The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Ed Arce - H.C. Wainwright & Co. - Analyst
: Absolutely. So let's dive in. I know your pipeline lends itself to several different areas of interest. So perhaps for those investors who may not be as
well aware, we could just start with an overview of the company, your strategy, and your pipeline candidates.
Question: Ed Arce - H.C. Wainwright & Co. - Analyst
: Fantastic. Great. All right, so then let's move on to TERN-501, which as you mentioned, is your THR-beta agonist for NASH. What aspects of the
drug's profile differentiated from other agents in the class, especially resmetirom? We'll start with the overview, sort of, of the profile.
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OCTOBER 24, 2023 / 6:30PM, TERN.OQ - Terns Pharmaceuticals Inc at H.C. Wainwright & Co LLC 7th Annual
NASH Investor Conference (Virtual)
Question: Ed Arce - H.C. Wainwright & Co. - Analyst
: Great. All right. So diving in a little bit further into that profile, you have described the aggregate impact of those differentiators you just mentioned
as leading to a best-in-class profile among THR-beta agonists. If you could delineate that profile specifically regarding a little more detail around
some of those areas you mentioned, including PK, the metabolites, and the GI adverse events?
Question: Ed Arce - H.C. Wainwright & Co. - Analyst
: Great. All right. So, as you mentioned, in early August of this year, you reported top-line results in the Phase 2a DUET study. This is the first data set
for TERN-501 in NASH patients. What was the design and the key objectives of that trial?
Question: Ed Arce - H.C. Wainwright & Co. - Analyst
: Great. Okay. So, as you mentioned, the primary endpoint was the relative change in MRI-PDFF at 12 weeks, similar to many other trials before it,
and in this case, both the mid and high dose did achieve statistical significance. Given this demonstrated steatotic activity for 501, how do you
view it in terms of the landscape of other agents?
Question: Ed Arce - H.C. Wainwright & Co. - Analyst
: Okay. So in addition to the strong liver fat reduction we've seen in this trial with 501, in particular at the 6-milligram high dose, it also demonstrated
a statistically significant decrease in corrected T1 of 72 milliseconds, which is a validated biomarker for liver inflammation. So the question is, how
meaningful is this measure in terms of histologic improvement, and how does that compare with other agents in the field?
Question: Ed Arce - H.C. Wainwright & Co. - Analyst
: Okay, continuing with the study reported out a couple months ago, I wanted to ask as well about the statsig improvement, the increase in sex
hormone binding globulin, or SHBG. If you could remind us, what is the significance of that particular biomarker specifically for THR-beta agonists?
Question: Ed Arce - H.C. Wainwright & Co. - Analyst
: Okay, so I also noticed in the data from DUET that consistent with the anti-steatotic activity of the drug, it also demonstrated statistically significant
reduction in the lipids, triglycerides, and ApoB, but only a trend in LDL, and also only a trend in ALT. I'm just wondering if you could describe for
us what you think that really means in terms of the overall profile of the drug.
Question: Ed Arce - H.C. Wainwright & Co. - Analyst
: Okay. So now, according to safety and tolerability from the DUET study, it did show remarkably clean profile overall, in my view. I'm wondering if
you could review the AEs, in particular the GI events that we mentioned earlier, as well as any discontinuations in the study.
Question: Ed Arce - H.C. Wainwright & Co. - Analyst
: Great. And then, as I looked at the baseline characteristics of the study participants, broadly very consistent with prior NASH studies, but one aspect
caught my attention, which is the GLP-1 agonist. There was some use across all the arms, but specifically in the monotherapy arms, which is really
the focus here today, this was well less than 10%. And given the strong rise in the popularity of these agents, I'm wondering if you could describe
how you view the impact of a higher GLP-1 use in future trials on 501's effect size.
Question: Ed Arce - H.C. Wainwright & Co. - Analyst
: Great. And then, I'm wondering what's next for the program. And also, we have ASLD coming up next month, perhaps. Are you ready to reveal
additional data or perhaps the full data set next month?
Question: Ed Arce - H.C. Wainwright & Co. - Analyst
: And then, just in terms of clinical plans going forward, do you intend to meet with the agency or have you already in terms of moving forward on
a regulatory basis?
Question: Ed Arce - H.C. Wainwright & Co. - Analyst
: Right. Okay. A couple last questions, just taking a step back and looking overall for the overall company. As we round out the end of 2023 and look
towards next year, what are some of the key near-term milestones or catalysts that investors could look for?
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OCTOBER 24, 2023 / 6:30PM, TERN.OQ - Terns Pharmaceuticals Inc at H.C. Wainwright & Co LLC 7th Annual
NASH Investor Conference (Virtual)
Question: Ed Arce - H.C. Wainwright & Co. - Analyst
: Excellent. I think we'll stop it there. Jed, again -- sorry, Justin, very much appreciate your time this afternoon and all of your perspectives. Thanks
again.
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