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Exhibit 99.1 |
ALX Oncology Reports Second Quarter 2022 Financial Results and Provides Clinical Development and Operational Highlights
SOUTH SAN FRANCISCO, Calif., August 8, 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 second quarter ended June 30, 2022 and provided clinical development and operational highlights.
“The second quarter of 2022 was marked by substantial progress advancing our lead program, evorpacept, through multiple clinical trials,” said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. “Notable accomplishments included the U.S. Food and Drug Administration (“FDA”) granting Fast Track designation to evorpacept for the first-line treatment of adult patients with PD-L1 positive advanced head and neck squamous cell carcinoma (“HNSCC”) in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, and Orphan Drug Designation (“ODD”) to evorpacept for the treatment of patients with acute myeloid leukemia (“AML”).”
“We continue to expand our clinical development efforts with the introduction of a new clinical study, ASPEN-07, a Phase 1 trial of evorpacept for the treatment of patients with urothelial carcinoma (“UC”) and anticipate initiation in the fourth quarter of 2022. We are continuing enrollment in ASPEN-03 and ASPEN-04, two distinct Phase 2 studies for the treatment of patients with advanced HNSCC. In addition, we continue to advance ASPEN-06, our Phase 2/3 study testing evorpacept and CYRAMZA® (ramucirumab), Eli Lilly and Company’s anti-VEGFR2 antibody, added to trastuzumab and paclitaxel for the treatment of patients with HER2-positive gastric cancer or gastroesophageal junction (“GEJ”) cancer,” Dr. Pons continued.
Recent Clinical Developments for Evorpacept
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Second Quarter 2022 Financial Results:
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About ALX Oncology
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.
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.
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except share and per share amounts)
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Three Months Ended |
|
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Six Months Ended |
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|
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June 30, |
|
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June 30, |
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||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
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||||
Research and development |
|
$ |
26,748 |
|
|
$ |
11,213 |
|
|
$ |
43,821 |
|
|
$ |
21,062 |
|
General and administrative |
|
|
7,041 |
|
|
|
5,086 |
|
|
|
14,715 |
|
|
|
9,445 |
|
Total operating expenses |
|
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33,789 |
|
|
|
16,299 |
|
|
|
58,536 |
|
|
|
30,507 |
|
Loss from operations |
|
|
(33,789 |
) |
|
|
(16,299 |
) |
|
|
(58,536 |
) |
|
|
(30,507 |
) |
Interest income |
|
|
876 |
|
|
|
23 |
|
|
|
1,101 |
|
|
|
48 |
|
Other income (expense), net |
|
|
(7 |
) |
|
|
2 |
|
|
|
(18 |
) |
|
|
— |
|
Net loss |
|
$ |
(32,920 |
) |
|
$ |
(16,274 |
) |
|
$ |
(57,453 |
) |
|
$ |
(30,459 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.81 |
) |
|
$ |
(0.40 |
) |
|
$ |
(1.41 |
) |
|
$ |
(0.76 |
) |
Weighted-average shares of common stock used to |
|
|
40,687,751 |
|
|
|
40,247,110 |
|
|
|
40,652,224 |
|
|
|
40,151,802 |
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Condensed Consolidated Balance Sheet Data
(unaudited)
(in thousands)
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2022 |
|
|
2021 |
|
||
Cash, cash equivalents and investments |
|
$ |
324,226 |
|
|
$ |
363,667 |
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Total assets |
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$ |
346,018 |
|
|
$ |
380,183 |
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Total liabilities |
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$ |
29,699 |
|
|
$ |
17,134 |
|
Accumulated deficit |
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$ |
(259,438 |
) |
|
$ |
(201,985 |
) |
Total stockholders’ equity |
|
$ |
316,319 |
|
|
$ |
363,049 |
|
GAAP to Non-GAAP Reconciliation
(unaudited)
(in thousands)
|
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Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
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June 30, |
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June 30, |
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||||||||||
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|
2022 |
|
|
2021 |
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|
2022 |
|
|
2021 |
|
||||
GAAP net loss, as reported |
|
$ |
(32,920 |
) |
|
$ |
(16,274 |
) |
|
$ |
(57,453 |
) |
|
$ |
(30,459 |
) |
Adjustments: |
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|
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|
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Stock-based compensation expense |
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5,836 |
|
|
|
2,237 |
|
|
|
11,337 |
|
|
|
4,037 |
|
Non-GAAP net loss |
|
$ |
(27,084 |
) |
|
$ |
(14,037 |
) |
|
$ |
(46,116 |
) |
|
$ |
(26,422 |
) |
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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 attributable to common stockholders” 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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