– Launch-HTN, the largest trial of an aldosterone synthase inhibitor conducted among participants with uncontrolled or treatment-resistant hypertension, was one of nine studies selected as most impactful of 2025 by JAMA editors – RADNOR, Pa., Dec. 12, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA ...

Shares of Mineralys Therapeutics, Inc. (MLYS) have gained 5.1% over the past four weeks to close the last trading session at $38.91, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $49.63 indicates a potential upside of 27.6%.The average comprises eight short-term price targets ranging from a low of $42.00 to a high of $56.00, with a standard deviation of $5.78. While the lowest ...

Summary of Mineralys Therapeutics FY Conference Call Company Overview - **Company**: Mineralys Therapeutics (NasdaqGS:MLYS) - **Focus**: Development of lorundrostat, an aldosterone synthase inhibitor for treating hypertension and related conditions Key Points Clinical Development and NDA Filing - Mineralys has built a comprehensive clinical development program in 2023 and 2024, with three significant data readouts this year [2][3] - Two pivotal studies, Advance-HTN and Launch-HTN, demonstrated profound reductions in blood pressure with a safe profile, forming the basis for the NDA application [2][3] - The NDA filing is anticipated by the end of 2025 or the first quarter of 2026, including data from pivotal studies and open-label extensions [5][15] Market Opportunity - There are approximately 20 million patients in the U.S. struggling to achieve blood pressure goals, representing a significant market for lorundrostat [3][9] - The target population includes patients on two or more medications who are not reaching their goals, specifically those with resistant hypertension [9] Commercial Strategy - An estimated 400 sales representatives may be needed to effectively reach the 60,000 doctors who control 50% of the prescription market for third-line hypertension treatments [9][10] - The company has $594 million in cash, which is expected to support pre-commercialization efforts and the launch through 2027, but will not lead to profitability [11][14] Competitive Landscape - Mineralys is preparing for competition with AstraZeneca's baxdrostat, which is expected to launch around Q2 2026 [20][22] - The company is focused on building awareness and enthusiasm for lorundrostat among healthcare providers and payers, emphasizing its clinical profile and benefits [22][26] Clinical Data and Efficacy - The clinical trials have shown not only blood pressure reduction but also benefits in proteinuria, which is critical for patients with comorbid conditions [26] - The diversity of the patient population in trials is highlighted, with significant representation of Black or African-American patients, which is crucial for addressing health disparities [26][27] Future Catalysts - The next significant data readout will be from the Explore OSA trial, expected in Q1 2026, which examines the drug's effects on patients with obstructive sleep apnea [28][29] Partnership and Development - Ongoing discussions for potential partnerships are focused on enhancing the value of lorundrostat and expanding its indication profile [38][39] - The company is evaluating various scenarios for commercialization and development partnerships, which could significantly impact capital needs [14][38] Regulatory Considerations - The company has been in discussions with the FDA regarding the long-term safety profile of lorundrostat, which is critical for the NDA submission [6][8] Conclusion - Mineralys Therapeutics is positioned to launch lorundrostat in a competitive market, with a strong clinical data set and a clear strategy for commercialization and market penetration. The upcoming NDA filing and ongoing clinical trials will be pivotal in determining the company's future success.

Core Insights - Findell Capital Management has initiated a new position in Mineralys Therapeutics, acquiring 250,000 shares valued at $9.5 million, representing 3.7% of its U.S. equity portfolio as of September 30 [2][6] - Mineralys Therapeutics has seen its share price increase by 246% over the past year, significantly outperforming the S&P 500's 13% gain during the same period [3] Company Overview - Mineralys Therapeutics is a clinical-stage biotechnology company focused on developing therapies for hypertension and cardiovascular diseases, specifically through its proprietary candidate, lorundrostat [5] - The company has a market capitalization of $3.4 billion and reported a net loss of $171.4 million over the trailing twelve months [4][5] - As of the latest market close, shares of Mineralys Therapeutics were priced at $43.36 [4] Financial Performance - Mineralys ended the third quarter with no product revenue and a net loss of $36.9 million, while continuing to advance its drug candidate lorundrostat [7] - The company raised $287.5 million through a recent offering, which has expanded its cash runway and indicated rising institutional support [6] Investment Context - The investment by Findell Capital reflects a high-risk, high-reward profile typical of pre-revenue biotech companies, with a focus on clinical progress and market momentum [6][8] - The company is still in the early stages of its lifecycle, primarily utilizing capital for research and development, manufacturing, and pre-commercial planning [7][8]

Core Insights - Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension and related comorbidities, including chronic kidney disease and obstructive sleep apnea [3] Group 1: Stock Option Award - On November 24, 2025, the Compensation Committee of Mineralys granted an inducement stock option award covering 146,000 shares to a new non-executive employee [1] - The stock option will vest over a four-year period, with 25% vesting on the first anniversary and the remainder vesting monthly thereafter, contingent on continued service [2] - The award is part of the 2025 Employment Inducement Incentive Award Plan, aimed at attracting new employees [2] Group 2: Company Overview - Mineralys Therapeutics is based in Radnor, Pennsylvania, and was founded by Catalys Pacific [3] - The company's initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor [3]

Summary of Mineralys Therapeutics Conference Call Company Overview - **Company**: Mineralys Therapeutics (NasdaqGS: MLYS) - **Focus**: Development of aldosterone synthase inhibitors (ASI) targeting cardiorenal metabolic disorders, primarily hypertension [1][2] Industry Context - **Market Opportunity**: Approximately 20 million patients in the U.S. suffer from resistant and uncontrolled hypertension, with 10 million specifically identified as resistant hypertension patients [4][5] - **Competitive Landscape**: The ASI class is emerging as a new treatment option for hypertension, with recent data from competitors like AstraZeneca's Baxdrostat [2][3] Key Clinical Data - **Clinical Trials**: Successful outcomes from pivotal studies LAUNCH HTN and ADVANCE HTN, with significant blood pressure reductions observed [1][2] - **Efficacy**: Lorundrostat demonstrated a 15-19 mmHg reduction in blood pressure compared to the typical 5 mmHg improvement seen with existing treatments [5][6] - **Patient Demographics**: Strong representation of Black or African American patients in trials, addressing a high-risk population for hypertension [9][10] Drug Profile - **Selectivity**: Lorundrostat shows a selectivity ratio of 374:1 for aldosterone over cortisol, compared to Baxdrostat's 101:1, indicating a better safety profile [11][12] - **Half-Life**: Lorundrostat has a half-life of 10-12 hours, aligning with the diurnal pattern of aldosterone secretion, which may enhance safety [12][13] - **Safety Signals**: Lower incidence of hyperkalemia compared to Baxdrostat, with 8% incidence above 5.5 mEq/L for lorundrostat versus 11% for Baxdrostat [15][16] Market Strategy - **Target Population**: Initial focus on resistant hypertension, with plans to expand into uncontrolled hypertension as prescriber comfort increases [27][30] - **Commercialization Approach**: Open to partnerships but emphasizes the importance of selecting the right partner to maximize the drug's potential [45][46] - **Market Size**: Targeting a broad market of 120 million people with hypertension, with a focus on the top 60,000 prescribers [46][47] Future Developments - **NDA Filing**: Anticipated NDA filing by the end of 2025, with ongoing collection of safety and efficacy data beyond the initial 12-week trials [37][38] - **Additional Studies**: Ongoing studies in chronic kidney disease (CKD) and obstructive sleep apnea (OSA) to explore additional benefits and potential label expansions [42][43] Conclusion - **Investment Potential**: Mineralys Therapeutics is positioned with a best-in-class molecule in a growing market, with strong clinical data supporting its efficacy and safety, making it a compelling investment opportunity in the pharmaceutical sector [19][50]

Summary of Mineralys Therapeutics FY Conference Call Company Overview - **Company**: Mineralys Therapeutics (NasdaqGS:MLYS) - **Event**: FY Conference on November 11, 2025 - **Key Speaker**: Jon Congleton, CEO Industry Context - **Industry**: Hypertension treatment and drug development - **Unmet Need**: Hypertension remains a leading modifiable risk factor globally, causing approximately 10.8 million deaths annually due to related comorbidities [4][5][6] Core Points and Arguments 1. **Hypertension Treatment Landscape**: - There has been a lack of innovation in hypertension treatments over the past 20-25 years, with existing therapies not adequately addressing patient needs, particularly regarding dysregulated aldosterone [5][36] - Current treatment goals have become more stringent, with the target blood pressure now set at 130/80 mmHg for most patients and 120 mmHg for those with comorbidities [5] 2. **Lorundrostat's Mechanism and Efficacy**: - Lorundrostat is positioned as a best-in-class aldosterone synthase inhibitor (ASI) with a selectivity ratio of 374:1 for aldosterone over cortisol, which is critical for minimizing side effects [9][42] - Clinical trials (ADVANCE HTN and LAUNCH HTN) show significant blood pressure reductions of 15-19 mmHg, which are transformative compared to typical improvements of 5-6 mmHg seen with other agents [15][31] 3. **Market Opportunity**: - The potential market for lorundrostat is estimated at 20 million patients in the U.S., with 10 million classified as resistant hypertension and another 10 million as uncontrolled hypertension [36][37] - There is a strong demand for innovative treatments, with 95% of surveyed physicians indicating intent to prescribe lorundrostat if available [38] 4. **Safety Profile**: - Lorundrostat has a favorable safety profile, with lower rates of hyperkalemia compared to competitors, which may be attributed to its selectivity and pharmacokinetics [41][42] 5. **Regulatory Timeline**: - Mineralys plans to file for regulatory approval by the end of 2025 or Q1 2026, with expectations of overlapping review cycles with competitors like AstraZeneca [43] Additional Important Insights - **Patient Demographics**: The ADVANCE HTN study included a significant proportion (53%) of Black or African American patients, who are known to have more challenging hypertension profiles [28] - **Measurement Techniques**: The study utilized multiple blood pressure measurement methods, including 24-hour ambulatory monitoring, to ensure accurate assessment of treatment efficacy [16][17] - **Physician Engagement**: The company has conducted market research indicating that physicians are primarily focused on absolute blood pressure changes rather than placebo-adjusted figures, which influences prescribing behavior [31][32] This summary encapsulates the key points discussed during the conference call, highlighting the strategic positioning of Mineralys Therapeutics in the hypertension treatment landscape and the promising potential of lorundrostat as a novel therapeutic option.

Financial Data and Key Metrics Changes - The company ended Q3 2025 with cash, cash equivalents, and investments of $593.6 million, a significant increase from $198.2 million as of December 31, 2024, indicating strong liquidity to support operations into 2028 [16] - R&D expenses for Q3 2025 were $31.5 million, down from $54 million in Q3 2024, primarily due to the conclusion of the lorandirostat pivotal program [16][17] - Net loss for Q3 2025 was $36.9 million, a decrease from $56.3 million in Q3 2024, reflecting improved expense management [18] Business Line Data and Key Metrics Changes - The company is advancing its clinical programs, particularly lorandirostat, which has shown clinically meaningful reductions in systolic blood pressure across diverse patient populations [6][10] - The EXPLORE-CKD trial demonstrated a significant reduction in systolic blood pressure and a clinically meaningful reduction in urinary albumin-creatinine ratio, indicating potential renal protection [10] Market Data and Key Metrics Changes - The company is focusing on market access planning and payer engagement to ensure the value of lorandirostat is well understood, which is crucial for its commercial readiness [13] - The ongoing phase II EXPLORE-OSA trial aims to evaluate lorandirostat's efficacy in patients with obstructive sleep apnea and hypertension, with results expected in Q1 2026 [11] Company Strategy and Development Direction - The company is preparing for an NDA submission for lorandirostat, expected by the end of 2025 or early 2026, following positive pre-NDA feedback from the FDA [5][36] - The strategy includes expanding lorandirostat's profile to address comorbid conditions associated with hypertension, such as chronic kidney disease and obstructive sleep apnea [12][41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the clinical data supporting lorandirostat as a best-in-class therapy for uncontrolled and resistant hypertension [14][64] - The company is optimistic about upcoming milestones, including the NDA submission and results from the EXPLORE-OSA trial, which could enhance the drug's profile [64] Other Important Information - The company has emphasized the importance of diverse patient representation in clinical trials, particularly for Black or African American populations, which are often underrepresented in hypertension studies [54] - The management highlighted the need for partnerships to maximize the value of lorandirostat, both in the U.S. and internationally [38][49] Q&A Session Summary Question: What would the systolic blood pressure reduction be without adjusting for discontinuations? - Management indicated that they have not performed that specific analysis, as it was not part of the study plan [20][21] Question: Have you looked at the day and night blood pressure differences in the Advanced HTN trial? - Management confirmed that they are comfortable with the 24-hour control and have measured blood pressure at trough, but have yet to publish nighttime data [26][28] Question: Can you provide more details on the pre-NDA feedback? - Management stated that there were no surprises in the feedback and expressed confidence in the data set prepared for submission [35][36] Question: What are your expectations for the open label extension trial? - Management noted that the trial is progressing well, with no surprises, and results will be published once the last subject completes the study [40] Question: How do you expect to leverage data from the EXPLORE-OSA trial? - Management aims to enhance lorandirostat's profile by demonstrating its benefits beyond blood pressure reduction, addressing related comorbidities [41] Question: What differences in efficacy do you see with lorandirostat in the African American population? - Management highlighted that over 50% of participants in the Advance HTN trial were Black or African American, showing that race does not determine response to lorandirostat [54][56]

Clinical Trials and Efficacy - The pivotal trials, Launch-HTN and Advance-HTN, demonstrated statistically significant reductions in systolic blood pressure (BP) with lorundrostat, achieving a placebo-adjusted reduction of -9.1 mmHg at week 6 and -11.6 mmHg at week 12 in the Launch-HTN trial[102][103] - In the Advance-HTN trial, lorundrostat achieved a placebo-adjusted reduction of -7.9 mmHg at week 12, with a primary endpoint p-value of 0.001[107] - The Phase 2 Explore-CKD trial showed highly statistically significant results for lorundrostat in treating hypertension in patients with chronic kidney disease (CKD)[98] - The FDA cleared the investigational new drug application for the Explore-OSA trial, evaluating lorundrostat in patients with obstructive sleep apnea (OSA) and hypertension[101] - The Explore-CKD trial showed a placebo-adjusted change in systolic BP of -7.5 mmHg (p=0.0024) and a -25.60% change in UACR (p=0.0015) with lorundrostat 25 mg[112] Patient Demographics and Safety - Key characteristics of participants in the Launch-HTN trial included approximately 63% having a BMI ≥ 30 kg/m² and 29% being Black or African American[104] - The Advance-HTN trial enrolled participants who were on a standardized regimen of antihypertensive medications, reflecting a high-risk population[106] - Clinical safety findings from the pivotal trials support a favorable benefit-risk profile for lorundrostat, including monitoring of serum potassium and estimated glomerular filtration rate (eGFR)[108] - In the Launch-HTN trial, the incidence of treatment-emergent serious adverse events (SAEs) was 2.2% in the 50 mg arm and 0.7% in the 50 to 100 mg arm, compared to 3.0% in the placebo arm[109] - In the Advance-HTN trial, the incidence of treatment-emergent SAEs was 6.4% in the lorundrostat 50 mg arm and 8.4% in the 50 to 100 mg arm, compared to 2.1% in the placebo arm[110] Financial Overview - As of September 30, 2025, the company had cash, cash equivalents, and investments totaling $593.6 million[118] - The company raised approximately $1.0 billion in gross proceeds since inception, with net proceeds of approximately $269.6 million from a stock sale in September 2025[118] - The net losses for the nine months ended September 30, 2025, and 2024 were $122.4 million and $128.9 million, respectively, with an accumulated deficit of $424.9 million as of September 30, 2025[119] - The company expects expenses and operating losses to increase substantially as it conducts ongoing clinical trials and seeks regulatory approval for lorundrostat[119] - The company has no products approved for sale and does not expect to generate revenue until lorundrostat is developed and approved[121] Ongoing Trials and Future Plans - The ongoing Transform-HTN extension trial is evaluating the long-term efficacy, safety, and tolerability of lorundrostat, with topline results from the Explore-OSA trial anticipated in Q1 2026[117] - The company is exploring the application of lorundrostat for other indications related to dysregulated aldosterone biology, including OSA[100] Expenses and Cash Flow - For the three months ended September 30, 2025, research and development expenses decreased by $22.5 million to $31.45 million compared to $53.99 million in the same period of 2024[138] - General and administrative expenses increased by $3.6 million for the three months ended September 30, 2025, totaling $9.68 million compared to $6.12 million in 2024[141] - The net loss for the three months ended September 30, 2025, was $36.93 million, a decrease of $19.41 million from a net loss of $56.34 million in the same period of 2024[138] - Research and development expenses for the nine months ended September 30, 2025, decreased by $16.4 million to $107.61 million compared to $124.01 million in 2024[143] - General and administrative expenses for the nine months ended September 30, 2025, increased by $8.1 million to $24.72 million compared to $16.62 million in 2024[145] Cash Flow Activities - Net cash used in operating activities was $104.5 million for the nine months ended September 30, 2025, compared to $99.5 million for the same period in 2024, reflecting an increase of $5.1 million[155] - Net cash used in investing activities was $286.3 million for the nine months ended September 30, 2025, compared to net cash provided of $31.4 million in 2024, driven by a $236.7 million increase in purchases of marketable securities[156] - Net cash provided by financing activities was $494.3 million for the nine months ended September 30, 2025, significantly higher than $116.1 million in 2024, with $270.2 million from a public offering in September 2025[157] Market Risks and Economic Factors - The company is exposed to market risks related to interest rate changes, but a hypothetical 10% change in interest rates would not have a material effect on operations[167] - The company is also exposed to foreign currency exchange risks due to contracts with vendors outside the U.S., but fluctuations have not been significant to date[168] - Inflation has increased costs related to labor and research and development, which may impact future financial conditions and results of operations[169] - Operating activities cash flow was affected by increased clinical trial expenses and personnel costs, with a $19.8 million change in working capital[155] - The company has not had a formal hedging program for foreign currency, and believes that exchange rate fluctuations have not significantly impacted operations[168]

Financial Performance - Cash, cash equivalents, and investments increased to $593.6 million as of September 30, 2025, up from $198.2 million as of December 31, 2024[4] - The net loss for Q3 2025 was $36.9 million, a reduction from $56.3 million in Q3 2024[8] - Total other income, net for Q3 2025 was $4.2 million, compared to $3.8 million in Q3 2024, attributed to increased interest earned on investments[7] Research and Development - Research and Development (R&D) expenses decreased to $31.5 million for Q3 2025, down from $54.0 million in Q3 2024, primarily due to the conclusion of the lorundrostat pivotal program[5] - The company has completed four successful clinical trials of lorundrostat, supporting its efficacy and safety profile[17] - The company completed enrollment in the Explore-OSA Phase 2 trial, with topline results expected in Q1 2026[3] Future Plans - The company plans to submit a New Drug Application (NDA) for lorundrostat by late 2025 or Q1 2026[1] - The company believes its current cash reserves will fund planned clinical trials and operations into 2028[4] - The company aims to evaluate lorundrostat's use in hypertension-related comorbidities, expanding its treatment opportunities[3] Administrative Expenses - General and Administrative (G&A) expenses rose to $9.7 million in Q3 2025, compared to $6.1 million in Q3 2024, driven by higher compensation and professional fees[6]