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- New Data from Ongoing SEL-212 Phase 2
Trial Show Persistent Clinical Activity After Repeat Administrationin Symptomatic Gout Patients
- Emerging Clinical and Preclinical Data Confirm the Broad Potential of Selecta’s Immune Tolerance Platform to Enable Biologics that Avoid Unwanted Immunogenicity
- Company to Host Conference Call Today at
5:00 p.m. ET
“After a pivotal 2016, we believe that 2017 will be a year of great and lasting importance for
“In recent months, we and various collaborators have also presented preclinical data demonstrating the transformative potential of our immune tolerance SVP technology to create novel and differentiated therapies in a number of additional strategic areas such as gene therapy, oncology and enzyme replacement therapy,” continued Cautreels. “We believe SVP has uniquely demonstrated the potential to avoid the immunogenicity that hampers today’s biologic treatments, which is garnering increasing interest throughout the industry.”
SEL-212 Phase 2 Trial Update
Published data show that uricases, exogenous biologic enzymes that metabolize uric acid, have the ability to significantly reduce serum uric acid levels and eliminate uric acid crystal deposits in severe gout patients. However, the efficacy and safety of currently marketed uricases have been compromised by the formation of anti-drug antibodies (ADAs) that are induced in most patients early in their treatment and prevent further administrations. Leveraging the immune tolerance application of Selecta’s SVP platform, SEL-212 (SVP-Rapamycin in combination with pegsiticase) is designed to be the first non-immunogenic version of uricase, which would allow for the effective and safe administration of multiple doses.
A prolonged elevation of serum uric acid levels can lead to the formation of uric acid crystal deposits in joints and tissue. These deposits have been shown to cause severe gout symptoms such as pain, inflammation of joints and debilitating flares, which can potentially exacerbate kidney and cardiovascular disease if untreated. Multi-dose treatment with SEL-212 has the potential to drastically and durably lower serum uric acid levels, enabling the removal of uric acid crystal burden over a short treatment cycle, which cannot be achieved for severe gout patients by oral therapy.
In the fourth quarter of 2016,
Enrollment has been completed for the first six patient cohorts, and recruitment of two additional patient cohorts is ongoing. Serum uric acid data was available as of
- Mid-Dose Cohorts (three monthly doses of 0.08 mg/kg of SVP-Rapamycin + 0.2 mg/kg or 0.4 mg/kg of pegsiticase followed by two monthly doses of pegsiticase alone): Of the 13 patients in these cohorts, 11 patients continue to be dosed and all had maintained serum uric acid control through
March 23, 2017. Nine of these patients had received three monthly doses and the other two patients had received two monthly doses. Of the two patients no longer being dosed, one was removed from the trial for a protocol deviation and one reached the trial’s stopping rules.
- Low-Dose Cohorts (three monthly doses of 0.05 mg/kg of SVP-Rapamycin + 0.2 mg/kg or 0.4 mg/kg of pegsiticase followed by two monthly doses of pegsiticase alone): Of the 19 patients in these cohorts, one patient had completed the full five-month regimen and maintained serum uric acid control for the duration of the trial, and three have received three monthly doses while maintaining serum uric acid control and continue to be dosed. Of the 15 patients no longer being dosed, seven dropped out of the trial and eight reached the trial’s stopping rules.
- Control Cohorts (five monthly doses of 0.2 mg/kg or 0.4 mg/kg of pegsiticase alone) – As expected, based upon the known immunogenicity of uricase enzymes, five of six patients who received pegsiticase alone were unable to maintain serum uric acid control. Consequently, enrollment in these control cohorts was stopped early.
Additional patient data from these cohorts are included in a presentation entitled “Selecta Q4 and Year End 2016 Conference Call Presentation” that
Consistent with the expected reduction in immunogenicity of pegsiticase as SVP-Rapamycin doses increase, SEL-212 has been generally well tolerated thus far in patients in the mid-dose cohorts, with no SAEs being reported for these patients. One infusion reaction was reported in the control cohorts, which was classified as a serious adverse event (SAE) and successfully treated. Two infusion reactions occurred in the low-dose cohorts; they were classified as SAEs and were successfully treated.
Additional Recent Business Highlights and Activities
- Licensed SVP to
Spark Therapeuticsfor up to Five Gene Therapy Indications: In December 2016, Selectaentered into a license agreement providing Spark Therapeuticswith exclusive worldwide rights to SVP-Rapamycin for co-administration with AAV-based gene therapy vectors for Hemophilia A and up to four additional pre-specified and undisclosed indications.
- Advanced its Proprietary Gene Therapy Programs:
Selectahas continued to advance its two proprietary gene therapy programs focused on inborn errors of metabolism: Methylmalonic Acidemia (MMA) and Ornithine Transcarbamylase Deficiency (OTC). In February 2017, Selectaannounced a strategic manufacturing agreement with Lonzafor the production of an Anc80-AAV-based gene therapy product for MMA, which is the more advanced of these programs. Selectaintends to submit an Investigational New Drug (IND) Application for MMA to the FDAin the first half of 2018.
- Teamed with the
National Cancer Institute(NCI): LMB-100 is a next-generation recombinant immunotoxin being developed in the clinic for the treatment of solid tumors. Preclinical data was presented in October 2016by an NCI research team led by Ira Pastan, MD, demonstrating SVP-Rapamycin’s mitigation of ADAs against LMB-100. Selectais collaborating with NCI to advance a combination of SVP-Rapamycin with LMB-100 as a treatment for mesothelioma and pancreatic cancer.
- Announced Pompe Disease Data: Preclinical data was presented in
February 2017by a research team led by Priya Kishnani, MD, Chief of Medical Genetics at Duke University Medical Center, regarding the use of SVP-Rapamycin in combination with alglucosidase alfa (marketed as Myozyme® and Lumizyme®) to treat Pompe disease. The data demonstrate that this combination treatment could mitigate the formation of ADAs against alglucosidase alfa and improve functional outcomes in an animal model of Pompe disease. More broadly, the data demonstrate the potential of Selecta’s immune tolerance SVP technology to mitigate ADAs against enzyme replacement therapies.
- Presented Peanut Allergy and Celiac Disease Data: Preclinical data was presented in
February 2017demonstrating the potential benefit of an SVP-enabled peanut allergy therapeutic vaccine and an SVP-enabled celiac disease treatment. Selectacontinues to evaluate strategic opportunities to advance these programs.
Fourth Quarter Financial Results:
- Revenue: For the fourth quarter of 2016, the company’s total revenue was
$2.9 million, which compares with $2.1 millionfor the same period in the prior year. The increase is primarily the result of accelerated revenue recognition associated with the notification of termination of the company’s collaboration with Sanofias well as initial revenue recognized from the company’s license agreement with Spark Therapeutics.
- Research and Development Expenses: Research and development expenses for the fourth quarter of 2016 were
$11.0 million, which compares with $7.2 millionfor the same period in the prior year. The increase is primarily the result of a milestone payment that was made subject to the company’s pegsiticase license agreement, increased clinical trial-related activities as well as increased salary and stock compensation expense.
- General and Administrative Expenses: General and administrative expenses for the fourth quarter of 2016 were
$5.8 million, which compares with $2.0 millionfor the same period in the prior year. The increase is primarily the result of an SVP-related sublicensing payment made to the Massachusetts Institute of Technologyresulting from Selecta’s license agreement with Spark Therapeuticsas well as increased salary, legal, accounting, consulting and insurance fees associated with being a public company.
- Net Loss: For the fourth quarter of 2016,
Selectareported a net loss attributable to common stockholders of $(14.1) million, or $(0.77)per share, compared to a net loss of $(9.2) million, or $(4.26)per share, for the same period in 2015. The decrease in net loss per share in the most recent quarter is primarily the result of shares of common stock that were issued in the company’s June 2016initial public offering (IPO) and conversion of Selecta’s redeemable preferred stock into common stock in connection with the IPO.
- Cash Position:
Selectahad $84.5 millionin cash, cash equivalents, short-term deposits, investments and restricted cash as of December 31, 2016, which compares with a balance of $79.9 millionat September 30, 2016. The increase is primarily a result of $15.0 millionworth of cash payments from, and stock purchases by, Spark Therapeuticspursuant to the recent license agreement and stock purchase agreement, partially offset by the Selecta’s fourth quarter net operating expenditures.
- Financial Guidance: Based on the cash received in the fourth quarter of 2016 from the company’s recent license agreement and stock purchase agreement with
Spark Therapeuticsand the company’s current operating plans, Selectanow expects that its cash, cash equivalents, short-term deposits, investments and restricted cash will be sufficient to fund the company’s operating expenses and capital expenditure requirements into mid-2018.
Conference Call Reminder
Any statements in this press release about the future expectations, plans and prospects of
|Selecta Biosciences, Inc. and Subsidiaries
Consolidated Balance Sheets
(In thousands, except for shares and par value)
|December 31, 2016||December 31, 2015|
|Cash and cash equivalents||$||58,656||$||32,337|
|Short-term deposits and investments||25,485||4,125|
|Prepaid expenses and other current assets||2,382||1,494|
|Total current assets||86,816||38,913|
|Property and equipment, net||2,047||2,029|
|Restricted cash and other deposits||316||316|
|Liabilities, redeemable convertible preferred stock, and stockholders’ equity (deficit)|
|Loans payable, current portion||4,067||—|
|Deferred revenue, current portion||1,836||1,313|
|Contingently repayable grant funding||—||420|
|Total current liabilities||13,706||7,290|
|Deferred rent and lease incentive||222||105|
|Loans payable, net of current portion||7,977||11,855|
|Deferred revenue, net of current portion||12,439||2,295|
|Other long‑term liabilities||—||290|
|Redeemable Convertible Preferred Stock:|
|Series A redeemable convertible preferred stock, $0.0001 par value; 0 and 2,589,868 shares authorized; 0 and 2,589,868 shares issued and outstanding; as of December 31, 2016 and December 31, 2015 respectively.||—||3,644|
|Series B redeemable convertible preferred stock, $0.0001 par value; 0 and 7,437,325 shares authorized; 0 and 7,437,325 shares issued and outstanding; as of December 31, 2016 and December 31, 2015 respectively.||—||21,448|
|Series C redeemable convertible preferred stock, $0.0001 par value; 0 and 5,000,002 shares authorized; 0 and 5,000,002 shares issued and outstanding; as of December 31, 2016 and December 31, 2015 respectively.||—||20,178|
|Series D redeemable convertible preferred stock, $0.0001 par value; 0 and 8,166,662 shares authorized; 0 and 8,099,994 shares issued and outstanding; as of December 31, 2016 and December 31, 2015 respectively.||—||42,902|
|Series SRN redeemable convertible preferred stock, $0.0001 par value; 0 and 5,611,112 shares authorized; 0 and 2,111,109 shares issued and outstanding; as of December 31, 2016 and December 31, 2015 respectively.||—||12,082|
|Series E redeemable convertible preferred stock, $0.0001 par value; 0 and 9,030,654 shares authorized; 0 and 8,888,888 shares issued and outstanding; as of December 31, 2016 and December 31, 2015 respectively.||—||37,228|
|Total redeemable convertible preferred stock||—||137,482|
|Stockholders’ equity (deficit):|
|Preferred stock, $0.0001 par value; 10,000,000 and 0 shares authorized; 0 shares issued and outstanding at December 31, 2016 and December 31, 2015, respectively.||—||—|
|Common stock, $0.0001 par value; 200,000,000 and 62,164,377 shares authorized at December 31, 2016 and December 31, 2015 respectively; 18,438,742 and 2,180,976 shares issued, 18,438,742 and 2,173,399 shares outstanding as of December 31, 2016 and December 31, 2015, respectively.||1||—|
|Additional paid-in capital||211,125||1|
|Receivable from stock option exercises||(75||)||—|
|Accumulated other comprehensive loss||(4,518||)||(4,986||)|
|Total stockholders’ equity (deficit)||54,957||(116,493||)|
|Total liabilities, redeemable convertible preferred stock and stockholders’ equity||$||89,301||$||42,824|
|Selecta Biosciences, Inc. and Subsidiaries
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited, amounts in thousands, except share and per share data)
|Three Months Ended December 31,||Twelve Months Ended December 31,|
|Grant and collaboration revenue||$||2,930||$||2,134||$||8,083||$||6,011|
|Research and development||11,033||7,211||29,702||22,980|
|General and administrative||5,757||2,030||13,051||8,335|
|Total operating expenses||16,790||9,241||42,753||31,315|
|Loss from operations||(13,860||)||(7,107||)||(34,670||)||(25,304||)|
|Foreign currency transaction gain (loss), net||(96||)||317||(525||)||933|
|Other expense, net||82||24||4||(26||)|
|Other comprehensive loss:|
|Foreign currency translation adjustment||88||(347||)||504||(1,110||)|
|Unrealized gain (loss) on securities||(52||)||—||(36||)||—|
|Accretion of redeemable convertible preferred stock||—||(2,376||)||(4,566||)||(7,335||)|
|Net loss attributable to common stockholders||$||(14,083||)||$||(9,225||)||$||(40,776||)||$||(32,509||)|
|Net loss per share attributable to common stockholders|
|Basic and diluted||$||(0.77||)||$||(4.26||)||$||(3.89||)||$||(15.13||)|
|Weighted average common shares outstanding|
|Basic and diluted||18,265,771||2,167,769||10,493,939||2,150,422|
Jason Fredette Selecta Biosciences, Inc.617-231-8078 email@example.com