Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2024 | Aug. 07, 2024 | |
Document And Entity Information Abstract | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2024 | |
Document Fiscal Year Focus | 2024 | |
Document Transition Report | false | |
Entity File Number | 001-39421 | |
Entity Registrant Name | Orchestra BioMed Holdings, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 92-2038755 | |
Entity Address, Address Line One | 150 Union Square Drive | |
Entity Address, City or Town | New Hope | |
Entity Address, State or Province | PA | |
Entity Address, Postal Zip Code | 18938 | |
City Area Code | 215 | |
Local Phone Number | 862-5797 | |
Title of 12(b) Security | Common stock, par value $0.0001 per share | |
Trading Symbol | OBIO | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 37,824,571 | |
Entity Central Index Key | 0001814114 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 23,713 | $ 30,559 |
Marketable securities | 41,468 | 56,968 |
Strategic investments, current portion | 68 | |
Accounts receivable, net | 80 | 99 |
Inventory | 70 | 146 |
Prepaid expenses and other current assets | 1,150 | 1,274 |
Total current assets | 66,481 | 89,114 |
Property and equipment, net | 1,235 | 1,279 |
Right-of-use assets | 1,331 | 1,555 |
Strategic investments, less current portion | 2,495 | 2,495 |
Deposits and other assets | 841 | 769 |
TOTAL ASSETS | 72,383 | 95,212 |
CURRENT LIABILITIES: | ||
Accounts payable | 6,273 | 2,900 |
Accrued expenses and other liabilities | 4,225 | 5,149 |
Operating lease liability, current portion | 350 | 649 |
Deferred revenue, current portion | 3,656 | 2,510 |
Total current liabilities | 14,504 | 11,208 |
Deferred revenue, less current portion | 12,652 | 14,923 |
Operating lease liability, less current portion | 1,102 | 1,038 |
TOTAL LIABILITIES | 28,258 | 27,169 |
STOCKHOLDERS' EQUITY | ||
Preferred stock, $0.0001 par value per share; 10,000,000 shares authorized; none issued or outstanding at June 30, 2024 and December 31, 2023. | ||
Common stock, $0.0001 par value per share; 340,000,000 shares authorized; 35,824,571 and 35,777,412 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively. | 4 | 4 |
Additional paid-in capital | 322,441 | 316,903 |
Accumulated other comprehensive loss | (23) | (10) |
Accumulated deficit | (278,297) | (248,854) |
TOTAL STOCKHOLDERS' EQUITY | 44,125 | 68,043 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 72,383 | $ 95,212 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parentheticals) - $ / shares | Jun. 30, 2024 | Dec. 31, 2023 |
Condensed Consolidated Balance Sheets | ||
Preference shares, par value (in Dollars per share) | $ 0.0001 | $ 0.0001 |
Preference shares, shares authorized | 10,000,000 | 10,000,000 |
Preference shares, shares issued | 0 | 0 |
Preference shares, shares outstanding | 0 | 0 |
Common stock, par value (in Dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 340,000,000 | 340,000,000 |
Common stock, shares issued | 35,824,571 | 35,777,412 |
Common stock, shares outstanding | 35,824,571 | 35,777,412 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Revenue: | ||||
Total revenue | $ 778 | $ 915 | $ 1,398 | $ 2,079 |
Expenses: | ||||
Cost of product revenues | 44 | 54 | 78 | 98 |
Research and development | 11,126 | 8,499 | 20,238 | 16,753 |
Selling, general and administrative | 6,467 | 5,318 | 12,364 | 9,729 |
Total expenses | 17,637 | 13,871 | 32,680 | 26,580 |
Loss from operations | (16,859) | (12,956) | (31,282) | (24,501) |
Other income (expense): | ||||
Interest income, net | 902 | 941 | 1,918 | 1,826 |
Loss on fair value adjustment of warrant liability | (294) | |||
Loss on fair value of strategic investments | (23) | (31) | (68) | (17) |
Other expense | (11) | |||
Total other income | 879 | 910 | 1,839 | 1,515 |
Net loss | $ (15,980) | $ (12,046) | $ (29,443) | $ (22,986) |
Net loss per share | ||||
Basic (in Dollars per share) | $ (0.45) | $ (0.35) | $ (0.82) | $ (0.74) |
Diluted (in Dollars per share) | $ (0.45) | $ (0.35) | $ (0.82) | $ (0.74) |
Weighted-average shares used in computing net loss per share, basic (in Shares) | 35,800,273 | 34,613,466 | 35,789,137 | 31,228,323 |
Weighted-average shares used in computing net loss per share, diluted (in Shares) | 35,800,273 | 34,613,466 | 35,789,137 | 31,228,323 |
Comprehensive loss | ||||
Net loss | $ (15,980) | $ (12,046) | $ (29,443) | $ (22,986) |
Unrealized loss on marketable securities | (15) | (61) | (13) | (88) |
Comprehensive loss | (15,995) | (12,107) | (29,456) | (23,074) |
Partnership revenue | ||||
Revenue: | ||||
Total revenue | 628 | 728 | 1,125 | 1,747 |
Product revenue | ||||
Revenue: | ||||
Total revenue | $ 150 | $ 187 | $ 273 | $ 332 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders Equity (Deficit) - USD ($) $ in Thousands | Previously Reported Convertible Preferred Stock | Previously Reported Common Stock | Previously Reported Additional Paid-In Capital | Previously Reported Accumulated Other Comprehensive (Loss) | Previously Reported Accumulated Deficit | Previously Reported | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive (Loss) | Accumulated Deficit | Total |
Retroactive application of reverse capitalization (Note 3) | $ (165,923) | $ 2 | $ 165,921 | $ 165,923 | |||||||
Retroactive application of reverse capitalization (Note 3) (in shares) | (35,694,179) | 17,665,636 | |||||||||
Balance at Dec. 31, 2022 | $ 165,923 | 86,353 | $ (8) | $ (199,734) | (113,389) | $ 2 | $ 252,274 | $ (8) | $ (199,734) | $ 52,534 | |
Balance (in shares) at Dec. 31, 2022 | 35,694,179 | 2,522,214 | 20,187,850 | ||||||||
Effect of Merger and recapitalization (refer to Note 3) | $ 1 | 54,301 | 54,302 | ||||||||
Effect of Merger and recapitalization (refer to Note 3) (in shares) | 11,422,741 | ||||||||||
Reclassification of Legacy Orchestra common stock warrants to stockholders equity | 2,373 | 2,373 | |||||||||
Unrealized loss on marketable securities | (27) | (27) | |||||||||
Stock-based compensation | 1,489 | 1,489 | |||||||||
Exercise of stock options | 10 | 10 | |||||||||
Exercise of stock options (in shares) | 2,325 | ||||||||||
Exercise of warrants | 11 | 11 | |||||||||
Exercise of warrants (in shares) | 128,231 | ||||||||||
Net Income (Loss) | (10,940) | (10,940) | |||||||||
Balance at Mar. 31, 2023 | $ 3 | 310,458 | (35) | (210,674) | 99,752 | ||||||
Balance (in Shares) at Mar. 31, 2023 | 31,741,147 | ||||||||||
Balance at Dec. 31, 2022 | $ 165,923 | $ 86,353 | $ (8) | $ (199,734) | $ (113,389) | $ 2 | 252,274 | (8) | (199,734) | 52,534 | |
Balance (in shares) at Dec. 31, 2022 | 35,694,179 | 2,522,214 | 20,187,850 | ||||||||
Unrealized loss on marketable securities | (88) | ||||||||||
Net Income (Loss) | (22,986) | ||||||||||
Balance at Jun. 30, 2023 | $ 4 | 312,251 | (96) | (222,720) | 89,439 | ||||||
Balance (in Shares) at Jun. 30, 2023 | 35,743,007 | ||||||||||
Balance at Mar. 31, 2023 | $ 3 | 310,458 | (35) | (210,674) | 99,752 | ||||||
Balance (in shares) at Mar. 31, 2023 | 31,741,147 | ||||||||||
Issuance of shares in settlement of earnout | $ 1 | 1 | |||||||||
Issuance of shares in settlement of earnout (in shares) | 3,999,987 | ||||||||||
Unrealized loss on marketable securities | (61) | (61) | |||||||||
Stock-based compensation | 1,707 | 1,707 | |||||||||
Forfeiture of restricted stock awards (in shares) | (45,906) | ||||||||||
Exercise of stock options | 64 | 64 | |||||||||
Exercise of stock options (in shares) | 15,500 | ||||||||||
Exercise of warrants | 22 | 22 | |||||||||
Exercise of warrants (in shares) | 32,279 | ||||||||||
Net Income (Loss) | (12,046) | (12,046) | |||||||||
Balance at Jun. 30, 2023 | $ 4 | 312,251 | (96) | (222,720) | 89,439 | ||||||
Balance (in Shares) at Jun. 30, 2023 | 35,743,007 | ||||||||||
Balance at Dec. 31, 2023 | $ 4 | 316,903 | (10) | (248,854) | 68,043 | ||||||
Balance (in shares) at Dec. 31, 2023 | 35,777,412 | ||||||||||
Unrealized loss on marketable securities | 2 | 2 | |||||||||
Stock-based compensation | 2,588 | 2,588 | |||||||||
Exercise of stock options | 18 | 18 | |||||||||
Exercise of stock options (in shares) | 7,585 | ||||||||||
Net Income (Loss) | (13,463) | (13,463) | |||||||||
Balance at Mar. 31, 2024 | $ 4 | 319,509 | (8) | (262,317) | 57,188 | ||||||
Balance (in Shares) at Mar. 31, 2024 | 35,784,997 | ||||||||||
Balance at Dec. 31, 2023 | $ 4 | 316,903 | (10) | (248,854) | 68,043 | ||||||
Balance (in shares) at Dec. 31, 2023 | 35,777,412 | ||||||||||
Unrealized loss on marketable securities | (13) | ||||||||||
Net Income (Loss) | (29,443) | ||||||||||
Balance at Jun. 30, 2024 | $ 4 | 322,441 | (23) | (278,297) | 44,125 | ||||||
Balance (in Shares) at Jun. 30, 2024 | 35,824,571 | ||||||||||
Balance at Mar. 31, 2024 | $ 4 | 319,509 | (8) | (262,317) | 57,188 | ||||||
Balance (in shares) at Mar. 31, 2024 | 35,784,997 | ||||||||||
Unrealized loss on marketable securities | (15) | (15) | |||||||||
Stock-based compensation | 2,761 | 2,761 | |||||||||
Restricted stock unit vesting (in shares) | 2,000 | ||||||||||
Exercise of stock options | 171 | 171 | |||||||||
Exercise of stock options (in shares) | 37,574 | ||||||||||
Net Income (Loss) | (15,980) | (15,980) | |||||||||
Balance at Jun. 30, 2024 | $ 4 | $ 322,441 | $ (23) | $ (278,297) | $ 44,125 | ||||||
Balance (in Shares) at Jun. 30, 2024 | 35,824,571 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (29,443) | $ (22,986) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 148 | 144 |
Stock-based compensation | 5,349 | 3,196 |
Loss on fair value adjustment of warrant liability | 294 | |
Loss on fair value of strategic investments | 68 | 17 |
Accretion and interest related to marketable securities | (914) | (2,118) |
Non-cash lease expense | 224 | 313 |
Amortization of deferred financing fees | 73 | |
Other | 11 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | 19 | (75) |
Inventory | 76 | 98 |
Prepaid expenses and other assets | 53 | (723) |
Accounts payable, accrued expenses and other liabilities | 2,449 | (1,016) |
Operating lease liabilities - current and non-current | (235) | (341) |
Deferred revenue | (1,125) | (1,747) |
Net cash used in operating activities | (23,320) | (24,871) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of property and equipment | (115) | (62) |
Sales of marketable securities | 58,788 | 64,200 |
Purchases of marketable securities | (42,388) | (99,549) |
Net cash provided by (used in) investing activities | 16,285 | (35,411) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from exercise of warrants | 23 | |
Proceeds from exercise of stock options | 189 | 74 |
Effect of merger, net of transaction costs (Note 3) | 56,810 | |
Net cash provided by financing activities | 189 | 56,907 |
Net decrease in cash and cash equivalents | (6,846) | (3,375) |
Cash and cash equivalents, beginning of the period | 30,559 | 19,784 |
Cash and cash equivalents, end of the period | $ 23,713 | 16,409 |
Cash paid during the six months ended June 30: | ||
Interest | $ 718 |
Organization and Basis of Prese
Organization and Basis of Presentation | 6 Months Ended |
Jun. 30, 2024 | |
Organization and Basis of Presentation | |
Organization and Basis of Presentation | 1. Organization and Basis of Presentation Orchestra BioMed Holdings, Inc. (collectively, with its subsidiaries, “Orchestra” or the “Company”) (formerly known as Health Sciences Acquisitions Corporation 2) 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 with leading medical device companies to drive successful global commercialization of products it develops. The Company’s lead product candidate is atrioventricular interval modulation (“AVIM”) therapy (also known as BackBeat Cardiac Neuromodulation Therapy (“BackBeat CNT”)), for the treatment of hypertension (“HTN”), a significant risk factor for death worldwide. The Company is also developing Virtue Sirolimus AngioInfusion Balloon (“Virtue SAB”) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Prior to January 26, 2023, the Company was a special purpose acquisition company formed for the purpose of entering into a merger, amalgamation, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities. On January 26, 2023 (the “Closing Date”), the Company consummated the business combination contemplated by the Agreement and Plan of Merger, dated as of July 4, 2022 (as amended by Amendment No. 1 to Agreement and Plan of Merger, dated July 21, 2022, and Amendment No. 2 to Agreement and Plan of Merger, dated November 21, 2022, the “Merger Agreement”) by and among Health Sciences Acquisitions Corporation 2, a special purpose acquisition company incorporated as a Cayman Islands exempted company in 2020 (“HSAC2”), HSAC Olympus Merger Sub, Inc., a Delaware corporation and wholly owned subsidiary of HSAC2 (“Merger Sub”), and Orchestra BioMed, Inc. (“Legacy Orchestra”). 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.” See Note 3 for additional information. Legacy Orchestra, the Company’s wholly owned subsidiary, was incorporated in Delaware in January 2017 and was formed to acquire operating and other assets as well as to raise capital conducted through private placements. In May 2018, Legacy Orchestra concurrently completed its formation mergers (the “Formation Mergers”) with Caliber Therapeutics, Inc., a Delaware corporation, BackBeat Medical, Inc., a Delaware Corporation, and FreeHold Surgical, Inc., a Delaware corporation. Legacy Orchestra completed the conversions of BackBeat Medical, Inc. to BackBeat Medical, LLC (“BackBeat”), a Delaware limited liability company, of FreeHold Surgical, Inc. to FreeHold Surgical, LLC (“FreeHold”) and of Caliber Therapeutics, Inc. to Caliber Therapeutics, LLC (“Caliber”), a Delaware limited liability company, in 2019. Caliber Caliber Therapeutics, Inc. was incorporated in Delaware in October 2005 and began development of its lead product Virtue SAB in 2008. Virtue SAB is a patented drug/device combination product candidate for the treatment of artery disease that delivers a proprietary extended release formulation of sirolimus called SirolimusEFR to the vessel wall during balloon angioplasty without any coating on the balloon surface or the need for leaving a permanent implant such as a stent in the artery. In 2019, Legacy Orchestra entered into a distribution agreement with Terumo Medical Corporation (“Terumo”) for global development and commercialization of Virtue SAB (the “Terumo Agreement”) (See Note 4). BackBeat BackBeat Medical, Inc. was incorporated in Delaware in January 2010 and began development of its lead product AVIM therapy that same year. AVIM therapy is a patented implantable cardiac stimulation-based treatment for hypertension that is designed to immediately, substantially and persistently lower blood pressure while simultaneously modulating autonomic nervous system responses that normally drive and maintain blood pressure higher. Refer to Note 5 for details regarding the Exclusive License and Collaboration Agreement, dated as of June 30, 2022, by and among, Legacy Orchestra, BackBeat and Medtronic, Inc. (an affiliate of Medtronic plc) (the “Medtronic Agreement”). FreeHold FreeHold Surgical, Inc. was incorporated in Delaware in May 2010 and began development of its hands-free, intracorporeal retractor device for minimally-invasive surgery in 2012. FreeHold is engaged in the development, sales and marketing of its retractor products that provide optimized visual and total surgeon control during laparoscopic and robotic procedures. Basis of Presentation and Liquidity The accompanying unaudited interim condensed consolidated financial statements have been prepared pursuant to the rules and regulation of the U.S. Securities and Exchange Commission (“SEC”) for interim financial reporting. These condensed statements are unaudited and, in the opinion of management, include all adjustments (consisting of normal recurring adjustments and accruals) necessary to fairly present the results of the interim periods. The condensed consolidated balance sheet at December 31, 2023 has been derived from the audited financial statements at that date. Operating results and cash flows for the six months ended June 30, 2024 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2024 or any other future period. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) have been omitted in accordance with the rules and regulations for interim reporting of the SEC. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements included in the Company’s report for the year ended December 31, 2023 together with the related notes thereto, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 27, 2024. The Company has a limited operating history and the sales and income potential of its businesses and markets are unproven. As of June 30, 2024, the Company had an accumulated deficit of $278.3 million and has experienced net losses each year since its inception. The Company expects to incur substantial operating losses in future periods and will require additional capital as it seeks to advance its products to commercialization. The Company is subject to a number of risks and uncertainties similar to those of other companies of the same size within the biomedical device industry, such as uncertainty of clinical trial outcomes, uncertainty of additional funding, and history of operating losses. The Company follows the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 205-40, Presentation of Financial Statements — Going Concern Based on the available balance of cash and cash equivalents and marketable securities as of June 30, 2024, and subsequent proceeds received (See Note 16), management has concluded that sufficient capital is available to fund its operations and meet cash requirements through the one-year period subsequent to the issuance date of these financial statements. Management may consider plans to raise capital beyond the one-year period subsequent to the issuance date of these financial statements through issuance of equity securities, debt securities, and/or additional development and commercialization partnerships for other products within the Company’s development pipeline. The source, timing and availability of any future financing will depend principally upon market conditions, and, more specifically, on the progress of the Company’s research and development programs. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2024 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Reverse Recapitalization The Business Combination is accounted for as a reverse recapitalization in accordance with U.S. GAAP (the “Reverse Recapitalization”). Under this method of accounting, HSAC2 is treated as the “acquired” company, and Legacy Orchestra is treated as the acquirer for financial reporting purposes. Accordingly, for accounting purposes, the Business Combination was treated as the equivalent of Legacy Orchestra issuing stock for the net assets of HSAC2, accompanied by a recapitalization. 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 these unaudited condensed consolidated financial statements. Emerging Growth Company and Smaller Reporting Company Status The Company is an “emerging growth company,” as defined in Section 2(a) of the Securities Act of 1933 (the “Securities Act”), as modified by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). As such, it is eligible to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, reduced disclosure obligations regarding executive compensation in its periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. Further, Section 102(b)(1) of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies (that is, those that have not had a Securities Act registration statement declared effective or do not have a class of securities registered under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) are required to comply with the new or revised financial accounting standards. The JOBS Act provides that an emerging growth company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth companies but any such election to opt out is irrevocable. The Company has elected not to opt out of such extended transition period which means that when a standard is issued or revised and it has different application dates for public or private companies, the Company, as an emerging growth company, can adopt the new or revised standard at the time private companies adopt the new or revised standard. This may make comparison of the Company’s condensed consolidated financial statements with another public company which is neither an emerging growth company nor an emerging growth company which has opted out of using the extended transition period difficult or impossible because of the potential differences in accounting standards used. The Company will remain an emerging growth company until the earliest of (1) the last day of the fiscal year following the fifth anniversary of the closing of the initial public offering of HSAC2, (2) the last day of the fiscal year in which the Company has total annual gross revenue of at least $1.235 billion, (3) the last day of the fiscal year in which the Company is deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of the common stock of the Company (“Company Common Stock”) held by non-affiliates exceeded $700.0 million as of the last business day of the second fiscal quarter of such year, or (4) the date on which the Company has issued more than $1.0 billion in non-convertible debt securities during the prior three-year period. The Company is also a “smaller reporting company” as defined in the Exchange Act. The Company may continue to be a smaller reporting company even after the Company is no longer an emerging growth company. The Company may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as (i) the market value of the Company’s voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of the Company’s second fiscal quarter, or (ii)(a) the Company’s annual revenue is less than $100.0 million during the most recently completed fiscal year and (b) the market value of the Company’s voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of the Company’s second fiscal quarter. Use of Estimates The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures in the condensed consolidated financial statements and accompanying notes. Management bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. Actual results could differ materially from those estimates. Areas where significant estimates exist include, but are not limited to, the fair value of stock-based compensation, research and development costs incurred, the fair value of the warrant liability, and the estimated costs to complete the combined performance obligation pursuant to the Terumo Agreement (Note 4). Cash and Cash Equivalents Cash and cash equivalents are held in banks or in custodial accounts with banks. Cash equivalents are defined as all liquid investments and money market funds with maturity from date of purchase of 90 days or less that are readily convertible into cash. Marketable Securities The Company accounts for its marketable securities with remaining maturities of less than one year, or where its intent is to use the investments to fund current operations or to make them available for current operations, as short-term investments. These investments represent debt investments in corporate or government securities that are designated as available-for-sale and are carried at fair value, with unrealized gains and losses reported in stockholders’ equity as accumulated other comprehensive income (loss). The disclosed fair value related to the Company’s investments is based on market prices from a variety of industry standard data providers and generally represent quoted prices for similar assets in active markets or have been derived from observable market data. Strategic Investments Management has made investments in affiliated companies and assesses whether the Company exerts significant influence over its strategic investments. The Company considers the nature and magnitude of its investment, any voting and protective rights it holds, any participation in the governance of the other company, and other relevant factors such as the presence of a collaboration or other business relationships. To date, the Company has concluded that it does not have the ability to exercise significant influence over its strategic investments. The Company’s strategic investments consist of equity investments in common stock of Motus GI Holdings, Inc. (“Motus GI”), a publicly-held company and related party, and preferred shares of Vivasure Medical Limited (“Vivasure”), a privately-held company and related party. The Company classifies strategic investments on its balance sheet as current assets if the assets are available for use for current operations, and the Company does not have a specific plan to hold the investments for a certain duration of time. The shares held of Motus GI represent equity securities with a readily determinable fair value and are required to be measured at fair value at each reporting period using readily determinable pricing available on a securities exchange, in accordance with the provisions of Accounting Standards Update (“ASU”) 2016-01, Recognition and Measurement of Financial Assets and Liabilities Fair Value of Financial Instruments The Company applies ASC 820, Fair Value Measurement advantageous market in an orderly transaction between market participants on the measurement date. The fair value hierarchy established in ASC 820 generally requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Observable inputs reflect the assumptions that market participants would use in pricing the asset or liability and are developed based on market data obtained from sources independent of the reporting entity. Unobservable inputs reflect the entity’s own assumptions based on market data and the entity’s judgments about the assumptions that market participants would use in pricing the asset or liability and are to be developed based on the best information available in the circumstances. The carrying value of the Company’s cash and cash equivalents, accounts receivable, prepaid expense, accounts payable, and accrued expenses approximate fair value because of the short-term maturity of these financial instruments. In addition, the Company records its investment in Motus GI, marketable securities, and warrant liabilities at fair value. See Note 6 for additional information regarding fair value measurements. The valuation hierarchy is composed of three levels. The classification within the valuation hierarchy is based on the lowest level of input that is significant to the fair value measurement. The levels within the valuation hierarchy are described below: Level 1 Level 2 Level 3 Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable represent amounts due from customers. The allowance for doubtful accounts is recorded for estimated losses by evaluating various factors, including relative creditworthiness of each customer, historical collections experience and aging of the receivable. As of June 30, 2024 and December 31, 2023, an allowance for doubtful accounts was not deemed necessary. Inventory Inventory is stated at the lower of standard cost (which approximates actual cost on a first-in, first-out basis) and net realizable value. Net realizable value represents the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. The Company analyzes its inventory levels and writes down inventory that has become obsolete or has a cost basis in excess of its expected net realizable value or inventory quantities in excess of expected requirements. Excess requirements are determined based on comparison of existing inventories to forecasted sales, with consideration given to inventory shelf life. Expired inventory is disposed of, and the related costs are recognized in cost of goods sold. As of June 30, 2024 and December 31, 2023, an impairment charge as a result of obsolete inventory was not deemed necessary. Research and Development Prepayments, Accruals and Related Expenses The Company incurs costs of research and development activities conducted by its third-party service providers, which include the conduct of preclinical and clinical studies. The Company is required to estimate its prepaid and accrued research and development costs at each reporting date. These estimates are made as of the reporting date of the work completed over the life of the individual study in accordance with agreements established with the Company’s service providers. The Company determines the estimates of research and development activities incurred at the end of each reporting period through discussion with internal personnel and outside service providers, as to the progress or stage of completion of trials or services, as of the end of the reporting period, pursuant to contracts with the third parties and the agreed upon fee to be paid for such services. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are accepted by the Company or the services are performed. Accruals are recorded for the amounts of services provided that have not yet been invoiced. Property and Equipment Property and equipment are stated at cost, net of accumulated depreciation and amortization. Depreciation and amortization is computed using the straight-line method over the estimated useful lives of the respective assets. Leasehold improvements are amortized over the lesser of their useful life or the remaining life of the lease. When assets are retired or otherwise disposed of, the cost and related accumulated depreciation and amortization are removed from the balance sheet and any resulting gain or loss is reflected in operations in the period realized. Maintenance and repairs are charged to operations as incurred. Asset category Depreciable life Manufacturing equipment 10 years Office equipment 3 – 7 years Research and development equipment 7 years Leases At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the terms of the arrangement. The Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset’s economic benefits. The Company determines the initial classification and measurement of its operating right-of-use (“ROU”) assets and operating lease liabilities at the lease commencement date, and thereafter if modified. The lease term includes any renewal options that the Company is reasonably assured to exercise. The Company’s policy is to not record leases with a lease term of 12 months or less on its balance sheets. The ROU asset represents the right to use the leased asset for the lease term. The lease liability represents the present value of the lease payments under the lease. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term. Lease expense for operating leases is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expense in the statements of operations. Payments due under each lease agreement include fixed and variable payments. Variable payments relate to the Company’s share of the lessor’s operating costs associated with the underlying asset and are recognized when the event on which those payments are assessed occurs. Variable payments have been excluded from the lease liability and associated right-of-use asset. The interest rate implicit in lease agreements is typically not readily determinable, and as such, the Company utilizes the incremental borrowing rate to calculate lease liabilities, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. Debt Discount and Debt Issuance Costs Debt discounts and debt issuance costs incurred in connection with the issuance of debt are capitalized and reflected as a reduction to the related debt liability. The costs are amortized to interest expense over the term of the debt using the effective-interest method. Impairment of Long-Lived Assets The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability is measured by comparing the carrying amount to the future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the projected discounted future net cash flows arising from the asset. The Company has not identified any such impairment losses to date. Warrants The Company evaluates its warrants to determine if the contracts qualify as liabilities in accordance with ASC 480-10, Distinguishing Liabilities from Equity, Derivatives and Hedging In bundled transactions, the proceeds received from any debt instruments and liability classified warrants are allocated to the warrant at fair value first, and the residual value is then allocated to the debt instrument. Upon conversion or exercise of a warrant that is subject to liability treatment, the instrument is marked to fair value at the conversion or exercise date and the fair value is reclassified to equity. Equity classified warrants are recorded within additional paid-in capital at the time of issuance at fair value as of the issuance date and are not subject to subsequent remeasurement. Revenue Recognition The Company recognizes revenue under the core principle according to ASC 606, Revenue from Contracts with Customers The Company’s revenues are currently comprised of partnership revenues from the Terumo Agreement related to the development and commercialization of Virtue SAB, and product revenue from the sale of FreeHold’s intracorporeal organ retractors. Partnership Revenues To date, the Company’s partnership revenues have related to the Terumo Agreement as further described in Note 4. In future periods, partnership revenues may also include revenues related to the Medtronic Agreement as discussed in Note 5. The Company assessed whether the Terumo Agreement fell within the scope of ASC 808, Collaborative Arrangements The promised goods or services in the Terumo Agreement include (i) license rights to the Company’s intellectual property, and (ii) research and development services. The Company also has optional additional items in the Terumo Agreement which are considered marketing offers and are accounted for as separate contracts with the customer if such option is elected by the customer, unless the option provides a material right which would not be provided without entering into the contract. Performance obligations are promised goods or services in a contract to transfer a distinct good or service to the customer. Promised goods or services are considered distinct when (i) the customer can benefit from the good or service on its own or together with other readily available resources or (ii) the promised good or service is separately identifiable from other promises in the contract. In assessing whether promised goods or services are distinct in the Terumo Agreement, the Company considered factors such as the stage of development of the underlying intellectual property, the capabilities of the customer to develop the intellectual property on their own or whether the required expertise is readily available. The Company estimates the transaction price for the Terumo Agreement performance obligations based on the amount expected to be received for transferring the promised goods or services in the contract. The consideration includes both fixed consideration and variable consideration. At the inception of the Terumo Agreement, as well as at each reporting period, the Company evaluates the amount of potential payments and the likelihood that the payments will be received. The Company utilizes either the most likely amount method or expected amount method to estimate the amount expected to be received based on which method better predicts the amount expected to be received. If it is probable that a significant revenue reversal would not occur, the variable consideration is included in the transaction price. The Terumo Agreement contains development and regulatory milestone payments. At contract inception and at each reporting period, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect partnership revenues and earnings in the period of adjustment. The Terumo Agreement also includes sales-based royalties and the license is deemed to be the predominant item to which the royalties relate. Accordingly, the Company will recognize royalty revenue when the related sales occur. To date, the Company has not recognized any royalty revenue under the arrangement. The Company has determined that intellectual property licensed to Terumo and the research and development services to be provided to support the premarket approval by the U.S. Food and Drug Administration (the “FDA”) for the in-stent restenosis (“ISR”) indication represent a combined performance obligation that is satisfied over time, and that the appropriate method of measuring progress for purposes of recognizing revenues relates to a proportional performance model that measures the proportional performance based on the costs incurred to date relative to the total costs expected to be incurred through the completion of the performance obligation. The Company evaluates the measure of progress at each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. The Company receives payments from Terumo based on billing schedules established in the contract. Such billings for milestone related events have 10-day terms from the date the milestone is achieved, royalty payments are 20-day terms after the close of each quarter, any optional services are 20 days after receipt of an invoice and any sales of the SirolimusEFR are within 30 days after receipt of the shipping invoices. Upfront payments are recorded as deferred revenue upon receipt or when due until the Company performs its obligations under these arrangements. Amounts are recorded as accounts receivable when the right to consideration is unconditional. Product Revenues Product revenues related to sales of FreeHold’s intracorporeal organ retractors are recognized at a point-in-time upon the shipment of the product to the customer, and there are no significant estimates or judgments related to estimating the transaction price. The product revenues consist of a single performance obligation, and the payment terms are typically 30 days. Product revenues are recognized solely in the United States. Stock-Based Compensation The Company applies ASC 718-10, Compensation — Stock Compensation over the subsequent period during which the recipient is required to provide service in exchange for the award (the vesting period). The cost of each award is recognized as an expense in the financial statements over the respective vesting period on a straight-line basis. Under the requirements of ASU 2018-07, the Company accounts for stock-based compensation to nonemployees under the fair value method, which requires all such compensation to be calculated based on the fair value at the measurement date (generally the grant date) and recognized in the Company’s condensed consolidated statements of operations and comprehensive loss over the requisite service period. The Company accounts for forfeitures of stock-based awards as they occur. Net Loss Per Share Basic and diluted net loss per share is calculated by dividing net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration of potential dilutive shares of common stock. Since the Company was in a loss position for the periods presented, basic net loss is the same as diluted net loss since the effects of potentially dilutive securities are antidilutive. Potentially dilutive securities include all outstanding warrants, stock options, Earnout Consideration (Note 3), unvested restricted stock awards and restricted stock units. Shares of Company Common Stock outstanding but subject to forfeiture and cancellation by the Company (e.g., the Forfeitable Shares (as defined in Note 3)) are excluded from the weighted-average number of shares until the period in which such shares are no longer subject to forfeiture. In periods in which there is net income, the Company would apply the two-class method to compute net income per share. Under this method, earnings are allocated to common stock and participating securities based on their respective rights to receive dividends, as if all undistributed earnings for the period were distributed. The two-class method does not apply in periods in which a net loss is reported. Income Taxes The Company accounts for income taxes using the asset-and-liability method in accordance with ASC 740, Income Taxes The Company follows the guidance in ASC Topic 740-10 in assessing uncertain tax positions. The standard applies to all tax positions and clarifies the recognition of tax benefits in the financial statements by providing for a two-step approach of recognition and measurement. The first step involves assessing whether the tax position is more-likely-than-not to be sustained upon examination based upon its technical merits. The second step involves measurement of the amount to be recognized. Tax positions that meet the more-likely than-not threshold are measured at the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate finalization with the taxing authority. The Company recognizes the impact of an uncertain income tax position in the financial statements if it believes that the position is more likely than not to be sustained by the relevant taxing authority. The Company will recognize interest and penalties related to tax positions in income tax expense as applicable. Deferred Offering and Merger Costs Offering and merger costs, consisting of legal, accounting, printer and filing fees were deferred to be offset against proceeds received when the Business Combination was completed. As of December 31, 2023, there were no deferred transaction costs because upon the close of the Business Combination, they were recorded against net proceeds in additional paid-in capital. For further discussion on the Business Combination, see Note 3. Defined Contribution Plan The Company has a defined retirement savings plan under Section 401(k) of the Internal Revenue Code. This plan allows eligible employees to defer a portion of their annual compensation on a pre-tax basis. Effective January 1, 2023, the Company participates in a matching safe harbor 401(k) Plan with a Company contribution of up to 3.5% of each eligible participating employee’s compensation. Safe harbor contributions vest immediately for each participant. During the three and six months ended June 30, 2024, the Company made $135,000 and $222,000, respectively, in contributions under this safe harbor 401(k) Plan. During the three and six months ended June 30, 2023, the Company made $67,000 and $181,000, respectively, in contributions under this safe harbor 401(k) Plan. Comprehensive Loss Comprehensive loss is comprised of net loss and changes in unrealized gains and losses on the Company’s available-for-sale investments. Segment Reporting Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing performance. The Company’s CODM is its Chief Executive Officer. The Company has determined it operates in one segment. New Accounting Standards In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures |
Business Combination and Recapi
Business Combination and Recapitalization | 6 Months Ended |
Jun. 30, 2024 | |
Business Combination and Recapitalization | |
Business Combination and Recapitalization | 3. Business Combination and Recapitalization On January 26, 2023, Legacy Orchestra and HSAC2 consummated the Business Combination, with Legacy Orchestra surviving as a wholly owned subsidiary of HSAC2. As part of the Business Combination, HSAC2 changed its name to Orchestra BioMed Holdings, Inc. Upon the closing of the Business Combination (the “Closing”), the Company’s certificate of incorporation provided for, among other things, a total number of authorized shares of capital stock of 350,000,000 shares, of which 340,000,000 shares were designated common stock, $0.0001 par value per share, and of which 10,000,000 shares were designated preferred stock, $0.0001 par value per share. The Business Combination is accounted for as a reverse recapitalization in accordance with 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. Accordingly, for accounting purposes, the Business Combination was treated as the equivalent of Legacy Orchestra issuing stock for the net assets of HSAC2, accompanied by a recapitalization. The net assets of HSAC2 are stated at historical cost, with no goodwill or intangible In connection with the Business Combination, HSAC2 Holdings, LLC (the “Sponsor”) agreed that 25% or 1,000,000 shares of its shares of Company Common Stock will be forfeited to the Company (the “Forfeitable Shares”) on the first business day following the fifth anniversary of the Closing unless, as to 500,000 shares, the volume-weighted average price of the Company Common Stock is greater than or equal to $15.00 per share over any 20 trading days within any 30-trading day period (the “Initial Milestone Event”), and as to the remaining 500,000 shares, the volume-weighted average price of the Company Common Stock is greater than or equal to $20.00 per share over any 20 trading days within any 30-trading day period (the “Final Milestone Event”). Further, the Sponsor and HSAC2’s other initial shareholders prior to HSAC2’s initial public offering (the “HSAC2 IPO”) agreed to subject (i) the 4,000,000 shares of Company Common Stock issued to HSAC2’s initial shareholders prior to the HSAC2 IPO (the “Insider Shares”) and (ii) the 450,000 shares of Company Common Stock purchased in a private placement simultaneously with the HSAC2 IPO (the “Private Shares”) to a lock-up for up to 12 months following the Closing, and the Sponsor forfeited 50% of its 1,500,000 warrants in HSAC2 purchased upon consummation of the HSAC2 IPO (the “Private Warrants”), comprising 750,000 Private Warrants, for no consideration, immediately prior to the Closing (the “Sponsor Forfeiture”). Pursuant to the terms of the Merger Agreement, immediately following the Sponsor Forfeiture and prior to the Closing, HSAC2 issued 750,000 warrants to purchase Company Common Stock to eleven specified employees and directors of Legacy Orchestra (the “Officer and Director Warrants”). The Officer and Director Warrants have substantially similar terms to the forfeited Private Warrants, except that 50% of the Officer and Director Warrants will become exercisable 24 months after the Closing and the remaining 50% will become exercisable 36 months after the Closing, in each case, subject to the holder’s continued employment or service with the Company or one of its subsidiaries through such date. As of the issuance date of these financial statements, 90,000 Officer and Director Warrants have been forfeited as a result of the departures of an executive officer and a director of the Company. On April 12, 2023, the Initial Milestone Event was achieved, and, as a result, 500,000 of the Forfeitable Shares are no longer subject to forfeiture. In connection with the Business Combination, existing Legacy Orchestra stockholders also had the opportunity to elect to participate in an earnout (the “Earnout”) pursuant to which each such electing stockholder (an “Earnout Participant”) may receive a portion of additional contingent consideration of up to 8,000,000 shares of Company Common Stock in the aggregate (“Earnout Consideration”). Each Earnout Participant agreed to extend their applicable lock-up period from 6 months to 12 months after the Closing, pursuant to an Earnout Election Agreement and such Earnout Participants will collectively be entitled to receive: (i) 4,000,000 shares of the Earnout Consideration, in the aggregate, in the event that, from the time beginning immediately after the Closing until the fifth anniversary of the Closing Date (the “Earnout Period”), the Initial Milestone Event occurs; and (ii) an additional 4,000,000 shares of the Earnout Consideration, in the aggregate, in the event that, during the Earnout Period, the Final Milestone Event occurs. Approximately 91% of Legacy Orchestra stockholders elected to participate in the Earnout. On April 12, 2023, the Initial Milestone Event was achieved, and each Earnout Participant was issued their Pro Rata Portion (as such term is defined in the Merger Agreement) of 4,000,000 shares of Company Common Stock, resulting in a total of 3,999,987 shares of Company Common Stock being issued (less than 4,000,000 due to rounding). Simultaneously with the execution of the Merger Agreement, HSAC2 and Legacy Orchestra entered into separate forward purchase agreements (each, as amended, a “Forward Purchase Agreement” and, together, the “Forward Purchase Agreements”) with certain funds managed by RTW Investments, LP (the “RTW Funds”) and Covidien Group S.à.r.l., an affiliate of Medtronic plc (“Medtronic” and the RTW Funds, each a “Purchasing Party”), pursuant to which each of the Purchasing Parties agreed to purchase $10 million of ordinary shares of HSAC2 (“HSAC2 Ordinary Shares”) immediately prior to the Domestication (as defined below), less the dollar amount of HSAC2 Ordinary Shares holding redemption rights that the Purchasing Party acquired and held until immediately prior to the Domestication (such HSAC2 Ordinary Shares either purchased from HSAC2 or acquired and held until immediately prior to the Domestication, the “Forward Purchase Shares”). The RTW Funds completed their purchases of HSAC2 Ordinary Shares under their Forward Purchase Agreement on or before July 22, 2022. Medtronic completed approximately $9.9 million of purchases of HSAC2 Ordinary Shares under its Forward Purchase Agreement on or before January 20, 2023. Medtronic subsequently completed $0.1 million in purchases of HSAC2 Ordinary Shares and/or Company Common Stock on or before January 30, 2023. Simultaneously with the execution of the Merger Agreement and Forward Purchase Agreements, HSAC2, Legacy Orchestra and the RTW Funds entered into a Backstop Agreement (the “Backstop Agreement”), pursuant to which the RTW Funds, jointly and severally, agreed to purchase such number of HSAC2 Ordinary Shares at a price of $10.00 per share to the extent that the amount of cash remaining in HSAC2’s working capital and trust account as of immediately prior to the closing of the Merger was less than $60 million (which calculation excludes amounts received pursuant to Medtronic’s Forward Purchase Agreement or are otherwise held in HSAC2’s trust account established pursuant to the HSAC2 IPO (the “HSAC2 Trust Account”) in respect of Medtronic’s Forward Purchase Shares, but is inclusive of amounts received pursuant to the RTW Funds’ Forward Purchase Agreement and otherwise held in the HSAC2 Trust Account in respect of the RTW Funds’ Forward Purchase Shares). Pursuant to the Backstop Agreement, the RTW Funds purchased 1,808,512 HSAC2 Ordinary Shares on January 25, 2023, immediately prior to the Domestication. Immediately prior to the closing of the Business Combination, each issued and outstanding share of Legacy Orchestra preferred stock (the “Legacy Orchestra Preferred Stock”) was canceled and converted into shares of Legacy Orchestra common stock (the “Legacy Orchestra Common Stock”) based on predetermined ratios (see Note 9). Upon the consummation of the Business Combination, each issued and outstanding share of Legacy Orchestra Common Stock was canceled and converted into the right to receive shares of Company Common Stock based upon the Exchange Ratio. The shares and corresponding capital amounts and loss per share related to Legacy Orchestra Common Stock prior to the Business Combination have been retroactively restated to reflect the Exchange Ratio. Outstanding stock options, whether vested or unvested, to purchase shares of Legacy Orchestra Common Stock (“Legacy Orchestra Options”) granted under the Orchestra BioMed, Inc. 2018 Stock Incentive Plan (“2018 Plan”) (see Note 11) converted into stock options to purchase shares of Company Common Stock upon the same terms and conditions that were in effect with respect to such stock options immediately prior to the Business Combination, after giving effect to the Exchange Ratio (the “Exchanged Options”). The following table details the number of shares of Company Common Stock issued immediately following the consummation of the Business Combination: Number of Shares Common stock of HSAC2, outstanding prior to the Business Combination 6,762,117 Less: Redemption of HSAC2 shares (1,597,888) Common stock held by former HSAC2 shareholders 5,164,229 HSAC2 sponsor shares 4,450,000 Shares issued related to Backstop Agreement 1,808,512 Total shares outstanding prior to issuance of merger consideration to Legacy Orchestra stockholders 11,422,741 Shares issued to Legacy Orchestra stockholders – Company Common Stock (1) 20,191,338 Total shares of Company Common Stock immediately after Business Combination (2) 31,614,079 (1) The number of shares of common stock issued to Legacy Orchestra equity holders was determined based on (i) 2,522,214 shares of Legacy Orchestra Common Stock outstanding immediately prior to the closing of the Business Combination converted based on the Exchange Ratio and (ii) 35,694,179 shares of Legacy Orchestra Preferred Stock outstanding immediately prior to the Closing, which pursuant to their terms converted into Legacy Orchestra Common Stock immediately prior to the Closing and then converted into Company Common Stock based on the Exchange Ratio. All fractional shares were rounded down. (2) Excludes 8,000,000 shares of Company Common Stock issued or to be issued based on satisfaction of the Initial Milestone Event and the Final Milestone Event. On April 12, 2023, the Initial Milestone Event was achieved, and each Earnout Participant was issued their Pro Rata Portion (as such term is defined in the Merger Agreement) of 4,000,000 shares of Company Common Stock, resulting in a total of 3,999,987 shares of Company Common Stock being issued (less than 4,000,000 due to rounding). The following table reconciles the elements of the Business Combination to the Company’s condensed consolidated statements of stockholders’ equity (deficit) (in thousands): Amount Cash – HSAC2’s trust (net of redemption) $ 51,915 Cash – Backstop Agreement 18,085 Gross proceeds 70,000 Less: HSAC2 and Legacy Orchestra transaction costs paid (15,698) Effect of Business Combination, net of redemptions and transaction costs $ 54,302 The $54.3 million above differs from the $56.8 million effect of the Business Combination on the condensed consolidated statements of cash flows, due to $2.5 million of transaction costs paid by Legacy Orchestra in 2022. |
Terumo Agreement
Terumo Agreement | 6 Months Ended |
Jun. 30, 2024 | |
Terumo Agreement. | |
Terumo Agreement | 4. Terumo Agreement In June 2019, Legacy Orchestra entered into the Terumo Agreement, pursuant to which Terumo secured global commercialization rights for Virtue SAB in coronary and peripheral vascular indications. Under the Terumo Agreement, Legacy Orchestra received an upfront payment of $30 million 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. The Company was initially eligible to receive up to $65 million in additional payments based on the achievement of certain development and regulatory milestones and is 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 issuance date of these financial statements, the target achievement date for three $5 million milestone payments has already passed. In addition, due to delays in the Company’s Virtue SAB program resulting from the COVID-19 pandemic, supply chain issues and unexpected changes to regulatory requirements, including increased testing and other activities related to chemistry, manufacturing, and control, increased nonclinical and good laboratory practice preclinical data requirements, including biocompatibility, as well as a requirement to repeat good laboratory practice preclinical studies already performed based on changes to source of component materials and a change in manufacturing site, the Company is unlikely to be able to complete the remaining time-based milestones by the specified target achievement dates to earn the remaining $20 million in time-based milestone payments pursuant to the Terumo Agreement. As previously disclosed, the Company and Terumo have been negotiating for mutually agreeable adjustments to 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. The Company has delayed initiation of its Virtue ISR-US pivotal study, for which it secured conditional investigational device exemption (“IDE”) approval from the FDA on August 8, 2023, until such time as the Company and Terumo restructure the Terumo Agreement in a manner that provides the Company 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, the Company and Terumo are reviewing the design for the Virtue ISR-US pivotal study and considering alternative clinical study designs with input from the Company’s clinical steering committee for Virtue SAB. If negotiations are not completed to the Company’s satisfaction or to the satisfaction of Terumo, clinical study, product development, and commercialization plans for Virtue SAB may continue to be adversely impacted. Pursuant to the terms of the Terumo Agreement, Legacy Orchestra licensed intellectual property rights to Terumo and the Company is primarily responsible for completing the development of the product in the United States to support premarket approval by the FDA for the ISR indication. These research and development services to be provided by the Company include (i) manufacturing, testing and packaging the drug required for the clinical trials, (ii) supplying Terumo with information related to the design and manufacture of the delivery device and the technology transfer needed for Terumo to ultimately commence manufacture of the delivery device, and (iii) carrying out regulatory activities related to clinical trials in the United States for the ISR indication. The Company has concluded that the license granted to Terumo is not distinct from the research and development services that will be provided to Terumo through the completion of the development of ISR indication, as Terumo cannot obtain the benefit of the license without the related research and development services. Accordingly, the Company will recognize revenues for this combined performance obligation over the estimated period of research and development services using a proportional performance model. The Company measures proportional performance based on the costs incurred relative to the total estimated costs of the research and development services. In 2019, Legacy Orchestra received a total of $32.5 million from Terumo related to the stock purchase and the revenue generating elements of the Terumo Agreement. The Company recorded the estimated fair value of the shares of $2.5 million in stockholders’ equity, as the value paid by Terumo is consistent with the value paid by other third-party stockholders in Legacy Orchestra’s offering of its Series B-1 Preferred Stock. The Company allocated the remaining $30 million to the transaction price of the Terumo Agreement. The Company considers the future potential development and regulatory milestones to be variable consideration, which are fully constrained from the transaction price as of June 30, 2024 and December 31, 2023, as the achievement of such milestone payments are uncertain and highly susceptible to factors outside of the Company’s control. The Company plans to re-evaluate the transaction price at each reporting period and as uncertain events are resolved or other changes in circumstances occur. In addition, the arrangement also includes sales-based royalties on product sales by Terumo subsequent to commercialization ranging from 10 - 15%, none of which have been recognized to date. The Company recorded the $30 million upfront payment received from Terumo in 2019 within deferred revenue. The following table presents the changes in the Company’s deferred revenue balance from the Terumo Agreement during the six months ended June 30, 2024 and 2023: Deferred Revenue – December 31, 2023 (in thousands) $ 17,433 Revenue recognized (1,125) Deferred Revenue – June 30, 2024 $ 16,308 Deferred Revenue – December 31, 2022 $ 19,539 Revenue recognized (1,747) Deferred Revenue – June 30, 2023 $ 17,792 The Company’s balance of deferred revenue contains the transaction price from the Terumo Agreement allocated to the combined license and research and development performance obligation, which was partially unsatisfied as of June 30, 2024. The Company expects to recognize approximately $3.7 million of its deferred revenue during the next twelve months 2029 As of each quarterly reporting date, the Company evaluates its estimates of the total costs expected to be incurred through the completion of the combined performance obligation and updates its estimates as necessary. For the three months ended June 30, 2024 and 2023, the expenses incurred related to the Terumo Agreement were approximately $4.0 million and $4.5 million, respectively. For the six months ended June 30, 2024 and 2023, the expenses incurred related to the Terumo Agreement were approximately $6.9 million and $8.3 million, respectively. The estimated total costs associated with the Terumo Agreement through completion increased by approximately 2.8% as of June 30, 2024, as compared to the estimates as of December 31, 2023, and increased by approximately 2.5% as of June 30, 2023, as compared to the estimates as of December 31, 2022. While the Company believes it has estimated total costs associated with the Terumo Agreement through completion, these estimates encompass a broad range of expenses over a multi-year period and, as such, are subject to periodic changes as new information becomes available. The impact of the changes in estimates resulted in a reduction of partnership revenues of $220,000 and $392,000 for the three months ended June 30, 2024 and 2023, respectively, as compared to the amounts that would have been recorded based on the previous estimates. The impact of the changes in estimates resulted in a reduction of partnership revenues of $382,000 and $303,000 for the six months ended June 30, 2024 and 2023, respectively, as compared to the amounts that would have been recorded based on the previous estimates. The impact of these changes in estimates on the net loss per share attributable to common stockholders, basic and diluted, for the three and six months ended June 30, 2024 and 2023, respectively, was an increase of $0.01. The Company will also manufacture, or have manufactured, SirolimusEFR and has exclusive rights to sell it on a per unit basis to Terumo for use in the Virtue SAB product. The Company has determined that this promise does not contain a material right as the pricing is based on standalone selling prices. Through June 30, 2024, there have been no additional amounts recognized as revenue under the Terumo Agreement other than the recognition of a portion of the upfront payment described above. |
Medtronic Agreement
Medtronic Agreement | 6 Months Ended |
Jun. 30, 2024 | |
Medtronic Agreement | |
Medtronic Agreement | 5. Medtronic Agreement In June 2022, Legacy Orchestra, BackBeat and Medtronic entered into the Medtronic Agreement for the development and commercialization of AVIM therapy for the treatment of HTN in patients indicated for a cardiac pacemaker (the “Primary Field”). Under the terms of the Medtronic Agreement, the Company will sponsor a multinational pivotal study to support regulatory approval of AVIM therapy in the Primary Field and be financially responsible for development, clinical and regulatory costs associated with this pivotal study. Medtronic is currently working with the Company to integrate AVIM therapy into its top-of-the-line, commercially available dual-chamber pacemaker system for use in the pivotal trial and will provide development, clinical and regulatory resources in support of the pivotal trial, for which the Company will reimburse Medtronic at cost. Under the terms of the Medtronic Agreement, Medtronic will have exclusive rights to commercialize AVIM therapy-enabled pacing systems globally following receipt of regulatory approval. Medtronic would be entirely responsible for global commercialization following receipt of regulatory approvals, including manufacturing, sales, marketing and distribution costs. The Company is expected to receive between $500 and $1,600 per AVIM therapy-enabled device sold based on a formula of the higher of (1) a fixed dollar amount per AVIM therapy-enabled device (amount varies materially on a country-by-country basis) or (2) a percentage of the AVIM therapy-generated sales. Procedures using the AVIM therapy-enabled pacemakers are expected to be billed under existing reimbursement codes. Medtronic has a right of first negotiation through FDA approval of AVIM therapy in the Primary Field, to expand its global rights to AVIM therapy for the treatment of HTN patients not indicated for a pacemaker. The Company assessed whether the Medtronic Agreement fell within the scope of ASC 808 and concluded that the Medtronic Agreement is a collaboration within the scope of ASC 808. In addition, the Company determined that Medtronic is a customer for a good or service that is a distinct unit of account, and therefore, the transactions in the Medtronic Agreement should be accounted for under ASC 606. The Company has concluded that the license granted to Medtronic is not distinct from the development and implementation services that will be provided to Medtronic through the completion of the development of HTN indication, as Medtronic cannot obtain the benefit of the license without the related development and implementation services. ASC 606-10-55-65 includes an exception for the recognition of revenue relating to licenses of intellectual property with sales-based or usage-based royalties. Under this exception, royalty revenue is not recorded until the subsequent sale or usage occurs, or the performance obligation has been satisfied, whichever is later. The Company concluded that the exemption applies and therefore, the royalty revenue associated with these performance obligations will be recognized as the underlying sales occur. Additionally, pursuant to the Medtronic Agreement, expenses incurred by Medtronic in connection with clinical device development and regulatory activities performed will be reimbursed by the Company. The Company will record such expenses as research and development expenses as incurred. During the three and six months ended June 30, 2024, the Company incurred approximately $1.9 million and $3.1 million, respectively, of research and development costs related to these reimbursements pursuant to the Medtronic Agreement, of which $2.8 million is included within accounts payable and accrued expenses in the Company’s June 30, 2024 condensed consolidated balance sheet. Concurrently with the close of the Medtronic Agreement, Legacy Orchestra also received a $40 million investment from Medtronic in connection with Legacy Orchestra’s Series D-2 Preferred Stock financing. The equity was purchased at a fair value consistent with the price paid by other investors at that time, and accordingly, the proceeds received were recorded as an equity investment. Through June 30, 2024, there have been no amounts recognized as revenue under the Medtronic Agreement. |
Financial Instruments and Fair
Financial Instruments and Fair Value Measurements | 6 Months Ended |
Jun. 30, 2024 | |
Financial Instruments and Fair Value Measurements | |
Financial Instruments and Fair Value Measurements | 6. Financial Instruments and Fair Value Measurements The following tables summarize the Company’s financial assets and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy: June 30, 2024 (in thousands) Level 1 Level 2 Level 3 Total Assets Money market fund (included in cash and cash equivalents) $ 12,463 $ — $ — $ 12,463 Marketable securities (Corporate and Government debt securities) — 41,468 — 41,468 Total assets $ 12,463 $ 41,468 $ — $ 53,931 December 31, 2023 (in thousands) Level 1 Level 2 Level 3 Total Assets Money market fund (included in cash and cash equivalents) $ 27,592 $ — $ — $ 27,592 Investment in Motus GI (see Note 7) 68 — — 68 Marketable securities (Corporate and Government debt securities) — 56,968 — 56,968 Total assets $ 27,660 $ 56,968 $ — $ 84,628 The Level 2 assets consist of government and corporate debt securities which are valued using market observable inputs, including the current interest rate and other characteristics for similar types of investments, whose fair value may not represent actual transactions of identical securities. There were no transfers between Levels 1, 2 or 3 for the periods presented. Prior to the closing of the Business Combination, the Company’s warrant liability was measured at fair value on a recurring basis using unobservable inputs and were classified as Level 3 inputs, and any change in fair value was recognized as change in fair value of warrant liability in the Company’s condensed consolidated statements of operations and comprehensive loss. As of the Closing Date, all Legacy Orchestra liability classified warrants were reclassified to equity. Refer to Note 10 for the valuation technique and assumptions used in estimating the fair value of the warrants and discussion on the change in classification. The following table presents a roll-forward of the aggregate fair values of the Company’s liabilities for which fair value is determined by Level 3 inputs (in thousands): Warrant Liability Balance—December 31, 2022 $ 2,089 Warrants exercised prior to the Business Combination (10) Change in fair value of warrants 294 Warrants reclassified to equity (2,373) Balance—June 30, 2023 $ — |
Marketable Securities and Strat
Marketable Securities and Strategic Investments | 6 Months Ended |
Jun. 30, 2024 | |
Marketable Securities and Strategic Investments | |
Marketable Securities and Strategic Investments | 7. Marketable Securities and Strategic Investments Marketable Securities The following is a summary of the Company’s marketable securities as of June 30, 2024 and December 31, 2023: June 30, 2024 Amortized Unrealized Unrealized Fair (in thousands) Cost Basis Gains Losses Value Corporate debt securities $ 41,490 $ 13 $ (35) $ 41,468 Total $ 41,490 $ 13 $ (35) $ 41,468 December 31, 2023 Amortized Unrealized Unrealized Fair (in thousands) Cost Basis Gains Losses Value Corporate debt securities $ 8,655 $ — $ (8) $ 8,647 Government debt securities 48,323 7 (9) 48,321 Total $ 56,978 $ 7 $ (17) $ 56,968 The Company believes it is more likely than not that its marketable securities in an unrealized loss position will be held until maturity or the recovery of the cost basis of the investment. To date, the Company has not recorded any allowance for credit losses on its investment securities. The Company determined that the unrealized losses were not attributed to credit risk but were primarily driven by the broader change in interest rates. As of June 30, 2024, $12.7 million of the Company’s marketable securities had maturities of 12 to 36 months while the remaining marketable securities had maturities of less than 12 months. For the six months ended June 30, 2024 and 2023, the Company did not recognize any realized gains or losses on its marketable securities. Strategic Investments The Company values the Motus GI investment by measuring fair value using the listed share price on the Nasdaq Capital Market on each valuation date. Aggregate losses of $23,000 and $31,000 during the three months ended June 30, 2024 and 2023, respectively, and aggregate losses of $68,000 and $17,000 during the six months ended June 30, 2024 and 2023, respectively, were recorded to adjust the strategic investments in equity securities of Motus GI to its fair value of zero at June 30, 2024 and $68,000 at December 31, 2023, which is classified as strategic investments within current assets on the accompanying condensed consolidated balance sheets. The Company’s long-term strategic investments as of June 30, 2024 represent investments made in Vivasure in 2020, 2021 and 2022 that were originally recorded at cost. There were no observable price changes or impairments identified during the six months ended June 30, 2024 and 2023 related to these investments. In May 2022, Vivasure announced a Series D private placement, in which it received a material investment from Haemonetics Corporation, a new strategic investor. In conjunction with a €30 million investment in Vivasure, Haemonetics Corporation also secured an option to acquire Vivasure based on the achievement of certain milestones. As a result, Legacy Orchestra’s existing convertible redeemable notes converted into Series D Preferred Stock of Vivasure in May 2022. The investment in the Vivasure Series D Preferred Stock represents an observable price change in an orderly transaction for an identical instrument of the same issuer, and accordingly, the Company recognized a gain on its strategic investment in Vivasure of $1.9 million in the second quarter of 2022. This amount represents a portion of the previously impaired investment balance described below. During the fourth quarter of 2019, the Company identified indicators of impairment of Vivasure strategic investments held at that time as a result of adverse changes in Vivasure’s business operations, including liquidity concerns. As a result, the Company recorded an impairment charge in the fourth quarter of 2019 of $5.8 million, which represents the cumulative impairment charges recorded on Vivasure strategic investments to date. |
Balance Sheet Components
Balance Sheet Components | 6 Months Ended |
Jun. 30, 2024 | |
Balance Sheet Components | |
Balance Sheet Components | 8. Balance Sheet Components Property and Equipment, Net Property and equipment, net consists of the following: June 30, December 31, (in thousands) 2024 2023 Equipment $ 1,783 $ 1,777 Office furniture 437 343 Leasehold improvements 159 203 Property and equipment, gross 2,379 2,323 Less accumulated depreciation and amortization (1,144) (1,044) Total Property and equipment, net $ 1,235 $ 1,279 Depreciation and amortization expense was $74,000 and $72,000 for the three months ended June 30, 2024 and 2023, respectively. Depreciation and amortization expense was $148,000 and $144,000 for the six months ended June 30, 2024 and 2023, respectively. Accrued Expenses Accrued expenses consist of the following: June 30, December 31, (in thousands) 2024 2023 Accrued compensation $ 1,772 $ 2,661 Clinical trial accruals 2,074 1,409 Other accrued expenses 379 1,079 Total accrued expenses $ 4,225 $ 5,149 |
Common and Preferred Stock
Common and Preferred Stock | 6 Months Ended |
Jun. 30, 2024 | |
Common and Preferred Stock | |
Common and Preferred Stock | 9. Common and Preferred Stock Common Stock The Company is authorized to issue up to 340,000,000 shares of Company Common Stock, par value $0.0001 per share. As discussed in Note 3, the Company has retroactively adjusted the shares issued and outstanding prior to January 26, 2023 to give effect to the Exchange Ratio to determine the number of shares of Company Common Stock into which they were converted. Preferred Stock The Company is authorized to issue 10,000,000 shares of preferred stock with a par value of $0.0001 per share. The board of directors of the Company (the “Board”) has the authority to issue preferred stock and to determine the rights, privileges, preferences, restrictions, and voting rights of those shares. As of June 30, 2024, no shares of preferred stock were outstanding. At the Market Offering and Shelf Registration Statement On May 15, 2024, the Company entered into an Open Market Sale Agreement SM |
Warrants
Warrants | 6 Months Ended |
Jun. 30, 2024 | |
Warrants | |
Warrants | 10. Warrants The Company evaluates its outstanding warrants to determine if the instruments qualify for equity or liability classification. Private Warrants Prior to the Merger, HSAC2 had outstanding 1,500,000 Private Warrants, which were issued in connection with the HSAC2 IPO to the Sponsor. Each Private Warrant entitles the holder thereof to purchase one share of Company Common Stock at a price of $11.50 per share, subject to adjustment as provided therein. The Private Warrants became exercisable 30 days after the completion of the Business Combination and will expire five years after the completion of the Business Combination. Each Private Warrant is non-redeemable and may be exercised on a cashless basis. Since these warrants are indexed to the Company’s publicly traded common stock, they are classified within equity. As described in Note 3, the Sponsor and HSAC2’s other initial shareholders prior to the HSAC2 IPO agreed to subject (i) the 4,000,000 Insider Shares and (ii) the 450,000 Private Shares to a lock-up for up to 12 months following the Closing and the Sponsor forfeited 50% of its 1,500,000 Private Warrants, comprising 750,000 Private Warrants, for no consideration, immediately prior to the Closing. Pursuant to the terms of the Merger Agreement, immediately following the Sponsor Forfeiture and prior to the Closing, HSAC2 issued 750,000 Officer and Director Warrants to eleven specified employees and directors of Legacy Orchestra. The Officer and Director Warrants have substantially similar terms to the forfeited Private Warrants, except that 50% of the Officer and Director Warrants will become exercisable 24 months after the Closing and the remaining 50% will become exercisable 36 months after the Closing, in each case, subject to the holder’s continued employment or service with the Company or one of its subsidiaries through such date. As of the issuance date of these financial statements, 90,000 Officer and Director Warrants have been forfeited as a result of the departures of an executive officer and a director of the Company. Avenue Warrants On October 6, 2023, the Company issued equity-classified warrants (the “Avenue Warrants”) to purchase 27,707 shares of Company Common Stock at an exercise price of $7.67 per share in lieu of a cash payment of approximately $212,500 to Avenue Venture Opportunities Fund, L.P. (“Avenue I”) and Avenue Venture Opportunities Fund II, L.P. (“Avenue II,” and, collectively with Avenue I, “Avenue”). The warrants were issued to settle certain fees related to the termination and repayment of the loan and security agreement with Avenue (the “2022 Loan and Security Agreement”). As of October 6, 2023, the Company valued the Avenue Warrants using the Black-Scholes option-pricing model and determined the fair value at $66,000 . The key inputs to the valuation model included the annualized volatility of 42.0% and a risk-free rate of 4.98% . Assumed Legacy Orchestra Warrants Prior to the close of the Business Combination, the majority of Legacy Orchestra’s warrants (the “Legacy Orchestra Warrants”) were required to be accounted for as liabilities as certain features within the warrant agreements contained features that were not considered “fixed for fixed” pursuant to ASC 815, and therefore, the fair value of the warrant liability was marked-to-market at each balance sheet date, with the change in fair value recorded in the Company’s condensed consolidated statements of operations and comprehensive loss within other income (expense). Upon the close of the Business Combination, all liability classified Legacy Orchestra Warrants became equity classified on that date, as the warrant agreements became “fixed for fixed.” As a result, the warrant liability was fair valued and adjusted from $2.1 million as of December 31, 2022 to $2.4 million as of January 26, 2023, and then subsequently reclassified into stockholders’ equity. In addition, Legacy Orchestra also had outstanding other equity classified warrants recorded within additional paid-in capital at the time of issuance at fair value that were not subject to subsequent remeasurement. The Company calculates the fair value of the outstanding warrant liability at each reporting date by estimating the equity value of the Company, and then utilizing option pricing models to allocate the total equity value to the shares and warrants outstanding. The inputs used in the valuation models for the Company’s warrant liability are as follows: Period from January 1, 2023 to January 26, 2023 Expected volatility 44 – 49 % Risk-free interest rate 3.60 – 4.80 % Remaining term in years 0.35 – 5.00 Exercise price of common warrants $1.08 – $30.11 Common stock price $10.63 Expected dividend yield 0 % The Company’s warrant liability related to Legacy Orchestra warrant activity rollforward is as follows, with the warrants having been converted to reflect the effect of the Merger: Common (in thousands, except share data) Warrants Amount Balance December 31, 2022 1,327,074 $ 2,089 Warrants exercised prior to the business combination (1,163) (10) Change in fair value of warrants as of January 26, 2023 — 294 Warrants reclassified to equity (1,325,911) (2,373) Balance March 31, 2023 — — Balance June 30, 2023 — $ — Private Warrants, Avenue Warrants and Assumed Legacy Orchestra Warrants The following table summarizes outstanding warrants to purchase shares of Company Common Stock as of June 30, 2024 and December 31, 2023: Number of Shares June 30, December 31, Exercise 2024 2023 Price Term Equity-classified Warrants Legacy Orchestra Warrants 507,841 507,841 $1.08 – $30.11 0.10 – 8.75 Avenue Warrants (Note 14) 27,707 27,707 $7.67 2.50 Private Warrants Held by Sponsor 750,000 750,000 $11.50 4.32 – 4.57 Private Warrants Held by Employees (Note 11) 660,000 660,000 $11.50 4.32 Total Outstanding 1,945,548 1,945,548 |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2024 | |
Stock-Based Compensation | |
Stock-Based Compensation | 11. Stock-Based Compensation As of June 30, 2024, the only equity compensation plan from which the Company may currently issue new awards is the Company’s 2023 Equity Incentive Plan (the “2023 Plan”), as more fully described below. Orchestra BioMed, Inc. 2018 Stock Incentive Plan Prior to the Merger, Legacy Orchestra maintained the 2018 Plan, under which Legacy Orchestra granted incentive stock options, non-qualified stock options and restricted stock awards to its employees and certain non-employees, including consultants, advisors and directors. The maximum aggregate shares of Legacy Orchestra Common Stock that was subject to awards and issuable under the 2018 Plan was 5.2 million shares prior to the Merger. Employees, consultants, and directors were eligible for awards granted under the 2018 Plan, which generally have a contractual life of up to 10 years and may be exercisable in cash or as otherwise determined by the Board. Vesting generally occurs over a period of not greater than three years. As described in Note 3, in connection with the Merger, each Legacy Orchestra Option that was outstanding and unexercised immediately prior to the time that the Merger became effective (the “Effective Time”) (whether vested or unvested) was assumed by the Company and converted into an option to purchase an adjusted number of shares of Company Common Stock at an adjusted exercise price per share, based on the Exchange Ratio, and will continue to be governed by substantially the same terms and conditions, including vesting, as were applicable to the former option. Each Exchanged Option is exercisable for a number of whole shares of Company Common Stock equal to the product of the number of shares of Legacy Orchestra Common Stock underlying such Legacy Orchestra Options multiplied by the Exchange Ratio, and the per share exercise price of such Exchanged Option is equal to the quotient determined by dividing the exercise price per share of the Legacy Orchestra Option by the Exchange Ratio. Following the closing of the Merger, no new awards may be made under the 2018 Plan. The Company accounted for the Exchanged Options as a modification of the existing options. Incremental compensation costs, measured as the excess, if any, of the fair value of the modified options over the fair value of the original options immediately before its terms are modified, is measured based on the fair value of the underlying shares and other pertinent factors at the modification date. The impact of the option modifications were de minimis. Orchestra BioMed Holdings, Inc. 2023 Equity Incentive Plan At the Effective Time, the Company adopted the 2023 Plan which permits the granting of incentive stock options, non-qualified options, stock appreciation rights, restricted stock, restricted stock units, performance awards and other stock-based award to employees, directors, and non-employee consultants and/or advisors. As of June 30, 2024, approximately 1.4 million shares of Company Common Stock are authorized for issuance pursuant to awards under the 2023 Plan. The pool of available shares will be automatically increased on the first day of each calendar year, beginning January 1, 2024 and ending January 1, 2032, by an amount equal to the lesser of (i) 4.8% of the outstanding shares of the Company Common Stock determined on a fully-diluted basis as of the immediately preceding December 31 and (ii) 3,036,722 shares of Common Stock, and (iii) such number of shares of Common Stock determined by the Board or the Compensation Committee prior to January 1st of a given year. In addition, any awards outstanding under the 2018 Plan upon the Closing, after adjustment for the Business Combination, remain outstanding. If any of those awards subsequently expire, terminate, or are surrendered or forfeited for any reason without issuance of shares after the closing of the Business Combination, the shares of Company Common Stock underlying those awards will automatically become available for issuance under the 2023 Plan. Total stock-based compensation related to option issuances was as follows: Three Months Ended June 30, Six Months Ended June 30, (in thousands) 2024 2023 2024 2023 Research and development $ 308 $ 330 $ 817 $ 815 Selling, general and administrative 710 631 1,191 1,369 Total stock-based compensation $ 1,018 $ 961 $ 2,008 $ 2,184 As of June 30, 2024, there was approximately $7.5 million of unrecognized stock-based compensation expense associated with the stock options noted above that is expected to be recognized over a weighted average period of approximately 2.5 years. Total stock-based compensation related to restricted stock awards and restricted stock units was as follows: Three Months Ended June 30, Six Months Ended June 30, (in thousands) 2024 2023 2024 2023 Research and development $ 392 $ — $ 739 $ — Selling, general and administrative 1,086 498 2,073 547 Total stock-based compensation $ 1,478 $ 498 $ 2,812 $ 547 As of June 30, 2024, there was approximately $11.6 million of unrecognized restricted stock-based compensation expense associated with the restricted stock noted above that is expected to be recognized over a weighted average period of approximately 2.4 years. As previously discussed in Note 3 and Note 10, pursuant to the terms of the Merger Agreement, immediately following the Sponsor Forfeiture and prior to the Closing, the Company issued 750,000 warrants to purchase Company Common Stock to eleven specified employees and directors of Legacy Orchestra. The Officer and Director Warrants have substantially similar terms to the forfeited Private Warrants, except that 50% of the Officer and Director Warrants will become exercisable 24 months after the Closing and the remaining 50% will become exercisable 36 months after the Closing. The estimated grant-date fair value of these warrant awards issued concurrent with the close of the Business Combination was calculated using the Black-Scholes option pricing model. Assumptions used were an expected term (in years) of 5.00, expected volatility of 50%, risk-free interest rate of 3.54%, expected dividend yield of 0%, and fair value of common stock of $10.63. During the year ended December 31, 2023, 90,000 of Officer and Director Warrants were forfeited resulting in 660,000 Officer and Director Warrants remaining outstanding at December 31, 2023. There were no forfeitures of Officer and Director Warrants during the three and six months ended June 30, 2024. Total stock-based compensation related to warrants was as follows: Three Months Ended June 30, Six Months Ended June 30, (in thousands) 2024 2023 2024 2023 Research and development $ 121 $ 120 $ 241 $ 207 Selling, general and administrative 144 128 288 258 Total stock-based compensation $ 265 $ 248 $ 529 $ 465 As of June 30, 2024, there was approximately $1.7 million of unrecognized stock-based compensation expense associated with the warrants noted above that is expected to be recognized over a weighted average period of approximately 1.6 Stock Option Activity The following table summarizes the stock option activity of the Company under the 2018 Plan and the 2023 Plan: Weighted Weighted Aggregate Shares Average Average Intrinsic Underlying Exercise Remaining Value Options Price Term (years) (in thousands) Outstanding at January 1, 2024 4,438,868 $ 7.72 7.70 $ 8,186 Granted 877,298 5.29 — — Exercised (45,159) 4.19 — — Forfeited/canceled (106,045) 10.00 — — Outstanding June 30, 2024 5,164,962 $ 7.29 7.69 $ 8,329 Exercisable at June 30, 2024 2,954,166 $ 7.35 6.63 $ 5,130 The weighted average grant-date fair value of stock options granted during the six months ended June 30, 2024 and 2023 was $3.56 and $4.99 per share, respectively. The following table summarizes the restricted stock awards and restricted stock units activity of the Company under the Plan: Restricted Stock Weighted Average Awards/Units Grant Date Fair Outstanding Value Outstanding January 1, 2024 1,701,208 $ 7.39 Granted 796,880 5.12 Vested (22,302) 9.19 Forfeited/canceled — — Outstanding June 30, 2024 2,475,786 $ 6.68 No performance-based stock awards were granted in the six months ended June 30, 2024. Determination of Stock Option Awards Fair Value The estimated grant-date fair value of all the Company’s option awards was calculated using the Black-Scholes option pricing model, based on the following weighted average assumptions: Six Months Ended June 30, 2024 2023 Expected term (in years) 6.15 6.00 Expected volatility 71 % 50 % Risk-free interest rate 4.44 % 3.60 % Expected dividend yield 0 % 0 % Fair value of common stock $ 5.29 $ 9.63 The fair value of each stock option grant was determined by the Company using the methods and assumptions discussed below. Each of these inputs is subjective and generally requires significant judgment and estimation by management. Expected Term Expected Volatility Risk-Free Interest Rate Expected Dividend Yield Fair Value of Common Stock Valuation of Privately-Held-Company Equity Securities Issued as Compensation |
Leases
Leases | 6 Months Ended |
Jun. 30, 2024 | |
Leases | |
Leases | 12. Leases Office Lease In January 2019, Legacy Orchestra entered into an additional addendum to the lease agreement for office space in New Hope, PA originally entered into in December 2009 (as amended, the “New Hope Lease”). The New Hope Lease covers 8,052 square feet and will expire in September 2024. Monthly fees will be between $9,000 and $19,000 for the period from commencement through expiration. In November 2019, Legacy Orchestra entered into a new lease agreement for approximately 5,200 square feet of office space in New York, NY. In November 2022, the Company entered into an amendment for this lease which increased the office space square footage to approximately 7,800 and amended the expiration to April 2028. Monthly fees will be between $28,000 and $40,000 for the period from commencement through expiration. In January 2020, Legacy Orchestra entered into an agreement for the use of portions of the office space of Motus GI, a related party, in Fort Lauderdale, Florida. The agreement will expire in September 2024. The monthly fee commenced on the month following the date of agreement. Monthly fees will be between $12,000 and $17,000 for the period from commencement through expiration. In May 2022, Legacy Orchestra amended the agreement with Motus GI for a larger portion of the office space and extended the expiration date to November 2024. Monthly fees will be between $7,000 and $23,000 for the period from commencement of the amendment to expiration. The amount paid is estimated to be proportionate to the percentage of space used by the Company applied to the monthly rent obligated to be paid by Motus GI to their landlord. Operating cash flow supplemental information for the six months ended June 30, 2024: Cash paid for amounts included in the present value of operating lease liabilities was $454,000 during the six months ended June 30, 2024 compared to $410,000 during the six months ended June 30, 2023. As of June 30, 2024: Weighted average remaining lease term – operating leases, in years 3.52 Weighted average discount rate – operating leases 9.44 % Operating Leases Rent/lease expense for office and lab space was approximately $224,000 and $209,000 for the three months ended June 30, 2024 and 2023, respectively. Rent/lease expense for office and lab space was approximately $443,000 and $417,000 for the six months ended June 30, 2024 and 2023, respectively. The table below shows the future minimum rental payments, exclusive of taxes, insurance, and other costs, under the leases as of June 30, 2024: Operating Leases Year ending December 31: (in thousands) 2024 (remaining six months) $ 301 2025 339 2026 464 2027 476 2028 159 Thereafter — Total future minimum lease payments $ 1,739 Imputed interest (287) Total liability $ 1,452 |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2024 | |
Related Party Transactions | |
Related Party Transactions | 13. Related Party Transactions In addition to transactions and balances related to cash and stock-based compensation to officers and directors, the Company had the following transactions and balances with related parties during the year ended December 31, 2023 and the six months ended June 30, 2024: Motus GI Investments On September 12, 2023, Motus GI, a related party, and the Company entered into an agreement to terminate the rights of previously held royalty certificates in exchange for 701,522 additional shares of Motus GI common stock resulting in a gain of $349,000 (Note 7). |
Debt Financing
Debt Financing | 6 Months Ended |
Jun. 30, 2024 | |
Debt Financing | |
Debt Financing | 14. Debt Financing In June 2022, Legacy Orchestra entered into the 2022 Loan and Security Agreement. The terms of the 2022 Loan and Security Agreement included a term loan of up to $20 million available in two tranches with the first tranche of $10 million that was drawn at closing in June of 2022, and a second tranche of $10 million was available at closing of the Legacy Orchestra Series D-2 Preferred Stock financing which was not drawn. Additionally, the Company may have had access to a third tranche of $30 million subject to certain financing milestones. The term loan was scheduled to mature on June 1, 2026. In addition, the lender had the right, at its discretion, but not the obligation, to convert any portion of the outstanding principal amount of the loans up to $5 million into shares of Company Common Stock at a price per share equal to $12.00 (the “Conversion Option”), subject to adjustment; provided, however, the Conversion Option could not be exercised by lender during the six Pursuant to the terms of the 2022 Loan and Security Agreement, Legacy Orchestra issued the Avenue Warrants that will be exercisable for 100,000 shares of Company Common Stock, and the estimated fair value of the warrants of $178,000 was recorded as debt discount on the date of issuance and was being amortized to interest expense over the term of the 2022 Loan and Security Agreement. In addition, other financing costs totaling $405,000 were also recorded as debt discount and were being amortized to interest expense over the term of the facility. The term loan accrued interest at a floating per annum rate equal to the Wall Street Journal prime rate plus 6.45%. The repayment terms of the loan included monthly payments over a 4-year 2-year Concurrent with the closing of the 2022 Loan and Security Agreement, Legacy Orchestra terminated and repaid an existing 2019 Loan and Security Agreement with Silicon Valley Bank (the “2019 Loan and Security Agreement”), which resulted in a loss on extinguishment of $682,000. Pursuant to the terms of the 2019 Loan and Security Agreement, Legacy Orchestra issued Silicon Valley Bank a warrant that, to the extent Legacy Orchestra made draws on the 2019 Loan and Security Agreement, was exercisable for a number of shares of Legacy Orchestra Common Stock equal to 2% of the amount drawn divided by the exercise price of $1.33 per share of Legacy Orchestra Common Stock. As a result of the draw in December of 2020, Legacy Orchestra issued 150,000 Legacy Orchestra Common Stock warrants to Silicon Valley Bank, and the estimated fair value of the warrants of $544,000 was recorded as debt discount on the date of issuance and was being amortized to interest expense over the term of the credit facility. These warrants have been exercised and are no longer outstanding. The 2019 Loan and Security Agreement accrued interest at a floating per annum rate equal to the greater of (i) the Wall Street Journal prime rate plus 1.00% or (ii) 6.25%. In addition, there was a final payment equal to 8.25% of the original aggregate principal amount which accrued over the term of the loan using the effective-interest method. Total interest expense recorded on these facilities during the three and six months ended June 30, 2023 was approximately $457,000 and $897,000, respectively, while there was no interest expense for the three and six months ended June 30, 2024. On October 6, 2023, the Company terminated and repaid the 2022 Loan and Security Agreement in an aggregate amount of $10.9 million (the “Payoff Amount”), which resulted in a loss on extinguishment of approximately $1.2 million. The Payoff Amount includes $10 million of principal and approximately $849,000 of net interest, prepayment fees, and legal fees. The Company issued warrants to purchase 27,707 shares of Company Common Stock at an exercise price of $7.67 in lieu of a cash payment of approximately $212,500 |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2024 | |
Net Loss Per Share | |
Net Loss Per Share | 15. Net Loss Per Share Basic net loss per share of Company Common Stock is computed by dividing net loss by the weighted-average number of shares of Company Common Stock. Shares of Company Common Stock outstanding but subject to forfeiture and cancellation by the Company (e.g., the Forfeitable Shares – see Note 3) are excluded from the weighted-average number of shares until the period in which such shares are no longer subject to forfeiture. As discussed in Note 3, in connection with the Business Combination, existing Legacy Orchestra stockholders had the opportunity to elect to participate in the Earnout pursuant to which each such Earnout Participant may receive a portion of additional contingent consideration of up to 8,000,000 shares of Earnout Consideration. On April 12, 2023, the Initial Milestone Event was achieved, and each Earnout Participant was issued their Pro Rata Portion (as such term is defined in the Merger Agreement) of 4,000,000 shares of Company Common Stock, resulting in a total of 3,999,987 shares of Company Common Stock being issued (less than 4,000,000 due to rounding). Additionally, 500,000 of the Forfeitable Shares are no longer subject to forfeiture as a result of the Initial Milestone Event. Diluted net loss per share of Company Common Stock includes the effect, if any, from the potential exercise or conversion of securities, such as stock options, Legacy Orchestra Warrants and Private Warrants, and Forfeitable Shares and Earnout Consideration, which would result in the issuance of incremental shares of Company Common Stock, unless their effect would be anti-dilutive. The following outstanding potentially dilutive securities have been excluded from the calculation of diluted net loss per share for the three and six months ended June 30, 2024 and June 30, 2023, as their effect is anti-dilutive: Three and Six Months Ended June 30, 2024 2023 Stock options 5,164,962 3,821,922 Company common stock warrants 1,945,548 1,966,808 Unvested restricted stock awards 2,475,786 49,237 Conversion option — 416,667 Forfeitable shares 500,000 500,000 Earnout consideration 4,000,000 4,000,000 Total 14,086,296 10,754,634 |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2024 | |
Subsequent Events | |
Subsequent Events | 16. Subsequent Events On July 11, 2024, the Company sold 2,000,000 shares of Company Common Stock under the Sale Agreement resulting in aggregate gross proceeds to the Company of approximately $15.5 million and net proceeds to the Company of approximately $15.0 million. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pay vs Performance Disclosure | ||||||
Net Income (Loss) | $ (15,980) | $ (13,463) | $ (12,046) | $ (10,940) | $ (29,443) | $ (22,986) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Jun. 30, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Summary of Significant Accounting Policies | |
Reverse Recapitalization | Reverse Recapitalization The Business Combination is accounted for as a reverse recapitalization in accordance with U.S. GAAP (the “Reverse Recapitalization”). Under this method of accounting, HSAC2 is treated as the “acquired” company, and Legacy Orchestra is treated as the acquirer for financial reporting purposes. Accordingly, for accounting purposes, the Business Combination was treated as the equivalent of Legacy Orchestra issuing stock for the net assets of HSAC2, accompanied by a recapitalization. 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 these unaudited condensed consolidated financial statements. |
Emerging Growth Company and Smaller Reporting Company Status | Emerging Growth Company and Smaller Reporting Company Status The Company is an “emerging growth company,” as defined in Section 2(a) of the Securities Act of 1933 (the “Securities Act”), as modified by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). As such, it is eligible to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, reduced disclosure obligations regarding executive compensation in its periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. Further, Section 102(b)(1) of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies (that is, those that have not had a Securities Act registration statement declared effective or do not have a class of securities registered under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) are required to comply with the new or revised financial accounting standards. The JOBS Act provides that an emerging growth company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth companies but any such election to opt out is irrevocable. The Company has elected not to opt out of such extended transition period which means that when a standard is issued or revised and it has different application dates for public or private companies, the Company, as an emerging growth company, can adopt the new or revised standard at the time private companies adopt the new or revised standard. This may make comparison of the Company’s condensed consolidated financial statements with another public company which is neither an emerging growth company nor an emerging growth company which has opted out of using the extended transition period difficult or impossible because of the potential differences in accounting standards used. The Company will remain an emerging growth company until the earliest of (1) the last day of the fiscal year following the fifth anniversary of the closing of the initial public offering of HSAC2, (2) the last day of the fiscal year in which the Company has total annual gross revenue of at least $1.235 billion, (3) the last day of the fiscal year in which the Company is deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of the common stock of the Company (“Company Common Stock”) held by non-affiliates exceeded $700.0 million as of the last business day of the second fiscal quarter of such year, or (4) the date on which the Company has issued more than $1.0 billion in non-convertible debt securities during the prior three-year period. The Company is also a “smaller reporting company” as defined in the Exchange Act. The Company may continue to be a smaller reporting company even after the Company is no longer an emerging growth company. The Company may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as (i) the market value of the Company’s voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of the Company’s second fiscal quarter, or (ii)(a) the Company’s annual revenue is less than $100.0 million during the most recently completed fiscal year and (b) the market value of the Company’s voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of the Company’s second fiscal quarter. |
Use of Estimates | Use of Estimates The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures in the condensed consolidated financial statements and accompanying notes. Management bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. Actual results could differ materially from those estimates. Areas where significant estimates exist include, but are not limited to, the fair value of stock-based compensation, research and development costs incurred, the fair value of the warrant liability, and the estimated costs to complete the combined performance obligation pursuant to the Terumo Agreement (Note 4). |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents are held in banks or in custodial accounts with banks. Cash equivalents are defined as all liquid investments and money market funds with maturity from date of purchase of 90 days or less that are readily convertible into cash. |
Marketable Securities | Marketable Securities The Company accounts for its marketable securities with remaining maturities of less than one year, or where its intent is to use the investments to fund current operations or to make them available for current operations, as short-term investments. These investments represent debt investments in corporate or government securities that are designated as available-for-sale and are carried at fair value, with unrealized gains and losses reported in stockholders’ equity as accumulated other comprehensive income (loss). The disclosed fair value related to the Company’s investments is based on market prices from a variety of industry standard data providers and generally represent quoted prices for similar assets in active markets or have been derived from observable market data. |
Strategic Investments | Strategic Investments Management has made investments in affiliated companies and assesses whether the Company exerts significant influence over its strategic investments. The Company considers the nature and magnitude of its investment, any voting and protective rights it holds, any participation in the governance of the other company, and other relevant factors such as the presence of a collaboration or other business relationships. To date, the Company has concluded that it does not have the ability to exercise significant influence over its strategic investments. The Company’s strategic investments consist of equity investments in common stock of Motus GI Holdings, Inc. (“Motus GI”), a publicly-held company and related party, and preferred shares of Vivasure Medical Limited (“Vivasure”), a privately-held company and related party. The Company classifies strategic investments on its balance sheet as current assets if the assets are available for use for current operations, and the Company does not have a specific plan to hold the investments for a certain duration of time. The shares held of Motus GI represent equity securities with a readily determinable fair value and are required to be measured at fair value at each reporting period using readily determinable pricing available on a securities exchange, in accordance with the provisions of Accounting Standards Update (“ASU”) 2016-01, Recognition and Measurement of Financial Assets and Liabilities |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company applies ASC 820, Fair Value Measurement advantageous market in an orderly transaction between market participants on the measurement date. The fair value hierarchy established in ASC 820 generally requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Observable inputs reflect the assumptions that market participants would use in pricing the asset or liability and are developed based on market data obtained from sources independent of the reporting entity. Unobservable inputs reflect the entity’s own assumptions based on market data and the entity’s judgments about the assumptions that market participants would use in pricing the asset or liability and are to be developed based on the best information available in the circumstances. The carrying value of the Company’s cash and cash equivalents, accounts receivable, prepaid expense, accounts payable, and accrued expenses approximate fair value because of the short-term maturity of these financial instruments. In addition, the Company records its investment in Motus GI, marketable securities, and warrant liabilities at fair value. See Note 6 for additional information regarding fair value measurements. The valuation hierarchy is composed of three levels. The classification within the valuation hierarchy is based on the lowest level of input that is significant to the fair value measurement. The levels within the valuation hierarchy are described below: Level 1 Level 2 Level 3 |
Accounts Receivable and Allowance for Doubtful Accounts | Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable represent amounts due from customers. The allowance for doubtful accounts is recorded for estimated losses by evaluating various factors, including relative creditworthiness of each customer, historical collections experience and aging of the receivable. As of June 30, 2024 and December 31, 2023, an allowance for doubtful accounts was not deemed necessary. |
Inventory | Inventory Inventory is stated at the lower of standard cost (which approximates actual cost on a first-in, first-out basis) and net realizable value. Net realizable value represents the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. The Company analyzes its inventory levels and writes down inventory that has become obsolete or has a cost basis in excess of its expected net realizable value or inventory quantities in excess of expected requirements. Excess requirements are determined based on comparison of existing inventories to forecasted sales, with consideration given to inventory shelf life. Expired inventory is disposed of, and the related costs are recognized in cost of goods sold. As of June 30, 2024 and December 31, 2023, an impairment charge as a result of obsolete inventory was not deemed necessary. |
Research and Development Prepayments, Accruals and Related Expenses | Research and Development Prepayments, Accruals and Related Expenses The Company incurs costs of research and development activities conducted by its third-party service providers, which include the conduct of preclinical and clinical studies. The Company is required to estimate its prepaid and accrued research and development costs at each reporting date. These estimates are made as of the reporting date of the work completed over the life of the individual study in accordance with agreements established with the Company’s service providers. The Company determines the estimates of research and development activities incurred at the end of each reporting period through discussion with internal personnel and outside service providers, as to the progress or stage of completion of trials or services, as of the end of the reporting period, pursuant to contracts with the third parties and the agreed upon fee to be paid for such services. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are accepted by the Company or the services are performed. Accruals are recorded for the amounts of services provided that have not yet been invoiced. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost, net of accumulated depreciation and amortization. Depreciation and amortization is computed using the straight-line method over the estimated useful lives of the respective assets. Leasehold improvements are amortized over the lesser of their useful life or the remaining life of the lease. When assets are retired or otherwise disposed of, the cost and related accumulated depreciation and amortization are removed from the balance sheet and any resulting gain or loss is reflected in operations in the period realized. Maintenance and repairs are charged to operations as incurred. Asset category Depreciable life Manufacturing equipment 10 years Office equipment 3 – 7 years Research and development equipment 7 years |
Leases | Leases At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the terms of the arrangement. The Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset’s economic benefits. The Company determines the initial classification and measurement of its operating right-of-use (“ROU”) assets and operating lease liabilities at the lease commencement date, and thereafter if modified. The lease term includes any renewal options that the Company is reasonably assured to exercise. The Company’s policy is to not record leases with a lease term of 12 months or less on its balance sheets. The ROU asset represents the right to use the leased asset for the lease term. The lease liability represents the present value of the lease payments under the lease. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term. Lease expense for operating leases is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expense in the statements of operations. Payments due under each lease agreement include fixed and variable payments. Variable payments relate to the Company’s share of the lessor’s operating costs associated with the underlying asset and are recognized when the event on which those payments are assessed occurs. Variable payments have been excluded from the lease liability and associated right-of-use asset. The interest rate implicit in lease agreements is typically not readily determinable, and as such, the Company utilizes the incremental borrowing rate to calculate lease liabilities, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. |
Debt Discount and Debt Issuance Costs | Debt Discount and Debt Issuance Costs Debt discounts and debt issuance costs incurred in connection with the issuance of debt are capitalized and reflected as a reduction to the related debt liability. The costs are amortized to interest expense over the term of the debt using the effective-interest method. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability is measured by comparing the carrying amount to the future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the projected discounted future net cash flows arising from the asset. The Company has not identified any such impairment losses to date. |
Warrants | Warrants The Company evaluates its warrants to determine if the contracts qualify as liabilities in accordance with ASC 480-10, Distinguishing Liabilities from Equity, Derivatives and Hedging In bundled transactions, the proceeds received from any debt instruments and liability classified warrants are allocated to the warrant at fair value first, and the residual value is then allocated to the debt instrument. Upon conversion or exercise of a warrant that is subject to liability treatment, the instrument is marked to fair value at the conversion or exercise date and the fair value is reclassified to equity. Equity classified warrants are recorded within additional paid-in capital at the time of issuance at fair value as of the issuance date and are not subject to subsequent remeasurement. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue under the core principle according to ASC 606, Revenue from Contracts with Customers The Company’s revenues are currently comprised of partnership revenues from the Terumo Agreement related to the development and commercialization of Virtue SAB, and product revenue from the sale of FreeHold’s intracorporeal organ retractors. |
Partnership Revenues | Partnership Revenues To date, the Company’s partnership revenues have related to the Terumo Agreement as further described in Note 4. In future periods, partnership revenues may also include revenues related to the Medtronic Agreement as discussed in Note 5. The Company assessed whether the Terumo Agreement fell within the scope of ASC 808, Collaborative Arrangements The promised goods or services in the Terumo Agreement include (i) license rights to the Company’s intellectual property, and (ii) research and development services. The Company also has optional additional items in the Terumo Agreement which are considered marketing offers and are accounted for as separate contracts with the customer if such option is elected by the customer, unless the option provides a material right which would not be provided without entering into the contract. Performance obligations are promised goods or services in a contract to transfer a distinct good or service to the customer. Promised goods or services are considered distinct when (i) the customer can benefit from the good or service on its own or together with other readily available resources or (ii) the promised good or service is separately identifiable from other promises in the contract. In assessing whether promised goods or services are distinct in the Terumo Agreement, the Company considered factors such as the stage of development of the underlying intellectual property, the capabilities of the customer to develop the intellectual property on their own or whether the required expertise is readily available. The Company estimates the transaction price for the Terumo Agreement performance obligations based on the amount expected to be received for transferring the promised goods or services in the contract. The consideration includes both fixed consideration and variable consideration. At the inception of the Terumo Agreement, as well as at each reporting period, the Company evaluates the amount of potential payments and the likelihood that the payments will be received. The Company utilizes either the most likely amount method or expected amount method to estimate the amount expected to be received based on which method better predicts the amount expected to be received. If it is probable that a significant revenue reversal would not occur, the variable consideration is included in the transaction price. The Terumo Agreement contains development and regulatory milestone payments. At contract inception and at each reporting period, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect partnership revenues and earnings in the period of adjustment. The Terumo Agreement also includes sales-based royalties and the license is deemed to be the predominant item to which the royalties relate. Accordingly, the Company will recognize royalty revenue when the related sales occur. To date, the Company has not recognized any royalty revenue under the arrangement. The Company has determined that intellectual property licensed to Terumo and the research and development services to be provided to support the premarket approval by the U.S. Food and Drug Administration (the “FDA”) for the in-stent restenosis (“ISR”) indication represent a combined performance obligation that is satisfied over time, and that the appropriate method of measuring progress for purposes of recognizing revenues relates to a proportional performance model that measures the proportional performance based on the costs incurred to date relative to the total costs expected to be incurred through the completion of the performance obligation. The Company evaluates the measure of progress at each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. The Company receives payments from Terumo based on billing schedules established in the contract. Such billings for milestone related events have 10-day terms from the date the milestone is achieved, royalty payments are 20-day terms after the close of each quarter, any optional services are 20 days after receipt of an invoice and any sales of the SirolimusEFR are within 30 days after receipt of the shipping invoices. Upfront payments are recorded as deferred revenue upon receipt or when due until the Company performs its obligations under these arrangements. Amounts are recorded as accounts receivable when the right to consideration is unconditional. |
Product Revenues | Product Revenues Product revenues related to sales of FreeHold’s intracorporeal organ retractors are recognized at a point-in-time upon the shipment of the product to the customer, and there are no significant estimates or judgments related to estimating the transaction price. The product revenues consist of a single performance obligation, and the payment terms are typically 30 days. Product revenues are recognized solely in the United States. |
Stock-Based Compensation | Stock-Based Compensation The Company applies ASC 718-10, Compensation — Stock Compensation over the subsequent period during which the recipient is required to provide service in exchange for the award (the vesting period). The cost of each award is recognized as an expense in the financial statements over the respective vesting period on a straight-line basis. Under the requirements of ASU 2018-07, the Company accounts for stock-based compensation to nonemployees under the fair value method, which requires all such compensation to be calculated based on the fair value at the measurement date (generally the grant date) and recognized in the Company’s condensed consolidated statements of operations and comprehensive loss over the requisite service period. The Company accounts for forfeitures of stock-based awards as they occur. |
Net Loss Per Share | Net Loss Per Share Basic and diluted net loss per share is calculated by dividing net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration of potential dilutive shares of common stock. Since the Company was in a loss position for the periods presented, basic net loss is the same as diluted net loss since the effects of potentially dilutive securities are antidilutive. Potentially dilutive securities include all outstanding warrants, stock options, Earnout Consideration (Note 3), unvested restricted stock awards and restricted stock units. Shares of Company Common Stock outstanding but subject to forfeiture and cancellation by the Company (e.g., the Forfeitable Shares (as defined in Note 3)) are excluded from the weighted-average number of shares until the period in which such shares are no longer subject to forfeiture. In periods in which there is net income, the Company would apply the two-class method to compute net income per share. Under this method, earnings are allocated to common stock and participating securities based on their respective rights to receive dividends, as if all undistributed earnings for the period were distributed. The two-class method does not apply in periods in which a net loss is reported. |
Income Taxes | Income Taxes The Company accounts for income taxes using the asset-and-liability method in accordance with ASC 740, Income Taxes The Company follows the guidance in ASC Topic 740-10 in assessing uncertain tax positions. The standard applies to all tax positions and clarifies the recognition of tax benefits in the financial statements by providing for a two-step approach of recognition and measurement. The first step involves assessing whether the tax position is more-likely-than-not to be sustained upon examination based upon its technical merits. The second step involves measurement of the amount to be recognized. Tax positions that meet the more-likely than-not threshold are measured at the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate finalization with the taxing authority. The Company recognizes the impact of an uncertain income tax position in the financial statements if it believes that the position is more likely than not to be sustained by the relevant taxing authority. The Company will recognize interest and penalties related to tax positions in income tax expense as applicable. |
Deferred Offering and Merger Costs | Deferred Offering and Merger Costs Offering and merger costs, consisting of legal, accounting, printer and filing fees were deferred to be offset against proceeds received when the Business Combination was completed. As of December 31, 2023, there were no deferred transaction costs because upon the close of the Business Combination, they were recorded against net proceeds in additional paid-in capital. For further discussion on the Business Combination, see Note 3. |
Defined Contribution Plan | Defined Contribution Plan The Company has a defined retirement savings plan under Section 401(k) of the Internal Revenue Code. This plan allows eligible employees to defer a portion of their annual compensation on a pre-tax basis. Effective January 1, 2023, the Company participates in a matching safe harbor 401(k) Plan with a Company contribution of up to 3.5% of each eligible participating employee’s compensation. Safe harbor contributions vest immediately for each participant. During the three and six months ended June 30, 2024, the Company made $135,000 and $222,000, respectively, in contributions under this safe harbor 401(k) Plan. During the three and six months ended June 30, 2023, the Company made $67,000 and $181,000, respectively, in contributions under this safe harbor 401(k) Plan. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is comprised of net loss and changes in unrealized gains and losses on the Company’s available-for-sale investments. |
Segment Reporting | Segment Reporting Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing performance. The Company’s CODM is its Chief Executive Officer. The Company has determined it operates in one segment. |
New Accounting Standards | New Accounting Standards In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Summary of Significant Accounting Policies | |
Schedule of property and equipment useful lives | Asset category Depreciable life Manufacturing equipment 10 years Office equipment 3 – 7 years Research and development equipment 7 years |
Business Combination and Reca_2
Business Combination and Recapitalization (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Business Combination and Recapitalization | |
Schedule of common stock following the consummation of business combination | The following table details the number of shares of Company Common Stock issued immediately following the consummation of the Business Combination: Number of Shares Common stock of HSAC2, outstanding prior to the Business Combination 6,762,117 Less: Redemption of HSAC2 shares (1,597,888) Common stock held by former HSAC2 shareholders 5,164,229 HSAC2 sponsor shares 4,450,000 Shares issued related to Backstop Agreement 1,808,512 Total shares outstanding prior to issuance of merger consideration to Legacy Orchestra stockholders 11,422,741 Shares issued to Legacy Orchestra stockholders – Company Common Stock (1) 20,191,338 Total shares of Company Common Stock immediately after Business Combination (2) 31,614,079 (1) The number of shares of common stock issued to Legacy Orchestra equity holders was determined based on (i) 2,522,214 shares of Legacy Orchestra Common Stock outstanding immediately prior to the closing of the Business Combination converted based on the Exchange Ratio and (ii) 35,694,179 shares of Legacy Orchestra Preferred Stock outstanding immediately prior to the Closing, which pursuant to their terms converted into Legacy Orchestra Common Stock immediately prior to the Closing and then converted into Company Common Stock based on the Exchange Ratio. All fractional shares were rounded down. (2) Excludes 8,000,000 shares of Company Common Stock issued or to be issued based on satisfaction of the Initial Milestone Event and the Final Milestone Event. On April 12, 2023, the Initial Milestone Event was achieved, and each Earnout Participant was issued their Pro Rata Portion (as such term is defined in the Merger Agreement) of 4,000,000 shares of Company Common Stock, resulting in a total of 3,999,987 shares of Company Common Stock being issued (less than 4,000,000 due to rounding). |
Schedule of reconciliation of business combination to statement of changes in stockholders equity | The following table reconciles the elements of the Business Combination to the Company’s condensed consolidated statements of stockholders’ equity (deficit) (in thousands): Amount Cash – HSAC2’s trust (net of redemption) $ 51,915 Cash – Backstop Agreement 18,085 Gross proceeds 70,000 Less: HSAC2 and Legacy Orchestra transaction costs paid (15,698) Effect of Business Combination, net of redemptions and transaction costs $ 54,302 |
Terumo Agreement (Tables)
Terumo Agreement (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Terumo Agreement. | |
Schedule of deferred revenue | Deferred Revenue – December 31, 2023 (in thousands) $ 17,433 Revenue recognized (1,125) Deferred Revenue – June 30, 2024 $ 16,308 Deferred Revenue – December 31, 2022 $ 19,539 Revenue recognized (1,747) Deferred Revenue – June 30, 2023 $ 17,792 |
Financial Instruments and Fai_2
Financial Instruments and Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Financial Instruments and Fair Value Measurements | |
Schedule of financial assets and liabilities measured at fair value | June 30, 2024 (in thousands) Level 1 Level 2 Level 3 Total Assets Money market fund (included in cash and cash equivalents) $ 12,463 $ — $ — $ 12,463 Marketable securities (Corporate and Government debt securities) — 41,468 — 41,468 Total assets $ 12,463 $ 41,468 $ — $ 53,931 December 31, 2023 (in thousands) Level 1 Level 2 Level 3 Total Assets Money market fund (included in cash and cash equivalents) $ 27,592 $ — $ — $ 27,592 Investment in Motus GI (see Note 7) 68 — — 68 Marketable securities (Corporate and Government debt securities) — 56,968 — 56,968 Total assets $ 27,660 $ 56,968 $ — $ 84,628 |
Schedule of liabilities for which fair value is determined by Level 3 | The following table presents a roll-forward of the aggregate fair values of the Company’s liabilities for which fair value is determined by Level 3 inputs (in thousands): Warrant Liability Balance—December 31, 2022 $ 2,089 Warrants exercised prior to the Business Combination (10) Change in fair value of warrants 294 Warrants reclassified to equity (2,373) Balance—June 30, 2023 $ — |
Marketable Securities and Str_2
Marketable Securities and Strategic Investments (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Marketable Securities and Strategic Investments | |
Schedule of marketable securities | June 30, 2024 Amortized Unrealized Unrealized Fair (in thousands) Cost Basis Gains Losses Value Corporate debt securities $ 41,490 $ 13 $ (35) $ 41,468 Total $ 41,490 $ 13 $ (35) $ 41,468 December 31, 2023 Amortized Unrealized Unrealized Fair (in thousands) Cost Basis Gains Losses Value Corporate debt securities $ 8,655 $ — $ (8) $ 8,647 Government debt securities 48,323 7 (9) 48,321 Total $ 56,978 $ 7 $ (17) $ 56,968 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Balance Sheet Components | |
Schedule of property and equipment balances, net | June 30, December 31, (in thousands) 2024 2023 Equipment $ 1,783 $ 1,777 Office furniture 437 343 Leasehold improvements 159 203 Property and equipment, gross 2,379 2,323 Less accumulated depreciation and amortization (1,144) (1,044) Total Property and equipment, net $ 1,235 $ 1,279 |
Schedule of accrued expenses | June 30, December 31, (in thousands) 2024 2023 Accrued compensation $ 1,772 $ 2,661 Clinical trial accruals 2,074 1,409 Other accrued expenses 379 1,079 Total accrued expenses $ 4,225 $ 5,149 |
Warrants (Tables)
Warrants (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Warrants | |
Schedule of fair value of the outstanding warrant liability | Period from January 1, 2023 to January 26, 2023 Expected volatility 44 – 49 % Risk-free interest rate 3.60 – 4.80 % Remaining term in years 0.35 – 5.00 Exercise price of common warrants $1.08 – $30.11 Common stock price $10.63 Expected dividend yield 0 % |
Schedule of warrant activity rollforward | The Company’s warrant liability related to Legacy Orchestra warrant activity rollforward is as follows, with the warrants having been converted to reflect the effect of the Merger: Common (in thousands, except share data) Warrants Amount Balance December 31, 2022 1,327,074 $ 2,089 Warrants exercised prior to the business combination (1,163) (10) Change in fair value of warrants as of January 26, 2023 — 294 Warrants reclassified to equity (1,325,911) (2,373) Balance March 31, 2023 — — Balance June 30, 2023 — $ — |
Schedule of purchase shares of Company Common Stock | The following table summarizes outstanding warrants to purchase shares of Company Common Stock as of June 30, 2024 and December 31, 2023: Number of Shares June 30, December 31, Exercise 2024 2023 Price Term Equity-classified Warrants Legacy Orchestra Warrants 507,841 507,841 $1.08 – $30.11 0.10 – 8.75 Avenue Warrants (Note 14) 27,707 27,707 $7.67 2.50 Private Warrants Held by Sponsor 750,000 750,000 $11.50 4.32 – 4.57 Private Warrants Held by Employees (Note 11) 660,000 660,000 $11.50 4.32 Total Outstanding 1,945,548 1,945,548 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Stock-Based Compensation | |
Schedule of cost related to stock-based compensation | Total stock-based compensation related to option issuances was as follows: Three Months Ended June 30, Six Months Ended June 30, (in thousands) 2024 2023 2024 2023 Research and development $ 308 $ 330 $ 817 $ 815 Selling, general and administrative 710 631 1,191 1,369 Total stock-based compensation $ 1,018 $ 961 $ 2,008 $ 2,184 Total stock-based compensation related to restricted stock awards and restricted stock units was as follows: Three Months Ended June 30, Six Months Ended June 30, (in thousands) 2024 2023 2024 2023 Research and development $ 392 $ — $ 739 $ — Selling, general and administrative 1,086 498 2,073 547 Total stock-based compensation $ 1,478 $ 498 $ 2,812 $ 547 Total stock-based compensation related to warrants was as follows: Three Months Ended June 30, Six Months Ended June 30, (in thousands) 2024 2023 2024 2023 Research and development $ 121 $ 120 $ 241 $ 207 Selling, general and administrative 144 128 288 258 Total stock-based compensation $ 265 $ 248 $ 529 $ 465 |
Schedule of stock option activity | Weighted Weighted Aggregate Shares Average Average Intrinsic Underlying Exercise Remaining Value Options Price Term (years) (in thousands) Outstanding at January 1, 2024 4,438,868 $ 7.72 7.70 $ 8,186 Granted 877,298 5.29 — — Exercised (45,159) 4.19 — — Forfeited/canceled (106,045) 10.00 — — Outstanding June 30, 2024 5,164,962 $ 7.29 7.69 $ 8,329 Exercisable at June 30, 2024 2,954,166 $ 7.35 6.63 $ 5,130 |
Schedule of restricted stock activity | Restricted Stock Weighted Average Awards/Units Grant Date Fair Outstanding Value Outstanding January 1, 2024 1,701,208 $ 7.39 Granted 796,880 5.12 Vested (22,302) 9.19 Forfeited/canceled — — Outstanding June 30, 2024 2,475,786 $ 6.68 |
Schedule of estimated grant-date fair value calculated using Black-Scholes option pricing model | Six Months Ended June 30, 2024 2023 Expected term (in years) 6.15 6.00 Expected volatility 71 % 50 % Risk-free interest rate 4.44 % 3.60 % Expected dividend yield 0 % 0 % Fair value of common stock $ 5.29 $ 9.63 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Leases | |
Schedule of recognized as an asset and operating lease liabilities | As of June 30, 2024: Weighted average remaining lease term – operating leases, in years 3.52 Weighted average discount rate – operating leases 9.44 % |
Schedule of future minimum rental payments, exclusive of taxes, insurance and other costs, under the leases | Operating Leases Year ending December 31: (in thousands) 2024 (remaining six months) $ 301 2025 339 2026 464 2027 476 2028 159 Thereafter — Total future minimum lease payments $ 1,739 Imputed interest (287) Total liability $ 1,452 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Net Loss Per Share | |
Schedule of calculation of diluted net loss per share | Three and Six Months Ended June 30, 2024 2023 Stock options 5,164,962 3,821,922 Company common stock warrants 1,945,548 1,966,808 Unvested restricted stock awards 2,475,786 49,237 Conversion option — 416,667 Forfeitable shares 500,000 500,000 Earnout consideration 4,000,000 4,000,000 Total 14,086,296 10,754,634 |
Organization and Basis of Pre_2
Organization and Basis of Presentation (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Organization and Basis of Presentation | ||
Accumulated deficit | $ (278,297) | $ (248,854) |
Business Combination | ||
Organization and Basis of Presentation | ||
Accumulated deficit | $ (278,300) |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Other (Details) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jan. 01, 2023 | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) segment | Jun. 30, 2023 USD ($) | Dec. 31, 2023 USD ($) | |
Summary of Significant Accounting Policies | ||||||
Strategic investments | $ 2,495,000 | $ 2,495,000 | $ 2,495,000 | |||
Allowance for doubtful accounts receivable | 0 | 0 | 0 | |||
Inventory impairment charge | 0 | 0 | ||||
Impairment of long-lived assets | 0 | |||||
Deferred offering deposit | 0 | |||||
Defined contribution plan, percentage | 3.50% | |||||
Contribution | 135,000 | $ 67,000 | $ 222,000 | $ 181,000 | ||
Number of operating segments | segment | 1 | |||||
Terumo Agreement | ||||||
Summary of Significant Accounting Policies | ||||||
Term of billing from date of milestone achievement | 10 days | |||||
Term of royalty payments from close of each quarter | 20 days | |||||
Term of optional services from receipt of invoice | 20 days | |||||
Term of SirolimusERF from receipt of shipping invoice | 30 days | |||||
Strategic Investments Less Current Portion | ||||||
Summary of Significant Accounting Policies | ||||||
Strategic investments | $ 2,500,000 | $ 2,500,000 | $ 2,500,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of property and equipment (Details) | Jun. 30, 2024 |
Manufacturing Equipment | |
Schedule of Property and Equipment, Net | |
Total asset category | 10 years |
Office Equipment | Minimum | |
Schedule of Property and Equipment, Net | |
Total asset category | 3 years |
Office Equipment | Maximum | |
Schedule of Property and Equipment, Net | |
Total asset category | 7 years |
Research and Development Equipment | |
Schedule of Property and Equipment, Net | |
Total asset category | 7 years |
Business Combination and Reca_3
Business Combination and Recapitalization - Other (Details) $ / shares in Units, $ in Millions | Apr. 12, 2023 shares | Jan. 30, 2023 USD ($) | Jan. 26, 2023 USD ($) D employee $ / shares shares | Jan. 25, 2023 shares | Jan. 20, 2023 USD ($) | Jul. 04, 2022 USD ($) $ / shares | Jun. 30, 2024 $ / shares shares | Dec. 31, 2023 $ / shares shares |
Business Combination and Recapitalization | ||||||||
Common stock, shares authorized | 340,000,000 | 340,000,000 | ||||||
Common stock, par value (in Dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||
Preference shares, shares authorized | 10,000,000 | 10,000,000 | ||||||
Preference shares, par value (in Dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||
HSAC 2 Holdings, LLC | ||||||||
Business Combination and Recapitalization | ||||||||
Sponsor share forfeiture (as percent) | 25% | |||||||
Number of shares forfeiture by sponsor | 1,000,000 | |||||||
Insider shares subject to lock up period | 4,000,000 | |||||||
Private shares subject to lock up period | 450,000 | |||||||
Share lock up period | 12 months | |||||||
Number of warrants issued | 750,000 | |||||||
Number of employees and directors, warrants issued | employee | 11 | |||||||
Number of shares issuable as earnout consideration | 500,000 | |||||||
HSAC 2 Holdings, LLC | Private warrants | ||||||||
Business Combination and Recapitalization | ||||||||
Sponsor warrant forfeiture (as percent) | 50% | |||||||
Warrants outstanding (in shares) | 1,500,000 | |||||||
Number of warrants forfeiture by sponsor | 750,000 | |||||||
Consideration for forfeiture of warrants | $ | $ 0 | |||||||
HSAC 2 Holdings, LLC | Initial milestone event | ||||||||
Business Combination and Recapitalization | ||||||||
Number of shares forfeiture by sponsor | 500,000 | |||||||
Sponsor share forfeiture, stock price trigger | $ / shares | $ 15 | |||||||
Sponsor share forfeiture, threshold trading days | D | 20 | |||||||
Sponsor share forfeiture, threshold consecutive trading days | D | 30 | |||||||
HSAC 2 Holdings, LLC | Final milestone event | ||||||||
Business Combination and Recapitalization | ||||||||
Number of shares forfeiture by sponsor | 500,000 | |||||||
Sponsor share forfeiture, stock price trigger | $ / shares | $ 20 | |||||||
Sponsor share forfeiture, threshold trading days | D | 20 | |||||||
Sponsor share forfeiture, threshold consecutive trading days | D | 30 | |||||||
HSAC 2 Holdings, LLC | Exercisable 24 months after the Closing | ||||||||
Business Combination and Recapitalization | ||||||||
Warrants exercisable term | 24 months | |||||||
HSAC 2 Holdings, LLC | Exercisable 36 months after the Closing | ||||||||
Business Combination and Recapitalization | ||||||||
Warrants exercisable (as a percent) | 50% | |||||||
Warrants exercisable term | 36 months | |||||||
HSAC2 | ||||||||
Business Combination and Recapitalization | ||||||||
Insider shares subject to lock up period | 4,000,000 | |||||||
Private shares subject to lock up period | 450,000 | |||||||
Share lock up period | 12 months | |||||||
Number of warrants issued | 750,000 | |||||||
Number of employees and directors, warrants issued | employee | 11 | |||||||
Percent of shareholders elected to participate in earnout | 91% | |||||||
HSAC2 | RTW Funds and Covidien Group | Forward purchase agreement | ||||||||
Business Combination and Recapitalization | ||||||||
Aggregate amount of shares to be issued | $ | $ 10 | |||||||
HSAC2 | Medtronic | Forward purchase agreement | ||||||||
Business Combination and Recapitalization | ||||||||
Value of shares issued | $ | $ 0.1 | $ 9.9 | ||||||
HSAC2 | RTW Funds | Backstop agreement | ||||||||
Business Combination and Recapitalization | ||||||||
Share issue price (in dollars per share) | $ / shares | $ 10 | |||||||
Threshold remaining working capital and trust account for share issue | $ | $ 60 | |||||||
Shares issued (in shares) | 1,808,512 | |||||||
HSAC2 | Minimum | ||||||||
Business Combination and Recapitalization | ||||||||
Share lock up period | 6 months | |||||||
HSAC2 | Maximum | ||||||||
Business Combination and Recapitalization | ||||||||
Share lock up period | 12 months | |||||||
Number of shares issuable as earnout consideration | 8,000,000 | |||||||
HSAC2 | Initial milestone event | ||||||||
Business Combination and Recapitalization | ||||||||
Number of shares issuable as earnout consideration | 4,000,000 | 4,000,000 | ||||||
Number of shares issuable as earnout consideration due to rounding | 3,999,987 | |||||||
HSAC2 | Initial milestone event | Maximum | ||||||||
Business Combination and Recapitalization | ||||||||
Number of shares issuable as earnout consideration | 4,000,000 | |||||||
HSAC2 | Final milestone event | ||||||||
Business Combination and Recapitalization | ||||||||
Number of shares issuable as earnout consideration | 4,000,000 | |||||||
HSAC2 | Exercisable 24 months after the Closing | ||||||||
Business Combination and Recapitalization | ||||||||
Warrants exercisable (as a percent) | 50% | |||||||
Warrants exercisable term | 24 months | |||||||
HSAC2 | Exercisable 36 months after the Closing | ||||||||
Business Combination and Recapitalization | ||||||||
Warrants exercisable (as a percent) | 50% | |||||||
Warrants exercisable term | 36 months | |||||||
HSAC2 | ||||||||
Business Combination and Recapitalization | ||||||||
Shares authorized (in shares) | 350,000,000 | |||||||
Common stock, shares authorized | 340,000,000 | |||||||
Common stock, par value (in Dollars per share) | $ / shares | $ 0.0001 | |||||||
Preference shares, shares authorized | 10,000,000 | |||||||
Preference shares, par value (in Dollars per share) | $ / shares | $ 0.0001 | |||||||
Goodwill | $ | $ 0 | |||||||
Intangible assets | $ | $ 0 | |||||||
HSAC2 | Officer And Director Warrants | ||||||||
Business Combination and Recapitalization | ||||||||
Number of warrants forfeiture by sponsor | 90,000 |
Business Combination and Reca_4
Business Combination and Recapitalization - Common stock outstanding (Details) - shares | 6 Months Ended | |||
Apr. 12, 2023 | Jan. 26, 2023 | Jun. 30, 2024 | Dec. 31, 2023 | |
Business Combination and Recapitalization | ||||
Common stock of HSAC2, outstanding prior to the Business Combination | 35,777,412 | |||
Total shares of Company Common Stock immediately after Business Combination | 35,824,571 | |||
Common stock, shares outstanding | 35,824,571 | 35,777,412 | ||
Preference shares, shares outstanding | 0 | 0 | ||
Legacy Orchestra | ||||
Business Combination and Recapitalization | ||||
Common stock of HSAC2, outstanding prior to the Business Combination | 6,762,117 | |||
Less: Redemption of HSAC2 shares | (1,597,888) | |||
Common stock held by former HSAC2 shareholders | 5,164,229 | |||
HSAC2 sponsor shares | 4,450,000 | |||
Shares issued related to Backstop Agreement | 1,808,512 | |||
Total shares outstanding prior to issuance of merger consideration to Legacy Orchestra stockholders | 11,422,741 | |||
Shares issued to Legacy Orchestra stockholders - Company Common Stock | 20,191,338 | |||
Total shares of Company Common Stock immediately after Business Combination | 31,614,079 | 2,522,214 | ||
Common stock, shares outstanding | 31,614,079 | 2,522,214 | ||
Preference shares, shares outstanding | 35,694,179 | |||
Number of shares issuable as earnout consideration | 4,000,000 | 8,000,000 | ||
Number of shares issuable as earnout consideration due to rounding | 3,999,987 |
Business Combination and Reca_5
Business Combination and Recapitalization - Schedule of reconciliation of business combination elements to changes in equity (Details) - HSAC2 - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Business Combination and Recapitalization | ||
Cash - HSAC2's trust (net of redemption) | $ 51,915 | |
Cash - Backstop Agreement | 18,085 | |
Gross proceeds | 70,000 | |
Deferred financing, offering and merger costs | (15,698) | |
Effect of Business Combination, net of redemptions and transaction costs | 54,302 | |
Proceeds from reverse recapitalization | $ 56,800 | |
Legacy Orchestra | ||
Business Combination and Recapitalization | ||
Transaction costs | $ 2,500 |
Terumo Agreement - Other (Detai
Terumo Agreement - Other (Details) - Collaborative Arrangement - Terumo - USD ($) | 1 Months Ended | 12 Months Ended | |
Jun. 30, 2019 | Dec. 31, 2019 | Jun. 30, 2022 | |
Terumo Agreement | |||
Upfront payment received | $ 30,000,000 | $ 30,000,000 | |
Equity commitment | 5,000,000 | ||
Amount invested for financing | 2,500,000 | ||
Amount receivable on Milestones | 35,000,000 | ||
Arrangement, Milestone Payment Amount, Target Achievement Dates Passed | 3 | ||
Target milestone payment date already passed | $ 5,000,000 | ||
Remaining time-based milestones by the specified target achievement | $ 20,000,000 | ||
Stock purchase and the revenue generating elements | 32,500,000 | ||
Estimated fair value of the shares | 2,500,000 | ||
Transaction price | $ 30,000,000 | ||
Minimum | |||
Terumo Agreement | |||
Royalty receivable percentage | 10% | ||
Sales-based royalties percentage | 10% | ||
Maximum | |||
Terumo Agreement | |||
Additional payments on the achievement milestone | $ 65,000,000 | ||
Royalty receivable percentage | 15% | ||
Sales-based royalties percentage | 15% |
Terumo Agreement - Deferred rev
Terumo Agreement - Deferred revenue (Details) - Collaborative Arrangement - Terumo - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Changes in the Company's deferred revenue balance | ||
Deferred Revenue - Beginning balance | $ 17,433 | $ 19,539 |
Revenue recognized | (1,125) | (1,747) |
Deferred Revenue - Ending balance | $ 16,308 | $ 17,792 |
Terumo Agreement - Remaining pe
Terumo Agreement - Remaining performance obligation (Details) $ in Millions | Jun. 30, 2024 USD ($) |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-07-01 | |
Terumo Agreement | |
Revenue remaining performance obligation amount | $ 12.7 |
Remaining performance obligation recognition period | 24 months |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2024-07-01 | |
Terumo Agreement | |
Revenue remaining performance obligation amount | $ 3.7 |
Remaining performance obligation recognition period | 12 months |
Terumo Agreement - Other narrat
Terumo Agreement - Other narratives (Details) - Collaborative Arrangement - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Terumo Agreement | ||||
Estimated total costs increase (decrease) percentage | 2.50% | |||
Terumo | ||||
Terumo Agreement | ||||
Cost incurred | $ 4,000,000 | $ 4,500,000 | $ 6,900,000 | $ 8,300,000 |
Estimated total costs increase (decrease) percentage | 2.80% | |||
Increase (decrease) in revenue from change in estimate | $ (220,000) | $ (392,000) | $ (382,000) | $ (303,000) |
Collaborative Arrangement, Change in Estimate, Increase (Decrease) in Earnings Per Share , Basic | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 |
Collaborative Arrangement, Change in Estimate, Increase (Decrease) in Earnings Per Share | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 |
Medtronic Agreement (Details)
Medtronic Agreement (Details) - Medtronic Agreement - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Medtronic agreement | ||||
Reimbursable research and development expense | $ 1,900,000 | $ 1,000,000 | $ 3,100,000 | $ 2,300,000 |
Proceeds from issuance of Series D-2 Preferred Stock | 40,000,000 | |||
Revenue recognized to date | $ 0 | 0 | ||
Minimum | ||||
Medtronic agreement | ||||
Expected to receive product price | 500 | |||
Maximum | ||||
Medtronic agreement | ||||
Expected to receive product price | 1,600 | |||
Accounts Payable and Accrued Expenses | ||||
Medtronic agreement | ||||
Reimbursable research and development expense | $ 2,800,000 |
Financial Instruments and Fai_3
Financial Instruments and Fair Value Measurements - Schedule of financial assets and liabilities measured at fair value (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 | Dec. 31, 2023 | |
Financial assets and liabilities measured at fair value | ||
Total assets | $ 53,931 | $ 84,628 |
Assets transfers within levels | 0 | 0 |
Liabilities transfers within levels | 0 | 0 |
Money market fund | ||
Financial assets and liabilities measured at fair value | ||
Total assets | 12,463 | 27,592 |
Investment in Motus GI | ||
Financial assets and liabilities measured at fair value | ||
Total assets | 68 | |
Marketable securities (Corporate and Government debt securities) | ||
Financial assets and liabilities measured at fair value | ||
Total assets | 41,468 | 56,968 |
Level 1 | ||
Financial assets and liabilities measured at fair value | ||
Total assets | 12,463 | 27,660 |
Level 1 | Money market fund | ||
Financial assets and liabilities measured at fair value | ||
Total assets | 12,463 | 27,592 |
Level 1 | Investment in Motus GI | ||
Financial assets and liabilities measured at fair value | ||
Total assets | 68 | |
Level 2 | ||
Financial assets and liabilities measured at fair value | ||
Total assets | 41,468 | 56,968 |
Level 2 | Marketable securities (Corporate and Government debt securities) | ||
Financial assets and liabilities measured at fair value | ||
Total assets | $ 41,468 | $ 56,968 |
Financial Instruments and Fai_4
Financial Instruments and Fair Value Measurements - Schedules of liabilities for which fair value is determined by Level 3 (Details) - Warrants $ in Thousands | 6 Months Ended |
Jun. 30, 2023 USD ($) | |
Roll-forward of liabilities determined by Level 3 inputs | |
Balance - beginning | $ 2,089 |
Warrants exercised prior to the Business Combination | (10) |
Change in fair value of warrants | 294 |
Warrants reclassified to equity | (2,373) |
Balance - ending | $ 0 |
Marketable Securities and Str_3
Marketable Securities and Strategic Investments (Details) € in Millions | 3 Months Ended | 6 Months Ended | ||||||
Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2022 USD ($) | Dec. 31, 2019 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Dec. 31, 2023 USD ($) | May 31, 2022 EUR (€) | |
Marketable Securities and Strategic Investments | ||||||||
Recognized gains (loss) | $ 0 | $ 0 | ||||||
Investments fair value | $ 68,000 | |||||||
Debt securities with maturities between 12 and 36 months | $ 12,700,000 | 12,700,000 | ||||||
Strategic investments Motus GI | ||||||||
Marketable Securities and Strategic Investments | ||||||||
Realized losses | 23,000 | $ (31,000) | 68,000 | 17,000 | ||||
Investments fair value | $ 0 | 0 | $ 68,000 | |||||
Impairment charge | $ 0 | $ 0 | ||||||
Strategic Investment Vivasure | ||||||||
Marketable Securities and Strategic Investments | ||||||||
Investments gain | $ 1,900,000 | |||||||
Impairment charge | $ 5,800,000 | |||||||
Haemonetics Corporation | Strategic Investment Vivasure | ||||||||
Marketable Securities and Strategic Investments | ||||||||
Investments fair value | € | € 30 |
Marketable Securities and Str_4
Marketable Securities and Strategic Investments - Schedule of marketable securities (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Marketable Securities | ||
Amortized Cost Basis | $ 41,490 | $ 56,978 |
Unrealized Gains | 13 | 7 |
Unrealized Losses | (35) | (17) |
Fair Value | 41,468 | 56,968 |
Corporate Debt Securities | ||
Marketable Securities | ||
Amortized Cost Basis | 41,490 | 8,655 |
Unrealized Gains | 13 | |
Unrealized Losses | (35) | (8) |
Fair Value | $ 41,468 | 8,647 |
Government debt securities | ||
Marketable Securities | ||
Amortized Cost Basis | 48,323 | |
Unrealized Gains | 7 | |
Unrealized Losses | (9) | |
Fair Value | $ 48,321 |
Balance Sheet Components - Othe
Balance Sheet Components - Other (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Balance Sheet Components | ||||
Depreciation and amortization expense | $ 74,000 | $ 72,000 | $ 148,000 | $ 144,000 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of property and equipment, net (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Schedule of Property and Equipment, Net | ||
Property and equipment, gross | $ 2,379 | $ 2,323 |
Less accumulated depreciation and amortization | (1,144) | (1,044) |
Total Property and equipment, net | 1,235 | 1,279 |
Equipment | ||
Schedule of Property and Equipment, Net | ||
Property and equipment, gross | 1,783 | 1,777 |
Office Equipment | ||
Schedule of Property and Equipment, Net | ||
Property and equipment, gross | 437 | 343 |
Leasehold Improvements | ||
Schedule of Property and Equipment, Net | ||
Property and equipment, gross | $ 159 | $ 203 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of accrued expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Balance Sheet Components | ||
Accrued compensation | $ 1,772 | $ 2,661 |
Clinical trial accruals | 2,074 | 1,409 |
Other accrued expenses | 379 | 1,079 |
Total accrued expenses | $ 4,225 | $ 5,149 |
Common and Preferred Stock (Det
Common and Preferred Stock (Details) - $ / shares | Jun. 30, 2024 | Dec. 31, 2023 |
Common Stock | ||
Common stock, shares authorized | 340,000,000 | 340,000,000 |
Common stock, par value (in Dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred Stock | ||
Preference shares, shares authorized | 10,000,000 | 10,000,000 |
Preference shares, par value (in Dollars per share) | $ 0.0001 | $ 0.0001 |
Preference shares, shares outstanding | 0 | 0 |
Common and Preferred Stock - At
Common and Preferred Stock - At-the-Market Offering and Shelf Registration Statement (Details) - USD ($) $ in Millions | 6 Months Ended | |
Jun. 30, 2024 | May 15, 2024 | |
Common and Preferred Stock | ||
Total aggregate offering price of common stock | $ 300 | |
Open Market Sale Agreement | ||
Common and Preferred Stock | ||
Aggregate offering price of common stock | $ 100 | |
Shares issued (in shares) | 0 |
Warrants - Other (Details)
Warrants - Other (Details) | 6 Months Ended | ||||
Oct. 06, 2023 USD ($) $ / shares shares | Jan. 26, 2023 USD ($) employee shares | Jun. 30, 2024 $ / shares shares | Dec. 31, 2023 shares | Dec. 31, 2022 USD ($) | |
Warrants | |||||
Price per share (in dollars per share) | $ / shares | $ 11.50 | ||||
Exercise Price | $ / shares | $ 11.50 | ||||
Warrant liability, Fair value | $ | $ 2,400,000 | $ 2,100,000 | |||
Expected volatility | Minimum | |||||
Warrants | |||||
Warrants, measurement input | 44 | ||||
Expected volatility | Maximum | |||||
Warrants | |||||
Warrants, measurement input | 49 | ||||
Risk-free interest rate | |||||
Warrants | |||||
Warrants, measurement input | 4.98 | ||||
Risk-free interest rate | Minimum | |||||
Warrants | |||||
Warrants, measurement input | 3.60 | ||||
Risk-free interest rate | Maximum | |||||
Warrants | |||||
Warrants, measurement input | 4.80 | ||||
HSAC2 | |||||
Warrants | |||||
Insider shares subject to lock up period | 4,000,000 | ||||
Private shares subject to lock up period | 450,000 | ||||
Share lock up period | 12 months | ||||
Number of warrants issued | 750,000 | ||||
Number of employees and directors, warrants issued | employee | 11 | ||||
HSAC2 | Minimum | |||||
Warrants | |||||
Share lock up period | 6 months | ||||
HSAC2 | Maximum | |||||
Warrants | |||||
Share lock up period | 12 months | ||||
HSAC2 | Exercisable 24 months after the Closing | |||||
Warrants | |||||
Warrants exercisable term | 24 months | ||||
Warrants exercisable (as a percent) | 50% | ||||
HSAC2 | Exercisable 36 months after the Closing | |||||
Warrants | |||||
Warrants exercisable term | 36 months | ||||
Warrants exercisable (as a percent) | 50% | ||||
Private Warrants Held by Sponsor | |||||
Warrants | |||||
Warrants outstanding (in shares) | 1,500,000 | 750,000 | 750,000 | ||
Price per share (in dollars per share) | $ / shares | $ 11.50 | ||||
Warrants exercisable term | 30 days | ||||
Warrants expiry term | 5 years | ||||
Exercise Price | $ / shares | $ 11.50 | ||||
Private Warrants Held by Sponsor | Minimum | |||||
Warrants | |||||
Warrants expiry term | 4 years 3 months 25 days | ||||
Private Warrants Held by Sponsor | Maximum | |||||
Warrants | |||||
Warrants expiry term | 4 years 6 months 25 days | ||||
Private Warrants Held by Sponsor | HSAC2 | |||||
Warrants | |||||
Warrants outstanding (in shares) | 1,500,000 | ||||
Sponsor warrant forfeiture (as percent) | 50% | ||||
Number of warrants forfeiture by sponsor | 750,000 | ||||
Consideration for forfeiture of warrants | $ | $ 0 | ||||
Avenue Warrants | |||||
Warrants | |||||
Warrants outstanding (in shares) | 27,707 | 27,707 | |||
Price per share (in dollars per share) | $ / shares | $ 7.67 | $ 7.67 | |||
Warrants expiry term | 2 years 6 months | ||||
Number of warrants issued | 27,707 | ||||
Exercise Price | $ / shares | $ 7.67 | $ 7.67 | |||
Cash payment with respect to certain fees | $ | $ 212,500 | ||||
Warrant liability, Fair value | $ | $ 66,000 | ||||
Avenue Warrants | Expected volatility | |||||
Warrants | |||||
Warrants, measurement input | 42 | ||||
Officer And Director Warrants | HSAC2 | |||||
Warrants | |||||
Number of warrants forfeiture by sponsor | 90,000 |
Warrants - Valuation models for
Warrants - Valuation models for Warrants (Details) $ in Millions | Oct. 06, 2023 | Jan. 26, 2023 USD ($) $ / shares Y | Dec. 31, 2022 USD ($) |
Warrants | |||
Warrant liability, Fair value | $ | $ 2.4 | $ 2.1 | |
Expected volatility | Minimum | |||
Warrants | |||
Warrants, measurement input | 44 | ||
Expected volatility | Maximum | |||
Warrants | |||
Warrants, measurement input | 49 | ||
Risk-free interest rate | |||
Warrants | |||
Warrants, measurement input | 4.98 | ||
Risk-free interest rate | Minimum | |||
Warrants | |||
Warrants, measurement input | 3.60 | ||
Risk-free interest rate | Maximum | |||
Warrants | |||
Warrants, measurement input | 4.80 | ||
Remaining Term (in Years) | Minimum | |||
Warrants | |||
Warrants, measurement input | Y | 0.35 | ||
Remaining Term (in Years) | Maximum | |||
Warrants | |||
Warrants, measurement input | Y | 5 | ||
Stock price | |||
Warrants | |||
Warrants, measurement input | 10.63 | ||
Expected dividend yield | |||
Warrants | |||
Warrants, measurement input | 0 | ||
Commons Warrants | Exercise price | Minimum | |||
Warrants | |||
Warrants, measurement input | 1.08 | ||
Commons Warrants | Exercise price | Maximum | |||
Warrants | |||
Warrants, measurement input | 30.11 |
Warrants - Assumed Legacy Orche
Warrants - Assumed Legacy Orchestra Warrants (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) shares | |
Warrants | |
Warrants beginning balance (Amount) | $ 2,089 |
Warrants exercised (Amount) | (10) |
Change in the fair value of warrants (Amount) | 294 |
Warrants reclassified to equity (Amount) | $ (2,373) |
Commons Warrants | |
Warrants | |
Warrants beginning balance (Number) | shares | 1,327,074 |
Exercise of warrants | shares | (1,163) |
Warrants reclassified to equity | shares | (1,325,911) |
Warrants - Private Warrants and
Warrants - Private Warrants and Assumed Legacy Orchestra Warrants (Details) - $ / shares | Jun. 30, 2024 | Dec. 31, 2023 | Oct. 06, 2023 | Jan. 26, 2023 |
Warrants | ||||
Exercise Price | $ 11.50 | |||
Equity-classified Warrants | ||||
Warrants | ||||
Warrants | 1,945,548 | 1,945,548 | ||
Legacy Orchestra Warrants | ||||
Warrants | ||||
Warrants | 507,841 | 507,841 | ||
Legacy Orchestra Warrants | Minimum | ||||
Warrants | ||||
Exercise Price | $ 1.08 | |||
Term | 1 month 6 days | |||
Legacy Orchestra Warrants | Maximum | ||||
Warrants | ||||
Exercise Price | $ 30.11 | |||
Term | 8 years 9 months | |||
Avenue Warrants | ||||
Warrants | ||||
Warrants | 27,707 | 27,707 | ||
Exercise Price | $ 7.67 | $ 7.67 | ||
Term | 2 years 6 months | |||
Private Warrants Held by Sponsor | ||||
Warrants | ||||
Warrants | 750,000 | 750,000 | 1,500,000 | |
Exercise Price | $ 11.50 | |||
Term | 5 years | |||
Private Warrants Held by Sponsor | Minimum | ||||
Warrants | ||||
Term | 4 years 3 months 25 days | |||
Private Warrants Held by Sponsor | Maximum | ||||
Warrants | ||||
Term | 4 years 6 months 25 days | |||
Private Warrants Held by Employees | ||||
Warrants | ||||
Warrants | 660,000 | 660,000 | ||
Exercise Price | $ 11.50 | |||
Term | 4 years 3 months 25 days |
Stock-Based Compensation - Othe
Stock-Based Compensation - Other (Details) - shares | 3 Months Ended | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 | Jun. 30, 2024 | Dec. 31, 2023 | |
2018 Plan | |||
Stock-Based Compensation | |||
Shares available for future issuance | 0 | 0 | |
2018 Plan | Legacy Orchestra | |||
Stock-Based Compensation | |||
Number of shares authorized | 5,200,000 | 5,200,000 | |
2018 Plan | Legacy Orchestra | Maximum | |||
Stock-Based Compensation | |||
Expiration period (in years) | 10 years | ||
Vesting period (in years) | 3 years | ||
2023 Plan | |||
Stock-Based Compensation | |||
Number of shares authorized | 1,400,000 | 1,400,000 | |
2023 Plan | Legacy Orchestra | |||
Stock-Based Compensation | |||
Percentage of shares outstanding | 4.80% | ||
Shares available for future issuance | 3,036,722 | 3,036,722 | |
Officer And Director Warrants | Legacy Orchestra | |||
Stock-Based Compensation | |||
Number of warrants forfeiture by sponsor | 0 | 0 | 90,000 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of cost related to stock-based compensation (Details) - 2023 Plan - Legacy Orchestra - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Employee Stock Option | ||||
Stock-Based Compensation | ||||
Total stock-based compensation | $ 1,018 | $ 961 | $ 2,008 | $ 2,184 |
Unrecognized stock-based compensation expense for options | 7,500 | $ 7,500 | ||
Expected period to be recognized | 2 years 6 months | |||
Employee Stock Option | Research and development | ||||
Stock-Based Compensation | ||||
Total stock-based compensation | 308 | 330 | $ 817 | 815 |
Employee Stock Option | Selling, general and administrative | ||||
Stock-Based Compensation | ||||
Total stock-based compensation | 710 | 631 | 1,191 | 1,369 |
Restricted Stock | ||||
Stock-Based Compensation | ||||
Total stock-based compensation | 1,478 | 498 | 2,812 | 547 |
Unrecognized stock-based compensation expense for options | 11,600 | $ 11,600 | ||
Expected period to be recognized | 2 years 4 months 24 days | |||
Restricted Stock | Research and development | ||||
Stock-Based Compensation | ||||
Total stock-based compensation | 392 | $ 739 | ||
Restricted Stock | Selling, general and administrative | ||||
Stock-Based Compensation | ||||
Total stock-based compensation | 1,086 | 498 | 2,073 | 547 |
Warrant | ||||
Stock-Based Compensation | ||||
Total stock-based compensation | 265 | 248 | 529 | 465 |
Unrecognized stock-based compensation expense for options | 1,700 | $ 1,700 | ||
Expected period to be recognized | 1 year 7 months 6 days | |||
Warrant | Research and development | ||||
Stock-Based Compensation | ||||
Total stock-based compensation | 121 | 120 | $ 241 | 207 |
Warrant | Selling, general and administrative | ||||
Stock-Based Compensation | ||||
Total stock-based compensation | $ 144 | $ 128 | $ 288 | $ 258 |
Stock-Based Compensation - Weig
Stock-Based Compensation - Weighted Average Assumptions (Details) | 6 Months Ended | ||||
Jun. 30, 2024 USD ($) employee shares | Dec. 31, 2023 shares | Oct. 06, 2023 | Jan. 26, 2023 USD ($) $ / shares | Dec. 31, 2022 USD ($) | |
Stock-Based Compensation | |||||
Warrant liability, Fair value | $ | $ 2,400,000 | $ 2,100,000 | |||
Risk-free interest rate | |||||
Stock-Based Compensation | |||||
Warrants, measurement input | 4.98 | ||||
Expected dividend yield | |||||
Stock-Based Compensation | |||||
Warrants, measurement input | 0 | ||||
Fair value of common stock | |||||
Stock-Based Compensation | |||||
Warrants, measurement input | $ / shares | 10.63 | ||||
Legacy Orchestra Warrants | Restricted Stock | 2023 Plan | |||||
Stock-Based Compensation | |||||
Number of warrants to be issued | shares | 750,000 | ||||
Warrants outstanding (in shares) | shares | 660,000 | ||||
Number of employees and directors, warrants issued | employee | 11 | ||||
Legacy Orchestra Warrants | Restricted Stock | Exercisable 24 months after the Closing | 2023 Plan | |||||
Stock-Based Compensation | |||||
Warrants exercisable (as a percent) | 50% | ||||
Warrants exercisable term | 24 months | ||||
Legacy Orchestra Warrants | Restricted Stock | Exercisable 36 months after the Closing | 2023 Plan | |||||
Stock-Based Compensation | |||||
Warrants exercisable (as a percent) | 50% | ||||
Warrants exercisable term | 36 months | ||||
Legacy Orchestra Warrants | Remaining Term (in Years) | Restricted Stock | 2023 Plan | |||||
Stock-Based Compensation | |||||
Warrants, measurement input | 5 | ||||
Legacy Orchestra Warrants | Expected volatility | Restricted Stock | 2023 Plan | |||||
Stock-Based Compensation | |||||
Warrants, measurement input | 50 | ||||
Legacy Orchestra Warrants | Risk-free interest rate | Restricted Stock | 2023 Plan | |||||
Stock-Based Compensation | |||||
Warrants, measurement input | 3.54 | ||||
Legacy Orchestra Warrants | Expected dividend yield | Restricted Stock | 2023 Plan | |||||
Stock-Based Compensation | |||||
Warrants, measurement input | 0 | ||||
Legacy Orchestra Warrants | Fair value of common stock | Restricted Stock | 2023 Plan | |||||
Stock-Based Compensation | |||||
Warrant liability, Fair value | $ | $ 10.63 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of stock option activity (Details) - 2018 and 2023 Plan - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Shares Underlying Options | |||
Shares Underlying Options, Beginning | 4,438,868 | ||
Shares Underlying Options, Granted | 877,298 | ||
Shares Underlying Options, Exercised | (45,159) | ||
Shares Underlying Options, Forfeited/canceled | (106,045) | ||
Shares Underlying Options, Ending | 5,164,962 | 4,438,868 | |
Shares Underlying Options, Exercisable | 2,954,166 | ||
Weighted Average Exercise Price | |||
Weighted Average Exercise Price Outstanding, Outstanding at January 1, 2024 | $ 7.72 | ||
Weighted Average Exercise Price, Granted | 5.29 | ||
Weighted Average Exercise Price, Exercised | 4.19 | ||
Weighted Average Exercise Price, Forfeited/canceled | 10 | ||
Weighted Average Exercise Price, Outstanding June 30, 2024 | 7.29 | $ 7.72 | |
Weighted Average Exercise Price, Exercisable at June 30, 2024 | $ 7.35 | ||
Weighted Average Remaining Term (years) and Aggregate Intrinsic Value | |||
Weighted Average Remaining Term (years), Outstanding | 7 years 8 months 8 days | 7 years 8 months 12 days | |
Weighted Average Remaining Term (years), Exercisable | 6 years 7 months 17 days | ||
Aggregate Intrinsic Value Outstanding | $ 8,329 | $ 8,186 | |
Aggregate Intrinsic Value, Exercisable | $ 5,130 | ||
Weighted average grant date fair value | $ 3.56 | $ 4.99 |
Stock-Based Compensation - Sc_3
Stock-Based Compensation - Schedule of restricted stock activity (Details) | 6 Months Ended |
Jun. 30, 2024 $ / shares shares | |
Restricted Stock | |
Restricted Stock Outstanding | |
Restricted stock, Beginning | 1,701,208 |
Restricted stock, Granted | 796,880 |
Restricted stock, Vested | (22,302) |
Restricted stock, Ending | 2,475,786 |
Weighted Average Grant Date Fair Value | |
Weighted Average Grant Date Fair Value, Beginning | $ / shares | $ 7.39 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | 5.12 |
Weighted Average Grant Date Fair Value, Vested | $ / shares | 9.19 |
Weighted Average Grant Date Fair Value, Ending | $ / shares | $ 6.68 |
Performance-Based Restricted Stock Awards | |
Restricted Stock Outstanding | |
Restricted stock, Granted | 0 |
Stock-Based Compensation - Sc_4
Stock-Based Compensation - Schedule of estimated grant-date fair value calculated using Black-Scholes option pricing model (Details) - Employee Stock Option - $ / shares | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Stock-Based Compensation | ||
Expected term | 6 years 1 month 24 days | 6 years |
Expected volatility | 71% | 50% |
Risk-free interest rate | 4.44% | 3.60% |
Expected dividend yield | 0% | 0% |
Fair value of common stock | $ 5.29 | $ 9.63 |
Leases - Other (Details)
Leases - Other (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||
May 31, 2022 USD ($) | Jan. 31, 2020 USD ($) | Nov. 30, 2019 USD ($) ft² | Jan. 31, 2019 USD ($) ft² | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Nov. 30, 2022 ft² | |
Leases | |||||||||
Lease space | ft² | 5,200 | 8,052 | 7,800 | ||||||
Rent lease expense | $ 224,000 | $ 209,000 | $ 443,000 | $ 417,000 | |||||
Cash paid for operating lease liabilities | $ 454,000 | $ 410,000 | |||||||
Minimum | |||||||||
Leases | |||||||||
Monthly rent expense | $ 7,000 | $ 12,000 | $ 28,000 | $ 9,000 | |||||
Maximum | |||||||||
Leases | |||||||||
Monthly rent expense | $ 23,000 | $ 17,000 | $ 40,000 | $ 19,000 |
Leases - Schedule of recognized
Leases - Schedule of recognized as an asset and operating lease liabilities (Details) | Jun. 30, 2024 |
Leases | |
Weighted average remaining lease term - operating leases, in years | 3 years 6 months 7 days |
Weighted average discount rate - operating leases | 9.44% |
Leases - Schedule of future min
Leases - Schedule of future minimum rental payments, exclusive of taxes, insurance and other costs, under the leases (Details) $ in Thousands | Jun. 30, 2024 USD ($) |
Operating Lease Maturity | |
2024 (remaining six months) | $ 301 |
2025 | 339 |
2026 | 464 |
2027 | 476 |
2028 | 159 |
Total future minimum lease payments | 1,739 |
Imputed interest | (287) |
Total liability | $ 1,452 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Sep. 12, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Related Party Transaction | |||||
Gain on related party exchange | $ (23,000) | $ (31,000) | $ (68,000) | $ (17,000) | |
Motus GI Investments | |||||
Related Party Transaction | |||||
Shares acquired in termination of royalty certificates. | 701,522 | ||||
Gain on related party exchange | $ 349,000 |
Debt Financing - Other (Details
Debt Financing - Other (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||
Oct. 06, 2023 USD ($) $ / shares shares | Jun. 30, 2022 USD ($) tranche $ / shares shares | Jun. 30, 2024 USD ($) $ / shares shares | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) $ / shares shares | Jun. 30, 2023 USD ($) | Dec. 31, 2023 USD ($) shares | Jan. 26, 2023 USD ($) | Dec. 31, 2022 USD ($) | |
Debt Financing | |||||||||
Loss on extinguishment | $ (1,200,000) | ||||||||
Interest expense | $ 0 | $ 457,000 | $ 0 | $ 897,000 | |||||
Exercise Price | $ / shares | $ 11.50 | $ 11.50 | |||||||
Warrant liability, Fair value | $ 2,400,000 | $ 2,100,000 | |||||||
Fund I and II warrants | |||||||||
Debt Financing | |||||||||
Opportunities Fund I and II warrants | $ 100,000 | ||||||||
Estimated fair value of the warrants | 178,000 | ||||||||
Other financing cost | 405,000 | ||||||||
Avenue Warrants | |||||||||
Debt Financing | |||||||||
Warrants outstanding (in shares) | shares | 27,707 | 27,707 | 27,707 | ||||||
Exercise Price | $ / shares | $ 7.67 | $ 7.67 | $ 7.67 | ||||||
Cash payment with respect to certain fees | $ 212,500 | ||||||||
Amortization of Debt Discount (Premium) | $ 66,000 | ||||||||
Warrant liability, Fair value | 66,000 | ||||||||
2022 Loan and Security Agreement | |||||||||
Debt Financing | |||||||||
Term loan | $ 20,000,000 | ||||||||
Number of tranches | tranche | 2 | ||||||||
Outstanding principal amount of the loans converted into common stock | $ 5,000,000 | ||||||||
Conversion price | $ / shares | $ 12 | ||||||||
Conversion option not exercisable term | 6 months | ||||||||
Repayment terms of the loan | 4 years | ||||||||
Repayment of interest only term | 2 years | ||||||||
Repayment of principal | $ 417,000 | ||||||||
Repayment of principal and interest | $ 417,000 | ||||||||
Percentage of initial commitment amount | 4.25% | ||||||||
Initial commitment amount | $ 20,000,000 | ||||||||
2022 Loan and Security Agreement | Prime rate | |||||||||
Debt Financing | |||||||||
Interest rate variable (as a percent) | 6.45% | ||||||||
2022 Loan and Security Agreement | Fund I and II warrants | |||||||||
Debt Financing | |||||||||
Aggregate amount of debt repaid | 10,900,000 | ||||||||
Amount of principal repaid | $ 10,000,000 | ||||||||
Number of warrants issued | shares | 27,707 | ||||||||
Exercise Price | $ / shares | $ 7.67 | ||||||||
Net interest, prepayment fees and legal fees | $ 849,000 | ||||||||
Tranche One | |||||||||
Debt Financing | |||||||||
Term loan | $ 10,000,000 | ||||||||
Tranche Two | |||||||||
Debt Financing | |||||||||
Term loan | 10,000,000 | ||||||||
Tranche Three | |||||||||
Debt Financing | |||||||||
Term loan | 30,000,000 | ||||||||
2019 Loan and Security Agreement | |||||||||
Debt Financing | |||||||||
Estimated fair value of the warrants | $ 544,000 | ||||||||
Warrants outstanding (in shares) | shares | 0 | ||||||||
Loss on extinguishment | $ 682,000 | ||||||||
Percentage of amount drawn | 2% | ||||||||
Share price | $ / shares | $ 1.33 | ||||||||
Warrants Issued | $ 150,000 | ||||||||
Percentage of original aggregate principal amount | 8.25% | ||||||||
2019 Loan and Security Agreement | Maximum | |||||||||
Debt Financing | |||||||||
Interest rate stated (as a percent) | 6.25% | ||||||||
2019 Loan and Security Agreement | Prime rate | Maximum | |||||||||
Debt Financing | |||||||||
Interest rate variable (as a percent) | 1% |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of calculation of diluted net loss per share (Details) - shares | 6 Months Ended | |||
Apr. 12, 2023 | Jan. 26, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Anti-dilutive Securities | ||||
Earnout first milestone | 4,000,000 | |||
Earnout first milestone Round off | 3,999,987 | |||
Forfeitable shares | 500,000 | |||
Antidilutive securities | 14,086,296 | 10,754,634 | ||
Maximum | ||||
Anti-dilutive Securities | ||||
Shares consideration | 8,000,000 | |||
Earnout first milestone | 4,000,000 | |||
Employee Stock Option | ||||
Anti-dilutive Securities | ||||
Antidilutive securities | 5,164,962 | 3,821,922 | ||
Warrants | ||||
Anti-dilutive Securities | ||||
Antidilutive securities | 1,945,548 | 1,966,808 | ||
Restricted Stock | ||||
Anti-dilutive Securities | ||||
Antidilutive securities | 2,475,786 | 49,237 | ||
Conversion Option | ||||
Anti-dilutive Securities | ||||
Antidilutive securities | 416,667 | |||
Forfeitable Shares | ||||
Anti-dilutive Securities | ||||
Antidilutive securities | 500,000 | 500,000 | ||
Earnout Consideration | ||||
Anti-dilutive Securities | ||||
Antidilutive securities | 4,000,000 | 4,000,000 |
Subsequent Events (Details)
Subsequent Events (Details) - Open Market Sale Agreement - USD ($) $ in Millions | 6 Months Ended | |
Jul. 11, 2024 | Jun. 30, 2024 | |
Subsequent Events | ||
Shares issued (in shares) | 0 | |
Subsequent Events | ||
Subsequent Events | ||
Shares issued (in shares) | 2,000,000 | |
Aggregate gross proceeds from common stock | $ 15.5 | |
Net proceeds from common stock | $ 15 |