Full Press Release Details
ALX Oncology Reports Second Quarter 2021 Financial Results and Provides Clinical Development and Operational Highlights
BURLINGAME, Calif., August 12, 2021 -- 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)
Anticipated Key Milestones for Remainder of 2021
Second 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 (also known as ALX148), 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 malignances, including AML and myelodysplastic syndromes.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. 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 statements include, but are not limited to, statements regarding ALX Oncology's financial condition, results of operations and sufficiency of its cash and cash equivalents to fund its planned operations as well as statements about ALX Oncology's clinical pipeline, including the timing of clinical trial initiations and data releases, and the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of evorpacept.
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 Report on Form 10-K, filed with the SEC on March 18, 2021, and other documents ALX Oncology subsequently 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 | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Related-party revenue | $ | - | $ | 527 | $ | - | $ | 1,182 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 11,213 | 7,663 | 21,062 | 11,491 | ||||||||||||
| General and administrative | 5,086 | 3,172 | 9,445 | 4,645 | ||||||||||||
| Cost of services for related-party revenue | - | 479 | - | 1,075 | ||||||||||||
| Total operating expenses | 16,299 | 11,314 | 30,507 | 17,211 | ||||||||||||
| Loss from operations | (16,299 | ) | (10,787 | ) | (30,507 | ) | (16,029 | ) | ||||||||
| Interest expense | (3 | ) | (219 | ) | (6 | ) | (434 | ) | ||||||||
| Other income (expense), net | 28 | (305 | ) | 54 | (298 | ) | ||||||||||
| Loss before income taxes | (16,274 | ) | (11,311 | ) | (30,459 | ) | (16,761 | ) | ||||||||
| Income tax provision | - | (20 | ) | - | (24 | ) | ||||||||||
| Net loss and comprehensive loss | (16,274 | ) | (11,331 | ) | (30,459 | ) | (16,785 | ) | ||||||||
| Cumulative dividends allocated to preferred stockholders | - | (2,641 | ) | - | (4,624 | ) | ||||||||||
| Net loss attributable to common stockholders | $ | (16,274 | ) | $ | (13,972 | ) | $ | (30,459 | ) | $ | (21,409 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.40 | ) | $ | (4.41 | ) | $ | (0.76 | ) | $ | (6.78 | ) | ||||
| Weighted-average shares of common stock used to compute net loss per share attributable to common stockholders, basic and diluted | 40,247,110 | 3,164,707 | 40,151,802 | 3,157,387 |
Condensed Consolidated Balance Sheet Data
| June 30, 2021 | December 31, 2020 | |||||||
| Cash and cash equivalents | $ | 409,964 | $ | 434,219 | ||||
| Total assets | $ | 421,289 | $ | 436,054 | ||||
| Total liabilities | $ | 16,275 | $ | 6,209 | ||||
| Total stockholders' equity | $ | 405,014 | $ | 429,845 |
GAAP to Non-GAAP Reconciliation
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| GAAP net loss attributable to common stockholders, as reported | $ | (16,274 | ) | $ | (13,972 | ) | $ | (30,459 | ) | $ | (21,409 | ) | ||||
| Adjustments: | ||||||||||||||||
| Stock-based compensation expense | 2,237 | 2,853 | 4,037 | 3,004 | ||||||||||||
| Accretion of term loan | - | 113 | - | 221 | ||||||||||||
| Mark-to-market adjustment on financial instruments | - | 308 | - | 408 | ||||||||||||
| Total adjustments | 2,237 | 3,274 | 4,037 | 3,633 | ||||||||||||
| Non-GAAP net loss attributable to common stockholders | $ | (14,037 | ) | $ | (10,698 | ) | $ | (26,422 | ) | $ | (17,776 | ) |
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) and (3) mark-to-market adjustment on financial instruments (which include preferred stock warrants and derivatives). 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