Steven Mah

Steven Mah asked about strategies to increase IBTROZI's first-line penetration against crizotinib, including engaging regulators for NCCN guideline preference. He also requested an update on the BET inhibitor NUV-868 and clarification on whether a head-to-head trial versus Xalkori is still required for IBTROZI's European approval.

Answer

David Hung, Founder, President, and CEO of Nuvation Bio, stated that using crizotinib in the first-line setting is inappropriate due to its lack of CNS coverage, given the high propensity for brain metastases in ROS1-positive NSCLC. He confirmed that Nuvation Bio is exploring strategies to ensure IBTROZI's differentiation is reflected in NCCN guidelines. Colleen Sjogren, CCO, added that the team is focused on expanding the market through education on comprehensive genetic testing. Hung mentioned interest in NUV-868 and that options are being explored. For European approval, Hung indicated that no additional clinical trials are believed to be needed, with more details to follow upon MA submission.

Steven Mah from TD Cowen asked about strategies for increasing IBTROZI's first-line penetration, particularly against crizotinib's entrenchment, and whether Nuvation Bio has engaged regulators to seek a preference in NCCN guidelines. He also requested an update on the BET inhibitor NUV-868 and clarification on the European approval process for IBTROZI, specifically if a head-to-head trial versus Xalkori is no longer required.

Answer

CEO David Hung stated that using crizotinib in the first-line setting is inappropriate due to its lack of CNS coverage, given the high propensity for brain metastases in ROS1-positive NSCLC, and that educating KOLs and patients on CNS coverage is a main message. He confirmed Nuvation Bio is exploring strategies to have IBTROZI's differentiated performance reflected in NCCN guidelines. CCO Colleen Sjogren added that the team is focused on expanding the market by ensuring appropriate genetic testing (tissue and liquid biopsies) before treatment decisions. Dr. Hung mentioned that there has been interest in NUV-868 and Nuvation Bio is 'looking at all our options.' For European approval, Dr. Hung stated that no additional clinical trials are believed to be needed, with more details to follow MA submission.

Asked for confirmation on the Total Health rollout timeline, the reasons for its delay, and how the company is managing cash burn while funding its therapeutics business.

Answer

The Total Health rollout to existing customers is confirmed for calendar Q3; the delay is due to engineering priorities. The company is managing cash burn through cost reductions in its Consumer & Research segments while funding specific clinical trial phases for its key therapeutic assets to extend its cash runway.

Asked for details on the Just-Evotec Biologics €1 billion order book, how it compares to projections, and if the macro environment has affected plans for future J.POD expansion.

Answer

The €1 billion order book consists of committed work, a significant increase from previous projections of around €100 million, providing a strong runway for the next few years. The plan for J.PODs remains focused on the US and Europe (Toulouse), as their high productivity provides sufficient capacity for the near term.