Receptos Reports First Quarter 2014 Financial Results
May 12 2014 - 8:00AM
- Top-line results of Phase 2 trial of
RPC1063 in relapsing multiple sclerosis expected in mid-2014
- - Phase 3 trial of RPC1063 in relapsing multiple
sclerosis enrolling patients globally - - Results
of Phase 2 trial of RPC1063 in ulcerative colitis expected in Q4
2014 - - Conference Call Today at 8:30
a.m. Eastern Time -
Receptos, Inc. (Nasdaq:RCPT) today provided development program
updates and announced financial results for the first quarter
ended March 31, 2014.
"We have successfully initiated the Phase 3 portion of the
RADIANCE trial of RPC1063 in relapsing multiple sclerosis, with
many of the Phase 2 clinical trial sites able to begin enrolling
Phase 3 patients," said Faheem Hasnain, Chief Executive Officer of
Receptos. "We look forward to near-term top-line results of
the Phase 2 portion of RADIANCE, as well as TOUCHSTONE, our Phase 2
study of RPC1063 in ulcerative colitis, and continued progress with
our pipeline programs."
Receptos is developing RPC1063, an orally administered
sphingosine 1-phosphate 1 (S1P1) receptor small molecule modulator
candidate, for immune indications including relapsing multiple
sclerosis (RMS) and ulcerative colitis (UC). The Company is
also developing RPC4046, an anti-interleukin-13 (IL-13) antibody
for an immune-mediated orphan disease, eosinophilic esophagitis
(EoE), and is in preclinical development of oral, small molecule,
positive allosteric modulators of the GLP‑1 receptor for the
treatment of Type 2 diabetes.
Development Program Updates
RPC1063 in Relapsing Multiple Sclerosis
- During the first quarter, Receptos sought Scientific Advice
from the European Medicines Agency (EMA) regarding the adequacy of
the planned Phase 3 clinical trials and the overall development
program in support of a future marketing authorization application
(MAA). The EMA raised no major objections regarding the design
of the Phase 3 clinical trials and indicated that with minor
adjustments, the proposed development program would be sufficient
to support an MAA in the European Union.
- Receptos has completed enrollment in the Phase 2 portion of
RADIANCE, its Phase 2/3 trial of RPC1063 in RMS. Top-line data
for this trial is expected in mid-2014. After completing a
pre-planned interim analysis of the Phase 2 portion of RADIANCE,
the Company initiated enrollment of the Phase 3 portion of the
trial. This is a randomized, double-blind, double-dummy study
designed to compare 0.5 mg and 1.0 mg of orally administered
RPC1063 against injected interferon beta-1a (Avonex®) in 1,200
patients with RMS. It is being conducted under a Special
Protocol Assessment (SPA) with the FDA.
RPC1063 in Ulcerative Colitis
- Receptos continues to enroll a randomized Phase 2 study
(TOUCHSTONE) for the treatment of UC, a serious
gastrointestinal disease. The primary objective of the trial 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 after eight weeks of treatment.
The trial is more than 80% enrolled, with top‑line results
anticipated in Q4 2014.
RPC4046 in Eosiniphilic Esophagitis
- Receptos is planning a randomized, placebo-controlled,
proof‑of‑concept Phase 2 study in patients with active
eosiniphilic esophagitis (EoE), an orphan, GI-related immunological
indication. In the first quarter, the Company filed an IND with the
Division of Gastroenterology of the FDA. Receptos plans to begin
enrollment of this trial in 2H 2014.
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 plans to conduct IND-enabling studies for
this program in 2014.
Key upcoming milestones
- Mid 2014: Top-line results of RADIANCE (Phase 2 portion of
trial of RPC1063 in RMS)
- 2H 2014: Initiation of Phase 2 trial of RPC4046 in EoE
- Q4 2014: Top-line results of TOUCHSTONE (Phase 2 trial of
RPC1063 in UC)
Financial highlights for the three months
ended March 31, 2014
- Net loss for the first quarter of 2014 was $21.5 million, or
$1.01 per share, compared to a net loss of $9.6 million, or $5.46
per share, for the first quarter of 2013.
- Total revenues for the first quarter of 2014 were $1.4 million,
compared to $1.5 million for the first quarter of
2013. Revenue during these periods consisted primarily of
amortization of upfront fees and milestone payments, which are
being recognized over the estimated period of performance, and
R&D funding received from our collaborative arrangements.
- Total operating expenses for the first quarter of 2014
were $22.8 million, compared to $9.1
million for the first quarter of 2013. Operating expenses for
the first quarter of 2014 include $1.8 million of stock
compensation expense, compared to $0.1 million of stock
compensation expense for the first quarter of 2013.
- Research and development ("R&D") expenses were $20.0
million for the first quarter of 2014, compared to $8.0 million for
the first quarter of 2013. 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 startup
costs for our Phase 2/3 trial of RPC1063 in RMS, and increased
activity related to the Phase 2 trial of RPC1063 in UC.
- General and administrative ("G&A") expenses were $2.8
million for the first quarter of 2014, compared to $1.1 million for
the first quarter of 2013. The increase in G&A expenses is
primarily related to the expansion of our operating activities and
costs associated with being a publicly-traded company. The overall
increase is comprised of an increase in personnel costs related to
additional headcount, additional stock-based compensation expense
of $0.8 million, and additional expenditures on outside services,
including consulting costs, legal and accounting fees and
insurance.
Other financial highlights
- Receptos had $158.6 million in cash and cash
equivalents as of March 31, 2014. Cash used in the Company's
operating activities totaled $20.5 million during the three months
ended March 31, 2014.
- As of March 31, 2014, the Company had term debt of $5.0 million
and approximately 22.2 million shares of common stock
outstanding.
Conference Call Today at 8:30 a.m. Eastern
Time (5:30 a.m. Pacific Time)
The Receptos management team will host a teleconference and
webcast to discuss the first quarter 2014 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), conference ID 32184280. 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 32184280.
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," "may," "intends," "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 safety, efficacy and projected development timeline
of drug candidates such as RPC1063 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 consistency of results from the interim
analysis discussed above and final trial results, the Company's
ability to adequately and timely recruit and enroll patients in its
clinical trials, as well as other 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 are described in detail in the
Company's SEC filings, including the Company's Annual
Report on Form 10-K. 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, eosiniphilic esophagitis
(EoE). Receptos has established expertise in high resolution
protein crystal structure determination, biology and drug discovery
for G-protein-coupled receptors (GPCRs).
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RECEPTOS, INC. |
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CONSOLIDATED FINANCIAL
RESULTS |
|
|
(In thousands, except per share amounts) |
|
|
|
|
|
Three months
ended March 31, |
|
2014 |
2013 |
|
|
|
Collaborative
revenue |
$1,350 |
$1,488 |
Operating expenses: |
|
|
Research and development |
20,007 |
8,020 |
General and administrative |
2,759 |
1,062 |
Total operating expenses |
22,766 |
9,082 |
|
|
|
Loss from
operations |
(21,416) |
(7,594) |
Interest income |
73 |
1 |
Interest expense |
(157) |
-- |
Net loss |
(21,500) |
(7,593) |
Preferred stock deemed dividend |
-- |
(2,056) |
Net loss attributable to common
stockholders |
($21,500) |
($9,649) |
|
|
|
Net loss per common share, basic and
diluted |
($1.01) |
($5.46) |
|
|
|
Shares used to compute net loss per common
share, basic and diluted |
21,195 |
1,767 |
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Note - The calculation of net
loss per common share for the three months ended March 31, 2013
excludes the impact of the conversion of all of the Company's
outstanding Series A and B convertible preferred stock into
9,644,000 shares of common stock in connection with our initial
public offering in May 2013. |
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RECEPTOS, INC. |
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CONSOLIDATED BALANCE SHEET
DATA |
|
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(IN THOUSANDS) |
|
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As of March 31, |
As of December
31, |
|
2014 |
2013 |
|
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Cash, cash equivalents and short-term
investments |
$158,571 |
$69,490 |
Working capital |
144,218 |
54,263 |
Total assets |
161,146 |
71,228 |
Term debt |
4,962 |
4,915 |
Total liabilities |
20,123 |
20,433 |
Common stock and additional paid-in
capital |
258,439 |
146,698 |
Total stockholders' equity |
141,023 |
50,795 |
CONTACT: Media and Investor Contact:
Graham K. Cooper
Chief Financial Officer, Receptos
(858) 652-5708
gcooper@receptos.com
Andrew McDonald
LifeSci Advisors, LLC
(646) 597-6987
andrew@lifesciadvisors.com
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