Kripa Devarakonda • Truist Securities

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CEO Nello Mainolfi explained the CDK2 program was partnered to align with Kymera's immunology focus. He highlighted its differentiation through high specificity over CDK1 and brain penetrance. CMO Jared Gollob and Nello Mainolfi confirmed the Q4 data will show the kinetics of itch relief, with measurements at days 7, 14, 21, and 28.

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CEO Carl Hansen detailed the trial design, stating the SAD/MAD phases would enroll about 56-60 participants, while the proof-of-concept phase will enroll up to 80 postmenopausal women. He reiterated that the NKTR class targets a population where HRT is contraindicated or not preferred, representing a substantial and distinct market opportunity.

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CMO Noah Berkowitz explained that while LRRK2 mutations are present in a subset of familial and idiopathic Parkinson's patients, pathway perturbations are much broader, potentially implicating 30% or more of patients. The company is actively exploring patient selection strategies. Regarding Vepdeq, he reiterated that while there is every reason to believe it could be effective in earlier lines, the decision was made with Pfizer not to pursue those studies at this time, reinforcing the strategy to renegotiate or find a new partner.

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CMO Noah Berkowitz reported that after a slow start, enrollment for the ARV-393 Phase 1 trial is now steady with a backlog of patients. He sees potential for the drug as both a monotherapy and in combination, particularly with bispecifics. CEO John Houston added that Arvinas has not experienced any FDA-related delays but continues to monitor the situation.

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CEO David Hallal stated it is difficult to predict FDA actions but emphasized the company's focus is on submitting a "robust response" to the observations, which could influence the need for a re-inspection. He reiterated that the positive late-cycle meeting held after the observations were issued provides confidence that the FDA is working toward the September 22 PDUFA date.

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Executive Jay Backstrom explained that after establishing the right dose for SRK-439, they envision studies with enriched patient subgroups to demonstrate impact on endpoints like HbA1c, which is a clear regulatory path. For functional measures, he stated they are not committed to any specific test yet and plan to engage the FDA on meaningful functional endpoints after the IND is open, using early clinical data to inform the design of a registration program.

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Executive Jay Backstrom responded that the FDA typically views SMA as a single disease continuum and has granted broad labels to other therapies without restrictions on ambulatory status. He anticipates a similar broad labeling approach for apitegromab. He also noted that European regulators seem to share this view, which is reinforced by the drug's PRIME designation. While labeling is negotiated late in the approval process, he expressed strong confidence in their position for a broad label based on the strength of the SAPPHIRE data.

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EVP & Head of U.S. Oncology Mohamed Issa identified PV as Jakafi's biggest growth driver due to being the least penetrated indication, with a focus on educating about earlier use. For Monjuvy in FL, he expects a gradual ramp due to the disease's indolent nature but sees potential for it to become a new standard of care and a significant incremental growth driver.

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Executive Daniel Skovronsky stated that to show a benefit, the combination would likely need to demonstrate either incremental weight loss or a tangible functional benefit from lean mass preservation. He said it is a 'safe assumption' that data from the completed Phase II study will be shared this year.

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CCO Adam Lenkowsky explained that the Camzyos label update should increase capacity at Centers of Excellence, supporting continued growth, which will be further boosted by upcoming ODYSSEY data. He also stated that the reported pharmacy issue with Cobenfy was likely a one-off, as the company is not aware of broad availability problems. CMO Samit Hirawat directed analysts to a recent publication for details on the ODYSSEY trial design.

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CEO Matt Foehr expressed confidence in the company's current business model, stating he sees no change. He emphasized that partners specifically seek out OmniAb for its advanced discovery technologies to generate novel antibodies, a core function they are not moving away from. Foehr reiterated that the business model is purposely designed to be resilient through various industry cycles.

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