Medicenna Therapeutics Corp. (“Medicenna” or “the Company”)
(NASDAQ: MDNA TSX: MDNA), a clinical-stage immunotherapy company,
today reported financial results and corporate highlights for the
fiscal year ended March 31, 2023, as well as anticipated near-term
corporate milestones.
“Over the past fiscal year, we have made
substantial progress in demonstrating the best-in-class potential
of MDNA11, as it has shown encouraging preliminary safety, PK/PD
and efficacy data in heavily pre-treated end-stage cancer
patients,” said Fahar Merchant, Ph.D., President and CEO of
Medicenna. “Achieving a durable partial response in an end-stage
pancreatic cancer patient at this very early stage of the clinical
trial, designed to primarily establish safety of MDNA11, is very
encouraging indeed. We continue to collect results from the
remaining patients in the high dose cohorts, including at least one
post-treament scan, complete the safety review, and finalize the
design of the Phase 2 dose expansion study. This will enable us to
share a comprehensive data set and next steps during calendar Q3
2023. We believe that MDNA11 has the potential to demonstrate its
positive attributes by further bolstering its efficacy in patients
with less advanced cancers receiving the optimal dose, while
retaining its safety features, in the upcoming Phase 2 expansion
portion of the trial.”
Based on Medicenna’s current development plans,
it is anticipated that the current cash on hand will be sufficient
to fund operations past key milestones of the ABILITY study and
through calendar Q3 2024.
Program highlights for the fiscal year ended
March 31, 2023, along with recent developments, include:
MDNA11: IL-2 Superkine Program
In March 2023, Medicenna provided its most
recent update on the MDNA11 clinical development program. MDNA11 is
a next-generation IL-2 therapy currently being studied in the Phase
1/2 ABILITY (A Beta-only IL-2 ImmunoTherapY) clinical trial. In the
monotherapy dose escalation portion of ABILITY, MDNA11 continued to
demonstrate prolonged and persistent single-agent activity in
heavily pre-treated, end-stage cancer patients, with desirable
safety and PK/PD data in the fifth dose cohort, allowing dose
escalation to proceed to the sixth and final dose of 120μg/Kg every
2 weeks.
Clinical activity highlights include:
- A participant with fourth-line metastatic pancreatic ductal
adenocarcinoma (“PDAC”) maintained a confirmed partial response
(“PR”) for two target lesions and achieved complete regression of a
non-target metastatic lesion.
- A participant with third-line metastatic melanoma maintained
stable disease (“SD”) at week 70.
- A participant with third-line non-clear cell renal cell
carcinoma showed a meaningful period of SD prior to disease
progression at week 23.
In January 2023, Medicenna strengthened its
intellectual property protection for the MDNA11 and BiSKITs™
programs with the United States Patent and Trademark Office’s
issuance of U.S. Patent No. 11,542,312, which covers methods of
treating cancer with an IL-2 Superkine and PD1/PDL1 or CTLA-4
checkpoint inhibitor, administered in combination or as a single
agent BiSKIT™. The patent’s term extends into at least 2039 without
accounting for any potential extensions.
In November 2022, Medicenna presented clinical
data from the Phase 1/2 ABILITY study of MDNA11 at the Society for
Immunotherapy of Cancer 37th Annual Meeting. The company’s two
poster presentations covered the PK/PD, safety and anti-tumor
activity of MDNA11 at that time point.
In September 2022, Medicenna announced a
clinical collaboration with Merck to evaluate MDNA11 in combination
with KEYTRUDA® (pembrolizumab) in the ABILITY trial.
Bizaxofusp (formerly MDNA55): Empowered IL-4 Superkine
Program
In January 2023, topline results from the
single-arm Phase 2b clinical trial of MDNA55 were published in the
peer reviewed journal, Neuro-Oncology. The study, in patients with
recurrent unresectable glioblastoma, met its primary endpoint,
allowing for alignment with U.S. Food and Drug Administration
(“FDA”) on an innovative, open-label hybrid design for a potential
pivotal trial.
Preclinical Pipeline
Programs
In April 2023, Medicenna presented preclinical
data characterizing IL-13 Superkines and next-generation Superkines
at the 2023 Annual Meeting of the American Association for Cancer
Research. The preclinical data demonstrated that two IL-13
Superkines, MDNA132 and MDNA213, exhibit highly selective binding
to the IL-13 decoy receptor (IL-13Rα2) and, in a mouse model,
selectively accumulate in the tumor microenvironment for several
days. The presentation also characterized a series of
next-generation IL-13 Superkines.
In September 2022, Medicenna presented
preclinical data demonstrating anti-tumor activity of an
anti-PD1-IL-2 BiSKIT™ and long-acting IL-4/IL-13 super-antagonist
at the 10th Annual Meeting of the International Cytokine &
Interferon Society. The data demonstrated that single agent
anti-PD1-IL-2 BiSKIT™ showed superior efficacy compared to a
combination of an anti-PD1 antibody with an IL-2 Superkine in
murine models of colon, skin, and breast cancer; and IL-4/IL-13
super-antagonist displayed monotherapy activity in multiple cancer
models and synergy in combination with an IL-2 superkine.
Operational Highlights
In February 2023, Medicenna established an
at-the-market offering facility with Oppenheimer & Co. Inc.
whereby, Medicenna may sell common shares with an aggregate
offering price of up to US$10 million.
In August 2022, Medicenna raised U.S. $20
million in a public offering. The proceeds are being used to fund
pipeline advancement.
Expected Upcoming Milestones
Initial anti-tumor activity data from ABILITY’s
fifth and sixth dose escalation cohort expected in calendar Q3
2023.
Commencement of the ABILITY study’s Phase 2
single agent dose expansion portion expected in calendar Q3
2023.
Clinical update from the ABILITY study’s Phase 2
single agent portion expected in calendar Q4 2023.
Commencement of the ABILITY study’s Phase 2
combination portion (MDNA11 plus KEYTRUDA®) expected in calendar Q4
2023.
Annual Financial Results
As of March 31, 2023, cash and cash equivalents
were $33.6 million, compared to $20.5 million on March 31, 2022.
These funds are expected to provide the Company with sufficient
capital to execute its current planned expenditures through the key
milestones of the ABILITY study and through calendar Q3 2024 based
on its current plans and projections.
Net loss for the year ended March 31, 2023, was
$10.0 million, or $0.16 per share, compared to a loss of $22.6
million, or $0.42 per share, for the year ended March 31, 2022.
The decrease in net loss for the year ended
March 31, 2023 was a result of decreased research and development
expenditures related to the MDNA11 program, a foreign exchange gain
of $1.6 million and a non-cash change in the fair value of the
warrant derivative (gain) of $4.3 million further contributed to
the reduction in net loss. These reductions were partially offset
by a reimbursement of $1.8 million under the CPRIT grant in the
year ended March 31, 2022 which reduced R&D expenditures in the
year ended March 31, 2022.
Research and development expenses of $9.3
million were incurred during the year ended March 31, 2023,
compared with $14.7 million incurred in the year ended March 31,
2022. The decrease in research and development expenses in the
current fiscal year is primarily attributed to costs associated
with the development of MDNA11 incurred in the year ended March 31,
2022 including GMP manufacturing and IND enabling studies for which
no comparable expenses were incurred in the current year. The
reduction in MDNA11 development expenses was partially offset by
higher clinical costs in the current year period.
General and administrative expenses of $7.0
million were incurred during the year ended March 31, 2023,
compared with $7.8 million during the year ended March 31, 2022.
The decrease in G&A expenses in the year ended March 31, 2023
primarily relates to a reduction in directors and officers
liability insurance premiums.
Medicenna’s financial statements for the year
ended March 31, 2023 and the related management’s
discussion and analysis (“MD&A”) will be available on SEDAR
at www.sedar.com and on EDGAR at www.sec.gov.
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 potential of MDN11 to demonstrate
its positive attributes by further bolstering its efficacy and the
expectation that current cash on hand will be sufficient to fund
operations through key milestones in 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 Report on Form 20-F of the
Company and in other filings made by the Company with the
applicable securities regulators from time to time
in Canada and in 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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