IN8BIO, INC.
For the period ended Mar 31, 2026. Filed May 7, 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.
Mar 31, 2026 · Filed May 7, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-06.
0001193125-25-269447
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-07.
0001193125-26-212135
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 121 previous paragraphs and 115 current paragraphs.
73 unchanged; 22 reworded; 17 added; 24 removed; 2 previous and 3 current paragraphs rearranged.
Tables are not compared: 5 previous and 3 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 (17)
Current report
Most recently we introduced INB-600, our proprietary, internally developed TCE platform. We have demonstrated that INB-619, a CD19 targeted gamma-delta TCE can efficiently and completely eliminate targeted B cells in a dose-dependent manner. Data presented at The American College of Rheumatology Convergence 2025 meeting ("ACR Convergence 2025") highlighted the potential of INB-619 in B cell-driven autoimmune diseases such as systemic lupus erythematosus ("SLE") and demonstrated deep B cell depletion through selective activation and expansion of gamma-delta T cells.
Current report
At the 2025 Annual Meeting of the Society of Neuro-Oncology ("SNO"), we presented consolidated data from the INB-200 (Phase 1) and INB-400 (Phase 2) trials in both poster and oral presentations.
Current report
This data was updated through December 31, 2025, and patients who received repeated doses of DeltEx DRI gamma-delta T cells reported an mPFS of 13.0 months and an mOS of 17.2+ months, with median overall survival continuing to grow. We continue to believe that our DeltEx DRI approach has the potential to address this significant unmet need and expect to provide further clinical updates, including additional mOS data from the total data set, at medical meetings in mid- and late- 2026.
Current report
We believe our DeltEx DRI gamma-delta T cell therapeutic approach is demonstrating clinical activity and may have the potential applicability across multiple solid tumor types. In April 2023, we received Orphan Drug Designation from the FDA for both the autologous and allogeneic DeltEx DRI INB-400 product candidates, covering a broad range of malignant glioma indications, including relapsed and newly diagnosed GBM. We believe there may be potential regulatory designation pathways available for the autologous DeltEx DRI program in newly diagnosed GBM and intend to seek further guidance from the FDA regarding potential development and regulatory pathways in 2026. Following such regulatory guidance, we expect to evaluate potential funding sources and strategic opportunities to support continued development of this program toward potential commercialization.
Current report
Research and Development Expenses
Current report
General and Administrative Expenses
Current report
Interest Income
Current report
Research and Development Expenses
Current report
Research and development expenses were $2.6 million for the three months ended March 31, 2026, compared to $3.0 million for the prior year period. These amounts include non-cash items such as stock-based compensation ("SBC") and depreciation. The decrease was primarily due to a $0.3 million net decrease in direct costs related to our clinical trials, primarily related to our INB-400 program, and a decrease of $0.3 million in facility related charges, partially offset by increases of $0.1 million in our preclinical TCE program expenses and $0.1 million in personnel-related costs.
Current report
General and Administrative Expenses
Current report
General and administrative expenses were $2.7 million for the three months ended March 31, 2026, compared to $2.7 million for the prior year period. These amounts include non-cash items such as SBC and depreciation.
Current report
Interest Income
Current report
As of the date of this Form 10-Q, our public float was less than $75 million. As a result, we are subject to the limitations of General Instruction I.B.6 to Form S-3 until such time as our public float exceeds $75 million, which means we only have the capacity to sell shares up to one-third of our public float under shelf registration statements in any 12-month period. We will remain constrained by the limitations of General Instruction I.B.6 to Form S-3 until such time as our public float exceeds $75 million, at which time the number of securities we may sell under a Form S-3 registration statement will no longer be limited by limitations of General Instruction I.B.6 to Form S-3.
Current report
An immaterial amount of cash was used in investing activities during the three months ended March 31, 2026 and no cash was used in investing activities during the three months ended March 31, 2025.
Current report
Cash used in financing activities was $(0.2) million during the three months ended March 31, 2026, primarily due to costs associated with the December 2025 private placement transaction.
Current report
During the three months ended March 31, 2026, we did not adopt any new Accounting Standards Updates ("ASUs") issued by the Financial Accounting Standards Board.
Current report
We have evaluated recently issued and unadopted ASUs, and believe the adoption of these standards will not have a material impact on our condensed financial statements.
Removed paragraphs (24)
Previous report
Most recently we introduced INB-600, our proprietary and internally developed T cell engager platform. This platform represents a potentially revolutionary advancement in immunotherapy, harnessing the power of gamma-delta T cells through a distinctive mechanism that optimizes effector function and targeted cytotoxicity. To date, we have observed novel properties of the TCE, which include inducing pan-gamma delta T cell expansion and activation to potentially offer powerful target cell elimination with a sustained and potent anti-tumor or anti-target response. This unique capability may not only enhance the immediate cytotoxic effects but can also build a more durable and long-lasting immune response, essential for combating both solid tumors and resistant leukemias/lymphomas as well as sustained deep target depletion for potential applications in autoimmune diseases. Traditional TCEs often function through CD3-based immune cell activation, which induce cytokine release syndrome ("CRS") and T cell exhaustion by broadly activating all T cells. In contrast, our INB-600 TCE platform selectively activates gamma-delta T cells through targeting of the gamma-delta TCR, which includes both V delta 1+ and V delta 2+ ("Vd1+" and "Vd2+") gamma-delta T cell subsets, leveraging their innate ability to recognize and kill target cells with minimal risk of CRS. The expansion of gamma-delta T cells can drive complete elimination of target cells without CD4 or CD8 expansion, demonstrating the power of this approach. The pan T cell activation and expansion of both the Vd1+ and Vd2+ gamma-delta T cell compartments further enhances our therapeutic potential by combining the rapid antigen presentation, immune activation, and phagocytosis capabilities of Vd2+ cells with the durable, tissue-resident persistence of Vd1+ cells, aimed at driving deeper and more sustained immune responses to eliminate cancers or pathogenic B cells associated with autoimmune disease.
Previous report
In April 2025, at the 2025 American Association for Cancer Research ("AACR") Annual Meeting, we presented in vitro studies that demonstrated INB-619, a CD19 targeting gamma-delta TCE and INB-633, a CD33 targeting gamma-delta TCE induced strong, antigen-specific cytotoxicity against CD19+ acute lymphoblastic leukemia ("ALL") and CD33+ AML cell lines, respectively. Both TCE’s promoted robust gamma-delta T cell expansion, activation and degranulation, with increased expression of IFN-γ, TNF-α, granzyme B, and perforin, indicating a transition to a highly cytotoxic phenotype. Importantly, both engagers exhibited minimal release of inflammatory cytokines which are known to drive CRS and/or tumor promotion, including IL-6, IL-10, and IL-17a.
Previous report
In May 2025, at the 2025 American Society of Gene & Cell Therapy ("ASGCT") Annual Meeting, we presented preclinical data that demonstrated that INB-619 successfully eliminated disease-causing B cells in blood samples from patients with active Systemic Lupus Erythematosus ("SLE" or "Lupus"). INB-619 not only depletes the target CD19+ B cells, but also significantly expands and activates both key types of gamma-delta T cells (Vd1+ and Vd2+), overcoming one of the critical challenges in the clinical use of gamma-delta TCE’s in patients with chronic disease and dysfunctional immune systems, low gamma-delta T cell levels. These findings highlight the potential of INB-619 as a novel treatment option for autoimmune diseases, where harmful B cells secrete antibodies that drive inflammation and tissue damage. Unlike traditional TCEs that target CD3 and can often trigger severe side effects, INB-619 harnesses the unique properties of gamma-delta T cells to selectively eradicate B cells while minimizing inflammatory cytokines such as IL-6. The platform’s ability to effectively deplete B cells suggests potential for therapeutic applications in B cell driven autoimmune diseases.
Previous report
In October 2025, at the 2025 American College of Rheumatology ("ACR") Annual Convergance Meeting, we presented preclinical data demonstrating that INB-619, selectively expanded and activated gamma-delta T cells to drive powerful dose-dependent target elimination. Robust expansion of both Vd1+ and Vd2+ gamma-delta T cells enabled complete B cell depletion from SLE donor PBMCs without CD4 or CD8 expansion, demonstrating precise, targeted activation. INB-619 demonstrated complete B cell depletion comparable to commercially available CD3-based bi-specific TCE's but with a markedly improved cytokine release profile. Importantly, CRS associated cytokines including IL-6, IL-10, IL-4, and TNF-α were minimally released and below the comparators, even at higher nanomolar ("nM") concentrations of INB-619 that are far above the picomolar ("pM") concentrations required for full B cell depletion. These data highlight INB-619's ability to expand gamma-delta T cells and robustly deplete its target with minimal release of CRS associated cytokines. These data highlight INB-619’s ability to expand gamma-delta T cells and robustly eliminate B cells while maintaining a favorable safety profile, supporting a potentially wider therapeutic window that could enable higher dosing and complete immune reset in B cell-mediated autoimmune diseases.
Previous report
We believe the INB-600 platform positions us with promising candidates for a range of potential applications, from solid tumors to autoimmune diseases, with the goal of offering a comprehensive approach to immune system modulation and disease treatment. We expect to present additional preclinical data in the second half of 2025 and in 2026.
Previous report
Research and development expenses were $2.1 million for the three months ended September 30, 2025, compared to $3.3 million for the comparable prior year period. This includes non-cash items such as stock-based compensation ("SBC") and depreciation of $0.5 million for the three months ended September 30, 2025. The decrease of $1.2 million was primarily due to a $1.0 million decrease in direct clinical costs for INB-100, INB-200 and INB-400 and a $0.4 million decrease in personnel-related costs, including salaries and SBC as a result of the decrease in our headcount, partially offset by $0.1 million in increased costs for preclinical and facility related charges.
Previous report
General and administrative expenses were $1.9 million for the three months ended September 30, 2025, compared to $2.7 million for the comparable prior year period. This includes non-cash items such as SBC and depreciation of $0.4 million for the three months ended September 30, 2025. The decrease of $0.8 million was primarily due to a decrease in personnel-related costs, including SBC, cost savings related to directors' and officers' insurance premiums and a reduction in professional services.
Previous report
Comparison of the Nine Months Ended September 30, 2025 and 2024
Previous report
Research and development expenses were $7.6 million for the nine months ended September 30, 2025, compared to $13.4 million for the comparable prior year period. This includes non-cash items such as SBC and depreciation of $1.6 million for the nine months ended September 30, 2025. The decrease of $5.8 million was primarily due to a $2.9 million decrease in personnel-related costs, including salaries and SBC as a result of the decrease in our headcount. Direct clinical costs decreased by $3.1 million due to decreased costs for INB-200 and INB-400.
Previous report
General and administrative expenses were $7.3 million for the nine months ended September 30, 2025, compared to $10.0 million for the comparable prior year period. This includes non-cash items such as SBC and depreciation of $1.7 million for the nine months ended September 30, 2025. The decrease of $2.7 million was primarily due to a decrease in personnel-related costs, including SBC, cost savings related to directors' and officers' insurance premiums and a reduction in professional services.
Previous report
Interest income was $0.3 million and $0.2 million for the nine months ended September 30, 2025 and 2024, respectively.
Previous report
As of September 30, 2025, we had cash of $10.7 million. Our current plan of operation is to execute our business strategy, by advancing clinical development of INB-100, and progressing our other product candidates, including our preclinical pipeline and strengthening our internal research and development capabilities. Additionally, we are actively seeking additional funding and potential collaborative partners for INB-100, INB-400 and our earlier stage assets INB-619 and INB-633. Based on this business strategy, our existing cash as of September 30, 2025 is only expected to fund our projected operating expenses and capital expenditure requirements into June 2026. To continue to fund the operations of the Company beyond this time period, management has developed plans, which primarily consist of the pipeline prioritization announced in September 2024, raising additional capital through some combination of equity and/or debt offerings, including through ATM offerings and private placements of securities, and identifying strategic collaborations, licensing or other arrangements to support development of the Company’s product candidates. If we are unable to raise capital when needed or on acceptable terms, we could be forced to delay, reduce, or explore other strategic options for our research and development programs or other opportunities, or even terminate our operations. If we do not obtain additional financing and are required to terminate our operations, our stockholders will lose all or a part of their investment.
Previous report
Warrant Exercises and Exchanges
Previous report
In April 2025, the Company entered into privately negotiated letter agreements with certain holders of outstanding Series A warrants and Series B warrants (the "Participating Holders") to (i) exercise, for cash, 239,293 Series A warrants and 71,403 Series B warrants for the purchase of an aggregate of 310,696 shares of common stock, in each case at a reduced exercise price of (a) $5.53 per share for Participating Holders who are directors or executive officers of the Company and (b) $5.35 per share for all other Participating Holders (the "Warrant Exercises") and (ii) exchange certain Series A warrants and Series B warrants for 41,014 pre-funded warrants, in each case for a cash payment of (a) $5.53 per warrant share for Participating Holders who are directors or executive officers of the Company and (b) $5.35 per warrant share for all other Participating Holders (the "Warrant Exchanges"), for aggregate net proceeds of $1.9 million. See Note 7, Warrants, in our unaudited condensed financial statements contained elsewhere in this Quarterly Report for additional information.
Previous report
Stock Purchase Agreement Amendment and Series B Warrant Amendment
Previous report
In April 2025, we entered into an Amendment No. 1 to Securities Purchase Agreement (the "SPA Amendment") to amend the restrictions on certain equity sales by us set forth in the Securities Purchase Agreement, dated September 30, 2024, by among us and the investors party thereto. In consideration for the SPA Amendment, we entered into amendments with certain holders of the Series B warrants to reduce the exercise price from $45.00 to $13.50 per share, to the extent such warrants were not exercised pursuant to the Warrant Exercises or exchanged pursuant to the Warrant Exchanges.
Previous report
Outstanding Warrants
Previous report
As of September 30, 2025, we had issued and outstanding 248,382 pre-funded warrants, 129,296 Series A warrants, 303,574 Series B warrants, and 997,638 Series C warrants. The Series A warrants expired on October 4, 2025.
Previous report
Under current SEC regulations, if at any time our public float is less than $75.0 million, and for so long as our public float remains less than $75.0 million, the amount that we can raise through primary public offerings of securities in any 12-month period using shelf registration statements is limited to an aggregate of one-third of our public float, which is referred to as the baby shelf rules. As of September 30, 2025, our public float was less than $75.0 million.
Previous report
Cash used in investing activities was nil during the nine months ended September 30, 2025.
Previous report
Cash used in investing activities was $0.2 million during the nine months ended September 30, 2024, primarily due to purchases of property and equipment and construction in progress activity in relation to capitalized software.
Previous report
Cash provided by financing activities was $3.0 million during the nine months ended September 30, 2024, primarily due to proceeds received from the issuance and sale of common stock pursuant to the ATM program of $3.8 million, partially offset by principal payments of $0.6 million on our leases and $0.2 million of deferred issuance costs.
Previous report
During the nine months ended September 30, 2025, we adopted Accounting Standards Update ("ASU") 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280 on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company adopted ASU 2023-07 effective January 1, 2025. See Note 13, Segments, in the accompanying notes to the condensed financial statements for further detail. Additionally, there is no pending accounting guidance that we expect to have a material impact on the condensed financial statements.
Previous report
In December 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which expands the disclosures required for income taxes. This ASU is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. We are currently evaluating the impact of adopting ASU 2023-09 and we will adopt it for the fiscal year ending December 31, 2025.
Reworded paragraphs (22)
Previous wording
We are a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell product candidates and T cell engagers ("TCEs") for cancer and autoimmune diseases. We are the most clinically advanced gamma-delta T cell-focused company and are utilizing our suite of DeltEx platform technologies as we aspire to eliminate cancer cells to achieve our mission of what we refer to as Cancer Zero TM ─ the safe elimination of all cancer cells in every patient battling the disease. We develop ex vivo expanded and activated gamma-delta T cell candidates and TCEs based upon our deep expertise in gamma-delta T cell biology, proprietary genetic engineering, and cell-type specific manufacturing capabilities, which we refer to collectively as our DeltEx platform. Our platform employs allogeneic, autologous, induced pluripotent stem cell ("iPSC"), genetically modified cell therapy approaches, and TCEs that are designed to effectively identify and eradicate malignant or pathogenic target cells. To date, we have conducted two main investigator-sponsored Phase 1 clinical trials to test our gamma-delta T cell technologies in cancer patients. INB-100 tests our DeltEx Allogeneic ("Allo") gamma-delta T cells in older patients with high-risk leukemias undergoing haploidentical stem cell transplantation ("HSCT") and INB-200 tests our DeltEx Drug Resistant Immunotherapy ("DRI") in newly diagnosed glioblastoma ("GBM") patients. Both trials have demonstrated long-term durable remissions with patients remaining alive and in remission for greater than four years.
Current wording
We are a leading clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell product candidates and T cell engagers ("TCEs") for cancer and autoimmune diseases. We are the most clinically advanced gamma-delta T cell-focused company and are utilizing our suite of DeltEx platform technologies as we aspire to eliminate cancer cells to achieve our mission of what we refer to as Cancer Zero TM — the safe elimination of all cancer and target cells in every patient battling disease. We develop TCEs, along withex vivo expanded and activated gamma-delta T cell candidates based upon our deep expertise in gamma-delta T cell biology, proprietary genetic engineering, and cell-type specific manufacturing capabilities, which we refer to collectively as our DeltEx platform. Our platform employs TCEs, allogeneic, autologous, induced pluripotent stem cell ("iPSC"), and genetically modified cell therapy approaches that are designed to effectively identify and eradicate tumor or target cells. To date, we have conducted two primary investigator-sponsored Phase 1 clinical trials evaluating our gamma-delta T cell technologies in cancer patients, which have both completed primary enrollment. INB-100 is assessing our DeltEx Allogeneic ("Allo") gamma-delta T cell therapy in adult patients with high-risk leukemias undergoing haploidentical stem cell transplantation ("HSCT"). INB-200 evaluated our DeltEx Drug Resistant Immunotherapy ("DRI") in patients with newly diagnosed glioblastoma ("GBM"). Both trials have demonstrated encouraging clinical activity, including long-term durable remissions, with patients remaining alive and in remission or progression-free for more than four years.
Previous wording
INB-100, our first DeltEx allogeneic product candidate, was developed to assess the safety and tolerability of donor-derived manufactured expanded and activated gamma-delta T cells that do not undergo additional genetic modification. The Phase 1 trial of INB-100 has completed primary enrollment and a recommended Phase 2 dose ("RP2D") has been determined. We presented updated data at the 2025 Transplantation & Cellular Therapy ("TCT") Meeting in February 2025, demonstrating that, as of the January cutoff date, 100% of acute myeloid leukemia ("AML") patients across both the original and RP2D expansion cohorts remain in complete remission ("CR"), with a median follow-up of 20.1 months for AML. Furthermore, these AML patients demonstrated 100% progression-free survival ("PFS") and 100% overall survival ("OS") rates at one-year post transplant, exceeding real-world matched control groups obtained from both the Center for International Blood and Marrow Transplant Research ("CIBMTR") national database, with 67.8% PFS and 74.7% OS at one-year, and from the Kansas University Cancer Center ("KUCC"), 57.4% PFS and 66.7% OS at one-year. KUCC is a tertiary referral center treating primarily intermediate and high-risk patients, and is where the study is currently being conducted. In the second half of 2025, we added The James Comprehensive Cancer Center at Ohio State University as an additional clinical site to accelerate enrollment and increase patient access. Patients treated with INB-100 are demonstrating prolonged and durable remissions supported by peripheral gamma-delta T cell expansion and persistence for one year, the first time this has been observed with an allogenic cellular therapy. In 2024, we held a meeting with the U.S. Food and Drug Administration ("FDA") and received regulatory guidance on a Phase 2 trial of INB-100 for the treatment of AML with PFS as the primary endpoint in a randomized controlled trial. To further de-risk this registrational pathway, we are currently enrolling an expansion cohort at the RP2D, with a target of up to an additional 15 patients (for 25 total patients in the INB-100 Phase 1 trial), to confirm the improvements in relapse free and OS observed to date. We expect to complete the enrollment of the expansion cohort by year-end 2025, or early 2026, with long-term follow-up results anticipated in 2026.
Current wording
INB-100, our first DeltEx allogeneic product candidate, was developed to assess the safety and tolerability of donor-derived manufactured expanded and activated gamma-delta T cells that do not undergo additional genetic modification. The Phase 1 trial of INB-100 has completed primary enrollment and a recommended Phase 2 dose ("RP2D") has been determined. We are currently enrolling an expansion cohort at the RP2D, with a target of an additional 15 patients (for a minimum of 25 total patients in the INB-100 Phase 1 trial), to confirm the improvements in relapse free and OS observed to date. We expect to complete the treatment of all patients, with long-term follow-up results anticipated at a medical meeting in late 2026.
Previous wording
Our DeltEx drug resistant immunotherapy ("DRI") technology is an innovative and proprietary platform that genetically engineers gamma-delta T cells to allow synergistic combinations with conventional standard-of-care chemotherapies for the treatment of solid-tumor cancers. Our proprietary genetic engineering hijacks the tumor’s own resistance mechanism to a chemotherapy to protect our DRI gamma-delta T cells from the killing effects of such chemotherapies. This allows for combination with chemotherapies to drive deeper tumor responses, with the potential for better patient outcomes. Our first indication is newly diagnosed GBM. We have completed patient enrollment and dosing in the Phase 1 investigator-initiated trial of INB-200 (NCT04165941) and we continue to follow patients for PFS and OS. We recently presented an oral plenary presentation at the American Society of Clinical Oncology ("ASCO") Annual Meeting in June 2025 where we provided longer-term patient follow-up. As of June 9, 2025, four patients who received repeated doses of INB-200 remained alive and progression-free with the longest remaining progression-free for over four years. Patients receiving a single dose of INB-200 (cohort 1) had a median progression-free survival ("mPFS") of approximately eight months compared to the expected 6.9 months mPFS in newly diagnosed GBM patients receiving the standard-of-care. Through May 31, 2025, patients who received repeated doses of INB-200 (cohort 2 and 3 combined) demonstrated a mPFS of 16.1 months, a +133% increase in mPFS over the expected 6.9 months mPFS for the standard-of-care Stupp protocol and a doubling in mPFS over the single dose patients. These mPFS results have already surpassed the historical median OS of 14.6 months associated with the SOC Stupp protocol alone. We continue to track the patients as we have not yet reached median OS and expect to provide additional updates at the 2025 Society for Neuro-Oncology ("SNO") Annual Meeting in November of this year.
Current wording
Our DeltEx DRI product candidate, INB-200, is being developed for newly diagnosed GBM. Patient dosing in the investigator-sponsored Phase 1 trial of INB-200 (NCT04165941) has been completed and we continue to follow patients for PFS and OS. In May 2025, we delivered an oral plenary presentation at the American Society of Clinical Oncology ("ASCO") Annual Meeting presenting longer-term patient follow-up data.
Previous wording
INB-400 is the corporate-sponsored investigational new drug application ("IND") for the Phase 2, multi-center clinical trial for our DeltEx DRI technology for the treatment of newly diagnosed GBM. While the IND remains open and we continue to track any enrolled patients, in September 2024, we implemented a pipeline prioritization, suspending enrollment in the Phase 2 trial of INB-400 to conserve cash resources. This trial sought to expand the assessment of genetically modified, DRI gamma-delta T cells in newly diagnosed GBM patients in multiple centers across the United States. We will continue to follow any treated patients for safety, PFS and OS. Preliminary data from patients treated at three additional centers reported mPFS of 10.8 months as of May 31, 2025, with additional data expected to be presented at the 2025 SNO Annual Meeting in November this year. We believe our DeltEx DRI gamma-delta T cell therapeutic approach is demonstrating clinical activity and can be applied to multiple solid tumor types. We are seeking additional funding sources, potential accelerated approval pathways and/or strategic opportunities to potentially partner this program. In April 2023, we received Orphan Drug Designation for the autologous and allogeneic INB-400 products from the FDA, covering a broad range of malignant glioma indications, including relapsed and newly diagnosed GBM.
Current wording
INB-400 is our corporate-sponsored investigational new drug application ("IND") for the Phase 2, multi-center clinical trial evaluating our DeltEx DRI technology in newly diagnosed GBM. Treatment of any enrolled patients has been completed and the IND remains open. In September 2024, following a pipeline prioritization review, we suspended further enrollment in the Phase 2 trial of INB-400 to conserve capital. The trial was designed to further evaluate genetically modified, DRI gamma-delta T cells in newly diagnosed GBM patients across multiple centers in the United States.
Previous wording
We also have a portfolio of preclinical programs in development. These include INB-300, which is applicable to both solid and liquid tumors using a targeted non-signaling gamma-delta T cell based chimeric antigen receptor ("nsCAR") construct, and INB-500, which encompasses our ability to produce gamma-delta T cells from iPSCs. iPSCs represent a significant step toward next generation approaches of cellular manufacturing for true allogeneic and potentially "off-the-shelf" innate cell therapies. We presented additional preclinical data for INB-300, demonstrating our proof-of-concept in vitro studies, run in triplicate, against the leukemia antigen targets CD33 and CD123, at the AACR Annual Meeting in 2024. These data demonstrated the ability of our nsCAR constructs to distinguish between tumor tissue and healthy tissue.
Current wording
We also have a portfolio of preclinical programs within our DeltEx pipeline which currently remain paused in development due to financial market conditions and prioritization. These include INB-300, a targeted non-signaling gamma-delta T cell based chimeric antigen receptor ("nsCAR") construct which is applicable to both solid and liquid tumors, and INB-500, which encompasses our ability to produce gamma-delta T cells from iPSCs.
Previous wording
Since inception in 2016, our operations have focused on identifying and developing potential product candidates, conducting clinical trials, organizing and staffing, business planning, establishing our intellectual property portfolio, raising capital, and providing general and administrative support for these operations. We do not have any product candidates approved for sale and have not generated any revenue. We have funded our operations primarily through the sale of equity and equity-linked securities, including through our initial public offering ("IPO"), follow-on offering, our at-the-market ("ATM") program with Cantor Fitzgerald & Co. ("Cantor Fitzgerald"), and private placements of equity securities.
Current wording
Since inception in 2016, our operations have focused on identifying and developing potential product candidates, conducting clinical trials, organizing and staffing, business planning, establishing our intellectual property portfolio, raising capital, and providing general and administrative support for these operations. We do not have any product candidates approved for sale and have not generated any revenue. We have funded our operations primarily through the sale of equity and equity-linked securities, including through our initial public offering ("IPO"), follow-on offering, our at-the-market ("ATM"), program with Cantor Fitzgerald & Co. ("Cantor Fitzgerald"), and multiple private placements.
Previous wording
We expect to incur additional losses in the future as we advance our product candidates through clinical trials, seek to expand our product candidate portfolio through developing additional product candidates, grow our clinical, regulatory and quality capabilities, and incur costs associated with operating as a public company. Based on our business strategy, our existing cash of $10.7 million as of September 30, 2025 is not anticipated to fund the Company’s projected operating expenses and capital expenditure requirements for a period of at least 12 months from the date of issuance of the unaudited condensed financial statements contained elsewhere in this Quarterly Report, and accordingly, there is substantial doubt about the Company’s ability to continue to operate as a going concern.
Current wording
We expect to incur additional losses in the future as we advance our product candidates through clinical trials, seek to expand our product candidate portfolio through developing additional product candidates, grow our clinical, regulatory and quality capabilities, and incur costs associated with operating as a public company. Based on our business strategy, our existing cash of $21.9 million as of March 31, 2026 is not anticipated to fund our projected operating expenses and capital expenditure requirements for a period of at least 12 months from the date of issuance of the accompanying condensed financial statements, and accordingly, there is substantial doubt about our ability to continue to operate as a going concern.
Previous wording
We continue to deploy cash preservation measures to defer or reduce costs in the near term to preserve capital and increase financial flexibility given the ongoing market environment for biotechnology stocks. These cash preservation measures may impact our ability and the timing to execute our strategy, including our ability to achieve the anticipated milestones and the timing of regulatory filings for our preclinical and clinical programs. To continue to fund our operations, management has developed plans, which primarily consist of the pipeline prioritization announced in September 2024, raising additional capital through some combination of equity and/or debt offerings, including through our ATM program and private placements of securities, and identifying strategic collaborations, licensing or other arrangements to support development of our product candidates. In addition, we may receive aggregate proceeds of up to $12.1 million from the exercise of our outstanding common stock warrants. There is no assurance, however, that we will receive any additional proceeds from the exercise of these warrants or that any additional financing or any revenue-generating collaboration will be available when needed, that we will be able to obtain financing or enter into a collaboration on terms acceptable to us, or that any additional financing or revenue generated through third-party collaborations will be sufficient to fund our operations. If additional capital is not available to us on a timely basis, or at all, we will be required to take additional actions beyond the cost preservation measures initiated to date to address our liquidity needs, including exploring other strategic options, continuing to further reduce operating expense or delaying, reducing the scope of, discontinuing or altering our research and development activities. For additional information, see "—Liquidity and Capital Resources" below.
Current wording
In connection with our private placement completed in December 2025, we may also be eligible to receive up to approximately $20.1 million in additional gross proceeds in exchange for up to 14,579,706 shares of common stock (or, for certain investors, pre-funded warrants in lieu of common stock), subject to the achievement of certain milestone-driven conditions related to preclinical data for our CD19 targeting INB-619 product candidate. In addition, as of March 9, 2026, we may receive an additional $6.7 million in aggregate proceeds if the holders of our Series C warrants exercise their warrants in full. Further, if not otherwise redeemed by us, we may also receive aggregate proceeds of up to $2.3 million from the exercise of our outstanding Series B warrants in full. There is no assurance, however, that we will receive any additional proceeds from the second closing of the 2025 private placement or the exercise of outstanding warrants or pre-funded warrants, that any additional financing or any revenue-generating collaboration will be available when needed, that management will be able to obtain financing or enter into a collaboration on terms acceptable to us, or that any additional financing or revenue generated through third-party collaborations will be sufficient to fund our operations. If additional capital is not available to us on a timely basis, or at all, we will be required to take additional actions beyond the cost preservation measures initiated to date to address our liquidity needs, including exploring other strategic options, continuing to further reduce operating expense or delaying, reducing the scope of, discontinuing or altering our research and development activities. For additional information, see "—Liquidity" below.
Previous wording
The actual amount of cash that we will need to operate is subject to many factors, including those described in the section titled "Risk Factors." The financial statements have been prepared on the basis that we will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty.
Current wording
The actual amount of cash that we will need to operate is subject to many factors, including those described in the section titled "Risk Factors." The condensed financial statements have been prepared on the basis that we will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty.
Previous wording
Research and development activities are central to our business. We expect that our research and development expenses will continue to increase for the foreseeable future as we continue clinical development for our product candidates and continue to discover and develop additional product candidates. If any of our product candidates enter into later stages of clinical development, they will generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.
Current wording
Research and development activities are central to our business. We expect that our research and development expenses will increase in the future as we continue clinical development for our product candidates and continue to discover and develop additional product candidates. If any of our product candidates enter into later stages of clinical development, they will generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.
Previous wording
We expect that our general and administrative expenses will increase for the foreseeable future contingent on additional funding as our organization and headcount needed in the future grow to support continued research and development activities and potential commercialization of our product candidates. These increases will likely include increased costs related to building a team to support our administrative, accounting and finance, communications, legal and business development efforts. In addition, we expect increased expenses associated with being a public company, including costs of additional personnel, accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and SEC requirements; director and officer insurance costs; and investor and public relations costs.
Current wording
We expect that our general and administrative expenses will increase in the future, contingent on additional funding as our organization and headcount needed in the future grow to support continued research and development activities and potential commercialization of our product candidates. These increases will likely include increased costs related to building a team to support our administrative, accounting and finance, communications, legal and business development efforts. In addition, we expect increased expenses associated with being a public company, including costs of additional personnel, accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and SEC requirements; director and officer insurance costs; and investor and public relations costs.
Previous wording
Interest income was $0.1 million and $0 million for the three months ended September 30, 2025 and 2024, respectively.
Current wording
Interest income was $0.2 million and $0.1 million for the three months ended March 31, 2026 and 2025, respectively. The increase was due to additional interest income earned from cash sweep accounts.
Previous wording
We have funded our operations primarily through the sale of equity and equity-linked securities, including through our IPO, follow-on offering, our ATM program and the multiple private placements. Through September 30, 2025, we have raised an aggregate of $143.0 million of gross proceeds from the sale of our securities.
Current wording
We have funded our operations primarily through the sale of equity and equity-linked securities, including through our IPO, follow-on offering, our ATM program and multiple private placements. Through March 31, 2026, we have raised an aggregate of $163.2 million of gross proceeds from the sale of our securities.
Previous wording
After giving effect to the Warrant Exchanges and Warrant Exercises, we may receive up to an aggregate of $8.1 million of gross proceeds from the exercise of the Series C warrants and pre-funded warrants, assuming the exercise in full of all of such warrants for cash. Further, after giving effect to the Warrant Exchanges and Warrant Exercises, if not otherwise redeemed by us, we may also receive aggregate proceeds of up to $4.1 million from the exercise of our outstanding Series B warrants. There is no assurance, however, that we will receive any additional proceeds from exercises of these warrants. See Note 7, Warrants, in our unaudited condensed financial statements contained elsewhere in this Quarterly Report for additional information on our outstanding warrants.
Current wording
In connection with the private placement, completed in December 2025, we may also be eligible to receive up to approximately $20.1 million in additional gross proceeds in exchange for up to 14,579,706 shares of common stock (or, for certain investors, pre-funded warrants in lieu of common stock), subject to the achievement of certain milestone-driven conditions related to preclinical data for our CD19 targeting INB-619 product candidate. In addition, we may receive aggregate proceeds of up to $6.7 million from the exercise of our outstanding pre-funded warrants and Series C warrants, assuming the exercise in full of all of such warrants for cash. Further, if not otherwise redeemed by us, we may also receive aggregate proceeds of up to $2.3 million from the exercise in full of our outstanding Series B warrants. See Note 7, Warrants, in our unaudited condensed financial statements contained elsewhere in this Quarterly Report for additional information on our outstanding warrants. There is no assurance, however, that we will receive any additional proceeds from these warrants or that any additional financing or any revenue-generating collaboration will be available, when needed. If we are unable to raise capital when needed or on acceptable terms, we could be forced to delay, reduce, or explore other strategic options for our research and development programs or other opportunities, or even terminate our operations.
Previous wording
In November 2022, we filed a shelf registration statement on Form S-3 (File No. 333-268288) the ("Shelf Registration Statement") with the SEC, which permits the offering, issuance and sale by us of up to a maximum aggregate offering price of $200 million of our securities, of which $50 million of common stock may be issued and sold pursuant to an ATM program. We entered into a Controlled Equity Offering SM sales agreement (the "Sales Agreement") with Cantor Fitzgerald and Truist, under which Cantor Fitzgerald and Truist agreed to act as our sales agents to sell shares of our common stock, from time to time, through the ATM program. On March 8, 2024, the Company delivered a termination notice to Truist, removing them as a sales agent under the ATM program. Such termination became effective on March 14, 2024. During the three and nine months ended September 30, 2025, we sold an aggregate of 511,057 and 1,815,346 shares of our common stock, respectively, under the ATM program, resulting in net proceeds of approximately $1.1 million and $8.5 million, respectively, after deducting underwriting discounts.
Current wording
In November 2022, we filed a shelf registration statement on Form S-3 (File No. 333-268288) (the "2022 Shelf Registration Statement") with the SEC, which permitted the offering, issuance and sale by us of up to a maximum aggregate offering price of $200 million of our securities, of which $50 million of common stock may be issued and sold pursuant to an ATM program. We entered into a Controlled Equity Offering SM sales agreement (the "Sales Agreement"), with Cantor Fitzgerald and Truist, under which Cantor Fitzgerald and Truist agreed to act as our sales agents to sell shares of our common stock, from time to time, through the ATM program. On March 8, 2024, we delivered a termination notice to Truist, removing them as a sales agent under the ATM program which became effective on March 14, 2024. During the three months ended March 31, 2026, we did not sell any shares of common stock under the ATM program. As of May 4, 2026, $5.9 million remained available for the sale of our common stock under the ATM program.
Previous wording
addressing any potential interruptions, delays and/or cost increases resulting from public health crises, increased interest rates and geopolitical tensions, such as the Israel-Hamas war and the Russia-Ukraine war;
Current wording
addressing any potential interruptions, delays and/or cost increases resulting from public health crises, increased interest rates and geopolitical tensions, such as wars and terrorism;
Previous wording
Additionally, inflationary factors, such as increases in the cost of our clinical trial materials and supplies, interest rates and overhead costs may adversely affect our operating results. Although we do not believe that inflation has had a material impact on our financial position or results of operations to date, we may experience increases in the near future (especially if inflation rates rise) on our operating costs, including our labor costs and research and development costs, due to supply chain constraints, consequences associated with geopolitical tensions such as the Israel-Hamas war and the Russia-Ukraine war, any tariffs enacted by the U.S. government and employee availability and wage increases, which may result in additional stress on our working capital resources.
Current wording
Additionally, inflationary factors, such as increases in the cost of our clinical trial materials and supplies, interest rates, tariffs and overhead costs may adversely affect our operating results. Although we do not believe that inflation has had a material impact on our financial position or results of operations to date, we may experience increased operating costs in the near future (especially if inflation rates rise). Such increases may impact our labor costs and research and development costs, due to supply chain constraints, consequences associated with geopolitical tensions existing and any future tariffs enacted by the U.S. government and employee availability and wage increases, which may result in additional stress on our working capital resources.
Previous wording
If we raise funds through strategic collaboration, licensing or other arrangements, we may relinquish significant rights or grant licenses on terms that are not favorable to us. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions, increases in inflation expectations and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from uncertain economic conditions including inflation expectations and interest rates, bank failures, public health crises such as the COVID-19 pandemic, any potential for avian influenza or similar outbreak and other geopolitical tensions, such as the Israel-Hamas war and the Russia-Ukraine war. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or explore other strategic options for our product development or future commercialization efforts or grant rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves.
Current wording
If we raise funds through strategic collaboration, licensing or other arrangements, we may relinquish significant rights or grant licenses on terms that are not favorable to us. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions, including as a result of increases in inflation and interest rates, disruptions to, and volatility in, the credit and financial markets in the United States, tariffs and trade wars, and other geopolitical tensions, such as wars and terrorism and future U.S. government shutdowns. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or explore other strategic options for our product development or future commercialization efforts or grant rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves.
Previous wording
Our material cash requirements as of September 30, 2025 included operating lease commitments, including the lease of our current headquarters office in New York, New York, laboratory and office space in Birmingham, Alabama and a manufacturing service agreement with a third party to engage in research of cell therapy products. In April 2025, we terminated our operating lease for additional unutilized office space in Birmingham, Alabama. We paid a one-time termination fee of $0.1 million, and paid five monthly payments of $20,000, beginning June 1, 2025. As of October 1, 2025, there are no additional payments due. See Note 12, Equipment and Facility Leases, in our unaudited condensed financial statements contained elsewhere in this Quarterly Report for additional information. As of September 30, 2025, we had fixed lease payment obligations of $3.6 million, with $1.2 million payable within 12 months.
Current wording
Our material cash requirements as of March 31, 2026 included operating lease commitments, including the lease of our current headquarters office in New York, New York, laboratory and office space in Birmingham, Alabama and a manufacturing service agreement with a third party to engage in research of cell therapy products. See Note 12, Equipment and Facility Leases, in our unaudited condensed financial statements contained elsewhere in this Quarterly Report for additional information. As of March 31, 2026, we had fixed lease payment obligations of $2.8 million, with $1.3 million payable within 12 months.
Previous wording
Cash used in operating activities was $20.1 million during the nine months ended September 30, 2024, primarily due to our net loss of $24.3 million and changes in operating assets and liabilities of $2.2 million, partially offset by an increase in non-cash charges of $6.1 million. Decreases in our operating assets and liabilities consisted primarily of $2.2 million in accrued expenses and other current liabilities relating primarily to accrued compensation, accrued clinical trials, and accrued legal, $0.7 million in long-term operating liabilities, partially offset by an increase of $0.2 million in accounts payable. Increases in our non-cash charges consisted primarily of $4.2 million in stock-based compensation due to the acceleration in full of outstanding unvested stock options as a result of our workforce reduction in September 2024, $1.2 million in amortization of right-of-use assets associated with our operating and finance leases for the period, and $0.7 million of depreciation.
Current wording
Cash used in operating activities was $4.9 million during the three months ended March 31, 2026, primarily due to our net loss of $5.1 million and changes in operating assets and liabilities of $0.7 million, partially offset by an increase in non-cash charges of $0.9 million. Decreases in our operating assets and liabilities consisted primarily of $0.9 million in accrued expenses and other current liabilities relating primarily to accrued compensation, accrued clinical trials, and accrued legal, partially offset by increases of $0.1 million in prepaid expenses and other current assets and $0.1 million in accounts payable. Increases in our non-cash charges consisted primarily of $0.4 million in stock-based compensation, $0.3 million in amortization of right-of-use assets associated with our operating and finance leases for the period and $0.2 million of depreciation.
Previous wording
Cash used in operating activities was $10.6 million during the nine months ended September 30, 2025, primarily due to our net loss of $14.5 million and changes in operating assets and liabilities of $0.5 million, partially offset by non-cash charges of $4.4 million. Increases in our operating assets and liabilities consisted primarily of $0.4 million in prepaid expenses and other current assets and $0.1 million in non-current assets, partially offset by decreases of $0.6 million in accrued expenses and other current liabilities relating primarily to accrued compensation, accrued clinical trials, and accrued legal, $0.2 million in accounts payable and $0.2 million in net operating lease liabilities. Non-cash charges consisted primarily of $2.5 million in stock-based compensation, $1.2 million in amortization of right-of-use assets associated with our operating and finance leases for the period and $0.8 million of depreciation.
Current wording
Cash used in operating activities was $3.1 million during the three months ended March 31, 2025, primarily due to our net loss of $5.6 million, partially offset by an increase in non-cash charges of $1.5 million and changes in operating assets and liabilities of $0.7 million. Increases in our operating assets and liabilities consisted primarily of $0.6 million in prepaid expenses and other current assets and $0.2 million in accounts payable, partially offset by decreases of $0.1 million in accrued expenses and other current liabilities relating primarily to accrued compensation, accrued clinical trials, and accrued legal. Increases in our non-cash charges consisted primarily of $0.8 million in stock-based compensation, $0.4 million in amortization of right-of-use assets associated with our operating and finance leases for the period and $0.3 million of depreciation.
Previous wording
Cash provided by financing activities was $10.1 million during the nine months ended September 30, 2025, primarily due to $8.4 million in net proceeds received from our ATM program and $2.3 million in proceeds from the exercise of warrants, partially offset by $0.6 million in principal payments of finance leases.
Current wording
Cash provided by financing activities was $3.9 million during the three months ended March 31, 2025, primarily due to $3.7 million in net proceeds received from our ATM program and $0.4 million in proceeds from Series C warrants exercised, partially offset by $0.2 million in principal payments of finance leases.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
We continue to maintain cash preservation measures to defer or reduce costs in the near term in order to preserve capital and increase financial flexibility given the ongoing market environment for biotechnology stocks. These cash preservation measures may impact our ability and the timing to execute our strategy, including our ability to achieve the anticipated milestones and the timing of regulatory filings for our preclinical and clinical programs. To continue to fund our operations, management has developed plans, which primarily consist of the pipeline prioritization, raising additional capital through some combination of equity and/or debt offerings, including through our ATM program, and identifying strategic collaborations, licensing or other arrangements to support development of our product candidates.
Current report — wording carried from elsewhere
As of March 31, 2026, we had cash of $21.9 million, which is only expected to fund our projected operating expenses and capital expenditure requirements through April 2027. We continue to deploy cash preservation measures to defer or reduce costs in the near term in order to preserve capital and increase financial flexibility. These cash preservation measures may impact our ability and the timing to execute our strategy, including our ability to achieve the anticipated milestones and the timing of regulatory filings for our preclinical and clinical programs. To continue to fund our operations, management has developed plans, which primarily consist of the pipeline prioritization, raising additional capital through some combination of equity and/or debt offerings, including through our ATM program, and identifying strategic collaborations, licensing or other arrangements to support development of our product candidates.
Current report — wording carried from elsewhere
In November 2025, we filed a shelf registration statement on Form S-3 (File No. 333-291393) (the "2025 Shelf Registration Statement") with the SEC, which would permit the offering, issuance and sale by us of up to a maximum aggregate offering price of $200 million of our securities and which has not yet been declared effective, to replace the expiring 2022 Shelf Registration Statement. The 2022 Shelf Registration Statement will remain in effect until the earlier of May 20, 2026 and the effective date of the 2025 Shelf Registration Statement.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
The following table sets forth our results of operations for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous report — wording carried elsewhere
The following table summarizes our research and development expenses for the nine months ended September 30, 2025 and 2024 (in thousands):