MGMT

Reported the First-Ever Durable Persistence of an Allogeneic Cellular Therapy from a Phase 1 Study of INB-100 in Leukemia where 100% of Evaluable Patients (n=10) Treated Remained in Remission, including six Patients Alive and Progression Free Past 12 Months Presented Positive Results from a Phase 1 Study in Newly Diagnosed Glioblastoma (GBM) Demonstrating All Patients Treated with INB-200 Exceeded Progression-Free Survival (PFS) of Seven Months at the Society for Neuro-Oncology (SNO) 28th Annual MeetingAppointed Dr. Corinne Epperly, M.D., M.P.H. to Board of DirectorsClosed Private Placement in December 2023 with Initial Gross Proceeds of $14.4 Million to Provide Cash Runway into 1Q 2025 NEW YORK, March 14, 2024 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today reported financial results and business highlights for the fourth quarter and full-year ended December 31, 2023. “IN8bio entered 2024 with significant momentum behind the company,” said William Ho, CEO and co-founder of IN8bio. “Despite the difficult environment in 2023, the IN8bio team executed operationally and successfully advanced our programs. We presented positive data across our major clinical programs in leukemia and GBM, broadened our clinical portfolio, and strengthened our financial position by securing funding into 1Q 2025. We presented updated data from our INB-100 study at the 65th American Society of Hematology Annual Meeting, which was the first time any allogeneic cellular therapy has reported sustained efficacy and long-term cell persistence through 365 days. This showcases the potential of gamma-delta T cells to provide long-term durable remissions for patients with leukemia. We believe that IN8bio is well-positioned for significant near- and long-term catalysts as we advance our pipeline of gamma-delta T cell therapies to potentially extend survival in some of the most aggressive forms of cancer.” Business Highlights and Recent Developments Announced positive INB-100 data at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition demonstrating that 100% of evaluable leukemia patients (n=10) treated remained alive, progression-free, and in durable complete remission (CR) as of November 3, 2023. The data showed long-term in-vivo expansion and persistence of allogeneic gamma-delta T cells 365 days following a single administration of INB-100. The study demonstrated the first-ever durable persistence of an allogeneic cellular therapy.Reported positive data on INB-200 at the 28th SNO Annual Meeting. All patients who completed mandated doses surpassed a median PFS of seven months, exceeded the standard-of-care median PFS of four to seven months, with one patient in Cohort 2 remaining alive and progression free past 28.5 months as of October 20, 2023. In addition, most patients exceeded the expected PFS based on their age and methylguanine-DNA methyltransferase (MGMT) status of their tumors.Announced a private placement totaling up to $46.9 million in potential gross proceeds. The initial closing of $14.4 million is expected to support operational execution and extended the Company’s cash runway into 1Q 2025 with the potential for up to $32.5 million in additional capital at increasing valuations, subject to certain conditions.Initiated enrollment for the Phase 2 study of INB-400 in newly diagnosed GBM.Announced publication in Frontiers in Immunology on IN8bio’s DeltEx Drug Resistant Immunotherapy (DRI) as a rational therapeutic approach to newly diagnosed glioblastoma titled, “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.”Appointed Dr. Corinne Epperly, M.D., M.P.H., an internationally recognized immuno-oncology and cell therapy executive with 20 years of experience, to the Board of Directors. Upcoming Anticipated Pipeline Milestones and Events INB-100: Enroll an additional 10 patients in an expansion cohort at the recommended Phase 2 dose (RP2D) and report Phase 1 long-term follow-up results at multiple medical meetings throughout 2024; potentially submit investigational new drug (IND) application for Phase 3 randomized control trial in 2024.INB-200: Report Phase 1 long-term follow up results at multiple medical meetings in 2024.INB-300: Present additional preclinical data demonstrating proof-of-concept for the nsCAR platform targeting CD33 and CD123 at the American Association for Cancer Research (AACR) Annual Meeting in April 2024.INB-400: Dose first patient and treat up to 15 patients at multiple sites across the United States in the Phase 2 trial in newly diagnosed GBM; potentially submit IND for Phase 1b allogeneic gamma-delta T cell study in relapsed GBM in 2024. Fourth Quarter and Full Year 2023 Financial Highlights Research and Development (R&D) expenses: R&D expenses were $4.5 million for the three months ended December 31, 2023, compared to $4.0 million for the comparable prior year period. R&D expenses were $16.8 million for the year ended December 31, 2023, compared to $14.1 million in the prior year. The increase in R&D expenses was primarily due to increased personnel-related costs, including salaries, benefits, and non-cash stock-based compensation due to increased headcount, as well as increased third-party clinical trial-related activities for the INB-100 and INB-200 programs. The increase was partially offset by a reduction in contract research organization expenses for INB-400 related to the IND filing in the prior year.General and administrative (G&A) expenses: G&A expenses were $3.1 million for the three months ended December 31, 2023, compared to $3.9 million for the comparable prior year period. G&A expenses were $13.5 million for the year ended December 31, 2023, compared to $14.5 million in the prior year. The decrease in G&A expenses was primarily due to cost savings related to D&O insurance premiums and reductions in professional services.Net loss: The company reported a net loss of $7.6 million, or $0.22 per basic and diluted common share, for the three months ended December 31, 2023, compared to a net loss of $7.8 million, or $0.32 per basic and diluted common share, for the comparable prior year period. For the year ended December 31, 2023, net loss was $30.0 million, or $1.00 per basic and diluted common share, compared to a net loss of $28.5 million, or $1.36 per basic and diluted common share, for the prior year.Cash position: As of December 31, 2023, the Company had cash of $21.3 million, compared to $18.2 million as of December 31, 2022. 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 extending IN8bio’s cash runway into January 2025; IN8bio’s ability to receive additional capital from the December 2023 private placement and the corresponding impact on the company’s cash runway; IN8bio’s ability to achieve significant near- and long-term growth; IN8bio’s ability to advance its pipeline of gamma-delta T cell therapies to potentially extend survival in some of the most aggressive forms of cancer; the timing of initiation, progress and scope of clinical trials for IN8bio’s product candidates, including INB-100, INB-200, INB-300 and INB-400; and IN8bio’s ability to achieve anticipated milestones, including expected 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 9, 2023, 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.Balance Sheets (In thousands, except share and per share data) December 31, December 31, 2023 2022 Assets Current assets Cash$21,282 $18,182 Prepaid expenses and other current assets 3,343 4,052 Total Current Assets 24,625 22,234 Non-current assets Property and equipment, net 3,514 4,397 Construction in progress 182 29 Restricted cash 256 252 Right-of-use assets - finance leases 1,364 1,691 Right-of-use assets - operating leases 3,513 4,181 Other non-current assets 255 255 Total Non-Current Assets 9,084 10,805 Total Assets$33,709 $33,039 Liabilities and Stockholders' Equity Liabilities Current liabilities Accounts payable$924 $2,091 Accrued expenses and other current liabilities 2,955 2,342 Short-term finance lease liability 694 682 Short-term operating lease liability 820 707 Total Current Liabilities 5,393 5,822 Long-term finance lease liability 525 811 Long-term operating lease liability 2,854 3,674 Total Non-Current Liabilities 3,379 4,485 Total Liabilities 8,772 10,307 Commitments and Contingencies Stockholders' Equity Preferred stock, par value $0.0001 per share; 10,000,000 shares authorized at December 31, 2023 and 2022. No shares issued and outstanding — — Common stock, par value $0.0001 per share; 490,000,000 shares authorized at December 31, 2023 and 2022; 43,287,325 and 24,545,157 shares issued and outstanding at December 31, 2023 and 2022, respectively 4 3 Additional paid-in capital 116,152 83,941 Accumulated deficit (91,219) (61,212)Total Stockholders' Equity 24,937 22,732 Total Liabilities and Stockholders' Equity$33,709 $33,039 IN8BIO, INC.Statements of Operations(In thousands, except share and per share data) Year EndedDecember 31, 2023 2022 Operating expenses: Research and development$16,827 $14,062 General and administrative 13,510 14,459 Total operating expenses 30,337 28,521 Loss from operations (30,337) (28,521)Other income 330 — Net loss$(30,007) $(28,521)Net loss per share – basic and diluted$(1.00) $(1.36)Weighted-average number of shares used in computing net loss per common share – basic and diluted 29,864,932 20,967,955 Company Contact IN8bio, Inc.Patrick McCall+1 646.600.6GDT (6438)info@IN8bio.com Investors Meru AdvisorsLee M. Sternlstern@meruadvisors.com Media Contact Kimberly HaKKH Advisors917.291.5744kimberly.ha@kkhadvisors.com

NEW YORK, Feb. 14, 2024 (GLOBE NEWSWIRE) -- IN8bio, Inc. (NASDAQ: INAB), a leading clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today announced a publication in Frontiers in Immunology that reviews IN8bio’s novel approach for solid tumors, such as glioblastoma (GBM), an aggressive form of brain cancer. Cellular therapies, particularly chimeric antigen receptor T cell therapies (CAR-T), have shown promise in hematologic malignancies but have faced significant challenges when applied to solid tumors like GBM. These obstacles include rapid tumor growth, antigen heterogeneity, and limited response to current therapies. The publication, titled: “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,” explains the mechanism of action behind IN8bio’s novel therapeutic approach called DeltEx Drug Resistance Immunotherapy (DRI) and the current strategy and future directions for this treatment. The INB-200 and INB-400 studies by IN8bio addresses the challenges towards targeting solid tumors by harnessing the innate immune functions of gamma-delta T cells. GBM cells constitutively express stress-associated NKG2D ligands (NKG2DL), which can be further upregulated through the DNA damage response (DDR) pathway triggered by alkylating agents like temozolomide (TMZ). “We believe our results to date represent a significant advancement in the treatment of GBM. By combining standard chemotherapy with gamma-delta T cells genetically engineered to resist the lymphodepleting effects of chemotherapy, we are creating a synergistic effect that enhances the immune response against GBM while minimizing toxicity to healthy tissues,” said Lawrence Lamb, Ph.D., Chief Scientific Officer and Co-Founder of IN8bio. “This new treatment may improve the survival and quality of life of patients with GBM by preventing tumor recurrence and enhancing the immune response to eliminate residual cancer cells.” The current standard of care for newly diagnosed GBM typically involves primary tumor resection followed by six weeks of chemoradiation therapy, succeeded by six cycles of monthly maintenance therapy with TMZ. This regimen typically yields a median progression-free survival (PFS) of 6 to 7 months and an overall survival (OS) ranging from 14 to 16 months. IN8bio‘s Phase 1 trial (INB-200) assessing the safety and efficacy of intracranial infusions of autologously derived DeltEx DRI gamma-delta T cells in addition to standard-of-care maintenance therapy suggests that the therapy is manageable with a possible improvement in PFS. In the Phase 1 study, cells from the patient are isolated, expanded and modified prior to being delivered intracranially to the tumor cavity every month in combination with maintenance TMZ. The trial assesses three different dosing regimens from a single dose delivered on cycle 1, day 1 in Cohort 1, to three doses delivered on day 1 of cycles 1-3 in Cohort 2, to six doses delivered on day 1 of cycles 1-6 in Cohort 3. All patients receive 1x107 cells per dose. The trial aims to improve PFS by targeting residual cancer cells. Of the eight patients who have completed scheduled dosing, all have exceeded the median PFS expected with standard-of-care therapy alone. IN8bio is also conducting a Phase 2 clinical trial of a genetically modified autologous gamma-delta T cell therapy (INB-400) targeting newly diagnosed GBM. The study will assess the safety, efficacy and tolerability of genetically modified DeltEx DRI cells at leading medical centers across the United States. About INB-200 INB-200 is a genetically modified autologous DRI product candidate for the treatment of solid tumors. This novel platform utilizes genetic engineering to generate chemotherapy-resistant gamma delta T cells which can be administered concurrently with standard-of-care treatment in solid tumors. This is a powerful, synergistic treatment approach enabling gamma-delta T cells to persist in the presence of chemotherapy, and maintain their natural ability to recognize, engage and kill cancer cells. INB-200 is the first genetically engineered gamma-delta T cell therapy to be administered to patients with solid tumors and our initial indication is in GBM. About INB-400 INB-400 is IN8bio’s DeltEx autologous and allogeneic DRI technology. Allogeneic INB-400 will expand the application of DRI gamma-delta T cells into other solid tumor types through the development of allogeneic DeltEx DRI technology. About IN8bio IN8bio is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell product candidates for solid and liquid tumors. 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. IN8bio’s DeltEx platform employs allogenic, autologous, iPSC and genetically modified approaches to develop cell therapies, designed to effectively identify and eradicate tumor cells. IN8bio has initiated a Phase 2 trial of INB-400 in GBM at multiple centers across the United States and has two ongoing Phase 1 trials in solid and hematologic tumors, including INB-200 for GBM and INB-100 for patients with hematologic malignancies undergoing transplantation. IN8bio also has a broad portfolio of preclinical programs focused on addressing other hematological and solid tumor cancers. For more information about IN8bio and its programs, please visit . Forward Looking Statements This 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 the ability of CAR-T cellular therapies to treat hematologic malignancies and GBM; the ability of the INB-200 study (i) to present a significant advancement in the treatment of GBM, (ii) create a synergistic effect that enhances the immune response against GBM while minimizing toxicity to healthy tissues and (iii) improve the survival and quality of life of patients with GBM by preventing tumor recurrence and enhancing the immune response to eliminate residual cancer cells; the ability of IN8bio’s Phase 1 trial in INB-200 to improve PFS by targeting residual cancer cells; and extending IN8bio’s cash runway into 2025; IN8bio’s ability to extend runway upon receipt of additional capital from the December 2023 private placement; IN8bio’s ability to raise additional capital from the December 2023 private placement; IN8bio’s ability to advance its work in other solid tumor indications; the potential for INB-400 to treat GBM; the timing of initiation, progress and scope of clinical trials for IN8bio’s product candidates, including INB-100, INB-200 , INB-300 and INB-400; and IN8bio’s ability to achieve anticipated milestones, including expected data readouts from its trials, enrollment of additional patients in its clinical trials and advancement of clinical development plans. 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 9, 2023, 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. Company Contact IN8bio, Inc. Patrick McCall +1 646.600.6GDT (6438) info@IN8bio.com Investors Argot Partners IN8bio@argotpartners.com Media Contact Kimberly Ha KKH Advisors 917-291-5744 kimberly.ha@kkhadvisors.com

Based on Preliminary Data from Ongoing Dose Ranging Stage of the Phase 1/2 Clinical Trial MILAN, Italy and NEW YORK, Feb. 08, 2024 (GLOBE NEWSWIRE) -- Genenta Science (NASDAQ: GNTA), a clinical-stage immuno-oncology (I/O) company developing a cell-based platform harnessing the power of hematopoietic stem cells to provide durable and safe treatments for solid tumors, today announced that: We have successfully dosed the first of three patients in Cohort 8 (Temferon™ at 4x10^6/kg), the last cohort of the Phase 1 dose-ranging part of the Phase 1/2 clinical trial in newly diagnosed uMGMT Glioblastoma Multiforme (TEM-GBM) patients. The second patient has been enrolled and the treatment is planned. Thus far, the preliminary data indicate no dose-limiting toxicities related to Temferon have been detected in any of 22 treated patients. Temferon-derived differentiated cells were evident within the peripheral blood 14 days after infusion and were still detectable at more than 24 months. As of December 2023, preliminary data in uMGMT patients, the most aggressive form of GBM, show a 2-year Overall Survival (OS) of 25%; the historically reported data observed in uMGMT and methilated patients undergoing current standard of care is approximately 14% to 18%, respectively. We expect reporting top line Phase 1 dose-ranging data by the end of 2Q24. Dr. Luigi Naldini, co-founder of Genenta and Director at the San Raffaele - Telethon Institute for Gene Therapy, stated, “Several techniques, including RNA single-cell analysis, suggest that Temferon can reprogram the Tumor Microenvironment (TME) in patients similarly to what we had demonstrated in preclinical models and activate the immune cell infiltration towards mounting immune responses against the tumor.” “We had a patient who, albeit anecdotal, survived for over three years with Temferon and second line treatment, with a stable tumor during that period,” reported Carlo Russo, CMO and Head of Development. “We believe our preliminary data generated so far, including the duration of the cell presence in the patients, combined with our pre-clinical data showing the agnostic efficacy, open up intriguing possibilities for the use of Temferon in a variety of solid tumors.” “The absence of limiting toxicity observed so far suggests the ability of our technology to prevent systemic toxicity in humans commonly associated with powerful anti-tumor proteins,” noted Pierluigi Paracchi, CEO of Genenta. About Genenta and Temferon Genenta ( ) is a clinical-stage biotechnology company engaged in the development of a proprietary hematopoietic stem cell therapy for the treatment of a variety of solid tumor cancers. Temferon™ is based on ex-vivo gene transfer into autologous Tie2+ hematopoietic stem/progenitor cells (HSPCs) to deliver immunomodulatory molecules directly via tumor-infiltrating monocytes/macrophages (Tie2 Expressing Monocytes - TEMs). Temferon, which is under investigation in a phase 1/2a clinical trial in newly diagnosed Glioblastoma Multiforme patients who have an unmethylated MGMT gene promoter (uMGMT-GBM), is designed to reach solid tumors, induce a durable immune response not restricted to pre-selected tumor antigens nor type, and avoid systemic toxicity, which are some of the main unresolved challenges in immuno-oncology. Forward-Looking Statements Statements in this press release contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” "will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Genenta’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the completion and timing of the phase 1/2a clinical trial or any studies relating to the treatment of glioblastoma multiforme patients who have an unmethylated MGMT gene promoter (uMGMT-GBM). Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in Genenta's Annual Report on Form 20-F for the year ended December 31, 2022 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of the date of this announcement, and Genenta undertakes no duty to update such information except as required under applicable law. Genenta Media Tiziana Pollio, mobile +39 348 23 15 143 tiziana.pollio@genenta.com