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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13
OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): November 5, 2026
ORCHESTRA BIOMED
HOLDINGS, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction
of incorporation) |
001-39421
(Commission
File Number) |
92-2038755
(IRS Employer
Identification No.) |
|
150 Union Square Drive
New Hope, Pennsylvania 18938
(Address of principal executive offices, including zip code)
Registrant’s telephone number, including area code: (215) 862-5797
(Former name or former address, if changed since last report)
|
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
|
Title of each
class |
Trading Symbol(s) |
Name of each
exchange on which
registered |
| Common stock, par value $0.0001 per share |
OBIO |
The Nasdaq Stock Market LLC |
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).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. ¨
Item 1.01. Entry into a Material Definitive Agreement.
On November 5, 2026, Orchestra BioMed Holdings, Inc.
(the “Company”) entered into an underwriting agreement (the “Underwriting Agreement”)
with Piper Sandler & Co. and TD Securities (USA) LLC as the representatives of the several underwriters named therein (the “Underwriters”),
relating to an underwritten public offering (the “Offering”) of an aggregate of 15,000,000 shares of the Company’s
common stock, par value $0.0001 per share (“Common Stock”) at a public offering price of $5.00 per share. Under
the terms of the Underwriting Agreement, the Company also granted to the Underwriters an option, exercisable in whole or in part at any
time for a period of 30 days from the date of the Underwriting Agreement, to purchase up to 2,250,000 additional shares of Common Stock,
which was exercised in full on November 6, 2026.
The Offering was made pursuant to the Company’s
registration statement on Form S-3 (File No. 333-279430), previously filed with the Securities and Exchange Commission (the
“SEC”) on May 15, 2024, and declared effective on May 24, 2024, a base prospectus dated May 24,
2024 included as part of the registration statement, a preliminary prospectus supplement, dated November 5, 2026 and filed with the
SEC on November 5, 2026, and a final prospectus supplement, dated November 5, 2026, and filed with the SEC on November 6,
2026.
Gross proceeds from the Offering were approximately
$86.3 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company. The Company
intends to use the net proceeds from the Offering, together with its existing cash and cash equivalents, to fund the Company’s Atrioventricular
Interval Modulation Therapy program and the execution of the BACKBEAT global pivotal trial involving patients with uncontrolled hypertension
who are indicated for a dual-chamber pacemaker and to fund its Virtue® Sirolimus AngioInfusion™ Balloon (“Virtue
SAB”) program and the Virtue SAB in the Treatment of Coronary In-Stent Restenosis Trial, as well as research and clinical
development of other current or additional product candidates, and the remainder for working capital and other general corporate purposes.
The Offering closed on November 9, 2026.
The Underwriting Agreement contains customary
representations, warranties and covenants made by the Company. It also provides for customary indemnification by each of the Company and
the Underwriters, severally and not jointly, for losses or damages arising out of or in connection with the Offering, including for liabilities
under the Securities Act of 1933, as amended (the “Securities Act”), other obligations of the parties and termination
provisions. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such
agreement and as of specific dates, were solely for the benefit of the parties to the Underwriting Agreement and may be subject to limitations
agreed upon by the contracting parties.
The foregoing description of the Underwriting
Agreement does not purport to be complete and is qualified in its entirety by reference to the Underwriting Agreement, which is filed
as Exhibit 1.1 to this Current Report on Form 8-K (this “Current Report”). The opinion of Paul Hastings
LLP, counsel to the Company, relating to the validity of the shares of Common Stock to be issued in the Offering is filed herewith as
Exhibit 5.1.
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 regarding the Offering, including
the anticipated use of proceeds from the Offering. 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; risks related to regulatory approval of the Company’s commercial product candidates
and ongoing regulation of the Company’s product 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,
2025, which was filed with the SEC on March 12, 2026, as such discussion may be updated from time to time by subsequent filings the
Company may make with the SEC, as well as the risks identified in the registration statement and the preliminary prospectus supplement
relating to the Offering.
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 7.01. Regulation FD Disclosure.
On November 5, 2026, the Company issued a
press release announcing the launch of the Offering, which is attached as Exhibit 99.1 to this Current Report and is incorporated
herein by reference.
On November 5, 2026, the Company issued a
press release announcing the pricing of the Offering, which is attached as Exhibit 99.2 to this Current Report and is incorporated
herein by reference.
The information in Item 7.01 of this Current Report, including Exhibits
99.1 and 99.2 attached hereto, are 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 Exhibits 99.1 and 99.2, shall not be incorporated by reference
into any filing under the Securities Act 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 |
| 1.1 |
|
Underwriting Agreement, dated as of November 5, 2026, by and among Orchestra BioMed Holdings, Inc., Piper Sandler & Co. and TD Securities (USA) LLC. |
| |
|
|
| 5.1 |
|
Opinion of Paul Hastings LLP. |
| |
|
|
| 23.1 |
|
Consent of Paul Hastings LLP (included in Exhibit 5.1). |
| |
|
|
| 99.1 |
|
Press Release, dated November 5, 2026. |
| |
|
|
| 99.2 |
|
Press Release, dated November 5, 2026. |
| |
|
|
| 104 |
|
Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL). |
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. |
| |
|
|
| Date: November 9, 2026 |
By: |
/s/ Andrew Taylor |
| |
|
Name: Andrew Taylor |
| |
|
Title: Chief Financial Officer |
Exhibit 99.1
Orchestra BioMed Announces Proposed Public Offering
NEW HOPE, Pa., November 5, 2026 (GLOBE NEWSWIRE) — Orchestra
BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical innovation company
accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies,
announced today that it has commenced an underwritten public offering of shares of its common stock (the “Offering”). All
of the securities are being offered by the Company. In addition, the Company intends to grant the underwriters a 30-day option to purchase
up to an additional 15% of shares of its common stock sold in the Offering at the public offering price per share, less underwriting
discounts and commissions. The Offering is subject to market and other conditions, and there can be no assurance as to whether or when
the Offering may be completed, or as to the actual size or terms of the Offering.
The Company intends to use the net proceeds it receives from the Offering,
together with its existing cash and cash equivalents, to fund the Company’s Atrioventricular Interval Modulation Therapy (“AVIM
Therapy”) program and the execution of the BACKBEAT global pivotal trial involving patients with uncontrolled hypertension who
are indicated for a dual-chamber pacemaker (the “Backbeat Trial”) and to fund its Virtue® Sirolimus AngioInfusion Balloon
(“Virtue SAB”) program and the Virtue SAB in the Treatment of Coronary In-Stent Restenosis Trial (the “Virtue Trial”),
as well as research and clinical development of other current or additional product candidates, and the remainder for working capital
and other general corporate purposes.
Piper Sandler and TD Cowen are acting as joint bookrunning managers
for the Offering. BTIG is acting as a bookrunner.
The securities described above are being offered pursuant to a shelf
registration statement on Form S-3 (File No. 333-279430) that was filed with the Securities and Exchange Commission (the “SEC”)
on May 15, 2024 and declared effective on May 24, 2024. The Offering is being made only by means of a prospectus supplement
and an accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement related to and describing
the terms of the Offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies
of the preliminary prospectus supplement and an accompanying prospectus related to the Offering may also be obtained, when available,
from: Piper Sandler & Co., Attention: Prospectus Department, 350 North 5th Street, Suite 1000, Minneapolis, Minnesota
55401, or by telephone at (800) 747-3924, or by email at prospectus@psc.com; or TD Securities (USA) LLC, Attention: Broadridge Financial
Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by email at TDManualrequest@broadridge.com.
This press release shall not constitute an offer to sell or the solicitation
of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or
sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Orchestra BioMed
Orchestra BioMed is a biomedical innovation company accelerating high-impact
technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two
flagship product candidates - AVIM Therapy and Virtue SAB - are currently undergoing pivotal clinical trials for their lead indications.
AVIM Therapy is a bioelectronic treatment for hypertension, the leading
risk factor for death worldwide, and is designed to be delivered by a pacemaker and achieve immediate, substantial and sustained reductions
in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic (NYSE: MDT),
one of the largest medical device companies in the world and the global leader in cardiac pacing therapies, for the development and commercialization
of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has two FDA Breakthrough
Device Designations. The BACKBEAT Trial evaluating AVIM Therapy in this population has completed enrollment.
Virtue SAB is a first-of-its-kind, non-coated drug delivery AngioInfusion™
balloon system designed to infuse a large liquid dose of proprietary extended-release formulation of sirolimus, SirolimusEFR™,
for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB exceeded the published pharmacokinetics
of leading limus drug-eluting stents and demonstrated positive three-year clinical data in coronary In-Stent Restenosis in the SABRE
study, a multi-center prospective, independent core lab-adjudicated pilot clinical study of 50 patients conducted in Europe. Virtue SAB
has been granted Breakthrough Device Designation by the FDA for the treatment of coronary in-stent restenosis, coronary small vessel
disease and below-the-knee peripheral artery disease, in each case, within specified parameters. The Virtue Trial is currently enrolling
patients.
Forward-Looking Statements
Certain statements included in this press release 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 regarding the proposed
Offering, including the completion and timing of the Offering, the anticipated use of proceeds from the Offering and the expectation
to grant the underwriters a 30-day option to purchase additional shares . These statements are based on various assumptions, whether
or not identified in this press release, 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
commercial product candidates and ongoing regulation of the Company’s product 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, 2025, which was filed with the SEC on March 12, 2026, as such discussion may be updated from time to
time by subsequent filings the Company may make with the SEC, as well as the risks identified in the registration statement and the preliminary
prospectus supplement relating to the Offering.
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.
Investor Contact
Silas Newcomb
Orchestra BioMed
snewcomb@orchestrabiomed.com
Media Contact
Nina Premutico
Orchestra BioMed
npremutico@orchestrabiomed.com
Exhibit 99.2
Orchestra BioMed Announces Pricing of Public Offering
NEW HOPE, Pa., November 5, 2026 (GLOBE NEWSWIRE) — Orchestra
BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical innovation company
accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies,
announced today the pricing of an underwritten public offering of 15,000,000 shares of its common stock at a price to the public of $5.00
per share (the “Offering”). In addition, the Company granted the underwriters a 30-day option to purchase up to an additional
2,250,000 shares of its common stock at the public offering price per share, less underwriting discounts and commissions. All of the securities
are being offered by the Company. The Offering is expected to close on November 9, 2026, subject to customary closing conditions.
The gross proceeds from the Offering, before deducting underwriting
discounts and commissions and estimated offering expenses, are expected to be $75.0 million, assuming no exercise of the underwriters’
option. The Company intends to use the net proceeds from the Offering, together with its existing cash and cash equivalents, to fund the
Company’s Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) program and the execution of the BACKBEAT global
pivotal trial involving patients with uncontrolled hypertension who are indicated for a dual-chamber pacemaker (the “BACKBEAT Trial”)
and to fund its Virtue® Sirolimus AngioInfusion™ Balloon (“Virtue SAB”) program and the Virtue SAB in the Treatment
of Coronary In-Stent Restenosis Trial (the “Virtue Trial”), as well as research and clinical development of other current
or additional product candidates, and the remainder for working capital and other general corporate purposes.
Piper Sandler and TD Cowen are acting as joint bookrunning managers
for the Offering. BTIG is acting as a bookrunner and H.C. Wainwright & Co. is acting as lead manager for the Offering.
The securities described above are being offered pursuant to a shelf
registration statement on Form S-3 (File No. 333-279430) that was filed with the Securities and Exchange Commission (the “SEC”)
on May 15, 2024 and declared effective on May 24, 2024. A preliminary prospectus supplement relating to the Offering has been,
and a prospectus supplement relating to the Offering will be, filed with the SEC. The Offering is being made only by means of a prospectus
supplement and an accompanying prospectus that form a part of the registration statement. Copies of the prospectus supplement and accompanying
prospectus relating to the Offering may be obtained free of charge on the SEC’s website located at www.sec.gov. Copies of the prospectus
supplement and accompanying prospectus relating to the Offering may also be obtained, when available, from: Piper Sandler & Co.,
Attention: Prospectus Department, 350 North 5th Street, Suite 1000, Minneapolis, Minnesota 55401, or by telephone at (800) 747-3924,
or by email at prospectus@psc.com; or TD Securities (USA) LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood,
New York 11717, or by email at TDManualrequest@broadridge.com.
This press release shall not constitute an offer to sell or the solicitation
of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or
sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Orchestra BioMed
Orchestra BioMed is a biomedical innovation company accelerating high-impact
technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two
flagship product candidates - AVIM Therapy and Virtue SAB - are currently undergoing pivotal clinical trials for their lead indications.
AVIM Therapy is a bioelectronic treatment for hypertension, the leading
risk factor for death worldwide, and is designed to be delivered by a pacemaker and achieve immediate, substantial and sustained reductions
in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic (NYSE: MDT), one
of the largest medical device companies in the world and the global leader in cardiac pacing therapies, for the development and commercialization
of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has two FDA Breakthrough
Device Designations. The BACKBEAT Trial evaluating AVIM Therapy in this population has completed enrollment.
Virtue SAB is a first-of-its-kind, non-coated drug delivery AngioInfusion™
balloon system designed to infuse a large liquid dose of proprietary extended-release formulation of sirolimus, SirolimusEFR™, for
the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB exceeded the published pharmacokinetics
of leading limus drug-eluting stents and demonstrated positive three-year clinical data in coronary In-Stent Restenosis in the SABRE study,
a multi-center prospective, independent core lab-adjudicated pilot clinical study of 50 patients conducted in Europe. Virtue SAB has been
granted Breakthrough Device Designation by the FDA for the treatment of coronary in-stent restenosis, coronary small vessel disease and
below-the-knee peripheral artery disease, in each case, within specified parameters. The Virtue Trial is currently enrolling patients.
Forward-Looking Statements
Certain statements included in this press release 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 regarding the Offering, including the completion
and timing of the Offering and the anticipated use of proceeds from the Offering. These statements are based on various assumptions, whether
or not identified in this press release, 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
commercial product candidates and ongoing regulation of the Company’s product 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, 2025, which was filed with the SEC on March 12, 2026, as such discussion may be updated from time to
time by subsequent filings the Company may make with the SEC, as well as the risks identified in the registration statement and the preliminary
prospectus supplement relating to the Offering.
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.
Investor Contact
Silas Newcomb
Orchestra BioMed
snewcomb@orchestrabiomed.com
Media Contact
Nina Premutico
Orchestra BioMed
npremutico@orchestrabiomed.com
