Dr. Fahar Merchant reports

MEDICENNA REPORTS FISCAL YEAR 2023 FINANCIAL RESULTS AND OPERATIONAL HIGHLIGHTS

Medicenna Therapeutics Corp. has released its financial results and corporate highlights for the fiscal year ended March 31, 2023, and is discussing anticipated near-term corporate milestones.

"Over the past fiscal year, we have made substantial progress in demonstrating the best-in-class potential of MDNA11, as it has shown encouraging preliminary safety, PK/PD and efficacy data in heavily pretreated end-stage cancer patients," said Dr. Fahar Merchant, PhD, president and chief executive officer of Medicenna. "Achieving a durable partial response in an end-stage pancreatic cancer patient at this very early stage of the clinical trial, designed to primarily establish safety of MDNA11, is very encouraging indeed. We continue to collect results from the remaining patients in the high-dose cohorts, including at least one posttreament scan, complete the safety review and finalize the design of the phase 2 dose expansion study. This will enable us to share a comprehensive data set and next steps during calendar Q3 2023. We believe that MDNA11 has the potential to demonstrate its positive attributes by further bolstering its efficacy in patients with less advanced cancers receiving the optimal dose, while retaining its safety features, in the upcoming phase 2 expansion portion of the trial."

Based on Medicenna's current development plans, it is anticipated that the current cash on hand will be sufficient to finance operations past key milestones of the Ability study and through calendar Q3 2024.

Program highlights for the fiscal year ended March 31, 2023, along with recent developments, include the following.

MDNA11: IL-2 superkine program

In March, 2023, Medicenna provided its most recent update on the MDNA11 clinical development program. MDNA11 is a next-generation IL-2 therapy currently being studied in the phase 1/2 Ability (a beta-only IL-2 immunotherapy) clinical trial. In the monotherapy dose escalation portion of Ability, MDNA11 continued to demonstrate prolonged and persistent single-agent activity in heavily pretreated, end-stage cancer patients, with desirable safety and PK/PD data in the fifth dose cohort, allowing dose escalation to proceed to the sixth and final dose of 120 mug per kilogram every two weeks.

Clinical activity highlights include:

• A participant with fourth-line metastatic pancreatic ductal adenocarcinoma (PDAC) maintained a confirmed partial response (PR) for two target lesions and achieved complete regression of a non-target metastatic lesion;
• A participant with third-line metastatic melanoma maintained stable disease (SD) at week 70;
• A participant with third-line non-clear cell renal cell carcinoma showed a meaningful period of SD prior to disease progression at week 23.

In January, 2023, Medicenna strengthened its intellectual property protection for the MDNA11 and BiSKITs programs with the United States Patent and Trademark Office's issuance of U.S. patent No. 11,542,312, which covers methods of treating cancer with an IL-2 superkine and PD1/PDL1 or CTLA-4 checkpoint inhibitor, administered in combination or as a single-agent BiSKIT. The term of the patent extends into at least 2039 without accounting for any potential extensions.

In November, 2022, Medicenna presented clinical data from the phase 1/2 Ability study of MDNA11 at the Society for Immunotherapy of Cancer 37th annual meeting. The company's two poster presentations covered the PK/PD, safety and anti-tumour activity of MDNA11 at that time point.

In September, 2022, Medicenna announced a clinical collaboration with Merck to evaluate MDNA11 in combination with Keytruda (pembrolizumab) in the Ability trial.

Bizaxofusp (formerly MDNA55): empowered IL-4 superkine program

In January, 2023, top-line results from the single-arm phase 2b clinical trial of MDNA55 were published in the peer-reviewed journal, Neuro-Oncology. The study, in patients with recurrent unresectable glioblastoma, met its primary end point, allowing for alignment with U.S. Food and Drug Administration (FDA) on an innovative, open-label hybrid design for a potential pivotal trial.

Preclinical pipeline programs

In April, 2023, Medicenna presented preclinical data characterizing IL-13 superkines and next-generation superkines at the 2023 annual meeting of the American Association for Cancer Research. The preclinical data demonstrated that two IL-13 superkines, MDNA132 and MDNA213, exhibit highly selective binding to the IL-13 decoy receptor (IL-13Ralpha2) and, in a mouse model, selectively accumulate in the tumour microenvironment for several days. The presentation also characterized a series of next-generation IL-13 superkines.

In September, 2022, Medicenna presented preclinical data demonstrating anti-tumour activity of an anti-PD1-IL-2 BiSKIT and long-acting IL-4/IL-13 superantagonist at the 10th annual meeting of the International Cytokine & Interferon Society. The data demonstrated that single-agent anti-PD1-IL-2 BiSKIT showed superior efficacy compared with a combination of an anti-PD1 antibody with an IL-2 superkine in murine models of colon, skin and breast cancer; and IL-4/IL-13 superantagonist displayed monotherapy activity in multiple cancer models and synergy in combination with an IL-2 superkine.

Operational highlights

In February, 2023, Medicenna established an at-the-market offering facility with Oppenheimer & Co. Inc., whereby Medicenna may sell common shares with an aggregate offering price of up to $10-million (U.S.).

In August, 2022, Medicenna raised $20-million (U.S.) in a public offering. The proceeds are being used to finance pipeline advancement.

Expected upcoming milestones

Initial anti-tumour activity data from Ability's fifth and sixth dose escalation cohort expected in calendar Q3 2023.

Commencement of the Ability study's phase 2 single-agent dose expansion portion expected in calendar Q3 2023.

Clinical update from the Ability study's phase 2 single-agent portion expected in calendar Q4 2023.

Commencement of the Ability study's phase 2 combination portion (MDNA11 plus Keytruda) expected in calendar Q4 2023.

Annual financial results

As of March 31, 2023, cash and cash equivalents were $33.6-million, compared with $20.5-million on March 31, 2022. These funds are expected to provide the company with sufficient capital to execute its current planned expenditures through the key milestones of the Ability study and through calendar Q3 2024 based on its current plans and projections.

Net loss for the year ended March 31, 2023, was $10.0-million or 16 cents per share, compared with a loss of $22.6-million or 42 cents per share for the year ended March 31, 2022.

The decrease in net loss for the year ended March 31, 2023, was a result of decreased research and development expenditures related to the MDNA11 program, a foreign exchange gain of $1.6-million and a non-cash change in the fair value of the warrant derivative (gain) of $4.3-million further contributed to the reduction in net loss. These reductions were partially offset by a reimbursement of $1.8-million under the CPRIT grant in the year ended March 31, 2022, which reduced R&D expenditures in the year ended March 31, 2022.

Research and development expenses of $9.3-million were incurred during the year ended March 31, 2023, compared with $14.7-million incurred in the year ended March 31, 2022. The decrease in research and development expenses in the current fiscal year is primarily attributed to costs associated with the development of MDNA11 incurred in the year ended March 31, 2022, including GMP manufacturing and IND enabling studies for which no comparable expenses were incurred in the current year. The reduction in MDNA11 development expenses was partially offset by higher clinical costs in the current-year period.

General and administrative expenses of $7.0-million were incurred during the year ended March 31, 2023, compared with $7.8-million during the year ended March 31, 2022. The decrease in G&A expenses in the year ended March 31, 2023, primarily relates to a reduction in directors and officers liability insurance premiums.

Medicenna's financial statements for the year ended March 31, 2023, and the related management's discussion and analysis (MD&A) will be available on SEDAR and on EDGAR.

About Medicenna Therapeutics Corp.

Medicenna is a clinical-stage immunotherapy company focused on the development of novel, highly selective versions of IL-2, IL-4 and IL-13 superkines, and first-in-class empowered superkines. Medicenna's long-acting IL-2 superkine, MDNA11, is a next-generation IL-2 with superior CD122 (IL-2 receptor beta) binding without CD25 (IL-2 receptor alpha) affinity, thereby preferentially stimulating cancer killing effector T cells and NK cells. Medicenna's early-stage BiSKITs program (bifunctional superkine immunotherapies) is designed to enhance the ability of superkines to treat immunologically cold tumours. Medicenna's IL-4 empowered superkine, bizaxofusp (formerly MDNA55), has been studied in five clinical trials, including a phase 2b trial for recurrent GBM, the most common and uniformly fatal form of brain cancer. Bizaxofusp has obtained fast-track and orphan drug status from the FDA and FDA/EMA, respectively.

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