On May 13, 2021 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported financial results for the first quarter ended March 31, 2021 (Press release, Alpine Immune Sciences, MAY 13, 2021, View Source [SID1234579925]).
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"The first quarter of this year has been highly productive as we continue to make strong progress across our pipeline. We look forward to sharing the first clinical data update on NEON-1, a Phase 1 dose escalation and expansion study of ALPN-202 monotherapy, at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "In addition, we continue our focus on the imminent global Phase 2 study of ALPN-101 in systemic lupus erythematosus, targeted to initiate around the middle of the year."
First Quarter 2021 and Recent Updates
ALPN-202: Conditional CD28 costimulator and dual checkpoint inhibitor
In April 2021, at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, Dr. Mark Voskoboynik from Nucleus Network and The Alfred Hospital in Melbourne, Australia, presented a Trials in Progress poster describing the ongoing first-in-human, Phase 1 clinical trial involving monotherapy with ALPN-202, the company’s lead oncology program.
In April 2021, Alpine announced an upcoming clinical data presentation on NEON-1 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting scheduled to take place June 4, 2021.
Research
In April 2021, at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, Alpine researchers demonstrated the use of directed evolution to engineer novel variant immunoglobulin domain (vIgD) Fc fusion proteins that enable tumor antigen-dependent CD28 costimulation.
General Corporate
Promotion of Remy Durand, Ph.D. to Chief Business Officer: Dr. Durand joined Alpine Immune Sciences in 2018 as Vice President, Business Development and Corporate Strategy, and has played a leading role in building the company’s partnerships with AbbVie and Adaptimmune, and has represented the company at investor meetings and conferences.
Appointed Pamela Holland, Ph.D. as Senior Vice President, Research: Dr. Holland is an experienced cancer biologist with a proven track record of successfully discovering and progressing multiple preclinical therapeutics into clinical development, most recently at Surface Oncology and Amgen.
First Quarter 2021 Financial Results
As of March 31, 2021, we had cash, cash equivalents, restricted cash, and investments totaling $115.4 million. Net cash used in operating activities for the quarter ended March 31, 2021 was $16.0 million compared to net cash used in operating activities of $9.7 million for the quarter ended March 31, 2020. We recorded net losses of $10.6 million and $5.5 million for the quarters ended March 31, 2021 and 2020, respectively.
Collaboration revenue for the quarter ended March 31, 2021 was $3.2 million and related to our agreement with AbbVie, compared to $1.1 million related to our agreement with Adaptimmune for the quarter ended March 31, 2020.
Research and development expenses for the quarter ended March 31, 2021 were $10.4 million compared to $4.9 million for the quarter ended March 31, 2020. The increase was primarily attributable to increases in contract manufacturing and process development of our product candidates, clinical trial activities, and personnel-related expenses.
General and administrative expenses for the quarter ended March 31, 2021 were $3.3 million compared to $1.8 million for the quarter ended March 31, 2020. The increase was primarily attributable to increases in professional and legal services, personnel-related expenses, and insurance and facility costs to support the growth and expansion of our business.
Alpine expects that its current cash resources, combined with the potential $75 million in pre-option exercise milestones payable under its option and license agreement with AbbVie, for the development and commercialization of ALPN-101, are sufficient to fund Alpine’s planned operations through 2023.