Provides Update on Recurrent Glioblastoma Clinical Trial
TORONTO and HOUSTON, TX, Aug. 9, 2017 /CNW/ - Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA), a clinical stage immuno-oncology company, today reported financial results for the three months ended June 30, 2017.
"We are excited to announce that we have safely treated 10 patients in our Phase 2b clinical trial of MDNA55 for the treatment of recurrent glioblastoma, the most common and uniformly fatal form of brain cancer," said Dr. Fahar Merchant, Chairman, President and CEO of Medicenna. "We remain committed to complete the enrolment by the end of calendar 2017 as we expedite patient accrual at five new clinical sites. In addition to clinical progress this quarter we have graduated to the Toronto Stock Exchange and further strengthened our management team and patent portfolio making it a successful quarter for Medicenna in a transformational year."
The following are the achievements and highlights for the quarter ending June 30, 2017 through to the date hereof:
- In April 2017, announced treatment of the first patient in the Phase 2b clinical trial of MDNA55 for the treatment of recurrent glioblastoma, the most common and deadly form of brain cancer.
- Safely treated 10 patients in the recurrent glioblastoma clinical trial at 5 clinical sites in the United States. With 5 new sites planning to treat their first patient, the rate of patient enrolment is expected to increase and we anticipate that enrolment will be completed by the end of calendar 2017.
- On August 2, 2017, subsequent to the quarter end, Medicenna's common shares graduated to the Toronto Stock Exchange ("TSX"), the premier stock exchange in Canada.
- Appointed biotech industry veteran, Dr. Jay Stoudemire, as Chief Scientific Officer.
- Issued a US Patent related to Medicenna's lead clinical candidate MDNA55. U.S. Patent 9,629,899, issued to the U.S. Department of Health and Human Services and licensed exclusively to Medicenna, covers the combination of MDNA55 with other anti-cancer therapeutic agents.
Summary First Quarter of Fiscal 2018 Results
For the three months ended June 30, 2017, the Company reported a net loss of $2,255,672 or $0.09 per share compared to a loss of $151,902 or $0.01 per share for the three months ended June 30, 2016. The increase in net loss in the three months ended June 30, 2017 compared with the three months ended June 30, 2016 was primarily a result of increased spending on the Phase 2b clinical trial of MDNA55 for the treatment of recurrent glioblastoma including headcount necessary to support the ongoing trial, increased general corporate expenditures necessary to maintain a public company as well as a lower amount of expenditures claimed for reimbursement from CPRIT.
Research and development ("R&D") expenses of $1,804,790 were incurred during the three months ended June 30, 2017, compared with $65,001 in the three months ended June 30, 2016. The increase in R&D expenses in the three months ended June 30, 2017 compared with the same period in the prior year can be primarily attributed to the initiation of early discovery and pre-clinical activities associated with the Superkine program (MDNA109) as well as a research collaboration with MD Anderson Cancer Center with respect to the MDNA57 program. In addition, a research and development warrant was issued to consultants working with Medicenna on the development of our early stage programs. The warrant was issued January 1, 2017 and vests over an expected 24-month period. Clinical costs also increased significantly due to patient treatment and related costs in the Phase 2b clinical trial of MDNA55 for which the first patient was treated in April 2017. Moreover, salaries and benefits rose in the current quarter due to increased headcount to support the initiation and ongoing management of the Phase 2b clinical trial.
General and administrative ("G&A") expenses of $438,091 were incurred during the three months ended June 30, 2017, compared with $208,114 incurred during the three months ended June 30, 2016. The increase over the prior period is due primarily to stock based compensation expense in the current year which represents the fair value amortization of stock option grants issued to general and administrative employees and directors. The Company did not previously issue stock options during the same quarter in the prior year and therefore no comparable expense exists. In addition, there were increased legal and professional fees associated with investor relations activities, and other professional fees related to the TSX graduation application. Furthermore, other expenses increased due to additional travel requirements and filing fees associated with being a public company.
As at June 30, 2017 the Company had a cash balance of $12,031,892 and an additional US$6.5million available to drawn down under the Cancer Prevention and Research Institute of Texas grant.
The Company will focus on completing patient enrollment for its Phase 2b clinical trial for MDNA55, and expects interim top-line results in early 2018. Medicenna also plans to begin enrolling patients for a Phase 2 clinical trial of MDNA55 for the treatment of other types of brain cancer in the second half of 2017.
About Medicenna Therapeutics Corp.
Medicenna is a clinical stage immuno-oncology company developing novel highly selective versions of IL-2, IL-4 and IL-13 Superkines™ and first in class Empowered Cytokines™ (ECs). Its wholly owned subsidiary, Houston-based Medicenna BioPharma, is specifically targeting the Interleukin-4 Receptor (IL4R), which is over-expressed by at least 20 different types of cancer affecting more than one million new cancer patients every year. Medicenna's lead IL4-EC, MDNA55 is enrolling patients in a Phase 2b clinical trial for rGB at leading brain cancer centres in the US. MDNA55 has completed 3 clinical trials in 72 patients, including 66 adults with rGB, demonstrated compelling efficacy and obtained Fast-Track and Orphan Drug status from USFDA. Unlike most other cancer therapies, Medicenna's IL4-ECs have the potential to purge both the tumor and the immunosuppressive tumor microenvironment, offering a unique treatment paradigm for a large majority of cancer patients.
For more information, please visit www.medicenna.com.
This news release contains forward-looking statements relating to the future operations of the Company and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact, included in this release, including, without limitation, statements regarding future plans and objectives of the Company, the ability of the company to complete enrolment of the MDNA55 Phase 2b clinical trial by the end of the calendar year, the rate of patient accrual for the reminder of the study, the treatment of patients at additional clinical sites, the initiation of additional clinical studies in 2017, and others 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 June 15, 2017 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 Canadian securities law.
SOURCE Medicenna Therapeutics Corp.