BI-689648

MLS-101 is a Highly Selective Aldosterone Synthase Inhibitor Designed to Address Abnormally Elevated Aldosterone, an Underlying Cause of Hypertension Prevalent in a Significant Portion of Patients Derek DiRocco of RA Capital Management and Olivier Litzka, PhD of Andera Partners Join Mineralys Board of Directors PHILADELPHIA, June 8, 2022 /PRNewswire/ -- Mineralys Therapeutics, Inc., a private, clinical-stage biopharmaceutical company committed to developing a best-in-class, novel therapy for the treatment of hypertension, today announced the completion of an oversubscribed and up-sized $118 million Series B financing. Mineralys plans to use the proceeds to continue to advance MLS-101, a highly selective aldosterone synthase inhibitor. MLS-101 is currently being evaluated in a Phase 2 clinical trial, called Target-HTN, for patients with uncontrolled hypertension. The Company anticipates releasing the top-line results of Target-HTN later this year. Mineralys Therapeutics, Inc. announced the completion of an oversubscribed and up-sized $118 million Series B financing Tweet this The round was led by RA Capital Management and Andera Partners. Additional new investors included RTW Investments, Rock Springs Capital, SR One Capital Management, Sectoral Asset Management, Ysios Capital, HealthCor Management and Boulder Ventures. Existing investors, including founding investment firm Catalys Pacific, Samsara BioCapital, HBM Healthcare Investments and Adams Street Partners also participated. As part of the Series B financing, Olivier Litzka, PhD, Partner, Andera Partners and Derek DiRocco, Partner, RA Capital Management will join the Mineralys Board of Directors. "MLS-101 has the potential to be a paradigm-shifting treatment by normalizing plasma aldosterone levels, selectively, without the untoward effects of blocking the mineralocorticoid receptor. This financing will allow us to further our clinical program to unlock the value of MLS-101," said Jon Congleton, Chief Executive Officer, Mineralys. "We are pleased to be joined by a strong, international group of investors who share our vision of creating a targeted approach to address the growing epidemic of abnormal aldosterone overproduction that is linked to uncontrolled hypertension and related cardiorenal disorders." "We are excited to have co-led this financing with Andera partners and look forward to helping Mineralys progress on the promise of MLS-101 for the treatment of hypertension," said Derek DiRocco, Partner, RA Capital Management. "RA Capital shares Mineralys' commitment and belief in the need to bring important new treatments to address the burden and impact of hypertension." "Hypertension remains the leading cause of heart and kidney disease, but little innovation has been made for over a decade. The work being done by Mineralys addresses an unmet need as more than half of the current patients have uncontrolled blood pressure," said Olivier Litzka, PhD, Partner, Andera Partners. "We are pleased to support Mineralys' experienced team as they work to bring a targeted treatment for the millions of hypertension patients failing to achieve their goal blood pressure." "We are delighted to have both Olivier and Derek join as new members of the Mineralys Board of Directors," said BT Slingsby MD, PhD, MPH, Founder & Executive Chairman of Mineralys. "Mineralys was created to transform the diagnosis and treatment of hypertension by targeting one its underlying causes, aldosterone, impacting millions of patients. We look forward to working with our new investors and Board members to advance the MLS-101 development program." About MLS-101 MLS-101 is a highly selective and potent aldosterone synthase inhibitor, licensed from Mitsubishi Tanabe Pharma Corporation, that is being investigated for the treatment of hypertension. MLS-101 significantly reduces plasma aldosterone levels by selectively inhibiting the CYP11B2 pathway responsible for synthesis of aldosterone, without the untoward effects of blocking the mineralocorticoid receptor. MLS-101 has demonstrated excellent selectivity for the synthesis of aldosterone without effecting other hormones like cortisol. MLS-101 selectivity holds the potential for targeted treatment of blood pressure in hypertension patients with elevated aldosterone production, an underlying cause of hypertension prevalent in at least 25 percent of all hypertensive patients. MLS-101 has been studied in healthy volunteers in a Phase 1 program that validated the aldosterone reducing effects of MLS-101 and demonstrated a safe and tolerable clinical profile. MLS-101 is currently being investigated in uncontrolled hypertension in a Phase 2, proof-of-concept study. The benefit of MLS-101 may extend beyond hypertension into end-stage renal disease, cardiac heart failure and cardiac mortality. About Mineralys Therapeutics, Inc. Headquartered in Philadelphia, PA, Mineralys Therapeutics, Inc. is a private, clinical-stage biopharmaceutical company, founded by Catalys Pacific, and is committed to developing best-in-class, novel therapy for the treatment of hypertension. The Company is driven to bring a targeted approach to the management of hypertension via the development of MLS-101. MLS-101, licensed from Mitsubishi Tanabe Pharma Corporation, is a highly selective and potent aldosterone synthase inhibitor that is being investigated for the treatment of hypertension. For more information, please visit . About RA Capital RA Capital Management is a multi-stage investment manager dedicated to company formation and evidence-based investing in healthcare and life science companies developing drugs, medical devices, diagnostics, services and research tools. The firm's portfolio of private and public companies spans the globe and most therapeutic areas across all stages from discovery through commercialization. RA is committed to fostering diversity internally, in its portfolio companies, and in the broader biotech community. For further information, please visit . About Andera Partners Created over 20 years ago, Andera Partners is a major player in private company investments in France and internationally. Its teams manage over €3.2 billion in investments in life sciences (Andera Life Sciences), growth and buyout capital (Andera MidCap, Andera Expansion, Andera Croissance, Andera Co-Invest), sponsor-less transactions (Andera Acto) and ecological transition (Andera Infra). Based in Paris, with offices in Antwerp and Munich, Andera Partners is wholly owned by its teams, which count about 90 professionals. It is structured as a partnership and managed by a board of 10 partners. Andera's 15-person life sciences team brings together extensive experience in the life sciences industry, private equity and venture capital. Active since 2000, the team has raised over €1.1 billion through its BioDiscovery family of funds and is currently investing from its new BioDiscovery 6 fund. Since inception, the team has invested in more than 75 European and U.S. biotech and medtech companies. For further information, please visit . Contact: Melyssa Weible Elixir Health Public Relations Phone: (1) 201-723-5805 Email: [email protected] SOURCE Mineralys Therapeutics

figHTN-CKD is CinCor’s fourth ongoing Phase 2 clinical trial evaluating baxdrostat (CIN-107) Initial topline data for figHTN-CKD expected in 2H 2023 WALTHAM, Mass., June 01, 2022 (GLOBE NEWSWIRE) -- CinCor Pharma, Inc. (“CinCor”) announced today that the first patient has been dosed in the Phase 2 figHTN-CKD trial evaluating baxdrostat (CIN-107), a highly selective aldosterone synthase inhibitor, in patients with uncontrolled hypertension and chronic kidney disease (CKD). “Over 37 million people in the United States suffer from chronic kidney disease and progressive loss of kidney function. While effective suppression of aldosterone can delay disease progression, long-term hypertensive treatment with current standard-of-care renin-angiotensin-aldosterone system (RAAS) agents is often associated with aldosterone breakthrough,” said Mason Freeman, M.D., Chief Medical Officer at CinCor. “Baxdrostat is a highly selective aldosterone synthase inhibitor that can significantly reduce aldosterone levels, offering the potential to not only improve uncontrolled blood pressure in CKD patients, but also ameliorate the negative impacts of aldosterone on kidney function.” Marc de Garidel, Chief Executive Officer at CinCor, added, “We are encouraged by the potential broad therapeutic utility of baxdrostat, including its unique potential to inhibit both the genomic and nongenomic effects of aldosterone. We are pleased to dose the first patient in our CKD trial, marking an important initial step in determining the value of baxdrostat in patients with impaired renal function and hypertension.” The figHTN-CKD trial is a randomized, double-blind, placebo-controlled, multicenter, parallel-group, Phase 2 clinical trial designed to assess the safety and efficacy of baxdrostat (CIN-107) in patients with uncontrolled hypertension and CKD. The trial is designed to enroll 300 patients with a glomerular filtration rate (GFR) of 25-75 ml/min and systolic blood pressure (SBP) greater than 140 mm Hg, or greater than 130 mm Hg if the patient is diabetic. The primary endpoint is the change in SBP after 26 weeks of treatment compared to placebo. Biomarkers of kidney function will also be measured to assess whether aldosterone inhibition by baxdrostat can benefit kidney function beyond the anticipated impact resulting from improved blood pressure control. Initial data for figHTN-CKD is anticipated in the second half of 2023. CKD is a condition characterized by gradual loss of renal function over time that is measured by GFR, or how much blood the kidneys filter each minute. CKD afflicts at least 15% of the U.S. adult population, or approximately 37 million people. Hypertension, diabetes and glomerulonephritis, or inflammation of the tiny filters in the kidneys, are considered leading factors contributing to the development and progression of CKD. While currently there is no cure for CKD, new therapies that can significantly reduce the progression of renal disease and delay the onset of renal failure will be critical to improving the care of CKD patients. About CinCorCinCor, founded in 2018, is a clinical-stage biopharmaceutical company with a mission to bring innovation to the pharmaceutical treatment of cardio-renal diseases. Its lead asset, baxdrostat (CIN-107), a highly selective, oral small molecule inhibitor of aldosterone synthase, is in clinical development for the treatment of hypertension and primary aldosteronism. About Baxdrostat (CIN-107)Baxdrostat (CIN-107) is a highly selective, oral small molecule inhibitor of aldosterone synthase, the enzyme responsible for the synthesis of aldosterone in the adrenal gland, in development for patient populations with significant unmet medical needs, including treatment-resistant hypertension and primary aldosteronism. Hypertension, which is defined by the American College of Cardiology and the American Heart Association as resting blood pressure above 130/80 mm Hg, is generally acknowledged to be one of the most common preventable risk factors for premature death worldwide. Though often asymptomatic, hypertension significantly increases the risk of heart disease, stroke, and kidney disease, amongst other diseases. It is estimated that as much as 20% of the global population suffers from hypertension, including nearly one-half of the adult population in the U.S., or 116 million hypertensive patients. Forward-Looking StatementsThis press release contains certain forward-looking statements, including, but not limited to, statements related to CinCor’s business in general; the results and timing of CinCor’s ongoing and planned clinical trials, including its figHTN-CKD trial; the anticipated timing of disclosure of results of clinical trials, including for figHTN-CKD; the progress of CinCor’s research and development programs and clinical trials and studies, including enrollment and retention in clinical trials; plans for initiating future clinical trials and studies; the therapeutic potential of baxdrostat (CIN-107), including its potential to be an effective treatment for patients with uncontrolled hypertension and CKD; CinCor’s clinical milestones and pipeline; expectations with respect to regulatory matters; expectations with respect to potential market size; and other statements that are not historical facts. Because such statements are subject to risks and uncertainties, actual results may differ from those expressed or implied by such forward-looking statements. Words such as “anticipates,” “believes,” “expected,” “intends,” “plan,” “may”, “will,” “project”, “estimate”, “continue,” “advance” and “future” or similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on CinCor’s current plans, objectives, estimates, expectations and intentions, involve assumptions that may never materialize or may prove to be incorrect and inherently involve significant risks and uncertainties, including factors beyond CinCor’s control, that could cause actual results, performance, or achievement to differ materially and adversely from those anticipated or implied in the statements, including, without limitation, CinCor has incurred significant operating losses since its inception; CinCor has a limited operating history and no history of commercializing products; CinCor will require substantial additional funding to finance its operations; CinCor’s business is entirely dependent at this time on the success of one drug, baxdrostat; initial, interim, “top-line” and preliminary data from clinical trials announced or published from time to time may change; CinCor may not be successful in its efforts to expand its pipeline beyond baxdrostat; success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials; enrollment and retention of patients in clinical trials could be delayed; CinCor relies and will rely on third parties to conduct, supervise and monitor existing clinical trials and potential future clinical trials; developments from the company’s competitors and the marketplace for the company’s products; and CinCor’s business, operations and clinical development timelines and plans may be adversely affected by the evolving and ongoing COVID-19 pandemic and geopolitical events, including the ongoing military conflict between Russia and Ukraine and related sanctions against Russia, and matters related thereto; and other risks and uncertainties affecting the company, including those described under the caption “Risk Factors” and elsewhere in CinCor’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission (SEC) on March 22, 2022, and other filings and reports that CinCor may file from time to time with the SEC, including its quarterly report on Form 10-Q for the three months ended March 31, 2022 filed with the SEC on May 10, 2022. Other risks and uncertainties of which CinCor is not currently aware may also affect the company’s forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. CinCor undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. Contacts:Investors:Terry CoelhoBob YedidCinCor Pharma, Inc.LifeSci AdvisorsEVP, CFO and CBDO ir@CinCor.com