Arrowhead Research Corporation (ARWR)
F4Q2010 Earnings Call Transcript
December 22, 2010 4:30 pm ET
Brandi Floberg – IR
Christopher Anzalone – President and CEO
Ken Myszkowski – CFO
David Block – CCA Capital
Donald Hutchinson – Safe Harbor Financial Management
Brian Benio [ph]
Mark Arique [ph]
Bill Boutin – Equanum Capital Management
Previous Statements by ARWR
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Greetings and welcome to the Arrowhead Research Corporation fiscal 2010 year-end conference call. At this time, all participants are on a listen-only mode. A brief question-and-answer session will follow the formal presentation. (Operator instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Ms. Brandi Floberg, Investor Relations counsel. Thank you, Ms. Floberg. You may begin.
Thank you, operator. Good afternoon, everyone, and thank you for joining us today to discuss Arrowhead's results for its fiscal 2010 year-end and fourth quarter ended September 30, 2010. With us today from management are President and CEO, Dr. Christopher Anzalone, and Chief Financial Officer, Ken Myszkowski. Management will provide a brief overview of the quarter and will then open the call up to your questions. Also on the call for participation in the Q&A session is Dr. Thomas Schluep from Calando and Dr. Mark Tilley from Unidym.
Before we begin, I would like to remind you that comments made during today's call may contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements other than statements of historical fact, including without limitation those with respect to Arrowhead’s goals, plans, and strategies, are forward-looking statements. Without limiting the generality of the foregoing words such as may, will, expect, believe, anticipate, intend, could, estimate, or continue, or the negative or other variations thereof or comparable terminology are intended to identify forward-looking statements.
In addition, any statements that refer to projections of Arrowhead’s future financial performance, trends in its businesses, or other characterizations of future events or circumstances are forward-looking statements. Forward-looking statements represent managements’ current expectations and are inherently uncertain.
You should also refer to the discussions under Risk Factors in Arrowhead’s Annual Report on Form 10-K for additional matters to be considered in this regard. Thus actual results may differ materially. Arrowhead undertakes no duty to update any of the forward-looking statements discussed on today’s call.
With that said, I’d like to turn the call over to Dr. Christopher Anzalone, President and CEO of the company. Chris?
Thanks, Brandi. Good afternoon, everyone, and thank you for joining us on our call today. Fiscal 2010 was a pivotal year for our company from both scientific and corporate standpoints. We are a much different company now than when I spoke with you a year ago, and we have achieved a number of important strategic and operational goals designed to accelerate our broader objectives of assembling a leading portfolio of nanomedicine companies.
So what has changed? First and foremost, we reported first ever clinical data proving systemic delivery of siRNA in humans and gene silencing via RNAi. As we have discussed in the past, these breakthrough data are important to both the RNA industry and to our company. Positive gene silencing data are of no value, however, unless coupled with a well-tolerated therapeutic.
We reported positive interim safety data from Calando’s Phase 1 clinical trial at the 2010 American Society of Clinical Oncology Meeting or ASCO. We have expanded the breadth of our nanomedicine portfolio by creating a new subsidiary, Ablaris Therapeutics, to address the large obesity markets opportunity and secure an outside capital for its initial funding by increasing our ownership position in our subsidiaries and by initiating partnerships and operations with our earlier stage opportunities.
We have established new partnerships for Unidym. We have decreased Arrowhead’s capital requirements for Unidym by bringing in non-dilutive outside capital into the subsidiary. We have expanded our leadership with key additions to our Board, and we have improved our balance sheet, reduced our costs, and streamlined our operations.
That said, at the end of September, we introduced an aggressive list of goals for the remainder of the calendar year. We knew when we introduced this roadmap that our rapid and diligent action would be critical to meeting our objectives. We had 13 goals to accomplish in only three months. We have accomplished a vast majority of these goals, and I’m proud of their achievements. However, there were two key accomplishments that we have not yet achieved. So I’d like to start with those.
It was our goal to complete enrolling patients in Calando’s Phase 1 clinical trial and to complete its first partnership, and we are still working on these. I actually believe that the circumstances surrounding the need to extend our time horizon on these goals may ultimately be a positive for our mid and long-term value proposition. Allow me to explain.
Calando’s Phase 1 trial has been running for over two years now at two different sites. It is a dose escalation trial whose primary objectives are to determine the safety profile and to assume parameters of Calando’s lead candidate, CALAA-01. As you know, interim data were published at the 2010 ASCO Meeting and in the Scientific Journal of Nature reporting the early safety profile and positive delivery results respectively.
We have reached dose levels where we can see targeted RNA and protein [ph] silencing via RNAi, but have still not determined the maximum tolerated dose, or MTD. While we are hoping to complete enrolling patients by the end of 2010, I think the fact that we are still recruiting patients is a positive sign. Our delivery system RONDEL has been very well tolerated, and we are still trying to determine what the MTD is.