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Selecta Biosciences Reports First Quarter 2019 Financial Results and Provides Corporate Update
- Patient enrollment ongoing in COMPARE trial evaluating efficacy and safety of SEL-212 vs. KRYSTEXXA® in patients with chronic refractory gout; interim data expected in 4Q19 -
- Preclinical data showing potential for re-dosing of AAV-based vectors when administered in combination with ImmTOR™ (SVP-Rapamycin) presented at ASGCT 22nd Annual Meeting -
- Company to host conference call today at 8:30 a.m. ET -
“We are excited to be enrolling patients in the COMPARE trial and look forward to the opportunity to differentiate SEL-212 compared to the current
Recent Highlights and Anticipated Upcoming Milestones
SEL-212 (ImmTOR + Pegadricase) for the Treatment of Chronic Refractory Gout:
- Initiated 6-Month COMPARE Clinical Trial of SEL-212 vs. Krystexxa: In
March 2019, Selectainitiated 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 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 six-month data readout is projected in the fourth quarter of 2019 with a full statistical superiority data analysis readout expected in the first quarter of 2020.
- Initiation of Phase 3 Clinical Trial of SEL-212 Anticipated in Q4 19: The interim results of the COMPARE trial, which are anticipated in the fourth quarter of 2019, are expected to inform the design of the Phase 3 clinical trial of SEL-212, which the company plans to initiate in the fourth quarter of 2019.
ImmTOR + AAV Gene Therapy Program:
- Presented New Preclinical Data at the
American Society of Gene & Cell Therapy(ASGCT) 22nd Annual Meeting: In April 2019, Selectascientists and collaborators from the National Institutes of Health(NIH) and the International Centre for Genetic Engineering and Biotechnology(ICGEB) gave five presentations of new preclinical data demonstrating the potential for the re-dosing of adeno-associated virus (AAV)-based gene therapy vectors when administered in combination with its ImmTOR (SVP-Rapamycin) at the ASGCT Annual Meeting in Washington, DC.
- Advancing Collaboration with
CureCN Consortium: Our collaboration with the European consortium, CureCN, for an ImmTOR+AAV gene therapy combination product candidate in Crigler-Najjar Syndrome continues to progress.
- Strengthened Management and Clinical Teams: In
March 2019, Selectaappointed Elona Kogan, J.D. as General Counsel and Secretary. She was most recently General Counsel and head of Government Relations at ARIAD Pharmaceuticals, Inc., a rare disease oncology company, where she was a key executive through the acquisition of the company by Takeda Pharmaceuticals Company Limited. Also, in March, Selectaappointed Horacio Plotkin, MD, FAAP as the new Head of Clinical Development. He brings 20 years of clinical pediatric experience and 12 years in biotech and was most recently Head of Clinical Development, Rare Diseases at Moderna Therapeutics.
First Quarter 2019 Financial Results:
- Revenue: For the first quarter of 2019, the company recognized less than
$0.1 millionof revenue for a shipment under its collaboration agreement with Spark, which compares to zero revenue recognized for the first quarter of 2018.
- Research and Development Expenses: Research and development expenses for the first quarter of 2019 were
$7.4 million, which compares with $11.1 millionfor the first quarter of 2018. The decrease was driven by reduced salaries and benefits as a result of the company’s headcount reduction at the beginning of the first quarter of 2019 combined with expenses incurred for both the Phase 2 and Phase 3 clinical programs for SEL-212.
- General and Administrative Expenses: General and administrative expenses for the first quarter of 2019 were
$4.5 million, which compares with $4.7 millionfor the first quarter of 2018. The reduction in costs was primarily the result of reduced consulting fees.
- Net Loss: For the first quarter of 2019,
Selectareported a net loss of $12.1 million, or $0.31per share, compared to a net loss of $15.9 million, or $0.71per share, for the same period in 2018.
- Cash Position:
Selectahad $48.7 millionin cash, cash equivalents, restricted cash and short-term investments as of March 31, 2019, which compares to cash, cash equivalents and restricted cash of $37.7 millionat December 31, 2018.
Conference Call and Webcast Reminder
Any statements in this press release about the future expectations, plans and prospects of
Consolidated Balance Sheets
(Amounts in thousands, except share data and par value)
|March 31, 2019||December 31, 2018|
|Cash, cash equivalents, and restricted cash||$||32,452||$||37,403|
|Short-term deposits and investments||16,244||—|
|Prepaid expenses and other current assets||10,832||4,673|
|Total current assets||59,528||42,076|
|Property and equipment, net||1,799||2,127|
|Right of Use Asset, net||1,155||—|
|Restricted cash and other assets||—||279|
|Liabilities and stockholders’ equity|
|Loan payable, current portion||21,466||21,385|
|Lease Liability, current portion||1,428||—|
|Deferred revenue, current portion||959||959|
|Total current liabilities||33,046||35,144|
|Deferred rent and lease incentive||—||34|
|Deferred revenue, net of current portion||13,816||13,818|
|Other long‑term liabilities||801||904|
|Stockholders’ equity (deficit):|
|Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively||—||—|
|Common stock, $0.0001 par value; 200,000,000 shares authorized; 44,788,025 and 22,471,776 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively||5||3|
|Additional paid-in capital||311,824||279,539|
|Accumulated other comprehensive loss||(4,533||)||(4,557||)|
|Total stockholders’ equity (deficit)||14,819||(5,418||)|
|Total liabilities and stockholders’ equity||$||62,482||$||44,482|
Consolidated Statements of Operations and Comprehensive Loss
(Amounts in thousands, except share and per share data)
|Three Months Ended March 31,|
|Grant and collaboration revenue||$||10||$||—|
|Research and development||7,353||11,139|
|General and administrative||4,513||4,674|
|Total operating expenses||11,866||15,813|
|Loss from operations||(11,856||)||(15,813||)|
|Foreign currency transaction (loss), net||(30||)||(13||)|
|Other (expense), net||(69||)||—|
|Other comprehensive loss:|
|Foreign currency translation adjustment||22||19|
|Unrealized gain on securities||2||3|
|Total comprehensive loss||$||(12,050||)||$||(15,866||)|
|Net loss per share:|
|Basic and diluted||$||(0.31||)||$||(0.71||)|
|Weighted average common shares outstanding:|
|Basic and diluted||38,447,319||22,345,523|
Stern Investor Relations, Inc.
Source: Selecta Biosciences, Inc.