OS Therapies (OSTX) risk factors, FY2025 10-K

OS Therapies's FY2025 10-K, filed Mar 31, 2026, lists 52 risk factors in 7 groups. Against the prior year's 49: 11 new, 8 dropped, 13 substantially reworded.

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Risk factors listed
527 groups
New this year
11vs 49 last year
Dropped
8since the prior 10-K
Substantially reworded
13of those kept
Section length
27k wordsItem 1A

What the changes say

  • OSTX focuses on clinical development of OST-HER2 for rare Osteosarcoma, facing patient enrollment hurdles and capital constraints.

What changed since the prior 10-K

New

  • NewRisks Related to Drug Development and Regulatory Approval

    Delays or difficulties in enrolling patients in clinical trials could prevent or delay regulatory approval and increase development costs

    Locating enough eligible Osteosarcoma patients for clinical trials is difficult due to a small US incident rate of 1,000 per year.

  • NewRisks Related to Drug Development and Regulatory Approval

    Regulatory authorities may also revise orphan drug regulations or policies, and it is uncertain how any such changes could impact our business or exclusivity rights

    The Rare Pediatric Disease Priority Review Voucher Program is currently authorized through September 30, 2029 under the Consolidated Appropriations Act, 2026.

  • NewRisks Related to Drug Development and Regulatory Approval

    Although a larger number of Osteosarcoma patients reside outside the United States, our ability to generate meaningful revenues in those jurisdictions may be limited due to pricing controls, reimbursement limitations, and other market access challenges

    International revenues for Osteosarcoma treatments may be limited by pricing controls and reimbursement barriers in the European Union and other markets.

  • NewRisks Related to Commercialization

    Our relationships with prescribers, customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to significant penalties and adversely affect our business

    Commercializing product candidates will subject us to federal, state, and foreign anti-kickback and healthcare fraud and abuse laws.

  • NewRisks Related to Employee Matters, Managing Growth and Other Risks Related to Our Business

    Use of artificial intelligence, machine learning and algorithmic tools involves risks that could materially and adversely affect our business, results of operations and development timelines

    Using artificial intelligence and machine learning in clinical trial design or manufacturing planning introduces data security and regulatory compliance risks.

  • NewRisks Related to Employee Matters, Managing Growth and Other Risks Related to Our Business

    Geopolitical events, trade restrictions, sanctions and export controls could adversely affect our clinical operations, supply chain, data flows and financial transactions

    Geopolitical conflicts and export controls could disrupt our supply chain, clinical operations, and data transfers.

  • NewRisks Related to Our Common Stock

    A significant number of additional shares of our common stock may be issued pursuant to outstanding preferred stock, warrants, stock options and convertible securities, which issuances could substantially dilute existing stockholders and may depress the market price of our common stock

    Outstanding preferred stock, warrants, and convertible securities could issue a significant number of additional common shares and dilute existing stockholders.

  • NewRisks Related to Our Common Stock

    We have issued, and may issue in the future, a significant number of shares of our common stock upon the conversion or exercise of outstanding preferred stock, warrants, stock options and other convertible securities

    PIPE financing Series A Preferred Stock and recent warrant exercise inducement transactions could dilute existing common stockholders.

  • NewRisks Related to Our Common Stock

    Sales of a substantial number of shares of our common stock, including those issued pursuant to the Sales Agreement, could cause the market price of our common stock to decline

    Sales of up to $17,469,838 of our common stock under our Sales Agreement could flood the market and depress our stock price.

  • NewRisks Related to Our Common Stock

    It is not possible to predict the aggregate proceeds resulting from sales made under the Sales Agreement

    The aggregate proceeds from sales under our Sales Agreement cannot be predicted due to fluctuating market prices and our discretion.

  • NewRisks Related to Our Common Stock

    The common stock offered pursuant to the Sales Agreement will be sold in “at the market offerings,” and investors who buy shares at different times will likely pay different prices

    Investors buying shares at different times under our Sales Agreement will pay different prices and experience varying dilution.

Dropped

  • DroppedRisks Related to Our Financial Position and Need for Additional Capital

    At two closings occurring on December 31, 2024 and January 14, 2025, we issued an aggregate of (i) 1,775,750 shares of Series A Preferred Stock and (ii) Series A Warrants initially exercisable into 1,775,750 shares of common stock pursuant to the Private Placement

  • DroppedRisks Related to Our Financial Position and Need for Additional Capital

    In consideration of our purchase of the HER2 Assets, we agreed to pay to Ayala $7.5 million shares of our common stock, based on the volume-weighted average price of our common stock over the 30 trading days immediately preceding the closing date of the HER2 Purchase Agreement

  • DroppedRisks Related to Drug Development and Regulatory Approval

    If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented

    Private Placement details for Series A Preferred Stock and Warrants.

  • DroppedRisks Related to Drug Development and Regulatory Approval

    Rare Osteosarcoma has relatively low prevalence and it may be difficult to identify patients with driver genes of the disease, which may lead to delays in enrollment for our trials

    Consideration of 7.5 million shares paid to Ayala for HER2 Assets.

  • DroppedRisks Related to Drug Development and Regulatory Approval

    Although we have obtained rare pediatric disease designation for OST-HER2 for Osteosarcoma patients, we may not be eligible to receive a priority review voucher in the event that FDA approval does not occur prior to September 30, 2026

  • DroppedRisks Related to Our Common Stock

    The issuance of shares in connection with the Private Placement and the HER2 Purchase Agreement could adversely affect the prevailing market price of our shares

  • DroppedRisks Related to Our Common Stock

    It is not possible to predict the actual number of ELOC Shares, if any, we will sell under the ELOC Purchase Agreement to Square Gate, or the actual gross proceeds resulting from those sales

  • DroppedRisks Related to Our Common Stock

    Investors who buy ELOC Shares from Square Gate at different times will likely pay different prices

Reworded

  • 99% rewrittenRisks Related to Our Financial Position and Need for Additional Capital

    If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, scale back or discontinue some of our product candidate development programs or commercialization efforts

    Updated to reflect broader capital needs for BLA submissions, confirmatory trials, and commercialization of OST-HER2, plus preclinical work for OST-tADC.

  • 98% rewrittenRisks Related to Commercialization

    We may face potential liability and increased regulatory scrutiny if we obtain, use or fail to adequately protect identifiable patient health information in connection with our clinical trials and operations

    Clarified that obtaining sensitive patient health information could subject us to HIPAA business associate obligations and criminal liability for misuse.

    Was: We may face potential liability if we obtain identifiable patient health information from clinical trials sponsored by us

  • 97% rewrittenRisks Related to Our Financial Position and Need for Additional Capital

    We are a clinical stage biopharmaceutical company and have not generated any revenue to date from drug sales, and may never become profitable

    Refined language on revenue generation and commercialization status for OST-HER2 and OST-tADC.

  • 94% rewrittenRisks Related to Our Financial Position and Need for Additional Capital

    We have incurred significant operating losses in recent periods and anticipate that we will incur continued losses for the foreseeable future

    Updated aggregate gross proceeds raised since July 2018 to $41.1 million and referenced operating losses for 2024 and 2025.

  • 93% rewrittenRisks Related to Drug Development and Regulatory Approval

    We depend heavily on the success of our lead product candidates, OST-HER2 and OST-tADC. We may not be able to obtain regulatory approval for, or successfully commercialize, any of our current or future product candidates

    Streamlined dependency description on lead product candidates OST-HER2 and OST-tADC for Osteosarcoma.

  • 87% rewrittenRisks Related to Our Financial Position and Need for Additional Capital

    Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern

    Updated going concern disclosure to reference past operating losses, negative cash flows, and continued reliance on equity and debt financing.

  • 74% rewrittenRisks Related to Commercialization

    Even if we are able to commercialize any current or future product candidates, such drugs may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which would harm our business

    Added specific mention of the European Union regarding continued governmental price controls after initial drug approval.

  • 71% rewrittenRisks Related to Commercialization

    Healthcare reform measures may have a material adverse effect on our business and results of operations

    Expanded healthcare reform risks to explicitly include additional recordkeeping, reporting, and compliance obligations.

  • 71% rewrittenRisks Related to Drug Development and Regulatory Approval

    We may not be able to obtain or maintain orphan drug designation or exclusivity for any product candidates and, even if we do, that exclusivity may not prevent the FDA, EMA or other regulatory authorities from approving other competing products

    Was: We may not be able to obtain or maintain orphan drug designation or exclusivity for any product candidates and, even if we do, that exclusivity may not prevent the FDA or EMA from approving other competing products

  • 63% rewrittenRisks Related to Commercialization

    If 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

  • 53% rewrittenRisks Related to Our Dependence on Third Parties

    The third parties upon whom we rely for the supply of the active pharmaceutical ingredient, or API, drug product and drug substance used in our core product candidates are limited in number, and the loss of any of these suppliers could significantly harm our business

  • 53% rewrittenRisks Related to Commercialization

    We face substantial competition, which may result in others discovering, developing or commercializing drugs before or more successfully than we do

  • 32% rewrittenRisks Related to Drug Development and Regulatory Approval

    We may in the future conduct clinical trials for current or future product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials

All 52 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Financial Position and Need for Additional Capital

  1. 01We are a clinical stage biopharmaceutical company and have not generated any revenue to date from drug sales, and may never become profitable97% rewritten
  2. 02We have incurred significant operating losses in recent periods and anticipate that we will incur continued losses for the foreseeable future94% rewritten
  3. 03If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, scale back or discontinue some of our product candidate development programs or commercialization efforts99% rewritten
  4. 04Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates
  5. 05Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern87% rewritten
  6. 06Our ability to utilize our net operating loss carryforwards and certain other tax attributes in the future may be limited

Risks Related to Drug Development and Regulatory Approval

  1. 07We depend heavily on the success of our lead product candidates, OST-HER2 and OST-tADC. We may not be able to obtain regulatory approval for, or successfully commercialize, any of our current or future product candidates93% rewritten
  2. 08Delays or difficulties in enrolling patients in clinical trials could prevent or delay regulatory approval and increase development costsNew
  3. 09Our current or future product candidates may cause adverse or other undesirable side effects that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any
  4. 10A breakthrough therapy designation by the FDA for our current or future product candidate does not convey any advantage in, or shorten the duration of, the regulatory review or approval process, and it does not increase the likelihood that our current or future product candidates will receive marketing approval
  5. 11A fast track designation by the FDA does not convey any advantage in, or shorten the duration of, the regulatory review regulatory review or approval process
  6. 12We may not be able to obtain or maintain orphan drug designation or exclusivity for any product candidates and, even if we do, that exclusivity may not prevent the FDA, EMA or other regulatory authorities from approving other competing products71% rewritten
  7. 13Regulatory authorities may also revise orphan drug regulations or policies, and it is uncertain how any such changes could impact our business or exclusivity rightsNew
  8. 14Manufacturing our current or future product candidates is complex and we may encounter difficulties in production. If we encounter such difficulties, our ability to provide our current or future product candidates for preclinical studies and clinical trials or for commercial purposes could be delayed or stopped
  9. 15Our future growth may depend, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties that could materially adversely affect our business
  10. 16We may in the future conduct clinical trials for current or future product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials32% rewritten
  11. 17Although a larger number of Osteosarcoma patients reside outside the United States, our ability to generate meaningful revenues in those jurisdictions may be limited due to pricing controls, reimbursement limitations, and other market access challengesNew

Risks Related to Commercialization

  1. 18Even if we receive marketing approval for our current or future product candidates, our current or future product candidates may not achieve broad market acceptance, which would limit the revenue that we generate from their sales
  2. 19We face substantial competition, which may result in others discovering, developing or commercializing drugs before or more successfully than we do53% rewritten
  3. 20Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any current or future product candidates that we may develop
  4. 21Even if we are able to commercialize any current or future product candidates, such drugs may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which would harm our business74% rewritten
  5. 22Healthcare reform measures may have a material adverse effect on our business and results of operations71% rewritten
  6. 23Our relationships with prescribers, customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to significant penalties and adversely affect our businessNew
  7. 24We may face potential liability and increased regulatory scrutiny if we obtain, use or fail to adequately protect identifiable patient health information in connection with our clinical trials and operations98% rewritten
  8. 25If 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 business63% rewritten

Risks Related to Our Dependence on Third Parties

  1. 26The third parties upon whom we rely for the supply of the active pharmaceutical ingredient, or API, drug product and drug substance used in our core product candidates are limited in number, and the loss of any of these suppliers could significantly harm our business53% rewritten
  2. 27Our manufacturing process needs to comply with FDA regulations relating to the quality and reliability of such processes. Any failure to comply with relevant regulations could result in delays in or termination of our clinical programs and suspension or withdrawal of any regulatory approvals
  3. 28If our third-party manufacturers use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages

Risks Related to Intellectual Property

  1. 29If we are unable to adequately protect and enforce our trade secrets, our business and competitive position would be harmed
  2. 30We may initiate, become a defendant in, or otherwise become party to lawsuits to protect or enforce our intellectual property rights, which could be expensive, time-consuming and unsuccessful
  3. 31Intellectual property litigation and administrative patent office patent validity challenges in one or more countries could cause us to spend substantial resources and distract our personnel from their normal responsibilities
  4. 32We may not obtain or grant licenses or sublicenses to intellectual property rights in all markets on equally or sufficiently favorable terms with third parties
  5. 33If we fail to comply with our obligations in any agreements under which we may license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business
  6. 34Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our current or future product candidates
  7. 35Intellectual property rights do not guarantee commercial success of current or future product candidates or other business activities. Numerous factors may limit any potential competitive advantage provided by our intellectual property rights

Risks Related to Employee Matters, Managing Growth and Other Risks Related to Our Business

  1. 36Our current operations are located in Maryland; and we or the third parties upon whom we depend may be adversely affected by natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster
  2. 37Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel
  3. 38We will need to develop and expand our company, and we may encounter difficulties in managing this development and expansion, which could disrupt our operations
  4. 39Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price
  5. 40Our internal computer systems, or those of our third-party CROs or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our current or future product candidates’ development programs
  6. 41We may be unable to adequately protect our information systems from cyberattacks, which could result in the disclosure of confidential or proprietary information, including personal data, damage our reputation, and subject us to significant financial and legal exposure
  7. 42Our employees, principal investigators, CROs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading
  8. 43Use of artificial intelligence, machine learning and algorithmic tools involves risks that could materially and adversely affect our business, results of operations and development timelinesNew
  9. 44Geopolitical events, trade restrictions, sanctions and export controls could adversely affect our clinical operations, supply chain, data flows and financial transactionsNew

Risks Related to Our Common Stock

  1. 45A significant number of additional shares of our common stock may be issued pursuant to outstanding preferred stock, warrants, stock options and convertible securities, which issuances could substantially dilute existing stockholders and may depress the market price of our common stockNew
  2. 46We have issued, and may issue in the future, a significant number of shares of our common stock upon the conversion or exercise of outstanding preferred stock, warrants, stock options and other convertible securitiesNew
  3. 47Sales of a substantial number of shares of our common stock, including those issued pursuant to the Sales Agreement, could cause the market price of our common stock to declineNew
  4. 48It is not possible to predict the aggregate proceeds resulting from sales made under the Sales AgreementNew
  5. 49The common stock offered pursuant to the Sales Agreement will be sold in “at the market offerings,” and investors who buy shares at different times will likely pay different pricesNew
  6. 50Paul A. Romness, MPH, and our other executive officers, directors and their affiliates exercise significant influence over our company, which will limit your ability to influence corporate matters and could delay or prevent a change in corporate control
  7. 51We are incurring increased costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives
  8. 52We have not paid, and do not intend to pay, dividends on our shares of common stock and, therefore, unless our common stock appreciates in value, our investors may not benefit from holding our shares

Other OS Therapies 10-Ks

  • FY2024 10-K risk factors
    49 risks

    OSTX focuses entirely on developing immunotherapy candidates OST-HER2 and OST-tADC, facing going-concern doubts, zero revenues, and heavy reliance on key executives Paul A. Romness and Robert G. Petit with only four full-time employees.

    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.