U.S. 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):

September 22, 2021

 

ODYSSEY GROUP INTERNATIONAL, INC.

(Exact name of small business issuer as specified in its charter)

 

Nevada 333-250896 47-1022125

(State or other jurisdiction of incorporation)

(Commission File Number) (IRS Employer ID No.)

 

2372 Morse Avenue

Irvine, CA 92614

(Address of Principal Executive Offices)

 

(619) 832-2900

(Issuer’s Telephone Number)

 

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:

 

☐   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
Not Applicable Not Applicable Not Applicable

 

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

 

Title of each Class Trading Symbol Name of Each Exchange on Which Registered
Common Stock ($0.001 par value) ODYY OTC

 

 

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 12b2 of the Securities Exchange Act of 1934 (§240.12b2 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 Material Event

 

On September 22, 2021, Odyssey Group International, Inc. (the “Odyssey”) announced successful completion of its clinical trial site initiation visit and the start of subject screening and enrollment. The drug candidate PRV-002 is being developed to treat concussion as a novel neurosteroid delivered nasally. Odyssey’s Phase 1 clinical trial status can be viewed at www.clinicaltrials.gov.

 

Item 7.01 Regulation FD Disclosure

 

Attached is a copy of a press release being issued by the Company relating to the above-referenced matter, a copy of which is attached as Exhibit 99.1 and is hereby incorporated.

 

Item 9.01. Financial Statements and Exhibits.

 

(c) Exhibits.

 

Number Exhibit
99.1 Press Release

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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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.

 

Dated: September 24, 2021 Odyssey Group International, Inc.
   
  By:  /s/ J. Michael Redmond
    Chief Executive Officer

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  3  

Exhibit 99.1

 

 

Odyssey Group International Begins Enrolling Subjects for

Phase 1 Clinical Trial to Treat Concussion

 

Odyssey Group International, Inc. (OTC:ODYY) (the "Company" or "Odyssey"), a medical company focused on developing unique, life-saving medical products, today announced successful completion of their clinical trial site initiation visit and the start of subject screening and enrollment. The drug candidate PRV-002 is being developed to treat concussion as a novel neurosteroid delivered nasally. Odyssey’s Phase 1 clinical trial status can be viewed at www.clinicaltrials.gov.

 

“We are so excited to start enrollment for our human trials and establish a strong safety profile following PRV-002 nasal application. These studies will look at pharmacokinetics and drug tolerability at 3 dosage strengths. The most tolerated dose will be used in the subsequent trials to determine efficacy.” commented Jacob VanLandingham, Executive VP of Drug Development of Odyssey Group International.  

 

Odyssey screening and enrollment of subjects coincides with the completion of their Phase 1 clinical batch of PRV-002. The spray dried material has been filled in its unique breath-propelled nasal applicator and is being shipped this week to the trial site in preparation for first cohort dosing. Each device is uniquely labeled by the manufacturer to comply with the double-blinded nature of the study.

 

“We have a long history of managing successful Phase 1 clinical trials. We are excited to be enrolling subjects and look forward to administering PRV-002 and identifying a safe drug dosage based on tolerability and pharmacokinetics. We feel Odyssey’s unique breath-propelled drug-device combination will promote enrollment while the community need for a concussion treatment should enhance compliance. Concussion is an unmet need that needs to see an effective treatment get approved.” stated, Philip Ryan, MD, Principal Investigator at Nucleus Network, Inc.

 

About Odyssey Group International, Inc.

Odyssey Group International, Inc. (OTC:ODYY) is a technology and asset acquisition company with a focus in the area of life saving medical solutions. Odyssey's corporate mission is to create, acquire and accumulate distinct assets, intellectual properties, and exceptional technologies that provide meaningful medical solutions. The Company is focused on building and acquiring assets in areas that have an identified technological advantage, provide superior clinical utility, have a substantial market opportunity and provide solid returns to its valued shareholders and partners.

 

We encourage our shareholders to visit: http://www.odysseygi.com or  Twitter: @OdysseyGroupIn1.

 

About PRV-002

PRV-002 is a fully synthetic non-naturally occurring neurosteroid being developed for the treatment of mTBI (concussion). In preclinical studies, PRV-002 has demonstrated equivalent, if not superior, neuroprotective effects compared to related neurosteroids. Animal models of concussion demonstrated that PRV-002 reduces the behavioral pathology associated with brain injury symptoms such as memory impairment, anxiety, and motor/sensory performance. Additionally, PRV-002 is lipophilic and can easily cross the blood-brain barrier to rapidly eliminate swelling, oxidative stress and inflammation in the brain while restoring proper blood flow.

 

 

Forward-Looking Statements

This news release may contain forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to continue to raise needed funds, successfully complete the phase 1 trial, our ability to successfully develop products, rapid changes in our markets, changes in demand for our future products, and legislative, regulatory, competitive developments and general economic conditions.