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Veru (FMW0) 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. Veru disclosed 58 risk factors in its most recent earnings report. Veru reported the most risks in the “Finance & Corporate” category.

Risk Overview Q2, 2025

Source: the company's latest filing for the period ended Jun 30, 2025, filed Aug 12, 2025

Risk Distribution
58Risks
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

Veru disclosed risks per quarterNo. of Risks56.755757.2557.557.755858.25Q4Q12025Q2Showing: Q2, 2025
Risks removedRisks addedRisks changedVeru Risk Factors
Risk Changed (7)
  • Share Price & Shareholder Rights - Risk 1
    If our stock price declines, we may be subject to delisting from the Nasdaq Capital Market.

    Rule 5550(a)(2) of the Nasdaq Listing Rules requires the closing bid price of our common stock to be greater than $1.00 per share.  On August 29, 2024, we received a letter (the "Original Deficiency Letter") from The Nasdaq Stock Market, LLC ("Nasdaq") notifying us that we had fallen below compliance with this listing standard and providing us with a period of 180 calendar days from the date of notification to regain compliance with the minimum bid price requirement, which was subsequently extended to August 25, 2025.  On August 8, 2025, we effected a 1-for-10 reverse stock split of all of our issued and outstanding shares of common stock (the "Reverse Stock Split").  In order to regain compliance with the minimum bid price requirement, the closing bid price of our common stock after the Reverse Stock Split must exceed $1.00 per share for a period of ten consecutive trading days. Even if we regain compliance with the minimum bid price requirement, if the closing bid price of our common stock subsequently is less than $1.00 per share for 10 consecutive trading days, we may receive another deficiency letter from Nasdaq stating that our common stock will be delisted unless we are able to regain compliance with the minimum bid price requirement.  We cannot assure you that our stock price will continue to trade above $1.00 per share or otherwise meet the Nasdaq listing requirements and therefore our common stock may in the future be subject to delisting. The continuing effect of the Reverse Stock Split on the market price of our common stock cannot be predicted with any certainty, and the history of similar reverse stock splits for companies in like circumstances is varied. If Nasdaq delists our shares of common stock from trading on its exchange for failure to meet Nasdaq's listing standards, we and our stockholders could face significant material adverse consequences including: - a limited availability of market quotations for our shares;- reduced liquidity for our shares;- a determination that our common stock is a "penny stock" which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our shares;- a limited amount of news and analyst coverage; and - a decreased ability to issue additional securities or obtain additional financing in the future.

  • Accounting & Financial Operations - Risk 2
    We currently have no commercial revenue and may never generate revenue or become profitable.

    After the completion of the FC2 Business Sale on December 30, 2024, we do not currently have any source of revenue. Our ability to generate revenue and become profitable depends upon our ability to obtain regulatory approval for, and successfully commercialize, our product candidates that we may develop, in-license or acquire in the future. Even if we are able to successfully achieve regulatory approval for any of our product candidates, we do not know what the reimbursement status of our product candidates will be or when any of these products will generate revenue for us, if at all. We do not expect to generate any revenue from our product candidates for the foreseeable future, and we expect to continue to incur significant operating losses for the foreseeable future due to the cost of research and development, preclinical studies and clinical trials and the regulatory approval process for our product candidates. The amount of future losses is uncertain and will depend, in part, on the rate of growth of our expenses. Our ability to generate revenue from our product candidates also depends on a number of additional factors, including our ability to: - successfully complete development activities, including any remaining preclinical studies and ongoing and planned clinical trials for our product candidates;- complete and submit NDAs to the FDA and any applicable applications to foreign regulatory authorities, and obtain regulatory approval for indications for which there is a commercial market;- manufacture any approved products in commercial quantities and on commercially reasonable terms;- develop a commercial organization, or find suitable partners, to market, sell and distribute approved products in the markets in which we have retained commercialization rights;- achieve acceptance among patients, clinicians, and advocacy groups for any products we develop;- obtain coverage and adequate reimbursement from third parties, including government payors; and - set a commercially viable price and obtain reasonable price increases over time for any products for which we may receive approval. We are unable to predict the timing or amount of increased expenses, or when or if we will be able to achieve or maintain profitability. Even if we are able to complete the processes described above, we anticipate incurring significant costs associated with commercializing our product candidates.

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Risk Highlights Q2, 2025

Main Risk Category
Finance & Corporate
With 22 Risks
Number of Disclosed Risks
58
No changes from last report
S&P 500 Average: 32
Recent Changes
6Risks added
14Risks removed
7Risks changed
Since Jun 2025
Number of Risk Changed
7
No changes from last report
S&P 500 Average: 1

Risk Word Cloud

if we fail to obtain additional capital, we may need to reduce the scope of our development programs or we could be forced to share our rights to technologies with third parties on terms that may not be favorable to us.scope of our development programswe may face claims that our intellectual property infringes on the intellectual property rights of third parties. if we infringe intellectual property rights of third parties, it may increase our costs or prevent us from being able to commercialize our product candidates.to commercialize our product candidatesour drug products may be subject to governmental pricing controls.subject to governmental pricing controlswe may need to file lawsuits or take other actions to protect or enforce our intellectual property rights.enforce our intellectual property rightsownership in our common stock is highly concentrated and your ability to influence corporate matters may be limited as a result.ability to influence corporate mattersthe fda issued a final order reclassifying female condoms as class ii medical devices, which may result in increased competition for fc2 in the u.s. market.final order reclassifying female condomswe may fail to protect the confidentiality of commercially sensitive information.confidentiality of commercially sensitive informatwe intend to rely on cros to conduct our research and development activities.cros to conduct our researchsince we sell fc2 in foreign markets, we are subject to international business risks that could adversely affect our operating results.adversely affect our operating resultswe may be unable to protect the proprietary nature of the intellectual property covering our products.intellectual property covering our products

Risk Factors Full Breakdown - Total Risks 58

Share Price & Shareholder Rights7 | 12.1%
  • Share Price & Shareholder Rights - Risk 1Added
    If our stock price declines, we may be subject to delisting from the Nasdaq Capital Market.

    Rule 5550(a)(2) of the Nasdaq Listing Rules requires the closing bid price of our common stock to be greater than $1.00 per share.  On August 29, 2024, we received a letter (the "Original Deficiency Letter") from The Nasdaq Stock Market, LLC ("Nasdaq") notifying us that we had fallen below compliance with this listing standard and providing us with a period of 180 calendar days from the date of notification to regain compliance with the minimum bid price requirement, which was subsequently extended to August 25, 2025.  On August 8, 2025, we effected a 1-for-10 reverse stock split of all of our issued and outstanding shares of common stock (the "Reverse Stock Split").  In order to regain compliance with the minimum bid price requirement, the closing bid price of our common stock after the Reverse Stock Split must exceed $1.00 per share for a period of ten consecutive trading days. Even if we regain compliance with the minimum bid price requirement, if the closing bid price of our common stock subsequently is less than $1.00 per share for 10 consecutive trading days, we may receive another deficiency letter from Nasdaq stating that our common stock will be delisted unless we are able to regain compliance with the minimum bid price requirement.  We cannot assure you that our stock price will continue to trade above $1.00 per share or otherwise meet the Nasdaq listing requirements and therefore our common stock may in the future be subject to delisting. The continuing effect of the Reverse Stock Split on the market price of our common stock cannot be predicted with any certainty, and the history of similar reverse stock splits for companies in like circumstances is varied. If Nasdaq delists our shares of common stock from trading on its exchange for failure to meet Nasdaq's listing standards, we and our stockholders could face significant material adverse consequences including: - a limited availability of market quotations for our shares;- reduced liquidity for our shares;- a determination that our common stock is a "penny stock" which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our shares;- a limited amount of news and analyst coverage; and - a decreased ability to issue additional securities or obtain additional financing in the future.

  • Share Price & Shareholder Rights - Risk 2Changed
    There are provisions in our charter documents and Wisconsin law that might prevent or delay a change in control of our company.

    We are subject to a number of provisions in our charter documents and Wisconsin law that may discourage, delay, or prevent a merger or acquisition that a shareholder may consider favorable. These provisions include the following: - the authority provided to our Board of Directors in our Amended and Restated Articles of Incorporation to issue preferred stock without further action by our shareholders;- the provision under Wisconsin law that permits shareholders to act by written consent only if such consent is unanimous;- the provision under Wisconsin law that requires for a corporation such as us, that was formed before January 1, 1973, the affirmative vote of the holders of at least two-thirds of the outstanding shares of our voting stock to approve an amendment to our articles of incorporation, a merger submitted to a vote of our shareholders, or a sale of substantially all of our assets;- advance notice procedures for nominations of candidates for election as directors and for shareholder proposals to be considered at shareholders' meetings; and - the Wisconsin control share acquisition statute and Wisconsin's "fair price" and "business combination" provisions which limit the ability of an acquiring person to engage in certain transactions or to exercise the full voting power of acquired shares under certain circumstances.

  • Share Price & Shareholder Rights - Risk 3
    We have been named a defendant in stockholder class actions. These, and potential similar or related lawsuits or investigations, could result in substantial legal fees, fines, penalties or damages and may divert management's time and attention from our business.

    On December 5, 2022, a putative securities class action complaint was filed in federal district court for the Southern District of Florida against us certain of our current officers and directors. The amended complaint alleges that certain public statements about sabizabulin as a treatment for COVID-19 between March 1, 2021 and March 2, 2023 violated Sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder, and seeks monetary damages. We and certain of our offices and directors are also parties to four derivative actions asserting state law claims primarily in connection with the issues and claims asserted in the securities class action. These legal proceedings and any other similar or related legal proceedings are subject to inherent uncertainties, and the actual costs to be incurred relating to these matters will depend upon many unknown factors. The outcome of these legal proceedings is uncertain, and we could be forced to expend significant resources in the defense of these actions, and we may not prevail. Although we have insurance coverage for these actions, we have a $5 million retention amount, which means that we are responsible for the first $5 million of costs or damages relating to these actions, and as a result must pay for any defense costs ourselves up to such retention amount before any insurance coverage will apply. Monitoring and defending against legal actions is time-consuming for management and detracts from our ability to fully focus our internal resources on our business activities. In addition, we may incur substantial legal fees and costs in connection with these matters. We are also generally obligated, to the extent permitted by law, to indemnify our current and former directors and officers who are named as defendants in these and similar actions. We are not currently able to estimate the possible cost to us from these matters, as these actions are currently at an early stage and we cannot be certain how long it may take to resolve these matters or the possible amount of any damages that we may be required to pay. It is possible that we could, in the future, incur judgments or enter into settlements of claims for monetary damages. Decisions adverse to our interests in these actions could result in the payment of substantial damages, and could have a material adverse effect on our cash flow, results of operations and financial position. These and additional legal proceedings may also increase the costs of, or result in adverse changes in, our director and officer insurance coverage, and if we are unable in the future to obtain an acceptable level of director and officer insurance coverage we may face challenges in recruiting or retaining qualified independent directors or officers.

  • Share Price & Shareholder Rights - Risk 4
    Ownership in our common stock is highly concentrated and your ability to influence corporate matters may be limited as a result.

    As of August 7, 2025, our executive officers and directors collectively beneficially owned approximately 15.3% of the outstanding shares of our common stock, including approximately 6.8% beneficially owned by Mitchell Steiner, M.D., our Chairman, President and Chief Executive Officer, and 6.2% beneficially owned by Harry Fisch, M.D., our Vice Chairman and Chief Corporate Officer. These shareholders may have the ability to exert significant influence over the outcome of shareholder votes, including votes concerning director elections, amendments to our Amended and Restated Articles of Incorporation and other significant corporate transactions. In addition, this concentration of ownership may have the effect of delaying, deferring or preventing a change in control, impeding a merger, consolidation, takeover or other business combination involving us, or discouraging a potential acquiror from making a tender offer or otherwise attempting to obtain control of our business, even if such a transaction would benefit other stockholders. The interests of such stockholders may not always coincide with your interests or the interests of other stockholders and they may act in a manner that advances their best interests and not necessarily those of other stockholders.

  • Share Price & Shareholder Rights - Risk 5
    We are a "smaller reporting company" and will be able to avail ourselves of reduced disclosure requirements applicable to smaller reporting companies, which could make our common stock less attractive to investors.

    We are a "smaller reporting company," as defined in the Exchange Act, and we intend to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not "smaller reporting companies," including reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements. We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile. We may take advantage of these reporting exemptions until we are no longer a "smaller reporting company." We will remain a "smaller reporting company" until (a) the aggregate market value of our outstanding common stock held by non-affiliates as of the last business day of our most recently completed second fiscal quarter is $250 million or more and we reported annual net revenues as of our most recently completed fiscal year is $100 million or more, or (b) the aggregate market value of our outstanding common stock held by non-affiliates as of the last business day of our most recently completed second fiscal quarter is $700 million or more, regardless of annual revenue.

  • Share Price & Shareholder Rights - Risk 6
    The trading price of our common stock has been volatile, and investors in our common stock may experience substantial losses.

    The trading price of our common stock has been volatile and may continue to be volatile. The trading price of our common stock could decline or fluctuate in response to a variety of factors, including: - our failure to meet market expectations for our performance;- the timing of announcements by us or our competitors concerning significant product developments, acquisitions, or financial performance;- adverse results or delays in our clinical trials for our drug candidates;- changes in laws or regulations applicable to our business;- competition from new products that may emerge;- actual or anticipated fluctuations in our financial condition or operating results;- substantial sales of our common stock;- the market reaction to the Reverse Stock Split;- issuance of new or updated research reports from securities analysts;- announcement or expectation of additional debt or equity financing efforts;- additions or departures of key personnel;- general stock market conditions;- attacks by short sellers or substantial short interest in our common stock; or - other economic or external factors. You may be unable to sell your stock at or above your purchase price.

  • Share Price & Shareholder Rights - Risk 7
    A substantial number of shares may be sold in the market, which may depress the market price for our common stock.

    Sales of a significant number of shares of our common stock, or the expectation that such sales may occur, could significantly reduce the market price of our common stock. These sales, or the possibility that these sales may occur, also might make it more difficult for us to sell equity securities in the future at a time and at a price that we deem appropriate. We have also registered the offer and sale of all shares of common stock that we may issue under our equity compensation plans, including upon the exercise of stock options, shares of common stock we may issue under our current common stock purchase agreement with Lincoln Park, including 302,500 shares of common stock that we have issued under our current common stock purchase agreement with Lincoln Park through the date of this report. These shares can be freely sold in the public market upon issuance. Additionally, sales of our common stock by our executive officers or directors, even when done during an open trading window under our policies with respect to insider sales, may adversely impact the trading price of our common stock. Although we do not expect that the relatively small volume of such sales will itself significantly impact the trading price of our common stock, the market could react negatively to the announcement of such sales, which could in turn affect the trading price of our common stock.

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.