The Latest Cardiac and Vascular News
PRINCETON, N.J., May 14, 2025 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, today reported financial results for the first quarter ended March 31,…
Resolution of CRL Manufacturing issues in progress – Type A meeting requested No clinical safety or efficacy concerns raised by FDA MONTREAL and CHARLOTTE, N.C., May 14, 2025 (GLOBE NEWSWIRE) — Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the first quarter ended March 31, 2025. The Company also announced the submission of a meeting request to the U.S. Food and Drug Administration (FDA) as the next step in the resolution of CRL issues. “Our immediate priority is to engage with the U.S. FDA in order to address the CMC-related issues raised in the CRL received for CARDAMYST as a treatment for PSVT,” said Joe Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “We are confident we can work with the FDA to fully respond to the CRL and remain committed to the potential of CARDAMYST. If approved, it will be the first and only self-administered therapy for the rapid termination of episodes of PSVT.” First Quarter and Recent Program Updates Etripamil for Patients with PSVT CRL for CARDAMYST™ for PSVT received from FDA. In March 2025, Milestone received a CRL regarding its NDA for CARDAMYST, its lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT). In the letter, the Agency highlighted two key Chemistry, Manufacturing and Controls (CMC) issues to be addressed: 1) additional information on nitrosamine impurities was requested, based on new draft guidance that was issued during the review of the NDA , and 2) a new inspection of a facility listed in the NDA is required, to ensure it is in compliance with current Good Manufacturing Practices (GMP). The facility, which previously performed a portion of the testing required to release etripamil final product, changed ownership during the review of the NDA. Milestone is prepared to discuss the issues raised in the CRL during the Type A meeting with the FDA.Patent Issued by the U.S. Patent and Trademark Office (USPTO) on a new Method of Use patent for etripamil nasal spray. The new patent (U.S. Patent No. 12,257,224) covers the repeat dose regimen that was used in the RAPID Phase 3 study that evaluated etripamil in PSVT and is included in the proposed package insert for CARDAMYST. The issued patent potentially extends the intellectual property protection for CARDAMYST in the United States until July 2042, which would be an additional six years of protection for the company’s intellectual property portfolio.CARDAMYST highlighted in independent Survey of Managed Care professionals. Results from an independent survey conducted by Managed Healthcare Executive and The American Journal of Managed Care were published on May 6, 2025. CARDAMYST was selected by 40% of respondents (which included payers, providers and academics) when asked which new drug is expected to make the biggest difference in patient health. A copy of the article can be accessed here.Commercial Launch Plan investor event held in February. The event, held on February 25, 2025 in New York City, provided an in-depth overview of the Company’s commercial strategy for CARDAMYST nasal spray, if approved. A replay of the event, as well as a copy of the slides, can be found on the corporate website here.Poster on etripamil presented at American College of Cardiology Annual Meeting (ACC.25). The poster titled, “Consistency and Predictiveness of Conversion Among Multiple Episodes of Paroxysmal Supraventricular Tachycardia (PSVT) treated with Etripamil: Outcomes from the NODE-303 trial,” was presented at the meeting on March 30, 2025 by James Ip, M.D., Professor, Division of Cardiology, Weill Cornell Medicine, New York Presbyterian Hospital. A copy of the poster can be accessed here. Etripamil for patients with atrial fibrillation with rapid ventricular rate (AFib-RVR) Phase 3 protocol in AFib-RVR finalized Milestone has finalized the Phase 3 study protocol following FDA’s review and obtained concurrence with the Agency to proceed. The Company is pausing initiation of enrollment of the study due to prioritizing resources to resolve the CRL received on the NDA for etripamil in PSVT. First Quarter 2025 Financial Results As of March 31, 2025, Milestone had cash, cash equivalents, and short-term investments of $56.0 million, compared to $69.7 million as of December 31, 2024.There was no revenue for the first quarter ended March 31, 2025 or for the first quarter of 2024.Research and development expense for the first quarter of 2025 was $5.0 million, compared with $3.6 million for the prior year period. The increase was primarily due to higher consulting costs in drug manufacturing and regulatory costs.General and administrative expense for the first quarter of 2025 was $5.2 million, compared with $4.0 million for the prior year period. This increase was driven primarily by an increase in outside service costs, partially offset by a decrease in personnel costs.Commercial expense for the first quarter of 2025 was $10.4 million, compared with $2.9 million for the prior year period. This increase is a result of additional personnel costs, professional costs and other operational expenses related to preparation for the launch of CARDAMYST. As a result of the CRL, Milestone has temporarily paused the ramping of operational expenditures related to launch, but will maintain the capability to launch quickly, pending approval of CARDAMYST by the FDA.For the first quarter of 2025, net loss was $20.8 million, compared to $10.4 million for the prior year period. For further details on the Company’s financials, refer to the Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC. About EtripamilEtripamil is Milestone’s lead investigational product. It is a novel calcium channel blocker nasal spray under clinical development for frequent and often highly symptomatic episodes of PSVT and AFib-RVR. It is designed as a self-administered rapid response therapy for patients thereby bypassing the need for immediate medical oversight. If approved, etripamil is intended to provide health care providers with a new treatment option to enable on-demand care and patient self-management. This portable, self-administered treatment may provide patients with active management and a greater sense of control over their condition. CARDAMYST™, the conditionally approved brand name for etripamil nasal spray, is well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT and Phase 2 trial for the treatment of patients with AFib-RVR. About Milestone PharmaceuticalsMilestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular solutions to improve the lives of people living with complex and life-altering heart conditions. The Company’s focus on understanding unmet patient needs and improving the patient experience has led us to develop new treatment approaches that provide patients with an active role in self-managing their care. Milestone’s lead investigational product is etripamil, a novel calcium channel blocker nasal spray that is being studied for patients to self-administer without medical supervision to treat symptomatic episodic attacks associated with PSVT and AFib-RVR. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “continue,” “could,” “demonstrate,” “designed,” “develop,” “estimate,” “expect,” “may,” “pending,” “plan,” “potential,” “progress,” “will”, “intend” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Milestone’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding: the outcomes of future interactions with the FDA, including the potential Type A meeting; Milestone’s ability to address the issues raised in the CRL on a timely basis, if at all; the outcome of the potential NDA resubmission; CARDAMYST’s potential as a novel treatment option to help patients with PSVT; potential protections afforded by U.S. patents; CARDAMYST’s ability to make the biggest difference in patient health, as compared to other available treatment options; the timing of patient enrollment in the Phase 3 study of etripamil for AFib-RVR; and other statements not related to historical facts. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, whether our future interactions with the FDA will have satisfactory outcomes; whether and when, if at all, our NDA for etripamil will be approved by the FDA; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of our clinical trials; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data; and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, general economic, political, and market conditions, including deteriorating market conditions due to investor concerns regarding inflation, international tariffs, Russian hostilities in Ukraine and ongoing disputes in Israel and Gaza and overall fluctuations in the financial markets in the United States and abroad, risks related to pandemics and public health emergencies, and risks related the sufficiency of Milestone’s capital resources and its ability to raise additional capital in the current economic climate. These and other risks are set forth in Milestone’s filings with the U.S. Securities and Exchange Commission (SEC), including in its annual report on Form 10-K for the year ended December 31, 2025 and its quarterly report on Form 10-Q for the quarter ended March 31, 2025, in each case under the caption “Risk Factors,” as such discussions may be updated from time to time by subsequent filings Milestone may make with the SEC. Except as required by law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. Contact: Kim Fox, Vice President, Communications, kfox@milestonepharma.com Investor Relations Kevin Gardner, kgardner@lifesciadvisors.com Milestone Pharmaceuticals Inc.Condensed Consolidated Balance Sheets (Unaudited)(in thousands of US dollars, except share data) March 31, 2025 December 31, 2024Assets Current assets Cash and cash equivalents $45,085 $25,314 Short-term investments 10,873 44,381 Research and development tax credits receivable 994 901 Prepaid expenses 2,356 1,840 Other receivables 1,167 1,490 Total current assets 60,475 73,926 Operating lease right-of-use assets 1,234 1,376 Property and equipment 176 197 Total assets $61,885 $75,499 Liabilities, and Shareholders’ (Deficit) Equity Current liabilities Accounts payable and accrued liabilities $12,421 $7,555 Operating lease liabilities 542 571 Total current liabilities 12,963 8,126 Operating lease liabilities, net of current portion 758 874 Senior secured convertible notes 54,287 53,352 Total liabilities 68,008 62,352 Shareholders’ (Deficit) Equity Common shares, no par value, unlimited shares authorized, 53,464,273 shares issued and outstanding as of March 31, 2025, 53,353,984 shares issued and outstanding as of December 31, 2024 288,188 288,048 Pre-funded warrants – 12,910,590 issued and outstanding as of March 31, 2025 and 12,910,590 as of December 31, 2024 53,076 53,076 Additional paid-in capital 40,919 39,568 Accumulated deficit (388,306) (367,545) Total shareholders’ (deficit) equity (6,123) 13,147 Total liabilities and shareholders’ equity $61,885 $75,499 Milestone Pharmaceuticals Inc.Condensed Consolidated Statements of Loss (Unaudited)(in thousands of US dollars, except share and per share data) Three months ended March 31, 2025 2024 Revenue $— $— Operating expenses Research and development, net of tax credits 4,978 3,639 General and administrative 5,167 3,953 Commercial 10,378 2,884 Loss from operations (20,523) (10,476) Interest income 697 994 Interest expense (935) (872) Net loss and comprehensive loss $(20,761) $(10,354) Weighted average number of shares and pre-funded warrants outstanding, basic and diluted 66,285,406 50,155,111 Net loss per share, basic and diluted $(0.31) $(0.21)
MINNEAPOLIS and BRISBANE, Australia, May 13, 2025 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today reported financial results for the quarter ended March 31, 2025, and provided a corporate update. First Quarter 2025 Highlights Investigational Device Exemption (“IDE”) for the DurAVR® THV’s global, pivotal clinical trial (the “PARADIGM Trial”), submitted to the FDA during the First QuarterScale up for commencement of the PARADIGM Trial ongoing – including expanding the Clinical Specialist Team and contracting with planned centers in the U.S., Canada and EuropeClinical milestone of 100 patients successfully treated with the DurAVR® THV – comprised of de novo aortic stenosis cases including complex anatomies, and valve-in-valve patientsReported one-year clinical data for DurAVR® THV – demonstrating sustained, favourable hemodynamic outcomes, a consistent safety profile and high implant successOngoing expansion of global manufacturing capacity to scale for the PARADIGM Trial and meet initial anticipated commercial demandAnteris included in the FTSE Russell 2000® IndexConcluded the First Quarter with a cash position of $49.0m (A$78.0m) “Our focus this quarter has been on completing the substantial technical, clinical and regulatory work required to lodge our IDE application, which was successfully submitted during the period. We are also proud to have reached a major clinical milestone with over 100 patients treated with DurAVR®, the first new class of product in this space for many years – an incredible achievement which reflects the strength of our clinical program and growing physician confidence in our technology. Finally we continue to scale our field based Clinical Team, Manufacturing and Quality organizations to ensure we are able to meet the demands of the PARADIGM Trial” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris. Business & Operations DurAVR® THV Commercialisation Update Preparations for the PARADIGM Trial The proposed DurAVR® THV global pivotal registration trial has been formally designated as the PARADIGM Trial, signifying the trial’s central role in the DurAVR® THV Clinical Development Program. PARADIGM: A Prospective rAndomized tRial Assessing the safety and effectiveness of the DurAVR bIomimetic valve designed for physioloGic flow compared to CoMmercial TAVR devices An IDE application for the PARADIGM Trial was submitted to the U.S. Food and Drug Administration (FDA) during the First Quarter. An approved IDE allows the investigational device (the DurAVR® THV) to be used in a clinical study to collect safety and effectiveness data. The PARADIGM Trial is designed to provide the robust clinical evidence required to support an application to the FDA for Premarket Approval (“PMA”*) in the United States, with CE Mark approval anticipated to progress in parallel to the PMA. The Company remains on track to commence the PARADIGM Trial in the third quarter of 2025, pending FDA approval of the IDE. The naming of the PARADIGM Trial reflects both the paradigm-shifting hemodynamic performance observed to date in over 110 patients treated with the DurAVR® THV and the trial’s head-to-head, comparative design. It is proposed that patients will be randomized 1:1 to either the DurAVR® treatment arm or to a commercially available device in the control arm (SAPIEN or Evolut series THV). Patients with an existing failed surgical valve, needing valve-in-valve (“ViV”) TAVR are proposed to be enrolled in a separate parallel registry. This is intended to support the Company’s plans for the ViV market opportunity. Scale up activities for the PARADIGM Trial The Company continues to develop infrastructure to support the PARADIGM Trial including building out the global Clinical Specialist Team to provide on-site expert clinical support in addition to working with its Contract Research Organisation to engage with planned centers and investigators in the U.S., Canada and Europe. These teams will provide oversight and guidance to site based clinical staff to ensure appropriate use of the DurAVR® THV System, high-quality data collection and adherence to regulatory and protocol requirements throughout the PARADIGM Trial. These preparatory steps are intended to increase the speed of enrolment following IDE approval. Clinical Milestone – 100 patients successfully treated with the DurAVR® THV During the First Quarter, Anteris achieved a major clinical milestone when the 100th patient was successfully treated with the DurAVR® THV System. This marks a significant achievement for Anteris and its goal to restore heart valve patients to healthy function. The patients included de novo (first time) aortic stenosis cases, some with complex anatomies such as bicuspid aortic valve patients. Additionally, a cohort of ViV patients were treated—these are patients who underwent a previous surgical or transcatheter aortic valve replacement procedure (SAVR or TAVR) and subsequently experienced failure of their bioprosthetic aortic valve. At the end of the First Quarter, 65 of the 100 patients treated with the DurAVR® THV, had successfully completed the primary endpoint measures of safety and efficacy including hemodynamic benefit at 30-days post implant. These results are both clinically relevant and significantly differentiated to current therapies available to aortic stenosis patients. Clinical Data – One-year patient outcomes for DurAVR® THV patients Anteris released one-year clinical data for patients treated with the DurAVR® THV, as a late breaking clinical trial podium presentation by Rishi Puri, M.D. PhD, at the Sydney Valves structural heart conference in March 2025. The one-year data, which was included in the IDE submission to the FDA, demonstrated a consistent safety and efficacy profile, with high implant success across the clinical program. Highlights from the one-year data include: Favorable hemodynamics sustained to one-year: DurAVR® THV demonstrated an Effective Orifice Area (EOA) of 2.1 + 0.2 cm2, a Mean Pressure Gradient (MPG) of 8.6 + 2.6 mmHg and Doppler Velocity Index (DVI) of 0.58.Strong safety profile at one year: No valve or cardiovascular related mortality. Importantly, there was no prosthesis-patient mismatch (PPM) reported in small annuli patients with aortic annulus area of 395.80 + 37.26 mm2, while current commercial devices have rates between 11.2% to 35.3% PPM1, a predictor of valve failure and disease progression. The clinical presentation is available on the Company’s website. Expansion of global manufacturing capacity During the First Quarter, the Anteris team continued to expand global manufacturing capacity to scale for the PARADIGM Trial. All production (DurAVR® THV, ComASUR® Delivery System, crimper, E-sheath) are being scaled into new ISO Qualified Clean Room facilities, increasing manufacturing capacity to at least three times the 2024 capacity levels. The transition to the new facilities aims for a reliable and scaled inventory supply to support the anticipated commencement of the PARADIGM Trial. In addition, the gold-standard ADAPT® tissue for the DurAVR® THV will be sourced from both the U.S. and Australia moving forward to mitigate supply chain risks. This progress reflects the strategic deployment of capital into infrastructure that supports operational readiness and long-term growth capacity for clinical and commercial success. First Quarter 2025 Financial Results The financial results for Anteris for the quarter ended March 31, 2025 compared to March 31, 2024 are reviewed below. All amounts in $ refer to US dollars. Net sales during the three months ended March 31, 2025 were $0.6 million, a decrease of $0.2 million (27%), compared to $0.8 million for the same period in the prior year, primarily due to lower demand for tissue products in 2025. Loss after Income Tax was $21.9 million for the three months ended March 31, 2025, an increase of $5.8 million (36%) compared to $16.2 million for the same period in the prior year. R&D expenses during the three months ended March 31, 2025 were $16.5 million, an increase of $4.9 million (42%) compared to $11.6 million for the same period in the prior year. This is primarily due to $3.5 million relating to the upscaling of manufacturing capabilities including process design and validation activities and the expansion of headcount and $1.5 million relating to preparatory activities linked to the PARADIGM Trial, including clinical costs associated with the enrollment of additional patients;Selling, general and administrative expenses during the three months ended March 31, 2025 were $5.7 million, a decrease of $0.8 million (13%) compared to $6.5 million for the same period in the prior year, primarily due to a reduction of $1.2 million relating to costs incurred in the first quarter of 2024 associated with the plans to re-domicile, list on Nasdaq and conduct our initial public offering, partly offset by a $0.8 million increase in legal, tax and compliance costs linked to dual listing requirements and other operational matters. There was also a decline in share based payment expense of $0.5 million. Anteris refers to the detailed Financial Information contained in its Form 10-Q filing, including the Management Discussion & Analysis and the risks described therein. Corporate and Financing Activities In January 2025, TD Cowen, Barclays and Cantor, the Underwriters to the December 2024 US IPO, partially exercised the green shoe option granted by Anteris. This green shoe option was in respect of 78,481 shares of Common Stock at the purchase price of US$6.00 per share, less underwriting discounts and commissions, to raise a further $0.47 million. During the First Quarter, Anteris was included as one of seven IPO additions to the FTSE Russell 2000® Index, effective as of March 24, 2025. The FTSE Russell 2000® Index measures the performance of the small-cap segment of the US equity market. The FTSE Russell® 2000 Index is a subset of the Russell 3000® Index which is designed to represent approximately 98% of the investable US equity market. 1 Herrmann HC, Mehran R, Blackman DJ, Bailey S, Möllmann H, Abdel-Wahab M, Ben Ali W, Mahoney PD, Ruge H, Wood DA, Bleiziffer S, Ramlawi B, Gada H, Petronio AS, Resor CD, Merhi W, Garcia Del Blanco B, Attizzani GF, Batchelor WB, Gillam LD, Guerrero M, Rogers T, Rovin JD, Szerlip M, Whisenant B, Deeb GM, Grubb KJ, Padang R, Fan MT, Althouse AD, Tchétché D; SMART Trial Investigators. Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus. N Engl J Med. 2024 Jun 6;390(21):1959-1971. doi: 10.1056/NEJMoa2312573. Epub 2024 Apr 7. PMID: 38587261. *A Premarket Approval (PMA) application requires a high level of clinical evidence to demonstrate reasonable assurance of safety and effectiveness for the intended use. Randomized controlled trials are generally considered Level 1 evidence, the highest level for determining the effectiveness of interventions in evidence-based medicine given RCTs mimimize bias and allow a clear comparison between treatment groups. About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris’ lead product, the DurAVR® Transcatheter Heart Valve (THV), was designed in partnership with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System. Forward-Looking Statements This announcement contains forward-looking statements. Forward-looking statements include all statements that are not historical facts, including the objectives of and plans for Anteris’ studies and trials, the timing of the PARADIGM Trial, the goals of the expansion of the global manufacturing capacity and the sourcing of ADAPT® tissue for the DurAVR® THV in the future. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2024 that was filed with the Securities and Exchange Commission and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations. Authorisation and Additional information This announcement was authorised for release by the Board of Directors. For more information: Investor RelationsInvestor Relations (US)investors@anteristech.commchatterjee@bplifescience.comDebbie OrmsbyMalini Chatterjee, Ph.D.Anteris Technologies Global Corp.Blueprint Life Science Group+61 1300 550 310 | +61 7 3152 3200+1 917 330 4269 Websitewww.anteristech.com X@AnterisTech LinkedInhttps://www.linkedin.com/company/anteristech
Entrepreneur Of The Year celebrates ambitious entrepreneurs who are shaping the future KIRKLAND, Wash., May 13, 2025 (GLOBE NEWSWIRE) — Ernst & Young LLP (EY US) announced the finalists for the Entrepreneur Of The Year 2025 Mountain West Award. Now in its 40th year, the Entrepreneur Of The Year program celebrates the bold leaders who disrupt markets through the world’s most ground-breaking companies, revolutionizing industries and making a profound impact on communities. The Mountain West program celebrates entrepreneurs from Alaska, Colorado, Idaho, Montana, Oregon, Utah, Washington, and Wyoming. An independent panel of judges selected Brian Webster, President and Chief Executive Officer of Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), among 41 finalists for their entrepreneurial spirit, purpose, growth, and lasting impact in building long-term value. “Being named a finalist for the Entrepreneur Of The Year® 2025 Mountain West Award is a meaningful acknowledgment of the work we’re doing at Kestra,” said Brian Webster. “Our goal has always been to challenge the status quo in cardiac care by developing innovative, inclusive solutions that address real patient needs. This recognition underscores our commitment to transforming healthcare through purposeful innovation and building a company culture that values diversity and impact.” Founded in 2014, Kestra Medical Technologies is a commercial-stage wearable medical device company focused on transforming outcomes in cardiovascular care through intuitive, intelligent, and connected technologies. Its flagship product, the ASSURE® Wearable Cardioverter Defibrillator, delivers life-saving defibrillation therapy through a design centered on patient comfort, connectivity, and recovery support. Entrepreneur Of The Year honors business leaders for their ingenuity, courage, and entrepreneurial spirit. The program celebrates original founders who bootstrapped their business from inception or who raised outside capital to grow their company; transformational CEOs who infused innovation into an existing organization to catapult its trajectory; and multigenerational family business leaders who reimagined a legacy business model to strengthen it for the future. Regional award winners will be announced on June 20 during a special celebration in Salt Lake City, Utah, and will become lifetime members of an esteemed community of Entrepreneur Of The Year alumni from around the world. The winners will then be considered by the National judges for the Entrepreneur Of The Year National Awards, which will be presented in November at the annual Strategic Growth Forum®. SponsorsFounded and produced by Ernst & Young LLP, the Entrepreneur Of The Year Awards include presenting sponsors PNC Bank, Cresa, LLC, Marsh USA, and SAP. In the Mountain West region, sponsors also include regional Gold sponsors, Perkins Coie, Strong & Hanni Law Firm and Truss and regional Silver sponsors, Big Picture, Pierpont Communications, and Silicon Slopes. About Entrepreneur Of The Year Founded in 1986, Entrepreneur Of The Year has celebrated more than 11,000 ambitious visionaries who are leading successful, dynamic businesses in the US, and it has since expanded to nearly 60 countries globally. The US program consists of 17 regional programs whose panels of independent judges select the regional award winners every June. Those winners compete for national recognition at the Strategic Growth Forum® in November where National finalists and award winners are announced. The overall National winner represents the US at the EY World Entrepreneur Of The Year™ competition. Visit ey.com/us/eoy. About EYEY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets. Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow. EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi-disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories. All in to shape the future with confidence. EY refers to the global organization, and may refer to one or more, of the member firms of Ernst & Young Global Limited, each of which is a separate legal entity. Ernst & Young Global Limited, a UK company limited by guarantee, does not provide services to clients. Information about how EY collects and uses personal data and a description of the rights individuals have under data protection legislation are available via ey.com/privacy. EY member firms do not practice law where prohibited by local laws. For more information about our organization, please visit ey.com. About Kestra Medical Technologies, Ltd.Kestra Medical Technologies, Ltd. is a commercial-stage wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. For more information, please visit www.kestramedical.com. CONTACT: Media contact
Rhiannon Pickus
rhiannon.pickus@kestramedical.com
– Commenced market launch and first commercial sales of Symvess™ (acellular tissue engineered vessel-tyod) for the treatment of extremity vascular trauma – – Total revenues of $517,000 for quarter from sales and collaborative research agreement – – Completed public offering raising $46.7 million in net proceeds – – Implemented cost reduction to extend cash runway – —Conference call today at 8:30am ET – DURHAM, N.C., May 13, 2025 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced financial results for the first quarter ended March 31, 2025, and provided a business update. “The U.S. commercial launch of Symvess this quarter was a major milestone for Humacyte, and we are excited to provide this transformative product to surgeons and patients in need of a new option to save limbs and lives,” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “Supporting the launch is our number one priority and we are pleased by the traction gained in our interactions with hospitals, despite the current volatile economic environment. Only a few months after commercial launch, we are excited that 45 hospitals have already commenced an evaluation of Symvess as part of their Value Analysis Committee (VAC) approval process – approximately one quarter of all Level 1 trauma centers nationwide.” “We also appreciate the strong support we have received from surgeons who have treated patients with Symvess, and the resiliency of our team members, in the face of some unfounded negative press regarding Symvess and Humacyte.” continued Dr. Niklason. “Through our March 2025 financing and some recent cost reductions, we have taken steps to extend Humacyte’s cash runway. With this extended runway we will continue to aggressively expand our commercial launch, while creating value from our bioengineering pipeline. Upcoming major value drivers we anticipate include publications of additional clinical results in trauma and in dialysis access, and filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) later this year to enable first-in-human clinical testing of the small-diameter ATEV™ in coronary artery bypass grafting (CABG). As a result of reaching a major enrollment milestone in our V012 Phase 3 trial in dialysis, we are also on track for filing a supplemental Biologics License Application (BLA) for ATEV in dialysis in 2026. First Quarter 2025 and Recent Corporate Highlights Symvess Market Launch First Commercial Sales: Humacyte commenced its commercial launch of Symvess in late February 2025 after the first commercial batch was released by the FDA. The first commercial shipments containing multiple units of Symvess were made during the first quarter to three Level 1 trauma centers.VAC Approval Process: Commencement of sales to hospitals for new products typically requires review and approval by a VAC, which is a centralized decision-making body within each institution. Forty-five hospitals have already initiated the VAC approval process, with additional hospitals expected to commence the process in the near term. The VACs of five hospitals have already approved the purchase of Symvess and we expect this number to increase throughout the second quarter based on current discussions with hospitals.Military Treatment Facilities: Multiple military treatment facilities have expressed interest in purchasing Symvess. To enable these purchases, Humacyte expects shortly to be listed in the Electronic Catalog (ECAT), an internet system that provides the Department of Defense and other Federal agencies with access to manufacturers’ and distributors’ products. Economic Value of Symvess: The Company’s Budget Impact Model was published in March 2025 in the Journal of Medical Economics. Based on the model, the per-patient cost of treating patients with Symvess is estimated to be less than the cost of treating trauma patients with synthetic grafts, cryopreserved allografts, or xenografts. Major drivers of cost savings were attributed to reductions in the rate of amputation and vascular conduit infection.Manufacturing Patent: In January 2025, Humacyte was issued a new U.S. patent covering key aspects of its biomanufacturing platform. The newly issued patent provides protection into 2040 and complements a family of existing patents and patent applications encompassing the design and composition of Symvess and Humacyte’s other product candidates, and their methods of manufacture. ATEV Earlier-Stage Pipeline Major Enrollment Milestone in V012 Phase 3 Study in Dialysis: A total of 84 patients have been enrolled to date in the V012 Phase 3 clinical trial, which is designed to assess the efficacy and safety of the ATEV for dialysis in comparison to arteriovenous (AV) fistulas in female patients. An interim analysis is planned when the first 80 patients reach one-year of follow up, and this enrollment threshold was achieved in April 2025. Subject to these interim results, Humacyte’s plan is to submit a supplemental BLA in the second half of 2026, that includes data from V012 and the V007 Phase 3 pivotal studies, to add AV access for hemodialysis as an indication for the ATEV.Planned IND Filing in CABG: During the quarter Humacyte announced plans to file an IND application with the FDA to enable first-in-human clinical testing of the small-diameter (3.5mm) acellular tissue engineered vessel in CABG. Corporate Update Cost Reduction Actions: In March 2025 Humacyte completed a public offering that provided $46.7 million in net proceeds. In April and May 2025 Humacyte implemented a plan to reduce its workforce by approximately 31 employees, defer additional planned new hires, and reduce other operating expenses. These reductions have been done thoughtfully, and Humacyte has retained key personnel, resources and initiatives to meet our key corporate goals and milestones. Humacyte is undertaking cost reductions to extend its cash runway and to better align its organizational structure with its top business objectives. These objectives include the commercial launch of Symvess including sales, marketing, and manufacturing; completion of the V012 Phase 3 pivotal trial of the ATEV in dialysis and the planned filing of a supplemental BLA with the FDA in the dialysis indication, and; the filing of an IND to commence human study of the small-diameter ATEV in CABG. The Company estimates that it will incur aggregate charges representing one-time cash expenditure for severance and other employee termination benefits of approximately $0.8 million, of which the majority is expected to be incurred during the second quarter of 2025. Humacyte estimates a net savings due to the workforce reductions, operating cost reductions and reduced capital expenditures, net of termination severance and benefits, totaling approximately $13.8 million in 2025. Net savings are estimated to be up to approximately $38.0 million in 2026, for a total estimated savings of over $50 million in 2025 and 2026, relative to original budget forecasts. First Quarter 2025 Financial Highlights There was $517 thousand in revenue for the first quarter of 2025, of which $147 thousand related to the initial U.S. commercial launch of Symvess. The remaining $370 thousand resulted from a research collaboration with a large medical technology company to evaluate the potential use of Humacyte’s bioengineered human tissue in specific cardiovascular and vascular applications. There was no revenue for the first quarter of 2024.Cost of goods sold was $147 thousand for the first quarter of 2025 and includes overhead related to unused production capacity which was recorded as an expense in the period. There was no cost of goods sold for the first quarter of 2024.Research and development expenses for the first quarter of 2025 were $15.4 million compared to $21.3 million for the first quarter of 2024. The decrease in 2025 expenses compared to the prior year period resulted primarily from decreased materials costs as the Company began capitalizing expenditures for inventory during the three months ended March 31, 2025, following the commercial launch of Symvess, as well as a reduction in clinical study costs.General and administrative expenses for the first quarter of 2025 were $8.1 million compared to $5.3 million for the first quarter of 2024. The increase in 2025 expenses compared to the prior year period resulted primarily from the U.S. commercial launch of the Symvess in the vascular trauma indication, including increased personnel expenses.Other net income for the first quarter of 2025 was $62.3 million compared to net expense of $5.3 million for the first quarter of 2024. The increases in 2025 of other net income compared to the prior year period resulted primarily due to an increase in the non-cash remeasurement of the contingent earnout liability associated with the Company’s August 2021 merger with Alpha Healthcare Acquisition Corp.Net income was $39.1 million for the first quarter of 2025 compared to net loss of $31.9 million for the first quarter of 2024. The increase in 2025 net income compared to the prior year period was primarily due to the increase in the non-cash remeasurement of the contingent earnout liability described above.The Company reported cash, cash equivalents and restricted cash of $113.2 million as of March 31, 2025. Total net cash provided was $17.9 million for the first three months of 2025, compared to net cash provided of $35.1 million for the first three months of 2024. The net cash provided for the first three months of 2025 included $46.7 million in net proceeds from a public offering completed in March 2025. The decrease in net cash provided during 2025 compared to the prior year period resulted primarily from the receipt of $20 million in proceeds from a draw under its funding arrangement with Oberland Capital Management in 2024 that did not recur in 2025. Conference Call and Webcast Details Title:Humacyte First Quarter 2025 Financial Results and Corporate UpdateDate:May 13, 2025Time:8:30 AM Eastern TimeConference Call Details:1-877-704-4453 (U.S. Investors Dial) 1-201-389-0920 (International Investors Dial) 13753487 (Conference ID)Call me™Feature:Click HereWebcast:Click Here A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the investors section of the Company’s website for at least 30 days. INDICATION Symvess is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible. IMPORTANT SAFETY INFORMATION BOXED WARNING: GRAFT FAILURE Loss of Symvess integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage. CONTRAINDICATIONS DO NOT use Symvess in patients who have a medical condition that would preclude long-term antiplatelet therapy (such as aspirin or clopidogrel) after resolution of acute injuries. WARNINGS AND PRECAUTIONS Graft Rupture Vascular graft rupture has occurred in patients treated with Symvess. Advise patients that arterial bleeding can be life-threatening and to seek emergent medical evaluation for any signs or symptoms of graft rupture such as bleeding, pain and swelling in the extremity, or signs of extremity ischemia. Anastomotic Failure Anastomotic failure has occurred in patients treated with Symvess. In clinical studies of Symvess, anastomotic failure occurred within the first 36 days post-implantation. Monitor patients for signs of anastomotic failure such as pain and swelling at the surgical site, decreasing hemoglobin or other signs and symptoms of bleeding. Advise patients to seek urgent medical evaluation if they have any signs or symptoms that may be indicative of anastomotic failure such as bleeding, swelling or worsening pain at the surgical site or changes in color of overlying skin. Thrombosis Thrombosis has occurred in patients treated with Symvess. In clinical trials of Symvess, patients received antiplatelet therapy following implantation of Symvess to reduce the risk of thrombosis. The risk of thrombosis may increase in patients who discontinue antiplatelet therapy. Anti-platelet therapy is recommended following treatment with Symvess. Transmission of Infectious Diseases Symvess is manufactured using cells and reagents that may transmit infectious diseases or infectious agents. The cells used in the manufacture of Symvess are derived from a donor who met the donor eligibility requirements for transmissible infectious diseases which includes screening and testing of risks associated with human immunodeficiency virus 1 (HIV-1), human immunodeficiency virus 2 (HIV-2), hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis (Treponema pallidum). The cell banks are tested negative for human and animal viruses, retroviruses, bacteria, fungi, yeast, and mycoplasma. While all animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use, these measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Fetal bovine serum is sourced to minimize the risk of transmitting a prion protein that causes bovine spongiform encephalopathy and the cause of a rare fatal condition in humans called variant Creutzfeldt-Jakob disease. No transmissible agent infections have been reported during clinical testing. ADVERSE REACTIONS The most common adverse reactions (occurring at ≥ 10%), were vascular graft thrombosis, pyrexia (fever) and pain. Please see full Prescribing Information at www.symvess.com, including Boxed Warning, for Symvess. About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. Forward-Looking Statements This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, our plans and ability to commercialize Symvess and, if approved by regulatory authorities, our product candidates, successfully and on our anticipated timelines; the degree of market acceptance of and the availability of third-party coverage and reimbursement for Symvess and, if approved by regulatory authorities, our product candidates; our ability to manufacture Symvess and, if approved by regulatory authorities, our product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; the anticipated benefits of our ATEVs relative to existing alternatives; our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our ability to design, initiate and successfully complete clinical trials and other studies for our product candidates and our plans and expectations regarding our ongoing or planned clinical trials; the anticipated characteristics and performance of our ATEVs; the implementation of our business model and strategic plans for our business; our ability to execute and achieve the expected benefits of our cost-saving measures and whether our efforts will result in further actions or additional asset impairment charges that adversely affect our business; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.com investors@humacyte.com Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.com media@humacyte.com Humacyte, Inc. Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (unaudited) (in thousands except for share and per share amounts) Three Months EndedMarch 31, 2025 2024 Revenue: Product revenue, net$147 $— Contract revenue 370 — Total revenue 517 — Operating expenses: Cost of goods sold 147 — Research and development 15,418 21,264 General and administrative 8,136 5,314 Total operating expenses 23,701 26,578 Loss from operations (23,184) (26,578) Other income (expense), net: Change in fair value of contingent earnout liability 49,731 (4,593)Other income (expense) (net) 12,592 (725)Total other income (expense), net 62,323 (5,318)Net income (loss) and comprehensive income (loss)$39,139 $(31,896) Net income (loss) per share, basic$0.28 $(0.29)Weighted-average shares outstanding, basic 131,496,877 108,246,008 Net income (loss) per share, diluted$0.28 $(0.29)Weighted-average shares outstanding, diluted 131,759,302 108,246,008 Humacyte, Inc. Condensed Consolidated Balance Sheets (unaudited) (in thousands) March 31,2025 December 31,2023Assets Current assets: Cash and cash equivalents$62,847 $44,937 Inventory 8,020 — Prepaid expenses and other current assets 2,838 2,922 Total current assets 73,705 47,859 Restricted cash 50,209 50,209 Property and equipment, net 22,436 23,063 Finance lease right-of-use assets, net 14,966 15,490 Other long-term assets 1,237 1,251 Total assets$162,553 $137,872 Liabilities and Stockholders’ Equity (Deficit) Current liabilities: Accounts payable$5,572 $4,490 Accrued expenses 9,701 11,424 Revenue interest liability, current portion 1,690 885 Other current liabilities 3,066 3,155 Total current liabilities 20,029 19,954 Contingent earnout liability 21,230 70,961 Revenue interest liability, net of current portion 64,672 63,354 Finance lease obligation, net of current portion 12,844 13,620 Common stock warrant liabilities 3,320 19,254 Other long-term liabilities 4,415 3,398 Total liabilities 126,510 190,541 Stockholders’ equity (deficit) Common stock and additional paid-in capital 682,919 633,346 Accumulated deficit (646,876) (686,015)Total stockholders’ equity (deficit) 36,043 (52,669)Total liabilities and stockholders’ equity (deficit)$162,553 $137,872
Fort Mill, S.C., May 12, 2025 (GLOBE NEWSWIRE) — Catheter Precision (VTAK – NYSE/American), a US based medical device company focused on developing technologically advanced products for the cardiac electrophysiology market, today announced that it has entered into securities purchase agreements with institutional investors for a $1.5 million private placement equity financing and the acquisition of certain promissory notes of QHSLab, Inc.
FDA Breakthrough Device Designation Awarded to AVIM Therapy FDA IDE Approved for Virtue SAB U.S. Pivotal Trial for Launch NEW HOPE, Pa., May 12, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced financial results for the first quarter ended March 31, 2025, and provided a business update highlighting continued regulatory momentum, disciplined operational execution, and a strengthening clinical development pipeline. Q1 2025 Highlights: U.S. Food and Drug Administration (“FDA”) Breakthrough Device Designation (“BDD”) granted for atrioventricular interval modulation (“AVIM”) therapy in patients with uncontrolled hypertension and increased cardiovascular risk, with or without an indication for a pacemaker, marking a major regulatory validation of the therapy’s potential to improve hypertensive heart disease outcomes. FDA BDD enables prioritized regulatory interactions and strengthens potential access to add-on reimbursement.BACKBEAT Global Pivotal Study execution continuing to progress in strategic collaboration with Medtronic (NYSE: MDT).New Clinical Data presented demonstrating the favorable impact of AVIM therapy on cardiac function in patients with diastolic dysfunction, a key contributor to the development of heart failure, as late breaker at THT 2025.Intellectual Property Expansion continues with AVIM therapy patent estate reaching 137 issued patents worldwide, with recent additions bolstering coverage for both hypertension and heart failure indications.FDA Investigational Device Exemption (“IDE”) Approval received for the Virtue® Sirolimus AngioInfusion Balloon (“SAB”) U.S. pivotal trial, a randomized head-to-head study comparing Virtue SAB with the commercially available AGENTTM DCB paclitaxel-coated balloon (the “Virtue Trial”). Trial initiation is currently targeted for the second half of 2025. Orchestra BioMed is sponsoring and in full operational control of the Virtue Trial; mediation with Terumo of certain other contractual terms is progressing. Key Chief Executive Officer (“CEO”) Commentary: David Hochman, Chairman and CEO of Orchestra BioMed, stated: “We continued to make meaningful progress during the first quarter with significant inflection points for both our AVIM therapy and Virtue SAB programs. We believe the FDA’s Breakthrough Device Designation for AVIM therapy signals meaningful recognition of its potential to meet the clinical needs of millions living with hypertensive heart disease, a population in which chronic high blood pressure can lead to various heart problems like left ventricular hypertrophy, diastolic dysfunction, heart failure, and coronary artery disease. We believe that AVIM therapy has the potential to provide a potent additional therapeutic option for these patients. We are focused on execution of the BACKBEAT global pivotal study alongside our strategic partner Medtronic as the critical pathway toward making AVIM therapy available to patients globally.” Mr. Hochman continued, “In parallel, we secured full IDE approval to conduct the Virtue Trial, a U.S. pivotal coronary study that will evaluate Virtue SAB, our investigational, non-coated drug-eluting balloon designed to deliver a large liquid dose of proprietary extended-release sirolimus, head-to-head against the commercially available AGENT paclitaxel-coated balloon. We believe the updated design of the trial, which we currently plan to initiate in the second half of the year, offers the most direct path to regulatory approval while showcasing the distinctive pharmacokinetic and therapeutic advantages of our proprietary technology. Taken together, these milestones mark tangible progress on multiple fronts. We continue to execute methodically and remain focused on advancing our pivotal trials, generating clinical evidence, and building long-term value for patients, physicians, shareholders and strategic partners alike.” Financial Results for the First Quarter Ended March 31, 2025 Cash and cash equivalents and Marketable securities totaled $49.9 million as of March 31, 2025.Net cash used in operating activities and for the purchase of fixed assets was $16.7 million during the first quarter of 2025, compared with $13.1 million for the first quarter in 2024, with the primary driver being increased research and development costs during the first quarter of 2025.Revenue for the first quarter of 2025 was $0.9 million, compared with $0.6 million for the first quarter in 2024. The increase was primarily due to recognition of partnership revenues earned under the agreement with Terumo.Research and development expenses for the first quarter of 2025 were $13.5 million, compared with $9.1 million for the first quarter in 2024. The increase was primarily due to additional costs associated with the ongoing BACKBEAT global pivotal study.Selling, general and administrative expenses for the first quarter of 2025 were $6.3 million, compared with $5.9 million for the first quarter of 2024. The increase was primarily due to an increase in stock-based compensation and increased professional fees associated with the overall growth of the business.Net loss for the first quarter of 2025 was $18.8 million, or $0.49 per share, compared with a net loss of $13.5 million, or $0.38 per share, for the first quarter of 2024. Net loss for the first quarter of 2025 included $3.0 million in non-cash stock-based compensation expense as compared to $2.6 million for the same period in 2024. About Orchestra BioMed Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s lead product candidate is AVIM therapy for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed is also developing Virtue SAB for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. The Company has received four Breakthrough Device Designations from the U.S. FDA across these two core programs, reflecting the significant potential of its technologies to address high unmet needs in cardiovascular care. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. References to Websites and Social Media Platforms References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release. About AVIM Therapy AVIM therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will further evaluate the safety and efficacy of AVIM therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM therapy has been granted Breakthrough Device Designation by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk. About Virtue SAB Virtue SAB is an investigational therapeutic combination drug-device designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™ through a non-coated microporous AngioInfusion™ Balloon, protecting the drug in transit through the arteries and consistently delivering a large liquid dose, overcoming certain limitations of drug-coated balloons. SirolimusEFR delivered by Virtue SAB has been shown in published preclinical series involving hundreds of arterial deliveries to achieve sustained tissue levels well above the known required therapeutic tissue concentration for inhibiting restenosis (1 ng/mg tissue) for the entire critical healing period of approximately 30 days. Virtue SAB demonstrated positive three-year clinical data in coronary in-stent restenosis (“ISR”) in the SABRE study, a multi-center prospective, independent core lab-adjudicated clinical study conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for specific indications relating to coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee. The FDA granted IDE approval for Orchestra BioMed to evaluate the efficacy and safety of Virtue SAB in the Virtue Trial, a pivotal trial that will randomize Virtue SAB against commercially available AGENTTM DCB, a paclitaxel-coated balloon. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the initiation, enrollment, timing, implementation and design of the Company’s planned and ongoing pivotal trials and reporting of top-line results, including the timing of initiation of the Virtue Trial, the potential benefits of BDD, including its ability to expedite FDA reviews and allow access to add-on reimbursement, realizing the clinical and commercial value of AVIM therapy and Virtue SAB, the potential safety and efficacy of the Company’s product candidates, and the ability of the Company’s partnerships to accelerate clinical development. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 31, 2025 and the risk factor discussed under the heading “Item 1A. Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, which was filed with the SEC on May 12, 2025. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor ContactSilas NewcombOrchestra BioMed Snewcomb@orchestrabiomed.com Media ContactKelsey Kirk-EllisOrchestra BioMedKkirkellis@orchestrabiomed.com ORCHESTRA BIOMED HOLDINGS, INC.Condensed Consolidated Balance Sheets(in thousands, except share and per share data)(Unaudited) March 31, December 31, 2025 2024ASSETS CURRENT ASSETS: Cash and cash equivalents $18,348 $22,261 Marketable securities 31,536 44,551 Accounts receivable, net 89 92 Inventory 135 173 Prepaid expenses and other current assets 1,795 2,094 Total current assets 51,903 69,171 Property and equipment, net 1,413 1,384 Right-of-use assets 1,956 2,103 Strategic investments, less current portion 2,495 2,495 Deposits and other assets 1,284 1,020 TOTAL ASSETS $59,051 $76,173 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Accounts payable $5,563 $5,134 Accrued expenses and other liabilities 5,392 6,084 Operating lease liability, current portion 590 550 Deferred revenue, current portion 3,944 4,439 Total current liabilities 15,489 16,207 Deferred revenue, less current portion 10,752 10,989 Loan payable 14,338 14,292 Operating lease liability, less current portion 1,516 1,687 Other long-term liabilities 99 40 TOTAL LIABILITIES 42,194 43,215 STOCKHOLDERS’ EQUITY Preferred stock, $0.0001 par value per share; 10,000,000 shares authorized; none issued or outstanding at March 31, 2025 and December 31, 2024. — — Common stock, $0.0001 par value per share; 340,000,000 shares authorized; 38,312,512 and 38,194,442 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively. 4 4 Additional paid-in capital 345,449 342,780 Accumulated other comprehensive income 37 52 Accumulated deficit (328,633) (309,878)TOTAL STOCKHOLDERS’ EQUITY 16,857 32,958 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $59,051 $76,173 ORCHESTRA BIOMED HOLDINGS, INC.Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share data)(Unaudited) Three Months Ended March 31, 2025 2024 Revenue: Partnership revenue $732 $497 Product revenue 136 123 Total revenue 868 620 Expenses: Cost of product revenues 44 34 Research and development 13,482 9,112 Selling, general and administrative 6,263 5,897 Total expenses 19,789 15,043 Loss from operations (18,921) (14,423)Other income (expense): Interest income, net 166 1,016 Loss on fair value of strategic investments — (45)Other expense — (11)Total other income 166 960 Net loss $(18,755) $(13,463)Net loss per share Basic and diluted $(0.49) $(0.38)Weighted-average shares used in computing net loss per share, basic and diluted 38,235,409 35,777,877 Comprehensive loss Net loss $(18,755) $(13,463)Unrealized (loss) gain on marketable securities (15) 2 Comprehensive loss $(18,770) $(13,461)
– Pivotal Advance-HTN and Launch-HTN trials successfully achieved statistical significance in primary efficacy endpoints and demonstrated a favorable safety and tolerability profile – – Anticipate Explore-CKD Phase 2 trial to deliver topline data in Q2 2025 – – Initiated Explore-OSA Phase 2 Trial in Q1 2025 – – Conference call today at 4:30 p.m. ET – RADNOR, Pa., May 12, 2025 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced financial results for the first quarter ended March 31, 2025, and provided a corporate update. “We are pleased to have recently announced positive topline results from our pivotal trials, Launch-HTN and Advance-HTN, that evaluated lorundrostat’s efficacy and safety as a potential treatment for patients with uncontrolled or resistant hypertension. The Advance-HTN late-breaking presentation at the American College of Cardiology meeting and the recent publication in the New England Journal of Medicine underscore the strength of our clinical data and the potentially transformative nature of lorundrostat. With the success of our two pivotal trials, we are working toward submitting our new drug application with a pre-NDA meeting with the FDA anticipated in the fourth quarter of 2025,” stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “We are excited to announce the appointment of Eric Warren as our Chief Commercial Officer. Eric’s proven leadership skills, extensive cardiovascular experience and track record of success, will be invaluable to Mineralys as we solidify our commercial and partnering strategy.” Recent Clinical Highlights and Upcoming Milestones Pivotal Launch-HTN Phase 3 Trial – The trial met its primary endpoint in evaluating the efficacy and safety of lorundrostat for the treatment of subjects with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) as add-on therapy, who fail to achieve blood pressure control on their existing medications. The trial reported that the lorundrostat 50 mg dose achieved a 16.9 mmHg reduction in systolic blood pressure, and a 9.1 mmHg placebo-adjusted reduction (p-value < 0.0001), as assessed by automated office blood pressure at week six. This benefit was sustained with potential further reduction through week 12, with a 19.0 mmHg reduction in automated office systolic blood pressure and an 11.7 mmHg placebo-adjusted reduction (p-value 6.0 mmol/L) at the scheduled study visit was 1.1% and 1.5% in the 50 mg and 50 to 100 mg arms, respectively. After exclusion of factitious test results, the incidence of confirmed hyperkalemia was 0.6% and 1.1%, respectively. The Launch-HTN trial has been accepted as a late-breaking presentation at the 2025 European Society of Hypertension Meeting on Hypertension and Cardiovascular Protection, which is being held in Milan, Italy on May 23-26, 2025. Pivotal Advance-HTN Trial – Detailed results from the Advance-HTN trial were recently presented in a late-breaking presentation at the American College of Cardiology’s ACC.25 meeting and published on May 8th in the New England Journal of Medicine. The trial met its primary endpoints in evaluating the efficacy and safety of lorundrostat for the treatment of confirmed uHTN or rHTN. The trial reported that the lorundrostat 50 mg dose cohort achieved a 15.4 mmHg absolute reduction in systolic blood pressure and a 7.9 mmHg placebo-adjusted reduction (p-value = 0.001), as assessed by 24-hour ambulatory blood pressure monitoring at 12 weeks. Lorundrostat demonstrated a favorable safety and tolerability profile, with modest changes in serum potassium, serum sodium and eGFR, and a low discontinuation rate. The incidence of hyperkalemia (serum potassium >6.0 mmol/L) at the scheduled study visit was 5.3% and 7.4% in the 50 mg and 50 to 100 mg arms, respectively. After exclusion of factitious test results, the incidence of confirmed hyperkalemia was 2.1% and 3.2%, respectively. These results reinforce lorundrostat’s favorable benefit-risk profile in a high-risk population that would typically be treated by specialists rather than general practitioners.Transform-HTN Open-Label Extension Trial – The Company’s ongoing open-label extension trial allows subjects to continue to receive lorundrostat and the Company to obtain additional safety and efficacy data.Explore-CKD Phase 2 Trial – Enrollment has been completed and topline data are anticipated in the second quarter of 2025. The trial is designed to evaluate the safety and efficacy of lorundrostat when added to background treatment with an ACE inhibitor or ARB and a SGLT2 inhibitor for the treatment of hypertension in subjects with Stage 2 to 3b CKD (eGFR greater than or equal to 30 mL/min/1.73m2 ) and albuminuria.Explore-OSA Phase 2 Trial – The Company initiated the trial in the first quarter of 2025, which will evaluate the safety and efficacy of lorundrostat in the treatment of overweight and obese subjects with moderate-to-severe OSA and hypertension.Expanded Management Team – Appointed Eric Warren as Chief Commercial Officer. Mr. Warren brings more than three decades of commercial leadership experience across multiple healthcare segments with a heavy emphasis on cardiovascular disease. Mr. Warren will lead the Company’s commercial strategy and support future partnering opportunities.Strengthened Balance Sheet – On March 18, 2025, the Company completed a public equity financing for gross proceeds of approximately $201.2 million, before deducting fees and expenses. The Company reported a total of $343.0 million of cash, cash equivalents and investments as of March 31, 2025. First Quarter 2025 Financial Highlights Cash, cash equivalents and investments were $343.0 million as of March 31, 2025, compared to $198.2 million as of December 31, 2024. The Company believes that its current cash, cash equivalents and investments will be sufficient to fund its planned clinical trials and regulatory activities, as well as support corporate operations, into 2027. Research and Development (R&D) expenses for the quarter ended March 31, 2025 were $37.9 million, compared to $30.8 million for the quarter ended March 31, 2024. The increase in R&D expenses was primarily due to increases of $4.8 million in preclinical and clinical costs and $2.8 million in compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses and increased stock-based compensation, partially offset by $0.5 million in lower clinical supply, manufacturing and regulatory costs. General and Administrative (G&A) expenses were $6.6 million for the quarter ended March 31, 2025, compared to $4.6 million for the quarter ended March 31, 2024. The increase in G&A expenses was primarily due to $1.2 million in higher compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses and increased stock-based compensation, and $0.7 million in higher professional fees. Total other income, net was $2.2 million for the quarter ended March 31, 2025, compared to $3.9 million for the quarter ended March 31, 2024. The decrease was primarily attributable to decreased interest earned on our investments in money market funds and U.S. treasuries. Net loss was $42.2 million for the quarter ended March 31, 2025, compared to $31.5 million for the quarter ended March 31, 2024. The increase was primarily attributable to the factors impacting the Company’s expenses described above. Conference Call The Company’s management team will host a conference call at 4:30 p.m. ET on Monday, May 12, 2025. To access the call, please dial 1-800-717-1738 in the United States or 1-646-307-1865 outside the United States. A live webcast of the conference call may be found here. A replay of the call will be available on the “News & Events” page in the Investor Relations section of the Mineralys Therapeutics website (click here). About Hypertension Having sustained, elevated blood pressure (or hypertension) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the United States. In 2022, more than 685,000 deaths in the United States included hypertension as a primary or contributing cause. Hypertension and related health issues resulted in an average annual economic burden of about $219 billion in the United States in 2019. Less than 50% of hypertension patients achieve their blood pressure goal with currently available medications. Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 30% of all hypertensive patients. About CKD CKD, which is characterized by the gradual loss of kidney function, is estimated to affect more than 10% of the global population and is one of the leading causes of mortality worldwide. According to the U.S. Centers for Disease Control and Prevention (CDC), an estimated 1-in-7 (15%) of U.S. adults have CKD. Diabetes and hypertension are responsible for approximately two-thirds of CKD cases. Early detection and treatment can often keep CKD from getting worse. When CKD progresses, it may eventually lead to kidney failure, which requires dialysis or a kidney transplant to maintain life. About OSA OSA is characterized by repetitive overnight hypoxic episodes and subsequent sleep fragmentation due to a complete or partial collapse of the upper airway. Moderate OSA is defined as having between 15 and 30 breathing pauses (apnea or hypopnea events) per hour of sleep, while severe OSA indicates more than 30 breathing pauses per hour. OSA impacts almost one billion people globally, including 425 million moderate-to-severe cases. Around 80% of adults with OSA are undiagnosed. As of 2015, undiagnosed OSA is estimated to cost the United States approximately $149.6 billion annually from comorbid disease, workplace accidents, motor vehicle accidents and loss of workplace productivity. Between 30-50% of adults with hypertension have OSA, and this number increases to between 70-80% in adults with rHTN. Additionally, untreated moderate-to-severe OSA increases the risk of rHTN. Along with hypertension, OSA is a major risk factor of cardiovascular disease, type-2 diabetes mellitus and stroke. About Lorundrostat Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uHTN or rHTN, as well as CKD and OSA. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated a 40-70% reduction in plasma aldosterone concentration in hypertensive subjects. In a Phase 2, proof-of-concept trial (Target-HTN) in uncontrolled or resistant hypertensive subjects, once-daily lorundrostat demonstrated statistically significant and clinically meaningful systolic blood pressure reduction in both automated office systolic blood pressure measurement and 24-hour ambulatory systolic blood pressure monitoring. Adverse events observed were a modest increase in serum potassium, decrease in eGFR, urinary tract infection and hypertension, with one serious adverse event possibly related to study drug being hyponatremia. About Mineralys Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is developing for the treatment of cardiorenal conditions affected by dysregulated aldosterone, including hypertension, CKD and OSA. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn and Twitter. Forward-Looking Statements Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat; the Company’s expectation that aldosterone synthase inhibitors with an SGLT2 inhibitor may provide additive clinical benefits to patients; the Company’s expectation that Advance-HTN and Launch-HTN may serve as pivotal trials in any submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA); the Company’s ability to evaluate lorundrostat as a potential treatment for CKD, OSA, uHTN or rHTN; the planned future clinical development of lorundrostat and the timing thereof; and the expected timing of commencement and enrollment of patients in clinical trials and topline results from clinical trials. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: topline results that we report are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; later developments with the FDA may be inconsistent with the feedback from the completed end of Phase 2 meeting, including whether the proposed pivotal program will support registration of lorundrostat which is a review issue with the FDA upon submission of an NDA; the results of our clinical trials, including the Advance-HTN and Launch-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for an NDA submission or regulatory approval of lorundrostat; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs, and the potential for a local and/or global economic recession; our ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; our reliance on our exclusive license with Mitsubishi Tanabe Pharma to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact:Investor Relationsinvestorrelations@mineralystx.com Media RelationsTom WeibleElixir Health Public RelationsPhone: (1) 515-707-9678Email: tweible@elixirhealthpr.com Mineralys Therapeutics, Inc.Condensed Statements of Operations(in thousands, except share and per share data)(unaudited) Three Months Ended March 31, 2025 2024 Operating expenses: Research and development $37,879 $30,754 General and administrative 6,568 4,608 Total operating expenses 44,447 35,362 Loss from operations (44,447) (35,362)Interest income, net 2,239 3,853 Other income (expense) (3) 1 Total other income, net 2,236 3,854 Net loss $(42,211) $(31,508)Net loss per share attributable to common stockholders, basic and diluted $(0.79) $(0.70)Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted 53,163,551 44,900,755 Mineralys Therapeutics, Inc.Selected Financial InformationCondensed Balance Sheet Data(amounts in thousands)(unaudited) March 31, December 31, 2025 2024 Cash, cash equivalents and investments $343,026 $198,187 Total assets $354,941 $205,903 Total liabilities $13,386 $14,646 Total stockholders’ equity $341,555 $191,257
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