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

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)

BridgeBio Reports Second Quarter 2026 Financial Results and Corporate Updates

– $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

Feinstein Institutes Finds Mitochondria Transplantation Dramatically Enhances Heart Recovery After Cardiac Arrest

MANHASSET, N.Y.–(BUSINESS WIRE)–With only approximately 10 percent of out-of-hospital cardiac arrest patients surviving, and many facing severe neurological or organ damage, a new study from Northwell Health’s Feinstein Institutes for Medical Research offers hope, revealing that mitochondria transplantation dramatically improves heart recovery and protects organs. Published as a letter to the editor in the American Journal of Respiratory and Critical Care Medicine (AJRCCM), this pivotal large

AQUAPASS Completes Enrollment in REFORM-HF Pivotal Trial, Results to Be Presented at Major Heart Failure Conference This Fall

NEWTON, Mass. and SHEFAYIM, Israel, Aug. 10, 2026 /PRNewswire/ — AQUAPASS, developer of a noninvasive, kidney-independent therapy for fluid overload management in patients experiencing heart failure and chronic or end-stage kidney disease, announced completion of enrollment in its FDA…

Autonomix Medical Congratulates Co-Founder & Chief Medical Officer Dr. Robert Schwartz on Receiving Prestigious 2026 Cardiovascular Tech Forum Lifetime Achievement Award

Recognition honors one of the medical technology industry’s most influential innovators, whose career has helped shape modern cardiovascular care THE WOODLANDS, TX, Aug. 10, 2026 (GLOBE NEWSWIRE) — Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company dedicated to advancing precision nerve-targeted treatments, today congratulated its Chief Medical Officer, Robert Schwartz, M.S., M.D., FACC, on being named the recipient of the 2026 Cardiovascular Tech Forum (CTF) Lifetime Achievement Award, recognizing his extraordinary career and lasting contributions to cardiovascular medicine, innovation and medical technology. Dr. Schwartz will be honored during Octane’s 2026 Cardiovascular Tech Forum on September 18, 2026, in Newport Beach, California. The annual award recognizes individuals whose pioneering work has transformed the cardiovascular technology landscape through scientific achievement, clinical innovation and entrepreneurial leadership. Throughout his distinguished career, Dr. Schwartz has authored more than 500 scientific publications, holds more than 200 patents and has founded multiple medical technology companies whose innovations have changed how the field operates, including the Watchman device, which he co-invented and which was later acquired by Boston Scientific. “Rob’s career has been defined by a relentless pursuit of innovation that has improved the lives of countless patients around the world,” said Brad Hauser, President and Chief Executive Officer of Autonomix. “Few physician innovators have had the breadth of impact that Rob has achieved across cardiovascular medicine and medical technology. From pioneering breakthrough therapies to mentoring entrepreneurs and advancing next-generation medical devices, his vision continues to shape the future of healthcare. We are honored to have him as our Co-Founder and Chief Medical Officer, where his experience and leadership are helping drive Autonomix’s mission to redefine how diseases involving the peripheral nervous system are diagnosed and treated.” Hauser continued, “This well-deserved recognition not only celebrates Rob’s extraordinary legacy but also underscores the caliber of scientific and clinical leadership guiding Autonomix as we continue advancing our first-in-class technology platform.” “I am honored to receive this recognition from the Cardiovascular Tech Forum,” said Dr. Schwartz. “Innovation in medical technology has always been driven by collaboration among physicians, engineers and entrepreneurs committed to improving patient outcomes. I’m grateful to have had the opportunity to contribute to this field throughout my career and look forward to continuing that work through organizations like Autonomix.” The Cardiovascular Tech Forum brings together leading physicians, engineers, entrepreneurs and investors focused on advancing cardiovascular innovation. For more information on CTF 2026, visit their website. About Autonomix Medical, Inc.  Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class platform system technology includes a catheter-based microchip sensing array that may have the ability to detect and differentiate neural signals with greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body.  We are initially developing this technology for the treatment of pain, with initial trials focused on pancreatic cancer, a condition that causes debilitating pain and is without a reliable solution. Our technology constitutes a platform to address dozens of potential indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. Our technology is investigational and has not yet been cleared for marketing in the United States.  For more information, visit autonomix.com and connect with the Company on X, LinkedIn, Instagram and Facebook. Forward Looking Statements  Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Such forward-looking statements can be identified by the use of words such as “should,” “might,” “may,” “intends,” “anticipates,” “believes,” “estimates,” “projects,” “forecasts,” “expects,” “plans,” and “proposes.” Forward-looking statements in this press release include, but are not limited to, expectations regarding the potential effectiveness and clinical benefits of Autonomix’s nerve-targeted treatments for pancreatic cancer pain and other conditions, the versatility and scalability of the Company’s platform technology, the potential for future clinical applications across multiple organ systems, the strength and scope of the Company’s intellectual property portfolio, and the potential for the Company’s patented technologies to support patient selection, procedural guidance and post-treatment monitoring across multiple neuromodulation applications.  Although Autonomix believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on May 27, 2026, and from time to time, our other filings with the SEC. Forward-looking statements speak only as of the date of this press release and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law.  Investor and Media Contact  JTC Team, LLC Jenene Thomas 908.824.0775 autonomix@jtcir.com

Nanox.AI Optimizes Medical Imaging AI Application Framework for Intel Core Ultra Processors with OpenVINO

On-premise medical imaging AI framework uses Intel Core Ultra processors and Intel’s OpenVINO toolkit to accelerate edge inference within healthcare environments PETACH TIKVA, Israel – August 10 – Nanox AI Ltd., a subsidiary of Nano-X Imaging Ltd. (NASDAQ: NNOX), today announced the optimization of its medical imaging AI application framework for Intel CoreUltra processors using Intel’s OpenVINO toolkit. The framework is designed to support AI applications running on an on-premise edge device within healthcare facilities, enabling organizations to evaluate and deploy CT imaging AI applications while keeping imaging data within their own infrastructure. Nanox.AI solutions analyze routine medical CT scans to help identify patients with findings correlated with chronic conditions in areas including cardiac, liver and bone health. By leveraging existing CT imaging workflows, Nanox.AI aims to help healthcare organizations derive additional clinical value from scans that have already been performed and support preventive care management. The optimized AI application framework ran inference successfully and efficiently on Intel Core Ultra-class hardware using OpenVINO, demonstrating its suitability for on-premise AI processing in medical imaging environments. Intel Core Ultra processors provide a heterogeneous AI architecture with CPU, GPU and NPU compute resources, while OpenVINO helps developers optimize and deploy AI workloads across Intel hardware. For healthcare organizations, this combination can support local inference at the edge, help reduce dependence on cloud connectivity, and enable deployment models aligned with hospital infrastructure requirements. “Nanox.AI is focused on helping healthcare organizations deploy advanced medical imaging AI applications efficiently within their existing infrastructure,” said Sharon Saban, General Manager of Nanox.AI. “Our work with Intel demonstrates how optimized edge inference can help bring AI-enabled imaging insights closer to the point of care.” “Healthcare organizations need practical ways to bring AI closer to clinical workflows while supporting performance, responsiveness and local data control,” said Alex Flores, General Manager, Health and Life Science, Edge Computing GroupGoup, Intel. “Nanox.AI’s optimization work with Intel Core Ultra processors and Intel’s OpenVINO toolkit shows how edge AI can help medical imaging applications run efficiently on-premise, giving providers a scalable path to evaluate and deploy AI-enabled insights within their existing infrastructure.” Nanox.AI’s technology has also been featured in Intel’s partner resources as an example of a solution built with Intel technology in Intel’s published partner brief. For more information about Nanox.AI and its suite of solutions, visit www.nanox.vision/ai. ©Intel, the Intel logo and other Intel marks are trademarks of Intel Corporation or its subsidiaries. 1 See intel.com/processor claims: Intel® Core™ Ultra Processors (Series 3). Performance varies by use, configuration, and other factors. Results may vary. Intel does not control or audit third-party data. You should consult other sources to evaluate accuracy. About Nanox Nanox (NASDAQ: NNOX) is focused on driving the world’s transition to preventive health care by delivering an integrated, end-to-end medical imaging and healthcare services platform. Nanox combines affordable imaging hardware, advanced AI-based solutions, cloud-based software, access to remote radiology, health IT solutions, and a marketplace to enable earlier detection, improved clinical efficiency, and broader access to care. Nanox’s vision is to expand the reach of medical imaging both within and beyond traditional hospital settings by providing a seamless solution from scan to interpretation and beyond. By leveraging proprietary digital X-ray technology, AI-driven analytics, and a clinically driven approach, Nanox aims to enhance the efficiency of routine imaging workflows, support early detection of disease, and improve patient outcomes. The Nanox ecosystem includes Nanox.ARC, a cost-effective, 3D multi-source digital tomosynthesis imaging system designed for ease of use and scalability; Nanox.AI, a suite of AI-based algorithms that augment the interpretation of routine CT imaging to identify early signs often associated with chronic disease; Nanox.CLOUD, a cloud-based platform for secure data management, storage, and advanced imaging analytics; Nanox.MARKETPLACE and USARAD Holdings, which provides access to remote radiology and cardiology experts and comprehensive teleradiology services; and Nanox Health IT combines deep healthcare IT expertise with leading technology partners to deliver RIS, PACS, AI, dictation, and secure infrastructure solutions that streamline workflows and support safer, more efficient care delivery. By integrating imaging technology, AI, cloud infrastructure, clinical expertise, a marketplace, and health information technology, Nanox seeks to lower barriers to adoption, improve utilization, and advance preventive care worldwide. For more information, please visit https://www.nanox.vision. About Nanox.AI Nanox.AI is the deep-learning medical imaging analytics subsidiary of Nanox. Nanox.AI solutions are developed to target highly prevalent chronic and acute diseases affecting large populations around the world. Leveraging AI, Nanox.AI helps clinicians extract valuable and actionable clinical insights from medical imaging that otherwise may go unnoticed, potentially initiating further medical assessment to establish individual preventative care pathways for patients. For more information, please visit www.nanox.vision/ai. Forward-Looking Statements This press release may contain forward-looking statements that are subject to risks and uncertainties. All statements that are not historical facts contained in this press release are forward-looking statements. Such statements include, but are not limited to, statements regarding: the Company’s expected commercialization efforts, business strategy and long-term growth opportunities; the expected timing, pace, extent and success of deployments, installations, activations and utilization of Nanox.ARC systems, including under the Nanox Imaging Network; the anticipated benefits, timing and extent of activity under existing commercial, distribution and strategic agreements, including contemplated deployments of hundreds of systems over the coming years; the potential outcome, scope and timing of the evaluation of strategic alternatives relating to the Company’s South Korea operations, including an expanded restructuring, a potential sale, wind-down or closure of all or part of such operations; the initiation, timing, progress and results of the Company’s research and development, manufacturing, and commercialization activities with respect to its X-ray source technology and the Nanox.ARC, the ability to realize the expected benefits of its recent acquisitions and the projected business prospects of the Company and the acquired companies. In some cases, you can identify forward-looking statements by terminology such as “can,” “might,” “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “should,” “could,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information the Company has when those statements are made or management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to (i) Nanox’s ability to complete development of the Nanox System; (ii) Nanox’s ability to successfully demonstrate the feasibility of its technology for commercial applications; (iii) Nanox’s history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of Nanox’s liquidity to pursue its complete business objectives, and substantial doubt regarding its ability to continue as a going concern; (iv) Nanox’s expectations regarding the necessity of, timing of filing for, and receipt and maintenance of, regulatory clearances or approvals regarding its technology, the Nanox.ARC and Nanox.CLOUD from regulatory agencies worldwide and its ongoing compliance with applicable quality standards and regulatory requirements; (v) Nanox’s ability to realize the anticipated benefits of the acquisitions, which may be affected by, among other things, competition, brand recognition, the ability of the acquired companies to grow and manage growth profitably and retain their key employees; (vi) Nanox’s ability to enter into and maintain commercially reasonable arrangements with third-party manufacturers and suppliers to manufacture the Nanox.ARC; (vii) the market acceptance of the Nanox System and the proposed pay-per-scan business model; (viii) Nanox’s expectations regarding collaborations with third-parties and their potential benefits; (ix) Nanox’s ability to conduct business globally; (x) changes in global, political, economic, business, competitive, market and regulatory forces; (xi) risks related to the current war between Israel and Hamas and any worsening of the situation in Israel; and (xii) risks related to litigation which may result in significant liability and damage to the Company’s reputation. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Nanox’s actual results to differ from those contained in the Forward-Looking Statements, see the section titled “Risk Factors” in Nanox’s Annual Report on Form 20-F for the year ended December 31, 2025, and subsequent filings with the U.S. Securities and Exchange Commission. The reader should not place undue reliance on any forward-looking statements included in this press release. Except as required by law, Nanox undertakes no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements to actual results or to changes in the Company’s expectations. Contacts Media Contact:Ben ShannonICR HealthcareNanoxPR@icrinc.com Investor Contact:Mike CavanaughICR Healthcaremike.cavanaugh@icrhealthcare.com

Orion’s license partner Tenax Therapeutics’ Phase 3 LEVEL trial of oral levosimendan in pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) did not reach its primary endpoint

ORION CORPORATION STOCK EXCHANGE RELEASE – INSIDE INFORMATION 10 AUGUST 2026 at 14.05 EEST         Orion’s license partner Tenax Therapeutics’ Phase 3 LEVEL trial of oral levosimendan in pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) did not reach its primary endpoint Orion Corporation’s license partner Tenax Therapeutics, Inc., today announced that the Phase 3 LEVEL clinical trial evaluating oral levosimendan in patients with pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) did not reach its primary endpoint of improvement in the 6-minute walk distance versus placebo, or the key secondary endpoint of improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom score. According to Tenax, prespecified subgroup analyses identified a substantial beneficial treatment effect in patients with greater disease burden, supported by clinically meaningful changes in predefined cardiac biomarker and pulmonary hemodynamic measures across the overall trial population. Oral levosimendan was generally safe and well tolerated, with serious adverse events and adjudicated clinical worsening events balanced across treatment arms. Based on the results of the LEVEL trial, Tenax intends to request a Type C Meeting with the U.S. Food and Drug Administration (FDA) to discuss revisions to the ongoing registrational development of levosimendan for the treatment of PH-HFpEF, and to seek parallel scientific consultation from the European Medicines Agency. Further details on the Phase 3 LEVEL clinical trial topline results can be found on Tenax Therapeutics’ website at https://www.tenaxthera.com. Orion Corporation Liisa HurmePresident and CEO    Mikko KemppainenGeneral Counsel   Contact person:Tuukka Hirvonen, Head of Investor Relations, Orion Corporation tel. +358 10 426 2721                                                   Publisher:Orion CorporationCommunicationsOrionintie 1A, FI-02200 Espoo, Finlandhttp://www.orionpharma.com Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals as well as active pharmaceutical ingredients, combining our trusted expertise with continuous innovation. We have an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by us are used to treat cancer, respiratory diseases and neurological diseases, among others. In 2025 our net sales amounted to EUR 1,890 million, and we employ about 4,000 professionals worldwide, dedicated to building well-being.

ACCESS Announces Multi-Year Strategic Agreement to Bring Advanced Cardiac Electrophysiology Technologies to Ambulatory Surgery Centers

NEW YORK–(BUSINESS WIRE)–ACCESS, through its physician-led group purchasing organization, ACCESS GPO, today announced a multi-year preferred portfolio agreement with Johnson & Johnson to support the adoption of advanced cardiac electrophysiology technologies in ambulatory surgery centers (ASC) across the United States. The agreement encompasses an integrated portfolio of three-dimensional mapping, intracardiac imaging, radiofrequency ablation and pulsed field ablation technologies. The co

Veru Reports Fiscal 2026 Third Quarter Financial Results and Phase 2b PLATEAU Clinical Trial Progress

— Phase 2b PLATEAU clinical trial of enobosarm and semaglutide combination for high quality weight loss is fully enrolled with 239 patients – — Phase 2b PLATEAU clinical trial interim analysis and results on track for calendar Q1 2027– — In June 2026 Company announced a clinical supply agreement with Novo Nordisk for its Phase 2b PLATEAU clinical trial — — In August 2026 Company announced USPTO notice of allowance for key U.S. patent for enobosarm and semaglutide; when issued, U.S. patent protection until at least October 2044 — — Company to host conference call and webcast today at 8:00 a.m. ET – MIAMI, FL, Aug. 10, 2026 (GLOBE NEWSWIRE) — Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced financial results for its fiscal 2026 third quarter ended June 30, 2026, and provided an update on progress of its clinical development programs. “We are extremely pleased with the continued enobosarm progress during this past quarter,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru Inc. “We reached full enrollment of the Phase 2b PLATEAU clinical trial and entered into a clinical supply agreement with Novo Nordisk for the Phase 2b PLATEAU clinical trial.* In addition, we received from the USPTO a notice of allowance for a key U.S. patent for enobosarm with semaglutide for high quality weight loss which when issued, will provide U.S. patent protection until at least October 2044.” Dr. Steiner added: “We believe these accomplishments mark important milestones in advancing enobosarm as a potential important combination therapy with GLP-1 receptor agonists. There is a significant unmet medical need to make weight reduction more tissue selective by maximizing fat loss while preserving lean mass, physical function, and bone mineral density for the highest quality weight reduction especially in older patients who have low muscle reserves and obesity. I want to thank both the patients and the investigators for their enthusiasm to expeditiously reach full enrollment for this very important study. We remain on track to achieve the near-term milestone of reporting the interim analysis results from the Phase 2b PLATEAU clinical trial in the first quarter of calendar year 2027.” Obesity ProgramEvaluating enobosarm in combination with GLP-1 RA for higher quality weight reduction in older patients with obesity Fully Enrolled Phase 2b PLATEAU Clinical StudyThe Phase 2b PLATEAU clinical trial is a double-blind, placebo-controlled study to evaluate the effect of enobosarm 3mg on total body weight, fat mass, lean mass, physical function, bone mineral density and safety in older patients (age ≥ 65 years) who have obesity (BMI ≥ 35) and are initiating semaglutide treatment for weight reduction. During the past quarter, the Company exceeded its Phase 2b PLATEAU clinical trial targeted full enrollment of 200 patients by enrolling 239 patients. The Phase 2b PLATEAU study is designed to assess the ability of enobosarm treatment to break through the weight loss plateau observed in patients with obesity receiving GLP-1 RA treatment by preserving muscle mass and physical function to achieve clinically meaningful incremental weight reduction by 68 weeks. The primary efficacy endpoint of the study is the percent change from baseline in total body weight at 68 weeks. The key secondary endpoints are total fat mass, total lean mass, physical function (stair climb test), mobility disability assessment, bone mineral density, and patient reported outcome questionnaires for physical function, HbA1c, and insulin resistance. Results of an interim analysis assessing lean body mass and fat mass as measured by DXA after patients have completed 32 weeks is expected in the first quarter of calendar year 2027. Final topline clinical data is expected in the fourth quarter of calendar year 2027. The Principal Investigator for the Phase 2b PLATEAU clinical trial is Steven Heymsfield, MD, a Professor and the Director of the Body Composition-Metabolism Laboratory at the Pennington Biomedical Research Center in Baton Rouge, Louisiana. Dr. Heymsfield was also the Principal Investigator of Veru’s Phase 2 QUALITY clinical study. Completed Positive Phase 2b QUALITY Clinical StudyThe Phase 2b QUALITY clinical study was a positive multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial that evaluated the safety and efficacy of enobosarm 3 mg, enobosarm 6 mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in 168 older patients (≥60 years of age) receiving semaglutide (Wegovy®**) for weight reduction. After the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial was completed at 16 weeks, participants continued into a Phase 2b maintenance extension study where all patients discontinued semaglutide treatment, but continued receiving placebo, enobosarm 3 mg, or enobosarm 6 mg as monotherapy in a double-blind fashion for 12 weeks. The Phase 2b QUALITY and Maintenance Extension clinical trial was a positive study that demonstrated that enobosarm plus semaglutide preserved lean mass and physical function and led to greater fat loss during the 16 week active weight loss period and enobosarm monotherapy prevented the regain of weight lost when the GLP-1 RA was discontinued. Recent Developments Regarding Enobosarm Intellectual PropertyRecently the Company received from the United States Patent and Trademark Office (USPTO) a Notice of Allowance for U.S. Patent Application titled “Compositions Comprising Selective Androgen Receptor Modulator Compounds in Combination with Weight Loss Drugs and Uses Thereof for Quality Weight Loss.” The Notice of Allowance indicates that the USPTO has determined that the patent application meets the requirements for patentability and is expected to issue as a U.S. patent. The Notice of Allowance encompasses treatment regimens where: (i) enobosarm is concurrently given with semaglutide; (ii) enobosarm is added to initial semaglutide monotherapy with said co-therapy continuing; and (iii) enobosarm continues or is initiated as monotherapy after semaglutide therapy is discontinued. The allowed claims are directed to the: (i) preservation, restoration, or gaining of lean body mass; (ii) preservation, restoration, or gaining of muscle mass; (iii) enhancement of fat mass loss, including reducing abdominal, subcutaneous, or intramuscular fat accumulation, improving body composition, lowering body fat content, and lowering fat mass; (iv) preservation, restoration, or improvement of physical function and the corresponding prevention or treatment of a number of conditions that can result from decreased physical function such as reducing or treating muscle weakness, poor balance, decreased gait speed, mobility disability, loss of independence, increased risk of falls, loss of physical function, physical disability, poor quality of life, high hospitalization rates, and/or increased mortality; (v) preservation, restoration, or gaining of bone, and the corresponding prevention or treatment of bone fractures; (vi) overcoming or improving of insulin resistance; (vii) improving of HbA1c; (viii) reduction of or treatment to prevent total body weight gain rebound after discontinuing semaglutide; (ix) reduction of or treatment to prevent fat mass gain rebound after discontinuing semaglutide; and (x) treatment to prevent or restore lean mass loss during rebound after discontinuing semaglutide. When issued, this U.S. patent will have a patent expiry of at least October 3, 2044, prior to the potential application of any patent term adjustment or patent term extension. These allowed claims add to the Company’s growing intellectual property portfolio for enobosarm for quality weight loss, including already issued enobosarm specific polymorph composition of matter patents, as well as a number of other pending uses of selective androgen receptor modulator compounds alone or in combination with weight loss drugs for quality weight loss and chronic weight management patent applications.  In addition, the patent portfolio of Veru includes patent applications directed to a novel, oral, modified-release enobosarm formulation, which if such patent were to issue, would provide patent protection until at least May 2046. The Company owns a worldwide portfolio of patent applications directed to the methods of use of enobosarm in combination with weight loss drugs for higher quality weight loss and incremental weight loss. These claims encompass weight loss drugs including incretin containing drugs such as GLP-1 RA drugs. The Company continues to prosecute a number of pending patent applications worldwide covering a number of different weight loss drugs beyond semaglutide. Third Quarter Financial Summary: Fiscal 2026 vs Fiscal 2025 Research and development expenses increased to $4.4 million from $3.0 millionGeneral and administrative expenses decreased to $3.4 million from $5.0 millionOperating loss from continuing operations increased to $7.7 million from $7.5 millionNet loss decreased to $7.0 million, or $0.30 per share, compared to $7.3 million, or $0.50 per share Year-to-Date Financial Summary: Fiscal 2026 vs Fiscal 2025 Research and development expenses decreased to $8.8 million from $12.7 millionGeneral and administrative expenses decreased to $11.5 million from $15.4 millionOperating loss from continuing operations decreased to $20.4 million from $25.9 millionNet loss decreased to $15.1 million, or $0.68 per share, compared to $24.2 million, or $1.65 per share Balance Sheet Information ​​​​​Cash, cash equivalents and restricted cash were $23.9 million as of June 30, 2026 versus $15.8 million as of September 30, 2025 Event DetailsThe audio webcast will be accessible under the Home page and Investors page of the Company’s website at www.verupharma.com. To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call. An archived version of the audio webcast will be available for replay on the Company’s website for approximately three months. A telephonic replay will be available at approximately 12:00 p.m. ET by dialing 1-855-669-9658 (domestic) or 1-412-317-0088 (international), passcode 2565519, for one week. About Veru Inc.Veru is a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin. Enobosarm, an oral selective androgen receptor modulator (SARM), is being developed as a next generation drug that makes weight reduction by GLP-1 RA drugs more tissue selective for loss of fat and preservation of lean mass to improve body composition and physical function which is expected to result in clinically meaningful incremental weight reduction versus GLP-1 RA therapy alone. Sabizabulin, a microtubule disruptor, is being developed for the treatment of chronic inflammation related to atherosclerotic cardiovascular disease. Forward-Looking StatementsThis press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to the planned design, enrollment, timing, commencement, interim, topline and full data readout timing, scope and regulatory pathways for the continued development of enobosarm in patients with obesity, including the PLATEAU Phase 2b study; express or implied statements related to the issuance and scope of coverage, including allowed claims and treatment regimens, of a method of use patent from the Notice of Allowance for US Patent Application titled “Compositions Comprising Selective Androgen Receptor Modulator Compounds in Combination with Weight Loss Drugs and Uses Thereof for Quality Weight Loss”, as well as other pending methods of use and formulation patents; whether the patent application meets requirements of patentability and, if and when the patent is issued, will provide patent protection until at least October 2044; whether new indications will be discovered or granted and whether the allowed claims under said Notice of Allowance, if and when issued, will add additional coverage and protection to new indications and the Company’s growing intellectual property portfolio for enobosarm for quality weight loss, and other pending uses of selective androgen receptor modulator compounds alone or in combination with weight loss drugs; whether the pending patent applications will be approved for claims that encompass a novel, oral, modified-release enobosarm formulation and if issued, will provide patent protection until at least May 2046; the planned design, number of sites, timing, endpoints, patient population and patient size of such trial and whether the PLATEAU trial will successfully meet any of its primary or secondary endpoints; whether the results of the Phase 2b QUALITY study and the extension maintenance study of enobosarm, including weight loss, preservation of lean mass and physical function and loss of fat mass and the prevention of the regain of fat mass and total body weight loss, will be replicated to the same or any degree in the PLATEAU Phase 2b study or in any future Phase 3 studies; whether and when the PLATEAU Phase 2b study of enobosarm will produce an interim analysis and/or topline data; whether enobosarm in combination with a GLP-1 RA drug will provide a higher quality and/or greater quantity weight loss in patients and whether enobosarm will be the next generation combination therapy with GLP-1 receptor agonists for older patients with obesity that makes weight reduction more tissue selective for loss of fat, preservation of lean mass, physical function, improved body composition and maintaining or increasing bone mineral density, and demonstrating favorable HbA1c and insulin resistance results, all while maintaining a favorable safety profile; whether patients treated with enobosarm in the PLATEAU Phase 2B study will break through the weight loss plateau and achieve clinically meaningful incremental weight reduction by preserving muscle mass and physical function whether enobosarm will enhance or achieve a higher quality weight loss or the preservation of muscle in, or meet any unmet need for, obesity patients, including whether it will provide important insights into quality weight loss therapy and the design of a Phase 3 clinical development program; and whether the Company will be successful in its transformation into a late stage biopharmaceutical company focused on obesity and inflammatory disease. The words “anticipate,” “believe,” “could,” “expect,” “intend,” “may,” “opportunity,” “plan,” “predict,” “potential,” “estimate,” “should,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based upon current plans and strategies of the Company and reflect the Company’s current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. The Company assumes no obligation to update any forward-looking statements contained in this press release because of new information or future events, developments, or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to: the development of the Company’s product portfolio and the results of clinical studies, including any interim or topline analysis, possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; although the Company has sought and received feedback from the FDA on the designs of its clinical trials and intends to continue to do so, the FDA may ultimately disagree that the Company’s clinical trials support approval; the Company’s ability to reach agreement with FDA on study design requirements for the Company’s planned clinical studies, including for the Phase 2b program for enobosarm as a weight loss or body composition drug and the number of future Phase 3 studies to be required and the cost thereof; potential delays in the timing of and results from clinical trials and studies, including as a result of an inability to enroll sufficient numbers of patients in clinical studies or an inability to enroll patients in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; the Company plans to prioritize the use of its current internal cash to the development of enobosarm, with a primary near-term focus on funding its PLATEAU Phase 2b clinical trial, and as a result advancement of sabizabulin as a treatment for slowing progression of or promoting regression of atherosclerosis disease will depend upon the Company securing additional funding; whether the Company will be able to partner with another company in the development of enobosarm or sabizabulin; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the potential for disruptions at the FDA or other government agencies to negatively affect our business, including as a result of a future shutdown of the U.S. government; any products of the Company, if approved, possibly not being commercially successful; the risk that the Supply Agreement with Novo Nordisk could be terminated prior to the completion of the Company’s PLATEAU Phase 2b clinical trial, including pursuant to a provision that permits Novo Nordisk to terminate for convenience upon 60 days’ prior notice; the ability of the Company to obtain sufficient financing, including any partnership or collaboration agreements, on acceptable terms when needed to fund development and operations and to enable us to continue as a going concern; the effect of the SEC’s “baby shelf” rules on the Company’s ability to raise sufficient capital when needed; demand for, market acceptance of, and competition against any of the Company’s products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; the Company’s ability to obtain, protect and enforce its data, intellectual property and other proprietary rights; costs and other effects of litigation, including regulatory challenges, product liability claims, intellectual property claims and challenges, securities litigation and litigation with the purchaser of the Company’s FC2 business; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company’s Form 10-K for the year ended September 30, 2025, and subsequent quarterly reports on Form 10-Q. These documents are available on the “SEC Filings” section of our website at www.verupharma.com/investors. *During the past quarter the Company announced a clinical supply agreement with Novo Nordisk for its Phase 2b PLATEAU clinical study. Please see the Company’s SEC Form 8-K dated June 2, 2026 for further details. **Wegovy® is a registered trademark of Novo Nordisk A/S. FINANCIAL SCHEDULES FOLLOW Veru Inc.Condensed Consolidated Balance Sheets(unaudited)       June 30,  September 30,  2026  2025         Cash, cash equivalents, and restricted cash$23,880,142  $15,794,562 Investments in equity securities 1,911,386   2,525,305 Prepaid expenses and other current assets 1,436,799   595,251 Total current assets 27,228,327   18,915,118         Property and equipment, net 280,227   364,808 Operating lease right-of-use assets 2,342,186   2,746,014 Goodwill 6,878,932   6,878,932 Other assets 297,998   930,847 Total assets$37,027,670  $29,835,719         Accounts payable$1,709,689  $3,121,448 Accrued compensation 2,721,934   3,510,237 Accrued expenses and other current liabilities 949,092   394,529 Operating lease liability, short-term portion 775,157   758,946 Total current liabilities 6,155,872   7,785,160         Operating lease liability, long-term portion 1,907,735   2,358,018 Other liabilities 587,823   1,359,871 Total liabilities 8,651,430   11,503,049         Total stockholders’ equity 28,376,240   18,332,670 Total liabilities and stockholders’ equity$37,027,670  $29,835,719  Veru Inc.Condensed Consolidated Statements of Operations(unaudited)        Three Months Ended  Nine Months Ended  June 30,  June 30,  2026  2025  2026  2025                 Operating expenses:               Research and development$4,352,668  $3,020,563  $8,842,633  $12,669,495 General and administrative 3,361,013   5,010,528   11,514,031   15,402,074 Total operating expenses 7,713,681   8,031,091   20,356,664   28,071,569                 Gain on sale of ENTADFI® assets —   484,615   —   2,154,134                 Operating loss (7,713,681)  (7,546,476)  (20,356,664)  (25,917,435)                Non-operating income:               Gain on extinguishment of debt —   —   —   8,624,778 Other non-operating income, net 725,331   223,375   4,943,185   307,260 Total non-operating income 725,331   223,375   4,943,185   8,932,038                 Net loss from continuing operations (6,988,350)  (7,323,101)  (15,413,479)  (16,985,397)Net (loss) income from discontinued operations, net of taxes —   (9,719)  351,418   (7,194,389)Net loss$(6,988,350) $(7,332,820) $(15,062,061) $(24,179,786)                Net loss from continuing operations per basic and diluted common shares and pre-funded warrants outstanding$(0.30) $(0.50) $(0.70) $(1.16)Net income (loss) from discontinued operations per basic and diluted common shares and pre-funded warrants outstanding$0.00  $(0.00) $0.02  $(0.49)Net loss per basic and diluted common shares and pre-funded warrants outstanding$(0.30) $(0.50) $(0.68) $(1.65)                Basic and diluted weighted average common shares outstanding 23,050,320   14,657,777   22,127,243   14,644,927  Veru Inc.Condensed Consolidated Statements of Cash Flows(unaudited)     Nine Months Ended  June 30,  2026  2025         Net loss$(15,062,061) $(24,179,786)        Adjustments to reconcile net loss to net cash used in operating activities (2,482,190)  3,920,100         Changes in operating assets and liabilities (3,007,404)  (4,292,066)        Net cash used in operating activities (20,551,655)  (24,551,752)        Net cash provided by investing activities 5,322,804   18,867,232         Net cash provided by (used in) financing activities 23,314,431   (4,221,611)        Net increase (decrease) in cash, cash equivalents, and restricted cash 8,085,580   (9,906,131)        Cash, cash equivalents and restricted cash at beginning of period 15,794,562   24,916,285         Cash, cash equivalents and restricted cash at end of period$23,880,142  $15,010,154  Investor and Media Contact: Samuel FischExecutive Director, Investor Relations and Corporate CommunicationsEmail: veruinvestor@verupharma.com