Q4 2024 Corvus Pharmaceuticals Inc Earnings Call
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Unknown Attendee: Good afternoon, everyone. Thank you for standing by. And welcome to the Corvus Pharmaceuticals fourth quarter and full year 2024 business update and financial results conference call.
Good afternoon, everyone and thank you for standing by and welcome to the Cleveland Surgical's fourth quarter and full year 2020 for a business update and financial results Conference call.
Unknown Attendee: 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.
At this time all participants are in a listen only mode.
We will conduct a question and answer session.
Speaker Change: And instructions will follow at that time. It is now my pleasure to turn nickel ore registers that Google FBL chemistry. Thank you Pease go ahead Sir.
Zack Kubow: It is now my pleasure to turn the call over to Mr. Zack Kubow of Friel Chemistry. Thank you. Please go ahead, sir. Thank you, operator. And good afternoon, everyone.
Speaker Change: Thank you operator, and good afternoon, everyone. Thanks for joining us for the Corvus Pharmaceuticals fourth quarter and full year 2020 for a business update and financial results conference call on.
Zack Kubow: Thanks for joining us for the Corvus Pharmaceuticals fourth quarter and full year 2024 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, Leiv Lea, Chief Financial Officer, Jeff Arcara, Chief Business Officer, and Ben Jones, Senior Vice President of Regulatory and Pharmaceutical Science. The executive team will open the call with some prepared remarks, followed by a question and answer period.
Speaker Change: On the call to discuss the results and business updates are Richard Miller, Chief Executive Officer Life, Wheat, Chief Financial Officer, Jeff Archera, Chief Business Officer, and Ben Jones, Senior Vice President of regulatory and pharmaceutical Sciences.
Speaker Change: 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 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, including the risks and uncertainties described in Corvus's annual report on Form 10-K for the year ended December 31, 2024, that was filed today and other filings the company makes with the SEC from time to time. The company undertakes no obligation to publicly update or revise any forward-looking statements except as required by law.
Speaker Change: I would like to remind everyone that comments made by management today and answers to questions will include forward looking statements.
Speaker Change: We're 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, including the risks and uncertainties described in corpus of annual report on Form 10-K for the year ended December 31, 2024 that was filed today.
Speaker Change: <unk> and other filings the company makes with the SEC from time to time.
Speaker Change: The company undertakes no obligation to publicly update or revise any forward looking statements, except as required by law with that I'd like to turn the call over to lately.
Leiv Lea: With that, I'd like to turn the call over to Leif Lea. Thank you, Zack. I will begin with a quick overview of our fourth quarter and full year 2024 financials, and then turn the call over to Richard for a business update. Research and development expenses in the fourth quarter 2024 total $6 million compared to $4 million for the same period in 2023. The $2 million increase was primarily due to an increase in so-called clinical trial expense. R&D expenses for the full year 2024 totaled $19.4 million compared to $16.5 million for the full year 2023. For the full year 2024, the increase of approximately 2.9 million dollars was primarily due to higher clinical trial costs associated with the development of socolitin.
Speaker Change:
Lately: Thank you Zack.
Speaker Change: Excuse me I will begin with a quick overview of our fourth quarter and full year 2020 for financials, and then turn the call over to Richard for a business update.
Speaker Change: Research and development expenses in the fourth quarter 2024 totaled $6 million compared to $4 million for the same period in 2023.
Speaker Change: The 2 million dollar increase was primarily due to an increase in socal at the clinical trial expenses.
Speaker Change: R&D expenses for the full year 2024 totaled $19 $4 million compared to $16 5 million for the full year 2023.
Speaker Change: For the full year 2024, the increase of approximately $2 $9 million was primarily due to higher clinical trial costs associated with the development of circle at Nib.
Leiv Lea: The net loss for the fourth quarter 2024 was $12.1 million, including a non-cash loss of $2.2 million related to Angel Pharmaceuticals, our partner in China. In addition, we recorded a non-cash loss of $2.3 million from the change in fair value of Corvus's warrant liability during the fourth quarter of 2024. This compares to a net loss of $6.7 million for the same period in 2023, which included a $1.4 million non-cash loss related to Angel Pharmaceuticals. The net loss for the full year 2024 was $63.3 million, including a $3.2 million non-cash loss related to Angel and a non-cash loss of $33.4 million for the change in fair value of Corvus's warrant liability during the year.
Speaker Change: The net loss for the fourth quarter, 2024 was $12 $1 million, including a noncash loss of $2 $2 million related to Angel pharmaceuticals, our partner in China.
Speaker Change: In addition, we recorded a noncash loss of $2 $3 million from the change in fair value of choruses warrant liability during the fourth quarter of 2024.
Speaker Change: This compares to a net loss of six.
Speaker Change: $6 $7 million for the same period in 2023, which included a $1 4 million noncash loss related to Angel pharmaceuticals.
Speaker Change: The net loss for the full year, 2024 was $63 $3 million, including a $3 2 million noncash loss related to Angel and a noncash loss of $33 4 million for the change in fair value of choruses warrant liability during the year.
Leiv Lea: This compares to an... This compares to a net loss of $27.0 million, including a $5.3 million non-cash loss related to Angel for the full year 2023. Total stock compensation expense for the fourth quarter and full year 2024 was $0.8 million and $3 million, respectively, compared to $0.6 million and $2.1 million for the same periods in 2022. As of December 31, 2024, Corvus had cash, cash equivalents and marketable securities totaling $52 million as compared to $27.1 million at December 31, 2023.
Speaker Change: This compares to it.
Speaker Change: Excuse me. This compares to a net loss of $27.0 million, including a $5 3 million noncash loss related to angel for the full year 2023.
Speaker Change: Total stock compensation expense for the fourth quarter and full year 2024 was <unk> eight.
Speaker Change: $8 million and $3 million, respectively, compared to <unk> 6 million and $2 1 million for the same periods in 2023.
Speaker Change: As of December 31, 2024, Corvus had cash cash equivalence and marketable securities totaling $52 million as compared to $27 $1 million at December 31, 2023.
Leiv Lea: of note, associated with our financing in May 2024. We also sold common stock warrants that have an exercise price of $3.50 and expire on June 30 2025. Two investors early exercised their warrants during the fourth quarter 2024, resulting in $18.6 million in cash to the company. If all the remaining warrants are exercised, we will receive approximately $41 million in additional cash. Based on our current plans, we anticipate our cash provides runway into the first quarter of 2026.
Speaker Change: Note.
Speaker Change: Associated with our financing in May 2024, we also sold common stock warrants that have an exercise price of $3.50 and expire on June 30th 2025.
Speaker Change: To investors early exercise their warrants during the fourth quarter of 2024, resulting in an $18 $6 million in cash to the company.
Speaker Change: If all of the remaining warrants are exercised we will receive approximately $41 million in additional cash.
Speaker Change: Based on our current plans, we anticipate our cash provides runway into the first quarter of 2026.
Richard Miller: I will now turn the call over to Richard, who will discuss our clinical progress and elaborate on our strategy and Thanks, Leif, and good afternoon, everyone.
Speaker Change: I will now turn the call over to Richard who will discuss our clinical progress and elaborate on our strategy and plans.
Richard: Thanks, Lisa and good afternoon, everyone. Thank you for joining us today for our business update call.
Richard Miller: Thank you for joining us today for our business update call. As we look into 2025, we remain optimistic on the potential for Socolitinib to provide a powerful new approach for the treatment of a broad range of immune diseases and cancer. Socolitinib is well positioned as a first-in-class oral therapy that selectively inhibits ITK to modulate and control parallel signaling pathways in the immune system. Our confidence is backed by a strong and growing body of evidence. both from our clinical efforts and preclinical research conducted by us and others. First, we have reported a 39% objective response rate from our phase one trial of Socolitinib in patients with relapsed T-cell lymphoma.
Richard: As we look into 2025, we remain optimistic on the potential for Socal isn't it to provide a powerful new approach for the treatment of a broad range of immune diseases and cancer.
Richard: So call it and it is well positioned as a first in class oral therapy that selectively inhibits ITK to modulate and controlled parallel signaling pathways in the immune system.
Richard: Our confidence is backed by a strong and growing body of evidence both from our clinical efforts and preclinical research conducted by us and others.
Richard: First we have reported a 39% objective response rate from our phase one trial of so-called Nip in patients with relapsed T cell lymphoma.
Richard Miller: This included a 26% complete response rate, which is more than double the rate seen with standard chemotherapy. Based on this data, we are enrolling a registrational phase 3 trial of Socolitinib in patients with relapsed peripheral T-cell lymphoma, and we have gained a significant amount of experience that we are applying to our other Socolitinib programs. Second, we observed a favorable safety and efficacy profile from interim data from our phase one trial of Socolitinib in patients with moderate to severe atopic dermatitis. This includes significant responses in the Socolitinib treatment groups compared to placebo for the clinically significant endpoints of Investigator Global Assessment, or IGA-001, and eczema area and severity index, or EASY75.
Richard: This included a 26% complete response rate, which is more than double the rates seen with standard Chemotherapies based.
Based on this data we are enrolling a registrational phase III trial of so-called isn't it in <unk>.
Richard: Patients with relapsed peripheral T cell lymphoma, and we have gained a significant amount of experience that we are applying to our other so-called at knit programs.
Richard: Second.
Richard: We observed a favorable safety and efficacy profile from interim data from our phase one trial of Socal isn't it in patients with moderate to severe atopic dermatitis. This includes significant responses in the so-called lytton of treatment groups compared to placebo for the clinically significant endpoints.
Richard: Of investigator global assessment, or Iga zero, or one and exited area and severity index or easy 75.
Richard Miller: Third, preclinical data supports the potential of ITK inhibition in a broad range of indications, including solid tumors, immune conditions such as autoimmune lymphoproliferative syndrome, or ALPS, systemic sclerosis, pulmonary fibrosis, and graft-versus-host disease, and inflammatory conditions such as asthma, psoriasis, and inflammatory bowel disease. The data also highlights its mechanism of action, skewing differentiation to Th1 cells, reducing Th2 and Th17 cells and their downstream cytokines, and promoting a switch to T-regulatory cells that suppress inflammation. Given the broad applicability of its mechanism of action, we view the potential of ITK inhibition as analogous to BTK inhibition, a category that members of the Corvus team, including myself, helped to develop.
Richard: Third preclinical data supports the potential of ITK inhibition in a broad range of indications, including solid tumors immune conditions, such as autoimmune litho proliferative syndrome, or Alps, systemic sclerosis, pulmonary fibrosis, and graft versus host disease and inflammatory conditions such as <unk>.
Richard: Psoriasis is an inflammatory valve disease.
Richard: The data also highlight its mechanism of action skewing differentiation to th one cells, reducing th two in th 17 cells and their downstream cytokines and promoting a switch to two rate T regulatory cells that suppress inflammation.
Speaker Change: Given the broad applicability of its mechanism of action, we view the potential of ITK inhibition as analogous to be Teekay inhibition, a category that members of the corvus team, including myself helped to develop.
Richard Miller: BTK inhibitors were first approved for B-cell malignancies and then expanded into autoimmune conditions.
Speaker Change: PTK inhibitors were first approved for B cell malignancies, and then expanded into autoimmune conditions.
Richard Miller: Today, I will recap our previously reported data in atopic dermatitis and next steps for the trial, share some detail on the recently initiated NIH trial in ALPS, and highlight the upcoming milestones for Socolitin. In January, we reported interim data from the Phase I trial of Socolitinib in patients with moderate to severe atopic dermatitis. The trial includes four cohorts that are enrolling 16 subjects each at a 3-to-1 ratio of active to placebo, 12 active, 4 placebo. The trial is double-blind, meaning the patient and the doctor do not know what they're taking. The active medicine and placebo are indistinguishable tablets.
Speaker Change: Today, I will recap our previously reported data in atopic dermatitis and next steps for the trials share some detail on the recently initiated NIH trial in Alps, and highlight the upcoming milestones for so-called isn't it.
Speaker Change: In January we reported interim data from the phase one trial of so-called isn't it in patients with moderate to severe atopic dermatitis.
Speaker Change: <unk> trial includes four cohorts that are enrolling 16 subjects each at a three to one ratio of active to placebo 12 active for placebo.
Speaker Change: The trial is double blind, meaning the patient and the Doctor do not know what they're taking the active medicine and placebo are indistinguishable tablets.
Richard Miller: The company and the Data Review Committee are not blind. The treatment period is 28 days, and then we follow patients off therapy for another 30 days. The 28-day treatment period is relatively short compared to later stage atopic dermatitis studies with other agents, which typically treat up to 16 weeks or longer. The primary endpoint is safety and tolerability. Secondary endpoints measure based on IGA and EASY scores, along with patient reported measures of itch and biomarker. The first two cohorts received Socolitinib doses of 100 mg twice a day and 200 mg once per day. The same total dose of drug was used in the first two cohorts.
Speaker Change: The company and the data review committee are not blinded. The treatment period is 28 days and then we followed patients off therapy for another 30 days.
Speaker Change: The 28 day treatment period is relatively short compared to later stage atopic dermatitis studies with other agents, which typically treat up to 16 weeks or longer.
Speaker Change: The primary endpoint is safety and Tolerability Tolerability secondary endpoints measure based on Iga and easy scores along with patient reported measures of itch and Biomarkers.
Speaker Change: The first two cohorts received so-called isn't the doses of 100 milligrams twice a day and 200 milligrams once per day. The same total dose of drug was used in the first two cohorts.
Richard Miller: Based on our lymphoma studies, we know that 100 milligrams will provide 50% to 80% occupancy of the target, and 200 milligrams will provide about 80% to 100% occupancy. In January, we reported data from 16 patients in Cohort 1 and 10 patients in Cohort 2, for which 28 days of treatment had been completed. In total, from the combined cohort 1 and 2, this included 19 patients treated with sopalitinib and 7 patients treated with placebo. In the Socolitinib group, 26% achieved IgA0 or 1, and 37% achieved EZ75. Recall, these have been accepted as measures of clinical benefit and have been used as the basis for regulatory approval for several approved treatments for atopic dermatitis.
Speaker Change: Based on our lymphoma studies, we know that 100 milligrams will provide 50% to 80% occupancy of the target and 200 milligrams will provide about 80% to 100% occupancy.
Speaker Change: In January we reported data from 16 patients in cohort, one and 10 patients in cohort two for which 28 days of treatment had been completed.
Speaker Change: In total from the combined cohort one and two this included 19 patients treated with so-called isn't it and seven patients treated with placebo.
Speaker Change: In the so-called at Nib group, 26% achieved Iga zero or one and 37% achieved easy 75.
Speaker Change: Recall this has been accepted as measures of clinical benefit and had been used as the basis for regulatory approval for several approved treatments for atopic dermatitis.
Richard Miller: In the placebo group, no patients achieved IgA0 or 1 or EZ75. No significant safety issues were observed and no clinically significant laboratory abnormalities were seen. Cohort three of the trial, which administers a dose of 200 milligrams twice a day, that is twice the total daily dose we used in the earlier cohorts, is nearing completion of enrollment, and some patients have already reached the 28-day follow-up period. The efficacy results so far in the trial, including full Cohort 1 and 2, and the initial experience in Cohort 3, have been positive and consistent with what we have reported to date.
Speaker Change: In the placebo group no patients achieved Iga zero or one or easy 75.
Speaker Change: No significant safety issues were observed and no clinically significant leverage laboratory abnormalities were seen.
Cohort three of the trial, which administers a dose of 200 milligrams twice a day that is twice the total daily dose we used in the earlier cohorts is nearing completion of enrollment and some patients have already reached the 28 day follow up period.
Speaker Change: The efficacy results so far in the trial, including full cohort, one and two and the initial experience in cohort three have been positive and consistent with what we have reported to date.
Richard Miller: No patients in the active treatment groups received concomitant topical steroids or required rescue medications. One patient in the placebo group did receive concomitant topical corticosteroids. In cohorts one and two, two placebos experienced flares in their disease during the 28-day treatment period, whereas no disease flares were seen in the patients receiving active drug during the 28-day treatment period, as well as the follow-up period off treatment. Socolitinib has been very safe to date as well, with no patients requiring interruption of therapy.
Speaker Change: No patients in the active treatment groups received concomitant topical steroids or required rescue medications one patient in the placebo group did receive concomitant topical corticosteroids.
Speaker Change: In cohorts, one and two two placebos experienced players in their disease. During the 28 day treatment period, whereas no disease flares were seen in the patients receiving active drug during the 28 day treatment period as well as the follow up period off treatment.
Speaker Change: So call. It never has been very safe to date as well with no patients requiring interruption of therapy.
Richard Miller: We now have experience in over 100 patients with lymphoma and atopic dermatitis, representing more than 9,000 patient days of treatment, including patients with lymphoma on therapy for up to two years. We continue to believe that Socolitinib is an active medicine for atopic dermatitis with several advantages. Oral Root of Administration, Attractive Safety Profile, a novel mechanism of action with an opportunity for unique positioning, including the potential to bridge between topical therapies and systemic injectables.
Speaker Change: We now have experience in over 100 patients with lymphoma, and atopic dermatitis, representing more than 9000 patient days of treatment, including patients with lymphoma on therapy for up to two years.
Speaker Change: We continue to believe that so-called isn't it is an active medicine for atopic dermatitis.
Speaker Change: With several advantages.
Speaker Change: Oral route of administration attractive safety profile, a novel mechanism of action with an opportunity for unique positioning, including the potential to bridge between topical therapies and systemic injectables.
Richard Miller: We plan to report data covering the first three cohorts at the Society of Investigative Dermatology meeting taking place May 7 to 10 in San Diego. Our abstract has already been accepted for an oral and poster presentation at this meeting.
Speaker Change: We plan to report data covering the first three cohorts at the society of investigative Dermatology meeting taking place may seven to 10 in San Diego.
Speaker Change: Our abstract has already been accepted for an oral and poster presentation at this meeting.
Richard Miller: Outside of atopic dermatitis, we continue to enroll patients in our registrational phase three trial of socolitinib in patients with relapsed PTCL. Recently, we presented updated data from our Phase I trial at the T-cell lymphoma forum with longer follow-ups showing that the median progression-free survival is 6.2 months, and the 18-month progression-free survival is 30%. The median duration of response was 17.2 months. PFS, or progression-free survival, is the primary endpoint of our Phase 3 trial, which is comparing socolitinib to either bilinostat or pralatrexate, the standard-of-care agents with reported median PFSs of about 3 months and 18-month PFSs of under 20%.
Speaker Change: Outside of atopic dermatitis, we continue to enroll patients in our Registrational phase III trial of <unk> in patients with relapsed PTC L.
Speaker Change: Recently, we presented updated updated data from our phase one trial at the T cell lymphoma Forum.
Speaker Change: With longer follow up showing that the median progression free survival is six two months and the 18 months progression free survival is 30%.
Speaker Change: The median duration of response was $17 two months.
Speaker Change: PFS or progression free survival is the primary endpoint of our phase III trial, which is comparing <unk> to either Belinda stat or <unk>. The standard of care agents with reported median PFS PFS as of about three months and 18 months PFS as of <unk>.
Speaker Change: <unk>, 20%.
Richard Miller: We also have recently announced the initiation of enrollment in a phase two trial of Socolitinib in patients without autoimmune lymphoproliferative syndrome. This study not only addresses a disease with unmet need, but will also provide additional information on the activity of selective ITK inhibition in a serious autoimmune disease. ALPS patients are born with a genetic mutation in FAS signaling that results in lymphoproliferation and a myriad of autoimmune problems such as anemia, neutropenia, thrombocytopenia, and others. Some of these patients go on to also develop malignant lymphomas.
Speaker Change: We also have recently announced the initiation of enrollment in a phase two trial of so called <unk> in patients with ALS autoimmune Lymphoproliferative syndrome.
Speaker Change: This study not only addresses a disease with unmet need but will also provide additional information on the activity of selective ITK inhibition in a serious autoimmune disease.
Speaker Change: Alps patients are born with a genetic mutation in SaaS signaling that results in LIFO proliferation, and a myriad of autoimmune problems, such as anemia, neutropenia thrombocytopenia and others.
Speaker Change: Some of these patients go on to also develop malignant lymphomas.
Richard Miller: The ALPS trial is being conducted under a clinical research and development agreement with the National Institutes of Allergy and Infectious Diseases at NIH. It will enroll up to 30 patients aged 16 years or older with confirmed ALPS based on genetic testing. There will be two dosing cohorts, 200 milligrams or 400 milligrams of Socolitinib twice per day for a period of up to 360 days. The primary endpoint of the trial is efficacy, determined by reductions in spleen and lymph node volumes, as measured by CTC. In addition, improvements in cytopenias, or lowered blood cell levels, will be assessed by complete blood Improvements in cytopenias can improve quality of life and overall health and serve as a biomarker associated with Alps disease activity, including autoantibody levels that are reactive with red cells, white cells, and or platelets.
Speaker Change: The Alps trial is being conducted under a clinical research and development agreement with the National institutes of allergy and infectious diseases at NIH.
Speaker Change: It will enroll up to 30 patients aged 16 years or older with confirmed Alps based on genetic testing.
Speaker Change: There will be two dosing cohorts 200 milligrams or 400 milligrams, a so-called twice per day for a period of up to 360 days.
Speaker Change: The primary endpoint of the trial is efficacy determined by reductions in spleen and lymph node volumes as measured by C. T. Scans. In addition improvements in Cytopenia is or lowered blood cell levels will be assessed by complete blood counts improvements inside of peneus can improve quality of <unk>.
Speaker Change: And overall health and serve as a biomarker associated with Alps disease activity, including auto antibody levels that are reactive with red cells white cells <unk> platelets.
Richard Miller: Secondary endpoints include safety and tolerability.
Speaker Change: Secondary endpoints include safety and Tolerability.
Richard Miller: We are also planning a single-agent so-called neb-solid tumor trial in relapsed renal cell cancer, or RCC, representing a new approach to immunotherapy of this disease. We plan to initiate this trial during the third quarter of 2025.
We are also planning a single agents so call. It nips solid tumor trial in relapsed renal cell cancer or RCC, representing a new approach to immuno therapy of this disease. We plan to initiate this trial during the third quarter of 2025.
Richard Miller: Outside of Socolitinib, we also continue to advance our other clinical stage development programs. We have been one of the leaders in the development of Adenosine A2A Receptor Antagonists for the treatment of cancer with Cifer Adenate. This includes our Phase 1B2 clinical trial that is being conducted in collaboration with the Kidney Cancer Research Consortium. The trial was evaluating ciferadenant or ciferadenant as a potential first line therapy for metastatic renal cell cancer in combination with ipilimumab and nivolumab. The study has reached full enrollment of 60 patients at sites including MD Anderson, Vanderbilt, Duke, and the University of Pennsylvania.
Speaker Change: Outside of so-called we also continue to advance our other clinical stage development programs.
Speaker Change: We have been one of the leaders in the development of adenosine <unk> receptor antagonist for the treatment of cancer with Sypher a dent at this includes our phase <unk> clinical trial that is being conducted in collaboration with the kidney cancer Research consortium.
Speaker Change: <unk> was evaluating <unk> or so for Dennis as a potential first line therapy for metastatic renal cell cancer in combination with Illumina Mab and <unk>.
Speaker Change: This study has reached full enrollment of 60 patients at sites, including M. D Anderson, Vanderbilt, Duke and the University of Pennsylvania.
Richard Miller: The patients are being followed, and we anticipate our partners at the Kidney Cancer Research Consortium will present data from the trial sometime later in 2025.
Speaker Change: The patient the patients are being followed and we anticipate our partners at the kidney cancer Research consortium will present data from the trial sometime later in 2025.
Richard Miller: Finally, I should mention that we are advancing several second and third generation ITK selective inhibitors designed to preferentially affect particular ITK signaling pathways. Summarizing the outlook for the remainder of 2025, we remain focused on advancing the broad opportunity for socolitinib, which has several potential upcoming catalysts. This includes, number one, additional data from the phase one trial in atopic dermatitis in May at the Society for Investigative Dermatology meeting. Number two, full data from the phase one trial in atopic dermatitis in the third quarter. Number three, initiating a phase two clinical trial with socolitinib in solid tumors in the third quarter of 2025 with initial data anticipated in the first half of 2026.
Speaker Change: Finally, I should mention that we are advancing several second and third generation ITK selective inhibitors designed to preferentially affect particular ITK signaling pathways.
Speaker Change: Summarizing the outlook for the remainder of 2025, we remain focused on advancing the broad opportunity for so-called at Nib, which has several potential upcoming catalyst. This includes number one additional data from the phase one trial in atopic dermatitis in may at the society.
Speaker Change: For investigative dermatology meeting.
Speaker Change: Number two full data from the phase one trial in atopic dermatitis in the third quarter.
Speaker Change: Number three initiating a phase II clinical trial with so-called isn't it in solid tumors in the third quarter of 2025 with initial data anticipated in the first half of 2026.
Richard Miller: Number four, initiating a Phase II atopic dermatitis trial in late 2025. Number five, continuing to activate sites and drive enrollment in the registrational Phase III trial of Socolitinib and PTCL, driving towards interim data in late 2026. And depending on enrollment trends, it's possible we could see initial data from the Phase 2 ALP study in late 2025 or early 2026. Our current cash gives us runway into the first quarter of 2026, allowing us to execute on these important milestones and further demonstrate the value of our programs, and in particular, the significant opportunity for ITK inhibition in immunology and cancer.
Speaker Change: Number four initiating a phase two atopic dermatitis trial in late 2025.
Speaker Change: Number five continuing to activate sites and drive enrollment in the Registrational phase III trial.
Speaker Change: So-called at Nib, and PTC L driving towards interim data in late 2026.
Speaker Change: And depending on enrollment trends, it's possible we could see initial data from the phase two ALS study in late 2025 or early 2026.
Speaker Change: Our current cash gives us runway into the first quarter of 2026, allowing us to execute on these important milestones and further demonstrate the value of our programs and in particular, the significant opportunity for ITK inhibition in immunology and cancer.
Richard Miller: We look forward to providing updates on our programs in the coming quarters.
Speaker Change: We look forward to providing updates on our programs in the coming quarters.
Unknown Attendee: I will now turn the call over to the operator for a questions and answer period, operator. Thank you.
Speaker Change: I will now turn the call over to the operator for our questions and answer period operator.
Thank you ladies and gentlemen, we will now begin the question and answer session should you have a question. Please press star followed by the one on your telephone keypad should you wish to cancel your request. Please press star followed by the team if you're using a speaker phone lift your handset before pressing any keys one moment. Please for your first question.
Unknown Attendee: Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press star followed by the one on your telephone keypad. Should you wish to cancel your request, please press star followed by the two. If you are using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. Thank you.
Speaker Change: Thank you and your first question comes from the line of Jeff Jones from Oppenheimer. Please go ahead.
Jeff Jones: And your first question comes from the line of Jeff Jones from Oppenheimer. Please go ahead. Good afternoon, guys, and thanks for taking the question. Lots of data updates to come, so really exciting time for you guys.
Jeff Jones: Good afternoon, guys and thanks for taking the question.
Jeff Jones: Lots of data updates to come so really exciting time for you guys I guess.
Richard Miller: I guess, starting out on the AD front and the update in May, will the, should we expect full data on Cohort 3 as well as additional patients on Cohort 2? And then, as you think about the efficacy hurdle there, what do you guys have in your head to move this ahead into the Phase 2a that you just mentioned, or, you know, and just competitiveness in the field? Okay, so Jeff, the meeting in May, the Society of Investigative Dermatology, we intend to report the full data set on Cohort 1, the full data set on Cohort 2.
Starting out on the a D Ron and the update.
Jeff Jones: In May we.
Jeff Jones: Will the mobile where should we expect full data on cohort three as well as additional patient from cohort two.
Jeff Jones: And then as you think about the efficacy hurdle there.
Jeff Jones: What do you guys have in your head to move this ahead in the phase two eight that you just mentioned.
Jeff Jones: Sure.
Jeff Jones: Yeah, and just competitiveness in the field.
Jeff Jones: Okay.
Jeff Jones: So Jeff the meeting in May the society of investigative dermatology, we intend to report the full data set on cohort one the full data set on cohort two we have already completed enrollment and follow up in those two cohorts cohort three is almost completed enrollment 28 day follow up was coming in on patients now.
Richard Miller: We've already completed enrollment and follow-up in those two cohorts. Cohort 3 is almost completed enrollment, 28-day follow-up is coming in on patients now. We're also going to have additional one-month follow-up beyond that. So we'll have the full data for Cohort 1, 2, and 3. I also expect to have biomarker data for those first three cohorts as well. Okay, great.
Jeff Jones: We're also going to have additional one month follow up beyond that so we will have the full data for cohort one two and three I also expect to have biomarker data for those first three cohorts as well.
Jeff Jones: Okay great.
Richard Miller: And then. just in terms of the success hurdles and efficacy bar that you guys are looking at. Well, first of all, we're pretty pleased with the efficacy we saw in cohort one and two. Let me remind you, you know, that's twenty eight days of treatment. We see what a thirty percent difference in some of these twenty five, thirty five percent difference between placebo, which was zero in cohort one and two and our actives. That's a pretty good number. And, you know, that number sustained or improved would be, you know, would be very good in our opinion.
Jeff Jones: And then.
Jeff Jones: Yeah.
Speaker Change: Just in terms of success hurdles and efficacy bar that you guys are looking at.
Speaker Change: Well first of all we're pretty pleased with the efficacy we saw in cohort one and two let me remind you of.
Speaker Change: That's 28 days of treatment.
Speaker Change: We see what a 30% difference in some of these $25, 35% difference between placebo, which was zero in cohort one and two in our actives, that's a pretty good number.
Speaker Change: And.
Speaker Change:
Speaker Change: That number sustained or improved would be would be very good.
Richard Miller: Now, of course, many people are asking about what would happen if we increase the duration of therapy. And that's something that we're we're thinking about and will come in time. So we're pretty pleased with the efficacy results we have to date in terms of a competitive landscape. Of course, we're oral. We have a different mechanism of action. Safety looks really good so far.
Speaker Change: In our opinion now of course.
Speaker Change: People are asking about what would happen if we increase the duration of therapy and that's something that we're thinking about and will come in time. So we're pretty pleased with the efficacy results we have to date.
Speaker Change: In terms of a competitive.
Speaker Change: Landscape of course, where oral we have different mechanism of action.
Speaker Change: Safety looks really good so far convenience.
Richard Miller: Convenience. The. Study, the design of our study was really intended to determine whether or not selective inhibition of ITK had some role in immune disease. Is there some signal, some indication of efficacy in an autoimmune disease? And I think we've got that. Now, of course, as we think about phase two trials and beyond, we'll begin to think about, you know, what's required for registration, et cetera. But I think from a competitive standpoint, to my knowledge, we're the only selective ITK inhibitor. I know there are some other companies that have ITK inhibitors and are talking about it now, but they're not selective, and we view that as critical in the biology.
Speaker Change: The.
Speaker Change: Ah study.
Speaker Change: Design of our study was really.
Speaker Change: Intended to determine whether or not selective inhibition of ITK had some role in immune diseases. There are some signals some indication of efficacy in an autoimmune disease and I think we've got that.
Speaker Change: Now of course, as we think about phase II trials and beyond we'll begin to think about what was required for registration et cetera, but I think from a competitive standpoint to my knowledge, we're the only selective ITK inhibitor.
Speaker Change: I know there is some other companies that have ITK inhibitors and are talking about it now but they are they are not selective and we view that as critical in the biology.
Richard Miller: And so I think we're, you know, in pretty good shape on that.
Speaker Change: And so I think we're.
Speaker Change: In pretty good shape on this.
Jeff Jones: Great. Thanks, Richard. I'll hop back in queue. Thank you.
Speaker Change: Great. Thanks, Richard I'll hop back in queue.
Speaker Change: Thank you and your next question comes from the line of 18 Hussein off from Ladenburg timeline. Please go ahead.
Aydin Huseynov: And your next question comes from the line of Aydin Huseynov from Lindenburg, Thailand. Please go ahead. Hi, good afternoon, everyone. Richard, congratulations with the progress this quarter. I've got a couple of questions here. So regarding the potential Cohort 4, so could you clarify your plans for Cohort 4, whether you still would like to enroll in 400 milligrams? And just if you could give us like a general idea, what is the difference in terms of the doses? I mean, why would you like 400 milligram doses as compared to the oncology trial where your optimal dose is just 200 milligram?
Speaker Change: Hi, good afternoon, everyone.
Richard: Richard Congratulations with the progress this quarter I got a couple of questions here.
Speaker Change: So regarding the <unk>.
Speaker Change: Potential cohort four so could you clarify your plans for cohort four whether you still would like to enroll in 4400 milligrams and just if you could give us a general idea of what is the difference.
Speaker Change: In terms of the doses I mean, why would you why would do like 404 hundred milligram dose.
Speaker Change: <unk> to the oncology.
Speaker Change: Trial, what are you maximum what's your optimal doses just 200 milligram.
Richard Miller: Thank you, Aydin. Good question.
Speaker Change: Thank you Ed and good question.
Richard Miller: So, just for the benefit of everyone else, Cohort 1 was 100 milligrams BID, Cohort 2 was same total dose, 200 milligrams once a day, Cohort 3, 200 milligrams twice a day, and Cohort 4, as you indicate, would be 400 milligrams at the same total dose one time. So, before deciding whether we're going to do Cohort 4, that is the plan, but we want to look at the full data set from Cohort 3. We already have Cohort 1 and 2. We'll look at the data from Cohort 3, and then we'll decide whether we would do that or not.
Speaker Change: So just just for the benefit of everyone else cohort one was 100 milligrams of <unk> co.
Speaker Change: Cohort two was same total dose 200 milligrams once a day cohort three 200 milligrams twice a day and cohort four as you indicate would be 200 400 milligrams at the same total dose one time.
Speaker Change: So.
Before deciding whether we're going to do cohort for that is the plan, but we want to look at the full dataset from cohort three.
We already have cohort one and two we will look at the data from cohort three and then and then we'll decide.
Speaker Change: Whether we would do that or not.
Richard Miller: Right now, the plan is to do that, although we are thinking about other possibilities, like extending duration of therapy. You know, each of the doses, 100, 200, 400, is very good occupancy of the receptor. And, of course, as I've indicated in previous calls, we don't really know what it takes to get a clinical effect or a biologic effect in atopic dermatitis, whether you really need 100 percent occupancy. But even at our starting dose of 100, there's pretty good occupancy. So right now the plan is to do cohort four, but before we decide, you know, definitively on that, we want to look at our data.
Speaker Change: Right now the plan is to do that although we are thinking about other other possibilities like extending duration of therapy.
Speaker Change: You know each each of the doses 100, 200, 400 give very good occupancy of the receptor.
Speaker Change: And.
Speaker Change: Of course as I've indicated in previous calls.
Speaker Change: We don't really know what what it takes to get a clinical a factor biologic effect in atopic dermatitis.
Speaker Change: Whether you really need a 100% occupancy.
Speaker Change: But even at our starting dose of hundred Theres pretty good occupancy.
Speaker Change: So.
Speaker Change: Right now the plan is to do cohort four but before we decide.
It is lee on that well.
Speaker Change: Wanted to look at our data.
Richard Miller: It makes sense. And regarding the prior therapies, I know that many of those patients previously failed the PIXEN first two cohorts. How about the Cohort 3? Did you see the patients? Sorry, sorry, the PIXEN Naive, sorry, the first two cohorts. So, is the Cohort 3 also sort of mostly the PIXEN Naive patients? We have deliberately searched for sicker patients in Cohort 3. So we do have more dupixent and systemic treatment failures in cohort three. We also have, so far, I mean, we're not done with the cohort. We do appear to have higher baseline EASY scores.
Speaker Change: Okay. It makes sense.
Speaker Change: Regarding the prior therapies.
Speaker Change: I know that many of those patients previously failed to pick.
Speaker Change: First to cohort two cohort how about the cohort three did you see the patients.
Speaker Change: Sorry, sorry.
Speaker Change: And now you've sort of deferred cost.
Speaker Change: Is the cohort three also sort of mostly depiction of naive patients.
Speaker Change: We have deliberately.
Speaker Change: Searched for sicker patients in cohort three.
Speaker Change: So we do have more to pick scent and systemic treatment failures in cohort three we also have.
Speaker Change: So far I mean, we're not done with the cohort.
Speaker Change: We do appear to have higher baseline EZ scores. So we'll have to look at that and we'll see how that turns out whether there is whether there.
Richard Miller: So we'll have to look at that and we'll see how, you know, how that turns out. Whether there's, you know, whether there's a particularly good or effect in the DUPI failures, we don't know yet. We don't really know how that variable fits in yet. Okay, understood.
As a particularly good or effect in the two P failures, we don't know yet.
Speaker Change: We don't really know how that variable fits in yet.
Speaker Change: Okay understood and the last one is the biomarker question I think you had mentioned.
Richard Miller: And the last one is the biomarker question. I think you mentioned that you will be talking about biomarkers in May. So could you elaborate a little bit on that? What kind of biomarkers are out there for atopic dermatitis? Well, I would say that Some of the, some of the work that we presented back in January on biomarkers or in December is being confirmed in our ongoing studies. In addition, we've picked up a couple of other things that I think are quite interesting. You know, I've been talking about, we've been talking and studying these T-regulatory suppressor cells and other cells, and I think those are turning out to be extremely interesting.
Speaker Change: He will be talking about biomarkers.
Speaker Change: In may so could you elaborate a little bit on that what kind of biomarkers are out there for atopic dermatitis.
Speaker Change: Well, yes.
I would say that some of the some of the work that we presented back in January on Biomarkers or in December.
Is being confirmed in our ongoing studies. In addition, we've picked up a couple of other things that I think are quite interesting.
Been talking about we've been talking and studying.
Speaker Change: These T regulatory suppressor cells and other cells and I think those are turning out to be.
Speaker Change: Extremely interesting.
Aydin Huseynov: We continue to see a very durable effect of our treatment in patients who receive the drug. And I mean, it's a small data set, it's very early, but it's also very provocative. Okay, understood. Thanks so much. Thank you.
Speaker Change: We continue to see a very durable effect of our treatment in patients who received the drug.
Speaker Change: And I.
Speaker Change: I mean, its a small dataset, it's very early.
Speaker Change: But it's also very provocative at this point.
Speaker Change: Okay understood. Thanks, so much.
Speaker Change: Thank you and your next question comes from the line of <unk> of any <unk> from Mizuho Securities. Please go ahead.
Graig Suvannavejh: And your next question comes from the line of Graig Suvannavejh from Mizzou Health Securities. Please go ahead. Hi, this is Samman for Graig. Thanks for taking our questions. Maybe one on ALPS, just give that it's a new indication. Can you just tell us in terms of like the addressable patient population that you guys are kind of due diligence and also, you know, what if there's a subset of patients that would be ideal candidates for Socolipnib among people with ALPS? Thank you.
Speaker Change: Hi, This is Sam on for Greg. Thanks for taking our questions maybe one on a L. P. S. Just given that it's a new indication.
Can you just tell us in terms of like the addressable patient population that you guys are.
Speaker Change: Kind of due diligence and also.
Speaker Change: What if there is a subset of patients that would be ideal candidates for socal at Nab among people with Lps. Thank you.
Richard Miller: Okay, so in the United- so ALPS, or A-L-T-S, autoimmune lymphoproliferative syndrome, is a genetic disease. You're born with it. I'll give you a little background on the disease. Babies are born with it. They- at around age two, they start to develop anemia and big spleens and lymphadenopathy infections, and they get a diagnosis made, of course. And then they're on lifelong immunosuppressive therapies, cyclophosphamide, steroids, mTOR inhibitors, things like that. And they can be on that a long time. The disease is not curable. And they'll have waxing and waning adenopathy and cytopenias, anemia, neutropenia, thrombocytopenia. They can live 30, 40, 50 years old now.
Speaker Change: Okay. So in the United So Alps, our Lps autoimmune Lymphoproliferative syndrome is a genetic disease, you're born with it.
Speaker Change: I'll give you a little background on the disease base.
Speaker Change: Babies are born with it.
Speaker Change: At around age two they start to develop anemia and explains unless adenopathy.
Speaker Change: Sections and they get a diagnosis made of course and then they're on lifelong.
Speaker Change: Immunosuppressive therapies.
Speaker Change: Cyclophosphamide.
Speaker Change: <unk>.
Speaker Change: M Tor inhibitors things like that and they can be on that a long time, the disease, not curable and they'll have waxing and waning adenopathy inside opinions anemia neutropenia thrombocytopenia.
Speaker Change: They can live 30, 40 50 years old now.
Richard Miller: But they're, you know, they suffer a lot of the complications. They have massive splenomegaly. That's another problem they have, which sometimes can rupture. A subset of these patients, maybe 10, 20 percent, go on to develop malignant lymphomas. Usually, they're B-cell lymphomas. But the abnormal cell in ALPS is a T-cell. It's an abnormal T-cell called the double negative T-cell that does not have CD8 or CD4. I won't go into the biology of it. But it has a lot of ITK expression. and in our work looking at the effect of socolitinib in various murine autoimmune models, we found that the same, there's a strain of mouse called the MRL-LPR negative-negative mouse that has the very same mutation that you see in these patients, same disease basically, genetically.
Speaker Change: But there.
Speaker Change: They suffer a lot of the complications they have massive splenomegaly as another problem that has which sometimes can rupture.
Speaker Change: A subset of these patients maybe 10% 20% go on to develop malignant lymphoma, it's usually they're b cell lymphomas, but the abnormal cell and in Alps, as a T cell. It's an abnormal T cell called the double negative T cell that does or does not have CD eight or CD four I won't go into the biology of it but it has.
Speaker Change: What ITK expression.
Speaker Change: And.
Speaker Change: In our work looking at the effect of so-called isn't it in various.
Speaker Change: Mirroring autoimmune models, we found that the same there is a strain of mouse called the MRM LPR negative negative mouse that has the very same mutation that you see in these patient same disease basically genetically and when we when we treated animals with with our drug.
Richard Miller: And when we treated animals with our drug, it was dramatically effective, really dramatically effective. Cytopenias go reverse and become normal, splenomegaly, lymphadenopathy, all that thing, basically these animals become normal. And so that prompted us to say, hey, let's go treat the human genetic, you know, identical genetic disease in humans. And that led us to the NIAID that has a very big collection of these patients. Now, most pediatric hospitals have patients like this. And you asked about the market. There are about 2,500 patients with this disease in the United States currently. They live a long time.
Speaker Change: It was dramatically affected really dramatically effective.
Speaker Change: Cytopenia as go reverse and become normal splenomegaly lymphadenopathy OLED basically these animals become normal.
Speaker Change: So that prompted us to say.
Speaker Change: Hey, let's go treat the human genetics.
Speaker Change: Identical genetic disease in humans and that led us to the Nia idea that has a very big collection of these patients now most pediatric hospitals have patients like this.
Speaker Change: And you asked about the market.
Speaker Change: There are about 2500 patients with this disease in the United States currently.
Speaker Change: They live a long time, they lift to be aged 40, 50, as I said, some die sooner, but that in general as their lifespan.
Richard Miller: They live to be age 40, 50, as I said. Some die sooner, but that, in general, is their lifespan.
Richard Miller: I don't think there's any particular subset that would be, not to our knowledge now, that would be more or less amenable to this therapy, so I just, you know, we just don't know. Sometimes there are slightly different mutations in patients, but the main problem in the mouse and in the human beings is that their cells, their lymphocytes do not undergo apoptosis. Now, there's a very strong connection between T cell receptor signaling and apoptosis. Think about it when there's antigen or you have an infection. You want your T cells to proliferate, kill off the infection, but then you want those T cells to go away when the infection is eliminated.
Speaker Change: I don't.
Speaker Change: I think there is any particular subset that would be not to our knowledge now that would be more or less.
Speaker Change: Amenable to this therapy.
Speaker Change: So I just we just don't know.
Speaker Change: Sometimes there are slightly different mutations in patients, but the main problem in the mouse and in the human beings is that theyre ourselves there with the sites do not undergo a pop doses.
Speaker Change: Now there is a very strong connection between.
Speaker Change: T cell receptor signaling an apoptotic is think about it when there's antigen or do you have an infection you werent your T cells to proliferate kill off the infection, but then you want those T cells to go away.
Speaker Change: When the infection has eliminated that requires a pop doses that is <unk>.
Richard Miller: That requires apoptosis. That is regulated by ITK. ITK has many roles in various signaling pathways, and when you block ITK, you restore apoptosis to these cells. And so that's the rationale for this. So basically, Basically, this is a treatment that I think you would take for a long time. And, you know, given the safety we've seen so far, we think this could be very important.
Speaker Change: Regulated by ITK.
Speaker Change: ITK has many rules and various signaling pathways.
Speaker Change: And when you block ITK you restore a pop doses to these cells.
Speaker Change: And so that's the rationale.
Speaker Change: For this so basically.
Speaker Change: Basically this is a.
Speaker Change: A treatment that I think you would take for a long time.
Speaker Change: And.
Speaker Change: Given the safety we've seen so far we think this could be very important now also from a regulatory standpoint. This is not a disease I don't think where youre going to be asked to do big randomized clinical trials. So that's something else to.
Graig Suvannavejh: Now, also, from a regulatory standpoint, this is not a disease, I don't think, where you're going to be asked to do big randomized clinical trials. So that's something else to think about. We're very excited and interested in this disease, you can tell by my long-winded answer. And then finally, what this does is, I mean, this is really an opportunity to look at the effect of our drug on all sorts of autoimmune manifestations, anti-red cell antibodies, antiplatelet antibodies, all that sort of stuff, which we think will have important relevance to other autoimmune diseases. Does that answer your question?
Speaker Change: Think about.
Speaker Change: Okay.
Speaker Change: We're very excited and interested in this disease you can tell by my long winded answer and then finally, what this does is I mean this is really an opportunity to look at the effects of our drug on all sorts of autoimmune manifestations anti red cell antibodies anti platelet antibodies all of that sort of stuff, which we think.
Speaker Change: We will have important relevance to other autoimmune diseases.
Speaker Change: That answer your question probably.
Graig Suvannavejh: Probably. Definitely, very insightful. Thanks so much, Richard, for taking our questions. Thank you.
Speaker Change: Definitely very insightful. Thanks, so much Richard for taking a question.
Speaker Change: Thank you and your next question comes from the line of Roger song from Jefferies. Please go ahead.
Roger Song: And your next question comes in the line of Roger Song from Jeffreys. Please go ahead. Hi, this is Chacha Yang on for Roger.
Speaker Change: Hi, this is charging hang on for Roger I'm looking towards your phase two for.
Chacha Yang: I'm looking towards your phase two for AD, and I'm wondering if you can give some color on what subpopulations within the disease you're hoping to target. More specifically, if you could talk about aspects like prior medication use, baseline EASI scores, and then any geography and demographics insights, that would be great. Well, that's a pretty tough question, considering we haven't finished phase one yet, but moderate to severe atopic dermatitis, failed topical corticosteroids, or a systemic therapy, very similar to the criteria we're using now. I don't know if I would require, I mean, baseline easy scores to be moderate are 16 or greater.
Speaker Change: A D and I'm wondering if you can give some color on what sub populations within the disease are hoping to target.
Speaker Change: More specifically if you could talk about sex like prior medication use baseline <unk> scores and then any geography demographics insights that'd be great.
Speaker Change: Well, that's a pretty tough question, considering we haven't finished phase one yet but moderate to severe atopic dermatitis failed.
Speaker Change: Topical corticosteroids or a systemic therapy very similar to the criteria we're using now.
Speaker Change: I don't know if I would require I mean baseline easy scores to be moderate or 16 or greater so I don't think we would have any requirements beyond that.
Richard Miller: So I don't think we would have any requirements beyond that. You know, I think a typical study would be look at two different dose levels, plus a placebo. So probably a three arm study, maybe around 200 patients total. But, you know, that's an S, you know, kind of a approximate answer at this point, but that's all pretty standard. And the end point would be either EASY75, those who achieve EASY75, or IGA01. That's pretty standard endpoint.
Speaker Change: I think a typical study would be look at two different dose levels plus a placebo. So probably a three arm study may be around 200 patients total, but that's it.
Speaker Change: We had kind of a.
Speaker Change: Approximate answer at this point.
Speaker Change: But that's all pretty standard.
Speaker Change: Sounds good.
Speaker Change: But in the end point would be either EZ 75, those who achieve EZ 75, or Iga zero one.
Speaker Change: That's pretty standard point now.
Richard Miller: Great, thank you for that. Thank you.
Speaker Change: Great. Thank you for that.
Speaker Change: Thank you and your next question comes from the line of <unk> <unk> from Cantor. Please go ahead.
Daniel Browner: And your next question comes from the line of Li Watsek from Kantor. Please go ahead. Hi team, this is Daniel Browner on for Li.
Speaker Change: Hi team of sustaining Bronder on for Lee.
Richard Miller: I have a question about the prioritizing of opportunities for SOQL in oncology versus inflammatory disease and how you look at it as you move into later stage trials. Okay, well, right now we have Socolitinib in a phase three registration trial that could produce data in less than two years. And so we're pushing on all fronts as aggressively as we can. So, the idea, the strategy is try to get an approval in lymphoma, try to get an approval or in an immune disease. Now, we are aware of some of the issues with having a similar same drug for autoimmune disease and cancer.
Speaker Change: I have a question about the prioritizing of opportunities for <unk>, and oncology and inflammatory disease and how you look at it as you move into later stage trials.
Speaker Change: Okay.
Speaker Change: Well right now we have so called <unk> in a phase III registration trial that could produce data enlist in two years and so we're pushing on all fronts as aggressively as we can.
Speaker Change: <unk>.
Speaker Change: So.
Speaker Change: The idea of this strategy is trying to get an approval in lymphoma.
Speaker Change: Try to get an approval.
Speaker Change: In an immune disease now we are aware of some of the issues with having a similar same drug for autoimmune and Kent or human disease and cancer. We are very aggressive program in second and third generation compounds. We also think that the dosing and duration of therapy are going to be very different in.
Richard Miller: We have a very aggressive program in second and third generation compounds. We also think that the dosing and duration of therapy are going to be very different in oncology versus immunology. A very good example would be Rituxan, for example, which came out of my lab at IDAC. Rituxan is approved for lymphomas, as you know. It's also approved for rheumatoid arthritis, panthagus, ITP, and probably a few more autoimmune diseases. And there's really no issue with pricing because the treatment regimens are such that on a per milligram basis, it turns out to be pretty similar. So, our strategy now is push forward on all these fronts and, you know, get deeper and deeper into the pipeline.
Speaker Change: In oncology versus immunology very good example would be Rituxan for example, which which came out of my lab at Eyetech Rituxan is approved for lymphomas. As you know it is also approved for rheumatoid arthritis, pemphigus, ITT and probably a few more autoimmune diseases.
Speaker Change: And.
Really no issue with pricing because the treatment regimens are such that on a per milligram basis. It turns out to be pretty pretty similar so our strategy now is pushed forward on all these fronts and.
Speaker Change: Get deeper and deeper into.
Speaker Change: The.
Richard Miller: And, you know, at some point, of course, we recognize that autoimmune diseases is a vast undertaking. There's many different diseases and competitive areas. And, of course, we would, at the right time, consider some sort of a collaboration or partnership.
Speaker Change: And at.
Speaker Change: At some point of course, we recognize that auto immune diseases as asked undertaking there is many different diseases.
Speaker Change: Competitive areas and of course, we would at the right time consider.
Speaker Change: Some sort of a collaboration or partnership.
Daniel Browner: Okay, cool. Thank you so much for that detailed answer.
Speaker Change: Okay cool. Thank you so much for that detailed answer and the other question. We were wondering about as you alluded to earlier a little bit.
Daniel Browner: And the other question we were wondering about is, you alluded to earlier a little bit, the delay in the presentation of Cohort 4, is that more driven by your waiting and seeing of Cohort 3 results, or has there been a delay in enrollment more generally? No delay in enrollment. We're waiting to see the data from Cohort 3 and we'll make a decision about proceeding with Cohort 4 or maybe expand one of the other Cohorts. Okay, cool. Thank you so much.
Speaker Change: Hum.
Speaker Change: The delay in the presentation of cohort four is that more driven by your waiting and seeing of cohort three resolved or has there been a delay enrollment more generally.
Speaker Change: No delay in enrollment.
Speaker Change: Waiting to see the data from cohort three.
Speaker Change: And we'll make a decision about proceeding with cohort four or maybe maybe.
Speaker Change: Expand one of the other cohorts.
Speaker Change: Okay cool. Thank you so much.
Speaker Change: Okay.
Shen Li: Thank you. And your next question comes from the line of Shen Li from HC Wainwright. Please go ahead. Hi, good afternoon, and thanks for taking my question. I just have one on the upcoming solid tumor study that's been planned. I was wondering whether there are specific indications that you feel are most suitable for circoliminib, or will it be just a general basket study? And also, would you need to do a dose escalation again, or would you start with the PTCL dose? Thank you.
Speaker Change: Thank you and your next question comes from the line of Shan Li from H C. Wainwright. Please go ahead.
Shan Li: Hi, good afternoon, and thanks for taking my question.
Speaker Change: I just have one on the upcoming solid tumor study that's been planned I was wondering whether there are some.
Shan Li: As Tiffany indication set do you feel are.
Speaker Change: Most suitable for.
Speaker Change: So politically or will it be just a general basket study and also would you need to do a dose escalation again or would you start with the PTC.
Speaker Change: PTC altos thanks.
Richard Miller: So, the first part of the question, which tumors, I would start with the, we will start with the immune responsive tumors. So, what are those? Those are renal cell cancer, lung cancer would be good. Those would be probably the top choices to start because you want tumors where you think there's some evidence for immunotherapeutic effects. Melanoma might be another one, although that's a much less common disease and is, you know, adequately, somewhat adequately treated by other treatments. So, I would say, you know, renal, lung, I don't think we need to do a dose escalation, but certainly you would want to do different doses.
Speaker Change: So the first part of the question, which tumors.
Speaker Change: I would start with the we will start with the immune responses tumors. So what are those as a renal cell cancer lung cancer would be good those are the probably the top choices to start because you werent tumors, where you think there is some evidence for.
Speaker Change: Immuno therapeutic effects.
Speaker Change: Melanoma might be another one although that's much less common diseases.
Speaker Change: Adequately somewhat adequately treated.
Speaker Change: By other treatments, so I would say renal lung.
Speaker Change: I don't think we need to do.
Speaker Change: Dose escalation, but certainly you would want to do different doses you would want to look at different doses.
Richard Miller: You'd want to look at different doses. It wouldn't be a dose escalation in the usual sense that you're thinking of like a phase one oncology. But but you would probably want to look at different doses. But we have a pretty good handle now on, you know, the dose. And we have a very good pharmacodynamic marker, which is we know what it takes to saturate the ITK target. So, you know, 100 or 200, 300 or 400, we're all in the same ballpark. They're all going to give you pretty much the same, similar findings. Great. Thanks for that.
Speaker Change: Wouldn't be a dose escalation in the usual sense that youre thinking of like a phase one oncology study, but but.
Speaker Change: You would probably want to look at different.
Speaker Change: Doses, but we have a pretty good handle now on.
Speaker Change: The dose and we have a very good pharmacodynamic marker, which is we know what it takes to saturate ITK target.
Speaker Change: So you know one or 200 300 or 400 were all in the same ballpark theyre all going to be give you pretty much the same similar findings.
Speaker Change: Oh, great Thanks for that.
Richard Miller: Thank you.
Speaker Change: Thank you.
Unknown Attendee: There are no further questions at this time.
Richard: No further questions at this time I would now hand, the call back to Mr. Richard <unk> for any closing remarks.
Richard Miller: I will now hand the call back to Mr. Richard Miller for any closing remarks. Okay, I want to thank everyone for participating in the call, and we look forward to additional updates in the future. Thank you very much. Thank you.
Speaker Change: Okay I want to thank everyone for participating.
Speaker Change: In the call and we look forward to additional updates in the future. Thank you very much.
Speaker Change: Thank you and this concludes today's call. Thank you for participating you may all disconnect.
Unknown Attendee: And this concludes today's call. Thank you for participating. You may all disconnect.