Q2 2020 Corbus Pharmaceuticals Holdings Inc Earnings Call
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Hello, and welcome to the Corpus Pharmaceuticals second quarter August 6th Twentytwenty earnings Conference call.
Operator: Hello and welcome to the Corbus Pharmaceuticals second quarter August 6th, 2020 earnings conference call. As a reminder, all participants are in a listen-only mode. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Following the formal presentation, there will be a question and answer session. This conference is being recorded at the company's request and will be available on the company's website following the end of the call. I will now turn the conference over to your host, Ted Jenkins, Senior Director, Investor Relations and Corporate Communications. Please go ahead, sir.
As a reminder, all participants are in listen only mode.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
Following the formal presentation, there will be a question and answer recession.
This conference is being recorded at the company's request and will be available on the company's website. Following the end up the call.
I will now I'll turn the conference over to your host Ted Jenkins Senior Director Investor Relations and corporate Communications. Please go ahead Sir.
Thank you Brock good morning, everyone.
Ted Jenkins: Thank you, Brock. Good morning, everyone.
Ted Jenkins: At this time, I'd like to remind our listeners that remarks made during this call may state management's intentions, hopes, beliefs, expectations, or projections for the future. These are forward-looking statements that involve risks and uncertainty. Forelooking statements in this call are made pursuant to the safe harbor provisions of the Federal Securities Law. 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. The 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 my pleasure to turn the call over to you all.
This time I'd like to remind our listeners that remarks made during this call may state management's intentions hopes beliefs expectations or predictions for the future.
Forward looking statements involve risks and uncertainties.
We're 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 corbis, its current expectations and actual results could differ materially as a result, you should not place undue reliance on any forward looking statements.
That could cause actual results to differ materially from those contemplated by such forward looking statements are discussed in the periodic reports corpus filed with Securities and Exchange Commission.
Mr available in the investors section of the company's website and on the Securities Exchange Commission website. We encourage you to do these documents carefully.
Joining me on the called they are Dr. ball Cohen, our Chief Executive officer like the double White, our Chief Medical Officer, and head of research, Sean brand, our Chief Financial Officer, and Craig million, our Chief commercial officer.
That is it's my pleasure to turn the call over to you all.
Yuval Cohen: Thank you, Ted. Good morning, everyone. It is my pleasure to welcome everyone to Corbus Pharmaceuticals' second quarter of 2020 earnings conference call. Our team had a very busy second quarter, and we are on track for what we believe could be a transformative year with multiple anticipated catalysts in the coming months. First, we look forward to top-line data from our recently concluded Phase 3 systemic sclerosis study this summer. These results will be followed by our recently concluded Cystic Fibrosis Phase 2B study results in the third quarter.
Thank you said good morning, everyone. It is my pleasure to welcome everyone to Corbis Pharmaceuticals second quarter of 2020 earnings Conference call.
Our team has had a very busy second quarter. We are on track for what we believe could be a transformative year with multiple anticipated catalysts in the come up.
First we look forward to topline data from our recently concluded they eat that makes the most of the study this summer.
Next these results will be followed by our when he said he concluded it big fibrosis Phase Twob study result in the third quarter.
With these critical data read out now closer than ever we are focusing more and more on preparing the groundwork for any eighth admission and then commercialization following potential approval.
Yuval Cohen: With these critical data readouts now closer than ever, we are focusing more and more on preparing the groundwork for NDA submission and then commercialization following potential FDA approval. At this time, our finances are stronger than ever, having just announced that we've raised additional capital of up to $121 million from a combination of our ATM strategy and a debt financing deal from K2 Health Ventures. This significant capital investment ahead of data gives us the ability to have strategic flexibility following data without the pressure of a financing overhead.
At this time, our finances are stronger than ever.
Having just to now that we've raised additional capital of about $221 million.
From a combination of our E N strategy in a debt financing deal truncate to help get health ventures.
This significant capital investment ahead of data gives us the ability to have strategic flexibility.
Following data without the pressure of the financing overhead.
We are also very pleased to have Dr. George go in Boston.
Yuval Cohen: We are also very pleased to have Dr. George Kolumbawa join us as a new board member, on our side, on our Board of Directors. George's experience growing companies and advancing innovation will be a significant asset to Corbus as we transition from an R&D-only organization to a commercial-stage company with a deep pipeline of novel drug candidates targeting the endocannabinoid system. I will now 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, to be followed by comments from Craig Thank you, Barbara.
Join us as the New Board member.
On our site on our board of directors.
Georges experience growing company than advancing innovation will be a significant asset to corbis as we transition from an R&D only organization to a commercial stage company, where the pipeline a novel drug candidate targeting Endocannabinoid system.
I will now turn the call over to our Chief Medical Officer, and head of research Dr. Barbro white to provide us with an update on our clinical and research programs to be followed by comments from Craig million, our Chief commercial officer.
Thank you Barbara.
Thank you you fall.
Barbara White: Thank you, you all. I would like to start by reviewing the impact of COVID-19 on our clinical program. COVID-19 did not substantially delay last patient, last visit in the Resolve 1 study or the Phase 2b CF study. However, it has slowed time to database lock for the Resolve-1 Phase 2 and the CF-002 Phase 2B studies. Anticipating and responding to the potential negative consequences of COVID-19 on study integrity took priority over other activities that are usually done near the end of a study. In-person access to study staff and data at study sites was essentially shut down for about three months and remains limited. Similarly, physical access of study site staff to their own sites was restricted, and some sites were even closed temporarily.
I would like to start by reviewing the impact of covert 19, our clinical programs.
<unk> 19 did not substantially delay last patient last visit and the resolved one study for the phase two Bcf study.
However, it has slowed time to database lock.
Well the resolved one phase two and the C. F series you were two phase to be studies.
Anticipating and responding to the potential negative consequences of covert 19 on study integrity.
Took priority over other activities that are usually done near the end of a study.
In person access to study staff and data that study sites.
Centrally shut down for about three months and remains limited.
Similarly, physical access a study sites staff to their own sites with restricted.
And some sites even closed temporarily.
These restrictions limited the ability of studies site staff to do in person assessments of subjects and slowed data entry and responses to questions about data.
Barbara White: These restrictions limited the ability of study site staff to do in-person assessments of subjects and slowed data entry and responses to questions about data to adjust for these changes in access to sites and data. We set up and continue to use alternative ways to monitor study data, that is, Remote Data Monitoring and Central Data Monitoring. Combined, these COVID-19-associated limitations have slowed completion of data entry and data cleaning, and hence, database lock, for the systemic sclerosis phase 3 and CF phase 2b studies. None the worse.
To adjust for these changes and access to sites and data.
We set up and continue to use alternative ways to monitor study data.
That is remote data monitoring and central data monitoring.
Combined these covert 19 associated limitations have slowed to completion of data entry and data cleaning and hence database lock.
Well the systemic sclerosis phase three and see if they used to be studies.
Nonetheless.
Barbara White: We are expecting top-line data from the Phase III SSC study soon, to be followed by the CF-002 top-line.
We are expecting topline data.
The phase three efficacy studies soon to be followed by the C F C or zero to topline data.
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In addition, although covert 19 associated limitations at some vendors slowed to start some support a phase one study those studies are now ongoing.
Barbara White: In addition, although COVID-19 associated limitations that some vendors slowed the start of some supportive phase one studies, those studies are now ongoing. The last subject visit in the Resolve 1 Phase 3 study was reported on May 27. We dosed 365 subjects in the double-blind, placebo-controlled part of this study. Of those dosed, 328, or 90 percent, completed the study, and 37, or 10 percent, discontinued the study early, which is lower than the discontinuation rate we assumed at the start of the study. We estimate that the SSC002 study remains greater than 90% powered at P less than or equal to 0.05 for the primary efficacy endpoint, ACR CRISP score at week 52. Data entry for the RESOLVE-1 study is complete, and data cleaning is expected to be completed in the very near term. We are on schedule to report top-line data this summer following the database lock and data analysis.
Last subject visit in the resolved one phase three study wish reported on May 27.
We dose 365 subjects in the double blind placebo controlled part of the study.
Subjects, dosed 328, or 90% completed to study.
And 37 or 10% discontinued the study early.
She is lower than.
And the discontinuation rate, we assumed at the start of the study.
We estimate that the S easy or zero to study remains greater than 90% powered at P less than or equal as your points. You are five for the primary efficacy endpoint a CR Chris score at week 52.
Data entry for the resolved one study is complete and data cleaning is expected to be completed in the very near term.
We are on schedule to report topline data. This summer following database lock on data analyses.
The open label extension of the resolved one phase three study, which is separate from the open label extension of the face to assist you study is ongoing.
Barbara White: The open-label extension of the Resolve 1 Phase 3 study, which is separate from the open-label extension of the Phase 2 SSC study, is ongoing. 98% of eligible subjects, or 320 of 328 subjects, entered the open-label extension, and 33 subjects have already completed at least the first year in the OLE.
98% of eligible subjects or 320 328 subjects entered the open label extension and 33 subjects have already completed at least the first year annually.
Only six subjects are 2% have dropped out of the assess easier is here to open label extension to date, which we find encouraging given the extra burden upcoming for study visits during covert 19.
Barbara White: Only six subjects, or 2%, have dropped out of the SSC002 Open Label Extension to date, which we find encouraging given the extra burden of coming for study visits during COVID-19. Of note, at the three-and-a-half-year mark in the Phase 2 SSC001 Open Label Extension, 25 of 36, or 69% of the subjects were still in the study. This quarter, new analysis showing ACR CRIS score correlates with improvements from baseline and how patients feel and function from the Lanabasem SSC Phase 2 study were presented at the 6th Systemic Sclerosis World E-Congress. In addition, data showing that the biologic effects of lanabasam may include inhibition of inflammasome activation were presented at the ULAR Annual Conference.
Of note at the three and a half year Mark interface to assess C C or zero one open label extension.
25 of 36 or 69% of the subjects were still in the study.
This quarter.
New analysis join a CR, Chris score correlates with improvements from baseline and how patients feel and function from Dolan Alison FSC Phase two study were presented at the six systemic sclerosis World Congress.
In addition data showing that biologic affects of one Abbott. Some may include inhibition enough in Flamel. Some activation were presented at the you are annual conference.
We're also pleased to announce that Hakan pharmaceuticals, our partner in Japan recently obtained orphan drug designation Berlin Abbott some for the treatment of systemic sclerosis from Japan's pharmaceutical and medical devices agency or PMTA.
Barbara White: We are also pleased to announce that Kaken Pharmaceuticals, our partner in Japan, recently obtained Orphan Drug Designation for Linabasin for the Treatment of Systemic Sclerosis from Japan's Pharmaceutical and Medical Devices Agency, or PMDA. Turning to the CF-002 Phase 2B study, the last subject visit was reported on June 22.
Turning to the C F C or zero to face to be study.
Last subject visit was reported on June 22nd.
Barbara White: We had 425 subjects dosed in this study. Of those, 387, or 91%, completed the study, and 36, or 9%, discontinued the study early, which again is a lower discontinuation rate than we had assumed at the start of the study. Power for the CF-002 study remains unchanged at about 80% for event rates of pulmonary exacerbations at 28 weeks, less than or equal to 0.05. Data entry for the CF-002 study is nearly complete, and we are actively cleaning data. Yesterday, we reported that the last patient's first visit in our Determine Phase 3 study of lanabisum indermatomyositis occurred. This study dosed 176 subjects, which exceeded the enrollment target of 150 subjects. To date, only 4 or 2% of subjects have discontinued from the study early. The open-label extension of the study is active, and all eligible subjects have enrolled to date, of note, at the three-year mark in the Phase 2 DM001 Open Label Extension. 16 of 20, or 80%, of subjects were still in the study.
We had 425 subjects dose than this study of those 387 or 91% completed the study.
And 36 or 9% discontinued the study early which again is a lower discontinuation rate than we had assumed at the start of the study.
Power for the CFC or zero to study remains unchanged at about 80% for event rate of pulmonary exacerbations of 28 weeks with P less than or equal to <unk> 0.05.
Data entry for the CFC or zero to study is nearly complete and we are actively cleaning data.
Yesterday, we reported that last patient first visit in our determine phase three study of one absent under MME myositis Kurt.
This study dose to 176 subjects, which exceeds the enrollment target of 150 subjects.
To date, only four or 2% of subjects have discontinued from the study early.
The open label extension of the study is active and all eligible subjects have enrolled to date.
Of note.
At the three year Mark in the face too Damn 001 open label extension.
Tina 20, or 80% of subjects were still in the study.
Yeah, Hi, H. sponsored hundred patient phase two study of one ABA semon systemic lupus erythematosus is ongoing.
Barbara White: The NIH-sponsored, 100-patient Phase II study of linabasam and systemic lupus erythematosus is ongoing. Study enrollment was temporarily halted by the NIH because of COVID-19, but has recently resumed at several sites. Eighty-seven subjects have been enrolled to date, and we are optimistic that enrollment may be complete by the end of the year.
Study enrollment was temporarily halted by the NIH because of covert 19.
But has recently resumed at several flights.
87 subjects have been enrolled to date and we are optimistic that enrollment may be complete by the end of year.
I'm going to speak briefly about several preclinical programs now.
Barbara White: I'm going to speak briefly about several preclinical programs now. CRB4001 is a CB1 inverse agonist that improves metabolic abnormalities and reduces inflammation and fibrosis in non-clinical models of disease. CRB 4001 is undergoing chronic pharmacokinetic studies in primates to measure brain exposure, and results of these studies are expected this year. Our pipeline is growing.
CRB 4001 is the CB, one inverse agonist, which improves metabolic abnormalities and reduces inflammation and fibrosis and nonclinical models of disease.
Your be 4001 is undergoing chronic pharmacokinetic studies in primates to make sure brain exposure.
Results of these studies are expected this year.
Our pipeline is growing.
Barbara White: As you may remember from our last R&D day, CRB-317 is one of our promising CB2 agonists that Corbus has developed in-house. We are pleased to announce that CRB-317... has been selected as our next candidate for development, based on its significant potency and selectivity for CB2 and biologic activity in animal models of inflammation and fibrosis. Non-clinical studies and formulation work to enable an IND submission are underway. We expect CRB 317 to be in Phase 1 safety testing in 2021. We will share information with you at our next R&D day. I will now turn the call over to Craig Millian, who will provide the commercial program update.
As you May remember from our last R&D day, CRP 317 is one of our promising Cbtwo agonist Corbis has developed in house.
We are pleased to announce that CRB threeseventeen.
That's been selected S., our next candidate for development.
Based on its significant potency and selectivity for C b too.
And biologic activity and animal models of inflammation and fibrosis.
Nonclinical studies and formulation work to enable I N D submission are underway.
We expect CRB threeseventeen.
To be in phase, one safety testing and 2021.
We will share information with you at our next R&D day.
I will now turn the call over to Craig million, who will provide the commercial program update.
Thanks, Barbara good morning.
Craig Millian: Thanks, Barbara. Good morning.
Yes, very excited to be moving closer toward topline data you anticipated commercialization of what Addison.
Craig Millian: We're very excited to be moving closer to top-line data and the anticipated commercialization of Linabad. During the second quarter, we continued to effectively execute on our key pre-launch activities. And today I'm going to provide brief updates on the progress we're making to build out our launch team, as well as on our disease education effort. With leadership in place in the key areas of marketing, market access, commercial operations, and medical affairs, we are advancing plans for scaling up our teams to support a successful launch. The first area of focus is implementing our field medical go-to-market model. We are executing a phased approach that will ensure a robust and appropriate field medical presence ahead of launch, with the initial hiring of a small number of medical science liaisons (or MSLs), which would follow positive clinical data.
Over the second quarter, we continue to effectively execute on our key prelaunch activities.
And today Im going to provide brief updates on the progress, we're making to build that ever launched team as well as on or disease education efforts.
With leadership in place into key areas of marketing market access commercial operation and medical Affairs, we are advancing plans for scaling up our teams to support a successful launch.
The first area focus is implementing our field medical go to market model.
We are executing a phased approach that will ensure a robust inappropriate field medical presence ahead of launch with the initial hiring a small number of medical science liaison sport and themselves, which could follow positive clinical data.
The other cells are part of the medical affairs team reporting up to Barbara.
Craig Millian: The MSLs are part of the medical affairs team reporting up to Barbara. They will be experts in scientific and medical information related to the disease states we're studying, as well as our clinical program. MSLs will be responsible for building strong relationships with external clinical and scientific leaders at both the national and regional level. We also plan to begin scaling up other key launch-related areas, including national payer accounts, patient services, and reimbursement. Commercial Technology, Marketing, and Market Analytics
They will be experts in scientific and medical information related to the disease States, we're studying as well as our clinical programs.
EMEA sales will be responsible for building strong relationships with external clinical and scientific leaders at both the national and regional level.
We also plan to begin scaling up other key launch related areas, including national payer accounts.
Patient services in reimbursement.
Commercial technology marketing and market analytics.
Craig Millian: I look forward to providing additional details in future calls as we further build these capabilities following data. Turning briefly to disease education. On our previous call, I highlighted the progress we're making on the rollout of the Total FSC campaign. Earlier this year, we launched this disease education campaign targeted at rheumatologists, and we are continuing to build out and fully leverage this program. The TotalSSC.com website has seen traffic steadily increase month over month, and to date, the website has received more than 19,000 unique visitors.
I look forward to the body additional details in future calls as we further build these capabilities following data.
Turning briefly to disease education.
On our previous call I highlighted the progress were making on the rollout of the total S. C campaign.
Earlier this year, we launched this disease education campaign targeted to Rheumatologists, and we're continuing to build out and fully leverage this program.
The total SFC Dot Com website has ceased traffic steadily increase month over month.
And to date the website has received more than 18000 unique visitors.
Craig Millian: More recently, we expanded our disease education outreach with an email campaign directed to the majority of physicians who treat systemic sclerosis as identified via claims data. We are actively collaborating with systemic sclerosis key opinion leaders to further expand educational subject matter, including videos and other dynamic content, and we plan to have this available on the Total FSC website later in the year. As Barbara mentioned, Corbus had a strong presence at the Virtual Systemic Sclerosis World e-Congress. We fully leveraged the Total SSE campaign at the Corbus virtual booth to drive engagement and to educate on the total burden of systemic sclerosis, the unmet need, and the promise of CB2 agonism. We were pleased to learn from conference organizers that there were 1,300 registered attendees at the meeting, and a large portion visited our booth and engaged with key content. In summary, we continue to make substantial progress ensuring we will be in a position to successfully commercialize linabasam following FDA approval and provide an important treatment option to patients suffering with this debilitating disease. I look forward to continuing to update you on our expanding efforts in the coming months and will now turn the call back over to you all.
More recently, we expanded our disease education outreach with an email campaign directed to the majority of physicians, who treat systemic sclerosis has identified by a claims data.
We are actively collaborating with systemic sclerosis, just key opinion leaders to further expand educational subject matter, including videos and other dynamic content.
We plan to have this available on the total SFC website later in the year.
As far as I mentioned corbis had a strong presence at the virtual systemic sclerosis World. He Congress.
We fully leveraged the total SFC campaign at the Corbis virtual B to drive engagement and to educate on the total burden of systemic sclerosis, the unmet need and the promise of C. B two agonism.
We were pleased to learn from conference organizers that there was 1300 meeting registries.
A large portion visited our be engaged with key content.
In summary, we continue to made substantial progress ensuring we will be in a position to successfully commercialize them out of some following FDA approval.
And to providing important treatment option for patients suffering with this debilitating disease.
I look forward to continuing to update you on or expanding efforts in the coming months and we'll now turn the call back over to evolve.
Thank you Craig [noise].
Yuval Cohen: Thank you, Craig. Thank you, Barbara and Craig.
Sorry.
Thank you Barbara Craig I will now provide an update on our financial position.
Yuval Cohen: I will now provide an update on our financial position. We head towards our data announcements with a strong balance. We recently announced up to $121 million in new capital, comprised of approximately $71 million from our existing ATM and $50 million debt financing facility with K2 Health Ventures, of which $20 million is in the first round. We've also received a $5 million milestone payment from the Cystic Fibrosis Foundation, to whom we are very grateful. We reported $101 million of cash on hand as of July 28, 2020, putting us in a strong financial position and giving us valuable strategic flexibility heading into data. In closing, I would like to reiterate how excited we are for these upcoming milestones. We are on the verge of an inflection. We believe that these upcoming data will change our company, and we are poised to make the transition from an R&D-only organization to the commercial stage. Thank you all for your time and attention this morning. I now turn the call back to the operator, and we'll open the call to questions from our audience.
We headed towards our data announcements with a strong balance sheet, we recently announced up to $121 billion in new capital comprised of approximately 71 million from our existing ATM and $50 million. This financing facilities with K, two health insurers of which 20 million is in.
First tranche.
We've also received a 5 million dollar milestone payments for the cystic fibrosis Foundation to whom we are very grateful.
We recorded $101 million a cash on hand as of July 28, 2020.
Putting us in a strong financial position.
And giving us valuable strategic flexibility heading into data.
In closing I would like to reiterate how excited we are for the upcoming milestones.
We are on the verge of an inflection point, we believe that these upcoming data would change our company and we are poised to make the transition from an R&D only organization to a commercial stage company.
Thank you all 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 our audience.
Thank you we will now begin we would all be conducting a question and answer session. If you would like to be placed in the question Q. Please press star one on your telephone keypad.
Operator: Thank you. We will now begin; 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 poll for questions. Our first question today comes from Brian Abrams of RBC Capital Markets. Please proceed with your question.
A confirmation tone indicate your line is in the question Q.
You May press Star too if you would like to remove your question from the Q.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing star one.
One moment, please while we pull for questions.
Our first question today comes from Brian Abrams of RBC capital markets. Please proceed with your question.
Hi, there good morning, Thanks for taking my questions that congrats on the progress and that really appreciate all the detailed.
Brian Abrams: Hi there. Good morning.
Barbara White: Thanks for taking my questions. I congratulate on the progress and really appreciate all the details on timelines and enrollment across the clinical trials. I guess my first one is on the patient-reported outcome components of CRIS. I guess I'm wondering, coming out of the recent presentation, any sense as to how the FDA or KOLs as well are viewing CRIS overall and regulatory amenability to, I guess, approval of CRIS if the benefits are predicated primarily on the PROs versus trends in MRSS?
All the details on timelines and enrollment across the clinical trials because my first one is on the patient reported outcome components of Chris or I guess I'm wondering you are coming out of the recent presentation any sense as to how the FDA or K wells as well are viewing Chris.
Overall and regulatory Amenability.
Took two I guess to approval on Chris if the if the benefits are predicated primarily on the PR rose.
Versus trends and I'm Rss.
Hi, Brian This is Barbara thanks, Thanks, very much for your question I.
Barbara White: Hi Brian. This is Barbara. Thanks very much for your question. I think, as we've discussed before, based on what has happened in past clinical trials, KOL opinion, in my belief, has swung towards thinking that the change in the Modified Rodnan Skin Score, or MRSS, while a
I think as we've discussed before.
Based on what has happened and past clinical trials.
Okay, well opinion and my belief has swung towards thinking that change in modified broaden and skin score our MRM assess while a.