SOUTH SAN FRANCISCO, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today announced plans to report its third quarter 2025 financial results and provide a business update on Friday, November 7th, 2025, before market open. The company will be hosting a teleconference in conjunction with this press release w ...

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]

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]

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]

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]

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]

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]

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].

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]

Financial Data and Key Metrics Changes - The company has extended its cash runway guidance into 2027, positioning itself to achieve multiple value-enhancing data milestones in the upcoming years [6][38] - The financials reflect a significant decline in clinical trial spending as multiple legacy trials are closing out, which will positively impact cash flow [38] Business Line Data and Key Metrics Changes - The analysis of the ASPEN six trial indicates that CD47 expression is a key predictive biomarker for clinical response, with a notable increase in overall response rates (ORR) for patients with high CD47 expression [3][8] - The company is modifying its Phase II clinical trial in breast cancer to pursue a CD47 and HER2 biomarker-driven strategy, enhancing the potential for targeted oncology approaches [4][12] Market Data and Key Metrics Changes - Approximately 20,000 patients are identified as addressable in the HER2 positive and CD47 high segment, representing a market opportunity estimated between $2 billion to $4 billion [30] - The company anticipates that CD47 overexpression is found in roughly 50% to 70% of HER2 positive breast cancer patients, indicating a significant commercial opportunity [13][30] Company Strategy and Development Direction - The company is focused on advancing its HER2 positive breast cancer program with a CD47 biomarker-driven approach, which has been derisked by positive data from two different HER2 positive cancers [22][36] - The development strategy includes pursuing a targeted IO breakthrough with EVO, aiming to replicate successful results across various tumor types [9][12] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the potential of CD47 as a predictive biomarker, which could facilitate smaller and faster future studies, enhancing the ability to select patients effectively [40] - The management team is optimistic about the upcoming data presentations and the implications for future clinical trials, particularly in breast cancer [41] Other Important Information - The company is set to present full data from the ASPEN six trial at an upcoming medical conference in Q4 of this year, which is expected to provide further insights into the efficacy of EVO [8][20] - The clinical pipeline remains focused on the combination of evorpercept with anti-cancer antibodies, with a priority on the HER2 positive breast cancer program [36][37] Q&A Session Summary Question: Do you need to meet with FDA to finalize trial design changes for Aspen breast? - The company has submitted the amendment for the Aspen breast study to the FDA and is ready to proceed without any holdup [44] Question: Can you frame investigator feedback on the CD47 biomarker approach? - Feedback from investigators has been positive, with enthusiasm for the CD47 biomarker and its potential to address unmet needs in patients progressing on HER2 therapies [46] Question: What kind of data would give confidence to continue pursuing the biomarker approach? - The company is looking for response rates in the high 30s to 40% range to consider the data compelling enough for further development [48] Question: Will the current Phase II study support registration? - The current study is designed to inform decision-making for future registrational studies, with the potential for accelerated approval depending on the data [55][56] Question: How does the baseline characteristic compare between CD47 high and low patient groups? - The baseline characteristics are generally well balanced, and further details will be shared at a medical meeting [76] Question: Is there any data on CD47 expression post HER2 treatment? - There is evidence suggesting that CD47 levels may increase with subsequent lines of therapy, indicating a potential resistance mechanism [81]