OBIO

The BACKBEAT global pivotal trial (“BACKBEAT Trial”), conducted in collaboration with Medtronic, is on track to reach its target of 284 evaluable randomized patients by end of Q3 2026, with primary data presentation targeted for Q2 2027, assuming those endpoints are met. Virtue pivotal trial is advancing with further site activations and patient enrollments. $110 million cash balance provides projected runway into Q4 2027 and through key upcoming milestones, following $35 million in strategic capital from Medtronic and Ligand. Company to host R&D Day on November 12, 2026, in New York City, featuring in-depth reviews of both the AVIM Therapy and Virtue SAB programs. NEW HOPE, Pa., Aug. 10, 2026 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced financial results for the second quarter ended June 30, 2026, and provided a business update on its two pivotal-stage cardiovascular programs: Atrioventricular Interval Modulation Therapy ("AVIM Therapy") for the treatment of uncontrolled hypertension in pacemaker-indicated patients, being developed in strategic collaboration with Medtronic (NYSE: MDT), and Virtue® Sirolimus AngioInfusion™ Balloon ("Virtue SAB") for the treatment of coronary in-stent restenosis. David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed, stated, "The second quarter brought clarity on both the timeline and the scope of the AVIM Therapy opportunity that we are pursuing with Medtronic. We remain on track to reach or exceed our target of 284 evaluable randomized patients in the BACKBEAT Trial by the end of the third quarter of 2026 and maintain our objective to present primary endpoint data as a major conference late-breaker in the second quarter of 2027. The second FDA Breakthrough Device Designation for AVIM Therapy earned during the second quarter strengthens potential regulatory and reimbursement upside for this high-impact program.” Hochman continued, "Our conviction that Virtue SAB offers distinctive potential clinical advantages because of its differentiated approach to arterial drug delivery continues to grow as we advance site activations and patient enrollment for the Virtue pivotal trial. With a $110 million cash balance at quarter-end following $35 million received from Medtronic and Ligand during the quarter, both pivotal programs are funded through their next major milestones. We are excited to review each in detail at our R&D Day in November." Q2 2026 and Recent Business Highlights: BACKBEAT Trial is on track to reach target of 284 evaluable randomized patients by end of Q3 2026. Assuming primary endpoints are met, Orchestra BioMed and Medtronic intend to submit primary endpoint data as a late-breaking clinical trial presentation at a major cardiovascular conference in the second quarter of 2027, followed by marketing application submissions to the FDA and global regulatory agencies. Received $35 million in strategic capital under previously disclosed agreements with Medtronic and Ligand (Nasdaq: LGND). Including this most recent investment, Medtronic’s total capital contribution to Orchestra BioMed is nearly $82 million. Ligand has now provided $40 million in total capital to the Company. FDA granted AVIM Therapy a second FDA Breakthrough Device Designation (“BDD”) specific to patients with uncontrolled hypertension despite anti-hypertensive medication who are indicated for a pacemaker. Together, AVIM Therapy’s two BDDs now cover both the broad group of patients with uncontrolled hypertension and elevated cardiovascular risk and the pacemaker-indicated group studied in the BACKBEAT Trial. Advanced site activation and patient enrollment in the Virtue SAB in the Treatment of Coronary In-Stent Restenosis (“ISR”) Trial (“Virtue Trial”), a multi-center, prospective, randomized head-to-head IDE registrational clinical trial comparing Virtue SAB with the commercially available AGENT™ paclitaxel-coated balloon for the treatment of coronary in-stent restenosis. Added to the Russell 3000® and Russell 2000® Indexes. Effective after the U.S. market close on June 26, 2026, Orchestra BioMed joined the broad-market Russell 3000® Index and the small-cap Russell 2000® Index at the conclusion of the 2026 Russell indexes reconstitution, broadening the Company's visibility among institutional investors and index funds benchmarked to the Russell indexes. R&D Day: November 12, 2026The Company will host an R&D Day on November 12, 2026 in New York City. The event will feature presentations from management and leading physician investigators covering the AVIM Therapy and Virtue SAB programs, including recent program and pipeline developments. Additional details, including registration and webcast information, will be announced in the future. Financial Results for the Second Quarter Ended June 30, 2026 Cash and cash equivalents and Marketable securities totaled $110.0 million as of June 30, 2026. Net cash used in operating activities and for the purchase of fixed assets was $19.6 million during the second quarter of 2026, compared with $15.6 million for the second quarter in 2025, with the primary drivers being increased research and development costs, including clinical trial activities, as well as personnel and consulting expenditures during the second quarter of 2026. Research and development expenses for the second quarter of 2026 were $16.6 million, compared with $13.9 million for the second quarter in 2025, which represents an increase of 20%. The increase was primarily due to additional costs associated with the ongoing BACKBEAT Trial and to advance the Virtue SAB program, including the Virtue Trial. Selling, general and administrative expenses for the second quarter of 2026 were $5.8 million, compared with $6.3 million for the second quarter of 2025, which represents a decrease of 7%. The decrease was primarily due to a decrease in stock-based compensation expense. Net loss attributable to common stockholders for the second quarter of 2026 was $24.1 million, or ($0.38) per share, compared with a net loss attributable to common stockholders of $19.4 million, or ($0.50) per share, for the second quarter of 2025, which represents an increase of 23%. Net loss attributable to common stockholders for the second quarter of 2026 included $2.7 million in interest expense for the second quarter of 2026 as compared to $0.5 million for the same period in 2025, of which a portion was non-cash in the current period. Non-cash stock-based compensation expense was $2.5 million as compared to $3.2 million for the same period in 2025. About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates - Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) - are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered by a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic (NYSE: MDT), one of the largest medical device companies in the world and a global leader in cardiac pacing therapies, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designations for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind non-coated drug delivery angioplasty balloon system designed to deliver a large liquid dose of proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary in-stent restenosis, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. About AVIM Therapy AVIM Therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM Therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM Therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal trial is evaluating the safety and efficacy of AVIM Therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM Therapy has been granted two Breakthrough Device Designations by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk. About Virtue SAB Virtue SAB is designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™ through a non-coated microporous AngioInfusion™ Balloon that protects the drug in transit to consistently deliver a large liquid dose overcoming certain limitations of drug-coated balloons. SirolimusEFR delivered by Virtue SAB has been shown in published preclinical series involving hundreds of arterial deliveries to achieve sustained tissue levels well above the known required therapeutic tissue concentration for inhibiting restenosis (1 ng/mg tissue) for the entire critical healing period of approximately 30 days. Virtue SAB demonstrated positive three-year clinical data in coronary ISR in the SABRE study, a multi-center prospective, independent core lab-adjudicated pilot clinical study of 50 patients conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for specific indications relating to coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the enrollment, timing, implementation, results and design of the Company’s ongoing pivotal trials, the timing of the presentation of clinical data, the timing of regulatory submissions, realizing the clinical and commercial value of AVIM Therapy and Virtue SAB, the potential safety and efficacy of the Company’s product candidates, the potential benefits of Breakthrough Device Designation, the ability of the Company’s partnerships to accelerate clinical development and the Company’s projected cash runway. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on March 12, 2026. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor Contact:Silas NewcombOrchestra [email protected] Media Contact:Nina PremuticoOrchestra [email protected]

Orchestra BioMed targeting enrollment completion of BACKBEAT Global Pivotal Trial (“BACKBEAT Trial”) by the end of Q3 2026 Medtronic (NYSE: MDT) and Orchestra BioMed intend to pursue late-breaking clinical trial presentation at major cardiology conference in Q2 2027 and subsequent marketing application submission to FDA and global regulatory agencies, assuming primary endpoints are met FDA 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 Virtue Trial sites progressing with site activation and patient enrollment acceleration continuing throughout 2026 Cash runway projected into Q4 2027 and through achievement of key upcoming clinical and regulatory milestones NEW HOPE, Pa., May 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 risk-reward sharing partnerships, today announced financial results for the first quarter ended March 31, 2026, and provided a business update highlighting momentum across the Company’s pivotal-stage programs for Atrioventricular Interval Modulation (“AVIM”) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (“Virtue SAB”) supported by the Company’s strong balance sheet. David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed stated, “We continued to make meaningful advancements across our late-stage cardiovascular pipeline during the first quarter. Along with the achievement of recently announced important regulatory, clinical and financing milestones, we are pleased to provide clarity on the expected timeline for the BACKBEAT Trial highlighting objectives for enrollment completion, late-breaking clinical trial presentation, and plans for potential regulatory submissions by our strategic collaborator Medtronic. With increasingly strong momentum continuing in the BACKBEAT Trial and the AVIM Therapy program, and great progress for the Virtue Trial and Virtue SAB, our team is excited about the significant value inflection points that lie ahead for Orchestra BioMed.” Q1 2026 and Recent Business Highlights: Provided overall update on the BACKBEAT Trial timeline, targeting enrollment completion by the end of the third quarter of 2026 and announced plans with Medtronic to pursue presentation of primary endpoint data as a late-breaking clinical trial presentation at a major cardiovascular conference in the second quarter of 2027, assuming primary endpoints are met. The updated timeline is supported by FDA approval of a reduction in sample size for the BACKBEAT Trial to a target total of 284 evaluable randomized subjects, with a total enrollment target of 316 patients accounting for potential loss to follow-up. FDA granted AVIM Therapy a second FDA Breakthrough Device Designation (“BDD”) specific to patients with uncontrolled hypertension despite the use of anti-hypertensive medications, and an indication for a pacemaker. The BDDs granted to AVIM Therapy collectively apply to 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 Trial, representing a U.S. population of over 7.7 million patients. BDD can support enhanced reimbursement pathways, including potential eligibility for New Technology Add-on Payment and Transitional Pass-Through payment, which can facilitate broader, more timely patient access and provider adoption. Received $35 million in strategic capital under previously disclosed agreements with Medtronic and Ligand (Nasdaq: LGND). Received $20 million from Medtronic as payment for a secured subordinated promissory note convertible to capped prepaid revenue share, fulfilling Medtronic’s previously disclosed funding commitment. This brings Medtronic’s total capital contribution to Orchestra BioMed to nearly $82 million including prior equity investments, supporting the planned completion of the BACKBEAT Trial. Received $15 million tranche payment from Ligand associated with the previously disclosed Royalty Purchase Agreement, bringing total capital received from Ligand to $40 million to date in exchange for tiered royalty interest in certain future AVIM Therapy and Virtue SAB revenue, as well as an equity investment. Presented AVIM Therapy clinical and mechanistic data at HRS 2026, including pre-randomization data from the MODERATO II pilot study in which AVIM Therapy demonstrated a mean immediate reduction in office systolic blood pressure of 13.2 mmHg upon activation, with 97% of patients achieving a 5 mmHg or greater blood pressure reduction upon AVIM Therapy activation. Advanced site activation and patient enrollment in the Virtue Trial, a multi-center, prospective, randomized head-to-head IDE registrational clinical trial comparing Virtue SAB with the commercially available AGENT™ paclitaxel-coated balloon for the treatment of coronary in-stent restenosis. Financial Results for the First Quarter Ended March 31, 2026 Cash and cash equivalents and Marketable securities totaled $94.4 million as of March 31, 2026. On May 1, 2026, we received $35 million, which includes $20 million from Medtronic and $15 million from Ligand pursuant to the terms of agreements with those parties. Net cash used in operating activities and for the purchase of fixed assets was $22.4 million during the first quarter of 2026, compared with $16.7 million for the first quarter in 2025, with the primary drivers being increased research and development costs, including clinical trial activities, as well as personnel and consulting expenditures, which include non-recurring payments, during the first quarter of 2026. Revenue for the first quarter of 2026 was $0.1 million, compared with $0.9 million for the first quarter in 2025. The decrease was primarily due to the elimination of recognized revenue from our prior distribution agreement with Terumo, which was terminated in October 2025. Research and development expenses for the first quarter of 2026 were $15.8 million, compared with $13.5 million for the first quarter in 2025, which represents an increase of 17%. The increase was primarily due to additional costs associated with the ongoing BACKBEAT Trial and to advance the Virtue SAB program, including the Virtue Trial. Selling, general and administrative expenses for the first quarter of 2026 were $6.4 million, compared with $6.3 million for the first quarter of 2025, which represents an increase of 2%. The increase was primarily due to an increase in professional fees. Net loss attributable to common stockholders for the first quarter of 2026 was $20.7 million, or ($0.33) per share, compared with a net loss attributable to common stockholders of $18.8 million, or ($0.49) per share, for the first quarter of 2025, which represents an increase of 10%. Net loss attributable to common stockholders for the first quarter of 2026 included $2.9 million in non-cash stock-based compensation expense as compared to $3.0 million for the same period in 2025. About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates - Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) - are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered by a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic, 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 Therapy AVIM Therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM Therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM Therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal trial is evaluating the safety and efficacy of AVIM Therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM Therapy has been granted two Breakthrough Device Designations by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk. About Virtue SAB Virtue SAB is designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™ through a non-coated microporous AngioInfusion™ Balloon that protects the drug in transit to consistently deliver a large liquid dose overcoming certain limitations of drug-coated balloons. SirolimusEFR delivered by Virtue SAB has been shown in published preclinical series involving hundreds of arterial deliveries to achieve sustained tissue levels well above the known required therapeutic tissue concentration for inhibiting restenosis (1 ng/mg tissue) for the entire critical healing period of approximately 30 days. Virtue SAB demonstrated positive three-year clinical data in coronary ISR in the SABRE study, a multi-center prospective, independent core lab-adjudicated pilot clinical study of 50 patients conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for specific indications relating to coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the enrollment, timing, implementation, results and design of the Company’s ongoing pivotal trials, the timing of the presentation of clinical data, the timing of regulatory submissions, realizing the clinical and commercial value of AVIM Therapy and Virtue SAB, the potential safety and efficacy of the Company’s product candidates, the potential benefits of Breakthrough Device Designation, the ability of the Company’s partnerships to accelerate clinical development and the Company’s projected cash runway. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on March 12, 2026. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor Contact: Silas Newcomb Orchestra BioMed [email protected] Media Contact: Kelsey Kirk Orchestra BioMed [email protected]

Codexis (CDXS) came out with quarterly earnings of $0.11 per share, beating the Zacks Consensus Estimate of $0.01 per share. This compares to a loss of $0.13 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +2,100.00%. A quarter ago, it was expected that this producer of custom industrial enzymes would post a loss of $0.15 per share when it actually produced a loss of $0.22, delivering a surprise of -46.67%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Codexis, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $38.92 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 1.61%. This compares to year-ago revenues of $21.46 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Codexis shares have lost about 23.9% since the beginning of the year versus the S&P 500's decline of 0.9%. While Codexis has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Codexis was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.02 on $19.02 million in revenues for the coming quarter and -$0.33 on $70.17 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 42% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Orchestra BioMed Holdings, Inc. (OBIO), another stock in the same industry, has yet to report results for the quarter ended December 2025. This company is expected to post quarterly loss of $0.38 per share in its upcoming report, which represents a year-over-year change of +11.6%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Orchestra BioMed Holdings, Inc.'s revenues are expected to be $0.79 million, up 216% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Codexis, Inc. (CDXS) : Free Stock Analysis Report Orchestra BioMed Holdings, Inc. (OBIO) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Orchestra BioMed Holdings, Inc. (OBIO) came out with quarterly earnings of $0.26 per share, beating the Zacks Consensus Estimate of a loss of $0.38 per share. This compares to a loss of $0.43 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +168.87%. A quarter ago, it was expected that this company would post a loss of $0.38 per share when it actually produced a loss of $0.4, delivering a surprise of -5.26%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Orchestra BioMed Holdings, Inc., which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $30.92 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 3,813.54%. This compares to year-ago revenues of $0.25 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Orchestra BioMed Holdings, Inc. shares have added about 10.8% since the beginning of the year versus the S&P 500's decline of 1%. While Orchestra BioMed Holdings, Inc. has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Orchestra BioMed Holdings, Inc. was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.42 on $0.78 million in revenues for the coming quarter and -$1.58 on $3.28 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 36% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Stoke Therapeutics, Inc. (STOK), is yet to report results for the quarter ended December 2025. This company is expected to post quarterly loss of $0.75 per share in its upcoming report, which represents a year-over-year change of -316.7%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Stoke Therapeutics, Inc.'s revenues are expected to be $5.5 million, down 75.7% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Orchestra BioMed Holdings, Inc. (OBIO) : Free Stock Analysis Report Stoke Therapeutics, Inc. (STOK) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

$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 2025 Strong 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 Newcomb Orchestra BioMed [email protected] Media Contact: Kelsey Kirk-Ellis Orchestra BioMed [email protected]

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 Terumo Initiated 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-2026 Follow up for the BACKBEAT study primary endpoint data Completion 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 transactions Orchestra BioMed is sponsoring and in full operational control of the Virtue Trial Orchestra 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 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. 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 Contact Silas Newcomb Orchestra BioMed [email protected] Media Contact Kelsey Kirk-Ellis Orchestra BioMed [email protected]

Orchestra BioMed Holdings, Inc. (OBIO) is expected to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended September 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This company is expected to post quarterly loss of $0.38 per share in its upcoming report, which represents a year-over-year change of +7.3%. Revenues are expected to be $0.75 million, down 24.2% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 17.71% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Orchestra BioMed Holdings, Inc., the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +7.90%. On the other hand, the stock currently carries a Zacks Rank of #2. So, this combination indicates that Orchestra BioMed Holdings, Inc. will most likely beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Orchestra BioMed Holdings, Inc. would post a loss of$0.51 per share when it actually produced a loss of -$0.50, delivering a surprise of +1.96%. Over the last four quarters, the company has beaten consensus EPS estimates two times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Orchestra BioMed Holdings, Inc. appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Among the stocks in the Zacks Medical - Biomedical and Genetics industry, Zymeworks Inc. (ZYME), is soon expected to post loss of $0.3 per share for the quarter ended September 2025. This estimate indicates a year-over-year change of +23.1%. This quarter's revenue is expected to be $28.27 million, up 76.7% from the year-ago quarter. Over the last 30 days, the consensus EPS estimate for Zymeworks has been revised 24.9% up to the current level. Nevertheless, the company now has an Earnings ESP of +15.00%, reflecting a higher Most Accurate Estimate. This Earnings ESP, combined with its Zacks Rank #3 (Hold), suggests that Zymeworks will most likely beat the consensus EPS estimate. The company beat consensus EPS estimates in each of the trailing four quarters. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Orchestra BioMed Holdings, Inc. (OBIO) : Free Stock Analysis Report Zymeworks Inc. (ZYME) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Secured over $111 million in proceeds and committed capital following completion of strategic transactions and concurrent public and private equity offerings, led by over $71 million in committed capital from Medtronic and Ligand Achieved multiple FDA regulatory milestones: Breakthrough Device Designation for AVIM therapy; approval for expanded BACKBEAT study enrollment criteria, and IDE approval for a U.S. pivotal Virtue SAB trial versus commercially available paclitaxel-coated balloon NEW HOPE, Pa., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced financial results for the second quarter ended June 30, 2025, and provided a business update highlighting recent financial and regulatory milestones. Q2 2025 and Recent Business Highlights: Completed multiple strategic transactions and concurrent public and private equity offerings totaling an expected $111.2 million in gross proceeds to support continued advancement of the Company’s late-stage atrioventricular interval modulation (“AVIM”) therapy and Virtue Sirolimus AngioInfusion Balloon (“SAB”) clinical programs. Gross proceeds are comprised of: $55 million received or to be received by May 1, 2026, subject to certain conditions, from royalty-based, non-dilutive investments from Ligand Pharmaceuticals Incorporated (Nasdaq: LGND, “Ligand”) and Medtronic, plc (NYSE: MDT, “Medtronic”) Ligand committed $35 million in exchange for a tiered revenue interest in Orchestra BioMed’s future royalties from AVIM therapy and Virtue SAB Medtronic committed $20 million in exchange for a secured subordinated promissory note convertible to capped prepaid revenue share $56.2 million received from a $40 million underwritten public offering of common stock and prefunded warrants and $11.2 million and $5 million received from private placements of common stock to Medtronic and Ligand, respectively Proceeds expected to extend cash runway into the second half of 2027, supporting potentially significant value-creating catalysts, including: BACKBEAT study enrollment completion in mid-2026 BACKBEAT study primary endpoint data Substantial enrollment of the Virtue Trial Medtronic and Orchestra BioMed expanded strategic collaboration to provide pathway for future development of AVIM therapy-enabled leadless pacemakers. U.S. Food and Drug Administration (“FDA”) Breakthrough Device Designation (“BDD”) granted for atrioventricular interval modulation (“AVIM”) therapy in patients with uncontrolled hypertension and increased cardiovascular risk, marking a major regulatory validation of the therapy's potential to improve hypertensive heart disease outcomes. FDA-approved updated BACKBEAT study protocol now being implemented, broadening patient enrollment criteria for a more than 24-fold increase in the potentially eligible patient pool; full implementation to be completed in Q4 2025. FDA Investigational Device Exemption (“IDE”) Approval received for the Virtue SAB U.S. pivotal trial, a randomized head-to-head study comparing Virtue SAB with the commercially available AGENT™ DCB paclitaxel-coated balloon (the “Virtue Trial”). Trial initiation is currently targeted for the second half of 2025. Orchestra BioMed is sponsoring and in full operational control of the Virtue Trial; mediation with Terumo of certain other contractual terms is progressing, with conclusion of formal mediation process expected in Q3 2025. Intellectual Property Expansion continued with AVIM therapy patent estate reaching 137 issued patents worldwide, with recent additions bolstering coverage for both hypertension and heart failure indications. Chairman and Chief Executive Officer (“CEO”) Commentary from David Hochman: Mr. Hochman stated: “The successful completion of strategic financing transactions with Medtronic and Ligand, along with closing our first underwritten public offering are expected to give us up to $111 million in new capital to support execution of both AVIM therapy and Virtue SAB pivotal clinical studies. Our entire organization is focused on our mission to bring these high-impact, innovative, device-based therapies to market.” Mr. Hochman continued: “We were also proud to have achieved multiple key regulatory milestones for both AVIM therapy and Virtue SAB in the second quarter. The FDA Breakthrough Device Designation awarded to AVIM therapy for the treatment of uncontrolled hypertension in patients with increased cardiovascular risk has potentially significant implications to future regulatory submissions and opens up potential pathways for enhanced reimbursement for AVIM therapy-enabled devices. The FDA also approved an important update to the BACKBEAT study protocol that we are now rolling out to study centers that significantly expands eligibility criteria for enrollment and supports our enrollment completion objectives for next year. Finally, FDA approval of the updated IDE for our head-to-head pivotal trial comparing Virtue SAB to commercially available AGENT paclitaxel-coated balloon marks another significant regulatory milestone. These achievements will help us in our continued efforts to reshape clinical standards of care in both hypertensive heart disease and atherosclerotic artery disease.” Financial Results for the Second Quarter Ended June 30, 2025 Cash and cash equivalents and Marketable securities totaled $33.9 million as of June 30, 2025. Combined with net proceeds received from recent financing transactions, estimated Cash and cash equivalents and Marketable securities position was $101 million as of August 12, 2025. The Company has commitments from Ligand and Medtronic to receive a combined $35 million in additional proceeds on or before May 1, 2026, based on the terms of agreements with those parties. Net cash used in operating activities and for the purchase of fixed assets was $15.6 million during the second quarter of 2025, compared with $10.3 million for the second quarter in 2024, with the primary driver being increased research and development costs during the second quarter of 2025. Revenue for the second quarter of 2025 was $0.8 million, compared with $0.8 million for the second quarter in 2024. Research and development expenses for the second quarter of 2025 were $13.9 million, compared with $11.1 million for the second quarter in 2024. The increase was primarily due to additional costs associated with the ongoing BACKBEAT global pivotal study. Selling, general and administrative expenses for the second quarter of 2025 were $6.3 million, compared with $6.5 million for the second quarter of 2024. The decrease was primarily due to a decrease in professional fees. Net loss for the second quarter of 2025 was $19.4 million, or $0.50 per share, compared with a net loss of $16.0 million, or $0.45 per share, for the second quarter of 2024. Net loss for the second quarter of 2025 included $3.2 million in non-cash stock-based compensation expense as compared to $2.8 million for the same period in 2024. About Orchestra BioMed Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s lead product candidate is AVIM therapy for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed is also developing Virtue SAB for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. The Company has received four Breakthrough Device Designations from the U.S. FDA across these two core programs, reflecting the significant potential of its technologies to address high unmet needs in cardiovascular care. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. References to Websites and Social Media Platforms References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release. About AVIM Therapy AVIM therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will evaluate the safety and efficacy of AVIM therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM therapy has been granted Breakthrough Device Designation by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk. About Virtue SAB Virtue SAB is an investigational therapeutic combination drug-device designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™ through a non-coated microporous AngioInfusion™ Balloon, protecting the drug in transit through the arteries and consistently delivering a large liquid dose, overcoming certain limitations of drug-coated balloons. SirolimusEFR delivered by Virtue SAB has been shown in published preclinical series involving hundreds of arterial deliveries to achieve sustained tissue levels well above the known required therapeutic tissue concentration for inhibiting restenosis (1 ng/mg tissue) for the entire critical healing period of approximately 30 days. Virtue SAB demonstrated positive three-year clinical data in coronary in-stent restenosis (“ISR”) in the SABRE study, a multi-center prospective, independent core lab-adjudicated clinical study conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for specific indications relating to coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee. The FDA granted IDE approval for Orchestra BioMed to evaluate the efficacy and safety of Virtue SAB in the Virtue Trial, a pivotal trial that will randomize Virtue SAB against commercially available AGENT™ DCB, a paclitaxel-coated balloon. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the initiation, enrollment, timing, implementation and design of the Company’s planned and ongoing pivotal trials, including the timing of completion of enrollment in the BACKBEAT study and the timing of initiation of the Virtue Trial, the receipt of committed capital, the Company’s expected cash runway, the date of completion of the formal mediation with Terumo, the potential benefits of BDD, realizing the clinical and commercial value of AVIM therapy and Virtue SAB, the potential safety and efficacy of the Company’s product candidates, and the ability of the Company’s partnerships to accelerate clinical development. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 31, 2025 and the risk factor discussed under the heading “Item 1A. Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, which was filed with the SEC on May 12, 2025. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor Contact Silas Newcomb Orchestra BioMed [email protected] Media Contact Kelsey Kirk-Ellis Orchestra BioMed [email protected]

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 (NYSE: 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® 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 Virtue SAB is an investigational therapeutic combination drug-device designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™ through a non-coated microporous AngioInfusion™ Balloon, protecting the drug in transit through the arteries and consistently delivering a large liquid dose, overcoming certain limitations of drug-coated balloons. SirolimusEFR delivered by Virtue SAB has been shown in published preclinical series involving hundreds of arterial deliveries to achieve sustained tissue levels well above the known required therapeutic tissue concentration for inhibiting restenosis (1 ng/mg tissue) for the entire critical healing period of approximately 30 days. Virtue SAB demonstrated positive three-year clinical data in coronary in-stent restenosis (“ISR”) in the SABRE study, a multi-center prospective, independent core lab-adjudicated clinical study conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for specific indications relating to coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee. The FDA granted IDE approval for Orchestra BioMed to evaluate the efficacy and safety of Virtue SAB in the Virtue Trial, a pivotal trial that will randomize Virtue SAB against commercially available AGENTTM DCB, a paclitaxel-coated balloon. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the initiation, enrollment, timing, implementation and design of the Company’s planned and ongoing pivotal trials and reporting of top-line results, including the timing of initiation of the Virtue Trial, the potential benefits of BDD, including its ability to expedite FDA reviews and allow access to add-on reimbursement, 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 Newcomb Orchestra BioMed [email protected] Media Contact Kelsey Kirk-Ellis Orchestra BioMed [email protected]

The market expects Orchestra BioMed Holdings, Inc. (OBIO) to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This company is expected to post quarterly loss of $0.46 per share in its upcoming report, which represents a year-over-year change of -21.1%. Revenues are expected to be $0.39 million, down 37.1% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 1.03% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Orchestra BioMed Holdings, Inc.The Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +1.64%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination indicates that Orchestra BioMed Holdings, Inc. Will most likely beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Orchestra BioMed Holdings, Inc. Would post a loss of $0.43 per share when it actually produced a loss of $0.43, delivering no surprise. Over the last four quarters, the company has beaten consensus EPS estimates two times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Orchestra BioMed Holdings, Inc. Appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Intellia Therapeutics, Inc. (NTLA), another stock in the Zacks Medical - Biomedical and Genetics industry, is expected to report earnings per share of $1.26 for the quarter ended March 2025. This estimate points to a year-over-year change of -18.9%. Revenues for the quarter are expected to be $14.5 million, down 49.9% from the year-ago quarter. Over the last 30 days, the consensus EPS estimate for Intellia Therapeutics has been revised 0.8% up to the current level. Nevertheless, the company now has an Earnings ESP of -4.93%, reflecting a lower Most Accurate Estimate. When combined with a Zacks Rank of #2 (Buy), this Earnings ESP makes it difficult to conclusively predict that Intellia Therapeutics will beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates three times. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Orchestra BioMed Holdings, Inc. (OBIO) : Free Stock Analysis Report Intellia Therapeutics, Inc. (NTLA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

NEW HOPE, Pa., March 31, 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 reported its full year 2024 financial results and provided a fourth quarter business update. "We remain highly focused on execution of the BACKBEAT global pivotal study, which we believe has the potential to deliver landmark results that can establish AVIM therapy as a new standard of care for the treatment of uncontrolled hypertension in patients already indicated for a pacemaker. We also believe it can lay the foundation for expanding use of AVIM-enabled devices to manage blood pressure and improve cardiovascular function for hypertensive patients with high cardiovascular risk,” commented David Hochman, Chairman, Chief Executive Officer and Founder of Orchestra BioMed. “As we age, our arteries naturally lose elasticity and become stiffer, a process that increases the risk of cardiovascular problems and is linked to changes in blood pressure and heart function. One of the characteristics of this process is the development of diastolic dysfunction, a condition where the heart's ventricles cannot relax and fill with blood properly during the diastolic phase of the cardiac cycle. Our late-breaking data in patients with diastolic dysfunction recently presented at THT showed AVIM therapy’s ability to significantly improve ventricular relaxation and passive filling, highlighting its potential to drive better clinical outcomes through blood pressure reduction, as well as improvement of cardiac function." “In parallel, we are encouraged by the progress of our Virtue SAB program as we actively prepare to initiate a U.S. coronary pivotal study with an updated trial design, currently under FDA review. The study is expected to randomize patients with coronary in-stent restenosis to treatment with Virtue SAB or Boston Scientific’s AGENT drug-coated balloon. We believe this design will optimally highlight the potential advantages of Virtue SAB’s proprietary design advantages which enables protected delivery of extended focal-release sirolimus without the need for a balloon coating,” continued Mr. Hochman. “With regard to our strategic partnership, we and Terumo are moving our negotiations into a formal mediation process. We believe this is the most efficient way to drive our relationship to a resolution, ideally during the second quarter of this year, ahead of potential initiation of the updated Virtue ISR-US pivotal study in the second half of the year.” Fourth Quarter 2024 and Recent Highlights Continued site activation and patient enrollment of the BACKBEAT global pivotal study, in collaboration with Medtronic (NYSE: MDT), evaluating the efficacy and safety of atrioventricular interval modulation (“AVIM”) therapy in hypertensive pacemaker patients. Submitted a revised design to the U.S. Food and Drug Administration (“FDA”) for the Virtue ISR-US pivotal study in coronary in-stent restenosis (“ISR”), which will randomize Virtue® Sirolimus AngioInfusion™ Balloon (“SAB”) against Boston Scientific’s AGENT drug-coated balloon; initiation is targeted for the second half of 2025, pending FDA approval of an amended investigational device exemption (“IDE”) which is expected to be secured in the second quarter of 2025. To accelerate potential completion of ongoing partnership restructuring negotiations, Orchestra BioMed and Terumo have elected to enter a mediation process and are currently working on a procedural plan that would aim to conclude the mediation process in the second quarter of 2025. Enhanced board of directors with the appointment of three highly experienced independent directors: Christopher Cleary, former Senior Vice President of Corporate Development at Medtronic, where he played a key role in establishing the strategic collaboration between Orchestra BioMed and Medtronic for AVIM therapy John Mack, former President of Cardiac Surgery at Medtronic with extensive operational and strategic experience in the medical device industry David Pacitti, Chief Executive Officer of Avanos Medical, former President of Siemens Medical Solutions USA, Inc. and Head of the Americas, Siemens Healthineers, with nearly 30 years of experience in cardiovascular device and procedural imaging Strengthened senior leadership team with the appointment of Mark Pomeranz as Executive Vice President & General Manager, Interventional Therapies. Mr. Pomeranz has over two decades of experience in medical devices, with particular emphasis on cardiology and gastrointestinal verticals. He most recently served as Chief Executive Officer of Motus GI Holdings. Financial Results for the Year Ended December 31, 2024 Cash and cash equivalents and Marketable securities totaled $66.8 million as of December 31, 2024. During the year, our cash inflows included approximately $15.0 million in net cash proceeds from the sale of our Common Stock under a market sales agreement and approximately $15.0 million from the initial draw on our credit facility. Net cash used in operating activities and for the purchase of fixed assets was $50.8 million during 2024, compared with $46.2 million for 2023, with the primary driver of this increase being increased cash outflows for research and development during 2024. Revenue for 2024 was $2.6 million, compared with $2.8 million for 2023. The decrease was primarily due to decreased recognition of partnership revenues earned under the agreement with Terumo. Research and development expenses for 2024 were $42.8 million, compared with $33.8 million for 2023. The increase was primarily due to additional costs associated with the ongoing BACKBEAT global pivotal study. Selling, general and administrative expenses for 2024 were $23.9 million, compared with $20.3 million for 2023. The increase was primarily due to increased expenses related to stock-based stock compensation. Net loss for 2024 was $61.0 million, or ($1.66) per share, compared with a net loss of $49.1 million, or ($1.48) per share, for 2023. Net loss for the year-ended 2024 included non-cash stock-based compensation expense of $10.6 million, compared with $7.6 million for the same period in 2023. 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 atrioventricular interval modulation (AVIM) therapy (also known as BackBeat Cardiac Neuromodulation Therapy (CNT™)) for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed is also developing the Virtue® Sirolimus AngioInfusion™ Balloon (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. 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, also known as BackBeat CNT™, 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. 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 a similar target population of patients who have been indicated for, and recently implanted with, a dual-chamber cardiac pacemaker. About Virtue SAB Virtue SAB is a patented drug/device combination product candidate in development for the treatment of certain forms of artery disease that is designed to deliver a proprietary, investigational, extended-release formulation of sirolimus, SirolimusEFR™, to the vessel wall during balloon angioplasty without any coating on the balloon surface or the need to leave a stent or other permanent implant in the artery. 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 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. Orchestra BioMed has a strategic partnership with Terumo (Terumo, TSE: 4543), a global leader in medical technology headquartered in Tokyo, Japan, as well as Terumo Medical Corporation, its U.S. subsidiary, to collaborate on the global development and commercialization of Virtue SAB in coronary and peripheral vascular indications. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the initiation, enrollment, timing, implementation and design of the Company’s planned and ongoing pivotal trials and reporting of top-line results, realizing the clinical and commercial value of BackBeat CNT and Virtue SAB, the Company’s ability to conclude the mediation process with Terumo in the second quarter of 2025, and the potential safety and efficacy of the Company’s product candidates. 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 Securities and Exchange Commission (“SEC”) on March 31, 2025, and under the heading “Item1A. Risk Factors” in Part II of the Company’s subsequently filed quarterly reports on Form 10-Q. 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: Jeremy Feffer LifeSci Advisors [email protected] Media Contact: Kelsey Kirk-Ellis Orchestra BioMed (484) 682-4892 [email protected]