WATERTOWN, Mass., May 13, 2021 (GLOBE NEWSWIRE) — Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR™ platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, today reported financial results for the first quarter ended March 31, 2021 and provided a business update.
“We are very pleased about the continued progress across all aspects of the company,” said Carsten Brunn, Ph.D., president and chief executive officer of Selecta. “We regained exclusive rights to our MMA program and now have two proprietary gene therapy programs to rapidly follow our ongoing empty capsid study. Additionally, we continue to progress our enzyme program, with an expected IND filing by the end of 2021 in IgA nephropathy, and topline data from the Phase 3 DISSOLVE program for SEL-212 anticipated in the second half of 2022.”
Recent Highlights and Anticipated Upcoming Milestones:
Enzyme Therapies:
Gene Therapies:
Restoring Self-Tolerance in Autoimmune Diseases:
Corporate Updates:
First Quarter 2021 Financial Results:
Cash Position: Selecta had $149.2 million in cash, cash equivalents, marketable securities, and restricted cash as of March 31, 2021, which compares to cash, cash equivalents, and restricted cash of $140.1 million as of December 31, 2020. Selecta believes its available cash, cash equivalents, marketable securities, and restricted cash will be sufficient to meet its operating requirements into the second quarter of 2023.
Revenue: Revenue recognition for the first quarter of 2021 was $11.1 million, compared to no revenue recognition for the same period in 2020. Revenue was recognized under the license agreement with Sobi which began in July 2020 resulting from the shipment of clinical supply and the reimbursement of costs incurred for the Phase 3 DISSOLVE clinical program.
Research and Development Expenses: Research and development expenses for the first quarter 2021 were $13.0 million, which compares with $14.7 million for the same period in 2020. During the quarter ended March 31, 2021, there was a reduction in expenses for the SEL-212 clinical program and for the AskBio Collaboration, offset by an increase of expense for discovery and preclinical programs.
General and Administrative Expenses: General and administrative expenses for the first quarter 2021 were $5.2 million, which compares with $4.1 million for the same period in 2020. The quarterly increase in expense was the result of expenses for consulting and professional fees and salaries offset by reduced travel expenses.
Net Loss: For the first quarter 2021, Selecta reported a net loss of $24.6 million, or $0.22 per share, compared to a net loss of $19.6 million, or $0.21 per share for the same period in 2020.
Conference Call and Webcast Reminder:
Selecta management will host a conference call at 8:30 AM ET today to provide a corporate update and review the company’s first quarter 2021 financial results. Individuals may 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 10147801. Investors and the public can access the live and archived webcast of this call and a copy of the presentation via the Investors & Media section of the company’s website, www.selectabio.com.
About Selecta Biosciences, Inc.
Selecta Biosciences Inc. (NASDAQ: SELB) is a clinical stage biotechnology company leveraging its ImmTOR™ platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses. With a proven ability to induce tolerance to highly immunogenic proteins, ImmTOR has the potential to amplify the efficacy of biologic therapies, including redosing of life-saving gene therapies, as well as restore the body’s natural self-tolerance in autoimmune diseases. Selecta has several proprietary and partnered programs in its pipeline focused on enzyme therapies, gene therapies, and autoimmune diseases. Selecta Biosciences is headquartered in the Greater Boston area. For more information, please visit www.selectabio.com.
Selecta 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 unique proprietary technology platform of the Company, and the unique proprietary platform of its partners, the potential of ImmTOR to enable re-dosing of AAV gene therapy and to mitigate immunogenicity, the anticipated timing or the outcome of ongoing and planned clinical trials, studies and data readouts, the Company’s ability to conduct those clinical trials and studies, the timing or making of any regulatory filings, the potential treatment applications of product candidates utilizing the ImmTOR platform in areas such as gene therapy, gout and autoimmune disease, the ability of the Company and its partners where applicable to develop gene therapy products using ImmTOR, the novelty of treatment paradigms that the Company is able to develop, whether the observations made in non-human primate study subjects will translate to studies performed with human beings, the potential of any therapies developed by the Company to fulfill unmet medical needs, the Company’s plan to apply its ImmTOR technology platform to a range of biologics for rare and orphan genetic diseases, the potential of the Company’s intellectual property to enable repeat administration in gene therapy product candidates and products, the ability to re-dose patients and the potential of ImmTOR to allow for re-dosing, the potential to safely re-dose AAV, the ability to restore transgene expression, the potential of the ImmTOR technology platform generally and the Company’s ability to grow its strategic partnerships, 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 proof of concept trials, including the 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 ability to predict results of studies performed on human beings based on results of studies performed on non-human primates, 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 most recent Quarterly Report on Form 10-Q to be filed after this release, 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 intention 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, 2021 | December 31, 2020 | |||||||
(Unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 125,407 | $ | 138,685 | ||||
Marketable securities | 22,405 | — | ||||||
Accounts receivable | 8,342 | 7,224 | ||||||
Prepaid expenses and other current assets | 6,971 | 5,434 | ||||||
Total current assets | 163,125 | 151,343 | ||||||
Property and equipment, net | 1,301 | 1,395 | ||||||
Right-of-use asset, net | 10,676 | 10,948 | ||||||
Long-term restricted cash | 1,379 | 1,379 | ||||||
Other assets | 265 | 370 | ||||||
Total assets | $ | 176,746 | $ | 165,435 | ||||
Liabilities and stockholders’ (deficit) equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 594 | $ | 443 | ||||
Accrued expenses | 6,847 | 8,146 | ||||||
Loan payable | 460 | — | ||||||
Lease liability | 942 | 908 | ||||||
Deferred revenue | 75,764 | 72,050 | ||||||
Total current liabilities | 84,607 | 81,547 | ||||||
Non-current liabilities: | ||||||||
Loan payable, net of current portion | 24,551 | 24,793 | ||||||
Lease liability | 9,403 | 9,647 | ||||||
Deferred revenue | 32,301 | 38,746 | ||||||
Warrant liabilities | 45,455 | 28,708 | ||||||
Total liabilities | 196,317 | 183,441 | ||||||
Stockholders’ (deficit) equity: | ||||||||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding at March 31, 2021 and December 31, 2020 | — | — | ||||||
Common stock, $0.0001 par value; 200,000,000 shares authorized; 112,977,004 and 108,071,249 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively | 11 | 11 | ||||||
Additional paid-in capital | 414,214 | 391,175 | ||||||
Accumulated deficit | (429,226 | ) | (404,629 | ) | ||||
Accumulated other comprehensive loss | (4,570 | ) | (4,563 | ) | ||||
Total stockholders’ (deficit) equity | (19,571 | ) | (18,006 | ) | ||||
Total liabilities and stockholders’ (deficit) equity | $ | 176,746 | $ | 165,435 | ||||
Selecta Biosciences, Inc. and Subsidiaries
Consolidated Statements of Operations and Comprehensive Loss
(Amounts in thousands, except share data and per share data)
Three Months Ended March 31, | |||||||
2021 | 2020 | ||||||
(Unaudited) | |||||||
Grant and collaboration revenue | $ | 11,050 | $ | — | |||
Operating expenses: | |||||||
Research and development | 13,004 | 14,724 | |||||
General and administrative | 5,204 | 4,098 | |||||
Total operating expenses | 18,208 | 18,822 | |||||
Loss from operations | (7,158 | ) | (18,822 | ) | |||
Investment income | 12 | 240 | |||||
Foreign currency transaction gain, net | 7 | 82 | |||||
Interest expense | (711 | ) | (273 | ) | |||
Change in fair value of warrant liabilities | (16,747 | ) | (846 | ) | |||
Other income (expense), net | — | (1 | ) | ||||
Net loss | (24,597 | ) | (19,620 | ) | |||
Other comprehensive loss: | |||||||
Foreign currency translation adjustment | (6 | ) | (60 | ) | |||
Unrealized (losses) on marketable securities | (1 | ) | — | ||||
Total comprehensive loss | $ | (24,604 | ) | $ | (19,680 | ) | |
Net loss per share: | |||||||
Basic and diluted | $ | (0.22 | ) | $ | (0.21 | ) | |
Weighted average common shares outstanding: | |||||||
Basic and diluted | 110,742,150 | 94,723,513 | |||||
For Investors:
Bruce Mackle
LifeSci Advisors, LLC
+1-929-469-3859
bmackle@lifesciadvisors.com
For Media:
Meredith Sosulski, Ph.D.
LifeSci Communications, LLC
+1-929-469-3851
msosulski@lifescicomms.com
This year, more people are choosing mindful, alcohol-free holidays.Forest Row, England--(Newsfile Corp. - November 27,…
CHICAGO, Nov. 27, 2024 /PRNewswire/ -- Powerful Medical became the first company to win both…
Among Top 5 Fastest-Growing Healthcare Technology Companies in North America MIAMI, TORONTO and SYDNEY, Nov.…
LONDON, Nov. 27, 2024 /PRNewswire/ -- Oclean, leader in innovative oral care solutions, is thrilled…
The dental practice management market is driven by the increasing prevalence of oral health issues,…
AI-powered chest X-ray and mammography analysis solutions to be deployed across one of Mexico's largest…