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ALX Oncology Announces Pricing of Underwritten Offering
Globenewswire· 2026-01-30 13:30
Core Viewpoint - ALX Oncology Holdings Inc. has announced the pricing of an underwritten offering of common stock and pre-funded warrants, aiming to raise approximately $150 million to support its clinical development programs and general corporate purposes [1][3]. Group 1: Offering Details - ALX Oncology is selling 76,979,112 shares of common stock at an offering price of $1.57 per share and pre-funded warrants to purchase 18,574,120 shares at $1.569 each [1]. - The gross proceeds from the offering are expected to be around $150 million before deducting underwriting discounts and commissions [1]. - The offering is expected to close on or about February 2, 2026, subject to customary closing conditions [1]. Group 2: Investors and Participation - The financing is led by new investors RA Capital Management and TCGX, with participation from various other investors including 5AM Ventures, Blackstone Multi-Asset Investing, and others [2]. Group 3: Use of Proceeds - The net proceeds from the offering will be used to fund the continued clinical development of evorpacept and the ALX2004 program, as well as for working capital and other general corporate purposes [3]. Group 4: Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment, with its lead candidate evorpacept currently in multiple clinical trials [6]. - The second pipeline candidate, ALX2004, is an EGFR-targeted antibody-drug conjugate undergoing a Phase 1 dose-escalation trial in patients with EGFR-expressing solid tumors [6].
New Data Demonstrate CD47 Expression Level Helps Predict Response to ALX Oncology’s Evorpacept in Combination with Ziihera (zanidatamab-hrii) in Advanced HER2-Positive Breast Cancer
Globenewswire· 2026-01-30 13:15
Core Insights - ALX Oncology announced new data from a Phase 1b/2 clinical trial evaluating the CD47-inhibitor evorpacept in combination with Jazz Pharmaceuticals' ZIIHERA® for metastatic breast cancer, reinforcing CD47 as a predictive biomarker for treatment response [1][2] Group 1: Clinical Trial Findings - The Phase 1b/2 trial demonstrated promising anti-tumor activity and a manageable safety profile in heavily pretreated HER2-positive breast cancer patients, with a median of six prior therapies [2] - The combination treatment achieved a confirmed objective response rate (cORR) of 56% (5 out of 9 patients) and a median progression-free survival (mPFS) of 7.4 months [2] - Additional exploratory analysis indicated that responses were largely restricted to patients with higher CD47 expression, supporting findings from the ASPEN-06 trial [3] Group 2: Future Directions - The company plans to adopt a biomarker-driven approach for patient selection in future trials involving evorpacept and HER2-targeted agents [2] - Full biomarker analysis from the Phase 1b/2 trial has been submitted for presentation at an upcoming scientific congress [4] Group 3: Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment, with evorpacept as a lead candidate [5] - The company is also advancing a second pipeline candidate, ALX2004, which is currently in a Phase 1 trial for EGFR-expressing solid tumors [5]
New Data Demonstrate CD47 Expression Level Helps Predict Response to ALX Oncology's Evorpacept in Combination with Ziihera (zanidatamab-hrii) in Advanced HER2-Positive Breast Cancer
Globenewswire· 2026-01-30 13:15
Core Insights - ALX Oncology announced new data from a Phase 1b/2 clinical trial evaluating the investigational CD47-inhibitor evorpacept in combination with Jazz Pharmaceuticals' ZIIHERA® for metastatic breast cancer, reinforcing CD47 as a predictive biomarker for treatment response [1][2] Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment, with its lead candidate evorpacept showing potential as a cornerstone therapy in immuno-oncology [5] Clinical Trial Findings - The Phase 1b/2 trial demonstrated promising anti-tumor activity and a manageable safety profile, with a confirmed objective response rate of 56% and a median progression-free survival of 7.4 months in heavily pretreated HER2-positive breast cancer patients [2][3] - Additional exploratory analysis indicated that responses were primarily observed in patients with higher CD47 expression, supporting the predictive biomarker role of CD47 [3] Future Directions - The company plans to adopt a biomarker-driven approach for patient selection in future trials, particularly for combinations of evorpacept with HER2-targeted agents, and is confident in the ongoing ASPEN-09-Breast Phase 2 trial [2]
ALX Oncology Holdings Inc. (ALXO) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Seeking Alpha· 2026-01-15 22:25
Core Insights - ALX Oncology has had a significant year, with seven different data sets read out, indicating strong progress in its clinical programs [2] - The company is focused on developing two clinical stage programs, evorpacept and ALX2004, which are differentiated within their class [2] - Evorpacept targets CD47, a crucial element in the immune system and oncology, which has historically been challenging to address [2]
ALX Oncology to Present at the 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2026-01-08 16:00
Core Insights - ALX Oncology Holdings Inc. is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment and improving patient survival [3] Group 1: Company Overview - ALX Oncology is advancing a pipeline that includes its lead candidate, evorpacept, which shows promise as a cornerstone therapy in immuno-oncology [3] - The company is also developing ALX2004, an EGFR-targeted antibody-drug conjugate, currently in a Phase 1 dose-escalation trial for patients with EGFR-expressing solid tumors [3] Group 2: Upcoming Events - ALX Oncology will participate in the 44th Annual J.P. Morgan Healthcare Conference, with a corporate presentation scheduled for January 15, 2026, at 12:00 p.m. Pacific Time [1] - A live webcast of the presentation will be available on the company's website, with a replay accessible for up to 90 days post-event [2]
ALX Oncology to Present at the 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2026-01-08 16:00
Group 1 - ALX Oncology Holdings Inc. is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment and improving patient survival [1][3] - The company will participate in the 44th Annual J.P. Morgan Healthcare Conference, with a presentation scheduled for January 15, 2026, at 12:00 p.m. Pacific Time [1] - ALX Oncology's lead candidate, evorpacept, is being evaluated in multiple clinical trials across various cancer indications, aiming to establish a foundation for future immuno-oncology therapies [3] Group 2 - The second pipeline candidate, ALX2004, is an EGFR-targeted antibody-drug conjugate currently undergoing a Phase 1, dose-escalation trial for patients with EGFR-expressing solid tumors [3] - Additional information about ALX Oncology can be found on their website and LinkedIn [3]
ALX Oncology Advances Separate Clinical Trials Evaluating Investigational CD47-Inhibitor Evorpacept and Novel EGFR-Targeted Antibody-Drug Conjugate ALX2004
Globenewswire· 2026-01-08 13:30
Core Insights - ALX Oncology has initiated the Phase 2 ASPEN-09-Breast trial for evorpacept in HER2-positive metastatic breast cancer, with interim analysis expected in Q3 2026 [1][5] - The Phase 1 trial for ALX2004 has progressed to the third dose cohort, with initial safety data anticipated in 1H 2026 [2][7] Group 1: Clinical Trials - The Phase 2 ASPEN-09-Breast trial will evaluate evorpacept in combination with trastuzumab and physician's choice of chemotherapy in 80 patients previously treated with ENHERTU [4] - The primary endpoint of the ASPEN-09-Breast trial is overall response rate (ORR) in HER2-positive patients confirmed by circulating tumor DNA (ctDNA) [5] - The Phase 1 trial for ALX2004 is a first-in-human study targeting EGFR-expressing solid tumors, currently enrolling patients in a dose escalation portion [6] Group 2: Drug Mechanisms and Efficacy - Evorpacept is the first CD47 inhibitor to show significant tumor response and a well-tolerated safety profile in a randomized trial, demonstrating benefits in patients with high CD47 expression levels [3] - ALX2004 aims to address toxicity challenges associated with earlier generation EGFR-targeted antibody-drug conjugates, with no dose-limiting toxicities observed in prior cohorts [2][7] Group 3: Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel cancer therapies, with evorpacept as a lead candidate [8][9] - The company is advancing a pipeline of therapies designed to treat various cancer indications, with ongoing clinical trials for both evorpacept and ALX2004 [9]
After-Hours Gainers: ALXO, GMED, ACRV, And Biotech Peers Rally On Trial Data And Earnings Updates
RTTNews· 2026-01-08 03:14
Group 1: Biotechnology and Healthcare Companies Performance - Several biotechnology and healthcare companies experienced notable gains in after-hours trading due to clinical updates, financial results, and upcoming industry presentations [1] Group 2: ALX Oncology Holdings Inc. - ALX Oncology Holdings Inc. (ALXO) surged 10.17% to $1.30 after announcing positive data from a Phase 2 trial of its lead candidate, evorpacept, in combination with rituximab and lenalidomide for patients with indolent B-cell non-Hodgkin lymphoma [2] - The findings are scheduled to be presented on December 7, 2025, at the American Society of Hematology (ASH) Annual Meeting in Orlando, Florida [2] Group 3: Globus Medical, Inc. - Globus Medical, Inc. (GMED) climbed 9.34% to $99.00 following preliminary unaudited sales results, reporting fourth-quarter 2025 sales of approximately $823.2 million, a 25.2% increase year-over-year [3] - Full-year 2025 sales are expected to reach $2.936 billion, representing a 16.5% increase from the prior year [3] - The company set its 2026 revenue guidance between $3.18 billion and $3.22 billion, with projected non-GAAP earnings per share in the range of $4.30 to $4.40 [3] Group 4: Acrivon Therapeutics, Inc. - Acrivon Therapeutics, Inc. (ACRV) rose 6.44% to $3.14 after announcing plans to release clinical data updates for ACR-368 and ACR-2316 on January 8, 2026 [4] Group 5: Other Companies - AnaptysBio, Inc. (ANAB) advanced 1.75% to $46.00 after confirming that CEO Daniel Faga will present at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026 [5] - Omeros Corp. (OMER) added 4.47% to $14.72 without any new corporate updates [6] - EUDA Health Holdings Limited (EUDA) increased 3.73% to $2.50 after amending its warrant agreement with Streeterville Capital, LLC [6] - TherapeuticsMD, Inc. (TXMD) rose 5.34% to $2.15 in after-hours trading, with no new announcements reported [6] - Pyxis Oncology, Inc. (PYXS) gained 4.93% to $1.49 without any fresh news [7]
ALX Oncology Announces Positive Results from Ongoing Investigator-Sponsored Phase 2 Trial Evaluating Evorpacept in Combination with Standard-of-Care Treatment in Patients with Indolent B-cell Non-Hodgkin Lymphoma, at ASH Annual Meeting
Globenewswire· 2025-12-07 13:00
Core Insights - The combination of evorpacept, rituximab, and lenalidomide achieved a complete response (CR) rate of 92% in patients with untreated indolent non-Hodgkin lymphoma (iNHL), significantly higher than the historical CR rate of approximately 50% for rituximab alone [1][2] - The treatment regimen was well-tolerated and demonstrated impressive anti-tumor activity in the frontline setting, with a one-year progression-free survival (PFS) rate of 91% and a one-year overall survival (OS) rate of 100% [2] Study Details - The Phase 2 investigator-sponsored trial enrolled 24 patients, including 14 with follicular lymphoma and 10 with marginal zone lymphoma, and met the primary objective of achieving a CR rate above 80% [2] - The trial was led by Dr. Paolo Strati from The University of Texas MD Anderson Cancer Center, and the results were presented at the American Society of Hematology (ASH) Annual Meeting 2025 [3] Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment, with evorpacept as its lead candidate [4] - The company is also advancing a second pipeline candidate, ALX2004, which is an EGFR-targeted antibody-drug conjugate currently in Phase 1 trials [5]
ALX Oncology Holdings (NasdaqGS:ALXO) FY Conference Transcript
2025-12-03 15:32
Summary of ALX Oncology Holdings FY Conference Call Company Overview - **Company**: ALX Oncology Holdings (NasdaqGS:ALXO) - **Founded**: 2015 - **Lead Program**: Evorpacept, a CD47 blocker with a unique mechanism of action - **New Program**: ALX 2004, an EGFR-targeted antibody-drug conjugate (ADC) currently in clinical trials [2][4] Core Points and Arguments CD47 Mechanism and Evorpacept - Evorpacept is designed to block the "don't eat me" signal from CD47, which is crucial for immune evasion by cancer cells [2][3] - The company claims to be the only CD47 blocker in development with a dead Fc, allowing for full blockade of the "eat me" signal [3] - The approach has been validated through four clinical studies, demonstrating its potential effectiveness [3] Clinical Trials and Results - **Gastric Cancer Trial**: - Phase 2 trial showed a 41% overall response rate (ORR) for evorpacept plus TRP compared to 26% in the control arm [9] - In patients retaining HER2 positivity, the response rate was 49% versus 25% in the control arm, with a median duration of response of 15.7 months [11] - The FDA did not grant accelerated approval due to the availability of Enhertu, leading the company to refocus on breast cancer [9][11] - **Breast Cancer Studies**: - The company is advancing a study combining evorpacept with Herceptin and chemotherapy, with interim data expected in Q3 2026 [16][17] - The study aims to evaluate efficacy based on CD47 expression levels [16] Biomarker Development - The company is developing a companion diagnostic to identify patients with high CD47 expression, which is crucial for treatment selection [15][16] - CD47 is recognized as a poor prognostic marker across various cancers, but its predictive use for treatment decision-making is still under development [15] ALX 2004 Development - ALX 2004 is an EGFR-targeting ADC developed in-house, with a focus on optimizing linker payloads and epitope selection to address past challenges in EGFR-targeted therapies [22][23] - The phase 1 trial is being conducted in multiple solid tumors, with initial safety data expected in the first half of 2026 [24][25] Competitive Landscape - The company believes it has a unique asset in ALX 2004, with a distinct epitope and linker payload compared to existing EGFR-targeted ADCs [25][26] - There is competition from various ADCs, particularly from China, but ALX Oncology claims to be first in treating U.S. patients with this specific approach [26] Financial Position and Future Outlook - The company has sufficient cash to support operations through Q1 2027, with several important milestones expected in the next 12 months [27] - Key upcoming events include safety data for ALX 2004 and interim data for the breast cancer study involving evorpacept [27] Additional Important Points - The company is exploring partnerships, particularly in Asia, to expand its market reach for gastric cancer treatments [14] - The strategic shift towards focusing on anti-cancer antibodies for evorpacept combinations reflects a response to clinical learnings over the past decade [5][6]