Cybin Announces Grant of Additional U.S. Patent in Support of its CYB003 Breakthrough Therapy Program for Major Depressive Disorder
April 16 2024 - 7:30AM
Business Wire
- Newly issued patent expected to provide
exclusivity until at least 2041 and includes claims to
pharmaceutical compositions within the Company’s proprietary
deuterated psilocybin analog program -
- Cybin’s patent portfolio now includes more
than 50 granted patents and over 170 pending applications -
- Company expects to commence enrollment for a
multinational, multisite Phase 3 program evaluating CYB003 in Major
Depressive Disorder around mid-year 2024 -
Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin”
or the “Company”), a clinical-stage biopharmaceutical
company committed to revolutionizing mental healthcare by
developing new and innovative next-generation psychedelic-based
treatment options, today announced that the United States Patent
and Trademark Office has granted U.S. patent 11,958,807 in support
of its CYB003 program in Major Depressive Disorder (“MDD”).
The patent, which is expected to provide exclusivity until at
least 2041, includes claims to pharmaceutical compositions within
the Company’s proprietary deuterated psilocybin analog program,
CYB003.
“As we continue to advance CYB003, our deuterated psilocybin
analog program for the adjunctive treatment of MDD, further
protecting our intellectual property through patent protection is
an important achievement,” said Doug Drysdale, Chief Executive
Officer of Cybin. “The strength of our patents supporting CYB003
underscore our commitment to developing innovative,
next-generation, commercially scalable therapeutics to address the
significant unmet medical need in MDD. With our robust patent
portfolio, and the recent Breakthrough Therapy Designation by the
U.S. Food and Drug Administration, we are encouraged by our
regulatory pathway for CYB003 and are positioned to move quickly to
progress the program,” concluded Drysdale.
About Cybin
Cybin is a clinical-stage biopharmaceutical company on a mission
to create safe and effective psychedelic-based therapeutics to
address the large unmet need for new and innovative treatment
options for people who suffer from mental health conditions.
Cybin’s goal of revolutionizing mental healthcare is supported
by a network of world-class partners and internationally recognized
scientists aimed at progressing proprietary drug discovery
platforms, innovative drug delivery systems, and novel formulation
approaches and treatment regimens. The Company is currently
developing CYB003, a proprietary deuterated psilocybin analog for
the adjunctive treatment of major depressive disorder and CYB004, a
proprietary deuterated DMT molecule for generalized anxiety
disorder and has a research pipeline of investigational
psychedelic-based compounds.
Headquartered in Canada and founded in 2019, Cybin is
operational in Canada, the United States, the United Kingdom, the
Netherlands and Ireland. For company updates and to learn more
about Cybin, visit www.cybin.com or follow the team on X, LinkedIn,
YouTube and Instagram.
Cautionary Notes and Forward-Looking Statements
Certain statements in this news release relating to the Company
are forward-looking statements and are prospective in nature.
Forward-looking statements are not based on historical facts, but
rather on current expectations and projections about future events
and are therefore subject to risks and uncertainties which could
cause actual results to differ materially from the future results
expressed or implied by the forward-looking statements. These
statements generally can be identified by the use of
forward-looking words such as “may”, “should”, “could”, “intend”,
“estimate”, “plan”, “anticipate”, “expect”, “believe” or
“continue”, or the negative thereof or similar variations.
Forward-looking statements in this news release include statements
regarding the Company’s plan to commence enrollment for a
multinational, multisite Phase 3 program around mid-year 2024; the
potential reduction in drug development timeline afforded by
Breakthrough Therapy Designation; and the Company’s proprietary
drug discovery platforms, innovative drug delivery systems, novel
formulation approaches and treatment regimens for mental health
disorders.
These forward-looking statements are based on reasonable
assumptions and estimates of management of the Company at the time
such statements were made. Actual future results may differ
materially as forward-looking statements involve known and unknown
risks, uncertainties, and other factors which may cause the actual
results, performance, or achievements of the Company to materially
differ from any future results, performance, or achievements
expressed or implied by such forward-looking statements. Such
factors, among other things, include: implications of the spread of
COVID-19 on the Company's operations; fluctuations in general
macroeconomic conditions; fluctuations in securities markets;
expectations regarding the size of the psychedelics market; the
ability of the Company to successfully achieve its business
objectives; plans for growth; political, social and environmental
uncertainties; employee relations; the presence of laws and
regulations that may impose restrictions in the markets where the
Company operates; and the risk factors set out in each of the
Company's management's discussion and analysis for the three and
nine month periods ended December 31, 2023, and the Company’s
annual information form for the year ended March 31, 2023, which
are available under the Company's profile on www.sedarplus.ca and
with the U.S. Securities and Exchange Commission on EDGAR at
www.sec.gov. Although the forward-looking statements contained in
this news release are based upon what management of the Company
believes, or believed at the time, to be reasonable assumptions,
the Company cannot assure shareholders that actual results will be
consistent with such forward-looking statements, as there may be
other factors that cause results not to be as anticipated,
estimated or intended. Readers should not place undue reliance on
the forward-looking statements and information contained in this
news release. The Company assumes no obligation to update the
forward-looking statements of beliefs, opinions, projections, or
other factors, should they change, except as required by law.
Cybin makes no medical, treatment or health benefit claims about
Cybin’s proposed products. The U.S. Food and Drug Administration,
Health Canada or other similar regulatory authorities have not
evaluated claims regarding psilocybin, psychedelic tryptamine,
tryptamine derivatives or other psychedelic compounds. The efficacy
of such products has not been confirmed by approved research. There
is no assurance that the use of psilocybin, psychedelic tryptamine,
tryptamine derivatives or other psychedelic compounds can diagnose,
treat, cure or prevent any disease or condition. Rigorous
scientific research and clinical trials are needed. Cybin has not
conducted clinical trials for the use of its proposed products. Any
references to quality, consistency, efficacy and safety of
potential products do not imply that Cybin verified such in
clinical trials or that Cybin will complete such trials. If Cybin
cannot obtain the approvals or research necessary to commercialize
its business, it may have a material adverse effect on Cybin’s
performance and operations.
Neither the Cboe Canada nor the NYSE American LLC stock exchange
have approved or disapproved the contents of this news release and
are not responsible for the adequacy and accuracy of the contents
herein.
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Investor & Media: Gabriel Fahel Chief Legal Officer
Cybin Inc. 1-866-292-4601 irteam@cybin.com – or –
media@cybin.com