Orchestra BioMed Holdings, Inc. (OBIO) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices. The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate. The ...

Orchestra BioMed Holdings, Inc. (OBIO) closed the last trading session at $6.93, gaining 35.9% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $16.33 indicates a 135.6% upside potential. The average comprises three short-term price targets ranging from a low of $14 to a high of $20, with a standard deviation of $3.21. While the lowest estimate indicates an increase of 102% from the ...

Orchestra BioMed (NASDAQ:OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed's partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed's lead product candidate is atrioventricular interval modulation (AVIM) therapy (also known a ...

Orchestra BioMed Holdings, Inc. Shares have lost about 48.4% since the beginning of the year versus the S&P 500's gain of 9.5%. What's Next for Orchestra BioMed Holdings, Inc. Orchestra BioMed Holdings, Inc. (OBIO) came out with a quarterly loss of $0.38 per share versus the Zacks Consensus Estimate of a loss of $0.40. This compares to loss of $0.40 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 5%. A quarter ago, it was exp ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 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 ORCHESTRA BIOMED HOLDINGS, INC. (Exact name of registrant as specif ...

Patent estate covering atrioventricular interval modulation ("AVIM") therapy includes 37 issued U.S. patents and 73 patents outside the U.S. that collectively comprise over 1,800 claims related to the treatment of hypertensionAVIM therapy is currently being studied in the BACKBEAT global pivotal study in collaboration with MedtronicOrchestra BioMed to provide detailed overview of AVIM therapy and the BACKBEAT global pivotal study in upcoming R&D day on June 11, 2024 in New York City NEW HOPE, Pa., April 30, ...

NEW HOPE, Pa., April 30, 2024 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (NASDAQ:OBIO, "Orchestra BioMed" or the "Company"))), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced it will host an in-person R&D day at the Lotte New York Palace Hotel on Tuesday, June 11, 2024 at 10:00 AM ET. To register, click here. The event will feature presentations by company management and key opinion leaders related to the Company's lea ...

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