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SELECTA BIOSCIENCES, INC.
Date: August 6, 2020
/s/ Carsten Brunn, Ph.D.
Carsten Brunn, Ph.D.
President and Chief Executive Officer
Closed strategic licensing agreement with Sobi for SEL-212 for $100 million in initial payments and up to $630 million in potential milestones, and tiered double-digit royalties
Entered into research license and option agreement with Sarepta for the use of the ImmTOR™ immune tolerance platform in Sarepta’s gene therapy programs in certain neuromuscular diseases
Gene therapy program in MMA in collaboration with AskBio on track to enter the clinic in the first half of 2021; preliminary data expected in the second half of 2021
Phase 3 clinical program of SEL-212 to commence with Sobi in Q3 2020; on track to report topline data from ongoing head-to-head COMPARE trial in Q3 2020
Cash runway into the first quarter of 2023
Company to host conference call today at 8:30 a.m. ET
Closed Strategic Licensing Agreement with Sobi for SEL-212, the Company’s Phase 3-ready Novel Treatment for Chronic Refractory Gout: The Company announced the closing of a strategic licensing agreement with Sobi for SEL-212, the Company’s lead product candidate
Entered into Research License and Option Agreement with Sarepta for the Use of ImmTOR in Certain Neuromuscular Diseases: Selecta and Sarepta reached an agreement which provides Sarepta with the option to license the rights to develop and commercialize the ImmTOR platform for use in select neuromuscular diseases; Duchenne muscular dystrophy (DMD) and certain limb-girdle muscular dystrophies (LGMDs). Sarepta will evaluate its investigational gene therapies in combination with ImmTOR to mitigate the formation of neutralizing antibodies. Sarepta has made an initial payment to Selecta, and Selecta is eligible to receive certain pre-clinical milestone fees.
Two Key Clinical Milestones for SEL-212: Selecta and Sobi anticipate initiating the Phase 3 clinical program in the third quarter of 2020. Selecta will take the lead running the Phase 3 program, at Sobi’s expense. The Phase 3 clinical program will consist of two double blinded, placebo-controlled trials of SEL-212. Each trial is expected to enroll 105 patients and have 35 patients receiving 0.1 mg/kg of ImmTOR and 0.2 mg/kg of pegadricase, 35 patients receiving 0.15 mg/kg of ImmTOR and 0.2 mg/kg of pegadricase, and 35 patients receiving placebo. The primary endpoint of the Phase 3 clinical trials is the maintenance of serum uric acid (SUA) levels of <6mg/dL at six months. One of the trials will have a six-month extension. In addition, the Company expects topline results from the Phase 2 COMPARE clinical trial in Q3 2020. This head-to-head study of a once-monthly dose of SEL-212 (ImmTOR + pegadricase) compared to biweekly doses of pegloticase is expected to read out on schedule. The primary endpoint of the COMPARE trial is the maintenance of serum uric acid (SUA) levels of <6mg/dL at three and six months.
Timeline for Gene Therapy and Autoimmune Diseases Programs Confirmed: The Company’s gene therapy program in methylmalonic acidemia, or MMA, in collaboration with AskBio, is expected to enter the clinic in the first half of 2021, with preliminary data expected in 2H 2021. In addition, Selecta intends to submit its Investigational New Drug Application (IND) for its autoimmune disease program in 2021. The first indication will be IgA nephropathy, a kidney disease that occurs when an antibody called immunoglobulin A (IgA) accumulates in the kidneys. The second indication is expected to be primary biliary cholangitis, or PBC, an autoimmune disease that causes progressive destruction of the bile ducts. Both diseases have well-defined target antigens, significant unmet medical need, and are well suited to the application of Selecta’s ImmTOR immune tolerance platform.
Appointed Peter G. Traber, MD, to the Position of Chief Medical Officer: Dr. Traber, who has been serving in the same position in an interim capacity, joined the Company full-time as of August 1, 2020. Dr. Traber has a broad range of experience in large pharma, biotech, and academia, and will oversee medical affairs, program management, and all aspects of clinical
Cash Position: Selecta had $61.4 million in cash, cash equivalents, and restricted cash as of June 30, 2020, which compares to cash, cash equivalents, and restricted cash of $91.6 million as of December 31, 2019. Selecta believes its available cash, cash equivalents, and restricted cash as of June 30, 2020, together with the $25 million payment received from Sobi under the Sobi Private Placement in July and the expected payment from Sobi of $75 million under the Sobi License, which is due 45 days after the effective date, will enable Selecta to fund operating expenses and capital expenditure requirements into the first quarter of 2023.
Net cash used in operating activities was $23.5 million for the six months ended June 30, 2020, as compared to $27.4 million for the same period in 2019.
Research and Development Expenses: Research and development expenses for the second quarter 2020 were $10.7 million, which compares with $12.1 million for the same period in 2019. The decrease in costs was primarily the result of reduced expense for the Phase 2 COMPARE trial for SEL-212 offset by increases for the gene therapy program in collaboration with AskBio, and salaries and benefits.
General and Administrative Expenses: General and administrative expenses for the second quarter 2020 were $5.6 million, which compares with $4.1 million for the same period in 2019. The increase in costs was the result of expenses incurred for salaries, legal and professional fees offset by decreased travel expense.
Net Loss: For the second quarter 2020, Selecta reported a net loss of $24.1 million, or $0.25 per share, compared to a net loss of $16.4 million, or $0.37 per share, for the same period in 2019.
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