Q1 2020 Earnings Call

Greetings and welcome to the Corpus Pharmaceuticals quarterly update conference call. It a webcast at this time all participants are you listen only mode.

Operator: And welcome to the Corbus Pharmaceuticals quarterly update conference call in Web 2.0. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad.

Sure that's recession will follow the formal presentation.

Pretty much acquire operator assistance during the conference. Please press Star Zero Wonder telephone keypad. As a reminder, this conference is being recorded it's now my pleasure to introduce your host Ted Jenkins Senior Director Investor Relations in corporate Communications. Please go ahead Sir.

Operator: As a reminder, this conference is being recorded. It's now my pleasure to introduce your host, Ted Jenkins, Senior Director, Investor Relations and Corporate Communications. Please go ahead, sir.

Thank you Ken Good morning, everyone. At this time I'd like to remind all listeners that remarks made during this call mistake management's intentions hopes beliefs expectations or projections for the future.

Ted Jenkins: Thank you. Thank you, Kevin. These are forward-looking statements that 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's 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 SEC's website.

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 sporting goods 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 any forward looking statements I mean, the factors that could cause actual results could differ materially the most contemplated by such forward looking statements are discussing the credit reports Corpus filed with Securities Exchange Commission.

These documents are available in the Investor section of the company's website and on the Securities Exchange Commission to 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. Yuval Cohen, our Chief Executive Officer; Dr. Barbara White, our Chief Medical Officer and Head of Research; 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 you all. Thank you, Ted.

Joining me on the call today are Dr., you've all Cohen, our Chief Executive Officer, Dr. Barber White, our Chief Medical Officer, and head of research, Sean brand, our Chief Financial Officer, and Craig Knowing our Chief commercial officer with that it's my pleasure to turn the call over do you want.

Thank you Chad good morning, everyone. It is my pleasure to welcome everyone to Corbis Pharmaceuticals.

Dr. Yuval Cohen: Good morning, everyone. It is my pleasure to welcome everyone to Corbus Pharmaceuticals' first quarter 2020 earnings conference call. We had an active first quarter and are on track for an exciting year. We anticipate multiple catalysts and data readouts in the coming months. First, top-line Lemavisim data from the Resolve-1 Phase III study in systemic sclerosis remains on schedule and will be available this summer. These data will be followed by top-line data from our Phase 2 B-limb atlas and study in Cystic Fibrosis, with these critical data readouts now closer than ever. We are focusing more and more on preparing our NDA submission and commercialization following FDA approval. We are also on track with our CRB 4001 Phase 1 study that will start later this year as well as the selection of our next candidate, also scheduled for later this year. I would now like to turn the call over to our Chief Medical Officer and Head of Research, Dr. Barbara White, to provide us with an update on our clinical and research programs. Thank you. Barbara?

First quarter 2020 earnings conference call.

We had an active first quarter and are on track for an exciting year, we anticipate multiple catalyst and data read out in the coming months.

First topline Madison data from the resolved one phase three study in systemic sclerosis remains on schedule and won't be available and will be available. This summer.

These data will be followed by topline data from our seems to be than habits and study in cystic fibrosis.

With these critical data read outs now closer than ever.

We are focusing more and more on preparing our India submission and commercialization following FDA approval.

We are also on track with our CRB 4001 Phase one study that will start later this year as well.

As a selection has our next candidate also scheduled for later this year.

I would now like to turn the call over to our Chief Medical Officer, and head of research talk to Barbara White to provide us with an update on our clinical and research program. Thank you Barbara.

Thank you you have all.

Dr. Barbara White: Thank you, Yuval. To start, we do not anticipate significant delays or impact from COVID-19 on the delivery of top-line data from the ongoing phase 3 systemic sclerosis and phase 2 cystic fibrosis studies. Our staff and the study site staff are committed to completing these studies on time with attention to subject safety and data integrity. Because of COVID-19, Corbus has put in place new ways of working remotely within the company and with study sites, external contractors, consultants, and vendors. We have had virtual meetings with staff at all study sites about how to manage subject safety, efficacy evaluations, and drug supply if subjects cannot have visits at sites. We remain in frequent contact with sites about these issues, data entry, and data monitoring.

To start we do not anticipate significant delays or impact from the coven 19.

On the delivery of topline data from the ongoing phase three systemic sclerosis, and faced you cystic fibrosis studies.

Our staff.

And this study sites staff are committed to completing these studies on time.

With attention to subjects safety and data integrity.

Because of covert 19, corbis has put into place new ways of working remotely.

Within the company and we study sites external contractors consultants and vendors.

We have had virtual meetings with staff at all study sites about how to manage subjects safety efficacy evaluations and drug supply.

Objects cannot have Pacific sites.

We remain in frequent contact with sites about these issues data entry and data monitoring.

Dr. Barbara White: We have implemented remote data monitoring procedures and are implementing central data monitoring for all ongoing clinical trials run by Corbus. Our procedures are consistent with FDA and other health authority recommendations made for the pandemic. We will resume on-site data monitoring for all ongoing clinical trials when it is safe to do so, and travel and site restrictions are lifted. I am pleased to inform you that as of Friday, as a result of these efforts, about 99% of enrolled Phase III systemic sclerosis study subjects and about 96% of Enrolled Phase 2b Cystic Fibrosis Study Subjects have completed double-blind, randomized, placebo-controlled dosing. Each study will have a 28-day safety follow-up period after dosing is complete.

We have implemented remote data monitoring procedures and are implementing central data monitoring for all ongoing clinical trials run by corpus.

Our procedures are consistent with FDA and other health authority recommendations made for the pandemic.

We will resume onsite data monitoring for all ongoing clinical trials when safe to do so and travel insight restrictions are lifted.

I'm pleased to inform you that as of Friday as a result with these efforts.

How about 99%.

Have enrolled phase threes systemic sclerosis study subjects.

And about 96%.

I've been rolled phase to be cystic fibrosis study subjects have completed double blind randomized placebo controlled dosing.

Each study has a 28 day safety follow up period after dosing is complete.

Dr. Barbara White: Of note, participation in the systemic sclerosis phase 3 open label extension remains high. About 97% of eligible subjects to date have enrolled in the Open Label Extension, with a few more patients waiting to enter the Open Label Extension after COVID-19 associated travel restrictions are lifted. Only about 1% of subjects have dropped out of the OLE to date, and some subjects have participated in the Open Label Extension for more than a year. Based on current study progress, we remain on schedule for top-line data for the Phase 3 systemic sclerosis study in summer 2020; the cystic fibrosis data will follow. Our Phase III determined study in dermatomyositis is about 80% enrolled. Enrollment in this study has slowed during COVID-19, but it is still active. We anticipate enrollment will be complete in the third quarter of this year, assuming travel restrictions will ease this summer in countries where we have study sites.

Doesn't note participation in the systemic sclerosis phase three open label extension remains high.

About 97% of eligible subjects to date have enrolled in the open label extension.

With a few more patients waiting to enter the open label extension. After cobot 19 associate of travel restrictions are lifted.

Only about 1% of subjects have dropped out of the only to date and some subjects have participated in the open label extension for more than a year.

Based on current steady progress we remain on schedule for topline data for the phase three systemic sclerosis study in summer Twentytwenty.

Cystic fibrosis data will follow.

Our phase three determined studying dramatic myositis, it's about 80% enrolled.

Enrollment in this study has slowed during cobot, Nike, but do you still active.

We anticipate enrollment will be complete in third quarter. If this year, assuming travel restrictions will ease of this summer in countries, where we have study sites.

Craig Millian: Top-line data are therefore on schedule for 2021, and the open-label extension of this study is also active. Our second drug candidate, CRB 4001, is a cannabinoid receptor type 1 inverse agonist. CRB 4001 is designed to have limited access to the brain, to minimize risk of psychiatric side effects of the type that we're seeing with ramanubandha. CRB 4001 has demonstrated potent effects on Glucose Tolerance, Insulin Sensitivity, Lipid Metabolism, Body Fat, and Hepatic Fat in Animal Models of Disease. Additionally, we have identified additional potential beneficial effects in inflammation and The Phase I study of CRB 4001 remains on schedule to start in the third quarter of this year. The Single Ascending and Multiple Ascending Dose Study will evaluate the safety, tolerability, and pharmacokinetics of CRB4001 in healthy, normal weight, and obese volunteers.

Topline data are therefore on schedule for 2021.

The open label extension of this study is also already active.

Our second drug candidates CRB 4001.

Yes, it can happen like receptor type one inverse agonist.

CRB 4001 is designed to have limited access to the brain.

To minimize risk of psychiatric side effects of the type that we're seeing with from on a box.

CRB 4001 has demonstrated potent effects on glucose tolerance insulin sensitivity.

Lifted metabolism body fat and hepatic fat in animal models with disease.

We have identified additional potential beneficial effects in inflammation and fibrosis assay.

The phase one study of CRB 4001 remains on schedule to start in the third quarter off this year.

The single ascending in multiple ascending dose study will evaluate the safety Tolerability and pharmacokinetics of CRB 4001 in healthy normal weight and obese volunteers.

Additionally work to expand our pipeline is being done by our internal research team up medicinal chemists damn PK specialist toxicologist small berson biologist.

Craig Millian: Additional work to expand our pipeline is being done by our internal research team of medicinal chemists, DMPK specialists, toxicologists, modelers, and biologists, working in concert with external collaborators and vendors. We anticipate selection of our first organically developed CB2 agonist candidate compound within the next few months. I will now turn the call over to Craig Millian to discuss our commercial program update.

Working in concert with external collaborators and vendors.

We anticipate selection of our first organically developed Cbtwo agonist, Canada compound within the next few months.

I will now turn the call over to Craig millions to discuss our commercial program update.

Thank you Barbara and good morning, everyone.

Craig Millian: Thank you, Barbara, and good morning, everyone. We continue to execute on our commercial strategy to be launch-ready ahead of a potential Linabis launch and regulatory approval. As we advance our pre-launch preparations, we're building our commercial capabilities, establishing a deep understanding of the market and needs of the patient, and communicating relevant scientific information in the appropriate manner. Importantly, we have established a talented group of capable leaders to drive a successful launch and have most recently filled key roles on the marketing and medical affairs team. On the last call, I highlighted the robust market access landscape and pay research we completed at the end of last year.

We continue to execute on a commercial strategy to be launch ready ahead of a potential and added some regulatory approval.

As we advance Catsix launch preparations were building out commercial capabilities, establishing a deep understanding of the market and needs of the patient.

And communicating relevant scientific information and the appropriate manner.

Importantly, we have established a talented group of capable leaders to drive and successful launch have most recently filled key roles on the marketing and medical affairs teams.

On the last call I highlighted the robust market access landscaping and research we compete at the end of last year.

Craig Millian: In the first quarter of this year, we conducted additional marker research in the form of a baseline awareness and perception survey with 100 U.S.-based rheumatologists who treat systemic sclerosis. These physicians reported that nearly half of their systemic sclerosis patients suffer from the diffuse cutaneous form of the disease. These are the same type of patients who are in our clinical trials and so are of specific interest to us. Importantly, a vast majority of respondents strongly agreed that there is a high burden of disease, diminished quality of life, and a high mortality rate associated with systemic sclerosis. This recognition of the unmet need is entirely consistent with other market research and KOL insights that we've gathered to date.

In the first quarter. This year, we conducted additional market research in the form a baseline awareness perceptions Jones day.

With 100, U.S. based rheumatologist to treat systemic sclerosis.

These positions reported nearly half of their systemic sclerosis patients suffer from the diffuse cutaneous form a bit disease.

These are the same type of patients who are in our clinical trials and show artist specific interest does.

Importantly, a vast majority of respond and strongly agree that there was a high burden of disease diminished quality of life.

And the high mortality rate associated with systemic sclerosis.

This recognition of the unmet need is entirely consistent with other market research and Caylloma insights that we gathered to date.

Well just research we also established a baseline for awareness any perception of current treatment approaches as well as potential medicines in development.

Craig Millian: Through this research, we also established a baseline for awareness and perception of current treatment approaches, as well as potential medicines in development. For example, on an aided basis, about 50% of respondents were familiar with the cannabinoid receptor type 2 as a potential mechanism for treating systemic sclerosis, and about 30% were familiar with linabasam as a potential future treatment. At this stage, these numbers are encouraging, while also leaving room for growth. On a promising note, of those who were familiar with lanabasum at the time of the survey, about 75% had a positive opinion of lanabasum, while the remainder had a neutral opinion. No respondents indicated a negative opinion.

For example.

On an 80 basis about 50% of respondents were familiar with the canal Benoit receptor tied to as a potential mechanism for trick or treating systemic sclerosis.

And about 30% working failure with wouldn't habits him as a potential future treatment.

At this stage. These numbers are encouraging well also leaving room for growth.

On a promising though of those were familiar with when that is somewhat dependent it's still today about 75% have a positive opinion of let's say, while the remainder have a neutral opinion.

No respondents indicated a negative opinion.

Craig Millian: We'll continue to track these metrics over time and plan to conduct the survey again after we have top-line clinical data later in the year. In addition, we recently engaged Clearview Consulting to conduct a robust and independent commercial assessment for Lenabicin. The results from this exercise further validate the considerable opportunity that exists across the three rare diseases that lanabifim is being studied for in late stage trials. Finally, before turning the call back over to Yuval, I'd like to provide a brief update on how our disease education campaign is progressing. On our last call, I introduced this key initiative, which is providing rheumatologists with relevant scientific information on systemic sclerosis. As a reminder, the insight behind the Totality of Systemic Sclerosis campaign is that SSC is a complex, devastating disease driven by both inflammation and fibrosis. The total burden of systemic sclerosis on patients is considerable, including increased mortality risk and disability. Nevertheless, there remains a significant unmet need as current approaches using immunosuppressive or antifibrotic agents primarily address symptoms or specific organ complications.

We'll continue to track these metrics overtime and plan to conduct the survey again after we have topline clinical data later in the year.

In addition to the awareness and perception study. We also recently engaged clearview consulting to conduct a robust and independent commercial aseptic filling I understand.

The results from this exercise further validate the considerable opportunity that exists across the three rare diseases seven habits and is being studied in late stage trials.

Finally, before turning the call back over to evolve I'd like to provide a brief update on how our disease education campaign is progressing.

On our last call I introduced this key initiative, which is providing rheumatologists with relevant scientific information on systemic sclerosis.

As a reminder of the insights behind the totality of systemic sclerosis campaign.

Is that SFC is a complex devastating disease, driven by both inflammation and fibrosis.

The total burden of systemic sclerosis on patients is considerable including increased mortality risk and disability.

The remains a significant unmet need as current approaches using immunosuppressive or anti fibrotic agents, primarily address symptoms or specific organ complications.

Craig Millian: And importantly, the campaign highlights that cannabinoid receptor type 2 agonism shows promise as a novel approach to address both the inflammation and fibrosis that drives the disease. We are currently attracting viewers to the website TotalSSC.com, which launched in March. There have been early encouraging signs of engagement with the content. For example, approximately 40% of visitors are consuming more than half of the content on the website. This is an encouraging indicator relative to benchmarks suggesting that typically, only 10-20% of visitors consume more than half of the content on a pharmaceutical website.

And importantly, the campaign highlights that can happen annoyed receptor type two agonism shows promise as a novel approach to address both the inflammation and fibrosis that drives the disease.

We are currently attracting viewers to the website total assets Si dot com, which launched in March.

There have been early encouraging signs of engagement with the content.

For example, approximately 40% of visitors are consuming more than half of the content on the web site.

This is an encouraging indicators are relative to benchmarks, suggesting that typically between only 10% to 20% of visitors consumed more than half of the content on a pharmaceutical website.

Dr. Yuval Cohen: Additionally, we've seen strong earned media interest in the campaign, and multiple outlets have published articles or podcasts in recent weeks. These pieces highlight the unmet need in systemic sclerosis and point to the website as a resource. We plan to leverage the campaign throughout Scleroderma Awareness Month in June and at upcoming virtual medical meetings, including the ACR State-of-the-Art Clinical Symposium this month and the Systemic Sclerosis World Congress in July. We are building a solid foundation with these disease education efforts and plan to further scale investment later this year. And, of course, with our commercial leadership team now largely in place, we are purposefully proceeding with all other key elements of launch readiness, which I look forward to updating you on in future calls. Thank you, Craig. Thank you, Barbara. I will now provide a brief update on our financial... The company ended the quarter with $46.6 million in cash and cash equivalents.

Additionally, we've seen strong earned media interest in the campaign.

Multiple outlets have published articles or podcast in recent weeks.

These pieces highlight the unmet need in systemic sclerosis, and point to the web site at the resource.

We plan to leverage the campaign throughout the scleroderma awareness month in June and at upcoming virtual medical meetings, including the HCR state of the yard clinical symposium this month.

And the systemic sclerosis World Congress in July.

We are building a solid foundation with these disease education efforts and plan to further scale investment later this year.

And of course with our commercial leadership team that largely in place. We are purposefully proceeding with all other key elements of launch readiness, which I look forward to updating you on future calls.

Ill now turn the call back over to evolve.

Thank you Craig. Thank you Barbara I will now provide a brief update on our financial position.

The company ended the quarter with $46.6 million in cash and cash equivalent.

Dr. Yuval Cohen: We maintain our guidance. We expect the cash on hand and the remaining $7.5 million in milestone payments from the Cystic Fibrosis Foundation Award to fund our operations into the fourth quarter of 2020. In closing, I want to reiterate how excited we are for the second part of the year. With multiple data readouts and catalysts ahead, including two top-line data readouts for systemic sclerosis and cystic fibrosis, respectively, this will be the most important few months since Corbus was founded six years ago. Let me also take a moment to...

We maintain our guidance and expected cash on hand, and the remaining seven and a half million dollars in milestone payments from the cystic Fibrosis Foundation award to find their operations into the fourth quarter of 2020.

In closing I want to reiterate how excited yard for the second part of this year with multiple data read outs and catalyst ahead, including two topline data read outs for systemic sclerosis, and cystic fibrosis, respectively. This will be the most important several months since corbis a sound it six years ago.

Let me also take a moment to think or staff, our collaborators and be participants in our studies, especially these very challenging times for their continued hard work and dedication we are immensely grateful and hopeful that we will see the end of this crisis very soon.

Dr. Yuval Cohen: staff, our collaborators, and the participants in our studies, especially in these very challenging times for their continued hard work and dedication. We are immensely grateful and hopeful that we will see the end of this crisis very soon.

Dr. Yuval Cohen: With that, I would like to thank all of you for your time and attention this morning. I will now turn the call back to the operator and will open the call to questions from the audience. Thank you.

With that I would like to thank all of you for your time and attention. This morning, I now turn the call back to the operator, and we'll open the call for questions from the audience.

Operator: We'll now be conducting a question and answer session. If you'd like to be placed in the question queue, please press star 1 on your telephone. A confirmation tone will indicate your line is in the question queue.

Thank you will now be conducting your question answer session. If you like to be placed into question could you. Please press star one or telephone keypad, a confirmation Tony <unk>. Your line is another question Q you bet press star to if he'd like to remove your question from the Q for participants using speaker quickly there may be necessary to pick up her headset before.

Operator: You may press star 2 if you'd like to remove your question from the list. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star 1. One moment, please, while we poll for questions. Our first question today is coming from Brian Abrams from RBC Capital Markets. Your line is now live.

Pressing star one one moment, please while we pull for questions.

Our first question today is coming from Brian Abrams from RBC capital markets. Your line is alive.

Bert: Great. Thank you. Good morning. As you mentioned, sorry, this is Bert. I'm here for Brian this morning.

Great. Thank you good morning, Oh so.

Mention sorry, this is bird on for Brian for it.

Bert: Thank you for taking our question. So you mentioned that around 99%, I think, of the patients have been dosed in the RESOLVE-1 study. I just wonder if you could talk a little bit about what data is left to collect in the study, and then

Thank you for taking our question.

So you mentioned that around 99% I pick up the patient dose.

And resolved one study I just wonder if you could talk little bit about what data is loved the color.

In the study and then assuming that there maybe some impact to cover 19 on the data collection.

Bert: Assuming...

Bert: There may be some impact of COVID-19 on data collection. What would be the plan for imputation of any missing data? And what potential impact could that have on the powering of the study?

What would be the plan for for amputation of any missing data.

It's always dark.

Powering the study.

Dr. Barbara White: Thank you.

Thank you.

Oh, Okay. This is Barbara I'll take that question a couple of things to be clear 99% of them has finished.

Dr. Barbara White: Okay, this is Barbara. I'll take that question. A couple of things. To be clear, 99% of them have finished through the end of dosing, and there is yet another 28 day follow-up. So we will need to collect data on the last visit or visits, as well as the 28-day safety follow-up data. We have some more data to collect. However, to date, our data collection and the entry of what we call pages, page entry is also largely complete. It is more than 98% complete.

Through the end of dosing and there is yet another 28 days follow up so we will need to collect.

Data on the last visit or visits as well as to 28 day safety follow up data. So we have some more data to be collected.

However to date, our data collection and the entry of what we call pages page entry is also largely complete it is more than 98% complete. So we're we're pleased with the progress to date. Despite obviously the challenges of covert 19.

Dr. Barbara White: So we're pleased with the progress to date, despite obviously the challenges of COVID-19. We will, when we're done, as we do for all studies, need to make sure every last page of data is entered, and that has been monitored. Because of travel restrictions, we have begun remote data monitoring. That's when sites actually give us data online. We have access to data online. We can review it. And we've done central monitoring, which is where we look over the data ourselves internally, do some additional programming, make sure the data are sensible. And we assume that between the on-site data monitoring that we have had in place and may be able to reinstitute remote monitoring and central monitoring, we will be able to ensure data integrity. We do not anticipate a significant delay because of these challenges. There may be up to a few weeks delay, but at this point, we're not expecting a lot more than that.

We will when we're done as we do for all studies need to make sure every last page of data entry entered and that has been monitored because of travel restrictions. We have begun remote data monitoring that's when side actually give us data.

On line, we have access to data online we review it and we've done central Monterrey, which is where we look over the data ourselves internally just some additional programming make sure the data or sensible and we assume that between the onsite data monitoring that we have had in place and may be able to reinstitute remote.

Well on Iran. In central monitoring, we'll be able to ensure data integrity, we do not anticipate a significant away because of these challenges there may be up to a few weeks delay, but at this point, we're not expecting a lot more than that so we remain on target fourth a data and.

Dr. Barbara White: So we remain on target for the data in summer. In terms of powering, we've also had our statistician look closely at the powering. The statistical analysis program includes approaches for data imputation and, in fact, multiple approaches and sensitivity analysis. Those will be applied where needed because many of the patients had already completed treatment before COVID-19. This will minimize the impact of the need to impute data. And certainly, in the cystic fibrosis study, the pulmonary exacerbation data can all be collected remotely.

So.

In terms of powering we've also had this our statistician look closely at powering we they statistical analysis program includes approaches for day, the imputation in fact multiple approaches.

And sensitivity analysis that was will be applied where needed because many of the patients had already completed before coal with 19.

This will minimize the impact oh, they need to impute data.

And certainly in the cystic fibrosis studied the pulmonary exacerbation data Oh can be collected remotely. So again that that helps there we remain well powered we've enrolled in each study a few more patients than we anticipated dropout rate has been less than we anticipated so again power and remains well.

Dr. Barbara White: So again, that helps there. We remain well powered. We've enrolled in each study a few more patients than we anticipated, and dropout rates have been less than we anticipated. So again, powering remains where we wanted it to be, which is above 90% in the SSC study.

We wanted it to be.

Which is about 90% and yes, I see study.

Maury Raycroft: Excellent. Thank you so much. Thank you. The next question today is coming from Maury Raycroft from Jefferies. Your line is now live. Hi, good morning everyone.

Excellent. Thank you so much.

Thank you next question today's coming for more you recall from Jefferies. Your line is alive.

Hi, Good morning, everyone. Thanks for taking my questions I would ask a endpoint question again, just for the upcoming I see you pivotal data read out. This summer can you guys just talk more about the relationship between Emirates, Ass, and our credit scores and skin softening and so it said that a five point improvement in it.

Maury Raycroft: Thanks for taking my questions. I'm going to ask an end point question again. Just for the upcoming SSE Pivotal data readout this summer, can you guys just talk more about the relationship between MRSS and or CRIS scores and skin softening? And so it said that a five-point improvement is clinically meaningful on MRSS. Do you have a sense of what the bar for meaningfulness is for KLLs and FDA on the CRIS scale?

Clinically meaningful on number of size do you ever sense of what the bar for meaningful message for care walls and at the end of course scale.

So thank you for the question.

Dr. Barbara White: So, thank you for the question. We will determine what the minimal important difference is, which is a change from baseline that subjects say is associated with improvement, and the same thing for physicians. We simply ask the patients if they think they've improved and determine the median score of patients who believe they have improved, and the same thing for physicians who say the patients have improved. So we will have direct data on what that score will be at the end of the study. So I don't really want to speculate on what that answer is at this point, but I think we'll be able to drive that with data when we are there. And we'll, in fact, do the same thing for the MRSS. We'll determine the same kind of minimal important difference within the study for the MRSS, and we'll provide those data both in publications as well as to the regulators.

We we will.

Determine what is minimal important difference, which is a changing from baseline which subjects Jay.

[noise] is associated with improvements in the same thing for us it positions, we simply ask the patients if they think they've improved and determine the median score of patients who believe they have improved in the same thing for position to say the patients have improved so we will have direct data on what that will be at the end of the study. So I don't really want to speculate.

On what that that answer is at this point, but I think we'll be able to <unk> to drive that with data. When we were there and what impact do the same thing I'm 40, m. process with the tremendous <unk> kind of middle important difference within the study for the M. R. S. S.

And we'll provide those data both in publications as well as to the regulators.

Got it okay.

Dr. Barbara White: And so, as a follow-up, I guess for MRSS, then, with that being a secondary endpoint, do you guys have a sense of what different scenarios could look like for the data on that endpoint and how FDA would interpret the data during their review, or is it kind of the same answer as what you just said?

And so for as a follow up I guess for Emerus US then would that being a secondary endpoints or do you guys have is a sense of what different scenarios can look like a poor for the data on that endpoint. It how F.D.A. would interpret the data during the review or is it kind of the same answer is what wages that.

Dr. Barbara White: So, I think the most important thing is to reiterate that the FDA has clearly said that they will look at the totality of the data when they assess things; certainly, we have our primary, and we are quite optimistic that we will see a p-value on this outcome that reflects the totality of the disease. As Craig has said, that's super important when treating these patients, and that's what the ACR CRISP does. The MRSS is the best existing outcome to look at skin thickening, which is a measure of skin fibrosis. It's also important to patients. FDA said to look at the totality of the disease, the totality of the data, and we believe them. There has been no stipulated requirement that we get a p-value on MRSS or that we show a certain difference. At the same time, we certainly expect there to be a treatment effect on MRSS, and we expect to be able to say what the minimal important difference is, the minimal important change is from baseline, and we would expect actually to reach that in the patients who have been treated. We will show all those data to the regulators.

So I think it's I think the most important thing is to reiterate that the FDA has clearly said that they will look at the totality of the data when they assess things certainly we have our primary and well we are quite optimistic that we will see a P value on this outcome that reflects the totality of the Jesus Christ has said that.

That's super important when treating these patients and that's what they see our Christos Dameris S is the best existing outcome to look at skin Sciclone, which has a measure skin fibrosis. It's also important to patients Sta said they'll look at the totality of the disease and we have the totality of the data and we believe.

Well I'm there has been knows if you look requirement that we got a P value on Emerus asked or that we show a certain difference.

The same time, we certainly expect there to be a treatment effect on M.R.S.S. and we expect to be able to say what the minimum important differences and minimal important changes from baseline and we would expect actually to reach that I'm in the patients who have been treated.

Well show all this data to the regulators.

Great Okay.

Craig Millian: Okay, that's helpful. And then just a quick question on the Total SSC website.

That's helpful. And then just a quick question on that total I see web site. Just wondering if there's a lot of information on there.

Craig Millian: Just wondering, there's a lot of information on there. I'm just wondering if you're collecting information from potential patients that could use lanabisome, and can you comment at all on that? I guess it was mentioned that you're getting a lot of hits on the website, and there's a lot of information being consumed, but do you have a sense of, are you collecting patient information and building a patient database from the website? Thanks for the question, Maury.

I'm just wondering if you're collecting a information from potential patients that could easily now this and can you comment at all on that I guess it was mentioned that there you're getting a lot of hits to the website and there's a lot of information being consumed but do you have a sense as are collecting patient information and building a patient database we want.

Right.

Yeah. Thanks, Thanks for the question Maury or actually the website is directed to rheumatologist. So specifically.

Craig Millian: Actually, the website is directed to rheumatologists, so specifically rheumatologists who are treating systemic sclerosis but aren't necessarily kind of the opinion leaders. The opinion leaders are very much aware of the unmet need and are aware of Corbus and the clinical program and the potential for CB2 agonism. So what we really wanted to do was reach out to the broader community of treating physicians who treat systemic sclerosis, not patients, so it's not a patient-directed website. And what we wanted to do was make sure they're aware of the unmet need within the disease and, you know, where the science is leading in terms of potential treatments, including CB2 As part of the evolution of the campaign, there will be more dynamic content added to the site and we will begin to, you know, collect information, start to build a database and begin to have a conversation, you know, with those physicians with obviously the appropriate type of content in a pre-approval context.

Rheumatologists, who are treating systemic sclerosis, but aren't necessarily kind of that the opinion leaders are the opinion leaders are very much aware of the unmet need and are aware of our corbis into clinical program.

And the potential for TV to agonism, so what we really want it could do was reach out to the broader community of treating physicians, who treat systemic sclerosis not patients. So it's not a patient directed website and will be wanted to do is make sure they're aware of.

The unmet need within the disease and you know what were the size of leading in terms of potential treatments, including CV to agonism as part of the evolution of the campaign.

They'll be more.

More dynamic content added to that side and we will begin to collect a information start to build a database and begin to about a conversation you know with those positions Ah with obviously the appropriate the appropriate type of content in a pre approval context. So this is on branded.

Craig Millian: So this is unbranded, it's non-promotional, it's purely disease education but obviously a great opportunity to begin to identify physicians who have an active interest in learning more about systemic sclerosis. So we are intending to start to, you know, build that database and then continue that communication as we head into potentially a launchable product in Abyssin. But no patient information is on the website.

Oh, it's non promotional it's purely disease education, but obviously, a great opportunity to begin to identify physicians, who have inactive interest in learning more about systemic sclerosis. So we are intending to start to build that database and then continue that communication as we head into.

To potentially a launch blunt habits and.

But not no patient information is on the website.

Leland Gershel: Got it. That's helpful. Thanks for taking my question. My next question today is coming from Leland Gershel from Oppenheimer. Your line is now live. Hey, good morning. Thanks for taking my questions. Just one for me. I joined the call a few minutes after it started. Yuval, had you mentioned the number of patients who had completed dosing in the RESOLVE-1 study before the COVID-19 crisis really began to... I'll have that all hit, good morning ladies.

Got it that's helpful. Thanks for taking my questions.

Thank goodness questions raised three from Leland Gershell from Oppenheimer. Your line is alive.

Hey, good morning, Thanks for taking my questions are just one for me I joined the call a few minutes. After the start you've all heard you mentioned the.

A number of patients who had completed dosing in the result, when study before the covert 19 prices really begin to.

Thanks.

Oh, I don't have already live I'll hand, it over to Barbara.

Dr. Barbara White: I actually don't know the absolute number, but the majority of them had.

Hi, Leyland I actually don't know the absolute number the majority of from had and so we.

Dr. Barbara White: And so we... We will be missing a few patients who have efficacy assessments at the very end, but we can impute those. Those subjects have actually had partial assessments, which could be done off-site. We will impute the data that we need to impute. And again, when we've looked at the power calculations and that impact on the study, we've not seen a significant impact, negated in part, as I said, by a bit of over-enrollment and a lower dropout rate than we expected. So we do believe we'll remain on target for both delivery and adequate powering.

We will be missing a few patients who have efficacy efficacy assessments at the very end, but we kind of impute those HM those subjects have actually had partial assessments what could be done off site.

We will improve the data that we need to compute and again when we've looked at Oh.

Looks at the power calculations and that impact on the study weve not seen a significant impact negated in parts as I said by a bit of over enrollment.

And Oh, low dropout rates and we expect and so we do believe will remain.

On targets for both delivery an adequate power.

Leland Gershel: Okay, and then just one follow-up question. Since your initial disclosure of the switch from MRSS to CRISP for the primary endpoint that you intend to have for that phase 3, have you had any further interactions with the agency on that endpoint? Any further color you could provide on their willingness to use that as the primary endpoint for the trial? Thanks.

Okay, and then just one follow up a sincere initial disclosure of the switch from them or access to the Chris for the primary endpoint that you intend to have four.

That phase three have you had any further interactions with the agency on.

That endpoint and he.

Are there.

So you could provide on there.

Willingness to use that as the primary endpoint critical thing.

Dr. Barbara White: So we've not had further interaction. Again, I want to say that they clearly said that the primary efficacy endpoint, that choice, was up to Corbus. Okay, they didn't say we'll think about it and reassess it later. They clearly said at the meeting that the choice is up to Corbus and that they would look at the totality of the data. So I just wanted to emphasize that they've had the revised protocol for quite some time that has that change in efficacy endpoint, and we've had no further input from them about that change. Okay, that's very helpful. Thanks.

So we've not had further interaction, Indiana I want to say that they clearly said that the primary efficacy endpoint that choice with up to corpus. Okay. They didnt say, we'll think about it and that's it later they they clearly said at the meeting that choice, it's up to corpus and that they would look at the totality.

The data so I just just wanted to emphasize that they've had the revised protocol for quite some time, but has that changed on efficacy endpoints and we've had no further in click summed up about that change.

Leland Gershel: Okay, that's very helpful. Thanks very much. Thank you. As a reminder, that's star number one to be placed in the question queue. Our next question today is coming from Christopher Mirai from No More Instant Net. Your line is now live.

Okay. That's very helpful. Thanks very much.

Thank you as a reminder, that star one three play some good question Q. Our next question to lose coming from Christopher Myride from no more is that your line is alive.

Christopher Mirai: Thank you for taking the question and congratulations, Barbara, on all your hard work to get these studies enrolled and moving in the right direction with the. I wanted to first touch upon just a little more clarity regarding how many patients are enrolling in the Open Label Extension. You highlighted on the call that 97% of eligible patients were enrolled in the OLE. Could you just remind us, the qualifier there on eligible, what it means for a patient to be eligible? Then I have a follow-up. Thank you.

Hey, good morning, and thank you for taking the question and congratulations Barbara on all your hard work at these studies.

You know enrolled and given the right direction with it.

Situation anyway, I wanted to two first touch upon just little more clarity regarding how many patients are enrolling in the open label extension you highlighted on the call at 97% of eligible patients were enrolled and they are well even.

Do you just remind US you know the qualifier there on eligible what what does it.

What does it mean for patients to be eligible then oh. Thank you.

Dr. Barbara White: Sure, Chris. First of all, I wanted to say thank you for the kind comment. I do think our staff deserve a shout out. They have gone to extraordinary lengths during this challenging time to keep the studies ongoing as seamlessly as possible, and they've just done a fantastic job. I'm so proud of them. Um, the next question, and I lost it because I was so, so, so committed to taking this.

Sure Chris first of all I want to say, thank you for the kind comments I I do think our staff dessert deserve a shout out they have gone to extraordinary efforts I'm. During this challenging time to keep the studies ongoing to seamlessly as possible and they've just done a fantastic job I'm I'm, so proud of them.

The next question I lost because I was so [laughter] Oh, yeah, Okay Mr. you've got her.

Long dated albeit they see weeks so yeah I know it. It was just understanding you sort of qualified O <unk>.

Christopher Mirai: https://thebusinessprofessor.com

Christopher Mirai: That's what, you know, you can choose an eligible patient. So the original definition of eligible was that you had to complete the dosing in the double blind placebo control part of the study. And now, because we know some subjects can't have that very last visit on site, we've extended that. So, if for any reason they couldn't get the last visit on site, we will still allow them to be eligible. They might have a bit of a pause, but we'll allow them to be eligible. We don't want patients to suffer the consequences of COVID-19 as well.

Well, yes, it's 97% eligible patients could you just remind us what I'm sure you don't want to sell duration.

Sure. The original definition of eligible what's your had to complete the dosing in the double blind placebo control part it part of the study and now because we know some subjects can't have that very last visit onsite weve extended that so if there for any reason I'm they couldn't get.

The last visit onsite, we were still allow them to be eligible they might have a better <unk> pause that will allow them to be eligible we don't give patients too.

Suffer the consequences of cobot 19 as well.

Dr. Barbara White: So to date, it's all of those patients that fall in that category. And we have over, at this point, I don't know the exact number, but I do know it's more than 300,000. And we have over, at this point, I don't know the exact number, but I do know it's more.

To date, it's it's all of those patients the fall in that category and we have [noise] over at this point I don't know what exact number but I do know it's more than 300 patients enrolled.

Okay, Great. That's very helpful. And then just thinking about.

You know the timelines with respect to two data collection and analysis.

Christopher Mirai: at www.pharmaceuticals.com. [Inaudible] Relative to the CF data that you expect to present, is there any chance that the CF data could come before the SSE data? And then, on the SSE top line, I was just curious what you're expecting to share with the street and how you're expecting to share that with the street. Thank you.

Resenting topline results from they assess each study Paul you know maybe that you know and I guess.

The timing of that's on track from our understanding but.

Relative to this you have data that you expect to present is there any chances you update it could come before that as he data and then finally on yes as he topline was just curious what you're expecting to share with the street and how you're expecting to share with the street. Thank you.

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So and well see a.

Dr. Barbara White: So, will the CF data results top line come before the SSC? The answer to that is no. The study is behind the SSC study in terms of where it stands. We have slightly more patients to go through, and the time of their last dose will be later. So we expect the top line CF data to be out more or less a month, give or take a few weeks.

Data results topline come before they assess the answer to that as you know this study is behind the assisting study in terms of a where it stands.

We have slightly more patients to come through the last that the time if their last dose will be later I'm. So we expect the topline CF data to be out.

More or less a month give or take a few weeks later than the SSC data can't say precisely at this point, but he will be later by about that amount of time, when we present topline results. We would certainly expect to present topline efficacy results results Oh.

Dr. Barbara White: then the SSC data. I can't say precisely at this point, but it will be later by about that amount of time. When we present top-line results, we would certainly expect to present top-line efficacy results, results of most, if not all, of the secondaries, and safety information, of course, because of the importance of safety. That's what you should expect.

Most if not all of the secondary.

And safety information of course, because of the importance of safety. That's what you should expect.

Christopher Mirai: Great, very helpful. Thank you, and congrats again.

Great very helpful. Thank you and congrats again.

Dr. Barbara White: Thank you.

Thank you.

Thank you we reach of our question answer session that leaves a gentleman that does conclude today's teleconference. You may disconnect. Your lines is permanent have a wonderful day, we thank you for your participation today.

Operator: Thank you. We've reached the end of our question and answer session. And, ladies and gentlemen, that does conclude today's teleconference. You may disconnect your lines at this time and have a wonderful day. We thank you for your participation today.