Orchestra BioMed Holdings (OBIO) FY2025 10-K Risk Factors: 40 New, 14 Dropped

What the changes say

Orchestra BioMed continues to incur mounting net losses with substantial accumulated deficits.
Clinical studies for Virtue SAB, AVIM Therapy, CNT-HF, and SirolimusEFR face lengthy regulatory approval risks.
Operations depend heavily on attracting specialized personnel and managing IT systems.

What changed since the prior 10-K

New

NewRisks Related to Our Business and Products
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 it
We reported net losses of $52.7 million in 2025 and $61.0 million in 2024, resulting in an accumulated deficit of $362.6 million.
NewRisks Related to Our Business and Products
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 harmed
Developing device-led combination products like Virtue SAB, AVIM Therapy, CNT-HF, and SirolimusEFR involves lengthy and expensive clinical trials with uncertain outcomes.
NewRisks Related to Our Business and Products
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 position
Clinical failures or perceived conflicts of interest with principal investigators could delay regulatory approval and harm our reputation.
NewRisks Related to Our Business and Products
The FDA and comparable foreign regulatory authorities may not accept data from any preclinical or clinical trials we may conduct in foreign countries
Up to 50% of our BACKBEAT study data may come from foreign sites, which the FDA may not accept.
NewRisks Related to Our Business and Products
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-approval
Even if approved, our products may fail to achieve market acceptance by physicians, patients, and third-party payors.
NewRisks Related to Our Business and Products
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 provide
Our operating results may fluctuate significantly due to factors outside our control, including product demand and reimbursement policies.
NewRisks Related to Our Business and Products
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 condition
Long-term macroeconomic effects of pandemics, including supply chain disruptions and labor shortages, could impact our clinical studies.
NewRisks Related to Our Business and Products
Interim, “topline” 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 data
Preliminary or topline clinical data we announce may change following more comprehensive reviews and audit procedures.
NewRisks Related to Our Business and Products
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 candidates
We depend heavily on attracting and retaining key management and scientific personnel in a highly competitive industry.
NewRisks Related to Our Business and Products
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 business
Off-label use of our products by physicians could result in patient injury, product liability suits, or regulatory sanctions.
NewRisks Related to Our Business and Products
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 operations
We must successfully expand and upgrade our information technology systems to support our growth and avoid business disruptions.
NewRisks Related to Our Business and Products
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 regulations
Bringing cGMP product release testing for SirolimusEFR in-house subjects us directly to direct FDA and cGMP regulatory compliance risks.
NewRisks Related to Our Business and Products
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 success
NewRisks Related to Our Business and Products
Changes in tax laws could adversely affect the taxes we pay and, as a result, adversely affect our financial condition and results of operations
NewRisks Related to Our Reliance on Third Parties
The failure of our manufacturing partners and component suppliers to meet regulatory quality standards applicable to their manufacturing processes could have an adverse effect on our business, financial condition and results of operations
NewRisks Related to Our Reliance on Third Parties
From time to time, we engage outside parties to perform services related to certain of our clinical studies and trials, and any failure of those parties to fulfill their obligations could cause costs and delays
NewRisks Related to Our Reliance on Third Parties
The continuing development of many of our products and product candidates depends upon our maintaining strong working relationships with physicians
NewRisks Related to Our Reliance on Third Parties
We have limited pharmaceutical manufacturing experience and our CMOs may experience development or manufacturing problems or delays in producing our product candidates and planned or future products that could limit or prevent the potential growth of our revenue or increase our losses
NewRisks Related to Our Reliance on Third Parties
Reduction or interruption in supply and an inability to develop alternative sources for supply may adversely affect our partners’ manufacturing operations and related product sales
NewRisks Related to Our Reliance on Third Parties
We source certain products from foreign suppliers, making us vulnerable to supply problems or price fluctuations caused by trade conflicts and other geopolitical events
NewRisks Related to Our Reliance on Third Parties
As a result of these dynamics, we may find it difficult to predict the impact to our business of these and future changes to the trading relationships between the U.S. or other countries or the impact on our business of new laws or regulations adopted by the United States or other countries
NewRisks Related to Government Regulation and Our Industry
Regulatory compliance is expensive, complex and uncertain, and approvals or certifications can often be denied or significantly delayed. We may not obtain the necessary approvals or certifications and failure to obtain timely regulatory approval or certification, if at all, would adversely affect our business
NewRisks Related to Government Regulation and Our Industry
Our medical device products must be manufactured in accordance with federal, state and foreign regulations, and we or any of our suppliers or third-party manufacturers could be forced to recall our installed systems or terminate production if we fail to comply with these regulations
NewRisks Related to Government Regulation and Our Industry
Our relationships with physicians, patients and payors in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency, and other healthcare laws and regulations
NewRisks Related to Government Regulation and Our Industry
Actual or perceived failures to comply with U.S. and foreign privacy and data protection laws, regulations and standards may adversely affect our business, operations and financial performance
NewRisks Related to Government Regulation and Our Industry
We are subject to economic sanctions, export control, anti-bribery, anti-corruption and anti-money laundering laws, including the U.S. Foreign Corrupt Practices Act, and violations of these laws could result in substantial penalties and prosecution
NewRisks Related to Our Intellectual Property
We may not effectively be able to protect or enforce our intellectual property, which could have a material adverse effect on our business, financial condition, results of operations and prospects
NewRisks Related to Our Intellectual Property
Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets
NewRisks Related to Our Intellectual Property
We may be involved in litigation or other proceedings relating to patent, trade secret and other intellectual property rights, which could cause substantial costs and liability
NewRisks Related to Our Intellectual Property
Patents covering our technology or products could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad
NewRisks Related to Our Intellectual Property
We may be unable to acquire patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation
NewRisks Related to Our Intellectual Property
We may need to obtain intellectual property rights from third parties, and may not be successful in obtaining necessary rights to develop any future product through acquisitions and in-licenses
NewRisks Related to Our Intellectual Property
If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected
NewRisks Related to Ownership of Our Common Stock
Stockholder litigation and regulatory inquiries and investigations are expensive and could harm our business, financial condition and operating results and could divert management attention
NewRisks Related to Ownership of Our Common Stock
The price of our common stock has in the past been volatile and may continue to be volatile and subject to significant fluctuation
NewRisks Related to Ownership of Our Common Stock
If securities or industry analysts do not publish or cease publishing research or reports about us, our business, or our market, or if they change their recommendations regarding our securities adversely, the price and trading volume of our securities could decline
NewRisks Related to Ownership of Our Common Stock
Because we do not anticipate paying any cash dividends in the foreseeable future, capital appreciation, if any, would be your sole source of gain
NewRisks Related to Ownership of Our Common Stock
We are a smaller reporting company and the reduced reporting requirements applicable to smaller reporting companies may make our common stock less attractive to investors
NewRisks Related to Ownership of Our Common Stock
We may not be able to timely and effectively implement controls and procedures required by Section 404 of the Sarbanes-Oxley Act, which could have a material adverse effect on our business
NewRisks Related to Ownership of Our Common Stock
Changes in laws or regulations, or a failure to comply with any laws and regulations, may adversely affect our business, investments and results of operations

Dropped

DroppedRisks Related to Our Business and Products
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
DroppedRisks Related to Our Business and Products
additional preclinical studies or clinical studies. Any of these occurrences could have an adverse effect on our business, financial condition and results of operations
Disclosed cash and short-term marketable securities figures as of December 31, 2024.
DroppedRisks Related to Our Business and Products
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
DroppedRisks Related to Our Business and Products
Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved or certified, and could seriously harm our business
DroppedRisks Related to Our Reliance on Third Parties
the completion of negotiations. The Terumo Agreement provides that matters that are not resolved through mediation are to be resolved by binding arbitration conducted under the auspices of the ICDR in accordance with its International Arbitration Rules
Compliance with FDA, IRB, GCP, and cGMP requirements for clinical studies.
DroppedRisks Related to Our Reliance on Third Parties
If the mediation does not lead to an agreement or resolution, or, if applicable, we do not prevail in arbitration, or if the Terumo Agreement is terminated, our clinical study, product development, and commercialization plans for Virtue SAB may be further adversely impacted
DroppedRisks Related to Government Regulation and Our Industry
accountable care organizations. It is unclear what effect new quality and payment programs, such as MACRA, may have on our business, financial condition, results of operations or cash flows
Larger competitors having broader product lines and bundled purchase contracts.
DroppedRisks Related to Government Regulation and Our Industry
approvals or certifications; withdrawals or suspensions of current approvals or certifications, resulting in prohibitions on sales of our products; and, in the most serious cases, criminal penalties
DroppedRisks Related to Government Regulation and Our Industry
process, as well as coordination between two different centers within FDA responsible for review of the different components of the combination product
Dependence on attracting, retaining, and developing key personnel.
DroppedRisks Related to Government Regulation and Our Industry
additional mechanisms, at significant cost and diversion of management attention, to ensure compliance with the new data protection rules. This may be onerous and may adversely affect our business, operations and financial performance
DroppedRisks Related to Ownership of Our Common Stock
The price of our securities may be volatile
DroppedRisks Related to Our Operations in Israel
The research and development facilities of Motus GI Technologies, our wholly owned subsidiary and some of our suppliers are located in Israel and, therefore, our business, financial condition and results of operation may be adversely affected by political, economic and military instability in Israel
DroppedRisks Related to Our Operations in Israel
In particular, on October 7, 2023, war broke out between Israel and the terrorist organizations in the Gaza Strip, following a surprise attack on Israel led by certain armed groups in the Gaza Strip. To date, our operations in Israel have not been significantly impacted by the ongoing war
DroppedRisks Related to Our Operations in Israel
We may become subject to claims for payment of compensation for assigned service inventions by Motus GI Technologies’ current or former employees, which could result in litigation and adversely affect our business

Reworded

96% rewrittenRisks Related to Our Reliance on Third Parties
We and our partners may be unable to sustain revenue growth
Minor punctuation adjustment removing an Oxford comma in the description of FDA and foreign regulatory body authorizations.
96% rewrittenRisks Related to Government Regulation and Our Industry
Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay
Unchanged text content; minor formatting or processing artifact in the 10-K filing.
90% rewrittenRisks Related to Our Business and Products
The sizes of the markets for product candidates have not been established with precision and may be smaller than we estimate
Unchanged text content; minor formatting or processing artifact in the 10-K filing.
89% rewrittenRisks Related to Ownership of Our Common Stock
Our failure to meet Nasdaq’s continued listing requirements could result in a delisting of our common stock
Unchanged text content; minor formatting or processing artifact in the 10-K filing.
88% rewrittenRisks Related to Our Business and Products
We currently have product liability insurance for $6.0 million per occurrence with an annual aggregate maximum of $6.0 million
Unchanged text content; minor formatting or processing artifact in the 10-K filing.
85% rewrittenRisks Related to Our Intellectual Property
Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
Unchanged text content; minor formatting or processing artifact in the 10-K filing.
85% rewrittenRisks Related to Our Business and Products
If we do not achieve our projected development and commercialization goals, our business may be harmed
Removed specific references to the Terumo collaboration agreement and milestone dates from the description of development goals.
85% rewrittenRisks Related to Our Intellectual Property
If we cannot protect and control unpatented trade secrets, know-how and other proprietary technology, we may suffer competitive harm
Changed 'Interventional Therapies group intends to develop' to 'Interventional Therapies group may develop' regarding trade secrets.
82% rewrittenRisks Related to Government Regulation and Our Industry
Environmental and health safety laws may result in liabilities, expenses and restrictions on our operations
80% rewrittenRisks Related to Our Business and Products
We may be unable to compete successfully with larger companies in our highly competitive industry
58% rewrittenRisks Related to Government Regulation and Our Industry
Virtue SAB is a drug/device combination, which may result in additional regulatory and other risks
55% rewrittenRisks Related to Our Business and Products
These and other risks associated with our international operations may materially adversely affect our ability to attain or maintain profitable operations, which would have a material adverse effect on our business, financial condition and results of operations
54% rewrittenRisks Related to Government Regulation and Our Industry
Healthcare reform initiatives and other administrative and legislative proposals may adversely affect our business
52% rewrittenRisks Related to Our Business and Products
Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited
46% rewrittenRisks Related to Ownership of Our Common Stock
We face increased legal, accounting, administrative and other costs and expenses as a public company. These increased costs require us to divert a significant amount of money and management attention that could otherwise be used to expand the business and achieve strategic objectives
45% rewrittenRisks Related to Government Regulation and Our Industry
The aforementioned EU rules are generally applicable in the EEA (which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland). Non-compliance with the above requirements would also prevent us from selling our products in these countries
36% rewrittenRisks Related to Our Business and Products
We may need substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts
28% rewrittenRisks Related to Our Business and Products
Economic conditions may adversely affect our business, financial condition and share price
21% rewrittenRisks Related to Ownership of Our Common Stock
Moreover, in the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. If we face such litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business

All 72 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Business and Products

01We 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 itNew
02We may need substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts36% rewritten
03We currently have a limited operating history and limited sources of revenue and may never become profitable
04If we do not achieve our projected development and commercialization goals, our business may be harmed85% rewritten
05The 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 harmedNew
06Failures 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 positionNew
07The FDA and comparable foreign regulatory authorities may not accept data from any preclinical or clinical trials we may conduct in foreign countriesNew
08Even 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-approvalNew
09We may be unable to compete successfully with larger companies in our highly competitive industry80% rewritten
10Our 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 provideNew
11The sizes of the markets for product candidates have not been established with precision and may be smaller than we estimate90% rewritten
12The 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 conditionNew
13Interim, “topline” 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 dataNew
14We 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 candidatesNew
15If we make acquisitions, we could incur significant costs and encounter difficulties that harm our business
16If we do not manage our growth or control costs related to growth, our results of operations will suffer
17Litigation and other legal proceedings may adversely affect our business
18Product liability and other claims against us may reduce demand for our products or result in substantial damages
19We currently have product liability insurance for $6.0 million per occurrence with an annual aggregate maximum of $6.0 million88% rewritten
20The 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 businessNew
21We 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 operationsNew
22Economic conditions may adversely affect our business, financial condition and share price28% rewritten
23Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses
24These and other risks associated with our international operations may materially adversely affect our ability to attain or maintain profitable operations, which would have a material adverse effect on our business, financial condition and results of operations55% rewritten
25We 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 regulationsNew
26We 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 successNew
27Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited52% rewritten
28Changes in tax laws could adversely affect the taxes we pay and, as a result, adversely affect our financial condition and results of operationsNew

Risks Related to Our Reliance on Third Parties

29We and our partners may be unable to sustain revenue growth96% rewritten
30The failure of our manufacturing partners and component suppliers to meet regulatory quality standards applicable to their manufacturing processes could have an adverse effect on our business, financial condition and results of operationsNew
31From time to time, we engage outside parties to perform services related to certain of our clinical studies and trials, and any failure of those parties to fulfill their obligations could cause costs and delaysNew
32The continuing development of many of our products and product candidates depends upon our maintaining strong working relationships with physiciansNew
33We have limited pharmaceutical manufacturing experience and our CMOs may experience development or manufacturing problems or delays in producing our product candidates and planned or future products that could limit or prevent the potential growth of our revenue or increase our lossesNew
34Reduction or interruption in supply and an inability to develop alternative sources for supply may adversely affect our partners’ manufacturing operations and related product salesNew
35We source certain products from foreign suppliers, making us vulnerable to supply problems or price fluctuations caused by trade conflicts and other geopolitical eventsNew
36As a result of these dynamics, we may find it difficult to predict the impact to our business of these and future changes to the trading relationships between the U.S. or other countries or the impact on our business of new laws or regulations adopted by the United States or other countriesNew

Risks Related to Government Regulation and Our Industry

37Healthcare reform initiatives and other administrative and legislative proposals may adversely affect our business54% rewritten
38Regulatory compliance is expensive, complex and uncertain, and approvals or certifications can often be denied or significantly delayed. We may not obtain the necessary approvals or certifications and failure to obtain timely regulatory approval or certification, if at all, would adversely affect our businessNew
39The aforementioned EU rules are generally applicable in the EEA (which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland). Non-compliance with the above requirements would also prevent us from selling our products in these countries45% rewritten
40Our medical device products must be manufactured in accordance with federal, state and foreign regulations, and we or any of our suppliers or third-party manufacturers could be forced to recall our installed systems or terminate production if we fail to comply with these regulationsNew
41If any of these events occur, our reputation could be harmed, we could be exposed to product liability claims and we could lose customers and experience reduced sales and increased costs
42Virtue SAB is a drug/device combination, which may result in additional regulatory and other risks58% rewritten
43Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay96% rewritten
44Our relationships with physicians, patients and payors in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency, and other healthcare laws and regulationsNew
45Actual or perceived failures to comply with U.S. and foreign privacy and data protection laws, regulations and standards may adversely affect our business, operations and financial performanceNew
46Environmental and health safety laws may result in liabilities, expenses and restrictions on our operations82% rewritten
47We are subject to economic sanctions, export control, anti-bribery, anti-corruption and anti-money laundering laws, including the U.S. Foreign Corrupt Practices Act, and violations of these laws could result in substantial penalties and prosecutionNew

Risks Related to Our Intellectual Property

48We may not effectively be able to protect or enforce our intellectual property, which could have a material adverse effect on our business, financial condition, results of operations and prospectsNew
49We may be unable to enforce our intellectual property rights throughout the world
50If we cannot protect and control unpatented trade secrets, know-how and other proprietary technology, we may suffer competitive harm85% rewritten
51Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secretsNew
52We may be involved in litigation or other proceedings relating to patent, trade secret and other intellectual property rights, which could cause substantial costs and liabilityNew
53Patents covering our technology or products could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroadNew
54Obtaining and maintaining our patent protection depends on compliance with various procedural measures, document submissions, fee payments and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
55Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products
56Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time85% rewritten
57We may be unable to acquire patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislationNew
58We may need to obtain intellectual property rights from third parties, and may not be successful in obtaining necessary rights to develop any future product through acquisitions and in-licensesNew
59If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affectedNew

Risks Related to Ownership of Our Common Stock

60Stockholder litigation and regulatory inquiries and investigations are expensive and could harm our business, financial condition and operating results and could divert management attentionNew
61Anti-takeover provisions contained in our Charter and our Bylaws and under Delaware law could impair a takeover attempt
62The price of our common stock has in the past been volatile and may continue to be volatile and subject to significant fluctuationNew
63Moreover, in the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. If we face such litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business21% rewritten
64Sales of a substantial number of shares of our common stock in the public market could occur at any time. If our existing stockholders sell substantial amounts of common stock in the public market, or the market perceives that they intend to do so, the market price of our common stock could decline
65Our warrants may not be exercised at all and we may not receive any cash proceeds from the exercise of the warrants
66Our failure to meet Nasdaq’s continued listing requirements could result in a delisting of our common stock89% rewritten
67If securities or industry analysts do not publish or cease publishing research or reports about us, our business, or our market, or if they change their recommendations regarding our securities adversely, the price and trading volume of our securities could declineNew
68Because we do not anticipate paying any cash dividends in the foreseeable future, capital appreciation, if any, would be your sole source of gainNew
69We are a smaller reporting company and the reduced reporting requirements applicable to smaller reporting companies may make our common stock less attractive to investorsNew
70We may not be able to timely and effectively implement controls and procedures required by Section 404 of the Sarbanes-Oxley Act, which could have a material adverse effect on our businessNew
71We face increased legal, accounting, administrative and other costs and expenses as a public company. These increased costs require us to divert a significant amount of money and management attention that could otherwise be used to expand the business and achieve strategic objectives46% rewritten
72Changes in laws or regulations, or a failure to comply with any laws and regulations, may adversely affect our business, investments and results of operationsNew

Other Orchestra BioMed Holdings 10-Ks

FY2024 10-K risk factors
46 risks
Company is a clinical-stage medical technology business facing substantial capital requirements for studies like BACKBEAT and Virtue ISR-US. Operations depend heavily on partnerships such as Terumo, Medtronic, and Haemonetics. Product candidates like Virtue SAB face complex drug-device combination regulatory pathways.
Filed Mar 31, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.