Full Press Release Details
InMed Pharmaceuticals Reports
Full Year Fiscal 2023 Financial Results and Provides Business Update
September 29, 2023 - InMed Pharmaceuticals Inc. ("InMed" or the "Company") (Nasdaq: INM),
a leader in the pharmaceutical research, development, manufacturing and commercialization of rare cannabinoids and cannabinoid analogs,
today announced financial results for the fiscal year ending June 30, 2023 and provided a business update on the pharmaceutical drug development
programs as well as the commercial segment for a wholly-owned subsidiary, BayMedica, LLC ("BayMedica").
full financial statements and related MD&A for the fiscal year ended June 30, 2023, are available at www.inmedpharma.com and
Financial and operating
highlights for fiscal 2023:
Eric A. Adams, InMed
Chief Executive Officer commented, "In fiscal year 2023, the Company's wholly-owned subsidiary, BayMedica, achieved substantial
revenue growth via the supply of rare cannabinoids as ingredients to the health and wellness sector. In the January to June timeframe,
BayMedica experienced substantial growth, as evidenced by two consecutive quarters of significant revenue increases. While we expect some
fluctuations in revenue as ordering patterns in this developing market still mature, we remain optimistic about the long-term growth potential
in the rare cannabinoids sector as the business dynamics and commercial opportunities continue to mature. Additionally, we continue to
advance our pharmaceutical pipeline using rare cannabinoids for potential therapeutic applications in dermatology, ocular and neurodegenerative
Adams continued, "Results
from the Phase 2 clinical trial in the treatment of symptom related to EB demonstrated sufficient clinically important anti-itch activity
to warrant further development. We are now seeking strategic partnership opportunities to further advance INM-755 in EB and other anti-itch
indications with larger commercial opportunities. Progress in both our ocular and neurodegenerative disease programs highlights our commitment
to advancing our pharmaceutical pipeline, with a particular emphasis on advancing our library of proprietary cannabinoid analogs."
Pharmaceutical Development
- Phase 2 Clinical Trial Complete
In the fourth quarter,
we announced safety and efficacy results from the Phase 2 clinical trial, called 755-201-EB (the "Phase 2 Trial"), for the
treatment of symptoms related to EB. Of the 18 participants assessed in this trial, chronic itch improved by a clinically meaningful amount
in 12 patients (66.7%) of whom 5 patients (27.8%) treated with INM-755 showed meaningful anti-itch activity beyond that of the control
cream. Due to several factors, including the small size of the trial and the clinically important anti-itch activity of the underlying
cream without study drug, results were not statistically significant, but we believe the results are clinically important based on additional
analyses. That the majority of the assessed patients in the trial showed clinically meaningful improvement in chronic itch from the application
of INM-755, be it with similar outcomes to the control cream or better than the control cream, can be considered impressive. We are encouraged
by and satisfied with the INM-755 clinical data for chronic itch treatment. The results indicate that continue development as an anti-itch
product is warranted. Please see press release dated June 22, 2023, for full details.
and efficacy data for treating non-wound itch in this EB study, as well as previous safety data from Phase 1 trials, we believe there
is sufficient data to warrant its further development as an anti-itch therapy in patients with EB or other diseases. Further development
of the INM-755 CBN cream is expected to extend beyond its application in EB, potentially encompassing broader indications related to chronic
itch with larger target populations and potential commercial opportunities. InMed has engaged the services of an external business development
consultant to assess potential partnership opportunities for the advancement of INM-755.
- Advancing treatment for both front and back of eye diseases
The Company continued
to advance INM-088 in the treatment of glaucoma, conducting IND-enabling preclinical testing for the development of a CBN-based eye drop
Establishing the role
of certain cannabinoids in neuroprotection of the eye led to the investigation of our proprietary cannabinoid analogs as a potential treatment
for other ocular diseases including Age-Related Macular Degeneration ("AMD"), who's affected populations are much larger
than glaucoma. We are currently screening our library of proprietary analog candidates for continued research and will provide further
updates in the near term.
diseases program - Promising proprietary cannabinoid analogs
In November 2022, InMed
launched the INM-900 series program targeting the use of proprietary cannabinoid analogs to treat neurodegenerative diseases such as Alzheimer's,
Huntington's and Parkinson's. InMed's ocular neuroprotection research led to investigation as to how cannabinoids might
play a role in protecting other neurons in the human body from cell death and potentially impacting different diseases.
Cannabinoids have two
inherent advantages when assessing their potential to treat diseases in the brain. First, they are highly lipophilic compounds (readily
dissolve in fats, oils and lipids) that can effectively cross the blood-brain barrier in meaningful concentrations, which is traditionally
a challenge in drug development. Second, they have proven to be relatively safe compounds in the brain, whereas several currently approved
treatments for neurodegenerative diseases can cause inflammation and bleeding in the brain. InMed's research thus far demonstrates
that certain cannabinoid analogs may inhibit or slow the progression of neurodegenerative diseases by providing neuroprotection in a population
of affected neurons.
identified two cannabinoid analogs (INM-900 series of compounds) demonstrating promising effects related to the treatment of neurodegenerative
diseases. Candidate selection and further preclinical in vivo readout is expected in the near term.
BayMedica Commercial
BayMedica, a leading supplier of non-intoxicating
rare cannabinoids to the health and wellness sector, has experienced strong revenue growth during the fiscal year 2023, reaching $4.1M,
representing a 280% increase over the previous year. Notably, BayMedica has achieved three consecutive quarters of substantial revenue
growth, with Q2, Q3, and Q4 2023 seeing increases of 46%, 100%, and 123%, respectively. While we expect revenue fluctuations based on
distributor order patterns, there are no assurances that this growth will continue in future quarters. However, the recent trend of increased
sales is encouraging. Over the last 12 months, BayMedica has optimized and scaled up manufacturing processes to meet increasing demand, secured
more sources of raw materials as well as secured additional downstream purification partners in order to provide customers with high-purity
rare cannabinoids with minimal batch-to-batch variations.
no assurances this growth will continue in future quarters, this recent trend is encouraging. BayMedica will continue to evaluate opportunities
for potential structured supply arrangements and collaborations for the commercial business. Sales and marketing efforts will remain focused
on products that contribute highest margins, where BayMedica continues to hold a strong competitive position.
Financial commentary:
For the year ended June 30, 2023, the
Company recorded a net loss of $7.9M, or $3.25 per share, compared with a net loss of $18.6M or $33.17 per share, for the previous year.
Research and development and patents expenses
were $3.7M for year ended June 30, 2023, compared with $7.3M for the year ended June 30, 2022. Expenses decreased by $3.1M in our InMed
segment, or 52%, for the year ended June 30, 2023 compared to the year ended June 30, 2022. The decrease in research and development and
patents expenses was due to a combination of lower personnel expenses, legal fees and decreased expenses related to the INM-755 program
as a result of high start-up costs associated with the multicentre Phase 2 clinical trial during fiscal 2022.
The Company incurred general and administrative
expenses of $5.8M for the year ended June 30, 2023, compared to $6.9M in the previous year. The decrease was primarily from a combination
of changes in the InMed segment, including lower office and admin fees, investor relation expenses, stock-based compensation expenses,
personnel expenses, accounting, and legal fees. This was offset by a slight increase in the BayMedica segment.
The Company realized sales of $4.1M
in our BayMedica segment for the year ended June 30, 2023, representing a 280% increase over the previous year. BayMedica realized three
consecutive quarters of significant revenue growth, with increases of 46%, 100%, and 123% in Q2, Q3, and Q4 2023, respectively.
As of June 30, 2023, the Company's
cash, cash equivalents and short-term investments were $9.0M. The Company expects its cash will be sufficient to fund its planned operating
expenses and capital expenditure requirements into the first quarter of calendar year 2024, depending on the level and timing of realizing
BayMedica revenues from the sale of non-intoxicating rare cannabinoids in the health and wellness sector as well as the level and timing
of the Company's operating expenses.
Table 1. Consolidated Balance Sheet
Expressed in U.S. Dollars
| June 30, | June 30, | |||||||
| 2023 | 2022 | |||||||
| ASSETS | $ | $ | ||||||
| Current | ||||||||
| Cash and cash equivalents | 8,912,517 | 6,176,866 | ||||||
| Short-term investments | 44,422 | 44,804 | ||||||
| Accounts receivable, net | 260,399 | 88,027 | ||||||
| Inventories | 1,616,356 | 2,490,854 | ||||||
| Prepaids and other current assets | 498,033 | 797,225 | ||||||
| Total current assets | 11,331,727 | 9,597,776 | ||||||
| Non-Current | ||||||||
| Property, equipment and ROU assets, net | 723,426 | 904,252 | ||||||
| Intangible assets, net | 1,946,279 | 2,108,915 | ||||||
| Other assets | 104,908 | 176,637 | ||||||
| Total Assets | 14,106,340 | 12,787,580 | ||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| Current | ||||||||
| Accounts payable and accrued liabilities | 1,608,735 | 2,415,265 | ||||||
| Current portion of lease obligations | 375,713 | 404,276 | ||||||
| Deferred rent | 16,171 | - | ||||||
| Acquisition consideration payable | - | 500,000 | ||||||
| Total current liabilities | 2,000,619 | 3,319,541 | ||||||
| Non-current | ||||||||
| Lease obligations, net of current portion | 15,994 | 389,498 | ||||||
| Total Liabilities | 2,016,613 | 3,709,039 | ||||||
| Commitments and Contingencies (Note 14) | ||||||||
| Shareholders' Equity | ||||||||
| Common shares, no par value, unlimited authorized shares: 3,328,191 (June 30, 2022 - 650,667) issued and outstanding | 77,620,252 | 70,718,461 | ||||||
| Additional paid-in capital | 35,741,115 | 31,684,098 | ||||||
| Accumulated deficit | (101,400,209 | ) | (93,452,587 | ) | ||||
| Accumulated other comprehensive income | 128,569 | 128,569 | ||||||
| Total Shareholders' Equity | 12,089,727 | 9,078,541 | ||||||
| Total Liabilities and Shareholders' Equity | 14,106,340 | 12,787,580 | ||||||
| Related Party Transactions (Note 15) | ||||||||
| Subsequent Events (Note 16) |
Table 2. Consolidate Statements of Operations
Expressed in U.S. Dollars
| For the Years Ended | ||||||||
| June 30 | ||||||||
| 2023 | 2022 | |||||||
| $ | $ | |||||||
| Sales | 4,135,561 | 1,089,435 | ||||||
| Cost of sales | 2,423,588 | 545,889 | ||||||
| Inventory write-down | 308,937 | - | ||||||
| Gross profit | 1,403,036 | 543,546 | ||||||
| Operating Expenses | ||||||||
| Research and development and patents | 3,732,056 | 7,282,615 | ||||||
| General and administrative | 5,847,518 | 6,867,030 | ||||||
| Amortization and depreciation | 202,249 | 185,657 | ||||||
| Impairment of intangible assets and goodwill | - | 3,472,593 | ||||||
| Total operating expenses | 9,781,823 | 17,807,895 | ||||||
| Other Income (Expense) | ||||||||
| Interest and other income | 492,440 | 96,090 | ||||||
| Warrant modification expense | - | (1,314,307 | ) | |||||
| Foreign exchange loss | (48,175 | ) | (117,551 | ) | ||||
| Loss before income tax expense | (7,934,522 | ) | (18,600,117 | ) | ||||
| Income tax expense | (13,100 | ) | - | |||||
| Net loss for the year | (7,947,622 | ) | (18,600,117 | ) | ||||
| Net loss per share for the year | ||||||||
| Basic and diluted | (3.25 | ) | (33.17 | ) | ||||
| Weighted average outstanding common shares | ||||||||
| Basic and diluted | 2,448,458 | 560,829 |
Table 3. Consolidated Statements of CashFlows
Expressed in U.S. Dollars