Receptos Provides Business Update and Reports First Quarter 2015 Financial Results
05 Maggio 2015 - 10:01PM
- Positive Phase 2 induction and
maintenance results for TOUCHSTONE trial of ozanimod (formerly
RPC1063) in Ulcerative Colitis (UC) support broad development
program in UC, Crohn's Disease - - Ongoing
clinical trials enrolling on schedule - - Well
capitalized, with over $640 million in cash and investments as of
March 31, 2015 - - Conference Call Today
at 5:00 p.m. Eastern Time -
Receptos, Inc. (Nasdaq:RCPT), a biopharmaceutical company
developing therapeutic candidates for the treatment of immune and
metabolic diseases, today provided development program updates
and reviewed financial results for the first quarter
ended March 31, 2015.
"With the recently announced positive maintenance results of the
TOUCHSTONE Phase 2 trial of ozanimod, we are moving forward
expeditiously with a full Phase 3 program in ulcerative colitis as
well as a Phase 2 trial in Crohn's disease," said Faheem Hasnain,
Chief Executive Officer of Receptos. "We have a strong balance
sheet and full ownership of the program, and have confidence in our
ability to execute on the development plan for ozanimod in
relapsing multiple sclerosis and inflammatory bowel
disease. We are also excited about the progress we are making
with RPC4046 in eosinophilic esophagitis and our pre-clinical oral
GLP-1 program."
Development Program Updates
Ozanimod (formerly RPC1063) in Relapsing Multiple Sclerosis
(RMS)
- In the first quarter of 2015, Receptos reported that it has
completed enrollment in the RADIANCE Phase 3 trial of ozanimod in
RMS. Receptos is also conducting the SUNBEAM Phase 3 trial of
ozanimod in RMS. Each trials is a randomized, double-blind
study designed to compare 0.5 mg and 1.0 mg of ozanimod against
Avonex® (interferon beta-1a) in approximately 1,200 patients with
RMS. The primary objectives of the RADIANCE and SUNBEAM trials
are to assess whether ozanimod is superior to Avonex® in
reducing the annualized relapse rate in patients after two years of
therapy and one year of therapy, respectively. Both Phase 3
trials are being conducted under Special Protocol Assessment (SPA)
agreements with the FDA.
Ozanimod in Ulcerative Colitis (UC)
- Receptos reported positive results for the induction and
maintenance periods of the TOUCHSTONE Phase 2 trial of ozanimod in
patients with moderately-to-severely active UC. The study met
all efficacy endpoints with statistical significance for patients
on the 1.0 mg dose after 8 weeks of treatment (induction) and 32
weeks of treatment (maintenance). Safety data were consistent
with the favorable profile observed in the Phase 2 trial in
RMS. Detailed induction data were reviewed at an oral podium
presentation at the annual meeting of ECCO, the European Crohn's
and Colitis Organization, and detailed maintenance data are
expected to be reviewed at a major medical meeting in the coming
months. Receptos has also been notified that it has been
granted an oral presentation during the plenary session at the
Digestive Disease Week meeting in May 2015.
- Based on the positive results from the TOUCHSTONE trial, the
Company plans to initiate a Phase 3 program in UC and Phase 2
program in Crohn's disease (CD) in 2015.
RPC4046 in Eosinophilic Esophagitis (EoE)
- Receptos is enrolling patients into the Phase 2 HEROES trial of
RPC4046, Receptos' development candidate for the treatment of
EoE. RPC4046 has been granted Orphan Drug Designation for the
treatment of EoE, a GI-related immunological indication with high
unmet need. RPC4046 is a humanized monoclonal antibody directed
against interleukin-13 (IL-13), a target which has been validated
in other related allergic indications. The trial is expected
to be completed in 1H 2016.
Oral GLP-1 Receptor Positive Allosteric Modulator Program
- Receptos is pursuing a research program for glucagon-like
peptide-1 receptor (GLP-1R) small molecule, positive allosteric
modulators (PAMs) for the treatment of Type 2
diabetes. Internally developed, orally administered lead
compounds have shown single agent glucose lowering and weight loss
effects in a diabetic disease model, as well as activity that is
synergistic with metformin in combination studies. Receptos
expects to identify a lead candidate in 2015 and to subsequently
initiate IND-enabling studies.
Upcoming milestones
- Q2 2015: Presentation at Digestive Disease Week (DDW)
meeting for TOUCHSTONE Phase 2 trial of ozanimod in patients with
moderately-to-severely active UC
- 2H 2015: Detailed results of maintenance portion of
TOUCHSTONE Phase 2 trial of ozanimod in patients with
moderately-to-severely active UC
- 1H 2016: Top-line results of Phase 2 HEROES trial of
RPC4046, Receptos' development candidate for EoE
- 2H 2016: Top-line results of Phase 2 trial of ozanimod in
patients with CD
Financial highlights for the three months
ended March 31, 2015
First quarter 2015 financial results
- Total revenues for the first quarter of 2015 were $0, compared
to $1.4 million for the first quarter of 2014. Revenue during
the first quarter of 2014 consisted primarily of amortization of
upfront fees and milestone payments and R&D funding received
from Ono Pharmaceutical Co., Ltd ("Ono"). The lack of revenues
in the first quarter of 2015 reflects the completed amortization
associated with a technology transfer milestone payment. The
Company does not have any active collaborations, however it is
eligible to receive potential future milestone payments under its
agreement with Ono.
- Total operating expenses for the first quarter of 2015
were $41.4 million, compared to $22.8
million for the first quarter of 2014.
- Research and development ("R&D") expenses were $36.0
million for the first quarter of 2015 compared to $20.0 million for
the first quarter of 2014. The increase in R&D costs is
primarily related to increased external costs related to the
Company's clinical development programs as well as increased
personnel costs related to R&D staffing increases over the past
12 months.
- General and administrative ("G&A") expenses were $5.4
million for the first quarter of 2015, compared to $2.8 million for
the first quarter of 2014. The increase in G&A expenses
is primarily related to the expansion of the Company's operating
activities and is comprised of an increase in personnel costs
related to additional headcount, additional stock-based
compensation expense, and additional expenditures on outside
services, including consulting costs, legal and accounting fees,
market research and insurance.
- Net loss attributable to common shareholders was $40.3 million,
or $1.29 per share, for the first quarter of 2015, compared to
$21.5 million, or $1.01 per share, for the first quarter of
2014. Net loss for the first quarter of 2015 included
stock-based compensation expense of $3.8 million, compared to $1.8
million for the first quarter of 2014.
- Receptos had $644.6 million in cash, cash equivalents
and short term investments and approximately 33.0 million shares of
common stock outstanding on a fully diluted basis as of March 31,
2015.
Conference Call Today at 5:00 p.m. Eastern
Time (2:00 p.m. Pacific Time)
The Receptos management team will host a teleconference and
webcast to discuss the first quarter 2015 financial results and
recent business highlights. The live call may be accessed by phone
by calling (866) 757-6808 (domestic) or (760) 536-5211
(international), participant code 27905354. The webcast can be
accessed live on the Investor Relations section of the Receptos
website at www.receptos.com and will be archived for 14 days
following the call. A replay of the call will be available by phone
by calling (855) 859-2056, participant code 27905354.
About Receptos
Receptos is a biopharmaceutical company developing
therapeutic candidates for the treatment of immune and metabolic
diseases. The Company's lead program, ozanimod, is a sphingosine
1-phosphate 1 and 5 receptor small molecule modulator in
development for immune indications including RMS and
IBD. Patents supporting ozanimod were exclusively licensed to
Receptos from The Scripps Research
Institute (TSRI). The Company is also developing RPC4046,
an anti-interleukin-13 (IL-13) antibody for eosinophilic
esophagitis (EoE), an allergic/immune-mediated orphan disease, as
well as pipeline, pre-clinical stage assets.
Forward-Looking Statements
Statements contained in this release, other than statements of
historical fact, constitute "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of
1995. The words "expects," "believes," "anticipates," "may,"
"intends," "plans," "potential" and similar expressions are
intended to identify forward-looking statements. These
forward-looking statements do not constitute guarantees of future
performance. Investors are cautioned that forward-looking
statements, including without limitation statements regarding the
sufficiency of the Company's financial resources over future
periods, the ability of the Company to undertake certain
development activities (such as clinical trial enrollment and the
conduct of clinical trials) and accomplish certain development
goals (such as the completion of clinical trials and availability
of clinical trial results), and the safety, efficacy, projected
development timeline and therapeutic and commercial potential for
ozanimod (RPC1063), RPC 4046 and the GLP-1 positive allosteric
modulator program, constitute forward-looking statements. Such
forward-looking statements are subject to a number of risks and
uncertainties that could cause actual results to differ materially
from those anticipated. These forward-looking statements are
based upon the Company's current expectations and involve
assumptions that may never materialize or may prove to be
incorrect. Actual results and the timing of events could
differ materially from those anticipated in such forward-looking
statements as a result of various risks and uncertainties, which
include without limitation risks associated with the process of
discovering, developing and commercializing drug candidates that
are safe and effective for use as human therapeutics. These
and other risks regarding the Company's financial position and
research and development programs are described in detail in the
Company's SEC filings, including the Company's Annual Report on
Form 10-K for the year ended December 31, 2014. All
forward-looking statements contained in this release speak only as
of the date on which they were first made by the Company, and the
Company undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after such
date.
RECEPTOS,
INC. |
CONSOLIDATED FINANCIAL
RESULTS |
(In thousands, except per share
amounts) |
|
|
|
Three months
ended March 31, |
|
2015 |
2014 |
|
|
|
Collaborative
revenue |
$ -- |
$ 1,350 |
Operating expenses: |
|
|
Research and development |
36,042 |
20,007 |
General and administrative |
5,386 |
2,759 |
|
|
|
Total operating expenses |
41,428 |
22,766 |
|
|
|
Loss from
operations |
(41,428) |
(21,416) |
|
|
|
Other income (expense) |
301 |
(84) |
Foreign currency gain |
786 |
-- |
|
|
|
Net loss attributable to common
stockholders |
$ (40,341) |
$ (21,500) |
|
|
|
Net loss per common share, basic and
diluted |
$ (1.29) |
$ (1.01) |
|
|
|
Shares used to compute net loss per common
share, basic and diluted |
31,337 |
21,195 |
|
|
|
RECEPTOS, INC. |
|
|
CONSOLIDATED BALANCE SHEET
DATA |
|
|
(IN THOUSANDS) |
|
|
|
As of March 31, |
As of December
31, |
|
2015 |
2014 |
|
|
|
Cash, cash equivalents and short-term
investments |
644,569 |
671,929 |
Working capital |
611,093 |
647,012 |
Total assets |
661,425 |
678,007 |
Total liabilities |
47,346 |
28,520 |
Common stock and additional paid-in
capital |
865,041 |
860,415 |
Total stockholders' equity |
614,079 |
649,487 |
CONTACT: Media and Investor Contact:
Graham K. Cooper
Chief Financial Officer, Receptos
(858) 652-5708
gcooper@receptos.com
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