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    Matthew Caufield • H.C. Wainwright & Co.

    Matthew Caufield's questions to Mineralys Therapeutics Inc (MLYS) leadership

    Matthew Caufield's questions to Mineralys Therapeutics Inc (MLYS) leadership • Q2 2025

    Question

    Matthew Caufield of H.C. Wainwright & Co. asked if there was any reason to believe the FDA might apply extra scrutiny to the serum potassium safety data during the pre-NDA review.

    Answer

    CEO Jon Congleton responded with confidence, stating that the FDA would likely value the comprehensive safety characterization across diverse patient populations (real-world, optimized, and CKD). He believes the thoroughness of the clinical program, which was designed to assess the drug's profile across this spectrum, will be viewed favorably by the agency.

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    Matthew Caufield's questions to Mineralys Therapeutics Inc (MLYS) leadership • Q4 2024

    Question

    Matthew Caufield of H.C. Wainwright & Co. asked for more detail on the mechanism and expectations for lorundrostat's benefit in obstructive sleep apnea (OSA) and any potential read-through from the ongoing hypertension trials.

    Answer

    Chief Medical Officer Dr. David Rodman explained a dual mechanism for OSA. The primary focus is treating the severe, underdiagnosed nocturnal hypertension driven by hypoxia-induced aldosterone surges, which is a direct read-through from their hypertension program. A secondary potential benefit is reducing airway obstruction itself through decreased fluid shifts and inflammation, which could be additive to standard CPAP therapy and improve outcomes.

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    Matthew Caufield's questions to Mineralys Therapeutics Inc (MLYS) leadership • Q3 2024

    Question

    Matthew Caufield from H.C. Wainwright & Co. asked if the 6-to-8 mmHg ambulatory blood pressure reduction, described as clinically meaningful during a KOL event, is the same target range for success in the Launch-HTN and Explore-CKD trials.

    Answer

    Executive Jon Congleton confirmed that this range is considered meaningful across all trials, noting that even a 1-2 mmHg reduction lowers cardiovascular risk. He reiterated that replicating the 8-10 mmHg reduction from Target-HTN would be 'truly meaningful' and transformative for the market. He affirmed this standard of success applies to Explore-CKD, which also aims to show benefits for renal function.

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    Matthew Caufield's questions to Tarsus Pharmaceuticals Inc (TARS) leadership

    Matthew Caufield's questions to Tarsus Pharmaceuticals Inc (TARS) leadership • Q2 2025

    Question

    Matthew Caufield from H.C. Wainwright & Co. asked about the role of patient overlap with related conditions (e.g., dry eye, cataracts) in driving new prescriptions for Xtendi.

    Answer

    CCO Aziz Mottiwala explained that while Demodex blepharitis (DB) is always the underlying diagnosis, physicians are increasingly screening for it in patients presenting with other conditions, which motivates new prescribers. CEO Bobak Azamian added that Tarsus plans to roll out more studies to build evidence for use in patients with comorbid conditions, further driving education and adoption.

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