On August 11, 2022 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune and inflammatory diseases, reported financial results for the second quarter ended June 30, 2022 (Press release, Alpine Immune Sciences, AUG 11, 2022, View Source [SID1234618127]).

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"We are pleased with our productive second quarter that included the presentation of encouraging clinical data across our pipeline of novel autoimmune and immuno-oncology candidates and the continued strengthening of our company with the additions of Dr. Sandler to our management team and Dr. Drapa to our board of directors," said Mitchell H. Gold, MD, Executive Chairman and Chief Executive Officer of Alpine. "Promising first-in-human data for ALPN-303, our potentially best-in-class dual BAFF/APRIL inhibitor, were presented at the 2022 European Alliance of Associations for Rheumatology (EULAR) Congress. We look forward to sharing a more detailed clinical update later in the year to be followed by multiple patient-based studies. Our lead immuno-oncology candidate, davoceticept, has demonstrated a deepening reduction in tumor volume as a monotherapy and focused expansion cohorts have been initiated. In addition, we are pleased to have had the partial clinical hold removed on the NEON-2 trial of davoceticept in combination with pembrolizumab and we plan to report initial data from this combination later this year."

Second Quarter 2022 and Recent Pipeline Updates

ALPN-303

Preliminary data from the first-in-human, phase 1 study of ALPN-303 in healthy volunteers were included in a poster presentation at the 2022 European Alliance of Associations for Rheumatology (EULAR) Congress. ALPN-303 has significantly improved potency against the B cell cytokines BAFF and APRIL, superior to related inhibitors including wild-type TACI-Fc’s. In addition, the ongoing phase 1 study demonstrates that ALPN-303 has been well tolerated to-date and has exhibited highly encouraging preliminary pharmacodynamic reductions in circulating immunoglobulins.
Initiation of up to three basket trials in hematologic, renal, and dermatologic indications and a phase 2 study in systemic lupus erythematosus (SLE) is anticipated beginning in the first half of 2023, updated from end of 2022 due, in part, to delays in enrollment in our phase 1 study related to the COVID-19 pandemic in Australia earlier this year. We plan to provide a more detailed clinical update from the phase 1 study in the third quarter of 2022 and anticipate initial clinical data from the basket trials in the second half of 2023.
Davoceticept

Davoceticept monotherapy dose escalation data (NEON-1) were presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, demonstrating tumor volume reduction in 23% of evaluable participants despite a highly heterogeneous, heavily pretreated, advanced solid tumor population. Monotherapy expansion cohorts are currently open for enrollment with a particular interest in renal cell carcinoma, given the observed preliminary activity in this setting.
FDA removed the partial clinical hold on the NEON-2 trial of davoceticept in combination with pembrolizumab after review of the Company’s Complete Response, which included a comprehensive review of the davoceticept safety database, as well as a revised investigator brochure and study protocol. Preliminary data from the NEON-2 combination trial is anticipated in the second half of 2022.
Corporate

Andrew Sandler, MD was appointed Chief Medical Officer of Alpine effective August 17, 2022. Dr. Sandler brings over 25 years of industry experience and clinical development expertise and leadership to the Alpine team. Dr. Sandler joins Alpine from Kiadis Pharma, a Sanofi Company, where he was Chief Medical Officer.
Jörn Drappa, MD, PhD, a 20-year industry veteran with extensive global clinical development leadership experience in autoimmune and inflammatory diseases, joined the Alpine Board of Directors. Dr. Drappa co-founded Viela Bio, a biotechnology company focused on the discovery, development and commercialization of treatments for autoimmune and severe inflammatory diseases, and served as its Head of R&D and Chief Medical Officer through its acquisition by Horizon Therapeutics in March 2021 for $3.1 billion.
Second Quarter 2022 Financial Results

As of June 30, 2022, Alpine’s cash, cash equivalents, and investments totaled $201.2 million. The Company recorded net losses of $18.1 million and $11.0 million for the quarters ended June 30, 2022 and 2021, respectively.

Collaboration revenue for the second quarter ended June 30, 2022 was $5.3 million compared to $7.2 million for the second quarter ended June 30, 2021. The 2022 amounts were primarily attributable to revenue recognized under the Company’s AbbVie and Horizon Agreements, while 2021 revenue recognized solely relates to the AbbVie collaboration.

Research and development expenses for the second quarter ended June 30, 2022 were $17.6 million compared to $14.6 million for the second quarter ended June 30, 2021. The increase was primarily attributable to the Company’s Synergy, NEON, and ALPN-303 studies, and increased personnel costs and direct research activities. These increases were partially offset by a decrease in contract manufacturing and process development for ALPN-303.

General and administrative expenses for the second quarter ended June 30, 2022 were $4.2 million compared to $3.3 million for the second quarter ended June 30, 2021. The increase was primarily attributable to increases in personnel costs.

The Company expects that its current cash resources will be sufficient to fund its planned operations into 2024.