8-K
Orchestra BioMed Holdings, Inc. (OBIO)
8-K
2025-10-30
For: 2025-10-30
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April 06, 2026
UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549
FORM 8-K
CURRENT REPORT PURSUANT TO SECTION 13OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): October 30, 2025
ORCHESTRA BIOMED
HOLDINGS, INC. (Exact name of registrant as specified in its charter)
| Delaware(State or other jurisdictionof incorporation) | 001-39421(CommissionFile Number) | 92-2038755(IRS EmployerIdentification No.) |
|---|---|---|
| 150 Union Square DriveNew Hope, Pennsylvania 18938(Address of principal executive offices, including zip code)Registrant’s telephone number, including area code: (215) 862-5797(Former name or former address, if changed since last report) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities<br>Act (17 CFR 230.425) |
|---|---|
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange<br>Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under<br>the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under<br>the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common stock, par value $0.0001 per share | OBIO | The Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
| Item 7.01. | Regulation FD Disclosure. |
|---|
A copy of a slide presentation that Orchestra BioMed Holdings, Inc. (the “Company”) uses at investor and industry conferences and presentations is attached to this Current Report on Form 8-K (“Current Report”) as Exhibit 99.1 and is incorporated herein solely for purposes of this Item 7.01 disclosure. Additionally, the Company has posted the slide presentation on its website at https://investors.orchestrabiomed.com under the Investor Relations section.
The information in Item 7.01 of this Current Report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such section. The information in Item 7.01 of this Current Report, including Exhibit 99.1, shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any incorporation by reference language in any such filing.
| Item 9.01. | Financial Statements and Exhibits. |
|---|
(d) Exhibits.
| Exhibit Number | Description |
|---|---|
| 99.1 | Investor Presentation. |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained<br> in Exhibit 101). |
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ORCHESTRA BIOMED HOLDINGS, INC. | ||
|---|---|---|
| By: | /s/ Andrew Taylor | |
| Name: | Andrew Taylor | |
| Title: | Chief Financial Officer | |
| Date: October 30, 2025 |
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Exhibit 99.1
| Orchestra<br>BioMed<br>Corporate<br>Overview<br>October 2025<br>Nasdaq: OBIO | |
|---|---|
| Forward-Looking Statements<br>This presentation has been prepared for informational purposes only from information<br>supplied by Orchestra BioMed Holdings, Inc., referred to herein as “we,” “our,”<br>“Orchestra BioMed,” and “the Company,” and from third-party sources indicated<br>herein. Such third-party information has not been independently verified. Orchestra<br>BioMed makes no representation or warranty, expressed or implied, as to the accuracy<br>or completeness of such information.<br>Certain statements included in this document that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States<br>Private Securities Litigation Reform Act of 1995. Forward-looking statements generally<br>are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,”<br>“anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,”<br>“seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate<br>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 potential<br>safety and efficacy of our product candidates, the initiation, enrollment and timing of<br>our planned pivotal trials and reporting of top-line results, expected market sizes for<br>our product candidates, the ability of our partnerships to accelerate clinical<br>development and the benefits of Breakthrough Device Designation. These statements<br>are based on various assumptions, whether or not identified in this document, and<br>on the current expectations of the Company’s management and are not<br>predictions of actual performance. These forward-looking statements are provided<br>for illustrative purposes only and are not intended to serve as and must not be<br>relied on as a guarantee, an<br>assurance, a prediction, or a definitive statement of fact or probability. Actual events<br>and circumstances are difficult or impossible to predict and may differ from<br>assumptions. Many actual events and circumstances are beyond the control of the<br>Company. These forward-looking statements are subject to a number of risks and<br>uncertainties, including changes in domestic and foreign business, market, financial,<br>political, and legal conditions; risks related to regulatory approval of the Company’s<br>product candidates; the timing of, and the Company’s ability to achieve expected<br>regulatory and business milestones; the impact of competitive products and product<br>candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in<br>the Company’s annual report on Form 10-K filed with the U.S. Securities and Exchange<br>Commission on March 31, 2025 as updated by any risk factors disclosed under the<br>heading “Item 1A. Risk Factors” in Part II of the Company’s subsequently filed quarterly<br>reports on Form 10-Q.<br>The Company operates in a very competitive and rapidly changing environment. New<br>risks emerge from time to time. Given these risks and uncertainties, the Company<br>cautions against placing undue reliance on these forward-looking statements, which<br>only speak as of the date of this presentation. The Company does not plan and<br>undertakes no obligation to update any of the forward-looking statements made<br>herein, except asrequired by law.<br>2 | Corporate Overview October 2025 |
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| AVIM Therapy<br>Programmable, pacemaker-delivered<br>treatment for high blood pressure and<br>hypertensive heart disease<br>Virtue SAB<br>Proprietary, non-coated sirolimus balloon<br>angioplasty system for atherosclerotic artery<br>disease and other indications<br>Key Investment Highlights<br>Leveraging Partnerships to Bring Innovation to Patients & Yield Exceptional Future Profitability<br>Pivotal Stage, High-Impact Therapies<br>Large, Established<br>Target Markets<br>Strategic collaboration Partnership-Enabled<br>Business Model<br>Funded Through<br>Key Milestones<br>3 | Corporate Overview October 2025<br>Strategic rights agreement<br>Hypertensive Heart Disease:<br>>$17B annual global opportunity<br>Atherosclerotic Artery Disease:<br>>$10B annual global opportunity<br>$31.6 million committed by<br>Double-digit revenue share Right of First Refusal in coronary market<br>$147M+ in new capital raised since August 2025, led by strategic investments:<br>$40 million committed by<br>BACKBEAT Study enrollment completion &<br>primary results readout<br>Expected cash runway through key milestones into Q4 2027 including:<br>Virtue Trial enrollment completion<br>$30 million committed by |
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| Expert Leadership, Proven Impact<br>300+<br>Combined years in<br>the industry<br>experience<br>25+<br>Average years of<br>experience,<br>bringing deep<br>expertise to every<br>challenge<br>100+<br>Successful product<br>approvals, delivering<br>innovation globally<br>600+<br>Authored patents<br>shaping the future of<br>healthcare<br>Our leadership team is highly experienced, has a successful track record of bringing high-impact medical<br>technologies to market, and includes individuals who have worked together for years<br>Independent Board Members<br>Jason Aryeh Pamela Connealy Chris Cleary Eric S. Fain, M.D. David Pacitti John Mack<br>4 | Corporate Overview October 2025 |
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| Target Disease Program Target Population Preclinical Clinical<br>Feasibility<br>Clinical<br>Pivotal<br>Hypertensive Heart<br>Disease<br>Atrioventricular<br>Interval<br>Modulation<br>(AVIM) Therapy<br>Hypertension (HTN) & Pacemaker<br>HTN with Increased CV Risk<br>(Non-pacemaker indicated)<br>HTN & Heart Failure<br>AVIM/Cardiac Neuromodulation Therapy may have additional clinical application in advanced heart failure.<br>Atherosclerotic Artery<br>Disease<br>Virtue®<br>Sirolimus<br>AngioInfusion<br>Balloon (SAB)<br>Coronary In-Stent<br>Restenosis (ISR)<br>Coronary Small Vessel (SV)<br>Below-the-Knee (BTK)<br>Other Coronary & Peripheral<br>Indications<br>SirolimusEFR may have potential clinical application in a variety of non-vascular indications.<br>IDE Approved & FDA Breakthrough<br>FDA Breakthrough<br>BACKBEAT Global Pivotal Study Enrolling & FDA Breakthrough<br>FDA Breakthrough<br>Advancing High-Impact Pipeline*<br>Two Pivotal Trial Stage Programs with Significant Future Expansion Opportunities<br>FDA Breakthrough<br>*For more detailed information relating to our pipeline, please see the disclosure under “Item 1. Business” in our Form 10-K for the<br>year ended December 31, 2024 filed with the SEC on March 31, 2025. 5<br>FDA Breakthrough<br> | Corporate Overview October 2025<br>$17 Billion Annual Global Opportunity<br>$10 Billion Annual Global Opportunity |
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| Over $147M in Strategic-Driven Financing Secured Since August 2025<br>$85M of Strategic Capital Commitments + $62.6M Equity Financing Expected to Provide Runway into Q4 2027<br>$35 million committed to purchase royalty-based revenue<br>interest; plus $5 million equity investment<br>$31.6 million additional strategic investment commitment<br>brings total investment amount to $81.6 million<br>Ligand’s long-term capital commitment is tied to<br>commercial success and reflects Orchestra’s significant<br>future royalty-based revenue opportunity<br>Collaboration expansion provides potential development<br>pathway for future AVIM-enabled leadless pacemaker<br>integration<br>Established biopharma investor with tiered royalty interest<br>in Orchestra’s future AVIM Therapy and Virtue SAB<br>revenues<br>Global market leader in cardiac pacing therapy and<br>existing collaborator for AVIM Therapy program<br>6 | Corporate Overview October 2025<br>$30 million total payments associated with new strategic rights agreements |
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| Atrioventricular<br>Interval Modulation<br>(AVIM) therapy<br>Also known as BackBeat CNT<br>7 | Corporate Overview October 2025 |
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| AVIM Therapy Overview<br>Hypertension is the leading global risk factor for death, affecting 1.2B patients<br>Uncontrolled HTN in older, higher-risk patients drives MI, stroke and heart failure<br>Reductions as small as 5 mmHg in office systolic blood pressure substantially decrease<br>the relative risk of major cardiovascular events and conditions<br>A Purpose-Built Solution for HTN Patients with Increased Risk in $17B Market<br>Patented therapy delivered as firmware enhancement to pacemaker<br>Designed to drive immediate, substantial and sustained blood pressure reduction<br>Robust body of clinical and mechanistic data<br>Initial target is pacemaker population, where HTN is the #1 comorbidity<br>Potential to expand to millions of HTN patients with increased CV risk<br>Potential benefit in HFpEF prevention and treatment<br>FDA Breakthrough Designation for Beachhead Market and Beyond<br>Novel, Programmable, Always-On Therapy<br>Collaboration with<br>8 | Corporate Overview October 2025 |
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| $17 Billion<br>Annual Global<br>Opportunity<br>Highly Selected Target Patient Population for AVIM Represents Large<br>Global Opportunity Leveraging Existing Reimbursement Pathways*<br>HTN & Pacemaker<br>~70% of pacemaker patients1<br>750,000<br>highly addressable patients<br>>$2 Billion<br>HTN with Increased CV Risk / HFpEF<br>~0.3% of HTN patients<br>3,700,000<br>highly addressable patients<br>>$15 Billion<br>Same patients, device implant, and<br>treating physicians<br>Existing reimbursement structure<br>Older patients with uncontrolled<br>hypertension and significant comorbidities<br>Similar demographics to pacemaker patients,<br>increased cardiovascular risk, difficult-to-treat<br>*Total addressable market in 2025 based on company estimates<br>1Company estimates based on published sources, including National Inpatient Survey (NIS) and National<br>Health and Nutrition Examination Survey (NHANES); Definition: Hypertension (HTN)<br>9 | Corporate Overview October 2025 |
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| Developed AVIM Therapy from concept stage<br>Owns all related intellectual property: 120 issued global patents<br>related to hypertension<br>Conducted all prior development and the MODERATO I & II<br>clinical studies<br>Sponsor for the BACKBEAT Global Pivotal Study<br>Global market leader in cardiac pacing therapy: >$2B in annual<br>revenues<br>Integrated AVIM Therapy for download into premium commercial<br>pacemakers for the BACKBEAT study<br>Exclusive global commercial rights for pacemaker-indicated HTN<br>patients; recent expansion for future leadless pacemakers<br>Right of first negotiation to expand global rights for the treatment<br>of non-pacemaker patients with HTN<br>1 Amount is based on higher of (1) a fixed dollar amount per device (amount varies materially on a country-by-county basis)<br>or (2) a percentage of sales<br>AVIM Therapy Strategic Collaboration with Medtronic<br>$61.6M equity investment plus<br>$20 million strategic capital commitment<br>$500 - $1,600 revenue share per AVIM-enabled<br>device assuming existing reimbursement structures1<br>10 | Corporate Overview October 2025 |
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| AVIM Therapy is a Novel Investigational Treatment for Hypertension<br>AVIM On<br>Systolic BP (mmHg)<br>Short AV intervals: Reduce cardiac preload, immediately<br>lowering blood pressure<br>Intermittent longer AV intervals: modulate autonomic nervous<br>system response (baroceptor reflex) and reduce afterload (total<br>peripheral resistance), sustaining blood pressure reduction<br>AVIM Off<br>1Kalarus et al. Journal of the American Heart Association.<br>2021;10:e020492ahajournals.org/doi/10.1161/JAHA.120.020492. 2Kuck, Hemodynamics Effects of AVIM Therapy,<br>Technology and Heart Failure Therapeutics Meeting 2024 Definitions: AV (Atrioventricular), RV (Right Ventricular)<br>Novel & Potent Mechanism<br>Independent of lead position: compatible with traditional RV<br>pacing or conduction system pacing<br>30 Sec<br>Utilizes well-characterized physiologic mechanisms (Frank-Starling)<br>to favorably impact circulatory hemodynamics2<br>:<br>• Reduces intra-cardiac volumes and pressures<br>• Improves cardiovascular efficiency<br>• No adverse impact on contractility<br>Designed to Have an Immediate, Substantial, and Sustained Effect1<br>11 | Corporate Overview October 2025 |
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| Substantial -11.1 mmHg Reduction<br>in 24-Hour aSBP at 6 months<br>Sustained -17.5 mmHg Reduction<br>in oSBP at 2 years<br>0% Major Adverse Cardiac Events<br>vs. 14.3% in control group at 6 months4<br>AVIM Therapy showed<br>encouraging results in<br>MODERATO II, a<br>prospective, multi-center,<br>randomized, controlled,<br>double-blind, pilot study of<br>pacemaker patients with<br>uncontrolled hypertension<br>despite medical therapy1,2<br>MODERATO II Randomized, Double-Blind Results<br>Significant Reduction in Systolic Blood Pressure (SBP)<br>Control (n=20)3<br>AVIM Therapy (n=26)<br>6 Months 24 Months<br>24-Hour Ambulatory SBP (aSBP) Office SBP (oSBP)<br>6 Months<br>0<br>-5<br>-10<br>-15<br>-20<br>-11.1<br>P < 0.001 -12.4<br>P < 0.001<br>-0.1<br>P = 0.94<br>-17.5<br>P < 0.01<br>Δ in BP (mmHg)<br>-3.1<br>P =0.17<br>-15.6 P < 0.001<br>-1.5<br>P = 0.5<br>1 day<br>Δ -14.1<br>p = 0.001<br>Δ -8.1<br>p = 0.01 Δ -12.3<br>p = 0.02<br>1Kalaras et al. Journal of the American Heart Association. 2021;10:e020492 ahajournals.org/doi/10.1161/JAHA.120.020492; 2Burkhoff MODERATO II Study 2-Year Results TCT 2021; 324-<br>Hr aSBP Control (n=19), 1 control patient could not be measured despite repeat measurement (patient had extremely high blood pressure); 4A blinded evaluation Data Safety<br>Monitoring Board report for MODERATO II included a revised MACE rate, from 9.5% to 14.3%, in the control group to reflect a heart failure after publication of the study results.<br>Definitions: Major Adverse Cardiac Events (MACE) included death, heart failure, clinically significant arrhythmias (i.e., persistent or increased atrial fibrillation, serious ventricular<br>arrhythmias), myocardial infarction, stroke and renal failure in treatment group calculated per patient.<br>12 | Corporate Overview October 2025 |
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| The BACKBEAT Study – Global Pivotal Hypertension Trial<br>Designed to Secure Regulatory Approval & Showcase Novel Approach to Blood Pressure Management<br>Primary Efficacy Endpoint: Mean change in 24-hour aSBP at 3-months<br>Primary Safety Endpoint: Freedom from unanticipated serious adverse device events at 3 months<br>Additional Secondary Endpoints: Efficacy and safety endpoints after 12-month follow-up<br>Option to crossover to open-label +24 months unblinded follow-up phase<br>Randomized,<br>prospective, multi-center, double-blind,<br>controlled trial<br>N=500; 130+ sites in U.S.<br>and EU<br>Estimated completion of<br>enrollment mid-2026<br>Patients previously implanted with or indicated for a Medtronic Astra or Azure<br>dual-chamber pacemaker who have hypertension despite 1-3 anti-HTN medications<br>AVIM Therapy<br>download & setup<br>R<br>AVIM Therapy +<br>Medical Therapy<br>Medical<br>Therapy<br>13 | Corporate Overview October 2025 |
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| Virtue® Sirolimus<br>AngioInfusion<br>Balloon (SAB)<br>14 | Corporate Overview October 2025 |
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| Virtue® SAB Overview<br>Drug-coated balloons (DCB) emerging as new standard of care for key coronary and peripheral indications<br>Boston Scientific’s AGENT Paclitaxel-coated balloon US commercialization underway with positive indications of sales<br>growth<br>Paradigm Shift Unlocks High-Growth Opportunity in Large $10B Established Market1<br>Virtue SAB is Designed to Redefine Arterial Drug Delivery with Significant Differentiation<br>1Total addressable market in 2025 based on company estimates. 2Verheye et al. JACC Cardiovasc Interv 2017 Oct<br>23;10(20):2029-2037. DOI: 10.1016/j.jcin.2017.06.021. 3Revised per protocol analysis set meets the criteria of the<br>proposed In-Stent Restenosis IDE study population. 4Granada 3-Year Clinical Results TCT 2018.<br>Proprietary SirolimusEFR extends release of therapeutic levels of “gold-standard” drug through critical healing period<br>Non-coated microporous balloon designed to protect drug in transit to consistently deliver large liquid dose<br>overcoming the limitations of drug-coated balloons<br>Best-in-class clinical data from SABRE pilot study shows promising and durable safety and efficacy in<br>coronary ISR, with 2.8% TLF at 1 year and 0% TLR between 1-3 years2,3,4<br>Near-term Planned U.S. IDE Pivotal Study and Robust Reimbursement Landscape<br>Orchestra BioMed sponsoring and in full operational control of planned Virtue US coronary<br>IDE trial randomizing 1:1 to Boston Scientific's AGENT PCB<br>Expected enhanced reimbursement supporting large commercial opportunity<br>15 | Corporate Overview October 2025 |
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| Large Global Opportunity for Virtue SAB*<br>Coronary<br>~3,700,000 patients<br>>$7.5 Billion<br>Peripheral<br>~1,250,000 patients<br>>$2.5 Billion<br>>$10 Billion<br>Annual Global<br>Opportunity<br>Large mature market with suboptimal treatments for coronary in-stent restenosis, coronary small vessel de novo and below-the-knee<br>Multibillion dollar established market for additional potential vascular indications<br>*Total addressable market in 2025 based on company estimates; Definitions: Coronary Artery<br>Disease (CAD), Peripheral Artery Disease (PAD) 16 | Corporate Overview October 2025 |
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| Compelling Opportunity For Virtue SAB<br>Coatings have challenges, such as limited dosing, risk of emboli from<br>large particulates, and drug loss in transit<br>A Novel Solution is Required to Realize Advantages of Sirolimus<br>1Xinlin Zhang, et. al. PLOS ONE 2014 May 20;9(5):e97934<br>Superiority of sirolimus safety and efficacy over paclitaxel demonstrated<br>in large meta-analysis of 76 drug-eluting stent studies including 26 RCTs1<br>Sirolimus requires extended release through the critical healing period<br>to achieve full benefits (~30 days of >1ng/mg tissue concentration)<br>Paclitaxel became “drug of choice” for coated balloons because it is<br>easier, not better (fast tissue absorption and long tissue retention)<br>+<br>Protected Delivery of<br>Extended Release Sirolimus<br>SirolimusEFR<br>Microporous AngioInfusion<br>Balloon<br>17 | Corporate Overview October 2025 |
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| Protected Delivery of<br>Extended Release Sirolimus<br>Virtue® SAB – Optimal Drug, Dose and Delivery<br>1Granada et al. EuroIntervention 2016;12:740-747. 2 Animals included in the analysis of distant organs<br>received average dose of 20.4 mg ≈10X the largest clinical dose<br>SirolimusEFR Microporous AngioInfusion Balloon<br>Large Liquid Dose Loaded and Protected in Dose Unit<br>Delivered Through the Micropores During Inflation<br>1000 NO coating = NO drug loss in transit, NO rush and NO large particulate<br>100<br>10<br>1<br>0.1<br>0.01<br>0.001<br>0.0001<br>2Lung, liver & kidney below level of assay<br>quantification (0.1 ng/mg) in <1 week<br>0 5 10 15 20 25 30<br>Target Lesion<br>Distal Myocardium<br>Kidney<br>Liver<br>Lung<br>Time (Days)<br>N = 753<br>porcine coronary artery segments<br>Sirolimus Tissue Concentration<br>(ng/mg)<br>Published Data Demonstrates Therapeutic Tissue<br>Concentrations Through Critical Healing Period (~30 Days)1<br>Required Therapeutic Concentration > 1ng/mg<br>18 | Corporate Overview October 2025 |
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| Low 2.8% Target Lesion Failure<br>(TLF) at 1 year<br>Low 0.12mm Late Lumen Loss<br>(LLL) at 6-months<br>0% Target Lesion Revascularization<br>(TLR) between 1-3 years<br>Virtue® SAB<br>demonstrated<br>encouraging safety<br>and efficacy results<br>in patients with<br>coronary in-stent<br>restenosis (ISR) in<br>prospective, multi-center SABRE Trial1,2,3<br>Compelling SABRE Trial Results in Coronary ISR Patients<br>Virtue SAB Low Event Rates Out to 3 Years<br>Single-Layer Restenosis<br>0%<br>5%<br>10%<br>15%<br>20%<br>25%<br>5.6%<br>2.8% 2.8% 2.8%<br>0% 0% 0% 0% 0% 0% 0%<br>2.8%<br>Cardiac Death TV-MI TLR TLF<br>Event Rates (%)<br>30 days<br>1-year<br>3-years<br>1Verheye et al. JACC Cardiovasc Interv 2017 Oct 23;10(20):2029-2037. DOI: 10.1016/j.jcin.2017.06.021. 2 Revised per protocol<br>analysis set meets the criteria of the proposed In-Stent Restenosis IDE study population. 3Granada 3-Year Clinical Results TCT 2018.<br>Definitions: Target lesion failure (TLF), late lumen loss (LLL), target lesion revascularization (TLR) and Myocardial Infarction (MI).<br>19 | Corporate Overview October 2025 |
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| Target Lesion Failure<br>13.5% (AGENT) and 13.2%<br>(SELUTION)<br>(TLF) at 1 year<br>No angiographic follow-up<br>in both IDE<br>AGENT LLL = 0.397mm at 6<br>months4; SELUTION LLL not<br>reported for coronary ISR<br>AGENT & SELUTION4ISR IDE Trial Results Show Clear<br>Opportunity for Virtue SAB<br>0%<br>5%<br>10%<br>15%<br>20%<br>25%<br>20.2%<br>13.5%<br>1 Year 2 Year<br>Event Rates (%)<br>AGENT<br>POBA<br>(n=341)<br>AGENT TLF Out to 2 years<br>Single-Layer Restenosis1,2<br>1Yeh RW, Shlofmitz R, Moses J, et al. JAMA. 2024;331(12):1015–1024. doi:10.1001/jama.2024.136. 2Moses, J Two-Year<br>Outcomes from the AGENT IDE Trial CRT 2025. 3Cutlip et al. SELUTION4ISR Clinical Trial TCT 2025. 4Boston Scientific AGENT<br>DCB Brochure 2017. Definitions: Plain old balloon angioplasty (POBA), Standard of care (SOC), late lumen loss (LLL)<br>26.6%<br>20.7%<br>AGENT 53% relative<br>increase in TLF<br>from 1 to 2 years<br>20 | Corporate Overview October 2025<br>0%<br>5%<br>10%<br>15%<br>20%<br>25%<br>13.2%<br>1 Year<br>Event Rates (%)<br>(n=167)<br>SELUTION TLF at 1 year<br>Single-Layer Restenosis3<br>SELUTION<br>SOC<br>10.0%<br>SOC<br>~80% DES<br>20% POBA<br>POBA POBA<br>Adapted from 2 separate IDE Trials |
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| The Virtue Trial – U.S. Randomized Pivotal Coronary ISR Trial<br>Designed to Secure Regulatory Approval & Showcase Differentiation of Virtue SAB<br>R<br>740 Pts with ISR Lesions in Arteries 2.00 – 4.00mm<br>Virtue Sirolimus<br>AngioInfusion<br>Balloon<br>1:1<br>370 Pts. 370 Pts.<br>12 M 12 M<br>Clinical Follow-Up out to 5 Years<br>Primary Endpoint: Target Lesion Failure (TLF) at 12 months<br>Primary analysis non-inferiority comparison<br>Additional superiority test performed upon confirming non-inferiority<br>AGENT<br>Paclitaxel Coated<br>Balloon<br>FDA IDE approved<br>1:1 RCT vs AGENT<br>N=740<br>Up to 75 US Sites<br>Primary endpoint 12-Month TLF<br>Planned initiation 2H 2025<br>21 | Corporate Overview October 2025 |
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| Orchestra developed Virtue SAB from concept stage, owns all related IP, conducted all prior studies, and<br>retains all development and distribution rights in all indications<br>Terumo is a global leader in interventional cardiology devices: >$2.4B in annual revenues1<br>Terumo purchased ROFR for Virtue SAB transactions with respect to the global coronary market<br>• Orchestra free to engage actively with all strategic parties and solicit proposals<br>• Terumo has 30 days following notice of a third-party proposal acceptable to Orchestra to exercise ROFR<br>• Expires 90 days after disclosure of primary endpoint data from the Virtue Trial<br>$65M in total payments and investments received over time from Terumo<br>• $10M paid in consideration of ROFR, plus $20M purchase of non-voting preferred with minimum $12/share conversion<br>after Virtue Trial results announced<br>• Initially paid $30M for Virtue SAB rights under original distribution agreement plus $5M equity investment<br>Terumo ROFR Agreement Highlights Strategic Interest & Optionality<br>ROFR = Right of First Refusal; 1 22 | Corporate Overview October 2025 Based on Terumo’s consolidated financial results for the fiscal year ended March 31, 2025. |
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| Pivotal Stage, High-Impact Therapies<br>Large, Established Target Markets<br>Partnership-Enabled Business Model<br>Expected Funding into Q4 2027<br>23 | Corporate Overview October 2025<br>Key Investment Highlights<br>Leveraging Partnerships to Bring Innovation to Patients & Yield Exceptional Future Profitability |
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| Bringing Medical<br>Innovations to Life<br>Through Partnerships | |
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