Announcement • Apr 27
Instil Bio, Inc., Annual General Meeting, Jun 11, 2026 Instil Bio, Inc., Annual General Meeting, Jun 11, 2026. Location: 3963, maple avenue, suite 350, texas, dallas United States Price Target Changed • Jan 07
Price target decreased by 76% to US$29.00 Down from US$119, the current price target is an average from 2 analysts. New target price is 304% above last closing price of US$7.18. Stock is down 67% over the past year. The company is forecast to post a net loss per share of US$11.53 next year compared to a net loss per share of US$11.39 last year. New Risk • Jan 07
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 17% 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 (17% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$93m net loss in 3 years). Market cap is less than US$100m (US$83.4m market cap). Price Target Changed • Sep 14
Price target decreased by 16% to US$95.75 Down from US$114, the current price target is an average from 4 analysts. New target price is 297% above last closing price of US$24.10. Stock is down 71% over the past year. The company is forecast to post a net loss per share of US$12.22 next year compared to a net loss per share of US$11.39 last year. Recent Insider Transactions Derivative • Sep 11
CFO & Chief Business Officer notifies of intention to sell stock Sandeep Laumas intends to sell 30k shares in the next 90 days after lodging an Intent To Sell Form on the 10th of September. If the sale is conducted around the recent share price of US$23.39, it would amount to US$702k. Since June 2025, Sandeep has not owned shares directly (This sale likely refers to shares that have not yet been received). There have been no trades via on-market transactions or options from company insiders in the last 12 months. New Risk • Aug 17
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.05% 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 Share price has been highly volatile over the past 3 months (24% average weekly change). Earnings are forecast to decline by an average of 0.05% per year for the foreseeable future. Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$90m net loss in 3 years). Announcement • Jul 31
Immuneonco Biopharmaceuticals (Shanghai) Inc. Announces Preliminary Safety & Efficacy Data from the Clinical Trial Studying Imm2510, A Pd-L1xvegf Bispecific Antibody, in Front-Line Nsclc in China Instil Bio, Inc. noted that ImmuneOnco Biopharmaceuticals (Shanghai) Inc. announced preliminary safety and efficacy data from the Phase 2 open-label, multicenter study of IMM2510 (2510) in combination with chemotherapy for front-line patients with advanced non-small cell lung cancer (NSCLC) conducted in China by ImmuneOnco. As of July 1, 2025, 33 patients were dosed at 10 mg/kg, with 21 patients having at least one tumor assessment (efficacy evaluable). The majority of efficacy evaluable patients had only one tumor assessment at data cut-off. ImmuneOnco expects to present safety and efficacy data in the '2510 chemotherapy combination trial in front-line NSCLC at a future medical conference. The '2510 safety profile supports further clinical development, with no dose-limiting toxicities observed in the 33 safety evaluable patients. Announcement • Jul 02
Instil Bio, Inc. Announces U.S. F.D.A. Clearance of Investigational New Drug (IND) Application for AXN-2510 Instil Bio, Inc. announced the clearance of an Investigational New Drug (IND) application for AXN-2510 (2510) by the U.S. Food and Drug Administration. Instil expects to initiate a phase 1 trial of '2510 as monotherapy for patients with relapsed/refractory solid tumors before the end of 2025. The trial is designed to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of '2510 in patients with solid tumors. Additionally, Instil continues to anticipate that initial safety and efficacy results from the ongoing phase 2 study of '2510 in combination with chemotherapy in first-line NSCLC in China will be shared in the second half of 2025 by ImmuneOnco. Announcement • Jun 11
Instil Bio, Inc. Announces the Addition of John Maraganore, Ph.D., to the Board of Directors of Axion Bio, Inc., Its Wholly-Owned Subsidiary Instil Bio, Inc. announced the addition of John Maraganore, Ph.D., to the Board of Directors of Axion Bio, Inc., its wholly-owned subsidiary. Dr. Maraganore is a seasoned biotechnology executive with over 30 years of experience in building and leading innovative life sciences companies. He was the founding CEO of Alnylam Pharmaceuticals, where he led the company from its inception in 2002 through nearly two decades of growth. Dr. Maraganore’s passion and hard work advanced RNA interference (RNAi) from a nascent platform into a validated therapeutic modality, bringing multiple first-in-class RNAi medicines to market. He currently serves on the boards of several public and private biotech companies focused on areas such as oncology, immunology, and precision medicine, and advises leading investment firms in the life sciences sector. His breadth of experience across drug discovery, clinical development, and strategic partnering makes him an invaluable partner in guiding the advancement of next-generation cancer therapies. Announcement • Jun 04
Instil Bio, Inc Announces Appointment of Jamie Freedman as Chief Medical Officer Instil Bio, Inc. announced the appointment of Jamie Freedman, M.D., Ph.D., as Chief Medical Officer. Dr. Freedman brings deep experience in oncology drug development and other therapeutic areas, and a track record of leading programs through all phases of development, regulatory approval and commercialization. Jamie Freedman is a Hematologist-Oncologist and seasoned biopharmaceutical executive with over 20 years of leadership experience in biopharma drug development. Dr. Freedman has held executive roles at leading pharmaceutical companies including Genentech, AstraZeneca, GSK, and Merck in clinical development, in medical affairs, as oncology business head, and as country-level general manager. Dr. Freedman’s career has led to 15 drug approvals and successful launches across multiple therapeutic areas. He received M.D. and Ph.D. degrees from Tufts University and trained in Medicine and Hematology-Oncology at the University of California, San Francisco, and Harvard University, respectively. He is also passionate about health equity having pioneered some of the first dedicated inclusive trials for underserved and underrepresented patients in the US and Africa. He continues to see patients with blood and solid tumor cancers at the UCSF VA Medical Center where he is also on staff as an adjunct faculty member. Announcement • May 22
Instil Bio, Inc. and ImmuneOnco Biopharmaceuticals (Shanghai) Inc. Announces the Phase 2 Trial in First-Line NSCLC of IMM2510 Instil Bio, Inc. and ImmuneOnco Biopharmaceuticals (Shanghai) Inc. announced clinical trial updates of '2510 and NSCLC clinical development strategy. Instil's Phase 1b/2 trial of '2510 in the United States is expected to be initiated before the end of 2025, assuming the necessary regulatory approvals are obtained. The trial is expected to be a monotherapy dose optimization trial in relapsed/refractory solid tumors, which is intended to bridge the doses to the ongoing China trials and replaces the previously planned US '2510 and chemotherapy combination trial in first-line NSCLC. Announcement • Apr 16
Instil Bio, Inc., Annual General Meeting, May 28, 2025 Instil Bio, Inc., Annual General Meeting, May 28, 2025. Location: 3963 maple avenue, suite 350, texas 75219, dallas United States New Risk • Apr 06
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$95.3m This is considered a minor 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 Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings are forecast to decline by an average of 7.4% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$107m net loss in 3 years). Market cap is less than US$100m (US$95.3m market cap). New Risk • Mar 30
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 17% 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 (17% average weekly change). Earnings are forecast to decline by an average of 7.4% per year for the foreseeable future. Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$107m net loss in 3 years). Breakeven Date Change • Mar 06
No longer forecast to breakeven The 4 analysts covering Instil Bio no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$600.0k in 2027. New consensus forecast suggests the company will make a loss of US$106.5m in 2027. New Risk • Mar 05
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 7.4% 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 7.4% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$107m net loss in 3 years). Share price has been volatile over the past 3 months (17% average weekly change). Announcement • Jan 14
Instil Bio Announces Clinical Progress in China for IMM2510/SYN-2510, a Clinical-Stage PD-L1xVEGF Bispecific Antibody Instil Bio, Inc. announced clinical progress of IMM2510/SYN-2510 in China by its collaborator, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. ImmuneOnco announced that the first patient has been dosed in its phase 1b/2 clinical trial of IMM2510/SYN-2510 in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) in China. ImmuneOnco announced it plans to enroll first-line patients in this trial and anticipates presenting initial clinical data, including data for first-line NSCLC patients, from this trial as soon as the second half of 2025. Additionally, Instil announced that for its anticipated initial U.S. clinical trial of SYN-2510/IMM2510 in lung cancer, it plans to target enrollment of first-line patients with NSCLC in combination with chemotherapy with an expected initiation in the second half of 2025, assuming the necessary regulatory approvals are obtained. About SYN-2510/IMM2510: SYN-2510/IMM2510 is a PD-L1xVEGF bispecific antibody in development for the treatment of multiple solid tumor cancers. SYN-2510/IMM2510 is differentiated from other PD-(L)1xVEGF bispecific antibodies by its VEGF trap, which binds multiple VEGF receptor ligands beyond VEGF-A, a bispecific structure which leverages PD-L1 as an anchor in the tumor microenvironment (TME), and enhanced antibody-dependent cellular cytotoxicity (ADCC) to direct killing of PD-L1-positive tumor cells. Price Target Changed • Jan 07
Price target increased by 10.0% to US$114 Up from US$104, the current price target is an average from 3 analysts. New target price is 388% above last closing price of US$23.37. Stock is up 204% over the past year. The company is forecast to post a net loss per share of US$12.72 next year compared to a net loss per share of US$24.00 last year. Breakeven Date Change • Dec 31
Forecast to breakeven in 2027 The 4 analysts covering Instil Bio expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$600.0k in 2027. Average annual earnings growth of 54% is required to achieve expected profit on schedule. New Risk • Sep 10
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 19% 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 (19% average weekly change). Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$4.3m net loss in 3 years). Board Change • Apr 16
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. No highly experienced directors. Independent Non-Employee Director Gwen Binder was the last director to join the board, commencing their role in 2020. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Jan 17
Instil Bio, Inc. Announces the Closure of Its UK Manufacturing and Clinical Operations Instil Bio, Inc. announced a strategic update. Instil has entered into an agreement with a collaborator that has a successful track record of manufacturing and dosing patients with cell therapies to conduct preclinical manufacturing feasibility studies in the ITIL-306 program. With the objective of saving costs and improving time efficiency, the company is announcing the closure of its UK manufacturing and clinical operations, thereby reducing its UK workforce which is expected to be substantially completed by the first half of 2024. Board Change • Aug 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. No highly experienced directors. Independent Non-Employee Director Gwen Binder was the last director to join the board, commencing their role in 2020. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Jun 29
Instil Bio, Inc. Announces Oral Presentation of ITIL-306 Preclinical Data at British Society for Gene and Cell Therapy Annual Conference Instil Bio, Inc. reported an oral presentation at the British Society for Gene and Cell Therapy Annual Conference, demonstrating that its proprietary CoStimulatory Antigen Receptor (CoStAR) platform enhances activity of TILs against autologous tumor. The presentation highlighted CoStAR’s unique mechanism of action which results in greatly enhanced activity of TILs when activation occurs through both the native TCR and engineered CoStAR receptors. Additionally, novel data demonstrated that Instil’s FRa-CoStAR enhances activity of TILs against autologous tumors with varied expression of FRa including ovarian, renal, and non-small cell lung cancer tumors. The robust activity of NSCLC, ovarian, and renal carcinoma CoStAR-TILs against autologous tumor exceeded that of genetically unmodified melanoma TILs, as measured by secretion of IFN?. Announcement • Jan 10
Instil Bio Announces Resumption of Clinical Trial of Costar-Til Candidate Itil-306 in Lung, Ovarian, and Renal Cancer Instil Bio, Inc. announced the resumption of its Phase 1 clinical trial of ITIL-306 for the treatment of non-small cell lung cancer (NSCLC), ovarian cancer, and renal cell carcinoma (RCC). With the resumption of the ITIL-306 Phase 1 study, the Company expects to release initial safety, translational, and efficacy data from dose escalation cohorts at a medical conference in 2023. The trial was resumed after the implementation of additional quality safeguards designed to further protect the manufacturing process from potential contaminants. Following its recent reprioritization of clinical programs and corporate restructuring, Instil expects its cash runway to extend into 2025, excluding the potential financing or other monetization of its Tarzana manufacturing site. Instil intends to provide further updates on its pre-clinical pipeline in 2023, including the potential to nominate additional CoStAR candidates and novel TIL technologies for clinical development. Announcement • Nov 16
Instil Bio, Inc. Announces Executive Changes Instil Bio, Inc. announced Appointment of cell therapy pioneer Dr. Robert Hawkins as Head of Research and Development, and resignation of Chief Medical Officer, Dr. Zachary Roberts. Appointment of Head of Research nd Development: Instil announced the appointment of Robert Hawkins, M.B.B.S. Ph.D., as Head of Research and Development. Dr. Hawkins is a world-renowned oncologist and biotechnology innovator, with a focus on development of novel cell and gene therapies. Dr. Hawkins was the founder and CEO of Immetacyte Ltd., a cell therapy company spun out of the University of Manchester where Dr. Hawkins served as Professor of Medical Oncology. Immetacyte Ltd. generated the foundational TIL technology and clinical data on which Instil was founded. Resignation of Chief Medical Officer: Instil announced that, pursuant to a separation agreement, Zachary Roberts, M.D., Ph.D., Chief Medical Officer of the Company, has resigned effective November 11, 2022 to pursue other opportunities. The company appreciates Dr. Roberts’ contributions and wishes him the best in his future endeavors. Price Target Changed • Nov 16
Price target decreased to US$14.50 Down from US$21.00, the current price target is an average from 4 analysts. New target price is 587% above last closing price of US$2.11. Stock is down 90% over the past year. The company is forecast to post a net loss per share of US$1.77 next year compared to a net loss per share of US$1.48 last year. Price Target Changed • Nov 01
Price target decreased to US$18.00 Down from US$21.00, the current price target is an average from 3 analysts. New target price is 445% above last closing price of US$3.30. Stock is down 85% over the past year. The company is forecast to post a net loss per share of US$1.77 next year compared to a net loss per share of US$1.48 last year. Announcement • Oct 19
Instil Bio Announces First Patient Dosed with ITIL-306, First Engineered TIL Therapy Using the CoStAR Platform Targeting Folate Receptor Alpha (FRa), in Non-Small Cell Lung Cancer Instil Bio, Inc. announced that the first patient has been dosed in a Phase 1 dose escalation study of ITIL-306 (NCT05397093) for the treatment of multiple solid tumors. ITIL-306 is Instil’s first genetically-engineered Costimulatory Antigen Receptor-TIL (CoStAR-TIL) therapy. Instil’s first-in-human Phase 1 study of ITIL-306 is an open-label, multicenter study in patients with non-small cell lung cancer, ovarian cancer, and renal cell carcinoma. Patients in the first dose cohort will receive a target dose of one billion CoStAR-transduced TILs after receiving a reduced intensity lymphodepletion regimen and no post-infusion interleukin-2. The study will evaluate safety of ITIL-306 in addition to efficacy and translational endpoints. The company anticipates reporting initial clinical data from the Phase 1 trial in 2023. ITIL-306 is an autologous TIL cell therapy engineered with a novel and proprietary CoStAR molecule that is activated by folate receptor alpha (FRa) to provide robust costimulatory signals within the tumor microenvironment. CoStAR builds on the key advantages of native TILs to enhance the cytokine release, cytolytic activity, and proliferation of TILs in the tumor microenvironment. Previously published preclinical data demonstrates the ability of CoStAR-T cells to enhance tumor control in vivo in the absence of exogenous IL-2, supporting a treatment regimen free of IL-2 in the Phase 1 study of ITIL-306. Announcement • Sep 07
Instil Bio, Inc. Appoints Tim Moore as Chief Operating Officer Instil Bio, Inc. announced the appointment of Tim Moore to the role of Chief Operating Officer. Tim Moore has more than three decades of leadership experience in biopharmaceutical manufacturing and operations, including at Genentech, Kite and most recently PACT Pharma. From 2016 to 2019, Mr. Moore was Executive Vice President, Technical Operations at Kite Pharma, where he was responsible for technical operations and successfully launched Yescarta®, one of the first FDA-approved CAR-T cell therapies. Prior to Instil, Mr. Moore was the President and Chief Operating Officer of PACT Pharma, a cell therapy company focusing on neo-antigen directed TCR-T cell therapy. Tim Moore Biography: Prior to joining Instil Bio, Mr. Moore served as the President and Chief Operating Officer at PACT Pharma since April of 2020, and as the company’s President and Chief Technology Officer since October of 2019. Before joining PACT, he served as Executive Vice President, Technical Operations at Kite, a Gilead Company, since March of 2016. During this time Mr. Moore was responsible for overseeing the process development, manufacturing, quality and supply chain for the launch of Yescarta®, one of the first CAR T therapies to be developed, manufactured and commercialized, as well as advancement of the Kite pipeline. In addition, Mr. Moore globally expanded the biopharmaceutical operations to serve and support the US and EU as well as key partners in Asia. Prior to Kite, Mr. Moore served as the Senior Vice President, Head of Global Technical Operations – Biologics of Genentech, Inc. and as a member of the Genentech Executive Committee since 2010. In this role, Mr. Moore oversaw global leadership for more than 7,500 professionals across 10 internal sites and over 37 contract manufacturing organizations, as well as global manufacturing and end-to-end quality supply performance of more than 20 biological product families. Prior to that, Mr. Moore was Genentech’s Senior Vice President, Global Supply Chain and Global Engineering from 2007 to 2010. Previously, Mr. Moore served as Vice President, Operations at ZLB Behring (formerly Aventis Behring). He is currently a member of ISPE, PDA and has been a part of the Executive Committee of BioPhorum and serves as a Board member for Cerus and BioLife Solutions. Mr. Moore received a B.S. in Chemical Engineering from Tulsa University and a M.S. in Engineering Management from Northwestern University. Price Target Changed • Aug 23
Price target decreased to US$22.00 Down from US$24.75, the current price target is an average from 3 analysts. New target price is 314% above last closing price of US$5.32. Stock is down 70% over the past year. The company is forecast to post a net loss per share of US$1.81 next year compared to a net loss per share of US$1.48 last year. Announcement • May 28
Instil Bio, Inc. Announces IND Clearance of First CoStAR-TIL Program, ITIL-306, Designed to Enhance Activity in the Tumor Microenvironment Instil Bio, Inc. announced IND clearance by the U.S. Food and Drug Administration of ITIL-306, Instil’s first genetically-engineered Costimulatory Antigen Receptor TIL (CoStAR-TIL) therapy, as well as the presentation of supporting in vivo CoStAR data at the 2022 ASCO Annual Meeting. ITIL-306 is an autologous TIL cell therapy engineered with a novel and proprietary Costimulatory Antigen Receptor (CoStAR) that is activated by folate receptor alpha (FRa) to provide robust costimulatory signals. CoStAR builds on the key advantages of native TILs, including their polyclonal anti-tumor reactivity, to enhance the cytokine release, cytolytic activity, and proliferation of TILs in the tumor microenvironment. The design of Instil’s first-in-human Phase 1 study of ITIL-306 will enroll patients with non-small cell lung cancer (NSCLC), ovarian cancer, and renal cell carcinoma (RCC) and will start with a dose of one billion CoStAR-transduced TILs. Manufacturing for ITIL-306 will occur at Instil’s Tarzana, California manufacturing facility. The poster presentation at the 2022 ASCO Annual Meeting will outline findings from studies evaluating anti-FOLR1 CoStAR T cells in vitro as well as a mouse solid tumor model in vivo. The poster presentation highlights results demonstrating enhanced T cell function and tumor control by CoStAR-modified T cells. Importantly, improved tumor control in a mouse solid tumor model occurred without exogenous IL-2 administration, supporting a clinical CoStAR-TIL regimen free of high-dose IL-2. CoStAR T cells showed limited upregulation of PD-1 after target exposure and demonstrated improved persistence in vivo. Price Target Changed • May 27
Price target decreased to US$26.00 Down from US$28.00, the current price target is an average from 2 analysts. New target price is 333% above last closing price of US$6.00. Stock is down 66% over the past year. The company is forecast to post a net loss per share of US$1.74 next year compared to a net loss per share of US$1.48 last year. Price Target Changed • May 24
Price target decreased to US$27.75 Down from US$30.00, the current price target is an average from 2 analysts. New target price is 243% above last closing price of US$8.09. Stock is down 52% over the past year. The company is forecast to post a net loss per share of US$1.74 next year compared to a net loss per share of US$1.48 last year. Price Target Changed • Apr 27
Price target decreased to US$26.67 Down from US$30.00, the current price target is an average from 3 analysts. New target price is 228% above last closing price of US$8.14. Stock is down 55% over the past year. The company is forecast to post a net loss per share of US$1.65 next year compared to a net loss per share of US$1.48 last year. Announcement • Apr 02
Instil Bio, Inc., Annual General Meeting, May 20, 2022 Instil Bio, Inc., Annual General Meeting, May 20, 2022, at 09:00 Central Standard Time. Location: 3963 Maple Avenue Suite 350 Dallas Texas United States Agenda: To consider election of the Board’s nominees, Bronson Crouch and Jack Nielsen, to the board of directors; to ratify the selection by the Audit Committee of the board of directors of Deloitte & Touche LLP as the independent registered public accounting firm of the company for the year ending December 31, 2022; and to conduct any other business properly brought before the meeting. Announcement • Sep 19
Instil Bio Presents Subset Analysis of Patients with Checkpoint-Refractory Advanced Melanoma from Compassionate Use Study at 2021 ESMO Congress Instil Bio, Inc. announced that a subset analysis of treatment outcomes with unselected autologous tumor infiltrating lymphocytes (TILs) in patients with checkpoint inhibitor-refractory advanced cutaneous melanoma was presented at the 2021 European Society for Medical Oncology (ESMO) Congress, taking place virtually from September 16-21, 2021. Among the 12 patients featured in this subset analysis who had disease progression following treatment with a PD-1 inhibitor, all were also resistant to CTLA-4 inhibition with ipilimumab. Seven (58%) patients achieved an objective response, with 1 (8%) achieving a complete response. With a median duration of follow-up of 45.5 months, the median overall survival was 21.3 months with nearly half of patients experiencing long term survival. Side effects of treatment were largely transient, manageable with supportive care, and generally attributable to the lymphodepleting chemotherapy regimen and post-TIL high-dose IL-2 treatment. Outcomes in this highly treatment-refractory subgroup were similar to those observed in all 21 treated patients, with high response rates and an expected safety profile. Announcement • Sep 15
Instil Bio Receives IND Clearance to Initiate a Phase 2 Clinical Trial for Patients with Advanced Melanoma Instil Bio, Inc. reported clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate DELTA-1, a global Phase 2 clinical trial of ITIL-168 in patients with advanced melanoma whose disease has relapsed after a PD-1 inhibitor and, if positive for a BRAF-activating mutation, a BRAF inhibitor. The DELTA-1 trial was expanded during the IND review process, in consultation with FDA, to include additional populations of patients with advanced melanoma. Cohorts 2 and 3 will enroll patients who discontinued PD-1 inhibitor therapy due to intolerable toxicity and patients who had an unsatisfactory response to prior PD-1 inhibitor but have not yet experienced disease progression, respectively. Topline safety and efficacy results are expected in 2023 and, if positive, are anticipated to support the submission of a biologics license application (BLA) to the FDA in 2023 and a Marketing Authorization Application (MAA) to the European Medicines Agency in 2024. ITIL-168 is an investigational, autologous cell therapy made from tumor infiltrating lymphocytes, or TILs. Made from each patient’s digested and cryopreserved tumor, ITIL-168 is a TIL cell therapy manufactured to offer an unrestricted T cell receptor (TCR) repertoire. Instil’s proprietary, optimized, and scalable manufacturing process has been designed to capture and preserve the maximum diversity of each patient’s TILs. By collecting the patient’s tumor and immediately processing and then cryopreserving it, process offers significant scheduling flexibility for patients and physicians at the time of both tumor resection and TIL treatment. In addition to DELTA-1, Instil plans to investigate ITIL-168 in additional solid tumor indications in Phase 1 clinical trials beginning in 2022. DELTA-1 is a global, multicenter Phase 2 clinical trial of ITIL-168 in adult patients with advanced melanoma. Using an open-label, single-arm design, the main study cohort will evaluate the efficacy and safety of ITIL-168, when administered after a 5-day course of lymphodepleting chemotherapy and followed by up to 8 doses of high-dose interleukin-2 (IL-2), in patients whose cancer has progressed following a PD-1 inhibitor and, if positive for a BRAF-activating mutation, a BRAF inhibitor. Approximately 80 subjects are planned for enrollment and treatment in Cohort 1. Cohort 2 is anticipated to enroll approximately 25 subjects and is designed to evaluate the efficacy and safety of the regimen in patients who required discontinuation of PD-1 inhibitor(s) due to unacceptable toxicity, regardless of best overall disease response. Cohort 3 is also anticipated to enroll approximately 25 subjects and will evaluate efficacy and safety in patients whose best ongoing response to PD-1 inhibitor(s) is stable disease. Patients in Cohorts 2 and 3 whose cancer expresses a BRAF-activating mutation will be required to have experienced disease progression following BRAF inhibitor therapy. The primary endpoint of DELTA-1 is the objective response rate (ORR) according to RECIST v1.1 as assessed by independent central review. Secondary endpoints include disease control rate, duration of response, progression-free survival, overall survival, and safety. Announcement • Mar 19
Instil Bio, Inc. has completed an IPO in the amount of $320 million. Instil Bio, Inc. has completed an IPO in the amount of $320 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 16,000,000
Price\Range: $20
Transaction Features: Reserved Share Offering; Sponsor Backed Offering