Announcement • Mar 28
IN8bio, Inc., Annual General Meeting, May 07, 2026 IN8bio, Inc., Annual General Meeting, May 07, 2026. New Risk • Mar 13
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 15% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 15% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (261% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$21m net loss in 3 years). Share price has been volatile over the past 3 months (15% average weekly change). Market cap is less than US$100m (US$18.7m market cap). Price Target Changed • Feb 22
Price target decreased by 48% to US$6.25 Down from US$12.10, the current price target is an average from 4 analysts. New target price is 303% above last closing price of US$1.55. Stock is down 81% over the past year. The company is forecast to post a net loss per share of US$3.22 next year compared to a net loss per share of US$17.05 last year. Announcement • Feb 10
IN8bio, Inc. Promotes Kate Rochlin to President and Chief Operating Officer, Effective February 9, 2026 IN8bio, Inc. announced the promotion of Kate Rochlin, Ph.D., to President and Chief Operating Officer, effective February 9, 2026. Dr. Rochlin has served as IN8bio’s Chief Operating Officer since December 2021, following her tenure as Vice President and Associate Vice President of Operations and Innovation beginning in August 2020. In her expanded role, she will continue to oversee company operations as IN8bio advances its clinical and preclinical pipeline and prepares for its next phase of growth. Dr. Rochlin brings more than 17 years of experience across biotechnology company development, including scientific research, intellectual property, business development, clinical manufacturing and operations spanning corporate strategy, partnering, and team buildout. Prior to joining IN8bio, she was Chief Business Officer at Curadigm, a biotech developing precision-targeted drug delivery technologies, where she helped lead the company’s spin-out from Nanobiotix.Since joining IN8bio, Dr. Rochlin has played a key role in advancing the company’s programs, including INB-619, a potential first-in-class, pan-?d T cell engager for deep B cell depletion in autoimmune disease. IN8bio recently presented preclinical data showing that INB-619 achieved complete B cell depletion comparable to approved T cell engagers, with minimal adverse cytokine release and robust expansion of ?d T cells. These results validate the differentiation of IN8bio’s T cell engager platform and support continued regulatory engagement and advancement toward the clinic. Dr. Rochlin has also been instrumental in developing and expanding IN8bio’s clinical manufacturing program, leading analytical, quality, regulatory and GMP manufacturing teams across multiple Phase 1 and 2 clinical programs in glioblastoma and hematological cancers. Dr. Rochlin earned a Ph.D. in Molecular Biology and Genetics from Weill Cornell Medical College, conducted research at Sloan Kettering Institute, and earned a BA in Biology from the University of Pennsylvania. New Risk • Jan 27
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 16% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (16% average weekly change). Shareholders have been substantially diluted in the past year (304% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$22m net loss in 3 years). Market cap is less than US$100m (US$21.5m market cap). Announcement • Jan 13
In8bio, Inc. Presents Updated Phase I/II Data Demonstrating Meaningful and Durable Survival Improvements in Newly Diagnosed Glioblastoma IN8bio, Inc. reported updated clinical data from its INB-200 Phase 1 and INB-400 Phase 2 trials in newly diagnosed Glioblastoma (GBM). The prior results were presented at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting. Patients in both the Phase 1 and 2 who received repeated doses of the Company's investigational therapy, DeltEx™? Drug-Resistant Immunotherapy gamma-delta (gd) T cells (DRI) (N=14), experienced substantial improvements in both median progression-free (mPFS) and median overall survival (mOS) across multiple clinical centers. This data is put into greater context compared to contemporaneously enrolled patients treated only with SOC at the same clinical trial sites (N=10), forming a concurrently treated control cohort: Median progression-free survival (mPFS): DeltEx DRI 13.0 months vs. 6.6 months with SOC (a +97% improvement). Median overall survival (mOS): DeltEx DRI, not yet reached, currently 17.2+ months and rising, compared with 13.2 months (final mOS) for SOC. The durability of these mPFS results, combined with a well-tolerated safety profile, underscore the potential of gd T cell therapy to meaningfully improve newly diagnosed GBM treatment and patient outcomes. For the first time, IN8bio presented data from a control group of patients that were contemporaneously enrolled and treated only with the SOC protocols at the same clinical centers with the same treating physicians as the DeltEx DRI cohorts. The SOC control patients performed in-line with expectations based on historical GBM mPFS of 6.9 months, despite a greater number of patients receiving gross total resections. This demonstrates both the aggressive nature of GBM, even with SOC treatment, and the significant need for new treatment options. The funds received from IN8bio's recent financing announced late in 2025 will support further discussions with the FDA on potential clinical pathways, including any potential for accelerated approval. Across both Phase 1, INB-200, and Phase 2, INB-400, trials at multiple centers, DeltEx DRI gd T cells continued to demonstrate a well-tolerated Safety profile, with: No DLTs; No cytokine release syndrome (CRS); No immune effector cell-associated neurotoxicity (ICANS); No unexpected infections or SAEs. New Risk • Dec 20
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (92% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$6.40m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$9.1m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Announcement • Dec 19
IN8bio, Inc. announced that it expects to receive $40.2 million in funding from Coastlands Capital LP, Stonepine Capital Management LLC and other investors IN8bio, Inc. announced that it has entered into a definitive securities purchase agreement with certain institutional and accredited investors for common shares at a price of $1.38 per share, and pre-funded warrants at a price $1.3799 per pre-funded warrant for aggregate gross proceeds of up to approximately $40.2 million on December 19, 2025. The transaction includes an initial closing of approximately $20.1 million by issuing 5,127,029 common shares and 9,452,677 pre-funded warrants. The pre-funded warrants will have an exercise price of $0.0001 per share and will be immediately exercisable. The company will be eligible to receive up to an additional approximately $20.1 million in gross proceeds in exchange for up to 14,579,706 shares of common stock (or, for certain investors, pre-funded warrants in lieu of common stock). The initial closing of the private placement is expected to occur on or about December 22, 2025, subject to satisfaction of customary closing conditions. The transaction included participation from new and existing investors including Coastlands Capital LP, Stonepine Capital Management LLC, 683 Capital Partners, LP along with directors and officers of the Company. Announcement • Oct 31
IN8bio, Inc. Expands INB-100 Phase 1 Clinical Trial with Addition of the Ohio State University as New Site IN8bio, Inc. announced that The Ohio State University has been added as a new clinical site in the ongoing Phase 1 trial of the Company's INB-100, a donor-derived allogeneic gamma-delta T cell therapy for patients with leukemias undergoing haploidentical stem cell transplantation. The addition of this leading academic institution reflects a strong interest in INB-100 and supports the ongoing efforts to accelerate enrollment and complete this Phase 1 trial. The INB-100 trial is being run by Principal Investigator Dr. Joseph P. McGuirk, the Schutte-Speas Professor of Hematology-Oncology, Division Director, Hematologic Malignancies and Cellular Therapeutics, Medical Director, Blood and Marrow Transplant at the Kansas University Cancer Center (KUCC). The trial is designed to evaluate the safety, durability, and anti-leukemic activity of IN8bio's allogeneic gamma-d Delta T cell therapy in the post-transplant setting. The Company has previously presented clinical data demonstrating encouraging long-term survival outcomes relative to real-world historical data, immune reconstitution including expansion and persistence of the allogenic INB-100 gamma-delta T cell therapies up to 1-year post treatment, and absence of severe graft-versus-host disease. Announcement • Oct 28
IN8bio, Inc. Presents T Cell Engager Data Demonstrating Deep B Cell Depletion for Autoimmune Indications IN8bio, Inc. presented new preclinical data from its gd T cell engager program, INB-619, at the 2025 American College of Rheumatology (ACR) Convergence Meeting in Chicago. In preclinical SLE donor models, INB-619 achieved complete elimination of B cells with efficacy equivalent to approved CD19 and CD20 engagers, including the FDA-approved compounds blinatumomab and mosunetuzumab. The data demonstrated minimal secretion of adverse cytokines such as IL-6, a validated biomarker for cytokine release syndrome (CRS), at concentrations multiples lower than the currently marketed compounds tested. INB-619's targeted immune activation and cytokine-sparing design could allow for higher doses, deeper B cell depletion and immune reset that has not been observed with other protein engagers to date. INB-619' unique ability to expand gd T cells in vivo allows it to overcome the low baseline gd T cell counts that have limited other gd-TCE technologies in development. The results highlight INB-619's potential to transform the treatment of autoimmune diseases by harnessing the unique properties of gd T cells to safely and precisely eliminate pathogenic B cells and drive immune reset. The data also demonstrated robust, dose-dependent B cell killing and gd T cell expansion, maintaining a favorable cytokine profile consistent with the unique biology of gd T cells. gd T cells are specialized immune cells capable of potent killing activity with low or no cytokine release. Price Target Changed • Aug 12
Price target decreased by 35% to US$70.13 Down from US$108, the current price target is an average from 4 analysts. New target price is 3,017% above last closing price of US$2.25. Stock is down 88% over the past year. The company is forecast to post a net loss per share of US$5.10 next year compared to a net loss per share of US$17.05 last year. Price Target Changed • Aug 11
Price target increased by 10% to US$119 Up from US$108, the current price target is an average from 5 analysts. New target price is 5,030% above last closing price of US$2.31. Stock is down 88% over the past year. The company is forecast to post a net loss per share of US$6.20 next year compared to a net loss per share of US$17.05 last year. New Risk • Jun 11
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.92m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$19m free cash flow). Shareholders have been substantially diluted in the past year (134% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$9.92m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$24m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Announcement • Jun 10
IN8bio, Inc. Recognizes Achievement of 4- Years in Remission for Patient Treated with INB-200 in Glioblastoma Trial IN8bio, Inc. announced that Patient 009 in the Phase 1 trial of INB-200 for newly-diagnosed GBM has recently reached a significant clinical milestone. The patient, with a grade 4, IDH-mutant glioma, has been in remission and surviving for 4 years having been treated with INB-200. The patient is doing well, has returned to work and has a good quality of life post-treatment with INB-200. Patient 009's clinical progress and 4-year remission far surpasses progression-free outcomes observed in other clinical trials of IDH-mutant glo-mutant glioma patients. INB-200 recently presented updated Phase 1 data from the INB-200 trial at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The results showed that repeated doses of INB-200 demonstrated an extended mPFS of 16.1 months, more than double the expected 6.9 months typically observed with the standard-of-care Stupp protocol in newly diagnosed GBM. INB-200 is the first genetically modified gamma-delta T cell therapy evaluated in GBM and has demonstrated a favorable safety profile and signals of long-term benefit. New Risk • Jun 10
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$19m free cash flow). Shareholders have been substantially diluted in the past year (134% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$24m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Market cap is less than US$100m (US$14.4m market cap). Announcement • Jun 02
In8bio, Inc. Presents Positive Phase 1 Data of Inb-200 in Newly Diagnosed Gbm Demonstrating Prolonged Progression-Free Survival IN8bio, Inc. announced new long-term clinical data from its fully enrolled Phase 1 trial of INB-200 in patients with newly diagnosed glioblastoma multiforme (GBM). The data were presented in an oral session on May 30th at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. By comparison, a 2 to 3 month improvement in mPFS has historically been considered as clinically significant and the bar for approval by the Food and Drug Administration (FDA). Highlights from the Clinical Data as of May 31, 2025: INB-200: Four patients (40%) who received repeated doses of INB-200 remain alive and progression free for a median of over two years, with three returning to work; No additional relapses were observed since the last data update on October 18, 2024; Among patients who received multiple doses of INB-200, mPFS reached 16.1 months, compared to 6.9 months with SOC and 8.3 months for patients who received only a single dose of INB-200; Repeat dosing demonstrated no additional safety risks, with most side effects being mild and attributable to the SOC therapy; 50% of patients receiving repeated doses remained progression-free >18 months versus 0% of patients who received a single dose; INB-400; Data from Phase 2 clinical trial of INB-400 in patients with newly diagnosed GBM, including three additional clinical sites, also show encouraging preliminary results: current mPFS is at 10.8 months. The Company's DRI technology is designed to treat newly diagnosed GBM by harnessing the natural tumor-targeting power of gamma-delta T cells and the sensitizing effects of chemotherapy. INB-400's ability to improve mPFS; the ability of IN8bio's DRI technology to offer a new way to treat newly-diagnosed GBM; gamma-delta T cells' ability to Elimi nate chemotherapy-resistant cancer and stem cells that often survive SOC treatment; 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; 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 be unable to raise additional capital and could be forced to delay, further reduce or to explore other strategic options for certain of its development programs, or even terminate its operations; IN8bio's ability To continue to operate as a going concern; the risk that IN8ssio may not realize the intended benefits of its gd-TCE platform or DeltEx platform; the 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. Announcement • May 15
IN8bio, Inc. Presents Preclinical Data Highlighting Potential of INB-619 T Cell Engager (TCE) for Autoimmune Disease at ASGCT 2025 IN8bio, Inc. announced new preclinical data from its INB-619 program at the 2025 American Society of Gene & Cell Therapy (ASGCT) Annual Meeting. The data shows that INB-619, a CD-19 targeted gd TCE, successfully eliminated disease-causing B cells in blood samples from patients with active Systemic Lupus Erythematosus (SLE, or Lupus). The study reinforces the potential of gd T cell engagers as a safer, more precise immunotherapy platform for autoimmune diseases. With these encouraging results, IN8bio continues to explore potential partnerships and additional autoimmune and cancer indications where gd T cell biology and B cell targeting intersect. New Risk • May 13
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$19m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$19m free cash flow). Shareholders have been substantially diluted in the past year (84% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$24m net loss in 3 years). Market cap is less than US$100m (US$13.2m market cap). Announcement • May 12
IN8bio, Inc. Presents Data at ISCT 2025 Demonstrating Proprietary ?d T Cell Manufacturing Generates Consistent and Robust Clinical Products IN8bio, Inc. announced new data on its proprietary ?d T manufacturing program. The oral presentation shared exciting updates about its unique manufacturing processes, including deep analytics, genomics and repertoire analysis, presented at the International Society for Cell & Gene Therapy (ISCT) 2025 Annual Meeting. The data, which earned IN8bio the prestigious Host Region (U.S. East) Abstract Award, as presented by Bruce Levine, PhD, ISCT Past President and a member of IN8bio's Scientific Advisory Board. The award is a competitive recognition for scientific excellence and demonstrates how IN8bio's technology and know-how creates consistent, powerful cellular therapies. The oral presentation highlights how IN8bio's DeltEx™? Allo manufacturing process consistently induces donor derived T cells to express ?d T cell receptors (TCRs) and genes, associated with increased cancer cytotoxicity. Gene expression profiling confirmed a highly potent product across multiple manufacturing batches. Key Findings from the INB-100 Study Presented at ISCT: Manufacturing-Driven TCR Reprogramming: All analyzed clinical batches showed a clear and consistent shift from ab-TCR to ?d -TCR dominance, with enrichment of Vg9 clones. This shift occurred independent of donor starting material, indicating the process--not the donor--drives final TCR composition. Uniform Potency Markers Across Donors: All manufactured clinical products showed high expression levels of genes linked to increased cancer killing, immune activation, and tumor seeking migration. Durable Remissions in AML Patients: All 10 patients in the initial cohort remained relapse-free for more than one year, with a median overall survival of 23.3 months as of January 2024. These results highlight the strength and reproducibility of IN8bio's cell therapy manufacturing processes. These products were administered clinically in the INB-100 clinical trial, which has demonstrated durable long-term remissions in adult AML patients with high-risk, complex disease characteristics. Further, long term expansion and persistence of the ?d T cells have been observed in these patients through 1 year, a first for an allogeneic cellular therapy product. IN8bio's manufacturing program has been automated, enabling rapid and reproducible production of cryopreserved cell therapy doses. The INB-100 trial continues to enroll an expansion cohort at the recommended Phase 2 dose (RP2D). New Risk • May 09
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 9.5% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 9.5% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (84% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Less than 1 year of cash runway based on current free cash flow (-US$19m). Currently unprofitable and not forecast to become profitable over next 3 years (US$35m net loss in 3 years). Market cap is less than US$100m (US$13.6m market cap). Announcement • Apr 29
IN8bio Unveils Promising New Data from Next Generation Gamma-Delta T Cell Engager (TCE) Platform At AACR 2025 IN8bio, Inc. announced new preclinical data from its innovative gd T cell engager (gd-TCE) platform. The data will be presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting on April 30, 2025. The data showed that IN8bio's new gd-TCE platform demonstrated potent and consistent cancer-killing activity across targets in leukemia models, while avoiding the secretion of cytokines that drive the dangerous side effects seen with other TCE based immune therapies. Unlike traditional TCEs that rely on CD3 to activate all T cells in the body - often triggering excessive inflammatory responses, potential T cell exhaustion and other serious side effects - IN8bio's next-gen platform is designed to specifically activate only gd T cells, a small but powerful subset of immune cells. This potentially offers a lower risk of cytokine release syndrome (CRS) or the neurotoxicity that can impact 60-75% of patients treated with conventional CD3 TCEs. Key highlights from the in vitro studies: INB-619 and INB-633 both triggered strong and specific, linear dose-related killing of leukemia cells (ALL and AML) at low picomolar concentrations. Because this new off-the-shelf platform can drive gd T cell expansion without the need for genetic engineering, it has the potential to offer a more scalable and flexible approach to building next-generation immunotherapies. New Risk • Mar 14
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -US$24m This is considered a minor risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (67% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Less than 1 year of cash runway based on current free cash flow (-US$24m). Currently unprofitable and not forecast to become profitable over next 3 years (US$30m net loss in 3 years). Share price has been volatile over the past 3 months (14% average weekly change). Market cap is less than US$100m (US$16.4m market cap). Announcement • Mar 08
IN8bio, Inc. Announces Resignation of Travis Whitfill from the Board and its Committees, Effective as of May 9, 2025 On March 4, 2025, Travis Whitfill notified the board of directors (the ‘Board’) of IN8bio, Inc. (the ‘Company’) of his resignation from the board and its committees, effective as of May 9, 2025. Mr. Whitfill’s resignation is not due to any disagreement with the Company on any matter relating to the Company’s operations, policies or practices. Announcement • Feb 15
IN8bio, Inc. Presents Positive Phase 1 Data at TCT 2025, Highlighting Durability of Remissions in High-Risk AML IN8bio, Inc. presented Phase 1 data on its allogeneic gamma-delta T cell therapy, INB-100, at the 2025 Transplantation & Cellular Therapy (TCT) Meetings in Hawaii. The data, previously announced, reinforce INB-100's potential to significantly reduce post-transplant relapse in high-risk acute myeloid leukemia (AML) patients, positioning this gamma-delta T cell Therapy as a promising approach in hematologic oncology. INB-100 harnesses the innate tumor-targeting properties of gamma-delta T cells to improve long-term outcomes, potentially filling a critical treatment gap. IN8bio is accelerating patient enrollment in the INB-100 program and expects to complete enrollment of the expansion cohort in 2025. The company's FDA discussions confirmed that relapse-free survival (RFS) is an acceptable primary endpoint for a future potentially pivotal randomized controlled trial in AML patients. IN8bio recently hosted a Key Opinion Leader webinar discussing the latest developments in gamma-delta T cell treatment and the promising INB-100 clinical data. Announcement • Feb 13
IN8bio Reports Updated Positive Results from Phase 1 Trial of INB-100 in Leukemia Patients IN8bio, Inc. announced encouraging new clinical data from the ongoing Phase 1 investigator-sponsored trial of INB-100, an allogeneic gamma-delta T cell therapy designed to help patients with complex leukemias, including AML. INB-100, given following hematopoietic stem cell transplantation (HSCT), is demonstrating the potential to achieve durable long-term remissions and improved survival. The data will be presented at the 2025 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, hosted in Honolulu, HI. Highlights: 100% of AML patients remain relapse-free: All treated AML patients in both the original and expansion cohorts through January 17, 2025 remain in complete remission. The original cohort of AML patients has reached a median CR of 23.3 months, with several patients in remission for over three years. The median duration across all treated AML patients (N=9) is 20.1 months. Trial displays improved survival outcomes vs. standard treatment: When compared with real-world historical data, INB-100 demonstrated significantly higher survival rates: INB-100: All patients - 90.9% PFS and OS of 100% at one-year; and AML patients - 100% PFS and OS of 100% at one-year. Historical controls in AML: Center for International Blood and Marrow Transplant Research (CIBMTR) demonstrate a PFS of 67.8% and OS of 74.7% at one-year; and Kansas University Cancer Center (KUCC) PFS of 57.4% and OS of 66.7% at one-year. Results demonstrate activity even with older, high-risk patients receiving reduced intensity conditioning (RIC) Relapse is the most significant challenge leading to mortality for patients undergoing HSCT. Many of the patients enrolled in the study were older (median age = 68), had complex, high-risk disease or had failed multiple prior therapies, including CAR-T treatments, yet they achieved durable, long-term remission with manageable side effects. Therapy appears to be well-tolerated without significantly impacting patient Quality of Life No cytokine release syndrome (CRS) or neurotoxicity; (ICANs) - Tolerable graft-versus-host disease (GvHD) in-line with historical data that is managed with steroids; and Limited, mild infections. Announcement • Feb 11
IN8bio, Inc., Annual General Meeting, May 08, 2025 IN8bio, Inc., Annual General Meeting, May 08, 2025. Location: 350 5th avenue, suite 5330, new york 10118, new york United States Announcement • Feb 09
Nasdaq Grants IN8bio an Additional 180 Calendar Days, or Until August 4, 2025, to Regain Compliance with the Minimum Closing Bid Price Requirement On February 5, 2025, IN8bio, Inc. (the ‘Company’) received a notice (the ‘Extension Notice’) from the Listing Qualifications Department of the Nasdaq Stock Market (‘Nasdaq’) informing the Company that Nasdaq granted the Company an additional 180 calendar days, or until August 4, 2025, to regain compliance with the minimum closing bid price requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the ‘Rule’). In connection with the Extension Notice, the listing of the Company’s common stock was transferred from the Nasdaq Global Market to the Nasdaq Capital Market, effective as of February 7, 2025. The Extension Notice has no other immediate effect on the listing of the Company’s common stock. If at any time before August 4, 2025, the closing bid price of the Company’s common stock is at least $1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide written confirmation that the Company has achieved compliance with the Rule. If compliance with the Rule cannot be demonstrated to Nasdaq’s satisfaction by August 4, 2025, Nasdaq will provide written notification that the Company’s common stock will be delisted. At that time, the Company may appeal Nasdaq’s delisting determination to a Nasdaq Hearings Panel. The Company intends to continue actively monitor the bid price for its common stock between now and August 4, 2025, and will consider available options to resolve the deficiency and regain compliance with the Rule. These options include, but are not limited to, effecting a reverse stock split, if necessary, to attempt to regain compliance. Price Target Changed • Feb 07
Price target decreased by 36% to US$4.75 Down from US$7.38, the current price target is an average from 4 analysts. New target price is 1,727% above last closing price of US$0.26. Stock is down 79% over the past year. The company is forecast to post a net loss per share of US$0.56 next year compared to a net loss per share of US$1.00 last year. Announcement • Dec 10
IN8bio Reports Continued Progression-Free Survival in Phase 1 Investigator-Sponsored Trial of INB-100 Allogeneic Gamma-Delta T Cells for Leukemias at the 2024 American Society of Hematology Annual Meeting IN8bio, Inc. announced updated data from the ongoing Phase 1 trial of INB-100, an allogeneic, haploidentical gamma-delta T cell therapy in older patients with hematologic malignancies undergoing haploidentical stem cell transplant (HSCT) with reduced intensity conditioning (RIC) at the 2024 American Society of Hematology (ASH) Annual Meeting, being hosted in San Diego, CA. In a poster presentation, IN8bio reported that there have been no newly reported deaths or relapses as of September 30, 2024. As of that cutoff date, median CR was at 16.4 months following a median of 19.2 months of follow-up. As previously reported, all patients (n=10) remained alive, progression-free, and in durable CR through one-year. 100% of AML patients remain in CR after a median 19.7 months of follow-up with three patients with high-risk cytogenetic AML and receiving no maintenance therapy remaining in mCR for greater than three years.INB-100 continues to demonstrate in vivo expansion and persistence of an haplo-matched allogeneic, or donor-derived cellular, therapy at 365 days with blood levels of gamma-delta T cells surpassing levels previously observed to be associated with greater survival. The persistence of these cells is suggestive of continued gamma-delta T cell surveillance against leukemic relapse. In addition to the reported complete responses, INB-100 continued to demonstrate a well-tolerated safety profile with no cytokine release syndrome (CRS) or neurotoxicity (ICANS) observed and limited mild infections. Based upon these encouraging results, the INB-100 trial has been expanded to enroll additional patients at Dose Level (DL) 2, the recommended Phase 2 dose (RP2D). Enrollment of additional patients into the expansion cohort is on-going and updated data, are expected to be reported in the first half of 2025. The Phase 1 investigator-sponsored trial enrolled and treated ten patients at one of two dose levels (D1 or D2). The median age was 68 years with the majority of patients diagnosed with AML in CR1. Two patients (009 and 011) had TP53 mutations, a tumor suppressor that results in poor prognosis, rapid progression and reduced lifespan due to an inability to respond to mutated or damaged DNA. The latest INB-100 trial data on immune reconstitution continues to show significant allogeneic gamma-delta T cell expansion and persistence in patients through the first 365 days post-treatment. As of September 30, 2024, 100% of patients (n=10) surpassed one-year survival following their haplo-matched transplant and treatment with INB-100. Historically, approximately 25% of patients relapse by 100 days and 40-50% of patients relapse by one year.Updated safety data includes:No dose limiting toxicities (DLTs) and no treatment related deaths were observed.Low grade (1-2) acute graft versus host disease (GvHD) observed in 60% of patients treated. Cases were all steroid responsive. Treatment-related serious adverse events included Grade 2 rash (60%) and Grade 3 nausea (20%).One patient death previously reported due to idiopathic pulmonary syndrome likely related to the underlying HSCT at 15.5 months, without disease progression.No ICAN, CRS, or major infections were observed.Seven patients across DL 1 and DL 2 remained on study and in CR, with three having surpassed three years, including one now remaining progression free for over four years. Announcement • Nov 27
IN8bio Reports Continued Durable Remissions in Phase 1 Trial of INB-200 in Plenary Oral Presentation at the Society for Neuro-Oncology (SNO) Annual Meeting IN8bio, Inc. presented results from the fully enrolled Phase 1 trial of INB-200 in a plenary oral presentation at the 29th Annual Meeting of the Society for Neuro-Oncology in Houston, TX. The survival data along with histopathology and radiographic data are indicative of positive treatment effects, which highlight the potential of IN8bio’s genetically modified, chemotherapy-resistant gamma-delta T cells as a potential first-in-class therapy for patients with solid tumor cancers such as glioblastoma (GBM). The Phase 1 trial assessed the safety and preliminary efficacy of the addition of DeltEx DRI gamma-delta T cells to maintenance therapy with TMZ. The trial assessed the administration of 1x107 cells per dose across three different dosing regimens increasing from a single dose in Cohort 1, three doses in Cohort 2, and six doses in Cohort 3. A total of 13 patients have been enrolled and treated with INB-200, including three patients in Cohort 1, four patients in Cohort 2 and six patients in Cohort 3. Key findings from the INB-200 Phase 1 trial: 92% of evaluable patients treated with INB-200 for GBM surpassed a median standard-of-care (Stupp regimen) PFS of 6.9 months, with a majority exceeding their expected PFS based on their age and the MGMT status of their tumors. One patient with an IDH-mutant glioma remains alive and progression free at over 40.5 months; IDH-mutant patients in a recently published clinical trial demonstrated a median PFS of 11.1 months in the control arm and 27.7 months in the experimental arm. No treatment-related serious adverse events, dose-limiting toxicities, cytokine release syndrome, infusion reactions, or immune effector cell-associated neurotoxicity syndrome have been reported in any cohort. The most common treatment emergent adverse events were Grade 1-2 toxicities consisting of white blood cell and platelet count decreases related to standard-of-care TMZ. Gamma-delta T cells and other immune subsets such as CD3+ and CD8+ T cells were found in relapsed tumor biopsies in two patients after treatment with INB-200, pointing to persistence of DRI gamma-delta T cells. Gamma-delta T cells were within the normal range post-resection and remained stable with repeated doses (Cohorts 2 and 3), whereas the gamma-delta T cells in Cohort 1 continued to drop after the maintenance cycles with TMZ were initiated. This implies that repeat dosing of gamma-delta T cells may globally benefit the peripheral immune environment. T cells were low prior to surgery, rose after resection and during the cell collection for the product, were below normal during chemotherapy, and in Cohorts 2 and 3 returned to the normal range following treatment. Radiographic evaluation pre- and post-treatment included resolution of midline shift in one patient with evidence of changes in enhancement attributed to treatment effect in multiple patients. One subject was found to have a 36% decrease in a lesion attributed to positive treatment effect. Announcement • Oct 02
IN8bio, Inc. announced that it expects to receive $12.405547 million in funding IN8bio, Inc. entered into a definitive securities purchase agreement with accredited investors to issue units comprised of an aggregate 25,759,595 shares of common share, par value $0.0001 per share, Pre-funded warrants to purchase 5,646,853 shares of common stock and Series C warrants to purchase up to 31,406,448 shares of common stock for gross proceeds of $12,405,546.96 on October 1, 2024. The units will be sold at a purchase price of $0.395 per unit. The pre-funded warrants will have an exercise price of $0.0001 per share. The Series C Warrants will have an exercise price of $0.27 per share. The private placement was led by an existing healthcare-focused institutional investor and included a large mutual fund company and other existing and new institutional investors. he closing of the private placement is subject to customary closing conditions and is expected to occur on or about October 4, 2024. Announcement • Sep 05
IN8bio, Inc. Announces Clinical Pipeline Prioritization to Focus on INB-100 for Acute Myeloid Leukemia IN8bio, Inc. announced a plan to optimize its resource allocation through a pipeline prioritization and a workforce reduction of approximately 49%. The Company will focus on generating robust clinical data from INB-100, the ongoing investigator-sponsored Phase 1 clinical trial of acute myeloid leukemia (AML), to further de-risk the registrational pathway and affirm the 100% one-year progression-free survival observed to date in this patient population. The Company will suspend its glioblastoma (GBM) development program while continuing to monitor patients in the Phase 1 INB-200 clinical trial and those enrolled in the Phase 2 INB-400 clinical trial. INB-200 has completed patient treatment with up to six repeat doses and further patient enrollment in the INB-400 trial is on hold while the Company explores potential partnership opportunities for the solid tumor program. Portfolio prioritization: INB-100 for AML: With additional funding, the INB-100 trial will continue to enroll patients in the expansion cohort with a new target total enrollment of approximately 25 patients at the recommended Phase 2 dose. IN8bio expects to complete this additional enrollment in the first half of 2025, with long-term follow-up results anticipated in late 2025 and in 2026. IN8bio had a Type B meeting with the FDA earlier this summer where the Company received regulatory guidance on advancing INB-100 for the treatment of AML as a post-transplant maintenance therapy, with relapse-free survival as the primary endpoint. To affirm the improvements in relapse free and overall survival observed to date and to further de-risk a future registrational randomized control trial, IN8bio will also seek to add a control cohort to prospectively assess leukemia patients and enable comparison between patients receiving INB-100 to those who only receive standard haplotransplantation. As of August 30, 2024, 100% of AML patients remain relapse-free after receiving their dose of INB-100 after a median follow-up of 18.7 months. The previously reported patients with other leukemic diagnoses (ALL and MDS/MPN overlap with concurrent TP53 mutations) who relapsed have since died of progression. There have been no new relapses reported since the last update. INB-200 and INB-400: The Company has suspended patient enrollment in the INB-400 Phase 2 clinical trial for newly diagnosed GBM while it explores partnership opportunities for the program. IN8bio will continue to monitor patients previously treated in the fully enrolled INB-200 clinical trial as well as any patients that have been enrolled and are undergoing treatment in the INB-400 Phase 2 clinical trial. Workforce Reduction: In conjunction with its pipeline prioritization, IN8bio is implementing a workforce reduction of approximately 49% of its current workforce, across all functional areas and at both its New York City and Birmingham, Alabama sites, along with cash compensation reductions implemented across the executive management team and the Company’s board of directors. IN8bio expects to incur one-time costs of approximately $0.3 million in connection with the workforce reduction, of which nearly all are cash expenditures related to severance. Such costs are expected to be incurred in the third quarter of 2024. Announcement • Aug 13
IN8bio, Inc. Announces Updated Positive Clinical Data from Both of the Phase 1 Investigator-Sponsored Trials of INB-100 for Hematological Malignancies and INB-200 for GBM IN8bio, Inc. announced updated positive clinical data from both of the Company’s Phase 1 investigator-sponsored trials of INB-100 for hematological malignancies and INB-200 for GBM. The Company has also completed a Type B meeting with the FDA and received guidance on the registrational path to advance INB-100 for the treatment of AML. Every AML patient treated with INB-100 remains in complete remission (CR), and patients across both trials have exceeded expected progression-free survival (PFS) to date. These data continue to demonstrate the broad clinical potential of gamma-delta T cells for difficult-to-treat cancers and provides support for the advancement of these therapies into Phase 2 trials. As of August 1, 2024, no new relapses have been reported since the clinical updates provided at the American Society of Clinical Oncology (ASCO) and the European Hematology Association (EHA) annual meetings. Program Details as of August 1, 2024: INB-100 for AML FDA Guidance on Registrational Program: Following a Type B meeting with the FDA earlier this summer, IN8bio received regulatory guidance on advancing INB-100 for the treatment of AML as a post-transplant maintenance therapy, with relapse-free survival as the primary endpoint. To date, 100% of AML patients treated with INB-100 are in long-term CR, providing a promising path for the registrational trial. IN8bio plans to submit an Investigational New Drug (IND) application to the FDA in First Quarter 2025. Pending clearance, the Company could initiate a registrational trial for AML in 2025. 100% 1-year Relapse-Free Survival: All patients dosed in the Phase 1 investigator-sponsored trial continue to demonstrate relapse-free survival beyond one year. These patients are mostly classified as high-risk, a category where ~25% would typically be expected to relapse within 100 days post-transplant and up to 50% by one year. AML Patient Outcomes: 100% of AML patients remain relapse-free after receiving their dose of INB-100. There have been no new relapses reported since the last update with a data cut-off on May 15, 2024. The previously reported patients with other leukemic diagnoses (ALL and MDS/MPN overlap with concurrent TP53 mutations) who relapsed are still alive. The proposed Phase 2 registrational trial will only include patients with AML, a highly aggressive leukemia with high relapse rates, where Phase 1 results to date have shown the most promising long-term responses. Expansion Cohort: Enrollment in expansion cohort is ongoing, and all treated patients remain in CR, with several having been evaluated for at least 90 days post-transplant and the longest nearing seven months. Full enrollment of the 10-patient expansion cohort is expected by the end of 2024, with long-term follow up results anticipated in 2025. Gamma-Delta T Cell Persistence: A significant increase in dose-dependent long-term expansion and persistence of circulating gamma-delta T cells continues to be observed up to day 365 post-infusion. This marks the first instance of an allogeneic cellular therapy demonstrating both persistence and expansion over this extended time frame. Cell persistence potentially allows for the gamma-delta T cells to conduct longer immune surveillance to prevent relapse. INB-200 for GBM Novel Cellular Therapy Approach: IN8bio’s proprietary drug-resistant immunotherapy (DRI) technology combines standard-of-care chemotherapy with gene-edited, chemotherapy-resistant gamma-delta T cells. Initial data points to a potential dose response across the three cohorts with dose-escalation ranging from a single dose in cohort 1, three doses in cohort 2, and up to six repeat doses in cohort 3. All patients in cohort 1 eventually relapsed. There have been no new relapses with a range of remission from 9.5 to 37.9 months in cohorts 2 and 3 to date. Multiple patients in these higher repeat dose cohorts have now exceeded the overall survival expected with standard-of-care alone relative to historical data. MGMT-unmethylated GBM patients: Several patients in this group, who are typically poor responders and generally unresponsive to chemotherapy, have remained in remission longer than expected. Notably, one patient who received six doses of INB-200 has been in remission for over a year. Updated clinical data from this trial is expected to be presented in fourth quarter 2024. INB-400 in Phase 2 trial: This study is investigating six doses of autologous gamma-delta T cells in front-line GBM treatment in combination with standard-of-care. The trial is actively enrolling and treating patients at multiple leading cancer centers across the United States. Announcement • Jun 15
IN8bio, Inc. Presents Positive Data Demonstrating Durable 1-Year Complete Remission in 100% of Evaluable Patients in Phase 1 Trial of INB-100 IN8bio, Inc. presents updated data from its Phase 1 trial of INB-100 at the European Hematology Association (EHA) 2024 Hybrid Congress. The data from INB-100 demonstrated that 100% of evaluable leukemia patients (n=10) remained alive, progression-free, and in durable CR through one year as of May 31, 2024. Enrollment and treatment of patients into the expansion cohort is ongoing, with updated data expected in late 2024 and 2025. IN8bio expects to discuss plans for a potential registrational trial for this indication with the U.S. Food and Drug Administration (FDA) in a Type B meeting this summer. The Phase 1 clinical trial (NCT03533816) is an investigator-sponsored dose-escalation trial of allogeneic derived, gamma-delta T cells from matched related donors that have been expanded and activated ex vivo and administered systemically to patients with leukemia following HSCT approximately 15 to 30 days post engraftment. The single-institution clinical trial is being conducted at The University of Kansas Cancer Center (KUCC). The primary endpoints of this trial include safety and tolerability, and secondary endpoints include rates of GvHD, relapse rate and overall survival. Announcement • Jun 05
IN8bio, Inc. Presents Progression-Free Survival Update from Phase 1 Study of INB-200 At 2024 American Society of Clinical Oncology Annual Meeting IN8bio, Inc. presented encouraging preliminary clinical data of INB-200 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on June 1, 2024. The preliminary data demonstrated that 92% of evaluable patients treated with INB-200 exceeded a median PFS of 7 months (median follow-up: 11.7 months) with concomitant temozolomide (TMZ), as of a data cutoff date of May 30, 2024. The survival data along with radiographic improvements are indicative of positive treatment effects, which highlight the potential of IN8bio’s genetically modified, chemotherapy-resistant gamma-delta T cells as a potential first-in-class therapy for patients with newly diagnosed glioblastoma (GBM). The Phase 1 study assessed the safety and preliminary efficacy of the addition of DeltEx DRI gamma-delta T cells to maintenance therapy with TMZ. The trial assessed the administration of 1x107 cells per dose across three different dosing regimens increasing from a single dose delivered on cycle 1 day 1 during maintenance 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. Thirteen patients have been enrolled and treated with INB-200, including three patients in Cohort 1 (1 dose), four patients in Cohort 2 (3 doses) and six patients in Cohort 3 (6 doses). The current standard of care for newly diagnosed glioma patients consists of primary resection, six weeks of daily chemoradiation therapy followed by six cycles of monthly maintenance TMZ therapy (Stupp regimen), which achieves a median PFS of 7 months and an overall survival (OS) of approximately 14 to 16 months. All of the patients in the Phase 1 study that received all of their protocol defined treatments with INB-200 exceeded a median PFS of 7 months, including one patient in Cohort 2 that remains alive and progression free for nearly three years. The poster presentation at ASCO included promising activity and safety data for the fully enrolled trial, as of the data cutoff date of May 1, 2024. Key findings from the ongoing Phase 1 study: All patients who completed all protocol mandated doses surpassed a median standard-of-care PFS of 7 months, with a majority also exceeding the expected PFS based on their age and MGMT status of their tumors. 92% of evaluable patients treated with INB-200 for GBM exceeded a median PFS of 7 months achieved with the standard-of-care regimen (Stupp regimen). One patient with an IDH-mutant glioma remains alive and progression free at 34.9+ months; IDH-mutant patients in a recently published clinical trial of an IDH inhibitor demonstrated a median PFS of 11.1 months in the control arm and 28.5 months in the experimental arm. No treatment-related serious adverse events, dose-limiting toxicities, cytokine release syndrome, infusion reactions, or immune effector cell-associated neurotoxicity syndrome have been reported in any cohort. The most common treatment emergent adverse events were Grade 1-2 toxicities consisting of white blood cell and platelet count decreases related to standard-of-care TMZ. Preserved gamma-delta T cells were found in relapsed tumor 148 days after initial DRI infusion in one patient with paired biopsies, pointing to durability of DRI gamma-delta T cells. Radiographic evaluation pre- and post-treatment included resolution of midline shift in one patient with evidence of changes in enhancement attributed to treatment effect in multiple patients. One subject was found to have a 36% decrease in a lesion attributed to positive treatment effect. Announcement • May 15
In8bio Demonstrates Robust and Reproducible Gamma-Delta T Cell Therapy Manufacturing in Oral Presentation At Asgct 2024 IN8bio 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 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. Announcement • Apr 30
In8bio, Inc. Doses First Patient in Phase 2 Clinical Trial of Inb-400 in Newly Diagnosed Glioblastoma IN8bio, Inc. announced that the first patient in its Phase 2 clinical trial evaluating INB-400 in patients with newly diagnosed glioblastoma multiforme (GBM) has been successfully dosed at the Cleveland Clinic in Ohio. INB-400 is the Company’s first autologous gamma-delta T cell therapy product candidate genetically engineered to survive chemotherapy and maintain the natural ability to recognize, engage and kill cancer cells when dosed along with current, standard-of-care treatments such as temozolomide (Temodar, or TMZ). Arm A of the INB-400 trial is expected to enroll up to 40 patients. INB-400 was granted Orphan Drug Designation by the FDA in 2023. Gamma-delta T cells are naturally occurring immune cells with unique properties enabling them to naturally differentiate between healthy and cancerous tissues. They serve to bridge between the innate and adaptive immune system, contributing to direct tumor cell killing as well as immune memory, cell recruitment and activation to drive deeper immune responses . The Phase 2 study will evaluate the safety and tolerability of INB-400 in patients with newly diagnosed GBM in combination with TMZ. In Arm A of the trial, investigators will administer T cells to patients on the first day of each of six 28-day maintenance cycles concurrent with TMZ for up to six doses. The primary endpoint of the study is overall survival rate at 12 months. Secondary endpoints include safety and tolerability, overall response rate, time to progression, and progression-free survival. Since 2005, the standard-of-care treatment for GBM has been surgical resection followed by radiation and chemotherapy and six cycles of maintenance temozolomide therapy, referred to as the Stupp regimen. Most patients relapse in six to seven months, with very few patients surviving beyond five years. INB-400 is engineered to be resistant to alkylating chemotherapy, enabling it to be used in combination with the current standard-of-care TMZ to amplify immune signals, maximize tumor killing, and eliminate cancer cells. INB-400 is IN8bio’s DeltEx chemotherapy resistant autologous drug-resistant immunotherapy (DRI). INB-400 was granted Orphan Drug Designation for the treatment of glioblastoma multiforme (GBM) by the FDA in April 2023, marking the first genetically modified gamma-delta T cell therapy to receive this regulatory designation. GBM remains a significant unmet need, treatment options and associated outcomes for GBM, highly aggressive and difficult-to-treat brain cancer, have remained largely unchanged for more than 18 years, with a median progression free survival of 6-7 months and overall survival of 14-16 months. Allogeneic INB-400 will expand the application of DRI gamma-delta T cells into other solid tumor types through the development of allogeneic or “off-the-shelf” DeltEx DRI. Announcement • Apr 28
IN8bio, Inc., Annual General Meeting, Jun 12, 2024 IN8bio, Inc., Annual General Meeting, Jun 12, 2024, at 09:00 US Eastern Standard Time. Agenda: To elect the two Class III directors named in the attached proxy statement, each to serve until company's 2027 Annual Meeting of Stockholders; to ratify the selection of CohnReznick LLP as company's independent registered public accounting firm for the fiscal year ending December 31, 2024; and to conduct any other business properly brought before the meeting or any adjournment or postponement thereof. Announcement • Apr 10
IN8bio, Inc. Announces New Preclinical Data for Gamma-Delta nsCAR-T Cell Therapy Platform at AACR 2024 IN8bio, Inc. announced new preclinical data from its non-signaling gamma-delta T cell based Chimeric Antigen Receptor-T cell (nsCAR) platform, known as INB-300, that demonstrated improved selectivity to target leukemia cells while preserving healthy ones. The data support the potential for nsCAR to have a wider therapeutic window and to be used to prevent on-target off-tumor killing of healthy tissue that may express the CAR-T target. The data was presented in a poster session at the American Association for Cancer Research (AACR) Annual Meeting 2024 on April 9, 2024. IN8bio's nsCAR platform is based on the natural ability of gamma-delta T cells to distinguish between healthy and malignant tissue. By using a Chimeric Antigen Receptor that lacks a signaling domain, IN8bio believes it has created a technology that enables these cells to differentiate between tumor and healthy tissue, even when both express the CAR-targeted antigen. Approved CAR-T therapies have shown remarkable efficacy against B cell malignancies, offering hope to patients with limited treatment options. However, extending this therapy to myeloid malignancies and solid tumors has proven challenging since the antigens they target are also often found on the surface of healthy blood cells and tissues. This unintended targeting of healthy cells and tissues has led to many of the toxicities, including patient deaths, observed in prior CAR-T therapies and has limited their utility. Unlike traditional CAR-T therapy, IN8Bio’s nsCAR is designed to direct the gamma delta T cell to its target while maintaining their unique gamma-delta T cell receptors, allowing them to identify and specifically eliminate heterogeneous tumor cells through recognition of tumor-associated stress antigens. The new data presented at AACR included results from proprietary constructs targeting CD33 and/or CD123 for in vitro evaluation against various types of leukemia, including acute myeloid leukemia and chronic myeloid leukemia. The study results demonstrated notable differences between cells expressing traditional signaling CARs and those expressing the nsCAR constructs, which include a reduction in activation-induced cell death with nsCAR constructs. The nsIL3-33mb15 CAR (CD123+CD33+IL-15) enhancement of the gamma delta T cells against leukemia cells demonstrated an average 1.8x increase in tumor killing capability across three AML cell lines (HL-60, KG-1a and MOLM-13), compared to unmodified gamma-delta T cells as measured by a 24-hour cytotoxicity assay. Importantly, the nsCAR cells did not lead to significant killing of healthy cells expressing the CD33 or CD123 target, demonstrating the selectivity of the nsCAR platform. Results were run in triplicate and on average the selectivity was increased by 5.5x. Across all runs, killing by the nsIL3-33mb15 construct against healthy CD34+ HPCs was below that of un-transduced control gamma-delta T cells. New Risk • Mar 16
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$24m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$24m free cash flow). Earnings have declined by 40% per year over the past 5 years. Shareholders have been substantially diluted in the past year (77% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (15% average weekly change). Market cap is less than US$100m (US$50.2m market cap). Announcement • Mar 06
IN8bio, Inc. to Present New Preclinical Data on Novel Gamma-Delta CAR Platform Candidate at AACR Annual Meeting 2024 IN8bio, Inc. announced the presentation of new preclinical data for its non-signaling gamma-delta T cell based Chimeric Antigen Receptor T cell (CAR-T) platform, INB-300. The data will be presented at the 2024 American Association for Cancer Research (AACR) Annual Meeting, being held April 5-10, 2024 in San Diego, California. The current generation of CAR-T technology eliminates the target antigen regardless of whether it is expressed on tumor or healthy tissue. IN8bio's nsCAR platform, INB-300, uses the CAR to traffic and bind to cells expressing the target and leverages the natural innate immune recognition abilities of gamma-delta T cells to distinguish between tumor and healthy tissue. This allows the cells to selectively eliminate cancer cells while leaving healthy cells intact, even when both express the CAR-target. INB-300 is a non-signaling CAR (nsCAR) gamma-delta T cell platform with several preclinical product candidates, including the INB-330 program against AML targets, that combine expertise in gamma-delta T cells and genetic engineering. These nsCAR constructs lack signaling domains in order to take advantage of the unique properties of gamma-delta T cells to differentiate between healthy and tumor tissues. IN8bio is advancing new nsCAR constructs against multiple targets to treat both solid and liquid tumors. Announcement • Feb 15
IN8bio Announces Publication on Novel Gamma-Delta T Cell Therapy for Glioblastoma in Frontiers in Immunology IN8bio, Inc. 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 ?d 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).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. Announcement • Dec 29
IN8bio, Inc. announced that it has received $14.442298 million in funding from Bios Equity Partners LP On December 28, 2023, IN8bio, Inc. closed the transaction. The transaction included participation from 20 investors. New Risk • Dec 18
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 76% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (25% average weekly change). Earnings have declined by 42% per year over the past 5 years. Shareholders have been substantially diluted in the past year (76% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (US$82.6m market cap). Price Target Changed • Dec 13
Price target decreased by 16% to US$11.00 Down from US$13.13, the current price target is an average from 2 analysts. New target price is 669% above last closing price of US$1.43. Stock is down 29% over the past year. The company posted a net loss per share of US$1.36 last year. Announcement • Dec 07
IN8bio, Inc. Appoints Corinne Epperly to the Board of Directors IN8bio, Inc. announced the appointment of Corinne Epperly, MD, MPH, to its Board of Directors. Dr. Epperly will serve on IN8bio’s Compensation Committee as well as its Science & Technology Committee. She will work closely with the management team to provide guidance on strategic, operational, scientific, and clinical matters related to the Company’s pipeline of gamma-delta T cell therapies. With over two decades of experience in oncology as a physician and a scientist, Dr. Epperly uniquely combines her medical expertise with business and financial acumen. She has spent 15 years in leadership roles with a successful track record in oncology drug development and launches. Before joining IN8bio, Dr. Epperly most recently served as the Chief Operating Officer of CARGO Therapeutics, where she was a key player in CARGO’s formation and the advancement of its next-generation CAR-T cell therapies for cancer patients. Her prior roles include Senior Vice President, Strategy and Operations of Iovance Biotherapeutics and leadership roles at Bristol Myers Squibb, where she played a pivotal role in the launch of OPDIVO® across multiple indications. Announcement • Nov 21
IN8bio, Inc.’s INB-200 Demonstrates Extended Progression-Free Survival in Patients with Newly Diagnosed Glioblastoma IN8bio, Inc. presented data demonstrating that all patients treated with INB-200 who completed mandated doses have exceeded a progression-free survival (PFS) of seven months to date. This survival data shows the potential of IN8bio’s DeltEx Drug Resistant Immunotherapy (DRI) - genetically modified and chemotherapy-resistant gamma-delta T cells to treat patients with newly diagnosed glioblastoma (GBM). The poster highlighting the updated clinical data from the Phase 1 INB-200 trial was presented at the Society for Neuro-Oncology (SNO) 28th Annual Meeting in Vancouver, British Columbia on November 17, 2023. The current standard-of-care regimen for newly diagnosed GBM consists of primary resection, six weeks of chemoradiation therapy followed by six cycles of maintenance monthly temozolomide therapy, which achieves a median PFS of 7 months and an overall survival (OS) of approximately 14 to 16 months. The Phase 1 trial assesses the safety and preliminary efficacy of the addition of DeltEx DRI gamma-delta T cells to standard-of-care maintenance therapy. 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 finally six doses delivered on day 1 of cycles 1-6 in Cohort 3. All patients receive 1x107 cells per dose, however the number of doses varies depending on the cohort of enrollment. The poster presentation at SNO included efficacy and safety data as of the data cutoff on October 20, 2023. Ten patients have been treated with INB-200: three in Cohort 1 (1 dose), four in Cohort 2 (3 doses) and three in Cohort 3 (6 doses). Key findings from the ongoing study include: All patients who completed mandated doses surpassed a PFS of seven months, with most also exceeding the expected PFS based on their age and tumor status. One patient (009) with an IDH-mutant glioma remains alive and progression free at 28.5+ months; comparative data published in the New England Journal of Medicine (NEJM) in August 2023 demonstrate that IDH-mutant patients in the control arm of a clinical trial demonstrated a median PFS of 11.1 months. No treatment-related serious adverse events (SAEs), dose-limiting toxicities (DLTs), cytokine release syndrome (CRS), infusion reactions, or immune effector cell-associated neurotoxicity syndrome (ICANS) have been reported in any cohort. The most common treatment-emergent adverse events (TEAEs) were mostly Grade 1-2 toxicities consisting of white blood cell and platelet count decreases related to standard-of-care temozolomide. Preserved gamma-delta T cells found in relapsed tumor 148 days after initial DRI infusion, pointing to durability of gamma-delta T cells in treating cancer. 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 initial indication is in GBM. Announcement • Nov 07
IN8bio, Inc. Presents Biologic Correlative Data from the Inb-200 Phase 1 Trial in Newly Diagnosed Glioblastoma At the Society for Immunotherapy of Cancer's 38Th Annual Meeting IN8bio, Inc. presented new biological correlative data from the ongoing Phase 1 clinical trial of INB-200 targeting newly diagnosed glioblastoma multiforme (GBM) in a poster presentation at the Society for Immunotherapy of Cancer's (SITC) 38(th) Annual Meeting. Chemotherapy has remained a mainstay of solid tumor treatment. These data demonstrate that the lymphodepleting effects of chemotherapy results in a globally suppressed immune system where the DeltEx DRI gamma-delta T cells can strengthen the immune response and potentially broadly eliminate cancer cells. Furthermore, conventional standard-of-care can act as a long-term lymphodepleting agent, an important component for the development of allogeneic and potentially 'off-the-shelf' cellular therapies. In June 2023, IN8bio presented positive data from the Phase 1 study of INB-200 in an oral presentation at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting. The Company will present updated patient, survival and enrollment data from the study at the Society for Neuro-Oncology (SNO) Annual Meeting taking place November 15-19, 2023. Announcement • Oct 13
IN8bio Completes Dose Escalation in Phase 1 Trial of INB-100, a Potential First-in-Class Gamma-Delta T Cell Therapy for the Treatment of Leukemias, and Initiates Enrollment for the Phase 2 Trial of INB-400 in Newly Diagnosed Glioblastoma IN8bio, Inc. announced the completion of enrollment in the Phase 1 study of INB-100 in leukemia patients and the initiation of patient enrollment in the Phase 2 clinical trial evaluating INB-400 in newly diagnosed glioblastoma multiforme (GBM). Enrollment in the dose escalation phase of the Phase 1 clinical trial (NCT03533816) of INB-100 is now closed. This clinical trial assesses the safety of allogeneic gamma-delta T cells from haploidentical related donors that have been expanded and activated ex vivo and administered systemically to patients with leukemia following hematopoietic stem cell transplantation (HSCT). The primary endpoints of this trial are safety and tolerability, and secondary endpoints include rates of graft versus host disease (GvHD), relapse rate and OS. In April 2023, the Company presented data at the 49th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) showing that 100% of evaluable patients (n=7) treated with INB-100 remained alive, progression-free, and in durable complete remission (CR). As of April 21, 2023, all evaluable patients across Dose Levels 1 and 2 remained on study and in CR, with one patient remaining progression free for over 3 years. Additional treated patients have remained progression free for 33.9, 22.2, 7.8, 5.8, 5.6 and 2.6 months, respectively. A clinical update with additional enrolled patients will be presented at the 65th ASH Annual Meeting being held December 9-12, 2023 in San Diego, CA. The Phase 2 clinical trial of INB-400 (NCT05664243), an autologous, genetically engineered gamma-delta T cell therapy, is open for enrollment and plans to enroll approximately 40 patients in “Arm A” of the study. The primary endpoint of the study is 12-month overall survival (OS) rate, and key secondary endpoints include tolerability, progression-free survival (PFS), overall response rate (ORR) and time to progression (TTP). The University of Louisville and The Cleveland Clinic are the first clinical sites activated to enroll patients. INB-400 was granted Orphan Drug Designation by the FDA in April 2023, marking the first genetically modified gamma-delta T cell therapy to receive this regulatory designation. GBM remains a significant unmet need, treatment options and associated outcomes for GBM, a highly aggressive and difficult-to-treat brain cancer, have remained largely unchanged for more than 18 years, with a median progression-free survival of 6-7 months and overall survival of 14-16 months. INB-400 is IN8bio’s DeltEx chemotherapy resistant autologous and allogeneic drug-resistant immunotherapy (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 or “off-the-shelf” DeltEx DRI technology. INB-100, IN8bio’s DeltEx Allo, is an allogeneic product candidate, initially developed for the treatment of patients with hematologic malignancies undergoing hematopoietic bone marrow transplantation (HSCT). It is currently being evaluated in a Phase 1 dose escalation clinical trial, marking the first clinical trial of an expanded and activated allogeneic gamma-delta T cell immunotherapy. Announcement • Oct 01
IN8bio, Inc. Announces Presentations at the Society for Immunology of Cancer 38th Annual Meeting IN8bio, Inc. announced two poster presentations reporting positive data at the Society for Immunotherapy of Cancer's (SITC) 38th Annual Meeting, taking place November 1-5, 2023, in San Diego, CA. The presentations will showcase biological correlative data from the ongoing Phase 1 clinical trial of INB-200, targeting newly diagnosed glioblastoma multiforme (GBM) and pre-clinical insights on IN8bio's induced pluripotent stem cell (iPSC) gamma-delta T cell platform. Details of the presentations at SITC 2023 are as follows: INB-200: Phase I study of gene modified autologous gamma-delta (gd) T cells in newly diagnosed glioblastomas (GBM) patients receiving maintenance temozolomide (TMZ): immunobiologic correlative data. INB-200 is a genetically modified autologous drug resistant immunotherapy (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 initial indication is in GBM. Announcement • Jun 06
IN8bio, Inc. Announces Updated Data from the Ongoing Phase 1 Clinical Trial of Inb-200 in Patients with Newly Diagnosed Glioblastoma Multiforme IN8bio, Inc. announced updated data from the ongoing Phase 1 clinical trial of INB-200 in patients with newly diagnosed glioblastoma multiforme (GBM). The data were featured as one-of-four oral presentations and the only Phase 1 study during the immunotherapy section of the Central Nervous System Tumors session at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting in Chicago, Illinois. The oral presentation at ASCO includes efficacy and safety data as of a data cutoff of April 30, 2023. Eight patients have been treated with INB-200: three in Cohort 1 (single dose), four in Cohort 2 (three doses) and one in Cohort 3 (six doses). As of May 19, 2023 key findings from the ongoing study include: Cohort 1 patients remained progression-free at 8.3, 11.9, and 7.4 months, with respective overall survival (OS) of 15.6, 17.7, and 9.6 months. Two patients in Cohort 2 remain alive and progression-free at 23.5 and 19.4 months, respectively, exceeding median OS of GBM patients without progression. In Cohort 3, the first patient dosed received five of six planned doses of gamma-delta T cells and had a progression-free survival (PFS) of 7.1 months and OS of 11.8 months with no evidence of additional toxicities. This patient who had an LZRT1 mutation experienced a rare leptomeningeal relapse, along with widespread relapse in their liver, lungs and pelvis. However, there was no progression in their brain, where INB-200 was administered. No treatment-related deaths have been reported in any cohort. Six deaths were observed, three due to progression of disease and three unrelated to either treatment or progression (the deaths were due to sepsis, a cardiac event and pulmonary embolism). No treatment-related serious adverse events (SAEs), dose-limiting toxicities (DLTs) cytokine release syndrome (CRS), infusion reactions, or immune effector cell-associated neurotoxicity syndrome (ICANS) have been reported in any cohort. The most common treatment emergent adverse events (TEAEs) were white blood cell and platelet count decreases related to standard-of-care temozolomide, asthenia, headache and hydrocephalus, mostly Grade 1-2. Three additional patients have been consented in Cohort 3 to date and are advancing through treatment. INB-200 is a genetically modified autologous drug resistant immunotherapy (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 is intended to enable 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 initial indication is in GBM. Announcement • May 18
IN8bio, Inc. Announces Positive Preclinical Data Underscoring the Potential of Its DeltEx Gamma-Delta T Cells to Target and Kill Ovarian Cancer IN8bio, Inc. announced positive preclinical data underscoring the potential of its DeltEx Gamma-Delta T cells to target and kill ovarian cancer. The data were featured in a poster presentation at the American Society of Cell & Gene Therapy (ASGCT) 26th Annual Meeting and showed that DeltEx Gamma-Delta T cells were able to target and kill ovarian cancer cells, even in platinum-resistant and treatment-resistant cell lines. IN8bio’s DeltEx Drug Resistance Immunotherapy, or DeltEx DRI, gamma-delta T cells are engineered to be more effective at killing cancer cells. These cells are designed to be resistant to the killing effects of chemotherapy, allowing them to remain functional and be used concurrently in combinations to create a strong synergistic tumor killing effect. The preclinical data demonstrates that temozolomide (TMZ), an alkylating agent that creates DNA double-stranded breaks, can work synergistically in combination with poly ADP-ribose polymerase inhibitors (PARPi) to significantly increase NKG2D ligand (NKG2D-L) expression. NKG2D-L are proteins that make cancer cells more visible to the immune system, particularly to gamma-delta T cells, and resulted in greater killing of ovarian cancer cells, even in platinum-resistant and treatment-resistant ovarian cell lines. Announcement • Jan 06
IN8bio Provides INB-200 Clinical Update and Outlines 2023 Pipeline Goals IN8bio, Inc. announced a clinical update from the ongoing Phase 1 trial evaluating INB-200 in patients with newly diagnosed GBM and provided pipeline goals for 2023. As of December 31, 2022, eight patients have been dosed with INB-200: three in Cohort 1 (single dose), four in Cohort 2 (three doses) and one in Cohort 3 (six doses). Enrollment is ongoing, with clinical updates expected throughout 2023. Key findings from the ongoing study include: All patients in Cohort 2 remained progression free at 18.9, 14.8, and 8.7 months, respectively. The third patient died at 8.7 months due to a pulmonary embolism unrelated to treatment with no evidence of relapse prior to death.Two patients continue to exceed the median survival for GBM patients with the standard Stupp regimen, suggesting that increasing doses of gamma-delta T cells may favor longer PFS and overall survival (OS). The first patient dosed in Cohort 3 has received five doses of gamma-delta T cells with no evidence of additional toxicities. The patient has no local GBM relapse, which is typical in 95% of GBM cases, but does have evidence of distal leptomeningeal disease.There have been no treatment-related serious adverse events (SAEs) or dose-limiting toxicities (DLTs) observed to date. There have been no instances of cytokine release syndrome (CRS), infusion reactions, or immune effector cell-associated neurotoxicity syndrome (ICANS).Adverse events have been generally tolerable and include grade 1/2 anemia, fevers, headaches, myelosuppression, and nausea. Importantly, to date, repeat dosing does not demonstrate a change in the toxicity profile. Anticipated 2023 Pipeline Goals: INB-100: Report Phase 1 ongoing trial data from leukemia patients undergoing haploidentical stem cell transplantation (HSCT); define maximum tolerated dose for INB-100. INB-200 in GBM: Complete enrollment of Cohort 3 in the Phase 1 trial; report additional data and topline results with longer-term follow-up. INB-300: Present preclinical data demonstrating proof-of-concept of non-signaling CAR (ns-CAR) platform in 1H 2023. INB-400: Initiate patient enrollment in the company-sponsored Phase 2 trial of INB-400, a genetically modified autologous gamma-delta T cell therapy, targeting newly diagnosed GBM by Third Quarter 2023. INB-410: Submit IND to the FDA for a Phase 1b trial of INB-410, a genetically modified allogeneic gamma-delta T cell therapy in newly diagnosed and relapsed GBM. New solid tumor indications: Announce and present relevant data at a scientific conference in 1H 2023. Price Target Changed • Nov 16
Price target decreased to US$9.67 Down from US$11.67, the current price target is an average from 3 analysts. New target price is 512% above last closing price of US$1.58. Stock is down 80% over the past year. The company posted a net loss per share of US$1.47 last year. Board Change • Nov 16
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 7 experienced directors. No highly experienced directors. Co-Founder, President, CEO & Director Will Ho is the most experienced director on the board, commencing their role in 2015. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Board Change • Nov 01
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 7 experienced directors. No highly experienced directors. Co-Founder, President, CEO & Director Will Ho is the most experienced director on the board, commencing their role in 2015. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Board Change • Oct 02
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 7 experienced directors. No highly experienced directors. Co-Founder, President, CEO & Director Will Ho is the most experienced director on the board, commencing their role in 2015. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Recent Insider Transactions • Aug 19
Independent Director recently bought US$200k worth of stock On the 16th of August, Peter Brandt bought around 105k shares on-market at roughly US$1.90 per share. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$277k more in shares than they have sold in the last 12 months. Announcement • Jan 07
IN8bio, Inc. Announces Clinical Updates from the Phase 1 Clinical Trial of its Genetically Modified Gamma-Delta T Cell Therapy in Newly Diagnosed Glioblastoma Multiforme IN8bio, Inc. provided an update from the ongoing Phase 1 clinical trial of INB-200, an autologous DeltEx drug resistant immunotherapy (DRI). DeltEx DRI consists of gamma-delta T cells that have been genetically engineered to be chemotherapy resistant, allowing them to be administered concurrently with alkylating chemotherapeutic agents, including temozolomide (TMZ). This clinical trial, conducted in patients newly diagnosed with glioblastoma multiforme (GBM), is the first and most clinically advanced trial to use genetically modified gamma-delta T cells and includes a multi-dose escalation regimen. Cohort 1 accrual and treatment is complete with three patients having received a single dose of DeltEx DRI via intracranial infusion concurrent with maintenance TMZ administration. Cohort 2 is currently recruiting and treating patients, with one patient having completed all three doses administered intracranially at 28-day intervals concurrent with maintenance TMZ. The Phase 1 clinical trial of INB-200 (NCT04165941) and the progress reported here constitute the first single- and multiple-dosed patients with genetically modified gamma-delta T cells in any indication. INB-200 has had a manageable safety profile in all four patients treated to date, with no DLTs, CRS, immune effector cell-associated neurotoxicity syndrome (ICANS) or treatment-related serious adverse events (SAEs). The data to-date indicate promising PFS and OS, which will continue to be assessed on an on-going basis, with additional data anticipated at medical meetings later this year along with comprehensive biological correlative data. Four patients have been treated to-date. In cohort 1, all have exceeded their expected PFS interval, with an encouraging trend in OS based on standard-of-care for their respective age and methylguanine-DNA methyltransferase (MGMT) status1-3. One of these patients remains alive at 17 months post-treatment, having exceeded their expected PFS and OS. As previously reported, a second patient survived for 15.6 months, with a PFS of 8.3 months, and died from an unrelated medical event without further progression. The third patient in cohort 1 exceeded predicted PFS and died at 9.6 months due to progression. In cohort 2, the first patient to complete all three doses has stable disease at 6.9 months and remains in follow-up. An earlier patient enrolled in cohort 2 completed two doses of INB-200 but died due to an acute cardio-pulmonary event without further disease progression. This was reviewed by the data safety monitoring board (DSMB) and the FDA who deemed the event unlikely to be related to therapy, and the study was allowed to continue uninterrupted. Neither patient dosed in cohort 2 experienced any infusion reactions, CRS, DLTs, or ICANS. Patient recruitment and treatment are ongoing with anticipated completion of enrollment in 2022. INB-200 is an investigator initiated, open-label Phase 1 clinical trial evaluating IN8bio’s DeltEx DRI therapy in newly diagnosed GBM patients. Patients in cohort 1 received a single dose of INB-200, while patients in cohort 2 receive three doses at 28-day intervals and patients in cohort 3 are planned to receive six doses at 28-day intervals. All doses are given concurrently with maintenance TMZ and are intended to eliminate residual cancer during the vulnerable period of chemotherapy-induced tumor injury, when immune stress ligand expression is upregulated. The primary endpoints of this Phase 1 trial are safety and tolerability, with secondary endpoints based on biologic response, progression free and overall survival. Announcement • Dec 17
In8bio Provides Update from the Ongoing Phase 1 Clinical Trial of Its Allogeneic Gamma-Delta T Cell Therapy in Leukemia Patients Undergoing Hematopoietic Stem Cell Transplant IN8bio, Inc. provided an update from the ongoing Phase 1 clinical trial of INB-100, a donor-derived gamma-delta T cell therapeutic in development for patients with leukemia undergoing haploidentical hematopoietic stem cell transplant (HSCT). The three patients with relapsed acute myeloid leukemia (AML) treated to date demonstrate that allogeneic gamma-delta T cell therapy has a manageable toxicity profile with the potential for durable responses in high-risk patients. Haploidentical HSCT patients have high relapse rates of up to 50% at one-year post-treatment. All three of the INB-100 treated patients remain in remission with two patients in remission at 18 and 20 months, respectively. No treatment-related grade 3 or greater adverse events, infusion reactions or dose-limiting toxicities were observed. The trial continues to track these patients and enroll additional patients. This Phase 1 clinical trial (NCT03533816) is a dose-escalation trial of allogeneic, or donor-derived, gamma-delta T cells that have been expanded and activated ex vivo and administered systemically to patients with leukemia following haploidentical HSCT. Three high-risk AML patients with complex cytogenetics have been treated to-date, including patients with trisomy 8, del7 mutations. The single-institution clinical trial is currently being conducted at The University of Kansas Cancer Center (KUCC). The primary endpoints of this trial are safety and tolerability, and secondary endpoints include rates of GvHD, relapse rate and overall survival. Announcement • Aug 12
IN8bio, Inc. Completes Dosing of First Cohort in Phase 1 Clinical Trial with Allogeneic Gamma Delta T-Cell Therapy in Leukemia Patients Undergoing Hematopoietic Stem Cell Transplant IN8bio, Inc. announced completion of dosing of the first patient cohort in a Phase 1 clinical trial of INB-100, a donor-derived gamma-delta T cell therapeutic in development for patients with leukemia undergoing haploidentical stem cell transplant (HSCT). The three patients comprising the first cohort did not experience any severe adverse infusion reactions or dose limiting toxicities (DLTs) to date. The first two patients are at 14.5 months and 12.2 months, respectively, post-HSCT as of June 30, 2021, and continue to be in complete remission. The Phase 1 clinical trial (NCT03533816) is an investigator-sponsored dose escalation trial of INB-100 in patients with leukemias undergoing haploidentical HSCT being conducted at The University of Kansas Cancer Center (KU Cancer Center). Following HSCT, each patient receives a single infusion of IN8bio’s donor-derived ex-vivo, expanded, activated gamma delta T-cells. The primary endpoints of this trial are safety and tolerability, and secondary endpoints include rates of GvHD, relapse rate and overall survival. The trial consists of three dose escalation cohorts with topline data expected in 2023. Recent Insider Transactions • Aug 05
Director recently bought US$1.0m worth of stock On the 3rd of August, Emily Fairbairn bought around 100k shares on-market at roughly US$10.00 per share. This was the largest purchase by an insider in the last 3 months. This was the only on-market transaction from insiders over the last 12 months.