Opthea Limited (ASX:OPT; NASDAQ:OPT), a clinical-stage
biopharmaceutical company developing novel therapies to treat
highly prevalent and progressive retinal diseases, today announced
that it expects to receive the remaining US$35 million committed
funds under the Development Funding Agreement (DFA) with Carlyle
and Abingworth, and has entered into binding documentation with a
new co-investor under an Amended DFA to secure an additional US$50
million in funding.
Under the terms of the DFA, Carlyle and
Abingworth committed US$120 million, of which US$85 million has
been received to date. The remaining committed funds of US$35
million and the additional US$50m announced today will be received
on or around December 31, 2023, bringing the total committed
funding under the amended DFA to US$170 million, the maximum amount
allowed under the terms of the DFA.
Dr. Fred Guerard, Chief Executive Officer of
Opthea Limited, commented, “We are extremely pleased with this
funding that demonstrates investors’ confidence in sozinibercept
and its potential for future clinical, regulatory and commercial
success. Both global pivotal trials in wet AMD (COAST and ShORe)
are now over 80% enrolled, and aim at confirming the superior
efficacy outcomes observed in Opthea’s Phase 2b trial.”
This total US$85 million funding will be used to
advance Opthea’s Phase 3 clinical trials and pre-commercialization
activities of sozinibercept for wet AMD.
Under the terms of the DFA, if sozinibercept is
approved in a major market, Opthea will make a milestone payment
after regulatory approval and then six subsequent annual fixed
success payments and variable success payments of 7% of net sales,
with cumulative payments capped at four times the amount funded to
Opthea. Opthea retains full worldwide commercial rights for
sozinibercept and has the option to prepay its obligations in full
at any time. The foregoing description of certain terms of the DFA
is qualified in its entirety by reference to the full text of the
Amended DFA, which will be separately filed with the Securities and
Exchange Commission.
About sozinibercept
Sozinibercept (OPT-302) is a soluble form of
vascular endothelial growth factor receptor (VEGFR)-3 expressed as
an immunoglobulin G1 (IgG1) Fc-fusion protein. It binds and
neutralizes the activity of vascular endothelial growth factor
(VEGF)-C and VEGF-D on their endogenous receptors, VEGFR-2 and
VEGFR-3. Targeted inhibition of VEGF-C and VEGF-D can prevent blood
vessel growth and vascular leakage, which contribute to the
pathophysiology of retinal diseases including neovascular “wet”
AMD.
About ShORe and COAST Phase 3 Clinical
Studies
Opthea currently is enrolling patients for its
two ongoing concurrent Global pivotal Phase 3 clinical trials for
the treatment of wet AMD. The multi-center, double-masked,
sham-controlled Phase 3 ShORe (Study of OPT-302 in combination with
Ranibizumab) and COAST (Combination OPT-302 with Aflibercept
Study;) clinical trials will each enroll approximately 990
treatment-naïve patients and assess the efficacy and safety of
intravitreal 2.0 mg sozinibercept in combination with 0.5 mg
ranibizumab (Lucentis®) (ShORe trial) or 2.0 mg aflibercept
(Eylea®) (COAST trial), compared to ranibizumab or aflibercept
monotherapy, respectively. In addition, extended durability of the
sozinibercept treatment effect on clinical outcomes with less
frequent every eight-weekly dosing will be compared with
sozinibercept administered on an every four-weekly dosing regimen,
in combination with each VEGF-A inhibitor. If successful, the
investigation of sozinibercept in combination with two approved
standard of care VEGF-A inhibitors in the Phase 3 program could
enable sozinibercept to be administered with either Eylea or
Lucentis which had combined sales for retinal diseases of
>USD$12 billion in 2022. The primary endpoint for both trials is
the mean change in Best Corrected Visual Acuity from baseline to
week 52 for sozinibercept combination therapy compared to
anti-VEGF-A monotherapy. Patients will continue to be treated for a
further year to evaluate extended safety and tolerability over a
two-year period. To learn more, visit www.opthea.com and
ClinicalTrials.gov (ShORe trial, ID#: NCT04757610; COAST trial,
ID#: NCT04757636).
About Opthea
Opthea (ASX:OPT; NASDAQ:OPT) is a
biopharmaceutical company developing novel therapies to address the
unmet need in the treatment of highly prevalent and progressive
retinal diseases, including wet age-related macular degeneration
(wet AMD) and diabetic macular edema (DME). Opthea’s lead product
candidate sozinibercept is in pivotal Phase 3 clinical trials and
being developed for use in combination with anti-VEGF-A
monotherapies to improve overall efficacy and deliver superior
vision gains over that which can be achieved by inhibiting VEGF-A
alone. To learn more, visit www.opthea.com and follow us on
Twitter and LinkedIn.
Inherent risks of Investment in Biotechnology
Companies
There are a number of inherent risks associated
with the development of pharmaceutical products to a marketable
stage. The lengthy clinical trial process is designed to assess the
safety and efficacy of a drug prior to commercialization and a
significant proportion of drugs fail one or both of these criteria.
Other risks include uncertainty of patent protection and
proprietary rights, whether patent applications and issued patents
will offer adequate protection to enable product development, the
obtaining of necessary drug regulatory authority approvals and
difficulties caused by the rapid advancements in technology.
Companies such as Opthea are dependent on the success of their
research and development projects and on the ability to attract
funding to support these activities. Investment in research and
development projects cannot be assessed on the same fundamentals as
trading and manufacturing enterprises. Therefore, investment in
companies specializing in drug development must be regarded as
highly speculative. Opthea strongly recommends that professional
investment advice be sought prior to such investments.
Forward-looking Statements
This ASX announcement contains certain
forward-looking statements, including within the meaning of the
U.S. Private Securities Litigation Reform Act of 1995. The words
“expect”, “believe,” “should”, “could”, “may”, “will”, “plan” and
other similar expressions are intended to identify forward-looking
statements. Forward-looking statements in this ASX announcement
include statements regarding the additional funding commitment
under the DFA, including satisfaction of conditions to such
commitment and timing of Opthea’s receipt of funding, expectations
regarding the outcomes of Opthea’s Phase 3 clinical trials of
OPT-302, the potential for OPT-302 to improve vision outcomes for
patients with wet AMD, the market opportunity for OPT-302, and the
future performance of Opthea. Forward-looking statements, opinions
and estimates provided in this ASX announcement are based on
assumptions and contingencies which are subject to change without
notice, as are statements about market and industry trends, which
are based on interpretations of current conditions. Forward-looking
statements are provided as a general guide only and should not be
relied upon as an indication or guarantee of future performance.
They involve known and unknown risks and uncertainties and other
factors, many of which are beyond the control of Opthea and its
directors and management and may involve significant elements of
subjective judgment and assumptions as to future events that may or
may not be correct. These statements may be affected by a range of
variables which could cause actual results or trends to differ
materially, including but not limited to the availability of
funding, the receipt of funding under the DFA, including the
co-investor commitment and risks relating to the satisfaction of
conditions to funding, future capital requirements, the
development, testing, production, marketing and sale of drug
treatments, regulatory risk and potential loss of regulatory
approvals, ongoing clinical studies to demonstrate OPT-302 safety,
tolerability and therapeutic efficacy, additional analysis of data
from Opthea’s Phase 3 clinical trials, timing of completion of
Phase 3 clinical trial patient enrollment and CRO and labor costs,
intellectual property protections, and other factors that are of a
general nature which may affect the future operating and financial
performance of the Company. Actual results, performance or
achievement may vary materially from any projections and
forward-looking statements and the assumptions on which those
statements are based. Subject to any continuing obligations under
applicable law or any relevant ASX listing rules, Opthea disclaims
any obligation or undertaking to provide any updates or revisions
to any forward-looking statements in this ASX announcement to
reflect any change in expectations in relation to any
forward-looking statements or any change in events, conditions or
circumstances on which any such statement is based, except as
otherwise required by applicable law.
Authorized for release to ASX by Fred
Guerard, CEO
Company & Media Enquiries:
Rudi Michelson
Monsoon Communications
Tel: +61 (0) 3 9620 3333
Hershel Berry
Blueprint Life Science Group
Tel: +1 415 505 3749
hberry@bplifescience.com
Join our email database to receive program
updates:
Tel: +61 (0) 3 9826 0399 Email: info@opthea.com Web:
www.opthea.com
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