- Received U.S. Food and Drug Administration
(“FDA”) Breakthrough Therapy Designation (“BTD”) for CYB003, its
proprietary deuterated psilocybin analog in development for the
adjunctive treatment of Major Depressive Disorder (“MDD”) -
- Clinical site selection complete for Phase 3
multinational study of CYB003, which is expected to begin in summer
2024 -
- Cash totaled C$209 million as of March 31,
2024 -
- Initiated a Phase 2 study of CYB004, its
proprietary deuterated dimethyltryptamine (“DMT”) program in
development for the treatment of Generalized Anxiety Disorder
(“GAD”) -
- Strengthened intellectual property portfolio
with more than 60 granted patents and over 200 pending applications
-
- Closed oversubscribed private placement of
U.S.$150 million (the “Private Placement”) led by a syndicate of
leading biopharmaceutical institutional investors -
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, as amended December 22, 2023 and April 8,
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 treatment options for
mental health disorders, today reported audited financial results
for its fiscal year ended March 31, 2024, and recent business
highlights.
“I am proud of the swift and meaningful progress we have made
advancing our two lead programs – CYB003 for the adjunctive
treatment of MDD and CYB004 for the treatment of GAD – this past
year. As we stand poised to commence our Phase 3 study of CYB003,
Cybin has evolved into a mature, late-stage company with critical
milestones on the near-term horizon,” stated Doug Drysdale, Chief
Executive Officer of Cybin. “Supported by the BTD from the FDA and
positive four-month durability data for our CYB003 program, and the
initiation of our Phase 2 study of CYB004, we are progressing
quickly to potentially change the treatment paradigm for MDD and
GAD and bring to market innovative treatment options for patients
in need.”
“The path towards approval and commercialization for such novel
therapeutics is gaining clarity. We believe our rigorous research
and novel clinical approach can lead to a wholesale transformation
in how mental health disorders are treated and ultimately, to
improved outcomes for patients and their families. Cybin’s momentum
continues, and 2024 will be another year of regulatory engagement
and acceleration for our lead clinical programs. We are grateful
for the financial support to continue this important work and look
forward to sharing future updates on our progress,” concluded
Drysdale.
Recent Business and Pipeline Highlights:
CYB003: Lead program with FDA BTD for the adjunctive
treatment of MDD. This is the first known BTD granted by the
FDA for an adjunctive psychedelic based therapy for the potential
treatment of MDD. BTD provides an expedited review pathway and
increased access to FDA guidance on trial design, with the
potential to reduce drug development timelines. The designation
includes all “fast track” program features, as well as more
intensive FDA guidance and discussion of the CYB003 development
program, including planned clinical trials and plans for expediting
the manufacturing development strategy. BTD is supported by the
Company’s positive topline results from its Phase 2 study of CYB003
in MDD, which demonstrated a robust, and clinically significant
reduction in depressive symptoms after a single dose with a mean 14
point MADRS score reduction from baseline between CYB003 (12mg) vs.
placebo (p=0.0005) at three weeks. At six weeks, 79% of patients
were in remission from depression after receiving two doses of
CYB003 (12mg).
Announced positive four-month durability data for CYB003 in
MDD supporting progression to a pivotal Phase 3 multinational study
of CYB003 in summer 2024. Robust and sustained improvements in
symptoms of depression were observed with two doses of 12mg or 16mg
of CYB003:
- Mean reduction from baseline in the MADRS total score was
approximately 22 points from baseline in both dosing cohorts.
- Approximately 75% of the patients were responders (>/= 50%
improvement in MADRS scores) following two doses of 16mg.
- 60% of patients on 12mg and 75% on 16mg were in remission from
depression following 2 doses (MADRS score </= 10).
CYB003 was well tolerated with no drug-related serious adverse
events. All adverse events were mild or moderate in intensity.
There were no incidents of suicidal ideation or behavior and no
discontinuations due to adverse events.
Announced a positive End-of-Phase 2 meeting and alignment
with the FDA on the CYB003 pivotal program design. The Company
expects to initiate enrollment for the multinational, multisite
Phase 3 program in summer of 2024.1 This is expected to be
the first Phase 3 trial evaluating a deuterated psilocybin analog
for the adjunctive treatment of MDD. Clinical site selection is
complete for the first Phase 3 study, which will include thirty
study sites across the United States and Europe, all of which are
experienced with conducting psychedelic clinical trials.
CYB004: Initiated Phase 2 study of the Company’s
proprietary deuterated DMT molecule in development for the
treatment of GAD. In January 2024, the FDA cleared the
Company’s Investigational New Drug application for CYB004. CYB004
is being developed as a potentially highly scalable intermittent
treatment. A single intramuscular dose is expected to result in
acute psychedelic effects lasting approximately 90 minutes. Results
from this study are expected to provide proof-of-concept for
CYB004’s efficacy in GAD, time to onset of effects, and durability
of effects to one year.
Strengthened patent portfolio with the addition of 4 new
patents in key jurisdictions.
- The United States Patent and Trademark Office (“USPTO”) granted
U.S. patent 11,958,807 in support of its CYB003 program. The patent
includes claims to pharmaceutical compositions within the Company’s
CYB003 program and is expected to provide exclusivity until at
least 2041.
- The Canadian Patent Office granted CA patent 3,179,335 and the
Chinese Patent Office granted CN patent ZL202180044031.5 in support
of the Company’s CYB004 program. The patents include claims to
pharmaceutical compositions within the CYB004 program and are
expected to provide exclusivity until at least 2041.
- The Chinese Patent Office granted CN patent ZL202080087092.5 in
support of the Company’s CYB004 program. This patent includes
claims to methods of synthesis of compounds within the CYB004
program and is expected to provide exclusivity until at least
2040.
Upcoming Clinical Milestones and Future Studies:1
CYB003 - Deuterated Psilocybin Analog Program
- Initiate a multinational, multisite Phase 3 program in summer
of 2024 to further evaluate the safety and efficacy of CYB003
capsules as a potential adjunctive treatment in a larger MDD
patient population.
CYB004 – Deuterated DMT Program
- Topline safety and efficacy readout from Phase 2 GAD study
expected around year end 2024.
Financial highlights
- Cash totaled C$209 million as of March 31, 2024.
- With the completion of the Private Placement and a combination
of the Company's current cash position, current at-the-market
equity program (“ATM Program”), the Company has access to over
C$285 million.2
- Net loss was C$21 million for the quarter ended March 31, 2024,
compared to a net loss of C$14 million in the same period last
year.
- Net loss was C$78 million for the year ended March 31, 2024,
compared to a net loss of C$47 million in the same period last
year.
- Cash-based operating expenses consisting of research, general,
and administrative costs totaled C$24 million for the quarter ended
March 31, 2024, compared to C$13 million, in the prior year
quarter.
- Cash-based operating expenses consisting of research, general,
and administrative costs totaled C$65 million for the year ended
March 31, 2024, compared to C$47 million, in the prior year.
- Cash flows used in operating activities were C$21 million for
the quarter ended March 31, 2024, compared to C$11 million in the
same period last year.
- Cash flows used in operating activities were C$69 million for
the year ended March 31, 2024, compared to C$47 million in the same
period last year.
- Cash flows received from financing activities were C$254.5
million for the year ended March 31, 2024, compared to C$13.6
million in the same period last year, related to the net proceeds
on the issuance of common shares through the Private Placement, a
public offering completed on August 4, 2023, a public offering
completed on November 14, 2023, a common share purchase agreement
with Lincoln Park Capital Fund, LLC and the ATM Program.
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, 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 Company on X,
LinkedIn, YouTube and Instagram.
Notes
1. There is no assurance that timelines will be met. Anticipated
timelines regarding the initiation, advancement and results of
clinical trials are based on reasonable assumptions informed by
current knowledge and information available to the Company. See
“Cautionary Notes and Forward-Looking Statements”.
2. There can be no assurance that the Company will be successful
in obtaining additional capital under the ATM Program.
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 plans to progress to a Phase 3 trial of
CYB003 in summer 2024; the release of topline Phase 2 CYB004 data
around year-end 2024; the Company’s ability to access capital under
the ATM Program; and the Company’s plans to engineer proprietary
drug discovery platforms, innovative drug delivery systems, novel
formulation approaches and treatment regimens for mental health
conditions.
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: 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; implications of disease outbreaks on the
Company's operations; and the risk factors set out in each of the
Company's management's discussion and analysis for the year ended
March 31, 2024 and the Company’s annual information form for the
year ended March 31, 2024, 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. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240625020753/en/
Investor & Media Contact: Gabriel Fahel Chief Legal
Officer Cybin Inc. 1-866-292-4601 irteam@cybin.com – or –
media@cybin.com