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Selecta Biosciences Announces Third Quarter 2017 Financial Results and Provides Corporate Update
- Patient Data From Ongoing Phase 2 Trial to be Presented Today at the
American College of Rheumatology(ACR) 2017 Annual Meeting
- Preparations for Phase 3 Program Underway
$7.5 MillionFrom Spark Therapeutics
- Strengthened Senior Management Team
- Company to Host Conference Call Today at
8:30 a.m. ET
“I am excited by the progress we have made to advance SEL-212 closer to its Phase 3 program and by the recent additions to senior management in support of this important milestone,” said
“In the field of gene therapy, we were pleased to have recently received
SEL-212 Program Update
In the fourth quarter of 2016,
- Control and Low SVP-Rapamycin Dose Cohorts (Cohorts receiving five monthly doses of pegsiticase alone or three monthly doses of 0.2 mg/kg or 0.4 mg/kg of pegsiticase + 0.05 mg/kg of SVP-Rapamycin followed by two monthly doses of pegsiticase alone): As previously reported and as expected, dosing of patients in the control cohorts receiving pegsiticase alone was stopped early due to a loss of clinical activity caused by the immunogenicity of the enzyme. Clinical activity was lost by Week 12 in the majority of patients receiving pegsiticase in combination with the 0.05 mg/kg dose of SVP-Rapamycin.
- Mid SVP-Rapamycin Dose Cohorts (Cohorts receiving three monthly doses of 0.2 mg/kg or 0.4 mg/kg of pegsiticase + 0.08 or 0.10 mg/kg of SVP-Rapamycin followed by two monthly doses of pegsiticase alone): A majority of patients in these cohorts maintained clinical activity while receiving the combination therapy through Week 12. These results are consistent with the level of clinical activity observed through Day 30 at a similar SEL-212 dose level in Selecta’s Phase 1b trial. At the 0.1 mg/kg dose level, half of the patients that maintained clinical activity through week 12 also maintained clinical activity through week 20.
- Higher SVP-Rapamycin Dose Cohorts (Cohorts receiving three monthly doses of 0.4 mg/kg of pegsiticase + 0.125 or 0.15 mg/kg of SVP-Rapamycin followed by two monthly doses of pegsiticase alone): Dosing of patients in these cohorts is now ongoing. At a similar dose level in Selecta’s single ascending dose Phase 1b trial, 100 percent of patients achieved clinical activity through Day 30.
ADA levels in the trial continue to strongly correlate with serum uric acid levels. Data show that SVP-Rapamycin reduces the formation of ADAs in a dose-dependent manner, enabling pegsiticase to maintain its clinical activity.
Approximately 24 percent of patients receiving SEL-212 reported a gout flare during their first month of the trial. This is followed by a decline in flare rates during the remainder of the therapy. By comparison, 50% of patients reported a flare during the first month in the control cohorts receiving pegsiticase alone before treatment was stopped due to loss of efficacy and safety.
SEL-212 has been generally well tolerated at clinically active doses following repeated administrations in the trial. There have been 11 serious adverse events reported, four of which were reported to be not related or unlikely related to study drug and seven of which were infusion reactions that were previously reported by the company in its
Additional patient data from these cohorts will be included in a presentation entitled “Selecta Q3 2017 Conference Call Presentation” that will be posted to Selecta’s website by
Other Recent Business Highlights and Activities
- Received Payment From Spark Therapeutics: In
December 2016, Selectaand Spark Therapeuticsentered into license and stock purchase agreements providing Spark Therapeuticswith exclusive worldwide rights to SVP-Rapamycin for co-administration with gene therapy vectors for Hemophilia A and up to four additional pre-specified and undisclosed indications. On October 31, 2017, Selectareceived a payment of $2.5 millionunder the license agreement and proceeds from share purchases under the stock purchase agreement in the amount of $5.0 million, or $7.5 millionin the aggregate, bringing the total amount of proceeds received by Selectafrom Spark Therapeuticsto $30 million. Selectaalso is eligible to receive up to $430 millionin milestone payments for each indication. In addition, Spark Therapeuticswill pay Selectatiered mid-single to low-double-digit royalties on worldwide annual net sales of any resulting commercialized gene therapy.
- Strengthened Senior Management Team: In
October 2017, Selectaannounced two important additions to its management team to further the company’s development with the appointment of John Leaman, M.D., as the company’s new Chief Financial Officer, Treasurer and Head of Corporate Strategy, and the addition of Stephen Smolinskito the newly created role of Chief Commercial Officer. Dr. Leaman most recently served as Head of Corporate Development at InfaCare Pharmaceutical Corp., a specialty pharmaceutical company that was recently acquired by Mallinckrodt plc. Mr. Smolinski most recently served as Vice President and Head of Sanofi/Genzyme’s North American Rheumatology Business Unit.
Third Quarter Financial Results:
- Revenue: For the third quarter of 2017, the company’s total revenue was less than
$0.1 million, which compares with $1.0 millionfor the third quarter of 2016. The decline is primarily the result of 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 third quarter of 2017 were
$9.5 million, which compares with $6.0 millionfor the third 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 third quarter of 2017 were
$4.4 million, which compares with $2.5 millionfor the third quarter of 2016. The increase is primarily the result of greater headcount and related salaries needed to support a clinical-stage public company.
- Net Loss: For the third quarter of 2017,
Selectareported a net loss attributable to common stockholders of $(14.7) million, or $(0.66)per share, compared to a net loss of $(7.7) million, or $(0.43)per share, for the same period in 2016.
- Cash Position:
Selectahad $104.8 millionin cash, cash equivalents, short-term deposits, investments and restricted cash as of September 30, 2017, which compares with a balance of $113.0 millionat June 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.
About Chronic Severe Gout, SEL-212 and Selecta’s Ongoing Phase 2 Trial
According to market research, more than 500,000 gout patients in the U.S. are treated by rheumatologists and approximately 160,000 of these patients have chronic severe gout. These patients typically have an inflammatory build-up of uric acid deposits called tophi in their joints and tissue that causes pain, inflammation of joints and debilitating flares. If untreated, these deposits also can potentially exacerbate kidney and cardiovascular disease and increase morbidity. In fact, a study published in 2016 involving more than 600 patients diagnosed with tophaceous gout showed a 60% increased risk of mortality when compared to more than 2,800 patients without tophi.1
Published data show that uricase enzymes have the unique ability to rapidly eliminate uric acid crystal deposits and tophi in patients with chronic severe gout.2 However, since these are biologic enzymes that are recognized as “foreign” by the immune system, anti-drug antibodies (ADAs) are induced in most patients early in their treatment, compromising efficacy and safety as well as preventing further administrations.
SEL-212 (SVP-Rapamycin in combination with the uricase enzyme pegsiticase) is designed to be the first monthly uricase treatment and the first uricase treatment that avoids immunogenicity. It is intended to remove the patient’s uric acid burden through a short induction treatment cycle, thereby improving acute symptoms such as pain, inflammation of joints and debilitating flares.
In the fourth quarter of 2016,
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)
|September 30, 2017||December 31, 2016|
|Cash and cash equivalents||$||72,151||$||58,656|
|Short-term deposits and investments||32,237||25,485|
|Prepaid expenses and other current assets||2,888||2,382|
|Total current assets||107,352||86,816|
|Property and equipment, net||2,055||2,047|
|Restricted cash and other deposits||316||316|
|Liabilities and stockholders’ equity|
|Loans payable, current portion||—||4,067|
|Deferred revenue, current portion||3,256||1,836|
|Total current liabilities||11,322||13,706|
|Deferred rent and lease incentive||168||222|
|Loans payable, net of current portion||20,954||7,977|
|Deferred revenue, net of current portion||10,953||12,439|
|Other long‑term liabilities||1,250||—|
|Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively.||—||—|
|Common stock, $0.0001 par value; 200,000,000 shares authorized; 22,120,507 and 18,438,742 shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively.||2||1|
|Additional paid-in capital||266,836||211,125|
|Receivable from stock option exercises||—||(75||)|
|Accumulated other comprehensive loss||(4,409||)||(4,518||)|
|Total stockholders’ equity||65,076||54,957|
|Total liabilities and stockholders’ equity||$||109,723||$||89,301|
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Grant and collaboration revenue||$||27||$||1,048||$||190||$||5,153|
|Research and development||9,504||6,021||31,542||18,669|
|General and administrative||4,377||2,495||13,155||7,294|
|Total operating expenses||13,881||8,516||44,697||25,963|
|Loss from operations||(13,854||)||(7,468||)||(44,507||)||(20,810||)|
|Loss on extinguishment of debt||(673||)||—||(673||)||—|
|Foreign currency transaction gain (loss), net||(30||)||(51||)||(113||)||(429||)|
|Other expense, net||(16||)||4||(16||)||(78||)|
|Other comprehensive loss:|
|Foreign currency translation adjustment||(1||)||15||79||416|
|Unrealized gain (loss) on securities||5||16||30||16|
|Accretion of redeemable convertible preferred stock||—||—||—||(4,566||)|
|Net loss attributable to common stockholders||$||(14,676||)||$||(7,728||)||$||(45,777||)||$||(26,693||)|
|Net loss per share attributable to common stockholders|
|Basic and diluted||$||(0.66||)||$||(0.43||)||$||(2.31||)||$||(3.39||)|
|Weighted average common shares outstanding|
|Basic and diluted||22,082,207||18,108,014||19,803,551||7,881,625|
1 Vincent Z et al, Predictors of Mortality in People with Recent Onset of Gout: A Prospective Observational Study, ACR,
2 Araujo E, Bayat S, Petsch C, Matthias E, Faustini F, Kleyer A, Hueber A, Cavallaro A, Lell M, Dalbeth N, et al.
Source: Selecta Biosciences, Inc.