TORONTO and HOUSTON, Feb. 13,
2020 /PRNewswire/ - 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, 2019. The Company's fiscal Q3 2020
interim financial statements and MD&A will be available on
SEDAR.
"We have achieved a number of exciting and important milestones
this quarter, both in the ongoing development of MDNA55 and MDNA19
and in further strengthening our financial position as we swiftly
advance towards the important End of Phase 2 meeting with the FDA
this spring," said Dr. Fahar
Merchant, President and CEO, Medicenna Therapeutics. "We've
documented exceptional survival advantage rates with MDNA55 in
patients with the most difficult to treat form of brain cancer when
compared to today's commonly used treatments, and will have key
non-human primate data for MDNA19 this quarter as we accelerate
development of our second important asset. Recent acquisitions in
the space are further evidence that Medicenna is ideally positioned
in a market that is growing in both opportunity and value, as major
pharmaceutical companies recognize the necessity of novel IL2
assets like MDNA19 to support their cancer portfolio."
The following are the achievements and highlights for the
quarter ending December 31, 2019,
through to the date hereof:
- On January 13, 2020, Medicenna
announced results from a retrospective study of subjects with
recurrent glioblastoma ("rGBM") receiving standard therapies who
matched eligibility requirements of subjects enrolled in the
MDNA55-05 clinical trial (Synthetic Control Arm, or SCA), and
compared their survival versus subjects treated with MDNA55 in the
Phase 2b rGBM clinical trial. The SCA
comprised of 81 rGBM patients receiving standard therapies,
including Avastin, Lomustine and Temozolomide, with similar
baseline features as patients treated in the MDNA55 trial
(including age, tumor size, ineligibility for surgery, lack of IDH
mutations, IL4R expression and other parameters known to affect
survival). A 150% survival advantage was seen in patients who
received MDNA55, when comparing IL4R High groups across the two
populations.
- On January 8, 2020, Medicenna
announced receipt of $1.3 million in
proceeds from the exercise of previously issued warrants. Of this
amount, $985,443 was received as of
December 31, 2019.
- On December 12, 2019, Medicenna
President and CEO Dr. Fahar Merchant
presented subgroup analysis data from the first 40 patients treated
with MDNA55 in a Phase 2b clinical
trial for patients with rGBM at the Inaugural Glioblastoma Drug
Development Annual Summit.
- On November 25, 2019, Medicenna
announced the presentation of updated clinical results from its
Phase 2b trial of MDNA55 at the
24th Society for Neuro-Oncology ("SNO") annual meeting.
The presentation was delivered by Dr. John
Sampson and discussed updated efficacy results from the
Phase 2b clinical trial of MDNA55 in
rGBM patients using the IL4R as an immunotherapy target.
- On November 21, 2019, Medicenna
announced positive new results on drug distribution from the
completed Phase 2b clinical trial of
MDNA55. The results showed that implementing new advances in
Convection Enhanced Delivery ("CED") allows the drug to bypass the
blood-brain barrier and deliver high concentrations of MDNA55
directly to the tumor and the at-risk area immediately surrounding
it, without exposure to the rest of the body. This approach, along
with the ability to continuously monitor distribution using
real-time imaging allows Medicenna to dramatically improve drug
delivery and maximize tumor coverage.
- On October 17, 2019, Medicenna
completed an oversubscribed public offering raising total gross
proceeds of $6,900,000. The Company
issued 5,307,693 units at $1.30,
consisting of one common share and one-half common share purchase
warrant. Each whole warrant is exercisable at $1.75 until October 17,
2022.
Financial Results
Medicenna had a cash balance of $6,974,004 at December 31,
2019 and subsequent to the quarter end has received
$856,100 in proceeds from warrant
exercises. The funds available are sufficient to complete the
MDNA55 Phase 2b clinical study and
planned End of Phase 2 meeting with the US FDA, continue the
development of MDNA19 and finance operations through 2020. In
addition, Medicenna has access to another US$1.4 million from the CPRIT grant.
For the three months ended December 31,
2019, Medicenna reported a net loss of $2,389,463 or $0.07
per share compared to a loss of $1,723,081 or $0.07
per share for the three months ended December 31, 2018. The increase in net loss
in the current year period was primarily a result of a lower amount
of costs reimbursed under the CPRIT grant in the current year
period ($nil) compared with the prior year period ($1,033,072).
The press release, the financial statements and the management's
discussion and analysis for the quarter ended December 31,
2019 will be available on SEDAR at www.sedar.com
About Medicenna Therapeutics Corp.
Medicenna is a clinical stage immunotherapy company focused on
oncology and the development and commercialization of novel, highly
selective versions of IL-2, IL-4 and IL-13 Superkines and first in
class Empowered Cytokines™ (ECs) for the treatment of a broad range
of cancers. Supported by a US$14.1M
non-dilutive grant from CPRIT (Cancer Prevention and Research
Institute of Texas), Medicenna's
lead IL4-EC, MDNA55, has completed enrolling patients in a Phase
2b clinical trial for rGBM, the most
common and uniformly fatal form of brain cancer, at top-ranked
brain cancer centres in the US. MDNA55 has been studied in five
clinical trials involving 132 patients, including 112 adults with
rGBM. MDNA55 has demonstrated compelling efficacy and has obtained
Fast-Track and Orphan Drug status from the FDA and FDA/EMA
respectively. 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, that
we have achieved a number of exciting and important milestones this
quarter, that the End of Phase 2 meeting with the FDA will be this
spring, that we will have key primate data for MDNA19 this quarter
that recent acquisitions in the space are further evidence that
Medicenna is ideally positioned in a market that is
growing in both opportunity and value, that major pharmaceutical
companies recognize the necessity of novel IL2 assets like MDNA19
to support their cancer portfolio, that Medicenna has access to
another US$1.4 million from the CPRIT
grant, and statements related to the future plans 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 24, 2019 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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SOURCE Medicenna Therapeutics Corp.