NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO), a biomedical company, recently reported its first quarter 2023 financial results and provided a business update.
“The first quarter of 2023 was a transformational period for Orchestra BioMed marked by our successful entrance into the public markets. In the last year, we completed our BackBeat CNT strategic collaboration with Medtronic, the global leader in cardiac pacing therapies, and significantly strengthened our balance sheet with support from leading healthcare and strategic investors. With these accomplishments, we believe we have long-term capital resources to execute pivotal clinical studies for our two lead programs, BackBeat CNT and Virtue SAB,” stated David Hochman, Chairman, Co-founder and Chief Executive Officer of Orchestra BioMed. “We plan to start the BackBeat CNT and Virtue SAB pivotal studies this year and look forward to generating key data to support regulatory submissions for these high-impact therapeutic devices. It is an ideal time to be pursuing our innovative, partnership-enabled business model, and our team is focused on delivering significant value for our shareholders, physicians, and patients.”
- Completed successful business combination with Health Sciences Acquisition Corp 2 (“HSAC2”), a special purpose acquisition company sponsored by an affiliate of RTW Investments, LP (“RTW”), on January 26, 2023. Gross proceeds from the transaction were approximately $70 million and the transaction was supported by approximately $28 million in market purchases of HSAC2 stock and investments by funds managed by RTW affiliates and approximately $10 million in market purchases of HSAC2 stock by an affiliate of Medtronic plc (“Medtronic”).
- Strengthened senior leadership team with appointment of Avi Fischer, M.D., as Senior Vice President (SVP), Medical Affairs and Innovation; J.C. Simeon as SVP, Quality; George Papandreou, Ph.D., as General Manager and SVP, Focal Therapies; and Kunal Faldu as Vice President, Pharmaceutical Development.
- BackBeat Cardiac Neuromodulation Therapy (CNT™) – Hypertension in Pacemaker Patients
- Global pivotal study evaluating the efficacy and safety of BackBeat CNT in adult patients with hypertension who are indicated for a pacemaker on track to start in the second half of 2023
- Virtue® Sirolimus AngioInfusionTM Balloon (SAB) – Coronary Indications
- U.S. pivotal study evaluating Virtue SAB in adult patients with coronary ISR planned to start in the second half of 2023
- Additional Virtue SAB clinical studies in coronary ISR and small vessel disease planned in partnership with Terumo, the Company’s global strategic partner for development and commercialization of Virtue SAB
- Cash Position: As of March 31, 2023, Orchestra BioMed had cash and cash equivalents and marketable securities of $127.1 million, compared to $83.7 million as of December 31, 2022. The increase in cash was primarily due to the net proceeds provided by the closing of the business combination with HSAC2, less cash used in operating activities during the quarter and fees and expenses associated with the business combination. Based on current clinical development and other research and development plans and budget estimates, the Company anticipates that the cash and cash equivalents and marketable securities are sufficient to fund operations into 2026.
- Revenue: Orchestra BioMed recognized $1.2 million of revenue for the first quarter of 2023 compared to $0.9 million for the first quarter of 2022. The increase was primarily due to increased recognition of partnership revenues earned under the Terumo agreement.
- Research and Development Expenses: Research and development (R&D) expenses were $8.3 million for the first quarter of 2023 compared to $3.5 million for the first quarter of 2022. The increase was primarily due to additional costs associated with preparations for the launch of the Virtue SAB and BackBeat CNT pivotal clinical studies, as well as an increase of $0.5 million in non-cash stock-based compensation expense.
- Selling, General and Administrative Expenses: Selling, general and administrative expenses were $4.4 million for the first quarter of 2023, compared to $2.5 million for the first quarter of 2022. The increase was primarily due to additional personnel costs, legal, insurance and finance costs, transaction costs incurred related to the closing of the business combination and included an increase of $0.9 million in non-cash stock-based compensation expense.
- Other Income (Expense): Other income was $0.6 million for the first quarter of 2023, compared to other expense of $0.6 million for the first quarter of 2022. Interest income (expense), net, increased by $1.1 million from the first quarter of 2022 due to the higher cash balance and an increase in interest rates.
- Net Loss: Net loss was $10.9 million for the first quarter of 2023, or $0.40 per share, compared to a net loss of $5.7 million, or $0.62 per share, for the same period in 2022. The net loss for the first quarter of 2023 includes $1.8 million in non-cash stock-based compensation expense and loss on fair value adjustment of warrant liability as compared to $0.2 million for the first quarter of 2022.
For further information and additional details, visit www.orchestrabiomed.com.
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