ALX Oncology Holdings Inc. - ALXO STOCK NEWS

ALX Oncology Holdings reported its Q2 2021 financial results, revealing a net loss of $16.3 million, or $0.40 per share, compared to a loss of $14.0 million last year. Cash and equivalents were $410 million, sufficient to fund operations through 2024. Key developments include the approval of 'evorpacept' as the generic name for ALX148 and initiation of several clinical trials, including ASPEN-04 and ASPEN-03. A collaboration with Eli Lilly was also established to evaluate evorpacept with CYRAMZA for HER2-positive G/GEJ cancer.

ALX Oncology Holdings Inc. has initiated the second Phase 2 trial, ASPEN-04, in collaboration with Merck, focusing on the combination of ALX148, KEYTRUDA, and standard chemotherapy for advanced head and neck squamous cell carcinoma (HNSCC). The study includes treatment-naive patients regardless of PD-L1 expression. The trial builds on promising results from the earlier ASPEN-01 study, which led to FDA Fast Track designation for ALX148 in HNSCC.

ALX Oncology has reported promising results from its ongoing ASPEN-01 trial, demonstrating a confirmed objective response rate (ORR) of 72% in patients with >2L HER2 positive gastric or gastroesophageal junction cancer. The estimates indicate an overall survival (OS) rate of 76% at 12 months, significantly outperforming historical controls. The combination therapy of ALX148 with trastuzumab and chemotherapy shows strong tolerability, with no maximum tolerated dose reached during the study. A conference call is scheduled for July 6, 2021 to discuss these findings further.

ALX Oncology announced that the FDA has lifted a partial clinical hold on its ongoing Phase 2 studies, ASPEN-03 and ASPEN-04, for the treatment of advanced head and neck cancer. The studies will evaluate the efficacy of ALX148 in combination with KEYTRUDA in patients with unresectable, recurrent HNSCC. The ongoing enrollment for ASPEN-03 has commenced, marking a significant milestone for the company as it seeks to expedite patient recruitment and address unmet medical needs in this area.

ALX Oncology (NASDAQ:ALXO) has initiated a collaboration with Eli Lilly to conduct a randomized Phase 2/3 study evaluating ALX148 in combination with CYRAMZA (ramucirumab) for treating HER2-positive gastric cancer. This decision follows promising results from the ongoing ASPEN-01 Phase 1b trial, which showed a 64% objective response rate in patients with previously low outcomes. This agreement underscores ALX Oncology's commitment to advancing ALX148 as a key immunotherapy option. Results from the Phase 1b trial will be presented at the ESMO 23rd World Congress on July 3, 2021.

BURLINGAME, Calif., May 18, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. (Nasdaq: ALXO) announced participation in two virtual investor conferences. The first is the UBS 2021 Global Healthcare Virtual Conference on May 24 at 4:00 PM ET, featuring a podium presentation. The second is the Jefferies 2021 Virtual Healthcare Conference on June 2 at 1:30 PM ET, structured as a fireside chat with analyst Michael Yee. Webcasts for both events will be available on the ALX Oncology website with replays accessible for 90 days.

ALX Oncology focuses on CD47 checkpoint therapies, with lead candidate ALX148 showing promising clinical results.

ALX Oncology Holdings reported a net loss of $14.2 million for Q1 2021, worsening from the prior year's loss of $7.4 million. Cash and cash equivalents totaled $429.9 million, sufficient to fund operations through 2024. Significant progress was made with the initiation of the Phase 2 ASPEN-03 study evaluating ALX148 in combination with KEYTRUDA for HNSCC. The company also strengthened its IP portfolio with a U.S. patent covering ALX148, set to expire in 2036. R&D expenses surged to $9.8 million, primarily due to increased clinical costs related to ALX148.

ALX Oncology has initiated the first Phase 2 study in collaboration with Merck, dosing the first patient in the ASPEN-03 trial. This trial evaluates the efficacy of ALX148 in combination with KEYTRUDA for treating advanced head and neck squamous cell carcinoma (HNSCC). ASPEN-03 is a randomized, open-label study building on promising data from the Phase 1 ASPEN-01 study, which led to Fast Track designation from the FDA for ALX148 in HNSCC. The trial aims to accelerate development in various cancer indications.

ALX Oncology (Nasdaq: ALXO) announced an upcoming oral presentation of their Phase 1b study results for ALX148 at the ESMO World Congress on Gastrointestinal Cancer, scheduled for July 3, 2021. The study evaluates ALX148 in combination with trastuzumab, ramucirumab, and paclitaxel for patients with advanced gastric or gastroesophageal junction cancer. This presentation may highlight the therapeutic potential of ALX148 and its impact on treatment outcomes for patients, while contributing to the ongoing clinical development of their immuno-oncology pipeline.