NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) this week reported its third quarter 2023 financial results and provided a business update.
“This past quarter marked two major regulatory milestones for Orchestra BioMed, with the FDA granting IDE approval for pivotal studies for both BackBeat CNT (AVIM therapy) and Virtue SAB. We are excited to initiate enrollment of the BACKBEAT pivotal study imminently, taking a critical step closer to enabling Medtronic, our strategic partner, to deliver this highly innovative blood pressure treatment to patients,” stated David Hochman, Chairman, Chief Executive Officer and Founder of Orchestra BioMed. “We believe the design of the BACKBEAT pivotal study positions us to report topline data from this landmark study within the timeframe of our anticipated operating cash runway.”
“We are actively engaged with our colleagues at Terumo with the goal of updating our Virtue SAB strategic agreement and aligning our plans to advance this differentiated technology through pivotal studies and to the market,” Mr. Hochman continued. “As the only non-coated balloon angioplasty system that enables protected delivery of extended release sirolimus directly to target arterial lesions, Virtue SAB has the potential to redefine the class of drug-eluting balloons, which are emerging as a preferred solution for the treatment of coronary artery disease.”
Lead Program
BackBeat CNTTM (atrioventricular interval modulation (AVIM) therapy): large global opportunity for treating hypertension in targeted populations
- Dual-chamber pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications
- BACKBEAT pivotal study evaluating the efficacy and safety of AVIM therapy in hypertensive pacemaker patients on track to start by the end of 2023.
- Study to enroll up to 500 patients across approximately 80 sites globally, with a target for completion of enrollment in mid-2025.
- High-risk hypertension (non-pacing) and heart failure patients
- Orchestra BioMed continues to explore future opportunities to utilize AVIM therapy for high-risk, older patients with hypertension and co-morbidities that are not already indicated for a pacemaker, as well as to develop cardiac neuromodulation therapy specifically for the treatment of heart failure (CNT-HF).
Pipeline Program
Virtue® Sirolimus AngioInfusionTM Balloon (SAB): large global opportunity for treatment of coronary and peripheral artery disease with differentiated “leave nothing behind” solution
- Virtue SAB – Coronary Indications
- U.S. Food and Drug Administration (“FDA”) granted IDE approval with conditions to initiate Virtue ISR-US pivotal study evaluating Virtue SAB in adult patients with coronary ISR.
- Initiation of Virtue ISR-US study targeted for 2024 pending ongoing negotiations with Terumo to restructure existing strategic partnership agreement.
- Planned Japanese Pharmaceutical and Medical Devices Agency submissions are on track to support Japanese registrational studies of Virtue SAB in coronary ISR and coronary small vessel disease.
Financial Results for the Third Quarter Ended September 30, 2023
- Cash and cash equivalents and Marketable securities totaled $108.5 million as of September 30, 2023.
- Operating cash runway extended into the second half of 2026 based on internally prepared forecast reflecting updated operating priorities.
- Net cash used in operating activities and for the purchase of fixed assets was $10.3 million during the third quarter of 2023, compared with $7.5 million for the same period in 2022, with the primary drivers of increased spending being costs associated with preparation for the initiation of the BACKBEAT pivotal study as well as expenses associated with being a public company.
- Revenue for the third quarter of 2023 was $0.4 million, compared with $1.2 million for the same period in 2022. The decrease was primarily due to decreased recognition of partnership revenues earned under the agreement with Terumo.
- Research and development expenses for the third quarter of 2023 were $8.6 million, compared with $5.9 million for the same period in 2022. The increase was primarily due to additional costs associated with preparation for the initiation of the BACKBEAT pivotal study.
- Selling, general and administrative expenses for the third quarter of 2023 were $6.3 million, compared with $5.3 million for the same period in 2022. The increase was primarily due to additional personnel costs, legal, insurance and finance costs, and additional costs related to being a public company.
- Net loss for the third quarter of 2023 was $13.3 million, or $0.38 per share, compared with a net loss of $10.3 million, or $0.51 per share, for the same period in 2022. Net loss for the third quarter of 2023 included non-cash stock-based compensation expense of $3.5 million, compared with $2.2 million for the same period in 2022.
For more information, visit www.orchestrabiomed.com.
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