On May 9, 2019 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to beneficial microbes to develop novel, living medicines, reported its financial results for the first quarter ended March 31, 2019 (Press release, Synlogic, MAY 9, 2019, View Source [SID1234536066]).

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!

"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 Aoife Brennan, M.B., Ch.B. Synlogic’s president and chief executive officer. "We strengthened our scientific leadership with the appointment of two experienced drug developers, Dr. Scott Plevy, as Chief Scientific Officer, and Dr. Patricia Hurter, who joined our board of directors and brings additional relevant experience in manufacturing. In addition, we have manufactured clinical trial material in-house for our IO program and made significant advances in developing processes to reliably and reproducibly manufacture solid formulations of our orally administered Synthetic Biotic medicines. The new formulation has a more patient-friendly stability profile and provides a path to longer out-patient studies and eventual commercialization."

Recent Highlights

Corporate

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.
Pipeline

Presentation of data at the Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 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 (Free ASGCT Whitepaper) 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 Synlogic has 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. Synlogic expects 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 activator. Synlogic expects 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 AbbVie collaboration. Synlogic and AbbVieare developing an oral treatment for inflammatory bowel disease (IBD).
First Quarter 2019 Financial Results

For the three months ended March 31, 2019, Synlogic reported a consolidated net loss of $12.9 million, or $0.51 per share, compared to a consolidated net loss of $11.2 million, or $0.55 per share, for the corresponding period in 2018. The increase in net loss was primarily due to increases in compensation-related expenses due to increased headcount, as well as increases in research and development expenses to support Synlogic’s advancing clinical programs.

Research and development expenses were $10.4 million for the three months ended March 31, 2019 compared to $8.4 million for the corresponding period in 2018. The increase was primarily due to an increase in compensation-related expenses associated with increased headcount and increased expenses associated with manufacturing and pre-clinical and clinical studies of Synlogic’s Synthetic Biotic programs.

General and administrative expenses for the three months ended March 31, 2019 were $3.7 million compared to $3.6 million for the corresponding period in 2018.

Revenue was $0.3 million for the three months ended March 31, 2019 compared to $0.4 million for the same period in 2018. Revenue for both periods is associated with services performed under Synlogic’s collaboration with AbbVie to develop a Synthetic Biotic medicine for the treatment of IBD.

As of March 31, 2019, Synlogic had cash, cash equivalents, and short-term investments of $109.8 million.

Conference Call & Webcast Information

Synlogic will host a conference call and live webcast today at 5:00 pm ET today, Thursday, May 9, 2019. To access the live webcast, please visit the "Event Calendar" page within the Investors and Media section of the Synlogic website. Alternatively, investors may listen to the call by dialing +1 (844) 815-2882 from locations in the United States or +1 (213) 660-0926 from outside the United States. The conference ID number is 2154739. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors and Media section of the Synlogic website.