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ALX Oncology Announces Encouraging Final Results from Phase 1 Trial Evaluating Evorpacept in Combination with Standard-of-Care Treatment in Patients with B-cell Non-Hodgkin Lymphoma
Newsfilter· 2025-04-25 17:10
- 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 ...
ALX Oncology Announces Encouraging Final Results from Phase 1 Trial Evaluating Evorpacept in Combination with Standard-of-Care Treatment in Patients with B-cell Non-Hodgkin Lymphoma
GlobeNewswire· 2025-04-25 17:10
- 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 ...
ALX Oncology Reports ASPEN-03 and ASPEN-04 Phase 2 Trials Evaluating Evorpacept with a Checkpoint Inhibitor for the Treatment of Head and Neck Cancers Did Not Meet Primary Endpoints
Newsfilter· 2025-04-25 13:00
In ASPEN-03 and ASPEN-04 trials, efficacy data do not support advancing evorpacept in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), into a registrational studyCompany remains confident in continuing to pursue evorpacept in multiple clinical trials, based on the different mechanism of evorpacept in combination with anti-cancer antibodies, as evidenced by durable clinical response and consistent safety data in prior clinical trials SOUTH SAN FRANCISCO, April 25, 2025 (GLOBE NEWSWIRE) ...
ALX Oncology Receives IND Clearance from U.S. FDA for ALX2004, a Novel EGFR-targeted Antibody-drug Conjugate
Newsfilter· 2025-04-07 12:00
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].
ALX Oncology Holdings (ALXO) Could Find a Support Soon, Here's Why You Should Buy the Stock Now
ZACKS· 2025-03-20 14:55
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].
ALX Oncology(ALXO) - 2024 Q4 - Annual Report
2025-03-06 21:33
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].
ALX Oncology(ALXO) - 2024 Q4 - Annual Results
2025-03-06 21:01
Exhibit 99.1 ALX Oncology Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update – Presented positive updated data from ASPEN-06 Phase 2 trial demonstrating evorpacept generates strong response and durable clinical benefit in patients with HER2-positive gastric cancer in an oral presentation at 2025 ASCO GI – Presented Phase 1b/2 data demonstrating evorpacept in combination with zanidatamab generates promising anti-tumor activity in advanced breast cancer at SABCS 2024 – A ...
ALX Oncology Highlights Focused Evorpacept Development Plan, Clinical Progress and Corporate Updates at R&D Day Webcast Event
Newsfilter· 2025-03-05 13:00
Core Insights - ALX Oncology is advancing its clinical pipeline, focusing on the CD47-blocker evorpacept and the novel EGFR-directed ADC candidate ALX2004, with key updates provided during an R&D Day webcast event [1][8] Clinical Development Updates - The company is enhancing its evorpacept program, particularly in combination with existing anti-cancer therapies for HER2-positive cancers, with new trials planned for breast and colorectal cancers expected to start in the first half of 2025 [3][4] - ALX2004, a new ADC candidate, is set for an Investigational New Drug (IND) submission to the FDA in Q1 2025, aiming to optimize anti-tumor activity [6][8] Corporate Strategy and Financial Updates - ALX Oncology is implementing strategic prioritization and resource optimization, resulting in a workforce reduction of approximately 30% in preclinical research to extend its cash runway into Q4 2026 [9][8] - The company is focusing resources on high-priority programs to ensure successful execution of ongoing studies and to generate value from its cancer therapies [3][9]
ALX Oncology Highlights Focused Evorpacept Development Plan, Clinical Progress and Corporate Updates at R&D Day Webcast Event
GlobeNewswire· 2025-03-05 13:00
Core Insights - ALX Oncology is advancing its clinical pipeline, focusing on the CD47-blocker evorpacept and the novel EGFR-directed ADC candidate ALX2004, with key updates provided during an R&D Day webcast event [1][8] Clinical Development Updates - The company is optimistic about evorpacept's potential, particularly for HER2-positive cancers, and plans to initiate new clinical trials combining evorpacept with trastuzumab and cetuximab in breast and colorectal cancers in the first half of 2025 [3][4] - Evorpacept is currently being evaluated in ongoing trials, with discussions on regulatory pathways for gastric cancer based on ASPEN-06 data [3][4] New Product Introduction - ALX2004, a new ADC candidate, is designed to enhance anti-tumor activity and is expected to have an IND application submitted to the FDA in Q1 2025 [6][8] Corporate Strategy and Financial Updates - The company is streamlining operations and prioritizing resources, resulting in a workforce reduction of approximately 30% in preclinical research to extend its cash runway into Q4 2026 [3][9] - The strategic prioritization aims to support new clinical trial programs while optimizing existing resources [9]
ALX Oncology to Report Fourth Quarter and Full Year 2024 Financial Results on March 6, 2025
GlobeNewswire· 2025-02-27 13:00
Core Viewpoint - ALX Oncology Holdings Inc. plans to report its fourth quarter and full year 2024 financial results on March 6th, 2025, before market open [1]. Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing therapies that enhance the immune system to treat cancer and improve patient survival [3]. - The company's lead therapeutic candidate, evorpacept, is being evaluated in multiple ongoing clinical trials across various cancer indications, indicating its potential as a cornerstone therapy in immuno-oncology [3].