CymaBay Therapeutics, Inc. (NASDAQ:CBAY) Q4 2022 Earnings Call Transcript

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Sujal Shah: So, I think the other part of your question then the second part of it, yes, was around €“ the pros and cons around M&A. First, let me be clear. We’re really building CymaBay to have all of the functional talents and experience to bring this drug to patients ourselves. We are committed to this path forward in PBC as we talked about in some of the prepared remarks. We’re committed to better understanding the effects of seladelpar on the disease even beyond what we know today. And in that path forward, we certainly believe we have not just the internal resources, the relationships with key healthcare providers, but really the balance sheet and investors to allow us to accomplish this objective as we think being able to bring seladelpar to as many patients that may benefit as something we can execute upon ourselves and firmly believe this is the greatest path to creating significant value.

That’s how we think about operating the company. When it pertains to strategic interest, obviously, we have a fiduciary responsibility that we do not ignore recognizing the potential benefits of either partnership or M&A are absolutely always part of our calculus. In terms of partnership, I will at least say this. The Kaken partnership in Japan is one in which we firmly believed it will now accelerate the path forward. This is an area in which there’s additional clinical activities required to bring seladelpar potentially to patients with PBC in Japan. With the balance sheet we have today, with the response study and the overall program that we have today, we think that we have the ability to register seladelpar in the U.S. and potentially in Europe as well on our own.

And we’ll continue to evaluate partnerships, particularly outside the U.S. over time, but we’re in this position where we can execute on the near term objectives here as we get to data. And we’ll think very closely about those alternatives that may present themselves to us thereafter.

Chuck McWherter: Yes. And just to get to your question, Yas, about the outcome or the benefit that we saw in terms of the outreach that we made. We sent team members across North America, Europe, Middle East, even to Asia for the site visits we held, the investigator meetings. The impact of that, Yas, to the enrollment, but also it’s about relationship. It’s €“ we’re able to get feedback real time in terms of the clinical experience that physicians have. And what I think you may be getting at this, what do we think in a qualitative sense this is going to translate into? It’s really, I think increasing the probability of high quality data. We have relationship if there’s findings that need to be discussed, if there’s cleaning and locking the database, being having them be responsive, responding to us, having the ability to reach-out directly to them and importantly, being efficient in the process.

Not letting things drag out. I think that’s really the implications in my mind from having so many different contacts with clinical sites in our study. I think for a rare disease, this is really important.

Yasmeen Rahimi: Thank you so much for all the great color.

Operator: And the next question comes from the line of Steven Seedhouse with Raymond James. Please proceed with your question.

Steven Seedhouse: Great. Thanks for taking the question. It seems to us that in addition to the primary endpoint, there is some secondary effects of the drug, including on pruritus of course where you could really differentiate seladelpar from other competitors market potentially. So, I had a couple of questions about those and I just wanted to, sort of drill down into them. So, the first is just on like the quality of life measures fatigue and sleep disturbance. So, the PBC-40 scoring system, are you measuring these as secondary endpoints? Do you have any expectations for demonstrating improvement on those? And then same question basically for liver function test ALT and AST, is this something you’ll quantitatively look to show benefit on in RESPONSE?

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