This is the small print Forward Looking Info (FLI) from the June corporate presentation:
Certain assumptions made in preparing the FLI include, but are not limited to, the following:
•
•(1) Global trade and supply issues will have limited adverse effects on our activities and
business plan;
•
•(2) sales of EGRIFTA SV ® and Trogarzo ® will continue to grow in the United States;
•
•(3) the known safety and efficacy profile of EGRIFTA SV ® and Trogarzo ® will not change as a
result of their long term use;
•
•(4) the FDA will approve the sBLA related to the IV Push mode of administration of Trogarzo ®
•
•(5) the FDA will approve the F8 formulation of tesamorelin , once an sBLA has been filed;
•
•(6) we will succeed in developing a multi dose injection pen using the F8 formulation and
regulatory agencies will approve same;
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•(7) no biosimilar version of EGRIFTA SV ® will be approved by the FDA;
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•(8) we will be able to secure additional resources to initiate our Phase 3 clinical trial evaluating
tesamorelin for the treatment of NASH, including finding a partner
•
•(9) the totality of evidence and data resulting from the conduct of our planned Phase 2b/3
clinical trial evaluating tesamorelin for the treatment of NASH will demonstrate substantial
evidence of efficacy and will be highly persuasive to regulatory agencies in order to gain
approval;
•
•(10) we will obtain positive results from our Phase 1 clinical trial evaluating TH1902 for the
treatment of various cancers; and,
•
•(11) we will meet all of the timelines set forth in this presentation.
And this is the same thing from the July presentation:
Certain assumptions made in preparing the FLI include, but are not limited to, the following:
•
•(1) sales of EGRIFTA SV ® and Trogarzo ® will continue to grow;
•
•(2) the known safety and efficacy profile of EGRIFTA SV ® and Trogarzo ® will not change as a
result of their long term use;
•
•(3) we will meet all of the timelines set forth in this presentation and related thereto;
•
•(4) we will meet all of the terms and conditions of the credit facility agreement to be able to
draw down on each loan facility tranche available thereunder;
•
•(5) no biosimilar versions of EGRIFTA SV ® will be approved by the FDA;
•
•(6) we will be able to continue the recruitment of patients to conduct the Phase 1 clinical trial in
oncology;
•
•(7) we will obtain positive results from our Phase 1 clinical trial evaluating TH1902 for the
treatment of various cancers;
•
•(8) we will be able to s ecure additional resources to initiate our Phase 3 clinical trial evaluating
tesamorelin for the treatment of NASH, including finding a partner with resources and
capabilities;
•
•(9) the IV push mode of administration for Trogarzo ® will be approved by the FDA;
•
•(10) our 2022 business strategies will not change.
So, any reference to the F8 was dropped. Global trade and supply issues was dropped too. New loan info was added as was the risk of not being able to recruit patients for the phase 1b. Point 9 in the June presentation regarding NASH was also dropped which indicated they thought the evidence for NASH would be highly persusive to the FDA.
Also, the last point on the fourth and final slide in the NASH section was changed - the interest in non-dilutuve financing was removed. So, TH is no longer looking to finance NASH via any kind of financing other than from a partner. Since I really do not think this is going to happen due to patent concerns (I suspect they are not strong enough and not long enough to suit most potential partners), NASH is a real long shot at this point. If TH sees good cancer data in phase 1a and moves into phase 2, I suspect they will drop any mention of NASH at that time as it really seems less realistic as each day passes and these changes in the presentation highlight that.
Iam a little concerned about the references to the F8 formulation being dropped as we would all like to see that developed and used for lipodystrophy but perhaps it does not make economic sense if it is not going to be used for NASH too?