primary endpoints of the trial are progression-free survival (PFS) as assessed by blinded independent radiology committee and objective response rate (ORR) per RECIST 1.1, with OS as the secondary endpoint.

Enrollment Progress for STELLAR-311 Phase 2/3 Pivotal Trial. Exelixis is continuing to actively enroll patients in the STELLAR-311 phase 2/3 pivotal trial. STELLAR-311 is evaluating zanzalintinib versus everolimus as a first oral therapy in patients with advanced neuroendocrine tumors, regardless of site of origin, who have received up to one prior line of therapy. The primary endpoint of the trial is PFS per RECIST 1.1 as assessed by blinded independent central review.
Collaboration Agreement with Natera for STELLAR-316 Phase 3 Pivotal Trial. In January 2026, Exelixis announced a collaboration with Natera, a global leader in cell-free DNA and precision medicine, for STELLAR-316, the planned, Exelixis-sponsored phase 3 pivotal trial. STELLAR-316 will evaluate zanzalintinib, with and without an immune checkpoint inhibitor, in patients with resected stage II/III CRC who, following definitive therapy, have tested positive for molecular residual disease (MRD+) and have no radiographic evidence of disease. The primary endpoint of STELLAR-316 will be disease-free survival, with secondary endpoints including circulating tumor DNA clearance. Natera will provide its Signatera assay to identify MRD+ patients for trial enrollment. Exelixis expects to initiate STELLAR-316 in mid-2026.

Initiation of LITESPARK-034 Phase 3 Pivotal Trial as Part of Clinical Development Collaboration with Merck. In April 2026, Exelixis’ collaborator Merck, known as MSD outside of the United States and Canada, initiated LITESPARK-034, a global phase 3 pivotal trial evaluating zanzalintinib in combination with WELIREG (belzutifan) versus WELIREG and placebo in second-line or later advanced RCC patients who have progressed on or after both programmed death-ligand 1 (PD-1/L1) and vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFR-TKI) therapies in sequence or in combination. LITESPARK-034 is the second of two Merck-sponsored phase 3 pivotal trials of zanzalintinib and WELIREG in RCC under the companies’ clinical development collaboration. Merck initiated the first trial, LITESPARK-033, in December 2025. LITESPARK-033 is evaluating the combination of zanzalintinib and WELIREG versus cabozantinib in first-line advanced RCC following an immunotherapy administered in the adjuvant setting.
Initiation of STELLAR-201 Phase 2 Trial in Recurrent Meningioma. Today, Exelixis announced it has initiated STELLAR-201, a phase 2 trial evaluating zanzalintinib in patients with recurrent Grade I/II/III meningioma with relapse or progression following radiation and/or surgery or those who are not candidates for these therapies. The primary endpoint of the trial is ORR, with secondary endpoints including PFS, duration of response (DOR) and OS. Pending favorable results, the trial represents an opportunity for zanzalintinib to become the first and only systemic therapy for this form of cancer where patients have few effective treatment options.

Expansion of Zanzalintinib Clinical Development Program. Today, Exelixis announced two additional studies for zanzalintinib, including STELLAR-202, a planned phase 2 trial evaluating zanzalintinib in combination with pembrolizumab in the maintenance setting in squamous non-small cell lung cancer, and an additional expansion cohort in the ongoing phase 1b/2 STELLAR-002 study evaluating zanzalintinib in combination with docetaxel in metastatic castration-resistant prostate cancer patients with measurable disease. Exelixis expects to initiate STELLAR-202 and open the expansion cohort of STELLAR-002 in the second half of 2026.

Corporate Highlights

Zanzalintinib and Cabozantinib Data Presentations at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO 2026). Zanzalintinib and cabozantinib will be the subject of numerous presentations at ASCO (Free ASCO Whitepaper) 2026, which is being held from May 29 through June 2 in Chicago. Notable presentations will include an analysis of the contribution of atezolizumab to the efficacy of the combination of zanzalintinib plus atezolizumab in patients with previously treated metastatic CRC in the phase 3 STELLAR-303 trial, as well as a subgroup analysis from the phase 3 CABINET pivotal trial regarding hormone functional status.

October 2025 Stock Repurchase Program (SRP) Update and Announcement of New $750 million SRP Authorized in May 2026. As of the end of the first quarter of 2026, Exelixis repurchased $590.6 million of the company’s stock, at an average price of $43.14 per share under the current SRP authorized in October 2025 (October 2025 SRP). Exelixis expects to complete the remainder of the October 2025 SRP in May 2026, fulfilling its commitment to purchase a total of $750 million of the company’s stock under the October 2025 SRP before December 31, 2026. Since Exelixis’ Board of Directors authorized the first SRP in March 2023, Exelixis has repurchased a total of $2.59 billion of the company’s common stock, retiring 86.8 million shares, at an average price of $29.86 per share, as of the end of the first quarter of 2026.

In May 2026, Exelixis’ Board of Directors authorized the repurchase of up to an additional $750 million of the company’s common stock by December 31, 2027 (May 2026 SRP). The newly authorized May 2026 SRP is the sixth such program undertaken by Exelixis since March 2023. Stock repurchases under these programs may be made from time to time through a variety of methods, which may include open market purchases, in block trades, Rule 10b5-1 trading plans, accelerated share repurchase transactions, exchange transactions or any combination of such methods. The timing and amount of any stock repurchases under the programs will be based on a variety of factors, including ongoing assessments of the capital needs of the business, alternative investment opportunities, the market price of our common stock and general market conditions. The programs do not obligate Exelixis to acquire any amount of its common stock, and may be modified, suspended or discontinued at any time without prior notice.

Basis of Presentation
Exelixis has adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31. For convenience, references in this press release as of and for the fiscal periods ended April 3, 2026 and April 4, 2025, are indicated as being as of and for the periods ended March 31, 2026 and March 31, 2025, respectively.

Conference Call and Webcast
Exelixis management will discuss the company’s financial results for the first quarter of 2026 and provide a general business update during a conference call beginning at 5:00 p.m. ET / 2:00 p.m. PT today, Tuesday, May 5, 2026.
To access the conference call, please register using this link. Upon registration, a dial-in number and unique PIN will be provided to join the call. To access the live webcast link, log onto www.exelixis.com and proceed to the Event Calendar page under the Investors & News heading. A webcast replay of the conference call will also be archived on www.exelixis.com for one year.

(Press release, Exelixis, MAY 5, 2026, View Source [SID1234665116])

On May 5, 2026 Electra Therapeutics, a clinical stage biotechnology company pioneering therapies against novel targets for diseases in immunology and cancer, reported dosing of the first patient in a Phase 1 study of ipsoprubart (ELA026) in patients with T cell malignancies. Ipsoprubart, a first-in-class monoclonal antibody targeting signal regulatory proteins (SIRP) on immune cells, is designed to selectively deplete pathological T cells and myeloid cells, with the potential to inhibit tumor growth and survival through both direct tumor cell elimination and tumor microenvironment modulation.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Initial evidence of anti-tumor activity in lymphoma, including T cell malignancies, was observed in a Phase 1b study of ipsoprubart in secondary hemophagocytic lymphohistiocytosis (sHLH), in patients whose disease was triggered by the underlying lymphoma. These findings supported advancement into a dedicated study in T cell malignancies, extending the clinical program for ipsoprubart beyond the ongoing pivotal study in sHLH. The Phase 1 study in T cell malignancies will evaluate safety and efficacy in patients treated with ipsoprubart monotherapy. T cell malignancies are a group of rare, aggressive lymphomas and leukemias arising from mature or immature T lymphocytes. More than 13,000 patients in the US are diagnosed annually with T cell malignancies and have limited effective treatment options that provide durable disease control.

"Our team has pioneered SIRP targeting as a therapeutic approach to selectively deplete pathological immune cells," said Kathy Dong, PharmD, MBA, President and CEO of Electra Therapeutics. "We are excited to follow the science and expand into T cell malignancies, where new treatment approaches are needed for patients and ipsoprubart has shown promising potential."

The open-label Phase 1 study will enroll adults with relapsed or ​refractory T cell malignancies. Patients may receive up to six cycles (24 weeks) of treatment with ipsoprubart. The study consists of two parts: Part 1 will enroll up to 24 patients to identify up to two dosing regimens with acceptable safety profiles; Part 2 will further evaluate these regimens in expansion cohorts. The primary endpoint is safety, including drug-related toxicities and treatment-emergent adverse events. Secondary endpoints include overall response rate, duration of response, and disease control rate. Additional details are available on clinicaltrials.gov (NCT07465835).

"The initiation of this study reflects strong interest from clinical investigators who were highly encouraged by the anti-tumor effect observed within weeks of treatment with ipsoprubart in the Phase 1b study in sHLH," said Kim‑Hien Dao, DO, PhD, Chief Medical Officer of Electra Therapeutics. "Patients with relapsed or refractory T cell malignancies have limited treatment options and poor outcomes. The promising activity observed in heavily treated patients, including responses to ipsoprubart monotherapy, supports our further evaluation in this setting."

Clinical Data for Ipsoprubart (ELA026) in Lymphomas, Including T Cell Malignancies
Anti-tumor activity of ipsoprubart in lymphoma was observed in a Phase 1b study in sHLH, including in patients whose disease was triggered by T cell malignancies. Among eight patients with lymphoma-associated sHLH, six of whom had T cell malignancies as the underlying trigger, the objective tumor response rate was 100% (8/8), with a complete response rate of 88% (7/8), including one durable complete response achieved with ipsoprubart monotherapy in a T cell lymphoma patient refractory to more than five lines of prior therapy. These findings were first reported in a presentation titled "ELA026, a Monoclonal Antibody Targeting SIRP‑expressing Myeloid Cells and T Lymphocytes, Demonstrates Broad Anti-Tumor Activity in Patients with Lymphoma" at the International Conference on Malignant Lymphoma in 2025.

(Press release, Electra Therapeutics, MAY 5, 2026, View Source [SID1234665115])

On May 5, 2026 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported financial results for the first quarter ended March 31, 2026, and provided a review of recent program and corporate developments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continue to make strong progress across the portfolio, completing enrollment in our Phase 3 trial of bitopertin in EPP and remaining on track to report topline data in the fourth quarter of 2026. We were also pleased to have our Phase 2 data for DISC-0974 in MF anemia selected for oral presentation at ASCO (Free ASCO Whitepaper), while continuing to advance multiple additional clinical trials across our pipeline," said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. "Together, these milestones reflect the strength of our execution and position us to deliver multiple important catalysts in the second half of this year."

Recent Highlights and Anticipated Milestones:

Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator)

Completed enrollment of Phase 3 APOLLO clinical trial of bitopertin in adults and adolescents with EPP, with topline data expected Q4 2026; study size was expanded to 183 patients due to patient and physician demand
Following completion of APOLLO, expect to submit a response to the CRL and receive an FDA decision by mid-2027
Type A meeting with the US FDA to review approach for resubmission scheduled for Q2 2026
DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression)

Updated data from Phase 2 RALLY-MF trial of DISC-0974 in patients with anemia of myelofibrosis (MF) to be shared in an oral presentation at ASCO (Free ASCO Whitepaper) in June covering N=61 patients with data through April 27, 2026
Topline data from the RALLY-MF study to be shared in Q4 2026, with an end of Phase 2 meeting with the FDA expected to occur by end of year
Progressing Phase 2 study in patients with inflammatory bowel disease (IBD) with initial data expected in 2027
DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction)

Progressing ongoing Phase 2 study in patients with polycythemia vera and Phase 1b study in patients with sickle cell disease with initial data expected in Q4 2026
First Quarter 2026 Financial Results:

Cash Position: Cash, cash equivalents, and marketable securities were $730.2 million as of March 31, 2026, which are expected to fund operational plans into 2029.
Research and Development Expenses: R&D expenses were $45.9 million for the three months ended March 31, 2026, as compared to $27.8 million for the three months ended March 31, 2025. The increase in R&D expenses was primarily driven by the progression of Disc’s portfolio, including bitopertin’s clinical studies and drug manufacturing, the advancement of the DISC-0974 and DISC-3405 programs, and increased headcount.
Selling, General and Administrative Expenses: SG&A expenses were $23.6 million for the three months ended March 31, 2026, as compared to $12.2 million for the three months ended March 31, 2025. The increase in SG&A expenses was primarily due to increased headcount and establishing infrastructure to support potential commercialization.
Net Loss: Net loss was $63.5 million for the three months ended March 31, 2026, as compared to $34.1 million for the three months ended March 31, 2025. The increase was primarily due to higher operating costs in the current period to support the continued advancement of our pipeline.

(Press release, Disc Medicine, MAY 5, 2026, View Source [SID1234665114])

On May 5, 2026 Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, reported that its product portfolio of FDA-approved brands delivered combined net revenues of $9.1 million during the first quarter of 2026. Cumberland ended the quarter with $71.0 million in total assets, $49.7 million in liabilities and $21.6 million of shareholders’ equity.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We entered 2026 with strong momentum following an outstanding 2025, which featured double-digit revenue growth, the addition of a new product to our portfolio, new international approvals and breakthrough clinical study results," said A.J. Kazimi, Cumberland Pharmaceuticals CEO. "We have built on that momentum through our recently announced Strategic Transaction, which represents an important next step in our Company’s evolution, enabling us to sharpen our focus on developing high-value product candidates, while unlocking significant value for our shareholders."

RECENT COMPANY DEVELOPMENTS INCLUDE:

Strategic Transaction
Cumberland recently announced a Strategic Transaction with Apotex Inc., the largest Canadian-based pharmaceutical company, to integrate the branded U.S. commercial businesses. Under the terms of the agreement, Apotex will acquire Cumberland’s portfolio of FDA-approved brands for $100 million in cash consideration, subject to Cumberland shareholders’ approval and certain other customary closing conditions.
This transaction is designed to unlock value and sharpen Cumberland’s focus on advancing its pipeline of differentiated product candidates designed to address unmet medical needs. The integration of Cumberland’s products will create more critical mass to support patient care and expand product distribution.
Following the closing of the transaction, Cumberland will retain its development programs, as well as its majority ownership in Cumberland Emerging Technologies. This positions Cumberland to operate with the profile of an innovative, development-stage biopharmaceutical organization devoted to new medicines for the future.

Development Pipeline

In addition to its portfolio of FDA-approved brands involved in the transaction with Apotex, Cumberland is developing ifetroban, a potent thromboxane antagonist, through a series of clinical programs designed to address unmet medical needs with significant market potential.
Cumberland has announced breakthrough results in a Phase II clinical study of ifetroban in patients with cardiomyopathy associated with Duchenne muscular dystrophy ("DMD"). This rare, fatal genetic neuromuscular disease results in deterioration of the skeletal, heart and lung muscles. Discussions with the FDA are underway regarding the study results and remaining requirements for approval.
During the first quarter of 2026, the FDA granted Fast Track Designation for Cumberland’s ifetroban candidate product for DMD patients.
This designation is intended to accelerate the development and review of therapies that address serious conditions with unmet medical needs. Importantly, it allows for more frequent FDA interaction, rolling data submissions and earlier guidance throughout the approval process. The program previously received both Orphan Drug and Rare Pediatric Disease designations from the FDA.
In addition, Cumberland has a Phase II clinical program evaluating its ifetroban product candidate in patients with Systemic Sclerosis ("SSc") or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs. Enrollment in the study is completed and the next milestone will be announcing its top-line study results.
Cumberland’s third development program involves the use of ifetroban in patients with Idiopathic Pulmonary Fibrosis ("IPF"), the most common form of progressive fibrosing interstitial lung disease. Enrollment in the study is well underway at medical centers across the U.S., with interim safety and interim efficacy results pending.

FINANCIAL RESULTS:

Net Revenue: For first quarter of 2026, the Company’s net revenues of $9.1 million, which represented a 5% increase compared to the first quarter of 2025 after removing the $3 million milestone payment last year associated with the approval of Vibativ in China. Cumberland’s branded portfolio revenue included $1.0 million for Kristalose, $2.9 million for Sancuso, $2.1 million for Vibativ, $1.0 million for Caldolor and $1.9 million for Talicia.
Operating Expenses: Total operating expenses for the quarter were $12.3 million.
Net Income (Loss): The net loss for the first quarter of 2026 was approximately $3.3 million.
Adjusted Earnings (Loss): Adjusted loss for the quarter was $1.9 million, or $0.13 per share.
Balance Sheet: At March 31, 2026, Cumberland had approximately $71.0 million in total assets, including $11.0 million in cash and cash equivalents. Liabilities totaled $49.7 million, including $5.2 million on the company’s credit facility. Total shareholders’ equity was $21.6 million on March 31, 2026.

EARNINGS REPORT CALL:
A conference call will be held today, May 5, 2026, at 4:30 p.m. Eastern Time to provide a company update and discuss the financial results.
The link to register is View Source
Registered participants can dial in from their phone using a dial-in and PIN number that will be provided to them. Alternatively, they can choose a "Call Me" option to have the system automatically call them at the start of the conference.

A replay of the call will be available for one year and can be accessed via Cumberland’s website or by visiting: View Source

(Press release, Cumberland Pharmaceuticals, MAY 5, 2026, View Source [SID1234665113])

On May 5, 2026 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP), a clinical-stage company focused on promising new therapies in oncology and obesity, reported that it will host an in-person and virtual KOL event at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting to discuss updated data from the Phase 1/2 clinical study of CRB-701 in 75 participants with head and neck squamous cell carcinoma (HNSCC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Data will include clinical response durability as well as HNSCC patient subgroup analysis. These data will be presented as a poster at the 2026 ASCO (Free ASCO Whitepaper) annual meeting, to be held May 29 – June 2, 2026 in Chicago, IL.

The KOL event will be held at the Marriott Marquis Chicago starting at 6:30AM CT on Monday, June 1st. The event will feature insights from leading HNSCC experts:

Ari Rosenberg, MD – University of Chicago Medicine
Glenn Hanna, MD – Dana-Farber Cancer Institute
Cesar Augusto Perez Batista, MD – Sarah Cannon Research Institute

A live question and answer session will follow the formal presentation and discussion. To register for either virtual or in-person attendance, click here.

The ongoing three-part Phase 1/2 study has evaluated the safety, pharmacokinetics and efficacy of CRB-701 in 317 participants with advanced solid tumors associated with high Nectin-4 expression. CRB-701 is a next-generation antibody-drug-conjugate (ADC) targeting Nectin-4, that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using MMAE as the payload.

Corbus recently announced broad alignment with the FDA on the registration path for CRB-701 in HNSCC.

About Ari Rosenberg, MD
Ari Rosenberg, MD, is a medical oncologist and Associate Professor of Medicine at the University of Chicago who specializes in using basic, translation and clinical research to improve the lives of his patients. As a clinical investigator, Dr. Rosenberg focuses on developing novel therapeutic strategies, including immunotherapy, for patients with head and neck cancer and thyroid cancer. He is also establishing methods to reduce treatment-related toxicity for better outcomes and quality of life. In 2025, Dr. Rosenberg was named to the prestigious list of 40 Under 40 in Cancer, an award that recognizes him as one of the nation’s most promising young oncology professionals and celebrates his contributions to improve the lives of those affected by cancer.

About Glenn Hanna, MD
Glenn Hanna, MD, completed his fellowship training in hematology and medical oncology at Dana-Farber Cancer Institute in 2016. Prior to this, he earned his medical degree from Georgetown University School of Medicine in 2010, where he graduated summa cum laude, a member of Alpha Omega Alpha Honor Society and the Kober Medalist for academic excellence. He joined the faculty of the Center for Head and Neck Oncology in 2017. Dr. Hanna is the Director of the Center for Cancer Therapeutic Innovation (CCTI), the early drug development program at DFCI. His clinical and translational research efforts focus on precision medicine approaches to treat head and neck cancers. He has special interests in salivary gland cancers and rare head and neck malignancies, and in molecular and immunologic biomarker discovery.

About Cesar Augusto Perez Batista, MD
Cesar Augusto Perez Batista, MD, is Director of the Drug Development Unit at Sarah Cannon Research Institute at Florida Cancer Specialists in Lake Nona, Florida. A recognized cancer expert, he leads early-phase trials for solid tumors with a focus on head and neck cancer and serves as Executive Chair of the Head and Neck Cancer Research Group for the Sarah Cannon Network. He has served on several ASCO (Free ASCO Whitepaper) head and neck committees and is an ASCO (Free ASCO Whitepaper) Ambassador. Dr. Perez is an Affiliate Associate Professor at the University of Central Florida and previously co-led Phase 1 and head and neck oncology research at the University of Miami, following earlier faculty work at the University of Louisville, where he twice earned the Best Faculty Teacher Award. He trained at the Cleveland Clinic and the University of Miami, where he was Chief Fellow and received the Peter A. Cassileth, MD Award. He is board certified in medical oncology, hematology, and internal medicine.

About CRB-701
CRB-701 (SYS6002) is a next-generation antibody drug conjugate (ADC) targeting Nectin-4, that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using MMAE as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer. The FDA has granted two Fast Track designations to CRB-701 in HNSCC and cervical cancer. CRB-701 is licensed from CSPC Megalith Biopharmaceutical Co. Ltd. China.

(Press release, Corbus Pharmaceuticals, MAY 5, 2026, View Source [SID1234665112])