Financial 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]

Financial Data and Key Metrics Changes - The company reported a total cash balance of $67 million, which is expected to provide runway into Q1 2027, allowing the company to achieve upcoming value-enhancing data milestones for both ALX-2004 and evorpacept [6][44]. Business Line Data and Key Metrics Changes - Significant advances were made in both evorpacept and ALX-2004 clinical programs during Q3 2025, with a focus on evorpacept's potential as a targeted oncology therapy [4][12]. - The phase two clinical trial in breast cancer is on track to dose its first patient in Q4 2025, based on strong data supporting a CD47 and HER2 biomarker-driven strategy [5][12]. Market Data and Key Metrics Changes - The addressable patient population for HER2-positive breast cancer in the second-plus-line setting is approximately 48,000, with an estimated 20,000 patients being both HER2 positive and CD47 high, representing a market opportunity of $2 billion to $4 billion [38]. Company Strategy and Development Direction - The company is pursuing a focused development strategy for evorpacept in combination with anticancer antibodies, leveraging the consistent proof of concept seen in various clinical studies [13][44]. - ALX-2004 is positioned to redefine standard care across a range of EGFR-expressing cancers, with a strong emphasis on optimizing safety and efficacy [39][44]. Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the potential of evorpacept to drive substantial benefits for patients with high CD47 expression, emphasizing the importance of this biomarker in future trials [11][44]. - The company remains focused on delivering solutions for patients with unmet needs in both HER2-positive breast cancer and EGFR-expressing cancers [44][45]. Other Important Information - The company highlighted the unique mechanism of action of evorpacept, which is designed to block the CD47 signal that cancer cells use to evade immune detection, thus enhancing the effectiveness of anticancer therapies [15][44]. - ALX-2004 has shown promising preclinical data, indicating a differentiated safety profile and potential efficacy across various cancer types [40][41]. Q&A Session Summary Question: How to correlate CD47 positivity with expression cutoffs in gastric data? - Management noted strong scientific concordance across different indications, with approximately 50% of patients expected to be CD47 high based on multiple studies [46][47]. Question: Companion diagnostic development plans? - The company is working with partners for companion diagnostics, utilizing a research-use assay for both gastric and breast cancer studies [48]. Question: Efficacy data in breast cancer trials? - Management highlighted a 56% overall response rate in patients post-Enhertu, which is significantly higher than expected benchmarks [51][52]. Question: Expectations for interim data and patient numbers? - The company anticipates good outcome data in the evorpacept trial, aiming for a response rate of 35%-40% in the breast cancer setting [56].

Q3 2025 Results November 7, 2025 NASDAQ GS ALXO Certain information set forth in this presentation contains "forward-looking information", under applicable laws collectively referred to herein as forward-looking statements. Except for statements of historical fact, information contained herein constitutes forward-looking statements and includes, but is not limited to the (i) results and cost and timing of our product development activities and clinical trials; (ii) completion of the Company's clinical trial ...

Clinical Trial Results - Evorpacept demonstrated a 65.0% objective response rate (ORR) in patients with retained HER2+ and CD47-high gastric cancer, compared to 26.1% for the control group[4] - The median duration of response (DOR) for evorpacept plus trastuzumab, ramucirumab, and paclitaxel was 25.5 months, significantly longer than the 8.4 months for the control group[4] - Progression-free survival (PFS) for the evorpacept combination was 18.4 months versus 7.0 months for the control, with a hazard ratio (HR) of 0.39[4] - The Phase 2 ASPEN-09-Breast Cancer trial is on track for first patient in (FPI) in Q4 2025, with interim data expected in Q3 2026[4] - The Phase 1 trial for ALX2004 is currently enrolling patients and is expected to deliver initial safety data in the first half of 2026[4] Financial Performance - Cash, cash equivalents, and investments as of September 30, 2025, were $66.5 million, sufficient to fund operations into Q1 2027[11] - Research and development (R&D) expenses for Q3 2025 were $17.4 million, a decrease of $9.0 million from the prior year[11] - General and administrative (G&A) expenses for Q3 2025 were $5.1 million, down from $6.1 million in the prior year[11] - GAAP net loss for Q3 2025 was ($22.1) million, or ($0.41) per share, compared to a net loss of ($30.7) million, or ($0.58) per share, in Q3 2024[11] - For the three months ended September 30, 2025, the total operating expenses were $22,532,000, a decrease of 30.8% compared to $32,567,000 for the same period in 2024[15] - The net loss for the three months ended September 30, 2025, was $22,144,000, which is a reduction of 27.8% from the net loss of $30,707,000 in the prior year[15] - The company reported a non-GAAP net loss of $19,551,000 for the three months ended September 30, 2025, compared to a non-GAAP net loss of $23,689,000 for the same period in 2024, reflecting a 17.9% improvement[19] - Cash, cash equivalents, and investments decreased to $66,464,000 as of September 30, 2025, down from $131,281,000 at the end of 2024, indicating a decline of 49.3%[17] - Total assets as of September 30, 2025, were $82,723,000, a decrease of 44.0% from $147,775,000 on December 31, 2024[17] - The accumulated deficit increased to $699,969,000 as of September 30, 2025, compared to $621,122,000 at the end of 2024, representing an increase of 12.6%[17] - Total stockholders' equity decreased to $44,800,000 as of September 30, 2025, down from $113,618,000 at the end of 2024, a decline of 60.6%[17] - Research and development expenses for the three months ended September 30, 2025, were $17,441,000, a decrease of 34.1% from $26,471,000 in the same period of 2024[15] - Interest income for the three months ended September 30, 2025, was $802,000, compared to $2,303,000 in the same period of 2024, reflecting a decrease of 65.2%[15] - The weighted-average shares of common stock used to compute net loss per share increased to 53,577,066 for the three months ended September 30, 2025, compared to 52,693,878 for the same period in 2024, an increase of 1.7%[15] Management Changes - Barbara Klencke, M.D., has been appointed as Chief Medical Officer, bringing over 30 years of experience in oncology drug development[4]

Core Insights - ALX Oncology reported financial results for Q3 2025, highlighting advancements in its clinical pipeline and financial position [1][3][13] Financial Performance - Cash, cash equivalents, and investments as of September 30, 2025, were $66.5 million, sufficient to fund operations into Q1 2027 [13][18] - R&D expenses for Q3 2025 were $17.4 million, a decrease from $26.5 million in Q3 2024, primarily due to reduced stock-based compensation and clinical development costs [13][16] - GAAP net loss for Q3 2025 was $22.1 million, or $0.41 per share, compared to a net loss of $30.7 million, or $0.58 per share, in Q3 2024 [13][16] Clinical Developments - Data from the ASPEN-06 trial showed that evorpacept combined with trastuzumab, ramucirumab, and paclitaxel achieved a 65.0% objective response rate in HER2-positive gastric cancer patients with high CD47 expression [5][6] - The Phase 2 ASPEN-09-Breast Cancer trial is set to begin enrollment in Q4 2025, evaluating evorpacept's efficacy based on CD47 expression levels [4][8] - The Phase 1 trial for ALX2004, an EGFR-targeted antibody-drug conjugate, is currently enrolling patients and is on track to deliver initial safety data in the first half of 2026 [4][9] Upcoming Milestones - Initial safety data for ALX2004 is expected in 1H 2026, with interim data for ASPEN-09-Breast Cancer anticipated in Q3 2026 [4][7] - The company appointed Barbara Klencke, M.D., as Chief Medical Officer, bringing over 30 years of experience in oncology drug development [4][8]

Core Insights - ALX Oncology plans to report its third quarter 2025 financial results and provide a business update on November 7, 2025, before market open [1] - The company will highlight data on CD47 overexpression as a potential predictive biomarker for evorpacept in HER2+ gastric cancer during the Society for Immunotherapy of Cancer (SITC) Annual Meeting [1][3] Financial Results Announcement - The financial results will be discussed in a teleconference scheduled for November 7, 2025, at 5:30 a.m. PT / 8:30 a.m. ET [2] - Access to the conference call can be made via phone or through a live audio webcast available on the company's website [2] Clinical Development - Evorpacept, the lead therapeutic candidate of ALX Oncology, is being evaluated in multiple ongoing clinical trials across various cancer indications [4] - The second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate that entered Phase 1 trials in August 2025 [4] Upcoming Presentation - A poster presentation titled "CD47 expression as a predictive biomarker for evorpacept in HER2-positive gastric/gastroesophageal cancer" will be presented at SITC on November 8, 2025 [3]

Core Insights - ALX Oncology is advancing ALX2004, a novel antibody-drug conjugate (ADC) targeting EGFR-expressing solid tumors, with promising preclinical data supporting its potential as a first-in-class treatment [1][2][6] - The ongoing Phase 1 trial for ALX2004 aims to evaluate its safety, tolerability, and preliminary efficacy, with initial safety data expected in the first half of 2026 [1][3] Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment, with a pipeline that includes ALX2004 and evorpacept [5][6] - The company utilizes proprietary technology for drug design, specifically a topoisomerase I inhibitor payload and linker platform, to enhance the therapeutic window of its ADCs [2][6] Clinical Trial Details - The Phase 1 trial (NCT07085091) for ALX2004 is an open-label multicenter study targeting patients with advanced or metastatic EGFR-expressing solid tumors [3] - Enrollment for the trial began in August 2025, and the company is on track to deliver initial safety data in early 2026 [2][3] Presentation Highlights - ALX Oncology presented extensive preclinical data and trial design for ALX2004 at the 2025 AACR-NCI-EORTC International Conference, showcasing its potential to innovate within the EGFR-targeting ADC class [1][4] - The poster presentations included detailed information on the anti-tumor activity and toxicity profile of ALX2004, emphasizing its differentiated mechanism of action [2][4]

Company Overview - Alnylam Pharmaceuticals (ALNY) is a notable stock within the Medical sector, which consists of 956 individual stocks and ranks 6 in the Zacks Sector Rank [2] - The company is part of the Medical - Biomedical and Genetics industry, which includes 470 companies and currently ranks 94 in the Zacks Industry Rank [6] Performance Metrics - Alnylam Pharmaceuticals has achieved a year-to-date return of approximately 97.6%, significantly outperforming the average return of -0.1% for Medical companies [4] - The Zacks Consensus Estimate for ALNY's full-year earnings has increased by 189.3% over the past three months, indicating improved analyst sentiment and a stronger earnings outlook [4] Comparative Analysis - Another outperforming stock in the Medical sector is ALX Oncology Holdings Inc. (ALXO), which has returned 10.8% year-to-date and has a consensus EPS estimate increase of 5.1% over the past three months [5] - Stocks in the Medical - Biomedical and Genetics industry have averaged a gain of 7.7% this year, highlighting that Alnylam Pharmaceuticals is performing better than its industry peers [6] Future Outlook - Investors interested in Medical stocks should monitor Alnylam Pharmaceuticals and ALX Oncology Holdings Inc. for potential continued strong performance [7]

Core Insights - ALX Oncology is set to present updated data from its Phase 2 ASPEN-06 trial, focusing on evorpacept as a treatment for HER2-positive gastric cancer, at the SITC 40th Annual Meeting in November 2025 [1][2] - The trial evaluates evorpacept in combination with HERCEPTIN, CYRAMZA, and paclitaxel for patients with advanced gastric cancer who have previously undergone treatment [1][3] Company Overview - ALX Oncology is a clinical-stage biotechnology company dedicated to developing novel cancer therapies aimed at extending patient lives [4] - The lead candidate, evorpacept, is being assessed in various clinical trials across multiple cancer indications, indicating its potential as a cornerstone therapy in immuno-oncology [4] - The second pipeline candidate, ALX2004, is an EGFR-targeted antibody-drug conjugate that began Phase 1 trials in August 2025 [4]

Insider Buying Summary - Recent insider buying activity indicates confidence in stock performance, with notable purchases from executives at Archrock and ALX Oncology Holdings [1] Archrock (AROC) - Jason C. Rebrook, an insider at Archrock, purchased 10,000 shares at $24.17 each, totaling an investment of $241,670 [2] - Following the purchase, AROC experienced a high of $24.77, reflecting a gain of approximately 2.5% at the peak of trading [2] - Despite this, Archrock's stock was down about 0.4% on the day of the report [2] ALX Oncology Holdings (ALXO) - CEO Jason Lettmann acquired 92,233 shares for $99,352, at a price of $1.08 each, marking his first purchase in the past year [3] - ALX Oncology Holdings saw a significant increase, trading up about 20.6% on the day of the report [3] - Lettmann's investment was up approximately 30.0% at the peak of trading, with ALXO reaching a high of $1.40 [3]