Medicenna Therapeutics : Q3 Management's Discussion and Analysis
MDNA.TO
Management's Discussion and Analysis
For the Three and Nine Months Ended
December 31, 2024
DATE OF REPORT: February 12, 2025
MANAGEMENT'S DISCUSSION AND ANALYSIS
The following management's discussion and analysis ("MD&A") has been prepared as at February 12, 2025 for the three and nine months ended December 31, 2024 and should be read in conjunction with the unaudited interim condensed consolidated financial statements of Medicenna Therapeutics Corp. for the three and nine months ended December 31, 2024 and December 31, 2023, and the audited annual consolidated financial statements and accompanying notes for the year ended March 31, 2024 (the "Annual Financial Statements"), which have been prepared in accordance with International Financial Reporting Standards ("IFRS") as issued by the International Accounting Standards Board ("IASB"). Our IFRS accounting policies are set out in note 2 of the Annual Financial Statements and all dollar amounts are expressed in Canadian dollars unless otherwise noted.
All references in this MD&A to "the Company", "Medicenna", "we", "us", or "our" and similar expressions refer to Medicenna Therapeutics Corp. and the subsidiaries through which it conducts its business, unless otherwise indicated.
This MD&A contains forward-looking statements within the meaning of applicable securities laws. Forward- looking statements are neither historical facts nor assurances of future performance. Instead, they are based on current beliefs, expectations, or assumptions regarding the future of the business, future plans and strategies, operational results and other future conditions of the Company. These statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented. All statements contained herein other than statements of historical fact regarding the prospects of the Company's industry or its prospects, plans, financial position or business strategy may constitute forward- looking statements and can generally be identified by the use of forward-looking words, such as "seek", "plan", "expect", "is expected", "continue", "predict", "potential", "budget", "scheduled", "estimate", "forecast", "contemplate", "intend", "anticipate", or "believe" or variations (including negative variations) of such words and phrases, or statements that certain actions, events or results "may", "could", "would", "should", "might", "shall" or "will" be taken, occur or be achieved and similar expressions are generally intended to identify forward-looking statements.
By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other forward-looking statements will not be achieved. The Company cautions readers not to place undue reliance on these statements as a number of important factors could cause the actual results to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates and intentions expressed in such forward-looking statements. There can 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. Risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, as applicable, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information and statements include, but are not limited to, the risks described under the heading "Risks and Uncertainties" in this MD&A and the Company's Annual Information Form ("AIF") for the fiscal year ended March 31, 2024 filed on SEDAR+ on June 26, 2024.
Forward-looking statements in this MD&A include, but are not limited to:
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Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended, including the following:
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All forward-looking statements reflect the Company's beliefs and assumptions based on information available at the time the assumption was made. Although the forward-looking statements contained in this MD&A are based upon what the Company's management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements.
Any forward-looking statements represent the Company's estimates only as of the date of this MD&A and should not be relied upon as representing the Company's estimates as of any subsequent date. The Company undertakes no obligation to update any forward-looking statement or statements to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events, except as may be required by securities laws.
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COMPANY OVERVIEW
Medicenna Therapeutics is a clinical-stage immunotherapy company developing engineered cytokines, called Superkines, designed to improve the specificity, function and safety profile of unmodified interleukins. Medicenna's Superkine Platform transforms Superkines into multi-functional therapies that modulate, dampen, amplify or fine-tune the immune system.
Medicenna's mission is to harness the power of directed evolution to develop novel immunotherapies that have the potential to revolutionize the treatment landscape in oncology and other immune-related diseases.
Medicenna owns diverse platforms licensed from Stanford University ("Stanford") to develop a pipeline of Superkine candidates: IL-2 agonists, IL-2 antagonists and partial agonists of IL-2. Additional assets from Stanford also include several super-agonists of IL-4 and IL-13 and dual IL-4/IL-13 antagonists. These Superkines can be developed either on their own as short or long-acting therapeutics or fused with cell- killing proteins to generate Empowered Superkines that precisely deliver potent payloads to cancer cells without harming adjacent healthy cells. Superkines can also be fused with a large variety of proteins, antibodies, checkpoint inhibitors, and even other Superkines to incorporate two synergistic therapeutic activities into one molecule, creating novel Bi-specific SuperKine ImmunoTherapies and Targeted Metalloprotease Activated SuperKines, referred to by Medicenna as BiSKITsTM and T-MASKTM, respectively.
Medicenna's most advanced candidate is bizaxofusp, formerly MDNA55, a first-in-class IL-4 receptor ("IL- 4R") targeted therapy for the treatment of recurrent glioblastoma ("rGBM"), the most common and uniformly fatal form of brain cancer. Bizaxofusp is a fusion of a circularly permuted version of IL-4, fused to a potent fragment of the bacterial toxin, Pseudomonas exotoxin ("PE"), and is designed to preferentially target tumor cells that over-express the interleukin 4 receptor ("IL-4R"). Bizaxofusp has successfully completed a Phase 2b trial for rGBM and holds FastTrack and Orphan Drug status from the FDA and FDA/EMA, respectively.
Our second clinical program is MDNA11, a next-generation long-acting beta-enhanced not-alpha IL-2 super agonist. MDNA11 comprises a molecule of human albumin that accumulates in tumors and tumor draining lymph nodes and augments MDNA11's half-life. MDNA11 is currently being evaluated in the ABILITY-1 (A Beta-only IL-2 ImmunoTherapY) study, a Phase 1/2 clinical trial in patients with advanced and/or metastatic solid tumors. The ABILITY-1 study is a global, multi-center, open-label study that will assess the safety, tolerability and anti-tumor activity of MDNA11 as monotherapy and in combination with KEYTRUDA® (pembrolizumab) under a clinical collaboration with Merck. The Company has successfully completed a Phase 1 monotherapy dose-escalation study with MDNA11 with a favourable safety profile and demonstrated early signs of single-agent efficacy in this setting. The monotherapy recommended dose for expansion ("RDE") for MDNA11 has been established and enrollment in the dose-expansion phase 2 portion of the ABILITY-1 trial is currently underway. In addition, dose escalation study of MDNA11 in combination with KEYTRUDA® is currently in progress.
Our earlier stage candidates from the BiSKITsTM and T-MASKTM platforms, encompassing IL-2, IL-4 and IL- 13 super-agonists and super-antagonists, are in pre-clinical development.
RECENT ACHIEVEMENTS & HIGHLIGHTS
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weeks when treated with MDNA11 in combination with KEYTRUDA® (pembrolizumab). See Research
10) objective response rate ("ORR") in the monotherapy dose expansion cohort (in checkpoint-resistant patients). See Research & Development Update - MDNA11 for clinical updates.
FINANCING UPDATE
Nine months ended December 31, 2024
Private Placement
On April 26, 2024, the Company announced a $20 million investment by RA Capital Management ("RA"), a multi-stage investment manager based in Boston, MA, by way of a non-brokered private placement (the "2024 Offering"). The 2024 Offering closed on April 30, 2024. Pursuant to the terms of the 2024 Offering, RA subscribed for 5,141,388 Common Shares at a price of $1.95 per share and, in lieu of common shares, pre-funded warrants to purchase 5,141,388 Common Shares at a purchase price of $1.94 per pre-funded warrant, for total net proceeds to the Company of $20 million. The Company intends to use the net proceeds
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from the 2024 Offering for further development of its MDNA11 program, advancement of its preclinical programs and general corporate purposes.
Warrants
During the nine months ended December 31, 2024, there were 2,495,917 warrants exercised for proceeds of $3.8 million and 156,135 warrants that expired unexercised.
Nine months ended December 31, 2023
2023 At-The-Market Facility
On February 17, 2023, the Company entered into a sales agreement with Oppenheimer & Co. Inc., acting as sales agent (the "2023 ATM Agreement"), pursuant to which the Company may, from time to time sell, through at-the-market offerings on the Nasdaq such number of Common Shares as would have an aggregate offering price of up to US$10.0 million (the "2023 ATM Facility"). During the nine months ended December 31, 2023, the Company did not issue any Common Shares pursuant to the 2023 ATM Facility. As a result of the Nasdaq delisting, the 2023 ATM Agreement was terminated.
Warrants
During the nine months ended December 31, 2023, no warrants were exercised.
On July 5, 2023, the warrants issued on October 17, 2019, in correlation with a public offering, were due to expire on July 17, 2023 and were extended to October 17, 2024.
On December 18, 2023, the warrants issued on December 21, 2018 were due to expire on December 21, 2023 and were extended to July 31, 2024.
RESEARCH & DEVELOPMENT UPDATE
Our Pipeline of Superkines
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MDNA11
MDNA11 is the only long-acting 'beta-enhanced not-alpha' interleukin 2 ("IL-2") super agonist in clinical development, designed to preferentially activate anti-cancer immune cells (CD8+ T and NK cells) over immunosuppressive (pro-cancer) Tregs. Fusion with human albumin augments MDNA11's half-life and promotes its accumulation in tumors and tumor draining lymph-nodes. MDNA11 is currently being evaluatedin the Phase 1/2 ABILITY-1Study (NCT05086692) in patients with various advanced solid cancers. The ABILITY-1 Study is a global, multi-center, open-label clinical trial that assesses the safety, tolerability, and anti-tumor activity of MDNA11 as monotherapy and in combination with Merck's KEYTRUDA®. The figurebelow describes the ABILITY-1Study.
ABILITY-1 Study Schema: MDNA11 Monotherapy and in Combination with KEYTRUDA®
Deep and Durable Anti-tumor Activity with Single-Agent MDNA11 in Checkpoint Inhibitor (CPI) Resistant Patients:
On December 5th, 2024, at the Immunotherapy Bridge conference held in Naples, Italy, Medicenna reported updated clinical results from the monotherapy portion of the trial demonstrating continued deep and durable responses from the ABILITY-1 study:
On November 9th, 2024, at the 39th Annual Meeting of the SITC, Medicenna reported positive, updated clinical results from the ongoing monotherapy expansion and combination escalation portions of the Phase 1/2 ABILITY-1 Study. Comprehensive clinical updates were also presented on April 9th, 2024 at the Annual Meeting of the AACR. Key monotherapy updates included:
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Favorable Safety Profile in MDNA11 Monotherapy:
MDNA11 demonstrated a favorable safety profile and was generally well tolerated across all dose levels. Key monotherapy safety updates included:
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Robust Pharmacodynamic Response Consistent with Anticipated MDNA11 Pharmacology
Pharmacodynamic data on effector immune cells support the mechanistic rationale for MDNA11's promising anti-tumor activity. Key pharmacodynamic data included:
Robust Expansion of Anti-Cancer Effector Immune Cells but Not Immune Suppressive Tregs
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Disclaimer
Medicenna Therapeutics Corp. published this content on February 25, 2025, and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on February 25, 2025 at 20:10:27.821.