Ladies and gentlemen, welcome to the annual meeting of shareholders of Medicenna Therapeutics Corp. Please note the meeting is being recorded. I would like to introduce Dr. Fahar Merchant, Chairman of the Board of Directors. Dr. Merchant, please go ahead.
Thank you. The annual meeting of shareholders of Medicenna Therapeutics Corp. will now come to order. My name is Dr. Fahar Merchant, and I am Chairman of the Board of Directors of the Corporation. I will preside as chairman of the meeting, and I hereby appoint Mr. Charles-Antoine Soulière of McCarthy Tétrault LLP to act as Secretary of the meeting. To mitigate risks to the health and safety of our communities, shareholders, employees, and other stakeholders resulting from the unprecedented public health impact of COVID-19, we have opted for a virtual-only annual general meeting. In making the decision to hold a virtual meeting, it was paramount to ensure that shareholder rights were protected. To this end, we have ensured that this meeting offers registered shareholders and duly appointed and registered proxy holders the same opportunities to participate as in past in-person meetings.
Instructions on how to ask questions and how to vote using the virtual platform are located at the top of your screens. The buttons themselves are located on the left side of your screen. Only those who have signed in as registered shareholder or duly appointed proxy holder are entitled to vote or ask questions at this meeting. We'll conduct the votes on all resolutions before the meeting by ballot. On a ballot, every registered shareholder or duly appointed and registered proxy holder entitled to vote has one vote in respect of each common share entitled to be voted on the matter and held or represented by that registered shareholder or duly appointed proxy holder. Since voting on each resolution is by ballot, I will be voting all undirected proxies that I am permitted to vote in favor of all resolutions before the meeting.
Voting is now open, and all registered shareholders and duly appointed and registered proxy holders should have the functionality and ability to cast votes at any time during the meeting until we declare voting closed. Thank you to those of you who have already voted. If you have already voted in advance of the meeting and do not wish to change your vote, then you do not need to do anything further at the meeting. For those who have not yet voted, we encourage you to vote now. If you choose to vote during this meeting, it only can be done through the virtual voting platform on the webcast. To vote, select the voting button located on the left side of the screen and tap the desired voting option.
Your vote will be automatically submitted to TSX Trust Company, our scrutineers, after you click your choice, and will be evidenced by a Vote Received message. Votes may be changed at any time, up to the time voting is closed. Once voting is declared closed, your votes will automatically be submitted. If you do not press either For, Against, or Withhold, as applicable, when voting is open, your vote will not be recorded, and your vote will not be received. Also, registered shareholders and duly appointed proxy holders can submit questions at any time during the meeting through the virtual platform of our webcast. We'll address questions at a general Q&A session at the end of the formal part of the meeting, provided that only questions regarding the procedural matters or questions directly related to the resolutions before the meeting may be addressed during the meeting.
We will receive the questions, and at the appropriate time, we'll read them and the names of the submitting shareholders or proxy holders aloud so that everyone may be aware of the question being considered. In the interest of efficiency, we have a number of questions that are similar in topic. We will paraphrase, group the questions, and mention that we have received similar questions. However, please note that due to the time constraints, we may be unable to address all questions. This meeting has also been made accessible too, and we also wish to welcome all guests who are not registered shareholders or holding proxies of registered shareholders. As a reminder, as with any in-person meeting, only registered shareholders and duly appointed and registered proxy holders are permitted to vote or ask questions at this meeting. In order to make the best use of our time,
Ms. Williams will move, and I will second all motions. While this procedure will facilitate the handling of the formal matters, registered shareholders or duly appointed proxy holders may address the meeting when there is a call to discuss a motion before the meeting. Should you like to address the chairman or any motion, please type in your question or comment in the Ask A Question box available on the left side of your screen. A reminder that this function is only available to those who have logged in as a registered shareholder or duly appointed proxy holder. If there's any discussion or question, the secretary will read the question aloud. All motions will be moved and seconded once the formal matters of the meeting have been presented.
With the consent of the meeting, TSX Trust Company, the corporation's transfer agent and registrar, through its representatives, will act as scrutineers of this meeting. The scrutineers will report on the shareholders present on the virtual platform and the number of securities represented in person and by proxy at this meeting, compute the votes cast by ballot, and report to me on these matters. The scrutineers have reported to me that we have at least two shareholders present by electronic means and holding or representing by proxy at least 25% of the votes entitled to be cast at the meeting. As such, I declare that the requisite quorum of shareholders is present and that the meeting is properly constituted for the transaction of business. I direct that the scrutineers' report on attendance be annexed to the minutes of the meeting.
The notice calling this meeting and the accompanying materials have been mailed to all shareholders of the corporation, and the secretary of the meeting has provided me with proof of service of such materials. Copies of such materials are available on Medicenna's website. Accordingly, the reading of the notice of meeting will be dispensed with. I propose that we proceed with the business of the meeting. The 2022 annual report of the corporation for the fiscal year ended March 31, 2022, together with the 2022 audited financial statements and the related auditor's report, have been mailed to the shareholders of the corporation who previously requested them. Copies of such materials are available on Medicenna's website. It is not intended or required to ask shareholders to approve the financial statements.
However, management will be pleased to deal with any relevant questions concerning the statements during the general question period which follows the formal portion of this meeting. Election of directors. We will now proceed with the election of directors. The proposed nominees to the board of directors are Albert Beraldo, Karen Dawes, Dr. John (Jack) Geltosky, Rosemina Merchant, Dr. Chandrakant Panchal, Dr. John H. Sampson, and myself, Dr. Fahar Merchant. I understand that these nominees have consented to act as directors. Mr. Secretary, are there additional nominations?
Mr. Chairman, I confirm there are no other nominations.
If there are no further nominations, I declare the nominations closed. Appointment of auditor. The next item of business is to appoint PricewaterhouseCoopers LLP as the auditor to hold office until the close of the next annual general meeting of shareholders or until its successor is appointed, and that the directors of the corporations be authorized to fix its remuneration in such amounts as the directors may, in their discretion, determine. Voting on items of business. Now that all formal matters of the business have been presented, would Ms. Williams please make the motions for the formal matters of the meeting. Liz.
Mr. Chairman, first I move that the persons that have been nominated be individually elected as a director of Medicenna Therapeutics Corp. for the ensuing year or until their successors are elected or appointed. Second, I move that PricewaterhouseCoopers LLP be appointed as auditors for Medicenna Therapeutics Corp. for the fiscal year ending March 31, 2023, and that the directors of the corporation be authorized to fix its remuneration.
Thank you, Ms. Williams. I second all of Ms. Williams' motions. Mr. Secretary, are there any questions or discussions on this motion?
There is no discussion at this time.
As there is no discussion, I'll now call for a vote on the motions before the meeting. As previously mentioned, voting today will be conducted by ballot. The ballot has been open since the beginning of the meeting, and at this point, all registered shareholders and duly appointed and registered proxy holders who have properly logged in with their control numbers and wish to vote should make their way to the Vote tab located on the left side of their screen. There, they will be able to see on the screen all the items put forward before this meeting. The voting will remain open for an additional 30 seconds. Once the ballot closes, the voting page will disappear and your votes will automatically be submitted. Now, before announcing the voting results,
Mr. Secretary, is there any other business that any shareholder or proxy holder present wishes to bring to the attention of the meeting?
There is no discussion at this time.
Thank you. If there is no further discussion or no further business, I'll now declare the ballot closed, and we will proceed to present the voting results. I will now ask the secretary to provide the preliminary results of the scrutineer's tabulation of today's votes.
Thank you, Mr. Chairman. The scrutineers confirmed the following preliminary vote results. Each of the director nominees received the required percentage of votes for, and the percentage of required votes are favorable to the appointment of PricewaterhouseCoopers LLP as auditor for Medicenna Therapeutics Corp. for the fiscal year ending March 31, 2023.
Thank you. I declare each of the resolutions considered at today's meeting in respect of those matters as carried. The full voting results will be published on SEDAR and EDGAR following the meeting. That concludes the formal business of this annual meeting of the shareholders, which I now declare closed. I will now provide a brief corporate overview for any shareholders interested.
Mr. Chairman, you may proceed with the presentation.
Okay. Thank you. The presentation today will talk about Medicenna's programs, namely our evolutionary cytokines that are being developed to generate revolutionary medicines. Can we go to the next slide, please? I will be making forward-looking statements and therefore encourage you to look at our filings regarding risks, etc . Thank you. Can we go to the next slide? So as you know, Medicenna is really focused in a number of areas of developing engineered Superkines. Our program that is currently generating data is around our MDNA11 program. This is a project that we'll talk about today. But nevertheless, I will focus on first and foremost saying that the company itself has a broad pipeline of Superkines. These comprise of Interleukin -2, Interleukin -4, and Interleukin -13 as molecules that form the basis of our platform. These are, as I mentioned earlier, engineered cytokines.
The first molecule that I'll talk to you about is MDNA11. MDNA11 is an IL-2 superagonist that has been designed specifically to target and stimulate the cancer-fighting immune cells that are necessary in order to control tumors and therefore also modulate the tumor microenvironment. We have those results and share with you those results today around MDNA11. Importantly, we also have a second program, namely MDNA55, which has completed phase 2B clinical trials for recurrent glioblastoma with encouraging results. As I mentioned to you before in the past, that the company is looking to proceed with partnering this particular project so the company can, or a partner can complete a phase III registration trial and subsequently commercialize the product. Finally, we have a discovery platform known as the BiSKITs platform.
This particular program itself is in early stage of development, but clearly, a really exciting space to develop, novel therapeutics that contain two different molecules that act together and cause synergistic benefit, all included within a single molecule. Next slide, please. As I said before, the company is really following and progressing its assets around the Superkine platform, and our focus has been limited to three different Superkines, namely IL-2, IL-4, and IL-13. These can be engineered using a technique known as directed evolution, and this approach allows us to engineer these Superkines in a unique manner so we can either stimulate the cancer-fighting immune cells or we can take highly overactive immune systems. For instance, in patients that might have, let's say, autoimmune disease, that have a hyperactive immune system.
We can use our Superkines to actually tone these hyperactive immune systems and calm them down. At the same time, in patients that have cancers, we can engineer these Superkines so that these Superkines stimulate the cancer-fighting immune cells. We have a lot of potential for developing multiple programs and therefore an exciting pipeline of molecules in the coming years. Go to the next slide. As I said, we'll focus first and foremost on MDNA11. MDNA11, as you know, is our program that is currently enrolling patients in the phase I/II clinical trial, looking at treating patients with various different kinds of solid tumors. Next slide. Now, why MDNA11? MDNA11 comes from a molecule that was the original molecule that we in-licensed from Stanford University. We call that molecule MDNA109.
The reason we've developed this molecule is that, IL-2 is a cytokine that is known. In fact, it has been approved for treating patients with melanoma as well as kidney cancer for the past 20 years. The problem with Proleukin, which is the commercial name for this particular molecule, is that it is highly toxic. It is a molecule that potentially causes life-threatening side effects. also this molecule has a relatively short half-life, so patients have to be administered this drug three times a day for five days continuously and in an intensive care unit. Now, there has been promise with Proleukin in the sense that it does provide long-term benefits to about 10%-15% of the patients that have melanoma or renal cell carcinoma, it has not shown any benefit in other different types of tumors.
As I said, it's difficult to administer due to the safety issues, and it has a very short half-life and therefore requires multiple administrations. MDNA109 has been engineered so that this particular molecule has a unique set of properties that make the molecule a lot safer in the sense that it will bind and stimulate cancer-fighting immune cells. It does not bind to a certain receptor known as the alpha receptor, which is the cause for toxicity. Going on to the next slide, what we have is the opportunity here, as you can see. This particular space has resulted in multiple transactions, as you see on this particular slide deck.
In 2018, Nektar Therapeutics entered into a $3.6 billion transaction with Bristol Myers Squibb, and this particular transaction occurred at a time when Nektar Therapeutics was conducting a phase II clinical trial with their IL-2. Subsequently in 2019, as Synthorx was conducting its clinical trial, a phase I clinical trial with their version of IL-2, Sanofi acquired Synthorx for $2.5 billion. Also, early last year, Merck acquired Pandion Therapeutics that was developing an IL-2 specifically for treating patients with autoimmune disease, and that again occurred when Pandion was conducting a phase I clinical trial. More recently, in fact, just this month, Roche acquired Good Therapeutics as it was in preclinical trials developing its IL-2-based bispecific molecule fused to an anti-PD-1 molecule. These are good examples as to why we feel that IL-2 is an exciting space to be in.
More importantly, we believe that our IL-2 is substantially superior to those of other competitors that you see on this slide, and as you will see on the next slide as well. Next slide, please. Here we show how MDNA11 compares with other IL-2 molecules that are in the clinic or are in early stages of development. I believe each one of those that are listed on this particular slide have all entered the clinic or just started clinical trials very recently. Across the board, what you see on this particular slide is that MDNA11 provides substantial benefits across the range of issues that cause Proleukin or IL-2 toxicity, short half-life, and lack of efficacy.
We feel that these key characteristics that we have been able to achieve with MDNA11 with respect to, first and foremost, not binding to the alpha receptor, which is responsible for toxicity, but also to stimulate cancer-fighting immune cells. Its ability to substantially enhance binding to the beta gamma receptor, which is necessary for this particular molecule to stimulate only the cancer fighting immune cells. As you can see across the board, MDNA11 together with Neoleukin are the only two companies pursuing that route. Third is that our molecule has been engineered, so it's fused to an albumin, making the molecule large. Instead of administering the drug three times a day for five days, our drug, we can administer this once every two weeks or potentially even once every three weeks. A key advantage.
Fourth is that our molecule is the only molecule that has been fused to albumin. What albumin offers us is that albumin allows the drug to stay in the bloodstream much, much longer. Second, as we've shown in our work, and others as well have shown that albumin molecules tend to accumulate in the tumor. They tend to accumulate in the lymphatic system, in the lymph-draining lymph nodes, where there is the majority of immune cells or cancer-fighting immune cells. That is a very unique approach unlike anybody else. Then finally, unlike others that use PEGylation techniques to extend half-life, Medicenna does not use PEGylation and therefore we are not encumbered by all the disadvantages of PEGylation. I won't go through any preclinical data. These have been reported in the past.
There's lots of data on our website, but I'll give you an update on where we are with our clinical trials. Going on to the next slide. As you know, we are conducting the phase I/II ABILITY study, and this particular study comprises three different portions of the trial. The first on the left is, which is typically a phase I portion, where the intent is to identify the safe dose for patients that would receive MDNA11 in the future. In this scenario, what we do is what we call a dose escalation portion of the trial, where patients are administered starting from the lowest dose from 3 mcg per kg and continue to increase the dosing until we get to a stage where the dosing causes dose limiting toxicities.
In which case we are then able to identify what we call a recommended phase II dose. Mind you, the first portion of this clinical trial is intended to develop and identify the right dose, determine the pharmacokinetics of the drug, the safety profile of this drug in patients that are extremely sick, who have basically failed all therapies and are at end stage of the disease. This is something that we are currently enrolling patients in. As you can see on this slide, we've increased the dosing from three to 10 to 30 to 60, and now enrolling patients at the 90 mcg per kg dose. That's where we are at the moment, and I'll share some of the results that we have obtained from the first four cohorts. The second portion of the trial is a dose expansion portion of the trial.
This is where all the patients would receive the recommended phase II dose and the recommended dosing schedule so that everybody or all the patients in this portion of the trial receive similar treatment regimen. Unlike the first portion of the trial, where patients with different types of tumors, with different background and prognostic factors receive different doses and different schedules of MDNA11. Here in this dose expansion phase of the trial, we are continuing to monitor safety and tolerability, but we will have a much better opportunity to demonstrate and examine MDNA11's potential single agent activity in terms of any efficacy data, in terms of tumor shrinkage, survival, et c., that we want to see. Finally, the third portion of the trial is to combine MDNA11 with a checkpoint inhibitor. The checkpoint inhibitor that we are pursuing with is KEYTRUDA.
As you all know, that we recently announced a clinical collaboration with Merck that will allow us full access to their drug at no cost, together with their expertise in working together to develop an optimal dosing regimen in combination with a checkpoint inhibitor. Again, this will be at a set or fixed dose of both MDNA11 and the checkpoint inhibitor once an initial safety run-in period is completed. It's a comprehensive program. We expect to complete all these studies next year and have the bulk of the data before the end of next year for all these clinical studies. With respect to the dose escalation portion of the trial, we have, as you know, completed the 60 mcg per kg dose, and therefore, I will be able to share some data up to that dose. Going to the next slide.
Here what we have first and foremost is data from the different doses that we've administered to the patients with various different kinds of tumors. What we can clearly see here is that as we increase the dosing from 10 to 60 mcg per kg, what we're seeing is that the higher doses, we are substantially increasing the population of circulating cancer-fighting immune cells, as you see here with what we call the lymphocyte population. This is giving us encouraging data. What is really important to see here is that upon administration of MDNA11, we see that the effect of the drug in terms of stimulating the lymphocyte population lasts at least two weeks. That allows us to administer the drug every two weeks, unlike Proleukin or other approaches where the drug is administered more frequently. Next slide.
In the next slide, what we show here is that unlike Proleukin, which tends to substantially increase the population of cells known as eosinophils. Eosinophils, in turn, cause a rather life-threatening side effect known as vascular leak syndrome. Very encouraging with our results so far is that despite the fact that we've increased the dosing from 10-60 mcg per kg, in the patients that have received MDNA11 so far, we are not seeing signs of what we call eosinophilia, and therefore, encouraged to see that we are able to continue to dose escalate without seeing any dose-limiting toxicities associated with vascular leak syndrome. Next slide. Finally, important data here that we have today, of course, the dose escalation portion of the trial is not intended to demonstrate efficacy of the drug.
We expect that to be coming through to us from the dose expansion phase, where we'll have a better selection of patients, et c. Nevertheless, it is encouraging to see that as we dose escalate, we've not seen issues with dose-limiting toxicities. As you can see, we're treating patients with a variety of different tumors, not only melanoma or renal cell carcinoma, but also patients with sarcomas, pancreatic cancer, as well as different types of squamous cell carcinomas of the tonsil, of the gastric, or the esophageal locations of these particular tumors. A number of these tumors currently do not respond to immunotherapies like checkpoint inhibitors, et c., including the patients with renal cell carcinoma, for instance. Although MDNA...
Although Proleukin has been approved for renal cell carcinoma, it is not used in patients that have what we call non-clear cell renal cell carcinoma. The majority of patients, other than melanoma patients in this particular study to date, do not benefit from checkpoint inhibitors. In fact, of the 14 patients that are on this list, 11 of those 14 patients have already failed the treatment with not only one, but in some cases two or three different types of checkpoint inhibitor therapies or combinations of these checkpoint inhibitors. Clearly, these patients are end-stage patients, and the bulk of them have gone through anywhere up to four different lines of therapies, plus multiple radiations and surgical procedures, et c.
What we see here is that signs of therapeutic activity of MDNA11. We see that of the 10 evaluable patients for whom we have at least one post-treatment scan, four of these patients have tumor control, namely meaning the tumor has stabilized or is showing signs of response. We have, as we announced earlier last month, that we had one unconfirmed partial response in a patient with pancreatic cancer. In the next coming days, we continue to collect data from the remaining four patients in cohort four, as well as the pancreatic cancer patient and the patient in cohort two, which is a melanoma patient, who started out at 10 mcg per kg, which is dose level two. That patient demonstrated stable disease all the way to week 24 and was then subsequently received a higher dose of 30 mcg per kg.
More recently, this patient is now receiving the 60 mcg per kg dose. This patient now, as you can see, nearly a year out into the study, showing that MDNA11 treatment is providing a durable tumor control in this particular patient. Really encouraging is to see for the first time that a drug such as MDNA11, or for that matter, any IL-2, is showing activity against pancreatic cancer, a highly aggressive form of cancer. We expect to provide an update on the results from this particular clinical trial once we get scans from all these patients, and we plan to report those data next week. Going on to our next program, which is MDNA55. This is a program, if you go to next slide. Sorry, you can go one more slide ahead.
What we see here is that, and we reported this data multiple times before, what we are showing with MDNA55 is that a single administration of MDNA55 in patients with recurrent glioblastoma, a type of tumor that is by far the most aggressive kind of brain cancer, is we are able to demonstrate a doubling of median survival. The expected survival of patients with recurrent glioblastoma is anywhere between six and nine months. In our control arm, we found that the median survival was just 7.2 months. We find with MDNA55, a single administration provides a survival improvement which is 100% higher, namely 15.7 months, compared to the control arm. Going to the next slide.
Our end of phase II meeting with the FDA was important and by far, in fact, the very first time the FDA has ever agreed on conducting a phase III trial where the majority of patients in the controlled trial will come from an external database. This particular design has been approved by the FDA and we look forward to now entering into a partnership with a pharma company that can conduct the registration trial and subsequently also have the ability to market and launch the product into the marketplace for patients that need this kind of therapy. With that, let me go to the last slide and give you an update as to what are the key milestones coming up. As I said to you, just a few minutes ago, the fourth dose cohort patient scans are expected in the coming days.
Next week, we will report the data on this particular cohort of patients. This would include the patient with pancreatic cancer. At the end of this year, we will have the opportunity to provide initial data on the fifth dose cohort, which is the 90 mcg per kg dose cohort. We're expecting that early next year we'll be able to start the monotherapy dose expansion portion of the trial, where the intent will be not only confirm the safety of the drug, but also collect more efficacy data in a patient population that is much better defined, unlike the phase or the early portion of the trial. We'll expect to have data from that particular portion mid-2023, and by the end of next year we'll have data from a combination part as part of the collaboration we have with Merck, with KEYTRUDA.
All in all, really excited with the number of milestones coming up in the coming quarters. We are particularly happy that we were able to raise additional capital in these very challenging markets to be able for us to achieve each of these milestones and beyond, so that we are able to advance not only MDNA11, but our earlier stage programs as well. As you all know, we are listed both on the TSX and Nasdaq. We are headquartered in Toronto. As of our last quarter, we had CAD 19.3 million in the bank. We subsequently raised about $20 million, and that gives us sufficient runway well into 2024. We have no debt, no preferred shares. Really simple structure with issued and outstanding shares of 70 million, with on a fully diluted basis, 92 million shares.
Looking forward to reporting more data in the coming quarters. I would like to thank you all for attending this AGM and listening to this presentation and your support as shareholders. Thank you, and I will stop here.
Ladies and gentlemen, thank you for attending today's meeting. You may now disconnect.