$15 million payment fulfills previously scheduled tranche under royalty-based financing agreement, bringing total capital received from Ligand to $40 million to date in exchange for tiered royalty interest in Orchestra BioMed’s future revenue as well as equityFunding supports continued execution of Orchestra BioMed’s pivotal trials for Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) and Virtue Sirolimus AngioInfusion Balloon (“Virtue SAB”) This payment, together with a $20 million investment from Medtronic (NYSE: MDT) announced separately, represents a total of $35 million in fresh strategic capital received on May 1, 2026 under previously disclosed agreements NEW HOPE, Pa., May 06, 2026 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, today announced the receipt of a $15 million payment from Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) pursuant to the previously disclosed Revenue Participation Right Purchase and Sale Agreement (the “Royalty Purchase Agreement”). The payment completes a scheduled tranche under the agreement and reflects Ligand’s continued strategic capital support of Orchestra BioMed’s late-stage cardiovascular programs, AVIM Therapy and Virtue SAB, which are both being evaluated in ongoing randomized, controlled pivotal trials. Todd Davis, Chief Executive Officer of Ligand, commented: “We are pleased to complete this second tranche investment to Orchestra BioMed as the Company continues to advance pivotal trials for its two compelling, proprietary cardiovascular therapies, AVIM Therapy and Virtue SAB. Both device-based therapies have the potential to meaningfully improve outcomes for patients with significant unmet medical needs. Since our initial tranche investment, Orchestra has made strong progress, including continued acceleration of the BACKBEAT Trial enrollment, partnership realignment with Terumo, and the initiation of patient enrollment in the Virtue Trial. This progress reinforces our confidence in Orchestra BioMed’s ability to execute across both programs, and we look forward to key upcoming clinical and corporate milestones.” “We and Ligand designed our strategic capital partnership to align funding with execution, and the receipt of this additional tranche from Ligand reflects continued and timely progress against that plan,” said David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed. “We congratulate Ligand on an outstanding run of recent successes in its portfolio and its continued strategic growth. We believe Orchestra BioMed’s programs can contribute meaningfully to Ligand’s continued royalty growth in the next few years. As we advance both of our pivotal-stage programs, this type of partnership-driven capital enables us to remain focused on delivering results that enhance the long-term value potential of both AVIM Therapy and the Virtue platform.” The $15 million investment follows an initial $20 million investment received at closing of the initial tranche under the Royalty Purchase Agreement on August 4, 2025 and completes Ligand’s $35 million royalty financing commitment under the Royalty Purchase Agreement. As previously announced, Ligand also purchased an additional $5 million of Orchestra BioMed common stock in an equity private placement in August 2025. This payment, together with a $20 million investment from Medtronic announced separately, represents a total of $35 million in fresh strategic capital received by Orchestra BioMed on May 1, 2026 under previously disclosed agreements. 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, one of the largest medical device companies in the world and the 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 LigandLigand is a leading royalty aggregator, partnering with biopharmaceutical companies to finance and advance late-stage clinical development programs. Ligand owns and manages one of the largest and most diversified portfolios of biopharmaceutical royalties in the industry, with economic interests in more than 100 development and commercial-stage assets. Ligand funds high-value programs in exchange for long-term economic interests, aligning capital with clinical and commercial success. Ligand’s royalty portfolio is designed to deliver consistent and predictable revenue streams across a broad range of therapeutic assets. Ligand also licenses its proprietary technologies, Captisol® and NITRICIL™, to support drug development and formulation across its global partner network. For more information, visit www.ligand.com or follow Ligand on X and LinkedIn. References to information included on, or accessible through, Ligand’s websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release. About AVIM TherapyAVIM Therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM Therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM Therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study 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 SABVirtue 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 initiation, enrollment, timing, implementation and design of the Company’s ongoing pivotal trials, 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, and the ability of the Company’s partnerships to accelerate clinical development. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 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:Kelsey KirkOrchestra BioMedkkirkellis@orchestrabiomed.com
Tag: Orchestra BioMed
FDA Grants Orchestra BioMed Additional Breakthrough Device Designation for AVIM Therapy
Atrioventricular Interval Modulation (“AVIM”) Therapy Food and Drug Administration (“FDA”) Breakthrough Device Designations span the broader population of patients with uncontrolled hypertension despite medication at increased cardiovascular risk and the specific pacemaker-indicated population being evaluated in the BACKBEAT TrialThe addressable U.S. patient population for AVIM Therapy, based on the indications for use specified in its Breakthrough Device Designations, comprises over 7.7 million adults with hypertension despite medicationBreakthrough Device Designation supports favorable reimbursement pathways, including potential eligibility for New Technology Add-on Payment (“NTAP”) and Transitional Pass-Through (“TPT”) payment, which can facilitate broader, more timely patient access and provider adoption NEW HOPE, Pa., April 30, 2026 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, today announced that the FDA has granted a second Breakthrough Device Designation (“BDD”) for AVIM Therapy specific to patients with uncontrolled hypertension despite the use of anti-hypertensive medications, and an indication for a pacemaker. Together, the two BDDs for AVIM Therapy cover indications that encompass both the broader population of patients with uncontrolled hypertension despite medication and increased cardiovascular risk as well as the specific pacemaker-indicated population with uncontrolled hypertension being evaluated in the BACKBEAT Global Pivotal Trial (“BACKBEAT Trial”), which Orchestra BioMed is conducting in collaboration with Medtronic (NYSE: MDT). This additional BDD supports strategic optionality for the clinical, regulatory and commercial reimbursement strategies for AVIM Therapy for both the pacemaker population and potential future expansion populations with uncontrolled hypertension and increased cardiovascular risk. “We are pleased to receive this additional Breakthrough Device Designation from the FDA. We believe it is directly aligned with the patient population being studied in our ongoing BACKBEAT Trial which we are executing in collaboration with Medtronic,” said David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed. “Continued alignment from the FDA, alongside our strategic relationship with Medtronic and accelerated enrollment in the BACKBEAT Trial, puts us in a strong position to advance AVIM Therapy to pivotal trial results.” Orchestra BioMed has a strategic collaboration with Medtronic, the global market leader in cardiac pacing therapies, for development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. Under the terms of the existing collaboration agreement, Medtronic holds the right of first negotiation to expand its licensing agreement with Orchestra BioMed to obtain global rights to commercialize AVIM Therapy for the treatment of uncontrolled hypertension in patients that do not have an indication for a pacemaker. The FDA Breakthrough Devices Program, which reflects the FDA’s commitment to device innovation and protecting public health, is designed to expedite the development of and provide priority review for innovative medical technologies that have the potential to significantly improve outcomes for patients with serious or life-threatening conditions. To be eligible for this designation, a device must demonstrate the potential to provide more effective treatment or diagnosis of a life-threatening or irreversibly debilitating condition. In addition, the device must meet at least one of the following criteria: it must represent breakthrough technology, have no approved or cleared alternatives, offer significant advantages over existing options, or be determined by the FDA to be in the best interest of patients. Beyond regulatory acceleration, the BDD may also support favorable reimbursement pathways, including eligibility for incremental inpatient reimbursement through the New Technology Add-on Payment and outpatient Transitional Pass-Through payments under the Centers for Medicare & Medicaid Services programs. These mechanisms may help facilitate more timely access to breakthrough technologies while supporting provider adoption and patient access. 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, one of the largest medical device companies in the world and the 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 TherapyAVIM Therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM Therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM Therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will evaluate the safety and efficacy of AVIM Therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM Therapy has been granted two Breakthrough Device Designations by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the initiation, enrollment, timing, implementation and design of the Company’s ongoing pivotal trials, 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 BDD, including its ability to expedite FDA reviews and support favorable reimbursement pathways, and the ability of the Company’s partnerships to accelerate clinical development. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 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:Kelsey KirkOrchestra BioMedkkirkellis@orchestrabiomed.com
Orchestra BioMed Reports Full Year 2025 Financial Results and Provides Fourth Quarter Business Update
$106.5 million cash position as of December 31, 2025 to be further enhanced by $35 million expected from Medtronic and Ligand in Q2 2026 from previously announced transactions, as well as Haemonetics’ Vivasure acquisition proceeds$33.5 million in 2025 non-recurring revenue primarily driven by impact of new Virtue SAB agreement with Terumo that was announced in October 2025Strong balance sheet supports focused execution of pivotal trials for both AVIM Therapy and Virtue SAB programs NEW HOPE, Pa., March 12, 2026 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, today reported its full year 2025 financial results and provided a fourth quarter business update. David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed stated, “We are very proud of our significant clinical, strategic and financing accomplishments in 2025. We are now in an excellent financial and operational position to achieve upcoming value-driving milestones for both of our pivotal stage programs. In the second half of 2025, we leveraged our partnership-driven business model to substantially strengthen our financial position with nearly $150 million in new capital and capital commitments, including strategic transactions with Medtronic, Ligand and Terumo. With a strong balance sheet in place, we are fully focused on driving pivotal trial execution for both AVIM Therapy and Virtue SAB, high impact therapies designed to address major unmet needs in large, established global procedure markets.” Hochman continued, “As we enter 2026 with two pivotal trials underway, we remain focused on disciplined execution and long-term value creation for patients, clinicians and shareholders. We are encouraged by the accelerated pace of enrollment in the BACKBEAT global pivotal study following protocol amendments implemented in the fourth quarter and we plan to provide a substantive update in our next quarterly report. We are also pleased with the early progress of the Virtue Trial, which we initiated during the fourth quarter of 2025. We expect to provide additional updates on this trial, which is randomizing coronary in-stent restenosis patients to treatment with Virtue SAB versus the AGENT™ paclitaxel-coated balloon, as we gain further visibility into enrollment trends over the course of the year.” Q4 2025 and Recent Business Highlights: Accelerated patient enrollment of the BACKBEAT global pivotal study, in collaboration with Medtronic (NYSE: MDT), evaluating the efficacy and safety of Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) for the treatment of uncontrolled hypertension in patients indicated for a pacemaker.Initiated patient enrollments in the Virtue SAB U.S. pivotal trial, a randomized head-to-head IDE registrational clinical trial comparing Virtue SAB with the commercially available AGENT paclitaxel-coated balloon for the treatment of coronary in-stent restenosis (the “Virtue Trial”).Entered into an agreement with Terumo (“ROFR Agreement”) pursuant to which we and Terumo terminated our distribution agreement, and Orchestra BioMed granted Terumo a right of first refusal (the “ROFR”) with respect to certain strategic transactions relating to Virtue® Sirolimus AngioInfusionTM Balloon (“Virtue SAB”) for the treatment of coronary artery disease globally in exchange for a fee of $10.0 million. In connection with the ROFR Agreement, Terumo invested an additional $20.0 million in Orchestra BioMed through a new series of non-voting convertible preferred stock (the “Series A Preferred Stock”), which is convertible into common stock in the future, subject to certain conditions, at a minimum of $12 per share.Up to $21 million in total proceeds expected in connection with the acquisition of Vivasure Medical, previously a strategic holding of Orchestra BioMed, by Haemonetics. Orchestra BioMed expects to receive up to $10.7 million of these proceeds in 2026, including an initial upfront payment of $4.7 million received in January 2026 and the remainder expected later in the year as a first-milestone payment. The Company may receive additional proceeds in the future associated with potential revenue earnouts. Financial Results for the Year Ended December 31, 2025 Revenue for 2025 was $33.5 million, compared with $2.6 million for 2024, which represents an increase of 1,539%. The increase is primarily due to recognizing the remainder of the deferred revenue from our prior distribution agreement with Terumo of $15.4 million as a result of the termination of that agreement, $10.0 million in consideration for the ROFR, and $7.4 million associated with the premium paid above the fair market value of the Series A Preferred Stock.Research and development expenses for 2025 were $58.2 million, compared with $42.8 million for 2024, which represents an increase of 36%. The increase was primarily due to additional costs associated with the ongoing BACKBEAT global pivotal study and to advance the Virtue SAB program, including the Virtue Trial.Selling, general and administrative expenses for 2025 were $26.9 million, compared with $23.9 million for 2024, which represents an increase of 12%. The increase was primarily due to an increase in professional fees.Net loss attributable to common stockholders for 2025 was $52.7 million, or ($1.11) per share, compared with a net loss attributable to common stockholders of $61.0 million, or ($1.66) per share, for 2024 which represents a decrease of 14%. Net loss attributable to common stockholders for the year-ended 2025 included non-cash stock-based compensation expense of $12.0 million, compared with $10.6 million for the same period in 2024, representing an increase of 13%.Net cash used in operating activities and for the purchase of fixed assets excluding the payment for the ROFR and the Series A Preferred Stock premium, which was recognized as revenue, was $66.9 million during 2025, compared with $50.8 million for 2024, with the primary driver of this increase being increased cash outflows for research and development, including clinical trial activities, during 2025.Cash and cash equivalents and Marketable securities totaled $106.5 million as of December 31, 2025. The Company has commitments from Ligand and Medtronic to receive a combined $35.0 million in additional proceeds on or before May 1, 2026, based on the terms of agreements with those parties and subject to the conditions therein. Additionally, in January 2026, Haemonetics closed on the acquisition of Vivasure in which we expect to receive up to $10.7 million of proceeds in 2026, consisting of an upfront payment of approximately $4.7 million, which has already been received, and approximately $6.0 million expected to be received in a first milestone payment. About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates – Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) – are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designation for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind 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 ISR, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. 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 proceeds expected to be received by the Company pursuant to the achievement of certain milestones in connection with the acquisition of Vivasure by Haemonetics; and the timing of any update on anticipated enrollment completion and potential primary endpoint results with respect to the BACKBEAT global pivotal study as well as the provision of any update on the Virtue Trial. 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:Kelsey Kirk-EllisOrchestra BioMedkkirkellis@orchestrabiomed.com ORCHESTRA BIOMED HOLDINGS, INC.Consolidated Balance Sheets(in thousands, except share and per share data)(unaudited) December 31, December 31, 2025 2024 ASSETS CURRENT ASSETS: Cash and cash equivalents $34,690 $22,261 Marketable securities 71,822 44,551 Accounts receivable, net 95 92 Inventory 310 173 Prepaid expenses and other current assets 994 2,094 Total current assets 107,911 69,171 Property and equipment, net 1,715 1,384 Right-of-use assets 1,496 2,103 Strategic investments 2,495 2,495 Deposits and other assets 1,240 1,020 TOTAL ASSETS $114,857 $76,173 LIABILITIES, SERIES A PREFERRED STOCK AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Accounts payable $6,095 $5,134 Accrued expenses and other liabilities 9,890 6,084 Operating lease liability, current portion 751 550 Deferred revenue, current portion — 4,439 Total current liabilities 16,736 16,207 Deferred revenue, less current portion — 10,989 Royalty purchase agreement 16,482 — Loan payable 14,268 14,292 Derivative liability 2,749 — Operating lease liability, less current portion 936 1,687 Other long-term liabilities 308 40 TOTAL LIABILITIES 51,479 43,215 Series A Preferred Stock, $0.0001 par value per share; 200,000 issued and outstanding at December 31, 2025 and 0 issued and outstanding at December 31, 2024; aggregate liquidation preference of $20,000 at December 31, 2025 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; 57,032,963 and 38,194,442 shares issued and outstanding as of December 31, 2025 and December 31, 2024, respectively. 6 4 Additional paid-in capital 416,083 342,780 Accumulated other comprehensive income 60 52 Accumulated deficit (362,579) (309,878)TOTAL STOCKHOLDERS’ EQUITY 53,570 32,958 TOTAL LIABILITIES, SERIES A PREFERRED STOCK AND STOCKHOLDERS’ EQUITY $114,857 $76,173 ORCHESTRA BIOMED HOLDINGS, INC.Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share data)(unaudited) Year Ended December 31, 2025 2024 Revenue: Partnership revenue $32,871 $2,005 Product revenue 611 633 Total revenue 33,482 2,638 Expenses: Cost of product revenues 190 204 Research and development 58,185 42,804 Selling, general and administrative 26,914 23,931 Total expenses 85,289 66,939 Loss from operations (51,807) (64,301)Other (expense) income: Interest (expense) income, net (1,148) 3,356 Change in the fair value of derivative liability 254 — Loss on fair value of strategic investments — (68)Other expense — (11)Total other (expense) income (894) 3,277 Net loss (52,701) (61,024)Adjustment to carrying value of Series A Preferred Stock (254) — Net loss attributable to common stockholders $(52,955) $(61,024) Net loss attributable to common stockholders per share Basic and diluted $(1.11) $(1.66)Weighted-average shares used in computing net loss attributable to common stockholders per share, basic and diluted 47,747,078 36,821,042 Comprehensive loss Net loss $(52,701) $(61,024)Unrealized gain on marketable securities 8 62 Comprehensive loss $(52,693) $(60,962)
Orchestra BioMed Announces Presentations Highlighting AVIM Therapy Potential Impact on Hypertensive Heart Disease and Heart Failure at THT and CRT
NEW HOPE, Pa., March 03, 2026 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, today announced two presentations that will be given at the Technology Heart Failure and Therapeutics (“THT”) and Cardiovascular Research Technologies (“CRT”) 2026 Meetings highlighting the potential for the Company’s Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) program in hypertensive heart disease and heart failure patients. Presentation at THT 2026Atrioventricular Interval Modulation Therapy: A Device-Based Therapy for Hypertension and Diastolic Heart Failure (Tuesday, March 3, 2026, at 10:20am ET) Presenter: David E. Kandzari, MD, FACC, MSCAI, Chief, Piedmont Heart Institute and Cardiovascular Services, Co-Principal Investigator for the BACKBEAT global pivotal study (“BACKBEAT Study”)Dr. Kandzari will present mechanistic and clinical data highlighting the potential application of AVIM Therapy to treat diastolic dysfunction, a precursor of heart failure with preserved ejection fraction (“HFpEF”). The presentation will highlight pilot study data demonstrating sustained systolic blood pressure reductions associated with delivery of AVIM Therapy alongside improvements in cardiac hemodynamics, ventricular remodeling, and echocardiographic measures of diastolic function. Dr. Kandzari commented, “AVIM Therapy has the potential to offer a new treatment paradigm that leverages active implantable devices with a long, established clinical history. The BACKBEAT Study, which continues to accelerate and build momentum, is focused on evaluating the potentially compelling benefit of this novel, always-on therapy for hypertension in pacemaker-indicated patients. In parallel, pilot study clinical and mechanistic results demonstrate that modulation of the atrioventricular interval drives hemodynamic and autonomic nervous system function impact that could help patients with HFpEF, a population with limited therapeutic options. Together, the presentations at the THT and CRT meetings underscore that AVIM Therapy has the future potential to benefit both hypertensive heart disease and heart failure patients.” Presentation at CRT 2026Update on AVIM Therapy: A Pacemaker-Based Treatment for Hypertension (Sunday, March 8, 2026, at 9:18am ET) Presenter: Dan Burkhoff, MD, PhD, Director, Heart Failure, Hemodynamics and MCS Research, Cardiovascular Research FoundationDr. Burkhoff will summarize the robust body of pilot study clinical evidence demonstrating sustained and reproducible systolic blood pressure reductions associated with delivery of AVIM Therapy, along with improvements in hemodynamics, ventricular remodeling, and stable long-term outcomes in pacemaker-indicated patients with hypertension. Dr. Burkhoff added, “In pilot studies, AVIM Therapy demonstrated an immediate reduction in systolic blood pressure that starts upon treatment activation and persists through nearly four years of follow-up. Long-term washout pilot study data demonstrating reproducible blood pressure reduction without evidence of disease progression further highlight the unique potential clinical utility of this therapy. Sustained blood pressure control in higher risk, older, comorbid patients that does not require additional patient adherence to daily medications can have important clinical impact in a population where blood pressure management is essential to reducing the risk of stroke, myocardial infarction, and heart failure.” About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates – Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) – are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designation for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind 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 study will evaluate the safety and efficacy of AVIM Therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM Therapy has been granted Breakthrough Device Designation by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the initiation, enrollment, timing, implementation and design of the Company’s ongoing pivotal trials, realizing the clinical and commercial value of AVIM Therapy and Virtue SAB, the potential safety and efficacy of the Company’s product candidates, and the ability of the Company’s partnerships to accelerate clinical development. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 31, 2025 and the risk factor discussed under the heading “Item 1A. Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, which was filed with the SEC on May 12, 2025. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor Contact:Silas NewcombOrchestra BioMedSnewcomb@orchestrabiomed.com Media Contact:Kelsey Kirk-EllisOrchestra BioMedkkirkellis@orchestrabiomed.com
Orchestra BioMed to Participate in Upcoming Institutional Investor Conferences
NEW HOPE, Pa., Feb. 19, 2026 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, today announced that company management will participate in multiple upcoming institutional investor conferences. Details on the Company’s participation appear below: TD Cowen 46th Annual Health Care Conference – March 2-4, 2026 (Boston, MA) Management will participate in a live fireside chat at 9:50am ET on Tuesday, March 3rd and will also host one-on-one meetings with investors. The event will be accessible to investors and interested parties via a live webcast, which will be available live via this link, as well as after the event on Orchestra BioMed’s Investor Relations website. Barclays 28th Annual Global Healthcare Conference – March 10-12, 2026 (Miami, FL) Management will participate in a live fireside chat at 8:00am ET on Wednesday, March 11th and will also host one-on-one meetings with investors. The event will be accessible to investors and interested parties via a live webcast, which will be available live via this link, as well as after the event on Orchestra BioMed’s Investor Relations website. About Orchestra BioMedOrchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates – Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) – are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designation for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind 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 ISR, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. Investor Contact:Silas NewcombOrchestra BioMedSnewcomb@orchestrabiomed.com Media Contact:Kelsey Kirk-EllisOrchestra BioMedkkirkellis@orchestrabiomed.com
Orchestra BioMed to Receive Up to $21 Million in Proceeds from Acquisition of Vivasure by Haemonetics
$11 million in proceeds expected to be received during 2026, with remainder of expected proceeds to be received in future revenue earnoutsVivasure Medical Limited (“Vivasure”) has been a strategic holding of Orchestra BioMed since the Company’s formation NEW HOPE, Pa., Jan. 12, 2026 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced that it expects to receive up to $21 million in cash proceeds in connection with the acquisition of Vivasure, an Ireland-based company pioneering next-generation technology for percutaneous vessel closure, by Haemonetics Corporation (NYSE: HAE, “Haemonetics”), which closed on January 9, 2026. Vivasure was a strategic holding of Orchestra BioMed prior to the transaction. In connection with the closing of the transaction, Orchestra BioMed expects to receive $11 million of proceeds in 2026 made up of approximately $5 million upfront and approximately $6 million in a first milestone payment. The remainder of the proceeds are expected to be received in future revenue earnouts based on the achievement of certain milestones. Vivasure’s PerQseal® Elite system uses a proprietary bioabsorbable patch to seal large-bore (up to 26 F) arteriotomies and venotomies from inside the vessel, offering a sutureless, fully absorbable solution for structural heart and endovascular procedures. In 2025, Vivasure submitted a Premarket Approval application to the U.S. Food and Drug Administration for the PerQseal Elite arterial closure system and received CE Mark approval in Europe for both arterial and venous indications. Results from the prospective, single-arm, multi-center ELITE arterial study demonstrated ease of use with no need for pre-close, with 0% major complications at 30-day follow-up, and immediate median time to hemostasis.1,2 David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed, who also served as an active board observer of Vivasure stated, “Vivasure has been a strategic holding since the formation of Orchestra BioMed, and we have been active and intentional in supporting the company for many years. We are very proud of the outstanding clinical results from the PerQseal product platform which we believe clearly positions it as a best-in-class solution for large diameter percutaneous vessel closure. This transaction represents a clear realization of our preferred approach to device development, powered by long-term, strategically aligned partnerships. We wish Haemonetics every success as it takes PerQseal forward commercially.” Andrew Glass, Chief Executive Officer of Vivasure Medical Limited commented, “Orchestra BioMed has been a deeply engaged partner since the earliest days of Vivasure. Their co-founders helped to lead our initial financing and supported the development of our PerQseal technology from concept stage. With Orchestra BioMed CEO, David Hochman, serving as an active board observer since 2019, and COO, Darren Sherman as an original board member through 2016, their strategic insight and guidance contributed meaningfully to the development of our product and its evolution to this next chapter.” “We recognize and appreciate the meaningful role Orchestra BioMed played as a long-term strategic partner in the development of Vivasure,” said Rajeev Varma, Senior Vice President, Strategy and Corporate Development of Haemonetics. “Vivasure has built a clinically differentiated closure device technology with PerQseal Elite, supported by strong clinical performance and safety data, representing a compelling opportunity to strengthen our impact in the large-bore closure market and structural heart and endovascular procedures.” About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates – Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) – are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designation for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind 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 ISR, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. About HaemoneticsHaemonetics is a global medical technology company dedicated to improving the quality, effectiveness and efficiency of health care. Haemonetics innovative solutions addressing critical medical needs include a suite of hospital technologies designed to advance standards of care and help enhance outcomes for patients; end-to-end plasma collection technologies to optimize operations for plasma centers; and products to enable blood centers to collect in-demand blood components. To learn more about Haemonetics, visit www.haemonetics.com. About Vivasure Medical LimitedBased in Galway, Ireland, Vivasure is focused on the development of advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility. PerQseal and PerQseal Elite are not available for sale in the United States. For more information, please visit www.vivasuremedical.com. Forward-Looking StatementsCertain 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 results of the acquisition of Vivasure by Haemonetics including the proceeds expected to be received by the Company pursuant to the achievement of certain milestones. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 31, 2025 and the risk factor discussed under the heading “Item 1A. Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, which was filed with the SEC on May 12, 2025. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor Contact:Silas NewcombOrchestra BioMedSnewcomb@orchestrabiomed.com Media Contact:Kelsey Kirk-EllisOrchestra BioMedkkirkellis@orchestrabiomed.com References Miegham, First in man use of the Vivasure PerQseal® Elite for large hole arterial closure, PCR London Valves Meeting 2024.Miegham, First in Man (FIM) Experience of the Vivasure PerQseal® ELITE System for Large Hole Closure: The ELITE and ELITE Venous Studies, Transcatheter Cardiovascular Therapeutics Meeting 2024.
Orchestra BioMed Announces AVIM Therapy and Virtue SAB Program Presentations at ICI Meeting
Joint presentation by Orchestra BioMed and Medtronic leadership to discuss ongoing strategic collaboration for development and commercialization of AVIM Therapy for treatment of uncontrolled hypertension in patients indicated for a pacemaker NEW HOPE, Pa., Dec. 08, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced three presentations at the 2025 Innovation in Cardiology Intervention (“ICI”) meeting in Tel Aviv, Israel, including two presentations focused on Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) and one focused on Virtue® Sirolimus AngioInfusion™ Balloon (“Virtue SAB”). The AVIM Therapy presentations will highlight the structure and operational strength of the Company’s strategic collaboration with Medtronic, plc (NYSE: MDT, “Medtronic”), as well as the therapy’s potential clinical utility in hypertensive heart disease. The Power of Partnerships: Orchestra BioMed and Medtronic’s Collaboration to Advance AVIM Therapy to Patients, presented by David Hochman, Chairman and Chief Executive Officer of Orchestra Biomed and Robert C. Kowal, M.D., Ph.D., Vice President and General Manager of Cardiac Pacing Therapies within the Medtronic Cardiac Rhythm Management operating unit (December 9, 2025; 14:00 IST / 07:00 AM EST)AVIM Therapy for the Treatment of Hypertensive Heart Disease, presented by Avi Fischer, M.D., Senior Vice President of Medical Affairs and Innovation, Orchestra Biomed (December 8, 2025; 15:12 IST / 08:12 AM EST) The Virtue SAB presentation will provide insights into the novel design of this first non-coated drug delivery system for coronary artery disease treatment, as well as the Virtue IDE trial focused on coronary in-stent restenosis. Virtue SAB and the Virtue Trial: A Next-Generation, Non-Coated Sirolimus-Eluting AngioInfusion Balloon and IDE Coronary ISR Trial vs. AGENT PCB, presented Bill Little, Executive Vice President of Corporate Development and Strategy (December 8, 2025; 14:00 JST / 07:00 AM EST) About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates – Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) – are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designation for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind drug delivery angioplasty balloon system designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. About AVIM Therapy AVIM Therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM Therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM Therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study 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 Breakthrough Device Designation by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk. About Virtue SAB Virtue SAB is a highly differentiated, first-of-its-kind drug delivery angioplasty balloon system designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™. It uses a non-coated microporous AngioInfusion™ Balloon to protect the drug in transit and consistently deliver a large liquid dose, overcoming certain limitations of drug-coated balloons. SirolimusEFR delivered by Virtue SAB has been shown in published preclinical series involving hundreds of arterial deliveries to achieve sustained tissue levels well above the known required therapeutic tissue concentration for inhibiting restenosis (1 ng/mg tissue) for the entire critical healing period of approximately 30 days. Virtue SAB demonstrated positive three-year clinical data in coronary ISR in the SABRE study, a multi-center, prospective, independent core lab-adjudicated clinical study of 50 patients conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee. Investor Contact:Silas NewcombOrchestra BioMedSnewcomb@orchestrabiomed.com Media Contact:Kelsey Kirk-EllisOrchestra BioMedkkirkellis@orchestrabiomed.com
Orchestra BioMed Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
NEW HOPE, Pa., Nov. 26, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, reported today that, on November 24, 2025, the Compensation Committee of the Orchestra BioMed Board of Directors granted stock options to purchase an aggregate of 151,250 shares of the Company’s common stock to 12 newly hired employees. The awards were granted pursuant to the Orchestra Biomed Holdings, Inc. 2025 New Hire Inducement Plan as an inducement material to each new employee entering employment with Orchestra Biomed, in accordance with Nasdaq Listing Rule 5635(c)(4). Twenty-five percent of the stock options granted to each new employee will vest on the first anniversary of the date such employee commenced employment with the Company, with the remainder vesting ratably each quarter over the following three-year period. Orchestra Biomed is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4). About Orchestra BioMedOrchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates – Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) – are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designation for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind drug delivery angioplasty balloon system designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. Investor Contact:Silas NewcombOrchestra BioMedSnewcomb@orchestrabiomed.com Media Contact:Kelsey Kirk-EllisOrchestra BioMedkkirkellis@orchestrabiomed.com
Orchestra BioMed Reports Third Quarter 2025 Financial Results and Highlights Recent Business Updates
Secured $147.6 million in proceeds and committed capital following completion of strategic transactions and concurrent public and private equity offerings, led by $71.6 million in committed capital from Medtronic and Ligand, as well as $30 million from TerumoInitiated patient enrollments in the Virtue Trial evaluating Virtue® Sirolimus AngioInfusion™ Balloon (“Virtue SAB”) trial versus commercially available paclitaxel-coated balloon Demonstrated partnership-driven business model execution with expanded strategic collaboration with Medtronic and new right of first refusal agreement with Terumo NEW HOPE, Pa., Nov. 10, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced financial results for the third quarter ended September 30, 2025, and provided a business update highlighting recent financial and regulatory milestones. Q3 2025 and Recent Business Highlights: Completed multiple strategic transactions and concurrent public and private equity offerings totaling $147.6 million in gross proceeds to support continued advancement of the Company’s pivotal trial-stage Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) and Virtue SAB clinical programs. Gross proceeds are comprised of: $55 million received or to be received by May 1, 2026, subject to certain conditions, in strategic investments from Ligand Pharmaceuticals Incorporated (Nasdaq: LGND, “Ligand”) and Medtronic, plc (NYSE: MDT, “Medtronic”)$62.6 million received from a $46 million oversubscribed, underwritten public offering of common stock and prefunded warrants and $11.6 million and $5 million received from private placements of common stock to Medtronic and Ligand, respectively$30 million received from Terumo Corporation, including a $10 million payment in exchange for granting Terumo a right of first refusal (“ROFR”) and a $20 million purchase of non-voting preferred stock, convertible into common stock at a minimum of $12 per share (the “Preferred Stock”) Extended cash runway into Q4 2027, supporting potentially significant value-creating catalysts, including: BACKBEAT study enrollment completion in mid-2026Follow up for the BACKBEAT study primary endpoint dataCompletion of enrollment of the Virtue Trial (as defined below) in mid-2027 Initiated patient enrollments in the Virtue SAB U.S. pivotal trial, a randomized head-to-head IDE registrational clinical trial comparing Virtue SAB with the commercially available AGENT™ DCB paclitaxel-coated balloon for the treatment of coronary in-stent restenosis (the “Virtue Trial”). Target completion of enrollment is expected in mid-2027.Entered into new strategic rights agreement with Terumo, superseding prior agreement which is now terminated, and providing Terumo with a ROFR with respect to certain strategic transactions relating to Virtue SAB for the treatment of coronary artery disease. Orchestra BioMed retains all development and distribution rights for Virtue SAB across all indications and has strategic optionality to explore potential transactionsOrchestra BioMed is sponsoring and in full operational control of the Virtue TrialOrchestra BioMed received $30 million for granting the ROFR and selling Terumo the Preferred Stock in additional payments on top of the prior $30 million payment and $5 million equity investment Expanded strategic collaboration with Medtronic, providing pathway for future development of AVIM Therapy-enabled leadless pacemakers.Implemented FDA-approved BACKBEAT global pivotal study protocol enhancements, broadening patient enrollment criteria for a more than 24-fold increase in the potentially eligible patient pool. Chairman and Chief Executive Officer Commentary from David Hochman: Mr. Hochman stated: “The last several months have been a period of exceptional execution, during which we secured nearly $150 million in capital and committed capital, positioning Orchestra BioMed to advance both of our pivotal-stage, high-impact programs with full momentum. Enrollment is actively underway in our pivotal, registrational trials for both AVIM Therapy and Virtue SAB. We are proud to have achieved a favorable realignment with Terumo, expanded our collaboration with Medtronic, and secured significant additional funding on terms we believe are highly attractive for shareholders, including a new strategic financial partnership with Ligand. As a result, we are well-financed through key clinical and regulatory milestones. We believe 2026 will be a landmark year for Orchestra, with the target completion of enrollment in the BACKBEAT study and active execution of the Virtue Trial toward completion of enrollment in the Virtue Trial in 2027.” Financial Results for the Third Quarter Ended September 30, 2025 Cash and cash equivalents and Marketable securities totaled $95.8 million as of September 30, 2025. On November 7, 2025, we received $30.0 million pursuant to new strategic rights and Terumo stock purchase agreements. The Company has commitments from Ligand and Medtronic to receive a combined $35.0 million in additional proceeds on or before May 1, 2026, based on the terms of agreements with those parties.Net cash used in operating activities and for the purchase of fixed assets was $14.9 million during the third quarter of 2025, compared with $13.8 million for the third quarter in 2024, with the primary driver being increased research and development costs during the third quarter of 2025.Revenue for the third quarter of 2025 was $0.9 million, compared with $1.0 million for the third quarter in 2024.Research and development expenses for the third quarter of 2025 were $14.0 million, compared with $11.6 million for the third quarter in 2024. The increase was primarily due to additional costs associated with the ongoing BACKBEAT global pivotal study.Selling, general and administrative expenses for the third quarter of 2025 were $7.1 million, compared with $5.7 million for the third quarter of 2024. The increase was primarily due to an increase in professional fees.Net loss for the third quarter of 2025 was $20.8 million, or $0.40 per share, compared with a net loss of $15.4 million, or $0.41 per share, for the third quarter of 2024. Net loss for the third quarter of 2025 included $3.0 million in non-cash stock-based compensation expense as compared to $2.4 million for the same period in 2024. About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates – Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) – are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic (NYSE: MDT), one of the largest medical device companies in the world, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designation for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind drug delivery angioplasty balloon system designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. References to Websites and Social Media Platforms References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release. About AVIM Therapy AVIM Therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM Therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM Therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will evaluate the safety and efficacy of AVIM Therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM Therapy has been granted Breakthrough Device Designation by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk. About Virtue SABVirtue SAB is a highly differentiated, first-of-its-kind drug delivery angioplasty balloon system designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™. It uses a non-coated microporous AngioInfusion™ Balloon to protect the drug in transit and consistently deliver a large liquid dose, overcoming certain limitations of drug-coated balloons. SirolimusEFR delivered by Virtue SAB has been shown in published preclinical series involving hundreds of arterial deliveries to achieve sustained tissue levels well above the known required therapeutic tissue concentration for inhibiting restenosis (1 ng/mg tissue) for the entire critical healing period of approximately 30 days. Virtue SAB demonstrated positive three-year clinical data in coronary ISR in the SABRE study, a multi-center, prospective, independent core lab-adjudicated clinical study of 50 patients conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the initiation, enrollment, timing, implementation and design of the Company’s ongoing pivotal trials, including the timing of completion of enrollment in the BACKBEAT study and the Virtue Trial, the receipt of committed capital, the Company’s expected cash runway, realizing the clinical and commercial value of AVIM Therapy and Virtue SAB, the potential safety and efficacy of the Company’s product candidates, and the ability of the Company’s partnerships to accelerate clinical development. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 31, 2025 and the risk factor discussed under the heading “Item 1A. Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, which was filed with the SEC on May 12, 2025. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor ContactSilas NewcombOrchestra BioMed Snewcomb@orchestrabiomed.com Media ContactKelsey Kirk-EllisOrchestra BioMedKkirkellis@orchestrabiomed.com Condensed Consolidated Balance Sheets(in thousands, except share and per share data)(Unaudited) September 30, December 31, 2025 2024 ASSETS CURRENT ASSETS: Cash and cash equivalents $42,012 $22,261 Marketable securities 53,808 44,551 Accounts receivable, net 52 92 Inventory 365 173 Prepaid expenses and other current assets 1,531 2,094 Total current assets 97,768 69,171 Property and equipment, net 1,595 1,384 Right-of-use assets 1,653 2,103 Strategic investments, less current portion 2,495 2,495 Deposits and other assets 1,296 1,020 TOTAL ASSETS $104,807 $76,173 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Accounts payable $8,473 $5,134 Accrued expenses and other liabilities 6,837 6,084 Operating lease liability, current portion 696 550 Deferred revenue, current portion 4,649 4,439 Total current liabilities 20,655 16,207 Deferred revenue, less current portion 8,659 10,989 Royalty purchase agreement 16,167 – Loan payable 14,204 14,292 Operating lease liability, less current portion 1,135 1,687 Other long-term liabilities 248 40 TOTAL LIABILITIES 61,068 43,215 STOCKHOLDERS’ EQUITY Preferred stock, $0.0001 par value per share; 10,000,000 shares authorized; none issued or outstanding at September 30, 2025 and December 31, 2024. – – Common stock, $0.0001 par value per share; 340,000,000 shares authorized; 56,464,731 and 38,194,442 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively. 6 4 Additional paid-in capital 412,512 342,780 Accumulated other comprehensive income 45 52 Accumulated deficit (368,824) (309,878)TOTAL STOCKHOLDERS’ EQUITY 43,739 32,958 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $104,807 $76,173 ORCHESTRA BIOMED HOLDINGS, INC.Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share data)(Unaudited) Three Months Ended September 30, 2025 2024 Revenue: Partnership revenue $721 $803 Product revenue 140 184 Total revenue 861 987 Expenses: Cost of product revenues 49 68 Research and development 14,027 11,595 Selling, general and administrative 7,098 5,666 Total expenses 21,174 17,329 Loss from operations (20,313) (16,342)Other (expense) income: Interest (expense) income, net (515) 916 Total other (expense) income (515) 916 Net loss $(20,828) $(15,426)Net loss per share Basic and diluted $(0.40) $(0.41)Weighted-average shares used in computing net loss per share, basic and diluted 52,186,503 37,621,495 Comprehensive loss Net loss $(20,828) $(15,426)Unrealized gain on marketable securities 29 121 Comprehensive loss $(20,799) $(15,305)
Orchestra BioMed to Host Business Update Call on November 12, 2025
NEW HOPE, Pa., Nov. 03, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, today announced that company management will host a business update call on Wednesday, November 12th at 8:00 AM ET. The business update will focus on recent significant clinical, strategic and financing developments, including the Company’s additional strategic investment from and collaboration expansion with Medtronic, its new strategic capital relationship with Ligand, its new right of first refusal agreement with Terumo, acceleration of enrollment in the BACKBEAT pivotal study of AVIM Therapy, the initiation of patient enrollment in the Virtue SAB US pivotal IDE coronary trial. Conference Call DetailsWednesday, November 12, at 8:00 AM Eastern Time Toll Free: 877-407-9039International: 201-689-8470Conference ID: 13756518Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1738644&tp_key=c80bc7995c About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates – Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) – are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic (NYSE: MDT), one of the largest medical device companies in the world, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designation for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind drug delivery angioplasty balloon system designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. Investor Contact:Silas NewcombOrchestra BioMedSnewcomb@orchestrabiomed.com Media Contact:Kelsey Kirk-EllisOrchestra BioMedkkirkellis@orchestrabiomed.com



