ALX Oncology Reports First Quarter 2022 Financial Results and Provides Clinical Development and Operational Highlights
May 09 2022 - 4:01PM
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 first quarter ended March 31, 2022 and provided clinical
development and operational highlights.
“Throughout the first quarter, we continued to
realize significant progress advancing our lead program,
evorpacept, through multiple clinical trials,” said Jaume Pons,
Ph.D., Founder, President and Chief Executive Officer of ALX
Oncology. “Our highlights include dosing the first patient in
ASPEN-06, our Phase 2/3 study testing evorpacept in combination
with ramucirumab, trastuzumab, and paclitaxel for the treatment of
patients with HER2-positive gastric cancer or gastroesophageal
junction (“GEJ”) cancer and the U.S. Food and Drug Administration
(“FDA”) granting Orphan Drug Designation (“ODD”) to evorpacept for
the treatment of patients with gastric/GEJ cancer.”
“Looking ahead, we are excited for clinical
milestones by year-end including the expected dose optimization
readout of a Phase 1b clinical trial of evorpacept in combination
with azacitidine in patients with myelodysplastic syndromes (“MDS”)
(ASPEN-02) and updates on our Phase 1/2 collaboration with
Zymeworks in evaluating the combination of evorpacept and
zanidatamab in patients with HER2-positive breast cancer and other
solid tumors,” Dr. Pons continued.
Recent Clinical Developments for Evorpacept
- Initiation
of a Phase 2/3 Study of Evorpacept for the Treatment of Patients
with Advanced Gastric or Gastroesophageal Junction Cancer
(ASPEN-06)
- In March 2022, the
first patient was dosed in the Phase 2/3 ASPEN-06 study evaluating
the combination of evorpacept, a next generation CD47 blocker, 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/GEJ cancer.
- ASPEN-06
(NCT05002127) is a randomized Phase 2 (open-label) / Phase 3
(double-blind), international, multi-center study to evaluate the
efficacy of evorpacept in combination with ramucirumab,
trastuzumab, and paclitaxel for the treatment of patients whose
tumors have progressed following treatment with HER2-targeted
therapy and chemotherapy. Approximately 450 adult patients will be
enrolled in the study across both phases.
- FDA
Granted ODD for Evorpacept for the Treatment of Patients with
Gastric/GEJ Cancer
- In January 2022,
ALX Oncology announced that the FDA granted ODD to evorpacept, a
next-generation CD47 blocker, for the treatment of patients with
gastric/GEJ cancer.
Recent Corporate Updates
- Appointed
Itziar Canamasas, Ph.D., to its Board of Directors
- In April 2022, ALX
Oncology announced the appointment of Itziar Canamasas, Ph.D., to
its Board of Directors (the “Board”). With more than 20 years of
biopharmaceutical industry experience, Dr. Canamasas brings
expertise in driving business growth and operational
excellence.
First Quarter 2022 Financial Results:
- Cash, Cash
Equivalents and Investments: Cash, cash equivalents and
investments as of March 31, 2022 were $341.7 million. ALX Oncology
believes its cash, cash equivalents and investments are sufficient
to fund planned operations through mid-2024.
- Research
and Development (“R&D”) Expenses: R&D
expenses consist primarily of pre-clinical, clinical and
manufacturing expenses related to the development of ALX Oncology’s
current lead product candidate, evorpacept, and R&D
employee-related expenses. These expenses for the three months
ended March 31, 2022, were $17.1 million, compared to $9.8 million
for the prior-year period. The increase in expenses during the
three months ended March 31, 2022 compared to the three months
ended March 31, 2021 were primarily attributable to an increase of
$2.6 million in clinical and development costs primarily due to
manufacturing of clinical trial materials to support a higher
number of active clinical trials and future expected patient
enrollment related to the advancement of evorpacept, as well as an
increase of $0.9 million related to the collaboration with Tallac
Therapeutics, Inc., an increase of $2.1 million in personnel
related costs driven by headcount growth, an increase of $1.5
million in stock-based compensation expense due to additional
awards granted since March 31, 2021 and an increase of $0.6 million
in other research costs due primarily to an increase in facility
costs related to the expansion of our new laboratory space.
- General
and Administrative (“G&A”) Expenses: G&A expenses
consist primarily of administrative employee-related expenses,
legal and other professional fees, patent filing and maintenance
fees, and insurance. These expenses for the three months ended
March 31, 2022, were $7.7 million, compared to $4.4 million for the
prior-year period. The expense increases during the three months
ended March 31, 2022 compared to the three months ended
March 31, 2021 were primarily attributable to an increase of
$2.2 million in stock-based compensation expense due to additional
awards granted since March 31, 2021 and an increase of $0.8 million
in other costs primarily driven by an increase in corporate legal
fees, regulatory related filing fees and facility and information
technology costs.
- Net
loss: GAAP net loss was $24.5 million for the first
quarter ended March 31, 2022, or $0.60 per basic and diluted share,
as compared to a net loss of $14.2 million for the first quarter
ended March 31, 2021, or $0.35 per basic and diluted share.
Non-GAAP net loss was $19.0 million for the first quarter ended
March 31, 2022, as compared to a net loss of $12.4 million for the
first quarter ended March 31, 2021. A reconciliation of GAAP to
non-GAAP financial results can be found at the end of this news
release.
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,
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 (unaudited)(in thousands, except share and per
share amounts)
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
17,073 |
|
|
$ |
9,849 |
|
General and administrative |
|
|
7,674 |
|
|
|
4,359 |
|
Total operating expenses |
|
|
24,747 |
|
|
|
14,208 |
|
Loss from operations |
|
|
(24,747 |
) |
|
|
(14,208 |
) |
Interest income |
|
|
225 |
|
|
|
25 |
|
Other income (expense), net |
|
|
(11 |
) |
|
|
(2 |
) |
Net loss |
|
$ |
(24,533 |
) |
|
$ |
(14,185 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.60 |
) |
|
$ |
(0.35 |
) |
Weighted-average shares of common
stock used to compute net loss per shares, basic and diluted |
|
|
40,616,302 |
|
|
|
40,055,435 |
|
|
|
Condensed Consolidated Balance Sheet
Data(unaudited)(in thousands)
|
|
March 31,2022 |
|
|
December 31,2021 |
|
Cash, cash equivalents and investments |
|
$ |
341,705 |
|
|
$ |
363,667 |
|
Total assets |
|
$ |
363,676 |
|
|
$ |
380,183 |
|
Total liabilities |
|
$ |
20,080 |
|
|
$ |
17,134 |
|
Accumulated deficit |
|
$ |
(226,518 |
) |
|
$ |
(201,985 |
) |
Total stockholders’ equity |
|
$ |
343,596 |
|
|
$ |
363,049 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP to Non-GAAP Reconciliation
(unaudited) (in thousands)
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2022 |
|
|
2021 |
|
GAAP net loss, as reported |
|
$ |
(24,533 |
) |
|
$ |
(14,185 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
|
5,501 |
|
|
|
1,800 |
|
Non-GAAP net loss |
|
$ |
(19,032 |
) |
|
$ |
(12,385 |
) |
|
|
|
|
|
|
|
|
|
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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