Orchestra BioMed Holdings, Inc. reported a net loss of $61.0 million for the year ended December 31, 2024, compared to a net loss of $49.1 million in 2023. Total revenue decreased by 4% to $2.6 million, primarily due to a decrease in partnership revenue from $2.1 million to $2.0 million and a slight decrease in product revenue. Research and development expenses increased by 27% to $42.8 million, reflecting increased investment in the BACKBEAT and Virtue SAB programs. Selling, general, and administrative expenses rose by 18% to $23.9 million, largely attributed to increased stock-based compensation and public company operating costs.
Significant changes compared to the previous fiscal year include a $15 million increase in debt financing through a loan agreement with Hercules Capital, and a decrease in partnership revenue due to changes in the estimated costs to complete the Terumo Agreement. The company also noted a loss on fair value adjustment of warrant liability of $294,000 in 2023, related to the reclassification of warrants to equity upon the business combination. In 2024, a loss on fair value of strategic investments of $68,000 was recorded, primarily due to the liquidation of Motus GI.
Strategic developments during the year included the FDA granting an investigational device exemption (IDE) approval for the BACKBEAT study in September 2023, with the first patient enrolled in January 2024. An amendment to the BACKBEAT study protocol was implemented to improve patient engagement and expand enrollment. The company also received conditional IDE approval for the Virtue ISR-US pivotal study in August 2023, but is now planning an updated study design following the FDA approval of a competitor's product. The company is pursuing mediation with Terumo regarding amendments to their existing agreement.
Key operational developments included the implementation of an updated protocol for the BACKBEAT study, aiming for enrollment completion in the first half of 2026. The company plans to initiate enrollment in the revised Virtue ISR-US study in the second half of 2025, pending FDA approval of an amended IDE. As of December 31, 2024, Orchestra BioMed had 70 employees. The company also highlighted its partnership-enabled business model, focusing on collaborations with established medical device companies like Medtronic and Terumo to share the risks and rewards of product development and commercialization.
The company acknowledged substantial doubt about its ability to continue as a going concern due to insufficient cash resources to fund operations for the next twelve months. The company plans to pursue additional funding through equity offerings, loan drawdowns, and potential monetization of royalty streams. The company also discussed various risks, including those related to clinical trial outcomes, regulatory approvals, competition, intellectual property protection, and reliance on third-party partners.
About Orchestra BioMed Holdings, Inc.
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