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: Eun Yang - Jefferies LLC - Analyst
: Thank you. Can you hear me okay?
Question: Eun Yang - Jefferies LLC - Analyst
: Thank you. So question is on 0310. It's a very interesting product for a wide range of indications. But the indications that you are looking at are
pretty large. So I want to ask you about your medium- to long-term plan with the product, how you are thinking about developing the product to
market. Is that something that you would be interested in partnering at some point?
And then second question is, given that there are two same mechanism of action drug is in late stage of development, how important it is for you
to see improved or better efficacy aside from less frequent dosing? And the last question is, it's just more of a housekeeping question, $15 million
upfront payment, is that going to be booked at once in R&D in fourth quarter? And the clinical development milestone seems to be minimal, about
$20 million. But can you comment on your R&D spending for this year as well as next year? Thank you.
Question: Eun Yang - Jefferies LLC - Analyst
: Thank you.
Question: Farhana Sakloth - Ladenburg Thalmann & Co. Inc. - Analyst
: Hey, guys. Good morning and congratulations, a few questions from us. Will you provide any updates on the preclinical activity of 0310 over the
next year or so? Also how many other compounds are there in the OX40 portfolio? And then following on the first question was, the preclinical
data that you showed up today was without the YTE modification. So when might we see additional data with YTE? And just another question on
the deal terms is, what are the specified circumstances under which there can be a reduction in royalties?
Question: Farhana Sakloth - Ladenburg Thalmann & Co. Inc. - Analyst
: Great, thank you so much.
Question: Hartaj Singh - Oppenheimer & Co., Inc. - Analyst
: Great, can you hear me?
Question: Hartaj Singh - Oppenheimer & Co., Inc. - Analyst
: Great, thank you. Congratulations, everyone. And good morning. Thanks for moving our slow October to a fast October, really nice in-license here.
Just a couple of quick questions, most of my questions have actually been answered.
On 0310, as you've outlined what you're thinking and, Jill, the milestones, can you just talk a little bit about -- over the next year and half, as you're
getting the preclinical data, you're preparing for an IND by the end of next year, how are you thinking specifically of your clinical strategy? I mean,
would it be target patients that are hard to treat, maybe smaller Phase 2s and 3s, and then trying to get to market that way? Is that possible in this
market, atopic dermatitis? Would you need larger trials or is this all to be determined? And then I have a quick follow-up question on 0215 after
this.
Question: Hartaj Singh - Oppenheimer & Co., Inc. - Analyst
: Yeah, Chris, that helps a lot. Thank you so much. And then just on 0215, I know it's a 0310 call, but just had to ask this question. Christian, you
mentioned that you'll start one Phase 3. Is that the expectation right now, that between your early to mid-stage programs, one Phase 3 and the
open-label extension, ALPHA-SOLAR, that you could have enough of a database to file with the FDA, assuming everything is positive?
Question: Hartaj Singh - Oppenheimer & Co., Inc. - Analyst
: Great, thank you for the questions.
Question: Unidentified Participant - Wedbush Securities Inc. - Analyst
: Hi, thanks, this is Ingrid. I'm for Laura Chico. Just one question from us, can you just speak further in terms of the timing of the licensing deal and
why it makes sense ahead of potential pivotal STAR-0215 efforts?
Question: Unidentified Participant - Wedbush Securities Inc. - Analyst
: Thank you.
Question: Rami Katkhuda - LifeSci Capital LLC - Analyst
: Hey, guys, this is Rami on for Sam Slutsky. Thanks for taking our questions. I guess given the validation of both the antibody technology for STAR-0310
and OX40 antagonism in atopic derm in general, is there a potential to accelerate the development timelines here versus a traditional Phase 2, 3?
Question: Rami Katkhuda - LifeSci Capital LLC - Analyst
: Got it. And then really quickly, given what we know about the YTE half-life extension tech, are there specific nuances to consider on OX40 as a
target for whether STAR-0310 would be administered as every two months versus every three months?
Question: Rami Katkhuda - LifeSci Capital LLC - Analyst
: Got it. Thank you, guys. And congrats again.
Question: Liisa Bayko - Evercore ISI Institutional Equities - Analyst
: Hi, guys. Congratulations on the deal. And my first question is on your new program. I'm just wondering why targeting OX40 ligand versus OX40
receptor, why is there a difference in potential safety?
Question: Liisa Bayko - Evercore ISI Institutional Equities - Analyst
: Okay, great, and for STAR-0215, can you maybe just highlight what you're hoping to learn and share with the street when the next phase 1 data
results come out later in the fourth quarter?
Question: Liisa Bayko - Evercore ISI Institutional Equities - Analyst
: Okay, great, and will that highlight the potential for every six-month dosing, is that part of that?
Question: Liisa Bayko - Evercore ISI Institutional Equities - Analyst
: When you think about those two dosing strategies, how confident you are in the every six-month dosing versus every three? Where does your --
I know base case is every three months, but just curious on the potential for every six months.
Question: Liisa Bayko - Evercore ISI Institutional Equities - Analyst
: Okay, great. Thank you.
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