Medicenna Therapeutics Corp.

Hello and welcome to Medicina Therapeutics Fiscal Year 2021 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. Earlier today, Medisena issued a press release providing financial results and corporate updates for the fiscal year ended March 31, 2021. If you have not seen the press release, it is available on the Investors page of Medisena'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 analysis and form information, 40F 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. The reader is 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'll turn the call over to Dr. Fahar Merchant, President and Chief Executive Officer of Medicina Therapeutics. Fahar.

Thanks, Dan, and thanks to all listening for joining us on the call today to discuss our fiscal year 2021 corporate update. In addition to Dan, I'm joined by Dr. Man Musin, our Chief Medical Officer, Dr. Kevin Mulder, our chief scientific officer, Nina Merchant, our chief development officer, and Liz Williams, our chief financial officer. Fiscal year 2021 was Medicina's strongest and most productive year yet, despite the unpredictable environment caused by the pandemic. We achieved key clinical, scientific, and corporate milestones that have left us well positioned for sustained success. On today's call, we will review some of these recent accomplishments, give an update on the current status of our pipeline programs, introduce the new members of our executive team, and provide an outlook for fiscal year 2022 and beyond. So let us start with some of our accomplishments over the past year, beginning with our program focused on MDNA11, our long-acting IL-2 super agonist. Mindstones in this program include the presentation of non-human primate data showing that MDNA11 selectively stimulates prolonged expansion of anti-cancer immune cells without causing unwanted side effects, such as the generation of anti-clog antibodies, hypotension associated with vascular leak syndrome, or cytokine release syndrome. We also presented additional preclinical data that further highlighted MDNA11's best-in-class potential by demonstrating its durable and potent therapeutic efficacy both as a monotherapy and in combination with checkpoint inhibitors in murine tumor models. To prepare for the initiation of a clinical study in 2021, We completed our scientific advice meeting, which is similar to a pre-IND meeting with the United Kingdom Medicines and Healthcare Products Regulatory Agency. During the meeting, the agency agreed that our CMC preclinical and phase 1 to 8 clinical plans would be appropriate for submission of an investigational medical product dossier for a first in human study with MDNA 11 in the UK. In addition, we are on track to submit a clinical trial notification to the Australian Human Research Ethics Committee this quarter in order to commence the Phase 1-2A clinical trial of MDNA 11 in the third quarter of calendar 2021. Man will provide more information on our MDNA 11 clinical plans in the next few minutes. I'd now like to turn our attention to MDNA55, our IL-4 guided toxin targeting recurrent glioblastoma, or R-GBM, the most common and uniformly fatal form of brain cancer. Throughout the past year, we presented updated data from our Phase IIb trial in R-GBM that demonstrated MDNA55's potential to change the treatment paradigm in a high unmet need indication. These data showed that amongst an all-cover population, a single MDNA 55 treatment resulted in a greater than 100% increase in two-year survival compared to an eligibility-matched external control arm and a greater than 100% improvement in progression-free survival compared to what is achieved with approved therapies. Thanks in large part to the robust external control arm study we conducted, the substantial magnitude of the effect observed in the Phase IIb trial, as well as the significant unmet medical need in RGBM, the FDA recommended we conduct a landmark Phase III trial to support MDNA55's approval in this indication. This planned trial has an open label hybrid design that allows for two-thirds of the control subjects to be from a matched external control arm. This was truly pioneering recommendation by the agency, and to the best of our knowledge, this groundbreaking design may be the first in oncology to include a substantial external control arm in a trial designed to support regulatory approval. I will talk more about this trial as well as a recent publication featuring our Phase IIb data in a short while. But we'll say now that we remain in active discussions with potential partners to facilitate MDNA55's advancement. While the details of these conversations need to remain private at this point, We look forward to providing a more thorough update on these activities when appropriate. On the discovery and preclinical front, we also recently unveiled our bispecific superkind platform, which we refer to as BISCUITS. These novel molecules, which are fusions of two complementary superkinds or a superkind and an antibody, such as a checkpoint inhibitor, have the potential to address critical unmet needs such as the treatment of cold tumors that do not typically respond to current immunotherapies. We recently presented some very exciting early data from this program at AACR, which Kevin will discuss later in this call. Now, alongside our scientific and clinical accomplishments, We also achieved notable corporate milestones during fiscal 2021, such as our listing on NASDAQ and the strengthening of our board via the addition of Dr. Jack Zaltoski. This corporate momentum has continued into fiscal 2022, as we recently added Man and Kevin, two highly talented immunooncology experts to our management team. As I will tell you in a few moments, our ability to recruit such ideal candidates was due in large part to the clinical and scientific milestones I just mentioned, which showcased the best in class and first in class potential of our assets together with the power and versatility of our super kind and biscuits platforms. I will now let you hear from these team members. starting with our chief medical officer, Dr. Mahan Mohsen. Mahan, please go ahead.