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SeaStar Medical Reports Second Quarter 2026 Financial Results and Provides Business Updates

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Added 3 top-rated children’s hospitals to QUELIMMUNE® pediatric acute kidney injury (AKI) customer base, increasing net revenue 82% versus second quarter 2025 Advanced enrollment in the NEUTRALIZE-AKI pivotal clinical trial in adult patients with AKI Obtained ICD-10-PCS codes to enable standardized inpatient hospital billing for its selective cytopheretic device (SCD) therapy, including QUELIMMUNE Webcast today at 4:30 pm Eastern Time DENVER, Aug. 12, 2026 (GLOBE NEWSWIRE) — SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life, announced today financial results for the three months ended June 30, 2026, and provided business updates on key initiatives. “The enthusiasm for the use of our QUELIMMUNE therapy is resonating broadly throughout the pediatric critical care community,” said Eric Schlorff, CEO of SeaStar Medical. “We believe our continued QUELIMMUNE revenue growth bodes well for our future potential opportunity in the adult AKI market that is 50 times larger than the current pediatric market in the U.S.” Mr. Schlorff continued, “We are keenly focused on achieving our enrollment target of 339 adult AKI patients in the NEUTRALIZE-AKI trial, and we are working with the FDA on our modular Premarket Approval (PMA) application for our SCD therapy as an organ-sparing and life-saving treatment for the adult patient population. With strong gross margins for QUELIMMUNE and universal ICD-10-PCS codes already established for our SCD therapies, we believe this first-in-class therapy for the treatment of adult patients with AKI has clear potential to both save lives and create significant shareholder value, should we obtain FDA approval.”   Key Business Highlights SeaStar Medical’s achievements since the beginning of the second quarter of 2026 include the following: Expanded the use of QUELIMMUNE (SCD-PED) therapy for ultra-rare pediatric AKI, adding 3 new customers from top-rated children’s hospitals, bringing the total customer base to 20 and building increased depth in customer orders. This led to second quarter 2026 net revenue of $0.6 million for QUELIMMUNE product sales, an increase of 82% versus the second quarter of 2025.Advanced enrollment in the NEUTRALIZE-AKI pivotal clinical trial evaluating the SCD therapy as a potential treatment of adult patients with AKI in the ICU receiving continuous renal replacement therapy. The trial has enrolled 223 of 339 patients to date. Completion of enrollment is anticipated around year end or into the first quarter of 2027, which would enable a PMA application to the FDA near the end of 2027, pending a positive outcome of the trial.Received from the Centers for Medicare & Medicaid Services (CMS) dedicated International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) codes. These codes enable administrative, billing, and statistical reporting for the use of SeaStar Medical’s SCD therapy in patients with AKI requiring renal replacement therapy in the inpatient hospital setting. The new ICD-10-PCS codes are expected to take effect on October 1, 2026.Sponsored and participated in the KidneyBee Summit 2026. The Summit, which occurs annually, is a highly specialized, interdisciplinary conference that brings together nurses, advanced practice providers, and physicians from across the country. Its core importance stems from tackling the exact systemic failures that leave pediatric kidney failure under-recognized.Assembled leading experts in the treatment of pediatric AKI to speak at the SeaStar Medical educational webinar, “Rethinking Pediatric Sepsis-Associated AKI,” that brought together practicing pediatric nephrologists, critical care physicians, advanced practice providers, nurses, and critical care teams to learn more about pediatric sepsis-associated AKI and the use of the QUELIMMUNE therapy.    Financial Results for the Second Quarter 2026 Net revenue for the three months ended June 30, 2026, was approximately $0.6 million reflecting increased demand for the QUELIMMUNE therapy. This compared to net revenue of approximately $0.3 million for the three months ended June 30, 2025. Cost of goods sold for the three months ended June 30, 2026, and 2025, was $54 thousand and $27 thousand reflecting gross margins of 91% and 92% for the three months ended June 30, 2026, and 2025, respectively. Research and development expenses for the three months ended June 30, 2026, and 2025, were $2.5 million and $1.0 million, respectively. The increase in research and development expenses was primarily driven by increased clinical trial expenses and personnel costs.   General and administrative expenses for the three months ended June 30, 2026, and 2025, were approximately $1.8 million and $1.0 million, respectively. The increase in general and administrative expenses was the result of an increase in compensation costs, legal and professional fees, and certain Securities and Exchange Commission (SEC) related expenses. Other income (net) was $0.1 million for the three months ended June 30, 2026, compared to other expense (net) of $0.2 million for the three months ended June 30, 2025. The change was primarily related to a reduction in financing fees and increased interest income. Net loss for the three months ended June 30, 2026, was approximately $3.7 million, or $0.91 per share on approximately 4.1 million weighted-average shares outstanding. This compares with a net loss of approximately $2.0 million, or $1.77 per share, on approximately 1.1 million weighted-average shares outstanding for the three months ended June 30, 2025. Cash at June 30, 2026, was $7.0 million, compared to $12.0 million at December 31, 2025. SeaStar Medical Second Quarter Financial Results Conference CallDate/Time:Wednesday, August 12, 2026, at 4:30 p.m. ET / 2:30 p.m. MTWebcast:The live webcast and replay can be found here.Register for the call:Preregistration is required to attend the live call and can be accessed here. A pin code and dial in number will be provided with registration. A replay of the call will be available after 7:30 p.m. ET and can be accessed here.  About QUELIMMUNE The QUELIMMUNE® (SCD-PED) therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are on antibiotics and being treated in the ICU with RRT. It was approved in February 2024 under a Humanitarian Device Exemption application. Data from two clinical trials of the QUELIMMUNE therapy, published in Kidney Medicine, showed a 77% survival rate in patient treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data in this patient population. No dialysis was required for survivors, and 87.5% of survivors had normal kidney function at Day 60 after ICU discharge. In February 2026, data published in the prestigious, peer-reviewed journal, Pediatric Nephrology, highlighted the early experience from the QUELIMMUNE SAVE Registry, a post-approval surveillance registry, evaluating the role of the QUELIMMUNE therapy in the treatment of critically ill pediatric patients with life-threatening Acute Kidney Injury (AKI) and sepsis requiring renal replacement therapy. Observations from the first 21 pediatric patients with AKI and sepsis requiring renal replacement therapy showed no device-related adverse events or infections and no reports of immunosuppressive effects by the device. In addition, preliminary outcomes analyses show a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90. These new data are on track to validate a 50% reduction in patient mortality at 60 days compared to historical data, similar to what was observed in the registration study reported in Kidney Medicine. The patented technology behind QUELIMMUNE is known as the Selective Cytopheretic Device (SCD) therapy and has broad applications for treating the destructive hyperinflammation that shuts down organ function and causes loss of life. About the SeaStar Medical Selective Cytopheretic Device (SCD) Therapy The SCD therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body. The SCD therapy is designed for broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing patients who today have no FDA-approved options for treating their disease. Unlike pathogen removal and other blood-purification tools, the SCD therapy is integrated with an existing continuous RRT hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery, eliminate the need for future continuous RRT, including dialysis, and prevent loss of life.   About NEUTRALIZE-AKI Pivotal Trial The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating the safety and efficacy of the SCD therapy in 339 adults with AKI in the ICU receiving continuous RRT. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to continuous RRT as the standard of care, compared with the control group receiving only continuous RRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.  About Acute Kidney Injury (AKI) and Hyperinflammation  AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as severe infections or other septic conditions, severe trauma, surgery, and organ failures. AKI can cause destructive hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from this destructive hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, these patients may face complications including chronic kidney disease or end-stage renal disease (ESRD) requiring dialysis. Extreme hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation. About SeaStar Medical SeaStar Medical is a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life. SeaStar Medical’s first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA approved product for the ultra-rare condition of life-threatening Acute Kidney Injury (AKI) due to sepsis or a septic condition requiring renal replacement therapy (RRT) in critically ill pediatric patients. SeaStar Medical’s Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for six therapeutic indications by the FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch. The company is currently conducting the NEUTRALIZE-AKI pivotal clinical trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy, a life-threatening condition with no effective treatment options that impacts over 200,000 adults in the U.S. annually. For more information visit www.seastarmedical.com or visit us on LinkedIn or X. Forward-Looking Statements This press release contains certain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1955. These forward-looking statements include, without limitation, SeaStar Medical’s expectations with respect our future potential opportunity in the adult AKI market; the size of the adult AKI market compared to the pediatric market; commercial acceptance of QUELIMMUNE; the ability of SCD to treat patients with AKI and other diseases; ; the anticipated timing of regulatory submissions; the ability to meet our enrollment targets; the ability to create shareholder value; the expected regulatory approval process and timeline for commercialization; and the ability of SeaStar Medical to meet the expected timeline. Words such as “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside SeaStar Medical’s control and are difficult to predict. Factors that may cause actual future events to differ materially from the expected results include, but are not limited to: (i) the risk that SeaStar Medical may not be able to obtain regulatory approval of its SCD product candidates; (ii) the risk that SeaStar Medical may not be able to raise sufficient capital to fund its operations, including current or future clinical trials; (iii) the risk that SeaStar Medical and its current and future collaborators are unable to successfully develop and commercialize its products or services, or experience significant delays in doing so, including failure to achieve approval of its products by applicable federal and state regulators, (iv) the risk that SeaStar Medical may never achieve or sustain profitability; (v) the risk that SeaStar Medical may not be able to secure additional financing on acceptable terms; (vi) the risk that third-party suppliers and manufacturers are not able to fully and timely meet their obligations, (vii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical’s products and services, (viii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (ix) other risks and uncertainties indicated from time to time in SeaStar Medical’s Annual Report on Form 10-K, including those under the “Risk Factors” section therein and in SeaStar Medical’s other filings with the SEC. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SeaStar Medical assumes no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.  Contact:  IR@SEASTARMED.COM SeaStar Medical Holding CorporationCondensed Consolidated Balance Sheets(in thousands, except for share and per-share amounts)   June 30,2026  December 31, 2025   (unaudited)     ASSETS Current assets        Cash $6,959  $11,980 Accounts receivable, net of allowance for credit losses of $2 and $3, respectively  208   237 Inventory  77   66 Prepaid expenses  984   1,297 Total current assets  8,228   13,580 Other assets  421   578 Total assets $8,649  $14,158          LIABILITIES AND STOCKHOLDERS’ EQUITY/(DEFICIT) Current liabilities        Accounts payable $750   948 Accrued expenses  3,468   2,268 Notes payable, net of deferred financing costs  134   525 Liability classified warrants  1   1 Total current liabilities  4,353   3,742 Total liabilities  4,353   3,742          Commitments and contingencies (Note 10)                 Stockholders’ equity        Preferred stock – $0.0001 par value, 10,000,000 shares authorized at June 30, 2026 and December 31, 2025; no shares issued and outstanding at June 30, 2026 and December 31, 2025  —   — Common stock – $0.0001 par value per share; 425,000,000 and 450,000,000 shares authorized at June 30, 2026 and December 31, 2025, respectively; 4,259,842 and 3,844,613 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively  4   4 Additional paid-in capital  163,257   162,126 Accumulated deficit  (158,965)  (151,714)Total stockholders’ equity  4,296   10,416 Total liabilities and stockholders’ equity $8,649  $14,158  SeaStar Medical Holding CorporationCondensed Consolidated Statements of Operations(unaudited)(in thousands, except for share and per-share amounts)   Three Months Ended June 30,  Six Months Ended June 30,   2026  2025  2026  2025                  Net revenue $615  $338  $1,110  $631 Cost of goods sold  54   27   100   27 Gross profit  561   311   1,010   604 Operating expenses                Research and development  2,520   1,037   4,864   3,468 General and administrative  1,832   1,030   3,540   2,716 Total operating expenses  4,352   2,067   8,404   6,184 Loss from operations  (3,791)  (1,756)  (7,394)  (5,580)Other income (expense)                Interest income  69   45   160   93 Interest expense  (8)  (9)  (14)  (18)Other financing costs  —   (298)  —   (298)Change in fair value of warrants liability  —   16   —   32 Total other income (expense), net  61   (246)  146   (191)Loss before provision for income taxes  (3,730)  (2,002)  (7,248)  (5,771)Provision for income taxes  —   —   3   3 Net loss $(3,730) $(2,002) $(7,251) $(5,774)Net loss per share of common stock, basic and diluted $(0.91) $(1.77) $(1.81) $(5.78)Weighted-average shares outstanding, basic and diluted  4,084,283   1,132,952   4,001,770   998,122  SeaStar Medical Holding CorporationCondensed Consolidated Statements of Cash Flows(unaudited)(in thousands)   Six Months Ended June 30,   2026  2025          Cash flows from operating activities        Net loss $(7,251) $(5,774)Adjustments to reconcile net loss to net cash used in operating activities        Amortization of deferred financing costs  14   18 Change in fair value of liability classified warrants  —   (32)Shares issued for the standby equity purchase agreement commitment fee  —   298 Stock-based compensation  (8)  264 Change in operating assets and liabilities        Accounts receivables  29   (105)Inventory  (11)  (77)Prepaid expenses  313   784 Other assets  157   156 Accounts payable  (198)  112 Accrued expenses  1,200   (1,305)Net cash used in operating activities  (5,755)  (5,661)         Cash flows from financing activities        Proceeds from issuance of shares, net of offering costs  1,139   5,154 Proceeds from exercise warrants  —   2 Proceeds of pre-funded warrants  —   5,580 Payment of notes payable  (405)  (592)Net cash provided by financing activities  734   10,144 Net increase (decrease) in cash  (5,021)  4,483 Cash, beginning of period  11,980   1,819 Cash, end of period $6,959  $6,302           QUELIMMUNE is a registered trademark of SeaStar Medical Holding Corporation.

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Conavi Medical Corp. Announces Closing of $10M Public Offering

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NOT FOR DISTRIBUTION TO U.S. NEWS WIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES TORONTO, Aug. 12, 2026 (GLOBE NEWSWIRE) — Conavi Medical Corp. (TSXV: CNVI) (“Conavi” or the “Company”), a commercial stage medical device company focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures, is pleased to announce that it has closed its previously announced equity offering for aggregate gross proceeds of $10 million (the “Offering”). “This financing provides Conavi with the capital to execute the next important phase of our U.S. commercialization strategy,” said Thomas Looby, Chief Executive Officer of Conavi. “With our FDA-cleared hybrid IVUS-OCT imaging system, our focus is now on placing systems in U.S. hospitals, supporting initial clinical adoption and building the foundation for broader commercialization. We are grateful for the strong support of our new and existing investors and their confidence in Conavi as we advance this next stage of our growth.” The Company intends to use the net proceeds from the Offering to complete a limited market release in the United States of the Company’s Novasight Hybrid system. The Company also intends to use the net proceeds for working capital and other general corporate purposes. Bloom Burton Securities Inc. acted on behalf of a syndicate of agents in connection with the Offering (collectively, the “Agents”). Under the Offering, subscribers either purchased common shares at $0.20 per common share (the “Common Shares”) or pre-funded common share purchase warrants for $0.19999 per pre-funded common share purchase warrant (“Pre-Funded Warrants” and, together with the Common Shares, the “Securities”). Investors purchased a total of 50,000,775 Securities (consisting of 34,500,775 Common Shares and 15,500,000 Pre-Funded Warrants) for gross proceeds of $10 million. Each Pre-Funded Warrant issued in lieu of a Common Share at the election of a subscriber entitles the holder thereof to acquire one Common Share at an exercise price of $0.00001 per Common Share. The Pre-Funded Warrants will not expire. In Canada, the Securities purchased pursuant to the Offering were qualified for sale by way of a short form prospectus dated July 29, 2026, which was filed in British Columbia, Alberta and Ontario. The Securities were also purchased by way of private placement in the United States, pursuant to exemptions from the registration requirements under the U.S. Securities Act of 1933 (the “U.S. Securities Act”), and pursuant to all applicable U.S. state securities laws. In addition, the Securities were also sold by way of private placement in certain other jurisdictions outside of Canada and the United States pursuant to and in compliance with applicable securities laws. The securities described herein have not been, and will not be, registered under the U.S. Securities Act, or any U.S. state securities laws, and accordingly, may not be offered or sold to, or for the account or benefit of, persons in the United States or to U.S. Persons (as such terms are defined in Regulation S under the U.S. Securities Act), except in compliance with the registration requirements of the U.S. Securities Act and applicable U.S. state securities requirements or pursuant to exemptions therefrom. This press release does not constitute an offer to sell or a solicitation of an offer to buy any of the Company’s securities. The Agents received a total cash commission of $450,864.11 and 2,254,365 compensation options of the Company (“Compensation Options”). Each Compensation Option entitles the holder to buy one Common Share at a price of $0.20 per Common Share until expiry on August 12, 2028. About Conavi Medical Conavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented hybrid imaging system is the first system to co-register and co-align intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging beams to enable simultaneous hybrid imaging of coronary arteries. The hybrid imaging system has 510(k) clearance from the U.S. Food and Drug Administration. For more information, visit http://www.conavi.com. CONTACT: Chief Financial Officer: Mark Quick, 416-483-0100 Investors: Christina Cameron, 416-483-0100 ext.121, IR@conavi.com Notice on forward-looking statements: This press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding Conavi and its business, which may include, but are not limited to, statements with respect to the anticipated use of proceeds from the Offering. All statements that are, or information which is, not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are “forward-looking information or statements”. Often but not always, forward-looking information or statements can be identified by the use of words such as “shall”, “intends”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate” “anticipate” or any variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “might”, “can”, “could”, “would” or “will” be taken, occur, lead to, result in, or, be achieved. Such statements are based on the current expectations and views of future events of the management of the Company. They are based on assumptions and subject to risks and uncertainties. Although management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including, without limitation, those listed in the “Risk Factors” section of the short form prospectus dated July 29, 2026 (which is available on the Company’s profile at www.sedarplus.ca). Although Conavi has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Conavi does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. No regulatory authority has approved or disapproved the content of this press release. Neither the TSX Venture Exchange nor its Regulatory Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.

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Mineralys Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update

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– PDUFA target date of December 22, 2026 for lorundrostat; commercial preparations on-track for launch upon approval – – Appoints accomplished cardiovascular medicine executive Dr. Terry Ferguson as Chief Medical Officer to lead the Company’s medical and late-stage clinical activities – – Strengthened balance sheet and enhanced the long-term economics of lorundrostat through strategic financing initiatives and the repurchase of the Tanabe royalty obligation – – Conference call today at 4:30 p.m. ET – RADNOR, Pa., Aug. 11, 2026 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and aldosterone-related adverse outcomes in comorbid conditions 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, 2026, and provided a corporate update. “Mineralys is advancing toward an exciting next chapter as we prepare for the commercial launch of lorundrostat, pending FDA approval. The efficacy and safety profile of lorundrostat supports its potential as a compelling treatment option for patients with uncontrolled or resistant hypertension,” said Jon Congleton, Chief Executive Officer of Mineralys. “We are also excited to welcome Terry Ferguson as our new Chief Medical Officer. His extensive experience in cardiovascular medicine strongly positions him to lead our medical organization. David Rodman, who guided the development of lorundrostat from proof of concept through the pivotal program, as well as our recent new drug application filing with the FDA, will continue to contribute to Mineralys in his full-time role as a Strategic Advisor.” “I am very pleased to join the team at Mineralys in advance of the December PDUFA target date,” said Dr. Terry Ferguson, Chief Medical Officer of Mineralys. “Uncontrolled or resistant hypertension is a major driver of cardiovascular morbidity and mortality and a continuing issue for millions of Americans. I look forward to helping bring new treatment options, like lorundrostat, to patients with hypertension and other conditions where modulating dysregulated aldosterone may provide significant benefit.” Recent Highlights and Upcoming Milestones Lorundrostat New Drug Application (NDA) — The U.S. Food and Drug Administration (FDA) continues its review of the NDA for lorundrostat for the treatment of hypertension in combination with other antihypertensive drugs, with a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026.Appointment of New Chief Medical Officer (CMO) — Appointed James J. “Terry” Ferguson III, M.D., as CMO, effective August 10, 2026, succeeding David Rodman, M.D., who will stay on with the Company as a full-time Strategic Advisor. Terry brings more than 35 years of experience in cardiovascular medicine and drug development, including serving as Cardiovascular Therapeutic Area Head at Amgen, nearly a decade in cardiovascular leadership roles at AstraZeneca and The Medicines Company, as well as more than two decades on the faculty of the Texas Heart Institute. Most recently, he served as Chief Medical Officer at Cadrenal Therapeutics. In his new role, Terry will lead Mineralys’ medical and late-stage clinical activities.Transform-HTN Open-Label Extension Trial — The Company’s ongoing Transform-HTN open-label extension trial, which supported the NDA submission, continues to enable participants to receive lorundrostat and generate additional long-term safety and efficacy data.Commercial Launch Readiness — The Company continues to advance commercial launch preparations ahead of lorundrostat’s PDUFA target date of December 22, 2026 and remains on track. An experienced commercial leadership team is now in place, initial sales territories and priority geographies have been identified, and engagement continues with leading hypertension experts and payers covering a substantial majority of U.S. lives. The Company expects to have the sales organization established in advance of the anticipated PDUFA target date.Strengthened Balance Sheet and Lorundrostat Economics — During the second quarter of 2026, Mineralys strengthened its financial position and enhanced the long-term economics of lorundrostat through the following transactions: Completed a follow-on public offering of 5,660,378 shares of common stock, generating gross proceeds of approximately $150.0 million.Entered into a senior secured term loan facility for up to $500.0 million from funds managed by Pharmakon Advisors, LP, including an initial $100.0 million tranche drawn in June 2026.Amended the Tanabe license agreement to eliminate the Company’s royalty obligations, strengthening the Company’s economic rights to lorundrostat. The Company made an upfront cash payment to Tanabe of $200.0 million and agreed to pay additional commercial milestone payments of up to $100.0 million in the aggregate (the New Milestones). As a result, the Company has remaining obligations to pay Tanabe commercial milestone payments, including the New Milestones, of up to $255.0 million in the aggregate upon first commercial sale and upon meeting certain annual sales targets, as well as up to $10.0 million related to commercialization for a potential second indication. Tanabe has also agreed to subsequently assign to Mineralys all of Tanabe’s rights in the licensed intellectual property. Second Quarter 2026 Financial Highlights Cash, cash equivalents and investments were $661.4 million as of June 30, 2026, compared to $656.6 million as of December 31, 2025. The Company believes that its current cash, cash equivalents and investments will be sufficient to fund planned operations, including the commercial launch of lorundrostat, into 2028. Research and development (R&D) expenses for the quarter ended June 30, 2026 were $221.4 million, compared to $38.3 million for the quarter ended June 30, 2025. The increase in R&D expenses was primarily due to the $200.0 million upfront payment to Tanabe in June 2026 in connection with the license agreement amendment. The increase was also due to $0.6 million of increased personnel-related expenses resulting from headcount growth and increased compensation and $0.2 million of increased clinical supply, manufacturing, regulatory and other costs. These increases were partially offset by $17.8 million of lower preclinical and clinical costs, primarily due to the conclusion of the lorundrostat pivotal program in the second quarter of 2025. General and administrative (G&A) expenses were $24.7 million for the quarter ended June 30, 2026, compared to $8.5 million for the quarter ended June 30, 2025. The increase in G&A expenses was primarily due to $8.0 million in higher professional fees, $8.0 million of increased personnel-related expenses resulting from headcount growth and increased compensation and $0.2 million of increased other administrative expenses. Total other income, net was $5.0 million for the quarter ended June 30, 2026, compared to $3.5 million for the quarter ended June 30, 2025. The increase was primarily due to $2.3 million of increased interest earned on investments as a result of higher average cash balances, partially offset by $0.8 million of interest and amortization expense related to the senior secured term loan entered into in June 2026. Net loss was $241.1 million for the quarter ended June 30, 2026, compared to $43.3 million for the quarter ended June 30, 2025. 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 11, 2026. To access the call, please dial 1-877-704-4453 in the United States or 1-201-389-0920 outside the United States, referencing conference ID 13760792. 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 Investors section of the Mineralys website here. About Lorundrostat Lorundrostat is an investigational, proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as related comorbidities, such as CKD, OSA and other diseases driven by dysregulated aldosterone. 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, has an observed half-life of 10-12 hours and demonstrated a 40-70% reduction in plasma aldosterone concentration in participants with hypertension. Mineralys has completed six late-stage clinical trials of lorundrostat supporting its efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN. The clinical program includes two pivotal, registrational trials, the Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, which support the robust, durable and clinically meaningful reductions in systolic blood pressure by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile. About Mineralys Mineralys Therapeutics is a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease, obstructive sleep apnea and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is an investigational, 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, X 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 Mineralys’ current beliefs and expectations and include, but are not limited to, statements regarding: the anticipated timing of the FDA’s review of Mineralys’ accepted NDA and any subsequent regulatory approval of lorundrostat; the potential therapeutic benefits of lorundrostat; Mineralys’ expectations regarding activities to prepare for the commercial launch of lorundrostat; the capital available under Mineralys’ secured debt facility, including the potential to draw down additional tranches thereunder; Mineralys’ expectations with respect to finalizing an agreement with Tanabe to terminate the license agreement and to have Tanabe’s rights in the licensed intellectual property transferred to Mineralys; and the sufficiency of Mineralys’ cash, cash equivalents and investments to fund its operations. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Mineralys’ business, including, without limitation: any delays in the FDA’s review of Mineralys’ accepted NDA, including as a result of a government shutdown or reductions in agency funding or personnel; the results of Mineralys’ clinical trials, including the Launch-HTN and Advance-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for regulatory approval of lorundrostat; later developments with the FDA may be inconsistent with the feedback from prior meetings, including whether the proposed pivotal program will support registration of lorundrostat following the FDA’s review of Mineralys’ NDA submission; the risk that future funding under the secured debt facility may not be available on the timeframe Mineralys expects, or at all, including as a result of its failure to meet the conditions required for such funding or failure to comply with the affirmative and negative covenants under the debt facility; Mineralys may not be able to reach agreement on the proposed termination of its license agreement with Tanabe on its expected timeframe, or at all; Mineralys’ future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; Mineralys’ 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 other trade policies, and the potential for a local and/or global economic recession; Mineralys’ ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; Mineralys’ reliance on its exclusive license with Tanabe to provide Mineralys with intellectual property rights to develop and commercialize lorundrostat; and other risks described in Mineralys’ filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in its 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 Mineralys undertakes 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 Six Months Ended June 30, June 30,  2026   2025   2026   2025 Operating expenses:       Research and development$221,377  $38,278  $245,742  $76,157 General and administrative 24,663   8,468   45,638   15,036 Total operating expenses 246,040   46,746   291,380   91,193 Loss from operations (246,040)  (46,746)  (291,380)  (91,193)Interest income, net 4,956   3,474   10,952   5,713 Other income (expense) 13   (2)  18   (5)Total other income, net 4,969   3,472   10,970   5,708 Net loss$(241,071) $(43,274) $(280,410) $(85,485)Net loss per share attributable to common stockholders, basic and diluted$(2.85) $(0.66) $(3.35) $(1.44)Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 84,727,282   65,451,297   83,786,245   59,341,368                  Mineralys Therapeutics, Inc.Selected Financial InformationCondensed Balance Sheet Data(in thousands)(unaudited)  June 30, December 31,  2026  2025Cash, cash equivalents and investments$661,412 $656,635Total assets$667,853 $661,806Senior secured term loan, net$97,617 $—Total liabilities$116,936 $15,113Total stockholders’ equity$550,917 $646,693

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Microbot Medical® Files 10-Q, Reports Significant Revenue and Customer Growth During the 2026 Second Quarter

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Revenue increased by more than 100% over the prior fiscal quarter, driven by repeat orders, expanded utilization among existing customers, and the acquisition of new customers since the Full Market Release in mid-April The Company added new customers in Q3 while expanding into new states and sites of service HINGHAM, Mass., Aug. 11, 2026 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT), developer and distributor of the innovative LIBERTY® Endovascular Robotic System, announced that it has filed its Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2026 with the Securities and Exchange Commission (SEC). As disclosed in its July 7, 2026 press release, the Company generated greater than 100% revenue and customer growth compared to the first quarter ended March 31, 2026. Second Quarter Highlights Commenced the Full Market Release (FMR) of the LIBERTY System during The Society of Interventional Radiology (SIR) Annual Scientific Meeting in April 2026.New health systems in Massachusetts, North Carolina, Michigan, and Pennsylvania adopted the LIBERTY System, joining Georgia, Florida, and New York, which adopted the LIBERTY System during the Limited Market Release (LMR).Increased the number of hospital sites using the LIBERTY System across existing customer health systems.Procedure volume increased in the second quarter ended June 30, 2026, compared to the first quarter ended March 31, 2026, as customers expanded deployment to additional sites and migrated more users to the LIBERTY System.The LIBERTY System was used across a variety of procedure types, including Prostatic Artery Embolization (PAE), Y-90 Radioembolization, Genicular Artery Embolization (GAE) and Uterine Artery Embolization (UAE), showcasing the versatility of the LIBERTY System.Total revenue was up more than 100% compared to the first quarter of 2026.Having successfully completed the Limited Market Release in April 2026, and with its associated costs partially being accounted for in the second quarter of 2026, coupled with other cost reduction activities which are being implemented, the Company believes it will substantially reduce its cost of revenue which increased in the three-month period ended June 30, 2026 compared to the three-month period ended March 31, 2026.Entered into an agreement with Lovell Government Services Inc. to serve federal healthcare systems, enabling access to more than 2,000 government healthcare facilities.High customer satisfaction is reported and reflected in repeat customer orders for the LIBERTY System as more sites and users are trained on the system.Broadened its sales footprint to eight sales territories compared to four sales territories at the end of March 2026, allowing the Company to be on track to have 12 territories across the U.S. by year-end.Entered into an agreement with Sanmina and is in the process of establishing a second manufacturing site to expand production capacity to support anticipated demand in the U.S. and international markets, as well as future cost reduction initiatives.Achieved a significant regulatory milestone as Israel became the second jurisdiction — and the first outside of the U.S. — to grant marketing clearance for the LIBERTY System.Awarded the 2026 Innovative Start-Up Award from Surgical Robotics Technology (SRT), which recognizes companies with outstanding technological and commercial progress through highly innovative, groundbreaking technologies.1 “We achieved a number of key milestones during the second quarter and first half of 2026, including the successful transition from our Limited Market Release to the Full Market Release earlier in the quarter,” commented Harel Gadot, CEO, President and Chairman. “This resulted in the high growth we saw in both adoption and utilization, leading to a major increase in revenue from the prior period. We are continuing to enhance our commercial team, expand our sales footprint and work closely with existing accounts to expand U.S. sites and increase utilization. At the same time, we continue to implement cost reduction initiatives to lower the cost of revenues. Internationally, we continue to establish a global infrastructure and implement our commercial readiness plans in Europe in anticipation of obtaining a CE Mark.” LIBERTY is the only FDA-cleared, single-use, remotely operated robotic system for peripheral endovascular procedures, and it is designed for precise vascular navigation while aiming to reduce radiation exposure and physical strain. About Microbot MedicalMicrobot Medical Inc. (NASDAQ: MBOT) is a commercial stage medical device company focused on transforming endovascular procedures through advanced robotic technology. Microbot’s LIBERTY® Endovascular Robotic System is the first single-use, remotely operated robotic solution designed for precision, efficiency and safety. Backed by a strong intellectual property portfolio and a commitment to innovation, Microbot is driving the future of endovascular care. Learn more at www.microbotmedical.com and connect on LinkedIn and X. Safe Harbor Statements to future financial and/or operating results, future adoption of products, future growth in research, technology, clinical development, commercialization and potential opportunities for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Any statements that are not historical fact (including, but not limited to statements that contain words such as “contemplates,” “continues,” “could,” “forecasts,” “intends,” “may,” “might,” “possible,” “potential,” “predicts,” “projects,” “should,” “would,” “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates” and similar expressions) should also be considered to be forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements involve risks and uncertainties, including, without limitation, market conditions, risks inherent in the commercialization of the LIBERTY® Endovascular Robotic System, and in the development of future versions of or applications for the system, uncertainty in the results of regulatory pathways and regulatory approvals, uncertainty resulting from political, social and geopolitical conditions, disruptions resulting from new and ongoing hostilities between Israel and the Palestinians, Iran and other neighboring countries, and maintenance of intellectual property rights. Additional information on risks facing Microbot Medical® can be found under the heading “Risk Factors” in Microbot Medical’s periodic reports filed with the Securities and Exchange Commission (SEC), which are available on the SEC’s web site at www.sec.gov. Microbot Medical® disclaims any intent or obligation to update these forward-looking statements, except as required by law. Contacts: IR@microbotmedical.comMedia@microbotmedical.com https://www.surgicalroboticstechnology.com/surgical-robotics-industry-awards/categories/

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Adagio Medical Reports Second Quarter 2026 Results

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LAGUNA HILLS, Calif.–(BUSINESS WIRE)—- $ADGM #ARRHYTHMIA–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 second quarter ended June 30, 2026. Recent Business Highlights: Announced the successful treatment at the Hospital of University of Pennsylvania of the first patient with the Company’s next-generation vCLAS™ Ultra Ultra-Low temperature ablation cat

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CVRx Announces Sales Leadership Transition

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Robert John to Depart as Chief Revenue Officer; Paul Verrastro Named Interim Head of SalesMINNEAPOLIS, Aug. 11, 2026 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced that Robert John, Chief Revenue Officer, will depart the company, and that Paul Verrastro will assume the role of Interim Head of Sales, effective immediately.  In his new role, Mr. Verrastro will lead CVRx’s sales organization while the company conducts a search for a permanent successor. Mr. Verrastro brings more than 30 years of medical device sales and marketing experience to the role. He has been with CVRx for over five years and recently moved into a new senior advisor role focused on commercial execution support.  Prior to assuming this role, he was most recently Chief Marketing and Strategy Officer. Prior to joining CVRx, he held sales and marketing leadership positions at Guidant, Boston Scientific and Medtronic, much of that work focused on bringing novel therapies and technologies to market, including implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT). “Our revised commercial outlook and need to improve commercial execution have led us to make a change in sales leadership,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “I have full confidence in Paul’s ability to lead our sales team while we search for a new leader. He knows our business, our customers and our commercial strategy, and is well respected by the sales force.  This continuity will serve us well as we work through this transition.” About CVRx, Inc. CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.com Media Contact:Emily MeyersCVRx, Inc.763-416-2853emeyers@cvrx.com

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Orchestra BioMed Reports Second Quarter 2026 Financial Results and Highlights Recent Business Updates

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The BACKBEAT global pivotal trial (“BACKBEAT Trial”), conducted in collaboration with Medtronic, is on track to reach its target of 284 evaluable randomized patients by end of Q3 2026, with primary data presentation targeted for Q2 2027, assuming those endpoints are met.Virtue pivotal trial is advancing with further site activations and patient enrollments. $110 million cash balance provides projected runway into Q4 2027 and through key upcoming milestones, following $35 million in strategic capital from Medtronic and Ligand.Company to host R&D Day on November 12, 2026, in New York City, featuring in-depth reviews of both the AVIM Therapy and Virtue SAB programs. NEW HOPE, Pa., Aug. 10, 2026 (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, 2026, and provided a business update on its two pivotal-stage cardiovascular programs: Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) for the treatment of uncontrolled hypertension in pacemaker-indicated patients, being developed in strategic collaboration with Medtronic (NYSE: MDT), and Virtue® Sirolimus AngioInfusion™ Balloon (“Virtue SAB”) for the treatment of coronary in-stent restenosis. David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed, stated, “The second quarter brought clarity on both the timeline and the scope of the AVIM Therapy opportunity that we are pursuing with Medtronic. We remain on track to reach or exceed our target of 284 evaluable randomized patients in the BACKBEAT Trial by the end of the third quarter of 2026 and maintain our objective to present primary endpoint data as a major conference late-breaker in the second quarter of 2027. The second FDA Breakthrough Device Designation for AVIM Therapy earned during the second quarter strengthens potential regulatory and reimbursement upside for this high-impact program.” Hochman continued, “Our conviction that Virtue SAB offers distinctive potential clinical advantages because of its differentiated approach to arterial drug delivery continues to grow as we advance site activations and patient enrollment for the Virtue pivotal trial. With a $110 million cash balance at quarter-end following $35 million received from Medtronic and Ligand during the quarter, both pivotal programs are funded through their next major milestones. We are excited to review each in detail at our R&D Day in November.” Q2 2026 and Recent Business Highlights: BACKBEAT Trial is on track to reach target of 284 evaluable randomized patients by end of Q3 2026. Assuming primary endpoints are met, Orchestra BioMed and Medtronic intend to submit primary endpoint data as a late-breaking clinical trial presentation at a major cardiovascular conference in the second quarter of 2027, followed by marketing application submissions to the FDA and global regulatory agencies.Received $35 million in strategic capital under previously disclosed agreements with Medtronic and Ligand (Nasdaq: LGND). Including this most recent investment, Medtronic’s total capital contribution to Orchestra BioMed is nearly $82 million. Ligand has now provided $40 million in total capital to the Company.FDA granted AVIM Therapy a second FDA Breakthrough Device Designation (“BDD”) specific to patients with uncontrolled hypertension despite anti-hypertensive medication who are indicated for a pacemaker. Together, AVIM Therapy’s two BDDs now cover both the broad group of patients with uncontrolled hypertension and elevated cardiovascular risk and the pacemaker-indicated group studied in the BACKBEAT Trial.Advanced site activation and patient enrollment in the Virtue SAB in the Treatment of Coronary In-Stent Restenosis (“ISR”) Trial (“Virtue Trial”), a multi-center, prospective, randomized head-to-head IDE registrational clinical trial comparing Virtue SAB with the commercially available AGENT™ paclitaxel-coated balloon for the treatment of coronary in-stent restenosis.Added to the Russell 3000® and Russell 2000® Indexes. Effective after the U.S. market close on June 26, 2026, Orchestra BioMed joined the broad-market Russell 3000® Index and the small-cap Russell 2000® Index at the conclusion of the 2026 Russell indexes reconstitution, broadening the Company’s visibility among institutional investors and index funds benchmarked to the Russell indexes. R&D Day: November 12, 2026The Company will host an R&D Day on November 12, 2026 in New York City. The event will feature presentations from management and leading physician investigators covering the AVIM Therapy and Virtue SAB programs, including recent program and pipeline developments. Additional details, including registration and webcast information, will be announced in the future. Financial Results for the Second Quarter Ended June 30, 2026 Cash and cash equivalents and Marketable securities totaled $110.0 million as of June 30, 2026.Net cash used in operating activities and for the purchase of fixed assets was $19.6 million during the second quarter of 2026, compared with $15.6 million for the second quarter in 2025, with the primary drivers being increased research and development costs, including clinical trial activities, as well as personnel and consulting expenditures during the second quarter of 2026.Research and development expenses for the second quarter of 2026 were $16.6 million, compared with $13.9 million for the second quarter in 2025, which represents an increase of 20%. The increase was primarily due to additional costs associated with the ongoing BACKBEAT Trial and to advance the Virtue SAB program, including the Virtue Trial.Selling, general and administrative expenses for the second quarter of 2026 were $5.8 million, compared with $6.3 million for the second quarter of 2025, which represents a decrease of 7%. The decrease was primarily due to a decrease in stock-based compensation expense.Net loss attributable to common stockholders for the second quarter of 2026 was $24.1 million, or ($0.38) per share, compared with a net loss attributable to common stockholders of $19.4 million, or ($0.50) per share, for the second quarter of 2025, which represents an increase of 23%. Net loss attributable to common stockholders for the second quarter of 2026 included $2.7 million in interest expense for the second quarter of 2026 as compared to $0.5 million for the same period in 2025, of which a portion was non-cash in the current period. Non-cash stock-based compensation expense was $2.5 million as compared to $3.2 million for the same period in 2025. 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 by 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 and a global leader in cardiac pacing therapies, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designations 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 non-coated drug delivery angioplasty balloon system designed to deliver a large liquid dose of 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 in-stent restenosis, 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. 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 trial is evaluating 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 two Breakthrough Device Designations by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk. About Virtue SAB Virtue SAB is designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™ through a non-coated microporous AngioInfusion™ Balloon that protects the drug in transit to 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 pilot clinical study of 50 patients 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. 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 enrollment, timing, implementation, results and design of the Company’s ongoing pivotal trials, the timing of the presentation of clinical data, the timing of regulatory submissions, realizing the clinical and commercial value of AVIM Therapy and Virtue SAB, the potential safety and efficacy of the Company’s product candidates, the potential benefits of Breakthrough Device Designation, the ability of the Company’s partnerships to accelerate clinical development and the Company’s projected cash runway. 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, 2025, which was filed with the SEC on March 12, 2026. 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 Contact:Silas NewcombOrchestra BioMedsnewcomb@orchestrabiomed.com  Media Contact:Nina PremuticoOrchestra BioMednpremutico@orchestrabiomed.com  ORCHESTRA BIOMED HOLDINGS, INC.Condensed Consolidated Balance Sheets(in thousands, except share and per share data)(Unaudited)          June 30,    December 31,   2026 2025ASSETS        CURRENT ASSETS:        Cash and cash equivalents $20,472  $34,690 Marketable securities  89,491   71,822 Accounts receivable, net  51   95 Inventory  250   310 Prepaid expenses and other current assets  977   994 Total current assets  111,241   107,911 Property and equipment, net  2,045   1,715 Right-of-use assets  1,171   1,496 Strategic investments                  —     2,495 Deposits and other assets  1,243   1,240 TOTAL ASSETS $115,700  $114,857        LIABILITIES, SERIES A PREFERRED STOCK AND STOCKHOLDERS’ EQUITY      CURRENT LIABILITIES:      Accounts payable $6,132  $6,095 Accrued expenses and other liabilities  6,531   9,890 Operating lease liability, current portion  808   751 Total current liabilities  13,471   16,736 Royalty purchase agreement  34,593   16,482 Note payable  20,442   — Loan payable  14,397   14,268 Derivative liability  2,460   2,749 Operating lease liability, less current portion  520   936 Other long-term liabilities  397   308 TOTAL LIABILITIES  86,280   51,479        Series A Preferred Stock, $0.0001 par value per share; 200,000 issued and outstanding at June 30, 2026 and December 31, 2025; aggregate liquidation preference of $20,000  10,097   9,808        STOCKHOLDERS’ EQUITY        Preferred stock, $0.0001 par value, 10,000,000 shares authorized;  —   — Common stock, $0.0001 par value per share; 340,000,000 shares authorized; 60,105,049 and 57,032,963 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively.  6   6 Additional paid-in capital  426,423   416,083 Accumulated other comprehensive (loss) income  (81)  60 Accumulated deficit  (407,025)  (362,579)TOTAL STOCKHOLDERS’ EQUITY  19,323   53,570 TOTAL LIABILITIES, SERIES A PREFERRED STOCK AND STOCKHOLDERS’ EQUITY $115,700  $114,857           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,   2026 2025Revenue:        Partnership revenue $                  —   667 Product revenue  88   169 Total revenue  88   836 Expenses:        Cost of product revenues  25   46 Research and development  16,590   13,853 Selling, general and administrative  5,829   6,264 Total expenses  22,444   20,163 Loss from operations  (22,356)  (19,327)Other (expense) income:        Interest (expense) income, net  (1,768)  (36)Change in the fair value of derivative liability  324    — Gain on sale of strategic investments  45    — Total other (expense) income  (1,399)  (36)Net loss  (23,755)  (19,363)Adjustment to carrying value of Series A Preferred Stock  (324)  —    Net loss attributable to common stockholders $(24,079)  (19,363)       Net loss attributable to common stockholders per share        Basic and diluted $(0.38)  (0.50)Weighted-average shares used in computing net loss attributable to common stockholders per share, basic and diluted  63,812,098   38,392,716 Comprehensive loss        Net loss $(23,755)  (19,363)Unrealized loss on marketable securities  (41)  (21)Comprehensive loss $(23,796)  (19,384)

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BridgeBio Reports Second Quarter 2026 Financial Results and Corporate Updates

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– $243.7 million in total second quarter revenues, primarily comprised of $222.4 million of U.S. Attruby® net product revenue, with growth led by the treatment-naïve segment as physicians increasingly start and keep patients on Attruby – Attruby is the first ATTR-CM therapy associated with direct kidney protection, with post-hoc analyses published in Circulation: Heart Failure showing a profile consistent with ACE inhibitors, ARBs, and SGLT2s including an early, reversible eGFR dip, an improved chronic eGFR slope relative to placebo, and a 13.7% reduction in urinary albumin-to-creatinine ratio through Month 30; the magnitude of the acute eGFR dip was positively associated with greater early cardiovascular benefit; BridgeBio will explore the potential for Attruby to treat other orphan kidney indications – Real-world evidence continues to differentiate Attruby from tafamidis, with an independent propensity score-matched analysis of 286 patient pairs from the TriNetX network published in JSCAI associating acoramidis with a 37% reduction in composite cardiovascular events (p=0.002) and a 34% reduction in hospitalizations (p=0.002) at six months; further independent RWE using electronic health records are expected, and we are confident Attruby will consistently demonstrate clinical superiority over tafamidis to the benefit of patients and healthcare delivery systems for which heart failure remains a top concern – All three planned NDAs are now submitted to the FDA: BBP-418 for LGMD2I/R9 was accepted with Priority Review (PDUFA November 27, 2026); encaleret for ADH1 was accepted with Priority Review (PDUFA May 8, 2027), with no advisory committee planned for either; oral infigratinib for achondroplasia has been submitted, with U.S. launch expected mid-2027 – Diagnosis and awareness continue to accelerate ahead of the launches: in ADH, more than 2,200 unique patients are now identified under the dedicated ICD-10 code, at approximately 70 new diagnoses per month; in LGMD2I/R9, BridgeBio is investing in awareness and multidisciplinary care at MDA Care Center Network sites, where we expect 85% of target physicians to be familiar with the BBP-418 profile and data by launch – The oral encaleret and oral infigratinib franchises continue to expand beyond their first indications: RECLAIM-HP in chronic hypoparathyroidism has begun screening patients with topline data anticipated in late 2027 or early 2028, CALIBRATE-PEDS in pediatric ADH1 has completed enrollment in its first cohort, and a Phase 2 update in hypochondroplasia is expected in the second half of 2026 – $720.2 million in cash, cash equivalents, and marketable securities as of June 30, 2026, which does not include the $1 billion preferred equity financing that closed on July 1, 2026 – BridgeBio will host a Commercial Day in New York City on October 8, 2026, to discuss commercial readiness and launch strategy across its three upcoming launches PALO ALTO, Calif., Aug. 10, 2026 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, announced today its financial results for the second quarter ended June 30, 2026, and provided an update on Attruby’s commercial progress. Pipeline Overview: ProgramStatusNext expected milestoneAcoramidis for ATTR-CMApproved in U.S., E.U., Japan, Switzerland, Brazil, and U.K.New data to be shared at ESC 2026BBP-418 for LGMD2I/R9PDUFA date set for November 27, 2026 with Priority ReviewLaunch upon FDA approvalEncaleret for ADH1PDUFA date set for May 8, 2027 with Priority Review; MAA submitted to EMALaunch upon FDA approvalOral infigratinib for achondroplasiaNDA submitted to FDAFDA sets PDUFA dateOral Encaleret for chronic hypoparathyroidismFirst investigational sites activated for RECLAIM-HP, Phase 3 studyFirst participant dosed in Q3 2026Oral infigratinib for hypochondroplasiaACCEL 2/3 enrollment ongoingPhase 2 clinical trial update in 2H 2026Depleter for ATTR-CMDevelopment candidate nominationSubmit IND to the FDA in 2027    “I’m excited by the growing body of evidence continuing to demonstrate Attruby is the drug of choice for all ATTR-CM patients, and particularly for those who are treatment-naïve, including the first-ever demonstration of early, sustained kidney-protective effects in ATTR-CM alongside the cardiac benefit we’ve established. Furthermore, this was the quarter all three of our pipeline programs, BBP-418, encaleret, and infigratinib, moved from data into active regulatory review, with our first PDUFA date now set for November 27, 2026, which is a level of strategic execution and discipline I’m proud of. Finally, with the $1 billion preferred equity financing we completed, we have a balance sheet sized to run all three launches at full strength, without diverting resources from the development engine that produced them,” said Neil Kumar, Ph.D., Co-Founder and CEO of BridgeBio. Commercial Updates:The second quarter total revenues, net totaled $243.7 million, comprised of $222.4 million of U.S. Attruby net product revenue, $15.4 million from royalty revenue, and $5.8 million in license and services revenue. “We continue to see strong growth this quarter for Attruby with our first-line share climbing again,” said Matt Outten, Chief Commercial Officer of BridgeBio. “What comes next will continue to shape BridgeBio’s next chapter as we prepare for three potential approvals in three different diseases, all with best-in-class potential, each backed by the same commercial engine that made Attruby a success. We look forward to continuing to deliver for patients and addressing the gaps within the treatment paradigm for rare disease.” Pipeline Updates:Attruby (acoramidis) – First and only near-complete (≥90%) transthyretin (TTR) stabilizer for treatment of transthyretin amyloid cardiomyopathy (ATTR-CM): New post-hoc analyses published in Circulation: Heart Failure showed acoramidis was associated with a rapid, reversible estimated glomerular filtration rate (eGFR) dip alongside a placebo-corrected 15.5% reduction in urinary albumin-to-creatinine ratio (UACR) by Day 28, followed by a sustained improvement in chronic eGFR slope (+2.47 mL/min/1.73m²/year) and a 13.7% UACR reduction through Month 30. This profile resembles that of direct-acting kidney medicines such as ACE inhibitors, ARBs, and SGLT2 inhibitors, and has not previously been observed with any approved ATTR-CM therapy. Participants with larger eGFR dips had a 58% lower risk of death or cardiovascular hospitalization in year one, suggesting the kidney effect may contribute to acoramidis’ early cardiovascular benefit.New data from ATTRibute-CM presented in two late-breaking oral presentations at Heart Failure 2026 further demonstrated acoramidis’ differentiated clinical profile. The first showed a reduction in the risk of outpatient worsening heart failure by 41% versus placebo with separation of curves seen within 30 days and sustained through Month 30. The second showed a significant reduction in serum transthyretin variability, which is associated with lower mortality.Real-world evidence continues to demonstrate that Attruby is differentiated from other therapies in the speed and strength of benefit. An independent propensity score-matched analysis of 286 patient pairs from the TriNetX network, presented at SCAI 2026 Scientific Sessions and published in JSCAI, associated acoramidis with a 37% reduction in composite cardiovascular events (HR 0.63; p=0.002) and a 34% reduction in hospitalizations (HR 0.67; p=0.002) at six months, with effects deepening at nine months and significant reductions across heart failure exacerbation, arrhythmia, and acute kidney injury. A separate propensity score-weighted analysis observed a 43% reduction in outpatient diuretic intensification (HR 0.57; p=0.021) versus tafamidis. A third independent study conducted in EPIC COSMOS and to be published later in 2026 validated the comparative effectiveness of acoramidis over tafamidis. These three real-world datasets converge on consistent, statistically significant benefit in contemporary patients on modern background therapy, reinforcing that Attruby’s stabilization advantage is showing up in outcomes that matter to physicians, patients, and payers.BridgeBio initiated ASCEND-ATTR, a Phase 4 study using cardiac MRI and echocardiography to characterize the long-term effects of acoramidis on disease reversal as measured by cardiac structure, function, and amyloid burden over 36 months. This builds on the evidence of regression observed in ATTRibute-CM and the open-label extension.Additional data will be shared in two oral presentations and six moderated posters at the European Society of Cardiology (ESC) Congress 2026. BBP-418 – Glycosylation substrate for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9): BridgeBio believes BBP-418 is positioned to become the first approved therapy for individuals living with LGMD2I/R9, addressing a significant unmet need in this disease and potentially representing the first approval of a therapy for any form of LGMD.On May 27, 2026, the FDA accepted the Company’s New Drug Application (NDA) for BBP-418 and granted Priority Review, assigning a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026. No advisory committee meeting is currently planned.FORTIFY, the Phase 3 clinical trial of BBP-418, successfully met all pre-specified primary and secondary endpoints of its 12-month interim analysis, supporting its potential as a disease-modifying therapy. The topline results can be found here.Additional positive results demonstrating the rapid and consistent treatment effect and favorable safety profile of BBP-418 were presented in March at the 2026 MDA Clinical and Scientific Conference in a late-breaking oral presentation.1At the 19th International Congress on Neuromuscular Diseases in July 2026, BridgeBio presented interim FORTIFY data showing favorable patient-reported outcomes for BBP-418-treated individuals compared to placebo, demonstrating that the improvements observed on functional outcomes and biomarkers translate to how patients feel and function.BridgeBio invested $100,000 to strengthen multidisciplinary LGMD care through a Muscular Dystrophy Association (MDA) Care Advance Grant supporting initiatives at Stanford Health Care and the University of Minnesota and engaged the LGMD2I/R9 community at the 2026 European LGMD2I/R9 Conference and the 2026 Iowa Wellstone Dystroglycanopathy Patient & Family Conference.BridgeBio’s neuromuscular U.S. field teams are hired, trained, and deployed across medical, commercial, and market access, engaging in scientific exchange, disease state education, and account profiling as appropriate in the pre-approval setting. Promotional activity will commence only upon FDA approval, consistent with regulatory requirements.Based on the FORTIFY interim analysis results, BridgeBio is also engaging regulatory agencies to identify an expedited path to approval for BBP-418 in Europe.The Company intends to initiate clinical studies of BBP-418 in LGMD2I/R9 for individuals less than 12 years of age in the first half of 2027, and in LGMD2M/R13 and LGMD2U/R20 in the near future. Encaleret – Calcium-sensing receptor (CaSR) antagonist for autosomal dominant hypocalcemia type 1 (ADH1) and chronic hypoparathyroidism: BridgeBio believes encaleret is positioned to become the first approved therapy specifically indicated for individuals living with ADH1, in both the U.S. and the EU.The FDA re-considered its review designation of the Company’s NDA filing for encaleret in ADH1 and has granted Priority Review, with a PDUFA target action date of May 8, 2027. No advisory committee meeting is currently planned.BridgeBio submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the use of encaleret in ADH1.Diagnosis of ADH1 in the U.S. continues to accelerate, with more than 2,200 unique patients identified under the dedicated ICD-10 code for ADH (E20.810) from its introduction in October 2023 through June 2026, a rate of approximately 70 new diagnoses per month.CALIBRATE-PEDS, the registrational Phase 2/3 study of encaleret in pediatric ADH1, completed enrollment in the first of four cohorts (adolescents 12 to 17 years of age).RECLAIM-HP, the Phase 3 study of encaleret in chronic hypoparathyroidism, has activated its first investigational sites and screening has initiated. Chronic hypoparathyroidism affects approximately 200,000 patients in the U.S. and EU, and represents a substantial expansion of the encaleret opportunity beyond ADH1. Oral infigratinib – FGFR3 inhibitor for achondroplasia and hypochondroplasia: BridgeBio believes oral infigratinib is positioned to become the first approved oral therapy and a potential best-in-class option for children living with achondroplasia and hypochondroplasia.The Company submitted an NDA to the FDA for oral infigratinib in achondroplasia and is on track to submit an MAA to the EMA in the fourth quarter of 2026. BridgeBio anticipates a U.S. launch in mid-2027 and an EU approval in the second half of 2027.Oral infigratinib has received Breakthrough Therapy, Fast Track, and Rare Pediatric Disease designations from the FDA, and Orphan Drug designation from both the FDA and the EMA.Results from PROPEL 3, the Phase 3 trial of oral infigratinib in achondroplasia, were published in the New England Journal of Medicine2 and simultaneously presented at the International Congress of Children’s Bone Health 2026. Oral infigratinib is the only achondroplasia program with Phase 3 results published in the New England Journal of Medicine. In these results3, oral infigratinib significantly improved arm span Z-score versus placebo (LS mean +0.37 SD; p

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