Q3 2020 Alpine Immune Sciences Inc Earnings Call
Sales and corporate update conference call.
Operator: Inc. update conference call. Currently, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ask a question at the time, please press STAR, followed by one on your touchtone phone. If anyone has difficulty hearing the conference, please press star zero for operator assistance. As a reminder, this conference is being recorded today, Thursday, November 12, 2012. I would now like to introduce Lawrence Watts, Investor Relations. Please go ahead.
All participants are in a listen only mode. Following management's prepared remarks, we will hold it get any session does take questions at that time. Please press star followed by one on your Touchtone phone if anyone has difficulty hearing the.
Brent Please press star zero for operator assistance as a reminder, this conference is being recorded today Thursday November 12, 2020, I would now like to introduce more and swats investors relations. Please go ahead.
Lawrence Watts: Thank you, Jerome. With me on today's call from Alpine Immune Sciences are Executive Chairman and CEO, Dr. Mitchell Gold, President and Head of Research and Development, Dr. Stanford Peng. Chief Financial Officer Paul Rickey, and Senior Vice President of Business Development and Corporate Strategy Remy Durand. This afternoon, Alpine Immune Sciences issued a press release announcing the company's third quarter 2020 financial results and corporate updates. If you have not received this news release and would like to read it, or you would simply like to be added to the company's distribution list, you can do both on the investor relations page of the company's website at www.alpineimmunesciences.com. During the course of today's conference call, Alpine's management will make forward-looking statements, including but not limited to statements regarding the anticipated impact and timing of the COVID-19 pandemic on Alpine's business, development plans, and timelines and results of operations, the company's preclinical and clinical development plans and the timing thereof, expectations regarding the sufficiency of cash to fund operations, including any cash received from potential milestone payments under Alpine's collaboration, The timing and publication of future clinical data.
Thank you Jerome.
With me on today's call.
Paul from Alpine immune Sciences, our executive Chairman and CEO, Dr. Mitchell Gold President and head of research and development Dr. sample Tang Chief.
Chief Financial Officer, Paul Rickey, and senior Vice President of business development and corporate strategy Remy Durant.
This afternoon Alpine immune sciences issued a press release announcing the companys.
Quarter 2020 financial results and corporate update if you have not received this news release and would like to read it all you would simply like to be added to the company's distribution list you can do both on the Investor Relations page of the company's website at Www Dot Alpine immune Sciences dotcom.
During the course of todays conference call management will make.
Forward looking statements, including but not limited to statements regarding the anticipated impact and timing of the COVID-19 pandemic on alpine business development plans and timelines and results of operations, the company's preclinical and clinical development plans and the timing thereof.
Expectations regarding the sufficiency of cash to fund operations, including any kind.
Cash received from potential milestone payments on the alpine collaborations.
The timing of publication of future clinical data.
Lawrence Watts: Expectations regarding Alpine's ongoing collaborations and potential future collaborations, including the anticipated strategic and financial benefits of the option licensing agreement between Alpine and AbbVie for the development and commercialization of Alpine 101, as well as Alpine's ability to successfully develop its product candidates and achieve milestones under its collaboration with AbbVie and others. Alpine Futures Development Plans, Addressable Market, Regulatory Success, and Commercial Potential of Alpine's or its collaborators' product candidates, and the Financial and Business Outlook for Alpine. These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. Factors that could cause results to be different from those indicated also include factors the company describes in a section entitled Risk Factors in its quarterly report on Form 10-Q, but for a period ending September 30, 2020, and filed with the SEC on or about November 12, 2020. Alpine cautions you not to place undue reliance on forward-looking statements and undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events, or changes in its expectations. With that, I will now turn the call over to Alpine's Executive Chairman and CEO, Dr. Mitchell Gold.
Expectations regarding outlines ongoing collaborations and potential future collaborations, including anticipated strategic and financial benefits of the option in licensing agreement between alpine and Abbvie for the development and commercialization of Alpine one on one.
Mine's ability to successfully develop its product candidates and achieve milestones under its collaboration with Abbvie and others.
I would point you to development plans addressable markets regulatory success and commercial potential of Alpine arts collaborations product candidates and the financial and business outlook for alpine.
These forward looking statements are based on the company's current expectations.
Certainly involve significant risks and uncertainties actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties.
Factors that could cause results to be different from these statements. Also include factors. The company described in the section entitled Risk factors in outlines quarterly report on form.
Hen Q for the period ended September 30, a 2020 and filed with the SEC on or about November 12 2020.
Alpine cautions you not to place undue reliance on forward looking statements on undertakes no duty or obligation to update any forward looking statements as a result of new information future events or changes in its expectations.
With that I will now turn the call over to outlines executive Chairman and CEO Dr. Mitchell gold.
Thanks, Lori and welcome to our third quarter 2020 financial results Conference call.
Mitchell H. Gold: And welcome to our third quarter of 2020 financial results conference call. In the third quarter, we built upon the strong momentum created this year, which included our option and license agreement with AbbVie for worldwide rights to Alpine 101. Advancement of Alpine 202 into the clinic and the completion of an additional financing with top-tier biotech investors through a private placement. As Paul will highlight, these events provide us with a strong balance sheet that allows us to execute on the development of our three promising and diverse programs.
In the third quarter, we both upon the strong momentum created through this year, which included our option and license agreement.
With Abbvie for worldwide rights to alpine one or one.
Advancement of alpine to a to enter the clinic.
And the completion of an additional financing with top tier biotech investors through a private placement.
As Paul will highlight these events provide us with a strong balance sheet.
Allows us to exit.
The development of our three promising and diverse programs.
Mitchell H. Gold: As a reminder, the AbbVie deal provided an upfront payment to Alpine of $60 million, and up to an additional $75 million in potential pre-option payments related to the development of Alpine 101. We continue to invest in our pipeline of novel immunotherapies, including our latest development candidate, Alpine 303, a dual B-cell cytokine antagonist of both BAP and APRIL for the treatment of B-cell-mediated autoimmune and inflammatory diseases We believe that these targets have attracted increasing investor interest and we believe Alpine 303 has a potential best-in-class profile for fusion proteins targeting these B-cell-related pathways. One of the most exciting aspects of the company are the new alpinists we have brought on board. I am confident that they will be significant contributors to our goals, and I'm proud to be on this expedition with a deeply experienced and committed team. With that, I'll now turn the call over to our president and head of R&D, Stanford Peng, to provide a more detailed update on our research and development programs. Stanford?
As a reminder.
The Abbvie deal provided an upfront payment to alpine of $60 million.
Up to an additional $75 million in potential pre option payments related to the development of alpine one on one.
We continue doing.
Invest in our pipeline of novel, if you look there.
About our latest development candidate Alpine Threethree do will be sales cytokine antagonists have both back in April for the treatment of B cell mediated autoimmune and inflammatory diseases.
We believe that these targets have attracted increasing.
That's your interest and we believe our brand through our three as a potential best in class profile for fusion proteins targeting these b cell related pathways.
One of the most exciting aspects of the company or the new Alpinist, we have brought on board.
I'm confident that they will be significant contributors to our goals and our.
Not to be on this expedition with a deeply experienced and committed team.
With that I'll now turn the call over to our president and head of R&D, Stanford paying to provide a more detailed update on our research and development programs Stanford.
Thank you Mitch.
Stanford Peng: As a reminder, ALPN101 is our first-in-class dual inhibitor of the CD28 and IQOS consumatory pathways. We originally developed it for multiple potential autoimmune and inflammatory diseases and are currently focused on systemic lupus erythematosus as part of the AbbVie collaboration. Over the past quarter, we reached an agreement with AbbVie regarding the design of an international safety-focused Phase II study in adults with active lupus. We have successfully received U.S. FDA IND clearance and expect that the study will commence in the first half of next year. AOPIN202 is our first-in-class conditional CD28 co-stimulator and dual-checkpoint inhibitor. We are pleased to report steady progress with NEON1, its first in-human study in advanced malignancies.
As a reminder.
In one on one is our first.
Invest dual inhibitor of the C 28, and icons consumer 20 pathways.
We originally developed it for multiple potential autoimmune and inflammatory diseases and are currently focused on systemic lupus erythematosus as part of the Abbvie collaboration.
Over the past quarter, we have reached an agreement with Abbvie regarding the design of an international safety focused phase twos.
Study in adults with active lupus.
We have successfully received us after R&D clearance and expect.
The study will commence in the first half of next year.
We opened two or two is our first in class conditional see 28, co stimulator and dual checkpoint inhibitor we.
We are pleased to report steady progress with new online.
Its first in human study advancement, we can seize.
Stanford Peng: Following dosing of the first study subject this past June, enrollment and dose escalation have continued steadily. We look forward to future opportunities to provide more substantive updates at the appropriate time and setting once adequate patient experience has been obtained. We anticipate providing a subject update in the first half of next year.
Following dosing of the first study subjects. This past June enrollment and dose escalation has continued to proceed steadily.
Look forward to future opportunities to provide more substantive updates at the appropriate time in setting once adequate patient experience has been obtained.
We anticipate providing study update.
In the first half of next year.
Stanford Peng: Our third development candidate, AOPN303, is a dual BAS-APRIL B-cell cytokine antagonist designed for multiple B-cell-mediated inflammatory diseases. We remain particularly optimistic about this agent in light of continued clinical validation of this pathway by others, especially in diseases such as lupus. In addition, preclinical studies suggest the superiority of ALPN-303 over other available antagonists in this pathway, as we disclosed at the ULAR e-Congress earlier this year. We have initiated formal manufacturing activities and continue to target being ready to enter the clinic by the end of 2021. I'll now hand the call over to our CFO, Paul Rickey, to discuss our financial results for the quarter.
Our third development candidate LPN three or three is a dual bath April b cell cytokine antagonist designed for multiple b cell mediated inflammatory diseases.
We remain particularly optimistic about this agent bite of continued clinical validation of this pathway by others, especially in diseases such as lupus.
In addition, preclinical studies suggest superiority of LTM three or three over other available antagonists in this pathway as we disclosed that the U.R.E. Congress earlier this year.
We have initiated formal manufacturing activities and continue to target being ready to enter the clinic by the end of 2021.
I'll now hand, the call over to our CEO.
So Paul Rickey to discuss our financial results in the quarter call.
Paul Rickey: Thank you, Stanford. Turning to our financial results for the third quarter, Alpine's cash, cash equivalents, and marketable securities totaled $141.3 million as of September 30, 2020. This compares to our balance of $90.5 million as of June 30, 2020. Revenue recognized under our collaboration agreements was approximately $1.9 million in the third quarter of 2020, which primarily relates to our recent collaboration with AbbVie compared to approximately $300,000 recognized in the third quarter of the prior year. Research and development expenses for the third quarter of 2020 were $6.2 million compared to $9.5 million for the third quarter of last year. The change primarily relates to higher prior year costs to cover our Healthy Volunteer Study for Alpine 101 and the manufacturing of drug products for Alpine 202, offset in the current quarter with costs for our NEOM1 study.
Thank you Stanford turning to our financial results for the third quarter Alpine is cash cash equivalents and marketable securities totaled $141.3 million as of September 32020. This compares to our balance of $90.5 million.
As of June 32020.
Revenue recognized under our collaboration agreements was approximately $1.9 million in the third quarter of 2020, which primarily relates to our recent collaboration with Abbvie compared to approximately 300000 recognized in the third quarter of the prior year.
Research and development.
<unk> expenses for the third quarter of 2020 were $6.2 million compared to $9.5 million for the third quarter last year. The change primarily relates to a higher prior year costs to cover our healthy volunteer study for Alpine 101, and the manufacturing of drug product for alpine to offset in the current quarter with cost.
For our neon one study.
Paul Rickey: General and administrative expenses for the third quarter of 2020 were $2.7 million compared to $2.5 million for the third quarter last year, staying relatively flat. Alpine recorded a net loss of $6.1 million this quarter compared to $11.5 million for the third quarter of 2019. In terms of our cash runway, we expect that our cash on hand, combined with the potential $75 million in pre-option exercise milestones under our collaboration with Avni, will be sufficient to fund Alpine's planned operations into 2024. With that, I will turn the call back to Mitch.
General and administrative expenses for the third quarter of 2020 or $2.7 million compared to $2.5 million for the third quarter last year staying relatively flat.
Alpine recorded a net loss of 6.1 million this quarter compared to $11.5 million for the third quarter.
Well 2019.
In terms of our cash runway, we expect that our cash on hand, combined with the potential $75 million in pre option exercise milestones under our collaboration with Abbvie are sufficient to fund our planned planned operations into 2024.
With that I will turn the call back to Mitch.
Mitchell H. Gold: Thanks, Paul. It's been a transformative year for the company, and I'm delighted with the momentum we are building it up. Now that we have early clinical validation of our directed evolution platform and formed a meaningful partnership with AbbVie, we believe the best is ahead of us as we look to transform the treatment of debilitating diseases. We look forward to keeping you updated on our progress toward that goal. With that, we'll now open the phones for questions.
Thanks, Paul.
It's been a transformative year for the company and I'm delighted with momentum we are building it out.
Now that we have early clinical validation of our directed evolution platform and for new meaningful partnership with Abbvie. We believe the best is ahead of US as we look to transform the treatment of debilitating diseases.
We look forward to keeping you updated on our progress toward that goal with that we'll now open the phones for questions.
Operator: Thank you. Thank you. I would now like to remind everyone, in order to ask a question, please press star, then the number 1 on your telephone keypad. We have a question coming from the line of Boris Peter from Cohen. Your line is now open.
Operator, thank you.
Thank you I would now like to remind everyone in order to ask a question. Please press Star then the number one on your telephone keypad.
We have a question coming from.
On line up very speaker from Cowen Your line is now open.
Boris Peter: Great. I'd like to start, maybe with 202. Can you just comment on what specific patients you're trying to enroll in the NEON1 study? Sure.
Great I'd like to start maybe with tour to change his comment what specific patients you are trying to enroll in the knee on one study.
Sure Stan for do you want to take the first part of that and maybe I'll chime in again.
Mitchell H. Gold: Sure. Stanford, do you want to take the first part of that, and then maybe I'll chime in at the end?
Stanford Peng: Sure, it's actually an all-comers study, but patients who have failed all available, currently available, standard therapy options. So that would include patients that have failed checkpoint inhibitors where indicated, but also, hopefully, indications that are resistant to checkpoint inhibitors.
Sure.
It's actually an all comers study, but patients who have sales all available.
Currently they currently available standard therapy option. So that would include patients that have failed checkpoint inhibitors where indicated.
But also hopefully indications that are.
Resistant to checkpoint inhibitors.
Just a reminder book.
Mitchell H. Gold: Just a reminder, Boris, we're still in the dose escalation portion of the study, and obviously, as we see signals, we'll go into expansion cohorts after that.
We're still in the dose escalation portion of the study and obviously as we see signals will go into expansion cohorts after that.
Gotcha is there any thoughts at least at the early stages, now, which indications maybe more suitable for neon ongoing empowered.
Mitchell H. Gold: Is there any indication, at least at the early stages now, which indications may be more suitable for NEON 1 going forward?
Stanford Peng: Well, you know, I think it's still too early to say. We're moving steadily through the dose escalation cohorts, and I think we're pleased with what we're seeing, but I think it's still too early for us to say which patient population could potentially benefit most from 202.
I think it's still too early.
To say you know we are moving steadily through the dose escalation cohorts and I think we're pleased with what we're seeing but I think it's still too early for us to say, which patient population could potentially benefit most from too.
Mitchell H. Gold: And maybe lastly, on 303, just kind of a high-level question, how is this molecule differentiated from other B-cell targeting molecules in autoimmune diseases-approved things like Benlista and Teletelecept and maybe even 101 itself?
And maybe lastly on covering all three.
Just kind of maybe a high level question. How is this molecule differentiated from other.
Ill targeting molecules in autoimmune diseases approved things like Benlysta and tell the telesat.
And maybe even 101 itself.
Stanford Peng: For sure. Stanford, do you want to take this?
For sure Stanford you want to take that.
Stanford Peng: So those are three different molecules you mentioned, and I'll go through each of them. Benlista is a monoclonal antibody that targets BAS and only BAS, whereas AOPN303 targets both APRIL and BAS, which are two B-cell cytokines that bind to three B-cell receptors. So the major differentiation point of molecules that are derived from tachy like 303 is that they also get this second cytokine, APRIL, whereas Benlista only addresses BAS. Teletachycept does also hit APRIL in addition to BAS.
Yes. So those are three different molecules you mentioned it I'll go through each of them. So benlysta is a monoclonal antibody that targets Bath.
And only bass, whereas.
Okay, three or three targets, both April and bass, which are too.
B cell set of clients that buying to three.
Diesel receptors. So the major differentiation point of molecules that are derived from tacky is like three or three is that they also get the second cytokine April whereas.
President list only addresses Bath Teletech, except does also hit people in addition to bass however.
Stanford Peng: However, we've engineered our molecule to be more potent, we think, than teletachycept. So that was some of the data that we alluded to at ULAR, which in vitro as well as in vivo, in preclinical models, we see superiority over wild-type versions of tachy-EFC. Alpine 101 is more of a T-cell directed co-stimulatory agent. It addresses and binds to CD28 and IQOS, which are both T-cell-directed co-stimulatory proteins. Presumatory Receptors, and in contrast, 303, as well as Teletracusept and Benlista, address B-cell cytokines. Thus, they affect different parts of the immune system.
However, we've engineered our molecule to be more potent. We think then teletech is up so that was some of the data that we alluded to at EULAR.
Which in vitro as well as in vivo.
In preclinical models, we see superiority over well type versions of Techie FC.
In one on one appears is more of a T cell directed co stimulatory.
Agent it addresses and binds to see 28, and Ipos, which are both T cell.
So stimulatory receptors on in contrast, three.
Three or three as well as Teletech aseptic and Benlysta.
Address b cell cytokine, so they address different parts of the immune system.
Mitchell H. Gold: Great, thank you for the answers to my questions.
Great. Thank you for the answers to my questions.
Operator: And Boris, as you hop off, just to remind you, I think, as I mentioned in my prepared comments, there's been more and more investor interest focusing on targeting both FAF and APHOS. You know, one of the largest IPOs in biotech just went off this week. And so, as Stanford mentioned, we believe we have a best-in-class product profile going there, and as we move that into the clinic next year, we expect that to provide meaningful upside for the company. Next question.
In bars as you have just remind you I think as I mentioned in my prepared comments, there has been more and more investor interest focusing on targeting.
Getting both Bath and April you know one of the largest ipos and biotech just went up this.
This week and so at Stanford mentioned, we believe we have a best in class product profile going there and as we move that in the clinic next year, we expect that to provide meaningful upside to the company.
Next question.
Thank you your next.
Lessons thoughts from their lineup, Mike buy them back from Oppenheimer. Your line is now open.
Operator: Thank you. Your next question comes from the line up, Mark Beidenbeck from Oppenheimer. Your line is now open.
Hey, good afternoon, guys and thanks for taking my questions.
I think I heard Sanford C. that the I. Andy has been cleared for the phase two study in actually I'm. Just wondering if you can tell us anything more about that.
Mark Beidenbeck: Hey, good afternoon, guys, and thanks for taking my questions. I think I heard Stanford say that the IND has been cleared for the Phase 2 study in SLE. I'm just wondering if you can tell us anything more about the study design. Could it look something like Remigen's randomized Phase 2B of teletasciseptin in SLE in terms of trial size and endpoints and things like that?
Redesign.
Couldn't look something like Remingtons randomized phase two b.
I'd tell you that's assessed it necessarily in terms of trial size and endpoints and things like that yeah.
Hi, Marco lets damper take that for you.
Stanford Peng: Yeah. Hi Mark. I love Stanford. Take that for me. Sure.
Sure.
Sure. So it's.
So it is a randomized parallel arm double blind placebo controlled trial.
Stanford Peng: Sure, so it is a randomized, parallel arm, double-blind, placebo-controlled trial. We'd like to wait before disclosing a lot more further details, since there are other regulatory filings that we'll need to do, and we do anticipate it to be a multinational study and don't yet have feedback from some of the other areas. But in general, we can say right now that what we've agreed upon with AbbVie is a safety-focused study looking at standard endpoints in a lupus trial.
We'd like to wait before disclosing a lot more further details and there are other regulatory filings that will need to do it we do anticipate to be a multinational study.
And don't yet have feedback from some of the other areas but.
In general it's a week.
We can say right now what we've agreed upon with Abbvie as a safety.
Safety focus study.
Looking at you know standard endpoints lupus trial.
Stanford Peng: Got it, got it. And in terms of, um, upcoming data from neon one, it might be too early to provide any guidance, but can you give us any hints as to how many patients and dose levels you hope to include in the first cut? And just remind me, there's no paired biopsy analysis or tissue biomarker analysis included in the dose escalating cohorts, right?
Got it got it.
And then in terms of.
Upcoming data from me.
On one.
It might be too early to provide any guidance, but you can't give us any sense as to how many patients.
Dose levels, you hope to including the first cut and just remind me there's no paired biopsies analysis or tissue biomarker analysis included in the dose escalation cohorts right.
Stanford Peng: Yeah, Stanford, you want to take it, and then I'll kind of add on.
As Dan for you want to take it and then I'll kind of add on.
Yes, so we.
Stanford Peng: Yeah, so we do have, we do, we are looking at baseline tumor biopsies for a number of different potential biomarkers of response to AOPN202. However, during escalation, we've made biopsies optional in the study.
We do have we do we are looking at baseline tumor biopsies or a number of different potential biomarkers of response to open two or two during escalation weve made biopsies optional on study.
Stanford Peng: But that, you know, is to be discussed as we move into expansion cohorts and other further analyses. I would say, you know, in terms of the number of subjects we hope to see, that kind of depends on what kind of safety and or efficacy findings we make and also in what particular disease types. Since, as you know, in different tumor types, you may, we may need larger numbers of patients to be able to draw definitive conclusions. So I'm afraid it's a little wishy-washy, but it, you know, because we're enrolling multiple types of tumors, it's kind of hard to predict right now based on what we're seeing.
But that.
Is to be discussed as we move into expansion cohorts and other further analyses.
I would say.
In terms of the number of subjects, we hope to see that kind of depends on what kind of.
Safety and or efficacy findings, we make and also in what particular disease.
Type some since as you know and in different tumor types Youve made we may need larger.
Larger numbers of patients to draw definitive conclusions I thought.
Great. It's a little Wishy washy, but because were enrolling multiple types of tumors, it's kind of hard to predict right now based on what we've seen.
But one thing I can tell you markers.
Mitchell H. Gold: One thing I can tell you, Mark, is that we're moving very steadily through our dose escalation cohorts. We have not seen any DLTs to date, and we're pleased with what we're seeing. Our pharmacodynamic analysis has been very consistent with what we predicted pre-clinically, and even though it's a small number of patients, we are seeing some evidence of pharmacologic activity, but it's way too early to make any conclusions from that.
We're moving very steadily through our dose escalation cohorts, we have not seen.
Seen any deal Tees to date.
And we're pleased with what we're seeing our pharmaco.
Pharmacodynamic analysis had been very consistent with what we predicted preclinically.
And even though it's a small number of patients we are seeing some evidence of pharmacologic activity.
But it's it's way too early to make any conclusions from that.
Mark Beidenbeck: Okay, got it. And maybe just one last quick sciencey one for Stanford. Stanford, can you remind us if Alpine 303 shares the same type of SC domain as Teletestisept and or Benlista, or is it different from those two?
Okay got it and maybe just one last quick sorry in Q1 for Stanford.
Sales for key remind us if you are.
Alpine three or three shares the same type of FC domain as a totally Texas outdoor and indoor benlysta or is.
Different some of those too.
Stanford Peng: Well, it's not like Benlista since Benlista is a monoclonal antibody. However, for Teleteq, the problem is that we don't actually know what the structure of their FC is. In the public documents, we've seen it's stated to be an IgG-derived FC, but whether it's an IgG1 or an IgG4, et cetera, I don't know. At least, I haven't been able to identify it definitively.
Well, it's not like then lift business and this is a monoclonal antibody.
However for Teletech is said, we don't actually know what the structure of their FC is publicly in the public documents. We've seen it stated to be a IBG derived SC that.
Whether it's an idea you won or actually for.
Et cetera, where we don't have I don't know.
At least that haven't been slight definitively yes.
Mark Beidenbeck: Okay, I think Benliss is an IgG1, but I could be wrong, but I was just kidding. Thanks for taking the call.
Okay. I think then listen I'll give you one.
I could be wrong, but.
I was just curious.
Thanks.
Operator: Thanks, Mark. Thank you. Your next question comes from the line of Ted Bento from Piper Sandler. Your line is now open.
The questions.
Thanks Mark.
Thank you. Your next question comes from the line up that Ben <unk> from Piper Sandler Airlines know Ben Great.
Ted Bento: Great. Thanks, guys. Thanks for the update.
Great. Thanks, Thanks for the update lots of questions answered.
Mitchell H. Gold: Lots of questions answered. Mitch, I'm going to ask you to kind of get your and Stanford's opinion sort of of what this... Cash Infusion and partnership with AbbVie do for the company at a higher level. Obviously, you've got a lot of exciting compounds here, a lot of work to do, a lot of clinical progress, but what does this really do in terms of transforming the company and allowing it to broaden and expand the pipeline? Thanks.
If someone does that help.
Get Europe, and sanford's opinion sort of what.
The.
Cash infusion in partnership with up to you does for the company at a higher level, obviously, you've got a lot of excited compounds here a lot of work to do a lot of clinical progress, but what does this really do in terms of transforming the company enabled to broaden and expand the pipe.
Thanks, Yeah.
Mitchell H. Gold: Yeah. Hi Ted.
Yeah, Hi, David Thanks for the question it really it's very transformative for us on a number of different levels. One it allows us to execute on our two ongoing clinical programs and then bring alpine through a degree into the clinic on around really can get meaningful data from that but it really as I mentioned in my prepared comments brought.
Mitchell H. Gold: And thanks for the question. It really is very transformative for us on a number of different levels. One, it allows us to execute on our two ongoing clinical programs and then bring Alpine 303 into the clinic on our own where we can get meaningful data from that. But it really, as I mentioned in my prepared comments, brought in a whole group of people into the company that are really top tier and allows us to invest in our discovery pipeline, which we're very excited about. We know that this platform, this directed evolution platform, can be very productive since it's already spun off three programs from it. And with Alpine 101, we've seen early signs of clinical validation. I think we're pretty excited about what the future holds for the platform coming out of our discovery pipeline. What I would guide you to is, you know, we have two programs already in autoimmune and inflammation. I think you should expect the next program to come out of our discovery platform will be focused on the I.O. front.
The whole group of people into the company that are really top tier and and allows us to invest in our discovery pipeline, which we're very excited about we know that this platform. This directed evolution platform can be very productive since its already spun off three programs from a NIM without min 101, we've seen early signs of clinical validation I think were pretty.
And I'll say it about what the future holds for the platform kind of coming out of our discovery pipeline. What I would guide you towards is you know we have two programs are ready not admitted information I think you should expect the next program to come out of our discovery platform will be focused on in the Io front.
Good.
Very helpful. Thanks, so much.
Ted Bento: Great, Mitch, that's super helpful. Thanks so much.
Do you think that.
Thank you. Your next question comes from the line of Robert Recycle from Wedbush Securities. Your line is now open.
Ted Bento: Thanks, Ted.
Operator: Thank you. Your next question comes from the line of Robert Driscoll from Red Bush Securities. Your line is now open.
Hi, there.
People bark offer up just a quick final question.
Well there are milestones.
Associated with the.
The.
Hi, Andy clearance or maybe what are the next couple of points.
Robert Driscoll: Hi guys, this is Ashik Mubarak from On4Off. Just a quick finance question. Was there a milestone payment from AbbVie associated with the R&D?
Well I, probably would have been a disclosable event. So what we've said publicly so far is there $75 million in pre option milestone payments.
Operator: Well, I probably would have.
They are divided roughly equally.
Operator: Event. So what we've got...
Stanford mentioned you know the U.S.
Operator: [inaudible] Yeah, okay, thank you.
Hi, Andy has.
Has been cleared and we expect enrollment to begin in the first half of next year and beyond that we're not going to comment other than when we when we trigger or hit the milestones that will make that publicly known.
Operator: Thank you. Your next question comes from the line at Gwangji-ri in Ladenburg. Your line is now open.
Okay. Thank you.
Thank you. Your next question comes from the line of brands is Lee from Ladenburg.
Gwangji-ri: Hi. Thanks for taking my question. It's great to hear Mitch mention the NIR1 trial going well so far. And I'm just wondering, could you remind me, is the trial a 3 plus 3 design, and are you allowed to enroll patients simultaneously for the same cohort, or do you need some kind of sequential enrollment or waiting period given the history of the CD28 Agonist trial? Yeah, Stanford, do you want to take that?
It is now open.
Hi, Thanks for taking my question.
Good to hear Mitch mentioned, the Neal one.
Got you well so far and just wondering could you remind me is the trials Threed plus we design into can you allowed to rollout a allowed it to digital patient summit.
Continuously for the San cohorts, we needed some kind of sequential your aluminum a waiting period, given the history of the Cdtwenty goodness.
No.
Yes.
Do you want to take that.
Stanford Peng: Yeah, so it's an accelerated titration design in the first few cohorts and then changes to a three plus three design. So the accelerated titration is to get us out of the theoretically low dose, you know, the theoretically non-pharmacologically active dose ranges and then allow us to explore in a traditional three plus three design at levels that we expect to have some type of pharmacodynamic activity.
Yes, so it's a it's an accelerated penetration design in the first few cohorts and then change.
Changes to a three plus three so the XL repatriation is to get us out of the.
Theoretically low dose that directly non pharmacologically active dose ranges.
And then allow us to.
Explore in a traditional three plus three design and levels that we expect to have some type of pharmacodynamic activity.
It.
Yes. So ended this week three plus three cohorts you allow to new patients some opinions me.
Gwangji-ri: So out of the three plus three cohorts, are you allowed to interview patients simultaneously?
Stanford Peng: Well, we're doing us. We are doing sentinel dosing during our cohorts, but the actual strategy of sentinel dosing varies from cohort to cohort.
Well, we're doing is we're doing we're doing sentinel dosing during our cohorts.
The actual strategy of the Sentinel dosing varies from quarter to quarter.
Gwangji-ri: Okay, that's helpful. And then my last question is for 303. Could you remind me the timing for IND?
Okay. That's helpful. And then my last question you pose real Sthree.
Could you remind me the timing for I'd.
Yes.
Stanford Peng: Yes, we're pretty excited about that, and we're putting significant resources behind that program for a lot of our IND enabling work, but we're guiding towards an IND in Q4 of next year.
We're pretty excited about that are putting significant resources behind that program for a lot of our I'd, enabling work, but we're guiding towards 90 in Q4 of next year.
Gwangji-ri: Thank you for taking my questions.
Your next year, Okay. That's great. Thank you for taking my questions. Thanks, Wamsi I appreciate you getting on.
Operator: Thanks, Lingzi. Appreciate you getting on.
Mitchell H. Gold: Thank you. There are no further questions at this time. I would now like to turn the call over to Mitchell Gold.
Thank you there are no further questions at this time I would now like to turn the call over back to reach our goal.
Operator: Thank you. I just want to thank everyone for making time today, and we look forward to meeting with many of you over the phone or via Zoom to give you updates on the company. We're very, very pleased with the progress that we've made over the last year or so. Thanks very much, and have a great day.
Thank you I just wanted to thank everyone for making time today and we look forward to meeting with many of you over the phone or over resuming.
Let me give you updates on the company, we're very very pleased with the progress that we've made over the last year. So thanks, very much and have a great day.
Operator: This concludes today's conference call. You may now disconnect. Thank you.
This concludes today's conference call you may now disconnect. Thank you.
Operator: Thank you.
Operator: [inaudible]
Operator: Physicist, Dr. James Tumlin, Robert Driscoll, Alpine Immune, Michael Ulz, Jonathan Barratt, Michael Ulz, Alpine Immune, Dr. James Tumlin, Robert Driscoll, Alpine Immune, Michael Ulz,
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