ALX Oncology(ALXO) - 2023 Q4 - Annual Results

ALX Oncology Q4 and Full Year 2023 Results & Corporate Update ALX Oncology reports Q4 and full year 2023 financial results, corporate highlights, and clinical milestones for evorpacept Corporate Highlights and Outlook Significant 2023 growth driven by positive evorpacept trial results, capital raise, and upcoming clinical milestones - The CEO emphasized 2023 as a profound growth period, highlighted by positive randomized trial results for evorpacept in solid tumors, a first in the CD47 space[2] - The company plans to report multiple value-driving data points over the next 12-18 months from nine ongoing trials, aiming to expand evorpacept's application to breast cancer, NHL, multiple myeloma, and urothelial cancers[2] Fourth Quarter 2023 Highlights Q4 2023 highlights: leadership transition, positive ASPEN-06 interim data, and a successful $63.2 million public offering - Jason Lettmann was appointed CEO, with co-founder Jaume Pons transitioning to Chief Scientific Officer[3] ASPEN-06 Phase 2 Interim Results (Advanced Gastric/GEJ Cancer) | Metric | Evorpacept Combination Arm | Control Arm (TRP) | | :--- | :--- | :--- | | Confirmed Overall Response Rate (ORR) | 52% | 22% | | Median Duration of Response (mDOR) | Not Reached | 7.4 months | - The company executed an oversubscribed public offering, generating gross proceeds of approximately $63.2 million, extending the expected cash runway into early 2026[4][5] Anticipated 2024 Clinical Milestones ALX Oncology anticipates a catalyst-rich 2024 with multiple evorpacept data readouts and a planned Phase 3 trial in Gastric/GEJ Cancer - Key upcoming data presentations and results include: - Non-Hodgkin Lymphoma: Phase 1b data at AACR Annual Meeting (April 2024) - Urothelial Carcinoma: Phase 1b ASPEN-07 data (Q2 2024) - Gastric/GEJ Cancer: Top-line results from the full Phase 2 ASPEN-06 trial (June-July 2024) - Breast Cancer: Top-line results from the Phase 1b I-SPY TRIAL (Q4 2024) - Head and Neck Cancer: Top-line results from Phase 2 ASPEN-03 and ASPEN-04 trials (Q4 2024/Q1 2025)[6] - The company plans to initiate a Phase 3 registrational randomized clinical trial for evorpacept in Gastric/GEJ Cancer in Q4 2024[6] 2023 Full Year and Fourth Quarter Financial Results ALX Oncology concluded 2023 with $218.1 million in cash, a wider net loss due to increased R&D expenses, and a cash runway into early 2026 - As of December 31, 2023, the company held $218.1 million in cash, cash equivalents, and investments, with an additional $40 million available from a term loan, providing a cash runway into early 2026[7] Full Year Financial Comparison (2023 vs 2022, in millions) | Metric | FY 2023 ($M) | FY 2022 ($M) | | :--- | :--- | :--- | | R&D Expenses | $141.8 | $98.4 | | G&A Expenses | $28.5 | $29.0 | | GAAP Net Loss | ($160.8) | ($123.5) | | GAAP Net Loss per Share | ($3.74) | ($3.03) | Q4 Financial Comparison (2023 vs 2022, in millions) | Metric | Q4 2023 ($M) | Q4 2022 ($M) | | :--- | :--- | :--- | | R&D Expenses | $41.8 | $25.2 | | G&A Expenses | $6.2 | $7.0 | | GAAP Net Loss | ($45.5) | ($30.7) | | GAAP Net Loss per Share | ($0.93) | ($0.75) | About ALX Oncology and Evorpacept ALX Oncology develops evorpacept, a next-generation CD47 blocking therapeutic with an inactive Fc domain for improved safety and dual immune mechanism - The company's lead product, evorpacept, is a next-generation CD47 blocking therapeutic designed to bridge the innate and adaptive immune systems[12] - Evorpacept has been dosed in over 500 subjects and has shown a favorable tolerability profile across various hematologic and solid malignancies[12] - Evorpacept is rationally engineered with an inactive Fc effector function, which provides a substantially improved safety profile over other anti-CD47 molecules, allowing for higher dosing with minimal overlapping toxicity[13] - The drug's dual mechanism of action involves: 1) enabling macrophage-mediated phagocytosis when combined with anti-cancer antibodies, and 2) enabling T-cell activation by dendritic cells when combined with PD-1/PD-L1 inhibitors[13][14] Financial Statements and Non-GAAP Reconciliation Consolidated financial statements detail operating expenses, net loss, and balance sheet, with a GAAP to non-GAAP net loss reconciliation for stock-based compensation Consolidated Statements of Operations (in thousands) | Line Item | Q4 2023 | Q4 2022 | FY 2023 | FY 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $41,784 | $25,197 | $141,795 | $98,400 | | General and administrative | $6,239 | $7,022 | $28,483 | $29,036 | | Total operating expenses | $48,023 | $32,219 | $170,278 | $127,436 | | Loss from operations | ($48,023) | ($32,219) | ($170,278) | ($127,436) | | Net loss | ($45,472) | ($30,709) | ($160,805) | ($123,482) | | Net loss per share | ($0.93) | ($0.75) | ($3.74) | ($3.03) | Consolidated Balance Sheet Data (in thousands) | Line Item | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash, cash equivalents and investments | $218,147 | $282,906 | | Total assets | $242,553 | $306,489 | | Total liabilities | $52,841 | $43,025 | | Total stockholders' equity | $189,712 | $263,464 | GAAP to Non-GAAP Net Loss Reconciliation (in thousands) | Line Item | Q4 2023 | Q4 2022 | FY 2023 | FY 2022 | | :--- | :--- | :--- | :--- | :--- | | GAAP net loss | ($45,472) | ($30,709) | ($160,805) | ($123,482) | | Stock-based compensation | $6,721 | $6,295 | $26,273 | $23,839 | | Non-GAAP net loss | ($38,687) | ($24,370) | ($134,282) | ($99,599) |