Sangamo Biosciences, Inc. (NASDAQ:SGMO)
Q1 2014 Earnings Conference Call
May 6, 2014 5:00 PM ET
Elizabeth Wolffe – VP, Corporation Communications
Edward Lanphier – President and CEO
Ward Wolff – EVP and CFO
Geoff Nichol – EVP, Research and Development
Roy – Piper Jaffray
Heather Behanna – JMP Securities LLC
Good afternoon, and welcome to the Sangamo BioSciences Teleconference to discuss First Quarter 2014 financial results. This call is being recorded. I will now pass you over to the coordinator of this event, Dr. Elizabeth Wolffe, Vice President of Corporate Communication.
Thank you, Michelle. Good afternoon, and thank you for joining Sangamo’s management team on our conference call to discuss the Company’s First Quarter 2014 financial results. Also present during this call are several members of Sangamo senior management, including Edward Lanphier, President and Chief Executive Officer; Ward Wolff, Executive Vice President and Chief Financial Officer; Geoff Nichol, Executive Vice President of Research and Development; Philip Gregory, Senior Vice President of Research and Chief Scientific Officer; and Dale Ando, Vice President of Therapeutic Development and Chief Medical Officer.
Following this introduction, Edward will highlight recent activities and the significant events from the past quarter. Ward will then briefly review first quarter financial results as well as our financial guidance for 2014. Geoff will provide an update on our ZFP therapeutic program. And finally Edward will update you on our goal for 2014 and beyond. Following that, we will open up the call for questions.
As we begin, I’d like to remind everyone 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 overtime. By discussing our current perception of the market and the future performance of Sangamo with you today, we are not undertaking any obligation to provide updates in the future.
Actual results may differ substantially from what we discussed 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 the 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 of the company’s operations to differ materially from those contained in our projections of forward-looking statements.
Now, I would like to turn the call over to Edward.
Thank you, Liz, and thank you all for joining us for our conference call to discuss our first quarter results for 2014, as well as recent progress and future plans for the development of our ZFP therapeutic’s pipeline.
2014 is a very important year for Sangamo and we began with a very eventful first quarter. As most of you are aware, in early January, we announced an important partnership with Biogen Idec that will help accelerate our hemoglobinopathies program through clinical trials and into commercialization.
In addition to the economics of the agreement which included a $20 million upfront payment as well as reimbursement from Biogen for our internal and external research and development program related costs, the program further validates our ZFP genome editing platform as a transformative technology capable of genetic cures.
Over the past couple of years, there has been a growing interest in the area of genome editing. As this collaboration demonstrates, there is a clear understanding that our zinc finger nuclease platform with its proven specificity and efficacy and growing clinical safety database is, and I believe, will remain the gold standard in the genome editing space.
Biogen Idec certainly recognize these truths and as such are tremendous partner for our beta-thalassmia and sickle cell disease programs and we are delighted to be working with them to bring this potential curative treatments to patients.
On the clinical front in early March, our HIV program receives significant attention following publication in the New England Journal of Medicine of data from our first Phase I clinical trial.
In addition, the paper came out during the week at one of our most important HIV meetings of the year, the Conference on Retroviruses and Opportunistic Infections or CROI at which we present a data from our recent clinical studies of SB-728-T.
Together these two events created a great deal of visibility around our efforts to develop a functional cure for HIV and AIDS. Later on this call, I’ve asked Geoff to briefly summarize the New England Journal of Medicine paper and its importance on our program, the recent CROI data and provide you with more details regarding our plans for our HIV program going forward.
Finally, near the end of the first quarter, we completed $100 million follow-on financing. We sold $4.4 million shares of common stock at a public offering price of $22.50 per share which resulted in net proceeds to Sangamo of approximately $94 million.
To state the obvious, the financing gives us much greater flexibility to accelerate our process of forward integration as well as continue to evaluate and acquire products and technologies such as delivery technologies which will enhance the safety, efficacy and value of our ZFP therapeutics.
In addition, as we advance products to a preclinical testing for submissions of multiple IND applications and subsequent clinical studies, we see a distinct advantage in our building out our internal capabilities in AAV and MRNA GMP manufacturing.
So collectively, our recent partnership and our recent financing have had a very positive impact on our financial situation both for this year and as we successfully meet our development goals for the years to come.
On that note, let me hand the call over to Ward for an update on our first quarter 2014 financial results as well as our updated financial guidance for 2014. Ward?
Thank you, Edward, and good afternoon, everyone. As you know, after the close of the market today, we released our financial results for the first quarter ended March 31, 2014 and I am pleased to review the highlights of those results. Revenues in the first quarter of 2014 were $8.1 million compared to $4.6 million for the same period in 2013.
First quarter 2014 revenues were comprised of revenue from Sangamo’s collaboration agreements with Shire, Biogen Idec, Sigma-Aldrich and enabling technology agreements as well as approximately $0.5 million of revenue from research grants.
The increase in collaboration agreement revenues was primarily due to the company’s collaboration and license agreements with Shire and Biogen. Sangamo recognized $5 million of revenues related to research services performed under the collaboration agreement with Shire in the first quarter and $400,000 of revenues related to research services performed in the collaboration agreement with Biogen in the same period.
In addition, pursuant to the agreements entered into with Shire in January 2012 and Biogen in January 2014, Sangamo received upfront payments of $13 million and $20 million respectively which are being recognized on a straight-line basis of the initial six-year research term for Shire and 40 months for Biogen.
The company recognized that $0.5 million of the Shire upfront payment and $700,000 of the Biogen upfront payment as revenue for the first quarter of 2014.
Total operating expenses for the first quarter of 2014 were $15.7 million compared to $11.5 million for the same period in 2013. Research and development expenses were $12 million in the first quarter of 2014 and $8.2 million for the prior year quarter.
The increase was primarily due to increases in external research expenses associated with our preclinical programs, personnel related expenses including stock-based compensation and professional services expenses. General and administrative expenses were $3.6 million in the first quarter of 2014 and $3.3 million for the same period in 2012 – excuse me, I should say 2013.
Non-cash stock-based compensation expense was $1.9 million for the quarter of approximately $1.1 million in research and development and $800,000 in general and administrative.
For the first quarter of 2013, we reported a consolidated net loss of $7.6 million or $0.12 per share compared to a net loss of $6.9 million or $0.13 per share for the first quarter of 2013. Turning to the balance sheet, I am pleased to report that as a result of our March financing and the upfront payment from Biogen, we ended the first quarter of 2014 with $244.2 million in cash, cash equivalents, short-term investments and interest receivable.
Our net cash provided by operating activities was $11.4 million for the quarter. We are updating our financial guidance for this year with respect to our year-end cash. We expect to have cash and investment balances of at least $225 million at the end of 2014 inclusive of research, funding and milestones from Shire and Biogen, but exclusive of any new funding from a partnership or other sources.
We are reiterating our earlier guidance with respect to 2014 operating expenses and revenues. We expect operating expenses to be in the range of $65 million to $70 million and revenues in the range of $45 million to $50 million. Revenues include partial recognition of the upfront payment and research funding for internal and external research program related cost from Biogen and partial recognition of the upfront payment, research funding and potential milestone payments from Shire.
Thank you and I will now turn the call back over to Edward.
Thanks, Ward. As you have heard, we ended the first quarter of 2014 with approximately $245 million which relative to our burn rate is a very strong cash position. We also believe that this balance sheet strength will enable us to complete our ongoing clinical trials and to bring up to eight new products to INDs by the end of 2015.
These new drug applications include both programs partnered and funded by the Shire and Biogen as well as our proprietary programs in lysosomal storage disorders that has significantly benefited from our partner-funded work.
As Ward mentioned, as we have previously discussed, we are guiding to higher revenues and operating expenses this year as we ramp up activities to move our first four of these programs IND applications. In 2014, our goal is to file IND applications for our Shire partner and programs in Hemophilia A and Hemophilia B which will trigger a total of $8.5 million in milestones for each program.
These IND applications and the IND for our Biogen partner program in beta-thalassemia are most likely to be filed towards the end of 2014. However, we envision that the IND application for our HIV program in stem cells is likely to be filed in mid 2014. This program will be our first ZFN modified stem cell application to enter the clinic and we’ll use MRNA delivery of the ZFNs, but we are also evaluating in T-cells in our ongoing HIV clinical trials.
Speaking of our SB-728 HIV program, I’ve asked Geoff to briefly describe the data from our recently published New England Journal of Medicine paper, more recent data from the latter trials that were presented at CROI in March and our plans for the next stage of this program. Geoff?
Thanks, Edward. There were two significant clinical data releases from our SB-728-T program in the first week of March. The first on March 5 was the publication in the New England Journal of Medicine, our Phase 1 clinical data from one of the first studies of SB-728-T our T-cell approach to the treatment of HIV AIDS.
The data presented in this high profile publication set the scene for the following days presentation of some of the most recent clinical data from the latest SB-728-T trials at the Conference for Retroviruses and Opportunistic Infections or CROI.
As you know, our goal with this approach is to modify the immune system of an HIV infected individual to enable functional control of the virus, enabling their immune system to suppress levels of replicating virus in the blood without the use of anti-retroviral medications or ART.
To achieve this, we are using our ZFN technology to disrupt the CCR5 gene in CD4 T-cells. The aim is to make this critical immune system cells resistant to infection and destruction by HIV so that they can participate with the rest of the immune system in overcoming the virus.
Based on the data that we have obtained from a clinical trial thus far, we believe that with sufficient numbers of our modified cells and the appropriate immunological background, this goal is achievable.
We also have data to indicate that in contrast to ART and immunological approach such as SB-728-T may also be able to erode the all important bio reservoir and make the idea of a functional cure a reality.
The New England Journal paper described data generated in the Phase I trial that we carried out in collaboration with Carl June and Pablo Tebas at the University of Pennsylvania.
Briefly this was an open-label study of a single dose of SB-728-T in 12 HIV infected subjects whose virus was well controlled by ART. The primary objective of the study was to assess safety and tolerability of the administration of a single dose of SB-728-T.
Secondary outcomes included measures of immune constitution and HIV resistance. The study evaluated treatment in two cohorts with six subjects each, subjects in Cohort 1 were immune respondents, individuals who had demonstrated adequate recovery of CD4 T-cells after ART. The subjects in Cohort 2 are circled immunological non-responders, individuals who had demonstrated inadequate recovery of CD4 T-cells after ART.
In the study, T-cells from HIV’s interruption from ART of up to 12 weeks, we found and have continued to observe in subsequent clinical trials that ZFN modified T-cells are well tolerated when infused and the treatment is associated with an increase in the levels of total circulating CD4 T-cells.
The modified cells readily engrafted and we’re able to track it throughout the body to key sites of HIV persistence such as the gut associated lymphoid tissue. The data also demonstrated that the modified cells persist and more over appears to have a selected advantage showing a preferential survival compared to unmodified cells when exposed to HIV during a planned interruption of ART.
Importantly, the clinicians noted that SB-728-T treatment was associated with decreased viral loads in several subjects who were taken off their ART. This group included one subject who experienced the longest delay in rebound of viral load when ART was withdrawn and achieved a decreased to undetectable levels during the 12-week period. This subject was later found to carry a natural mutation of CCR5 Delta 32 in one of the two CCR5 genes making the individual a CCR5 Delta 32 heterozygote.
Thus, following exposure to the ZFNs targeting CCR5, this subject had a greater percentage of T-cells that were modified at both copies of the CCR5 gene so called biallelic modification and were therefore fully resistant to HIV infection.
Preliminary analyses suggested that the levels of circulating cells with biallelic modification of CCR5 may correlate with control of viral load. This observation made sound scientific sense and we subsequently initiated two important clinical studies to further study this relationship.
The first trial, SB-728-902 Cohort 5 enrolled CCR5 Delta 32 heterozygotes to continue to evaluate this population. A second trial, SB-728-1101 enrolled subjects that don’t necessarily carry the advantageous CCR5 mutation, but who is part of the protocol undergo a preconditioning with the drug Cytoxan.
Cytoxan preconditioning has been widely used in the development of adoptive T-cell therapies for cancer to increase the numbers of modified circulating T-cells. In our application, we are using the drug to increase the proportion of circulating T-cells that is ZFN modified.
On March 6, Dr. Gary Blick, one of our principal investigators presented the most recent data from a Cytoxan dose escalation study of CROI. He also updated the status of a subject from Sangamo’s SB-728-902 Cohort 5 study who had demonstrated sustained control of viral load noting that at the time of the presentation, the individual had controlled their viral load for over 31 weeks without ART and remained on a treatment interruption.
Data from the Phase 1 and 2 clinical trial SB-728-1101 demonstrated the increasing dosage of Cytoxan preconditioning trials with single infusion of SB-728-T led to a dose-dependent increase in both engraftment of CCR5 modified cells and notable increases in total CD4 cells above the baseline.
We observed the greatest decrease in viral load, a drop of 1.9 logs from peak during a treatment interruption from ART at the highest Cytoxan dose of 1 gram per meter squared at doses up to a gram per meter squared, the drug and SB-728-T treatment was shown to be safe and well tolerated in HIV infected subjects. As expected, the most common side effect of Cytoxan, nausea and vomiting increased with dose necessitating the use of prophylactic antiemetics.
The 1101 trial has been extended to study six additional subjects in order to determine the optimal Cytoxan dose. Early data from this cohorts suggest that an optimal dose will lie between 1 and 2 grams per meter squared as more Cytoxan side effects particularly more severe symptoms of nausea were observed at 2 grams per meter squared.
We now better understand the baseline, immunological parameters that are required for viral control. These include the threshold level of T-cells that have undergone [indiscernible] modifications, the capability of the immune system to respond to the virus and the size of the viral reservoir.
We also know that the inflammatory status of the HIV infected individual as identified by cell surface marker in gene expression profiles of immune system cells is important for the successful engraftment of SB-728-T.
With this information on hand, as we have previously guided, we will treat a further 12 subjects at the optimal Cytoxan dose.
In addition having established that the SB-728-T treatment is safe and well tolerated, we’ve also developed a new proprietary manufacturing process to use, a messenger RNA delivery of the ZFNs used in CCR5 modification of the T-cells.
This modification to the protocol provides both process and cost saving advantages over viral delivery which will enable re-treatment if necessary and offers the potential CCR5 biallelic modification.
We intend to evaluate messenger RNA delivery in the subset of these 12 subjects and to enroll in complete treatment of all subjects by the end of 2014. Overall the data presented at CROI and published in the New England Journal of Medicine [indiscernible] support our development program for SB-728-T potential functional cure for HIV AIDS.
This is a very exciting time for Sangamo. We’re making good progress in our HIV program both in T-cells and as we prosecute the expanded Cytoxan preconditioning studies and in stem cells as we move towards the filing of an IND application for this program mid-year.
We’re also working hard towards our goal of filing seven additional INDs by the end of 2015.
I look forward to updating you on our progress with these ambitious goals on future calls. And with that, I will turn the call back to Edward.
Thanks, Geoff. So as you have heard, we will complete normative treatment of our Phase II clinical trial in our SB-728-T HIV AIDS program by the end of this year and have a new IND file application file for our HIV stem cell approach around the middle of this year. With positive data from either of these ongoing studies, we plan to partner our HIV program for further development and commercialization as we increasingly look forward – look to forward integrate in other therapeutic areas.
More specifically, as we begin to forward integrate into later stage clinical development, GMP manufacturing and ultimately commercialization, we are successfully leveraging the work and advancements that have been funded by our partnered programs and are able to use these advances to accelerate the development of our own proprietary programs.
We are largely focused on monogenic diseases, diseases in which there is no ambiguity between the mistake in the gene and the disease. Initially we are pursuing lysosomal storage disorders many of which are currently being treated with frequent enzyme replacement therapy.
These disorders provide opportunities in which technical proof of concept can be obtained relatively early in preclinical animal models and small clinical studies. In addition, our therapeutic approach and to providing genetic cures for these monogenic diseases require a relatively modest initial investment in GMP manufacturing infrastructure.
Our recent financing gives us the resources to accelerate this process and to internalize this key core competency rather than rely exclusively on contract manufacturing organizations.
We will also continue to evaluate and in license or acquire technologies that are synergistic with or enabling for the development of our ZFP therapeutics.
This is made possible by the fact that we are in very good shape financially. We ended 2013 with approximately $132 million and expect to end 2014 with cash and cash equivalents of at least $225 million. This ascends that we need our goals of filing INDs for our hemophilia program which are partnered with Shire, but does not assume any partnerships or financings.
We also intend to file an IND on our Biogen partner program in beta-thalassemia by the end of this year. The first milestone for that program of $7.5 million which we expect to receive in 2015 is associated with the Phase 1 trial. Needless to say we are looking forward to one of the most exciting periods in the company’s history and we’re looking forward to keeping you informed of our progress.
To that end, we will be presenting at the Deutsche Bank Healthcare Conference in Boston later this week. The Bank of America Healthcare Conference in Las Vegas next week, the UBS Global Healthcare Conference in New York in the following week.
We will also be presenting data from a variety of our programs and research collaborations in monogenic diseases, HIV, T-cell editing and novel [ph] ZFP delivery methods at the Annual Meeting of the American Society of Gene and Cell Therapy in Washington DC from May 21 to 24.
This completes our prepared comments. I would now like to open up the call for your questions.
(Operator Instructions) Our first question comes from Charles Duncan of Piper Jaffray. Your line is open. If your telephone is muted, please unmute.
Roy – Piper Jaffray
Hi. It’s Roy in for Charles taking the question.
Roy – Piper Jaffray
Hi. Sorry I missed a lot of the call. And I think maybe Ed addressed some of this at the beginning, but I had a couple of questions on the AAV platform I guess. I just wondered if you could – and if you’ve addressed this just skip it and I’ll read the transcript. But if you can maybe discuss how sound the IT [ph] is or is it more than an acquired knowledge trade secret kind of thing? Do you think it’s something that it will be commoditized or should investors be watching for maybe key future litigation events?
So, Roy, I’m going to try and repeat the question. You’re interested in AAV and in particular you are interested in the intellectual property environment around AAV, is that right?
Roy – Piper Jaffray
Yes, I guess how strong your position is. It is really dependent on the patent or is it trade secrets knowledge?
So I’ll start with the intellectual property and I’ll be happy to talk a little bit about on the manufacturing side. And then I’m delighted for any of my colleagues to chime in.
Sangamo has freedom to operate in essentially three AAV vector serotypes. And there are specifics around each one of these, but at the highest level involve AAV5, AAV6 and then AAV2 through our acquisitions of Ceregene.
And there are several other serotypes as you and I’m sure people on the call are aware and those serotypes have patents of both pending and issued around this. But our focus is on the area of AAV2, AAV5 and AAV6.
And again, we can dive into some of the biology around those and why we think they have potential differences and so on.
I guess I’m not going to comment on litigation in the space except to say that there are patents filed broadly across multiple AAV serotypes. In terms of non-patent intellectual barriers to entry, I certainly think that there are real established processes for manufacturing and established released criteria AAV has been probably put in vitro into more patient than any other vector system. And so I think there are – if Geoff or Philip or Dale want to add anything to that?
Yes, it’s Geoff. I mean, I don’t have a lot to add to what Edward has said. We have freedom to operate to – in AAV serotypes that are able to do what we need them to do for our programs, but obviously we derive our exclusivity from the technology that the AAVs deliver.
So delivery is one thing, but the ZFN provides – and the ZFP technology provides us with our unique, very strong intellectual property position to the very unique therapeutic benefits that this technology brings.
Yes. Thanks for the Geoff [ph].
Roy – Piper Jaffray
And then really a question I guess, but if you could help me educate me here too, but the requirements for preclinical and Phase I for these constructs, I mean once you get something into the albumin locust in the liver or certain change, do you need to go back and rerun a full preclinical and Phase I programs to target difference of that locust or do you think you can just go in the Phase II, that’s potentially pre-registrational maybe?
Let me repeat the question and make sure we’re right. So you’re asking me if we have an IND for the albumin locust for factor IX and go through all the toxicology studies and human safety and found the factor IX. You’re asking me if we can skip all of that when we start factor XIII or [indiscernible] or anything else we want to insert into the albumin locust. Is that the question?
Roy – Piper Jaffray
Yes, it’s essentially just skip the patient, correct.
Yes. My short answer is no. We don’t think we can skip those things. It’s a different product. Do I think we can have a lot of confidence about the toxicology studies associated with the zinc finger nucleases because those were used again and again at the same side, I do.
But each one of these is a new product, a new IND and it’s going to require a new IND. So with that said, again, I’m delighted for Geoff or Philip or Dale to comment further on that answer. Either I’m completely no and they don’t want to say so in public or they’re in table pounding agreement. Roy I’ll let you choose.
The table is pounding here.
Roy – Piper Jaffray
Sounds good, thank you.
Sure, Roy. Thanks.
Our next question comes from Heather Behanna of JMP Securities. Your line is open.
Heather Behanna – JMP Securities LLC
Hi. Congrats on all the progress in the first quarter.
Thanks, Heather. It was a very busy but very productive quarter.
Heather Behanna – JMP Securities LLC
I just have a couple of clarifying questions. One is on the use of MRNA in the T-cells. Is that protocol already accepted or is that something that you have to would go hand in hand with the IND for the stem cell approach?
Again, I’ll start and Geoff and Philip and Dale are all here and they can comment. It would not go hand in hand with the stem cell IND. That’s a separate IND. We do know that it’s a new process. It requires additional filings, but we do not expect that to be a rave limiting step.
Geoff or Philip, you want to comment further on that?
I think again, just to echo Edward, we’re making good progress. It is a separate IND. But obviously a lot of issues, a lot of the points that the MRNA product will have relate very strongly to the package that we have developed towards the antiviral approach.
So not completely similar, but significant similarities and we’ll tell you more as our progress continues along that path.
Heather Behanna – JMP Securities LLC
Great. And do you think we’ll be getting any interim looks from the Cytoxan cohorts as via professors or do you think that’s a 2015 event?
Well, the easiest guidance, Heather, is to say it’s a 2015 event. I think that’s what we’ve said in the past. And I think that’s the most reasonable response at this point.
With that said, we have presented relatively regularly at Idec and at CROI and those meetings offer good opportunities to continue to update on the program broadly.
Heather Behanna – JMP Securities LLC
Great. And then just if you’ll add a little bit more on the manufacturing that we’ve been talking about and bringing things in house. Is this something that would require you to expand facilities? Are you working into that or what’s involved in bringing in the GMP process for the RNA and for AAV and for everything else?
Yes and it is an expansion of space for us. We’re looking at, at least two different approaches, one where we’d extend in our existing site or two where we would acquire our license facilities that are already up and running, potentially being less expensive and faster.
But yes, it will require additional space. And I will say the financial guidance that we’ve given includes our efforts to continue to build out internal GMP manufacturing capabilities.
Heather Behanna – JMP Securities LLC
Fantastic. Thank you so much.
(Operator Instructions) I’m showing no further questions. I’ll return the call back over for any closing remarks.
Thank you very much. We’d like to thank you for joining us and we look forward to speaking with you again when we release our second quarter 2014 financial information. We will be available later today if there are any follow-up questions.
Ladies and gentlemen, thank you for participating in today’s conference. This does conclude the program and you may all disconnect. Everyone, have a great day.
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