- Company to host conference
call at 4:30pm EST today –
TORONTO, Canada -- November 15, 2021 -- InvestorsHub NewsWire
-- Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) ("Cybin"
or the "Company"), a biopharmaceutical company
focused on progressing "Psychedelics to TherapeuticsTM",
today reported unaudited financial results for its second quarter
ended September 30, 2021.
"The first half of the year has been a transformative period for
Cybin that included significant and swift advancements in our
research and development pipeline and overall business. Through
CYB003, we believe that we have identified a potentially safer
treatment option for patients with depression and addiction
disorders that we expect to have strong intellectual property
protection and a positive pharmacokinetic profile for patients,
providers and payers. We plan to move through the ongoing,
remaining preclinical studies quickly and submit an investigational
new drug application and clinical trial application in the second
quarter of 20221, in the U.S. and the U.K.,
respectively," said Doug Drysdale, Chief Executive Officer of
Drysdale continued, "In addition, we continue to evolve our
value-driving, patient-centered approach to potential treatments
for mental health and addiction through our commitment to advancing
programs such as EMBARK, that aims to facilitate
psilocybin-assisted psychotherapy for frontline workers impacted by
the COVID-19 pandemic, as well as targeted research using the
Kernel Flow neuroimaging technology that we expect will allow us to
quantitively understand the psychedelic experience in the brain as
it is happening. We believe these programs combined with our
proprietary psychedelic new chemical entities have the potential to
transform the treatment landscape for various psychiatric and
Recent Business and Pipeline Highlights:
- Announced preclinical data for its novel deuterated psilocybin
analog, CYB003, for the potential treatment of major depressive
disorder and alcohol use disorder. The data demonstrated that
CYB003 may provide significant treatment benefits to address the
challenges and limitations of oral psilocybin, including improved
safety through less patient variability, reduced clinic times
through faster onset of action and shorter duration of effect, and
lower dosing through improved brain penetration, which may result
in fewer side effects, ultimately offering an improved patient
experience. Cybin expects to complete the ongoing preclinical
studies of CYB003 in Q1 2022 and submit an investigational new drug
application ("IND") to the U.S. Food and Drug
Administration (the "FDA"), and a clinical trial
application with the U.K. Medicines and Healthcare Products
Regulatory Agency in Q2 20222.
- Granted a Schedule I manufacturing license from the U.S. Drug
Enforcement Agency for the Company's Boston-area research lab that
is expected to allow the Company to expand its internal research
and development capabilities.
- Received approval from the FDA for its IND application to
proceed with a Company-sponsored feasibility study using the Kernel
Flow quantitative neuroimaging technology to measure ketamine's
psychedelic effect on cerebral cortex hemodynamics.
- Launched the EMBARK Psychedelic Facilitator Training Program in
collaboration with the University of Washington in preparation for
the first clinical trial of psilocybin-assisted psychotherapy to
address COVID-19 related distress in frontline healthcare
- Welcomed Dr. Amir Inamdar as Chief Medical Officer for European
Operations; Dr. Geoff Varty as Head of Research and Development;
and Leah Gibson as Vice President of Investor Relations.
Second-Quarter Financial Highlights
- Cash and cash equivalents totaled to C$75.2 million as of
September 30, 2021.
- Net loss was C$17.6 million for the quarter ended September 30,
2021 of which non-cash expenses totaled C$6.0 million and
cash-based operating expenses totaled C$11.6 million.
Conference Call and Webcast Details
The live and archived webcast will also be available on the
Company's Investor Relations site under the Events &
Cybin has decided not to proceed with its nutraceutical product
line in order to focus its efforts on the research and development
of its psychedelic molecules. Further, the Company no longer
anticipates conducting business activities in Jamaica, as the
Company focuses on the new Deuterated Psilocybin Analog Program.
The Company intends to complete future clinical trials in the U.S.
and the U.K.
Cybin is a leading ethical biopharmaceutical company, working
with a network of world-class partners and internationally
recognized scientists, on a mission to create safe and effective
therapeutics for patients to address a multitude of mental health
issues. Headquartered in Canada and founded in 2019, Cybin is
operational in the United States, United Kingdom and Ireland. The
Company is focused on progressing psychedelics to therapeutics by
engineering proprietary drug discovery platforms, innovative drug
delivery systems, novel formulation approaches and treatment
regimens for mental health disorders.
Cautionary Notes and Forward-Looking
Certain statements in this news release related 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 development of innovative drug delivery
systems, statements regarding the potential benefits of the
Company's novel deuterated psilocybin analog, CYB003, statements
regarding the Company's completion of preclinical studies of CYB003
in Q1 20223 and the submission of a new drug
application and clinical trial application in Q2 20224,
statements regarding the Company's EMBARK Psychedelic Facilitator
Training Program, statements regarding the anticipated results of
using Kernel Flow technology in the Company's research, and
statements regarding the expansions of the Company's internal
research and development capabilities under its Schedule I
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 COVID-19
pandemic 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
six month periods ended September 30, 2021, the Company's annua l
information form for the year ended March 31, 2021, and the
Company's listing statement dated November 9, 2020, which are
available under the Company's profile on www.sedar.com 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 or can
diagnose, treat, cure or prevent any disease or condition. Vigorous
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 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.
1 Based on a calendar year-end.
2 Based on a calendar year-end.
3 Based on a calendar year-end.
4 Based on a calendar year-end.
Investor & Media Contact:
Vice President, Investor Relations
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