Synlogic Reports Second Quarter 2018 Financial Results and Provides Program Updates
- Data from Phase 1/2 studies of SYNB1618 and SYNB1020 expected by end of 2018 –
– On track to advance first immuno-oncology program into IND-enabling studies in fourth quarter of 2018 –
“Synlogic’s recent progress, including initiation of two clinical trials and multiple presentations of preclinical data, highlight the potential of Synthetic Biotic medicines across a range of diseases,” said Aoife Brennan, M.B., B.Ch., Synlogic’s interim president and chief executive officer and chief medical officer. “In the second half of 2018, we look to continue this momentum as we advance our clinical pipeline, with data expected from phase 1/2 clinical trials of our two lead programs, SYNB1020 in patients with hyperammonemia due to cirrhosis and SYNB1618 in healthy volunteers. In addition, we look forward to advancing our first immuno-oncology program into IND-enabling studies for the treatment of cancer.”
- Presentation of preclinical data highlighting potential of Synthetic Biotic medicines in immuno-oncology (IO) at the annual meeting of the
Federation of Clinical Immunology Societies(FOCIS 2018), including the platform’s broad capabilities to generate candidates that secrete or consume immunologically relevant compounds for the potential treatment of cancer and inflammation. Data presented in two sessions demonstrate that intratumorally injected E. coli Nissle was able to colonize and persist in the tumor, and that multiple functions can be engineered into a single bacterial strain. These properties support the continued development of Synthetic Biotic immunotherapies for the treatment of solid tumors, particularly “cold” tumors that may be resistant to current immunotherapies due to their lack of infiltrating immune cells or a highly immunosuppressive tumor microenvironment. Synlogicplans to advance its first immuno-oncology program into IND-enabling studies in the fourth quarter of 2018.
- Presentation of preclinical data supporting continued development of SYNB1618 for the treatment of Phenylketonuria (PKU) in a plenary session at the annual meeting of the
American Society for Microbiology(ASM Microbe 2018). The data demonstrate, in a mouse model of PKU and healthy non-human primates, that orally administered SYNB1618 can result in significant decreases in blood phenylalanine levels and dose-responsive pharmacokinetics. Synlogicis currently evaluating SYNB1618 in a Phase 1/2a clinical trial for the management of PKU and expects to report interim data from healthy volunteers before the end of 2018 and full data that includes cohorts of patients with PKU in 2019.
- Presentation of new preclinical data highlighting beneficial activity of SYNB1020 in animal model of liver disease at Digestive Disease Week (DDW 2018). The data demonstrate that, in addition to lowering systemic levels of ammonia, administration of SYNB1020 resulted in reduced indicators of liver damage, providing additional support for its continued development for the potential treatment of liver disease. SYNB1020 is currently being evaluated in a Phase 1b/2a clinical trial in patients with elevated ammonia due to cirrhosis, with topline data expected at the end of 2018.
- Strengthened balance sheet: As of
June 30, 2018, Synlogichad cash, cash equivalents, and short-term investments of $143.2 millionwhich includes $28.9 millionin net proceeds generated by a registered direct offering completed in April 2018.
- Addition to
Russell3000® Index following its annual reconstitution, providing Synlogicincreased visibility and exposure to institutional investors.
Second Quarter 2018 Financial Results
For the three months ended
Research and development expenses were
General and administrative expenses for the three months ended
For the six months ended
Total operating expenses were
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to
|Condensed Consolidated Statements of Operations|
|(in thousands)||For the three months ended||For the six months ended|
|June 30, 2018||June 30, 2017||June 30, 2018||June 30, 2017|
|Research and development||10,872||8,532||19,233||13,650|
|General and administrative||4,734||3,036||8,363||5,403|
|Total operating expenses||15,606||11,568||27,596||19,053|
|Loss from operations||(15,352)||(9,457)||(26,988)||(16,831)|
|Other income (expense), net||761||69||
Net loss per share attributable to common shareholders - basic and diluted
Weighted-average common shares used in computing net loss per share attributable to common shareholders - basic and diluted
|Condensed Consolidated Balance Sheets Data|
|June 30, 2018||December 31, 2017|
|Cash, cash equivalents and short-term investments||$||143,212||$||87,025|
|Liabilities and Stockholders' Equity|
|Total stockholders' equity||144,620||85,038|
|Total liabilities and stockholders' equity||$||161,073||$||99,699|