Full Press Release Details
Selecta Biosciences Announces Fourth Quarter and Year End 2017
Financial Results and Provides Corporate Update
Watertown, Mass., March 15, 2018 - Selecta Biosciences, Inc. (NASDAQ: SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by avoiding unwanted immune responses, today reported financial results for the fourth quarter and full year ended December 31, 2017 and provided a corporate update.
"Several important achievements have been made over the course of the past several months, and we are excited to be in a strong position to execute on our 2018 milestones," said Werner Cautreels, Ph.D., President and CEO of Selecta. "We remain on track with the development of SEL-212 for chronic severe gout, with higher dose data from our Phase 2 trial to be presented in April and plans underway to initiate our Phase 3 program in 2018. We also recently announced that our next clinical candidate, SEL-403, has entered the clinic for the treatment of patients with mesothelioma at the National Cancer Institute. This also provides us with the opportunity to demonstrate for a second time the translation of our technology in the clinic. When coupled with the Board and management enhancements that were made over the course of the past year, we believe we have positioned Selecta for a momentous year in 2018."
Recent Business Highlights and Activities
be receiving SVP-Rapamycin doses ranging from 0.1mg/kg-0.15mg/kg in combination with 0.2mg/kg of pegsiticase. The company expects to present data from these patients at a medical meeting in Q3 2018.
Fourth Quarter Financial Results:
Conference Call Reminder
Selecta management will host a conference call at 8:30 a.m. ET today to provide a corporate update and review the company's fourth quarter financial results. Investors and the public can access a live and archived webcast of this call via the Investors & Media section of the company's website, http://selectabio.com. Individuals may also participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10116990.
About Selecta Biosciences, Inc.
Selecta Biosciences, Inc. is a clinical-stage biopharmaceutical company that is focused on unlocking the full potential of biologic therapies by avoiding unwanted immune responses. Selecta plans to combine its tolerogenic Synthetic Vaccine Particles (SVP ) with a range of biologics for rare and serious diseases that require new treatment options. The Company's current proprietary pipeline includes SVP-enabled enzyme, oncology and gene therapies. SEL-212, the company's lead candidate in Phase 2, is being developed to treat severe gout patients and resolve their debilitating symptoms, including flares and gouty arthritis. Selecta's SEL-403 product candidate, a combination therapy consisting of SVP-Rapamycin and LMB-100, recently entered a Phase 1 trial in 2018 for the treatment of patients with malignant pleural or peritoneal mesothelioma. Selecta's proprietary gene therapy product candidates are being developed for rare inborn errors of metabolism and have the potential to enable repeat administration. The use of SVP also holds potential in the development of vaccines and treatments for allergies and autoimmune diseases.
Selecta is based in Watertown, Massachusetts. For more information, please visit http://selectabio.com and follow @SelectaBio on Twitter.
Forward-Looking Statements
Any statements in this press release about the future expectations, plans and prospects of Selecta Biosciences, Inc. ("the company"), including without limitation, statements regarding the progress of the Phase 1/2 clinical program of SEL-212, the potential of SEL-212 to treat chronic severe gout patients and resolve their debilitating symptoms, the company's plans to present data concerning higher dose cohorts in the Phase 2 of SEL-212 in April 2018, whether the Phase 3 trial for SEL-212 will be initiated in 2018 or at all, the company's ability to execute on its 2018 milestones, the company's plans to dose patients with five monthly combination doses of SEL-212, the company's plans to present data on cohorts receiving five combination doses of SEL-212 in Q3 2018, whether the company will meet with the FDA for an End of Phase 2 meeting in mid-2018 or at all, the company's ability to define its design for the Phase 3 program with the FDA at its End of Phase 2 meeting or at all, statements regarding the progress of the Phase 1 trial for SEL-403, the company's ability to locate and enroll a sufficient number of eligible patients to participate in in the Phase I trial for SEL-403, the potential of the trial for SEL-403 to demonstrate the translation of the company's SVP technology in the clinic, statements regarding the sufficiency of our capital resources to fund our operating expenses and capital expenditure requirements into mid-2019, the company's ability to unlock the full potential of biologic therapies, the company's plan to apply its SVP platform to a range of biologics for rare and serious diseases, the potential applications for products utilizing the SVP platform in areas such as enzyme therapy, gene therapy, oncology therapy, vaccines and treatments for allergies and autoimmune diseases, the potential of the company's two gene therapy product candidates to enable repeat administration and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "hypothesize," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, 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 the company's SVP technology, undesirable side effects of the company's product candidates, its reliance on third parties to manufacture its product candidates and to conduct its clinical trials, the company's inability to maintain its existing or future collaborations, licenses or contractual relationships, its inability to protect its proprietary technology and intellectual property, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, substantial fluctuation in the price of its common stock, a significant portion of the company's total outstanding shares have recently become eligible to be sold into the market, and other important factors discussed in the "Risk Factors" section of the company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on November 7, 2017, and in other filings that the company makes with the SEC. In addition, any forward-looking statements included in this press release represent the company's views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The company specifically disclaims any obligation to update any forward-looking statements included in this press release.
Selecta Biosciences, Inc. and Subsidiaries
Consolidated Balance Sheets
(In thousands, except for shares and par value)
| December 31, 2017 | December 31, 2016 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 70,622 | $ | 58,656 | ||||
| Short-term deposits and investments | 25,940 | 25,485 | ||||||
| Restricted cash | 76 | 78 | ||||||
| Accounts receivable | 63 | 215 | ||||||
| Prepaid expenses and other current assets | 1,979 | 2,382 | ||||||
| Total current assets | 98,680 | 86,816 | ||||||
| Property and equipment, net | 2,091 | 2,047 | ||||||
| Restricted cash and other deposits | 329 | 316 | ||||||
| Other assets | - | 122 | ||||||
| Total assets | $ | 101,100 | $ | 89,301 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,606 | $ | 3,882 | ||||
| Accrued expenses | 8,580 | 3,921 | ||||||
| Loans payable, current portion | - | 4,067 | ||||||
| Deferred revenue, current portion | 787 | 1,836 | ||||||
| Total current liabilities | 10,973 | 13,706 | ||||||
| Non current liabilities: | ||||||||
| Deferred rent and lease incentive | 151 | 222 | ||||||
| Loans payable, net of current portion | 21,042 | 7,977 | ||||||
| Deferred revenue, net of current portion | 15,919 | 12,439 | ||||||
| Other long term liabilities | 1,201 | - | ||||||
| Total liabilities | 49,286 | 34,344 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding at December 31, 2017 and December 31, 2016, respectively | - | - | ||||||
| Common stock, $0.0001 par value; 200,000,000 shares authorized; 22,343,254 and 18,438,742 shares issued and outstanding as of December 31, 2017 and December 31, 2016, respectively | 3 | 1 | ||||||
| Additional paid-in capital | 273,128 | 211,125 | ||||||
| Receivable from stock option exercises | - | (75 | ) | |||||
| Accumulated deficit | (216,897 | ) | (151,576 | ) | ||||
| Accumulated other comprehensive loss | (4,420 | ) | (4,518 | ) | ||||
| Total stockholders' equity | 51,814 | 54,957 | ||||||
| Total liabilities and stockholders' equity | $ | 101,100 | $ | 89,301 |
Selecta Biosciences, Inc. and Subsidiaries
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
| Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
| 2017 | 2016 | 2017 | 2016 | ||||||||||||
| Grant and collaboration revenue | $ | 17 | $ | 2,930 | $ | 207 | $ | 8,083 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 13,623 | 11,033 | 45,165 | 29,702 | |||||||||||
| General and administrative | 5,671 | 5,757 | 18,826 | 13,051 | |||||||||||
| Total operating expenses | 19,294 | 16,790 | 63,991 | 42,753 | |||||||||||
| Loss from operations | (19,277 | ) | (13,860 | ) | (63,784 | ) | (34,670 | ) | |||||||
| Investment income | 238 | 113 | 617 | 234 | |||||||||||
| Loss on extinguishment of debt | - | - | (673 | ) | - | ||||||||||
| Foreign currency transaction gain (loss), net | (10 | ) | (96 | ) | (123 | ) | (525 | ) | |||||||
| Interest expense | (359 | ) | (322 | ) | (1,206 | ) | (1,253 | ) | |||||||
| Other income (expense), net | (136 | ) | 82 | (152 | ) | 4 | |||||||||
| Net loss | (19,544 | ) | (14,083 | ) | (65,321 | ) | (36,210 | ) | |||||||
| Other comprehensive loss: | |||||||||||||||
| Foreign currency translation adjustment | (1 | ) | 88 | 78 | 504 | ||||||||||
| Unrealized gain (loss) on securities | (10 | ) | (52 | ) | 20 | (36 | ) | ||||||||
| Total comprehensive loss | $ | (19,555 | ) | $ | (14,047 | ) | $ | (65,223 | ) | $ | (35,742 | ) | |||
| Net loss | $ | (19,544 | ) | $ | (14,083 | ) | $ | (65,321 | ) | $ | (36,210 | ) | |||
| Accretion of redeemable convertible preferred stock | - | - | - | (4,566 | ) | ||||||||||
| Net loss attributable to common stockholders | $ | (19,544 | ) | $ | (14,083 | ) | $ | (65,321 | ) | $ | (40,776 | ) | |||
| Net loss per share attributable to common stockholders: | |||||||||||||||
| Basic and diluted | $ | (0.88 | ) | $ | (0.77 | ) | $ | (3.20 | ) | $ | (3.89 | ) | |||
| Weighted average common shares outstanding: | |||||||||||||||
| Basic and diluted | 22,269,282 | 18,265,771 | 20,425,050 | 10,493,939 |
Contact Information:
Selecta Biosciences, Inc.
Selecta Biosciences, Inc.