Corbus Pharmaceuticals Holdings, Inc. (CRBP) Q2 2019 Earnings Call Transcript

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Corbus Pharmaceuticals Holdings, Inc.  (NASDAQ: CRBP)
Q2 2019 Earnings Call
Aug. 08, 2019, 8:30 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good morning. Welcome to Corbus Pharmaceuticals Quarterly Update Conference Call and Webcast. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation.

[Operator Instructions] Please note, this conference is being recorded.

I would now like to turn the conference over to your host, Mr. Ted Jenkins, Senior Director, Investor Relations and Corporate Communications. Thank you, sir. You may begin.

Theodore Jenkins -- Senior Director of Investor Relations and Corporate Communications

Good morning, everyone, and thank you for joining us for the Corbus Pharmaceuticals second quarter 2019 update conference call and webcast.

At this time, I'd like to remind our listeners that remarks made during this call may state management's intentions, hopes, beliefs, expectations or projections of the future. These are forward-looking statements and involve risks and uncertainties. Forward-looking statements on this call are made pursuant to the safe harbor provisions of the Federal Securities Laws. These forward-looking statements are based on Corbus' current expectations and actual results could differ materially. As a result, you should not place undue reliance on any forward-looking statements. Some of the factors that could cause actual results to differ materially from those contemplated by such forward-looking statements are discussed in the periodic reports Corbus files with the Securities and Exchange Commission. These documents are available in the Investors section of the company's website and on the Securities and Exchange Commission's website. We encourage you to review these documents carefully.

Joining me on the call today are Dr. Yuval Cohen, our Chief Executive Officer; Dr. Barbara White, our Chief Medical Officer; Sean Moran, our Chief Financial Officer; and Craig Millian, our Chief Commercial Officer.

With that, it is my pleasure to turn the call over to Yuval.

Yuval Cohen -- Chief Executive Officer

Thank you, Ted. Good morning, everyone, and thank you for joining us today. 2019 is so far shaping up to be a busy and eventful year for Corbus, in which we are making important progress toward our corporate, clinical and financial objectives.

I want to remind you all of what our vision is as a company. We believe that targeting the body's endocannabinoid system, also known as the ECS, holds significant potential to provide novel medicines for inflammatory, fibrotic and metabolic diseases. The ECS is a master regulator of these processes in the body through its main two GPCR receptors through ligands and associated enzymes. Since our founding in 2014, we have been focused on discovering, developing and now preparing to commercialize potential novel medications that modulate this powerful biological system. It is our belief that over the coming decade, novel medicines targeting the ECS will potentially reshape treatment options for many diseases. To provide further insight into this, on June 21st of this year, we held our Annual Research and Development Day in New York City. I think it's worthwhile summarizing the three topics we highlighted that morning. First, lenabasum. We continue to advance our four clinical programs. They all remain on schedule. Dr. Barbara White, our Chief Medical Officer, will provide the latest updates for each.

We look forward to the next year, when top line results from our pivotal studies in systemic sclerosis and cystic fibrosis readout along with the Phase II study in systemic lupus erythematosus. Dermatomyositis top line data remains on schedule for 2021. As we approach data readouts, we continue to execute on our vision for commercial agreements in Asia. Earlier this year, we successfully executed a licensing agreement for the rights of lenabasum in Japan with our partner, Kaken Pharmaceuticals, including a $27 million upfront payment with an additional $173 million in potential milestones and double-digit royalties from our future sales in Japan. We look forward to potentially conducting similar deals with lenabasum in other major Asian markets.

An important step in our growth as a company is to begin to lay the groundwork for the expected commercial launch of lenabasum, following the potential FDA approval. This starts with hiring the right people. Craig Millian, who some of you got to meet at our Research and Development Day, was appointed as our Chief Commercial Officer earlier this year. We recently hired Brian Walsh as our Head of Global Marketing. Brian joins us from EMD Serono. We also hired Kaizar Lehri as Head of our Global Supply Chain, who most recently served as Director of Supply Chain Operations at Regeneron. In addition, Dr. Quinn Dinh has been appointed as Vice President of Medical Affairs. A key function as we look forward to launching lenabasum. Quinn joined us from Alnylam. We are also appointing Dr. Robert Discordia to Chief Operating Officer. Bob joined Corbus as Vice President, Pharmaceutical Development and Manufacturing in May of 2018. He brings more than 25 years of biopharmaceutical industry experience in CMC development and business operations to Corbus, most recently as Executive Director, Business Operations and Procurement at Bristol-Myers Squibb. In his new role, Bob will be responsible for optimizing the company's operational efficiency, corporate planning and performance optimization.

Our second topic in our Research and Development Day focused on our new investigational drug CRB-4001, planned to enter its first clinical study later this year. CRB-4001 has demonstrated an effect on metabolism, inflammation and fibrosis in a number of preclinical models that provide a strong case for moving forward into human testing as a potential therapeutic for use in liver, inflammatory, fibrotic diseases such as NASH. We look forward to first-in-human data next year in 2020.

Lastly, our third topic, focused on our proprietary ECS targeting discovery platform. We presented eight preclinical compounds with distinct structures and activity profiles. We expect these will pave the way for future clinical drug candidates and enhance our intellectual property portfolio. Our discovery program provides further validation of our scientific approach and opens the door to potential collaborations with partners, focusing on novel indications and markets.

With that, I'll turn the call over to Dr. Barbara White, our Chief Medical Officer. Barbara?

Barbara White -- Chief Medical Officer

Thank you, Yuval. We continue to advance our ongoing Phase II and Phase III studies. Last subject, first visit in the global RESOLVE-1 Phase III study of lenabasum in diffuse cutaneous systemic sclerosis or SSc occurred on May 1st with 365 subjects enrolled. The last subject, last visit in the double-blind, placebo-controlled part of this study will occur in June 2020. We anticipate top line data in the summer, 2020. The independent data monitoring committee has conducted safety reviews and to-date has recommended that the study continue without change. We are actively preparing for an NDA submission at the end of 2020, should the Phase III data be positive. Safety and efficacy data on the SSc subjects who completed 92 weeks of dosing in the ongoing Phase II open-label extension study of lenabasum were presented at the EULAR 2019 Conference. 29 of the 36 subjects who started the study or 81% remained in the study at 92 weeks.

Lenabasum continues to be safely administered in this open-label extension study with no serious or severe adverse events related to lenabasum reported to-date. The data showed durable improvement in multiple efficacy outcomes, technology limitations of an open-label study. At the time of data cut, ACR CRISS score was 0.95 or greater for month 12 through month 21, change in modified [Indecipherable] and skin score showed improvement of 9.8 or greater points during the same time. These levels of improvement are medically meaningful. Our second ongoing global Phase III study is a 52-week study named DETERMINE, of lenabasum in dermatomyositis. We estimate enrollment of 150 adults with classic or amyopathic dermatomyositis will be complete next year. Safety and efficacy data of the dermatomyositis subjects who completed 68 weeks of dosing in the ongoing Phase II open-label extension study of lenabasum also were presented at the EULAR Conference. 18 of the 20 subjects who started the open-label extension or 90% remain in the study at 68 weeks.

As in the systemic sclerosis open-label extension, lenabasum continues to be safely administered in the DM open-label extension study with no serious or severe adverse events related to lenabasum reported in that Phase II open-label extension so far. Also, as in the systemic sclerosis open-label extension study, the data showed durable [Phonetic] improvement in multiple efficacy outcomes. For example, at the time of data cut, the CDASI activity score showed a mean improvement of minus 21.8 points at month 16, an improvement of minus 4 to minus 5 points in the CDASI activity score is considered medically important. The cystic fibrosis 002 Phase IIb study will be enrolling about 415 subjects with cystic fibrosis who are at high-risk for recurrent pulmonary exacerbations. This study is being done in North America and Europe and is funded in part by a development award for up to $25 million from the Cystic Fibrosis Foundation. Enrollment is expected to complete this year and topline data are expected next summer. If the data are positive, we would plan to discuss potential next steps with regulatory authorities, including a potential marketing authorization application. Lastly, the Phase II study of lenabasum and systemic lupus erythematosus, which is funded and managed by the National Institutes of Health is enrolling subjects at 15 sites in the United States, with a planned total of 100 subjects. We estimate data will be available next year.

The next clinical program for Corbus will be based on developing our first CB1 inverse agonist, CRB-4001 for treatment of non-alcoholic steatohepatitis or NASH. Extensive preclinical data on potentially beneficial effects of CRB-4001 on energy metabolism have been generated to-date, in large part, by Dr. George Kunos and colleagues at the NIH. Corbus has generated additional preclinical data on effects of CRB-4001 on biomarkers of inflammation and fibrosis. These data were presented at our R&D Day in June. Corbus now has an open IND for CRB-4001. We anticipate starting a Phase I single ascending dose, multiple ascending dose safety study of CRB-4001 at the end of this year. In separate studies, we expect the NIH will test CRB-4001 for blood brain barrier penetration and then safety and effects on metabolism and disease biomarkers in subjects with metabolic syndrome or NASH.

To grow our pipeline, we have invested in assembling an internal team with expertise in the biology of inflammation of fibrosis, medicinal chemistry, DMPK and modeling. We are generating new compounds to create a pipeline at Corbus. Our current pipeline focus is on CB2 agonists for treatment of diseases generally characterized by systemic inflammation without fibrosis. We are also focused on generating additional CB1 inverse agonists for lung, heart, liver or kidney diseases with substantial fibrosis. As Yuval mentioned earlier, we presented eight compounds at R&D Day in June and some are moving into animal testing. It is our intention to develop and commercialize some of these compounds ourselves and we will also consider potential partnering options. We are excited about our progress in developing potential new medicines that target the endocannabinoid system for people who suffer from inflammatory, fibrotic or metabolic diseases.

With that, I will turn the call back to Yuval.

Yuval Cohen -- Chief Executive Officer

Thank you, Barbara. Before turning to my closing remarks, I'd like to provide a brief update on our financial position.

Corbus has a strong balance sheet, having ended the quarter with $73 million in cash. Regarding our finances, there is no change in guidance. We have sufficient capital to support operations, clinical development, and commercialization plans into the fourth quarter of 2020. In summer of 2020, we expect to release topline lenabasum data from our completed RESOLVE-1 Phase III systemic sclerosis study and our Phase IIb cystic fibrosis study.

In closing, I would like to emphasize that Corbus is pioneering potentially transformative medicines that target the endocannabinoid system and we believe that this biological system holds the potential to transform how we treat multiple diseases. We are making progress with our late-stage clinical studies and have a pathway toward commercialization of lenabasum. Corbus has a robust pipeline of early stage assets, including a panel of endocannabinoid mimetic compounds. We are identifying and investing in preclinical compounds. We are developing strategic partnerships to expand our growth beyond the US that will increase our market access and allow Corbus to reach patients globally.

With that, I'd like to turn it over to the operator for any questions from our audience today. Operator?

Questions and Answers:

Operator

Thank you. At this time, we will be conducting a question-and-answer session. [Operator Instructions] Our first question comes from the line of Brian Abrahams with RBC. Please proceed with your question.

Brian Corey Abrahams -- RBC Capital Markets -- Analyst

Hi there, thanks very much for taking my questions. My first question was on the ongoing dermatomyositis Phase III. I was wondering if you could talk a little bit about how enrollment's been going so far. I realize it's relatively early days, but curious if there's any learnings there in terms of the types of patients you're seeing and the overall conduct? And then I have a follow-up.

Yuval Cohen -- Chief Executive Officer

Barbara?

Barbara White -- Chief Medical Officer

Certainly, Brian. This is Barbara, thanks for the question. To-date, enrollment is on target. We have activated mostly US sites and most of the patients are from the US. And I would say as I look over the baseline characteristics of those subjects, they are just what we'd hoped for. I think some fairly sick patients who are in need of additional clinical benefit despite state-of-the-art treatment. So, so far we're on target, and I'm pleased with the initial baseline characteristics.

Brian Corey Abrahams -- RBC Capital Markets -- Analyst

That's very helpful.

Barbara White -- Chief Medical Officer

We have a combination, I should say. Sorry, Brian. I just wanted to add. As intended, we have a combination of patients with classic dermatomyositis and if they have a muscle involvement with varying degrees of skin activity or they have largely amyopathic dermatomyositis, which is mostly skin involvement with a lesser or no degrees of muscle of involvement. So as intended, we have both types of subjects in the study.

Brian Corey Abrahams -- RBC Capital Markets -- Analyst

Got it. That's really helpful. Thanks Barbara. And then on 4001, can you maybe talk about some of the gating factors to moving that into the clinic? I guess some of the things that we need to be accomplished between now and the end of the year and can you give us any sense of the timetable for when we might see the NIH's PET data for that program?

Barbara White -- Chief Medical Officer

Sure. Gating for the start of the Phase I study, which will be a reasonably standard SAD/MAD dosing study are the usual gating factors. Completion, availability of clinical supply for the study, which is well under way. Completion of all the selection of the vendors. It would be a single site study. I think and we will update the IND. So all of those things need to be done. I don't anticipate significant difficulties getting any of them accomplished. The one that may be most at risk for delaying time of start-up might be final completion of the clinical trial supply, but our CMC group has that well in hand and under way. I think that the timing of the completion of the blood-brain barrier study and then following that of the study in patients who have metabolic syndrome or NASH at the NIH will depend upon the NIH in part because they will be funding and running that. I would be optimistic that we will have the data that we need to complete the design of at least the blood-brain barrier penetration studies, probably end of first quarter. So then it would take time to get that up. So I would expect results of that again, perhaps some time near the end of summer 2020.

Brian Corey Abrahams -- RBC Capital Markets -- Analyst

That's really helpful. Thanks again and congrats on all the progress.

Barbara White -- Chief Medical Officer

Thank you.

Operator

Our next question comes from the line of Liisa Bayko with JMP Securities. Please proceed with your question.

Liisa Bayko -- JMP Securities -- Analyst

Hi guys. I was wondering if you could just maybe comment a little bit on that you've sort of built up the commercial team a little more, some of your kind of market research findings and then any commercial preparation you're doing and any thoughts on kind of plans, can you go alone for some of these indications in different [Indecipherable]. I know you've partnered some. But just curious on how that's all evolving now that you saw some of those on more senior roles?

Yuval Cohen -- Chief Executive Officer

Thanks, Liisa. I'll deal with one of these and then I'll turn it over to Craig. Just in terms of our commercialization strategy geographically, I think we've made it very clear. We're obviously at the moment, keeping the US and Europe to ourselves. Those are key markets in which we can actually have a direct impact. In terms of Asia, those are very important markets, but for a company of our size and at this stage, it really doesn't make a lot of sense for us to build a commercial presence there. And I think as we've demonstrated in Japan with Kaken, it's much better for us to find a very strong and experienced local partner. Now that we've done in Japan, I think our eyes are turning to some pretty obvious other big Asian markets.

And I'll turn it over to Craig to deal with some of your other questions.

Craig Stuart Millian -- Chief Commercial Officer

Yeah. Hi Liisa, thanks for the question. So just to highlight some of what we've been focused on, obviously early days in terms of commercial planning, but really starting with identifying some of the key hires for our leadership team, as Yuval mentioned, bringing on Brian Walsh, Kaizar on the Supply Chain side as well as a really, a key hire reporting it to Barbara with Dr. Quinn Dinh, heading up Medical Affairs and we're also actively recruiting for a Head of Market Access, which we expect we'll have in place certainly this year. I think that really forms the foundation for a leadership team to bring lenabasum to market.

We've launched planning activities, we've started thinking about go-to-market strategy as well as very early thinking around value and access strategy. We've actually initiated some market research, specifically patient journey market research in both systemic sclerosis and cystic fibrosis. Don't have really top line results yet because we just really started the interviews, but that is work that will be ongoing in the coming weeks. We're working closely with Quinn, our Head of Medical Affairs on really ramping up our kind of KOL engagement planning and execution and we're also looking at increasing our digital and social media presence to really raise awareness of the potential role of targeting the ECS in diseases with significant unmet needs such as systemic sclerosis and cystic fibrosis.

Just a couple of key insights at this point. I have had the opportunity to attend a couple of key conferences, actually, global conferences, EULAR over the summer was in Madrid and then a more niche meeting called the International Workshop on Scleroderma Research, which recently took place in the UK and had the chance to speak with several global KOLs. And I think what really comes across clearly is the tremendous need for new treatment options for systemic sclerosis patients. I think there's disappointment with the results certainly from recent clinical trials within the space. And I can say and I'm sure Barbara would agree that there's great hope and anticipation for lenabasum to get to the finish line as a potential treatment for patients. So again we'll have some results from some market research. We're working with MedAffairs on some advisory boards for later this year to continue to build on our foundation of market insights.

But I think at this point, I'll leave it there, unless there are any other questions.

Liisa Bayko -- JMP Securities -- Analyst

Okay, great. Thanks.

Operator

Our next question comes from the line of Maury Raycroft with Jefferies. Please proceed with your question.

Maurice Thomas Raycroft -- Jefferies -- Analyst

Good morning everyone and thank you for taking my questions. I'm just wondering on the recent DMC [Phonetic] review for systemic sclerosis. Just wondering if you can remind how often the DMC meets? And if they have anything pre-specified that they're looking for on the efficacy side that could trigger a trial adjustment?

Yuval Cohen -- Chief Executive Officer

Thanks, Maury. Barbara?

Barbara White -- Chief Medical Officer

Hi. Yes, this is Barbara. They meet every six months or sooner if we ask and request them for any particular safety signal. They would also receive any in writing, the Chairperson would receive any, again, things such as a SUSAR. And so they look over -- they have access to unblinded data. They focus on safety. They have unblinded safety data and efficacy data available to them, should they choose to look at. And so far, it's my understanding that they have been satisfied with the valuation of the blinded data.

Maurice Thomas Raycroft -- Jefferies -- Analyst

Got it. Thank you. And for the mRSS endpoint, just wondering if there's any general perspective that you can offer on how FDA will review and waive this endpoint even though it's now a secondary?

Barbara White -- Chief Medical Officer

As you know, it's always difficult to speak for the FDA. So certainly, this is just my perception. I think they will look at it with great interest. It has been the standard that has been used as a primary efficacy outcome for many years and they are familiar with it. At the same time, I think they are very cognizant of its shortcomings, which include inability to-date, in large part, to discern a treatment effect when other data might suggest that a treatment effect is available. Its variability and measurement and its difficulty in using in a global study, especially if some slightly less experienced investigators are involved. So as they told us directly, they will look at the totality of the data. I believe that they will look at each of the five components of the ACR CRISS itself, including several patient reported outcomes. I think those will be of interest to them as will be the mRSS that measure skin and force vital capacity on measure of lung.

Maurice Thomas Raycroft -- Jefferies -- Analyst

Got it. That's all. And thank you for taking my questions.

Yuval Cohen -- Chief Executive Officer

Thanks Maury.

Operator

[Operator Instructions] Our next question comes from the line of Ted Tenthoff with Piper Jaffray. Please proceed with your question.

Edward Andrew Tenthoff -- Piper Jaffray -- Analyst

Craig, thank you very much for the update and I enjoyed very much the R&D day. My question has to do sort of with the earlier discovery efforts and I was really impressed with this, the depth and breadth of the library and the ability to identify new candidates for inflammatory diseases. So I want to get a sense of sort of what you see as the productivity rate that you'd shoot for in terms of new discoveries? I appreciate that you can never really control that, but what do you think is capable from the team in terms of generating new candidates like 4001? Thanks.

Yuval Cohen -- Chief Executive Officer

Ted, thanks for that question. Sorry, Barbara. I'll deal with the first bit and then Barbara will fill in the rest of it.

What I wanted to say is, I agree and we are very, very excited about this. Obviously, all eyes are on the lenabasum appropriately so with a launch as early as 2021 and the type of impact we think lenabasum will have. It's perfectly normal that people -- investors and shareholders will focus on that. But if we think about Corbus and take a step back and think of us as a company that really wants to be a leader, an established dominance over what is really an entire biological system, this endocannabinoid system, then it's clear that we need more than lenabasum. Lenabasum will be just the first of hopefully many successful drugs. And to do so I think that we have very proactively invested in first and foremost, people and building this team, which I think is really unrivaled in terms of the expertise that it has, in terms of how they function together and they are laser-focused on the endocannabinoid system and on generating screening and then moving preclinical and clinical, these new chemical entities. And I think that as we see these compounds come to the fore and we started with just the first group out of the library, we will obviously give you updates starting from, obviously, in vitro as we did before. Next, you should expect to see a key animal data and then starting the dialogue around the potential indications for that.

And I also want to remind, Ted you and our audience that the advantage of doing so isn't only bringing in new drugs to the market. We will always, always have a limited ability in terms of how many drugs we can develop in-house, no matter how big we become. So the advantage of doing what we're doing is it opens the door for the first time to some real pharma collaborations on the early stages of development and we look around to some of our peers and some of our very successful peers and one of the things that we've at least concluded is to become a very successful company in our field, it is really imperative to start building those relationships. You cannot do this on your own. So that was sort of the general overview.

And Barbara, please fill in anything that I may have forgotten.

Barbara White -- Chief Medical Officer

Thank you, Yuval. We think and we plan to from our emerging compounds that undergo the initial screen, be able to generate probably two candidates that will -- per year that would undergo subsequent, a more detailed DMPK animal model testing with the goal of having one or two of those actually enter Phase I testing each year, starting in 2020. So we will move 4001 at the end of this year, and our plan would be to move at least one additional compound into Phase I testing next year and each subsequent year from what we generate ourselves.

Edward Andrew Tenthoff -- Piper Jaffray -- Analyst

Great. I really appreciate that. And thank you for the update.

Operator

Our next question comes from the line of George Zavoico with B. Riley. Please proceed with your question.

George Zavoico -- B. Riley -- Analyst

Hi everyone. Good morning everyone. Thanks for the update.

Yuval Cohen -- Chief Executive Officer

Good morning George.

George Zavoico -- B. Riley -- Analyst

So clearly, you're preparing for commercial launch with this slew of hires. I wanted to ask about how that plan is going with regard to the number of different indications here going after scleroderma and dermatomyositis, of course? First, with regard to CMC, are you planning ultimately to bring manufacturing in-house, which would require a much more individualized or personalized that were CMC kind of work? And is there any overlap with the two diseases or would you require two separate sort of initiatives with your personnel with medical affairs and marketing?

Yuval Cohen -- Chief Executive Officer

George, good morning. I'll start with the CMC, and then I'll turn it over to Craig.

We have absolutely no intention of building CMC capacity in-house. As you know, one of the things we really pride ourselves on is a very, very lean and very capital-efficient model. We started Corbus, again, just five years ago. And our pipeline I think is certainly a testament to the very rapid progress we've made and very, very efficient use of capital. So we absolutely have no intention of doing CMC in-house.

Craig, comment on George's in terms of the two indications.

Craig Stuart Millian -- Chief Commercial Officer

Yeah, sure. So thanks for the question, George.

So our initial potential indications would be in systemic sclerosis and cystic fibrosis with dermatomyositis likely coming later. So I think our strategy would be to build out our go-to-market model, really with an emphasis on optimizing our launch and commercial success, first and foremost, in systemic sclerosis, which we view as a condition with significant unmet patient need. There's very few treatment options. In fact, there's none indicating specifically for systemic sclerosis and really a sizable commercial potential. So we believe there's an opportunity to leverage certainly a customer-facing team as well as digital channels, first to target those centers of excellence that treat scleroderma, specifically, there's about 50 of those. But also potentially to branch out even into the community with rheumatologists who are often making an initial diagnosis and then seeing systemic sclerosis patients early in the disease progression before they refer them.

So we build that, and we'll be able to leverage a lot of those commercial capabilities that we build, for example, you think about marketing, market access, commercial operations, all our CRM-type systems, then to also potentially launch into cystic fibrosis. With CF, we would need to add a separate sales team, but a very small one, I would say, because that treatment is highly concentrated in about 130 or so CF treatment centers. So that would really be our starting point. And then, obviously, there would be significant synergies with a potential launch into dermatomyositis, which is also typically treated by rheumatologists and we'd be able to really leverage the infrastructure that we would have built for systemic sclerosis to then pursue dermatomyositis.

So hopefully, that addresses the question. Thanks, George.

George Zavoico -- B. Riley -- Analyst

Yeah. That helps. But you mentioned rheumatologists in the community level for referral, do you ultimately see the community of rheumatologists actually diagnosing and taking over treatment or do you expect most of the patients to be referred to specialists?

Craig Stuart Millian -- Chief Commercial Officer

Right. Yeah. No, it's a great question. I think right now, I think we're just generating hypotheses around that. Certainly because of the dearth of current treatment options, a lot of treatment had to happen in the centers of excellence. Again, there's nothing specifically indicated for systemic sclerosis. So it often comes down to a particular specialist treating a particular manifestation of the disease based on organ involvement. The opportunity, obviously, with lenabasum, and of course, we have to wait to see what the data tell us. But depending on the ultimate benefit risk profile could certainly be very attractive in terms of an oral option for rheumatologists to treat patients earlier on in their disease progression, which is important because a lot of the damage is done early on in disease progression before patients are even referred to those centers of excellence. So certainly an opportunity, one that we have to do a lot more work to assess. And whether it's something that we need to hire salespeople to do that or if there's other efficient ways through multichannel marketing, for example, digital, etc. We'll figure that out in due course. But that's kind of the hypothesis at this point.

George Zavoico -- B. Riley -- Analyst

That's what I was thinking about it because it is an oral option. Because it is an oral drug and it's safe so far. And hopefully, it will stay that way. It should be -- I'm looking perhaps to having community rheumatologists actually do the prescribing early on as you suggest for perhaps for greater benefit. But as you say, I mean, it is a process of assessing and hopefully something like that will evolve in time, in due course.

With regard to CF --

Craig Stuart Millian -- Chief Commercial Officer

[Indecipherable]

George Zavoico -- B. Riley -- Analyst

Sorry.

Craig Stuart Millian -- Chief Commercial Officer

Go ahead. Sorry.

George Zavoico -- B. Riley -- Analyst

With regard to CF, last question, this path has been followed with other CF drug companies. And so are you using some of those as a model? You don't have a precedent for sclerosis and dermatomyositis but with cystic fibrosis, there's a lot of marketing data and other information you can use? Are you leveraging any of that?

Craig Stuart Millian -- Chief Commercial Officer

So yeah. So I'll take that, George. Yes, I think there's obviously a really good precedent set with Vertex and the success that they've had with what I would say is an extremely efficient go-to-market model with a very focused customer facing team, I think probably 20 or so individuals, highly trained, focused on the centers of excellence that treat cystic fibrosis. As you mentioned, unlike systemic sclerosis and dermatomyositis, there's not a lot of mystery in terms of where the CF patients are, who's treating them. It's highly concentrated. So it really allows for a very efficient model that would combine, obviously, calling on those centers as well as some mechanism to provide patient services directly to patients and that would be kind of the model we would look at there.

George Zavoico -- B. Riley -- Analyst

Okay, great. Thanks very much.

Yuval Cohen -- Chief Executive Officer

Thank you, George.

Operator

[Operator Closing Remarks]

Yuval Cohen -- Chief Executive Officer

Thank you, everyone.

Duration: 41 minutes

Call participants:

Theodore Jenkins -- Senior Director of Investor Relations and Corporate Communications

Yuval Cohen -- Chief Executive Officer

Barbara White -- Chief Medical Officer

Brian Corey Abrahams -- RBC Capital Markets -- Analyst

Liisa Bayko -- JMP Securities -- Analyst

Craig Stuart Millian -- Chief Commercial Officer

Maurice Thomas Raycroft -- Jefferies -- Analyst

Edward Andrew Tenthoff -- Piper Jaffray -- Analyst

George Zavoico -- B. Riley -- Analyst

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