- All-share transaction creates international
clinical-stage leader in novel psychedelic therapeutics -
- Two proprietary, advanced clinical programs
in development for depression and anxiety disorders with
demonstrated safety and efficacy -
- Combined portfolio creates 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
28 patents granted and 158 patents pending -
- Creates strong synergies by combining key
assets, personnel, capabilities and intellectual property, as well
as access to world-leading scientific and clinical collaborators
-
- Multinational operations support scaling to
Phase 3 development of CYB003 in early 2024, following planned
Phase 2 safety and efficacy readout in late 2023 -
- Cybin and Small Pharma to host conference
call today, August 28, 2023, at 11:30 a.m. ET -
(Dollar amounts expressed in Canadian
dollars)
Cybin Inc. (NYSE American:CYBN) (NEO:CYBN) (“Cybin”), a
clinical-stage biopharmaceutical company committed to
revolutionizing mental healthcare by developing new and innovative
psychedelic-based treatment options, and Small Pharma Inc.
(TSXV:DMT) (OTCQB:DMTTF) (“Small Pharma”), a U.K.-based
biotechnology company focused on short-duration psychedelic
therapies for mental health conditions, today announced that they
have entered into a definitive arrangement agreement (the
“Agreement”) pursuant to which Cybin will acquire all of
Small Pharma’s issued and outstanding securities in an all-share
transaction pursuant to a plan of arrangement (the
“Transaction”).
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the full release here:
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Under the terms of the Transaction, Small Pharma shareholders
will receive 0.2409 common shares in the capital of Cybin
(“Cybin Shares”) for each common share of Small Pharma
(“Small Pharma Share”) held. The exchange ratio implies
consideration of approximately $0.10 per Small Pharma Share based
on the closing price of the Cybin Shares on the Cboe Canada
exchange (“Cboe Canada”) on August 25, 2023, representing a
43.64% premium based on the 30-day volume weighted average prices
of the Cybin Shares on the Cboe Canada and the Small Pharma Shares
on the TSX Venture Exchange (“TSXV”) for the period ended on
August 25, 2023. As of the date of this press release, it is
expected that existing Cybin shareholders and Small Pharma
securityholders will own approximately 74.5% and 25.5% of Cybin,
respectively.
The Agreement has been unanimously approved by Small Pharma’s
board of directors (the “Small Pharma Board”) on the
unanimous recommendation of a special committee of its independent
directors (the “Small Pharma Special Committee”), and
Cybin’s board of directors (the “Cybin Board”).
“This transaction creates a clear market leader in novel
psychedelic therapeutics. The synergy of Cybin’s and Small Pharma’s
development programs, intellectual property, and robust datasets
enhances our leadership and expertise in developing potentially
best-in-class, optimized psychedelic therapeutics, and positions
the combined company to generate long-term value for all
stakeholders. Our combined portfolios, having an increased number
of potential value-catalysts, also create added opportunities to
support future funding activities with no added debt. We look
forward to welcoming our Small Pharma colleagues into the Cybin
team,” said Doug Drysdale, Chief Executive Officer of Cybin.
Small Pharma is a leader in the development of short-duration
psychedelic therapies for mental health conditions, having raised a
total of $63 million in capital since 2021, and demonstrating the
first placebo-controlled efficacy results for
N,N-dimethyltryptamine (“DMT”) in treating Major Depressive
Disorder (“MDD”). In the past years Small Pharma has
progressed two clinical-stage DMT-based programs, a pipeline of
preclinical assets, and developed a highly robust intellectual
property (“IP”) portfolio to protect them.
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 DMT and deuterated DMT
(“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.
The combined entity will hold the most impressive IP portfolio
in the psychedelic drug development sector, with a combined 158
pending patent applications, including two allowed applications,
and 28 granted patents protecting the combined companies’ clinical
and preclinical molecules. This extensive IP portfolio creates an
unmatched opportunity for the combined company to develop
next-generation novel compounds for a number of mental health
disorders that may be amenable to treatment with psychedelic
therapies.
George Tziras, Chief Executive Officer of Small Pharma, said,
“This marks the beginning of an exciting new chapter for Small
Pharma. Since 2015, we have been committed to our mission of
accelerating patient access to transformative mental health
treatments, and I am incredibly proud of the progress we have made.
Cybin shares both our vision and confidence in the potential of our
programs. Cybin’s senior listing on the NYSE American can also
provide increased access to the broader and deeper capital markets
of the United States. We look forward to combining the considerable
strengths of our teams to create a category leader in novel
psychedelic-based therapeutics and bring innovative mental health
treatments to patients around the world.”
Together, the combined operating teams of Cybin and Small Pharma
create a sector-leading organization with deep expertise in DMT and
deuterated psychedelic tryptamine-based therapeutics for mental
health disorders. The integrated DMT dataset from both companies
represents an advanced and extensive DMT clinical program,
including:
- Phase 2 safety and efficacy data for IV DMT in patients with
MDD (SPL026);
- Extensive Phase 1 dataset for IV formulations of DMT and dDMT
(CYB004e, CYB004, SPL026, SPL028);
- Studies exploring more convenient and patient-friendly dosing
methods (Phase 1 intramuscular SPL026 and SPL028; subcutaneous
CYB004); and
- Phase 1b safety and efficacy of SPL026 administered in
conjunction with serotonin reuptake inhibitors (“SSRIs”) in
patients with MDD, with data anticipated in late 2023. Encouraging
results could broaden access to DMT-based therapies by removing the
requirement for patients to be withdrawn from existing SSRI
medication.
Data readouts from both companies’ 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 CYB003 deuterated psilocybin analog program in participants
with MDD, in late 2023. Plans are underway to scale the program for
Phase 3, including a partnership with a global clinical research
organization, a streamlined EMBARKCT facilitator training program,
and preparations for Good Manufacturing Practice (GMP)
manufacturing of CYB003 capsules for pivotal clinical trial
supplies. Cybin was recently granted a composition of matter patent
covering a deuterated psilocybin analog in its CYB003 program, and
anticipates the potential for receiving Breakthrough Therapy
designation from the U.S. Food and Drug Administration
(“FDA”), subject to FDA approval, as early as late 2023.
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. 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.
Additional Transaction Details
Pursuant to the Transaction, Small Pharma shareholders will
receive 0.2409 Cybin Shares for each Small Pharma Share held.
Holders of options to purchase Small Pharma Shares that are
“in-the-money” based on the volume weighted average trading price
of the Small Pharma Shares on the TSXV for the five trading days
immediately preceding the effective time of the Transaction (the
“Small Pharma Share Value”) will receive from Small Pharma a
number of Small Pharma Shares equal to the number of Small Pharma
options held, multiplied by the amount by which the Small Pharma
Share Value exceeds the exercise price of such Small Pharma
options, divided by the Small Pharma Share Value. Such newly issued
Small Pharma Shares will be acquired by Cybin on the same terms as
the other Small Pharma Shares. Each Small Pharma option that is
“out-of-the-money” based on the Small Pharma Share Value will be
deemed to be surrendered to Small Pharma for $0.001 and
cancelled.
The Transaction will be effected by way of a court-approved plan
of arrangement under the Business Corporations Act (British
Columbia), requiring the approval of at least 662/3% of the votes
cast by the shareholders of Small Pharma voting in person,
virtually or by proxy at an annual and special shareholders’
meeting to consider, in addition to certain annual business, the
Transaction. The issuance of Cybin Shares pursuant to the
Transaction will also require approval by a simple majority of the
votes cast by the shareholders of Cybin voting virtually or by
proxy at an annual and special meeting of Cybin shareholders, in
accordance with the polices of the Cboe Canada. The shareholders’
meetings are expected to occur on or about October 12, 2023.
In connection with the Transaction, each of Small Pharma’s
directors and officers, and Small Pharma’s largest shareholder, who
collectively beneficially hold or exercise control or direction
over, directly or indirectly, an aggregate of approximately 28.8%
of the outstanding Small Pharma Shares, have entered into voting
and support agreements with Cybin, pursuant to which each of them
has agreed, among other things, to support and vote their Small
Pharma Shares in favour of the Transaction. In addition, each of
Cybin’s directors and officers, and certain Cybin shareholders, who
collectively hold or exercise control or direction over an
aggregate of approximately 17% of the outstanding Cybin Shares,
have entered into voting and support agreements with Small Pharma,
pursuant to which each of them has agreed, among other things, to
support and vote their Cybin Shares in favour of the
Transaction.
In addition to shareholder approvals, the Transaction is subject
to approval by the Supreme Court of British Columbia, receipt of
applicable stock exchange and regulatory approvals, including the
approval of the TSXV, and the satisfaction of certain other closing
conditions customary in transactions of this nature. It is
currently expected that the Transaction will close in late October
2023.
The Agreement includes customary reciprocal “non-solicitation”
covenants, subject in the case of “fiduciary out” provisions that
would permit Small Pharma to accept a superior proposal under
certain circumstances, subject to a “right to match” period in
favour of Cybin. The Agreement also provides for reciprocal
termination fees of $2 million payable to Cybin or Small Pharma if
the Transaction is terminated in certain specified circumstances,
and, in certain other customary circumstances, expense
reimbursement payable to Small Pharma of $400,000.
Upon completion of the Transaction, the Cybin Board will be
increased by one director, and George Tziras, the current Chief
Executive Officer of Small Pharma, will join the Cybin Board.
Further information regarding the Transaction will be included
in the respective management information circulars of Cybin and
Small Pharma, which will be mailed to shareholders in connection
with their respective shareholder meetings. The Agreement will be
filed on the SEDAR+ profiles of Small Pharma and Cybin at
www.sedarplus.ca and with the U.S. Securities and Exchange
Commission on EDGAR at www.sec.gov.
Board of Directors’ Recommendations
The Small Pharma Board has unanimously determined, after
receiving the unanimous recommendation of the Small Pharma Special
Committee, that the Transaction is fair to the Small Pharma
shareholders, and in the best interests of Small Pharma, and has
unanimously recommended that Small Pharma shareholders vote in
favour of the Transaction. The Cybin Board has unanimously
determined that the Transaction is in the best interests of Cybin,
and has unanimously recommended that Cybin shareholders vote in
favour of the Transaction.
The Small Pharma Board has received the opinion of Jefferies
International Limited to the effect that, as of August 28, 2023 and
based on and subject to the various assumptions made, procedures
followed, matters considered and limitations and qualifications on
the review undertaken set forth therein, the exchange ratio
provided for pursuant to the Agreement was fair, from a financial
point of view, to the holders of Small Pharma Shares (other than,
as applicable, Cybin and its affiliates).
Upon completion of the Transaction, it is expected that the
Small Pharma Shares will be delisted from the TSXV and removed from
the OTCQB market, and Small Pharma will cease to be a reporting
issuer in each of the provinces and territories in Canada.
The combined company will remain headquartered in Toronto, with
operations in Canada, the U.S., the U.K., the Netherlands, and
Ireland, and will continue to trade on the NYSE American and the
Cboe Canada under the ticker “CYBN”.
None of the securities to be issued pursuant to the Transaction
have been or will be registered under the United States Securities
Act of 1933, as amended (the “U.S. Securities Act”), or any
state securities laws, and any securities issuable in the
Transaction are anticipated to be issued in reliance upon available
exemptions from such registration requirements pursuant to Section
3(a)(10) of the U.S. Securities Act and applicable exemptions under
state securities laws. This press release does not constitute an
offer to sell or the solicitation of an offer to buy any
securities.
Legal and Financial Advisors
Gowling WLG (Canada) LLP is acting as legal counsel to
Cybin.
Aird & Berlis LLP is acting as legal counsel to Small Pharma
and the Small Pharma Special Committee. Jefferies International
Limited is acting as exclusive financial advisor to Small
Pharma.
Conference Call and Webcast Details
Cybin and Small Pharma will host a conference call on August 28,
2023 at 11:30 a.m. ET.
To join the conference call via telephone, please register here
to receive the dial-in information.
To join the live audio webcast of the call, please register
here.
The archived webcast will also be available on Cybin’s investor
relations website on the Events & Presentations page and on the
Investor page of Small Pharma’s website under Events &
Conferences.
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
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 Twitter,
LinkedIn, YouTube and Instagram.
About Small Pharma
Small Pharma is a biotechnology company progressing a pipeline
of short-duration psychedelic-assisted therapies for the treatment
of mental health conditions. Small Pharma has a portfolio of
clinical-stage DMT-based assets, SPL026 and SPL028. Small Pharma
was granted an Innovation Passport designation for SPL026 from the
U.K. Medicines and Healthcare products Regulatory Agency and has a
pipeline of proprietary preclinical assets.
Small Pharma is focused on developing short-duration
tryptamine-based therapeutics that are scalable, commercially
differentiated, and conveniently dosed, with the goal of addressing
key unmet needs in the treatment of depression. Small Pharma’s lead
clinical-stage program, SPL026, a first-generation DMT molecule,
has shown proof-of-concept for the potential treatment of MDD. In a
Phase 2a study, IV SPL026 demonstrated a rapid and durable
antidepressant effect, as well as a favorable safety and
tolerability profile. Small Pharma is also advancing SPL028, a
second-generation injectable deuterated DMT molecule, in a Phase 1
trial.
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 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; the
possibility of obtaining FDA Breakthrough Therapy designation for
CYB003, and the timing for receiving such designation; full data
readouts from both companies’ Phase 1 deuterated programs, CYB004
and SPL028 in late 2023; anticipated timing of Small Pharma’s Phase
1b safety and efficacy data in respect of SPL026; anticipated
launch of a Phase 2 efficacy study of dDMT in early 2024; the
anticipated timing for the meetings of Cybin and Small Pharma
shareholders and closing of the Transaction; the consideration to
be received by Small Pharma shareholders; the estimated value of
the Transaction; the delisting and removal of the Small Pharma
Shares from the TSXV and OTCQB, respectively; the satisfaction of
closing conditions to the Transaction, including, without
limitation (i) the required Cybin shareholder approval; (ii) the
required Small Pharma shareholder approval; (iii) necessary court
approval in connection with the plan of arrangement; (iv) the
appointment of a Small Pharma nominee to the Cybin Board; (v) Cybin
obtaining the necessary approvals from the Cboe Canada and NYSE
American for the listing of securities in connection with the
Transaction; and (vi) other closing conditions, including, without
limitation, obtaining certain consents and other regulatory
approvals, as applicable, the operation and performance of the
Cybin and Small Pharma businesses in the ordinary course until
closing of the Transaction and compliance by Cybin and Small Pharma
with various covenants contained in the Agreement; Small Pharma
ceasing to be a reporting issuer in each of the provinces and
territories in Canada; and the anticipated benefits of the
Transaction to shareholders and the combined company, including
corporate operational, and other synergies.
These forward-looking statements are based on reasonable
assumptions and estimates of management of the Cybin and Small
Pharma 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 Cybin and Small
Pharma to materially differ from any future results, performance,
or achievements expressed or implied by such forward-looking
statements. Such factors, among other things, include: that the
Transaction may not be completed on the expected terms or within
expected timelines, or at all; the Transaction may not be approved
by the Cybin shareholders and/or the Small Pharma shareholders;
applicable stock exchange and other regulatory approvals may not be
obtained on terms satisfactory to Cybin and Small Pharma, or at
all; the combined company may be unable to realize the anticipated
benefits of, and synergies and savings from, the Transaction;
implications of the spread of COVID-19 on the operations of Cybin
and Small Pharma; fluctuations in general macroeconomic conditions;
fluctuations in securities markets; expectations regarding the size
of the psychedelics market; the ability of Cybin and Small Pharma
to successfully achieve their 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 Cybin and Small Pharma
operate; the risk that the potential product candidates that Cybin
and Small Pharma develop may not progress through clinical
development or receive required regulatory approvals or
Breakthrough Therapy designation within expected timelines or at
all; risks relating to uncertainty regarding the regulatory pathway
for Cybin and Small Pharma product candidates; the risk that Cybin
and Small Pharma will be unable to successfully market or gain
market acceptance of their product candidates; and the risk factors
set out Cybin’s management’s discussion and analysis for the three
months ended June 30, 2023, and annual information form for the
year ended March 31, 2023, are available under Cybin’s SEDAR+
profile at www.sedarplus.ca and with the U.S. Securities and
Exchange Commission on EDGAR at www.sec.gov, and Small Pharma’s
management’s discussion and analysis for the three months ended May
31, 2023, which is available on Small Pharma’s SEDAR+ profile at
www.sedarplus.ca.
Although the forward-looking statements contained in this news
release are based upon what management of Cybin and Small Pharma
respectively believes to be reasonable assumptions, there can be no
assurance 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. Neither
Cybin nor Small Pharma assumes any 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, the European Medicines Agency, the United Kingdom
Medicines and Healthcare products Regulatory Agency, 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. Neither Cybin nor Small Pharma has 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 or Small Pharma verified
such in clinical trials or that Cybin or Small Pharma will complete
such trials. If Cybin or Small Pharma cannot obtain the approvals
or research necessary to commercialize its business, it may have a
material adverse effect on the performance and operations of Cybin
or Small Pharma.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230828350890/en/
Cybin Investor & Media Contact: Gabriel Fahel Chief
Legal Officer Cybin Inc. 1-866-292-4601 irteam@cybin.com – or –
media@cybin.com Small Pharma Inc. & Investor Relations:
George Tziras Chief Executive Officer Small Pharma Inc.
ir@smallpharma.co.uk Small Pharma Media Relations: Jenny
Maguire Head of External Affairs Small Pharma Inc.
jenny.maguire@smallpharma.co.uk
Small Pharma (TSXV:DMT)
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