Q1 2025 Corvus Pharmaceuticals Inc Earnings Call & Soquelitinib Phase 1 Clinical Trial Update
Good afternoon, everyone. Thank you for standing by and welcome to the Corvus Pharmaceuticals first quarter 'twenty 'twenty five 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.
Speaker Change: It is now my pleasure to turn the call over to Zac Cobo of real chemistry. Please go ahead Sir.
Zac Cobo: Thank you operator, and good afternoon, everyone.
Zac Cobo: For joining us today on the call.
Zac Cobo: Conference call is being webcast with the presentation slides, we encourage participants to join the webcast in order to view. The slides you can find the link to join the webcast on the Investor Relations homepage of the Corvus website.
Zac Cobo: Turning to slide two I would like to remind everyone that comments made by management today and answers to questions will include forward looking statements.
Zac Cobo: 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.
Zac Cobo: The risks and uncertainties described in Corpus its quarterly report on Form 10-Q for the quarter ended March 31, 2025, and other filings the company makes with the SEC from time to time.
Zac Cobo: The company undertakes no obligation to publicly update or revise any forward looking statements, except as required by law.
Zac Cobo: The agenda for the call is shown on slide three.
Zac Cobo: We will begin with a short overview of the first quarter financial results followed by a detailed review of the Socal that nib atopic dermatitis phase one data announced today and being presented at the society for investigative Dermatology annual meeting. This week. We will then provide a broader business update and then open the call for questions and answers.
Speaker Change: On the call from Corvus R. Dr. Richard Miller, Chief Executive Officer, Lastly, Chief Financial Officer, Jeff Archera, Chief Business Officer, and Dr. So rest of about my Boston, Vice President of clinical development.
Speaker Change: With that I'd like to turn the call over to likely life.
Speaker Change: Thank you Zack I will provide an overview of the key financial highlights from our first quarter.
Speaker Change: Research and development expenses in the first quarter 2025 totaled $7 $5 million compared to $4 1 million for the same period in 2024.
Speaker Change: The $3 4 million dollar increase was primarily due to higher clinical trial and manufacturing costs associated with the development of Socal at nib as well as an increase in personnel related costs.
Speaker Change: Net income for the first quarter 2025 was $15 $2 million, including a noncash loss of <unk> 5 million related to Angel Pharmaceuticals, our partner in China.
Speaker Change: In addition, we recorded a noncash gain of $25 $1 million from the change in fair value of course is warrant liability during the first quarter 2025.
Speaker Change: This compares to a net loss of $5 7 million for the same period in 2024, which included $8 2 million noncash gain related to Angel pharmaceuticals.
Speaker Change: Total stock compensation expense for the first quarter 2025 was $1.3 million compared to $7 million for the same period in 2024.
Speaker Change: As of March 31, 2025, Corvus had cash cash equivalents in marketable securities totaling $44 $2 million as compared to $52 million at December 31, 2024.
Speaker Change: In May 2025 holders of 8.945 million common stock warrants exercised all of their warrants in advance of the June 30 is 2025 exploration date, which resulted in cash proceeds to corpus of approximately $31.3 million.
Speaker Change: Richard Miller also exercised all of it is 559000 warrants all of the warrants were exercised at $3 50 per share.
Speaker Change: Based on our current plans, we expect our current cash including the warrant proceeds to fund operations into the fourth quarter of 2026.
Speaker Change: I will now turn the call over to Richard Who'll review, the so called Phase one data reported today and discuss other company progress and updates.
Richard Miller: Thank you Liz and good afternoon, everyone. Thank you for joining us today for our update call.
Speaker Change: I'm excited to be joining you from San Diego site of the society for investigative dermatology annual meeting or S. I D D.
Speaker Change: Data from our phase one trial with Socal isn't it in patients with atopic dermatitis will be presented in a poster later today and on Saturday in an oral session given by Dr. Albert you from the department of Dermatology.
Speaker Change: Inferred University Medical Center.
Speaker Change: We view the data is very encouraging with all treatment cohorts, demonstrating a favorable safety and efficacy profile compared to placebo.
Speaker Change: <unk> three data is especially interesting demonstrating earlier and deeper responses compared to cohorts one and two.
Speaker Change: In addition, the latest biomarker data from the trial continues to support the ITK inhibition mechanism of action, including the potential induction of anti inflammatory T regulatory cells.
Speaker Change: I will review the details of the data being presented at S. I D. Along with an overview of the ongoing trial and our future plans for the phase one trial and the planned phase II trial in atopic dermatitis.
Speaker Change: Slide six shows the design of the phase one clinical trial.
Speaker Change: Could you hold patients has met the hannifin ryka criteria and have moderate to severe atopic dermatitis, who have failed at least one prior systemic or topical therapy regimens. There are four cohorts that are sequentially enrolled and we have completed enrollment in the first three cohorts of the trial.
Speaker Change: 16 of subjects are enrolled in each cohort for placebo and 12 active.
Speaker Change: The study is double blind neither the patients nor the doctor knows the treatment assignment.
Speaker Change: Placebo and active tablets are indistinguishable.
Speaker Change: The company is not blinded and we were able to evaluate the data as the study progresses, we wanted to maintain the ability to or just or amend the trial based on available data as the study progressed. Since this is a novel agent with a mechanism of action not studied previously in this indication.
Speaker Change: Patients received study drug or placebo for 28 days and then they are followed for an additional 30 days off of therapy for a total of 58 days on study.
Speaker Change: We designed this study in this way to evaluate safety and efficacy while on the drug and to identify the possibility of persistent effects. After the drug is discontinued.
Speaker Change: The endpoints of the trial are safety and efficacy measured by easy eczema area and severity index scores and Iga investigator Global assessment.
Speaker Change: Each of the cohorts examines a different dosing regimen. The four cohorts. Our first 100 milligrams oral twice a day for a total dose of 200 milligrams per day.
Speaker Change: 200 milligrams oral once a day a different schedule, but also a total dose of 200 milligrams per day. The third cohort 200 milligrams oral twice a day for a total dose of 400 milligrams per day.
Speaker Change: The fourth cohort.
Speaker Change: 400 milligrams orally once a day.
These doses were selected based on our experience in T cell lymphoma patients.
Speaker Change: Have shown that these doses resulted in significant or complete ITK target occupancy to.
Speaker Change: 200 milligrams twice a day is the dose we are evaluating in our ongoing phase III registration lymphoma trial.
Speaker Change: The next slide shows the characteristics of the 48 patients enrolled and treated in cohorts, one two and three.
Speaker Change: Placebo in Socal it groups are shown as well as the combined cohorts.
Speaker Change: There are a few characteristics to point out.
Speaker Change: The mean baseline easy scores in cohort three for both the Socal at Nib and placebo groups was about 27% to 28 significantly higher than cohorts, one and two which were in the range of 17 to 20.
Speaker Change: This indicates that cohort three patients had worst disease at baseline.
Speaker Change: <unk> with this is that cohort three patients also had a higher percentage of patients who failed prior systemic therapies. In fact, two treated patients had disease that was refractory or resistant to depicts it.
Speaker Change: There was a high percentage of African Americans in all groups such patients are reported to have worse prognosis.
Speaker Change: Generally the socal at Nib in placebo patients are very well balanced with regard to patient characteristics.
Speaker Change: Cohort three placebo patients are younger but the age is not a prognostic variable.
Speaker Change: Now, let's move on to the efficacy results, which are shown in the table on slide eight.
Speaker Change: This table shows the results at day 28 for patients in the so Paulo.
Speaker Change: And placebo groups co.
Speaker Change: Cohorts, one and two are combined since the characteristics and results were very similar.
Speaker Change: The left side shows results for the combined cohorts, one and two and the right side shows the results for patients in cohort three that have completed 28 day follow up.
Speaker Change: <unk> active and for placebos for additional patients in cohort three receiving active drug have completed day 15 follow up but have not yet completed the 28 day follow up.
Speaker Change: For cohorts, one and two the mean reduction in easy score in the placebo group is 36% and 54, 6% for the so-called at the Nib group, an absolute difference of 24.0%.
Speaker Change: For cohort three the median percent reduction in easy score in the placebo group is 42, 1% and is 71, 1% for the so-called at Nib group, an absolute difference of 29.0%.
Speaker Change: Looking at easy 50, we see that both placebo and <unk> treated patients often achieve easy 50.
Speaker Change: The situation is much different for easy 75, <unk> 90, and Iga zero or one which are the endpoints considered to be clinically meaningful.
Speaker Change: No placebo patients reached easy 75, easy 90, or Iga zero or one.
Speaker Change: In the so-called group for cohorts, one and 229% achieved EZ 75, and 4% achieved easy 90, well I'm in cohort, 363% achieved easy 75, and 13% achieved easy 90.
Speaker Change: 21% of the patients in the cohort one and two so called it named groups achieved Iga zero or wanted while in cohort, 325% in the so called Internet group achieved Iga zero or one.
Speaker Change: The next slide shows the kinetics of response for the patients treated with Socal isn't it in each of the cohorts one two and three and the combine the placebo patients from all three cohorts.
Speaker Change: The Orange line represents placebo.
Speaker Change: You can see that cohorts, one and two represented by the Blue and Red lines, respectively begin to separate from placebo at day 15 and show continued separation at day 28.
Speaker Change: This separation is maintained during the 30 day post treatment period.
Speaker Change: The curves for cohort one and two are nearly overlapping indicating that there are no differences in the twice per day compared to the once per day dosing regimen.
Speaker Change: It appears that QD dosing is possible for this drug.
Speaker Change: The Green line, which represents cohort three shows earlier and deeper separation from placebo at day eight with easy score improvement continuing through the 15 and 28.
Speaker Change: Cohort three data includes all 12 <unk> treated patients in the cohort three a day 15, and then for <unk> patients at day 28, as there are for patients that have not yet reached their 28 day follow up.
Speaker Change: Of note those four patients in the so-called isn't a group are demonstrating results at day 15 that are consistent with the other patients. So we should expect that trend to continue to day 28.
Speaker Change: All placebo patients have reached the day 28 follow up.
Speaker Change: I would like to point out that the downward slope of the curves and all treatment cohorts at day 15 to 28 suggests that longer treatment duration could potentially deepen responses further.
Speaker Change: On Slide 10, we show the same analysis as the prior slide but with the data for cohort one two and three combined shown in the Blue line.
Speaker Change: This is the data from all patients separation from placebo begins by day 15, and by day 28, It is statistically significantly better than the placebo with a P equal to 0.03.
Speaker Change: The next slide summarizes the efficacy for each treatment cohort and for the combined placebos.
Speaker Change: No placebo achieved EZ 75, or Iga zero or one <unk>.
Speaker Change: Significant differences are seeing for the treatment groups compared to placebo with cohort three appearing to be better than the other cohorts.
Speaker Change: Data from the combined Socal lithium cohorts is statistically significantly better than placebo.
Speaker Change: Now, let's review the safety.
Speaker Change: As shown on this slide there were no significant safety issues observed with Socal at nib with no differences between treatment and placebo groups.
Speaker Change: Only one treatment related adverse event was seen in a patient receiving so-called at nib, a grade one nausea, no clinically significant laboratory abnormalities were seen.
Speaker Change: The total treatment experience with so-called at Nib now Intel involves over 100 patients with T cell lymphoma, or atopic dermatitis, representing approximately 9000 patient treatment days in our lymphoma trial. Some patients had been on continuous daily therapy for up to two years.
Speaker Change: Based on these results we have amended the phase one trial protocol as outlined on slide 13.
Speaker Change: At the bottom of this slide in Purple, we showed that the previously planned cohort four is being replaced with an extension cohort that will evaluate an additional 24 patients at the 200 milligram twice per day dose given for eight weeks with an additional 30 days.
Speaker Change: Follow up without therapy.
Speaker Change: Based on our studies of occupancy and pharmacokinetics, we determined that cohort four would not likely provide more useful information and by replacing the cohort with a new cohort, we don't expect to lose any time.
Speaker Change: The 24 patients will be randomized in a blinded fashion one to one with placebo 12 active and 12 placebo.
Speaker Change: We believe this amendment gives us the opportunity to evaluate the potential for greater efficacy with longer treatment duration, we anticipate data from the extension cohort will be available in the fourth quarter of this year.
This additional experience should help optimize the design of our phase II trial, which we are working on in parallel and remain on track to initiate before the end of this year.
Speaker Change: Phase two will likely evaluate different doses and durations of therapy, including once per day administration of the drug.
Speaker Change: In conclusion.
Speaker Change: We continue to be encouraged by the results from the trial, which show a favorable safety and efficacy profile with a convenient oral tablet.
Speaker Change: Key highlights from the data include.
Speaker Change: All three cohort showed a significant reduction in easy score at 28 days of treatment with clear separation from placebo.
Speaker Change: Cohort three with 200 milligram twice per day dose showed earlier and deeper responses in cohort one and two data that is consistent with our pharmacokinetic analysis.
Speaker Change: Cohort, one and two results evaluating 200 milligram once per day versus 100 milligram.
Speaker Change: Twice per day dosing showed no differences in activity, suggesting that QD dosing is possible.
Speaker Change: Post treatment all three cohorts showed a sustained benefit for 30 days potentially due to increase T Reg cells.
Speaker Change: No rebound events, such as seen with JAK inhibitors was observed.
Speaker Change: The safety profile across all three cohorts.
Speaker Change: <unk> is very well tolerated based.
Speaker Change: Based on the results to date, we are adding a new extension cohort that will evaluate longer 56 day or eight week treatment duration.
Speaker Change: More broadly the safety mechanism of action and other properties suggest that so call it and it could be an important new treatment for a broad range of immune diseases.
Speaker Change: Yeah.
Speaker Change: Now for a brief business update for the quarter.
Speaker Change: We continue to enroll patients in our Registrational phase III trial of so called <unk> in patients with relapsed peripheral T cell lymphoma driving towards interim data in late 2026.
Speaker Change: The first patient has been treated in our phase II trial of so-called at nib in patients with ALS or autoimmune only for proliferative syndrome depend.
Speaker Change: Depending on enrollment trends it is possible we could see initial data from the phase II <unk> study in late 2025 or early 2026.
Speaker Change: In closing the Socal index results in atopic dermatitis further underscore it's broad potential for a range of oncology and immune disease indications. This includes our clinical programs for PTC L. Atopic dermatitis and Alps, our planned study for solid tumors and a long list of immune diseases that we.
Speaker Change: Have the potential to address with so-called isn't it.
Speaker Change: Or our next generation ITK programs.
Speaker Change: We are delighted with the early exercise of warrants.
Speaker Change: Announced today, which results in an additional $31 million and enables us to advance <unk> on multiple fronts, including key data from the next 24 patients.
Speaker Change: In the atopic dermatitis trial, which we expect to have in the fourth quarter of 'twenty 2025.
Speaker Change: Current cash takes us to late 2026.
Speaker Change: We look forward to providing updates on our programs in the coming quarters I will now turn the call over to the operator for a question and answer period operator.
Speaker Change: Thank you ladies and gentlemen, we will now begin the question and answer session should you have a question. Please press the star followed by the one on your Touchtone phone.
Speaker Change: You will hear a prompt up your hand has been raised should you wish to decline from the polling process. Please press the star followed by the number too.
Speaker Change: If you are using a speaker phone please lift the handset before pressing any keys.
Speaker Change: One moment. Please for your first question.
Speaker Change: Yeah.
Speaker Change: Your first question comes from the line of Aydin Jose nodes from Ladenburg. Please go ahead.
Speaker Change: Hi, good afternoon, everyone, congratulations surge, which is a great data.
Speaker Change: Couple of questions on my end so since like your cohort three easy 75 data at week four beats as it takes them Cid at week 16, and it also seems that your data is actually getting closer to JAK inhibitors. Then it makes sense. So do you think eventually as Taco Lipnick would be US ahead of the pig.
Speaker Change: Sent and competing for JAK inhibitors.
Speaker Change: Just curious in your opinion.
Speaker Change: Thank you for the question as well.
Speaker Change: First of all the cohort three is a small sample size. So we have to.
Speaker Change: To put that in a little bit perspective, but yeah, I think that our data at four weeks is competitive with other agents that are approved for.
Atopic dermatitis I do see with the safety and convenience that we have with an oral tablet that this could become an early early.
Speaker Change: Early lines of systemic therapy.
Speaker Change: You know we have a lot more work to see exactly where that fits in but.
Speaker Change: I think that.
Speaker Change: The work we've done here.
Speaker Change: It shows a novel mechanism.
Speaker Change: Which.
Speaker Change: <unk> has the potential to be used early on in the therapy of atopic dermatitis.
Speaker Change: Thank you I appreciate that another pushing their habits in terms of the efficacy curve sudden again looking at JAK inhibitors from Jackson I think its pluto's, it's a week eight and based on the mechanism of action, where do you think can this potentially plethora or was it is it going to be a week eight.
Speaker Change: 12, 16 any thoughts on this.
Speaker Change: Well, yeah, so look at it.
Speaker Change: We're struck by the fact that the curves are still decreasing from 15% to 28 days at a pretty steep slope and then it flattens out as soon as you stop the drug.
Speaker Change: So the question I mean it begs the question. If you were to continue therapy would you get deeper better responses and so we want to test that in in our amended protocol.
Speaker Change: We also have examples in our study of patients who were responding we're continuing to get better at day 28, including some of the very sick ones. They were getting better. They work by day 28, and we had to stop the drug by protocol. So it really does raise the question Nathan raised by their physicians Gee why.
Speaker Change: I can't we continue this since they were improving on the therapy.
Speaker Change: Thank you. Thank you very helpful and the last question is there is a significant jump in easy efficacy between cohort two and cohort three and obviously as I mentioned cohort three had even more severe patients. So how do you explain such a sharp jump in efficacy and again, it's small.
Speaker Change: Numbers and such but just curious on your thoughts on this.
Speaker Change: Well, we have more drug it's twice the drug cohort three is double the dose total daily dose compared to cohorts, one and two so that the dose of drug has been doubled and very very careful analysis. We did from our lymphoma patients shows that when you raise the dose to that level you.
Speaker Change: Pretty much have occupancy 24 hours a day.
Speaker Change: And that could be that could be important.
Speaker Change: So it makes a lot of sense.
Speaker Change: We ended up at 200, PID and our lymphoma study.
Speaker Change: After carefully looking at a lot of different dose levels. So this all makes perfect sense and listen even early on I think back in December January when we were talking about this we always said we expected the third cohort would be.
Speaker Change: Would be better than it is.
Speaker Change: No I think it's still an open question, whether 200 tid versus a maybe 400 once a day.
Speaker Change: Be equal so we need to ultimately test that and that's something we're thinking about in our phase II trial design.
Speaker Change: Got it thanks, so much Tricia congratulations again with this great data.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Yeah.
Speaker Change: Thank you. Your next question comes from the line of Greg Savada Vision from Mizuho Securities. Please go ahead.
Speaker Change: Oh, great. Thanks for taking my questions will extend our congrats on the data in atopic dermatitis as well I was.
Speaker Change: Wanting to ask about the modification to the phase one study and the.
Speaker Change: Extended.
Speaker Change: Duration cohort.
Speaker Change: I think I completely understand the logic of wanting to treat longer I think I heard and I might have misunderstood, but I think I heard that you might consider adding a QD dose.
Speaker Change: And that and so if.
Speaker Change: If that is indeed true.
Speaker Change: And given the comments that.
Speaker Change: The 400, QD dose may not be all that differentiate I'm just wondering what that potential QD dose would be if you were to test that in the extended duration cohort. Thanks.
Speaker Change: The extended duration is 24 patients 12 active 12 placebo.
Speaker Change: One dose.
Speaker Change: A single dosing regimen will be studied 200 <unk> PID.
Speaker Change: Thank you what I mentioned is yeah yeah.
Speaker Change: Okay.
Speaker Change: So it does seem like optimally at least as of today 200 milligram B I D seems to be the optimal dose across both your oncology and at.
Speaker Change: At least atopic dermatitis indications.
Speaker Change: Yes.
Speaker Change: That's correct.
Speaker Change: Okay.
Speaker Change: Thank you for that and then if I could ask just going back to the data that you shared today if.
Speaker Change: If we look at the data in cohort two the difference there was a difference in what was seen.
Speaker Change: On at least easy 75 with numbers coming down and I'm I'm going to assume that's because of the extra patients that you included you didn't really see them achieve.
Speaker Change: Easy 75, and so as I'm thinking now about the remaining four patients that have not been reported out yet because I don't think they've finished a follow up.
Speaker Change: <unk>.
Speaker Change: Any thoughts on what their potential contribute contribution could be to the efficacy scores that you are seeing as of today. Thanks.
Speaker Change: So I'm not totally sure what youre, saying that the numbers are for the.
Speaker Change: 200, QD are a little bit lower than we showed in January you are saying.
Speaker Change: <unk> patients.
Speaker Change: Yeah, Okay first of all again small numbers, but.
Speaker Change: A couple of those patients were easy 72, and <unk> 68, I mean, some of this is really very close so I think it was really there was really no substantive difference.
Speaker Change: And if you look at our cohort three if you look at the EZ scores in the eight patients at day 15 in the four that are also at day 15 third darn close.
Speaker Change: And you can see that actually if you look at the standard error bars on the green are very tight.
Speaker Change: Yeah.
Speaker Change: Okay, maybe one last one I'll sneak in it should be a short easy question to answer when would you expect to share the complete cohort three data from all 12 patients.
Speaker Change: Yeah.
Speaker Change: Yeah.
Speaker Change: I think we could share that.
Speaker Change: Press release, probably in a month or two.
Speaker Change: Okay.
Speaker Change: Thank you so much and congratulations again on the data.
Speaker Change: Okay.
Speaker Change: Thank you.
Speaker Change: Your next question comes from the line of Lee <unk> from Cantor. Please go ahead.
Speaker Change: Hey, Congrats on the data is Wow I may be a couple of questions from us.
Speaker Change: First just on the placebo group when I looked at the easy change from baseline looks like.
Speaker Change: This group also went down and Didnt really rebound so I guess the question is.
Speaker Change: Let's see Oh, you flag canfor pulp compared to other trials.
Speaker Change: Uh huh.
Speaker Change: Let's go to factor them in by a handful of patients.
Speaker Change: So there were placebos that rebound and get worse in fact, you can eat.
Speaker Change: If you look at the standard error bars on the placebo, you'll see that they are quite broad and.
Speaker Change: And so there were a couple of patients that that in fact did get worse.
Speaker Change: And.
Speaker Change: Is this standard.
Speaker Change: Actually I think our placebos behave.
Speaker Change: Pretty pretty much like others I mean, some recent studies have had even more.
Speaker Change: We have really haven't seen that. One of the things we did and didn't really have time to go into this presentation is we track the easy scores. If you look at the graphs on slides 9 and 10 screening to baseline, that's a period of about two weeks.
Speaker Change: That's the time the patient comes in and goes through the necessary testing to make sure they're eligible And so easy scores are done at the beginning of that and of course before they go on treatment and note how stable they are for all the groups So this is a this is a tribute to the physicians and our staff
Speaker Change: in the training in terms of easy scores, and how stable they were. [inaudible]
Speaker Change: But the minute you start taking a pill, there is a placebo effect, clearly, and some of those placebo's improve.
Speaker Change: Reach EC75 or IG01. But keep in mind, those studies are done longer. So they're there you're on study for three months or six months or longer. So the longer you're on study, the more there is a chance that a placebo could have an improvement and reach that. [inaudible]
Speaker Change: Okay, I'm doing good. Yeah, thanks for clarifying that. And then just curious, if you see any differential response in patients with or without prior systemic treatment.
Speaker Change: Ah, too early to talk about that, but we had in cohort 3
Speaker Change: Two patients, one was completely refractory to de-pixen, had a baseline easy in the mid-40s.
Another...
Speaker Change: Okay, let me just talk about that patient first. That patient had failed to fix it, didn't respond at all. Jack inhibitor and methotrex fate didn't respond to any of that, went on our drug and improved significantly.
Speaker Change: was improving throughout the study. But again, we had a stop at day 28. Physician wanted us to continue, of course, but we couldn't [inaudible]
The Second Patient,
was a patient with easy and high thirties.
Speaker Change: was on depictions for a while, responded to that, then progressed again, was put on depictions again, did not respond, did not respond at all. When an art drug had an easy 90.
Speaker Change: Achieved an easy 90 on our drug. So that's n equals 2. So I don't know if responder versus non-refractory or resistant versus no prior systemic therapy. I don't know what the prognostic significance of that is because we only have a couple of those patients. But I would suggest that given our mechanism of action is not overlapping with those agents, I would see no reason and why there would be any difference.
Speaker Change: between someone who had a jack or a depiction or not. So I think all of this is falling into line, very consistent, you know, based on what we've learned in lab, what we've learned in animal models, and frankly what we've learned from our lymphoma studies.
Lee, Comrade again.
Speaker Change: Thank you. Your next question comes from the line of Jeff Jones from Open Himer. Please go ahead.
Jeff Jones: Good afternoon guys and congrats again on the really outstanding data here.
Um.
Richard Miller: Richard, you've talked a little bit about receptor occupancy. Have you looked in these patients through cohort three at receptor occupancy at all to see if there might be differences in what you've seen with the T-cell lymphoma patients versus A-D patients?
Jeff Jones: We have not looked in these patients because we've done so many lymphoma patients and this is just chemistry, Jeff, if you have a concentration of a certain level, you're going to bind that receptor.
Richard Miller: It's a covalent drug, and we know what that level is, by the way, it's 300 nanograms per
Richard Miller: In looking at this data, obviously the EZ75 numbers came down somewhat from what you initially reported from a subset of the cohort two patients.
and I believe that was around 57% EZ75.
Richard Miller: Clearly, the drugs are highly active, and I guess it's just a question. What particular is giving you confidence in the dose effect you're seeing between cohort two and three, given the small numbers at this point?
Richard Miller: So, first of all, again, look at the kinetic curve on 9. Look at slide 9 and the kinetic curve response. Not only is there a deeper response with it.
Richard Miller: with cohort three, but it's earlier. We do know there's more receptor occupancy and we had sicker patients in cohort three.
Richard Miller: I mean substantially sicker patients. And again, if we look at the cohort 3 day 15 data it's
Richard Miller: So that gives us confidence. And with regard to the cohort to changing, again, very small number. And, you know, EZ75 is, is, is
Richard Miller: It's important, since it's somewhat arbitrary, as I mentioned earlier, a couple of the follow-up patients where subsequent patients had, you know, easies in the low 70s didn't quite make it and that's just luck at the drawer. The fact of the matter is that at 28 days
Richard Miller: Substancell number are responding. And in fact, I would even argue that in the cohort three, even if the next respond, if the next set of patients didn't respond, you still have what a 50% to easy 75, which is a pretty good result. [inaudible]
Richard Miller: Now, I appreciate that Richard, and I think the kinetics really help with that story and the fact that all the patients are through day 15.
Speaker Change: here. And I guess one last question just on the runway guidance that you gave. Can you tell us what trials are included in that? Because you guys have got a lot on your plate right now.
So, let me deflect that to Leif. Leif, can you?
Sure, so it-
Includes the trials that Richard laid out, one. [inaudible]
One of the extension cohort.
Speaker Change: Part of our Phase 1 AD trial, starting the Phase 2 AD trial, continuing with our Phase 3.
Speaker Change: Lymphoma Trial, and at the end of the year starting a solid tumor trial, a small phase one trial. It could all of those trials.
Great. Thank you guys very much and congrats again.
Okay, maybe we have-
Time for one more question or... [inaudible]
Operator
Yes, we have one more question, comments.
Speaker Change: Coming from the line of Roger Song from Jeffrey, please go ahead [inaudible]
Okay.
Okay, great. Wait.
But you mention something for-
Speaker Change: Phase 2, you're considering QD as one of those cohorts. Would that be 400mg or lower or higher? And then if it's 400mg, what's the seating of those in terms of the safety profile? And I have a quick follow-up. Thank you.
Speaker Change: All right, so first of all remember in lymphoma we went up to 600 milligrams BID and didn't see any DLTs or maximum tolerate dose was not reached.
Speaker Change: So Roger, we have not finalized the Phase 2 trial yet, so I'm a little hesitant to give you exactly what the designer that is. What it all have is...
Speaker Change: Two, at least two active dose groups, and one you want to make lower, hopefully that has lower response, one you want your real dose, and then of course we'll have placebo.
Speaker Change: So, in 200 milligrams BID will certainly be one of the active doses. So then I think that we would either look at 200 QD, maybe that's one dose level, or maybe the 401s a day.
Speaker Change: Alright, so we have not finalized that yet, and part of the reason for doing more patience.
Speaker Change: I am part of what we're trying to do is confirm this 200 BID, get more measurements, look at more things. I should also mention, I didn't include this in the presentation but if you look at our poster and the presentation Dr. Chiou will make on Saturday.
Speaker Change: There are changes that are emerging in the cytokines and in the T-reg cells and cohort 3 is superior. The changes, I should let me say it this way, the cohort 3 changes are more dramatic.
Speaker Change: Got it, yeah, that's, yeah, okay, that's very helpful, maybe just quick last one.
Speaker Change: Understanding your cashier in ways covering all the phase two and then the idea or the other indications. Just curious about the thinking about the partnership. Do you would you speaking, you know, the discussion even before the phase two, thank you.
Speaker Change: No, we're going to blast ahead on our own. We recognize, however, that
and, you know, move forward.
We're not dependent on any partners.
Great. Thank you. Thank you, George.
Speaker Change: All right. Thank you. I think that there's one more question in there. Okay, we'll take another question.
We have one last question coming from the line of Sean Lee from HG, Wayne Wright. Please go ahead.
Speaker Change: Hey, good afternoon guys, and congrats on the exciting results, and thanks for taking my question
But just that's why...
Speaker Change: Because we're looking at the almost non-existent side effects of this drug, what are your thoughts on potential combinations either for AD or other indications? Thanks.
Speaker Change: Lots of people are bringing up that question. Thank you for asking it because it has a non-overlapping mechanism with other drugs and because of its safety and because it's oral and conveniently administered. There is an opportunity to combine with other agents and I mean there's a big list of agents.
Speaker Change: inhibitors, the anti-IL-13s. So I think that there's a lot of opportunities there, but for now we're going to be plowing ahead with monotherapy.
Okay, thanks for that.
Speaker Change: Alright, I think that concludes our conference call. Thank you all so much for participating. We look forward to providing updates on our programs as we move forward. Thank you.
Thank you, everyone, for participating.