RADNOR, Pa., March 24, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, announced the appointment of Jeffrey A. Munsie as Chief Legal Officer. “Jeff brings deep life sciences experience across critical stages of growth, from preclinical through commercializat ...

Core Insights - Mineralys Therapeutics, Inc. is focused on developing innovative therapies for cardiovascular and renal diseases, addressing unmet medical needs through advanced research and development efforts [1] - The company is competing within the pharmaceutical sector, aiming to bring effective treatments to market and challenge other companies in the same space [1] Financial Performance - On March 13, 2026, a price target of $30 was set for MLYS by Dennis Ding from Jefferies, indicating a potential upside of approximately 14.37% from the trading price of $26.23 at that time [2] - MLYS's Q4 2025 earnings call provided insights into its financial performance and strategic initiatives, highlighting significant developments and plans for growth [3] - Currently, MLYS is priced at $26.19, reflecting a decrease of 2.96% with a drop of $0.80, and has fluctuated between a low of $25.45 and a high of $28.65 during the day [4] - Over the past year, MLYS has experienced significant volatility, reaching a high of $47.65 and a low of $10.44 [4][6] - The company's market capitalization is approximately $1.74 billion, indicating its size and market presence [5] - Today's trading volume for MLYS on NASDAQ is 1,380,806 shares, reflecting active investor interest and engagement [5]

Core Insights - Mineralys Therapeutics Inc. (NASDAQ:MLYS) has received FDA acceptance for its New Drug Application (NDA) for lorundrostat, aimed at treating hypertension in conjunction with other medications [1][2] - The company's CEO highlighted that despite the Explore-OSA trial not demonstrating a reduction in the apnea-hypopnea index (AHI), the drug's safety profile and its effects on blood pressure are significant [1] - Bank of America raised the price target for MLYS shares from $43 to $46, maintaining a Buy rating following the company's Q3 2025 earnings report, which confirmed a cash runway until 2027 [2] Company Overview - Mineralys Therapeutics Inc. is a biotechnology firm focused on developing treatments for conditions related to aldosterone dysregulation, headquartered in Radnor, Pennsylvania [3]

Financial Data and Key Metrics Changes - The company ended 2025 with cash equivalents and investments of $656.6 million, a significant increase from $198.2 million at the end of 2024 [13] - R&D expenses for 2025 were $132 million, down from $168.6 million in 2024, with Q4 2025 R&D expenses at $24.4 million compared to $44.6 million in Q4 2024 [14][15] - G&A expenses increased to $38.6 million for 2025 from $23.8 million in 2024, with Q4 2025 G&A expenses at $13.9 million compared to $7.2 million in Q4 2024 [16] - The net loss for 2025 was $154.7 million, an improvement from $177.8 million in 2024, with Q4 2025 net loss at $32.2 million compared to $48.9 million in Q4 2024 [17] Business Line Data and Key Metrics Changes - The company is focused on the development of lorundrostat, which has shown promising results in clinical trials for treating uncontrolled and resistant hypertension [5][7] - The NDA for lorundrostat was accepted by the FDA, with a PDUFA target action date set for December 22, 2026 [5] Market Data and Key Metrics Changes - Uncontrolled and resistant hypertension affects over 20 million people in the U.S., representing a significant market opportunity for lorundrostat [8] - The company is actively engaging with payers to ensure access for lorundrostat, particularly targeting its use in third-line or later treatment [21] Company Strategy and Development Direction - The company aims to position lorundrostat as a best-in-class therapy for uncontrolled and resistant hypertension, with plans for market access and payer engagement [8][9] - There is an ongoing strategy to explore additional indications for lorundrostat, including comorbid conditions related to hypertension [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the market opportunity for lorundrostat, especially with the upcoming PDUFA date and the potential for a successful launch [20] - The company is optimistic about payer access and the value proposition of lorundrostat in treating resistant hypertension [21] Other Important Information - The company has expanded its medical communications efforts to support the launch of lorundrostat, including increased peer-reviewed publications and a larger team of medical science liaisons [9] Q&A Session Summary Question: What are the expectations from the competitive launch of lorundrostat? - Management is excited about the market opportunity and is observing competitor pricing and strategies to optimize lorundrostat's launch [20] Question: Can you provide insights on pre-launch payer interactions? - Management is optimistic about access, particularly for resistant hypertension, and believes the comprehensive dataset will support payer engagement [21] Question: How confident is the company in the results from the phase 2 OSA study? - Management acknowledged the study's limitations but emphasized the importance of demonstrating blood pressure reduction in high-risk patients [27][28] Question: What is the commercial capability being built ahead of the PDUFA date? - The company is making strategic investments in commercial capabilities and expanding its medical affairs team to ensure rapid uptake upon approval [38] Question: How does the company plan to differentiate its approach to market compared to competitors? - Management is evaluating the number of sales representatives needed and intends to leverage comprehensive clinical data to inform their commercial strategy [43][44] Question: What are the potential partnership opportunities being explored? - The company seeks partners that recognize the value of lorundrostat and can support its development beyond hypertension [93][94]

Financial Data and Key Metrics Changes - The company ended 2025 with cash equivalents and investments of $656.6 million, a significant increase from $198.2 million at the end of 2024, indicating strong liquidity to support operations into 2028 [12] - R&D expenses for 2025 were $132 million, down from $168.6 million in 2024, primarily due to a reduction in preclinical and clinical costs following the conclusion of the lorundrostat pivotal program [13][14] - G&A expenses increased to $38.6 million in 2025 from $23.8 million in 2024, driven by higher compensation and professional fees [15] - The net loss for 2025 was $154.7 million, an improvement from a net loss of $177.8 million in 2024 [16] Business Line Data and Key Metrics Changes - The company is focused on the development of lorundrostat, which has shown promising results in clinical trials for treating uncontrolled and resistant hypertension [6][10] - The NDA for lorundrostat was accepted by the FDA, with a PDUFA target action date set for December 22, 2026, marking a significant milestone for the company [5] Market Data and Key Metrics Changes - Uncontrolled and resistant hypertension affects over 20 million people in the U.S., representing a substantial market opportunity for lorundrostat [7] - The company is actively engaging with payers to ensure access for lorundrostat, particularly targeting its use in third-line or later treatment settings [20] Company Strategy and Development Direction - The company aims to position lorundrostat as a best-in-class therapy for hypertension, with plans for market access and payer engagement to support its launch [8][10] - There is an emphasis on expanding medical communications and increasing peer-reviewed publications to drive awareness and uptake of lorundrostat [8] - The company is exploring additional indications for lorundrostat, including comorbid conditions related to hypertension, such as chronic kidney disease and obstructive sleep apnea [10][66] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the market opportunity for lorundrostat, particularly in light of the unmet needs in resistant hypertension [19] - The company is optimistic about payer access and believes that the comprehensive dataset supporting lorundrostat will resonate with prescribers [20] - Management highlighted the importance of ongoing clinical development and the potential for lorundrostat to address various comorbidities associated with hypertension [10][66] Other Important Information - The company has begun planning for the commercial launch of lorundrostat, including expanding its medical affairs capabilities and preparing for potential partnerships [36][92] - The company is evaluating the potential for international submissions and partnerships to maximize the value of lorundrostat [56][92] Q&A Session Summary Question: What are the company's expectations regarding the competitive launch of lorundrostat? - Management acknowledged the competitive landscape and expressed interest in learning from competitors' pricing and market strategies while emphasizing the significant market opportunity for lorundrostat [19] Question: How confident is the company in payer access for lorundrostat? - Management expressed strong confidence in the value proposition of lorundrostat and ongoing positive dialogues with payers [20] Question: What is the company's strategy regarding commercial capabilities and potential partnerships? - Management indicated that they are building commercial capabilities while exploring partnerships, emphasizing the importance of ensuring rapid uptake upon approval [36][92] Question: How does the company plan to differentiate lorundrostat in the market? - Management discussed the comprehensive data supporting lorundrostat and the targeted approach to prescribers, focusing on specific subsegments of the hypertension market [42][43] Question: What are the company's thoughts on pricing strategy? - Management stated that it is too early to provide specifics on pricing but indicated that the value proposition resonates with payers for both third and fourth-line treatments [62] Question: What are the company's plans for exploring additional indications for lorundrostat? - Management confirmed ongoing evaluations of potential indications related to aldosterone dysregulation and the importance of addressing comorbidities associated with hypertension [66]

Financial Data and Key Metrics Changes - The company ended 2025 with cash equivalents and investments of $656.6 million, a significant increase from $198.2 million at the end of 2024 [11] - R&D expenses for 2025 were $132 million, down from $168.6 million in 2024, primarily due to a reduction in preclinical and clinical costs [12] - G&A expenses increased to $38.6 million in 2025 from $23.8 million in 2024, driven by higher compensation and professional fees [13] - The net loss for 2025 was $154.7 million, an improvement from $177.8 million in 2024 [15] Business Line Data and Key Metrics Changes - The NDA for lorundrostat was accepted by the FDA, with a PDUFA target action date set for December 22, 2026, following five positive clinical trials demonstrating its efficacy [4][5] - The company is focusing on market access planning and payer engagement to ensure the value proposition of lorundrostat is understood [6] Market Data and Key Metrics Changes - Uncontrolled and resistant hypertension affects over 20 million people in the U.S., representing a significant market opportunity for lorundrostat [6] - The company is targeting the third line or later treatment space for lorundrostat, which aligns with the needs of resistant hypertension patients [19] Company Strategy and Development Direction - The company aims to position lorundrostat as a best-in-class therapy for uncontrolled or resistant hypertension, with ongoing evaluations for further clinical development in comorbidities [9] - The strategy includes expanding medical communications and increasing peer-reviewed publications to support the launch of lorundrostat [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the market opportunity for lorundrostat, especially with the upcoming competitive launch by AstraZeneca [18] - The company remains optimistic about payer access and the value proposition of lorundrostat in the resistant hypertension space [19] Other Important Information - The company is exploring additional indications for lorundrostat, particularly in conditions driven by dysregulated aldosterone, such as chronic kidney disease and obstructive sleep apnea [64] - The company is preparing for potential partnerships to maximize the value of lorundrostat, focusing on co-development opportunities [92] Q&A Session Summary Question: What insights are expected from the competitor's launch? - Management is keen to learn about pricing strategies and market positioning from the competitor's launch, emphasizing the large market opportunity for lorundrostat [18] Question: How confident is the company in payer interactions? - Management is optimistic about access, particularly for third-line treatment, and believes the comprehensive dataset will support favorable payer discussions [19] Question: What are the implications of the phase 2 OSA study results? - Management acknowledged the study's limitations but emphasized the importance of demonstrating robust blood pressure reduction in high-risk patients [26][28] Question: What is the commercial capability being built? - The company is expanding its commercial team and medical affairs capabilities to ensure a rapid uptake of lorundrostat upon approval [36] Question: How does the company view potential partnerships? - Management seeks partners that recognize the value of lorundrostat and are willing to engage in co-development opportunities [92]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________. Commission file number 001-41614 MINERALYS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 84-1966887 (Sta ...

Mineralys Therapeutics Reports Fourth Quarter 2025 Financial Results and Provides Corporate Update – Announced FDA acceptance of NDA for lorundrostat in adults with hypertension; assigned PDUFA target date of December 22, 2026 – – Conference call today at 4:30 p.m. ET – RADNOR, PA – March 12, 2026 – Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep a ...

Core Viewpoint - Mineralys Therapeutics has made significant progress in developing lorundrostat for hypertension, with the FDA accepting its New Drug Application (NDA) and setting a target date for potential approval on December 22, 2026 [1][9]. Financial Highlights - As of December 31, 2025, the company reported cash, cash equivalents, and investments totaling $656.6 million, a substantial increase from $198.2 million in 2024 [7][26]. - Research and Development (R&D) expenses for 2025 were $132.0 million, down from $168.6 million in 2024, with Q4 2025 R&D expenses at $24.4 million compared to $44.6 million in Q4 2024 [8][10]. - General and Administrative (G&A) expenses rose to $38.6 million for 2025, up from $23.8 million in 2024, with Q4 2025 G&A expenses at $13.9 million compared to $7.2 million in Q4 2024 [11]. - The net loss for 2025 was $154.7 million, an improvement from a net loss of $177.8 million in 2024, with Q4 2025 net loss at $32.2 million compared to $48.9 million in Q4 2024 [13][24]. Clinical and Regulatory Developments - The company completed multiple clinical trials for lorundrostat, with results published in reputable journals, demonstrating its potential to significantly reduce blood pressure in patients with inadequately controlled hypertension [3][5]. - The NDA submission for lorundrostat followed five positive clinical trials, showing clinically meaningful blood pressure reduction and a favorable safety profile [9][18]. - The ongoing Transform-HTN Open-Label Extension Trial aims to gather additional long-term safety and efficacy data for lorundrostat [6]. Market Context - Hypertension is a significant health issue, contributing to over 685,000 deaths in the U.S. in 2022, with an estimated economic burden of $219 billion in 2019 [15]. - Less than 50% of hypertension patients achieve their blood pressure goals with current medications, indicating a substantial unmet need in the market [16].

Core Insights - Mineralys Therapeutics' shares increased by 4.4% following the FDA's acceptance of the new drug application (NDA) for lorundrostat, aimed at treating adult patients with hypertension in conjunction with other antihypertensive medications. A final decision from the FDA is anticipated by December 22, 2026 [1][8]. Company Developments - If approved, lorundrostat could offer a new treatment option for patients suffering from resistant and uncontrolled hypertension, based on positive data from a successful clinical program demonstrating favorable safety and blood pressure reduction [2][9]. - The NDA acceptance coincided with the release of top-line data from the phase II Explore-OSA study, which assessed lorundrostat for treating overweight or obese adults with moderate-to-severe obstructive sleep apnea (OSA) and hypertension [6][8]. - The Explore-OSA study indicated that four weeks of treatment with lorundrostat (50 mg) did not show a clinically meaningful difference in the apnea-hypopnea index (AHI) compared to placebo, the primary endpoint of the study. However, it did show a significant reduction in blood pressure and favorable safety [7][9]. Clinical Study Outcomes - Previous pivotal studies, including the phase III Launch-HTN and phase II Advance-HTN studies, demonstrated that lorundrostat met its primary efficacy endpoints with statistical significance and exhibited favorable safety and tolerability in patients with uncontrolled or resistant hypertension [10]. - Additionally, positive top-line data from the phase II Explore-CKD study indicated that lorundrostat, when added to an SGLT2 inhibitor, significantly improved outcomes in hypertensive patients with chronic kidney disease (CKD) [10]. Market Performance - Despite the recent positive news, Mineralys' shares have declined by 21.6% year-to-date, contrasting with a 6.1% increase in the industry [5]. - Currently, Mineralys has no approved products in its portfolio, making a potential FDA approval for lorundrostat a significant milestone for the company [11].