On May 7, 2026 Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, reported first quarter 2026 financial results and provides a corporate update.

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!

Corporate Update

INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the SOC treatment in patients with early-stage, operable triple negative breast cancer and SOC alone.
In March 2026, the Company reported the following:
•Preliminary observations of the INVINCIBLE-4 Study showed that five (5) out of seven (7) patients (71.4%) who received INT230-6 prior to SOC ("Cohort A") achieved a pathological complete response ("pCR") whereas two (2) out of six (6) (33%) patients in the SOC arm alone ("Cohort B") achieved a pCR, with one patient still to be evaluated.
•Forty-four percent (44%) fewer grade 3 or higher adverse events were observed in Cohort A compared to Cohort B.
•A protocol amendment was submitted to Swissmedic, Switzerland’s regulatory authority, and the Switzerland Ethics Committee to resume enrollment. Full approval to resume enrollment was granted on March 26, 2026. The Company plans to resume enrollment in the second quarter of 2026.
The Company expects presentation of more detailed results for the seven (7) Cohort A patients at a future oncology conference.

INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second- and third-line treatment for specific soft tissue sarcoma subtypes.
In March 2025, the Company paused new site activations and patient enrollments due to funding constraints. Before this pause, the trial had enrolled 21 patients. The Company has continued to treat patients enrolled in this study, maintain the database, conduct pharmacovigilance, and conduct other study-related activities in cooperation with its third-party contract research organizations at significantly reduced ongoing costs during this pause. In April 2026, the Company decided to resume enrollment in the INVINCIBLE-3 Study in a limited number of U.S. sites by the third quarter of 2026, and has prioritized commencing full patient enrollment and site activations in this study once sufficient incremental funding is obtained.

Lewis H. Bender, Founder, President, and CEO, stated, "The Company made excellent progress in the first quarter. We announced early data from the INVINCIBLE-4 Study, our randomized controlled study in TNBC, showing the possibilities for INT230-6 to increase efficacy while also potentially improving safety. We are now seeking additional patients in our INVINCIBLE-4 Study in Switzerland and expect to initiate enrollment in France in the second or third quarter of 2026. Further, after a successful funding campaign in 2025 and the establishment of a $60 million ATM facility in March 2026, we have made the decision to reinitiate enrollment of our INVINCIBLE-3 Study and plan to manage our cash burn judiciously. Both of our clinical trials focus on indications with high unmet medical need."

First Quarter 2026 Financial Results

Research and development expenses were $1.2 million for the three months ended March 31, 2026, compared to $2.2 million for the same period in 2025. The decrease was primarily due to lower INVINCIBLE-3 Study costs. In March 2025, the Company paused new site activations and patient enrollments in the INVINCIBLE-3 Study due to funding constraints. Prior to this pause, the trial had enrolled 21 patients. The Company has continued to treat all patients enrolled in this study in cooperation with our third-party contract research organizations during this pause. The Company plans to resume enrollment in the INVINCIBLE-3 Study in a limited number of U.S. sites by the third quarter of 2026, and has prioritized commencing full patient enrollment and site activations once sufficient funding is obtained. In addition, lower headcount-related costs in 2026 were entirely offset by an estimated bonus accrual during the three months ended March 31, 2026 compared to no bonus accrual during the three months ended March 31, 2025.

General and administrative expenses were $1.3 million for the three months ended March 31, 2026, compared to $1.2 million for the same period in 2025. The increase was due to an estimated bonus accrual during the three months ended March 31, 2026 compared to no bonus accrual during the three months ended March 31, 2025. This increase was partially offset by lower stock-based compensation and one-time expenses related to our reverse stock split in February 2026.

Overall, net loss was $2.4 million for the three months ended March 31, 2026, compared to a net loss of $3.3 million for the three months ended March 31, 2025.

As of March 31, 2026, cash and cash equivalents totaled $10.2 million.

About Triple Negative Breast Cancer in the Presurgical Setting
Women with aggressive forms of breast cancer, such as Triple Negative Breast Cancer ("TNBC"), are often counseled to undergo pre-surgical (neoadjuvant) systemic therapy in advance to reduce the risk of the disease returning. Having a pathological complete response, meaning the absence of live cancer at the time of surgery, has been shown to result in a lower risk of disease recurrence from 50% to 16% at 5 years. Approximately 11 to 17% of breast cancers test negative for estrogen receptors ("ER"), progesterone receptors (PR), and overexpression of human epidermal growth factor receptor 2 ("HER2") protein, qualifying them as triple negative. There are approximately 56,000 new cases of TNBC in the US and 420,000 worldwide diagnosed each year, 85% of which are local to the breast. TNBC is considered to be more aggressive and has a poorer prognosis than other types of breast cancer, because there are fewer available targeted medicines. Most patients with local TNBC typically receive immunochemotherapy before surgery. Since the publication of Keynote-522, the standard neoadjuvant treatment for TNBC includes systemic chemotherapy (anthracyclines, cyclophosphamide, paclitaxel, carboplatin) and the anti-PD-1 monoclonal antibody pembrolizumab. pCR rates range from 50 to 65%, depending on tumor size. Rates are generally lower in the larger-sized tumors or with lymph node metastasis. The toxicity of the Keynote-522 regimen is high, with 77% of patients experiencing grade 3 or higher treatment-related AEs, including treatment-related adverse events that lead to death in 0.5% of patients.

About Sarcoma

Soft tissue sarcoma is a rare type of cancer that starts with the growth of cells in the body’s soft tissue, such as muscle, fat, blood vessels, nerves, tendons, and linings of the joints. The disease mostly occurs in the arms, legs and belly. There are 197,000 patients in the US living with sarcoma and more than 100 types of soft tissue sarcoma, the treatment of which first involves surgery. Other treatments might include radiation therapy and then chemotherapy. Using the U.S. SEER database, the Company estimated that 14,400 patients have regional or distal (metastatic) leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma.

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

(Press release, Intensity Therapeutics, MAY 7, 2026, View Source [SID1234665330])

On May 7, 2026 Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, reported financial results for the first quarter ended March 31, 2026, and provided a business update.

"In the first quarter of 2026, momentum across Insmed’s commercial portfolio and pipeline continued to build," said Will Lewis, Chair and Chief Executive Officer of Insmed. "The trajectory of the BRINSUPRI launch continues to exceed our expectations, and we are especially encouraged by the positive topline results from the ENCORE Phase 3b study, which could enable us to extend our reach to even more patients. We remain focused on improving bronchiectasis diagnosis, expanding the ARIKAYCE label, advancing our Phase 3 programs for TPIP, and progressing our early-stage pipeline, with the ambition of delivering meaningful innovation and improving the lives of patients with serious diseases."

Progress and Anticipated Milestones by Therapeutic Area:

Respiratory

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!

BRINSUPRI

•
BRINSUPRI global revenue grew 44% in the first quarter of 2026 compared to the fourth quarter of 2025, driven by strong growth in the U.S. market.

•
In February 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization in the United Kingdom (U.K.) for BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more flare-ups or worsening of symptoms in the past 12 months.

•
Insmed anticipates a regulatory decision for brensocatib for the treatment of NCFB in Japan in 2026.

•
Insmed continues to evaluate the potential effect of evolving U.S. policies which will then impact the timing for future potential international commercial launches.

ARIKAYCE

•
ARIKAYCE global revenue grew 6% in the first quarter of 2026 compared to the first quarter of 2025, driven by strong growth in international markets.

•
In March 2026, Insmed reported positive topline results from the Phase 3b ENCORE study of ARIKAYCE in patients with Mycobacterium avium complex (MAC) lung disease, which met its primary and all multiplicity-controlled secondary culture conversion endpoints.

•
Insmed plans to submit a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for ARIKAYCE in all patients with MAC lung disease in the second half of 2026. Similarly, Insmed plans to review the data with the Pharmaceuticals and Medical Devices Agency (PMDA) in the second half of 2026 to support potential label expansion in Japan.

TPIP

•
Insmed continues to enroll patients in the PALM-ILD trial, a Phase 3 study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD).

•
In January 2026, the Office of Orphan Products Development of the FDA granted orphan drug designation to treprostinil palmitil for the treatment of patients with pulmonary arterial hypertension (PAH).

•
In April 2026, Insmed initiated the Phase 3 PALM-PAH study of TPIP in patients with PAH.

•
Insmed expects to report data from the open-label extension (OLE) of its Phase 2b study of TPIP in PAH in the third quarter of 2026.

•
Insmed anticipates initiating a Phase 3 study of TPIP in patients with progressive pulmonary fibrosis (PPF) by the end of 2026 and a Phase 3 study in patients with idiopathic pulmonary fibrosis (IPF) in the first half of 2027.

INS1148

•
Insmed plans to advance a Phase 2 development program for INS1148, initially targeting PPF and IPF, and is exploring other diseases where inhibition of the inflammatory functions of SCF248 may be beneficial.

Immunology & Inflammation

INS1033

•
Insmed’s second dipeptidyl peptidase 1 (DPP1) inhibitor, INS1033, is currently advancing toward the clinic in rheumatoid arthritis (RA) and inflammatory bowel disease (IBD), with an initial investigational new drug (IND) filing expected in the second half of 2026.

Neuro & Other Rare

INS1201

•
Insmed continues to enroll patients in the Phase 1 ASCEND clinical study of INS1201, an intrathecally delivered gene therapy for patients with Duchenne muscular dystrophy (DMD).

INS1202

•
Insmed continues to enroll patients in the Phase 1 ARMOR study of INS1202, an intrathecally delivered gene therapy for patients with amyotrophic lateral sclerosis (ALS).

2
INS1203

•
Insmed’s third gene therapy candidate, INS1203, targeting Stargardt disease, is currently advancing toward the clinic, with an IND filing expected in 2026.

Corporate Updates

•
Insmed plans to present six abstracts from across its Respiratory Therapeutic Area (BRINSUPRI, ARIKAYCE, TPIP) at the American Thoracic Society (ATS) 2026 International Conference, taking place May 15-20, 2026.

(Press release, Insmed, MAY 7, 2026, View Source [SID1234665329])

On May 7, 2026 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ) T cell therapies and γδ T cell engagers (TCEs) for cancer and autoimmune diseases, reported financial results and business highlights for the first quarter ended March 31, 2026.

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!

"In the first quarter of 2026, we continued to advance our next-generation TCE platform and clinical programs," said William Ho, Chief Executive Officer and co-founder of IN8bio. "Our encouraging GBM data positions us to engage the FDA on potential regulatory pathways forward, and we expect to deliver meaningful preclinical, regulatory and clinical milestones across our pipeline this year. As industry interest in novel TCEs accelerates, our next-generation platform is designed to address the key challenges in TCE development. We believe IN8bio is well positioned to create meaningful value for patients and shareholders in 2026 and beyond. We look forward to sharing further updates across our programs at our upcoming R&D Day in New York City on May 21, 2026."

Key Highlights

Advancing Next-Generation Gamma-Delta T Cell Engager Platform (INB-619)

Continued to advance our internally developed INB-600 platform of novel γδ T cell engagers, designed to potently eliminate targets such as CD19, potentially reduce toxicities such as cytokine release syndrome (CRS) and widen the therapeutic window over traditional CD3-targeting engagers.
Presented encouraging preclinical data for INB-619, a CD19-targeting γδ T cell engager for oncology and autoimmune diseases. The data showed complete B cell depletion, robust γδ T cell expansion, and minimal CRS-associated cytokine release (IL-6, TNF-α), reinforcing the platform’s differentiation and therapeutic potential.
Progressing INB-619 into IND-enabling studies, with initial animal data expected in 2026.

Presented Clinical Data Demonstrating Durable Survival Improvements in Newly Diagnosed Glioblastoma

In January 2026, IN8bio reported updated data as of December 31, 2025, from its Phase 1 (INB-200) and Phase 2 (INB-400) clinical trials evaluating DeltEx drug resistant immunotherapy (DRI) γδ T cells in patients with newly diagnosed GBM. The data included a concurrent standard-of-care (SOC) control group enrolled at the same time and clinical sites as treated patients.

Median progression-free survival (mPFS) for repeat dose patients was 13.0 months versus 6.6 months for SOC patients (+97% improvement).
Median overall survival (mOS) in repeat dose patients is still climbing, currently at 17.2+ months as of December 31, 2025, surpassing the 13.2-months for the SOC control arm.
Several patients remained progression-free beyond two years, including one grade 4, IDH-mutant glioma patient who remains progression-free with no additional therapy for more than 4.5 years.
No dose-limiting toxicities (DLTs), cytokine release syndrome (CRS), neurotoxicity (ICANS), tumor inflammation-associated neurotoxicity (TIAN) or other unexpected severe adverse events were reported.
Updated mOS results to be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting (Abstract 2077, Poster 442) on June 1, from 1:30 – 4:30 p.m. CDT.

IN8bio Research & Development Day 2026

IN8bio will host its R&D Day on May 21, 2026 (9:00 – 11:30 a.m. EDT), in New York City.
The event will feature presentations on the Company’s γδ TCE platform targeting oncology and autoimmune diseases.
The Company will also provide updates on its clinical program in GBM, including a clinical perspective from renowned neuro-oncologist Dr. David Reardon, Director, Center for Neuro-Oncology at the Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School.
Register Online: View Source

Upcoming Conferences & Anticipated Milestones

International Society for Cell & Gene Therapy (ISCT) 2026 Annual Meeting (Dublin, Ireland)

Title: Unraveling Complexity: The Impact, Interactions and Outcomes of a γδ T Cell Therapy in Glioblastoma
Poster Details: 1253
Date/Time: May 7, 2026, 18:00 to 19:30 GMT (1:00 – 2:30 p.m. EDT)
Title: Lean Infrastructure for CGT Early-Stage Companies: Leveraging Integrated Digital Platforms to Achieve Sustainable Operation Efficiency and Scalable Compliance
Poster Details: 801
Date/Time: May 7, 2026, 18:00 to 19:30 GMT (1:00 – 2:30 p.m. EDT)

American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2026 Annual Meeting (Boston, MA)

Title: Challenging the Glioblastoma Status Quo: Could γδ T Cells Shift the Balance?
Abstract: 328
Date and Time: May 14, 2026, 11:00 – 11:15 a.m. EDT

Anticipated Milestones

Guidance from the FDA on potential accelerated regulatory pathways for GBM program in 2H26.
Publication of Phase 1 INB-200 clinical data in newly diagnosed GBM patients in a peer-reviewed journal.
Additional GBM clinical updates, including updated mOS data at ASCO (Free ASCO Whitepaper) 2026.
Initial TCE preclinical animal data and additional IND-enabling data for INB-619 in 2H26.
Completion of INB-100 patient dosing and presentation of long-term follow-up results at a medical meeting in late 2026.

First Quarter 2026 Financial Highlights

Cash position: As of March 31, 2026, the Company had cash of $21.9 million, compared with $11.9 million, for the comparable prior year period.
Research and Development (R&D) expenses: R&D expenses were $2.6 million for the three months ended March 31, 2026, compared with $3.0 million for the comparable prior year period. These amounts include non-cash items such as stock-based compensation (SBC) and depreciation. The decrease primarily reflects lower clinical trial activity in the INB-400 program.
General and administrative (G&A) expenses: G&A expenses were $2.7 million for the three months ended March 31, 2026, compared with $2.7 million for the comparable prior year period. These amounts include non-cash items such as stock-based compensation (SBC) and depreciation.
Net loss: The Company reported a net loss of $5.1 million, or $0.26 per basic and diluted common share, for the three months ended March 31, 2026, compared with a net loss of $5.6 million, or $2.16 per basic and diluted common share, for the comparable prior year period.

(Press release, In8bio, MAY 7, 2026, View Source [SID1234665328])

On May 7, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a biotechnology company, reported financial and operational highlights for the fiscal quarter ended March 31, 2026. The Company reported net product revenue of approximately $44.2 million during the three months ended March 31, 2026, with net product revenue growth in every quarter since ANKTIVA’s commercial launch, including a 168% increase over Q1 2025. This builds on full-year 2025 net product revenue of $113.0 million, a 700% increase over full-year 2024. Q1 2026 net product revenue also represents a 15% sequential increase over the $38.3 million earned during Q4 2025, and the revenue growth expansion of 700% full year growth year-over-year in 2025 continues.

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!

The Company ended the quarter with $380.9 million in cash, cash equivalents and marketable securities as of March 31, 2026.

"We continue to see strong demand for ANKTIVA from both new prescribers and physicians expanding use across multiple eligible patients, including in the maintenance setting," said Richard Adcock, President and CEO of ImmunityBio. "We have also made meaningful progress expanding market access beyond the U.S., with ANKTIVA now commercially available in Saudi Arabia and additional markets anticipated this year. We are entering Q2 with a strong cash position, growing revenues, and a more experienced commercial organization positioned to support continued growth."

"We’re encouraged by the steady progress of our clinical programs and regulatory submissions across NMIBC and non-small cell lung cancer (NSCLC)," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "The full enrollment of our pivotal BCG-naïve NMIBC trial, with independent confirmation that no additional patients are required, supports our planned sBLA submission in 2026. In parallel, recent NCCN guideline updates now include ANKTIVA plus BCG for patients with BCG-unresponsive papillary-only disease, reinforcing the growing clinical evidence supporting our approach across a broader spectrum of bladder cancer patients. We are also advancing our NSCLC program in a randomized trial in patients who have progressed following prior checkpoint inhibitor therapy, an area of significant unmet need, alongside continued development of our cell therapy platforms, including CD19-targeted therapies in non-Hodgkin lymphoma and Waldenström’s macroglobulinemia, and PD-L1 t-haNK in glioblastoma."

Quarterly Financial Highlights

Cash and Marketable Securities Position

As of March 31, 2026, the Company had consolidated cash, cash equivalents, and marketable securities of $380.9 million.

First-Quarter 2026 Financial Summary

Product Revenue, Net

Product revenue, net increased $27.7 million during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025, due to increased net trade sales of ANKTIVA as a result of ongoing commercial activities.

Research and Development Expense

Research and development (R&D) expense increased $19.8 million to $68.0 million during the three months ended March 31, 2026, as compared to $48.2 million during the three months ended March 31, 2025, mainly due to increased clinical trials costs, headcount-related costs, consulting fees, and external manufacturing costs.

Selling, General and Administrative Expense

Selling, general and administrative (SG&A) expense increased $13.1 million to $45.8 million during the three months ended March 31, 2026, as compared to $32.7 million during the three months ended March 31, 2025, mainly due to increased professional services expenses, headcount-related costs, commercial-related expenses, other expense, and equipment expense.

Other Expense, Net

Other expense, net increased $497.5 million to $563.0 million during the three months ended March 31, 2026, as compared to $65.5 million during the three months ended March 31, 2025, primarily due to non-cash changes in the fair value of liabilities mainly driven by the significant increase in our common stock price. These fair value changes impacted our warrant and derivative liabilities, and a related-party convertible note. We also recorded a one-time write off of a convertible note receivable. These changes were partially offset by an increase in interest and investment income and a decrease in interest expense due to lower interest rates.

Net Loss Attributable to ImmunityBio Common Stockholders (Net Loss)

Net loss attributable to ImmunityBio common stockholders was $632.8 million during the three months ended March 31, 2026, as compared to $129.6 million during the three months ended March 31, 2025. The increase in net loss was mainly driven by changes in fair value of warrant and derivative liabilities, and a related-party convertible note due to an increase in our common stock price during the quarter, and the write off of a convertible note receivable, and higher R&D and SG&A expenses described above, which were partially offset by higher product revenue.

Adjusted Net Loss Attributable to ImmunityBio Common Stockholders (Adjusted Net Loss)

Adjusted net loss attributable to ImmunityBio common stockholders increased $3.6 million to $86.2 million during the three months ended March 31, 2026, as compared to $82.7 million during the three months ended March 31, 2025. Adjusted net loss is a non-GAAP financial measure that excludes the impact of certain items, as shown in the non-GAAP reconciliation table below.

(Press release, ImmunityBio, MAY 7, 2026, View Source [SID1234665327])

On May 7, 2026 Genmab reported Financial Results for the First Quarter of 2026.

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!

Highlights

Genmab revenue increased 25% compared to the first three months of 2025, to $896 million
FDA approved an sBLA to remove the recommendation for 24-hour hospitalization for patients with third line plus relapsed/refractory DLBCL
Remained focused on disciplined investment in our late-stage portfolio, EPKINLY (epcoritamab), Rina-S, and petosemtamab, including launch readiness

"We made tangible progress in the first quarter as we continue to integrate Merus and advance our late-stage portfolio – EPKINLY, Rina-S and petosemtamab. Across the business, our focus remained on disciplined execution, progressing these programs toward key readouts and preparing for potential launches to have an impact on more patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Three Months of 2026

Revenue was $896 million for the first three months of 2026 compared to $715 million for the first three months of 2025. The increase of $181 million, or 25%, was primarily driven by higher DARZALEX and Kesimpta royalties achieved under our collaborations with Johnson & Johnson (J&J) and Novartis Pharma AG (Novartis), respectively, and higher EPKINLY net product sales.
Royalty revenue was $742 million in the first three months of 2026 compared to $589 million in the first three months of 2025, an increase of $153 million, or 26%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta.
Net sales of DARZALEX, including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.) by J&J were $3,964 million in the first three months of 2026 compared to $3,237 million in the first three months of 2025, an increase of $727 million or 22%.
Cost of product sales were $65 million for the first three months of 2026 compared to $42 million for the first three months of 2025. The increase of $23 million, or 55%, was primarily driven by the profit-sharing amounts payable to AbbVie Inc. (AbbVie) related to EPKINLY sales.
Operating expenses, excluding Acquisition and integration related charges, were $606 million for the first three months of 2026 compared to $485 million for the first three months of 2025. The increase of $121 million, or 25%, was primarily driven by the expansion of our product pipeline, including advancement of Rina-S and petosemtamab, and the continued investment in Genmab’s global commercialization capabilities to prepare for the upcoming projected launches of Rina-S and petosemtamab.
Acquisition and integration related charges, which related primarily to severance and retention in connection with the acquisition of Merus, were $45 million in the first three months of 2026.
Amortization of acquired intangible assets was $12 million for the first three months of 2026 compared to $3 million for the first three months of 2025. The increase of $9 million, was primarily driven by the amortization of the Merus technology platform acquired in December 2025.
Operating profit was $180 million in the first three months of 2026 compared to $188 million in the first three months of 2025. Operating Profit excluding Acquisition and integration related charges and Amortization of acquired intangible assets, was $237 million in the first three months of 2026 compared to $191 million in the first three months of 2025.
Outlook
Genmab is maintaining its 2026 financial guidance published February 17, 2026.

Conference Call
Genmab will hold a conference call to discuss the results for the first three months of 2026 today, Thursday, May 7, 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, MAY 7, 2026, View Source [SID1234665326])