On November 13, 2017 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading immunotherapy company focused on developing treatments for autoimmune/inflammatory diseases and cancer, reported a corporate update and financial results for the third quarter ended September 30, 2017 (Press release, Alpine Immune Sciences, NOV 13, 2017, View Source [SID1234521994]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"The preclinical progress in our platform continues to be encouraging as a growing amount of data supports our vIgD platform’s unique potential to create first in class molecules for inflammatory and oncology indications," said Mitchell H. Gold, M.D., Executive
Chairman and Chief Executive Officer of Alpine. "This is an exciting time at Alpine and we look forward to additional, promising catalysts throughout the coming year."
Preclinical Highlights
Alpine presented preclinical data of its lead program, ALPN-101, at the 2017 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting on November 6, 2017 in San Diego, CA, and of some of its immuno-oncology programs at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (STIC) 32nd Annual Meeting on November 10, 2017 in National Harbor, MD.
At the 2017 ACR/ARHP Annual Meeting, Alpine’s poster disclosed preclinical studies evaluating ALPN-101 program dual ICOS/CD28 antagonists generated by the company’s variant immunoglobulin domain (vlgD) platform. ICOSL vIgD-Fc fusion proteins demonstrated potent activity in an animal model of rheumatoid arthritis and in a humanized mouse model of graft vs. host disease (GvHD), suggesting that ALPN-101 candidates could have potential clinical utility in multiple inflammatory diseases.
At the SITC (Free SITC Whitepaper) 32nd Annual Meeting, Alpine’s poster disclosed distinct preclinical data from multiple novel immuno-oncology programs, all also generated from its vlgD platform. Multiple formats of vIgD-based proteins were functionally active, utilizing multiple mechanisms of action. Some suppressed tumors in an animal model. The demonstrated versatility of the vlgD platform suggests it has the potential to contribute to the next generation of immuno-oncology therapeutics.
In addition, Alpine will present posters at the following upcoming scientific meetings in 2017:
40th Annual San Antonio Breast Cancer Symposium (SABCS)
Abstract Title: ICOSL Anti-HER2 V-mAbs: Localizing Engineered ICOSL Costimulatory Agonists to HER2+ Tumors and Through Trastuzumab
Abstract #: P1-09-10
Session Title: Treatment: Novel targets and Targeted Agents
Location: San Antonio, TX
Date: December 6, 2017
Time: 5:00 PM – 7:00 PM CT
American Society of Hematology (ASH) (Free ASH Whitepaper) 59th Annual Meeting
Abstract Title: Novel Variant lg Domain (vlgD) Proteins Generated Via Directed Evolution of IgSF Domains Have Therapeutic Efficacy in Animal Models of Graft Versus Host Disease
Abstract #: 1892
Session Title: 701. Experimental Transplantation: Basic Biology, Pre-Clinical Models: Poster I
Location: Atlanta, GA
Date: December 9, 2017
Time: 5:30 PM – 7:30 PM ET
Completion of Preferred Financing and Merger with Nivalis Therapeutics
On July 24, 2017, Alpine closed its merger with Nivalis Therapeutics, with the combined company named Alpine Immune Sciences, Inc., and began trading on the NASDAQ Global market on July 25, 2017 under the ticker symbol "ALPN."
Upon completion of the merger, Alpine had approximately $90 million in cash, cash equivalents, and short-term investments. This includes $17.0 million in proceeds from the purchase of Alpine convertible preferred shares immediately prior to the merger from current Alpine investors OrbiMed Advisors, Frazier Healthcare Partners, and Alpine BioVentures at a purchase price of $12.74 per share.
Third Quarter 2017 Financial Results
Alpine ended the third quarter of 2017 with $87.2 million in cash, cash equivalents, and short-term investments compared to $11.8 million as of December 31, 2016. Net cash used in operations for the nine months ended September 30, 2017 was $10.7 million.
Revenue for the third quarter of 2017 was $0.1 million compared to $0.7 million in the third quarter of 2016. Revenues in both periods are attributable to the collaboration agreement with Kite, a Gilead (NASDAQ:GILD) company. As previously announced, this research collaboration and license agreement was extended on October 20, 2017. The extended research term does not change the $530.0 million in potential research, clinical and regulatory milestones payable to Alpine. Kite will continue to have access to two programs from Alpine’s TIP technology for use in CAR-T and TCRs during the extended research term.
Research and development expenses for the third quarter of 2017 were $2.7 million compared to $0.8 million for the same period in 2016. The $1.9 million increase was primarily attributable to increased activity in preclinical studies and the addition of operational and research personnel related to expanding research and discovery programs.
General and administrative expenses for the third quarter of 2017 were $1.9 million compared to $0.3 million for the same period in 2016. The $1.6 million increase was primarily attributable to professional and legal service fees to support the merger with Nivalis and the associated expense of transitioning to a public company structure.
The excess of the estimated fair value of net assets acquired over the acquisition consideration paid for Nivalis resulted in a bargain purchase gain to the statement of operations. This is a non-cash item.
Cash Guidance
Based on current expectations following Alpine’s recent merger, the company expects to have cash to fund operations into 2020.