Inmune Bio (INMB) FY2025 10-K Risk Factors: 39 New, 31 Dropped

What the changes say

Inmune Bio faces going concern doubts with an accumulated deficit of $209,037,000 and cash of $24.8 million.
Regulatory dependence centers on CORDStrom for RDEB and potential competitors' approvals.
Capital-raising limits apply while public float remains below $75.0 million.

What changed since the prior 10-K

New

NewRISKS RELATED TO OUR BUSINESS
As of December 31, 2025, the Company had an accumulated deficit of $209,037,000. These losses primarily reflect the substantial resources devoted to research and development of our product candidates, along with general and administrative expenses, and the absence of revenues until commercialization of our products
The company reported an accumulated deficit of $209,037,000 as of December 31, 2025, raising substantial doubt about its ability to continue as a going concern.
NewRISKS RELATED TO OUR BUSINESS
We Have a History of Losses and May Never Achieve or Sustain Profitability
Net losses were $45.9 million and $42.1 million for the years ended December 31, 2025 and 2024, respectively, with only $24.8 million in cash remaining.
NewRISKS RELATED TO OUR BUSINESS
Our ability to raise additional capital, including through sales of common stock under our ATM Program, may be limited if the public float of our common stock remains below $75.0 million
The public float remaining below $75.0 million may limit capital-raising capacity through the ATM Program under SEC shelf registration rules.
NewRISKS RELATED TO OUR BUSINESS
If a competitor obtains FDA approval before us for a similar drug, approval of our product candidate may be delayed or precluded due to periods of non-patent exclusivity or patent listings by the competitor
NewRISKS RELATED TO OUR BUSINESS
Competition and Technological Change Could Reduce the Attractiveness of Our Product Candidates
NewRISKS RELATED TO OUR BUSINESS
Even if we successfully develop and obtain regulatory approval for our product candidates, there can be no assurance that physicians, patients, or payors will adopt our products as a preferred treatment. Approval of competing products before ours could further complicate our regulatory path or market acceptance
NewRISKS RELATED TO OUR BUSINESS
We are substantially dependent on the success of CORDStrom, and we may never obtain regulatory approval
The company is substantially dependent on obtaining regulatory approval for CORDStrom to treat recessive dystrophic epidermolysis bullosa.
NewRISKS RELATED TO OUR BUSINESS
Even if we commercialize our product candidates, pricing, reimbursement, and healthcare regulations could limit their market success
NewRISKS RELATED TO OUR BUSINESS
We may request priority review, but the FDA may not grant it, and even if granted, it may not accelerate approval
NewRISKS RELATED TO OUR BUSINESS
If we are unable to obtain accelerated approval or other expedited regulatory designations, development and commercialization of our product candidates may be delayed or more costly
NewRISKS RELATED TO OUR BUSINESS
Clinical drug development is lengthy, expensive, and inherently uncertain, and our product candidates may never receive regulatory approval
NewRISKS RELATED TO OUR BUSINESS
Preclinical and early-stage clinical trial results may not predict later results, and interim or preliminary data may change materially
NewRISKS RELATED TO OUR BUSINESS
Unforeseen events in clinical trials could delay or prevent marketing approval of our product candidates
NewRISKS RELATED TO OUR BUSINESS
Regulatory Approval of Product Brand Names
NewRISKS RELATED TO OUR BUSINESS
Risk of Noncompliance with Regulatory Requirements
NewRISKS RELATED TO OUR BUSINESS
Even if our product candidates are approved, they may fail to achieve sufficient market acceptance, which could limit revenue and affect our business
NewRISKS RELATED TO OUR BUSINESS
Even if we obtain regulatory approvals for CORDStrom or any product, ongoing regulation may limit our ability to manufacture and commercialize these products
NewRISKS RELATED TO OUR BUSINESS
If our product candidates are approved and later found to be less effective than expected or to cause previously unidentified side effects, our business could be materially harmed
NewRISKS RELATED TO OUR BUSINESS
Even if we obtain marketing approval for a product candidate, we will remain subject to extensive ongoing regulatory requirements, and failure to comply could materially harm our business
NewRISKS RELATED TO OUR BUSINESS
We currently have no marketing or sales organization, and our inability to establish these capabilities or collaborate with third parties could limit our product revenue
NewRISKS RELATED TO OUR BUSINESS
Our success depends largely on the continued service and performance of our principal members of management and scientific staff. The loss of any of these individuals could materially impede our ability to achieve our business objectives
NewRISKS RELATED TO OUR BUSINESS
We also rely on a significant number of consultants to support the execution of our business objectives. Any disruption in these relationships could negatively impact our operations
NewRISKS RELATED TO OUR BUSINESS
Product liability claims could result in substantial costs, divert resources, and limit the development or commercialization of our product candidates
NewRISKS RELATED TO OUR BUSINESS
We will need to expand our organization and may encounter challenges in managing this growth
NewRISKS RELATED TO OUR BUSINESS
We and our contract manufacturers are subject to extensive regulatory requirements with respect to the manufacture of our product candidates, and any failure to comply with these requirements could materially harm our business
NewRisk Related to Hazardous and Biological Materials
Current and future healthcare reform measures and pricing regulations may increase the difficulty and cost of commercializing our product candidates and may materially reduce the prices we may obtain and the revenues we may generate if any of our product candidates are approved
NewRisk Related to Hazardous and Biological Materials
Public health emergencies or other widespread health events could adversely affect our operations and financial results
NewRisk Related to Hazardous and Biological Materials
Our employees, principal investigators, consultants, and collaborators may engage in misconduct or fail to comply with regulatory requirements, which could result in liability and harm our reputation
NewRisk Related to Hazardous and Biological Materials
We rely on technology in substantially all aspects of our business operations. The widespread use of technology, including mobile devices, cloud computing, and the internet, exposes us to cybersecurity risks, such as security breaches, espionage, system disruptions, theft, and inadvertent disclosure of information
NewRisk Related to Hazardous and Biological Materials
The use or anticipated use of artificial intelligence, or AI, technologies, including generative AI, by us or third parties, may increase or create new operational risks
NewRisk Related to Hazardous and Biological Materials
The U.S. Congress, the Trump administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business
NewRisks related to government-funded intellectual property
3. Government action is necessary to meet public use requirements under federal regulations
NewRisks related to government-funded intellectual property
We rely on licenses from third parties for certain intellectual property that is necessary or useful to our business. Our licensors include Xencor, Inc., Immune Ventures, LLC, the University of Pittsburgh, and GOSH
NewRisks related to government-funded intellectual property
Potential conflict of interest with our INKmune license
NewRisks related to government-funded intellectual property
Our success depends heavily on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry is costly, complex, time-consuming, and uncertain
NewRisks Related to our Common Stock
We may fail to qualify for continued listing on The NASDAQ Capital Market which could make it more difficult for investors to sell their shares
NewRisks Related to our Common Stock
Compliance with federal securities laws and reporting requirements is costly and may divert resources from growth initiatives
NewRisks Related to our Common Stock
Our internal control over financial reporting may not meet the standards required by Section 404 of the Sarbanes-Oxley Act, and failure to achieve or maintain effective internal controls could adversely affect our business and stock price
NewRisks Related to our Common Stock
We have a stockholder rights plan designed to discourage unsolicited takeover proposals. The rights issued under this plan could result in significant dilution to any person or group attempting to acquire the Company on terms not pre-approved by our board of directors

Dropped

DroppedRISKS RELATED TO OUR BUSINESS
We face intense competition in the markets targeted by our lead product candidates. Many of our competitors have substantially greater resources than we do, and we expect that all of our product candidates under development will face intense competition from existing or future drugs
DroppedRISKS RELATED TO OUR BUSINESS
Competition and technological change may make our product candidates and technologies less attractive or obsolete
Intense competition from larger companies with greater resources.
DroppedRISKS RELATED TO OUR BUSINESS
We have incurred losses since inception and anticipate that we will continue to incur losses for the foreseeable future. We are not currently profitable, and we may never achieve or sustain profitability
DroppedRISKS RELATED TO OUR BUSINESS
Even if we are able to commercialize any product candidate that we develop, the product may become subject to unfavorable pricing regulations, third-party payor reimbursement practices or healthcare reform initiatives that could harm our business
History of losses since inception and going concern warnings.
DroppedRISKS RELATED TO OUR BUSINESS
Clinical drug development involves a lengthy and expensive process with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete the development and commercialization of our product candidate
DroppedRISKS RELATED TO OUR BUSINESS
Success in early development does not mean that later development will be successful because, for example, drug candidates in later-stage clinical trials may fail to demonstrate sufficient safety and efficacy despite having progressed through initial clinical trials
DroppedRISKS RELATED TO OUR BUSINESS
The results of preclinical studies and early-stage clinical trials may not be predictive of future results. Initial success in clinical trials may not be indicative of results obtained when these trials are completed or in later-stage trials
DroppedRISKS RELATED TO OUR BUSINESS
Interim top-line and preliminary data from our planned clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data
DroppedRISKS RELATED TO OUR BUSINESS
If we experience any of a number of possible unforeseen events in connection with clinical trials of any of our product candidates, potential marketing approval or commercialization of that product candidate could be delayed or prevented
DroppedRISKS RELATED TO OUR BUSINESS
If we experience delays or difficulties in the enrollment of patients in clinical trials, we may not achieve our clinical development on our anticipated timeline, or at all, and our receipt of necessary regulatory approvals could be delayed or prevented
DroppedRISKS RELATED TO OUR BUSINESS
We will need to obtain FDA approval of any proposed product brand names, and any failure or delay associated with such approval may adversely impact our business
DroppedRISKS RELATED TO OUR BUSINESS
We may fail to comply with regulatory requirements
DroppedRISKS RELATED TO OUR BUSINESS
Even if our product candidates receive marketing approval, they 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 and the market opportunity for the product candidates may be smaller than we estimate
DroppedRISKS RELATED TO OUR BUSINESS
Even if we obtain regulatory approvals for CORDStrom, INKmune and/or any product from our DN-TNF platform those approvals and ongoing regulation of our products may limit how we manufacture and market our products, which could prevent us from realizing the full benefit of our efforts
DroppedRISKS RELATED TO OUR BUSINESS
If our product candidates receive marketing approval and we, or others, later discover that the drug is less effective than previously believed or causes undesirable side effects that were not previously identified, our ability to market the drugs could be compromised
Requirement to obtain FDA approval for proposed product brand names.
DroppedRISKS RELATED TO OUR BUSINESS
Any product candidate for which we obtain marketing approval, along with the manufacturing processes, qualification testing, post-approval clinical data, labeling and promotional activities for such product, will be subject to continual and additional requirements of the FDA and other regulatory authorities
Failure to comply with regulatory requirements such as cGMP.
DroppedRISKS RELATED TO OUR BUSINESS
We currently have no marketing and sales organization and have no experience in marketing products. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be able to generate product revenue
DroppedRISKS RELATED TO OUR BUSINESS
We rely on key personnel and, if we are unable to retain or motivate key personnel or hire qualified personnel, we may not be able to grow effectively
DroppedRISKS RELATED TO OUR BUSINESS
Product liability lawsuits against us could divert our resources, cause us to incur substantial liabilities and limit commercialization of any products that we may develop
DroppedRISKS RELATED TO OUR BUSINESS
We will need to increase the size and capabilities of our organization, and we may experience difficulties in managing this growth
DroppedRISKS RELATED TO OUR BUSINESS
We and our contract manufacturers are subject to significant regulation with respect to manufacturing our drug candidates. The manufacturing facilities on which we rely may not continue to meet regulatory requirements
DroppedRISKS RELATED TO OUR BUSINESS
If we or 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
DroppedRISKS RELATED TO OUR BUSINESS
Current and future legislation may increase the difficulty and cost of commercializing our drug candidates and may affect the prices we may obtain if our drug candidates are approved for commercialization
DroppedRISKS RELATED TO OUR BUSINESS
Government regulations could impact our ability to price our products
DroppedRISKS RELATED TO OUR BUSINESS
Public health threats could have an adverse effect on our operations and financial results
DroppedRISKS RELATED TO OUR BUSINESS
Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading, which could cause significant liability for us and harm our reputation
DroppedRISKS RELATED TO OUR BUSINESS
A cybersecurity incident and other technological disruptions could negatively affect our business and our relationships with customers
DroppedRisks Related to our Intellectual Property
Our officers and Chairman of the Board own the company that we license our INKmune patent from
DroppedRisks Related to our Intellectual Property
Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products
DroppedRisks Related to our Common Stock
We are subject to the reporting requirements of federal securities laws, which can be expensive and may divert resources from other projects, thus impairing our ability grow
DroppedRisks Related to our Common Stock
Anti-takeover provisions in our stockholder rights plan could make a third-party acquisition of us difficult

Reworded

100% rewrittenRISKS RELATED TO OUR BUSINESS
There is a Substantial Doubt About Our Ability to Continue as a Going Concern
Updated accumulated deficit figures to $209,037,000 as of December 31, 2025, compared to $163,104,000 in the prior year.
Was: There is doubt about our ability to continue as a going concern
99% rewrittenRisks Related to our Intellectual Property
By working with research collaborators patent rights may be jointly owned by different parties
Added specific disclosures regarding joint patent ownership and indemnification rights related to patents licensed from Xencor, Inc.
99% rewrittenRISKS RELATED TO OUR BUSINESS
Our manufacturing processes are complex and subject to numerous risks that could increase costs and limit the supply of our drug candidates
Expanded manufacturing risk factors to explicitly include labor shortages, natural disasters, epidemics, pandemics, and power outages.
Was: We are subject to a multitude of manufacturing risks, any of which could substantially increase our costs and limit supply of our drug candidates
99% rewrittenRisk Related to Hazardous and Biological Materials
Deterioration in general economic conditions in the United States, Canada and globally, including the effect of prolonged periods of inflation on our suppliers, third-party service providers and potential partners, could harm our business and results of operations
Updated macroeconomic risks to highlight sustained inflationary pressures, elevated interest rates, and reduced access to capital markets.
99% rewrittenRISKS RELATED TO OUR BUSINESS
If we cannot keep pace with rapid technological changes or compete effectively, we may not operate profitably
Was: If we are unable to keep up with rapid technological changes in our field or compete effectively, we will be unable to operate profitably
99% rewrittenRisk Related to Hazardous and Biological Materials
We rely on third parties to conduct and support clinical trials for our product candidates, and any failure by these parties to meet their obligations could materially delay or impair our development programs and regulatory approvals
Was: We plan to rely on third parties to conduct clinical trials for our product candidates. Any failure by a third party to meet its obligations with respect to the clinical development of our product candidate may delay or impair our ability to obtain regulatory approval for our product candidates
98% rewrittenRISKS RELATED TO OUR BUSINESS
If clinical trials fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities, we may incur additional costs, experience delays, or be unable to commercialize our product candidates
Was: If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of the FDA and comparable non-U.S. regulators, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates
97% rewrittenRisks Related to our Common Stock
Sales of our common stock by employees, including executive officers, could cause the trading price of our common stock to decline and may be viewed negatively by investors
Was: Sales of our common shares by our employees, including our executive officers, could cause the trading price of our common shares to fall or prevent it from increasing for numerous reasons, and sales by such persons could be viewed negatively by other investors
95% rewrittenRisks Related to our Common Stock
We do not intend to pay dividends in the foreseeable future
Was: We do not intend to pay dividends for the foreseeable future
94% rewrittenRisks Related to our Intellectual Property
If we fail to protect our intellectual property rights, our ability to pursue the development of our technologies and products would be negatively affected
94% rewrittenRisks Related to our Common Stock
Additional stock offerings in the future may dilute your ownership interest in our company
Was: Additional stock offerings in the future may dilute your percentage ownership of our company
93% rewrittenRISKS RELATED TO OUR BUSINESS
We are subject to extensive government regulations
Was: We are subject to various government regulations
92% rewrittenRisks Related to our Intellectual Property
We depend on obtaining certain patents and protecting our proprietary rights
87% rewrittenRISKS RELATED TO OUR BUSINESS
We face substantial competition from other pharmaceutical and biotechnology companies and our operating results may suffer if we fail to compete effectively
78% rewrittenRisks Related to our Common Stock
You may have difficulty trading and obtaining quotations for our common stock
77% rewrittenRisk Related to Hazardous and Biological Materials
Use of Social Media Platforms Presents New Risks

All 58 risk factors

Headings as the filing states them, in filing order.

RISKS RELATED TO OUR BUSINESS

01There is a Substantial Doubt About Our Ability to Continue as a Going Concern100% rewritten
02As of December 31, 2025, the Company had an accumulated deficit of $209,037,000. These losses primarily reflect the substantial resources devoted to research and development of our product candidates, along with general and administrative expenses, and the absence of revenues until commercialization of our productsNew
03We Have a History of Losses and May Never Achieve or Sustain ProfitabilityNew
04Our ability to raise additional capital, including through sales of common stock under our ATM Program, may be limited if the public float of our common stock remains below $75.0 millionNew
05If a competitor obtains FDA approval before us for a similar drug, approval of our product candidate may be delayed or precluded due to periods of non-patent exclusivity or patent listings by the competitorNew
06Competition and Technological Change Could Reduce the Attractiveness of Our Product CandidatesNew
07Even if we successfully develop and obtain regulatory approval for our product candidates, there can be no assurance that physicians, patients, or payors will adopt our products as a preferred treatment. Approval of competing products before ours could further complicate our regulatory path or market acceptanceNew
08We are substantially dependent on the success of CORDStrom, and we may never obtain regulatory approvalNew
09Even if we commercialize our product candidates, pricing, reimbursement, and healthcare regulations could limit their market successNew
10We are subject to extensive government regulations93% rewritten
11If we cannot keep pace with rapid technological changes or compete effectively, we may not operate profitably99% rewritten
12We may request priority review, but the FDA may not grant it, and even if granted, it may not accelerate approvalNew
13If we are unable to obtain accelerated approval or other expedited regulatory designations, development and commercialization of our product candidates may be delayed or more costlyNew
14Clinical drug development is lengthy, expensive, and inherently uncertain, and our product candidates may never receive regulatory approvalNew
15Preclinical and early-stage clinical trial results may not predict later results, and interim or preliminary data may change materiallyNew
16If clinical trials fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities, we may incur additional costs, experience delays, or be unable to commercialize our product candidates98% rewritten
17Unforeseen events in clinical trials could delay or prevent marketing approval of our product candidatesNew
18Regulatory Approval of Product Brand NamesNew
19Risk of Noncompliance with Regulatory RequirementsNew
20Even if our product candidates are approved, they may fail to achieve sufficient market acceptance, which could limit revenue and affect our businessNew
21Even if we obtain regulatory approvals for CORDStrom or any product, ongoing regulation may limit our ability to manufacture and commercialize these productsNew
22If our product candidates are approved and later found to be less effective than expected or to cause previously unidentified side effects, our business could be materially harmedNew
23Even if we obtain marketing approval for a product candidate, we will remain subject to extensive ongoing regulatory requirements, and failure to comply could materially harm our businessNew
24We currently have no marketing or sales organization, and our inability to establish these capabilities or collaborate with third parties could limit our product revenueNew
25We face substantial competition from other pharmaceutical and biotechnology companies and our operating results may suffer if we fail to compete effectively87% rewritten
26Our success depends largely on the continued service and performance of our principal members of management and scientific staff. The loss of any of these individuals could materially impede our ability to achieve our business objectivesNew
27We also rely on a significant number of consultants to support the execution of our business objectives. Any disruption in these relationships could negatively impact our operationsNew
28Product liability claims could result in substantial costs, divert resources, and limit the development or commercialization of our product candidatesNew
29We will need to expand our organization and may encounter challenges in managing this growthNew
30Our manufacturing processes are complex and subject to numerous risks that could increase costs and limit the supply of our drug candidates99% rewritten
31We and our contract manufacturers are subject to extensive regulatory requirements with respect to the manufacture of our product candidates, and any failure to comply with these requirements could materially harm our businessNew

Risk Related to Hazardous and Biological Materials

32We rely on third parties to conduct and support clinical trials for our product candidates, and any failure by these parties to meet their obligations could materially delay or impair our development programs and regulatory approvals99% rewritten
33Current and future healthcare reform measures and pricing regulations may increase the difficulty and cost of commercializing our product candidates and may materially reduce the prices we may obtain and the revenues we may generate if any of our product candidates are approvedNew
34Deterioration in general economic conditions in the United States, Canada and globally, including the effect of prolonged periods of inflation on our suppliers, third-party service providers and potential partners, could harm our business and results of operations99% rewritten
35Public health emergencies or other widespread health events could adversely affect our operations and financial resultsNew
36We are exposed to risks related to currency exchange rates
37Our employees, principal investigators, consultants, and collaborators may engage in misconduct or fail to comply with regulatory requirements, which could result in liability and harm our reputationNew
38We rely on technology in substantially all aspects of our business operations. The widespread use of technology, including mobile devices, cloud computing, and the internet, exposes us to cybersecurity risks, such as security breaches, espionage, system disruptions, theft, and inadvertent disclosure of informationNew
39Use of Social Media Platforms Presents New Risks77% rewritten
40The use or anticipated use of artificial intelligence, or AI, technologies, including generative AI, by us or third parties, may increase or create new operational risks New
41The U.S. Congress, the Trump administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our businessNew

Risks Related to our Intellectual Property

42We depend on obtaining certain patents and protecting our proprietary rights92% rewritten
43If we fail to protect our intellectual property rights, our ability to pursue the development of our technologies and products would be negatively affected94% rewritten
44By working with research collaborators patent rights may be jointly owned by different parties 99% rewritten

Risks related to government-funded intellectual property

453. Government action is necessary to meet public use requirements under federal regulationsNew
46We rely on licenses from third parties for certain intellectual property that is necessary or useful to our business. Our licensors include Xencor, Inc., Immune Ventures, LLC, the University of Pittsburgh, and GOSHNew
47We are dependent on our licensing agreement with Xencor, and the termination of this agreement would harm our business
48Potential conflict of interest with our INKmune licenseNew
49Our success depends heavily on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry is costly, complex, time-consuming, and uncertainNew

Risks Related to our Common Stock

50We may fail to qualify for continued listing on The NASDAQ Capital Market which could make it more difficult for investors to sell their sharesNew
51We do not intend to pay dividends in the foreseeable future95% rewritten
52Compliance with federal securities laws and reporting requirements is costly and may divert resources from growth initiativesNew
53Our stock price may be volatile
54You may have difficulty trading and obtaining quotations for our common stock78% rewritten
55Additional stock offerings in the future may dilute your ownership interest in our company94% rewritten
56Our internal control over financial reporting may not meet the standards required by Section 404 of the Sarbanes-Oxley Act, and failure to achieve or maintain effective internal controls could adversely affect our business and stock priceNew
57We have a stockholder rights plan designed to discourage unsolicited takeover proposals. The rights issued under this plan could result in significant dilution to any person or group attempting to acquire the Company on terms not pre-approved by our board of directorsNew
58Sales of our common stock by employees, including executive officers, could cause the trading price of our common stock to decline and may be viewed negatively by investors97% rewritten

Other Inmune Bio 10-Ks

FY2024 10-K risk factors
50 risks
The company faces an accumulated deficit of $163,104,000 with a going concern warning and relies on third-party manufacturers.
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.