Genmab Announces Financial Results for the First Quarter of 2024

May 2, 2024 Copenhagen, Denmark;

Interim Report for the First Quarter Ended March 31, 2024

Highlights

  • The U.S. Food and Drug Administration (U.S. FDA) granted Priority Review for the supplemental Biologics License Application (sBLA) for EPKINLY® (epcoritamab-bysp) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy, with a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2024
  • An additional Phase 3 clinical trial was initiated, evaluating epcoritamab in combination with rituximab and lenalidomide compared to chemoimmunotherapy in previously untreated follicular lymphoma
  • The U.S. FDA accepted for Priority Review the sBLA seeking to convert the accelerated approval of Tivdak® (tisotumab vedotin-tftv) to full approval, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy
  • Genmab announced the decision of its arbitration appeal under its daratumumab license agreement with Janssen Biotech, Inc. (Janssen)
  • Genmab revenue increased 46% compared to the first quarter of 2023, to DKK 4,143 million

"The acceptance for Priority Review by the U.S. FDA of the sBLAs for EPKINLY and Tivdak that we received in the first quarter are important events that support our commitment to continue to deliver innovative treatment options that have the potential to profoundly impact the lives of patients. These regulatory acceptances for priority review also reflect our dedication to working with our partners, AbbVie Inc. (AbbVie) and Pfizer Inc. (Pfizer) to expand the labels for EPKINLY and Tivdak, respectively, in order to maximize the potential of both medicines and bring them to as many patients in need of alternative therapeutic options as possible," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Quarter of 2024

  • Revenue was DKK 4,143 million for the first three months of 2024 compared to DKK 2,834 million for the first three months of 2023. The increase of DKK 1,309 million, or 46%, was primarily driven by higher DARZALEX® and Kesimpta® royalties achieved under our collaborations with Janssen and Novartis Pharma AG (Novartis), respectively, EPKINLY net product sales, and a milestone achieved under our collaboration with AbbVie.
  • Royalty revenue was DKK 3,104 million in the first three months of 2024 compared to DKK 2,408 million in the first three months of 2023, an increase of DKK 696 million, or 29%. 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 Janssen were USD 2,692 million in the first three months of 2024 compared to USD 2,264 million in the first three months of 2023, an increase of USD 428 million or 19%.
  • Total costs and operating expenses were DKK 3,342 million in the first three months of 2024 compared to DKK 2,417 million in the first three months of 2023. The increase of DKK 925 million, or 38%, was driven by the expansion of our product pipeline, EPKINLY post launch activities in the U.S. and Japan, the continued development of Genmab's broader organizational

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Genmab Announces Financial Results for the First Quarter of 2024

capabilities and related increase in team members to support these activities, as well as profit- sharing amounts payable to AbbVie related to EPKINLY sales.

  • Operating profit was DKK 801 million in the first three months of 2024 compared to DKK 417 million in the first three months of 2023.
  • Net financial items resulted in income of DKK 915 million for the first three months of 2024 compared to an expense of DKK 151 million in the first three months of 2023. The increase of DKK 1,066 million was primarily driven by movements in USD to DKK foreign exchange rates impacting Genmab's USD denominated cash and cash equivalents and marketable securities, with strengthening of the USD/DKK rate in the first three months of 2024 compared to the weakening of the USD/DKK rate in the first three months of 2023.

Subsequent Event

  • April: Genmab and ProfoundBio, Inc. (ProfoundBio) announced that the companies have entered into a definitive agreement for Genmab to acquire ProfoundBio in an all-cash transaction. The acquisition will give Genmab worldwide rights to three candidates in clinical development, including rinatabart sesutecan (Rina-S), plus ProfoundBio's novel antibody-drug conjugate (ADC) technology platforms. Genmab will acquire ProfoundBio for USD 1.8 billion in cash, payable at closing (subject to adjustment for ProfoundBio's closing net debt and transaction expenses). The proposed transaction is expected to close in the first half of 2024. The closing of the proposed transaction is subject to the satisfaction of customary closing conditions.

Outlook

Genmab is maintaining its 2024 financial guidance published on February 14, 2024.

Following the announcement of the proposed acquisition of ProfoundBio, Genmab's operating expenses before expenses incurred by it in connection with the proposed transaction are now anticipated to be at or moderately above the upper end of the previously disclosed guidance range of DKK 12.4 -13.4 billion. The anticipated increase reflects the incremental R&D investment to support the advancement of ProfoundBio's clinical programs, primarily Rina-S. Genmab's revenue guidance is unchanged and expected to be in the previously disclosed guidance range of DKK 18.7 - 20.5 billion.

We expect to update our guidance no later than in connection with our second quarter 2024 earnings.

Conference Call

Genmab will hold a conference call to discuss the results for the first quarter of 2024 today, Thursday, May 2, 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: https://register.vevent.com/register/BIcaf0da755ddb4d7f81f4dd2c0229135e. A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investors.

Contact

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

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Interim Report for the First Quarter of 2024

CONTENTS

MANAGEMENT'S REVIEW

CONSOLIDATED KEY FIGURES

4

OUTLOOK

5

KEY 2024 PRIORITIES

6

PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST QUARTER OF 2024

7

SIGNIFICANT RISKS AND UNCERTAINTIES

18

FINANCIAL REVIEW

18

FINANCIAL STATEMENTS

25

NOTES TO THE FINANCIAL STATEMENTS

29

ABOUT GENMAB

37

DIRECTORS' AND MANAGEMENT'S STATEMENT ON THE INTERIM REPORT

38

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Interim Report for the First Quarter of 2024

CONSOLIDATED KEY FIGURES

Three Months Ended

(DKK million)

March 31,

Full Year

Income Statement

2024

2023

2023

Revenue

4,143

2,834

16,474

Cost of product sales

(185)

-

(226)

Research and development expenses

(2,300)

(1,741)

(7,630)

Selling, general and administrative expenses

(857)

(676)

(3,297)

Total costs and operating expenses

(3,342)

(2,417)

(11,153)

Operating profit

801

417

5,321

Net financial items

915

(151)

316

Net profit

1,325

210

4,352

Balance Sheet

Marketable securities

14,914

12,256

13,268

Cash and cash equivalents

14,670

12,288

14,867

Total non-current assets

2,311

2,163

2,150

Total assets

36,680

30,219

35,289

Shareholders' equity

32,497

27,015

31,610

Share capital

66

66

66

Cash Flow Statement

Cash flow from operating activities

1,513

3,235

7,380

Cash flow from investing activities

(1,441)

(13)

(1,282)

Cash flow from financing activities

(595)

(611)

(606)

Investment in intangible assets

-

-

(10)

Investment in tangible assets

(28)

(104)

(366)

Financial Ratios and Other Information

Basic net profit per share Diluted net profit per share Period-end share market price Price / book value Shareholders' equity per share Equity ratio

Shares outstanding

Average number of employees (FTE*)

Number of employees (FTE) at the end of the period

20.29

3.21

66.64

20.18

3.19

66.02

2,084

2,589

2,155

4.23

6.33

4.50

492.38

409.32

478.94

89

%

89 %

90 %

66,122,964

65,985,932

66,074,535

2,266

1,795

2,011

2,286

1,846

2,204

* Full-time equivalent or team members

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OUTLOOK

2024

(DKK million)

Guidance

Revenue

18,700

- 20,500

Royalties

15,600

- 16,700

Net product sales/Collaboration revenue*

1,700

- 2,200

Milestones/Reimbursement revenue

1,400

- 1,600

Gross profit**

18,000

- 19,500

Operating expenses**

(12,400)

- (13,400)

Operating profit

4,600

- 7,100

*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.

**Operating Expenses Range excludes Cost of Product Sales Range, which is included in Gross Profit Range

Genmab is maintaining its 2024 financial guidance published February 14, 2024.

Following the announcement of the proposed acquisition of ProfoundBio, Genmab's operating expenses before expenses incurred by it in connection with the proposed transaction are now anticipated to be at or moderately above the upper end of the previously disclosed guidance range of DKK 12.4 -13.4 billion. The anticipated increase reflects the incremental R&D investment to support the advancement of ProfoundBio's clinical programs, primarily Rina-S. Genmab's revenue guidance is unchanged and expected to be in the previously disclosed guidance range of DKK 18.7 - 20.5 billion.

We expect to update our guidance no later than in connection with our second quarter 2024 earnings.

Revenue

Genmab expects its 2024 revenue to be in the range of DKK 18.7 - 20.5 billion, compared to DKK 16.5 billion in 2023. Our revenue in 2023 was driven primarily by DARZALEX royalties due to the continued strong growth of DARZALEX net sales, partially offset by negative exchange rate movements between the USD and DKK and the negative impact of applying the DARZALEX contractual annual Currency Hedge Rate.

Genmab's projected revenue growth for 2024 is driven by higher royalties, net product sales and collaboration revenue. Royalty growth relates mainly to DARZALEX and Kesimpta net sales growth. Net product sales and collaboration revenue growth are driven by strong performance for both Tivdak and EPKINLY. Net product sales and collaboration revenue consists of EPKINLY net product sales in the U.S. and Japan, and Tivdak (50% gross profit share) in the U.S.

Genmab's projected revenue for 2024 primarily consists of DARZALEX royalties of DKK 12.6 - 13.3 billion. Such royalties are based on estimated DARZALEX 2024 net sales of USD 10.9 - 11.5 billion compared to actual net sales in 2023 of approximately USD 9.7 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.

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Interim Report for the First Quarter of 2024

The remainder of Genmab's revenue consists of royalties from Kesimpta, TEPEZZA®, RYBREVANT®, TECVAYLI®, TALVEY® and TEPKINLY®, net product sales and collaboration revenue from EPKINLY/TEPKINLY and Tivdak, reimbursement revenue and milestones.

Operating Expenses

Genmab anticipates its 2024 operating expenses to be in the range of DKK 12.4 - 13.4 billion, compared to DKK 10.9 billion in 2023. The growth in operating expenses is to support Genmab's continued portfolio advancement and investing for future product launches, including epcoritamab.

Operating Profit

Genmab expects its 2024 operating profit to be in the range of DKK 4.6 - 7.1 billion, compared to DKK 5.3 billion in 2023.

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 2024 guidance assumes a USD / DKK exchange rate of 6.8). The financial guidance assumes that no significant new agreements are entered into during the remainder of 2024 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 2024 Guidance and Key 2024 Priorities in this interim report.

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.

KEY 2024 PRIORITIES

EPKINLY1

Initiate three Phase 3 trials

Expand label to include

Bring Our Own Medicines to Patients

relapsed/refractory FL

Tivdak2

Initiate Phase 3 study in head and neck

cancer

Execute successful launches and growth in key

markets

Acasunlimab (GEN1046/BNT311, DuoBody®-PD-

L1x4-1BB)3

Build World-class Differentiated Pipeline

Initiate Phase 3 study (second line non-

small cell lung cancer (NSCLC))

GEN1042 (DuoBody-CD40x4-1BB)3

Phase 2 data and determine next steps

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Expand and advance proprietary clinical

product portfolio

Invest in Our People & Culture

Further scale organization aligned with

differentiated antibody product portfolio

growth and future launches

Become a Leading Integrated Biotech

Use solid financial base to grow and

Innovation Powerhouse

broaden antibody product and technology portfolio

1. Co-development w/ AbbVie; 2. Co-development w/ Pfizer; 3. Co-development w/ BioNTech

PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST QUARTER OF 2024

At the end of the first quarter of 2024, Genmab's proprietary pipeline of investigational medicines, where we are responsible for at least 50% of development, consisted of ten antibodies 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, and EPKINLY/TEPKINLY, which Genmab is co- developing and co-commercializing in the U.S. and Japan in collaboration with 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 also includes multiple preclinical programs. An overview of the development status of our approved medicines and of each of our investigational medicines is provided in the following section, including updates for the first quarter of 2024. 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 Medicines

Approved Product

Target

Developed By

Disease Indication

EPKINLY

CD3xCD20

Co-development

Approved in multiple

(epcoritamab-bysp,

Genmab/AbbVie

territories including in

epcoritamab)

the U.S. and Europe for

TEPKINLY

adult patients with

relapsed or refractory

(epcoritamab)

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

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refractory large B-cell

lymphoma (LBCL) after

two or more lines of

systemic therapy2

Tivdak

Tissue factor (TF)

Co-development

Approved in the U.S. for

(tisotumab vedotin-tftv)

Genmab/Pfizer

adult patients with

recurrent/metastatic

cervical cancer with

disease progression on

or after chemotherapy2

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.

Pipeline, Including Further Development for Approved Medicines

*Genmab is developing HexaBody-CD38 in an exclusive worldwide license and option agreement with Janssen.

EPKINLY/TEPKINLY (epcoritamab) - Approved in territories including the U.S., Europe, and Japan

  • SC bispecific antibody created using Genmab's DuoBody technology platform
  • Epcoritamab (approved as EPKINLY and TEPKINLY) has received regulatory approvals in multiple territories; see local prescribing information for specific indications and safety information

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  • These approvals were based on data from the relapsed/refractory LBCL cohort of the pivotal EPCORE™ NHL-1 trial (NCT03625037). The approval in Japan was also based on the EPCORE NHL-3 trial (NCT04542824)
  • Regulatory submissions for epcoritamab for the treatment of relapsed/refractory FL are currently under review in the U.S., Europe, and Japan
  • Multiple clinical trials are ongoing across different settings and histologies, including four Phase 3 trials, with more trials in planning
  • Co-developedand 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-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 precise indications. 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 four ongoing Phase 3 trials and additional trials in planning.

Please consult theU.S. Prescribing Informationfor EPKINLY and theEuropean Summary of Product Characteristicsfor TEPKINLY for the labeled indication and safety information.

First Quarter 2024 Updates

  • March: Genmab submitted a supplemental Japan New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare in Japan for SC EPKINLY for the treatment of relapsed or refractory FL after two or more lines of systemic therapy. The application was supported by data from the FL cohort of the EPCORE NHL-1 trial and the EPCORE NHL-3 trial.
  • February: The U.S. FDA granted Priority Review for the sBLA for epcoritamab-bysp for the treatment of adult patients with relapsed or refractory FL after two or more lines of systemic therapy. The U.S. FDA has assigned a PDUFA target action date of June 28, 2024. The submission was supported by data from the FL cohort of the EPCORE NHL-1 trial.
  • February: A new Phase 3 clinical trial was initiated, evaluating the safety and efficacy of SC epcoritamab in combination with rituximab and lenalidomide compared to chemoimmunotherapy in previously untreated FL (EPCORE FL-2, NCT06191744).
  • February: Multiple data presentations, including oral presentations, at the 21st Annual Meeting of the Japanese Society of Medical Oncology (JSMO).

Tivdak (tisotumab vedotin-tftv) - First and only U.S. FDA approved ADC for recurrent or metastatic cervical cancer

  • An ADC directed to TF, a protein highly prevalent in solid tumors, including cervical cancer, which is associated with poor prognosis
  • Accelerated approval granted by the U.S. FDA for tisotumab vedotin-tftv, marketed as Tivdak, as the first and only approved ADC for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
  • U.S. FDA accelerated approval was based on data from the innovaTV 204 (NCT03438396) clinical trial

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  • Regulatory submissions for tisotumab for the treatment of recurrent or metastatic cervical cancer are currently under review in both the U.S. and in Europe, based on a confirmatory Phase 3 trial (innovaTV 301, NCT04697628)
  • Clinical trials in other solid tumors are ongoing
  • Co-developedglobally and co-promoted in the U.S. in collaboration with Pfizer

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 to the antibody. Genmab used technology licensed from Medarex to generate the TF antibody forming part of tisotumab vedotin. Tisotumab vedotin-tftv, marketed as Tivdak, is the first and only U.S. FDA approved ADC for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. 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 will lead commercial operational activities in Japan. Pfizer is leading commercial operational activities in the U.S. and will lead commercial operational activities in Europe and China. In these four markets there will be a 50:50 profit split. In other markets, Pfizer will commercialize Tivdak and Genmab will receive royalties based on a percentage of aggregate net sales ranging from the mid-teens to the mid-twenties. The companies have joint decision- making power on the worldwide development and commercialization strategy for Tivdak. The companies have additional ongoing clinical trials for Tivdak, including a confirmatory Phase 3 trial in recurrent or metastatic cervical cancer, which is the basis of regulatory submissions in both the U.S. and in Europe. The innovaTV 301 China extension trial (ZL-1309-002, NCT05866354) is also ongoing, in collaboration with Zai Lab Limited under their agreement with Pfizer.

Please consult the U.S. Prescribing Informationfor Tivdak for the labeled indication and safety information, including the boxed warning.

First Quarter 2024 Updates

  • March: The U.S. National Comprehensive Cancer Network® (NCCN®) updated their Clinical Practice Guidelines in Oncology for Vaginal Cancer to include tisotumab vedotin-tftv under "Other Recommended Regimens" as second-line or subsequent systemic therapy for patients with recurrent or metastatic squamous cell carcinoma/adenocarcinoma primary vaginal cancer.
  • March: Multiple data presentations, including a late-breaking oral presentation, at the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting.
  • February: The European Medicines Agency validated for review the marketing authorization application of tisotumab vedotin for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy.
  • January: The U.S. FDA accepted the sBLA seeking to convert the accelerated approval of Tivdak to full approval for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy. The application was granted Priority Review with a PDUFA action date of May 9, 2024.

Acasunlimab (GEN1046/BNT311) - Bispecific next-generation immunotherapy

  • Bispecific antibody targeting PD-L1 and 4-1BB, created using Genmab's DuoBody technology platform
  • Clinical trials in solid tumors ongoing
  • Co-developedin collaboration with BioNTech

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Genmab A/S published this content on 02 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 02 May 2024 15:09:03 UTC.