Spherix Reports Second Quarter 2009 Earnings
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BETHESDA, Md., Aug. 17 /PRNewswire-FirstCall/ -- Spherix Incorporated (Nasdaq:
SPEX), an innovator in biotechnology for diabetes therapy, and a provider of
technical and regulatory consulting services to food, supplement,
biotechnology and pharmaceutical companies, today reported results for the
second quarter ended June 30, 2009.
Recent and Upcoming Company Highlights
-- Biospherics Subsidiary
-- Clinical trials on Naturlose (D-tagatose) as a treatment for Type
2
diabetes:
-- Announced preliminary Phase 2 clinical trial data
demonstrating
reduction of HbA1c levels with doses of Naturlose an order of
magnitude lower than the dose used in the current Phase 3
trial
-- Spherix anticipates having Phase 3 interim data results in
third
quarter of 2009
-- Completion of the Phase 2 Dose Range clinical trial expected
in
mid-2010
-- Completion of the Phase 3 clinical trial expected in mid- to
late-2010
-- Received first production batch of cGMP (FDA Current Good
Manufacturing Practice) D-tagatose, USP (U.S. Pharmacopeia) grade
from Inalco S.p.A., of Italy
-- Upcoming trade shows/investor conferences:
-- Rodman & Renshaw 11(th) Annual Health Conference, New York,
NY, Sept. 9-11
-- American Academy of Family Practice, Boston, MA, Oct. 14-17
-- BIO Investor Forum, San Francisco, CA, Oct. 28-30
-- Spherix Consulting Subsidiary
-- Upcoming professional and trade shows:
-- American College of Toxicology, 30(th) Annual Meeting, Palm
Springs, CA, Nov. 1-4
-- Calorie Control Council, Ponte Vedra Beach, FL
-- Supply Side West, Las Vegas, NV, Nov. 11-13
"As announced on June 24, 2009, preliminary data from our Phase 2 dosing trial
demonstrated statistically significant reductions in HbA1c levels at doses of
Naturlose that are well below those being evaluated in the current Phase 3
trial," said Claire L. Kruger, CEO of Spherix. "We are excited by what these
data suggest and the Company is pursuing steps to aggressively escalate our
pharmaceutical marketing and commercialization plans for Naturlose. These
plans include the formation of up to three regional Medical Advisory Boards,
possibly as early as September 2009."
"Also in June, the Company received its first production batch of D-tagatose
from Inalco S.p.A., a truly significant milestone on a number of levels.
First, it shines a light on the full-scale cGMP process that will be used to
produce Naturlose for use by patients in our Phase 3 clinical trial as well as
for the anticipated commercialization of the drug. Second, as part of the Food
and Drug Administration (FDA) approval process, a Drug Master File (DMF) has
been submitted to the FDA and Spherix has a Letter of Authorization to refer
to the DMF when it ultimately files its New Drug Application for Naturlose.
Finally, receipt of this batch demonstrates Spherix's ability to use multiple
sources to deliver the high volume of doses of Naturlose that would be needed
to meet patient demands should we receive FDA approval."
"On a corporate level, I am happy to welcome Thomas B. Peter to the Company's
Board. Mr. Peter's experience with GlaxoSmithKline and the commercialization
of that company's Type 2 diabetes drug, Avandia, will be an invaluable
addition to the vast expertise of the Company's Board members and officers."
Financial Results for the Quarter Ended June 30, 2009
Revenue was $332,000 for the quarter ended June 30, 2009, up from $263,000 in
2008 for the same period. Direct costs saw a corresponding increase to
$109,000 from $99,000 between the same periods. The Company's revenue
improvement reflects the growth of its health sciences consulting services
("Spherix Consulting").
Research and development expenses were $1.1 million in the quarter, up from
$710,000 of the previous year. The increase in R&D expenses is related to
the expansion of the Phase 3 trial to India. The Company's R&D expenses for
both years consisted of costs for both the Phase 3 and Phase 2 clinical
trials.
Selling, general and administrative expenses for the quarter were $649,000,
down from $741,000 in the second quarter of 2008.
The net loss for the quarter ended June 30, 2009 was $1.6 million or $0.11 per
share, compared with a net loss of $1.2 million or $0.08 per share for the
same period in 2008.
Second-Quarter Conference Call
The Company will host a conference call tomorrow to discuss the results and
business expectations. See instructions below to participate on the call.
Earnings Call: August 18, 2009 10:00 AM (Eastern Daylight Time)
Webcast Link:
http://investor.shareholder.com/media/eventdetail.cfm?mediaid=38377&c=SPEX&mediakey=47428C023E5416121767808CC1AE28D3&e=0
Dial-in Information
Conference telephone number: 888-359-3610
Confirmation Code: 4748859
About Spherix
Spherix Incorporated was launched in 1967 as a scientific research company,
under the name Biospherics Research. The company now leverages its scientific
and technical expertise and experience through its two subsidiaries --
Biospherics Incorporated and Spherix Consulting, Inc. Biospherics is
currently running a Phase 3 clinical trial to study the use of Naturlose as a
treatment for Type 2 diabetes. Its Spherix Consulting subsidiary provides
scientific and strategic support for suppliers, manufacturers, distributors
and retailers of conventional foods, biotechnology-derived foods, medical
foods, infant formulas, food ingredients, dietary supplements, food contact
substances, pharmaceuticals, medical devices, consumer products, and
industrial chemicals and pesticides. For more information, please visit
www.spherix.com.
Forward-Looking Statements
This release contains forward-looking statements which are made pursuant to
provisions of Section 21E of the Securities Exchange Act of 1934. Investors
are cautioned that such statements in this release, including statements
relating to planned clinical study design, regulatory and business strategies,
plans and objectives of management and growth opportunities for existing or
proposed products, constitute forward-looking statements which involve risks
and uncertainties that could cause actual results to differ materially from
those anticipated by the forward-looking statements. The risks and
uncertainties include, without limitation, risks that product candidates may
fail in the clinic or may not be successfully marketed or manufactured, we may
lack financial resources to complete development of Naturlose, the FDA may
interpret the results of studies differently than us, competing products may
be more successful, demand for new pharmaceutical products may decrease, the
biopharmaceutical industry may experience negative market trends, our
continuing efforts to develop Naturlose may be unsuccessful, our common stock
could be delisted from the Nasdaq Capital Market, and other risks and
challenges detailed in our filings with the U.S. Securities and Exchange
Commission, including our current report on Form 8-K filed on October 10,
2007. Readers are cautioned not to place undue reliance on any
forward-looking statements which speak only as of the date of this release.
We undertake no obligation to publicly release the results of any revisions to
these forward-looking statements that may be made to reflect events or
circumstances that occur after the date of this release or to reflect the
occurrence of unanticipated events.
- Tables Follow -
Spherix Incorporated
Consolidated Statements of Operations
For the Three and Six Months Ended June 30, 2009 and 2008
(Unaudited)
Three Months Ended June 30, Six Months Ended June 30,
--------------------------- -------------------------
2009 2008 2009 2008
---- ---- ---- ----
Revenue $332,241 $263,151 $692,911 $406,059
----------- ----------- ----------- -----------
Operating expense
Direct costs 109,123 98,825 239,665 160,419
Research and
Development expense 1,133,962 709,941 2,695,351 1,741,149
Selling, general and
Administrative
Expense 649,096 741,295 1,408,366 1,842,210
----------- ----------- ----------- -----------
Total operating
Expense 1,892,181 1,550,061 4,343,382 3,743,778
----------- ----------- ----------- -----------
Loss from operations (1,559,940) (1,286,910) (3,650,471) (3,337,719)
Interest income 5,400 88,637 29,847 225,212
----------- ----------- ----------- -----------
Loss before taxes (1,554,540) (1,198,273) (3,620,624) (3,112,507)
Income tax expense - - - -
----------- ----------- ----------- -----------
Net loss $(1,554,540) $(1,198,273) $(3,620,624) $(3,112,507)
=========== =========== =========== ===========
Net loss per share,
basic $(0.11) $(0.08) $(0.25) $(0.22)
Net loss per share,
diluted $(0.11) $(0.08) $(0.25) $(0.22)
Weighted average
shares outstanding,
basic 14,357,162 14,318,702 14,357,162 14,318,702
=========== =========== =========== ===========
Weighted average
shares outstanding,
diluted 14,357,162 14,318,702 14,357,162 14,318,702
----------- ----------- ----------- -----------
Spherix Incorporated
Consolidated Balance Sheets
As of June 30, 2009 (unaudited) and December 31, 2008
ASSETS June 30, 2009 December 31,
(Unaudited) 2008
----------- ----
Current assets
Cash and cash equivalents $6,392,955 $9,404,843
Short-term investments 1,599,346 1,894,434
Trade accounts receivable 339,356 281,342
Other receivables 6,142 37,223
Prepaid expenses and other assets 174,979 282,971
----------- -----------
Total current assets 8,512,778 11,900,813
Property and equipment, net 261,952 310,365
Patents, net of accumulated
amortization of $41,622 and $38,588 11,398 14,433
Deposit 35,625 35,625
----------- -----------
Total assets $8,821,753 $12,261,236
=========== ===========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable and accrued expenses $982,697 $710,881
Accrued salaries and benefits 230,524 304,756
Deferred revenue 96,316 39,347
----------- -----------
Total current liabilities 1,309,537 1,054,984
Deferred compensation 585,000 660,000
Deferred rent 122,444 136,736
----------- -----------
Total liabilities 2,016,981 1,851,720
----------- -----------
Commitments and contingencies - -
Stockholders' equity
Preferred stock, $0.01 par
value, 2,000,000 shares authorized;
none issued and outstanding - -
Common stock, $0.005 par value,
50,000,000 shares authorized;
14,437,600 issued, and 14,357,162
shares outstanding at June 30, 2009
and December 31, 2008 72,188 72,188
Paid-in capital in excess of
par value 27,618,366 27,602,486
Treasury stock, 80,438 shares, at
cost at June 30, 2009 and
December 31, 2008 (464,786) (464,786)
Accumulated deficit (20,420,996) (16,800,372)
----------- -----------
Total stockholders' equity 6,804,772 10,409,516
----------- -----------
Total liabilities and
stockholders' equity $8,821,753 $12,261,236
----------- -----------
SOURCE Spherix Incorporated
Investor Relations of Spherix Incorporated, +1-301-897-2564, info@spherix.com
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