Q4 2020 Corbus Pharmaceuticals Holdings Inc Earnings Call

Yeah.

[music].

Operator: BF-WATCH TV 2021

Hello, and welcome to the Corvus Pharmaceuticals fourth quarter and year end 'twenty 'twenty earnings Conference call.

Operator: Hello and welcome to the Corbus Pharmaceuticals fourth quarter and year-end 2020 earnings conference call. As a brief reminder, all participants are currently in a listen-only mode. If anyone requires operator assistance during the conference, please press star zero on your telephone keypad. Following the presentation, there will be a question and answer session. Note that this conference call is being recorded at the company's request and will be made available on the company's website following the end of the call. I would now like to turn the call over to your host, Ted Jenkins, Senior Director, Investor Relations and Corporate Communications. Please go ahead, sir.

As a brief reminder.

All participants are currently and on listen only mode.

If anyone requires operator assistance during the conference. Please press star zero on your telephone keypad.

Following the presentation, there will be a question and answer session.

Note that this conference call is being recorded at the company's request and will be made available on the company.

<unk> web site following the end of the call.

I would now like to turn the conference over to your host Ted Jenkins Senior Director Investor Relations and corporate Communications. Please go ahead Sir.

Ted Jenkins: Thank you, Operator, and good morning, everyone. Thank you for joining us today. 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 future projections, forward-looking statements that involve risks and uncertainty. Forward-looking statements and comments 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.

Thank you operator, and good morning, everyone.

For joining us today at this time I'd like to remind our listeners that remarks made during this call.

Companies eight managements intentions hopes beliefs expectations for future projections. These are forward looking statements and involve risks and uncertainties forward looking statements on this call are made pursuant to the safe Harbor provisions of the federal Securities laws.

These forward looking statements are based on <unk> current expectations and actual results could differ materially as a result, you should not place.

Ted Jenkins: As a result, you should not place undue reliance on any forward-looking statements. Some of the factors that could cause actual results to differ materially from those contemplated by such forward-looking statements are discussed in the periodic reports Corbus files with the Securities and Exchange Commission. These documents are available in the Investors section of the company's website and on the Securities and Exchange Commission's website. We encourage you to review these documents carefully. Joining me on the call today are Dr. Yuval Cohen, our Chief Executive Officer; Dr. Barbara White, our Chief Medical Officer and Head of Research; Sean Moran, our Chief Financial Officer; and Craig Millian, our Chief Commercial Officer. With that, it is now my pleasure to turn the call over to Yuval. Thank you, Ted.

Reliance on any forward looking statements some of the factors that could cause actual results to differ materially from these contemplated by such forward looking statements are discussed in the periodic reports Corvus files with Securities and Exchange Commission.

These documents are available on the investors section of the company's website and on the Securities Exchange Commission's website.

Heard you to review these documents carefully.

And joining.

Joining me on the call today are Dr. <unk> Cohen, our Chief Executive Officer, and Dr. Barbara White, our Chief Medical Officer, and head of research, Sean Grant, our Chief Financial Officer, and Craig Millian, Our Chief commercial officer with that it's now my pleasure to turn the call for your vote.

Thank you Ted.

Yuval Cohen: Thank you, Ted. Good morning, and thank you to all of you who joined us this morning. Since we reported clinical data last year, we have made progress on executing our strategic plan I laid out on the last quarter's call. First, we continue to work to maximize the value of Linabes. Second, we are working to move our internal pipeline into clinical testing in 2022. Third, we are actively engaging with potential partners to expand our pipeline. Analyses of preclinical and clinical data show linabasim is an active compound.

Good morning, and thank you to all of you.

Earlier this morning.

Since we reported clinical data last year, we have made progress on executing our strategic plan I laid out on last quarter's call.

First we continue to work to maximize the value of <unk>.

Second we are working to move our internal pipeline into clinical.

Join us thing in 2022.

Third we are actively engaging with potential partners to expand our pipeline.

Analyses of preclinical and clinical data showed in Addison as an active compound.

Yuval Cohen: As such, we believe our Phase III study in dermatomyositis represents a potentially significant inflection point in the coming months. We have executed our previously announced plan to move the primary endpoints from Week 52 to Week 28, and all patients in the studies have now completed the Week 28 visit.

As such we believe our phase III study in dermatomyositis represents.

Nick will take potentially significant inflection point in the coming months.

We have executed our previously announced plan to move the primary endpoint from week 52 week 28.

All patients in the studies have now completed the week 28 visit.

Yuval Cohen: Our top-line data remains on track for the second quarter of this year. The data from this study will shape our path forward on the map. We continue to advance and prioritize our in-house endocannabinoid system targeting aspects, which Barbara will discuss today. We remain in a unique position, being at the forefront of research and development of molecules that target this biology, which has applicability across many potential indications. This pipeline encompasses drug candidates for metabolic disorders.

Topline data remains.

<unk>, Inc track for the second quarter of this year.

The data from this study will shape our path forward on the Madison.

We continue to advance and prioritize our in house and do cannabinoid system targeting assets, which Barbara will discuss today.

We remain in.

On physician being on the forefront of research and development of molecules that target. This biology.

That has applicability across many potential indications.

This pipeline encompasses drug candidates for metabolic disorders, fibrotic diseases and cancer.

Yuval Cohen: We anticipate that lead compounds from these internal programs will start clinical studies in 2022. The third element of our strategy is to expand our pipeline through acquisitions of external assets. We are focusing on biology beyond the endocannabinoid system and new indications that will leverage our expertise and capabilities within immunology. Our ability to advance our internal programs, along with bringing in external assets, depends on Corbus having the necessary human and financial resources.

We anticipate that lead compounds from these internal programs will start clinical studies in 'twenty 'twenty two.

The third element of our strategy is to expand our pipeline through acquisitions of external assets.

We are focusing on biology beyond.

On the Endo cannabinoid system, and new indications that will leverage our expertise and capabilities within immunology.

Our ability to advance our internal programs, along with bringing in external assets.

<unk> on corvus, having the necessary human.

And financial resources.

Yuval Cohen: As we reported this morning, the company's cash position has been significantly strengthened, and now stands at approximately $127 million, a record for Corbus. This capital provides a cash runway into early 2024, based on our current expectations, and gives us an opportunity to expand and diversify our pipeline. We believe we are well positioned to execute on our plan and look forward to the next quarter. I will now turn the call over to Barbara.

As we reported this morning, the company's cash position has been significantly strengthened and now stands at approximately $127 million.

A record for cordis.

This capital provides a cash runway into early 'twenty two.

<unk> for based on our current expectations and gives us an opportunity to expand and diversify our pipeline.

We believe we are well positioned to execute on our plan and look forward to the next quarter.

I will now turn the call over to Barbara.

Sure.

Barbara White: The Phase III Determined Study, which is testing the safety and efficacy of lanabisim in adult patients with dermatomyositis, is progressing on schedule. As you've all said, we amended the protocol to change the timing of the primary efficacy endpoint from week 52 to week 28. As a reminder, the primary efficacy endpoint is the composite ACR-ULAR total improvement score comparing lanabasum 20 mg twice daily and placebo. In this study, lanabasam and placebo are added to stable doses of standard treatments for dematomyositis, including immunosuppressive therapies. All subjects in the determined study have completed their week 28 visit, and most have completed a 28-day safety follow-up visit off study drugs. Top-line results are expected in the second quarter of this year.

Thank you Paul.

The phase III determine study.

Which is casting safety and efficacy of <unk> in adult patients with dermatomyositis is progressing on schedule.

<unk> all said, we amended the protocol to change the timing of the primary efficacy.

The endpoint for week 52, two week 28.

As a reminder.

Primary efficacy endpoint is the composite ACR ULA total improvement score.

Continuing on now listen 20 milligrams twice daily and placebo groups.

In this study will now for some of the placebo are added on to staple doses for standard treatments for demand on my side is including immunosuppressive therapies.

All subjects in the dirt determined study have completed their week 28 visit.

And most have completed a 28 day.

A safety follow up visit off study drug pop.

Topline results are expected in the second quarter of this year.

Barbara White: The outcome of the determined study will inform our decision about next steps in our systemic sclerosis program, forced vital capacity as measured in these dermatomyositis subjects over the course of the study. We note with interest that Roshazak Kemra was approved by the FDA for the treatment of interstitial lung disease in systemic sclerosis recently, despite failing to meet the primary efficacy endpoint in both the Phase 2 and Phase 3 studies The approval appeared to be based on findings of less decline in forced vital capacity in post hoc analyses of subgroups of the systemic sclerosis subjects. We are considering potential implications for the Lenadysen Program, in which less decline in forced vital capacity was also observed in a subgroup of subjects in that study.

The outcome of the determined study.

Inform our decision about next steps in our systemic sclerosis program.

Forced vital capacity.

In measured in eastern Adam outside of subjects over the course of the study.

We note with interest net wells shows that camera was approved by the FDA for the treatment of interstitial lung disease and systemic sclerosis recently.

Despite failing to meet the primary efficacy endpoint.

It's been in both the phase two and phase III study.

The approval appear to be based on findings of less decline in forced vital capacity and post hoc analysis of subgroups of the systemic sclerosis subjects.

We are considering potential implications for the linearity.

Now for some programs.

In which less decline in forced vital capacity was also observed in a subgroup of subjects in that study.

Barbara White: Currently, we are not considering additional studies of linabasim and cystic fibrosis. However, we are working with investigators on post-hoc analyses of the data to better understand pulmonary exacerbations in people with cystic fibrosis who are at high risk for these medically significant events. We want to take this opportunity to reiterate our gratitude to the leadership of the Cystic Fibrosis Foundation, staff at Cystic Fibrosis Foundation Therapeutics Incorporated, all our investigators, and especially all the patients who participated in these studies for their support throughout our two phase two studies in cystic fibrosis. This is an incredible community.

Currently we are not considering additional studies of law NAV with them in cystic fibrosis.

We are working with investigators on poker.

Post hoc analysis of the data to better understand pulmonary exacerbations in people with cystic fibrosis, who are at high risk for these medically significant events.

We wanted to take this opportunity to reiterate our gratitude.

For the leadership with the cystic fibrosis Foundation.

Cystic fibrosis Foundation Therapeutics incorporated all our investigators and especially all the patients who participated in these studies for their support throughout our two phase two studies in cystic fibrosis. This is an incredible community.

Barbara White: The NIH-sponsored and managed 100-patient Phase II study of lanabisim in systemic lupus erythematosus is nearing completion of enrollment, and we anticipate the NIH may release top-line data in the second half of the year. Our internal pipeline is also progressing.

Cash at this IH sponsored and managed 100 patient phase two study of <unk> and systemic lupus erythematosus is nearing completion of enrollment.

We anticipate the NIH may released top line data in the second half for the year.

Our internal.

The on applying is also progressing clinic.

Barbara White: Clinical data about our CB1 inverse agonist and our CB2 agonist programs were presented in January at the New York Academy of Sciences webinar titled, Targeting the Endocannabinoid System to Treat Human Diseases. Cannabinoid receptor type 1, or CB1, is a major regulator of energy in the body. This has been demonstrated in studies with ramanubandh, in which inhibition of CB1 led to weight loss, as well as improvement in fasting glucose, insulin sensitivity, dyslipidemia, and metabolic syndrome.

Clinical data about our CB, one inverse agonist on our CB two agonist programs were presented in January at the New York Academy of Sciences, webinar titled targeting the end of cannabinoid system to treat human diseases.

The cannabinoid receptor type.

One O C. D. One is a major regulator of energy and the body. That's demonstrated in studies with Romano bonds, and which inhibition of C. D. One lead to weight loss as well as improvement in fasting glucose insulin sensitivity dyslipidemia and metabolic syndrome.

Barbara White: CB1 has been shown in animal studies to have reciprocal functional activity with the receptors for the Incretin's Glucose-Dependent Insulinotropic Polypeptide, or GIP, and the glucagon-like peptide 1, or GLP-1. This is of importance because recent data show that GIP, and the GLP-1 receptor agonist, semaglutide and terzepatide, reduce obesity and G.I.P. G.L.P.

Arnold Party being one has been shown in animal studies to have reciprocal functional activities with the receptors for the importance glucose dependent insulinotropic polypeptide or G IP and the glucagon like peptide one or G. L. P. One.

This is.

Portance because recent data showed that J L. P. G. I P. J O P. One receptor agonist semi glu tide and tourists appetite reduce obesity on blood sugar in humans.

In animal studies.

J L P J.

G I P J O P. One receptor.

Barbara White: 1 receptor agonists are reported to have greater metabolic effects when used in combination with CB1 inhibitors than when used as monotherapy. Beneficial effects of the combination of GIP, GLP-1 receptor agonists, and CB-1 inhibitors have been observed on body weight insulin action, dyslipidemia, and hepatic steatosis in Obese Diabetic Mice. With this background, we have applied our proprietary learnings about structure-activity relationships to develop next-generation CB1-inverse agonists that maintain functional metabolic activity while reducing brain levels of those compounds as a potential means to avoid psychoactive adverse events.

Goodness.

On a reported to have greater metabolic effects when used in combination with PD. One inhibitors, then when used as monotherapy.

Beneficial effects on.

The combination of G. I P. J L. P. One receptor agonist and C. D. One inhibitors have been observed.

On body weight fat.

Fat mass.

Insulin action, Dyslipidemia and hepatic Steatosis and.

In obese diabetic mice.

With this background, we have applied our proprietary learnings about structure activity relationships.

To develop.

Generation C D. One inverse agonist that maintain functional metabolic activity, while reducing brain levels of those compounds with the potential need to avoid psychoactive adverse events.

Barbara White: We believe levels of CB1 occupancy in the brain must be kept low to minimize safety concerns about potential adverse events of anxiety, depression, and suicidality that occurred with remodeling treatment, causing it to be withdrawn from the European market, where Bonobont freely crossed the blood-brain barrier, whereas we have identified compounds with levels in the rodent brain with chronic dosing that are less than 10% of the levels in the plasma, and testing to date. Our compounds have shown promising efficacy as monotherapies in a mouse model of diet-induced obesity.

We believe levels of CB, one occupancy in the brain must be kept low.

To minimize safety concerns about potential adverse events of anxiety depression and suicide Ality that occurred with forum on treatment, causing it to be withdrawn from the European market.

For bond bond freely cross the blood brain barrier, whereas we have identified compounds with levels.

Net rodent brain with chronic dosing that are less than 10 per cent of the levels on the plasma.

And testing to date.

Our compounds have shown promising efficacy as monotherapy in a mouse model of diet induced obesity.

Barbara White: We have also observed anti-inflammatory and anti-fibrotic activities of our CB1-inverse agonists that are greater than those seen with the Ramanubandh comparator as well as anti-fibrotic activities in a human liver spheroid model of hepatic fibrosis. We believe the combination of potentially beneficial metabolic effects with inhibition of inflammation and fibrosis may make our CB1-inverse agonists useful in the treatment We plan further testing of these compounds in animal models of obesity, glucose intolerance, diabetic nephropathy, and fibrosis.

We have also observed anti inflammatory.

As an anti fibrotic activities of our CB, one inverse agonist.

Then on that are greater than those seen with the room on about comparator.

Well as anti fibrotic activities, and a human liver spheroid model hepatic fibrosis.

We believe the combination of potentially beneficial net.

Metabolic effects within ambition of inflammation and fibrosis.

They make our CB, one inverse agonist useful in the treatment of disorders, such as diabetic nephropathy diabetic retinopathy or Nash.

We plan further testing of these compounds in animal models of obesity glucose intolerance.

Thick nephropathy on fibrosis.

Barbara White: We also plan to test the metabolic effects of our CB1-inverse agonist, in combination with GLP-1 receptor agonists, in animal models. As you know, we have been developing CB2 agonists for the treatment of inflammatory and fibrotic diseases. The literature reports that CB2 agonists have potential efficacy in cancer through multiple pathways, including effects on cell cycle and signal transduction. Indeed, we have found that some of our own CB2 agonists directly inhibit growth of some lymphoma, breast, colon, non-small cell lung, and glioblastoma tumor cells. These effects appear to be mediated through the induction of apoptosis of tumor cells.

We also plan to test the metabolic effects of our C. D. One inverse agonist in combination with G. L. P. One receptor agonist in animal models.

As you know we have been developing CB two agonist for the treatment of inflammatory.

Our bedroom and fibrotic diseases.

The literature reports that CB, two agonists have potential efficacy in cancer and multiple animal models through multiple pathways, including effects on sales cycle sell cycle and signal transduction.

Indeed, we have found that some of our own CB two agonist.

Mature directly inhibit growth.

Some lymphoma breast colon non small cell lung glioblastoma tumor cells.

Effects appear to be mediated through induction of epitopes this of the tumor cells.

Barbara White: In testing to date, some of our CB2 agonists have other effects that might contribute to anti-tumor activity, including inhibition of TGF-beta signaling pathways and tissue fibrosis. We plan to test these compounds in syngeneic animal models of cancer as monotherapy and in combination with checkpoint inhibitors. We look forward to bringing both CB1 Inverse Ag and CB2 agonist compounds into Phase I human testing in 2022. As you've all mentioned, we plan to expand and diversify our pipeline through business development activities. To be clear,

And testing to date some of our C. B two agonists have other effects.

Might contribute to anti tumor activity, including inhibition of TGF beta signaling pathways and tissue fibrosis.

We plan to test these compounds and send generic animal models of cancer as monotherapy and in combination with checkpoint inhibitors.

Forward to bringing both CB, one inverse agonist and C. B two agonist compounds into phase one human testing in 'twenty 'twenty two.

As you've all mentioned, we plan to expand and diversify our pipeline through business development activities.

To be clear.

Barbara White: We are looking to diversify beyond the endocannabinoid system and beyond Autoimmune and Genetic Diseases. We are looking for best-in-class compounds that target disease pathways that are strongly supported by existing scientific data or even fully validated pathways. We are looking to expand our pipeline with both preclinical and early clinical stage assets. We will prefer external assets whose development will be supported by our existing expertise in immunology. Stay tuned. We look forward to disclosing more details about these programs as they progress at a future R&D day. With that, I'll turn the call back to you all.

We are looking to diversify beyond the endo cannabinoid system.

And beyond autoimmune and genetic diseases.

We are looking for best in class compounds that target disease pathways that are strongly supported by existing scientific data or even fully validated.

We look for ways.

We are looking to expand our pipeline with both preclinical and early clinical stage assets.

We will prefer external assets, whose development will be supported by our existing expertise in immunology.

Stay tuned.

We.

For the power to disclosing more details about these programs as they progress other future R&D day.

With that I'll turn the call back to Yuval.

Yuval Cohen: Thank you, Barbara. I will now provide an update regarding our financial position. Corbus has significantly strengthened its balance sheet. We expect cash on hand of approximately $127 million as of March 15, 2021, to fund operations into the first quarter of 2024, based on our current budget.

Thank you Barbara.

Now I'll provide an update regarding our financial position.

This has significantly strengthened its balance sheet, we expect the cash.

Look for them hand of approximately $127 million as of March 15th 2021 to fund operations into the first quarter of 2024.

Based on our current budget.

Yuval Cohen: This should allow us to complete our dermatomyositis study, move our two internal programs into the clinic next year, and pursue complementary external opportunities without a financing overhang. In closing, we continue to believe that the endocannabinoid system is a key target for the development of therapeutics for the treatment of inflammatory, fibrotic, and metabolic diseases, as well as cancer. We're excited for the completion of our Phase III clinical trials in dermatomyositis, and we also look forward to data from the study of Linibizum in lupus.

This should allow us to complete our dermatomyositis study move.

Move on.

Cash on internal programs into the clinic next year and pursue complementary external opportunities without a financing overhang.

In closing we continue to believe that the Endo cannabinoid system is a key target for the development of therapeutics for the treatment of inflammatory.

He brought it and metabolic diseases.

Well as cancer.

We were excited for the completion of our phase III clinical trials and dermatomyositis this year.

We also look for for the two data from this study other than others.

And lupus.

Yuval Cohen: We are actively advancing our pipeline to focus on those programs that we can deliver at the earliest data inflection point. We have the resources and are committed to bringing in external assets that complement our existing pipeline and expertise. We look forward to updating you on those initiatives in the very near future. With that, I'd like to thank you all for your time and attention and turn it over to the operator for any questions from our listeners today.

We are actively advancing our pipeline to focus on.

Five programs that we can deliver at the earliest theta infliction point.

We have the resources and are committed to bringing in external assets that complement our existing pipeline and expertise.

We look forward to updating you on those initiatives in the very new.

On those.

With that I'd like to thank you all for your time and attention and turn it over to the operator for any questions from our listeners today.

Operator: Thank you. We will now be conducting a question and answer session. If you would like to be placed in the question queue, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star 1. One moment, please, while we pull for questions. Our first question today is from Brian Abrams of RBC Capital Markets. Please proceed with your question.

Thank you we will now be conducting a question and answer session.

If you would like to be placed in the question queue. Please press star one on your telephone keypad.

Near future confirmation tone will indicate your line is on the question queue.

You May press Star two if you would like to remove your question from the queue.

For participants using speaker equipment, it may be necessary to pick up your handset before pressing star one.

One moment, please while we poll for questions.

Or for.

And today is for them.

Brian Abrams of RBC capital markets. Please proceed with your question.

David Situ: Hi, this is David Situ on for Brian. Thanks for taking my questions. I just have a couple, and I'll be quick here.

Hi, This is David on for Brian. Thanks for taking my questions I just have a coffee.

The first one I was just wondering if you could elaborate maybe a little more on a.

David Situ: So the first one, I was just wondering if you could elaborate maybe a little more on maybe how comfortable you're getting towards selecting candidates for both the CB1 and CB2 programs. I know that you mentioned you're going to give more details on a future R&D day, but I guess just given the Academy of Sciences data that you presented, it does look like you're starting to clearly differentiate some of the profiles. And I guess I'm just curious if you can provide any more color on how comfortable you are reaching a profile that's desirable.

Maybe how comfortable.

First question towards selecting candidates for book to see if you want on CVT program for another you mentioned.

We're going for more details on the pitch on the day, but I guess just given the academy of Sciences data. They presented it it doesn't look like you're just starting to clearly differentiate us from the profiles on I guess I'm just curious if you can provide.

Any more color on kind of how comfortable you are reached.

Reaching.

A profile that's desirable on and then my second question is just on cash runway. So it looks like the 127 million net you mentioned just now.

So potentially you know 12 for several quarters.

The other one to 2000 accounted for.

For example, maybe a flat run rate of just from ton mill for us.

David Situ: And then my second question is just on cash runway. So it looks like the $127 million that you mentioned just now should last potentially 12 or so quarters through 1Q 2024, which suggests maybe a flat run rate of just around 10 mil for op-eps per quarter. I guess, could you remind us how that comes down from the 21 million last quarter and if this takes into account anything for entering the clinic with additional molecules in 2022 and beyond? Thanks so much.

Opex for corner I guess could you remind us how that comes down from the 21 mill last quarter and if this takes into account anything for entering the clinic with additional molecules in 'twenty 'twenty two and beyond.

Thanks, so much.

Okay. Thanks, I'll take the first question, which was I think about our level of comfort that we'll be able to reach candidate selection with the C. V. When you force agonists in the CB two agonist I'll, let me start with the CP one inverse agonist.

For Us I think there's just so much data.

That show the metabolic effects of these compounds in animals and in humans, and we've been able to confirm that with some of our candidates as well so I suspect that the ability to show desired metabolic activity is not going to be on issue.

Barbara White: Okay, thanks. I'll take the first question, which is what our level of comfort is that we'll be able to reach candidate selection with the CB1 inverse agonist and the CB2 agonist. Let me start with the CB1 inverse agonist. For us, I think there's just so much data that shows the metabolic effects of these compounds in animals and in humans, and we've been able to confirm that with some of our candidates as well. So, I suspect that the ability to show desired metabolic activity is not going to be an issue.

On the the real question is to do our very.

Mary Beth to minimize the levels of CB, one receptor occupancy on the brain with the compounds and we have spent a lot of time testing a lot of compounds and redesigning compounds in order to be able to do that and at this point based on data that we have with some chronic dosing 20.

Barbara White: The real question is to do our very best to minimize the levels of CB1 receptor occupancy in the brain with the compounds. And we have spent a lot of time testing a lot of compounds and redesigning compounds in order to be able to do that. And at this point, based on data that we have with some chronic dosing, 28-day dosing in mice, we really have several promising compounds. So while those tests are ongoing and we need to get into them in even more detail, I, at this point, am actually quite confident that we're going to get there. And we intend to get there by the end of the year, perhaps before the very end of the year.

Eight day dosing in mice, and we really haven't not a simple several promising compounds.

So while those tests are ongoing and we need to get into them in even more detail.

I at this point I'm actually quite confident that we're going to get there and we.

To get there by the end of the year.

Before the very end of the year. So things are progressing nicely in terms of our ability to understand the pharmacokinetics of these compounds on in the brain as well as to move forward with the metabolic studies, we're especially excited.

We intend on to look for to determining the effects of these compounds in combination.

If some of the G. L. P. One receptor antagonist that are currently being used to treat obesity on or useful in diabetes. So.

Barbara White: So things are progressing nicely in terms of our ability to understand the pharmacokinetics of these compounds in the brain, as well as to move forward with metabolic studies. We're especially excited to look forward to determining the effects of these compounds in combination with some of the GLP-1 receptor antagonists that are currently being used to treat obesity and are useful in diabetes. So, thank you.

Well, we're quite excited about the C D one of them for.

Sided programs for C. P. Two agonist program slightly behind that we have compounds that are have some broad.

Hum ability to inhibit tumor cell growth on we think perhaps the real activity will come when we see them and send generic mouse models, where we can engage the immune system.

Barbara White: We're quite excited about the CB1 Inverse Agonist Program, but the CB2 Agonist Program is slightly behind that. We have compounds that have some broad ability to inhibit tumor cell growth. But we think perhaps the real activity will come when we see them in syngenic mouse models where we can engage the immune system because, as you know, these compounds have some pretty extensive activities in the immune system. So that's where I think we'll see real efficacy.

Because as you know these compounds have some pretty extensive activities in the immune system. So that's where I think we'll see real efficacy and we're looking forward as well to testing on some combination with checkpoint inhibitors, where immuno suppression.

Tends to inhibit the applicability of those compounds so.

So we also anticipate.

Selecting a candidate by the end of the year.

I think it looks good for both of them.

For short in cash Sean Moran fearful.

Barbara White: And we're looking forward as well to testing those in combination with checkpoint inhibitors where immunosuppression tends to inhibit the applicability of those compounds. So we also anticipate selecting a candidate by the end of the year. I think it looks good for both of them. Regarding cash, Sean Moran

So we just completed two pivotal studies very expensive in CF.

And efficacy for those costs were reflected.

Wow.

Here's our burn rate and D. M has just finished up the other thing to keep in mind as we went for a reduction in workforce that really cut our personnel costs for we do project about a 10 million dollar burn on average.

Sean Moran: So regarding cash, Sean Moran, CFO, we just completed two pivotal studies, very expensive in CF and SSC, so those costs were reflected in the last burn rate, and DM has just finished up. The other thing to keep in mind is we went through a reduction in workforce that really cut our personnel costs. So we do project about a $10 million burn on average going forward with our cash, and that will fund the development of our compounds into Phase I studies as well.

Bridge going forward with their cash and that will fund.

Development of our compounds into phase one studies as well.

Yeah.

Got it thanks.

As a reminder, if you would like to ask.

Ask a question. Please press star one on your telephone.

Yeah.

The next question is from Maury Raycroft of Jefferies. Please proceed with your question.

Hi, Hi, good morning, everyone.

Thanks for taking my question so.

First question is on their dermatomyositis study.

I'm just wondering if you could say how many patients have gone on to the open label extension and are still on drug and if you can talk about discontinuation rate in this study two and potentially anything that you're seeing in the open label extension study that you can comment.

Operator: As a reminder, if you would like to ask a question, please press star 1 on your telephone. The next question is from Mari Raycroft of Jefferies. Please proceed with your question.

On at this point.

Sure Maher I think this is Barbara thanks for the question on.

Mari Raycroft: Hi. Good morning, everyone.

On some numbers.

We have had the discontinuation rate of around 8% from the study, which was a bit lower than we had anticipated we have had I think.

Mari Raycroft: Thanks for taking my questions. So, my first question is on the dermatomyositis study. Just wondering if you could say how many patients have gone onto the open label extension and are still on the drug, and if you can talk about the discontinuation rate in this study, too, and potentially anything that you're seeing in the open label extension study that you can comment on at this point.

It's 166 patients complete on the.

The week, 28%, which is now the primary efficacy endpoint.

We anticipate having perhaps about 100 patients give or take a few complete the visit 10 by the time.

Barbara White: Sure, Mari. This is Barbara.

Barbara White: Thanks for the question. Some numbers... We had a discontinuation rate of around 8% from the study, which is a bit lower than we had anticipated. We have had, I think it's 166 patients complete the Week 28 visit, which is now the primary efficacy endpoint. We anticipate having perhaps about 100 patients, give or take a few, complete Visit 10 by the time the study is actually shut down, and we have had Of those that are eligible, 90% of the subjects who have been eligible so far have enrolled in the Open Label Extension. Does that help? Any other numbers?

On the studies actually shut down.

And we have had of those that are eligible 90 per cent of the subjects, who have been eligible so far have enrolled in the open label extension.

Does that help.

Any other numbers.

Yes, that's helpful.

Thank you.

And then the other question was just based on the Actemra approval and you commented a little bit about it on the call, but just wondering if you can provide more on what next specific steps are and potentially even a little bit more on timeline I guess.

What else do you need to do.

In order to see if your SFC data could be sufficient to approach a P. A.

And is it contingent on what you see in the Dermatomyositis study.

So I think Laurie as you know.

Mari Raycroft: No, that's helpful. Yeah, thank you.

Mari Raycroft: Yeah, thank you. And then the other question was just based on the ICTIMRA approval, and you commented a little bit on that on the call, but I'm just wondering if you can provide more on what the next specific steps are, and potentially even a little bit more on the timeline. I guess, what else do you need to do in order to see if your SSC data could be sufficient to approach FDA? And is that contingent on what you see in the dermatomyositis study?

We've found there.

Well on the camera for the treatment of interstitial lung disease, and systemic sclerosis of great interest because that study on that drug had failed.

Had two negative studies phase two into phase III with not meeting the primary endpoint, but they did have I think really encouraging data and for smiles.

Capacity is for understanding that the F. D. I actually requested the date on which certainly don't know that we're not privy to that but I think that that may be the case and then looked at a subset of what wasn't even a secondary on out now system that they first phase two study so it was.

Barbara White: So I think, Mari, as you know, that we found the approval of Actemra for the treatment of interstitial lung disease and systemic sclerosis of great interest because that study, that drug had failed, had two negative studies, a phase two and a phase three, with not meeting the primary endpoints. But they did have, I think, really encouraging data and force vial capacity. It is our understanding that the FDA actually requested the data. We certainly don't know that; we're not privy to that, but think that may be the case.

Have a great interest in a drawing daughter poop under those circumstances, which I think points out the need for more treatments for this.

Very severe autoimmune disease. So it makes us look at our data on a couple of a twice or three or four 'twenty time, because we also saw.

And the effect on them.

Less rig decline in forced vital capacity and the patients on who'd.

Who'd been on stable Immunosuppressants. The other thing about the AR camera data with those patients were not receiving what one would consider it now standard of care in fact, they were on.

Barbara White: And then looked at a subset of what wasn't even a secondary analysis in that first phase two study. So it was of great interest that a drug got approved under those circumstances, which I think points out the need for more treatments for this very severe autoimmune disease. So it makes us look at our data a couple of times, twice or three or four or 20 times, because we also saw an effect and a less decline in poor cytocapacity in the patients who've been on stable immunosuppressants.

Background, immunosuppressants or low doses of corticosteroids.

Steroids, which is really not what the treatment is for interstitial lung disease, whereas our patients were on standard treatment and we were able to also see an impact on force vital Pos passing those people who are on stable doses or had been on it for an established period of time a couple of years.

And so we also see the same kind of.

Improvement, but our numbers are smaller and we want to look for supportive data and we think there can be supportive data that might come from our open label extension people, who switched over to placebo when we look and see how much improvement continues over time is it durable and from the Dermatomyositis study because we are a major unfortunately overcapacity there.

Barbara White: The other thing about the Actemra data was that those patients were not receiving what one would consider now standard of care. In fact, they were on no background immunosuppressants or a low dose of corticosteroids, which is really not what the treatment is for interstitial lung disease.

Barbara White: Whereas our patients were on standard treatment, and we were able to also see an impact on forced vital capacity in those people who are on stable doses or have been on it for an established period of time, a couple of years. And so we also see the same kind of improvement, but our numbers are smaller, and we wanna look for supportive data. And we think there can be supportive data that might come from open-label extensions, people who switched over to placebo, when we look and see how much improvement continues over time. Is it durable?

A smaller percentage of the patients have interstitial lung disease. It's about 38 per cent I believe in our D. On study, but we're gonna be very eager to see what.

Change and forced vital capacity looks like in those patients on linear, but some versus placebo when they've done on stable in history.

So the timelines for doing that will be after we get the D. M data after we get the additional data analysis done then we will.

If we think it's worthwhile it's hard to know if this FDA decision was a one off or is it something or if it signals some sort of change in willingness to consider subset.

Barbara White: And from the dermatomyositis study, because we are measuring forced vital capacity there, a smaller percentage of the patients have interstitial lung disease; it's about 38%, I believe, in our DM study. But we are gonna be very eager to see what Change in Force Vital Capacity looks like in those patients, Lenabisin versus placebo, when they've been on stable immunosuppressive agents. So the timelines for doing that will be after we get the DM data, after we get the additional data analysis done, then we will... see if we think it's worthwhile. It's hard to know if this FDA decision was a one-off or if it signals some sort of change in willingness to consider subset analysis to prove drugs in this rare disease.

[noise] analysis, the approved drug in this rare disease.

Yeah.

Got it that's really helpful perspective, so it sounds like potentially the next update.

On this potential path would be in the second half this year.

I think that's fair by the time, we get the damn data and look for everything else because getting the dam day.

This will be our first priority right now.

Got it okay. Thank you very much for taking my questions.

Thank you we have reached the end of our question and answer session, ladies and gentlemen that concludes today's teleconference and webcast we.

We thank you for your participation.

You may disconnect your lines at this time and have a wonderful day.

[noise].

What's going on.

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Barbara White: Got it. That's a really helpful perspective. So it sounds like potentially the next update on this potential path would be in the second half this year.

Yeah.

[noise].

Barbara White: I think that's fair, by the time we get the DM data and look through everything else, because getting the DM data is going to be our first priority right now.

Hum.

Yeah.

Right.

Yeah.

Yeah.

Mari Raycroft: Got it. Okay. Thank you very much for taking my question.

Yeah.

Hum.

Yeah.

Uh huh.

Yeah.

Okay.

Okay.

Okay.

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

Yeah.

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Yes.

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