Q2 2019 Earnings Call
BF-WATCH TV: BF-WATCH TV 2021
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 form of a presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad.
Good morning, welcome to Corpus Pharmaceuticals quarterly update conference call and webcast. At this time all participants are in a listen only mode. A question, that's especially will follow the formal presentation. If anyone should require operator systems. During the conference. Please press star zero on your telephone keypad. Please note. This conference is being recorded.
Operator: Please note, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Ted Jenkins, Senior Director of Investor Relations and Corporate Communications. Thank you, sir.
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.
Ted Jenkins: You may begin. 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 that involve risks and uncertainties. Forward-looking statements in this call are made pursuant to the safe harbor provisions of the federal securities laws. These forward-looking statements are based on Corbus's current expectations, and actual results could differ materially. As a result, you should not place undue reliance on any forward-looking statements.
Good morning, everyone and thank you for joining us for the call just 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 predictions of the future.
These are forward looking statements 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 Corpus this 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 call radical ports Corpus files with the Securities Exchange Commission.
Ted Jenkins: with the Securities Exchange Commission. These documents are available in the investor section of the company's website and on the SEC's website.
These documents are available in the Investor section of the company's website and on the Securities Exchange Commission website. We encourage you to review these documents carefully.
Ted Jenkins: We encourage you to review these documents carefully.
Joining me on the call today are Dr., you've all Cohen, our Chief Executive Officer.
Ted Jenkins: Joining me on the call today are Dr. Yuval Cohen, our Chief Executive Officer, and Dr. Barbara White, our Chief Medical Officer.
Dr Barber White, our Chief Medical Officer.
Ted Jenkins: Sean Moran, Chief Financial Officer; Craig Millions, Chief Commercial Officer. With that, my
Sean Rand, our Chief Financial Officer.
Greg Williams, Chief commercial officer.
With that it's my pleasure to turn the call over to you all thank you Jay and good morning, everyone and thank you for joining us today.
Yuval Cohen: It is my pleasure to turn the call over to you all. Thank you, Ted.
Yuval Cohen: 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 towards 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 ECM, 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, their ligands, and associated enzymes.
2019, as so far shaping up to be a busy and eventful year for corpus in which we are making important progress towards 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 bodies Endocannabinoid system also known as the E. C. S holds significant potential to provide novel medicines for inflammatory five right and metabolic diseases.
The E. C. S is the master regulator of these processes in the body fluids. Its name to GPC are receptors, there like ads 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.
Yuval Cohen: 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 mechanism. 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, Linnabis.
It is our belief that over the coming decade novel medicines targeting that you see us will potentially be sheep treatment options for many diseases.
To provide further insight into this on June 20, Onest 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 Lynn Madison.
We continue to advance our for Threeq or Fourq clinical programs. The all remain on schedule.
Yuval Cohen: We continue to advance our four clinical programs, and they all remain on schedule. Dr. Barbara White, our Chief Medical Officer, will provide the latest updates for you. We look forward to the next year when top-line results from our pivotal studies in systemic sclerosis and cystic fibrosis will be read out, along with the Phase 2 study in systemic lupus erythematosus. Dermatomyositis top line data remains on schedule for 2021.
Dr. Barbara White, our Chief Medical Officer will provide the latest updates for each.
We look forward to the next two to the next year.
When topline results from our pivotal studies and systemic sclerosis, and cystic fibrosis weed out along with the phase two study and systemic systemic lupus erythematosus.
They're matter myositis topline data remains on schedule for 2021.
As we approach data read outs, we continue to execute on our vision for commercial agreements in Asia.
Yuval Cohen: 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 to Nabisim in Japan with our partner, Kakin Pharmaceuticals, including a $27 million upfront payment, with an additional $173 million in potential miles, and double-digit royalties from our future sales in Japan. We look forward to potentially conducting similar deals with Madison in other major agencies.
Earlier this year, we successfully executed a licensing agreement for the rights to the NAV system in Japan, with our partner CAC and pharmaceuticals.
Including a $27 million upfront payment.
With an additional $173 million in dollars and potential milestones.
And double digit royalties from our future sales in Japan.
We look forward to potentially conducting similar deals with analysis in other major Asian markets.
Yuval Cohen: An important step in our growth as a company, to begin today the groundwork for the expected commercial launch of Lenabisin following the potential SDA approval. This starts with hiring the right people. Craig Million, 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 Sirona. We also hired Kaiser Larry as head of our global supply chain, who most recently served as Director of Supply Chain Operations at Regeneron. In addition, Dr. Quindon has been appointed as Vice President of Medical Affairs, a key function as we look forward to launching the NAVA. Queen joins us from Elm Island.
An important step in our growth as a company is to begin to lay the groundwork for the expected commercial launch of the Madison following the potential FDA approval.
This starts with hiring the right people.
Craig million 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 MZ Sirona.
We also hired.
Kaiser Larry as head of our global supply chain, who most recently served as director of supply chain operations at Regeneron.
In addition, Dr. Clayton has been appointed as Vice President of Medical Affairs at key function as we look forward to launching the Madison.
Quinn joins us from El Nio.
We are also pointing dr. Robert to scored yet to chief operating officer.
Bob joined Cordis, as Vice President pharmaceutical development and manufacturing in May of 2018.
He brings more than 25 years of biopharmaceutical industry experience and CMC development and business operations to Corpus most recently as executive director business operations and procurement at Bristol Myers Squibb.
Yuval Cohen: 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.
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 four 001.
Time to enter its first clinical study later this year.
CRB four 001 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 inflammation inflammatory side roddick diseases, such as Nash.
We look forward into first in human data next year in 2020.
Lastly, our third topic focused on our proprietary E. C. S targeting discovery platform, we presented eight preclinical compounds with distinct structures and activity profile. We expect these will pave the way for future clinical drug candidates and enhance our intellectual property portfolio.
Barbara White: Our second topic at our Research and Development Day focused on our new investigational drug, CRB4001. We plan to enter its first clinical study later this year. CRB4001 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 data in humans 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 invocations and the market, With that, I'll turn the call over to Dr. Barbara White, our Chief Medical Officer.
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.
Thank you Paul.
We continue to advance our ongoing phase two and phase three studies.
Last subject first visit in the global resolved one phase three study of one Alison and diffuse cutaneous systemic sclerosis or SST 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 topline data in the summer 20 Cline.
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 anda submission at the end of 2020 should the phase three data be positive.
Safety and efficacy data on the SSC subjects, who completed 92 weeks of dosing in the ongoing phase two open label extension study of one Alison were presented at the EULAR 2019 conference.
29 of the 36 subjects, who started the study or 81% remained in this study at 92 weeks.
Barbara White: Thank you, Yuval. We continue to advance our ongoing Phase 2 and Phase 3 studies. The First Subject First Visit in the Global Resolve-1 Phase III Study of Lanabasum in Diffuse Cutaneous Systemic Sclerosis, or SSC, occurred on May 1, 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
Whenever some continues to be safely administered in this open label extension study with no serious or severe adverse events related to Annapolis unreported.
[noise] the data showed durable improvements in multiple efficacy outcome acknowledging limitations have an open label study.
At the time of data cut.
A CR, Chris score was 0.95 or greater from month 12 through months 21.
Change in modified Broadness 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 three study is a 52 week study named determine.
Barbara White: The Independent Data Monitoring Committee has conducted safety reviews and, to date, has recommended that this study continue without change. We are actively preparing for an NDA submission at the end of 2020, should the Phase III data, Safety and efficacy data on the SSC subjects who completed 92 weeks of dosing in the ongoing Phase II Open Label Extension Study of Lenabicin be presented at the ULAR 2019 Conference. 29 of the 36 subjects who started the study, or 81%, remained in the study at 92 weeks.
<unk> whenever some inter matter myositis, we estimate enrollment of 150 adults with classic are aimed myopathy tamaddon myositis will be complete next year.
Safety and efficacy data of the dramatic myositis subjects, who completed 68 weeks of dosing in the ongoing phase two open label extension study of one Alison.
Also were presented at the EULAR conference.
18 of the 20 subjects, who started the open label extension or 90% remain in this study at 68 weeks.
Barbara White: Lanabasum continues to be safely administered in this Open Label Extension Study with no serious or severe adverse events related to Lanabasum reported. The data showed durable improvement in multiple efficacy outcomes, acknowledging limitations of an open-label study. At the time of data cut, ACR CRISP score was 0.95 or greater from month 12 through month 21, and Change in Modified Rodness Skin score showed improvement of 9.8 or greater points during the same time.
Isn't that systemic sclerosis open label extension well Inaba. Some continues to be safely administered in the DM open label extension study with no serious or severe adverse events related to when Atlas.
Reported in that phase two open label extension so far.
Also as any systemic sclerosis open label extension study.
The data.
Show durable improvement in multiple efficacy outcome.
For example, at the time of data cuts.
See I see activity score it showed a mean improvement of minus 21.8 points at month six team.
Barbara White: These levels of improvement are medically meaningful. Our second ongoing Global Phase III study is a 52-week study, named DETERMIN, of linabasim 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 patients who completed 68 weeks of dosing in the ongoing Phase II Open Label Extension Study of Lenabasem were also presented at the UR conference. 18 of the 20 subjects who started the Open Label Extension, or 90%, remain in the study at 68 weeks.
And improvement of minus four to minus five points in the sea Daffy activity score is considered medically important.
The cystic fibrosis C or zero two phase two b study well 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.
Barbara White: As in the systemic sclerosis open-label extension study, linabasam continues to be safely administered in the DM open-label extension study with no serious or severe adverse events related to linabasam reported in that phase two open-label extension so far. Also, as in the systemic sclerosis open-label extension study, The data showed durable 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.
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 two study of one Alison systemic lupus erythematosus, which is funded and managed by the National Institutes of health is enrolling subjects. If 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 Corpus will be based on developing our first CB one inverse agonist CRB 4001 for treatment with non alcoholic steatohepatitis or Nash.
Barbara White: An improvement of minus 4 to minus 5 points in the CDASI activity score is considered medically important. The Cystic Fibrosis 002 Phase 2B study will be enrolling about 415 subjects with cystic fibrosis who are at high risk for recurrent pulmonary exacerbations. The 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. Recruit is expected to complete this year, and top-line data are expected next summer.
Extensive preclinical data on potentially beneficial effects. The CRB 4001 on energy metabolism have been generated to date.
In large part by Dr., George Cuno, some colleagues at the NIH.
Corpus has generated additional preclinical data on effects of CRP 4001 on Biomarkers of inflammation and fibrosis. These data were presented at our R&D day in June .
[noise] Corpus now has an open eye on D. for CRB 4001.
We anticipate starting a phase one single ascending dose multiple ascending dose safety safety study of CRB 4001 at the end up this year.
Barbara White: If the data are positive, we would plan to discuss potential next steps with regulatory authorities, including a potential marketing authorization application. Lastly, a Phase II study of lenabifim 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.
In separate studies, we expect the NIH will test CRB 4001.
For blood brain barrier penetration.
And then safety in effect, some 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 fibrosis medicinal chemistry, D.M. PK and modeling.
Barbara White: The next clinical program for Corbus will be based on developing our first CB1-inverse agonist, CRB4001, for treatment of non-alcoholic steatohepatitis, or NASH. Extensive preclinical data on potentially beneficial effects of CRB4001 on energy metabolism have been generated to date, in large part, by Dr. George Kunos and colleagues at the University of California, Berkeley; Corbus has generated additional preclinical These data were presented at our R&D day in June.
We are generating new compounds to create a pipeline corpus.
Our current pipeline focus is on C. B two agonists for treatment of disease is generally characterized by systemic inflammation with Iraq without fibrosis.
We're also focused on generating additional CB, one inverse agonists.
For long heart liver or kidney diseases with substantial fibrosis.
As Youve all mentioned earlier, we presented to date compounds at R&D day in June .
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.
Yuval Cohen: Corbus now has an open IND for CRB4001, and we anticipate starting a Phase 1 single ascending dose, multiple ascending dose safety study of CRB4001 at the end of this year. In separate studies, we expect the NIH will test CRB4001 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 of corroborants. Our current focus is on CB2 agonists for the 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.
We are excited about our progress in developing potential new medicines that target the endocannabinoid system for people, who suffer from inflammatory pipe roddick or metabolic diseases with that I will turn the call back to you all.
Thank you Barbara.
Before turning to my closing remarks, I would like to provide a brief update on our financial position.
Well this 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 top line than absent data from our completed resolved one phase three systemic sclerosis study and our phase to be cystic fibrosis study.
In closing I would like to emphasize.
The core business pioneering potentially transformative medicines the target the endocannabinoid system.
And we believe that this biological system holds the potential to transform how we treat multiple diseases.
We're making progress with our late stage clinical studies.
And have a pathway to move towards commercialization of Annapolis.
Yuval Cohen: As you all 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 you all.
[noise] Corpus has a robust pipeline of early stage assets, including a panel of and broken out of the nordmann Mehdi compounds.
We are identifying and investing in preclinical compounds.
We are developing strategic partnerships to expand our growth beyond the U.S. that will increase our market access analog allow corbett to reach patients globally.
With that I'd like to turn it over to the operator for any questions from our audience today operator.
Thank you.
At this time, we'll be conducting a question and answer session.
If you'd like to ask a question. Please press star one on your telephone keypad.
A confirmation so indicate your line is in the question queue. You May proceed with your what's your movie question from the Q.
For participants using speaker equipment, it may be necessary to pick up your handset before person Starkey one moment. Please while we poll for questions.
Our first question comes the line of Brian Abrahams with RBC.
Yuval Cohen: 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.
Please proceed with your question.
Hi, there thanks very much for taking my questions. My first question was on the I'm going to matter Myositis phase three I'm. Just wondering if you could talk about I'm, a little bit about how enrollment has been going so far I realize it's.
Relatively early days, but curious if there's any learnings there and in terms of the types of patients you are seeing in the overall conduct and then I had a follow up.
Operator: Fish and Capital to support operations, clinical development, and commercialization plans into the fourth quarter of 2020. In the summer of 2020, we expect to release top-line Manavisim data from our completed Resolve 1 Phase 3 Systemic Sclerosis Study and our Phase 2b Cystic Fibrosis Study. In closing, I would like to emphasize that Corbus is pioneering potentially transformative medicines that target the endocannabinoids, 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 lanabis. Corbus has a robust pipeline of early-stage assets, including a panel of endocannabinoid mimetic compounds. Additionally, we are identifying and investing in pre-clinical compounds. We are developing strategic partnerships to expand our growth beyond the U.S. 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?
Barbara.
Certainly Brian this is Barbara Thanks for the question to date enrollment is on target we have activated mostly U.S. sites. So most of the patients are from the U.S. and I would say as I look over a good baseline characteristics of those subjects. They are.
Just what we'd hoped for I think things some fairly sick patients who are in need of.
Additional clinical benefits despite.
State of the art treatment so.
So far were on target and I'm pleased with the initial baseline characteristics.
That's very helpful and then combination I should say.
Sorry, Brian I, just wanted to add some comment when you have a combination of patients with classic truck not on my side. It's obvious they have muscling, Oh, no I'm with varying degrees of skin activity, where they have largely in my past victim, Adam aside which is most skin involvement with that so I would agree so muscle involvement. So as intended we have those types of subjects in the study.
Got it that's really helpful. Thanks, Barbara and then Oh four 001.
Can you maybe talk about some of the gating factors to moving that into the clinic I guess what are the things some of the things that we need to be accomplished between now and the ended the year and can you give us any sense of the timetable for when we might see the NIH is pet data for that program.
Operator: Thank you. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad, followed by confirmation to indicate your line is in the question queue. You may press start to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start button.
Sure.
Gating for the start of the Phase one study, which will be a reasonably standard S. 80, M.I.D. dosing study are the usual gating factors completion or availability of clinical supply for this study, which is well underway.
Completion of all the selection of the vendors.
It would be a single site study.
I think and we will update the I.N.D. So all of those things need to be done I don't anticipate significant difficulties getting any of them them accomplished the one that may be most at risk for delaying time, a start up might be final completion of the clinical trial supply, but our CMC group has sat.
Brian Abrahams: One moment, please, while we pull for questions. Our first question comes from the line of Brian Abrahams with RBC. Please see the question with the answer, Hi there. Thanks very much for taking my questions. My first question was about the ongoing dermatomyositis phase 3 study. I was wondering if you could talk a little bit about how enrollment has been going so far. I realize it's relatively early days, but I'm curious if there are any learnings there in terms of the types of patients you're seeing and the overall conduct.
Well in hand and underway.
I think that the timing of the completion of the blood brain barrier study and then following that D study in patients who have metabolic syndrome or how should the NIH will depend upon the NIH in part because they will be funding running that I would be optimistic that we will have the data that we need to complete the design or at least the blood brain barrier penetration studies.
Barbara White: Barbara?
Barbara White: Certainly, Brian. This is Barbara.
Barbara White: Thanks for the question. Today's enrollment is on target. We have activated mostly U.S. sites, so most of the patients are from the U.S., 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 So, so far, we're on target, and I'm pleased with the initial baseline characteristics
Oh, hopefully he and into first quarter.
So then it would take time to get that up so I would expect results of that again, perhaps sometime near the end of summer 2020.
Barbara White: That's very helpful. We have a good combination, I should say.
[noise] [noise], that's really helpful. Thanks, again and congrats on all the progress.
Oh, thank you.
Barbara White: I just wanted to add, as intended, we have a combination of patients with classic dermatomyositis, that is, they have muscle involvement with varying degrees of skin activity, or they have largely myopathic dermatomyositis, which is mostly skin involvement with lesser or no degrees of muscle involvement. So, as intended, we have both types of subjects in the study.
Our next question comes on line of Liisa Bayko with JMP Securities. Please proceed with your question.
Hi, guys I was wondering if you could just maybe comment a little bit on that you can sort of built up the commercial team Omar.
Somebody or 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 and different world area, then a partner or something but just curious on how that's all evolving now that you you felt some of those on marcial.
Barbara White: Got it. That's really helpful. Thanks, Barbara. And then on 4001, could you maybe talk about some of the gating factors for moving that into the clinic? I guess, what are the things, some of the things that would 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 NIH's PET data for that program?
Thanks, Lisa 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 U.S. 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 does not make a lot of sense for us to build a commercial presence there and I think as we've demonstrated in the hands of CAC and it's much better for us to find a very strong it experienced a local partner now that we've done in Japan, I think our eyes are turning to Ah some pretty obvious other big Asian markets and I'll turn it over to Craig to deal with some of your other question.
Barbara White: Sure, gating for the start of the phase one study, which will be a reasonably standard SAD, MAD dosing study, are the usual gating factors. Completion of availability of clinical supply for the study, which is well underway. Completion of all selection of the vendors. It would be a single site study.
Yeah, Hi, Lisa Thanks. Thanks for the question. So just you know just to highlight some of what we've been focused on obviously early days in terms of commercial planning, but they're really starting with you identifying some of the key hires for our leadership team as you all mentioned, bringing on Brian Walsh.
Barbara White: 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 startup might be the final completion of the clinical trial supply. But our CMC group has that well in hand and underway. I think that the timing of the completion of the blood-brain barrier study and then following that with 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 by the end of the first quarter. But then it would take time to get that up. So I would expect results of that again perhaps sometime near the end of summer 2020.
Kaiser on the supply chain side as well as really a key hire reporting at the Barbara with a Doctor quick question, Dan heading up Medical Affairs, and we're also actively recruiting for ahead of market access, which we expect will have in place certainly this year, but I think that really forms the foundation for her leadership team to bring went out to some mark to market.
We've we've kicked off a launch planning activities, we started thinking about go to market strategy as well as you know very early thinking around value an 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 topline results yet because we just really started to be interviews, but that is that is work that will be ongoing in the coming weeks, we're working closely with with Quinn or head of medical affairs on ramping up our kinda K well engage me a 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 you see us in diseases with significant unmet needs such as systemic sclerosis, and cystic fibrosis.
Barbara White: That's really helpful. Thanks again and congrats on all the progress.
Barbara White: Well, thank you.
Lisa Bacow: Our next question comes from Lisa Bacow with J&P Securities. Please state your question. Hi guys, I was wondering if you could just maybe comment a little bit on how 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 and in different world areas? I know you partner some, but I'm just curious how that's all evolving now that you've filled some of those more senior roles.
Just a couple of key insights at this point I have had the opportunity to attend a couple of key conferences are actually global conferences. You are over the summer was in Madrid, and then B a more niche meeting called International workshop on Scleroderma Research, which recently took place in the UK and had the chance to speak with several global K. Wells and I think what really comes across clearly the tremendous need for new treatment options for systemic sclerosis patients.
I think that there's disappointment with the results from certainly with some recent clinical trials within that space and I can say and I'm sure Barbara would would agree that there's great hope in anticipation for when added some to get to the finish line as a potential treatment for patients. So again, we'll have to some results from some market research, we're working with Med affairs on some advisory boards for later this year to continue to build on our foundation of a market insights.
Yuval Cohen: Thanks, Lisa. I'll deal with one of these and then I'll turn it over to Craig.
Yuval Cohen: Just in terms of our commercialization strategy... Geographically, I think we've made it very clear that, at the moment, we're obviously keeping the U.S. 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 does not make a lot of sense for us to build a commercial presence there. I think, as we've demonstrated in Japan with Kakin, it's much better for us to find a very strong and experienced local partner. Now that we've done Japan, I think our eyes are turning to some pretty obvious other big Asian markets. I'll turn it over to Craig to deal with some of your other questions.
But I think at this point I'll I'll leave it there unless there are any other questions.
Okay, great. Thanks.
Our next question comes in line or more Rycroft with Jefferies. Please proceed with your question.
Hi, Good morning, everyone and thank you for taking my question.
I'm just wondering on the recent DMC review for systemic sclerosis, just wondering if you can remind us 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.
Thanks, Lori Barbara.
Hi, Yes. This is Barbara they need every six months or sooner if we asked them requesting for any particular.
Safety.
Signal they would also receive any.
Craig Millions: Hi Lisa, 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 you've all mentioned, bringing on Brian Walsh, Kaiser, on the supply chain side, as well as really a key hire reporting to Barbara with Dr. Quindin 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. And I think that really forms the foundation for a leadership team to bring Len Abism to market.
In writing the chairperson would receive any again things such as <unk> SAR and so they look over they have access to on blinded 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.
Got it okay, Thank you and or the M.R.S.S. and point I'm just wondering if there's any general perspective that you can offer on how F.D.A. will review in way this endpoint, even though it's in our secondary.
Craig Millions: We've kicked off launch planning activities. We've started thinking about the go-to-market strategy, as well as very early thinking around value and access strategies. We've actually initiated some market research, specifically patient journey market research in both systemic sclerosis and cystic fibrosis. We don't have any 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.
I have.
As you know, it's 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 to supply married efficacy outcome for many years.
And they are familiar with it.
At the same time, I think they're very cognisant 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.
Yeah.
Variability in management.
And its difficulty in using a new 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.
Craig Millions: Just a couple of key insights at this point. I have had the opportunity to attend a couple of key conferences, actually global conferences. ULAR over the summer was in Madrid and then at a more niche meeting called the International Workshop on Scleroderma Research, which recently took place in the U.K., and I 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 this space, and I can say, and I'm sure Barbara would agree, that there's great hope and anticipation for Linavisim 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.
I believe that they will look at each of the five components of the SCR, Chris itself, including several patient reported outcomes I think those would be of interest to them.
As will be DMR assess it makes your skin and forced vital capacity how miserable.
Got it that's helpful and Ah Ah. Thank you for taking my questions.
Yeah. Thanks Laurie.
Once again, if you would like to ask a question. Please press star one on your telephone keypad. Once again, if you would like to ask question. Please press star one on your telephone keypad.
Our next question comes on line of Ted Tenthoff with Piper Jaffray. Please proceed with your question.
Great. Thank you very much for the update and I enjoyed very much. The R&D day. My question has to do sort of with earlier discovery a hurt.
I was really impressed with this.
The depth and breadth of the library and the ability to identify all right.
Candidates.
For.
You know inflammatory diseases. So I wasn't give a sense of sort of what you see is the productivity rate. The two poor in terms of new discoveries.
Appreciate it but you can never really.
All that but what do you think is capable for the team.
So to the rating.
Kevin It's like four 001 thing.
Hey, Thanks, Thanks for that question, Oh, sorry about that.
Lisa Bacow: Okay, great. Thanks.
Maureen Raycroft: Our next question comes from the line of Maureen Raycroft with Jefferies. Please see with your question. Hi, good morning, everyone, and thank you for taking my questions.
I'll I'll deal with the first bit member, but it will fill in the rest of it.
The what I wanted to say I agree I'm. We are very very excited about this obviously all eyes are on the Nab them appropriately. So we have a launch as early as 2021 and the type of impact. We can go now this and we'll have it's it's perfectly normal that people would investors and shareholders will focus on that.
Maureen Raycroft: I'm just wondering about the recent DMC review for systemic sclerosis; I just wondered if you could remind me 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.
But if we think about corbis and take a step back and think of us as a company that really wants to be a leader.
Barbara White: Thanks, Laurie. Barbara?
Barbara White: Hi. Yes, this is Barbara.
Barbara White: 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 out for them; 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 it. And so far, it's my understanding that they have been satisfied with the evaluation of the blinded data.
And establish dominance over what is really an entire biological system. This endocannabinoid system. Then it's clear that we need more than that now the fanatics will be just the first of hopefully many successful drugs and to do so I think that we have a very proactively invested in first and foremost people and building 15, which 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.
Barbara White: 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
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 of the library. We will obviously give you updates starting from RBC in vitro as we did before mix you should expect to see a key animal data and then starting to dialogue around the potential indications for that.
Barbara White: FDA will review and weigh this endpoint, even though it's now a secondary.
Barbara White: 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 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 in measurement, and its difficulty in using it 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 CRIS itself, including several patient-reported outcomes. I think those will be of interest to them, as will be DMR-SS, a measure of skin, and force vital capacity, a measure of lung.
And I also want to remind Ted you in our audience.
That.
The advantage of doing so isn't only bringing new drugs to the market. We will always always have a limited ability in terms of how many drugs weaken.
Developed 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 Weve. If like these 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 a general overview in barba. Please fill in anything that I've I may have forgotten.
Thank you well.
We think and we plan to from our emerging compounds undergo the initial screen I'll be able to generate probably two candidates that will per year that would undergo subsequent to a more detailed DMP K animal model testing with the goal of having one or two of those actually enter phase one testing.
Maureen Raycroft: Got it. That's helpful. And thank you for taking my question. Thanks, Wally.
Ted Tentoff: Once again, if you would like to ask a question, please press star 1 on your telephone keypad. Our next question comes from Ted Tentoff with Piper Jaffray. Please state your question. Great, thank you very much for the update, and I enjoyed the R&D day very much. 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
Each year.
Starting in.
Oh 2020, so we will move 4001 at the end of this year and our plan would be to at least one additional compound into phase one testing.
Next year and each subsequent year from what we generate ourselves.
Yuval Cohen: Candidate for, you know, 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. Appreciated that you can never really control that. But what do you think the team is capable of doing in terms of generating new candidates like 4001? Thanks.
Great I really appreciate that and thank you for the update.
Our next question comes online of George Zavoico with B. Riley.
Please proceed with your question.
Hi, everyone. Good morning, everyone and thanks for the update already knowledge.
Hi, So I'm again, so clearly you're preparing for commercial launch or with the slew of of hires.
I'm.
Yuval Cohen: Ted, thanks for that question. Oh, sorry, Barbara.
I'm going to ask I wanted to ask about how that plan is going with regard to the number of different indications are you going after scleroderma and direct my side is of course.
Barbara White: 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, we are very, very excited. All eyes are on Lenabisin, appropriately so, with a launch as early as 2021. 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 Lanabis. Lanabis 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, and I think that as we see these compounds come to the fore and we started with just the first group of the library, we will obviously give you updates starting from obviously in vitro as we did before.
First with regard to the CMC are you are you planning ultimately to bring manufacturing in house, which would require you know you.
Much more.
Individualized to personalize it were CMC kind of work.
And is there any.
Overlap with the two diseases or would you require two separate sort of initiatives are with with your personnel was with medical affairs and I'm marketing.
So George Thank you good morning, I'll start with the CMC and then I'll turn it over to Craig.
As we have absolutely no intention of building CMC capacity in house as you know one of the things, we really pride ourselves on he's a very very lean.
I'm very capital efficient model.
We started corbis again, just five years ago.
And our pipeline I think is.
It's 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 comments on Georgia is in terms of the two indications yeah sure. So thanks for the question George So.
Our initial.
Potential indications with being systemic sclerosis, and cystic fibrosis.
With dramatic myositis 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 launching 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 is there is not indicated specifically for systemic sclerosis, and really a sizable commercial potential.
Barbara White: Next, you should expect to see key animal data and then start 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 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 at the early stages of development, and we look around at some of our peers and some of our very successful peers, and one of the things that we've at least concluded is that to become a very successful company in our field, it is really imperative to start building those relationships.
So we believe there is 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 is about 50 knows but also potentially to branch out even into the community with the lift Rheumatologists, who are often making initial an initial diagnosis and then seeing systemic sclerosis patients early in their disease progression before they refer them.
So we believe that it will be able to leverage a lot of those commercial capabilities that we built for example, you thing 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 so that would really be our starting point and then obviously.
Yuval Cohen: You cannot do this on your own. So that was sort of the general overview. Barbara, please fill in anything that I may have forgotten.
Barbara White: Thank you, Yvonne. We think and we plan to, from our emerging compounds that undergo the initial screen, be able to generate probably two candidates per year that would undergo subsequent more detailed DMPK animal model testing with the goal of having one or two of those actually enter phase one testing each year, starting in 2020. So we will move 4,001 at the end of this year, and our plan would be to move at least one additional compound into phase one testing next year and each subsequent year from what we generate ourselves.
There would be significant synergies with a potential launch in dramatic into D'amato myositis, 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 pursuit amount of myositis.
So.
Hopefully that addresses the question thanks George.
Yes that helps with you mentioned rheumatologists and the community level.
For referral do you ultimately see the community rheumatology actually.
Ah diagnosing and taking over treatment or do.
Ted Tentoff: Great, I really appreciate that, and thank you for the... Our next question comes from the line of George Savoico with B. Riley. Please state your question.
Expect most divisions to be referred to Oh, especially.
Right, Yes, no. It's a great question I think one right now I think we're just generating hypotheses around that.
Certainly because of the dearth of current treatment options a lot of a lot of treatment happen has happened is the centers of excellence.
George Savoico: Hi everyone. Good morning, everyone. Thanks for the update. Hi, so clearly you're preparing for commercial launch with the 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 myositis, of course. First, with regard to CMC, are you planning, ultimately, to bring manufacturing in-house, which would require, you know, a much more... individualized or personal, as it were, PMC kind of work? And is there any overlap between the two diseases, or would you require two separate sorts of initiatives with your personnel in medical affairs and marketing?
You know the current again, there's nothing specifically indicated for systemic sclerosis. So it often comes down to a particular specialists treating a particular.
Manifestation of the disease based on organ involvement.
The opportunity, obviously with when Apis and of course, we have to wait to see what the data tell us.
But you know depending on the ultimate benefit risk profile could certainly be very attractive in terms of.
You know in oral option for.
On the colleges 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. The reason referred to those centers of excellence. So certainly an opportunity one that we have to do a lot more work to two.
Yuval Cohen: George, good morning. I'll start with a 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 is certainly a testament to the very rapid progress we've made and the very, very efficient use of capital. So we absolutely have no intention of doing CMC in-house.
Stats, but.
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 et cetera.
You know will will yield.
Hello.
Figure that out in due course, but that's kind of the hypothesis at this point.
Yeah, that's what I was thinking about because it is an oral option because it is an oral drug.
And it's Dave so far and hopefully it'll 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 as I, probably assessing and hopefully something like that or will.
Craig Millions: Craig comments on George's situation in terms of the two indications.
Will evolve in time in due course.
Craig Millions: Thanks for the question, George. Potential indications would be systemic sclerosis and cystic fibrosis, with Dermatomyocyte 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 because there are very few treatment options. In fact, there's none indicated specifically for systemic sclerosis and really a sizable commercial potential. So we believe there's an opportunity to leverage a customer-facing team as well as digital channels first to target those centers of excellence that treat scleroderma specifically. There are about 50 of those, but potentially, they could branch out even into the community with rheumatologists who are often making an initial diagnosis and then seeing systemic sclerosis patients early in their disease progression before they refer them.
With regard to comp yes.
Sorry.
Oh, Oh go ahead Im sorry.
With regard to see outlets question.
This is you know this path has been followed with other drug companies and are using some of those as a model you don't you don't have a.
Precedent for sclerosis in dermatomyositis, but with cystic fibrosis, there's a lot of.
Marketing data and other information you can use are you leveraging any of that.
So I'll I'll, yeah, so I'll I'll take that George Yes, I would say, there's a 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.
With a very focused customer facing team I think probably 20 or so.
Individuals highly highly trained focused on the.
The centers of excellence that treat cystic fibrosis as you mentioned, unlike systemic sclerosis intermodal myositis, there's not a lot of mystery in terms of where the CF patients are who is treating them. It's highly concentrated so really allows for a very efficient.
Craig Millions: So we build that. And we'll be able to leverage a lot of those commercial capabilities that we build. For example, when you think about marketing, market access, commercial operations, all of our CRM-type systems, then to 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 would be able to really leverage the infrastructure that we would have built for systemic sclerosis to then pursue dermatomyositis. So, hopefully...
Model that would combine obviously.
Calling on those centers as well as some mechanism to provide.
Patient services directly to two patients and that would be kind of a model. We would we would look at there.
Okay great.
Thanks very much.
Thank you George.
Just are no further questions in the queue.
I would like to thank everyone for their participation on today's call. You may now disconnect. Your lines. Thank you and have a wonderful day.
Thank you everyone.
Craig Millions: Yeah, that helps. But you mentioned rheumatologists at a community level. Do you ultimately see community rheumatologists actually diagnosing and taking over treatment, or do you... We expect most patients to be referred to a specialist.
Craig Millions: Right. Yeah, no. It's a great question.
Craig Millions: I think one, you know, right now, I think we're just generating hypotheses around that. Certainly because of the lack of current treatment options, a lot of treatment has to happen in the Centers of Excellence. You know, the current situation, 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 Linavitin, obviously, 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 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, or if there's other efficient ways through multi-channel marketing, for example, digital, et cetera, we'll figure that out in due course, but that's kind of the hypothesis at this point.
George Savoico: Yeah, that's what I was thinking about, 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, perhaps for greater benefit. But, as you say, it is a process of testing, and hopefully, something like that will evolve in time, in due course.
George Savoico: More to come, yep.
George Savoico: Sorry?
Craig Millions: I'm sorry.
George Savoico: 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... President for Sclerosis and Dermatitis, but with cystic fibrosis, there's a lot of marketing data and other information you can use. Are you leveraging any of that?
Craig Millions: Yeah, so I'll take that, George. Yes, I would say 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..., 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, and 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.
Craig Millions: Okay, great. Thanks very much.
Operator: Thank you, George. There are no further questions left in the queue. I would like to thank everyone for their participation on today's call. You may now disconnect your lines. Thank you, and have a wonderful day.
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