IN8bio(US:INAB)2023-11-09 21:06Company Overview - Company is focused on developing gamma-delta T cell therapies for solid and liquid tumors, leveraging its DeltEx platform for advanced cancer treatment [75]. - The company has received orphan drug designation for INB-400 from the FDA, covering a range of malignant glioma indications [76]. - Preclinical data for INB-300 shows promise in targeting various solid and liquid tumors, with updates expected in 2024 [79]. - The DeltEx platform has produced hundreds of millions of iPSC-derived gamma-delta T cells, demonstrating robust cytotoxic activity against multiple cancer types [80]. - The company plans to file several IND applications for pipeline candidates over the next few years, focusing on expanding treatment indications [81]. Clinical Trials - Enrollment has begun for the Phase 2 trial of INB-400 targeting newly diagnosed glioblastoma (GBM), aiming to enroll approximately 40 patients [76]. - The Phase 1 trial of INB-100 for high-risk leukemias has completed primary enrollment, with clinical data to be presented at the ASH Annual Meeting on December 11, 2023 [78]. - INB-200 trial results suggest potential for sustained immune responses, with updated data to be presented at the SNO Annual Meeting on November 17, 2023 [87]. Financial Performance - Company has $12.9 million in cash as of September 30, 2023, which is projected to be insufficient to cover operating expenses beyond May 2024 [83]. - No revenue has been generated since inception in 2016, and future revenue is contingent on successful product development and regulatory approval [89]. - For the nine months ended September 30, 2023, total operating expenses were $22.7 million, an increase of $2.0 million from $20.7 million in the same period of 2022 [100]. - Research and development expenses for the nine months ended September 30, 2023, totaled $12.3 million, up $2.2 million from $10.1 million in the prior year, driven by a $2.0 million increase in personnel-related costs [103]. - The company raised $101.3 million in gross proceeds from the sale of securities since inception, primarily through equity offerings [106]. - The company sold 7,430,772 shares under its ATM program for net proceeds of $14.3 million during the nine months ended September 30, 2023 [108]. - Other income for the nine months ended September 30, 2023, was $0.3 million, attributed to a contractual arrangement for the transfer of clinical scale gamma-delta T cells [105]. - Net cash used in operating activities was $18.5 million for the nine months ended September 30, 2023, primarily due to a net loss of $22.4 million [123]. - Cash provided by financing activities was $13.7 million during the nine months ended September 30, 2023, mainly from the issuance and sale of common stock [128]. - Cash used in investing activities was $0.5 million for the nine months ended September 30, 2023, primarily for property and equipment purchases [126]. - The company incurred net losses and negative cash flows from operations, with a net decrease in cash and restricted cash of $5.3 million for the nine months ended September 30, 2023 [122]. - The company expects to continue financing operations through additional equity or debt financings, which may result in dilution to existing stockholders [118]. Expenses - Research and development expenses for Q3 2023 were $3.8 million, a decrease of $0.5 million from $4.3 million in Q3 2022, primarily due to a $0.9 million decrease in direct clinical costs [98]. - General and administrative expenses for Q3 2023 were $3.4 million, an increase of $0.3 million from $3.1 million in Q3 2022, mainly due to higher professional services costs [99]. - The company expects research and development expenses to continue increasing as it advances clinical development and discovers new product candidates [92]. - Research and development expenses include salaries, stock-based compensation, lab supplies, and fees paid to third parties [132]. Future Outlook - The company is exploring additional capital raising options and strategic collaborations to support ongoing research and development activities [110]. - The company may seek third-party collaborators for future commercialization of product candidates that receive marketing approval [117]. - The company is classified as a smaller reporting company and is not required to provide detailed market risk disclosures [142]. - As of September 30, 2023, the company had fixed lease payment obligations of $6.5 million, with $2.0 million payable within 12 months [120]. - The company has no long-term debt and no material non-cancelable purchase commitments with service providers [121].