DARA BioSciences Announces First Quarter 2014 Results
Company Implemented New Nationwide Sales Force in January;
Complemented Oncology Supportive Care Product Portfolio
RALEIGH, NC--(Marketwired -
May 12, 2014) - DARA BioSciences, Inc. (NASDAQ: DARA), an oncology supportive care
pharmaceutical company dedicated to providing health care
professionals a synergistic portfolio of medicines to help cancer
patients adhere to their therapy and manage side effects arising
from their cancer treatment, today announced its first quarter 2014
results.
First Quarter 2014
Financial Snapshot For the first quarter ended March 31,
2014, DARA reported a net loss attributable to controlling interest
of ($2,658,081), or ($0.37) per share as compared to a net loss
attributable to controlling interest of ($2,522,588), or ($0.55)
per share for the first quarter ended March 31, 2013. As of March
31, 2014, cash and cash equivalents totaled $6,828,100.
"We are excited by the progress we have made in the first
quarter as we had several events transpire that we believe are
integral to the success of the DARA strategy going forward," stated
Dr. David J. Drutz, Chief Executive Officer and Chief Medical
Officer of DARA BioSciences. "We completed the training and
implementation of our expanded sales force that is driving demand
for our commercial product portfolio, received Orphan Drug
Designation for our key development asset, KRN5500, and raised
additional capital to continue funding our business operations
going forward."
Dr. Drutz continued, "We remain committed to raising the
necessary capital to effectively operate and continue to drive the
positive momentum of our corporate growth strategy. During the
first quarter, we successfully raised gross proceeds of $6 million
through a registered direct offering of shares and concurrent
private placement of warrants designed to fund our ongoing business
operations. Consistent with our recently amended S-1 filing, any
additional funding this year will be primarily focused on our
ongoing business operations, continuing to drive our commercial
sales efforts, and providing flexibility as we evaluate new product
opportunities in supportive care as well as pursue partnership
opportunities around KRN5500."
First Quarter 2014
Operational Highlights And Recent Key Events The Company
made significant progress during the first quarter of 2014 in
executing its strategy as well as expanding the commercial
opportunity for its flagship oncology and oncology supportive care
products.
- The FDA granted Orphan Drug Designation to KRN5500 on February
24, 2014 for the parenteral treatment of painful, chronic,
chemotherapy-induced peripheral neuropathy that is refractory to
conventional analgesics. Orphan drug designation provides
extended market exclusivity, tax benefits, and the waiver of
certain fees associated with the FDA approval process. The
company's primary efforts relative to KRN5500 are centered around
finding a long-term development partner for the drug.
- DARA successfully completed a one-for-five reverse split of our
outstanding common stock during the quarter.
- The Company conducted a registered direct offering
of 2,166,501 shares of the Company's common stock at an
offering price of $2.765 per share (the "February 2014 Share
Offering"). In a concurrent private placement, the Company
issued to each participating investor a warrant to purchase
one share of the Company's common stock for each share purchased in
the February 2014 Share Offering.
- DARA signed a pharmacy supply agreement with RainTree Oncology
Services, the nation's leading community oncology alliance, for
both Gelclair and Soltamox to be accessible to RainTree's
Nationwide Oncology Membership.
- The Company implemented a nationwide sales force of 20
representatives in January through a strategic partnership with
Alamo Pharma Services.
- Through arrangements with Mission Pharmacal, DARA complemented
its Oncology Supportive Care portfolio to feature 6 products,
enhancing what the Company believes is a comprehensive offering in
this speacialty focus in the industry.
- The Company signed a Medicare Part D Prescription Drug
Agreement with The WellCare Group, providing approved formulary
status for Soltamox.
- The Company presented a poster of its CAPTURE registry at the
National Comprehensive Cancer Network (NCCN) meeting in March with
data indicating that 13% of patients would prefer an oral liquid
version of tamoxifen.
Dr. Drutz concluded, "As we move further into 2014, we will
continue to focus on driving long-term growth and maintaining the
momentum gained in recent quarters. We believe our efforts to
enhance the effectiveness of our commercial sales strategy will
continue to support opportunities for revenue generation while we
actively pursue partnerships and evaluate options to maximize the
value of KRN5500. We believe this pragmatic and value-added
approach will help us find continued success, leaving us well
positioned to execute our long-term strategy to achieve sustainable
growth and profitability for our shareholders."
DARA believes that its currently available funds, together with
projected sales of current products provides for sufficient
resources to fund its currently planned operations through the
third quarter of 2014. Current products include:
- Soltamox®, (tamoxifen citrate) oral liquid solution;
- Gelclair®, a bioadherent oral rinse gel for treating the
painful symptoms of oral mucositis (OM);
- Bionect®, (hyaluronic acid sodium salt, 0.2%) a topical
treatment for skin irritation and burns associated with radiation
therapy;
- Ferralet® 90 (for anemia)*;
- BINOSTO® (alendronate sodium effervescent tablet indicated for
the treatment of osteoporosis)*, and;
- Aquoral® (for cancer-related dry mouth)*
*By arrangement with Mission Pharmacal.
Financial
Highlights A summary of key financial highlights for the
three ended March 31, 2014 and 2013 is as follows ($ in
thousands):
|
|
|
|
|
|
|
For the three months ended March 31, 2014 |
|
For the three months ended March 31, 2013 |
Net revenues |
|
$ |
161.5 |
|
$ |
21.2 |
Gross margin |
|
|
108.3 |
|
|
3.7 |
Operating expenses |
|
|
3,018.6 |
|
|
2,731.1 |
|
|
|
|
|
|
|
Net loss attributable to controlling interest |
|
|
(2,658.1) |
|
|
(2,522.6) |
|
|
|
As of
March 31, 2014 |
|
|
As of
December 31, 2013 |
Cash and cash equivalents |
|
|
6,828.1 |
|
|
3,425.5 |
Current assets |
|
|
7,502.0 |
|
|
3,888.6 |
Current liabilities |
|
|
2,019.2 |
|
|
1,675.1 |
Working capital |
|
|
5,482.8 |
|
|
2,213.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONFERENCE CALL WEBCAST As previously announced, the
Company's management team will host a conference call and live
audio webcast to provide a corporate business update and review
first quarter 2014 financial results on Tuesday, May 13, 2014,
at 09:00 a.m. Eastern Time. To listen to the live call, individuals
can access the webcast at the investor relations portion of the
Company's website at http://ir.darabio.com/overview. Please
log on to the website at least 15 minutes early to register,
download and install any necessary audio software. For those
who cannot listen to the live broadcast, replays will be available
shortly after the call on the Dara BioSciences website at
http://www.darabio.com and will be archived for 30 days.
About DARA BioSciences,
Inc. DARA BioSciences Inc. of Raleigh, North Carolina, is an
oncology supportive care pharmaceutical company dedicated to
providing healthcare professionals a synergistic portfolio of
medicines to help cancer patients adhere to their therapy and
manage side effects arising from their cancer treatments.
DARA holds exclusive U.S. marketing rights to Soltamox
(tamoxifen citrate) oral solution, the only liquid form of
tamoxifen, used for the treatment and prevention of breast cancer.
Soltamox offers a choice to patients who prefer or need a liquid
form of tamoxifen. Tamoxifen is indicated for the treatment of
ductal carcinoma in situ (DCIS); as adjuvant treatment of
node-positive breast cancer; in the treatment of metastatic breast
cancer; and for breast cancer risk reduction in high risk women.
Currently, there are more than 1.8 million prescriptions of
tamoxifen written on an annual basis in the United States. Between
30 and 70 percent of patients fail to complete their prescribed
course of treatment, thereby diminishing its benefits in reducing
the risk of breast cancer recurrence.
Tamoxifen Important
Safety Information Tamoxifen citrate is contraindicated in
women who require concomitant coumarin-type anticoagulant therapy,
in women with a history of deep vein thrombosis or pulmonary
embolus, and in women with known hypersensitivity to the drug or
any of its ingredients.
Serious and life-threatening events associated with tamoxifen in
the risk reduction setting (women at high risk for cancer and women
with DCIS) include uterine malignancies, stroke and pulmonary
embolism.
The most common adverse reactions to tamoxifen treatment are
(incidence > 20%) hot flashes, fluid retention, vaginal
discharge, vaginal bleeding, vasodilatation, nausea, irregular
menses, weight loss, and musculoskeletal events.
Tamoxifen carries the following Black Box Warning:
WARNING - For Women with Ductal Carcinoma in Situ (DCIS) and
Women at High Risk for Breast Cancer: Serious and life-threatening
events associated with tamoxifen in the risk reduction setting
(women at high risk for cancer and women with DCIS) include uterine
malignancies, stroke and pulmonary embolism. Incidence rates for
these events were estimated from the NSABP P-1 trial (see CLINICAL
PHARMACOLOGY, Clinical Studies, Reduction in Breast Cancer
Incidence In High Risk Women). Uterine malignancies consist of both
endometrial adenocarcinoma (incidence rate per 1,000 women-years of
2.20 for tamoxifen vs. 0.71 for placebo) and uterine sarcoma
(incidence rate per 1,000 women-years of 0.17 for tamoxifen vs. 0.0
for placebo)*. For stroke, the incidence rate per 1,000 women-years
was 1.43 for tamoxifen vs. 1.00 for placebo**. For pulmonary
embolism, the incidence rate per 1,000 women-years was 0.75 for
tamoxifen versus 0.25 for placebo**. Some of the strokes, pulmonary
emboli, and uterine malignancies were fatal. Health care providers
should discuss the potential benefits versus the potential risks of
these serious events with women at high risk of breast cancer and
women with DCIS considering tamoxifen to reduce their risk of
developing breast cancer. The benefits of tamoxifen outweigh its
risks in women already diagnosed with breast cancer.
*Updated long-term follow-up data (median length of follow-up is
6.9 years) from NSABP P-1 study. See WARNINGS, Effects on the
Uterus-Endometrial Cancer and Uterine Sarcoma in Prescribing
Information. **See Table 3 under CLINICAL PHARMACOLOGY, Clinical
Studies in Prescribing Information.
The full Prescribing Information for Soltamox is available at
www.soltamox.com/prescribing-information.
Gelclair is an alcohol-free bioadherent oral rinse gel for rapid
and effective relief of pain associated with oral mucositis caused
by chemotherapy and radiation treatment. Gelclair should not be
used by patients with a known or suspected hypersensitivity to the
product or any of its ingredients. DARA licensed the U.S. rights to
Soltamox from UK-based Rosemont Pharmaceuticals, Ltd., and Gelclair
from the Helsinn Group in Switzerland. Under an agreement with
Innocutis, DARA also markets Bionect (hyaluronic acid sodium salt,
0.2%) a topical treatment for skin irritation and burns associated
with radiation therapy, in U.S. oncology/radiology markets. Bionect
should not be used by patients with known hypersensitivity to any
of its ingredients. For further information on Gelclair and Bionect
and the Full Prescribing Information please visit www.Gelclair.com
and www.Bionect.com.
DARA is focused on expanding its portfolio of oncology
supportive care products in the United States, via in-licensing
and/or partnering of complementary late-stage and approved
products. In addition, the company wishes to identify a strategic
partner for the clinical development of KRN5500, currently in Phase
2 for the treatment of chronic, treatment refractory,
chemotherapy-induced peripheral neuropathy (CCIPN). The FDA has
designated KRN5500 as a Fast Track Drug and has granted Orphan Drug
Designation to KRN5500 for the parenteral treatment of CCIPN.
In early 2014, DARA kicked off its new partnership with Alamo
Pharma Services, a subsidiary of Mission Pharmacal, in deploying a
dedicated 20-person national sales team in the U.S. oncology
market. In addition to promoting DARA's products Soltamox
(tamoxifen citrate), Gelclair and Bionect, this specialized
oncology supportive care sales team also provides clinicians with
access to three Mission Pharmacal products: Ferralet 90 (for
anemia), BINOSTO (alendronate sodium effervescent tablet indicated
for the treatment of osteoporosis), and Aquoral (for
chemotherapy/radiation therapy-induced dry mouth).
Important Safety Information and full Prescribing Information
for Mission Pharmacal's products may be found at: www.Ferralet.com,
www.Binosto.com, and www.Aquoral.com.
For more information please visit our web site at
www.darabio.com.
Safe Harbor Statement
All statements in this news release that are not historical are
forward-looking statements within the meaning of the Securities
Exchange Act of 1934, as amended, and are subject to risks and
uncertainties. These statements are based on the current
expectations, estimates, forecasts and projections regarding
management's beliefs and assumptions. In some cases, you can
identify forward looking statements by terminology such as "may,"
"will," "should," "hope," "expects," "intends," "plans,"
"anticipates," "contemplates," "believes," "estimates," "predicts,"
"projects," "potential," "continue," and other similar terminology
or the negatives of those terms. Such forward-looking statements
are subject to factors that could cause actual results to differ
materially for DARA from those projected. Important factors that
could cause actual results to differ materially from the
expectations described in these forward-looking statements are set
forth under the caption "Risk Factors" in DARA's most recent Annual
Report on Form 10-K, filed with the SEC on February 4, 2014, and
DARA's other filings with the SEC from time to time. Those factors
include risks and uncertainties relating to DARA's ability to
timely commercialize and generate revenues or profits from
Soltamox, Gelclair, Bionect or other products given that DARA only
recently hired its initial sales force and DARA's lack of history
as a revenue-generating company, DARA's ability to achieve the
desired results from the agreements with Mission and Alamo, FDA and
other regulatory risks relating to DARA's ability to market
Soltamox, Gelclair, Bionect or other products in the United States
or elsewhere, DARA's ability to in-license and/or partner products,
DARA's current cash position and its need to raise additional
capital in order to be able to continue to fund its operations,
DARA's ability to raise sufficient capital and on favorable terms
and the stockholder dilution that may result therefrom, the current
regulatory environment in which DARA sells its products, the market
acceptance of those products, dependence on partners, successful
performance under collaborative and other commercial agreements,
competition, the strength of DARA's intellectual property and the
intellectual property of others, the potential delisting of DARA's
common stock from the NASDAQ Capital Market, and other risk factors
identified in the documents DARA has filed, or will file, with the
Securities and Exchange Commission ("SEC"). Copies of DARA's
filings with the SEC may be obtained from the SEC Internet site at
http://www.sec.gov. DARA expressly disclaims any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in DARA's expectations with regard thereto or any change in events,
conditions, or circumstances on which any such statements are
based. DARA BioSciences and the DARA logo are trademarks of DARA
BioSciences, Inc.
CONTACT Jim Polson FTI Consulting 312-553-6730
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