Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) Files An 8-K Results of Operations and Financial Condition
Item 2.02 Results of Operations and Financial Condition.
Commencing on January 8, 2017, we expect to disclose the
following information in discussions to be held in connection
with the Annual J.P. Morgan Healthcare Conference: As of December
31, 2016, Arena Pharmaceuticals, Inc. (the Company) had
approximately $90 million of cash and cash equivalents.See
additional information in the presentation furnished as an
Exhibit to Item 7.01.
Item 7.01 Regulation FD Disclosure.
Included as Exhibit 99.1 to this Form 8-K is a presentation
titled Corporate Presentation JP Morgan Healthcare Conference,
dated January 2017, which is incorporated herein by reference.We
intend to utilize this presentation in various meetings with
securities analysts, investors and others in connection with the
Annual J.P. Morgan Healthcare Conference, commencing on January
8, 2017.
The information contained in Exhibit 99.1 hereto is being
furnished and shall not be deemed filed for the purposes of
Section 18 of the Securities Exchange Act of 1934, as amended, is
not subject to the liabilities of that section and is not deemed
incorporated by reference in any filing under the Securities Act
of 1933, as amended, or the Securities Exchange Act of 1934, as
amended, except as shall be expressly set forth by specific
reference in such a filing.
Item 8.01 Other Events.
We are providing the following information to summarize and
update certain aspects of our publicly disclosed description of
our clinical programs.
Etrasimod
Etrasimod, an orally available modulator of the S1P receptor, is
our internally discovered investigational drug candidate intended
for the potential treatment of a number of autoimmune diseases.
S1P receptor modulators have been demonstrated to be involved in
several biological responses, including lymphocyte trafficking
from lymph nodes to the peripheral blood. By isolating
lymphocytes in lymph nodes, fewer immune cells are available in
the circulating blood to effect tissue damage. Drugs in this
class have been associated with certain side effects, including
cardiovascular effects, respiratory effects, infection, macular
edema and elevations in liver enzymes. We have optimized
etrasimod as a potent and selective small molecule S1P receptor
modulator that reduces the severity of disease in preclinical
autoimmune-disease models.
We are currently developing etrasimod for ulcerative colitis.In
July 2015, we initiated patient dosing in a 12-week, randomized,
double-blind and placebo-controlled Phase 2 clinical trial of
etrasimod for ulcerative colitis. We are working diligently to
obtain data from this trial by the end of 2017.To achieve our
goal of obtaining data from this trial by the end of 2017 and
lower costs, we are assessing potential changes to the trial
protocol that we believe would improve data readout and enhance
overall efficiency of the trial, while maintaining study conduct,
data integrity, patient safety and the overall study objectives.
In addition, to further enhance the overall profile of our
etrasimod program, we intend to explore development in additional
indications, including
Dermatological Extra-Intestinal Manifestations (EIM) in |
Pyoderma Gangrenosum (PG) |
Primary Biliary Cirrhosis (PBC) |
We are designing exploratory Phase II clinical trials for each of
these additional indications.We intend to initiate these Phase II
trials during 2017.
Ralinepag
Ralinepag, an oral, selective IP receptor agonist targeting the
prostacyclin pathway, is our internally discovered
investigational drug candidate intended for the treatment of
pulmonary arterial hypertension, or PAH. In September 2014,
ralinepag was granted orphan drug status for the treatment of PAH
by the FDA.
In January 2015, we initiated patient dosing in a 22-week,
randomized, double-blind and placebo-controlled Phase 2 clinical
trial of ralinepag. We completed enrollment in the trial in
December 2016 and expect to obtain data from this trial by the
end of the third quarter of 2017.
APD371
APD371, an orally available, peripherally restricted, highly
selective, full agonist of the cannabinoid-2 (CB2) receptor, is
an internally discovered investigational drug candidate we are
exploring for the treatment of pain.
In October 2015, we initiated a Phase 1 multiple-ascending dose
trial of APD371. In the first half of 2016, we completed this
trial with favorable results.In the first quarter of 2017, we
intend to commence a Phase 2 clinical trial of APD371 for pain
associated with Crohns disease and expect to obtain data from
this trial by the end of 2017.
Temanogrel
Temanogrel, an orally available inverse agonist of the serotonin
2A receptor, is an internally discovered investigational drug
candidate intended for the treatment of thrombotic diseases. We
believe temanogrel has the potential to inhibit
serotonin-mediated platelet aggregation and vasoconstriction. We
believe temanogrels dual mechanism may be therapeutically useful
for the treatment or prevention of thrombotic diseases.
We previously completed a Phase 1a clinical evaluation of
temanogrel, and provided Ildong Pharmaceuticals Co., Ltd., the
development and commercialization rights to temanogrel in South
Korea (while we retained all other rights worldwide). Ildong is
not currently advancing temanogrel in clinical trials for South
Korea. We are continuing to evaluate options for this program.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number |
Description |
99.1 |
Corporate Presentation JP Morgan Healthcare Conference |
Forward-Looking Statements
Statements in this report on Form 8-K that are not statements of
historical fact are forward-looking statements, which involve a
number of risks and uncertainties.Such forward-looking statements
include, without limitation, statements about the timing of
obtaining data from clinical trials, changes in clinical
protocol, and planned or intended clinical trials and
indications. Words such as believe, plan, expect, intend, will,
would, may, goal, potential and similar expressions are intended
to identify forward-looking statements, though not all
forward-looking statements necessarily contain these identifying
words. For such statements, we claim the protection of the
Private Securities Litigation Reform Act of 1995. Actual events
or results may differ materially from our expectations. Factors
that could cause actual results to differ materially from the
forward-looking statements include, but are not limited to, the
risk that we may not be able to recruit patients for certain
trials as anticipated, and the risk that we may not successfully
implement anticipated changes in clinical protocol, as well as
risks related to: research and development; regulatory approval;
commercialization; competition; intellectual property; and our
financial and other resources. Additional factors that could
cause actual results to differ materially from those stated or
implied by Arenas forward-looking statements are disclosed in our
filings with the Securities and Exchange Commission. These
forward-looking statements represent our judgment as of the time
of this report on Form 8-K. We disclaim any intent or obligation
to update these forward-looking statements, other than as may be
required under applicable law.
About Arena Pharmaceuticals, Inc. (NASDAQ:ARNA)
Arena Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing small molecule drugs that target G protein-coupled receptors (GPCRs). The Company’s drug, Lorcaserin, is approved for marketing in the United States and South Korea for the indication of weight management, and is being commercialized under the brand name, BELVIQ. The Company’s drug candidates in clinical development include APD334 for autoimmune diseases, ralinepag for vascular diseases and APD371 for pain. APD334 is an orally available modulator of the sphingosine 1-phosphate subtype 1 (S1P1) receptor intended for the treatment of multiple sclerosis, psoriasis, inflammatory bowel diseases and rheumatoid arthritis. The Company’s programs under collaboration include nelotanserin for dementia-associated psychosis, temanogrel for thrombotic diseases and an undisclosed orphan GPCR for central nervous system indication(s). Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) Recent Trading Information
Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) closed its last trading session 00.00 at 1.51 with 1,166,131 shares trading hands.