Alpine transitions to clinical-stage company
Completed financing to fund further development of both lead
programs
SEATTLE–(BUSINESS WIRE)–Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage
immunotherapy company focused on developing innovative treatments for
cancer, autoimmune/inflammatory, and other diseases, today provided a
corporate update and reported financial results for the first quarter
ended March 31, 2019.
“The first quarter of 2019 was a significant one for Alpine as we
transitioned into a clinical stage company by initiating the
first-in-human Phase I study of our lead autoimmune/inflammatory disease
program ALPN-101,” said Mitchell H. Gold, MD, Executive Chairman and
Chief Executive Officer of Alpine. “Building on this momentum, we are on
track to have two programs in clinical trials as we expect to file for
authorization to begin a Phase I study of our lead oncology program,
ALPN-202, by the end of this year. Our team is focused on delivering the
next generation of immunotherapies to patients suffering from
debilitating and deadly diseases and continues to execute our
pre-clinical and clinical strategy.”
Recent Corporate and Clinical Highlights
First Subjects Dosed in Phase I Clinical Trial for Lead
Autoimmune/Inflammatory Disease Program ALPN-101: Alpine announced
successful initiation of dosing in its first-in-human Phase I study of
ALPN-101, a first-in-class dual ICOS/CD28 antagonist, this past
February. This study is evaluating the safety and tolerability of
single- and multiple-ascending intravenous and subcutaneous doses of
ALPN-101 in healthy volunteers. Pharmacokinetics, pharmacodynamics, and
exploratory biomarkers are also being evaluated to help determine
ALPN-101’s potential for the treatment of autoimmune/inflammatory
diseases.
Closed $25 Million Private Placement and Min Cui, PhD appointed to
Alpine’s Board of Directors: Alpine entered into a definitive
securities purchase agreement for the sale of units consisting of shares
of common stock and warrants to purchase common stock in a private
placement resulting in gross proceeds to the Company 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. Min Cui, PhD,
Founder and Managing Director of Decheng Capital, was appointed to
Alpine’s Board of Directors.
Appointment of Stanford Peng, MD, to President and Head of Research
and Development: Effective April 16, 2019, Dr. Peng was appointed
President and Head of Research and Development. Dr. Peng is an industry
veteran who has led Alpine’s research and development activities since
late 2016, advancing lead program ALPN-101 into the clinic and
positioning ALPN-202, Alpine’s lead oncology program, to be submitted
for clinical trial authorization later this year.
Jan Hillson, MD, Appointed as Senior Vice President, Clinical Development:
During the first quarter of 2019, Alpine appointed Dr. Hillson to Senior
Vice President, Clinical Development. Dr. Hillson brings with her more
than two decades of experience in academic rheumatology research,
patient care, and teaching, and more than a decade directing strategy
and operations of clinical research and translational medicine programs.
Prior to joining Alpine, Dr. Hillson was Senior Vice President of Drug
Development for ChemoCentryx, and earlier, she served as Vice President
of Clinical and Translational Research at Momenta Pharmaceuticals. She
has served in senior roles with ZymoGenetics/Bristol Myers Squibb and
Xcyte Therapies and was a member of the Clinical Faculty at Harvard
Medical School (Cambridge Health Alliance), Assistant Professor at the
University of Washington, and Division Head at Virginia Mason Medical
Center. Dr. Hillson is a licensed rheumatologist and continues to care
for patients. She received her MD from Stanford School of Medicine, an
MS from the California Institute of Technology, an MS in Marine
Chemistry from Scripps Institute of Oceanography, and a BS from Michigan
State University.
First Quarter 2019 Financial Results
As of March 31, 2019, Alpine had cash, cash equivalents, and short-term
investments totaling $64.0 million. Net cash used in operating
activities for the first quarter ended March 31, 2019 was $11.2 million
compared to $4.4 million for the first quarter ended March 31, 2018.
Alpine recorded a net loss of $12.4 million and $5.3 million for the
first quarters ended March 31, 2019 and 2018, respectively.
Research and development expenses for the first quarter ended March 31,
2019 were $10.4 million compared to $3.8 million for the first quarter
ended March 31, 2018. The increase was primarily attributable to an
increase in direct research, contract manufacturing, and nonclinical
development activities to support ALPN-101 and ALPN-202, plus increases
in development personnel supporting Alpine’s programs and associated
overhead and facility costs.
General and administrative expenses for the first quarter ended
March 31, 2019 were $2.3 million compared to $2.1 million for the first
quarter ended March 31, 2018. The increase was primarily attributable to
professional and legal fees related to operating as a public company, in
addition to personnel-related expenses and the costs associated with
expanding the company’s operations as we accelerate development and
clinical activities.
Cash Guidance
Alpine expects to have sufficient cash to fund operations into 2021,
including the clinical advancement of Alpine’s lead
autoimmune/inflammatory program, ALPN-101, and its 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 Alpine’s vIgD platform, which uses
directed evolution to transform native IgSF proteins into
multifunctional protein therapeutics. ALPN-101 is currently enrolling a
first-in-human Phase I healthy volunteer trial.
About Alpine Immune Sciences, Inc.
Alpine Immune Sciences, Inc. is committed to leading a new wave of
functional immune therapeutics. Alpine is employing directed evolution
to create potentially powerful multifunctional immunotherapies to
improve patients’ lives. Alpine has two lead programs. The first,
ALPN-101 for autoimmune/inflammatory diseases, is a dual ICOS/CD28
antagonist, engineered to reduce pathogenic immune responses. The
second, ALPN-202 for cancer, is a dual PD-L1/CTLA-4 antagonist and
PD-L1-dependent CD28 costimulator intended to combine checkpoint
inhibition with T cell costimulation – an approach currently absent from
approved checkpoint therapies. Alpine is backed by world-class research
and development capabilities, a highly-productive scientific platform,
and a proven management team. For more information, visit www.alpineimmunesciences.com.
Forward-Looking Statements
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 Securities and Exchange Commission. These
forward-looking statements speak only as of the date hereof and we
undertake no obligation to update forward-looking statements, and
readers are cautioned not to place undue reliance on such
forward-looking statements.
“Transmembrane Immunomodulatory Protein,” “TIP,” “Variant Ig Domain,”
“vIgD” and the Alpine logo are registered trademarks or trademarks of
Alpine Immune Sciences, Inc. in various jurisdictions.
| Alpine Immune Sciences, Inc. | |||||||||
| Selected Condensed Consolidated Balance Sheet Data | |||||||||
| (In thousands) | |||||||||
| March 31, 2019 |
December 31, |
||||||||
| (unaudited) | |||||||||
| Cash and cash equivalents | $ | 41,437 | $ | 10,711 | |||||
| Short-term investments | 22,519 | 41,592 | |||||||
| Total current assets | 64,895 | 53,545 | |||||||
| Total assets | 67,105 | 54,873 | |||||||
| Total current liabilities | 8,848 | 8,127 | |||||||
| Total stockholders’ equity | 56,583 | 44,591 | |||||||
| Total liabilities and stockholders’ equity | 67,105 | 54,873 | |||||||
|
Condensed Consolidated Statement of Operations and
Comprehensive Income (Loss) Data |
|||||||||
| (In thousands, except share and per share amounts) | Three Months Ended March 31, | ||||||||
| 2019 | 2018 | ||||||||
| (unaudited) | |||||||||
| Collaboration revenue | $ | — | $ | 315 | |||||
| Operating expenses: | |||||||||
| Research and development | 10,350 | 3,792 | |||||||
| General and administrative | 2,345 | 2,108 | |||||||
| Total operating expenses | 12,695 | 5,900 | |||||||
| Loss from operations | (12,695 | ) | (5,585 | ) | |||||
| Other income (expense): | |||||||||
| Interest expense | (70 | ) | (78 | ) | |||||
| Interest and other income | 384 | 305 | |||||||
| Loss before taxes | (12,381 | ) | (5,358 | ) | |||||
| Income tax benefit (expense) | — | 52 | |||||||
| Net loss | $ | (12,381 | ) | $ | (5,306 | ) | |||
| Comprehensive income (loss): | |||||||||
| Unrealized gain (loss) on investments | 15 | (46 | ) | ||||||
| Unrealized loss on foreign currency translation | (14 | ) | — | ||||||
| Comprehensive loss | $ | (12,380 | ) | $ | (5,352 | ) | |||
|
Weighted-average shares used to compute basic and diluted net loss per share |
17,671,918 | 13,844,731 | |||||||
| Basic and diluted net loss per share | $ | (0.70 | ) | $ | (0.38 | ) | |||
Contacts
Alpine Immune Sciences Inc.
Investor Relations:
Pure
Communications
Courtney Dugan, 212-257-6723
cdugan@purecommunications.com
Media
Relations:
Pure Communications
Jennifer Paganelli, 347-658-8290
jpaganelli@purecommunications.com