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Orchestra BioMed Reports Second Quarter 2024 Financial Results and Provides a Business Update

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Orchestra BioMed (Nasdaq: OBIO) reported Q2 2024 financial results and provided a business update. Key highlights include:

- Cash and cash equivalents: $65.2 million as of June 30, 2024

- Revenue: $0.8 million, down from $0.9 million in Q2 2023

- Net loss: $16.0 million ($0.45 per share), compared to $12.0 million ($0.35 per share) in Q2 2023

- R&D expenses: $11.1 million, up from $8.5 million in Q2 2023

The company remains focused on its AVIM therapy for hypertension and Virtue SAB program. The BACKBEAT global pivotal study is ongoing, with updates on the Virtue SAB program expected in H2 2024. Orchestra BioMed anticipates its cash runway to extend into H2 2026.

Orchestra BioMed (Nasdaq: OBIO) ha riportato i risultati finanziari del secondo trimestre del 2024 e fornito un aggiornamento aziendale. I punti salienti includono:

- Liquidità e mezzi equivalenti: $65.2 milioni al 30 giugno 2024

- Ricavi: $0.8 milioni, in calo rispetto a $0.9 milioni nel secondo trimestre del 2023

- Perdita netta: $16.0 milioni ($0.45 per azione), rispetto a $12.0 milioni ($0.35 per azione) nel secondo trimestre del 2023

- Spese per R&S: $11.1 milioni, in aumento rispetto a $8.5 milioni nel secondo trimestre del 2023

La società rimane focalizzata sulla sua terapia AVIM per l'ipertensione e sul programma Virtue SAB. Lo studio pivotale globale BACKBEAT è in corso, con aggiornamenti sul programma Virtue SAB attesi per la seconda metà del 2024. Orchestra BioMed prevede che la propria cassa si estenderà fino alla seconda metà del 2026.

Orchestra BioMed (Nasdaq: OBIO) reportó los resultados financieros del segundo trimestre de 2024 y proporcionó una actualización empresarial. Los puntos clave incluyen:

- Efectivo y equivalentes: $65.2 millones a 30 de junio de 2024

- Ingresos: $0.8 millones, una disminución desde $0.9 millones en el segundo trimestre de 2023

- Pérdida neta: $16.0 millones ($0.45 por acción), en comparación con $12.0 millones ($0.35 por acción) en el segundo trimestre de 2023

- Gastos de I+D: $11.1 millones, en aumento desde $8.5 millones en el segundo trimestre de 2023

La empresa sigue centrada en su terapia AVIM para la hipertensión y el programa Virtue SAB. El estudio pivotal global BACKBEAT está en curso, con actualizaciones sobre el programa Virtue SAB esperadas para la segunda mitad de 2024. Orchestra BioMed anticipa que su liquidez se extenderá hasta la segunda mitad de 2026.

Orchestra BioMed (Nasdaq: OBIO)는 2024년 2분기 재무 결과를 보고하고 비즈니스 업데이트를 제공했습니다. 주요 요점은 다음과 같습니다:

- 현금 및 현금성 자산: $65.2 백만 (2024년 6월 30일 기준)

- 수익: $0.8 백만, 2023년 2분기 $0.9 백만에서 감소

- 순손실: $16.0 백만 ($0.45 주당), 2023년 2분기 $12.0 백만 ($0.35 주당)과 비교

- 연구개발비: $11.1 백만, 2023년 2분기 $8.5 백만에서 증가

회사는 고혈압 치료를 위한 AVIM 치료제와 Virtue SAB 프로그램에 집중하고 있습니다. BACKBEAT 글로벌 피벗 연구는 진행 중이며, Virtue SAB 프로그램에 대한 업데이트는 2024년 하반기에 예상됩니다. Orchestra BioMed는 현금 여유가 2026년 하반기까지 이어질 것으로 예상하고 있습니다.

Orchestra BioMed (Nasdaq: OBIO) a annoncé ses résultats financiers pour le deuxième trimestre 2024 et a fourni une mise à jour de l'entreprise. Les points clés incluent :

- Trésorerie et équivalents : $65.2 millions au 30 juin 2024

- Chiffre d'affaires : $0.8 millions, en baisse par rapport à $0.9 millions au deuxième trimestre 2023

- Perte nette : $16.0 millions ($0.45 par action), par rapport à $12.0 millions ($0.35 par action) au deuxième trimestre 2023

- Dépenses R&D : $11.1 millions, en hausse par rapport à $8.5 millions au deuxième trimestre 2023

L'entreprise reste concentrée sur sa thérapie AVIM pour l'hypertension et le programme Virtue SAB. L'étude pivotale mondiale BACKBEAT est en cours, avec des mises à jour sur le programme Virtue SAB attendues pour la deuxième moitié de 2024. Orchestra BioMed s'attend à ce que sa trésorerie s'étende jusqu'à la deuxième moitié de 2026.

Orchestra BioMed (Nasdaq: OBIO) berichtete über die finanziellen Ergebnisse des zweiten Quartals 2024 und gab ein Unternehmensupdate. Zu den wichtigsten Punkten gehören:

- Kassenbestand und liquide Mittel: $65,2 Millionen zum 30. Juni 2024

- Umsatz: $0,8 Millionen, rückläufig von $0,9 Millionen im zweiten Quartal 2023

- Nettoverlust: $16,0 Millionen ($0,45 pro Aktie), im Vergleich zu $12,0 Millionen ($0,35 pro Aktie) im zweiten Quartal 2023

- F&E-Ausgaben: $11,1 Millionen, gestiegen von $8,5 Millionen im zweiten Quartal 2023

Das Unternehmen konzentriert sich weiterhin auf seine AVIM-Therapie zur Behandlung von Bluthochdruck und das Virtue SAB-Programm. Die globale BACKBEAT-Studie läuft, und Updates zum Virtue SAB-Programm werden für die zweite Hälfte des Jahres 2024 erwartet. Orchestra BioMed erwartet, dass der Cash-Bestand bis in die zweite Hälfte des Jahres 2026 reicht.

Positive
  • Strategic collaboration with Medtronic for AVIM therapy development
  • Successful R&D Day highlighting potential of AVIM therapy
  • Appointment of John Mack, former Medtronic executive, to Board of Directors
  • $15 million cash increase in July 2024 from stock sale to institutional investor
  • Expected cash runway into second half of 2026
Negative
  • Revenue decreased to $0.8 million from $0.9 million in Q2 2023
  • Net loss increased to $16.0 million from $12.0 million in Q2 2023
  • R&D expenses increased to $11.1 million from $8.5 million in Q2 2023
  • Selling, general and administrative expenses increased to $6.5 million from $5.3 million in Q2 2023

Insights

Orchestra BioMed's Q2 2024 results reveal a mixed financial picture. The company's cash position remains strong at $65.2 million, bolstered by an additional $15 million from a stock sale in July. This extends their runway into H2 2026, providing ample time for R&D progression. However, the widening net loss of $16.0 million (33% increase YoY) is concerning.

Revenue declined slightly to $0.8 million, while R&D expenses surged by 30.6% to $11.1 million, primarily due to the BACKBEAT study. This increased burn rate could pressure finances if not offset by future partnership revenues or capital raises. The 22.6% rise in SG&A expenses also warrants monitoring for cost control.

Orchestra BioMed's focus on AVIM therapy for hypertension in pacemaker patients shows promise. The BACKBEAT study's progress and positive KOL feedback at the R&D Day suggest potential for addressing a significant unmet need. With 75% of hypertensive patients not meeting treatment goals, this market opportunity is substantial.

The company's collaboration with Medtronic, a leader in cardiac devices, lends credibility and potential for rapid market penetration if approved. The Virtue SAB program for coronary artery disease adds diversification. However, investors should note that both programs are still in development stages, with pivotal data pending. The emphasis on "renaissance" in cardiac pacing and balloon angioplasty indicates a strategic positioning in evolving cardiovascular care paradigms.

NEW HOPE, Pa., Aug. 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 second quarter 2024 financial results and provided a business update.

"Our work in hypertension and coronary artery disease aligns with a renaissance occurring in cardiac pacing and balloon angioplasty, applying new innovations to enhance these foundational device-based interventions and create more potent therapeutic solutions. At our inaugural R&D day in June, we were excited to share our insights into this renaissance and the potential role we believe our lead programs – AVIM therapy and Virtue SAB – will play in improving outcomes for patients. We were delighted to host esteemed cardiology leaders Drs. David Kandzari and Vivek Reddy, who highlighted the critical unmet needs in high-risk hypertension and expressed their enthusiasm for the potential of AVIM therapy to transform care for these patient populations," stated David Hochman, founder, chief executive officer, and chairman of Orchestra BioMed. "As we look ahead to the second half of the year, we remain focused on driving patient enrollment in the BACKBEAT global pivotal study across the U.S. and EU, and look forward to providing key updates on our Virtue SAB program.”

Second Quarter 2024 and Recent Business Update

During its June 11th R&D Day, Orchestra BioMed provided an educational program on its lead asset, atrioventricular interval modulation (“AVIM”) therapy for the treatment of hypertension in high-risk patient populations. Orchestra BioMed has a strategic collaboration with Medtronic (NYSE: MDT) for the development and commercialization of AVIM therapy for the treatment of hypertension in patients indicated for a cardiac pacemaker. The replay of the webcast is available on the Orchestra BioMed website: link to webcast.

The event featured presentations from key opinion leaders, David Kandzari, M.D., FACC, FSCAI and Vivek Reddy, M.D., focused on the unmet hypertension treatment need in older high-risk patients, the AVIM therapy mechanism of action, clinical data from the MODERATO I and II studies, and design of the BACKBEAT study.

R&D Day Takeaways:

  • Cardiac pacing and balloon angioplasty are undergoing a renaissance: After decades of use in cardiovascular care, these foundational device-based interventions are evolving with the application of new therapies, like AVIM therapy and Virtue® Sirolimus AngioInfusion Balloon (“SAB”), that have the potential to substantially improve clinical outcomes in the treatment of hypertension and artery disease.
  • There is a significant unmet hypertension treatment need in older high-risk patients: Dr. Kandzari stated that despite the significant risks associated with uncontrolled hypertension, “nearly 75% of individuals in this country alone with hypertension do not achieve societal or guideline recommended treatment goals for the management of their blood pressure.”
  • Clinical and non-clinical evidence support the proposed AVIM therapy mechanism of action: Dr. Reddy explained how programmed pacing that modulates between short AV intervals and longer AV intervals is designed to utilize well-established cardiology principles to reduce blood pressure.
  • Clinical evidence from the MODERATO I and II studies demonstrate AVIM therapy substantially, immediately, and persistently reduced blood pressure: Dr. Reddy described the robust body of existing clinical data from the MODERATO I and II studies as “strong evidence” that this investigative therapy may be helpful in reducing blood pressure.
  • The BACKBEAT global pivotal study is rigorously designed to generate important safety and efficacy data for AVIM therapy in pacemaker-indicated patients with uncontrolled hypertension: Dr. Kandzari detailed the design and rationale of the BACKBEAT study, including the double-blind, randomized study’s 3-month primary efficacy and safety endpoints, additional and secondary endpoints, and novel patient enrollment pathways.

Additional Recent Highlights:

  • Continued focus on site activations and patient enrollment of the BACKBEAT study.
  • Company remains on track to provide strategic, clinical and regulatory updates on its Virtue SAB program in the second half of 2024.
  • Appointed cardiovascular device industry expert John Mack, former President and General Manager of Cardiac Surgery at Medtronic, to the Board of Directors.

Financial Results for the Second Quarter Ended June 30, 2024

  • Cash and cash equivalents and Marketable securities totaled $65.2 million as of June 30, 2024. Cash and cash equivalents increased in July 2024 by $15 million from net cash proceeds from the sale of Company Common Stock to a single institutional investor under the Open Market Sale Agreement. Expected operating cash runway 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 $10.3 million during the second quarter of 2024, compared with $10.5 million for the second quarter of 2023, with the primary driver of this decrease being reduced cash outflows for research and development during the second quarter.  
  • Revenue for the second quarter of 2024 was $0.8 million, compared with $0.9 million for the second quarter in 2023. The decrease was primarily due to decreased recognition of partnership revenues earned under the agreement with Terumo.
  • Research and development expenses for the second quarter of 2024 were $11.1 million, compared with $8.5 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 second quarter of 2024 were $6.5 million, compared with $5.3 million for the second quarter of 2023. The increase was primarily due to additional personnel, legal, insurance, finance and regulatory costs.
  • Net loss for the second quarter of 2024 was $16.0 million, or $0.45 per share, compared with a net loss of $12.0 million, or $0.35 per share, for 2023. Net loss for the second quarter of 2024 included non-cash stock-based compensation expense of $2.8 million as compared with $1.7 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 and expected proceeds from a revised Terumo agreement, the Company’s ability to conclude a favorable collaboration agreement with Terumo, the potential safety and efficacy of the Company’s product candidates 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 SEC on March 27, 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)
 
 June 30, December 31,
 2024
 2023
ASSETS     
CURRENT ASSETS:     
Cash and cash equivalents$23,713  $30,559 
Marketable securities 41,468   56,968 
Strategic investments, current portion    68 
Accounts receivable, net 80   99 
Inventory 70   146 
Prepaid expenses and other current assets 1,150   1,274 
Total current assets 66,481   89,114 
Property and equipment, net 1,235   1,279 
Right-of-use assets 1,331   1,555 
Strategic investments, less current portion 2,495   2,495 
Deposits and other assets 841   769 
TOTAL ASSETS$72,383  $95,212 
      
LIABILITIES AND STOCKHOLDERS’ EQUITY     
CURRENT LIABILITIES:     
Accounts payable$6,273  $2,900 
Accrued expenses and other liabilities 4,225   5,149 
Operating lease liability, current portion 350   649 
Deferred revenue, current portion 3,656   2,510 
Total current liabilities 14,504   11,208 
Deferred revenue, less current portion 12,652   14,923 
Operating lease liability, less current portion 1,102   1,038 
TOTAL LIABILITIES 28,258   27,169 
      
STOCKHOLDERS’ EQUITY     
Preferred stock, $0.0001 par value per share; 10,000,000 shares authorized; none issued or outstanding at June 30, 2024 and December 31, 2023.     
Common stock, $0.0001 par value per share; 340,000,000 shares authorized; 35,824,571 and 35,777,412 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively. 4   4 
Additional paid-in capital 322,441   316,903 
Accumulated other comprehensive loss (23)  (10)
Accumulated deficit (278,297)  (248,854)
TOTAL STOCKHOLDERS’ EQUITY 44,125   68,043 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY$72,383  $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 June 30,
 2024 2023
Revenue:     
Partnership revenue$628  $728 
Product revenue 150   187 
Total revenue 778   915 
Expenses:     
Cost of product revenues 44   54 
Research and development 11,126   8,499 
Selling, general and administrative 6,467   5,318 
Total expenses 17,637   13,871 
Loss from operations (16,859)  (12,956)
Other income (expense):     
Interest income, net 902   941 
Loss on fair value of strategic investments (23)  (31)
Total other income 879   910 
Net loss$(15,980) $(12,046)
Net loss per share     
Basic and diluted$(0.45) $(0.35)
Weighted-average shares used in computing net loss per share, basic and diluted 35,800,273   34,613,466 
Comprehensive loss     
Net loss$(15,980) $(12,046)
Unrealized loss on marketable securities (15)  (61)
Comprehensive loss$(15,995) $(12,107)
        

Investor Contact:
Bob Yedid
LifeSci Advisors
(516) 428-8577
Bob@lifesciadvisors.com   

Media Contact:
Kelsey Kirk-Ellis
Orchestra BioMed
(484) 682-4892
Kkirkellis@orchestrabiomed.com


FAQ

What were Orchestra BioMed's Q2 2024 financial results?

Orchestra BioMed reported revenue of $0.8 million, a net loss of $16.0 million ($0.45 per share), and cash and cash equivalents of $65.2 million as of June 30, 2024.

What is the status of Orchestra BioMed's BACKBEAT study for AVIM therapy?

Orchestra BioMed is continuing to focus on site activations and patient enrollment for the BACKBEAT global pivotal study, which is evaluating AVIM therapy for hypertension in pacemaker-indicated patients.

When will Orchestra BioMed provide updates on its Virtue SAB program?

The company expects to provide strategic, clinical, and regulatory updates on its Virtue SAB program in the second half of 2024.

How long is Orchestra BioMed's expected cash runway?

Based on internal forecasts and potential future proceeds, Orchestra BioMed expects its operating cash runway to extend into the second half of 2026.

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