TORONTO and HOUSTON, TX, June 16, 2017 /CNW/ - Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSXV: MDNA), a clinical stage immuno-oncology company, today announced its operational and financial results for the year ended March 31, 2017.
"The past year has been transformational for Medicenna, achieving several clinical, corporate and financial milestones, with treatment of the first recurrent glioblastoma patient in our Phase 2b clinical trial of MDNA55 being the most significant," said Dr. Fahar Merchant, Chairman, President and CEO of Medicenna. "We extended our cash runway by successfully completing a series of private placements raising $14 million in capital, completed a reverse takeover, began trading on the TSXV and solidified our platform technology following the issuance of three additional patents. We have complemented these milestones by initiating activities related to our pre-clinical pipeline that we believe could generate substantial value to our shareholders for years to come. We look forward to the year ahead and top-line data from the MDNA55 Phase 2b clinical trial."
The following are the achievements and highlights for the year ending March 31, 2017 through to the date hereof:
- Initiated a Phase 2b clinical trial of MDNA55 for the treatment of recurrent glioblastoma (rGB), the most common and uniformly fatal form of brain cancer, and treated the first patient in April 2017. Medicenna expects to complete enrolment in the clinical study by the end of 2017;
- Completed a reverse takeover transaction (the "Transaction") resulting in its shares trading on the TSX Venture Exchange (TSXV) under the symbol "MDNA" in March 2017;
- Raised $14 million through a series of private placement financings and received an advance of USD $5 million in February 2017 of the USD $14.1 million in non‐dilutive funds awarded by the Cancer Prevention and Research Institute of Texas ("CPRIT");
- Strengthened its patent portfolio with the issuance of two U.S. patents related to the Company's Superkine™ platform, and a patent covering the combination of MDNA55 with other anti-cancer therapeutic agents;
- Entered into a multi-year sponsored research agreement with MD Anderson Cancer Center ("MDACC") to pursue development of next-generation fully human IL4-Empowered Cytokines ("MDNA57") for the treatment non-CNS cancers;
- Strengthened its management team by appointing Dr. Martin Bexon as Head of Clinical Development, Elizabeth Williams as Chief Financial Officer, and Patrick Ward as Chief Operating Officer; and
- Added expertise to its Board of Directors by appointing Mr. Albert Beraldo, Mr. Andrew Strong, and Dr. Chandra Panchal as non-executive independent directors.
Annual Financial Results
Net loss for the year ended March 31, 2017 was $7,631,265, compared to a net loss of $1,334,064 for the year ended March 31, 2016. The increase in net loss in the year ended March 31, 2017 compared with the year ended March 31, 2016 was primarily a result of a one-time non-cash listing expense of $1,784,414 related to the Transaction, costs associated with initiating the Phase 2b clinical trial of MDNA55 (including headcount necessary to support the ongoing trial), intellectual property costs (including a one-time license payment of $636,000 related to the Transaction), professional fees related to the Transaction and increased general corporate expenditures necessary to establish and operate a public company.
Research and development expenses for the year ended March 31, 2017 were $4,229,110, compared to $771,408 for the year ended March 31, 2016. The increase is primarily due to costs associated with the initiation of the Phase 2b clinical trial of MDNA55 - including purchase of clinical supplies such as drug delivery software and catheters - regulatory filing costs, outsourcing of trial related activities to clinical research organizations and site initiation costs. In addition, a one-time license fee payment of $636,000 became due upon completion of the Transaction and is payable in equal instalments over four years. Salaries and benefits also rose in the current year due to increased headcount to support the initiation and ongoing management of the Phase 2b clinical trial. Discovery and pre-clinical activities increased due to initiation of the IL-2 Superkine (MDNA109) and MDNA57 programs, the latter of which is being developed in collaboration with MDACC.
General and administrative expenses for the year ended March 31, 2017 were $1,684,611, compared to $428,256 for the year ended March 31, 2016. The increase is primarily due to professional fees associated with the private placement and subscription receipt financings, investor relations activities as well as legal fees related to the Transaction. Salaries and benefits also increased due to additional personnel needed to support ongoing activities and the establishment and operation of a public company.
Quarterly Financial Results
Net loss for the three months ended March 31, 2017 was $4,355,743 compared to a net loss of $197,732 for the three months ended March 31, 2016. The increase is primarily the result of clinical trial costs associated with enrollment and development initiatives as well as site costs related to the initiation of the Phase 2b clinical trial of MDNA55. 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. The amount recorded in the year ended March 31, 2017 relates to the fair value expense for the three-month period following issuance. A one-time non-cash expense related to the Transaction of $1,784,414 was also incurred in the three months ended March 31, 2017, resulting from the Transaction. Expenses related to the Transaction as well as a one-time license fee of $636,000 were also incurred during this period.
Research and development expenses for the three months ended March 31, 2017 were $2,044,540 compared to ($162,654) in the three month period ended March 31, 2016. The increase in research and development expenditures for the three months ended March 31, 2017 were due to the initiation of the Phase 2b clinical trial of MDNA55, the MDACC collaboration and a one-time license fee discussed above. The credit balance in the three-months ended March 31, 2016 was attributable to a refund of previously incurred expenses from CPRIT.
General and administrative expenses for the three months ended March 31, 2017 were $542,243 compared to $226,535 in the three months ended March 31, 2016. The increase over the prior year is due to an increase in legal and other professional fees related to the Transaction and stock option expenses in the current year period, which represent the fair value amortization of stock option grants issued in February 2017 to general and administrative employees and directors. Furthermore, facilities and operations expenses increased due to the maintenance of an office space in Houston to support ongoing operations in Texas.
The Company will focus on completing patient enrollment for its Phase 2b clinical trial for MDNA55, and expects 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 metastatic brain cancer in the second half of 2017.
At March 31, 2017, the Company had $14,038,115 in cash and an additional US $6.5 million available under the CPRIT grant.
Stock Option Grant
On June 15, 2017, Medicenna issued 125,000 stock options to an Officer of the Company. The options have an exercise price of $2.40 per share and a ten year life. The options vest over a three year period.
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.
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 ability of the company to attract institutional interest, the success of MDNA55 in past or future clinical trials 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.