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Selecta Biosciences Reports Second Quarter 2020 Financial Results and Provides Corporate Updates
- Closed strategic licensing agreement with Sobi for SEL-212 for
$100 millionin initial payments and up to $630 millionin potential milestones, and tiered double-digit royalties
- Entered into research license and option agreement with Sarepta for the use of the ImmTOR™ immune tolerance platform in Sarepta’s gene therapy programs in certain neuromuscular diseases
- Gene therapy program in MMA in collaboration with AskBio on track to enter the clinic in the first half of 2021; preliminary data expected in the second half of 2021
- Phase 3 clinical program of SEL-212 to commence with Sobi in Q3 2020; on track to report topline data from ongoing head-to-head COMPARE trial in Q3 2020
- Cash runway into the first quarter of 2023
- Company to host conference call today at
8:30 a.m. ET
“This is a transformational time for
Recent Highlights and Anticipated Upcoming Milestones:
- Closed Strategic Licensing Agreement with Sobi for SEL-212, the Company’s Phase 3-ready Novel Treatment for Chronic Refractory Gout: The Company announced the closing of a strategic licensing agreement with Sobi for SEL-212, the Company’s lead product candidate leveraging the ImmTOR immune tolerance platform. Sobi assumes responsibility for all development, regulatory, and commercial activities, and expenses in all markets outside
China, while Selectawill run the Phase 3 study on behalf of Sobi, at Sobi’s expense. Selectawill also maintain manufacturing of ImmTOR, for which Sobi will reimburse Selectafor activities relating to SEL-212. The initial payments to Selectatotal $100 million. Sobi must pay $75 millionin cash as an upfront license fee within 45 days of the effective date and has paid $25 millionin cash in a private placement of Selectacommon stock at $4.62per share. Selectais also eligible to receive potential development, regulatory, and commercial milestone payments of up to $630 million, and tiered double-digit royalties on net sales.
- Entered into Research License and Option Agreement with Sarepta for the Use of ImmTOR in Certain Neuromuscular Diseases:
Selectaand Sarepta reached an agreement which provides Sarepta with the option to license the rights to develop and commercialize the ImmTOR platform for use in select neuromuscular diseases; Duchenne muscular dystrophy (DMD) and certain limb-girdle muscular dystrophies (LGMDs). Sarepta will evaluate its investigational gene therapies in combination with ImmTOR to mitigate the formation of neutralizing antibodies. Sarepta has made an initial payment to Selecta, and Selectais eligible to receive certain pre-clinical milestone fees.
- Two Key Clinical Milestones for SEL-212:
Selectaand Sobi anticipate initiating the Phase 3 clinical program in the third quarter of 2020. Selectawill take the lead running the Phase 3 program, at Sobi’s expense. The Phase 3 clinical program will consist of two double blinded, placebo-controlled trials of SEL-212. Each trial is expected to enroll 105 patients and have 35 patients receiving 0.1 mg/kg of ImmTOR and 0.2 mg/kg of pegadricase, 35 patients receiving 0.15 mg/kg of ImmTOR and 0.2 mg/kg of pegadricase, and 35 patients receiving placebo. The primary endpoint of the Phase 3 clinical trials is the maintenance of serum uric acid (SUA) levels of <6mg/dL at six months. One of the trials will have a six-month extension. In addition, the Company expects topline results from the Phase 2 COMPARE clinical trial in Q3 2020. This head-to-head study of a once-monthly dose of SEL-212 (ImmTOR + pegadricase) compared to biweekly doses of pegloticase is expected to read out on schedule. The primary endpoint of the COMPARE trial is the maintenance of serum uric acid (SUA) levels of <6mg/dL at three and six months.
- Timeline for Gene Therapy and Autoimmune Diseases Programs Confirmed: The Company’s gene therapy program in methylmalonic acidemia, or MMA, in collaboration with AskBio, is expected to enter the clinic in the first half of 2021, with preliminary data expected in 2H 2021. In addition,
Selectaintends to submit its Investigational New Drug Application (IND) for its autoimmune disease program in 2021. The first indication will be IgA nephropathy, a kidney disease that occurs when an antibody called immunoglobulin A (IgA) accumulates in the kidneys. The second indication is expected to be primary biliary cholangitis, or PBC, an autoimmune disease that causes progressive destruction of the bile ducts. Both diseases have well-defined target antigens, significant unmet medical need, and are well suited to the application of Selecta’s ImmTOR immune tolerance platform.
Peter G. Traber, MD, to the Position of Chief Medical Officer: Dr. Traber, who has been serving in the same position in an interim capacity, joined the Company full-time as of August 1, 2020. Dr. Traberhas a broad range of experience in large pharma, biotech, and academia, and will oversee medical affairs, program management, and all aspects of clinical development and strategy, as well as provide scientific and clinical guidance for potential business development initiatives.
Second Quarter 2020 Financial Results:
- Cash Position:
Selectahad $61.4 millionin cash, cash equivalents, and restricted cash as of June 30, 2020, which compares to cash, cash equivalents, and restricted cash of $91.6 millionas of December 31, 2019. Selectabelieves its available cash, cash equivalents, and restricted cash as of June 30, 2020, together with the $25 millionpayment received from Sobi under the Sobi Private Placement in July and the expected payment from Sobi of $75 millionunder the Sobi License, which is due 45 days after the effective date, will enable Selectato fund operating expenses and capital expenditure requirements into the first quarter of 2023.
- Net cash used in operating activities was
$23.5 millionfor the six months ended June 30, 2020, as compared to $27.4 millionfor the same period in 2019.
- Net cash used in operating activities was
- Research and Development Expenses: Research and development expenses for the second quarter 2020 were
$10.7 million, which compares with $12.1 millionfor the same period in 2019. The decrease in costs was primarily the result of reduced expense for the Phase 2 COMPARE trial for SEL-212 offset by increases for the gene therapy program in collaboration with AskBio, and salaries and benefits.
- General and Administrative Expenses: General and administrative expenses for the second quarter 2020 were
$5.6 million, which compares with $4.1 millionfor the same period in 2019. The increase in costs was the result of expenses incurred for salaries, legal and professional fees offset by decreased travel expense.
- Net Loss: For the second quarter 2020,
Selectareported a net loss of $24.1 million, or $0.25per share, compared to a net loss of $16.4 million, or $0.37per share, for the same period in 2019.
Conference Call and Webcast Reminder:
Any statements in this press release about the future expectations, plans and prospects of Selecta Biosciences, Inc. (“the company”), including without limitation, the company’s actions regarding the monitoring and assessment of COVID-19 on the company’s operations, clinical trials and manufacturing, Sarepta’s plans to evaluate its gene therapies in combination with the company’s ImmTOR technology, the possibility of Sarepta exercising an option to enter into a commercial license agreement, Sarepta’s achievement of any milestones that would trigger payment(s) to
Consolidated Balance Sheets
(Amounts in thousands, except share data and par value)
|Cash and cash equivalents||$||59,730||$||89,893|
|Prepaid expenses and other current assets||1,044||1,495|
|Total current assets||61,052||96,667|
|Property and equipment, net||1,301||1,222|
|Right-of-use asset, net||11,474||301|
|Long-term restricted cash||1,379||1,379|
|Liabilities and stockholders’ equity (deficit)|
|Total current liabilities||22,510||34,943|
|Loan payable, net of current portion||6,449||—|
|Stockholders’ equity (deficit):|
|Additional paid-in capital||370,944||348,664|
|Accumulated other comprehensive loss||(4,552||)||(4,523||)|
|Total stockholders’ equity (deficit)||(13,052||)||8,397|
|Total liabilities and stockholders’ equity (deficit)||$||75,206||$||99,569|
Consolidated Statements of Operations and Comprehensive Loss
(Amounts in thousands, except share data and per share data)
|Three Months Ended
||Six Months Ended
|Grant and collaboration revenue||$||—||$||13||$||—||$||23|
|Research and development||10,730||12,134||25,454||19,487|
|General and administrative||5,637||4,114||9,735||8,627|
|Total operating expenses||16,367||16,248||35,189||28,114|
|Loss from operations||(16,367||)||(16,235||)||(35,189||)||(28,091||)|
|Foreign currency transaction (loss), net||(42||)||(10||)||40||(40||)|
|Change in fair value of warrant liabilities||(7,539||)||—||(8,385||)||—|
|Other (expense), net||59||5||58||(64||)|
|Other comprehensive loss:|
|Foreign currency translation adjustment||31||7||(29||)||29|
|Unrealized gain on securities||—||1||—||3|
|Total comprehensive loss||$||(24,050||)||$||(16,386||)||$||(43,730||)||$||(28,436||)|
|Net loss per share:|
|Basic and diluted||$||(0.25||)||$||(0.37||)||$||(0.46||)||$||(0.68||)|
|Weighted average common shares outstanding:|
|Basic and diluted||96,785,915||44,855,083||95,754,714||41,668,902|
Source: Selecta Biosciences, Inc.