TPTX » Topics » Recent Developments

This excerpt taken from the TPTX 10-Q filed Nov 12, 2008.

Recent Developments

On November 6, 2008 we entered into an asset purchase agreement with Eisai Co., Ltd., or Eisai, pursuant to which Eisai agreed to purchase our Alzheimer’s disease genetics program assets in exchange for a one time cash payment of $1,500,000. Since 2002 our Alzheimer’s disease genetics program was a shared research effort between us and Eisai. Our cooperation agreement with Eisai related to the genetics program concluded on September 30, 2008. In connection with the conclusion of the agreement we reduced our work force by approximately 50 percent, primarily in the area of drug discovery. We currently have 13 employees supporting clinical, preclinical, business development, and administrative activities.

This excerpt taken from the TPTX 10-Q filed Aug 12, 2008.

Recent Developments

On August 6, 2008, Neil M. Kurtz, M.D. provided notice of his resignation as our President and Chief Executive Officer and as a member of our Board of Directors effective as of August 31, 2008. Dr. Kurtz resigned to assume the role of President and CEO of a major private healthcare provider.

On August 6, 2008, the Board appointed Evelyn Graham, 60, to the position of acting Chief Executive Officer, effective as of September 1, 2008. Ms. Graham has served as our Chief Operating Officer since October 2006. Ms. Graham joined TPTX, Inc., (“TPTX”), our wholly owned subsidiary, in 2004 as Vice President, Development. She was promoted to TPTX’s Vice President, Corporate Development in 2005 and Chief Operating Officer in 2006. Prior to joining the company Ms. Graham was Executive Director, Development Operations at Purdue Pharma, a privately-held pharmaceutical company, from 2000 to 2003. From 1998 to 2000, Ms. Graham was Senior Vice President of Business Development of Ingenix Pharmaceutical Services, a health information technology company and a division of UHG, and served as Vice President of Clinical Operations at Worldwide Clinical Trials, a contract research organization, prior to its acquisition by UHG. Previously, Ms. Graham held positions in operations management, healthcare utilization, and organizational planning at Bayer Corporation and Wyeth Pharmaceuticals (formerly Ayerst Laboratories). Ms. Graham holds a B.A. in biology from the University of Delaware and an M.B.A. from the University of Connecticut.

On June 11, 2008, TPTX entered into an agreement to borrow $3.6 million (the “Loan”) pursuant to a Loan and Security Agreement (the “Agreement”) with Comerica Bank (the “Bank”). The Loan is secured by a security interest in substantially all of our assets granted pursuant to a Third Party Security Agreement between us and the Bank. The collateral under the Third Party Security Agreement includes our rights to payment arising from the sale, license or other disposition of our intellectual property and to the underlying intellectual property only to the extent necessary to enforce the security interest in such payments. Pursuant to the terms of the Agreement, we also executed an Unconditional Guaranty of TPTX’s obligations under which we irrevocably guaranteed the prompt and complete payment of all amounts that TPTX owes to the Bank and performance by TPTX of the Agreement and any other agreements between TPTX and the Bank. The outstanding principal under the Loan will bear interest at a rate equal to 1.00% above the Bank’s prime rate and will mature on June 11, 2011. The Loan is to be repaid in 30 equal monthly installments of principal and interest, with interest-only payments payable during the period July through December 2008 and principal and interest payments beginning in January 2009.

In connection with the Agreement, we issued to Bank a warrant to purchase 78,832 shares of our common stock at a price per share of $1.37. The warrant is exercisable at any time prior to its expiration on June 11, 2013.

On June 12, 2008 we repaid the outstanding balance of $3.0 million under our Loan And Security Agreement dated September 27, 2005 with Oxford Finance Corporation and Silicon Valley Bank (the “Prior Agreement”). The Prior Agreement and all instruments and documents related thereto (excluding warrants issued in connection with the Prior Agreement) terminated on June 12, 2008, including without limitation, the termination of all security interests, liens and encumbrances, in connection with the Prior Agreement.

This excerpt taken from the TPTX 10-Q filed Nov 14, 2007.

Recent Developments

In October 2007, we announced that the 40 mg dose of tezampanel demonstrated statistically significant improvement on headache pain response, the primary endpoint, at two hours post-dose compared to placebo in a 306-patient, Phase IIb clinical trial for the treatment of a single, acute migraine attack. Two other doses of tezampanel, 70 mg and 100 mg, were evaluated and also demonstrated effects across a number of pain measurements although neither dose reached statistical significance on the primary endpoint. Although not powered to demonstrate statistical significance, improvement in key secondary measures at 40 mg were either statistically significant or trending when compared to placebo and corroborated the results for the primary endpoint of the study.  We intend to submit the data from this trial to the U. S. Food and Drug Administration, or FDA, in order to initiate a Phase III program in acute migraine in the second half of 2008.

In October 2007, we completed the evaluation of NGX426 through the 90 mg dose of our on-going Phase I maximum tolerated, single dose study.  We have not reached the maximum tolerated dose of NGX426 and therefore will need to submit an amendment to the FDA to modify the current protocol in order to continue dosing above 90 mg.

 

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In September 2007 we announced that Eisai elected to extend the term of the October 2005 Cooperation Agreement between us and Eisai for an additional twelve months pursuant to the terms of the agreement. Under the terms of the agreement and in connection with the extension, we received an upfront payment in October 2007 and will continue to receive research funding in support of the program for an additional year.

This excerpt taken from the TPTX 10-Q filed Nov 9, 2005.

(10) Recent Developments

 

As further described in Item 2 below under “The Phenserine Development Program,” the Company has determined not to commit further resources to the development of Phenserine.

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

This Form 10-Q contains “forward-looking” statements, as defined in the Private Securities Litigation Reform Act of 1995 that are based on current expectations, estimates and projections. Statements that are not historical facts, including statements about our beliefs and expectations, are forward-looking statements. These statements involve potential risks and uncertainties; therefore, actual results may differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they were made. We do not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Specifically, with respect to our drug candidates Phenserine, Posiphen™ and BisNorCymserine, Axonyx cannot assure that: any preclinical or clinical trials, whether ongoing or conducted in the future, will prove successful, and if successful, that the results could be replicated; safety and efficacy profiles of any of its drug candidates will be established, or if established, will remain the same, be better or worse in future clinical trials, if any; pre-clinical results related to cognition and the regulation of beta-APP will be sustained by ongoing or future clinical trials, if any, or that any of its drug candidates will be able to slow the progression of Alzheimer’s disease; any of its drug candidates will support an NDA filing, will be approved by the FDA, or if approved, will prove competitive in the market; Axonyx will be able to successfully out-license any of its drug candidates; Axonyx will be able to successfully in-license any additional compounds, or that Axonyx will obtain the necessary financing to support its drug development program.

We refer you to our report on form 10-K for the year ended December 31, 2004 filed with the SEC, where these risks and others are more fully described.

We do not undertake to discuss matters relating to our ongoing clinical trials or our regulatory strategies beyond those which have already been made public or discussed herein.

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