What changed in Orchestra BioMed Holdings, Inc.'s 10-K — 2022 vs 2023

Item 1. Business Our Vision Our vision is to accelerate medical innovation to patients through risk-reward-sharing partnerships with leading medical device companies. Our Company We are a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies.

Our partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products we develop. We are led by a highly accomplished, multidisciplinary management team and a board of directors with extensive experience in all phases of therapeutic device development.

Our business was formed in 2018 by assembling a pipeline of multiple late-stage clinical product candidates originally developed by our founding team. Our lead product candidate is BackBeat Cardiac Neuromodulation Therapy (“BackBeat CNT”) for the treatment of hypertension (“HTN”), the leading risk factor for death worldwide.

We have an exclusive license and collaboration agreement with Medtronic, Inc. for the development and commercialization of BackBeat CNT for the treatment of HTN in patients indicated for a cardiac pacemaker. We are also developing the Virtue Sirolimus AngioInfusion Balloon (“Virtue SAB”) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide.

We have a strategic collaboration with Terumo Medical Corporation (“Terumo”) for the development and commercialization of Virtue SAB for the treatment of coronary and peripheral artery disease.

Pursuant to the Merger Agreement, (i) HSAC2 deregistered in the Cayman Islands in accordance with the Companies Act (2022 Revision) (As Revised) of the Cayman Islands and domesticated as a Delaware corporation in accordance with Section 388 of the Delaware General Corporation Law (the “Domestication”) and (ii) Merger Sub merged with and into Legacy Orchestra, with Legacy Orchestra as the surviving company in the merger and, after giving effect to such merger, continuing as a wholly owned subsidiary of Orchestra (the “Merger” and, together with the Domestication and the other transactions contemplated by the Merger Agreement, the “Business Combination”).

As part of the Domestication, the Company’s name was changed from “Health Sciences Acquisitions Corporation 2” to “Orchestra BioMed Holdings, Inc.” BackBeat CNT, also known as Atrioventricular Interval Modulation (“AVIM”) therapy, is a bioelectronic therapy candidate designed to substantially and persistently lower blood pressure.

BackBeat CNT can be fully integrated as a firmware upgrade to standard cardiac pacemakers which, given HTN is the most common comorbidity in the pacemaker population affecting over 70% of the pacemaker-indicated patients, makes it a potentially attractive therapeutic solution for these patients.

A lthough there is no guarantee BackBeat CNT will be safe and effective, BackBeat CNT showed encouraging results in MODERATO II, a prospective, multi-center, randomized, double-blind pilot study of pacemaker patients with persistent HTN.

We estimate that the addressable annual market for pacemaker-indicated patients with HTN comprises more than 750,000 patients worldwide annually and represents a potential annual revenue opportunity of over $2 billion. We also believe BackBeat CNT may offer therapeutic benefit to select high-risk HTN patients not indicated for a pacemaker.

We estimate that this additional addressable annual market for high-risk HTN patients comprises more than 2.4 million patients worldwide and represents a potential annual revenue opportunity of more than $8 billion. 1 Table of Contents ​ On June 30, 2022, we entered into an exclusive license and collaboration agreement with Medtronic, one of the largest medical device companies in the world, for the development of BackBeat CNT for the treatment of HTN in pacemaker-indicated patients (the “Medtronic Collaboration”).

The Medtronic Collaboration provides us with development, clinical and regulatory support for the BACKBEAT pivotal study. Upon regulatory approval, if received, Medtronic will have the exclusive global rights to commercialize BackBeat CNT (AVIM therapy) for this target population.

If BackBeat CNT is approved and successfully commercialized, we will share meaningfully in the revenues generated from Medtronic’s sale of BackBeat CNT- enabled pacing systems. Medtronic has a right of first negotiation with respect to BackBeat CNT for the treatment of HTN in non-pacemaker patients.

On September 19, 2023, we announced that the FDA granted us investigational device exemption (“IDE”) approval to initiate our planned BACKBEAT ( B radyc A rdia pa C ema K er with AVIM for B lood pr E ssure tre A tmen T ) pivotal study (the “BACKBEAT pivotal study”) to treat HTN in patients indicated for a pacemaker.

On January 8, 2024, we announced that the first patient was enrolled and randomized into the BACKBEAT pivotal study in late December 2023.

For a detailed description of the BACKBEAT pivotal study, see “—BIOELECTRONIC PRODUCT CANDIDATES — BackBeat CNT (AVIM Therapy) for Hypertension and CNT-HF for Heart Failure—Clinical Results—Clinical, Regulatory and Commercialization Pathway—The BACKBEAT Global Pivotal Study.” On February 26, 2024, we announced new data showing sustained, clinically meaningful reduction in 24-hour ambulatory systolic blood pressure (aSBP) in hypertensive pacemaker patients treated with AVIM therapy for over 3 years.

Reduction in aSBP measured at 6 months from randomization and therapy activation was the primary endpoint of the MODERATO II study, a European multi-center, double-blind, randomized pilot study involving 47 subjects.

Patients randomized to AVIM therapy and antihypertension medication in that study experienced an 11.1 mmHg (p On March 6, 2024, we announced the presentation of results from a pressure-volume (“PV”) loop clinical study of AVIM therapy (also known as BackBeat CNT) in pacemaker-indicated patients with uncontrolled HTN despite the use of antihypertensive medication.

The new clinical data demonstrate the favorable hemodynamic impact of AVIM therapy as compared to standard right ventricular (RV) pacing on systolic blood pressure and overall cardiac function when delivered using both conduction system (CSP) as well as standard pacing lead locations.

AVIM therapy with pacing leads placed in standard RV (“AVIM RV”) locations, as well as in conduction system pacing (“AVIM CSP”) locations targeting the left bundle branch area (LBBA) regions, respectively, was compared to standard atrial-ventricular (“AV”) sequential pacing (DDD mode pacing or “AV Pacing”).

Overall mean results for each variable were calculated using paired measurements for each individual patient using AVIM RV, AVIM CSP and AV Pacing, respectively: ​ ● AVIM therapy generated statistically significant reductions ( p ) in systolic blood pressure (“SBP”), end diastolic volume (“EDV”), end diastolic pressure (“EDP”), and end systolic volume (“ESV”) using both AVIM RV and AVIM CSP pacing lead locations compared to AV Pacing. o SBP was reduced by 17.1 mmHg and 19.2 mmHg compared to 1.6 mmHg o EDV was reduced by 12.6 mL and 18.6 mL compared to 1.4 mL o EDP was reduced by 2.3 mmHg and 3.6 mmHg compared to an increase of 0.3 mmHg o ESV was reduced by 11.0 mL and 14.1 mL compared to an increase of 1.8 mL ● AVIM therapy drove statistically significant ( p ) reductions in stroke work (SW) without significantly reducing stroke volume (SV) compared to AV Pacing. o Stroke work (SW) was reduced by 1596 mL and 1870 mL compared to 42 mL o Stroke volume (SV) was not significantly reduced by AVIM RV, AVIM CSP or AV Pacing 2 Table of Contents ​ ● AVIM therapy drove statistically significant ( p ) reductions in total peripheral resistance (“TPR”, measured as change in effective arterial elastance or “Ea”) and no change in contractility (measured as change in end-systolic elastance or “Ees”) compared to AV Pacing. o Effective arterial elastance (“Ea”, a measure of TPR) was reduced by 0.23 mmHg/mL and 0.31 mmHg/mL compared to an increase of 0.04 mmHg/mL o Ees remained unchanged with AVIM RV, AVIM CSP and AV Pacing Virtue SAB is a proprietary drug/device combination product candidate for the treatment of artery disease that is designed to deliver a proprietary, investigational, extended-release formulation of sirolimus (“SirolimusEFR”) to the vessel wall during balloon angioplasty without the need for balloon coating or a permanent implant.

Although there is no guarantee Virtue SAB will prove to be safe and effective, Virtue SAB demonstrated promising three-year clinical data in the treatment of coronary In-Stent Restenois (“ISR”) in the prospective, multi-center SABRE Study.

Virtue SAB was granted Breakthrough Device designation by the FDA, for specific indicat ions relating to the treatment of coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee.

We estimate that these indications will represent an annual global addressable market opportunity of at least $4 billion, based on approximately 3.2 million procedures, as discussed below under “— FOCAL THERAPIES — Virtue SAB for Artery Disease and SirolimusEFR for Local Inflammation in Multiple Indications. — Targeted Unmet Needs and Market Opportunity for Virtue SAB.” On August 8, 2023, we announced that the FDA granted us investigational device exemption approval with conditions to initiate our planned Virtue ISR-US pivotal study evaluating the efficacy and safety of Virtue SAB for the treatment of patients with coronary ISR.

The conditional approval permits us to initiate enrollment of the Virtue ISR-US pivotal study following completion of clinical trial initiation activities, including clinical center Institutional Review Board approvals. We are also required to submit additional information to the FDA.

We have a strategic partnership with Terumo, a global leader in medical technology, for the development and commercialization of Virtue SAB to treat coronary artery disease (“CAD”) or peripheral artery disease (“ PAD”).

Under the terms of our partnership, it is expected that Terumo will assume financial and execution responsibility for substantially all future clinical and regulatory development, with the exception of the Virtue ISR-US pivotal study, for which we are responsible.

Terumo will also be responsible for device manufacturing, commercial sales, marketing and distribution for Virtue SAB for coronary and peripheral vascular indications globally. If Virtue SAB is successfully developed and approved, we will share meaningfully in future commercial revenues of Virtue SAB through double-digit royalties on net sales and per unit payments as the exclusive supplier of SirolimusEFR.

As previously disclosed, we have been negotiating with Terumo for mutually agreeable adjustments to our distribution agreement with Terumo (the “Terumo Agreement”) with the purpose of restructuring milestone payments as well as making other potential material modifications to that agreement, including additional financial commitments by Terumo to Orchestra and the Virtue SAB program.

We have delayed initiation of our Virtue ISR-US pivotal study until such time as we and Terumo restructure the Terumo Agreement in a manner that provides us with a satisfactory amount of additional capital, whether from milestone payments or other financial arrangements.

In addition, in light of the recent FDA approval of Boston Scientific Corporation’s AGENT™ paclitaxel-coated balloon for the treatment of coronary ISR, we and Terumo are reviewing the design for the Virtue ISR-US pivotal study and considering alternative clinical study designs with input from our clinical steering committee for Virtue SAB.

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. 3 Table of Contents ​ History of Caliber and BackBeat We were incorporated in Delaware in January 2017 and were formed to acquire operating and other assets as well as to raise capital to support further development of acquired assets.

We had limited activity in 2017. In May 2018, we concurrently completed a recapitalization and mergers with Caliber Therapeutics, Inc., a Delaware corporation that has, among other things, the rights to the Virtue SAB product candidate and BackBeat Medical, Inc., a Delaware corporation that has, among other things, the rights to the BackBeat CNT product candidate.

Caliber Therapeutics, Inc. was incorporated in Delaware in October 2005 and began development of its lead product candidate, Virtue SAB, in 2008. BackBeat Medical, Inc. was incorporated in Delaware in January 2010 and began development of its lead product candidate, BackBeat CNT, that same year.

Conversion of Caliber and BackBeat Limited Liability Companies On December 26, 2019, we completed the conversions of Caliber Therapeutics, Inc., a Delaware corporation, to Caliber Therapeutics, LLC, a Delaware limited liability company, and BackBeat Medical, Inc., a Delaware corporation, to BackBeat Medical, LLC, a Delaware limited liability company.

References in this Annual Report on Form 10-K to “Caliber” refer to Caliber Therapeutics, Inc. prior to its conversion to a limited liability company and to Caliber Therapeutics, LLC after its conversion to a limited liability company, as applicable.

References in this Annual Report on Form 10-K to “BackBeat” refer to BackBeat Medical, Inc. prior to its conversion to a limited liability company and to BackBeat Medical, LLC after its conversion to a limited liability company, as applicable.

Partnership-Enabled Business Model Our business was formed specifically to pursue a partnership-enabled business model that seeks to apply strategies typically used by the biopharmaceutical industry to the medical device market where product developers are typically challenged with the financial and execution burdens of also needing to commercialize the products they are developing in order to achieve a value inflection event for their shareholders.

Our goal is to accelerate and improve the likelihood of its product innovations reaching patients and providers worldwide by sharing the risks and rewards of developing and commercializing these product candidates with established multinational companies, such as Medtronic and Terumo.

Item 2. Properties Our headquarters are located at 150 Union Square Drive New Hope, Pennsylvania 18938, where we lease approximately 8,052 rentable square feet of office and laboratory space under a lease that terminates on September 30, 128 Table of Contents ​ 2024.

We believe that our existing facilities are adequate to meet our current needs, and that suitable additional alternative spaces will be available in the future on commercially reasonable terms.

Prior to the consummation of the Business Combination, HSAC2’s ordinary shares were listed on the Nasdaq Capital Market under the symbol “HSAQ.” Holders As of March 22, 2024, there were 595 holders of record of our common stock, which amount does not include participants of The Depository Trust Company or beneficial owners holding shares through nominee names.

Should we decide in the future to do so, as a holding company, our ability to pay dividends on our capital stock and meet other obligations depends upon the receipt of dividends or other payments from our operating subsidiaries, including Legacy Orchestra.

In addition, the ability to pay cash dividends may be restricted by the terms of debt financing arrangements, as any future debt financing arrangement likely will contain terms restricting or limiting the amount of dividends that may be declared or paid on our securities.

Securities Authorized for Issuance under Equity Compensation Plans Information about our equity compensation plans in Item 12 of Part III of this Annual Report on Form 10-K is incorporated herein by reference. ​ Recent Sales of Unregistered Securities The following sets forth information as to all of equity securities sold during the year ended December 31, 2023 which were not registered under the Securities Act: Warrants Issued to Avenue 129 Table of Contents ​ In June 2022, Legacy Orchestra entered into a loan and security agreement (the “2022 Loan and Security Agreement”) with Avenue Venture Opportunities Fund, L.P.

(“Avenue I”) and Avenue Venture Opportunities Fund II, L.P. (“Avenue II,” and, collectively with Avenue I, “Avenue”). On October 6, 2023, the 2022 Loan and Security Agreement was repaid in full and terminated.

In connection with the repayment and termination of the 2022 Loan and Security Agreement, on October 6, 2023, the Company issued two warrants to purchase an aggregate of 27,707 shares of common stock to Avenue at an exercise price of $7.67 per share.

The warrants were issued in lieu of a cash payment of $212,500 due with respect to certain fees under the 2022 Loan and Security Agreement. The Company issued these securities in a transaction not involving an underwriter and not requiring registration under Section 5 of the Securities Act in reliance on the exemption afforded by Section 4(a)(2) thereof.

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. Unless otherwise indicated or the context otherwise requires, references to “Orchestra,” “Orchestra’s,” “the Company,” “we,” “its” and “our” refer to Orchestra BioMed Holdings, Inc. and its consolidated subsidiaries. All references to years, unless otherwise noted, refer to the Company’s fiscal years, which end on December 31.

In addition to historical financial information, this discussion contains forward-looking statements based upon our current expectations that involve risks and uncertainties. Our actual results could differ materially from such forward-looking statements as a result of various factors, including those set forth under “Item 1A. Risk Factors” herein.

Pursuant to the Merger Agreement, (i) HSAC2 deregistered in the Cayman Islands in accordance with the Companies Act (2022 Revision) (As Revised) of the Cayman Islands and domesticated as a Delaware corporation in accordance with Section 388 of the Delaware General Corporation Law (the “Domestication”) and (ii) Merger Sub merged with and into Legacy Orchestra, with Legacy Orchestra as the surviving company in the merger and, after giving effect to such merger, continuing as a wholly owned subsidiary of Orchestra (the “Merger” and, together with the Domestication and the other transactions contemplated by the Merger Agreement, the “Business Combination”).

As part of the Domestication, we changed our name from “Health Sciences Acquisitions Corporation 2” to “Orchestra BioMed Holdings, Inc.” On January 27, 2023, our common stock (“Company Common Stock”) began trading on the Nasdaq Global Market under the symbol “OBIO.” For additional information, see Note 3 to the Consolidated Financial Statements.

Reverse Recapitalization The Business Combination is accounted for as a reverse recapitalization (the “Reverse Recapitalization”) in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Under this method of accounting, HSAC2 is treated as the “acquired” company and Legacy Orchestra is treated as the acquirer for financial reporting purposes.

As a result, the consolidated assets, liabilities and results of operations prior to the Reverse Recapitalization are those of Legacy Orchestra. Additionally, the shares and corresponding capital amounts and losses per share, prior to the Business Combination, have been retroactively restated based on the exchange ratio established in the Merger Agreement (the “Exchange Ratio”).

For additional information on the Business Combination and the Exchange Ratio, see Note 3 to the Consolidated Financial Statements. Overview We are a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies.

Our partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products we develop. We are led by a highly accomplished, multidisciplinary management team and a board of directors with extensive experience in all phases of therapeutic device development.

Our business was formed in 2018 by assembling a pipeline of multiple late-stage clinical product candidates originally developed by our founding team. Our lead product candidate is BackBeat Cardiac Neuromodulation Therapy (“BackBeat CNT”) for the treatment of hypertension (“HTN”), the leading risk factor for death worldwide.

We have an exclusive license and collaboration agreement with Medtronic, Inc. for the development and commercialization of BackBeat CNT for the treatment of HTN in patients indicated for a cardiac pacemaker. We are also developing the Virtue Sirolimus AngioInfusion Balloon (“Virtue SAB”) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide.

We have a strategic collaboration with Terumo 131 Table of Contents ​ Medical Corporation (“Terumo”) for the development and commercialization of Virtue SAB for the treatment of coronary and peripheral artery disease.

Since Legacy Orchestra’s inception, we have devoted the substantial majority of our resources to performing research and development and clinical activities in support of our product development and collaboration efforts.

We have funded our operations primarily through the issuance of convertible preferred stock and proceeds from the Business Combination, as well as through proceeds from the Terumo Agreement, borrowings under debt arrangements and, to a lesser extent, from product revenue from our subsidiary, FreeHold Surgical, LLC. (“FreeHold”).

We have raised a cumulative $166.8 million in gross proceeds through the issuance of convertible preferred stock, $70.0 million in gross proceeds from the Business Combination, and have received $30.0 million from the Terumo Agreement through December 31, 2023. We have incurred net losses each year since inception.

Our net losses were $49.1 million and $33.6 million for the years ended December 31, 2023 and 2022, respectively. We expect to continue to incur significant losses for the foreseeable future. As of December 31, 2023, we had an accumulated deficit of $248.9 million.

Legacy Orchestra, our wholly owned subsidiary, was incorporated in Delaware in 2017 and completed a recapitalization and mergers with Caliber Therapeutics, Inc., a Delaware corporation that has, among other things, the rights to the Virtue SAB product candidate and BackBeat Medical, Inc., a Delaware Corporation that has, among other things, the rights to the Backbeat CNT product candidate, in 2018.

Legacy Orchestra completed the conversions of Caliber Therapeutics, Inc. to Caliber Therapeutics, LLC, a Delaware limited liability company, and BackBeat Medical, Inc. to BackBeat Medical, LLC, a Delaware limited liability company, in 2019.

Recent Developments On January 8, 2024, we announced that in late December 2023 the first enrolled patient was randomized into the BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) pivotal study (the “BACKBEAT pivotal study”) of BackBeat CNT, also known as Atrioventricular Interval Modulation (“AVIM”) therapy, to treat hypertension in patients indicated for a pacemaker.

This is following the FDA granting us IDE approval, which was announced on September 19, 2023.

For a detailed description of the BACKBEAT pivotal study, see the information in under the heading “BIOELECTRONIC PRODUCT CANDIDATES – BackBeat CNT (AVIM Therapy) for Hypertension and CNT-HF for Heart Failure – Clinical Results – Clinical, Regulatory and Commercialization Pathway – The BACKBEAT Global Pivotal Study” in Item 1 (Business) of this Annual Report on Form 10-K.

On February 26, 2024, we announced new data showing sustained, clinically meaningful reductions in 24-hour ambulatory systolic blood pressure (aSBP) in hypertensive pacemaker patients treated with AVIM therapy for over 3 years.

For more information, please see “BIOELECTRONIC PRODUCT CANDIDATES – BackBeat CNT (AVIM Therapy) for Hypertension and CNT-HF for Heart Failure – Clinical Results – Chronic Clinical Studies: - the MODERATO II Long-Term Follow Up Study:” in Item 1 (Business) of this Annual Report on Form 10-K. “Our Company” in Item 1 (Business) of this Annual Report on Form 10-K.

On March 6, 2023, we announced the presentation of results from a clinical study demonstrating favorable hemodynamics effects of AVIM therapy in hypertensive pacemaker patients.

For more information, see “BIOELECTRONIC PRODUCT CANDIDATES – BackBeat CNT (AVIM Therapy) for Hypertension and CNT-HF for Heart Failure – Clinical Results – Acute Clinical Study (Prague):” in Item 1 (Business) of this Annual Report on Form 10-K.

Registration Statement The holders of an aggregate of 17,148,494 shares of common stock (not including 1,310,000 shares underlying warrants), or approximately 47.9% of our outstanding common stock as of March 22, 2024 are entitled to registration rights under the Amended and Restated Registration Rights Agreement entered into in connection with the closing of the Business Combination, and the Company expects to file on the date hereof an amendment to the registration statement 132 Table of Contents ​ that registers, among other things, the resale of those outstanding shares of common stock as well as the issuance of shares of common stock underlying warrants (the “Registration Statement”), which has the potential to significantly impact the market for our common stock.

When a large number of shares become available for sale, it can create an imbalance between supply and demand, potentially resulting in downward pressure on the market price of the stock. The increased supply of shares from the resale could outweigh the existing demand, leading to a potential decline in the market price of our common stock.

Due to the significant number of redemptions of HSAC2’s ordinary shares in connection with the Business Combination, there was a significantly lower number of HSAC2 ordinary shares that converted into shares of our common stock in connection with the Business Combination.

As a result, the shares of our common stock being registered for resale (a portion of which may not be resold until the expiration of the applicable lock-up period) are anticipated to constitute a considerable percentage of our public float.

Additionally, a significant portion of the shares of our common stock being registered for resale were originally purchased by selling securityholders pursuant to investments in Legacy Orchestra at prices considerably below the current market price of our common stock.

This discrepancy in purchase prices may have an impact on the market perception of our common stock’s value and could increase the volatility of the market price of our common stock or result in a significant decline in the public trading price of our common stock.

The registration of these shares for resale creates the possibility of a significant increase in the supply of our common stock in the market. The increased supply, coupled with the potential disparity in purchase prices, may lead to heightened selling pressure, which could negatively affect the public trading price of our common stock.

The exercise prices of our warrants, in certain circumstances, may be higher than the prevailing market price of the underlying common stock. The cash proceeds to us associated with the exercise of our warrants are contingent upon our stock price.

The value of our common stock may fluctuate and may not align with the exercise price of the warrants at any given time. If the warrants are “out of the money,” meaning the exercise price is higher than the market price of our common stock, there is a high likelihood that warrantholders may choose not to exercise their warrants.

As a result, we may not receive any proceeds from the exercise of such warrants. Components of Our Results of Operations Partnership Revenue To date, our partnership revenues have related to the Terumo Agreement described below.

In future periods, partnership revenues may also include revenues related to the Exclusive License and Collaboration Agreement, dated as of September 30, 2022, by and among, Legacy Orchestra, BackBeat Medical, LLC and Medtronic, Inc. (an affiliate of Medtronic plc) (the “Medtronic Agreement”), discussed in Note 5, Medtronic Agreement , to the Consolidated Financial Statements.

Legacy Orchestra entered into the Terumo Agreement in June 2019, and has determined that the arrangement represents a contract with a customer and is therefore in scope of ASC 606, Revenues from Contracts with Customers (“ASC 606”).

Under the Terumo Agreement, Legacy Orchestra received an upfront payment of $30.0 million in 2019 and an equity commitment of up to $5 million of which $2.5 million was invested in June 2019 as part of the Legacy Orchestra Series B-1 financing and $2.5 million was invested in June 2022 as part of the Legacy Orchestra Series D-2 financing.

Under the Terumo Agreement, we were initially eligible for certain milestone payments in the amount of $65 million from Terumo upon completion of certain minimum enrollments in clinical studies, making certain filings and submissions, and obtaining certain regulatory approvals and certifications, and are also eligible to earn royalties on future sales by Terumo based on royalty rates ranging from 10 - 15%.

Of these milestone payments, $35 million relate to achieving certain milestones by specified target achievement dates. As of the date of this Annual Report on Form 10-K, we have already passed the target achievement dates for two $5 million milestone payments, in each case, without achieving the related milestones.