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    Rami Katkhuda • Lifesci Capital

    Rami Katkhuda's questions to Mineralys Therapeutics Inc (MLYS) leadership

    Rami Katkhuda's questions to Mineralys Therapeutics Inc (MLYS) leadership • Q2 2025

    Question

    Rami Katkhuda of LifeSci Capital asked about AstraZeneca's blood pressure measurement methodology and its potential impact on placebo response, and whether the FDA has specified requirements for 52-week safety data for filing.

    Answer

    CEO Jon Congleton stated he was unaware of AstraZeneca's specific methods but highlighted Mineralys's adherence to AHA best practices to control for placebo effect. Regarding the NDA filing, he explained that the FDA does not provide a specific percentage for 52-week patient data, and the goal is to submit a sufficient and appropriate safety database for review.

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    Rami Katkhuda's questions to Mineralys Therapeutics Inc (MLYS) leadership • Q1 2025

    Question

    Rami Katkhuda of LifeSci Capital sought to confirm if the Explore-CKD patient population, characterized by modest proteinuria, differs from that of a competitor's study and whether that competitor's UACR reduction result is a fair benchmark.

    Answer

    Chief Medical Officer Dr. David Rodman and Executive Jon Congleton confirmed key differences. Dr. Rodman explained that their trial targets hypertensive nephropathy, a distinct CKD subset from the metabolic syndrome-driven CKD often associated with higher proteinuria. Mr. Congleton added that their trial's baseline blood pressure inclusion criteria are higher, further distinguishing the populations and making direct UACR comparisons inappropriate.

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    Rami Katkhuda's questions to Mineralys Therapeutics Inc (MLYS) leadership • Q4 2024

    Question

    Rami Katkhuda from LifeSci Capital questioned the expected difference in treatment effect between the ADVANCE and Launch trials and asked for views on a competitor's shorter half-life ASI and lorundrostat's positioning in chronic kidney disease (CKD).

    Answer

    Executive Jon Congleton found it difficult to predict a delta between the trials, noting Advance is more rigorous while Launch is more 'real-world.' Chief Medical Officer Dr. David Rodman suggested that historical data indicates a longer half-life, like lorundrostat's, is preferable for maximal efficacy. He positioned their CKD strategy as focusing on blood pressure control to prevent kidney damage, which their drug's profile is well-suited for, especially in combination with an SGLT2 inhibitor.

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    Rami Katkhuda's questions to Mineralys Therapeutics Inc (MLYS) leadership • Q3 2024

    Question

    Rami Katkhuda of Lifesci Capital asked if recruiting patients with a lower eGFR in the pivotal trials could increase hyperkalemia rates compared to the Target-HTN study. He also inquired if the Launch-HTN trial would include an analysis of compliant versus non-compliant patients.

    Answer

    Executive Jon Congleton stated that based on modest potassium changes in Target-HTN, they were comfortable lowering the eGFR threshold to 45 for the pivotal trials. He noted the Explore-CKD trial, which goes to an eGFR of 30, uses a reduced 25mg dose as a precaution. He also confirmed Launch-HTN will have a prespecified analysis comparing patients with over 75% compliance to those with less, using AiCure technology for tracking.

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    Rami Katkhuda's questions to Viridian Therapeutics Inc (VRDN) leadership

    Rami Katkhuda's questions to Viridian Therapeutics Inc (VRDN) leadership • Q1 2024

    Question

    Rami Katkhuda from LifeSci Capital asked about the company's plans for filing for approval of VRDN-001 in Europe in parallel with the U.S. and inquired about the potential size of the ex-U.S. market opportunity.

    Answer

    President and CEO Stephen Mahoney confirmed that the epidemiology in Europe is very similar to the U.S. and that the company is actively considering its ex-U.S. strategy, including beyond Europe, with more details to be shared at a later date.

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