CoLucid Pharmaceuticals, Inc. (NASDAQ:CLCD) today reported
financial and operating results for the quarter ended September 30,
2016.
Corporate Highlights
In September 2016 CoLucid announced that it had completed its
first pivotal Phase 3 clinical trial of lasmiditan oral tablets,
SAMURAI, which was a randomized, double-blind, placebo-controlled
parallel group study designed to evaluate the efficacy and safety
of lasmiditan (100 mg and 200 mg) in comparison to placebo. Both
the 100 mg and 200 mg doses of lasmiditan were efficacious on
migraine headache pain freedom, the primary endpoint, and most
bothersome associated symptom freedom, the key secondary endpoint,
at the two-hour time point (p < 0.001). Both the primary and key
secondary endpoints of SAMURAI conform to the U.S. Food and Drug
Administration’s (“FDA”) draft Guidance for Industry, Migraine:
Developing Drugs for Acute Treatment, issued in October 2014.
Both the 100 mg and 200 mg doses of lasmiditan were also more
efficacious than placebo on headache pain relief at the two-hour
time point (p < 0.001), as a rescue medication on headache pain
freedom at the two-hour time point (p < 0.001 and p < 0.012),
in reducing migraine related disability at the two-hour time point
(p < 0.001) and in improving Patient Global Impression of Change
(p < 0.001). Lasmiditan was well tolerated with no significant
difference in cardiovascular adverse events in patients dosed with
lasmiditan versus placebo. SAMURAI is the first of two Phase 3
pivotal trials of lasmiditan, each being conducted under a Special
Protocol Assessment (“SPA”) - agreement with the FDA.
At the 5th European Headache and Migraine Trust International
Congress (“EHMTIC”) in September 2016, an interim update on
CoLucid’s Phase 3 long-term, open-label trial evaluating
lasmiditan, the GLADIATOR study was also presented by Dr. Uwe
Reuter, Department of Neurology and Director of the Headache
Center, Charité Universitätsmedizin Berlin. Migraine patients
who have completed SAMURAI, as well as CoLucid’s second Phase 3
pivotal trial, SPARTAN, have been eligible to enroll in GLADIATOR.
GLADIATOR is expected to enroll up to a total of 2,580 patients,
who will be randomized to receive 100 mg or 200 mg of lasmiditan,
and treat up to eight migraine attacks per month for one year.
For a more complete discussion of the SAMURAI trial results,
including discussion of treatment emergent adverse events and study
design as well as the full EHMTIC symposium presentations for
SAMURAI and GLADIATOR see http://investor.colucid.com.
On September 14, 2016 the Company closed a follow-on public
offering of shares of its common stock which resulted in the sale
of 3,737,500 shares of common stock at a price to the public of
$20.00 per share. The aggregate net proceeds received by the
Company from the offering were approximately $69.9 million, net of
underwriting discounts and commissions of approximately $4.6
million and approximately $0.3 million of offering expenses paid by
the Company.
“This quarter was transformative for CoLucid as SAMURAI
demonstrated that lasmiditan oral tablets, either 100 mg or 200 mg,
may become an important acute treatment for migraine,” said Thomas
P. Mathers, Chief Executive Officer. “Given that in SAMURAI,
lasmiditan demonstrated efficacy as a primary treatment,
successfully met the secondary endpoint as a rescue medication, and
was well tolerated even in a patient demographic rich with
cardiovascular risk factors and conditions, we are very encouraged
by the prospects of potentially offering migraine patients the
first new mechanism of action for acutely treating their migraines
in over twenty years. We believe our recently completed
follow-on public offering has afforded us the necessary capital to
potentially submit a New Drug Application (“NDA”) to the FDA for
lasmiditan in the first half of 2018, pending the outcome of our
SPARTAN Phase 3 clinical trial and other necessary development
activities.”
2016 Financial Results
The Company ended the third quarter of 2016 with cash, cash
equivalents, and investments of $100.2 million compared to $64.5
million at year-end 2015. The increase was due to the
follow-on public offering of 3.7 million shares of CoLucid common
stock which was completed in the third quarter of 2016 and
generated approximately $69.9 million in net proceeds to the
Company. The Company believes it has sufficient cash, cash
equivalents and available for sale securities to enable it to fund
the remainder of SPARTAN, a substantial portion of GLADIATOR, and
the submission of an NDA to the FDA for lasmiditan. The
Company also estimates that such funds will support its operating
expenses and capital expenditure requirements through at least the
second quarter of 2018.
Research and development expenses were approximately $10.5
million in the third quarter of 2016 compared to $5.8 million for
the third quarter of 2015. The increase in R&D
expense was primarily due to the increased costs associated with
the lasmiditan Phase 3 clinical program including GLADIATOR, which
began enrollment in October 2015 and SPARTAN which began enrollment
in May 2016.
General and administrative expenses were approximately $2.2
million in the third quarter of 2016 compared to $3.2 million for
the third quarter of 2015. The decrease in G&A expense is
due to a $1.2 million reduction in stock compensation expense
between the two periods.
Net loss attributable to common stockholders for the third
quarter of 2016 was $12.7 million, or $0.79 per share, compared to
$8.9 million, or $0.59 per share, for the third quarter of
2015.
About LasmiditanLasmiditan has been designed
for the acute treatment of migraine headaches in adults without the
vasoconstrictor activity associated with previous generations of
migraine therapies. It selectively targets 5-HT1F receptors
expressed in the trigeminal pathway. Lasmiditan has been
given the generic stem name “ditan,” which distinguishes it from
other drug classes, including triptans, the current standard of
care for migraine.
CoLucid is currently enrolling patients in a second pivotal
Phase 3 clinical trial of lasmiditan oral tablets, SPARTAN. The
objective of SPARTAN is to evaluate the safety and efficacy of
lasmiditan (50 mg, 100 mg and 200 mg) in comparison to placebo two
hours after dosing on freedom from migraine headache pain, which is
the primary endpoint, and on freedom from the most bothersome
associated symptom of migraine (nausea, phonophobia or
photophobia), which is the key secondary endpoint. SPARTAN is a
randomized, double-blind, placebo-controlled parallel group
study. The study is expected to treat a single migraine in up
to 2,226 migraine patients with lasmiditan at approximately 140
sites in the United States, United Kingdom and Germany.
CoLucid expects that migraine patients enrolled in SPARTAN will
include those who also have one or more cardiovascular risk
factors, stable cardiovascular disease or known coronary artery
disease (“CAD”). CoLucid has obtained an SPA agreement from the FDA
for SPARTAN. Top-line results from SPARTAN are expected in the
second half of 2017.
CoLucid is also currently enrolling patients in GLADIATOR, a
Phase 3 long-term, open-label trial of lasmiditan. GLADIATOR’s
objective is to evaluate the safety and efficacy of lasmiditan,
(both the 100 mg and 200 mg dose) as well as resource utilization,
functional outcomes and disability. Based on the results of
GLADIATOR, CoLucid intends to build an appropriate safety database
to support an NDA for lasmiditan. At the time of the NDA
submission, it is anticipated that there will be more than 15,000
patient exposures to lasmiditan in the entire clinical program.
About MigraineMigraine is the leading cause of
disability among neurological disorders in the United
States according to the American Migraine
Foundation. An estimated 36 million Americans suffer from
migraine. Migraine can be extremely disabling and costly,
accounting for more than an estimated $20 billion in
direct (e.g., doctor visits, medications) and indirect (e.g.,
missed work, lost productivity) expenses each year in the
United States.
About CoLucid Pharmaceuticals, Inc.CoLucid is
developing oral lasmiditan for the acute treatment of migraine
headaches in adults and intravenous lasmiditan for the acute
treatment of headache pain associated with migraine in adults in
emergency room and other urgent care settings.
Forward-Looking Statements
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to CoLucid’s
expectations for lasmiditan’s efficacy, clinical trial enrollment
goals and the timing of clinical trial results and future clinical
trials, and sufficiency of cash. Actual enrollment results, use of
cash and other developments may occur that differ materially from
those projected or implied in these forward-looking statements.
Factors that may cause such a difference include risks that
enrollment goals will not be met, trials may not be commenced or
successful or may take longer to complete than anticipated, and
projected cash needs and expected financial results may be
different. More information about the risks and uncertainties faced
by CoLucid are contained in its periodic reports filed with
the Securities and Exchange Commission. CoLucid disclaims any
intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
CoLucid Pharmaceuticals, Inc. |
Condensed Statements of Operations and
Comprehensive Loss |
(in thousands, except share and per share
data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
Three months
ended September
30, |
|
|
Nine months endedSeptember
30, |
|
|
|
|
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
10,509 |
|
|
$ |
5,777 |
|
|
$ |
35,709 |
|
|
$ |
13,534 |
|
General
and administrative |
|
|
2,211 |
|
|
|
3,219 |
|
|
|
6,491 |
|
|
|
6,049 |
|
Total
operating expenses |
|
|
12,720 |
|
|
|
8,996 |
|
|
|
42,200 |
|
|
|
19,583 |
|
Loss from
operations |
|
|
(12,720 |
) |
|
|
(8,996 |
) |
|
|
(42,200 |
) |
|
|
(19,583 |
) |
Other income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income, net |
|
|
63 |
|
|
|
46 |
|
|
|
206 |
|
|
|
73 |
|
Total
other income, net |
|
|
63 |
|
|
|
46 |
|
|
|
206 |
|
|
|
73 |
|
Net loss
before income tax expense |
|
|
(12,657 |
) |
|
|
(8,950 |
) |
|
|
(41,994 |
) |
|
|
(19,510 |
) |
Income
tax expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net
loss |
|
|
(12,657 |
) |
|
|
(8,950 |
) |
|
|
(41,994 |
) |
|
|
(19,510 |
) |
Gain on
extinguishment of convertible stock |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
4,798 |
|
Accretion
of redeemable preferred stock |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(12,553 |
) |
Net loss
attributable to common stockholders |
|
$ |
(12,657 |
) |
|
$ |
(8,950 |
) |
|
$ |
(41,994 |
) |
|
$ |
(27,265 |
) |
Per common share
information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
attributable to common stockholders, basic and diluted |
|
$ |
(0.79 |
) |
|
$ |
(0.59 |
) |
|
$ |
(2.70 |
) |
|
$ |
(3.27 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
|
16,057,462 |
|
|
|
15,153,135 |
|
|
|
15,543,386 |
|
|
|
8,336,147 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CoLucid Pharmaceuticals, Inc. |
Condensed Balance Sheets |
(in thousands, except share data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,2016 |
|
|
December 31,2015 |
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
83,540 |
|
|
$ |
27,978 |
|
Available
for sale securities (less than 1 year) |
|
|
16,641 |
|
|
|
36,530 |
|
Prepaid
expenses and other current assets |
|
|
769 |
|
|
|
809 |
|
Total
current assets |
|
|
100,950 |
|
|
|
65,317 |
|
Other assets |
|
|
21 |
|
|
|
21 |
|
Total
assets |
|
$ |
100,971 |
|
|
$ |
65,338 |
|
Liabilities |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
4,151 |
|
|
$ |
1,649 |
|
Accrued
expenses |
|
|
4,782 |
|
|
|
3,780 |
|
Total
current liabilities |
|
|
8,933 |
|
|
|
5,429 |
|
Deferred revenue |
|
|
1,500 |
|
|
|
1,500 |
|
Total
liabilities |
|
|
10,433 |
|
|
|
6,929 |
|
Commitments and
contingencies (note 7) |
|
|
|
|
|
|
|
|
Stockholders’
equity |
|
|
|
|
|
|
|
|
Common stock, $0.001
par value; 270,000,000 shares authorized; 19,236,480 and 15,153,135
shares issued and outstanding as of September 30, 2016
and December 31, 2015, respectively |
|
|
19 |
|
|
|
15 |
|
Additional paid-in
capital |
|
|
219,601 |
|
|
|
145,532 |
|
Accumulated other
comprehensive income (loss) |
|
|
7 |
|
|
|
(43 |
) |
Accumulated
deficit |
|
|
(129,089 |
) |
|
|
(87,095 |
) |
Total
stockholders’ equity |
|
|
90,538 |
|
|
|
58,409 |
|
Total
liabilities and stockholders’ equity |
|
$ |
100,971 |
|
|
$ |
65,338 |
|
|
|
|
|
|
|
|
|
|
CONTACT
Thomas Mathers
Chief Executive Officer
CoLucid Pharmaceuticals, Inc.
(857) 285-6494
Hans Vitzthum
Managing Director
LifeSci Advisors, LLC.
(212) 915-2568
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