Alpine Immune Sciences, Inc. (NASDAQ:ALPN) Q3 2022 Earnings Call Transcript

Alpine Immune Sciences, Inc. (NASDAQ:ALPN) Q3 2022 Earnings Call Transcript November 14, 2022

Alpine Immune Sciences, Inc. misses on earnings expectations. Reported EPS is $-0.42 EPS, expectations were $-0.1.

Operator: 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 Temre Johnson, Senior Director of Investor Relations and Corporate Communications at Alpine. Ms. Johnson, I will now turn the call over to you.

Temre Johnson: Thank you, operator. 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 Peng, 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 will 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 the statements. Mitch, please go ahead.

Mitchell Gold: Thank you, Temre. This quarter mark several important milestones at Alpine, starting with our inaugural R&D Day in September, followed by presentations and multiple scientific meetings over the last several months, but we shard promising data that supports the best-in-class potential for our lead programs ALPN-303. We are now operationalizing, a near-term broad development plan for ALPN-303 in multiple indications with the most profitable studies to begin in a renal basket, as well as the hematology basket was anticipated data from the studies by the end of this year. And quarterly based on data from the RUBY-1 study, we plan to move forward with a convenient dosing schedule once every four weeks and best in class profiles of inhibiting both APRIL and BAFF simultaneously.

The further accelerate development is outlined three across multiple indications, we recently completed a successful and oversubscribed $113 million follow on offering, bringing additional top tier investors and extending our cash runway through the end of 2025. This additional capital will fund key catalysts for ALPN-303 with initial data by the end of next year, actually enabling the initiation of pivotal or accelerated approval studies in certain indications. Following the termination of enrollment in the ALPN-202 clinical studies last month, Alpine is now focus squarely on driving value from an immunology and inflammation activities, including our collaborations with AbbVie and Horizon. I’ll now hand the call over to Stanford to talk about ALPN-303 in more detail.

Stanford?

Stanford Peng: Thank you, Mitch. As a reminder, ALPN-303 is an Fc fusion of an engineer TACI domain and a potent dual inhibitor of the BAFF/APRIL B cell cytokine in development for lupus and other auto antibodies leading diseases. If rationale is strongly supported by prior clinical experience with multiple sclerosis pathways, including the antibodies golimumab , APRIL antibody and two wild type tacky Fc fusions except which are structured related to this ALPN-303 and target BAFF/APRIL. New 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 an autoimmune glomerulonephritides conditions are therefore particular interests are ALPN-303.

The baseline , it may prove effective for many other auto antibody related diseases as well. Over the past few months, we’ve reported that a key advantage of ALPN-303 is an engineering, which results in a highly potent inhibitor of both BAFF and APRIL, distinguishing it from the wild type tacky Ig which do not appear to inhibit APRIL as well. Either for suggest that ALPN-303 needs to be the first truly dual potent inhibitor of these two cytokines. The system within multiple preclinical studies demonstrating a superior efficacy versus other inhibitors of BAFF and/or APRIL excluding wild type TACI. We conducted and reported initial data from a first inhuman single attending dose study of ALPN-303 and adult healthy volunteers, RUBY-1 and a few different types of the costs.

Overall, the drugs have been very well tolerated as separate tedious for intravenous doses up to 960 milligrams, demonstrating dose dependent pharmacokinetics. The pharmacodynamic effects have been quite encouraging clean dose dependent reductions in pre cytokine, circulating immune globulin, antibody secreting cells and the IgA nephropathy related biomarker flexes, Gd-IgA1. Based on these findings, we anticipate therapeutic doses to be 80 to 240 milligram dose range, administered subcutaneously every four weeks. If the comparing data we’re now in the process of initiating multiple clinical studies, including RUBY-2 a placebo-controlled dose ranging randomized Phase 2 study systemic lupus. Briefly, this study will include adults with moderately to severely active similar designs and prototypes studies.

In addition, we’re moving forward with RUBY-3, an open label, dose ranging study and autoimmune arthritis equate including IgA nephropathy, lupus nephritis and primary membranous as well as RUBY-4, open-label basket study and autoimmune cytopenias including immune thrombocytopenia, worm autoimmune hemolytic anemia, and COVID glutenin disease. Each of the indications in the backet study have strong scientific rationale for 303, based on the importance of specific autoantibodies in disease pathogenesis, as well as high medical needs. Anticipate proceeding into randomized studies and one or more of these indications based on initial data by the end of next year, preferably in the context of accelerated development pathway. I’ll now turn the call over to Paul.

See also 20 Countries That Produce the Most Wheat and 10 Best Breakout Stocks To Buy.

Paul Rickey: 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 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. Additional 1.9 million shares of our common stock were sold pursuant to the underwriters exercise of their overlap and options, 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 is 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 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.

Mitchell Gold: Thanks, Paul. As Stanford highlighted, recent positive updates for ALPN-303 continue to reinforce what we believe to be the significant potential for the molecule to improve the lives of patients suffering from severe auto-immune and inflammatory diseases. We believe the ALPN-303 is potentially the only truly potent dual /APRIL/BAFF inhibitor. And combined with its convenient once every four week dosing, ALPN-303 is poised to launch a broad development plan, which includes the Phase II of study as well as basket studies in renal, hematologic and other auto-immune diseases. We expect the first data from our basket studies to lead up by the end of 2023 and as Stanford mentioned potentially enabling initiation of pivotal or accelerated approval studies in certain indications.

In closing, our best-in-class profile for ALPN-303 and our cash runway of three plus years, we believe we have made a strong foundation to launch to the next phase of growth for Alpine, as we executed on our ambitious drug development plans in a broad range of B cell mediated autoimmune and inflammatory diseases. With that, operator, we’ll now open this call for questions.

Q&A Session

Operator: Thank you, Dr. Gold. . And our first question will come from Mark Breidenbach with Oppenheimer.

Unidentified Analyst: Hi. This is Jacqueline for Mark from Oppenheimer. First question is, what is the expected adherence of data in the current basket study. So which indication in the basket study has the basket tying to efficacy data and why?

Mitchell Gold: Yes. It was a little bit hard to understand you, but 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?

Unidentified Analyst: Right. Yes.

Mitchell Gold: Yes. Okay.

Stanford Peng : 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 immunology of indications. So most likely we will see more IDAN subjects in the renal basket and more ITP subjects in the immune basket. But we’ll be operationalizing as fast as we can.

Unidentified Analyst: Okay. And our second question is what kind of new healthy volunteer data that will be included in the upcoming ASH presentation on the RUBY-1 that we haven’t seen already?

Mitchell Gold: I think there will be some updates with regard to some of the biomarkers, although what is particularly new in that poster will be some pre-clinical data supporting the target indication, the hematology target indications.

Operator: And there are no further questions, so that brings us to the end of our time for questions. Dr. Gold, I’ll turn the call back over to you.

Mitchell Gold: Thank you, operator. 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 our Alpine’s programs to meaningfully impact patient’s lives. We look forward to providing updates in the months ahead. Thank you very much.

Operator: And this concludes today’s conference call. You may now disconnect.