Alpine Immune Sciences Inc (ALPN) 2022 Q3 法說會逐字稿

Please stand by. 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.

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'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.

Thank you, Temre. This quarter marked several important milestones at Alpine starting with our inaugural R&D Day in September, followed by presentations at multiple scientific meetings over the last several months, where we shared promising data that supports the best-in-class potential for our lead program, 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 a hematology basket with anticipated data from these studies by the end of next year. Importantly, 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 profile of inhibiting both APRIL and BAFF simultaneously.

To further accelerate development of ALPN-303 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 focused squarely on driving value from its 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?

Thank you, Mitch. As a reminder, ALPN-303 is an Fc fusion of an engineered TACI domain and a potent dual inhibitor of the BAFF and APRIL B cell cytokine in development for lupus and other auto autoantibody-related diseases. This rationale is strongly supported by prior clinical experience with multiple drugs in this pathway including the anti-BAFF antibody, belimumab or Benlysta, the anti-APRIL antibody, and two wild-type TACI-Fc fusions, atacicept and telitacicept, which are structurally related to ALPN-303 and target best in 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 other glomerulonephritis conditions are, therefore, a particular interest for ALPN-303. The baseline 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 ALPN-303 is its engineering, which results in a highly potent inhibitor of both BAFF and APRIL, distinguishing it from the wild-type TACIs, which do not appear to inhibit APRIL as well. These reports suggest that ALPN-303 may be the first truly dual potent inhibitor of these two cytokines. Assistant with this, multiple preclinical studies demonstrate a superior efficacy versus other inhibitors of BAFF and/or APRIL including wild-type TACI.

We have conducted and reported initial data from the first in-human single-ascending dose study of ALPN-303 in adult healthy volunteers, RUBY-1, at a few different scientific conferences. Overall, the drug has been very well tolerated at 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 immunoglobulin, antibody-secreting cells, and IgA nephropathy-related biomarker galactose-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.

With these encouraging data, we are now in the process of initiating multiple clinical studies including RUBY-2, a placebo-controlled dose-ranging randomized Phase 2 study for systemic lupus. Basically, this study will include adults with moderately to severely active lupus, similarly designed with its prototype (inaudible).

In addition, we're moving forward with RUBY-3, open-label dose-ranging basket study in autoimmune glomerulonephritis including IgA nephropathy, lupus nephritis, and primary membranous Nephropathy; as well as RUBY-4, open-label basket study in autoimmune cytopenias including immune thrombocytopenia, warm autoimmune hemolytic anemia, and cold agglutinin disease.

Each of the indications in these basket studies have strong scientific rationale for 303 based on the importance of specific autoantibodies in disease pathogenesis as well as high medical need. 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 an accelerated development pathway.

I'll now turn the call over to Paul.

Thank you, Sanford. I'll now provide an overview of our financials for the third quarter ended September 30, 2022. Alpine's 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 underwriters' 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 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 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.

Thanks, Paul. As Stanford highlighted, the 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 2 lupus study as well as basket studies in renal, hematologic, and other auto-immune diseases. We expect the first data from our basket studies to readout 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 execute on our ambitious drug development plans and our broad range of B cell-mediated autoimmune inflammatory diseases.

With that, operator, we'll now open the phone to the questions.

Thank you, Dr. Gold. (Operator Instructions) Mark Breidenbach, Oppenheimer.

Hi. This is Jacqueline for Mark from Oppenheimer. Our first question is what is the expected cadence of data in the current basket study? So which indication in the basket study has the faster time to efficacy data, and why?

Yeah. 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?

Right. Yeah.

Yes? Okay.

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 indications. So most likely we will see more IDN subjects in the renal basket and more ITP subjects in the hema basket. But we'll be operationalizing as fast as we can.

Okay. 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?

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 preclinical data supporting the target indications, the hematology target indications.

Okay. All right. Thanks. Thank you for taking our questions.

Ready for the next question.

(Operator Instructions) 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.

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 Alpine's programs to meaningfully impact patients' lives. We look forward to providing updates in the months ahead. Thank you very much.

And this concludes today's conference call. You may now disconnect.