IN8bio(US:INAB)2025-11-06 21:03Clinical Trials and Product Development - The Phase 1 trial of INB-100 demonstrated 100% complete remission (CR) in acute myeloid leukemia (AML) patients, with a median follow-up of 20.1 months, and 100% progression-free survival (PFS) and overall survival (OS) rates at one year post-transplant[99] - INB-200 showed a median PFS of 16.1 months in patients receiving repeated doses, representing a 133% increase over the expected 6.9 months for standard-of-care, with preliminary data indicating improved outcomes compared to historical controls[101] - INB-619 effectively eliminated CD19+ B cells in patients with Systemic Lupus Erythematosus (SLE), demonstrating minimal release of inflammatory cytokines associated with cytokine release syndrome (CRS)[105] - INB-400's Phase 2 trial enrollment was suspended in September 2024 to conserve cash resources, while preliminary data from additional centers reported a median PFS of 10.8 months[102] - The company plans to complete enrollment of the INB-100 expansion cohort by year-end 2025 or early 2026, with long-term follow-up results anticipated in 2026[100] - INB-600, a proprietary T cell engager platform, aims to enhance immune responses against solid tumors and autoimmune diseases by selectively activating gamma-delta T cells[103] - The company introduced INB-300 and INB-500, targeting both solid and liquid tumors, with INB-500 focusing on producing gamma-delta T cells from induced pluripotent stem cells (iPSCs)[110] - The company received Orphan Drug Designation from the FDA for INB-400, covering a broad range of malignant glioma indications, including relapsed and newly diagnosed GBM[102] Financial Performance and Funding - The company has not generated any revenue since its inception in 2016 and has primarily funded operations through equity sales, including an initial public offering (IPO) and private placements[114] - As of September 30, 2025, the company has cash of $10.7 million, 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[115] - The company expects to incur additional losses in the future as it advances product candidates through clinical trials and expands its portfolio[115] - The company has raised an aggregate of $143.0 million from the sale of equity and equity-linked securities through September 30, 2025[134] - Interest income for the three months ended September 30, 2025, was $0.1 million, compared to $0 million in the same period in 2024[129] - The company plans to raise additional capital through equity and/or debt offerings and strategic collaborations to support product development[116] - Cash used in operating activities was $10.6 million for the nine months ended September 30, 2025, primarily due to a net loss of $14.5 million[152] - Cash provided by financing activities was $10.1 million during the nine months ended September 30, 2025, mainly from $8.4 million in net proceeds from the ATM program[156] - The company has not generated any product revenue since inception and does not expect to do so in the foreseeable future[145] - The company anticipates substantial increases in expenses related to ongoing activities, particularly in clinical trials and product development[142] Expenses and Cost Management - Research and development expenses for the three months ended September 30, 2025, were $2.1 million, a decrease of $1.2 million from $3.3 million in the same period in 2024[126] - General and administrative expenses for the three months ended September 30, 2025, were $1.9 million, down from $2.7 million in the prior year, reflecting a decrease in personnel-related costs[128] - Total operating expenses for the nine months ended September 30, 2025, were $14.8 million, a decrease of $9.6 million from $24.4 million in the same period in 2024[130] - Research and development expenses for the nine months ended September 30, 2025, were $7.6 million, down from $13.4 million in the prior year, primarily due to a decrease in personnel-related costs[131] Stock and Warrants - The company may receive up to $12.1 million from the exercise of outstanding common stock warrants, although there is no assurance of receiving these proceeds[116] - As of September 30, 2025, the company had issued and outstanding 248,382 pre-funded warrants, 129,296 Series A warrants, 303,574 Series B warrants, and 997,638 Series C warrants[138] - The company expects to receive up to $8.1 million from the exercise of Series C warrants and pre-funded warrants, and up to $4.1 million from Series B warrants, contingent on full cash exercise[139] - The company sold 511,057 shares under the ATM program in the three months ended September 30, 2025, generating net proceeds of approximately $1.1 million, and 1,815,346 shares in the nine months ended September 30, 2025, generating net proceeds of approximately $8.5 million[140] Regulatory and Compliance - The company adopted ASU 2023-07 effective January 1, 2025, which requires public entities to disclose significant expenses and other segment items on an interim and annual basis[164] - The company is evaluating the impact of adopting ASU 2023-09, effective for fiscal years beginning after December 15, 2024, with early adoption permitted[165] - The company qualifies as an emerging growth company (EGC) and may take advantage of reduced disclosure requirements until December 31, 2026[166] - The company will cease to be an EGC if it exceeds $1.235 billion in annual revenue or $700 million in market value of stock held by non-affiliates[167] - The company has elected not to "opt out" of the extended transition period for complying with new accounting standards, delaying adoption until standards apply to private companies[168] - The company is classified as a smaller reporting company and may continue to be so until the market value of stock held by non-affiliates is less than $250 million[169] - As a smaller reporting company, the company may present only the two most recent fiscal years of audited financial statements in its Annual Report[172] - The company is not required to provide quantitative and qualitative disclosures about market risk due to its status as a smaller reporting company[173]