Orchestra BioMed Holdings, Inc.

Previous wording

We are a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Our partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products we develop. We are led by a highly accomplished, multidisciplinary management team and a board of directors with extensive experience in all phases of therapeutic device development. Our business was formed in 2018 by assembling a pipeline of multiple late-stage clinical product candidates originally developed by our founding team.

Current wording

We are a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing collaborations with market-leading global medical device companies. Our partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products we develop. We are led by a highly accomplished, multidisciplinary management team and a board of directors with extensive experience in all phases of therapeutic device development. Our business was formed in 2018 by assembling a pipeline of multiple late-stage clinical product candidates originally developed by our founding team.

Previous wording

AVIM Therapy is a bioelectronic treatment for hypertension (“HTN”), the leading risk factor for death worldwide, and is designed to be delivered by a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. We have an exclusive license and collaboration agreement with Medtronic Inc. (an affiliate of Medtronic plc) (“Medtronic”), one of the largest medical device companies in the world and the global leader in cardiac pacing therapies, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled HTN in patients indicated for a cardiac pacemaker. We are actively conducting a double-blind, randomized, global pivotal trial (the “BACKBEAT Trial”), enrolling 284 evaluable randomized patients with uncontrolled HTN who are indicated for a dual-chamber pacemaker, with enrollment currently targeted to be completed by the end of the third quarter of 2026. Assuming primary endpoints are met, we and Medtronic intend to submit primary endpoint data as a late-breaking clinical trial presentation at a major cardiovascular conference in the second quarter of 2027, followed by marketing application submissions to the FDA and global regulatory agencies. AVIM Therapy has received FDA Breakthrough Device Designations (“BDDs”) for the pacemaker indicated group studied in the BACKBEAT Trial and an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk.

Current wording

AVIM Therapy is a bioelectronic treatment for hypertension (“HTN”), the leading risk factor for death worldwide, and is designed to be delivered by a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. We have an exclusive license and strategic collaboration agreement with Medtronic Inc. (an affiliate of Medtronic plc) (“Medtronic”), one of the largest medical device companies in the world and the global leader in cardiac pacing therapies, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled HTN in patients indicated for a cardiac pacemaker. We are actively conducting a double-blind, randomized, global pivotal trial (the “BACKBEAT Trial”). As of October 31, 2026, we enrolled 349 randomized patients with uncontrolled HTN who are indicated for a dual-chamber pacemaker. Assuming primary endpoints are met, we and Medtronic plan to submit primary endpoint data as a late-breaking clinical trial presentation at Heart Rhythm 2027 in May, the premier global scientific meeting for electrophysiologists and cardiologists who implant pacemakers and care for pacemaker-indicated patients. Following this, Medtronic is expected to submit a Premarket Approval application supplement to the FDA, as well as applications to other global regulatory agencies. AVIM Therapy has received two FDA Breakthrough Device Designations (“BDDs”).

Previous wording

Virtue SAB is a highly differentiated, first-of-its-kind non-coated drug delivery angioplasty system designed to deliver a large liquid dose of our proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted BDD by the FDA for the treatment of coronary in-stent restenosis, coronary small vessel disease and below-the-knee peripheral artery disease, in each case, within specified parameters. We have initiated patient enrollments in the Virtue SAB in the Treatment of Coronary In-Stent Restenosis (“ISR”) Trial (the “Virtue Trial”) for our U.S. investigational device exemption (“IDE”) pivotal study randomizing Virtue SAB versus Boston Scientific Corporation’s AGENT™ drug-coated balloon. Designed to support regulatory approval of Virtue SAB, the Virtue Trial is expected to enroll 740 patients in the United States with enrollment completion currently planned for 2027. We cannot provide assurance that we will be able to complete enrollment of the BACKBEAT Trial or the Virtue Trial in the timeframes we anticipate.

Current wording

Virtue SAB is a highly differentiated, first-of-its-kind, non-coated drug delivery AngioInfusion balloon system designed to infuse a large liquid dose of our proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted BDD by the FDA for the treatment of coronary in-stent restenosis, coronary small vessel disease and below-the-knee peripheral artery disease, in each case, within specified parameters. We are actively enrolling patients in the Virtue SAB in the Treatment of Coronary In-Stent Restenosis (“ISR”) Trial (the “Virtue Trial”) for our global investigational device exemption (“IDE”) pivotal trial comparing Virtue SAB head-to-head with Boston Scientific Corporation’s commercially available AGENT™ paclitaxel-coated balloon. Designed to support regulatory approval of Virtue SAB, the Virtue Trial is expected to enroll 740 patients in the United States with enrollment expected to be completed by the end of 2027. We cannot provide assurance that we will be able to complete enrollment of the Virtue Trial in the timeframe we anticipate.

Previous wording

Since Orchestra BioMed, Inc.’s inception, we have devoted the substantial majority of our resources to research and development and clinical activities in support of our product development and collaboration efforts. We have funded our operations primarily through the issuance of our common stock, convertible preferred stock, and warrants, as well as proceeds from the Business Combination, our prior Terumo Agreement (as defined below) and the Termination and ROFR Agreement (as defined below), borrowings under debt arrangements, the sale of future revenues, sale of strategic investments, and, to a lesser extent, product revenue from our subsidiary, FreeHold Surgical, LLC. (“FreeHold”). We had $110.0 million in cash and cash equivalents and marketable securities at June 30, 2026, comprised of $20.5 million in cash and cash equivalents and $89.5 million in marketable securities. We have incurred net losses each year since inception. Our net losses were $44.4 million and $38.1 million for the six months ended June 30, 2026 and 2025, respectively. We expect to continue to incur significant losses for the foreseeable future. As of June 30, 2026, we had an accumulated deficit of $407.0 million.

Current wording

Since Orchestra BioMed, Inc.’s inception, we have devoted the substantial majority of our resources to research and development and clinical activities in support of our product development and collaboration efforts. We have funded our operations primarily through the issuance of our common stock, convertible preferred stock, and warrants, as well as proceeds from the Business Combination, our prior Terumo Agreement (as defined below) and the Termination and ROFR Agreement (as defined below), borrowings under debt arrangements, the sale of future revenues, sale of strategic investments, and, to a lesser extent, product revenue from our subsidiary, FreeHold Surgical, LLC (“FreeHold”). We had $101.9 million in cash and cash equivalents and marketable securities at September 30, 2026, comprised of $27.8 million in cash and cash equivalents and $74.1 million in marketable securities. We have incurred

Previous wording

Previously, our partnership revenues related to our former distribution agreement with Terumo Corporation (“Terumo Corporation”) and Terumo Medical Corporation (“TMC” and, collectively with Terumo Corporation, “Terumo”) for global development and commercialization of Virtue SAB in coronary and peripheral vascular indications (the “Terumo Agreement”). In future periods, partnership revenues may include revenues related to the Exclusive License and Collaboration Agreement, dated as of June 30, 2022, by and among, Orchestra BioMed, Inc., BackBeat Medical, LLC and Medtronic, discussed in Note 3 –“Medtronic Agreement” to the Consolidated Financial Statements.

Current wording

commercialization of Virtue SAB in coronary and peripheral vascular indications (the “Terumo Agreement”). In future periods, partnership revenues may include revenues related to the Exclusive License and Collaboration Agreement, dated as of June 30, 2022, by and among, Orchestra BioMed, Inc., BackBeat Medical, LLC and Medtronic, discussed in Note 3 –“Medtronic Agreement” to the Consolidated Financial Statements.

Previous wording

Research and development costs are expensed as incurred. Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical studies. In the future, we expect research and development expenses to increase in absolute dollars as we continue to develop new products, enhance existing products and technologies, initiate clinical studies, manufacture drug supply for internal research and development and clinical trial supply and perform activities related to obtaining additional regulatory approvals. We do not track expenses by product candidate, unless tracking such expenses is required pursuant to the revenue recognition model for a collaborative arrangement.

Current wording

Research and development costs are expensed as incurred. Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical studies. In the future, we expect research and development expenses may increase in absolute dollars as we continue to develop new products, enhance existing products and technologies, initiate clinical studies, manufacture drug supply for internal research and development and clinical trial supply and perform activities related to obtaining additional regulatory approvals. We do not track expenses by product candidate, unless tracking such expenses is required pursuant to the revenue recognition model for a collaborative arrangement.

Previous wording

On July 31, 2025, we entered into a revenue participation right purchase and sale agreement (the “Royalty Purchase Agreement”) with Ligand Pharmaceuticals Incorporated (“Ligand”). Under the terms of the Royalty Purchase Agreement, in exchange for payment of $35.0 million (the “Investment Amount”), less certain reimbursable expenses, Ligand acquired the right to receive tiered royalty payments from us (the “Royalty Interest”) with respect to revenue (including certain licensing revenue) received by us in a calendar year in connection with worldwide net product sales, or other product revenue received by, by us and our licensees (“Annual Net Sales”) of (a) AVIM Therapy (the “Primary Product”) and (b) Virtue SAB (the “Secondary Product” and together with the Primary Product, the “Products”) in the field of coronary artery treatment. Our estimate of this total interest expense associated with the Royalty Interest resulted in an effective annual interest rate of approximately 21.2% as of June 30, 2026. This estimate contains significant assumptions that impact both the amount recorded at execution and the interest expense that will be recognized over the royalty period. We will periodically assess the estimated amounts due and payable to Ligand and to the extent the amount or timing of such payments is materially different than the original estimates, an adjustment will be recorded prospectively to increase or decrease interest expense. There are a number of factors that could materially affect the amount and timing of the royalty payments to be paid by us to Ligand and, correspondingly, the amount of interest expense recorded by us.

Current wording

On July 31, 2025, we entered into a revenue participation right purchase and sale agreement (the “Royalty Purchase Agreement”) with Ligand Pharmaceuticals Incorporated (“Ligand”). Under the terms of the Royalty Purchase Agreement, in exchange for payment of $35.0 million (the “Investment Amount”), less certain reimbursable expenses, Ligand acquired the right to receive tiered royalty payments from us (the “Royalty Interest”) with respect to revenue (including certain licensing revenue) received by us in a calendar year in connection with worldwide net product sales, or other product revenue received by, by us and our licensees (“Annual Net Sales”) of (a) AVIM Therapy (the “Primary Product”) and (b) Virtue SAB (the “Secondary Product” and together with the Primary Product, the “Products”) in the field of coronary artery treatment. Our estimate of this total interest expense associated with the Royalty Interest resulted in an effective annual interest rate of approximately 21.3% as of September 30, 2026. This estimate contains significant assumptions that impact both the amount recorded at execution and the interest expense that will be recognized over the royalty period. We will periodically assess the estimated amounts due and payable to Ligand and to the extent the amount or timing of such payments is materially different than the original estimates, an adjustment will be recorded prospectively to increase or decrease interest expense. There are a number of factors that could materially affect the amount and timing of the royalty payments to be paid by us to Ligand and, correspondingly, the amount of interest expense recorded by us.

Previous wording

We recognize interest expense using the effective interest method over the estimated term of the arrangement. The effective interest rate is based on our estimate of the timing and amount of future payments expected to be made under the arrangement. The total interest expense associated with the Medtronic Note resulted in an effective interest rate of 13.2% as of June 30, 2026. We will periodically assess the estimated amounts due and payable to Medtronic and to the extent the amount or timing of such payments is materially different than the original estimates, an adjustment will be recorded prospectively to the condensed consolidated statements of operations and comprehensive loss.

Current wording

We recognize interest expense using the effective interest method over the estimated term of the arrangement. The effective interest rate is based on our estimate of the timing and amount of future payments expected to be made under the arrangement. The total interest expense associated with the Medtronic Note resulted in an effective interest rate of 15.2% as of September 30, 2026. We will periodically assess the estimated amounts due and payable to Medtronic and to the extent the amount or timing of such payments is materially different than the original estimates, an adjustment will be recorded prospectively to the condensed consolidated statements of operations and comprehensive loss.

Previous wording

The gain on sale of strategic investments represents a change in the preferred shares and convertible notes of Vivasure Medical Limited (“Vivasure”), a privately-held company and related party, and fair value of our investment in common stock holdings of a previously publicly-held company. On January 9, 2026, Haemonetics Corporation, a global medical technology company focused on delivering innovative solutions designed to improve patient outcomes, announced its acquisition of Vivasure. Vivasure was a strategic investment of ours prior to its acquisition. In connection with the closing of the transaction, we recognized a gain on the sale of strategic investments of

Current wording

The gain on sale of strategic investments represents a change in the preferred shares and convertible notes of Vivasure Medical Limited (“Vivasure”), a privately-held company and related party, and fair value of our investment in common stock holdings of a previously publicly-held company. On January 9, 2026, Haemonetics Corporation, a global medical technology company focused on delivering innovative solutions designed to improve patient outcomes, announced its acquisition of Vivasure. Vivasure was a strategic investment of

Previous wording

$2.3 million. We may receive additional proceeds in the future associated with revenue earnouts based on the achievement of certain milestones.

Current wording

ours prior to its acquisition. In connection with the transaction, we recognized a gain on the sale of strategic investments of $8.4 million. We may receive additional proceeds in the future associated with revenue earnouts based on the achievement of certain milestones.

Previous wording

The following table presents our statement of operations data for the six months ended June 30, 2026 and 2025, and the dollar and percentage change between the two periods (in thousands):

Current wording

The following table presents our statement of operations data for the nine months ended September 30, 2026 and 2025, and the dollar and percentage change between the two periods (in thousands):

Previous wording

Partnership revenue decreased by $1.4 million, or 100%, in the six months ended June 30, 2026 from $1.4 million for the six months ended June 30, 2025. Partnership revenue related to the recognition of the combined performance obligation for the license granted to Terumo and the ongoing research and development services over the estimated performance period for the Virtue SAB coronary ISR indication, using a proportional performance model, based on the costs incurred relative to the total estimated costs of the research and development services. Prior to the termination of the Terumo Agreement, as of each quarterly reporting date, we evaluated our estimates of the total costs expected to be incurred through the completion of the combined performance obligation and updated our estimates as necessary. On October 24, 2025, we and Terumo entered into a termination and right of first refusal agreement (the “Termination and ROFR Agreement”), which superseded and terminated the Terumo Agreement, and we no longer have any performance obligations under the Terumo Agreement.

Current wording

Partnership revenue decreased by $2.1 million, or 100%, in the nine months ended September 30, 2026 from $2.1 million for the nine months ended September 30, 2025. Partnership revenue related to the recognition of the combined performance obligation for the license granted to Terumo and the ongoing research and development services over the estimated performance period for the Virtue SAB coronary ISR indication, using a proportional performance model, based on the costs incurred relative to the total estimated costs of the research and development services. Prior to the termination of the Terumo Agreement, as of each quarterly reporting date, we evaluated our estimates of the total costs expected to be incurred through the completion of the combined performance obligation and updated our estimates as necessary. On October 24, 2025, we and Terumo entered into a termination and right of first refusal agreement (the “Termination and ROFR Agreement”), which superseded and terminated the Terumo Agreement, and we no longer have any performance obligations under the Terumo Agreement.

Previous wording

For the six months ended June 30, 2025, the expenses incurred related to the Terumo Agreement were $6.8 million. The estimated total costs associated with the Terumo Agreement through completion as of June 30, 2025 were similar compared to the estimates as of December 31, 2024.

Current wording

For the nine months ended September 30, 2025, the expenses incurred related to the Terumo Agreement were $10.1 million. The estimated total costs associated with the Terumo Agreement through completion as of September 30, 2025 were similar compared to the estimates as of December 31, 2024.

Previous wording

Product revenue decreased by $107,000, or approximately 35%, to $198,000 in the six months ended June 30, 2026 from $305,000 for the six months ended June 30, 2025.

Current wording

Product revenue decreased by $156,000, or approximately 35%, to $289,000 in the nine months ended September 30, 2026 from $445,000 for the nine months ended September 30, 2025.

Previous wording

Cost of product revenue decreased by $33,000, or approximately 37%, to $57,000 in the six months ended June 30, 2026 from $90,000 for the six months ended June 30, 2025. The decrease was primarily due to lower sales volume of FreeHold Duo and Trio intracorporeal organ retractors.

Current wording

Cost of product revenue decreased by $54,000, or approximately 39%, to $85,000 in the nine months ended September 30, 2026 from $139,000 for the nine months ended September 30, 2025. The decrease was primarily due to lower sales volume of FreeHold Duo and Trio intracorporeal organ retractors.

Previous wording

The following table summarizes our research and development expenses for the six months ended June 30, 2026 and 2025 (in thousands):

Current wording

The following table summarizes our research and development expenses for the nine months ended September 30, 2026 and 2025 (in thousands):

Previous wording

Research and development expenses increased by $5.0 million, or approximately 18%, to $32.4 million for the six months ended June 30, 2026 from $27.3 million for the six months ended June 30, 2025. This is primarily due to an increase in support of ongoing work to advance the BACKBEAT Trial and the Virtue Trial. The increase included an increase in personnel-related expenses of $3.9 million due to increased headcount and consulting costs, an increase of $3.0 million in clinical development costs, partially offset by a decrease of $1.6 million in non-clinical development costs associated with research and development program costs, supplies, and testing.

Current wording

Research and development expenses increased by $8.7 million, or approximately 21%, to $50.1 million for the nine months ended September 30, 2026 from $41.4 million for the nine months ended September 30, 2025. This is primarily due to an increase in support of ongoing work to advance the BACKBEAT Trial and the Virtue Trial. The increase included an increase in personnel-related expenses of $6.2 million due to increased headcount and consulting costs, an increase of $4.9 million in clinical development costs, partially offset by a decrease of $1.9 million in non-clinical development costs associated with research and development program costs, supplies, and testing and a decrease of stock based compensation of $353,000.

Previous wording

The total research and development expenses summarized above include $6.8 million for the six months ended June 30, 2025 related to the Terumo Agreement, which was terminated in October 2025.

Current wording

The total research and development expenses summarized above include $10.0 million for the nine months ended September 30, 2025 related to the Terumo Agreement, which was terminated in October 2025.

Previous wording

Selling, general and administrative expenses decreased by $325,000, or approximately 3%, to $12.2 million for the six months ended June 30, 2026, from $12.5 million of expense for the six months ended June 30, 2025. The decrease primarily resulted from a decrease of $642,000 in stock-based compensation, partially offset by an increase of $288,000 in accounting, finance, and legal expenses.

Current wording

Selling, general and administrative expenses decreased by $1.8 million, or approximately 9%, to $17.8 million for the nine months ended September 30, 2026 from $19.6 million for the nine months ended September 30, 2025. The decrease primarily resulted from a decrease of $1.2 million in stock-based compensation and a decrease of $1.2 million in legal and professional fees partially offset by an increase in investor relations expense of $544,000.

Previous wording

Interest (expense) income, net decreased by $2.7 million, or approximately 2092%, to $2.6 million of interest expense for the six months ended June 30, 2026, from $130,000 of income for the six months ended June 30, 2025. The net interest expense in the 2026 period consisted primarily of monthly interest expense resulting from the 2024 LSA, the Medtronic Note, and the Royalty Purchase Agreement partially offset by interest earned from marketable securities. The net interest income in the 2025 period consisted primarily of interest earned from marketable securities partially offset by monthly interest expense resulting from the 2024 LSA.

Current wording

Interest expense, net increased by $4.7 million, or approximately 1212%, to $5.1 million of interest expense for the nine months ended September 30, 2026, from $385,000 of interest expense for the nine months ended September 30, 2025. The net interest expense in the 2026 period consisted primarily of monthly interest expense resulting from the 2024 LSA, the Medtronic Note, and the Royalty Purchase Agreement partially offset by interest earned from marketable securities. The net interest expense in the 2025 period consisted primarily of monthly interest expense resulting from the 2024 LSA and Royalty Purchase Agreement, partially offset by interest earned from marketable securities.

Previous wording

The derivative liability of the Series A Preferred Stock was remeasured to a fair value of $2.5 million as of June 30, 2026. We recognized a loss of $324,000 for the three months ended June 30, 2026 primarily due to changes in the fair value inputs and assumptions used in the valuation model since the measurement at March 31, 2026.

Current wording

The derivative liability of the Series A Preferred Stock was remeasured to a fair value of $1.6 million as of September 30, 2026. We recognized a gain of $1.2 million for the nine months ended September 30, 2026 primarily due to changes in the fair value inputs and assumptions used in the valuation model since the measurement at December 31, 2025.

Previous wording

Partnership revenue decreased by $667,000, or 100%, in the three months ended June 30, 2026 from $667,000 for the three months ended June 30, 2025. Partnership revenue related to the recognition of the combined performance obligation for the license granted to Terumo and the ongoing research and development services over the estimated performance period for the Virtue SAB coronary ISR indication, using a proportional performance model, based on the costs incurred relative to the total estimated costs of the research and development services. Prior to the termination of the Terumo Agreement, as of each quarterly reporting date, we evaluated our estimates of the total costs expected to be incurred through the completion of the combined performance obligation and updated our estimates as necessary. On October 24, 2025, we entered the Termination and ROFR Agreement, which superseded and terminated the Terumo Agreement, and we no longer have any performance obligations under the Terumo Agreement.

Current wording

Partnership revenue decreased by $721,000, or 100%, in the three months ended September 30, 2026 from $721,000 for the three months ended September 30, 2025. Partnership revenue related to the recognition of the combined performance obligation for the license granted to Terumo and the ongoing research and development services over the estimated performance period for the Virtue SAB coronary ISR indication, using a proportional performance model, based on the costs incurred relative to the total estimated costs of the research and development services. Prior to the termination of the Terumo Agreement, as of each quarterly reporting date, we evaluated our estimates of the total costs expected to be incurred through the completion of the combined performance obligation and updated our estimates as necessary. On October 24, 2025, we entered the Termination and ROFR Agreement, which superseded and terminated the Terumo Agreement, and we no longer have any performance obligations under the Terumo Agreement.

Previous wording

For the three months ended June 30, 2025, the expenses incurred related to the Terumo Agreement were $3.3 million. The estimated total costs associated with the Terumo Agreement through completion as of June 30, 2025 were similar compared to the estimates as of March 31, 2025.

Current wording

For the three months ended September 30, 2025, the expenses incurred related to the Terumo Agreement were $3.3 million. The estimated total costs associated with the Terumo Agreement through completion decreased by approximately 0.3% as of September 30, 2025 as compared to the estimates as of June 30, 2025.

Previous wording

Cost of product revenue decreased by $21,000, or approximately 46%, to $25,000 in the three months ended June 30, 2026 from $46,000 for the three months ended June 30, 2025. The decrease was primarily due to lower sales volume of FreeHold Duo and Trio intracorporeal organ retractors.

Current wording

Cost of product revenue decreased by $21,000, or approximately 43%, to $28,000 in the three months ended September 30, 2026 from $49,000 for the three months ended September 30, 2025. The decrease was primarily due to lower sales volume of FreeHold Duo and Trio intracorporeal organ retractors.

Previous wording

Research and development expenses increased by $2.7 million, or approximately 20%, to $16.6 million for the three months ended June 30, 2026, from $13.9 million for the three months ended June 30, 2025. This is primarily due to an increase in support of ongoing work to advance the BACKBEAT Trial and the Virtue Trial. The increase included an increase of $2.3 million in clinical development costs and an increase in personnel-related expenses of $1.8 million due to increased headcount and consulting costs, partially offset by a decrease of $1.2 million in non-clinical development costs associated with research and development program costs, supplies, and testing. ​

Current wording

Research and development expenses increased by $3.7 million, or approximately 26%, to $17.7 million for the three months ended September 30, 2026, from $14.0 million for the three months ended September 30, 2025. This is primarily due to an increase in support of ongoing work to advance the BACKBEAT Trial and the Virtue Trial. The increase included an increase in personnel-related expenses of $2.2 million due to increased headcount and consulting costs and an increase of $1.9 million in clinical development costs and, partially offset by a decrease of $321,000 in non-clinical development costs associated with research and development program costs, supplies, and testing.

Previous wording

The total research and development expenses summarized above include $3.3 million for the three months ended June 30, 2025 related to the Terumo Agreement, which was terminated in October 2025.

Current wording

The total research and development expenses summarized above include $3.2 million for the three months ended September 30, 2025 related to the Terumo Agreement, which was terminated in October 2025.

Previous wording

Selling, general and administrative expenses decreased by $435,000, or approximately 7%, to $5.8 million for the three months ended June 30, 2026, from $6.3 million of expense for the three months ended June 30, 2025. The decrease primarily resulted from a decrease of $557,000 in stock-based compensation, partially offset by an increase of $120,000 in accounting, finance, and legal expenses.

Current wording

Selling, general and administrative expenses decreased by $1.5 million, or approximately 21%, to $5.6 million for the three months ended September 30, 2026, from $7.1 million of expense for the three months ended September 30, 2025. The decrease primarily resulted from a decrease of $1.5 million in legal and professional fees.

Previous wording

Interest expense, net increased by $1.7 million, or approximately 4811%, to $1.8 million of net interest expense for the three months ended June 30, 2026, from $36,000 of net interest expense for the three months ended June 30, 2025. The net interest expense in the 2026 period consisted primarily of monthly interest expense resulting from the 2024 LSA, the Medtronic Note and the Royalty Purchase Agreement partially offset by interest earned from marketable securities. The net interest expense in the 2025 period consisted primarily of monthly interest expense resulting from the 2024 LSA partially offset by interest earned from marketable securities.

Current wording

Interest expense, net increased by $1.9 million, or approximately 378%, to $2.5 million of net interest expense for the three months ended September 30, 2026, from $515,000 of net interest expense for the three months ended September 30, 2025. The net interest expense in the 2026 period consisted primarily of monthly interest expense resulting from the 2024 LSA, the Medtronic Note and the Royalty Purchase Agreement partially offset by interest earned from marketable securities. The net interest expense in the 2025 period consisted primarily of monthly interest expense resulting from the 2024 LSA partially offset by interest earned from marketable securities.

Previous wording

The derivative liability of the Series A Preferred Stock was remeasured to a fair value of $2.5 million as of June 30, 2026. We recognized a gain of $289,000 for the six months ended June 30, 2026 primarily due to changes in the fair value inputs and assumptions used in the valuation model since the measurement at December 31, 2025.

Current wording

The derivative liability of the Series A Preferred Stock was remeasured to a fair value of $1.6 million as of September 30, 2026. We recognized a gain of $867,000 for the three months ended September 30, 2026 primarily due to changes in the fair value inputs and assumptions used in the valuation model since the measurement at June 30, 2026.

Previous wording

From inception through June 30, 2026, we have incurred significant operating losses and negative cash flows from our operations. Our net losses were $44.4 million and $38.1 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $407.0 million. We have funded our operations primarily through the issuance of our common stock, convertible preferred stock, and warrants, as well as proceeds from the Business Combination, the prior Terumo Agreement and the Termination and ROFR Agreement, borrowings under debt arrangements, the sale of future revenues, the sale of strategic investments, and, to a lesser extent, revenue from FreeHold products. On January 9, 2026, Haemonetics closed on an acquisition of Vivasure pursuant to which we are eligible to receive up to $10.7 million of proceeds in 2026 made up of approximately $4.8 million already received and approximately $5.9 million in a first milestone payment expected later this year. We had $110.0 million in cash and cash equivalents and marketable securities at June 30, 2026, comprised of $20.5 million in cash and cash equivalents and $89.5 million in marketable securities. Cash and cash equivalents consisted primarily of bank deposits and money market funds while short-term marketable securities consisted primarily of our investments in corporate and government debt securities.

Current wording

From inception through September 30, 2026, we have incurred significant operating losses and negative cash flows from our operations. Our net losses were $63.2 million and $58.9 million for the nine months ended September 30, 2026 and 2025, respectively. As of September 30, 2026, we had an accumulated deficit of $425.8 million. We have funded our operations primarily through the issuance of our common stock, convertible preferred stock, and warrants, as well as proceeds from the Business Combination, the prior Terumo Agreement and the Termination and ROFR Agreement, borrowings under debt arrangements, the sale of future revenues, the sale of strategic investments, and, to a lesser extent, revenue from FreeHold products. We had $101.9 million in cash and cash equivalents and marketable securities at September 30, 2026, comprised of $27.8 million in cash and cash equivalents and $74.1 million in marketable securities. Cash and cash equivalents consisted primarily of bank deposits and money market funds while short-term marketable securities consisted primarily of our investments in corporate and government debt securities.

Previous wording

We intend to prioritize spending on our two flagship product candidates and expect operating expenses to increase accordingly as we focus on continued execution of the BACKBEAT Trial for AVIM Therapy and Virtue Trial for Virtue SAB. Expenses will primarily support clinical study costs as well as other research and development activities.

Current wording

We intend to prioritize spending on our two flagship product candidates as we focus on continued execution of the BACKBEAT Trial for AVIM Therapy and the Virtue Trial for Virtue SAB. Expenses will primarily support clinical study costs as well as other research and development activities.

Previous wording

Based on internally prepared budget estimates that reflect our operating priorities, we anticipate that our cash and cash equivalents, and marketable securities are sufficient to fund our operations into the fourth quarter of 2027. The amount and timing of our future funding requirements may change from this current estimate and are dependent on many factors, including the cost and pace of execution of clinical studies and research and development activities, the strength of results from clinical studies and other research, development and manufacturing efforts. There are no assurances that any of these factors will be favorable to us, and we may need to seek additional sources of liquidity to meet our funding requirements earlier than current estimates, including the issuance of new equity, and/or other financing structures. In this regard, as of the date of this Quarterly Report on Form 10-Q, we may sell up to $92.4 million of shares of our common stock under the sales agreement (the “Sales Agreement”) we entered into with TD Securities (USA) LLC (“TD Cowen”) pursuant to which we may offer and sell, from time to time through TD Cowen, shares of our common stock by any method permitted by law and deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act.

Current wording

Based on internally prepared budget estimates that reflect our operating priorities, we anticipate that our cash and cash equivalents, and marketable securities are sufficient to fund our operations through 2028. The amount and timing of our future funding requirements may change from this current estimate and are dependent on many factors, including the cost and pace of execution of clinical studies and research and development activities, the strength of results from clinical studies and other research, development and manufacturing efforts, and any future impact of Qualified Cash commitments under the 2024 LSA. There are no assurances that any of these factors will be favorable to us, and we may need to seek additional sources of liquidity to meet our funding requirements earlier than current estimates, including the issuance of new equity, and/or other financing structures. In this regard, as of the date of this Quarterly Report, we may sell up to $86.2 million of shares of our common stock under the sales agreement (the “Sales Agreement”) we entered into with TD Securities (USA) LLC (“TD Cowen”) pursuant to which we may offer and sell, from time to time through TD Cowen, shares of our common stock by any method permitted by law and deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the “Securities Act”).

Previous wording

Net cash used in operating activities for the six months ended June 30, 2026 was $41.5 million and primarily consisted of our net loss of $44.4 million and changes in net operating assets and liabilities of $3.6 million, partially offset by non-cash charges of $6.5 million. Our non-cash charges primarily consisted of stock-based compensation of $5.4 million, non-cash interest expense on liability related to the Royalty Purchase Agreement of $3.1 million and accrued interest expense on liability related to the note payable of $442,000, partially offset by the gain on the sale of strategic investments of $2.3 million. The net change in operating assets and liabilities was primarily due to a decrease in accounts payable, accrued expenses and other liabilities of $3.3 million and operating lease liabilities of $359,000.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2026 was $61.0 million and primarily consisted of our net loss of $63.2 million and changes in net operating assets and liabilities of $2.9 million, partially offset by non-cash charges of $5.1 million. Our non-cash charges primarily consisted of stock-based compensation of $7.6 million, non-cash interest expense on liability related to the Royalty Purchase Agreement of $5.3 million and accrued interest expense on liability related to the note payable of $1.2 million, partially offset by the gain on the sale of strategic investments of $8.4 million. The net change in operating assets and liabilities was primarily due to a decrease in accounts payable, accrued expenses and other liabilities of $2.5 million and operating lease liabilities of $552,000.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2025 was $32.1 million and primarily consisted of our net loss of $38.1 million and changes in net operating assets and liabilities of $632,000, partially offset by non-cash charges of $6.6 million. Our non-cash charges primarily consisted of stock-based compensation of $6.2 million, partially offset by $161,000 related to accretion and interest of marketable securities. The net change in operating assets and liabilities was primarily due to a decrease in deferred revenue of $1.4 million offset by a decrease in accounts payable, accrued expenses and other liabilities of $888,000.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2025 was $46.7 million and primarily consisted of our net loss of $58.9 million, partially offset by non-cash charges of $10.3 million and changes in net operating assets and liabilities of $1.9 million. Our non-cash charges primarily consisted of stock-based compensation of $9.2 million, partially offset by $491,000 related to accretion and interest of marketable securities. The net change in operating assets and liabilities was primarily due to an increase in accounts payable, accrued expenses and other liabilities of $4.3 million, partially offset by a decrease in deferred revenue of $2.1 million.

Previous wording

Net cash provided by investing activities for the six months ended June 30, 2025 was $29.4 million, which primarily consisted of the sale of $32.4 million of marketable securities, partially offset by the purchase of $2.9 million of marketable securities.

Current wording

Net cash provided by investing activities for the nine months ended September 30, 2026 was $8.0 million, which primarily consisted of the sales of $60.5 million of marketable securities and the sale of strategic investments of $10.9 million, partially offset by the purchases of $62.6 million of marketable securities and purchases of property and equipment of $836,000.

Previous wording

Net cash used in investing activities for the six months ended June 30, 2026 was $13.0 million, which primarily consisted of the purchase of $56.1 million of marketable securities partially offset by the sale of $38.8 million of marketable securities and the sale of strategic investments of $4.8 million.

Current wording

Net cash used in investing activities for the nine months ended September 30, 2025 was $9.2 million, which primarily consisted of the purchase of $50.7 million of marketable securities and purchases of property and equipment of $456,000, partially offset by the sale of $41.9 million of marketable securities.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2026 was $40.3 million, which primarily consisted of $20.0 million of proceeds from the Medtronic Term Loan, $15.0 million of proceeds from the royalty purchase agreement and $5.9 million of proceeds from the sale of our common stock pursuant to the Sales Agreement, partially offset by $616,000 used to settle taxes associated with restricted stock vesting.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2026 was $46.1 million, which primarily consisted of $20.0 million of proceeds from the Medtronic Loan, $15.0 million of proceeds from the royalty purchase agreement and $11.9 million of proceeds from the sale of our common stock pursuant to the Sales Agreement, partially offset by $778,000 used to settle taxes associated with restricted stock vesting.

Previous wording

Our critical accounting policies are described in the MD&A section of our Form 10-K for the year ended December 31, 2025 filed with the SEC on March 12, 2026. There have been no material changes to our critical accounting policies during the six months ended June 30, 2026*.*

Current wording

Our critical accounting policies are described in the MD&A section of our Form 10-K for the year ended December 31, 2025 filed with the SEC on March 12, 2026. There have been no material changes to our critical accounting policies during the nine months ended September 30, 2026*.*

Previous wording

We are a “smaller reporting company” as defined in Rule 12b-2 promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). As a smaller reporting company, we will continue to not be required to comply with the auditor attestation requirements of Section 404(a) of the Sarbanes-Oxley Act of 2002 as long as (a) our annual revenue is less than $100.0 million during the most recently completed fiscal year and (b) the market value of our voting and non-voting common stock held by non-affiliates is less than $700.0 million as of the last business day of the second quarter of such fiscal year. We may also take advantage of certain reduced disclosure requirements as a smaller reporting company, including, but not limited to, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements. We will be able to take advantage of these scaled disclosures for so long as (i) the market value of our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or (ii)(a) our annual revenue is less than $100.0 million during the most recently completed fiscal year and (b) the market value of our voting and non-voting common stock held by non-affiliates is less than $700.0 million as of the last business day of the second quarter of such fiscal year.

Current wording

requirements as a smaller reporting company, including, but not limited to, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements. We will be able to take advantage of these scaled disclosures for so long as (i) the market value of our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or (ii)(a) our annual revenue is less than $100.0 million during the most recently completed fiscal year and (b) the market value of our voting and non-voting common stock held by non-affiliates is less than $700.0 million as of the last business day of the second quarter of such fiscal year.