Financial Performance - The company incurred net losses of $160.8 million, $134.9 million, and $101.7 million for the years ended December 31, 2023, 2024, and 2025, respectively, with an accumulated deficit of $722.8 million as of December 31, 2025[197]. - The company has not generated any revenue from product sales, licenses, or collaborations to date and does not expect to do so for the foreseeable future[206]. - As of December 31, 2025, the company had cash, cash equivalents, and investments of $48.3 million, which, along with $140.3 million raised in a registered offering, is expected to fund operations through the first half of 2028[200]. - The company will require substantial additional capital to finance its operations and may need to raise funds through public or private equity offerings, which could dilute existing stockholders[203]. - The company expects to continue incurring significant expenses and increasing operating losses for the foreseeable future, which may adversely affect its working capital and ability to achieve profitability[198]. Product Development and Clinical Trials - The company is highly dependent on the success of its lead product candidate, evorpacept, which is still in clinical development and has not completed pivotal trials[196]. - The company has no products approved for commercial sale and has a limited operating history, making it difficult to evaluate its business and prospects[205]. - Clinical trials for product candidates are expensive and time-consuming, with the potential for significant delays or failures in demonstrating safety and efficacy[219]. - In April 2025, topline data from Phase 2 ASPEN-03 and ASPEN-04 clinical trials did not meet primary endpoints, leading to the decision to discontinue pursuing evorpacept in combination with pembrolizumab for head and neck squamous cell carcinoma[216]. - The company may face challenges in enrolling sufficient subjects for clinical trials, particularly for indications with small patient populations, which could delay regulatory submissions[225]. Regulatory and Compliance Risks - The company must navigate various risks related to clinical trial execution, including compliance with protocols and potential adverse effects of product candidates[223]. - Regulatory authorities may require additional data or modifications to clinical trial designs, potentially delaying timelines for marketing approvals[217]. - The company is subject to customary affirmative and negative covenants under its Loan Agreement, which could impact its operational flexibility[212]. - The FDA's regulatory processes are lengthy and unpredictable, potentially delaying the commercialization of product candidates and impacting revenue generation[278]. - The company has received FDA Fast Track designation for evorpacept, but this does not guarantee faster approval or marketing authorization[283]. Competition and Market Challenges - The company faces substantial competition from major pharmaceutical and biotechnology companies in the immuno-oncology therapy market, which may impact the development and commercialization of evorpacept and ALX2004[2]. - Competitors are developing drugs targeting the CD47 pathway and antibody-drug conjugates (ADCs) targeting EGFR, which could affect the company's market position[4]. - If evorpacept and ALX2004 are approved, they are expected to be priced at a significant premium over competitive generic products, potentially hindering the company's business strategy[5]. - Market acceptance of product candidates like evorpacept and ALX2004 is uncertain and depends on various factors, including competition and side effects[258]. Intellectual Property and Patent Risks - The company faces risks related to patent protection, as its patent portfolio is relatively small compared to larger pharmaceutical companies[324]. - The patent protection process is expensive and time-consuming, and the company may not be able to maintain or enforce all necessary patents[324]. - The company may face challenges in enforcing its intellectual property rights in foreign jurisdictions, where legal protections may be weaker[330]. - The company’s patents could be challenged or invalidated, impacting its proprietary technology and product candidates[339]. - There is a risk that patents may be invalidated or limited, allowing competitors to develop similar products, which could harm the company's competitive position[349]. Operational and Management Challenges - The company currently has 43 employees, with 29 engaged in research and development, and anticipates needing additional personnel to support future growth[369]. - The company faces intense competition for qualified personnel in the San Francisco Bay Area, which may increase recruitment costs and impact its ability to retain talent[375]. - The company relies on independent organizations for clinical management and manufacturing, and any disruptions could delay clinical trials and marketing approvals[370]. - The company has limited financial and managerial resources, which may lead to missed opportunities in pursuing more profitable product candidates[387]. Legal and Compliance Issues - Compliance with healthcare fraud and abuse laws is critical, as violations could result in substantial penalties and impact business operations[301]. - Noncompliance with healthcare laws could result in significant fines, penalties, and enforcement actions that may adversely affect the company's business[305]. - The company is subject to numerous environmental, health, and safety laws, which could lead to substantial costs for compliance and potential fines for violations[306]. - The company must comply with the Foreign Corrupt Practices Act and similar laws, which could result in severe penalties for violations, including fines and loss of export privileges[309]. International Expansion and Risks - The company is exposed to various international business risks, including regulatory, political, and financial challenges associated with operations outside the United States[377]. - The company plans to expand internationally, which may involve hiring sales representatives and conducting outreach activities in new markets[377]. - International markets may impose price controls and reimbursement challenges that could hinder the commercialization of future product candidates[297][298].

Group 1 - UBS initiated coverage of ALX Oncology (ALXO) with a Buy rating and a price target of $6 [1] - The company has a potential blockbuster program involving a CD47 combination therapy currently in Phase II for metastatic breast cancer [1] - UBS anticipates ALX reporting a "robust" dataset in mid-2027, showcasing the efficacy of the CD47 inhibitor evorpacept in CD47 high and/or HER2+ metastatic breast cancer patients [1]

Summary of ALX Oncology FY Conference Call (March 03, 2026) Company Overview - **Company**: ALX Oncology (NasdaqGS:ALXO) - **Key Personnel**: Jason Lettmann (CEO), Dr. Barbara Klencke (Chief Medical Officer) - **Focus**: Advancing two novel oncology treatments: evorpacept (EVO) and ALX2004 [2][3] Core Programs Evorpacept (EVO) - **Type**: Novel CD47-targeting therapy - **Development**: In development since 2015, focusing on how cancer evades immune detection via CD47 [2][3] - **Clinical Focus**: - Currently targeting breast cancer, particularly post-HER2 treatment patients [4][5] - ASPEN breast study aims to enroll 80 patients, with top-line data expected in mid-2027 [4][20] - **Clinical Data**: - ASPEN-06 study showed a 65% response rate in HER2-positive patients compared to 26% in the control arm, indicating a 40% delta [10][11] - Combination studies with other therapies (e.g., Herceptin, zanidatamab) have shown promising results [6][10] - **Safety Profile**: No significant on-target toxicities reported, differentiating from conventional CD47 therapies [8][17] ALX2004 - **Type**: EGFR-targeted antibody-drug conjugate (ADC) - **Development**: Focused on minimizing skin toxicity and maximizing therapeutic window [21][22] - **Clinical Trials**: - Ongoing dose escalation studies, with safety data expected in the second half of 2026 [27] - Targeting EGFR overexpressing tumors, including lung, head and neck, colorectal, and esophageal cancers [27] - **Unique Features**: - Utilizes a proprietary linker and TOPO1 payload, aiming for improved efficacy and safety [22][23] Financials - **Recent Financing**: Closed a financing round of $150 million, funding operations through the first half of 2028 [5][30] - **Market Opportunity**: Approximately 20,000 addressable patients in the HER2-positive and CD47 overexpressing population [20] Strategic Outlook - **Execution Focus**: Emphasis on executing clinical studies and achieving pivotal readiness for both programs by the end of 2027 [28][30] - **Partnership Opportunities**: Open to collaborations, with a successful history of partnerships (e.g., with Sanofi) [32][33] - **Market Positioning**: Positioned to address significant unmet needs in oncology, particularly in breast cancer and EGFR-related tumors [28][29] Additional Insights - **Clinical Validation**: The unique mechanism of action of EVO, using a dead Fc to avoid on-target toxicity, has been validated across multiple studies [6][8] - **Response Rates**: High response rates in various cancer settings indicate the potential of both EVO and ALX2004 to change treatment paradigms [10][12][13] - **Future Data**: Upcoming data presentations at major conferences (e.g., ESMO Breast Cancer 2026) are anticipated to further validate the efficacy of these treatments [19][20]

Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $22.8 million for Q4 2025, or $0.42 per basic undiluted share, compared to a net loss of $29.2 million for Q4 2024, or $0.55 per basic and diluted share, indicating a decrease in year-over-year spending primarily due to lower stock compensation and personnel costs [26][24]. Business Line Data and Key Metrics Changes - The clinical development of Evorpacept (EVO) has shown significant progress, with over 750 patients treated, demonstrating its potential across various combinations and tumor types [4][5]. - ALX2004, the company's novel EGFR-targeted ADC, has cleared the first two dose cohorts and is currently in a phase I trial with the 4 mg/kg dose [8][19]. Market Data and Key Metrics Changes - The company anticipates that approximately half of the patients in the ASPEN-09-Breast study will be CD47 high, based on previous studies indicating a consistent percentage across different tumor types [48][49]. Company Strategy and Development Direction - The company aims to advance both Evorpacept and ALX2004 to a stage ready for pivotal studies by the end of next year, focusing on execution and robust data readouts over the next 12-18 months [4][9]. - A CD47 biomarker-driven approach is being developed to enable targeted patient selection, with plans for a companion diagnostic for CD47 expression [18][19]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential of Evorpacept to provide substantial benefits in metastatic breast cancer patients, particularly in the post-ENHERTU setting [18][19]. - The company is optimistic about the strong investigator interest in the ASPEN-09 study and expects to share meaningful efficacy and safety data by mid-2027 [19][36]. Other Important Information - The company completed a financing round of $150 million, strengthening its balance sheet and providing sufficient funds to cover operating expenses through the first half of 2028 [24][25]. - The full biomarker analysis from the phase 1/2 trial evaluating Evorpacept in combination with panitumumab is expected to be presented at the ESMO Breast Cancer Conference in May 2026 [25]. Q&A Session Summary Question: Update on ASPEN-09-Breast study and rationale for upsizing to 120 patients - Management confirmed that the study will focus on 80 patients for full data readout in mid-next year, with the upsizing to 120 patients aimed at ensuring robust data across various subpopulations [30][31][33]. Question: Feedback from investigators on the biomarker approach - Investigators are excited about the biomarker selection strategy, which aims to identify a patient population that will benefit significantly from the therapy [35][36]. Question: Reasons for pushing out safety data for ALX2004 - The change in timeline is to ensure robust data communication, with a focus on providing meaningful updates towards the end of the year [39][40]. Question: Expected ratio of CD47 high versus low expression in ASPEN-09 - Management expects around half of the patients to be CD47 high, based on literature and previous studies [48][49]. Question: Monitoring for interstitial lung disease and skin toxicity in ALX2004 - Patients will undergo regular CT scans to monitor for ILD and skin toxicity, with a low likelihood of severe toxicity based on non-human primate studies [58][59].

Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $22.8 million for Q4 2025, or $0.42 per basic undiluted share, compared to a net loss of $29.2 million for Q4 2024, or $0.55 per basic and diluted share, indicating a decrease in year-over-year spending primarily due to lower stock compensation and personnel costs [27][25][26] - Cash equivalents and investments totaled $48.3 million before a recent equity financing that raised $140.4 million, providing sufficient funds to cover operating expenses through the first half of 2028 [25][26] Business Line Data and Key Metrics Changes - The company has made significant progress on its lead program, Evorpacept, and its first antibody-drug conjugate (ADC), ALX2004, with both programs expected to reach pivotal study readiness by the end of next year [4][10] - Evorpacept has treated over 750 patients, demonstrating its potential across various combinations and tumor types, particularly in HER2-positive gastric cancer, where a response rate of 65% was observed compared to 26% in the control arm [5][11] Market Data and Key Metrics Changes - The company is focusing on the unmet need in the post-ENHERTU treatment landscape for HER2-positive patients, with expectations that about half of the population will exhibit high CD47 expression [50][56] - The ongoing phase II trial for Evorpacept is being expanded to 120 patients to ensure robust data across various subpopulations, particularly those with CD47 overexpression [34][66] Company Strategy and Development Direction - The company aims to advance both Evorpacept and ALX2004 to pivotal study readiness by the end of next year, with a focus on execution and delivering meaningful data readouts [4][10] - A companion diagnostic for CD47 expression is being developed to enable targeted patient selection for future studies, enhancing the regulatory strategy [19][66] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential of Evorpacept to provide substantial benefits in metastatic breast cancer patients, particularly in the context of CD47 expression [19][50] - The company is optimistic about the upcoming data readouts and the strategic prioritization of its clinical programs, which are expected to yield significant catalysts over the next 12-18 months [10][29] Other Important Information - The company has cleared the first two dose cohorts for ALX2004 and is currently in the phase I trial, with safety data expected in the second half of 2026 [9][20] - The clinical spend will be primarily driven by the ongoing trials for Evorpacept and ALX2004, with reduced spending in legacy trials [27][28] Q&A Session Summary Question: Update on ASPEN-09-Breast study and rationale for upsizing to 120 patients - Management confirmed the guidance towards an 80-patient readout in mid-next year, emphasizing the need for robust data across CD47-positive patients [31][32] Question: Feedback from investigators on the biomarker approach - Investigators are excited about the biomarker selection strategy, which aims to identify patients who will benefit most from the therapy [36][37] Question: Reasons for pushing out safety data for ALX2004 - The change was made to ensure that the data communicated is robust and meaningful, with a focus on providing comprehensive updates [40][41] Question: Expected ratio of CD47 high versus low expression in ASPEN-09 - Management anticipates that about half of the patients will exhibit high CD47 expression, based on previous studies [49][50] Question: Monitoring for interstitial lung disease and skin toxicity in ALX2004 - Patients will undergo regular CT scans to monitor for interstitial lung disease, and skin toxicity is expected to be minimal based on preclinical data [58][59]

Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $22.8 million for Q4 2025, compared to a loss of $29.2 million in Q4 2024, indicating a year-over-year improvement in financial performance [28] - Cash equivalents and investments totaled $48.3 million at the end of Q4 2025, bolstered by a recent equity financing that raised $140.4 million in net proceeds [26][28] Business Line Data and Key Metrics Changes - The clinical development of Evorpacept (EVO) has shown significant progress, with over 750 patients treated and promising data from various tumor types [5][6] - ALX2004, the company's novel EGFR-targeted antibody-drug conjugate, is currently in a Phase I trial, with safety data expected in the second half of 2026 [10][21] Market Data and Key Metrics Changes - The company is focusing on the HER2-positive breast cancer market, with a notable response rate of 65% in gastric cancer patients treated with Evorpacept compared to 26% in the control group [12] - In the indolent non-Hodgkin's lymphoma setting, Evorpacept combined with RITUXAN and REVLIMID achieved a complete response rate of 92%, significantly higher than benchmark studies [17] Company Strategy and Development Direction - The company aims to advance both Evorpacept and ALX2004 to pivotal study readiness by the end of 2026, focusing on execution and robust data generation [5][11] - A CD47 biomarker-driven approach is being pursued to enhance patient selection for therapies, particularly in HER2-positive patients [20][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential of Evorpacept to provide substantial benefits in metastatic breast cancer settings [20][36] - The company acknowledges a significant unmet need for effective treatment options in the post-ENHERTU setting, indicating a strategic focus on addressing this gap [19][56] Other Important Information - The company has initiated work on developing a companion diagnostic for CD47 expression to support future registration studies [20] - The recent financing has strengthened the company's balance sheet, allowing for more robust data readouts in ongoing clinical programs [26][27] Q&A Session Summary Question: Update on ASPEN-09-Breast study and rationale for upsizing to 120 patients - Management confirmed the focus on 80 patients for full data readout in mid-next year, emphasizing the need for robust data across various patient segments [32][33] Question: Feedback from investigators on the biomarker approach - Investigators are excited about the biomarker selection strategy, which aims to identify patients who will benefit most from the therapy [36][37] Question: Safety data for ALX2004 and monitoring for interstitial lung disease - Safety data is expected in the second half of 2026, with regular CT scans to monitor for potential interstitial lung disease and skin toxicity [41][58] Question: Expected ratio of CD47 high versus low expression in ASPEN-09 - Approximately half of the population is expected to be CD47 high, based on previous studies [49] Question: Concerns about subsequent ADC use impacting CD47 expression - Literature suggests CD47 expression may rise post-ENHERTU, which aligns with the target patient population [56]

Corporate Overview February 2026 NASDAQ GS ALXO © ALX Oncology Inc. All rights reserved. This presentation shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall thereby any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. 2 Confidential Forward-looking Statements Certain information set forth i ...

Financial Performance - ALX Oncology reported a GAAP net loss of $22.8 million for Q4 2025, or $0.42 per share, compared to a net loss of $29.2 million, or $0.55 per share, in Q4 2024[12]. - For the full year 2025, the GAAP net loss was $101.7 million, or $1.90 per share, down from a loss of $134.9 million, or $2.58 per share, in 2024[12]. - The net loss for the three months ended December 31, 2025, was $22,848,000, compared to a net loss of $29,163,000 for the same period in 2024, representing a reduction of 21.5%[17]. - Non-GAAP net loss for the year ended December 31, 2025, was $88,836,000, compared to $107,492,000 in 2024, showing an improvement of 17.3%[20]. - The company reported a basic and diluted net loss per share of $0.42 for the three months ended December 31, 2025, compared to $0.55 for the same period in 2024[17]. Research and Development - Research and Development (R&D) expenses for Q4 2025 were $17.6 million, a decrease of $5.9 million from $23.5 million in Q4 2024, primarily due to reduced stock-based compensation and personnel costs[11]. - Research and development expenses for the year ended December 31, 2025, were $76,996,000, down from $116,373,000 in 2024, indicating a decrease of 33.8%[17]. - The Phase 2 ASPEN-09 trial is set to expand enrollment from 80 to up to 120 patients to better assess CD47 overexpression, with topline data expected in mid-2027[7]. - ALX2004's Phase 1 trial is currently enrolling patients in the third dose cohort, with safety data anticipated in the second half of 2026[10]. - 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[4]. - The median duration of response (mDOR) for evorpacept plus TRP was 25.5 months, significantly longer than the 8.4 months for TRP alone[4]. Financial Position - The company held $48.3 million in cash and equivalents as of December 31, 2025, which, combined with new financing, is expected to fund operations through mid-2028[11]. - As of December 31, 2025, ALX Oncology had cash, cash equivalents, and investments totaling $48,284,000, a significant decrease from $131,281,000 as of December 31, 2024[18]. - The accumulated deficit increased to $722,817,000 as of December 31, 2025, compared to $621,122,000 at the end of 2024, reflecting a rise of 16.3%[18]. - Total stockholders' equity decreased to $25,981,000 as of December 31, 2025, from $113,618,000 in 2024, a decline of 77.2%[18]. - Interest income for the year ended December 31, 2025, was $3,964,000, down from $9,366,000 in 2024, a decrease of 57.6%[17]. - Total liabilities remained relatively stable at $33,065,000 as of December 31, 2025, compared to $34,157,000 in 2024, a slight decrease of 3.2%[18]. Management Changes - ALX Oncology appointed Barbara Klencke, M.D., as Chief Medical Officer on a permanent basis, following her interim role since September 2025[1]. Operating Expenses - For the three months ended December 31, 2025, ALX Oncology reported total operating expenses of $23,021,000, a decrease of 24.8% compared to $30,613,000 for the same period in 2024[17].

Core Insights - ALX Oncology is advancing its clinical development for evorpacept and ALX2004, expecting significant data and milestones in the next 12 to 18 months [1][2][3] Evorpacept Developments - Evorpacept's biomarker strategy has been validated, indicating that CD47 overexpression predicts its activity and benefits in HER2-positive cancers [1][4] - The Phase 2 ASPEN-09 trial is currently enrolling patients to evaluate evorpacept's efficacy based on CD47 expression levels, with topline data expected by mid-2027 [1][6] - A combination of evorpacept with trastuzumab and chemotherapy achieved a 65% objective response rate in patients with retained HER2-positive gastric cancer, significantly outperforming the control [6][4] ALX2004 Progress - The Phase 1 trial for ALX2004 is ongoing, with safety data from the dose-escalation phase anticipated in the second half of 2026 [1][3] - ALX2004 has shown promising preclinical anti-tumor activity in various EGFR-expressing tumor models, with a favorable safety profile [7][1] Financial Update - The company completed a $150 million equity offering, extending its cash runway through the first half of 2028 [1][12] - Research and development expenses decreased to $17.6 million for Q4 2025, down from $23.5 million in Q4 2024, reflecting a strategic prioritization of pipeline projects [13][18] - The net loss for Q4 2025 was $22.8 million, an improvement from $29.2 million in Q4 2024, attributed to reduced R&D expenses [18][19] Corporate Changes - Barbara Klencke, M.D., has been appointed as Chief Medical Officer on a permanent basis, having served in an interim capacity since September 2025 [1][12]

Company Overview - Teva Pharmaceutical Industries Ltd. is part of the Medical sector, which includes 925 companies and is currently ranked 8 in the Zacks Sector Rank [2] - Teva has a Zacks Rank of 2 (Buy), indicating a favorable outlook based on earnings estimates and revisions [3] Performance Metrics - Over the past three months, the Zacks Consensus Estimate for Teva's full-year earnings has increased by 1.1%, reflecting improved analyst sentiment [4] - Teva has returned approximately 8.7% since the beginning of the year, outperforming the average gain of 2% in the Medical group [4] - In the Medical - Generic Drugs industry, which consists of 11 stocks, Teva is performing better with year-to-date returns compared to the industry average gain of 2.7% [6] Industry Context - The Medical - Biomedical and Genetics industry, to which ALX Oncology Holdings Inc. belongs, has seen a performance increase of 9.5% this year [7] - Teva and ALX Oncology Holdings Inc. are highlighted as strong performers within their respective industries, suggesting continued investor interest in these stocks [7]