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Navidea (NO1A) Risk Analysis

Public companies are required to disclose risks that can affect the business and impact the stock. These disclosures are known as “Risk Factors”. Companies disclose these risks in their yearly (Form 10-K), quarterly earnings (Form 10-Q), or “foreign private issuer” reports (Form 20-F). Risk factors show the challenges a company faces. Investors can consider the worst-case scenarios before making an investment. TipRanks’ Risk Analysis categorizes risks based on proprietary classification algorithms and machine learning. Navidea disclosed 36 risk factors in its most recent earnings report. Navidea reported the most risks in the “Finance & Corporate” category.

Risk Overview Q3, 2023

Source: the company's latest filing for the period ended Sep 30, 2023, filed Nov 14, 2023

Risk Distribution
36Risks
Sector Avg.Finance & CorporateTech & InnovationLegal & RegulatoryProductionAbility to SellMacro & Political
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy

Risk Change Over Time

Navidea disclosed risks per quarterNo. of Risks3334353637Q3Q4Q12023Q2Q3Showing: Q3, 2023
Risks removedRisks addedRisks changedNavidea Risk Factors
New Risk (1)
  • Share Price & Shareholder Rights - Risk 1
    The delisting of our Common Stock from NYSE American could have a material adverse effect on the liquidity and value of our Common Stock.

    On July 28, 2023, the Company received written notification from NYSE American stating that the staff of NYSE Regulation has determined to commence proceedings to delist the Company's Common Stock. NYSE Regulation has determined that the Company is no longer suitable for listing pursuant to Section 1009(a) of the NYSE American Company Guide as the Company was unable to demonstrate that it had regained compliance with Sections 1003(a)(i), (ii) and (iii) of the NYSE American Company Guide by the end of the maximum 18-month compliance plan period, which expired on July 28, 2023. The Company appealed the NYSE Regulation staff's decision to initiate delisting proceedings with respect to the Company's common stock but that decision was upheld. On October 5, 2023 trading of the Company's Common Stock on the NYSE American was suspended. On October 23, 2023, NYSE American filed a Form 25 with the SEC to delist the Company's common stock and the delisting was effective 10 days thereafter. As a result of the delisting of our Common Stock from NYSE American, we face significant material adverse consequences, including: - increased volatility in our Common Stock,- limited availability of market quotations for our Common Stock - reduced liquidity in our Common Stock,- limited amount of news and analyst coverage; and - the loss of the federal preemption of state securities laws and greater difficulty in issuing additional securities and obtaining financing In addition, delisting of our Common Stock could deter broker-dealers from making a market in or otherwise seeking or generating interest in our Common Stock, could result in a loss of current or future coverage by certain sell-side analysts and might deter certain institutions and persons from investing in its securities at all. Delisting could also cause a loss of confidence of the Company's collaborators, partners, suppliers and employees, which could harm our business and future prospects.

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Risk Highlights Q3, 2023

Main Risk Category
Finance & Corporate
With 14 Risks
Number of Disclosed Risks
36
+1
From last report
S&P 500 Average: 32
Recent Changes
1Risks added
0Risks removed
1Risks changed
Since Sep 2023
Number of Risk Changed
1
+1
From last report
S&P 500 Average: 1

Risk Word Cloud

our pharmaceutical products will remain subject to ongoing regulatory review following the receipt of marketing approval. if we fail to comply with continuing regulations, we could lose these approvals and the sale of our products could be suspended.receipt of marketing approvalif users of our products are unable to obtain adequate reimbursement from third-party payors, or if new restrictive legislation is adopted, market acceptance of our products may be limited and we may not achieve anticipated revenues.market acceptance of our productswe may not have sufficient legal protection against infringement or loss of our intellectual property, and we may lose rights or protection related to our intellectual property if diligence requirements are not met, or at the expiry of underlying patents.loss of our intellectual propertywe may never obtain regulatory approval to manufacture or market our unapproved drug candidates and our approval to market our products or anticipated commercial launch may be delayed as a result of the regulatory review process.obtain regulatory approval to manufacturethe company has experienced recurring net losses and has used significant cash to fund its operations, and we expect to continue to incur substantial operating losses and may be unable to obtain additional financing, and we may not be able to continue as a going concern.unable to obtain additional financingif users of our products are unable to obtain adequate reimbursement from third-party payors, or if new restrictive legislation is adopted, market acceptance of our products may be limited and we may not achieve anticipated revenues.unable to obtain adequate reimbursementif cardinal health 414, sayre therapeutics or sinotau do not achieve commercial success with tc99m tilmanocept, we may be unable to generate significant revenue from these relationships.unable to generate significant revenueour failure to maintain continued compliance with the listing requirements of the nyse american exchange could result in the delisting of our common stock.delisting of our common stockwe may never obtain regulatory approval to manufacture or market our unapproved drug candidates and our approval to market our products or anticipated commercial launch may be delayed as a result of the regulatory review process.market our unapproved drug candidatesthe price of our common stock has been, and may continue to be, highly volatile, and the value of your investment could decline significantly.price of our common stock

Risk Factors Full Breakdown - Total Risks 36

Share Price & Shareholder Rights8 | 22.2%
  • Share Price & Shareholder Rights - Risk 1Changed
    The delisting of our Common Stock from NYSE American could have a material adverse effect on the liquidity and value of our Common Stock.

    On July 28, 2023, the Company received written notification from NYSE American stating that the staff of NYSE Regulation has determined to commence proceedings to delist the Company's Common Stock. NYSE Regulation has determined that the Company is no longer suitable for listing pursuant to Section 1009(a) of the NYSE American Company Guide as the Company was unable to demonstrate that it had regained compliance with Sections 1003(a)(i), (ii) and (iii) of the NYSE American Company Guide by the end of the maximum 18-month compliance plan period, which expired on July 28, 2023. The Company appealed the NYSE Regulation staff's decision to initiate delisting proceedings with respect to the Company's common stock but that decision was upheld. On October 5, 2023 trading of the Company's Common Stock on the NYSE American was suspended. On October 23, 2023, NYSE American filed a Form 25 with the SEC to delist the Company's common stock and the delisting was effective 10 days thereafter. As a result of the delisting of our Common Stock from NYSE American, we face significant material adverse consequences, including: - increased volatility in our Common Stock,- limited availability of market quotations for our Common Stock - reduced liquidity in our Common Stock,- limited amount of news and analyst coverage; and - the loss of the federal preemption of state securities laws and greater difficulty in issuing additional securities and obtaining financing In addition, delisting of our Common Stock could deter broker-dealers from making a market in or otherwise seeking or generating interest in our Common Stock, could result in a loss of current or future coverage by certain sell-side analysts and might deter certain institutions and persons from investing in its securities at all. Delisting could also cause a loss of confidence of the Company's collaborators, partners, suppliers and employees, which could harm our business and future prospects.

  • Share Price & Shareholder Rights - Risk 2Added
    Trading in the over-the-counter market can be volatile and sporadic, which could depress the market price of our Common Stock and make it difficult for our stockholders to resell their shares.

    Our Common Stock is currently quoted on the Pink Tier of the OTC Markets. Trading in stock quoted on the over-the-counter market is often thin and characterized by wide fluctuations in trading prices due to many factors that may have little to do with our operations or business prospects. This volatility could depress the market price of our Common Stock for reasons unrelated to operating performance. Accordingly, our stockholders may have difficulty reselling any of their shares. The Company can provide no assurance whether broker-dealers will continue to provide public quotes of the Company's Common Stock on this market, whether the trading volume of the Company's Common Stock will be sufficient to provide for an efficient trading market or whether quotes for the Company's Common Stock will continue on this market in the future. The Company may consider relisting its Common Stock on a national securities exchange in the future if its Board of Directors determines that doing so is in the best interest of the Company and its stockholders. We cannot predict at this time whether such a decision will be made in the future, or what factors may come into play to lead to such a decision. If the Company were to relist its shares on a national securities exchange, our listing application would have to comply with the applicable initial listing requirements for such national securities exchange and applicable SEC rules.

  • Share Price & Shareholder Rights - Risk 3
    The market price of our Common Stock may be adversely affected by market conditions affecting the stock markets in general, including price and trading fluctuations on the NYSE American exchange.

    The market price of our Common Stock may be adversely affected by market conditions affecting the stock markets in general, including price and trading fluctuations on the NYSE American. These conditions may result in (i) volatility in the level of, and fluctuations in, the market prices of stocks generally and, in turn, our shares of Common Stock, and (ii) sales of substantial amounts of our Common Stock in the market, in each case that could be unrelated or disproportionate to changes in our operating performance.

  • Share Price & Shareholder Rights - Risk 4
    An investor's ability to trade our Common Stock may be limited by trading volume.

    During the 12-month period beginning on March 1, 2022 and ending on February 28, 2023, the average daily trading volume for our Common Stock on the NYSE American was approximately 182,000 shares. However, this trading volume may not be consistently maintained in the future. If the trading volume for our Common Stock decreases, there could be a relatively limited market for our Common Stock and the share price of our Common Stock would be more likely to be affected by broad market fluctuations, general market conditions, fluctuations in our operating results, changes in the market's perception of our business and announcements made by us, our competitors or parties with whom we have business relationships. There may also be fewer institutional investors willing to hold or acquire our Common Stock. Such a lack of liquidity in our Common Stock may make it difficult for us to issue additional securities for financing or other purposes or to otherwise arrange for any financing that we may need in the future.

  • Share Price & Shareholder Rights - Risk 5
    The price of our Common Stock has been, and may continue to be, highly volatile, and the value of your investment could decline significantly.

    Our Common Stock traded as low as $0.16 per share and as high as $1.24 per share during the 12-month period ended February 28, 2023. The following factors, some of which are beyond our control, may have a significant impact on the market price of our common stock: - the impact of the global COVID-19 pandemic on our business, financial condition or prospects, including a decline in the volume of procedures using our product, potential delays and disruptions to global supply chains, manufacturing activities, logistics, operations, employees and contractors, the business activities of our suppliers, distributors, customers and other business partners, as well as the effects on worldwide economies, financial markets, social institutions, labor markets and healthcare systems;- our history of operating losses and uncertainty of future profitability;- our ability to successfully complete research and further development of our drug candidates;- the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates, including delays and additional costs related to the ongoing COVID-19 pandemic;- our ability to successfully commercialize our drug candidates, including delays or disruptions related to the ongoing COVID-19 pandemic;- our ability to raise capital sufficient to fund our development programs, including unavailability of funds or delays in receiving funds as a result of the ongoing COVID-19 pandemic;- delays in receipt of anticipated proceeds from our capital funding transactions and other receivables;- our dependence on royalties and grant revenue;- our limited product line and distribution channels;- advances in technologies and development of new competitive products;- our ability to maintain effective control over financial reporting;- the outcome of any pending litigation; and - our ability to comply with NYSE American continued listing standards. These factors may materially and adversely affect the market price of our Common Stock, which could result in substantial losses by our investors. In addition, the stock market has experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of companies like ours. Broad market and industry factors may negatively affect the market price of our Common Stock, regardless of our actual operating performance. Further, a systemic decline in the financial markets and related factors beyond our control may cause our share price to decline rapidly and unexpectedly. Price volatility of our Common Stock might be worse if the trading volume of our ordinary shares is low.

  • Share Price & Shareholder Rights - Risk 6
    Raising additional capital may cause dilution to our stockholders or restrict our operations or require us to relinquish rights to our technologies or product candidates.

    Until such time, if ever, as we can generate substantial product revenue, we expect to obtain further funding through a combination of equity financings, debt financings, collaborations, licensing arrangements or other sources of financing, which may dilute our stockholders or restrict our operating activities. We do not have any committed external source of funds, and adequate additional financing may not be available to us on acceptable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholders' ownership interests will be diluted, and the terms may include liquidation or other preferences that adversely affect our stockholders' rights. Debt financing or preferred equity financings may result in imposition of covenants, increased fixed payment obligations or other restrictions that may affect our business. If we raise additional funds through upfront payments or milestone payments pursuant to strategic collaborations with third parties, we may have to relinquish valuable rights to product candidates or grant licenses on terms that are not favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. In addition, securing financing could require a substantial amount of time and attention from our management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely affect our management's ability to oversee the development of product candidates.

  • Share Price & Shareholder Rights - Risk 7
    Shares of Common Stock are subordinate to our existing and future indebtedness and preferred stock.

    Shares of our Common Stock are equity interests that rank junior to our Series G Preferred Stock, to our indebtedness and to all creditor claims and other non-equity claims against us and our assets available to satisfy claims on us, including claims in a bankruptcy or similar proceeding. Our future indebtedness and preferred stock may restrict payments of dividends on our Common Stock. Our amended and restated certificate of incorporation authorizes our board of directors to issue "blank check" preferred stock. This means our board of directors has the authority, without further action by our stockholders, to issue shares of preferred stock in one or more series and to set the terms and rights of the preferred stock. Any preferred stock that is issued may rank ahead of our Common Stock in terms of dividends and liquidation rights. If we issue additional shares of preferred stock in the future that has a preference over our Common Stock with respect to the payment of dividends or upon our liquidation, or if we issue additional shares of preferred stock with certain voting rights, the rights of holders of our Common Stock could be adversely affected. Additionally, unlike indebtedness, where principal and interest customarily are payable on specified due dates, in the case of our Common Stock, (i) dividends are payable only when and if declared by our Board of Directors or a duly authorized committee of our Board of Directors, and (ii) as a corporation, we are restricted to making dividend payments and redemption payments out of legally available assets. We have never paid a dividend on our Common Stock and have no current intention to pay dividends in the future. Furthermore, our Common Stock places no restrictions on our business or operations or on our ability to incur indebtedness or engage in any transactions, subject only to the voting rights available to shareholders generally.

  • Share Price & Shareholder Rights - Risk 8
    There may be future sales or other dilution of our equity, which may adversely affect the market price of shares of our Common Stock.

    Our existing convertible preferred stock, warrants or other securities convertible into or exchangeable for our Common Stock, or securities we may issue in the future, may contain adjustment provisions that could increase the number of shares issuable upon exercise, conversion or exchange, as the case may be, and decrease the exercise, conversion or exchange price. The market price of our shares of Common Stock could decline as a result of sales of a large number of shares of our Common Stock or other securities in the market, the triggering of any such adjustment provisions or the perception that such sales could occur in the future.

See a full breakdown of risk according to category and subcategory. The list starts with the category with the most risk. Click on subcategories to read relevant extracts from the most recent report.

FAQ

What are “Risk Factors”?
Risk factors are any situations or occurrences that could make investing in a company risky. The Securities and Exchange Commission (SEC) requires that publicly traded companies disclose their most significant risk factors. This is so that potential investors can consider any risks before they make an investment. They also offer companies protection, as a company can use risk factors as liability protection. This could happen if a company underperforms and investors take legal action as a result. It is worth noting that smaller companies, that is those with a public float of under $75 million on the last business day, do not have to include risk factors in their 10-K and 10-Q forms, although some may choose to do so.
How do companies disclose their risk factors?
Publicly traded companies initially disclose their risk factors to the SEC through their S-1 filings as part of the IPO process. Additionally, companies must provide a complete list of risk factors in their Annual Reports (Form 10-K) or (Form 20-F) for “foreign private issuers”. Quarterly Reports also include a section on risk factors (Form 10-Q) where companies are only required to update any changes since the previous report. According to the SEC, risk factors should be reported concisely, logically and in “plain English” so investors can understand them.
How can I use TipRanks risk factors in my stock research?
Use the Risk Factors tab to get data about the risk factors of any company in which you are considering investing. You can easily see the most significant risks a company is facing. Additionally, you can find out which risk factors a company has added, removed or adjusted since its previous disclosure. You can also see how a company’s risk factors compare to others in its sector. Without reading company reports or participating in conference calls, you would most likely not have access to this sort of information, which is usually not included in press releases or other public announcements. A simplified analysis of risk factors is unique to TipRanks.
What are all the risk factor categories?
TipRanks has identified 6 major categories of risk factors and a number of subcategories for each. You can see how these categories are broken down in the list below. 1. Financial & Corporate Accounting & Financial Operations - risks related to accounting loss, value of intangible assets, financial statements, value of intangible assets, financial reporting, estimates, guidance, company profitability, dividends, fluctuating results. Share Price & Shareholder Rights – risks related to things that impact share prices and the rights of shareholders, including analyst ratings, major shareholder activity, trade volatility, liquidity of shares, anti-takeover provisions, international listing, dual listing. Debt & Financing – risks related to debt, funding, financing and interest rates, financial investments. Corporate Activity and Growth – risks related to restructuring, M&As, joint ventures, execution of corporate strategy, strategic alliances. 2. Legal & Regulatory Litigation and Legal Liabilities – risks related to litigation/ lawsuits against the company. Regulation – risks related to compliance, GDPR, and new legislation. Environmental / Social – risks related to environmental regulation and to data privacy. Taxation & Government Incentives – risks related to taxation and changes in government incentives. 3. Production Costs – risks related to costs of production including commodity prices, future contracts, inventory. Supply Chain – risks related to the company’s suppliers. Manufacturing – risks related to the company’s manufacturing process including product quality and product recalls. Human Capital – risks related to recruitment, training and retention of key employees, employee relationships & unions labor disputes, pension, and post retirement benefits, medical, health and welfare benefits, employee misconduct, employee litigation. 4. Technology & Innovation Innovation / R&D – risks related to innovation and new product development. Technology – risks related to the company’s reliance on technology. Cyber Security – risks related to securing the company’s digital assets and from cyber attacks. Trade Secrets & Patents – risks related to the company’s ability to protect its intellectual property and to infringement claims against the company as well as piracy and unlicensed copying. 5. Ability to Sell Demand – risks related to the demand of the company’s goods and services including seasonality, reliance on key customers. Competition – risks related to the company’s competition including substitutes. Sales & Marketing – risks related to sales, marketing, and distribution channels, pricing, and market penetration. Brand & Reputation – risks related to the company’s brand and reputation. 6. Macro & Political Economy & Political Environment – risks related to changes in economic and political conditions. Natural and Human Disruptions – risks related to catastrophes, floods, storms, terror, earthquakes, coronavirus pandemic/COVID-19. International Operations – risks related to the global nature of the company. Capital Markets – risks related to exchange rates and trade, cryptocurrency.