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Selecta Biosciences Reports Fourth Quarter 2019 and Year-End Financial Results
- Topline results from head-to-head COMPARE trial of SEL-212 in chronic refractory gout expected in Q3 2020 -
- Received guidance from the FDA on SEL-212 Phase 3 clinical trial design; study to commence in 2H 2020 -
- Gene therapy program expected to enter the clinic by the end of 2020 -
- Company to host conference call today at 8:30 AM ET -
“2019 was a pivotal year for
Recent Highlights and Anticipated Upcoming Milestones:
- Topline Results from COMPARE Clinical Trial Expected in the Third Quarter of 2020: In
December 2019, we announced the completion of enrollment in the head-to-head COMPARE study of Selecta’s lead product candidate, SEL-212 (ImmTOR + pegadricase), vs. pegloticase. Topline data from this trial is expected in the third quarter of 2020. The trial is evaluating a once-monthly dose of SEL-212 compared to biweekly doses of pegloticase, with the primary endpoint of the maintenance of serum uric acid (SUA) levels of <6mg/dL at three and six months.
- Meeting with FDA Provides Clarity on Phase 3 Clinical Program of SEL-212:
Selectaheld a meeting with the U.S. Food and Drug Administration(FDA) in January 2020to inform the design of the planned Phase 3 clinical program. Selectaplans to commence its Phase 3 clinical program of SEL-212 against placebo in the second half of 2020.
- Gene Therapy Program in the Clinic by the End of 2020: In
August 2019, Selectaannounced a strategic partnership with Asklepios BioPharmaceutical, Inc.(AskBio), to jointly develop, manufacture, and commercialize a broad portfolio of 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, which could represent a significant advancement in the gene therapy field. Selectaand AskBio anticipate entering the clinic by the end of 2020. Additionally, the Company intends to advance its proprietary program in ornithine transcarbamylase (OTC) deficiency.
Broadened Strategic Partnershipwith AskBio: In December 2019, Selectaand AskBio jointly announced that the companies entered into a license agreement under which AskBio exercised its option to exclusively license rights to develop and commercialize Selecta’s immune tolerance platform, ImmTOR, for use in adeno-associated virus (AAV) gene therapy for the treatment of Pompe disease. Affecting 5,000-10,000 people worldwide, Pompe disease is a rare, genetic, lysosomal storage disease characterized by the abnormal buildup of a sugar molecule called glycogen inside cells. Under the terms of the agreement, Selectareceived upfront payments of $7 millionand is eligible to receive milestone payments of $237 millionplus royalties on product sales.
$70 Millionin a Private Placement: In December 2019, Selectaannounced the closing of a transaction to sell securities in a private placement with institutional investors and certain members of the Company’s Board of Directors, resulting in gross proceeds of approximately $70 million.
- Strengthened Board of Directors: In
November 2019, Selectaannounced the appointment of Carrie S. Coxto the position of Chairman of the Board of Directors. A renowned industry leader and successful biopharmaceutical executive, Ms. Coxhas served on multiple Boards, and has held the position of Chair, for several biopharmaceutical companies.
Fourth Quarter and Full Year 2019 Financial Results:
- Cash Position:
Selectahad $91.6 millionin cash, cash equivalents, and restricted cash as of December 31, 2019, which compares to cash, cash equivalents, restricted cash, and short-term investments of $35.9 millionas of September 30, 2019. Selectabelieves its available cash, cash equivalents, and restricted cash will be sufficient to meet its operating requirements into the first quarter of 2021.
- Net cash used in operating activities was
$12.9 millionand $51.4 millionfor the fourth quarter and fiscal year 2019, respectively, as compared to $12.7 millionand $59.2 millionfor the same periods in 2018.
- Net cash used in operating activities was
- Research and Development Expenses: Research and development expenses for the fourth quarter and fiscal year 2019 were
$15.2 millionand $42.7 million, respectively, which compares with $10.3 millionand $47.7 millionfor the same periods in 2018. The quarterly increase reflects additional costs incurred specific to our Phase 2 head-to-head (COMPARE) clinical trial of SEL-212, for which we completed enrollment in December 2019. The decrease year over year reflects reduced costs in 2019 due to the completion of prior programs in 2018, combined with reduced salaries and benefits resulting from the headcount reduction in early 2019. The cost reductions were offset by an overall increase in costs incurred on our lead product candidate, SEL-212.
- General and Administrative Expenses: General and administrative expenses for the fourth quarter and fiscal year 2019 were
$4.1 millionand $16.4 million, respectively, which compares with $5.1 millionand $18.2 millionfor the same periods in 2018. The decrease is the result of lower salaries and stock compensation expense resulting from reduced headcount at the end of 2018, combined with reduced patent and professional fees.
- Net Loss: For the fourth quarter and fiscal year 2019,
Selectareported a net loss of $14.9 million, or $0.28per share and $55.4 million, or $1.22per share, compared to a net loss of $14.7 million, or $0.65per share, and $65.3 million, or $2.92per share, for the same periods in 2018.
Conference Call and Webcast Reminder:
Any statements in this press release about the future expectations, plans and prospects of
Consolidated Balance Sheets
(Amounts in thousands, except share data and par value)
|Cash and cash equivalents||$||89,893||$||37,403|
|Prepaid expenses and other current assets||1,495||4,673|
|Total current assets||96,667||42,076|
|Property and equipment, net||1,222||2,127|
|Right-of-use asset, net||301||—|
|Long-term restricted cash||1,379||279|
|Liabilities and stockholders’ equity (deficit)|
|Total current liabilities||34,943||35,144|
|Other long‑term liabilities||—||938|
|Stockholders’ equity (deficit):|
|Additional paid-in capital||348,664||279,539|
|Accumulated other comprehensive loss||(4,523||)||(4,557||)|
|Total stockholders’ equity (deficit)||8,397||(5,418||)|
|Total liabilities and stockholders’ equity (deficit)||$||99,569||$||44,482|
Consolidated Statements of Operations and Comprehensive Loss
(Amounts in thousands, except share data and per share data)
|Three Months Ended
|Grant and collaboration revenue||$||6,654||$||903||$||6,677||$||903|
|Research and development||15,152||10,256||42,743||47,687|
|General and administrative||4,072||5,146||16,389||18,238|
|Total operating expenses||19,224||15,402||59,132||65,925|
|Loss from operations||(12,570||)||(14,499||)||(52,455||)||(65,022||)|
|Foreign currency transaction (loss), net||(14||)||23||(47||)||120|
|Change in fair value of warrant liabilities||(857||)||—||(857||)||—|
|Other (expense), net||(1,239||)||(1||)||(1,306||)||10|
|Other comprehensive loss:|
|Foreign currency translation adjustment||10||(40||)||34||(153||)|
|Unrealized gain on securities||—||—||—||16|
|Total comprehensive loss||$||(14,878||)||$||(14,691||)||$||(55,316||)||$||(65,473||)|
|Net loss per share:|
|Basic and diluted||$||(0.28||)||$||(0.65||)||$||(1.22||)||$||(2.92||)|
|Weighted average common shares outstanding:|
|Basic and diluted||52,321,884||22,450,828||45,548,511||22,389,286|
Source: Selecta Biosciences, Inc.