Transition Therapeutics Announces First Quarter Fiscal 2014 Financial Results
TORONTO, Nov. 12, 2013 /PRNewswire/ – Transition Therapeutics Inc. (“Transition” or the “Company”) (TSX: TTH; NASDAQ: TTHI), a
product-focused biopharmaceutical company developing therapeutics for
disease indications with large markets, today announced its financial
results for the three month period ended September 30, 2013.
During the three month period ended September 30, 2013 and up to the
date of this press release, the Company announced the following:
-- September 4, 2013 - Transition announced that their licensing partner Elan had dosed the first patient in a Phase 2a clinical study of ELND005 in Down Syndrome; -- July 17, 2013 - Transition announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to the development program for ELND005 which was submitted for the treatment of Neuropsychiatric Symptoms (NPS) in Alzheimer's disease (AD).The FDA concluded that the development program for ELND005 for the treatment of NPS in AD meets their criteria for Fast Track Designation. Transition's licensing partner, Elan is responsible for all development and commercialization activities and costs of ELND005;
-- July 23, 2013 - Transition announced the exclusive licensing of worldwide rights to a novel small molecule transcriptional regulator ("TT601") from Lilly for the treatment of osteoarthritis ("OA") pain.TT601 is a potent and selective ligand for a novel nuclear receptor target. Modulating the activity of this novel target in patients with osteoarthritis may provide pain relief to a large segment of OA patients who do not have adequate response to therapy with NSAIDs (non-steroidal anti-inflammatory drugs). TT601 has completed preclinical development to date and Transition anticipates can enter the clinic in the first half of calendar 2014;
-- August 15, 2013 - Transition announced the closing of the private placement involving Jack W. Schuler, Larry N. Feinberg, Oracle Investment Management, certain Transition Board members, management and other existing shareholders of US$11 million by purchasing 2,625,300 units of the Company at a price of US$4.19 per unit.
The Company’s cash, cash equivalents and short term investments were
$37,253,647 at September 30, 2013.
In light of the recent private placement, the Company’s cash projections
indicate that the current cash resources should enable the Company to
execute its core business plan and meet its projected cash requirements
well beyond the next 12 months.
For the three month period ended September 30, 2013, the Company
recorded a net loss of $2,331,186 ($0.08 loss per common share)
compared to net income of $7,736,046 ($0.29 income per common share)
for the three month period ended September 30, 2012.
Revenue is nil in the three month period ended September 30, 2013
compared to $10,815,200 (US$11,000,000) in the three month period ended
September 30, 2012. In August 2012, Elan dosed the first patient in a
Phase 2 clinical study of ELND005 in Bipolar Disorder, triggering the
next milestone payment of US$11million under the amended agreement with
Elan. The milestone payment was recognized as revenue during the
three-month comparative period ending September 30, 2012.
Research and development expenses decreased to $1,007,846 for the three
month period ended September 30, 2013 from $2,054,546 for the three
month period ended September 30, 2012. The decrease in research and
development expenses is primarily due to decreases in clinical
development costs related to diabetes drug candidate TT401 which has
been partially offset by an increase in clinical development costs
related to TT601.
General and administrative expenses increased to $947,360 for the three
month period ended September 30, 2013 from $816,902 for the three month
period ended September 30, 2012. The increase in general and
administrative expenses is primarily due to increased business and
corporate development activities.
Transition is a product-focused biopharmaceutical company, developing
novel therapeutics for disease indications with large markets. The
Company’s lead CNS drug candidate is ELND005 for the treatment of
Alzheimer’s disease, Bipolar Disorder and Down syndrome. Transition’s
lead metabolic drug candidate is TT401 for the treatment of type 2
diabetes and accompanying obesity. Transition has also in-licensed a
lead drug candidate from Lilly in the area of osteoarthritis pain
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
As at As at In Canadian Dollars September 30, 2013 June 30, 2013 Assets Current assets Cash and cash equivalents 32,173,444 23,067,937 Short term investments 5,080,203 5,057,702 Other receivables 44,881 35,792 Investment tax credits receivable 223,524 180,652 Prepaid expenses and deposits 240,607 359,164 37,762,659 28,701,247 Non-current assets Property and equipment 161,917 168,034 Intangible assets 8,678,604 8,938,674 Total assets 46,603,180 37,807,955 Liabilities Current liabilities Trade and other payables 595,866 874,149 Current portion of contingent 2,321,373 2,321,373 consideration payable 2,917,239 3,195,522 Non-current liabilities Contingent consideration payable 1,434,958 1,434,958 Leasehold inducement 20,005 22,863 4,372,202 4,653,343 Equity attributable to owners of the Company Share capital 174,494,446 165,367,524 Warrants 2,025,839 - Contributed surplus 14,768,002 14,768,002 Share-based payment reserve 2,606,793 2,352,002 Deficit (151,664,102) (149,332,916) 42,230,978 33,154,612 Total liabilities and equity 46,603,180 37,807,955
CONSOLIDATED STATEMENTS OF INCOME (LOSS) AND
COMPREHENSIVE INCOME (LOSS)
For the three months ended September 30, 2013 and 2012
In Canadian Dollars, except per share September 30, September 30, data 2013 2012 Revenues Licensing fees - 10,815,200 Expenses Research and development 1,007,846 2,054,546 Selling, general and administrative expenses 947,360 816,902 Operating Income (loss) (1,955,206) 7,943,752 Interest income 46,137 33,617 Foreign exchange gain (loss) (422,117) (241,323) Net income (loss) and comprehensive income (loss) for the period (2,331,186) 7,736,046 Basic and diluted net income (loss) per common share (0.08) 0.29
Notice to Readers: Information contained in our press releases should be
considered accurate only as of the date of the 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.
SOURCE Transition Therapeutics Inc.