ST. LOUIS, Aug. 07, 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 second quarter ended June 30, 2025.
Financial
Humacyte Announces Second Quarter 2025 Financial Results and Provides Business Update
– Total revenues of $301,000 for quarter, and $818,000 for first six months of 2025, from sales and collaborative research agreement – – 82 civilian hospitals now have VAC approval to purchase Symvess™ – – ECAT approval makes Symvess available to 35 Military Treatment Facilities and 160 U.S. Department of Veterans Affairs hospitals – – Conference call today at 8:00 am ET – DURHAM, N.C., Aug. 11, 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 second quarter ended June 30, 2025, and provided a business update. “During our second quarter of 2025, we continued to execute on our U.S. commercial launch and now have 82 civilian hospitals eligible to purchase Symvess,” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “This is a substantial increase from the five hospitals that were eligible to purchase at our last quarterly update in May. This tremendous increase is due to a combination of individual hospital and healthcare system Value Analysis Committee (VAC) approvals. In addition, our recent inclusion on the Electronic Catalog (ECAT) means that approximately 190 Military Treatment Facilities and U.S. Department of Veterans Affairs (VA) hospitals are also eligible to purchase Symvess. While we encountered some headwinds during the second quarter of 2025 due to unsubstantiated attacks by detractors, we have moved forward and seen an acceleration in VAC approvals in late June and July. Indeed, our July product sales exceeded the total sales recorded during the first half of the year. We were also pleased to achieve our first commercial sale to a U.S. military treatment facility in July, and this facility has since re-ordered the Symvess product. We have great interest in improving the medical options available to healthcare professionals treating military personnel and their families and look forward to advancing our discussions with additional Department of Defense (DOD) hospitals.” “We were also gratified to see that our V007 trial data was one of only three presentations selected for special mention by the Society of Vascular Surgery in June, and that the Society chose to highlight the strength of the results in their own announcement,” continued Dr. Niklason. “In our V007 trial, the ATEV was observed to have superior functional patency during the first year over the autologous fistula control group not only in the overall study population but in two important subgroups: women, and men with diabetes and obesity. These two groups make up more than half of the dialysis access market and are underserved by the current standard of care, representing a high unmet medical need. We look forward to publication of the results from the V007 Phase 3 clinical trial in a major peer-reviewed medical journal this year.” Second Quarter 2025 and Recent Corporate Highlights Symvess Market Launch VAC Approval Process and Sales: To date, a total of 13 VACs have approved the Symvess product. Since these VAC approvals include multi-hospital networks, 82 civilian hospitals are now eligible to purchase Symvess. Furthermore, an additional 40 VACs are currently conducting their review process. Humacyte has experienced an acceleration in VAC approvals in late June and July 2025, and July product sales of $0.3 million exceeded the sales recorded during the first half of the year. To date, 12 hospitals have ordered Symvess, with multiple facilities re-ordering additional product during the month of July.ECAT Approval: In July 2025, Symvess was granted ECAT listing approval from the U.S. Defense Logistics Agency. ECAT is an internet system that provides the DOD and other federal agencies with access to manufacturers’ and distributors’ products. The ECAT approval makes Symvess available to healthcare professionals treating military service members, veterans, and other patients receiving care at approximately 35 Military Treatment Facilities and approximately 160 VA hospitals.First Military Treatment Facility Sale: Following the ECAT approval, the first sale of Symvess to a U.S. Military Treatment Facility was completed in July. The facility is a state-of-the-art medical complex located on a major U.S. military base that provides healthcare to approximately 200,000 active-duty service personnel, retirees, and their family members. Subsequent to the initial shipment, the facility has re-ordered Symvess. We are in active discussions with additional DOD facilities that are expressing interest in purchasing Symvess. ATEV in Dialysis V007 Phase 3 Study Results in Dialysis Highlighted at Major Vascular Surgery Conference: Results from the V007 Pivotal Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV™) in arteriovenous (AV) access were presented in a plenary session at the Society for Vascular Surgery Vascular Annual Meeting (VAM25) in June 2025. The V007 clinical trial enrolled a total of 242 patients, of which 110 were described as high-risk of fistula non-maturation – either women, or men having diabetes and obesity. Among this cohort, functional patency at six months and secondary patency at 12 months were significantly higher in ATEV recipients (85.7% and 76.8%, respectively), compared with AV fistula (51.9% and 46.3%, respectively) (global p-value, p
BioCardia Reports Second Quarter 2025 Business Highlights and Financial Results
SUNNYVALE, Calif., Aug. 11, 2025 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the second quarter of 2025 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2025 with the Securities and Exchange Commission. The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights. Following management’s formal remarks, there will be a question-and-answer session. Recent Business Highlights CardiAMP® autologous cell therapy in ischemic heart failure of reduced ejection fraction (BCDA-01) Two-year results from the double-blind randomized placebo-controlled Phase 3 CardiAMP HF Trial of CardiAMP autologous minimally invasive cell therapy for the treatment of ischemic heart failure in patients with reduced ejection fraction (HFrEF) were presented as a late-breaking clinical trial at the American College of Cardiology’s Annual Scientific Sessions on March 30, 2025. For study subjects, all on stable guideline directed medical therapy, the CardiAMP HF treatment group had a lower incidence of both all cause death and non-fatal MACCE than the control group during the entire 24-month period of the CardiAMP HF study (p=0.17) and the composite endpoint of all cause death, non-fatal MACCE, and quality of life was statistically significant in the subgroup of patients with elevated NTproBNP (p =0.02).CardiAMP HF Trial data has been submitted to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and we have requested a meeting to receive advice to align with PMDA on the acceptability of the clinical data and positioning of the CardiAMP system for Japanese patients with heart failure. We anticipate an in-person consultation in the fourth quarter of 2025, the outcome of which could enable us to submit for approval of the CardiAMP system for market entry in Japan.We have reported parallel ongoing efforts towards requesting a meeting with the FDA on the approvability of the FDA Designated Breakthrough CardiAMP System based on this clinical data in the fourth quarter 2025.The confirmatory CardiAMP HF II phase 3 trial is underway in the United States, with four sites actively enrolling patients and additional sites being onboarded. This trial focuses on patients with active heart stress with a primary composite endpoint of all cause death, non-fatal MACCE, and quality of life achieved in CardiAMP HF (p=0.02). CardiAMP HF II includes using the cell population analysis at screening to define treatment doses, which enables more patients to be eligible for the therapy, and improvements to the Helix system, with the use of the FDA approved Morph DNA steerable platform. Medicare reimbursement for both treated and controlled patients under C9782 is currently $17,500, which helps offset the costs of this study and reported as a reduction in R&D expense. CardiAMP autologous cell therapy in chronic myocardial ischemic with refractory angina (BCDA-02) Results from the open-label roll-in cohort of patients having chronic myocardial ischemia with refractory angina to date have shown an average 107 second increase in exercise tolerance and an 82% average reduction in angina episodes at the primary six-month follow-up endpoint compared to before receiving the study treatment. The CardiAMP cell therapy procedure for chronic myocardial ischemia is also reimbursed by CMS under reimbursement code C9782, which covers both treated and controlled patients. The last roll-in cohort patient has reached this six-month primary endpoint, and we intend to prepare the primary results of this cohort for publication and presentation. CardiALLO allogeneic cell therapy in Ischemic Heart Failure (BCDA-03) The Investigational New Drug application (IND) for a Phase 1/2 trial to deliver our allogeneic MSC for the treatment of HFrEF follows our previous cosponsored TRIDENT and POSEIDON clinical trials enrolling 45 patients at dosages up to 100 million cells delivered with our Helix transendocardial catheter. The current trial includes a 3+3 roll-in dose escalation up to a dose of 200 million cells followed by a 30-patient randomized double-blind controlled study based on a recent IND amendment to right size the study for nondilutive funding opportunities which are under discussion. The low dose cohort of 20 million cells has been completed and there have been no treatment-emergent adverse events, arrhythmias, rejection, or allergic responses. The independent Data Safety Monitoring Board recommended that the study proceed as designed in April 2025 based on the 30-day data safety assessment from this cohort. Helix Biotherapeutic Delivery The Helix transendocardial biotherapeutic delivery system is a therapeutic-enabling platform for minimally invasive targeted delivery of biologic agents to the heart and underlies BCDA-01, 02, and 03 programs. We recently announced our intent to submit for approval of the Helix transendocardial system as a DeNovo 510(k) in the third quarter 2025. Intellectual Property The Company’s intellectual property portfolio was strengthened with the issuance of another patent this past quarter. In June, the Company announced that the that United States Patent Office has granted US patent No. 12,311,127 titled “Radial and Trans-endocardial Delivery Catheter.” The patent describes the Company’s minimally invasive interventional biotherapeutic delivery catheter systems to deliver biologic therapies to target sites in the heart. This minimally invasive delivery approach enables optimal, site-specific treatment, minimizes off-target toxicities, and avoids the need for surgical access to the heart. The allowed patent protects BioCardia’s helical needle-tipped catheter technology platform, which the scientific literature supports is the safest1 and most efficient2 approach for biotherapeutic delivery to the heart. “Heart failure remains a large, unmet need, impacting the lives of 56 million people worldwide, and we have made significant progress advancing our autologous CardiAMP cell therapy candidate intended to promote increased microvascular density and reduce fibrosis for a significant subgroup of these patients,” said BioCardia CEO Peter Altman, Ph.D. “Our active discussions on the approvability of the CardiAMP Cell Therapy System, as well the anticipated submission for approval of its dedicated Helix transendocardial biotherapeutic delivery catheter with even broader therapeutic impact have potential to be transformative for patients, physicians, and shareholders alike.” Second Quarter 2025 Financial Results: Research and development expenses increased to approximately $1.4 million for the three months ended June 2025 from approximately $0.8 million in the three months ended June 2024, and increased to approximately $2.9 million in the six months ended June 2025 from the six months ended June 2024, primarily due to closeout activities in the CardiAMP HF Trial and the beginning of enrollment in the CardiAMP HF II Trial.Selling, general and administrative expenses decreased to approximately $0.7 million in the three months ended June 2025 compared to approximately $0.9 million for the three months ended June 2024, primarily due to lower professional fees and share-based compensation expense. Selling, general and administrative expenses remained consistent at approximately $1.9 million in the six months ended June 2025, as compared to approximately $1.9 million in the six months ended June 2024.Our net loss was approximately $2.0 million for the three months ended June 2025, compared to approximately $1.6 million for the three months ended June 2024, and was approximately $4.8 million for the six months ended June 2025, compared to approximately $3.9 million for the six months ended June 2024. These increases were due primarily to the increased expenses associated with closeout activities in the CardiAMP HF Trial and the beginning of enrollment in the CardiAMP HF II Trial.Net cash used in operations for the three months ended June 2025 was approximately $1.6 million, as compared to approximately $1.3 million for the three months ended June 2024. Net cash used in operations for the six months ended June 2025 was approximately $3.3 million, as compared to approximately $2.8 million for the six months ended June 2024.Our cash balance on June 30, 2025, was approximately $980,000. During the period from July 1, 2025 to August 8, 2025, we sold an aggregate of 296,422 shares of common stock under our ATM program at an average price of $2.59 per share to total gross proceeds of $769,000. This brings our current cash balance to approximately $1.1 million and provides runway into October 2025. ANTICIPATED UPCOMING MILESTONES AND EVENTS: BCDA-01 CardiAMP Autologous Cell Therapy in Heart Failure (HF) CardiAMP HF manuscript – Q4 2025CardiAMP HF Japan PMDA Clinical Review – Q4 2025CardiAMP HF FDA meetings on approvability based on subgroup and safety – Q4 2025CardiAMP HF II Enrollment – Ongoing BCDA-02 CardiAMP Autologous Cell Therapy in Chronic Myocardial Ischemia CardiAMP CMI Top line Data Rollin Cohort – Q4 2025 BCDA-03 CardiALLO Allogeneic MSC Cell Therapy in Heart Failure CardiALLO HF Nondilutive Funding – Q1 2026 Helix Biotherapeutic Delivery System Helix biotherapeutic delivery FDA Submission for Approval – Q3 2025 About BioCardia BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLOTM allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its HelixTM biotherapeutic delivery and Morph® vascular navigation platforms. The CardiAMP Cell Therapy Trial for Heart Failure has been supported financially by the Maryland Stem Cell Research Fund and the Center for Medicare and Medicaid Services. For more information visit: www.BioCardia.com. Forward Looking Statements This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the enrollment in our clinical trials, the availability of data from our clinical trials, filings and communications with the FDA and Japan’s PMDA, product clearances, the efficacy and safety of our products and therapies, the achievement of any of the anticipated upcoming milestones, our positioning for growth or the market for our products and therapies, the expected benefits of our intellectual property, future prospects, regulatory timelines, and other statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans, the ability to enter into licensing and partnering arrangements and overall market conditions. We may find it difficult to enroll patients in our clinical trials due to many factors, some of which are outside of our control. Slower than targeted enrollment could delay completion of our clinical trials and delay or prevent the development of our therapeutic candidates. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, under the caption titled “Risk Factors BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.” 1. Raval AN and Pepine CJ. Clinical Safety Profile of Transendocardial Catheter Injection Systems: A Plea for Uniform Reporting, Cardiovasc Revasc Med, 2021.2. Mitsutake Y, Pyum WB, Rouy D, et al. Improvement of local cell delivery using Helix Transendocardial Delivery Catheter in a porcine heart, Int Heart J. 2017. BIOCARDIA, INC. Consolidated Statements of Operations (Unaudited In thousands, except share and per share amounts) Three Months endedJune 30, Six Months endedJune 30, 2025 2024 2025 2024 Revenue: Collaboration agreement revenue$— $3 $— $58 Costs and expenses: Research and development 1,368 800 2,898 2,041 Selling, general and administrative 683 852 1,879 1,941 Total costs and expenses 2,051 1,652 4,777 3,982 Operating loss (2,051) (1,649) (4,777) (3,924)Other income (expense): Total other income, net 2 3 16 11 Net loss$(2,049) $(1,646) $(4,761) $(3,913) Net loss per share, basic and diluted$(0.40) $(0.88) $(0.98) $(2.20) Weighted-average shares used in computing net loss per share, basic and diluted 5,059,736 1,877,069 4,848,922 1,776,305 BioCardia, Inc. Selected Balance Sheet Data (amounts in thousands) June 30,2025(1) December 31,2024(1) Assets: Cash and cash equivalents$980 $2,371Other current assets 219 251Property, plant and equipment and other noncurrent assets 890 1,102Total assets$2,089 $3,724Liabilities and Stockholders’ Equity (Deficit) Current liabilities$3,642 $2,321Operating lease liability – noncurrent 333 566Total stockholders’ equity (deficit) (1,886) 837Total liabilities and stockholders’ equity (deficit)$2,089 $3,724 (1) June 30, 2025 amounts are unaudited. December 31, 2024 amounts were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission on March 26, 2025. Media Contact: Miranda Peto, Investor RelationsEmail: mpeto@BioCardia.comPhone: 650-226-0120 Investor Contact: David McClung, Chief Financial OfficerEmail: investors@BioCardia.comPhone: 650-226-0120
Milestone Pharmaceuticals Reports Second Quarter 2025 Financial Results and Provides Regulatory and Corporate Update
FDA Accepted the Company’s Response to the CRL for CARDAMYST™ (etripamil) Nasal Spray; New PDUFA Target Date of December 13, 2025 Milestone Strengthens Balance Sheet to Fully Commercialize CARDAMYST if Approved Public Offering Raised Total Gross Proceeds of up to $170 Million if all Warrants are Exercised $75 Million Royalty Purchase Agreement Payment from RTW Extended Through End of 2025 MONTREAL and CHARLOTTE, N.C., Aug. 12, 2025 (GLOBE NEWSWIRE) — Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the second quarter ended June 30, 2025 and provided corporate and regulatory updates. “With the FDA’s recent acceptance of our response to the CRL, our team is energized as we work toward the potential approval of CARDAMYST in its first indication, PSVT,” said Joe Oliveto, President and Chief Executive Officer of Milestone. “In parallel to our regulatory progress, we completed an equity financing in July with high-quality investors which strengthened our balance sheet and extended our operating runway. Our goal is to make CARDAMYST quickly available to PSVT patients, should the FDA grant approval this year.” Second Quarter and Recent Program Updates Etripamil for patients with PSVT FDA accepted the Company’s response to the Complete Response Letter (CRL) for CARDAMYST™ (etripamil) Nasal Spray and set a new Prescription Drug User Fee Act (PDFUA) target date of December 13, 2025. In June, Milestone submitted to the FDA its response to a CRL for CARDAMYST, its lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT). On July 11, 2025, the Company announced the FDA accepted the response to issues raised in the CRL and assigned a new PDUFA target date of December 13, 2025. Milestone has maintained its launch infrastructure that was in place prior to the CRL and has restarted targeted pre-launch activities given the new potential approval date of CARDAMYST. Etripamil for patients with atrial fibrillation with rapid ventricular rate (AFib-RVR) Phase 3 protocol of etripamil 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 has paused initiation of enrollment in the study to prioritize resources for the preparation of the expected launch of etripamil in PSVT. Second Quarter and Recent Corporate Updates In July 2025, Milestone completed a public equity offering, raising total gross proceeds of up to $170 million, if all Series A and B warrants are exercised for cash, including immediate net proceeds of approximately $48.7 million. Milestone intends to use the proceeds from the underwritten public offering (the “Offering”), together with existing cash and cash equivalents, to fund the continued development and commercial launch of CARDAMYST in its lead indication of PSVT, as well as for working capital and other general corporate purposes. The Offering consisted of the sale and issuance of (i) 31,500,000 of its common shares (the “Shares”), accompanying Series A common warrants (the “Series A Common Warrants”) to purchase an aggregate of 31,500,000 common shares and accompanying Series B common warrants (the “Series B Common Warrants”) to purchase an aggregate of 31,500,000 common shares , at a combined public offering price of $1.50 per share and accompanying Series A Common Warrant and Series B Common Warrant and (ii) in lieu of common shares to certain investors that so choose, pre-funded warrants to purchase 3,502,335 common shares, accompanying Series A Common Warrants to purchase an aggregate of 3,502,335 common shares and accompanying Series B Common Warrants to purchase an aggregate of 3,502,335 common shares, at a combined public offering price of $1.499 per pre-funded warrant and accompanying Series A Common Warrant and Series B Common Warrant, which represented the combined public offering price for the Shares and accompanying common warrants less the $0.001 per share exercise price for each such pre-funded warrant. The net proceeds to the Company received from the Offering were approximately $48.7 million after deducting underwriting commissions and estimated offering expenses payable by the Company.Amended Royalty Agreement with RTW. Milestone extended the marketing approval deadline in its $75 million purchase and sale agreement (the “Royalty Purchase Agreement”) with existing shareholder, RTW Investments, LP, and certain of its affiliates (RTW) from September 30, 2025 to December 31, 2025. The proceeds from the Royalty Purchase Agreement are expected to fund the continued development and commercial launch of CARDAMYST in its lead indication of PSVT, following potential FDA approval and satisfaction of other customary closing conditions. Second Quarter 2025 Financial Results As of June 30, 2025, Milestone had cash, cash equivalents, and short-term investments of $43.4 million, compared to $69.7 million as of December 31, 2024. Subsequent to the end of the quarter, the company raised net proceeds of approximately $48.7 million from the Offering, as described above.There was no revenue for the second quarter ended June 30, 2025 or for the second quarter of 2024.Research and development expense for the second quarter of 2025 was $3.7 million, compared with $2.8 million for the prior year period. For the six months ended June 30, 2025, research and development expense was $8.6 million compared with $6.5 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 second quarter of 2025 was $3.8 million, compared with $5.0 million for the prior year period. For the six months ended June 30, 2025, general and administrative expense was $8.9 million, compared with the $9.0 million for the prior year period. The decrease between the quarters is primarily due to a decrease in legal fees, professional fees, and personnel costs.Commercial expense for the second quarter of 2025 was $5.1 million, compared with $1.8 million for the prior year period. For the six months ended June 30, 2025, commercial expense was $15.5 million compared with $4.7 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. As a result of the CRL, Milestone temporarily paused the ramping of operational expenditures related to launch, but has maintained the capability to launch quickly, pending approval of CARDAMYST by the FDA.For the second quarter of 2025, net loss was $13.0 million, compared to $9.4 million for the prior year period. For the six months ended June 30, 2025, Milestone’s net loss was $33.7 million, compared to $19.7 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 ended June 30, 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 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) June 30, 2025 December 31, 2024Assets Current assets Cash and cash equivalents$42,499 $25,314 Short-term investments918 44,381 Research and development tax credits receivable1,079 901 Prepaid expenses748 1,840 Other receivables924 1,490 Total current assets46,168 73,926 Operating lease right-of-use assets1,090 1,376 Property and equipment159 197 Total assets$47,417 $75,499 Liabilities, and Shareholders’ (Deficit) Equity Current liabilities Accounts payable and accrued liabilities$8,768 $7,555 Operating lease liabilities515 571 Total current liabilities9,283 8,126 Operating lease liabilities, net of current portion641 874 Senior secured convertible notes55,238 53,352 Total liabilities65,162 62,352 Shareholders’ (Deficit) Equity Common shares, no par value, unlimited shares authorized, 53,494,261 shares issued and outstanding as of June 30, 2025, 53,353,984 shares issued and outstanding as of December 31, 2024288,263 288,048 Pre-funded warrants – 12,910,590 issued and outstanding as of June 30, 2025 and 12,910,590 as of December 31, 202453,076 53,076 Additional paid-in capital42,188 39,568 Accumulated deficit(401,272) (367,545) Total shareholders’ (deficit) equity(17,745) 13,147 Total liabilities and shareholders’ equity$47,417 $75,499 Milestone Pharmaceuticals Inc.Condensed Consolidated Statements of Loss (Unaudited)(in thousands of US dollars, except share and per share data) Three months ended June 30, Six months ended June 30, 2025 2024 2025 2024 Revenue$— $— $— $— Operating expenses Research and development, net of tax credits 3,669 2,815 8,647 6,454 General and administrative 3,759 5,046 8,926 8,999 Commercial 5,103 1,801 15,481 4,685 Loss from operations (12,531) (9,662) (33,054) (20,138) Interest income 516 1,186 1,213 2,180 Interest expense (951) (887) (1,886) (1,759) Net loss and comprehensive loss$(12,966) $(9,363) $(33,727) $(19,717) Weighted average number of shares and pre-funded warrants outstanding, basic and diluted 66,380,118 66,165,461 66,333,024 58,160,286 Net loss per share, basic and diluted$(0.20) $(0.14) $(0.51) $(0.34)
Orchestra BioMed Reports Second Quarter 2025 Financial Results and Highlights Recent Business Updates
Secured over $111 million in proceeds and committed capital following completion of strategic transactions and concurrent public and private equity offerings, led by over $71 million in committed capital from Medtronic and LigandAchieved multiple FDA regulatory milestones: Breakthrough Device Designation for AVIM therapy; approval for expanded BACKBEAT study enrollment criteria, and IDE approval for a U.S. pivotal Virtue SAB trial versus commercially available paclitaxel-coated balloon NEW HOPE, Pa., Aug. 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 second quarter ended June 30, 2025, and provided a business update highlighting recent financial and regulatory milestones. Q2 2025 and Recent Business Highlights: Completed multiple strategic transactions and concurrent public and private equity offerings totaling an expected $111.2 million in gross proceeds to support continued advancement of the Company’s late-stage atrioventricular interval modulation (“AVIM”) therapy and Virtue Sirolimus AngioInfusion Balloon (“SAB”) clinical programs. Gross proceeds are comprised of: $55 million received or to be received by May 1, 2026, subject to certain conditions, from royalty-based, non-dilutive investments from Ligand Pharmaceuticals Incorporated (Nasdaq: LGND, “Ligand”) and Medtronic, plc (NYSE: MDT, “Medtronic”) Ligand committed $35 million in exchange for a tiered revenue interest in Orchestra BioMed’s future royalties from AVIM therapy and Virtue SABMedtronic committed $20 million in exchange for a secured subordinated promissory note convertible to capped prepaid revenue share $56.2 million received from a $40 million underwritten public offering of common stock and prefunded warrants and $11.2 million and $5 million received from private placements of common stock to Medtronic and Ligand, respectivelyProceeds expected to extend cash runway into the second half of 2027, supporting potentially significant value-creating catalysts, including: BACKBEAT study enrollment completion in mid-2026BACKBEAT study primary endpoint dataSubstantial enrollment of the Virtue Trial Medtronic and Orchestra BioMed expanded strategic collaboration to provide pathway for future development of AVIM therapy-enabled leadless pacemakers.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, marking a major regulatory validation of the therapy’s potential to improve hypertensive heart disease outcomes.FDA-approved updated BACKBEAT study protocol now being implemented, broadening patient enrollment criteria for a more than 24-fold increase in the potentially eligible patient pool; full implementation to be completed in Q4 2025.FDA Investigational Device Exemption (“IDE”) Approval received for the Virtue SAB U.S. pivotal trial, a randomized head-to-head study comparing Virtue SAB with the commercially available AGENT™ 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, with conclusion of formal mediation process expected in Q3 2025. Intellectual Property Expansion continued with AVIM therapy patent estate reaching 137 issued patents worldwide, with recent additions bolstering coverage for both hypertension and heart failure indications. Chairman and Chief Executive Officer (“CEO”) Commentary from David Hochman: Mr. Hochman stated: “The successful completion of strategic financing transactions with Medtronic and Ligand, along with closing our first underwritten public offering are expected to give us up to $111 million in new capital to support execution of both AVIM therapy and Virtue SAB pivotal clinical studies. Our entire organization is focused on our mission to bring these high-impact, innovative, device-based therapies to market.” Mr. Hochman continued: “We were also proud to have achieved multiple key regulatory milestones for both AVIM therapy and Virtue SAB in the second quarter. The FDA Breakthrough Device Designation awarded to AVIM therapy for the treatment of uncontrolled hypertension in patients with increased cardiovascular risk has potentially significant implications to future regulatory submissions and opens up potential pathways for enhanced reimbursement for AVIM therapy-enabled devices. The FDA also approved an important update to the BACKBEAT study protocol that we are now rolling out to study centers that significantly expands eligibility criteria for enrollment and supports our enrollment completion objectives for next year. Finally, FDA approval of the updated IDE for our head-to-head pivotal trial comparing Virtue SAB to commercially available AGENT paclitaxel-coated balloon marks another significant regulatory milestone. These achievements will help us in our continued efforts to reshape clinical standards of care in both hypertensive heart disease and atherosclerotic artery disease.” Financial Results for the Second Quarter Ended June 30, 2025 Cash and cash equivalents and Marketable securities totaled $33.9 million as of June 30, 2025. Combined with net proceeds received from recent financing transactions, estimated Cash and cash equivalents and Marketable securities position was $101 million as of August 12, 2025. The Company has commitments from Ligand and Medtronic to receive a combined $35 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 $15.6 million during the second quarter of 2025, compared with $10.3 million for the second quarter in 2024, with the primary driver being increased research and development costs during the second quarter of 2025.Revenue for the second quarter of 2025 was $0.8 million, compared with $0.8 million for the second quarter in 2024.Research and development expenses for the second quarter of 2025 were $13.9 million, compared with $11.1 million for the second 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 second quarter of 2025 were $6.3 million, compared with $6.5 million for the second quarter of 2024. The decrease was primarily due to a decrease in professional fees.Net loss for the second quarter of 2025 was $19.4 million, or $0.50 per share, compared with a net loss of $16.0 million, or $0.45 per share, for the second quarter of 2024. Net loss for the second quarter of 2025 included $3.2 million in non-cash stock-based compensation expense as compared to $2.8 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 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 AGENT™ 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, including the timing of completion of enrollment in the BACKBEAT study and the timing of initiation of the Virtue Trial, the receipt of committed capital, the Company’s expected cash runway, the date of completion of the formal mediation with Terumo, the potential benefits of BDD, 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) June 30, December 31, 2025 2024ASSETS CURRENT ASSETS: Cash and cash equivalents $18,749 $22,261 Marketable securities 15,175 44,551 Accounts receivable, net 83 92 Inventory 185 173 Prepaid expenses and other current assets 1,690 2,094 Total current assets 35,882 69,171 Property and equipment, net 1,366 1,384 Right-of-use assets 1,806 2,103 Strategic investments 2,495 2,495 Deposits and other assets 1,276 1,020 TOTAL ASSETS $42,825 $76,173 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Accounts payable $5,308 $5,134 Accrued expenses and other liabilities 6,650 6,084 Operating lease liability, current portion 642 550 Deferred revenue, current portion 4,461 4,439 Total current liabilities 17,061 16,207 Deferred revenue, less current portion 9,568 10,989 Loan payable 14,384 14,292 Operating lease liability, less current portion 1,328 1,687 Other long-term liabilities 189 40 TOTAL LIABILITIES 42,530 43,215 STOCKHOLDERS’ EQUITY Preferred stock, $0.0001 par value per share; 10,000,000 shares authorized; noneissued or outstanding at June 30, 2025 and December 31, 2024. — — Common stock, $0.0001 par value per share; 340,000,000 shares authorized;38,643,553 and 38,194,442 shares issued and outstanding as of June 30, 2025 andDecember 31, 2024, respectively. 4 4 Additional paid-in capital 348,271 342,780 Accumulated other comprehensive income 16 52 Accumulated deficit (347,996) (309,878)TOTAL STOCKHOLDERS’ EQUITY 295 32,958 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $42,825 $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 June 30, 2025 2024Revenue: Partnership revenue $667 $628 Product revenue 169 150 Total revenue 836 778 Expenses: Cost of product revenues 46 44 Research and development 13,853 11,126 Selling, general and administrative 6,264 6,467 Total expenses 20,163 17,637 Loss from operations (19,327) (16,859)Other (expense) income: Interest (expense) income, net (36) 902 Loss on fair value of strategic investments – (23)Total other (expense) income (36) 879 Net loss $(19,363) $(15,980)Net loss per share Basic and diluted $(0.50) $(0.45)Weighted-average shares used in computing net loss per share, basicand diluted 38,392,716 35,800,273 Comprehensive loss Net loss $(19,363) $(15,980)Unrealized loss on marketable securities (21) (15)Comprehensive loss $(19,384) $(15,995)
Reprieve Cardiovascular Secures $61 Million Financing and Enrolls First Patient in Pivotal Study
— Series B fundraise led by Deerfield Management enables scaling of pivotal clinical trial and commercial readiness activities for Reprieve® System – First patient enrolled in FASTR II study by Washington University School of Medicine in St. Louis MILFORD, Mass., August 13, 2025 – Reprieve Cardiovascular, Inc., a clinical-stage company pioneering […]
Mineralys Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update
– Presented and published the positive results from both the Launch-HTN and Advance-HTN pivotal trials at scientific meetings and in JAMA and NEJM – – Pre-NDA meeting scheduled to take place in 4Q 2025 – – Explore-CKD Phase 2 trial successfully achieved statistical significance in reduction of systolic BP and UACR, and demonstrated a favorable safety profile – – Explore-OSA Phase 2 trial in OSA participants with hypertension is ongoing; topline results anticipated in 1H 2026 – – Conference call today at 4:30 p.m. ET – RADNOR, Pa., Aug. 12, 2025 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced financial results for the second quarter ended June 30, 2025, and provided a corporate update. “We continue to lead the way in the development of ASIs for the treatment of hypertension and related cardiorenal conditions. In the first half of 2025, we announced positive results from three clinical trials evaluating lorundrostat for the treatment of participants with uncontrolled or resistant hypertension. These data further support our belief that lorundrostat has significant potential to be a leading new therapy to control hypertension and reduce cardiovascular risk,” stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “The results from our clinical program have positioned us to move ahead with our NDA strategy, and we have scheduled a pre-NDA meeting with the FDA to take place in the fourth quarter of 2025.” 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 participants with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) as add-on therapy, who fail to achieve blood pressure (BP) control on their existing medications. Published the positive results from the Launch-HTN trial in the June 30, 2025 issue of the Journal of the American Medical Association (JAMA) in a manuscript titled, “Lorundrostat in Participants with Uncontrolled and Treatment-Resistant Hypertension.”Presented the positive results from the Launch-HTN trial as a late-breaking presentation at the 2025 European Society of Hypertension Meeting on Hypertension and Cardiovascular Protection in Milan, Italy. Pivotal Advance-HTN Trial –The trial met its primary endpoints in evaluating the efficacy and safety of lorundrostat for the treatment of confirmed uHTN or rHTN. 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. Presented detailed results from the Advance-HTN trial in a late-breaking presentation at the American College of Cardiology’s ACC.25 meeting.Published the positive results from the Advance-HTN trial in the April 23, 2025 issue of the New England Journal of Medicine in a manuscript titled, “Lorundrostat Efficacy and Safety in Patients with Uncontrolled Hypertension.” Explore-CKD Phase 2 Trial – Announced positive topline data from the Phase 2 Explore-CKD trial evaluating the safety and efficacy of 25 mg of lorundrostat in participants with hypertension, reduced kidney function and albuminuria. The crossover trial met its primary endpoint and demonstrated a favorable safety and tolerability profile. The trial reported that the lorundrostat 25 mg dose achieved a 9.25 mmHg reduction in systolic BP, and a 7.5 mmHg placebo-adjusted reduction (p-value = 0.0024), as assessed by automated office blood pressure (AOBP) at week four. In addition, the lorundrostat 25 mg dose achieved a reduction in spot urine albumin-to-creatinine ratio (UACR) of 30.51% from baseline, and a 25.6% placebo-adjusted reduction (p-value = 0.0015) at week four.Transform-HTN Open-Label Extension Trial – The Company’s open-label extension trial that allows participants to continue to receive lorundrostat and the Company to obtain additional safety and efficacy data is ongoing.Explore-OSA Phase 2 Trial – The trial will evaluate the safety and efficacy of lorundrostat in the treatment of overweight and obese participants with moderate-to-severe OSA and uHTN or rHTN. The Company anticipates reporting topline results from Explore-OSA in 1H 2026. Second Quarter 2025 Financial Highlights Cash, cash equivalents and investments were $324.9 million as of June 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 2027. Research and Development (R&D) expenses for the quarter ended June 30, 2025 were $38.3 million, compared to $39.3 million for the quarter ended June 30, 2024. The decrease in R&D expenses was primarily due to a decrease of $4.5 million in preclinical and clinical costs driven by the conclusion of the lorundrostat pivotal program in the second quarter of 2025, partially offset by increases of $2.7 million in higher compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses and increased stock-based compensation and $0.8 million in higher clinical supply, manufacturing regulatory and other costs. General and Administrative (G&A) expenses were $8.5 million for the quarter ended June 30, 2025, compared to $5.9 million for the quarter ended June 30, 2024. The increase in G&A expenses was primarily due to $1.9 million in higher compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses and increased stock-based compensation, $0.6 million in higher professional fees and $0.1 million in other administrative expenses. Total other income, net was $3.5 million for the quarter ended June 30, 2025, compared to $4.2 million for the quarter ended June 30, 2024. The decrease was primarily attributable to decreased interest earned on investments in money market funds and U.S. treasuries as a result of lower average cash balances invested during the quarter ended June 30, 2025. Net loss was $43.3 million for the quarter ended June 30, 2025, compared to $41.0 million for the quarter ended June 30, 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 today, August 12, 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 BP (or hypertension) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the United States.1 In 2022, more than 685,000 deaths in the United States included hypertension as a primary or contributing cause.2 Hypertension and related health issues resulted in an estimated annual economic burden of about $219 billion in the United States in 2019.3 Less than 50% of hypertension patients achieve their BP goal with currently available medications.4 Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 30% of all hypertensive patients.5 About Chronic Kidney Disease Chronic kidney disease (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.6 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.7 When CKD is present in patients with hypertension, the risk of cardiovascular disease and mortality rises significantly.8 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.9,10 Despite the availability of existing therapies, a significant proportion of patients remain uncontrolled or undertreated.4 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.9 Without effective management, CKD can advance to kidney failure, requiring dialysis or transplantation.11 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 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 a potential pre-NDA meeting with the 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 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; 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. References 1CDC. Facts About Hypertension. Centers for Disease Control and Prevention. Updated September 27, 2023. Accessed June 2025. 2CDC. Underlying Cause of Death, 1999–2022 Results. CDC WONDER Online Database. Accessed June 2025.3Centers for Disease Control and Prevention. Health and Economic Benefits of High Blood Pressure Interventions. National Center for Chronic Disease Prevention and Health Promotion. Updated November 20, 2023. Accessed June 2025.4Carey RM, et al. Resistant Hypertension: Detection, Evaluation, and Management: A Scientific Statement from the AHA. Hypertension. 2018;72(5):e53-e90. 5Brown JM, et al. Primary Aldosteronism and the Pathogenesis of Hypertension. Physiol Rev. 2018;98(1):103-137. 6National Kidney Foundation. High Blood Pressure and Chronic Kidney Disease | National Kidney Foundation. Accessed June 2025.7Ku E, Lee BJ, Wei J, Weir MR. Hypertension in CKD: Core Curriculum 2019. Am J Kidney Dis. 2019;74(1):120-131.8Tonelli M, et al. Chronic kidney disease and mortality risk: a systematic review. J Am Soc Nephrol. 2006;17(7):2034-2047.9Bomback AS, et al. Potential of aldosterone synthase inhibition in CKD and hypertension. Kidney Int. 2022;102(1):18-27.10Luther JM. Effects of aldosterone on the kidney and cardiovascular system. Nat Rev Nephrol. 2014;10(6):308-320.11CDC. Chronic Kidney Disease in the United States, 2021. Accessed June 2025. 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 Six Months Ended June 30, June 30, 2025 2024 2025 2024 Operating expenses: Research and development$38,278 $39,273 $76,157 $70,027 General and administrative 8,468 5,895 15,036 10,503 Total operating expenses 46,746 45,168 91,193 80,530 Loss from operations (46,746) (45,168) (91,193) (80,530)Interest income, net 3,474 4,152 5,713 8,005 Other income (expense) (2) 2 (5) 3 Total other income, net 3,472 4,154 5,708 8,008 Net loss$(43,274) $(41,014) $(85,485) $(72,522)Net loss per share attributable to common stockholders, basic and diluted$(0.66) $(0.83) $(1.44) $(1.54)Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted 65,451,297 49,356,287 59,341,368 47,178,288 Mineralys Therapeutics, Inc.Selected Financial InformationCondensed Balance Sheet Data(amounts in thousands)(unaudited) June 30, December 31, 2025 2024 Cash, cash equivalents and investments$324,916 $198,187 Total assets$335,724 $205,903 Total liabilities$22,173 $14,646 Total stockholders’ equity$313,551 $191,257
Heart Failure Society of America and American Society for Preventive Cardiology Joint Statement Calls for a Shift in Heart Failure Prevention and Care
WASHINGTON, Aug. 13, 2025 /PRNewswire/ — Heart failure affects more than 6 million Americans and is projected to reach over 11 million by 2050. Despite therapeutic advances, nearly 1 in 4 patients are readmitted within 30 days of discharge and 1 in 5 dies within a year. The economic…
BioCardia and CART-Tech Announce Exclusive Partnership to Develop and Commercialize Heart3D™ Fusion Imaging for Interventional Cardiology
SUNNYVALE, Calif. and UTRECHT, Netherlands, Aug. 13, 2025 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, and CART-Tech, B.V., a provider of vendor independent platform technology for augmented fluoroscopy during cardiac interventions, today announce that they have entered into an exclusive development and commercialization agreement for Heart3D™ Fusion Imaging. The Heart3D system is expected to enhance two-dimensional x-ray images used for cardiac biotherapeutic delivery and biopsy procedures by fusing these images with annotated pre-procedure three-dimensional anatomical heart models created from gold standard MRI and CT images.
Conformal Medical Closes $32 Million Series D Extension to Advance its Next-Generation Left Atrial Appendage Occlusion Technology
New partner reinforces confidence in the company’s progress and future potential. NASHUA, N.H., Aug. 12, 2025 /PRNewswire/ — Conformal Medical, Inc., a medical device company developing next-generation left atrial appendage occlusion (LAAO) technology, announced the successful closing of…
