TORONTO and HOUSTON, TX, Nov. 13,
2017 /CNW/ - 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.
Medicenna
Therapeutics Corp.
|
|
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Condensed
Consolidated Interim Statements of Operations
|
|
(Expressed in
Canadian Dollars)
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
3 months ended
September 30,
2017
|
3 months ended
September 30,
2016
|
6 months ended
September 30,
2017
|
6 months ended
September 30,
2016
|
|
|
$
|
$
|
$
|
$
|
Operating
expenses
|
|
|
|
|
|
General and
administration
|
632,132
|
311,529
|
1,070,223
|
519,643
|
|
Research and
development
|
1,069,648
|
521,587
|
2,874,438
|
586,588
|
|
|
|
|
|
|
Total operating
expenses
|
1,701,780
|
833,116
|
3,944,661
|
1,106,231
|
|
Interest
income
|
443
|
4,164
|
2,743
|
5,551
|
|
Foreign exchange
(loss) gain
|
(16,915)
|
(115,702)
|
(32,006)
|
4,124
|
|
|
(16,472)
|
(111,538)
|
(29,263)
|
9,675
|
Net loss for the
period
|
(1,718,252)
|
(944,654)
|
(3,973,924)
|
(1,096,556)
|
Cumulative
translation adjustment
|
(79,648)
|
19,100
|
(124,579)
|
19,100
|
Net loss and
comprehensive loss for the
period
|
(1,797,900)
|
(925,554)
|
(4,098,503)
|
(1,077,456)
|
Basic and diluted
loss per share
|
(0.07)
|
(0.06)
|
(0.16)
|
(0.07)
|
Weighted average
number of
common shares outstanding
|
24,344,048
|
16,249,999
|
24,329,111
|
16,249,999
|
|
|
|
|
|
|
|
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.