ALX Oncology(ALXO)
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ALX Oncology Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-11-07 13:15
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]
ALX Oncology to Report Third Quarter 2025 Financial Results and Pipeline Progress Including Evorpacept CD47 Biomarker Data to be Presented at Upcoming SITC Annual Meeting
Globenewswire· 2025-10-30 12:30
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]
ALX Oncology Announces Preclinical Data and Phase 1 Trial-in-Progress Presentations of ALX2004, a Novel EGFR-Targeted ADC, at 2025 AACR-NCI-EORTC Conference
Globenewswire· 2025-10-23 16:30
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]
Is Alnylam Pharmaceuticals (ALNY) Outperforming Other Medical Stocks This Year?
ZACKS· 2025-10-14 14:41
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]
ALX Oncology to Present Updated Data from Phase 2 ASPEN-06 Trial, Highlighting CD47 Expression as a Predictive Biomarker in HER2+ Gastric Cancer, at 40th Society for Immunotherapy of Cancer (SITC) Annual Meeting
Globenewswire· 2025-10-03 13:05
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]
Friday 9/19 Insider Buying Report: AROC, ALXO
Nasdaq· 2025-09-19 15:27
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]
After-Hours Trading Sees Sharp Gains Across Emerging Growth Names
RTTNews· 2025-09-19 04:47
Core Insights - Several small-cap stocks experienced significant gains in after-hours trading, driven by strategic updates, leadership changes, and pipeline developments, indicating renewed investor interest [1] Adaptimmune Therapeutics plc (ADAP) - ADAP's stock surged 30% in after-hours trading, reaching $0.2020 after a 98% gain during the regular session, closing at $0.16 [2] - The company reported a net loss of $30.3 million for Q2 2025, with total revenue of $13.7 million, primarily from product sales of TECELRA, which saw over 150% growth compared to Q1 [3] - In August, Adaptimmune sold several cell therapies to US WorldMeds for $55 million upfront, with potential future milestone payments of up to $30 million, allowing the company to repay its debt and restructure [4] Butterfly Network Inc. (BFLY) - BFLY's stock rose 10.58% in after-hours trading to $2.09, following a 15.95% increase during the regular session [4] - The company was recognized in TIME's list of the World's Top HealthTech Companies for 2025, and appointed a new Chief Technology Officer, enhancing its focus on innovation [5] - A recent study confirmed that Butterfly-enabled POCUS programs significantly reduce hospital stays and costs, validating its clinical impact [5] Aquestive Therapeutics Inc. (AQST) - AQST's stock increased 7.69% in after-hours trading to $5.32, continuing a year-to-date rise of nearly 39% [6] - The FDA confirmed it will not require an advisory committee meeting for AQST's NDA for Anaphylm, streamlining the regulatory process with a PDUFA date set for January 2026 [7] - The company secured a $75 million strategic funding agreement to support the potential launch of Anaphylm, reinforcing its commercial readiness [7] ALX Oncology Holdings Inc. (ALXO) - ALXO's stock rose 9.17% in after-hours trading to $1.19, following a 3.81% increase during the regular session [8] - Insider buying activity, particularly by CEO Jason Lettmann, who purchased 92,233 shares, has boosted investor confidence [9] - The company's lead candidate, Evorpacept, is in multiple Phase 1 and Phase 2 trials across various cancers, collaborating with major partners [9] Ekso Bionics Holdings Inc. (EKSO) - EKSO's stock increased 5.37% in after-hours trading to $4.51, following a 9.74% gain during the regular session [10] - The company's inclusion in the NVIDIA Connect Program has spotlighted its efforts to integrate AI into its technologies [11] - EKSO launched Virtual eksoUniversity to support continuing education for physical therapists, potentially broadening adoption of its rehabilitation devices [11] CEL-SCI Corp. (CVM) - CVM's stock rose 5.27% in after-hours trading to $9.39, after a 1.02% increase during the regular session [12] - The company completed a $10 million public offering to support ongoing clinical and regulatory efforts [13] - CEL-SCI filed for Breakthrough Medicine Designation in Saudi Arabia for its lead candidate, Multikine, which could expedite patient access and reimbursement [13]
ALX Oncology Appoints Board Member Barbara Klencke, M.D., as Interim Chief Medical Officer
Globenewswire· 2025-09-12 12:30
Core Viewpoint - ALX Oncology has appointed Dr. Barbara Klencke as Interim Chief Medical Officer, succeeding Dr. Alan Sandler, who will return to the Board of Directors [1][2][5] Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment, with a pipeline that includes evorpacept and ALX2004 [3] - Evorpacept is positioned as a cornerstone therapy in immuno-oncology and is currently undergoing multiple clinical trials across various cancer indications [3] - ALX2004 is a novel EGFR-targeted antibody-drug conjugate that entered Phase 1 clinical trials in August 2025 [3] Leadership Changes - Dr. Klencke brings over 30 years of experience in oncology and has previously served as CMO at Sierra Oncology, contributing to its acquisition by GlaxoSmithKline [2][5] - The transition aims to enhance the execution of the company's development strategy for its clinical programs [2]
ALX Oncology to Participate in Upcoming Investor Conferences in September
Globenewswire· 2025-08-29 16:00
Core Insights - ALX Oncology is participating in two significant healthcare conferences in New York, showcasing its commitment to advancing cancer therapies [1][2]. Group 1: Conference Participation - ALX Oncology leadership will engage in the Cantor Global Healthcare Conference on September 3, 2025, featuring a fireside chat and one-on-one meetings [2]. - The H.C. Wainwright 27th Annual Global Investment Conference will take place on September 9, 2025, with a focus on one-on-one meetings [2]. - Webcasts for both conferences will be available on ALX Oncology's website, with replays archived for up to 90 days [2]. Group 2: Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies aimed at treating cancer and improving patient survival [3]. - The lead therapeutic candidate, evorpacept, is being evaluated in multiple clinical trials across various cancer indications, indicating its potential as a cornerstone therapy in immuno-oncology [3]. - ALX2004, the second pipeline candidate, is an EGFR-targeted antibody-drug conjugate that entered Phase 1 trials in August 2025, highlighting the company's innovative approach to cancer treatment [3].
ALX Oncology Doses First Patient in Phase 1 Dose Escalation Trial Evaluating ADC ALX2004 for the Treatment of EGFR-Expressing Solid Tumors
Globenewswire· 2025-08-19 12:00
Core Insights - ALX2004 is a potential best- and first-in-class antibody-drug conjugate (ADC) designed for treating EGFR-expressing solid tumors, with components optimized to maximize the therapeutic window [1][4] - The first patient has been dosed in the Phase 1 clinical trial for ALX2004, marking a significant milestone for ALX Oncology [2][3] - Initial safety data from the trial is 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 [6] - The company’s lead candidate, evorpacept, is being evaluated in multiple clinical trials across various cancer indications [6] Clinical Trial Details - The Phase 1 clinical trial (NCT07085091) is an open-label multicenter study targeting advanced or metastatic EGFR-expressing solid tumors, including non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, and colorectal cancer [3][5] - The trial consists of a Phase 1a dose escalation followed by a Phase 1b dose expansion [3] Preclinical Data - Preclinical studies indicate that ALX2004 has a differentiated linker-payload construct, demonstrating superior stability and dose-dependent anti-tumor activity [5] - The preclinical model findings suggest a favorable safety profile, with no EGFR-related skin toxicity or payload-related interstitial lung disease observed at clinically relevant doses [5]