Theratechnologies Inc T.TH

Alternate Symbol(s): THTX

Healthcare Biotechnology

Theratechnologies Inc. is a Canada-based clinical-stage biopharmaceutical company. The Company is focused on the development and commercialization of therapies addressing unmet medical needs. It markets prescription products for people with human immunodeficiency viruses (HIV) in the United States. The Company's research pipeline focuses on specialized therapies addressing unmet medical needs in HIV, nonalcoholic steatohepatitis (NASH) and oncology. Its medicines include Trogarzo and EGRIFTA SV (tesamorelin for injection). Trogarzo (ibalizumab-uiyk) injection is a long-acting monoclonal antibody which binds to domain 2 of the CD4 T cell receptors. EGRIFTA SV (tesamorelin for injection) is approved in the United States for the reduction of excess abdominal fat in people with HIV who have lipodystrophy. Its portfolio includes Phase I clinical trial of sudocetaxel zendusortide (TH1902), a novel peptide-drug conjugate (PDC), in patients with advanced ovarian cancer.

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Theratechnologies Inc > Does TH already know the drug works?

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Comment by jeffm34on Nov 02, 2021 3:43pm

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Post# 34078893

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Does TH already know the drug works?

Its not POC. It's payable if they decide to continue development based on phase 1 results.

Third Installment, is payable upon our decision to pursue the development of the peptide studied in the phase I clinical trial if the results of such study warrant the pursuit of its development.

SPCEO1 wrote: Was there anything in there that defined PoC? OR is there just some generally accepted defintion that would allow them to say it had been reached and a payment needed to be made?

palinc2000 wrote:
The milestone payment related to Proof of Concept is very small ......

Theratechnologies will acquire all outstanding shares of Katana for US$5,300,000 or CA$6,900,000. Approximately US$2,000,000, or CA$2,600,000, was paid in cash at closing. Katana shareholders will have the right to receive two milestone payments. The first milestone payment will occur when the first patient for the proof of concept trial is enrolled. At that time, approximately US$1,500,000 will be paid through the issuance of common shares of Theratechnologies.

The second milestone will be met when the proof of concept is demonstrated in human subjects, which should be by the end of 2021. This payment will amount to US$1,800,000 in common shares of Theratechnologies.

palinc2000 wrote: I think there is a milestone payment to the former shareholders of Katana upon reaching PoC
So that would mean that POC is defined in the purchase contract,,,I dont recall if the doc is available on Sedar ....I will look for it

qwerty22 wrote:
That's clearer than me but what I'd add is what it doesn't do.

It doesn't guarantee clinical value or financial value (yet). With strong signals it might be an indicator for the next tranche of questions.

JayjayUSA12007 wrote:
Quote:"How is proof of concept defined? What exactly do we need to see to determine that proof of concept has been achieved?"

First, MTD should be around 3x to 5x normal chemo dose.
Second, during this treatment, if docetacel could be observed to be of high intracellular around 7x to 10x as showed in preclinical trial.(primary endpoints)
Third, if, during or after trial, tumors are obversed to shrink (secondary endpoints)
Fourth, if, after trial, metastasis could be stopped.(secondary endpoints)

Then, proof of concept will be proved.