On March 18, 2019 Alpine Immune Sciences, Inc. (Nasdaq:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, reported financial results for the year ended December 31, 2018 (Press release, Alpine Immune Sciences, MAR 18, 2019, View Source [SID1234534423]).

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"This was a year of continued execution for Alpine as we transitioned from a preclinical company to a development stage company, dosing earlier this quarter the first subjects in our Phase I healthy volunteer study of ALPN-101, our lead therapeutic for the potential treatment of autoimmune and inflammatory diseases. In addition, we continue to advance our lead oncology program, ALPN-202, preparing it for the clinic with the goal of filing an IND or IND-equivalent late this year," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "With our recently completed private placement of $25.3 million led by Decheng Capital, we are well positioned to achieve key catalysts later this year in both of our programs."

Recent Corporate and Clinical Highlights

First Subjects Dosed in Phase I Healthy Volunteer Trial for Lead Autoimmune/Inflammatory Disease Program, ALPN-101: On February 11, 2019, we announced the successful initial dosing of our first-in-human Phase I study of ALPN-101, a first-in-class dual ICOS/CD28 antagonist. The study is designed to evaluate the safety and tolerability of single- and multiple-ascending intravenous and/or subcutaneous doses of ALPN-101 in healthy volunteers. In addition, pharmacokinetics, pharmacodynamics, and exploratory biomarkers are being evaluated to help determine ALPN-101’s potential for the treatment of autoimmune and inflammatory diseases.

Completion of $25.3 Million Private Placement: On January 15, 2019, we entered into a securities purchase agreement for the sale of units consisting of shares of common stock and warrants to purchase common stock in a private placement providing gross proceeds to us of approximately $25.3 million. The private placement was led by Decheng Capital with participation from existing investors OrbiMed Advisors, Frazier Healthcare Partners, Alpine BioVentures, and BVF Partners, L.P.

Strengthened Board of Directors and Scientific Advisory Board with Recent Key Appointments:

Upon closing of our $25.3 million private placement in January 2019, Min Cui, Ph.D., Founder and Managing Director of Decheng Capital, was appointed to our Board of Directors. Dr. Cui’s focus at Decheng is on partnerships with entrepreneurs and building early stage biotechnology companies, and he currently holds Board positions at several companies. He has co-founded two companies, Pacific Pharmaceuticals and Hucon Biopharmaceuticals, where he led the research and development of key inflammatory and oncology therapies.
In addition, we appointed Vijay Kuchroo, DVM, Ph.D., Rafi Ahmed, Ph.D., James Welsh, M.D., Anne Davidson, M.B.B.S., and John Thompson, M.D. to our Scientific Advisory Board. They join a team of distinguished translational and clinical scientists in inflammatory and autoimmune diseases and cancers, including Scientific Advisory Board Chair Andrew Scharenberg, M.D., Manish Butte, M.D., Ph.D., and Paul Tumeh, M.D.
Key Preclinical Data Presentations at Medical Meetings: We showcased preclinical data for our lead programs, ALPN-101 and ALPN-202, at the following recent medical meetings:

ALPN-202 preclinical data presented at SITC (Free SITC Whitepaper): In November 2018, we presented preclinical data of our lead oncology program, ALPN-202, a PD-L1/CTLA-4 dual antagonist with PD-L1 dependent CD28 costimulation, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting in Washington, D.C. Data presented demonstrated the superiority of ALPN-202 over PD-L1 inhibition in a preclinical tumor model.
ALPN-101 GvHD preclinical data highlighted in oral presentation and posters at ASH (Free ASH Whitepaper) 2018: In December 2018, we presented positive results from multiple preclinical studies of our lead autoimmune/inflammatory program, ALPN-101, via poster presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s (ASH) (Free ASH Whitepaper) 60th Annual Meeting & Exposition in San Diego, CA. In addition, in an oral presentation, researchers from the lab of Indiana University School of Medicine’s Sophie Paczesny, M.D., Ph.D., one of our collaborators, found ALPN-101 significantly improved survival in preclinical models of acute graft versus host disease (GvHD) and highlighted the novel role of ICOS ligand in GvHD.
ALPN-101 GvHD preclinical data presented at 2019 TCT Meetings: In February 2019, we presented preclinical data for ALPN-101 GvHD at the 2019 Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR (TCT Meetings) in Houston, TX. Data presented demonstrated potent and dose-dependent suppression of GvHD in a human/NSG xenograft model, with activity superior to CD28 or ICOS single pathway antagonists.
Full Year 2018 Financial Results

As of December 31, 2018, we had cash, cash equivalents, and short-term investments totaling $52.3 million. Net cash used in operating activities for the year ended December 31, 2018 was $28.4 million compared to $16.6 million for the year ended December 31, 2017. We recorded a net loss of $36.5 million and $7.8 million for the years ended December 31, 2018 and 2017, respectively.

Collaboration revenue for the year ended December 31, 2018 was $705,000 compared to $1.7 million for the year ended December 31, 2017. The increase was primarily attributable to the timing of revenue recognized under our collaboration agreement with Kite Pharma, Inc., a Gilead (Nasdaq: GILD) company. As previously announced, under the terms of this research collaboration and license agreement, we received upfront payments of $5.5 million, which were initially recorded as deferred revenue and expensed over the period of the research term. The research term of the agreement with Kite was extended in October 2018.

Research and development expenses for the year ended December 31, 2018 were $29.0 million compared to $10.6 million for the year ended December 31, 2017. The increase was primarily attributable to an increase in direct research, contract manufacturing, and process development activities to support ALPN-101 and ALPN-202, plus increases in research personnel related to expanding research and discovery programs and associated overhead and facility costs.

General and administrative expenses for the year ended December 31, 2018 were $8.4 million compared to $6.1 million for the year ended December 31, 2017. The increase was primarily attributable to professional and legal fees and operating as a public company, in addition to personnel-related expenses and the costs associated with expanding the company’s operations as we accelerate preclinical activity.

Cash Guidance

We expect to have sufficient cash to fund operations into 2021, including the clinical advancement of our lead autoimmune/inflammatory program, ALPN-101, and our lead oncology program, ALPN-202.

About ALPN-101

ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD), and a first-in-class therapeutic simultaneously inhibiting the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely related costimulatory molecules with partially overlapping roles in T cell activation likely connected to multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, inflammatory arthritis, and multiple sclerosis, ALPN-101 demonstrates efficacy superior to blockade of the CD28 or ICOS pathways alone.

ALPN-101 was engineered using our vIgD platform, which uses directed evolution to transform native IgSF proteins into multifunctional protein therapeutics. ALPN-101 is currently enrolling a Phase I healthy volunteer trial.