Navigation Links
Ardea Biosciences, Inc. Reports Third Quarter 2007 Operating and Financial Results
Date:11/14/2007

Recent Accomplishments Include: - Successful completion of Phase 1 studies of novel HIV NNRTI, RDEA806

- Presentation of Phase 1 data on RDEA806 at key infectious disease

conference - Clearance granted by FDA to commence Phase 1 clinical trials in advanced

cancer patients with lead MEK inhibitor, RDEA119 - Presentation of RDEA119 preclinical data at key oncology conference

CARLSBAD, Calif., Nov. 14 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. ("Ardea" or the "Company") (Nasdaq: RDEA), a company focused on the discovery and development of small-molecule therapeutics for the treatment of viral diseases, cancer and inflammatory diseases, today reported financial and operating results for the three months and nine months ended September 30, 2007.

Ardea reported a loss applicable to common stockholders of $7.4 million ($0.72 per basic and diluted share) on revenues of $1.1 million for the third quarter of 2007, compared to a profit of $116,000 ($0.01 per share) for the third quarter of 2006. For the nine months ended September 30, 2007, the Company lost $16.2 million ($1.67 per basic and diluted share) on revenues of $2.8 million, compared to a loss of $131,000 ($0.01 per share) for the corresponding nine-month period in 2006. During 2006, the Company had no revenue. The results for the quarter and nine months ended September 30, 2007 include respective non-cash charges of $421,000 ($0.04 per share) and $784,000 ($0.08 per share) for stock compensation expense. The difference between 2007 and 2006 results reflects Ardea's re-start and rebuilding of operations.

"This past quarter proved to be highly productive," said Barry D. Quart, President and CEO. "We made significant progress in advancing our business and in the development of our pipeline, achieving several important milestones." These include:

-- Completion of Phase 1 single-ascending-dose, multiple-ascending-dose,

food-effect, and drug-interaction clinical studies of RDEA806, our lead

non-nucleoside reverse transcriptase inhibitor (NNRTI) for HIV, in

August of 2007;

-- Presentation of four posters describing the favorable results of

preclinical and Phase 1 clinical trials with RDEA806 during the 47th

Annual Interscience Conference on Antimicrobial Agents and Chemotherapy

(ICAAC);

-- Completion, submission and FDA approval of our investigational new drug

application (IND) for our lead mitogen-activated ERK kinase (MEK)

inhibitor, RDEA119, allowing us to proceed to Phase 1 clinical trials

in advanced cancer patients; and

-- Presentation of RDEA119 preclinical data, showing favorable properties,

including oral dosing, excellent selectivity and low central nervous

system (CNS) penetration, at the American Association of Cancer

Research (AACR), National Cancer Institute (NCI) and European

Organization for Research and Treatment of Cancer (EORTC) International

Conference on Molecular Targets and Cancer Therapeutics.

"We are well positioned for continued progress and success with our development programs in viral diseases, cancer and inflammatory diseases and are working to achieve several milestones in the next few months," added Dr. Quart. These include:

-- Initiation of a Phase 2a proof-of-concept trial with our lead NNRTI,

RDEA806;

-- Assessing a next-generation NNRTI from our follow-on program in a

first-in-human micro-dosing study;

-- Initiation of a Phase 1 advanced cancer clinical study of our lead MEK

inhibitor, RDEA119;

-- Initiation of a program to evaluate RDEA119 in inflammatory diseases;

and

-- Assessing a next-generation MEK inhibitor from our follow-on program in

a first-in-human micro-dosing study.

On September 30, 2007, Ardea had a total of $35.6 million in cash, cash equivalents and short-term investments. Based on current projections, the Company expects cash, cash equivalents, and short-term investments on December 31, 2007 to be approximately $28 million. The Company expects its current cash resources to fund operations through 2008. These projections exclude the potential impact of any future business development or financing activity.

Approximately 11.8 million common equivalent shares were issued and outstanding on September 30, 2007, including 1.6 million common shares underlying outstanding convertible preferred stock.

About Ardea Biosciences, Inc.

Ardea Biosciences is focused on the discovery and development of small-molecule therapeutics for the treatment of viral diseases, cancer and inflammatory diseases. The Company plans to initiate clinical studies on four compounds this year. These include RDEA806, the Company's lead non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV, which recently completed Phase 1 clinical trials, RDEA119, a mitogen-activated ERK kinase (MEK) inhibitor for the treatment of cancer and inflammatory diseases, which has been cleared by the FDA to enter Phase 1 clinical trials, and a follow-on NNRTI and a follow-on MEK inhibitor, both of which are scheduled to enter first-in-human studies in the fourth quarter of 2007.

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Ardea's goals, including its goal of initiating clinical studies on four compounds this year, the initiation of a program to evaluate RDEA119 in inflammatory diseases and its 2007 year-end cash projection. Risks that contribute to the uncertain nature of the forward-looking statements include: risks related to the outcomes of preclinical and clinical trials, risks related to regulatory approvals, delays in commencement of preclinical and clinical tests, and costs associated with internal development and in-licensing activities. These and other risks and uncertainties are described more fully in Ardea's most recently filed SEC documents, including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, under the headings "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. Ardea undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

ARDEA BIOSCIENCES, INC.

(formerly IntraBiotics Pharmaceuticals, Inc)

CONDENSED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(Unaudited)

Three Months Ended Nine Months Ended

September 30, September 30,

2007 2006 2007 2006

Sponsored Research Revenue $1,077 $- $2,827 $-

Operating expenses:

Research and development 7,114 - 15,843 7

General and administrative 1,785 463 4,913 1,677

Total operating expenses 8,899 463 20,756 1,684

Operating loss: (7,822) (463) (17,929) (1,684)

Interest income 509 635 1,688 1,731

Other income, net 4 4 188 2

Net income (loss) (7,309) 176 (16,053) 49

Non-cash dividends on Series A

preferred stock (60) (60) (180) (180)

Net income/(loss) applicable to

common stockholders $(7,369) $116 $(16,233) $(131)

Basic net income/(loss) per

share applicable to common

stockholders $(0.72) $0.01 $(1.67) $(0.01)

Diluted net income/(loss) per

share applicable to common

stockholders $(0.72) $0.01 $(1.67) $(0.01)

Weighted average shares used to

compute basic net

income/(loss) per share applicable

to common stockholders 10,182 9,334 9,716 9,316

Weighted average shares used to

compute diluted net income/(loss)

per share applicable to common

stockholders 10,182 11,560 9,716 9,316

The accompanying notes are an integral part of these financial statements.

Condensed Balance Sheet Data

(In thousands)

September 30, December 31,

2007 2006

Cash, cash equivalents and

short-term investments $35,586 $48,669

Total assets $37,801 $50,240

Total stockholders' equity $34,620 $49,064


'/>"/>
SOURCE Ardea Biosciences, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related biology technology :

1. Selection of Development Candidate Triggers $0.5 Million Milestone Payment to Ardea Biosciences, Inc.
2. Ardea Biosciences Announces Changes to Research Management
3. ONCOSCIENCE AG, THE EUROPEAN PARTNER OF YM BIOSCIENCES, ANNOUNCES COMPLETION OF PATIENT ENROLLMENT IN PHASE III BRAIN CANCER TRIAL OF NIMOTUZUMAB
4. Pressure BioSciences, Inc. Reports Second Quarter 2007 Financial Results and Provides Business Update
5. Pressure BioSciences, Inc. Issued First Patent in Canada
6. Pressure BioSciences, Inc. Announces CE Mark Approval and Compliance with the IEC 61010-1 Standard for a Second PCT-based Instrument, the Barocycler NEP2320
7. Founder of ILEX Oncology and Triton Biosciences, Richard Love, Joins Board of Directors of Cell Therapeutics, Inc. (CTI)
8. Pressure BioSciences, Inc. Provides Corporate Update
9. EpiCept Reports Expansion of Clinical Development For Licensed Cancer Compound
10. QMed, Inc. Reports July Medicare SNP Enrollments
11. Phlo Affiliate Reports Expanded Coverage to Oregon Border
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... -- ContraVir Pharmaceuticals, Inc. (NASDAQ: CTRV ), a ... targeted antiviral therapies, announced today that it will present ... held February 8-9, 2016, at the Waldorf Astoria New ... Healthcare Conference, taking place in New York ... Sapirstein , Chief Executive Officer of ContraVir, will provide ...
(Date:2/4/2016)... Brooklyn, NY (PRWEB) , ... February 04, 2016 , ... ... cuvettes for over 10 years. What sets them apart from other cuvette ... that is posted on their website. On top of this steady flow of ...
(Date:2/3/2016)... and HOLLISTON, Mass., Feb. 3, 2016 Harvard ... a biotechnology company developing bioengineered organ implants for ... today announced that CEO Jim McGorry , ... Investor Conference on Tuesday, February 9, 2016 ... York City . HART,s presentation will be ...
(Date:2/3/2016)... , ... February 03, 2016 , ... ... annual report which summarizes and analyzes nearly 750 unique supply chain ... alert, and analysis service. , Supply chain risk management practitioners subscribe to ...
Breaking Biology Technology:
(Date:1/18/2016)... 2016  Extenua Inc., a pioneering developer of ... and access of ubiquitous on-premise and cloud storage, today ... Cyber.  ... C4ISR and Cyber initiatives in support of National ... technology solutions," said Steve Visconti , Extenua ...
(Date:1/11/2016)...  higi, the leading retail and omni-channel community engagement ... and mobile, today announced it has closed funding ... --> --> ... higi,s health platform – its network of health ... expanding services and programs to retail partners and ...
(Date:1/7/2016)... , Jan. 7, 2016  A United States ... the first court in the country to interpret a ... lawsuit to go forward against the photo website Shutterfly ... BRIAN NORBERG vs. SHUTTERFLY, INC.; and ... plaintiff alleges that Shutterfly violates the Illinois Biometric Privacy ...
Breaking Biology News(10 mins):