On November 13, 2018 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, 2018, and provided an update on its programs (Press release, Synlogic, NOV 13, 2018, View Source [SID1234531263]).

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"This is an exciting time for Synlogic, as we continue to explore the breadth of our platform. We have advanced SYNB1891, our dual innate immune activator for the treatment of cancer into IND-enabling studies," said Aoife Brennan, M.B., B.Ch., Synlogic’s president and chief executive officer. "Our two orally administered Synthetic Biotic medicines, SYNB1618 for the treatment of phenylketonuria and SYNB1020 for the treatment of hyperammonemia, have demonstrated proof of mechanism in healthy volunteers and we look forward to clinical data from the ongoing clinical trials in patients in 2019."

Recent Highlights
Pipeline

Presentation of preclinical data highlighting potential of Synthetic Biotic medicines in immuno-oncology (IO) and declaration of first IO clinical candidate at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting. Data presented at the meeting demonstrate the platform’s potential for the treatment of cancer and inflammation and specifically highlight the unique advantages of Synlogic’s approach to stimulate the innate immune system. Based on preclinical data Synlogic is advancing SYNB1891, a STING-agonist producing synthetic biotic strain, into IND-enabling studies. Synlogic hosted an investor and analyst event at the SITC (Free SITC Whitepaper) annual meeting, featuring presentations by key opinion leaders (KOLs), and members of Synlogic management who outlined development plans for SYNB1891. A webcast of the event is available on the Synlogic website.
Presentation of preclinical data supporting continued development of SYNB1020 for the treatment of liver disease at the American Association for the Study of Liver Diseases (AASLD) annual meeting. Preclinical data were presented demonstrating dose dependent lowering of blood ammonia by Synthetic Biotic strains designed to consume ammonia and produce arginine in a rat bile duct ligation model confirming earlier preclinical observations in mouse models of liver disease. In addition, data were presented from studies conducted by Synlogic to establish ammonia measurement parameters and ammonia levels in healthy volunteers at clinical sites that are participating in Synlogic’s ongoing Phase 1b/2a clinical trial of SYNB1020 in patients with cirrhosis and elevated ammonia. Topline data from this clinical trial are now expected in mid-2019 due to slower than expected rates of initiation of clinical trial sites and patient enrollment.
Announcement of positive interim data from healthy volunteer (HV) arm of its ongoing Phase 1/2a clinical trial evaluating SYNB1618 for the treatment of Phenylketonuria (PKU): Data established a go-forward dose for the treatment arm in patients with PKU and demonstrated a statistically significant, dose-dependent effect on treatment-associated biomarkers, indicating proof-of-mechanism. Synlogic also published preclinical data identifying these same biomarkers in Nature Biotechnology, further supporting SYNB1618’s continued development. The Company continues to evaluate SYNB1618 in patients with PKU in its ongoing Phase 1/2a study and expects to report topline data from this trial in mid-2019.
Corporate

Appointed Aoife Brennan, M.B., B.Ch., as president and chief executive officer: Dr. Brennan had served as interim president and chief executive officer since May 2018 and joined Synlogic as chief medical officer in 2016.
Third Quarter 2018 Financial Results
As of September 30, 2018, Synlogic had cash, cash equivalents, and short-term investments of $132.6 million.

For the three months ended September 30, 2018, Synlogic reported a consolidated net loss of $10.7 million, or $0.43 per share, compared to a consolidated net loss of $11.9 million, or $1.66 per share, for the corresponding period in 2017.

Research and development expenses were $9.9 million for the three months ended September 30, 2018 compared to $9.0 million for the corresponding period in 2017.

General and administrative expenses for the three months ended September 30, 2018 were $3.4 million compared to $3.2 million for the corresponding period in 2017.

Revenues were $1.8 million for the three months ended September 30, 2018, compared to $0.1 million for the corresponding period in 2017. 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 increase 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.

Nine-months Results
For the nine months ended September 30, 2018, the consolidated net loss was $36.5 million, or $1.56 per share, compared to a consolidated net loss of $28.7 million, or $7.87 per share, for the corresponding period in 2017.

Total operating expenses were $40.9 million for the nine months ended September 30, 2018, compared to $31.2 million for the corresponding period in 2017. The increase in operating expenses was primarily due to compensation-related expenses associated with increased headcount and increased external costs associated with development of Synlogic’s Synthetic Biotic programs.

Conference Call & Webcast Information
Synlogic will host a conference call and live webcast today at 5:00 p.m. ET today, Tuesday, November 13, 2018. 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 2674209. 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.