Orchestra BioMed Reports Third Quarter 2024 Financial Results and Provides a Business Update
Orchestra BioMed (NASDAQ: OBIO) reported Q3 2024 financial results with revenue of $1.0 million, up from $0.4 million in Q3 2023. The company posted a net loss of $15.4 million ($0.41 per share). Cash position stood at $66.9 million as of September 30, 2024, with an additional $15 million drawn from Hercules Capital facility in November. R&D expenses increased to $11.6 million due to BACKBEAT study costs. The company continues to advance its BACKBEAT global pivotal study with Medtronic and is preparing for Virtue SAB coronary pivotal studies. Operating runway is expected into second half of 2026.
Orchestra BioMed (NASDAQ: OBIO) ha riportato i risultati finanziari del terzo trimestre 2024, con ricavi di 1,0 milioni di dollari, in aumento rispetto ai 0,4 milioni di dollari del terzo trimestre 2023. L'azienda ha registrato una perdita netta di 15,4 milioni di dollari (0,41 dollari per azione). La posizione di liquidità si attestava a 66,9 milioni di dollari al 30 settembre 2024, con ulteriori 15 milioni prelevati dalla struttura di Hercules Capital a novembre. Le spese per R&S sono aumentate a 11,6 milioni di dollari a causa dei costi dello studio BACKBEAT. L'azienda continua a portare avanti il suo studio globale cruciale BACKBEAT con Medtronic ed è in preparazione per gli studi pivotal coronarici Virtue SAB. Si prevede che il margine operativo si estenda fino alla seconda metà del 2026.
Orchestra BioMed (NASDAQ: OBIO) reportó los resultados financieros del tercer trimestre de 2024, con ingresos de 1,0 millones de dólares, un aumento desde 0,4 millones de dólares en el tercer trimestre de 2023. La compañía registró una pérdida neta de 15,4 millones de dólares (0,41 dólares por acción). La posición de efectivo se situaba en 66,9 millones de dólares al 30 de septiembre de 2024, con otros 15 millones retirados de la instalación de Hercules Capital en noviembre. Los gastos de I+D aumentaron a 11,6 millones de dólares debido a los costos del estudio BACKBEAT. La compañía sigue avanzando en su estudio pivotal global BACKBEAT con Medtronic y se está preparando para los estudios coronarios pivotal Virtue SAB. Se espera que la pista operativa se extienda hasta la segunda mitad de 2026.
Orchestra BioMed (NASDAQ: OBIO)는 2024년 3분기 재무 결과를 발표했으며, 수익은 100만 달러로 2023년 3분기의 40만 달러에서 증가했습니다. 회사는 1540만 달러의 순손실을 기록했습니다(주당 0.41달러). 현금 보유량은 2024년 9월 30일 기준으로 6690만 달러였으며, 11월에는 Hercules Capital 시설에서 추가로 1500만 달러를 인출했습니다. R&D 비용은 BACKBEAT 연구 비용 때문에 1160만 달러로 증가했습니다. 회사는 Medtronic과 함께 BACKBEAT 글로벌 주요 연구를 진행하고 있으며, Virtue SAB 관상동맥 주요 연구를 준비 중입니다. 운영 자금은 2026년 하반기까지 지속될 것으로 예상됩니다.
Orchestra BioMed (NASDAQ: OBIO) a publié ses résultats financiers du troisième trimestre 2024, avec des revenus de 1,0 million de dollars, en hausse par rapport à 0,4 million de dollars au troisième trimestre 2023. La société a enregistré une perte nette de 15,4 millions de dollars (0,41 dollar par action). La position de trésorerie était de 66,9 millions de dollars au 30 septembre 2024, avec 15 millions supplémentaires tirés de l'installation de Hercules Capital en novembre. Les dépenses en R&D ont augmenté à 11,6 millions de dollars en raison des coûts liés à l'étude BACKBEAT. L'entreprise continue d'avancer dans son étude pivotale mondiale BACKBEAT avec Medtronic et se prépare pour les études coronaires pivotales Virtue SAB. Les fonds d'exploitation devraient durer jusqu'à la seconde moitié de 2026.
Orchestra BioMed (NASDAQ: OBIO) veröffentlichte die Finanzergebnisse für das dritte Quartal 2024 mit Einnahmen von 1,0 Millionen Dollar, ein Anstieg von 0,4 Millionen Dollar im dritten Quartal 2023. Das Unternehmen verzeichnete einen Nettverlust von 15,4 Millionen Dollar (0,41 Dollar je Aktie). Die Liquiditätsposition betrug zum 30. September 2024 66,9 Millionen Dollar, mit weiteren 15 Millionen, die im November von der Finanzierungseinrichtung Hercules Capital abgerufen wurden. Die F&E-Ausgaben stiegen auf 11,6 Millionen Dollar aufgrund der Kosten der BACKBEAT-Studie. Das Unternehmen setzt seine globale Hauptstudie BACKBEAT mit Medtronic fort und bereitet sich auf die entscheidenden Studien zu den koronaren Virtue SAB vor. Der Betriebsspielraum wird bis in die zweite Hälfte des Jahres 2026 erwartet.
- Revenue increased 150% year-over-year to $1.0 million
- Secured additional $15 million from credit facility with Hercules Capital
- Extended cash runway into second half of 2026
- FDA approval received for BACKBEAT study protocol amendment
- Net loss increased to $15.4 million from $13.3 million year-over-year
- R&D expenses increased 34.9% to $11.6 million
- Operating cash burn increased to $13.8 million from $10.3 million year-over-year
Insights
Q3 2024 shows mixed financial signals.
Net loss widened to
The BACKBEAT study protocol amendment for improved patient engagement and expanded enrollment window is strategically important but suggests potential recruitment challenges. Partnership with Medtronic remains important for commercialization. The Virtue SAB program's positioning in the growing drug-coated balloon market shows promise, particularly given the TCT conference highlighting industry trends.
Vivasure's positive IDE PATCH study data for PerQseal with low complication rates strengthens potential for 2025 approval. Haemonetics'
NEW HOPE, Pa., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today reported its third quarter 2024 financial results and provided a business update.
"The Orchestra BioMed team is focused on execution of the BACKBEAT global pivotal study alongside our strategic partner, Medtronic. We are excited about the enthusiasm we have seen from the clinical community for the potential of AVIM therapy to provide these typically older, higher risk hypertension patients with a potent, programmable, always on treatment option for managing their blood pressure,” commented David Hochman, Chairman, Chief Executive Officer, and Founder of Orchestra BioMed. “We received FDA approval for and recently started to implement an important amendment to our study protocol that improves patient engagement processes and significantly expands our window for screening and enrollment. We believe this amendment will help us execute the ongoing study and deliver regulatory-submission-ready clinical results to our partners at Medtronic.”
Mr. Hochman continued, “In parallel with our work on AVIM therapy, we are continuing to advance our Virtue SAB program with active preparations to initiate coronary pivotal studies. The agenda at this year’s TCT conference highlighted the growing importance of drug-coated balloons in the future of coronary and peripheral interventions for artery disease. We view Virtue SAB as a revolutionary innovation that can elevate this rapidly accelerating therapeutic trend, offering superior drug delivery without the limitations of fragile balloon coatings. Overall, we expect 2025 to be a milestone year for Orchestra BioMed and remain steadfast in our commitment to employ our partnership-enabled business model to deliver innovative solutions that will make a meaningful impact on patient care."
Recent Business Highlights:
- Continued site activation and patient enrollment of the BACKBEAT global pivotal study, in collaboration with Medtronic (NYSE: MDT), evaluating the efficacy and safety of atrioventricular interval modulation (“AVIM”) therapy in hypertensive pacemaker patients.
- Received FDA approval for and are now implementing an amendment to the BACKBEAT study protocol intended to improve patient engagement processes and expand the window for screening and enrolling patients.
- Preparing to initiate coronary pivotal studies for Virtue® Sirolimus AngioInfusionTM Balloon (“SAB”).
- Actively engaged with Terumo in Virtue SAB partnership restructuring discussions.
- Vivasure Medical Ltd. (“Vivasure”), a strategic holding of Orchestra BioMed, reported positive data from its U.S. IDE PATCH pivotal study at the Transcatheter Cardiovascular Therapeutics (“TCT”) 2024 annual conference demonstrating that its PerQseal® Closure Device achieved closure with very low rates of major vascular complications and rapid times to hemostasis. This data positions PerQseal for potential regulatory approval and commercial launch in 2025.
- Haemonetics Corporation (NYSE: HAE) has invested over
$30 million in Vivasure and has an option to acquire the company.
- Haemonetics Corporation (NYSE: HAE) has invested over
Financial Results for the Third Quarter Ended September 30, 2024
- Cash and cash equivalents and Marketable securities totaled
$66.9 million as of September 30, 2024. Following the close of Q3 2024, cash and cash equivalents increased in November 2024 by approximately$15 million from the initial draw on our credit facility with Hercules Capital, Inc. Operating cash runway is expected into second half of 2026 based on internal forecast reflecting operating priorities and certain potential future proceeds. - Net cash used in operating activities and for the purchase of fixed assets was
$13.8 million during the third quarter of 2024, compared with$10.3 million for the third quarter of 2023, with the primary driver of this increase being increased cash outflows for research and development during the third quarter of 2024. - Revenue for the third quarter of 2024 was
$1.0 million , compared with$0.4 million for the third quarter in 2023. The increase was primarily due to increased recognition of partnership revenues earned under the agreement with Terumo. - Research and development expenses for the third quarter of 2024 were
$11.6 million , compared with$8.6 million for the same period in 2023. The increase was primarily due to additional costs associated with the ongoing BACKBEAT global pivotal study. - Selling, general and administrative expenses for the third quarter of 2024 were
$5.7 million , compared with$6.3 million for the third quarter of 2023. The decrease was primarily due to reduced expenses related to stock-based compensation. - Net loss for the third quarter of 2024 was
$15.4 million , or$0.41 per share, compared with a net loss of$13.3 million , or$0.38 per share, for 2023. Net loss for the third quarter of 2024 included non-cash stock-based compensation expense of$2.4 million as compared with$3.5 million for the same period in 2023.
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’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 as BackBeat Cardiac Neuromodulation Therapy (CNT™)) for the treatment of hypertension, a significant risk factor for death worldwide. Orchestra BioMed is also developing the Virtue® Sirolimus AngioInfusion™ Balloon (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. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn.
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, also known as BackBeat CNT™, 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. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will further evaluate the safety and efficacy of AVIM therapy in lowering blood pressure in a similar target population of patients who have been indicated for, and recently implanted with, a dual-chamber cardiac pacemaker.
About Virtue SAB
Virtue SAB is a patented drug/device combination product candidate in development for the treatment of certain forms of artery disease that is designed to deliver a proprietary, investigational, extended-release formulation of sirolimus, SirolimusEFR™, to the vessel wall during balloon angioplasty without any coating on the balloon surface or the need to leave a stent or other permanent implant in the artery. Virtue SAB demonstrated positive three-year clinical data in coronary ISR 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. Orchestra BioMed has a strategic partnership with Terumo (Terumo, TSE: 4543), a global leader in medical technology headquartered in Tokyo, Japan, as well as Terumo Medical Corporation, its U.S. subsidiary, to collaborate on the global development and commercialization of Virtue SAB in coronary and peripheral vascular indications.
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 “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” 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’s planned and ongoing pivotal trials and reporting of top-line results, realizing the clinical and commercial value of BackBeat CNT and Virtue SAB, the expected runway of the Company’s current cash, cash equivalents, marketable securities the Company’s ability to restructure its partnership agreement with Terumo, the potential safety and efficacy of the Company’s product candidates, regulatory approval Vivasure’s PerQseal® Closure Device and the timing of any acquisition of Vivasure, and the ability of the Company’s 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’s 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’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s annual report on Form 10-K for the year ended December 31, 2023, which was filed with the Securities and Exchange Commission (“SEC”) on March 27, 2024 , and under the heading “Item1A. Risk Factors” in Part II of the Company’s quarterly report on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC on November 12, 2024.
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.
| ORCHESTRA BIOMED HOLDINGS, INC. | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (in thousands, except share and per share data) | ||||||||
| (Unaudited) | ||||||||
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 25,605 | $ | 30,559 | ||||
| Marketable securities | 41,321 | 56,968 | ||||||
| Strategic investments, current portion | — | 68 | ||||||
| Accounts receivable, net | 115 | 99 | ||||||
| Inventory | 234 | 146 | ||||||
| Prepaid expenses and other current assets | 1,278 | 1,274 | ||||||
| Total current assets | 68,553 | 89,114 | ||||||
| Property and equipment, net | 1,254 | 1,279 | ||||||
| Right-of-use assets | 1,714 | 1,555 | ||||||
| Strategic investments, less current portion | 2,495 | 2,495 | ||||||
| Deposits and other assets | 1,303 | 769 | ||||||
| TOTAL ASSETS | $ | 75,319 | $ | 95,212 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable | $ | 4,723 | $ | 2,900 | ||||
| Accrued expenses and other liabilities | 7,034 | 5,149 | ||||||
| Operating lease liability, current portion | 395 | 649 | ||||||
| Deferred revenue, current portion | 4,066 | 2,510 | ||||||
| Total current liabilities | 16,218 | 11,208 | ||||||
| Deferred revenue, less current portion | 11,439 | 14,923 | ||||||
| Operating lease liability, less current portion | 1,443 | 1,038 | ||||||
| TOTAL LIABILITIES | 29,100 | 27,169 | ||||||
| STOCKHOLDERS’ EQUITY | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 4 | 4 | ||||||
| Additional paid-in capital | 339,840 | 316,903 | ||||||
| Accumulated other comprehensive income (loss) | 98 | (10 | ) | |||||
| Accumulated deficit | (293,723 | ) | (248,854 | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY | 46,219 | 68,043 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 75,319 | $ | 95,212 | ||||
| ORCHESTRA BIOMED HOLDINGS, INC. | |||||||||
| Condensed Consolidated Statements of Operations and Comprehensive Loss | |||||||||
| (in thousands, except share and per share data) | |||||||||
| (Unaudited) | |||||||||
| Three Months Ended September 30, | |||||||||
| 2024 | 2023 | ||||||||
| Revenue: | |||||||||
| Partnership revenue | $ | 803 | $ | 271 | |||||
| Product revenue | 184 | 148 | |||||||
| Total revenue | 987 | 419 | |||||||
| Expenses: | |||||||||
| Cost of product revenues | 68 | 41 | |||||||
| Research and development | 11,595 | 8,558 | |||||||
| Selling, general and administrative | 5,666 | 6,344 | |||||||
| Total expenses | 17,329 | 14,943 | |||||||
| Loss from operations | (16,342 | ) | (14,524 | ) | |||||
| Other income (expense): | |||||||||
| Interest income, net | 916 | 915 | |||||||
| Gain (loss) on fair value of strategic investments | — | 293 | |||||||
| Total other income | 916 | 1,208 | |||||||
| Net loss | $ | (15,426 | ) | $ | (13,316 | ) | |||
| Net loss per share | |||||||||
| Basic and diluted | $ | (0.41 | ) | $ | (0.38 | ) | |||
| Weighted-average shares used in computing net loss per share, basic and diluted | 37,621,495 | 35,243,598 | |||||||
| Comprehensive loss | |||||||||
| Net loss | $ | (15,426 | ) | $ | (13,316 | ) | |||
| Unrealized gain (loss) on marketable securities | 121 | 19 | |||||||
| Comprehensive loss | $ | (15,305 | ) | $ | (13,297 | ) | |||
FAQ
What was Orchestra BioMed's (OBIO) revenue in Q3 2024?
How much cash does Orchestra BioMed (OBIO) have as of Q3 2024?
What was Orchestra BioMed's (OBIO) net loss in Q3 2024?
How long is Orchestra BioMed's (OBIO) cash runway expected to last?
