WATERTOWN, Mass., Aug. 08, 2019 (GLOBE NEWSWIRE) -- 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 second quarter ended June 30, 2019 and provided a corporate update.

“Our gene therapy program has gained a lot of momentum, most notably with our new strategic partnership with AskBio, which will combine our ImmTOR platform technology with AskBio’s AAV technology and know-how. We believe this partnership will allow us to develop a robust pipeline of products that can potentially be re-dosed and offer patients a new treatment paradigm in areas of high unmet need,” said Carsten Brunn, Ph.D., President and CEO of Selecta. “We are also pleased that the COMPARE trial continues to actively enroll patients, and we look forward to differentiating SEL-212 compared to the current FDA-approved uricase therapy in adult patients with chronic refractory gout. We believe the clinical profile of SEL-212, along with its more convenient monthly dosing, makes it a compelling product for patients and their providers and represents a very large market opportunity of over $1.0 billion.”

Recent Highlights and Anticipated Upcoming Milestones

Chronic Refractory Gout Program:

• COMPARE Clinical Trial of SEL-212 vs. Krystexxa Enrolling Patients: In March 2019, Selecta initiated a six-month head-to-head clinical trial (COMPARE) designed to evaluate the superiority of its lead product candidate, SEL-212 (ImmTOR + Pegadricase), compared to Krystexxa, the current U.S. Food and Drug Administration (FDA)-approved uricase therapy, in adult patients with chronic refractory gout. The COMPARE trial, which is currently enrolling patients, is expected to enroll 150 patients, and the primary endpoint is the maintenance of serum uric acid (sUA) levels of <6mg/dL at six months. An interim data analysis is expected in the fourth quarter of 2019 with a full statistical superiority analysis expected in the second quarter of 2020.

AAV Gene Therapy Program:

• New Strategic Partnership with Gene Therapy Leader AskBio: In August 2019, Selecta announced a strategic partnership with Asklepios BioPharmaceutical, Inc. (AskBio), to jointly develop, manufacture and commercialize a broad portfolio of life-changing, next-generation adeno-associated virus (AAV) gene therapies. This partnership will leverage the unique proprietary technology platforms of both companies with a human proof of concept trial to validate this portfolio of products and their potential for re-dosing in patients.
• Advancing Collaboration with CureCN Consortium: Under a collaboration with the European consortium, CureCN, for an ImmTOR+AAV gene therapy combination product candidate in Crigler-Najjar Syndrome, Selecta expects CureCN to obtain scientific advice from the German drug regulatory authority in the second half of 2019.

Corporate Updates:

• Strengthened Management Team: Selecta announced the appointment of Alison Schecter, M.D., as Chief Medical Officer in July 2019. Dr. Schecter has over 20 years of combined drug development, strategic management and practical clinical experience in academia and industry and joins Selecta from Sanofi, where she was the Global Project Head, Rare Diseases, and was responsible for leading the Niemann-Pick Disease (ASMD) project.
• Expanded Board of Directors: Selecta announced the addition of Scott D. Myers to its Board of Directors, in June 2019. Mr. Myers has more than 20 years of leadership experience in the biopharmaceutical industry and currently serves as Chief Executive Officer and Chairman of the Board of Rainier Therapeutics.

Second Quarter 2019 Financial Results:

• Revenue: For the second quarter ended June 30, 2019, the company recognized less than $0.1 million of revenue under its collaboration agreement with Spark.
• Research and Development Expenses: Research and development expenses for the second quarter ended June 30, 2019 were $12.1 million, which compares with $14.4 million for the second quarter of 2018. Research and development expenses decreased by $2.3 million, or 16%, as compared to the same period in 2018. The decrease reflects the reduced salaries and benefits as a result of the company’s headcount reduction at the beginning of fiscal 2019. There were further cost reductions related to discontinued programs. These cost reductions were offset by the timing of costs incurred for both the company’s Phase 2 and Phase 3 clinical programs for SEL-212.
• General and Administrative Expenses: General and administrative expenses for the second quarter ended June 30, 2019 were $4.1 million, which compares with $4.4 million for the second quarter of 2018. General and administrative expenses decreased by $0.3 million, or 6%, as compared to the same period in 2018. The reduction in costs was primarily the result of reduced legal fees, offset by an increase in professional fees.
• Net Loss: For the second quarter ended June 30, 2019, Selecta reported a net loss of $16.4 million, or $0.37 per share, compared to a net loss of $18.8 million, or $0.84 per share, for the same period in 2018.
• Cash Position: Selecta had $42.0 million in cash, cash equivalents, restricted cash and short-term investments as of June 30, 2019, which compares to cash, cash equivalents, restricted cash and short-term investments of $48.7 million as of March 31, 2019.

Financial Outlook:

Selecta believes its available cash, cash equivalents and restricted cash will be sufficient to meet its operating requirements into the first quarter of 2020.

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.