Q4 2022 Alpine Immune Sciences Inc Earnings Call

Speaker 1: 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.

Speaker 1: and corporate communications at Alpine. Ms. Johnson, I'll now turn the call over to you.

Speaker 2: Thank you, Carrie. 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 Pang, President and Head of Research and Development, and Paul Ritchie, Chief Financial Officer.

Speaker 2: 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 in the data are all available on our website.

Speaker 2: to differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties.

Speaker 2: You may refer to the most recent SEC filings regarding risk factors associated with these cases.

Speaker 3: Mitch, please go ahead.

Speaker 4: Thank you, Tamara.

Speaker 5: Outline is off to a strong start in 2023, driven by progress in the development of clovewind chatty step.

Speaker 5: potentially best-in-class dual inhibitor of the VAP and H2S.

Speaker 5: with a convenient, once every four week, resellable self-fu Mikretti S hosting regimen

Speaker 5: that we believe has the potential to benefit patients living with multiple types of autoimmune inflammatory diseases.

Speaker 5: I'm pleased to announce that we recently achieved a significant milestone for vitaxicin with the initiation of the Ruby 3 basket study.

Speaker 5: Our first patient-based study for the program, which will study clove attack success and autoimmune glomerulonephritis indications, including IJ nephropathy, lupus nephritis, and primary membranous nephropathy.

Speaker 5: Although still early in development, investigator enthusiasm for the program and interest in participating in the Ruby 3 study is highly encouraged.

Speaker 5: In addition to Ruby 3, we are planning to initiate the Ruby4Bats study of autoimmune metapenias in the second quarter of 2023.

Speaker 5: This includes autoimmune thrombocytopenia, warm autoimmune hemolycademia.

Speaker 5: and call the glue disease.

Speaker 5: We expect to share initial data from both the Ruby 3 and Ruby 4 basket studies by the end of this year.

Speaker 5: We see broad development potential for probitaxis steps in multiple indications beyond the vascular studies.

Speaker 5: including our Ruby II study in systemic lupus erythematosus, as well as neurologic, dermatologic, and other rheumatic disease indications.

Speaker 5: We recently signed a collaboration with TruVeta to help accelerate the broad development of attack sets across these multiple indications.

Speaker 5: With an increasingly competitive and sometimes challenging clinical trial environment, Triveda gives us access to its 28 partner members who provide 16% of patient care in the United States.

Speaker 5: In addition to our own efforts, we will leverage Trevita'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 COVID-19.

Speaker 5: We believe public access has the potential to be a pipeline and a project.

Speaker 5: 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 public access.

Speaker 5: And now we have a follow-up with Stanford to review our progress, provide updates, and our broad development plan to both be in more detail. Stanford? Thank youlag afkol

Speaker 4: Thank you, Mitch.

Speaker 6: As a reminder, COVID-Tachyceps is an Fc fusion of a variant Tachy domain engineered to inhibit more cozenbeat in April and Vast cytokine than wild-type Tachy-Ig fusion protein.

Speaker 6: The clinical relevance of these cytokines continues to grow in multiple autoimmune diseases.

Speaker 6: with proof of concept and or encouraging clinical data with various agents in this class in diseases such as systemic lupus, lupus nephritis, IVA nephropathy, Sjogren's syndrome, and might nephritis.

Speaker 6: In preclinical studies, COVID-19 tests appear superior to wild-type Tacky IG comparators, as well as inhibitors of only April or VAP, to demonstrate potent activity in multiple disease-relevant animal models.

Speaker 6: Phase one, first is human study and adult healthy volunteers. Open text is definitely well tolerated.

Speaker 6: It has demonstrated excellent PK and PD, including dose-related reductions in circulating antibody secreting cells and serum in globulins, as well as the IgA-to-propsomy-relevant biomarker, the lactose-deficient IgA1. To gain initial multi-dose experience in disease populations, we are initially focusing on two Baptist studies.

Speaker 6: The first is Ruby 3, an openly well-basted study at autoimmune glomerulonephritis. This study has just recently begun enrollment.

Speaker 6: Second to shortly follow is Ruby 4, an open-label basket study in autoimmune-sized teams.

Speaker 6: With the initial data from these studies, we anticipate the ability next year to begin multiple phase II studies, including one into semisublucous erythematosus known as Ruby II.

Speaker 6: Additional studies in other disease areas are of great interest, including nephrology or hematology, neurology, dermatology, as well as rheumatology besides movement.

Speaker 6: Some of these being efficient could proceed via an accelerated approval pathway.

Speaker 6: In summary, Plovatex supposedly targets both the effluent-bastatic kinds in a unique, highly differentiated way. It has just become patient-based studies.

Speaker 6: and has broad development potential.

Speaker 6: We look forward to sharing additional data as the program progresses.

Speaker 6: sharing additional data as the program progresses. I'll turn the call over to Paul.

Speaker 6: Thank you, Stanford. I will now provide an overview of our financials for where the quarter ended, November 31, 2022.

Speaker 6: Revenue recognized under our collaboration programs for the quarter ended December 31st, 2022 was $2.8 million compared to $4.5 million in 2021.

Speaker 6: partially offset by revenue recognized for services performed in connection with our collaboration with Verizon, which was executed in late 2021.

Speaker 6: Research and development expenses for the fourth quarter ended December 31, 2022, for $18.8 million compared to $15.4 million in 2021. The increase was primarily attributable to higher personnel-related expenses and increased headcount to support our ongoing and planned clinical development programs.

Speaker 6: General and administrative expenses for the fourth quarter and in December 31st, 2022 for $4.4 million compared to $4.5 million for 2021.

Speaker 6: Some may be reported that losses of 18.9 million and 15.2 million for the fourth quarter ended in 2022 and 2021 respectively. As of December 31, 2022, I'll find cash and investments total 273.4 million.

Speaker 6: which we anticipate should be sufficient to fund our planned operations through 2025.

Speaker 6: I'll now hand the call back to Mitch.

Speaker 4: Thanks, Bob.

Speaker 5: Stanford highlighted, we are highly encouraged by the progress of COVID-19.

Speaker 5: A molecule that we believe is the only truly potent dual April-Bath inhibitor.

Speaker 5: As a result, we believe in the broad potential for the program may become an important new disease-modifying therapy.

Speaker 5: across multiple B-cell mediated, auto-mute, and inflammatory diseases.

Speaker 5: Closing, we believe we have laid a strong foundation to launch into the next phase of the pipeline as we progress throughout the course of this year and into next year.

Speaker 4: Halfway through now, open the phone for questions.

Speaker 1: Thank you. If you would like to ask a question, please signal by pressing star 1 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 1 to ask a question.

Speaker 1: And we'll take our first question from the line of Mike Ults from Morgan Stanley .

Speaker 1: from the line of Mike Oltz from Morgan Stanley . Please go ahead.

Speaker 7: 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...

Speaker 7: indication specific cohorts in the basket studies and I guess part of why I'm asking I looked on clinical trials.gov and I noticed

Speaker 7: some differences in the dozing that you're using for Ruby 3 and Ruby 4. Thanks.

Speaker 5: Yeah, maybe I'll take the first part of that, Mike, thanks for the question, then I'll ask Stanford and Adam if he wants 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.

Speaker 4: That's correct. And so there's no pre-

Speaker 6: Indication sort of phase of the study will be going directly into all three diseases in both trials at the doses that Mitch mentioned.

Speaker 7: Got it. That's helpful.

Speaker 7: 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 on some based on some enabling data from from Ruby 3 and Ruby 4 studies maybe you can just

Speaker 7: clarify what you're hoping to learn from those studies that will enable you to start Ruby 2? It's primarily multi-dose data. 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.

Speaker 4: Yep, got it. Thanks so much.

Speaker 8: Thanks so much. Bye.

Speaker 1: And we'll take our next question from the line of Tara Bancroft with Callan. Please go ahead.

Speaker 9: Hi guys and thanks for taking the question.

Speaker 9: So I'm wondering what do you expect the rate of enrollment to be in the basket? So he's now, especially given the Tuveta collaboration and when do you think that you might reach full enrollment? Thanks.

Speaker 5: Well, you know, what I'll say is that, you know, enrollment in general has been a challenging kind of a trial environment in rotation.

Speaker 5: 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. I think you saw that in 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. If that trend continues, we expect it to enroll fairly rapidly. The Triveda collaboration on top of a little bit...

Speaker 5: kind of medical records system, then large cohort to patients across multiple centers to identify them quickly, and then recruit patients in the clinical trials. Obviously, Triveda 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 for Ruby 3 and Ruby 4 to enroll them in our clinical trials. So, thank you very much for participating today.

Speaker 10: Okay, thanks.

Speaker 1: And we'll take our next question from the line of Thomas Smith with SBB Securities. Please go ahead. and ? soiatide. Sk? empowered others.org. d

Speaker 11: Good afternoon. This is Brian Conley on for Tom. Um.

Speaker 11: I believe you just responded to a question about Traveta, but just curious if there are any other getting factors or any of their obstacles or challenging factors during countering as you're progressing the BASCA trials.

Speaker 5: Yeah, thanks Brian . No, I mean the reason we put your vet in place was to be proactive at the start of the study. 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 because awareness on the targets and strong awareness in the space and we have a great group of investigators that was brought in.

Speaker 5: The reason we brought Trevetta on board is we didn't want to have to add it on later on. We wanted to, number one, do it at the beginning of the trial. And two, as we push into phase two studies next year, that could result in accelerated approval. We wanted the collaboration between us and Trevetta to be fully integrated so we can leverage it as we move into bigger studies.

Speaker 4: Thanks so much.

Speaker 11: Great, thanks so much.

Speaker 11: And we'll take our next question from the line of Mark Breidenbach with Oppenheimer. Please go ahead. Hey, good afternoon you guys. Thanks for taking our questions. Just a quick couple for me. First on the Truvetta collaboration, have you specified what they're getting in return for helping optimize enrollment of a group?

Speaker 5: and we pay that. And then the ASA and Rural of certain number of patients, they have certain objectives that they need to meet to be able to generate service fees and the results of that. So it's not any different than a traditional service. Okay, got it. And with regard to the upcoming presentation at WCN from Ruby.

Speaker 7: build awareness about the target and the molecule with that audience. There will be updated phase one data, which, regard to additional follow-up of some of the subjects. All of the general conclusions have not changed, but you can tell from so far, preview comments.

Speaker 11: Okay, got it and maybe one last one for 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 if we use telecast to set that the closest.

Speaker 11: equivalent or competing drug, how the dosing schedules compare between your drug and hemroglyce, always have a link to you, but the most challenging at hand to? the

Speaker 7: Yeah, our trials both are dosing at a Q4 week dose regimen and that's at all doses for 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 pivotal trials.

Speaker 5: So in comparison, we're Q4 versus Q1 week. And you know, Mark, that's one of the key, when we start to talk about best in class potential for POBY, one of the key things that differentiate us is one, that when we're posing two, that we have a much more convenient chosen schedule. And the fact that we cover both cytokines more completely.

Speaker 5: that either of the wild-type taffies out there allows us to take a pretty broad development plan going forward.

Speaker 4: Got it. Thanks for taking their questions.

Speaker 4: Thanks for taking their questions.

Speaker 1: And we'll take our last question from the line of Joe Panginis with H.C. Wainwright. Please go ahead. This question, speaking ofolor, choose your since it is discussed in the percent agree

Speaker 12: 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...

Speaker 7: what I mean by biharpers are things like a GTIG-1 in ID to prop the, and each of those indications has their respective antibody that we'll be looking at. So we'll be looking all that and look forward to P100 for that 20-year.

Speaker 7: are things like a GDIG-1 and an ID to prop up the, and each of those indications has their respective, probably, on a body that we'll be looking at. So we'll be looking all that and look forward to being able to report that 20th year. And do you think you could just remind?

Speaker 12: 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.

Speaker 5: This is the baddest in trial. Joseph, we're in a low. We'll see how many patients we can why can't tell you that we're getting interest. Least in Ruby 3 so far, we're getting interest to press all the different subtexts, stepping, high-gan, loosen and brightest in primary memories and property. 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 is coming into the trial.

Speaker 12: Sure, got it. Thanks a lot.

Speaker 13: Thanks a lot. Okay.

Speaker 5: There are no further questions, Dr. Gold. I'll turn the call back over to you. 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. Thank you and have a great afternoon.

Speaker 1: Thank you ladies and gentlemen, this concludes our call today.

Speaker 1: You may now disconnect.