ALX Oncology(US:ALXO)2025-11-07 21:01Financial Performance - Total current assets decreased from $134,352,000 as of December 31, 2024, to $66,516,000 as of September 30, 2025, a decline of approximately 50.5%[16] - Net loss for the three months ended September 30, 2025, was $22,144,000, compared to a net loss of $30,707,000 for the same period in 2024, representing a 27.8% improvement[21] - Net loss per share for the three months ended September 30, 2025, was $0.41, an improvement from $0.58 in the same period of 2024[18] - For the nine months ended September 30, 2025, the net loss was $78,847, a decrease of 25.4% compared to a net loss of $105,687 for the same period in 2024[47] - The net loss for the three months ended September 30, 2025, was $22.144 million, with a net loss per share of $(0.41)[87] - The company incurred net losses of $22.1 million and $30.7 million for the three months ended September 30, 2025, and 2024, respectively, with an accumulated deficit of $700.0 million as of September 30, 2025[179] Expenses - Research and development expenses for the three months ended September 30, 2025, were $17,441,000, down 34% from $26,471,000 in the same period of 2024[18] - Total operating expenses for the nine months ended September 30, 2025, were $81,000,000, down 27.6% from $111,854,000 for the same period in 2024[18] - General and administrative expenses for Q3 2025 were $5.1 million, a decrease of 16% from $6.1 million in Q3 2024[135] - General and administrative expenses for the nine months ended September 30, 2025, were $18.5 million, a decrease of 3% from $19.0 million in the same period of 2024[136] - The Company recognized total stock-based compensation expense of $2.521 million for the three months ended September 30, 2025, and $9.873 million for the nine months ended September 30, 2025[82] Assets and Liabilities - Total liabilities increased from $34,157,000 as of December 31, 2024, to $37,923,000 as of September 30, 2025, an increase of approximately 8.2%[16] - Cash and cash equivalents increased from $17,567,000 as of December 31, 2024, to $23,442,000 as of September 30, 2025, an increase of approximately 33.5%[16] - The total stockholders' equity decreased from $113,618,000 as of December 31, 2024, to $44,800,000 as of September 30, 2025, a decline of approximately 60.6%[16] - The total accrued expenses and other current liabilities increased to $16,791,000 as of September 30, 2025, from $13,419,000 as of December 31, 2024[61] - The company reported accrued clinical and nonclinical study costs of $10,184,000 as of September 30, 2025, compared to $3,858,000 as of December 31, 2024, indicating a significant increase[61] Cash Flow - The company reported a net cash used in operating activities of $65,162 for the nine months ended September 30, 2025, compared to $89,866 for the same period in 2024, reflecting a 27.6% improvement[47] - The total cash, cash equivalents, and restricted cash increased by $5,875 during the nine months ended September 30, 2025, compared to a decrease of $6,304 in the same period of 2024[47] - The company experienced a net increase in cash, cash equivalents, and restricted cash of $5.9 million for the nine months ended September 30, 2025[154] - The company reported a net cash provided by investing activities of $71.4 million for the nine months ended September 30, 2025, primarily from cash received for maturities of investments of $117.1 million[157] Capital Raising and Financing - The company raised $372 from an ATM offering, net of commissions, compared to $29,302 in the previous year[47] - The Company entered into a secured term loan facility of up to $100.0 million, drawing an initial loan of $10.0 million, with an additional $40.0 million available until June 2024[67] - The Company issued approximately 2,404,855 shares of common stock under its at-the-market equity offering program for net proceeds of $30.0 million as of September 30, 2025[73] - The company completed an underwritten follow-on public offering in October 2023, raising approximately $58.9 million in net proceeds[149] - The company expects to finance operations through equity offerings, debt financings, and collaborations until substantial product revenue is generated[143] Clinical Development - The Company is advancing two clinical-stage product candidates: evorpacept and ALX2004, with evorpacept being evaluated in multiple clinical trials[97] - Evorpacept demonstrated a 65.0% objective response rate (ORR) in patients with retained HER2-positive and CD47-high gastric cancer, compared to 26.1% for the control group[101] - The median duration of response (mDOR) for Evo-TRP was 25.5 months versus 8.4 months for the control group in the same patient population[101] - Treatment with Evo-TRP resulted in a progression-free survival (PFS) of 18.4 months compared to 7.0 months for the control group, with a hazard ratio (HR) of 0.39[101] - The company has not realized product revenues from its planned principal operations as of September 30, 2025[33] Risks and Challenges - The company expects to continue incurring significant operating losses for the foreseeable future, with expenses likely to increase due to ongoing clinical trials and development efforts[180] - The company may never generate significant revenue or achieve profitability, which could impair its ability to maintain research and development efforts[189] - Clinical trial enrollment difficulties may lead to significant delays in regulatory submissions and marketing approvals[206] - The COVID-19 pandemic has adversely impacted clinical trial enrollment, with ongoing challenges expected[207] - The company may face significant delays in clinical trials due to various unforeseen events, which could impact the ability to obtain marketing approval[202]