On May 9, 2024 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, reported financial results for the first quarter ended March 31, 2024, and provided a corporate update (Press release, ALX Oncology, MAY 9, 2024, View Source [SID1234643034]).
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"We entered the quarter with a great deal of momentum having achieved a key validating development milestone for our platform asset evorpacept in Q4 2023 by reporting positive results in a prespecified randomized interim analysis of ASPEN-06’s Phase 2 clinical trial in advanced HER2-positive gastric/GEJ cancer, becoming the first CD47 blocker to demonstrate anti-tumor activity in a global randomized study in solid tumors," said Jason Lettmann, Chief Executive Officer of ALX Oncology. "On the heels of this outstanding accomplishment, our first quarter efforts were focused on ensuring optimal clinical and operational execution as we advance our robust and maturing clinical-stage pipeline of best-in-class oncology programs that are reporting multiple value inflection datapoints in the coming months."
First Quarter 2024 Highlights and Recent Developments
Reported positive data from an ongoing investigator-sponsored trial ("IST") Phase 1/2 clinical trial of evorpacept in combination with standard-of-care in patients with relapsed or refractory B-cell non-Hodgkin lymphoma ("R/R B-NHL") in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on April 9, 2024, in San Diego.
Twenty patients with indolent (n=18) and aggressive (n=2) R/R B-NHL received evorpacept plus standard rituximab and lenalidomide ("R2").
Evorpacept plus R2 was well tolerated with a safety profile similar to historical R2.
The combination achieved promising initial activity with a best overall response rate ("ORR") of 94% and a complete response rate ("CRR") of 83% in patients with indolent R/R B-NHL (R2 historical CRR benchmark is 34%).
The clinical trial is conducted and sponsored by the University of Texas MD Anderson Cancer Center.
Received acceptance of two evorpacept abstracts from the 2024 American Society of Cancer Oncology ("ASCO") Annual Meeting taking place in Chicago from May 31-June 4, 2024.
Evorpacept plus enfortumab vedotin in patients with locally advanced or metastatic urothelial carcinoma: Phase 1a dose escalation results
Session Type and Title: Poster Presentation – Genitourinary Cancer – Kidney and Bladder
Session Date and Time: Sunday, June 2, 2024, 9:00 AM – 12:00 PM CDT
Location: Hall A
Abstract Number: 4575 (ALX Oncology Sponsored Clinical Trial)
Results of a Phase 2 study of evorpacept (ALX148), cetuximab and pembrolizumab in patients with refractory microsatellite stable metastatic colorectal cancer
Session Type and Title: Poster Presentation – Gastrointestinal Cancer – Colorectal and Anal
Session Date and Time: Saturday, June 1, 2024, 1:30 PM – 4:30 PM CDT
Location: Hall A
Abstract Number: 3530 (IST conducted by the University of Colorado Cancer Center and sponsored by the Academic GI Cancer Consortium)
Announced initiation of a Phase 2 IST of neoadjuvant radiation and evorpacept in combination with KEYTRUDA (pembrolizumab) in patients with previously untreated and early-stage locally advanced, resectable, human papillomavirus-mediated oropharyngeal cancer.
The clinical trial is conducted and sponsored by the Hanna and Mark Gleiberman Head and Neck Cancer Center at the University of California, San Diego.
Announced appointment of Allison Dillon, Ph.D., as Chief Business Officer.
Upcoming Clinical Milestones for Evorpacept’s Development Pipeline
Urothelial Carcinoma – Data from a Phase 1b ASPEN-07 clinical trial with PADCEV (enfortumab vedotin-ejfv) (ASCO: Embargo to lift on full abstract May 23, 2024; Poster to be presented on June 2, 2024)
Gastric/Gastroesophageal Junction ("GEJ") Cancer – Top line results from all 122 subjects in a Phase 2 randomized clinical trial of ASPEN-06 (July 2024)
Breast Cancer – Top line results from a Phase 1b I-SPY TRIAL with ENHERTU (fam-trastuzumab deruxtecan-nxki) (Q4 2024)
Head and Neck Squamous Cell Carcinoma – Top line results from a Phase 2 randomized clinical trial of ASPEN-03 with KEYTRUDA (Q4 2024/Q1 2025)
Head and Neck Squamous Cell Carcinoma – Top line results from a Phase 2 randomized clinical trial of ASPEN-04 with KEYTRUDA and chemotherapy (Q4 2024/Q1 2025)
Gastric/GEJ Cancer – Initiation of Phase 3 registrational randomized clinical trial for evorpacept (Q4 2024)
First Quarter 2024 Financial Results:
Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of March 31, 2024, were $184.5 million. Subsequent to March 31, 2024, the Company issued additional shares of common stock under its at-the-market ("ATM") offering for approximately $26.2 million in net proceeds, after deducting commissions. The Company believes its cash, cash equivalents and investments, recent proceeds from sales under its ATM offering, along with the ability to draw down an additional $40 million of its term loan are sufficient to fund planned operations well into Q1 2026.
Research and Development ("R&D") Expenses: R&D expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of the Company’s current lead product candidate, evorpacept, and R&D employee-related expenses. These expenses for the three months ended March 31, 2024, were $31.7 million, compared to $24.8 million for the prior-year period. The $6.9 million increase was primarily attributable to increased clinical development costs from an increased number of active trials and patient enrollment as well as manufacturing of clinical trial materials to support a higher number of active clinical trials and future expected patient enrollment related to evorpacept, an increase of in personnel and related costs primarily driven by headcount growth, an increase in stock-based compensation expense related to a reclassification of stock-based compensation from G&A to R&D because of the change in roles for our former Chief Executive Officer who transitioned to the Chief Scientific Officer in September 2023, and an increase in other research costs primarily due to a development milestone payment related to ScalmiBio.
General and Administrative ("G&A") Expenses: G&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. These expenses for the three months ended March 31, 2024, were $6.0 million, compared to $7.4 million for the prior year period. The $1.4 million decrease was primarily due to lower stock-compensation expense related to a reclassification of stock-based compensation which increased R&D stock-based compensation as detailed under R&D expenses.
Net loss: GAAP net loss was $35.6 million for the three months ended March 31, 2024, or ($0.71) per basic and diluted share, as compared to a GAAP net loss of $30.2 million for the three months ended March 31, 2023, or ($0.74) per basic and diluted share. Non-GAAP net loss was $28.5 million for the three months ended March 31, 2024, as compared to a non-GAAP net loss of $23.8 million for the three months ended March 31, 2023. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.