Q2 2015 Earnings Call Transcript

Published: 10 Aug 2015

[Operator:]

Good day everyone and welcome to the Radius Health Second Quarter 2015 Earnings Conference Call. Today call is being recorded. At this time, I would like to turn the conference over to Barbara Ryan. Please go ahead. Barbara Ryan Thank you, Uginia, welcome and thank you those of you joining us on the line and on the webcast this morning for a review of Radius Health second quarter 2015 financial and operating results. I am Barbara Ryan, Radius Health’s Investor Relations Officer. And with me this morning to discuss the results and update you on our progress are Robert Ward, President and Chief Executive Officer; and Nick Harvey, our Chief Financial Officer. Before we begin, I would like to remind you that any statements made during this call that are not historical are considered to be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these statements as a result of various important factors, including those discussed in the risk factors section in our most recent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission and our other reports filed with the SEC. Any forward-looking statements represent our views as of today August 06, 2015 only. A replay of this call will be available on the company’s website www.radiuspharm.com following this call. You can find the dial-in information for the replay in today’s press release as well as on the company’s website. I will now turn the call over to Robert Ward, President and Chief Executive Officer of Radius Health.

[Robert Ward:]

Thank you, Barbara and thank you to everyone who has joined us on our conference call and audio webcast this morning. The second quarter of 2015 included several key accomplishments for Radius Health. We completed our first full year as a public company. We announced the results for the ACTIVExtend trial, shared important new data on RAD1901 and recently completed a follow on offering that provides a solid financial foundation to prepare for evolution from a development stage to a commercial by the technology company. On June 5 of this year we celebrated the one year anniversary of Radius Health and issue public offering and we are proud to be the number one performing IPO over the 12-month period in total shareholder return. We believe that this positive performance reflects the substantial progress we have made in our pipeline and in building our company. Our recent follow on offering has expanded our investor base and we would like to thank our shareholders for their support that has enabled us to advance the Radius Health portfolio, as most of you know also in June of this year we released additional data from our ACTIVE trial as well as the top line data from the first six months of ACTIVExtend. The ACTIVExtend trial is the 24 month open label extension in which patients from the abaloparatide and placebo treated groups of the ACTIVE trial were placed on alendronate therapy for osteoporosis management. The ACTIVExtend six month study results exceeded our expectations. The group previously treated with abaloparatide had not additional new vertebral fractures during the first six months of the ACTIVExtend trial. Please remember, that from the start of the ACTIVE study, the abaloparatide treated patient showed a statistically significant 87% reduction in new vertebral fractures, the highest reduction ever reported in an osteoporosis trial and highly significant reductions in non vertebral fractures, clinical fractures and major osteoporotic fractures as compared to placebo. We believe that these results support our view that abaloparatide has the potential to represent a new treatment paradigm for patients at high risk of an osteoporotic fracture. With these key Phase 3 trials now completed, we are focused on submitting the full 25 month results for regulator review with the EMEA and FDA by year end. As we shared previously, our transdermal of abaloparatide optimization activities have progressed throughout the quarter and we expect to initiate the clinical evaluation of the optimized transdermal patch with the goal of achieving comparability to abaloparatide subcu later this year. We continue to add key talent to Radius to both support our registrational submissions as well as building our commercial capabilities. Just last week Dr. Lorraine Fitzpatrick, a globally recognized expert in the field of osteoporosis and oncology joined Radius as our Chief Medical officer GlaxoSmithKline At GSK the led the global development group for Denosumab. During the quarter, we were very pleased to have four abstracts for abaloparatide accepted for presentation at the American Society of Bone and Mineral Research this upcoming October. Dr. Felicia Cosman, a professor of clinical medicine in Columbia University in New York will provide plenary oral presentation of the combined Phase 2 results from both the ACTIVE and ACTIVExtend trials. Also Dr. Lorraine Fitzpatrick from Radius Health will make an oral presentation of the effects of abaloparatide on major osteoporotic fractures. Two additional posters will be presented. The results from the abaloparatide responder analysis and to those who are following our progress with transdermal will have an interim result on the transdermal development program. Turning attention now to RAD1901, this is our selective estrogen receptor degraders or SERD which we are evaluating in post menopausal women with advanced estrogen receptor positive and HER2-negative metastatic breast cancer. On July 15, we announced early but very promising preclinical data showing that RAD1901 in combination with Pfizer’s palbociclib, a CDK4/6 inhibitor, or with Novartis' Afinitor, an mTOR inhibitor, was effective in shrinking both resistant or wild type patient dry tumors. In the patient-derived xenograft breast cancer models the combinations with RAD1901 showed greater anti tumor activity than as shown with any of the three agents alone. This combination used data will be very important to us as we evaluate the study design for continued development of RAD1901 in metastatic breast cancer. We are continuing to screen and enroll patients in our Phase 1 metastatic breast cancer dose escalation study. Our objective with this study is to identify the most promising dose of RAD1901 to take forward into Phase 2 development. In the quarter, we submitted abstracts for the San Antonio Breast Cancer Symposium in December and will update you on these presentations as information becomes available from the symposium organizers over the summer or early fall. We have also expanded our capabilities on oncology. On July 20 Dr. Debasish Roychowdhury joined our board of directors Previous Debasish was Seragon’s acting chief medical Officer and web development activities for their SERD program prior to the company’s acquisition by Roche. Also during the quarter we formed an oncology clinical advisory board to support us as we plan the future development of RAD1901. As we previously reported low dose RAD1901 demonstrates it clinically significant reductions of a frequency and severity of moderate and severe hot flashes in a Phase 2 proof-of-concept study. By yearend of 2015, we intend to commence a Phase 2b clinical trial from vasomotor symptoms, recall this is an area of high unmet medical need with a significant interest in the potential of non hormonal therapeutic option. Now, I would like to turn the call over to Nick Harvey, our Chief Financial Officer who will discuss our second quarter results and provide an update on our balance sheet.

[Nick Harvey:]

Thank you, Paul. Cash, cash approval and marketable securities balance as of June 30, 2015 was 224 million subsequent to the end of the quarter on July 28, Radius raised approximately 323.8 million of net proceeds in a follow-up public offering of their common stock. On August 4, 2015 repaid all amount owned under our Loan and Security Agreement with Solar Capital Oxford Finance. After consideration of the relevant fees required under the loan agreement, the total payment amounted to approximately $26.5 million. This prepayment results in significant savings to Radius Health over the expected cost of the full life of the loan. We are updating our guidance on our cash burn and expect that our cash, cash equivalents and marketable securities as of June 30, 2015 together with the proceeds of the July offering will carry us into 2018 and are sufficient to fund our development plans, U.S. promotional scale up and other operational activities prior to the consideration of revenue from the potential future sales of any of our investigational products. I will turn the call back to Bob.

[Robert Ward:]

Thank you, Nick. Before we open the lines for questions I would like to summarize our upcoming milestones for the remainder of the year. Having now both completed and reported the positive top line results for the Phase 3 ACTIVE trial of a six month ACTIVExtend trial, we are on track to submit an MAA in the EU and NDA to the FDA for the investigational drug of alpere [ph] type subcu by the end of this year. We are continuing our partnering discussions and are on track to have entered into a collaboration to enable global commercialization by the time of launch. We plan to initiate clinical evaluation of the optimized abaloparatide transdermal patch by yearend. For RAD1901, we will share additional information with you later this year on our ongoing Phase 1 trial in metastatic breast cancer and are initiating an additional Phase 1 clinical trial in the European Union as we move through the third and four quarter. We expect to begin a Phase 2 trial for low dose RAD1901 for vasomotor symptoms by yearend as well. Next week, we will be presenting at the Canaccord Genuity growth conference in Boston on August 12. As I said earlier, we are extremely excited to have multiple presentations at ASP this year including Dr. Cosman’s Plenary Presentation of the 25-month ACTIVE and ACTIVExtend trial data. So thank you for your continued interest in Radius, we felt that the quarter was successful and exciting one and we are certainly happy now to entertain your questions and operator, before we open up the call, I would like now to ask our colleagues to join for the Q&A period, Greg Williams, our Chief Development Officer is online, Gary Hattersley, our Chief Scientific Officer, Dinesh Purandare, who leads our efforts in oncology, as well as Brent Hatzis-Schoch, our General Counsel has joined us for the call today. So operator, I think we are now prepared to take questions.

[Operator:]

We will now begin the question-and-answer session. [Operator Instructions] The first question is from Eun Yang with Bank of America Merrill Lynch, please go ahead.

[Eun Yang:]

Hi, good morning. Thanks for taking my questions. So first of all I know the exploratory analysis you conducted against Othello [ph] showed a significant reduction in major OTO product fractures, I assume that’s not pre specified and do you think it’s likely to be written in a label or not when FDA approve that type. And then secondly on Radius 1901, obviously it’s a bit too early but do you guys have any plans to think which combination regimen you would rather test in the Phase 2 clinical trial for that indication in metastatic breast cancer? Thank you.

[Robert Ward:]

Absolutely, terrific questions. As we think about the regulatory process we have not yet submitted our NDA or our MAA, and so the questions about labeling, should we come up during the review cycle, so we‘ve not yet engaged with the agency on labeling around their type. When we look at the European labeling for Prolia or Denosumab, you will see the European labeling includes a detailed description of different categories of fractures including of course major osteoporotic fractures. The U.S. labeling traditionally has not been as detailed as the European labeling approach, so we believe that as we go through the review process will be out of five greater details for you as we learn more from interaction with the agency. With regards to combinations for RAD1901, we are very excited about the data which shows the preclinical models where in both tumor types that were resistant to previous drug exposure as well as novel wild type tumors that the combination showed such unexpected additive or synteretic effects. Dinesh, could you share with us as we think about the development for RAD1901, how would we think about combinations, why the combination matter for RAD1901?

[Dinesh Purandare:]

So in the field of breast cancer, it is extremely crucial to look at tumor that have either failed on tamoxifen or resistant to tamoxifen as well as tumors that are resistant or progressed on [indiscernible], the recently announced data shows that the synergistic combination with RAD1901 with either palbociclib or mTOR looks extremely promising, so this opens the door for us to evaluate variety of these combinations as well as looking at other types of areas like mutant population, so we would be looking at multiple ways to move forward but extremely excited about the data that allows us to move in this direction very quickly.

[Robert Ward:]

Eun, I did not answer one other important element about why data around major osteo product fractures matters. Okay, as you mentioned, we showed that compared to teriparatide inner trial, there was a substantial reduction in major osteoporotic fractures for abaloparatide that was statistically significantly favorable as compared to the teriparatide group. From a payer perspective in Europe, where often referenced based pricing is so important, one of the considerations is whether a new agent shows equivalent therapeutic benefits, improvements in therapeutic benefits or reduced therapeutic benefits, for those that are equivalent or reduced realistically reference based pricing caps via pricing opportunity. For agents that demonstrate a superior activity that’s when referenced based pricing plays less of a role and the setting of the prices it comes to market, so we believe that this difference on major osteoporotic fracture or whether it’s a difference on wrist fractures of difference in VMD, difference in hypocalcemia, there is two different considerations, one is through the regulatory process, how that time of labeling, the second is for a payer as they look at the trial which is very unusual having the market leader drug in the Phase 3 program in a trial that’s larger for the market leading drug than the original approval trial and in that trial a payer can see that the number needed to treat is substantially reduced with abaloparatide as compared to the teriparatide arm and so from an economic perspective that says for the healthcare dollar, a larger number of patients respond to abaloparatide. So we think that there is really two different conversations that will be important as we go through the upcoming years, the regulator conversation but also as payers look to ask the question, what’s the health economic value, we think the data is very important as well.

[Eun Yang:]

Thanks, Bob for that detailed answer. If you don’t mind just one follow-up, can you update us where your CMC work is being down here and what’s the status for CMC for the FDA – NDA submission? I will hop back to the queue. Thanks.

[Robert Ward:]

Sure. We have a global supply chain and Dr. William, do you want to remind us how the supply chain is organized and where we are in terms of track for both MAA and NDA submission?

[Greg Williams:]

Sure, thank you, Bob. So as documented in our various filings we are working with Lonza to produce our drug substance, we are working with Feder [ph] to produce drug product in the form of filled cartridges and also in the form of disposable pens, the pens’ player sits on that, these are all well known manufacturers who have been through order through the agency, we’ve completed the validation of our drug product manufacture, our API manufacture, we are in nearly very good shape as we move forward towards our MAA and NDA applications.

[Robert Ward:]

And then additionally for transdermal patch of course our key partnership is with 3M. A - Barbara Ryan Uginia, can you take the next caller?

[Operator:]

Of course, the next question is from Jeff Chen with Cowen & Co. Please go ahead.

[Jeff Chen:]

Hi, good morning. Thank you for taking my questions. So, first one for Bob, maybe could you discuss in terms of, are there any chances of expedited review process in the U.S. or EU for abaloparatide injectable?

[Robert Ward:]

You know, Jeff, that’s a very good question because when you think about the programs that exist, there is multiple path to achieve either rolling submission or accelerated review. In our base case, we build the business model around the standard review period, as we look at programs that are suitable for abaloparatide that we believe the regulatory agency will have tractions on this, but we apply to be considered for those programs, so recently we had mentioned that we would apply for the breakthrough designation. Now in the field of osteoporosis there has never been a drug that’s been given a breakthrough designation but we thought it was because of the emerging clinical profile that abaloparatide would be a drug that will be likely to meet those standard, so originally at the end of Phase 2 with only be BMD data reapplied and the HC indicated that fracture data that’s the basis of an evaluation, and so we shared data around the primary and secondary endpoint from the ACTIVE trial, the agency said that on the review of the primary endpoint, they were looking for drugs with non-overlapping confidence intervals as a part of their calculation, so based on the primary endpoint, they wrote back that they were not blowing to grant a breakthrough designation. Now, there are other agency programs that we believe, we are eligible for and as we go through the regulatory process, you know we’ll engage with the regulators to apply for each of the possibilities for that. Now, if we do achieve a successful either blowing submission or earlier priority review, of we will let it run up.

[Jeff Chen:]

Thank you. That’s very helpful. Maybe, if you can just give us some insight on the patch development pathway, so you will start a clinical evaluation, what would come after that trial?

[Robert Ward:]

Yes Jeff, it’s a terrific question. We think patch technology allows physicians who have not previously used anabolic therapies because they are injectable drugs to consider how to add anabolic therapy into their practice, for other physicians who today use injectable anabolics, we believe it’s the clinical data that really is the basis of decision making, remember in our Phase 3 trial, we have shown that the physiologic response to abaloparatide is different than the response to other peptides, so as we think about competition in the space, it’s about both the peptide as well as the technology platform but Dr. Hattersley, could you remind us of what’s been accomplished today, where we are today and what’s next with the Radius transdermal program?

[Gary Hattersley:]

So, you know back in 2014, we previously reported the results from the six months Phase 2b and d study in which approximately 250 women with personal problem with osteoporosis received administration of our transdermal patch, we are very encouraged to see dose dependent increases in BMD in both the spine, hip and the femoral neck, our current plan is to build on that extensive clinical experience with the optimization of our current patch.

[Robert Ward:]

So Hattersley, we decided based on the very promising results to optimize the patch, we didn’t take the patch forward because there were differences in BMD, differences in PK and differences in biomarkers, why have we gone down the optimization path, what are the regulatory implications of having a patch that doesn’t match subcu?

[Gary Hattersley:]

Great question. So, based upon dose parameters not matching, it would raise questions about quality and therefore could potentially require a fracture study to be conducted, our current strategy is to optimize the transdermal patch so that we can achieve pharmacokinetic equivalence to the subcu injection and therefore allow more simple bridging strategy to subcu, so our current efforts are focused on optimizing the transdermal patch, so we can achieve bioequivalents to subcu.

[Robert Ward:]

So Jeff, our goals is that for a physician who would select injectable abaloparatide or for a physician who might select transdermal abaloparatide, we would like to be in a position where they have confidence that the clinical response is the same regardless of louder administration. We believe there is some patients for whom injectable therapies are actually quiet acceptable, if you look at the market today, the market leading product in osteoporosis as we speak are injectables, if we look to the management of rheumatoid arthritis, the market leading products are injectables. We do think patch with stent the market but we think it’s a complementary product to an injectable, does that answer your question Jeff?

[Jeff Chen:]

Yes. And obviously the option between the patch and the injectables definitely a nice advantage, just in terms of, I know that your competitors have to carry out Phase 3 trial to compare their products, is that also the pathway for the patch here?

[Robert Ward:]

Well remember, when we conducted our fracture trial that was a major undertaking sub three years, 30 sites across 10 countries allow in comparisons of our subcutaneous product to both placebo and the ACTIVE competitor arm of teriparatide, if we were taking forward a patch that required a fracture trial, it would be an ask to repeat that size of undertaking with the patch, with a patch that is comparable to the subcu, we believe that there is other regulator paths that will be much more applicable and weltrombini [ph] may not require a fracture trial. Dr. Williams, could you just remind us why does bioequivalence open a different regulatory path?

[Greg Williams:]

Sure Bob, so from the perspective of bioequivalence, if we have a clinical pharmacokinetics, it would be expected that we would have comparable biomarkers, we would have comparable effects on bone and we would be in essence validating the fracture reduction associated with the transdermal product relative to such year for which we have already run an extensive fracture program, so the work that we are doing in optimizing the transdermal really fits very well with this alternative pathway.

[Robert Ward:]

So Jeff, just to remind you of where we are today, there has been substantial progress the optimization work, we will be back into humans to replicate the data we generated in a primate model and then we move forward to more formal trial. At the end of that program, we will be engaging with the agency to discuss with them directly all of the questions that you have asked here on the phone today, so as always the case until we have a regulator action, we will seek additional feed back from the FDA but we shared with you today what is our understanding of what the landscapes are doing.

[Jeff Chen:]

That’s super helpful. Thanks very much. If I may just one more on RAD1901, in terms of the update San Antonio, can you just give us little additional color on how many patients might we see data from as well as what type of data, might we people will get a first look at it the drugs? Thanks.

[Robert Ward:]

Remember, right after Hasco [ph], the San Antonio abstracts were submitted and the symposia has not yet made the determinations on what’s been accepted, so as soon as we know what’s accepted we will be back with greater information, Dinesh, when you think about progress in the Phase 1, our objective is to identify a dose to take into Phase 2.

[Dinesh Purandare:]

Yes.

[Robert Ward:]

If the drug is tolerable, so you moves all of the cohorts then it takes longer to finish the Phase 1 then if the drug has toxicity and you immediately hit the ceiling, could you just remind us into Phase 1 study design, how does the three by three design work, I know it started at 200, so how is the trial potentially?

[Dinesh Purandare:]

So, thank you Bob. So the three by three design that we have for RAD1901 in oncology starts at a dose of 200, it goes to 400, 600, 800 and 1000 and we enroll certain cohort of patient, three patients in each cohort and they have to stay on treatment for approximately 28 days to a month and that’s how we will be making progress and enrolling continue to enroll patients in variety of cohort, so as per Bob’s point earlier, depending on what cohorts we enroll and that trial is enrolling well, we should be coming out with a data pretty soon.

[Robert Ward:]

So we have completed a 52 healthy volunteer maximum tolerated dose study that went from 200 to a 1000 mg, we anticipate that from some study is completed, that we will have a data in September, that time we will make the tolerability profile available, remember our goal to identify the Phase 1 dose, anticipate that the drug is fully tolerated, and we run through all of the cohorts, that’s likely to be a early 2016 event if there were toxicity that’s limited then there would be earlier identification, based on the healthy volunteer study between 200 and a 1000 odd reps, we did not have a formal dose limiting toxicity.

[Jeff Chen:]

Thanks again for taking my questions.

[Robert Ward:]

Thank you.

[Operator:]

Our next question is from Eun Yang with Jefferies. Please go ahead.

[Unidentified Analyst:]

Hi this is [indiscernible] for Eun. Thank you for taking the question. So following that ACTIVExtend 25 month data and exploratory analysis ACTIVE teriparatide, do you think you will likely be able to price some premium to foresee?

[Robert Ward:]

Well when you think about the unmet medical need in osteoporosis, in the U.S. alone it’s estimated that each year there are two million patients that have an osteoporotic fracture at any site. We estimate that in the current year 50,000 U.S. based individuals will be treated with Forteo or less, so if you sit in the current market the unmet medical need is substantially greater than the number of patients that are using anabolic therapy today, so when you are picking a price, one of the questions that we want to make sure we think very powerfully about is the health economic value for abaloparatide. If we are payers and we are making a decision to invest our healthcare in dollar, picking a product that offers the greater benefit for the highest unmet medical need patients is really what the payers are being asked to do. So when we pick a price that allows the payer to say, we understand the health economic value of abaloparatide, we think that abaloparatide is health economically justified to treat as much larger number of patients with high unmet medical need that will be an important consideration in our pricing, we do think that based on traditional models as we look at comparisons, there is reason we believe that the improvements in clinical efficacy would suggest that premium pricing could be a path to go down on but remember with such a large number of patients today who are not receiving therapy, we will want to make sure that access is kept in mind so that patients who are in need of therapy have the ability to access what we hope to be an important contribution in the field.

[Unidentified Analyst:]

Great, thank you so much. That makes sense. And then one more on abaloparatidem, do you think the majority of sales will likely come from anabolic market expansion or market share gain from Forteo?.

[Robert Ward:]

That’s a terrific question. You know when we think of the market since it’s a two year treatment period, typically the patients’ turnover so to speak over a short period of time. Forteo launched over a decade ago, so if you said the physicians who today routinely use Forteo made their decision to adopt Forteo sometime ago and so that market is relatively stable but currently represents a collection of physicians who understand anabolic therapy and we would anticipate would be the early adopters. We talked a moment ago about incident fractures many of these patients are presented at hospitals were managed by orthopedic surgeons or managed by Fracture Liaison Services. Today, we estimate that represents about 4% of the use of teriparatide, we think that there is a substantial unmet medical need in that area and so as we would go forward, we think that success with abaloparatide is based on two things for physicians who use anabolic therapy today ensuring that they understand the reasons why abaloparatide may be effective choice for their patients and for physicians who are managing osteoporotic fracture patients but have not adopted anabolic therapy, we think for those physicians it’s a different decision path, so we really see it as two markets that will evolve, the market that represents the “as is use in anabolic therapy and the much larger opportunity for addressing the needs of patients who today are not receiving therapy.

[Unidentified Analyst:]

Okay, great. And then just one more on RAD1901 acreage it looks like intolerability at 1901 could potentially be better than versus ARN-810 in terms of diarrhea, do you expect there will also be some differentiation on efficacy?

[Robert Ward:]

That’s a terrific question. When we think of the preclinical data, such as the data we just showed, we believe there is an emerging profile that suggest RAD1901 looks quite different than other agents that individuals have been studying previously and you are right tolerability is very important part particularly as we think about combination but there is question of tumor regression versus tumor stasis, what is the profile that would emerge from RAD1901, now pre-clinically last week we have done a number of preclinical studies comparing RAD1901 to tamoxifen and fulvestrant, could you walk us through how do the agents compare as we look at….

[Dinesh Purandare:]

Sure, so in variety of preclinical studies that we have done RAD1901 compares extremely well versus tamoxifen and fulvestrant in dybraxing [ph] the tumors, in particular I think there is an emerging area of the resistant tumors to fulvestrant as well and as you would expect fulvestrant doesn’t do well over there and whereas RAD1901 shows marked tumor inhibition.

[Robert Ward:]

So as we think about tumor resistance these are the estrogen sensitive receptor agents or Esr1 mutation. So the receptor itself actually changes the immunoassay so the tamoxifen or raloxifene can longer bond over that block. Gary I know that we have done some additional modeling but do you have reason or data that suggest that this emerging resistant receptors will or will no interact with a RAD1901.

[Gary Hattersley:]

Yes, absolutely. I think the preclinical data is emerging around SU receptor mutations, so far it is very encouraging, particularly in a breast cancer models that are resistant to [indiscernible] and tamoxifen, we have seen very good efficacy with 1901, so I think that’s very, very encouraging.

[Unidentified Analyst:]

Thank you.

[Operator:]

The next question is from Mara Goldstein of Cantor Fitzgerald. Please go ahead.

[Mara Goldstein:]

Thanks very much for taking the question. Just go back to the expectation around possible beta tenants on your breast cancer symposium, maybe you can just remind us, ask sort of the number of patients and what we saw, not understanding that the San Antonio abstracts would do and what might have been submitted at that time relative to when should you present data at San Antonio five months later, what we could expect in terms of number of cohorts and things like that?

[Robert Ward:]

Mara, remember at ASCO we had submitted a poster that was in the clinical design section that really talked about the design of the Phase 1 study, we have not give in a practice of updating enrollment, actually in terms of high degree of competition in this space, we have expanded actually the number of site enrolling patients in the trial and we are quite comfortable that we are on track for our key objective which is to identify the dose going forward, we will find out from San Antonio the abstracts that have been accepted as we move through August and September and as soon as we know we will be back to share that information with the field.

[Mara Goldstein:]

Okay. And then just as with respect to the optimization of the transdermal, what you actually would be looking for an interim result there?

[Robert Ward:]

Sure. Dr. Hattersley, you want to talk about what is optimization and what are the access studies we do in primates?

[Gary Hattersley:]

Yes, absolutely. So, as what was described a little bit early on, our strategy is to reach the patch two subcu based upon a bioequivalent so we recently reported results from a pharmacokinetics studies and we have optimized the patch that can achieve a profile that is comparable to subcu injection and so our next clinical study will be focused on replicating those primate study results in which we take the optimized patch back into the clinic and compare it to the subcu to assess whether comparability to subcu is able to be achieved.

[Robert Ward:]

And an ASP method here we do have a post that has been accepted with the transdermal program, that we are focusing that on.

[Mara Goldstein:]

Okay. And just in terms of just scope of that in terms of what numbers we should be looking for just to…

[Robert Ward:]

You are thinking Mara in terms of when we do the replicative study in humans family, does it take….

[Mara Goldstein:]

Yes, exactly. Thanks Bob.

[Robert Ward:]

Well, drug activity this year remember once we identify the patch they have to be manufactured, so we are in the process now of preparing those patches and an important part is to make sure that we make enough patches so that it’s, when replicative studies is all previable, we are prepared to move forward with additional clinical studies, so the real time related event for us is very basic making the clinical supply, the replitive study itself is relatively quick once started and then after that we will do a more formal study where one element would be to do a formal bioequivalent arm but we anticipate at this time that we would also do a BMD and or patient recorded outcome studies along with that, so the time is in a transdermal patch physicians and patients would have an opportunity to share their experiences with the product prior to its submission for regulatory review.

[Mara Goldstein:]

Okay. And if I can just sort of a broader corporate question as it relates to the oncology, after clearly you put a lot of increased manpower into that effort and creating almost an organization within your organization around that and I am just wondering if maybe you can speak to or perhaps that you can speak to the changes within the organization, what you are putting in place and what are the sort of major focal points of how to get out of what we can be looking out within oncology as a group within Radius?

[Robert Ward:]

Yes. So, if you think of what has happened with Radius particularly now that we have completed our most recent offering is it enable us to focus on developing an oncology pipeline, so RAD1901 is very interesting molecule and I think as Dinesh had shared earlier, as we think about Phase 2, there is a number of development option, so first landing on the right guns and then second what going to Phase 2 study that may be combinations or reasons to believe we could consider doing via adjuvant, there could be a potential to explore adjuvant, so there is a number of branch points once again in that Phase 2 dose in hand. The number in our pipeline, RAD-140 is an IND ready asset, its selective androgen receptor modulator. Right now, scientific literature suggest that there is a significant need in triple negative breast cancer and selective androgen receptor modulators have the potential to be therapeutically useful, that’s an area that we would like to explore more continuously so that as we digest our current clinical portfolio that RAD-140 then is able to march forward and move into the clinic, the timing of that really relates on the progress we make on the programs that we have on our plate today, so want to make sure we have continues product innovation, that we are able to scale the organization to ensure that the programs are fully supported by teams who are able to focus on, these different therapeutic or a product related applications and then also to ensure that we have pipeline progress so that as we look at the company over time, we have early stage programs, we have mid stage programs and programs that advance into the final stage of via. So, we look to cross the portfolio today, we look at abaloparatide type subcu having completed the major Phase 3 trials now track in towards MAA and MVA submission and we think the line extension of transdermal patch is a follow on in that same agreement health footprint, vasomotor would be another product that would launch in that same commercial footprint, so it gives us the ability to continue to innovate in a therapeutic area. In oncology 1901 as we explore its potential across breast cancer, we have the potential to come back and evaluate the ovarian cancer or endometrial cancer are suitable for expansion as well as thinking about bringing RAD-140 into clinical development as either complement to 1901 or picks for triple negative, so as we think about the company, our goal is sustainable innovation, building on the portfolio that matures on different time scale, so if the organization is able to move both from the development phase but then also is now growing capabilities so that as the company comes closer to commercialization, we are prepared just to launch a commercialized products as well.

[Mara Goldstein:]

Okay, thank you. I will just jump back in the queue.

[Operator:]

[Operator Instructions] The next question is from John Newman of Canaccord. Please go ahead, sir.

[John Newman:]

Hi, guys. Thanks for taking the question. Question is, when would you make the decision as to whether or not you want to advance RAD1901 as a single agent or in combination, it seems like you are generated some interesting pre clinical data for the combinations, which we also obviously have the Phase 1 study ongoing, just wondering when would you make the decision as to whether or not to take it forward in combination or take it forward as a single agent? Thanks.

[Robert Ward:]

Thanks, John. 140 is very exciting molecule, we saw in the press that Astellas had recently recognized the value of selective androgen receptor modulator, so remember they announced a commitment to this space, so as we think about detail of the evolution of selective androgen receptor modulators, we think it’s going to be a field that “starts to get hot as we move through the next year or two.” So Dr. Hattersley, I know it’s early in our thinking, we haven’t really talked much about 140 perviously, I mean as you think about combos or single agents, does it make sense to start with one of them as the first step or?

[Gary Hattersley:]

Yes, I think you are merging information really reinforces the role of the androgen receptor in metastatic breast cancer not just in ER negative but also an ER positive metastatic breast cancer, so as subscriber that there are some very interesting exciting opportunities as a monotherapy. It also is a potential of combining RAD-140 with another agent as a combo therapy, if something new of course we are very interested in.

[Robert Ward:]

Remember John as we talk about the literature suggesting that there is a potential application, we’re in the process internally of now generating data would be quote our own data, so as we share with you, our thinking today is really based on what we see in the field and what’s happening in the literature in general, as we make progress internally, of course we will come back and share that information with you.

[John Newman:]

Great thank you.

[Operator:]

There are no more questions registered at this time.

[Robert Ward:]

Well, thank you very much Uginia. We appreciate everyone’s involvement in the call here today and we look forward to sharing with you next quarter, the activities and events as they occur going forward. Thank you.

[Operator:]

This concludes today’s conference call. You may disconnect your lines. Thank you for participating and have a pleasant day.