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Selecta Biosciences Announces First Quarter 2018 Financial Results and Provides Corporate Update
- 3-month Phase 2 data presented at PANLAR 2018 indicate SEL-212 (SVP-Rapamycin + pegsiticase) product profile may provide better and more sustained serum uric acid control, fewer flares, and less frequent dosing compared with recent data reported for current
FDA-approved uricase therapy
- Expansion data from PANLAR cohorts to be presented at EULAR on
June 15th, 2018 and data from patients receiving five doses of SEL-212 expected at Q3 medical conference
- Phase 1 clinical trial for second product candidate, SEL-403, for mesothelioma actively enrolling patients
- Company reports Q1 2018 cash balance of
$84 millionand reiterates runway through mid-2019
- Company to Host Conference Call Today at
8:30 a.m. ET
“We are very pleased by the clinical activity seen in the SEL-212 phase 2 data presented recently at PANLAR, not only in SEL-212’s ability to control serum uric acid levels with convenient monthly doses, but also in the reduced incidence of gout flares compared to the current
Recent Business Highlights and Activities
- Presented Positive New Data from Ongoing Phase 2 Trial of SEL-212 at PANLAR 2018
Congressin April: In April 2018, Selectapresented new data from patients receiving SEL-212 for the treatment of chronic severe gout at the Pan American League of Associations for Rheumatology(PANLAR) 2018 Congressin Buenos Aires, Argentina. The data was generated from patients that received three monthly doses of SEL-212, up to 0.15 mg/kg of SVP-Rapamycin in combination with 0.2 or 0.4 mg/kg of pegsiticase, followed by two monthly doses of pegsiticase alone. Approximately 75% of evaluable patients maintained serum uric acid level control below 6 mg/dl during the initial three months of therapy with concurrent mitigation of anti-drug antibodies (ADAs) against the pegsiticase enzyme. Furthermore, 91% of patients dosed with pegsiticase alone in month four after the initial three monthly doses of SEL-212 maintained serum uric acid control. The company plans to present an expanded data set of the PANLAR cohorts at the EULAR conference on June 15th and will host a conference call to discuss the data on June 15th at 8.30 am.
- Data from Cohorts Receiving Five Combination Doses in Phase 2 Trial of SEL-212 to be Presented in the Third Quarter at a Medical Meeting: In
February 2018, Selectabegan enrolling new cohorts of patients in the current Phase 2 trial who are expected to receive five monthly doses of SVP-Rapamycin in combination with pegsiticase. These patients are receiving SVP-Rapamycin doses ranging from 0.1mg/kg-0.15mg/kg in combination with 0.2 mg/kg of pegsiticase. The company expects to present data from these patients at an upcoming medical meeting in the third quarter of 2018.
- SEL-212 to Enter Phase 3 in 2018 Following Comprehensive Dose Selection Trial:
Selectais actively engaged in preparations for an end-of-Phase 2 meeting with the U.S. Food and Drug Administration( FDA), which will define the company’s design for the Phase 3 program. The company plans to initiate its Phase 3 program in 2018.
- Patient Enrollment Ongoing for SEL-403 Phase 1 Trial for Mesothelioma: In
March 2018, the first patient was dosed in a Phase 1 clinical trial of SEL-403, Selecta’s combination product candidate consisting of SVP-Rapamycin and LMB-100, for the treatment of patients with malignant pleural or peritoneal mesothelioma who have undergone at least one regimen of chemotherapy. LMB-100, which was in-licensed by Selectain 2017, is a recombinant immunotoxin that targets mesothelin, a protein expressed in nearly all mesotheliomas and pancreatic adenocarcinomas, and a high percentage of other malignancies, including lung, breast and ovarian cancers. This open-label dose-escalation Phase 1 trial is being conducted under a Cooperative Researchand Development Agreement (CRADA) with the National Cancer Institute(NCI), part of the National Institutes of Health, and is expected to enroll at least 18 patients. The trial will evaluate the safety and tolerability of this treatment and provide data on pharmacokinetics, ADA levels, as well as an objective response rate assessment.
First Quarter Financial Results:
- Revenue: For the first quarter of 2018, the company recognized no revenue, which compares with
$0.1 millionfor the first 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 first quarter of 2018 were
$11.1 million, relatively unchanged from the $11.0 millionfor the first quarter of 2017.
- General and Administrative Expenses: General and administrative expenses for the first quarter of 2018 were
$4.7 million, which compares with $3.9 millionfor the first quarter of 2017. The increase is primarily the result of greater headcount and related salaries needed to support a maturing clinical-stage public company.
- Net Loss: For the first quarter of 2018,
Selectareported a net loss attributable to common stockholders of $(15.9) million, or $(0.71)per share, compared to a net loss of $(15.1) million, or $(0.82)per share, for the same period in 2017.
- Cash Position:
Selectahad $83.5 millionin cash, cash equivalents, short-term deposits, investments and restricted cash as of March 31, 2018, which compares with a balance of $97.0 millionat December 31, 2017. Selectacontinues to expect that its cash, cash equivalents, short-term deposits, investments and restricted cash will be sufficient to fund the company’s operating expenses and capital expenditure requirements into mid-2019.
Conference Call Reminder
Any statements in this press release about the future expectations, plans and prospects of
Consolidated Balance Sheets
(In thousands, except for shares and par value)
|March 31, 2018||December 31, 2017|
|Cash, cash equivalents, and restricted cash||$||58,304||$||70,698|
|Short-term deposits and investments||24,839||25,940|
|Prepaid expenses and other current assets||1,789||1,979|
|Total current assets||84,984||98,680|
|Property and equipment, net||2,257||2,091|
|Restricted cash and other assets||2,696||329|
|Liabilities and stockholders’ equity|
|Deferred revenue, current portion||959||787|
|Total current liabilities||11,810||10,973|
|Deferred rent and lease incentive||129||151|
|Loans payable, net of current portion||21,127||21,042|
|Deferred revenue, net of current portion||13,917||15,919|
|Other long‑term liabilities||1,372||1,201|
|Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively||—||—|
|Common stock, $0.0001 par value; 200,000,000 shares authorized; 22,349,840 and 22,343,254 shares issued and outstanding as of March 31, 2018 and December 31, 2017, respectively||3||3|
|Additional paid-in capital||274,334||273,128|
|Accumulated other comprehensive loss||(4,398||)||(4,420||)|
|Total stockholders’ equity||41,582||51,814|
|Total liabilities and stockholders’ equity||$||89,937||$||101,100|
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
|Three Months Ended March 31,|
|Grant and collaboration revenue||$||—||$||137|
|Research and development||11,139||11,044|
|General and administrative||4,674||3,875|
|Total operating expenses||15,813||14,919|
|Loss from operations||(15,813||)||(14,782||)|
|Foreign currency transaction gain (loss), net||(13||)||(165||)|
|Other comprehensive loss:|
|Foreign currency translation adjustment||19||123|
|Unrealized gain (loss) on securities||3||15|
|Total comprehensive loss||$||(15,866||)||$||(14,996||)|
|Net loss attributable to common stockholders||$||(15,888||)||$||(15,134||)|
|Net loss per share attributable to common stockholders:|
|Basic and diluted||$||(0.71||)||$||(0.82||)|
|Weighted average common shares outstanding:|
|Basic and diluted||22,345,523||18,474,227|
Source: Selecta Biosciences, Inc.