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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

 

FORM 8-K

 

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): November 14, 2024

 

 

 

INMED PHARMACEUTICALS INC.

(Exact Name of Company as Specified in Charter)

 

 

 

British Columbia   001-39685   98-1428279
(State or Other Jurisdiction
of Incorporation)
  (Commission File Number)   (IRS Employer
Identification No.)

 

InMed Pharmaceuticals Inc.
Suite 1445 - 885 W. Georgia Street
,
Vancouver
, B.C. Canada
  V6C 3E8
(Address of Principal Executive Offices)   (Zip Code)

 

Company’s telephone number, including area code: (604) 669-7207

 

Not applicable

(Former Name or Former Address, if Changed Since Last Report)

 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Shares, no par value   INM   The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

 

Emerging growth company  

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  

 

 

 

 

 

 

Item 7.01 Regulation FD Disclosure.

 

On November 14, 2024, the Company announced the financial results for the first quarter of fiscal year 2025 which ended September 30, 2024.

 

The information set forth in this Item 7.01, including Exhibits 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information set forth in this Item 7.01, including Exhibit 99.1, shall not be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits:

 

The following exhibits shall be deemed to be furnished, and not filed:

 

Exhibit No.   Description
99.1   News release, dated November 14, 2024
104   Cover Page Interactive Data File (embedded within the Inline XBRL document and included as Exhibit 101)

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  INMED PHARMACEUTICALS INC.
     
Date: November 14, 2024 By: /s/ Eric A Adams     
    Eric A Adams
President & CEO

 

 

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Exhibit 99.1

 

NASDAQ: INM

 

1445 – 885 West Georgia St.

Vancouver, BC, Canada V6C 3E8

Tel: +1.604.669.7207

Email: info@inmedpharma.com

www.inmedpharma.com

 

InMed Reports First Quarter Fiscal 2025 Financial Results and Provides Business Update

 

Vancouver, British Columbia – November 14, 2024. InMed Pharmaceuticals Inc. (NASDAQ: INM) (“InMed” or the “Company”), a pharmaceutical company focused on developing a pipeline of proprietary small molecule drug candidates for diseases with high unmet medical needs, today reports financial results for the first quarter of the fiscal year 2025 which ended September 30, 2024.

 

The Company’s full financial statements and related MD&A for the first quarter ended September 30, 2024, are available at www.inmedpharma.com, www.sedar.com and at www.sec.gov.

 

Eric A. Adams, InMed Chief Executive Officer, commented, “Fiscal 2025 has commenced on a positive trajectory, with notable progress across our pharmaceutical programs and commercial operations. Our Alzheimer’s treatment candidate, INM-901, demonstrated robust progress in the first quarter, with initial read-out from a long-term preclinical study providing strong data, including achieving statistical significance in certain behavioural criteria. We are encouraged by the promising data supporting this program and the multiple potential mechanisms of action observed with this drug candidate. The Alzheimer’s research landscape is rapidly evolving, with increasing attention on neuroinflammation and other key mechanisms, aligning closely with InMed’s research focus and direction. We look forward to communicating additional long-term preclinical data in calendar 4Q 2024.”

 

Adams continued, “On the corporate front, the Company’s recent announcement to implement a reverse split to regain Nasdaq compliance became effective today, November 14, 2024, underpinning the Company’s commitment to maintaining its listing on a major exchange while actively exploring strategic opportunities to enhance long-term shareholder value.”

 

Business Update - Pharmaceutical Development Programs

 

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

 

INM-901 is a proprietary small molecule drug candidate with multiple mechanisms of action, currently in development as a potential treatment for Alzheimer’s disease. In the first quarter, the Company announced key milestones, including positive behavioral data from long-term preclinical studies that reinforce and enhance previous findings. Additionally, new data showed that INM-901 can be administered orally, achieving therapeutic levels in the brain comparable to those obtained through intraperitoneal (“IP”) injection, a standard method of drug administration in preclinical neurodegenerative research. Ongoing studies are also examining receptor interactions to better understand the mechanisms of action (“MoA”) and drug metabolism and pharmacokinetics (“DMPK”).

 

 

 

 

Next steps include conducting further molecular analyses from the recently completed long-term preclinical dosing study to more precisely characterize the drug’s mechanisms of action. Data read-out is anticipated in the calendar 4Q 2024.

 

INM-089: Targeting the treatment of dry Age-related Macular Degeneration (“AMD”)

 

INM-089 is a proprietary small molecule drug candidate being studied in the treatment of dry AMD.  Next steps in the drug development pathway include additional in vivo preclinical dose ranging studies, alongside continued Chemistry, Manufacturing, and Controls (“CMC”) activities for both the drug substance and drug product. Following these efforts, Good Laboratory Practice (“GLP”) studies are set to commence.

 

Financial commentary:

 

BayMedica commercial business generated revenues of $1.3M for the three months ending September 30, 2024, compared to $0.9M for the same period last year, reflecting a 40% increase and a fourth consecutive quarter of consistent revenue. Additionally, BayMedica reported net income of $0.3M, or 24% as a percentage of sales, for the quarter, showing continued progress as a profitable business unit. BayMedica also continues to reduce manufacturing costs, which has led to improved margins over time.

 

Research and development and patent expenses were $0.8M for the three months ended September 30, 2024, compared with $1.3M for the three months ended September 30, 2023. The decrease in research and development and patents expenses was primarily due to reduced spending on external contractors, patent fees, and compensation. We expect research and development expenses to increase in calendar year 2025 as the Company advances preclinical work on INM-901 and IND-enabling studies in ocular disease.

 

As of September 30, 2024, the Company’s cash, cash equivalents and short-term investments were $5.6M, which compares to $6.6M at June 30, 2024. 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 through to the end of the first quarter of calendar year 2025, depending on the level and timing of BayMedica commercial revenues, as well as the level and timing of our operating expenses.

 

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Table 1. CONDENSED CONSOLIDATED BALANCE SHEETS 

Expressed in U.S. Dollars 

 

   September 30,   June 30, 
   2024   2024 
   (unaudited)     
   $   $ 
ASSETS        
Current        
Cash and cash equivalents   5,583,039    6,571,610 
Short-term investments   43,203    43,064 
Accounts receivable (less provision for credit losses of $nil and $66,775 in September 30, 2024 and June 30, 2024, respectively)   284,695    352,838 
Inventories, net   1,220,073    1,244,324 
Prepaids and other current assets   148,882    477,749 
Total current assets   7,279,892    8,689,585 
           
Non-Current          
Property, equipment and right-of-use (“ROU”) assets, net   1,343,009    1,249,999 
Intangible assets, net   1,742,205    1,783,198 
Other assets   100,000    100,000 
Total Assets   10,465,106    11,822,782 
           
LIABILITIES AND SHAREHOLDERS’ EQUITY          
Current          
Accounts payable and accrued liabilities   1,011,619    1,654,011 
Current portion of lease obligations   424,260    317,797 
Total current liabilities   1,435,879    1,971,808 
           
Non-current          
Lease obligations, net of current portion   633,783    644,865 
Total Liabilities   2,069,662    2,616,673 
Commitments and Contingencies (Note 11)          
           
Shareholders’ Equity          
           
Common Shares, no par value, unlimited authorized shares: 667,012 and 445,948, as of September 30, 2024 and June 30, 2024, respectively, issued and outstanding   84,198,673    82,784,400 
Additional paid-in capital   34,821,829    35,368,899 
Accumulated deficit   (110,753,627)   (109,075,759)
Accumulated other comprehensive income   128,569    128,569 
Total Shareholders’ Equity   8,395,444    9,206,109 
Total Liabilities and Shareholders’ Equity   10,465,106    11,822,782 

 

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Table 2. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS UNAUDITED 

Expressed in U.S. Dollars 

 

   Three Months Ended 
   September 30, 
   2024   2023 
   $   $ 
         
Sales   1,264,638    901,862 
Cost of sales   771,225    880,620 
Gross profit   493,413    21,242 
           
Operating Expenses          
Research and development and patents   771,180    1,292,093 
General and administrative   1,421,926    1,298,731 
Amortization and depreciation   54,579    54,832 
Foreign Exchange (Gain) Loss   (19,310)   48,457 
Total operating expenses   2,228,375    2,694,113 
           
Other Income (Expense)          
Interest and other income   57,094    136,043 
Loss before income taxes   (1,677,868)   (2,536,828)
         - 
Tax expense   -    - 
Net loss for the period   (1,677,868)   (2,536,828)
           
Net loss per share for the period          
Basic and diluted   (2.17)   (15.24)
Weighted average outstanding common shares          
Basic and diluted   620,127    166,410 

 

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Table 3. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS UNAUDITED 

Expressed in U.S. Dollars 

 

   September 30,
2024
   September 30,
2023
 
   $   $ 
Cash provided by (used in):        
         
Operating Activities        
Net loss   (1,677,868)   (2,536,828)
Items not requiring cash:          
Amortization and depreciation   54,579    54,832 
Share-based compensation   28,964    25,191 
Amortization of right-of-use assets   90,401    94,532 
Interest income received on short-term investments   (519)   (538)
Unrealized foreign exchange loss   5,270    2,018 
Inventory write-down   -    92,930 
Changes in operating assets and liabilities:          
Inventories   24,251    390,329 
Prepaids and other currents assets   328,867    283,018 
Other non-current assets   -    3,118 
Accounts receivable   68,143    94,549 
Accounts payable and accrued liabilities   (642,392)   (562,484)
Deferred rent   -    (16,171)
Lease obligations   (106,506)   (98,709)
Total cash used in operating activities   (1,826,810)   (2,174,213)
           
Investing Activities          
Sale of short-term investments   21,324    21,317 
Purchase of short-term investments   (21,324)   (21,317)
Total cash (used in) provided by investing activities   -    - 
           
Financing Activities          
Proceeds from private placement   1,030,063    - 
Share issuance costs   (191,824)   - 
Total cash provided by financing activities   838,239    - 
           
Increase in cash during the period   (988,571)   (2,174,213)
           
Cash and cash equivalents beginning of the period   6,571,610    8,912,517 
Cash and cash equivalents end of the period   5,583,039    6,738,304 
           
SUPPLEMENTARY CASH FLOW INFORMATION:          
Cash Paid During the Year for:          
Income taxes  $-   $- 
Interest  $-   $- 
           
SUPPLEMENTARY DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:          
Recognition of Right-of-use asset and corresponding operating lease liability  $187,223   $- 

 

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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 separate programs in the treatment of Alzheimer’s, ocular and dermatological indications. For more information, visit www.inmedpharma.com.

 

Investor Contact:

 

Colin Clancy

Vice President, Investor Relations

and Corporate Communications

T: +1 604 416 0999

E: ir@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 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; exploring strategic opportunities to enhance long-term shareholder value; 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; potential to improve margins over time; expectations that the Company’s cash will be sufficient to fund its planned operating expenses and capital expenditure requirements to the end of the first quarter of calendar year 2025.

 

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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