Full Press Release Details
Selecta Biosciences Announces Third Quarter 2018
Financial Results and Provides Corporate Update
Watertown, Mass., Nov. 8, 2018 - Selecta Biosciences, Inc. (Nasdaq: SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by mitigating unwanted immune responses, today reported financial results for the third quarter ended September 30, 2018 and provided a corporate update.
"We believe that our lead program, SEL-212, has the potential to fulfill several unmet needs in chronic severe gout patients including sustained serum uric acid reduction, reduced painful flares and once monthly dosing. We have recently presented interim data from our Phase 2 trial at ACR showing sustained SUA control over a five-month combination period. Based on these data, we are planning the initiation of a six-month head-to-head superiority clinical trial against Krystexxa with interim data readouts expected in 2019 and full data presentation anticipated in first quarter of 2020," said Werner Cautreels, Ph.D., President and CEO of Selecta. "We believe our SVP technology has the potential to induce antigen specific tolerance allowing for the full benefit of biologics, including the possible re-dosing of AAV gene therapy programs. As Selecta enters the next stage of its growth, we look forward to the portfolio development strategy under the leadership of new CEO, Carsten Brunn, Ph.D."
Recent Highlights and Anticipated Upcoming Milestones
treatment of chronic severe gout. These interim data continue to show that SEL-212 is generally well-tolerated at clinically active doses following repeated administrations in the trial and the serum uric acid (SUA) control rates observed for patients who completed the 5-month treatment period support the 6-month dosing strategy the company plans to pursue in the head-to-head trial and Phase 3 clinical program.
Third Quarter 2018 Financial Results:
program for SEL-212. However, prior to beginning the Phase 3 clinical program, the company expects to conduct the planned head-to-head trial against Krystexxa. The company will require an additional equity offering or other external sources of capital to conduct the planned head-to-head trial against Krystexxa.
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 third quarter 2018 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 10124090.
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 mitigating unwanted immune responses. Selecta plans to combine its tolerogenic Synthetic Vaccine Particles (SVPTM) 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 therapeutic candidates. 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. A Phase 1 trial was initiated for a combination therapeutic candidate consisting of SVP-Rapamycin and LMB-100 (Selecta's SEL-403 product candidate) 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. We believe 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 2 clinical trial of SEL-212, the anticipated timing of the head-to-head trial comparing SEL-212 and Krystexxa and related data readouts, whether the head-to-head trial with Krystexxa will demonstrate superiority, the potential of SVP-Rapamycin to enable re-dosing of AAV gene therapy and the anticipated timing of preclinical toxicology studies and initiation of a clinical trial related thereto, whether the company's SVP technology has the potential to induce antigen specific tolerance and allow for the full benefit of biologics, the potential of SEL-212 to fulfill unmet needs in severe gout patients including sustained SUA reduction, reduced flares, and once monthly dosing, whether interim data related to the SEL-212 clinical program will be predictive of future data, the anticipated timing for advancing into Phase 3 (if at all), whether current evaluable SEL-212 patients will be predictive of future evaluable SEL-212 patients, whether patients receiving SEL-212 will be able to complete full therapy cycles over 6 months, whether SEL-212 will continue to be generally well-tolerated following repeat administrations, the company's ability to raise additional capital to fund the head-to-head trial against Krystexxa, the company's commercial plans, the ability of the company's SVP platform, including SVP-Rapamycin, to mitigate unwanted immunogenicity, unlock the full potential of biologic therapies, enable new therapies and improve the efficacy and safety of existing biologics, the potential of SEL-212 to treat severe gout patients and resolve their debilitating symptoms, the potential of SEL-403 to treat mesothelioma, the
potential treatment 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 company's plan to apply its SVP 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 potential of the SVP-Rapamycin platform generally, 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 SVP 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, 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)
| September 30, 2018 | December 31, 2017 | |||||||
| Assets | (Unaudited) | |||||||
| Current assets: | ||||||||
| Cash, cash equivalents, and restricted cash | $ | 50,485 | $ | 70,698 | ||||
| Short-term deposits and investments | - | 25,940 | ||||||
| Prepaid expenses and other current assets | 5,083 | 2,042 | ||||||
| Total current assets | 55,568 | 98,680 | ||||||
| Property and equipment, net | 2,109 | 2,091 | ||||||
| Restricted cash and other assets | 2,646 | 329 | ||||||
| Total assets | $ | 60,323 | $ | 101,100 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,252 | $ | 1,606 | ||||
| Accrued expenses | 10,218 | 8,580 | ||||||
| Loan payable, current portion | 21,299 | - | ||||||
| Deferred revenue, current portion | 1,863 | 787 | ||||||
| Total current liabilities | 34,632 | 10,973 | ||||||
| Non current liabilities: | ||||||||
| Deferred rent and lease incentive | 67 | 151 | ||||||
| Loan payable, net of current portion | - | 21,042 | ||||||
| Deferred revenue, net of current portion | 13,824 | 15,919 | ||||||
| Other long term liabilities | 1,800 | 1,201 | ||||||
| Total liabilities | 50,323 | 49,286 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively | - | - | ||||||
| Common stock, $0.0001 par value; 200,000,000 shares authorized; 22,426,493 and 22,343,254 shares issued and outstanding as of September 30, 2018 and December 31, 2017, respectively | 3 | 3 | ||||||
| Additional paid-in capital | 277,721 | 273,128 | ||||||
| Receivable from stock option exercises | (53 | ) | - | |||||
| Accumulated deficit | (263,154 | ) | (216,897 | ) | ||||
| Accumulated other comprehensive loss | (4,517 | ) | (4,420 | ) | ||||
| Total stockholders' equity | 10,000 | 51,814 | ||||||
| Total liabilities and stockholders' equity | $ | 60,323 | $ | 101,100 |
Selecta Biosciences, Inc. and Subsidiaries
Consolidated Statements of Operations and Comprehensive Loss
(Amounts in thousands, except share and per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2018 | 2017 | 2018 | 2017 | ||||||||||||
| (Unaudited) | |||||||||||||||
| Grant and collaboration revenue | $ | - | $ | 27 | $ | - | $ | 190 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 11,885 | 9,504 | 37,431 | 31,542 | |||||||||||
| General and administrative | 4,056 | 4,377 | 13,092 | 13,155 | |||||||||||
| Total operating expenses | 15,941 | 13,881 | 50,523 | 44,697 | |||||||||||
| Loss from operations | (15,941 | ) | (13,854 | ) | (50,523 | ) | (44,507 | ) | |||||||
| Investment income | 295 | 165 | 829 | 379 | |||||||||||
| Loss on extinguishment of debt | - | (673 | ) | - | (673 | ) | |||||||||
| Foreign currency transaction gain (loss), net | 26 | (30 | ) | 97 | (113 | ) | |||||||||
| Interest expense | (384 | ) | (268 | ) | (1,099 | ) | (847 | ) | |||||||
| Other income (expense), net | 3 | (16 | ) | 11 | (16 | ) | |||||||||
| Net loss | (16,001 | ) | (14,676 | ) | (50,685 | ) | (45,777 | ) | |||||||
| Other comprehensive loss: | |||||||||||||||
| Foreign currency translation adjustment | (42 | ) | (1 | ) | (113 | ) | 79 | ||||||||
| Unrealized gain on securities | 1 | 5 | 16 | 30 | |||||||||||
| Total comprehensive loss | $ | (16,042 | ) | $ | (14,672 | ) | $ | (50,782 | ) | $ | (45,668 | ) | |||
| Net loss per share: | |||||||||||||||
| Basic and diluted | $ | (0.71 | ) | $ | (0.66 | ) | $ | (2.27 | ) | $ | (2.31 | ) | |||
| Weighted average common shares outstanding: | |||||||||||||||
| Basic and diluted | 22,403,954 | 22,082,207 | 22,368,574 | 19,803,551 |
Contact Information:
Selecta Biosciences, Inc.
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