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.
Outlook
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.