ALX Oncology(ALXO) - 2025 Q2 - Quarterly Results

Executive Summary ALX Oncology reported Q2 2025 financial results and corporate updates, highlighting significant progress in evorpacept and ALX2004 clinical programs, cash runway extension, and new board appointment - ASPEN-06 trial data indicates CD47 expression as a key predictive biomarker for better evorpacept response in HER2+ gastric cancer patients; updated data to be presented in Q4 2025[1] - The Phase 2 ASPEN-Breast evorpacept trial design is updated to a single-arm study with a CD47 and HER2 biomarker-driven strategy; interim data expected in Q3 2026[1] - The ALX2004 Phase 1 clinical trial is on track to enroll its first patient in August[1] - The company focuses on advancing ASPEN-Breast and ALX2004 data milestones within its cash runway, now extended to Q1 2027[1][2] - Dr Daniel Curran appointed to the Board of Directors[1][2] Q2 2025 Highlights and Recent Developments The company achieved significant clinical and strategic progress in Q2 2025, including positive evorpacept biomarker data, revised breast cancer trial design, ALX2004 IND approval, and strategic prioritization to extend financial runway Evorpacept Clinical Program Updates ASPEN-06 Trial (HER2+ Gastric Cancer) - In a pre-planned exploratory analysis of the ASPEN-06 clinical trial, CD47 overexpression was identified as a key predictive biomarker for response and durable clinical benefit[3] ASPEN-06 Trial Results | Patient Group (n) | Combination Therapy | ORR | vs. TRP alone ORR | | :-------------------- | :------------------ | :-- | :---------------- | | HER2+, CD47-high (43) | Evorpacept + TRP | 65% | 26% | | HER2+, CD47-low (47) | Evorpacept + TRP | 39% | 25% | - In CD47-high expressing patients, evorpacept demonstrated significant benefits in Duration of Response (DOR), Progression-Free Survival (PFS), and Overall Survival (OS)[3] - The full dataset will be presented at an upcoming medical conference in Q4 2025[3] ASPEN-Breast Trial (HER2+ Breast Cancer) - Based on significant benefits in CD47-high expressing patients with HER2+ gastric cancer, the ASPEN-Breast study has been revised to a single-arm design evaluating evorpacept in all previously treated HER2-positive patients, assessed by CD47 expression[3] - The revised study design is expected to optimize enrollment and allow for an interim data readout in Q3 2026[3][6] - The goal is for these study results to support a biomarker-driven registrational study in HER2-positive breast cancer[3] UMBRELLA Study (Multiple Myeloma) - Sanofi and ALX Oncology announced the completion of the dose-escalation portion of the UMBRELLA randomized Phase 1/2 study, combining evorpacept with SARCLISA® (isatuximab-irfc) and dexamethasone in previously treated multiple myeloma patients[3] - Sanofi will initiate the dose-optimization portion of the study[3] ALX2004 Clinical Program Update (EGFR-expressing Solid Tumors) - The company received FDA IND approval in April to advance ALX2004 for clinical evaluation in epidermal growth factor receptor (EGFR)-positive solid tumors, with the first patient in the Phase 1 clinical trial expected to be dosed in August[3] - The Phase 1 dose-escalation trial will include patients with relapsed/refractory EGFR-expressing solid tumors, including non-small cell lung cancer, colorectal cancer, head and neck squamous cell carcinoma, and esophageal squamous cell carcinoma[3] - Preliminary safety data from the Phase 1 trial are anticipated in H1 2026[3][6] - ALX2004 utilizes a proprietary topoisomerase I inhibitor payload and linker-payload platform, designed to provide enhanced bystander effect and improved linker stability for targeted payload delivery[3] - Preclinical model results showed no EGFR-related skin toxicity or payload-related interstitial lung disease at clinically relevant doses, suggesting a potentially differentiated safety profile[3] Strategic Prioritizations and Cash Runway Extension - The company prioritized evorpacept development, focusing on breast cancer and pausing the ASPEN-CRC study in colorectal cancer to extend its cash runway[3] - Through these strategic prioritizations, the company extended its cash runway into Q1 2027[2][6] Corporate and Leadership Changes - Dr Daniel Curran, a physician executive with extensive experience in business development, corporate strategy, drug discovery, and development, was appointed to the Board of Directors[1][2][6] - Dr Allison Dillon, previously Chief Business Officer, was appointed Chief Operating Officer, effective immediately[6] Upcoming Clinical Milestones Key upcoming clinical milestones include ASPEN-Breast patient dosing in Q4 2025 with interim data in Q3 2026, and ALX2004 patient dosing in August with preliminary safety data in H1 2026 - ASPEN-Breast cancer: Patient dosing expected to commence in Q4 2025; interim data from this trial are anticipated in Q3 2026[6] - ALX2004: Patient dosing expected to commence in August; preliminary safety data from the Phase 1 trial in EGFR-expressing solid tumors are anticipated in H1 2026[6] Second Quarter 2025 Financial Results ALX Oncology reported a reduced net loss in Q2 2025, driven by lower R&D and G&A expenses, partially offset by an impairment charge, with cash sufficient to fund operations until Q1 2027 Financial Summary and Cash Position Cash, Cash Equivalents and Investments | Metric | Amount (June 30, 2025) | | :----------------------------------- | :--------------------- | | Cash, cash equivalents and investments | $83.5 million | - The company believes its cash, cash equivalents, and investments are sufficient to support planned operations into Q1 2027[7] Operating Expenses Analysis Research and Development (R&D) Expenses) R&D Expenses Overview | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (Millions) | | :----------- | :----------------- | :----------------- | :---------------- | | R&D Expenses | $18.0 | $34.7 | $(16.6) | - The decrease in R&D expenses was primarily due to a $8.5 million reduction in clinical and development costs (mainly from decreased clinical trial material manufacturing for evorpacept), a $4.1 million decrease in stock-based compensation, a $2.1 million reduction in personnel and related costs, and a $1.7 million decrease in preclinical costs due to pipeline prioritization[7][8] General and Administrative (G&A) Expenses) G&A Expenses Overview | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (Millions) | | :----------- | :----------------- | :----------------- | :---------------- | | G&A Expenses | $5.5 | $6.9 | $(1.4) | - The decrease in G&A expenses was primarily attributable to a reduction in stock-based compensation expense[11] Net Loss and Per Share Data Net Loss and Per Share Summary | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (Millions) | | :---------------------- | :----------------- | :----------------- | :---------------- | | GAAP Net Loss | $(25.9) | $(39.4) | $13.5 | | GAAP Net Loss per Share | $(0.49) | $(0.76) | $0.27 | | Non-GAAP Net Loss | $(23.7) | $(32.1) | $8.4 | - The decrease in net loss was primarily due to lower R&D expenses, partially offset by a $3.2 million impairment charge on long-lived assets recorded in Q2 2025, related to leased laboratory space following preclinical research staff reductions announced in March 2025[11] Condensed Consolidated Financial Statements This section presents unaudited condensed consolidated statements of operations, balance sheet data, and GAAP to non-GAAP reconciliation for the three and six months ended June 30, 2025 and 2024 Condensed Consolidated Statements of Operations Condensed Consolidated Statements of Operations (in thousands) | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $18,022 | $34,653 | $41,910 | $66,370 | | General and administrative | $5,451 | $6,872 | $13,383 | $12,917 | | Impairment charge | $3,175 | — | $3,175 | — | | Total operating expenses | $26,648 | $41,525 | $58,468 | $79,287 | | Loss from operations | $(26,648) | $(41,525) | $(58,468) | $(79,287) | | Interest income | $1,106 | $2,563 | $2,589 | $5,185 | | Interest expense | $(405) | $(429) | $(811) | $(856) | | Other (expense) income, net | $(2) | $(8) | $(13) | $(22) | | Net loss | $(25,949) | $(39,399) | $(56,703) | $(74,980) | | Net loss per share, basic and diluted | $(0.49) | $(0.76) | $(1.05) | $(1.47) | | Weighted-average shares of common stock used to compute net loss per shares, basic and diluted | 53,445,631 | 51,831,157 | 54,031,176 | 50,969,089 | Condensed Consolidated Balance Sheet Data Condensed Consolidated Balance Sheet Data (in thousands) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :----------------------------- | :------------ | :---------------- | | Cash, cash equivalents and investments | $83,546 | $131,281 | | Total assets | $95,320 | $147,775 | | Total liabilities | $30,905 | $34,157 | | Accumulated deficit | $(677,825) | $(621,122) | | Total stockholders' equity | $64,415 | $113,618 | GAAP to Non-GAAP Reconciliation GAAP to Non-GAAP Reconciliation (in thousands) | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | GAAP net loss, as reported | $(25,949) | $(39,399) | $(56,703) | $(74,980) | | Stock-based compensation expense | $2,136 | $7,252 | $7,352 | $14,283 | | Accretion of term loan discount and issuance costs | $69 | $66 | $136 | $130 | | Total adjustments | $2,205 | $7,318 | $7,488 | $14,413 | | Non-GAAP net loss | $(23,744) | $(32,081) | $(49,215) | $(60,567) | Use of Non-GAAP Financial Measures This section explains that non-GAAP financial measures provide additional information for management's business assessment but are not GAAP compliant and should not be considered in isolation or as substitutes for GAAP results - Non-GAAP financial measures provide additional information reflecting the amounts and financial basis on which management assesses and operates the business[18] - These non-GAAP financial measures are not in accordance with GAAP and should not be viewed in isolation or as a substitute for reported GAAP net loss[18] - "Non-GAAP net loss" is GAAP net loss adjusted to exclude stock-based compensation expense and accretion of term loan discount and issuance costs[19] About ALX Oncology ALX Oncology is a clinical-stage biotechnology company advancing a pipeline of novel therapies to treat cancer and extend patient lives, with evorpacept as its lead candidate and ALX2004 as its second pipeline candidate - ALX Oncology is a clinical-stage biotechnology company dedicated to advancing a pipeline of novel therapies designed to treat cancer and extend patient lives[9] - ALX Oncology's lead therapeutic candidate, evorpacept, has shown potential as a cornerstone immuno-oncology therapy and is being evaluated in multiple ongoing clinical trials across a broad range of cancer indications[9] - ALX Oncology's second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action, expected to enter Phase 1 trials in mid-2025[9] Cautionary Note Regarding Forward-Looking Statements This section warns that the press release contains forward-looking statements involving significant risks and uncertainties, where actual results may differ materially from those expressed or implied - This press release contains forward-looking statements involving significant risks and uncertainties[10] - Forward-looking statements are based on ALX Oncology's beliefs and assumptions and may involve known and unknown risks, uncertainties, and other factors that could cause ALX Oncology's actual results, performance, or achievements to differ materially from those expressed or implied[10] - Except as required by law, ALX Oncology undertakes no obligation to update such statements to reflect events or circumstances occurring after their publication date[10] Investor and Media Contacts This section provides contact information for investor relations and media inquiries - Investor Relations Contact: Elhan Webb, CFA, IR Consultant, ewebb@alxoncology.com[20] - Media Contact: Audra Friis, Sam Brown LLC, audrafriis@sambrown.com, (917) 519-9577[20]