- Combination of evorpacept plus rituximab and lenalidomide (R2) generated complete responses (CR) in 92% of patients with untreated indolent non-Hodgkin lymphoma (iNHL) comparing favorably to an approximate 50% historical CR rate for R2 alone - Data indicates combination of evorpacept plus R2 was well-tolerated and provides impressive anti-tumor activity in frontline treatment setting - While longer follow up matures, minimal residual disease (MRD) eradication rate with this novel regimen will be evaluat ...

Summary of ALX Oncology Holdings FY Conference Call Company Overview - **Company**: ALX Oncology Holdings (NasdaqGS:ALXO) - **Founded**: 2015 - **Lead Program**: Evorpacept, a CD47 blocker with a unique mechanism of action - **New Program**: ALX 2004, an EGFR-targeted antibody-drug conjugate (ADC) currently in clinical trials [2][4] Core Points and Arguments CD47 Mechanism and Evorpacept - Evorpacept is designed to block the "don't eat me" signal from CD47, which is crucial for immune evasion by cancer cells [2][3] - The company claims to be the only CD47 blocker in development with a dead Fc, allowing for full blockade of the "eat me" signal [3] - The approach has been validated through four clinical studies, demonstrating its potential effectiveness [3] Clinical Trials and Results - **Gastric Cancer Trial**: - Phase 2 trial showed a 41% overall response rate (ORR) for evorpacept plus TRP compared to 26% in the control arm [9] - In patients retaining HER2 positivity, the response rate was 49% versus 25% in the control arm, with a median duration of response of 15.7 months [11] - The FDA did not grant accelerated approval due to the availability of Enhertu, leading the company to refocus on breast cancer [9][11] - **Breast Cancer Studies**: - The company is advancing a study combining evorpacept with Herceptin and chemotherapy, with interim data expected in Q3 2026 [16][17] - The study aims to evaluate efficacy based on CD47 expression levels [16] Biomarker Development - The company is developing a companion diagnostic to identify patients with high CD47 expression, which is crucial for treatment selection [15][16] - CD47 is recognized as a poor prognostic marker across various cancers, but its predictive use for treatment decision-making is still under development [15] ALX 2004 Development - ALX 2004 is an EGFR-targeting ADC developed in-house, with a focus on optimizing linker payloads and epitope selection to address past challenges in EGFR-targeted therapies [22][23] - The phase 1 trial is being conducted in multiple solid tumors, with initial safety data expected in the first half of 2026 [24][25] Competitive Landscape - The company believes it has a unique asset in ALX 2004, with a distinct epitope and linker payload compared to existing EGFR-targeted ADCs [25][26] - There is competition from various ADCs, particularly from China, but ALX Oncology claims to be first in treating U.S. patients with this specific approach [26] Financial Position and Future Outlook - The company has sufficient cash to support operations through Q1 2027, with several important milestones expected in the next 12 months [27] - Key upcoming events include safety data for ALX 2004 and interim data for the breast cancer study involving evorpacept [27] Additional Important Points - The company is exploring partnerships, particularly in Asia, to expand its market reach for gastric cancer treatments [14] - The strategic shift towards focusing on anti-cancer antibodies for evorpacept combinations reflects a response to clinical learnings over the past decade [5][6]

Summary of ALX Oncology Holdings Conference Call Company Overview - **Company**: ALX Oncology Holdings (NasdaqGS:ALXO) - **Focus**: The company has pivoted to focus on two high-value programs: evorpacept (a differentiated CD47 program) and ALX2004 (a novel EGFR targeted ADC) [4][5] Core Points and Arguments CD47 Program - **Mechanism**: Evorpacept provides full blockade of CD47, which is crucial for immune system communication. It combines with the Fc activity of antibodies to enhance macrophage activity [7][8] - **Clinical Data**: Strong results observed in gastric cancer patients with confirmed HER2 positivity, indicating a transformational benefit for patients with both HER2 positivity and high CD47 expression [8][12] - **Future Focus**: The company aims to validate the CD47 biomarker across various datasets, particularly in HER2-positive cancers [13][15] ALX2004 Program - **ADC Development**: ALX2004 is an EGFR targeted ADC with a unique linker payload and epitope designed to minimize on-target skin toxicity, a common issue with existing EGFR therapies [44][46] - **Clinical Progress**: The first patient was dosed in August, and the program is currently in the clinic with a focus on safety and early efficacy signals [43][55] Safety and Efficacy - **Safety Profile**: The dead Fc design of evorpacept has shown a favorable safety profile, allowing exploration in earlier treatment lines, including adjuvant and neoadjuvant settings [35][36] - **Efficacy Expectations**: The company aims for a response rate of 35% or more in double-positive patients in ongoing studies, which would validate their approach [24][31] Financial Outlook - **Cash Runway**: The company has a cash runway extending into early Q1 2027, focusing on the two clinical trials as priority [59] Other Important Content - **Regulatory Interactions**: The company has had discussions with the FDA regarding study design and is preparing for potential pivotal studies based on interim data [29][31] - **Market Positioning**: ALX Oncology is positioning itself in a competitive ADC landscape by leveraging unique scientific insights and a strong safety profile to differentiate its products [42][48] This summary encapsulates the key points discussed during the conference call, highlighting the strategic focus, clinical advancements, and financial positioning of ALX Oncology.

Core Insights - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment and improving patient survival [1][3] - The company will participate in two significant healthcare conferences: the Jefferies Global Healthcare Conference in London and the Piper Sandler 37th Annual Global Healthcare Conference in New York [1][2] Conference Details - Jefferies Global Healthcare Conference: - Format: Fireside Chat - Date: November 19, 2025 - Time: 11:30 AM GMT / 6:30 AM EST - Location: London, UK [2] - Piper Sandler 37th Annual Global Healthcare Conference: - Format: Fireside Chat - Date: December 3, 2025 - Time: 9:30 AM EST - Location: New York, NY [2] Company Pipeline - ALX Oncology's lead candidate, evorpacept, is positioned as a potential cornerstone therapy in immuno-oncology and is undergoing multiple clinical trials across various cancer indications [3] - The second candidate, ALX2004, is an EGFR-targeted antibody-drug conjugate that began Phase 1 trials in August 2025 [3]

Core Insights - ALX Oncology Holdings Inc. is a clinical-stage biotechnology company focused on developing novel cancer therapies aimed at extending patients' lives [3] - The company will participate in two significant healthcare conferences: the Jefferies Global Healthcare Conference in London and the Piper Sandler 37 Annual Global Healthcare Conference in New York [1][2] Conference Details - Jefferies Global Healthcare Conference: - Format: Fireside Chat - Date: November 19, 2025 - Time: 11:30 AM GMT / 6:30 AM EST - Location: London, UK [2] - Piper Sandler 37 Annual Global Healthcare Conference: - Format: Fireside Chat - Date: December 3, 2025 - Time: 9:30 AM EST - Location: New York, NY [2] Company Pipeline - ALX Oncology's lead candidate, evorpacept, is being evaluated in multiple clinical trials across various cancer indications and is positioned as a cornerstone therapy for future immuno-oncology developments [3] - The second candidate, ALX2004, is an EGFR-targeted antibody-drug conjugate that began Phase 1 trials in August 2025 [3]

Group 1 - The article does not provide any relevant content regarding company or industry insights [1]

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]