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Sangamo Therapeutics, Inc. (SGMO)

Q3 2010 Earnings Call· Sun, Oct 31, 2010

$0.14

-32.29%

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Transcript

Elizabeth Wolffe

Management

Good afternoon and thank you for joining Sangamo’s management team on our conference call to discuss the company’s third quarter 2010 financial results. Also present during this call are several members of Sangamo’s senior management, including Edward Lanphier, President and Chief Executive Officer; Ward Wolff, Executive Vice President and Chief Financial Officer; Dale Ando, Vice President of Therapeutic Development and Chief Medical Officer; and Philip Gregory, Vice President of Research and Chief Scientific Officer. Following this introduction, Edward will highlight recent activities Ward will briefly review third quarter financial results for 2010. And Dale and Philip will update you on our ZFP-therapeutic program. Finally, Edward will summarize our current guidance and our goals for the rest of 2010. Following that we will open up the call for questions. As we begin, I’d like to remind everyone that the projections and forward-looking statements that we discuss during this conference call are based upon the information that we currently have available. This information will likely change over time. By discussing our current perception of the markets and the future performance of Sangamo with you today, we are not undertaking an obligation to provide updates in the future. Actual results may differ substantially from what we discuss today, and no one should assume at a later date that our comments from today are still valid. We alert you to be aware of risks that are detailed in such documents that the company files with the Securities and Exchange Commission, specifically our quarterly reports on Form 10-Q and our annual report on Form 10-K. These documents include important risk factors that could cause the actual results of the company’s operations to differ materially from those contained in our projections or forward-looking statements. Now, I’d like to turn the call over to Edward.

Edward Lanphier

President

Thank you, Liz. And thank you all for joining us for our conference call to discuss our third quarter results for 2010. Let me begin by briefly recapping a few of the events of the third quarter, which highlights our progress towards our goal of demonstrating the utility of our proprietary ZFP platform as a new class of therapeutics that function at the DNA level. We published groundbreaking pre-clinical data in the scientific journal Nature Biotechnology from our ZFN-Mediated Stem Cell Therapeutic Program for HIV/AIDS. This approach is based upon the use of our Zinc Finger Nuclease or ZFN technology to disrupt the CCR5 gene in human hematopoietic stem cells of HSCs. Disruption of the gene in HSCs enables us to make a permanent change which carries through all the cell types in the immune system. The publication of this data generated a great deal of interest in our HIV program and our technology in general and resulted in a number of articles including a feature in the Los Angeles Times, which was widely picked up by other news outlets. The generality of our ZFN CCR5 program forms the basis for a very promising therapeutic strategy which we are pursuing at a number of levels. The stem cell work published in Nature Biotechnology was carried out by Sangamo scientist and collaborators at the University of Southern California. You may recall that last September along with the third group from City of Hope, we were awarded a $14.5 million Disease Team Grant from the California Institute for a generative medicine or serum to bring this therapy to the clinic. This is an important program for us as methods that we establish for delivery of ZFNs and subsequent processing of modified cells will translate to other stem phase ZFP therapeutic products. Additionally,…

Ward Wolff

Management

Thank you, Edward, and good afternoon, everyone. As you know, after the close of the market today, we released our financial results for the third quarter ended September 30, 2010. And I am pleased to review the highlights of those results. Revenues in the third quarter of 2010 were $2.9 million compared to $4.1 million for the 2009 quarter. The third quarter 2010 revenues were primarily comprised of revenue from our collaboration agreements with Sigma-Aldrich and Dow AgroSciences, and agreements in protein production, as well as $700,000 of revenue from research grants. The decrease in revenues from $4 million to $2.2 million was primarily due to the completion of the research teams terms of our commercial license agreement with Sigma in July 2010 and to a decrease in amortized revenues associated with the commercial option fee paid by DAS in 2008. The increase in research grant revenues was primarily due to revenues in connection with Sangamo’s portion of the Disease Team Research Award from the California Institute for Regenerative Medicine and Research Funding for the Michael J. Fox Foundation for Parkinson’s research. Total operating expenses for the third quarter of 2010 were $11.7 million compared to $8.9 million for the same period in 2009. Research and development expenses were $8.8 million in the 2010 quarter and$6.2 million for the prior year quarter. The increase in R&D expenses was primarily related to our clinical trials of SB-509 in diabetic neuropathy and SB-728-T in HIV/AIDS. General and administrative expenses were $2.9 million in the third quarter of 2010 compared to $2.7 million in the 2009 quarter. For the third quarter of 2010, we reported a consolidated net loss of $8.7million or $0.19 per share compared to a net loss of $4.9 million or $0.12 per share for the third quarter of 2009.…

Edward Lanphier

President

Thanks, Ward. In addition to research grants and funding from the Juvenile Diabetes Research Foundation for our Phase 2B trial of SB-509 in diabetic neuropathy. Our partnerships with Sigma-Aldrich and Dow AgroSciences continue to provide non-dilutive revenues which partially offset our ongoing investment in our ZFP-therapeutic programs. As such we are able to carefully manage our cash burn and with $63.1million in cash at the end of the third quarter, and expected milestones in license fees in the fourth quarter, we are on track to meet our goal of ending 2010 with at least $60 million in cash and cash equivalents. Importantly, we have kept spending in hand while aggressive pushing towards our ultimate goal which is to establish our ZFP technology as a new platform for the creation of novel therapeutics that function at the DNA level. We are partners and more recently, their customers have provided clear demonstration of power and the generality of our technology. To achieve validation of our ZFP technology as a viable drug development platform, we are prosecuting clinical trials of both arms of our technology to generate clinical data that demonstrate the safety and efficacy of ZFP therapeutics. To that end, we have been working to advance programs in our gene regulation technology with SB-509 in multiple phase 2 trials and in ongoing phase 2B trial in diabetic neuropathy. More recently, we initiated phase 1 clinical trials in our ZFN-mediated gene editing technology for HIV and glioblastoma. As I mentioned earlier, I have asked Dale to update you on the progress of these ongoing clinical programs and particularly our HIV programs and our expectations for the release of clinical data from individual studies. Dale?

Dale Ando

President

Thank you, Edward. As most of you know, this is a very busy and exciting time in the clinical development of our ZFPs therapeutic pipeline. Over the next 12 months, we expect to have data from all of our ongoing clinical trials. Our zinc finger nuclease or ZFN gene medication technology is changing the face of biology by enabling modifications of genes and cells with unprecedented efficiency and specificity. Naturally enough, we are very excited to be evaluating this technology for the first time in man and are particularly pleased with the progress of our first trials which are part of a broader program to develop a therapeutic for the treatment of HIV/AIDS. There are actually two ongoing phase 1 trials of this therapeutic candidate. SB-728-T, one at the University of Pennsylvania in collaboration with Carl June and our own dose escalation trial here in California. Both use ZFNs to disrupt the CCR5 gene and the subjects own CD4 T cells. Although each clinical group is focused on a slightly different HIV patient population. CCR5 is a well validated target for HIV. This is a naturally occurring mutation in this gene. The CCR5-Delta 32, which occurs in about 1% of the population of the U.S. This mutation results in a non-functional CCR5 protein and makes these individuals, who are otherwise normal resistant to infection from the most common form of the virus. Further evidence demonstrating the importance of CCR5 in HIV infection was provided in an experiment carried out by doctors in Germany of the now famous Berlin patient, who was infected with HIV and also had leukemia. This individual received a bone marrow transplant from a donor who carried the CCR5-Delta 32 mutation, the patient was able to stop his antiretroviral therapy and three years later, the virus has…

Edward Lanphier

President

Thank you, Dale. We are very pleased to have to be able to give you an update on the significant and very encouraging process that we have made in our HIV clinical program. As Dale, described for you, we have completed accrual of Sangamo’s phase 1 trial in HIV, expanded this trial into a new group of subjects those failing HAART and initiated a new phase 1 2 trial in HIV infected individuals that are not on antiretroviral therapy. Both of these groups have a measurable viral load and allow us to expand our evaluation of this therapy to determine how these modified cells perform in the situation in which they may have a selective advantage over unmodified cells. In conclusion, our third quarter activities demonstrate our progress and continued focus and execution on our goal of establishing ZFP therapeutics as a new and highly differentiated class of human pharmaceuticals. We look forward to presenting data from our ALS program at the Society for Neuroscience meeting in November, and as Dale mentioned, we will use the 2011 CROI meeting in late February to present initial data from our HIV trials. We also look forward to updating you on our progress at the Lazard Capital Management 7th Annual Healthcare Conference on November 16th and 17th in New York. This completes our prepared comments. I would now like to open up the call for your questions.

Operator

Operator

Thank you. (Operator Instructions) And our first question comes from Liana Moussatos at Wedbush. Liana Moussatos – Wedbush: Thank you. Based on the initial data that you have seen so far with the HIV trials, which kinds of patients can you see being treated with this treatment?

Edward Lanphier

President

Thanks, Liana. This is Edward. I’ll give a comment and then maybe Dale would like to extend. I think we’re still early in this and I think that’s probably a great topic to discuss once both Carl June and perhaps our groups present at CROI. I think post the data and as we begin, we can really discuss the data. I think we’re going to be in a much better position to really then begin to give you a sense of where we think the optimal population for treatment is. I can think you can get a sense also from what we’re doing in terms of the expansion of the trial into HAART failure of patients as well as into these treatment-naïve populations. So, patients where we will be able to look at changes in viral load. I think that gives you a sense of at least, of the initial direction we’re going. Dale, you want to expand upon that?

Dale Ando

President

Yes. We’re basically segmenting the HIV population to three groups. One group pre-treatment with HAART, a measurable viral load and the second group on HAART therapy with either an un-measurable viral load and I think the studies that we’ve outlined that we’re initiating that we’ll get data the next year, we’ll help us better understand, which one of these three groups that we need to focus on with this product. Liana Moussatos – Wedbush: Thank you.

Edward Lanphier

President

Thanks, Liana.

Operator

Operator

Our next question comes from the line of Charles Duncan with JMP Securities. Charles Duncan – JMP Securities: Hi, guys. Thanks for the update. I guess I had a question, first of all, on the ZFN program that you outlined. Edward, I know you’re not going to tell us what data will – what the data are that you will be presenting, but could you perhaps give us some insights on, first of all, is this clinical proof of concept or is it really technological proof of concept? And what are the key things that you are tracking on to decide whether or not to continue to develop or to invest further in the program?

Edward Lanphier

President

Well, you’re right Charles. We won’t go into any specific data today. But let me try and address some of it. I think again I’m going to wait until the data are presented at CROI to really characterize like where we are in all of these. So, I’m not going to talk about clinical proof of concept. I do think there’s a good point around technical proof concept. Can we take our autologous T cells, can we modify them with zinc finger nucleases, can we characterize those cells, can we re-infuse them and as we said from the early data out of Carl’s work are those cells persistent. I think that’s a good indication of technical proof of concept. In terms of the kinds of things we’re looking at again, I’ll repeat the things that Dale said and then if you he wants to expand, I’ll certainly turn it over to him. But first and foremost, we’re looking at the safety of these modified cells. With that said, we’re going to then look at a variety of clinical parameters and I’ll repeat some of the things that Dale mentioned, we’ll evaluate the engraphment and persistence of these modified cells after they’re re-infuse. We’ll evaluate how they distribute in the body and particularly whether they traffic normally to lymph tissues such as in the gut. We’ll evaluate whether we see an overall change in the balance of the immune systems, specifically in terms of total CD4 count and the ratio of CD4 cells to CD8 cells in the body. So, I think those are going to be some of the important clinical parameters beyond the safety and tolerability and persistence of these cells that we will be reporting on in CROI. Dale?

Dale Ando

President

Yes, the only think you might talk about is just anything in terms of selective expansion. But I think that’s going to be more on the context of the some of the other patient populations.

Edward Lanphier

President

Yes, and Charles, I think that would be how we’d address those questions. Charles Duncan – JMP Securities: Okay. Dale, perhaps I could ask you if you could give us some insight on how you decided on the number of patients and the trial design for the next step.

Dale Ando

President

Well, I think with the set of size of 14 given the manufacturing requirements, I think is a practical size for obtaining that data in the next year. I think the – part of the child design in terms of choosing the types of patients was at the original design pre-clinically in in vitro work was the thought that B cells would be protected against HIV and that an active HIV infection would actually selectively expand these cells in a setting where there is a very prominent HIV infection. And I think moving to patients that have measurable viral load in their blood, I think is a very important sort of immunologic feature and was one of the primary scientific features that in which we develop the strategy in the first place. So, I think in terms of the design structure, the original intent and the human experiment would be CCR5 in Berlin patient or the protective patients, very strongly suggest that we should be able to take advantage of the selective expansion. Charles Duncan – JMP Securities: Okay. And final question for Ward. Ward, do you anticipate in 2011 to see any significant increase in your R&D expenditures?

Ward Wolff

Management

Well, Charles, we haven’t given guidance on 2011 yet, but we will do that at the year-end call. But I think that as a management team, I think we are going to be pretty focused on proceeding with the multiple programs with a fairly level cost structure intact. If anything, we might see a little bit of a fall-off based on the wind down or the initial costs with respect to the 901 DN trial. But, again, its early days, but directionally I think you can expect that it would be somewhat consistent. Charles Duncan – JMP Securities: Okay. Thanks for the added color, guys.

Edward Lanphier

President

Yes, thanks, Charles.

Operator

Operator

(Operator Instructions) And I’m showing no further questions in queue and I’d like to turn it over to our speakers for any closing remarks.

Edward Lanphier

President

Great. Thank you. We’d like to thank you for joining us and we look forward to speaking with you again when we release our fourth quarter and year-end financial information will be available later today, if you have any follow-up questions. One more thing – Go Giants.

Operator

Operator

Ladies and gentlemen, thank you for your participation in today’s conference. This concludes the program, you may all disconnect. Everyone have a great day.