IN8bio(US:INAB)2025-08-07 20:11Clinical Trial Results - INB-100 demonstrated 100% complete remission (CR) in acute myeloid leukemia (AML) patients with a median follow-up of 20.1 months, surpassing real-world control groups with 67.8% progression-free survival (PFS) and 74.7% overall survival (OS) at one year [100]. - INB-200 achieved a median PFS of 16.1 months, a 133% increase over the expected 6.9 months for standard-of-care, with 40% of patients remaining progression-free for over 18 months [101][108]. - INB-619 showed complete targeted depletion of harmful B cells in lupus samples without significant inflammatory cytokines, indicating a safer immunotherapy alternative [105][108]. - The company is currently enrolling an expansion cohort for INB-100, targeting up to 15 additional patients to confirm improvements in relapse-free and OS [100]. - INB-600, a proprietary T cell engager platform, aims to enhance anti-tumor responses while minimizing risks of cytokine release syndrome (CRS) [103]. - The company presented preclinical data for INB-300, demonstrating proof-of-concept against leukemia antigen targets CD33 and CD123, indicating potential for distinguishing tumor from healthy tissue [107]. - As of May 31, 2025, patients receiving repeated doses of INB-200 showed a median PFS of 10.8 months in a multi-center trial, with additional data expected later this year [102]. - The company expects to present further preclinical data for the INB-600 platform in the second half of 2025, indicating ongoing development and potential applications [106]. Financial Performance - As of June 30, 2025, the company has $13.2 million in cash, which is not anticipated to fund projected operating expenses for at least 12 months, raising substantial doubt about its ability to continue as a going concern [111]. - Total operating expenses for the three months ended June 30, 2025, were $5.2 million, a decrease of $3.5 million compared to $8.7 million for the same period in 2024 [123]. - Research and development expenses decreased to $2.5 million for the three months ended June 30, 2025, from $5.2 million in the prior year, primarily due to a $1.3 million decrease in personnel-related costs [124]. - General and administrative expenses were $2.7 million for the three months ended June 30, 2025, down from $3.5 million in the same period in 2024, reflecting cost savings in personnel and professional services [125]. - The company has not generated any revenue since inception and does not expect to do so in the foreseeable future [116]. - The company expects to incur additional losses as it advances product candidates through clinical trials and expands its portfolio [111]. - Interest income for the three months ended June 30, 2025, was $0.1 million, an increase of $0.05 million compared to the same period in 2024 [126]. - For the six months ended June 30, 2025, total operating expenses were $10.9 million, a decrease of $6.5 million from $17.3 million in 2024 [127]. - Research and development expenses decreased to $5.5 million for the six months ended June 30, 2025, down from $10.1 million in the prior year, a reduction of $4.6 million [128]. - General and administrative expenses were $5.4 million for the six months ended June 30, 2025, compared to $7.3 million in the prior year, reflecting a decrease of $1.9 million [129]. - As of June 30, 2025, the company had cash of $13.2 million, which is expected to fund operations into June 2026 [132]. - The company raised an aggregate of $139.6 million from the sale of equity and equity-linked securities through June 30, 2025 [131]. - Net cash used in operating activities was $7.0 million for the six months ended June 30, 2025, primarily due to a net loss of $10.6 million [150]. - The company sold 1,304,289 shares under the ATM program during the six months ended June 30, 2025, resulting in net proceeds of approximately $7.4 million [139]. - The company expects substantial increases in expenses contingent on additional funding for ongoing activities, particularly for clinical trials [140]. - As of June 30, 2025, the company had fixed lease payment obligations of $3.8 million, with $1.4 million payable within 12 months [147]. - The company has not generated any product revenue and has incurred net losses and negative cash flows from operations since inception [143]. - The company may receive up to $9.8 million from the exercise of outstanding warrants, assuming full cash exercise [136]. - Cash used in operating activities was $14.0 million for the six months ended June 30, 2024, primarily due to a net loss of $17.2 million [151]. - Non-cash charges included $2.4 million in stock-based compensation, reflecting increased employee headcount [152]. - Cash used in investing activities was $0.2 million during the six months ended June 30, 2024, mainly for property and equipment purchases [153]. - Cash provided by financing activities was $3.1 million for the six months ended June 30, 2024, primarily from the issuance of common stock [155]. - Cash provided by financing activities was $9.2 million for the six months ended June 30, 2025, primarily from the ATM program [154]. Corporate Governance and Compliance - The company adopted ASU 2023-07 effective January 1, 2025, which requires enhanced disclosures about reportable segments [163]. - The company qualifies as an emerging growth company (EGC) and can take advantage of reduced disclosure requirements until December 31, 2026 [165]. - The company is also classified as a smaller reporting company, allowing it to present only the two most recent fiscal years of audited financial statements [170]. - Research and development expenses include salaries, stock-based compensation, and lab supplies, with all costs expensed as incurred [159]. - The company has not experienced material adjustments to prior estimates of accrued research and development expenses [161]. Operational Adjustments - The company plans to implement cash preservation measures, including workforce reduction and prioritization of its pipeline, to address liquidity needs [112]. - The company executed a one-for-thirty reverse stock split on June 5, 2025, adjusting the per share exercise price and number of shares issuable under outstanding options and warrants [114].