0001213900-22-072460.txt : 20221115 0001213900-22-072460.hdr.sgml : 20221115 20221114174411 ACCESSION NUMBER: 0001213900-22-072460 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20221111 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20221115 DATE AS OF CHANGE: 20221114 FILER: COMPANY DATA: COMPANY CONFORMED NAME: InMed Pharmaceuticals Inc. CENTRAL INDEX KEY: 0001728328 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] 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: 221388214 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 ea168652-8k_inmedpharma.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): November 11, 2022

 

 

 

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 8.01 Other Events

 

On November 11, 2022, InMed Pharmaceuticals Inc. announced financial results for the first quarter of fiscal year 2023, ended September 30, 2022.

 

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 11, 2022
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: November 14, 2022 By:

/s/ Brenda Edwards

  Brenda Edwards Interim,
Chief Financial Officer

 

 

2

 

 

 EX-99.1 2 ea168652ex99-1_inmedpharma.htm NEWS RELEASE, DATED NOVEMBER 11, 2022

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 First Quarter Fiscal 2023 Financial Results and Provides Business Update

 

Vancouver, BC – November 11, 2022 – InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (Nasdaq: INM), a leader in the pharmaceutical research, development and manufacturing of rare cannabinoids and cannabinoid analogs, today reported financial results for the first quarter of fiscal year 2023, ended September 30, 2022.

 

The Company’s condensed financial statements and related MD&A for the first quarter of fiscal year 2023, ended September 30, 2022 will be available at www.inmedpharma.com and at www.sedar.com.

 

Eric A. Adams, InMed CEO, states, “In the first quarter of our new fiscal year, we continue to strengthen our pharmaceutical pipeline in dermatology, ocular and neurodegenerative diseases, as well as continue to screen our library of proprietary analogs for additional therapeutic candidates. Throughout the remainder of the year and into calendar year 2023, we have many milestones to look forward to in our clinical and preclinical programs, including the completion of our Phase 2 clinical trial in epidermolysis bullosa as well as advancing our glaucoma program towards human trials.”

 

Business Update

 

Pharmaceutical Development Programs

 

INM-755 for the treatment of Epidermolysis Bullosa (“EB”)

 

Enrollment and patient treatment in the Company’s Phase 2 clinical trial, 755-201-EB, has continued through the first quarter and is expected to complete during calendar year 2022.

 

InMed’s Phase 2 clinical trial now has all 11 clinical trial sites fully activated to screen and enroll patients. The clinical trial is taking place in seven countries (Austria, Germany, Greece, France, Italy, Israel and Spain).

 

InMed is evaluating the safety of INM-755 (cannabinol) cream and its preliminary efficacy in treating symptoms and wound healing in persons with EB over a 28-day treatment period. This study marks the first time cannabinol (“CBN”) has advanced to a Phase 2 clinical trial to be investigated as a therapeutic option to treat a disease.

 

 

 

INM-088 for the treatment of glaucoma

 

The Company continues to do necessary preclinical work including toxicology and GLP studies in advance of human clinical trials.

 

Earlier in the year, the Company completed a pre-Investigational New Drug (“pIND”) application discussion with the U.S. Food and Drug Administration (“FDA”) regarding manufacturing, preclinical studies and early clinical development plans for INM-088, a CBN formulation in development for glaucoma. The Company gained alignment with FDA on the design of the initial Phase 1-2 clinical trial to gather preliminary data on the safety and efficacy of INM-088 treatment.

 

InMed data suggest CBN is the cannabinoid of choice for neuroprotection and lowering intraocular pressure in glaucoma and potentially other ocular diseases.

 

New cannabinoid analogs for the treatment of neurodegenerative diseases

 

The Company continues to advance discovery work to identify an appropriate compound for a preclinical development program for treating neurodegenerative disorders such as Alzheimer’s disease, Parkinson’s disease and Huntington’s disease.

 

The Company remains focused on the generation of proprietary cannabinoid analogs to support its pharmaceutical drug development programs. As these novel cannabinoid analogs are patentable, they protect the long-term research investment and commercial opportunities.

 

BayMedica commercial activities

 

BayMedica commercial activities remain steady as the Company continues to work through existing inventories as a B2B supplier of rare cannabinoids to the health and wellness market. The Company continues to explore potential opportunities for structured supply agreements, commercial collaborations and review other strategic alternatives for the commercial aspect of its business.

 

Financial and Operational Highlights:

 

For the three months ended September 30, 2022, the Company recorded a net loss of $3.5 million, or $4.06 per share, compared with a net loss of $3.0 million, or $6.17 per share, for the three months ended September 30, 2021.

 

Research and development expenses were $1.4 million for the three months ended September 30, 2022, compared with $1.5 million for the three months ended September 30, 2021. The decrease in research and development and patents expenses was primarily due to decreased activities related to the INM-755 Phase 2 clinical trials which were offset by the inclusion of BayMedica operating results following the acquisition date.

 

2

 

 

The Company incurred general and administrative expenses of $1.6 million for the three months ended September 30, 2022, compared with $1.4 million for the three months ended September 30, 2021. The increase is due to the inclusion of BayMedica operating results following the acquisition date.

 

The Company realized sales of $0.3 million in our BayMedica segment for the for the three months ended September 30, 2022, the result of the manufacturing and sale of bulk rare cannabinoid products following the acquisition of BayMedica in October 2021. As the period ended September 30, 2021 predated the acquisition of BayMedica, there are no comparable revenues in 2021.

 

At September 30, 2022, the Company’s cash, cash equivalents and short-term investments were $9.4 million, which compares to $6.2 million at June 30, 2022. On September 13, 2022, the Company closed a $6.0 million private placement with two healthcare-focused institutional investors. Based on the current forecast, which is subject to potential revisions in the future, the Company’s cash reserves are estimated to last into the second half of fiscal 2023, and possibly into the first quarter of fiscal 2024 (being the third calendar quarter of 2023), depending on the level and timing of realizing revenues from the sale of BayMedica inventory as well as the level and timing of the Company’s operating expenses.

 

As a result of the decision to de-emphasize the commercial business due to lower demand outlook and downward pricing pressure, the Company incurred a write-down of inventories to net realizable value of $0.6 million during the period ended September 30, 2022.

 

At September 30, 2022, the Company’s total issued and outstanding shares were 908,766, or 1,510,011 including all outstanding pre-funded warrants which are considered common share equivalents. During the three months ending September 30, 2021, including the pre-funded warrants, the weighted average number of common shares was 865,619, which is used for the calculation of loss per share for the interim period.

 

3

 

 

Table 1: Condensed Consolidated Interim Balance Sheets:

 

InMed Pharmaceuticals Inc. 

CONDENSED CONSOLIDATED INTERIM BALANCE SHEETS (unaudited) 

As at September 30, 2022 and June 30, 2022

Expressed in U.S. Dollars

 

 

   September 30,   June 30, 
   2022   2022 
   $   $ 
ASSETS        
Current        
Cash and cash equivalents   9,350,427    6,176,866 
Short-term investments   42,125    44,804 
Accounts receivable   15,169    88,027 
Inventories   1,778,523    2,490,854 
Prepaids and other assets   356,665    797,225 
Total current assets   11,542,909    9,597,776 
           
Non-Current          
           
Property, equipment and ROU assets, net   802,369    904,252 
Intangible assets, net   2,067,922    2,108,915 
Other assets   171,130    176,637 
Total Assets   14,584,330    12,787,580 
           
LIABILITIES AND SHAREHOLDERS’ EQUITY          
Current          
Accounts payable and accrued liabilities   2,362,190    2,415,265 
Current portion of lease obligations   404,163    404,276 
Deferred revenue   15,700    - 
Acquisition consideration payable   500,000    500,000 
Total current liabilities   3,282,053    3,319,541 
Non-current          
Lease obligations   294,337    389,498 
Total Liabilities   3,576,390    3,709,039 
           
Shareholders’ Equity          
Common shares, no par value, unlimited authorized shares: 908,766 (June 30, 2022 - 650,667) issued and outstanding   72,671,392    70,718,461 
Additional paid-in capital   35,170,766    31,684,098 
Accumulated deficit   (96,962,787)   (93,452,587)
Accumulated other comprehensive income   128,569    128,569 
Total Shareholders’ Equity   11,007,940    9,078,541 
Total Liabilities and Shareholders’ Equity   14,584,330    12,787,580 

 

4

 

 

Table 2: Condensed Consolidated Interim Statements of Operations and Comprehensive Loss:

 

InMed Pharmaceuticals Inc.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited)

For the three months ended September 30, 2022 and 2021

Expressed in U.S. Dollars

 

 

   Three Months Ended 
   September 30 
   2022   2021 
   $   $ 
Sales   320,788    - 
Cost of sales   235,034    - 
Inventory write-down   576,772    - 
Gross loss   (491,018)   - 
           
Operating Expenses          
Research and development and patents   1,378,653    1,491,252 
General and administrative   1,560,477    1,372,867 
Amortization and depreciation   49,048    28,532 
Total operating expenses   2,988,178    2,892,651 
           
Other Income (Expense)          
Interest and other income   72,587    5,148 
Foreign exchange loss   (96,791)   (84,112)
           
Loss before income taxes   (3,503,400)   (2,971,615)
           
Tax expense   (6,800)   - 
Net loss for the period   (3,510,200)   (2,971,615)
Net loss per share for the period          
Basic and diluted   (4.06)   (6.17)
Weighted average outstanding common shares          
Basic and diluted   865,619    481,902 

 

5

 

 

Table 3: Condensed Consolidated Interim Statements of Cash Flows:

 

InMed Pharmaceuticals Inc.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS (unaudited)

For the three months ended September 30, 2022 and 2021

Expressed in U.S. Dollars

 

 

   2022   2021 
Cash provided by (used in):  $   $ 
         
Operating Activities        
Net loss for the period   (3,510,200)   (2,971,615)
Items not requiring cash:          
Amortization and depreciation   49,048    28,532 
Share-based compensation   116,680    111,142 
Amortization of right-of-use assets   99,460    25,906 
Interest income received on short-term investments   (120)   (23)
Unrealized foreign exchange loss   2,796    1,262 
Inventory write-down   576,772    - 
Payments on lease obligations   (100,903)   (17,411)
Changes in non-cash working capital:          
Inventories   135,559    - 
Prepaids and other assets   440,560    634,410 
Other non-current assets   5,507    6,030 
Accounts receivable   72,858    (2,923)
Accounts payable and accrued liabilities   (159,260)   (469,227)
Deferred revenue   15,700    - 
Total cash used in operating activities   (2,255,543)   (2,653,917)
           
Investing Activities          
Short-term loan   -    (250,000)
Total cash used in investing activities   -    (250,000)
           
Financing Activities          
Shares issued for cash   6,000,365    11,999,825 
Share issuance costs   (571,261)   (1,115,129)
Total cash provided by financing activities   5,429,104    10,884,696 
Increase (decrease) in cash during the period   3,173,561    7,980,779 
Cash and cash equivalents beginning of the period   6,176,866    7,363,126 
Cash and cash equivalents end of the period   9,350,427    15,343,905 

 

6

 

 

About InMed: InMed Pharmaceuticals is a global leader in the pharmaceutical research, development and manufacturing of rare cannabinoids and cannabinoid analogs, including clinical and preclinical programs targeting the treatment of diseases with high unmet medical needs.  We also have significant know-how in developing proprietary manufacturing approaches to produce cannabinoids for various market sectors. For more information, visit www.inmedpharma.com and www.baymedica.com.

 

Investor Contact:

Colin Clancy

Vice President, Investor Relations

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: continuing to strengthen the pharmaceutical pipeline in dermatology, ocular and neurodegenerative diseases; continuing to screen a library of proprietary analogs for additional therapeutic candidates; expecting many milestones in the clinical and preclinical programs; evaluating the safety of INM-755 (cannabinol) cream and its preliminary efficacy in treating symptoms; the completion of Phase 2 clinical trial in epidermolysis bullosa during calendar year 2022; advancing the glaucoma program towards human trials; CBN being the cannabinoid of choice for neuroprotection and lowering intraocular pressure in glaucoma and potentially other ocular diseases; advancing discovery work to identify an appropriate compound for a preclinical development program for treating neurodegenerative disorders such as Alzheimer’s disease, Parkinson’s disease and Huntington’s disease; the generation of proprietary cannabinoid analogs to support the Company’s pharmaceutical drug development programs; BayMedica exploring potential opportunities for structured supply agreements, commercial collaborations and review other strategic alternatives for the commercial aspect of its business; the Company’s current cash reserves are estimated to last into the second half of fiscal 2023, and possibly into the first quarter of fiscal 2024.

 

With respect to the forward-looking information contained in this news release, InMed has made numerous assumptions. While InMed considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies.

 

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.

 

 

7

 

 

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Cover
Nov. 11, 2022
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Nov. 11, 2022
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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