Sangamo BioSciences CEO Discusses Q3 2011 Results - Earnings Call Transcript

| About: Sangamo BioSciences, (SGMO)

Sangamo BioSciences, Inc. (NASDAQ:SGMO)

Q3 2011 Earnings Call

October 25, 2011 5:00 pm ET

Executives

Dr. Elizabeth Wolffe – Senior Director, Corporate Communications

Edward O. Lanphier II – President and Chief Executive Officer

H. Ward Wolff – Chief Financial Officer, Principal Financial and Accounting Officer, Executive Vice President

Geoffrey M. Nichol – Executive Vice President, Research and Development

Analysts

Charles Duncan – JMP Securities

Ted Tenthoff – Piper Jaffray

Liana Moussatos – Wedbush Securities

Operator

Good day, ladies and gentlemen and welcome to the Sangamo BioSciences Quarterly Teleconference. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions and how to participate will be given at that time. (Operator Instructions) And as reminder, today’s conference call is being recorded.

Now, I would like to turn the conference over to your host, Dr. Elizabeth Wolffe.

Dr. Elizabeth Wolffe

Thank you, Matthew. Good afternoon and thank you for joining Sangamo’s management team on our conference call to discuss the company's third quarter 2011 financial results. Joining me on the call are Edward Lanphier, President and Chief Executive Officer; Ward Wolff, Executive Vice President and Chief Financial Officer; and Geoff Nichol, Executive Vice President, Research and Development.

Following this introduction, Edward will highlight recent activities, Ward will briefly review third quarter financial results for 2011 and finally, Edward and Geoff will summarize the status of our ongoing ZFP Therapeutic programs and our goals for the remainder of 2011. Following that, we will open up the call for questions.

As we begin, I'd like to remind people 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 market 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 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 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 O. Lanphier II

Thank you, Liz. And thank you all for joining us for our conference call to discuss our third quarter results for 2011. As we have had a busy few months probably I begin by briefly recapping recent events.

In early October, we announced that our double-blind placebo controlled Phase 2b clinical trial SB-509-901 did not meet study endpoints in subjects with moderate severity diabetic neuropathy.

We are obviously disappointed that the trial did not produce a better outcome in the pre-specified primary and secondary endpoints. Therefore, as we discussed earlier this month and based upon these results, we have discontinued further clinical development of SB-509 and will focus our attention and resources on our rich pipeline, ZFP Therapeutic programs particularly in HIV/AIDS and in monogenic diseases. In that regard, exciting new data from our Phase 1 studies of SB-728-T and novel therapeutic approach to HIV/AIDS represented in two presentations at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy or ICAAC in mid-September.

These data have important implications for the future development of our HIV program and later in this call, Geoff will provide a brief summary of our findings and outline our plans for two new studies of SB-728-T.

We’ll also continue to validate the capability and breadth of applications of our ZFP technology with publications of preclinical data in high impact journals.

In mid-October, we published a preclinical study in Nature demonstrating highly specific ZFN- mediated functional correction of the alpha 1-antitrypsin gene defect in patient-derived induced pluripotent stem cells or iPSCs. The study is important for several reason, for this the first demonstration and the potential of combining human iPSCs with ZFN-driven gene correction to generate treatments from monogenic diseases.

In addition, analysis of the entire coding sequence of the ZFN-corrected iPSC line revealed that the only modification attributable to the ZFN activity was the targeted and corrected alpha 1-antitrypsin gene. This work further demonstrates the singular specificity that can be achieved using Sangamo's ZFP technology.

The ability to function at the DNA level was such exquisite specificity makes our technology ideally suited for the development of novel therapeutics, targeted diseases in which a single gene has been demonstrated to have a central role.

Before I ask Geoff to give you more details about our future clinical plans for advancement of our CCR5 HIV program, let me ask Ward to summarize our financial results for the third quarter. Ward?

H. Ward Wolff

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, 2011, and I am pleased to review the highlights of those results.

Revenues for the third quarter of 2011 were $1.9 million compared to $2.9 million for the 2010 quarter. The third quarter 2011 revenues were primarily comprised of revenue from Sangamo's collaboration agreements with Dow AgroSciences and Sigma-Aldrich enabling technology agreements and research grants.

The decrease in revenues between years was primarily due to the completion in July 2010 of the amortization period over which the $15 million expanded commercial license fee received from Sigma in October 2009 was recognized as revenue under Generally Accepted Accounting Principles or GAAP.

Total operating expenses for the third quarter of 2011 were $11.4 million compared to $11.7 million for the same period in 2010. Research and development expenses were $7.8 million for the 2011 quarter and $8.8 million for the prior year quarter. General and administrative expenses were $3.6 million for the third quarter of 2011 compared to $2.9 million for the 2010 quarter.

Stock-based compensation expense was $2.1 million for the quarter, was $1.0 million in research and development, and $1.1 million in general and administrative.

For the third quarter of 2011, we reported a consolidated net loss of $9.6 million or $0.18 per share compared to a net loss of $8.7 million or $0.19 per share for the third quarter of 2010.

With respect to the sequential quarters in 2011, our third quarter operating results closely track the results for the first two quarters with slightly lower operating expenses of $11.5 million in Q3 compared to a $11.8 million for both Q1 and Q2.

Turning to the balance sheet, we ended the third quarter of 2011 with $85 million in cash, cash equivalents and marketable securities, and we remain on track to end 2011 with at least $85 million in cash. This is exclusive of any new funding from our partnership, but it does include anticipated cash receipts related to milestones and other contractual obligations from our existing partnership agreements.

Our financing in April provided us with additional capital to bring our ZFP Therapeutic programs to points of optimal value inflection, while strengthening our balance sheet as we evaluate partnership opportunities across our portfolio and maintaining our historical operating perspective of having multiple years of cash burn on hand.

I also want to reiterate guidance from our second quarter call with respect to expected operating expenses and revenue for 2011. We continue to expect 2011 operating expenses to be relatively flat compared to 2010 in the range of approximately $43 million to $47 million for the year and revenues and related cash proceeds to be in the range of $10 million to $12 million this year.

In summary, with respect to finances and operating leverage to support our research and clinical development pipeline activities, I am very pleased to report that the third quarter results, which track to our 2011 operating plan combined with our financing, keeps us in a solid financial position.

We look forward to keeping you updated on our progress. Thank you and I will now turn the call back over to Edward.

Edward O. Lanphier II

Thanks Ward. As you’ve heard, we continue to manage our cash and with our expected fourth quarter revenues, we remain on track to meet our financial objective of ending 2011 with at least $85 million in cash and cash equivalents.

This cash position enabled us to aggressively move our clinical pipeline forward to points of significant value inflection with the aim of establishing partnerships with major pharmaceutical companies for individual programs and program areas.

As I mentioned earlier, in September of this year at ICAAC, we presented data from our SB-728-T studies our lead ZFN genome-editing clinical program, which we’re developing for the treatment of HIV/AIDS. Our product vision for this ZFP Therapeutic is to provide ZFN modified CCR5 negative CD4 T-cells that are protected from viral infection as they no longer express a functional CCR5 receptor yet are capable of mounting an effective anti-HIV immune response, thereby enabling a functional cure for HIV.

To that end, we have been conducting phase 1 clinical trails in different populations of HIV infected subjects to test not only the safety and feasibility of this approach, but to rapidly determine the most appropriate population in which to provide clinical proof of efficacy.

The data presented at ICAAC are consistent with our product vision and provide us with a clear path forward for our next phase of clinical development.

Let me turn the call over to Geoff who will summarize our findings thus far including the new data and give you more information regarding our clinical development plans for this program. Geoff?

Geoffrey M. Nichol

Thanks Edward. ZFN CCR5 receptor T-cell therapy SB-728-T is a novel approach to HIV treatment, designed to provide a functional cure. We’ve been testing the drug in phase 1 clinical trials across the wide range of disease stages not only to establish the safety of the methods, but also to establish the optimal population and conditions that would enable us to most rapidly demonstrate a clinical effect.

Thus the trials began with a single dose study at the University of Pennsylvania in subjects on HAART to have relatively good CD4 T-cell levels at baseline that is greater than 450 cells per microliter. That was followed by our dose escalation study in subjects on HAART who have lower CD4 count at baseline classified as immunological non-responders. Having demonstrated the safety of the approach, we most recently initiated a phase 1/2 study at the highest dose in subjects that were treatment naïve and viremic.

Data presented at the 2011 Conference on Retroviral and Opportunistic Infections or CROI in early March, and most recently at ICAAC from the two phase 1 studies in aviremic subjects have allowed us to make several important observations.

Firstly, SB-728-T treatment is safe and well tolerated in the HIV subjects that have been tested. Secondly, we’ve observed some basic pharmacological parameters for our ZFN-modified T-cell. ZFN-modified CCR5 disruptive cells engraft, expand and don’t just remain circulating in the blood, but traffic normally to sites such as the gut associated lymphoid tissue where that thought to be the principal areas of active HIV replication in subjects on HAART.

In addition, SB-728-T treatment may have positive effect on the health of the overall immune system as judged by several measures that are important to HIV infected individuals. We have observed remarkable increases in total CD4 T-cells following SB-728-T infusion and the great majority of the patients tested in our phase 1 trials.

There is no other treatment that has been shown to do this, to agree that we have observed in these studies.

As a consequence, in the majority of subjects that entered the trials with CD4, CD8 ratios below one, we have observed an improvement in normalization of that ratio.

Finally, we have seen very promising effects on viral load in aviremic subject on HAART that have undergone treatment interruptions following SB-728-T engraftment.

As we described at ICAAC, six subjects were enrolled into cohort 2 at the University of Pennsylvania trial and underwent a 12-week treatment interruption of their antiretroviral medications one month after SB-728-T treatment.

All subjects experienced the expected rise in their viral loads after halting their medication. Interestingly, in three of those subjects, viral load then decreased during the TI, but tend to a 100 fold, and in one subject, fell to undetectable levels before the subject resumed HAART in accordance with the protocol. The development of aviremic is highly unusual during treatment interruptions in HIV patients.

As many of you noticed, particular individual already carried the natural delta32 mutation in one of the two copies of its CCR5 gene, making him a so called, heterozygote for that gene mutation. The advantage of entering this trial as a CCR5-delta32 heterozygote is at further modification as a result of ZFN treatment gives the subject a higher number of cells in which both CCR5 gene to modify and thus the higher percentage of cells that are completely resistant to HIV infection.

Further more, when we calculated the estimated rates of engraftment of the so called biallelically modified cells across subjects during the treatment interruption, we saw a statistically significant correlation with the observed decrease in viral load during the TI.

This observation is entirely consistent with the high purposes under, which we began this program and gives us an important signal as to the threshold of percentage biallelic modifications and engraftments that we may need to achieve, control of viral load in patients whose immune system is maximally reconstituted by HAART therapy.

With our goal of moving this program quickly to a point where we can confirm this observed antiviral effect. We are initiating two new studies that we alluded to after the ICAAC data presentation.

The first study is to recapitulate and further explore our visual observation in HIV infected CCR5-delta32 heterozygote. In this study, which is being added as the fifth cohort to our original SB-728-902 trial, we will enroll up to 20 subjects to around HAART and who will undergo a 16-week treatment interruption one-month after SB-728-T treatment.

This study will as previously re-institute HAART if a subjects CD4 count falls below a certain threshold or viral loads rise too high to a too higher level. But importantly, we’ll also have the provision to delay resumption of HAART if patients are averimic at the end of the treatment interruption period.

Screening of potential CCR5 heterozygote subjects has begun and we will update you after the status of this trial at appropriate medical and scientific meetings as data become available.

The second trial that we plan to initiate takes the observation of enhancing engraftment of biallelically modified cells much further and potentially applies to the entire population of HIV infected patients. The rationale behind the study design is to use what is called a lymphopenic preconditioning regimen that transiently depletes T-cells in the subject and not only makes space from new cells, but sets up a response in the body that signals remaining cells to rapidly multiply to address this depletion.

We plan to enroll subject in this engraftment enhancement study that are on HAART. Immediately prior to administration SB-728-T, we will precondition our immune systems to reduce the lymphopenics state, stimulating the transfused ZFN-modified cells to undergo significant growth and expansion. This is expected to enhance engraftment of the modified cells and as a consequence, the engraftment of biallelically modified cells.

As I mentioned, lymphopenic preconditioning has been effectively used in other reductive T-cell settings and has resulted in significantly enhanced engraftment of the transplanted autologous T-cell. For example, me and Dr. Carl June’s work on chronic lymphocytic leukemia that was recently published in the New England Journal of Medicine, he observed up to a 1,000 fold expansion of the modified T-cells infused after conditioning.

The agent that we plan to use is routinely used to treat autoimmune conditions with acceptable safety and tolerability and has also been previously used in subjects with HIV resulting in the induction of temporary lymphopenia with no long-term effect on the CD4 count. The proposed clinical trial design will involve aviremic subject on HAART.

We will conduct a dose escalation phase to establish safety and efficacy of the engraftment enhancement and will subsequently expand enrollment at a well tolerated lymphopenic dose to evaluate effects on viral load.

All subjects will undergo a treatment interruption following the expansion of SB-728-T, again with a provision for HAART resumption if there are aviremic at the end of the TI.

We are currently consulting with our clinical advisors on the details of the design of the trial. Subject to a new regulatory filing, we anticipate enrollment in the dose escalation cohorts to begin in the first half of 2012.

Again, we will update you on the status of this trial at appropriate medical and scientific meetings as data become available.

Finally, I’d like to update you on our SB-728-1002 trial. As we have discussed, the recent ICAAC data suggest that subject that have higher biallelic engraftment of CCR5 modified cells, experience better reduction in viral loads and the patients with the best reconstitution of their immune system are those most likely to make best use of the modified CD4 cells.

As a result, we believe that the best proof of concept population is subject on HAART with maximal immune reconstitution where biallelic modification can be greatly enhanced, whether by treating heterozygotes or using a preconditioning regimen. The time for implementing this enhanced strategy is opportune.

We are just completing accrual of the 1002 study having enrolled 21 subjects. We will present data from the study and appropriate meeting in 2012 when we have more prolonged follow up data on the entire cohort.

With that I’ll turn the call back over to Edward.

Edward O. Lanphier II

Thanks Geoff. As you referred today our ZFP technology platform provides us a powerful highly specific tool to address diseases for which therapeutic gene target has been clearly defined.

Much of our developing therapeutic platform is focused on unmet medical needs that fits exactly this profile. Our goal remains to establish ZFP Therapeutics as a new and highly differentiated class of human pharmaceuticals moving programs forward initially on our own but eventually with suitable corporate partners and ultimately forward integrating to carry appropriate programs to commercialization on our own.

In addition to our HIV clinical program, we have an active research and pre-clinical programs in monogenic diseases including the hemophilias and hemoglobinopathies, Huntington's disease and several other unmet medical needs.

We look forward to keeping you informed of our progress in future calls and presentations. To that end we will be presenting at Lazard Capital Markets, 8th Annual Healthcare Conference in New York on November 15. This completes our prepared comments; I would now like to open up the call for your questions.

Question-and-Answer Session

Operator

(Operator Instructions) Our first question comes from Charles Duncan of JMP Securities. And your line is open.

Charles Duncan – JMP Securities

Hi guys. Thanks for taking my question.

Edward O. Lanphier II

Good afternoon.

Charles Duncan – JMP Securities

Good afternoon. Edward, my first question is regarding the two new trials that you outlined. First of all, thank you for the clarity on those. It looked to be pretty interesting but Geoff mentioned a new regulatory submission and I’m not sure I’m clear on what would be required to get those trials going in and if therein call it, you said first half of 12 is likely back-end loaded.

Edward O. Lanphier II

Let me speak at a very high level and then certainly Geoff can add color. In terms of the heterozygote study that is will be cohort 5 of our existing protocol and I guess Geoff outlined, we’ve begun screening subjects on that study. But we’ll require a new protocol submission is the engraftment enhancement study at that different protocol.

Charles Duncan – JMP Securities

Sure.

Edward O. Lanphier II

And we expect as Geoff outlined to submit that and initiates screening and accrual that trial in the first half of next year. Beyond that Charles I hope is that direct to your question or make sure...

Charles Duncan – JMP Securities

Yeah. That answers my question. And I guess my second question is regarding these two studies in some ways they appear to be hypothesis generating, but also it seems like the answers to them may help them form a path forward. Could you help us understand whether or not you think in 2012, you’re going to be in a position to design perhaps a randomized control trial that could or a path to market that would be fairly definitive?

Edward O. Lanphier II

All start at a very high level and Geoff can certainly chime in. Our goal here in these two studies is to aggressively pursue the signal that we have seen from the Phase I work that we have presented at ICAAC. And I think these studies are designed to do exactly that; if successful the goal would be to utilize the data from these to have a clear sense of the path forward to commercialization. Geoff do you want to maybe add to that on these.

Geoffrey M. Nichol

Yeah Charles, you know I would echo that. I think there is a couple of purposes to the study. One is really to confirm proof of principle and proof of concept, so that is definitely the first stage. I think the study that we’ve done to-date have been to some extent hypothesis generating and they have generated the hypothesis that actually you need. The best immune reconstituted patients and that usually, and that implies that they need to be on how to let that occur and maximize biallelic modification engraftment levels.

So I think we’re going to try to confirm that strategy in terms of proof of principle, I would agree that that then leads onto control studies almost certainly to then confirm that hypothesis, sounds that feels to me like a pretty standard development paradigm here. And the timing that you asked, I don’t think we have guided to the timing yet.

Charles Duncan – JMP Securities

But is it possible that could be a 2012 event towards the end of it or maybe…

H. Ward Wolff

I think that at this point Charles, the guidance is that we expect to start both of these trials in the first half and we will definitely update before we present data at a clinical meeting. But I think I’ll just put it out myself; I'm reluctant today to get too far out in front of saying when and where we’d be presenting data for trial that we haven’t really even begun yet.

Charles Duncan – JMP Securities

Yeah, that make sense. With regard to the other programs that are possible, the monogenic or genetically defined diseases; in 2012 would you anticipate any increased visibility on what the next program could be out of that effort?

Edward O. Lanphier II

Yes absolutely, and you will see very direct as we move into 2012, very direct and I will add to and I’ve always said, data driven guidance on our prioritization of programs that we will be moving forward in the monogenic disease space.

Charles Duncan – JMP Securities

Or perhaps maybe IND-enabling type work?

Edward O. Lanphier II

Well again, let’s be positive and say to your earlier question that we will be very much out in front on discussing what the next steps are there.

Charles Duncan – JMP Securities

Then if I could ask one last question for Ward with regard to the cash guidance. It seems really if I add up the revenue for the year, it seems like revenue in the fourth quarter could exceed that in the third quarter. Is it usual that at the end of the year you anticipate some sort of revenue milestone payment or something or…?

H. Ward Wolff

Right. It is correct, Charles, we – the back quarter particularly in 2011 is heavily skewed to a number of milestones or other contractual obligations. So we have revenue at least expected revenue for Q4 that relates to the vast minimum annual royalty stream to the consulting we’re doing for DAS to our milestones, one milestone with JDRF and additional funding from both CIRM and Huntington’s programs. So at this point, we're expecting that those revenues will effectively offset the burn for the quarter.

Charles Duncan – JMP Securities

You talked about two years of cash, does that – I guess I must assume that you have an idea of what the expense would be for these development efforts next year and that will be roughly on the same order of magnitude as this year?

H. Ward Wolff

Right. We haven’t given guidance specifically for next year, but I think it's fair to say that we expect as of right now that our cash consumed in 2012 will be at or below the 2011 levels. And I don't think we said two years of cash, but in any of that we view multiple years if we track to our historical burn in the 20 million to 25 million names on an annual basis.

Charles Duncan – JMP Securities

Okay. Thanks guys for taking my questions.

Edward O. Lanphier II

Thanks, Charles.

Operator

Thank you. Our next question in queue is from Ted Tenthoff from Piper Jaffray. Your line is open.

Ted Tenthoff – Piper Jaffray

Great, thank you. Charles went through a lot of the questions; just to confirm the data that you’ll be showing in the treatment naive patients that was about 13 patients that was enrolled and you will report that by year-end?

Edward O. Lanphier II

So no, the 1002 trial that Geoff discussed that we have accrued 21 subjects on that trial and we expect to present the full cohort in 2012.

Ted Tenthoff – Piper Jaffray

Okay. Pardon me; now that 21 does not include the new cohort 5. Is that correct?

Edward O. Lanphier II

That's correct. The subject is on the 1002 trial, which is the treatment naive study.

Ted Tenthoff – Piper Jaffray

Okay, perfect. And then with cohort 5, the goal is to enroll about 20 headers I get down from 32 invitations right?

Edward O. Lanphier II

The protocol provides for up to 20. That’s right.

Ted Tenthoff – Piper Jaffray

All right, awesome. Well, I think there’s a really interesting approach. I’m looking forward to seeing that data next year.

Edward O. Lanphier II

Thanks Ted.

Operator

Thank you. (Operator Instructions) Our next question is from Liana Moussatos from Wedbush Securities. Your line is open.

Liana Moussatos – Wedbush Securities

Thank you. Can you talk about any safety issues with the lymphopenic preconditioning that you are going to use?

Edward O. Lanphier II

Hi, Liana

Liana Moussatos – Wedbush Securities

Hi, Edward

Edward O. Lanphier II

Yes, we’re delighted to, I mean this is certainly Geoff unveil various expertise. I think the intent was, and I’ll obviously turn it over to Geoff to comment further, but the intent was in the script to go through some of the history of this approach and the data that have been generated, but Geoff anything you want to amplify from beyond the script.

Geoffrey M. Nichol

Yeah Liana, just again to reiterate that this approach is well used, the agent, but you can use in the setting, had been used in non-molecule setting such as autoimmune disease for a long-time with an adequate safety profile, and then B, it had also been used in HIV patients. And finally this will be a dose escalation study. So we don’t anticipate any significant issues on that front.

Liana Moussatos – Wedbush Securities

Okay, no changes and infections or anything like that from this?

Geoffrey M. Nichol

No.

Liana Moussatos – Wedbush Securities

Okay. All right thank you.

Edward O. Lanphier II

Thanks Liana.

Operator

Thank you. And I am showing no further questions from the phone lines.

Edward O. Lanphier II

Great. We would 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. We will be available later today if there are any follow-up questions.

Operator

Ladies and gentlemen, thank you for joining today’s conference. This does conclude the program. And you may now disconnect.

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