Full Press Release Details
Pharmaceuticals Reports Full Year Fiscal 2022 Financial Results
and Provides Business Update
BC - September 23, 2022 - InMed Pharmaceuticals Inc. ("InMed" or the "Company") (Nasdaq: INM),
a leader in the pharmaceutical research, development and manufacturing of rare cannabinoids and cannabinoid analogs, today reported financial
results for the fiscal year ended June 30, 2022.
September 23, 2022, at 10:00 AM Pacific Time, 01:00 PM Eastern Time Registration Link: https://register.vevent.com/register/BIa76ceda464264b3cae0b5ddb6e76a511
Webcast Link: https://edge.media-server.com/mmc/p/cnawzqhu (Webcast replay available for 12 months)
access the call by phone, please go to the registration link and you will be provided with dial in details. To avoid delays, we encourage
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Company's full financial statements and related MD&A for the fiscal year ended June 30, 2022, will be available at www.inmedpharma.com
and at www.sedar.com.
A. Adams, InMed CEO, states, "In the final quarter of our fiscal 2022, as well as throughout the previous fiscal year, we have
made important advancements in our pharmaceutical drug development programs, including expanding our Phase 2 clinical trial for the treatment
of symptoms related to epidermolysis bullosa to include adolescents, and initiating a research collaboration agreement to further screen
cannabinoid analogs for potential therapeutic uses. As announced on September 8, 2022, we have made the decision reduce the efforts of
our subsidiary, BayMedica, to pursue commercialization of rare cannabinoids in the health & wellness sector. Moving forward, the
Company is realigning its focus and resources towards advancing our pharmaceutical drug development programs with the aim of achieving
important milestones in the coming quarters and year."
Development Programs
for the treatment of Epidermolysis Bullosa ("EB")
and patient treatment in the Company's Phase 2 clinical trial, 755-201-EB, continued throughout the fourth quarter and, to date,
nine patients been enrolled and completed treatment in the study. The 755-201-EB study is designed to enroll up to 20 patients. InMed
is evaluating the safety of INM-755 (cannabinol) cream and its preliminary efficacy in treating symptoms and wound healing over a 28-day
treatment period. This study marks the first time cannabinol ("CBN") has advanced to a Phase 2 clinical trial to be investigated
as a therapeutic option to treat a disease.
the fiscal fourth quarter, based on the safety data of the first five adult patients who completed treatment with INM-755 CBN cream for
the treatment of EB in the Phase 2 clinical trial, an independent Data Monitoring Committee ("DMC") agreed it is safe to
allow the enrollment of adolescent patients, defined as persons aged twelve to seventeen. The first adolescent patient with EB has been
enrolled into the clinical trial and has completed treatment at the clinical site in Greece during the summer.
a period of downtime during the summer months, patient screening and enrollment has now recommenced at sites across Europe. The Company
anticipates that the inclusion of adolescents will have a positive impact on the enrollment rate for the remainder of the clinical trial.
Enrollment is anticipated to complete during the calendar year 2022.
Phase 2 clinical trial now has nine clinical trial sites fully activated to screen and enroll patients. Two more sites are expected to
be fully activated soon. The clinical trial is taking place in seven countries including Austria, Germany, Greece, France, Italy, Israel
for the treatment of glaucoma
the fourth fiscal quarter, the Company completed a pre-Investigational New Drug ("pIND") application discussion with the
U.S. Food and Drug Administration ("FDA") regarding manufacturing, preclinical studies and early clinical development plans
for INM-088, a CBN formulation in development for glaucoma. The Company gained alignment with FDA on the design of the initial Phase
1-2 clinical trial to gather preliminary data on the safety and efficacy of INM-088 treatment. Management expects to file regulatory
applications in the first half of the calendar year 2024 to initiate a human clinical trial.
referenced in a recent international journal publication [Biochimica et Biophysical Acta
(BBA) - Molecular Basis of Disease, Volume 1868, Issue 3, 1 March 2022, 166325], InMed's preclinical research demonstrates
that CBN is effective at providing neuroprotection to the retinal ganglion cells and reducing intraocular pressure in glaucoma models,
and outperformed several other naturally occurring cannabinoids, including tetrahydrocannabinol ("THC").
cannabinoid analogs and other R&D programs
the research and development of cannabinoid analogs remains a high priority for the Company. In April 2022, the Company announced the
publication of a patent application in North America for several cannabinoid analogs. This patent application, covering potentially hundreds
of new chemical entities, has broad claims directed to their molecular structure, therapeutic uses and methods of manufacturing.
addition, the Company also initiated a research collaboration agreement with the Department of Biotechnological and Applied Clinical
Sciences, University of L'Aquila (Italy) in the laboratory of Dr. Mauro Maccarrone. Dr. Maccarrone's lab will be screening
the Company's novel cannabinoid analogs to investigate pharmacological properties and potential therapeutic uses.
April, BayMedica announced it will be providing rare cannabinoids for use in Radicle Science, Inc.'s Radicle Energy rare cannabinoid
study to assess the effects of delta-9 ("d-9") dominant tetrahydrocannabivarin ("THCV") on energy, focus/attention,
appetite and weight/BMI. BayMedia is supplying its highly pure d-9 dominant THCV, formulated into a proprietary lozenge manufactured
by Trokie. The Study has been ongoing throughout the summer and results are expected in October 2022.
Company continues to advance discovery work for the potential use of cannabinoid analogs to improve neuronal function and provide neuroprotection
for treating neurodegenerative disorders such as Alzheimer's disease, Parkinson's disease and Huntington's disease.
To date, screening for this indication has yielded interesting analog candidates and the Company will continue to proceed with its plan
to find an appropriate compound for a preclinical development program.
commercial activities
previously announced on September 8, 2022, the Company will be reducing its focus on the BayMedica commercial business targeted to the
health & wellness sector. BayMedica will continue to explore potential opportunities for structured supply agreements, commercial
collaborations and review other strategic alternatives for the commercial aspect of its business. The research and development activities
focused on the generation of proprietary cannabinoid analogs to support the Company's pharmaceutical drug development programs
will continue at BayMedica.
to fiscal year end, Michael Woudenberg was appointed Chief Operating Officer of the Company, overseeing all day-to-day operations. Mr.
Woudenberg was previously Senior Vice President of Chemistry, Manufacturing and Controls and has been an integral part of the executive
team for the last four years, supporting multiple functions within the organization.
the second half of fiscal 2022 and during the subsequent months, InMed and its BayMedica subsidiary implemented significant cost saving
measures, including some personnel changes. These initiatives included a reduction in total headcount and voluntary salary reductions
for several members of management. These changes have resulted in a reduction by approximately 25% of the current workforce. This reduction
in headcount, along with other cost reduction initiatives, is expected to result in human resource expense savings of approximately 30%
on an annualized basis. As part of these reductions, InMed President and CEO Eric A. Adams volunteered a 28% reduction in salary as compared
to the previous year. Also, as part of these expense reduction initiatives, no employee received an annual performance bonus for fiscal
with ongoing cost saving initiatives, in the fourth quarter and subsequent months, the Company successfully conducted a series of financing
events to further capitalize the Company and its ongoing development programs. In June 2022, the Company closed a registered direct offering
and concurrent private placement for total proceeds of approximately $5 million. In August 2022, the Company announced a share consolidation
of 1:25 in order to regain compliance with Nasdaq's continued listing requirements and subsequently received notification of compliance
on September 21, 2022 from the exchange. Most recently, on September 13, 2022, the Company closed an additional $6 million private placement
with two healthcare-focused institutional investors.
and Operational Highlights:
the year ended June 30, 2022, the Company recorded a net loss of $18.6 million, or $33.17 per share, compared with a net loss of $10.2
million or $37.96 per share, for the previous year.
and development and patents expenses were $7.3 million for year ended June 30, 2022, compared with $5.3 million for the year ended June
30, 2021. The increase in research and development and patents expenses was due to the inclusion of BayMedica operating results following
the acquisition date and due to increased activities related to the INM-755 Phase 2 clinical trial.
Company incurred general and administrative expenses of $6.9 million for the year ended June 30, 2022, representing a 54% increase on
the previous year. The increase is due to the inclusion of BayMedica operating results following the acquisition date, a combination
of changes including investor relations expenses, accounting fees and legal fees and substantially higher insurance fees resulting from
our listing on the Nasdaq capital market.
Company realized sales of $1.1 million in our BayMedica segment for the year ended June 30, 2022, the result of the manufacturing and
sale of bulk rare cannabinoid products following the acquisition of BayMedica in October 2021. As the year ended June 30, 2021 predated
the acquisition of BayMedica, there are no comparable revenues in 2021.
of June 30, 2022, the Company's cash, cash equivalents and short-term investments were $6.2 million. Subsequent to the recent financing
on September 13, 2022, the Company has a current cash position of approximately $10 million. Based on the current forecast, which is
subject to potential revisions in the future, the Company's current cash reserves are estimated to last into the second half of
fiscal 2023, and possibly into the first quarter of fiscal 2024, (being the third calendar quarter of 2023), depending on the level and
timing of realizing revenues from the sale of BayMedica inventory as well as the level and timing of the Company operating expenses.
a result of the decision to refocus on its core business in the pharmaceutical drug development area and reduce efforts in BayMedica's
commercial business, the Company incurred a non- cash impairment of intangible assets and goodwill of $3.5 million in the BayMedica segment