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): April 27, 2021

 

 

 

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 April 26, 2021, the Company issued a press release announcing that its IntegraSyn™ cannabinoid manufacturing approach has achieved a level of 2g/L cannabinoid yield. A copy of the press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.

 

On April 27, 2021, the Company issued a press release announcing that it has provided written notice to the Toronto Stock Exchange (the “TSX”) regarding the voluntary delisting of its common shares. A copy of the press release is furnished as Exhibit 99.2 hereto and is incorporated herein by reference.

 

The information set forth in this Item 7.01, including Exhibit 99.1 and Exhibit 99.2, 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 April 26, 2021
99.2   News release, dated April 27, 2021

 

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: April 27, 2021 By:

/s/ Bruce Colwill

   

Bruce Colwill

Chief Financial Officer

 

 

2

 

Exhibit 99.1

 

TSX: IN

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 Achieves 2g/L Cannabinoid Yield with IntegraSyn™

 

This yield level demonstrates commercial viability; supports advancing to large-scale production

 

Vancouver, BC – April 26, 2021 – InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (Nasdaq: INM; TSX:IN), a clinical-stage company developing cannabinoid-based pharmaceutical drug candidates and leading the clinical development of cannabinol (“CBN”), today announced that its IntegraSyn™ cannabinoid manufacturing approach has achieved a level of 2g/L cannabinoid yield, a milestone that signals commercial viability and supports advancement to large-scale production in the coming months.

 

For its first application using the IntegraSyn™ approach, InMed set two main objectives to enable a cost-effective solution to cannabinoid production: to achieve a commercially viable yield higher than current industry standards and to lower overall manufacturing costs through process optimization. InMed’s IntegraSyn™ manufacturing approach was able to achieve both objectives. IntegraSyn™ utilizes an enzymatic biotransformation process as a part of an overall integrated cannabinoid manufacturing approach to overcome certain natural yield limitations of traditional biosynthesis for full cannabinoid assembly. Having achieved a 2g/L yield level, InMed will now focus on manufacturing scale-up to larger batch sizes while continuing process and enzyme optimization, targeting increased cannabinoid yield and further reducing the overall cost of goods. In parallel, the Company continues to prepare the manufacturing process to be Good Manufacturing Practice (GMP)-ready for pharmaceutical quality production. The next stage of large-scale production is to produce a batch with a target output of one kilogram of the selected cannabinoid in 2H2021 via a GMP-ready process.

 

“We are very pleased to have achieved this high yield at this stage and are looking forward to applying the IntegraSyn™ approach to large-scale production. As this scale-up progresses, we will also seek to further optimize our manufacturing and purification processes and further enhance the enzyme design. These ongoing improvements will focus on achieving even higher yields, beyond the already impressive 2g/L,” commented Eric Hsu, Senior Vice President, Preclinical R&D. “I would also like to acknowledge the Almac Group, our collaborator and contract manufacturing partner, for bringing their extensive knowledge and expertise to the program as we reached this important milestone.”

 

Michael Woudenberg, Vice President of Chemistry, Manufacturing and Controls, added, “In addition to achieving a commercially viable cannabinoid yield level, we have focused on utilizing cost-competitive starting materials to enable a cost-effective solution to pharmaceutical-grade cannabinoid production with IntegraSynTM. We believe this is especially important in accessing rare cannabinoids.”

 

 

 

 

About InMed: InMed Pharmaceuticals is a clinical-stage company developing a pipeline of cannabinoid-based pharmaceutical drug candidates, initially focused on the therapeutic benefits of cannabinol (“CBN”), in diseases with high unmet medical need. The Company is dedicated to delivering new therapeutic alternatives to patients that may benefit from cannabinoid-based pharmaceutical drugs. For more information, visit www.inmedpharma.com.

 

About IntegraSyn™: IntegraSyn™ is InMed’s integrated cannabinoid manufacturing system designed to efficiently and economically produce pharmaceutical-grade, bio-identical cannabinoids. The scalable and flexible IntegraSyn™ manufacturing system integrates multiple commercially proven methods to efficiently produce cannabinoids utilizing cost-effective processes.

 

About Almac Group: The Almac Group is an established contract development and manufacturing organization providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialization, API manufacture, formulation development, clinical trial supply, Interactive Response Technology through to commercial-scale manufacture. Almac is an international, privately-owned organization which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia. For more information please visit almacgroup.com.

 

Edison Group  
Joe Green/Laine Yonker  
T: +1.646.653.7030/+1.646.653.7035  
E:    jgreen@edisongroup.com  
  lyonker@edisongroup.com  

 

Cautionary Note Regarding Forward-Looking Information: 

 

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: commercial viability and advancement to large-scale production and the timing thereof; the focus of the Company on manufacturing scale-up to larger batch sizes while continuing process and enzyme optimization, targeting increased cannabinoid yield and reducing overall costs; the preparation to be GMP-ready; IntegraSyn™ being able to efficiently and economically produce pharmaceutical-grade, bio-identical cannabinoids; delivering new therapeutic alternatives to patients that may benefit from cannabinoid-based pharmaceutical drugs; and the next stage being a target output of one kilogram of the selected cannabinoid in 2H2021 via a GMP-ready process. With respect to the forward-looking information contained in this news release, InMed has made numerous assumptions regarding, among other things: that the manufacturing approach means commercial viability and possible large-scale production; cannabinoid yield can be increased; overall costs can be reduced; the manufacturing process is possible to be GMP-ready for pharmaceutical quality production; and optimization of the manufacturing and purification processes and further enhancement of enzyme design is possible. 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. Known risk factors include, among others: the outbreak and impact of COVID-19 may worsen; commercial viability and large-scale production may not be possible within anticipated timelines or at all; the manufacturing process may not be GMP-ready for pharmaceutical quality production; demand or interest for InMed’s products may decrease or cease; and economic and market conditions may become unstable or unfavorable. A more complete discussion of the risks and uncertainties facing InMed is disclosed in InMed’s filings with the Securities and Exchange Commission and the most recent Annual Information Form filed with Canadian securities regulatory authorities on SEDAR at www.sedar.com. 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.

 

NEITHER THE TORONTO STOCK EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

 

 

 

 

Exhibit 99.2

 

TSX:IN

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 Announces Voluntary Delisting from TSX

 

All common shares will continue to be listed and tradable on the Nasdaq

 

Vancouver, BC – April 27, 2021 – InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (Nasdaq:INM) (TSX:IN), a clinical-stage company developing cannabinoid-based pharmaceutical drug candidates and leading the clinical development of cannabinol (“CBN”), today announced that, based on the strong trading data on the Nasdaq, it has provided written notice to the Toronto Stock Exchange (the “TSX”) regarding the voluntary delisting of its common shares. InMed’s common shares will continue to be listed and tradable on the Nasdaq under “INM”.

 

The Company believes that the trading volume of its shares on the TSX no longer justifies the expense and administrative efforts associated with maintaining this dual listing. InMed’s listing on Nasdaq provides its shareholders with good liquidity, as Nasdaq has accounted for approximately 86% of its trading volume since its November 12, 2020 listing. The substantial savings in exchange fees, legal fees, and managerial time and effort to maintain a dual listing can be redirected into scientific programs, further advancing the business of the Company. InMed’s common shares will continue to be listed and traded on Nasdaq and its Canadian shareholders’ existing shares will trade through their brokers on the Nasdaq stock exchange. InMed anticipates that its common shares will be delisted from the TSX at the close of trading on or about May 7, 2021.

 

As most brokers in Canada, including discount and online brokers, have the ability to buy and sell securities listed on Nasdaq, InMed’s Nasdaq listing will continue to provide shareholders with the same accessibility to trade the Company’s common shares. Shareholders holding shares in Canadian brokerage accounts should contact their brokers to confirm how to trade InMed’s shares on the Nasdaq exchange.

 

For answers to frequently asked questions about the voluntary delisting, please visit  the FAQ section of the Company’s website.

 

About InMed: InMed Pharmaceuticals is a clinical-stage company developing a pipeline of cannabinoid-based pharmaceutical drug candidates, initially focused on the therapeutic benefits of cannabinol (CBN), in diseases with high unmet medical need. The Company is dedicated to delivering new therapeutic alternatives to patients that may benefit from cannabinoid-based pharmaceutical drugs. For more information, visit www.inmedpharma.com.

 

Investor Contact:  
   
Edison Group  
Joe Green/Laine Yonker  
T: +1.646.653.7030/+1.646.653.7035  
E:    jgreen@edisongroup.com  
  lyonker@edisongroup.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: the delisting of the common shares from the TSX; the achievement of administrative and regulatory efficiencies; the continued listing and trading of the common shares on NASDAQ; the ability of Canadian shareholders to trade through their brokers on NASDAQ; developing a pipeline of cannabinoid-based medications, initially focused on the therapeutic benefits of CBN, in diseases with high unmet medical need; and delivering new therapeutic alternatives to patients that may benefit from cannabinoid-based medicines.

 

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. Known risk factors include, among others: regulatory filings may not be filed or approved on a timely basis, or at all; InMed’s securities may not be delisted from the TSX in the time expected or at all; InMed may not be able to advance its product candidates on a timely basis, or at all; economic or market conditions may worsen; InMed’s cannabinoid manufacturing process and drug development programs may not deliver the expected level of results; and InMed may not be able to provide new therapeutic alternatives that benefit patients via cannabinoid-based medicines. A more complete discussion of the risks and uncertainties facing InMed is disclosed in InMed’s filings with the Security and Exchange Commission and the most recent Annual Information Form filed with Canadian securities regulatory authorities on SEDAR at www.sedar.com. 

 

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.

 

NEITHER THE TORONTO STOCK EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.