On May 9, 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 first quarter ended March 31, 2018 and provided a corporate update (Press release, Selecta Biosciences, MAY 9, 2018, View Source [SID1234526391]).
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"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 FDA-approved uricase. We have two more anticipated data readouts from this trial at EULAR and a medical conference in the third quarter and we are also planning to initiate the Phase 3 program later this year," said Werner Cautreels, Ph.D., President and CEO of Selecta. "And now that our next program, SEL-403, has entered the clinic for the treatment of patients with mesothelioma at the National Cancer Institute, we have demonstrated the versatility of our tolerance SVP platform in an additional therapeutic area of high unmet need. SEL-403 is the first non-immunogenic immunotoxin that targets mesothelin on cancer cells providing the possibility of improving efficacy and safety for a broad group of cancer patients."
Recent Business Highlights and Activities
Presented Positive New Data from Ongoing Phase 2 Trial of SEL-212 at PANLAR 2018 Congress in April: In April 2018, Selecta presented 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 Congress in 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, Selecta began 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:Selecta is 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 Selecta in 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 Research and 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 million for 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 million for 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 million for 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, Selecta reported 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: Selecta had $83.5 million in cash, cash equivalents, short-term deposits, investments and restricted cash as of March 31, 2018, which compares with a balance of $97.0 million at December 31, 2017. Selecta continues 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
Selecta management will host a conference call at 8:30 a.m. ET today to announce the company’s first quarter financial results and provide a corporate update. 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 10118841.