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Continued Momentum Toward PMA Submission of ULTC Technologies Recent Financing Positions Company to Execute Growth Strategy LAGUNA HILLS, Calif.–(BUSINESS WIRE)–Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced financial results for the third quarter […]
MINNEAPOLIS, Minn. and BRISBANE, Australia , Nov. 12, 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 September 30, 2025, and provided a corporate update. Third Quarter 2025 Highlights Continued FDA engagement during the Quarter to advance the IDE for the PARADIGM Trial, with FDA approval to commence U.S. recruitment* announced in November 2025Advanced European regulatory activities to initiate the PARADIGM Trial across multiple countries, with the first PARADIGM patients treated in Denmark following regulatory approval from the Danish Medicines Agency in October 2025Progressed site and operational readiness across the United States, Europe and Canada ahead of anticipated trial enrolmentStrengthened operational and quality systems while advancing manufacturing scale-up to support clinical activities including ISO 13485 certification for DurAVR® THV productionReceived approval from the Company’s stockholders for ASX Limited’s grant to the Company of a waiver from ASX Listing Rule 7.1 “Third Quarter activities were critical to set the company on its path for the rest of the year and into 2026. The company made significant progress on the regulatory front with approvals to start the PARADIGM pivotal study being achieved in both Europe and the U.S. in Q4 as a result,” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris. Business & Operations DurAVR® THV Commercialisation Update Activities supporting the launch of the PARADIGM Trial During the third quarter of 2025, the company maintained positive engagement with the United States Food and Drug Administration (FDA) to advance the Investigational Device Exemption (IDE) for the PARADIGM Trial, submitting a formal response to address requests for additional information, including a completed simulated use study. FDA approval to commence patient recruitment* in the United States was subsequently announced in November 2025. Anteris also advanced European regulatory activities aimed at securing approval to commence the PARADIGM Trial in countries including Germany, France and the Netherlands, with the first European approval secured in Denmark in October 2025. In parallel, cross-functional teams completed site and operational readiness activities, namely investigator training, study material preparation, and logistical set up, ahead of anticipated enrolment and pending receipt of regulatory clearance and Institutional Review Board (IRB) approval. The first PARADIGM patients were enrolled and treated in Denmark following regulatory approval from the Danish Medicines Agency in October 2025. The Company continued strengthening its operational infrastructure during the quarter, advancing quality management system (QMS) buildout to support upcoming clinical activities and future ISO 13485 certification. Key quality procedures and standard operating documents were released to establish the framework for a mature, compliant system and to mitigate audit risk. In parallel, manufacturing scale-up activities progressed, including cross-training of inspection personnel, expansion of clean room capacity, and ongoing process development initiatives for projected DurAVR® THV demand. The financial results for Anteris for the quarter ended September 30, 2025, are reviewed below. All amounts in $ refer to U.S. dollars. The Company’s net operating cash outflows for the nine months ended September 30, 2025, were $59.3 million, in line with the increase in clinical, regulatory and manufacturing requirements to support the PARADIGM Trial. Reflecting this clinical focus, the key areas of the Company’s operating expenditure for the three months ended September 30, 2025, were as follows: R&D expenses were $16.8 million. The key activities undertaken were the preparatory activities linked to the PARADIGM Trial, including regulatory work regarding the IDE and extensive engagement with planned investigators at clinical trial sites by the Clinical Specialist Team, who work directly with physicians in the Cath Lab to support appropriate use of the device and procedural success. Additionally, there were further costs associated with upscaling of manufacturing capabilities, including completion of design validation processes and documentation, and continued portfolio development aimed at driving long-term growth beyond the current products. Selling, general and administrative expenses were $5.8 million. The Company held $9.1 million of cash and cash equivalents as of September 30, 2025. Anteris refers to the detailed Financial Information contained in its Form 10-Q filing including the Management Discussion & Analysis and the Risks. About the PARADIGM Trial The PARADIGM Trial is a prospective randomized controlled trial (RCT) which will evaluate the safety and effectiveness of the DurAVR® THV compared to commercially available transcatheter aortic valve replacements (TAVRs). This head-to-head study will enrol approximately 1,000 patients across the United States, Europe and Canada in the ‘All Comers Randomized Cohort’ with 1:1 randomization of patients who will receive either the DurAVR® THV or TAVR using commercially available and approved THVs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure. 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. For further information about the PARADIGM Trial, please refer to ClinicalTrials.gov (ClinicalTrials.gov ID NCT07194265). *Subject to Institutional Review Board (IRB) approval 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 collaboration 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, plans for and size of Anteris’ studies and trials. 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. For more information: Investor Relations Investor Relations (US)investors@anteristech.com mchatterjee@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 Website www.anteristech.comX@AnterisTechLinkedIn https://www.linkedin.com/company/anteristech
PDUFA Target Date of December 13, 2025 for CARDAMYST™ (etripamil) Nasal Spray in Paroxysmal Supraventricular Tachycardia (PSVT) Promotional Launch Plans Set with Quick-Start Capability Upon Potential FDA Approval $82.6 million in Cash at September 30; Successful Equity Offering and Amended Royalty Purchase Agreement Provide Resources for Successful Launch MONTREAL and CHARLOTTE, N.C., Nov. 12, 2025 (GLOBE NEWSWIRE) — Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the third quarter ending September 30, 2025, and provided corporate and regulatory updates. “We are approaching our December 13 Prescription Drug User Fee Act (PDUFA) date with optimism and excitement for the opportunity to bring CARDAMYST (etripamil) nasal spray to patients suffering from symptomatic PSVT,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “Our team has recently increased our pre-launch activities to better enable market readiness. We strengthened our balance sheet with a successful equity financing last quarter, and together with the $75 million royalty payment upon FDA approval, we believe we have resources in place to drive a successful commercial launch.” Third Quarter and Program Updates Etripamil for patients with PSVT A New Drug Application (NDA) for CARDAMYST is currently being reviewed by the U.S. Food and Drug Administration (FDA), with a PDFUA action date of December 13, 2025. Milestone has strengthened our commercialization capabilities and plans to launch CARDAMYST quickly following FDA approval. New analysis of etripamil clinical data presented at the American Heart Association (AHA) Scientific Sessions 2025 on November 10. Results from more than 600 unique enrolled patients showed aligned efficacy and safety of etripamil across multiple study phases, types of trial design, and geographic regions, with etripamil treatment achieving consistently greater conversion rates for symptomatic PSVT episodes compared with placebo arms.Recent presentations and peer-reviewed publications highlight the growing body of data supporting etripamil nasal spray as a potential rapid, self-administered treatment for PSVT and AFib-RVR. Importantly, etripamil was referenced in recent AHA ACLS Guidelines noting the potential of intranasal calcium channel blockers for future treatment algorithms. Separately, NODE-303 long-term safety data were published in the Journal of Cardiovascular Electrophysiology. Etripamil for patients with atrial fibrillation with rapid ventricular rate (AFib-RVR) Phase 3 protocol of etripamil in AFib-RVR (ReVeRA-301) finalized. Milestone is poised to enter a pivotal Phase 3 program in AFib-RVR, on the strength of the successful ReVeRA Phase 2 trial. The Company intends to follow the supplemental NDA regulatory approval pathway, discussed with the FDA, and expects to leverage data from the PSVT NDA along with the results from the planned single AFib-RVR Phase 3 study for what would potentially be a second indication for etripamil. The ReVeRA-301 study design for etripamil in AFib-RVR was presented at HRX 2025. Third Quarter and Recent Corporate Updates Milestone well-financed for potential CARDAMYST launch from recent public equity offering and amended Royalty Purchase Agreement (RPA). The Company completed an underwritten public offering providing immediate net proceeds of approximately $48.7 million and amended RPA in July 2025. The proceeds from the offering and RPA are expected to fund the continued development and commercial launch of CARDAMYST in its lead indication of PSVT, following potential FDA approval around the PDUFA date of December 13th. Third Quarter 2025 Financial Results As of September 30, 2025, Milestone had cash, cash equivalents, and short-term investments of $82.6 million, compared to $69.7 million as of December 31, 2024.No revenue was reported in the third quarter ended September 30, 2025 or for the third quarter of 2024.Research and development expense for the third quarter of 2025 was $3.9 million, compared with $4.0 million for the prior year period. For the nine months ended September 30, 2025, research and development expense was $12.6 million compared with $10.4 million for the same period in 2024. The increase was primarily due to higher consulting and outside service costs that were partially offset by lower personnel-related costs.General and administrative expense for the third quarter of 2025 was $3.3 million, compared with $3.7 million for the prior year period. For the nine months ended September 30, 2025, general and administrative expense was $12.2 million, compared with the $12.7 million for the prior year period. The decrease between the quarters is primarily due to a decrease in professional fees and personnel costs.Commercial expense for the third quarter of 2025 was $4.6 million, compared with $1.9 million for the prior year period. For the nine months ending September 30, 2025, commercial expense was $20.1 million compared with $6.6 million for the prior year period. These increases are a result of additional personnel costs, professional costs and other operational expenses related to preparation for the launch of CARDAMYST. With the resolution of the Complete Response Letter (CRL) we are now ramping operational expenditures in order to launch quickly following the potential approval of CARDAMYST by the FDA.For the third quarter of 2025, net loss was $11.9 million, compared to $9.4 million for the prior year period. For the nine months ended September 30, 2025, Milestone’s net loss was $45.6 million, compared to $29.2 million in the prior year period. For further details on the Company’s financials, refer to the Quarterly Report on Form 10-Q for the quarter ending September 30, 2025, filed with the SEC on November 12, 2025. 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 approval of the NDA for CARDAMYST for PSVT; Milestone’s ability to receive additional cash proceeds from the warrants issued in the Offering; Milestone’s ability to receive the $75.0 million royalty payment under the Royalty Purchase Agreement on the timeline provided, or at all; Milestone’s expected operating runway; CARDAMYST’s potential as a novel treatment option to help patients with PSVT; Milestone’s ability to make CARDAMYST quickly available to PSVT patients following FDA approval, if received; the success of Milestone’s launch infrastructure; 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 June 30, 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: Investor Relations Kevin Gardner, kgardner@lifesciadvisors.com Milestone Pharmaceuticals Inc.Condensed Consolidated Balance Sheets (Unaudited)(in thousands of US dollars, except share data) September 30, 2025 December 31, 2024Assets Current assets Cash and cash equivalents $46,685 $25,314 Short-term investments 35,900 44,381 Research and development tax credits receivable 808 901 Prepaid expenses 2,577 1,840 Other receivables 700 1,490 Total current assets 86,670 73,926 Operating lease right-of-use assets 944 1,376 Property and equipment 136 197 Total assets $87,750 $75,499 Liabilities, and Shareholders’ Equity Current liabilities Accounts payable and accrued liabilities $10,041 $7,555 Operating lease liabilities 483 571 Total current liabilities 10,524 8,126 Operating lease liabilities, net of current portion 519 874 Senior secured convertible notes 56,206 53,352 Total liabilities 67,249 62,352 Shareholders’ Equity Common shares, no par value, unlimited shares authorized, 85,169,344 shares issued and outstanding as of September 30, 2025, 53,353,984 shares issued and outstanding as of December 31, 2024 311,776 288,048 Pre-funded warrants – 16,412,925 issued and outstanding as of September 30, 2025 and 12,910,590 as of December 31, 2024 55,649 53,076 Additional paid-in capital 66,270 39,568 Accumulated deficit (413,194) (367,545) Total shareholders’ equity 20,501 13,147 Total liabilities and shareholders’ equity $87,750 $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 September 30, Nine months ended September 30, 2025 2024 2025 2024 Revenue $— $— $— $— Operating expenses Research and development, net of tax credits 3,940 3,963 12,587 10,417 General and administrative 3,263 3,742 12,189 12,741 Commercial 4,626 1,911 20,107 6,596 Loss from operations (11,829) (9,616) (44,883) (29,754) Interest income 874 1,080 2,087 3,260 Interest expense (967) (903) (2,853) (2,662) Net loss and comprehensive loss $(11,922) $(9,439) $(45,649) $(29,156) Weighted average number of shares and pre-funded warrants outstanding, basic and diluted 96,494,588 66,190,302 76,497,361 60,856,495 Net loss per share, basic and diluted $(0.12) $(0.14) $(0.60) $(0.48)
– Total revenues of $753,000 for third quarter, and $1,571,000 for first nine months of 2025, from sales and collaborative research agreement – – Major advances in pipeline as Humacyte moves closer to planned BLA filing in dialysis and first-in-human studies in cardiac bypass graft surgery – – IND submitted to the FDA for the CABG indication – – Symvess™ and pipeline programs highlighted in multiple scientific publications and presentations – – Conference call today at 8:00 am ET – DURHAM, N.C., Nov. 12, 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 third quarter ended September 30, 2025, and provided a business update. “During the third quarter of 2025 we continued to execute on our U.S. commercial launch of Symvess with sales increasing substantially, totaling $703,000 for third quarter compared to $100,000 in second quarter,” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “This significant ramp-up is due to an increased number of individual hospital and healthcare system Value Analysis Committee (VAC) approvals, our recent inclusion in the U.S. Defense Logistics Agency’s Electronic Catalog (ECAT), and the tireless work of our commercial and medical teams in educating the vascular surgery community about the benefits of Symvess.” “The launch of Symvess in the vascular trauma indication is just the first of the many planned products emerging from our proprietary bioengineering platform, and the advancement of our broader pipeline was supported by multiple events during the quarter,” continued Dr. Niklason. “The acellular tissue engineered vessel (ATEV™) is moving closer to our planned supplemental Biologics License Application (BLA) filing in dialysis access. This planned dialysis indication is supported by positive two-year results from the V007 Phase 3 trial presented last weekend at Kidney Week 2025, which is the world’s largest nephrology meeting. For coronary artery bypass grafting (CABG), we published positive results of a preclinical study evaluating our coronary tissue engineered vessel (CTEV) in non-human primates. These results support our plans to advance the CTEV into a human study in CABG in 2026. If successful, the CTEV would be the first novel conduit tested in CABG in the US in decades. Lastly, we expanded our intellectual property estate with the grant of a new U.S. patent for our bioengineered esophagus, complementing our existing intellectual property in urinary conduits and tracheas, all of which can be produced using our proprietary regenerative tissue engineering platform.” Third Quarter 2025 and Recent Corporate Highlights Symvess Market Launch and Expanded Clinical Results VAC Approval Process and Sales: There are now a total of 25 VAC approvals of the Symvess product compared to 13 as of the date of the August 2025 quarterly report. As these VAC approvals include multi-hospital networks, 92 civilian hospitals are now eligible to purchase Symvess. Furthermore, an additional 45 VAC committees are currently conducting their review processes. To date, 16 hospitals have ordered Symvess, with the majority placing re-orders.Publication of Outcomes for Patients with Hospital-Acquired Vascular Complications Treated with Symvess: A September 2025 publication in the Journal of Vascular Surgery reported that Symvess was observed to have high levels of patency, 100% limb salvage, and zero cases of conduit infection in 12 patients with hospital-acquired iatrogenic injuries or complications of vascular surgical procedures. Complications of surgery and vascular procedures, including iatrogenic injuries, planned oncological tumor resections, and steal syndrome following arteriovenous access placement, are increasingly common in modern medical care, and are reported to comprise close to 30% of patients requiring vascular injury repair.Long-term Results for Ukrainian Patients Published: An October 2025 publication in Oxford Academic’s Military Medicine described positive long-term results from a humanitarian program using Symvess to treat wartime vascular injuries in Ukraine. The publication, titled “Evaluating the Safety and Efficacy of Humacyte Acellular Tissue-Engineered Vessel in a Real-World Combat Setting: A Retrospective Observational Multicenter Study,” reported on 17 trauma patients with wartime extremity injuries who were treated with Symvess and were followed for up to 18 months. These wartime patients were observed to have a high patency rate of 87.1%, along with 100% limb salvage, and zero cases of conduit infection, showing the durability of Symvess in treatment of real-world combat injuries.New Data Comparing Symvess to Autologous Vein Published in Trauma Surgery & Acute Care: A new study comparing clinical outcomes of Symvess to autologous vein in the treatment of extremity arterial trauma was published in the American Association for the Surgery of Trauma (AAST)’s Trauma Surgery & Acute Care Open Journal in October 2025. In comparison to pre-existing patients in a trauma registry who were treated with autologous vein, patients treated with Symvess experienced similar short-term outcomes for patency, limb salvage, and infection. ATEV in Dialysis Progresses Toward Planned BLA Filing Positive V007 Phase 3 Study Two-Year Results in Dialysis Highlighted at Kidney Week 2025 Conference: Positive two-year results from the V007 Phase 3 trial of the ATEV in dialysis patients were presented in November 2025 at the American Society of Nephrology’s Kidney Week 2025, which is the premier nephrology meeting. The ATEV was observed to have superior duration of use over 24 months compared to autogenous fistula in high-need subgroups having historically poor outcomes with arteriovenous (AV) fistula procedures. The significantly longer duration of ATEV use could greatly reduce reliance on catheters for dialysis access, a major cause of complications, morbidity and costs for dialysis patients in these high-need subgroups.ATEV Progresses Toward Planned Supplemental BLA Filing: A total of 109 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 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 plans to submit a supplemental BLA in the second half of 2026, including data from V012 and the V007 Phase 3 pivotal studies, to add dialysis as an indication for the ATEV. Pipeline Progress Coronary Tissue Engineered Vessel (CTEV) Progresses Toward First Human Study: Positive results of a preclinical study evaluating the CTEV as a coronary artery bypass graft conduit in a non-human primate model were published in September 2025 in JACC: Basic to Translational Science, which is a specialist journal launched by the Journal of the American College of Cardiology (JACC). In the study, the CTEV was observed to sustain blood flow, recellularize with the animals’ host cells, and remodel to bring the diameter of the CTEV in line with the animals’ own native coronary artery. Humacyte plans to advance CTEV into first-in-human study in CABG in 2026. In preparation for the trial. Humacyte has submitted an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) for the CABG indication.New U.S. Patent for Bioengineered Esophagus: Humacyte announced the expansion of its intellectual property for its pipeline products with the grant of a new U.S. Patent covering the composition of a bioengineered esophagus. The patent, titled “Tubular Prostheses (Esophagus),” provides protection into 2041 of key structural and mechanical attributes for its designed use as an esophageal replacement including size, strength, and methods of production. Humacyte’s Tubular Prostheses patent family now encompasses claims granted for the composition and methods for engineered trachea, engineered urinary conduit, and engineered esophagus. Third Quarter 2025 Financial Highlights There was $0.8 million in revenue for the three months ended September 30, 2025, of which $0.7 million related to U.S. sales of Symvess. The remaining $0.1 million 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. Revenue for the nine months ended September 30, 2025 was $1.6 million, of which $0.9 million related to U.S. sales of Symvess and $0.6 million resulted from the research collaboration. There was no revenue for either the three or nine months ended September 30, 2024.Cost of goods sold was $0.3 million and $0.6 million for the three and nine months ended September 30, 2025, respectively, which includes overhead related to unused production capacity that was recorded as an expense in the applicable period. There was no cost of goods sold for either the three or nine months ended September 30, 2024.Research and development expenses were $17.3 million for the three months ended September 30, 2025 compared to $22.9 million for the three months ended September 30, 2024, and were $54.7 million for the nine months ended September 30, 2025 compared to $67.9 million for the nine months ended September 30, 2024. The decrease in research and development expenses for the third quarter of 2025 compared to 2024 primarily related to the capitalization of material and overhead costs associated with the commercial manufacturing of Symvess, and cost reductions implemented during the quarter ended June 30, 2025. The decrease in research and development expenses for the nine months ended September 30, 2025 compared to 2024 resulted primarily from decreased materials costs as the Company began capitalizing expenditures for inventory following the commercial launch of Symvess and the winding down of certain clinical trial programs, partially offset by higher non-commercial production runs.Selling, general and administrative expenses were $7.6 million for the three months ended September 30, 2025 compared to $7.3 million for the three months ended September 30, 2024, and were $23.6 million for the nine months ended September 30, 2025 compared to $18.4 million for the nine months ended September 30, 2024. The increase in 2025 expenses compared to the prior year periods resulted primarily from the U.S. commercial launch of the Symvess in the vascular trauma indication, including increased personnel expenses.Other net income (expense) for the three months ended September 30, 2025 was net income of $6.9 million compared to net expense of $9.0 million for the three months ended September 30, 2024, and other net income was $61.3 million for the nine months ended September 30, 2025 compared to other net expense of $41.5 million for the nine months ended September 30, 2024. The increase in other net income for the three and nine months ended September 30, 2025 compared to the prior year periods resulted primarily from the non-cash remeasurement of the contingent earnout liability associated with the Company’s August 2021 merger with Alpha Healthcare Acquisition Corp.Net loss was $17.5 million for the three months ended September 30, 2025 compared to net loss of $39.2 million for the three months ended September 30, 2024, and net loss was $16.0 million for the nine months ended September 30, 2025, compared to net loss of $127.8 million for the nine months ended September 30, 2024. The decrease in net loss for the three and nine months ended September 30, 2025 compared to the prior year periods was primarily due to the non-cash remeasurement of the contingent earnout liability described above combined with current-period decreases in operating expenses and loss from operations.The Company reported cash, cash equivalents and restricted cash of $19.8 million as of September 30, 2025. In addition, subsequent to September 30, 2025, the Company completed the sale of common stock and warrants that resulted in net proceeds of approximately $56.5 million. Total net cash used in operating activities was $78.9 million for the first nine months of 2025, compared to $71.5 million for the first nine months of 2024. The increase in net cash used in operating activities for the first nine months of 2025 compared to the prior year resulted primarily from the buildup in inventory associated with the commercial launch of Symvess, partially offset by a reduced loss from operations. Conference Call and Webcast Details Title:Humacyte Third Quarter 2025 Financial Results and Corporate UpdateDate:November 12, 2025Time:8:00 AM Eastern TimeConference Call Details:1-877-704-4453 (U.S. Investors Dial)1-201-389-0920 (International Investors Dial)13754596 (Conference ID)Call meTMFeature: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. 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 and our CTEVs 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 plans, anticipated timeline and ability to file applications for, and obtain marketing approvals from, the FDA and other regulatory authorities, including the European Medicines Agency, for our ATEVs, CTEVs and product candidates; 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 and our CTEVs; our ability to use our proprietary scientific technology platform to build a pipeline of additional product candidates; the implementation of our business model and strategic plans for our business; and 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. 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 and Form 10-Q for the quarter ended June 30, 2025, each 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.cominvestors@humacyte.com Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@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 Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Revenue: Product revenue, net $703 $— $950 $— Contract revenue 50 — 621 — Total revenue 753 — 1,571 — Operating expenses: Cost of goods sold 260 — 620 — Research and development 17,273 22,926 54,697 67,943 Selling, general and administrative 7,610 7,307 23,555 18,367 Total operating expenses 25,143 30,233 78,872 86,310 Loss from operations (24,390) (30,233) (77,301) (86,310) Other income (expense), net: Change in fair value of contingent earnout liability 4,893 (8,489) 49,154 (38,653)Other income (expense) (net) 1,987 (480) 12,118 (2,798)Total other income (expense), net 6,880 (8,969) 61,272 (41,451)Net loss and comprehensive loss $(17,510) $(39,202) $(16,029) $(127,761) Net loss per share, basic and diluted $(0.11) $(0.33) $(0.11) $(1.10)Weighted-average shares outstanding, basic and diluted 158,313,290 119,408,565 148,514,044 115,623,616 Humacyte, Inc.Condensed Consolidated Balance Sheets(unaudited)(in thousands) September 30,2025 December 31,2024Assets Current assets: Cash and cash equivalents $19,488 $44,937 Inventory 18,418 — Prepaid expenses and other current assets 3,445 2,922 Total current assets 41,351 47,859 Restricted cash 209 50,209 Property and equipment, net 19,857 23,063 Finance lease right-of-use assets, net 29,420 15,490 Other long-term assets 672 1,251 Total assets $91,509 $137,872 Liabilities and Stockholders’ Equity (Deficit) Current liabilities: Accounts payable $9,575 $4,490 Accrued expenses 10,264 11,424 Revenue interest liability, current portion 3,072 885 Other current liabilities 2,670 3,155 Total current liabilities 25,581 19,954 Revenue interest liability, net of current portion 17,674 63,354 Contingent earnout liability 21,807 70,961 Finance lease obligation, net of current portion 27,155 13,620 Common stock warrant liabilities 3,234 19,254 Other long-term liabilities 809 3,398 Total liabilities 96,260 190,541 Stockholders’ equity (deficit) Common stock and additional paid-in capital 697,293 633,346 Accumulated deficit (702,044) (686,015)Total stockholders’ equity (deficit) (4,751) (52,669)Total liabilities and stockholders’ equity (deficit) $91,509 $137,872
ST. LOUIS, Nov. 11, 2025 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today reported financial results for the third quarter ended September 30, 2025.
Partnership leverages ARTELLA’S Active State Monitoring SaaS platform and Certified Independent Diagnostic Testing Facility (IDTF) with Future Cardia’s Implantable Cardiac Devices. HOUSTON & TAMPA, Fla.–(BUSINESS WIRE)–Future Cardia, a medical device company developing an implantable cardiac monitor intended to capture electrocardiogram (ECG) signals, and Artella Solutions Inc. (“ARTELLA”), a remote cardiac monitoring software […]
EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX) (“Surmodics” or the “Company”), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that the United States District Court for the Northern District of Illinois (the “District Court”) has denied a request by the […]
SAN MATEO, Calif. & RIYADH, Saudi Arabia–(BUSINESS WIRE)–RapidAI, the pioneer of deep clinical AI and global leader in intelligent imaging and workflow integration, today announced a strategic partnership and co-development with Saudi Health Holdings Company (HHC), the largest healthcare provider in the Middle East. Through this collaboration, RapidAI will serve […]
Secured $147.6 million in proceeds and committed capital following completion of strategic transactions and concurrent public and private equity offerings, led by $71.6 million in committed capital from Medtronic and Ligand, as well as $30 million from TerumoInitiated patient enrollments in the Virtue Trial evaluating Virtue® Sirolimus AngioInfusion™ Balloon (“Virtue SAB”) trial versus commercially available paclitaxel-coated balloon Demonstrated partnership-driven business model execution with expanded strategic collaboration with Medtronic and new right of first refusal agreement with Terumo NEW HOPE, Pa., Nov. 10, 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 third quarter ended September 30, 2025, and provided a business update highlighting recent financial and regulatory milestones. Q3 2025 and Recent Business Highlights: Completed multiple strategic transactions and concurrent public and private equity offerings totaling $147.6 million in gross proceeds to support continued advancement of the Company’s pivotal trial-stage Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) and Virtue SAB clinical programs. Gross proceeds are comprised of: $55 million received or to be received by May 1, 2026, subject to certain conditions, in strategic investments from Ligand Pharmaceuticals Incorporated (Nasdaq: LGND, “Ligand”) and Medtronic, plc (NYSE: MDT, “Medtronic”)$62.6 million received from a $46 million oversubscribed, underwritten public offering of common stock and prefunded warrants and $11.6 million and $5 million received from private placements of common stock to Medtronic and Ligand, respectively$30 million received from Terumo Corporation, including a $10 million payment in exchange for granting Terumo a right of first refusal (“ROFR”) and a $20 million purchase of non-voting preferred stock, convertible into common stock at a minimum of $12 per share (the “Preferred Stock”) Extended cash runway into Q4 2027, supporting potentially significant value-creating catalysts, including: BACKBEAT study enrollment completion in mid-2026Follow up for the BACKBEAT study primary endpoint dataCompletion of enrollment of the Virtue Trial (as defined below) in mid-2027 Initiated patient enrollments in the Virtue SAB U.S. pivotal trial, a randomized head-to-head IDE registrational clinical trial comparing Virtue SAB with the commercially available AGENT™ DCB paclitaxel-coated balloon for the treatment of coronary in-stent restenosis (the “Virtue Trial”). Target completion of enrollment is expected in mid-2027.Entered into new strategic rights agreement with Terumo, superseding prior agreement which is now terminated, and providing Terumo with a ROFR with respect to certain strategic transactions relating to Virtue SAB for the treatment of coronary artery disease. Orchestra BioMed retains all development and distribution rights for Virtue SAB across all indications and has strategic optionality to explore potential transactionsOrchestra BioMed is sponsoring and in full operational control of the Virtue TrialOrchestra BioMed received $30 million for granting the ROFR and selling Terumo the Preferred Stock in additional payments on top of the prior $30 million payment and $5 million equity investment Expanded strategic collaboration with Medtronic, providing pathway for future development of AVIM Therapy-enabled leadless pacemakers.Implemented FDA-approved BACKBEAT global pivotal study protocol enhancements, broadening patient enrollment criteria for a more than 24-fold increase in the potentially eligible patient pool. Chairman and Chief Executive Officer Commentary from David Hochman: Mr. Hochman stated: “The last several months have been a period of exceptional execution, during which we secured nearly $150 million in capital and committed capital, positioning Orchestra BioMed to advance both of our pivotal-stage, high-impact programs with full momentum. Enrollment is actively underway in our pivotal, registrational trials for both AVIM Therapy and Virtue SAB. We are proud to have achieved a favorable realignment with Terumo, expanded our collaboration with Medtronic, and secured significant additional funding on terms we believe are highly attractive for shareholders, including a new strategic financial partnership with Ligand. As a result, we are well-financed through key clinical and regulatory milestones. We believe 2026 will be a landmark year for Orchestra, with the target completion of enrollment in the BACKBEAT study and active execution of the Virtue Trial toward completion of enrollment in the Virtue Trial in 2027.” Financial Results for the Third Quarter Ended September 30, 2025 Cash and cash equivalents and Marketable securities totaled $95.8 million as of September 30, 2025. On November 7, 2025, we received $30.0 million pursuant to new strategic rights and Terumo stock purchase agreements. The Company has commitments from Ligand and Medtronic to receive a combined $35.0 million in additional proceeds on or before May 1, 2026, based on the terms of agreements with those parties.Net cash used in operating activities and for the purchase of fixed assets was $14.9 million during the third quarter of 2025, compared with $13.8 million for the third quarter in 2024, with the primary driver being increased research and development costs during the third quarter of 2025.Revenue for the third quarter of 2025 was $0.9 million, compared with $1.0 million for the third quarter in 2024.Research and development expenses for the third quarter of 2025 were $14.0 million, compared with $11.6 million for the third 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 third quarter of 2025 were $7.1 million, compared with $5.7 million for the third quarter of 2024. The increase was primarily due to an increase in professional fees.Net loss for the third quarter of 2025 was $20.8 million, or $0.40 per share, compared with a net loss of $15.4 million, or $0.41 per share, for the third quarter of 2024. Net loss for the third quarter of 2025 included $3.0 million in non-cash stock-based compensation expense as compared to $2.4 million for the same period in 2024. About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates – Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) – are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic (NYSE: MDT), one of the largest medical device companies in the world, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designation for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind drug delivery angioplasty balloon system designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and below-the-knee peripheral artery disease. 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 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 SABVirtue SAB is a highly differentiated, first-of-its-kind drug delivery angioplasty balloon system designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™. It uses a non-coated microporous AngioInfusion™ Balloon to protect the drug in transit and consistently deliver 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 ISR in the SABRE study, a multi-center, prospective, independent core lab-adjudicated clinical study of 50 patients conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee. 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 ongoing pivotal trials, including the timing of completion of enrollment in the BACKBEAT study and the Virtue Trial, the receipt of committed capital, the Company’s expected cash runway, 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 Condensed Consolidated Balance Sheets(in thousands, except share and per share data)(Unaudited) September 30, December 31, 2025 2024 ASSETS CURRENT ASSETS: Cash and cash equivalents $42,012 $22,261 Marketable securities 53,808 44,551 Accounts receivable, net 52 92 Inventory 365 173 Prepaid expenses and other current assets 1,531 2,094 Total current assets 97,768 69,171 Property and equipment, net 1,595 1,384 Right-of-use assets 1,653 2,103 Strategic investments, less current portion 2,495 2,495 Deposits and other assets 1,296 1,020 TOTAL ASSETS $104,807 $76,173 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Accounts payable $8,473 $5,134 Accrued expenses and other liabilities 6,837 6,084 Operating lease liability, current portion 696 550 Deferred revenue, current portion 4,649 4,439 Total current liabilities 20,655 16,207 Deferred revenue, less current portion 8,659 10,989 Royalty purchase agreement 16,167 – Loan payable 14,204 14,292 Operating lease liability, less current portion 1,135 1,687 Other long-term liabilities 248 40 TOTAL LIABILITIES 61,068 43,215 STOCKHOLDERS’ EQUITY Preferred stock, $0.0001 par value per share; 10,000,000 shares authorized; none issued or outstanding at September 30, 2025 and December 31, 2024. – – Common stock, $0.0001 par value per share; 340,000,000 shares authorized; 56,464,731 and 38,194,442 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively. 6 4 Additional paid-in capital 412,512 342,780 Accumulated other comprehensive income 45 52 Accumulated deficit (368,824) (309,878)TOTAL STOCKHOLDERS’ EQUITY 43,739 32,958 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $104,807 $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 September 30, 2025 2024 Revenue: Partnership revenue $721 $803 Product revenue 140 184 Total revenue 861 987 Expenses: Cost of product revenues 49 68 Research and development 14,027 11,595 Selling, general and administrative 7,098 5,666 Total expenses 21,174 17,329 Loss from operations (20,313) (16,342)Other (expense) income: Interest (expense) income, net (515) 916 Total other (expense) income (515) 916 Net loss $(20,828) $(15,426)Net loss per share Basic and diluted $(0.40) $(0.41)Weighted-average shares used in computing net loss per share, basic and diluted 52,186,503 37,621,495 Comprehensive loss Net loss $(20,828) $(15,426)Unrealized gain on marketable securities 29 121 Comprehensive loss $(20,799) $(15,305)
– Submission of New Drug Application (NDA) for lorundrostat planned for late-2025/Q1 2026 – – Completed enrollment in Explore-OSA trial; topline results anticipated in Q1 2026 – – Conference call today at 4:30 p.m. ET – RADNOR, Pa., Nov. 10, 2025 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced financial results for the third quarter ended September 30, 2025, and provided a corporate update. “We are at an exciting point in our company’s history as we prepare for our NDA submission following pre-NDA feedback from the FDA last month. Our team has developed a fulsome data package consisting of multiple clinical trials which have demonstrated a well characterized efficacy and safety profile across distinct populations with uncontrolled and resistant hypertension. These findings for lorundrostat will provide the foundation for an NDA submission which we anticipate submitting near the end of 2025 or during the first quarter of 2026,” stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “We continue to evaluate lorundrostat’s use in prevalent comorbidities of hypertension, for which normalizing aldosterone production may result in meaningful clinical benefit. Following positive topline data from our Phase 2 Explore-CKD trial, demonstrating successful results in the OSA patient population in our Phase 2 Explore-OSA trial would continue to expand the opportunity for lorundrostat in treating hypertension patients.” Recent Clinical Highlights and Upcoming Milestones Transform-HTN Open-Label Extension Trial – The Company’s open-label extension trial enables participants to continue to receive lorundrostat while allowing the Company to gather ongoing safety and efficacy data.Explore-OSA Phase 2 Trial – Enrollment is complete and topline data is anticipated in the first quarter of 2026. The trial is evaluating the safety and efficacy of lorundrostat in the treatment of overweight or obese participants with moderate-to-severe OSA and hypertension.Strengthened Balance Sheet – On September 4, 2025, the Company completed a public equity financing for gross proceeds of approximately $287.5 million, before deducting fees and expenses. Third Quarter 2025 Financial Highlights Cash, cash equivalents and investments were $593.6 million as of September 30, 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 2028. Research and Development (R&D) expenses for the quarter ended September 30, 2025 were $31.5 million, compared to $54.0 million for the quarter ended September 30, 2024. The decrease in R&D expenses was primarily due to a decrease of $26.8 million in preclinical and clinical costs primarily impacted by the conclusion of the lorundrostat pivotal program in the second quarter of 2025, partially offset by increases of $3.2 million in higher compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses and increased stock-based compensation and $1.1 million in higher clinical supply, manufacturing, regulatory and other costs. General and Administrative (G&A) expenses were $9.7 million for the quarter ended September 30, 2025, compared to $6.1 million for the quarter ended September 30, 2024. The increase in G&A expenses was primarily due to $2.2 million in higher compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses and increased stock-based compensation, $1.3 million in higher professional fees and $0.1 million in other administrative expenses. Total other income, net was $4.2 million for the quarter ended September 30, 2025, compared to $3.8 million for the quarter ended September 30, 2024. The increase was primarily attributable to increased interest earned on investments in money market funds and U.S. treasuries as a result of higher average cash balances invested during the quarter ended September 30, 2025. Net loss was $36.9 million for the quarter ended September 30, 2025, compared to $56.3 million for the quarter ended September 30, 2024. The decrease 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 today, November 10, 2025. To access the call, please dial 1-877-704-4453 in the United States or 1-201-389-0920 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) (BP) 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 estimated annual economic burden of about $219 billion in the United States in 2019. Less than 50% of hypertension patients achieve their BP goal with currently available medications. Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 30% of all hypertensive patients. About Chronic Kidney Disease (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 (approximately 37 million) U.S. adults have CKD, and approximately 22 million people in the United States are living with both hypertension and CKD. The relationship between these conditions is tightly linked: sustained hypertension may contribute to impaired kidney function, and progressive decrease in kidney function may lead to worsening BP control. When CKD is present in patients with hypertension, the risk of cardiovascular disease and mortality rises significantly. Emerging evidence points to dysregulated aldosterone as a key driver of both diseases. Excess aldosterone promotes sodium retention, vascular inflammation, and fibrosis, contributing to both uncontrolled BP and kidney injury. Despite the availability of existing therapies, a significant proportion of patients remain uncontrolled or undertreated. Early detection and targeted interventions that address underlying mechanisms, such as aldosterone dysregulation, may offer the potential to slow CKD progression, reduce cardiovascular risk, and improve long-term outcomes. Without effective management, CKD can advance to kidney failure, requiring dialysis or transplantation. About Obstructive Sleep Apnea (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 to severe OSA is associated with increased production of aldosterone and increased nighttime BP; standard treatment with positive airway pressure is not sufficient for BP reduction. 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 uncontrolled hypertension (uHTN) or resistant hypertension (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 participants. The Company has now completed four successful clinical trials of lorundrostat supporting the efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN. The Company has completed two pivotal, registrational trials, including the Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, which support the robust, durable and clinically meaningful reductions in systolic BP by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile. About Mineralys Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky. 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 submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA); the anticipated timing of NDA submission and the FDA’s review of the same; 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 participants 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; any delays in the FDA’s review of our planned NDA submission, including as a result of a government shutdown or reductions in agency funding or personnel, 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 RelationsMelyssa WeibleElixir Health Public RelationsEmail: mweible@elixirhealthpr.com Mineralys Therapeutics, Inc.Condensed Statements of Operations(in thousands, except share and per share data)(unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2025 2024 2025 2024 Operating expenses: Research and development$31,450 $53,985 $107,607 $124,012 General and administrative 9,681 6,121 24,717 16,624 Total operating expenses 41,131 60,106 132,324 140,636 Loss from operations (41,131) (60,106) (132,324) (140,636)Interest income, net 4,195 3,774 9,908 11,779 Other income (expense) 4 (10) (1) (7)Total other income, net 4,199 3,764 9,907 11,772 Net loss$(36,932) $(56,342) $(122,417) $(128,864)Net loss per share attributable to common stockholders, basic and diluted$(0.52) $(1.13) $(1.94) $(2.68)Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted 70,594,504 49,815,186 63,133,634 48,063,638 Mineralys Therapeutics, Inc.Selected Financial InformationCondensed Balance Sheet Data(amounts in thousands)(unaudited) September 30, December 31, 2025 2024Cash, cash equivalents and investments$593,628 $198,187Total assets$599,947 $205,903Total liabilities$23,520 $14,646Total stockholders’ equity$576,427 $191,257
