Forte Biosciences(FBRX) - 2023 Q4 - Annual Results

Business Highlights & Outlook Forte Biosciences advanced its lead product candidate, FB-102, into clinical trials, completing the SAD portion and initiating MAD cohorts - The primary achievement in 2023 was the clinical advancement of FB-102, a program targeting autoimmune diseases[2] - The Phase 1 trial for FB-102 successfully completed its single ascending dose (SAD) portion and has now commenced the multiple ascending dose (MAD) phase[2] 2023 Financial Performance Forte Biosciences' 2023 financial results show increased operating expenses, primarily from R&D for FB-102, resulting in a larger net loss and reduced cash reserves Operating Results Summary Research and development expenses significantly increased in 2023 due to FB-102, leading to a wider net loss per share Operating Expenses Comparison (2023 vs 2022) | Expense Category | 2023 (in millions) | 2022 (in millions) | Change (in millions) | | :--- | :--- | :--- | :--- | | Research and Development | $21.9 | $5.6 | +$16.3 | | General and Administrative | $10.6 | $8.3 | +$2.3 | Key Financial Metrics (as of Dec 31, 2023) | Metric | 2023 | 2022 | | :--- | :--- | :--- | | Net Loss per Share | ($1.00) | ($0.80) | | Cash and Cash Equivalents | $37.1 million | $41.1 million | | Common Stock Outstanding | 36.3 million shares | 21.0 million shares | Consolidated Balance Sheets Total assets decreased in 2023 primarily due to reduced cash, while liabilities slightly increased and stockholders' equity declined Balance Sheet Summary (in thousands) | Account | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $37,125 | $41,100 | | Total current assets | $38,327 | $41,511 | | Total assets | $38,980 | $41,997 | | Liabilities & Equity | | | | Total current liabilities | $3,666 | $3,179 | | Total stockholders' equity | $35,314 | $38,818 | | Total liabilities and stockholders' equity | $38,980 | $41,997 | Consolidated Statements of Operations The company reported a significantly increased net loss in 2023, driven by more than doubled total operating expenses due to intensified R&D Statement of Operations Summary (in thousands) | Line Item | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Research and development | $21,862 | $5,594 | | General and administrative | $10,624 | $8,302 | | Total operating expenses | $32,486 | $13,896 | | Loss from operations | ($32,486) | ($13,896) | | Net loss | ($31,476) | ($13,879) | | Net loss per share | ($1.00) | ($0.80) | Corporate Overview and Forward-Looking Statements Forte Biosciences, a clinical-stage biopharmaceutical company, is developing FB-102 for autoimmune diseases, while cautioning on risks related to funding, clinical development, and regulatory approval - Forte is a clinical-stage biopharmaceutical company advancing its main product candidate, FB-102[11] - FB-102 is being developed for broad autoimmune applications, with potential indications in graft-versus-host disease, vitiligo, and alopecia areata[11] - The company highlights risks related to its ability to obtain sufficient capital, clinical development uncertainties, and regulatory approval for FB-102[12]