Orchestra BioMed (US:OBIO)2025-11-10 21:06Financial Performance - As of September 30, 2025, Orchestra BioMed has raised a cumulative $334.9 million in gross proceeds, with net losses of $58.9 million and $44.9 million for the nine months ended September 30, 2025 and 2024, respectively[202]. - The accumulated deficit of Orchestra BioMed as of September 30, 2025, stands at $368.8 million[202]. - Net loss for the nine months ended September 30, 2025, was $58.946 million, a decrease of $14.077 million or 31% from a net loss of $44.869 million in 2024[244]. - Net losses for the nine months ended September 30, 2025, were $58.9 million, compared to $44.9 million for the same period in 2024, reflecting an increase of approximately 31%[266]. - Cash and cash equivalents totaled $95.8 million, consisting of $42.0 million in cash and cash equivalents and $53.8 million in marketable securities[266]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $46.7 million, compared to $37.0 million for the same period in 2024, indicating a 26% increase in cash outflow[274][276]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $75.7 million, significantly higher than $15.2 million for the same period in 2024[279][280]. Research and Development - The company has focused on research and development, primarily funding operations through stock issuances and proceeds from the Business Combination[202]. - The company expects research and development expenses to increase in absolute dollars as it continues to develop new products and enhance existing technologies[236]. - Research and development expenses rose by $9.5 million, or approximately 30%, to $41.4 million for the nine months ended September 30, 2025, from $31.8 million in 2024[251]. - Research and development expenses increased by $2.4 million, or approximately 21%, to $14.0 million for the three months ended September 30, 2025[262]. - Research and development costs are estimated at each reporting date based on discussions with internal personnel and service providers regarding the progress of trials[302]. - Nonrefundable advance payments for research and development activities are deferred and capitalized until the related goods or services are accepted or performed[302]. Clinical Trials and Studies - The company is conducting the BACKBEAT study, enrolling up to 500 patients with uncontrolled hypertension, expected to complete enrollment by mid-2026[199]. - The Virtue Trial, comparing Virtue SAB to Boston Scientific's AGENT drug-coated balloon, is expected to enroll 740 patients in the U.S., with completion planned for mid-2027[204]. - An exclusive license and collaboration agreement with Medtronic for AVIM Therapy is in place, targeting uncontrolled hypertension patients indicated for a cardiac pacemaker[199]. Revenue and Partnership Agreements - The company has recognized product revenues from FreeHold's intracorporeal organ retractors, with revenues recognized upon shipment to customers[232]. - Partnership revenue increased by $192,000, or approximately 10%, to $2.1 million for the nine months ended September 30, 2025, compared to $1.9 million for the same period in 2024[245]. - Total revenue for the nine months ended September 30, 2025, was $2.565 million, an increase of $180,000 or 8% from $2.385 million in 2024[244]. - The company may sell up to $100.0 million of shares of common stock under a sales agreement to meet liquidity needs[270]. - The Terumo Agreement was terminated on October 24, 2025, which may impact future partnership revenues[288]. - The company has not recognized any revenue under the Medtronic Agreement through September 30, 2025, indicating ongoing development efforts[299]. Expenses and Financial Obligations - Selling, general and administrative expenses increased by $1.6 million, or approximately 9%, to $19.6 million for the nine months ended September 30, 2025[253]. - Selling, general and administrative expenses increased by $1.4 million, or approximately 25%, to $7.1 million for the three months ended September 30, 2025[264]. - The company anticipates an increase in selling, general, and administrative expenses as it expands operations as a public company[237]. - The company has a secured term loan facility of up to $50.0 million, with the first tranche of $15.0 million drawn on November 6, 2024[240]. - The company entered into a Royalty Purchase Agreement with Ligand Pharmaceuticals for $35.0 million, granting Ligand tiered royalty payments based on worldwide net product sales[239]. Stock and Compensation - Stock-based compensation for the three months ended September 30, 2025, was $3.0 million, compared to $2.4 million for the same period in 2024, reflecting a 25% increase[308]. - For the nine months ended September 30, 2025, stock-based compensation totaled $9.2 million, up from $7.7 million in 2024, indicating an increase of approximately 19.5%[308]. - As of September 30, 2025, the company had approximately $16.2 million of total unrecognized stock-based compensation, expected to be recognized over a weighted-average period of 2.3 years[308]. Company Status and Compliance - The company expects to lose its emerging growth company status on December 31, 2025, but will continue as a smaller reporting company[315]. - The company is not required to comply with auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act as long as annual revenue is less than $100 million and market value of common stock held by non-affiliates is below $700 million[315]. - The fair value of stock options is estimated using the Black-Scholes option-pricing model, with subjective inputs requiring significant management judgment[307].