Earnings release
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ALX ONCOLOGY ALX Oncology Reports First Quarter 2021 Financial Results and Provides Clinical Development and Operational Highlights May 17 , 2021 BURLINGAME , Calif . , May 17 , 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 first quarter ended March 31 , 2021 and provided recent clinical development and operational highlights . " Having achieved important milestones in the first quarter of 2021 , we look forward to what we expect will be another exciting year of substantial progress for our lead candidate , ALX148 , as we prepare to initiate several clinical trials in combination with other agents in a variety of indications , as well as multiple anticipated data readouts during the year , " said Jaume Pons , Ph.D. , Founder , President and Chief Executive Officer of ALX Oncology . " We recently dosed the first patient in our Phase 2 study ( ASPEN - 03 ) to evaluate ALX148 in combination with KEYTRUDA Ⓡ in first line treatment of patients with PD - L1 expressing metastatic or unresectable , recurrent head and neck squamous cell carcinoma ( " HNSCC " ) and we are preparing to initiate a second Phase 2 study ( ASPEN - 04 ) in the coming weeks with ALX148 in combination with KEYTRUDA and standard chemotherapy in a similar patient population but regardless of PD - L1 expression status . We also look forward to presenting additional results from a Phase 1b study ( ASPEN - 01 ) of ALX148 in combination with trastuzumab , ramucirumab and paclitaxel in patients with HER2 - positive gastric / gastroesophageal junction cancer ( " G / GEJ " ) at the upcoming ESMO 23 rd World Congress on Gastrointestinal Cancer in July , " Dr. Pons continued . Recent Clinical Developments for ALX148 : • Phase 2 ASPEN - 03 study In May 2021 , dosed first patient in the Phase 2 ASPEN - 03 study evaluating the combination of ALX148 , a next generation CD47 blocker , with KEYTRUDAⓇ ( pembrolizumab ) , Merck's anti - PD - 1 therapy , for the treatment of patients with HNSCC . • Strengthened IP Portfolio Covering ALX148 In April 2021 , ALX Oncology announced that the post - grant review period for granted U.S. Patent No. 10,696,730 ended on March 30 , 2021. This patent covers the lead product candidate ALX148 , a next generation CD47 - blocking therapeutic that combines a high - affinity signal regulatory protein - alpha ( " SIRPa " ) CD47 - binding domain fused with an inactivated , proprietary Fc domain . The U.S. patent is not expected to expire before August 5 , 2036 , excluding patent term adjustments or extensions . Recent Operational Highlights : • In May 2021 , reported the appointment of Shelly Pinto as VP Finance and Chief Accounting Officer . Ms. Pinto was most recently VP of Finance and Operations at Tizona Therapeutics and is a Certified Public Accountant . First Quarter 2021 Financial Results : • Cash and Cash Equivalents : Cash and cash equivalents as of March 31 , 2021 were $ 429.9 million . ALX Oncology believes its cash and cash equivalents is sufficient to fund planned operations through 2024 . • Net loss : Generally accepted accounting principles ( GAAP ) net loss attributable to common stockholders was $ 14.2 million , or $ 0.35 per basic and diluted share and $ 7.4 million , or $ 2.37 per basic and diluted share for the three months ended March 31 , 2021 , and 2020 , respectively . Non - GAAP net loss attributable to common stockholders was $ 12.4 million for the three months ended March 31 , 2021 , as compared to $ 7.1 million for the three months ended March 31 , 2020. A reconciliation of GAAP to non - GAAP financial results can be found at the end of this news release . • Related - party Revenue : There was no related - party revenue for the three months ended March 31 , 2021 , compared to $ 0.7 million for the same prior - year period . The decrease in related - party revenue relates to the termination of the research and development agreement with Tallac Therapeutics , Inc. in July 2020 . • Research and Development ( " R & D " ) Expenses : R & D expenses consist primarily of pre - clinical , clinical and