IN8BIO, INC.

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 ─ 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 tumor and targeted 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 tested 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 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.

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 original and 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. 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 in 2025, 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 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.

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 4 years. Patients receiving a single dose of INB-200 (cohort 1) had a median progression-free survival ("mPFS") of approximately 8 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 later this year.

Current 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.

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 treat 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. During our conference call following the 2025 ASCO Annual Meeting, preliminary data from patients treated at three additional centers reported mPFS of 10.8 months as of May 31, 2025, with additional data expected later 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 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 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.

Previous wording

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 the expansion and activation of gamma-delta T cells to potentially offer a sustained and potent anti-tumor 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 target depletion for potential applications in autoimmune diseases. Unlike traditional TCEs, which can cause cytokine release syndrome ("CRS") and T cell exhaustion by broadly activating all T cells, our INB-600 TCE platform selectively activates gamma-delta T cells, including both V delta 1+ and V delta 2+ (Vd1+ and Vd2+) gamma-delta T cell subsets, leveraging their innate ability to recognize tumors with minimal risk of CRS. The pan activation and expansion of both the Vd1+ and Vd2+ gamma-delta T cell compartments further broadens our therapeutic potential, combining the rapid antigen presentation, immune activation and phagocytosis capabilities of Vd2+ cells with the more persistent durability and tissue residence properties of Vd1+ cells, with the goal of driving deeper responses and eliminate cancers or pathogenic B cells associated with autoimmune disease.

Current wording

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 wording

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 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.

Current wording

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 wording

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.

Current wording

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 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 the Private Placements (as defined below).

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 private placements of equity securities.

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 $13.2 million as of June 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 these condensed financial statements, 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 $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.

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 and workforce reduction, 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. In addition, as of June 30, 2025, we may receive an additional $1.7 million and $8.1 million in aggregate proceeds if the holders of our Series A warrants and Series C warrants exercise their warrants, respectively. Further, 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 the Private Placements or 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 and Capital Resources" below.

Current 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.

Previous wording

We expense research and development costs as incurred. Costs for external development activities are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our vendors. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our financial statements as prepaid or accrued research and development expenses. We allocate our direct external research and development costs across each product candidate. Preclinical expenses consist of external research and development costs associated with activities to support our current and future clinical programs but are not allocated by product candidate due to the overlap of the potential benefit of those efforts across multiple product candidates.

Current wording

We expense research and development costs as incurred. Costs for external development activities are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our vendors. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our condensed financial statements as prepaid or accrued research and development expenses. We allocate our direct external research and development costs across each product candidate. Preclinical expenses consist of external research and development costs associated with activities to support our current and future clinical programs but are not allocated by product candidate due to the overlap of the potential benefit of those efforts across multiple product candidates.

Previous wording

Research and development expenses were $2.5 million for the three months ended June 30, 2025, compared to $5.2 million for the comparable prior year period. These amounts include non-cash items such as stock-based compensation ("SBC") and depreciation of $0.5 million. The decrease of $2.7 million was primarily due to a $1.3 million decrease in personnel-related costs, including salaries and SBC as a result of the decrease in our headcount. Direct clinical costs decreased by $1.4 million due to decreased costs for INB-200 and INB-400.

Current wording

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 wording

General and administrative expenses were $2.7 million for the three months ended June 30, 2025, compared to $3.5 million for the comparable prior year period. These amounts include non-cash items such as SBC and depreciation of $0.7 million. 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.

Current wording

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 wording

Interest income was $0.1 million for the three months ended June 30, 2025 and 2024.

Current wording

Interest income was $0.1 million and $0 million for the three months ended September 30, 2025 and 2024, respectively.

Previous wording

The following table sets forth our results of operations for the six months ended June 30, 2025 and 2024 (in thousands):

Current wording

The following table sets forth our results of operations for the nine months ended September 30, 2025 and 2024 (in thousands):

Previous wording

The following table summarizes our research and development expenses for the six months ended June 30, 2025 and 2024 (in thousands):

Current wording

The following table summarizes our research and development expenses for the nine months ended September 30, 2025 and 2024 (in thousands):

Previous wording

Research and development expenses were $5.5 million for the six months ended June 30, 2025, compared to $10.1 million for the comparable prior year period. These amounts include non-cash items such as SBC and depreciation of $1.1 million. The decrease of $4.6 million was primarily due to a $2.6 million decrease in personnel-related costs, including salaries and SBC as a result of the decrease in our headcount. Direct clinical costs decreased by $2.0 million due to decreased costs for INB-200 and INB-400.

Current wording

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 wording

General and administrative expenses were $5.4 million for the six months ended June 30, 2025, compared to $7.3 million for the comparable prior year period. These amounts include non-cash items such as SBC and depreciation of $1.2 million. The decrease of $1.9 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.

Current wording

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 wording

Interest income was $0.2 million for the six months ended June 30, 2025 and 2024.

Current wording

Interest income was $0.3 million and $0.2 million for the nine months ended September 30, 2025 and 2024, respectively.

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 June 30, 2025, we have raised an aggregate of $139.6 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 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.

Previous wording

As of June 30, 2025, we had cash of $13.2 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-400 and our earlier stage assets. Based on this business strategy, our existing cash as of June 30, 2025 is only expected to fund the 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 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.

Current wording

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 wording

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 (the “2025 Pre-Funded Warrants”), 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 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.

Current wording

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 wording

In April 2025, we entered into an Amendment No. 1 (the “SPA Amendment”) to Securities Purchase Agreement, dated September 30, 2024 (the “2023 Purchase Agreement”), to amend the restrictions on certain equity sales by us set forth in the 2023 Purchase Agreement. 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 (the “Amended Series B warrants”), to the extent such warrants were not exercised pursuant to the Warrant Exercises or exchanged pursuant to the Warrant Exchanges.

Current wording

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 wording

As of June 30, 2025, we had issued and outstanding 248,382 pre-funded warrants, 129,296 Series A warrants (subject to amendment as described below), 303,574 Series B Warrants, and 997,638 Series C warrants. 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 and (ii) exchange certain Series A warrants and Series B warrants for 41,014 Pre-Funded Warrants, for aggregate net proceeds of $1.9 million.

Current wording

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 wording

After giving effect to the Warrant Exchanges and Warrant Exercises, we may receive up to an aggregate of $9.8 million of gross proceeds from the exercise of the Series A warrants, 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 Amended Series B 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. 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

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.

Previous wording

In November 2022, we filed a shelf registration statement on Form S-3 (File No. 333-268288), or 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 six months ended June 30, 2025, we sold an aggregate of 1,058,861 and 1,304,289 shares of our common stock under the ATM program, resulting in net proceeds of approximately $3.6 million and $7.4 million after deducting underwriting discounts.

Current 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.

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, uncertainties arising as a result of the change in U.S. federal administration, 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, 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.

Previous wording

Our material cash requirements as of June 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 will pay five monthly payments of $20,000, beginning June 1, 2025. See Note 12, Equipment and Facility Leases, for additional information. As of June 30, 2025, we had fixed lease payment obligations of $3.8 million, with $1.4 million payable within 12 months.

Current 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.

Previous wording

Cash used in operating activities was $7.0 million during the six months ended June 30, 2025, primarily due to our net loss of $10.6 million, partially offset by non-cash charges of $3.2 million and changes in operating assets and liabilities of $0.3 million. Increases in our operating assets and liabilities consisted primarily of $0.9 million in prepaid expenses and other current assets, partially offset by decreases of $0.5 million in accrued expenses and other current liabilities relating primarily to accrued compensation, accrued clinical trials, and accrued legal, and $0.1 million in operating lease liabilities. Non-cash charges consisted primarily of $1.8 million in stock-based compensation, $0.9 million in amortization of right-of-use assets associated with our operating and finance leases for the period and $0.5 million of depreciation.

Current 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.

Previous wording

Cash used in operating activities was $14.0 million during the six months ended June 30, 2024, primarily due to our net loss of $17.2 million and changes in operating assets and liabilities of $0.5 million, partially offset by non-cash charges of $3.7 million. Decreases in our operating assets and liabilities consisted primarily of $1.4 million in accrued expenses and other current liabilities relating primarily to accrued compensation, accrued clinical trials, and accrued legal and $0.5 million in long-term operating liabilities, partially offset by an increase of $0.9 million in prepaid expenses and other current assets and $0.5 million in accounts payable. Non-cash charges consisted primarily of $2.4 million in stock-based compensation due to increased employee headcount resulting from growth in our business, $0.8 million in amortization of right-of-use assets associated with our operating and finance leases for the period and $0.5 million of depreciation.

Current 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.

Previous wording

Cash used in investing activities was $- million during the six months ended June 30, 2025.

Current wording

Cash used in investing activities was nil during the nine months ended September 30, 2025.

Previous wording

Cash used in investing activities was $0.2 million during the six months ended June 30, 2024, primarily due to purchases of property and equipment and construction in progress activity in relation to capitalized software.

Current wording

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 wording

Cash provided by financing activities was $9.2 million during the six months ended June 30, 2025, primarily due to $7.4 million in net proceeds received from our ATM program, $2.3 million in warrants exercised, partially offset by $0.5 million in principal payments of finance leases.

Current 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.

Previous wording

Cash provided by financing activities was $3.1 million during the six months ended June 30, 2024, primarily due to proceeds received from the issuance and sale of common stock pursuant to the ATM program of $3.6 million, partially offset by principal payments of $0.4 million on our leases and $0.1 million of issuance costs.

Current wording

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 wording

As part of the process of preparing our financial statements, we are required to estimate our accrued research and development expenses. We make estimates of our accrued expenses as of each balance sheet date in the financial statements based on facts and circumstances known to us at that time. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the expense. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, we adjust the accrual or the amount of prepaid expenses accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, there have not been any material adjustments to our prior estimates of accrued research and development expenses.

Current wording

As part of the process of preparing our financial statements, we are required to estimate our accrued research and development expenses. We make estimates of our accrued expenses as of each balance sheet date in the condensed financial statements based on facts and circumstances known to us at that time. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the expense. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, we adjust the accrual or the amount of prepaid expenses accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, there have not been any material adjustments to our prior estimates of accrued research and development expenses.

Previous wording

During the six months ended June 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.

Current wording

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 wording

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 fiscal year ending December 31, 2025.

Current wording

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.