[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section provides the company's financial statements, management's analysis, market risk disclosures, and internal controls - The company's management concluded that available capital may not be sufficient to fund operations for the next year, raising substantial doubt about its ability to continue as a going concern[30](index=30&type=chunk)[31](index=31&type=chunk) [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) The company reported an increased net loss of **$18.8 million** for Q1 2025, holding **$49.8 million** in cash and marketable securities, with a going concern disclosure [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's condensed consolidated balance sheets as of March 31, 2025, and December 31, 2024 Condensed Consolidated Balance Sheet Highlights (Unaudited) | (in thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $18,348 | $22,261 | | Marketable securities | $31,536 | $44,551 | | Total current assets | $51,903 | $69,171 | | **Total Assets** | **$59,051** | **$76,173** | | **Liabilities & Equity** | | | | Total current liabilities | $15,489 | $16,207 | | Loan payable | $14,338 | $14,292 | | **Total Liabilities** | **$42,194** | **$43,215** | | Accumulated deficit | ($328,633) | ($309,878) | | **Total Stockholders' Equity** | **$16,857** | **$32,958** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2025 and 2024 Condensed Consolidated Statements of Operations (Unaudited) | (in thousands, except per share data) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Total revenue | $868 | $620 | | Research and development | $13,482 | $9,112 | | Selling, general and administrative | $6,263 | $5,897 | | Loss from operations | ($18,921) | ($14,423) | | **Net loss** | **($18,755)** | **($13,463)** | | **Net loss per share, basic and diluted** | **($0.49)** | **($0.38)** | [Condensed Consolidated Statements of Stockholders' Equity (Deficit)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Deficit)) This section outlines the changes in stockholders' equity for the three months ended March 31, 2025 - For the three months ended March 31, 2025, total stockholders' equity decreased from **$32.96 million** to **$16.86 million**, primarily due to a **$18.76 million** net loss, partially offset by **$2.97 million** in stock-based compensation[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section presents the company's condensed consolidated statements of cash flows for the three months ended March 31, 2025 and 2024 Condensed Consolidated Statements of Cash Flows Highlights (Unaudited) | (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($16,616) | ($13,114) | | Net cash provided by investing activities | $12,999 | $5,861 | | Net cash (used in) provided by financing activities | ($296) | $18 | | **Net decrease in cash and cash equivalents** | **($3,913)** | **($7,235)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed notes to the unaudited condensed consolidated financial statements, covering significant accounting policies and agreements - The company is a biomedical innovation firm with flagship products **AVIM therapy** (partnered with Medtronic) for hypertension and **Virtue SAB** (partnered with Terumo) for artery disease[22](index=22&type=chunk) - The company is in mediation with Terumo regarding potential adjustments to milestone payments, where an unfavorable outcome could adversely impact the **Virtue SAB** program[82](index=82&type=chunk) - Under the Medtronic Agreement, the company sponsors a pivotal study for **AVIM therapy**, with Medtronic holding exclusive global commercialization rights and the company receiving sales-based payments[92](index=92&type=chunk)[93](index=93&type=chunk) - In November 2024, the company secured a term loan facility of up to **$50.0 million** with Hercules Capital, drawing an initial **$15.0 million** tranche, subject to financial covenants including minimum cash requirements[140](index=140&type=chunk)[144](index=144&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=47&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management reported an increased net loss of **$18.8 million** for Q1 2025, driven by higher R&D expenses, with current liquidity of **$49.9 million** insufficient for the next 12 months, necessitating further funding efforts - The company received **FDA Breakthrough Device Designation** for its **AVIM therapy system** for hypertension, expediting development and priority review[165](index=165&type=chunk) - The company received FDA approval for an amended IDE to initiate the **Virtue Trial** for its **Virtue SAB** product, with enrollment targeted for the second half of 2025[166](index=166&type=chunk)[167](index=167&type=chunk) - The company's liquidity of **$49.9 million** as of March 31, 2025, is insufficient to fund operations for the next twelve months, raising substantial doubt about its ability to continue as a going concern[214](index=214&type=chunk) [Results of Operations](index=57&type=section&id=Results%20of%20Operations) Total revenue increased **40%** to **$0.87 million** in Q1 2025, while total operating expenses grew **32%** to **$19.8 million**, resulting in a **39%** higher net loss of **$18.8 million** Comparison of the Three Months Ended March 31, 2025 and 2024 (in thousands) | | 2025 | 2024 | Change $ | Change % | | :--- | :--- | :--- | :--- | :--- | | **Total revenue** | **$868** | **$620** | **$248** | **40%** | | Partnership revenue | $732 | $497 | $235 | 47% | | **Total expenses** | **$19,789** | **$15,043** | **$4,746** | **32%** | | Research and development | $13,482 | $9,112 | $4,370 | 48% | | Selling, general and administrative | $6,263 | $5,897 | $366 | 6% | | **Net loss** | **($18,755)** | **($13,463)** | **($5,292)** | **(39)%** | - R&D expenses increased by **$4.4 million (48%)** to **$13.5 million** in Q1 2025, primarily due to increased costs for the **BACKBEAT pivotal study** and advancing the **Virtue SAB** program[193](index=193&type=chunk) [Liquidity and Capital Resources](index=60&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company held **$49.9 million** in cash and marketable securities, but these resources are insufficient to fund operations for the next 12 months, necessitating additional capital raising efforts - The company has an active at-the-market (ATM) sales agreement with TD Cowen to sell up to **$100 million** of common stock, with the full amount available as of March 31, 2025[199](index=199&type=chunk) - The company has a secured term loan facility of up to **$50.0 million** with Hercules, with **$15.0 million** drawn and further tranches available upon achieving performance milestones[200](index=200&type=chunk) - Future funding requirements depend on clinical study costs and pace, potentially necessitating additional liquidity through new equity, further debt drawdowns, or other financing structures[209](index=209&type=chunk)[210](index=210&type=chunk) [Critical Accounting Policies and Estimates](index=66&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) The company's critical accounting policies involve significant judgment, particularly in revenue recognition for the Terumo partnership and the valuation of stock-based compensation using the Black-Scholes model - Revenue from the **Terumo Agreement** is recognized over time using a proportional performance model, requiring estimates of total costs to complete the performance obligation, currently projected for 2029[235](index=235&type=chunk) - The company estimates the fair value of stock option grants using the **Black-Scholes model**, with key assumptions including expected term, volatility, and risk-free interest rate[245](index=245&type=chunk) - As of March 31, 2025, the company had approximately **$15.5 million** of total unrecognized stock-based compensation, expected to be recognized over a weighted-average period of about **2.2 years**[246](index=246&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=76&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable for the reporting period [Controls and Procedures](index=76&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - The company's management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of March 31, 2025[257](index=257&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended March 31, 2025[258](index=258&type=chunk) [PART II. OTHER INFORMATION](index=78&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, defaults, mine safety, and other disclosures [Legal Proceedings](index=78&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings and is unaware of any pending or threatened legal actions that would materially affect its business - As of the report date, the company is not involved in any material legal proceedings[262](index=262&type=chunk) [Risk Factors](index=78&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors from the 2024 Form 10-K, except for a new risk concerning potential adverse effects from changes in trade policy and tariffs - A new risk factor was added regarding changes to trade policy, where tariffs and economic sanctions could adversely affect the company's business and financial condition[264](index=264&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=78&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - None reported for the period[265](index=265&type=chunk) [Defaults Upon Senior Securities](index=78&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the period - None reported for the period[266](index=266&type=chunk) [Mine Safety Disclosures](index=78&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company [Other Information](index=78&type=section&id=Item%205.%20Other%20Information) No director or officer adopted or terminated a Rule 10b5-1 trading arrangement during the three months ended March 31, 2025 - No directors or officers adopted or terminated a Rule 10b5-1 trading arrangement during the quarter[268](index=268&type=chunk) [Exhibits](index=80&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the Certificate of Incorporation, Bylaws, and certifications by the CEO and CFO

Core Insights - Orchestra BioMed is expanding its intellectual property portfolio, securing 10 new patents related to hypertension treatment, bringing the total to 120 patents in this area [2][6] - The company has also increased its patent estate for heart failure treatment to 17 issued patents, enhancing its overall IP platform [2][6] - AVIM therapy is currently being evaluated in the BACKBEAT global pivotal study for treating uncontrolled hypertension in patients indicated for pacemakers, highlighting its potential impact on broader cardiovascular health [2][8] Intellectual Property Expansion - The global intellectual property portfolio for AVIM therapy includes patent protection in key markets such as the United States, Europe, Japan, and China [3] - The hypertension-specific patent estate now consists of 46 issued U.S. patents and 91 patents outside the U.S., collectively comprising over 2100 claims related to hypertension and heart failure [6] Strategic Collaborations - Orchestra BioMed has a strategic collaboration with Medtronic for the development and commercialization of AVIM therapy, focusing on hypertension treatment in pacemaker-indicated patients [4] - The company is also partnered with Terumo for the development of the Virtue Sirolimus AngioInfusion™ Balloon for treating atherosclerotic artery disease [4] Regulatory Designations - AVIM therapy has received Breakthrough Device Designation from the U.S. FDA for treating uncontrolled hypertension with increased cardiovascular risk, which may expedite its development and market access [2][6][9]

Company Overview - Orchestra BioMed Holdings, Inc. (OBIO) is expected to report a quarterly loss of $0.46 per share, reflecting a year-over-year decline of 21.1% [3] - Revenues are anticipated to be $0.39 million, down 37.1% from the same quarter last year [3] Earnings Expectations - The consensus EPS estimate has been revised 1.03% lower in the last 30 days, indicating a reassessment by analysts [4] - The Most Accurate Estimate for OBIO is higher than the Zacks Consensus Estimate, resulting in a positive Earnings ESP of +1.64% [11] Earnings Surprise Prediction - A positive Earnings ESP reading suggests a higher likelihood of an earnings beat, especially when combined with a Zacks Rank of 1 (Strong Buy), 2 (Buy), or 3 (Hold) [8] - The company currently holds a Zacks Rank of 3, indicating a moderate expectation of beating the consensus EPS estimate [11] Historical Performance - In the last reported quarter, OBIO was expected to post a loss of $0.43 per share and met this expectation with no surprise [12] - Over the past four quarters, the company has beaten consensus EPS estimates two times [13] Industry Context - Intellia Therapeutics, Inc. (NTLA), a peer in the Zacks Medical - Biomedical and Genetics industry, is expected to report an EPS of $1.26, reflecting a year-over-year decline of 18.9% [17] - NTLA's revenues are projected to be $14.5 million, down 49.9% from the previous year [17] - Despite a recent upward revision of 0.8% in NTLA's EPS estimate, it has a negative Earnings ESP of -4.93%, complicating predictions for an earnings beat [18]

Summary of Orchestra BioMed Holdings (OBIO) Conference Call Company Overview - **Company**: Orchestra BioMed Holdings (OBIO) - **Focus**: Biomedical innovation company specializing in high-impact medical device therapies through strategic partnerships [2][3] Core Technologies - **AVIM Therapy Program**: - Treatment for hypertension delivered via an implantable pulse generator (pacemaker) [2][3] - Significant blood pressure reduction observed in clinical studies, with a 11 mmHg reduction in systolic blood pressure at six months [7][8] - No major adverse cardiac events reported in treatment group [9] - **Virtu's Sirolimus Angio Infusion Balloon**: - Combines drug and device for treating coronary and peripheral artery disease [3][32] - Recently received IDE approval for a pivotal head-to-head study against a competing product [32][36] Market Potential - Both programs target established multibillion-dollar markets with significant unmet needs [3] - AVIM therapy has a potential addressable patient population of approximately 8 million in the U.S. with uncontrolled hypertension [20][27] - Breakthrough designation for AVIM therapy could lead to additional reimbursement opportunities, with potential revenue share of up to $1,600 per device [30][31] Clinical Study Insights - **AVIM Therapy**: - Pivotal study design adjustments made to optimize patient evaluation and enrollment [10][14] - Collaboration with Medtronic enhances regulatory interactions and study execution [15][21] - **Virtu's SAB**: - Head-to-head study design allows for showcasing product advantages and regulatory approval probability [36][40] - Focus on delivering a higher drug payload compared to existing products [38][39] Regulatory Interactions - Positive interactions with the FDA noted, with timely approvals and thoughtful communication [43][45] - Breakthrough designation and IDE approval achieved on schedule, reflecting effective collaboration with regulatory bodies [47][48] Strategic Partnerships - Partnership with Medtronic is crucial for leveraging their market presence and regulatory expertise [21][22] - Collaboration enhances Orchestra's ability to navigate complex regulatory landscapes and optimize clinical trial designs [15][21] Conclusion - Orchestra BioMed is positioned to make significant advancements in hypertension and cardiovascular disease treatment through innovative therapies and strategic partnerships, with promising clinical data and regulatory support paving the way for future growth and market entry [23][47]

Core Viewpoint - Orchestra BioMed has received FDA approval for an Investigational Device Exemption amendment to initiate the Virtue Trial, which will compare its Sirolimus-AngioInfusion Balloon (Virtue SAB) against the Boston Scientific AGENT paclitaxel-coated balloon for treating coronary in-stent restenosis (ISR) [1][5][6] Company Overview - Orchestra BioMed is a biomedical innovation company focused on accelerating high-impact technologies through partnerships with leading medical device companies [9][10] - The company is developing the Virtue SAB for atherosclerotic artery disease, which is a leading cause of mortality worldwide [10] Product Differentiation - Virtue SAB utilizes a proprietary extended-release formulation of sirolimus (SirolimusEFR™) delivered through a non-coated microporous AngioInfusion™ Balloon, designed to overcome limitations of traditional drug-coated balloons (DCBs) [2][4][8] - The device has been granted multiple FDA Breakthrough Device Designations for various indications, including coronary ISR and small vessel disease [5][8] Clinical Trial Details - The Virtue Trial will be the first U.S. head-to-head randomized evaluation of a sirolimus-eluting balloon versus a commercially available paclitaxel-coated balloon for coronary ISR [5] - The trial aims to enroll 740 patients across up to 75 centers in the U.S., with a primary endpoint of non-inferiority in Target Lesion Failure (TLF) at 12 months [6][5] Market Potential - The U.S. market for coronary drug delivery balloons is estimated to be multibillion-dollar, driven by significant unmet clinical needs and established reimbursement [6] - The company believes that the superior safety and efficacy of sirolimus over paclitaxel will be demonstrated through the performance of Virtue SAB in clinical settings [6]

Core Insights - Orchestra BioMed Holdings, Inc. is actively participating in multiple institutional investor conferences to discuss its innovative biomedical technologies and partnerships [1][2][3] Group 1: Upcoming Conferences - The company will participate in Chardan Capital's Trending Issues in Drug Development Conference on April 29, 2025, featuring a fireside chat with CEO David Hochman [1] - Management will also engage in a live fireside chat at the Jefferies Global Healthcare Conference on June 5, 2025, along with one-on-one meetings with investors [2] - Additionally, a live presentation is scheduled for the H.C. Wainwright 3rd Annual BioConnect Investor Conference on May 20, 2025, where management will host one-on-one meetings [3] Group 2: Company Overview - Orchestra BioMed focuses on accelerating high-impact biomedical technologies through risk-reward sharing partnerships with leading medical device companies [4] - The company's lead product candidate is atrioventricular interval modulation (AVIM) therapy for hypertension, a major global health risk [4] - Orchestra BioMed is also developing the Virtue Sirolimus AngioInfusion™ Balloon for atherosclerotic artery disease, which is a leading cause of mortality worldwide [4] - The company has strategic collaborations with Medtronic for AVIM therapy and with Terumo for the Virtue SAB [4]

Core Insights - Orchestra BioMed Holdings, Inc. announced an industry-sponsored satellite symposium at the Heart Rhythm Society 2025 Annual Meeting to discuss advancements in its atrioventricular interval modulation (AVIM) therapy program [1][4] - The FDA granted Breakthrough Device Designation to AVIM therapy for treating hypertension in patients with increased cardiovascular risk, highlighting the unmet need in this patient population [2][4] - The BACKBEAT global pivotal study is currently enrolling patients to evaluate the efficacy of AVIM therapy in managing uncontrolled hypertension [2][9] Company Overview - Orchestra BioMed is a biomedical innovation company focused on accelerating high-impact technologies through partnerships with leading medical device companies [7] - The company's lead product candidate is AVIM therapy, aimed at treating hypertension, which is a leading risk factor for death globally [7] - Orchestra BioMed has strategic collaborations with Medtronic for AVIM therapy and Terumo for the Virtue Sirolimus AngioInfusion Balloon [7] Symposium Details - The symposium titled "The Future of Cardiac Pacing: Unlocking the Potential of Atrioventricular Interval Modulation (AVIM) Therapy" will take place on April 25, 2025, at the Hilton San Diego Bayfront Hotel [3] - Presentations will cover clinical results from studies demonstrating AVIM therapy's effectiveness in reducing blood pressure and improving cardiac function [4][5] - Key presentations will include topics on the unmet hypertension need, AVIM therapy's impact on hypertension, and the rationale behind the BACKBEAT study [5][6] Clinical Evidence - AVIM therapy has shown promising results in pilot studies, with reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure and 12.3 mmHg in office systolic blood pressure at six months compared to control patients [9] - The BACKBEAT study aims to further evaluate the safety and efficacy of AVIM therapy in patients with uncontrolled hypertension despite anti-hypertensive medication [9]

Core Insights - The U.S. FDA has granted Breakthrough Device Designation for Orchestra BioMed's AVIM therapy, which aims to manage hypertension in patients at high cardiovascular risk [1][3][6] Regulatory and Clinical Development - The Breakthrough Device Designation is specifically for an implantable system (pacemaker) that delivers AVIM therapy to reduce blood pressure in patients with increased ten-year ASCVD risk and uncontrolled hypertension [2][6] - There are over 7.7 million patients in the U.S. who meet the criteria for this therapy [2][6] - AVIM therapy is currently being evaluated in the BACKBEAT global pivotal study, which is a collaboration between Orchestra BioMed and Medtronic [2][3][7] Market Potential and Collaboration - The collaboration with Medtronic allows for the development and commercialization of AVIM therapy, particularly for patients indicated for pacemakers [7][8] - The Breakthrough Device Designation may facilitate favorable reimbursement pathways, including eligibility for NTAP and TPT under CMS programs [4][11] Clinical Efficacy - Pilot studies have shown that AVIM therapy can lead to significant reductions in blood pressure, with net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure and 12.3 mmHg in office systolic blood pressure at six months [10]

Company Performance - Orchestra BioMed Holdings, Inc. reported a quarterly loss of $0.43 per share, which aligns with the Zacks Consensus Estimate, compared to a loss of $0.37 per share a year ago [1] - The company posted revenues of $0.25 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 67.85%, and down from $0.26 million year-over-year [2] - Over the last four quarters, the company has surpassed consensus EPS estimates two times and topped consensus revenue estimates just once [2][1] Stock Movement and Outlook - Shares of Orchestra BioMed Holdings, Inc. have increased by approximately 10% since the beginning of the year, contrasting with a decline of -5.1% in the S&P 500 [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The current consensus EPS estimate for the coming quarter is -$0.46 on revenues of $0.74 million, and for the current fiscal year, it is -$1.95 on revenues of $3.84 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Orchestra BioMed belongs, is currently ranked in the top 27% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5]

Core Insights - Orchestra BioMed is focused on executing the BACKBEAT global pivotal study, which aims to establish AVIM therapy as a new standard of care for uncontrolled hypertension in pacemaker patients [2][5] - The company is also preparing to initiate a U.S. coronary pivotal study for the Virtue SAB program, with an updated trial design currently under FDA review [2][5] - The company is entering a formal mediation process with Terumo to resolve partnership negotiations, aiming for a resolution in the second quarter of 2025 [2][5] Financial Results for 2024 - Cash and cash equivalents and marketable securities totaled $66.8 million as of December 31, 2024 [10] - Revenue for 2024 was $2.6 million, a decrease from $2.8 million in 2023, primarily due to reduced partnership revenues from Terumo [10] - Research and development expenses increased to $42.8 million in 2024 from $33.8 million in 2023, driven by costs associated with the BACKBEAT study [10] - The net loss for 2024 was $61.0 million, or ($1.66) per share, compared to a net loss of $49.1 million, or ($1.48) per share, in 2023 [10][17] Product Development and Partnerships - AVIM therapy has shown promising results in pilot studies, with net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure and 12.3 mmHg in office systolic blood pressure at six months [8] - Virtue SAB is designed to deliver an extended-release formulation of sirolimus during balloon angioplasty without the need for a coating on the balloon surface [9] - The FDA has granted Breakthrough Device designation to Virtue SAB for specific indications, enhancing its development prospects [11] Leadership and Governance - The board of directors has been enhanced with the appointment of three experienced independent directors, including former executives from Medtronic and Siemens [5] - Mark Pomeranz has been appointed as Executive Vice President & General Manager, bringing over two decades of experience in medical devices [5]