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Exhibit 99.1 |
ALX Oncology Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Clinical Development and Operational Highlights and Upcoming Milestones
SOUTH SAN FRANCISCO, Calif., March 9, 2023 (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, 2022 and provided clinical development and operational highlights.
“2022 was a productive year for us, with numerous clinical and corporate development accomplishments highlighted by the advancement of our lead program, evorpacept, for the treatment of multiple solid tumor indications and hematological malignancies. We also expanded evorpacept into new indications and combinations,” said Dr Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. “These included a Phase 1 trial in urothelial cancer (“UC”) in combination with PADCEV®, and a new investigational treatment arm in the I-SPY-P1 trial for the treatment of patients with unresectable or metastatic HER2-positive and HER2-low breast cancer in combination with ENHERTU® in partnership with Quantum Leap Healthcare Collaborative.”
Dr. Pons added, “2023 is expected to be an eventful year for ALX Oncology with the presentation of data from ASPEN-06, a randomized Phase 2 trial of evorpacept in combination with trastuzumab, ramucirumab and paclitaxel for the treatment of patients with HER2-positive gastric/gastroesophageal junction (“GEJ”) cancer in the second half of 2023, and the presentation of dose optimization results from ASPEN-02, a Phase 1b clinical trial of evorpacept in combination with azacitidine in patients with myelodysplastic syndromes (“MDS”) in the second half of 2023. Additionally, we are on track to file an Investigational New Drug (“IND”) application in the first half of 2023, in collaboration with Tallac Therapeutics, for ALTA-002 that will further expand our clinical pipeline beyond evorpacept.”
Anticipated Key Milestones in 2023
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Recent Clinical Developments for Evorpacept
Recent Corporate Updates
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Full Year and Fourth Quarter 2022 Financial Results:
About ALX Oncology
ALX Oncology is a 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 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 commercial anti-cancer agents. ALX Oncology intends to continue clinical development of evorpacept for the treatment of multiple solid tumor indications and hematologic malignancies.
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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.
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ALX ONCOLOGY HOLDINGS INC.
Consolidated Statements of Operations
(unaudited for the three months ended December 31, 2022 and 2021)
(in thousands, except share and per share amounts)
|
|
Three Months Ended |
|
|
Year Ended |
|
||||||||||
|
|
December 31, |
|
|
December 31, |
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||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
25,197 |
|
|
$ |
20,894 |
|
|
$ |
98,400 |
|
|
$ |
60,170 |
|
General and administrative |
|
|
7,022 |
|
|
|
7,578 |
|
|
|
29,036 |
|
|
|
23,385 |
|
Total operating expenses |
|
|
32,219 |
|
|
|
28,472 |
|
|
|
127,436 |
|
|
|
83,555 |
|
Loss from operations |
|
|
(32,219 |
) |
|
|
(28,472 |
) |
|
|
(127,436 |
) |
|
|
(83,555 |
) |
Interest income |
|
|
1,807 |
|
|
|
21 |
|
|
|
4,278 |
|
|
|
91 |
|
Other expense, net |
|
|
(233 |
) |
|
|
(8 |
) |
|
|
(260 |
) |
|
|
(20 |
) |
Loss before income taxes |
|
|
(30,645 |
) |
|
|
(28,459 |
) |
|
|
(123,418 |
) |
|
|
(83,484 |
) |
Income tax (provision) benefit |
|
|
(64 |
) |
|
|
21 |
|
|
|
(64 |
) |
|
|
21 |
|
Net loss |
|
$ |
(30,709 |
) |
|
$ |
(28,438 |
) |
|
$ |
(123,482 |
) |
|
$ |
(83,463 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.75 |
) |
|
$ |
(0.70 |
) |
|
$ |
(3.03 |
) |
|
$ |
(2.07 |
) |
Weighted-average shares of common stock used to |
|
|
40,755,520 |
|
|
|
40,527,314 |
|
|
|
40,699,612 |
|
|
|
40,308,050 |
|
Consolidated Balance Sheet Data
(in thousands)
|
|
December 31, |
|
|||||
|
|
2022 |
|
|
2021 |
|
||
Cash, cash equivalents and investments |
|
$ |
282,906 |
|
|
$ |
363,667 |
|
Total assets |
|
$ |
306,489 |
|
|
$ |
380,183 |
|
Total liabilities |
|
$ |
43,025 |
|
|
$ |
17,134 |
|
Accumulated deficit |
|
$ |
(325,467 |
) |
|
$ |
(201,985 |
) |
Total stockholders’ equity |
|
$ |
263,464 |
|
|
$ |
363,049 |
|
GAAP to Non-GAAP Reconciliation
(unaudited)
(in thousands)
|
|
Three Months Ended |
|
|
Year Ended |
|
||||||||||
|
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December 31, |
|
|
December 31, |
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||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
GAAP net loss, as reported |
|
$ |
(30,709 |
) |
|
$ |
(28,438 |
) |
|
$ |
(123,482 |
) |
|
$ |
(83,463 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Stock-based compensation expense |
|
|
6,295 |
|
|
|
5,686 |
|
|
|
23,839 |
|
|
|
13,914 |
|
Accretion of term loan |
|
|
44 |
|
|
|
— |
|
|
|
44 |
|
|
|
— |
|
Total adjustments |
|
|
6,339 |
|
|
|
5,686 |
|
|
|
23,883 |
|
|
|
13,914 |
|
Non-GAAP net loss |
|
$ |
(24,370 |
) |
|
$ |
(22,752 |
) |
|
$ |
(99,599 |
) |
|
$ |
(69,549 |
) |
5
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 SEC 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 stock-based compensation expense. 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.
Investor Contact:
Peter Garcia
Chief Financial Officer, ALX Oncology
(650) 466-7125 Ext. 113
peter@alxoncology.com
Argot Partners
(212) 600-1902
alxoncology@argotpartners.com
Media Contact:
Karen Sharma
MacDougall
(781) 235-3060
alx@macbiocom.com
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