Navigation Links
Transition Therapeutics Announces Second Quarter Fiscal 2008 Financial Results
Date:2/12/2008

TORONTO, Feb. 12 /PRNewswire-FirstCall/ - Transition Therapeutics Inc. ("Transition" or the "Company") (TSX: TTH; NASDAQ: TTHI), a product-focused biopharmaceutical company developing therapeutics for disease indications with large markets including Alzheimer's Disease and Diabetes, today announced its financial results for the quarter ended December 31, 2007.

Selected Highlights

-------------------

During the second quarter of fiscal 2008 and up to the date of this press release, the Company achieved the following significant milestones:

ELND005 (AZD-103) - Alzheimer's Disease:

- On January 22, 2008, the Company received a US$5,000,000 milestone

payment from Elan. The milestone payment was triggered by the

initiation of a Phase II clinical study of Alzheimer's disease drug

candidate, ELND005 (AZD-103) on December 21, 2007;

- On December 21, 2007, Elan and Transition Dose First Patient in

Phase II Clinical Study of ELND005 (AZD-103) in Alzheimer's Disease.

The study is a randomized, double-blind, placebo-controlled, dose-

ranging, safety and efficacy study in approximately 340 patients with

mild to moderate Alzheimer's disease. Approximately 65 sites in North

America are expected to participate in the program. The study will

evaluate both cognitive and functional endpoints and each patient's

participation is planned to last approximately 18 months;

- On October 26, 2007, the Company Received the Remaining US$7,500,000

Upfront Payment from Elan. The receipt of US$7,500,000 represents the

second half of the US$15 million upfront payment under the Company's

global collaboration agreement with Elan.

TT-223 (formerly known as "G1") - Diabetes:

- On November 5, 2007, the Company Announced an Update on the Clinical

Development and Partnership activitieSix-month Six-month Three-month Three-month

period ended period ended period ended period ended

December 31, December 31, December 31, December 31,

2007 2006 2007 2006

$ $ $ $

-------------------------------------------------------------------------

REVENUES

Milestone revenue - 552,650 - -

Licensing fees 1,596,722 65,622 1,563,911 32,811

-------------------------------------------------------------------------

1,596,722 618,272 1,563,911 32,811

-------------------------------------------------------------------------

EXPENSES

Research and

development 5,245,922 3,769,702 2,480,123 1,680,714

General and

administrative 2,838,380 2,081,356 1,506,199 1,051,963

Amortization 1,323,224 5,434,033 663,906 2,465,726

Foreign exchange

loss (gain) (220,587) 8,483 (191,557) (3,577)

Loss on disposal of

capital assets and

assets held for sale - 41,614 - 27,515

-------------------------------------------------------------------------

9,186,939 11,335,188 4,458,671 5,222,341

-------------------------------------------------------------------------

Loss before the

following (7,590,217) (10,716,916) (2,894,760) (5,189,530)

Interest income,

net 1,289,031 404,664 692,552 331,423

Gain of company

transferred under

contractual

arrangement 650,000 400,000 650,000 -

-------------------------------------------------------------------------

Loss before

income taxes (5,651,186) (9,912,252) (1,552,208) (4,858,107)

Recovery of future

income taxes - 2,729,422 - -

-------------------------------------------------------------------------

Net loss and

comprehensive loss

for the period (5,651,186) (7,182,830) (1,552,208) (4,858,107)

-------------------------------------------------------------------------

Basic and diluted

net loss per

common share $(0.25) $(0.39) $(0.07) $(0.25)

-------------------------------------------------------------------------

-------------------------------------------------------------------------

CONSOLIDATED STATEMENT OF SHAREHOLDERS' EQUITY

For the six-month period ended December 31, 2007 and year ended June 30,

2007 (Unaudited in Canadian Dollars)

Number of Share Contributed

Shares Capital Surplus

-------------------------------------------------------------------------

# $ $

Balance, July 1, 2006 17,494,269 99,563,853 4,469,987

-------------------------------------------------------------------------

Adjustment to opening deficit

for change in accounting

policy related to research

inventory - - -

Stock options exercised 63,654 601,571 -

Stock options expired - - 17,765

Stock-based compensation expense - - -

Issued pursuant to private

placement, net 2,986,867 23,964,751 -

Issued on acquisition of

NeuroMedix Inc., net 685,951 9,858,143 -

Net loss for the year - - -

-------------------------------------------------------------------------

Balance, June 30, 2007 21,230,741 133,988,318 4,487,752

-------------------------------------------------------------------------

-------------------------------------------------------------------------

Issued pursuant to private

placement, net 1,736,107 23,968,567 -

Issued pursuant to ENI

Shareholder's Agreement 174,123 1,890,976 -

Stock options exercised 14,294 120,519 -

Stock-based compensation expense - - -

Net loss for the three-month

period ended December 31, 2007 - - -

-------------------------------------------------------------------------

Balance, December 31, 2007 23,155,265 159,968,380 4,487,752

-------------------------------------------------------------------------

-------------------------------------------------------------------------

Total

Stock Shareholders'

Options Defecit Equity

-------------------------------------------------------------------------

$ $ $

Balance, July 1, 2006 774,858 (69,504,180) 35,304,518

-------------------------------------------------------------------------

Adjustment to opening deficit

for change in accounting

policy related to research

inventory - (3,225,599) (3,225,599)

Stock options exercised (221,177) - 380,394

Stock options expired (17,765) - -

Stock-based compensation expense 1,002,480 - 1,002,480

Issued pursuant to private

placement, net - - 23,964,751

Issued on acquisition of

NeuroMedix Inc., net - - 9,858,143

Net loss for the year - (16,961,790) (16,961,790)

-------------------------------------------------------------------------

Balance, June 30, 2007 1,538,396 (89,691,569) 50,322,897

-------------------------------------------------------------------------

-------------------------------------------------------------------------

Issued pursuant to private

placement, net - - 23,968,567

Issued pursuant to ENI

Shareholder's Agreement - - 1,890,976

Stock options exercised (42,590) - 77,929

Stock-based compensation expense 684,170 - 684,170

Net loss for the three-month

period ended December 31, 2007 - (5,651,186) (5,651,186)

-------------------------------------------------------------------------

Balance, December 31, 2007 2,179,976 (95,342,755) 71,293,353

-------------------------------------------------------------------------

-------------------------------------------------------------------------

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.

s for its diabetes program.

Following negotiations, Novo Nordisk and Transition were not able to

come to agreement for an exclusive license to all of the Company's

diabetes programs. Accordingly, Transition terminated the agreement

between the companies, returning to Transition all rights held by

Novo Nordisk, relating to E1-I.N.T. Transition is continuing on-going

discussions with other interested parties to partner the diabetes

programs. In the interim, the Company is fully committed to support

and advance the clinical development of the diabetes programs,

leveraging its expertise in disease-modifying therapies for diabetes,

world-class scientific advisory board and solid financial position.

Corporate Developments:

- On January 7, 2008 the Company's common shares were approved for

listing and commenced trading on the NASDAQ Global Market. Prior to

this change, the Company's common shares were listed on the NASDAQ

Capital Market since August 20, 2007 under the symbol "TTHI". The

Company's common shares continue to trade on the Toronto Stock

Exchange in addition to the NASDAQ;

- On October 31, 2007 the Company received the third anniversary

payment of $650,000 from the sale of its subsidiary, Stem Cell

Therapeutics ("SCT"). Total payments received to date amount to

$1,850,000 with the final payment of $1,650,000 due in the first

quarter of fiscal 2009.

Pipeline Review

---------------

ELND005 (AZD-103) for Alzheimer's Disease

Transition's lead Alzheimer's disease compound ELND005 (AZD-103) is a disease modifying agent with the potential to both prevent and reduce disease progression, and improve symptoms such as cognitive function.

In September 2006, Transition announced a global collaboration with Elan to develop and commercialize ELND005 (AZD-103). In April 2007, Transition announced that the FDA granted Fast Track designation to the investigational drug candidate ELND005 (AZD-103).

On August 30, 2007, the Company announced the completion of Phase I clinical studies with ELND005 (AZD-103). Transition and its development partner Elan have performed multiple Phase I studies evaluating the safety, tolerability and pharmacokinetic profile of ELND005 (AZD-103) in healthy volunteers. Approximately 110 subjects have been exposed to ELND005 (AZD-103) in multiple Phase I studies, including single and multiple ascending dosing; pharmacokinetic evaluation of levels in the brain; and CSF and plasma studies. ELND005 (AZD-103) was safe and well-tolerated at all doses and dosing regimens examined. There were no severe or serious adverse events observed. ELND005 (AZD-103) was also shown to be orally bio-available, cross the blood-brain barrier and achieve levels in the human brain and CSF that were shown to be effective in animal models for Alzheimer's disease.

On December 21, 2007, Elan and Transition announced that the first patient had been dosed in a Phase II clinical study of ELND005 (AZD-103) in patients with Alzheimer's disease. The study is a randomized, double-blind, placebo-controlled, dose-ranging, safety and efficacy study in approximately 340 patients with mild to moderate Alzheimer's disease. Approximately 65 sites in North America are expected to participate in the program. The study will evaluate both cognitive and functional endpoints, and each patient's participation is planned to last approximately 18 months.

In connection with the initiation of the Phase II clinical study, the Company issued the former shareholders of ENI the first contingent consideration milestone in the form of 174,123 Transition common shares at a price of $10.86 per share. The shares issued had a fair value of $1,890,976 which represents additional consideration paid to acquire the technology, products and patents from ENI and accordingly, has been capitalized as intangible assets and will be amortized over the remaining useful life of the technology, products and patents.

TT-223 for Diabetes

Preclinical data in diabetes animal models demonstrate the efficacy of gastrin analogues alone, or in combination with GLP-1 analogues or epidermal growth factor analogues. In humans, Transition's recent Phase IIa clinical trial data showed that 4-weeks of E1-I.N.T. therapy (combination of gastrin analogue and epidermal growth factor analogue) in type 2 diabetes patients resulted in sustained reductions in blood glucose control parameters, including haemoglobinA1C, for 6 months post-treatment. Pre-clinical and clinical data suggests gastrin plays an important role in beta cell differentiation and function, capable of providing sustained glucose control in type 2 diabetes. Based on these data, Transition has commenced the studies to advance its lead gastrin analogue, TT-223, formerly known as "G1", into Phase II clinical trials in type 2 diabetes patients.

To support the Phase II clinical development program for TT-223, Transition is currently performing two Phase I studies to expand the dose ranges for TT-223. Transition expects to initiate the following Phase II clinical studies evaluating TT-223 in type 2 diabetes:

- A Phase II trial evaluating TT-223 in type 2 diabetes patients

receiving metformin with or without thiazolidinediones (TZDs) to

commence in the first half of calendar 2008;

- An additional Phase II study with TT-223 in type 2 patients receiving

either GLP-1 analogue therapy or insulin therapy is anticipated to

follow;

- The next steps in the development of TT-223 in combination with

Transition's epidermal growth factor analogue, will be evaluated

following the review of data from the above proposed Phase II trials.

Financial Review

----------------

Results of Operations

For the three-month period ended December 31, 2007, the Company recorded a net loss of $1,552,208 ($0.07 per common share) compared to a net loss of $4,858,107 ($0.25 per common share) for the three-month period ended December 31, 2006.

For the six-month period ended December 31, 2007, the Company recorded a net loss of $5,651,186 ($0.25 per common share) compared to a net loss of $7,182,830 ($0.39 per common share) for the six-month period ended December 31, 2006.

The decrease in net loss of $3,305,899 or 68% for the three-month period ended December 31, 2007 and $1,531,644 or 21% for the six-month period ended December 31, 2007 is largely due to decreased amortization expense resulting from the Waratah technology being fully amortized in the third quarter of fiscal 2007, recognition of the remaining unamortized upfront fee from Novo, increased interest income resulting from higher cash and held-to-maturity investment balances and the receipt of the second milestone payment from SCT. For the three-month period ended December 31, 2007, the decrease in net loss was partially offset by increases in research and development expense, and general and administrative expenses. For the six-month period ended December 31, 2007, the decrease in net loss was offset by the future income tax recovery of $2,729,422 that was recognized in the first quarter of fiscal 2007, and was also offset by increases in research and development and general expense and general and administrative expenses.

Revenues

Licensing fees increased to $1,563,911 for the three-month period ended December 31, 2007 from $32,811 for the three-month period ended December 31, 2006. For the six-month period ended December 31, 2007, licensing fees increased to $1,596,722 from $65,622 for the same period in fiscal 2007. These increases are due to the fact that the licensing agreement with Novo Nordisk was terminated during the three-month period ending December 31, 2007 and all remaining deferred amounts have been recognized as licensing fee revenue during the period.

Research and Development

Research and development expenses increased to $2,480,123 for the three-month period ended December 31, 2007 from $1,680,714 for the three-month period ended December 31, 2006. For the six-month period ended December 31, 2007, research and development expenses increased to $5,245,922 from $3,769,702 for the same period in fiscal 2007. These increases are primarily the result of an increase in clinical development costs related to ELND005 (AZD-103) and TT-223. The increase was also amplified in the three and six month periods ended December 31, 2007 as the comparative prior year period included the reimbursement by Novo Nordisk of E1-I.N.T.(TM) development costs in the amount of $201,000 and $703,293 for the three-month and six-month periods respectively resulting from the amended Novo Nordisk agreement. These increases were partially offset by decreases in clinical program expenses that related to the Company's completed I.E.T. clinical trials and a reduction of costs relating to the drug discovery platform.

General and Administrative

General and administrative expenses increased to $1,506,199 for the three-month period ended December 31, 2007 from $1,051,963 for the three-month period ended December 31, 2006. For the six-month period ended December 31, 2007, general and administrative expenses increased to $2,838,380 from $2,081,356 for the same period in fiscal 2007. These increases primarily resulted from increased professional fees, insurance and regulatory fees resulting from the NASDAQ listing, increased option expenses and increased corporate governance costs.

Amortization

Amortization for the three-month period ended December 31, 2007, was $663,906 as compared to $2,465,726 for the three-month period ended December 31, 2006. For the six-month period ended December 31, 2007, amortization was $1,323,224 as compared to $5,434,033 for the same period in fiscal 2007. These decreases primarily resulted from the Waratah technology being fully amortized during the third quarter of fiscal 2007. This decrease was partially offset by the full quarter impact of the amortization relating to the NeuroMedix technology acquired during the fourth quarter of fiscal 2007.

Recovery of Future Income taxes

Recovery of future income taxes remained unchanged from Nil for the three-month periods ended December 31, 2007 and 2006. For the six-month period ended December 31, 2007, recovery of future income taxes was Nil compared to $2,729,422 for the same period in fiscal 2007. The decrease in recovery of future income taxes is due to the recognition of future income tax assets resulting from the amalgamation of Ellipsis Neurotherapeutics Inc., 1255205 Ontario Inc., 1255206 Ontario Inc. and Waratah Pharmaceuticals Inc. which occurred during the three-month period ended September 30, 2006.

Interest Income, net

Interest income for the three-month period ended December 31, 2007, was $692,552 as compared to $331,423 for the same period in fiscal 2007. For the six-month period ended December 31, 2007, interest income was $1,289,031 as compared to $404,664 for the same period in fiscal 2007. These increases primarily resulted from increased cash balances due to the November 2006 and July 2007 private placements and the upfront payments received from Elan.

SCT Anniversary Payment

During the three month period ending December 31, 2007, the Company received the third anniversary payment of $650,000 in cash which has been recorded as a gain in the statement of loss and comprehensive loss. As of December 31, 2007, total payments received amount to $1,850,000. The final payment of $1,650,000 is due in the first quarter of fiscal 2009.

About Transition

----------------

Transition is a biopharmaceutical company, developing novel therapeutics for disease indications with large markets. Transition's lead products include ELND005 (AZD-103) for the treatment of Alzheimer's disease and TT-223 for the treatment of diabetes. Transition has an emerging pipeline of preclinical drug candidates acquired externally or developed internally using its proprietary drug discovery engine. Transition'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 http://www.transitiontherapeutics.com.

Financial Statements to Follow:

CONSOLIDATED BALANCE SHEETS

(Unaudited in Canadian Dollars)

December 31, June 30,

2007 2007

$ $

-------------------------------------------------------------------------

ASSETS

Current

Cash and cash equivalents 13,969,176 1,377,387

Held-to-maturity investments 45,607,212 33,414,383

Receivables 85,131 317,979

Investment tax credits receivable 638,369 559,405

Prepaid expenses and deposits 458,656 519,937

-------------------------------------------------------------------------

Total current assets 60,758,544 36,189,091

Capital assets, net 1,065,052 1,174,028

Intangible assets 27,230,501 26,632,609

-------------------------------------------------------------------------

89,054,097 63,995,728

-------------------------------------------------------------------------

-------------------------------------------------------------------------

LIABILITIES AND SHAREHOLDERS' EQUITY

Current

Accounts payable and accrued liabilities 1,242,303 2,866,655

Due to Elan Pharma International Limited 728,446 697,743

Current portion of deferred revenue - 131,244

-------------------------------------------------------------------------

Total current liabilities 1,970,749 3,695,642

Deferred revenue 15,704,255 9,885,733

Leasehold inducement 85,740 91,456

-------------------------------------------------------------------------

Total liabilities 17,760,744 13,672,831

-------------------------------------------------------------------------

Shareholders' equity

Share capital

Common shares 159,968,380 133,988,318

Contributed surplus 4,487,752 4,487,752

Stock options 2,179,976 1,538,396

Deficit (95,342,755) (89,691,569)

-------------------------------------------------------------------------

Total shareholders' equity 71,293,353 50,322,897

-------------------------------------------------------------------------

89,054,097 63,995,728

-------------------------------------------------------------------------

-------------------------------------------------------------------------

CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

(Unaudited in Canadian Dollars)


'/>"/>

SOURCE Transition Therapeutics Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Transition Therapeutics Announces Fiscal 2007 Year End Financial Results
2. Transition Therapeutics Receives Remaining Upfront Payment from Elan Corporation, plc
3. Transition Therapeutics to Hold Conference Call on First Quarter Fiscal 2008 Financial Results on Wednesday, November 14, at 8:30 A.M. EST
4. New UIC center to study end-of-life transition
5. Seabrook House Opens Transitional Living Facility: Seabrook West
6. Transition Therapeutics Announces Milestone Payment from Elan
7. Transition Therapeutics Announces Appointment of Vice-President of Business Development
8. Pure Weight Loss Takes Additional Steps To Assure Seamless Transition For Clients
9. Zimmer Spine Introduces New Rigid to Dynamic Stabilization Transition System
10. Bisexuality not a transitional phase among women, according to new research
11. Transition of Behavioral Health Services from WPIC-BV to Heritage Valley Health System
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from ... at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the Hynes Convention Center ... care topics including advance care planning, healthcare costs and patient and family engagement. ...
(Date:6/25/2016)... ... 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX users can easily ... of Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures ... . Simply select a ProHand generator and drag it above media or text in ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin ... injury. Recently, he has implemented orthobiologic procedures as a method for treating his ... of the first doctors to perform the treatment. Orthobiologics are substances that orthopaedic ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published ... unfamiliar with. The article goes on to state that individuals are now more comfortable ... less common operations such as calf and cheek reduction. The Los Angeles area medical ...
(Date:6/24/2016)... CA (PRWEB) , ... June 24, 2016 , ... Marcy was in a crisis. Her ... would lash out at his family verbally and physically. , “When something upset him, he ... he would use it. He would throw rocks at my other children and say he ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... Research and Markets has announced the addition of the ... to their offering. ... World Market for Companion Diagnostics covers the world market for ... report includes the following: , World IVD ... (N. America, EU, ROW), 2015-2020 , World IVD Companion ...
(Date:6/24/2016)... 2016  Arkis BioSciences, a leading innovator in ... durable cerebrospinal fluid treatments, today announced it has ... is led by Innova Memphis, followed by Angel ... investors.  Arkis, new financing will accelerate the commercialization ... release of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... 2016 Research and Markets has ... by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), ... Parenteral) - Global Forecast to 2021" report to ... The global pharmaceutical excipients market is projected to reach ... 6.1% in the forecast period 2016 to 2021. ...
Breaking Medicine Technology: