TRANSITION THERAPEUTICS INC TORONTO, Feb. 9, 2015 /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, 2014. 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) 381-7839 (North America) and (212) 231-2900 (International). A replay of the conference call will be available on the Company's website (www.transitiontherapeutics.com) for seven days following the call.
Selected Highlights
Highlights for the Company during the six month period ended December 31, 2014 and up to the date of this press release include the following:
ELND005:
-- January 2015 - Transition's wholly owned subsidiary, Transition
Therapeutics Ireland Limited ("TTIL") revised the sample size of the
Phase 2 study (Harmony AD Study) from 400 AD subjects to 320 AD
subjects. After review of data from other recently released agitation
and aggression studies, the TTIL clinical development team re-evaluated
the sample size necessary for the Phase 2 study. The result of this
analysis is that a sample size of 300-320 patients will provide
sufficient statistical power to show treatment benefit of ELND005 over
placebo. Accordingly, TTIL has informed the FDA of the revised sample
size and enrolment is expected to be completed in February of 2015 with
release of study results expected mid calendar 2015;
-- November 24th, 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 United States Food and Drug
Administration ("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 Alzheimer's
disease ("AD") population;
-- November 20th, 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.
ELND005 is an oral small molecule compound being investigated as a treatment for agitation and aggression in AD and as a therapy for Down syndrome.
TT401 (LY2944876):
-- 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. In December, 2014, Lilly informed Transition
that 70% of the planned 375 study subjects had been enrolled in the
Phase 2 study of type 2 diabetic individuals.
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. Results from this study are expected in calendar Q4 2015.
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. Transition has no further funding obligations related to this clinical study.
Corporate Developments:
-- July 11, 2014 - Transition announced that Carl Damiani has been
appointed Chief Operating Officer of Transition.
Financial Liquidity
At December 31, 2014, the Company had cash resources of $26,756,324.
The Company's current cash projection indicates that the current cash resources should enable the Company to execute its core business plan and meet its projected cash requirements for the next 12 months.
Financial Review
For the three month period ended December 31, 2014, the Company recorded a net loss of $16,910,139 ($0.48 loss per common share) compared to a net loss of $1,253,772 ($0.04 loss per common share) for the three month period ended December 31, 2013.
For the six month period ended December 31, 2014, the Company recorded a net loss of $32,605,463 ($0.93 loss per common share) compared to a net loss of $3,584,958 ($0.12 loss per common share) for the six month period ended December 31, 2013.
Research and Development
Research and development expenses increased by $14,744,122 from $1,160,767 for the three month period ended December 31, 2013 to $15,904,889 for the three month period ended December 31, 2014. For the six month period ended December 31, 2014, research and development expenses increased $29,771,167 to $31,939,780 from $2,168,613 for the same period in fiscal 2014.
The increases in research and development expenses for both the three and six month periods ended December 31, 2014 are primarily due to increases in clinical development costs related to ELND005. The increases are also attributed to increases in development costs associated with diabetes drug candidate TT401 as the Company has paid Lilly an aggregate of US$14 million upon the achievement of all three patient enrollment milestones.
General and Administrative
General and administrative expenses increased by $229,730 from $973,719 for the three month period ended December 31, 2013 to $1,203,449 for the three month period ended December 31, 2014. For the six month period ended December 31, 2014, general and administrative expenses increased $588,202 to $2,509,281 from $1,921,079 for the same period in fiscal 2014.
The increases in general and administrative expenses for both the three and six month periods ended December 31, 2014 are primarily due to increases in professional fees, compensation costs as well as 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
(Unaudited)
In Canadian Dollars As at As at
December 31, 2014 June 30, 2014
--- ----------------- -------------
Assets
Current assets
Cash 26,756,324 57,212,004
Short term
investments - 3,059,562
Other receivables 1,387,856 220,514
Income tax and
investment tax
credits receivable 485,329 212,393
Prepaid expenses and
deposits 241,058 36,656
-------------------- ------- ------
28,870,567 60,741,129
Non-current assets
Property and
equipment 242,674 158,926
Intangible assets 7,704,613 8,007,181
----------------- --------- ---------
Total assets 36,817,854 68,907,236
============ ========== ==========
Liabilities
Current liabilities
Trade and other
payables 4,202,389 5,963,258
--------------- --------- ---------
4,202,389 5,963,258
Non-current
liabilities
Contingent
consideration
payable 4,569,179 3,838,286
Leasehold inducement 5,716 11,432
-------------------- ----- ------
Total liabilities 8,777,284 9,812,976
----------------- --------- ---------
Equity attributable
to owners of the
Company
Share capital 207,419,257 207,374,493
Warrants 5,176,397 5,176,397
Contributed surplus 14,768,221 14,768,221
Share-based payment
reserve 4,412,977 2,866,292
Accumulated other
comprehensive
income (15,648) 24,028
Deficit (203,720,634) (171,115,171)
------- ------------ ------------
Total equity 28,040,570 59,094,260
------------ ---------- ----------
Total liabilities
and equity 36,817,854 68,907,236
================= ========== ==========
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
For the six and three month periods ended December 31, 2014 and 2013
(Unaudited)
In Canadian Dollars, except per share data Six month Six month Three month Three month
period ended period ended period ended period ended
December 31, December 31, December 31, December 31,
2014 2013 2014 2013
--- ---- ---- ---- ----
Expenses
Research and development 31,939,780 2,168,613 15,904,889 1,160,767
Selling, general and 2,509,281 1,921,079 1,203,449 973,719
administrative expenses
-----------------------
Operating Loss (34,449,061) (4,089,692) (17,108,338) (2,134,486)
Change in fair value of contingent consideration payable (470,959) - (245,658) -
Interest income 112,247 102,868 46,554 56,731
Foreign exchange gain 2,202,310 401,866 397,303 823,983
--------------------- --------- ------- ------- -------
Net loss for the period (32,605,463) (3,584,958) (16,910,139) (1,253,772)
Other Comprehensive loss for the period
Items that may be
subsequently reclassified to
net income:
Cumulative translation adjustment (39,676) - (57,099) -
Comprehensive loss for the period (32,645,139) (3,584,958) (16,967,238) (1,253,772)
================================= =========== ========== =========== ==========
Basic and diluted net loss per common share (0.93) (0.12) (0.48) (0.04)
=========================================== ===== ===== ===== =====
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.
