Receptos Reports Second Quarter 2013 Financial Results
08 August 2013 - 6:05AM
- Phase 2 trials of RPC1063 continue to
enroll patients globally -
- Company capitalized to complete current
Phase 2 trials -
- Additional Phase 1 results of RPC1063
to be presented at ECTRIMS -
- Conference Call Today at 5 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
announced financial results for the second quarter ended June 30,
2013.
"We continue to execute on our Phase 2 trials of RPC1063 in
relapsing multiple sclerosis and ulcerative colitis," said Faheem
Hasnain, Chief Executive Officer of Receptos. "As a result of our
successful IPO in the second quarter, we are now well capitalized
to drive these programs forward. We look forward to data next year
on both trials, as well as making progress with our pipeline
programs."
Development Program Updates
RPC1063 in Relapsing Multiple Sclerosis
- Receptos continues to enroll the Phase 2 portion of an
accelerated, randomized Phase 2/3 study (RADIANCE) for the
treatment of relapsing multiple sclerosis (RMS). The accelerated
design has been reviewed with the FDA and Receptos has received a
Special Protocol Assessment (SPA) agreement from the FDA on the
design for the planned Phase 3 portion of the Phase 2/3 study as
well as a second planned RMS Phase 3 study.
- The Company anticipates completing enrollment and conducting an
interim analysis of the Phase 2 portion of this study in the fourth
quarter of 2013, the results of which will inform any decision to
advance into Phase 3. Top-line results for this Phase 2 study
are anticipated in mid-2014. The primary objective of RADIANCE
is to demonstrate the superior clinical efficacy of RPC1063
compared to placebo as measured by a reduction in the cumulative
number of total gadolinium-enhancing lesions determined by MRI from
week 12 to week 24 of study treatment.
- The Company plans to review the results of its Phase 1 Thorough
QT/QTc study in a poster presentation at the annual meeting of the
European Committee for Treatment and Research in Multiple Sclerosis
(ECTRIMS) being held October 2-5, 2013 in Copenhagen,
Denmark. The study ruled out a relevant QTc effect for RPC1063
at both the therapeutic and the supra-therapeutic doses, and dose
titration appeared to attenuate the first dose heart rate
effects.
RPC1063 in Ulcerative Colitis
- Receptos continues to enroll a randomized Phase 2 study
(TOUCHSTONE) for the treatment of ulcerative colitis (UC), a
serious gastrointestinal disease. Top‑line results for this
Phase 2 study are anticipated in mid-2014. The primary
objective of TOUCHSTONE is to demonstrate superior clinical
efficacy of RPC1063 compared to placebo for the induction of
clinical remission in patients with moderately to severely active
UC.
- Two abstracts on RCP1063 were presented at the annual Digestive
Disease Week conference in May. They included data from nonclinical
studies and an earlier Phase 1 study in normal healthy volunteers
and highlighted the emerging favorable safety, pharmacokinetic and
pharmacodynamic profile for RPC1063.
RPC4046 in Eosiniphilic Esophagitis
- Receptos is in the planning stages of a Phase 2
proof‑of‑concept study in patients with active eosiniphilic
esophagitis (EoE), a GI-related immunological indication that has a
prevalence of under 200,000 patients in the U.S. and could qualify
for orphan designation. As part of the planned development
program for RPC4046, the Company intends to request a pre-IND
meeting with the FDA by the end of 2013 and subsequently submit an
IND in the first half of 2014, leading to the initiation of a
Phase 2 trial.
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 efficacy in a diabetic disease model as well as
activity that is synergistic with metformin in combination
studies. Receptos expects to select a lead compound by the end
of 2013 and complete IND-enabling studies in 2014.
Financial highlights for the three months
ended June 30, 2013
- Total revenues for the second quarter of 2013 were $1.2
million, compared to $1.7 million for the second quarter of
2012. Revenue during these periods consisted primarily of
amortization of up-front fees and milestone payments, which are
being recognized over the estimated period of performance, and
research and development funding received from our collaborative
arrangements.
- Total operating expenses for the second quarter of 2013
were $11.0 million, compared to $5.0
million for the second quarter of 2012.
- Research and development ("R&D") expenses were $9.4 million
for the second quarter of 2013 compared to $4.3 million for the
second quarter of 2012. R&D expenses consist primarily of
costs associated with the preclinical and clinical development of
our product candidates. The increase in R&D costs is primarily
related to increased Phase 2 trial activity and Phase 3 start up
costs for our Phase 2/3 trial of RPC1063 in RMS, and commencement
of the Phase 2 trial of RPC1063 in UC.
- General and administrative ("G&A") expenses were $1.6
million for the second quarter of 2013 compared to $0.8 million for
the second quarter of 2012. The increase in G&A costs is
primarily related to increased personnel costs, additional
stock-based compensation and additional expenditures on outside
services, including consulting costs, legal fees and
insurance.
- Receptos had $91.1 million in cash and cash
equivalents, debt of $4.8 million and approximately 18.3 million
shares of common stock outstanding as of June 30, 2013.
Conference Call Today at 5 p.m. Eastern
Time (2:00 p.m. Pacific Time)
The Receptos management team will host a teleconference and
webcast to discuss the second quarter 2013 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 14394984. 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 14394984.
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 capital position 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 availability of clinical trial results), and the
safety, efficacy, projected development timeline and therapeutic
and commercial potential for 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 Quarterly Reports on Form 10-Q and the Registration
Statement on Form S-1 which was declared effective on May 8,
2013. 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.
About Receptos
Receptos is a biopharmaceutical company developing therapeutic
candidates for the treatment of immune and metabolic diseases. The
Company's lead program, RPC1063, is a sphingosine 1-phosphate 1
receptor (S1P1R) small molecule modulator candidate for immune
indications, including relapsing multiple sclerosis (RMS) and
inflammatory bowel disease (IBD). The Company is also developing
RPC4046, an anti-interleukin-13 (IL-13) antibody for an
allergic/immune-mediated orphan disease, eosinophilic esophagitis
(EoE). Receptos has established expertise in high resolution
protein crystal structure determination, biology and drug discovery
for G-protein-coupled receptors (GPCRs).
RECEPTOS,
INC. |
Consolidated Financial
Results |
(In thousands, except per share
amounts) |
|
|
|
|
|
|
Three months
ended June 30, |
Six months ended
June 30, |
|
2012 |
2013 |
2012 |
2013 |
|
|
|
|
|
Collaborative revenue |
$1,690 |
$1,238 |
$3,015 |
$2,726 |
Operating expenses: |
|
|
|
|
Research and
development |
4,279 |
9,441 |
8,677 |
17,461 |
General and
administrative |
761 |
1,589 |
1,586 |
2,651 |
|
|
|
|
|
Total operating expenses |
5,040 |
11,030 |
10,263 |
20,112 |
|
|
|
|
|
Loss from operations |
(3,350) |
(9,792) |
(7,248) |
(17,386) |
Other income (expense) |
1 |
(126) |
(3) |
(125) |
|
|
|
|
|
Net loss and comprehensive loss |
(3,349) |
(9,918) |
(7,251) |
(17,511) |
Preferred stock deemed dividend |
-- |
-- |
-- |
(2,056) |
|
|
|
|
|
Net loss attributable to common
stockholders |
($3,349) |
($9,918) |
($7,251) |
($19,567) |
|
|
|
|
|
Net loss per common share, basic and
diluted |
($2.67) |
($0.98) |
($6.14) |
($3.27) |
|
|
|
|
|
Shares used to compute net loss per common
share, basic and diluted |
1,254 |
10,151 |
1,180 |
5,982 |
|
|
|
Consolidated Balance Sheet
Data |
(In thousands) |
|
December 31, |
June 30, |
|
2012 |
2013 |
|
|
|
Cash and cash equivalents |
$5,427 |
$91,146 |
Working capital |
71 |
83,422 |
Total assets |
6,903 |
92,596 |
Long-term debt |
-- |
4,824 |
Total liabilities |
7,070 |
13,476 |
Common stock and additional paid-in
capital |
7,606 |
144,220 |
Total stockholders' (deficit) equity |
(39,983) |
79,120 |
CONTACT: Media and Investor Contact:
Graham K. Cooper
Chief Financial Officer, Receptos
(858) 652-5708
gcooper@receptos.com
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