TORONTO, Sept. 15, 2015 /CNW/ - Transition
Therapeutics Inc. ("Transition" or the "Company") (TSX: TTH;
NASDAQ: TTHI), a biopharmaceutical development company advancing
novel therapeutics for CNS and metabolic disease indications, today
announced its financial results for the year ended June 30, 2015. Investors are invited to
participate in a conference call today at 4:30pm EST to discuss these
results. Dial in information for the call is as follows:
(800) 750-5849 (North America) and
(416) 981-9035 (International). A live webcast can be
accessed via Transition's website www.transitiontherapeutics.com,
with a replay available for seven days following the call.
Selected Highlights
Highlights for the Company during the year ended June 30, 2015 and up to the date of this press
release include the following:
ELND005:
- June 24, 2015 – Transition
announced results of Clinical Study of ELND005 in
Agitation and Aggression in Patients with Alzheimer's
Disease. The Phase 2/3 clinical study of neuropsychiatric
drug candidate ELND005 did not meet its primary efficacy endpoint.
In the study, both the treatment and placebo groups showed a
significant, but similar, reduction in agitation and aggression
relative to baseline. There was a greater than expected reduction
in agitation and aggression observed in the placebo group as
measured in weeks 4, 8 and 12 in the study. The safety and
tolerability profile of ELND005 was consistent with previous
studies in AD at the 250mg bid dose;
- March 26, 2015 – Transition
announced results from two phase 1 clinical studies of
neuropsychiatric drug candidate ELND005. These studies, an
absorption-metabolism-excretion ("AME") study and a renal clearance
study, are specialized clinical pharmacology trials that are
required by the United States Food and Drug Administration ("FDA")
for the approval of most drugs in development;
- November 24, 2014 –
Transition announced results from a thorough QT (tQT) study in
which no QT effects were observed at supra-therapeutic single doses
of neuropsychiatric drug candidate, ELND005. A tQT study is
a specialized clinical trial required by the FDA for the approval
of most drugs in development. From a safety perspective, drugs that
have no QT prolongation effects are particularly desirable for
administration to an elderly AD population;
- November 20, 2014 –
Transition announced the results of a clinical study of
neuropsychiatric drug candidate ELND005 in young adults with Down
syndrome. TTIL completed this first study in Down syndrome
subjects without dementia to allow optimal dose selection for
future larger studies. The study enrolled 23 Down syndrome subjects
in three study arms over a four-week treatment period. At the doses
evaluated, ELND005 was determined to have an acceptable safety and
tolerability profile and there were no serious adverse events
reported;
- November 4, 2014 –
Transition announced findings from a Phase 2 study of
neuropsychiatric drug candidate, ELND005, as an adjunctive
maintenance treatment for bipolar disorder type I patients
(BPD). TTIL terminated the bipolar disorder Phase 2 study
on April 7, 2014 for business
reasons. TTIL has completed a review of the data from this bipolar
disorder Phase 2 study. Overall, ELND005 had an acceptable safety
and tolerability profile in the study, and showed numerical
differences in the number of mood event recurrences favoring
ELND005.
TT401:
- In February, 2015, development partner Lilly informed
Transition that 420 type 2 diabetic subjects have been enrolled in
the current Phase 2 study thereby completing the enrollment phase
of the study;
- Transition has paid all three installment payments
totaling US$14 million to
diabetes drug candidate development partner Lilly.
Transition has no further financial obligations for the development
and commercialization of TT401.
TT401 (LY2944876) is an oxyntomodulin analogue that has dual
agonist activity of the GLP-1 (Glucagon-Like Peptide-1) and
glucagon receptors. A Phase 2 clinical trial of TT401 in
type 2 diabetes subjects is being performed by Transition's
development partner, Lilly.
Transition is eligible to receive up to approximately
US$240 million in additional
milestone payments plus double-digit royalties on sales of TT401
products and a low single digit royalty on sales of related
compounds.
Corporate Developments:
- June 16, 2015 – Transition
announced that Carl Damiani has been
appointed as President and Chief Operating Officer of
Transition;
- May 6, 2015 – Transition
announced its wholly-owned subsidiary, TTIL has exclusively
licensed worldwide rights to a novel small molecule drug candidate
("TT701") from Eli Lilly and Company. Under the terms of
the agreement, TTIL has acquired rights to develop and
commercialize TT701. Lilly will receive upfront consideration of up
to US$1 million. In addition, Lilly
is eligible to receive up to US$100
million in commercial milestones and a mid-single digit
royalty on sales of TT701 products should such products be
successfully commercialized. TT701 is a selective androgen receptor
modulator that has been shown in a Phase 2 study to significantly
increase lean body mass and a measurement of muscle strength in
male subjects. This completed 12-week, Phase 2 study of 350
subjects also demonstrated additional beneficial effects, including
significant fat mass reduction with no significant change in
prostate specific antigen (PSA) levels. TTIL is evaluating multiple
development paths for TT701, including as a new therapeutic option
for patients with androgen deficiency. TTIL is engaged with
potential collaborators to rapidly commence a Phase 2 clinical
study;
- February 18, 2015 –
Transition announced the closing of a public offering of
US$23 million of common shares
equivalent to an aggregate of 3,538,461 common shares at a price to
the public of US$6.50 per share,
including 461,538 common shares issued upon the exercise of the
underwriters' over-allotment option. Cowen and Company, LLC
was the sole book-running manager and Canaccord Genuity Inc.,
H.C. Wainwright & Co., LLC, and
LifeSci Capital LLC were the co-managers for the offering.
Financial Liquidity
At June 30, 2015, the Company had
cash resources of $40,510,758 and a
working capital of $32,026,606.
The Company's current cash projection indicates that the
existing cash resources should enable the Company to execute its
core business plan and meet its projected cash requirements beyond
the next 12 months.
Financial Review
During the year ended June 30,
2015, the Company recorded a net loss of $51,339,528 ($1.41
loss per common share) compared to a net loss of $21,782,255 ($0.72
loss per common share) for the year ended June 30, 2014.
Research and Development
Research and development expenses increased $31,842,318 or 183% from $17,367,385 for the fiscal year ended
June 30, 2014 to $49,209,703 for the fiscal year ended
June 30, 2015.
The increases in research and development expenses are primarily
due to increases in development costs related to ELND005. The
increases are also attributed to increases in development costs
associated with diabetes drug candidate TT401 as during fiscal 2015
the Company paid Lilly an aggregate of US$14
million upon the achievement of all three patient enrollment
milestones. The increase in research and development costs have
been partially offset by decreases in clinical development costs
associated with the costs related to the TT601 program.
General and Administrative
General and administrative expenses increased by $787,698 or 17% from $4,726,574 for the fiscal year ended June 30, 2014 to $5,514,272 for the fiscal year ended June 30, 2015.
The increases in general and administrative expenses are
primarily due to increases in compensation and overhead costs
relating to the Company's premises in San
Mateo, California.
About Transition
Transition is a biopharmaceutical development company, advancing
novel therapeutics for CNS and metabolic disease indications. The
Company's wholly-owned subsidiary, Transition Therapeutics Ireland
Limited is developing CNS drug candidate ELND005 for the treatment
of Alzheimer's disease and Down syndrome. Transition's lead
metabolic drug candidate is TT401 for the treatment of type 2
diabetes and accompanying obesity. The Company's shares are listed
on the NASDAQ under the symbol "TTHI" and the Toronto Stock
Exchange under the symbol "TTH". For additional information about
the Company, please visit www.transitiontherapeutics.com.
Extracts of the Financial Statements to Follow:
CONSOLIDATED
BALANCE SHEETS
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In Canadian
Dollars
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June 30,
2015
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June 30,
2014
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Assets
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Current
assets
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Cash
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40,510,758
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57,212,004
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Short term
investments
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-
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3,059,562
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Other
receivables
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265,189
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220,514
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Income tax and
investment tax credits receivable
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399,668
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|
212,393
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Prepaid expenses and
deposits
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259,143
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36,656
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41,434,758
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60,741,129
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Non-current
assets
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Property and
equipment
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191,944
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158,926
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Intangible
assets
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8,022,383
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8,007,181
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Total
assets
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49,649,085
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68,907,236
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Liabilities
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Current
liabilities
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Trade and other
payables
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8,549,895
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5,963,258
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Contingent
consideration payable
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858,257
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-
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9,408,152
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5,963,258
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Non-current
liabilities
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Contingent
consideration payable
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3,503,344
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3,838,286
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Leasehold
inducement
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-
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11,432
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Total
liabilities
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12,911,496
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9,812,976
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Equity
attributable to owners of the Company
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Share
capital
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233,633,493
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207,374,493
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Warrants
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5,176,397
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5,176,397
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Contributed
surplus
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14,771,907
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14,768,221
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Share-based payment
reserve
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5,892,305
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2,866,292
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Accumulated other
comprehensive income
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(281,814)
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24,028
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Deficit
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(222,454,699)
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(171,115,171)
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Total
equity
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36,737,589
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59,094,260
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Total liabilities
and equity
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49,649,085
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68,907,236
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CONSOLIDATED
STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
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For the years
ended June 30, 2015 and 2014
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In Canadian
Dollars
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2015
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2014
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Expenses
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Research and
development
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49,209,703
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17,367,385
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Selling, general and
administrative expenses
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5,514,272
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4,726,574
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Change in fair value
of contingent consideration payable
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65,787
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(2,911,218)
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Settlement of
pre-existing relationship
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-
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3,096,186
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Operating
loss
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(54,789,762)
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(22,278,927)
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Interest
income
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196,073
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220,119
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Foreign exchange
gain
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3,331,026
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284,523
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Loss on disposal of
property and equipment
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(76,865)
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(7,970)
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Net loss for the
year
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(51,339,528)
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(21,782,255)
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Other
comprehensive income (loss) for the year
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Items that may be
subsequently reclassified to net income:
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Cumulative
translation adjustment
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(305,842)
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24,028
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Comprehensive loss for the
year
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(51,645,370)
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(21,758,227)
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Basic and diluted
net loss per common share
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(1.41)
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(0.72)
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Notice to Readers: Information contained in our press releases
should be considered accurate only as of the date of this release
and may be superseded by more recent information we have disclosed
in later press releases, filings with the OSC, SEC or otherwise.
Except for historical information, this press release may contain
forward-looking statements, relating to expectations, plans or
prospects for Transition, including conducting clinical trials.
These statements are based upon the current expectations and
beliefs of Transition's management and are subject to certain risks
and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements.
These risks and uncertainties include factors beyond Transition's
control and the risk factors and other cautionary statements
discussed in Transition's quarterly and annual filings with the
Canadian commissions and the U.S. Securities and Exchange
Commission.
SOURCE Transition Therapeutics Inc.