Regulus Therapeutics' CEO Discusses Q2 2013 Results - Earnings Call Transcript

Aug.13.13 | About: Regulus Therapeutics (RGLS)

Regulus Therapeutics Inc. (NASDAQ:RGLS)

Q2 2013 Earnings Conference Call

August 13, 2013 17:00 PM ET

Executives

Amy Conrad - Director, IR & Corporate Communications

Kleanthis Xanthopoulos - President & CEO

Neil Gibson - Chief Scientific Officer

Dan Chevallard - VP, Finance & Accounting

Analysts

Bill Tanner - Lazard Capital

Chuck Whitesell - BMO Capital

Simos Simeonidis - Cowen & Company

Alan Carr - Needham & Company

Operator

Good afternoon, ladies and gentlemen, and welcome to the Regulus Therapeutics Second Quarter 2013 Conference Call. My name is Jamie and I will be your coordinator today. I would now like to turn the call over to Amy Conrad, Director, Investor Relations and Corporate Communications. Please proceed.

Amy Conrad

Good afternoon and thank you for joining us. On behalf of Regulus Therapeutics I would like to welcome everyone to our conference call for the quarter ended June 30, 2013. I hope you have all had chance to review today’s press release. If you have not and you need a copy you can visit our website at www.regulusrx.com.

Joining me on today’s call are Kleanthis Xanthopoulos, PhD, President and Chief Executive Officer; Neil Gibson, PhD, Chief Scientific Officer; and Dan Chevallard, Vice President, Finance and Accounting. Dan Chevallard joined us in early December, 2012 and previously held senior roles in corporate finance, accounting and financial reporting as a Corporate Controller and Senior Director of Finance at Prometheus Laboratories. Prior to that Dan began his career as a Senior Financial Auditor at Ernst & Young.

During today’s call, Kleanthis will provide introductory remarks and some general context. Dan will summarize our second quarter 2013 financial results and Neil will provide an update on our microRNA program. Following your questions, Kleanthis will wrap up the call.

Before we begin, I would like to remind you that this call will contain statements concerning Regulus’ future expectations, plans and prospects, which constitute forward-looking statements for the purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in our quarterly report on file with the SEC.

In addition, any forward-looking statements represent our views only as of the date of this webcast, and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements.

At this time, I would like to turn the call over to Kleanthis.

Kleanthis Xanthopoulos

Thank you, Amy. Welcome and thank you everyone for joining us this afternoon.

The first half of this year has been very exciting for Regulus. We are pleased with our significant progress to-date on both the scientific and business fronts.

Let me begin by touching on our most recent accomplishment on the business front. Last month, we successfully completed a public offering that bolstered our balance sheet to $129 million on a pro forma basis and increased our current run rate into 2017. We believe these rates will enable us to accelerate our Road to the Clinic strategy that will also enable us to appropriately expand our microRNA therapeutic pipeline.

As a reminder, our Road to the Clinic strategy which we launched in February is focused on clinical candidates and the overall advancement of our microRNA pipeline in 2013. We made good progress here and have already accomplished all but one of our stated goals.

First, we projected that we would nominate two candidates for clinical development this year. RG-101, a GalNAc conjugated anti-miR that targets 122 for the treatment of chronic hepatitis-C virus infections. These are first microRNA candidates that will enter into the clinic in the near term.

This program is very important for us. If we execute on our timelines, we may be able to demonstrate human proof of concept with the compound RG-101 by the end of next year 2014.

We believed human proof of concept may validate our technology platform and may further validate microRNAs as the next wave of the (inaudible) RNA therapeutics could demonstrate success. Importantly, these data also will be pivotal in Regulus’ maturation to a stable biopharmaceutical company focused on creating transformative [medicines] [ph].

The second goal under our Road to the Clinic strategy is to enter the year with at least $60 million in cash to support the preparation of our clinical activities. Today, we are pleased to report that we will exceed our prior cash guidance because of our prudent cost management and primarily the most recent offering. Therefore, we have revised our guidance to end 2013 with approximately $110 million in cash. We view our healthy balance sheet as an important asset that will facilitate the growth of the company to expand our current goals and allow us for strategic optionality.

Our last goal under our Road to the Clinic strategy is that we would be in a position to file our first applications with regulatory authorities in 2014. We’re on track to meet these goals. Because of the proper execution of these stated goals, we’re well-positioned to hit our final goals on the Road to the Clinic and expect to nominate a second microRNA candidate clinical development by year end.

Another business highlight from the quarter was the execution of a new option agreement with our strategic partner Sanofi. The original research [term] [ph] for our strategic alliance expired in June and at that time we chose to enter into an option agreement with Sanofi to negotiate the terms of potentially new relationship.

As such, we received the $2.5 million upfront payments for the exclusivity of these discussions, which are currently ongoing. Specifically, the option agreement gives us the ability to negotiate a potential co-development and commercialization agreement for the miR-121 oncology and fibrosis programs with Sanofi, which we’re very excited about.

Additionally, the Sanofi has the ability to negotiate potentially equal development in license agreement or many unencumbered microRNA in biomarkers. The exclusive option period expired at the end of the year, so we look forward to reporting an update to you on a potential new relationship with Sanofi.

To conclude the business update, we’re pleased to have secured the rights to Alnylam’s proprietary process for manufacturing GalNAc-conjugates. The amendment to the collaboration agreement with our funding companies is very important for Regulus because it will aid us in the continued development of RG-101. It also demonstrates that key information and technology continues to flow immensely throughout the RNA companies. Neil will provide further detail on RG-101 and the importance of the GaINAc conjugate later on the call.

Lastly, we’ll continue make progress in our proprietary biomarkers platform, we recently revised our agreement with Biogen Idec to better reflect our scientific progress and we look forward to providing an update to you on the exciting platform.

To summarize, we had a strong first half of the year and are entering into it existing period of Regulus which we will be focused on scientific and clinic execution. At this time, I would like to turn the call over to Dan, who has Amy mentioned is our Vice President, Finance and Accounting for review of our second quarter 2013 financial results and highlights. Dan?

Dan Chevallard

Thank you, Kleanthis, and good afternoon everyone.

As Kleanthis mentioned, we are pleased with our continued progress to the first half of 2013. We maintained tight control of our operating cost and cash flow to the first half of the year, ending the second quarter with $82.7 million in cash, cash equivalents and short-term investments. Through this most recent period, we have sustained a strong balance sheet and have further strengthened and derisked our financial profile with our recent public offering completed in July through which we raised an additional $45.9 million after underwriter’s discounts, commissions and other offering costs.

Including this public offering, our pro forma cash position as of June 30, 2013 was approximately $129 million. Subsequent to the quarter end, we also received a $2.5 million payment from Sanofi pursuant to the terms of the recently executed option agreement.

Turning now to our financial results. Our net loss for the 3 and 6 months ended June 30, 2013 was $7.3 million and $14.6 million respectively compared to a net loss of $2.6 million and $4.8 million for the same period in 2012. Net loss in the 3 and 6 months ended June 30, 2103 included non-cash charges of $2.7 million and $4.5 million respectively related to the change in value of our convertible promissory note with GSK. These changes – these charges have been and continued to be primarily driven by increases in our stock price at June 30, 2013 compared to March 31, 2013 and December 31, 2012.

We recognized revenue of $4.8 million and $8 million for the 3 and 6 months ended June 30, 2013 respectively compared to $3.3 million and $6.7 million for the same period in 2012.

Revenue during these periods consisted primarily of amortization of upfront payments received from our strategic alliances and collaborations which we recognized over our estimated period of performance.

Revenue in the second quarter of 2013 included $1.1 million related to an acceleration of our estimated period of performance associated with the most recent amendment to the GSK agreement.

Our research and development expenses were $7.7 million and $14.6 million in the 3 and 6 months ended June 30, 2013 respectively compared to $4.9 million and $9.5 million for the same periods in 2012. This increase was primarily attributable to an expansion in our research and development personnel and in IND enabling activities as we moved closer to entering the clinic.

Our general and administrative expenses were $1.7 million and $3.6 million in the 3 and 6 months ended June 30, 2103 respectively compared to $1 million and $1.9 million for the same period in 2012. This increase was primarily driven by incremental cost associated with being a public reporting company.

As Kleanthis mentioned earlier on the call, we are pleased to update our previous year end cash guidance and now anticipate ending 2013 with approximately $110 million in cash excluding the achievements of any further milestones. We believe the strong cash position will extend our runway into 2017 supporting the execution of our research and development objectives during that period.

Let me now turn the call over to Neil for an overview of our pipeline.

Neil Gibson

Thanks Dan and good afternoon everyone.

As Kleanthis highlighted, we made good progress in hitting our goals on the roads to the clinic so far this year and are poised for an upcoming period focused on scientific execution. On the call today, I would like to highlight three of our lead programs and touch upon plans to further expand the pipeline with the proceeds raise from a recent public offering.

First of all, I would like to begin by providing an update on our lead our program RG-101, a GalNAc-conjugated anti-miR targeting miR-122 for the treatment of HCV. We are pleased with the favorable profile of RG-101 to-date, which is a well tolerated compound whose mechanism is (inaudible) and so far no resistance – they’re up to-date when targeting miR-122. Specifically the active oligonucleotide of RG-101 has shown activity against a variety of different HCV genotype as well as some of the no imitations may cause resistance to other regions.

We have shown in rodent models that target gene expression was sustained for longer than 28 days after a single subcutaneous dose of RG-101. The favorable quoted (CMPK) profile will support a favorable dosing regiment for this therapeutic and is well-positioned for reduced treatment of – duration of treatment against the broad range of HCV genotype, which is also important to highlight that we recently gained access from Alnylam to their proprietary process for manufacturing GalNAc conjugate.

A carbohydrate based chemistry approach for asialoglycoprotein receptor-mediated delivery of oligonucleotides to the hepatocytes within liver. MiR-122 is the most abundant microRNA in hepatocytes and the HCV virus co-opts miR-122 for its own replication and function. Utilizing the GalNAc conjugate chemistry has significantly improved the potency of the active oligonucleotide of RG-101 by achieving targeted delivery of the oligonucleotide to the infected hepatocytes.

We believe that GalNAc conjugate delivery is a critical component to the clinical development strategy for RG-101 and we expect this -- explore its potential applicability to additional microRNA programs in the future such as miR-221 for hepatocellular carcinoma which I would describe later.

During the quarter, we made good progress on preparing for clinical development of RG-101, GRP toxicology studies are ongoing and we expect to file with the regulatory authorities and begin clinical studies in the first half of 2014. We are planning a single ascending dose study and healthy volunteers that will be followed by a multiple dose study and healthy volunteers and in parallel the single dose study in HCV patients design to show a human proof of concept.

In the near term, we anticipate reporting additional progress on our RG-101 around the American Association for the study of liver diseases meeting in early November in Washington. We are pleased to be expanding our pipeline with the miR-221 program for the treatment of hepatocellular carcinoma or HCC. Our strategy is to focus on identifying specific oncology and/or often indication targeting microRNAs and the miR-221 program is a particularly good fit for this strategy because we are able to harness our tremendous in-house expertise in oncology.

We have identified potent lead candidates that exhibit miR-221. They are active in both cell-based models and in the tumor models and we have shown the active oligonucleotide formulated and saline connected with the growth of HCC tumor models that over expressed miR-221.

Currently, we continue to work to optimize our ability to deliver these lead molecules. We are using both lipid formulations and also the GalNAc conjugate technology that as worked efficiently so far in for RG-121. Additionally, we are utilizing our biomarker technology to support this program. We are seeking to identify microRNA signatures in the serum of HCC patients that would allow us to focus our clinical development and the patients who over expressed miR-221. We are currently working to optimize our lead candidates and hope to have a more complete direct package for the miR-221 program later this year.

Turning now to our partner program, we continue to be excited about targeting miR-21 for the treatment for renal fibrosis. As a reminder, this program is currently partnered with Sanofi and it’s subject to the option agreement that Kleanthis highlighted earlier on the call.

Within renal fibrosis, we have identified an orphan disease opportunity that fits within our previously outlined strategy. The orphan disease indication in this case is Alport Syndrome, which is a genetic disorder characterized by end-stage renal disease and hearing loss. According to the Alport Syndrome Foundation, the prevalence has been estimated up 1 and 50,000 lives and is caused by genetic mutations to affect the Type IV collagen family of proteins.

The impact of limitation and the collagen gene and disruption to the structure of the glomerular basement membrane increased expression of miR-21 increased fibrosis, loss of renal function which ultimately leads to end-stage renal disease and subsequent death. This is a devastating disease and there is no currently approved therapy on the market.

We are presented preclinical data demonstrating that therapeutic oligonucleotide targeting miR-21 reduces the severity of fibrosis and improves renal function in a rodent model of Alport Syndrome. Because of the severity of the disease, they need for an approved therapy and the results we have seen thus far with the program we believe there is a potential opportunity for break through designation with the FDA. Additional, preclinical experiments are currently ongoing and we are also providing an update on this program in the near future.

Lastly, we continue to harness our expertise and our exploratory efforts with the identification of several attractive microRNA targets namely core oncology indications, which is well-aligned with our current strategy. With the proceeds rate from the recent offering we expect to focus additional resources to all these efforts to expand our microRNA type line with additional proprietary programs.

To summarize, we made steady progress in the advancement of microRNA therapeutic pipeline in the first half of the year. We set very aggressive goals in the upcoming periods will be focused on the execution of both scientific goals. We are preparing for clinical activity with RG-101 and expect to file with regulatory authorities. If we execute on this timeline maybe able to demonstrate human proof of concept by the end of 2014, which we believe will validate our platform and our renovative approach to treating disease.

We also expect to nominate the second clinical development candidate in the second half of 2013, which we complete execution of all of our goals on the Road to the Clinic. Later this year and next, we plan to submit data packages to certain scientific conferences, such as the ASLB and ASCO and we hope to report progress to you at these forums.

With that, I will turn over to Kleanthis for his closing remarks.

Kleanthis Xanthopoulos

Thank you, Neil.

In closing, the first half of 2013 has been very productive period for us and we are very poised for an exciting period ahead of us. We further derisk the financial profile of the company with our recent public offering and we expect to accelerate our R&D goals, expand our therapeutic pipeline and extend our current trend way by growth forward into 2017.

Additionally, our Road to the Clinic goals remain to track and we expect to nominate a second microRNA candidate for clinical development by the end of the year. We are looking to build upon the recent progress and to continue to grow our company. With the breadth of our technology and our belief the microRNA has the potential to transform the (billable) drug discovery. We have a unique opportunity to create significant shareholder value.

So, what does Regulus growth look like in the next 18 to 24 months?

We believe that the current foundation of the company will remain the same. We expect to have a negative well-balanced microRNA therapeutic pipeline with the support of an expanding biomarker platform. A rich intellectual property related to retain our leadership in the field and the support of living strategic partners in a strong financial position. During this time of growth, we expect to have achieved human proof of concept with our RG-101 for HCV. Cut two additional microRNA programs in the clinic and have three additional micro-RNA programs in advance preclinical studies.

We also envision demonstrating the value of our emerging biomarker technology which is designed to support our therapeutic pipeline which will help us further validate our approach to treating diseases.

I am truly excited about our current progress in our past forward and in building a top care bio-pharmaceutical company. Over the next several months we plan to keep you updated on our progress through numerous investors and scientific conferences.

We are now ready to take your questions, operator.

Question-and-Answer Session

Operator

(Operator instructions) The first question comes from Bill Tanner from Lazard Capital.

Bill Tanner - Lazard Capital

Thanks for taking the questions, congratulations on all the progress. Neil, had a couple of questions for you, number one is, was going to ask on the GalNAc delivery mechanism, what other anti-miRs you saw that it could be applied to in, then you did mention miR-21. But I guess I am trying to understand a little bit better how uniformly applicable this might be to anti-miRs that you might want to target the liver with. And what else out there do you see that could be potential candidates that are not currently being looked at by Regulus?

Neil Gibson

So in addition to the -- I was just going to say Bill in addition to the miR-122 program we have been focusing on trying to develop a better understanding on the level of asialoglycoprotein receptor expression in HCC and this would be relevant for a number of our oncology programs including 221 and 21. So, the level of expression of asialoglycoprotein in HCC patients is about 70% all of the level of expression in the normal hepatocytes within the liver.

So we think that it’s an appropriate level of expression to be able to enrich delivery to the HCC tumor cells within HCC and we’re currently evaluating that opportunity within both 221 and 21 program.

Kleanthis Xanthopoulos

Okay. Let me add a few comments because this is a very good question.

The way we would like you to think about Regulus and delivery of anti-miRs is threefold. We have efforts and a good understanding about how to deliver anti-miRs depending on the indication and the target that we’re looking for.

And basically, three major categories to think about, one is receptor mediated, so GalNAc is an example of that, and because GalNAc is restricted to hepatocytes we’re going to be thinking a lot about microRNAs in diseases that are associated with hepatocytes and we’re going to use GalNAc conjugates to address those.

But receptor mediated also has additional benefits, we for instance investigated other ligands that can use and be used in the same kind of way but targeting different organs. So, that’s one category GalNAc is going to be used for hepatocytes and liver diseases.

Another category simply following the experience that Isis has and formulate the anti-miRs naked. And we know that and we can go and look a half a dozen organs very effectively the most importantly high levels of delivery in kidney.

So, in our renal fibrosis program there is no reason really to conjugate the anti-miR, we’re going deliver it naked, and we know we’re going to go into the appropriate cell type in kidney.

And finally, there is another category which is nanoparticles that includes lipids and there again it would depend on the indication and the cell types. So, Regulus is very fortunate to have the ability to pick and choose the delivery technology based on the indications and the specific cell type that we’re targeting.

Bill Tanner - Lazard Capital

Okay. That’s helpful. That makes sense. And Neil, just had one on, you have some conversations from time to time, people would point out in the literature the 122 knockout animals and how they have some aberrant phenotype seems to me kind of an extreme phenotype – or genotype I guess in terms of completely knocking it out, but just wondering what your thoughts are then on now to put it relatively or put it in a relative context?

Neil Gibson

Yes, thanks Bill. I think there is a couple of other points that are important to make in addition to that knock which as you stated as complete knockdown of miR-122 for the life of the animal. So, Phil Zamore has been working with his, what he calls [cut decoys] [ph] that is he showing in the mouse liver when you knock out 122 first six months, there is no phenotype. When you basically pharmacologically inhibit 122 for a sustained period of time you actually improved liver steatosis and we didn’t see any evidence of HCC. And we’ve also know from the clinical data that’s Santarus have generated that there have been no untoward adverse events reported yet along those lines.

And finally, we’ve seen in our non-GLP, and we will look and evaluate within our GLP tox but we’ve seen a very well-tolerated profile for the molecule so far.

Kleanthis Xanthopoulos

And remember, Bill, we plan to have this as a monthly administered drug, we believe about [40 sections] [ph] and you’re done in a very short period of time.

Bill Tanner - Lazard Capital

Great, okay. Thanks very much.

Operator

The next question comes from Jim Birchenough from BMO Capital.

Chuck Whitesell - BMO Capital

Hi, it’s Chuck Whitesell for Jim. You spoke about the agreement with Sanofi, for miR-21 and that was extended till December, is it reasonable to assume that the agreement would be extended beyond December and are there discussions are going or planned?

Kleanthis Xanthopoulos

That’s a reasonable assumption. But, let me provide a little more color, the 21 in both oncology and fibrosis is a core program around which we build the relationship we had with Sanofi. So, that’s going to continue one way or another. We and Sanofi have enjoyed a very good relationship. We feel that -- and Sanofi agrees with us that we can provide a lot of -- [in terms of] [ph] guidance, drive the program to human proof of concept into the clinic.

So, we are taking time to renegotiate some of the aspect of that agreement to reflect our efforts clinically which were not anticipated in the original agreement to refresh your memory. Our original agreement was stating that we’re going to file an IND and then Sanofi takes over. We want to have a little more say in how the program develops given some of our both expertise and flexibility.

Secondly, of course, it gives Sanofi the time to look into other partner programs and build a relationship that is bigger in nature than the one existed. So, we will see where we stand at the end of the option period which is in December. But I think it’s a best case scenario for your modeling and thoughts would be that 21 fibrosis and oncology will continue between Sanofi and Regulus with the possibility of expanding into additional microRNA targets.

Chuck Whitesell - BMO Capital

Okay, great. I had one other question, if I’m allowed. And that was regarding miR-10b, could you tell us what the status is of validation of the miR-10b biomarker assay and could you update the timing for product nomination?

Kleanthis Xanthopoulos

I’ll turn it to Neil. I stated normally that as we reported previously in our discussions, we did have some technical problems with the preclinical models for 10b which are now resolved. And I’ll turn it over to Neil to give you an updated timeline on that particular program. Neil?

Neil Gibson

Yes, thanks Kleanthis. So, within the 10b program in addition to the extensive work we’re doing with Samsung, we’ve also entered into collaboration with Anna Krichevsky at Harvard so that we can get multiple different evaluations of the anti-tumor efficacy of 10b in a variety of different glioblastoma models. These are all ongoing and we look forward to evaluating that dataset in the fourth quarter this year with the goal to finalizing where we stand, with our preclinical candidate type of assessment.

Chuck Whitesell - BMO Capital

Okay, great. Thank you.

Operator

The next question comes from Simos Simeonidis from Cowen & Company.

Simos Simeonidis - Cowen & Company

Hi, guys, thank you for taking the question. Can you walk us through your thought process about deciding about your second IND that the kind of -- for the second IND, what are the things you’re going to look at and I don’t know, if can you tell us which way you are leaning but what are some of the keys things you’re going to look at when you decide which one to go in with next?

Kleanthis Xanthopoulos

Simos, as you know, we have a big problem which is a good problem to have too many good programs moving forward. So, there are similar forces in the race, partially it’s driven by science and that the preclinical data as they come. But because we stated before there is at least two potential three programs that competes for that second nomination, we discussed they have a 21, fibrosis oncology and 21 in hepatocellular carcinoma. We think most likely one of this three problems would be the second candidate.

Simos Simeonidis - Cowen & Company

Okay. And then the, recently amended agreement for the GalNAc technology, what are the terms for -- in terms of what do you owe to Alnylam and Isis?

Kleanthis Xanthopoulos

The beauty Simos is that we owe nothing other than what was contemplated in the original agreement. In the past, I have made comments in that, our funding agreement between Isis, Regulus and Alnylam is dynamic. And therefore new technology is developed by the Isis or Alnylam that have utility in our hands to microRNA therapeutics become automatically part of the technology basis that we have without any additional finance reimplications and vice versa as we developed technologies potential Isis and Alnylam have utility for the respective fields they can, they can do that. It’s a beautiful demonstration of that dynamic and there is healthy relationship between the three companies.

Simos Simeonidis - Cowen & Company

It’s the continuation of that parental gift to you guys?

Kleanthis Xanthopoulos

That’s correct.

Simos Simeonidis - Cowen & Company

Finally, in terms of what to expect in terms of news flow from the RG-101 trials for next year, Neil talked about two of them, roughly when do we expect them to start and roughly once so we see data if you can be that granular this early on?

Kleanthis Xanthopoulos

Neil?

Neil Gibson

Yes, as we mentioned, Simos, in our earlier statements, we’re anticipating filing all the appropriate regulatory documents to initiate the single ascending dose study in healthy volunteers in the first quarter this year. And we anticipate in the way that this development plan has to be in structure where once you get up like say third to fourth closing cohort in the single dose study that would allow us to start with the multiple ascending dose study and a single dose study in HCV patients with the multiple sending dose study and healthy volunteers, both of those studies would be able to go on a parallel allowing us to be able to potentially show some proof of concept in a single dose of HCV started before the end of 2014.

Simos Simeonidis - Cowen & Company

Okay, great. Congrats on the progress.

Operator

Okay. (Operator Instructions) The next question comes from Alan Carr from Needham & Company.

Alan Carr - Needham & Company

Hi, thanks for taking my questions. One of you could comment a bit more about everything standard discussions with the Biogen and what’s your I guess your goals are in those discussions? And then I guess in a bigger sense, how you’re thinking strategically about keeping programs in-house versus part ring, if you’re contemplating, I guess licensing more targets to Sanofi and that renegotiation much be doing the same thing with Biogen? Thanks.

Kleanthis Xanthopoulos

Alan, good and big questions. So, let me take it, part into two separate answers, one focusing on Biogen and biomarkers because it is distinctively in the biomarker technology and not therapeutically related. So, we and Biogen Idec (inaudible) recognize that we’ve developed very unique technology where we can detect microRNA signatures in blood as little as 50 micron liters of blood are sufficient to give us a signature of certain microRNA that can predict shelved versus deceased. And this is now base on clinical samples about 400 clinical samples that we received from Biogen Idec. That the results are very, very exciting because we extend the platform from simply stratifying over expressing certain microRNA disease to something more potentially useful in terms of guiding a therapeutic which is the ultimately goal.

So, Biogen Idec is now thinking of expanding that relationship with many more samples and potentially additionally therapeutic indications. The beauty of this is that he has allowed to industrialize our platform due to -- demonstrate clinical utility and we retain all the rights to the technology including potentially this signature becomes commercialized. That would be 100% owned by Regulus. And that has of course will help us stratify our future populations of patients depending on expression of microRNA.

So, this is a very exciting deal that additional for partners and other people of expressing (inaudible).

As we turn to Sanofi that of course both was exclusively on therapeutics although we simply – they have also expressed some interest in biomarkers and that’s part of the discussion we are having. Our desire rather than giving a number of targets to Sanofi is to develop a core development and core commercialization strategy with them, if we agree in such a frame work.

So, we think, we are looking to change the relationship to be much more of a partner all the way to potentially commercialization as opposed to delivering good compounds that they develop and then receiving milestones and orders.

Alan Carr - Needham & Company

So, you’re looking to expand I guess the number of targets but at the same time, have more of a role in each of those through development and the commercialization with Sanofi?

Kleanthis Xanthopoulos

Correct. I believe as it comes to North America or United States commercialization lights.

Alan Carr - Needham & Company

Okay, great. Thanks very much.

Kleanthis Xanthopoulos

Thank you, Alan.

Operator

At this time, I’m showing no further question. I would now like to turn the call back over to Kleanthis for closing remarks.

Kleanthis Xanthopoulos

Thank you all for joining us on the call this afternoon. We are very pleased with our recent accomplishments and really look forward to achieving our goals from the Road to the Clinic. We look forward to talking to you again in the near future. Thank you all.

Operator

Ladies and gentlemen, that concludes today’s conference call. Thank you for your participation. You may now disconnect. Good bye.

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