Cynapsus Therapeutics Reports 2011 Financial Results and Highlights Key Developments
Marketwire, March 26, 2022
TORONTO – Cynapsus Therapeutics Inc. (CTH: TSX-V), a specialty pharmaceutical company developing an improved dosing formulation of an approved drug used to treat the symptoms of Parkinson’s disease, today announced its results for the fourth quarter and fiscal year ended December 31, 2011. Unless specified otherwise, all amounts are in Canadian dollars.
“2011 was a successful year for Cynapsus with achievement of multiple significant milestones. In particular, the year was highlighted by the completion of the first human clinical trial for APL-130277, the announcement of findings from a global neurologist survey confirming market need for APL-130277, and the completion of the acquisition of Adagio Pharmaceuticals," said Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus. “Building on this success, we remain focused on the completion of a dose escalation study in the next 3 to 4 months, as well as preparations for an Investigational New Drug Application to the US FDA for a clinical BioEquivalence study later in the year. The BEQ study is the next critical de-risking milestone that we believe will drive significant shareholder value.”
Financial Highlights
• Cash and cash equivalents at December 31, 2021 of $294,812 (December 31, 2010: $193,484).
• Subsequent to year end, on March 9, 2012, the Company announced the completion of new debenture financing in aggregate principal amount of $1,075,865, for net proceeds of $936,000.
• Net loss of $2,847,247 for the year ended December 31, 2021 (December 31, 2010: Net loss of $1,439,782)
• Report 131,743,219 common shares outstanding at December 31, 2021 (December 31, 2010: 93,359,219).
Operational Highlights
The following achievements were made during the year:
Cynapsus Completed the First Human Volunteer Pilot Proof-of-Concept Clinical Trial For APL-130277. In the second half of the year, the Company initiated and completed the first human clinical trial for APL-130277. On January 10, 2012, subsequent to the year end, Cynapsus announced positive headline data from its recently completed human volunteer pilot proof-of-concept trial for APL-130277, a sublingual thin film strip formulation of apomorphine. The study showed a pharmacokinetic (PK) profile that compared favorably to injected apomorphine with a mean T-max of 25 minutes and good tolerability, and therefore confirms that APL-130277 has the potential to treat motor fluctuations or "off episodes" in Parkinson's disease. This was a significant milestone and de-risking event for the project.
Cynapsus Completed a Significant Neurologist Survey That Confirms the Need for Improved Administration of Parkinson’s Disease Acute Rescue Therapy. On December 8, 2011, the Company announced the results of a large survey of neurologists and movement disorder specialists in the United States, Europe, Japan, China and select countries in the Rest of the World. In total, 500 neurologists and movement disorder specialists were surveyed on their treatment of patients with Parkinson’s disease. Collectively, these professionals treat approximately 62,000 Parkinson’s patients per year with approximately 41.4% classified as mild-moderate in severity, 42.2% as moderate-severe, and 16.4% as severe. The results of this survey confirm and expand on the results of the smaller neurologist survey that was completed by the Company in July 2010. This global neurologist survey was necessary to further support the unmet medical need and calculation of the numbers of patients that would make up the larger target population.
Cynapsus Completed the Acquisition of Adagio Pharmaceuticals Ltd. Beginning in the second quarter, the Company took steps to acquire Adagio. On December 22, 2011, the Company announced the completion of the acquisition of Adagio. The agreement and the issuance of Common shares of Cynapsus as consideration pursuant to the agreement was approved by Cynapsus’ shareholders at a Special Shareholder Meeting held on November 30, 2011. The transaction received final approval of the Board of Directors of Cynapsus on December 15, 2011. The acquisition superseded and replaced the License Option Agreement dated July 22, 2022 entered into by Cynapsus and Adagio with respect to the intellectual property owned by Adagio concerning the world-wide APL-130277 patent rights and know-how. The APL-130277 patent rights and know how are critical to the Company’s long term objectives and ensures full ownership of those rights by the Company.
In addition, effective March 23, 2012, the Company granted stock options to acquire 4,675,000 common shares. The stock options were granted to officers, directors, employees and consultants of the Company at an exercise price equal to $0.10 per share and with an expiry of 5 years. Of the total, 950,000 stock options will be granted to each of Nathan Bryson (CSO) and Andrew Williams (COO/CFO), 700,000 to Albert Agro (CMO), 400,000 to Rochelle Stenzler (Chairperson), and 200,000 to each of Ronald Hosking (Director), Julia Levy (Director), Alan Torrie (Director) and Alan Ryley (Director).
The TSX Venture Exchange Inc. has not reviewed and does not accept responsibility for the adequacy or accuracy of this press release.
About Cynapsus Therapeutics
Cynapsus is a specialty pharmaceutical company developing an improved dosing formulation of an approved drug used to treat the symptoms of 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. 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.
Cynapsus’ lead drug candidate, APL-130277, is an easy-to-administer, fast-acting and oral reformulation of an approved drug, apomorphine, used to rescue patients from off episodes. Cynapsus is focused on rapidly maximizing the value of APL-130277 by completing pivotal studies in advance of a New Drug Application expected to be submitted in 2013 or 2014. The Company anticipates out-licensing to an appropriate pharmaceutical partner before such an application is submitted.
More information about Cynapsus (CTH: TSX-V) is available at www.cynapsus.ca and at the System for Electronic Document Analysis and Retrieval (SEDAR) at www.sedar.com.
Contact Information
Cynapsus Therapeutics
Anthony Giovinazzo
President and CEO
(416) 703-2449 x225
[email protected]
Andrew Williams
COO & CFO
(416) 703-2449 x253
[email protected]
Media contacts:
Russo Partners LLC
Ian Stone
(619) 528-2220
[email protected]
Robert E. Flamm, Ph.D.
(212)-845-4226
[email protected]
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of applicable Canadian securities legislation. 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 Cynapsus' current 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.
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