Medicenna Therapeutics Corp. (MDNA) Q3 2023 Earnings Call Transcript

Medicenna Therapeutics Corp. (NASDAQ:MDNA) Q3 2023 Earnings Conference Call February 7, 2023 8:30 AM ET

Company Participants

Dan Ferry – Investor Relations, LifeSci Advisors

Fahar Merchant – President and Chief Executive Officer

Liz Williams – Chief Financial Officer

Conference Call Participants

Charles Zhu – Guggenheim

Matt Biegler – Oppenheimer

David Martin – Bloom Burton

RK – H.C. Wainwright

Catherine Novack – Jones Research

David Bautz – Zacks Small-Cap Research

Operator

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

I would now like to turn the call over to Dan Ferry of LifeSci Advisors. Thank you. 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 December 31, 2022. If you have not seen the press release, it is available on the Investor 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, development and tolerability and safety profiles, MDNA11, preliminary clinical data, the clinical potential and development of MDNA55, partnering efforts, cash runway, the presentation of additional data and other milestones and patent protection are forward-looking statements that are subject to risks and uncertainties.

There can be no assurance that such statements were proved to be accurate, and actual results and future events could differ materially from those anticipated in such events. Important factors that may cause the actual results to differ materially from the company’s expectations, include the risks detailed in the Annual Information Form and 20-F of the company and in other filings made by the company with 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, the company does 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 the 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. I’ll begin by discussing the most recent news out of our Phase 1/2 ABILITY study of MDNA11, our beta-only long-acting IL-2 super-agonist. Earlier this morning, we announced that the Phase 1 portion of the ABILITY trial advanced to a sixth dose escalation cohort, where patients will receive a target dose of 120 micrograms per kilogram every two weeks. This is encouraging, as it reflects that MDNA11 has a suitable tolerability profile in the end-stage cancer patients that have enrolled in the Phase 1 study to-date.

The decision to advance to the sixth cohort was based on a review of the cohort five safety and preliminary pharmacodynamic data by our Safety Review Committee, which consists of study investigators, key opinion leaders and external devices. With regards to safety, we are pleased to say that MDNA11 has been well tolerated, with no dose-limiting toxicities, dose interruptions, dose de-escalations, or treatment discontinuations due to safety issues.

With regards to pharmacodynamics, we observed further increase in lymphocyte expansion in cohort five when compared to cohort four, which indicates that MDNA11’s ability to stimulate an anticancer immune response had not yet plateaued. Collectively, these data suggests that we may be able to safely administer higher doses of MDNA11, which in turn could further enhance anticancer effects.

To begin testing this hypothesis, cohort six’s dosing regimen includes 30, 60 and 90 micrograms per kilogram priming doses of MDNA11 followed by a further step up to the fixed 120 microgram per kilogram target dose I had mentioned earlier. For comparison, participants in the fifth cohort received two 30 microgram per kilogram priming doses before stepping up to a fixed 90 microgram per kilogram dose. All doses are administered intravenously every other week.

In addition to evaluating a higher fixed dose of MDNA11, the dosing regimen in cohort six has the advantage of getting participants to the 60 microgram per kilogram dose after only two weeks, as opposed to after four weeks, this was the case of cohorts five and four. This is important, as the 60 microgram [technical difficulty] dose of MDNA11 has already led to tumor response as presented last quarter at the SITC Annual Meeting.

The data presented at SITC showed tumor control in 5 of 14, or 36% of evaluable patients treated with MDNA11 monotherapy. This included a confirmed partial response in a fourth-line metastatic pancreatic cancer patient treated at 60 micrograms per kilogram, demonstrating MDNA11’s single-agent potential in a notoriously difficult-to-treat cancer.

We also observed encouraging signs of MDNA11’s potential to drive durable clinical benefit as the patient achieving the partial response for further deepening of tumor response on each of the two consecutive scans, while another patient with metastatic melanoma has maintained stable disease for more than a year and remains on study. These promising antitumor activity data were notably achieved in an extremely challenging patient population, with nearly 80% of patients having failed prior immunotherapy, including the pancreatic cancer patient achieving a partial response.

The data are supported by PD results that showed dose-dependent and multi-fold increases in anticancer immune cells with MDNA11 treatment, but not stimulation of Tregs or eosinophils. This is important, as Tregs are associated with pro-tumor immune pathways, while eosinophils are associated with vascular leak syndrome, a serious life-threatening side effect of the only approved IL-2 therapy, Proleukin.

Presented alongside these PD data, were results demonstrating MDNA11’s tolerability at [technical difficulty] doses as well as PK data that showed dose-dependent increases in exposure that remain consistent with repeat dosing, suggesting a lack of an anti-drug-antibody response. Those interested in reviewing any of these data in detail, can find both SITC presentations on the Events section of our IR website. Collectively, we believe ABILITY’s early results demonstrate how MDNA11’s carefully engineered design positions the Superkine as a potentially best-in-class, long-acting beta only IL-2 therapy.

We believe the key design features of MDNA11 can provide cancer patients with clinical benefit by avoiding the PK and safety shortcomings that’s like Proleukin. ABILITY’s data to-date supports this hypothesis, which we plan to continue exploring with several important readouts from ABILITY expected over the coming months.

The first of these readouts is anticipated later this quarter, and will include initial antitumor activity data and high level PD findings from ABILITY’s fifth dose escalation cohort, alongside updated data from cohorts one through four.

As in earlier cohorts, cohort five enrolled difficult-to-treat patients unresponsive to prior treatments. The same will be true for cohort six, as each dose escalation cohort utilizes similar inclusion criteria. We do however, plan to take a different approach to enrollment for the Phase 2 expansion portion of the trial, where the objective will be to not only demonstrate safety in approximately 40 patients, but importantly, evaluate the efficacy of MDNA11 in patients with less advanced cancer and tumor types that are most likely to benefit from our IL-2 Superkine.

Therefore, rather than enrolling patients with a dozen or more disparate tumor types, which has been the case with the Phase 1 portion of the ABILITY study, the Phase 2 portion will only focus on two or three different cancer populations that better reflect MDNA11’s target addressable population. As we look towards the identification of MDNA11’s optimal regimen and ABILITY’s Phase 2 expansion phase, we are optimistic on the trial’s outlook.

Having shown an ability to achieve enduring tumor control in a challenging patient population, we expect that MDNA11’s demonstrable durability of response, which is a major challenge with approved immunotherapies could be further enhanced with optimal dosing regimen, and in a population of patients with better initial prognosis.

Our current projections have us reporting data from ABILITY’s six and potentially the final dose escalation cohort, together with early antitumor activity data on the Phase 2 dose expansion cohort in the third quarter of this calendar year. In addition, we anticipate reporting early data from the trial’s combination arm evaluating MDNA11 plus Keytruda in the fourth quarter of this calendar year, providing us with multiple near-term opportunities to derisk MDNA11 and demonstrate its potential as a vital component of cancer immunotherapy.

Shifting gears, I would like to provide a brief update on MDNA55. The top line results from the single-arm Phase 2b clinical trial of MDNA55 in patients with recurrent unresectable glioblastoma, a uniformly fatal form of brain cancer, have been published in the peer reviewed journal, Neuro-Oncology, which is the official publication of the Society for Neuro-Oncology.

These results showed that the trial met its primary endpoint, with median overall survival in the primary and supportive analysis populations exceeding pre-defined success criteria and key historical benchmarks. These promising results helped us to align with the FDA on an innovative, open-label hybrid design for a potential pivotal trial. I’m also happy to mention that the World Health Organization has approved the international nonproprietary name for MDNA55, which will now be referred to as Bizaxofusp.

Looking forward, we continue to pursue Bizaxofusp’s further development and potential commercialization to external partnership, as we have stated consistently in the past. This will allow us to enable Bizaxo’s advancement, while maintaining our internal focus and resources on MDNA11 in our BiSKITs program, which was the subject of a key patent issued earlier this year.

This new issued patent extends protection into at least [technical difficulty] with an IL-2 Superkine in combination with checkpoint inhibitors, such as an anti-PD1 inhibitor, which is being advanced in the combination arm of the ABILITY study. And for BiSKITs, such as MDNA223, which comprises an IL-2 Superkine linked to an anti-PD1 antibody. With checkpoint inhibitor patents, due to start expiring in 2028, we believe the data from ABILITY’s combination study as well as MDNA223’s IP could be an important tool to facilitate collaborations or partnerships with leaders in the space.

And with that, I’d have Liz review our fiscal third quarter financial results. Liz?

Liz Williams

Thanks, Fahar. I’ll begin today by reminding those listening, that all references made during this section of the call are in Canadian dollars, unless otherwise stated.

As of December 31st 2022, Medicenna had cash and cash equivalents of CAD36.2 million. Based on our projections, our current cash resources are sufficient to fund our operations through the second quarter of calendar year 2024. This cash runway is expected to take us through several important clinical readouts and the completion of the ABILITY study, including both the monotherapy and combination expansion phases designed to assess MDNA11’s efficacy in relevant patient populations.

Net loss for the quarter ended December 31st, 2022 was CAD1.1 million or CAD0.02 per share, compared to a loss of CAD4.8 million or CAD0.09 per share for the quarter ended December 31st, 2021. The significant decrease in net loss for the quarter ended December 31st, 2022 compared with the quarter ended December 31st, 2021, was primarily a result of a non-cash gain of CAD3.7 million related to the change in valuation of a non-cash warrant liability associated with the August 2022 financing.

Research and development expenses of CAD2.9 million were incurred during the quarter ended December 31st, 2022, compared with CAD2.9 million incurred in the quarter ended December 31st, 2021. Research and development expenses were consistent quarter-over-quarter.

General and administrative expenses also remain consistent quarter-over-quarter, with CAD2 million incurred during the quarter ended December 31st, 2022 as well as during the quarter ended December 31st, 2021. For further details on our financials, please refer to our Financial Statements and Management’s Discussion and Analysis, which will be available on SEDAR and EDGAR, respectively.

With that, I’ll hand the call back to Fahar for closing remarks.

Fahar Merchant

Thanks, Liz. Before opening up the call for Q&A, I’d like to first thank all those who have supported the progress we spoke about today, including our employees, partners, investigators, shareholders, and clinical trial participants. I’d like to also emphasize how our recent progress has us set up for an exciting calendar year ahead with crucial milestones anticipated throughout 2023.

The first of these milestones is expected later this quarter, which is when we anticipate reporting high level PD findings from ABILITY’s first five dose escalation cohorts and an update on antitumor activity. In cohorts one through four, MDNA11 displayed promising signs of monotherapy activity, as well as safety, PK and PD profiles that position it as a potentially best-in-class IL-2 therapy. The key objectives of cohorts five and six are to confirm if MDNA11’s immunologic activity can be enhanced with higher doses, and whether these higher doses will be adequately tolerated.

Based on what we’ll see in additional readouts from ABILITY’s dose-escalation phase, we will select the optimal dose and schedule for the trials Phase 2 monotherapy expansion and combination arms. The Phase 2 component of the study will be specifically designed to assess MDNA11’s efficacy in patients that are similar to its target populations.

We therefore believe that the readouts anticipated from the Phase 2 portion of the trial which are expected in the third and fourth quarter of calendar 2023 may represent significant derisking events for the MDNA11 program. With encouraging signals of efficacy already observed in the extremely difficult-to-treat patients during the trial’s dose escalation. We are optimistic about the ABILITY’s studies outlook. We look forward to its continued progress and to providing periodic updates along the way.

And with that, we will now begin our Q&A session. Operator?

Question-and-Answer Session

Operator

Thank you. The floor is now open for questions. [Operator Instructions] The first question today is coming from Charles Zhu of Guggenheim. Please go ahead.

Charles Zhu

Good morning, everyone. Thanks for hosting the call and for taking the questions. First one from me, if I recall dose cohort five, was also the first when you instituted the new requirements around baseline lymphocytes. To what degree might the enhanced lymphocyte stimulation or PD markers you’re observing be influenced by this higher baseline? And how do you think about that relative, you know due to the higher doses of MDNA11 you’re evaluating? Thanks.

Fahar Merchant

Thank you, Charles. That’s a good question. Certainly, as you know, we set a threshold for lymphocyte counts in this particular study. And we clearly are seeing that and we’ve seen mostly from previous studies with Proleukin, where a high baseline lymphocyte count generally results in better patient outcomes. The key thing here is, although that’s something that’s been demonstrated historically, we certainly do not have as much data with our therapy and our therapeutic regimen that we use with MDNA11.

Needless to say, we have, I think, if you recall, between the first three cohorts where the doses were below 60 micrograms per kilogram, we still saw patients with stable disease, including a patient that continues to be treated in cohort two, who started at 10 micrograms per kilogram where the lymphocyte count or the baseline lymphocyte count was not necessarily set at 1,000 per microliter.

So it may be a sort of a threshold that’s maybe more relevant for Proleukin or other IL-2 based agents. But certainly, as far as we are concerned, although we feel that you can get to the threshold lymphocyte count or a higher lymphocyte count or expansion to occur, we certainly haven’t seen any consistency in the data that we have so far.

Nevertheless, we expect that as we entered into sort of the Phase 2 portion of the study where we have patients with higher or sort of less heavily pre-treated healthier patients more likely that we have patients with higher lymphocyte count. So it’s a bit premature right now to come to any conclusions based on the data we have, only 14 patients so far. But we are encouraged to see that even a patient who started at less than 1,000 lymphocytes per microliter continues to be on study for now 15 months. So that’s quite encouraging.

Charles Zhu

Got it, great. Thanks for taking the question.

Operator

Thank you. The next question is coming from Matt Biegler of Oppenheimer. Please go ahead.

Matt Biegler

Hey, guys. Thanks for the update. I’m curious Fahar based on the preclinical data. Do we expect to plateau out on lymphocyte count in cohort six or I guess another way to ask the question is, how do we know when we’re at the recommended Phase 2 dose? And I have a follow-up.

Fahar Merchant

Right. Thanks, Matthew that’s a good question again. And I must say that you’re right on spot when you talk about the data from preclinical studies. So, certainly what we have. The way we have projected dosing regimens and selecting the different doses and different cohorts is given mostly by extrapolating from data we have from non-human primate studies.

And based on the safety windows that we saw in non-human primates, as well as where we saw the threshold occurring in non-human primates, I would say that the current dosing regimen that we are enrolling patients in which is the cohort six at 120 micrograms per kilogram is pretty much close to where we’re expecting this to plateau.

As you know, we saw pretty impressive results at studying at cohort four and for 60 micrograms per kilogram dose so far we’ve had, as you know, the data we have shared of just seven patients that have received more than 60 or 60 micrograms per kilogram or higher. And based on the data we have so far, it seems like we are seeing pretty impressive clinical activity.

Add to that, the fact that we are continuing to see increases in lymphocyte count at 90 micrograms per kilogram as we reported today, we believe that when we get to 120 micrograms per kilogram, we should be pretty much on par with the upper limits of dosing where we had from non-human primates.

So, so far, the trends from non-human primate data are predictive of what we’re seeing with the lymphocyte counts with other expansion of CD8+ T cells, NK cells. So being consistent, and we believe that we are pretty much close to that upper limit. And we do not expect that we will necessarily have to go to sort of next higher dose.

But we already have a promising data from the 60 micrograms, we have data from 90 and 120. So we have three sets of data or dosing to pick from, in view of the fact that we’ve met the safety burden with both the 60 and 90 micrograms, and see if we meet the same safety burden at the 120.

But generally, across the board, we feel pretty comfortable that above 60 onwards, we should be having a therapeutic activity that’s more than adequate for MDNA11, obviously, we want to make sure that before we enter the Phase 2 portion of the trial, we need to make sure that we can confirm that by testing the higher doses as well.

Matt Biegler

Right, right. That makes sense. Okay. And then maybe just a quick follow-up on, I’m sure you’re aware of Proleukin was effectively sold to Iovance few weeks ago. I’m just kind of curious on your view of that transaction, and kind of what that means for the field. And if, you know, in the future there’s any opportunities to combine with other therapeutic modalities outside of checkpoint inhibitors? Thanks.

Fahar Merchant

Right. Again, really good question, Matt. That really was an indication as to how large the potential opportunity is for molecules such as MDNA11. I think if you recall the data from Iovance that presented at SITC, clearly indicated that in the Phase 3 setting, where they were using Proleukin, the toxicities were clearly there, they were obviously not desirable. And it’s not surprising that Iovance is also looking to develop a much safer version of IL-2.

So, I believe about that the potential for IL-2, particularly MDNA11, where we have the selectivity for boosting NK cells and CD8+ T cells and not Tregs, becomes really important, because after going through a sort of a long process of isolating your T cells from the patient, and then having to expand them through ex-vivo manufacturing, and then re-infusing the T cells. That itself, I think, as you know, is a long process and you want to make sure that you have the best quality of T cells that you’re infusing into the patient.

The good thing about a molecule such as and doing a good job of stimulating your immunosuppressive Tregs, and this is exactly what we want, this is from a manufacturing perspective, make sure that you’re able to boost the population of CD8 + T cells and NK cells, not Tregs, which unfortunately is not the case with Proleukin, because it will boost the population of Tregs. And then when you insert or re-infuse the T cells, you want to continue to expand those T cells selectively, not expand your Tregs. And this is again where MDNA11 has its distinct selectivity and therefore distinct advantage.

So we believe that this particular Iovance transaction sets the stage clearly for all other T cell-based processes or car-T-based processes, et cetera, where not only what a drug such as MDNA11 be ideal for manufacturing purposes, but more importantly, is to then stimulate those T cells in the patient without boosting your Treg population. So that’s, I think, an important industry or important opportunity to exploit and I think MDNA11 is really well suited for the purpose.

Matt Biegler

Very cool. Thank you guys for the question.

Operator

Thank you. The next question is coming from David Martin of Bloom Burton. Please go ahead.

David Martin

Good morning. I got a couple of questions. The first one is just a clarification. When you were speaking, Fahar, I think you said that we get PK/PD and initial efficacy results for cohort five in the first calendar quarter. In the press release, it kind of indicates only PK/PD and the efficacy will be an update for cohorts one through four. Just confirming, are we getting efficacy data for cohort five in Q1?

Fahar Merchant

I did not realize. Thanks, David for that particular question. But yes, let me sort of correct that. If the press release did not mention that, then apologies. But yes, the intent is for us to release the PK/PD, but also the tumor activity data from cohort five before the end of this quarter.

David Martin

Okay. Another clarification. So, with the patients with higher baseline lymphocyte counts in cohort five and six, you had anticipated that by using that inclusion criteria that you would get healthier patients. And yet, you’re saying that cohort five, cohort six are still very sick patients, and you’ll only start getting healthier patients in the dose expansion. So is that correct by selecting based on the higher baseline lymphocytes, you didn’t get healthier patients in five and six?

Fahar Merchant

Well, it’s not as you know, healthier patients is based on the healthier immune system, certainly, in cohorts five and six, you end up with patients with sort of a baseline lymphocyte count that is higher than what we enrolled in cohorts one, two and three.

So, from that perspective, certainly, what we want to try and simulate is, obtain or realize that in cohorts – in the expansion cohorts, we will be looking at patients that have gone through fewer lines of therapy. And therefore, we expect that those patients enroll in that expansion cohort will likely have higher lymphocyte counts.

So it’s in a sense for us to provide that information to gather that informations, we are better able to foresee what to expect going down the road. But remember one thing about patients that have gone through multiple lines of therapy, it’s their lymphocyte count primarily from their immune health perspective.

But then again, there are a host of other issues that we need to take care of or worry about, because remember, in the dose-escalation portion of [technical difficulty] where we are is really treating about a dozen different types of tumors in this particular portion of the trial.

So trying to sort of come up with some kind of homogeneity or minimizing the variability [technical difficulty] here with sort of trying to stabilize and using 1,000 lymphocyte counts per se. But nevertheless, patients would have, as you know, gone through so many different type of therapies, some focused on immunotherapies others with different kinds of chemotherapies as well.

So we have a very diverse patient population in the dose-escalation phase, where not only are we dealing with different tumor types, but also different therapies that patients have received. And patient’s health is not only determined by the immune count, but also from other prognostic factors, age is a good example for instance.

So that also, we cannot obviously restrict from that perspective. But there is a host of variations that we take into account. But the focus really now is planning for the dose expansion phase of the study, and identifying two or three different tumor types that are most likely to be beneficial to the patients, these patients certainly will not be onstage patients.

And therefore, we expect the patients to be more homogeneous than we were in the Phase 1 dose-escalation part, where even if you have lymphocyte counts standardized, we still are dealing with 12 to 15 different tumor types. So it’s a set of a combination of different, far too many parameters in the dose-escalation portion that we cannot really predict what would happen. But nevertheless –

David Martin

Okay.

Fahar Merchant

Very encouraging to see that in cohort six, we were able to show promising data above the 1,000 lymphocyte count.

David Martin

Okay. Just one last quick question. With a new priming schedule, you say you get to the 60 dose faster. Can you remind me when your dose cohort that dosed at 60? Did you go right to 60 or did you start at 30 and went to 60?

Fahar Merchant

No, we started at 30 and there were two doses of 30 in the cohort four, and then went to 60. So, it took four weeks before we got to 60. In this case, we’ll get to 60 in two weeks.

David Martin

And you’re pretty comfortable that they’ll be able to tolerate getting to 60 that fast?

Fahar Merchant

Well, that’s the objective and that’s why we had a Safety Review Committee to make that final call.

David Martin

Okay. Okay, that’s it for me. Thanks.

Operator

Thank you. The next question is coming from RK of H.C. Wainwright. Please go ahead.

RK

Thank you. Good morning, Fahar. And a lot of my questions have been answered. When you get to Phase 2, I was just wondering, you know, among the four indications that seem to be the ones that you’re looking at during the stage of development, you know, how would you order them? Or would you consider just taking the pancreatic and the melanoma as indications to go forward?

Fahar Merchant

Yeah, we haven’t decided specifically on the tumor types so far. And I think we continue to review the data. We certainly will be collecting more data from cohort five, cohort six as well as historical data that we’ve seen so far from the first four cohorts.

So we are working closely as to what indications to pursue it in the dose expansion, and we will provide an update as soon as we have had received feedback and guidance from our clinical advisors, KOLs, et cetera based on the growing body of evidence from the current study that we are conducting. So nothing’s been etched in stone at this moment.

RK

Okay. And then one last question for me. Any update on the BiSKIT program? Because we didn’t hear much today.

Fahar Merchant

Yes, so the BiSKIT program, since our last set of data we presented at our conference late last year, we continue to advance that particular program, we certainly are continuing to optimize the design of the molecule and generating more in vitro, in vivo studies and characterizing that molecule further. So we will, as we get an opportunity to present data at additional conferences, or submit a publication, we will be providing more evidence and more data at that time.

RK

Okay, thank you. Thank you for taking the questions.

Fahar Merchant

You’re welcome. Thank you.

Operator

Thank you. The next question is coming from Catherine Novack of Jones Research. Please go ahead.

Catherine Novack

Hi, good morning. Thanks for taking my question. Just a couple from me. One, you know, in terms of the Phase 2 cohort data or Phase 2 data in the third quarter of ‘23. I’m curious, does that mean that you know you’ve settled on a Phase 2 dose given that I imagine that you all have to start enrolling that before the 120 micrograms per kilogram dose cohort has finished reading out, you know, or do you anticipate you know further dose finding work in the expansion phase?

Fahar Merchant

No, we will not be doing any further dose finding studies during expansion phase. So, we will establish what we call is a provisional recommended Phase 2 dose that will be executed and implemented in the dose expansion phase of the study. So that’s the plan. And we expect that we’ll have some early data by the end of third quarter this year.

Catherine Novack

Okay. And then can you give any additional color maybe on the kind of efficacy data we’ll see from cohort five, you know, how many patients? What kind of follow-up? And then have you gotten any additional paired biopsies in this quarter or in this cohort?

Fahar Merchant

Yeah, so we will be providing more data. As we plan to do that at the end of this quarter. This will allow us to share with you all the patients that have been enrolled in cohort five, the type of tumors they had, the number of lines of therapy they had, as well as their PK/PD, and, of course, tumor response data. So we will be presenting all that together as a complete set of data, including data from patients in earlier cohorts that are still under study.

Catherine Novack

Okay. And then, in terms of patients that are still on the study, I believe that the last update there were three still on study. Any update on that?

Fahar Merchant

Yeah. So that will be when we present that update at the end of this quarter on those three patients plus the patients in cohort five. So we will be able to share all that information, including the data from more recent scans from not only the cohort five, but also from the earlier cohorts as well.

Catherine Novack

All right. Thanks so much for taking my questions.

Fahar Merchant

You’re welcome.

Operator

Thank you. The next question is coming from David Bautz of Zacks Small-Cap Research. Please go ahead.

David Bautz

Hey, good morning, everyone. Yeah, Fahar, I’m curious why you aren’t restricting the patients for cohort six to certain tumor types. I understand you haven’t decided exactly what you’re going to look at in the Phase 2 expansion cohort. But I’m curious why you aren’t limiting it to even the ones that you’re considering for Phase 2?

Fahar Merchant

Well, I think the key thing here is, of course, the range of tumor types we’ve already treated is, as I said, about a dozen or so, trying to generate data on three different tumor types in a cohort of maybe three or six patients is unlikely to provide you with certainly any trending data. But obviously, what we’re trying to do is, try and enroll more patients that would potentially fit the profile for the dose expansion.

But we’re not sort of change the protocol right now, either have we instructed the sites to only limit it to one or two or three different tumor types. It’s too early. I would say that the purpose of dose expansion is to do that exact same as – the idea in the dose expansion is to really have adequate number of patients in those two or three different types of tumors, rather than having to make a decision based on three or six patients.

David Bautz

Okay, that makes sense. And then real quick, when you present this updated data later on this quarter, will that be at a scientific conference? Or is that going to be through just a press release?

Fahar Merchant

Well we – as you said, the data from cohort five will be presented at the end of this quarter with additional data that comes through, it’s likely that we’ll present at a scientific conference. So we will at that point, depending on when the scientific conference takes place, we should have more data on cohort six potentially even early data on the dose expansion, but that remains to be seen.

David Bautz

Okay, sounds good. Thanks for taking the questions.

Fahar Merchant

You’re welcome.

Operator

Thank you. At this time, I’d like to turn the floor back over to Dr. Fahar Merchant for closing comments.

Fahar Merchant

Thank you, thank you very much all of you for joining the call today. Really appreciate the support the patients that have participated in the clinical trials, as well as the families and the investigators that have been patient with the clinical study itself. And, of course, all our shareholders, employees, et cetera, that have been supporting Medicenna’s progress.

We look forward to providing with all of you some additional updates, as we say it, at the end of this quarter, as well as at the end of Q3. And in between, hopefully at a time when there is a conference before the end of third quarter, we will provide additional updates. So look forward to providing those additional data in the coming weeks and months. And thank you all for joining today’s call.

Operator

Ladies and gentlemen, thank you for your participation. This concludes today’s event. You may disconnect your lines at this time or log off the webcast and enjoy the rest of your day.