TORONTO, Feb. 9, 2016 /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 three and six month periods
ended December 31, 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: (888) 227-6492
(North America) and (303) 223-2685
(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 six month period ended
December 31, 2015 and up to the date
of this press release include the following:
ELND005:
ELND005 is an oral small molecule drug candidate
with a proposed dual mechanism of action which includes β-amyloid
anti-aggregation and regulation of brain myo-inositol
levels. Transition's subsidiary Transition Therapeutics
Ireland ("TTIL") owns all ELND005 development and commercialization
rights.
- October 28, 2015 -
Transition announced that data from the Phase 2/3 clinical study of
ELND005 in Alzheimer's disease patients with moderate and severe
agitation and aggression was presented at the Clinical Trials in
Alzheimer's Disease (CTAD) meeting. A copy of the CTAD oral
presentation is available on the Company website at
www.transitiontherapeutics.com;
- October 15, 2015 -
Transition announced that its subsidiary, TTIL, has completed a
thorough review of the data related to the Phase 2/3 study of
ELND005 in AD patients with moderate or severe agitation and
aggression. The analysis identified a significant clinical
benefit of ELND005 in AD patients with severe agitation and
aggression, and will serve as the basis for patient selection in a
Phase 3 clinical study. The review was performed in consultation
with a group of key opinion leaders in the field of
neuropsychiatry.
TT401:
TT401 (LY2944876) is an oxyntomodulin analogue that has dual
agonist activity of the GLP-1 (Glucagon-Like Peptide-1) and
glucagon receptors.
- February 1, 2016 –
Transition announced the results of a Phase 2 clinical study of
drug candidate TT401 (LY2944876) for the treatment of type 2
diabetes. TT401 is a once-weekly administered
oxyntomodulin analog with dual GLP-1 and glucagon agonist activity.
TT401 development collaborator Eli Lilly and Company performed the
Phase 2 study enrolling 420 type 2 diabetes subjects into a 24 week
study consisting of a 12-week randomized blinded stage followed by
a 12-week open-label stage. The study included four once-weekly
dose arms of TT401 (10mg, 15mg, 30mg, 50mg), a placebo arm, and an
active comparator arm (exenatide extended release – 2mg). TT401
demonstrated HbA1c improvements of up to -1.43% (similar to the
exenatide arm). All TT401 dose arms and the exenatide arm were
statistically significant relative to the placebo arm at Weeks 12
and 24. TT401 also produced dose dependent weight loss (up to
-3.3 kg). The weight loss observed in the highest dose arm (50mg of
TT401) was statistically significant relative to both the placebo
and exenatide arms at weeks 12 and 24.
TT701 SARM:
TT701 is an oral drug candidate that is a selective androgen
receptor modulator (SARM). TTIL owns all TT701 development
and commercialization rights. TT701 is in Phase 2
clinical development as a therapy to ameliorate the symptoms
associated with androgen deficiency.
- October 29, 2015 –
Transition announced that its subsidiary, TTIL, has entered into
an agreement with Brigham
and Women's Hospital ("BWH") for an investigator-led clinical study
of drug candidate TT701. TTIL will support a Phase 2
study to evaluate selective androgen receptor modulator (SARM) drug
candidate TT701 as a therapy to improve the symptoms of androgen
deficiency in men with prostate cancer that have undergone a
radical prostatectomy procedure.
Financial Liquidity
At December 31, 2015, the Company
had cash resources of $29,070,189 and
a working capital of $26,870,703.
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 three month period ended December 31, 2015, the Company recorded a net
loss of $2,005,780 ($0.05 loss per common share) compared to a net
loss of $16,910,139 ($0.48 loss per common share) for the three month
period ended December 31, 2014.
For the six month period ended December
31, 2015, the Company recorded a net loss of $6,497,236 ($0.17
loss per common share) compared to a net loss of $32,605,463 ($0.93
loss per common share) for the six month period ended December 31, 2014.
Research and Development
Research and development expenses decreased by $14,241,943 from $15,904,889 for the three month period ended
December 31, 2014 to $1,662,946 for the three month period ended
December 31, 2015. For the six
month period ended December 31, 2015,
research and development expenses decreased $25,551,354 to $6,388,426 from $31,939,780 for the same period in fiscal
2015.
The decreases in research and development expenses for both the
three and six month periods ended December
31, 2015 are primarily due to a decrease in funding
obligations relating to TT401 as the Company paid a US$6 million milestone payment to Lilly during
the comparative three month period. The decrease in research
and development expenses is also due to a decrease in clinical
development costs related to ELND005 and reduced salary and related
expenses which resulted from cost cutting efforts.
General and Administrative
General and administrative expenses increased by $15,345 from $1,203,449 for the three month period ended
December 31, 2014 to $1,218,794 for the three month period ended
December 31, 2015. For the six
month period ended December 31, 2015,
general and administrative expenses increased $109,921 to $2,619,202 from $2,509,281 for the same period in fiscal
2015.
The increases in general and administrative expenses for both
the three and six month periods ended December 31, 2015 are primarily due to
inflationary increases in compensation costs which have been
partially offset by reduced professional fees.
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
(Unaudited)
In Canadian
Dollars
|
|
As
At
December 31,
2015
|
As at
June 30,
2015
|
|
|
|
|
Assets
|
|
|
|
Current
assets
|
|
|
|
Cash
|
|
29,070,189
|
40,510,758
|
Other
receivables
|
|
72,553
|
265,189
|
Income tax and
investment tax credits receivable
|
|
399,668
|
399,668
|
Prepaid expenses and
deposits
|
|
328,921
|
259,143
|
|
|
29,871,331
|
41,434,758
|
Non-current
assets
|
|
|
|
Property and
equipment
|
|
152,530
|
191,944
|
Intangible
assets
|
|
7,759,188
|
8,022,383
|
Total
assets
|
|
37,783,049
|
49,649,085
|
|
|
|
|
Liabilities
|
|
|
|
Current
liabilities
|
|
|
|
Trade and other
payables
|
|
2,064,780
|
8,549,895
|
Contingent
consideration payable
|
|
935,848
|
858,257
|
|
|
3,000,628
|
9,408,152
|
Non-current
liabilities
|
|
|
|
Contingent
consideration payable
|
|
3,980,476
|
3,503,344
|
Total
liabilities
|
|
6,981,104
|
12,911,496
|
|
|
|
|
Equity
attributable to owners of the Company
|
|
|
|
Share
capital
|
|
233,623,544
|
233,633,493
|
Warrants
|
|
3,150,558
|
5,176,397
|
Contributed
surplus
|
|
17,170,146
|
14,771,907
|
Share-based payment
reserve
|
|
6,472,380
|
5,892,305
|
Accumulated other
comprehensive income
|
|
(662,748)
|
(281,814)
|
Deficit
|
|
(228,951,935)
|
(222,454,699)
|
Total
equity
|
|
30,801,945
|
36,737,589
|
|
|
|
|
Total liabilities
and equity
|
|
37,783,049
|
49,649,085
|
|
|
|
|
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE
LOSS
For the six and three months ended December 31, 2015 and
2014
(Unaudited)
In Canadian
Dollars, except per
share data
|
|
Six month
period ended
December 31,
2015
|
|
Six month
period ended
December 31,
2014
|
Three month
period ended
December 31,
2015
|
|
Three month
period ended
December 31,
2014
|
|
|
|
|
|
|
|
|
Expenses
|
|
|
|
|
|
|
|
Research and
development
|
|
6,388,426
|
|
31,939,780
|
1,662,946
|
|
15,904,889
|
Selling, general and
administrative expenses
|
|
2,619,202
|
|
2,509,281
|
1,218,794
|
|
1,203,449
|
|
|
|
|
|
|
|
|
Operating
Loss
|
|
(9,007,628)
|
|
(34,449,061)
|
(2,881,740)
|
|
(17,108,338)
|
Change in fair value
of contingent consideration payable
|
|
(230,422)
|
|
(470,959)
|
(1,563)
|
|
(245,658)
|
Interest
income
|
|
63,719
|
|
112,247
|
26,255
|
|
46,554
|
Foreign exchange
gain
|
|
2,677,095
|
|
2,202,310
|
851,268
|
|
397,303
|
Net loss for the
period
|
|
(6,497,236)
|
|
(32,605,463)
|
(2,005,780)
|
|
(16,910,139)
|
|
|
|
|
|
|
|
|
Other
Comprehensive loss for the period
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Items that may be
subsequently reclassified to net income:
|
|
|
|
|
|
|
|
Cumulative
translation adjustment
|
|
(380,934)
|
|
(39,676)
|
(384,448)
|
|
(57,099)
|
Comprehensive loss
for the period
|
|
(6,878,170)
|
|
(32,645,139)
|
(2,390,228)
|
|
(16,967,238)
|
Basic and diluted
net loss per common share
|
|
(0.17)
|
|
(0.93)
|
(0.05)
|
|
(0.48)
|
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.