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Selecta Biosciences Announces Second Quarter 2018 Financial Results and Provides Corporate Update
- Expanded three-month Phase 2 data presented at EULAR 2018 continue to indicate that SEL-212 product profile may provide better and more sustained serum uric acid control, fewer flares and less frequent dosing compared with data reported for current
FDA-approved uricase therapy
- Data from patients receiving five monthly doses of SEL-212 expected to be presented at the
American College of Rheumatology(ACR) Annual Meeting in October 2018
- SEL-212 Phase 3 pivotal program expected to begin in Q4 2018 with a planned head-to-head trial against Krystexxa conducted in parallel
- Enrollment ongoing for SEL-403 Phase 1 trial for mesothelioma, company working with NCI to potentially expand clinical studies for treatment in pancreatic cancer
- Company to host conference call today at
8:30 a.m. ET
“The continued improvement in clinical activity observed in the expanded patient data set recently presented at the EULAR conference in June further demonstrates the benefit SEL-212 may provide to chronic severe gout patients and its potential ability to change the current treatment paradigm in these patients with high medical need,” said
Recent Highlights and Anticipated Upcoming Milestones
- Presented New Expansion Data from Ongoing Phase 2 Trial of SEL-212 at the European League Against Rheumatism (EULAR) 2018 in June: In
June 2018, Selectapresented new expansion data from patients receiving SEL-212 for the treatment of chronic severe gout at EULAR 2018 in Amsterdam, the Netherlands. The data was from patients receiving 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 80% of evaluable patients (n=27) had serum uric acid control below 6 mg/dl at week 12. In a separately conducted and designed study of the only FDA-approved uricase therapy, 44% of evaluable patients had serum uric acid control below 6 mg/dl at week 16.33% of the patient population represented by our EULAR data, and only 27% of all current patients in the SEL-212 Phase 2 trial, experienced gout flares during the first month after treatment with continued reduction of gout flare rates over months two to five. This reduced rate of gout flares appears to be substantially lower than the incidence of gout flares reported in clinical trials involving the current FDA-approved uricase and other uric acid lowering therapies.
- Data from Cohorts Receiving Five Combination Doses in Ongoing Phase 2 Trial of SEL-212 to be Presented at the ACR Annual Meeting scheduled for
October 19-24, 2018: The company expects to present data from new cohorts of patients in the ongoing Phase 2 trial who are receiving five monthly doses of SVP-Rapamycin in combination with pegsiticase at the upcoming ACR meeting scheduled for October 19-24, 2018. These patients are receiving SVP-Rapamycin doses ranging from 0.10 - 0.15mg/kg in combination with 0.2mg/kg of pegsiticase.
- Active Preparations Underway for SEL-212 Phase 3 Clinical Program and Expected Initiation of Patient Enrollment in Fourth Quarter of 2018:
Selectais actively preparing for the start of a pivotal Phase 3 program for SEL-212, and plans to initiate patient enrollment in the fourth quarter of 2018 in a couple of clinical trial sites. The company expects to evaluate maintenance of serum uric acid control below 6 mg/dl at month three and month six as the primary clinical endpoint in two placebo-controlled clinical trials. The company’s end-of-Phase 2 meeting with the U.S. Food and Drug Administration( FDA) will define the company’s design for the Phase 3 program.
- Active Preparations Underway for Head-to-Head Trial of SEL-212 Versus the Current FDA-Approved Uricase Therapy, Krystexxa: The company is actively preparing to start a head-to-head clinical trial of SEL-212 compared to the current
FDA-approved uricase therapy, Krystexxa, which will be designed to have the potential to demonstrate superiority. Selectaplans to initiate this trial in parallel with the Phase 3 program and expects to report clinical data at both the three month and six month time points in 2019.
- Patient Enrollment Ongoing for SEL-403 Phase 1 Trial for Mesothelioma: The company is actively dosing patients in an open-label dose-finding 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. The trial is being conducted in cooperation with the
National Cancer Institute(NCI), part of the National Institutes of Health, and will evaluate the safety and tolerability of this treatment and provide data on pharmacokinetics, anti-drug antibody levels, as well as an objective response rate assessment. The company is also working with investigators at the NCI to potentially conduct a Phase 1 study of SEL-403 in patients with pancreatic cancer, and is further exploring additional studies in other cancers.
- Preclinical Work Continues in Gene Therapy: Previously presented data from the 2017 annual meetings of the
American Society of Gene & Cell Therapyand the European Society of Gene and Cell Therapyhave provided evidence for the potential of SVP-Rapamycin to unlock the full potential of this novel modality. The company continues to engage in preclinical work focused on its proprietary product candidate for the treatment of methylmalonic acidemia, as well as in support of its collaboration with Spark Therapeutics.
Second Quarter 2018 Financial Results:
- Revenue: For the second quarter of 2018, the company recognized no revenue, which compares to less than
$0.1 millionfor the second 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 second quarter of 2018 were
$14.4 million, which compares to $11.0 millionfor the second quarter of 2017. The increase is primarily the result of higher clinical costs related to the company’s Phase 2 trial of SEL-212, preparation for the start of the SEL-212 Phase 3 program and incremental headcount-related expenses.
- General and Administrative Expenses: General and administrative expenses for the second quarter of 2018 were
$4.4 million, which compares with $4.9 millionfor the second quarter of 2017. The reduction in costs is primarily the result of reduced patent related costs and contract license fees associated with collaborations.
- Net Loss: For the second quarter of 2018,
Selectareported a net loss of $(18.8) million, or $(0.84)per share, compared to a net loss of $(16.0) million, or $(0.85)per share, for the same period in 2017.
- Cash Position:
Selectahad $66.2 millionin cash, cash equivalents, short-term deposits and investments as of June 30, 2018, which compares with a balance of $83.1 millionat March 31, 2018. Selectaexpects that its cash, cash equivalents, short-term deposits and investments will be sufficient to fund the company’s operating expenses and capital expenditure requirements through the end of the third quarter of 2019. The current operating plan accounts for funding in preparation for the planned Phase 3 clinical trial for SEL-212 and initial patient enrollment into a couple of Phase 3 clinical trial sites, but the company will require an additional equity offering or other external sources of capital to expand enrollment in the Phase 3 trial and to conduct the planned head-to-head trial against Krystexxa.
Conference Call Reminder
Any statements in this press release about the future expectations, plans and prospects of
Consolidated Balance Sheets
(In thousands, except for shares and par value)
|June 30, 2018||December 31, 2017|
|Cash, cash equivalents, and restricted cash||$||60,237||$||70,698|
|Short-term deposits and investments||5,991||25,940|
|Prepaid expenses and other current assets||2,607||2,042|
|Total current assets||68,835||98,680|
|Property and equipment, net||2,137||2,091|
|Restricted cash and other assets||2,465||329|
|Liabilities and stockholders’ equity|
|Deferred revenue, current portion||1,918||787|
|Total current liabilities||13,891||10,973|
|Deferred rent and lease incentive||98||151|
|Deferred revenue, net of current portion||12,870||15,919|
|Other long‑term liabilities||1,104||1,201|
|Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively||—||—|
|Common stock, $0.0001 par value; 200,000,000 shares authorized; 22,396,183 and 22,343,254 shares issued and outstanding as of June 30, 2018 and December 31, 2017, respectively||3||3|
|Additional paid-in capital||275,888||273,128|
|Accumulated other comprehensive loss||(4,476||)||(4,420||)|
|Total stockholders’ equity||24,262||51,814|
|Total liabilities and stockholders’ equity||$||73,437||$||101,100|
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
|Three Months Ended June 30,||Six Months Ended June 30,|
|Grant and collaboration revenue||$||—||$||26||$||—||$||163|
|Research and development||14,407||10,994||25,546||22,038|
|General and administrative||4,362||4,903||9,036||8,778|
|Total operating expenses||18,769||15,897||34,582||30,816|
|Loss from operations||(18,769||)||(15,871||)||(34,582||)||(30,653||)|
|Foreign currency transaction gain (loss), net||84||82||71||(83||)|
|Other income (expense), net||8||—||8||—|
|Other comprehensive loss:|
|Foreign currency translation adjustment||(90||)||(43||)||(71||)||80|
|Unrealized gain on securities||12||10||15||25|
|Total comprehensive loss||$||(18,874||)||$||(16,000||)||$||(34,740||)||$||(30,996||)|
|Net loss per share:|
|Basic and diluted||$||(0.84||)||$||(0.85||)||$||(1.55||)||$||(1.67||)|
|Weighted average common shares outstanding:|
|Basic and diluted||22,355,603||18,814,570||22,350,591||18,645,339|
Stern Investor Relations, Inc.
Source: Selecta Biosciences, Inc.