Full Press Release Details
ALX Oncology Reports Third Quarter 2020 Financial Results and Provides Clinical Development and Operational Highlights
BURLINGAME, Calif., November 12, 2020 -- 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 third quarter ended September 30, 2020, and clinical development and operational highlights.
"We are very pleased to report that during the third quarter we continued to make substantial progress in advancing our next generation anti-CD47 therapeutic, ALX148, in clinical trials in advanced gastric/gastroesophageal junction cancer and head and neck squamous cell cancers, as well as securing a clinical trial collaboration with Merck to study the combination of ALX148 with KEYTRUDA in the setting of first line, metastatic or unresectable, recurrent head and neck squamous cell cancer," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "In addition, subsequent to the third quarter, we announced the first patient has been dosed in the Phase 1/2 ASPEN-02 study evaluating the combination of ALX148 with azacitidine for the treatment of patients with higher-risk myelodysplastic syndromes. We also recently presented further encouraging data for ALX148 from the ASPEN-01 Phase 1b Study at the 35th Annual SITC meeting, including a 64% ORR in advanced gastric cancer patients treated with ALX148 in combination with trastuzumab and the current chemotherapeutic standard of care. We look forward to providing further updates as we continue to advance ALX148 as a potential treatment for a range of solid tumor indications and hematologic malignancies."
Recent Clinical Developments for ALX148
Operational Highlights:
Conference Call on November 16th at 5:00 p.m. EST
New ALX148 Data from the Phase 1b GC Expansion Cohort in ASPEN-01
ALX Oncology will host a conference call on Monday, November 16, 2020 at 5:00 p.m. EST to discuss the updated results from the GC expansion cohort in ASPEN-01, the ALX148 Phase 1b study, which was presented at the SITC 35th Anniversary Annual Meeting. In addition to ALX Oncology's executive management team, Dr. Yung-Jue Bang, Professor Emeritus and former Director of Cancer Research Institute, Seoul National University College of Medicine and Hospital, South Korea, will be featured on the call to discuss the latest ALX148 clinical data in patients with GC.
To access the conference call, please dial (844) 467-7655 (local) or (409) 983-9840 (international) at least 10 minutes prior to the start time and refer to conference ID 4766826. Presentation slides will be available to download under "News & Events" (see "Events") in the Investors section of the ALX Oncology website at www.alxoncology.com.
Third Quarter 2020 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, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 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 ALX148 for the treatment of a range of solid tumor indications and myelodysplastic syndromes. For more information, please visit ALX Oncology's website at www.alxoncology.com.
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 and the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of ALX148. clinical pipeline and the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of ALX148. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Quarterly Report on Form 10-Q, filed with the SEC on November 12, 2020, 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
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Related-party revenue | $ | - | $ | 1,256 | $ | 1,182 | $ | 3,583 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 5,328 | 2,210 | 16,819 | 9,571 | ||||||||||||
| General and administrative | 4,481 | 938 | 9,126 | 2,205 | ||||||||||||
| Cost of services for related-party revenue | - | 1,142 | 1,075 | 3,257 | ||||||||||||
| Total operating expenses | 9,809 | 4,290 | 27,020 | 15,033 | ||||||||||||
| Loss from operations | (9,809 | ) | (3,034 | ) | (25,838 | ) | (11,450 | ) | ||||||||
| Interest expense | (226 | ) | - | (660 | ) | - | ||||||||||
| Other expense, net | (111 | ) | (2 | ) | (409 | ) | (4 | ) | ||||||||
| Loss before income taxes | (10,146 | ) | (3,036 | ) | (26,907 | ) | (11,454 | ) | ||||||||
| Income tax provision | (35 | ) | (8 | ) | (59 | ) | (25 | ) | ||||||||
| Net loss and comprehensive loss | (10,181 | ) | (3,044 | ) | (26,966 | ) | (11,479 | ) | ||||||||
| Cumulative dividends allocated to preferred stockholders | (578 | ) | (1,071 | ) | (5,202 | ) | (2,957 | ) | ||||||||
| Net loss attributable to common stockholders | $ | (10,759 | ) | $ | (4,115 | ) | $ | (32,168 | ) | $ | (14,436 | ) |
Condensed Consolidated Balance Sheet Data
| September 30, 2020 | December 31, 2019 | ||||||||
| Cash and cash equivalents | $ | 259,484 | $ | 9,017 | |||||
| Total assets | $ | 262,449 | $ | 10,676 | |||||
| Total liabilities | $ | 10,433 | $ | 10,952 | |||||
| Convertible preferred stock | $ | - | $ | 70,363 | |||||
| Total stockholders' equity/(deficit) | $ | 252,016 | $ | (70,639 | ) |
GAAP to Non-GAAP Reconciliation
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| GAAP net loss, as reported | $ | (10,181 | ) | $ | (3,044 | ) | $ | (26,966 | ) | $ | (11,479 | ) | ||||
| Adjustments: | ||||||||||||||||
| Stock-based compensation expense | 689 | 86 | 3,693 | 222 | ||||||||||||
| Accretion of term loan | 118 | - | 339 | - | ||||||||||||
| Mark-to-market adjustment on financial instruments | 242 | - | 650 | - | ||||||||||||
| Total adjustments | 1,049 | 86 | 4,682 | 222 | ||||||||||||
| Non-GAAP net loss | $ | (9,132 | ) | $ | (2,958 | ) | $ | (22,284 | ) | $ | (11,257 | ) |
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" is not based on any standardized methodology prescribed by GAAP and represent GAAP net loss adjusted to exclude (1) stock-based compensation expense, (2) debt offering costs (interest expense related to ALX Oncology's term loan offering costs) and (3) mark-to market adjustment on financial instruments (which include preferred stock warrants and derivatives) within our reconciliation of our GAAP to Non-GAAP net loss. 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