Full Press Release Details
| NASDAQ: INM | |
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| www.inmedpharma.com |
InMed Reports First Quarter Fiscal 2024 Financial
Results and Provides Business Update
November 14, 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 reports financial results for the first quarter of the fiscal year 2024 which ended September 30, 2023.
full financial statements and related MD&A for the first quarter ended September 30, 2023, are available
Eric A. Adams, InMed
Chief Executive Officer, commented, "We are pleased with the continued advancements across our pharmaceutical programs and commercial
operations. We are particularly excited with the recent candidate selection and official launch of our INM-901 preclinical program targeting
the treatment of Alzheimer's disease, representing a unique and innovative treatment approach compared to current options available
to patients. Our commercial subsidiary, BayMedica, continues to make steady progress as a B2B supplier of rare cannabinoids to the Health
and Wellness sector as our trailing 12-month sales trend continues to show steady growth."
Adams continued, "Furthermore,
the successful completion of a recent financing further strengthens our balance sheet and provides additional financial stability in a
particularly challenging capital markets environment. These additional funds extend our cash runway into calendar 3Q 2024."
Pharmaceutical Development
Neurodegenerative Diseases Program INM-901:
Demonstrates unique pharmacological effects in Alzheimer's disease
On October 24, 2023,
the Company announced it has selected a lead Alzheimer's disease drug candidate, named INM-901, following positive results from
several proof-of-concept studies in a validated Alzheimer's disease treatment model. InMed will be advancing INM-901, a cannabinoid
analog, in its pharmaceutical drug development program. Based on early in vitro research, INM-901 showed potential to
target several biological pathways associated with Alzheimer's, including neuroprotection to the brain neurons from beta-amyloid
peptide-induced toxicity and targeting neuronal function improvement via extension of neurite length. In addition to these encouraging in
vitro testing outcomes, INM-901 demonstrated favorable results in an in vivo preclinical Alzheimer's proof-of-concept
model. When compared to the placebo treated Alzheimer's disease group in these preclinical studies, INM-901 treatment groups demonstrated
a trend towards improvement in cognitive function and memory, locomotor activity, anxiety-based behavior and sound awareness.
Next stages of advanced
preclinical studies are underway which will include drug distribution, metabolism (elimination of the drug from the body), pharmacokinetics
(how the body interacts with the administered drug) and continuation of pharmaceutical drug development activities such as manufacturing
INM-755: Assessing potential partnership opportunities
In the calendar 2Q 2023,
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. The data showed a positive indication of enhanced anti-itch activity for INM-755 cannabinol cream
versus the control cream alone. 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. The Company
continues to assess potential partnership opportunities for the advancement of INM-755.
The Company recently
gave an oral presentation of an abstract describing the Phase 2 clinical study of investigational drug INM-755 CBN cream for the treatment
of symptoms in patients with epidermolysis bullosa ("EB"), a rare genetic skin disease, at the 12th World Congress on
Itch (WCI), held in Miami on November 5-7, 2023. A copy of the poster and other presentation materials will be made available on the Company's website.
Full data and results
of the Phase 2 clinical trial will be published shortly in Itch, the official journal of the International Forum
for the Study of Itch (IFSI).
BayMedica Commercial
BayMedica, a leading supplier of non-intoxicating
rare cannabinoids to the health and wellness sector, continues to experience robust year-over-year revenue growth. BayMedica had sales
of $0.90M for the three months ended September 30, 2023, representing a 181% increase over the same quarter in the previous year. While
sales increased year-over-year, there was a decrease in revenue of 61% from the previous quarter. The changes in revenue can be attributed
mainly to distributor order patterns and product mix, which may lead to occasional quarter-over-quarter decreases. However, we anticipate
sustained growth as the market expands and brands continue to innovate by incorporating new cannabinoid ingredients in their product mix.
The Company continues to make progress lowering
manufacturing costs that should improve margins over time. Additionally, the Company will continue to maintain a strategic focus on aligning
production and inventory levels with sales demand and estimated forecasts.
BayMedica will have a booth at the upcoming MJBiz
Conference in Las Vegas from November 28th to December 1st, 2023. Representatives of both InMed and BayMedica will
be on site to meet with both distributors and end product manufactures of Health and Wellness products containing rare cannabinoids.
Financial commentary
For the three months ended September 30, 202,
the Company recorded a net loss of $2.5M compared with a net loss of $3.5M for the three months ended September 30, 2022.
Research and development and patents expenses
were $1.3M for the three months ended September 30, 2023, compared with $1.4M for the three months ended September 30, 2022. The decrease
in research and development and patents expenses was due to a combination of lower research supplies expense and decreased activities
related to the INM-755 Phase 2 clinical trials. We expect research and development expenses to increase in calendar year 2024 as the Company
advances preclinical work in INM-901 and IND enabling studies in ocular disease.
The Company incurred general and administrative
expenses of $1.3M for the three months ended September 30, 2023, compared to $1.6M in the three months ended September 30, 2022. The decrease
was primarily from a combination of changes in the InMed segment, including lower office and admin fees, accounting and legal fees, stock-based
compensation expenses, regulatory fees and consulting fees.
At September 30, 2023, the Company's cash,
cash equivalents and short-term investments were $6.7 million, which compares to $8.9 million at June 30, 2022. Subsequent to the quarter's
close, on October 26, 2023, the Company closed a $5.2 million financing. The Company continues to closely monitor expenses while advancing
its pharmaceutical pipeline candidates. Based on current forecasts, the Company expects its cash will be sufficient to fund its planned
operating expenses and capital expenditure requirements into the third quarter of calendar year 2024, depending on the level and timing
of realizing BayMedica revenues from the sale of products in the Health & Wellness sector as well as the level and timing of our operating
CONDENSED CONSOLIDATED INTERIM BALANCE SHEETS
Expressed in U.S. Dollars
| Note | September 30, 2023 (unaudited) | June 30, 2023 | ||||||||||
| $ | $ | |||||||||||
| ASSETS | ||||||||||||
| Current | ||||||||||||
| Cash and cash equivalents | 6,738,304 | 8,912,517 | ||||||||||
| Short-term investments | 11 | 42,942 | 44,422 | |||||||||
| Accounts receivable, net | 165,850 | 260,399 | ||||||||||
| Inventories | 3 | 1,133,097 | 1,616,356 | |||||||||
| Prepaids and other current assets | 215,015 | 498,033 | ||||||||||
| Total current assets | 8,295,208 | 11,331,727 | ||||||||||
| Non-Current | ||||||||||||
| Property, equipment and ROU assets, net | 4 | 615,055 | 723,426 | |||||||||
| Intangible assets, net | 5 | 1,905,286 | 1,946,279 | |||||||||
| Other assets | 101,790 | 104,908 | ||||||||||
| Total Assets | 10,917,339 | 14,106,340 | ||||||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||||||
| Current | ||||||||||||
| Accounts payable and accrued liabilities | 6 | 1,046,251 | 1,608,735 | |||||||||
| Current portion of lease obligations | 9 | 292,998 | 375,713 | |||||||||
| Deferred rent | - | 16,171 | ||||||||||
| Total current liabilities | 1,339,249 | 2,000,619 | ||||||||||
| Non-current | ||||||||||||
| Lease obligations, net of current portion | 9 | - | 15,994 | |||||||||
| Total Liabilities | 1,339,249 | 2,016,613 | ||||||||||
| Commitments and Contingencies (Note 14) | ||||||||||||
| Shareholders' Equity | ||||||||||||
| Common shares, no par value, unlimited authorized shares: 3,328,191 (June 30, 2023 - 3,328,191) issued and outstanding | 7 | 77,620,252 | 77,620,252 | |||||||||
| Additional paid-in capital | 7, 8 | 35,766,306 | 35,741,115 | |||||||||
| Accumulated deficit | (103,937,037 | ) | (101,400,209 | ) | ||||||||
| Accumulated other comprehensive income | 128,569 | 128,569 | ||||||||||
| Total Shareholders' Equity | 9,578,090 | 12,089,727 | ||||||||||
| Total Liabilities and Shareholders' Equity | 10,917,339 | 14,106,340 | ||||||||||
| Related Party Transactions (Note 12) | ||||||||||||
| Subsequent Events (Note 13) |
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS (unaudited)
Expressed in U.S. Dollars
| For the Three Months Ended September 30 | ||||||||||
| Note | 2023 | 2022 | ||||||||
| $ | $ | |||||||||
| Sales | 901,862 | 320,788 | ||||||||
| Cost of sales | 787,690 | 235,034 | ||||||||
| Inventory write-down | 3 | 92,930 | 576,772 | |||||||
| Gross profit | 21,242 | (491,018 | ) | |||||||
| Operating Expenses | ||||||||||
| Research and development and patents | 1,292,093 | 1,378,653 | ||||||||
| General and administrative | 1,298,731 | 1,560,477 | ||||||||
| Amortization and depreciation | 4, 5 | 54,832 | 49,048 | |||||||
| Foreign exchange loss | 48,457 | 96,791 | ||||||||
| Total operating expenses | 2,694,113 | 3,084,969 | ||||||||
| Other Income (Expense) | ||||||||||
| Interest and other income | 136,043 | 72,587 | ||||||||
| Loss before income taxes | (2,536,828 | ) | (3,503,400 | ) | ||||||
| Tax expense | - | (6,800 | ) | |||||||
| Net loss | (2,536,828 | ) | (3,510,200 | ) | ||||||
| Net loss per share | ||||||||||
| Basic and diluted | (0.76 | ) | (4.06 | ) | ||||||
| Weighted average outstanding common shares | ||||||||||
| Basic and diluted | 3,328,191 | 865,619 |
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
For the Three Months ended September 30, 2023 and 2022 (unaudited)
Expressed in U.S. Dollars
| Note | 2023 | 2022 | ||||||||
| $ | $ | |||||||||
| Cash provided by (used in): | ||||||||||
| Operating Activities | ||||||||||
| Net loss | (2,536,828 | ) | (3,510,200 | ) | ||||||
| Items not requiring cash: | ||||||||||
| Amortization and depreciation | 4, 5 | 54,832 | 49,048 | |||||||
| Share-based compensation | 8 | 25,191 | 116,680 | |||||||
| Amortization of right-of-use assets | 94,532 | 99,460 | ||||||||
| Interest income received on short-term investments | (538 | ) | (120 | ) | ||||||
| Unrealized foreign exchange loss | 2,018 | 2,796 | ||||||||
| Inventory write-down | 3 | 92,930 | 576,772 | |||||||
| Changes in operating assets and liabilities: | ||||||||||
| Inventories | 390,329 | 135,559 | ||||||||
| Prepaids and other currents assets | 283,018 | 440,560 | ||||||||
| Other non-current assets | 3,118 | 5,507 | ||||||||
| Accounts receivable | 94,549 | 72,858 | ||||||||
| Accounts payable and accrued liabilities | (562,484 | ) | (159,260 | ) | ||||||
| Deferred rent | (16,171 | ) | - | |||||||
| Deferred revenue | - | 15,700 | ||||||||
| Lease obligations | (98,709 | ) | (100,903 | ) | ||||||
| Total cash used in operating activities | (2,174,213 | ) | (2,255,543 | ) | ||||||
| Investing Activities | ||||||||||
| Sale of short-term investments | 21,317 | - | ||||||||
| Purchase of short-term investments | (21,317 | ) | - | |||||||
| Total cash provided by investing activities | - | - | ||||||||
| Financing Activities | ||||||||||
| Shares issued for cash | - | 6,000,365 | ||||||||
| Share issuance costs | - | (571,261 | ) | |||||||
| Total cash provided by financing activities | - | 5,429,104 | ||||||||
| (Decrease) increase in cash during the period | (2,174,213 | ) | 3,173,561 | |||||||
| Cash and cash equivalents beginning of the period | 8,912,517 | 6,176,866 | ||||||||
| Cash and cash equivalents end of the period | 6,738,304 | 9,350,427 | ||||||||
| SUPPLEMENTARY CASH FLOW INFORMATION: | ||||||||||
| Cash Paid During the Year for: | ||||||||||
| Income taxes | $ | - | $ | 6,800 | ||||||
| Interest | $ | - | $ | - | ||||||
| SUPPLEMENTARY DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||||||||||
| Preferred investment options to its placement agent | $ | - | $ | 547,441 |
InMed Pharmaceuticals is a global leader in the
research, development, manufacturing and commercialization of rare cannabinoids, including clinical and preclinical programs targeting
the treatment of diseases with high unmet medical needs. We also have significant know-how in developing proprietary manufacturing approaches
to produce cannabinoids for various market sectors. For more information, visit www.inmedpharma.com and https://www.baymedica.com/.
Vice President, Investor Relations
and Corporate Communications
Cautionary Note Regarding Forward-Looking Information:
This news release contains
"forward-looking information" and "forward-looking statements" (collectively, "forward-looking information")
within the meaning of applicable securities laws. Forward-looking information is based on management's current expectations and beliefs
and is subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the
forward-looking statements. Forward-looking information in this news release includes statements about: INM-901 represents a unique and