ALX Oncology Reports Third Quarter 2020 Financial Results and Provides Clinical Development and Operational Highlights
12 Novembre 2020 - 10:05PM
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, 2020, and clinical
development and operational highlights.
“We are very pleased to report that during the third quarter we
continued to make substantial progress in advancing our next
generation anti-CD47 therapeutic, ALX148, in clinical trials in
advanced gastric/gastroesophageal junction cancer and head and neck
squamous cell cancers, as well as securing a clinical trial
collaboration with Merck to study the combination of ALX148 with
KEYTRUDA® in the setting of first line, metastatic
or unresectable, recurrent head and neck squamous cell cancer,”
said Jaume Pons, Ph.D., Founder, President and Chief Executive
Officer of ALX Oncology. “In addition, subsequent to the third
quarter, we announced the first patient has been dosed in the Phase
1/2 ASPEN-02 study evaluating the combination of ALX148 with
azacitidine for the treatment of patients with higher-risk
myelodysplastic syndromes. We also recently presented further
encouraging data for ALX148 from the ASPEN-01 Phase 1b Study at the
35th Annual SITC meeting, including a 64% ORR in advanced gastric
cancer patients treated with ALX148 in combination with trastuzumab
and the current chemotherapeutic standard of care. We look forward
to providing further updates as we continue to advance ALX148 as a
potential treatment for a range of solid tumor indications and
hematologic malignancies.”
Recent Clinical Developments for ALX148
- Presented New Data from the
ASPEN-01 Phase 1b Study of ALX148 in Combination with Standard
Chemotherapy and Antibody Regimens in Patients with
Gastric/Gastroesophageal Junction Cancer (“GC”) and Head and Neck
Squamous Cell Carcinoma (“HNSCC”) at the SITC
35th Anniversary Annual Meeting
[Abstract #404].
- In November 2020, ALX Oncology
reported new preliminary data from the GC patient cohort receiving
ALX148 plus trastuzumab plus chemotherapy. In patients with >2L
HER2 positive GC (n=14), whose tumors have progressed upon prior
trastuzumab therapy, ALX148 demonstrated an initial objective
response rate (“ORR”) of 64% in combination with trastuzumab plus
ramucirumab and paclitaxel that compares favorably with historical
data. In addition, updated data from patients with >2L HER2
positive GC receiving ALX148 plus trastuzumab suggested promising
clinical activity after their tumors have progressed upon prior
trastuzumab therapy.
- ALX Oncology also reported new
preliminary data from the HNSCC patient cohort receiving ALX148
plus pembrolizumab plus chemotherapy. In initial patients with 1L
HNSCC who have not received prior treatment for their advanced
disease (n=4), ALX148 demonstrated an initial ORR of 75%, including
a complete response, in combination with pembrolizumab plus
5-fluorouracil and platinum. In addition, updated data from
patients who have never been treated with a PD-1/PD-L1 inhibitor
for their >2L HNSCC and who received ALX148 plus pembrolizumab
suggested clinical activity beyond that expected from pembrolizumab
monotherapy.
- Collaboration Initiated with
Merck on Phase 2 Immuno-Oncology Studies Evaluating ALX148,
Targeting CD47, in Combination with KEYTRUDA® (pembrolizumab) in
Patients with Head & Neck Cancer. In September 2020,
ALX Oncology entered into a clinical trial collaboration with Merck
to evaluate the combination of ALX148 and KEYTRUDA®
(pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of
patients with HNSCC. ALX Oncology will conduct a Phase 2 program
comprising two separate Phase 2 studies. The first study will
evaluate the efficacy of ALX148 in combination with KEYTRUDA for
the first line treatment of patients with PD-L1 expressing
metastatic or unresectable, recurrent HNSCC. The second study will
evaluate ALX148 in combination with KEYTRUDA and standard
chemotherapy for the first line treatment of patients with
metastatic or unresectable, recurrent HNSCC.
- Announced the first patient
has been dosed in the Phase 1/2 ASPEN-02 study evaluating the
combination of ALX148 with azacitidine
for the treatment of patients with higher-risk
myelodysplastic syndromes (“MDS”). With the first patient
dosed in October 2020, the Phase 1 part of the study is expected to
characterize the safety of ALX148 in combination with azacitidine
in patients with relapsed/refractory or previously untreated
higher-risk MDS. Upon completion of the Phase 1, the Phase 2
component of the study will be initiated to evaluate the efficacy
of the combination in patients with previously untreated
higher-risk MDS.
Operational Highlights:
- Named Leading Oncology Experts
to Scientific Advisory Board. In October 2020, ALX
Oncology announced the formation of the Company’s Scientific
Advisory Board (“SAB”) with three leading oncology experts. The
members of the ALX Oncology SAB include Keith Flaherty, M.D.
(Chair), Charles M. Baum, M.D., Ph.D. and Kipp Weiskopf, M.D.,
Ph.D.
- Added to Russell
2000® and 3000® Indexes.
In September 2020, ALX Oncology was added as a member of the
Russell 2000® and 3000® Indexes effective as of September 18, 2020,
as part of Russell’s quarterly additions of select initial public
offering (“IPO”) companies.
Conference Call on November
16th at 5:00 p.m.
EST
New ALX148 Data from the Phase 1b GC Expansion Cohort in
ASPEN-01
ALX Oncology will host a conference call on Monday, November 16,
2020 at 5:00 p.m. EST to discuss the updated results from the GC
expansion cohort in ASPEN-01, the ALX148 Phase 1b study, which was
presented at the SITC 35th Anniversary Annual Meeting. In addition
to ALX Oncology’s executive management team, Dr. Yung-Jue Bang,
Professor Emeritus and former Director of Cancer Research
Institute, Seoul National University College of Medicine and
Hospital, South Korea, will be featured on the call to discuss the
latest ALX148 clinical data in patients with GC.
To access the conference call, please dial (844) 467-7655
(local) or (409) 983-9840 (international) at least 10 minutes prior
to the start time and refer to conference ID 4766826. Presentation
slides will be available to download under “News & Events” (see
“Events”) in the Investors section of the ALX Oncology website at
www.alxoncology.com.
Third Quarter 2020 Financial Results:
- Cash and Cash
Equivalents: Cash and cash equivalents as of September 30,
2020 were $259.5 million. ALX Oncology believes its cash and cash
equivalents is sufficient to fund planned operations through
2023.
- Related-party
Revenue: There was no related-party revenue for the
quarter ended September 30, 2020, compared to $1.3 million for the
corresponding period in 2019. 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 ALX148. These expenses for the three months ended
September 30, 2020, were $5.3 million, compared to $2.2 million for
the three months ended September 30, 2019. The increase of $3.1
million was primarily due to an increase of $2.9 million in
clinical and development costs due to higher expenses associated
with increased pre-clinical, clinical and other research costs in
advancement of our current lead product candidate, ALX148 and an
increase of $0.6 million in personnel-related costs, partially
offset by a decrease of $0.4 million 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,
2020, were $4.5 million, compared to $0.9 million for the
prior-year period. This increase of $3.5 million was primarily due
to an increase in stock-based compensation expense of $1.0 million,
an increase in professional service costs of $0.6 million,
additional $0.4 million in directors and officers liability
insurance premium, increased personnel-related costs of $1.2
million due to higher headcount and additional other G&A costs
of $0.3 million.
- Net loss: Net loss
attributable to common stockholders was $10.8 million and $4.1
million for the three months ended September 30, 2020, and 2019,
respectively. Included in the $10.8 million loss for the three
months ended September 30, 2020, was $0.6 million related to
cumulative dividends allocated to preferred shareholders, which,
along with prior cumulative dividends, were converted into 2.6
million shares of common stock at the IPO. Non-GAAP net loss was
$9.1 million and $3.0 million for the three months ended September
30, 2020, and 2019, respectively. A reconciliation of GAAP to
non-GAAP financial results can be found in a table 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, ALX148, is a next generation CD47 blocking
therapeutic that combines a high-affinity CD47 binding domain with
an inactivated, proprietary Fc domain. ALX148 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 ALX148 for the treatment of a range of solid tumor
indications and myelodysplastic syndromes. For more information,
please visit ALX Oncology’s website at www.alxoncology.com.
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 and the expectations regarding the beneficial
characteristics, safety, efficacy and therapeutic effects of
ALX148. clinical pipeline and the expectations regarding the
beneficial characteristics, safety, efficacy and therapeutic
effects of ALX148. These and other risks are described more fully
in ALX Oncology’s filings with the Securities and Exchange
Commission (“SEC”), including ALX Oncology’s Quarterly Report on
Form 10-Q, filed with the SEC on November 12, 2020, 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)
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
Related-party revenue |
$ |
— |
|
$ |
1,256 |
|
$ |
1,182 |
|
$ |
3,583 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
5,328 |
|
|
2,210 |
|
|
16,819 |
|
|
9,571 |
|
General and administrative |
|
4,481 |
|
|
938 |
|
|
9,126 |
|
|
2,205 |
|
Cost of services for related-party revenue |
|
— |
|
|
1,142 |
|
|
1,075 |
|
|
3,257 |
|
Total operating expenses |
|
9,809 |
|
|
4,290 |
|
|
27,020 |
|
|
15,033 |
|
Loss from operations |
|
(9,809 |
) |
|
(3,034 |
) |
|
(25,838 |
) |
|
(11,450 |
) |
Interest expense |
|
(226 |
) |
|
— |
|
|
(660 |
) |
|
— |
|
Other expense, net |
|
(111 |
) |
|
(2 |
) |
|
(409 |
) |
|
(4 |
) |
Loss before income taxes |
|
(10,146 |
) |
|
(3,036 |
) |
|
(26,907 |
) |
|
(11,454 |
) |
Income tax provision |
|
(35 |
) |
|
(8 |
) |
|
(59 |
) |
|
(25 |
) |
Net loss and comprehensive
loss |
|
(10,181 |
) |
|
(3,044 |
) |
|
(26,966 |
) |
|
(11,479 |
) |
Cumulative dividends allocated to
preferred stockholders |
|
(578 |
) |
|
(1,071 |
) |
|
(5,202 |
) |
|
(2,957 |
) |
Net loss attributable to common
stockholders |
$ |
(10,759 |
) |
$ |
(4,115 |
) |
$ |
(32,168 |
) |
$ |
(14,436 |
) |
Condensed Consolidated Balance Sheet
Data(unaudited)(in thousands)
|
|
September 30, 2020 |
|
|
December 31, 2019 |
|
Cash and cash equivalents |
$ |
259,484 |
|
$ |
9,017 |
|
Total assets |
$ |
262,449 |
|
$ |
10,676 |
|
Total liabilities |
$ |
10,433 |
|
$ |
10,952 |
|
Convertible preferred stock |
$ |
— |
|
$ |
70,363 |
|
Total stockholders’
equity/(deficit) |
$ |
252,016 |
|
$ |
(70,639 |
) |
GAAP to Non-GAAP Reconciliation
(unaudited) (in thousands)
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
GAAP net loss, as reported |
$ |
(10,181 |
) |
$ |
(3,044 |
) |
$ |
(26,966 |
) |
$ |
(11,479 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
689 |
|
|
86 |
|
|
3,693 |
|
|
222 |
|
Accretion of term loan |
|
118 |
|
|
— |
|
|
339 |
|
|
— |
|
Mark-to-market adjustment on financial instruments |
|
242 |
|
|
— |
|
|
650 |
|
|
— |
|
Total adjustments |
|
1,049 |
|
|
86 |
|
|
4,682 |
|
|
222 |
|
Non-GAAP net loss |
$ |
(9,132 |
) |
$ |
(2,958 |
) |
$ |
(22,284 |
) |
$ |
(11,257 |
) |
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“ is not based on any standardized
methodology prescribed by GAAP and represent GAAP net loss adjusted
to exclude (1) stock-based compensation expense, (2) debt offering
costs (interest expense related to ALX Oncology’s term loan
offering costs) and (3) mark-to market adjustment on financial
instruments (which include preferred stock warrants and
derivatives) within our reconciliation of our GAAP
to Non-GAAP net loss. 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 GarciaChief Financial Officer, ALX Oncology(650) 466-7125
Ext. 113peter@alxoncology.com
Argot Partners(212)-600-1902alxoncology@argotpartners.com
Media Contact:
Karen SharmaMacDougall(781) 235-3060alx@macbiocom.com
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