Inmune Bio, Inc. 10-Q

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations Forward-Looking Statements This Form 10-Q contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained in this Form 10-Q that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “estimate” or “continue” or comparable terminology are intended to identify forward-looking statements. These statements by their nature involve substantial risks and uncertainties, and actual results may differ materially depending on a variety of factors, many of which are not within our control. These factors include but are not limited to economic conditions generally and in the industries in which we may participate; competition within our chosen industry, including competition from much larger competitors; technological advances and failure to successfully develop business relationships. Description of Business 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. 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. 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. 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. 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. Neuroinflammation and Oncology Pipelines In addition to our lead rare disease program, the Company has two other clinical-stage platforms: ● XPro1595 (XPro) : A next-generation protein therapeutic that targets neuroinflammation by selectively neutralizing soluble TNF. XPro has completed Phase I and Phase II clinical trials for the treatment of Alzheimer’s Disease (“AD”). The Company intends to pursue strategic partnership opportunities to support the further development of XPro in neurodegenerative and/or other indications. The Company does not currently plan to independently advance XPro into later-stage development. ● INKmune™: A novel natural killer (NK) cell-priming platform designed to harness the patient’s own innate immune system to eliminate cancer cells. 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”). 12 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. 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. We reported a net loss of $5.4 million for the three months ended March 31, 2026. As of March 31, 2026 and December 31, 2025, we had cash and cash equivalents of $21.4 million and $24.8 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. 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. Our recurring net 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 unaudited condensed consolidated financial statements for the three months ended March 31, 2026. Until we can generate sufficient revenue from the commercialization of our product candidates, we expect to finance our operations through the public or private sale of equity, debt financings or other capital sources, such as government funding, collaborations, strategic alliances, divestment of non-core assets, or licensing arrangements with third parties. To date, the Company has relied on equity and debt financing to fund its operations. Amendment to Anthony Nolan License Agreement On April 29, 2026, the Company entered into an amended and restated material transfer and license agreement with Anthony Nolan, a UK-based organization, which amends and restates a prior agreement originally entered into in 2017 by the Company’s wholly owned subsidiary. In connection with the amended agreement, the Company became a direct party and agreed to be jointly and severally liable for certain payment obligations thereunder. The amended agreement expands the Company’s collaboration with Anthony Nolan and is intended to secure a long-term supply of umbilical cord tissue to support the development of CORDStrom, which the Company expects will be the initial application of such materials, with potential use in additional product candidates in the future. Under the amended agreement, the Company has obtained exclusive rights, with the ability to sublicense, to use specified donor materials for research, development and commercialization purposes. The Company is obligated to pay per-sample processing fees and, upon commercialization, royalties on net sales, each subject to certain adjustments and caps, and such fees may be subject to periodic increases tied to inflation indices. The agreement continues until terminated in accordance with its terms or for a period extending beyond the first commercial sale of applicable products. The Company does not expect the amended agreement to have a material impact on its near-term results of operations or liquidity; however, it may result in future payment obligations and become material in the event of successful development and commercialization of product candidates utilizing such materials. The Company believes this agreement is consistent with its strategy to advance its product candidates through collaborations, strategic relationships and licensing arrangements. Research and Development Research and development expense consists of expenses incurred while performing research and development activities to discover and develop our product candidates. This includes conducting preclinical studies and clinical trials, manufacturing development efforts and activities related to regulatory filings for product candidates. We recognize research and development expenses as they are incurred. 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): Three Months Ended March 31, 2026 2025 External Costs DN-TNF - Alzheimer’s disease $ 315 $ 4,852 INKmune and CORDStrom 2,223 1,273 Preclinical and other programs 3 - Accrued research and development rebate (7 ) (93 ) Total external costs 2,534 6,032 Internal costs 1,107 1,607 Total $ 3,641 $ 7,639 We typically use our employee resources across our development programs. 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. 13 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. 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. 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. 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 our research and development expenses to date have been incurred in connection with our current and future product candidates. We expect our research and development expenses to increase significantly for the foreseeable future as we advance an increased number of our product candidates through clinical development, including the conduct of our planned clinical trials and manufacturing drug to be used in those clinical trials. The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. The successful development of product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing or costs required to complete the remaining development of any product candidates. This is due to the numerous risks and uncertainties associated with the development of product candidates. 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, labelling and storage drug used in the clinical trial. 14 We do not expect any of our product candidates to be commercially available for at least the next several years, if ever. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future, which may fluctuate significantly from quarter-to-quarter and year-to-year. 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 candidates 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. Results of Operations Comparison of the Three Months Ended March 31, 2026 and 2025 The following table summarizes our results of operations for the periods indicated: Three Months Ended March 31, (in thousands) 2026 2025 Change Revenues $ - $ 50 $ (50 ) Operating expenses: Research and development 3,641 7,639 (3,998 ) General and administrative 2,171 2,316 (145 ) Total operating expenses 5,812 9,955 (4,143 ) Loss from operations (5,812 ) (9,905 ) (4,093 ) Other expense, net 405 166 239 Net loss $ (5,407 ) $ (9,739 ) $ (4,332 ) Revenues During the three months ended March 31, 2025 the Company recognized $50,000 of revenues from a license agreement. Research and Development Research and development expenses were approximately $3.6 million during the three months ended March 31, 2026, compared to approximately $7.6 million during the three months ended March 31, 2025. The decrease in research and development expenses during the three months ending March 31, 2026 compared to the three months ending March 31, 2025 is largely due to the Company incurring $4.5 million less expenses related to our Alzheimer’s clinical program due to the Company completing its Phase 2 trial during 2025 and $0.5 million lower expenses due to the Company incurring lower compensation expense, partially offset by the Company incurring $1.0 million of higher CORDStrom/INKmune costs related to preparations to submit CORDStrom for marketing authorization in the United Kingdom, Europe and the United States. General and Administrative General and administrative expenses were approximately $2.2 million and $2.3 million during the three months ended March 31, 2026 and 2025, respectively. This decrease is due to the Company incurring lower stock-based compensation expense. 15 Other Expense, net During the three months ended March 31, 2026 and March 31, 2025, the Company recorded $0.4 million and $0.2 million of other income, respectively. The increase in other income is mainly due to a gain on the settlement of a vendor payable during March 2026. 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 $5.4 million and $9.7 million for the three months ended March 31, 2026 and 2025, respectively. Net cash used in operating activities was $3.4 million and $6.8 million for the three months ended March 31, 2026 and 2025, respectively. Since inception, we have funded our operations primarily with proceeds from the sales of our common stock. As of March 31, 2026, we had cash and cash equivalents of $21.4 million. We anticipate that operating losses and net cash used in operating activities will increase over the next few years as we advance our products under development. Our primary uses of capital are, and we expect will continue to be, third-party clinical and preclinical research and development services, costs incurred to manufacture our drugs under development, compensation and related expenses, legal, patent and other regulatory expenses and general overhead costs. We believe our use of CROs provides us with flexibility in managing our spending. The Company incurs significant research and development expenses in Australia and the United Kingdom. Fluctuations in the rate of exchange between the United States dollar and the pound sterling as well as the Australian dollar could adversely affect our financial results, including our expenses as well as assets and liabilities. We currently do not hedge foreign currencies but will continue to assess whether that strategy is appropriate. As of March 31, 2026, the cash balance held by our foreign subsidiaries with currencies other than the United States dollar was approximately $0.4 million. 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 unaudited condensed consolidated financial statements for the year ended March 31, 2026. Until we can generate sufficient revenue from the commercialization of our product candidates, we expect to finance our operations through the public or private sale of equity, debt financing or other capital sources, such as government funding, collaborations, strategic alliances, divestment of non-core assets, or licensing arrangements with third parties. Our cash and cash equivalents were $21.4 million and total current assets were $22.8 million at March 31, 2026, 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. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development of one or more of our product candidates or cease operations. If we raise additional funds through the issuance of additional debt or equity securities it could result in dilution to our existing stockholders, increased fixed payment obligations and these securities may have rights senior to those of our common stock and could contain covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license our intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Any of these events could significantly harm our business, financial condition and prospects. 16 Financing strategies we may pursue include, but are not limited to, the public or private sale of equity, debt financing or funds from other capital sources, such as government or grant funding, collaborations, strategic alliances, divestment of non-core assets, or licensing arrangements with third parties. There can be no assurances additional capital will be available to secure additional financing, or if available, that it will be sufficient to meet our needs on favorable terms. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development of one or more of our product candidates. If we raise additional funds through the public or private sale of equity or debt financings, it could result in dilution to our existing stockholders or increased fixed payment obligations and these securities may have rights senior to those of our common stock and could contain covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license our intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Any of these events could significantly harm our business, financial condition and prospects. Cash Flows The following table summarizes our cash flows for the periods indicated: Three Months Ended March 31, (in thousands) 2026 2025 Net cash and cash equivalents (used in) provided by: Operating activities $ (3,403 ) $ (6,824 ) Financing activities - 5,274 Change in cash and cash equivalents (3,403 ) (1,550 ) Impact on cash from foreign currency translation 10 (35 ) Cash and cash equivalents, beginning of period 24,751 20,922 Cash and cash equivalents, end of period $ 21,358 $ 19,337 Operating Activities Operating activities used approximately $3.4 million of cash during the three months ended March 31, 2026, and was primarily due to our net loss of $5.4 million, partially offset by non-cash stock-based compensation of $1.5 million and changes in our net operating assets and liabilities of $0.5 million which is primarily due to an decrease in research and development tax credit receivable of $3.8 million partially offset by a decrease in accounts payable and accrued liabilities of $3.0 million. Operating activities used approximately $6.8 million of cash during the three months ended March 31, 2025, and was primarily due to our loss of $9.7 million, partially offset by non-cash stock-based compensation of $2.1 million and changes in our net operating assets and liabilities of $0.8 million which is mainly due to an increase in accounts payable and accrued liabilities of $0.7 million. Financing Activities During the three months ended March 31, 2025, the Company sold 649,860 shares of common stock in exchange for net proceeds of $5.3 million. Critical Accounting Policies and Estimates Our discussion and analysis of our financial condition and results of operations is based upon our unaudited condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses. Actual results may differ from these estimates. Our critical accounting policies and estimates are discussed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and there have been no material changes during the three months ended March 31, 2026. 17 Item 3. Quantitative and Qualitative Disclosures About Market Risk Pursuant to Item 305(e) of Regulation S-K (§ 229.305(e)), the Company is not required to provide the information required by this Item as it is a “smaller reporting company,” as defined by Rule 229.10(f)(1).