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Ambit Bioscience Corporation (AMBI)

Q1 2014 Earnings Conference Call

May 6, 2014 05:00 p.m. ET


Marcy Graham – Executive Director, IR

Mike Martino – President and CEO

Alan Fuhrman – CFO

Bob Armstrong – VP, Preclinical Biology

Athena Countouriotis – CMO


Jonathan Eckard – Citi

Howard Liang – Leerink Partners

Nick Abbott – BMO Capital Markets



Welcome to the First Quarter 2014 Earnings Conference Call. My name is Bekiva, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Please note that this call is being recorded.

I would now turn the call over to Marcy Graham, Executive Director of Investor Relations. Marcy, you may begin.

Marcy Graham

Thank you. Good afternoon and welcome to the Ambit Bioscience's Conference Call to discuss financial and operating results for the first quarter of 2014. Joining me today on the call are Mike Martino, CEO; Alan Fuhrman, CFO; Bob Armstrong, our Vice President of Discovery and Pre-clinical development; and our Chief Medical Officer, Athena Countouriotis.

Before we proceed, I would like to remind everyone that statements made during this call regarding matters that are not historical facts, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, performance and achievements to differ materially from those expressed or implied by the statement.

To learn more about those risks and uncertainties, please read the risk factors set forth in our most recent filings with the SEC. All forward-looking statements made during this call speak only as of the time they are made. We are under no obligation to update these statements.

I will now turn the call over to Mike Martino, President and CEO of Ambit. Mike?

Mike Martino

Thank you, Marcy. Good afternoon everyone and welcome for our first quarter call for 2014. We last spoke just six weeks ago when we provided an update on the full year 2013. So today's scripted comments will be brief.

Our primary achievement in early 2014 was the initiation of our QUANTUM-R registration of Phase 3 Trial comparing Quizartinib as a monotherapy to chemotherapy regimens and relapse to refractory FLT3 ITD positive AML patients. We are also pleased with the acceptance of abstracts for presentation of ASCO and EHA both coming up in just a few weeks.

At ASCO, we'll present data and clinical benefit of Quizartinib as shown in the final results of a Phase 2B study in FLT3 ITD positive AML patients and on the benefit of treatment with Quizartinib and subsequent bridge to transplant for FLT3 ITD positive AML patients. The details of the abstracts to be presented in EHA will be available on their website in mid-May.

With the acceptance of these abstracts, Quizartinib will be then featured in more than 20 presentations at ASH, ASCO and EHA over the past two years and the date has been studied in more than 500 patients in company and investigator-sponsored trials. These studies to this point continue to show that Quizartinib rapidly reduces vulnerable (indiscernible). Reduce a significant percentage of patients to a potentially curative stem cell transplant is generally well tolerated and approves median and overall survival when compared to historical controls in both patients who undergo transplant and those who do not.

These clinical benefits when combined with a convenient once a day oral dose primarily administered an outpatient setting continue to support Quizartinib as the best in class with three inhibitor and clinical development, which continues to be reflected as well in a high level of investigator enthusiasm for the drug.

Based on data from both company and investigator sponsored studies as well as our preclinical data, we're enthusiastic about the potential for Quizartinib. On this point, we thought it would be helpful to have Bob Armstrong speak further on the biological properties that we believe position Quizartinib to move into additional settings including front line and combination and as a maintenance therapy.

Athena will follow with additional detail in our expanded clinical strategy beyond relapse and refractory AMS. Bob?

Bob Armstrong

Thank you, Mike, and hello everyone. As the first receptor (indiscernible) clinical development designed to specifically inhibit FLT3. Quizartinib has demonstrated unprecedented activity as monotherapy and relapse refractory AML. We believe Quizartinib's ability to achieve these responses is a result of its potency, selectivity and favourable pharmacokinetics allowing continuous once daily administration of the drug.

Quizartinib treatment in this context is able to effectively suppress the FLT3-ITD growth signal and rapidly reduce the (indiscernible) for many patients who have limited therapeutic options at this stage of the disease. In my of these patients, this blast reduction is sufficient to allow patients to be bridge to a hematopoietic stem cell transplant and a potential cure.

Recent studies on the genetics of AML, particularly those from Washington University had confirmed that AML is a genetically diverse disease with numerous mutations. The standard of care frontline chemotherapy ablates the bone marrow and non-discriminately reduces a leukemic burden independent of specific genetic mutations.

Following chemotherapy, however, a low level of minimal residual disease is often present and is comprised of chemotherapy resistant clones including those with the FLT3-ITD mutations. Those patients who relapse following chemotherapy who have the FLT3-ITD mutation do so more rapidly and with more aggressive disease in patients without it.

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