ALX Oncology Reports Third Quarter 2024 Financial Results and Provides Corporate Update
November 07 2024 - 3:00PM
ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”)
(Nasdaq: ALXO), a clinical-stage biotechnology company advancing
therapies that boost the immune system to treat cancer in new ways
and extend patients’ lives, today reported financial results for
the third quarter ended September 30, 2024, and provided a
corporate update.
“We made substantial clinical progress during the third quarter,
most notably announcing topline data from our ASPEN-06 Phase 2
trial in which our lead candidate evorpacept became the first and
only CD47-blocking agent to show a durable clinical benefit and a
well-tolerated safety profile in a prospective randomized clinical
trial,” said Jason Lettmann, Chief Executive Officer of ALX
Oncology. “These results provided further validation for
evorpacept’s novel mechanism of action and our robust evorpacept
clinical program. We anticipate achieving several additional
clinical milestones in the near-term that could advance evorpacept
towards being a best-in-class, combinable therapeutic across a wide
range of cancer types.”
Third Quarter 2024 Highlights and Recent
Developments
- Reported topline data results in July from the multi-center,
international ASPEN-06 Phase 2 clinical trial (NCT05002127)
evaluating evorpacept in combination with HERCEPTIN® (trastuzumab),
CYRAMZA® (ramucirumab) and paclitaxel (Evo-TRP) against
trastuzumab, CYRAMZA (ramucirumab) and paclitaxel (TRP) for the
treatment of patients with HER2-positive gastric/gastroesophageal
junction (GEJ) cancer, where all patients had received an anti-HER2
agent in prior lines of therapy.
- Evorpacept improved tumor response in patients with
HER2-positive gastric/GEJ cancer, becoming the first CD47 blocker
to show promising and durable response with a well-tolerated safety
profile in a prospective randomized study.
- Evo-TRP achieved a confirmed overall response rate (ORR) of
40.3% compared to 26.6% for the TRP control arm and demonstrated a
median duration of response of 15.7 months compared to 7.6 months
in the intent to treat population (ITT) (N=127). The primary
analysis of the ITT compared Evo-TRP to an assumed RP control ORR
of 30% Secondary endpoints of PFS and OS were immature at the time
of analysis.
- Evo-TRP combination showed the greatest response with an ORR of
54.8% compared to 23.1% in the TRP control arm in a pre-specified
population of patients with fresh HER2-positive biopsies
(n=48).
- In September, commenced patient dosing to investigate
evorpacept plus SARCLISA® (isatuximab-irfc) and dexamethasone in
patients with relapsed or refractory multiple myeloma (RRMM) in the
Sanofi-partnered arm of the randomized UMBRELLA phase 1/2 clinical
study.
- Sanofi is conducting the two-part multicenter, randomized,
open-label, controlled, parallel-group study (NCT04643002) to
evaluate the safety, efficacy, pharmacokinetics and biomarker data
of evorpacept in combination with SARCLISA and dexamethasone in
patients with RRMM.
- Part 1 is evaluating the dosing of evorpacept in combination
with standard doses of SARCLISA and dexamethasone to identify a
recommended evorpacept dose.
- Part 2 is investigating the efficacy and safety of this
three-drug combination in an expanded population of patients with
RRMM.
- In August, enhanced the leadership team by appointing Alan
Sandler, M.D. to Board of Directors, a distinguished leader in
oncology and drug development with over 30 years of experience
across industry and academia.
- Dr. Sandler’s industry background includes serving as Executive
Vice President, Chief Medical Officer at Mirati Therapeutics, prior
to its acquisition by Bristol Myers Squibb. Before joining Mirati,
he served as President, Global Head of Development in Oncology at
Zai Lab, and prior to that, he was the Senior Vice President and
Global Head, Product Development of Oncology Solid Tumors at
Genentech, a member of the Roche Group.
- Presented at the 2024 Cantor Fitzgerald Global Healthcare
Conference in New York City in September.
- Participated in fireside chat with Analyst, Li Watsek and
conducted investor meetings.
Upcoming Clinical Milestones for
Evorpacept’s Development Pipeline
- Breast Cancer – Results from a Phase 1b/2 combination trial
evaluating evorpacept in combination with Jazz Pharmaceuticals’
zanidatamab in HER2-positive and HER2-low metastatic breast cancer
will be presented at a poster spotlight presentation at the San
Antonio Breast Cancer Symposium on December 12, 2024
- Gastric/GEJ Cancer – Updated results of ASPEN-06 Phase 2
clinical trial (1H 2025)
- Head and Neck Squamous Cell Carcinoma – Topline results from a
Phase 2 randomized clinical trial of ASPEN-03 with KEYTRUDA®
(pembrolizumab) (1H 2025)
- Head and Neck Squamous Cell Carcinoma – Topline results from a
Phase 2 randomized clinical trial of ASPEN-04 with KEYTRUDA and
chemotherapy (1H 2025)
- Urothelial Cancer – Updated results from a Phase 1 clinical
trial of ASPEN-07 in combination with PADCEV® (enfortumab vedotin)
(1H 2025)
- Gastric/GEJ Cancer – Initiation of Phase 3 registrational
randomized clinical trial for evorpacept (mid-2025)
- Breast Cancer – Topline results from a Phase 1b I-SPY TRIAL
with ENHERTU® (fam-trastuzumab deruxtecan-nxki) (2H 2025)
Third Quarter 2024 Financial Results:
- Cash, Cash Equivalents and Investments: Cash,
cash equivalents and investments as of September 30, 2024, were
$162.6 million. The Company believes its cash, cash equivalents and
investments, which includes the proceeds from sales under its
at-the-market (“ATM”) offering in the first half of 2024 are
sufficient to fund planned operations well into Q1 2026.
- 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 September 30, 2024, were $26.5 million, compared to $45.8
million for the prior-year period. R&D expenses decreased by
$19.3 million during the three months ended September 30, 2024,
compared to the three months ended September 30, 2023. Lower
expense was primarily attributable to a decrease of $22.2 million
in clinical and development costs primarily due to manufacturing of
clinical trial materials to support active clinical trials for our
lead product candidate, evorpacept, slightly offset by increased
preclinical costs for development of new targets, an increase in
personnel and related costs, and an increase in stock-based
compensation expense.
- 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,
2024, were $6.1 million, compared to $7.5 million for the prior
year period. G&A expenses decreased by $1.4 million during the
three months ended September 30, 2024, compared to the three months
ended September 30, 2023. The decrease was primarily attributable
to lower stock-based compensation expense and lower accounting
consulting costs.
- Net loss: GAAP net loss was $30.7 million for
the three months ended September 30, 2024, or ($0.58) per basic and
diluted share, as compared to a GAAP net loss of $51.0 million for
the three months ended September 30, 2023, or ($1.24) per basic and
diluted share. Non-GAAP net loss was $23.7 million for the three
months ended September 30, 2024, as compared to a non-GAAP net loss
of $44.0 million for the three months ended September 30, 2023. A
reconciliation of GAAP to non-GAAP financial results can be found
at the end of this news release.
About ALX Oncology
ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology
company advancing therapies that boost the immune system to treat
cancer in new ways and extend patients’ lives. ALX Oncology’s lead
therapeutic candidate, evorpacept, has demonstrated potential to
serve as a cornerstone therapy upon which the future of
immuno-oncology can be built. Evorpacept is currently being
evaluated across multiple ongoing clinical trials in a wide range
of cancer indications. More information is available at
www.alxoncology.com and on LinkedIn @ALX Oncology.
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 |
|
|
Nine Months
Ended |
|
|
September 30, |
|
|
September 30, |
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
26,471 |
|
|
$ |
45,766 |
|
|
$ |
92,841 |
|
|
$ |
100,011 |
|
General and administrative |
|
6,096 |
|
|
|
7,509 |
|
|
|
19,013 |
|
|
|
22,244 |
|
Total operating expenses |
|
32,567 |
|
|
|
53,275 |
|
|
|
111,854 |
|
|
|
122,255 |
|
Loss from operations |
|
(32,567 |
) |
|
|
(53,275 |
) |
|
|
(111,854 |
) |
|
|
(122,255 |
) |
Interest income |
|
2,303 |
|
|
|
2,677 |
|
|
|
7,488 |
|
|
|
7,654 |
|
Interest expense |
|
(446 |
) |
|
|
(391 |
) |
|
|
(1,302 |
) |
|
|
(1,150 |
) |
Other (expense) income, net |
|
3 |
|
|
|
(1 |
) |
|
|
(19 |
) |
|
|
418 |
|
Net loss |
$ |
(30,707 |
) |
|
$ |
(50,990 |
) |
|
$ |
(105,687 |
) |
|
$ |
(115,333 |
) |
Net loss per share, basic and
diluted |
$ |
(0.58 |
) |
|
$ |
(1.24 |
) |
|
$ |
(2.05 |
) |
|
$ |
(2.82 |
) |
Weighted-average shares of common
stock used to compute net loss per shares, basic and diluted |
|
52,693,878 |
|
|
|
41,147,938 |
|
|
|
51,544,501 |
|
|
|
40,963,015 |
|
Condensed
Consolidated Balance Sheet Data(in thousands) |
|
|
September 30, |
|
|
December 31, |
|
|
2024 |
|
|
2023 |
|
Cash, cash equivalents and investments |
$ |
162,610 |
|
|
$ |
218,147 |
|
Total assets |
$ |
185,715 |
|
|
$ |
242,553 |
|
Total liabilities |
$ |
48,908 |
|
|
$ |
52,841 |
|
Accumulated deficit |
$ |
(591,959 |
) |
|
$ |
(486,272 |
) |
Total stockholders’ equity |
$ |
136,807 |
|
|
$ |
189,712 |
|
GAAP to
Non-GAAP Reconciliation(unaudited)(in thousands) |
|
|
Three Months
Ended |
|
|
Nine Months
Ended |
|
|
September 30, |
|
|
September 30, |
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
GAAP net loss, as reported |
$ |
(30,707 |
) |
|
$ |
(50,990 |
) |
|
$ |
(105,687 |
) |
|
$ |
(115,333 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
6,952 |
|
|
|
6,964 |
|
|
|
21,235 |
|
|
|
19,552 |
|
Accretion of term loan discount and issuance costs |
|
66 |
|
|
|
63 |
|
|
|
196 |
|
|
|
186 |
|
Total adjustments |
|
7,018 |
|
|
|
7,027 |
|
|
|
21,431 |
|
|
|
19,738 |
|
Non-GAAP net loss |
$ |
(23,689 |
) |
|
$ |
(43,963 |
) |
|
$ |
(84,256 |
) |
|
$ |
(95,595 |
) |
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 represents 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.
Company Contact: Caitlyn Doherty, Manager, Corporate Communications, ALX Oncology, cdoherty@alxoncology.com, (650) 466-7125
Investor Contact: Malini Chatterjee, Ph.D., Blueprint Life Science Group, mchatterjee@bplifescience.com, (917) 330-4269
Media Contact: Audra Friis, Sam Brown, Inc., audrafriis@sambrown.com, (917) 519-9577
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