Receptos Reports Third Quarter 2013 Financial Results
October 30 2013 - 4:22PM
- Phase 2 trial of RPC1063 in relapsing
multiple sclerosis has completed enrollment; interim results to be
reviewed in Q4 2013 -
- Phase 2 trial of RPC1063 in ulcerative
colitis continues to enroll patients globally -
- Results of thorough QT Study recently
presented at ECTRIMS -
- Conference Call Today at 5 p.m. Eastern
Time -
Receptos, Inc. (Nasdaq:RCPT) today provided development program
updates and announced financial results for the third quarter ended
September 30, 2013.
"We continue to execute on our Phase 2 trials of RPC1063 in
relapsing multiple sclerosis (RMS) and ulcerative colitis (UC),"
said Faheem Hasnain, Chief Executive Officer of Receptos. "Having
now completed enrollment in the RMS trial, our timeline for
reporting top-line data in mid-2014 is maintained. In addition, we
look forward to the interim review of the RMS trial later this
quarter, which will gate our decision to initiate Phase 3 in the
coming weeks."
Receptos is developing RPC1063, a sphingosine 1-phosphate 1
(S1P1) receptor small molecule modulator candidate, for immune
indications. The Company is currently conducting separate Phase 2
trials in RMS and UC, with top-line data expected for both trials
in mid-2014. 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
- Receptos has completed enrollment in the Phase 2 portion
of an accelerated, randomized Phase 2/3 study (RADIANCE) for
the treatment of RMS.
- The Company anticipates 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 continue to be
expected in mid-2014. The primary objective of the Phase 2
portion of the study 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 recently reviewed 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). The study ruled out a QTc effect
for RPC1063 at both the therapeutic and the supra-therapeutic
doses. The study also confirmed a modest heart rate effect,
which was attenuated by the dose titration regimen that was
utilized.
RPC1063 in Ulcerative Colitis
- Receptos continues to enroll a randomized Phase 2 study
(TOUCHSTONE) for the treatment of 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 after eight weeks of
treatment.
RPC4046 in Eosinophilic Esophagitis
- Receptos is in the planning stages of a Phase 2
proof‑of‑concept study in patients with active eosinophilic
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 transfer the previous
IND to the Division of Gastroenterology of the FDA, and has
scheduled a pre-IND meeting in the fourth quarter of
2013. Submission of an IND in the first half of 2014 would
facilitate the initiation of a Phase 2 trial, as a Phase 1
study has previously been completed in another indication.
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.
Financial highlights for the three and nine months
ended September 30, 2013
Third quarter 2013 financial results (three months ended
September 30, 2013)
- Net loss for the third quarter of 2013 was $15.6 million, or
$0.88 per share, compared to a net loss of $6.0 million, or $4.44
per share, for the third quarter of 2012.
- Total revenues for the third quarter of 2013 were $1.1 million,
compared to $1.8 million for the third 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 third quarter of 2013
were $16.6 million, compared to $7.8
million for the third quarter of 2012. Operating expenses for
the third quarter of 2013 include $1.1 million of stock
compensation expense, compared to $50,000 of stock compensation
expense for the third quarter of 2012.
- Research and development ("R&D") expenses were $13.5
million for the third quarter of 2013 compared to $6.8 million for
the third 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 $3.1
million for the third quarter of 2013 compared to $1.0 million for
the third quarter of 2012. The increase in G&A costs is
primarily related to increased personnel costs, additional stock
compensation and additional expenditures on outside services,
including consulting costs, legal fees and insurance.
Year to date 2013 financial results (nine months
ended September 30, 2013)
- Net loss attributable to common shareholders for 2013 was $35.1
million, or $3.54 per share, compared to a net loss of $13.3
million, or $10.71 per share, for 2012.
- Total revenues for the first nine months of 2013 were $3.9
million compared to $4.8 million for the comparable period 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 first nine months of 2013
were $36.7 million compared to $18.1
million for the comparable period of 2012. Operating
expenses for the first nine months of 2013 include $1.7 million of
stock compensation expense, compared to $0.1 million of stock
compensation expense for the comparable period of 2012.
- R&D expenses were $31.0 million for the first nine months
of 2013 compared to $15.4 million for the comparable period of
2012. 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.
- G&A expenses were $5.7 million for the first nine months of
2013 compared to $2.6 million for the comparable period of 2012.
The increase in G&A costs is primarily related to increased
personnel costs, additional stock compensation and additional
expenditures on outside services, including consulting costs, legal
fees and insurance.
Other financial highlights
- Receptos had $80.8 million in cash and cash
equivalents as of September 30, 2013. Cash used in the
Company's operating activities totaled $10.3 million and $25.6
million during the three and nine months ended September 30,
2013.
- As of September 30, 2013, the Company had term debt of $4.9
million and approximately 18.3 million shares of common stock
outstanding.
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 third 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), conference ID 91681088. 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 91681088.
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 September 30, |
Nine months ended
September 30, |
|
2012 |
2013 |
2012 |
2013 |
|
|
|
|
|
Collaborative revenue |
$1,794 |
$1,142 |
$4,809 |
$3,868 |
Operating expenses: |
|
|
|
|
Research and development |
6,757 |
13,500 |
15,434 |
30,961 |
General and administrative |
1,041 |
3,050 |
2,627 |
5,701 |
|
|
|
|
|
Total operating expenses |
7,798 |
16,550 |
18,061 |
36,662 |
|
|
|
|
|
Loss from operations |
(6,004) |
(15,408) |
(13,252) |
(32,794) |
Other income (expense) |
1 |
(157) |
(2) |
(282) |
|
|
|
|
|
Net loss and comprehensive
loss |
(6,003) |
(15,565) |
(13,254) |
(33,076) |
Preferred stock deemed dividend |
-- |
-- |
-- |
(2,056) |
|
|
|
|
|
Net loss attributable to common
stockholders |
($6,003) |
($15,565) |
($13,254) |
($35,132) |
|
|
|
|
|
Net loss per common share, basic and
diluted |
($4.44) |
($0.88) |
($10.71) |
($3.54) |
|
|
|
|
|
Shares used to compute net loss per common
share, basic and diluted |
1,351 |
17,715 |
1,237 |
9,928 |
|
RECEPTOS,
INC. |
CONSOLIDATED BALANCE
SHEET DATA |
(IN THOUSANDS) |
|
December 31, |
September 30, |
|
2012 |
2013 |
|
|
|
Cash and cash equivalents |
$5,427 |
$80,781 |
Working capital |
71 |
68,618 |
Total assets |
6,903 |
82,101 |
Long-term debt |
-- |
4,428 |
Total liabilities |
7,070 |
17,397 |
Common stock and additional paid-in
capital |
7,606 |
145,369 |
Total stockholders' (deficit) equity |
(39,983) |
64,704 |
CONTACT: Media and Investor Contact:
Graham K. Cooper
Chief Financial Officer, Receptos
(858) 652-5708
gcooper@receptos.com
Michael Rice
LifeSci Advisors, LLC
(646) 597-6979
mrice@lifesciadvisors.com
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