Medicenna Therapeutics Corp.

Hello, and welcome to the Medicenta Therapeutics Fiscal Year End Earnings Call. All participants are now in a listen-only mode. There will be a question and answer session at the end of this call. If anyone should need operator assistance during the conference, please press star zero on your telephone keypad. 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. Dan, please go ahead.

Thank you, operator, and thank you all for participating in today's conference call. This morning, MetaSena issued a press release providing financial results and corporate updates for the fiscal year ended March 31st, 2022. If you have not seen the press release, it is available on the investor's page of MetaSena'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 MDNA 11, MDNA 55, and the BISCUITS programs, potential of the Superkind platform, partnering activities, 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 recently filed annual information form, management's discussion and analysis in Form 20F, of the company and 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. Now, I will turn the call over to Dr. Fahar Merchant, President and Chief Executive Officer of Medicina Therapeutics. Fahar?

Thank you, Dan, and thanks to all of you joining us on today's call. In addition to Dan, I'm joined by Dr. Martin Baxson, our Acting Chief Medical Officer, and Liz Williams, our Chief Financial Officer. With the considerable progress made in the past fiscal year, we believe that we are now at the cusp of what is an exciting and pivotal time for Medicina. This is being driven by the progress we have made with initiation and advancement of the Phase I-II Ability Study in patients with advanced solid tumors, which is the first clinical study of our differentiated beta-only long-acting IL-2 super agonist, mDNA11, and the promising signs of clinical activity we are reporting in the early stage of our dose escalation portion of the trial. During the past 12 months, despite being in the midst of a global pandemic, we completed all of the CMC activities associated with GMP-compliant manufacturing of mDNA11 for the Phase I-II Ability Study, the IND-enabling studies required for regulatory submissions to commence first in human clinical trials with mDNA11, and a secured clearance of the various applications submitted to regulatory agencies in Australia, US, and Canada. As a result, we are well underway in our dose escalation portion of the Ability Study and continue to enroll patients at multiple clinical sites in diverse geographic regions to establish the recommended Phase II dose for the dose expansion phase of the study, both as a single agent and in combination with a checkpoint inhibitor. We have continued to also build our pipeline of new long-acting IL-4 and IL-13 super antagonists, as well as our bi-functional super kinds for immunotherapy or biscuits, such as the NTPD1-MDNA19 cis-targeting fusion protein. Furthermore, we have completed a comprehensive commercial opportunity analysis of our MDNA55 program for treatment of recurrent glioblastoma and other brain cancers. With compelling clinical data and an attractive registration pathway, MDNA55 scored highly among KOLs in Europe and the U.S. and was rated very favorably by payers for reimbursement based on projected pricing. We look forward to a positive outcome as we advance our discussions with interested parties. Finally, we close the year end with a strong cash balance of $20.5 million and have made modifications to our budget in order to extend the cash runway well into Q2, calendar 2023, taking us well past our anticipated first substantial clinical efficacy readouts from the Ability Study. In the Phase I-II Ability Clinical Study of MDNA11 in patients with advanced and megastatic solid tumors, the primary objectives are to investigate safety and tolerability and determine the recommended Phase II dose, while the secondary objectives are to evaluate pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity in both the monotherapy, and the combination arms of the study. Since dosing the first patient in the Ability Study this past September, we have observed very encouraging data in the first three dose escalation cohorts, consistent with MDNA 11's anticipated differentiation from competing IL-2 programs. MDNA 11 is demonstrating an acceptable safety and tolerability profile as well as promising early signs of clinical activity in the first eight patients while dose escalation continues to enroll in cohort four. Although it is too early to draw meaningful conclusions on efficacy potential of MDNA 11 from the dose escalation portion of the clinical trial, we have seen very encouraging signs of CD8T and NK cell activation and proliferation in the periphery in most patients treated so far, as well as early signs of tumor control in three out of eight patients. Further, the PD data was from peripheral blood sampling and we expect that this PD data may have a different profile and durability of activation of cancer-fighting immune cells in the tumor and the tumor-draining lymph nodes. Given that the therapy is well-tolerated, as we escalated from 3 micrograms per kilogram in cohort 1 to 30 micrograms per kilogram in cohort 3, MetaCena has implemented a step-up dosing regimen in all subsequent dose escalations. Cohort 4 is currently enrolling at the target dose of 60 micrograms per kilogram following two priming doses at 30 micrograms per kilogram. As we continue to escalate, we could see different dynamics emerge at higher doses. We therefore look forward to data updates throughout 2022 for more safety, PK, PD, and efficacy data. In the second half of 2022, we expect more fulsome data for MDNA11 as well as early data from the single-agent dose expansion cohorts in a restricted number of tumor types, such as metastatic melanoma and advanced renal cell carcinoma. Management expects approximately 10 more patients in the dose escalation portion of the study, in addition to 13 patients already enrolled to date in cohorts 1 to 4. With encouraging PKPD and safety data, and early signs of tumor control in three out of eight patients in cohorts one to three, we expect more meaningful signals of efficacy at higher doses as we continue with the dose escalation portion of the ability study. As the ability study has advanced over the past fiscal year, we have been consistently monitoring the data it has generated, changes in the regulatory environment, as well as data reported from clinical trials of other IL-2 variants. Although recent clinical results from trials of pegylated IL-2 have not shown clinical efficacy, it is important to note three key points. First, IL-2 is a validated target that when administered at high dose, it is known to drive meaningful clinical benefit. MDNA 11 is clearly differentiated from these competing agents in ways that we expect will translate to superior efficacy. The data we have seen from the Ability Study supports this view, which is a topic Martin will cover in more detail. And third, we have the benefit of leveraging the learnings from recent trials of competing IL-2 variants to optimize our clinical development plans in a data-driven manner to increase our chances of success. One of these learnings comes from early safety data that shows modest adverse events such as fever or chills being more prevalent after the initial dose of MDNA 11 than after subsequent doses. Based on this observation in the clinic, and in non-human primate studies, and to ensure we are able to achieve a maximum MDNA 11 dose before reaching dose-limiting toxicities, we are utilizing a step-up dosing strategy from cohort 4 onwards. This strategy entails first treating patients with two priming doses to habituate them to MDNA 11 before stepping up to the higher fixed dose that is being evaluated. This is expected to increase our chances of identifying MDNA11's optimum dose and is in line with FDA's recently released Project Optimus initiative, which encourages companies to do more early on in clinical development to find the optimal dose for oncology drugs. Given the dose-dependent PD effects, and early signs of clinical activity, MDNA 11 has displayed thus far in the ability study, ensuring that we are able to identify its optimum recommended phase two dose will further improve our chances of clinical success. A failure to reach the optimal dose is something that may have hampered other IL-2 programs such as the pegylated variant I mentioned earlier. While the step-up dosing regimen we are pursuing with MDNA 11 will allow us to achieve higher doses and position the ability study for success, it does take longer to dose each patient as two priming doses are required before administering the target dose. This has impacted our follow-up period for each patient to eight weeks instead of four weeks when using the fixed-dose approach. Thus, enrollment in the fourth and subsequent cohorts will take longer and delay our ability to collect patient scans following the target dose. We expect updated PKPD data from cohort 4 in July 2022, first follow-up CT scans at the higher dose cohort 4 in Q3 of calendar 2022, with a full set of efficacy data for all dose escalation cohorts in Q4 of calendar 2022. To help ensure the MDNA 11 program is advanced as efficiently as possible, we made it a point this past fiscal year to assemble world-class advisory councils, including our development advisory committee and scientific and clinical advisory boards. These include some of the world's leading experts on drug development and cancer immunotherapy, which allows us to gain invaluable insights and complementary perspectives on our drug discovery and development efforts. These have been crucial to the advancement of not only MDNA 11, but also to the advancement of our preclinical stage super kinds and biscuits. We recently highlighted two of these preclinical assets in posters at the AACR meeting this past April. One poster focused on FC-MDNA413, which is derived from our superkind platform and consists of an IL-13 super antagonist fused to the FC domain for half-life extension. And the second poster featured a preclinical candidate from our BISCUITS program. As a reminder, BISCUITS are bifunctional superkinds. designed to combine two distinct and synergistic immunotherapy mechanisms of action into a single molecule. This poster outlined preclinical studies on a biscuit consisting of an anti-PD-1 antibody linked to an IL-2 super agonist similar to MDNA-11. We believe our ability to incorporate checkpoint inhibitors, which are widely successful commercial drugs, into novel biscuits may provide important intellectual property advantages as the first generation of checkpoint inhibitors come off patent. This in turn could spark valuable collaborations with the leading developers of these agents. Over the past 12 months, we have seen that some of the world's renowned academic labs have independently published results demonstrating the exceptional potential of our core MDNA-109 IL-2 superkind platform when incorporated in oncolytic viruses, CAR-T-based therapies, conditionally activated superkinds, or when combined with sting agonists. This provides external validation of our superkind platform, especially the MDNA-11 asset. Looking forward, we expect the continued advancement of our preclinical superkinds and biscuits and to provide important value creation opportunities to supplement our lead MDNA 11 program. With that, I will now turn the call over to Martin to discuss the Ability Study status, research data, and future outlook. Martin?