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What changed in Inmune Bio, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Inmune Bio, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+723 added−819 removedSource: 10-K (2026-03-30) vs 10-K (2024-12-31)

Top changes in Inmune Bio, Inc.'s 2025 10-K

723 paragraphs added · 819 removed · 199 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

65 edited+357 added−288 removed25 unchanged
Biggest changeThe process required by the FDA before prescription drug product candidates may be marketed in the United States generally involves the following: ● completion of extensive nonclinical laboratory tests, animal studies and formulation studies, all performed in accordance with the FDA’s Good Laboratory Practice regulations; ● submission to the FDA of an investigational new drug application, or IND, which must become effective before human clinical trials may begin; ● for some products, performance of adequate and well-controlled human clinical trials in accordance with the FDA’s regulations, including Good Clinical Practices, to establish the safety and efficacy of the product candidate for each proposed indication; ● submission to the FDA of a new drug application or NDA; ● satisfactory completion of an FDA preapproval inspection of the manufacturing facilities at which the product is produced to assess compliance with current Good Manufacturing Practice, or cGMP, regulations; and ● FDA review and approval of the NDA prior to any commercial marketing, sale or shipment of the drug.
Biggest changeThe process required by the FDA before biologic product candidates may be marketed in the United States generally involves the following: ● completion of preclinical laboratory tests and animal studies performed in accordance with the FDA’s current Good Laboratory Practices (“GLP”) regulation; ● submission to the FDA of an Investigational New Drug Application (“IND”), which must become effective before clinical trials may begin and must be updated annually or when significant changes are made; ● approval by an independent institutional review board (“IRB”), or ethics committee at each clinical site before the trial is commenced; 14 ● manufacture of the proposed biologic candidate in accordance with Current Good Manufacturing Practices (“cGMPs”); ● performance of adequate and well-controlled human clinical trials in accordance with Good Clinical Practice (“GCP”) requirements to establish the safety, purity and potency of the proposed biologic product candidate for its intended purpose; ● preparation of and submission to the FDA of a BLA, after completion of all pivotal clinical trials; ● satisfactory completion of an FDA Advisory Committee review, if applicable; ● a determination by the FDA within 60 days of its receipt of a BLA to file the application for review; ● satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced to assess compliance with cGMPs, and to assure that the facilities, methods and controls are adequate to preserve the biological product’s continued safety, purity and potency, and of selected clinical investigation sites to assess compliance with GCPs; and ● FDA review and approval of a BLA to permit commercial marketing of the product for particular indications for use in the United States.
On July 20, 2018 and October 30, 2020, the parties amended the agreement under which the Company was required achieve milestones pursuant to the agreement. On April 17, 2023, the parties executed an additional amendment to the agreement under which the Company removed the due diligence requirements to achieve reasonable commercial efforts to bring INKmune to market.
On July 20, 2018 and October 30, 2020, the parties amended the agreement under which the Company was required to achieve milestones pursuant to the agreement. On April 17, 2023, the parties executed an additional amendment to the agreement under which the Company removed the due diligence requirements to achieve reasonable commercial efforts to bring INKmune to market.
One commercial application of INKmune includes use as a therapeutic composition designed to enhance the ability of a patient’s own NK cells to seek, recognize and eliminate cancer. Another commercial application of INKmune includes use as a cytokine-like (“pseudokine”) agent for enhancing NK cell killing specificity, potency, and efficacy of NK cell -based therapeutics.
One commercial application of INKmune includes use as a therapeutic composition designed to enhance the ability of a patient’s own NK cells to seek, recognize and eliminate cancer. Another commercial application of INKmune includes use as a cytokine-like agent for enhancing NK cell killing specificity, potency, and efficacy of NK cell -based therapeutics.
Changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting requirements upon us and any third-party manufacturers that we may decide to use.
Changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMPs and impose reporting requirements upon us and any third-party manufacturers that we may decide to use.
The following table summarizes current IP covering our DN-TNF platform technology: Subject Matter / Compound # Pending Applications # Issued Patents Geographical Scope Nominal Patent Term DNTNF compositions and formulations 2 0 global 2044-2045 Use of DNTNF for treating disease 19 10 global 2033-2041 DNTNF manufacturing/CMC 1 0 global 2045 INB-16 / INKmune (Oncology) INKmune is a replication-incompetent derivative of our proprietary INB-16 cell line.
The following table summarizes current IP covering our DN-TNF platform technology: Subject Matter / Compound # Pending Applications # Issued Patents Geographical Scope Nominal Patent Term DNTNF compositions and formulations 2 0 global 2044-2045 Use of DNTNF for treating disease 14 8 global 2033-2045 DNTNF manufacturing/CMC 1 0 global 2045 INB-16 / INKmune (Oncology) INKmune is a replication-incompetent derivative of our proprietary INB-16 cell line.
Pharmaceutical manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with GMP, which impose certain procedural and documentation requirements upon us and our third-party manufacturers.
Biologic manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMPs, which impose certain procedural and documentation requirements upon us and our third-party manufacturers.
Trademarks The designations INMUNE BIO TM , INB16 TM , INKmune TM , PSEUDOKINE TM , and XPro TM are trademarks of INmune Bio Inc. Some or all these trademarks may be protected by applications pending at the USPTO and other trademark registration authorities globally.
Trademarks The designations INMUNE BIO TM , CORDStrom TM , INB16 TM , INKmune TM , XPro1595 TM and XPro TM are trademarks of INmune Bio Inc. Some or all these trademarks may be protected by registrations or applications pending at the USPTO and other trademark registration authorities globally.
(“Xencor”), which has discovered and developed a proprietary biological molecule that inhibits soluble tumor necrosis factor (the “Xencor Agreement”). During June 2021, the Company entered into the First Amendment to License Agreement with Xencor.
Xencor License Agreement On October 3, 2017, the Company entered into a license agreement with Xencor, Inc. (“Xencor”), which has discovered and developed a proprietary biological molecule that inhibits soluble tumor necrosis factor (the “Xencor Agreement”). During June 2021, the Company entered into the First Amendment to License Agreement with Xencor.
While each invention is unique and territories for protection are decided on a case-by-case basis, we generally pursue patents in Australia, Canada, Europe, Japan, and the United States, and sometimes in Brazil, China and/or Korea. We currently have in our portfolio fifteen (15) issued patents and thirty (30) pending patent applications, including both company-owned and in-licensed properties.
While each invention is unique and territories for protection are decided on a case-by-case basis, we generally pursue patents in Australia, Canada, Europe, Japan, and the United States, and sometimes in Brazil, China and/or Korea. We currently have in our portfolio thirteen (13) issued patents and twenty-seven (27) pending patent applications, including both company-owned and in-licensed properties.
Licensor may terminate the PITT Agreement upon written notice if: (i) the Company defaults as to performance of material obligations which have not been cured within 60 days after receiving written notice; or (ii) the Company ceases to carry out its business, becomes bankrupt or insolvent, applies for or consents to the appointment of a trustee, receiver or liquidator of its assets or seeks relief under any law for the aid of debtors. 19 Xencor License Agreement On October 3, 2017, the Company entered into a license agreement with Xencor, Inc.
Licensor may terminate the PITT Agreement upon written notice if: (i) the Company defaults as to performance of material obligations which have not been cured within 60 days after receiving written notice; or (ii) the Company ceases to carry out its business, becomes bankrupt or insolvent, applies for or consents to the appointment of a trustee, receiver or liquidator of its assets or seeks relief under any law for the aid of debtors.
The following table summarizes current IP covering our CORDStrom platform technology: Subject Matter / Compound # Pending Applications # Issued Patents Geographical Scope Nominal Patent Term CORDStrom compositions and formulations 1 0 global 2045 Use of CORDStrom for treating disease 1 0 global 2045 General IP Disclosures Our commercial success depends in part on obtaining and maintaining patent and trade secret protections, where applicable, of our current and future product candidates and the methods used to manufacture them, as well as successfully defending our patents against third-party challenges.
The following table summarizes current IP covering INB-16 / INKmune: Subject Matter / Compound # Pending Applications # Issued Patents Geographical Scope Nominal Patent Term INB-16 / INKmune compositions 4 0 global 2043 Use of INKmune for treating disease 3 5 global 2036-2043 11 General IP Disclosures Our commercial success depends in part on obtaining and maintaining patent and trade secret protections, where applicable, of our current and future product candidates and the methods used to manufacture them, as well as successfully defending our patents against third-party challenges.
Initially developed at the INKmune manufacturing facilities utilizing United Kingdom academic grant funding, CORDStrom is a mesenchymal stromal cell (“MSC”) product platform that shows promise as a first systemic therapy for potentially treating RDEB and many other debilitating conditions.
Initially developed at the INKmune manufacturing facilities utilizing United Kingdom academic grant funding, CORDStrom is a product platform that shows promise as a therapy for RDEB and many other debilitating conditions.
In addition, the Company owns IP and maintains trade secret protections covering the manufacturing of CORDStrom. With this license to the clinical trial data, the Company intends to prepare applications seeking marketing authorization of CORDStrom for treatment of pediatric recessive dystrophic epidermolysis bullosa (“RDEB”) in each of the FDA, EMA, and MHRA.
With this license to the clinical trial data, the Company intends to prepare applications seeking marketing authorization of CORDStrom for treatment of pediatric recessive dystrophic epidermolysis bullosa (“RDEB”) in each of the FDA, EMA, and MHRA.
Terms of the GOSH license include an upfront payment of £250,000 (approximately $0.3 million at February 6, 2025) and a single milestone payment of up to £6,000,000 (approximately $7.5 million at February 6, 2025) due on the first to occur marketing authorization to be granted by the FDA, EMA or MHRA.
Terms of the GOSH license include an upfront payment of £250,000 (approximately $0.3 million) which the Company paid during 2025 and a single milestone payment of up to £6,000,000 (approximately $8.1 million at December 31, 2025) due on the first to occur marketing authorization to be granted by the FDA, EMA or MHRA.
HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA and seek attorney’s fees and costs associated with pursuing federal civil actions.
HITECH also increased the civil and criminal penalties applicable to covered entities and business associates and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA and seek attorneys’ fees and costs associated with pursuing federal civil actions.
Orphan drug designation must be requested before submitting an NDA. After orphan drug designation is granted, the identity of the therapeutic agent and its potential orphan use are publicly disclosed. Orphan drug designation does not convey an advantage in, or shorten the duration of, the review and approval process.
Orphan drug designation must be requested before submitting a BLA. After the FDA grants orphan drug designation, the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. The orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review or approval process.
The FDA closely regulates the marketing, labeling, advertising and promotion of pharmaceutical products. A company can make only those claims relating to safety and efficacy, purity and potency that are approved by the FDA and in accordance with the provisions of the approved label.
The FDA closely regulates the marketing, labeling, advertising and promotion of biologics. A company can make only those claims relating to safety and efficacy, purity and potency that are approved by the FDA and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
University of Pittsburg License Agreement On October 3, 2017, the Company entered into an Assignment and Assumption Agreement with Immune Ventures related to intellectual property licensed from the University of Pittsburgh.
All other provisions in the INKmune License Agreement shall continue in full force and effect. 12 University of Pittsburg License Agreement On October 3, 2017, the Company entered into an Assignment and Assumption Agreement with Immune Ventures related to intellectual property licensed from the University of Pittsburgh.
In consideration for the INKmune License, we are obligated to pay Immune Ventures certain milestone and royalty payments. 18 The term of the Immune Ventures Agreement began on October 29, 2015, and, if not terminated sooner pursuant to the agreement, ends on a country-by-country basis on the date of the expiration of the last to expire patent rights where patent rights exist.
The term of the Immune Ventures Agreement began on October 29, 2015, and, if not terminated sooner pursuant to the agreement, ends on a country-by-country basis on the date of the expiration of the last to expire patent rights where patent rights exist.
The FDA, an IRB or we may suspend a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk.
Regulatory authorities, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives.
Although there are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly. Practices that involve remuneration that may be alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor.
There are a number of statutory exceptions and regulatory safe harbors protecting some common commercial activities from AKS prosecution, but they are drawn narrowly and practices that involve remuneration, such as consulting agreements, for persons in a position to refer or recommend federally reimbursable healthcare business may be alleged to be intended to induce prescribing, purchasing or recommending, and may be subject to scrutiny if they do not qualify for an exception or regulatory safe harbor.
Post-Approval Requirements Any products manufactured or distributed by us pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, distribution, and advertising and promotion of the product.
Becerra suggested that orphan drug exclusivity covers the full scope of the orphan-designated “disease or condition” regardless of whether a drug obtained approval for a narrower use. 19 Post-Approval Requirements Any products manufactured or distributed by us pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution, and advertising and promotion of the product.
An IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions relating to the proposed clinical trials as outlined in the IND and places the clinical trial on a clinical hold.
The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day period, raises safety concerns or questions about the proposed clinical trial.
After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There also are continuing, annual user fee requirements for any marketed products and the establishments at which such products are manufactured, as well as new application fees for supplemental applications with clinical data.
After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There also are continuing user fee requirements, under which the FDA assesses an annual program fee for each product identified in an approved BLA.
This removed all requirements of clinical trial timelines and the filing timelines of an NDA or equivalent. All other provisions in the INKmune License Agreement shall continue in full force and effect.
This removed all requirements of clinical trial timelines and the filing timelines of an NDA or equivalent.
CORDStrom License Agreement – Clinical Trial Data On February 6, 2025, the Company and Great Ormond Street Hospital NHS Foundation Trust (“GOSH”) executed an exclusive commercial use license to clinical trial data associated with the MissionEB trial (ISRCTN14409785). The Company owns the intellectual property covering the CORDStrom product, the investigational medicinal product (“IMP”) used in the MissionEB trial.
In consideration of the Xencor Agreement, we agreed to royalty payments and a percentage of any payments received in exchange for a sub-license. 13 CORDStrom License Agreement – Clinical Trial Data On February 6, 2025, the Company and Great Ormond Street Hospital NHS Foundation Trust (“GOSH”) executed an exclusive commercial use license to clinical trial data associated with the MissionEB trial (ISRCTN14409785).
To our knowledge, there are no innate immune check-point inhibitors in development that have the unique characteristics of INB03 that neutralize sTNF to: i) decreases the proliferation of MDSC; ii) decreasing local and systemic immunosuppression caused by MDSC by stopping production of immunosuppressive cytokines and iii) improving NK/DC cross-talk to recruit the adaptive immune system to fight the cancer. 16 Intellectual Property We seek to protect our therapeutic programs by continuously developing patent properties covering novel compositions, formulations, purpose-limited compositions, combination treatments, methods of medical treatment, and other inventions, whether created internally or in-licensed, in the United States Patent & Trademark Office (the “USPTO”), the World Intellectual Property Organization (“WIPO”) under the Patent Cooperation Treaty (“PCT”), and in patent offices for various foreign jurisdictions.
Intellectual Property We seek to protect our therapeutic programs by continuously developing patent properties covering novel compositions, formulations, purpose-limited compositions, combination treatments, methods of medical treatment, and other inventions, whether created internally or in-licensed, in the United States Patent & Trademark Office (the “USPTO”), the World Intellectual Property Organization (“WIPO”) under the Patent Cooperation Treaty (“PCT”), and in patent offices for various foreign jurisdictions.
We consider the intellectual capital of our employees to be an important driver of our business and key to our future prospects. We monitor our compensation programs closely and provide what we consider to be a very competitive mix of compensation and insurance benefits for all our employees, as well as participation in our equity programs.
We monitor our compensation programs closely and provide what we consider to be a very competitive mix of compensation and insurance benefits for all our employees, as well as participation in our equity programs. None of our employees is subject to a collective bargaining agreement or represented by a trade or labor union.
While the first generation CORDStrom product is agnostic to disease indication, the platform enables creation of indication-specific products, which can be tuned for optimization of anti-inflammatory, immunomodulatory, homing, and other characteristics.
While the first generation CORDStrom product is agnostic to indication, the platform enables creation of indication-specific products, which can be tuned for optimization of anti-inflammatory, immunomodulatory, wound healing, and other characteristics. 1 Children with RDEB have skin that is damaged by even the smallest amount of friction which causes severe blistering, deep wounds, and scars.
Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain compliance with cGMP and other aspects of regulatory compliance.
Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain compliance with cGMPs and other aspects of regulatory compliance. The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.
Remuneration has been broadly defined to include anything of value, including cash, improper discounts, and free or reduced-price items and services. The federal Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on one hand and prescribers, purchasers, formulary managers, and beneficiaries on the other.
The term remuneration has been interpreted broadly to include anything of value. The AKS has been interpreted to apply to arrangements between pharmaceutical manufacturers on one hand, and prescribers and purchasers on the other.
The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the Affordable Care Act, among other things, imposed new reporting requirements on certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, for payments or other transfers of value made by them to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
The U.S. federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to annually report to the Centers for Medicaid & Medicare Services (“CMS”) information related to payments or other transfers of value to various healthcare professionals including physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, certified nurse-midwives, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
Physicians may prescribe legally available products for uses that are not described in the product’s labeling and that differ from those tested by us and approved by the FDA. Such off-label uses are common across medical specialties. Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances.
Such off-label uses are common across medical specialties. Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments.
In addition, the federal government, state legislatures, and foreign governments have shown significant interest in implementing cost containment programs, including price-controls and price transparency, restrictions on reimbursement, and requirements for substitution of generic products for branded prescription drugs to limit the growth of government paid health care costs.
In addition, the U.S. government, state legislatures and foreign governments have continued implementing cost-containment programs, including price controls, restrictions on coverage and reimbursement and requirements for substitution of generic products. The IRA provides CMS with significant new authorities intended to curb drug costs and to encourage market competition.
Like the federal Anti-Kickback Statute, the Affordable Care Act amended the intent standard for certain healthcare fraud statutes under HIPAA such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
A person or entity does not need to have actual knowledge of the healthcare fraud statute implemented under HIPAA or specific intent to violate the statute in order to have committed a violation.
Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the federal Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all its facts and circumstances.
Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the AKS, but it does increase the risk of regulatory scrutiny.
The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. Failure to comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties.
Failure to comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties. Physicians may prescribe legally available products for uses that are not described in the product’s labeling and that differ from those tested by us and approved by the FDA.
Third-party payors are increasingly challenging the price, examining the cost-effectiveness, and reducing reimbursement for medical products and services. In addition, significant uncertainty exists as to the reimbursement status of newly approved healthcare products.
Third-party payors are increasingly challenging the prices charged for medical products and services, examining the medical necessity and reviewing the cost effectiveness of pharmaceutical or biological products, medical devices and medical services, in addition to questioning safety and efficacy.
The CORDStrom platform leverages, among other things, proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled HucMSCs as medicines to treat complex inflammatory diseases. CORDStrom products are designed to provide high-quality, off-the-shelf, batch-to-batch consistent, scalable, cGMP manufactured, potent cellular medicines that can be produced at low cost and with repeatable specification independent of donor characteristics.
CORDStrom is manufactured in the United Kingdom under the direction of Mark Lowdell, the Company’s CSO, using a supply of human umbilical cords. CORDStrom products are designed to provide high-quality, off-the-shelf, batch-to-batch consistent, scalable, cGMP manufactured, potent cellular medicines that can be produced at low cost and with repeatable specification.
Further, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which have resulted in several Congressional inquiries and proposed bills designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for products.
In addition, the Bipartisan Budget Act of 2018, among other things, amended the Medicare Act (as amended by the ACA) to increase the point-of-sale discounts that manufacturers must agree to offer under the Medicare Part D coverage discount program from 50% to 70% off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs being covered under Medicare Part D. 26 Moreover, there has recently been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state measures designed to, among other things, reduce the cost of prescription drugs, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products.
In such cases, the IND sponsor and the FDA must resolve any outstanding concerns or questions before any clinical trials can begin. Clinical trial holds also may be imposed at any time before or during studies due to safety concerns or non-compliance with regulatory requirements.
In such a case, the IND may be placed on clinical hold and the IND sponsor and the FDA must resolve any outstanding concerns or questions before the clinical trial can begin. Submission of an IND therefore may or may not result in FDA authorization to begin a clinical trial.
None of our employees is subject to a collective bargaining agreement or represented by a trade or labor union. We consider our relations with our employees to be good. Corporate Information We were incorporated under the laws of the State of Nevada on September 25, 2015.
We consider our relations with our employees to be good. Corporate Information We were incorporated under the laws of the State of Nevada on September 25, 2015. Our principal executive office is located at 225 NE Mizner Blvd, Suite 640, Boca Raton FL 33432 and our telephone number is (561) 710-0512.
The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, created additional federal criminal statutes that prohibit, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors; knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services; and willfully obstructing a criminal investigation of a healthcare offense.
Under the AKS, for example, a claim resulting from a violation of the AKS is deemed to be a false or fraudulent claim for purposes of the FCA. 22 HIPAA created additional federal criminal statutes that prohibit, among other things, executing a scheme to defraud any healthcare benefit program, including private third-party payors, and making false statements relating to healthcare matters.
CORDStrom solves certain manufacturing and CMC limitations known to affect mesenchymal stem/stromal cell products, namely, improved batch-to-batch consistency and scalable manufacturing. We have filed patent applications directed to CORDStrom including claims covering composition of matter, formulation, and methods of treating various disease indications. In addition, we protect manufacturing trade secrets with a series of confidentiality provisions in various agreements.
CORDStrom solves certain manufacturing and CMC limitations known to affect mesenchymal stem/stromal cell products, namely, improved batch-to-batch consistency and scalable manufacturing.
In addition, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product does not undergo unacceptable deterioration over its shelf life. Prior to approval, the FDA will conduct an inspection of the manufacturing facilities to assess compliance with cGMP. The FDA reviews all NDAs submitted before it accepts them for filing.
Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life. A sponsor may choose, but is not required, to conduct a foreign clinical study under an IND.
HIPAA, as amended by the Health Information Technology and Clinical Health Act, or HITECH, and their respective implementing regulations, imposes specified requirements on certain health care providers, plans and clearinghouses (collectively, “covered entities”) and their “business associates,” relating to the privacy, security and transmission of individually identifiable health information.
For example, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and their respective implementing regulations impose data privacy, security, and breach notification obligations on certain health care providers, health plans, and health care clearinghouses, known as covered entities, as well as their business associates and their covered subcontractors that perform certain services that involve using, disclosing, creating, receiving, maintaining, or transmitting individually identifiable protected health information (“PHI”) for or on behalf of such covered entities.
Phase 3 clinical trials are intended to establish the overall risk-benefit ratio of the product candidate and provide an adequate basis for product labeling.
The investigational product is administered to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval.
If a product that has an orphan drug designation subsequently receives the first regulatory approval for the indication for which it has such designation, the product is entitled to orphan exclusivity, meaning that the applicable regulatory authority may not approve any other applications to market the same drug for the same indication, except in limited circumstances, for a period of seven years in the United States and 10 years in the European Union Orphan drug designation does not prevent competitors from developing or marketing different drugs for the same indication or the same drug for different indications.
If a product that has orphan drug designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan drug exclusive approval (or exclusivity), which means that the FDA may not approve any other applications, including a full BLA, to market the same product for the same approved use or indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity by means of greater effectiveness, greater safety or providing a major contribution to patient care or if the holder of the orphan drug exclusivity cannot assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the same use or indication for which the already-approved or licensed product was approved or licensed.
If our future suppliers are not able to comply with these requirements, the FDA may, among other things, halt our clinical trials, require us to recall a product from distribution, or withdraw approval of the product. 25 The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.
The FDA also may condition approval on, among other things, changes to proposed labeling or the development of adequate controls and specifications. Once approved, the FDA may withdraw the product approval if compliance with pre- and post-marketing requirements is not maintained or if problems occur after the product reaches the marketplace.
These include accelerated approval under Subpart H of the agency’s NDA approval regulations, fast track drug development procedures and priority review. 22 The United States, European Union and other jurisdictions may grant orphan drug designation to drugs intended to treat a “rare disease or condition,” which, in the United States, is generally a disease or condition that affects no more than 200,000 individuals.
Orphan Drug Designation and Exclusivity Under the Orphan Drug Act of 1983, the FDA may grant orphan drug designation to a product candidate intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or 200,000 or more individuals in the United States for which there is no reasonable expectation that the cost of developing and making available in the United States a drug or biologic for this type of disease or condition will be recovered from sales in the United States for that product candidate.
The government has enforced the federal Anti-Kickback Statute to reach large settlements with healthcare companies based on sham research or consulting and other financial arrangements with physicians. Further, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation.
Ultimately, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
An NDA applicant must develop information about the chemistry and physical characteristics of the drug and finalize a process for manufacturing the product in accordance with cGMP. The manufacturing process must be capable of consistently producing quality product within specifications approved by the FDA. The manufacturer must develop methods for testing the quality, purity and potency of the final product.
The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, must develop methods for testing the identity, strength, quality and purity of the final product, or for biologics, the safety, purity and potency.
In the European Union, orphan drug designation can be granted if: the disease is life threatening or chronically debilitating and affects no more than 50 in 100,000 persons in the European Union; without incentive it is unlikely that the drug would generate sufficient return to justify the necessary investment; and no satisfactory method of treatment for the condition exists or, if it does, the new drug will provide a significant benefit to those affected by the condition.
In addition, orphan drug designation can be granted if, for economic reasons, the medicinal product would be unlikely to be developed without incentives and if there is no other satisfactory method approved in the EU of diagnosing, preventing, or treating the condition, or if such a method exists, the proposed medicinal product is a significant benefit to patients affected by the condition.
The Company has enrolled a global blinded randomized Phase II trial in ADi patients with Early AD in Australia, Canada, the United Kingdom, Spain, France, Germany, Poland, the Czech Republic, and Slovakia. Early AD is patients that have Mild Cognitive Impairment or mild AD.
The AD program had sites in Australia, Canada, the United Kingdom, France, Germany, Spain, Czech Republic and Slovakia. Full enrollment in the Phase II AD trial occurred in late 2024 with 208 patients enrolled and top-line data was received during June 2025.
The following table summarizes current IP covering INB-16 / INKmune: Subject Matter / Compound # Pending Applications # Issued Patents Geographical Scope Nominal Patent Term INB-16 / INKmune compositions 5 0 global 2043 Use of INKmune for treating disease 4 5 global 2036-2043 17 CORDStrom (MSCs) CORDstrom is a cell suspension for intravenous infusion or injection comprising aseptic, allogeneic, pooled HucMSCs.
The following table summarizes current IP covering our CORDStrom platform technology: Subject Matter / Compound # Pending Applications # Issued Patents Geographical Scope Nominal Patent Term CORDStrom compositions and formulations 2 0 global 2045 Use of CORDStrom for treating disease 1 0 global 2045 DN-TNF Platform Technology The DN-TNF Platform Technology covers a variety of dominant negative tumor necrosis factor variant proteins, including the pegylated DN-TNF protein variants known as XPro and INB03.
XPro1595 (“XPro”), targets Alzheimer’s Disease and TRD. XPro for AD has completed Phase I trials and a Phase II trial has completed enrollment of patients at clinical sites in the United Kingdom, EU, Australia and Canada. Patients are currently being treated with XPro for Early AD as part of that clinical trial. TRD is being prepared for Phase II trials.
XPro has completed Phase I and Phase II clinical trials for the treatment of Alzheimer’s Disease (AD), with enrollment spanning clinical sites in the United Kingdom, the European Union, Australia, and Canada. ● INKmune™ : A novel natural killer (NK) cell-priming platform designed to harness the patient’s own innate immune system to eliminate cancer cells.
We plan to file for Biologics License Application (“BLA”), an approval document for full approval of CORDStrom with the FDA in late 2025 or early 2026. We also plan to file for Marketing Authorization Application in the EU and United Kingdom in 2026 with CORDStrom for RDEB.
We intend to file a Marketing Authorization Application (MAA) in the United Kingdom in July 2026 and the European Union (EU) in September 2026, followed by a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) targeted for December 2026.
An independent institutional review board, or IRB, at each of the clinical centers proposing to conduct the clinical trial must review and approve the plan for any clinical trial before it commences at that center. An IRB considers, among other things, whether the risks to individuals participating in the trials are minimized and are reasonable in relation to anticipated benefits.
Furthermore, an independent IRB for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent form before the clinical trial begins at that site, and must monitor the study until completed.
In addition, certain states have their own laws that govern the privacy and security of health information in certain circumstances, many of which differ from each other and/or HIPAA in significant ways and may not have the same effect, thus complicating compliance efforts. 27 Coverage and Reimbursement Sales of pharmaceutical products depend significantly on the extent to which coverage and adequate reimbursement are provided by third-party payors.
Numerous other states have passed similar laws, but many differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
We cannot predict what effect further changes to the ACA would have on our business. Additionally, other federal health reform measures have been proposed and adopted in the United States since the ACA was enacted, including the Budget Control Act of 2011, which includes provisions to reduce the federal deficit.
Other legislative changes have been proposed and adopted since the ACA was enacted, including automatic aggregate reductions of Medicare payments to providers of on average 2% per fiscal year as part of the federal budget sequestration under the Budget Control Act of 2011.
The clinical trial is an open label Phase I/II trial in men with metastatic castrate resistant prostate cancer. The trial has a modified Baysian design that allows for a 3 patient Phase I for each dose level followed by a 6 patient Phase II trial. All patients will receive 3 infusions of INKmune on days 1, 8 and 15.
The Company initiated a separate multicenter Phase I/II trial of INKmune in a metastatic castrate resistant prostate cancer in the US and enrolled the first patient in December 2023. The Company’s Phase I/II trial using INKmune to treat patients with metastatic castrate resistant prostate cancer (mCPRC) is an open label trial.
We have added CORDStrom, a pooled, human umbilical cord mesenchymal stem cell (“HucMSC”) product to treat recessive dystrophic epidermolysis bullosa (“RDEB”), a pediatric orphan disease caused by mutations in the COL7A1 gene that results in a debilitating disease of skin blistering, dysphagia and failure to thrive with chronic wound problems that often results in fatal squamous cell carcinoma.
Lead Program : CORDStrom™ for RDEB Our primary focus is the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) using CORDStrom, our proprietary, pooled, human umbilical cord-derived mesenchymal stromal cell platform. RDEB is a devastating pediatric orphan disease caused by mutations in the COL7A1 gene.
In consideration of the Xencor Agreement, we agreed to royalty payments and a percentage of any payments received in exchange for a sub-license.
In consideration for the INKmune License, we are obligated to pay Immune Ventures certain milestone and royalty payments.
New Drug Applications Assuming successful completion of the required clinical trials, the results of product development, preclinical studies and clinical trials are submitted to the FDA as part of an NDA. An NDA also must contain extensive manufacturing information, as well as proposed labeling for the finished product.
BLA Submission and Review Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development, nonclinical studies and clinical trials are submitted to the FDA as part of a BLA requesting approval to market the product for one or more indications.
We may also be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business.
Other Healthcare Laws and Compliance Requirements Pharmaceutical companies are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they conduct their business.
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Item 1. Business Our Strategy Our objective is to develop and commercialize our product candidates to treat diseases where the innate immune system is dysfunctional causing or contributing to the patient’s disease. Innate immune dysfunction can occur for a variety of reasons including genetics, lifestyle, and other factors. However, age plays a significant role in the development of immune dysfunction.
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Item 1. Business Our Strategy Company Overview INmune Bio is a clinical-stage biotechnology company dedicated to developing and commercializing a pipeline of product candidates designed to reprogram the innate immune system. Our mission is to address a broad range of diseases where chronic inflammation and immune dysfunction are primary drivers of pathology.
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Innate immune dysfunction can be seen in cancer where Natural Killer (“NK”) cells are impaired and facilitate a tumor’s evasion of the immune system and subsequent disease progression. Chronic inflammation is implicated in neurologic and metabolic diseases where it impairs the innate immune system.
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This genetic deficiency leads to systemic complications, including highly debilitating skin blistering, chronic non-healing wounds, dysphagia, and failure to thrive. Over time, the chronic inflammatory environment associated with RDEB often progresses to fatal squamous cell carcinoma. RDEB is a systemic disease with no approved systemic treatments.
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Our initial focus continue to be treatment of cancer with INKmune and Alzheimer’s Disease (“AD”) and Treatment Resistant Depression (“TRD”) with XPro1595.
Added
The only approved products to date are topical and do not address the systemic issues of the disease, which is the focus of CORDStrom. CORDStrom has recently completed a pivotal, blinded, randomized cross-over trial. Based on these data, the Company is transitioning toward regulatory submission and commercialization.
Removed
We expect to start a pivotal global registration trial in patients with AD after the results of the Phase II trial have been analyzed. The INKmune program is in an open label Phase II trial in metastatic castrate resistant prostate cancer (“mCRPC”). CORDStrom for the treatment of children with RDEB has completed a pivotal blinded randomized cross-over trial.
Added
Neuroin flammation and Oncology Pipelines In addition to our lead rare disease program, the Company is advancing two other clinical-stage platforms: ● XPro1595 (XPro) : A next-generation protein therapeutic that targets neuroinflammation by selectively neutralizing soluble TNF.
Removed
The data will be submitted for a marketing authorization (“BLA”) in the US in the next 12-18 months.
Added
The INKmune program is currently nearing the completion of an open-label Phase II trial for the treatment of metastatic castrate-resistant prostate cancer (mCRPC). By targe ting the innate immune system across these distinct therapeutic areas, INmune Bio aims to deliver disease-modifying treatments for patients with high unmet medical needs.
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The overall principal components of our business strategy to achieve these objectives are to: ● Pursue a registration strategy for CORDStrom in RDEB that maximizes the value of the therapy and expand the CORDStrom platform; ● Pursue development strategies and regulatory approval pathways that allow the treatment of neurodegenerative diseases in patients with our lead product candidate, XPro; ● Pursue development strategies and regulatory approval pathways that allow the treatment cancer with our lead oncology platform, INKmune; ● Adopt a product development strategy that solidifies our existing intellectual property (“IP”) to prevent competition and expand our IP suite into related immunotherapeutic areas; ● Provide clear value propositions to third-party payers, such as managed care companies or government programs like Medicare, to merit reimbursement for our product candidates; and ● Collaborate with other pharmaceutical companies with respect to, among other things, our XPro, CORDStrom and INKmune product platforms.
Added
CORDStrom CORDStrom, developed by INmune Bio circa 2020, represents a breakthrough in mesenchymal stromal cell technology. The CORDStrom platform leverages, among other things, proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled human umbilical cord - derived mesenchymal stromal cells as medicines to treat complex inflammatory diseases.
Removed
We believe INKmune and XPro may be approvable under pathways that are potentially shorter than those typically available for drug products based on novel active ingredients, including as an orphan drug under the Orphan Drug Act and approval under the Food and Drug Administration (the “FDA”) Accelerated Approval Program (see the section entitled “Government Regulation”).
Added
It is caused by a fault in a gene that makes collagen, a protein that holds the skin layers together. There are limited options available for treatment, none that adequately meet the needs of patients, and the condition gets worse over time with many children reliant on a wheelchair as they move into their teenage years.
Removed
We have not yet had a discussion with the United Kingdom Medicines and Healthcare Products Regulatory Agency (“MHRA”) and/or FDA regarding such designation, but plan to do so in the future. We believe the INKmune program to treat castration resistant prostate cancer may qualify for orphan status.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeIn addition, later discovery of previously unknown problems with our products, manufacturing processes, or failure to comply with regulatory requirements, may lead to various adverse results, including: ● restrictions on such products, manufacturers or manufacturing processes; ● restrictions on the labeling or marketing of a product; ● restrictions on product distribution or use; 40 ● requirements to conduct post-marketing clinical trials; ● requirements to institute a risk evaluation mitigation strategy, or REMS, to monitor safety of the product post-approval; ● warning letters issued by the FDA or other regulatory authorities; ● withdrawal of the products from the market; ● refusal to approve pending applications or supplements to approved applications that we submit; ● recall of products, fines, restitution or disgorgement of profits or revenue; ● suspension, revocation or withdrawal of marketing approvals; ● refusal to permit the import or export of our products; and ● injunctions or the imposition of civil or criminal penalties.
Biggest changeLater discovery of previously unknown safety or efficacy issues, or failure to comply with regulatory obligations, could result in restrictions on manufacturing or distribution, labeling or marketing limitations, requirements for additional clinical trials or a Risk Evaluation and Mitigation Strategy (REMS), warning letters, fines, product recalls, withdrawal or suspension of approvals, import/export prohibitions, injunctions, or civil or criminal penalties.
In addition, the securities markets have from time-to-time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. These market fluctuations may also materially and adversely affect the market price of our Common Stock. 52 You may have difficulty trading and obtaining quotations for our common stock.
In addition, the securities markets have from time-to-time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. These market fluctuations may also materially and adversely affect the market price of our Common Stock. You may have difficulty trading and obtaining quotations for our common stock.
If we fail to protect our intellectual property rights, our ability to pursue the development of our technologies and products would be negatively affected. Our success will depend, in part, on our ability to obtain patents and maintain adequate protection of our technologies and products.
If we fail to protect our intellectual property rights, our ability to pursue the development of our technologies and products would be negatively affected. Our success depends in part on our ability to obtain and maintain adequate protection of our technologies and products.
You should carefully consider the risks described below as well as other information provided to you in this document, including information in the section of this document entitled “Information Regarding Forward Looking Statements.” If any of the following risks actually occur, the Company’s business, financial condition or results of operations could be materially adversely affected, the value of the Company’s Common Stock could decline, and you may lose all or part of your investment.
You should carefully consider the risks described below as well as other information provided to you in this document, including information in the section of this document entitled “Information Regarding Forward Looking Statements.” If any of the following risks actually occur, the Company’s business, financial condition or results of operations could be materially adversely affected, the value of the Company’s Common Stock could decline, and you may lose all or part of your investment. 37 RISKS RELATED TO OUR BUSINESS There is a Substantial Doubt About Our Ability to Continue as a Going Concern As of December 31, 2025, the Company had an accumulated deficit of $209,037,000.
Thus, there can be no assurance that our patent application will result in the issuance of a patent, that we will develop additional proprietary products that are patentable, that any patents issued to us will provide us with any competitive advantages or will not be challenged by any third parties, that the patents of others will not impede our ability to do business or that third parties will not be able to circumvent our patents.
There can be no assurance that any patent application will result in the issuance of a patent, that patents issued to us will provide a competitive advantage, that patents issued to others will not impede our business, or that third parties will not circumvent any patents we obtain.
Our securities are not actively traded, and the bid and asked prices for our common stock may fluctuate widely. As a result, investors may find it difficult to dispose of, or to obtain accurate quotations of the price of, our securities.
Our securities are not actively traded, and the bid and asked prices for our common stock may fluctuate significantly. As a result, investors may experience difficulty selling their shares or obtaining accurate quotations for the price of our securities.
If we are unable to achieve or sustain profitability or to meet outside expectations for our profitability, the value of our common stock will be materially and adversely affected.
If we are unable to achieve or sustain profitability, or if revenues from approved products are insufficient, our business, financial condition, and the value of our common stock will be materially and adversely affected.
Additional stock offerings in the future may dilute your percentage ownership of our company. Given our plans and expectations that we may need additional capital and personnel, we may need to issue additional shares of common stock or securities convertible or exercisable for shares of common stock, including convertible preferred stock, convertible notes, stock options or warrants.
To support our growth plans and capital requirements, we may need to issue additional shares of common stock or securities convertible or exercisable for common stock, including convertible preferred stock, convertible notes, stock options, or warrants. Any future issuance of such securities would dilute the ownership percentage of current stockholders.
However, as a smaller reporting company and a non-accelerated filer, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal control over financial reporting pursuant to Section 404 for as long as we are not deemed an “accelerated filer” or “large accelerated filer.” The rules governing the standards that must be met for our management to assess our internal control over financial reporting are complex and require significant documentation, testing and possible remediation.
As a smaller reporting company and a non-accelerated filer, our independent registered public accounting firm is not required to attest to the effectiveness of our internal controls under Section 404 for as long as we do not qualify as an “accelerated filer” or “large accelerated filer.” The standards for assessing internal controls are complex and require substantial documentation, testing, and, if necessary, remediation.
We are a public reporting company and, accordingly, subject to the information and reporting requirements of the Exchange Act and other federal securities laws, including compliance with the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”).
Compliance with federal securities laws and reporting requirements is costly and may divert resources from growth initiatives. As a public company, we are subject to the reporting and disclosure obligations of the Securities Exchange Act of 1934 (the “Exchange Act”) and other federal securities laws, including the Sarbanes-Oxley Act of 2002.
Our internal control over financial reporting may not meet the standards required by Section 404 of the Sarbanes-Oxley Act, and failure to achieve and maintain effective internal control over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act, could have a material adverse effect on our business and share price.
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. Management is required to assess and report on the effectiveness of our internal control over financial reporting.
If we breach this Agreement, Xencor may be able to terminate it, which would harm our business. Our officers and Chairman of the Board own the company that we license our INKmune patent from. On October 29, 2015, we entered into an exclusive license agreement with Immune Ventures, LLC (Immune Ventures).
If we breach this Agreement, Xencor may be able to terminate it, which would harm our business. 51 Potential conflict of interest with our INKmune license. On October 29, 2015, we entered into an exclusive license agreement with Immune Ventures, LLC (“Immune Ventures”) for our natural killer cell program, INKmune.
Failure to achieve and maintain an effective internal control environment could have a material adverse effect on our business, financial condition and results of operations and could limit our ability to report our financial results accurately and in a timely manner. Anti-takeover provisions in our stockholder rights plan could make a third-party acquisition of us difficult.
Failure to establish and maintain effective internal controls could materially harm our business, financial condition, and results of operations, and could impair our ability to report financial results accurately and on a timely basis. Anti-takeover provisions in our stockholder rights plan could make a third-party acquisition more difficult. We have a stockholder rights plan designed to discourage unsolicited takeover proposals.
The theft, destruction, loss, misappropriation, or release of sensitive and/or confidential information or intellectual property, or interference with our information technology systems or the technology systems of third parties on which we rely, could result in business disruption, negative publicity, brand damage, violation of privacy laws, loss of customers, potential liability and competitive disadvantage.
Theft, destruction, loss, misappropriation, or unauthorized disclosure of sensitive or confidential information, or interference with our information technology systems—or the systems of third parties on which we rely—could result in business disruption, negative publicity, reputational harm, violations of privacy laws, loss of customers, potential liability, and competitive disadvantage. 47 Use of Social Media Platforms Presents New Risks We believe that our potential patient population is active on social media.
Furthermore, there can be no assurance that others will not independently develop similar products, duplicate any of our products not under patent protection, or, if patents are issued to us, design around the patented products we developed or will develop. We may be required to obtain licenses from third parties to avoid infringing patents or other proprietary rights.
Others may independently develop similar products or duplicate products not under patent protection, or design around our patents. 49 We may need to obtain licenses from third parties to avoid infringing their patents or proprietary rights. There can be no assurance that such licenses would be available on acceptable terms, or at all.
Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading “Risk Factors” and should be carefully considered, together with other information in this Form 10-K and our other filings with the SEC, before making an investment decision regarding our common stock. ● We will require additional capital to finance our operations to continue as a going concern, which may not be available to us on acceptable terms, if at all.
Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading “Risk Factors” and should be carefully considered, together with other information in this Form 10-K and our other filings with the SEC, before making an investment decision regarding our common stock. ● There is a Substantial Doubt About Our Ability to Continue as a Going Concern. ● We Have a History of Losses and May Never Achieve or Sustain Profitability. ● Limitations on Capital Raising Due to Low Public Float. ● We face intense competition in the markets targeted by our product candidates.
In addition, our employees or third parties with whom we contract, such as our CROs or CMOs, may knowingly or inadvertently make use of social media in a manner that may give rise to liability, lead to the loss of trade secrets or other intellectual property or result in public exposure of personal information of our employees, clinical trial patients, customers and others or information regarding our product candidates or clinical trials.
In addition, our employees or third parties with whom we contract, including contract research organizations (“CROs”) or contract manufacturing organizations (“CMOs”), could knowingly or inadvertently use social media in a manner that exposes us to liability, compromises trade secrets or other intellectual property, or publicly discloses personal information of employees, clinical trial patients, customers, or information regarding our product candidates or clinical trials.
Our business involves the storage and transmission of numerous classes of sensitive and/or confidential information and intellectual property, including information relating to suppliers, private information about employees, and financial and strategic information about us and our business partners.
Our business involves the storage and transmission of sensitive and/or confidential information and intellectual property, including data relating to suppliers, private employee information, and financial and strategic information about us and our business partners. If we fail to adequately assess and manage cybersecurity risks, we may become increasingly vulnerable to such threats.
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.
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.
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. We expect that our product candidates under development, if approved, will face intense competition from existing and future drugs marketed by large companies.
We face intense competition in the markets targeted by our product candidates. Many competitors have substantially greater resources, and all of our product candidates are expected to face strong competition from existing and future drugs. If approved, our product candidates may compete with drugs marketed by large pharmaceutical and biotechnology companies.
In addition, we could incur substantial costs in defending ourselves in suits brought against us on patents it might infringe or in filing suits against others to have such patents declared invalid. Much of our know-how and technology may not be patentable. To protect our rights, we plan to require employees, consultants, advisors and collaborators to enter into confidentiality agreements.
We may also incur substantial costs defending against patent infringement claims or in challenging the validity of patents held by others. Much of our proprietary know-how and technology may not be patentable. To protect our rights, we require employees, consultants, advisors, and collaborators to enter into confidentiality and nondisclosure agreements.
We are exposed to risks related to currency exchange rates. We conduct a significant portion of our operations outside of the United States.
The scope, duration, and impact of any future health-related disruptions are uncertain and could materially and adversely affect our business, financial condition, and results of operations. We are exposed to risks related to currency exchange rates. We conduct a significant portion of our operations outside of the United States.
If we lose any of our right to use third-party intellectual property, it could adversely affect our ability to commercialize our technologies, products or services, as well as harm our competitive business position and our business prospects. We are dependent on our licensing agreement with Xencor, and the termination of this agreement would harm our business.
Additionally, if any licensor terminates a license or otherwise limits our rights, we could lose the ability to use important technologies or products, which could adversely affect our commercialization efforts, competitiveness, and overall business prospects. We are dependent on our licensing agreement with Xencor, and the termination of this agreement would harm 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.
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.
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.
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. We cannot market or sell any product candidate in the United States without FDA approval, nor in other jurisdictions without comparable regulatory authorizations.
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. Our business and results of operations could be adversely affected by changes in national or global economic conditions.
If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for CORDStrom, we may not be able to commercialize, or may be delayed in commercializing, CORDStrom and our ability to generate revenue could be materially impaired. 46 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.
Some of these technologies, applications or patents may conflict with our technologies or patent applications. Such conflict could limit the scope of the patents, if any, that we may be able to obtain or result in the denial of our patent applications.
Conflicts with these existing or future patents could limit the scope of patents we may obtain or result in the denial of our patent applications. If we cannot obtain required licenses or develop alternative technologies, product development or commercialization may be delayed or prohibited.
We have a stockholder rights plan that may have the effect of discouraging unsolicited takeover proposals. Specifically, the rights issued under the stockholder rights plan could cause significant dilution to a person or group that attempts to acquire us on terms not approved in advance by our board of directors.
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. The plan is not intended to prevent a takeover outright.
In addition, Xencor is required to indemnify us as to any breach of its representations, warranties and covenants made in the agreement. Further, our rights to current or future in-licensed patents and patent applications may be dependent, in part, on inter-institutional or other operating agreements between the joint owners of such in-licensed patents and patent applications.
Xencor has provided representations and warranties regarding its rights to grant licenses and is required to indemnify us against breaches of these representations, warranties, and covenants. Our rights to current and future in-licensed patents may also depend on inter-institutional or operating agreements among joint owners.
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. A pharmaceutical product cannot be marketed in the U.S. or other countries until we have completed rigorous and extensive regulatory review processes, including approval of a brand name.
Regulatory Approval of Product Brand Names Any pharmaceutical product we develop cannot be marketed in the U.S. or other countries until it completes rigorous regulatory review processes, including approval of a brand name. All proposed brand names for our product candidates require FDA approval, regardless of whether we have obtained a trademark registration from the U.S.
These financial statements do not include any adjustments to reflect the possible future effect on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the outcome of these uncertainties.
The financial statements do not include adjustments that might result if we are unable to continue as a going concern, including the possible impact on the recoverability and classification of assets or the amounts and classifications of liabilities.
Any of these events could have a material and adverse effect on our operations and 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.
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. Any approved product, its manufacturing processes, labeling, promotional activities, and post-approval clinical data will be subject to continuing regulation by the FDA and other authorities.
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.
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.
In addition, the U.S. government has the right, under certain limited circumstances, to require us to grant exclusive, partially exclusive, or non-exclusive licenses to any of these inventions to a third party if it determines that: (1) adequate steps have not been taken to commercialize the invention; (2) government action is necessary to meet public health or safety needs; or (3) government action is necessary to meet requirements for public use under federal regulations (also referred to as march-in rights).
These regulations grant the U.S. government certain rights, including a non-exclusive, irrevocable license to use the inventions for governmental purposes, and the ability, under specific circumstances, to require us to grant licenses to third parties (referred to as “march-in rights”) if: 1. Adequate steps have not been taken to commercialize the invention; 2.
As a result, we are not and have never been profitable and have incurred losses in each period since our inception, resulting in substantial doubt in our ability to continue as a going concern. We reported a net loss of $42.1 million and $30.0 million for the years ended December 31, 2024 and 2023, respectively.
We Have a History of Losses and May Never Achieve or Sustain Profitability We have incurred losses since our inception in September 2015 and are not currently profitable. We reported net losses of $45.9 million and $42.1 million for the years ended December 31, 2025 and 2024, respectively.
If one or more of such joint owners breaches such inter-institutional or operating agreements, our rights to such in-licensed patents and patent applications may be adversely affected. Any of these events could have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.
If any joint owner breaches such agreements, our rights to these patents and patent applications could be adversely affected. Any of these events could materially harm our competitive position, business, financial condition, results of operations, and prospects. 50 Risks related to government-funded intellectual property.
Patent protection and other intellectual property protection is crucial to the success of our business and prospects, and there is a substantial risk that such protections will prove inadequate. By working with research collaborators patent rights may be jointly owned by different parties.
There can be no assurance that our patents, licenses, or other intellectual property protections will provide meaningful protection, and failure to adequately protect our intellectual property could materially harm our business, prospects, and competitive position. By working with research collaborators patent rights may be jointly owned by different parties .
The license agreement relates to our natural killer program, INKmune. Immune Ventures is owned by our RJ Tesi, our CEO and Chairman of the Board of Directors, David Moss, our Chief Financial Officer and Treasurer and Mark Lowdell, our Chief Scientific Officer.
Immune Ventures is owned by our Chief Executive Officer and Treasurer, David Moss, our Chief Scientific Officer, Mark Lowdell, and our former CEO and former Chairman of the Board, RJ Tesi. Because our officers and former officers also own Immune Ventures, this relationship creates a potential conflict of interest.
We have paid no dividends on our common stock to date, and we do not anticipate paying any dividends to holders of our common stock in the foreseeable future.
We do not intend to pay dividends in the foreseeable future. We have not paid dividends on our common stock to date and do not expect to do so in the foreseeable future. Any future dividend decisions will depend on our operating results, financial condition, and capital requirements.
The patent positions of biotechnology, biopharmaceutical and pharmaceutical companies can be highly uncertain and involve complex legal and factual questions.
We have filed and are actively pursuing patent applications for our product candidates, but the patent positions of biotechnology, biopharmaceutical, and pharmaceutical companies are inherently uncertain and involve complex legal and factual questions.
This preference for U.S. industry may limit our ability to contract with non-U.S. product manufacturers for products covered by such intellectual property. 50 We license our patents from others. If such owners do not properly maintain or enforce the intellectual property underlying such licenses, our competitive position and business prospects could be harmed.
If such owners do not properly maintain or enforce the intellectual property underlying such licenses, our competitive position and business prospects could be harmed. Our licensors may also seek to terminate our license. We rely on licenses from third parties for certain intellectual property that is necessary or useful to our business.
The process of obtaining required approvals can be costly and time-consuming, and there can be no assurance that we develop successfully this product or any future products, or that this product or any future products we develop will prove to be safe and effective in clinical trials or receive applicable regulatory approvals.
Obtaining regulatory approvals is costly and time-consuming, and there is no assurance that any product will prove safe and effective or receive the necessary approvals. Investors should be aware that our business is subject to significant regulatory risks, delays, and expenses inherent in the development and commercialization of therapeutic products.
If we are unable to obtain or maintain sufficient insurance coverage at an acceptable cost or to otherwise protect against potential product liability claims, it could prevent or inhibit the development and commercial production and sale of our product candidate, which could adversely affect our business, financial condition, results of operations and prospects. 42 We will need to increase the size and capabilities of our organization, and we may experience difficulties in managing this growth.
If we are unable to obtain or maintain adequate insurance at reasonable cost, we could face significant financial exposure, which could materially and adversely affect our business, financial condition, results of operations, and prospects. We will need to expand our organization and may encounter challenges in managing this growth.
We may be eligible for priority review designation for our product candidate if the FDA determines such product candidate offers major advances in treatment or provides a treatment where no adequate therapy exists.
We may request priority review, but the FDA may not grant it, and even if granted, it may not accelerate approval. We may seek priority review for our product candidate if the FDA determines it offers a major advance in treatment or addresses a condition with no adequate therapy.
If sales by employees, executive officers, or directors cause a substantial number of our common shares to become available for purchase in the public market, the price of our common shares could fall or may not increase. Also, sales by such personnel could be viewed negatively by holders and potential purchasers of our common shares. 53
Such sales could increase the number of shares available in the public market, which may cause the trading price of our common stock to decline or prevent it from rising. In addition, sales by employees, executive officers, or directors could be perceived negatively by existing or potential investors, potentially affecting the market price of our common stock. 55
Certain of our licensors may have relied on third-party consultants or collaborators such that our licensors are not the sole and exclusive owners of the patents we in-licensed. If other third parties have ownership rights to our in-licensed patents, the license granted to us for such jointly owned patents may not be valid.
Some of our in-licensed patents may be jointly owned by multiple parties, including licensors, collaborators, or third-party consultants. If a third party holds ownership rights in patents we have licensed, the validity of our license could be uncertain.
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. We have never commercialized a product.
Even if our product candidates are approved, they may fail to achieve sufficient market acceptance, which could limit revenue and affect our business. We have never commercialized a product. Even if CORDStrom or any other product candidate is approved, physicians, patients, third-party payors, and others in the medical community may be reluctant to adopt new therapies.
If we do not adequately protect our intellectual property, competitors may be able to use our technologies to produce and market drugs in direct competition with us and erode our competitive advantage. Some foreign countries lack rules and methods for defending intellectual property rights and do not protect proprietary rights to the same extent as the United States.
If we fail to adequately protect our intellectual property, competitors may be able to use our technologies to develop and market products that compete directly with us, eroding our competitive advantage. Some foreign countries lack robust rules or enforcement mechanisms for intellectual property, which may make it difficult to protect our proprietary rights internationally.
In addition to patents, we rely on a combination of trade secrets, confidentiality, nondisclosure and other contractual provisions, and security measures to protect our confidential and proprietary information. These measures may not adequately protect our trade secrets or other proprietary information.
Furthermore, we may not be aware of all existing patents, published applications, or literature that could prevent the patentability of our products or limit the scope of our patent claims. Beyond patents, we rely on trade secrets, confidentiality agreements, nondisclosure provisions, and other contractual and security measures to protect proprietary information.
Initial success in clinical trials may not be indicative of results obtained when these trials are completed or in later-stage trials. The results of preclinical studies may not be predictive of the results of clinical trials, and the results of any early-stage clinical trials we commence may not be predictive of the results of the later-stage clinical trials.
Results from preclinical studies or early-stage clinical trials may not be predictive of outcomes in later-stage trials or final results. Initial success in a clinical trial, particularly in small early trials, may not indicate success in larger or later-stage studies.
The opinion of our independent registered public accounts on our audited financial statements for the year ended December 31, 2024, contains an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern. There is no assurance that we will be successful in raising the additional funds needed to fund our business plan.
Management intends to pursue additional funding and implement its strategic plan to support continuation of the Company, but there can be no assurance that these efforts will be successful. The opinion of our independent registered public accounting firm on our audited financial statements for the year ended December 31, 2025, includes an explanatory paragraph regarding this substantial doubt.
These factors raise substantial doubt about the Company’s ability to continue as a going concern for the 12 months from the issuance date of these financial statements.
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. These factors raise substantial doubt about our ability to continue as a going concern for the 12 months following the issuance of these financial statements.
Our success will depend in part on the ability of our licensors to obtain, maintain and enforce our licensed intellectual property.
Our licensors include Xencor, Inc., Immune Ventures, LLC, the University of Pittsburgh, and GOSH. Our business depends, in part, on the ability of these licensors to obtain, maintain, and enforce the intellectual property underlying our licenses.
Adverse pricing limitations may hinder our ability to recoup our investment in one or more product candidates, even if our product candidates obtain marketing approval. We are subject to various government regulations. The manufacture and sale of human therapeutic products in the U.S. and foreign jurisdictions are governed by a variety of statutes and regulations.
Consequently, we could face delays in product launches or limitations on revenues, which may hinder our ability to recoup development and commercialization costs. 39 We are subject to extensive government regulations. The manufacture and sale of human therapeutic products in the U.S. and abroad are governed by numerous laws and regulations.
Additionally, if a competitor receives FDA approval before we do for a drug that is similar to one of our product candidates, FDA approval for our product candidate may be precluded or delayed due to periods of non-patent exclusivity and/or the listing with the FDA by the competitor of patents covering its newly-approved drug product.
Competitors could market products more effectively, identify drug candidates or develop products faster, or produce therapies that are more effective, safer, or lower cost than ours. 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.
These laws require approval of manufacturing facilities, controlled research and testing of products and government review and approval of a submission containing manufacturing, preclinical and clinical data in order to obtain marketing approval based on establishing the safety and efficacy of the product for each use sought, including adherence to current cGMP during production and storage, and control of marketing activities, including advertising and labeling.
These requirements include approval of manufacturing facilities, controlled preclinical and clinical testing, submission of extensive data on safety and efficacy, compliance with current Good Manufacturing Practices (cGMP) during production and storage, and oversight of marketing activities, including advertising and labeling. The products we are developing require substantial investment, development, and testing before commercialization.
If we fail to effectively assess and identify cybersecurity risks associated with the use of technology in our business operations, we may become increasingly vulnerable to such risks. Additionally, while we have implemented measures to prevent security breaches and cyber incidents, our preventative measures and incident response efforts may not be entirely effective.
Although we have implemented measures to prevent security breaches and cyber incidents, these measures and our incident response efforts may not be entirely effective.
If the U.S. government exercised its march-in rights in our current or future intellectual property rights that are generated through the use of U.S. government funding or grants, we could be forced to license or sublicense intellectual property developed by us or that we license on terms unfavorable to us, and there can be no assurance that we would receive compensation from the U.S. government for the exercise of such rights.
If the government exercised its march-in rights, we could be required to license or sublicense such intellectual property on terms unfavorable to us, without assurance of compensation. Additionally, government-funded inventions are generally required to be manufactured substantially in the United States.
If they do not adequately protect our rights, third parties could use our technology, and we could lose any competitive advantage we may have. In addition, others may independently develop similar proprietary information or techniques or otherwise gain access to our trade secrets, which could impair any competitive advantage we may have.
These measures may not fully prevent unauthorized use of our technology or disclosure of our proprietary information. Others may independently develop similar technologies or gain access to our trade secrets, which could diminish our competitive advantage.
The costs of advancing product candidates into each clinical phase tend to increase substantially over the duration of the clinical development process. Therefore, the total costs to advance any of our product candidates to marketing approval in even a single jurisdiction will be substantial.
The costs of clinical development increase substantially at each phase, and the total expenses to achieve marketing approval for any product candidate, even in a single jurisdiction, will be substantial. Due to the inherent risks and uncertainties of pharmaceutical product development, we cannot predict when, or if, we will generate revenue or achieve profitability.
The development and commercialization of new drug products is highly competitive. We expect that we will face significant competition from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide with respect to our DN-TNF product platform, INKmune and any other of our product candidates that we may seek to develop or commercialize in the future.
We expect to face significant competition from major pharmaceutical companies, specialty pharmaceutical companies, and biotechnology companies worldwide with respect to any product candidates we may develop or commercialize. 43 Dependence on Key Personnel Our success depends largely on the continued service and performance of our principal members of management and scientific staff.
If we do not obtain such licenses, we could encounter delays in the introduction of products or could find that the development, manufacture or sale of products requiring such licenses could be prohibited. 48 A number of pharmaceutical, biopharmaceutical and biotechnology companies and research and academic institutions have developed technologies, filed patent applications or received patents on various technologies that may be related to or affect our business.
Failure to obtain necessary licenses could delay or prevent the development, manufacture, or commercialization of our product candidates. A number of companies, academic institutions, and research organizations have filed patents or developed technologies that may relate to or affect our business.
The rights plan is not intended to prevent a takeover, and we believe it will enable all our stockholders to realize the full potential value of their investment in the Company and protect the Company and its stockholders from efforts to obtain control of the Company that are inconsistent with the best interests of the Company and its stockholders.
We believe it helps stockholders realize the full potential value of their investment and protects the Company and its stockholders from attempts to gain control in ways inconsistent with their best interests. The rights under the plan are set to expire on December 30, 2026, unless extended or otherwise modified as permitted under the terms of the plan.
There can be no assurance that we will be able to develop internal sales, marketing distribution capabilities or establish or maintain relationships with third-party collaborators to commercialize any product in the United States or overseas. We face substantial competition from other pharmaceutical and biotechnology companies and our operating results may suffer if we fail to compete effectively.
Any failure to develop internal capabilities or establish successful third-party arrangements could materially and adversely affect our ability to generate revenue from our product candidates. We face substantial competition from other pharmaceutical and biotechnology companies and our operating results may suffer if we fail to compete effectively. The development and commercialization of new drug products is highly competitive.
If we obtain regulatory approvals, CORDStrom, INKmune and/or the DN-TNF product platform, and the manufacturing facilities used for its production will be subject to continual review, including periodic inspections, by the FDA and other United States and foreign regulatory authorities.
Even if we obtain regulatory approvals for CORDStrom or any product, ongoing regulation may limit our ability to manufacture and commercialize these products. Approved products and the facilities used to manufacture them will remain subject to continuous review and inspections by the FDA and other U.S. and foreign regulatory authorities.
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.
Unforeseen events in clinical trials could delay or prevent marketing approval of our product candidates. We may experience a variety of challenges during clinical trials that could adversely affect the development and approval of our product candidates.
We do not have any insurance for liabilities arising from medical or hazardous materials. Compliance with applicable environmental laws and regulations is expensive, and current or future environmental regulations may impair our research, development and production efforts, which could harm our business, prospects, financial condition or results of operations.
Accidents could result in liability for damages, fines, or restrictions on our operations, and we currently have no insurance coverage for such liabilities. Compliance with environmental and safety regulations is costly, and changes in such regulations could impair our research, development, or production efforts, adversely affecting our business, financial condition, and results of operations.
Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts.
We face inherent risks of product liability claims as a result of clinical testing of our product candidates, and these risks would increase if we commercialize any products. Claims could be based on alleged defects in design or manufacturing, failure to warn of risks, negligence, strict liability, breach of warranties, or violations of consumer protection laws.
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.
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. We engage contract research organizations, investigators, and other third parties to conduct our clinical trials, manage data, and provide related services.
The commercial success of our product candidates will depend substantially, both domestically and abroad, on the extent to which the costs of our product candidates will be paid by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or reimbursed by government health administration authorities (such as Medicare and Medicaid), private health coverage insurers and other third-party payors.
Even if we commercialize our product candidates, pricing, reimbursement, and healthcare regulations could limit their market success. The commercial success of our products will depend largely on coverage and reimbursement by government programs (such as Medicare and Medicaid), private insurers, and other third-party payors, both in the U.S. and abroad.
The widespread use of technology, including mobile devices, cloud computing, and the internet, gives rise to cybersecurity risks, including security breach, espionage, system disruption, theft and inadvertent release of information.
Cybersecurity Incidents and Other Technological Disruptions Could Negatively Affect Our Business and Customer Relationships 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.
Our success will depend, in part, on our ability to obtain patents, maintain trade secret protection and operate without infringing on the proprietary rights of third parties or having third parties circumvent our rights. We have filed and are actively pursuing a patent application for our product candidates.
Risks Related to our Intellectual Property We depend on obtaining certain patents and protecting our proprietary rights. Our success depends in part on our ability to obtain and maintain patents, protect trade secrets, and operate without infringing the proprietary rights of others.
It is impossible to predict when or if our product candidates will prove effective or safe in humans or will receive regulatory approval. Before obtaining marketing approval from regulatory authorities for the sale of any product candidate, we must complete preclinical development and then conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidate in humans.
Our product candidates are in early stages of development, and the risk of failure is high. Before obtaining marketing approval, we must complete preclinical studies and extensive clinical trials to demonstrate safety and efficacy. Clinical development is time-consuming, costly, and uncertain, and a failure can occur at any stage.
There is no assurance that our competitors will not develop more effective or more affordable products, or achieve earlier patent protection or product commercialization, than our own.
There is no assurance that our competitors will not develop more effective or affordable products, secure earlier approvals, or achieve earlier commercialization. Even as we seek to expand our technological capabilities, research by others may render our products less competitive, obsolete, or inferior to alternative therapies.
Certain in-licensed patents (i.e. those from the University of Pittsburgh) were supported through the use of U.S. government funding. Pursuant to the Bayh-Dole Act of 1980, the U.S. government has certain rights in inventions developed with government funding. These U.S. government rights include a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose.
Some of our in-licensed patents, including certain rights from the University of Pittsburgh, were developed with U.S. government funding and are therefore subject to federal regulations under the Bayh-Dole Act of 1980.
There can be no assurance, however, that these agreements will provide meaningful protection for our trade secrets, know-how or other proprietary information in the event of any unauthorized use or disclosure. Further, our business may be adversely affected by competitors who independently develop competing technologies, especially if we obtain no, or only narrow, patent protection.
However, these agreements may not provide meaningful protection in the event of unauthorized use or disclosure. Competitors may independently develop competing technologies, particularly if patent protection is narrow or unavailable, which could erode our competitive advantage and harm our business prospects.
This severely limits the liquidity of the common stock and would likely reduce the market price of our common stock and hamper our ability to raise additional capital. There is a limited market for our securities. Accordingly, investors may therefore bear the economic risk of an investment in our securities for an indefinite period of time.
Given the limited market for our securities, investors may bear the economic risk of an investment in our shares for an indefinite period of time. 54 Additional stock offerings in the future may dilute your ownership interest in our company.
Public health threats, such as the novel coronavirus (COVID-19), influenza and other highly communicable diseases or viruses could adversely impact our operations and disrupt our ongoing or planned research and development activities.
Public health emergencies, including pandemics, epidemics, or other outbreaks of highly communicable diseases, could disrupt our business operations and delay or impair our research and development activities.
For example, patients may use social media platforms to comment on the effectiveness of, or adverse experiences with, a product candidate, which could result in reporting obligations. In addition, there is a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments about us or our product candidates on any social networking website.
There is also a risk that sensitive information could be disclosed inappropriately, or that negative or inaccurate posts about us or our product candidates may appear on social media.
In accordance with the guidelines specified under Rule 10b5-1 under the Exchange Act, as amended, equivalent legislation in applicable jurisdictions, and our policies regarding equity transactions, a number of our employees, including executive officers, may adopt share trading plans pursuant to which they have arranged to sell common shares from time to time in the future.
Some of our employees, including executive officers, may adopt trading plans under Rule 10b5-1 of the Exchange Act, equivalent laws in other jurisdictions, or our internal equity policies, allowing them to sell common stock at predetermined times. Sales of common stock, including under these plans, generally require public filings.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeWe engage an external party to enhance our cybersecurity oversight. Governance Our Audit Committee of the Board of Directors, or the Audit Committee, is responsible for overseeing cybersecurity risk and periodically updates our Board of Directors on such matters.
Biggest changeWe engage an external party to enhance our cybersecurity oversight. For more information about these risks, please refer to the section entitled “Risk Factors” in this Annual Report on Form 10-K. Governance Our Audit Committee of the Board of Directors, or the Audit Committee, is responsible for overseeing cybersecurity risk and periodically updates our Board of Directors on such matters.
Our Chief Financial Officer is responsible for the operational oversight of company-wide cybersecurity strategy, policy, and standards across relevant departments to assess and help prepare us to address cybersecurity risks.
Our Chief Executive Officer is responsible for the operational oversight of company-wide cybersecurity strategy, policy, and standards across relevant departments to assess and help prepare us to address cybersecurity risks.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeITEM 2. PROPERTIES The Company leases approximately 5,000 square feet of office space in Boca Raton, Florida from a third-party, which serves as the headquarters of the Company. We currently pay approximately $16,000 per month for this lease which expires in March 2027. We believe our current facilities are suitable and adequate to meet our current needs.
Biggest changeITEM 2. PROPERTIES The Company leases approximately 5,000 square feet of office space in Boca Raton, Florida from a third-party, which serves as the headquarters of the Company. We currently pay approximately $16,000 per month for this lease which expires in March 2027.
Added
The Company’s wholly-owned subsidiary, INmune Bio International Ltd leases manufacturing space in the United Kingdom pursuant to a 2-year collaboration agreement in which the Company is required to pay 225,000 pounds for manufacturing space in the first year and 450,000 pounds in the second year. The Company occupies 184 square meters for the production of CORDStrom.
Added
We believe our current facilities are suitable and adequate to meet our current needs.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeAs of December 31, 2024, there were 28 holders of record of our common stock. Because shares of our common stock are held by depositories, brokers and other nominees, the number of beneficial holders of our shares is substantially larger than the number of record holders.
Biggest changeAs of December 31, 2025, there were 28 holders of record of our common stock. Because shares of our common stock are held by depositories, brokers and other nominees, the number of beneficial holders of our shares is substantially larger than the number of record holders.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeIn the future, we may develop the asset in a wide variety of therapeutic areas, with a variety of delivery techniques by ourselves or in conjunction with partners. 63 Results of Operations Comparison of the Years Ended December 31, 2024 and December 31, 2023 Year Ended (in thousands) December 31, 2024 December 31, 2023 Change Revenues $ 14 $ 155 $ (141 ) General and Administrative 9,483 9,623 (140 ) Research and Development 33,166 20,273 12,893 Other (Income) Expense, net (553 ) 267 (820 ) Net loss $ 42,082 $ 30,008 $ 12,074 Revenues During 2024 and 2023, the Company sold MSC’s to one customer in the United Kingdom and recognized $14,000 and $155,000 of revenues, respectively.
Biggest changeIn the future, we may develop the asset in a wide variety of therapeutic areas, with a variety of delivery techniques by ourselves or in conjunction with partners. 62 Results of Operations Comparison of the Years Ended December 31, 2025 and 2024 Year Ended (in thousands) December 31, 2025 December 31, 2024 Change Revenues $ 50 $ 14 $ 36 General and Administrative 10,260 9,483 777 Research and Development 20,659 33,166 (12,507 ) Impairment of acquired in-process research and development intangible assets 16,514 - 16,514 Other Income, net (1,450 ) (553 ) (897 ) Net loss $ 45,933 $ 42,082 $ 3,851 Revenues During 2025 the Company recognized $50,000 of revenue in connection with a license agreement.
We anticipate that our expenses will increase substantially as we: ● continue research and development, including preclinical and clinical development of our existing product candidates; ● potentially seek regulatory approval for our product candidates; 61 ● seek to discover and develop additional product candidates; ● establish a commercialization infrastructure and scale up our manufacturing and distribution capabilities to commercialize any of our product candidates for which we may obtain regulatory approval; ● seek to comply with regulatory standards and laws; ● maintain, leverage and expand our intellectual property portfolio; ● hire clinical, manufacturing, scientific and other personnel to support our product candidate’s development and future commercialization efforts; ● add operational, financial and management information systems and personnel; and ● incur additional legal, accounting and other expenses in operating as a public company.
We anticipate that our expenses will increase substantially as we: ● continue research and development, including preclinical and clinical development of our existing product candidates; ● potentially seek regulatory approval for our product candidates; ● seek to discover and develop additional product candidates; ● establish a commercialization infrastructure and scale up our manufacturing and distribution capabilities to commercialize any of our product candidates for which we may obtain regulatory approval; ● seek to comply with regulatory standards and laws; ● maintain, leverage and expand our intellectual property portfolio; ● hire clinical, manufacturing, scientific and other personnel to support our product candidate’s development and future commercialization efforts; ● add operational, financial and management information systems and personnel; and ● incur additional legal, accounting and other expenses in operating as a public company.
The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues, if any. 59 Our recurring net losses and negative cash flows from operations raise substantial doubt regarding our ability to continue as a going concern within one year after the issuance of our consolidated financial statements for the year ended December 31, 2024.
The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues, if any. 58 Our recurring net losses and negative cash flows from operations raise substantial doubt regarding our ability to continue as a going concern within one year after the issuance of our consolidated financial statements for the year ended December 31, 2025.
The Australian research and development tax incentive is recognized when there is reasonable assurance that the incentive will be received, the relevant expenditure has been incurred and the amount of the consideration can be reliably measured. 60 Substantially all of our research and development expenses to date have been incurred in connection with our current and future product candidates.
The United Kingdom research and development tax incentive is recognized when there is reasonable assurance that the incentive will be received, the relevant expenditure has been incurred and the amount of the consideration can be reliably measured. Substantially all of our research and development expenses to date have been incurred in connection with our current and future product candidates.
Our cash and cash equivalents were $20.9 million and total current assets were $22.7 million at December 31, 2024, which the Company is projecting will be insufficient to sustain its operations through one year following the date that the financial statements are issued. Additional capital may not be available on reasonable terms, if at all.
Our cash and cash equivalents were $24.8 million and total current assets were $29.9 million at December 31, 2025, which the Company is projecting will be insufficient to sustain its operations through one year following the date that the financial statements are issued. Additional capital may not be available on reasonable terms, if at all.
We participate, through our wholly owned subsidiary in Australia, in the Australian research and development tax incentive program, such that a percentage of our qualifying research and development expenditures are reimbursed by the Australian government, and such incentives are reflected as a reduction of research and development expense.
We participate, through our wholly owned subsidiary in the United Kingdom, in the research and development program provided by the United Kingdom tax relief program, such that a percentage of our qualifying research and development expenditures are reimbursed by the United Kingdom government, and such incentives are reflected as a reduction of research and development expense.
Licensing and Collaboration Agreements We anticipate that in-licensing, out-licensing and strategic collaborations will become an integral part of our operations, providing the company with opportunities to leverage our partners’ expertise and capabilities to further expand the potential of our technologies, product candidates and revenue streams. Xencor In October 2017, we licensed INB03 (also known as XPro) from Xencor.
Licensing and Collaboration Agreements We anticipate that in-licensing, out-licensing and strategic collaborations will become an integral part of our operations, providing the company with opportunities to leverage our partners’ expertise and capabilities to further expand the potential of our technologies, product candidates and revenue streams.
Our research and development expense primarily consist of: ● clinical trial and regulatory-related costs; ● expenses incurred under agreements with investigative sites and consultants that conduct our clinical trials; ● manufacturing and testing costs and related supplies and materials; and ● employee-related expenses, including salaries, benefits, travel and stock-based compensation The following table summarizes our research and development expenses by product candidate for the periods indicated (in thousands): Year Ended December 31, 2024 2023 External Costs DN-TNF – Alzheimer’s disease $ 23,765 $ 13,817 INKmune (High Risk MDS/AML & Prostate Cancer) and CORDStrom 4,589 3,296 Preclinical and other programs 611 921 Accrued research and development rebate (1,823 ) (3,040 ) Total external costs 27,142 14,994 Internal Costs 6,024 5,279 $ 33,166 $ 20,273 We typically use our employee resources across our development programs.
Our research and development expense primarily consist of: ● clinical trial and regulatory-related costs; ● expenses incurred under agreements with investigative sites and consultants that conduct our clinical trials; ● manufacturing and testing costs and related supplies and materials; and ● employee-related expenses, including salaries, benefits, travel and stock-based compensation The following table summarizes our research and development expenses by product candidate for the periods indicated (in thousands): Year Ended December 31, 2025 2024 External Costs DN-TNF – Alzheimer’s disease $ 10,026 $ 23,765 INKmune (Prostate Cancer) and CORDStrom 5,547 4,589 Preclinical and other programs 141 611 Accrued research and development rebate (2,919 ) (1,823 ) Total external costs 12,795 27,142 Internal Costs 7,864 6,024 $ 20,659 $ 33,166 We typically use our employee resources across our development programs.
The change in our net operating assets and liabilities was primarily due to a decrease in prepaid expenses of $1.2 million, a decrease in research and development tax rebate receivable of $0.7 million and a decrease in other tax receivable of $0.3 million, partially offset by a decrease of $1.4 in accounts payable and accrued liabilities.
The change in our net operating assets and liabilities was primarily due to an increase in research and development tax rebate receivable of $3.1 million, a decrease in deferred liabilities of $0.5 million and a decrease in other assets of $0.5 million, partially offset by a decrease of $1.9 million in accounts payable and accrued liabilities.
Net Cash Provided by Financing Activities During the years ended December 31, 2024 and 2023, the Company paid off $10.0 million and $5.0 million, respectively, of its debt. During the year ended December 31, 2024, the Company sold 247,126 shares of its common stock for net proceeds of $2.4 million under the Company’s ATM program.
During the year ended December 31, 2024, the Company paid off $10.0 million of its debt. During the year ended December 31, 2024, the Company sold 247,126 shares of its common stock for net proceeds of $2.4 million under the Company’s ATM program.
General and Administrative Expenses General and administrative expenses consist principally of payroll and personnel expenses, including stock-based compensation; professional fees for legal, consulting, accounting and tax services; insurance, overhead, including rent and utilities; and other general operating expenses not otherwise classified as research and development expenses.
General and Administrative Expenses General and administrative expenses consist principally of payroll and personnel expenses, including stock-based compensation; professional fees for legal, consulting, accounting and tax services; insurance, overhead, including rent and utilities; and other general operating expenses not otherwise classified as research and development expenses. 61 Other income, net Other expense consists primarily of interest income on money market investments.
Any of these events could significantly harm our business, financial condition and prospects. ATM Sales Agreement During the year ending December 31, 2024, the Company sold 247,126 shares of common stock at an average price of $9.85 for gross proceeds of approximately $2.4 million under the at the market offerings.
Any of these events could significantly harm our business, financial condition and prospects. 64 ATM Sales Agreement During the year ending December 31, 2025, the Company sold 1,304,707 shares of common stock at an average price of $8.01 for gross proceeds of approximately $10.4 million under the at-the-market offerings.
Research and Development Research and development expenses increased to $33.2 million for the year ended December 31, 2024 from $20.3 million for the year ended December 31, 2023.
Research and Development Research and development expenses decreased to $20.7 million for the year ended December 31, 2025 from $33.2 million for the year ended December 31, 2024.
The costs of clinical trials may vary significantly over the life of a project owing to, but not limited to, the following: ● per patient trial costs; ● the number of sites included in the clinical trials; ● the countries in which the clinical trials are conducted; ● the length of time required to enroll eligible patients; ● the number of patients that participate in the clinical trials; ● the number of doses that patients receive; ● the cost of comparative agents used in clinical trials; ● the drop-out or discontinuation rates of patients; ● potential additional safety monitoring or other studies requested by regulatory agencies; ● the duration of patient follow-up; ● the efficacy and safety profile of the product candidate; and ● the cost of manufacturing, finishing, labeling and storage drug used in the clinical trial We do not expect any of our product candidates to be commercially available for at least the next several years, if ever.
The costs of clinical trials may vary significantly over the life of a project owing to, but not limited to, the following: ● per patient trial costs; ● the number of sites included in the clinical trials; ● the countries in which the clinical trials are conducted; ● the length of time required to enroll eligible patients; ● the number of patients that participate in the clinical trials; ● the number of doses that patients receive; ● the cost of comparative agents used in clinical trials; ● the drop-out or discontinuation rates of patients; ● potential additional safety monitoring or other studies requested by regulatory agencies; ● the duration of patient follow-up; ● the efficacy and safety profile of the product candidate; and ● the cost of manufacturing, finishing, labeling and storage drug used in the clinical trial We intend to file an MAA for CORDStrom in the United Kingdom and the European Union, followed by a BLA with the FDA targeted for 2026.
The increase in research and development expenses during the year ended December 31, 2024 compared to 2023 is mainly due to the Company incurring $9.9 million higher costs with our Alzheimer’s clinical trial, $1.3 million of higher costs in connection with our INKmune/CORDStrom clinical trials, $0.7 million higher internal costs and $1.2 million lower accrued R&D rebate, partially offset by $0.3 million lower of preclinical and other expenses.
The decrease in research and development expenses during the year ended December 31, 2025 compared to 2024 is mainly due to the Company incurring $13.7 million lower costs with our Alzheimer’s clinical trial as a result of completing the Phase 2 trial in 2025, $1.1 million higher accrued rebate and $0.5 million lower preclinical and other expenses, partially offset by $1.8 million of higher internal costs, and $1.0 million higher costs in connection with our INKmune/CORDStrom products under development.
As of December 31, 2024, the cash balance held by our foreign subsidiaries with currencies other than the United States dollar was approximately $0.1 million. 64 Our recurring net losses and negative cash flows from operations, as well as forecast of continued losses and negative cash flows from operations, raised substantial doubt regarding our ability to continue as a going concern within one year after the issuance of our consolidated financial statements for the year ended December 31, 2024.
Our recurring net losses and negative cash flows from operations, as well as forecast of continued losses and negative cash flows from operations, raised substantial doubt regarding our ability to continue as a going concern within one year after the issuance of our consolidated financial statements for the year ended December 31, 2025.
Net cash used in operating activities was $33,361,000 and $11,980,000 for the years ended December 31, 2024 and 2023, respectively. Since inception, we have funded our operations primarily with proceeds from the sales of our common stock. As of December 31, 2024, we had cash and cash equivalents of $20,922,000.
We incurred a net loss of $45,933,000 and $42,082,000 for the years ended December 31, 2025 and 2024, respectively. Net cash used in operating activities was $22,582,000 and $33,361,000 for the years ended December 31, 2025 and 2024, respectively. Since inception, we have funded our operations primarily with proceeds from the sales of our common stock.
As of December 31, 2024 and 2023, we had cash and cash equivalents of $20.9 million and $35.8 million, respectively. We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase as we continue our research and development of, and seek regulatory approvals for, our product candidates.
We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase as we continue our research and development of, and seek regulatory approvals for, our product candidates.
Other income, net Other expense consists primarily of interest expense incurred on debt, partially offset by interest income from a money market investment. Critical Accounting Estimates This management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which we have prepared in accordance with accounting principles generally accepted in the United States.
In addition, other income includes interest expense incurred on debt, if any, and other items such as gain on forgiveness of payables. Critical Accounting Estimates This management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which we have prepared in accordance with accounting principles generally accepted in the United States.
We discuss factors that we believe could cause or contribute to these differences below and elsewhere in this Form 10-K, including those set forth under “Risk Factors” and “Forward-Looking Statements.” Overview Our objective is to develop and commercialize our product candidates to treat diseases where the innate immune system is dysfunctional causing or contributing to the patient’s disease.
We discuss factors that we believe could cause or contribute to these differences below and elsewhere in this Form 10-K, including those set forth under “Risk Factors” and “Forward-Looking Statements.” 57 Overview INmune Bio is a clinical-stage biotechnology company dedicated to developing and commercializing a pipeline of product candidates designed to reprogram the innate immune system.
Operating activities used $12.0 million of cash for the year ended December 31, 2023, primarily resulting from our net loss of $30.0 million, partially offset by a net cash inflow of $10.4 million for changes in our net operating assets and liabilities, and non-cash stock-based compensation charges of $7.4 million.
Operating activities used $22.6 million of cash for the year ended December 31, 2025, primarily resulting from our net loss of $45.9 million, $2.5 million of changes in our net operating assets and liabilities and $0.6 million of gain on payables, partially offset by $16.5 million of intangible impairment expense, and $9.9 million of non-cash stock-based compensation expense.
During February 2025, the Company entered into a letter agreement with its lenders whereby its term loan was terminated. 65 Cash Flows The following table provides information regarding our cash flows for the years ended December 31, 2024 and 2023: Year Ended December 31, 2024 2023 Net cash used in operating activities $ (33,361 ) $ (11,980 ) Net cash used in (provided by) financing activities 18,211 (4,225 ) Impact on cash from foreign currency translation 224 (100 ) Net decrease in cash and cash equivalents $ (14,926 ) $ (16,305 ) Net Cash Used in Operating Activities Our cash used in operating activities was primarily driven by our net loss.
Cash Flows The following table provides information regarding our cash flows for the years ended December 31, 2025 and 2024: Year Ended December 31, (in thousands) 2025 2024 Net cash used in operating activities $ (22,582 ) $ (33,361 ) Net cash used in investing activities (1,042 ) - Net cash provided by financing activities 27,612 18,211 Impact on cash from foreign currency translation (159 ) 224 Net increase (decrease) in cash and cash equivalents $ 3,829 $ (14,926 ) Net Cash Used in Operating Activities Our cash used in operating activities was primarily driven by our net loss.
During the year ended December 31, 2023, the Company sold 75,697 shares of its common stock for net proceeds of $0.8 million under the Company’s ATM program.
Net Cash Provided by Financing Activities During the year ended December 31, 2025, the Company sold 1,304,707 shares of common stock under its ATM program for net proceeds of $10.1 million.
Directors and officers that participated in the offering paid a combined offering price of $8.445 per share and warrant, and other investors paid $8.32 per share and warrant. During the year ended December 31, 2024, the Company received $0.4 million in exchange for the exercise of 108,000 stock options.
During the year ended December 31, 2024, the Company received $0.4 million in exchange for the exercise of 108,000 stock options.
As a result, we are not and have never been profitable and have incurred losses in each period since our inception, resulting in substantial doubt in our ability to continue as a going concern. We reported a net loss of $42.1 million and $30.0 million for the years ended December 31, 2024 and 2023, respectively.
We continue to incur significant development and other expenses related to our ongoing operations. As a result, we are not and have never been profitable and have incurred losses in each period since our inception, resulting in substantial doubt in our ability to continue as a going concern.
The change in our net operating assets and liabilities was primarily due to a decrease in research and development tax credit receivable of $6.2 million, a decrease in prepaid expenses and other current assets of $2.5 million and an increase in accounts payable and accrued liabilities of $2.7 million, partially offset by a decrease in accrued liability – long term of $0.6 million.
The change in our net operating assets and liabilities was primarily due to a decrease in prepaid expenses of $1.2 million, a decrease in research and development tax rebate receivable of $0.7 million and a decrease in other tax receivable of $0.3 million, partially offset by a decrease of $1.4 million in accounts payable and accrued liabilities. 65 Net Used in Investing Activities During the year ended December 31, 2025, the Company purchased $1.0 million of equipment to be used in connection with its CORDStrom clinical program.
Registered Direct Offerings During September 2024, the Company entered into securities purchase agreements with investors whereby the Company sold 2,341,260 shares of the Company’s common stock and warrants to purchase an additional 2,341,260 shares of the Company’s common stock exercisable six months from the issuance date in a registered direct offering in exchange for gross proceeds of $13.0 million (net proceeds of approximately $12.0 million).
Registered Direct Offering During June 2025, the Company entered into securities purchase agreements with investors whereby the Company sold 3,000,000 shares of the common stock in a registered direct offering in exchange for gross proceeds of $18.9 million (net proceeds of approximately $17.4 million).
Off-Balance Sheet Arrangements During the periods presented, we did not have any off-balance sheet arrangements as defined under SEC rules.
The Company does not have any critical accounting estimates that are likely to have a material impact on our financial condition or results of operation. Off-Balance Sheet Arrangements During the periods presented, we did not have any off-balance sheet arrangements as defined under SEC rules.
Liquidity and Capital Resources Liquidity is the ability of a company to generate funds to support its current and future operations, satisfy its obligations and otherwise operate on an ongoing basis. We incurred a net loss of $42,082,000 and $30,008,000 for the years ended December 31, 2024 and 2023, respectively.
During 2024, the Company recognized $0.7 million of interest expense related to debt that was paid off during 2024. 63 Liquidity and Capital Resources Liquidity is the ability of a company to generate funds to support its current and future operations, satisfy its obligations and otherwise operate on an ongoing basis.
We track outsourced development costs by product candidate or development program, but we do not allocate internal costs personnel costs including salaries and stock-based compensation to specific product candidates or development programs.
We track outsourced development costs by product candidate or development program, but we do not allocate internal personnel costs including salaries and stock-based compensation to specific product candidates or development programs. 59 We participate, through our wholly owned subsidiary in Australia, in the Australian research and development tax incentive program, such that a percentage of our qualifying research and development expenditures are reimbursed by the Australian government, and such incentives are reflected as a reduction of research and development expense.
General and Administrative General and administrative expenses were $9.5 million for the year ended December 31, 2024, compared to $9.6 million for the year ended December 31, 2023. The decrease in general and administrative expenses is due to lower travel expense.
In 2024, the Company sold MSC’s to one customer in the United Kingdom and recognized $14,000 of revenues. General and Administrative General and administrative expenses were $10.3 million for the year ended December 31, 2025, compared to $9.5 million for the year ended December 31, 2024.
We currently do not hedge foreign currencies but will continue to assess whether that strategy is appropriate.
We currently do not hedge foreign currencies but will continue to assess whether that strategy is appropriate. As of December 31, 2025, the cash balance held by our foreign subsidiaries with currencies other than the United States dollar was approximately $0.2 million.
We have added CORDStrom, a pooled, human umbilical cord mesenchymal stem cell product to treat recessive dystrophic epidermolysis bullosa (RDEB), a pediatric orphan disease caused by mutations in the COL7A1 gene that results in a debilitating disease of skin blistering, dysphagia and failure to thrive with chronic wound problems that often results in fatal squamous cell carcinoma.
RDEB is a devastating pediatric orphan disease caused by mutations in the COL7A1 gene. This genetic deficiency leads to systemic complications, including highly debilitating skin blistering, chronic non-healing wounds, dysphagia, and failure to thrive. Over time, the chronic inflammatory environment associated with RDEB often progresses to fatal squamous cell carcinoma. RDEB is a systemic disease with no approved systemic treatments.
Removed
Innate immune dysfunction can occur for a variety of reasons including genetics, lifestyle, and other factors. However, age plays a significant role in the development of immune dysfunction. Innate immune dysfunction can be seen in cancer where Natural Killer (“NK”) cells are impaired and facilitate a tumor’s evasion of the immune system and subsequent disease progression.
Added
Our mission is to address a broad range of diseases where chronic inflammation and immune dysfunction are primary drivers of pathology. Lead Program: CORDStrom™ for RDEB Our primary focus is the treatment of Recessive Dystrophic Epidermolysis Bullosa (“RDEB”) using CORDStrom, our proprietary, pooled, human umbilical cord-derived mesenchymal stromal cell platform.
Removed
Chronic inflammation is implicated in neurologic and metabolic diseases where it impairs the innate immune system. Our primary focus continues to be treatment of cancer with INKmune and treatment of Alzheimer’s Disease (“AD”) and Treatment Resistant Depression (“TRD”) with XPro1595.
Added
The only approved products to date are topical and do not address the systemic issues of the disease, which is the focus of CORDStrom. CORDStrom has recently completed a pivotal, blinded, randomized cross-over trial. Based on these data, the Company is transitioning toward regulatory submission and commercialization.
Removed
XPro1595 (“XPro”), targets Alzheimer’s Disease and TRD. XPro for AD has completed Phase I trials and a Phase II trial has completed enrollment of patients at clinical sites in the United Kingdom, EU, Australia and Canada. Patients are currently being treated with XPro for Early AD as part of that clinical trial. TRD is being prepared for Phase II trials.
Added
We intend to file a Marketing Authorization Application (“MAA”) in the United Kingdom and the European Union, followed by a Biologics License Application (“BLA”) with the U.S. Food and Drug Administration (“FDA”) targeted for 2026.
Removed
We expect to start a pivotal global registration trial in patients with AD after the results of the Phase II trial have been analyzed. The INKmune program is in an open label Phase II trial in metastatic castrate resistant prostate cancer (mCRPC). CORDStrom for the treatment of children with RDEB has completed a pivotal blinded randomized cross-over trial.
Added
Neuroinflammation and Oncology Pipelines In addition to our lead rare disease program, the Company is advancing two other clinical-stage platf orms: ● XPro1595 (XPro): A next-generation protein therapeutic that targets neuroinflammation by selectively neutralizing soluble TNF.
Removed
The data will be submitted for a marketing authorization by filing a Biologics License Application (BLA) with the FDA in the US which is anticipated in late 2025 or early 2026.
Added
XPro has completed Phase I and Phase II clinical trials for the treatment of Alzheimer’s Disease (“AD”), with enrollment spanning clinical sites in the United Kingdom, the European Union, Australia, and Canada. ● INKmune™: A novel natural killer (NK) cell-priming platform designed to harness the patient’s own innate immune system to eliminate cancer cells.
Removed
Afterwards, the company intends to file a Marketing Authorization Application (MAA) in the United Kingdom and EU. 55 CORDStrom, developed by INmune Bio circa 2020, represents a breakthrough in mesenchymal stem cell technology.
Added
The INKmune program is currently nearing the completion of an open-label Phase II trial for the treatment of metastatic castrate-resistant prostate cancer (“mCRPC”). By targeting the innate immune system across these distinct therapeutic areas, INmune Bio aims to deliver disease-modifying treatments for patients with high unmet medical needs.
Removed
The CORDStrom platform leverages, among other things, proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled human umbilical cord -derived mesenchymal stromal cells (HucMSCs) as medicines to treat complex inflammatory diseases.
Added
We reported a net loss of $45.9 million and $42.1 million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025 and 2024, we had cash and cash equivalents of $24.8 million and $20.9 million, respectively.
Removed
CORDStrom products are designed to provide high-quality, off-the-shelf, batch-to-batch consistent, scalable, cGMP manufactured, potent cellular medicines that can be produced at low cost and with repeatable specification independent of donor characteristics.
Added
The Australian research and development tax incentive is recognized when there is reasonable assurance that the incentive will be received, the relevant expenditure has been incurred and the amount of the consideration can be reliably measured.
Removed
Initially developed at the INKmune manufacturing facilities utilizing United Kingdom academic grant funding, CORDStrom is a product platform that shows promise as a therapy for RDEB and many other debilitating conditions.
Added
There can be no assurance that any such applications will be submitted on our anticipated timeline, accepted for review, approved within any particular timeframe, or approved at all. 60 The regulatory review process in each jurisdiction is lengthy, complex, and inherently unpredictable. Regulatory authorities may require additional information, analyses, or clinical data, which could result in delays or prevent approval.
Removed
While the first generation CORDStrom product is agnostic to indication, the platform enables creation of indication-specific products, which can be tuned for optimization of anti-inflammatory, immunomodulatory, wound healing, and other characteristics.
Added
Even if approval is obtained in one or more jurisdictions, we may experience delays in commercial launch, pricing and reimbursement approvals, manufacturing scale-up, distribution, or market acceptance. Accordingly, we may not generate any product revenue for the foreseeable future, if ever.
Removed
The CORDStrom product platform shares many similarities, including starting materials, equipment, and procedures, with the Company’s INKmune oncology product, enabling the Company to leverage economies of scale, experienced staff, and other resources to strategically manufacture both products in a rotational campaign with resource and environmental efficiencies.
Added
We expect to continue to incur significant operating expenses and substantial losses as we pursue regulatory approvals, prepare for potential commercialization, and continue development of our product candidates.
Removed
Children with Recessive Dystrophic Epidermolysis Bullosa (RDEB) have skin that is damaged by even the smallest amount of friction which causes severe blistering, deep wounds, and scars. It is caused by a fault in a gene that makes collagen, a protein that holds the skin layers together.
Added
Our operating results are likely to fluctuate significantly from quarter to quarter and year to year due to the timing and outcome of regulatory submissions, regulatory review processes in multiple jurisdictions, potential approval decisions, and commercial preparation activities.
Removed
There are limited options available for treatment, none that adequately meet the needs of patients, and the condition gets worse over time with most children reliant on a wheelchair as they move into their teenage years.
Added
CORDStrom Clinical Data License Agreement On February 6, 2025, the Company and Great Ormond Street Hospital for Children NHS Foundation Trust (“GOSH”) entered into a license agreement for the exclusive commercial use to clinical trial data associated with a GOSH study investigating the potential of CORDStrom to treat RDEB in pediatric patients (the “MissionEB study”).
Removed
Many of those with an RDEB diagnosis will also go on to develop aggressive life-threatening skin cancer in adulthood caused by the accumulated damage to their skin. The Company estimates roughly 2,000 people suffer from RDEB in the US, United Kingdom and EU representing a large unmet opportunity to potentially provide routine clinical care to these children.
Added
The Company owns the intellectual property covering CORDStrom, the investigational medicinal product used in the Mission EB study. In addition, the Company owns intellectual property and maintains trade secret protections covering the manufacturing of CORDStrom.
Removed
Since 2020, the Company has supplied CORDStrom HucMSCs as an investigational medical product to the Great Ormond Street Hospital (GOSH), London, in connection with the MissionEB study, which was primarily funded by a grant from the National Institute for Health and Care Research (NIHR) in the United Kingdom.
Added
With this license to the clinical trial data, the Company intends to prepare applications seeking marketing authorization of CORDStrom for treatment of pediatric RDEB in each of the FDA, EMA, and MHRA. Xencor In October 2017, we licensed INB03 (also known as XPro) from Xencor.
Removed
INmune Bio was compensated for CORDStrom used in the trial and was not a sponsor of the Mission EB study.
Added
The increase in general and administrative expenses is mainly due to higher stock-based compensation ($1.3 million higher), partially offset by lower investor relations expense ($0.2 million lower) and lower payroll expense ($0.2 million lower) compared to the prior year.
Removed
Investigators recently concluded a double blinded, placebo-controlled arm of the study, which evaluated the safety and efficacy of CORDStrom in 30 pediatric patients (less than 16 years old) in the United Kingdom with intermediate and severe RDEB using a novel cross-over clinical trial design.
Added
Impairment of acquired in-process research and development intangible assets During the year ended December 31, 2025, the Company released the Phase 2 clinical trial results for our Alzheimer’s drug candidate, XPro, which failed to meet the primary endpoint, though a subgroup showed potential benefits.
Removed
Patients were randomized to CORDStrom or placebo arms and received 2, intravenous infusions two weeks apart and then followed for 9 months. Each child then crossed over to the other arm and received two doses of placebo or CORDStrom two weeks apart with a further 9-month follow-up.
Added
Due to insufficient resources to fund further trials, the Company has halted immediate plans to develop XPro for Alzheimer’s or other indications and are instead seeking a partner to continue these studies. As part of preparing its consolidated financial statements, the Company determined that the intangible asset’s fair value was likely below its carrying value.
Removed
All patients were treated as day-cases and no CORDStrom related serious adverse events were reported through the study. Top-line results showed the treatment was easily administered, well tolerated and there were beneficial effects across all types of patients receiving CORDStrom with respect to Itch Man Scale, iscorEB clinician score and iscorEB skin involvement.
Added
Following a quantitative impairment assessment, the Company estimated the asset’s fair value at $0, resulting in a recorded impairment of $16.5 million during the second quarter of 2025. Other Income, net During 2025, the Company recognized $0.6 million of gain on the forgiveness of payables compared to $0 in 2024.
Removed
Most notably, CORDStrom significantly reduced itch scores as measured by the Itch Man Scale. In patients with the most severe disease activity, CORDStrom reduced itch at 3 months and led to a sustained reduction of over 27% at 6 months. These results demonstrate a clinically meaningful reduction in itch severity sustained over time.
Added
Also, in 2025 the Company recognized $0.9 million of interest income compared to $1.3 million in 2024.
Removed
Intermediate group patients showed a broader range of improvements, including reduced skin involvement and less pain as well as large reduction in itch. The younger patients (less than 10 years old) showed improvements in skin score, indicating better skin integrity and reduced disease activity.
Added
As of December 31, 2025, we had cash and cash equivalents of $24,751,000. We anticipate that we will continue to incur net losses for the foreseeable future as we continue the research and development of our product candidates, expand our clinical activities, hire additional personnel, and incur expenses associated with operating as a public company.
Removed
Interviews with patients and caregivers on completing follow up strongly support the clinical benefits of the therapy; both caregivers and patients were able to correctly identify which treatment had been CORDStrom and which had been placebo.
Added
We expect to incur significant expenses and operating losses as we advance our clinical development programs, pursue regulatory submissions, and, if approved, prepare for the potential commercialization of CORDStrom.
Removed
Those who completed the study are asking to continue on therapy, which the Company intends to pursue as an open-label study. 56 The Mission EB data form the basis of a license that was entered into between INmune Bio and GOSH, whereby the Company gains exclusive access to the clinical study data for commercial uses in exchange for payment of an initiation milestone of £250,000 (approximately $0.3 million at February 6, 2025) and a single development milestone of approximately £6 million (approximately $7.5 million at February 6, 2025) due on receipt of first marketing authorization from the FDA, EMA, or MHRA, and an ongoing commitment to supply CORDStrom to patients enrolled in an open label arm of the Mission EB trial, subject to certain limitations.
Added
As a result, we expect that we will require additional capital to fund our operations, which we may seek to obtain through equity or debt financings, collaborations, licensing arrangements, or other strategic transactions. There can be no assurance that such financing will be available on acceptable terms, or at all.
Removed
After reviewing results of the Mission EB study, the Company initiated a Type C meeting with the FDA to obtain CMC and regulatory feedback and submitted information, data and requests for Rare Pediatric Disease and Orphan Drug Designations (RPDD/ODD).

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Other INMB 10-K year-over-year comparisons