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ALX Oncology(ALXO) - 2025 Q3 - Quarterly Results
2025-11-07 13:17
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]
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].