Alpine Immune Sciences Provides Corporate Update and Reports Full Year 2018 Financial Results
- First Subjects Dosed in Phase I Clinical Trial for Lead Autoimmune/Inflammatory Disease Program, ALPN-101
$25 MillionPrivate Placement
- Strong Financial Position to Transition Two Lead Programs ALPN-101 and ALPN-202 into Patients
“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
Recent Corporate and Clinical Highlights
First Subjects Dosed in Phase I Healthy Volunteer Trial for Lead Autoimmune/Inflammatory Disease Program, ALPN-101: On
Strengthened Board of
- Upon closing of our
$25.3 millionprivate 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 Dechengis 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 Pharmaceuticalsand 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: 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) 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 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 Societyof Hematology’s (ASH) 60th Annual Meeting & Exposition in San Diego, CA.In addition, in an oral presentation, researchers from the lab of Indiana University Schoolof 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 ICOSligand 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 ICOSsingle pathway antagonists.
Full Year 2018 Financial Results
Collaboration revenue for the year ended
Research and development expenses for the year ended
General and administrative expenses for the year ended
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.
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
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.
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies, the timing of and results from clinical trials and pre-clinical development activities, clinical and regulatory objectives and the timing thereof, expectations regarding the sufficiency of cash to fund operations into 2021, the potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of our product candidates, the efficacy of our clinical trial designs, and our ability to successfully develop and achieve milestones in our development programs. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “intend,” and other similar expressions, among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our product candidates; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; our discovery-stage and pre-clinical programs may not advance into the clinic or result in approved products; any of our product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of competition; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the
“Transmembrane Immunomodulatory Protein,” “TIP,” “Variant Ig Domain,” “vIgD” and the Alpine logo are registered trademarks or trademarks of
|Alpine Immune Sciences, Inc.|
|Selected Condensed Consolidated Balance Sheet Data|
|December 31, 2018||December 31, 2017|
|Cash and cash equivalents||$||10,711||$||8,000|
|Total current assets||53,545||82,548|
|Total current liabilities||8,127||1,895|
|Total stockholders’ equity||44,591||78,917|
|Total liabilities, convertible preferred stock, and stockholders’ equity||54,873||85,222|
|Condensed Consolidated Statement of Operations and
Comprehensive Income (Loss) Data
|(In thousands, except share and per share amounts)||Twelve Months Ended December 31,|
|Research and development||28,970||10,626|
|General and administrative||8,362||6,079|
|Loss on sale of intangible asset||1,203||—|
|Total operating expenses||38,535||16,705|
|Loss from operations||(37,830||)||(14,974||)|
|Other income (expense):|
|Bargain purchase gain||—||6,601|
|Interest and other income||1,296||542|
|Loss before taxes||(36,853||)||(7,983||)|
|Income tax benefit (expense)||366||200|
|Basic and diluted net loss attributable to common stockholders||$||(36,487||)||$||(7,783||)|
|Comprehensive income (loss):|
|Unrealized gain (loss) on investments||46||(59||)|
|Weighted-average shares used to compute basic and diluted net loss per share attributable to common stockholders||13,849,470||6,481,665|
|Basic and diluted net loss per share attributable to common stockholders||$||(2.63||)||$||(1.20||)|