INB 200(IN8bio)

NEW YORK, May 13, 2024 (GLOBE NEWSWIRE) -- IN8bio (Nasdaq: INAB), a clinical-stage biopharmaceutical company advancing innovative gamma-delta T cell therapies, presented in an oral session details about its robust and reproducible proprietary clinical-scale gamma-delta T cell manufacturing platform across different donor populations, at the American Society of Gene & Cell Therapy (ASGCT) 2024 Annual Meeting. In an oral presentation titled: “Healthy Donor vs. Patient Manufactured Autologous DeltEx DRI Product; Immunophenotyping Gene Expression,” IN8bio provided novel characterization data demonstrating the reproducibility and robust cellular properties of its clinical-scale manufactured investigational products. These data demonstrate that the manufacturing process results in investigational products with upregulated markers of potency, effector functions and trafficking capabilities, which IN8bio believes represents a significant advancement in the characterization of gamma-delta T cell-based therapies. “The data presented provide additional insight on the complex gene-expression changes that occur throughout the manufacturing of our gamma-delta T cell products, which demonstrate a consistent profile at the end of manufacturing,” said Dr. Kate Rochlin, Chief Operating Officer of IN8bio. “These new insights into the potency, effector functions, and trafficking changes that occur from initiation to the end of manufacturing in our gamma-delta T cells underscores the reproducibility and robustness of our manufacturing process. The data suggests that the characteristics of the final product are driven more by the manufacturing process than individual donor profiles. We seek to understand how key molecular characteristics allow the optimization of these unique therapies for potentially improved clinical outcomes.” The study evaluated T cell receptor repertoire and gene-expression changes from apheresis starting material through to final manufactured gamma-delta T cell products, from healthy donors and glioblastoma (GBM) patients enrolled in the INB-200 Phase 1 clinical trial (NCT04165941). The gamma-delta T cell products demonstrated significant increases in markers of cellular activation and cytotoxicity, with enhanced expression of immune trafficking and stimulation markers, suggesting the potential for potent killing, tissue trafficking and immune cell recruitment in vivo. The data also revealed highly similar gene expression profiles between gamma-delta T cell products manufactured from healthy volunteers and GBM patients, demonstrating the robustness and reproducibility of the manufacturing process across different donor populations. About IN8bio IN8bio is a clinical-stage biopharmaceutical company developing gamma-delta T cell-based immunotherapies for cancer patients. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. The company’s lead program INB-400 is in a Phase 2 trial in GBM. Additional programs include Phase 1 trials in solid and hematologic tumors, including INB-200 for GBM and INB-100 for patients with hematologic malignancies undergoing transplantation. For more information about IN8bio, visit www.IN8bio.com. Forward-Looking StatementsThis press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding IN8bio’s ability to optimize unique therapies for potentially improved clinical outcomes as a result of its manufacturing processes; and the potential IN8bio’s gamma-delta T cell products to be utilized for tissue trafficking and immune cell recruitment in vivo. IN8bio may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of IN8bio’s product candidates, including patient enrollment and follow-up and IN8bio’s ability to meet anticipated deadlines and milestones; the risk that IN8bio may not realize the intended benefits of its DeltEx platform; availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of IN8bio’s product candidates; uncertainties related to regulatory approvals to conduct trials or to market products; IN8bio’s reliance on third parties, including licensors and clinical research organizations; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, that are described in greater detail in the section entitled “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 9, 2024, as well as in other filings IN8bio may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and IN8bio expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances, or otherwise, except as otherwise required by law. Corporate Contact: IN8bio, Inc.Glenn Schulman, PharmD, MPH203.494.7411gdschulman@IN8bio.com Investors Meru AdvisorsLee M. Sternlstern@meruadvisors.com Media Contact Kimberly HaKKH Advisors917.291.5744kimberly.ha@kkhadvisors.com

- Presented new preclinical data demonstrating proof-of-concept for non-signaling Chimeric Antigen Receptor (nsCAR) platform to effectively target cancer cells while preserving healthy tissue - Demonstrated potential of nsCAR platform to treat previously “undruggable” solid and liquid tumor targets - Announced peer-reviewed publication in ‘Frontiers in Immunology’ on IN8bio’s DeltEx Drug Resistant Immunotherapy (DRI) approach to newly diagnosed glioblastoma multiforme (GBM) - Dosed first patient in autologous arm of INB-400 Phase 2 clinical trial for patients with newly diagnosed GBM NEW YORK, May 09, 2024 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today reported financial results for the first quarter ended March 31, 2024 and recent corporate highlights. “We continued to make significant progress advancing our gamma-delta T cell programs in the first quarter of 2024,” said William Ho, CEO and co-founder of IN8bio. “We presented new preclinical data on our nsCAR platform at the American Association for Cancer Research (AACR) 2024 Annual Meeting demonstrating its potential to target and kill various acute myeloid leukemia (AML) cells by targeting CD33 and/or CD123, while preserving healthy bone marrow cells. These findings reinforce our technology’s ability to precisely target “undruggable” cancer targets that have historically been challenging due to on-target, off-tumor toxicity. We will provide an update from our Phase 1 study of INB-100 at the 2024 European Hematology Association (EHA) Annual Meeting in June, including patient status and survival rate data. We anticipate enrolling ten additional patients in an expansion cohort at the recommended Phase 2 dose, and could potentially submit an investigational new drug (IND) application for a Phase 2 randomized control trial this year. In addition, at the American Society of Clinical Oncology (ASCO) Annual Meeting, we will provide an update on our Phase 1 INB-200 study in GBM which generated an initial efficacy signal supporting the INB-400 trial.” Corporate Highlights and Recent Developments Presented data at AACR 2024, supporting the potential of proprietary constructs targeting CD33 and/or CD123 for in vitro evaluation against various types of leukemia, including AML and chronic myeloid leukemia (CML). Demonstrated significant differences between cells expressing traditional signaling chimeric antigen receptors (CARs) and those expressing nsCAR constructs, which include a reduction in activation-induced cell death with nsCAR constructs. Peer-reviewed publication of “Adoptive Cell Therapy for High Grade Gliomas using Simultaneous Temozolomide and Intracranial MGMT-Modified γδ T cells Following Standard Post-Resection Chemotherapy and Radiotherapy: Current Strategy and Future Directions” in Frontiers in Immunology detailing IN8bio’s DeltEx Drug Resistant Immunotherapy (DRI) as a rational therapeutic approach for newly diagnosed GBM.Announced first patient dosed in the Phase 2 autologous arm of INB-400 in patients with newly diagnosed GBM. Upcoming Anticipated Pipeline Milestones and Events American Society of Gene & Cell Therapy (ASGCT) 2024 Annual Meeting (May 10, 2024): Upcoming oral presentation: “Healthy Donor vs Patient Manufactured Autologous DeltEx DRI Product; Immunophenotyping Gene Expression,” will unveil new data highlighting the characterization of our clinical manufactured DeltEx DRI product. The presentation will explore the impact of manufacturing on the final cell product from healthy donors and those manufactured from cancer patients, showcasing IN8bio’s robust capabilities and know-how in complex cell therapy process development and manufacturing.INB-100: Report updated interim results from the ongoing Phase 1 investigator-sponsored trial at the 2024 EHA Annual Meeting, held June 13-16 in Madrid, Spain. In addition, we will potentially submit an IND application for a Phase 2 registrational trial in 2024 in the AML and myelodysplastic syndrome (MDS) patient setting.INB-200: Report interim Phase 1 long-term follow up results in GBM at multiple medical meetings in 2024 including at the 2024 ASCO Annual Meeting.INB-400: Initiated patient dosing in the Phase 2 autologous arm of INB-400 in newly diagnosed GBM. IN8bio expects to treat up to a total of 40 patients in arm A at multiple sites across the United States. First Quarter 2024 Financial Highlights Research and Development (R&D) expenses: R&D expenses were $4.9 million, compared to $4.4 million for the comparable prior year period. The increase was primarily due to (i) increased personnel-related costs, including salaries and stock-based compensation due to increased headcount and (ii) direct clinical costs for INB-100, INB-200 and INB-400.General and administrative expenses: General and administrative expenses were $3.7 million, compared to $3.5 million for the comparable prior year period. The increase was primarily due to increased personnel-related costs, including stock-based compensation and rent, offset by cost savings related to directors’ and officers’ insurance premiums and a reduction in professional services.Net loss: Net loss was $8.6 million, or $0.20 per basic and diluted common share, compared to a net loss of $7.5 million, or $0.30 per basic and diluted common share, for the comparable prior year period.Cash position: As of March 31, 2024, the Company had cash of $13.0 million, compared to $21.3 million, as of December 31, 2023. About IN8bio IN8bio is a clinical-stage biopharmaceutical company developing gamma-delta T cell-based immunotherapies for cancer patients. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. The company’s lead program INB-400 is in a Phase 2 trial in glioblastoma multiforme (GBM). Additional programs include Phase 1 trials in solid and hematologic tumors, including INB-200 for GBM and INB-100 for patients with hematologic malignancies undergoing transplantation. For more information about IN8bio, visit www.IN8bio.com. Forward Looking StatementsThis press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: IN8bio’s ability to continue advancing our gamma-delta T-cell programs; the potential of IN8bio’s proprietary nsCAR platform to selectively eliminate cancer cells while preserving healthy tissue; and IN8bio’s ability to achieve anticipated milestones, including expected presentations and data readouts from its trials, enrollment of additional patients in its clinical trials, advancement of clinical development plans and submission of INDs. IN8bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as IN8bio’s ability to meet anticipated deadlines and milestones, presented by public health crises as well as rising inflation and regulatory developments; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of IN8bio’s product candidates; the risk that IN8bio may not realize the intended benefits of its DeltEx platform; availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of IN8bio’s product candidates; expectations for regulatory approvals to conduct trials or to market products; IN8bio’s reliance on third parties, including licensors and clinical research organizations; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 14, 2024, as well as in other filings IN8bio may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and IN8bio expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. IN8BIO, INC.CONDENSED BALANCE SHEETS(In thousands, except share and per share data) March 31, 2024 December 31, (unaudited) 2023 Assets Current assets Cash $13,015 $21,282 Prepaid expenses and other current assets 2,740 3,343 Total Current Assets 15,755 24,625 Non-current assets Property and equipment, net 3,325 3,514 Construction in progress 203 182 Restricted cash 256 256 Right-of-use assets - finance leases 1,160 1,364 Right-of-use assets - operating leases 4,530 3,513 Other non-current assets 320 255 Total Non-Current Assets 9,794 9,084 Total Assets $25,549 $33,709 Liabilities and Stockholders' Equity Liabilities Current liabilities Accounts payable $1,413 $924 Accrued expenses and other current liabilities 895 2,955 Short-term finance lease liability 680 694 Short-term operating lease liability 856 820 Total Current Liabilities 3,844 5,393 Long-term finance lease liability 351 525 Long-term operating lease liability 3,828 2,854 Total Non-Current Liabilities 4,179 3,379 Total Liabilities 8,023 8,772 Stockholders' Equity Preferred stock, par value $0.0001 per share; 10,000,000 shares authorized at March 31, 2024 and December 31, 2023, respectively. No shares issued and outstanding — — Common stock, par value $0.0001 per share; 490,000,000 shares authorized at March 31, 2024 and December 31, 2023; 43,287,325 shares issued and outstanding at March 31, 2024 and December 31, 2023 4 4 Additional paid-in capital 117,303 116,152 Accumulated deficit (99,781) (91,219)Total Stockholders' Equity 17,526 24,937 Total Liabilities and Stockholders' Equity $25,549 $33,709 IN8BIO, INC. CONDENSED STATEMENTS OF OPERATIONS (In thousands, except share and per share data) (Unaudited) Three Months EndedMarch 31, 2024 2023 Operating expenses: Research and development$4,903 $4,385 General and administrative 3,742 3,470 Total operating expenses 8,645 7,855 Interest income 83 — Other income — 330 Loss from operations (8,562) (7,525)Net loss$(8,562) $(7,525)Net loss per share – basic and diluted$(0.20) $(0.30)Weighted-average number of shares used in computing net loss per common share, basic and diluted 43,287,325 24,732,580 Corporate Contact: IN8bio, Inc.Glenn Schulman, PharmD, MPH203.494.7411gdschulman@IN8bio.com Investors Meru AdvisorsLee M. Sternlstern@meruadvisors.com Media Contact Kimberly HaKKH Advisors917.291.5744kimberly.ha@kkhadvisors.com