Phio Pharmaceuticals (PHIO) risk factors, FY2025 10-K

Phio Pharmaceuticals's FY2025 10-K, filed Mar 05, 2026, lists 27 risk factors in 4 groups. Against the prior year's 27: 5 new, 5 dropped, 10 substantially reworded.

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Risk factors listed
274 groups
New this year
5vs 27 last year
Dropped
5since the prior 10-K
Substantially reworded
10of those kept
Section length
7k wordsItem 1A

What the changes say

  • Phio Pharmaceuticals emphasizes risks regarding capital requirements, Nasdaq minimum bid compliance, and third-party manufacturing dependencies for its drug candidates.

What changed since the prior 10-K

New

  • NewRisks Relating to Our Financial Condition

    To acquire new technologies, licenses or products

    We depend on external funding from debt, equity, or strategic opportunities to maintain our discovery and development operations.

  • NewRisks Relating to Our Business and Industry

    Adverse results obtained by other companies developing similar drugs

    Adverse preclinical or clinical results from other companies developing similar drugs could delay or prevent our own trials.

  • NewRisks Relating to Our Business and Industry

    Our business and operations would suffer in the event of a cybersecurity incident

    Our IT systems are vulnerable to cyberattacks, phishing, and ransomware that could disrupt our operations.

  • NewRisks Relating to Our Securities

    General economic, industry and market conditions

    Stock market volatility and limited trading volume could depress our stock price or lead to Nasdaq delisting if we fail to maintain $1.00.

  • NewRisks Relating to Our Securities

    Establish advance notice requirements for nominations for election to our Board or for proposing matters that can be acted upon by stockholders at stockholder meetings

    Advance notice requirements and Delaware Section 203 anti-takeover provisions may deter potential business combinations or management changes.

Dropped

  • DroppedRisks Relating to Our Business and Industry

    Changes in U.S. and international trade policies may adversely impact our business and operating results

  • DroppedRisks Relating to Our Business and Industry

    Unstable market and economic conditions, including elevated and sustained inflation, may have serious adverse consequences on our business, financial condition and stock price

  • DroppedRisks Relating to Our Business and Industry

    Our business and operations would suffer in the event of computer system failures, cyberattacks or a deficiency in our cybersecurity

  • DroppedRisks Relating to Our Financial Condition

    We expect to continue to incur significant research and development expenses, which may make it difficult for us to attain profitability, and may lead to uncertainty as to our ability to continue as a going concern

  • DroppedRisks Relating to Our Securities

    We may acquire other businesses or form joint ventures that may be unsuccessful and could dilute your ownership interest in the Company

Reworded

  • 66% rewrittenRisks Relating to Our Securities

    Provisions of our certificate of incorporation and bylaws and Delaware law might discourage, delay or prevent a change of control of the Company or changes in our management and, as a result, depress the trading price of our Common Stock

    Removed mention of blank check preferred stock details from the description of takeover deterrents.

  • 53% rewrittenRisks Relating to Our Securities

    The price of our Common Stock has been and may continue to be volatile

    Updated stock volatility risk to reference the acquisition of new technologies instead of general corporate activities.

  • 49% rewrittenRisks Relating to Our Financial Condition

    We will require substantial additional funds to complete our research and development activities

    Streamlined fundraising activities and removed bullet points regarding patent and employee retention expenses.

  • 47% rewrittenRisks Relating to Our Securities

    We may not be able to maintain compliance with the continued listing requirements of The Nasdaq Capital Market

    Shifted focus from maintaining $2.5 million in stockholders' equity to meeting the $1.00 minimum bid price requirement, citing a July 5, 2024 reverse stock split.

  • 32% rewrittenRisks Relating to Our Business and Industry

    We rely upon third-parties to conduct our clinical trials and other studies for our product candidates, and if they do not successfully fulfill their obligations, the development of our product candidates may be materially impacted

    Changed references from preclinical studies to non-clinical studies regarding third-party CRO reliance.

  • 28% rewrittenRisks Relating to Our Business and Industry

    We rely upon third parties for the manufacture of the clinical supply for our product candidates

    Updated manufacturing risk to state we have 'no' instead of 'limited' in-house manufacturing capabilities and added that we contract with multiple oligonucleotide manufacturers.

  • 25% rewrittenRisks Relating to Our Financial Condition

    We have a history of net losses, and we expect to continue to incur net losses for the foreseeable future and may not achieve or maintain profitability

    Removed references to biologic candidates, retaining only drug candidates.

  • 25% rewrittenRisks Relating to Our Business and Industry

    A number of different factors could prevent us from advancing into clinical development, obtaining regulatory approval, and ultimately commercializing our product candidates on a timely basis, or at all

    Removed references to biologic candidates prior to FDA regulatory approvals.

  • 24% rewrittenRisks Relating to Our Business and Industry

    If we experience delays or difficulties in identifying and enrolling patients in clinical trials, it may lead to delays in generating clinical data and the receipt of necessary regulatory approvals

  • 21% rewrittenRisks Relating to Our Business and Industry

    We are subject to potential liabilities from clinical testing and future product liability claims

All 27 risk factors

Headings as the filing states them, in filing order.

Risks Relating to Our Financial Condition

  1. 01We will require substantial additional funds to complete our research and development activities49% rewritten
  2. 02To acquire new technologies, licenses or productsNew
  3. 03We have a history of net losses, and we expect to continue to incur net losses for the foreseeable future and may not achieve or maintain profitability25% rewritten
  4. 04Future financing may be obtained through, and future development efforts may be paid for by, the issuance of debt or equity, which may have an adverse effect on our stockholders or may otherwise adversely affect our business
  5. 05Our ability to use net operating loss carryforwards and other tax benefits may be limited

Risks Relating to Our Business and Industry

  1. 06We are dependent on the success of our INTASYL technology, and our product candidates based on this platform, which is unproven and may never lead to approved and marketable products
  2. 07Our product candidates are in an early stage of development and we may fail, experience significant delays, never advance clinical development or not be successful in our efforts to identify or discover additional product candidates, which may materially and adversely impact our business
  3. 08If we experience delays or difficulties in identifying and enrolling patients in clinical trials, it may lead to delays in generating clinical data and the receipt of necessary regulatory approvals24% rewritten
  4. 09Topline data may not accurately reflect or may materially differ from the complete results of a clinical trial
  5. 10We rely upon third-parties to conduct our clinical trials and other studies for our product candidates, and if they do not successfully fulfill their obligations, the development of our product candidates may be materially impacted32% rewritten
  6. 11A number of different factors could prevent us from advancing into clinical development, obtaining regulatory approval, and ultimately commercializing our product candidates on a timely basis, or at all25% rewritten
  7. 12Adverse results obtained by other companies developing similar drugsNew
  8. 13Disruptions at the FDA, including due to a reduction in the FDA’s workforce and/or inadequate funding for the FDA, could prevent the FDA from performing normal functions on which our business relies, which could negatively impact our business
  9. 14We are subject to significant competition and may not be able to compete successfully
  10. 15If we fail to attract, hire and retain qualified personnel, we may not be able to design, develop, market or sell our products or successfully manage our business
  11. 16We are subject to potential liabilities from clinical testing and future product liability claims21% rewritten
  12. 17We rely upon third parties for the manufacture of the clinical supply for our product candidates28% rewritten
  13. 18Our business and operations would suffer in the event of a cybersecurity incidentNew

Risks Relating to Our Intellectual Property

  1. 19We may be involved in litigation to protect our patents and intellectual property rights and our ability to protect our patents and intellectual property rights is uncertain and may subject us to potential liabilities
  2. 20Third parties may claim that we infringe their patents, which may result in substantial liabilities and prevent us from pursuing the development of our product candidates
  3. 21We are dependent on the patents we own and the technologies we license, and if we fail to maintain our patents or lose the right to license such technologies, our ability to develop new products would be harmed

Risks Relating to Our Securities

  1. 22The price of our Common Stock has been and may continue to be volatile53% rewritten
  2. 23General economic, industry and market conditionsNew
  3. 24We may not be able to maintain compliance with the continued listing requirements of The Nasdaq Capital Market47% rewritten
  4. 25Our Board of Directors has the authority to issue shares of “blank check” preferred stock and the terms of the preferred stock may reduce the value of our Common Stock
  5. 26Provisions of our certificate of incorporation and bylaws and Delaware law might discourage, delay or prevent a change of control of the Company or changes in our management and, as a result, depress the trading price of our Common Stock66% rewritten
  6. 27Establish advance notice requirements for nominations for election to our Board or for proposing matters that can be acted upon by stockholders at stockholder meetingsNew

Other Phio Pharmaceuticals 10-Ks

  • FY2024 10-K risk factors
    27 risks

    Phio is entirely dependent on its unproven INTASYL technology platform and early-stage product candidates for future revenue. The company faces ongoing financial losses, needs substantial additional capital, and risks Nasdaq delisting if equity falls below $2.5 million. Reliance on third parties for clinical trials, manufacturing, and intellectual property protection creates severe operational vulnerabilities.

    Filed Mar 31, 2025

About this page

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