0001213900-24-013526.txt : 20240214 0001213900-24-013526.hdr.sgml : 20240214 20240213193450 ACCESSION NUMBER: 0001213900-24-013526 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 16 CONFORMED PERIOD OF REPORT: 20240213 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240214 DATE AS OF CHANGE: 20240213 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: 24631175 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 ea193698-8k_inmedpharm.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): February 13, 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 February 13, 2024, the Company announced financial results for the second quarter of fiscal year 2024 which ended December 31, 2023.

 

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 February 13, 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: February 13, 2024 By: /s/ Eric A Adams  
    Eric A. Adams
    President & CEO

 

 

2

 

 

 EX-99.1 2 ea193698ex99-1_inmedpharm.htm NEWS RELEASE, DATED FEBRUARY 13, 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 Reports Second Fiscal Quarter 2024 Financial Results and Provides Business Update

 

●Advancing two new preclinical programs in Alzheimer’s and Age-Related Macular Degeneration
●Closed calendar year 2023 with cash position of US$9.5 million
●164% revenue growth in the commercial BayMedica subsidiary

 

Vancouver, BC – February 13, 2024 – InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (Nasdaq: INM), a leader in the manufacturing, development and commercialization of rare cannabinoids and proprietary cannabinoid analogs, today reports financial results for the second quarter of the fiscal year 2024 which ended December 31, 2023.

 

The Company’s full financial statements and related MD&A for the second quarter ended December 31, 2023, are available at www.inmedpharma.com, www.sedar.com and at www.sec.gov.

 

Eric A. Adams, InMed Chief Executive Officer, commented, “This period was another strong operational quarter for the Company, as we expanded our pharmaceutical pipeline with the launch of two new programs with a particular focus on proprietary small molecule drug development candidates. As outlined in our 2024 business update last month, we have further accelerated our development efforts in both INM-901 as a potential multimodal treatment option for Alzheimer’s disease and INM-089 in the treatment of Age-related Macular Degeneration.” Adams continued, “Our commercial subsidiary, BayMedica LLC, continues to grow revenues, up 164% compared to the same three month period last year. In addition, we ended calendar year 2023 with a cash position of over $9.5 million, allowing us to pursue several material milestones throughout calendar 2024.”

 

Business Update

 

Pharmaceutical Development Programs

 

INM-901 in treatment of Alzheimer’s disease:

 

Following the launch of INM-901 in October 2023, the next stages of longer-term preclinical studies are underway in a robust preclinical disease model and will be followed by studies of 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 and formulation.

 

Based on early in vitro research, INM-901 showed potential to target several biological pathways associated with Alzheimer’s, including neuroprotection of the brain neurons from beta-amyloid peptide-induced toxicity, a reduction in neuroinflammation 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.

 

 

INM-089 in the treatment of AMD

 

The Company is currently engaged in API and drug product formulation work and expects to initiate Investigational New Drug (“IND”)-enabling studies in mid-2024, with the anticipation of filing an IND application with regulatory authorities in calendar 1H 2025.

 

INM-089 preclinical research has shown promising results in preserving retinal function, proactively protecting retinal cells, and enhancing the thickness of the outer nuclear layer of the retina where photoreceptors are located.

 

INM-755: Assessing partnership opportunities

 

The comprehensive data and findings from the Phase 2 clinical trial will soon be available on the National Institutes of Health (“NIH”) clinicaltrials.gov website and the European Union Clinical Trials Register website. Additionally, an abstract will soon be published in Itch, the official journal of the International Forum for the Study of Itch.

 

The Company believes that INM-755 holds promise for further advancement in the treatment of chronic itch and other related ailments. The Company is currently seeking partnerships for continued development. For further details see press release date June 22, 2023.

 

BayMedica Commercial Subsidiary

 

BayMedica revenues continue to trend positively with $1.2 million for the three months ended December 31, 2023, representing a 164% growth over the same three month period last year and 37% quarter over quarter growth. The long-term outlook remains positive, as demand for rare cannabinoids ingredients to be used in combination with other cannabinoids in various formats continues to gain momentum. While we are optimistic about the long-term growth potential in the rare cannabinoids sector, we expect revenue fluctuations to continue in future quarters. BayMedica continues to make progress lowering manufacturing costs which should continue to improve margins over time.

 

Financing Activities and Results of Operations (expressed in US Dollars):

 

On October 26, 2023, the Company closed a Private Placement and Preferred Investment Option Exercise financing, for gross proceeds of $5.2 million. For further details see press release date October 26, 2023.

 

For the six months ended December 31, 2023, the Company recorded a net loss of $4.0 million, compared with a net loss of $5.6 million for the six months ended December 31, 2022.

 

Research and development and patents expenses were $1.9 million for the six months ended December 31, 2023, compared with $2.2 million for the six months ended December 31, 2022. The decrease in research and development and patents expenses was due to the Company having completed the INM-755 Phase 2 clinical trial, offset by an increase in external contractor fees and personnel expenses within the BayMedica segment.

 

The Company incurred general and administrative expenses of $2.7 million for the six months ended December 31, 2023, compared with $3.0 million for the six months ended December 31, 2022. The decrease results primarily from lower office and administration fees, accounting and legal fees in the InMed segment offset by higher accounting and legal fees, and marketing expenses in the BayMedica segment.

 

2

 

At December 31, 2023, the Company’s total issued and outstanding shares were 5,667,970. Subsequent to quarter end, 391,000 shares held in abeyance were issued to investors from the October 2023 financing activities. As of the date of these filings, the issued and outstanding shares are 6,058,970. During the three and six months ending December 31, 2023, the weighted average number of common shares was 7,973,465 and 5,650,828, which is used for the calculation of loss per share for the respective interim periods.

 

At December 31, 2023, the Company’s cash, cash equivalents and short-term investments were $9.5 million, which compares to $8.9 million at June 30, 2023. The increase in cash, cash equivalents and short-term investments during the six months to December 31, 2023, was primarily the result the October 26, 2023 financing, partially offset by cash outflows from operating activities.

 

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 expenses.

 

Table 1. CONDENSED CONSOLIDATED INTERIM BALANCE SHEETS

 

Expressed in U.S. Dollars

 

   December 31,     
   2023   June 30, 
   (unaudited)   2023 
   $   $ 
ASSETS        
Current        
Cash and cash equivalents   9,534,922    8,912,517 
Short-term investments   44,462    44,422 
Accounts receivable, net   372,870    260,399 
Inventories   744,839    1,616,356 
Prepaids and other current assets   1,112,977    498,033 
Total current assets   11,810,070    11,331,727 
           
Non-Current          
Property, equipment and ROU assets, net   1,481,102    723,426 
Intangible assets, net   1,864,292    1,946,279 
Other assets   100,000    104,908 
Total Assets   15,255,464    14,106,340 
           
LIABILITIES AND SHAREHOLDERS’ EQUITY          
Current          
Accounts payable and accrued liabilities   1,287,623    1,608,735 
Current portion of lease obligations   364,190    375,713 
Deferred rent   28,656    16,171 
Total current liabilities   1,680,469    2,000,619 
           
Non-current          
Lease obligations, net of current portion   802,784    15,994 
Total Liabilities   2,483,253    2,016,613 
           
Shareholders’ Equity          
Common shares, no par value, unlimited authorized shares:          
5,667,970 (June 30, 2023 - 3,328,191) issued and outstanding   79,936,633    77,620,252 
Additional paid-in capital   38,122,231    35,741,115 
Accumulated deficit   (105,415,222)   (101,400,209)
Accumulated other comprehensive income   128,569    128,569 
Total Shareholders’ Equity   12,772,211    12,089,727 
Total Liabilities and Shareholders’ Equity   15,255,464    14,106,340 

 

3

 

Table 2. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS (unaudited)

 

Expressed in U.S. Dollars

 

   For the Three Months
Ended		   For the Six Months
Ended		 
   December 31   December 31 
   2023   2022   2023   2022 
   $   $   $   $ 
                 
Sales   1,240,200    469,783    2,142,062    790,571 
Cost of sales   745,584    338,620    1,533,274    573,654 
Inventory write-down   170,474    -    263,404    576,772 
Gross profit   324,142    131,163    345,384    (359,855)
                     
Operating Expenses                    
Research and development and patents   609,791    851,356    1,901,884    2,230,009 
General and administrative   1,363,958    1,464,879    2,662,689    3,025,356 
Amortization and depreciation   55,234    49,049    110,066    98,097 
Foreign exchange (gain) loss   (59,896)   (20,237)   (11,439)   76,554 
Total operating expenses   1,969,087    2,345,047    4,663,200    5,430,016 
                     
Other Income (Expense)                    
Interest and other income   166,760    115,797    302,803    188,384 
Loss before income taxes   (1,478,185)   (2,098,087)   (4,015,013)   (5,601,487)
                     
Tax expense   -    (3,000)   -    (9,800)
Net loss for the period   (1,478,185)   (2,101,087)   (4,015,013)   (5,611,287)
                     
Net loss per share for the period                    
Basic and diluted   (0.19)   (0.91)   (0.71)   (3.54)
Weighted average outstanding common shares                    
Basic and diluted   7,973,465    2,300,526    5,650,828    1,583,073 

 

4

 

Table 3. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS (unaudited)

 

Expressed in U.S. Dollars

 

   2023   2022 
   $   $ 
Cash provided by (used in):        
Operating Activities        
Net loss   (4,015,013)   (5,611,287)
Items not requiring cash:          
Amortization and depreciation   110,063    98,097 
Share-based compensation   43,455    187,318 
Amortization of right-of-use assets   191,909    197,767 
Interest income received on short-term investments   (1,019)   (418)
Unrealized foreign exchange loss   978    2,167 
Inventory write-down   263,404    576,772 
Bad debts   -    25,085 
Changes in operating assets and liabilities:          
Inventories   608,113    300,576 
Prepaids and other currents assets   (614,944)   (29,706)
Other non-current assets   4,908    5,507 
Accounts receivable   (112,470)   (18,705)
Accounts payable and accrued liabilities   (321,106)   (508,871)
Deferred rent   12,485    16,171 
Lease obligations   (193,109)   (209,112)
Total cash used in operating activities   (4,022,346)   (4,968,639)
           
Investing Activities          
Payment of acquisition consideration   -    (500,000)
Sale of short-term investments   21,317    - 
Purchase of short-term investments   (21,317)   - 
Purchase of property and equipment   (9,291)   - 
Total cash used in investing activities   (9,291)   (500,000)
         - 
Financing Activities          
Proceeds from private placement net of issuance costs   4,654,042    10,744,351 
Total cash provided by financing activities   4,654,042    10,744,351 
           
Increase in cash during the period   622,405    5,275,712 
Cash and cash equivalents beginning of the period   8,912,517    6,176,866 
Cash and cash equivalents end of the period   9,534,922    11,452,578 
           
SUPPLEMENTARY CASH FLOW INFORMATION:          
Cash Paid During the Year for:          
Income taxes  $-   $9,800 
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 global leader in the manufacturing, development and commercialization of rare cannabinoids and proprietary cannabinoid analogs. Together with our subsidiary, BayMedica, we have unparalleled cannabinoid manufacturing capabilities to serve a spectrum of consumer markets, including pharmaceutical and health and wellness. We are a clinical-stage company developing a pipeline of rare cannabinoid therapeutics and dedicated to delivering new treatment alternatives to patients that may benefit from cannabinoid-based pharmaceutical drugs. 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. Forward-looking information in this news release includes statements about: INM-901 representing a unique and innovative treatment approach compared to current options available to patients; cash runway into calendar 3Q 2024; next stages of advanced preclinical studies of INM-901, including drug metabolism and pharmacokinetics as well as the initiation of pharmaceutical drug development activities such as manufacturing and formulation; disease-modifying effects in an Alzheimer’s disease treatment model; and the next stage of studies which may show how the cannabinoid analog INM-901 can improve neuronal function; assessing potential partnership opportunities for the advancement of INM-755; anticipating sustained volume growth over a 12-month period; improving margins over time; being 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; having significant know-how in developing proprietary manufacturing approaches to produce cannabinoids for various market sectors.

 

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
Feb. 13, 2024
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Feb. 13, 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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