- Reported positive preclinical data in both its Alzheimer's and dry AMD programs
- Closed Fiscal Q3 with cash position of US$7.9 million
Vancouver, British Columbia–(Newsfile Corp. – May 14, 2024) – InMed Pharmaceuticals Inc. (NASDAQ: INM) ("InMed" or the "Company"), a clinical stage pharmaceutical company focused on developing a pipeline of proprietary small molecule drug candidates, today announced financial results and business update for the third quarter of the fiscal year 2024, which ended March 31, 2024.
The Company's full financial statements and related MD&A for the third quarter ended March 31, 2024, are available at www.inmedpharma.com, www.sedar.com and at www.sec.gov.
Eric A. Adams, InMed President and CEO, commented, "The third quarter of fiscal year 2024 was another positive quarter for the Company as we continue to make exciting progress in our pharmaceutical pipeline and deliver steady growth in our commercial business. Last month we announced important updates in our two preclinical programs in the treatment of Alzheimer's disease ("ALZ") and dry Age-related Macular Degeneration ("dry AMD"). Both programs utilize proprietary small molecule drug candidates activating both the CB1 / CB2 receptors as well as other disease-relevant receptors. We are highly encouraged by the positive findings and we are committed to further advancing our research in these two highly underserved indications."
Adams continued, "Revenues from the BayMedica commercial business remain consistent with the previous quarter and BayMedica operated as a profitable commercial business unit in the current quarter. We remain optimistic for the sector as more brands start to incorporate rare cannabinoids into their product portfolios."
Business update
Pharmaceutical Development Programs
INM-901: A multipronged approach in treatment of Alzheimer's disease.
INM-901 is a proprietary small molecule drug candidate being developed as a potential treatment for ALZ employing multiple mechanisms of actions. On April 4, 2024, the Company announced additional preclinical data demonstrating INM-901's positive pharmacological effects. Results included:
- INM-901 is a preferential signaling agonist of the CB1/CB2 receptors and impacts the PPAR signaling pathway;
- INM-901 demonstrates reduced neuroinflammation and improved neuronal function; and
- mRNA data from INM-901 preclinical studies support the observations made in the previously released behavior studies in locomotor activity, cognition and memory.
InMed continues to accelerate the development of its ALZ program, with long-term behavioural and mechanism of action / receptor interaction studies currently underway. Data read-out expected in calendar 3Q 2024.
Additionally, the Company recently announced the addition of Dr. David G. Morgan, a leader in neurodegenerative disease, to its Scientific Advisory Board ("SAB"), reinforcing the Company's commitment to advancing it's INM-901 program.
INM-089: Neuroprotection in the treatment of dry AMD
INM-089 is another proprietary small molecule drug candidate being studied in the treatment of Age-related Macular Degeneration ("AMD"). In April, the Company announced additional preclinical data for INM-089 further demonstrating positive pharmacological effects. Results from INM-089 preclinical studies included:
- Data indicates that INM-089 may be more effective as a therapeutic treatment for dry AMD compared to neovascular, or wet, AMD;
- More specifically, data suggests INM-089 may be an important candidate for geographic atrophy ("GA") which is common in more advanced cases of dry AMD;
- Enhanced neuroprotection of photoreceptors as well as improved photoreceptor function;
- Improved integrity of retinal pigment epithelium; and
- Reduction in extracellular autofluorescent deposits, a hallmark of dry AMD.
The Company has strategically prioritized the utilization of its proprietary small molecule drug candidates in its drug development initiatives, resulting in the INM-089 program for the treatment of dry AMD taking precedence over the INM-088 program in the treatment of glaucoma. Therefore, the Company will not be advancing INM-088 in the immediate future. Notably, the initial research and data from the INM-088 program have played an instrumental role in shaping the development of INM-089 program.
BayMedica Commercial Business
BayMedica revenues were $3.3 million for the nine months ended March 31, 2024, compared with $1.8 million for the nine months ended March 31, 2023, representing 83% growth over the same period last year. Quarter over quarter revenue has remained flat this period with sales of $1.2 million, same as the previous quarter. BayMedica operated as a profitable business unit this quarter and continues to make progress lowering manufacturing costs that should incrementally improve margins over time. While we are optimistic about the long-term growth potential in the rare cannabinoids sector, we expect revenue to fluctuate in future quarters.
Financial and Corporate Highlights:
- Net loss was $5.7 million for the quarter ended March 31, 2024, compared to a net loss of $7.6 million in the same period last year.
- Research and development and patents expenses were $2.6 million for the nine months ended March 31, 2024, compared with $3.1 million for the nine months ended March 31, 2023.
- General and administrative expenses were $4 million for the nine months ended March 31, 2024, compared with $4.4 million for the same period last year.
- As of March 31, 2023, the Company's cash, cash equivalents and short-term investments were $7.6 million, which compares to $8.9 million on June 30, 2023.
Based on current forecasts, the Company expects its cash will be sufficient to fund its planned operating expenses and capital expenditure requirements into the fourth 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 expenses.
Ms. Alexandra D.J. Mancini, Senior Vice President, Clinical & Regulatory Affairs, provided notice to the Company and the Company's Board of Directors of her intention to retire from her position, effective June 30, 2024. Ms. Mancini intends to continue in a consultancy capacity to ensure a smooth transition of both the INM-755 program and ongoing regulatory matters. The Company would like to thank Ms. Mancini for her significant, valuable contributions, and leadership during her tenure with InMed and wish her all the best in her retirement. We congratulate her on a tremendous career in the biotech industry, having played an important role in developing and bringing to market several pharmaceutical products in many disease areas.
Table 1. InMed Pharmaceuticals Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
Expressed in U.S. Dollars
| March 31, | ||||||||
| 2024 | June 30, | |||||||
| (unaudited) | 2023 | |||||||
| $ | $ | |||||||
| ASSETS | ||||||||
| Current | ||||||||
| Cash and cash equivalents | 7,600,598 | 8,912,517 | ||||||
| Short-term investments | 43,085 | 44,422 | ||||||
| Accounts receivable, net of allowance for credit losses of $66,775 in 2024 and 2023 | 207,681 | 260,399 | ||||||
| Inventories | 1,193,952 | 1,616,356 | ||||||
| Prepaids and other current assets | 1,018,686 | 498,033 | ||||||
| Total current assets | 10,064,002 | 11,331,727 | ||||||
| Non-Current | ||||||||
| Property, equipment and ROU assets, net | 1,370,969 | 723,426 | ||||||
| Intangible assets, net | 1,823,745 | 1,946,279 | ||||||
| Other assets | 100,000 | 104,908 | ||||||
| Total Assets | 13,358,716 | 14,106,340 | ||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| Current | ||||||||
| Accounts payable and accrued liabilities | 1,183,285 | 1,608,735 | ||||||
| Current portion of lease obligations | 345,545 | 375,713 | ||||||
| Deferred rent | – | 16,171 | ||||||
| Total current liabilities | 1,528,830 | 2,000,619 | ||||||
| Non-current | ||||||||
| Lease obligations, net of current portion | 725,236 | 15,994 | ||||||
| Total Liabilities | 2,254,066 | 2,016,613 | ||||||
| Commitments and Contingencies | ||||||||
| Shareholders' Equity | ||||||||
| Common shares, no par value, unlimited authorized shares: | ||||||||
| 6,344,970 (June 30, 2023 – 3,328,191) issued and outstanding | 80,606,863 | 77,620,252 | ||||||
| Additional paid-in capital | 37,507,306 | 35,741,115 | ||||||
| Accumulated deficit | (107,138,088) | (101,400,209) | ||||||
| Accumulated other comprehensive income | 128,569 | 128,569 | ||||||
| Total Shareholders' Equity | 11,104,650 | 12,089,727 | ||||||
| Total Liabilities and Shareholders' Equity | 13,358,716 | 14,106,340 | ||||||
| Related Party Transactions | ||||||||
| Subsequent Events | ||||||||
Table 2. InMed Pharmaceuticals Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
Expressed in U.S. Dollars
| For the Three Months Ended | For the Nine Months Ended | |||||||||||
| 31-Mar | 31-Mar | |||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| $ | $ | $ | $ | |||||||||
| Sales | 1,172,601 | 1,033,925 | 3,314,663 | 1,824,496 | ||||||||
| Cost of sales | 883,143 | 841,414 | 2,416,417 | 1,415,068 | ||||||||
| Inventory write-down | – | – | 263,404 | 576,772 | ||||||||
| Gross profit | 289,458 | 192,511 | 634,842 | (167,344) | ||||||||
| Operating Expenses | ||||||||||||
| Research and development and patents | 656,764 | 878,303 | 2,558,648 | 3,108,312 | ||||||||
| General and administrative | 1,374,095 | 1,412,727 | 4,036,784 | 4,438,083 | ||||||||
| Amortization and depreciation | 54,767 | 50,689 | 164,833 | 148,786 | ||||||||
| Foreign exchange loss | 48,156 | 2,733 | 36,717 | 79,287 | ||||||||
| Total operating expenses | 2,133,782 | 2,344,452 | 6,796,982 | 7,774,468 | ||||||||
| Other Income (Expense) | ||||||||||||
| Interest and other income | 121,458 | 155,497 | 424,261 | 343,881 | ||||||||
| Loss before income taxes | (1,722,866) | (1,996,444) | (5,737,879) | (7,597,931) | ||||||||
| Tax expense | – | (1,500) | – | (11,300) | ||||||||
| Net loss for the period | (1,722,866) | (1,997,944) | (5,737,879) | (7,609,231) | ||||||||
| Net loss per share for the period | ||||||||||||
| Basic and diluted | (0.18) | (0.60) | (0.82) | (3.53) | ||||||||
| Weighted average outstanding common shares | ||||||||||||
| Basic and diluted | 9,612,973 | 3,328,191 | 6,961,938 | 2,156,283 | ||||||||
Table 3. InMed Pharmaceuticals Inc.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited)
Expressed in U.S. Dollars
| March 31, | March 31, | ||||||
| 2024 | 2023 | ||||||
| $ | $ | ||||||
| Cash provided by (used in): | |||||||
| Operating Activities | |||||||
| Net loss | (5,737,879) | (7,609,231) | |||||
| Items not requiring cash: | |||||||
| Amortization and depreciation | 164,833 | 148,786 | |||||
| Share-based compensation | 98,760 | 237,675 | |||||
| Amortization of right-of-use assets | 287,824 | 296,239 | |||||
| Interest income on short-term investments | (1,271) | (392) | |||||
| Unrealized foreign exchange loss | 2,607 | 2,138 | |||||
| Inventory write-down | 263,404 | 576,772 | |||||
| Bad debts | – | 25,085 | |||||
| Changes in operating assets and liabilities: | |||||||
| Inventories | 159,000 | 584,151 | |||||
| Prepaids and other current assets | (520,653) | 102,022 | |||||
| Other non-current assets | 4,908 | 5,507 | |||||
| Accounts receivable | 52,718 | (107,357) | |||||
| Accounts payable and accrued liabilities | (425,446) | (585,341) | |||||
| Deferred rent | (16,171) | 16,171 | |||||
| Lease obligations | (289,302) | (317,490) | |||||
| Total cash used in operating activities | (5,956,668) | (6,625,265) | |||||
| Investing Activities | |||||||
| Payment of acquisition consideration | – | (500,000) | |||||
| Sale of short-term investments | 42,513 | – | |||||
| Purchase of short-term investments | (42,513) | – | |||||
| Purchase of property and equipment | (9,293) | (128198) | |||||
| Total cash used in investing activities | (9,293) | (628,198) | |||||
| Financing Activities | |||||||
| Proceeds from private placement | 4,654,042 | 10,680,654 | |||||
| Total cash provided by financing activities | 4,654,042 | 10,680,654 | |||||
| (Decrease) increase in cash and cash equivalents during the period | (1,311,919) | 3,427,191 | |||||
| Cash and cash equivalents beginning of the period | 8,912,517 | 6,176,866 | |||||
| Cash and cash equivalents end of the period | 7,600,598 | 9,604,057 | |||||
| SUPPLEMENTARY CASH FLOW INFORMATION: | |||||||
| Cash Paid During the Year for: | |||||||
| Income taxes | $ | – | $ | 11,300 | |||
| Interest | $ | – | $ | – | |||
| SUPPLEMENTARY DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | |||||||
| Fair value of warrant modification recorded as equity issuance costs | $ | 3,508,749 | $ | – | |||
| Preferred investment options to its placement agent | $ | 325,699 | $ | 691,483 | |||
| Recognition of Right-of-use asset and corresponding operating lease liability | $ | 968,376 | $ | – | |||
About InMed:
InMed Pharmaceuticals is a clinical stage pharmaceutical company focused on developing a pipeline of proprietary small molecule drug candidates targeting the CB1/CB2 receptors. InMed's pipeline consists of three separate programs in the treatment of Alzheimer's, ocular and dermatological indications. Together with its subsidiary BayMedica, we are a global leader in the manufacturing, development and commercialization of rare cannabinoids and proprietary cannabinoid analogs. For more information, visit www.inmedpharma.com.
Investor Contact:
Colin Clancy
Vice President, Investor Relations
and Corporate Communications
T: +1 604 416 0999
E: [email protected]
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 statements are frequently, but not always, identified by words such as "expects", "anticipates", "believes", "intends", "potential", "possible", "would" and similar expressions. Such statements, based as they are on current expectations of management, inherently involve numerous risks, uncertainties and assumptions, known and unknown, many of which are beyond our control. 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. Without limiting the foregoing, forward-looking information in this news release includes, but is not limited to, statements about: the efficacy of INM-901, INM-901's ability to treat Alzheimer's, marketability and uses for INM-901, the results of further studies into INM-901 and acceleration of the development of InMed's Alzheimer's program; the efficacy of INM-089, INM-089's ability to treat AMD, marketability and uses for INM-089, the results of further studies into INM-089 and the further development of InMed's AMD program; being optimistic about the long-term growth potential in the rare cannabinoids sector; improving margins over time; expectations that the Company's cash will be sufficient to fund its planned operating expenses and capital expenditure requirements into the fourth quarter of calendar year 2024.
Additionally, there are known and unknown risk factors which could cause InMed's actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information contained herein. A complete discussion of the risks and uncertainties facing InMed's stand-alone business is disclosed in InMed's Annual Report on Form 10-K and other filings with the Securities and Exchange Commission on www.sec.gov.
All forward-looking information herein is qualified in its entirety by this cautionary statement, and InMed disclaims any obligation to revise or update any such forward-looking information or to publicly announce the result of any revisions to any of the forward-looking information contained herein to reflect future results, events or developments, except as required by law.
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