TORONTO and HOUSTON, TX, Feb. 14,
2019 /CNW/ - Medicenna Therapeutics Corp. ("Medicenna"
or the "Company") (TSX: MDNA; OTCQB: MDNAF), a clinical stage
immuno-oncology company, today reported financial results for the
three and nine months ended December 31,
2018.
The following are the achievements and highlights for the
quarter ending December 31, 2018
through to the date hereof:
- Presented promising survival data from the ongoing MDNA55 Phase
2b clinical trial for the treatment
of recurrent glioblastoma ("rGBM") the most common and uniformly
fatal form of brain cancer showing a median overall survival of
15.2 months in the IL4 receptor positive patients who have a more
aggressive form of rGBM. Whereas the current standard of care for
all rGBM patients provide a median overall survival of only 8.0
months.
- Strengthened the balance sheet with a $4.0 million financing in December 2018 and received an additional
US$1.2 million in non-dilutive
funding in the same month.
- Provided an update on MDNA109 demonstrating that it has
best-in-class potency toward cancer killing effector T cell and
that it potently synergizes with anti-PD-1 or anti-CTLA-4
checkpoint inhibitors to eliminate tumors in the majority of
tumor-bearing mice.
Upcoming milestones include:
- Completion of patient enrolment in the MDNA55 Phase
2b rGBM is anticipated by the end of
Q1 2019
- Top line interim results announced in the MDNA55 Phase
2b clinical trial mid-2019
- Initiation of Phase 2 clinical trial with MDNA55 for the
treatment of newly diagnosed GBM in Q2 2019
- Selection of lead MDNA109 candidate in Q1 2019
"2019 is off to an excellent start with compelling median
overall survival data in the MDNA55 Phase 2b clinical trial for the treatment of recurrent
glioblastoma reported in February as well as the impressive
pre-clinical package we are assembling for MDNA109," said Dr.
Fahar Merchant, President and CEO of
Medicenna. He added that "the clinical and scientific progress we
have made in addition to the capital raised and non-dilutive funds
received in December has placed Medicenna on an excellent footing
to hit key value inflection milestones for 2019."
MDNA55 update
On February 7,
2019 Dr. John H. Sampson, MD,
PhD, (Robert H. and Gloria Wilkins Distinguished Professor and
Chair of Neurosurgery at Duke
University in Durham, NC)
presented new clinical study results on MDNA55 for the treatment of
rGBM at the 5th Annual Immuno-Oncology 360o
Conference held in New York, NY. In a podium presentation
entitled, "The IL4 Receptor as a Biomarker and Immunotherapeutic
Target for Glioblastoma: Preliminary Evidence with MDNA55, a
Locally Administered IL-4 Guided Toxin", Dr. Sampson outlined that
following a single treatment with MDNA55 at the low dose, (a) the
IL4R positive group showed a remarkable increase in median overall
survival ("mOS") of 15.2 months when compared to 8.5 months in the
IL4R negative group and (b) irrespective of IL4R expression, mOS
was 11.8 months in all patients, substantially exceeding landmark
mOS reported for approved drugs for rGBM (mOS is 8 months for
Avastin and Lomustine).
On October 22, 2018, the Company
presented results and participated in a poster discussion session
at the European Society for Medical Oncology Congress held in
Munich on October 20, 2018. Based on interim data from
patients treated at low doses implemented during the first half of
the Phase 2b study of MDNA55, the
presentation highlighted the benefits of using of advanced imaging
modalities in order to help tumor response evaluation and identify
pseudo-progression in some patients which ultimately translates
into tumor shrinkage, and potential treatment benefit.
On November 16, 2018, Medicenna
presented an update on intratumoral delivery of MDNA55 using
MRI-guided convective delivery at the 23rd Annual Meeting of the
Society for Neuro-Oncology
MDNA109 update
On February 6,
2019 Dr. Moutih Rafei, PhD, (Associate Professor, Department
of Pharmacology and Physiology, Université de Montreal) presented new results on MDNA109 and
its long acting variants at the 5th Annual
Immuno-Oncology 360o Meeting held in New York, NY. In a podium presentation
entitled, "Putting Pedal to the Metal: Combining IL-2 Superkine
(MDNA109) with Checkpoint Inhibitors." The presentation outlined
that MDNA109, an engineered IL-2 superkine exhibited a 1000-fold
enhanced affinity toward the CD122 receptor, has best-in-class
potency toward cancer killing effector T cells, was not immunogenic
in-vivo and potently synergized with anti-PD-1 or
anti-CTLA-4 checkpoint inhibitors to eliminate tumors in the
majority of tumor-bearing mice.
On November 9, 2018, Medicenna
presented an update on preliminary pre-clinical results on MDNA109
at the 33rd Annual Meeting of the Society for
Immunotherapy of Cancer held in Washington, DC.
Operational update
On December
21, 2018, the Company completed a public offering and issued
4,000,000 units of the Company for gross proceeds of CDN$4,000,000.
On December 5, 2018, Medicenna
received a US$1.2 million
reimbursement of past expenses from the Cancer Prevention and
Research Institute of Texas
("CPRIT").
Financial Results
For the three months ended
December 31, 2018, Medicenna reported
a net loss of $1,723,081 or
$0.07 per share compared to a loss of
$2,181,022 or $0.09 per share for the three months ended
December 31, 2017. For the nine
months ended December 31, 2018,
Medicenna reported a net loss of $3,658,957 or $0.15
per share compared to a loss of $6,154,946 or $0.25
per share for the nine months ended December
31, 2017.
Research and Development Expenses
Research and
development ("R&D") expenses of $2,356,683 were incurred during the nine months
ended December 31, 2018, compared
with $4,226,141 incurred in the nine
months ended December 31, 2017 and
were $1,275,896 during the three
months ended December 31, 2018,
compared with $1,351,703 incurred in
the three months ended December 31,
2017. The decrease in the expenses in the current year
periods can be primarily attributed to reduced discovery and
pre-clinical expenses due to work ongoing and completed in the
prior year related to the development of MDNA57as well as lower
clinical trial costs due to reduced consulting costs, clinical
supplies and CRO fees due to nearing the end of the clinical study
and general cost containment. Finally, the variance in
recoveries from CPRIT contributed to the changes in net loss of
$905,585 in the three months and
$3,824,293 in the nine months ended
December 31, 2018 compared with
$1,884,820 in the three months and
$3,334,424 in the nine months ended
December 31, 2017
General and Administrative Expenses
General and
administrative ("G&A") expenses of $437,218 were incurred in the three months and
$1,295,132 in the nine months ended
December 31, 2018, compared with
$824,007 in the three months and
$1,894,230 in the nine months ended
December 31, 2017. The decrease in
G&A expenses period over period is attributed primarily to
lower stock based compensation costs due to timing of grants as
well as a lower number of option grants in the current year
periods, reduced legal expenses in the current year periods due to
expenses related to the graduation from the TSXV to TSX as well as
the OTC listing incurred in the prior year periods and lower salary
and benefit costs due to headcount reductions and a bonus accrual
in the prior year and no comparable accrual in the current year
periods.
Selected Consolidated Financial Information:
Medicenna
Therapeutics Corp.
|
Condensed
Consolidated Interim Statement of Operations
(unaudited)
|
(Expressed in
Canadian Dollars)
|
|
|
|
|
|
|
3 months
ended
December 31,
2018
|
3 months
ended
December 31,
2017
|
9 months
ended
December 31,
2018
|
9 months
ended
December 31,
2017
|
|
$
|
$
|
$
|
$
|
Operating
expenses
|
|
|
|
|
General and
administration
|
437,218
|
824,007
|
1,295,132
|
1,894,230
|
Research and
development
|
1,275,896
|
1,351,703
|
2,356,683
|
4,226,141
|
Total operating
expenses
|
1,713,114
|
2,175,710
|
3,651,815
|
6,120,371
|
|
|
|
|
|
Interest
income
|
(1)
|
(376)
|
(102)
|
(3,119)
|
Foreign exchange
loss
|
9,968
|
5,688
|
7,244
|
37,694
|
|
9,967
|
5,312
|
7,142
|
34,575
|
Net loss for the
period
|
(1,723,081)
|
(2,181,022)
|
(3,658,957)
|
(6,154,946)
|
Basic and diluted
loss per share for the period
|
(0.07)
|
(0.09)
|
(0.15)
|
(0.25)
|
|
|
|
|
|
Weighted average
number of common
shares outstanding
|
25,012,920
|
24,344,048
|
24,723,592
|
24,334,108
|
|
|
|
|
|
|
|
|
|
|
|
|
The press release, the financial statements and the management's
discussion and analysis for the quarter ended December 31,
2018 will be available on SEDAR
at www.sedar.com
About Medicenna
Medicenna is a clinical stage immunotherapy company developing
novel highly selective versions of IL-2, IL-4 and IL-13 Superkines
and first in class Empowered Cytokines™ (ECs). Our mission is to
become the leader in the development and commercialization of ECs
and Superkines for the treatment of a broad range of cancers and
immune-mediated diseases. MDNA55 is Medicenna's lead EC currently
enrolling in a multi-centre Phase 2 clinical trial for the
treatment of recurrent glioblastoma (rGBM), the most common and
uniformly fatal form of brain cancer. MDNA55 has secured Orphan
Drug Status from the United States Food and Drug Administration
(FDA) and the European Medicines Agency as well as Fast Track
Designation from the FDA for the treatment of rGBM. 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 with
respect to the ongoing development of MDNA55 and MDNA109, the
timelines associated with the MDNA55 clinical trials included
enrolment and top line interim results and objectives of the
Company, 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 26, 2018 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.
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content:http://www.prnewswire.com/news-releases/medicenna-reports-third-quarter-fiscal-2019-financial-results-300796329.html
SOURCE Medicenna Therapeutics Corp.