Synlogic Reports First Quarter 2019 Financial Results and Provides Business Update
– Company will host a conference call and webcast at
“We made significant progress on our 2019 goals in the first quarter of
the year providing a strong foundation for the continued development of
our Synthetic Biotic™ platform and clinical pipeline,” said
- Appointment of
Scott Plevy, M.D., as Synlogic’s Chief Scientific Officer. Dr. Plevy has responsibility for Synlogic’s research organization. He most recently served as Vice President, Gastroenterology Disease Area Leader and IL-23 Pathway Leader at Janssen Research & Development, LLC, after a successful career in academia. He has served as the lead investigator on multiple early-phase clinical trials, published on a breadth of topics from disease-specific targets to basic immunology and molecular biology, and performed translational research to advance the understanding of novel immunologic interventions in inflammatory bowel disease, other inflammatory conditions, and microbiome-related diseases.
- Appointment of
Patricia N. Hurter, Ph.D., to Synlogic’s board of directors. Dr. Hurter served as Senior Vice President at Vertex from 2011 to 2019, during which time her responsibilities grew to include all CMC and preclinical development activities of Vertex’s R&D portfolio, as well as the internal GMP manufacturing facility that provides drug substance and product for clinical development and commercial supply. Dr. Hurter also served as Interim Head of Global Regulatory Affairs at Vertex and played a leadership role in the development and commercialization of four transformative therapies for Vertex. Prior to joining Vertex, Dr. Hurter was Director, Formulation Design and Characterization for Merck.
- Presentation of data at the Annual Meeting of the
American Society of Gene and Cell Therapy(ASGCT) demonstrating the development of a robust and reproducible process to generate a solid oral formulation of Synlogic’s Synthetic Bioticmedicine for future studies and potential commercial use. The ASGCT presentation focused on preparation and characteristics of a solid oral preparation of SYNB1618, Synlogic’s Synthetic Biotic medicine for the treatment of phenylketonuria (PKU). The data demonstrate that Synlogichas developed a robust and reproducible process to generate a solid formulation of SYNB1618 with minimal impact on cell viability and phenylalanine consuming activity compared to a liquid formulation that is currently being evaluated in an ongoing Phase 1 /2a clinical study in patients with PKU. Synlogicexpects to have data from the Phase 1 /2a study in patients in the third quarter of 2019.
- Publication in Science Translational Medicine of first in human clinical data and supporting preclinical data from investigational Synthetic Biotic candidate, SYNB1020. The data support the continued development of SYNB1020 which is currently being evaluated in a Phase 1b/2a clinical trial in patients with cirrhosis and elevated blood ammonia with data expected in the third quarter of 2019.
- In-house manufacturing of clinical trial material for Synlogic’s
first immuno-oncology program, SYNB1891, a dual innate immune
Synlogicexpects to file an investigational new drug (IND) application for SYNB1891 in the second half of 2019.
- Advancement of investigational Synthetic Biotic medicines to lead
optimization stage in
AbbViecollaboration. Synlogicand AbbVieare developing an oral treatment for inflammatory bowel disease (IBD).
First Quarter 2019 Financial Results
For the three months ended
Research and development expenses were
General and administrative expenses for the three months ended
Conference Call & Webcast Information
This press release contains “forward-looking statements” that involve
substantial risks and uncertainties for purposes of the safe harbor
provided by the Private Securities Litigation Reform Act of 1995. All
statements, other than statements of historical facts, included in this
press release regarding strategy, future operations, future financial
position, future revenue, projected expenses, prospects, plans and
objectives of management are forward-looking statements. In addition,
when or if used in this press release, the words “may,” “could,”
“should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,”
“plan,” “predict” and similar expressions and their variants, as they
|Condensed Consolidated Statements of Operations|
|(in thousands except share and per share data)||For the three months ended|
|March 31, 2019||March 31, 2018|
|Research and development||10,384||8,361|
|General and administrative||3,651||3,629|
|Total operating expenses||14,035||11,990|
|Loss from operations||(13,697||)||(11,636||)|
|Other income(expense), net||751||471|
Net loss per share attributable to common
Weighted-average common shares used in
|Condensed Consolidated Balance Sheets|
|March 31, 2019||December 31, 2018|
|Cash, cash equivalents and short-term investments||$||109,835||$||122,729|
|Liabilities and Stockholders' Equity|
|Total stockholders' equity||112,209||124,098|
|Total liabilities and stockholders' equity||$||144,019||$||140,340|