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Selecta Biosciences Announces Fourth Quarter and Year End 2017 Financial Results and Provides Corporate Update
- SEL-212 Severe Gout Program on Track; Additional Phase 2 Data for Higher Dose Cohorts to be Presented on
April 9th or 10th, 2018 at PANLAR Congress
- Phase 1 Clinical Trial of SEL-403 for Mesothelioma Initiated
- Company Reports Year-End 2017 Cash of
$ 97 Millionand Reiterates Runway Through Mid-2019
- Company to Host Conference Call Today at
8:30 a.m. ET
“Several important achievements have been made over the course of the past several months, and we are excited to be in a strong position to execute on our 2018 milestones,” said
Recent Business Highlights and Activities
- Cohorts Added to SEL-212 Phase 2 Trial with Initial Data to be Reported in
April 2018: As of March 9, 2018, a total of 111 patients had been dosed in Selecta’s ongoing Phase 2 trial of SEL-212 (SVP-Rapamycin in combination with pegsiticase) for the treatment of chronic severe gout. Selectahas now fully enrolled cohorts that are receiving three monthly doses of either 0.125 or 0.15 milligrams (mg) per kilogram (kg) of SVP-Rapamycin in combination with either 0.2 or 0.4 mg/kg of pegsiticase followed by two monthly doses of pegsiticase alone. The company plans to report further data from this ongoing trial at the upcoming Pan American League of Associations for Rheumatology (PANLAR) Congresson April 9th or 10th, 2018 and will host a conference call at 8:30 a.m. ETon the day of the presentation.
- Initiated Dosing of SEL-212 Cohort Expected to Receive Five Combination Doses: In
February 2018, Selectabegan enrolling patients in the current Phase 2 trial who are expected to receive five monthly doses of SVP-Rapamycin in combination with pegsiticase. The patients will be receiving SVP-Rapamycin doses ranging from 0.1mg/kg-0.15mg/kg in combination with 0.2mg/kg of pegsiticase. The company expects to present data from these patients at a medical meeting in Q3 2018.
- SEL-212 End of Phase 2 (EOP2) Meeting Planned for Mid-2018 and Plans for Phase 3 Program Initiation in 2018: The
Selectateam is currently compiling the data package for an EOP2 meeting with the FDA, targeted for mid-2018, which will define the company’s design for the Phase 3 program. The team has also begun preparations for the Phase 3 program which the company plans to initiate in 2018.
- SEL-403 Phase 1 Trial Initiated: On
March 8, 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, anti-drug antibody (ADA) levels, as well as an objective response rate assessment.
- Published SEL-403 Preclinical Data in
January 2018:Proceedings of the National Academies of Sciences (PNAS) published a paper in January 2018co-authored by the company and researchers from the NCI. The paper, entitled “Tolerogenic nanoparticles restore the anti-tumor activity of recombinant immunotoxins by mitigating immunogenicity,” focuses on SEL-403 preclinical work conducted by Selectaand Dr. Ira Pastan’slab at the NCI. Dr. Pastan is Senior Investigator, Head, Molecular Biology Section, at NCI’s Center for Cancer Researchand a Fellow of the National Academy of Sciences.
- Enhanced Leadership of the Company:
Selectaannounced the addition of two management team members in the fourth quarter of 2017: Chief Financial Officer and Head of Corporate Strategy John Leaman, M.D., and Chief Commercial Officer Stephen Smolinski. Dr. Leaman most recently served as Head of Corporate Development at InfaCare Pharmaceutical Corp., a specialty pharmaceutical company that was acquired by Mallinckrodt plc. Mr. Smolinski most recently served as Vice President and Head of Sanofi/Genzyme’s North American Rheumatology Business Unit. In early January, the company announced that Dr. Omid Farokhzad, a member of Selecta’s Board and a cofounder of the company, was appointed Chairman of the Board effective December 31, 2017.
- Received Payment from
Spark Therapeutics: In the fourth quarter of 2017, Selectareceived a cash payment of $2.5 millionunder a license agreement, and proceeds from share purchases under a stock purchase agreement in the amount of $5.0 million( $7.5 millionin the aggregate), bringing the total amount of proceeds received by Selectafrom Spark Therapeuticsto $30.0 million. These payments are associated with the December 2016license and stock purchase agreements that provided Spark Therapeuticswith exclusive worldwide rights to SVP-Rapamycin for co-administration with Spark’s gene therapy vectors for Hemophilia A and up to four additional pre-specified and undisclosed indications.
Fourth Quarter Financial Results:
- Revenue: For the fourth quarter of 2017, the company’s total revenue was less than
$0.1 million, which compares with $2.9 millionfor the fourth quarter of 2016. The decline is primarily the result of the termination of the Company’s collaboration with Sanofi, and reduced revenue recognized from the company’s nicotine vaccine candidate grant award from the National Institute on Drug Abuse.
- Research and Development Expenses: Research and development expenses for the fourth quarter of 2017 were
$13.6 million, which compares with $11.0 millionfor the fourth quarter of 2016. The increase is primarily the result of greater clinical costs related to the company’s Phase 2 trial of SEL-212, planning for the SEL-212 Phase 3 program and incremental headcount-related expenses.
- General and Administrative Expenses: General and administrative expenses for the fourth quarter of 2017 were
$5.7 million, which compares with $5.8 millionfor the fourth quarter of 2016. The decrease is primarily the result of greater headcount and related salaries needed to support a clinical-stage public company offset by a reduction in sublicensing payments made to the Massachusetts Institute of Technologyresulting from the agreement with Spark Therapeutics.
- Net Loss: For the fourth quarter of 2017,
Selectareported a net loss attributable to common stockholders of $(19.5) million, or $(0.88)per share, compared to a net loss of $(14.1) million, or $(0.77)per share, for the same period in 2016.
- Cash Position:
Selectahad $97.0 millionin cash, cash equivalents, short-term deposits, investments and restricted cash as of December 31, 2017, which compares with a balance of $104.8 millionat September 30, 2017. Selectacontinues to expect that its cash, cash equivalents, short-term deposits, investments and restricted cash will be sufficient to fund the company’s operating expenses and capital expenditure requirements into mid-2019.
Conference Call Reminder
Any statements in this press release about the future expectations, plans and prospects of
Consolidated Balance Sheets (In thousands, except for shares and par value)
|December 31, 2017||December 31, 2016|
|Cash and cash equivalents||$||70,622||$||58,656|
|Short-term deposits and investments||25,940||25,485|
|Prepaid expenses and other current assets||1,979||2,382|
|Total current assets||98,680||86,816|
|Property and equipment, net||2,091||2,047|
|Restricted cash and other deposits||329||316|
|Liabilities and stockholders’ equity|
|Loans payable, current portion||—||4,067|
|Deferred revenue, current portion||787||1,836|
|Total current liabilities||10,973||13,706|
|Deferred rent and lease incentive||151||222|
|Loans payable, net of current portion||21,042||7,977|
|Deferred revenue, net of current portion||15,919||12,439|
|Other long‑term liabilities||1,201||—|
|Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding at December 31, 2017 and December 31, 2016, respectively||—||—|
|Common stock, $0.0001 par value; 200,000,000 shares authorized; 22,343,254 and 18,438,742 shares issued and outstanding as of December 31, 2017 and December 31, 2016, respectively||3||1|
|Additional paid-in capital||273,128||211,125|
|Receivable from stock option exercises||—||(75||)|
|Accumulated other comprehensive loss||(4,420||)||(4,518||)|
|Total stockholders’ equity||51,814||54,957|
|Total liabilities and stockholders’ equity||$||101,100||$||89,301|
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
|Three Months Ended December 31,||Year Ended December 31,|
|Grant and collaboration revenue||$||17||$||2,930||$||207||$||8,083|
|Research and development||13,623||11,033||45,165||29,702|
|General and administrative||5,671||5,757||18,826||13,051|
|Total operating expenses||19,294||16,790||63,991||42,753|
|Loss from operations||(19,277||)||(13,860||)||(63,784||)||(34,670||)|
|Loss on extinguishment of debt||—||—||(673||)||—|
|Foreign currency transaction gain (loss), net||(10||)||(96||)||(123||)||(525||)|
|Other income (expense), net||(136||)||82||(152||)||4|
|Other comprehensive loss:|
|Foreign currency translation adjustment||(1||)||88||78||504|
|Unrealized gain (loss) on securities||(10||)||(52||)||20||(36||)|
|Total comprehensive loss||$||(19,555||)||$||(14,047||)||$||(65,223||)||$||(35,742||)|
|Accretion of redeemable convertible preferred stock||—||—||—||(4,566||)|
|Net loss attributable to common stockholders||$||(19,544||)||$||(14,083||)||$||(65,321||)||$||(40,776||)|
|Net loss per share attributable to common stockholders:|
|Basic and diluted||$||(0.88||)||$||(0.77||)||$||(3.20||)||$||(3.89||)|
|Weighted average common shares outstanding:|
|Basic and diluted||22,269,282||18,265,771||20,425,050||10,493,939|
Stern Investor Relations, Inc.
Source: Selecta Biosciences, Inc.