Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 | Delaware | 92-2038755 | | --- | --- | | (State or other jurisdiction of | (IRS Employer | | incorporation or organization) | Identification No.) | | 150 Union Square Drive | | | New Hope, Pennsylvania 18938 | | | (Address of principal executive offices, including zip co ...

PART I. FINANCIAL INFORMATION [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) Orchestra BioMed's unaudited condensed consolidated financial statements as of September 30, 2023, detail financial position and performance post-business combination [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to **$116.4 million** by September 30, 2023, driven by marketable securities, while liabilities decreased and equity significantly rose due to the business combination Condensed Consolidated Balance Sheet Summary (in thousands) | Account | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $19,078 | $19,784 | | Marketable securities | $89,410 | $63,915 | | Total current assets | $110,189 | $84,690 | | **Total Assets** | **$116,357** | **$95,572** | | **Liabilities & Equity** | | | | Total current liabilities | $21,473 | $18,566 | | Total Liabilities | $36,701 | $43,038 | | Total Stockholders' Equity | $79,656 | $52,534 | | **Total Liabilities & Stockholders' Equity** | **$116,357** | **$95,572** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss for the nine months ended September 30, 2023, increased to **$36.3 million**, primarily due to significant rises in R&D and SG&A expenses Statement of Operations Summary (in thousands) | Metric | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Total Revenue | $2,498 | $2,430 | | Research and development | $25,311 | $14,402 | | Selling, general and administrative | $16,073 | $10,699 | | Loss from operations | $(39,025) | $(22,829) | | **Net loss** | **$(36,302)** | **$(23,858)** | | **Net loss per share (basic and diluted)** | **$(1.11)** | **$(1.80)** | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities totaled **$35.2 million** for the nine months ended September 30, 2023, offset by **$56.9 million** from financing activities Cash Flow Summary (in thousands) | Activity | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(35,153) | $(20,545) | | Net cash used in investing activities | $(22,464) | $(745) | | Net cash provided by financing activities | $56,911 | $108,347 | | **Net (decrease) increase in cash** | **$(706)** | **$87,057** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes detail accounting policies, the HSAC2 business combination, key partnership agreements with Terumo and Medtronic, debt repayment, and stock-based compensation - The company is a biomedical innovation firm with lead products BackBeat CNT and Virtue SAB, operating a partnership-enabled business model with Medtronic and Terumo[23](index=23&type=chunk) - The company completed its business combination with HSAC2 on January 26, 2023, accounted for as a reverse recapitalization, yielding **$54.3 million** in net proceeds[24](index=24&type=chunk)[106](index=106&type=chunk) - Under the Terumo Agreement, a **$30 million** upfront payment was received in 2019, with revenue recognized proportionally based on costs; **$17.5 million** remains as deferred revenue as of September 30, 2023[107](index=107&type=chunk)[112](index=112&type=chunk)[114](index=114&type=chunk) - The Medtronic Agreement for BackBeat CNT involves Orchestra sponsoring the pivotal study and Medtronic commercializing the product globally post-approval, with no revenue recognized to date[119](index=119&type=chunk)[120](index=120&type=chunk)[121](index=121&type=chunk) - Subsequent to quarter end, on October 6, 2023, the company fully repaid its 2022 Loan and Security Agreement, including **$10 million** in principal[195](index=195&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=61&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition and results, detailing the impact of the January 2023 business combination, clinical program advancements, and liquidity, projecting funding into the second half of 2026 [Results of Operations](index=71&type=section&id=Results%20of%20Operations) Net loss increased significantly for both three and nine-month periods ended September 30, 2023, primarily due to substantial increases in R&D and SG&A expenses Comparison of Nine Months Ended Sep 30, 2023 and 2022 (in thousands) | Metric | 2023 | 2022 | Change $ | Change % | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $2,498 | $2,430 | $68 | 3% | | Research and development | $25,311 | $14,402 | $10,909 | 76% | | Selling, general and administrative | $16,073 | $10,699 | $5,374 | 50% | | **Net loss** | **$(36,302)** | **$(23,858)** | **$(12,444)** | **(52)%** | Comparison of Three Months Ended Sep 30, 2023 and 2022 (in thousands) | Metric | 2023 | 2022 | Change $ | Change % | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $419 | $1,163 | $(744) | (64)% | | Research and development | $8,558 | $5,899 | $2,659 | 45% | | Selling, general and administrative | $6,344 | $5,275 | $1,069 | 20% | | **Net loss** | **$(13,316)** | **$(10,282)** | **$(3,034)** | **(30)%** | [Liquidity and Capital Resources](index=79&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2023, the company held **$19.1 million** in cash and **$89.4 million** in marketable securities, projecting sufficient capital to fund operations into the second half of 2026 - The company had **$19.1 million** in cash and cash equivalents and **$89.4 million** in marketable securities as of September 30, 2023[267](index=267&type=chunk) - Based on revised operating priorities, current capital is anticipated to fund operations into the second half of 2026[270](index=270&type=chunk) - The Virtue ISR-US pivotal study is delayed pending a restructured partnership with Terumo to secure additional capital[268](index=268&type=chunk) [Critical Accounting Policies and Estimates](index=83&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Critical accounting policies include revenue recognition for the Terumo partnership, R&D accruals, warrant valuation, and stock-based compensation, all requiring significant management judgment - Partnership revenue from the Terumo Agreement is recognized using a proportional performance model, where changes in cost estimates can significantly impact reported revenue[293](index=293&type=chunk)[294](index=294&type=chunk) - Stock-based compensation is a critical estimate, with fair value determined by complex private company valuations pre-merger and public market price post-merger[301](index=301&type=chunk)[302](index=302&type=chunk)[303](index=303&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=93&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable for the current reporting period - Not applicable[316](index=316&type=chunk) [Controls and Procedures](index=93&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of September 30, 2023, with ongoing enhancements post-business combination - The CEO and CFO concluded the company's disclosure controls and procedures were effective as of September 30, 2023[320](index=320&type=chunk)[321](index=321&type=chunk) - The company is enhancing its internal control environment by adding accounting resources and implementing new processes as a public company[322](index=322&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=96&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings or aware of any pending actions - The company reports no material legal proceedings[326](index=326&type=chunk) [Risk Factors](index=96&type=section&id=Item%201A.%20Risk%20Factors) Material risks include missed milestone payments and potential termination of the Terumo partnership, impacting Virtue SAB development and requiring renegotiation for capital - The company has missed target dates for two **$5 million** milestone payments from Terumo and is unlikely to earn an additional **$25 million** in time-based milestones[328](index=328&type=chunk) - Failure to achieve milestones could lead Terumo to terminate the agreement, adversely impacting Virtue SAB product development and commercialization[329](index=329&type=chunk) - Negotiations with Terumo are ongoing to restructure the agreement for additional capital, with the Virtue SAB pivotal study on hold pending outcomes[330](index=330&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=97&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period - None[331](index=331&type=chunk) [Other Information](index=97&type=section&id=Item%205.%20Other%20Information) Director Geoffrey Smith resigned on November 9, 2023, and no Rule 10b5-1 trading plans were adopted or terminated during the quarter - Director Geoffrey Smith resigned from the Board and its committees on November 9, 2023[334](index=334&type=chunk)

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements, detailing the company's financial position, operational results, and cash flows as of June 30, 2023 [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet reflects a significant increase in total assets and stockholders' equity as of June 30, 2023, primarily driven by marketable securities and proceeds from the business combination Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $16,409 | $19,784 | | Marketable securities | $101,295 | $63,915 | | Total current assets | $119,590 | $84,690 | | **Total Assets** | **$125,883** | **$95,572** | | **Liabilities & Equity** | | | | Total current liabilities | $11,860 | $18,566 | | Warrant liability | $0 | $2,089 | | **Total Liabilities** | **$36,444** | **$43,038** | | **Total Stockholders' Equity** | **$89,439** | **$52,534** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The statement of operations shows increased revenue offset by a sharp rise in operating expenses, leading to a higher net loss for the six months ended June 30, 2023 Statement of Operations Summary (in thousands, except per share data) | Metric | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Total revenue | $2,079 | $1,267 | | Research and development | $16,753 | $8,503 | | Selling, general and administrative | $9,729 | $5,424 | | Loss from operations | $(24,501) | $(12,762) | | **Net loss** | **$(22,986)** | **$(13,576)** | | Net loss per share, basic and diluted | $(0.74) | $(0.74) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flow analysis indicates increased cash usage in operations and investing, largely offset by significant cash provided by financing activities for the six months ended June 30, 2023 Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(24,871) | $(13,289) | | Net cash used in investing activities | $(35,411) | $(521) | | Net cash provided by financing activities | $56,907 | $110,845 | | **Net (decrease) increase in cash** | **$(3,375)** | **$97,035** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section details the company's accounting policies, significant financial items, partnership agreements, debt financing, and subsequent events, including FDA approval for a pivotal study - The company is a biomedical innovation firm with flagship products BackBeat CNT (for hypertension) and Virtue SAB (for artery disease)[23](index=23&type=chunk) - On January 26, 2023, the company completed its business combination with HSAC2, becoming a publicly traded entity. The transaction is accounted for as a reverse recapitalization, with Legacy Orchestra as the accounting acquirer[24](index=24&type=chunk)[34](index=34&type=chunk)[87](index=87&type=chunk) - The Terumo Agreement for Virtue SAB involves an upfront payment of **$30 million**, recognized over time, and potential future milestones and royalties. The company notes that it is unlikely to meet certain time-based milestones[100](index=100&type=chunk) - The Medtronic Agreement for BackBeat CNT grants Medtronic exclusive commercialization rights post-approval, with Orchestra BioMed receiving payments based on sales. No revenue has been recognized under this agreement as of June 30, 2023[108](index=108&type=chunk)[109](index=109&type=chunk)[116](index=116&type=chunk) - The company has a **$10 million** term loan outstanding from a June 2022 agreement, maturing in **June 2026** with a floating interest rate of prime plus **6.45%** (**14.7%** at June 30, 2023)[168](index=168&type=chunk)[170](index=170&type=chunk) - Subsequent to the quarter end, on August 8, 2023, the FDA granted investigational device exemption (IDE) approval with conditions to initiate the Virtue ISR-US pivotal study[180](index=180&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=62&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the financial performance for the six months ended June 30, 2023, highlighting revenue growth, increased operating expenses, strong liquidity, and key risks related to partnership milestones [Results of Operations](index=69&type=section&id=Results%20of%20Operations) Operational results for the six months ended June 30, 2023, show increased partnership revenue, significantly higher R&D and SG&A expenses, and a resulting larger operating loss Comparison of Results for the Six Months Ended June 30 (in thousands) | Line Item | 2023 | 2022 | Change $ | Change % | | :--- | :--- | :--- | :--- | :--- | | Partnership revenue | $1,747 | $945 | $802 | 85% | | Research and development | $16,753 | $8,503 | $8,250 | 97% | | Selling, general and administrative | $9,729 | $5,424 | $4,305 | 79% | | Loss from operations | $(24,501) | $(12,762) | $(11,739) | (92)% | | Net loss | $(22,986) | $(13,576) | $(9,410) | (69)% | - The increase in R&D expenses was primarily due to a **$3.2 million** increase in personnel costs, a **$2.7 million** increase in program costs and supplies, and a **$1.3 million** increase in clinical development costs to advance BackBeat CNT and Virtue SAB[214](index=214&type=chunk) - The increase in SG&A expenses was mainly due to a **$2.0 million** increase in stock-based compensation and a **$1.3 million** increase in professional fees related to being a public company[216](index=216&type=chunk) [Liquidity and Capital Resources](index=77&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity position as of June 30, 2023, is strong, with sufficient cash and marketable securities to fund operations into 2026, supported by recent financing activities - The company has funded operations through convertible preferred stock (**$166.8M** cumulative), the Business Combination (**$70.0M** gross proceeds), and the Terumo Agreement (**$30.0M**)[236](index=236&type=chunk) - As of June 30, 2023, the company held **$16.4 million** in cash and cash equivalents and **$101.3 million** in short-term marketable securities[236](index=236&type=chunk) - Management believes current cash and marketable securities are sufficient to fund operations **into 2026**[238](index=238&type=chunk) [Critical Accounting Policies and Estimates](index=81&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section outlines the company's critical accounting policies and estimates, focusing on revenue recognition, research and development expenses, and stock-based compensation, which involve significant judgment - Partnership revenue from the Terumo agreement is recognized over time using a proportional performance model based on costs incurred relative to total expected costs. This requires significant estimation[264](index=264&type=chunk) - Estimates for total costs under the Terumo agreement were updated in Q2 2023, resulting in a **$303,000** reduction in partnership revenue for the six-month period compared to previous estimates[265](index=265&type=chunk) - Stock-based compensation expense for the six months ended June 30, 2023 was **$3.2 million**. As of June 30, 2023, there was approximately **$6.6 million** of total unrecognized stock-based compensation[279](index=279&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=91&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section addresses the company's exposure to market risks, which is currently deemed not applicable - Not applicable[287](index=287&type=chunk) [Controls and Procedures](index=91&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2023, with enhancements implemented post-business combination - Management concluded that disclosure controls and procedures were **effective as of June 30, 2023**[291](index=291&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, internal controls, other than enhancements made as a result of becoming a public company[292](index=292&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=94&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings or aware of any pending actions that would significantly impact its business - The company is not currently a party to any material legal proceedings[297](index=297&type=chunk) [Risk Factors](index=94&type=section&id=Item%201A.%20Risk%20Factors) A primary risk factor involves the company's strategic partnership with Terumo, specifically the failure to meet time-based milestone payments, which could adversely affect the agreement and financial results - A key risk is the failure to meet target achievement dates for milestone payments under the Terumo agreement[299](index=299&type=chunk) - The company has already passed the target dates for **two $5 million** milestone payments without achieving them and is unlikely to meet the remaining **$25 million** in time-based milestones[299](index=299&type=chunk) - Terumo has the right to terminate the agreement if certain milestones are not achieved, which would adversely impact development and commercialization plans for Virtue SAB[300](index=300&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=95&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section confirms there were no unregistered sales of equity securities during the reporting period - None[302](index=302&type=chunk) [Other Information](index=95&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during the three months ended June 30, 2023 - No director or officer adopted or terminated a Rule 10b5-1 trading arrangement during the quarter[305](index=305&type=chunk) [Exhibits](index=96&type=section&id=Item%206.%20Exhibits) This section provides a comprehensive list of exhibits filed with the Form 10-Q, including corporate governance documents, agreements, and required certifications

Financial Performance - The net losses for the three months ended March 31, 2023, and 2022 were $10.9 million and $5.7 million, respectively, with an accumulated deficit of $210.7 million as of March 31, 2023[191]. - Total revenue for the three months ended March 31, 2023, was $1.164 million, a 34% increase from $866,000 in the same period of 2022[213]. - Partnership revenue increased by $303,000, or approximately 42%, to $1.0 million in Q1 2023 from $716,000 in Q1 2022[214]. - Net loss for the three months ended March 31, 2023, was $10.9 million, compared to a net loss of $5.7 million in the same period of 2022, representing a 91% increase in losses[227]. - Cash and cash equivalents as of March 31, 2023, were $18.7 million, with an additional $108.4 million in short-term marketable securities[227]. - Net cash used in operating activities for Q1 2023 was $14.4 million, compared to $5.3 million in Q1 2022, indicating a significant increase in cash outflow[232]. - Net cash used in investing activities for Q1 2023 was $43.5 million, primarily for marketable securities[234]. - Net cash provided by financing activities for Q1 2023 was $56.8 million, attributed to net proceeds from the Business Combination[235]. Agreements and Partnerships - The company raised a cumulative $166.8 million through the issuance of convertible preferred stock and $70.0 million from the business combination, with an additional $30.0 million received from the Terumo Agreement as of March 31, 2023[191]. - The company has recognized $11.5 million in cumulative partnership revenues from the Terumo Agreement from 2019 through March 31, 2023[199]. - Under the Terumo Agreement, the company is eligible for milestone payments totaling $65 million, with $35 million related to achieving specific milestones by target dates[198]. - The company entered into the Medtronic Agreement in June 2022 for the development and commercialization of BackBeat CNT, with no revenue recognized under this agreement as of March 31, 2023[200]. - Partnership revenues related to the Terumo Agreement may include milestone payments and royalties, with an increase in partnership revenues of $81,000 in Q1 2023[252]. - The Terumo Agreement includes development and regulatory milestone payments, evaluated for probability of achievement at each reporting period[249]. Expenses - Research and development expenses are expected to increase in absolute dollars as the company continues to develop new products and enhance existing technologies[205]. - Selling, general and administrative expenses are anticipated to rise as the company incurs additional costs associated with operating as a public entity[206]. - Research and development expenses rose by $4.8 million, or approximately 138%, to $8.3 million in Q1 2023, primarily due to increased support for ongoing projects[220]. - Selling, general and administrative expenses increased by $1.9 million, or approximately 78%, to $4.4 million in Q1 2023, driven by higher headcount and associated costs[222]. Stock-Based Compensation - Stock-based compensation is measured at fair value using the Black-Scholes option-pricing model, with expenses recognized over the vesting period[258]. - Stock-based compensation for Q1 2023 was $1.5 million, a significant increase from $70,000 in Q1 2022[265]. - As of March 31, 2023, the company had approximately $11.2 million of total unrecognized stock-based compensation, expected to be recognized over a weighted-average period of approximately 3 years[265]. - The fair value of stock options is estimated based on various factors, including market conditions and company performance[260]. - The expected term for stock-based awards is determined using the "simplified" method, which is the midpoint between the vesting date and the contractual life of the awards[264]. - The expected volatility for stock-based awards is derived from historical stock volatilities of comparable peer public companies[264]. - Stock-based compensation increased significantly, indicating a potential focus on employee incentives and retention strategies[265]. Company Classification and Market Activity - The company remains classified as an "emerging growth company" and will maintain this status until it meets certain revenue or market capitalization thresholds[269]. - The company is also classified as a "smaller reporting company," allowing it to take advantage of scaled disclosures as long as its market value remains below $250 million or annual revenue is below $100 million[270]. - The company’s common stock began trading on The Nasdaq Global Market under the symbol "OBIO" on January 27, 2023, following the business combination[188]. - The expected dividend yield is zero, with no dividends anticipated in the foreseeable future[264]. - The fair value of the company's common stock is determined based on the closing price around the date of grant following the business combination[264]. Other Financial Information - The business combination was accounted for as a reverse recapitalization, treating Legacy Orchestra as the acquirer for financial reporting purposes[189]. - Total contractual obligations as of March 31, 2023, amounted to $16.58 million, with $1.72 million due within one year[238]. - The loss on fair value adjustment of warrant liability was $294,000 for Q1 2023, compared to a loss of $145,000 in Q1 2022, reflecting changes in the fair value of outstanding warrants[225]. - Research and development costs are estimated and accrued based on discussions with service providers regarding the progress of clinical studies[255]. - The estimated total costs associated with the Terumo Agreement decreased by approximately 0.7% as of March 31, 2023, compared to estimates from December 31, 2022[215].

Corporate Presentation Q1 2023 2 This presentation has been prepared for informational purposes only from information supplied by Orchestra BioMed Holdings, Inc., referred to herein as "we," "our," "Orchestra BioMed," and "the Company," and from third-party sources indicated herein. Such third-party information has not been independently verified. Orchestra BioMed makes no representation or warranty, expressed or implied, as to the accuracy or completeness of such information. This presentation contains for ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to ________________ Commission file number: 001-39421 HEALTH SCIENCES ACQUISITIONS CORPORATION 2 (Exact name of registrant as specified in its charter) | Cayman ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q 40 10 Avenue, Floor 7 New York, New York 10014 (Address of Principal Executive Offices) (Zip Code) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ HEALTH SCIENCES ACQUISITIONS CORPORATION 2 ...

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) This section presents the unaudited interim financial statements, including balance sheets, statements of operations, changes in shareholders' deficit, and cash flows, along with notes detailing the SPAC's nature, proposed merger, and going concern uncertainty [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (as of June 30, 2022 vs. Dec 31, 2021) | Account | June 30, 2022 (Unaudited) | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $1,306,702 | $1,754,460 | | Investments held in Trust Account | $160,239,964 | $160,022,447 | | **Total Assets** | **$161,583,083** | **$161,823,574** | | **Liabilities & Equity** | | | | Total current liabilities | $1,097,658 | $165,539 | | Deferred underwriting commissions | $5,600,000 | $5,600,000 | | Ordinary shares subject to possible redemption | $160,139,964 | $160,000,000 | | Total shareholders' deficit | ($5,254,539) | ($3,941,965) | [Unaudited Condensed Consolidated Statements of Operations](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) Statements of Operations Summary | Period | General & Admin Expenses | Interest Income (Trust) | Net Loss | Basic and Diluted Net Loss per Share | | :--- | :--- | :--- | :--- | :--- | | **Three Months Ended June 30, 2022** | $908,173 | $203,252 | ($734,921) | ($0.04) | | **Three Months Ended June 30, 2021** | $66,318 | $3,989 | ($92,329) | ($0.00) | | **Six Months Ended June 30, 2022** | $1,330,127 | $217,517 | ($1,172,610) | ($0.06) | | **Six Months Ended June 30, 2021** | $148,266 | $7,935 | ($200,331) | ($0.01) | [Unaudited Condensed Consolidated Statements of Changes in Shareholders' Deficit](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders'%20Deficit) - The total shareholders' deficit increased from approximately **$3.94 million** at the end of 2021 to approximately **$5.25 million** as of June 30, 2022, primarily driven by the net loss for the period and an increase in the redemption value of ordinary shares subject to possible redemption[14](index=14&type=chunk) [Unaudited Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary (Six Months Ended June 30) | Metric | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($447,758) | ($115,517) | | Cash - beginning of the period | $1,754,460 | $2,026,822 | | Cash - end of the period | $1,306,702 | $1,911,305 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes provide critical context, detailing the company's formation as a SPAC targeting the healthcare innovation sector, its IPO and private placement financing, and the terms of its Trust Account, along with the proposed merger with Orchestra BioMed and a going concern uncertainty due to the impending business combination deadline - The Company is a Cayman Islands exempted company formed on May 25, 2020, for the purpose of a business combination, with an intent to focus on healthcare innovation targets[18](index=18&type=chunk) - On August 6, 2020, the Company completed its Initial Public Offering (IPO) of **16,000,000 ordinary shares** at **$10.00 per share**, raising gross proceeds of **$160.0 million**, with a simultaneous private placement raising an additional **$6.0 million**[20](index=20&type=chunk)[21](index=21&type=chunk) - Management has determined that the mandatory liquidation and subsequent dissolution required if a Business Combination is not consummated by the deadline (**February 6, 2023**) raises substantial doubt about the Company's ability to continue as a going concern[32](index=32&type=chunk) - On July 4, 2022, the Company entered into a merger agreement with Orchestra BioMed, Inc., involving the Company domesticating as a Delaware corporation and Orchestra BioMed becoming a wholly-owned subsidiary[79](index=79&type=chunk) - In connection with the proposed merger, the Company secured approximately **$20.0 million** in Forward Purchase Agreements and a backstop agreement to ensure a minimum of **$60 million** in cash at closing[81](index=81&type=chunk)[82](index=82&type=chunk) - On July 26, 2022, shareholders approved extending the business combination deadline from **August 6, 2022**, to potentially as late as **February 6, 2023**, leading to the redemption of **9,237,883 public shares** (approx. **57.7%**), reducing the trust account balance to approximately **$67.8 million**[86](index=86&type=chunk)[87](index=87&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and results, noting no operating revenue, net losses from administrative expenses, and the proposed merger with Orchestra BioMed, while addressing liquidity and going concern risks - The company is a blank check company formed to effect a business combination, with an intention to target the healthcare innovation sector, and has not generated any operating revenue to date[92](index=92&type=chunk)[113](index=113&type=chunk) Results of Operations (Net Loss) | Period | Net Loss | Key Drivers | | :--- | :--- | :--- | | **Three Months Ended June 30, 2022** | ~$735,000 | ~$938,000 in operating expenses, offset by ~$203,000 in interest income | | **Six Months Ended June 30, 2022** | ~$1.1 million | ~$1.39 million in operating expenses, offset by ~$217,000 in interest income | - The company entered into a definitive merger agreement with Orchestra BioMed, Inc. on July 4, 2022, with the transaction supported by forward purchase and backstop agreements to ensure funding[98](index=98&type=chunk)[99](index=99&type=chunk)[100](index=100&type=chunk) - Shareholders approved an extension of the combination period to **February 6, 2023**, which led to the redemption of approximately **57.7%** of public shares, reducing the trust account to about **$67.8 million**[104](index=104&type=chunk)[105](index=105&type=chunk) - As of June 30, 2022, the company had approximately **$1.3 million** in cash and **$245,000** in working capital, which management believes is sufficient for near-term needs, but the mandatory liquidation requirement raises substantial doubt about its ability to continue as a going concern[108](index=108&type=chunk)[110](index=110&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company and is not required to provide the information for this item - As a smaller reporting company, as defined by Rule 12b-2 of the Exchange Act, the company is not required to provide quantitative and qualitative disclosures about market risk[138](index=138&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of June 30, 2022, with a material weakness identified in fiscal year 2021 fully remediated during the quarter - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of June 30, 2022[139](index=139&type=chunk) - A material weakness in internal control over financial reporting that was previously identified in fiscal year 2021 was fully remediated as of June 30, 2022[141](index=141&type=chunk)[143](index=143&type=chunk) [PART II. OTHER INFORMATION](index=33&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no legal proceedings - There are no legal proceedings to report[145](index=145&type=chunk) [Item 1A. Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) As a smaller reporting company, the company is not required to provide this information - The company is a smaller reporting company and is not required to provide the information otherwise required under this item[146](index=146&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=33&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities or use of proceeds for the period - None reported[147](index=147&type=chunk) [Item 3. Defaults Upon Senior Securities](index=33&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None reported[148](index=148&type=chunk) [Item 4. Mine Safety Disclosures](index=33&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[149](index=149&type=chunk) [Item 5. Other Information](index=33&type=section&id=Item%205.%20Other%20Information) The company reports no other information - None reported[150](index=150&type=chunk) [Item 6. Exhibits](index=34&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including CEO and CFO certifications and XBRL data files - The report includes a list of exhibits filed, such as officer certifications (31.1, 31.2, 32.1, 32.2) and Inline XBRL documents[152](index=152&type=chunk)

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The financial statements reflect Health Sciences Acquisitions Corporation 2's pre-business combination status, holding approximately $160 million in a trust account with a net loss of $437,689 for Q1 2022 [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2022, total assets were $161.5 million, primarily investments in the Trust Account, with total liabilities of $5.9 million and a shareholders' deficit of approximately $4.4 million Balance Sheet Highlights | Balance Sheet Highlights | March 31, 2022 (Unaudited) | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $1,418,880 | $1,754,460 | | Investments held in Trust Account | $160,036,712 | $160,022,447 | | **Total Assets** | **$161,526,884** | **$161,823,574** | | **Liabilities & Equity** | | | | Total current liabilities | $306,538 | $165,539 | | Deferred underwriting commissions | $5,600,000 | $5,600,000 | | **Total Liabilities** | **$5,906,538** | **$5,765,539** | | Ordinary shares subject to possible redemption | $160,000,000 | $160,000,000 | | **Total shareholders' deficit** | **($4,379,654)** | **($3,941,965)** | [Unaudited Condensed Statements of Operations](index=5&type=section&id=Unaudited%20Condensed%20Statements%20of%20Operations) For the three months ended March 31, 2022, the company reported a net loss of $437,689, or ($0.02) per share, driven by increased general and administrative expenses Statement of Operations | Statement of Operations | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | General and administrative expenses | $421,954 | $81,948 | | Administrative fee - related party | $30,000 | $30,000 | | Loss from operations | ($451,954) | ($111,948) | | Interest income from investments held in Trust Account | $14,265 | $3,946 | | **Net loss** | **($437,689)** | **($108,002)** | | **Basic and diluted net loss per ordinary share** | **($0.02)** | **($0.01)** | [Unaudited Condensed Statements of Changes in Shareholders' Deficit](index=6&type=section&id=Unaudited%20Condensed%20Statements%20of%20Changes%20in%20Shareholders'%20Deficit) The company's shareholders' deficit increased from approximately $3.94 million at the end of 2021 to $4.38 million as of March 31, 2022, solely due to the net loss incurred - The total shareholders' deficit increased from **($3,941,965)** at December 31, 2021, to **($4,379,654)** at March 31, 2022, with the change being solely due to the net loss of **($437,689)** for the quarter[15](index=15&type=chunk) [Unaudited Condensed Statements of Cash Flows](index=7&type=section&id=Unaudited%20Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly increased to $335,580 for the three months ended March 31, 2022, reducing the cash balance to $1.42 million Cash Flow Data | Cash Flow Data | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net loss | ($437,689) | ($108,002) | | **Net cash used in operating activities** | **($335,580)** | **($76,374)** | | Net change in cash | ($335,580) | ($76,374) | | Cash - beginning of the period | $1,754,460 | $2,026,822 | | **Cash - end of the period** | **$1,418,880** | **$1,950,448** | [Notes to Unaudited Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) The notes detail the company's nature as a SPAC, its August 6, 2022 business combination deadline raising going concern doubts, and commitments like deferred underwriting commissions - The company is a SPAC incorporated on May 25, 2020, to effect a business combination, intending to target the healthcare innovation sector, with all activity to date related to its formation, IPO, and search for a target[23](index=23&type=chunk)[24](index=24&type=chunk) - The company must consummate a Business Combination by **August 6, 2022**, and this mandatory liquidation deadline raises substantial doubt about its ability to continue as a going concern[34](index=34&type=chunk)[39](index=39&type=chunk) - The company has a deferred underwriting commission of **$5.6 million**, payable from the Trust Account only upon the completion of a Business Combination[75](index=75&type=chunk) - Related party transactions include a **$10,000 monthly fee** to the Sponsor for office space and services, and potential Working Capital Loans from affiliates to finance transaction costs[69](index=69&type=chunk)[70](index=70&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's status as a blank check company with a business combination deadline of August 6, 2022, and a Q1 2022 net loss of approximately $438,000 - The company is a blank check company with the purpose of entering into a business combination, with an intended focus on healthcare innovation[91](index=91&type=chunk) - The company has until **August 6, 2022**, to complete its initial Business Combination, with failure triggering automatic liquidation and dissolution[96](index=96&type=chunk) - As of March 31, 2022, the company had approximately **$1.4 million in cash** and **$1.2 million in working capital**, which management believes is sufficient to meet its needs through a Business Combination or one year from filing[97](index=97&type=chunk)[99](index=99&type=chunk) - Management has determined that the mandatory liquidation and subsequent dissolution by **August 6, 2022**, raises substantial doubt about the company's ability to continue as a going concern[99](index=99&type=chunk) Results of Operations | Results of Operations | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net Loss | ~$438,000 | ~$108,000 | | Key Drivers | General & administrative expenses, related party fees | General & administrative expenses, related party fees | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=22&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the registrant is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, the registrant is not required to provide quantitative and qualitative disclosures about market risk[122](index=122&type=chunk) [Item 4. Controls and Procedures](index=22&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were not effective as of March 31, 2022, due to a material weakness in accounting for complex financial instruments - The Chief Executive Officer and Chief Financial Officer concluded that disclosure controls and procedures were not effective as of March 31, 2022[123](index=123&type=chunk) - A material weakness was identified in internal control over financial reporting, specifically concerning the accounting for complex financial instruments, which led to the restatement of prior financial statements[124](index=124&type=chunk) - Management is taking steps to remediate the material weakness, including performing additional financial analyses and consulting with subject matter experts[127](index=127&type=chunk) [PART II. OTHER INFORMATION](index=23&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=23&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings - There are no legal proceedings to report[129](index=129&type=chunk) [Item 1A. Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) As a smaller reporting company, the company is not required to provide risk factor disclosures in this report - The company is a smaller reporting company and is not required to provide risk factor disclosures in this report[130](index=130&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=23&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds for the period - There were no unregistered sales of equity securities or use of proceeds to report[131](index=131&type=chunk) [Item 3. Defaults Upon Senior Securities](index=23&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - There were no defaults upon senior securities[132](index=132&type=chunk) [Item 4. Mine Safety Disclosures](index=23&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Mine safety disclosures are not applicable[133](index=133&type=chunk) [Item 5. Other Information](index=23&type=section&id=Item%205.%20Other%20Information) The company reported no other information - There is no other information to report[134](index=134&type=chunk) [Item 6. Exhibits](index=24&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including CEO and CFO certifications and Inline XBRL documents - The exhibits filed with this report include certifications from the CEO and CFO under Sections 302 and 906 of the Sarbanes-Oxley Act, as well as various Inline XBRL data files[136](index=136&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to ________________ Commission file number: 001-39421 HEALTH SCIENCES ACQUISITIONS CORPORATION 2 (Exact name of registrant as specified in its charter) | Cayman Islan ...