ARQL

ArQule, Inc. (ARQL)

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ArQule, Inc. (ARQL)

Q3 2009 Earnings Call Transcript

November 5, 2009 9:00 am ET

Executives

Bill Boni – VP, IR/Corporate Communications

Paolo Pucci – CEO

Rob Weiskopf – VP of Finance, Corporate Controller & Treasurer

Brian Schwartz – Chief Medical Officer

Thomas Chan – Chief Scientific Officer

Analysts

Jay [ph] – Oppenheimer

Joel Sendek – Lazard Capital Markets

Mark Monane – Needham & Company

Howard Liang – Leerink Swann

George Zavoico – Westport Capital Markets

Presentation

Operator

Good day, ladies and gentlemen, and welcome to the third quarter 2009 ArQule Incorporated earnings investor conference call. My name is Keesha and I will be your operator for today. At this time, all participants are in listen-only mode. We will conduct a question-and-answer session towards the end of this conference. (Operator instructions) As a reminder this conference is being recorded for replay purposes.

I would now like to turn the call over to Mr. Bill Boni, Vice President, Investor Relations. Please proceed, sir.

Bill Boni

Thank you, Keesha. Good morning, everyone. Welcome to the ArQule investor conference call reviewing operational and financial results for the third quarter of fiscal year 2009. This morning, we issued a press release that reported results for the fiscal quarter ended September 30, 2009. This release is available on our website at www.arqule.com.

Leading the call today will be Paolo Pucci, Chief Executive Officer of ArQule, who will be followed by Rob Weiskopf, Vice President of Finance. Also present for the company and available for questions at the end of the formal portion of the call are Peter Lawrence, President and Chief Operating Officer; Dr. Brian Schwartz, Chief Medical Officer; and Dr. Thomas Chan, Chief Scientific Officer.

Before we begin, please note that we will be making forward-looking statements as defined in the Private Securities Litigation Act of 1995. Actual results may differ materially from those projected in the forward-looking statements due to numerous risks and uncertainties that exist in ArQule's operations, development efforts, and the business environment, including those factors discussed in our press release announcing this call and posted on our website, as well as in our reports on forms 10-Q and 10-K and subsequent documents filed with the SEC.

The forward-looking statements contained in this call represent the judgment of ArQule as of today. ArQule disclaims any intent or obligation to update any forward-looking statement except to the extent required by law. We will provide an opportunity for questions and answers at the end of this call.

I would now like to introduce the CEO of ArQule, Paolo Pucci.

Paolo Pucci

Thank you, Bill. Good morning, everybody, and thank you for joining us this morning. We are closing to the end of the year. And I think it is appropriate for me to start by recapping how we are doing here at ArQule against the objectives we have set for ourselves for this year. First of all, we are on track to meet or to exceed the recruitment goals for the ARQ 197 development program.

Second, we are continuing to develop our pipeline candidates, including those from our Eg5 program and our B-RAF program. Work on goals of those programs is proceeding as planned. And we are also accelerating our discovery network, and as proof of that, we will present soon here in Boston, the triple meeting, our novel FGFR program.

Based on the successful implementation of our business plan for 2009, we can look ahead to 2010 and we can say that in 2010 -- precisely, during the first half of 2010, we will have two very important events for our company. The first event or set of events is around 197 c-Met program. We will avail data from the non-small cell lung cancer trial and from our MiT program. You will see that the non-small cell lung trial has been executed in record time. It is a testament to the work that has been done here at ArQule, but as well it is a demonstration of the interest that the scientific community had in such a trial.

I would say that arguably that is the most important event coming up for ArQule in the first half of next year. The results were another event that we are going to have early next year in the first half and that is the end of Phase I for ARQ 621, which is the lead compound from our Eg5 program.

Let me now provide you some detail for the ARQ 197, our first in class c-Met program. First of all, I’ll go back to the non-small cell lung cancer trial. Last month, we announced that patient enrollment in this trial has been completed with approximately 170 patients enrolled in the US, in Western Europe and in Eastern Europe. I would like to remind you that the trial design is randomized double-blind design comparing the combination of ARQ 197 and erlotinib against placebo and erlotinib in EGFR inhibitor-naïve patients in second line therapy.

In addition, this trial provides for (inaudible) that allows us to treat in third line therapy patients who have progressed after receiving FGFR therapy in the form of erlotinib in earlier line of therapy. The primary endpoint for this trial is progression-free survival, and final data is expected, as I mentioned, to be available in the first half of 2010. So again I would like to say, a very robust trial with a very strong design, with a very strong clinical rationale that has steered up a very significant interest, in our opinion, from the investigators. They rewarded our effort by recruiting basically very rapidly for this trial.

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