Allos Therapeutics, Inc. (ALTH)
Q2 2010 Earnings Call
July 28, 2010 8:30 am ET
Monique Greer – VP, Corporate Communications & IR
Paul Berns – President & CEO
Charles Morris – Chief Medical Officer
Jim Caruso – EVP and Chief Commercial Officer
Bruce Goldsmith – VP of Corporate Development
David Clark – VP of Finance and Treasurer
Lucy Lu – Citigroup
Charles Duncan – JMP Securities
Mark Monane – Needham & Company
Brian Skorney – Thinkequity
Jason Kantor – RBC Capital Markets
Chris Naragordi with JP Morgan
Josh Schimmer – Leerink Swann & Company
Previous Statements by ALTH
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Good morning, Ladies and Gentlemen. Thank you for standing by. Welcome to the Allos Therapeutics Second Quarter 2010 Financial Results Conference call. (Operators Instructions)
I would know like to turn the conference over to Monique Greer, Vice President of Investor Relations. Please go ahead.
Good morning, everyone. We thank you for joining us on this conference call to review our second quarter 2010 financial results and other corporate updates, including the top-line results from our randomized Phase2b clinical study of FOLOTYN in advanced non-small cell lung cancer.
Following formal remarks by management, the conference will be open for questions.
With me here today are Paul Berns, President and Chief Executive Officer; Jim Caruso, Chief Commercial Officer; David Clark, Vice President of Finance; Dr. Charley Morris, Chief Medical Officer; and Bruce Goldsmith, Vice President of Corporate Development.
This morning we issued two press releases and filed the company’s quarter report on Form 10Q for the quarter ended June 30, 2010.
In addition to reporting our second quarter financial results, we issued a press release announcing top-line results on our randomized Phase2b clinical study of FOLOTYN in advanced small-cell lung cancer.
Copies of both releases can be found in the Investor’s section of our website at Allos.com.
Before we begin, please note that during the course of the call, we will make forward-looking statements concerning our company that are not historically facts.
Those forward-looking statements will not guarantee the future performance and are subject to risk and uncertainties that may cause actual results to different materially from those anticipated by the forward-looking statements.
Additional information concerning these risks and uncertainties is contained in the risk-factor section of our quarter report on Form 10Q for the quarter ended June 30, 2010. And in the company’s other periodic reports and filings with the Securities and Exchange Commission.
The company cautions investors necessarily [inaudible] on these forward looking statements. All forward-looking statements are based on information currently available to the company on the [inaudible] and the company undertakes no obligation to advise or update these forward-looking statements to reflect events or circumstances after the date hereof except as required by law.
I will now turn the call over to Paul Berns, who will begin his discussion with the overview of our business. After Paul’s remarks, the management team will review clinical, commercial and financial highlights before we open the call for questions. Paul?
Thank you, Monique. And good morning everyone. First half of this year was a busy period for Allos, highlighted by the U.S. commercial launch of FOLOTYN for patients with relapsed or refractory peripheral T-cell lymphoma.
Aggressive peripheral T-cell lymphomas have been a largely ignored group of hematologic diseases. And FOLOTYN is the first and only drug approved by the FDA for the treatment of relapsed or refractory PTCL.
We are in the early stage of our commercial experience as a company, and continue to make important progress.
We enter the second half of the year with the drive and determination we believe are required to continue building the marketplace awareness for both PTCL and FOLOTYN to capitalize on what we believe to be a significant commercial opportunity.
Jim will provide an update of our U.S. Commercial activities, and David will provide an update on our financial results for the second quarter, later in the call.
One of our key objectives for this year is to advance our strategic lifecycle plan for FOLOTYN in both hematological malignancies and solid tumors.
As Monique mentioned, this morning we announced top-line results from our randomized-Phase 2b study of FOLOTYN in patients with advanced non-small cell lung cancer.
We are pleased that the results of this trial demonstrated the clinical activity of FOLOTYN in these patients.
Charley will review the top-line results in greater detail and provide additional insights in a few moments.
I want to take a moment to recognize and thank all of the patients who enrolled in the trial, our valued clinical investigators who helped up generate these data in a very short timeframe, and patient families and caregivers who play a vital roll in the clinical trial process.
Moving forward, we plan to continue driving our strategic lifecycle development plan for FOLOTYN with the goal of extending FOLOTYN’s commercial opportunity and building additional value for our company’s potential expanded indication in both the U.S. and abroad.
With that, I will turn the call over to Charley to review the top-line results from our Phase2b non-small cell lung cancer study, and to provide an update on our other ongoing clinical development programs.
And following Charley’s comments, Jim will provide an update on our commercial activities.
Thank you, Paul. I would like to express my appreciation to the patients and their families which made this study possible. So now I’ve took two months to summarize a design followed by the results.
Two-hundred and one current or former smokers were randomized one to one and with multi-center international Phase 2b study comparing FOLOTYN to erlotinib in patients we’ve previously treated to Stage III/B4 non-small cell lung cancer. Participating patients have been receiving one of two prior systemic treatments including at least one prior platinum regimen.
The outcome of the study we randomized between the starting dose of FOLOTYN at 230 milligrams per meters squared every two weeks, then erlotinib at 150 milligrams daily. Up to 35 patients are being recruited to study/ The starting FOLOTYN dose which is used in 190 milligram per meters squared in the further 166 patients enrolled in the trial.