Ligand to invest $35 million in exchange for a tiered royalty on future
sales of Orchestra’s AVIM therapy and Virtue SAB, plus $5 million in an
equity private placement
Medtronic to invest $10 million via equity private placement and $20
million via a secured subordinated promissory note convertible to prepaid
revenue share
Medtronic and Orchestra BioMed expand strategic collaboration to provide a
pathway for AVIM therapy-enabled leadless pacemakers
NEW HOPE, Pa., July 31, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings,
Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical
company accelerating high-impact technologies to patients through risk-reward
sharing partnerships, today announced that the Company has secured $70 million
in new capital from Ligand Pharmaceuticals Incorporated (Nasdaq: LGND)
(“Ligand”) and Medtronic plc (NYSE: MDT) (“Medtronic”) to advance its
late-stage partnered cardiology programs.
Simultaneously, Orchestra BioMed and Medtronic, which have an existing
strategic collaboration for atrioventricular interval modulation (“AVIM”)
therapy for the treatment of uncontrolled hypertension in pacemaker-indicated
patients, have amended their agreement to include the potential future
development of AVIM therapy-enabled leadless pacemakers. Unlike traditional
pacemakers that are placed in a patient’s chest with leads (wires) running to
the heart, minimally invasive Medtronic Micra™ leadless pacemakers are
implanted directly into the heart, reducing potential sources of
complications.
Ligand $40 Million Investment
Todd Davis, Chief Executive Officer of Ligand, commented: “We
are pleased to partner with Medtronic and Orchestra BioMed in this important
endeavor. This investment expands our pipeline of development-stage products
and demonstrates our confidence in Orchestra BioMed’s scientific advancements,
as well as the strong capabilities of its partner, Medtronic. We are proud to
support Orchestra BioMed as they develop novel high-impact, device-based
therapies such as AVIM therapy and Virtue SAB targeting high-risk patient
populations with hypertension and arterial disease, two of the most
significant global health challenges.”
Under the terms of the agreement, Ligand will pay $20 million to Orchestra
BioMed at closing, with an additional $15 million to be funded, subject to
certain conditions precedent, at the nine-month anniversary of the transaction
closing date. Ligand has also agreed to invest an additional $5 million to
purchase shares of the Company’s common stock in an equity private placement
at the public offering price per share in Orchestra BioMed’s next public
offering of its equity securities. In exchange, Ligand will receive a low
double-digit royalty on the first $100 million in commercial revenues from
Orchestra’s AVIM therapy and Virtue SAB programs in all indications. Ligand
will also earn a mid-single-digit royalty on annual revenues exceeding $100
million from AVIM therapy in the uncontrolled hypertension and increased
cardiovascular risk indication and from Virtue SAB in coronary artery disease
indications.
Medtronic $30 Million Additional Investment & Future Leadless AVIM
Therapy Device Development
Robert C. Kowal, M.D., Ph.D., Vice President and General Manager of Cardiac
Pacing Therapies within the Medtronic Cardiac Rhythm Management operating
unit, commented:
“Our expanded investment in Orchestra BioMed reflects confidence in their
clinical progress. Broadening our collaboration to include integrating AVIM
therapy into future leadless pacing technology reaffirms our commitment to
transform care for patients who need pacing therapy and have uncontrolled
hypertension.”
David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed,
added:
“Ligand has been one of the inspirations for our partnership-driven approach
to creating long-term, capital-efficient value through royalty-based
collaborations. We are thrilled to welcome them as a strategic capital
partner. Ligand’s decision to invest in our partnered programs and our team
reflects our shared conviction in the transformative potential of both AVIM
therapy and Virtue SAB—our late-stage flagship technologies aimed to address
important unmet medical needs in large, established global markets. This
transaction provides foundational financial support to enable our potential
achievement of key value-creating milestones for both of our high-impact
clinical programs.”
Subject to the terms of the agreement, Medtronic’s $30 million additional
investment commitment to Orchestra BioMed includes a $10 million agreement to
purchase shares of the Company’s common stock in a private placement at the
public offering price in the Company’s next public offering of its equity
securities. Medtronic also made a $20 million commitment to purchase a
five-year term secured subordinated promissory note, to be funded in nine
months, which automatically converts to a prepaid revenue share upon U.S. Food
and Drug Administration (“FDA”) approval of AVIM therapy. The prepaid revenue
share will be credited back to Medtronic at a low double-digit percentage of
actual AVIM therapy revenue share paid to Orchestra BioMed, up to $40 million
in cumulative revenue share.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company enabling scientific advancement by
supporting the clinical development of high-value medicines through financing,
technology licensing, or both. Our business model seeks to generate value for
stockholders by creating a diversified portfolio of biotech and pharmaceutical
product revenue streams supported by an efficient and low corporate cost
structure. We fund programs in mid- to late-stage drug development in return
for economic rights, purchase royalty rights in development-stage or
commercial biopharmaceutical products, and license our technologies to help
partners discover and develop medicines. We partner with pharmaceutical
companies to leverage their strengths in late-stage development, regulatory
management, and commercialization. Our Captisol® platform technology is a
chemically modified cyclodextrin designed to optimize the solubility and
stability of drugs. Our NITRICIL™ platform enables tunable dosing with
adjustable drug release profiles across a broad range of indications. We have
established multiple alliances, licenses and other business relationships with
leading pharmaceutical companies including Amgen, Merck, Pfizer, Jazz, Gilead
Sciences and Baxter International. For more information, please visit
www.ligand.com. Follow Ligand on
X and
LinkedIn.
We use our investor relations website and X as a means of disclosing material
non-public information and for complying with our disclosure obligations under
Regulation FD. Investors should monitor our website and our X account, in
addition to following our press releases, SEC filings, public conference calls
and webcasts.
About Orchestra BioMed
Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company
accelerating high-impact technologies to patients through risk-reward sharing
partnerships with leading medical device companies. The Company’s
partnership-enabled business model focuses on forging strategic collaborations
to drive global commercialization of products it develops. Orchestra BioMed’s
lead product candidate is AVIM therapy for the treatment of hypertension, the
leading risk factor for death worldwide. The Company is also developing Virtue
SAB for the treatment of atherosclerotic artery disease, the leading cause of
mortality worldwide. Orchestra BioMed has a strategic collaboration with
Medtronic for development and commercialization of AVIM therapy for
hypertension in pacemaker-indicated patients, and a strategic partnership with
Terumo for development and commercialization of Virtue SAB for artery disease.
The Company has received four Breakthrough Device Designations from the FDA
across these two core programs. For more information, please visit
www.orchestrabiomed.com
and follow us on
LinkedIn.
References to Websites and Social Media Platforms
References to information included on, or accessible through, websites and
social media platforms do not constitute incorporation by reference of the
information contained at or available through such websites or social media
platforms, and you should not consider such information to be part of this
press release.
About AVIM Therapy
AVIM therapy is an investigational therapy compatible with standard
dual-chamber pacemakers designed to substantially and persistently lower blood
pressure. It has been evaluated in pilot studies in patients with hypertension
who are also indicated for a pacemaker. MODERATO II, a double-blind,
randomized pilot study, showed that patients treated with AVIM therapy
experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood
pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six
months compared to control patients. In addition to reducing blood pressure,
clinical results using AVIM therapy demonstrate improvements in cardiac
function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with
atrioventricular interval modulation for Blood prEssure treAtmenT) global
pivotal study will further evaluate the safety and efficacy of AVIM therapy in
lowering blood pressure in patients who have systolic blood pressure above
target despite anti-hypertensive medication and who are indicated for or have
recently received a dual-chamber cardiac pacemaker. AVIM therapy has been
granted Breakthrough Device Designation by the FDA for the treatment of
uncontrolled hypertension in patients who have increased cardiovascular risk.
About Virtue SAB
Virtue SAB is designed to deliver a proprietary extended-release formulation
of sirolimus (SirolimusEFR™) through a non-coated microporous AngioInfusion™
Balloon that protects the drug in transit to consistently deliver a large
liquid dose, overcoming certain limitations of drug-coated balloons.
SirolimusEFR delivered by Virtue SAB has been shown in published preclinical
series involving hundreds of arterial deliveries to achieve sustained tissue
levels well above the known therapeutic tissue concentration for inhibiting
restenosis (1 ng/mg tissue) for the approximately 30-day critical healing
period. Virtue SAB demonstrated positive three-year clinical data in coronary
ISR in the SABRE study, a multi-center prospective, independent
core-lab-adjudicated clinical study of 50 patients conducted in Europe. Virtue
SAB has been granted Breakthrough Device Designation by the FDA for specific
indications relating to coronary ISR, coronary small vessel disease, and
peripheral artery disease below-the-knee.
Forward-Looking Statements
This press release contains 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,” “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 enrollment, implementation and design of the Company’s planned
and ongoing pivotal trials, realization of the clinical and commercial value
of the Company’s product candidates, the potential safety and efficacy of the
Company’s product candidates, the ability of the Company’s partnerships to
accelerate clinical development, and the Company’s ability to satisfy funding
and closing conditions of the transactions described herein. These statements
are based on various assumptions and on the current expectations of the
Company’s management and are not predictions of actual performance. Actual
events and circumstances are difficult or impossible to predict and may differ
from assumptions, many of which are beyond the Company’s control. 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 and ongoing regulation of such candidates, if
approved; 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 for the year ended
December 31, 2024 (filed March 31, 2025) and Quarterly Report on Form 10-Q for
the quarter ended March 31, 2025 (filed May 12, 2025). The Company cautions
against placing undue reliance on these forward-looking statements, which
speak only as of the date of this press release, and undertakes no obligation
to update any forward-looking statements except as required by law.
Contacts
For Orchestra BioMed:
Investors:
Silas Newcomb
Snewcomb@orchestrabiomed.com
Media:
Kelsey Kirk-Ellis
Kkirkellis@orchestrabiomed.com
For Ligand:
Investors:
Melanie Herman
investors@ligand.com
(858) 550-7761
Media:
Kellie Walsh
media@ligand.com
(914) 315-6072