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Selecta Biosciences Reports Second Quarter 2019 Financial Results and Provides Corporate Update
- New strategic partnership with gene therapy leader, AskBio, to jointly develop next-generation AAV-based gene therapies to address the unmet medical need for repeat dosing in patients with rare and orphan genetic diseases -
- Patient enrollment ongoing in COMPARE trial evaluating efficacy and safety of SEL-212 vs. KRYSTEXXA® in patients with chronic refractory gout; interim data expected in 4Q19 -
- Company to host conference call today at 8:30 a.m. ET -
“Our gene therapy program has gained a lot of momentum, most notably with our new strategic partnership with AskBio, which will combine our ImmTOR platform technology with AskBio’s AAV technology and know-how. We believe this partnership will allow us to develop a robust pipeline of products that can potentially be re-dosed and offer patients a new treatment paradigm in areas of high unmet need,” said
Recent Highlights and Anticipated Upcoming Milestones
Chronic Refractory Gout Program:
- COMPARE Clinical Trial of SEL-212 vs. Krystexxa Enrolling Patients: In
March 2019, Selectainitiated a six-month head-to-head clinical trial (COMPARE) designed to evaluate the superiority of its lead product candidate, SEL-212 (ImmTOR + Pegadricase), compared to Krystexxa, the current U.S. Food and Drug Administration( FDA)-approved uricase therapy, in adult patients with chronic refractory gout. The COMPARE trial, which is currently enrolling patients, is expected to enroll 150 patients, and the primary endpoint is the maintenance of serum uric acid (sUA) levels of <6mg/dL at six months. An interim data analysis is expected in the fourth quarter of 2019 with a full statistical superiority analysis expected in the second quarter of 2020.
AAV Gene Therapy Program:
New 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 adeno-associated virus (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.
- Advancing Collaboration with
CureCN Consortium: Under a collaboration with the European consortium, CureCN, for an ImmTOR+AAV gene therapy combination product candidate in Crigler-Najjar Syndrome, Selectaexpects CureCN to obtain scientific advice from the German drug regulatory authority in the second half of 2019.
- Strengthened Management Team:
Selectaannounced the appointment of Alison Schecter, M.D., as Chief Medical Officer in July 2019. Dr. Schecter has over 20 years of combined drug development, strategic management and practical clinical experience in academia and industry and joins Selectafrom Sanofi, where she was the Global Project Head, Rare Diseases, and was responsible for leading the Niemann-Pick Disease (ASMD) project.
- Expanded Board of Directors:
Selectaannounced the addition of Scott D. Myersto its Board of Directors, in June 2019. Mr. Myers has more than 20 years of leadership experience in the biopharmaceutical industry and currently serves as Chief Executive Officer and Chairman of the Board of Rainier Therapeutics.
Second Quarter 2019 Financial Results:
- Revenue: For the second quarter ended
June 30, 2019, the company recognized less than $0.1 millionof revenue under its collaboration agreement with Spark.
- Research and Development Expenses: Research and development expenses for the second quarter ended
June 30, 2019were $12.1 million, which compares with $14.4 millionfor the second quarter of 2018. Research and development expenses decreased by $2.3 million, or 16%, as compared to the same period in 2018. The decrease reflects the reduced salaries and benefits as a result of the company’s headcount reduction at the beginning of fiscal 2019. There were further cost reductions related to discontinued programs. These cost reductions were offset by the timing of costs incurred for both the company’s Phase 2 and Phase 3 clinical programs for SEL-212.
- General and Administrative Expenses: General and administrative expenses for the second quarter ended
June 30, 2019were $4.1 million, which compares with $4.4 millionfor the second quarter of 2018. General and administrative expenses decreased by $0.3 million, or 6%, as compared to the same period in 2018. The reduction in costs was primarily the result of reduced legal fees, offset by an increase in professional fees.
- Net Loss: For the second quarter ended
June 30, 2019, Selectareported a net loss of $16.4 million, or $0.37per share, compared to a net loss of $18.8 million, or $0.84per share, for the same period in 2018.
- Cash Position:
Selectahad $42.0 millionin cash, cash equivalents, restricted cash and short-term investments as of June 30, 2019, which compares to cash, cash equivalents, restricted cash and short-term investments of $48.7 millionas of March 31, 2019.
Conference Call and Webcast Reminder
About Selecta Biosciences, Inc.
Any statements in this press release about the future expectations, plans and prospects of
Consolidated Balance Sheets
(Amounts in thousands, except share data and par value)
|June 30, 2019||December 31, 2018|
|Cash, cash equivalents, and restricted cash||$||30,479||$||37,403|
|Short-term deposits and investments||11,480||—|
|Prepaid expenses and other current assets||2,490||4,673|
|Total current assets||44,449||42,076|
|Property and equipment, net||1,620||2,127|
|Right of Use Asset, net||878||—|
|Restricted cash and other assets||—||279|
|Liabilities and stockholders’ equity|
|Loan payable, current portion||21,548||21,385|
|Lease Liability, current portion||1,085||—|
|Deferred revenue, current portion||1,023||959|
|Total current liabilities||31,908||35,144|
|Deferred rent and lease incentive||—||34|
|Deferred revenue, net of current portion||14,983||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 June 30, 2019 and December 31, 2018, respectively||—||—|
|Common stock, $0.0001 par value; 200,000,000 shares authorized; 44,952,951 and 22,471,776 shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively||5||3|
|Additional paid-in capital||313,447||279,539|
|Accumulated other comprehensive loss||(4,525||)||(4,557||)|
|Total stockholders’ equity (deficit)||56||(5,418||)|
|Total liabilities and stockholders’ equity (deficit)||$||46,947||$||44,482|
Consolidated Statements of Operations and Comprehensive Loss
(Amounts in thousands, except share and per share data)
|Three Months Ended June 30,||Six Months Ended June 30,|
|Grant and collaboration revenue||$||13||$||—||$||23||$||—|
|Research and development||12,134||14,407||19,487||25,546|
|General and administrative||4,114||4,362||8,627||9,036|
|Total operating expenses||16,248||18,769||28,114||34,582|
|Loss from operations||(16,235||)||(18,769||)||(28,091||)||(34,582||)|
|Foreign currency transaction (loss), net||(10||)||84||(40||)||71|
|Other (expense), net||5||8||(64||)||8|
|Other comprehensive loss:|
|Foreign currency translation adjustment||7||(90||)||29||(71||)|
|Unrealized gain on securities||1||12||3||15|
|Total comprehensive loss||$||(16,386||)||$||(18,874||)||$||(28,436||)||$||(34,740||)|
|Net loss per share:|
|Basic and diluted||$||(0.37||)||$||(0.84||)||$||(0.68||)||$||(1.55||)|
|Weighted average common shares outstanding:|
|Basic and diluted||44,855,083||22,355,603||41,668,902||22,350,591|
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Source: Selecta Biosciences, Inc.