Q4 2023 Corvus Pharmaceuticals Inc Earnings Call

Operator: Good afternoon, everyone. Thank you for standing by. And welcome to the Corvus Pharmaceuticals fourth quarter and full year 2023 business update. At this time, all participants are listening only. Later we will conduct a question and answer session. It is now my pleasure to turn the call over to Zach Kubow of Real Health. Go ahead. Thank you, operator, and good afternoon, everyone.

Good afternoon, everyone. Thank you for standing by and welcome to the Corvus Pharmaceuticals fourth quarter and full year 2023 business update and financial results Conference call.

At this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time.

It is now my pleasure to turn the call over to Zac Kubota of real chemistry. Please go ahead Sir.

Zack Kubow: Thank you operator, and good afternoon, everyone.

Zack Kubow: Thank you for joining us for the Corvus Pharmaceuticals fourth quarter and full year 2023 business update and financial results conference call. On the call to discuss the results and business updates are Richard Miller, Chief Executive Officer; and Leiv Lea, Chief Financial Officer. Jeff Arcara, Chief Business Officer, and Ben Jones, Senior Vice President of Regulatory and Pharmaceutical Affairs. The executive team will open the call with some prepared remarks, followed by a question and answer period. I would like to remind everyone that comments made by management today and answers to questions will include forward-looking statements. Forward-looking statements are based on estimates and assumptions as of today and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied by those statements.

Zack Kubow: Thank you for joining us for the Corvus Pharmaceuticals fourth quarter and full year 2023 business update and financial results Conference call.

Zack Kubow: On the call to discuss the results and business updates are Richard Miller, Chief Executive Officer Lately, Chief Financial Officer.

Zack Kubow: Our current Chief business Officer, and Ben Jones, Senior Vice President of regulatory pharmaceutical Sciences.

Zack Kubow: The executive team will open the call with some prepared remarks, followed by a question and answer period.

Zack Kubow: I would like to remind everyone that comments made by management today.

Zack Kubow: Two questions will include forward.

Zack Kubow: Yeah.

Zack Kubow: Forward looking statements are based on estimates and assumptions as of today and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied by those statements.

Zack Kubow: Including the risks and uncertainties described in Corvus's annual report on Form 10-K, which was filed today with the SEC, and other filings the company makes with the SEC.

Zack Kubow: The risks and uncertainties described in <unk> annual report on Form 10-K, which was filed today with the SEC and other filings the company makes with the SEC from time to.

Leiv Lea: The company undertakes no obligation to publicly update or revise any forward-looking statements except as required. With that, I'd like to turn the call over to Leif. Thank you, Zach. I will begin with a quick overview of our fourth quarter and full year 2023 financials and then turn the call over to Richard for a business update. Research and development expenses in the fourth quarter 2023 totaled $4 million compared to $4.1 million for the same period in 2022. R&D expenses for the full year 2023 totaled $16.5 million compared to $24.5 million for the full year 2022.

Zack Kubow: The company undertakes no obligation to publicly update or revise any forward looking statements.

Zack Kubow: Acquire.

Speaker Change: Yeah, I'd like to turn the call over to lately.

Lately: Thank you Zack I will begin with a quick overview of our fourth quarter and full year 2023 financials, and then turn the call over to Richard for a business update.

Lately: Research and development expenses in the fourth quarter of 2023 totaled $4 million compared to $4 $1 million for the same period in 2020 to R&D expenses for the full year 2023 totaled $16 $5 million compared to $24 5 million for the full year 2022.

Leiv Lea: The net loss for the fourth quarter of 2023 was $6.7 million, including a $1.4 million non-cash loss related to Angel Pharmaceuticals, our partner in China. This compares to a net loss of $9.8 million for the same period in 2022, which included a $4.6 million non-cash loss related to Angel. The net loss for the full year 2023 was $27 million, including a $5.3 million non-cash loss related to Angel, compared to a net loss of $41.3 million, including a $10 million non-cash loss related to Angel for the full year 2022. Total stock compensation expense for the fourth quarter and full year 2023 was $0.6 million and $2.1 million, respectively, compared to $0.6 million and $2.7 million in the same periods in

Richard A. Miller: The net loss for the fourth quarter, 2023, with $6 $7 million, including a $1.4 million noncash loss related to Angel pharmaceuticals, our partner in China.

Richard A. Miller: This compares to a net loss of $9 $8 million for the same period in 2022, which included a $4 $6 million noncash loss related to the Haynesville pharmaceuticals.

Richard A. Miller: Net loss for the full year, 2023 was $27 million, including a $5.3 million noncash loss related to angel compared to a net loss of $41 $3 million, including a $10 million noncash loss related to angel for the full year 2022.

Richard A. Miller: Total stock compensation expense for the fourth quarter and full year 2023 points.

Richard A. Miller: $6 million and $2 $1 million, respectively, compared to five 6 million in $2.7 million for the same periods in 2022.

Richard A. Miller: As of December 31, 2023, Corvus had cash, cash equivalents, and marketable securities totaling $27.1 million as compared to $42.3 million at December 31, 2022. I will now turn the call over to Richard, who will discuss our clinical progress and elaborate on our strategy and plan. Thank you, Leiv, and good afternoon, everyone. Thank you for joining us today on our Business Update Call. Corvus has become a pioneer in the research and development of ITK inhibition as a new therapeutic modality to benefit patients with a diverse range of diseases. We have demonstrated that selective inhibition of this target leads to significant biological effects that could lead to new treatments for cancer and immune disease. In 2024, we are focused on two key value drivers to further confirm and advance this opportunity. First,

Richard A. Miller: As of December 31st 2023 quarters had cash cash equivalents in marketable securities totaled totaling $27 $1 million as compared to $42 $3 million at December 31, 2022.

Richard A. Miller: I'll now turn the call over to Richard who will discuss our clinical progress and elaborate on our strategy and plans.

Richard A. Miller: Thank you Leif and good afternoon, everyone. Thank you for joining us today for our business update call.

Richard A. Miller: Cortez has become a pioneer in the research and development of ITK inhibition as a new therapeutic modality to benefit patients with a diverse range of diseases. We have demonstrated that selective inhibition of this target leads to significant biologic effects that could lead to new.

Richard A. Miller: New treatments for cancer and immune diseases.

Richard A. Miller: In 2024, we are focused on two key value drivers to further confirm and advance this opportunity first begin patient enrollment in a registrational phase III trial of so called Internet for patients with relapsed P. T C L well peripheral T cell lymphomas.

Richard A. Miller: Begin patient enrollment in a registrational phase 3 trial of Socolitinib for patients with relapsed PTCL, or peripheral T-cell lymphomas, an indication with no fully FDA-approved therapies and significant unmet need. And second, begin patient enrollment in a placebo-controlled phase 1 trial of Socolitinib for patients with moderate to severe atopic dermatitis, which is expected to generate the first clinical data for We believe Corvus is positioned to build value in the near term with significant upcoming clinical milestones for socolitinib in oncology and immune diseases, further strengthening our ongoing business development, which is concentrated on partnering opportunities for ITK inhibition. Recently, published data demonstrated the potential role of ITK inhibition in a broad range of indications, and we have expanded our capabilities and approach to business development with the appointment of Jeff Arcara as Chief Business Officer Jeff will be presenting his views and strategy in a moment.

Richard A. Miller: An indication with no fully F D. A approved therapies and significant unmet need and second begin patient enrollment in a placebo controlled phase one trial of so-called nib for patients with moderate to severe atopic dermatitis, which is expect.

Richard A. Miller: To generate the first clinical data for ITK inhibition foreign immune disease before the end of Dear.

Richard A. Miller: We believe corvus is positioned to build value in the near term with significant upcoming clinical milestones for socal it made in oncology and immune diseases.

Richard A. Miller: Further strengthening our ongoing business development, which is concentrated on partnering opportunities for ITK inhibition.

Richard A. Miller: Recently published data demonstrated the potential role of ITK and a broad range of indications and we have expanded our capabilities and our approach to business development with the appointment of Jeff Archera as Chief business Officer.

Jeffrey Michael Jones: Jeff will be presenting his views and strategy in a moment.

Richard A. Miller: I will now provide further details on our two priorities for the year and our other programs, starting with Socolitinib for PTCL. We plan to begin patient enrollment in our Socolitinib Registrational Phase III Clinical Trial for PTCL in the third quarter of 2024. The data from our Phase 1 trial continues to evolve with longer follow-up of treated patients. For example, in the most recent data cutoff from January 2024, we found that a patient with previously reported partial responses of approximately 80% target lesion reduction after nine weeks of therapy subsequently converted to a complete response at 18 weeks due to continued tumor response. This patient, who remains on therapy, had relapsed extranodal NK T-cell lymphoma involving the nasopharynx and represents the fourth complete response out of 21 phase 3 eligible patients in the trial.

Speaker Change: I will now provide further details on our two priorities for the year and our other programs starting the socal at Nib four P. T C L.

Speaker Change: We plan to begin patient enrollment in our so-called Registrational phase III clinical trial in relapsed P. T C. L. In the third quarter of 2024.

Speaker Change: The data from our phase one trial continues to evolve with longer follow up of treated patients in.

Speaker Change: In the most recent data cut off from January 'twenty 'twenty four we found that a patient with previously reported partial response of approximately 80% target lesion reduction after nine weeks of therapy subsequently converted to a complete response at 18 weeks due to continued two movies.

Speaker Change: Sponsor.

Speaker Change: This patient who remains on therapy had relapsed extra normal NK and T cell lymphoma involving the nasopharynx and represents the fourth complete response, and if 21 phase three eligible patients in the trial.

Richard A. Miller: The objective response rate, or ORR, for the phase three eligible patients in the phase one trial remains at seven out of 21 patients, with four CRs and three PRs, or 33%. Although not studied head-to-head, the ORR, complete response rate, disease control rate, progression-free survival, and overall survival for this group compare favorably to the results seen with bolinostat or pralatrexate, which are the standard chemotherapies for PTCL and that we will be comparing against in a phase 3 trial. These agents received accelerated approval in the United States, but no definitive trial has been conducted for either. The median PFS, progression-free survival for our patients, and the primary endpoint for our phase three trial remains at 6.2 months, which is substantially better than reported for the standard age group. Regarding our interactions with FDA, we reached agreement on the final study protocol. And in February, they granted socolitinib orphan drug designation for the treatment of T cell lymphoma.

Speaker Change: The objective response rate or O R. R.

Speaker Change: These three eligible patients in the phase one trial remains at seven out of 21 patients with four see ours and three P ours or 33%.

Speaker Change: Although not studied head to head the O R or complete response rate disease control rate progression free survival and overall survival for this group compares favorably to the results seen with Belinda stat, or probably Trek C, which are the standard chemotherapy for P. T C L and that we will.

Speaker Change: Be comparing against in a phase III trial.

These agents received accelerated approval in the United States, but no definitive trial has been conducted for either.

Speaker Change: The median PFS progression free survival for our patients and the primary endpoint for our phase III trial remains at $6 two months, which is substantially better than reported for the standard agents.

Speaker Change: Regarding our interactions with FDA, we reached alignment on the final study protocol and then February they granted so call it near the orphan drug designation for the treatment of T cell lymphomas.

Richard A. Miller: This is an important milestone that reinforces the unmet need for new therapies for these patients given that existing drugs provide limited efficacy and are associated with significant toxicity. In fact, current NCCN guidelines for relapsed refractory PTCL recommend that patients enter an experimental clinical trial as the preferred treatment for second-line therapy. We are already working with or are in advanced discussions with a number of leading centers in the United States and Canada. We anticipate that about 40 centers will participate in the trial.

This is an important milestone that reinforces the unmet need for new therapies for these patients given the existing drugs provides limited efficacy and are associated with significant toxicity.

Speaker Change: In fact current N C C N guidelines for relapsed refractory P. T C. L recommend that patients enter an experimental clinical trial as the preferred treatment for second line therapy.

Speaker Change: We are already working with or are in advanced discussions with a number of leading centers in the United States and Canada. We anticipate about 40 centers will participate in the trial. The vast majority will be in the U S.

Richard A. Miller: The vast majority will be in the U.S. Our second priority is Socolitinib for atopic dermatitis, the first immune disease indication we are exploring. Our plans to move into a clinical trial are supported by our preclinical work, including using Socolitinib to successfully treat spontaneous K9 atopic dermatitis. We are on track to initiate a Phase 1 trial in April. We plan to enroll 64 patients with moderate to severe atopic dermatitis that has progressed on at least one prior therapy. The study will be randomized, placebo-controlled, and blinded to patients and the treating physician. There will be four sequentially enrolled cohorts of 16 patients, with patients in each cohort being randomized three to one to different dosing regimens of socolitinib or placebo administered for 28 days. The primary endpoint is safety and tolerability, and efficacy will be measured using the Investigator Global Assessment and the Clinically Validated Measurement of Improvement in Eczema Area and Severity Index, also known as EASI. It should be noted that while the atopic dermatitis trial is double blind, the patient and doctor are blinded, but the company is not blinded.

Speaker Change: Our second priority is socal at nib for atopic dermatitis, the first immune disease indication we are exploring.

Speaker Change: Our plans to move into a clinical trial are supported by our preclinical work, including using so-called witness to successfully treat spontaneous canine atopic dermatitis.

Speaker Change: We are on track to initiate a phase one trial in April.

Speaker Change: We plan to enroll 64 patients with moderate to severe atopic dermatitis that has progressed on at least one prior therapy.

Speaker Change: The study will be randomized placebo controlled and blinded to patients and their treating physician.

Speaker Change: There will be four sequentially enroll cohorts of 16 patients with patients in each cohort being randomized three to one two different dosing regimens of so-called waiting it or placebo administered for 28 days.

Speaker Change: The primary endpoint is safety and Tolerability and efficacy will be measured using investigator global assessment and the clinically validated measurement of improvement in eczema area and severity index also known as easy E E. A S I.

Speaker Change: It should be noted that while the atopic dermatitis trial is double blind patient and Doctor are blinded, but the company is not blinded we plan to evaluate the data in an ongoing manner as successive cohorts of patients complete enrollment.

Richard A. Miller: We plan to evaluate the data in an ongoing manner as successive cohorts of patients complete enrollment. Based on the anticipated enrollment and follow-up timelines, we believe data from the initial cohorts will be available before the end of 2024, with study completion in early 2025. We are planning to conduct a solid tumor trial in relapsed renal cell cancer but are prioritizing initiation of the PTCL and atopic dermatitis trial. Our plans to move into a clinical trial are supported by our preclinical work and independent academic confirmation led by a team from Erasmus University in Rotterdam. The trial was planned to be conducted in partnership with investigators at the Kidney Cancer Research Consortium. The clinical and preclinical results we have seen with Socolitinib have motivated us to search for additional analogs of ITK inhibitors.

Speaker Change: Based on the anticipated enrollment and follow up timelines, we believe data from the initial cohorts will be available before the end of 'twenty 'twenty four with study completion in early 2025.

Speaker Change: We are planning to conduct a solid tumor trial in relapsed renal cell cancer, but are prioritizing initiation of the T. T C L and atopic dermatitis trials.

Speaker Change: Our plans to move into a clinical trial are supported by our preclinical work and independent academic confirmation led by a team from Erasmus University in Rotterdam.

Speaker Change: The trial was planned to be conducted in partnership with investigators at the kidney cancer Research consortium.

Speaker Change: The clinical and preclinical results, we have seen with Socal at Nib has motivated us to search for additional analogs of ITK inhibitors.

Richard A. Miller: In February, we presented data at the Keystone Symposia on Systemic Autoimmune and Autoinflammatory Diseases that included the first description of our next generation ITK inhibitors, which are designed to deliver precise T-cell modulation that is optimized for specific immunology indications. Given the broad potential of ITK inhibition in inflammatory and immune-mediated diseases, we seek to partner with biotech or pharma companies that have established development and commercialization capabilities that match with In order to accelerate our business development activities, in February, we appointed Jeff Arcara as Chief Business Officer.

Speaker Change: In February we presented data at the Keystone symposia on systemic autoimmune and auto inflammatory diseases.

Speaker Change: That included the first description of our next generation ITK inhibitors, which are designed to deliver precise T cell modulation that is optimized for specific immunology indications.

Speaker Change: Given the broad potential of ITK inhibition in inflammatory and immune mediated diseases, we seek to partner with biotech or pharma companies that have established development and commercialization capabilities that match with the various opportunities.

Speaker Change: In order to accelerate our business development activities in February we appointed Jeff Our Cara as Chief business Officer.

Jeffrey Michael Jones: He joins Corvus with more than 30 years of commercial experience in the biopharmaceutical industry, including broad functional experience across commercial development, corporate development, product licensing and partnering, and corporate strategy. I will now pass the call to Jeff to comment briefly on our business development initiatives. Thank you, Richard, and good afternoon, everyone.

Speaker Change: He joins corvus with more than 30 years of commercial experience in the biopharmaceutical industry, including broad functional experience across commercial development corporate development product licensing and partnering and corporate strategy.

Speaker Change: I will now pass the call to Jeff to comment to comment briefly on our business development initiatives Jeff.

Speaker Change: Yeah.

Jeff: Thank you Richard and good afternoon, everyone.

Jeffrey Michael Jones: I am very excited to join the Corvus team and to advance the development of a very promising pipeline. In cancer, Corvus is focusing on areas of high unmet need with a novel target and with significant commercial potential. The opportunity to join Corvus at this time was very appealing, with a number of potential milestones and key inflection points for the company over the next 6-12 months, including the start of our Phase III trial of socolitinib for relapsed PTCL, which is addressing an indication with significant unmet need and provides the opportunity to bring an important new treatment option to patients and to create value for Corvus. From the commercial perspective, To give a sense of the magnitude of the opportunity, consider these factors.

Jeff: I am very excited to join the chorus team to advance the development of a very promising pipeline.

Jeff: In cancer Corvus is focusing in areas of high unmet need with a novel target and with significant commercial potential.

Jeff: The opportunities joined Corvus at this time was very appealing with a number of potential milestones and key inflection points for the company over the next six to 12 months, including the start of our phase III trial for.

Jeff: For relapsed P T C L.

Jeff: Which is addressing an indication with significant unmet need and provides the opportunity to bring an important new treatment option to patients.

Jeff: Create value for Corvus.

From the commercial perspective, if approved it will be the only fully FDA approved treatment for relapsed P. T C L.

Jeff: To give a sense for the magnitude of the opportunity consider these factors.

Jeffrey Michael Jones: PTCL has a very high unmet need, with a very low survival rate of under 20% at 5 years, so there is a desperate need for new and effective therapy. It is estimated that there are 70,000 cases of PTCL globally, with current pricing for treatments in the U.S. ranging from $200,000 up to $600,000 per year.

Jeff: P. T C. L has a very high unmet need with a very low survival rate of under 20% at five years. So there is a desperate need for new and effective therapies.

Jeff: It is estimated that there are 70000 cases, a P. T C. L globally with current pricing for treatments in the U S ranging from 200000 up to 600000 per year.

Jeffrey Michael Jones: Soqualitnib represents a near-term commercial opportunity with our planned phase three trial protocol intended to enroll 150 patients. The market for drugs to treat hematologic malignancies is large, at approximately $55 billion, and is projected to grow to $90 billion by 2028. For purposes of benchmarking, global sales of Etceteris, an anti-CD30 drug conjugate, were $1.6 million in 2023, with estimated sales of approximately $558 million in patients with non-Hodgkin's lymphoma, primarily in patients with anaplastic T-cell lymphoma, a subset of PTCL, accounting for about 15 to 20% of cases. Together, these factors make the PTCL opportunity substantial More broadly, we view PTCL as an entry point with numerous potential ways to expand the opportunity and to help more patients with solid tumors and immune diseases. Given all this, we believe Socolate Nib and our next-generation ITK inhibitors can be an attractive opportunity for partners, giving you a unique mechanism of action.

So call. It nib represents a near term commercial opportunity with our planned phase III trial protocol intended to enroll 150 patients.

The market for drugs to treat hematologic malignancies is large at approximately 55 billion and is projected to grow to $90 billion by 2028.

Jeff: For purposes of benchmarking global sales of ADCETRIS and anti CD 30 drug conjugate were $1 6 billion in 2023 with estimated sales of approximately $558 million in patients with non Hodgkin's lymphomas.

Jeff: Primarily in patients with anaplastic T cell lymphoma.

Jeff: <unk> set a P T C L accounting for about 15% to 20% of cases.

Jeff: Together these factors make the P T cell opportunity substantial free novel effective treatment.

Jeff: As is seen with other disease modifying therapies in the hematology space.

Jeff: More broadly we view PTC, all as an entry point with numerous potential ways to expand the opportunity.

Jeff: And to help more patients with solid tumors and immune diseases.

Jeff: Given all this we believe sokol at Nib and our next generation ITK inhibitors can be an attractive opportunity for partners, giving you the unique mechanism of action.

Jeffrey Michael Jones: Human Safety Data with Socolate Nib from our Phase 1 lymphoma trial, for large and diverse market opportunities in oncology and immunology, and our strong intellectual property position with issued Composition of Matter patents for Sokal Ignit, extending out to November 2037, not including likely extension. With that, our preferred partnering strategy is to find partners with development and commercialization expertise in immune disease, as well as to seek regional partnerships in onc We have seen increasing momentum and partnering interest since the announcement of our Phase 3 registration trial in the third quarter of 2023 and recent publications on the activity of Socolitinib in preclinical models of cancer and immune diseases. I will now turn the call back to Richard. Thank you, Jeff.

Jeff: Human safety data with Socal isn't there from our phase one lymphoma trial.

Jeff: The large and diverse market opportunities in oncology and immunology.

Jeff: And our strong intellectual property position with issued composition of matter patents for Socal IBM extending out to November 2037, not.

Jeff: Not including likely extensions.

Jeff: With that our preferred partnering strategy is to find partners with development and commercialization expertise in immune disease.

Jeff: As well as to seek regional partnerships in oncology.

We have seen increasing momentum in partnering interest since the announcement of our phase III registration trial in the third quarter of 2023.

Jeff: In recent publications on the activity of Socal at Nib, and preclinical models of cancer and immune diseases.

Jeff: I will now turn the call back to Richard.

Richard A. Miller: Thank you Jeff.

Richard A. Miller: Turning to our partner-led programs, the Kidney Cancer Research Consortium is currently enrolling patients in a phase 2 portion of a phase 1B2 clinical trial evaluating sifradinib, our adenosine A2A receptor inhibitor, as a potential first-line therapy for metastatic renal cell cancer in combination with ipilimumab and nivolumab. The trial is expected to enroll up to Based on current timelines, we anticipate initial interim data in the first half of 2024.

Richard A. Miller: Turning to our partner led programs the kidney cancer Research consortium is currently enrolling patients in a phase II portion of the phase one two clinical trial evaluating <unk> for admins or a dentist in a to a receptor inhibitor as a potential first line therapy for metastatic renal cell cancer in combination.

Richard A. Miller: But they'd be rumor mab and knowing that the clinical trial is expected to enroll up to 60 patients and there are currently about 25 patients enrolled.

Based on current timelines, we anticipate initial interim data in the first half of 2024.

Richard A. Miller: Encouragingly as we enroll more patients we continue to see that the deep response rate exceeds our 32% benchmark based on 14 Evaluable patients that have received at least one follow up assessment up from eight evaluable patients at our Q3 call.

Richard A. Miller: Encouragingly, as we enroll more patients, we continue to see that the deep response rate exceeds our 32% benchmark based on 14 evaluable patients that have received at least one follow-up assessment, up from 8 evaluable patients at our Q3 call. Recall, the deep response rate is complete response plus partial responses that exceed 50% tumor volume reduction. This endpoint has been shown by others to predict prolonged progression-free survival, and it is 32% with ipilimumab and nivolumab. For our anti-CD73 antibody, mupedolamab, our partner, Angel Pharmaceuticals, is continuing to enroll patients in a phase 1, 1B clinical trial in China with mupedolamab alone and together with pembrolizumab in patients with non-small cell lung cancer and head and neck squamous cell cancer.

Richard A. Miller: Recall deep response rate is complete response, plus plus partial responses that exceed 50% tumor volume reduction. This endpoint has been shown by others to predict prolonged progression free survival and it is 32% with it would be aluminum AD and the vote on that.

Richard A. Miller: For our anti CD 73 antibody moved the Dol, a mab or partner Angel Pharmaceuticals is continuing to enroll patients in a phase <unk> clinical trial in China with Mubadala Mab alone and together with him Burleson Mab in patients with non small cell lung cancer, and head and neck squamous cell cancers.

Richard A. Miller: Summarizing the outlook for 2024, our current cash allows us to achieve near term milestones, including starting our Registrational phase III clinical trial of so-called Nib in P. T C. L generating interim data from early cohorts of the so-called mid phase one atopic dermatitis.

Richard A. Miller: Summarizing the outlook for 2024, our current cache allows us to achieve near-term milestones, including starting our registrational phase three clinical trial of socolitinib in PTCL, generating interim data from early cohorts of the socolitinib phase one atopic dermatitis clinical trial, and reporting interim data with sifiradmin and renal cell cancer in the first half of 2024. Our intent is to leverage these near-term milestones and achievements as we seek additional funding and partnerships for our ITK inhibitors in immunology and oncology, as well as our other novel programs, including the A2A receptor antagonist, Ciforadenib. We look forward to providing updates on our programs in the coming quarter.

Richard A. Miller: This clinical trial and reporting interim data with sypher adamant in renal cell cancer in the first half of 'twenty 'twenty four.

Richard A. Miller: Our intent is to leverage these near term milestones and achievements as we seek additional funding in partnerships for our ITK inhibitors in immunology and oncology as well as our other novel programs, including the <unk> receptor antagonist Sephora then it.

Richard A. Miller: We look forward to providing updates on our programs in the coming quarters.

Speaker Change: I will now turn the call over to the operator for a question and answer period.

Speaker Change: Thanks, operator.

Speaker Change: Thank you, we'll now conduct our question and answer session. If you would like to ask a question. Please press star one on your telephone keypad.

Operator: I will now turn the call over to the operator for a question and answer period. Thank you. Thank you. We will now conduct our questions. If you would like to ask a question, please press star 1. A confirmation tone will indicate that you're live. Maypress the star key followed by the number two.

Speaker Change: A confirmation tone will indicate that your line is in the question queue.

Speaker Change: You May press the Star key followed by the number 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 the star keys.

Speaker Change: Please while we poll for questions.

Operator: And our first question comes from Greg Savanovich of Zuho Security. Hi, this is Gerry Alford-Gregg, and it's taking our question... Maybe two from us. Initially, to start off with on the phase three circuit of trial initiation, can you kind speak to what's kind of preventing the start of that trial and have there been any adjustments to the protocol since? I do have a follow-up. There have been no changes or adjustments to the protocol.

Speaker Change: And our first question comes from Greg Savannah, which with Mizuho Securities. Please state your questions.

Speaker Change: Hi, This is Jerry all for Greg that's taking our questions on 82 from us.

Jerry: To start off with all the phase III.

Jerry: Trial initiation, so you kind of speak to what kind of gating. The start of that trial and has there been any adjustments to the protocol since I do have a follow up.

Speaker Change: Theres been no changes or adjustments to the protocol a we've been in complete agreement with FDA on the design statistics and.

Richard A. Miller: We've been in complete agreement with FDA on the design, statistics, and other parameters of the trial. Nothing's changed in that regard. Our Phase I data continues to improve as we have longer follow-up. We're... in the process now of finalizing contracts with the various centers, and there's really no gating items other than the usual administrative things. Gotcha, that's super helpful. And then I have a question for you, Jeff.

Speaker Change: And other our other parameters of the trial nothing's changed in that regard.

Speaker Change: Our phase one data continues to improve as we have longer follow up where.

Speaker Change: In the process now of finalizing contracts with the various centers and Theres really no gating items other than the usual administrative things.

Speaker Change: Got you that's Super helpful. And then a question for you just so you just speak to that to a range of pricing and PTC L. Can you kind of speak a little more onto I guess, how caucuses thinking about.

Jeffrey Michael Jones: So you spoke to a range of pricing in PTCO. Can you kind of speak a little more about where Corvus is thinking about where you fall on that range or that's a range of a scale in terms of pricing? Yeah, thanks. I guess in terms of pricing, you know, obviously, we look at analogs and what the current market is charging in terms of these areas.

Speaker Change: Where do you fall in that range or less.

Speaker Change: A regular scale pricing.

Speaker Change: Okay.

Speaker Change: Yeah, Thanks, and I guess in terms of pricing you know obviously, we look at analogs and what the current market is charging in terms of these areas.

Jeffrey Michael Jones: I think, you know, you take into account the size of the patient population that you're going after, but more importantly, you know, the pricing is really going to be dictated by the size of the unmet medical need, which we know is very large in PTCL, as well as the product profile that we present, so the safety and efficacy data that we have. So I think, you know, obviously, we're looking at analogs at this point in time, but ultimately, the final price will be set once we get the final data and, you know, do some testing with payers on the value proposition. I got it.

Speaker Change: If you take into account the size of the patient population that you're going after.

Speaker Change: But more importantly, the pricing is really going to be dictated on the size of the unmet medical need which we know is very large in P. T C. L. As well as you know the product profile that would present, so the safety and efficacy data that we have so I think you know obviously, we're looking at analogs at this point in time, but ultimately the final price will be set once we get the final data.

Speaker Change: And you know.

Speaker Change: Do some testing with payers on the value proposition.

Operator: Thanks for taking our questions and congrats on the quarter. Thank you. Jeff Jones with.

Speaker Change: Got it thanks for taking my questions and congrats on the quarter.

Speaker Change: Thank you. Our next question comes from Jeff Jones with Oppenheimer. Please state your question.

Operator: Hi, guys, and thanks for taking the question. I guess two for me. Can you speak to the confirmed versus unconfirmed outcomes in the PTCL study with the additional CR now? And just to clarify, how many of those are confirmed versus unconfirmed? They're all confirmed.

Jeffrey Michael Jones: Hi, guys. Thanks for taking the question I guess two for me.

Jeffrey Michael Jones: Can you speak to the confirmed versus unconfirmed.

Jeffrey Michael Jones: Reported outcomes and the R. A.

Jeffrey Michael Jones: P T C L study.

Jeffrey Michael Jones: With the additional CR now and just.

Jeffrey Michael Jones: Just to clarify how many of those are confirmed versus unconfirmed and then were all confirmed.

Richard A. Miller: Okay. Yeah. Thank you. Yeah.

Speaker Change: They're all coming from Okay. Yeah. Thank you, yeah, and Jeff I might also add that usually in relapsed disease. We don't most clinicians don't really talk about confirmed and unconfirmed that's more appropriate in a frontline therapy in relapsed disease, especially in this disease people with such a short time.

Richard A. Miller: And Jeff, I might also add that usually in relapsed disease, most clinicians don't really talk about confirmed and unconfirmed. That's more appropriate in frontline therapy. In relapsed disease, especially in this disease, people live such a short time that in half your cases, it's difficult to even get people beyond a few months. So, but all of our responses are.

Speaker Change: It's half year cases, it's difficult to even get people beyond a few months.

Speaker Change: So, but all of our responses are confirmed parse.

Richard A. Miller: Partial impact. The swimmer plot you're showing looks like there are some patients who are still quite early in treatment. And so it almost looks like you're still enrolling patients in that study. So I guess, are you still enrolling patients in that phase one study? And would you be able to perhaps roll those patients over to phase three? We are not enrolling new patients in the Phase I study.

Speaker Change: Partial in the country.

The swimmer plot, you're showing it looks like there are some patients who are still quite early in treatment and so it almost looks like you are still enrolling patients in that study.

Speaker Change: So I guess argue still enrolling patients in that phase one study and would you be able to perhaps roll those patients over to the phase III.

Speaker Change: We are not enrolling new patients in the phase one study.

Richard A. Miller: The patients that are shown in the swimmers and waterfalls, and some of them are continuing on therapy, will be followed, of course, and continued on therapy until they progress. But there are no new patients being enrolled in Phase I. We're focusing our centers now.

The patients that are shown on the swimmers and waterfalls and some and some of them are continuing on therapy will be followed of course and continued on therapy until they progress, but theres no new patients being enrolled in the in the phase one we're focusing our centers now many of the centers who participated in the phase one are.

Operator: Many of the centers who participated in the Phase I trial are participating in the Phase III trial, so we've got those guys now focused on the Phase III trial. Okay, thanks. I'll jump back into the queue. All right. Hi, this is Liang Cheng from Roger.

Speaker Change: Operating in the phase III.

Speaker Change: So we've got those guys are now focused on the phase III trial.

Speaker Change: Okay. Thanks, I'll jump back into the queue.

Roger Song: Our next question comes from Roger song with Jefferies. Please state your question.

Roger Song: Hi, This is the downtown office about yourself.

Operator: So, thank you for taking our questions. I think we have two questions from us. I think the first one is about socolitinib, you know, the updated phase one data. So, for the, you know, the five patients with tumor reductions that did not meet the criteria of PR, how long were they on treatment? And then for the two that are continued, how long have they been on treatment? We're going to have to call it quits

Roger Song: Thank you for taking our questions I think two questions from US I think first one also collecting it.

Roger Song: You know the update of the phase one data so for the.

Roger Song: You know the five patients with tumor reductions that did not meet your criteria.

PR: PR, but how long worthy on the treatment burden for the two that are continue.

PR: I believe the novel treatment.

Speaker Change: Then I have a follow up thank you.

Speaker Change: For the.

Operator: All right. For those that didn't, that is, the first question had to do with those who have not reached the criteria for PR, how many are still, how long are they still on treatment? So if you look at the swimmer, that would be, One is, which, by the way, you can do yourself, is five months.

Speaker Change: Alright.

Okay.

For those that didn't.

Speaker Change: That are the first question has to do with for those who have not reached the criteria for PR. How many are still how long are they still on treatment.

Speaker Change: So if you look at the swimmer.

Speaker Change: That would be.

Speaker Change: One is which by the way you can do yourself is five months one is.

Richard A. Miller: One is about six or six months old. Another one is seven or eight months old. Okay, and the other ones have been PR. So that's my quick look at the swimmer.

Speaker Change: About six or six months.

Speaker Change: Another one is seven or eight months.

Okay and the other ones that had been Prs. So that's that's my quick look at the swimmer and the second part of your question was what.

Operator: And the second part of your question was, what? So for the two, that it continues treatment, so yeah. They continue treatment, patients continue treatment until they progress, or they have some sort of safety issue, but that's not happening. Sure. Okay. Is that clear? Maybe moving on.

Speaker Change: So over the two that are continuously on the treatment. So yeah, I guess you know.

Speaker Change: We continue on to treatment patients continue on treatment until they progress.

Speaker Change: Or.

Speaker Change: Or do they have some sort of a safety issue, but that's not not happened.

Speaker Change: Sure, Okay, exactly maybe moved out.

Richard A. Miller: Yeah. Yeah. I think, you know, my second question is about the phase one study in atypical dermatitis. So the patients are required to fill at least one prior. So any specific requirements on that? I didn't quite hear the end of your question.

Speaker Change: Yeah, Yeah, I think my second question is about the phase one study.

Speaker Change: But dermatitis. So are the patients are required to sell at least one prior so I mean, our requirements on that.

Speaker Change: I didn't quite hear the end of your.

Richard A. Miller: Patients are required to have failed one prior topical or systemic therapy, they're required to have moderate to severe atopic dermatitis, and they're required to have failed their prior therapy. Does that answer your question? Yeah, yeah.

Speaker Change: Patients are required to have failed one prior topical or systemic therapy.

Speaker Change: They are required to have moderate to severe atopic dermatitis, they're requiring to be.

Speaker Change: Failing their prior therapy.

Speaker Change: Yeah.

Speaker Change: Does that answer your question.

Yes, yes, okay.

Operator: Okay, thank you. That's all for now. Thank you for the question. Our next question... Hi there, this is Rosemary on behalf of Li.

Speaker Change: Okay. Thank you that's all from us.

Speaker Change: Thank you I'll take the question.

Speaker Change: Our next question comes from Lee <unk> with Cantor Fitzgerald. Please state your question.

Lee: Hi, there this is rosemary unfriendly. Thanks, so much for taking the question maybe firstly could you reiterate the benchmark for the relapsed refractory <unk>, yeah, what you're hoping to see that there was some interference in the colors I didn't catch that and then I do have a follow up question.

Operator: Thanks so much for taking our question. Maybe firstly, could you reiterate the benchmarks for the relapse refractory PPCL, what you're hoping to see? There was some interference on the call earlier, so I didn't catch that.

Richard A. Miller: And then I do have a follow-up. So prolatrexate and bilinostat are currently the standard agents for relapsed peripheral T-cell lymphoma. Those agents received accelerated approval approximately 15 years ago, and the companies never did the confirmatory trial.

Lee: I'm, so proud of trackside and Belinda stat are currently.

Lee: The standard agents for relapsed peripheral T cell lymphoma.

Lee: Those agents received accelerated approval approximately 15 years ago and the company's never did the confirmatory trials. So there is no currently fully F. D. A approved drug for relapsed P. T. C. L. Prowler treks, eight and Blurriness that are basically chemotherapy drugs splinter status.

Richard A. Miller: So there is no currently fully FDA-approved drug for relapsed PTCL. Pralotrexate and bilinostat are basically chemotherapy drugs. Bilinostat is an HDAC inhibitor, and pralotrexate is a folate antagonist.

Lee: H JAK inhibitor pellet Trek say it as a full eight antagonist both of those drugs suffered from the usual chemotherapy toxicities, which are neutropenia thrombocytopenia anemia, probably trek say it suffers from an additional tox.

Richard A. Miller: Both of those drugs suffer from the usual chemotherapy toxicities, which are neutropenia, thrombocytopenia, and anemia. Pralotrexate suffers from an additional toxicity, mucositis. The response, those patients, the approval of those drugs was based on single-arm phase II studies that enrolled, oh, somewhere between 100 and 120 patients. The response rate was about 25%.

Lee: Toxicity.

Lee: Scientists.

Lee: The response those study those patients the approval for the of those drugs was based on single arm Phase II study has been enrolled.

Lee: Somewhere between 100 and 120 patients.

The response rate was about 25%.

Richard A. Miller: The PFS, progression-free survival, was, in the case of bilinostat, I believe it was 1.6 months. And in the case of pralotrexate, it was around three months, if my memory is correct. We have a slide about this on the slide presentation on our website.

Lee: The PFS progression free survival was in the case of billing is that I believe it was 1.6 months and then the case of a pallet trucks eight it was around three months. If if my memory is correct. We have a slide about this up on slide presentation on our website.

Speaker Change: So are we.

Richard A. Miller: So we see a 33% response, 33.3% response rate, with more than half being CR. The CR rate in ours is about double the 25% or so response rate with Pralotrexin and Bolinistat, about 10% with CRs. And in our responders, most of the responders are CRs, albeit a small number.

Speaker Change: We see a 33% response 33, 3% response rate with more than half being see ours.

Speaker Change: See our rate in ours is about double of that of the 25% or so response rate with prowler trusting in Berlin is that about 10% with Crs.

Speaker Change: In our responders most of them most of the responders are see ours, albeit a small number so crs are very important in hematology and especially in the lymphoma world.

Richard A. Miller: So CRs are very important in hematology and especially in the lymphoma world. The progression-free survival rate in our arms is 6.2 months, which is substantially better than the 1.6 and 3.0 months I mentioned earlier. So we, our study of, just to go on, because I think I know where you're headed, the, our study design, the statistical design, is to enroll 150 patients, 75 in each arm, standard of care versus socolitinib, 75 in each arm, as I mentioned. We have about 89-90% power to see an improvement from about three and a half months to five and a half months, which is our target. Okay, thank you so much.

Speaker Change: The.

Speaker Change: Progression free survival in our hands is $6 two months, which is substantially better than the $1 six and 3.0 months I mentioned earlier.

Speaker Change: So we hit our study of just to go on because I think I know where your heads.

Speaker Change: Our study design the statistical design is to enroll 150 patients 75 in each arm standard of care versus <unk> 75 in each arm as I mentioned.

Speaker Change: We.

Speaker Change: The power, we have about 80, 990% power to.

Speaker Change: To see an improvement from about three and a half months to five and a half months, which is our target.

Okay. Thank you so much yes, thanks for the a really thorough answer and then I just have a quick question on atopic dermatitis. So for the data that we may get later this year do you have any anticipation around like the nature of that data like how many patients how many doses are.

Richard A. Miller: Yes, thanks for the really thorough answer. And then I just have a quick question on atopic dermatitis. So for the data that we may get later this year, do you have any anticipation about the nature of that data? How many patients? How many doses? Or is it just too early to tell?

Speaker Change: Is it just too early to tell.

Richard A. Miller: Thanks. No, no. We have a very good estimation of that. Okay. So...

Speaker Change: No no we have very good very good estimation of that Oh, okay. So.

Richard A. Miller: So, first of all, we know a lot about the dosing of this drug already since we've been evaluating it in patients with lymphoma. We know a lot about the pharmacokinetics, the occupancy of the target, the safety, et cetera. So we're going to be studying four cohorts of patients that are enrolled sequentially. So we start with, let's say, the low-dose cohort, which in our case is 100 milligrams BID. 200 milligrams BID is our dose in the lymphoma studies and in the proposed phase three. So 100 milligrams BID will enroll 16 patients in a three-to-one randomization where 12 will receive. Socolitinib, and the other four get placebo. Then we go to the next dose regimen, which is 200 milligrams once a day, because we think that once-a-day dosing will be effective, and we think it's more convenient, of course.

Speaker Change: So first of all.

Speaker Change: We know a lot about the dosing of this drug already since we've been evaluating it in patients with lymphoma, we know a lot about the pharmacokinetics the occupancy of the target the safety et cetera.

Speaker Change: So we're going to be studying four cohorts of patients that are enrolled sequentially. So we start with let's say the low dose cohort, which in our cases 100 milligrams B I D 200 milligrams. The ideas are dosing the lymphoma studies and in the proposed phase III, So 100 milligrams B I.

Speaker Change: D will.

Speaker Change: We will enroll <unk> patients in a three to one randomization, where 12, we'll get.

Speaker Change: So call it in it and the other four get placebo.

Speaker Change: Then then we go to the next dose regimen, which is 200 milligrams once a day.

Speaker Change: Because we think that once a day dosing will be effective and we think it's more convenient and of course.

Richard A. Miller: So, same thing, 16 patients go in there, again, 3-to-1 randomization, 12 get socolitinib, 4 get the placebo, and then we go to the third cohort, which is 200 milligrams twice a day, the same regimen that we're using in lymphoma. Same idea, 12 patients get the drug, 4 get the placebo, again, randomized, and then the final cohort would be 400 milligrams once Now, the reason that we're studying those cohorts is that at 200 milligrams, you get complete occupancy of the receptor; 100 gives you pretty good occupancy, but it's not complete, but probably good enough to cause some biological effect. So I would not be surprised if we see some effect even at the lowest dose regimen. So, as I mentioned earlier, the doctor and the patient are both blinded. The company is not.

Speaker Change: So the same thing 16 patients go in there again three to one randomization 12 get the so-called witness for get the placebo and then we go to then there's a third cohort where that which is 200 milligrams twice a day the same regimen that we're using in lymphoma.

Speaker Change: Same same idea 12 patients get the drug forget the placebo again randomized and then the final cohort would be 400 milligrams. Once a day now the reason that we're studying those cohorts is that we know that at 200 milligrams you get complete occupancy of the receptor.

Speaker Change: 100 gives you pretty good occupancy, but not it's not complete but probably good enough to cause some biologic effect.

So I would not be surprised if we see some effect at.

Speaker Change: At the even at the lowest dose regimen.

Speaker Change: So as I mentioned earlier, the Doctor and the patient are blinded. The company is not so we can look at the data and we have a data monitoring board that can look at the data after each each cohort enrolled.

Richard A. Miller: So we can look at the data, and we have a data monitoring board that can look at the data after each cohort is enrolled. And we're able to report that data or not. I mean, I don't anticipate we're going to be reporting it every week.

Speaker Change: And.

Speaker Change: We're able to report that theater or we're not I mean, I don't anticipate we're going to be reporting it every week.

Richard A. Miller: But at our discretion, we can be reporting that data. Now, there's also a very rich amount of biomarker data that's going to be accumulating during the study. We're measuring a number of different cytokines and lymphocyte subsets, et cetera, et cetera. And we know already from our lymphoma studies and other animal studies that we've done and published, we know what biomarkers, what cytokines are affected, like IL-4 and IL-5 and others. So what we would be looking for in each cohort, of course, is safety.

At our discretion, we can be reporting that data now theres also a very rich.

Speaker Change: Out of biomarker data that's going to be.

Speaker Change: Accumulating during this study we are measuring oh.

Speaker Change: A number of different cytokines in lymphocyte subsets et cetera, et cetera, and we know already from our lymphoma studies and our other animal studies that we've done and published we know what Biomarkers, what cytokines are affected like IL, four and IL, five and and and and and others. So.

What we would be looking for at each cohort of course is safety.

Richard A. Miller: We would be looking at changes in biomarkers in our treatment group relative to baseline. We would expect to see changes in IL-4 and 5 and all these things when comparing each patient to his or her baseline. And of course, we'll be, doctors will be assessing the efficacy based on the grading criteria as I mentioned earlier, the EASY score and the investigator global assessment. Now, in terms of dosing, as I mentioned, we know a lot about dosing already. So we're able to start at 100 milligrams BID.

Speaker Change: We would be looking at.

Speaker Change: Changes in Biomarkers in our treatment group relative to baseline.

Speaker Change: We would expect to see changes in IL, four and five and through all of these things as comparing each patient to his or her baseline.

Speaker Change: And of course will be doctors will be assessing the.

Speaker Change: Efficacy based on the grading criteria as I mentioned earlier, the easy score and the global investigator Global assessment. So we're going to learn a lot from each of these now.

Speaker Change: In terms of the dosing.

Speaker Change: We as I mentioned, we know a lot about the dosing already so we're able to start at 100 milligrams PID I would expect.

Richard A. Miller: I would expect to see something very early in this study, and I think we'll get an idea very early, not only about the efficacy but also about the biological activity. The reason that we're picking atopic dermatitis first is that it is very much what's called a TH2, T helper cell 2 disease, a disease mediated by IL-4 and 5 and 13.

Speaker Change: To see something very early in this study.

Speaker Change: And.

Speaker Change: I think we'll get an idea very early not only about the efficacy, but also about the biologic activity because remember.

Speaker Change: The reason that we're picking atopic dermatitis first is that it is very much a T. What's called a T. H two T helper cell to disease.

Speaker Change: Disease mediated by IL, four and five and 13 and and we we know that our drug blocks the th to function very well we learned this from our lymphoma studies and from our other other studies preclinical studies, so we're going to be able to determine very early in the study.

Richard A. Miller: And we know that our drug blocks the TH2 function very well. We learned this from our lymphoma studies and from our other studies, preclinical studies. So we're going to be able to determine very early in the study whether safety is an issue.

Speaker Change: <unk> about safety, we already know that from our lymphoma studies.

Richard A. Miller: We already know that from our lymphoma studies. We'll be able to determine whether or not we're having the immunologic effects that we expect. And of course, we'll be monitoring the clinical efficacy. Now, the immunologic effects are important because this becomes the entry point, the stepping stone to other immune diseases. What are the other immune diseases? Asthma is one that would be, you know, very much Th2, psoriasis, scleroderma, several other diseases, and we have a whole list of them on our website presentation.

Speaker Change: We will be able to determine whether or not we're having the immunologic effects that we expect and of course, we'll be monitoring the clinical efficacy.

Speaker Change: Now the immunologic effects are important because this becomes the entry point the stepping stone to other immune diseases. What are the other immune diseases asthma as one that would be you know it was very much th two.

Speaker Change: Psoriasis scleroderma is there's several other diseases, we have a whole list of them on or on our website presentation.

Richard A. Miller: So this is a very important study in that we get data quickly, and it's very informative not only for the purpose of atopic dermatitis, but it opens up the whole field. Basically, this study puts ITK inhibition on the map as an important therapeutic modality for a host of immune diseases. It's very reminiscent of an antibody that I worked on called Rituxan, where what we learned about lymphoma taught us about what happens to B-cells, etc., and that opened the door to a lot of other dermatologic and immunologic diseases.

Speaker Change: So so this is a very important study and that we get data quickly and it's very informative not only for the purpose of atopic dermatitis, but it opens up the whole field.

Speaker Change: <unk>.

Speaker Change: Acyclic. This study puts ITK inhibition on the map as a.

Speaker Change: Important therapeutic modality for a host of immune diseases, it's very reminiscent of an antibody that I worked on call Rituxan.

Speaker Change: And where we what we learned in lymphoma taught us about what happens to b cells et cetera, and that opened the door for a lot of other dermatological immunologic diseases.

Richard A. Miller: So that was a long way to answer your question, but I wanted to make sure that we really had the proper perspective. I appreciate the question. Did I forget anything?

Speaker Change: So that was a long way to answer your question, but I wanted to make sure that we really had a proper perspective I appreciate the question.

Speaker Change: Did I forget it thank you so much.

Operator: Great. Thank you, and there are no further questions at this time. I'll turn the floor to you.

Speaker Change: Thank you and there are no further questions at this time I'll turn the floor back to Richard Miller for closing remarks. Thank.

Richard A. Miller: [inaudible] Thank you, operator. Well, I want to thank everyone for participating in the call today. We look forward to giving additional updates each quarter and advancing Socolitinib and other products in the coming months. Thank you very much. Thank you. This concludes today's call.

Richard A. Miller: Thank you operator, well I want to thank everyone for participating in the call today.

Richard A. Miller: We look forward to giving additional updates each quarter end.

Speaker Change: Advancing socal isn't there then the other products.

Speaker Change: In our in the coming months, Thank you very much.

Speaker Change: Thank you. This concludes today's call all parties may disconnect have a good day.