Synlogic Reports Fourth Quarter and Full Year 2017 Financial Results and Provides Business Update
– Strengthened balance sheet with
– Initiated Phase 1b/2a study evaluating SYNB1020 in patients with cirrhosis and hyperammonemia; topline data expected in 4Q 2018 –
“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.”
- Strengthened the Company’s balance sheet: As of
December 31, 2017, Synlogichad cash, cash equivalents, and short-term investments of $87.0 million. In January 2018, the company raised a further $53.7 millionin net proceeds through a public equity offering which included the full exercise of the underwriters’ option in connection with the offering. Synlogicexpects 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, Synlogicand Ginkgo Bioworks entered into an agreement to discover new living medicines to treat neurological and liver disorders.
- 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 Disordersfrom 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.
- 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 Administrationin 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.
- Advancement of collaborations with
AbbViein 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
Research and development expenses were
General and administrative expenses for the three months ended
Full Year 2017 Financial Results
For the year ended
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.
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 relate to
|Condensed Consolidated Statements of Operations|
|(in thousands)||For the three months ended||For the year ended|
|December 31, 2017||December 31, 2016||December 31, 2017||December 31, 2016|
|Research and development||7,736||5,127||30,341||15,010|
|General and administrative||4,293||1,843||12,927||6,398|
|Total operating expenses||12,029||6,970||43,268||21,408|
|Loss from operation||(11,918||)||(6,859||)||(40,824||)||(20,964||)|
|Other income(expense), net||221||11||447||10|
|Net loss per share attributable to common shareholders - basic and diluted||$||(0.74||)||$||-||$||(6.00||)||$||-|
|Weighted-average common shares used in computing net loss per share attributable to common shareholders - basic and diluted||15,871,223||-||6,724,641||-|
|Net loss per unit attributable to common unit holders - basic and diluted||$||-||$||(4.28||)||$||-||$||(13.30||)|
|Weighted-average common units used in computing net loss per unit attributable to common unit holders - basic and diluted||-||
|Condensed Consolidated Balance Sheets Data|
|December 31, 2017||
|December 31, 2016|
|Cash, cash equivalents and short-term investments||$||87,025||$||14,586|
|Liabilities, Contingently Redeemable Preferred Equity and Stockholders' Equity|
|Deferred revenue, net of current portion||668||1,112|
|Total contingently redeemable preferred equity and stockholders' equity||85,038||13,503|
|Total liabilities, contingently redeemable preferred equity and stockholders' equity||$||99,699||$||20,039|