Medicenna Therapeutics Corp.

Hello, and welcome to the Medicina 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.

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 December 31, 2022. If you have not seen the press release, it is available on the investor page of Medicina's website. Before we begin, I would look 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 profile of MDNA 11, preliminary clinical data, the clinical potential, and development of MDNA 55, partnering efforts, cash runway, The presentation of additional data and other milestones in patent protection 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 in future events could differ materially from those anticipated in such events. Important factors that may cause actual results to differ materially from the company's expectations include the risks detailed in the Annual Information Form and 20F, 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 United States securities law. Speaking on today's call will be Meta Center'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?

Thanks, Dan, and good morning, everyone. I'll begin by discussing the most recent news out of our Phase I to Ability Study of MDNA 11, our beta-only, long-acting IL-2 super agonist. Earlier this morning, we announced that the Phase I 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 MDNA 11 as a suitable tolerability profile in the end-stage cancer patients that have enrolled in the phase one 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 advisors. With regards to safety, we are pleased to say that MDNA 11 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 anti-cancer immune response had not yet plateaued. Collectively, these data suggest that we may be able to safely administer higher doses of MDNA11, which in turn could further enhance anti-cancer effects. To begin testing this hypothesis, cohort six's dosing regimen includes 30 60 and 90 micrograms per kilogram priming doses of MDNA 11, followed by a further step up to the fixed 120 micrograms per kilogram target dose I mentioned earlier. For comparison, participants in the fifth cohort received two 30 micrograms 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 dose of MDNA 11 has already led to tumor response as presented last quarter at the CITC annual meeting. The data presented at CITC showed tumor control in five of 14 or 36% of invaluable patients treated with MDNA 11 moral therapy. This included a confirmed partial response in a 49 metastatic pancreatic cancer patient treated at 60 micrograms per kilogram, demonstrating MDNA 11's single-agent potential in a notoriously difficult-to-treat cancer. We also observed encouraging signs of MDNA 11's potential to drive durable clinical benefit as a patient achieving a partial response, so 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 anti-tumor 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 show dose-dependent and multifold increases in anti-cancer 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, Prolucan. Presented alongside these PD data were results demonstrating MDNA11's tolerability at the study doses, as well as PK data that showed dose-dependent increases in exposure that remained 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 CITC 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 supercrine 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 while avoiding the PK and safety shortcomings that plague Prolucan. 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 anti-tumor 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 II 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 supercrime. Therefore, rather than enrolling patients with a dozen or more disparate tumor types, which has been the case with the Phase I portion of the Ability Study, the Phase II 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 abilities phase two 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 MDNA 11'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 Ability6 and potentially the final dose escalation cohort, together with early antitumor activity data from the phase two 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 de-risk 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 bioblastoma, 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 predefined 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 non-proprietary name for MDNA55, which will now be referred to as Bizoxifib. Looking forward, we continue to pursue Bizoxifib's further development and potential commercialization through external partnership, as we have stated consistently in the past. will allow us to enable Bizaxa's advancement while maintaining our internal focus and resources on MDNA 11 in our BISCUITS program, which was the subject of a key patent issued earlier this year. This new issued patent extends protection into at least 20 with an IL-2 superclin in combination with checkpoint inhibitors, such as an NTPD-1 inhibitor, which is being advanced in the combination arm of the ABILITY study, and for biscuits, such as MDNA-223, which comprises an IL-2 supercrine linked to an NTPD-1 antibody. With checkpoint inhibitor patterns due to start expiring in 2028, we believe the data from ABILITY's combination study as well as MDNA 223's IP, could be an important tool to facilitate collaborations or partnership with leaders in this space. And with that, I'd have Liz review our fiscal third quarter financial results. Liz?