Synlogic Reports Third Quarter 2017 Financial Results and Recent Progress
- Reported Positive Top-line Results from Phase 1 Clinical Study of
- Received Orphan Drug Designation for SYNB1618, a Synthetic BioticTM Medicine for the Treatment of Phenylketonuria -
“In our first months as a public company, we have achieved significant progress in advancing our pipeline with our recent release of positive data from the first clinical trial of our Synthetic Biotic medicine SYNB1020 for hyperammonemia,” said JC Gutiérrez-Ramos, Ph.D., Synlogic’s president and chief executive officer. “We are building an organization with the goal of bringing rational drug design and pharmacologically driven drug development to a new class of living medicines. We are focused internally on developing treatments for inborn errors of metabolism and we look forward to advancing our two lead programs into clinical studies in patients in 2018.”
- Reported positive top-line clinical data from Synlogic’s Phase 1
clinical study of SYNB1020, an orally delivered, first-in-class,
Synthetic Biotic medicine designed to treat elevated blood ammonia
levels (hyperammonemia) in genetic urea cycle disorders (UCD) or in
chronic liver disease
- The trial successfully met its primary objectives, demonstrating safety and tolerability in healthy volunteers and identifying the maximum tolerated dose. SYNB1020 did not colonize and was cleared within the expected timeframe in subjects who had completed follow-up. Viability and evidence of mechanistic activity of the Synthetic Biotic was demonstrated in feces of subjects who received SYNB1020, but not in control subjects. Furthermore, in the multiple ascending dose component of the Phase 1 study, daily dosing of SYNB1020 over 14 days in healthy volunteers enabled identification of a dose-response relationship between SYNB1020 oral administration and changes in a nitrogen endpoint in plasma which was found to be statistically significant in the highest dose cohort compared to placebo
- The Company plans to initiate a Phase 1b/2a study of SYNB1020 in patients with liver cirrhosis and elevated ammonia in the first half of 2018 and a second Phase 1b/2a study in patients with UCDs.
- Received Orphan Drug Designation from the
U.S. Food and Drug Administration( FDA) for SYNB1618, an orally delivered, Synthetic Biotic medicine designed for treatment of phenylketonuria (PKU), an inborn error of metabolism caused by a mutation of the gene that breaks down the amino acid phenylalanine (Phe).
Reserved for treatments of rare diseases affecting fewer than
200,000 people in the U.S., Orphan Drug Designation offers
FDAassistance in trial design and grants development and commercial incentives, including eligibility for a seven-year period of market exclusivity in the U.S., if approved. In 2018, Synlogicplans to initiate a clinical trial to evaluate SYNB1618 for the potential treatment of PKU.
- Reserved for treatments of rare diseases affecting fewer than 200,000 people in the U.S., Orphan Drug Designation offers
- Completed merger and began trading on the
NASDAQ Capital Marketunder the ticker symbol “SYBX”.
August 28, 2017, Synlogic, Inc.and Mirna Therapeutics, Inc.closed the merger of the two companies.
- Strengthened leadership team with two key additions.
Synlogicappointed two experienced executives to key leadership roles: Andrew Gengosas Chief Operating Officer and Head of Corporate Development; and Adam Thomasas Chief Human Resources Officer.
Third Quarter 2017 Financial Results
For the three months ended
Research and development expenses were
General and administrative expenses for the three months 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 two lead programs target a group of rare metabolic diseases – inborn errors of metabolism (IEM). Patients with these diseases are born with a faulty gene, inhibiting the body’s ability to break down commonly occurring by-products of digestion that then 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
|Condensed Consolidated Statements of Operations|
|For the three months ended||For the nine months ended|
|September 30, 2017||September 30, 2016||September 30, 2017||September 30, 2016|
|Research and development||8,955||4,133||22,605||9,883|
|General and administrative||3,231||1,286||8,634||4,555|
|Total operating expenses||12,186||5,419||31,239||14,438|
|Loss from operation||(12,075||)||(5,308||)||(28,906||)||(14,105||)|
|Other income(expense), net||151||2||226||(1||)|
|Net loss per share attributable to common shareholders - basic and diluted||$||(1.66||)||$||-||$||(7.87||)||$||-|
|Weighted-average common shares used in computing net loss per share attributable to common shareholders - basic and diluted||7,169,241||-||3,642,125||-|
|Net loss per share attributable to common unitholders - basic and diluted||$||-||$||(3.33||)||$||-||$||(9.17||)|
|Weighted-average common shares used in computing net loss per share attributable to common shareholders - basic and diluted||-||
|Condensed Consolidated Balance Sheets Data|
|September 30, 2017||December 31, 2016|
|Cash, cash equivalents and short-term investments||$||96,572||$||14,586|
|Liabilities, Contingently Redeemable Preferred Shares/Units and Equity|
|Deferred revenue, net of current portion||779||1,112|
|Total equity and contingently redeemable preferred shares||95,565||13,503|
|Total liabilities and equity||$||104,470||$||20,039|