UNITED STATES
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Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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| 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.
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 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: November 14, 2023 | ||
| 3 |
Exhibit 99.1
Orchestra BioMed Corporate Presentation Q4 2023
| Corporate Presentation Q4 2023 2 This presentation has been prepared for informational purposes only from information supplied by Orchestra BioMed Holdings, Inc . , 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 completeness of such information . 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 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 potential safety and efficacy of our product candidates, the initiation and timing of our planned pivotal trials and reporting of top - line results, expected market sizes for our product candidates, the ability of our partnerships to accelerate clinical development, and our estimated future financial performance and financial position . These statements are based on various assumptions, whether or not identified in this document, 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 product candidates ; 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 1 A . 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 1 A . 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 risks and uncertainties, the Company cautions against placing undue reliance on these forward - looking statements, which only speak as of the date of this presentation . The Company does not plan and undertakes no obligation to update any of the forward - looking statements made herein, except as required by law . Forward - Looking Statements
3 Expected c ash runway into 2H 2026 Major strategic & institutional investors • Statistically significant double - blind, randomized pilot study trial efficacy data • IDE approved • Global pivotal study starting Q4 2023 >ĞĂĚWƌŽŐƌĂŵ ĂĐŬĞĂƚEd Ρ ;s/DΎƚŚĞƌĂƉLJͿ dĂƌŐĞƚƐхΨ ϭϬ ĂŶŶƵĂů ŚLJƉĞƌƚĞŶƐŝŽŶŵĂƌŬĞƚƐ Strategic collaboration Orchestra BioMed Executive Overview | Corporate Presentation Q4 2023 Pipeline Program Virtue® SAB • Targets >$3B annual artery disease markets • Strong 3 - year multi - center pilot study safety and efficacy data • Conditional IDE approved ; study expected in 2024 Partnership - enabled business model designed to: Accelerate innovation to patients ƌŝǀĞƐƚƌŽŶŐƉĂƌƚŶĞƌĂŶĚƐŚĂƌĞŚŽůĚĞƌǀĂůƵĞ Yield exceptional future profitability Strategic collaboration Double - digit revenue share Double - digit revenue share *AVIM = atrioventricular interval modulation
Orchestra BioMed Development ŽŵŵĞƌĐŝĂůŝnjĂƚŝŽŶ Strategic Partners Shared Benefits Innovation Secure substantial long - term royalties Outsource commercialization Multiple pipeline opportunities Improve patient lives Accelerate development Leverage expertise & resources Enable new growth opportunities Outsource development Minimize P&L dilution Orchestra BioMed’s Partnership - Enabled Model Benefits All 4 ͮ ŽƌƉŽƌĂƚĞWƌĞƐĞŶƚĂƚŝŽŶY ϰϮϬϮϯ
1 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 target population are expected to be similar, the type of hype rte nsion treated will likely be isolated systolic hypertension which 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 o r a comparable foreign regulator in this regard. 2 Plan to leverage existing coronary ISR data to support potential Pivotal Study, although there have only been limited discuss ion s with the FDA or a comparable foreign regulator in this regard. 3Virtue SAB has received Breakthrough Device Designation for the balloon dilatation of the stenotic portion (up to 26 mm leng th) 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; 4Virtue 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 (small coronary ar ter ies), for the purpose of improving lumen diameter; Product Platforms Target Indications Preclinical Clinical Feasibility Clinical Pivotal Partner Study Sponsor Lead Program BackBeat CNT Ρ (AVIM Therapy) Hypertension (HTN) (pacing patients; HTN+P) High - Risk HTN 2 (non - pacing patients) ROFN CNT - HF Heart Failure WŝƉĞůŝŶĞWƌŽŐƌĂŵ Virtue® Sirolimus AngioInfusion Ρ Balloon (SAB) Coronary In - Stent Restenosis (ISR) – U.S. Coronary Small Vessel (SV) 1 - U.S. Coronary SV/ISR - Japan IDE Approved & FDA Breakthrough 3 FDA Breakthrough 4 IDE Approved 5 Advancing High - Impact Pipeline | Corporate Presentation Q4 2023
Executive Team: | >300 Years of Experience | ~25 Avg Industry Years | >100 Product Approvals | >600 Authored Patents David Hochman Chairman, CEO, Founder Darren R. Sherman President, COO, Director, Founder Andrew Taylor Chief Financial Officer Yuval Mika, Ph.D. GM & CTO, Bioelectronic Therapies George Papandreou, Ph.D. GM & SVP , Focal Therapies Hans - Peter Stoll, M.D., Ph.D. Chief Clinical Officer Bill Little EVP, Corporate Development & Strategy Avi Fischer, M.D. SVP, Medical Affairs & Innovation Bob Laughner SVP, Regulatory & Quality Ziv Belsky VP, Research, Bioelectronic Therapies Juan Lorenzo SVP, Product Development, Focal Therapies Lisa Daniels VP, Human Resources Highly Accomplished Executive Team & Board Independent Board Members Jason Aryeh Pamela Connealy Eric S. Fain, M.D. Eric A. Rose, M.D. 6 | Corporate Presentation Q4 2023
BackBeat CNT Ρ Atrioventricular interval modulation (AVIM) therapy 7 | Corporate Presentation Q4 2023
AVIM Therapy Overview 1 Company estimates based on published sources, including National Inpatient Survey (NIS) and National Health and Nutrition Exa min ation Survey (NHANES) Collaboration with 8 Hypertension is the leading global risk factor for death and #1 comorbidity in the pacemaker population (over 70%) 1 Unmet Need Pacemaker - delivered therapy designed to immediately, persistently and substantially lower blood pressure Over 750K patients annually receiving pacemakers also have hypertension Opportunity Innovation | Corporate Presentation Q4 2023
9 *Total addressable market in 2025 based on company estimates; 1Company estimates based on published sources, including Nation al Inpatient Survey (NIS) and National Health and Nutrition Examination Survey (NHANES); Definition: Hypertension (HTN) Annual Global Opportunity Large Global Opportunity for Treating Hypertension in Target Populations | Corporate Presentation Q4 2023 HTN + Pacemaker ~70% of pacemaker patients 1 750,000 patients >$2 Billion* High Risk HTN ~0.2% of HTN patients 2,400,000 patients >$8 Billion* o Same pacemaker patients, same device implant, and same treating physicians o Leverageable existing reimbursement structures o Older patients with uncontrolled hypertension and other significant comorbidities o Similar demographic to pacemaker patients, high - risk, difficult - to - treat
o Developed BackBeat CNT (AVIM therapy) from concept stage; owns all related IP o Conducted all prior development work including MODERATO I & II clinical studies o Partnered with Medtronic for global regulatory approval and commercialization o Sponsor for the BACKBEAT Study o $500 - $1,600 revenue share per AVIM - enabled device 1 10 o Global market leader in cardiac pacing therapy: >$1.5B in annual revenues o Providing leading device plus clinical & regulatory resources o Exclusive global commercial rights for AVIM therapy in pacemaker - indicated patients o Right of first negotiation to expand global rights for the treatment of non - pacemaker HTN patients o $50M equity investment in Orchestra BioMed 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. Strategic Collaboration | Corporate Presentation Q4 2023
Short AV pacing Pressure overshoot indicating increased Total Peripheral Resistance (TPR) ANS response drives blood pressure back toward baseline Bioelectronic Control of Ventricular Filling Immediately Reduces Blood Pressure 11 AVIM - Mediated Pressure Patterns Modulate Autonomic Nervous System (ANS) Response AV (Atrioventricular), TPR (Total Peripheral Resistance) AVIM ACTIVATION Slow increase in blood pressure suggesting modulation of ANS activity and TPR AVIM pacing 60 Sec 60 Sec Time Pressure Time Pressure Novel Mechanism of Action Designed to Substantially Reduce Blood Pressure | Corporate Presentation Q4 2023 Stable blood pressure reduction
12 Feasibility Study in Canine HTN Model Proof of concept in 5 dogs Acute Feasibility Study in Subjects with HTN 18 patients 2012 ϮϬϭϲ MODERATO II – Pilot Study Prospective, multi - center, randomized, controlled, double - blind pilot study in 47 patients – 6 - month primary endpoint data late - breaking presentation at TCT ϮϬϭϵ MODERATO I - First In - Human Implant Study Multi - center, Single - arm Study in 27 patients TCT Innovation Shark Tank Award Best Abstract at ICI MODERATO II Two - year and ISH results Presented at TCT Peer - Reviewed Publication of MODERATO II Results in the Journal of the American Heart Association Existing Body of Clinical Data Supporting Efficacy and Safety | Corporate Presentation Q 4 2023
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 pressure) ; D efinitions: Major Adverse Cardiac Events (MACE) included death, heart failure, clinically significant arrhythmias (i.e., persistent or increased atrial fibrillation, serious ventricular arr hyt hmias), myocardial infarction, stroke and renal failure in treatment group calculated per patient, Office Systolic Blood Pressure (oSBP); Ambulatory Systolic Blood Pressure (aSBP) Significant Reduction in 24 - Hr aSBP and oSBP 1,2 Control (n=20) 3 AVIM Therapy (n=26) - 11.1 mmHg - 17.5 mmHg 0 % 85% 13 6 Months 24 Months aSBP oSBP 6 Months 0 - 5 - 10 - 15 - 20 - 11.1 P < 0.001 - 12.4 P < 0.001 - 0.1 P = 0.94 - 17.5 P < 0.01 Δ - 12.3 p = 0.02 Δ - 8.1 p = 0.01 Δ in BP (mmHg) - 3.1 P = 0.17 - 15. 6 P < 0.001 - 1.5 P = 0.5 1 day Δ - 14.1 p = 0.001 ĂĐŬĞĂƚEd Ρ ;s/DƚŚĞƌĂƉLJͿ ƐŚŽǁĞĚĞŶĐŽƵƌĂŐŝŶŐƌĞƐƵůƚƐŝŶ DKZdK//͕ĂƉƌŽƐƉĞĐƚŝǀĞ͕ ŵƵůƚŝ Ͳ ĐĞŶƚĞƌ͕ƌĂŶĚŽŵŝnjĞĚ͕ ;ĂĐŬĞĂƚEdнŵĞĚŝĐĂů ƚŚĞƌĂƉLJǀƐ͘ĐŽŶƚŝŶƵĞĚŵĞĚŝĐĂů ƚŚĞƌĂƉLJͿ͕ĐŽŶƚƌŽůůĞĚ͕ĚŽƵďůĞ Ͳ ďůŝŶĚ͕ƉŝůŽƚƐƚƵĚLJŽĨƉĂĐĞŵĂŬĞƌ ƉĂƚŝĞŶƚƐǁŝƚŚƉĞƌƐŝƐƚĞŶƚ ŚLJƉĞƌƚĞŶƐŝŽŶ MODERATO II Randomized, Double - Blind Results | Corporate Presentation Q4 2023
FDA IDE - approved Efficacy endpoint: Safety endpoint: at 3 months post randomization Secondary/additional endpoints 500 patients across ~80 study sites 14 <d^ƚƵĚLJ^ƵŵŵĂƌLJ | Corporate Presentation Q4 2023
NO DEVICE IMPLANTS IN STUDY Hypertensive patients with a recent Medtronic pacemaker implant 15 Test eligibility at end of Run - in R Treatment: AVIM therapy + medical therapy WƌŝŵĂƌLJ Ăƚ ϯ D Control: Medical therapy Follow - up at 12M AVIM therapy download and set up Run - In Phase Standard Pacing only Withdraw No Informed Consent Pre - Screening 90 days Run - in Phase 4 - weeks Enrollment/ Randomization Blinded Study 12 months Open - Label Crossover Follow - up Phase WƌŝŵĂƌLJ Ăƚ ϯ D Follow - up at 12M BACKBEAT Study Design | Corporate Presentation Q 4 2023 Potential Regulatory Submissions 2 years from unblinding Target completion of enrollment in mid - 2025
Virtue® Sirolimus AngioInfusion Ρ Balloon (SAB) ϭϲ | Corporate Presentation Q4 2023
17 o Significant opportunity in an established multi - billion dollar market migrating toward drug - eluting balloons as the new standard of care o Highly - differentiated, best - in - class non - coated drug/device combination designed to overcome limitations of drug - coated balloons o Strategic collaboration with Terumo , a g lobal leader in interventional cardiology devices with >$ 2.5 B in annual division revenues C ollaboration w ith Designed to Enable Angioplasty with Protected Delivery of Extended - Release Sirolimus with Nothing Left Behind Virtue ® SAB overview | Corporate Presentation Q4 2023
ŶŐŝŽƉůĂƐƚLJǁŝƚŚ WƌŽƚĞĐƚĞĚĞůŝǀĞƌLJ ŽĨdžƚĞŶĚĞĚZĞůĞĂƐĞ ^ŝƌŽůŝŵƵƐ Virtue ® SAB – Redefining the Class of Drug - Eluting Balloons 1000 100 10 1 0.1 0.01 Ϭ͘ϬϬϭ 0.0001 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 25 30 Target Lesion Distal tissue Kidney Liver Lun g Time (Days) N = 753 porcine coronary artery segments Sirolimus Tissue Concentration (ng/mg) 1 Granada et al. EuroIntervention 2016;12:740 - 747 ͮ ŽƌƉŽƌĂƚĞWƌĞƐĞŶƚĂƚŝŽŶY ϰϮϬϮϯ 18 Published Animal Data Demonstrates Therapeutic Sirolimus Tissue Concentration Through Critical Healing Period DŝĐƌŽƉŽƌŽƵƐ ŶŐŝŽ/ŶĨƵƐŝŽŶ Ρ ĂůůŽŽŶ ^ŝƌŽůŝŵƵƐ&Z Ρ Precise dose loaded inside balloon system No c oating = no drug loss in transit Intended dose delivered during angioplasty No c oating = no large particulate 1 Ϯ 3 Standard navigation to lesion No c oating
sŝƌƚƵĞ^ ;^ŝƌŽůŝŵƵƐ&ZͿ Paclitaxel - coated balloons Sirolimus - coated balloons Superior Pharmaceutical Agent for Restenosis Based on 26 DES coronary RCTs ض X ض Peer - Reviewed Pharmacokinetics Data for >28 days elution ض - X No Coating No rush to target lesion, no large particulate ض X X Protected Drug Delivery No drug loss in transit; deliver full/intended dose at time of angioplasty ض X X No Procedural Time Constraints No limitations in time to deliver balloon to lesion ض X X Does Not Generate Large Particulates Non - coated drug - eluting balloon ض X X Virtue SAB: Highly Differentiated 19 DES = drug - eluting stents; RCT = randomized control trial | Corporate Presentation Q4 2023
Compelling SABRE Trial Results in Coronary ISR Patients 1 Verheye et al. JACC Cardiovasc Interv 2017 Oct 23;10(20):2029 - 2037. DOI: 10.1016/j.jcin.2017.06.021. 2 Granada 3 - Year Clinical Results TCT 2018. 3 - Year SABRE Trial Clinical Report on file. Definitions: Target lesion failure (TLF), late lumen loss (LLL), target lesion revascularization (TLR) and Myocardial Infarction (MI). Demonstrated Preliminary Safety Data with Low Safety Event Rates Out to 3 Years 2 Preliminary Efficacy Results Showed Low 0.12mm Late Loss Virtue® SAB preliminarily demonstrated encouraging safety and efficacy results in patients with coronary in - stent restenosis (ISR) in prospective, multi - center SABRE Trial 1 0.12mm LLL at 6 - months 2.8% Target Lesion Failure at 1 year 0% New TLR between 1 to 3 years 5.6% 2.8% 2.8% 2.8% 0 % 0% 0% 0% 0% 0% 0% 2.8% Cardiac Death TV - MI TLR TLF Event Rates (%) 30 days 1 - year 3 - years WĞƌWƌŽƚŽĐŽů ϰ n 36 Reference Vessel Dianeter (RVD) mm 1 2.52 ц 0.32 Minimum Lumen Diameter (MLD) mm 1.96 ц 0.32 % Diameter Stenosis 22.3 ц 9.4 Change in % Diameter Stenosis 5.2 ц 11.4 Late Lumen Loss (LLL) mm 2 0.12 ц 0.33 Binary Restenosis 3 2.8% 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. | Corporate Presentation Q 4 2023 20
21 Lead program, BackBeat CNT (AVIM therapy) positioned to enter global pivotal trial by end of 2023 with strong strategic partner ▪ 70% of pacemaker patients also have hypertension, equating to an addressable annual market opportunity of approximately 750,000 patients worldwide valued at over $2 billion ▪ Medtronic is the ideal partner as the global leader in cardiac pacing therapies ▪ Orchestra BioMed has a substantial royalty - based revenue sharing interest in future commercial sales and is expected to receive between $500 - 1600 for each AVIM - enabled pacemaker sold ▪ Significant follow - on market opportunity in other targeted high - risk populations Pipeline program, Virtue SAB represents a highly differentiated solution for a significant established market , with strong strategic partner and an approved IDE for pivotal study in lead coronary indication Novel business model provides pathway for pipeline expansion and additional strategic collaborations Expected cash runway into 2H 2026 , beyond target reporting of top - line data readout for BACKBEAT study Key Takeaways and Strategic Priorities | Corporate Presentation Q4 2023
Bringing Medical Innovations to Life Through Partnerships 22 | Corporate Presentation Q 4 2023