Mineralys Therapeutics, Inc. (MLYS) Earnings

Management highlights

### Clinical Development and Clinical Evidence - Added new Chief Medical Officer Dr. Terry Ferguson (former cardiovascular therapeutic area head at Amgen), with former CMO Dr. David Rodman staying on as a full-time strategic advisor. - Presented post-hoc analysis of lorondrastat from the Pivotal Launch-HTN trial at the European Society of Hypertension 2026 annual meeting: CKD patients experienced meaningful blood pressure reductions matching the broader trial population, and patients with baseline albuminuria achieved a 52% placebo-adjusted reduction in urine albumin to creatinine ratio (a key kidney injury marker). - Presented exploratory late-breaking proteomic data at the Endocrine Society 2026 annual meeting demonstrating lorondrastat is associated with significant reductions in multiple heart failure risk biomarkers, strengthening the biological rationale for potential benefits beyond hypertension. - The Transform-HTN open-label extension trial continues to generate long-term safety and efficacy data supporting lorondrastat's potential best-in-class profile. ### Corporate and Financing Updates - Completed an agreement to repurchase future royalty payments to Tanabe Pharma for lorondrastat, for a $200 million upfront payment and up to $100 million in additional commercial milestones, for a total potential aggregate payment of up to $265 million. - Completed a $150 million equity offering and secured a $500 million committed senior secured term loan facility with Pharmacon Advisors, providing sufficient capital to fund operations through a potential launch into 2028 and enhance long-term asset value. ### Commercial Launch Preparedness - Market research confirms strong unmet need for new therapies for 20 million US adults with uncontrolled/resistant hypertension, and lorondrastat's clinical profile aligns with physician and payer needs. - Core commercial infrastructure is already in place, with efforts now focused on final launch readiness: - Established relationships with leading hypertension KOLs to support clinical practice adoption post-approval. - Completed initial payer engagement with payers covering the vast majority of US covered lives; conversations confirm payers recognize the unmet need in this patient population. - Development of a differentiated provider and patient education launch campaign is well underway, with completed research to optimize messaging and adoption. - Experienced sales leadership is in place, geographic mapping of high-prescription regions is complete, and the full sales organization will be fully staffed ahead of the December PDUFA date.

Guidance

- The company confirms the lorondrastat PDUFA date with the FDA is December 22, 2026, and remains on track to complete all pre-launch activities ahead of this date. - Management expects the full sales organization to be fully staffed and in position ahead of the PDUFA date, enabling immediate launch execution if approved. - Current cash, cash equivalents, and investments are sufficient to fund all planned operations, including a potential commercial launch of lorondrastat, into 2028. - Label negotiation discussions with the FDA are expected to begin in the October-November 2026 timeframe, two months ahead of PDUFA, in line with standard timelines. - The company will not announce the final pricing of lorondrastet until after approval, close to the potential launch date. - Management expects progressive increases in payer coverage through 2027, with commercial coverage expanding faster than Medicare coverage; Medicare coverage will be supported by medical exceptions with a high historical approval rate and a dedicated field reimbursement team. - A hypertension guideline update that would include the new aldosterone synthase inhibitor (ASI) class is expected in 2027. - The company continues to evaluate further clinical development opportunities for lorondrastat in additional indications including chronic kidney disease and heart failure, and will announce future development plans when aligned.

Segment performance

Mineralis Therapeutics is a clinical-stage biotech focused on a single lead product candidate, lorondrastat, for the treatment of uncontrolled/resistant hypertension. No additional product segments are reported. For the quarter ended June 30, 2026: - R&D expenses: $221.4 million (vs. $38.3 million in Q2 2025) - G&A expenses: $24.7 million (vs. $8.5 million in Q2 2025) - Net other income: $5 million (vs. $3.5 million in Q2 2025) - Net loss: $241.1 million (vs. $43.3 million in Q2 2025) - Cash, cash equivalents, and investments as of June 30, 2026: $661.4 million (vs. $656.6 million as of December 31, 2025)

Risks & headwinds

- Forward-looking statements (including launch plans, clinical benefit, and regulatory outcomes) are subject to inherent uncertainties, and actual results may differ materially from expectations, per standard SEC disclosures. - There is competition for cardiovascular sales talent from concurrent launches of competing products, which could impact hiring timelines. - Missing the initial Medicare Part D formulary cycle could slow initial Medicare access in 2027, requiring a gradual access build over the year. - Final label content and indication are still subject to FDA negotiation, and desired differentiated labeling claims are not guaranteed. - Partnering discussions for global commercialization are ongoing, and no partnership has been finalized to date. - Outcomes of future clinical development in additional indications are uncertain and have not yet been planned or finalized.

Analyst Q&A

• Q: How is the company navigating competition for cardiovascular sales talent from competing launches, what candidate attributes are prioritized, and will the full team be hired ahead of the December PDUFA? /

  A: Management reports the quality of candidates for all sales roles has been very strong. Mineralis’s innovative, high-impact mission attracts top talent, and the company prioritizes both relevant cardiovascular experience and alignment with company values. Management confirms they remain on track to have the full sales team fully in place ahead of the PDUFA date.

• Q: How will the company differentiate its labeling and clinical profile for lorondrastat from the already launched competing ASI baxdrostat, and can it secure labeling for resistant hypertension and CKD use? /

  A: Management expects the core indication to be similar to baxdrostat (for inadequately controlled hypertension on background therapy). Differentiation will come from inclusion of the company's unique ADVANCE-HTN trial data (which confirms efficacy in confirmed resistant hypertension after optimized background treatment) and Explore CKD trial data (which supports use down to an EGFR of 30, compared to 45 for baxdrostat). The company's trial data also demonstrates larger systolic blood pressure reductions and a more favorable hyperkalemia safety profile, which will be highlighted in labeling discussions.

• Q: As a second-to-market ASI, will the company price lorondrastat at a discount to gain market share, following baxdrostat's published price? /

  A: Management confirms baxdrostat's price point is consistent with the company's prior expectations and payer research. The company is in the final stages of setting its own price, but its core strategy is to maximize long-term value rather than starting a downward pricing spiral; no discounting strategy has been confirmed.

• Q: What are the near-term priorities for new CMO Terry Ferguson, and what is the outlook for future CKD development for lorondrastat? /

  A: Terry Ferguson will lead medical affairs and late-stage activities ahead of launch, building on the work of former CMO David Rodman, who remains as a full-time strategic advisor leading translational research into new indications. Robust existing data already shows lorondrastat delivers meaningful kidney-protective biomarker reductions; management is currently evaluating next steps for formal CKD clinical development, and will announce plans once finalized.