EXEL » Topics » Q2 2008 Highlights

This excerpt taken from the EXEL 8-K filed Aug 5, 2008.

Q2 2008 Highlights



Announced that the development term of the company’s six-year discovery and development collaboration with GSK will successfully conclude on October 27, 2008, as scheduled. GSK previously selected XL880 and will be able to choose one additional compound until November 2008 from among XL184, XL281, XL228, XL820, and XL844. Exelixis will have the right to develop and commercialize compounds not selected by GSK, either alone or in collaboration with partners.



Presented seven abstracts at the American Society of Clinical Oncology (ASCO) annual meeting. These included reports on three clinical trials of XL647 (three abstracts), two clinical trials of XL880 (GSK089) (two abstracts), and one clinical trial each of XL184 (one abstract) and XL765 (one abstract).



Reported preliminary phase 1 data from an ongoing trial of XL228 in patients with chronic myelogenous leukemia (CML) or Philadelphia chromosome-positive acute lymphocytic leukemia (Ph+ALL) who are resistant to, or intolerant of, the approved BCR-ABL inhibitors imatinib and dasatinib. The data were presented in a poster session at the 13th Congress of the European Hematology Association.



Entered into an agreement with Deerfield Management, a leading healthcare investment organization and significant Exelixis stockholder, to provide Exelixis with up to $150.0 million in financing through a flexible financing facility. The funds can be drawn at any time through December 4, 2009. Exelixis is under no obligation to draw on the facility and can terminate the facility agreement without penalty at any time. Funds drawn will be repayable five years after signing of the facility agreement and can be repaid in shares of Exelixis common stock, subject to certain restrictions, or cash at any time during the term of the agreement.

This excerpt taken from the EXEL 8-K filed Feb 21, 2006.

2005 Highlights


    We initiated five Phase 1 clinical trials: XL880, XL820, XL844, XL184 in patients with solid tumors who did not respond to previous therapy and for XL784 in healthy volunteers


    We presented Phase 1 clinical data for XL999 and XL647 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in November


    We completed a Phase 1 clinical trial for XL999 and initiated Phase 2 clinical trials in patients with non-small cell lung, colorectal, ovarian and renal cell cancers


    We completed the repeat-dose Phase 1 clinical trial for XL784 in healthy volunteers


    We held our first annual Exelixis R&D Day in December


    We amended our GSK agreement to focus the collaboration on 12 programs in clinical and pre-clinical development and received $35.0 million in milestones under the amended collaboration


    We completed a clinical development financing transaction with Symphony Capital for up to $80.0 million to fund the initial Phase 2 clinical development of XL647, XL999 and XL784


    We completed four major transactions: Helsinn Healthcare SA (XL119), Genentech (Notch), Bristol Myers Squibb (LXR) and Wyeth (FXR)


    We completed an equity offering for net proceeds of approximately $49.6 million in August

“In 2005, we made tremendous strides in our effort to make cancer therapies with the potential to have a positive impact on patients’ lives. We have eight compounds in ongoing clinical trials and we anticipate sharing additional clinical data this year at several medical meetings” said George A. Scangos, Ph.D., president and chief executive officer of Exelixis.

“In 2006, we will continue to focus our efforts on moving compounds rapidly into and through the clinic, while efficiently managing our financial resources,” continued Dr. Scangos.

This excerpt taken from the EXEL 8-K filed Nov 3, 2005.

Third Quarter 2005 Highlights


Development: We continued to make significant advances in our clinical programs. We initiated three phase 1 clinical trials and now have a total of eight compounds in clinical development, as well as three compounds in preclinical development. We are pleased with the progress of the trials and the enrollment rates. All of the compounds are of high quality and each is directed to a different spectrum of targets. Importantly, the third quarter marks our entry into a new phase where we will be able to begin to discuss our clinical data publicly. Abstracts from our three lead internally-developed cancer compounds were accepted for presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics meeting in Philadelphia, and we are excited about the opportunity to discuss these data. Highlights for the quarter include the following:


    Phase 1: XL820, XL844, XL184 – We initiated phase 1 clinical trials for each of these compounds. XL820 and XL184 are being studied in patients with refractory solid tumors for whom there are no available therapies known to prolong survival. XL844 is being studied in patients with chronic lymphocytic leukemia


    XL784: A repeat-dose phase 1 clinical trial of a capsule formulation of XL784 was initiated in healthy volunteers to assess safety, pharmacokinetics and pharmacodynamics


    Phase 2: We announced plans for broad phase 2 programs for our three most advanced internally generated development compounds - XL999, XL647 and XL784


    Clinical Data: Abstracts describing phase 1 data for XL647, XL999 and XL880 were accepted for poster presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, which will be held in Philadelphia, PA November 14-18


Financing: In August, we raised net proceeds of $49.6 million through the issuance of 6.5 million shares of common stock pursuant to a shelf registration statement to support our ongoing research and development activities.


For additional details on our compounds please visit our website at www.exelixis.com under the heading “Pipeline.”


“2005 is an unprecedented year for Exelixis. Our ability to advance 8 compounds through clinical development, including one compound in phase 3 testing and three compounds that will soon move to phase 2 is a strong validation of our entire process from target identification through clinical development, and reflects our continued ability to execute,” said George A. Scangos, Ph.D. president and chief executive officer of Exelixis. “The first four orally

administered compounds to enter the clinic all exhibit good oral bioavailability and appropriate half-lives. I am excited about the quality and number of compounds in the pipeline, and I believe that the reasons for our enthusiasm will become evident as we are able to share the data, as we will begin to do at the upcoming AACR-NCI-EORTC meeting. Our solid financial position is a reflection of the cash that we have brought in from a variety of sources this year, and enables us to aggressively move our pipeline forward. I believe that we are crossing an inflection point and that 2005 marks the beginning of a new, clinically-focused era for Exelixis.”


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