Inmune Bio, Inc.
For the period ended Sep 30, 2026. Filed Nov 5, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 5, 2026
INMB$1.13-3.8%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001213900-26-086135
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-05.
0001213900-26-116359
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 73 previous paragraphs and 78 current paragraphs.
44 unchanged; 22 reworded; 12 added; 6 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 24 previous and 24 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (12)
Current report
During the three months ended September 30, 2026, the Company’s other income consisted of interest income.
Current report
During the three months ended September 30, 2025, the Company recorded $1.0 million of other income, of which approximately $0.6 million was gain on forgiveness of payables from two vendors and approximately $0.4 million was due to interest income.
Current report
Comparison of the Nine Months Ended September 30, 2026 and 2025
Current report
Other Income, net
Current report
During the nine months ended September 30, 2026 and 2025, the Company earned $0.9 million and $1.2 million of other income.
Current report
During the nine months ended September 30, 2026, the Company’s other income mainly consisted of $0.6 million of interest income and $0.1 million of gain on foreign exchange and $0.1 million of gain on settlement of accounts payable.
Current report
During the nine months ended September 30, 2025, the Company recorded $1.2 million of other income, of which $0.6 million was due to the Company earning interest income on its cash investments and $0.6 million was gain on forgiveness of payables.
Current report
Based on our current research and development plans, we do not anticipate receiving material additional research and development tax rebates from Australia in the near term. Accordingly, the Australian rebate receipts during the nine months ended September 30, 2026 are not indicative of expected future receipts.
Current report
Common stock and warrant financing
Current report
On October 29, 2026, the Company received approximately $4.0 million in net proceeds from the sale of common stock, in a registered direct offering, and from the issuance in a concurrent private placement of warrants to purchase common stock. These proceeds provided additional liquidity to fund the Company’s ongoing operations.
Current report
Operating activities used approximately $19.6 million of cash during the nine months ended September 30, 2025, primarily reflecting our net loss of $40.7 million, net cash used from changes in operating assets and liabilities of $1.5 million, and an adjustment to remove a non-cash gain on forgiveness of accounts payable of $0.6 million, partially offset by non-cash impairment expense of $16.5 million and stock-based compensation expense of $6.6 million. The net cash used from changes in operating assets and liabilities primarily reflected increases in other assets of $0.7 million, research and development tax credit receivable of $0.5 million and other tax receivable of $0.5 million, together with a decrease in deferred liabilities of $0.5 million, partially offset by an increase in accounts payable and accrued liabilities of $1.0 million.
Current report
During the nine months ended September 30, 2026, option holders exercised 57,292 options in exchange for $0.1 million of cash.
Removed paragraphs (6)
Previous report
Other Expense, net
Previous report
During the three months ended June 30, 2026 and June 30, 2025, the Company recorded $0.2 million and $0.1 million of other income, respectively, mainly from interest income on investments. The increase in other income is mainly due to higher interest income as a result of higher amounts invested.
Previous report
Comparison of the Six Months Ended June 30, 2026 and 2025
Previous report
During the six months ended June 30, 2026 and 2025, the Company recorded $0.6 million and $0.3 million, respectively, of other income primarily from earning interest income on its cash investments. The increase in other income in 2026 was due to higher interest income from cash on its investments and also due to a foreign exchange gain on the settlement of a payable.
Previous report
Subsequent to the quarter ending June 30, 2026, the Company sold 100,000 shares of common stock at an average price of $2.09 per share for aggregate net proceeds of approximately $0.2 million.
Previous report
Operating activities used approximately $14.2 million of cash during the six months ended June 30, 2025, resulting mainly from our loss of $34.2 million, partially offset by an intangibles impairment expense of $16.5 million and non-cash stock-based compensation of $3.6 million.
Reworded paragraphs (22)
Previous wording
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 by the end of Q3 or early Q4 of 2026 and the European Union in early 2027, followed by a Biologics License Application (“BLA”) with the U.S. Food and Drug Administration (“FDA”).
Current wording
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 during February 2027, followed by a Biologics License Application (“BLA”) with the U.S. Food and Drug Administration (“FDA”) planned for mid-2027 and then the European Union application.
Previous wording
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 $6.7 million for the six months ended June 30, 2026. As of June 30, 2026 and December 31, 2025, we had cash and cash equivalents of $18.4 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.
Current wording
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 $11.4 million for the nine months ended September 30, 2026. As of September 30, 2026 and December 31, 2025, we had cash and cash equivalents of $16.3 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.
Previous wording
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 six months ended June 30, 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.
Current wording
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 nine months ended September 30, 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.
Previous wording
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.
Current wording
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 personnel costs including salaries and stock-based compensation to specific product candidates or development programs.
Previous wording
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:
Current wording
We are targeting regulatory approval for CORDStrom in the United Kingdom in 2027, although the timing and outcome of the regulatory review remain uncertain. If approval is obtained, we intend to commence commercialization following completion of the necessary commercial preparations. We expect to continue to incur significant expenses and operating losses for the foreseeable future, including as we prepare for potential commercialization, and these amounts may fluctuate significantly from quarter to quarter and year to year. We anticipate that our expenses will increase substantially as we:
Previous wording
Research and development benefit was approximately $0.8 million during the three months ended June 30, 2026, compared to research and development expense of approximately $5.8 million during the three months ended June 30, 2025. The Company recorded $4.2 million of additional R&D rebate during the three months ended June 30, 2026 primarily as a result of the completion of the Australian government's review of the Company’s 2025 R&D claim. In addition, the Company incurred $3.3 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 internal costs, partially offset by the Company incurring $1.4 million of higher CORDStrom/INKmune costs related to preparations to submit CORDStrom for marketing authorization in the United Kingdom, Europe and the United States.
Current wording
Research and development expense was approximately $3.2 million and $4.9 million during the three months ended September 30, 2026 and 2025, respectively. The Company recorded $0.7 million of additional R&D rebate during the three months ended September 30, 2026 as a result of the Company recording additional amounts which it estimates are recoverable pursuant to the UK R&D rebate program. In addition, the Company incurred $1.1 million less expenses related to our Alzheimer’s clinical program due to the Company completing its Phase 2 trial during 2025, and $1.3 million lower expenses due to the Company incurring lower internal costs, partially offset by the Company incurring $1.3 million of higher CORDStrom/INKmune costs related to preparations to submit CORDStrom for marketing authorization in the United Kingdom, Europe and the United States.
Previous wording
General and administrative expenses were approximately $2.3 million during the three months ended June 30, 2026 and 2025.
Current wording
General and administrative expenses were $1.8 million and $2.5 million during the three months ended September 30, 2026 and 2025, respectively. The decrease in costs in 2026 is mainly due to the Company incurring $0.8 million lower stock-based compensation in 2026.
Previous wording
During the six months ended June 30, 2025, the Company recognized revenue from a license agreement that was terminated during 2025.
Current wording
During the nine months ended September 30, 2025, the Company recognized revenue from a license agreement that was terminated during 2025.
Previous wording
Research and development expenses were approximately $2.8 million and $13.4 million during the six months ended June 30, 2026 and 2025, respectively. The change in research and development expenses during the six months ending June 30, 2026 compared to the six months ending June 30, 2025 is mainly due to the Company incurring $7.8 million less Alzheimer’s clinical program expenses due to the trial being completed in 2025, $4.1 million higher rebate mainly due to additional amounts recorded in connection with the completion of a review of the 2025 rebate claim in Australia and $1.0 million lower internal costs, partially offset by the Company recording $2.3 million higher expenses for CORDStrom/INKmune related to preparations to submit CORDStrom for marketing authorization in the United Kingdom, Europe and the United States.
Current wording
Research and development expenses were approximately $6.0 million and $18.3 million during the nine months ended September 30, 2026 and 2025, respectively. The change in research and development expenses during the nine months ending September 30, 2026 compared to the nine months ending September 30, 2025 is mainly due to the Company incurring $8.9 million less Alzheimer’s clinical program expenses due to the trial being completed in 2025, $4.8 million higher rebate mainly due to additional amounts recorded in connection with the receipt of the 2025 rebate claim by the Australia subsidiary as well as recording additional amounts for the UK subsidiary as a result of additional R&D activity in the UK and $2.3 million lower internal costs, partially offset by the Company recording $3.6 million higher expenses for CORDStrom/INKmune related to preparations to submit CORDStrom for marketing authorization in the United Kingdom, Europe and the United States.
Previous wording
General and administrative expenses were approximately $4.5 million and $4.6 million during the six months ended June 30, 2026 and 2025, respectively. The decrease in general and administrative expenses was mainly due to incurring lower professional fees in 2026.
Current wording
General and administrative expenses were approximately $6.3 million and $7.1 million during the nine months ended September 30, 2026 and 2025, respectively. The decrease in general and administrative expenses was mainly due to incurring $0.8 million lower stock-based compensation expense in 2026.
Previous wording
During the six months ended June 30, 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. Due to insufficient resources to fund further trials, the Company has halted immediate plans to develop XPro for Alzheimer’s or other indications and is instead seeking a partner to continue these studies. As part of preparing its interim unaudited condensed consolidated financial statements, the Company determined that the intangible asset’s fair value was likely below its carrying value. Following a quantitative impairment assessment, the Company estimated the asset’s fair value at $0 as of June 30, 2025, resulting in a recorded impairment of $16.5 million.
Current wording
During the nine months ended September 30, 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. Due to insufficient resources to fund further trials, the Company has halted immediate plans to develop XPro for Alzheimer’s or other indications and is instead seeking a partner to continue these studies. As part of preparing its interim unaudited condensed consolidated financial statements, the Company determined that the intangible asset’s fair value was likely below its carrying value. 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.
Previous wording
We incurred a net loss of $6.7 million and $34.2 million for the six months ended June 30, 2026 and 2025, respectively. Net cash used in operating activities was $6.6 million and $14.2 million for the six months ended June 30, 2026 and 2025, respectively. Since inception, we have funded our operations primarily with proceeds from the sales of our common stock. As of June 30, 2026, we had cash and cash equivalents of $18.4 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.
Current wording
We incurred a net loss of $11.4 million and $40.7 million for the nine months ended September 30, 2026 and 2025, respectively. Net cash used in operating activities was $10.0 million and $19.6 million for the nine months ended September 30, 2026 and 2025, respectively. Since inception, we have funded our operations primarily with proceeds from the sales of our common stock. As of September 30, 2026, we had cash and cash equivalents of $16.3 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.
Previous wording
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 as of and for the six months ended June 30, 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 $18.4 million and total current assets were $23.8 million at June 30, 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.
Current wording
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 as of and for the nine months ended September 30, 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 $16.3 million and total current assets were $18.7 million at September 30, 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.
Previous wording
On December 19, 2025, the Company entered into a sales agreement with A.G.P./Alliance Global Partners (“AGP”), as sales agent, pursuant to which the Company may offer and sell, from time to time, up to $65,000,000 of shares of its common stock through AGP in exchange for a 3% commission on gross proceeds. During the six months ended June 30, 2026, the Company sold 370,417 shares of common stock at an average price of $1.63 per share under the ATM program. The aggregate net proceeds were approximately $0.6 million after expenses.
Current wording
On December 19, 2025, the Company entered into a sales agreement with A.G.P./Alliance Global Partners (“AGP”), as sales agent, pursuant to which the Company may offer and sell, from time to time, up to $65,000,000 of shares of its common stock through AGP in exchange for a 3% commission on gross proceeds. During the nine months ended September 30, 2026, the Company sold 598,947 shares of common stock at an average price of $1.80 per share under the ATM program. The aggregate net proceeds were approximately $1.0 million after expenses.
Previous wording
On June 30, 2026, the Company entered into a warrant inducement agreement with certain holders of its April 2024 common stock purchase warrants. Under the agreements, the holders exercised an aggregate of 674,155 warrants, representing 50% of their holdings, at a reduced exercise price of $1.40 per share (original exercise price of $1.95), resulting in gross proceeds to the Company of approximately $0.9 million, of which approximately $0.1 million was received on June 30, 2026 and $0.8 million was received on July 1, 2026.
Current wording
On June 30, 2026, the Company entered into a warrant inducement agreement with certain holders of its April 2024 common stock purchase warrants. Under the agreements, the holders exercised an aggregate of 674,155 warrants, representing 50% of their holdings, at a reduced exercise price of $1.40 per share (original exercise price of $1.95), resulting in gross proceeds to the Company of approximately $0.9 million.
Previous wording
During the six months ended June 30, 2026, the Company received approximately $4.4 million of cash rebates under these programs, consisting of approximately $3.6 million from Australia and approximately $0.8 million from the United Kingdom. In addition, the Company received a further approximately $4.2 million research and development rebate from Australia on July 30, 2026. These cash receipts have strengthened the Company's liquidity and supported the funding of its ongoing operations.
Current wording
During the nine months ended September 30, 2026, the Company received approximately $8.6 million of cash rebates under these programs, consisting of approximately $7.8 million from Australia and approximately $0.8 million from the United Kingdom. These cash receipts have strengthened the Company’s liquidity and supported the funding of its ongoing operations.
Previous wording
Operating activities used approximately $6.6 million of cash during the six months ended June 30, 2026, primarily reflecting our net loss of $6.7 million and approximately $2.8 million of cash used from changes in operating assets and liabilities, principally a $2.6 million decrease in accounts payable and accrued liabilities. These uses were partially offset by approximately $2.9 million of non-cash stock-based compensation expense.
Current wording
Operating activities used approximately $10.0 million of cash during the nine months ended September 30, 2026, primarily reflecting our net loss of $11.4 million and approximately $2.6 million of cash used from changes in operating assets and liabilities, principally a $5.5 million decrease in accounts payable and accrued liabilities and a $0.3 million increase in other taxes receivable. These uses were partially offset by approximately $4.0 million of non-cash stock-based compensation expense.
Previous wording
During the six months ended June 30, 2026 and 2025, the Company acquired $0.4 million and $0.7 million, respectively, of equipment to be used in its CORDStrom clinical program.
Current wording
During the nine months ended September 30, 2026 and 2025, the Company acquired $0.4 million and $0.9 million, respectively, of equipment to be used in its CORDStrom clinical program.
Previous wording
During the six months ended June 30, 2026, the Company sold 370,417 shares of common stock under its ATM program for net proceeds of $0.6 million.
Current wording
During the nine months ended September 30, 2026, the Company sold 598,947 shares of common stock under its ATM program for net proceeds of $1.0 million.
Previous wording
During June 2026, holders exercised 674,155 warrants for aggregate gross proceeds of approximately $0.9 million. The Company received approximately $0.1 million by June 30, 2026, and recorded the remaining $0.8 million as a subscription receivable, which was collected on July 1, 2026.
Current wording
During June 2026, holders exercised 674,155 warrants for aggregate gross proceeds of approximately $0.9 million.
Previous wording
During the six months ended June 30, 2025, the Company sold 1,304,707 shares of common stock under its ATM program for net proceeds of $10.1 million.
Current wording
During the nine months ended September 30, 2025, the Company sold 1,304,707 shares of common stock under its ATM program for net proceeds of $10.1 million.
Previous wording
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 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 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 six months ended June 30, 2026.
Current wording
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 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 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 nine months ended September 30, 2026.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
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.