0001213900-24-042944.txt : 20240514 0001213900-24-042944.hdr.sgml : 20240514 20240514161250 ACCESSION NUMBER: 0001213900-24-042944 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20240514 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240514 DATE AS OF CHANGE: 20240514 FILER: COMPANY DATA: COMPANY CONFORMED NAME: InMed Pharmaceuticals Inc. CENTRAL INDEX KEY: 0001728328 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 000000000 STATE OF INCORPORATION: A1 FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39685 FILM NUMBER: 24944484 BUSINESS ADDRESS: STREET 1: SUITE 310, 815 W. HASTINGS STREET CITY: VANCOUVER STATE: A1 ZIP: V6C 1B4 BUSINESS PHONE: (604) 669-7207 MAIL ADDRESS: STREET 1: SUITE 310, 815 W. HASTINGS STREET CITY: VANCOUVER STATE: A1 ZIP: V6C 1B4 8-K 1 ea0206088-8k_inmed.htm CURRENT REPORT
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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): May 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 310 - 815 W. Hastings Street,

Vancouver, B.C.

Canada

  V6C 1B4
(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 May 14, 2024, the Company announced financial results and business update for the third quarter of the fiscal year 2024, which ended March 31, 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 May 14, 2024
104   Cover Page Interactive Data File (embedded within the Inline XBRL document and included as Exhibit 101)

 

1

 

 

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: May 14, 2024 By: /s/ Netta Jagpal 
   

Chief Financial Officer

 

 

2

 

 

EX-99.1 2 ea020608801ex99-1_inmed.htm NEWS RELEASE, DATED MAY 14, 2024

Exhibit 99.1

 

 

NASDAQ: INM

 

Suite 310-815 W. Hastings St.

Vancouver, BC, Canada V6C 1B4

Tel: +1.604.669.7207

Email: info@inmedpharma.com

www.inmedpharma.com

 

InMed Pharmaceuticals Reports Third Quarter Fiscal 2024 Financial Results and Provides Business Update

 

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, BC – May 14, 2024 – InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (Nasdaq: INM), 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.

 

2

 

 

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 (Note 11)          
           
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 (Note 12)          
Subsequent Events (Note 13)          

 

3

 

 

Table 2. InMed Pharmaceuticals Inc.

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)

Expressed in U.S. Dollars

 

   For the Three Months Ended
31-Mar
   For the Nine Months Ended
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 

 

4

 

 

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   $- 

 

5

 

 

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: 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 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.

 

 

6

 

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Cover
May 14, 2024
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date May 14, 2024
Entity File Number 001-39685
Entity Registrant Name INMED PHARMACEUTICALS INC.
Entity Central Index Key 0001728328
Entity Tax Identification Number 98-1428279
Entity Incorporation, State or Country Code A1
Entity Address, Address Line One Suite 310 - 815 W. Hastings Street
Entity Address, City or Town Vancouver
Entity Address, State or Province BC
Entity Address, Country CA
Entity Address, Postal Zip Code V6C 1B4
City Area Code 604
Local Phone Number 669-7207
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Shares, no par value
Trading Symbol INM
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Elected Not To Use the Extended Transition Period false
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