Full Press Release Details
Ligand and Medtronic Commit $70 Million in Strategic
Capital to Orchestra BioMed
Ligand to invest $35 million in exchange for a tiered royalty on future sales of Orchestra's AVIM
therapy and Virtue SAB and an additional $5 million in an equity private placement
to invest $10 million in an equity private placement and an additional $20 million in a
secured subordinated promissory note convertible
to prepaid revenue share
Medtronic and Orchestra BioMed expand strategic collaboration to provide pathway for
development of AVIM therapy-enabled leadless pacemakers
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 (or 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
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."
Hochman, Chairman and Chief Executive Officer of Orchestra BioMed stated, "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."
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 in commercial revenues from AVIM therapy in
the uncontrolled hypertension and increased cardiovascular risk indication and Virtue SAB in coronary artery disease indications.
Medtronic $30 million Additional Investment
& Future Leadless AVIM Therapy Device Development
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."
Hochman added, "Medtronic continues to be an outstanding partner for the AVIM therapy program. We believe their $30 million
additional commitment to Orchestra BioMed reflects their belief in the clinical and commercial potential for this therapy to benefit patients
with uncontrolled hypertension and increased cardiovascular risk in the pacemaker population. Expanding our existing collaboration to
provide for potential future integration of AVIM therapy into a leadless pacemaker system deepens our strategic alignment and creates
a potential pathway for patients to benefit from both AVIM therapy and cutting-edge leadless pacing technology, simultaneously."
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 through supporting the clinical development of high-value medicines. Ligand does this by providing financing,
licensing our technologies or both. Ligand's business model seeks to generate value for stockholders by creating a diversified
portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure.
Ligand's goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable and diversified
manner. Ligand's business model is based on funding programs in mid- to late-stage drug development in return for economic rights,
purchasing royalty rights in development stage or commercial biopharmaceutical products and licensing its technology to help partners
discover and develop medicines. Ligand partners with other pharmaceutical companies to attempt to leverage what they do best (late-stage
development, regulatory management and commercialization) in order to generate revenue. Ligand operates two infrastructure-light royalty
generating technology IP platform technologies. Ligand's Captisol platform technology is a chemically modified cyclodextrin
with a structure designed to optimize the solubility and stability of drugs. Ligand's NITRICIL platform technology facilitates
tunable dosing, permitting an adjustable drug release profile to allow proprietary formulations that target a broad range of indications.
Ligand has established multiple alliances, licenses and other business relationships with the world's 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.
Ligand uses its 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
BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing
partnerships with leading medical device companies. Orchestra BioMed's partnership-enabled business model focuses on forging strategic
collaborations with leading medical device companies to drive successful 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.
Orchestra BioMed 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, one of the largest medical device companies in the world, for development
and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership
with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease.
The Company has received four Breakthrough Device Designations from the FDA across these two core programs, reflecting the significant
potential of its technologies to address high unmet needs in cardiovascular care. For further information about Orchestra BioMed, please
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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 when 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.
Virtue SAB is designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR through a non-coated microporous