On November 8, 2019 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, reported financial results for the third quarter ended September 30, 2019 and provided a corporate update (Press release, Selecta Biosciences, NOV 8, 2019, View Source [SID1234550742]).
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"We have made significant strides this quarter to advance the ImmTOR platform across its potential indications. Preclinical data from our gene therapy program presented at ESGCT demonstrates that ImmTOR prevents the formation of adenoviral vector-induced neutralizing antibodies and has the potential to enable re-administration of therapeutic AAV vectors," said Carsten Brunn, Ph.D., President and CEO of Selecta. "This quarter, we partnered with AskBio, proven leaders in next-generation gene therapy development and scalable manufacturing, to accelerate the innovation of gene therapy medicines. Our chronic refractory gout program continues to advance, and we expect to complete enrollment in our head-to-head COMPARE trial by the end of 2019. We have also strengthened our management team with two recent C-suite additions."
Recent Highlights and Anticipated Upcoming Milestones:
Compelling Preclinical Gene Therapy Data Presented at the European Society of Gene and Cell Therapy (ESGCT): Data from four preclinical studies were presented at the ESGCT Annual Congress in Barcelona, Spain. These studies highlight the ability of ImmTOR to address key challenges in gene therapy, specifically, the re-dosing limitations which stem from adaptive immune responses against the adeno-associated virus (AAV) capsid. These data demonstrate that ImmTOR enables repeat dosing and enhances first dose transgene expression up to four-fold compared to gene therapy with AAV vector alone. These conclusions support the advancement of the Company’s gene therapy pipeline, and Selecta looks forward to the clinical development of its lead gene therapy programs in Methylmalonic Acidemia (MMA) and Ornithine Transcarbamylase (OTC) deficiency.
Announced 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 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. Selecta and AskBio anticipate entering the clinic in 2020.
New SEL-212 Data to be Presented at the American College of Rheumatology Annual Meeting: On November 11, three abstracts of additional data from the Phase 2 dose-ranging study of SEL-212 will be presented at the American College of Rheumatology annual meeting. A press release detailing the results of these studies will be issued following the meeting’s embargo lift.
COMPARE Clinical Trial Expected to be Fully Enrolled by End of 2019: The head-to-head COMPARE study of Selecta’s lead product candidate SEL-212 (ImmTOR + pegadricase) vs. pegloticase (KRYSTEXXA) continues to enroll patients. The trial is evaluating a once-monthly dose of SEL-212 compared to pegloticase, with the primary endpoint of the maintenance of serum uric acid (SUA) levels of <6mg/dL at six months. The COMPARE trial is built upon the Phase 2 dose-ranging study which showed that in the five monthly dose cohorts, SEL-212 maintained SUA levels below 6mg/dL in 66% of evaluable patients, and that only 35% of patients in these cohorts experienced flares in the first month. Selecta expects to report interim data from the COMPARE trial in the first quarter of 2020, with top-line statistical superiority data expected by mid-2020.
Key Regulatory Update for SEL-212: The U.S. Food and Drug Administration (FDA) has granted Selecta a meeting to be held in January 2020, which is expected to inform the design of the Phase 3 clinical trial, and outline requirements for the Biologic License Application (BLA) filing for SEL-212.
Bolstered Balance Sheet with Private Equity Offering: In August 2019, Selecta announced it had raised net proceeds of approximately $5.7 million in a private equity offering to primarily the management team and members of the board of directors of the Company.
Strengthened Management Team: In the third quarter of 2019, Selecta announced the appointments of Dr. Alison D. Schecter as Chief Medical Officer and Brad Dahms as Chief Financial Officer. Dr. Schecter brings more than 20 years of combined drug development, strategic management, and clinical experience in academia and industry. Mr. Dahms brings deep financial and strategic expertise from his experience as an investment banker for life sciences companies.
Third Quarter 2019 Financial Results:
Cash Position: Selecta had $35.9 million in cash, cash equivalents, and restricted cash as of September 30, 2019, which compares to cash, cash equivalents, restricted cash, and short-term investments of $42.0 million as of June 30, 2019.
Research and Development Expenses: Research and development expenses for the third quarter ended September 30, 2019 were $8.1 million, which compares with $11.9 million for the third quarter of 2018, a 32% decrease compared to the same period in 2018. The decrease reflects the timing of expenses recognized for Selecta’s head-to-head COMPARE study, in addition to reduced salaries and benefits resulting from the headcount reduction in early 2019, and the completion of work on prior programs.
General and Administrative Expenses: General and administrative expenses for the third quarter ended September 30, 2019 were $3.7 million, which compares with $4.1 million for the third quarter of 2018, a 9% decrease compared to the same period in 2018. The reduction in costs was primarily the result of reduced legal fees and professional fees.
Net Loss: For the third quarter ended September 30, 2019, Selecta reported a net loss of $12.0 million, or $0.26 per share, compared to a net loss of $16.0 million, or $0.71 per share, for the same period in 2018.
Financial Outlook:
Selecta believes its available cash, cash equivalents, and restricted cash will be sufficient to meet its operating requirements through the first quarter of 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 third quarter 2019 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 10127460.