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SEC Filings

10-Q
SERES THERAPEUTICS, INC. filed this Form 10-Q on 11/08/2018
Entire Document
 

PART II - OTHER INFORMATION

Item 1. Legal Proceedings.

Shareholder Litigation

On March 30, 2018, the U.S. District Court for the District of Massachusetts granted our motion to dismiss the putative class action lawsuit filed on September 28, 2016, entitled Mazurek v. Seres Therapeutics, Inc., et.al., alleging violations of Sections 10(b), 20(a) and Rule 10b-5 of the Securities Exchange Act of 1934, as amended, by making allegedly false and misleading statements and omissions about our clinical trials for our product candidate SER-109 in our public disclosures between June 25, 2015 and July 29, 2016. The plaintiff did not appeal the decision and the period for appeal has now lapsed.

Opposition Proceeding

On October 19, 2016, the European Patent Office granted European Patent No. 2 575 835 B1 to The University of Tokyo. On April 25, 2017, we filed a notice of opposition to this patent in the European Patent Office, requesting that it be revoked in its entirety for the reasons set forth in our opposition.  Although we believe this patent should be revoked in its entirety, the ultimate outcome of the opposition remains uncertain.

 

 

Item 1A. Risk Factors.

Investing in our common stock involves a high degree of risk. You should consider carefully the risks described below, together with the other information included or incorporated by reference in this Quarterly Report on Form 10-Q. If any of the following risks occur, our business, financial condition, results of operations and future growth prospects could be materially and adversely affected. In these circumstances, the market price of our common stock could decline.

Risks Related to Our Financial Position and Need for Additional Capital

We are a development-stage company and have incurred significant losses since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability. As a result, there is substantial doubt about our ability to continue as a going concern.

Since inception, we have incurred significant operating losses. Our net loss was $89.4 million for the year ended December 31, 2017, and $77.7 million for the nine months ended September 30, 2018. As of September 30, 2018, we had an accumulated deficit of $368.1 million. To date, we have financed our operations through the initial public offering of our common stock, private placements of our preferred stock, milestone payments under the licensing agreement with Nestec, Ltd., or NHS, and loan financing. We have devoted substantially all of our financial resources and efforts to developing our microbiome therapeutics platform, identifying potential product candidates and conducting pre-clinical studies and clinical trials. We have not completed development of any of our product candidates, which we call Ecobiotic microbiome therapeutics, or other drugs or biologics. We expect to continue to incur significant expenses and operating losses for the foreseeable future.  We anticipate that our expenses may increase substantially as we:

 

continue the clinical development of SER-109, our lead product candidate, in the Phase 3 clinical study;

 

continue the clinical development of SER-287 for the treatment of UC in adults and children and potential other studies of IBD;

 

initiate the clinical development of SER-401 in a Phase 1b clinical trial in patients with metastatic melanoma;

 

conduct research and continue pre-clinical development of additional Ecobiotic microbiome therapeutic candidates, including SER-155 and SER-301;

 

make strategic investments in manufacturing capabilities;

 

maintain and augment our intellectual property portfolio and opportunistically acquire complementary intellectual property;

 

potentially establish a sales and distribution infrastructure and scale-up manufacturing capabilities to commercialize any products for which we may obtain regulatory approval;

 

perform our obligations under the collaboration agreement with NHS;

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