Selecta Biosciences, Inc. (Nasdaq: SELB), a clinical-stage
biotechnology company focused on unlocking the full potential of
biologic therapies based on its immune tolerance platform
technology, ImmTOR, today reported financial results for the first
quarter ended March 31, 2019 and provided a corporate update.
“We are excited to be enrolling patients in the COMPARE trial
and look forward to the opportunity to differentiate SEL-212
compared to the current FDA-approved uricase therapy in adult
patients with chronic refractory gout,” said Carsten Brunn, Ph.D.,
President and CEO of Selecta. “As we continue to develop our ImmTOR
platform for rare and serious diseases, we are pleased by the
advancements in our gene therapy program, most recently with the
presentation of new preclinical data at ASGCT highlighting how the
co-administration of our technology with AAV-based vectors
suppressed the immune response to the vector, potentially enabling
re-dosing to provide sustained therapeutic efficacy over time.”
Recent Highlights and Anticipated Upcoming
Milestones
SEL-212 (ImmTOR + Pegadricase) for the Treatment of
Chronic Refractory Gout:
- Initiated 6-Month COMPARE Clinical Trial of SEL-212 vs.
Krystexxa: In March 2019, Selecta initiated 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 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 six-month data readout is projected in the fourth quarter
of 2019 with a full statistical superiority data analysis readout
expected in the first quarter of 2020.
- Initiation of Phase 3 Clinical Trial of SEL-212
Anticipated in Q4 19: The interim results of the COMPARE
trial, which are anticipated in the fourth quarter of 2019, are
expected to inform the design of the Phase 3 clinical trial of
SEL-212, which the company plans to initiate in the fourth quarter
of 2019.
ImmTOR + AAV Gene Therapy Program:
- Presented New Preclinical Data at the American Society
of Gene & Cell Therapy (ASGCT) 22nd Annual Meeting: In
April 2019, Selecta scientists and collaborators from the National
Institutes of Health (NIH) and the International Centre for Genetic
Engineering and Biotechnology (ICGEB) gave five presentations of
new preclinical data demonstrating the potential for the re-dosing
of adeno-associated virus (AAV)-based gene therapy vectors when
administered in combination with its ImmTOR (SVP-Rapamycin) at the
ASGCT Annual Meeting in Washington, DC.
- Advancing Collaboration with CureCN
Consortium: Our collaboration with the European
consortium, CureCN, for an ImmTOR+AAV gene therapy combination
product candidate in Crigler-Najjar Syndrome continues to
progress.
Corporate Updates:
- Strengthened Management and Clinical
Teams: In March 2019, Selecta appointed Elona Kogan, J.D.
as General Counsel and Secretary. She was most recently General
Counsel and head of Government Relations at ARIAD Pharmaceuticals,
Inc., a rare disease oncology company, where she was a key
executive through the acquisition of the company by Takeda
Pharmaceuticals Company Limited. Also, in March, Selecta appointed
Horacio Plotkin, MD, FAAP as the new Head of Clinical Development.
He brings 20 years of clinical pediatric experience and 12 years in
biotech and was most recently Head of Clinical Development, Rare
Diseases at Moderna Therapeutics.
First Quarter 2019 Financial Results:
- Revenue: For the first quarter of 2019, the
company recognized less than $0.1 million of revenue for a shipment
under its collaboration agreement with Spark, which compares to
zero revenue recognized for the first quarter of 2018.
- Research and Development Expenses: Research
and development expenses for the first quarter of 2019 were $7.4
million, which compares with $11.1 million for the first quarter of
2018. The decrease was driven by reduced salaries and
benefits as a result of the company’s headcount reduction at the
beginning of the first quarter of 2019 combined with expenses
incurred for both the Phase 2 and Phase 3 clinical programs for
SEL-212.
- General and Administrative Expenses: General
and administrative expenses for the first quarter of 2019 were $4.5
million, which compares with $4.7 million for the first quarter of
2018. The reduction in costs was primarily the result of reduced
consulting fees.
- Net Loss: For the first quarter of 2019,
Selecta reported a net loss of $12.1 million, or $0.31 per share,
compared to a net loss of $15.9 million, or $0.71 per share, for
the same period in 2018.
- Cash Position: Selecta had $48.7 million in
cash, cash equivalents, restricted cash and short-term investments
as of March 31, 2019, which compares to cash, cash equivalents and
restricted cash of $37.7 million at December 31, 2018.
Financial Outlook:
Selecta believes its available cash, cash equivalents and
restricted cash will be sufficient to meet its operating
requirements into the first quarter of 2020.
Conference Call and Webcast ReminderSelecta
management will host a conference call at 8:30 a.m. ET today to
provide a corporate update and review the company’s first quarter
2019 financial results. Investors and the public can access a live
and archived webcast of this call via the Investors & Media
section of the company’s website, http://selectabio.com.
Individuals may also participate in the live call via telephone by
dialing (844) 845-4170 (domestic) or (412) 717-9621 (international)
and may access a teleconference replay for one week by dialing
(877) 344-7529 (domestic) or (412) 317-0088 (international) and
using confirmation code 10127202.
About Selecta Biosciences, Inc.Selecta
Biosciences, Inc. is a clinical-stage biotechnology company focused
on unlocking the full potential of biologic therapies based on its
immune tolerance technology (ImmTOR) platform. Selecta plans to
combine ImmTOR with a range of biologic therapies for rare and
serious diseases that require new treatment options due to high
immunogenicity. The company’s current proprietary pipeline includes
ImmTOR-powered therapeutic enzyme and gene therapy product
candidates. SEL-212, the company’s lead product candidate, is being
developed to treat chronic refractory gout patients and resolve
their debilitating symptoms, including flares and gouty arthritis.
Selecta’s proprietary gene therapy product candidates are in
preclinical development for certain rare inborn errors of
metabolism and incorporate ImmTOR with the goal of addressing
barriers to repeat administration. Selecta is based in Watertown,
Massachusetts. For more information, please visit
http://selectabio.com.
Forward-Looking Statements Any statements in
this press release about the future expectations, plans and
prospects of Selecta Biosciences, Inc. (“the company”), including
without limitation, statements regarding the progress of the
clinical development of SEL-212, expectations surrounding the
enrollment and design of the Phase 2 head-to-head (COMPARE)
clinical trial comparing SEL-212 and Krystexxa, timing of related
data readouts and the ability of the COMPARE results to inform the
planned Phase 3 clinical trial of SEL-212, the anticipated timing
of the planned Phase 3 clinical trial, whether the head-to-head
trial with Krystexxa will demonstrate superiority, the potential of
ImmTOR to enable re-dosing of AAV gene therapy and the anticipated
timing of preclinical toxicology studies in collaboration with
CureCN and initiation of a clinical trial related thereto, the
potential of SEL-212 to fulfill unmet needs in chronic refractory
gout patients including sustained sUA reduction, reduced flares,
and once monthly dosing, the company’s commercial plans, the
ability of the company’s ImmTOR platform, including SEL-212, to
unlock the full potential of biologic therapies, the potential of
SEL-212 to treat chronic refractory gout patients and resolve their
debilitating symptoms, the potential treatment applications for
product candidates utilizing the ImmTOR platform in areas such as
enzyme therapy and gene therapy, the company’s plan to apply its
ImmTOR technology platform to a range of biologics for rare and
serious diseases, the potential of the company’s two gene therapy
product candidates to enable repeat administration, the Company’s
ability to re-dose patients and the potential of ImmTOR to allow
for re-dosing, the potential of the ImmTOR technology platform
generally and the company’s ability to grow its strategic
partnerships, the sufficiency of the company’s cash, cash
equivalents and short-term investments, and other statements
containing the words “anticipate,” “believe,” “continue,” “could,”
“estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,”
“potential,” “predict,” “project,” “should,” “target,” “would,” and
similar expressions, constitute forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. Actual results may differ materially from those indicated by
such forward-looking statements as a result of various important
factors, including, but not limited to, the following: the
uncertainties inherent in the initiation, completion and cost of
clinical trials including their uncertain outcomes, the
availability and timing of data from ongoing and future clinical
trials and the results of such trials, whether preliminary results
from a particular clinical trial will be predictive of the final
results of that trial or whether results of early clinical trials
will be indicative of the results of later clinical trials, the
unproven approach of the company’s ImmTOR technology, potential
delays in enrollment of patients, undesirable side effects of the
company’s product candidates, its reliance on third parties to
manufacture its product candidates and to conduct its clinical
trials, the company’s inability to maintain its existing or future
collaborations, licenses or contractual relationships, its
inability to protect its proprietary technology and intellectual
property, potential delays in regulatory approvals, the
availability of funding sufficient for its foreseeable and
unforeseeable operating expenses and capital expenditure
requirements, the company’s recurring losses from operations and
negative cash flows from operations raise substantial doubt
regarding its ability to continue as a going concern, substantial
fluctuation in the price of its common stock, and other important
factors discussed in the “Risk Factors” section of the company’s
Annual Report on Form 10-Q for the quarter ended March 31, 2019,
and in other filings that the company makes with the Securities and
Exchange Commission. In addition, any forward-looking statements
included in this press release represent the company’s views only
as of the date of its publication and should not be relied upon as
representing its views as of any subsequent date. The company
specifically disclaims any obligation to update any forward-looking
statements included in this press release.
Selecta Biosciences, Inc. and
Subsidiaries
Consolidated Balance Sheets
(Amounts in thousands, except share data
and par value)
|
|
March 31, 2019 |
|
December 31, 2018 |
|
|
(Unaudited) |
|
|
Assets |
|
|
|
|
Current
assets: |
|
|
|
|
Cash, cash equivalents, and restricted cash |
|
$ |
32,452 |
|
|
$ |
37,403 |
|
Short-term deposits and
investments |
|
16,244 |
|
|
— |
|
Prepaid expenses and other
current assets |
|
10,832 |
|
|
4,673 |
|
Total current assets |
|
59,528 |
|
|
42,076 |
|
Property and equipment, net |
|
1,799 |
|
|
2,127 |
|
Right of Use Asset, net |
|
1,155 |
|
|
— |
|
Restricted cash and other
assets |
|
— |
|
|
279 |
|
Total assets |
|
$ |
62,482 |
|
|
$ |
44,482 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts payable |
|
$ |
693 |
|
|
$ |
1,100 |
|
Accrued expenses |
|
8,500 |
|
|
11,700 |
|
Loan payable, current
portion |
|
21,466 |
|
|
21,385 |
|
Lease Liability, current
portion |
|
1,428 |
|
|
— |
|
Deferred revenue, current
portion |
|
959 |
|
|
959 |
|
Total current liabilities |
|
33,046 |
|
|
35,144 |
|
Non‑current liabilities: |
|
|
|
|
Deferred rent and lease
incentive |
|
— |
|
|
34 |
|
Deferred revenue, net of current
portion |
|
13,816 |
|
|
13,818 |
|
Other long‑term liabilities |
|
801 |
|
|
904 |
|
Total liabilities |
|
47,663 |
|
|
49,900 |
|
Stockholders’ equity
(deficit): |
|
|
|
|
Preferred stock, $0.0001 par
value; 10,000,000 shares authorized; no shares issued and
outstanding at March 31, 2019 and December 31, 2018,
respectively |
|
— |
|
|
— |
|
Common stock, $0.0001 par
value; 200,000,000 shares authorized; 44,788,025 and 22,471,776
shares issued and outstanding as of March 31, 2019 and December
31, 2018, respectively |
|
5 |
|
|
3 |
|
Additional paid-in capital |
|
311,824 |
|
|
279,539 |
|
Accumulated deficit |
|
(292,477 |
) |
|
(280,403 |
) |
Accumulated other comprehensive
loss |
|
(4,533 |
) |
|
(4,557 |
) |
Total stockholders’ equity
(deficit) |
|
14,819 |
|
|
(5,418 |
) |
Total liabilities and
stockholders’ equity |
|
$ |
62,482 |
|
|
$ |
44,482 |
|
Selecta Biosciences, Inc. and
Subsidiaries
Consolidated Statements of
Operations and Comprehensive Loss
(Amounts in thousands, except share and
per share data)
|
Three Months Ended March 31, |
|
2019 |
|
2018 |
|
(Unaudited) |
Grant and collaboration revenue |
$ |
10 |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
Research and development |
7,353 |
|
|
11,139 |
|
General and administrative |
4,513 |
|
|
4,674 |
|
Total operating expenses |
11,866 |
|
|
15,813 |
|
Loss from operations |
(11,856 |
) |
|
(15,813 |
) |
Investment income |
277 |
|
|
288 |
|
Foreign currency transaction
(loss), net |
(30 |
) |
|
(13 |
) |
Interest expense |
(396 |
) |
|
(350 |
) |
Other (expense), net |
(69 |
) |
|
— |
|
Net loss |
(12,074 |
) |
|
(15,888 |
) |
Other comprehensive loss: |
|
|
|
Foreign currency translation adjustment |
22 |
|
|
19 |
|
Unrealized gain on securities |
2 |
|
|
3 |
|
Total comprehensive loss |
$ |
(12,050 |
) |
|
$ |
(15,866 |
) |
|
|
|
|
Net loss per share: |
|
|
|
Basic and diluted |
$ |
(0.31 |
) |
|
$ |
(0.71 |
) |
Weighted average common shares
outstanding: |
|
|
|
Basic and diluted |
38,447,319 |
|
|
22,345,523 |
|
For Investors:Sarah McCabeStern Investor
Relations, Inc.+1-212-362-1200sarah@sternir.com
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