Full Press Release Details
Selecta Biosciences Announces Second Quarter 2018
Financial Results and Provides Corporate Update
Watertown, Mass., Aug. 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 second quarter ended June 30, 2018 and provided a corporate update.
"The continued improvement in clinical activity observed in the expanded patient data set recently presented at the EULAR conference in June further demonstrates the benefit SEL-212 may provide to chronic severe gout patients and its potential ability to change the current treatment paradigm in these patients with high medical need," said Werner Cautreels, Ph.D., President and CEO of Selecta. "We look forward to presenting data from patients receiving five monthly doses of SEL-212 at the upcoming ACR meeting in October and expect to initiate the Phase 3 program for SEL-212 in the fourth quarter of this year. In addition, we plan to conduct a head-to-head clinical trial against Krystexxa in parallel with our Phase 3 program."
Recent Highlights and Anticipated Upcoming Milestones
patients had serum uric acid control below 6 mg/dl at week 16. 33% of the patient population represented by our EULAR data, and only 27% of all current patients in the SEL-212 Phase 2 trial, experienced gout flares during the first month after treatment with continued reduction of gout flare rates over months two to five. This reduced rate of gout flares appears to be substantially lower than the incidence of gout flares reported in clinical trials involving the current FDA-approved uricase and other uric acid lowering therapies.
Second Quarter 2018 Financial Results:
Conference Call Reminder
Selecta management will host a conference call at 8:30 a.m. ET today to 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 10122287.
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) 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 2 clinical trial of SEL-212, the anticipated timing for reporting further data from the Phase 2 trial, conducting an End-of-Phase 2 meeting (if at all) and advancing into Phase 3 (if at all), the potential for patient data from the SEL-212 Phase 2 trial to continue to show improved clinical activity, 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 design and potential significance of a head-to-head trial of SEL-212 and Krystexxa and the company's expectations surrounding the timing of initiating and reporting data from the head-to-head trial (if at all), statements regarding the progress and enrollment of the Phase 1 trial for SEL-403 in mesothelioma, the potential Phase 1 study of SEL-403 in patients with pancreatic cancer in cooperation with NCI, and the potential of SEL-403 to treat other cancers, statements regarding the company's proprietary product candidate for the treatment of methylmalonic acidemia, statements regarding the company's ability to unlock the full potential of biologic therapies by mitigating unwanted immune responses, the ability of the company's SVP platform, including SVP-Rapamycin, to enable new therapies or to improve the efficacy or safety of existing biologics by mitigating immune response, the potential of SEL-212 to treat severe gout patients, resolve their debilitating symptoms, and to change the chronic severe gout treatment paradigm, 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 to unlock the full potential of gene therapy as a treatment modality, the sufficiency of the company's capital resources to fund its operating expenses and capital expenditure requirements through the third quarter of 2019, 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 or licenses, 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, 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 9, 2018, 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, 2018 | December 31, 2017 | |||||||
| Assets | (Unaudited) | |||||||
| Current assets: | ||||||||
| Cash, cash equivalents, and restricted cash | $ | 60,237 | $ | 70,698 | ||||
| Short-term deposits and investments | 5,991 | 25,940 | ||||||
| Prepaid expenses and other current assets | 2,607 | 2,042 | ||||||
| Total current assets | 68,835 | 98,680 | ||||||
| Property and equipment, net | 2,137 | 2,091 | ||||||
| Restricted cash and other assets | 2,465 | 329 | ||||||
| Total assets | $ | 73,437 | $ | 101,100 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,789 | $ | 1,606 | ||||
| Accrued expenses | 10,184 | 8,580 | ||||||
| Deferred revenue, current portion | 1,918 | 787 | ||||||
| Total current liabilities | 13,891 | 10,973 | ||||||
| Non current liabilities: | ||||||||
| Deferred rent and lease incentive | 98 | 151 | ||||||
| Loan payable | 21,212 | 21,042 | ||||||
| Deferred revenue, net of current portion | 12,870 | 15,919 | ||||||
| Other long term liabilities | 1,104 | 1,201 | ||||||
| Total liabilities | 49,175 | 49,286 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively | - | - | ||||||
| Common stock, $0.0001 par value; 200,000,000 shares authorized; 22,396,183 and 22,343,254 shares issued and outstanding as of June 30, 2018 and December 31, 2017, respectively | 3 | 3 | ||||||
| Additional paid-in capital | 275,888 | 273,128 | ||||||
| Accumulated deficit | (247,153 | ) | (216,897 | ) | ||||
| Accumulated other comprehensive loss | (4,476 | ) | (4,420 | ) | ||||
| Total stockholders' equity | 24,262 | 51,814 | ||||||
| Total liabilities and stockholders' equity | $ | 73,437 | $ | 101,100 |
Selecta Biosciences, Inc. and Subsidiaries
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2018 | 2017 | 2018 | 2017 | ||||||||||||
| (Unaudited) | |||||||||||||||
| Grant and collaboration revenue | $ | - | $ | 26 | $ | - | $ | 163 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 14,407 | 10,994 | 25,546 | 22,038 | |||||||||||
| General and administrative | 4,362 | 4,903 | 9,036 | 8,778 | |||||||||||
| Total operating expenses | 18,769 | 15,897 | 34,582 | 30,816 | |||||||||||
| Loss from operations | (18,769 | ) | (15,871 | ) | (34,582 | ) | (30,653 | ) | |||||||
| Investment income | 246 | 101 | 534 | 214 | |||||||||||
| Foreign currency transaction gain (loss), net | 84 | 82 | 71 | (83 | ) | ||||||||||
| Interest expense | (365 | ) | (279 | ) | (715 | ) | (579 | ) | |||||||
| Other income (expense), net | 8 | - | 8 | - | |||||||||||
| Net loss | (18,796 | ) | (15,967 | ) | (34,684 | ) | (31,101 | ) | |||||||
| Other comprehensive loss: | |||||||||||||||
| Foreign currency translation adjustment | (90 | ) | (43 | ) | (71 | ) | 80 | ||||||||
| Unrealized gain on securities | 12 | 10 | 15 | 25 | |||||||||||
| Total comprehensive loss | $ | (18,874 | ) | $ | (16,000 | ) | $ | (34,740 | ) | $ | (30,996 | ) | |||
| Net loss per share: | |||||||||||||||
| Basic and diluted | $ | (0.84 | ) | $ | (0.85 | ) | $ | (1.55 | ) | $ | (1.67 | ) | |||
| Weighted average common shares outstanding: | |||||||||||||||
| Basic and diluted | 22,355,603 | 18,814,570 | 22,350,591 | 18,645,339 |
Contact Information:
Selecta Biosciences, Inc.
Stern Investor Relations, Inc.