Full Press Release Details
Selecta Biosciences Announces Second Quarter 2017
Financial Results and Provides Corporate Update
Watertown, Mass., August 11, 2017 - 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 second quarter ended June 30, 2017 and provided a corporate update.
"The second quarter of 2017 was a time of significant accomplishment for the Selecta team as we advanced our pipeline of candidates that utilize our proprietary immune tolerance agent, SVP-Rapamycin," said Werner Cautreels, Ph.D., CEO and Chairman of Selecta. "We in-licensed a new clinical-stage oncology product candidate, presented additional gene therapy data and strengthened our balance sheet by raising $50 million in additional financing.
"Most importantly, we presented positive clinical data from our ongoing Phase 2 trial for our lead product candidate, SEL-212, indicating that we have identified a minimum effective dose that mitigates the formation of anti-drug antibodies (ADAs), allowing for a significant lowering and durable control of serum uric acid for gout patients over multiple monthly doses," Dr. Cautreels continued. "We believe such a treatment would enable the resolution of crystallized uric acid deposits, or tophi, that are increasingly being cited as sources of morbidity and mortality in chronic severe gout patients. The clinical data also suggest that the incidence of gout flares in patients treated with SEL-212 was reduced as compared to the control cohorts."
Recent Business Highlights and Activities
Second 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 second 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 10111055.
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 ) to 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 clinical oncology candidate, LMB-100, is in a Phase 1 program targeting pancreatic cancer and mesothelioma. Its two 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 is also being explored 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 severe gout patients and resolve their debilitating symptoms, whether the Phase 3 trial will be initiated in 2018, the company's ability to unlock the full potential of biologic therapies, 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, whether Selecta and NCI initiate a Phase 1b clinical trial of the LMB-100 and SVP-Rapamycin combination, the potential of the company's two gene therapy product candidates to enable repeat administration, the sufficiency of the company's cash, cash equivalents, investments, and restricted cash 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 May 11, 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)
| June 30, 2017 | December 31, 2016 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 82,630 | $ | 58,656 | ||||
| Short-term deposits and investments | 30,025 | 25,485 | ||||||
| Restricted cash | 74 | 78 | ||||||
| Accounts receivable | 1 | 215 | ||||||
| Prepaid expenses and other current assets | 1,848 | 2,382 | ||||||
| Total current assets | 114,578 | 86,816 | ||||||
| Property and equipment, net | 2,131 | 2,047 | ||||||
| Restricted cash and other deposits | 316 | 316 | ||||||
| Other assets | - | 122 | ||||||
| Total assets | $ | 117,025 | $ | 89,301 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,280 | $ | 3,882 | ||||
| Accrued expenses | 8,595 | 3,921 | ||||||
| Loans payable, current portion | 4,612 | 4,067 | ||||||
| Deferred revenue, current portion | 2,566 | 1,836 | ||||||
| Total current liabilities | 20,053 | 13,706 | ||||||
| Non current liabilities: | ||||||||
| Deferred rent and lease incentive | 189 | 222 | ||||||
| Loans payable, net of current portion | 5,732 | 7,977 | ||||||
| Deferred revenue, net of current portion | 11,619 | 12,439 | ||||||
| Other long term liabilities | 1,250 | - | ||||||
| Total liabilities | 38,843 | 34,344 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively. | - | - | ||||||
| Common stock, $0.0001 par value; 200,000,000 shares authorized; 22,056,147 and 18,438,742 shares issued and outstanding as of June 30, 2017 and December 31, 2016, respectively. | 1 | 1 | ||||||
| Additional paid-in capital | 265,297 | 211,125 | ||||||
| Receivable from stock option exercises | (26 | ) | (75 | ) | ||||
| Accumulated deficit | (182,677 | ) | (151,576 | ) | ||||
| Accumulated other comprehensive loss | (4,413 | ) | (4,518 | ) | ||||
| Total stockholders' equity | 78,182 | 54,957 | ||||||
| Total liabilities and stockholders' equity | $ | 117,025 | $ | 89,301 |
Selecta Biosciences, Inc. and Subsidiaries
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited, amounts in thousands, except share and per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Grant and collaboration revenue | $ | 26 | $ | 2,017 | $ | 163 | $ | 4,105 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 10,994 | 6,000 | 22,038 | 12,648 | ||||||||||||
| General and administrative | 4,903 | 2,418 | 8,778 | 4,799 | ||||||||||||
| Total operating expenses | 15,897 | 8,418 | 30,816 | 17,447 | ||||||||||||
| Loss from operations | (15,871 | ) | (6,401 | ) | (30,653 | ) | (13,342 | ) | ||||||||
| Investment income | 101 | 10 | 214 | 23 | ||||||||||||
| Foreign currency transaction gain (loss), net | 82 | (158 | ) | (83 | ) | (378 | ) | |||||||||
| Interest expense | (279 | ) | (310 | ) | (579 | ) | (620 | ) | ||||||||
| Other expense, net | - | (64 | ) | - | (82 | ) | ||||||||||
| Net loss | (15,967 | ) | (6,923 | ) | (31,101 | ) | (14,399 | ) | ||||||||
| Other comprehensive loss: | ||||||||||||||||
| Foreign currency translation adjustment | (43 | ) | 170 | 80 | 401 | |||||||||||
| Unrealized gain (loss) on securities | 10 | - | 25 | - | ||||||||||||
| Comprehensive loss | $ | (16,000 | ) | $ | (6,753 | ) | $ | (30,996 | ) | $ | (13,998 | ) | ||||
| Net loss | (15,967 | ) | (6,923 | ) | (31,101 | ) | (14,399 | ) | ||||||||
| Accretion of redeemable convertible preferred stock | - | (2,210 | ) | - | (4,566 | ) | ||||||||||
| Net loss attributable to common stockholders | $ | (15,967 | ) | $ | (9,133 | ) | $ | (31,101 | ) | $ | (18,965 | ) | ||||
| Net loss per share attributable to common stockholders | ||||||||||||||||
| Basic and diluted | $ | (0.85 | ) | $ | (2.75 | ) | $ | (1.67 | ) | $ | (6.90 | ) | ||||
| Weighted average common shares outstanding | ||||||||||||||||
| Basic and diluted | 18,814,570 | 3,322,546 | 18,645,339 | 2,749,105 |
Contact Information:
Selecta Biosciences, Inc.