Orchestra BioMed
AVIM Therapy R&D DAY
June 11, 2024
Bringing medical innvation to life
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 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 1A. Risk Factors" in the Company's annual report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 27, 2024 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 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.
2 | Orchestra BioMed R&D Day 2024
Agenda and Speakers
Agenda
Introduction and Orchestra BioMed Overview, David Hochman
Unmet Hypertension Treatment Need in Older High-Risk Patients, David Kandzari, M.D.
Evidence Supporting AVIM Therapy Mechanism of Action, Vivek Reddy, M.D.
Clinical Data from the MODERATO I and II Studies, Vivek Reddy, M.D.
Rationale and Design of the BACKBEAT Global Pivotal Study, David Kandzari, M.D.
Closing Remarks and Q&A, David Hochman
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Presenters
David Hochman | David Kandzari, M.D. | Vivek Reddy, M.D. |
CEO, Chairman, Founder | BACKBEAT Study Co-PI, | BACKBEAT Study Advisor, |
Orchestra BioMed | Piedmont Heart Institute | Mount Sinai Hospital |
Q&A
Darren Sherman | Avi Fischer, M.D. |
COO, President, Founder | SVP, Medical Affairs and Innovation |
Orchestra BioMed | Orchestra BioMed |
Orchestra BioMed Overview
David Hochman
Chief Executive Officer, Founder Chairman, Orchestra BioMed
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Orchestra BioMed Executive Overview
Partnership-enabled business model designed to:
Accelerate innovation to patients & yield exceptional future profitability
Lead Program
Atrioventricular Interval Modulation (AVIM) Therapy
Targets >$10B annual hypertension markets
Statistically significant efficacy data from double-blind, randomized pilot study
BACKBEAT global pivotal study now enrolling
Pipeline Program
Virtue® Sirolimus AngioInfusion Balloon (SAB)
Targets >$4B annual artery disease markets
Strong 3-yearmulti-center pilot study efficacy data
Conditional IDE approved for coronary pivotal study
Strategic collaboration | Strategic collaboration |
Double-digit revenue share | Double-digit revenue share |
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Orchestra BioMed's Partnership-Enabled Model Benefits All
Orchestra BioMed | Shared Benefits | Strategic Partners | ||||
Development | Innovation | Commercialization | ||||
Secure substantial | Improve | Enable new growth | ||||
long-term royalties | patient lives | opportunities | ||||
Outsource | Accelerate | Outsource | ||||
commercialization | development | development | ||||
Enable multiple pipeline | Leverage expertise | Minimize | ||||
opportunities | & resources | P&L dilution |
6 | Orchestra BioMed R&D Day 2024
A Renaissance is Happening
Now…
Renaissance (n):
A revival or renewed interest in something; learning from the past to create something better for the future
Art
Architecture
Science
Music
Device innovation?
This Photoby Unknown Author is licensed under CCBY-SA
The Renaissance of Orchestra
orchḗstra
Ancient Greece: the circular space in front of the
stage where the chorus performed
The chorus in Classical Greek drama was a group of actors who
described and
commented upon the main action of a play with song, dance, and recitation
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Orchestra
Renaissance Italy: a group of musicians performing a composition with pre-specified instrumentation
Claudio Monteverdi (1567-1643)
The "Father" of the Symphony Orchestra
In order for his music to be replicated exactly as he composed it; he required it be played with specific instrumentation:
15 viols of different sizes; 2 violins; 4 flutes, 2 large and 2 medium; 2 oboes, 2 cornetts, 4 trumpets, 5 trombones, a harp, 2 harpsichords, and 3 small organs.
"In the history of Western musical tradition, the evolution of symphony orchestra to its modern form can be seen as an apotheosis of instrumental music."
An Orchestra Succeeds Through Collaboration
What more miraculous creation of mankind is there than the symphony orchestra - a hundred musicians collaborating flawlessly in the creation of a single sonority from moment to moment… We tend to take for granted the skill and sensitivity of such a performing organism, and we should take time to marvel afresh that such a joint effort is possible for human beings, so rich in communication, beauty and meaning.
Klaus George Roy
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Orchestra BioMed
Our Symphony is
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Disclaimer
Orchestra Biomed Holdings Inc. published this content on 11 June 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 12 June 2024 19:48:06 UTC.