Cynapsus Therapeutics Reports Second Quarter 2016 Financial Results and Recent Developments
(Thomson Reuters ONE) -
- Recent Positive Dose Titration Data from Pivotal Phase 3 Clinical Program -
- On Track for New Drug Application Submission in the First Half of 2017 -
TORONTO, Aug. 10, 2016 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics Inc.
(NASDAQ:CYNA) (TSX:CTH), a specialty central nervous system pharmaceutical
company developing and preparing to commercialize a fast-acting, easy-to-use,
sublingual thin film for the on-demand management of debilitating OFF episodes
associated with Parkinson's disease (PD), today reported financial results for
the quarter ended June 30, 2016 and provided an update on its product candidate
and corporate activities. Unless specified otherwise, all amounts are in United
States (U.S.) dollars.
"Recent positive results from the dose titration phase of our pivotal Phase 3
study signify our progress toward concluding our Phase 3 clinical program for
APL-130277," stated Anthony Giovinazzo, President and CEO of Cynapsus. "These
positive interim data have given us confidence that our approach to treating OFF
episodes will be successful. We expect to conclude the efficacy portion of the
Phase 3 trial soon and announce top-line data late in the third quarter or early
in the fourth quarter of this year. In addition, we look forward to sharing
longer-term safety data in the first half of 2017 and we intend to file our NDA
with the U.S. FDA in the first half of 2017."
Recent Business Highlights
* Appointment of Frederick Driscoll to Board of Directors: On May 20, 2016,
Cynapsus announced the appointment of Frederick W. Driscoll to its board of
directors. Mr. Driscoll has more than 30 years of financial management
experience with biotechnology and medical device companies. Mr. Driscoll is
currently the chairman of the board of OXiGENE, Inc., and is also currently
the chief financial officer at Flexion Therapeutics. He is serving on
Cynapsus' audit committee.
* European Academy of Neurology Annual Meeting (EAN): In May 2016, Cynapsus
attended the EAN in Copenhagen and presented three poster presentations.
Clinical data from a toxicology study in Hamsters showed that APL-130277
produced no buccal mucosal irritation. An Evaluation of Physician Practices
showed that physicians feel there is a high level of unmet need regarding
treatment options for OFF episodes. In addition, an Evaluation of Patient
and Caregiver Insights shared that OFF episodes negatively impact quality of
life for PD patients. The posters can be found in the product pipeline
section under publications on the Cynapsus website www.cynapsus.ca.
* International Congress of Parkinson's Disease and Movement Disorders
(ICPDMD): In June 2016, Cynapsus attended the ICPDMD in Berlin and presented
seven posters. Four new presentations included (1) Physician primary
research showing that the effective dose of APL-130277 converting patients
to full ON from OFF is not correlated with commonly used measures, that
disease severity is not predictive of the effective APL-130277 dose, and
data suggests titrating patients from the lowest possible APL-130277 dose,
(2) Patient/Caregiver primary research reported that OFF episodes have a
negative impact on quality of life and that patients are open to new
treatments, (3) An evaluation of physician practices noted that physicians
believe there is a high unmet need for new treatment options for OFF
episodes, (4) A Hamster mucosal toxicology study of APL-130277 showed the
product candidate produced no irritation of the cheek pouch when
administered at a relatively high dose over 28 days.
Three encore presentations displayed (1) APL-130277 converted patients from
OFF to ON regardless of demographics or disease characteristics (2)
Pharmacokinetic/Pharmacodynamic of APL-130277 confirmed, on average, that a
minimum apomorphine plasma concentration of 2.64 ng/ml was needed to turn a
patient to full ON from the OFF state, and (3) The Movement Disorder
Society's Uniform Parkinson's Disease Rating Scale Part III (MDS-UPDRS)
improvement of over 10 points and a change of 20% at 15 minutes post-APL-
130277 dose was needed to turn a PD patient from morning OFF to the full ON
state. The posters can be found in the product pipeline section under
publications on the Cynapsus website www.cynapsus.ca.
* Announcement of Enrollment of Last Patient in Pivotal Phase 3 Efficacy Trial
of APL-130277: On June 30, 2016, Cynapsus announced that the last patient
was enrolled in the Phase 3 Efficacy trial, CTH-300, a double-blind,
placebo-controlled, parallel-design study with PD patients who have at least
one OFF episode every 24 hours, with total OFF time of at least two hours
per day.
* Announcement of Positive Phase 3 Dose Titration Results from Efficacy Trial
of APL-130277: At Cynapsus' Analyst and Investor Day on July 19, 2016, the
Company detailed positive preliminary open-label dose titration (DTP)
results. Data showed the mean change in MDS-UPDRS from baseline to 30
minutes was 22 points. In addition, 60% of patients' improvement in motor
function was reported between 5-12 minutes after dosing and was maintained
beyond 90 minutes. Furthermore, 83% of patients entering DTP turned from OFF
to fully ON, 78% turned fully ON within 30 minutes and approximately 38%
were fully ON at 15 minutes. The median dose of APL-130277 turning patients
to fully ON was 20mg, and the product candidate was well tolerated by
patients. Sixteen percent of patients reported mild to moderate nausea, 8%
reported dizziness, 4% reported somnolence, 2% reported vomiting and 1%
reported symptomatic hypotension. There were no reports of local
irritation. Sixteen patients were dosed but did not complete the DTP; five
discontinued due to an adverse event, nine discontinued due to the highest
dose not effectively turning them from OFF to ON within 45 minutes and two
discontinued for administrative reasons.
* Announcement of European Clinical Plan Update for APL-130277: On July
18, 2016, Cynapsus provided an update on its European clinical plan for APL-
130277 following meetings with regulatory authorities. Cynapsus plans to
conduct an active comparator study with sub-cutaneous apomorphine with up to
80 patients randomized in a four-week open label crossover study. Functional
endpoints will be assessed and include the duration of ON, preference and
ease-of-use of APL-130277, the use of patient diaries and the tolerability
of APL-130277.
Upcoming Milestones and Events
United States
* World Parkinson Congress: Cynapsus will conduct a corporate symposium on "A
Practical Approach to the Management of OFF periods in PD," on September
22(nd) in Portland, Oregon
* CTH-300 Phase 3 Efficacy Study: Top-line data expected late in the third
quarter or early in the fourth quarter of 2016
* CTH-301 Phase 3 Safety Study: Top-line data expected in the first half of
2017
* CTH-201 Phase 2 Thorough QT Study: Subject to FDA review and agreement, if
required, this study is planned to begin in the second half of 2016. If
commenced, the trial is expected to be completed in the fourth quarter of
2016 or the first quarter of 2017
* New Drug Application(NDA)submission: An NDA is expected to be submitted to
the FDA in the first half of 2017
European Union
* CTH-302 European Registration Study: An active comparator study is expected
to commence in the fourth quarter of 2016
Q2 2016 Financial Results
* Cash. Cash as of June 30, 2016, totaled $55.1 million as compared to $68.6
million as of March 31, 2016. Cash used in operating activities for the six
months ended June 30, 2016 was $15.9 million versus $10.8 million for the
six months ended June 30, 2015. Cynapsus expects its cash as of June
30, 2016 to be sufficient to fund the Company into 2017.
* R&D Expense. Research and development expenses were $7.2 million for the
three months ended June 30, 2016, compared to $6.8 million for the three
months ended June 30, 2015, an increase of $0.4 million. For the six months
ended June 30, 2016, R&D expense was $12.4 million, compared to $9.2 million
for the six months ended June 30, 2015.
* OG&A Expense. Operations, general and administrative expenses were $2.7
million for the three months ended June 30, 2016, compared to $2.5 million
for the three months ended June 30, 2015, an increase of $0.2 million. For
the six months ended June 30, 2016, OG&A expense was $5.8 million, compared
to $4.1 million for the six months ended June 30, 2015.
* Loss for the Period. For the three months ended June 30, 2016, loss for the
period was $10.2 million, or $0.83 per share, as compared to loss for the
period of $8.9 million, or $1.22 per share, for the three months ended June
30, 2015. For the six months ended June 30, 2016, loss for the period was
$18.5 million, or $1.51 per share, as compared to loss for the period of
$13.0 million, or $2.07 per share, for the six months ended June 30, 2015.
* Reported common shares outstanding as of June 30, 2016 were 12,321,566
common shares as compared to 12,309,366 common shares as of March 31, 2016.
Cynapsus Therapeutics Inc.
Interim Statements of Loss and Comprehensive Loss
(unaudited)
(in millions and in US dollars, except per share data)
For the Three Months Ended For the Six Months Ended
June 30, June 30,
-------------------------------- --------------------------------------
2016 2015* 2016 2015*
---------------- --------------- ------------------ -----------------
EXPENSES
Research and
development $ 7,152 $ 6,830 $ 12,371 $ 9,183
Operating,
general and
administrative 2,701 2,546 5,842 4,051
Acquisition
milestone
share-based
payment - - - 1,209
Unrealized
foreign
exchange gain (10 ) (458 ) (14 ) (1,411 )
Interest
income and
related
charges 331 (5 ) 331 (12 )
---------------- --------------- ------------------ -----------------
Loss for the
period 10,174 8,913 18,530 13,020
Other
comprehensive
loss
Foreign
currency
translation
adjustment - 192 - 1,494
---------------- --------------- ------------------ -----------------
Loss and other
comprehensive
loss for the
period $ 10,174 $ 9,105 $ 18,530 $ 14,514
---------------- --------------- ------------------ -----------------
Loss per
share - basic
and diluted $ 0.83 $ 1.22 $ 1.51 $ 2.07
Weighted
average number
of shares
outstanding
- basic and
diluted 12,315,869 7,316,076 12,303,454 6,280,674
Cynapsus Therapeutics Inc.
Interim Statements of Financial Position
(unaudited)
(in millions and in US dollars)
December
June 30, 31,
2016 2015
----------- ------------
$ $
ASSETS
Current assets
Cash 55,068 75,803
Prepaid expenses and other current assets 1,082 629
----------- ------------
Total current assets 56,150 76,432
Non-current assets
Property, plant and equipment 473 409
Intangible assets 16,273 3811
----------- ------------
Total assets 72,896 77,221
----------- ------------
LIABILITIES
Current liabilities
Accounts payable and accrued liabilities 4,395 3,799
Current portion of license payable 8,243 -
----------- ------------
Total current liabilities 12,638 3,799
Long-term liabilities
Long-term portion of license payable 2,997 -
----------- ------------
Total long-term liabilities 2,997 -
----------- ------------
Total liabilities 15,635 3,799
----------- ------------
SHAREHOLDERS' EQUITY
Share capital 120,024 119,565
Warrants 10,485 10,623
Share-based payments 8,380 6,333
Deficit (70,962 ) (52,433 )
Accumulated other comprehensive loss (10,666 ) (10,666 )
----------- ------------
Total shareholders' equity 57,261 73,422
----------- ------------
Total liabilities and shareholders' equity 72,896 77,221
----------- ------------
*Certain comparative figures have been reclassified to conform to the financial
statement presentation adopted for the current period and all amounts prior to
January 1, 2016 have been restated for the change in reporting currency from
Canadian dollars to U.S. dollars.
About Cynapsus
Cynapsus is a specialty central nervous system pharmaceutical company developing
and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film
for the on-demand management of debilitating OFF episodes associated with PD.
The Company has successfully completed a Phase 2 clinical trial for its product
candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or
apomorphine. Apomorphine is the only molecule approved for acute, intermittent
treatment of OFF episodes for advanced PD patients, but is currently only
approved as a subcutaneous injection in the United States. APL-130277 is a
"turning ON" medication designed to rapidly, safely and reliably convert a PD
patient from the OFF to the ON state while avoiding many of the issues
associated with subcutaneous delivery of apomorphine. It is designed to convert
all types of OFF episodes, including morning OFF episodes, often considered the
most difficult to treat. Cynapsus has initiated its Phase 3 clinical program for
APL-130277, relying on the abbreviated Section 505(b)(2) regulatory pathway in
the United States, and the Company intends to submit an NDA in the first half of
2017. For additional company information, please visit our website
at www.cynapsus.ca. For more information about the Phase 3 studies, including
enrollment criteria, please visit the following
website: http://cth300and301trials.cynapsus.ca/
Forward-Looking Statements
This announcement contains "forward-looking statements" within the meaning of
applicable securities laws, including, without limitation, the Company's
expectation for filing an NDA in the first half of 2017; expectations regarding
the Company's clinical and regulatory activities, including without limitation,
the anticipated timing, completion and results of Phase 3 and other clinical
studies; beliefs related to potential benefits and effectiveness of, and demand
for, the Company's product candidate; and expectations regarding the sufficiency
of the Company's cash. These forward-looking statements include information
about possible or assumed future results of the Company's business, financial
condition, results of operations, liquidity, plans and objectives. In some
cases, you can identify forward-looking statements by terminology such as
"believe," "may," "estimate," "continue," "anticipate," "intend," "should,"
"plan," "expect," "predict," "potential," or the negative of these terms or
other similar expressions. These forward-looking statements are based on the
Company's current expectations and beliefs and inherently involve significant
risks and uncertainties. Actual results and the timing of events could differ
from those anticipated in such forward-looking statements as a result of risks
and uncertainties, and include, but are not limited to, those factors identified
under the caption "Risk Factors" in the Company's Form 10-Q filed with the
United States Securities and Exchange Commission (the "SEC") on August
10, 2016, and its other filings and reports in the United States with the SEC
available on the SEC's web site at www.sec.gov, and in Canada with the various
Canadian securities regulators, which are available online at www.sedar.com.
Furthermore, unless otherwise stated, the forward-looking statements contained
in this press release are made as of the date of this press release, and the
Company has no intention and undertakes no obligation to update or revise any
forward-looking statements, whether as a result of new information, future
events, changes or otherwise, except as required by law.
Neither the NASDAQ nor the TSX has approved or disapproved of the contents of
this press release.
Contact Information
Cynapsus
Kristen Galfetti
Vice President Investor Relations
(416) 703-2449 x246
kgalfetti(at)cynapsus.ca
Media Contact:
Russo Partners LLC
Matt Middleman
(212) 845-4272
matt.middleman(at)russopartnersllc.com
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Cynapsus Therapeutics Inc. via GlobeNewswire
[HUG#2034462]
Unternehmensinformation / Kurzprofil:
Datum: 10.08.2016 - 22:10 Uhr
Sprache: Deutsch
News-ID 488475
Anzahl Zeichen: 21543
contact information:
Town:
Toronto, Ontario
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 206 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Cynapsus Therapeutics Reports Second Quarter 2016 Financial Results and Recent Developments"
steht unter der journalistisch-redaktionellen Verantwortung von
Cynapsus Therapeutics Inc. (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
