ALX Oncology Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Clinical Development and Operational Highlights and Upcoming Milestones
March 09 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 fourth quarter and year ended December 31, 2022 and
provided clinical development and operational highlights.
“2022 was a productive year for us, with numerous clinical and
corporate development accomplishments highlighted by the
advancement of our lead program, evorpacept, for the treatment of
multiple solid tumor indications and hematological malignancies. We
also expanded evorpacept into new indications and combinations,”
said Dr Jaume Pons, Ph.D., Founder, President and Chief Executive
Officer of ALX Oncology. “These included a Phase 1 trial in
urothelial cancer (“UC”) in combination with PADCEV®, and a new
investigational treatment arm in the I-SPY-P1 trial for the
treatment of patients with unresectable or metastatic HER2-positive
and HER2-low breast cancer in combination with ENHERTU® in
partnership with Quantum Leap Healthcare Collaborative.”
Dr. Pons added, “2023 is expected to be an eventful year for ALX
Oncology with the presentation of data from ASPEN-06, a randomized
Phase 2 trial of evorpacept in combination with trastuzumab,
ramucirumab and paclitaxel for the treatment of patients with
HER2-positive gastric/gastroesophageal junction (“GEJ”) cancer in
the second half of 2023, and the presentation of dose optimization
results from ASPEN-02, a Phase 1b clinical trial of evorpacept in
combination with azacitidine in patients with myelodysplastic
syndromes (“MDS”) in the second half of 2023. Additionally, we are
on track to file an Investigational New Drug (“IND”) application in
the first half of 2023, in collaboration with Tallac Therapeutics,
for ALTA-002 that will further expand our clinical pipeline beyond
evorpacept.”
Anticipated Key Milestones in 2023
- Presentation of data from a randomized Phase 2 trial of
evorpacept in combination with trastuzumab, ramucirumab and
paclitaxel for the treatment of patients with HER2-positive
gastric/GEJ cancer (ASPEN-06) in the second half of 2023.
- Presentation of dose optimization results of a Phase 1b
clinical trial of evorpacept in combination with azacitidine in
patients with MDS (ASPEN-02) in the second half of 2023.
- Initiation of a Phase 1b dose optimization clinical trial of
evorpacept in combination with azacitidine and venetoclax for the
treatment of patients with relapsed or refractory (“r/r”) or newly
diagnosed (“ND”) acute myeloid leukemia (“AML”) (ASPEN-05) in the
second half of 2023.
- Filing an IND for ALTA-002, a SIRPα Toll-like receptor agonist
antibody conjugate in collaboration with Tallac Therapeutics in the
first half of 2023.
- Expansion of the antibody-drug conjugate (“ADC”) platform
acquired from ScalmiBio to identify clinical development candidates
by the second half of 2023.
Recent Clinical Developments for Evorpacept
- First patient dosed in ASPEN-07 study evaluating
evorpacept in combination with PADCEV® (enfortumab vedotin-ejfv),
an ADC, in patients with UC.
- In February 2023, ALX Oncology announced the first patient was
dosed in the Phase 1 ASPEN-07 study evaluating evorpacept in
combination with 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 enfortumab
vedotin-ejfv in subjects with unresectable locally advanced or
metastatic UC.
- Presented initial clinical data from the Phase 1a dose
escalation portion of the ASPEN-05 trial evaluating evorpacept in
combination with azacitidine and venetoclax for the treatment of
patients with r/r or ND AML at American Society of Hematology
(“ASH”).
- In December 2022, ALX Oncology presented a poster presentation
at ASH showing that the combination of evorpacept with azacitidine
and venetoclax is active and generally well tolerated. As of
October 3, 2022, 14 patients with either r/r or ND AML have been
treated with evorpacept in the Phase 1 dose escalation part of the
study, administered at 20 mg/kg or 30 mg/kg once every 2 weeks or
60 mg/kg once every 4 weeks (“Q4W”) together with standard dosing
of azacitidine and venetoclax.
- Evorpacept in combination with azacitidine and venetoclax was
generally well tolerated (N=14) with no maximum tolerated dose
identified and a maximum administered dose of 60 mg/kg Q4W. In 10
relapsed or refractory AML response-evaluable patients, including 8
that had progressed after prior venetoclax treatment, all
experienced a reduction in bone marrow blasts, and 4 achieved a
response. In 3 newly diagnosed AML response-evaluable patients, all
3 achieved a response, including 1 complete response (“CR”), 1 CR
with incomplete hematologic recovery, and 1 morphologic leukemia
free state.
- Presented data from ASPEN-03 and ASPEN-04, the
Company’s Phase 2 head and neck squamous cell carcinoma (“HNSCC”)
studies at Society for Immunotherapy of Cancer (“SITC”).
- In November 2022, ALX Oncology presented two Trials in Progress
abstracts at SITC related to ASPEN-03 and ASPEN-04. ALX Oncology
continues to advance ASPEN-03 and ASPEN-04, which are two distinct
randomized Phase 2 studies for the treatment of patients with
advanced HNSCC in combination with pembrolizumab with or without
chemotherapy. Patient enrollment for ASPEN-03 and ASPEN-04
continues as planned.
Recent Corporate Updates
- In October 2022, ALX Oncology entered into a loan facility with
Oxford Finance LLC and Silicon Valley Bank for up to $100 million
of non-dilutive financing. Under the terms of the loan agreement,
ALX Oncology drew $10 million of an initial $50 million tranche at
closing, with the remaining $40 million available at its discretion
through the end of 2023. ALX Oncology also has access up to an
additional $50 million with $12.5 million available in each of two
tranches based upon the achievement of milestones related to the
development of evorpacept and one pre-clinical product candidate,
and $25 million available at the Lenders’ discretion.
- In November 2022, strengthened board of directors by adding an
additional independent board member with significant operational
and commercial leadership experience in the biopharmaceutical
industry:
- Scott Garland, currently strategic advisor and member of the
board of directors at Pact Pharma and previously Chief Executive
Officer of Portola Pharmaceuticals, has more than 30 years of
biopharmaceutical industry knowledge and brings deep commercial and
executive leadership experience.
Full Year and Fourth Quarter 2022 Financial
Results:
- Cash, Cash Equivalents and Investments: Cash,
cash equivalents and investments as of December 31, 2022 were
$282.9 million. ALX Oncology believes its cash, cash equivalents,
investments and the ability to draw down up to 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 December 31, 2022 were $25.2 million, compared to $20.9
million for the prior-year period. R&D expenses for the year
ended December 31, 2022 were $98.4 million, compared to $60.2
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,
2022 were $7.0 million, compared to $7.6 million for the prior-year
period. G&A expenses for the year ended December 31, 2022 were
$29.0 million, compared to $23.4 million for the prior-year
period.
- Net loss: GAAP net loss was $30.7 million for
the fourth quarter ended December 31, 2022, or $0.75 per basic and
diluted share, as compared to a net loss of $28.4 million for the
fourth quarter ended December 31, 2021, or $0.70 per basic and
diluted share. GAAP net loss for the year ended December 31, 2022
was $123.5 million, or $3.03 per basic and diluted share, as
compared to $83.5 million, or $2.07 per basic and diluted share,
for the year ended December 31, 2021. Non-GAAP net loss was $24.4
million for the fourth quarter ended December 31, 2022, as compared
to a net loss of $22.8 million for the fourth quarter ended
December 31, 2021. Non-GAAP net loss for the year ended December
31, 2022 was $99.6 million, as compared to $69.5 million for the
year ended December 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 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 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 commercial 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.Consolidated Statements of
Operations(unaudited for the three months ended December
31, 2022 and 2021)(in thousands, except share and per share
amounts)
|
|
Three Months Ended |
|
|
Year Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
25,197 |
|
|
$ |
20,894 |
|
|
$ |
98,400 |
|
|
$ |
60,170 |
|
General and administrative |
|
|
7,022 |
|
|
|
7,578 |
|
|
|
29,036 |
|
|
|
23,385 |
|
Total operating expenses |
|
|
32,219 |
|
|
|
28,472 |
|
|
|
127,436 |
|
|
|
83,555 |
|
Loss from operations |
|
|
(32,219 |
) |
|
|
(28,472 |
) |
|
|
(127,436 |
) |
|
|
(83,555 |
) |
Interest income |
|
|
1,807 |
|
|
|
21 |
|
|
|
4,278 |
|
|
|
91 |
|
Other expense, net |
|
|
(233 |
) |
|
|
(8 |
) |
|
|
(260 |
) |
|
|
(20 |
) |
Loss before income taxes |
|
|
(30,645 |
) |
|
|
(28,459 |
) |
|
|
(123,418 |
) |
|
|
(83,484 |
) |
Income tax (provision)
benefit |
|
|
(64 |
) |
|
|
21 |
|
|
|
(64 |
) |
|
|
21 |
|
Net loss |
|
$ |
(30,709 |
) |
|
$ |
(28,438 |
) |
|
$ |
(123,482 |
) |
|
$ |
(83,463 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.75 |
) |
|
$ |
(0.70 |
) |
|
$ |
(3.03 |
) |
|
$ |
(2.07 |
) |
Weighted-average shares of
common stock used to compute net loss per shares,
basic and diluted |
|
|
40,755,520 |
|
|
|
40,527,314 |
|
|
|
40,699,612 |
|
|
|
40,308,050 |
|
Consolidated Balance Sheet
Data(in thousands)
|
|
December 31, |
|
|
|
2022 |
|
|
2021 |
|
Cash, cash equivalents and investments |
|
$ |
282,906 |
|
|
$ |
363,667 |
|
Total assets |
|
$ |
306,489 |
|
|
$ |
380,183 |
|
Total liabilities |
|
$ |
43,025 |
|
|
$ |
17,134 |
|
Accumulated deficit |
|
$ |
(325,467 |
) |
|
$ |
(201,985 |
) |
Total stockholders’
equity |
|
$ |
263,464 |
|
|
$ |
363,049 |
|
GAAP to Non-GAAP Reconciliation
(unaudited) (in thousands)
|
|
Three Months Ended |
|
|
Year Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
GAAP net loss, as reported |
|
$ |
(30,709 |
) |
|
$ |
(28,438 |
) |
|
$ |
(123,482 |
) |
|
$ |
(83,463 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
|
6,295 |
|
|
|
5,686 |
|
|
|
23,839 |
|
|
|
13,914 |
|
Accretion of term loan |
|
|
44 |
|
|
|
— |
|
|
|
44 |
|
|
|
— |
|
Total adjustments |
|
|
6,339 |
|
|
|
5,686 |
|
|
|
23,883 |
|
|
|
13,914 |
|
Non-GAAP net loss |
|
$ |
(24,370 |
) |
|
$ |
(22,752 |
) |
|
$ |
(99,599 |
) |
|
$ |
(69,549 |
) |
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. 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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