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spk03: Welcome to the Alpine Immune Sciences fourth quarter 2022 earnings call. Currently, all participants are in listen-only mode. As a reminder, this event is being recorded. I would now like to introduce Temri Johnson, Senior Director of Investor Relations and Corporate Communications at Alpine. Ms. Johnson, I'll now turn the call over to you.
spk01: Thank you, Terri. Good afternoon, and thank you for joining us. With me on the call today are Dr. Mitchell Gold, Executive Chairman and Chief Executive Officer, Dr. Stanford Tang, President and Head of Research and Development, and Paul Rickey, Chief Financial Officer. Before I turn the call over to Mitch, I would like to remind you that we'll be making forward-looking statements during today's call. These forward-looking statements are based on our current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events potential publications of clinical data, and expectations regarding the sufficiency of cash and investments that differ materially from those anticipated in such forward-looking statements as a result of these risk and uncertainty. You may refer to the most recent SEC filings regarding the risk factors associated with these statements. Mitch, please go ahead.
spk10: Thank you, Tamrae. Alpine is off to a strong start in 2023, driven by progress in the development of COVID-19 access. a potentially best-in-class dual inhibitor of the BAF inhibitor cytokines with a convenient once every four weeks subcutaneous dosing regimen that we believe has the potential to benefit patients living with multiple types of autoimmune or inflammatory diseases. I'm pleased to announce that we recently achieved a significant milestone with the initiation of the Ruby 3 BASC study, our first patient-based study for the program. which will study poietatic tests in autoimmune glomerulonephritis indications, including IgA nephropathy, lupus nephritis, and primary membranous nephropathy. Although still early in development, investigator enthusiasm for the program and interest in participating in the RUBI3 study is highly encouraged. In addition to RUBI3, we are planning to initiate the RUBI4-BEST study in autoimmune cytopenias in the second quarter of 2023. This includes autoimmune thrombocytopenia, warm autoimmune hemolytic anemia, and cold aglutinous disease. We expect to share initial data from both the RUBI3 and RUBI4 basket studies by the end of this year. We see broad development potential for Povatex except in multiple indications beyond the basket studies, including our RUBI2 study in systemic lupus erythematosus, as well as neurologic, dermatologic, and other rheumatic disease indications. We recently signed a collaboration with Truvada to help accelerate the broad development of COVID tax steps across these multiple indications. With an increasingly competitive and sometimes challenging clinical trial environment, Truvada gives us access to its 28 partner members who provide 16% of patient care in the United States. In addition to our own efforts, we will leverage Truveta's platform and analytics capabilities to more quickly identify and recruit study participants for Ruby 3 and Ruby 4 with the potential to benefit most from Povitaciseps. We believe Povitaciseps has the potential to be a pipeline and a product. With our strong balance sheet and promising preclinical and phase 1 healthy volunteer data, we are rapidly moving forward with a robust development plan for Povitaciseps. And now I'll hand the call over to Stanford to review our progress, provide updates, and a broad general plan for BOVI in more detail. Stanford?
spk09: Thank you, Mitch. As a reminder, Cova-Tachycept is an FC fusion of a variant tachy domain engineered to inhibit more potently the April and Bass cytokine than wild-type tachy Ig fusion proteins. The clinical relevance of these cytokines continues to grow in multiple autoimmune diseases. With proof of concept and or encouraging clinical data with various agents in this class, in diseases such as systemic lupus, lupus nephritis, IgA nephropathy, Sjogren's syndrome, and myasthenia gratis. In preclinical studies, Cova-Tachycept appears superior to wild-type Tachy-IgE comparators, as well as inhibitors of only April or Bath. It demonstrates potent activity in multiple disease-relevant animal laws. In phase one, first in human study and adult healthy volunteers, Cova-Tachycept has been well tolerated. It has demonstrated excellent PK and PD, including dose-related reductions in circulating antibody-secreting cells and serums in globulins, as well as the IgA nephropathy-relevant biomarker, galactose-deficient IgA1. To gain initial multi-dose experience in disease populations, we are initially focusing on two basket studies. The first is RUBI3, an open-label basket study in autoimmune glomerulonephritis. This study has just recently begun enrollment. Second to shortly follow is RUBI4, an open-label basket study, and autoimmune cytopenias. With the initial data from these studies, we anticipate the ability next year to begin multiple Phase II studies, including one into systemic lupus erythematosus, known as Ruby 2. Additional studies in other disease areas are of great interest, including nephrology or hematology, neurology, dermatology, as well as rheumatology besides lupus. Some of these we envision could proceed via an accelerated approval pathway. In summary, Pogatex has potently targeted both the E. coli and BAF cytokines in a unique, highly differentiated way. It has just become patient-based studies and has broad development potential.
spk08: We look forward to sharing additional data as the program progresses. I'll now turn the call over to Paul. Thank you, Stanford.
spk11: I will now provide an overview of our financials for the fourth quarter ended September 31, 2022. Revenue recognized under our collaboration program. for the quarter ended December 31st, 2022 was 2.8 million compared to 4.5 million in 2021. The decrease primarily relates to lower revenue recognized under our collaboration with Abbey, partially offset by revenue recognized for services performed in connection with our collaboration with Verizon, which was executed in late 2021. Research and development expenses for the fourth quarter ended December 31st, 2022 were $18.8 million compared to $15.4 million in 2021. The increase was primarily attributable to higher personnel-related expenses due to the increased headcount to support our ongoing and planned clinical development programs. General and administrative expenses for the fourth quarter ended December 31, 2022, were $4.4 million compared to $4.5 million for 2021. Company recorded net losses of $18.9 million and $15.2 million for the fourth quarter ended 2022 and 2021, respectively. As of December 31st, 2022, Alpine's cash and investments totaled $273.4 million, which we anticipate should be sufficient to fund our planned operations through 2025.
spk08: I'll now hand the call back to Mitch. Thanks, Bob.
spk10: As Stanford highlighted, we are highly encouraged by the progress of Pobitacacept, a molecule that we believe is the only truly potent dual April bath inhibitor. As a result, we believe in the broad potential for the program may become an important new disease modifying therapy across multiple B-cell mediated autoimmune and inflammatory diseases. Closing, we believe we have laid a strong foundation for launching the next phase of Alpine as we progress throughout the course of this year and into next year. Operator will now open the phones for questions.
spk03: Thank you. If you would like to ask a question, please signal by pressing star one on your telephone keypad. If you are using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Again, press star one to ask a question. And we'll take our first question from the line of Mike Oltz from Morgan Stanley. Please go ahead.
spk07: Hey guys, thanks for taking the question and congrats on getting the Ruby 3 study going here. Maybe just a question in terms of both basket studies and maybe you can comment on how you're currently thinking about dosing and if there's any additional dosing work you plan to do before getting into the indication-specific cohorts in the basket studies. And I guess part of why I'm asking, I looked on clinicaltrials.gov, and I noticed some differences in the dosing that you're using for Ruby 3 and Ruby 4. Thanks.
spk10: Yeah. Maybe I'll take the first part of that, Mike. Thanks for the question. Then I'll ask Stanford. I don't know if you want to. So just as a reminder, Ruby 3 has two different dose escalations that we'll be going through, both an 80-milligram cohort and a 240-milligram cohort. And Ruby 4 will be going directly into a 240-milligram dosing group. So, there'll be no 80-milligram cohort in that group.
spk09: That's correct. And so, there's no pre-indication sort of phase of the study. We'll be going directly into all three diseases in both trials at the doses that Mitch mentioned.
spk07: Got it. That's helpful. Maybe just one more question from me. I noticed in the press release for Ruby 2, you plan to sort of start that study at mid-2024, and you make a comment based on some enabling data from Ruby 3 and Ruby 4 studies. Maybe you can just clarify what you're hoping to learn from those studies that will enable you to start Ruby 2.
spk09: It's primarily multi-dose data, since, as you know, the Phase 1 study we ran is a single ascending dose study. In addition, it will give us greater confidence in the dose selection for the Phase 2, since that's a large study. Yep.
spk07: Got it. Thanks so much.
spk08: Thanks, Mike.
spk03: And we'll take our next question from the line of Tara Bancroft with Cowan. Please go ahead.
spk04: Hi, guys, and thanks for taking the question. So I'm wondering what do you expect the rate of enrollment to be in the basket studies now, especially given the Truveta collaboration? And when do you think that you might reach full enrollment? Thanks.
spk10: Well, what I'll say is that enrollment in general has been a challenging clinical trial environment to enroll patients. That being said, I'm pretty pleased with the way Ruby 3 has started. We're getting a lot of investigator interest and a lot of patient interest. And I think you saw that. and our comments in the press release today. So that, in and of itself, is encouraging, but I would say it's early on in the start of that trial, but if that trend continues, we expect it to enroll fairly rapidly.
spk08: The Truveta collaboration, I'll talk a little bit about, sir.
spk10: I appreciate you bringing that up. You know, I think, you know, we've always enrolled in trials in a very kind of traditional way. We work with CROs, and we engage investigators in a really kind of active way to identify patients and bring them into trials. I think one of the things as an industry that we've done fairly poorly is using some of the new electronic medical record systems and large cohorts of patients across multiple centers to identify them quickly and then recruit patients in clinical trials. Obviously, Truvette is a Seattle-based company. We know them well and work with them to kind of enable their, you know, member partners to identify patients that are relevant, who would be three and who would be four, to enroll them in our clinical trials.
spk02: Okay, thanks.
spk03: And we'll take our next question from the line of Thomas Smith with SDB Securities. Please go ahead.
spk06: Good afternoon. This is Brian Connolly on for Tom. I believe you just responded to a question about Truveta, but just curious if there are any other gating factors or any other obstacles or challenging factors you're encountering as you're progressing the basket trials. Thanks.
spk10: Yeah, thanks, Brian. No, I mean, the reason we put Truveta in place was to be proactive at the start of the study. You know, these are things that you want to be in front of. I would say our traditional efforts are looking as good as I've seen the trial get started in terms of launch. I think it's because of awareness on the targets and strong awareness in the space, and we have a great group of investigators that we brought in. The reason we brought Truveta on board is we didn't want to have to, you know, add it on later on. We wanted to, number one, do it at the beginning of the trial, and two, as we push We wanted the collaboration between us and Tribeta to be kind of fully integrated so we can leverage it as we move into bigger studies.
spk08: Great. Thanks so much.
spk03: And we'll take our next question from the line of Mark Breidenbach with Oppenheimer. Please go ahead.
spk12: Hey, good afternoon, guys. Thanks for taking our questions. Just a quick couple from me. First, on the Truveta collaboration, have you specified what they're getting in return for helping optimize enrollment of Ruby 3 and Ruby 4?
spk08: I'm sorry, Mark.
spk12: I lost you there one second there. Can you say that one more time? Yeah, sorry. What's Truveta getting in return for helping you guys enroll in Ruby 3 and Ruby 4?
spk10: It's a traditional services agreement, so there's kind of a baseline fee that we pay that, you know, and then as they enroll a certain number of patients, they have certain objectives that they need to meet to be able to generate service fees as a result of that. So, it's not any different than a traditional services agreement.
spk12: Okay, got it. And with regard to the upcoming presentation at WCN from Ruby 1, Is there anything in that presentation that we haven't already seen? What's kind of going to be the focus of that upcoming presentation next week?
spk09: Our main goal is to reiterate awareness. We didn't present there last year, and I'm sure you're aware. But make sure that, you know, just build awareness about the target and the molecule with that audience. There will be updated phase one data with regard to additional follow-up to some of the subjects. although the general conclusions have not changed, which you can tell from some of our preceding comments.
spk12: Okay, got it. And maybe one last one from me. I know you mentioned the 80-milligram and 240-milligram dosing cohorts in Ruby 3. Can you just comment on the dosing schedules and how those compare to, let's say, you know, if we use teletasticept as the closest equivalent or competing drug, how the dosing schedules compare between your drug and Remagen's. Thank you.
spk09: Yeah, our trials both are dosing at a Q4-week dose regimen, and that's at all doses or both doses being tested. As far as we are aware, Remagen is 160 milligrams sub-Q weekly, and that appears to be their doses for all their physical trials. So, in comparison, we're Q4 versus Q1 week.
spk10: And, you know, Mark, that's one of the key, when we start to talk about best-in-class potential for POVI, one of the key things that differentiate us is, one, that when we're opposing Q2, that we have a much more convenient dosing schedule, and the fact that we cover both cytokines more completely than either of the wild-type taffies out there allows us to take a pretty broad development plan going forward.
spk08: Got it. Thanks for taking our questions. Thank you.
spk03: And we'll take our last question from the line of Joe Pankinis with HC Wainwright. Please go ahead.
spk05: Hey, everybody. Good afternoon. Thanks for taking the question. Wanted to get a little more color, if you can, regarding the end-of-year initial data from both Ruby 3 and Ruby 4. Is this going to be essentially early response type of data for each type of indication, or can we get more than that initially with regard to, say, any translational or PD data?
spk09: Yeah, we'll be focusing quite a bit on both traditional endpoints as well as biomarker-related data. So PD endpoints, including immunoglobulin target, cytokine targets, as well as what I mean by biomarkers are things like IgG, IgG1, and IgG nephropathy. And each of those indications has their respective antibody that we'll be looking at. So we'll be looking at all of that and look forward to being able to report that towards the end of the year.
spk05: That's great. And do you think you could just remind, I mean, since it's a basket concept, you know, how many per indication you're looking for and how many you think that might deliver for the initial data? It's a basket trial.
spk10: We'll see how many patients we collect. And I can tell you that we're getting interest, at least in Ruby 3 so far, we're getting interest across all the different subtypes, that being IGAN, lupus nephritis, and primary membranous nephropathy. Exactly how that mix is going to shake out, I think it's too early to say right now. But early on, we're pretty pleased with the mix of interest that's coming into the trial.
spk08: Sure. Got it. Thanks a lot. Okay.
spk02: There are no further questions, Dr. Gold. I'll turn the call back over to you.
spk10: Thank you, operator. I'd like to thank you all for taking part in today's call. We look forward to seeing many of you at upcoming investor and medical meetings and providing updates in the months ahead.
spk08: Thank you, and have a great afternoon.
spk02: Thank you, ladies and gentlemen. This concludes our call today. You may now
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