This news release constitutes a “designated
news release” for the purposes of Cybin’s prospectus supplements
each dated August 23, 2023, to its short form base shelf prospectus
dated August 17, 2023.
- Combined portfolios create the industry’s
largest, most advanced, well-protected deuterated DMT program -
- Combination creates the largest intellectual
property portfolio in the psychedelic drug development sector with
over 30 patents granted and 160 patents pending -
- Two proprietary, advanced clinical programs
in development for depression and anxiety disorders with
demonstrated safety and efficacy -
Cybin Inc. (NYSE American:CYBN) (NEO:CYBN) (“Cybin”, or
the “Company”) and Small Pharma Inc. (TSXV:DMT)
(OTCQB:DMTTF) (“Small Pharma”) are pleased to announce the
completion of the previously-announced acquisition by Cybin of
Small Pharma by way of a plan of arrangement under the Business
Corporations Act (British Columbia), and pursuant to the terms of
an arrangement agreement dated August 28, 2023 between Cybin and
Small Pharma (the “Arrangement”). As a result of the
Arrangement, Small Pharma is now a wholly-owned subsidiary of
Cybin.
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“The closing of this transaction marks a significant milestone
in Cybin’s growth trajectory, firmly establishing us as a leader in
the psychedelics sector,” said Doug Drysdale, Chief Executive
Officer of Cybin. “With the industry’s largest, most advanced and
well-protected deuterated N,N-dimethyltryptamine (“dDMT”)
pipeline program and topline efficacy data for CYB003, our
deuterated psilocybin analog program expected this quarter, Cybin
is well positioned with two advanced clinical programs for the
treatment of depression and anxiety disorders with demonstrated
safety and efficacy. Our efforts are also supported by the largest
intellectual property portfolio in the psychedelic drug development
space, with over 30 patents granted and more than 160 patents
pending. We welcome the Small Pharma scientists and leaders who are
joining the Cybin team, as we look to leverage the many synergies
and drive value for shareholders.”
George Tziras, Chief Executive Officer of Small Pharma,
commented, “For the past 8 years, Small Pharma has worked to
develop transformative medicines for patients struggling with
depression. I am incredibly proud of what we as a team have
achieved. This transaction marks the start of an exciting new
chapter for Small Pharma as we bring to Cybin a complementary
portfolio and a talented team. We firmly believe the combined
company will be well positioned to accelerate innovation in the
industry and deliver enhanced value for our shareholders and better
outcomes for patients.”
With a common goal to create novel, optimized psychedelic-based
therapeutics, the combination of Cybin and Small Pharma creates an
international, clinical-stage leader with the potential to
transform the treatment paradigm for mental health conditions.
Cybin’s and Small Pharma’s combined N,N-dimethyltryptamine
(“DMT”) and dDMT programs creates the largest dataset of
systematic research on these short-duration psychedelic molecules.
The companies’ combined development portfolios are highly
complementary and provide multiple opportunities to create
operational and cost synergies.
Data readouts from the combined company’s Phase 1 deuterated
programs, CYB004 and SPL028 are anticipated by late 2023. This will
enable a robust evaluation of formulations and administration
routes, and an informed, data-driven approach to launching a Phase
2 efficacy study of dDMT in the United States early in 2024.
Cybin expects to report Phase 2 safety and efficacy data from
its proprietary CYB003 deuterated psilocybin analog program in
participants with major depressive disorder in late 2023. Plans are
underway to scale the program for Phase 3 in early 2024.
“As a stronger combined organization, there is a lot to look
forward to in the remaining months of 2023 and 2024, as Cybin will
have four studies running in 2024, CYB003, as it moves to Phase 3,
CYB004, as it moves to Phase 2, and two formulation studies focused
on evaluating more convenient dosing regimens,” concluded
Drysdale.
George Tziras said, “To date, we have demonstrated strong proof
of concept for our DMT program, with data to support its rapid and
durable antidepressant effects to at least six months. Importantly,
we have further shown that a DMT-based treatment can be
administered safely in patients taking selective serotonin reuptake
inhibitor antidepressants, and has the potential to enhance
treatment efficacy. As a combined company, the upcoming year offers
the opportunity to make significant advances in our combined
proprietary psychedelic portfolio as we continue to further
validate the treatment potential of these therapies.”
Information for former Small Pharma Shareholders
Under the terms of the Arrangement, each former Small Pharma
shareholder is now entitled to receive 0.2409 common shares of
Cybin (“Cybin Shares”) for each Small Pharma common share
(“Small Pharma Share”) held prior to the Arrangement (the
“Consideration”). Cybin has issued an aggregate of
80,945,300 Cybin Shares to Odyssey Trust Company, as depositary
(the “Depositary”) pursuant to the terms of the Arrangement.
Small Pharma Shares are expected to be delisted from the TSX
Venture Exchange (the “TSXV”) and removed from the OTCQB
Venture Market (the “OTCQB”) in the coming days, and Small
Pharma will apply to cease to be a reporting issuer in each of the
provinces and territories in Canada.
In order to receive the Consideration to which they are
entitled, registered holders of Small Pharma Shares who hold
physical share certificates or DRS statements must submit a letter
of transmittal to the Depositary. A letter of transmittal has
previously been mailed to Small Pharma shareholders in connection
with the annual and special meeting of Small Pharma shareholders
held on October 12, 2023, and is available on Small Pharma’s
profile on SEDAR+ at www.sedarplus.com. Small Pharma shareholders
who hold their Small Pharma Shares through a broker or other
intermediary should follow the instructions provided by such broker
or intermediary.
Cybin Board and Management
The combined company will be led by Cybin’s Chief Executive
Officer, Doug Drysdale, who brings over 30 years of experience in
the healthcare sector. George Tziras, the former Chief Executive
Officer of Small Pharma, has joined the board of directors of Cybin
and will serve as Cybin’s Chief Business Officer, and certain Small
Pharma senior management and staff will be integrated with the
existing Cybin team to create a highly experienced and skilled team
that is well positioned to deliver on the development and clinical
execution of the combined pipeline.
Early Warning Disclosure
For purposes of National Instrument 62-103 – The Early Warning
System and Related Take-Over Bid and Insider Reporting Issues
(“NI 62-103”), prior to the Arrangement, Cybin held no
securities of Small Pharma. On completion of the Arrangement, Cybin
holds 100% of the issued and outstanding Small Pharma Shares. The
Small Pharma Shares were acquired by Cybin in exchange for the
issuance of 0.2409 Cybin Shares for each Small Pharma Share held.
An early warning report will be filed by Cybin pursuant to NI
62-103 and will be available under the Company’s profile on SEDAR+
at www.sedarplus.ca. For further information or to obtain a copy of
the early warning report, please contact Gabriel Fahel, Cybin’s
Chief Legal Officer at 1-866-292-4601 ext. 714 or at Cybin’s head
office located at 100 King St. West, Suite 5600, Toronto, Ontario,
M5X 1C9, Canada.
Legal and Financial Advisors
Gowling WLG (Canada) LLP acted as legal counsel to Cybin.
Aird & Berlis LLP acted as legal counsel to Small Pharma and
the special committee to the Board of Directors of Small Pharma.
Jefferies International Limited acted as exclusive financial
advisor to Small Pharma.
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. Cybin is currently developing
CYB003, a proprietary deuterated psilocybin analog for the
treatment of major depressive disorder and CYB004, a proprietary
dDMT 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 Cybin
and Small Pharma 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 combined company, Cybin’s plans to report Phase 2
safety and efficacy data from its CYB003 deuterated psilocybin
analog program in late 2023; progression to Phase 3 development of
CYB003 in early 2024; data readouts from the Company’s Phase 1
deuterated programs, CYB004 and SPL028 in late 2023; the Company’s
plan to launch a Phase 2 efficacy study of dDMT in the United
States early in 2024; and the anticipated benefits of the
acquisition to shareholders and the combined company, including
corporate operational and other synergies; Small Pharma management
and staff joining Cybin; the delisting of Small Pharma Shares from
the TSXV; removing Small Pharma from the OTCQB; Small Pharma’s
application to cease to be a reporting issuer in all of the
provinces and territories in Canada; and the filing of Cybin’s
early warning report.
These forward-looking statements are based on reasonable
assumptions and estimates of management of the Company or Small
Pharma, as applicable, 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 months ended June 30, 2023,
and the Company’s annual information form for the year ended March
31, 2023, which are available under the Company’s profile on SEDAR+
at 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 or Small Pharma, as applicable, believes,
or believed at the time, to be reasonable assumptions, the Company
and Small Pharma 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 and Small Pharma assume 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.
Small Pharma makes no medical, treatment or health benefit
claims about its proposed products. The MHRA or other similar
regulatory authorities have not evaluated claims regarding
DMT-assisted therapies and other next generation psychoactive
compounds. The efficacy of such therapies has not been confirmed by
MHRA-approved research. There is no assurance that such
DMT-assisted therapies and other psychoactive compounds can
diagnose, treat, cure or prevent any disease or condition. Vigorous
scientific research and clinical trials are needed. Any references
to quality, consistency, efficacy and safety of potential therapies
do not imply that Small Pharma verified such in clinical trials or
that Small Pharma will complete such trials. If Small Pharma cannot
obtain the approvals or research necessary to commercialize its
business, it may have a material adverse effect on Small Pharma’s
performance and operations.
Neither the Neo Exchange Inc. 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.
Neither the TSXV nor its regulation services provider (as that
term is defined in the policies of the TSXV) accepts responsibility
for the adequacy or accuracy of this release.
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Cybin Investor & Media: Gabriel Fahel Chief Legal
Officer Cybin Inc. 1-866-292-4601 irteam@cybin.com – or –
media@cybin.com
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