TORONTO and HOUSTON, Nov. 5,
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 six months ended September 30, 2019. The Company's fiscal Q2 2020
interim financial statements and MD&A will be available on
SEDAR.
"This quarter has been an exceptionally productive period for
Medicenna as we significantly advance MDNA55 as an innovative
treatment paradigm for patients with end-stage recurrent
glioblastoma (rGBM). This has been validated by a recent
oversubscribed financing providing strong testament by investors
that we have widespread market support to build further value with
each of our programs," said Dr. Fahar
Merchant, President and Chief Executive Officer, Medicenna
Therapeutics. "We have the requisite financial resources leading
into several key near-term milestones, including additional data
from the MDNA55 Phase 2b clinical
trial followed by an End of Phase 2 meeting with the US FDA in
early 2020 and advancing MDNA19 towards the clinic."
The following are the achievements and highlights for the
quarter ending September 30, 2019, through to the date
hereof:
- On October 17, 2019, subsequent
to the quarter-end, the Company completed a 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.
- On September 30, 2019, Medicenna
announced the presentation of new pre-clinical data from its IL-2
Superkine program to support the differentiating in vitro
and in vivo characteristics of long-acting MDNA109 variants
relative to other IL-2 programs.
- On September 26, 2019 Medicenna
announced the publication of a peer-reviewed article in the
August 2019 edition of Nature
Communications providing independent third-party validation of
Medicenna's IL-2 Superkine platform, MDNA109.
- On September 25, 2019, Medicenna
presented updated efficacy results from the first 33 patients
enrolled in the Phase 2b clinical
trial (MDNA55-05). MDNA55 is a potent immunotherapy agent as it
potently targets the IL-4R which is overexpressed in GBM as well as
non-cancerous cells that make up the brain tumor microenvironment
("TME"). The data imply that targeting the TME, particularly in
GBM, is critical where almost half of the tumor mass is made up of
the TME - a cancer swamp that hides the tumor from the immune
system. The TME is emerging as one of the key reasons why
glioblastoma is extremely aggressive, and continues to be one of
the most difficult cancers to treat. Since MDNA55 can
simultaneously kill both the tumor cells and the TME by targeting
the IL-4R, the results to date indicate that MDNA55 could emerge as
a new treatment for this deadly disease.
- On September 24, 2019, Medicenna
announced the appointment of Ms. Karen
Dawes to its Board of Directors. Ms. Dawes is an experienced
and highly-regarded leader in the life sciences industry with
extensive strategic expertise and considerable commercial
background.
- On July 31, 2019, Medicenna
announced the selection of MDNA19 (formerly, MDNA109-LA1) as its
second immuno-oncology clinical candidate for the treatment of
cancer. MDNA19 is a best-in-class long-acting IL-2 developed from
Medicenna's Superkine platform that has shown unique ability to
selectively stimulate cancer killing immune cells without the
limitations seen with other long-acting IL-2 programs. Medicenna
expects to file an IND for MDNA19 in late 2020.
- On July 9, 2019 Medicenna
announced that it had received US$1,915,372 (approximately, CD$2.5M) in
non-dilutive funding from CPRIT.
Financial Results
Medicenna had a cash balance of $1,979,727 at September
30, 2019 and on October 17,
2019 completed a public offering raising gross proceeds of
$6,900,000. 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 September 30,
2019, Medicenna reported a net loss of $1,904,259 or $0.07
per share compared to a loss of $897,659 or $0.04
per share for the three months ended September 30, 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 compared with the prior year period.
The press release, the financial statements and the management's
discussion and analysis for the quarter ended September 30,
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 the current
quarter has been exceptionally productive, that MDNA55 has been
significantly advanced and that it is an innovative treatment
paradigm, that the oversubscribed financing provides strong
testament of widespread market support to build further value with
each program, that the Company has the requisite
financial resources leading in to several key near-term
milestones, that the End of Phase 2 meeting with the FDA
will occur in early 2020, 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.
SOURCE Medicenna Therapeutics Corp.