TORONTO and HOUSTON, TX, Feb. 12,
2018 /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 nine months ended December 31, 2017.
"We continue to make progress with respect to enrolment of the
MDNA55 Phase 2b clinical trial for
the treatment of recurrent glioblastoma (rGBM), the most common and
uniformly fatal form of brain cancer and expect to complete
enrolment in the first half of 2018." said Dr. Fahar Merchant, Chairman, President and CEO of
Medicenna. "We thank our investors for their continued support and
patience and look forward to providing an update on the trial
during the second quarter."
The following are the achievements and highlights for the
quarter ending December 31, 2017
through to the date hereof:
- The ongoing Phase 2b clinical
trial of MDNA55 for the treatment rGBM is currently enrolling
patients at nine clinical sites across the United States and one site in Europe. To date, 24 patients have been treated
in the trial and we expect to complete enrolment in the study by
mid-2018.
- On October 10, 2017, 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 October 18, 2017, our 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".
- In November, further drug distribution and safety data were
presented at the Annual Meeting of the Society for Neuro-Oncology
(San Francisco, CA), on the first
15 patients in the study confirming earlier results presented at
the Congress of Neurological Surgeons.
- Medicenna was issued a US Patent related to our 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 December 31,
2017, Medicenna reported a net loss of $2,181,022 or $0.09
per share compared to a loss of $2,178,966 or $0.13
per share for the three months ended December 31, 2016. For the nine months
ended December 31, 2017, Medicenna
reported a net loss of $6,154,946 or
$0.25 per share compared to a loss of
$3,275,522 or $0.20 per share for the nine months ended
December 31, 2016. The
increase in net loss in the three and nine months ended
December 31, 2017 compared with the
three and nine months ended December 31,
2016 is a result of increased 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 as well as the non-cash expenditures of stock based
compensation and research and development warrant amortization for
which no comparable expenses existed in the prior year.
Medicenna ended the quarter with a cash balance of $6,398,224. 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 $14.5 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 $1,351,703 were incurred during the three months
ended December 31, 2017, compared
with $1,597,982 incurred in the three
months ended December 31, 2016.
R&D expenses of $4,226,141
were incurred during the nine months ended December 31, 2017, compared with $2,184,570 incurred in the same period in the
prior year. On an overall basis R&D expense decreased in the
current three month period due to an offset of expenses eligible
for reimbursement from the Company's grant from the Cancer
Prevention and Research Institute of Texas ("CPRIT") of $1,884,820 compared with nil in the comparable
period in the prior year. Prior to the reimbursement, R&D
expenses increased in the three and nine month periods ended
December 31, 2017 compared with the
same periods in the prior year due to the initiation of early
discovery and pre-clinical activities associated with the Superkine
programs including MDNA109 and MDNA57, as well as clinical costs
associated with the ongoing Phase 2b
clinical trial of MDNA55. R&D expense was further
increased by non-cash expenditures related to the amortization of a
research and development warrant as well as stock based
compensation costs for which no comparable expenses existed in the
prior year. The above noted increases were partially offset
by expenses eligible for reimbursement from the Company's grant
from CPRIT of $3,334,424 for which
the Company was reimbursed in the nine months ended December 31, 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 $824,007 were incurred during the three months
ended December 31, 2017, compared
with $622,785 incurred during the
three months ended December 31, 2016.
G&A expenses of $1,894,230 were
incurred during the nine months ended December 31, 2017, compared with $1,142,428 incurred during the nine months ended
December 31, 2016. The
increase over the prior year periods is due to non-cash stock
option expenses, public company expenses associated with listing on
the TSX.V, increased listing fees related to both the TSX
graduation and the OTC listing and investor relations activities,
for which no comparable expenses existed in the prior year.
The above noted increases were partially offset by CPRIT eligible
expenses of $525,088 for which the
Company was reimbursed in the nine months ended December 31, 2017, compared with $403,490 in the same period in the prior
year.
Medicenna
Therapeutics Corp. Condensed Consolidated Interim Statements
of Operations
(Expressed in Canadian Dollars)
(Unaudited)
|
|
3 months ended
December 31,
2017
|
3 months ended
December 31,
2016
|
9 months ended
December 31,
2017
|
9 months ended
December 31,
2016
|
|
$
|
$
|
$
|
$
|
Operating
expenses
|
|
|
|
|
|
General and
administration
|
824,007
|
622,785
|
1,894,230
|
1,142,428
|
|
Research and
development
|
1,351,703
|
1,597,982
|
4,226,141
|
2,184,570
|
Total operating
expenses
|
2,175,710
|
2,220,767
|
6,120,371
|
3,326,998
|
|
Interest
income
|
376
|
6,427
|
3,119
|
11,978
|
|
Foreign exchange
(loss) gain
|
(5,688)
|
35,374
|
(37,694)
|
39,498
|
|
|
(5,312)
|
41,801
|
(34,575)
|
51,476
|
Net loss for the
period
|
(2,181,022)
|
(2,178,966)
|
(6,154,946)
|
(3,275,522)
|
Cumulative
translation adjustment
|
31,057
|
52,276
|
(93,522)
|
71,376
|
Net loss and
comprehensive loss for the period
|
(2,149,965)
|
(2,126,690)
|
(6,248,468)
|
(3,204,146)
|
Basic and diluted
loss per share
|
(0.09)
|
(0.13)
|
(0.25)
|
(0.20)
|
Weighted average
number of common shares outstanding
|
24,344,048
|
16,249,999
|
24,334,108
|
16,249,999
|
The press release, the financial statements and the management's
discussion and analysis for the quarter ended December 31,
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 rGBM at leading brain
cancer centres in the US. 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.
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 to complete
enrolment in the MDNA55 clinical trial in the first half of the
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.