Medicenna Therapeutics Corp. (MDNA) CEO Fahar Merchant on Q2 2023 Earnings Call Transcript

Medicenna Therapeutics Corp. (NASDAQ:MDNA) Q2 2023 Earnings Conference Call November 4, 2022 8:30 AM ET

Company Participants

Dan Ferry - IR, LifeSci Advisors

Fahar Merchant - President & CEO

Liz Williams - CFO

Conference Call Participants

David Martin - Bloom Burton

Catherine Novack - Jones Search

Operator

Hello and welcome to the Medicenna Therapeutics' Fiscal Second Quarter Earnings Call. All participants are in a listen-only mode. There will be a Q&A session at the end of the prepared remarks. Please be advised this call is being recorded at the company's request.

I would now like to turn the call over Dan Ferry of LifeSci Advisors. Please go ahead.

Dan Ferry

Thank you, operator and thank you all for participating in today's conference call. This morning, Medicenna issued a press release providing financial results and corporate updates for the quarter ended September 30th, 2022. If you have not yet seen the press release, it is available on the Investors page of Medicenna’s website.

Before we begin, I would like to remind you that certain statements and information shared during this call, constitute forward-looking information within the meaning of applicable securities laws. All statements other than statements of historical facts shared during this call and that relate to the future operations of the company, and other statements that are not historical facts, including statements related to the clinical potential and development of MDNA11, preliminary clinical data, cash runway, the presentation of additional data, and other milestones are forward-looking statements that are subject to risks and uncertainties. There could be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements.

Important factors that could cause actual results to differ materially from the company's expectations, include the risks detailed in the Annual Information Form, Management's Discussion and Analysis, and Form 20-F of the company, and in other filings made by the company with the applicable securities regulators from time-to-time in Canada and the United States.

Listeners are cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the company.

You are cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management, may prove to be incorrect, and actual results may differ materially from those anticipated.

Forward-looking statements contained in this conference call are expressly qualified by this cautionary statement. Except as required by law, we do not intend and do not assume any obligation to update or revise publicly any of the included forward-looking statements, only as expressly required by Canadian and United States securities law.

Speaking on today's call will be Medicenna's President and Chief Executive Officer, Dr. Fahar Merchant; and Chief Financial Officer, Liz Williams.

I will now turn the call over to Fahar to begin. Fahar?

Fahar Merchant

Thanks Dan, and good morning, everyone. Today's call will focus primarily on our September clinical update of new data from the Phase 1/2 to ABILITY study of MDNA11, our beta-only long-acting IL-2 super-agonist. These data came from the early and mid-stage cohorts in the trials dose escalation phase.

While this portion of the study is designed primarily to evaluate safety and pharmacokinetics and pharmacodynamics in order to determine a recommended Phase 2 dose, we have nonetheless have clear evidence of MDNA11's monotherapy efficacy in tumors that are typically highly resistant to immunotherapy, an important finding at this early juncture of the trial.

This evidence includes a confirmed partial response in a metastatic pancreatic cancer patient in the trial's fourth cohort, which is the first employee the set step-up dosing strategy we will be utilizing going forward.

You may recall that on our last earnings call, we spoke about this patient having an unconfirmed partial response, as well as our eagerness to gain confirmation with a subsequent scan.

With this confirmation in hand we can now proudly say that we have demonstrated MDNA11 single agent potential in a notoriously difficult-to-treat cancer, thereby achieving one of the ABILITY study's core objectives.

To fully understand the significance of this result, it's important to have context on the patient in which it was achieved, as well as their treatment history and pancreatic cancer more broadly. This patient entered ABILITY with pancreatic cancer that had metastasized to the liver despite having previously received surgery, and treatment with three lines of systemic therapy.

These therapies included six different chemotherapies, as well as treatment with a checkpoint inhibitor, all of which were ultimately unsuccessful or not tolerated by the patient. That these lines of therapy were unsuccessful is unfortunately, not surprising, as pancreatic cancer is well known to be one of the most aggressive types of cancer with a five-year survival rate of only 11.5%, according to the US National Cancer Institute.

Additionally, pancreatic cancer rarely responds to single agent immunotherapy. In fact, we are not aware of any published data showing efficacy with systemic administration of an IL-2 monotherapy in pancreatic cancer, we therefore view MDNA11's ability to generate a confirm partial response in a such a heavily pretreated and stage patient as an important finding that differentiates it as a potentially best in class is to agonist and bodes well for the program moving forward.

In addition to the confirm partial response, we have observed tumor control in four other patients in the ABILITY study's low and mid-stage dose escalation cohorts for an overall tumor control rate of 36%.

Patients achieving tumor control included one with metastatic melanoma, as well as one with non-clear cell renal cell carcinoma, and two with sarcomas. Like pancreatic cancer, sarcomas and non-clear cell renal cell carcinoma, but typically highly resistant to immunotherapies.

When looking at how abilities data have matured over time, they have also notably seen evidence suggesting durable anti-cancer activity with MDNA11 monotherapy, administered via IV infusion once every two weeks. This has come from the aforementioned pancreatic cancer patient as we see continued deepening of tumor reduction over each of the last three scans leading up to the confirm partial response.

Additional evidence of durability comes from the metastatic melanoma patient achieving tumor control, as this individual has been on study for more than a year, while maintaining stable disease, having initially started treatment at the low dose.

Collectively, these anti-tumor activity data from ABILITY's early and mid-stage cohorts, a full overview of which can be found in a streamer spot online in our corporate deck provide a robust demonstration of MDNA11 single agent potential in advanced solid tumors, unresponsive to establish treatments, including 79% of the patients with prior failed checkpoint inhibitor therapies.

Adding to our enthusiasm for these results are the trials pharmacodynamic data, which further confirm a mechanistic rationale for MDNA11's differentiated and potent anti-tumor activity, while underscoring its best-in-class potential. These results show MDNA11 driving multi-fold increases in anti-cancer immune cells that are greater than those achieved with competing agents administered at equivalent IL-2 doses.

Moreover, MDNA11 has not been shown to stimulate pro tumor immune cells or eosinophils, which are linked to one of the most serious side effects of the only approved IL-2 two therapy, Proleukin.

These favorable pharmacodynamic results are a result of MDNA11's unique design. This design provides MDNA11, with enhanced affinity for IL-2 receptor, beta which is important for anti-cancer immunity and no affinity for IL-2 receptor alpha, the stimulation of which is associated with pro-tumor immune suppression and toxicity.

Together with the inclusion of an augment protein that provides half life extension and improves localization in the tumor, the tumor draining lymph nodes, and the lymphatic system where cancer fighting immune cells are resident and primed for recruitment to attack the tumor.

This unique binding profile, together with highly differentiated mechanism fuels our belief that MDNA11 has the potential to become a best-in-class therapy that overcomes the major shortcomings of Proleukin and other competing programs. This hypothesis is already being borne out by the maturing ABILITY data I just discussed.

Looking forward for the ABILITY study, we expect to present additional PK/PD data, as well as detailed safety data from the first four dose escalation cohorts at the upcoming [Indiscernible] meeting next week.

With regards to subsequent readouts on anti-tumor activity data, we remain optimistic that the results of future cohorts will provide additional evidence of monotherapy efficacy as we continue to dose escalate. This optimism is fueled by the encouraging disease control rate, despite the Nth stage nature of these advanced tumor types.

The safety profile to-date is encouraging with no dose limiting toxicities, dose interruptions, dose escalations, nor treatment discontinuations due to safety issues observed to-date. Enrollment in the trial's fifth dose escalation cohort is currently underway.

We expect to report initial anti-tumor activity data from this cohort, alongside a broader update from all of the trials, dose escalation cohorts in the first quarter of 2023.

Based on what we see from this fifth dose code, along with a broader update, we will be in a position to make a strategic decision whether or not to advance to the sixth dose cohort.

Given the positive safety profile we have seen so far and our confidence in the differentiated aspects of MDNA11, we are committed to find the optimal dose beyond cohort five if needed.

Upon the determination of a recommended Phase 2 dose during dose escalation, we expect to advance to the trial's single agent dose expansion phase, where early activity data expected in mid-2023.

In parallel, we plan to work to initiate the trial's combination, which is designed to evaluate MDNA11 together with the PD-1 checkpoint inhibitor Keytruda. This portion of the study is enabled by our clinical collaboration with Merck, which we are pleased to begin last quarter.

We and Merck will establish a joint development committee to optimally advance ABILITY's combination arm from which early anti-tumor data are expected in late 2023.

Though the expected timing of this upcoming readouts on anti-tumor activity represent a brief delay compared to prior guidance, we believe that taking the extra time necessary to recruit and optimize patient population in the current and future cohorts will allow us to potentially increase the impact of the data from these those cohorts from a scientific and value creation perspective.

Lastly, before handing the call over to Liz, I will remind all listening that enrollment in ABILITY's single agent expansion in combination arms will focus on a select number of tumor types to best inform our development strategy.

By generating additional evidence of MDNA11 anti-tumor activity in key indications, we believe we can accelerate its development and bring the company to a key value inflection point.

And with that, I will complete this section of today's call and hand it off to Liz. Liz?

Liz Williams

Thanks Fahar and thanks to all listening. Before I begin, I'll note that all references are in Canadian dollars unless otherwise stated. As of September 30th, 2022, Medicenna had cash equivalents and marketable securities of CAD40 million. This includes the net proceeds from our August financing, which added several new health care focused institutional investors to our shareholder base.

Based on our projections, our current cash resources are sufficient to fund our operations into Q2 calendar 2024. This takes us through multiple important clinical readouts and the completion of the ABILITY study including both its monotherapy and combination arms.

Net loss for the quarter ended September 30th 2022 was CAD0.9 million or CAD0.01 per share compared to a net loss of CAD8.2 million or CAD0.15 per share for the quarter ended September 30th, 2021. The significant decrease in net loss for the quarter ended September 30th, 2022 compared with the quarter ended September 30th, 2021 was primarily a result of a foreign exchange gain of CAD1.9 million on our U.S. dollar cash balances, due to the strength of the U.S. dollar during the current quarter. A non-cash gain of CAD1.8 million related to the change in valuation of a non-cash warrant liability associated with the August 2022 financing, as well as a reduction in R&D expenses in the current year period.

Research and Development expenses of CAD2.4 million were incurred during the quarter ended September 30th, 2022 compared with CAD6.3 million incurred in the quarter ended September 30th, 2021. The decrease in research and development expenses in the current fiscal year quarter is primarily attributed to costs associated with the development of MDNA11 incurred in the prior year, including GMP, manufacturing and IND enabling studies, for which no comparable expenses were incurred in the current year. The reduction in MDNA11 development expenses was partially offset by higher clinical costs in the current year period.

General and administrative expenses of CAD2.4 million were incurred during the quarter ended September 30th, 2022 compared with CAD2 million during the quarter ended September 30th, 2021.

The increase in general and administrative expenses is primarily attributed to one-time transaction costs of CAD.7 million related to the warrant liability derivative associated with the August 2022 financing, for which there was no comparable expense in the prior year period.

For further details on our financials, please refer to our financial statements and management's discussion and analysis which will be available on both SEDAR and EDGAR, respectively.

With that, I'll now turn the call over to Fahar for some closing remarks.

Fahar Merchant

Thanks, Liz. In closing, I'd like to stress the significance of our recent accomplishments and reiterate my enthusiasm for the future of our MDNA11 program.

With our recent financing, as well as the clinical trial collaboration and supply agreement with Merck, we have added strength to our shareholder base and the resources needed to ensure the ABILITY study is fully funded through multiple important milestones and to its completion.

We also generated additional data from ABILITY's dose escalation cohorts, which added to a robust body of evidence supporting MDNA11's potential as a best-in-class therapy.

This data show MDNA11 displaying a pharmacokinetic and safety profile that overcomes Proleukin major shortcomings, and a pharmacodynamic profile that thus far appear superior to other IL-2 variants in development.

Moreover, despite ABILITY's dose escalation phase being designed primarily to evaluate safety and pharmacokinetics rather than efficacy, we have seen promising signs of durable monotherapy activity at the low and mid dose levels. These signs include a confirmed partial response in pancreatic cancer and additional instances of tumor control in patients with difficult-to-treat tumors that have been unresponsive to established therapies.

We are therefore optimistic that we will see further evidence of MDNA11's efficacy as we evaluate higher doses and focus in enrolment on patients that better reflect its target addressable population in future cohorts. The trial's progress is expected to provide a consistent cadence of potential catalysts over the coming quarters and we look forward to its continued advancement.

And with that, I would like to extend my thanks to all those who helped us reach this point, including our employees, investigators, shareholders, and especially, the clinical trial participants.

We'll now open the lines for questions. Operator?

Question-and-Answer Session

Operator

And at this time, we will be conducting a question-and-answer session. [Operator Instructions]

And our first question comes from the line of David Martin with Bloom Burton. Please proceed with your question.

David Martin

Hi. Good morning Fahar and Liz. First question, I'm wondering how many patients in cohort 5 have escalated to the 90 dose and if DLTs or SAEs occurred? Do you know about them generally immediately?

Fahar Merchant

Hi, David. Thank you for your question. Yes, we are made aware of DLTs, SAEs, as soon as the site has determined it to be the case. And they would notify us pretty much immediately and we will be made aware of it right there and then. So yes, that's the protocol.

With respect to how many patients we haven't disclosed that in terms of the data on cohort 5. And therefore, we're sort of provide updates as we collect more data. And once we have completed enrollment of that particular cohort, and completed a step up dosing onto the target dose of 90 micrograms in all the patients.

David Martin

Okay. Second question. You mentioned the brief delay milestones, I didn't really see a delay versus what I was expecting. But nonetheless, how will -- you mentioned that's because you want to optimize the patient's going forward? So I'm wondering how will the patients in cohort 5 and then the expansion in the combo studies differ from the earlier patients you've enrolled in the study? What does optimizing mean just limiting the tumor types?

Fahar Merchant

Good question. So if you recall, when we were enrolling patients in the earlier cohorts, we had not set the, what we call the baseline lymphocyte count of these patients. So yes, all the patients in the study are those that have failed standard-of-care. They have essentially tried other therapies and have not been eligible to enter into other say, phase 2, phase 3 clinical trials. So yes, these are in-stage patients.

However, what we've done is with respect to going forward with cohort 5 and so on, is to make sure that the baseline lymphocyte count is above 1,000. So that certainly means that the inclusion criteria has been made a little bit more stricter. And therefore, the pool of patients available is fewer, and therefore, adding more time to the process, although not significantly, but a small increase in time for us to get those patients to be in the study.

Now with respect to how these patients would compare to the dose expansion phase of the study. Again, in the dose expansion phase of the study, we would expect patients that have not gone through three, four lines of prior therapy, there would certainly be patients who would be eligible for studies where the recommended phase 2 dose has been established in sort of typically phase 2 settings, particularly in terms of our design of where the patients might benefit the most.

So yes, the patient population in the dose expansion phase will certainly be less advanced. They certainly will have the sort of the baseline lymphocyte count above 1,000. But in this current dose escalation portion, they still are in-stage patients, but at least they have sort of a better baseline lymphocyte count than the patients enrolled in the earlier dose cohorts.

David Martin

Okay, great. Yep. Last question, you mentioned you're getting responses in stable disease in patients with tumors that you wouldn't expect to respond to immunotherapy. What about patients where you would expect them to respond to immunotherapy? How's the drug doing in those patients? And are you gleaning what defines a patient who will respond or is more likely to respond? Or are you seeing, for instance, that if they have over 1,000 lymphocytes baseline that those are the ones that are responding, are there other characteristics?

Fahar Merchant

That's sort of difficult, especially in the Phase 1 portion of the study, where clearly we are trying to accumulate as much data as we possibly can. And if we sort of go back to data from earlier studies of Proleukin, and other competing clinical trials with competing IL-2 programs, we've generally found that the baseline lymphocyte counts in those patients have generally been between 1,000 and 2,000 lymphocytes per microliter. So basically, by us, using a 1,000 microliter is sort of 1,000 counts per microliter, instead of aligning ourselves to what we've seen with Proleukin, for instance.

Now, with respect to patients, it's sort of difficult because each of them as you know, this is a basket portion of the study where we are dose escalating. We've allowed patients with as many as eight different tumor types. And it's difficult to sort of generate any kind of trend lines. But I think the important thing here is that we certainly have seen patient, as you know, with pancreatic cancer. We know that pancreatic cancer does not respond well to immunotherapies. We also know that there has been no report of single agent activity of Proleukin on pancreatic cancer patients. So this is an encouraging sign.

What might be the reason we cannot say for certain, but we just know that MDNA11, because of its selectivity of its high potency, its ability to stimulate both the innate and the adaptive immune systems has that potential additional ability to perhaps have a much better response in patients that have cold tumors.

Now, mind you, when we have patients that have been in the study, as I mentioned, the pancreatic cancer patients, we also see a similar situation with a stable disease, as we mentioned in a patient with renal cell carcinoma. Now normally, you would expect patients with renal cell carcinoma to respond to Proleukin as it has been approved for that patient population. But generally, if you look at renal cell carcinoma, the patients that will respond are the patients with what we call clear cell renal cell carcinoma.

In our case, this is a patient that has stable disease with non-clear cell RCC. And that is a much more challenging situation with Proleukin as well. So again, we're seeing that sort of activity in this kind of patient population, which is again, encouraging. However, as you know, patients in the study have gone through multiple treatments. It's not only the tumor type that matters, I would say, that it also perhaps the fact that these patients had low lymphocyte counts might be an issue.

The other thing is that some of these patients might have gone through more therapies and failed multiple lines and their baseline condition might not be as good, especially if they have gone through additional chemo and radiation therapy with fewer immune cells. So we are certainly getting to this, the intent is, we'll be able to see the effect more clearly as we enter into the sort of RP2 dose range. Okay?.

David Martin

Okay. Thank you.

Operator

Our next question comes from the line of Matthew Biegler with Oppenheimer. Please proceed with your question.

Unidentified Analyst

Hey, great. Good morning, guys. This is Matt Hagan [ph] on for Matt. I was wondering if you could just expand a little bit on the dose escalation strategy, kind of stated, but sort of what criteria you're looking for to know you've reached that optimal dose versus dosing higher? And I guess you think you'll need to dose all the way to DLTs to find the optimal dose? Thanks.

Fahar Merchant

Right. Thanks, Matt. Good question. So, certainly, we'll be monitoring DLTs as you are aware of the set of the protocol is very specific that we would certainly not be able to goes beyond the DLT. So the first and foremost thing in terms of defining or reaching a certain dose is once we see signs of DLTs, then of course, that's when we would stop further escalations and revisit a lower dose. So that might be -- that's one aspect.

Now in the event, we don't see DLTs, as we had those escalating. The other thing that we will be looking at is when we achieve a plateau of immune cell proliferation and activation. So that's the sort of the other set of information that will really monitoring in order for us to determine the RP2 dose. So those are the two parameters that will be sort of optimizing. And based on that, we'll be able to decide on proceeding with the RP2 dose. Hope that answers your question.

Unidentified Analyst

Great. Thanks, guys.

Operator

Our next question comes from the line of Catherine Novack with Jones Search. Please proceed with your question,

Catherine Novack

Hi. Good morning. I just curious you know, since you said you have so far been seeing good safety results. With this timing dose, is there a possibility to change the step up dosing strategy to possibly expedite getting patients up to more efficacious dose?

Fahar Merchant

Good question. And that is something that certainly as part of the dose escalation strategy would be perhaps two things we could, increase the target dose, there's opportunities to expedite the – also the duration or reduce the duration during the priming phases, or the step up dosing, so those options are open. And therefore something that would be visited, if we find that that has potential benefit to the patient.

Catherine Novack

Yeah. And is there an update on the pancreatic cancer patient? Are they still on study? Do you plan to dose escalate them if you know they're still on study at the time when you're when you're reaching higher doses?

Fahar Merchant

Yeah, so the protocol does allow that as long as patients are in the study, and we have cleared sort of the next higher dose, those patients will be eligible for the higher dose. So in that case, patients, the pancreatic cancer patients receive the 60 microgram dose as the target dose. Once the 90 microgram dose clears, that patient wouldn't be eligible for issuing the higher microgram dose. And yes, the patient is continuous on study, as is the melanoma patient and the renal cell carcinoma patient.

Catherine Novack

Got it. And just one more if you can give any color on, you know, patient characteristics that have been enrolled in cohort 5 in terms of, tumor types that previously would have been thought 2 -- RESPOND 2, IL-2?

Fahar Merchant

Well, the thing is that we haven't, as we did proceed with the dose escalation portion of the study, that did not have any sort of constraints in types of tumor types, we had a list of about 12 to 15 different tumor types that are eligible. So the same patient population is eligible even in cohort 4, the only thing that we have implemented going forward is to make sure that the baseline lymphocyte count was above 1,000. Having seen particularly in the call tumor in pancreatic cancer patients, which was certainly unexpected, to see a response encourages us not to at the moment, limit the tumor types, we rather continue with the tumor types, just in case patients with other tumor types that we haven't tested might even show stable disease response, et cetera. So we are not constraining there. But just that the – we have increased the threshold or let's put it this way, we've set a threshold for 1,000 lymphocyte counts per microliter. So that's the only big change we've made.

Catherine Novack

Got it. That's, that's very helpful. Thank you so much.

Fahar Merchant

Thank you, Catherine.

Operator

And our next question comes from the line of [indiscernible] with Zach. Please proceed with your question.

Unidentified Analyst

Hey, good morning Fahar and good morning Liz. So, Fahar, I'm curious what the status is on any type of paired biopsy samples that you have for the patients and is that something that you can try to maybe emphasize more We're going forward here in the trial?

Fahar Merchant

Well, we haven't received too many of them yet, I think we have, if I'm not mistaken, about just two or three pairs biopsies so far, we hope to get some additional as we enroll patients and get patients in cohort 5 to do the same. More likely that we'll get more of the paired biopsy patients in the dose expansion phase, but we plan to analyze whatever data we get from the pet biopsies to date. Hopefully, we'll have that done after the dose escalation is completed. And certainly, continue that same process. Hopefully, we'll learn a bit more from the paired biopsies before we get started with the dose expansion.

Unidentified Analyst

Okay. And regarding the recent financing, so it sounds like the ability trial is fully funded. I'm just curious once that takes into account, a potential six or higher dosing cohort? And then also, how much will that fund at the biscuit program your current cash on hand?

Fahar Merchant

Yeah, so we do have room to, add additional cohorts if necessary, in the dose escalation portion. As you might have noticed, we've also increased the number of patients in the dose expansion to 40, each in the monotherapy, and the combination part of the study. So that's sort of being covered as well. And with respect to the biscuit program, this financing has been is adequate for us not to commence a phase a clinical trial with the biscuit program, but sufficient enough to advance it further to the stage where we are able to commence some IND enabling studies. Liz, perhaps you might be able to provide a bit more clarity there, Liz?

Liz Williams

Yeah. Sure. Thanks for Fahar. Yeah, so our current focus is obviously on the MDNA11 ABILITY study. So our current runway projections cover 100% of the costs for both the monotherapy and combination arm, as well as the work on the BiSKIT platform to get a molecule to IND readiness. And that takes us into Q2 2024. And we have the ability to kind of allocate proceeds between the programs as needed to ensure that the runway stays in tact or like this.

Unidentified Analyst

All right. Sounds good. Appreciate you taking the questions.

Operator

Thank you very much. And our next question comes from the line of David Martin with Bloomberg. Please proceed with your question.

David Martin

Thanks for taking my follow up. I wanted to go back to this selecting patients with baseline lymphocytes of 1,000 per microliter or above. You mentioned with Proleukin, you'd see that trend, if they were above they were more likely to respond to below less likely. What about in your dose escalation so far? Are you seeing the patients that the patient that responded and the patients with stable disease as being the ones who have this 1,000 or higher baseline?

Fahar Merchant

Yeah, so patients, the thing is that with Proleukin, what we see is published literature, they haven't actually shown us that the baseline lymphocyte, or they haven't provided data on patients with baseline lymphocyte counts less than 1000. Generally, we'll see that those data show that the baseline lymphocyte counts is anywhere between 1,000 to 2,000, more close to 2,000 than 1,000. It's around 1,500 or so in the post Proleukin studies that have been published.

And there has been no sort of correlation per se. However, when we look at the sort of the peak lymphocyte count, we've seen data from certain studies where Proleukin has shown that when the peak lymphocyte count increases above 3,000, there is a higher probability of patients responding or having stable disease versus those patients that do not get to the 3,000 threshold.

Now, when we look back at our first three or four cohorts of the patients that we've treated, especially the first three cohorts, we find that the baseline lymphocyte counts worse sub 1000 on average, and we rarely saw the lymphocyte counts go above 3,000 in those situations, because of the baseline being so low, in some cases, it was as low as just 300 counts per microliter.

So, as we've gotten into cohort 4 and, enrolling patients in cohort 5, at least in cohort 4, our baseline lymphocyte counts, as you will see and what we've presented at the previous in our corporate deck, you will see that the baseline lymphocyte count, on average is above 1000. And that's why we are seeing again, on that corporate deck, the lymphocyte counts being above 3000. And it's too early to say, it's been very few patients with that kind of baseline lymphocyte counts. So, we're hoping that as we proceed into cohort 5 and 6 that especially in those expansion, where we have less sick patients, that will sort of translate into better responses at exceeding the 3000 threshold that Proleukin was able to achieve.

David Martin

So setting that as the bar for inclusion in the trial, does that de facto define the patient is less heavily pretreated?

Fahar Merchant

Well, let's put it this way. It does define patients who are likely have a better immune system or they have received less -- let's put it this way less chemotherapy or radiation therapy that might have substantially impacted their lymphocyte counts. Or patients might have received chemo or radiation therapy, but not recently. Those patients that would have just recently gone through chemo or radiation, et cetera, would more likely have lymphocyte counts that are quite low.

David Martin

Okay, got it. That’s it for me. Thanks.

Fahar Merchant

Okay. Thanks.

Operator

And we have reached the end of the question-and-answer session. I'll now turn the call back over to Dr. Fahar Merchant for closing remarks.

Fahar Merchant

Thank you very much. I'd like to thank you all for joining the call today. And it's been a pleasure for us to update all of you listening, any participation. Our recent progress has certainly strengthened the outlook of our pipeline, particularly our MDNA11 program. We look to we look forward to providing a periodic updates as our programs continue to progress. Thank you all and have a great day.

Operator

And this concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.