ARQL

ArQule, Inc. (ARQL)

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ArQule Inc. (ARQL)

Q1 2010 Earnings Conference Call

May 6, 2010 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

Mark Monane – Needham

Joel Sendek – Lazard Capital

Bret Holley – Oppenheimer

Howard Liang – Leerink Swann

George Zavoico – MLV

Presentation

Operator

Good day, ladies and gentlemen, and welcome to the Q1 2010 ArQule Inc. earnings conference call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. If anyone should require assistance during the conference, please press star then zero on your touchtone telephone. As a reminder, this conference is being recorded.

I would like to introduce your host for today’s conference Mr. Bill Boni, Vice President of Investor Relations. Mr. Boni, you may begin.

Bill Boni

Good morning everyone. Welcome to the ArQule investor conference call reviewing operational and financial results for the first quarter of fiscal year 2010. This is Bill Boni at ArQule. This morning, we issued a press release that reported results for the fiscal quarter ended March 31, 2010. This release is available on our website at www.arqule.com.

Leading the call today will be Paolo Pucci, Chief Executive Officer of ArQule. 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; Dr. Thomas Chan, Chief Scientific Officer and Rob Weiskopf, Vice President of Finance.

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 and good morning everyone and thank you for joining us this morning. I would like to begin by recapping the second-generation program for our lead compound ARQ 197 first-in-class C-Met inhibitor.

The second generating program we have designed and began to implement over the last two years is intended to explore broadly the efficacy of ARQ 197 as a monotherapy specifically C-Met associated soft tissue sarcoma in germ cell tumors and in hepatoma second line therapy.

Also, it’s intended to explore the utility of ARQ 197 in combination in the following tumors: non-small cell lung cancer, colon cancer, gemcitabine-sensitive and sorafenib-sensitive tumors.

Out of all these trials – second generation trials that are ongoing, three are particularly relevant because they are designed as double-blind randomized. The non-small cell lung trial is designed as such, the HCC second line as designed as such and the colon cancer second line 3 (blood) combination is designed as such.

We have very recently reported results from the first of these three phase II double blind randomized trial. The trial that saw the combination of ARQ 197 plus erlotinib compared to erlotinib alone.

Let me give you briefly some summary details of what we have announced and I (inaudible) to say that the study demonstrated that ARQ 197 plus erlotinib yielded a 66% improvement in progression free survival in patients with advanced refractory non-small cell lung cancer.

In the total population of the trial the intent to treat population, that is, which was 167 patients, the median PFS was 16.1 weeks for the ARQ 197 plus erlotinib arm compared with 9.7 weeks in the erlotinib plus placebo arm.

In our interaction with opinion leaders since we announced the data, we have understood that this difference is considered to be meaningful. We have also understood that it was important to demonstrate that the placebo arm performs consistently with historic norms because it makes any comparison to that historic norm for the treatment arm more meaningful.

The difference in PFS between the two arms in the intent to treat population did not reach statistical significance (inaudible) that difference is measured applying a log-rank statistical test. However, when adjusting for imbalances, and we have reported before that imbalances of core relative to two group of patients EGFR (inaudible).

When adjusting for those imbalances in the distribution of the key prognostic practice the difference in PFS between the treatment and placebo arm was statistically significant when measured by applying a Cox regression analysis and such a Cox regression analysis had been pre-specified in our statistical plan for secondary efficacy analysis.

This is for the intent to treat population. Once we look at the largest – all the subgroups that we can examine, we see that improvement in PFS was even more pronounced in the predefined subgroup, or patients with non-squamous histology. This was a large group in number, 117 patients of the 167 total patients enrolled.

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