On May 14, 2020 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, 2020 (Press release, Alpine Immune Sciences, MAY 14, 2020, View Source [SID1234558079]).

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!

First Quarter 2020 Highlights and Subsequent Updates:

The U.S. FDA Granted Orphan Drug Designations for ALPN-101 in the Prevention and Treatment of Acute Graft Versus Host Disease. In March, the United States Food and Drug Administration (FDA) granted two orphan drug designations for ALPN-101, our first-in-class inhibitor of the CD28 and ICOS inflammation pathways, for the prevention of, and for the treatment of, acute GVHD.
ALPN-202 Study Design Presented at AACR (Free AACR Whitepaper). In April, Alpine presented the design of NEON-1, the first-in-human study of ALPN-202, our first-in-class clinical stage conditional CD28 costimulator and dual checkpoint inhibitor, at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, in the Phase I Trials in Progress Virtual Poster Session.
ALPN-101 Preclinical Data in Inflammatory Bowel Disease (IBD) Presented at 2020 Crohn’s & Colitis Congress and Digestive Disease Week 2020. ALPN-101 modulated inflammatory cytokines in vitro from human IBD peripheral blood mononuclear cells (PBMC) more potently than CD28 or ICOS single-pathway inhibitors and significantly reduced disease activity in vivo in the CD4+CD45RBhi T cell transfer mouse colitis model.
ALPN-101 and ALPN-202 Clinical Trials Ongoing. A phase 1b/2 trial of ALPN-101 in acute GVHD (BALANCE, NCT04227938) has been initiated. The NEON-1 trial of ALPN-202 (NCT04186637) is open for enrollment.
"The first quarter was a highly productive one, with now two open clinical studies for both our lead product candidates," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "We were gratified to receive orphan drug designations for ALPN-101 in acute GVHD, where current standard therapies remain inadequate to prevent or control the disease. We also reiterate our excitement over ALPN-202, which is now poised clinically to address a potential key mechanism accounting for checkpoint inhibitor resistance."

First Quarter 2020 Financial Results

As of March 31, 2020, Alpine had cash, cash equivalents, restricted cash, and short-term investments totaling $36.1 million. Net cash used in operating activities for the first quarter ended March 31, 2020 was $9.7 million compared to $11.2 million for the first quarter ended March 31, 2019. Alpine recorded a net loss of $5.5 million and $12.4 million for the first quarters ended March 31, 2020 and 2019, respectively.
Research and development expenses for the first quarter ended March 31, 2020 were $4.9 million compared to $10.4 million for the first quarter ended March 31, 2019.
General and administrative expenses for the first quarter ended March 31, 2020 were $1.8 million compared to $2.3 million for the first quarter ended March 31, 2019.
Cash Guidance

Alpine expects to have sufficient cash to fund its planned operations for at least the next 12 months, including the clinical advancement of Alpine’s lead autoimmune/inflammatory program, ALPN-101, and its lead oncology program, ALPN-202.

For additional information regarding Alpine’s planned operations, please refer to "Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operation – Liquidity and Capital Resources" in Alpine’s Quarterly Report on Form 10-Q for the three months ended March 31, 2020, which Alpine anticipates filing with the Securities and Exchange Commission on or about May 14, 2020.

About ALPN-101

ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD), a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely related costimulatory molecules with partially overlapping roles in T cell activation likely playing a role in multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, inflammatory arthritis, connective tissue disease, and multiple sclerosis, ALPN-101 demonstrates efficacy superior to agents blocking the CD28 – CD80/86 and/or ICOS – ICOSL pathways alone. A phase 1b/2 trial of ALPN-101 in acute GVHD (BALANCE, NCT04227938) has been initiated.

About ALPN-202

ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor with the potential to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. A phase 1 trial of ALPN-202 in advanced malignancies (NEON-1, NCT04186637) is open for enrollment.