GENMAB A/S earnings calls

timing and recruitment for Peto trial

Q (Zain Ebrahim · JPMorgan): They asked why the petosemtamab second-line trial readout moved to Q1 2027, and whether the change was due to endpoint change or upsizing; also asked how recruitment is progressing and about DLBCL-4 overall survival and FDA feedback on confirmatory trial choice.

A: The Peto second-line trial is event driven on overall survival, so the updated top-line timing is based on what they now expect for events; the DLBCL-4 OS is immature and not yet reported; engagement with the agency is ongoing on which trial will be confirmatory.

"As you correctly noted, the endpoint is over survival, so this is an event driven, projection." — Tahamtan Ahmadi

delay of EPCORE DLBCL-2 interim

Q (Michael Schmidt · Guggenheim Partners): Why was the interim analysis for EPCORE DLBCL-2 delayed about a year despite faster-than-expected enrollment?

A: They said they are excited for the upcoming readout next quarter and confirmed the interim will be top-line next quarter; once they have the data they will discuss details and any follow-up questions.

"We are very excited what the results of this trial as they are going to read out next quarter." — Tahamtan Ahmadi

first-line DLBCL interim OS and filings

Q (James Gordon · Barclays): How mature will interim OS be for the first-line DLBCL trial in Q4, is first-line or refractory a higher bar, will you announce if interim fails, and will both PROC Phase II and III readouts be shown?

A: They said they will present an interim that they expect to use as a basis for filing next quarter for the frontline PETO trial but would not speculate on statistical significance; Phase II and Phase III PROC datasets will both be made available when top-line results are ready.

"we will have an interim data that we expect to be the basis for filing." — Tahamtan Ahmadi

what Peto must show to compete

Q (Truist): With competitors moving fast in second/third-line head and neck, what efficacy and durability would Peto need to remain competitive?

A: They said Peto appears best-in-class among second-generation EGFR bispecifics based on available data across settings, and that the combination of frontline and monotherapy trials will form a comprehensive dataset to support their position in head and neck.

"we believe Peto is the best in class second generation EGFR bispecific based on all the data that we have seen in head and neck" — Tahamtan Ahmadi

EPKINLY trial comparisons and Peto combo choice

Q (Xian Deng · UBS): Why might R-CHOP performance differ from historic trials for EPKINLY frontline, and why is the Peto frontline trial chemo-free with pembrolizumab rather than with chemo?

A: They said cross-trial comparisons of control arms are limited and they have no visibility to R-CHOP behavior; for Peto-pembro they noted head and neck patients can be fragile and phase 2 Peto-pembro showed much higher response and durability versus chemo-pembro, supporting the chemo-free design.

"our anticipation is that Peto-pembro is going to provide a truly very significant and important dataset for patients with head and neck" — Tahamtan Ahmadi

EPKINLY phase2 vs frontline and endometrial

Q (Rajan Sharma · Goldman Sachs): Did second-line EPKINLY data exceed internal expectations and raise confidence for frontline, and does Merck's Trop-2 ADC PFS/OS result change the bar for Rina-S in endometrial cancer?

A: They said phase 2 results have been predictive and give confidence for frontline; Merck's Trop-2 result has little bearing on Rina-S strategy, Rina shows efficacy across a spectrum of receptor alpha expression, and they have initiated two Phase III trials in endometrial as planned.

Peto differentiation in colorectal and combos

Q (Eva Fortea-Verdejo): How is petosemtamab's colorectal strategy differentiated from competitors like amivantamab, and would combining Peto with RAS-directed therapies be viable?

A: They said colorectal phase 2 data show impressive ORR and durability and that Peto appears to have higher response and better safety than amivantamab across datasets; they are pursuing combinations and are engaging on RAS-directed combinations with more to come.

"it appears to have higher response rate and a better safety profile than, for example, amivantamab." — Tahamtan Ahmadi

competitive filing and why Peto outperforms

Q (Suzanne van Voorthuizen · Kempen): Did J&J's accelerated approval plan change Genmab's filing or commercial strategy for Peto, and what drives confidence that Peto is best-in-class versus amivantamab?

A: They said J&J's accelerated path does not change their plans; they expect a comprehensive dataset from frontline and OS readouts, and they see Peto outperforming amivantamab on efficacy across multiple datasets and having a differentiated safety profile, possibly due to different antibodies/mechanisms.

"In all 4 of these datasets, actually. Peto outperforms amivantamab. On the efficacy." — Tahamtan Ahmadi

differences between PROC trials and PFS expectations

Q (Charlie Haywood · BofA): Are there differences between the Phase II and Phase III PROC trials in recruitment or cohorts, and what PFS improvement versus PLD would be clinically meaningful for the Phase III?

A: They said the inclusion/exclusion criteria are largely similar so Phase II should read across to Phase III but phase 3 has broader footprint; they would not speculate numerically but highlighted Rina-S has shown over 50% response and long durability driven by low discontinuation, implying meaningful PFS directionally.

"it shows a very high response rate of 50%, plus 50, which is probably more important a very long durability of response." — Tahamtan Ahmadi

Peto upsizing and trial powering

Q (Yaron Werber · TD Cowen): When the Peto frontline study was upsized, did the powering assumptions change, and are you enrolling a representative HPV negative/positive mix; also will you pursue a pembro combination Phase III?

A: They said the upsizing was done to increase probability of success and to ensure proper power for subgroup analyses, a decision made during diligence and executed early; more Peto head and neck trials and activities will be announced when patients are dosing.

"This was purely driven to ensure that we have the proper power for all kinds of subgroup analyses." — Tahamtan Ahmadi

Rina-S competition and I&I interest

Q (Benjamin Jackson): Could topo I resistance emerging from competitors affect Rina-S commercial opportunity, and any updates on EPKINLY potential in immunology and inflammation (I&I)?

A: They said several Phase III trials are ongoing and they are working to move Rina into earlier lines; topo I resistance would be a post-Rina issue if they are first; I&I is not the current priority as cancer is the focus with Q4 readouts coming.

"we are constantly actively working on moving essentially the entry point for Rina into earlier lines." — Tahamtan Ahmadi

what Q4 top-line will include

Q (Judah Frommer · Morgan Stanley): For Peto frontline Q4 update, will the top-line include subgroup data like HPV status or will that come later?

A: They said Genmab top-line releases historically focus on the primary endpoint and that is what will happen for Peto; more granular subgroup and nuanced data will be shared later at a public presentation or conference.

"top line results in Genmab have historically focused on the primary endpoint." — Tahamtan Ahmadi

EPKINLY stocking and patent timeline

Q (Victor Floch): Is there any stocking to factor into EPKINLY modeling and can you comment on IP and patent life assumptions for EPKINLY?

A: They said there is no stocking issue at this time; on IP they declined detailed discussion but stated their current assumption is mid thirties for patent protection and they pursue additional IP to potentially extend protection.

"no stocking issue or no stocking at this point in time to be discussed." — Brad Bailey

timing of frontline DLBCL readout vs original model

Q (Kalpit Patel): Was the Q4 frontline DLBCL readout timing in line with original modeling and did completing enrollment in 2024 shift the estimated timing materially?

A: They declined to discuss detailed timing or modeling assumptions and reiterated the frontline readout will be in Q4 and they are excited about the data.

"The readout will be in Q4." — Jan van de Winkel

CRC frontline trial objectives and Rina-S NSCLC

Q (Matthew Phipps · William Blair): Will the frontline CRC Peto trial explore Project FrontRunner, and any update on Rina-S Phase II in non-small cell lung cancer and timing for data?

A: They said it is fair to assume they will explore Project FrontRunner opportunities in colorectal, and for Rina-S in lung they will present data when they have a dataset and action plan, choosing timing to align with competitive and strategic readiness.

"it is fair to assume that we will also explore if it is opportune Project FrontRunner opportunities, Colorectal for both trials." — Tahamtan Ahmadi