ALX Oncology Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Clinical Development and Operational Highlights and Upcoming Milestones
February 28 2022 - 7:00AM
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, 2021 and
provided clinical development and operational highlights.
“ALX Oncology achieved key milestones in 2021 to advance our
lead program, evorpacept, a next-generation CD47 blocker, through
multiple clinical trials,” said Jaume Pons, Ph.D., Founder,
President and Chief Executive Officer of ALX Oncology. “Notable
accomplishments included initiating two Phase 2 trials in head and
neck squamous cell carcinoma (“HNSCC”) and presenting encouraging
Phase 1b data from the ASPEN-01 trial in gastric/gastroesophageal
junction (“GEJ”) cancer and HNSCC, along with early Phase 1a data
from the ASPEN-02 trial in myelodysplastic syndromes (“MDS”). Data
from these trials also showed evorpacept to be well tolerated when
combined with anti-cancer antibodies and multi-agent chemotherapy
regimens in solid tumors and with azacitidine in MDS.”
Dr. Pons added: “2022 is expected to be another productive year
with the anticipated initiation of a randomized Phase 2/3 clinical
trial of evorpacept in combination with trastuzumab, ramucirumab
and paclitaxel in patients with 2nd line or greater gastric/GEJ
cancer and the expected completion of enrollment and dose
optimization data readout from our Phase 1b clinical trial of
evorpacept in combination with azacitidine in patients with MDS.
The design of evorpacept, with an inactive Fc, continues to set us
apart from competing CD47 blockers to date. Our data suggest that
evorpacept’s inactive Fc approach shows greater tolerability than
CD47 blocking approaches using an active Fc domain, several of
which have shown significant cytopenias in the clinic.
Additionally, our initial clinical data show anti-tumor activity on
par or better than other such agents.”
Anticipated Key Clinical Milestones for
2022
- Initiation of a randomized Phase 2/3
clinical trial of evorpacept in combination with Herceptin®
(trastuzumab), Cyramza® (ramucirumab) and paclitaxel in patients
with 2nd line or greater gastric/GEJ cancer (ASPEN-06).
- Dose optimization readout of a Phase
1b clinical trial of evorpacept in combination with azacitidine in
patients with MDS (ASPEN-02).
- Initiate and provide updates on
investigator sponsored clinical trials with evorpacept.
- Provide updates on ongoing
collaboration with Zymeworks in HER2-expressing breast cancer and
other solid tumors.
- Select development candidate(s) from
preclinical pipeline.
Recent Clinical Developments for Evorpacept
(ALX148)
- U.S. Food and Drug
Administration (“FDA”) Granted Orphan Drug Designation (“ODD”) for
Evorpacept for the Treatment of Patients with Gastric/GEJ
Cancer
- In January 2022, ALX announced that
the U.S. FDA granted ODD to evorpacept, a next-generation CD47
blocker, for the treatment of patients with gastric/GEJ
cancer.
- Presented Initial Phase 1a
Clinical Data in Combination with Azacitidine in Patients with MDS
(ASPEN-02) at ASH
- In December 2021, the Company
presented initial clinical data from its ongoing trial evaluating
evorpacept in combination with azacitidine for the treatment of
patients with previously untreated higher-risk or relapsed or
refractory MDS. The new data, shared in a poster at the 63rd
American Society of Hematology (“ASH”) Annual Meeting [Abstract
#2601], show that the combination of evorpacept and azacitidine is
active and well-tolerated. Patient accrual is ongoing in the Phase
1b dose optimization part of the study.
- Presented Updated Phase 1b
Clinical Trial Data in Combination with Pembrolizumab with and
without Chemotherapy in Patients with HNSCC and in Combination with
Trastuzumab, Ramucirumab, and Paclitaxel in Patients with
Gastric/GEJ Cancer (ASPEN-01) at SITC
- In November 2021, updated results from
Phase 1b study (ASPEN-01) evaluating patients with solid tumor
malignancies were presented at the Society for Immunotherapy of
Cancer’s 36th Anniversary Annual Meeting [Abstract #498]. ALX
Oncology reported updated results from the gastric/GEJ 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.
- Initiation of a Phase 1a
Clinical Trial in Combination with Venetoclax and Azacitidine in
Acute Myeloid Leukemia (ASPEN-05)
- In October 2021, the first patient was
dosed in the Phase 1/2 ASPEN-05 study evaluating the combination of
evorpacept with venetoclax and azacitidine for the treatment of
patients with acute myeloid leukemia (“AML”). The Phase 1 portion
will characterize the safety 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.
- Initiation of a Phase 1b/2
Clinical Trial in Combination with Zanidatamab 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.
Recent Corporate Updates
- Acquired Privately Held
ScalmiBio Inc.: In October 2021, ALX Oncology acquired
ScalmiBio which further expanded its pipeline with plans to develop
novel antibody-drug conjugates (“ADCs”) based on ScalmiBio’s SHIELD
platform.
Full Year and Fourth Quarter 2021 Financial
Results:
- Cash and Cash
Equivalents: Cash and cash equivalents as of December 31,
2021 were $363.7 million. ALX Oncology believes its cash and cash
equivalents is sufficient to fund planned operations through
mid-2024.
- Related-party
Revenue: There was no related-party revenue for the three
months ended December 31, 2021 and 2020. There was no related-party
revenue for the year ended December 31, 2021, compared to $1.2
million for the prior-year period. The decrease
in related-party revenue relates to the termination
of the research and development agreement with Tallac Therapeutics,
Inc. in July 2020.
- 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 December 31, 2021, were $20.9 million,
compared to $12.1 million for the prior-year period. Expenses for
the three months ended December 31, 2021 included $4.7 million of
acquired in-process research and development expenses related to
the acquisition of ScalmiBio. R&D expenses for the year ended
December 31, 2021, were $60.2 million, compared to $29.0 million
for the prior-year period.
- 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 December 31,
2021, were $7.6 million, compared to $5.7 million for the
prior-year period. G&A expenses for the year ended December 31,
2021, were $23.4 million, compared to $14.8 million for the
prior-year period.
- Net loss: GAAP net
loss attributable to common stockholders was $28.4 million for the
fourth quarter ended December 31, 2021, or $0.70 per basic and
diluted share, as compared to a net loss of $18.8 million for the
fourth quarter ended December 31, 2020, or $0.50 per basic and
diluted share. GAAP net loss for the year ended December 31, 2021
was $83.5 million, or $2.07 per basic and diluted share, as
compared to $50.9 million, or $2.76 per basic and diluted share,
for the year ended December 31, 2020. Non-GAAP net loss was $22.8
million for the fourth quarter ended December 31, 2021, as compared
to a net loss of $16.3 million for the fourth quarter ended
December 31, 2020. Non-GAAP net loss for the year ended December
31, 2021 was $69.5 million, as compared to $43.8 million for the
year ended December 31, 2020. 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 and Comprehensive Loss(unaudited)(in thousands,
except share and per share amounts)
|
|
Three Months Ended |
|
|
Year Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Related-party revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
1,182 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
20,894 |
|
|
|
12,142 |
|
|
|
60,170 |
|
|
|
28,961 |
|
General and administrative |
|
|
7,578 |
|
|
|
5,683 |
|
|
|
23,385 |
|
|
|
14,809 |
|
Cost of services for related-party revenue |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,075 |
|
Total operating expenses |
|
|
28,472 |
|
|
|
17,825 |
|
|
|
83,555 |
|
|
|
44,845 |
|
Loss from operations |
|
|
(28,472 |
) |
|
|
(17,825 |
) |
|
|
(83,555 |
) |
|
|
(43,663 |
) |
Interest expense |
|
|
(3 |
) |
|
|
(151 |
) |
|
|
(13 |
) |
|
|
(811 |
) |
Other income (expense), net |
|
|
16 |
|
|
|
5 |
|
|
|
84 |
|
|
|
(404 |
) |
Loss on early debt
extinguishment |
|
|
— |
|
|
|
(621 |
) |
|
|
— |
|
|
|
(621 |
) |
Loss before income taxes |
|
|
(28,459 |
) |
|
|
(18,592 |
) |
|
|
(83,484 |
) |
|
|
(45,499 |
) |
Income tax benefit
(provision) |
|
|
21 |
|
|
|
(182 |
) |
|
|
21 |
|
|
|
(241 |
) |
Net loss and comprehensive
loss |
|
|
(28,438 |
) |
|
|
(18,774 |
) |
|
|
(83,463 |
) |
|
|
(45,740 |
) |
Cumulative dividends allocated to
preferred stockholders |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(5,202 |
) |
Net loss attributable to common
stockholders |
|
$ |
(28,438 |
) |
|
$ |
(18,774 |
) |
|
$ |
(83,463 |
) |
|
$ |
(50,942 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
|
$ |
(0.70 |
) |
|
$ |
(0.50 |
) |
|
$ |
(2.07 |
) |
|
$ |
(2.76 |
) |
Weighted-average shares of common
stock used to compute net loss per share attributable to common
stockholders, basic and diluted |
|
|
40,527,314 |
|
|
|
37,642,897 |
|
|
|
40,308,050 |
|
|
|
18,485,343 |
|
Condensed Consolidated Balance Sheet
Data(unaudited)(in thousands)
|
|
December 31,2021 |
|
|
December 31,2020 |
|
Cash and cash equivalents |
|
$ |
363,667 |
|
|
$ |
434,219 |
|
Total assets |
|
$ |
380,183 |
|
|
$ |
436,054 |
|
Total liabilities |
|
$ |
17,134 |
|
|
$ |
6,209 |
|
Accumulated deficit |
|
$ |
(201,985 |
) |
|
$ |
(118,522 |
) |
Total stockholders’ equity |
|
$ |
363,049 |
|
|
$ |
429,845 |
|
GAAP to Non-GAAP Reconciliation
(unaudited) (in thousands)
|
|
Three Months Ended |
|
|
Year Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
GAAP net loss attributable to common stockholders, as Reported |
|
$ |
(28,438 |
) |
|
$ |
(18,774 |
) |
|
$ |
(83,463 |
) |
|
$ |
(50,942 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
|
5,686 |
|
|
|
1,743 |
|
|
|
13,914 |
|
|
|
5,436 |
|
Accretion of term loan |
|
|
— |
|
|
|
82 |
|
|
|
— |
|
|
|
421 |
|
Mark-to-market adjustment on financial instruments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
650 |
|
Loss on early debt extinguishment |
|
|
— |
|
|
|
621 |
|
|
|
— |
|
|
|
621 |
|
Total adjustments |
|
|
5,686 |
|
|
|
2,446 |
|
|
|
13,914 |
|
|
|
7,128 |
|
Non-GAAP net loss attributable to
common stockholders |
|
$ |
(22,752 |
) |
|
$ |
(16,328 |
) |
|
$ |
(69,549 |
) |
|
$ |
(43,814 |
) |
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), (3)
mark-to-market adjustment on financial instruments (which include
preferred stock warrants and derivatives) and (4) loss on early
debt extinguishment. 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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