Dr. Tony Cruz reports
TRANSITION THERAPEUTICS ANNOUNCES FISCAL 2012 YEAR END FINANCIAL RESULTS
Transition Therapeutics Inc. has released its financial
results for the year ended June 30, 2012.
During fiscal 2012 and up to the date of this press release, the company
achieved the following significant milestones.
On Aug. 30, 2012, Transition announced that its licensing partner
Elan had dosed the first patient in a phase 2 clinical study of ELND005 in bipolar disorder. The study is a placebo-controlled safety and efficacy study of oral
ELND005 as an adjunctive maintenance treatment in patients with bipolar
1 disorder to delay the time to occurrence of mood episodes. As the
first patient has been dosed in the study, Transition will receive a
milestone payment of $11-million (U.S.) from Elan.
On May 14, 2012, Transition announced that a mini-symposium entitled,
"The Emerging Clinical Profile of Oral Scyllo-inositol (ELND005) in
Alzheimer's Disease: A Dual Mechanism of Action," was presented at the 12th International Stockholm/Springfield Symposium on Advances in Alzheimer
On April 26, 2012, Transition announced that three ELND005 poster
presentations were presented at the American Academy of Neurology. These presentations described responder analyses and characteristics,
along with findings on the effect of ELND005 on the emergence of
On Sept. 27, 2011, Transition announced that phase II clinical study
data of ELND005 (AZD-103) in mild to moderate Alzheimer's disease has
been published in the peer-reviewed journal, Neurology. The Neurology article is entitled, "A Phase II randomized trial of
ELND005, scyllo-inositol, in mild-moderate Alzheimer's disease."
On July 15, 2011, Transition announced that ELND005 (AZD-103) phase II
clinical trial data would be presented at the International Conference
of Alzheimer's Disease (ICAD) meeting on July 18, 2011.
On June 18, 2012, Transition announced the results of the phase I
clinical study of Type 2 diabetes drug candidate, TT-401. The phase 1, double-blind, placebo-controlled randomized study enrolled
48 non-diabetic obese subjects in six cohorts evaluating six escalating
subcutaneous single doses of TT-401. TT-401 demonstrated an acceptable
safety and tolerability profile in non-diabetic obese subjects in the
study. TT-401 exhibited the expected pharmacological effect on glucose
and pharmacodynamic biomarkers at doses that were safe and tolerable.
The pharmacokinetic profile, assessed over 28 days, demonstrated a
half-life consistent with once-weekly dosing.
On Dec. 12, 2011, Transition announced that the first patient has
been dosed in a phase I clinical study of Type 2 diabetes drug
candidate, TT-401. TT-401 is a once-weekly administered peptide being studied for its
potential to lower blood glucose levels in patients with Type 2
diabetes and accompanying obesity.
On Nov. 22, 2011, Transition Therapeutics announced a $5-million
(U.S.) private placement. Under the non-brokered private placement, Transition issued 3,703,703
common shares at a price of $1.35 (U.S.) for gross proceeds of approximately
The company's cash and cash equivalents, and short-term investments were
$19,012,345 at June 30, 2012.
Under the terms of the amended agreement with Elan, dosing of the first
patient in another clinical trial of ELND005 (AZD-103) triggers the
payment of an $11-million (U.S.) milestone. The company expects to receive
the $11-million (U.S.) milestone payment during the first quarter of fiscal
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 well beyond the next 12
During the year ended June 30, 2012, the company recorded a net loss of
$12,269,845 (48-cent loss per common share) compared with a net loss of
$5,689,613 (25-cent loss per common share) for the year ended June 30,
In fiscal 2011, the company and Elan mutually agreed to modify their
collaboration agreement for the development and commercialization of
ELND005 (AZD-103). Under the terms of the modification, Transition is
no longer obligated to finance the development or commercialization of
ELND005 (AZD-103). The recognized net revenue of $8,951,400 ($9-million (U.S.)) in fiscal 2011 represented the agreement modification payment
that was received partially in lieu of the contractually required phase
III milestone payments.
Revenue is nil in the year ended June 30, 2012, compared with $10,251,394
in the year ended June 30, 2011. The decrease in revenue is due to the
receipt of the $9-million (U.S.) agreement modification payment received
from Elan in fiscal 2011.
Research and development expenses decreased $295,250 or 3 per cent from
$8,493,975 for the fiscal year ended June 30, 2011, to $8,198,725 for
the fiscal year ended June 30, 2012. The decreases are primarily due to
decreased clinical development costs related to ELND005 (AZD-103) and
TT-301/302, decreased amortization due to the fact that the technology
and patents acquired from Protana were fully amortized during the
second quarter of fiscal 2011, and decreased salaries and related costs
associated with head count reductions. The decrease is largely offset by
an increase in preclinical and clinical development costs associated
with advancing the TT-401/402 compounds.
General and administrative expenses decreased by $801,037 or 15 per cent from
$5,208,317 for the fiscal year ended June 30, 2011, to $4,407,280 for
the year ended June 30, 2012. The decrease in general and
administrative expenses during the fiscal year ended June 30, 2012, is
largely due to decreases in payroll resulting from head count reductions
as well as decreases in consulting, insurance expense and facility
lease costs. The decrease in general and administrative expenses is
partially offset by increased professional fees as well as increased
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
For the years ended June 30,
Licensing fees - $ 10,251,394
Direct costs of services - 1,299,994
Gross profit - 8,951,400
Research and development $ 8,198,725 8,493,975
Selling, general and administrative expenses 4,407,280 5,208,317
Loss on disposal of property and equipment 125,748 116,312
Operating (loss) (12,731,753) (4,867,204)
Interest income 165,070 201,085
Interest expense (851) (530)
Foreign exchange gain (loss) 297,689 (348,133)
Change in fair value of contingent consideration payable - (674,831)
Net (loss) and comprehensive (loss) for the year (12,269,845) (5,689,613)
Basic and diluted net (loss) per common share (0.48) (0.25)
We seek Safe Harbor.
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