TRANSITION THERAPEUTICS INC TORONTO, Feb. 9, 2016 /PRNewswire/ - 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 -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 As at
December 31, 2015 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 Six month Six month Three month Three month
share data period ended period ended period ended period ended
December 31, December 31, December 31, December 31,
2015 2014 2015 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.
