MDNA Medicenna Therapeutics Corp

TORONTO and HOUSTON, TX, Nov. 13, 2017 /PRNewswire/ - Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA; OTCQX: MDNAF), a clinical stage immuno-oncology company, today reported financial results for the three and six months ended September 30, 2017.

"We are pleased with the reassuring safety profile and promising drug distribution data we have seen with respect to the novel high flow delivery of MDNA55 in the first patients in the ongoing Phase 2b clinical trial for the treatment of recurrent glioblastoma (rGBM), the most common and uniformly fatal form of brain cancer.  We believe that with the amended protocol and increased dose, we are providing patients with an improved likelihood of success with a single treatment of MDNA55." said Dr. Fahar Merchant, Chairman, President and CEO of Medicenna. "While we continue to focus our efforts on completing enrolment in the study by Q1 2018 we have also made progress at the corporate front with graduation to the main board of the Toronto Stock Exchange and listing on the OTCQX in the United States which provides Medicenna enhanced market exposure and greater access to potential investors world-wide."

The following are the achievements and highlights for the quarter ending September 30, 2017 through to the date hereof:

• Following the unanimous recommendation from the MDNA55 clinical Safety Review Committee after enrollment of the first six patients, Medicenna has implemented an amended protocol that incorporates an enhanced drug delivery procedure which will be used for the treatment of the remaining patients. The updated protocol includes higher doses and volumes of MDNA55 as well as an increase in the total expected study size – from 43 patients under the original protocol to 52 total planned patients.
  
  
• The Phase 2b clinical trial of MDNA55 for the treatment rGBM is continuing to enroll patients at nine clinical sites across the United States and one site in Europe. To date 16 patients have been treated in the trial and we expect to complete enrolment in the study (52 patients) by the end of the first quarter of calendar 2018.
  
  
• On October 10, 2017, subsequent to the quarter end, new clinical data was presented at the 2017 Congress of Neurological Surgeons (Boston, MA), demonstrating successful delivery in brain cancer patients and a reassuring safety profile for MDNA55 as well as a substantially higher proportion of the target tissue being covered then in previous similar trials. In some cases, close to 100% of the tumor and the 1cm margin around it (at risk for tumor spread) had been successfully covered.
  
  
• On August 1, 2017 Medicenna announced the graduation of its common shares to the main board of the Toronto Stock Exchange ("TSX"), the premier stock exchange in Canada.
  
  
• On October 18, 2017, subsequent to the quarter end, Medicenna's common shares were listed on the OTCQX International ("OTCQX"), a segment of the OTC marketplace reserved for high-quality non-U.S. companies, under the symbol, "MDNAF".
  
  
• On September 21, 2017 the Company appointed Dr. William Li, an experienced oncology drug development expert, to the Board of Directors.
  
  
• Medicenna was issued a US Patent related to its Superkine platform. U.S. Patent 9,738,696, issued to the Board of Trustees of the Leland Stanford Junior University and licensed exclusively to Medicenna, covers the composition of engineered IL-4 Superkines.

Financial Results

For the three months ended September 30, 2017, Medicenna reported a net loss of $1,718,252 or $0.07 per share compared to a loss of $944,654 or $0.06 per share for the three months ended September 30, 2016.  For the six months ended September 30, 2017, Medicenna reported a net loss of $3,973,924 or $0.16 per share compared to a loss of $1,096,556 or $0.07 per share for the six months ended September 30, 2016.   The increase in net loss in the three and six months ended September 30, 2017 compared with the three and six months ended September 30, 2016 was primarily a result of spending on the Phase 2b clinical trial of MDNA55 including headcount necessary to support the ongoing trial, and increased general corporate expenditures necessary to operate a public company.

Medicenna ended the quarter with a cash balance of $9,535,093.  As well, Medicenna has access to an additional US$6.5 million under the Company's grant from the Cancer Prevention and Research Institute of Texas ("CPRIT") providing total available funding of approximately $17.5 million, which, based on information currently available and current expected cash burn, provides the Company with sufficient resources to fund research and development and operations into Q1 of calendar 2019.

Research and Development Expenses
Research and development ("R&D") expenses of $1,069,648 were incurred during the three months ended September 30, 2017, compared with $521,587 incurred in the three months ended September 30, 2016.  R&D expenses of $2,874,438 were incurred during the six months ended September 30, 2017, compared with $586,643 incurred in the same period in the prior year. The increase in R&D expenses in the three and six month periods ended September 30, 2017 compared with the same periods 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 development of the MDNA57 program.  In addition, a research and development warrant was issued to consultants working with Medicenna on the development of its 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.  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. The above noted increases were partially offset by expenses eligible for reimbursement from the Company's CPRIT grant of $1,449,604 for which the Company was reimbursed in the six months ended September 30, 2017, compared with $1,516,131 in the same period in the prior year.

General and Administrative Expenses
General and administrative ("G&A") expenses of $632,132 were incurred during the three months ended September 30, 2017, compared with $311,529 incurred during the three months ended September 30, 2016. G&A expenses of $1,070,223 were incurred during the six months ended September 30, 2017, compared with $519,643 incurred during the six months ended September 30, 2016.   The increase over the prior year periods is due to stock option expenses in the current year periods, for which no comparable expense existed in the prior year as well as increased professional fees associated with investor relations activities, and other professional fees related to the TSX graduation including listing fees and the OTCQX listing completed subsequent to the quarter end.  The above noted increases were partially offset by CPRIT eligible expenses of $345,415 for which the Company was reimbursed in the six months ended September 30, 2017, compared with $403,490 in the same period in the prior year.

The press release, the financial statements and the management's discussion and analysis for the quarter ended September 30, 2017 will be available on SEDAR at www.sedar.com 

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 and Europe. MDNA55 has completed 3 clinical trials in 72 patients, including 66 adults with rGBM, 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.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Exchange) accepts responsibility for the adequacy or accuracy of this press release. 

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 projected cash burn of the company, the ability to complete clinical trial enrolment by Q1 2018 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.