Cynapsus Therapeutics Inc. (TSX VENTURE:CTH)(OTCQX:CYNAF), a specialty
pharmaceutical company developing a convenient and easy to use sublingual (oral)
thin film strip for the acute rescue of "off" motor symptoms of Parkinson's
disease, today announced its results for the year ended December 31, 2013.
Unless specified otherwise, all amounts are in Canadian dollars.
Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus, stated:
"2013 was a pivotal year for Cynapsus. The year was highlighted by completion of
our CTH-103 study, which was funded by The Michael J. Fox Foundation for
Parkinson's Research, as well as the closing of a $7.3 million financing and the
conversion of $4 million of debt to equity. We are now focused on the completion
of the CTH-104 study, preparations for an Investigational New Drug Application
to the U.S. FDA, and planning for additional clinical studies later this year.
Interim results for the CTH-104 study will be announced shortly, with final
results expected within the next 15 to 30 days. We look forward to reporting our
progress."
Financial Highlights
-- Cash and cash equivalents on hand at December 31, 2013 of $2,289,046
(December 31, 2012: $50,401).
-- Subsequent to year end, in January, February and March 2014, 1,252,602
warrants were exercised to acquire 1,252,602 common shares for gross
proceeds of $725,496.
-- Net loss of $4,433,287 for the year ended December 31, 2013 (December
31, 2012: Net loss of $3,063,806).
-- Report 38,884,009 common shares outstanding at December 31, 2013
(December 31, 2012: 14,214,922 common shares).
Operational Highlights
The following achievements were made during 2013:
-- Cynapsus raised $6 million in a first closing of a short form prospectus
offering, exchanged $4 million of debt for equity, and completed a 10:1
share consolidation. On March 1, 2013, the Corporation announced that it
completed a first closing of a short form prospectus offering of units
for gross proceeds of $6,008,376. Concurrent with the closing of the
Offering, the Corporation and the holders of Series A to E debentures
agreed to convert $4,030,244 in debt for common shares and warrants. In
addition, the Corporation completed a share consolidation of the
Corporation's issued and outstanding common shares on the basis of one
(1) new common share for every ten (10) common shares issued and
outstanding.
-- Cynapsus raised $1.3 million in a second closing of a short form
prospectus offering. On March 21, 2013, the Corporation announced that
it completed a second closing of its short form prospectus offering of
units for gross proceeds of $1,309,160. Total gross proceeds from the
First Closing and the Second Closing of the Offering are equal to
$7,317,160.
-- Cynapsus announced the appointment of two new Directors to the Board. On
May 9, 2013, the Corporation announced that Tomer Gold, the current Vice
President, Research & Development of Dexcel Pharma ("Dexcel"), and Ilan
Oren, currently Vice President, Business Development at Dexcel, joined
its Board of Directors.
-- Cynapsus published a white paper on apomorphine for "Off" periods in
Parkinson's Disease and its alternative delivery development candidate
APL-130277. On May 15, 2013, the Corporation announced that it had
completed a white paper providing background clinical information on
apomorphine. The paper identifies the potential benefits of APL-130277,
the Corporation's proprietary, patented, sublingual thin-film strip
system, specifically its ability to deliver apomorphine to patients in a
more convenient and more well-tolerated manner.
-- Cynapsus began trading on the OTCQX International in the United States.
On July 18, 2013, the Corporation announced that its common shares were
approved for trading in the United States on the OTCQX ("OTCQX").
Trading commenced immediately on OTCQX under the symbol CYNAF. The
Corporation continues to trade on the TSX Venture Exchange under the
symbol CTH.
-- Cynapsus announced top-line data for the CTH103 clinical trial.
Subsequent to year end, on January 13, 2014, Cynapsus announced positive
top line data of the Comparative Biostudy (CTH-103) of APL-130277. The
CTH-103 study was planned as a three-dose active comparator, placebo-
controlled, randomized cross-over trial to examine the pharmacokinetic
profile of sublingual administered APL-130277 compared to the
subcutaneous injection of apomorphine in healthy volunteers. The 10mg
and 15mg APL-130277 sublingual thin-film strips were crossed over to 2mg
and 3mg subcutaneous injections. The intent in the CTH-103 study for the
third cohort was to compare the 25mg sublingual thin film strip to the
4mg subcutaneous injection, but this third cohort could not be dosed due
to the dose-limiting adverse events experienced with the 3mg
subcutaneous injection. The Corporation is currently conducting the
single arm, healthy volunteer pharmacokinetic study (CTH-104) to look at
the 25mg APL-130277 sublingual strip without a crossover to the
injection. Interim results will be announced shortly, with final results
expected within the next 15 to 30 days.
-- Cynapsus announced the appointment of Nan Hutchinson to the Board of
Directors. Subsequent to year end, on February 13, 2014, Cynapsus
announced the appointment of a new director, Nan Hutchinson, who has
more than twenty-five years of pharmaceutical experience spanning all
aspects of commercialization, including strategic planning, marketing,
business development, sales leadership, talent identification and
development.
Critical Next Steps
For development of APL-130277 in the United States, the Corporation will follow
the 505(b)(2) regulatory pathway. Specifically, the Corporation is pursuing the
reformulation of apomorphine from a subcutaneous injection to a convenient and
more tolerable and safe sublingual thin film strip. The drug being delivered
(apomorphine) is identical to the drug used in the injection, and its use will
be intended as an acute rescue therapy for Parkinson's patients experiencing
acute, intermittent hypomobility (i.e. "off" episodes) associated with advanced
Parkinson's disease, which is the description of the use of apomorphine in the
current US approved label.
The 505(b)(2) pathway will require that the Corporation provide statistically
sufficient clinical evidence that Parkinson's patients experience management of
their "off" episodes, as a result of delivery of apomorphine via the sublingual
thin film strip route. The primary end point will be based on changes in the
Unified Parkinson's Disease Rating Scale Part III (UPDRS III) movement score. In
addition, the Corporation will be required to provide in a separate study,
statistically sufficient clinical evidence that administering apomorphine via a
sublingual thin film route results in Parkinson's patients experiencing low to
no oral irritation as a result of multiple daily exposures to the drug for an
extended period.
To achieve this, the Corporation currently expects to complete the following
clinical studies:
1. CTH-105 Pilot Study. A pilot study in patients with Parkinson's disease
who are naive to the use of apomorphine and who experience at least one
daily "off" episode with a total duration of "off" in any 24-hour period
of at least 2 hours. This study is planned to examine the effect of APL-
130277 on relieving "off" episodes over a single day with a dose-
titration used to determine dose strengths necessary for future clinical
development. The CTH-105 study is expected to begin in mid-2014
subsequent to the acceptance of an Investigational New Drug (IND)
application by the FDA. CTH-105 is expected to be completed by the end
of Q3 2014.
2. CTH-200 Bridging Study. A single dose, crossover comparative
bioavailability and PK study in healthy volunteers. This study is
designed to provide the clinical "bridge" to the FDA's finding of safety
and efficacy for the Reference Listed Drug (s.c. Apomorphine). The CTH-
200 Bridging Study is expected to begin in mid-2014 subsequent to
completion of CTH-105. It is expected to be complete by end of Q3 2014
and is required under the FDA's 505(b)(2) regulations to demonstrate
comparability to the reference listed drug.
3. CTH-300a Efficacy Study in apomorphine naive patients. A double-blind,
placebo-controlled, parallel-design study with Parkinson's patients who
have at least one "off" episode every 24 hours, with total "off" time of
at least 2 hours. The primary end point will be the change in the UPDRS
III score.
4. CTH-300b Efficacy Study in apomorphine experienced patients. A double
blind, placebo controlled, crossover-designed study with Parkinson's
patients who are presently controlled with the use of apomorphine. The
primary end point will be the change in the UPDRS III score. Upon
successful completion of CTH-300a and CTH-300b, the Corporation will
provide the results to the FDA and request a meeting to seek final
guidance for the design of Safety Study (CTH-301).
5. CTH-301 Safety Study. A long-term safety study in apomorphine naive
Parkinson's patients who have at least one "off" episode every 24 hours,
with total "off" time of at least 2 hours. The Safety Study is expected
to start in early 2015 and be completed by the end of 2015. The study
will specifically look at the safety and tolerability of the new
delivery route over a minimum period of 16 weeks.
The above clinical development plan has been vetted with both clinical experts
and regulatory consultants who have expertise in overseeing FDA 505(b)(2)
submissions to the Agency.
In parallel to the studies described above, the Corporation will be performing
the necessary scale-up, process validation and stability as part of the
Chemistry, Manufacturing and Controls ("CMC") requirements for the filing of the
NDA. Accordingly, all development will be performed according to current Good
Manufacturing Practices ("cGMP") methodology.
Upon completion of the efficacy and safety studies, as well as the CMC section,
the Corporation expects to begin the preparation of a FDA 505(b)(2) NDA in 2016.
About Cynapsus Therapeutics
Cynapsus is a specialty pharmaceutical company developing a convenient and easy
to use sublingual (oral) thin film strip for the acute rescue of "off" motor
symptoms of Parkinson's disease. Cynapsus' drug candidate, APL-130277, is an
easy-to-administer, fast-acting reformulation of apomorphine, which is the only
approved drug (in the United States, Europe, Japan and other countries) to
rescue patients from "off" episodes. Cynapsus is focused on maximizing the value
of APL-130277 by completing pivotal studies in advance of a New Drug Application
("NDA") expected to be submitted in 2016.
Over one million people in the U.S. and an estimated 4 to 6 million people
globally suffer from Parkinson's disease. Parkinson's disease is a chronic and
progressive neurodegenerative disease that impacts motor activity, and its
prevalence is increasing with the aging of the population. Based on a recent
study and the results of the Company's Global 500 Neurologists Survey, it is
estimated that between 25 percent and 50 percent of patients experience "off"
episodes in which they have impaired movement or speaking capabilities. Current
medications only control the disease's symptoms, and most drugs become less
effective over time as the disease progresses.
More information about Cynapsus (TSX VENTURE:CTH)(OTCQX:CYNAF) is available at
www.cynapsus.ca and at the System for Electronic Document Analysis and Retrieval
(SEDAR) at www.sedar.com.
Forward Looking Statements
This announcement contains "forward-looking statements" within the meaning of
applicable securities laws. Generally, these forward-looking statements can be
identified by the use of forward-looking terminology such as "plans", "expects"
or "does not expect", "is expected", "budget", "scheduled", "estimates",
"forecasts", "intends", "anticipates" or "does not anticipate", or "believes" or
variations of such words and phrases or state that certain actions, events or
results "may", "could", "would", "might" or "will be taken", "occur" or "be
achieved". Forward-looking statements are subject to known and unknown risks,
uncertainties and other factors that may cause the actual results, level of
activity, performance or achievements of Cynapsus to be materially different
from those expressed or implied by such forward-looking statements, including
but not limited to those risks and uncertainties relating to Cynapsus' business
disclosed under the heading "Risk Factors" in its latest Annual Information Form
and its other filings with the various Canadian securities regulators which are
available online at www.sedar.com. Although Cynapsus has attempted to identify
important factors that could cause actual results to differ materially from
those contained in forward-looking statements, there may be other factors that
cause results not to be as anticipated, estimated or intended. There can be no
assurance that such statements will prove to be accurate, as actual results and
future events could differ materially from those anticipated in such statements.
Accordingly, readers should not place undue reliance on forward-looking
statements. Cynapsus does not undertake to update any forward-looking
statements, except in accordance with applicable securities laws.
Neither of the TSX Venture Exchange or OTCQX has approved or disapproved the
contents of this press release.
FOR FURTHER INFORMATION PLEASE CONTACT:
Cynapsus Therapeutics Inc.
Anthony Giovinazzo
President and CEO
(416) 703-2449 x225
ajg@cynapsus.ca
Cynapsus Therapeutics Inc.
Andrew Williams
COO & CFO
(416) 703-2449 x253
awilliams@cynapsus.ca
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