OBIO 10-K & 10-Q changes, risk factors and insider trading

We have a history of net losses, and we expect to continue to incur losses for the foreseeable future. If we ever achieve profitability, we may not be able to sustain itit.

We have incurred losses since our inception and expect to continue to incur losses for the foreseeable future. We have reported a net loss of approximately$52.7 million for the year ended December 31, 2025 and a net loss of $61.0 million for the year ended December 31, 2024 and a net loss of approximately $49.1 million for the year ended December 31, 2023.2024. As a result of these losses, as of December 31, 2024,2025, we had an accumulated deficit of approximately $309.9$362.6 million. We expect to continue to incur net losses for the foreseeable future.

We expect our expenses may increase substantially in connection with our ongoing and planned activities, particularly as we conduct our ongoing BACKBEAT study and our planned Virtue ISR-US pivotal study.Trial. Furthermore, we have incurred and will continue to incur additional costs associated with operating as a public company. Accordingly, we may need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital or obtain adequate funds when needed or on acceptable terms, we may be required to delay, limit, reduce or terminate our research and development programs or any future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. In addition, attempting to secure additional financing may divert the time and attention of our management from day-to-day activities and distract from our research and development efforts.

The amount and timing of our future funding requirements 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, as well as the potential receipt of revenues or other payments or investments under a restructured Terumo Agreement, the Medtronic Agreement and/or future collaborations, and the realization of cash from the acquisition of Vivasure by Haemonetics.

We currently have a limited operating history and limited sources of revenue and may never become profitableprofitable.

If we do not achieve our projected development and commercialization goals, our business may be harmedharmed.

For planning purposes, we estimate the timing of the accomplishment of various scientific, clinical, regulatory and other product development and commercialization goals, which we sometimes refer to as milestones. These milestones include the commencement or completion of scientific studies and clinical studies and the submission of regulatory applications. We base these milestones on a variety of assumptions, which are subject to numerous risks and uncertainties. Further, our collaboration agreement with Terumo, as further described herein, includes payments tied to the achievement of certain milestones, which in some cases, must be achieved by a specified calendar date. OtherOur future collaboration agreements may have similar provisions. There is a risk we will not achieve these milestones on a timely basis or at all. Even if we achieve these milestones, the actual timing of the achievement of these milestones can vary dramatically compared to our estimates, often for reasons beyond our control, depending on numerous factors, including:

If we do not meet these milestones for our products or if we are delayed in achieving these milestones, the development and commercialization of new product candidates, modifications of existing products or sales of existing products for new indications may be prevented or delayed, which could damage our reputation or materially adversely affect our business. Further, we may not receive milestone-based payments from partners on a timely basis or at all, which may have an adverse impact on our anticipated financial resources. In addition, Terumo has the right to terminate, and other partners may have the right to terminate or renegotiate, agreements if certain milestones are not achieved at all or on a timely basis. Even if we achieve a milestone for a product or product candidate, market acceptance for the product or product candidate is not assured. See “— Risks Related to Our Reliance on Third Parties — We and Terumo have yet been unable to come to agreement with respect to amending the Terumo Agreement. While we and Terumo are pursuing mediation, we cannot provide assurance that such efforts will be successful or that we or Terumo will not seek to terminate the Terumo Agreement.”

The clinical study process required to obtain regulatory approvals or certifications carries substantial risks and is lengthy and expensive with uncertain outcomes. If our clinical studies are unsuccessful or significantly delayed, or if we do not complete our clinical studies, our business may be harmedharmed.

In order to obtain approval of a PMA from the FDA for a device-led combination product candidate, such as our Virtue SAB, or for device candidates like AVIM therapyTherapy or CNT-HF which are designed to be integrated with the collaboration of device manufacturers into their existing medical devices such as pacemakers, as well as other future product candidates, or marketing approval for an NDA, such as our extended release formulation of sirolimus called “SirolimusEFR,” we must conduct well-controlled clinical studies designed to assess the safety and efficacy of the product candidate, in addition to nonclinical and other product development studies. Clinical development is a long, expensive and uncertain process and is subject to delays and to the risk that products may not ultimately adequately demonstrate safety or effectiveness in treating the indications for which they are designed. Completion of the clinical studies required to support a marketing authorization usually takes several years or more. We cannot assure you that we will successfully complete clinical testing of our products within the periods we have planned, or at all. Even if we achieve positive interim or preliminary results in clinical studies, these results do not necessarily predict final results, and positive results in early trials do not necessarily indicatepredict success in later trials. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies have suffered significant setbacks in advanced clinical studies, even after receiving positive results in earlier trials. Any of our products may malfunction or may produce undesirable adverse effects that could cause us, IRBs or regulatory authorities to interrupt, delay or halt clinical studies. We, the FDA, or another regulatory authority may suspend or terminate clinical studies at any time to avoid exposing trial participants to unacceptable health risks.

We could also encounter delays if a clinical study is suspended or terminated by us, by the IRBs of the institutions at which such studies are being conducted, by the Data Safety Monitoring Board for such trial or by the FDA or other regulatory authorities. Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical study in accordance with regulatory requirements or our clinical protocols, results of regulatory inspection of the clinical study operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using the investigational product, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical study. If we experience delays in the completion of, or termination of, any clinical study, the approval, certification and commercial prospects of our deviceproduct candidate will be harmed, and our ability to generate product revenues from any of these product candidates will be delayed. In addition, any delays in completing our clinical studies will increase our costs, slow down the approval or certification process and jeopardize our ability to commence product sales and generate revenues. Any of these occurrences may harm our business, financial condition and prospects significantly. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical studies may also ultimately lead to the denial of regulatory approval of our product candidates.

Failures or perceived failures in our clinical studies will delay and may prevent our product candidate development and regulatory approval or certification process, damage our business prospects and negatively affect our reputation and competitive positionposition.

Clinical studies must be conducted in accordance with the laws and regulations of the FDA and other applicable regulatory authorities’ legal requirements, regulations or guidelines, and are subject to oversight by these governmental agencies and IRBs at the medical institutions where the clinical studies are conducted. In addition, clinical studies must be conducted under GCPs with supplies of our product candidates produced under cGMP and/or FDA’s QSRQMSR and other requirements. Furthermore, we rely on CROs, consultants and clinical study sites to ensure the proper and timely conduct of our clinical studies and while we have agreements governing their committed activities, we have limited influence over their actual performance. We depend on our collaborators and on medical institutions and CROs to conduct our clinical studies in compliance with GCP requirements. To the extent our collaborators or the CROs fail to enroll participants for our clinical studies, fail to conduct the study to GCP standards or are delayed for a significant time in the execution of trials, including achieving full enrollment, we may be affected by increased costs, program delays or both. In addition, clinical studies that are conducted in countries outside the United States may subject us to further delays and expenses as a result of increased shipment costs, additional regulatory requirements and the engagement of non-U.S. CROs, as well as expose us to risks associated with clinical investigators who are unknown to the FDA, and different standards of diagnosis, screening and medical care, and sufficient heterogeneity in clinical patient populations to support approval.

Even if we obtain all necessary FDA approvals, our product candidates may not achieve or maintain market acceptance and may be subject to additional regulatory requirements post-approvalpost-approval.

We may be unable to compete successfully with larger companies in our highly competitive industryindustry.

The medical technology and pharmaceutical industries are highly competitivecompetitive, and the medical device industry is characterized by rapid and significant change. Many of our current and potential competitors have substantially greater financial, manufacturing, marketing, and technical resources than we do. Larger competitors may have substantially larger sales and marketing operations than we or our partners have or plan to have and may have greater name recognition. This may allow those competitors to spend more time with potential customers and to focus on a larger number of potential customers, which would give them a significant advantage over the sales and marketing team we would use and our international distributors in making sales.

Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provideprovide.

The sizes of the markets for product candidates have not been established with precision,precision and may be smaller than we estimateestimate.

The long-term macroeconomic effects of the COVID-19 pandemic and any future pandemic or epidemic could adversely impact our business, including our clinical studies and financial conditioncondition.

Interim, “top-linetopline” and preliminary data from our clinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final datadata.

From time to time, we may publicly disclose preliminary or top-line data from our preclinical studies and clinical studies, which is based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial. We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the top-line or preliminary results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Top-lineTopline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, top-line data should be viewed with caution until the final data are available.

Our product candidates have in the past and may in the future be associated with serious adverse events, undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval or certification, limit their commercial potential or result in significant negative consequencesconsequences.

We depend on attracting, retaining and developing key management, clinical, scientific, regulatory, quality, marketing and other expert personnel, and losing these personnel could impair the development and sales of our products or product candidatescandidates.

If we make acquisitions, we could incur significant costs and encounter difficulties that harm our businessbusiness.

If we do not manage our growth or control costs related to growth, our results of operations will suffersuffer.

Litigation and other legal proceedings may adversely affect our businessbusiness.

Product liability and other claims against us may reduce demand for our products or result in substantial damagesdamages.

Our business exposes us to potential liability for risks that may arise from the clinical testing of our product candidates, the use of our products by physicians, and the manufacture and sale of any approved products. Individuals may bring a product liability claims against us, including frivolous lawsuits, if one or more of our products causes, or merely appears to have caused, an injury.

The misuse or promotion of off-label uses of our products may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory bodies, any of which could be costly to our businessbusiness.

Any products that we market will be approved for specific indicated uses and subject to limitations on those uses as specified in their respective approved foror certified labeling. Uses outside of the approved or certified indications for use are known as “off-label uses.” We cannot prevent a physician from using our products off-label in the physician’s independent professional medical judgment. However, there may be increased risk of injury to patients if physicians attempt to use our products off-label. Furthermore, the use of our products for indications, other than those approved or certified by the FDA or by any foreign regulatory authority or notified body, may not effectively treat such conditions, which could harm our reputation in the marketplace among physicians and patients.

The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products, such as our product candidates, if approved or certified. With only limited exceptions, a product generally may not be promoted for off-label uses. If the FDA or any foreign regulatory body determines that our promotional materialsmaterials, training or trainingother activities constitute promotion of an off-label use, it could request that we modify our trainingmaterials orand promotional materialsactivities or subject us to regulatory or enforcement actions, including the issuance or imposition a regulatory letter (such as of an untitled or warning letter), injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action under other regulatory authority,legislation, such as false claims laws, if they consider our business activities to constitute promotion of an off-label use, which could result in significant penalties, including, but not limited to, criminal, civil and administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs and the curtailment of our operations.

In addition, physicians may misuse our products,products or use improper techniques if they are not adequately trained, potentially leading to injury and an increased risk of product liability. If so, we may become subject to costly litigation by our customers or their patients. Product liability claims could divert management’s attention from our core business, be expensive to defend and result in sizable damage awards against us that may not be covered by insurance.

Our information technology systems, or those of any of our CROs, manufacturers, other contractors, consultants, collaborators or potential future collaborators, may fail or suffer security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data, or personal data, which could result in additional costs, loss of revenue, significant liabilities, harm to our brand and material disruption of our operationsoperations.

We must successfully maintain and upgrade our information technology systems, and our failure to do so could have a material adverse effect on our business, financial condition and results of operationsoperations.

As we expand, in order to remain competitive, we will need to significantly expand and improve our information technology systems and personnel to support historical and expected future growth. As such, we will continue to invest in and implement,implement significant modifications and upgrades to our information technology systems and procedures, including replacing legacy systems with successor systems, making changes to legacy systems or acquiring new systems with new functionality, hiring employees with information technology expertise and building new policies, procedures, training programs and monitoring tools. These types of activities subject us to inherent costs and risks associated with replacing and changing these systems, fulfillincluding customerrisks orders,and costs relating to, among other things, potential disruption of our business and internal control structure, substantial capital expenditures, additional administration and operating expenses, acquisition and retention of sufficiently skilled personnel to implement and operate the new systems, demands on management time and other risks and costs of delays or difficulties in transitioning to or integrating new systems into our current systems. These implementations, modifications and upgrades may not result in productivity improvements at a level that outweighs the costs of implementation, or at all. In addition, difficulties with implementing new technology systems, delays in our timeline for planned improvements, significant system failures, or our inability to successfully modify our information systems to respond to changes in our business needs may cause disruptions in our business operations and have a material adverse effect on our business, financial condition and results of operations.

Economic conditions may adversely affect our business, financial condition and share priceprice.

TheIn recent years, the global credit and financial markets have recently experienced extreme volatility and disruptions, including severely diminished liquidity and credit availability, declines in consumer confidence, inflation, declines in economic growth, wage inflation because of labor shortages and uncertainty about economic stability. The financial markets and the global economy may also be adversely affected by the current or anticipated impact of military conflict, including the conflict between Russia and Ukraine and the Israeli-Palestinianconflict conflict,between the United States, Israel and Iran, terrorism or other geopolitical events. Sanctions imposed by the United States and other countries in response to such conflicts, including the one in Ukraine, may also adversely impact the financial markets and the global economy, and any economic countermeasures by affected countries and others could exacerbate market and economic instability. In addition, the attacksmilitary byconflict Hamasbetween onthe United States, Israel inand October 2023, Israel’s responseIran and escalation risks of a potential broader armedwidening conflict in the Middle East are likely to continue impactingto impact the global economy, includingand thatany ofprolonged theor Unitedexpanded Statesconflict and have added to concerns of a widening conflictinstability in the Middle East.East Incould particular,further oildisrupt pricesglobal havetrade, becomeenergy increasinglysupplies volatileand inmarket the aftermath of the attacks on Israel.confidence. Each of the developments described above, or any combination of them, could adversely affect our businesses, financial condition and results of operations. There can be no assurance that further deterioration in credit and financial markets and confidence in economic conditions will not occur. Our general business strategy may be adversely affected by any such economic downturn, volatile business environment or continued unpredictable and unstable market conditions. If the current equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult, more costly and more dilutive. These developments, or the perception that any of them could occur, may restrict the ability of key market participants to operate in certain financial markets or restrict our access to capital. For example, there is a risk that one or more of our current service providers, manufacturers and other partners may not survive an economic downturn, which could directly affect our ability to attain our operating goals on schedule and on budget. Any of these factors could have a material adverse effect on our business, financial condition and results of operations and reduce the price of our common stock.

Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expensesexpenses.

Disruptions at the FDA, other government agencies and notified bodies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved, certified or commercialized in a timely manner or at all, or otherwise prevent those agencies and bodies from performing normal business functions on which the operation of our business may rely, which could negatively impact our businessbusiness.

The ability of the FDA, other government agencies and notified bodies to review and approve or certify new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory and policy changes, the FDA’s or other government agencies’ ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s, other government agencies’ and notified bodies’ ability to perform routine functions. These factors may also impact the FDA’s ability to provide feedback on clinical trials and development programs, to meet with sponsors and to otherwise review regulatory submissions. Average review times at the FDA, other government agencies and notified bodies have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA, other agencies and notified bodies may also slow the time necessary for new drugs and medical devices or modifications to approved drugs or approved or certified medical devices to be reviewed and/or approved or certified by necessary government agencies or notified bodies, which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. ForIn example,addition, the newcurrent U.S. presidential administration recentlyhas announced planssought to reduce the number of federal employees by establishing voluntary termination programs, by position eliminations or by involuntary terminations.employees. If funding for the FDA is reduced, if the FDA workforce is reduced, if FDA priorities are changed or if a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions.

In addition, in the EU, notified bodies must be officially designated to certify products and services in accordance with the EU Medical Devices Regulation. While several notified bodies have been designated, currentcurrently designated notified bodies are facing a large amount of requests with the new regulation as a consequence of which review times have lengthened. This situation may impact the ability of our notified body(ies) to timely review and process our regulatory submissions, and our ability to grow our business in the EEA.

We, in conjunction with our partners, intend to expand sales ofsell our products internationally in the future, but we and our partners may experience difficulties in obtaining regulatory approval or certification or in successfully marketing and distributing our products internationally even if approved or certified. A variety of risks associated with marketing and distributing our products internationally could materially adversely affect our businessbusiness.

Our future growth may depend, in part, on our and our partners’ ability to develop and commercialize our planned and future products in foreign markets. Sales of our products outside of the United States are and will be subject to foreign regulatory requirements governing clinical studies and marketing approval or certification, as well as FDA regulation of the export of drugs and medical devices from the United States. To obtain separate regulatory approval or certification in many other countries we must comply with numerous and varying regulatory requirements regarding safety and efficacy and governing, among other things, clinical studies, commercial sales, pricing and distribution of our planned or future products. We and/or our partners will incur substantial expenses in connection with our expected international expansion. Additional risks related to operating in foreign countries include:

We may in the future bring certain cGMP product release testing, stability testing and cGMP pharmaceutical manufacturing capabilities in-house, and we may not be able to do so successfully or in compliance with FDA regulationsregulations.

We have brought certain activities that we previously outsourced to third parties, in-house, and we may bring certain additional activities in-house in the future. For example, we have brought certain cGMP product release testing related to SirolimusEFR in-house. In addition, we may eventually bring the manufacture of pharmaceutical drug products, such as SirolimusEFR, in-house. To the extent we do bring these functions in-house, we will be directly subject to FDA and other regulations with respect to these activities, such as the FDA’s good laboratory practice requirements, cGMP requirements and similar foreign requirements. We cannot provide assurance that we will be able to perform these functions effectively or comply with applicable regulations if we bring these functions in-house.

We may expend our limited resources to pursue a particular product or indication and fail to capitalize on products or indications that may be more profitable or for which there is a greater likelihood of successsuccess.

Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limitedlimited.

Changes in tax laws could adversely affect the taxes we pay and, as a result, adversely affect our financial condition and results of operationsoperations.

We are, and expect to continue to be, highly dependent on partners to drive the successful marketing and sale of our initial product candidates. There is no assurance that we will be able to form and properly manage partnerships. There is no assurance that partnerships will be successfulsuccessful.

We intend to primarily pursue licensing and distribution arrangements with strategic partners to commercialize and sell our product candidates. As such, licensing and collaboration payments, including upfront and milestone payments, as well as royalties and revenue sharing arrangements related to our products and product candidates, will account for substantially all of our revenue for the foreseeable future. Any of these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures, issue securities that dilute our existing stockholders or disrupt our management and business. In addition, we face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex. We have limited experience in negotiating, establishing and managing such collaborations and we may be unable to successfully form and maintain such arrangements. WithoutFor commercializationexample, partners,in 2025, we mayand notTerumo haveentered adequateinto financialthe orTermination otherand resourcesROFR Agreement, pursuant to successfullywhich commercializewe ourand productTerumo candidates.terminated Inthe addition,Terumo any potential future collaborations may be terminable by our strategic partners,Agreement, and we may not be able to adequatelyfind protecta new strategic partner for our rightsVirtue underSAB theseproduct agreements.candidate. Furthermore,See strategic“Our partnersCompany—Our mayFlagship negotiateCandidates—Virtue forSAB” exclusivein rightsItem to(Business) commercialize our products or certain rights to control decisions regardingof the developmentAnnual and commercialization of our products, if approved, and may not conduct those activities in the same manner as we do. Any termination of collaborations we have entered into or may enter into in the future, or any delay in entering into collaborations related to our products or product candidates, could delay the development and commercialization of our products or product candidates and reduce their competitiveness if they reach the market, which could have a material adverse effectReport on ourForm business, financial condition and results of operations.10-K.

Since LegacyOrchestra Orchestra’sBioMed, Inc.’s inception, we have devoted the substantial majority of our resources to performing 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 common stock, convertible preferred stockstock, and warrants, as well as proceeds from the Business Combination, as well as through proceeds from our distribution agreement withprior Terumo (Agreement and the “TerumoTermination Agreement”),and ROFR Agreement, borrowings under debt arrangementsarrangements, the sale of future revenues, and, to a lesser extent, from product revenue from our subsidiary, FreeHold Surgical, LLC. (“FreeHold”). ThroughAs of December 31, 2024,2025, we have raised a cumulative $252.3$356.5 million in gross proceedsproceeds. throughFuture thecommitted issuancecash ofreceipts convertibleexpected preferredin stock,April proceeds2026 frominclude the Business Combination and other equity sales, and have received $30.0$20.0 million from the TerumoMedtronic Loan Agreement (as such term is defined in Note 16 to the Consolidated Financial Statements – “Debt Financing”), and an additional $15.0 million from Ligand pursuant to the Royalty Purchase Agreement. On January 9, 2026, we received $4.7 million pursuant to the sale of our Vivasure investment. We have incurred net losses each year since inception. Our net losses were $61.0$52.7 million and $49.1$61.0 million for the years ended December 31, 20242025 and 2023,2024, respectively. We expect to continue to incur significant losses for the foreseeable future. As of December 31, 2024,2025, we had an accumulated deficit of $309.9$362.6 million.

LegacyOrchestra Orchestra,BioMed, Inc., our wholly owned subsidiary, was incorporated in Delaware in 2017 and completed a recapitalization and mergers with Caliber Therapeutics, Inc., a Delaware corporation that has, among other things, the rights to the Virtue SAB product candidate and BackBeat Medical, Inc., a Delaware Corporation that has, among other things, the rights to the AVIM therapyTherapy product candidate, in 2018. LegacyOrchestra OrchestraBioMed, Inc. completed the conversions of Caliber Therapeutics, Inc. to Caliber Therapeutics, LLC, a Delaware limited liability company, and BackBeat Medical, Inc. to BackBeat Medical, LLC, a Delaware limited liability company, in 2019.

To date, our partnership revenues have related to the Terumo Agreement described below. In future periods, partnership revenues may also include revenues related to the Exclusive License and Collaboration Agreement, dated as of September 30, 2022, by and among, LegacyOrchestra Orchestra,BioMed, Inc., BackBeat Medical, LLC and Medtronic, Inc. (an affiliate of Medtronic plc) (the “Medtronic Agreement”), discussed in Note 54 to the Consolidated Financial Statements.

LegacyOrchestra OrchestraBioMed, Inc. entered into the Terumo Agreement in June 2019 and has determined that the arrangement represents a contract with a customer and is therefore in scope of ASC 606, Revenues from Contracts with Customers (“ASC 606”). Under the Terumo Agreement, LegacyOrchestra OrchestraBioMed, Inc. received an upfront payment of $30.0 million in 2019 and an equity commitment of up to $5$5.0 million of which $2.5 million was invested in June 2019 as part of the LegacyOrchestra OrchestraBioMed, Inc. Series B-1 financing and $2.5 million was invested in June 2022 as part of the LegacyOrchestra OrchestraBioMed, Inc. Series D-2 financing.

We recorded the $30.0 million non-refundable, upfront payment received in 2019 from Terumo within deferred revenue and arewere recognizing the upfront payment over time based on a proportional performance model based on the costs incurred to date relative to the total costs expected to be incurred through the completion of the development of the Coronary in ISR indication, for which we arewere primarily responsible. We have recognized $14.6 million in cumulative partnership revenues from 2019 through December 31, 2024. There were no other proceeds received pursuant to the Terumo Agreement from 2019 through December 31, 2024.

In June 2022, Legacy Orchestra entered into the Medtronic Agreement for the development and commercialization of AVIM therapy for the treatment of pacemaker-indicated patients with uncontrolled HTN despite the use of anti-hypertensive medications. We have determined that the arrangement is a collaboration within the scope of ASC 808, Collaborative Arrangements (“ASC 808”). In addition, we concluded that Medtronic, Inc., an affiliate of Medtronic plc (“Medtronic”), is a customer for a good or service that is a distinct unit of account, and therefore, the transactions in the Medtronic Agreement, as amended pursuant to the Medtronic Agreement Amendment (the “Amended Medtronic Agreement”), should be accounted for under ASC 606. Through December 31, 2024,2025, there have been no amounts recognized as revenue under the Amended Medtronic Agreement.

Selling, general and administrative expenses consist of personnel-related expenses, including salaries, benefits, bonus, travel and stock-based compensation. Other selling, general and administrative expenses include professional services fees, including legal, audit investor/public relations, and insurance costs, outside consultants costs, employee recruiting and training costs, and non-income taxes. Moreover, we incur and expect to continue to incur additional expenses associated with operating as a public company, including legal, accounting, insurance, exchange listing and U.S. Securities and Exchange Commission (“SEC”) compliancecompliance, and investor relations.relations expenses. We expect annual selling, general and administrative expenses to continue to increase as we conduct additional clinical trials and expand our operations as a public company.

Interest (Expense) Income, Net

Interest income(expense) income, net reflects the income generated from marketable securities during the year. Interest expense is attributable to loan interest.interest and interest related to the Royalty Purchase Agreement.

On November 6, 2024 (the “LSA Closing Date”), we and certain of our subsidiaries (collectively, the “Borrower”) entered into a Loan and Security AgreementAgreement, by and among the Borrower, the several banks and other financial institutions or entities party thereto, as lenders (collectively, the “2024 LSA”), with Hercules Capital IV, L.P. (“Hercules IV”), Hercules SBIC V, L.P. (“Hercules VLenders”), and Hercules Capital, Inc.,Inc. (“Hercules”), as administrative agent and collateral agent (collectivelyfor withitself and the Hercules IVLenders, as amended by that certain First Amendment to Loan and HerculesSecurity V,Agreement dated as of December 30, 2024 ( “Hercules2024 LSA”). ThePrior to July 31, 2025, the 2024 LSA providesprovided a secured term loan facility of up to $50.0 million available in up to four tranches (collectively, the “Term Loans”), with the first tranche of $15.0 million drawn on the LSA Closing Date, and a second and third tranche of up to an aggregate of $15.0 million available upon achievement of certain performance and financing milestones. Additionally, we may havehad access to a fourth tranche of $20.0 million subject to future approval. On July 31, 2025, the Borrower, the Hercules Lenders and Hercules entered into the Second Amendment to the 2024 LSA, which, amended the 2024 LSA to, among other things, (i) delay the initial date upon which we must begin amortizing term loans under the 2024 LSA from (a) December 1, 2026 (with amortization payments delayed to as late December 1, 2027 if certain conditions were met) to (b) July 1, 2027 (with amortization payments delayed to as late as January 1, 2028 if certain conditions are met); (ii) increase by $15.0 million (from $20.0 million to $35.0 million) the amount that that may be borrowed by us in the discretion of the lender’s investment committee’s and (iii) eliminate our ability to draw up to $15.0 million if certain milestones are achieved. The Term Loan has a maturity date of November 6, 2028 and accrues interest at a floating per annum rate equal to the greater of (i) (x) the “prime rate” as reported in The Wall Street Journal plus (y) 2.0%, and (ii) 9.50%. Refer to Note 1516 – “Debt Financing” to our Consolidated Financial Statements.

The loss on fair value 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 Motuscommon GIstock Holdings,holdings Inc. (“Motus GI”),of a previously publicly-held company and a former related party.company. The investmentscommon in Vivasure do not have readily determinable fair values and are recorded at cost, less any impairment, plus or minus changes resulting from observable price changes in orderly transactions for identical or similar investments of the same issuer. The sharesstock held of Motus GI represented equity securities with a readily determinable fair value and were required to be measured at fair value at each reporting period using readily determinable pricing available on a securities exchange, in accordance with the provisions of ASU 2016-01. However, in second quarter of 2024, Motus GI announced a resolution to liquidate, at which time we concluded that the fair value should be zero and expensed the remaining carrying value of our investment in Motus GI.

Partnership revenue decreasedincreased by $101,000,$30.9 million, or approximately 5%,1539%, to $2.0$32.9 million in the year ended December 31, 20242025 from $2.1$2.0 million for the year ended December 31, 2023.2024. Partnership revenue relates partially 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. AsPartnership ofrevenue eachprimarily quarterlyrelates reportingto date,our entering into the Termination and ROFR Agreement with Terumo on October 28, 2025, for which we evaluatereceived our$30.0 estimatesmillion in exchange for providing a ROFR and issuing Series A Preferred Stock to Terumo. The Termination and ROFR Agreement superseded and terminated the Terumo Agreement, and we no longer have any performance obligations under the Terumo Agreement. In addition to recognizing the remainder of the totaldeferred costsrevenue, expectedpartnership torevenue be incurred throughfor the completionyear ended December 31, 2025 included $10.0 million in consideration for the ROFR and $7.4 million associated with the premium above the fair market value of the combinedSeries performanceA obligationPreferred and update our estimates as necessary.Stock.

Product revenue primarily consisted of the sale of FreeHold Duo and Trio intracorporeal organ retractors and revenue is recognized when product is shipped to customers. The decrease in product revenue was primarily due to a decrease in the purchase volume of FreeHold Duo and Trio intracorporeal organ retractors.volume. There were no changes to the per unit sale price in either period between the periods presented.

Cost of product revenue increaseddecreased by $18,000,$14,000, or approximately 10%,7%, to $204,000$190,000 in the year ended December 31, 20242025 from $186,000$204,000 for the year ended December 31, 2023.2024. The increasedecrease was primarily due to higherlower productionsales costs per unitvolume of FreeHold Duo and Trio intracorporeal organ retractors.

Research and development expenses increased by $9.0$15.4 million, or approximately 27%,36%, to $58.2 million for the year ended December 31, 2025 from $42.8 million for the year ended December 31, 2024 from $33.8 million for the year ended December 31, 2023.2024. This is primarily due to an increase in support of ongoing work to advance the BACKBEAT (BradycArdia paCemaKer with AVIM for Blood prEssure treAtmenT) global pivotal study (“BACKBEAT study”) and to advance Virtue SAB into athe plannedVirtue pivotalTrial, study.which commenced in October 2025. The increase included an increase of $4.1$4.9 million in clinical development costs, an increase in personnel-related expenses of $2.5$6.6 million due to increased headcount and consulting costs, an increase of $2.8 million in non-clinical development costs associated with research and development program costs, supplies, and testing, and an increase in personnel-related expenses of $1.5 million due to increased headcount and associated expenses, and an increase in stock-based compensation of $902,000.$1.1 million.

The total research and development expenses summarized above include $14.3 million for the year ended December 31, 2025 and $12.3 million for the year ended December 31, 2024 and $15.2 million for the year ended December 31, 2023 related to the Terumo Agreement. The decreaseincrease of $2.9$2.0 million is due to decreasedincreased expense activity related to the Terumo Agreement during the 20242025 period.

Selling, general and administrative expenses increased by $3.7$3.0 million, or approximately 18%,12%, to $23.9$26.9 million for the year ended December 31, 2024,2025, from $20.3$23.9 million of expense for the year ended December 31, 2023.2024. The increase primarily resulted from an increase in stock-based compensation of $2.1 million, an increase of $1.2$1.9 million ofin accounting, finance, legal, marketing, investor relations and public relations expenses incurred in connection with the overall growth of the business and operating as a public company, andexpenses, an increase in personnel-related expenses of $346,000$871,000 due to increased headcount and associatedconsulting expenses.costs, and an increase of $220,000 in stock-based compensation.

Interest (Expense) Income, Net

From inception through December 31, 2024,2025, we have incurred significant operating losses and negative cash flows from our operations. Our net losses were $61.0$52.7 million and $49.1$61.0 million for the years ended December 31, 20242025 and December 31, 2023,2024, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $309.9$362.6 million. We have funded our operations primarily through the issuance of common stock, convertible preferred stockstock, and warrants, as well as proceeds from the Business CombinationCombination, the prior Terumo Agreement and other equity sales, as well as through proceeds from the TerumoROFR and Termination Agreement, borrowings under debt arrangementsarrangements, and,the sale of future revenues, and to a lesser extent, revenue from FreeHold productproducts. revenue.As Throughof December 31, 2024,2025, we have raised a cumulative $252.3total of $356.5 million in gross proceeds through the issuance of convertible preferred stock, proceeds from the Business Combination and other equity sales, and have received $30.0 million under the Terumo Agreement.proceeds. We had $22.3$106.5 million in cash and cash equivalents and marketable securities at December 31, 2024,2025, whichcomprised of $34.7 million in cash and cash equivalents and $71.8 million in marketable securities. Cash and cash equivalents consisted primarily of bank deposits and money market funds.funds We also had $44.6 million ofwhile short-term marketable securities at December 31, 2024, which consisted primarily of our investments in corporate debt securities. Future committed cash receipts expected in April 2026 include $20.0 million from the Medtronic Loan Agreement, and an additional $15.0 million from Ligand pursuant to the Royalty Purchase Agreement. On January 9, 2026, Haemonetics closed on an acquisition of Vivasure in which we can receive up to $10.7 million of proceeds in 2026 made up of approximately $4.7 million upfront and approximately $6.0 million in a first milestone payment.

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 up284 toevaluable 316randomized patients with uncontrolled hypertensionHTN 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 thesethe patients,pacemaker asindicated wellgroup asstudied 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.

Virtue SAB is a highly differentiated, first-of-its-kind non-coated drug delivery angioplasty balloon 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 vs.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.

Since Orchestra BioMed, Inc.’s inception, we have devoted the substantial majority of our resources to performing 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, from product revenue from our subsidiary, FreeHold Surgical, LLC. (“FreeHold”). AsWe ofhad March 31, 2026, we have raised a cumulative $367.2$110.0 million in grosscash proceeds.and Incash Mayequivalents and marketable securities at June 30, 2026, wecomprised receivedof $20.0$20.5 million pursuantin tocash theand Medtroniccash Loanequivalents Agreementand (as$89.5 such term is definedmillion in Notemarketable 14 to the condensed consolidated financial statements – “Debt Financing”), and $15.0 million from Ligand pursuant to the revenue participation right purchase and sale agreement (the “Royalty Purchase Agreement”) we entered into with Ligand Pharmaceuticals Incorporated (“Ligand”)(see Note 13 to the condensed consolidated financial statements – “Royalty Purchase Agreement”).securities. We have incurred net losses each year since inception. Our net losses were $20.7$44.4 million and $18.8$38.1 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. We expect to continue to incur significant losses for the foreseeable future. As of MarchJune 31,30, 2026, we had an accumulated deficit of $383.3$407.0 million.

Orchestra BioMed, Inc., our wholly owned subsidiary, was incorporated in Delaware in 2017 and completed a recapitalization and mergers with Caliber Therapeutics, Inc., a Delaware corporation that has, among other things, the rights to the Virtue SAB product candidate and BackBeat Medical, Inc., (“BackBeat”) a Delaware Corporation that has, among other things, the rights to the AVIM Therapy product candidate, in 2018. Orchestra BioMed, Inc. completed the conversions of Caliber Therapeutics, Inc. to Caliber Therapeutics, LLC, a Delaware limited liability company, and BackBeat Medical, Inc. to BackBeat Medical, LLC, a Delaware limited liability company, in 2019.

We have determined that the arrangement set forth in the Medtronic Agreement as amended by the Medtronic Agreement Amendment (the “Amended Medtronic Agreement”) is a collaboration within the scope of ASC 808, Collaborative Arrangements (“ASC 808”). In addition, we concluded that Medtronic is a customer for a good or service that is a distinct unit of account, and therefore, the transactions set forth in the Amended Medtronic Agreement should be accounted for under ASC 606. Through MarchJune 31,30, 2026, there have been no amounts recognized as revenue under the Amended Medtronic Agreement.

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 23.3%21.2% as of MarchJune 31,30, 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.

Comparison of the ThreeSix Months Ended MarchJune 31,30, 2026 and 2025

The following table presents our statement of operations data for the threesix months ended MarchJune 31,30, 2026 and 2025, and the dollar and percentage change between the two periods (in thousands):

Partnership revenue decreased by $732,000,$1.4 million, or 100%, in the threesix months ended MarchJune 31,30, 2026 from $732,000$1.4 million for the threesix months ended MarchJune 31,30, 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.

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. For the threesix months ended MarchJune 31,30, 2025, the expenses incurred related to the Terumo Agreement were $3.5$6.8 million. The estimated total costs associated with the Terumo Agreement through completion as of MarchJune 31,30, 2025,2025 were approximately similar as compared to the estimates as of December 31, 2024.

Product revenue decreased by $26,000,$107,000, or approximately 19%,35%, to $110,000$198,000 in the threesix months ended MarchJune 31,30, 2026 from $136,000$305,000 for the threesix months ended MarchJune 31,30, 2025.

Cost of product revenue decreased by $12,000,$33,000, or approximately 27%,37%, to $32,000$57,000 in the threesix months ended MarchJune 31,30, 2026 from $44,000$90,000 for the threesix months ended MarchJune 31,30, 2025. The decrease was primarily due to lower sales volume of FreeHold Duo and Trio intracorporeal organ retractors.

The following table summarizes our research and development expenses for the threesix months ended MarchJune 31,30, 2026 and 2025 (in thousands):

Research and development expenses increased by $2.3$5.0 million, or approximately 17%,18%, to $15.8$32.4 million for the threesix months ended MarchJune 31,30, 2026 from $13.5$27.3 million for the threesix months ended MarchJune 31,30, 2025. This is primarily due to an increase in support of ongoing work to advance the BACKBEAT Trial and to advance Virtue SAB into the Virtue Trial. The increase included an increase in personnel-related expenses of $2.1$3.9 million due to increased headcount and consulting costs, an increase of $632,000$3.0 million in clinical development costs, partially offset by a decrease of $408,000$1.6 million in non-clinical development costs associated with research and development program costs, supplies, and testing.

The total research and development expenses summarized above include $3.5$6.8 million for the threesix months ended MarchJune 31,30, 2025 related to the Terumo Agreement, which was terminated in October 2025.

Selling, general and administrative expenses increaseddecreased by $110,000,$325,000, or approximately 2%,3%, to $6.4$12.2 million for the threesix months ended MarchJune 31,30, 2026, from $6.3$12.5 million of expense for the threesix months ended MarchJune 31,30, 2025. The increasedecrease primarily resulted from a decrease of $642,000 in stock-based compensation, partially offset by an increase of $168,000$288,000 in accounting, finance, and legal expenses partially offset by a decrease of $85,000 in stock-based compensation.expenses.

Interest (expense) income, net,net decreased by $1.0$2.7 million, or approximately 595%,2092%, to $821,000$2.6 million of interest expense for the threesix months ended MarchJune 31,30, 2026, from $166,000$130,000 of income for the threesix months ended MarchJune 31,30, 2025. The net interest expense in the 2026 period consisted primarily of monthly interest expense resulting from the 2024 LSALSA, 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.

The derivative liability of the Series A Preferred Stock was remeasured to a fair value of $2.8$2.5 million as of MarchJune 31,30, 2026. We recognized a lossgain of $35,000$289,000 for the threesix months ended MarchJune 31,30, 2026,2026 primarily drivendue byto an increasechanges in ourthe stockfair pricevalue comparedinputs toand assumptions used in the valuation model since the measurement at December 31, 2025.

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. In connection with the closing of the transaction, we canare eligible to receive up to approximately $10.7 million of proceeds in 2026 associated with the transaction. InDuring January,the six months ended June 30, 2026, we received the initial upfront paymentproceeds of $4.7$4.8 million and the remainder may be received in 2026 based on the achievement of a milestone. For the threesix months ended MarchJune 31,30, 2026, we recognized a gain on the sale of strategic investments of $2.2$2.3 million.

From inception through MarchJune 31,30, 2026, we have incurred significant operating losses and negative cash flows from our operations. Our net losses were $20.7$44.4 million and $18.8$38.1 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $383.3$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 inpursuant to which we canare eligible to receive up to $10.7 million of proceeds in 2026 made up of approximately $4.7$4.8 million already received upfront and approximately $6.0$5.9 million in a first milestone payment expected later this year. As of March 31, 2026, we have raised a cumulative $367.2 million in gross proceeds. We had $94.4$110.0 million in cash and cash equivalents and marketable securities at MarchJune 31,30, 2026, comprised of $28.4$20.5 million in cash and cash equivalents and $66.0$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. On May 1, 2026, we received $20.0 million pursuant to the Medtronic Loan Agreement and an additional $15.0 million from Ligand pursuant to the Royalty Purchase Agreement.

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 ramp up execution of the initiated Virtue Trial for Virtue SAB. The additional investmentExpenses will primarily support clinical study costs as well as other research and development activities.

Based on internally prepared budget estimates that reflect our operating priorities, we anticipate that our cash and cash equivalents, and marketable securities, proceeds received subsequent to March 31, 2026 but prior to the filing of this Quarterly Report on Form 10-Q,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.

Comparison of the ThreeSix Months Ended MarchJune 31,30, 2026 and 2025

Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2026 was $22.2$41.5 million and primarily consisted of our net loss of $20.7$44.4 million and changes in net operating assets and liabilities of $3.7$3.6 million, partially offset by non-cash charges of $2.2$6.5 million. Our non-cash charges primarily consisted of stock-based compensation of $2.9$5.4 million andmillion, non-cash interest expense on liability related to the Royalty Purchase Agreement of $1.3$3.1 million,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 $2.2$2.3 million. The net change in operating assets and liabilities was primarily due to ana increasedecrease in accounts payable, accrued expenses and other liabilities of $3.1$3.3 million and prepaidoperating expenseslease and other assetsliabilities of $477,000.$359,000.

Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2025 was $16.6$32.1 million and primarily consisted of our net loss of $18.8$38.1 million and changes in net operating assets and liabilities of $1.0 million,$632,000, partially offset by non-cash charges of $3.1$6.6 million. Our non-cash charges primarily consisted of stock-based compensation of $3.0$6.2 million, partially offset by $112,000$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 $732,000,$1.4 million offset by a decrease in accounts payable, accrued expenses and other liabilities of $202,000, and a decrease in operating lease liabilities of $132,000.$888,000.