ALX Oncology Reports Third Quarter 2021 Financial Results and Provides Clinical Development and Operational Highlights
November 11 2021 - 4:05PM
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, 2021 and provided
clinical development and operational highlights.
“The third quarter was marked by substantial
progress advancing our lead program, evorpacept (ALX148) through
multiple clinical trials,” said Jaume Pons, Ph.D., Founder,
President and Chief Executive Officer of ALX Oncology. “Highlights
include reporting new data at the ESMO conference from ASPEN-01,
our Phase 1b trial testing evorpacept with trastuzumab, ramucirumab
and paclitaxel in >2nd line HER2-positive gastric or
gastroesophageal junction cancer. We also dosed the first patient
in ASPEN-04, our Phase 2 trial testing evorpacept in combination
with pembrolizumab and chemotherapy for 1st line patients with
unresectable or metastatic squamous cell carcinoma of the head and
neck. Subsequent to the quarter end, we dosed the first patients in
our ASPEN-05 Phase 1/2 study in acute myeloid leukemia and in our
Phase 1/2 collaboration with Zymeworks, which is evaluating the
combination of evorpacept and zanidatamab in patients with
HER2-positive breast cancer and other solid tumors. On the business
development front, in October, we acquired privately-held
ScalmiBio, giving us full access to their proprietary SHIELD
platform for conditional activation of antibodies in the tumor
microenvironment and proprietary cytotoxic payloads for
antibody-drug conjugates.”
“Looking ahead, we expect a data-filled fourth
quarter, which will include four poster presentations at the
upcoming SITC conference, including data from ASPEN-01, which we
presented on November 9, the trial designs from both our Phase 2
head and neck cancer studies in collaboration with Merck (ASPEN-03
and ASPEN-04) and preclinical data for ALTA-002, a first in class
SIRPa-directed TLR9 agonist antibody conjugate being developed in
collaboration with Tallac Therapeutics,” Dr. Pons continued. “Later
this quarter, we expect to report additional Phase 1b data from
ASPEN-02 in myelodysplastic syndromes, and the initiation of
ASPEN-06, our randomized Phase 2 trial in second line gastric
cancer,” Dr. Pons continued.
Recent Clinical Developments for Evorpacept
(ALX148)
- Data for
Phase 1b ASPEN-01 Study Presented at Society for Immunotherapy of
Cancer’s 36th Anniversary Annual Meeting
-
In November 2021, announced updated results from ASPEN-01, the
evorpacept phase 1b study, evaluating patients with solid tumor
malignancies at the Society for Immunotherapy of Cancer’s 36th
Anniversary Annual Meeting (abstract 498). ALX Oncology reported
updated results from the gastric/gastroesophageal junction cancer
patient cohort receiving evorpacept plus trastuzumab plus
chemotherapy, and from the head and neck squamous cell carcinoma
patient cohort receiving evorpacept plus pembrolizumab with and
without chemotherapy. Data showed robust and durable responses with
emerging signs of clinical benefit in survival-based endpoints in
patients with advanced solid tumors. All data reflected response
evaluable patients as of September 1, 2021.
- Abstract Data for Phase 1/2
ASPEN-02 Study in Myelodysplastic Syndromes
Released as part of the 63rd
American Society of Hematology (“ASH”) Annual
Meeting
- In
November 2021, presented an ASH abstract and updated data
evaluating evorpacept in combination with azacitidine for the
treatment of myelodysplastic syndromes (“MDS”). Among the 5 newly
diagnosed subjects evaluable for response (all with TP53 mutation),
there were 2 subjects with cytogenetic response who met criteria
for complete response subsequent to the date of this abstract, 1
subject with a best response of marrow complete response with
hematologic improvement, and 1 subject each with stable disease and
progressive disease. No dose-limiting toxicities were observed in
any cohort and no maximum tolerated dose was reached. Additional
results will be presented in a poster at the ASH meeting to be held
December 11-14 conference (Session 637: Poster II).
- First Patient Dosed in Phase
1/2 ASPEN-05 Study
- In October 2021,
dosed first patient in the Phase 1/2 ASPEN-05 study evaluating the
combination of evorpacept with venetoclax and azacitidine for the
treatment of patients with AML. The Phase 1 portion will
characterize the dose of evorpacept in combination with venetoclax
and azacitidine for the treatment of patients with
relapsed/refractory AML and previously untreated AML who are not
candidates for intensive induction therapy.
- First Patient Dosed in Phase
1b/2 Clinical Trial of Zanidatamab and Evorpacept in Patients with
Advanced HER2-Expressing Breast Cancer and Other Solid
Tumors
- In October 2021,
Zymeworks and ALX Oncology dosed the first patient in an
open-label, multi-center Phase 1b/2 clinical trial to evaluate the
safety and efficacy of zanidatamab, Zymeworks’ lead HER2-targeted
bispecific antibody, in combination with evorpacept in patients
with advanced HER2-positive breast cancer, HER2-low breast cancer
and additional non-breast HER2-expressing solid tumors.
- Initiation of a Phase 1/2
Investigator-Sponsored Trial of Evorpacept in Patients with
Indolent and Aggressive Non-Hodgkin Lymphoma (“NHL”)
- In September 2021,
initiated a Phase 1/2 investigator-sponsored trial of evorpacept in
combination with rituximab and lenalidomide for the treatment of
patients with indolent and aggressive NHL. The study is being led
by Dr. Paolo Strati at the University of Texas M.D. Anderson Cancer
Center, one of the largest multidisciplinary programs in the U.S.
for treating NHL.
Recent Corporate Updates
- Acquisition of ScalmiBio
Expands ALX Oncology’s Immuno-Oncology Pipeline
- In October 2021,
ALX Oncology acquired ScalmiBio thus further expanding its pipeline
with plans to develop novel antibody-drug conjugates (“ADCs”) based
on ScalmiBio’s SHIELD platform. These new molecules will be
designed to address unmet cancer patient needs as stand-alone
therapeutics and in combination with evorpacept. ScalmiBio’s SHIELD
technology is designed to minimize interaction of an antibody
therapeutic with normal tissue and maximize its target binding
capability within the tumor microenvironment. ScalmiBio’s
conditional activation technology aims to increase the therapeutic
index by minimizing dose-limiting toxicities of existing checkpoint
inhibitors and other targeted anti-cancer biologics as well as
enabling the design of ADCs with higher drug-to-antibody ratios for
improved anti-cancer activity.
- Under the terms of
the share purchase agreement, ALX Oncology made an initial payment
to the stockholders of ScalmiBio at closing on October 4, 2021 of
approximately $4.5 million in cash, net of certain expenses and
adjustments, and will make an additional payment of $2.0 million in
cash at the one-year anniversary of the transaction subject to
certain conditions. In addition, ALX Oncology has agreed to pay
certain milestones based on the clinical development of the
acquired ScalmiBio technology and a low single digit royalty on net
sales of any products developed from the ScalmiBio acquired
technology for a defined term.
Third Quarter 2021 Financial Results:
- Cash and
Cash Equivalents: Cash and cash equivalents as of
September 30, 2021 were $385.1 million. ALX Oncology believes its
cash and cash equivalents is sufficient to fund planned operations
through 2024.
- Net
Loss: Generally accepted accounting principles (GAAP) net
loss attributable to common stockholders was $24.6 million, or
$0.61 per basic and diluted share and $10.8 million, or $0.36 per
basic and diluted share for the three months ended September 30,
2021, and 2020, respectively. Non-GAAP net loss attributable to
common stockholders was $20.4 million for the three months ended
September 30, 2021, as compared to $9.7 million for the three
months ended September 30, 2020. A reconciliation of GAAP to
non-GAAP financial results can be found at the end of this news
release.
- Research
and Development (“R&D”) Expenses: R&D expenses
consist primarily of pre-clinical, clinical and manufacturing
expenses related to the development of our current lead product
candidate, evorpacept. These expenses for the three months ended
September 30, 2021, were $18.2 million compared to $5.3 million for
the prior-year period. The increase of $12.9 million was primarily
attributable to an increase of $10.0 million in clinical and
development costs due to $8.7 million higher expenses associated
with increased clinical costs mainly associated with higher number
of active clinical trials and increased patient enrollment and
other research costs in advancement of our current lead product
candidate, evorpacept, $0.8 million related to collaborations, of
which $0.6 million was related to the Tallac Collaboration, and
$0.3 million related regulatory consulting expenses; an increase of
$1.9 million in stock-based compensation expense mainly due to
additional stock option awards granted in 2021 at higher fair
values and negative stock-based compensation expense due to a
reduction recorded in corresponding prior period; and an increase
of $0.9 million in personnel expense driven by headcount
growth.
- 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
September 30, 2021, were $6.4 million compared to $4.5 million for
the prior-year period. The increase of $1.9 million was primarily
attributable to an increase of $1.6 million in stock-based
compensation driven by additional stock option awards granted in
2021 at higher fair values, with the remaining increase due to
other general and administrative costs including corporate legal
fees, general business insurance fees, and SOX 404 compliance
expenses.
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 (also known as
ALX148), 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 malignances, including acute myeloid leukemia and
myelodysplastic syndromes.
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, including the timing of clinical trial
initiations and data releases, and the expectations regarding the
beneficial characteristics, safety, efficacy and therapeutic
effects of evorpacept. 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 Report on Form
10-K, filed with the SEC on March 18, 2021, 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(unaudited)(in thousands,
except share and per share amounts)
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
September 30, |
|
|
September 30, |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Related-party revenue |
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
1,182 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
18,214 |
|
|
|
5,328 |
|
|
|
39,276 |
|
|
|
16,819 |
|
General and administrative |
|
6,362 |
|
|
|
4,481 |
|
|
|
15,807 |
|
|
|
9,126 |
|
Cost of services for related-party revenue |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,075 |
|
Total operating expenses |
|
24,576 |
|
|
|
9,809 |
|
|
|
55,083 |
|
|
|
27,020 |
|
Loss from operations |
|
(24,576 |
) |
|
|
(9,809 |
) |
|
|
(55,083 |
) |
|
|
(25,838 |
) |
Interest expense |
|
(4 |
) |
|
|
(226 |
) |
|
|
(10 |
) |
|
|
(660 |
) |
Other income (expense), net |
|
14 |
|
|
|
(111 |
) |
|
|
68 |
|
|
|
(409 |
) |
Loss before income taxes |
|
(24,566 |
) |
|
|
(10,146 |
) |
|
|
(55,025 |
) |
|
|
(26,907 |
) |
Income tax provision |
|
— |
|
|
|
(35 |
) |
|
|
— |
|
|
|
(59 |
) |
Net loss and comprehensive
loss |
|
(24,566 |
) |
|
|
(10,181 |
) |
|
|
(55,025 |
) |
|
|
(26,966 |
) |
Cumulative dividends allocated to
preferred stockholders |
|
— |
|
|
|
(578 |
) |
|
|
— |
|
|
|
(5,202 |
) |
Net loss attributable to common
stockholders |
$ |
(24,566 |
) |
|
$ |
(10,759 |
) |
|
$ |
(55,025 |
) |
|
$ |
(32,168 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
$ |
(0.61 |
) |
|
$ |
(0.36 |
) |
|
$ |
(1.37 |
) |
|
$ |
(2.67 |
) |
Weighted-average shares of common
stock used to compute net loss per share attributable to common
stockholders, basic and diluted |
|
40,396,188 |
|
|
|
29,664,122 |
|
|
|
40,234,159 |
|
|
|
12,052,876 |
|
|
|
Condensed Consolidated Balance Sheet
Data(unaudited)(in thousands)
|
September 30,2021 |
|
|
December 31,2020 |
|
Cash and cash equivalents |
$ |
385,149 |
|
|
$ |
434,219 |
|
Total assets |
$ |
399,728 |
|
|
$ |
436,054 |
|
Total liabilities |
$ |
14,556 |
|
|
$ |
6,209 |
|
Total stockholders’ equity |
$ |
385,172 |
|
|
$ |
429,845 |
|
|
|
|
|
|
|
|
|
GAAP to Non-GAAP Reconciliation
(unaudited) (in thousands)
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
September 30, |
|
|
September 30, |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
GAAP net loss attributable to common stockholders, as reported |
$ |
(24,566 |
) |
|
$ |
(10,759 |
) |
|
$ |
(55,025 |
) |
|
$ |
(32,168 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
4,191 |
|
|
|
689 |
|
|
|
8,228 |
|
|
|
3,693 |
|
Accretion of term loan |
|
— |
|
|
|
118 |
|
|
|
— |
|
|
|
339 |
|
Mark-to-market adjustment on financial instruments |
|
— |
|
|
|
242 |
|
|
|
— |
|
|
|
650 |
|
Total adjustments |
|
4,191 |
|
|
|
1,049 |
|
|
|
8,228 |
|
|
|
4,682 |
|
Non-GAAP net loss attributable to
common stockholders |
$ |
(20,375 |
) |
|
$ |
(9,710 |
) |
|
$ |
(46,797 |
) |
|
$ |
(27,486 |
) |
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 attributable to common
stockholders” is not based on any standardized methodology
prescribed by GAAP and represent GAAP net loss adjusted to exclude
(1) stock-based compensation expense, (2) accretion of term loan
(interest expense related to ALX Oncology’s amortization of debt
discount) and (3) mark-to-market adjustment on financial
instruments (which include preferred stock warrants and
derivatives). 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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