EX-99.1 2 ea021615001ex99-1_inmed.htm NEWS RELEASE, DATED SEPTEMBER 30, 2024

Exhibit 99.1

 

NASDAQ: INM

 

InMed Pharmaceuticals Reports Full Year Fiscal 2024 Financial Results and Provides Business Update

 

Advances INM-901 program targeting several biological pathways associated with Alzheimer’s disease

 

Further develops INM-089 demonstrating neuroprotection in the treatment of dry Age-related Macular Degeneration

 

$4.6M revenues in fiscal year 2024, representing a 11% increase over the previous fiscal year

 

Vancouver, BC – September 30, 2024 – InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (Nasdaq: INM), a pharmaceutical company focused on developing a pipeline of proprietary small molecule drug candidates for diseases with high unmet medical needs, today announced financial results for the fiscal year ending June 30, 2024 and provided a business update on the pharmaceutical drug development programs as well as the commercial segment for its wholly-owned subsidiary, BayMedica, LLC (“BayMedica”).

 

The Company’s full financial statements and related MD&A for the fiscal year ended June 30, 2024, are available at www.inmedpharma.com and at www.sedar.com.

 

Financial and operating highlights for fiscal 2024:

 

As of June 30, 2024, the Company’s cash, cash equivalents and short-term investments were $6.6M

 

For the year ended June 30, 2024, the Company recorded a net loss of $7.7M, compared with a net loss of $7.9M for the previous year

 

Advanced INM-901 program with long-term preclinical studies, targeting multiple mechanisms of action in the treatment of Alzheimer’s disease

 

Launched INM-089 preclinical program in the treatment of Age-Related Macular Degeneration (“AMD”) and reported preclinical data demonstrating positive pharmacological effects

 

Strengthened patent portfolio with the issuance of three new U.S. patents across formulation and method of use, manufacturing and drug delivery formulation

 

Total sales for BayMedica were $4.6M in fiscal year 2024, representing an 11% increase over the previous fiscal year

 

Eric A. Adams, InMed Chief Executive Officer commented, “In fiscal year 2024, we made significant progress in our pharmaceutical pipeline, advancing two preclinical programs targeting Alzheimer’s disease and dry AMD. Both these programs utilize proprietary small molecule drug candidates that activate both the CB1 and CB2 receptors, as well as other disease-relevant receptors. We are especially encouraged by the rapid advancement of the INM-901 program, which has been in development for less than a year since the drug candidate was selected last October.”

 

 

 

 

The Alzheimer’s treatment landscape has shifted significantly in recent years, underscoring the need for innovative, disease-modifying therapies and more convenient treatment options. Industry leaders now recognize that treating a complex disease like Alzheimer’s will likely require a combination of therapies or a multi-faceted approach. With INM-901, InMed has developed an orally available small molecule that has demonstrated disease-modifying effects in preclinical studies by targeting multiple biological pathways, positioning us at the forefront of innovative Alzheimer’s research.”

 

Business Update

 

Pharmaceutical Development Programs

 

INM-901: Targeting several biological pathways associated with Alzheimer’s disease

 

INM-901 is a proprietary small molecule drug candidate with multiple mechanisms of action in development as a potential treatment for Alzheimer’s disease. Throughout fiscal 2024, the Company announced several key findings for INM-901:

 

A preferential signaling agonist of the CB1/CB2 receptors and has been shown to have neuroprotective effects, helping protect the neurons in the brain from damage and cell death

 

Impacts the peroxisome proliferator-activated receptors (“PPARs”), which have been shown to play an important role in diabetes and are also considered as one of the potential therapeutic targets for neurodegenerative disorders such as Alzheimer’s disease.

 

Demonstrates reduced neuroinflammation and improved neurite growth and neuronal function, indicating the potential to restore damage caused by Alzheimer’s disease.

 

Can be administered orally and achieve therapeutic levels in the brain comparable to those obtained through intraperitoneal (“IP”) injection, offering many potential advantages over routes of administration of the currently approved products; and

 

Demonstrates significant improvement in cognitive function, memory, locomotor activity, anxiety-based behavior and sound awareness in long term preclinical behavioural studies

 

InMed continues to accelerate the development of its Alzheimer’s program, with additional molecular analysis of a preclinical long-term dosing study currently underway to better define the mechanisms of action. Data read-out is expected in the coming months. Additionally, the development of the chemistry, manufacturing, and controls (“CMC”) for both the drug substance and the drug product formulation is ongoing, with GLP studies in the planning stages to support an IND submission.

 

INM-089: Neuroprotection in the treatment of dry AMD

 

INM-089 is a proprietary small molecule drug candidate being studied in the treatment of dry AMD. Throughout fiscal 2024, the Company reported preclinical data for INM-089 demonstrating positive pharmacological effects including.

 

Data indicates that INM-089 may be more effective as a therapeutic treatment for dry AMD compared to neovascular, or wet, AMD

 

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More specifically, data suggests INM-089 may be an important candidate for geographic atrophy (“GA”) which is a more advanced stage of dry AMD

 

Enhanced neuroprotection of photoreceptors as well as improved photoreceptor function

 

Improved integrity of retinal pigment epithelium

 

Reduction in extracellular autofluorescent deposits, a hallmark of dry AMD.

 

INM-755: Dermatology Program – Continuing to seek strategic partnerships

 

Further development of the INM-755 CBN cream is expected to extend beyond its application in Epidermolysis bullosa (“EB”), potentially encompassing broader indications related to chronic, severe itch with larger target populations and potential commercial opportunities. InMed continues to assess potential partnership opportunities for the advancement of INM-755.

 

Continues to strengthen intellectual property portfolio

 

InMed continues to develop its patent portfolio and increase the commercial value of its programs to ensure the long-term protection of our drug research and development efforts. In recent months, InMed has been issued three U.S. patents: one for its formulation and method of use in the treatment of EB and related connective tissue disorders, one for a biosynthesis manufacturing processes and one for an ocular drug delivery formulation.

 

BayMedica commercial subsidiary

 

BayMedica, a leading supplier of non-intoxicating rare cannabinoids to the health and wellness sector, has experienced sustained revenue growth during the fiscal year 2024, reaching $4.6M, representing an 11% increase over the previous year. 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, 2024, the Company recorded a net loss of $7.7M, compared with a net loss of $7.9M for the previous year.

 

Research and development and patents expenses were $3.8M for year ended June 30, 2024, compared with $3.7M for the year ended June 30, 2023. However, we expect our research and development expenses to increase significantly in future periods as we continue to implement our business strategy. 

 

The Company incurred general and administrative expenses of $5.3M for the year ended June 30, 2024, compared to $5.8M in the previous year. The decrease was primarily from a combination of changes in the InMed segment, including lower office and admin fees and investor relations expenses. This was offset by a slight increase in sales and marketing expenses within the BayMedica segment.

 

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The Company realized sales of $4.6M in our BayMedica segment for the year ended June 30, 2024, representing an increase of $0.5M, or 11%, for the year ended June 30, 2024, as compared to the year ended June 30, 2023.

 

As of June 30, 2024, we had cash, cash equivalents and short-term investments of $6.6 million The Company expects its cash will be sufficient to fund its planned operating expenses and capital expend to the end of the fourth quarter of calendar year 2024, depending on the level and timing of realizing BayMedica revenues as well as the level and timing of the Company’s operating expenses.

 

Table 1. Consolidated Balance Sheet

 

InMed Pharmaceuticals Inc.

CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)

Expressed in U.S. Dollars

 

   June 30,   June 30, 
   2024   2023 
   (unaudited)     
   $   $ 
ASSETS      
Current        
Cash and cash equivalents   6,571,610    8,912,517 
Short-term investments   43,064    44,422 
Accounts receivable (less provision for credit losses of $nil and $66,775 in June 30, 2024 and 2023, respectively)   352,838    260,399 
Inventories, net   1,244,324    1,616,356 
Prepaids and other current assets   477,749    498,033 
Total current assets   8,689,585    11,331,727 
           
Non-Current          
Property, equipment and ROU assets, net   1,249,999    723,426 
Intangible assets, net   1,783,198    1,946,279 
Other assets   100,000    104,908 
Total Assets   11,822,782    14,106,340 
           
LIABILITIES AND SHAREHOLDERS’ EQUITY          
Current          
Accounts payable and accrued liabilities   1,654,011    1,608,735 
Current portion of lease obligations   317,797    375,713 
Deferred rent   -    16,171 
Total current liabilities   1,971,808    2,000,619 
           
Non-current          
Lease obligations, net of current portion   644,865    15,994 
Total Liabilities   2,616,673    2,016,613 
Commitments and Contingencies (Note 13)          
           
Shareholders’ Equity          
Common shares, no par value, unlimited authorized shares: 8,918,956 and 3,328,191 as of June 30, 2024 and 2023, respectively, issued and outstanding   82,784,400    77,620,252 
Additional paid-in capital   35,368,899    35,741,115 
Accumulated deficit   (109,075,759)   (101,400,209)
Accumulated other comprehensive income   128,569    128,569 
Total Shareholders’ Equity   9,206,109    12,089,727 
Total Liabilities and Shareholders’ Equity   11,822,782    14,106,340 

 

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Table 2. Consolidated Statements of Operations

 

InMed Pharmaceuticals Inc.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)

Expressed in U.S. Dollars

 

   Year Ended 
   June 30 
   2024   2023 
   $   $ 
         
Sales   4,597,730    4,135,561 
Cost of sales   3,496,817    2,732,525 
Gross profit   1,100,913    1,403,036 
           
Operating Expenses          
Research and development and patents   3,765,028    3,732,056 
General and administrative   5,250,715    5,847,518 
Amortization and depreciation   219,600    202,249 
Foreign exchange loss   61,921    48,175 
Total operating expenses   9,297,264    9,829,998 
           
Other Income (Expense)          
Interest and other income   527,901    492,440 
Loss before income taxes   (7,668,450)   (7,934,522)
           
Tax expense   (7,100)   (13,100)
Net loss for the period   (7,675,550)   (7,947,622)
           
Net loss per share for the period          
Basic and diluted   (1.01)   (3.25)
Weighted average outstanding common shares          
Basic and diluted   7,621,075    2,448,458 

 

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Table 3. Consolidated Statements of Cash Flows

 

InMed Pharmaceuticals Inc.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited)

For the year ended June 30, 2024 and 2023

Expressed in U.S. Dollars

 

   June 30,
2024
   June 30,
2023
 
   $   $ 
Cash provided by (used in):        
Operating Activities        
Net loss   (7,675,550)   (7,947,622)
Items not requiring cash:          
Amortization and depreciation   219,600    202,249 
Share-based compensation   137,714    278,155 
Amortization of right-of-use assets   384,918    393,748 
Interest income received on short-term investments   (1,250)   (803)
Unrealized foreign exchange loss   12,262    1,183 
Inventory write-down   305,812    308,937 
Credit losses   -    46,775 
Changes in operating assets and liabilities:          
Inventories   66,220    565,561 
Prepaids and other currents assets   20,284    299,192 
Other non-current assets   4,908    5,507 
Accounts receivable   (92,439)   (219,147)
Accounts payable and accrued liabilities   45,282    (806,530)
Deferred rent   (16,171)   16,171 
Lease obligations   (397,422)   (426,575)
Total cash used in operating activities   (6,985,832)   (7,283,199)
           
Investing Activities          
Payment of acquisition consideration   -    (500,000)
Payment of deposit on equipment   -    (1,790)
Sale of short-term investments   42,082    42,268 
Purchase of short-term investments   (42,082)   (42,268)
Purchase of property and equipment   (9,293)   (160,014)
Total cash (used in) provided by investing activities   (9,293)   (661,804)
           
Financing Activities          
Shares issued for cash          
share issuance costs          
Proceeds from the exercise of pre-funded warrants   175    646 
Proceeds from private placement net of issuance costs   4,654,043    10,680,008 
Total cash provided by financing activities   4,654,218    10,680,654 
           
Increase in cash during the period   (2,340,907)   2,735,649 
Cash and cash equivalents beginning of the period   8,912,517    6,176,866 
Cash and cash equivalents end of the period   6,571,610    8,912,515 
           
SUPPLEMENTARY CASH FLOW INFORMATION:          
Cash Paid During the Year for:          
Income taxes  $-   $- 
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   $- 

 

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About InMed

 

InMed Pharmaceuticals is a pharmaceutical company focused on developing a pipeline of proprietary small molecule drug candidates targeting the CB1/CB2 receptors. InMed’s pipeline consists of three drug development programs in the treatment of Alzheimer’s, ocular and dermatological indications. Together with our subsidiary BayMedica, we are a global leader in the manufacturing, development and commercialization of products based on rare cannabinoids and their proprietary, small molecule drug 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: cclancy@inmedpharma.com

 

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: expecting revenue fluctuations based on distributor order patterns; remaining optimistic about the long-term growth potential in the rare cannabinoids sector as the business dynamics and commercial opportunities continue to mature; advancing our pharmaceutical pipeline using rare cannabinoids for potential therapeutic applications in dermatology, ocular and neurodegenerative disease; 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; further development and commercial uses of the INM-755; expectations that the Company’s cash will be sufficient to fund its planned operating expenses and capital expenditure requirements to the end of 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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