TRANSITION THERAPEUTICS INC TORONTO, Sept. 15, 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 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
In Canadian
Dollars June 30, 2015 June 30, 2014
----------- ------------- -------------
Assets
Current assets
Cash 40,510,758 57,212,004
Short term
investments - 3,059,562
Other
receivables 265,189 220,514
Income tax and
investment
tax credits
receivable 399,668 212,393
Prepaid
expenses and
deposits 259,143 36,656
------------- ------- ------
41,434,758 60,741,129
Non-current
assets
Property and
equipment 191,944 158,926
Intangible
assets 8,022,383 8,007,181
---------- --------- ---------
Total assets 49,649,085 68,907,236
============ ========== ==========
Liabilities
Current
liabilities
Trade and
other
payables 8,549,895 5,963,258
Contingent
consideration
payable 858,257 -
-------------- ------- ---
9,408,152 5,963,258
Non-current
liabilities
Contingent
consideration
payable 3,503,344 3,838,286
Leasehold
inducement - 11,432
----------- --- ------
Total
liabilities 12,911,496 9,812,976
------------ ---------- ---------
Equity
attributable
to owners of
the Company
Share capital 233,633,493 207,374,493
Warrants 5,176,397 5,176,397
Contributed
surplus 14,771,907 14,768,221
Share-based
payment
reserve 5,892,305 2,866,292
Accumulated
other
comprehensive
income (281,814) 24,028
Deficit (222,454,699) (171,115,171)
------- ------------ ------------
Total equity 36,737,589 59,094,260
------------ ---------- ----------
Total
liabilities
and equity 49,649,085 68,907,236
============ ========== ==========
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
For the years ended June 30, 2015 and 2014
In Canadian Dollars 2015 2014
------------------- ---- ----
Expenses
Research and development 49,209,703 17,367,385
Selling, general and administrative expenses 5,514,272 4,726,574
Change in fair value of contingent
consideration payable 65,787 (2,911,218)
Settlement of pre-existing relationship - 3,096,186
Operating loss (54,789,762) (22,278,927)
Interest income 196,073 220,119
Foreign exchange gain 3,331,026 284,523
Loss on disposal of property and equipment (76,865) (7,970)
------------------------------------------ ------- ------
Net loss for the year (51,339,528) (21,782,255)
Other comprehensive income (loss) for the year
Items that may be subsequently reclassified to
net income:
Cumulative translation adjustment (305,842) 24,028
--------------------------------- -------- ------
Comprehensive loss for the year (51,645,370) (21,758,227)
------------------------------- ----------- -----------
Basic and diluted net loss per common share (1.41) (0.72)
=========================================== ===== =====
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.
