On November 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, reported financial results for the third quarter ended September 30, 2018 and provided a corporate update (Press release, Selecta Biosciences, NOV 8, 2018, View Source [SID1234531037]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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
SEL-212 6-Month Head-to-Head Trial vs. Krystexxa Expected to Begin in 1Q 2019:Selecta plans to start a head-to-head superiority trial of SEL-212 compared to the current FDA-approved uricase therapy, Krystexxa, in the first quarter of 2019. Selecta expects to report interim data at the 3-month and 6-month timepoints in 2019 with full data anticipated in the first quarter of 2020.
Presented New Interim Phase 2 Clinical Data from Patients Receiving 5-Monthly Doses of SEL-212 at ACR 2018: At the 2018 American College of Rheumatology (ACR)/Association for Rheumatology Health Professionals (ARHP) Annual Meeting in Chicago, Selecta presented interim data from new cohorts of patients that received five monthly doses of SEL-212 for the 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.
Announced Collaboration with CureCN for the Exploration of Clinical Use of SVP-Rapamycin in Combination with AAV Gene Therapy for Treatment of Crigler-Najjar Syndrome (CN): The company announced its exploration of a new collaboration with CureCN, a European consortium, for the use of Selecta’s SVP-Rapamycin technology in combination with an AAV gene therapy in CN, a rare genetic disorder characterized by an inability to properly convert and clear bilirubin from the body. Preclinical toxicology studies will need to be completed and then the combination product candidate is projected to enter the clinic in the second half of 2019 with the goal of potentially re-dosing gene therapy. This opportunity builds upon preclinical work that was published together with Genethon in Nature Communications in October 2018.
Appointed Carsten Brunn, Ph.D. as President and Chief Executive Officer: In September 2018, the company announced that Carsten Brunn, Ph.D., had been appointed President and Chief Executive Officer of Selecta Biosciences, effective December 1, 2018. He will also serve on the company’s Board of Directors. Current President and CEO, Werner Cautreels, Ph.D., will continue to lead the company until December, will assist Dr. Brunn during the transition and will remain a member of the Board through December 31, 2018. Dr. Cautreels is expected to serve as an advisor to the company following his retirement. Dr. Brunn joins Selecta from Bayer, where he was most recently the President of Pharmaceuticals for the Americas Region and a member of the Global Pharmaceutical Executive Committee.
Third Quarter 2018 Financial Results:
Revenue: For the third quarter of 2018, the company recognized no revenue, which compares to less than $0.1 million for the third quarter of 2017. The decline is the result of reduced revenue recognized from the company’s grants and collaborations.
Research and Development Expenses: Research and development expenses for the third quarter of 2018 were $11.9 million, which compares to $9.5 million for the third quarter of 2017. The increase is primarily the result of higher clinical costs related to the company’s Phase 2 trial of SEL-212, preparation for the start of the planned SEL-212 Phase 3 program and head-to-head clinical trial, and incremental headcount-related expenses.
General and Administrative Expenses: General and administrative expenses for the third quarter of 2018 were $4.1 million, which compares with $4.4 million for the third quarter of 2017. The reduction in costs is primarily the result of reduced employee salaries and benefits and patent related costs.
Net Loss: For the third quarter of 2018, Selecta reported a net loss of $(16.0) million, or $(0.71) per share, compared to a net loss of $(14.7) million, or $(0.66) per share, for the same period in 2017.
Cash Position: Selecta had $50.5 million in cash and cash equivalents as of September 30, 2018, which compares to cash, cash equivalents and short-term investments of $66.2 million at June 30, 2018. The current operating plan accounts for funding in preparation for the planned Phase 3 clinical 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, View Source 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.