Medicenna Reports First Quarter Fiscal 2021 Financial Results and Operational Highlights
- Further advances in recurrent glioblastoma program including submission of End of Phase 2 (“EOP2”) meeting package for MDNA55
- EOP2 meeting scheduled for 29th September, 2020 with FDA input expected in calendar Q4 2020
- Presented new preclinical data demonstrating the favorable safety profile and best-in-class potential of MDNA11 at ASCO 2020
- Depository Trust Certification (“DTC”) approved in July 2020
TORONTO and HOUSTON, Aug. 04, 2020 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA; OTCQB: MDNAF), a clinical stage immuno-oncology company, today announced its financial results and operational highlights for the quarter ended June 30, 2020. All dollar amounts are expressed in Canadian currency unless otherwise noted.
“I am very pleased with the progress made last quarter, as we were able to execute on planned clinical, scientific, and corporate milestones despite the unprecedented and industry wide challenges posed by COVID-19,” said Dr. Fahar Merchant, President and CEO of Medicenna. “Our MDNA11 IL-2 super-agonist continues to advance rapidly towards the clinic, with compelling preclinical safety, efficacy, and pharmacodynamic data presented at the 2020 American Society of Clinical Oncology (“ASCO”) meeting. We look forward to the continued development of this program, which will be facilitated by the recent $40 million financing. Notably, our fiscal first quarter also saw the advancement of our recurrent glioblastoma (“rGBM”) program toward the next stage of development, with new data and analyses from our completed Phase 2b trial presented at ASCO demonstrating MDNA55’s potential to change the treatment paradigm in this high need indication.”
Dr. Merchant continued, “Looking forward, our accomplishments last quarter have left us well positioned for the continued achievement of value creating milestones throughout the remainder of the calendar year. We expect such milestones to include a productive EOP2 meeting with the FDA regarding MDNA55 as well as the initiation of IND-enabling studies for MDNA11 this quarter. Importantly, these expected regulatory advances, combined with our intended listing on Nasdaq this year, will facilitate the continued near- and long-term growth of Medicenna through calendar year 2020 and beyond.”
Program highlights for the quarter ended June 30, 2020, along with recent developments, include:
MDNA55: Recurrent Glioblastoma Program:
MDNA11: IL-2 Superkine Program
Medicenna will focus on achieving the following milestones in the upcoming quarters:
Medicenna’s intended listing on the Nasdaq is subject to Medicenna meeting the requirements and criteria to complete such listing, and there can no assurance that such requirements and criteria will be satisfied.
Net loss for the quarter ended June 30, 2020 was $2,351,665, or $0.05 per share, compared to a loss of $1,294,634, or $0.05 per share, for the quarter ended June 30, 2019. The increase in net loss for the quarter ended June 30, 2020 compared with the quarter ended June 30, 2019 was primarily a result of no reimbursement under the CPRIT grant in the current year period compared with a reimbursement of $994,648 in the prior year period.
Research and development expenses of $1,813,105 were incurred during the year ended June 30, 2020, compared with $828,442 incurred in the year ended June 30, 2019. The increase in expenses in the current quarter is primarily attributable to no reimbursement under the CPRIT grant related to research and development expenses in the current year period compared with a reimbursement of $869,276 in the prior year period.
General and administrative expenses of $732,085 were incurred during the quarter ended June 30, 2020, compared with $461,539 during the quarter ended June 30, 2019. This increase in expenditures is primarily attributed to no reimbursement from CPRIT in the current year period as well as higher legal expenses in the current year period due to corporate initiatives.
Medicenna had cash, cash equivalents and marketable securities of $40,631,008 at June 30, 2020. These funds provide the Company with sufficient capital to late 2022 based on its current plans and projections.
This news release contains forward-looking statements under applicable securities laws. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects", "believes" and similar expressions. All statements other than statements of historical fact, included in this release, including, without limitation, that our MDNA11 IL-2 super-agonist continues to advance rapidly towards the clinic, that our accomplishments last quarter have left us well positioned for the continued achievement of value creating milestones throughout the remainder of the calendar year, that the End of Phase 2 meeting with the FDA regarding MDNA55 will be productive and will be held on September 29, 2020, that we will initiate IND-enabling studies for MDNA11 in calendar Q3, our planned listing on Nasdaq later this year and other regulatory advances, will facilitate the continued near- and long-term growth of Medicenna through calendar year 2020 and beyond, the planned initiation of a Phase 1 clinical study for MDNA11 will occur in H1 of calendar 2021 and statements related to the future plans and objectives of the Company, are forward-looking statements that involve risks and uncertainties. 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. Important factors that could cause actual results to differ materially from the Company's expectations include the risks detailed in the annual information form of the Company dated May 14, 2020 and in other filings made by the Company with the applicable securities regulators from time to time.
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. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements only as expressly required by applicable securities laws.
Further Information For further information about the Company please contact: Elizabeth Williams, Chief Financial Officer, 416-648-5555, firstname.lastname@example.org Investor Contact For more investor information, please contact: Dan Ferry, Managing Director, LifeSci Advisors, 617-430-7576, email@example.com