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spk08: Welcome to the Alpine Immune Sciences third quarter earnings call. Currently, all participants are in a listen-only mode. As a reminder, this event is being recorded. I would now like to introduce Tamarie Johnson, Senior Director of Investor Relations and Corporate Communications at Alpine. Ms. Johnson, I will now turn the call over to you.
spk00: Thank you, operator.
spk07: Good afternoon, and thank you for joining us. With me on today's call are Dr. Mitchell Gold, Executive Chairman and Chief Executive Officer, Dr. Stanford Pang, President and Head of R&D, Dr. Andrew Sandler, Chief Medical Officer, Paul Rickey, Chief Financial Officer, and Dr. Remy Durand, Chief Business Officer. Before I turn the call over to Mitch, I would like to remind you that we'll be making forward-looking statements during the course of today's call. I encourage you to refer to the most recent SEC filings regarding the risk factors associated with these statements. Mitch, please go ahead.
spk03: Thank you, Tamara. This quarter marked several important milestones for Alpine, starting with our inaugural R&D day in September, followed by presentations and multiple scientific meetings over the last several months, where we shared promising data that supports the best-in-class potential for our lead program, Alpine 303. We are now operationalizing a near-term broad development plan for Alpine 303 in multiple indications, with the most proximal studies to begin in a renal basket, as well as a hematology basket, with anticipated data from these studies by the end of next year. Importantly, based on data from the RUBI-1 study, we plan to move forward with a convenient dosing schedule once every four weeks and a best-in-class profile of inhibiting both APRIL and BAP simultaneously. To further accelerate development of alpine 3-to-3 across multiple indications, We recently completed a successful and oversubscribed $113 million following offering, bringing in additional top-tier investors and extending our cash run rate through the end of 2025. This additional capital will fund key catalysts for Healthline 303 with initial data by the end of next year, potentially enabling the initiation of pivotal or accelerated approval studies in certain indications. Following the termination of enrollment in the Alpine 202 clinical studies last month, Alpine is now focused squarely on driving value from its immunology and inflammation activities, including our collaborations with AbbVie and Horizon. I now hand the call over to Stanford to talk about Alpine 303 in more detail. Stanford? Thank you, Mitch.
spk05: As a reminder, Alpine 303 is an SD fusion of an engineered taxidermy. and a potent dual inhibitor of the BASP and APRIL B-cell cytokines in development for lupus and other autoantibody-related diseases. This rationale is strongly supported by prior clinical experience with multiple drugs in this pathway, including the anti-BASP antibody bilimumab or Benlispa, the anti-APRIL antibody, and two wild-type tachy-FC fusions, the tachycept and teletachycept, which are structurally related to alpine CO3 and target BASP and APRIL. These drugs collectively have been approved for and or show significant promise for the treatment of systemic lupus or lupus nephritis, and or show encouraging initial data in IgA nephropathy, among other indications. Lupus and autoimmune glomerulonephritis conditions are therefore of particular interest for Alpine 303, but based on its mechanism of action, it may prove effective for many other autoantibody-related diseases as well. Over the past few months, we've reported that a key advantage of Alpine 303 is its engineering, which results in a highly potent inhibitor of both BAF and APRIL, distinguishing it from the wild-type tachys, which do not appear to inhibit APRIL as well. These, therefore, suggest that alpine CO3 may be the first truly dual potent inhibitor of these two cytokines. Consistent with this, multiple preclinical studies demonstrated superior efficacy versus other inhibitors of BAF and or APRIL, including wild-type tachys. We have conducted and reported initial data from a first in human single ascending dose study of outline 303 adult healthy volunteers ruby one at a few different scientific conferences overall the drug has been very well tolerated as subcutaneous or intravenous doses up to 960 milligrams demonstrating dose dependent pharmacokinetics the pharmacodynamic effects have been quite encouraging including dose dependent reductions in free cytokine circulating immunoglobulins antibody secreting cells and the IgA nephropathy-related biomarker, lactose-deficient IgA1. Based on these findings, we anticipate therapeutic doses to be in the 80 to 240 milligram dose range administered subcutaneously every four weeks. If he's encouraging data, we're now in the process of initiating multiple clinical studies, including Ruby 2, a placebo-controlled, dose-ranging, randomized phase 2 study in systemic lupus. Briefly, this study will include adults with moderately to severely active lupus similar in design to this heart attack cell study. In addition, we're moving forward with Ruby 3, an open-label dose-ranging BASC study in autoimmune glomerulonephritis, including IgA nephropathy, lupus nephritis, and primary membranous nephropathy, as well as Ruby 4, an open-label BASC study in autoimmune cytopenia, including immune trauma cytopenia, warm autoimmune hemoepidemia, and cold aglutinin disease. Each of the indications in these BASC studies has strong scientific rationale for 303, based on the importance of specific autoantibodies and disease pathogenesis, as well as high medical needs. We anticipate proceeding into randomized studies in one or more of these indications based on initial data by the end of next year, preferably in the context of accelerated development pathways. I'll turn the call over to Paul.
spk04: Thank you, Stanford. I'll now provide an overview of our financials for the third quarter ended September 30, 2022. Alpine Cash Cash Equivalents and Investments totaled $277.1 million as of September 30, 2022. In September, we completed a $100 million underwritten public offering where we sold 13.6 million shares of our common stock with net proceeds of approximately $93.5 million after deducting underwriting commissions and estimated expenses. An additional 1.9 million shares of our common stock were sold pursuant to the underwriter's exercise of their over-allotment option, providing additional net proceeds of $13.1 million received upon closing on October 4, 2022, bringing our pro forma cash balance to $290.2 million as of September 30, 2022, which should be sufficient to fund current planned operations through 2025. Collaboration revenue for the third quarter was $8.4 million compared to approximately $8.5 million in the third quarter of last year. The 2022 amounts were primarily attributable to revenue recognized under the company's AbbVie and Horizon collaborations, while 2021 revenue recognized solely related to the AbbVie collaboration. Research and development expenses were $17.6 million in the third quarter of 2022 compared to $18.3 million in the third quarter of last year. The decrease primarily related to decreased clinical development activities on a year-over-year basis partially offset by increased personnel costs. General and administrative expenses for the third quarter of 2022 were $4.6 million compared to $3.5 million for the third quarter of last year, primarily due to increased personnel costs. Alpine recorded a net loss of $13.3 million in the third quarter of 2022, compared to 13.5 million in the third quarter of 2021. With that, I will now hand the call back to Mitch.
spk03: Thanks, Bill. As Stanford highlighted, the recent positive updates for alzheimer's 303 continue to reinforce what we believe to be the significant potential for the molecule to improve the lives of patients suffering from severe autoimmune and inflammatory diseases. We believe the alzheimer's 303 is potentially the only truly potent dual APOBAP inhibitor. And combined with its convenient once-every-four-week dosing, Alpine 303 is poised to launch into a broad development plan, which includes a Phase II lupus study, as well as basket studies in renal, hematologic, and other autoimmune diseases. We expect the first data from our basket studies to read out by the end of 2023, and as Stanford mentioned, potentially enabling the initiation of pivotal or accelerated approval studies in certain indications. In closing, our best-in-class profile for alpine 203 and our cash runway of three-plus years, we believe we have laid a strong foundation to launch the next phase of growth for alpine as we execute it on our ambitious tungsten mountain plants and a broad range of B-cell-mediated autoimmune and inflammatory diseases.
spk01: With that, I pray we'll now open the phones for questions.
spk08: Thank you, Dr. Gold. If you'd 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.
spk02: And we'll now pause as we wait for questions from the audience. And our first question will come from Mark Breidenbach with Oppenheimer.
spk06: Hi, this is Jacqueline from Oppenheimer. Our first question is, what is the expected cadence of data in the plant basket study? So, which indication in the basket study has the fastest time to efficacy data and why?
spk01: It was a little bit hard to understand you both.
spk03: The part that I heard at the end was which indication the basket studies would give you the fastest readouts for data? Was that the question?
spk06: Right. Yes.
spk01: Yes? Okay.
spk05: Well, we're not restricting enrollment across the three indications in each of the basket studies. So, right now, we expect the enrollment to reflect, perhaps, the frequency or the epidemiology of the indication. So, most likely, we'll see more IGAM subjects in the renal basket and more ITP subjects in the heme basket. we'll be operationalizing as fast as we can.
spk06: Okay. Our second question is, what kinds of new healthy volunteer data that will be included in the upcoming ASH presentation on the Ruby 1 that we haven't seen already?
spk05: I think there'll be some updates with regard to of the biomarkers, although what is particularly new in that poster will be some preclinical data supporting the target indication, the hematology target indication.
spk02: Okay. All right. Thanks. Thank you for taking our questions. Ready for the next question?
spk08: Thank you. And once again, if you would like to ask a question, please press star 1.
spk02: Again, we'll pause for just a moment. And there are no further questions, so that brings us to the end of our time for questions.
spk08: Dr. Gold, I'll turn the call back over to you.
spk01: Thank you, operator.
spk03: I'd like to thank everyone that took part in today's call, especially those in attendance, our investigators, and the volunteers and patients participating in our clinical trials. As you can tell, we're highly enthusiastic about the potential of Alpine's programs to meaningfully impact patients' lives. We look forward to providing updates in the months ahead.
spk01: Thank you very much.
spk08: And this concludes today's conference call. You may now disconnect.
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