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Selecta Biosciences Reports Third Quarter 2019 Financial Results and Provides Corporate Update
- Compelling preclinical data presented at the
- COMPARE head-to-head trial of SEL-212 in chronic refractory gout expected to be fully enrolled by the end of 2019; confirmed
- Strengthened management team with appointments of
- Company to host conference call today at 8:30 AM ET -
“We have made significant strides this quarter to advance the ImmTOR platform across its potential indications. Preclinical data from our gene therapy program presented at ESGCT demonstrates that ImmTOR prevents the formation of adenoviral vector-induced neutralizing antibodies and has the potential to enable re-administration of therapeutic AAV vectors,” said
Recent Highlights and Anticipated Upcoming Milestones:
- Compelling Preclinical Gene Therapy Data Presented at the
European Society of Gene and Cell Therapy(ESGCT): Data from four preclinical studies were presented at the ESGCT Annual Congress in Barcelona, Spain. These studies highlight the ability of ImmTOR to address key challenges in gene therapy, specifically, the re-dosing limitations which stem from adaptive immune responses against the adeno-associated virus (AAV) capsid. These data demonstrate that ImmTOR enables repeat dosing and enhances first dose transgene expression up to four-fold compared to gene therapy with AAV vector alone. These conclusions support the advancement of the Company’s gene therapy pipeline, and Selectalooks forward to the clinical development of its lead gene therapy programs in Methylmalonic Acidemia (MMA) and Ornithine Transcarbamylase (OTC) deficiency.
Announced Strategic Partnershipwith Gene Therapy Leader AskBio: In August 2019, Selectaannounced a strategic partnership with Asklepios BioPharmaceutical, Inc.(AskBio), to jointly develop, manufacture, and commercialize a broad portfolio of life-changing, next-generation AAV gene therapies. This partnership will leverage the unique proprietary technology platforms of both companies with a human proof of concept trial to validate this portfolio of products and their potential for re-dosing in patients. Selectaand AskBio anticipate entering the clinic in 2020.
- New SEL-212 Data to be Presented at the
American College of RheumatologyAnnual Meeting: On November 11, three abstracts of additional data from the Phase 2 dose-ranging study of SEL-212 will be presented at the American College of Rheumatologyannual meeting. A press release detailing the results of these studies will be issued following the meeting’s embargo lift.
- COMPARE Clinical Trial Expected to be Fully Enrolled by End of 2019: The head-to-head COMPARE study of Selecta’s lead product candidate SEL-212 (ImmTOR + pegadricase) vs. pegloticase (KRYSTEXXA®) continues to enroll patients. The trial is evaluating a once-monthly dose of SEL-212 compared to pegloticase, with the primary endpoint of the maintenance of serum uric acid (SUA) levels of <6mg/dL at six months. The COMPARE trial is built upon the Phase 2 dose-ranging study which showed that in the five monthly dose cohorts, SEL-212 maintained SUA levels below 6mg/dL in 66% of evaluable patients, and that only 35% of patients in these cohorts experienced flares in the first month.
Selectaexpects to report interim data from the COMPARE trial in the first quarter of 2020, with top-line statistical superiority data expected by mid-2020.
- Key Regulatory Update for SEL-212:
The U.S. Food and Drug Administration( FDA) has granted Selectaa meeting to be held in January 2020, which is expected to inform the design of the Phase 3 clinical trial, and outline requirements for the Biologic License Application (BLA) filing for SEL-212.
- Bolstered Balance Sheet with Private Equity Offering: In
August 2019, Selectaannounced it had raised net proceeds of approximately $5.7 millionin a private equity offering to primarily the management team and members of the board of directors of the Company.
- Strengthened Management Team: In the third quarter of 2019,
Selectaannounced the appointments of Dr. Alison D. Schecteras Chief Medical Officer and Brad Dahmsas Chief Financial Officer. Dr. Schecter brings more than 20 years of combined drug development, strategic management, and clinical experience in academia and industry. Mr. Dahms brings deep financial and strategic expertise from his experience as an investment banker for life sciences companies.
Third Quarter 2019 Financial Results:
- Cash Position:
Selectahad $35.9 millionin cash, cash equivalents, and restricted cash as of September 30, 2019, which compares to cash, cash equivalents, restricted cash, and short-term investments of $42.0 millionas of June 30, 2019.
- Research and Development Expenses: Research and development expenses for the third quarter ended
September 30, 2019were $8.1 million, which compares with $11.9 millionfor the third quarter of 2018, a 32% decrease compared to the same period in 2018. The decrease reflects the timing of expenses recognized for Selecta’s head-to-head COMPARE study, in addition to reduced salaries and benefits resulting from the headcount reduction in early 2019, and the completion of work on prior programs.
- General and Administrative Expenses: General and administrative expenses for the third quarter ended
September 30, 2019were $3.7 million, which compares with $4.1 millionfor the third quarter of 2018, a 9% decrease compared to the same period in 2018. The reduction in costs was primarily the result of reduced legal fees and professional fees.
- Net Loss: For the third quarter ended
September 30, 2019, Selectareported a net loss of $12.0 million, or $0.26per share, compared to a net loss of $16.0 million, or $0.71per share, for the same period in 2018.
Conference Call and Webcast Reminder:
About Selecta Biosciences, Inc.
Any statements in this press release about the future expectations, plans and prospects of
Consolidated Balance Sheets
(Amounts in thousands, except share data and par value)
|September 30, 2019||December 31, 2018|
|Cash, cash equivalents, and restricted cash||$||34,513||$||37,403|
|Prepaid expenses and other current assets||1,606||4,673|
|Total current assets||36,119||42,076|
|Property and equipment, net||1,452||2,127|
|Right of Use Asset, net||594||—|
|Long-term restricted cash||1,379||279|
|Liabilities and stockholders’ equity (deficit)|
|Loan payable, current portion||20,927||21,385|
|Lease liability, current portion||734||—|
|Deferred revenue, current portion||1,023||959|
|Total current liabilities||29,478||35,144|
|Deferred rent and lease incentive||—||34|
|Deferred revenue, net of current portion||14,981||13,818|
|Other long‑term liabilities||—||904|
|Stockholders’ equity (deficit):|
|Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively||—||—|
|Common stock, $0.0001 par value; 200,000,000 shares authorized; 48,196,387 and 22,471,776 shares issued and outstanding as of September 30, 2019 and December 31, 2018, respectively||5||3|
|Additional paid-in capital||320,478||279,539|
|Accumulated other comprehensive loss||(4,533||)||(4,557||)|
|Total stockholders’ equity (deficit)||(4,915||)||(5,418||)|
|Total liabilities and stockholders’ equity (deficit)||$||39,544||$||44,482|
Consolidated Statements of Operations and Comprehensive Loss
(Amounts in thousands, except share and per share data)
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Grant and collaboration revenue||$||—||$||—||$||23||$||—|
|Research and development||8,104||11,885||27,591||37,431|
|General and administrative||3,690||4,056||12,317||13,092|
|Total operating expenses||11,794||15,941||39,908||50,523|
|Loss from operations||(11,794||)||(15,941||)||(39,885||)||(50,523||)|
|Foreign currency transaction (loss), net||7||26||(33||)||97|
|Other (expense), net||(3||)||3||(67||)||11|
|Other comprehensive loss:|
|Foreign currency translation adjustment||(5||)||(42||)||24||(113||)|
|Unrealized gain on securities||(3||)||1||—||16|
|Total comprehensive loss||$||(12,002||)||$||(16,042||)||$||(40,438||)||$||(50,782||)|
|Net loss per share:|
|Basic and diluted||$||(0.26||)||$||(0.71||)||$||(0.94||)||$||(2.27||)|
|Weighted average common shares outstanding:|
|Basic and diluted||46,407,846||22,403,954||43,265,909||22,368,574|
Source: Selecta Biosciences, Inc.