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Genmab 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Genmab Announces Financial Results for the First Half of 2024
August 8, 2024 Copenhagen, Denmark;
Interim Report for the First Six Months Ended June 30, 2024
"In the second quarter of 2024, we reached a number of significant milestones for the company. The acquisition of ProfoundBio, along with the regulatory approvals for EPKINLY and Tivdak, further solidify our commitment to the development of differentiated antibody therapies and will advance Genmab towards our ambitious 2030 vision of transforming the lives of patients with our innovative antibody medicines," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Half of 2024
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Carl Jacobsens Vej 30 | www.genmab.com | Page 1/47 |
| 2500 Valby, Denmark | CVR no. 2102 3884 |
Genmab Announces Financial Results for the First Half of 2024
Significant Event Post-quarter End
As announced in Company Announcement No. 52, Genmab is updating its 2024 financial guidance.
| Revised | Revised | ||||
| Guidance | Guidance | ||||
| (DKK million) | ex. Acquisition and Integration related charges | incl. Acquisition and Integration related charges | Previous Guidance | ||
| Revenue | 20,500 - 21,700 | 20,500 - 21,700 | 18,700 - 20,500 | ||
| Royalties | 16,600 - 17,400 | 16,600 - 17,400 | 15,600 - 16,700 | ||
| Net product sales/Collaboration revenue* | 2,000 - 2,200 | 2,000 - 2,200 | 1,700 - 2,200 | ||
| Milestones/Reimbursement revenue | 1,900 - 2,100 | 1,900 - 2,100 | 1,400 - 1,600 | ||
| Gross profit** | 19,600 - 20,800 | 19,600 - 20,800 | 18,000 - 19,500 | ||
| Operating expenses** | (13,700) - (14,300) | (14,100) - (14,700) | (12,400) - (13,400) | ||
| Operating profit | 5,300 - 7,100 | 4,900 - 6,700 | 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 will hold a conference call to discuss the results for the first half of 2024 today, August 8, 2024, 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
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Carl Jacobsens Vej 30 | www.genmab.com | Page 2/47 |
| 2500 Valby, Denmark | CVR no. 2102 3884 |
Genmab Announces Financial Results for the First Half of 2024
personal PIN: https://register.vevent.com/register/BI61134ed097674233a89964e3bc06a69e. 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
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Carl Jacobsens Vej 30 | www.genmab.com | Page 3/47 |
| 2500 Valby, Denmark | CVR no. 2102 3884 |
Interim Report for the First Half of 2024
| MANAGEMENT'S REVIEW | |
| CONSOLIDATED KEY FIGURES | 5 |
| OUTLOOK | 6 |
| KEY 2024 PRIORITIES | 7 |
| PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST HALF OF 2024 | 8 |
| SIGNIFICANT RISKS AND UNCERTAINTIES | 19 |
| FINANCIAL REVIEW | 20 |
| CONDENSED FINANCIAL STATEMENTS | 28 |
| NOTES TO THE CONDENSED FINANCIAL STATEMENTS | 32 |
| ABOUT GENMAB | 46 |
| DIRECTORS' AND MANAGEMENT'S STATEMENT ON THE INTERIM REPORT | 47 |
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Carl Jacobsens Vej 30 | www.genmab.com | Page 4/47 |
| 2500 Valby, Denmark | CVR no. 2102 3884 |
Interim Report for the First Half of 2024
CONSOLIDATED KEY FIGURES
| Three Months Ended | Six Months Ended | |||||||||||||
| (DKK million) | June 30, | June 30, | Full Year | |||||||||||
| Income Statement | 2024 | 2023 | 2024 | 2023 | 2023 | |||||||||
| Revenue | 5,402 | 4,169 | 9,545 | 7,003 | 16,474 | |||||||||
| Cost of product sales | (190) | (21) | (375) | (21) | (226) | |||||||||
| Research and development expenses | (2,502) | (1,853) | (4,801) | (3,594) | (7,630) | |||||||||
| Selling, general and administrative expenses | (894) | (827) | (1,676) | (1,503) | (3,297) | |||||||||
| Acquisition and integration related charges | (176) | - | (252) | - | - | |||||||||
| Total costs and operating expenses | (3,762) | (2,701) | (7,104) | (5,118) | (11,153) | |||||||||
| Operating profit | 1,640 | 1,468 | 2,441 | 1,885 | 5,321 | |||||||||
| Net financial items | 487 | 226 | 1,402 | 75 | 316 | |||||||||
| Net profit | 1,408 | 1,335 | 2,733 | 1,545 | 4,352 | |||||||||
| Balance Sheet | ||||||||||||||
| Marketable securities | 11,402 | 14,010 | 11,402 | 14,010 | 13,268 | |||||||||
| Cash and cash equivalents | 4,331 | 10,874 | 4,331 | 10,874 | 14,867 | |||||||||
| Total non-current assets | 16,682 | 2,229 | 16,682 | 2,229 | 2,150 | |||||||||
| Total assets | 38,619 | 31,781 | 38,619 | 31,781 | 35,289 | |||||||||
| Shareholders' equity | 30,969 | 28,558 | 30,969 | 28,558 | 31,610 | |||||||||
| Share capital | 66 | 66 | 66 | 66 | 66 | |||||||||
| Cash Flow Statement | ||||||||||||||
| Cash flow from operating activities | 1,513 | 436 | 3,026 | 3,671 | 7,380 | |||||||||
| Cash flow from investing activities | (8,772) | (1,835) | (10,213) | (1,848) | (1,282) | |||||||||
| Cash flow from financing activities | (3,051) | 7 | (3,646) | (604) | (606) | |||||||||
| Investment in intangible assets | - | (10) | - | (10) | (10) | |||||||||
| Investment in tangible assets | (27) | (97) | (55) | (201) | (366) | |||||||||
| Financial Ratios and Other Information | ||||||||||||||
| Basic net profit per share | 21.85 | 20.46 | 42.13 | 23.66 | 66.64 | |||||||||
| Diluted net profit per share | 21.70 | 20.28 | 41.85 | 23.45 | 66.02 | |||||||||
| Period-end share market price | 1,745 | 2,580 | 1,745 | 2,580 | 2,155 | |||||||||
| Price / book value | 3.72 | 5.96 | 3.72 | 5.96 | 4.50 | |||||||||
| Shareholders' equity per share | 469.23 | 432.70 | 469.23 | 432.70 | 478.94 | |||||||||
| Equity ratio | 80 | % | 90 | % | 80 | % | 90 | % | 90 | % | ||||
| Shares outstanding | 66,136,909 | 66,038,425 | 66,136,909 | 66,038,425 | 66,074,535 | |||||||||
| Average number of employees (FTE*) | 2,449 | 1,968 | 2,358 | 1,882 | 2,011 | |||||||||
| Number of employees (FTE) at the end of the period | 2,526 | 2,015 | 2,526 | 2,015 | 2,204 |
* Full-time equivalent or team members
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Carl Jacobsens Vej 30 | www.genmab.com | Page 5/47 |
| 2500 Valby, Denmark | CVR no. 2102 3884 |
Interim Report for the First Half of 2024
| Revised | Revised | ||||
| Guidance | Guidance | ||||
| (DKK million) | ex. Acquisition and Integration related charges | incl. Acquisition and Integration related charges | Previous Guidance | ||
| Revenue | 20,500 - 21,700 | 20,500 - 21,700 | 18,700 - 20,500 | ||
| Royalties | 16,600 - 17,400 | 16,600 - 17,400 | 15,600 - 16,700 | ||
| Net product sales/Collaboration revenue* | 2,000 - 2,200 | 2,000 - 2,200 | 1,700 - 2,200 | ||
| Milestones/Reimbursement revenue | 1,900 - 2,100 | 1,900 - 2,100 | 1,400 - 1,600 | ||
| Gross profit** | 19,600 - 20,800 | 19,600 - 20,800 | 18,000 - 19,500 | ||
| Operating expenses** | (13,700) - (14,300) | (14,100) - (14,700) | (12,400) - (13,400) | ||
| Operating profit | 5,300 - 7,100 | 4,900 - 6,700 | 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
As announced in Company Announcement No. 52, Genmab is updating revenue, operating expenses and operating profit guidance for 2024. The revised guidance reflects an updated revenue outlook, incremental R&D investment to support the advancement of ProfoundBio's clinical programs, primarily Rina-S, as well as acquisition and integration related charges.
Genmab currently expects 2024 revenue to be in the range of DKK 20.5 - 21.7 billion. Our projected increase in revenue for 2024 as compared to our previous guidance is driven by higher royalties and reimbursement revenue.
Royalty growth relates mainly to DARZALEX and Kesimpta net sales growth. DARZALEX royalties of DKK 13.3 - 13.8 billion are based on Genmab's estimate of DARZALEX 2024 net sales of USD 11.4 - 11.8 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 now anticipates its 2024 operating expenses (excluding acquisition and integration related charges) to be in the range of DKK 13.7 - 14.3 billion, an increase to the previous guidance of DKK 12.4 - 13.4 billion. The increase primarily relates to the incremental R&D investment to support the advancement of ProfoundBio's clinical programs, primarily Rina-S as well as a revenue and expense classification change for programs that remain in Genmab's collaboration with BioNTech. This classification change has resulted in Genmab increasing both cost reimbursement revenue and operating expense by approximately DKK 600 million, resulting in no impact on operating profit. Excluding the DKK 600 million related to the classification change and the acquisition and integration charges, the underlying operating expense range remains within the directional financial guidance provided at the time we announced the ProfoundBio acquisition.
Including acquisition and integration related charges, Genmab expects operating expenses for 2024 to be in the range of DKK 14.1 - 14.7 billion.
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Carl Jacobsens Vej 30 | www.genmab.com | Page 6/47 |
| 2500 Valby, Denmark | CVR no. 2102 3884 |
Interim Report for the First Half of 2024
Genmab now expects its 2024 operating profit excluding acquisition and integration related charges to be in the range of DKK 5.3 - 7.1 billion, compared to the previous guidance of DKK 4.6 - 7.1 billion, primarily driven by the items described above.
Including acquisition and integration related charges, Genmab expects operating profit for 2024 to be in the range of DKK 4.9 - 6.7 billion.
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.
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.
| Bring Our Own Medicines to Patients | EPKINLY 1 Initiate three Phase 3 trials Expand label to include relapsed/refractory FL |
| Tivdak 2 Initiate Phase 3 study in head and neck cancer | |
| Execute successful launches and growth in key markets | |
| Build World-class Differentiated Pipeline | Acasunlimab (GEN1046, DuoBody -PD-L1x4-1BB) Initiate Phase 3 study (second line non-small cell lung cancer (NSCLC)) |
| GEN1042 (DuoBody-CD40x4-1BB) 3 Phase 2 data and determine next steps | |
| 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 Innovation Powerhouse | Use solid financial base to grow and broaden antibody product and technology portfolio |
1. Co-development w/ AbbVie; 2. Co-development w/ Pfizer Inc. (Pfizer); 3. Co-development w/ BioNTech SE (BioNTech)
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Carl Jacobsens Vej 30 | www.genmab.com | Page 7/47 |
| 2500 Valby, Denmark | CVR no. 2102 3884 |
Interim Report for the First Half of 2024
PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST HALF OF 2024
At the end of the first half of 2024, Genmab's proprietary pipeline of investigational medicines, where we are responsible for at least 50% of development, consisted of thirteen 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, 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 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 second quarter of 2024. For events that occurred during the first quarter of 2024, please refer to Genmab's Q1 2024 report. 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 |
| 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 2 |
| Approved in the U.S. for adult patients with relapsed or refractory FL after two or more lines of systemic therapy 2 | |||
| Tivdak (tisotumab vedotin-tftv) | Tissue factor (TF) | Co-development Genmab/Pfizer | Approved in the U.S. for adult patients with recurrent/metastatic cervical cancer with disease progression on or after chemotherapy 2 |
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.
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Carl Jacobsens Vej 30 | www.genmab.com | Page 8/47 |
| 2500 Valby, Denmark | CVR no. 2102 3884 |
Interim Report for the First Half of 2024
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) - First and only bispecific antibody approved in the U.S. to treat both relapsed or refractory FL and DLBCL after two or more lines of systemic therapy
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
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Carl Jacobsens Vej 30 | www.genmab.com | Page 9/47 |
| 2500 Valby, Denmark | CVR no. 2102 3884 |
Interim Report for the First Half of 2024
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 the U.S. Prescribing Information for EPKINLY and the European Summary of Product Characteristics for TEPKINLY for the labeled indication and safety information.
Second Quarter 2024 Updates
Oncology (ASCO) Annual Meeting including two rapid oral presentations. These presentations highlighted data from the pivotal and cycle 1 dose optimization cohorts of the EPCORE NHL-1 clinical trial, which was subsequently selected for presentation at the Best of ASCO conference, and epcoritamab in combination with rituximab and lenalidomide in patients with previously untreated FL from the EPCORE NHL-2 (NCT04663347) clinical trial.
Tivdak (tisotumab vedotin-tftv) - First and only U.S. FDA approved antibody-drug conjugate (ADC) for recurrent or metastatic cervical cancer
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
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Carl Jacobsens Vej 30 | www.genmab.com | Page 10/47 |
| 2500 Valby, Denmark | CVR no. 2102 3884 |
Interim Report for the First Half of 2024
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. Please consult the U.S. Prescribing Information for Tivdak for the labeled indication and safety information, including the boxed warning.
Second Quarter 2024 Updates
Acasunlimab (GEN1046) - Bispecific next-generation immunotherapy
Acasunlimab (GEN1046, DuoBody-PD-L1x4-1BB) is a proprietary bispecific antibody, created using Genmab's DuoBody technology platform. It was being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and future potential profits for acasunlimab on a 50:50 basis. In August 2024, Genmab assumed sole responsibility for the continued development and potential commercialization of acasunlimab. BioNTech has opted not to participate in the further development of the acasunlimab program under the parties' existing collaboration agreement. The program will be subject to payment of certain milestones and a tiered single-digit royalty on net sales by Genmab to BioNTech. While the emerging clinical profile of acasunlimab is encouraging, BioNTech informed the company that it has taken this decision for reasons relating to its portfolio strategy. 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. Acasunlimab is currently in Phase 2 clinical development. Based on encouraging data from the Phase 2 trial in NSCLC (NCT05117242), a Phase 3 trial is expected to start before the end of 2024.
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Carl Jacobsens Vej 30 | www.genmab.com | Page 11/47 |
| 2500 Valby, Denmark | CVR no. 2102 3884 |
Interim Report for the First Half of 2024
Second Quarter 2024 Update
Rinatabart Sesutecan (Rina-S, GEN1184) - Potential best-in-class folate receptor alpha (FR )-targeted TOPO1 ADC
Rina-S is a novel FR -targeted TOPO1 ADC being evaluated for the potential treatment of ovarian cancer and other FR -expressing cancers. Dose escalation 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 U.S. FDA for the treatment of FR -expressing high-grade serous or endometrioid platinum-resistant ovarian cancer. A Phase 1/2 trial of Rina-S in advanced solid tumors is ongoing. Based on encouraging data from this trial, a Phase 3 trial in second line plus platinum resistant ovarian cancer is expected to start before the end of 2024.
GEN1042 (BNT312) - Potential first-in-class bispecific agonistic antibody
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.
GEN3014 - HexaBody-based investigational medicine with potential in hematological malignancies
GEN3014 (HexaBody-CD38) is a human CD38 monoclonal antibody-based investigational medicine created using Genmab's HexaBody technology platform. GEN3014 is a second generation CD38-targeting lgG1 antibody with a hexamerization-enhancing modification. GEN3014 is designed to induce antitumor activity through highly potent complement-dependent cytotoxicity (CDC) and antitumor activity, which is enhanced compared to daratumumab as demonstrated in previously presented preclinical data and is effective at a wider range of target expression levels. In June 2019, Genmab entered into an exclusive worldwide license and option agreement with Janssen to develop and commercialize GEN3014. A Phase 1/2 clinical trial in hematologic malignancies is ongoing and includes a cohort comparing GEN3014 to daratumumab in CD38 monoclonal antibody-na ve relapsed or refractory multiple myeloma patients.
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| Carl Jacobsens Vej 30 | www.genmab.com | Page 12/47 |
| 2500 Valby, Denmark | CVR no. 2102 3884 |
Interim Report for the First Half of 2024
GEN1047 - Bispecific antibody with potential in solid tumors
GEN1047 (DuoBody-CD3xB7H4) is a bispecific antibody-based investigational medicine created using Genmab's DuoBody technology platform. B7H4 is a tumor-associated antigen expressed on malignant cells in various solid cancers including breast, ovarian and lung cancer. In preclinical studies, GEN1047 induced T-cell mediated cytotoxicity of B7H4-positive tumor cells. GEN1047 is being developed for the potential treatment of solid cancer indications known to express B7H4. A Phase 1/2 clinical trial of GEN1047 in malignant solid tumors is ongoing and currently in the dose-expansion phase.
GEN3017 - DuoBody-based investigational therapy in the clinic
GEN3017 (DuoBody-CD3xCD30) is a bispecific antibody-based investigational medicine created using Genmab's DuoBody technology platform. CD30 is highly expressed in multiple hematologic malignancies, including classical Hodgkin lymphoma and anaplastic large cell lymphoma. In preclinical studies, GEN3017 induced potent T-cell mediated cytotoxicity of CD30-expressing tumor cells, which was associated with induction of CD4+ and CD8+ T-cell activation, proliferation, and cytokine production. GEN3017 is being developed for the potential treatment of certain hematological malignancies. A Phase 1/2 clinical trial of GEN3017 in relapsed or refractory classical Hodgkin lymphoma and NHL is ongoing.
GEN1059 (BNT314) - Bispecific antibody with potential in solid tumors
GEN1059 (DuoBody-EpCAMx4-1BB, BNT314), jointly owned by Genmab and BioNTech and created using Genmab's DuoBody technology platform, is a proprietary bispecific antibody aimed at boosting antitumor immune responses through EpCAM-dependent 4-1BB agonistic activity. GEN1059 is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and future potential profits for GEN1059 on a 50:50 basis. A Phase 1/2 clinical trial of GEN1059 in solid tumors is ongoing.
GEN1055 (BNT315) - HexaBody-based antibody with potential in solid tumors
GEN1055 (HexaBody-OX40, BNT315), jointly owned by Genmab and BioNTech and created using Genmab's HexaBody technology platform, is an immune-modulating OX40 agonist antibody that promotes immunity by inducing T-cell responses through Fc R-independent OX40 clustering on T cells. GEN1055 is being co-developed by Genmab and BioNTech under an agreement in which the companies
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Carl Jacobsens Vej 30 | www.genmab.com | Page 13/47 |
| 2500 Valby, Denmark | CVR no. 2102 3884 |
Interim Report for the First Half of 2024
share all costs and future potential profits for GEN1055 on a 50:50 basis. A Phase 1/2 clinical trial of GEN1055 in solid tumors is ongoing.
Second Quarter 2024 Update
GEN1160 - ADC with potential in both solid tumors and hematological malignancies
GEN1160 is a CD70-targeted ADC. CD70 is a protein expressed on both solid tumors and hematological malignancies. A Phase 1/2 clinical study of GEN1160 in advanced renal cell carcinoma, nasopharyngeal carcinoma and NHL is ongoing.