Pelthos Therapeutics (PTHS) FY2025 10-K Risk Factors: 43 New, 50 Dropped

What the changes say

Pelthos Therapeutics launched ZELSUVMI for molluscum contagiosum in July 2025, shifting its risk profile from clinical development to commercialization.
The risk section emphasizes commercial execution, market acceptance, gross-to-net expenses, and ongoing internal control weaknesses.

What changed since the prior 10-K

New

NewRisks Related to Our Financial Condition and Capital Needs
We have a limited operating history and history of commercializing products, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability
We have a limited operating history and early-stage commercialization efforts for ZELSUVMI, making our future viability difficult to evaluate.
NewRisks Related to Commercialization of Our Products and any Future Product Candidates
If we are unable to successfully meet our internal development and manufacturing timelines, including the management of third-parties on which we rely, we may have delays in the expected commercial launch of XEPI and/or XEGLYZE, or we may be unable to commercialize either product at all
Internal development and third-party manufacturing delays could hinder the commercial launch of XEPI and XEGLYZE.
NewRisks Related to Commercialization of Our Products and any Future Product Candidates
ZELSUVMI, our approved products that have not yet been launched and any of our product candidates that receive regulatory approval, may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success
ZELSUVMI and future product candidates may fail to achieve necessary market acceptance from physicians, patients, and third-party payors.
NewRisks Related to Commercialization of Our Products and any Future Product Candidates
The failure of healthcare professionals or patients to perceive the benefits of using ZELSUVMI for the treatment of molluscum contagiosum instead of other alternative therapies, such as curettage, cantharidin application or cryotherapy, would adversely affect the commercial success of ZELSUVMI
Failure of patients and healthcare professionals to choose ZELSUVMI over alternative treatments like curettage or cryotherapy would harm sales.
NewRisks Related to Commercialization of Our Products and any Future Product Candidates
We face substantial competition, which may result in a smaller than expected commercial opportunity and/or other firms may discover, develop or commercialize products before or more successfully than we do
We face substantial competition from major pharmaceutical companies, compounding facilities, and off-label drug uses.
NewRisks Related to Commercialization of Our Products and any Future Product Candidates
In addition, our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than ZELSUVMI or any other product that we may develop
Competitors with greater resources could develop safer, more effective, or less expensive alternatives to ZELSUVMI.
NewRisks Related to Commercialization of Our Products and any Future Product Candidates
Our gross to net (“GTN”) expenses could increase, resulting in a negative impact to our net revenues, causing a reduction in cash flow, potential impact to our stock price and have other deleterious effects to our investors
Higher usage of co-pay cards and distribution fees could increase gross-to-net expenses, reducing net revenues and cash flow.
NewRisks Related to Commercialization of Our Products and any Future Product Candidates
The commercial success of our products and product candidates will depend upon the degree of market acceptance by physicians, patients, third-party payers and others in the medical community
Commercial success depends on the medical community and third-party payers accepting ZELSUVMI as safe and effective.
NewRisks Related to Commercialization of Our Products and any Future Product Candidates
Even if a product candidate displays a favorable efficacy and safety profile in preclinical studies and clinical trials, market acceptance of the product will not be known until after it is launched. Any failure to achieve market acceptance of our products will harm our business, results and financial condition
Healthcare guidelines or recommendations could favor competing treatments over ZELSUVMI.
NewRisks Related to Commercialization of Our Products and any Future Product Candidates
Our products may become subject to unfavorable third-party coverage or reimbursement policies, which would harm our business
Unfavorable third-party coverage, reimbursement policies, or healthcare reform could harm sales.
NewRisks Related to Commercialization of Our Products and any Future Product Candidates
Molluscum contagiosum is a skin disease that is currently undertreated. Even with approval of ZELSUVMI in adult and pediatric patients one year and older, individuals may continue to decline treatment for molluscum contagiosum as, if left untreated, the diseases will eventually be resolved by the body’s immune system
Patients may decline treatment for molluscum contagiosum because the skin disease eventually resolves on its own.
NewRisks Related to Commercialization of Our Products and any Future Product Candidates
The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses
We are strictly prohibited from promoting ZELSUVMI for off-label uses outside of molluscum contagiosum in patients aged one and older.
NewRisks Related to Our Operations and Manufacturing
injunctions, civil penalties, delays, suspension or withdrawal of approvals, seizures or recalls, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect our financial position
NewRisks Related to Our Operations and Manufacturing
Our business involves the use of hazardous materials, and we and our third-party suppliers and manufacturers must comply with environmental laws and regulations, which can be expensive and restrict how we do business
NewRisks Related to Our Operations and Manufacturing
The seasonal nature of our business may cause fluctuations in operations
NewRisks Related to Our Operations and Manufacturing
We may be adversely affected by the effects of inflation or trade tariffs
NewRisks Related to Our Dependence on Third Parties
We will rely on third parties to conduct any preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to obtain regulatory approval for or commercialize any of our future product candidates
NewRisks Related to Our Dependence on Third Parties
any reason, we may not be able to enter into similar arrangements with alternative third parties within a short period of time or do so on commercially reasonable terms
NewRisks Related to Our Dependence on Third Parties
Our employees, independent contractors, principal investigators, CMOs, CROs, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could expose us to liability and hurt our reputation
NewRisks Related to Our Dependence on Third Parties
We sell to a limited number of wholesalers who have significant market share and if we lose our relationship with any one of those wholesalers, our revenue could be impacted and business could materially suffer
NewRisks Related to Intellectual Property
We may ultimately need to modify our activities or technologies to design around such infringement, which may be time- and resource-consuming, and which ultimately may not be successful. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects
NewRisks Related to Intellectual Property
Third party intellectual property may prevent us from developing our potential products; our intellectual property may not prevent competition; and any intellectual property issues may be expensive and time consuming to resolve
NewRisks Related to Intellectual Property
Issued patents directed to the NITRICIL platform and technology could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad
NewRisks Related to Intellectual Property
commercialize our technology and product candidates and, resultantly, on our business, financial condition, prospects and results of operations
NewRisks Related to Intellectual Property
We may be subject to claims challenging the inventorship of the patents and other intellectual property on which we rely
NewRisks Related to Intellectual Property
If we are unable to protect the confidentiality of our information and our trade secrets, the value of our technology could be materially and adversely affected and our business could be harmed
NewRisks Related to Intellectual Property
If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest and our competitive position may be harmed
NewRisks Related to Regulatory and Legal Compliance
Current and future healthcare reform legislation or regulation may increase the difficulty and cost for us to commercialize our products and may adversely affect the prices we may obtain and may have a negative impact on our business and results of operations
NewRisks Related to Regulatory and Legal Compliance
regulations. Unexpected refunds to the government, and responding to a government investigation or enforcement action, would be expensive and time-consuming, and could have a material adverse effect on our business, financial condition, results of operations and growth prospects
NewRisks Related to Regulatory and Legal Compliance
Changes in and actual or perceived failures to comply with applicable data privacy, security and protection laws, regulations, standards and contractual obligations may adversely affect our business, operations and financial performance
NewRisks Related to Regulatory and Legal Compliance
information, necessitate the acceptance of more onerous obligations in our contracts, result in liability, or impose additional costs on us. The cost of compliance with these laws, regulations, and standards is high and likely to increase in the future
NewRisks Related to Regulatory and Legal Compliance
the manner in which we provide our services, the geographical location or segregation of our relevant systems and operations, and could adversely affect our financial results
NewRisks Related to Regulatory and Legal Compliance
If plaintiffs bring product liability lawsuits against us or our partners, we or our partners may incur substantial liabilities and may be required to limit commercialization of our approved products, approved products not yet launched and product candidates
NewRisks Related to Regulatory and Legal Compliance
We face risks related to handling of hazardous materials and other regulations governing environmental safety
NewRisks Related to Regulatory and Legal Compliance
We may also be subject to other laws and regulations not specifically targeting the healthcare industry
NewRisks Related to our Common Stock
business and operating results. Compliance with these rules and regulations increases our legal and financial compliance costs, makes some activities more difficult, time-consuming, or costly, and increases demand on our systems and resources
NewRisks Related to our Common Stock
The occurrence of a catastrophic disaster could disrupt our business, damage our facilities beyond insurance limits, increase our costs and expenses, or we could lose key data which could cause us to curtail or cease operations
NewRisks Related to our Common Stock
Impairment charges pertaining to goodwill, identifiable intangible assets or other long-lived assets from our mergers and acquisitions could have an adverse impact on our results of operations and our market value
NewRisks Related to our Common Stock
Our results of operations and liquidity needs could be materially negatively affected by market fluctuations and economic downturn
NewRisks Related to our Common Stock
Our business is subject to risks arising from pandemic and epidemic diseases
NewRisks Related to our Common Stock
The biopharmaceutical industry may be negatively affected by federal government deficit reduction policies, which could reduce the value of ZELSUVMI
NewRisks Related to our Common Stock
We may pursue strategic transactions, including asset divestitures, sales, spin‑outs or other distributions, which could materially adversely affect our business, financial condition, results of operations and the value of our securities
NewRisks Related to our Common Stock
Our failure to maintain compliance with stock exchange listing requirements could result in our Common Stock being delisted

Dropped

DroppedRisks Related to Our Business
The report of the independent registered public accounting firm on our 2024 and 2023 financial statements contains a going concern qualification
Auditor's going concern qualification regarding recurring operating losses and accumulated deficit.
DroppedRisks Related to Our Business
We are a clinical stage biopharmaceutical company with a limited operating history
Early clinical stage operations and compound development history.
DroppedRisks Related to Our Business
There are numerous risks and uncertainties associated with pharmaceutical product and biological development, and we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability
Historical net losses and accumulated deficit of $21.5 million.
DroppedRisks Related to Our Business
We may be subject to litigation for a variety of claims, which could adversely affect our results of operations, harm our reputation or otherwise negatively impact our business
DroppedRisks Related to Development, Clinical Testing, and Regulatory Approval
We are early in our efforts to develop CT2000 and have not moved into clinical trials. If we are unable to advance CT2000 through clinical trials, obtain regulatory approval and ultimately commercialize CT2000, or if we experience significant delays in doing so, our business will be materially harmed
DroppedRisks Related to Development, Clinical Testing, and Regulatory Approval
We are early in our efforts to develop CT3000 and have not moved into clinical trials. If we are unable to advance CT3000 through clinical trials, obtain regulatory approval and ultimately commercialize CT3000, or if we experience significant delays in doing so, our business will be materially harmed
Potential litigation risks for labor, commercial, and other employment claims.
DroppedRisks Related to Development, Clinical Testing, and Regulatory Approval
We may encounter substantial delays in our pre-clinical and clinical trials, or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities
Uncertainties regarding the early development of CT2000 for eye pain.
DroppedRisks Related to Development, Clinical Testing, and Regulatory Approval
Our drug development costs will increase if we experience delays in testing or obtaining marketing approvals. We do not know whether any of our preclinical studies or clinical trials will begin as planned, need to be restructured or be completed on schedule, if at all
Uncertainties regarding the early development of CT3000 for post-surgical pain.
DroppedRisks Related to Development, Clinical Testing, and Regulatory Approval
Even if we complete the necessary clinical trials, we cannot predict when, or if, we will obtain regulatory approval to commercialize CC8464, CT2000 and CT3000 and the approval may be for a narrower indication than we seek
Pre-clinical and clinical trial delays for CC8464, CT2000, and CT3000.
DroppedRisks Related to Development, Clinical Testing, and Regulatory Approval
CC8464, CT2000 and CT3000 may cause undesirable side effects or have other properties that could delay or prevent its regulatory approval, limit the commercial potential or result in significant negative consequences following any potential marketing approval
Potential suspension of clinical trials by regulatory bodies.
DroppedRisks Related to Development, Clinical Testing, and Regulatory Approval
CC8464, CT2000 and CT3000 are based on specific modes of administration (dose escalation regime, eye drops and injection, respectively), which makes it difficult to predict the time and cost of development and of subsequently obtaining regulatory approval
Regulatory approval timing and narrow indication risks for pipeline compounds.
DroppedRisks Related to Development, Clinical Testing, and Regulatory Approval
Even if we obtain regulatory approval for CC8464, CT2000 and CT3000, our compounds will remain subject to regulatory oversight
Undesirable side effects such as rashes from CC8464.
DroppedRisks Related to Development, Clinical Testing, and Regulatory Approval
Even if we obtain and maintain approval for CC8464, CT2000 and CT3000 from the FDA, we may never obtain approval for them outside of the United States, which would limit our market opportunities and adversely affect our business
Development and regulatory cost unpredictability for novel delivery modes.
DroppedRisks Related to Development, Clinical Testing, and Regulatory Approval
If we are not able to secure an orphan drug designation, or if the exclusivity associated with such designation does not effectively protect us from competition, our business, financial condition, results of operations and prospects will be adversely affected
Ongoing post-market regulatory oversight for approved compounds.
DroppedRisks Related to Development, Clinical Testing, and Regulatory Approval
We may expend our limited resources to pursue a compound or indication and fail to capitalize on our compounds or indications that may be more profitable or for which there is a greater likelihood of success
DroppedRisks Related to Development, Clinical Testing, and Regulatory Approval
If we are not successful in discovering, developing and commercializing additional compounds, our ability to expand our business and achieve our strategic objectives would be impaired
DroppedRisks Related to Development, Clinical Testing, and Regulatory Approval
If we are unsuccessful in identifying and developing additional new compounds, our potential for growth may be impaired
DroppedRisks Related to Development, Clinical Testing, and Regulatory Approval
On December 23, 2023, we entered into the Benuvia License Agreement. We are dependent on the Benuvia License Agreement, and the termination of the Benuvia License Agreement could have an adverse effect on our business
DroppedRisks Related to Development, Clinical Testing, and Regulatory Approval
If Benuvia does not properly maintain or enforce the intellectual property underlying the Benuvia License Agreement, our competitive position and business prospects could be harmed. Benuvia may also seek to terminate our license
DroppedRisks Related to Manufacturing
Delays in obtaining regulatory approvals of the process and facilities needed to manufacture CC8464, CT2000, CT3000 or any of our other compounds or disruptions in our manufacturing process may delay or disrupt our product development and commercialization efforts
DroppedRisks Related to Manufacturing
Given the nature of sterile product manufacturing, there is a risk of contamination. Any contamination could materially adversely affect our ability to produce CC8464, CT2000 and CT3000 on schedule and could, therefore, harm our results of operations and cause reputational damage
DroppedRisks Related to Commercialization of Our Compounds
If we are unable to expand our market development capabilities or enter into agreements with third parties to market and sell our compounds, we may be unable to generate any revenue
DroppedRisks Related to Commercialization of Our Compounds
If the market opportunities for CC8464, CT2000, CT3000 or our future compounds are smaller than we believe they are, our revenues may be adversely impacted, and our business may suffer
DroppedRisks Related to Commercialization of Our Compounds
Government price controls or other changes in pricing regulation could restrict the amount that we are able to charge for CC8464, CT2000 and CT3000, if approved, or any of our other future compounds that may be approved in the future, which would adversely affect our revenue and results of operations
DroppedRisks Related to Commercialization of Our Compounds
The insurance coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for our products, if approved, could limit our ability to market those products and decrease our ability to generate product revenue
DroppedRisks Related to Our Business Operations
We may not be successful in our efforts to identify or discover additional compounds and may fail to capitalize on programs or compounds that may be a greater commercial opportunity or for which there is a greater likelihood of success
DroppedRisks Related to Our Business Operations
If we are unable to manage expected growth in the scale and complexity of our operations, our performance may suffer
DroppedRisks Related to Our Business Operations
Our future success depends on our ability to retain key employees and scientific advisors and to attract, retain and motivate qualified personnel
DroppedRisks Related to Our Business Operations
Our employees, principal investigators and advisors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements
DroppedRisks Related to Our Business Operations
We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties
DroppedRisks Related to Our Business Operations
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
DroppedRisks Related to Our Business Operations
Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations
DroppedRisks Related to Our Intellectual Property
We may not be able to protect our intellectual property or enforce our intellectual property rights adequately throughout the world
DroppedRisks Related to Our Intellectual Property
Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business
DroppedRisks Related to Our Intellectual Property
Third parties may initiate legal or administrative proceedings attacking the validity of our patents protecting CC8464, CT2000, CT3000 and future compounds the outcome of which would be uncertain and could have a material adverse effect on the success of our business
DroppedRisks Related to Our Intellectual Property
Instituting and defending against patent and other types of intellectual property litigation and administrative proceedings could cause us to spend substantial resources, distract our personnel from their normal responsibilities, and have uncertain outcomes
DroppedRisks Related to Our Intellectual Property
Intellectual property rights and regulatory exclusivity rights do not necessarily address all potential threats
DroppedRisks Related to Our Intellectual Property
Should any of these events occur, they could significantly harm our business, financial condition, results of operations and prospects
DroppedRisks Related to our Common Stock
A significant portion of our total outstanding shares are restricted from immediate resale but may be sold into the market in the near future, which could cause the market price of our Common Stock to drop significantly, even if our business is performing well
DroppedRisks Related to our Common Stock
All of the shares of Common Stock in the IPO are immediately tradable without restriction under the Securities Act, except for any securities held by “affiliates,” as that term is defined in Rule 144 under the Securities Act, or Rule 144
DroppedRisks Related to our Common Stock
In addition, we have registered the Selling Stockholder Shares pursuant to the Resale Prospectus and, as a result, all of the Selling Stockholder Shares are freely tradable under the Securities Act, subject to the terms of the lock up agreements
DroppedRisks Related to our Common Stock
Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies, CC8464, CT2000 and CT3000
DroppedRisks Related to our CEF Purchase Agreement
It is not possible to predict the actual number of Purchase Shares we will sell under the CEF Purchase Agreement, or the actual gross proceeds resulting from those sales. We may not have access to the full amount available under the CEF Purchase Agreement with Tikkun
DroppedRisks Related to our CEF Purchase Agreement
On July 26, 2024, we entered into the CEF Purchase Agreement (the “CEF Purchase Agreement”) with Tikkun Capital LLC (“Tikkun”), pursuant to which Tikkun committed to purchase up to $30.0 million in shares of our Common Stock, subject to certain limitations and conditions set forth in the CEF Purchase Agreement
DroppedRisks Related to our CEF Purchase Agreement
Sales of a substantial number of our Common Stock in the public market by our existing stockholders could cause the price of our shares of our Common Stock to fall
DroppedRisks Related to our CEF Purchase Agreement
Investors who buy shares of our Common Stock at different times will likely pay different prices
DroppedRisks Related to our CEF Purchase Agreement
We may require additional financing to sustain our operations and, without it, we will not be able to continue operations
DroppedRisks Related to our CEF Purchase Agreement
The terms of the CEF Purchase Agreement limit the amount of shares of Common Stock we may issue to Tikkun, which may have an adverse effect on our liquidity
DroppedRisks Related to our CEF Purchase Agreement
Future sales of substantial amounts of our Common Stock, or the possibility that such sales could occur, could adversely affect the market price of our Common Stock
DroppedRisks Related to our CEF Purchase Agreement
Management will have broad discretion as to the use of the proceeds from our sale of Purchase Shares to Tikkun under the CEF Purchase Agreement, and such uses may not improve our financial condition or market value

Reworded

97% rewrittenRisks Related to Intellectual Property
Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing Ligand’s ability to protect our products, platform and technology on which we rely
Updated to focus on general U.S. patent law changes and their impact on inventing, maintaining, and enforcing intellectual property.
Was: Changes in United States patent law and its administrative and judicial interpretation could diminish the value of patents in general, thereby impairing our ability to protect our compounds
95% rewrittenRisks Related to our Common Stock
If securities or industry analysts do not publish research or reports about our business, or publish negative reports about our business, or we don’t meet expectations in those research reports, our Common Stock price and trading volume could decline
Expanded analyst coverage risks to explicitly reference the company's market and competitors.
Was: If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our stock, the price of our stock could decline
87% rewrittenRisks Related to our Common Stock
We have previously identified material weaknesses in our internal control over financial reporting
Narrowed material weaknesses in internal controls to specifically reference the audit of the year ended December 31, 2024.
Was: We have identified material weaknesses in our internal control over financial reporting
87% rewrittenRisks Related to Commercialization of Our Products and any Future Product Candidates
Product liability lawsuits could cause us to incur substantial liabilities and limit commercialization of any products that we may develop
Shifted product liability risk from clinical trial candidates to include commercial sales of ZELSUVMI and specific consequences like media attention and withdrawal of participants.
Was: Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop
72% rewrittenRisks Related to our Common Stock
The requirements of being a public company may strain our resources and divert management’s attention
Truncated public company reporting requirement disclosures under the Exchange Act.
49% rewrittenRisks Related to our Common Stock
Our Series A Preferred Stock and Series C Preferred Stock have liquidation preferences over our Common Stock
Added Series A Preferred Stock liquidation preferences and dividend entitlements alongside Series C preferences.
Was: The Series C Preferred Stock has a liquidation preference over our Common Stock

All 59 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Financial Condition and Capital Needs

01We have a limited operating history and history of commercializing products, which may make it difficult for you to evaluate the success of our business to date and to assess our future viabilityNew

Risks Related to Commercialization of Our Products and any Future Product Candidates

02If we are unable to successfully meet our internal development and manufacturing timelines, including the management of third-parties on which we rely, we may have delays in the expected commercial launch of XEPI and/or XEGLYZE, or we may be unable to commercialize either product at allNew
03ZELSUVMI, our approved products that have not yet been launched and any of our product candidates that receive regulatory approval, may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial successNew
04The failure of healthcare professionals or patients to perceive the benefits of using ZELSUVMI for the treatment of molluscum contagiosum instead of other alternative therapies, such as curettage, cantharidin application or cryotherapy, would adversely affect the commercial success of ZELSUVMINew
05We face substantial competition, which may result in a smaller than expected commercial opportunity and/or other firms may discover, develop or commercialize products before or more successfully than we doNew
06In addition, our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than ZELSUVMI or any other product that we may developNew
07Our gross to net (“GTN”) expenses could increase, resulting in a negative impact to our net revenues, causing a reduction in cash flow, potential impact to our stock price and have other deleterious effects to our investorsNew
08The commercial success of our products and product candidates will depend upon the degree of market acceptance by physicians, patients, third-party payers and others in the medical communityNew
09Even if a product candidate displays a favorable efficacy and safety profile in preclinical studies and clinical trials, market acceptance of the product will not be known until after it is launched. Any failure to achieve market acceptance of our products will harm our business, results and financial conditionNew
10Our products may become subject to unfavorable third-party coverage or reimbursement policies, which would harm our businessNew
11Molluscum contagiosum is a skin disease that is currently undertreated. Even with approval of ZELSUVMI in adult and pediatric patients one year and older, individuals may continue to decline treatment for molluscum contagiosum as, if left untreated, the diseases will eventually be resolved by the body’s immune systemNew
12The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label usesNew
13Product liability lawsuits could cause us to incur substantial liabilities and limit commercialization of any products that we may develop87% rewritten

Risks Related to Our Operations and Manufacturing

14injunctions, civil penalties, delays, suspension or withdrawal of approvals, seizures or recalls, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect our financial positionNew
15Our business involves the use of hazardous materials, and we and our third-party suppliers and manufacturers must comply with environmental laws and regulations, which can be expensive and restrict how we do businessNew
16The seasonal nature of our business may cause fluctuations in operationsNew
17We may be adversely affected by the effects of inflation or trade tariffsNew

Risks Related to Our Dependence on Third Parties

18We will rely on third parties to conduct any preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to obtain regulatory approval for or commercialize any of our future product candidatesNew
19any reason, we may not be able to enter into similar arrangements with alternative third parties within a short period of time or do so on commercially reasonable termsNew
20Our employees, independent contractors, principal investigators, CMOs, CROs, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could expose us to liability and hurt our reputationNew
21We sell to a limited number of wholesalers who have significant market share and if we lose our relationship with any one of those wholesalers, our revenue could be impacted and business could materially sufferNew

Risks Related to Intellectual Property

22We may ultimately need to modify our activities or technologies to design around such infringement, which may be time- and resource-consuming, and which ultimately may not be successful. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospectsNew
23Third party intellectual property may prevent us from developing our potential products; our intellectual property may not prevent competition; and any intellectual property issues may be expensive and time consuming to resolveNew
24Issued patents directed to the NITRICIL platform and technology could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroadNew
25Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing Ligand’s ability to protect our products, platform and technology on which we rely97% rewritten
26commercialize our technology and product candidates and, resultantly, on our business, financial condition, prospects and results of operationsNew
27We may be subject to claims challenging the inventorship of the patents and other intellectual property on which we relyNew
28If we are unable to protect the confidentiality of our information and our trade secrets, the value of our technology could be materially and adversely affected and our business could be harmedNew
29If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest and our competitive position may be harmedNew

Risks Related to Regulatory and Legal Compliance

30Current and future healthcare reform legislation or regulation may increase the difficulty and cost for us to commercialize our products and may adversely affect the prices we may obtain and may have a negative impact on our business and results of operationsNew
31regulations. Unexpected refunds to the government, and responding to a government investigation or enforcement action, would be expensive and time-consuming, and could have a material adverse effect on our business, financial condition, results of operations and growth prospectsNew
32Changes in and actual or perceived failures to comply with applicable data privacy, security and protection laws, regulations, standards and contractual obligations may adversely affect our business, operations and financial performanceNew
33information, necessitate the acceptance of more onerous obligations in our contracts, result in liability, or impose additional costs on us. The cost of compliance with these laws, regulations, and standards is high and likely to increase in the futureNew
34the manner in which we provide our services, the geographical location or segregation of our relevant systems and operations, and could adversely affect our financial resultsNew
35If plaintiffs bring product liability lawsuits against us or our partners, we or our partners may incur substantial liabilities and may be required to limit commercialization of our approved products, approved products not yet launched and product candidatesNew
36We face risks related to handling of hazardous materials and other regulations governing environmental safetyNew
37We may also be subject to other laws and regulations not specifically targeting the healthcare industryNew

Risks Related to our Common Stock

38The market price and trading volume of our shares of Common Stock may experience rapid and substantial price volatility, which could cause purchasers of our Common Stock to incur substantial losses
39Our Common Stock is currently listed on NYSE American. NYSE American may delist our Common Stock from trading, which could limit investors’ ability to make transactions in our securities and subject us to additional trading restrictions
40We could issue “blank check” preferred stock without stockholder approval with the effect of diluting then current stockholder interests and impairing their voting rights; and provisions in our charter documents could discourage a takeover that stockholders may consider favorable
41Our Series A Preferred Stock and Series C Preferred Stock have liquidation preferences over our Common Stock49% rewritten
42If securities or industry analysts do not publish research or reports about our business, or publish negative reports about our business, or we don’t meet expectations in those research reports, our Common Stock price and trading volume could decline95% rewritten
43The price of our securities may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our securities
44We have broad discretion in the use of our cash and may not use them effectively
45The requirements of being a public company may strain our resources and divert management’s attention72% rewritten
46business and operating results. Compliance with these rules and regulations increases our legal and financial compliance costs, makes some activities more difficult, time-consuming, or costly, and increases demand on our systems and resourcesNew
47Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain
48The occurrence of a catastrophic disaster could disrupt our business, damage our facilities beyond insurance limits, increase our costs and expenses, or we could lose key data which could cause us to curtail or cease operationsNew
49Impairment charges pertaining to goodwill, identifiable intangible assets or other long-lived assets from our mergers and acquisitions could have an adverse impact on our results of operations and our market valueNew
50Our results of operations and liquidity needs could be materially negatively affected by market fluctuations and economic downturnNew
51Our business is subject to risks arising from pandemic and epidemic diseasesNew
52The biopharmaceutical industry may be negatively affected by federal government deficit reduction policies, which could reduce the value of ZELSUVMINew
53We may pursue strategic transactions, including asset divestitures, sales, spin‑outs or other distributions, which could materially adversely affect our business, financial condition, results of operations and the value of our securitiesNew
54Our business could be adversely impacted if there are deficiencies in our disclosure controls and procedures or our internal control over financial reporting
55We have previously identified material weaknesses in our internal control over financial reporting87% rewritten
56Our failure to maintain compliance with stock exchange listing requirements could result in our Common Stock being delistedNew
57Our internal computer systems and those of our current and any future collaborators and other contractors or consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures
58Cyber-security incidents, including data security breaches or computer viruses, could harm our business by disrupting our delivery of services, damaging our reputation or exposing us to liability
59We are an “emerging growth company” and the reduced disclosure requirements applicable to emerging growth companies may make our Common Stock less attractive to investors

Other Pelthos Therapeutics 10-Ks

FY2024 10-K risk factors
66 risks
Clinical stage biopharmaceutical company focusing on pain treatments and orphan diseases faces going concern doubts and material weaknesses in internal controls.
Filed Mar 27, 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.