Full Press Release Details
Genmab Announces Financial Results for the Nine Months of 2025
November 6, 2025 Copenhagen, Denmark
Interim Report for the Nine Months Ended September 30, 2025
Announcement of Genmab's proposed acquisition of Merus N.V. (Merus)
Genmab revenue increased 21% compared to the first nine months of 2024, to $2,662 million
FDA granted BTD to Rina-S in advanced endometrial cancer
Epcoritamab Phase 3 EPCORE FL-1 trial met dual primary endpoints of ORR and PFS, demonstrating statistically significant and clinically meaningful differences in both endpoints
FDA granted priority review of the sBLA for epcoritamab plus R2 in patients with relapsed or refractory FL
"In the third quarter we made advances that underscore the potential of our late-stage portfolio Epcoritamab moved closer to being available to patients in earlier lines of therapy for follicular lymphoma and Rina-S was granted Breakthrough Therapy Designation (BTD) in advanced endometrial cancer. With robust development plans for both epcoritamab and Rina-S and with Tivdak (tisotumab vedotin) now available for prescribing in Germany - our first commercial entry into a European market - we continue to execute on our strategic imperatives to accelerate our late-stage pipeline and maximize our approved medicines to reach more patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "In addition, our proposed acquisition of Merus provides us with the potential to add petosemtamab, a late-stage asset with two BTDs, to our late-stage portfolio. This proposed transaction is expected to meaningfully accelerate our shift to a wholly owned model, driving sustained growth into the next decade and contributing to our evolution into a global biotechnology leader."
Financial Performance First Nine Months of 2025
Revenue was $2,662 million for the first nine months of 2025 compared to $2,198 million for the first nine months of 2024. The increase of $464 million, or 21%, 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 $2,219 million in the first nine months of 2025 compared to $1,802 million in the first nine months of 2024, an increase of $417 million, or 23%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta.
Net sales of DARZALEX (daratumumab), 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 $10,448 million in the first nine months of 2025 compared to $8,586 million in the first nine months of 2024, an increase of $1,862 million or 22%.
Total costs and operating expenses were $1,655 million in the first nine months of 2025 compared to $1,536 million in the first nine months of 2024. The increase of $119 million, or 8%, was driven by the expansion of our product pipeline, including advancement of Rina-S, the continued development of Genmab's broader organizational capabilities as well as profit-sharing amounts payable to AbbVie Inc. (AbbVie) related to EPKINLY sales.
Operating profit was $1,007 million in the first nine months of 2025 compared to $662 million in the first nine months of 2024.
Genmab is maintaining its 2025 financial guidance published August 7, 2025.
Both the functional currency of the Genmab A S legal entity and the presentation currency of the condensed consolidated financial statements have been changed from DKK to USD effective January 1, 2025. The change in functional currency has been implemented with prospective effect. The change in presentation currency has been implemented with retrospective effect. Comparative figures for prior periods have been restated accordingly.
Genmab Announces Financial Results for the Nine Months of 2025
As disclosed in Company Announcement No. 46, Genmab and Merus announced that the companies entered into a transaction agreement pursuant to which Genmab intends to acquire all the shares of Merus, a clinical-stage biotechnology company with its late-stage breakthrough therapy asset petosemtamab, which is in Phase 3 development, for USD 97.00 per share in an all-cash transaction representing a transaction value of approximately USD 8.0 billion. The transaction is not subject to a financing condition. Consideration is expected to be funded through a combination of cash on hand and approximately $5.5 billion of non-convertible debt financing. Genmab has obtained a funding commitment from Morgan Stanley Senior Funding, Inc. for this amount. The financing package includes a meaningful portion of prepayable debt, in line with Genmab's commitment to deleveraging with a target of gross leverage 3x within two years after the closing of the proposed transaction. On October 21, 2025, a wholly owned subsidiary of Genmab commenced a tender offer for 100% of Merus' common shares. The proposed transaction is anticipated to close by early in the first quarter of 2026, subject to the satisfaction of customary closing conditions for similar transactions. In addition to the Company Announcement, further information may be found in Notes 1 and 2, below.
Genmab will hold a conference call to discuss the results for the first nine months of 2025 today, Thursday, November 6, at 6 00 pm CET, 5 00 pm GMT or 12 00 pm EST. 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 https register-conf.media-server.com register BI1532cd9886ad43bea2ecd7c91c404a7d. A live and archived webcast of the call and relevant slides will be available at www.genmab.com investor-relations.
Marisol Peron, Senior Vice President, Global Communications Corporate Affairs
T +1 609 524 0065 E mmp genmab.com
Andrew Carlsen, Vice President, Head of Investor Relations
T +45 3377 9558 E acn genmab.com
*ORR overall response rate PFS progression-free survival sBLA supplemental Biologics License Application FDA U.S. Food and Drug Administration R2 rituximab and lenalidomide FL follicular lymphoma PDUFA Prescription Drug User Fee Act BTD Breakthrough Therapy Designation
Interim Report for the Nine Months of 2025
| CONTENTS | |
| MANAGEMENT'S REVIEW | |
| CONSOLIDATED KEY FIGURES | 4 |
| OUTLOOK | 5 |
| PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST NINE MONTHS OF 2025 | 6 |
| SIGNIFICANT RISKS AND UNCERTAINTIES | 15 |
| FINANCIAL REVIEW | 16 |
| CONDENSED CONSOLIDATED FINANCIAL STATEMENTS | 24 |
| NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS | 28 |
| ABOUT GENMAB | 42 |
| DIRECTORS' AND MANAGEMENT'S STATEMENT ON THE INTERIM REPORT | 43 |
Interim Report for the Nine Months of 2025
CONSOLIDATED KEY FIGURES
| (USD million, unless otherwise indicated) | Three Months Ended September 30, | Nine Months Ended September 30, | Full Year | |||||||||||||||||||||||
| Income Statement | 2025 | 2024 | 2025 | 2024 | 2024 | |||||||||||||||||||||
| Revenue | $ | 1,022 | $ | 816 | $ | 2,662 | $ | 2,198 | $ | 3,121 | ||||||||||||||||
| Cost of product sales | (58) | (40) | (157) | (95) | (143) | |||||||||||||||||||||
| Research and Development expenses | (357) | (336) | (1,080) | (1,032) | (1,414) | |||||||||||||||||||||
| Selling, general and administrative expenses | (148) | (127) | (418) | (370) | (549) | |||||||||||||||||||||
| Acquisition and integration related charges | - | (3) | - | (39) | (43) | |||||||||||||||||||||
| Total costs and operating expenses | (563) | (506) | (1,655) | (1,536) | (2,149) | |||||||||||||||||||||
| Operating profit | 459 | 310 | 1,007 | 662 | 972 | |||||||||||||||||||||
| Net financial items | 23 | (57) | 142 | 147 | 354 | |||||||||||||||||||||
| Net profit | $ | 401 | $ | 186 | $ | 932 | $ | 581 | $ | 1,133 | ||||||||||||||||
| Balance Sheet | ||||||||||||||||||||||||||
| Marketable securities | $ | 1,650 | $ | 1,648 | $ | 1,650 | $ | 1,648 | $ | 1,574 | ||||||||||||||||
| Cash and cash equivalents | 1,761 | 952 | 1,761 | 952 | 1,380 | |||||||||||||||||||||
| Total non-current assets | 2,550 | 2,397 | 2,550 | 2,397 | 2,514 | |||||||||||||||||||||
| Total assets | 7,021 | 5,955 | 7,021 | 5,955 | 6,414 | |||||||||||||||||||||
| Shareholders' equity | 5,751 | 4,793 | 5,751 | 4,793 | 5,137 | |||||||||||||||||||||
| Share capital | $ | 10 | $ | 10 | $ | 10 | $ | 10 | $ | 10 | ||||||||||||||||
| Cash Flow Statement | ||||||||||||||||||||||||||
| Net cash provided by operating activities | $ | 536 | $ | 299 | $ | 885 | $ | 737 | $ | 1,126 | ||||||||||||||||
| Net cash provided by (used in) investing activities | (54) | 21 | (71) | (1,459) | (1,447) | |||||||||||||||||||||
| Net cash (used in) financing activities | (21) | (41) | (440) | (564) | (566) | |||||||||||||||||||||
| Investment in intangible assets | - | (2) | (18) | (2) | (17) | |||||||||||||||||||||
| Investment in tangible assets | $ | (2) | $ | (5) | $ | (24) | $ | (13) | $ | (27) | ||||||||||||||||
| Financial Ratios and Other Information | ||||||||||||||||||||||||||
| Basic net profit per share | $ | 6.51 | $ | 2.94 | $ | 14.95 | $ | 9.04 | $ | 17.66 | ||||||||||||||||
| Diluted net profit per share | $ | 6.46 | $ | 2.92 | $ | 14.90 | $ | 8.99 | $ | 17.53 | ||||||||||||||||
| Period-end share market price (DKK per share) | 1,928 | 1,620 | 1,928 | 1,620 | 1,493 | |||||||||||||||||||||
| Price book value | $ | 3.35 | $ | 3.38 | $ | 3.35 | $ | 3.38 | $ | 2.91 | ||||||||||||||||
| Shareholders' equity per share | $ | 575.10 | $ | 479.30 | $ | 575.10 | $ | 479.30 | $ | 513.70 | ||||||||||||||||
| Equity ratio | 82 | % | 80 | % | 82 | % | 80 | % | 80 | % | ||||||||||||||||
| Shares outstanding | 64,206,349 | 66,176,831 | 64,206,349 | 66,176,831 | 66,187,186 | |||||||||||||||||||||
| Average number of employees (FTE*) | 2,663 | 2,591 | 2,656 | 2,488 | 2,535 | |||||||||||||||||||||
| Number of employees (FTE) at the end of the period | 2,681 | 2,635 | 2,681 | 2,635 | 2,682 |
*Full-time equivalent or team members
Interim Report for the Nine Months of 2025
2025 FULL YEAR OUTLOOK
| (USD million) | 2025 Guidance | 2025 Guidance Mid-Point | ||
| Revenue | 3,500 - 3,700 | 3,600 | ||
| Royalties | 2,945 - 3,090 | 3,017 | ||
| Net product sales Collaboration revenue* | 425 - 465 | 445 | ||
| Milestones Reimbursement revenue | 130 - 145 | 138 | ||
| Gross profit** | 3,280 - 3,460 | 3,370 | ||
| Operating expenses** | (2,055) - (2,225) | (2,140) | ||
| Operating profit | 1,055 - 1,405 | 1,230 |
*Net Product Sales and Collaboration Revenue consists of EPKINLY Net Product Sales in the U.S. and Japan and Tivdak (Genmab's share of net profits) in the U.S. and Net Product Sales in Japan and European Markets
**Operating Expenses Range excludes Cost of Product Sales Range, which is included in Gross Profit Range
Genmab is maintaining its 2025 financial guidance published August 7, 2025.
Genmab expects its 2025 revenue to be in the range of $3.5 - 3.7 billion. Genmab's projected revenue growth for 2025 is driven by higher royalties, net product sales and collaboration revenue.
Royalty growth relates mainly to DARZALEX and Kesimpta net sales growth. DARZALEX royalties are expected to be in the range of $2.3 - $2.4 billion and are based on Genmab's estimate of DARZALEX 2025 net sales of $13.7 - 14.1 billion. DARZALEX royalties are partly offset by Genmab's share of Janssen's royalty payments to Halozyme Therapeutics, Inc. (Halozyme) in connection with SC net sales as well as royalty reduction in countries and territories where there are no Genmab patents.
Genmab is maintaining its 2025 operating expenses to be in the range of $2.1 - 2.2 billion.
Genmab expects its 2025 operating profit to be in the range of $1.1 - 1.4 billion, primarily driven by the items described above.
Outlook Risks and Assumptions
In addition to factors already mentioned, the estimates above are subject to change due to numerous reasons, including but not limited to, the achievement of certain milestones associated with Genmab's collaboration agreements the timing and variation of development activities (including activities carried out by Genmab's collaboration partners) and related income and costs DARZALEX, DARZALEX FASPRO, Kesimpta, TEPEZZA , RYBREVANT , TECVAYLI , TALVEY and TEPKINLY net sales and royalties paid to Genmab changing rates of inflation and currency exchange rates. The financial guidance assumes that no significant new agreements are entered into during the remainder of 2025 that could materially affect the results. Refer to the section "Significant Risks and Uncertainties" in this interim report for matters that may cause Genmab's actual results to differ materially from 2025 Guidance.
The factors discussed above, as well as other factors that are currently unforeseeable, may result in further and other unforeseen material adverse impacts on Genmab's business and financial performance, including on the sales of Tivdak and EPKINLY TEPKINLY, and on the net sales of DARZALEX, Kesimpta, TEPEZZA, RYBREVANT, TECVAYLI and TALVEY by Genmab's collaboration partners and on Genmab's royalties, collaboration revenue and milestone revenue therefrom.
Interim Report for the Nine Months of 2025
PRODUCT PIPELINE AND TECHNOLOGY PROGRESS NINE MONTHS OF 2025
At the end of the first nine months of 2025, Genmab's proprietary pipeline of investigational medicines, where we are responsible for at least 50% of development, consisted of nine antibody products in clinical development. These include Genmab's approved medicines, Tivdak, which Genmab is co-developing globally and co-promoting in the U.S. in collaboration with Pfizer Inc. (Pfizer) and exclusively by Genmab outside of the U.S. and China, and EPKINLY TEPKINLY, which Genmab is co-developing and co-commercializing in the U.S. and Japan in collaboration with AbbVie Inc. (AbbVie). In addition to our own pipeline, there are multiple investigational medicines in development by global pharmaceutical and biotechnology companies, including six approved medicines powered by Genmab's technology and innovations. Beyond the investigational medicines in clinical development, our pipeline includes multiple preclinical programs. An overview of the development status of our approved medicines and each of our investigational medicines is provided in the following section, including updates for the third quarter of 2025. For events that occurred during the first and second quarters of 2025, please refer to Genmab's Q1 2025 and Genmab's First Half 2025 reports. Detailed descriptions of dosing, efficacy and safety data from certain clinical trials have been disclosed in company announcements and media releases published via the Nasdaq Copenhagen A S (Nasdaq Copenhagen) stock exchange and may also be found in Genmab's filings with the U.S. Securities and Exchange Commission (U.S. SEC). Additional information is available on Genmab's website, www.genmab.com. The information accessible through our website is not part of this report and is not incorporated by reference herein.
Genmab Proprietary Products1
| Approved Product | Target | Developed By | Disease Indication 2 | |
| EPKINLY (epcoritamab-bysp, epcoritamab) TEPKINLY (epcoritamab) | CD3xCD20 | Co-development Genmab AbbVie | Approved in multiple territories including in the U.S. and Europe for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy and in Japan for adult patients with certain types of relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy | |
| Approved in multiple territories including the U.S., Europe and Japan for adult patients with relapsed or refractory FL after two or more lines of systemic therapy | ||||
| Tivdak (tisotumab vedotin-tftv, tisotumab vedotin) | Tissue factor (TF) | Co-development Genmab Pfizer | Approved in the U.S., Europe and Japan for adult patients with recurrent metastatic cervical cancer with disease progression on or after chemotherapy |
1Approved and investigational medicines where Genmab has 50% ownership, in co-development with partners as indicated.
2Refer to relevant local prescribing information for precise indication and safety information.
Interim Report for the Nine Months of 2025
Pipeline, Including Further Development for Approved Medicines
| Product | Developed By | Target(s) | Technology | Disease Indications | Most Advanced Development Phase | ||||||||
| Preclinical | 1 | 2 | 3 | ||||||||||
| Epcoritamab | Co-development Genmab AbbVie | CD3, CD20 | DuoBody | Relapsed refractory DLBCL | |||||||||
| Relapsed refractory FL | |||||||||||||
| First line DLBCL | |||||||||||||
| First line FL | |||||||||||||
| B-cell non-Hodgkin lymphoma (NHL) | |||||||||||||
| Relapsed refractory chronic lymphocytic leukemia (CLL) Richter's Syndrome | |||||||||||||
| Aggressive mature B-cell neoplasms in pediatric patients | |||||||||||||
| Tisotumab vedotin | Co-development Genmab Pfizer | TF | Antibody-drug conjugate (ADC) | Solid tumors | |||||||||
| Rinatabart Sesutecan (Rina-S, GEN1184) | Genmab | Folate receptor alpha (FR ) | ADC | Platinum resistant ovarian cancer (PROC) | |||||||||
| 2L+ endometrial cancer | |||||||||||||
| Solid tumors | |||||||||||||
| Acasunlimab (GEN1046) | Genmab | Programmed death ligand 1 (PD-L1), 4-1BB | DuoBody | Non-small cell lung cancer (NSCLC) | |||||||||
| Advanced melanoma | |||||||||||||
| Solid tumors | |||||||||||||
| GEN1042 (BNT312) | Co-development Genmab BioNTech SE (BioNTech) | CD40, 4-1BB | DuoBody | Solid tumors | |||||||||
| GEN1059 (BNT314) | Co-development Genmab BioNTech | Epithelial cell adhesion molecule (EpCAM), 4-1BB | DuoBody | Solid tumors | |||||||||
| Metastatic colorectal cancer (mCRC), in combination with pumitamig chemo | |||||||||||||
| GEN1160 | Genmab | CD70 | ADC | Advanced solid and liquid tumors | |||||||||
| GEN1057 | Genmab | Fibroblast activation protein alpha (FAP ), death receptor 4 (DR4) | DuoBody | Malignant solid tumors | |||||||||
| GEN1286 | Genmab | Epidermal growth factor receptor (EGFR), cellular-mesenchymal epithelial transition factor receptor tyrosine kinase (cMET) | ADC | Advanced solid tumors |
EPKINLY TEPKINLY (epcoritamab) - the only bispecific antibody approved with a dual indication for the treatment of certain B-cell malignancies in the U.S., Europe and Japan
Epcoritamab (approved as EPKINLY and TEPKINLY) has received regulatory approvals in multiple territories including in the U.S. and Europe for adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy, and in Japan for adult patients with certain types of relapsed or refractory LBCL after two or more lines of systemic therapy
EPKINLY TEPKINLY has also been approved in multiple territories including the U.S., Japan and Europe for the treatment of adults with relapsed or refractory FL after two or more lines of systemic therapy
More than 40 clinical trials are ongoing across different treatment settings, lines of therapy and in combination regimens across histologies, including five Phase 3 trials and additional trials in development
Two BTDs granted by the FDA for relapsed refractory FL as monotherapy after two or more therapies and in combination with R2 following at least one prior systemic therapy
SC bispecific antibody targeting CD3 and CD20, created using Genmab's DuoBody technology platform
Co-developed and co-commercialized in collaboration with AbbVie
Epcoritamab is a proprietary bispecific antibody created using Genmab's DuoBody technology platform. Epcoritamab targets CD3, which is expressed on T-cells, and CD20, a clinically validated target on malignant B-
Interim Report for the Nine Months of 2025
cells. Genmab used technology licensed from Medarex Inc. (Medarex) to generate the CD20 antibody forming part of epcoritamab. Epcoritamab is marketed as EPKINLY in the U.S., Japan, and other regions, and as TEPKINLY in Europe and other regions. See local prescribing information for specific indications and safety information. In 2020, Genmab entered into a collaboration agreement with AbbVie to jointly develop and commercialize epcoritamab. The companies share commercialization responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.
Genmab records sales in the U.S. and Japan and receives tiered royalties between 22% and 26% on remaining global sales outside of these territories, subject to certain royalty reductions. The companies have a broad clinical development program for epcoritamab including five ongoing Phase 3 trials and additional trials in planning. Please consult the U.S. Prescribing Information for EPKINLY and the European Summary of Product Characteristics for TEPKINLY for the labeled indication and safety information.
Third Quarter 2025 Updates
July The FDA accepted for priority review the sBLA for epcoritamab in combination with R2 for the treatment of adult patients with relapsed or refractory FL, following at least one prior systemic therapy. The sBLA submission was based on data from the first interim analysis of the Phase 3 EPCORE FL-1 (NCT05409066) trial. Under the PDUFA, the FDA has set a target action date of November 30, 2025. If approved, epcoritamab plus R2 would be the first bispecific antibody combination regimen available in the U.S. as a second-line treatment option for patients with relapsed refractory FL.
August In a second pre-planned interim analysis the Phase 3 EPCORE FL-1 trial met its dual primary endpoints of ORR and PFS. The safety profile of epcoritamab in combination with R2 was consistent with the known safety profiles of the individual regimens and as presented in the U.S. prescribing information for epcoritamab. These results will serve as the basis for global regulatory submissions.
September Updated results from the outpatient Phase 2 EPCORE NHL-6 trial (NCT05451810) were presented as a poster at the 13th Society of Hematologic Oncology Annual Meeting. These results demonstrated the feasibility of treating and monitoring patients in an outpatient setting following the first dose of epcoritamab and showed that the incidence and severity of adverse events associated with epcoritamab were consistent with previous epcoritamab studies in patients with relapsed refractory DLBCL.
Tivdak (tisotumab vedotin) - First and only ADC for recurrent or metastatic cervical cancer in the U.S., Europe and Japan
An ADC directed to TF, a protein highly prevalent in solid tumors, including cervical cancer, which is associated with poor prognosis
Tisotumab vedotin, approved as Tivdak, is the first and only ADC approved in the U.S., Europe and Japan for the treatment of recurrent or metastatic cervical cancer after prior therapy and is the only ADC with demonstrated overall survival data in this setting compared to chemotherapy
Co-developed globally and co-promoted in the U.S. in collaboration with Pfizer, exclusively by Genmab outside of the U.S. and China
Tisotumab vedotin is an ADC composed of Genmab's human monoclonal antibody directed to TF and Pfizer's ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Genmab used technology licensed from Medarex to generate the TF antibody forming part of tisotumab vedotin. Tisotumab vedotin, marketed as Tivdak, is the first and only ADC approved for the treatment of adult patients with recurrent or metastatic cervical cancer after prior therapy in the U.S., Europe and Japan. Tisotumab vedotin is being co-developed by Genmab and Pfizer. Under a joint commercialization agreement, Genmab is co-promoting Tivdak in the U.S. and is leading commercial operational activities in Japan, Europe and all other regions globally, excluding the United States and China. Pfizer is leading commercial operational activities in the U.S. and will lead commercial operational activities in China once approved in connection with the sublicense of its rights to develop and commercialize tisotumab vedotin in China to Zai Lab. Genmab will record sales for Europe, Japan and rest of world markets (excluding
Interim Report for the Nine Months of 2025
the United States and China), and will provide royalties in the low teens to Pfizer on net sales. The companies have joint decision-making power on the worldwide development and commercialization strategy for Tivdak. Please consult the U.S. Prescribing Information and the European Summary of Product Characteristics for the labeled indication and safety information for Tivdak.
Third Quarter 2025 Update
September Tivdak became available for prescribing in Germany. This is the first European country where this medicine is commercially available following approval by the European Commission in March 2025.
Rinatabart Sesutecan (Rina-S, GEN1184) - Potential best-in-class FR -targeted topoisomerase I (TOPO1) ADC
FR -targeted TOPO1 ADC being evaluated for potential treatment of FR -expressing cancers
Phase 3 clinical trial (NCT06619236) in PROC is recruiting
Phase 2 clinical trials (dose expansion arms of NCT05579366) in PROC and second line plus endometrial cancer are recruiting
Additional trials announced including Phase 3 trials in second line plus endometrial cancer, second line platinum sensitive ovarian cancer (PSOC), and a planned Phase 2 trial in NSCLC
Rina-S is a novel FR -targeted TOPO1 ADC being evaluated for the potential treatment of ovarian cancer, endometrial cancer and other FR -expressing cancers. Dose expansion data suggests that Rina-S has robust single agent activity in various cancers across a broad range of FR expression levels. In January 2024, Rina-S was granted Fast Track Designation by the FDA for the treatment of FR -expressing high-grade serous or endometrioid PROC. A Phase 3 trial in second line plus platinum PROC is recruiting.
Third Quarter 2025 Update
August The FDA granted BTD to Rina-S for the treatment of adult patients with recurrent or progressive endometrial cancer who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy.
Acasunlimab (GEN1046) - Bispecific next-generation immunotherapy
Bispecific antibody targeting PD-L1 and 4-1BB, created using Genmab's DuoBody technology platform
A Phase 3 trial (NCT06635824, ABBIL1TY NSCLC-06) NSCLC is recruiting
Acasunlimab (GEN1046, DuoBody-PD-L1x4-1BB) is a proprietary bispecific antibody, created using Genmab's DuoBody technology platform. Originally developed in collaboration with BioNTech, in 2024 Genmab assumed sole responsibility for the continued development and potential commercialization of acasunlimab. The program will be subject to payment of certain milestones and a tiered single-digit royalty on net sales by Genmab to BioNTech. Acasunlimab is designed to induce an antitumor immune response by simultaneous and complementary PD-L1 blockade and conditional 4-1BB stimulation using an inert DuoBody format. A Phase 3 trial of acasunlimab in combination with pembrolizumab compared to docetaxel in checkpoint inhibitor (CPI)-experienced, PD-L1 positive metastatic NSCLC is recruiting. A Phase 2 trial (NCT06984328, ABBIL1TY MELANOMA-07) of acasunlimab alone and with pembrolizumab to treat advanced melanoma of the skin that has returned after treatment with an approved checkpoint inhibitor therapy is in planning.
GEN1042 (BNT312) - Bispecific antibody targeting CD40 and 4-1BB
Bispecific antibody targeting CD40 and 4-1BB, created using Genmab's DuoBody technology platform
Multiple clinical trials in solid tumors ongoing
Co-developed in collaboration with BioNTech
Interim Report for the Nine Months of 2025
GEN1042 (DuoBody-CD40x4-1BB, BNT312) is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab's DuoBody technology platform. It is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and future potential profits for GEN1042 on a 50 50 basis. CD40 and 4-1BB were selected as targets to enhance activation of both dendritic cells and antigen-dependent T-cells. Three clinical trials of GEN1042 in solid tumors are ongoing. Based on the current data, including a preliminary cohort analysis in frontline head and neck squamous cell carcinoma that did not meet our high bar for continued development, Genmab and BioNTech have agreed that no further development will be planned for GEN1042 in combination with pembrolizumab and chemotherapy beyond the currently ongoing clinical trials. The companies will evaluate the option for future potential combination opportunities with GEN1042.
GEN1059 (BNT314) - Bispecific antibody with potential in solid tumors
Bispecific antibody targeting EpCAM and 4-1BB, created using Genmab's DuoBody technology platform
Phase 1 clinical trials are ongoing
Co-developed in collaboration with BioNTech