On March 20, 2018 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to probiotics to develop novel, living medicines, reported its financial results for the fourth quarter and full year ended December 31, 2017 (Press release, Synlogic, MAR 20, 2018, View Source [SID1234524914]).
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"In 2018, we are well positioned to continue to advance our platform, and with the initiation of clinical trials for our Synthetic BioticTM medicines, SYNB1020 and SYNB1618, for the treatment of hyperammonemia and PKU we have the potential to establish proof of concept in patients in two different diseases by year-end," said JC Gutiérrez-Ramos, Ph.D., Synlogic’s president and chief executive officer. "These data will be key to determine if SYNB1020 and SYNB1618 could help patients manage their diseases and have the potential to demonstrate the power of our Synthetic Biotic platform."
Dr. Gutiérrez-Ramos continued. "Our strong cash position also enables us to expand our pipeline. Based on our promising preclinical data, we plan to advance two Synthetic Biotic candidates into IND-enabling studies, broadening the platform’s scope into immuno-oncology and adding an additional application in inborn errors of metabolism for the treatment of maple syrup urine disease."
Recent Highlights
Corporate
Strengthened the Company’s balance sheet: As of December 31, 2017, Synlogic had cash, cash equivalents, and short-term investments of $87.0 million. In January 2018, the company raised a further $53.7 million in net proceeds through a public equity offering which included the full exercise of the underwriters’ option in connection with the offering. Synlogic expects its current cash, cash equivalents and marketable securities position will be sufficient to fund operations through 2019 based on its current business plan.
Established collaboration with Ginkgo Bioworks: In November 2017, Synlogic and Ginkgo Bioworks entered into an agreement to discover new living medicines to treat neurological and liver disorders.
Pipeline
Initiation of Phase 1b/2a study to evaluate SYNB1020, which is being developed to treat hyperammonemia, in patients with cirrhosis and elevated blood ammonia. The study is open and screening subjects.
Presentation of expanded clinical data set from first-in-human study in healthy volunteers of a Synthetic Biotic medicine, SYNB1020 for the treatment of hyperammonemia. In March 2018, additional data were presented at the annual meeting of the Society for Inherited Metabolic Disorders from the first-in-human clinical trial of a Synthetic Biotic medicine, SYNB1020 for the treatment of hyperammonemia. The data demonstrated that SYNB1020 was safe and well tolerated in this population and demonstrated proof of mechanism.
2018 Priorities
Pipeline
Initiation of a Phase 1/2a SAD/MAD study to evaluate SYNB1618, an orally administered, Synthetic Biotic medicine designed for the treatment of phenylketonuria (PKU) in healthy volunteers and patients with PKU in the first half of 2018, with interim data expected in the second half of 2018.
Presentation of top-line data from Phase 1b/2a study of SYNB1020 in patients with cirrhosis and elevated blood ammonia by year end. With ammonia-lowering data in this patient population the Company plans to initiate a Phase 1b/2a study in patients with urea cycle disorders.
Advancement of an additional IEM program for maple syrup urine disease (MSUD), and an immuno-oncology program candidate into preclinical studies designed to enable the filing of Investigational New Drug applications with the U.S. Federal Drug Administration in 2019.
Presentation of additional data at major scientific and medical meetings throughout the year demonstrating the breadth of Synlogic’s Synthetic Biotic platform in new indications, including data from the company’s research and preclinical immuno-oncology program.
Corporate
Advancement of collaborations with AbbVie in inflammatory bowel disease (IBD) and Ginkgo Bioworks in neurological and liver disease.
Continued exploration of additional strategic opportunities to expand the platform’s reach.
Fourth Quarter 2017 Financial Results
For the three months ended December 31, 2017, Synlogic reported a consolidated net loss of $11.7 million, or $0.74 per share, compared to a net loss of $6.8 million, or $4.28 per unit, for the corresponding period in 2016. The increase in net loss for the fourth quarter was primarily due to increases in compensation-related expenses as Synlogic continues to grow its employee headcount and hire into key positions to support its corporate goals, as well as increases in research and development expenses to support its advancing clinical programs.
Research and development expenses were $7.7 million for the three months ended December 31, 2017 compared to $5.1 million for the corresponding period in 2016. The increase was primarily due to an increase in compensation-related expenses associated with increased headcount, increased external costs associated with process and formulation development, pre-clinical and clinical studies and acceleration of leasehold improvements associated with exiting Synlogic’s former facility.
General and administrative expenses for the three months ended December 31, 2017 were $4.3 million compared to $1.8 million for the corresponding period in 2016. The increase was primarily due to increases in compensation-related expenses associated with increased headcount and increases in expenses related to being a newly public company, including audit, legal and investor relations.
Revenue was $0.1 million for the three months ended December 31, 2017 and December 31, 2016. Revenue is associated with the upfront, nonrefundable $2.0 million payment from the Company’s collaboration with AbbVie, to develop a Synthetic Biotic medicine for the treatment of inflammatory bowel disease (IBD), which is being recognized on a straight-line basis over the expected term of the research collaboration.
As of December 31, 2017, Synlogic had cash, cash equivalents, and short-term investments of $87.0 million.
Full Year 2017 Financial Results
For the year ended December 31, 2017, consolidated net loss was $40.4 million, or $6.00 per share, compared to a consolidated net loss of $21.0 million, or $13.30 per unit, for the year ended December 31, 2016. Revenues were $2.4 million for the year ended December 31, 2017, compared to $0.4 million for the same period in 2016. The increase in revenues was due to achievement of the first development milestone in the Company’s collaboration with AbbVie which resulted in a $2.0 million payment to Synlogic in May 2017. Total operating expenses were $43.3 million for the year ended December 31, 2017, compared to $21.4 million for the same period in 2016. The increase in operating expenses was primarily due to compensation-related expenses associated with increased headcount, increased external costs associated with development of Synlogic’s Synthetic Biotic programs including process and formulation development, pre-clinical and clinical studies as well as increased general and administrative expenses as a consequence of becoming a public company.
About Synthetic Biotic Medicines
Synlogic’s innovative new class of Synthetic Biotic medicines leverages the tools and principles of synthetic biology to genetically engineer probiotic microbes to perform or deliver critical functions missing or damaged due to disease. The company’s lead programs target diseases, including inborn errors of metabolism (IEMs), in which the body’s ability to break down commonly occurring by-products of digestion is impaired. These by-products, or metabolites, accumulate to toxic levels and cause serious health consequences. When delivered orally, these medicines can act from the gut to compensate for the dysfunctional metabolic pathway and have a systemic effect. Synthetic Biotic medicines are designed to clear toxic metabolites associated with specific metabolic diseases and have the potential to significantly improve symptoms of disease for affected patients