Synlogic Reports First Quarter 2018 Financial Results and Provides Business Update
– Treated first subject in clinical trials of two Synthetic BioticTM medicines, SYNB1020 and SYNB1618; both studies expected to generate data in 2018 –
- Leadership Transition: On
May 10, 2018, Synlogicannounced a CEO transition; Chief Medical Officer, Aoife Brennan, M.B., B.Ch., was appointed to serve as Interim President and Chief Executive Officer as successor to Jose-Carlos Gutiérrez-Ramos, Ph.D.; Peter Barrett, Ph.D., the Chairman of Synlogic’s board of directors will serve as Executive Chairman and oversee a Board committee to conduct a search for a permanent CEO.
- Strengthened Company’s balance sheet: As of
March 31, 2018, Synlogichad cash, cash equivalents, and short-term investments of $125.8 million. In April 2018, the Company completed a registered direct offering generating $28.9 millionin net proceeds. Synlogicexpects its current cash, cash equivalents and marketable securities position will be sufficient to fund operations to mid-2020 based on its current business plan.
- Treatment of the first subject in a Phase 1/2a clinical trialevaluating
SYNB1618, indevelopment for the treatment of
phenylketonuria (PKU). This Phase 1/2a clinical trial is a single
(SAD) and multiple (MAD) dose-escalation, randomized, double-blind,
placebo-controlled study of orally administered SYNB1618 in healthy
adult volunteers and adult subjects with PKU. The study is designed to
evaluate safety, tolerability, kinetics, and pharmacodynamics as well
as exploratory end-points associated with the ability of SYNB1618 to
Synlogicexpects to report interim data from this trial in the second half of 2018 and the full data in 2019. More information about this study can be found at www.clinicaltrials.gov.
- Treatment of the first subject in a Phase 1b/2a clinical trial
evaluating SYNB1020, in development for the treatment of hyperammonemia.
This Phase1b/2a clinical trial is a randomized, double-blind,
placebo-controlled study designed to evaluate the safety and
tolerability of SYNB1020, as well as its ability to lower blood
ammonia levels, in patients with cirrhosis and elevated blood ammonia.
Synlogicexpects to report topline date from this trial at the end of 2018. Additional information about this study can be found at www.clinicaltrials.gov.
- Fast-Track designation granted by the
U.S. Food and Drug Administration( FDA) for SYNB1618 for the treatment of PKU. The FDA Fast Track program is designed to facilitate the development of important new drugs intended to treat a serious condition and to fill an unmet medical need. The designation enables early and frequent communication between the FDAand Synlogicensuring that questions and issues are resolved quickly, and often leading to earlier drug approval and access by patients.
- Presentation of preclinical data from Synlogic’s immuno-oncology
(IO) program at the annual meeting of the
American Association for Cancer Research(AACR). The data demonstrate that, in mouse models, Synthetic Biotic medicines stimulate an antitumor response and robustly reprogram the tumor microenvironment, potentially enabling the treatment of a variety of cancers.
First Quarter 2018 Financial Results
For the three months ended
Research and development expenses were
General and administrative expenses for the three months ended
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|
|March 31, 2018||March 31, 2017|
|Research and development||8,361||5,118|
|General and administrative||3,629||2,367|
|Total operating expenses||11,990||7,485|
|Loss from operations||(11,636)||(7,374)|
|Other income (expense), net||471||6|
|Net loss per share attributable to common shareholders - basic and diluted||$||(0.55)||$||-|
|Weighted-average common shares used in computing net loss per share attributable to common shareholders - basic and diluted||20,145,881||-|
|Net loss per unit attributable to common unit holders - basic and diluted||$||-||$||(4.49)|
|Weighted-average common units used in computing net loss per unit attributable to common unit holders - basic and diluted||-||
|Condensed Consolidated Balance Sheets Data|
|March 31, 2018||December 31, 2017|
|Cash, cash equivalents and short-term investments||$||125,803||$||87,025|
|Liabilities and Stockholders' Equity|
|Total stockholders' equity||128,767||85,038|
|Total liabilities and stockholders' equity||$||142,661||$||99,699|