ALX Oncology Reports First Quarter 2023 Financial Results and Provides Clinical Development and Operational Highlights
May 11 2023 - 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, 2023 and provided clinical
development and operational highlights.
“In the first quarter of 2023, we continued to make significant
progress in advancing our lead program, evorpacept, through new
collaborations and clinical trial starts,” said Dr. Jaume Pons,
Founder, President and Chief Executive Officer of ALX Oncology.
“This included our recently announced clinical trial collaboration
with Sanofi to evaluate evorpacept in combination with SARCLISA® in
patients with multiple myeloma, and the initiation of three new
clinical studies. These studies encompass our initiation of a Phase
1 trial in urothelial cancer in combination with PADCEV®, the
initiation of a Phase 1 I-SPY-PI TRIAL for the treatment of
patients with unresectable or metastatic HER-positive and HER2-low
breast cancer in combination with ENHERTU® in partnership with
Quantum Leap Healthcare Collaborative (“Quantum Leap”), and the
recently announced initiation of a Phase 2 investigator-sponsored
trial of evorpacept, in combination with liposomal doxorubicin and
KEYTRUDA® in patients with recurrent platinum-resistant ovarian
cancer.”
Dr. Pons added, “We look forward to important readouts in the
second half of 2023 from ASPEN-06, a randomized Phase 2 trial of
evorpacept in combination with trastuzumab, paclitaxel and CYRAMZA®
(ramucirumab) for the treatment of patients with HER2-positive
gastric/gastroesophageal junction cancer, and from ASPEN-02, a
Phase 1b clinical trial of evorpacept in combination with
azacitidine in patients with myelodysplastic syndromes.
Additionally, in collaboration with Tallac Therapeutics, we remain
on track to file an Investigational New Drug application in the
first half of this year for ALTA-002, a SIRPa Toll-like receptor
agonist antibody conjugate, that will broaden our immuno-oncology
pipeline beyond evorpacept.”
Recent Clinical Developments for Evorpacept
- First patient dosed in Phase 2 investigator-sponsored
trial of evorpacept in combination with KEYTRUDA in patients with
ovarian cancer.
- In May 2023, we announced the initiation of a Phase 2
investigator-sponsored trial of evorpacept in combination with
liposomal doxorubicin and KEYTRUDA (pembrolizumab) in patients with
recurrent platinum-resistant ovarian cancer at the UPMC Hillman
Cancer Center. This is an open-label, single-arm Phase 2 clinical
trial. The study is being led by Haider Mahdi, M.D., M.P.H.,
Assistant Professor, Department of Obstetrics, Gynecology and
Reproductive Sciences, The University of Pittsburgh and UPMC
Magee-Womens Research Institute.
- Announced clinical trial collaboration with Sanofi to
evaluate evorpacept in combination with SARCLISA in patients with
multiple myeloma.
- In April 2023, we entered into a clinical trial collaboration
and supply agreement with Sanofi to evaluate evorpacept and
SARCLISA (isatuximab-irfc), Sanofi’s monoclonal antibody that
targets a specific epitope on the CD38 receptor on multiple myeloma
cells, for the treatment of patients with relapsed or refractory
multiple myeloma (“RRMM”). Under the terms of the agreement, Sanofi
will conduct a Phase 1/2 study to evaluate the safety, efficacy,
pharmacokinetics and biomarker data of evorpacept in combination
with SARCLISA and dexamethasone in patients with RRMM.
- First patient dosed in I-SPY-PI TRIAL evaluating
evorpacept in combination with ENHERTU, a HER2 directed
antibody-drug conjugate (“ADC”), in breast cancer.
- In March 2023, we announced the dosing of the first patient in
the I-SPY-PI TRIAL for the treatment of patients with breast
cancer. Sponsored by Quantum Leap, this Phase 1 (open label),
multi-center study arm is investigating evorpacept in combination
with ENHERTU (fam-trastuzumab deruxtecan-nxki) to determine the
safety, tolerability and efficacy of this drug combination in
patients with unresectable or metastatic HER2-positive and HER2-low
breast cancer.
- First patient dosed in ASPEN-07 study evaluating
evorpacept in combination with PADCEV, an ADC, in patients with
urothelial cancer (“UC”).
- In February 2023, we announced the first patient was dosed in
the Phase 1 ASPEN-07 study evaluating evorpacept in combination
with PADCEV (enfortumab vedotin-ejfv), an ADC, in patients with UC.
ASPEN-07 is a Phase 1, open-label, multi-center study to evaluate
the safety, tolerability, pharmacokinetics and pharmacodynamics of
evorpacept in combination with PADCEV in subjects with unresectable
locally advanced or metastatic UC.
First Quarter 2023 Financial Results:
- Cash, Cash Equivalents and Investments: Cash,
cash equivalents and investments as of March 31, 2023 were $256.2
million. ALX Oncology believes its cash, cash equivalents,
investments along with the ability to draw down an additional $40
million of its term loan are sufficient to fund planned operations
through mid-2025.
- Research and Development (“R&D”) Expenses:
R&D expenses consist primarily of pre-clinical, clinical and
manufacturing expenses related to the development of the Company’s
current lead product candidate, evorpacept, and R&D
employee-related expenses. These expenses for the three months
ended March 31, 2023 were $24.8 million, compared to $17.1 million
for the prior-year period. The increase was primarily due to an
increase of $5.3 million in clinical costs from an increase in the
number of active trials and patient enrollment as well as
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, an increase of
$1.5 million in personnel and related costs primarily driven by
headcount growth, and an increase of $1.1 million in stock-based
compensation expense due to additional awards granted since March
31, 2022 offset by a decrease of $0.6 million related to the Tallac
Collaboration for costs related to the IND filing planned for 2023
in which the primary work was completed in 2022.
- 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, 2023
were $7.4 million, compared to $7.7 million for the prior-year
period. The small decrease year over year was primarily
attributable to reduced stock-based compensation expense primarily
due to forfeited stock options during the quarter and a decrease in
other general and administrative costs due primarily to corporate
legal and patent costs.
- Net loss: GAAP net loss was $30.2 million for
the first quarter ended March 31, 2023, or $0.74 per basic and
diluted share, as compared to GAAP net loss of $24.5 million for
the first quarter ended March 31, 2022, or $0.60 per basic and
diluted share. Non-GAAP net loss was $23.8 million for the first
quarter ended March 31, 2023, as compared to a non-GAAP net loss of
$19.0 million for the first quarter ended March 31, 2022. A
reconciliation of GAAP to non-GAAP financial results can be found
at the end of this press 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.
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, |
|
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
24,763 |
|
|
$ |
17,073 |
|
General and administrative |
|
|
7,440 |
|
|
|
7,674 |
|
Total operating expenses |
|
|
32,203 |
|
|
|
24,747 |
|
Loss
from operations |
|
|
(32,203 |
) |
|
|
(24,747 |
) |
Interest income |
|
|
2,311 |
|
|
|
225 |
|
Interest expense |
|
|
(387 |
) |
|
|
(3 |
) |
Other income (expense), net |
|
|
95 |
|
|
|
(8 |
) |
Net
loss |
|
$ |
(30,184 |
) |
|
$ |
(24,533 |
) |
Net loss
per share, basic and diluted |
|
$ |
(0.74 |
) |
|
$ |
(0.60 |
) |
Weighted-average shares of common stock used to
compute net loss per shares, basic and diluted |
|
|
40,862,513 |
|
|
|
40,616,302 |
|
Condensed Consolidated Balance Sheet Data |
(unaudited) |
(in thousands) |
|
|
March 31, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
Cash, cash equivalents and investments |
|
$ |
256,164 |
|
|
$ |
282,906 |
|
Total
assets |
|
$ |
278,138 |
|
|
$ |
306,489 |
|
Total
liabilities |
|
$ |
37,750 |
|
|
$ |
43,025 |
|
Accumulated deficit |
|
$ |
(355,651 |
) |
|
$ |
(325,467 |
) |
Total
stockholders’ equity |
|
$ |
240,388 |
|
|
$ |
263,464 |
|
GAAP to Non-GAAP Reconciliation |
(unaudited) |
(in thousands) |
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2023 |
|
|
2022 |
|
GAAP net loss, as reported |
|
$ |
(30,184 |
) |
|
$ |
(24,533 |
) |
Adjustments: |
|
|
|
|
|
|
Stock-based compensation expense |
|
|
6,351 |
|
|
|
5,501 |
|
Accretion of term loan discount and issuance costs |
|
|
61 |
|
|
|
— |
|
Total adjustments |
|
|
6,412 |
|
|
|
5,501 |
|
Non-GAAP
net loss |
|
$ |
(23,772 |
) |
|
$ |
(19,032 |
) |
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 and accretion of term loan
discount and issuance costs. 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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