Medicenna Therapeutics Corp. (“Medicenna” or “the Company”)
(NASDAQ: MDNA TSX: MDNA), a clinical-stage immunotherapy company,
today announced financial results and corporate highlights for the
first quarter ended June 30, 2023, as well as anticipated near-term
corporate milestones.
“We are pleased with our start to fiscal 2024
and remain on track to share data readouts for cohorts five and six
in addition to updates in lower dose cohorts. We believe that the
clearance by the Safety Review Committee of the 120µg/Kg dose
administered every 2 weeks, continues to demonstrate the acceptable
tolerability profile of MDNA11. Accordingly, we expect to announce,
on August 9th, the Recommended Dose for Expansion, as well as the
indications we plan to pursue in the monotherapy expansion cohort
of the Phase 2 ABILITY study following data review by the
independent clinical and safety advisors of the Company,” commented
Fahar Merchant, Ph.D., President and CEO of Medicenna. “We are
encouraged by the safety profile of MDNA11 to date in addition to
the prolonged and persistent single-agent activity in heavily
pre-treated, end-stage cancer patients, even though the purpose of
the Phase 1 ABILITY study was to evaluate the safety of MDNA11. We
look forward to evaluating MDNA11 in a Phase 2 patient population
in which the patients are less heavily treated in clinically
relevant tumor types and may therefore be more likely to respond to
immunotherapy treatments such as MDNA11.”
Operational Highlights
On April 17, 2023, we announced new preclinical
data characterizing the Interleukin 13 (IL-13) Superkines, MDNA132
and MDNA213 (an improved version of MDNA132), and a series of IL-13
BiSKITs, were presented at the AACR Annual Meeting, held in
Orlando, Florida. The results demonstrated that the IL-13
Superkines represent a versatile platform for engineering the next
generation of precision immunotherapies for many immune-resistant
IL-13Rα2 expressing tumors.
On April 25, 2023, the Company received an
extension notice (the “Extension Notice”) from Nasdaq granting the
Company’s request for a 180-day extension to regain compliance with
the Minimum Bid Requirement. The Company has until October 23, 2023
to regain compliance with the Minimum Bid Requirement. The
Extension Notice had no immediate effect on the listing or trading
of the Common Shares on Nasdaq, and the Company’s operations are
not affected by the receipt of the Extension Notice.
On July 20, 2023, Dr. Fahar Merchant, President
and CEO of Medicenna, was invited to present and participate in a
Research Roundtable organized by the National Brain Tumor Society.
The event, entitled, Use of External Control Data in Brain Tumor
Clinical Trials was held in Washington, D.C.
Expected Upcoming Milestones
Initial anti-tumor activity data from ABILITY’s fifth and sixth
dose escalation cohorts in calendar Q3 2023.
Commencement of the ABILITY study’s MDNA11 Phase 2
monotherapy arm expected in calendar Q3 2023.
Clinical update from the ABILITY study’s MDNA11 Phase
2 monotherapy arm expected in calendar Q4 2023.
Commencement of the MDNA11 plus pembrolizumab combination arm of
the ABILITY study in calendar Q4 2023.
Financial Results
As of June 30, 2023, cash, cash equivalents and
marketable securities were $29.6 million, compared to $33.6 million
on March 31, 2023.
Net loss for the quarter ended June 30, 2023,
was $2.9 million or $0.04 per share compared to a net loss of $4.2
million or $0.07 per share for the quarter ended June 30, 2022. The
decrease in net loss for the quarter ended June 30, 2023, compared
with the quarter ended June 30, 2022, was primarily a result of a
non-cash gain of $1.7 million related to the fair value of the
warrant derivative.
Research and development expenses of $2.8
million were incurred during the quarter ended June 30, 2023,
compared with $2.4 million incurred in the quarter ended June 30,
2022. The increase in R&D expenses in the current quarter was
primarily attributed to increased licensing and patent legal fees
and higher clinical costs associated with the MDNA11 ABILITY
Study.
General and administrative expenses of $1.6
million were incurred during the quarter ended June 30, 2023,
compared with $1.9 million during the quarter ended June 30, 2022.
The decrease in G&A expenses in the current quarter is
primarily a result of a reduction in directors and officers
liability insurance premiums.
About MedicennaMedicenna is a clinical stage
immunotherapy company focused on the development of novel, highly
selective versions of IL-2, IL-4 and IL-13 Superkines and first in
class Empowered Superkines. Medicenna’s long-acting IL-2 Superkine,
MDNA11, is a next-generation IL-2 with superior CD122 (IL-2
receptor beta) binding without CD25 (IL-2 receptor alpha) affinity
thereby preferentially stimulating cancer killing effector T cells
and NK cells. Medicenna’s early-stage BiSKITs™ program,
(Bifunctional SuperKine ImmunoTherapies) is designed to enhance the
ability of Superkines to treat immunologically “cold” tumors.
Medicenna’s IL-4 Empowered Superkine, bizaxofusp (formerly MDNA55),
has been studied in 5 clinical trials including a Phase 2b trial
for recurrent GBM, the most common and uniformly fatal form of
brain cancer. Bizaxofusp has obtained FastTrack and Orphan Drug
status from the FDA and FDA/EMA, respectively.
Forward Looking StatementsThis news release
contains forward-looking statements within the meaning of
applicable securities laws that relate to the future operations of
the Company, plans and projections and other statements, including
statements on the development and potential of the Company’s IL-13
Superkines; the timing, progress and release of data from the
Company’s planned and ongoing clinical trials; and the sufficiency
of the Company’s current cash and cash equivalents to fund its
planned operations through the completion of the ABILITY study and
through calendar Q3 2024. Forward-looking statements are often
identified by terms such as “will”, “may”, “should”, “anticipate”,
“expect”, “believe”, “seek”, “potentially” and similar expressions.
and are subject to 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 latest Annual Information Form
and Annual Report on Form 20-F of the Company for year ended March
31, 2023 and in other filings made by the Company with the
applicable securities regulators from time to time
in Canada and the United States.
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, 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 hereof and except as
required by law, we do not intend and do not assume any obligation
to update or revise publicly any of the included forward-looking
statements.
Further Information
For further information about the Company, please contact:
Elizabeth Williams, Chief Financial Officer, 416-648-5555, ewilliams@medicenna.com
Media Contact
For media inquiries, please contact:
Tony Russo,Russo Partners, 212-845-4251,tony.russo@russopartnersllc.com
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