ALX2004 Potential First- and Best-In-Class EGFR-targeted ADC May 2025 NASDAQ GS ALXO © ALX Oncology Inc. All rights reserved. Forward-Looking Statements 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 o ...

Summary of ALX Oncology Holdings (ALXO) Conference Call Company Overview - **Company**: ALX Oncology Holdings (ALXO) - **Focus**: Development of ALX2004, a differentiated antibody-drug conjugate (ADC) targeting EGFR Key Points and Arguments Industry and Product Development - **ADC Focus**: ALX2004 is designed to maximize therapeutic window and overcome historical toxicity challenges associated with EGFR-targeted ADCs [5][6][10] - **Clinical Pipeline**: The company is advancing its ADC in combination with anti-cancer antibodies, specifically targeting breast and colorectal cancers [4][5] - **IND Clearance**: ALX2004 has received Investigational New Drug (IND) clearance, with plans to launch a Phase I trial in mid-2025 [5][7] Scientific Rationale - **Payload and Linker Design**: ALX2004 utilizes a proprietary topoisomerase one inhibitor payload, designed to minimize off-target toxicity while maximizing tumor cell killing [17][20] - **Immunogenic Cell Death**: The payload triggers immunogenic cell death, potentially enhancing long-term tumor control through adaptive immune response [18][28] - **Optimized Antibody**: The antibody component is designed to block EGFR signaling and bind to a unique epitope, potentially overcoming resistance to existing therapies [30][32] Clinical Development Plans - **Phase I Study**: The study will focus on four tumor types: head and neck squamous cell carcinoma, colorectal cancer, non-small cell lung cancer, and esophageal squamous cell carcinoma, targeting patients with relapsed or refractory disease [40][41] - **Safety and Efficacy Goals**: Initial safety data is expected in the first half of 2026, with an emphasis on establishing a recommended dosing schema [42][43] Competitive Landscape - **Market Positioning**: ALX Oncology aims to be a leader in the ADC space targeting EGFR, which currently lacks an approved drug [43][85] - **Comparison with Competitors**: The company is aware of other ADCs in development, such as MRG003, but believes its optimized design gives it a competitive edge [85] Additional Important Insights - **Preclinical Data**: Robust preclinical data supports the efficacy and safety profile of ALX2004, with encouraging results in various tumor models [14][34] - **Toxicity Management**: The design aims to avoid common toxicities seen in previous EGFR-targeted ADCs, such as skin toxicity and interstitial lung disease [14][72] - **Funding and Capital Allocation**: The company has sufficient cash to fund its ongoing studies into 2024, with plans to explore additional capital options as needed [51][52] This summary encapsulates the critical aspects of ALX Oncology's conference call, highlighting the company's strategic focus on developing ALX2004 and its potential impact on the oncology market.

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39386 ALX ONCOLOGY HOLDINGS INC. (Exact name of Registrant as specified in its Charter) (State or other jurisdiction of incorpor ...

Following announcement of prioritized development strategy for evorpacept in combination with anti-cancer antibodies at R&D Day in March, Company is on track to initiate Phase 2 ASPEN-Breast and Phase 1 ASPEN-CRC studies in mid-2025 IND clearance received from U.S. FDA for novel EGFR-targeted antibody-drug conjugate (ADC), ALX2004, paving way for mid-year clinical program initiation; Company to host webcast focused on ALX2004 research program on May 20Company will not pursue U.S. registrational path in gast ...

Core Insights - The combination of ALX Oncology's evorpacept with rituximab and lenalidomide (R2) shows promising anti-tumor activity and was well-tolerated in patients with indolent relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) [1][2][4] - The trial reported a complete response (CR) rate of 83% in patients with indolent NHL, significantly higher than the historical CR rate of 34% for R2 alone [1][3] - The ongoing Phase 2 trial in previously untreated indolent NHL has completed enrollment, indicating continued evaluation of evorpacept's efficacy [1][4] Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment, with evorpacept as its lead candidate [7] - The company aims to address unmet needs in cancer treatment by enhancing the effectiveness of existing therapies [4][7] Clinical Trial Details - The Phase 1/2 trial included 20 patients, with 18 having indolent and 2 having aggressive R/R B-NHL, all of whom had previously received anti-CD20 monoclonal antibodies [2] - The trial demonstrated a two-year progression-free survival (PFS) rate of 69% and an overall survival (OS) rate of 84% after a median follow-up of 28 months [3] - The trial's results will be presented at the AACR 2025 Annual Meeting, highlighting the significance of evorpacept in cancer therapy [5][6]

- Data to be presented at AACR 2025 Annual Meeting suggest the combination of ALX Oncology’s investigational CD47-blocker, evorpacept, plus rituximab and lenalidomide (R2) was well-tolerated and demonstrated promising anti-tumor activity - Combination generated complete responses (CR) in 83% of patients with indolent relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) comparing favorably to 34% historical CR rate with R2 alone - Phase 2 portion of trial in patients with previously untreated indolent ...

Core Insights - ALX Oncology announced topline data from Phase 2 ASPEN-03 and ASPEN-04 clinical trials, revealing that the investigational CD47-blocker evorpacept did not meet primary endpoints for improved objective response rates when combined with Merck's KEYTRUDA® in advanced head and neck squamous cell carcinoma [1][6] - Despite the trial outcomes, the company remains committed to advancing evorpacept in combination with other anti-cancer antibodies based on previous positive clinical data [4][6] Group 1: Clinical Trial Results - The ASPEN-03 and ASPEN-04 trials evaluated evorpacept combined with KEYTRUDA® with or without chemotherapy in patients with advanced head and neck squamous cell carcinoma [7] - The primary endpoints for both trials were objective response rates compared to historical controls, with key secondary endpoints including safety, duration of response, progression-free survival, and overall survival [7] - The combination demonstrated a manageable safety profile consistent with previous reports for pembrolizumab and chemotherapy [1][4] Group 2: Mechanism of Action - Evorpacept functions by blocking the 'don't eat me' signal from CD47 on cancer cells, allowing macrophages to target cancer cells selectively [2][9] - The drug is designed to enhance T-cell priming and stimulate the adaptive immune system, although the trials did not support advancing this combination into registrational studies [3][6] Group 3: Future Directions - The company will continue to explore evorpacept in combination with various anti-cancer antibodies in other cancer types, including colorectal cancer, breast cancer, non-Hodgkin lymphoma, and multiple myeloma [2][4] - ALX Oncology is prioritizing its established anti-cancer antibody combination program, which has shown positive results in other studies [4][6] - Evorpacept has received Fast Track designation from the FDA for second-line treatment of HER2-positive gastric or GEJ carcinoma, indicating its potential in the oncology pipeline [9][10]

Core Viewpoint - ALX Oncology has received FDA clearance for its Investigational New Drug (IND) application for ALX2004, a potential first-in-class antibody-drug conjugate (ADC) targeting EGFR-expressing solid tumors, with plans to initiate a Phase 1 clinical trial in mid-2025 [1][7]. Group 1: Product Development - ALX2004 is designed to optimize the delivery of a chemotherapy payload to tumor cells while minimizing systemic toxicity, demonstrating potent anti-tumor activity in preclinical models [2][3]. - The ADC was developed using the company's proprietary linker-payload platform, which includes a topoisomerase I inhibitor payload that enhances anti-tumor activity [3][7]. - Initial safety data from the Phase 1 clinical trial of ALX2004 is expected to be available in the first half of 2026 [7]. Group 2: Market Context - EGFR is a clinically validated therapeutic target, with overexpression found in various tumor types such as breast cancer and non-small cell lung cancer; however, there are currently no approved EGFR-targeted ADCs [2][3]. - Previous attempts to develop EGFR-targeted ADCs faced challenges due to drug design and toxicity issues, which ALX2004 aims to overcome [2][3]. Group 3: Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on advancing therapies that enhance the immune system to treat cancer [5]. - The company's lead therapeutic candidate, evorpacept, is being evaluated in multiple ongoing clinical trials across various cancer indications [5].

Core Viewpoint - ALX Oncology Holdings Inc. (ALXO) has experienced a bearish trend, losing 19.6% over the past week, but the formation of a hammer chart pattern suggests a potential trend reversal as buying interest may be increasing [1][2]. Technical Analysis - The hammer chart pattern indicates a possible bottoming out, with reduced selling pressure, suggesting that bulls may be gaining control [2][4]. - A hammer pattern forms when there is a small candle body with a long lower wick, typically occurring during a downtrend, signaling a potential reversal if it appears at the bottom of the trend [3][4]. Fundamental Analysis - There has been a notable upward trend in earnings estimate revisions for ALXO, with a 28.5% increase in the consensus EPS estimate over the last 30 days, indicating analysts expect better earnings than previously predicted [6][7]. - ALXO holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which historically outperforms the market [8].

Financial Performance - The company incurred net losses of $134.9 million, $160.8 million, and $123.5 million for the years ended December 31, 2024, 2023, and 2022, respectively, with an accumulated deficit of $621.1 million as of December 31, 2024[142]. - As of December 31, 2024, the company had cash, cash equivalents, and investments of $131.3 million, which are expected to fund operations into the fourth quarter of 2026[145]. - The company will require substantial additional capital to finance its operations and may need to raise funds through public or private equity offerings, debt financings, or collaborations[144]. - As of December 31, 2024, the company had net operating loss carryforwards of approximately $162.6 million for U.S. federal income tax purposes and $69.0 million for state income tax purposes, with federal losses carrying forward indefinitely but limited to offsetting 80% of future taxable income[315]. - The company also reported Irish net operating loss carryforwards of approximately $5.5 million, which do not expire but may not be fully utilized without sufficient income generation in Ireland[316]. Product Development and Regulatory Challenges - The company has no products approved for commercial sale and has not generated any revenue from product sales, licenses, or collaborations to date[142]. - The company has a limited operating history and has not yet demonstrated the ability to successfully complete large-scale clinical trials or obtain marketing approvals[149]. - The company's ability to generate revenue and achieve profitability depends significantly on the successful development and commercialization of its product candidates[150]. - The company is heavily dependent on the success of its lead product candidate, evorpacept, which is currently in clinical development and has not completed a pivotal trial[158]. - The company has not received regulatory approval for any products and may never be able to develop marketable product candidates[158]. - Clinical trials are expensive and time-consuming, with the potential for significant delays due to various factors, including recruitment challenges and regulatory requirements[161][165]. - The company must demonstrate substantial evidence of safety and efficacy through well-controlled clinical trials before seeking regulatory approvals[161]. - The company may incur unplanned costs and face challenges in obtaining favorable coverage and reimbursement from third-party payors for its product candidates[158]. - The company is focused on obtaining, maintaining, and expanding patent protection and regulatory exclusivity for its product candidates[158]. - The company may need to conduct additional clinical trials that could be costly and time-consuming to meet regulatory requirements[205]. - The FDA's approval process is lengthy and unpredictable, potentially delaying revenue generation from product candidates[217]. Competition and Market Dynamics - The company faces substantial competition from major pharmaceutical and biotechnology companies, including AstraZeneca, Bristol Myers Squibb, and Merck, which may impact the development and commercialization of evorpacept[171]. - Competitors are developing drugs targeting the CD47 pathway, which may affect the market potential of the company's product candidates[172]. - If approved, evorpacept is expected to be priced at a significant premium over competitive generic products, potentially complicating the company's business strategy[173]. - The company's market opportunities may be limited to smaller patient subsets, which could adversely affect its business if regulatory authorities require narrower indications[205]. Operational Risks and Challenges - The company may face challenges in attracting and retaining qualified personnel, which could impact its ability to implement its business strategy[142]. - The company relies on third-party manufacturers for the production of its product candidates, which increases the risk of supply delays and quality issues[184]. - The company previously relied on Tallac Therapeutics for preclinical research activities, and any disruptions in transitioning these activities in-house could delay the development pipeline[179]. - The company faces challenges in maintaining and expanding its organization, which could hinder the development and commercialization of evorpacept and other product candidates[294]. - The company is highly dependent on key personnel, and the loss of any executive officers or key employees could result in delays in product development[296]. Legal and Compliance Issues - The company is subject to various healthcare laws and regulations, including the Civil Monetary Penalty Act and HIPAA, which impose significant compliance costs and potential penalties for violations[237]. - Non-compliance with healthcare laws could result in civil, criminal, and administrative penalties, including exclusion from government-funded healthcare programs, which may adversely affect the company's operations and financial results[238]. - The company faces risks related to employee fraud and misconduct, which could lead to regulatory sanctions and reputational harm[239]. - Compliance with environmental, health, and safety laws is critical, as violations could result in substantial fines and impair research and development efforts[240]. Intellectual Property and Patent Risks - The company's patent portfolio is relatively small compared to larger competitors, and maintaining patent protection is critical for its strategy[255]. - Changes in patent laws and interpretations may diminish the value of patents, impacting the company's ability to protect its product candidates[265]. - The company may face litigation risks related to patent infringement claims, which could materially harm its business and financial condition[284]. - The company is aware of third-party patents in the immuno-oncology field that may cover its product candidates, including U.S. patent 10,907,209 and U.S. patent application 16/118,038, which could limit its ability to pursue evorpacept in certain indications and geographies[282]. Financial and Market Conditions - The company may experience significant volatility in its stock price, influenced by factors such as clinical trial results and market conditions for biotechnology stocks[320]. - Future sales of a substantial number of shares in the public market could lead to a significant decline in the company's stock price[330]. - The company incurred significant legal, accounting, and compliance costs as a public entity, impacting management resources[334]. - The company maintains an ERP system requiring substantial investment, which is crucial for managing operations and tracking performance[335]. Future Outlook and Strategic Considerations - The company may face challenges in attracting and retaining experienced personnel due to high living costs in the San Francisco Bay Area and competition from larger biotechnology firms[298]. - The anticipated benefits of acquisitions or joint ventures may not materialize, potentially harming the company's financial condition[314]. - The company may face difficulties in integrating acquired businesses or assets, which could delay the realization of expected benefits[313].