ALX Oncology Reports Second Quarter 2020 Financial Results and Provides Operational and Clinical Highlights
27 Agosto 2020 - 10:05PM
ALX Oncology Holdings Inc., (“ALX Oncology” or the “Company”)
(Nasdaq: ALXO) a clinical-stage immuno-oncology company developing
therapies that block the CD47 checkpoint pathway, today reported
financial results for the second quarter ended June 30, 2020, and
operational and clinical development highlights.
“Our mission is to leverage the unique profile of ALX148 to
transform the lives of patients with cancer,” said Jaume Pons,
Ph.D., President and Chief Executive Officer of ALX Oncology. “We
believe ALX148, our lead development candidate, is emerging as a
next-generation checkpoint inhibitor designed to have high affinity
for CD47 and to overcome hematologic toxicity limitations
associated with other CD47 blocking approaches in the clinic. With
the successful completion of our initial public offering in July,
we have a strong cash position to advance ALX148 in multiple
clinical trials for hematologic and solid tumor malignancies in
combination with a number of leading anti-cancer agents. We are
focused on executing our clinical development plans and look
forward to providing more updates in the future.”
Operational Highlights:
- Completed initial public offering
(“IPO”). In July 2020, ALX Oncology closed an upsized
IPO of 9,775,000 of its common stock, including the exercise in
full of the underwriters’ option, at a public offering price of
$19.00 per share. The aggregate gross proceeds to ALX Oncology from
the IPO were approximately $185.7 million, before deducting
underwriting discounts and commissions and other offering expenses.
The Company’s common stock commenced trading on the Nasdaq Global
Select Market under the ticker symbol “ALXO” on July 17,
2020.
- Appointed Jeanne Jew as Chief Business
Officer. In August 2020, Jeanne Jew was appointed Chief
Business Officer of ALX Oncology. Ms. Jew brings to ALX Oncology
over 25 years of business development and commercial planning
experience in the biopharmaceutical industry, most recently serving
as Senior Vice President of Business Development of Paratek
Pharmaceuticals.
- Appointed New Director. In April 2020, Rekha
Hemrajani, was appointed to the Company's Board of Directors, and
serves as the Audit Committee chair and as a member of the
Corporate Governance and Nominating Committee. Ms. Hemrajani has
over 20 years of business development and financial expertise in
the biotechnology industry, and most recently served as President
and Chief Executive Officer at Aravive.
Recent Clinical Developments for ALX148
ALX148 is a next generation CD47 blocking therapeutic that
combines a high-affinity CD47 binding domain with an inactivated,
proprietary Fc domain.
- Opened Investigational New Drug (“IND”) Application for
ALX148 in combination with azacitidine for first-line treatment of
patients with higher risk myelodysplastic syndromes
(MDS): ALX Oncology submitted the IND in June 2020,
and the FDA issued a “Study May Proceed” letter in July 2020. The
Company expects patient enrollment to begin in the fourth quarter
of 2020.
- Presented Preliminary Phase 1 Study Results of ALX148
in Combination with Rituximab in Patients with Refractory
Non-Hodgkin Lymphoma. In June 2020, ALX Oncology presented
preliminary results from the fully enrolled ALX148 plus rituximab
combination cohort of the Phase 1 clinical program at the 25th
Annual Congress of European Hematology Association [abstract
#EP1247]. Thirty-three patients with relapsed or refractory
non-Hodgkin Lymphoma (NHL) were administered ALX148 at 10 or 15
mg/kg once per week in combination with standard rituximab regimen.
No exposure-dependent cytopenias were observed, and a greater
response rate was observed in the higher dosing cohort of heavily
pre-treated subjects with NHL.
- Presented Phase 1 Study Results of ALX148 in
Combination with Standard Anti-Cancer Antibodies and Chemotherapy
Regimens in Patients with Advanced Solid Tumors. In May
2020, ALX Oncology announced final results from the fully enrolled
ALX148 plus pembrolizumab and ALX148 plus trastuzumab portions of
the Phase 1 clinical trial at the 2020 American Society of Clinical
Oncology Annual Meeting [Abstract #3056]. Eighty-nine patients with
advanced solid tumors were administered ALX148 in combination with
standard regimens of: 1) pembrolizumab, 2) trastuzumab, 3)
pembrolizumab plus 5-fluorouracil plus platinum, or 4) trastuzumab
plus ramucirumab plus paclitaxel. Expansion cohorts were comprised
of patients with previously treated advanced head and neck squamous
cell carcinoma (HNSCC) and advanced gastric/gastroesophageal
junction cancer (G/GEJ) demonstrated objective responses. ALX148
displayed a favorable tolerability profile with no
exposure-dependent cytopenia observed across the dose range
evaluated. Preliminary data suggest that ALX148 can be combined
with chemotherapy-containing regimens with objective responses
observed in patients with HNSCC and G/GEJ disease. Future clinical
development will focus upon evaluating these combinations in
patients with previously untreated disease as well as later line
disease.
Second Quarter 2020 Financial Results:
- Cash and Cash Equivalents: Cash and cash
equivalents as of June 30, 2020, were $98.1 million. Including the
net proceeds from the Company’s IPO of $172.7 million, after
deducting underwriting discounts and commissions, the Company
believes its cash balance is sufficient to fund planned operations
through 2023.
- Related-party Revenue: Related-party revenue
for the quarter ended June 30, 2020, was $0.5 million compared to
$1.3 million for the corresponding period in 2019. The decrease
in related-party revenue relates to decreased
fee-for-service hours provided to Tallac Therapeutics (“Tallac”) as
a result of winding down the research and development agreement,
which terminated in July 2020. Due to the changes in the
arrangement with Tallac, the Company will no longer recognize any
related-party revenue beginning with the third quarter of
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 June 30, 2020, were $7.7 million, compared to $3.6 million
for the three months ended June 30, 2019. The increase of $4.0
million was primarily attributable to an increase of $2.3 million
in non-cash stock-based compensation expense, mainly resulting from
modification of awards for former employees that transferred to
Tallac, as well as increased clinical supply manufacturing costs of
$1.4 million and increased clinical development personnel costs of
$0.3 million.
- 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 June 30, 2020,
were $3.2 million, compared to $0.7 million for the prior-year
period. This increase of $2.5 million was primarily due to
increased headcount, and increased accounting, legal and other
professional fees of $1.4 million to support the transition to a
public company, and $0.6 million related to non-cash stock-based
compensation expense from the modification of awards for a former
employee that transferred to Tallac and additional stock option
awards granted during the second quarter.
- Net loss: Net loss attributable to common
stockholders was $14.0 million and $5.2 million for the three
months ended June 30, 2020, and 2019, respectively. Included in the
$14.0 million loss for the three months ended June 30, 2020, was
$2.6 million related to cumulative dividends allocated to preferred
shareholders, which, along with prior cumulative dividends, were
converted into common shares at the IPO. Non-GAAP net loss was $8.1
million and $4.1 million for the three months ended June 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 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 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 advance ALX148 into clinical development for the treatment of
myelodysplastic syndromes and to continue clinical development for
the treatment of a range of solid tumor indications.
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
the Company’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 the Company’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
the Company’s financial condition, results of operations and
sufficiency of its cash and cash equivalents to fund its planned
operations as well as statements about the Company’s expectations
regarding its progress and timing of clinical trials for ALX148,
including enrollment and its regulatory plans. These and other
risks are described more fully in the Company’s filings with the
Securities and Exchange Commission (“SEC”), including the Company’s
Quarterly Report on Form 10-Q, filed with the SEC on August 27,
2020, and other documents the Company subsequently files with the
SEC from time to time. Except to the extent required by law, the
Company 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 |
|
|
SIX MONTHS ENDED |
|
|
|
JUNE 30, |
|
|
JUNE 30, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Related-party revenue |
|
$ |
|
527 |
|
|
$ |
|
1,295 |
|
|
$ |
|
1,182 |
|
|
$ |
|
2,327 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
|
7,663 |
|
|
|
|
3,628 |
|
|
|
|
11,491 |
|
|
|
|
7,361 |
|
General and administrative |
|
|
|
3,172 |
|
|
|
|
679 |
|
|
|
|
4,645 |
|
|
|
|
1,267 |
|
Cost of services for related-party revenue |
|
|
|
479 |
|
|
|
|
1,177 |
|
|
|
|
1,075 |
|
|
|
|
2,115 |
|
Total operating expenses |
|
|
|
11,314 |
|
|
|
|
5,484 |
|
|
|
|
17,211 |
|
|
|
|
10,743 |
|
Loss from operations |
|
|
|
(10,787 |
) |
|
|
|
(4,189 |
) |
|
|
|
(16,029 |
) |
|
|
|
(8,416 |
) |
Interest expense |
|
|
|
(219 |
) |
|
|
|
- |
|
|
|
|
(434 |
) |
|
|
|
- |
|
Other expense, net |
|
|
|
(305 |
) |
|
|
|
- |
|
|
|
|
(298 |
) |
|
|
|
(2 |
) |
Loss before income taxes |
|
|
|
(11,311 |
) |
|
|
|
(4,189 |
) |
|
|
|
(16,761 |
) |
|
|
|
(8,418 |
) |
Income tax provision |
|
|
|
(20 |
) |
|
|
|
(8 |
) |
|
|
|
(24 |
) |
|
|
|
(17 |
) |
Net loss and comprehensive
loss |
|
|
|
(11,331 |
) |
|
|
|
(4,197 |
) |
|
|
|
(16,785 |
) |
|
|
|
(8,435 |
) |
Cumulative dividends allocated to
preferred stockholders |
|
|
|
(2,641 |
) |
|
|
|
(981 |
) |
|
|
|
(4,624 |
) |
|
|
|
(1,886 |
) |
Net loss attributable to common
stockholders |
|
$ |
|
(13,972 |
) |
|
$ |
|
(5,178 |
) |
|
$ |
|
(21,409 |
) |
|
$ |
|
(10,321 |
) |
Condensed Consolidated Balance Sheet
Data(unaudited)(Amount in thousands)
|
|
June 30,2020 |
|
|
December 31,2019 |
|
Assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
98,103 |
|
|
$ |
9,017 |
|
Total assets |
|
$ |
103,112 |
|
|
$ |
10,676 |
|
Total liabilities |
|
$ |
12,467 |
|
|
$ |
10,952 |
|
Convertible preferred stock |
|
$ |
175,043 |
|
|
$ |
70,363 |
|
Total stockholders’ deficit |
|
$ |
(84,398 |
) |
|
$ |
(70,639 |
) |
GAAP to Non-GAAP Reconciliation
(unaudited)(in thousands)
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
GAAP net loss, as reported |
|
$ |
(11,331 |
) |
|
$ |
(4,197 |
) |
|
$ |
(16,785 |
) |
|
$ |
(8,435 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
2,853 |
|
|
|
60 |
|
|
|
3,004 |
|
|
|
136 |
|
Accretion of term loan |
|
|
113 |
|
|
|
- |
|
|
|
221 |
|
|
|
- |
|
Mark-to-market adjustment on financial instruments |
|
|
308 |
|
|
|
- |
|
|
|
408 |
|
|
|
- |
|
Total adjustments |
|
|
3,274 |
|
|
|
60 |
|
|
|
3,633 |
|
|
|
136 |
|
Non-GAAP net loss |
|
$ |
(8,057 |
) |
|
$ |
(4,137 |
) |
|
$ |
(13,152 |
) |
|
$ |
(8,299 |
) |
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 diluted earnings per share, 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) accretion on
term loan 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 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
Grafico Azioni ALX Oncology (NASDAQ:ALXO)
Storico
Da Giu 2024 a Lug 2024
Grafico Azioni ALX Oncology (NASDAQ:ALXO)
Storico
Da Lug 2023 a Lug 2024