TORONTO, May 11, 2016 /PRNewswire/ - Transition
Therapeutics Inc. ("Transition" or the "Company") (TSX: TTH;
NASDAQ: TTHI), a biopharmaceutical development company advancing
novel therapeutics for CNS, metabolic disease and androgen
deficiency indications, today announced its financial results for
the three and nine month periods ended March
31, 2016. 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) 698-9012 (North
America) and (303) 223-4374 (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 nine month period ended
March 31, 2016 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 is an oxyntomodulin analogue that has dual agonist
activity of the GLP-1 (Glucagon-Like Peptide-1) and glucagon
receptors.
- April 18, 2016 – Transition
announced that Lilly will not elect to advance diabetes drug
candidate, TT401 into Phase 3 development. Under the
companies' collaboration agreement, all TT401 development and
commercialization rights will be transferred to Transition.
Transition is unencumbered to advance TT401 on its own or with a
third party;
- 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 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 4 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.
- April 25, 2016 – Transition
announced the dosing of the first patient of a Phase 2 study of
selective androgen receptor modulator (SARM) drug candidate
TT701. Brigham and Women's
Hospital (BWH) is conducting the investigator-led Phase 2 clinical
study which is expected to enroll up to 125 subjects at selected
specialized clinical sites including BWH. The principal
investigator for the Phase 2 study is Dr. Shalender Bhasin, Director of the Research
Program in Men's Health: Aging and Metabolism at BWH and an
internationally recognized endocrinologist with expertise in
testosterone biology and men's aging;
- October 29, 2015 –
Transition announced that its subsidiary, TTIL, has entered into
an agreement with BWH for an investigator-led clinical study
of drug candidate TT701. TTIL will support a Phase 2 study
to evaluate 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 March 31, 2016, the Company had
cash resources of $24,768,772 and a
working capital of $23,095,324.
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 March
31, 2016, the Company recorded a net loss of $4,177,942 ($0.11
loss per common share) compared to a net loss of $4,748,096 ($0.13
loss per common share) for the three month period ended
March 31, 2015.
For the nine month period ended March 31,
2016, the Company recorded a net loss of $10,675,178 ($0.28
loss per common share) compared to a net loss of $37,353,559 ($1.04
loss per common share) for the nine month period ended March 31, 2015.
Research and Development
Research and development expenses decreased by $3,309,363 from $4,888,272 for the three month period ended
March 31, 2015 to $1,578,909 for the three month period ended
March 31, 2016. For the nine
month period ended March 31, 2016,
research and development expenses decreased $28,860,717 to $7,967,335 from $36,828,052 for the same period in fiscal
2015.
The decreases in research and development expenses for both the
three and nine month periods ended March 31,
2016 are primarily due to a decrease in clinical development
costs related to ELND005 and reduced salary and related expenses
which resulted from cost cutting efforts. The decrease in research
and development expenses for the nine month period ended
March 31, 2016 is also due to a
decrease in funding obligations relating to TT401 as the Company
paid US$14 million in milestone
payments to Lilly during the comparative nine month period.
General and Administrative
General and administrative expenses decreased by $69,073 from $1,268,531 for the three month period ended
March 31, 2015 to $1,199,458 for the three month period ended
March 31, 2016. For the nine
month period ended March 31, 2016,
general and administrative expenses increased $40,848 to $3,818,660 from $3,777,812 for the same period in fiscal
2015.
The decrease in general and administrative expenses for the
three month period ended March 31,
2016 are primarily due to reduced professional fees which
have been partially offset by inflationary increases in
compensation costs.
The increase in general and administrative expenses for the nine
month period ended March 31, 2016 are
primarily due to business taxes paid for the Company's US
subsidiary and 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, metabolic disease and androgen
deficiency 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 as well as drug candidate TT701, a selective androgen
receptor molecule. 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
March 31,
2016
|
|
As at
June 30,
2015
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
Cash
|
|
|
24,768,772
|
|
40,510,758
|
Other
receivables
|
|
|
53,348
|
|
265,189
|
Income tax and
investment tax credits receivable
|
|
|
424,355
|
|
399,668
|
Prepaid expenses and
deposits
|
|
|
157,126
|
|
259,143
|
|
|
|
25,403,601
|
|
41,434,758
|
Non-current
assets
|
|
|
|
|
|
Property and
equipment
|
|
|
133,351
|
|
191,944
|
Intangible
assets
|
|
|
7,554,259
|
|
8,022,383
|
Total
assets
|
|
|
33,091,211
|
|
49,649,085
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
Trade and other
payables
|
|
|
1,406,388
|
|
8,549,895
|
Contingent
consideration payable
|
|
|
901,889
|
|
858,257
|
|
|
|
2,308,277
|
|
9,408,152
|
Non-current
liabilities
|
|
|
|
|
|
Contingent
consideration payable
|
|
|
3,804,036
|
|
3,503,344
|
Total
liabilities
|
|
|
6,112,313
|
|
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
|
|
|
17,458,649
|
|
14,771,907
|
Share-based payment
reserve
|
|
|
6,519,525
|
|
5,892,305
|
Accumulated other
comprehensive income
|
|
|
(643,501)
|
|
(281,814)
|
Deficit
|
|
|
(233,129,877)
|
|
(222,454,699)
|
Total
equity
|
|
|
26,978,898
|
|
36,737,589
|
|
|
|
|
|
|
Total liabilities
and equity
|
|
|
33,091,211
|
|
49,649,085
|
|
|
|
|
|
|
CONSOLIDATED
STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
|
For the nine and
three months periods ended March 31, 2016 and 2015
|
(Unaudited)
|
|
|
|
|
|
|
In Canadian
Dollars, except per share data
|
|
Nine month
period ended
March 31, 2016
|
Nine month
period ended
March 31, 2015
|
Three month
period ended
March 31, 2016
|
Three month
period ended
March 31, 2015
|
|
|
|
|
|
|
Expenses
|
|
|
|
|
|
Research and
development
|
|
7,967,335
|
36,828,052
|
1,578,909
|
4,888,272
|
Selling, general and
administrative expenses
|
|
3,818,660
|
3,777,812
|
1,199,458
|
1,268,531
|
|
|
|
|
|
|
Operating
Loss
|
|
(11,785,995)
|
(40,605,864)
|
(2,778,367)
|
(6,156,803)
|
Change in fair value
of contingent
|
|
|
|
|
|
consideration
payable
|
|
(232,427)
|
(747,698)
|
(2,005)
|
(276,739)
|
Interest
income
|
|
97,923
|
146,551
|
34,204
|
34,304
|
Foreign exchange gain
(loss)
|
|
1,247,393
|
3,930,317
|
(1,429,702)
|
1,728,007
|
Loss on disposal of
property and equipment
|
|
(2,072)
|
(76,865)
|
(2,072)
|
(76,865)
|
Net loss for the
period
|
|
(10,675,178)
|
(37,353,559)
|
(4,177,942)
|
(4,748,096)
|
|
|
|
|
|
|
Other
Comprehensive loss for the period
|
|
|
|
|
|
|
|
|
|
|
|
Items that may be
subsequently
|
|
|
|
|
|
reclassified to
net income:
|
|
|
|
|
|
Cumulative
translation adjustment
|
|
(361,687)
|
35,596
|
19,247
|
75,272
|
Comprehensive loss
for the period
|
|
(11,036,865)
|
(37,317,963)
|
(4,158,695)
|
(4,672,824)
|
Basic and diluted
net loss per common share
|
|
(0.28)
|
(1.04)
|
(0.11)
|
(0.13)
|
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.