Medicenna Therapeutics Corp.

Hello, and welcome to the Medicina Therapeutics Fiscal Q2 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. Please be advised 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. Please go ahead.

Thank you, Operator. and thank you all for participating in today's conference call. This morning, Medicina issued a press release providing financial results and corporate updates for the quarter ended September 30th, 2021. If you have not yet seen the press release, it is available on the investors page of Medicina'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 and 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 the MDNA 11, MDNA 55, and BISCUITS programs, the potential of the SuperKind platform, partnering activities, cash runway, and the presentation of additional data. All statements other than statements of historical fact included in this conference call, including the future plans and objectives of the company, 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 40F 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. Now, I will turn the call over to Dr. Fahar Merchant, President and Chief Executive Officer of Medicina Therapeutics. Fahar.

Thanks, Dan, and thanks to those who have joined us today to discuss our fiscal Q2. 2022 Corporate Update. In addition to Dan, I am joined by Dr. Man Musin, our Chief Medical Officer, Nina Merchant, our Chief Development Officer, and Liz Williams, our Chief Financial Officer. This is an exciting time for Medicina as our accomplishments over the past months have us advancing towards key positive inflection points with the potential to differentiate our IL-2 program and provide clinical validation of our SuperKind platform. Today, we will review some of these recent accomplishments, outline our clinical and corporate strategy, and set the stage for what to expect over the coming months by discussing the clinical, scientific, and corporate objectives we are working towards. So, let's start with some of our recent accomplishments, beginning with our MDNA 11 program. As a reminder, MDNA 11 is our beta-only, long-acting IL-2 super agonist that we believe is well-positioned to be a best-in-class cytokine in the immunotherapy treatment landscape. Last quarter, we initiated our Phase 1-2 ability study of MDNA 11, expanding our clinical pipeline. Patient dosing in the trial is currently underway in Australia. And we recently received IND clearance from the FDA to expand the trial to the United States. In addition, we are planning to further expand the study to sites in Canada and the United Kingdom and expect regulatory submissions for these jurisdictions to be complete before the end of the calendar year. While I let Matt speak in more detail about the trial, I will say now that we are very pleased with the progress being made and remain on track to provide a preliminary update on safety, PKPD, and biomarker data from patients in the early cohorts enrolled in the dose escalation phase of the study by the end of calendar 2021, as well as an initial efficacy data update from the dose escalation portion of the study by mid-2021. The update in calendar 2021 will be an important check to confirm that the best-in-class properties we see in our murine and non-human primate studies are being replicated in humans, which we believe will correlate for more efficacious drug when compared with other IL-2 variants in clinical development. Staying with our MDNet11 program, We also recently reported data from murine and IND-enabling non-human primate studies at the triple meeting. These data reinforce our belief that mDNA11 has the potential to be a best-in-class therapy and highlight the advantages of its differentiated beta-only approach to selectively target this key IL-2 receptor subunit. Non-human primate data indicate that mDNA11 may overcome the safety and PK challenges of recombinant human IL-2, which is known as proleukin, and approved for the treatment of advanced renal cell carcinoma and metastatic melanoma. They also show that by selectively targeting the IL-2 receptor beta subunit and avoiding the IL-2 receptor alpha unit, MDNA11 preferentially induced durable proliferation and expansion of anti-cancer immune cells with limited stimulation of pro-tumor Treg cells. We believe this beta-only activation of the IL-2 receptor will translate to enhanced efficacy in comparison to proleukin and not alpha IL-2 versions that are in the clinic. In a murine colon cancer model, data showed that MDNA11 alone or in combination with an anti-PD-1 checkpoint inhibitor led to tumor growth inhibition and dose-dependent durable complete responses in all mice, even though tumor growth rate was not inhibited by anti-PD-1 monotherapy. Additionally, initial treatment with MDNA 11 alone, or in combination with anti-PD-1, provided long-term protection against subsequent tumor re-challenge by inducing antigen-specific memory CD8 T cells. We believe these collective results, which mine will be discussing in more detail shortly, provide a strong scientific rationale for our ability study, and highlight the potential of MDNA11 to overcome the shortcomings associated with Prolucan and competing not-alpha IL-2s in the clinic. Shifting gears, I'd like now to briefly discuss MDNA55, which is our Phase III-ready, empowered IL-4 superkind being developed as a treatment for recurrent glioblastoma. As some of you may recall, our Phase IIb trial showed that a single treatment with MDNA55 led to a doubling in the overall survival when compared to a matched external control arm. Based on these and other data, we have aligned with the FDA on an innovative hybrid Phase III trial design that allows for two thirds of the control subjects to be from a matched external control arm. This trial design was recently featured in a peer reviewed manuscript published in the Lancet Oncology and in an oral presentation at the Society for Neuro-Oncology and American Society of Clinical Oncology's first annual conference on CNS clinical trials. We have recently secured the FDA's agreement on deferring any pediatric clinical trials with MdNA55 to occur only after the adult phase three trial is completed, instead of having to conduct a pediatric study in parallel with the adult study. This approach substantially de-risk the conduct of the registration trial in adults by the potential partner. In the interim, We continue to advance the required regulatory activities associated with MDNA55, GMP manufacturing, and future commercial supply for potential market launch so that the program can be advanced as efficiently as possible once a partnership is established. On the discovery and preclinical effort, last quarter we were pleased to announce a peer-reviewed publication in Frontiers in Immunology, featuring data on MDNA-109, which is our IL-2 supercrime platform and the precursor of MDNA-11. This paper, which was independently authored by researchers at the University of Helsinki and other institutions, evaluated oncolytic adenoviruses that were either unarmed, armed to code for MDNA-109, or armed with wild-type IL-2 in a hamster pancreatic cancer model. Results showed that compared to wild-type IL-2, MDNA-109 was better able to reprogram the tumor microenvironment, which led to superior tumor growth inhibition with an MDNA-109-armed virus compared to an IL-2-armed virus in a pancreatic tumor model. These and other results from the paper externally validate the versatility of the MDNA-109 platform and its potential to overcome limitations associated with less active versions of IL-2, such as native IL-2, particularly in immunologically cold tumors, such as pancreatic cancer, where a great unmet need exists today. Going forward, we expect the versatility offered by our Superkind platform to continue to power our discovery and preclinical programs as we seek to develop next-generation Superkind-based therapies such as those derived from our BISCUITS platform. As a reminder, our BISCUITS platform enables the design of bespoke immunotherapeutic agents that incorporate two functionally non-overlapping mechanisms of action so as to potentially achieve synergistic therapeutic effects. This may allow for the treatment of more aggressive and recalcitrant tumors where a simultaneous two-pronged approach may be necessary to improve safety and efficacy. Biscuits comprise a super kind that is then fused to a second anti-cancer agent such as another super kind, an antibody, or a checkpoint inhibitor. An example of a biscuit comprising two super kinds is MDNA19-413, which is another promising long-acting therapeutic candidate that combines an IL-2 super agonist with an IL-4, IL-13 super antagonist to potentially overcome tumor resistance mechanisms to immunotherapies and can be a viable treatment option for immunologically cold tumors. Examples of biscuits include fusions of our IL-2 super kinds with checkpoint inhibitors such as an anti-PD-1 antibody in the cis mode or an anti-PD-L1 antibody in the CRANS orientation. These agents can potentially provide superior anti-tumor effect compared to traditional checkpoint inhibitors in monotherapy settings by enabling T cell activation while simultaneously stimulating pathways to suppress T cell exhaustion and inhibiting tolerance of the immune system to tumor cells and antigens. They may also offer important intellectual property advantages and crucial life cycle management and patent extension as first-generation checkpoint inhibitors begin to come off patent in the coming years and highlight one of the key advantages of our SuperKind platform. Unlike others who utilize inefficient chemical synthesis or conjugation techniques, such as pagulation to improve pharmacokinetic profiles of cytokines, our SuperKind platform is independent of such manufacturing challenges and instead uses protein scaffolds such as albumin, as is the case with MDNA11. Our highly selective and tunable super kinds and biscuits are generated using directed evolution, allowing them to be genetically fused with other biologics such as targeting antibodies, checkpoint inhibitors, other cytokines, or they can be used to arm oncolytic viruses, CAR T cells, and cell-based therapies to further enhance their efficacy. These versatile options are not available with pegylated IL-2s. Our manufacturing platform simplifies the scalability of the manufacturing process and leads to improved IL-2 receptor beta binding affinity compared to pegylated IL-2, further differentiating our superkind and BISCUITS platform from competing approaches. Finally, using albumin as a scaffold has the potential for localizing our superkinds to the tumor microenvironment and tumor-draining lymph nodes, which function as sites of T-cell invigoration required for immunotherapy and checkpoint blockade. Looking forward, we remain committed to our BISCUITS program, given its potential to create fusions with antibodies, other super kinds, and checkpoint inhibitors, and we are currently advancing multiple candidates through the discovery and optimization process. We plan to conclude the candidate selection and declare a lead candidate by the end of the calendar year. In addition to our recent clinical and scientific accomplishments, we also strengthened the intellectual property portfolio, protecting our SuperCAN platform with the issuance of a U.S. patent. This patent covers methods of treating a wide range of cancers with IL-2 variants, such as MDNA-11, and has claims that specifically focus on agents with enhanced affinity for IL-2 receptor beta, which, as I mentioned earlier, is a key point of differentiation for our IL-2 super kinds. This latest patent adds to a long list of issued and filed patents in major jurisdictions around the world, which collectively provide foundational composition type protection for MDNA 11 and our broader IL-2 super kind platform. Lastly, before handing the call off to Man, I'd like to highlight an important corporate accomplishment from last quarter, which was the appointment of Dr. John Sampson for our board of directors. John is an immunology expert who brings extensive experience in clinical trial design and execution to our board, as well as deep knowledge of the regulatory process. He is currently the Robert H. and Gloria Wilkins Distinguished Professor of Neurosurgery at Duke University, President of Duke's Physician Practice Private Diagnostic Clinic, and a member of the prestigious National Academy of Medicine. The insights he has provided have already proven to be valuable, and I look forward to his continued contribution to MediCenter's long-term growth and clinical strategy. And with that, I will hand the call off to Man to provide some more details on our MDNA 11 program. Man, please go ahead.