SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
September 15, 2020
Commission File Number 001-35203
(Translation of registrants name into English)
2015 Peel Street, Suite 1100
Montréal, Québec, Canada
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
Form 20-F ☐ Form 40-F ☒
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Yes ☐ No ☒
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Yes ☐ No ☒
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrants home country), or under the rules of the home country exchange on which the registrants securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrants security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ☐ No ☒
If Yes is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82- .
|99.1||Material Change Report Dated September 15, 2020.|
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, thereunto duly authorized.
|By:||/s/ Jocelyn Lafond|
|Title:||Vice President, Legal Affairs|
Date: September 15, 2020
MATERIAL CHANGE REPORT
Regulation 51-102 Respecting Continuous Disclosure Obligations
ITEM 1 NAME AND ADDRESS OF COMPANY
THERATECHNOLOGIES INC. (Theratechnologies)
2015 Peel Street
Canada H3A 1T8
ITEM 2 DATE OF MATERIAL CHANGE
September 10, 2020.
ITEM 3 NEWS RELEASE
Theratechnologies issued a press release with respect to the material change described below on September 10, 2020 via Globenewswire.
ITEM 4 SUMMARY OF MATERIAL CHANGE
Theratechnologies announced that it planned to pursue Phase 3 clinical development of tesamorelin for the treatment of Non-Alcoholic Steatohepatitis (NASH) in the general population.
ITEM 5 FULL DESCRIPTION OF MATERIAL CHANGE
5.1 Full description of material change
Theratechnologies announced that it planned to pursue Phase 3 clinical development of tesamorelin for the treatment of NASH in the general population.
Phase 3 clinical trial
Theratechnologies intends to submit its Phase 3 study protocol to the United States Food and Drug Administration (FDA) and the European regulatory agencies in the coming weeks. Subject to feedback from the regulatory agencies, the trial would involve approximately 650 patients with fibrosis scores of 2 and 3 and with a NAS score of at least 4 and also include a cohort of 50 people living with HIV. The enrollment of patients is planned for the first quarter of 2021. Patients will be treated for a period of 18 months. As per published regulatory guidelines, the primary endpoints will assess NAS score normalisation and absence of worsening of fibrosis stage, or fibrosis improvement ³ 1 stage and no worsening of NAS.
Theratechnologies intends to use a new investigational formulation of tesamorelin, known as F8, for the Phase 3 trial in NASH. In addition, a supplemental Biologics License Application is expected to be filed with the FDA in early 2022 in HIV-associated lipodystrophy using a convenient, multi-dose pen injector currently being developed for this new formulation.
The F8 is patent protected in the U.S. until 2033 and until 2034 in major European countries.
Furthermore, a notice of allowance was issued by the United States Patent and Trademark Office on a pending US patent application filed by the Massachusetts General Hospital in March 2020 relating to the treatment of hepatic disease using GHRH or analogues thereof. This patent application claims, amongst other things, a method for the treatment of NAFLD or NASH in a patient via the administration of tesamorelin. Theratechnologies has an exclusive license with the MGH to this patent application.
Theratechnologies continues to explore the filing of additional patent applications in the NAFLD/NASH field.
5.2 Disclosure for restructuring transactions
ITEM 6 RELIANCE ON SUBSECTION 7.1(2) OR (3) OF NATIONAL INSTRUMENT 51-102
ITEM 7 OMITTED INFORMATION
ITEM 8 EXECUTIVE OFFICER
For further information, contact Jocelyn Lafond, Vice President, Legal Affairs, and Corporate Secretary of Theratechnologies at (514) 336-7800.
ITEM 9 DATE OF REPORT
September 15, 2020.
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