VERU (VERU) FY2025 10-K Risk Factors: 12 New, 18 Dropped

What the changes say

Veru sold its FC2 business and now relies entirely on unapproved drug candidates like enobosarm and sabizabulin.
The company faces litigation from the FC2 buyer, Nasdaq delisting risks, and severe revenue deficits.
Extensive ongoing R&D expenses require continuous external financing amid volatile market conditions.

What changed since the prior 10-K

New

NewRisks Related to the Regulation and Commercialization of Our Products and Drug Candidates
We could experience delays or unanticipated costs in connection with our planned clinical development program of sabizabulin as a treatment to slow the progression of or promote regression of cardiovascular atherosclerotic disease if the FDA does not accept our trial design
Sabizabulin development for cardiovascular atherosclerotic disease could face delays or cost overruns if the FDA rejects the trial design.
NewRisks Related to Ownership of Our Common Stock
Our common stock price may be subject to delisting from Nasdaq if our common stock has a closing bid price of less than $1.00 per share
The APP Acquisition caused past earnings charges and future charges could harm operating results while risking Nasdaq delisting.
NewRisks Related to the Regulation and Commercialization of Our Products and Drug Candidates
We currently have no commercial revenue and may never generate revenue or become profitable
Following the FC2 Business Sale on December 30, 2024, we have no commercial revenue and face continuing operating losses.
NewRisks Related to the Regulation and Commercialization of Our Products and Drug Candidates
set a commercially viable price and obtain reasonable price increases over time for any products for which we may receive approval
We may struggle to set viable prices or obtain reasonable price increases for any future approved products.
NewRisks Related to the Regulation and Commercialization of Our Products and Drug Candidates
Before we can obtain regulatory approval for the commercial sale of our drug candidates, we may be required to complete preclinical development with respect to such drug candidates and/or extensive clinical trials in humans to demonstrate the safety and efficacy of the drug candidates
Preclinical development and human clinical trials may yield unfavorable or misinterpreted results, causing delays or termination.
NewRisks Related to the Regulation and Commercialization of Our Products and Drug Candidates
We are subject to extensive and costly governmental regulation
We are subject to extensive governmental regulation by the FDA, FTC, CMS, Department of Justice, and other bodies.
NewRisks Related to the Regulation and Commercialization of Our Products and Drug Candidates
Our business could be negatively impacted by disruptions at the FDA or other government agencies
Government shutdowns and FDA disruptions, such as furloughs between October and November 2025, can delay drug approvals.
NewRisks Related to Our Financial Position and Need for Capital
Unstable market and economic conditions may have serious adverse consequences on our ability to raise funds, which may cause us to delay, restructure or cease our operations
Global conflicts, pandemics, and U.S. tariffs create economic volatility that impairs our ability to raise capital.
NewRisks Related to Our Business
We are subject to outstanding litigation filed by the purchaser of the FC2 Business, which could result in substantial legal fees or damages and may divert management’s time and attention from our business
The FC2 business purchaser filed a lawsuit in Delaware alleging breach of representations, warranties, and fraud.
NewRisks Related to Ownership of Our Common Stock
Our common stock may be subject to delisting from the Nasdaq Capital Market if our common stock has a closing bid price of less than $1.00 per share
Our common stock fell below $1.00 per share, triggering Nasdaq non-compliance notices and forcing a Reverse Stock Split.
NewRisks Related to Ownership of Our Common Stock
other economic or external factors
Broad market volatility and low trading volume can cause our stock price to decline rapidly.
NewRisks Related to Ownership of Our Common Stock
We may not receive any meaningful amount of, or potentially any, additional funds upon the exercise of our outstanding warrants
We have 7 million pre-funded warrants exercisable at $0.001 per share that provide no meaningful funds and dilute shareholders.

Dropped

DroppedRisks Related to Ownership of Our Common Stock
We have received a notice of delisting from Nasdaq
DroppedRisks Related to the Regulation and Commercialization of Our Products and Drug Candidates
We could experience delays or unanticipated costs in connection with our Phase 2b clinical trial of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA
DroppedRisks Related to the Regulation and Commercialization of Our Products and Drug Candidates
Disruptions to or significantly increased costs associated with transportation and other distribution channels for our products may adversely affect our margins and profitability
DroppedRisks Related to the Regulation and Commercialization of Our Products and Drug Candidates
We are subject to extensive and costly governmental regulation, including healthcare reform measures that may negatively impact sales of FC2
DroppedRisks Related to the Regulation and Commercialization of Our Products and Drug Candidates
Any of these actions could have a material adverse effect on our business
DroppedRisks Related to Our Financial Position and Need for Capital
These factors could result in variations from currently projected operating and liquidity requirements
DroppedRisks Related to Our Financial Position and Need for Capital
We may not receive any additional payments from ONCO in connection with the sale of our ENTADFI assets and may not receive any value for the shares of ONCO common stock that we might hold from time to time
DroppedRisks Related to Our Business
Our FC2 business may be affected by contracting risks with government and other international health agencies
DroppedRisks Related to Our Business
The 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
DroppedRisks Related to Our Business
Our net revenues from sales of FC2 may not return to past levels
DroppedRisks Related to Our Business
We may not be able to successfully implement our strategy to grow sales of FC2 in the U.S. market through our own telehealth portal
DroppedRisks Related to Our Business
Since we sell FC2 in foreign markets, we are subject to international business risks that could adversely affect our operating results
Received a notice of delisting from Nasdaq.
DroppedRisks Related to Our Business
difficulties in our ability to enforce legal rights and remedies
DroppedRisks Related to Our Business
Increases in the cost of raw materials, labor, and other costs used to manufacture FC2 could increase our cost of sales and reduce our gross margins
DroppedRisks Related to Our Business
Currency exchange rate fluctuations could increase our expenses
DroppedRisks Related to Our Business
We rely on a single facility to manufacture FC2, and single source suppliers for certain raw materials, which subjects us to the risk of supply disruptions
DroppedRisks Related to Our Business
We may incur costs or experience supply interruptions relating to our need to transition the supply of the nitrile polymer for FC2
DroppedRisks Related to Our Business
Any failure to comply with the FCPA and similar anti-bribery laws in non-U.S. jurisdiction could materially adversely affect our business and result in civil and/or criminal sanctions
Delays or costs in enobosarm Phase 2b trial for sarcopenic obesity with GLP-1 RA.

Reworded

100% rewrittenRisks Related to the Regulation and Commercialization of Our Products and Drug Candidates
Our clinical trials may be suspended or discontinued
Added specific focus on enobosarm for obese or overweight elderly patients receiving a GLP-1 RA.
100% rewrittenRisks Related to Our Financial Position and Need for Capital
We have incurred net losses in recent fiscal years and expect to continue to incur losses for the foreseeable future
Removed specific net loss figures from the prior fiscal year.
100% rewrittenRisks Related to Our Business
Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited
Replaced net operating loss carryforward figures and tax disclosures with the new FC2 purchaser litigation risk.
100% rewrittenRisks Relating to Our Intellectual Property
We may be unable to protect the proprietary nature of the intellectual property covering our products
Removed intellectual property protection and patent uncertainty disclosures.
100% rewrittenRisks Related to the Regulation and Commercialization of Our Products and Drug Candidates
We could experience delays or unanticipated costs in connection with our planned clinical development program of enobosarm as a treatment to augment fat loss and to prevent muscle loss in obese or overweight older patients receiving a GLP-1 RA
Updated enobosarm clinical trial status to reflect completed Phase 2b topline results and extension study data.
Was: We could experience delays or unanticipated costs in connection with our planned clinical development program of enobosarm as a treatment to augment fat loss and to prevent lean mass (muscle) loss in sarcopenic obese or overweight patients receiving a GLP-1 RA
100% rewrittenRisks Related to Our Financial Position and Need for Capital
We have incurred net losses in recent fiscal years and expect to continue to incur losses for the foreseeable future
Added exact net loss figures of $22.7 million for fiscal 2025 and $37.8 million for fiscal 2024.
Was: We have incurred net losses in recent fiscal years and expect to continue to incur losses for the foreseeable future
100% rewrittenRisks Related to Our Financial Position and Need for Capital
The amount of additional financing that we will need to support our development and commercialization activities is uncertain
Removed SEC Form S-3 and ONCO asset mentions, focusing entirely on future capital requirements for drug candidates.
100% rewrittenRisks Relating to Our Intellectual Property
We may be unable to protect the proprietary nature of the intellectual property covering our products
Restored intellectual property protection and patent uncertainty disclosures previously removed.
Was: We may be unable to protect the proprietary nature of the intellectual property covering our products
78% rewrittenRisks Related to the Regulation and Commercialization of Our Products and Drug Candidates
delays resulting from shutdowns or quarantines or staffing shortages relating to a pandemic or other reasons
74% rewrittenRisks Related to Ownership of Our Common Stock
Ownership in our common stock is highly concentrated and your ability to influence corporate matters may be limited as a result
55% rewrittenRisks Related to Our Business
We may experience competition, especially for enobosarm as a treatment for metabolic diseases, if approved
Was: We may experience competition, especially for enobosarm as a treatment for metabolic diseases, if approved, and FC2
54% rewrittenRisks Related to the Regulation and Commercialization of Our Products and Drug Candidates
Our development and commercialization of sabizabulin as a treatment to slow the progression of or promote regression of cardiovascular atherosclerotic disease will depend on our ability to secure significant funding through pharmaceutical company partnerships or other external sources
Was: Our development and commercialization of sabizabulin as a treatment for ARDS will depend on our ability to secure significant funding through government grants, pharmaceutical company partnerships or similar external sources
54% rewrittenRisks Related to the Regulation and Commercialization of Our Products and Drug Candidates
We may fail or elect not to commercialize our drug candidates or our approved or authorized products
53% rewrittenRisks Related to Our Financial Position and Need for Capital
Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements included in this Annual Report on Form 10-K for the fiscal year ended September 30, 2025
Was: Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements included in this Annual Report on Form 10-K for the fiscal year ended September 30, 2024
49% rewrittenRisks Related to Our Business
It is unlikely that we will collect any amount of our accounts receivable with The Pill Club
43% rewrittenRisks Related to Our Business
Our effective tax rate may be negatively impacted if we are unable to realize deferred tax assets or by future changes to tax laws in jurisdictions in which we operate
37% rewrittenRisks Related to Ownership of Our Common Stock
A substantial number of shares may be sold in the market, which may depress the market price for our common stock
32% rewrittenRisks Related to Our Business
Our business and operations would suffer if we sustain cyber-attacks or other privacy or data security incidents that result in security breaches
31% rewrittenRisks Related to Our Business
We are subject to significant payment obligations pursuant to the resolution of a dispute with a supplier
30% rewrittenRisks Related to Our Business
Uncertainty and adverse changes in the general economic conditions may negatively affect our business
26% rewrittenRisks Related to Ownership of Our Common Stock
The trading price of our common stock has been volatile, and investors in our common stock may experience substantial losses
24% rewrittenRisks Related to Our Business
We will need to increase the size and complexity of our organization in the future, and we may experience difficulties in executing our growth strategy and managing any growth
22% rewrittenRisks Related to Ownership of Our Common Stock
There are provisions in our charter documents and Wisconsin law that might prevent or delay a change in control of our company
Was: There are provisions in our charter documents, Wisconsin law and our residual royalty agreement that might prevent or delay a change in control of our company
20% rewrittenRisks Relating to Our Intellectual Property
Our or our licensors’ patents may expire or be invalidated, found to be unenforceable, narrowed or otherwise limited or our or our licensors’ patent applications may not result in issued patents or may result in patents with narrow, overbroad, or unenforceable claims
20% rewrittenRisks Related to the Regulation and Commercialization of Our Products and Drug Candidates
state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws that may apply to items or services reimbursed by any third-party payor, including commercial insurers

All 71 risk factors

Headings as the filing states them, in filing order.

Risks Related to the Regulation and Commercialization of Our Products and Drug Candidates

01Our clinical trials may be suspended or discontinued100% rewritten
02We could experience delays or unanticipated costs in connection with our planned clinical development program of sabizabulin as a treatment to slow the progression of or promote regression of cardiovascular atherosclerotic disease if the FDA does not accept our trial designNew
03We may fail or elect not to commercialize our drug candidates or our approved or authorized products54% rewritten
15We currently have no commercial revenue and may never generate revenue or become profitableNew
16set a commercially viable price and obtain reasonable price increases over time for any products for which we may receive approvalNew
17We have limited experience in obtaining regulatory approval for a drug
18We could experience delays in our planned clinical trials
19delays resulting from shutdowns or quarantines or staffing shortages relating to a pandemic or other reasons78% rewritten
20Before we can obtain regulatory approval for the commercial sale of our drug candidates, we may be required to complete preclinical development with respect to such drug candidates and/or extensive clinical trials in humans to demonstrate the safety and efficacy of the drug candidatesNew
21We could experience delays or unanticipated costs in connection with our planned clinical development program of enobosarm as a treatment to augment fat loss and to prevent muscle loss in obese or overweight older patients receiving a GLP-1 RA100% rewritten
22Interim, preliminary and topline data from our preclinical studies and clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data
23We may be subject to risks relating to collaboration with third parties
24We rely on CROs to conduct our research and development activities
25We rely on third party manufacturers for our drug candidates
26Changes in law could have a negative impact on the approval of our drug candidates
27Our development and commercialization of sabizabulin as a treatment to slow the progression of or promote regression of cardiovascular atherosclerotic disease will depend on our ability to secure significant funding through pharmaceutical company partnerships or other external sources54% rewritten
28We are subject to extensive and costly governmental regulationNew
29state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws that may apply to items or services reimbursed by any third-party payor, including commercial insurers20% rewritten
30Our business could be negatively impacted by disruptions at the FDA or other government agenciesNew
31We could experience misconduct by our employees
32Coverage and reimbursement may not be available for our products
33We may not be able to gain and retain market acceptance for our drug candidates
34prevalence and severity of adverse side effects
35Our drug products may be subject to governmental pricing controls
36Third parties may obtain FDA regulatory exclusivity to our detriment

Risks Related to Our Financial Position and Need for Capital

04We have incurred net losses in recent fiscal years and expect to continue to incur losses for the foreseeable future100% rewritten
05Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements included in this Annual Report on Form 10-K for the fiscal year ended September 30, 202553% rewritten
37We have incurred net losses in recent fiscal years and expect to continue to incur losses for the foreseeable future100% rewritten
38The amount of additional financing that we will need to support our development and commercialization activities is uncertain100% rewritten
39Unstable market and economic conditions may have serious adverse consequences on our ability to raise funds, which may cause us to delay, restructure or cease our operationsNew

Risks Related to Our Business

06Material adverse or unforeseen legal judgments, fines, penalties, or settlements could have an adverse impact on our profits and cash flows
07We will need to increase the size and complexity of our organization in the future, and we may experience difficulties in executing our growth strategy and managing any growth24% rewritten
08Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited100% rewritten
40We may experience competition, especially for enobosarm as a treatment for metabolic diseases, if approved55% rewritten
41An inability to identify or complete future acquisitions could adversely affect our future growth
42We may experience difficulties in integrating strategic acquisitions
43unanticipated management or operational problems or liabilities may adversely affect our profitability and financial condition
44We may be subject to claims or investigations relating to The Pill Club’s business practices with respect to sales of FC2
45It is unlikely that we will collect any amount of our accounts receivable with The Pill Club49% rewritten
46We are subject to significant payment obligations pursuant to the resolution of a dispute with a supplier31% rewritten
47Uncertainty and adverse changes in the general economic conditions may negatively affect our business30% rewritten
48a decline in the value of our shares
49We 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
50Our business and operations would suffer if we sustain cyber-attacks or other privacy or data security incidents that result in security breaches32% rewritten
51manage our development efforts effectively while carrying out our contractual obligations to partners and other third parties
52Uncertainties in the interpretation and application of tax rules in the various jurisdictions in which we operate could materially affect our deferred tax assets, tax obligations and effective tax rate
53Our effective tax rate may be negatively impacted if we are unable to realize deferred tax assets or by future changes to tax laws in jurisdictions in which we operate43% rewritten
54We are subject to outstanding litigation filed by the purchaser of the FC2 Business, which could result in substantial legal fees or damages and may divert management’s time and attention from our businessNew

Risks Relating to Our Intellectual Property

09We may be unable to protect the proprietary nature of the intellectual property covering our products100% rewritten
10Our or our licensors’ patents may expire or be invalidated, found to be unenforceable, narrowed or otherwise limited or our or our licensors’ patent applications may not result in issued patents or may result in patents with narrow, overbroad, or unenforceable claims20% rewritten
11We are dependent in part on some license relationships
55We may be unable to protect the proprietary nature of the intellectual property covering our products100% rewritten
56inability to control patent prosecution, maintenance, or enforcement of any in-licensed intellectual property
57We may not have sufficient intellectual property protection for enobosarm as a treatment to augment fat loss and to prevent muscle loss in obese or overweight elderly patients receiving GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness
58We 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
59we may need to redesign our products so they do not infringe, which may not be possible or may require substantial monetary expenditures and time
60We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of our competitors
61We may need to file lawsuits or take other actions to protect or enforce our intellectual property rights
62We may fail to protect the confidentiality of commercially sensitive information

Risks Related to Ownership of Our Common Stock

12Our common stock price may be subject to delisting from Nasdaq if our common stock has a closing bid price of less than $1.00 per shareNew
13The restatements of our prior financial statements may affect stockholder and investor confidence in us or harm our reputation, and may subject us to additional risks and uncertainties, including increased costs and the increased possibility of legal proceedings and regulatory inquiries, sanctions or investigations
14Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be our shareholders’ sole source of gain
63Ownership in our common stock is highly concentrated and your ability to influence corporate matters may be limited as a result74% rewritten
64Our common stock may be subject to delisting from the Nasdaq Capital Market if our common stock has a closing bid price of less than $1.00 per shareNew
65a decreased ability to issue additional securities or obtain additional financing in the future
66We 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
67There are provisions in our charter documents and Wisconsin law that might prevent or delay a change in control of our company22% rewritten
68The trading price of our common stock has been volatile, and investors in our common stock may experience substantial losses26% rewritten
69other economic or external factorsNew
70A substantial number of shares may be sold in the market, which may depress the market price for our common stock37% rewritten
71We may not receive any meaningful amount of, or potentially any, additional funds upon the exercise of our outstanding warrantsNew

Other VERU 10-Ks

FY2024 10-K risk factors
77 risks
Veru's risk profile centers heavily on clinical trial execution and funding risks for enobosarm and sabizabulin. The company faces a going concern warning, Nasdaq delisting notice, and SEC Form S-3 ineligibility affecting capital raises.
Filed Dec 16, 2024

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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.