On November 12, 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 third quarter ended September 30, 2019, and provided an update on its programs and progress (Press release, Synlogic, NOV 12, 2019, View Source [SID1234550963]).

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 are making good progress towards our goal of evaluating the breadth of therapeutic applications of our Synthetic Biotic platform. Notably, the recent initiation of the first clinical trial of a Synthetic Biotic medicine for the treatment of cancer represents a significant step for Synlogic," said Aoife Brennan, M.B., B.Ch., Synlogic’s president and chief executive officer. "We also continue to advance our SYNB1618 program for the treatment of phenylketonuria in an ongoing bridging study to evaluate the tolerability and activity of a solid oral formulation, and we look forward to sharing those data and our plans for the next steps in this program."

Recent Highlights
Pipeline

Clearance of Investigational New Drug (IND) application and initiation of SYNB1891 immuno-oncology (IO) clinical study. Synlogic has initiated a Phase 1 open-label, multicenter, dose escalation trial of its STING-agonist producing bacterial strain, SYNB1891, for the treatment of refractory solid tumors. The study’s primary objectives are to evaluate safety and tolerability of escalating doses of intratumorally administered SYNB1891 as a monotherapy. Once a maximum tolerated dose is established, patients will receive escalating dose levels of SYNB1891 in combination with a fixed dose of the checkpoint inhibitor, Atezolizumab, to establish a recommended Phase 2 dose for the combination regimen. Synlogic expects to have data from the monotherapy arm of the study in 2020.
Presentation of positive data from Phase 1/2a Study of SYNB1618 in patients with phenylketonuria (PKU) as well as modeling work to estimate target dosing of SYNB1618. In September, clinical data from a randomized, double-blind, placebo-controlled Phase 1/2a study of SYNB1618, which is being developed for the treatment of PKU were presented at the Annual Symposium of the Society for the Study of Inborn Errors of Metabolism (SSIEM) by Jerry Vockley, M.D. Ph.D., Professor of Pediatrics and Chief of Medical Genetics, University of Pittsburgh, and a principal investigator on the trial. The study’s primary objective was to evaluate safety and tolerability and to measure biomarkers of phenylalanine-consuming activity of multiple ascending doses of a liquid formulation of SYNB1618 in healthy volunteers and a single dose level in PKU patient cohorts. SYNB1618 was well tolerated in healthy volunteers and patients with PKU and the data demonstrated equivalent phenylalanine-consumption.
Initiation of bridging study of a solid oral formulation of SYNB1618 in healthy volunteers to establish maximum tolerated dose (MTD) for efficacy study in patients with PKU. Based on data from its Phase 1/2a study of a liquid formulation of SYNB1618, Synlogic initiated a bridging study in healthy volunteers of a new solid oral formulation to establish an MTD that would potentially enable at least a 30% lowering of blood Phe levels in PKU patients based on the company’s modeling data. With supporting data from the bridging study, Synlogic expects to advance SYNB1618 into an efficacy study in patients in the first half of 2020.
Corporate

Key appointments to Synlogic’s leadership and research and development teams
Richard Riese, M.D. Ph.D., chief medical officer, joined Synlogic in September and has assumed responsibilities for all clinical and regulatory functions from current president and CEO, Aoife Brennan.
Gregg Beloff, interim chief financial officer, was appointed in October 2019. Mr. Beloff, who has more than 20 years of experience in the life sciences industry, brings significant expertise in operational management, strategic planning, corporate and business development, fundraising and mergers and acquisitions.
Third Quarter 2019 Financial Results
As of September 30, 2019, Synlogic had cash, cash equivalents, and short- and long-term investments of $138.7 million. The Company anticipates that, based on its current operating plan, its existing cash and cash equivalents will fund company operations through 2021.

For the three months ended September 30, 2019, Synlogic reported a consolidated net loss of $13.3 million, or $0.39 per share, compared to a consolidated net loss of $10.7 million, or $0.43 per share, for the corresponding period in 2018.

Research and development expenses were $10.6 million for the three months ended September 30, 2019 compared to $9.9 million for the corresponding period in 2018. The increase was primarily due to increased clinical development costs for our SYNB1618 program.

General and administrative expenses for the three months ended September 30, 2019 were $3.9 million compared to $3.4 million for the corresponding period in 2018.

Revenues were $0.3 million for the three months ended September 30, 2019, compared to $1.8 million for the corresponding period in 2018. The revenue for both periods is associated with Synlogic’s collaboration with AbbVie to develop a Synthetic Biotic medicine for the treatment of inflammatory bowel disease. The decrease in revenue was primarily the result of the achievement of a $2.0 million milestone under a September 2018 amendment to the AbbVie agreement of which $1.8 million was recognized in revenue in the quarter ended September 30, 2018.

Conference Call & Webcast Information
Synlogic will host a conference call and live webcast today at 5:00 p.m. ET today, Tuesday, November 12, 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 3889667. 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.