Alpine Immune Sciences, Inc. (NASDAQ:ALPN) Q4 2023 Earnings Call Transcript
Alpine Immune Sciences, Inc. (NASDAQ:ALPN) Q4 2023 Earnings Call Transcript March 18, 2024
Alpine Immune Sciences, Inc. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Ladies and gentlemen, welcome to the Alpine Immune Sciences Fourth Quarter 2023 and Full-Year Earnings Call. Currently, all participants are in a listen-only mode. As a reminder, this event is being recorded. And I would now like to introduce Temre Johnson, Senior Director of Investor Relations and Corporate Communications at Alpine. Ms. Johnson, please go ahead.
Temre Johnson: Thank you, Ravi. Good afternoon, and thank you to everyone for taking the time to join us today. With me on today's call from Alpine are Dr. Mitchell Gold, Executive Chairman and Chief Executive Officer; Dr. Stanford Peng, President and Head of R&D; Paul Rickey, Chief Financial Officer; and Dr. Remy Durand, Chief Business Officer. Before I turn the call over to Mitch, I'd like to remind you that we'll be making forward-looking statements during today's call. These forward-looking statements represent our views as of today and are based on our current expectations and consequently involve risks and uncertainties. Actual results could differ materially from those anticipated in such forward-looking statements as a result of such risks and uncertainties. I encourage you to refer to the most recent SEC filings regarding the risk factors associated with these statements. Mitch, please go ahead.
Mitchell Gold: Thank you, Temre, and thank you all of those who are participating in the webcast today. 2023 was a transformational year for Alpine with initial IgA nephropathy data presented at the American Society of Nephrology's Kidney Week suggesting a best-in-class profile of povetacicept, our wholly-owned next-generation dual BAFF/APRIL inhibitor with once-monthly dosing developed using our direct evolution platform. We are still only in the early stages of exploring the full potential of povetacicept. On the back of strong enthusiasm around ASN, we closed an oversubscribed $150 million equity offering to accelerate multiple development activities. With our encouraging data set in IgAN, convenient once-monthly dosing regimen, a strong balance sheet, we are rapidly advancing development of POVI as a potentially meaningfully new therapeutic option for patients living with IgAN, lupus, and multiple other autoimmune and inflammatory diseases.
Looking ahead, we are well positioned for meaningful catalysts in 2024 and beyond. In April, we plan to present additional data on povetacicept in IgA nephropathy, including the follow-up data from the 80-milligram monthly and initial data from the IgAN 240-milligram monthly dose cohorts at the Royal Congress of Nephrology meeting next month. Following this data, in the second half of the year, we plan to initiate RAINIER, a pivotal Phase 3 study of povetacicept in IgA nephropathy; and DENALI, a Phase 2 study of povetacicept in SLE. In addition to updates on our clinical studies, we look forward to sharing translational data that further supports the best-in-class potential of povetacicept in multiple diseases. I'll now hand the call over to Stanford to review our progress and provide updates on our development plan for povetacicept in more detail.
Stanford?
Stanford Peng: Thank you, Mitch. As Mitch has described, the emerging clinical findings with povetacicept continue to inspire us to advance as rapidly as possible. At last year's Kidney Week meeting, we reported the first clinical observations with povetacicept in IgAN, where it was associated with a greater than 50% reduction from baseline in proteinuria at six months as measured by urine protein-creatinine ratio or UPCR. In addition, the majority of patients met remission criteria as defined as a reduction in UPCR of less than 0.5 grams per gram, at least a 50% reduction in UPCR from baseline and stable renal function as assessed by estimated glomerular filtration rate or eGFR. Importantly, these findings were associated with significant reductions in a key IgAN biomarker, Gd-IgA1, supporting the concept of povetacicept as a disease-modifying therapy.
As a reminder, the improvable efficacy target has historically been a 30% reduction in proteinuria at nine months. Our very encouraging findings continue to hold up with additional agents and with longer follow-up, povetacicept could indeed be a particularly compelling therapeutic option for patients with IgAN and other autoimmune diseases. Therefore, since ASN, we've been making every effort to prepare the program and the company for the next pivotal stage of development. We look forward to the opportunity to provide a formal clinical data update on povetacicept in IgAN next month at the World Congress of Nephrology, which will take place in a late release poster. In the meantime, our primary development goal for povetacicept is its advancement this year to a pivotal trial IgAN, which we're calling RAINIER.
Of course, several other autoimmune and/or inflammatory disease indications remain of great potential interest for povetacicept. First, lupus remains a key indication, second only to IgAN, supported by the clinical validation of the pathway efficacy by BAFF inhibition and wild-type TACI IV molecules. We continue to plan to initiate a Phase 2 study in lupus called DENALI later this year. Second, we continue to explore other renal indications in the RUBY-3 study. At last year's Kidney Week, we described a single patient with primary membranous nephropathy, or pMN, would achieve an immunological remission of povetacicept. Such a finding suggests that other autoantibody-related diseases may benefit from povetacicept. Indeed, we continue to enroll additional subjects with pMN.
And as a reminder, RUBY-3 is also enrolling lupus nephritis and has just recently opened an ANCA-associated vasculitis cohort. In addition, we continue to explore autoimmune cytopenia in the RUBY-4 study. We look forward to future opportunities to share these collective data. Finally, ongoing and emerging preclinical and translational data continue to suggest yet additional therapeutic areas like neurology or allergy for povetacicept. Last year at Kidney Week, we observed a significant reduction in IgE in IgAN patients who have received povetacicept, suggesting potential applicability in IgE-related diseases like allergy. We also presented data on povetacicept in a mouse model of myasthenia gravis at the American Association of Neuromuscular and Electrodiagnostic Medicine Annual Meeting.
And next month, we will present data on povetacicept in a mouse model of autoimmune encephalitis at the American Academy of Neurology meeting. In the myasthenia models, povetacicept appeared superior to clinically relevant comparators such as SCR inhibition or B-cell depletion. We this may in part be related to some unique biophysical and/or other developmental characteristics of povetacicept, which confirm greater tissue penetration and/or distribution than wild-type TACI-Ig. Data supporting this latter statement will be part of a poster later this week at the European Lupus meeting. All together, these developments only reinforce the potential for povetacicept to have broad clinical impact in multiple serious diseases. As a reminder, povetacicept was discovered in-house by our proprietary direct evolution protein engineering platform, which has been quite productive and continue to generate novel drug candidates that may be of great future interest.
We therefore look forward to opportunities to provide further updates not only on povetacicept but also on our development pipeline in the near future. I'll now turn the call over Paul Rickey, our Chief Financial Officer.
Paul Rickey: Thank you, Stanford. And now I'll provide a brief overview of our financials for the year ended December 31, 2023. For the year ended 2023, collaboration revenue was $58.9 million compared to $30.1 million for the same period in 2022. The increase in collaboration revenue relates primarily to a $24.9 million increase in AbbVie revenue, of which $20.4 million is due to a cumulative catch-up adjustment resulting from the completion of enrollment and synergy for the amendment with AbbVie, and a $4.5 million increase in Amgen revenue, driven primarily by the expiration of Amgen's option to select a third research program. These increases were partially offset by a $0.6 million decrease in Adaptimmune revenue as we completed our final deliverables under the agreement in June 2023.
Research and development expenses for the year ended 2023, inclusive of non-cash expenses, were $80.9 million and $70.2 million for the same period in 2022. The increase of $10.7 million was driven by an $8.2 million increase in povetacicept costs primarily related to higher clinical, process development and manufacturing expenses, a $1.3 million increase in acazicolcept costs due primarily to process development and manufacturing, and a $7.7 million increase in personnel-related costs. General and administrative expenses for the year ended 2023 were $22.2 million compared to $18 million for the same period in 2022. The increase of $4.3 million was primarily attributable to increases in personnel costs and professional services. The company recorded net losses of $32.2 million and $57.8 million for the year ended 2023 and 2022, respectively.
As of December 31, 2023, Alpine's cash and investments totaled $368.2 million, which we anticipate should be sufficient to fund our planned operations into 2026. I will now hand the call back to Mitch.
Mitchell Gold: Thanks, Paul. As Stanford highlighted, we are highly encouraged by the initial IgAN data for povetacicept and are just beginning to explore the full potential of this unique, potentially best-in-class molecule. We look forward to a catalyst-rich year with data update in IgAN and other indications and the planned initiation of RAINIER, our pivotal Phase 3 study in IgAN; and DENALI, our Phase 2 study in SLE. In addition, we continue to evaluate the potential for povetacicept in additional indications. And as Stanford mentioned, we continue to invest in our immunology discovery efforts to advance the next generation of programs from our direct evolution platform. With that, I'll turn the call over to the operator for questions.
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