BioCardia (BCDA) risk factors, FY2024 10-K

Risks Relating to Our Business, Financial Condition and Capital Requirements

1. 01We have a history of operating losses, and we may not be able to achieve or sustain profitability
2. 02We will require substantial additional financing to achieve our goals, and our failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development or commercialization efforts
3. 03seek to attract and retain skilled personnel
4. 04Our existing and any future contractual arrangement that we expect will provide us access to capital may provide less capital than expected and on a delayed basis
5. 05Our cash and cash equivalents could be adversely affected if the financial institutions in which we hold our cash and cash equivalents fail
6. 06Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited

Risks Relating to Development and Commercialization

1. 07Our success depends in large part on our ability to obtain approval for, and successfully commercialize, the CardiAMP Cell Therapy System
2. 08Because the CardiAMP Cell Therapy System is, to our knowledge, the first cardiac cell-based therapy with an accepted pivotal trial that is to be regulated by the FDA via the premarket approval pathway, the approval process for the CardiAMP Cell Therapy System is uncertain
3. 09We have encountered, and may in the future encounter, substantial delays in our clinical studies
4. 10disagreements between us and the FDA or other regulatory agencies interpreting the data from our clinical trials, including the determination from the DSMB to recommend pausing our Phase III pivotal CardiAMP Cell Therapy Trial pending the one-year follow-up outcomes analysis
5. 11We may find it difficult to enroll patients in our clinical trials, which could delay or prevent development of our therapeutic candidates
6. 12the degree of treatment effect in event-driven trials
7. 13We depend on our license and distribution agreement with Biomet Biologics, LLC, and if we fail to comply with our obligations under this agreement, or if our rights under this agreement are otherwise reduced or terminated, we could lose intellectual property rights that are important to our business
8. 14We rely on third parties to conduct some or all aspects of our product manufacturing, diagnostic protocol development, research, and preclinical and clinical testing, and these third parties may not perform satisfactorily
9. 15disruptions to the operations of our third-party manufacturers or suppliers caused by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier
10. 16We depend on third-party vendors to manufacture some of our components and sub-assemblies, which could make us vulnerable to supply shortages and price fluctuations that could harm our business
11. 17delays in delivery by our suppliers due to changes in demand from us or their other customers
12. 18Our future commercial success depends upon attaining significant market acceptance of our therapeutic candidates, if approved, among physicians, patients and healthcare payors
13. 19the effectiveness of our sales and marketing efforts
14. 20Our ability to compete is highly dependent on demonstrating the benefits of CardiAMP to physicians, hospitals and patients
15. 21We face substantial competition, which may result in others discovering, developing or commercializing products before, or more successfully, than we do
16. 22If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our therapeutic candidates, if approved, we may be unable to generate any revenues
17. 23integrating a new business unit into an existing corporate architecture
18. 24We have limited experience manufacturing our therapeutic candidates or products in commercial quantities, which could harm our business
19. 25If we fail to obtain and sustain an adequate level of reimbursement for our products by third-party payors, sales and profitability would be adversely affected
20. 26We work with outside scientists and their institutions in developing therapeutic candidates and products. These scientists may have other commitments or conflicts of interest, which could limit our access to their expertise
21. 27collect data and biological samples from trial participants periodically in accordance with our study protocols
22. 28If the market opportunities for our therapeutic candidates or products are smaller than we believe they are, our revenues may be adversely affected, and our business may suffer

Risks Relating to Government Regulation, Compliance and Litigation

1. 29Even if we obtain regulatory approval for a product candidate, including our autologous CardiAMP Cell Therapy System, CardiALLO allogeneic MSC therapy and other therapeutic candidates, these products or therapies, along with our other regulated products, will be subject to ongoing regulatory scrutiny
2. 30injunctions or the imposition of civil or criminal penalties by FDA or other regulatory bodies
3. 31We may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory agencies
4. 32If we fail to obtain and maintain necessary regulatory clearances or approvals for our therapeutic candidates or products, or if clearances or approvals for our therapeutic candidates or products in additional indications are delayed or not issued, our commercial operations would be harmed
5. 33Serious adverse events or other safety risks could require us to abandon development and preclude, delay or limit approval of our therapeutic candidates or products or limit the scope of any approved indication or market acceptance
6. 34our reputation may suffer
7. 35Our therapeutic candidates are intended to treat patients who are extremely ill, and patient deaths that occur in our clinical trials could negatively impact our business even if they are not shown to be related to our therapeutic candidates
8. 36If we or our suppliers fail to comply with the FDA’s QSRs, or QMSR when it goes into effect, our manufacturing operations could be delayed or shut down and product sales could suffer
9. 37The requirements to obtain regulatory approval of the FDA and regulators in other jurisdictions can be costly, time-consuming, and unpredictable. If we are unable to obtain timely regulatory approval for our therapeutic candidates, our business may be substantially harmed
10. 38the approval policies or regulations of the FDA or other regulatory authorities outside of the United States may significantly change in a manner rendering our clinical data insufficient for approval
11. 39Even if we obtain and maintain approval for our therapeutic candidates or products from the FDA, we may never obtain approval for our therapeutic candidates or products outside of the United States, which would limit our market opportunities and adversely affect our business
12. 40We may face competition from biosimilars due to changes in the regulatory environment
13. 41We are subject to significant regulation and oversight in the United States. Our failure to comply with these laws could harm our results of operations and financial condition
14. 42Restrictive laws and regulations govern the collection, use, transfer, and other processing of personal information
15. 43A recall of any of our commercialized products, or the discovery of serious safety issues, could have a significant negative impact on us
16. 44Modifications to our products may require reclassifications, new regulatory approvals or clearances, or may require us to cease marketing or recall the modified products until new CE marking is obtained
17. 45The use, misuse or off-label use of our products or therapies, if approved, may result in injuries that lead to product liability suits, which could be costly to our business
18. 46Our employees, principal investigators, consultants and collaboration partners may engage in misconduct or other improper activities, including noncompliance with laws and regulatory standards and requirements and insider trading
19. 47Price controls may be imposed in foreign markets, which may adversely affect our future profitability
20. 48If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our therapeutic candidates or products
21. 49a decline in our share price

Risks Related to the Operation of Our Business

1. 50If we fail to attract and keep senior management and key scientific personnel, we may be unable to successfully develop our therapeutic candidates, conduct our clinical trials and commercialize our therapeutic candidates
2. 51We will need to expand our organization and we may experience difficulties in managing this growth, which could disrupt our operations
3. 52Our business and operations would suffer in the event of system failures
4. 53Interruptions in supply or inventory loss may adversely affect our operating results and financial condition
5. 54We or the third parties upon whom we depend may be adversely affected by earthquakes or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster
6. 55Our financial controls and procedures may not be sufficient to accurately or timely report our financial condition or results of operations, which may adversely affect investor confidence in us and, as a result, the value of our Common Stock
7. 56the possibility that any enhancements to controls and procedures may still not be adequate to assure timely and accurate financial information

Risks Relating to Our Intellectual Property

1. 57We may not be able to protect our proprietary technology in the marketplace
2. 58The patent protection of biotherapeutics is complex and uncertain
3. 59We may be unable to adequately prevent disclosure of trade secrets and other proprietary information
4. 60We may be forced to litigate to enforce or defend our intellectual property rights, and/or the intellectual property rights of our licensors
5. 61Intellectual property disputes could cause us to spend substantial resources and distract our personnel from their normal responsibilities
6. 62Patent reform legislation and recent court decisions could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents
7. 63If third parties claim that our therapeutic candidates or other products infringe upon their intellectual property, commercialization of our therapeutic candidates or products and our operating profits could be adversely affected
8. 64If we do not obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the term of our marketing exclusivity of our therapeutic candidates or products, our business may be materially harmed
9. 65Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed

Risks Related to Our Securities

1. 66Our failure to meet the continued listing requirements of the Nasdaq could result in a de-listing of our common stock
2. 67The market price and trading volume of our securities may be volatile and may be affected by economic conditions beyond our control
3. 68If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock, the price and trading volume of our securities could decline
4. 69Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval
5. 70As a smaller reporting company, we are subject to scaled disclosure requirements that may make it more challenging for investors to analyze our results of operations and financial prospects
6. 71We may be exposed to additional risks as a result of our reverse merger transaction
7. 72Our annual and quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline
8. 73the changing and volatile U.S., European and global economic environments, including inflationary pressures and increased federal interest rates
9. 74Raising additional funds through debt or equity financing could be highly dilutive and may cause the market price of our common stock to decline
10. 75Sales of a substantial number of shares of our common stock or rights to purchase our common stock could cause our stock price to fall
11. 76Future sales and issuances of our common stock or rights to purchase our common stock, including pursuant to the HCW Sales Agreement or under our equity incentive plans, could result in additional dilution of the percentage ownership of our existing stockholders and could cause our stock price to fall
12. 77We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock

General Risks

1. 78If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business
2. 79We are at risk of securities class action litigation