SELECTA BIOSCIENCES,INC. (NASDAQ:SELB) Files An 8-K Results of Operations and Financial ConditionItem 2.02. Results of Operations and Financial Condition.
On November 7, 2017, Selecta Biosciences, Inc. (the “Company”) announced its financial results for the quarter ended September 30, 2017. The full text of the press release issued in connection with the announcement is furnished as Exhibit99.1 to this Current Report on Form8-K.
The information contained in Item 2.02 of this Form8-K (including Exhibit99.1 attached hereto) shall not be deemed “filed” for purposes of Section18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly provided by specific reference in such a filing.
Item 7.01. Regulation FD Disclosure.
In connection with the issuance of the press release, the Company is holding a public conference call and webcast on November 7, 2017, at 8:30 a.m. ET, during which the Company will provide the investor presentation attached as Exhibit 99.2 to this Current Report on Form 8-K. The investor presentation will include additional data from the Company’s ongoing Phase 2 company-sponsored trial, which is assessing single ascending dose safety, pharmacokinetic and pharmacodynamics of SEL-212 in patients with elevated uric acid levels. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.2.
The information furnished under this Item 7.01 (including Exhibit 99.2 attached hereto) shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act, except as expressly provided by specific reference in such a filing.
Forward-Looking Statements Disclaimer
This Current Report on Form 8-K (the “Current Report”) contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our ability to determine appropriate SEL-212 dose regimens for our Phase 3 program and our expectations surrounding the initiation of our Phase 3 program. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including their uncertain outcomes; the unproven approach of our SVP technology; undesirable side effects of our product candidates; our reliance on third parties to manufacture our product candidates and to conduct our clinical trials; our inability to maintain our existing or future collaborations or licenses; our inability to protect our proprietary technology and intellectual property; potential delays in regulatory approvals; and availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on August 11, 2017, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this Current Report. Any such forward-looking statements represent management’s estimates as of the date of this Current Report. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this Current Report.
Item 9.01. Financial Statements and Exhibits.
(d)Exhibits
SELECTA BIOSCIENCES INC ExhibitEX-99.1 2 exhibit991_earningsrelease.htm EXHIBIT 99.1 Exhibit Exhibit 99.1 Selecta Biosciences Announces Third Quarter 2017 Financial Results and Provides Corporate Update•Patient Data From Ongoing Phase 2 Trial to be Presented Today at the American College of Rheumatology (ACR) 2017 Annual Meeting•Preparations for Phase 3 Program Underway•Received $7.5 Million From Spark Therapeutics •Strengthened Senior Management Team•Company to Host Conference Call Today at 8:30 a.m. ET Watertown,…To view the full exhibit click here
About SELECTA BIOSCIENCES,INC. (NASDAQ:SELB)
Selecta Biosciences, Inc. is a clinical-stage biopharmaceutical company. The Company using its synthetic vaccine particle (SVP) technology to discover and develop targeted therapies that are designed to modulate the immune system to treat rare and serious diseases. The Company is engaged in the research and development of nanoparticle immunomodulatory drugs for the treatment and prevention of human diseases. The Company’s product candidates are in development. The Company’s SVP technology encapsulates an immunomodulator in biodegradable nanoparticles to induce antigen-specific immune tolerance to mitigate the formation of anti-drug antibodies (ADAs) in response to life-sustaining biologic drugs. The Company’s technology allows for the design of SVP therapies that can stimulate immune responses against a range of relevant antigens. Its initial immune-stimulating product candidate is a synthetic vaccine against nicotine for the market of smoking cessation and relapse prevention.
