Orchestra BioMed Holdings, Inc.
Business
Orchestra BioMed Holdings, Inc. is a biomedical innovation company that accelerates medical technologies to patients via risk‑reward sharing partnerships with leading medical device companies. It develops bioelectronic therapies (AVIM and CNT‑HF), an interventional drug/device combination (Virtue Sirolimus AngioInfusion Balloon and SirolimusEFR), and procedure-support systems (FreeHold retractors, Pure‑Vu cleansing system). The company operates through Bioelectronic Therapies and Interventional Therapies segments and pursues strategic collaborations and licensing with firms such as Medtronic and Terumo. It advances clinical development, regulatory approvals and commercialization across the United States, Europe, Japan and other international markets through partner-led manufacturing and distribution.
Summary from filing dated 2025-03-31
Financials
Consolidated Statement of Income
| Concept | Trend | FY 2025 2025-12-31 | FY 2024 2024-12-31 | FY 2023 2023-12-31 | FY 2022 2022-12-31 | FY 2021 2021-12-31 |
|---|---|---|---|---|---|---|
| Total revenue | 33 | 3 | 3 | 4 | — | |
| Cost of product revenues | 190,000 | 204,000 | 186,000 | 211,000 | — | |
| Research and development | 58 | 43 | 34 | 22 | — | |
| Selling, general and administrative | 27 | 24 | 20 | 14 | — | |
| Total expenses | 85 | 67 | 54 | 36 | — | |
| Loss from operations | −52 | −64 | −52 | −33 | −394,756 | |
| Interest (expense) income, net | −1 | 3 | 4 | — | — | |
| Change in the fair value of derivative liability | 254,000 | — | — | — | — | |
| Loss on fair value of strategic investments | — | −68,000 | −18,000 | 1 | — | |
| Other expense | — | −11,000 | — | — | — | |
| Total other (expense) income | −894,000 | 3 | 2 | −951,000 | — | |
| Net loss | −53 | −61 | −49 | −34 | −378,753 | |
| Adjustment to carrying value of Series A Preferred Stock | −254,000 | — | — | — | — | |
| Net loss attributable to common stockholders | −53 | −61 | — | — | — | |
| Basic (in dollars per share) | −1.11 | −1.66 | −1.48 | −2.24 | −0.02 | |
| Diluted (in dollars per share) | −1.11 | −1.66 | −1.48 | −2.24 | −0.02 | |
| Weighted-average shares used in computing net loss attributable to common stockholders per share, basic (in shares) | 48 | 37 | 33 | 15 | 20 | |
| Weighted-average shares used in computing net loss attributable to common stockholders per share, diluted (in shares) | 48 | 37 | 33 | 15 | 20 | |
| Unrealized gain on marketable securities | 8,000 | 62,000 | −2,000 | −8,000 | — | |
| Comprehensive loss | −53 | −61 | −49 | −34 | — |
Consolidated Balance Sheet
| Concept | Trend | FY 2025 2025-12-31 | FY 2024 2024-12-31 | FY 2023 2023-12-31 | FY 2022 2022-12-31 | FY 2021 2021-12-31 |
|---|---|---|---|---|---|---|
| Cash and cash equivalents | 35 | 22 | 31 | 20 | 2 | |
| Marketable securities | 72 | 45 | 57 | 64 | — | |
| Accounts receivable, net | 95,000 | 92,000 | 99,000 | 96,000 | — | |
| Inventory | 310,000 | 173,000 | 146,000 | 276,000 | — | |
| Prepaid expenses and other current assets | 994,000 | 2 | 1 | 533,000 | — | |
| Total current assets | 108 | 69 | 89 | 85 | 2 | |
| Property and equipment, net | 2 | 1 | 1 | 1 | — | |
| Right-of-use assets | 1 | 2 | 2 | 2 | — | |
| Strategic investments | 2 | 2 | — | — | — | |
| Deposits and other assets | 1 | 1 | 769,000 | 5 | — | |
| TOTAL ASSETS | 115 | 76 | 95 | 96 | 162 | |
| Accounts payable | 6 | 5 | 3 | 4 | 1,388 | |
| Accrued expenses and other liabilities | 10 | 6 | 5 | 5 | 14,151 | |
| Operating lease liability, current portion | 751,000 | 550,000 | 649,000 | 697,000 | — | |
| Deferred revenue, current portion | — | 4 | 3 | 6 | — | |
| Total current liabilities | 17 | 16 | 11 | 19 | 165,539 | |
| Deferred revenue, less current portion | — | 11 | 15 | 13 | — | |
| Royalty purchase agreement | 16 | — | — | — | — | |
| Loan payable | 14 | 14 | — | 9 | — | |
| Derivative liability | 3 | — | — | — | — | |
| Operating lease liability, less current portion | 936,000 | 2 | 1 | 2 | — | |
| Other long-term liabilities | 308,000 | 40,000 | — | 196,000 | — | |
| TOTAL LIABILITIES | 51 | 43 | 27 | 43 | 6 | |
| Series A Preferred Stock, $0.0001 par value per share; 200,000 issued and outstanding at December 31, 2025 and 0 issued and outstanding at December 31, 2024; aggregate liquidation preference of $20,000 at December 31, 2025 | 10 | — | — | — | — | |
| Preferred stock, $0.0001 par value, 10,000,000 shares authorized; | — | — | — | — | — | |
| Common stock, $0.0001 par value per share; 340,000,000 shares authorized; 57,032,963 and 38,194,442 shares issued and outstanding as of December 31, 2025 and December 31, 2024, respectively. | 6,000 | 4,000 | 4,000 | 2,000 | 445 | |
| Additional paid-in capital | 416 | 343 | 317 | 252 | — | |
| Accumulated other comprehensive income | 60,000 | 52,000 | −10,000 | −8,000 | — | |
| Accumulated deficit | −363 | −310 | −249 | −200 | −4 | |
| TOTAL STOCKHOLDERS' EQUITY | 54 | 33 | 68 | 53 | −20 | |
| TOTAL LIABILITIES, SERIES A PREFERRED STOCK AND STOCKHOLDERS' EQUITY | 115 | 76 | 95 | 96 | 162 |
Consolidated Statement of Cash Flows
| Concept | Trend | FY 2025 2025-12-31 | FY 2024 2024-12-31 | FY 2023 2023-12-31 | FY 2022 2022-12-31 | FY 2021 2021-12-31 |
|---|---|---|---|---|---|---|
| Net loss | −53 | −61 | −49 | −34 | — | |
| Depreciation and amortization | 327,000 | 308,000 | 287,000 | 222,000 | — | |
| Stock-based compensation | 12 | 11 | 8 | 3 | — | |
| Acquired in-process research and development | 0 | 1 | 0 | — | — | |
| Non-cash interest expense on liability related to the royalty purchase agreement | 2 | — | — | — | — | |
| Accretion and interest related to marketable securities | −811,000 | −2 | −4 | −600,000 | — | |
| Non-cash lease expense | 607,000 | 654,000 | 632,000 | 571,000 | — | |
| Amortization of deferred financing fees | 215,000 | 31,000 | 112,000 | 163,000 | — | |
| Other | — | 11,000 | — | — | — | |
| Accounts receivable | −3,000 | 22,000 | −3,000 | 25,000 | — | |
| Inventory | −137,000 | −28,000 | 131,000 | −208,000 | — | |
| Prepaid expenses and other assets | 880,000 | −1 | −781,000 | −439,000 | — | |
| Accounts payable, accrued expenses and other liabilities | 5 | 3 | 145,000 | 3 | — | |
| Operating lease liabilities - current and non-current | −550,000 | −652,000 | −693,000 | −319,000 | — | |
| Deferred revenue | −15 | −2 | −2 | −3 | — | |
| Net cash used in operating activities | −49 | −51 | −46 | −29 | −272,362 | |
| Purchases of property and equipment | −489,000 | −289,000 | −78,000 | −591,000 | — | |
| Sales of marketable securities | 50 | 87 | 153 | — | — | |
| Purchases of marketable securities | −76 | −73 | −142 | −63 | — | |
| Asset acquisition, net of cash acquired | — | −602,000 | — | — | — | |
| Net cash (used in) provided by investing activities | −27 | 13 | 11 | −64 | — | |
| Proceeds from sale of common stock and pre-funded warrants, net of issuance costs | 58 | — | — | — | — | |
| Proceeds from the royalty purchase agreement | 20 | — | — | — | — | |
| Proceeds from issuance of Series A preferred stock | 13 | — | — | — | — | |
| Repayment of royalty liability | −972,000 | — | — | — | — | |
| Proceeds from Hercules term loan | — | 15 | — | 10 | — | |
| Proceeds from At-The-Market offering, net of issuance costs | 2 | 15 | — | — | — | |
| Proceeds from exercise of stock options | 91,000 | 240,000 | 231,000 | 121,000 | — | |
| Restricted stock units withheld for tax | −2 | −550,000 | — | — | — | |
| Deferred financing costs | −1 | −554,000 | — | — | — | |
| Net cash provided by financing activities | 88 | 29 | 46 | 103 | — | |
| Net increase (decrease) in cash and cash equivalents | 12 | −8 | 11 | 10 | −272,362 | |
| Interest | 1 | 102,000 | 1 | 1 | — | |
| Operating lease right-of-use asset obtained in exchange for new operating lease liabilities | — | 1 | — | — | — | |
| Increase in accounts payable, accrued expenses and other liabilities related to fixed assets | 169,000 | — | — | — | — | |
| Common stock issued pursuant to asset acquisition | — | 352,000 | — | — | — | |
| Warrants issued pursuant to debt financing | 239,000 | 185,000 | 66,000 | — | — | |
| Warrants issued pursuant to the royalty purchase agreement | 3 | — | — | — | — |