Top-line data from pivotal PROMISE 1 study of
eptinezumab for migraine prevention on track to be announced 2Q
2017
Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a clinical-stage
biopharmaceutical company developing monoclonal antibody
therapeutics, today announced financial results for the first
quarter ended March 31, 2017, and provided a corporate update.
“During the first quarter we remained focused on eptinezumab,
our unique and potentially transformative migraine prevention
therapy. We are excited about eptinezumab’s clinical data to date
and believe that data from our PROMISE 1 Phase 3 pivotal clinical
trial, which we expect to announce later this quarter, will further
validate our deliberate approach to determining the ideal profile
and delivery for a CGRP targeted therapy,” said Randall C.
Schatzman, Ph.D., president and chief executive officer of Alder.
“We are increasingly confident that eptinezumab’s differentiated
delivery and clinical profile, if approved, has the potential to
meet a profound need for patients living with chronic and severe
frequent episodic migraine and effectively address the U.S. market
opportunity for eptinezumab IV, which we estimate to be as high as
$2 billion.”
Recent Corporate Highlights
Eptinezumab – Pivotal-stage novel monoclonal antibody targeting
the calcitonin gene-related peptide (CGRP) for the prevention of
migraine.
- Completed enrollment in the open label pivotal trial which was
commenced in December 2016 to evaluate the long-term safety and
tolerability of eptinezumab administered via infusion once every 12
weeks for one year in approximately 120 patients.
- Reported 48-week data from the Phase 2b trial evaluating
eptinezumab in patients with chronic migraine that continued to
demonstrate a safety and tolerability profile similar to placebo
and consistent with earlier studies.
- Presented additional data at the 69th Annual American Academy
of Neurology meeting from Alder’s eptinezumab program, including
additional positive data from the Phase 2b clinical trial of
eptinezumab for the prevention of chronic migraine and information
describing the rational design objectives and selection of
attributes that are important for supporting the desired clinical
profile of a migraine prevention therapy.
ALD1910 — Preclinical monoclonal antibody targeting
pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38), a
protein that is active in mediating the initiation of migraine.
Alder believes ALD1910 holds potential as a new preventive option
for migraine patients who have an inadequate response to
therapeutics directed at CGRP or its receptor
- The company continues to advance ALD1910 through IND-enabling
studies
Corporate
- Announced the appointment of Wendy L. Yarno, a distinguished
executive with more than 30 years of experience in the
pharmaceutical industry as a public company director and product
commercialization team leader, including 26 years with Merck &
Co. Inc., to Alder’s board of directors
- Filed a notice of appeal on March 31, 2017 with the European
Patient Office (EPO) with respect to the decision of the EPO
Opposition Division (OD) to maintain certain patent claims granted
to Teva Pharmaceuticals Industries, Ltd. (Labrys) that the company
believes were improperly granted by the EPO and upheld by the OD
and should be revoked in their entirety.
Upcoming Eptinezumab Milestones
- Report top-line 12 and 24 week data from the PROMISE 1
(PRevention Of
Migraine via Intravenous
eptinezumab Safety and Efficacy
1) study in second quarter of 2017. PROMISE 1 is the company's
ongoing Phase 3 pivotal clinical trial that is evaluating the
safety and efficacy of eptinezumab administered via infusion once
every 12 weeks in patients with frequent episodic migraine in the
United States. PROMISE 1 enrollment targeted approximately
800 patients.
- Present additional data at the 59th Annual Scientific Meeting
of the American Headache Society from Alder’s eptinezumab
program.
- Complete enrollment in the PROMISE 2
(PRevention Of
Migraine via Intravenous
eptinezumab Safety and Efficacy
2) study in the second half of 2017. PROMISE 2 is the company's
ongoing Phase 3 pivotal clinical trial that is evaluating the
safety and efficacy of eptinezumab administered via infusion once
every 12 weeks in patients with chronic migraine in the United
States. PROMISE 2 is targeting enrollment of approximately
1,050 patients.
First Quarter 2017 Financial Results
As of March 31, 2017, Alder had $289.6 million in cash and cash
equivalents, and short-term investments compared to $351.9 million
as of December 31, 2016.
Research and development expenses for the quarter ended March
31, 2017 totaled $90.7 million, compared to $27.6 million for the
same period in 2016. The increase in spending was driven by the
company’s continued investment in eptinezumab and primarily
consisted of an increase in manufacturing costs for commercial
readiness activities and drug supply in support of planned and
ongoing clinical trials, and an increase in clinical trial costs.
The company also had an increase in salaries and stock-based
compensation expenses resulting from an increase in research and
development headcount to support eptinezumab and other programs
under development.
General and administrative expenses for the quarter ended March
31, 2017 totaled $10.0 million, compared to $6.0 million for the
same period in 2016. The increases in spending were primarily due
to an increase in stock-based compensation expense and salaries
expense resulting from an increase in administrative headcount, and
an increase in professional fees and other administrative costs
primarily to support commercial readiness activities.
Net loss for the quarter ended March 31, 2017 totaled $100.3
million, or $2.00 per share, compared to net loss of $33.4 million,
or $0.76 per share on a fully-diluted basis, for the same period in
2016.
Conference Call and Webcast
Alder will host a conference call and live audio webcast today
at 5:00 p.m. ET to discuss these financial results and to provide a
business update. The live call may be accessed by dialing (877)
430-4657 for domestic callers or (484) 756-4339 for international
callers, and providing conference ID number 94734332. The webcast
and accompanying slides may be accessed from the Events &
Presentations page in the Investors section of Alder’s website
at www.alderbio.com and will be available for replay
following the call for 30 days.
About Alder BioPharmaceuticals, Inc.
Alder BioPharmaceuticals, Inc., is a clinical-stage
biopharmaceutical company that discovers, develops and seeks to
commercialize genetically engineered therapeutic antibodies with
the potential to meaningfully transform current treatment
paradigms. Alder's lead pivotal-stage product candidate,
eptinezumab, is being evaluated for migraine prevention.
Eptinezumab is a monoclonal antibody that inhibits calcitonin
gene-related peptide (CGRP), a protein that is active in mediating
the initiation of migraine. Alder is additionally evaluating
ALD1910, a preclinical product candidate also in development as a
migraine prevention therapy. ALD1910 is a monoclonal antibody that
inhibits pituitary adenylate cyclase-activating polypeptide-38
(PACAP-38), another protein that is active in mediating the
initiation of migraine. Clazakizumab, Alder's third program, is a
monoclonal antibody candidate that inhibits interleukin-6 and is
licensed to Vitaeris, Inc. For more information, please visit
http://www.alderbio.com.
Forward-Looking Statements
This press release contains forward-looking statements,
including, without limitation, statements relating to: Alder’s
belief that eptinezumab is a unique and potentially transformative
migraine prevention therapy; Alder’s approach to determining the
ideal profile and delivery for a CGRP targeted therapy; the
continued development and clinical, therapeutic and commercial
potential of eptinezumab and ALD1910; the availability of results
from clinical trials; the potential regulatory approval of
eptinezumab; the differentiated delivery and clinical profile of
eptinezumab; and future data presentations. Words such as “on
track,” “potential,” “transformative,” “excited,” “believe,”
“expect,” “will,” “validate,” “confident,” “meet,” “need,”
“address,” “opportunity,” “estimate,” “option,” “report,”
“present,” “complete,” or other similar expressions, identify
forward-looking statements, but the absence of these words does not
necessarily mean that a statement is not forward-looking. In
addition, any statements that refer to expectations, projections or
other characterizations of future events or circumstances are
forward-looking statements. The forward-looking statements in this
press release are based upon Alder's current plans, assumptions,
beliefs, expectations, estimates and projections, and involve
substantial risks and uncertainties. Actual results and the
timing of events could differ materially from those anticipated in
the forward-looking statements due to these risks and uncertainties
as well as other factors, which include, without limitation: risks
related to the potential failure of eptinezumab and ALD1910 to
demonstrate safety and efficacy in clinical testing; Alder's
ability to conduct clinical trials and studies of eptinezumab and
ALD1910 sufficient to achieve a positive completion; the
availability of data at the expected times; the clinical,
therapeutic and commercial value of eptinezumab and ALD1910; risks
and uncertainties related to regulatory application, review and
approval processes and Alder's compliance with applicable legal and
regulatory requirements; risks and uncertainties relating to the
manufacture of eptinezumab; Alder's ability to obtain and protect
intellectual property rights, and operate without infringing on the
intellectual property rights of others; the uncertain timing and
level of expenses associated with Alder’s development and
commercialization activities; the sufficiency of Alder's capital
and other resources; market competition; changes in economic and
business conditions; and other factors discussed under the caption
"Risk Factors" in Alder's Quarterly Report on Form 10-Q for the
quarterly period ended March 31, 2017, which was filed with the
Securities and Exchange Commission (SEC) on April 27, 2017, and is
available on the SEC's website at www.sec.gov. Additional
information will also be set forth in Alder's other reports and
filings it will make with the SEC from time to time. The
forward-looking statements made in this press release speak only as
of the date of this press release. Alder expressly disclaims
any duty, obligation or undertaking to release publicly any updates
or revisions to any forward-looking statements contained herein to
reflect any change in Alder's expectations with regard thereto or
any change in events, conditions or circumstances on which any such
statements are based.
Condensed
Consolidated Balance Sheets |
|
|
|
|
(Unaudited) |
|
|
|
|
(Amounts in
thousands) |
|
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2017 |
|
2016 |
|
|
|
|
|
|
Cash,
cash equivalents and investments |
$ |
289,564 |
|
$ |
351,867 |
|
Prepaid
expenses and other assets |
|
28,285 |
|
|
57,287 |
|
Total
assets |
$ |
317,849 |
|
$ |
409,154 |
|
|
|
|
|
|
Total
liabilities |
$ |
30,090 |
|
$ |
26,371 |
|
Total
stockholders’ equity |
|
287,759 |
|
|
382,783 |
|
Total
liabilities and stockholders’ equity |
$ |
317,849 |
|
$ |
409,154 |
|
Condensed Consolidated Statements of
Operations |
|
|
|
(Unaudited) |
|
|
|
|
(Amounts in
thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
|
|
|
Collaboration and
license agreements |
$ |
— |
|
|
$ |
— |
|
|
Operating
expenses |
|
|
|
|
Research
and development |
|
90,689 |
|
|
|
27,647 |
|
|
General
and administrative |
|
9,981 |
|
|
|
6,045 |
|
|
Total
operating expenses |
|
100,670 |
|
|
|
33,692 |
|
|
Loss
from operations |
|
(100,670 |
) |
|
|
(33,692 |
) |
|
Other
income, net |
|
342 |
|
|
|
329 |
|
|
Net
loss |
$ |
(100,328 |
) |
|
$ |
(33,363 |
) |
|
Net loss per share -
basic and diluted |
$ |
(1.99 |
) |
|
$ |
(0.76 |
) |
|
Weighted average number
of common shares used in net loss per share - basic and
diluted |
|
50,395,632 |
|
|
|
43,753,517 |
|
|
|
|
|
|
|
|
|
|
|
Media Contacts:
David Schull
Russo Partners, LLC
(212) 845-4271
david.schull@russopartnersllc.com
Investor Relations Contact:
David Walsey
Alder BioPharmaceuticals
(425) 408-8032
ir@alderbio.com
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