Orchestra BioMed Reports First Quarter 2025 Financial Results and Highlights Recent Regulatory and Clinical Milestones

   -- FDA Breakthrough Device Designation Awarded to AVIM Therapy 
 
   -- FDA IDE Approved for Virtue SAB U.S. Pivotal Trial for Launch 

NEW HOPE, Pa., May 12, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, "Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced financial results for the first quarter ended March 31, 2025, and provided a business update highlighting continued regulatory momentum, disciplined operational execution, and a strengthening clinical development pipeline.

Q1 2025 Highlights:

   -- U.S. Food and Drug Administration ("FDA") Breakthrough Device Designation 
      ("BDD") granted for atrioventricular interval modulation ("AVIM") therapy 
      in patients with uncontrolled hypertension and increased cardiovascular 
      risk, with or without an indication for a pacemaker, marking a major 
      regulatory validation of the therapy's potential to improve hypertensive 
      heart disease outcomes. FDA BDD enables prioritized regulatory 
      interactions and strengthens potential access to add-on reimbursement. 
 
   -- BACKBEAT Global Pivotal Study execution continuing to progress in 
      strategic collaboration with Medtronic $(MDT)$. 
 
   -- New Clinical Data presented demonstrating the favorable impact of AVIM 
      therapy on cardiac function in patients with diastolic dysfunction, a key 
      contributor to the development of heart failure, as late breaker at THT 
      2025. 
 
   -- Intellectual Property Expansion continues with AVIM therapy patent estate 
      reaching 137 issued patents worldwide, with recent additions bolstering 
      coverage for both hypertension and heart failure indications. 
 
   -- FDA Investigational Device Exemption ("IDE") Approval received for the 
      Virtue$(R)$ Sirolimus AngioInfusion Balloon ("SAB") U.S. pivotal trial, a 
      randomized head-to-head study comparing Virtue SAB with the commercially 
      available AGENTTM DCB paclitaxel-coated balloon (the "Virtue Trial"). 
      Trial initiation is currently targeted for the second half of 2025. 
 
          -- Orchestra BioMed is sponsoring and in full operational control of 
             the Virtue Trial; mediation with Terumo of certain other 
             contractual terms is progressing. 

Key Chief Executive Officer ("CEO") Commentary:

David Hochman, Chairman and CEO of Orchestra BioMed, stated: "We continued to make meaningful progress during the first quarter with significant inflection points for both our AVIM therapy and Virtue SAB programs. We believe the FDA's Breakthrough Device Designation for AVIM therapy signals meaningful recognition of its potential to meet the clinical needs of millions living with hypertensive heart disease, a population in which chronic high blood pressure can lead to various heart problems like left ventricular hypertrophy, diastolic dysfunction, heart failure, and coronary artery disease. We believe that AVIM therapy has the potential to provide a potent additional therapeutic option for these patients. We are focused on execution of the BACKBEAT global pivotal study alongside our strategic partner Medtronic as the critical pathway toward making AVIM therapy available to patients globally."

Mr. Hochman continued, "In parallel, we secured full IDE approval to conduct the Virtue Trial, a U.S. pivotal coronary study that will evaluate Virtue SAB, our investigational, non-coated drug-eluting balloon designed to deliver a large liquid dose of proprietary extended-release sirolimus, head-to-head against the commercially available AGENT paclitaxel-coated balloon. We believe the updated design of the trial, which we currently plan to initiate in the second half of the year, offers the most direct path to regulatory approval while showcasing the distinctive pharmacokinetic and therapeutic advantages of our proprietary technology. Taken together, these milestones mark tangible progress on multiple fronts. We continue to execute methodically and remain focused on advancing our pivotal trials, generating clinical evidence, and building long-term value for patients, physicians, shareholders and strategic partners alike."

Financial Results for the First Quarter Ended March 31, 2025

   -- Cash and cash equivalents and Marketable securities totaled $49.9 million 
      as of March 31, 2025. 
 
   -- Net cash used in operating activities and for the purchase of fixed 
      assets was $16.7 million during the first quarter of 2025, compared with 
      $13.1 million for the first quarter in 2024, with the primary driver 
      being increased research and development costs during the first quarter 
      of 2025. 
 
   -- Revenue for the first quarter of 2025 was $0.9 million, compared with 
      $0.6 million for the first quarter in 2024. The increase was primarily 
      due to recognition of partnership revenues earned under the agreement 
      with Terumo. 
 
   -- Research and development expenses for the first quarter of 2025 were 
      $13.5 million, compared with $9.1 million for the first 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 first quarter of 
      2025 were $6.3 million, compared with $5.9 million for the first quarter 
      of 2024. The increase was primarily due to an increase in stock-based 
      compensation and increased professional fees associated with the overall 
      growth of the business. 
 
   -- Net loss for the first quarter of 2025 was $18.8 million, or $0.49 per 
      share, compared with a net loss of $13.5 million, or $0.38 per share, for 
      the first quarter of 2024. Net loss for the first quarter of 2025 
      included $3.0 million in non-cash stock-based compensation expense as 
      compared to $2.6 million for the same period in 2024. 

About Orchestra BioMed

Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed's partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed's lead product candidate is AVIM therapy for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed is also developing Virtue SAB for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. The Company has received four Breakthrough Device Designations from the U.S. FDA across these two core programs, reflecting the significant potential of its technologies to address high unmet needs in cardiovascular care. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn.

References to Websites and Social Media Platforms

References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release.

About AVIM Therapy

AVIM therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will further evaluate the safety and efficacy of AVIM therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM therapy has been granted Breakthrough Device Designation by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk.

About Virtue SAB

(MORE TO FOLLOW) Dow Jones Newswires

May 12, 2025 16:28 ET (20:28 GMT)