Full Press Release Details
ALX Oncology Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Clinical Development and Operational Highlights and Upcoming Milestones
SOUTH SAN FRANCISCO, Calif., Feb. 28, 2022 (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 fourth quarter and year ended December 31, 2021 and provided clinical development and operational highlights.
"ALX Oncology achieved key milestones in 2021 to advance our lead program, evorpacept, a next-generation CD47 blocker, through multiple clinical trials," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "Notable accomplishments included initiating two Phase 2 trials in head and neck squamous cell carcinoma ("HNSCC") and presenting encouraging Phase 1b data from the ASPEN-01 trial in gastric/gastroesophageal junction ("GEJ") cancer and HNSCC, along with early Phase 1a data from the ASPEN-02 trial in myelodysplastic syndromes ("MDS"). Data from these trials also showed evorpacept to be well tolerated when combined with anti-cancer antibodies and multi-agent chemotherapy regimens in solid tumors and with azacitidine in MDS."
Dr. Pons added: "2022 is expected to be another productive year with the anticipated initiation of a randomized Phase 2/3 clinical trial of evorpacept in combination with trastuzumab, ramucirumab and paclitaxel in patients with 2nd line or greater gastric/GEJ cancer and the expected completion of enrollment and dose optimization data readout from our Phase 1b clinical trial of evorpacept in combination with azacitidine in patients with MDS. The design of evorpacept, with an inactive Fc, continues to set us apart from competing CD47 blockers to date. Our data suggest that evorpacept's inactive Fc approach shows greater tolerability than CD47 blocking approaches using an active Fc domain, several of which have shown significant cytopenias in the clinic. Additionally, our initial clinical data show anti-tumor activity on par or better than other such agents."
Anticipated Key Clinical Milestones for 2022
Recent Clinical Developments for Evorpacept (ALX148)
Recent Corporate Updates
Full Year and Fourth Quarter 2021 Financial Results:
ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, evorpacept, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. Evorpacept has demonstrated promising clinical responses across a range of hematologic and
solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of evorpacept for the treatment of multiple solid tumor indications and hematologic malignancies, including acute myeloid leukemia and myelodysplastic syndromes.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
ALX ONCOLOGY HOLDINGS INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Related-party revenue | $ | - | $ | - | $ | - | $ | 1,182 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 20,894 | 12,142 | 60,170 | 28,961 | ||||||||||||
| General and administrative | 7,578 | 5,683 | 23,385 | 14,809 | ||||||||||||
| Cost of services for related-party revenue | - | - | - | 1,075 | ||||||||||||
| Total operating expenses | 28,472 | 17,825 | 83,555 | 44,845 | ||||||||||||
| Loss from operations | (28,472 | ) | (17,825 | ) | (83,555 | ) | (43,663 | ) | ||||||||
| Interest expense | (3 | ) | (151 | ) | (13 | ) | (811 | ) | ||||||||
| Other income (expense), net | 16 | 5 | 84 | (404 | ) | |||||||||||
| Loss on early debt extinguishment | - | (621 | ) | - | (621 | ) | ||||||||||
| Loss before income taxes | (28,459 | ) | (18,592 | ) | (83,484 | ) | (45,499 | ) | ||||||||
| Income tax benefit (provision) | 21 | (182 | ) | 21 | (241 | ) | ||||||||||
| Net loss and comprehensive loss | (28,438 | ) | (18,774 | ) | (83,463 | ) | (45,740 | ) | ||||||||
| Cumulative dividends allocated to preferred stockholders | - | - | - | (5,202 | ) | |||||||||||
| Net loss attributable to common stockholders | $ | (28,438 | ) | $ | (18,774 | ) | $ | (83,463 | ) | $ | (50,942 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.70 | ) | $ | (0.50 | ) | $ | (2.07 | ) | $ | (2.76 | ) | ||||
| Weighted-average shares of common stock used to compute net loss per share attributable to common stockholders, basic and diluted | 40,527,314 | 37,642,897 | 40,308,050 | 18,485,343 |
Condensed Consolidated Balance Sheet Data
| December 31, 2021 | December 31, 2020 | |||||||
| Cash and cash equivalents | $ | 363,667 | $ | 434,219 | ||||
| Total assets | $ | 380,183 | $ | 436,054 | ||||
| Total liabilities | $ | 17,134 | $ | 6,209 | ||||
| Accumulated deficit | $ | (201,985 | ) | $ | (118,522 | ) | ||
| Total stockholders' equity | $ | 363,049 | $ | 429,845 |
GAAP to Non-GAAP Reconciliation
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| GAAP net loss attributable to common stockholders, as reported | $ | (28,438 | ) | $ | (18,774 | ) | $ | (83,463 | ) | $ | (50,942 | ) | ||||
| Adjustments: | ||||||||||||||||
| Stock-based compensation expense | 5,686 | 1,743 | 13,914 | 5,436 | ||||||||||||
| Accretion of term loan | - | 82 | - | 421 | ||||||||||||
| Mark-to-market adjustment on financial instruments | - | - | - | 650 | ||||||||||||
| Loss on early debt extinguishment | - | 621 | - | 621 | ||||||||||||
| Total adjustments | 5,686 | 2,446 | 13,914 | 7,128 | ||||||||||||
| Non-GAAP net loss attributable to common stockholders | $ | (22,752 | ) | $ | (16,328 | ) | $ | (69,549 | ) | $ | (43,814 | ) |
Use of Non-GAAP Financial Measures
We supplement our consolidated financial statements presented on a GAAP basis by providing additional measures which may be considered "non-GAAP" financial measures under applicable Securities and Exchange Commission rules. We believe that the disclosure of these non-GAAP financial measures provides our investors with additional information that reflects the amounts and financial basis upon which our management assesses and operates our business. These non-GAAP financial measures are not in accordance with generally accepted accounting principles and should not be viewed in isolation or as a substitute for reported, or GAAP, net loss, and are not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP.
"Non-GAAP net loss attributable to common stockholders" is not based on any standardized methodology prescribed by GAAP and represent GAAP net loss adjusted to exclude (1) stock-based compensation expense, (2) accretion of term loan (interest expense related to ALX Oncology's amortization of debt discount), (3) mark-to-market adjustment on financial instruments (which include preferred stock warrants and derivatives) and (4) loss on early debt extinguishment. Non-GAAP financial measures used by ALX Oncology may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies.
Chief Financial Officer, ALX Oncology
(650) 466-7125 Ext. 113