UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
|
| ||
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 Act (17 CFR 230.425) | |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| Pre-commencement communications pursuant to Rule 13e-4(c) under 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 |
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
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 |
Description |
| 99.1 | Investor Presentation. |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained 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/ David Hochman | |
| Name: David P. Hochman | ||
| Title: Chief Executive Officer | ||
| Date: June 8, 2023 | ||
3
Exhibit 99.1
Bringing medical inn vation to life Bringing medical inn vation to life Orchestra BioMed Corporate Presentation Q2 2023
Forward - Looking Statements 2 This presentation has been prepared for informational purposes only from information supplied by Orchestra BioMed Holdings, I nc. , referred to herein as “we,” “our,” “Orchestra BioMed,” and “the Company,” and from third - party sources indicated herein. Such third - party information has not been independently verified. Orchestra BioMed makes no representation or warranty, expressed or implied, as to the accuracy or com ple teness of such information. Certain statements included in this document that are not historical facts are forward - looking statements for purposes of the sa fe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward - looking statements generally are accompanied by word s such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “ see m,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Th ese forward - looking statements include, but are not limited to, statements relating to the potential safety and efficacy of our product candidates, the timi ng of our planned pivotal trials, expected market sizes for our product candidates, the ability of our partnerships to accelerate clinical development, and our es timated future financial performance and financial position. These statements are based on various assumptions, whether or not identified in this docu men t, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward - looking statements are pro vided 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 def ini tive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many act ual events and circumstances are beyond the control of the Company. These forward - looking statements are subject to a number of risks and uncertainties, incl uding changes in domestic and foreign business, market, financial, political, and legal conditions; failure to realize the anticipated benefit s o f the business combination; risks related to regulatory approval of the Company’s product candidates; the timing of, and the Company’s ability to achieve expec ted 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 quarterly report on Form 10 - Q filed with the U.S. Securities and Exchange Commission on May 12, 2023 as updated by any risk factors disclosed under the heading “Item 1A. Risk Factors” in 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 ris ks 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 requir ed by law.
Orchestra BioMed Executive Summary Strategic collaboration Double - digit revenue share Strong balance sheet and outstanding investors Partnership - enabled business model designed to accelerate innovation to patients, drive strong partner and shareholder value and yield exceptional future profitability Statistically significant double - blind, randomized preliminary trial efficacy data Plan to initiate p ivotal trial H2 2023 Strategic collaboration Double - digit revenue share Strong 3 - year multi - center preliminary trial safety and efficacy data Plan to initiate pivotal trial H2 2023 3 ĂĐŬĞĂƚ Ed Ρ ƚĂƌŐĞƚƐхΨ ϭϬ ĂŶŶƵĂůŚLJƉĞƌƚĞŶƐŝŽŶŵĂƌŬĞƚƐ &ŝƌŵǁĂƌĞƵƉŐƌĂĚĞƚŽĞdžŝƐƚŝŶŐ ƉĂĐĞŵĂŬĞƌ Virtue® SAB targets >$3B annual artery disease markets Protected sirolimus delivery, non - coated balloon
Enable new growth opportunities Outsource development Minimize P&L dilution 4 Orchestra BioMed’s Partnership - enabled Model Benefits All Development Strategic Partners Commercialization /ŵƉƌŽǀĞƉĂƚŝĞŶƚůŝǀĞƐ ĐĐĞůĞƌĂƚĞĚĞǀĞůŽƉŵĞŶƚ >ĞǀĞƌĂŐĞĞdžƉĞƌƚŝƐĞΘƌĞƐŽƵƌĐĞƐ Secure substantial long - term royalties Outsource commercialization Multiple pipeline opportunities Shared Benefits
Avi Fischer, M.D. SVP, Medical Affairs & Innovation J.C. Simeon SVP, Quality Inessa R. Wheeler VP, Marketing Bob Laughner VP, Regulatory Affairs Stephen A. Zielinski VP, Product Dev., Bioelectronic Therapies Ziv Belsky VP, Research, Bioelectronic Therapies Juan Lorenzo VP, Product Dev., Focal Therapies Highly Accomplished Executive Team & Board Executive Team: >250 Years of Experience, ~25 Avg Industry Years, >100 Product Approvals & >600 Authored Patents 5 ,ĂŶƐ Ͳ WĞƚĞƌ^ƚŽůů͕ D͕͘͘WŚ͘͘ ŚŝĞĨůŝŶŝĐĂůKĨĨŝĐĞƌ David Hochman Chairman, CEO, Founder Darren R. Sherman President, COO, Director, Founder Eric S. Fain, M.D. Board Member Eric A. Rose, M.D. Board Member Pamela Connealy Board Member Geoffrey W. Smith Board Member Jason Aryeh Board Member zƵǀĂůDŝŬĂ͕WŚ͘͘ 'DΘdK͕ ŝŽĞůĞĐƚƌŽŶŝĐdŚĞƌĂƉŝĞƐ George Papandreou, Ph.D. GM & SVP , Focal Therapies Andrew Taylor Chief Financial Officer Bill Little EVP, Corporate Dev. & Strategy
Product Platforms Target Indications Preclinical Clinical Feasibility Clinical Pivotal Partner Study Sponsor BackBeat Cardiac Neuromodulation Therapy (CNT Ρ ) Hypertension (HTN) (pacing patients; HTN+P) High - Risk HTN (non - pacing patients) ROFN CNT - HF Heart Failure Virtue® Sirolimus AngioInfusion Ρ Balloon (SAB) Coronary In - Stent Restenosis (ISR) ŽƌŽŶĂƌLJ^ŵĂůůsĞƐƐĞů;^sͿ ϭ Below - the - Knee (BTK) 1 SirolimusEFR Ρ / Microporous Balloon Urethral Strictures & BPH Osteoarthritis Advancing High - Impact Pipeline 6 FDA Breakthrough 5 FDA Breakthrough 4 FDA Breakthrough 3 1 Plan to leverage existing coronary ISR data to support potential Pivotal Study, although there have only been limited discussions with the FDA or a comparable foreign regulator in this regard. 2 Will seek to leverage data from HTN+P pilot and pivotal trials to support clinical and regulatory development for High - Risk HTN indication given that age and other demographic factors of the tar get population are expected to be similar, the type of hypertension treated will likely be isolated systolic hypertension whi ch is predominant in the HTN+P population, and other co - morbidities are also expected to be common to both target populations. However , there have been no discussions with the FDA or a comparable foreign regulator in this regard. 3 Virtue SAB has received Breakthrough Device Designation for the balloon dilatation of the stenotic portion (up to 26 mm length) of a stented coronary artery (in - stent restenosis (ISR)) that is 2.25 to 4.0 mm in diameter, for the purpose of improving lumen diameter; 4 Virtue SAB has received Breakthrough Device Designation for the balloon dilatation of the de novo stenotic portion (up to 26mm in lesion length) of a native coronary artery of 2.0 mm to 2.5 mm in diameter (sm all coronary arteries), for the purpose of improving lumen diameter; 5 Virtue SAB has received Breakthrough Device Designation for the balloon dilatation of the stenotic portion (up to 18 mm length) of an infrapopliteal artery (P - 3 segment or distal, below the knee, with reference vessel diameter (RVD) 2.25 - 4.0 mm), for the purpose of improving lumen diameter. All references to clinical study initiations for HTN+P, Coronary ISR and Coronary SV indications are based on ongoing interac tio ns with US FDA regarding IDE approvals or Japan PMDA regarding CTN approvals, which are required to start clinical studies. With respect to BackBeat CNT for HTN, Orchestra and Medtronic have h ad initial interactions with the FDA regarding IDE approval and expect to continue interactions regarding clinical trial design and submission requirements ahead of submitting documentation for approval in the second half of 2023. A pre - CTN discussion with the PMDA is planned for December 2022 with submission for CTN approval anticipated in the second half of 2023. With respect to Virtue SAB for Coronary ISR, Orchestra has been working on IDE approval with the FDA under the breakthrough designation pr ogr am to define all of the elements necessary for IDE approval and Orchestra expects to complete the agreed upon work and submit documentation for approval in Q1 of 2023. Orchestra and Terumo have had initial interactions with the PMDA and expect to submit for CTN approval for Coronary ISR and SV studies in the second half of 2023. FDA and PMDA responses are expected approximately 30 days following formal submissions; clinical study enrollment is expected to begin approximately 6 - 8 weeks after regulatory approvals; study enrollment timelines are currently estimated to be 12 - 18 months for all referenced studies although actual study enrollment timeframes may be longer; final primary endpoint results for all studies are at 12 months fr om enrollment with the exception of Japan Coronary ISR & SV studies, which are expected to be at 6 months from enrollment.
• Sponsor for BackBeat CNT HTN + Pacemaker global pivotal study • $500 - $1,600 per BackBeat CNT - enabled device sold 1 under existing reimbursement codes Medtronic • Global market leader in pacemakers: >$1.5B in annual revenues • Providing leading device plus clinical & regulatory resources • Exclusive global commercial rights for HTN+Pacemaker market • $50M equity investment in Orchestra BioMed • Right of first negotiation to expand global rights for the treatment of non - pacemaker HTN patients Strong Collaborations Position Us for Long - term Success *Total addressable market in 2025 based on company estimates; 1 Amount is based on higher of (1) a fixed dollar amount per device (amount varies materially on a country - by - county basis) or (2) a percentage of sales. 2 Based on Terumo’s consolidated financial results for the fiscal year ended March 31, 2022 7 >$10 Billion Targeted Annual Global Market Opportunities* BackBeat CNT in collaboration with Virtue SAB in collaboration with >$3 Billion Targeted Annual Global Market Opportunities * • Sponsor for Virtue ISR - US pivotal study • 10 - 15% royalty PLUS per unit payments for SirolimusEFR Ρ • Retains rights to Virtue SAB for clinical applications outside of coronary and vascular interventions Terumo • Global leader in interventional cardiology: >$2.5B in annual revenues 2 • $30M upfront payment and potential future milestones • $5M equity investment in Orchestra BioMed • Responsible for clinical and regulatory expenses, excluding Virtue ISR - US study, as well as device supply chain and commercialization • Positioned to become Terumo’s flagship therapeutic offering
8 BackBeat Cardiac Neuromodulation Therapy Ρ (CNT Ρ )
BackBeat CNT Ρ Overview 9 Unmet Need • Hypertension is the leading global risk factor for death and #1 comorbidity in pacemaker population , affecting over 70% of patients 1 • Older population at increased risk for major events & challenges with drug compliance • Additional opportunity to treat high - risk patients not indicated for a pacemaker Innovation • Bioelectronic therapy designed to substantially & persistently lower blood pressure • Compatible with standard pacemaker devices & leverages existing treatment paradigm • Compelling clinical data from double - blind randomized study : significant 8.1 mmHg net reduction in 24 - Hr aSBP at 6 months & 17.5 mmHg reduction in oSBP at 2 years 2,3 Collaboration with • Global pacemaker leader providing technology and support for global pivotal trial • Exclusive commercialization rights in the pacemaker - indicated patient population • Orchestra Biomed to receive double - digit revenue sharing 1 Company estimates based on published sources, including National Inpatient Survey (NIS) and National Health and Nutrition Exa min ation Survey (NHANES); 2 Kalaras et al. Journal of the American Heart Association. ahajournals.org/doi/10.1161/JAHA.120.020492; 3 Burkhoff. MODERATO II Study 2 - Year Results TCT 2021;. Definition s: A mbulatory Systolic Blood Pressure (aSBP) and Office Systolic Blood Pressure (oSBP)
Large Global Opportunity for Treating Hypertension in Target Populations *Total addressable market in 2025 based on company estimates; 1 Company estimates based on published sources, including National Inpatient Survey (NIS) and National Health and Nutrition Examination Survey (NHANES); 2 Known and well - characterized population, multiple references available; Definition: Hypertension (HTN) 10 >$10 Billion Potential Annual Global Market Opportunity* >3.1 M Addressable HTN Patients HTN + Pacemaker • Over 70% of pacemaker patients have HTN 1 • Older, co - morbid population at increased risk of major events 2 High Risk HTN (Non - pacemaker) • Older patients with isolated systolic hypertension (ISH) and comorbidities 750,000 patients >$2 Billion Annual Global Opportunity 2,400,000 patients >$8 Billion HTN + Pacemaker High Risk HTN
• Bioelectronic therapy designed to leverage standard dual - chamber pacemaker - Same implant procedure and lead positions - Large trained physician pool that already implant pacemakers - Same target patient population that already need pacemakers - Leverageable existing reimbursement with robust payment opportunity for novel devices with novel capabilities • Mechanism of action - Designed to substantially reduce blood pressure by reducing preload through programmed pacing with short AV delays - Designed to maintain reduction by modulating sympathetic tone and reducing afterload through programmed variable pressure patterns Designed to Substantially Lower BP & Maintain Reduction BackBeat CNT Ρ 11 Designed to Substantially and Persistently Lower Blood Pressure 1. Reducing Preload Lowers BP 2. Modulating Sympathetic Tone & Reducing Afterload Maintains Reduction in BP SBP (mmHg) Time (s) 155 150 145 140 135 130 0 50 100. 150 200 250 300
MODERATO II Double - Blind, Randomized Results ĂĐŬĞĂƚEd Ρ ƐŚŽǁĞĚĞŶĐŽƵƌĂŐŝŶŐƌĞƐƵůƚƐŝŶ DKZdK//͕ĂƉƌŽƐƉĞĐƚŝǀĞ͕ŵƵůƚŝ Ͳ ĐĞŶƚĞƌ͕ ƌĂŶĚŽŵŝnjĞĚ͕;ĂĐŬĞĂƚEdнDĞĚŝĐĂůdŚĞƌĂƉLJǀƐ͘ ŽŶƚŝŶƵĞĚDĞĚŝĐĂůdŚĞƌĂƉLJͿ͕ĚŽƵďůĞ Ͳ ďůŝŶĚ͕ƉŝůŽƚƐƚƵĚLJ ŽĨƉĂĐĞŵĂŬĞƌƉĂƚŝĞŶƚƐǁŝƚŚƉĞƌƐŝƐƚĞŶƚŚLJƉĞƌƚĞŶƐŝŽŶ 1 Kalaras et al. Journal of the American Heart Association. 2021;10:e020492 ahajournals.org/doi/10.1161/JAHA.120.020492 ; 2 Burkhoff MODERATO II Study 2 - Year Results TCT 2021; 3 24 - Hr aSBP Control (n=19),1 control patient could not be measured despite repeat measurement (patient had extremely high blood p ressure); Definitions: Major Adverse Cardiac Events (MACE) included death, heart failure, clinically significant arrhythmias (i.e., persistent or increase d a trial fibrillation, serious ventricular arrhythmias), myocardial infarction, stroke and renal failure in treatment group calculated per patient , Office Systolic Blood Pressure (oSBP), Ambulatory Systolic Blood Pressure (aSBP) 12 Significant Reduction in aSBP 24 Hours a Day - 11.1 mmHg in 24 - Hour aSBP at 6 months - 17.5 mmHg in oSBP at 2 years 0% MACE vs. 9.5% in control group at 6 months 85% of patients with reduction in aSBP 6 Months 24 Months Significant Reduction in 24 - Hr aSBP and oSBP 1,2 Ă^W oSBP 6 Months 0 - 5 - 10 - 15 - 20 - 3.1 P = 0.17 - 11.1 P < 0.001 - 12.4 P < 0.001 - 0.1 P = 0.94 Ͳ ϭϳ͘ϱ Wф Ϭ͘Ϭϭ Δ - 12.3 p = 0.02 Δ - 8.1 p = 0.01 Δ in BP (mmHg) 150 145 140 135 130 125 120 115 110 00:00 01:00 02:00 03:00 04:00 05:00 06:00 07:00 08:00 09:00 10:00 11:00 12:00 13:00 14:00 15:00 16:00 17:00 18:00 19:00 20:00 21:00 22:00 23:00 24 - Hr aSBP (mmHg) P < 0.01 for all times of day ŽŶƚƌŽů;Ŷс ϮϬ Ϳ ϯ ĂĐŬĞĂƚEd;Ŷс Ϯϲ Ϳ Pre - activation (n=26) 6 months (n=26) 6 Month Mean Pre - activation Mean
BackBeat CNT Ρ Pivotal Trial Design 13 Current anticipated trial design: • Prospective, multi - center, double - blind study investigating the efficacy of BackBeat CNT Ρ in patients with uncontrolled hypertension (HTN) despite the use of antihypertensive medications, who are indicated for a dual - chamber pacemaker • Inclusion and exclusion criteria for enrollment in the BackBeat CNT Pivotal Study will be similar to the criteria used in the MODERATO II study • Patients will be randomized 1:1 in a double - blinded manner to either active treatment with BackBeat CNT with continued antihypertensive medications or standard pacing only with continued antihypertensive medications • Anticipated primary efficacy and safety endpoints: - Efficacy endpoint: Superiority of treatment as compared to control based on mean change in 24 - hour aSBP at 3 months post randomization - Safety endpoint: Safety assessment will include evaluation of differences in composite cardiovascular adverse events (CCAE) between groups at 12 months • Enroll patients across ~80 study sites planned for United States, Europe and, potentially, Japan
14 sŝƌƚƵĞΠ^ŝƌŽůŝŵƵƐ ŶŐŝŽ/ŶĨƵƐŝŽŶ Ρ ĂůůŽŽŶ;^Ϳ
Virtue® SAB Overview 15 Unmet Need • Artery disease is the leading cause of death in the U.S. and worldwide • Significant paradigm shift toward “leave nothing behind” treatment for coronary and peripheral indications representing an > $3B global market opportunity 1 • Current treatment options are suboptimal and are associated with long - term risks and complications Innovation • Highly - differentiated, non - coated drug/device combination product candidate designed to reduce long - term complications by enabling angioplasty with protected delivery of extended release sirolimus • Compelling clinical results in multi - center coronary ISR clinical trial with 3 - year follow - up 2 • FDA Breakthrough Device Designation received for indications in coronary ISR 3 , coronary SV 4 and BTK 5 Partnership with • Global commercial leader with >$2.5B annual interventional cardiology revenue responsible for commercializing Virtue SAB as flagship therapeutic offering • Collaboration driving multi - indication pivotal trial program starting with coronary ISR • Orchestra BioMed to receive double - digit royalties and per unit drug payments 1 Total addressable market is 2025 market data based on company estimates; ; 2 von Birgelen et al. JACC Vol. 59, No. 15, 2012 April 10, 2012:1350 – 61; Virtue SAB has received Breakthrough Device Designation for: 3 The balloon dilatation of the stenotic portion (up to 26 mm length) of a stented coronary artery (in - stent restenosis (ISR)) tha t is 2.25 to 4.0 mm in diameter, for the purpose of improving lumen diameter; 4 The balloon dilation of the de novo stenotic portion (up to 26mm in lesion length) of a native coronary artery of 2.0 mm to 2.5 mm in diameter (small coronary arteries), for the purpose of improving lumen diameter; 5 The balloon dilatation of the stenotic portion (up to 18 mm length) of an infrapopliteal artery (P - 3 segment or distal, below the knee, with reference vessel diameter (RVD) 2.25 - 4.0 mm), for the p urpose of improving lumen diameter.
Large Opportunity for Leave Nothing Behind Solution 16 >$3 Billion Annual Global CAD & PAD Market Opportunity * ‡ ƌƚĞƌLJĚŝƐĞĂƐĞŝƐƚŚĞƉƌŝŵĂƌLJ ĐĂƵƐĞŽĨĚĞĂƚŚǁŽƌůĚǁŝĚĞ ‡ >ĂƌŐĞŵĂƚƵƌĞŵĂƌŬĞƚǁŝƚŚ ƐŝŐŶŝĨŝĐĂŶƚƵŶŵĞƚŶĞĞĚ Ă ^ƵďŽƉƚŝŵĂůƚƌĞĂƚŵĞŶƚƐĨŽƌ ĐŽƌŽŶĂƌLJ/^Z͕ĐŽƌŽŶĂƌLJ^s ĚĞ ŶŽǀŽ ĂŶĚd< ‡ ĞƐŝŐŶĞĚƚŽůĞǀĞƌĂŐĞĞdžŝƐƚŝŶŐ ƚƌĞĂƚŵĞŶƚƉĂƌĂĚŝŐŵΘ ĞƐƚĂďůŝƐŚĞĚƚĞĐŚŶŽůŽŐŝĞƐ͗ ƐŝƌŽůŝŵƵƐĂŶĚďĂůůŽŽŶ ĂŶŐŝŽƉůĂƐƚLJ >3.2M Addressable CAD & PAD Patients (2025 Estimate) ~2,000,000 patients > $1.8 Billion Annual Global Opportunity ~1,250,000 patients > $1.2 Billion Coronary Peripheral *Total addressable market in 2025 based on company estimates; Definitions: Coronary Artery Disease (CAD), Peripheral A rtery D isease (PAD), In - stent Restenosis (ISR), Small Vessel (SV, ≤2.5mm), High bleeding Risk De Novo (>2.5mm), Below - t he - Knee (BTK , Rutherford 3 - 6, w/out severe comorbidities).
sŝƌƚƵĞΠ^ ŶŐŝŽ/ŶĨƵƐŝŽŶ Ρ ĂůůŽŽŶ ĚĞƐŝŐŶĞĚƚŽĞŶĂďůĞĂŶŐŝŽƉůĂƐƚLJ ǁŝƚŚƉƌŽƚĞĐƚĞĚĚƌƵŐĚĞůŝǀĞƌLJƚŽĚŝůĂƚĞǀĞƐƐĞů͕ƚŽĐŽŶƐŝƐƚĞŶƚůLJ ĚĞůŝǀĞƌŝŶƚĞŶĚĞĚĚŽƐĞĂŶĚƚŽůĞĂǀĞŶŽŵĞƚĂůďĞŚŝŶĚ Designed to Enable Angioplasty with Protected Sirolimus Delivery while Leaving No Metal Behind 17 1 Granada et al. EuroIntervention 2016;12:740 - 747 Precise dose protected in dose unit Inflated to deliver dose through micropores ^ŝƌŽůŝŵƵƐ&Z Ρ &ŽƌŵƵůĂƚŝŽŶ ƉƌŽǀŝĚĞĚĞdžƚĞŶĚĞĚĨŽĐĂů ƌĞůĞĂƐĞŽĨƚŚĞƌĂƉĞƵƚŝĐůĞǀĞůƐŽĨƐŝƌŽůŝŵƵƐƚŚƌŽƵŐŚĐƌŝƚŝĐĂů ŚĞĂůŝŶŐƉĞƌŝŽĚ; у ϯϬ ĚĂLJƐͿ ϭ ϭϬϬϬ 100 10 1 0.1 0.01 0.001 Ϭ͘ϬϬϬϭ ^ŝƌŽůŝŵƵƐdŝƐƐƵĞŽŶĐĞŶƚƌĂƚŝŽŶ;ŶŐͬŵŐͿ Required Therapeutic Concentration > 1ng/mg Lung, liver & kidney below level of assay quantification (0.1 ng/mg) in <1 week 0 5 10 15 ϮϬ Ϯϱ 30 Coronary Distal Kidney Liver Lun g Time (Days) N = 753 porcine coronary artery segments Protected Delivery/No Drug Coating • No drug loss in transit • No time limits on delivery • No drug coating particulates
Compelling SABRE Trial Results in Coronary ISR Patients ϭ sĞƌŚĞLJĞĞƚĂů͘:ĂƌĚŝŽǀĂƐĐ/ŶƚĞƌǀ ϮϬϭϳ KĐƚ Ϯϯ ͖ ϭϬ ; ϮϬ Ϳ͗ ϮϬϮϵ Ͳ ϮϬϯϳ ͘K/͗ ϭϬ͘ϭϬϭϲ ͬũ͘ũĐŝŶ͘ ϮϬϭϳ͘Ϭϲ͘ϬϮϭ ͘ Ϯ 'ƌĂŶĂĚĂ ϯ Ͳ zĞĂƌůŝŶŝĐĂůZĞƐƵůƚƐdd ϮϬϭϴ ͘ ϯ Ͳ zĞĂƌ^ZdƌŝĂůůŝŶŝĐĂůZĞƉŽƌƚŽŶĨŝůĞ͘ ĞĨŝŶŝƚŝŽŶƐ͗ dĂƌŐĞƚůĞƐŝŽŶĨĂŝůƵƌĞ;d>&Ϳ͕ůĂƚĞůƵŵĞŶůŽƐƐ;>>>Ϳ͕ƚĂƌŐĞƚůĞƐŝŽŶƌĞǀĂƐĐƵůĂƌŝnjĂƚŝŽŶ;d>ZͿĂŶĚDLJŽĐĂƌĚŝĂů/ŶĨĂƌĐƚŝŽŶ;D/Ϳ͘ ϭϴ Virtue® SAB preliminarily demonstrated encouraging safety and efficacy results in patients with coronary in - stent restenosis (ISR) in prospective, multi - center SABRE Trial 1 0.12 mm LLL at 6 - months 2.8% Target Lesion Failure at 1 year 0% New TLR between 1 to 3 years Demonstrated Preliminary Safety Data with Low Safety Event Rates Out to 3 Years 2 Preliminary Efficacy Results Showed Low 0.12mm Late Loss 1 RVD reported using Internormal values; 2 Trial primary performance endpoint; 3 Trial secondary performance endpoint (binary restenosis = >50% lumen diameter stenosis). 4 Data is based on per protocol population criteria revised to be consistent with proposed Virtue ISR - US pivotal study population. Event Rates (%) ĂƌĚŝĂĐĞĂƚŚ TV - MI TLR TLF 10% 9% 8% ϳ й ϲ й 5% 4% 3% 2% 1% 0% Ϭ й ϯϬ ĚĂLJƐ ϭ Ͳ LJĞĂƌ ϯ Ͳ LJĞĂƌƐ 0% 0% 0% 0% 0% 0% Ϯ͘ϴ й Ϯ͘ϴ й 2.8% 2.8% 5.6% 4
Virtue® SAB Coronary ISR US Pivotal Trial 19 ŽƵďůĞ Ͳ ďůŝŶĚ͕ŵƵůƚŝ Ͳ ĐĞŶƚĞƌ͕ƉƌŽƐƉĞĐƚŝǀĞ͕ ƌĂŶĚŽŵŝnjĞĚ ĐŽŶƚƌŽůůĞĚƐƚƵĚLJ ŝŶƉĂƚŝĞŶƚƐǁŝƚŚ ƐŝŶŐůĞ Ͳ ůĂLJĞƌĐŽƌŽŶĂƌLJ /^Z sŝƌƚƵĞΠ^ Eс ϮϬϬ R Target Lesion Failure (CD, TV - MI and TLR) at 12 months Primary Endpoint Statistical Assumption 90% powered for superiority Virtue SAB TLF ≤ 19% vs. PBA TLF ≥ 30% Success Considerations Virtue SAB: 2.8% TLF at 12 months in SABRE trial per protocol population PBA: 33 - 46% TLF at 12 months in coronary ISR published studies 12 Month Primary Endpoint 12 - 18 Months Enrollment <ĞLJ/ŶĐůƵƐŝŽŶ Zs Ϯ͘ϱ ƚŽ ϰ͘Ϭ ŵŵ͕ ф ϯϬ й^ ;ǀƐ͘Zs Ϯ͘ϱ ƚŽ ϯ͘ϱ ͕ ф ϰϬ й^^Z ϭ dƌŝĂů Ϳ W Eс ϭϬϬ Prospective, single - arm, controlled study in patients with double - layer coronary ISR Virtue® SAB N=100 Key Inclusion RVD 2.5 to 4.0 mm, <30% DS (vs. RVD 2.5 to 3.5, <40% DS SABRE 1 Trial ) Target Lesion Failure (CD, TV - MI and TLR) at 12 months 1 Verheye S. JACC Cardiovasc Interv . 2017; 10: 2029 - 37. Definitions: Coronary In - stent Restenosis (ISR), Diameter Stenosis (DS), Plain Balloon Angioplasty (PBA). Revised per protocol analysis set meets the criteria of the proposed In - Stent Restenosis IDE study population . Randomized Study Arm to Support Regulatory Approval: Single - Layer Coronary ISR EŽŶ Ͳ ZĂŶĚŽŵŝnjĞĚ^ƚƵĚLJƌŵ͗ŽƵďůĞ Ͳ >ĂLJĞƌŽƌŽŶĂƌLJ/^Z WƌŝŵĂƌLJŶĚƉŽŝŶƚ Study Objective Provide additional clinical data in support of use in double - layer Coronary ISR without confounding TLF performance results in single - layer Coronary ISR
2023 - Anticipated Milestones Planned Regulatory Milestones Planned Clinical Milestones 20 1 Timing estimated and subject to Terumo execution since Terumo controls development of Virtue SAB for SV indication and for IS R i n Japan ‡ ĂĐŬĞĂƚEd ,dEнW ϭ Ɛƚ Wƚ͘ŶƌŽůůŵĞŶƚ ‡ sŝƌƚƵĞ^ ŽƌŽŶĂƌLJ/^Z ϭ ƐƚWƚ͘ŶƌŽůůŵĞŶƚ ‡ Ed Ͳ ,&ĂŶĚ^ŝƌŽůŝŵƵƐ&ZWƌŽŐƌĂŵ hƉĚĂƚĞƐ ‡ ĂĐŬĞĂƚEd ,dEнWĂĐĞŵĂŬĞƌ&/ƉƉƌŽǀĂů ‡ sŝƌƚƵĞ^ŽƌŽŶĂƌLJ/^Z sŝƌƚƵĞ Ͳ /^Z Ͳ h^&/ƉƉƌŽǀĂů :ĂƉĂŶWDdEƉƉƌŽǀĂů ϭ ‡ sŝƌƚƵĞ^ ʹ ŽƌŽŶĂƌLJ^s :ĂƉĂŶWDdEƉƉƌŽǀĂů ϭ
21 Two Programs Targeting Large Markets Supported by Promising Trial Data Entering Pivotal Trials – BackBeat CNT Ρ • >$10 billion annual market • R andomized, controlled study shows efficacy potential • Collaboration with – V irtue® SAB • ∼ $3 billion annual market • 3 - year pilot study results show potential safety & efficacy • Partnered with Strong Balance Sheet and Committed Strategic and Financial Investors ƌŝŶŐŝŶŐ DĞĚŝĐĂů /ŶŶǀĂƚŝŽŶƐ ƚŽ>ŝĨĞdŚƌŽƵŐŚ WĂƌƚŶĞƌƐŚŝƉƐ WĂƌƚŶĞƌƐŚŝƉ Ͳ ŶĂďůĞĚ ƵƐŝŶĞƐƐDŽĚĞů Θ ĐĐŽŵƉůŝƐŚĞĚ>ĞĂĚĞƌƐŚŝƉ dĞĂŵ ʹ ĞƐŝŐŶĞĚƚŽĂĐĐĞůĞƌĂƚĞ ŝŶŶŽǀĂƚŝŽŶƚŽƉĂƚŝĞŶƚƐ͕ ĞŶĂďůĞƉŝƉĞůŝŶĞĞdžƉĂŶƐŝŽŶ ĂŶĚĚƌŝǀĞƐƚƌŽŶŐƉĂƌƚŶĞƌĂŶĚ ƐŚĂƌĞŚŽůĚĞƌǀĂůƵĞ ʹ ,ŝŐŚůLJĞdžƉĞƌŝĞŶĐĞĚƚĞĂŵǁŝƚŚ Ɖ ƌŽǀĞŶƚƌĂĐŬƌĞĐŽƌĚŽĨ ŝŶŶŽǀĂƚŝŽŶĂŶĚĞdžĞĐƵƚŝŽŶ
Partnership - Enabled Business Model 22
Significant Barriers Prevent Innovation From Reaching Patients 23 Startups often struggle for resources to reach commercial value inflection Large companies’ constrained R&D budgets limit innovation & acquisitions /ŶĐƌĞĂƐŝŶŐďƵƌĚĞŶŽĨĐŽƐƚ͕ƚŝŵĞ͕ĂŶĚǁŽƌŬ ƚŽďƌŝŶŐŵĞĚŝĐĂůŝŶŶŽǀĂƚŝŽŶƚŽƉĂƚŝĞŶƚƐ WƌŽĚƵĐƚĞǀĞůŽƉŵĞŶƚ Commercialization 1 Pitchbook – Analysis of 430 companies since 2015 that completed at least Series B financing 2 SVB Healthcare Report 2019 3 Capital IQ Avg $60M funding needed, 85% of acquisitions required commercial traction 1 Avg 7% of revenue spent on R&D by top 20 med device vs. 20% in pharma 2,3
Orchestra BioMed Can Accelerate Innovation to Patients 24 ZŝƐŬ Ͳ ZĞǁĂƌĚ^ŚĂƌŝŶŐ WĂƌƚŶĞƌƐŚŝƉƐ ĂŶKǀĞƌĐŽŵĞƚŚĞĂƌƌŝĞƌƐƚŽ/ŶŶŽǀĂƚŝŽŶ
Ϯϱ Large Market with Unmet Needs Potential for High Impact Favorable for Partnering Key Pipeline Criteria Large market, significant unmet needs, established distribution channels Designed to improve standard of care, fit existing treatment paradigm, disrupt market dynamics ^ŝŐŶŝĨŝĐĂŶƚĚŝĨĨĞƌĞŶƚŝĂƚŝŽŶ͕ĂƚƚƌĂĐƚŝǀĞĞĐŽŶŽŵŝĐƐĨŽƌƉĂƌƚŶĞƌƐŚŝƉ͕ĚƵƌĂďůĞ/W ƉƌŽƚĞĐƚŝŽŶ ^ĞůĞĐƚŝŶŐKƉƚŝŵĂůKƉƉŽƌƚƵŶŝƚŝĞƐ Develop for Partnership Pre - partnered Acquisitions Innovation Royalty - based R&D Programs
Orchestrating Inn vation 26 ƌĞĂƚĞĚWŝƉĞůŝŶĞ͕WŝŽŶĞĞƌĞĚƵƐŝŶĞƐƐDŽĚĞůĂŶĚƐƚĂďůŝƐŚĞĚWĂƌƚŶĞƌƐŚŝƉƐ ŽŵďŝŶĞĚ͕ŽƵƌůĞĂĚĞƌƐŚŝƉƚĞĂŵŚĂƐ Years of experience Average years of experience each New product approvals/clearances Authored patents 250 + 25 ϭϬϬ н ϲϬϬ н Accomplished Leadership Team