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
December 12, 2022
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 December 12, 2022|
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.
|Name: Jocelyn Lafond|
|Title: General Counsel|
Date: December 12, 2022
MATERIAL CHANGE REPORT
ITEM 1 - NAME AND ADDRESS OF COMPANY
THERATECHNOLOGIES INC. (the Corporation)
2015 Peel Street
Canada H3A 1T8
ITEM 2 - DATE OF MATERIAL CHANGE
December 1, 2022.
ITEM 3 - NEWS RELEASE
A news release describing this material change was issued by the Corporation on December 1, 2022 via GLOBE NEWSWIRE. A copy of the news release is available on the SEDAR website at www.sedar.com and on the EDGAR website at www.sec.gov/edgar as an attachment to a Form 6-K dated December 2, 2022.
ITEM 4 - SUMMARY OF MATERIAL CHANGE
On December 1, 2022, the Corporation announced that it decided to pause the enrollment of patients in its Phase 1 clinical trial of TH1902, the Corporations lead investigational peptide drug conjugate (PDC) for the treatment of sortilin-expressing cancers. The Corporation also announced that it planned on submitting an amendment to its protocol to the U.S. Food and Drug Administration (FDA) for approval.
ITEM 5 - FULL DESCRIPTION OF MATERIAL CHANGE
On December 1, 2022, the Corporation announced that it decided to pause the enrollment of patients in its Phase 1 clinical trial of TH1902, the Corporations lead investigational PDC for the treatment of sortilin-expressing cancers. The Corporation also announced that it planned on submitting an amendment to its protocol to the FDA for approval.
The Corporation voluntarily made the decision to pause enrollment and revisit the study design after consulting with its investigators. Efficacy results observed thus far were not convincing enough to pursue enrolling patients and did not outweigh the adverse events seen in some patients. As previously reported, these adverse events consist mainly of neuropathy and eye toxicity.
The current intent for the protocol amendment is to modify the dosage regimen to optimize the delivery of TH1902, with lower doses at more frequent intervals. The Corporation continues to investigate the results obtained thus far in the Phase 1 clinical trial.
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, General Counsel and Corporate Secretary of the Corporation at (438) 315-6607.
ITEM 9 - DATE OF REPORT
December 12, 2022.
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