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
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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).
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| Item 7.01. | Regulation FD Disclosure. |
On October 10, 2023, Orchestra BioMed Holdings, Inc. (the “Company,” “we,” or “our”) filed a registration statement on Form S-1 (the “Registration Statement”) to register under the Securities Act of 1933, as amended, the resale of certain shares of its common stock, par value $0.0001 per share (“Common Stock”), the resale of certain warrants to purchase Common Stock and the issuance of certain shares of Common Stock underlying warrants, as required by the terms of the Amended and Restated Registration Rights and Lock-Up Agreement it entered into on January 26, 2023 with certain investors. The Company did not file the Registration Statement as part of an effort to raise capital and is not seeking to raise additional capital at this time.
The Registration Statement includes, among other things, the following updated information:
As previously disclosed, the Company, on the one hand, and Terumo Corporation and its U.S. subsidiary, Terumo Medical Corporation (collectively, “Terumo”), on the other hand, have been negotiating mutually agreeable adjustments to the Company’s distribution agreement with Terumo (the “Terumo Agreement”) that could serve to restructure milestone payments as well as make other potential material modifications to the Terumo Agreement. Until we gain clarity on the likely outcome of such ongoing negotiations, our current expectation is that the initiation of the Virtue ISR-US pivotal study evaluating the efficacy and safety of our Virtue Sirolimus AngioInfusion Balloon (“Virtue SAB”) will be postponed until 2024. If negotiations are not completed to our satisfaction or to the satisfaction of Terumo, clinical study, product development, and commercialization plans for Virtue SAB may continue to be adversely impacted.
An updated copy of the slide presentation that the Company uses at investor and industry conferences and presentations is attached to this Current Report on Form 8-K (this “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.
Forward-Looking Statements
Certain statements included in this Current Report 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 timing of the Virtue ISR-US pivotal study. These statements are based on various assumptions, whether or not identified in this Current Report, 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; failure to realize the anticipated benefits of the business combination; 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 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 risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this Current Report. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law.
| 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). |
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: October 10, 2023 | ||
Exhibit 99.1
Orchestra BioMed Corporate Presentation Q4 2023
| Corporate Presentation Q4 2023 2 Forward - Looking Statements 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 timing of our planned pivotal trials, 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 ; failure to realize the anticipated benefits of the business combination ; 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 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 .
Orchestra BioMed Executive Summary Strong balance sheet and outstanding investors: Strong 3 - year multi - center preliminary trial safety and efficacy data Plan to initiate pivotal study in 2024 Strategic collaboration Double - digit revenue share Virtue® SAB targets >$3B annual artery disease markets Protected sirolimus delivery, non - coated balloon Partnership - enabled business model designed to: Accelerate innovation to patients Drive strong partner and shareholder value Yield exceptional future profitability Statistically significant double - blind, randomized preliminary trial efficacy data Plan to initiate pivotal study by end of 2023 Strategic collaboration Double - digit revenue share ƚ Ed Ρ ƚ ƌŐ ƚƐ хΨ ϭϬ ŶŶƵ ů ŚLJƉ ƌƚ ŶƐŝŽŶ ŵ ƌ ƚƐ &ŝƌŵǁ ƌ ƵƉŐƌ Ě ƚŽ džŝƐƚŝŶŐ Ɖ ŵ ƌ | Corporate Presentation Q4 2023 3
Orchestra BioMed Development Commercialization Strategic Partners Shared Benefits ^ Ƶƌ ƐƵďƐƚ Ŷƚŝ ů ůŽŶŐ Ͳ ƚ ƌŵ ƌŽLJ ůƚŝ Ɛ KƵƚƐŽƵƌ Žŵŵ ƌ ŝ ůŝnj ƚŝŽŶ DƵůƚŝƉů ƉŝƉ ůŝŶ ŽƉƉŽƌƚƵŶŝƚŝ Ɛ 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 | Corporate Presentation Q4 2023 4
| Corporate Presentation Q4 2023 5 ƚ Ed in collaboration with in collaboration with Virtue SAB >$1.5B $50M equity investment >$2.5B $30M upfront payment $500 - $1,600 *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 ϭϬ Ͳ ϭϱ й ƌŽLJ ůƚLJ W>h^ Ɖ ƌ ƵŶŝƚ Ɖ LJŵ ŶƚƐ Role and Revenue Share Role and Revenue Share Strong Collaborations Position Us for Long - term Success
Advancing High - Impact Pipeline 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 target population are expected to be similar, the type of hypertension treated will likely be isol ate d 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 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 improvi ng 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 had initial interactions with the FDA regarding IDE approval and expect to continue i nteractions regarding clinical trial design and submission requirements ahead of submitting documentation for approval in the se cond 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 breakthr ou gh designation program 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 i nit ial interactions with the PMDA and expect to submit for CTN approval for Coronary ISR and SV studies in the second half of 20 23. 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 ar e currently estimated to be 12 - 18 months for all referenced studies although actual study enrollment timeframes may be longer; f inal primary endpoint results for all studies are at 12 months from enrollment with the exception of Japan Coronary ISR & SV studies, which are expected to be at 6 months from enrollment. 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) ŽƌŽŶ ƌLJ ^ŵ ůů s ƐƐ ů ;^sͿ ϭ Below - the - Knee (BTK) 1 SirolimusEFR Ρ / Microporous Balloon Urology, orthopedics, oncology & other FDA Breakthrough 3 FDA Breakthrough 4 FDA Breakthrough | Corporate Presentation Q4 2023 6
Executive Team: | >350 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 Dev. & Strategy 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 Board members Jason Aryeh Pamela Connealy Eric S. Fain, M.D. Eric A. Rose, M.D. Geoffrey W. Smith | Corporate Presentation Q4 2023 7
BackBeat Cardiac Neuromodulation Therapy Ρ (CNT Ρ ) | Corporate Presentation Q4 2023 8
BackBeat CNT Ρ Overview 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;. Definitions: Ambulatory Systolic Blood Pressure ( aSBP ) and Office Systolic Blood Pressure ( oSBP ) o Hypertension is the leading global risk factor for death and #1 comorbidity in pacemaker population, affecting over 70% of patients 1 o Older population at increased risk for major events & challenges with drug compliance o Additional opportunity to treat high - risk patients not indicated for a pacemaker Unmet Need o Bioelectronic therapy designed to substantially & persistently lower blood pressure o Compatible with standard pacemaker devices & leverages existing treatment paradigm o 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 Innovation Collaboration with | Corporate Presentation Q4 2023 9
| Corporate Presentation Q4 2023 10 Large Global Opportunity for Treating Hypertension in Target Populations *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 High Risk HTN ~0.2% of HTN patients 2,400,000 patients >$8 Billion HTN + Pacemaker ~70% of pacemaker patients 750,000 patients >$2 Billion >$10 Billion Potential Annual Global Market Opportunity* >3.1M Addressable HTN Patients
BackBeat CNT Ρ Designed to Substantially and Persistently Lower Blood Pressure Bioelectronic therapy designed to leverage standard dual - chamber pacemaker o Same implant procedure and lead positions o Large trained physician pool that already implant pacemakers o Same target patient population that already need pacemakers o Leverageable existing reimbursement with robust payment opportunity for novel devices with novel capabilities Mechanism of action o Designed to substantially reduce blood pressure by reducing preload through programmed pacing with short AV delays o Designed to maintain reduction by modulating sympathetic tone and reducing afterload through programmed variable pressure patterns Designed to Substantially Lower BP & Maintain Reduction Reducing Preload Lowers BP Modulating Sympathetic Tone & Reducing Afterload Maintains Reduction in BP SBP (mmHg) Time (s) 155 0 50 100. 150 200 250 300 150 145 140 135 130 1 2 | Corporate Presentation Q4 2023 11
MODERATO II Double - Blind, Randomized Results 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 ) 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 Pre - activation (n=26) 6 months (n=26) 6 Month Mean Pre - activation Mean Significant Reduction in aSBP 24 Hours a Day Significant Reduction in 24 - Hr aSBP and oSBP 1,2 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) Control (n=20) 3 BackBeat CNT (n=26) - 3.1 P =0.17 ƚ Ed Ρ ƐŚŽǁ Ě Ŷ ŽƵƌ ŐŝŶŐ ƌ ƐƵůƚƐ ŝŶ DK Z dK //͕ ƉƌŽƐƉ ƚŝǀ ͕ ŵƵůƚŝ Ͳ Ŷƚ ƌ͕ ƌ ŶĚŽŵŝnj Ě͕ ; ƚ Ed н D Ěŝ ů dŚ ƌ ƉLJ ǀƐ͘ ŽŶƚŝŶƵ Ě D Ěŝ ů dŚ ƌ ƉLJͿ͕ ĚŽƵďů Ͳ ďůŝŶĚ͕ ƉŝůŽƚ ƐƚƵĚLJ ŽĨ Ɖ ŵ ƌ Ɖ ƚŝ ŶƚƐ ǁŝƚŚ Ɖ ƌƐŝƐƚ Ŷƚ ŚLJƉ ƌƚ ŶƐŝŽŶ - 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 | Corporate Presentation Q4 2023 12
BackBeat CNT Ρ Pivotal Trial Design Ƶƌƌ Ŷƚ Ŷƚŝ ŝƉ ƚ Ě ƚƌŝ ů Ě ƐŝŐŶ͗ Efficacy endpoint: Safety endpoint: | Corporate Presentation Q4 2023 13
sŝƌƚƵ Π ^ŝƌŽůŝŵƵƐ ŶŐŝŽ/ŶĨƵƐŝŽŶ Ρ ůůŽŽŶ ;^ Ϳ | Corporate Presentation Q4 2023 14
Virtue® SAB Overview 1 von Birgelen et al. JACC Vol. 59, No. 15, 2012 April 10, 2012:1350 – 61; Virtue SAB has received Breakthrough Device Designation for: 2 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; 3 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 ; 4 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 improvi ng lumen diameter. o Artery disease is the leading cause of death in the U.S. and worldwide o Global paradigm shift toward drug - eluting balloons away from stents for the treatment of coronary indications o Current treatment options are suboptimal and are associated with long - term risks and complications Unmet Need o 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 o Compelling clinical results in multi - center coronary ISR clinical trial with 3 - year follow - up 1 o FDA Breakthrough Device Designation received for indications in coronary ISR 2 , coronary SV 3 and BTK 4 /ŶŶŽǀ ƚŝŽŶ Collaboration with | Corporate Presentation Q4 2023 15
*Total addressable market in 2025 based on company estimates; Definitions: Coronary Artery Disease (CAD), Peripheral Artery D ise ase (PAD), In - stent Restenosis (ISR), Small Vessel (SV, ≤2.5mm), High bleeding Risk De Novo (>2.5mm), Below - the - Knee (BTK, Rutherford 3 - 6, w/out severe comorbidities) . Peripheral BTK ~1,250,000 patients хΨ ϭ͘Ϯ ŝůůŝŽŶ Coronary ISR, SV De Novo, High Bleed Risk ~2,000,000 patients >$1.8 Billion >$3 Billion Annual Global CAD & PAD Market Opportunity* Large Opportunity for Novel AngioInfusion Balloon х ϯ͘Ϯ D ĚĚƌ ƐƐ ďů Θ W W ƚŝ ŶƚƐ Annual Global Opportunity | Corporate Presentation Q4 2023 16
Virtue ® SAB Designed to Enable Angioplasty with Protected Sirolimus Delivery while Leaving No Metal Behind ŶŐŝŽ/ŶĨƵƐŝŽŶ Ρ ůůŽŽŶ Ě ƐŝŐŶ Ě ƚŽ Ŷ ďů ŶŐŝŽƉů ƐƚLJ ǁŝƚŚ ƉƌŽƚ ƚ Ě ĚƌƵŐ Ě ůŝǀ ƌLJ ƚŽ Ěŝů ƚ ǀ ƐƐ ů͕ ƚŽ ŽŶƐŝƐƚ ŶƚůLJ Ě ůŝǀ ƌ ŝŶƚ ŶĚ Ě ĚŽƐ ŶĚ ƚŽ ů ǀ ŶŽ ŵ ƚ ů ď ŚŝŶĚ 1000 100 10 1 0.1 0.01 0.001 Ϭ͘ϬϬϬϭ Required Therapeutic Concentration > 1ng/mg Lung, liver & kidney below level of assay quantification (0.1 ng/mg) in <1 week 0 5 10 15 20 Ϯϱ 30 Coronary Distal Kidney Liver Lun g Time (Days) N = 753 porcine coronary artery segments Sirolimus Tissue Concentration (ng/mg) ^ŝƌŽůŝŵƵƐ &Z Ρ &ŽƌŵƵů ƚŝŽŶ ƉƌŽǀŝĚ Ě džƚ ŶĚ Ě ĨŽ ů ƌ ů Ɛ ŽĨ ƚŚ ƌ Ɖ Ƶƚŝ ů ǀ ůƐ ŽĨ ƐŝƌŽůŝŵƵƐ ƚŚƌŽƵŐŚ ƌŝƚŝ ů Ś ůŝŶŐ Ɖ ƌŝŽĚ ; у ϯϬ Ě LJƐͿ ϭ Precise dose protected in dose unit WƌŽƚ ƚ Ě ůŝǀ ƌLJͬEŽ ƌƵŐ Ž ƚŝŶŐ o No drug loss in transit o No time limits on delivery o No drug coating particulates Inflated to deliver dose through micropores 1 Granada et al. EuroIntervention 2016;12:740 - 747 | Corporate Presentation Q4 2023 17
Compelling SABRE Trial Results in Coronary ISR Patients ϭ s ƌŚ LJ ƚ ů͘ : ƌĚŝŽǀ Ɛ /Ŷƚ ƌǀ ϮϬϭϳ K ƚ Ϯϯ ͖ ϭϬ ; ϮϬ Ϳ͗ ϮϬϮϵ Ͳ ϮϬϯϳ ͘ K/͗ ϭϬ͘ϭϬϭϲ ͬũ͘ũ ŝŶ͘ ϮϬϭϳ͘Ϭϲ͘ϬϮϭ ͘ Ϯ 'ƌ Ŷ Ě ϯ Ͳ z ƌ ůŝŶŝ ů Z ƐƵůƚƐ d d ϮϬϭϴ ͘ ϯ Ͳ z ƌ ^ Z dƌŝ ů ůŝŶŝ ů Z ƉŽƌƚ ŽŶ Ĩŝů ͘ ĨŝŶŝƚŝŽŶƐ͗ d ƌŐ ƚ ů ƐŝŽŶ Ĩ ŝůƵƌ ;d>&Ϳ͕ ů ƚ ůƵŵ Ŷ ůŽƐƐ ;>>>Ϳ͕ ƚ ƌŐ ƚ ů ƐŝŽŶ ƌ ǀ Ɛ Ƶů ƌŝnj ƚŝŽŶ ;d>ZͿ ŶĚ DLJŽ ƌĚŝ ů /ŶĨ ƌ ƚŝŽŶ ;D/Ϳ͘ 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 Ϭ й E ǁ d>Z ď ƚǁ Ŷ ϭ ƚŽ ϯ LJ ƌƐ 5.6% Ϯ͘ϴ й 2.8% 2.8% 0% 0% 0% Ϭ й 0% Ϭ й 0% 2.8% Cardiac Death TV - MI TLR d>& Event Rates (%) ϯϬ Ě LJƐ ϭ Ͳ LJ ƌ ϯ Ͳ LJ ƌƐ Per Protocol 4 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 Q4 2023 18
Virtue® SAB Coronary ISR US Pivotal Trial 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 ^ƚƵĚLJ Kďũ ƚŝǀ WƌŽǀŝĚ ĚĚŝƚŝŽŶ ů ůŝŶŝ ů Ě ƚ ŝŶ ƐƵƉƉŽƌƚ ŽĨ ƵƐ ŝŶ ĚŽƵďů Ͳ ů LJ ƌ ŽƌŽŶ ƌLJ /^Z ǁŝƚŚŽƵƚ ŽŶĨŽƵŶĚŝŶŐ d>& Ɖ ƌĨŽƌŵ Ŷ ƌ ƐƵůƚƐ ŝŶ ƐŝŶŐů Ͳ ů LJ ƌ ŽƌŽŶ ƌLJ /^Z R < LJ /Ŷ ůƵƐŝŽŶ Zs Ϯ͘ϱ ƚŽ ϰ͘Ϭ ŵŵ͕ ф ϯϬ й ^ ;ǀƐ͘ Zs Ϯ͘ϱ ƚŽ ϯ͘ϱ ͕ ф ϰϬ й ^ ^ Z ϭ dƌŝ ů Ϳ Randomized Study Arm to Support Regulatory Approval: Single - Layer Coronary ISR Non - Randomized Study Arm: Double - Layer Coronary ISR Primary Endpoint 12 Month Primary Endpoint 12 - 18 Months Enrollment < LJ /Ŷ ůƵƐŝŽŶ Zs Ϯ͘ϱ ƚŽ ϰ͘Ϭ ŵŵ͕ ф ϯϬ й ^ ;ǀƐ͘ Zs Ϯ͘ϱ ƚŽ ϯ͘ϱ ͕ ф ϰϬ й ^ ^ Z ϭ dƌŝ ů Ϳ 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. ŽƵďů Ͳ ďůŝŶĚ͕ ŵƵůƚŝ Ͳ Ŷƚ ƌ͕ ƉƌŽƐƉ ƚŝǀ ͕ ƌ ŶĚŽŵŝnj Ě ŽŶƚƌŽůů Ě ƐƚƵĚLJ ŝŶ Ɖ ƚŝ ŶƚƐ ǁŝƚŚ ƐŝŶŐů Ͳ ů LJ ƌ ŽƌŽŶ ƌLJ /^Z Prospective, single - arm, controlled study in patients with double - layer coronary ISR Virtue® SAB N=100 Target Lesion Failure (CD, TV - MI and TLR) at 12 months Virtue® SAB N=200 PBA N=100 Wƌŝŵ ƌLJ ŶĚƉŽŝŶƚ Target Lesion Failure (CD, TV - MI and TLR) at 12 months ͮ ŽƌƉŽƌ ƚ Wƌ Ɛ Ŷƚ ƚŝŽŶ Y ϰ ϮϬϮϯ 19
Upcoming Anticipated Milestones BackBeat CNT HTN + Pacemaker 1 st Pt. Enrollment Planned Regulatory Milestones Planned Clinical Milestones ƚ Ed ,dE н W ŵ ƌ & / ƉƉƌŽǀ ů Virtue SAB Virtue - ISR US FDA IDE Approval Japan PMDA CTN Coronary ISR Approval 1 Japan PMDA CTN Coronary SV Approval 1 ϭ dŝŵŝŶŐ Ɛƚŝŵ ƚ Ě ŶĚ ƐƵďũ ƚ ƚŽ d ƌƵŵŽ dž ƵƚŝŽŶ ƐŝŶ d ƌƵŵŽ ŽŶƚƌŽůƐ Ě ǀ ůŽƉŵ Ŷƚ ŽĨ sŝƌƚƵ ^ ĨŽƌ ^s ŝŶĚŝ ƚŝŽŶ ŶĚ ĨŽƌ /^ Z ŝ Ŷ : Ɖ Ŷ͖ Ύ/Ŷŝƚŝ ƚŝŽŶ ŽĨ ƚŚ sŝƌƚƵ /^Z Ͳ h^ ƉŝǀŽƚ ů ƐƚƵĚLJ ǁŝůů ď ƉŽƐƚƉŽŶ Ě ƵŶƚŝů ϮϬϮϰ ǁŚŝů Kƌ Ś Ɛƚƌ ŝŽD Ě ŶĚ d ƌƵŵŽ ůŝŐŶ ŽŶ Ɖ ƌƚŶ ƌƐŚŝƉ ƌ ƐƚƌƵ ƚƵƌŝŶŐ͘ /Ĩ Ŷ ŐŽƚŝ ƚŝŽŶƐ ƌ ŶŽƚ ŽŵƉů ƚ Ě ƚŽ ƚŚ Ɛ ƚŝƐĨ ƚŝŽŶ ŽĨ Kƌ Ś Ɛƚƌ ŝŽD Ě Žƌ ƚŽ ƚŚ Ɛ ƚŝƐĨ ƚŝŽŶ ŽĨ d ƌƵŵŽ͕ ůŝŶŝ ů ŶĚ Ě ǀ ůŽƉŵ Ŷƚ ĨĨŽƌƚƐ͕ ŶĚ Žŵ ŵ ƌ ŝ ůŝnj ƚŝŽŶ Ɖů ŶƐ ĨŽƌ sŝƌƚƵ ^ ŶĚͬŽƌ ƚŚ Kƌ Ś Ɛƚƌ ŝŽD Ě ƌ ů ƚŝŽŶƐŚŝƉ ǁŝƚŚ d ƌƵŵŽ ŵ LJ ŽŶƚŝŶƵ ƚŽ ď Ěǀ ƌƐ ůLJ ŝŵƉ ƚ Ě͘ Virtue SAB Virtue - ISR US 1st Pt. Enrollment* CNT - HF and SirolimusEFR Program Updates | Corporate Presentation Q4 2023 20
Bringing Medical Innovations to Life Through Partnerships dǁŽ WƌŽŐƌ ŵƐ d ƌŐ ƚŝŶŐ > ƌŐ D ƌ ƚƐ ^ƵƉƉŽƌƚ Ě ďLJ WƌŽŵŝƐŝŶŐ dƌŝ ů ƚ Ŷƚ ƌŝŶŐ WŝǀŽƚ ů dƌŝ ůƐ Strong Balance Sheet & Committed Strategic & Financial Investors W ƌƚŶ ƌƐŚŝƉ Ͳ Ŷ ďů Ě ƵƐŝŶ ƐƐ DŽĚ ů Θ ŽŵƉůŝƐŚ Ě > Ě ƌƐŚŝƉ d ŵ Designed to accelerate innovation to patients, enable pipeline expansion and drive strong partner and shareholder value Highly experienced team with proven track record of innovation and execution Virtue® SAB BackBeat CNT Ρ ∼ $3 billion annual market 3 - year pilot study results show potential safety & efficacy Partnered with хΨ ϭϬ ďŝůůŝŽŶ ŶŶƵ ů ŵ ƌ ƚ Z ŶĚŽŵŝnj Ě ͕ ŽŶƚƌŽůů Ě ƐƚƵĚLJ ƐŚŽǁƐ ĨĨŝ LJ ƉŽƚ Ŷƚŝ ů Žůů ďŽƌ ƚŝŽŶ ǁŝƚŚ | Corporate Presentation Q4 2023 Ϯϭ