Page 1

ALX ONCOLOGY ALX Oncology Reports Second Quarter 2021 Financial Results and Provides Clinical Development and Operational Highlights August 12 , 2021 BURLINGAME , Calif . , Aug. 12 , 2021 ( GLOBE NEWSWIRE ) -- ALX Oncology Holdings Inc. , ( " ALX Oncology " ) ( Nasdaq : ALXO ) a clinical - stage immuno - oncology company developing therapies that block the CD47 checkpoint pathway , today reported financial results for the second quarter ended June 30 , 2021 and provided clinical development and operational highlights . " We are pleased to report on the substantial progress we made since the prior quarter with our lead product candidate , ALX148 , and that the United States Adopted Names ( USAN ) Council has approved ' evorpacept ' as the nonproprietary ( generic ) name for ALX148 , " said Jaume Pons , Ph.D. , Founder , President and Chief Executive Officer of ALX Oncology . " Our highlights include the presentation of additional positive Phase 1b data in second - line or greater HER2 positive gastric or gastroesophageal junction cancer from our ASPEN - 01 trial during an oral session at the ESMO World Congress on Gastrointestinal Cancer ; these results provide the basis for initiating a randomized Phase 2/3 trial in the same setting ( ASPEN - 06 ) scheduled to start in the second half of this year . " " We recently dosed the first patient in our Phase 2 ASPEN - 04 trial in first line metastatic or unresectable recurrent head and neck squamous cell carcinoma in combination with KEYTRUDAⓇ and chemotherapy , are continuing enrollment in our Phase 2 ASPEN - 03 trial in first line metastatic or unresectable , PD - L1 positive recurrent head and neck cancer in combination with KEYTRUDA , and plan to present full results of the Phase 1b study ( ASPEN - 01 ) in the fourth quarter of this year . In addition , we plan to present results from our Phase 1 study in myelodysplastic syndromes , to initiate a Phase 2 study in the same setting ( ASPEN - 02 ) , as well as to initiate a Phase 1 study in acute myeloid leukemia ( ASPEN - 05 ) , " Dr. Pons continued . Recent Clinical Developments for Evorpacept ( Also known as ALX148 ) • First Patient Dosed in Phase 2 ASPEN - 04 Study • In July 2021 , dosed first patient in the Phase 2 ASPEN - 04 study evaluating the combination of evorpacept , a next generation CD47 blocker , with KEYTRUDA ( pembrolizumab ) , Merck's anti - PD - 1 therapy , and standard 5 - fluorouracil and platinum chemotherapy for the first line ( " 1L " ) treatment of patients with metastatic or unresectable , recurrent head and neck squamous cell carcinoma ( " HNSCC " ) . In June 2021 , the U.S. Food and Drug Administration ( " FDA " ) informed ALX Oncology that it reviewed its standard non - clinical safety study and has lifted the previously set partial clinical hold and cap on patient enrollment . • First Patient Dosed in Phase 2 ASPEN - 03 Study • In May 2021 , dosed first patient in the Phase 2 ASPEN - 03 study , which is also evaluating the efficacy of evorpacept in combination with KEYTRUDA ( pembrolizumab ) for the 1L treatment of patients with PD - L1 expressing metastatic or unresectable , recurrent HNSCC with a combined positive score ( " CPS " ) ≥ 1. In June 2021 , the FDA informed ALX Oncology that it reviewed its standard non - clinical safety study and has lifted the previously set partial clinical hold and cap on patient enrollment . • Data for Phase 1b ASPEN - 01 Study Presented at 23rd ESMO World Congress on Gastrointestinal Cancer o In July 2021 , updated clinical data from the Phase 1b ASPEN - 01 trial evaluating evorpacept in combination with trastuzumab and CYRAMZAⓇ ( ramucirumab ) for the treatment of gastric or gastroesophageal junction cancer ( " G / GEJ " ) were shared in an oral presentation at the 23 rd ESMO World Congress on Gastrointestinal Cancer . Data showed that evorpacept in combination with trastuzumab and ramucirumab is highly active and well - tolerated in patients with second line ( " ≥2L " ) or greater HER2 positive G / GEJ cancer . • Collaboration and Supply Agreement Entered with Eli Lilly o In June 2021 , ALX Oncology entered into a clinical trial collaboration and supply agreement with Eli Lilly and Company to evaluate the combination of evorpacept with CYRAMZA ( ramucirumab ) , Lilly's anti - VEGFR2 antibody , for the treatment of patients with HER2 positive G / GEJ . Under the terms of the agreement , ALX Oncology will conduct a Phase 2/3 study to evaluate the efficacy of evorpacept in combination with ramucirumab , trastuzumab ,