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Intrinsic Value is all-important and is the only logical way to evaluate the relative attractiveness of investments and businesses.
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 Temre Johnson, Senior Director of Investor Relations and Corporate Communications at Alpine.
Ms. Johnson, I’ll now turn the call over to you.
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 Peng, 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 will be making forward-looking statements during today's call. These forward-looking statements are based on our current expectations and involve risk and uncertainties as a result and the timing of events, potential publication of clinical data and expectations regarding the sufficiency of cash and investment could differ materially from those anticipated in such forward-looking statements as a result of these risk and uncertainties. You may refer to the most recent SEC filings regarding risk factors associated with these statements.
Mitch, please go ahead.
Thank you, Temre. Alpine is off to a strong start in 2023 driven by progress in the development of povetacicept, a potentially best-in-class dual inhibitor of BAFF and APRIL cytokines with a convenient once every four weeks simultaneous dosing regimen that we believe has the potential manifestations with erythematosus, autoimmune inflammatory diseases.
I am pleased to announce that we recently achieved a significant milestone for Povetacicept with the initiation of the RUBY-3 basket study, a first patient-based study for the program, it will study Povetacicept 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 RUBY-3 study is highly encouraged. In addition to RUBY-3, we are planning to initiate the the RUBY-4 basket study an autoimmune autoimmune cytopenias in the second quarter of 2023.
This includes the autoimmune thrombocytopenia, warm autoimmune hemolytic anemia, and cold agglutinin disease. We expect to share initial data from both the RUBY-3 and RUBY-4 basket studies by the end of this year.
We see broad development potential for Povetacicept in multiple indications beyond the basket studies, including our RUBY-2 study systemic lupus erythematosus, as well as neurologic, dermatologic and other rheumatic disease indications.
We recently signed a collaboration with Truveta to help accelerate the broad development of Povetacicept across these multiple indications. But then increasingly competitive and sometimes challenging clinical trial Truveta gives us access to its 28th 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 Povetacicept. We will evoke Povetacicept has the potential to be a pipeline and project with a strong balance sheet and promising preclinical and Phase 1 healthy volunteer data, we are rapidly moving forward with a robust development plan for Povetacicept.
And now I will turn over the call over to Stanford to review our progress, provide updates on our broad plans for POVI in more detail. Stanford?
Thank you, Mitch. As a reminder, Povetacicept is an Fc fusion of a variant TACI domain, engineered to inhibit more potently the April and BAFF cytokines with wild-type TACI IV fusion proteins.
The clinical relevance of these cytokines continues to grow in multiple autoimmune diseases with proof-of-concept and/or encouraging clinical data is – in diseases such as systemic lupus, lupus nephritis, IgA, nephropathy, Sjogren's syndrome, and Myasthenia gravis.
In preclinical studies, Povetacicept has superior to wild-type wild-type TACI IV comparators, as well as inhibitors of only April and BAFF demonstrates potent activity in multiple disease relevant animal health. At Phase 1 human study in adult healthy volunteers, Povetacicept has been well tolerated. 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 nephropathy relevant biomarker, galactose-deficient IgA1.
Again initial multi dose experiences in each population we are initially focusing on two basket studies. The first is RUBY-3, an open-label basket study in autoimmune glomerulonephritides. This study has just recently begun enrolling.
Second, we shortly follow with RUBY-4, an open-label basket study in autoimmune cytopenias. The initial data from these studies we anticipate the ability next year to begin multiple Phase 2 studies including one in systemic lupus erythematosus known as RUBY-2. Additional studies in other disease areas are of great interest, including nephrology or hematology, urology, dermatology, as well as rheumatology besides lupus. Some of these we envision could proceed via an accelerated approval pathway.
In summary, Povetacicept can potently target both the April and BAFF cytokines in a unique highly differentiated way. [Indiscernible] study that has broad development potential. We look forward to sharing additional data as the program progresses.
I'll now turn the call over to Paul Rickey.
Thank you, Stanford. I will now provide an overview of our financials for the fourth quarter ended December 31, 2022. Revenue recognized under our collaboration programs for the quarter ended December 31, 2022 was $2.8 million, compared to $4.5 million in 2021. The decrease primarily related to lower revenue recognized under our collaboration with AbbVie, partially offset by revenue recognized in the services performed in connection with our collaboration with Horizon, which was executed late in 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 due to increased head count to support our ongoing and planned clinical development programs.
General and administrative expenses for the fourth quarter ended December, 31st 2022 we're $4.4 million, compared to $4.5 million for 2021. The company reported net losses of $18.9 million and $15.2 million for the fourth quarter ended 20 22 and 2021, respectively.
As of December 31st 2022, Alpine's cash and investments totaled $273.4 million, which we anticipate should be sufficient on our planned operation through 2025.
I will now hand the call back to Mitch.
Thanks, Paul. As Stanford highlighted, we are highly encouraged by the progress of Povetacicept, a milestone that we believe is the only truly potent dual /APRIL/BAFF inhibitor. As a result, we believe in the broad potential for the program may become an important immune disease-modifying therapy, present multiple be some mediated autoimmune and inflammatory diseases.
In closing, we believe we have laid a strong foundation to walk to the next phase of Alpine as we progress throughout the course of this year and into next year.
Operator, now open the phone for questions.
Thank you. [Operator Instructions]
And we'll take our first question from the line of Mike Ulz from Morgan Stanley. Please go ahead.
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.
Yes. Maybe I’ll the first part of that Mike. Thanks for the question and I’ll ask Stanford to walk you. So just as a reminder, RUBY-3 has two different dose escalations that will be going through both an 80 milligram cohort, and a 240 milligram cohort. And RUBY-4 will be going directly into the 240 milligram dosing group. So there will be no 80 milligram cohort in that group.
That's correct. And so, there's no, there's no pre-indication, sort of phase of the study will be going directly into all three diseases in both trials at the doses that Mitch mentioned.
Got it. That's helpful and maybe just one more question from me. I noticed in the press release. For RUBY-2 you plan to sort of start that study in mid 2024 and you make a comment on some - 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?
Primarily multi-dose data, as you know the phase one study we ran into those pending dose studies. In addition, it will give us greater confidence in to dose selection for the Phase 2 let’s say.
Good. Got it. Thanks so much.
Thanks, Mike.
And we'll take our next question from the line of Tara Bancroft with Cowen. Please go ahead.
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.
Well, we’ll update it. Enrolling in general has been a challenging in a clinical trial environment to enroll patients. That being said, I'm pretty pleased with the way RUBY-3 has started. We are getting a lot of investigator interest and a lot of patient interest and 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 purely on start of that trial but that trial continues we expect it to enroll fairly rapidly.
The Truveta collaboration, I'll talk a little bit about, Tara I appreciate you bringing that up. You know, I think we welcome to enroll the trials in a very traditional way we work with - and we engage investigators in a really active way to identify patients to bring up in the 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 work organization across multiple centers to identify them quickly and then include patients in the clinical trials.
Honestly, Truveta is a Seattle-based company. We know them well and work with them to kind of enable their member their member partners io identify patients that are relevant for RUBY-3 and we look forward to enroll them in our clinical trials.
Okay, thanks.
And we'll take our next question from the line of Thomas Smith with SVB Securities. Please go ahead.
Hi, good afternoon. This is Brian Conley 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.
Yeah. Thanks Brian. No, I think the reason we put Truveta 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 at let us exceed the trial and get started in terms of law I think because awareness on the targets and strong awareness in the space. And we have a great group of investigators that we have brought in.
The reason we brought Truveta onboard is we want to ask - add it on probably one of the number one, do it at the beginning of the trial. And two, as we push into the Phase 2 study next year that's clearly resulted in accelerated approval. We wanted the collaboration between us and Truveta to be kind of fully integrated, so we can leverage it as we move into these studies.
Great. Thanks so much.
Thanks.
And we'll take our next question from the line of Mark Breidenbach with Oppenheimer. Please go ahead.
Hey, good afternoon guys. Thanks for taking our questions. Just a quick couple from me. First on the Truveta collaboration. Have you any thoughts on what they're getting in return for helping optimize enrollment of RUBY-3 and RUBY-4?
I am sorry. I lost you one second. 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?
Let me take in traditional services agreement. So there's kind of a baseline fee that we pay them 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 and as a result of that. So, it's not any direct measures on services security.
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?
Our main goal is to - reader awareness we didn’t present there last year that I am sure you're aware, but make sure that, just build awareness about the target and the molecule with that audience, as it will be updated Phase 1 data with regard to additional follow-up is some of the subjects. Although the general conclusions about change that you can tell us some of our preceding comments.
Okay. Got it. Maybe one last one for me. I know, you mention the 80 mg and 240 mg dosing cohorts in RUBY-3. Can you just comment on the dosing schedules and how those compare to, let's say, if we use povetacicept as the closest equivalent or competing drug, how will the dosing schedules compare between your drug and RemeGen’s? Thank you.
Yeah, our trials both are doing things in a two four week dose regimen and as at all doses, for both doses being tested. As far as we are aware, RemeGen is 160 milligrams of Sub-Q weekly and it appears to be the doses for all their pivotal trials. So, when the person where Q4 versus Q1 week. As you know, we start to talk about best-in-class potential for POVI where the key things that differentiate us is, one that we were potent, two 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 TACI – in three broad development plan going forward.
Got it. Thanks for taking my questions.
Thank you.
And we'll take our last question from the line of with Joe Pantginis with H.C. Wainwright. Please go ahead.
Hey everybody. Good afternoon. Thanks 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?
Yeah, we'll be focusing quite a bit on both traditional endpoints, as well as biomarker-related data. So, PD endpoints, including immunoglobulintarget, cytokine targets, as well as biomarkers or things like a Gd-IgA1 in IG nephropathy as each of these indications has their respective antibody that we will be looking at. So we'll be looking all of that and look forward to be able to report that early this year.
That's great. And do you think you could just remind, I mean, since it's a basket concept, 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. We’ll see harmonization that I can say that we're getting interest. The recent RUBY-3 so far we are getting interest in across all the different subtypes, lupus nephritis and primary membranous nephropathy. Exactly how that mix is going to shake out surely to say right now, but early on we’re pretty pleased with the mix of interest that’s coming into the trial.
Sure, got it. Thanks a lot.
Thanks.
There are no for the questions, Dr. Gold. I'll turn the call back over to you.
Thank you operator. Thank you all for taking part in today’s call. We look forward to seeing many of you in upcoming investor and medical meetings and providing updates in the months ahead. Thank you and have a great afternoon.
Thank you ladies and gentlemen. This concludes our call today. You may now disconnect.