Full Press Release Details
Selecta Biosciences Reports First Quarter 2019 Financial Results
and Provides Corporate Update
Watertown, Mass., May 9, 2019 - Selecta Biosciences, Inc. (Nasdaq: SELB), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform technology, ImmTOR, today reported financial results for the first quarter ended March 31, 2019 and provided a corporate update.
"We are excited to be enrolling patients in the COMPARE trial and look forward to the opportunity to differentiate SEL-212 compared to the current FDA-approved uricase therapy in adult patients with chronic refractory gout," said Carsten Brunn, Ph.D., President and CEO of Selecta. "As we continue to develop our ImmTOR platform for rare and serious diseases, we are pleased by the advancements in our gene therapy program, most recently with the presentation of new preclinical data at ASGCT highlighting how the co-administration of our technology with AAV-based vectors suppressed the immune response to the vector, potentially enabling re-dosing to provide sustained therapeutic efficacy over time."
Recent Highlights and Anticipated Upcoming Milestones
SEL-212 (ImmTOR+Pegadricase) for the Treatment of Chronic Refractory Gout:
ImmTOR + AAV Gene Therapy Program:
First Quarter 2019 Financial Results:
Selecta believes its available cash, cash equivalents and restricted cash will be sufficient to meet its operating requirements into the first quarter of 2020.
Conference Call and Webcast 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 first quarter 2019 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 10127202.
About Selecta Biosciences, Inc.
Selecta Biosciences, Inc. is a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance technology (ImmTOR) platform. Selecta plans to combine ImmTOR with a range of biologic therapies for rare and serious diseases that require new treatment options due to high immunogenicity. The company's current proprietary pipeline includes ImmTOR-powered therapeutic enzyme and gene therapy product candidates. SEL-212, the company's lead product candidate, is being developed to treat chronic refractory gout patients and resolve their debilitating symptoms, including flares and gouty arthritis. Selecta's proprietary gene therapy product candidates are in preclinical development for certain rare inborn errors of metabolism and incorporate ImmTOR with the goal of addressing barriers to repeat administration. Selecta is based in Watertown, Massachusetts. For more information, please visit http://selectabio.com.
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 clinical development of SEL-212, expectations surrounding the enrollment and design of the Phase 2 head-to-head (COMPARE) clinical trial comparing SEL-212 and Krystexxa, timing of related data readouts and the ability of the COMPARE results to inform the planned Phase 3 clinical trial of SEL-212, the anticipated timing of the planned Phase 3 clinical trial, whether the head-to-head trial with Krystexxa will demonstrate superiority, the potential of ImmTOR to enable re-dosing of AAV gene therapy and the anticipated timing of preclinical toxicology studies in collaboration with CureCN and initiation of a clinical trial related thereto, the potential of SEL-212 to fulfill unmet needs in chronic refractory gout patients including sustained sUA reduction, reduced flares, and once monthly dosing, the company's commercial plans, the ability of the company's ImmTOR platform, including SEL-212, to unlock the full potential of biologic therapies, the potential of SEL-212 to treat chronic refractory gout patients and resolve their debilitating symptoms, the potential treatment applications for product candidates utilizing the ImmTOR platform in areas such as enzyme therapy and gene therapy, the company's plan to apply its ImmTOR technology platform to a range of biologics for rare and serious diseases, the potential of the company's two gene therapy product candidates to enable repeat administration, the Company's ability to re-dose patients and the potential of ImmTOR to allow for re-dosing, the potential of the ImmTOR technology platform generally and the company's ability to grow its strategic partnerships, the sufficiency of the company's cash, cash equivalents and short-term investments, 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 availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a particular clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, the unproven approach of the company's ImmTOR technology, potential delays in enrollment of patients, 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, the company's recurring losses from operations and negative cash flows from operations raise substantial doubt regarding its ability to continue as a going concern, substantial fluctuation in the price of its common stock, and other important factors discussed in the "Risk Factors" section of the company's Annual Report on Form 10-Q for the quarter ended March 31, 2019, and in other filings that the company makes with the Securities and Exchange Commission. 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
(Amounts in thousands, except share data and par value)
| March 31, 2019 | December 31, 2018 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash, cash equivalents, and restricted cash | $ | 32,452 | $ | 37,403 | ||||
| Short-term deposits and investments | 16,244 | - | ||||||
| Prepaid expenses and other current assets | 10,832 | 4,673 | ||||||
| Total current assets | 59,528 | 42,076 | ||||||
| Property and equipment, net | 1,799 | 2,127 | ||||||
| Right of Use Asset, net | 1,155 | - | ||||||
| Restricted cash and other assets | - | 279 | ||||||
| Total assets | $ | 62,482 | $ | 44,482 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 693 | $ | 1,100 | ||||
| Accrued expenses | 8,500 | 11,700 | ||||||
| Loan payable, current portion | 21,466 | 21,385 | ||||||
| Lease Liability, current portion | 1,428 | - | ||||||
| Deferred revenue, current portion | 959 | 959 | ||||||
| Total current liabilities | 33,046 | 35,144 | ||||||
| Non current liabilities: | ||||||||
| Deferred rent and lease incentive | - | 34 | ||||||
| Deferred revenue, net of current portion | 13,816 | 13,818 | ||||||
| Other long term liabilities | 801 | 904 | ||||||
| Total liabilities | 47,663 | 49,900 | ||||||
| Stockholders' equity (deficit): | ||||||||
| Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively | - | - | ||||||
| Common stock, $0.0001 par value; 200,000,000 shares authorized; 44,788,025 and 22,471,776 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively | 5 | 3 | ||||||
| Additional paid-in capital | 311,824 | 279,539 | ||||||
| Accumulated deficit | (292,477 | ) | (280,403 | ) | ||||
| Accumulated other comprehensive loss | (4,533 | ) | (4,557 | ) | ||||
| Total stockholders' equity (deficit) | 14,819 | (5,418 | ) | |||||
| Total liabilities and stockholders' equity | $ | 62,482 | $ | 44,482 |
Selecta Biosciences, Inc. and Subsidiaries
Consolidated Statements of Operations and Comprehensive Loss
(Amounts in thousands, except share and per share data)
| Three Months Ended March 31, | |||||||
| 2019 | 2018 | ||||||
| (Unaudited) | |||||||
| Grant and collaboration revenue | $ | 10 | $ | - | |||
| Operating expenses: | |||||||
| Research and development | 7,353 | 11,139 | |||||
| General and administrative | 4,513 | 4,674 | |||||
| Total operating expenses | 11,866 | 15,813 | |||||
| Loss from operations | (11,856 | ) | (15,813 | ) | |||
| Investment income | 277 | 288 | |||||
| Foreign currency transaction (loss), net | (30 | ) | (13 | ) | |||
| Interest expense | (396 | ) | (350 | ) | |||
| Other (expense), net | (69 | ) | - | ||||
| Net loss | (12,074 | ) | (15,888 | ) | |||
| Other comprehensive loss: | |||||||
| Foreign currency translation adjustment | 22 | 19 | |||||
| Unrealized gain on securities | 2 | 3 | |||||
| Total comprehensive loss | $ | (12,050 | ) | $ | (15,866 | ) | |
| Net loss per share: | |||||||
| Basic and diluted | $ | (0.31 | ) | $ | (0.71 | ) | |
| Weighted average common shares outstanding: | |||||||
| Basic and diluted | 38,447,319 | 22,345,523 |
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