Orchestra BioMed Reports Second Quarter 2025 Financial Results and Highlights Recent Business Updates
Orchestra BioMed (NASDAQ:OBIO) reported Q2 2025 financial results and significant business developments. The company secured $111.2 million in total proceeds through strategic transactions and equity offerings, including $71 million from Medtronic and Ligand. This funding is expected to extend their cash runway into H2 2027.
Key regulatory achievements include FDA Breakthrough Device Designation for AVIM therapy, expanded enrollment criteria approval for the BACKBEAT study, and IDE approval for the Virtue SAB U.S. pivotal trial. Q2 2025 financial results showed revenue of $0.8 million, with a net loss of $19.4 million ($0.50 per share). Cash position as of August 12, 2025, stood at $101 million.
Orchestra BioMed (NASDAQ:OBIO) ha comunicato i risultati finanziari del secondo trimestre 2025 e importanti sviluppi aziendali. La societ脿 ha ottenuto $111,2 milioni di proventi complessivi tramite operazioni strategiche e aumenti di capitale, inclusi $71 milioni da Medtronic e Ligand. Tale finanziamento dovrebbe estendere la liquidit脿 fino al secondo semestre 2027.
I principali traguardi regolatori comprendono la designazione Breakthrough Device della FDA per la terapia AVIM, l'approvazione dell'ampliamento dei criteri di arruolamento per lo studio BACKBEAT e l'approvazione dell'IDE per lo studio pivotale statunitense Virtue SAB. Nel Q2 2025 i ricavi sono stati di $0,8 milioni, con una perdita netta di $19,4 milioni (pari a $0,50 per azione). La posizione di cassa al 12 agosto 2025 era di $101 milioni.
Orchestra BioMed (NASDAQ:OBIO) anunci贸 los resultados financieros del segundo trimestre de 2025 y avances empresariales relevantes. La compa帽铆a obtuvo $111,2 millones en ingresos totales mediante transacciones estrat茅gicas y emisiones de acciones, incluyendo $71 millones de Medtronic y Ligand. Este financiamiento deber铆a ampliar su liquidez hasta la segunda mitad de 2027.
Los logros regulatorios clave incluyen la designaci贸n Breakthrough Device de la FDA para la terapia AVIM, la aprobaci贸n de criterios ampliados de inclusi贸n para el estudio BACKBEAT y la aprobaci贸n del IDE para el ensayo pivotal estadounidense Virtue SAB. En el Q2 2025 los ingresos fueron de $0,8 millones, con una p茅rdida neta de $19,4 millones ($0,50 por acci贸n). La posici贸n de efectivo al 12 de agosto de 2025 era de $101 millones.
Orchestra BioMed (NASDAQ:OBIO)鞚�(臧�) 2025雲� 2攵勱赴 鞁れ爜瓿� 欤检殧 靷梾 歆勳爠鞚� 氚滍憸頄堨姷雼堧嫟. 須岇偓電� 鞝勲灥鞝� 瓯半灅鞕� 鞙犾儊歃濎瀽毳� 韱淀暣 齑� $111.2 million鞚� 鞛愱笀鞚� 頇曤炒頄堨溂氅�, 攴胳 $71 million鞚� Medtronic瓿� Ligand搿滊秬韯� 臁半嫭頄堨姷雼堧嫟. 鞚� 鞛愱笀鞚� 順勱笀 靻岇 鞁滌爯鞚� 2027雲� 頃橂皹旮瓣箤歆� 鞐办灔頃� 瓴冹溂搿� 鞓堨儊霅╇媹雼�.
欤检殧 攴滌牅 靹标臣搿滊姅 AVIM 旃橂氩曥棎 雽�頃� FDA Breakthrough Device 歆�鞝�, BACKBEAT 鞐瓣惮鞚� 霌彪 旮办 頇曤寑 鞀轨澑, 攴鸽Μ瓿� Virtue SAB 氙戈淡 頂茧矖霟� 鞁滍棙鞐� 雽�頃� IDE 鞀轨澑 霌膘澊 鞛堨姷雼堧嫟. 2025雲� 2攵勱赴 鞁れ爜鞚� 毵れ稖 $0.8 million, 靾滌啇鞁� $19.4 million(欤茧嫻 $0.50)鞚� 旮半頄堨姷雼堧嫟. 2025雲� 8鞗� 12鞚� 旮办 順勱笀 氤挫湢鞎§潃 $101 million鞛呺媹雼�.
Orchestra BioMed (NASDAQ:OBIO) a publi茅 ses r茅sultats financiers du 2e trimestre 2025 et des d茅veloppements commerciaux majeurs. La soci茅t茅 a obtenu 111,2 M$ de produits au total via des op茅rations strat茅giques et des 茅missions d'actions, dont 71 M$ de Medtronic et Ligand. Ce financement devrait prolonger sa tr茅sorerie jusqu'au second semestre 2027.
Parmi les avanc茅es r茅glementaires cl茅s figurent la d茅signation Breakthrough Device de la FDA pour la th茅rapie AVIM, l'approbation de l'茅largissement des crit猫res d'inclusion pour l'茅tude BACKBEAT et l'autorisation IDE pour l'essai pivot am茅ricain Virtue SAB. Les r茅sultats du T2 2025 font 茅tat d'un chiffre d'affaires de 0,8 M$, d'une perte nette de 19,4 M$ (soit 0,50 $ par action). La tr茅sorerie au 12 ao没t 2025 s'茅levait 脿 101 M$.
Orchestra BioMed (NASDAQ:OBIO) gab die Finanzergebnisse f眉r Q2 2025 und wichtige gesch盲ftliche Entwicklungen bekannt. Das Unternehmen sicherte sich insgesamt $111,2 Millionen an Erl枚sen durch strategische Transaktionen und Kapitalma脽nahmen, darunter $71 Millionen von Medtronic und Ligand. Diese Finanzierung soll den Cash-Runway bis in die zweite H盲lfte 2027 verl盲ngern.
Zentrale regulatorische Erfolge umfassen die FDA Breakthrough Device Designation f眉r die AVIM-Therapie, die Genehmigung erweiterter Einschlusskriterien f眉r die BACKBEAT-Studie und die IDE-Zulassung f眉r die Virtue SAB US-pivotal-Studie. F眉r Q2 2025 wurden Umsatzerl枚se von $0,8 Millionen und ein Nettoverlust von $19,4 Millionen (entsprechend $0,50 pro Aktie) ausgewiesen. Die Liquidit盲tsposition zum 12. August 2025 belief sich auf $101 Millionen.
- None.
- Net loss increased to $19.4 million in Q2 2025 from $16.0 million in Q2 2024
- R&D expenses increased to $13.9 million from $11.1 million year-over-year
- Net cash burn increased to $15.6 million from $10.3 million year-over-year
- Flat revenue at $0.8 million compared to previous year
Insights
Orchestra BioMed secures $111M funding and achieves key FDA milestones, extending cash runway while advancing late-stage cardiovascular device programs.
Orchestra BioMed has executed a strategic financial restructuring that significantly strengthens its position to advance its cardiovascular device portfolio. The company has secured
The regulatory achievements are particularly noteworthy. The FDA Breakthrough Device Designation for AVIM therapy in patients with uncontrolled hypertension validates the technology's potential and could accelerate its path to market with enhanced reimbursement opportunities. The approval of expanded enrollment criteria for the BACKBEAT study is a strategic win, increasing the eligible patient pool by 24-fold, which should accelerate enrollment completion targeted for mid-2026. Additionally, the IDE approval for Virtue SAB's pivotal trial positions it for direct comparison against an established paclitaxel-coated balloon.
From a financial perspective, while quarterly revenue remained flat at
The FDA regulatory milestones achieved by Orchestra BioMed represent significant advancements for both of their lead device programs. The Breakthrough Device Designation (BDD) for their AVIM therapy is particularly meaningful as it indicates the FDA recognizes this technology addresses an unmet need in patients with uncontrolled hypertension and increased cardiovascular risk. This designation provides Orchestra with prioritized review processes, more interactive communication with the FDA, and potentially accelerated approval pathways. Importantly, BDD status also opens the door for enhanced Medicare reimbursement opportunities through programs designed to promote adoption of breakthrough technologies.
The protocol amendment approval for the BACKBEAT study represents a critical operational enhancement. By expanding patient eligibility criteria to increase the potential patient pool by 24-fold, Orchestra has dramatically improved their ability to complete enrollment by their mid-2026 target. This type of protocol amendment requires substantial supporting data and FDA concurrence that the expanded criteria won't compromise study integrity or patient safety.
The IDE approval for the Virtue SAB pivotal trial is equally significant, particularly because it's structured as a head-to-head comparison against an established paclitaxel-coated balloon (AGENT DCB). This comparative trial design, which the FDA has endorsed through the IDE approval, suggests confidence in Virtue SAB's potential performance. Head-to-head trials against approved devices generally provide stronger evidence for regulatory approval and subsequent market adoption than trials against placebo or standard care. The planned initiation in H2 2025 aligns with the company's strengthened financial position.
The expansion of Orchestra's intellectual property portfolio to 137 issued patents worldwide further strengthens their market position and potential partnership opportunities in both hypertension and heart failure therapeutic areas.
- Secured over
$111 million in proceeds and committed capital following completion of strategic transactions and concurrent public and private equity offerings, led by over$71 million in committed capital from Medtronic and Ligand - Achieved multiple FDA regulatory milestones: Breakthrough Device Designation for AVIM therapy; approval for expanded BACKBEAT study enrollment criteria, and IDE approval for a U.S. pivotal Virtue SAB trial versus commercially available paclitaxel-coated balloon
NEW HOPE, Pa., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, 鈥淥rchestra BioMed鈥� or the 鈥淐ompany鈥�), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced financial results for the second quarter ended June 30, 2025, and provided a business update highlighting recent financial and regulatory milestones.
Q2 2025 and Recent Business Highlights:
- Completed multiple strategic transactions and concurrent public and private equity offerings totaling an expected
$111.2 million in gross proceeds to support continued advancement of the Company鈥檚 late-stage atrioventricular interval modulation (鈥淎VIM鈥�) therapy and Virtue Sirolimus AngioInfusion Balloon (鈥淪AB鈥�) clinical programs. Gross proceeds are comprised of:$55 million received or to be received by May 1, 2026, subject to certain conditions, from royalty-based, non-dilutive investments from Ligand Pharmaceuticals Incorporated (Nasdaq: LGND, 鈥淟igand鈥�) and Medtronic, plc (NYSE: MDT, 鈥淢edtronic鈥�)- Ligand committed
$35 million in exchange for a tiered revenue interest in Orchestra BioMed鈥檚 future royalties from AVIM therapy and Virtue SAB - Medtronic committed
$20 million in exchange for a secured subordinated promissory note convertible to capped prepaid revenue share
- Ligand committed
$56.2 million received from a$40 million underwritten public offering of common stock and prefunded warrants and$11.2 million and$5 million received from private placements of common stock to Medtronic and Ligand, respectively- Proceeds expected to extend cash runway into the second half of 2027, supporting potentially significant value-creating catalysts, including:
- BACKBEAT study enrollment completion in mid-2026
- BACKBEAT study primary endpoint data
- Substantial enrollment of the Virtue Trial
- Medtronic and Orchestra BioMed expanded strategic collaboration to provide pathway for future development of AVIM therapy-enabled leadless pacemakers.
- U.S. Food and Drug Administration (鈥淔DA鈥�) Breakthrough Device Designation (鈥淏DD鈥�)听granted for atrioventricular interval modulation (鈥淎VIM鈥�) therapy in patients with uncontrolled hypertension and increased cardiovascular risk, marking a major regulatory validation of the therapy's potential to improve hypertensive heart disease outcomes.
- FDA-approved updated BACKBEAT study protocol now being implemented, broadening patient enrollment criteria for a more than 24-fold increase in the potentially eligible patient pool; full implementation to be completed in Q4 2025.
- FDA Investigational Device Exemption (鈥淚DE鈥�)听Approval received for the Virtue SAB U.S. pivotal trial, a randomized head-to-head study comparing Virtue SAB with the commercially available AGENT鈩⑻鼶CB paclitaxel-coated balloon (the 鈥淰irtue Trial鈥�). Trial initiation is currently targeted for the second half of 2025.
- Orchestra BioMed is sponsoring and in full operational control of the Virtue Trial; mediation with Terumo of certain other contractual terms is progressing, with conclusion of formal mediation process expected in Q3 2025.
- Intellectual Property Expansion continued with AVIM therapy patent estate reaching 137 issued patents worldwide, with recent additions bolstering coverage for both hypertension and heart failure indications.
Chairman and Chief Executive Officer (鈥淐EO鈥�) Commentary from David Hochman:
Mr. Hochman stated: 鈥淭he successful completion of strategic financing transactions with Medtronic and Ligand, along with closing our first underwritten public offering are expected to give us up to
Mr. Hochman continued: 鈥淲e were also proud to have achieved multiple key regulatory milestones for both AVIM therapy and Virtue SAB in the second quarter. The FDA Breakthrough Device Designation awarded to AVIM therapy for the treatment of uncontrolled hypertension in patients with increased cardiovascular risk has potentially significant implications to future regulatory submissions and opens up potential pathways for enhanced reimbursement for AVIM therapy-enabled devices. The FDA also approved an important update to the BACKBEAT study protocol that we are now rolling out to study centers that significantly expands eligibility criteria for enrollment and supports our enrollment completion objectives for next year. Finally, FDA approval of the updated IDE for our head-to-head pivotal trial comparing Virtue SAB to commercially available AGENT paclitaxel-coated balloon marks another significant regulatory milestone. These achievements will help us in our continued efforts to reshape clinical standards of care in both hypertensive heart disease and atherosclerotic artery disease.鈥�
Financial Results for the Second Quarter Ended June 30, 2025
- Cash and cash equivalents and Marketable securities totaled
$33.9 million as of June 30, 2025. Combined with net proceeds received from recent financing transactions, estimated Cash and cash equivalents and Marketable securities position was$101 million as of August 12, 2025. The Company has commitments from Ligand and Medtronic to receive a combined$35 million in additional proceeds on or before May 1, 2026, based on the terms of agreements with those parties. - Net cash used in operating activities and for the purchase of fixed assets was
$15.6 million during the second quarter of 2025, compared with$10.3 million for the second quarter in 2024, with the primary driver being increased research and development costs during the second quarter of 2025. - Revenue for the second quarter of 2025 was
$0.8 million , compared with$0.8 million for the second quarter in 2024. - Research and development expenses for the second quarter of 2025 were
$13.9 million , compared with$11.1 million for the second quarter in 2024. The increase was primarily due to additional costs associated with the ongoing BACKBEAT global pivotal study. - Selling, general and administrative expenses for the second quarter of 2025 were
$6.3 million , compared with$6.5 million for the second quarter of 2024. The decrease was primarily due to a decrease in professional fees. - Net loss for the second quarter of 2025 was
$19.4 million , or$0.50 per share, compared with a net loss of$16.0 million , or$0.45 per share, for the second quarter of 2024. Net loss for the second quarter of 2025 included$3.2 million in non-cash stock-based compensation expense as compared to$2.8 million for the same period in 2024.
About Orchestra BioMed
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鈥檚 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鈥檚 lead product candidate is AVIM therapy for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed is also developing Virtue SAB for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. The Company has received four Breakthrough Device Designations from the U.S. FDA across these two core programs, reflecting the significant potential of its technologies to address high unmet needs in cardiovascular care. For further information about Orchestra BioMed, please visit听, and follow us on听.
References to Websites and Social Media Platforms
References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release.
About AVIM Therapy
AVIM therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will evaluate the safety and efficacy of AVIM therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM therapy has been granted Breakthrough Device Designation by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk.
About Virtue SAB
Virtue SAB is an investigational therapeutic combination drug-device designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR鈩� through a non-coated microporous AngioInfusion鈩� Balloon, protecting the drug in transit through the arteries and consistently delivering a large liquid dose, overcoming certain limitations of drug-coated balloons. SirolimusEFR delivered by Virtue SAB has been shown in published preclinical series involving hundreds of arterial deliveries to achieve sustained tissue levels well above the known required therapeutic tissue concentration for inhibiting restenosis (1 ng/mg tissue) for the entire critical healing period of approximately 30 days. Virtue SAB demonstrated positive three-year clinical data in coronary in-stent restenosis (鈥淚SR鈥�) in the SABRE study, a multi-center prospective, independent core lab-adjudicated clinical study conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for specific indications relating to coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee. The FDA granted IDE approval for Orchestra BioMed to evaluate the efficacy and safety of Virtue SAB in the Virtue Trial, a pivotal trial that will randomize Virtue SAB against commercially available AGENT鈩⑻鼶CB, a paclitaxel-coated balloon.
Forward-Looking Statements
Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as 鈥渂elieve,鈥� 鈥渕ay,鈥� 鈥渨ill,鈥� 鈥渆stimate,鈥� 鈥渃ontinue,鈥� 鈥渁nticipate,鈥� 鈥渋ntend,鈥� 鈥渆xpect,鈥� 鈥渟hould,鈥� 鈥渨ould,鈥� 鈥減lan,鈥� 鈥減redict,鈥� 鈥減otential,鈥� 鈥渟eem,鈥� 鈥渟eek,鈥� 鈥渇uture,鈥� 鈥渙utlook鈥� and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the initiation, enrollment, timing, implementation and design of the Company鈥檚 planned and ongoing pivotal trials, including the timing of completion of enrollment in the BACKBEAT study and the timing of initiation of the Virtue Trial, the receipt of committed capital, the Company鈥檚 expected cash runway, the date of completion of the formal mediation with Terumo, the potential benefits of BDD, realizing the clinical and commercial value of AVIM therapy and Virtue SAB, the potential safety and efficacy of the Company鈥檚 product candidates, and the ability of the Company鈥檚 partnerships to accelerate clinical development. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company鈥檚 management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company鈥檚 commercial product candidates and ongoing regulation of the Company鈥檚 product candidates, if approved; the timing of, and the Company鈥檚 ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading 鈥淚tem 1A. Risk Factors鈥� in the Company鈥檚 Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 31, 2025 and the risk factor discussed under the heading 鈥淚tem 1A. Risk Factors鈥� in the Company鈥檚 Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, which was filed with the SEC on May 12, 2025.
The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law.
Investor Contact
Silas Newcomb
Orchestra BioMed
Media Contact
Kelsey Kirk-Ellis
Orchestra BioMed
| ORCHESTRA BIOMED HOLDINGS,听INC. Condensed Consolidated Balance Sheets (in thousands, except share and per share data) (Unaudited) | |||||||||||||||
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| 听 | 听 | 2025 | 听 | 2024 | |||||||||||
| ASSETS | 听 | 听 | 听 | 听 | 听 | 听 | |||||||||
| CURRENT ASSETS: | 听 | 听 | 听 | 听 | 听 | 听 | |||||||||
| Cash and cash equivalents | 听 | $ | 18,749 | 听 | 听 | $ | 22,261 | 听 | |||||||
| Marketable securities | 听 | 听 | 15,175 | 听 | 听 | 听 | 44,551 | 听 | |||||||
| Accounts receivable, net | 听 | 听 | 83 | 听 | 听 | 听 | 92 | 听 | |||||||
| Inventory | 听 | 听 | 185 | 听 | 听 | 听 | 173 | 听 | |||||||
| Prepaid expenses and other current assets | 听 | 听 | 1,690 | 听 | 听 | 听 | 2,094 | 听 | |||||||
| Total current assets | 听 | 听 | 35,882 | 听 | 听 | 听 | 69,171 | 听 | |||||||
| Property and equipment, net | 听 | 听 | 1,366 | 听 | 听 | 听 | 1,384 | 听 | |||||||
| Right-of-use assets | 听 | 听 | 1,806 | 听 | 听 | 听 | 2,103 | 听 | |||||||
| Strategic investments | 听 | 听 | 2,495 | 听 | 听 | 听 | 2,495 | 听 | |||||||
| Deposits and other assets | 听 | 听 | 1,276 | 听 | 听 | 听 | 1,020 | 听 | |||||||
| TOTAL ASSETS | 听 | $ | 42,825 | 听 | 听 | $ | 76,173 | 听 | |||||||
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| LIABILITIES AND STOCKHOLDERS鈥� EQUITY | 听 | 听 | 听 | 听 | 听 | 听 | |||||||||
| CURRENT LIABILITIES: | 听 | 听 | 听 | 听 | 听 | 听 | |||||||||
| Accounts payable | 听 | $ | 5,308 | 听 | 听 | $ | 5,134 | 听 | |||||||
| Accrued expenses and other liabilities | 听 | 听 | 6,650 | 听 | 听 | 听 | 6,084 | 听 | |||||||
| Operating lease liability, current portion | 听 | 听 | 642 | 听 | 听 | 听 | 550 | 听 | |||||||
| Deferred revenue, current portion | 听 | 听 | 4,461 | 听 | 听 | 听 | 4,439 | 听 | |||||||
| Total current liabilities | 听 | 听 | 17,061 | 听 | 听 | 听 | 16,207 | 听 | |||||||
| Deferred revenue, less current portion | 听 | 听 | 9,568 | 听 | 听 | 听 | 10,989 | 听 | |||||||
| Loan payable | 听 | 听 | 14,384 | 听 | 听 | 听 | 14,292 | 听 | |||||||
| Operating lease liability, less current portion | 听 | 听 | 1,328 | 听 | 听 | 听 | 1,687 | 听 | |||||||
| Other long-term liabilities | 听 | 听 | 189 | 听 | 听 | 听 | 40 | 听 | |||||||
| TOTAL LIABILITIES | 听 | 听 | 42,530 | 听 | 听 | 听 | 43,215 | 听 | |||||||
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| STOCKHOLDERS鈥� EQUITY | 听 | 听 | 听 | 听 | 听 | 听 | |||||||||
| Preferred stock, issued or outstanding at June听30,听2025 and December听31,听2024. | 听 | 听 | 鈥� | 听 | 听 | 听 | 鈥� | 听 | |||||||
| Common stock, 38,643,553 and 38,194,442 shares issued and outstanding as of June听30,听2025 and December听31,听2024, respectively. | 听 | 听 | 4 | 听 | 听 | 听 | 4 | 听 | |||||||
| Additional paid-in capital | 听 | 听 | 348,271 | 听 | 听 | 听 | 342,780 | 听 | |||||||
| Accumulated other comprehensive income | 听 | 听 | 16 | 听 | 听 | 听 | 52 | 听 | |||||||
| Accumulated deficit | 听 | 听 | (347,996 | ) | 听 | 听 | (309,878 | ) | |||||||
| TOTAL STOCKHOLDERS鈥� EQUITY | 听 | 听 | 295 | 听 | 听 | 听 | 32,958 | 听 | |||||||
| TOTAL LIABILITIES AND STOCKHOLDERS鈥� EQUITY | 听 | $ | 42,825 | 听 | 听 | $ | 76,173 | 听 | |||||||
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| ORCHESTRA BIOMED HOLDINGS,听INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) (Unaudited) | ||||||||
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| 听 | 听 | Three Months Ended June听30, | ||||||
| 听 | 听 | 2025 | 听 | 2024 | ||||
| Revenue: | 听 | 听 | 听 | 听 | 听 | 听 | ||
| Partnership revenue | 听 | $ | 667 | 听 | 听 | $ | 628 | 听 |
| Product revenue | 听 | 听 | 169 | 听 | 听 | 听 | 150 | 听 |
| Total revenue | 听 | 听 | 836 | 听 | 听 | 听 | 778 | 听 |
| Expenses: | 听 | 听 | 听 | 听 | 听 | 听 | ||
| Cost of product revenues | 听 | 听 | 46 | 听 | 听 | 听 | 44 | 听 |
| Research and development | 听 | 听 | 13,853 | 听 | 听 | 听 | 11,126 | 听 |
| Selling, general and administrative | 听 | 听 | 6,264 | 听 | 听 | 听 | 6,467 | 听 |
| Total expenses | 听 | 听 | 20,163 | 听 | 听 | 听 | 17,637 | 听 |
| Loss from operations | 听 | 听 | (19,327 | ) | 听 | 听 | (16,859 | ) |
| Other (expense) income: | 听 | 听 | 听 | 听 | 听 | 听 | ||
| Interest (expense) income, net | 听 | 听 | (36 | ) | 听 | 听 | 902 | 听 |
| Loss on fair value of strategic investments | 听 | 听 | - | 听 | 听 | 听 | (23 | ) |
| Total other (expense) income | 听 | 听 | (36 | ) | 听 | 听 | 879 | 听 |
| Net loss | 听 | $ | (19,363 | ) | 听 | $ | (15,980 | ) |
| Net loss per share | 听 | 听 | 听 | 听 | 听 | 听 | ||
| Basic and diluted | 听 | $ | (0.50 | ) | 听 | $ | (0.45 | ) |
| Weighted-average shares used in computing net loss per share, basic and diluted | 听 | 听 | 38,392,716 | 听 | 听 | 听 | 35,800,273 | 听 |
| Comprehensive loss | 听 | 听 | 听 | 听 | 听 | 听 | ||
| Net loss | 听 | $ | (19,363 | ) | 听 | $ | (15,980 | ) |
| Unrealized loss on marketable securities | 听 | 听 | (21 | ) | 听 | 听 | (15 | ) |
| Comprehensive loss | 听 | $ | (19,384 | ) | 听 | $ | (15,995 | ) |
FAQ
What were Orchestra BioMed's (OBIO) key financial results for Q2 2025?
How much funding did Orchestra BioMed secure in their recent transactions?
What major FDA designations did Orchestra BioMed receive in Q2 2025?
How long will Orchestra BioMed's current cash runway last?
What is the status of Orchestra BioMed's BACKBEAT study enrollment?
