Navigation Links
Ardea Biosciences Reports Progress of Clinical Development Programs; Provides 2008 Outlook; Announces 2007 Financial Results and Provides 2008 Financial Guidance
Date:3/24/2008

SAN DIEGO, March 24 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA), a company focused on the discovery and development of small- molecule therapeutics for the treatment of HIV, cancer and inflammatory diseases, including gout, today reported significant accomplishments in 2007, provided key milestones in 2008 for its clinical development programs, announced 2007 fourth quarter and full-year financial results and provided financial guidance for 2008.

"During 2007, we made significant strides in establishing a solid corporate foundation on which our future successes will be built," said Barry D. Quart, PharmD, Ardea Biosciences' President and CEO. "We assembled a proven management team and a group of key expert advisors; we added depth to our pipeline through the discovery of an exciting new product opportunity in gout; and we continued to make progress with our HIV, cancer and inflammatory disease programs."

Recent Accomplishments

-- Reported positive preliminary data from a Phase 2a proof-of-concept

trial of RDEA806 in patients with HIV;

-- Initiated a new clinical development program, stemming from our

RDEA806 research, directed toward the treatment of gout;

-- Initiated a Phase 1 trial of RDEA119 in patients with advanced cancer;

-- Completed a first-in-human micro-dosing study of RDEA436, a second

generation MEK inhibitor for the treatment of cancer and inflammatory

diseases and, based on an encouraging pharmacokinetic profile,

nominated it as a development candidate;

-- Completed a $40 million private placement;

-- Established two scientific advisory boards to guide the inflammatory

disease and HIV programs;

-- Presented preclinical data demonstrating potent activity and favorable

resistance profiles for our non-nucleoside reverse transcriptase

inhibitor (NNRTI) family of compounds against HIV at the 15th Annual

Conference on Retroviruses and Opportunistic Infections (CROI);

-- Presented favorable anti-tumor preclinical data on RDEA119 at the 2007

AACR-NCI-EORTC International Conference on Molecular Targets and

Cancer Therapeutics; and

-- Relocated our corporate headquarters and research laboratories to San

Diego's biotechnology corridor.

2008 Anticipated Key Program Milestones

In 2008, Ardea anticipates accomplishing the following milestones:

HIV

-- Initiate a Phase 2b trial of RDEA806 in patients with HIV in the

second quarter of 2008;

-- Complete a first-in-human micro-dosing study of our second generation

NNRTI, RDEA427, in the first quarter of 2008;

-- Initiate a Phase 1 trial of RDEA427 in the second half of 2008; and

-- Present the full results of our Phase 2a proof-of-concept study of

RDEA806 at a scientific conference in the second half of 2008.

Gout/Inflammation

-- Initiate a Phase 2 dose-finding trial for the treatment of gout in

the second quarter of 2008 with results expected in the second half

of 2008; and

-- Initiate a Phase 2a trial with RDEA119 for the treatment of

inflammatory disease in the second quarter of 2008.

Cancer

-- Complete and report data from the Phase 1 trial of RDEA119 in

patients with advanced cancer in the second half of 2008;

-- Initiate Phase 2 trials of RDEA119 in combination with other anti

cancer agents in the second half of 2008; and

-- Initiate a Phase 1 trial of our second generation MEK inhibitor in

the second half of 2008.

2007 Financial Results

Ardea's 2007 year-end cash balance was $66.2 million, compared to $48.7 million for the 2006 year-end cash balance. The December 31, 2007 cash balance includes net proceeds of $37.2 million from a private placement of common stock in December 2007.

The net loss for the fourth quarter 2007 was $9.1 million, or $0.86 per share, compared to a net loss for the same period in 2006 of $0.5 million, or $0.05 per share. The net loss for the year ended December 31, 2007 was $25.3 million, or $2.55 per share, compared to a net loss for the year ended December 31, 2006 of $0.6 million, or $0.07 per share. The net loss for the quarter and full-year ended December 31, 2007 included non-cash stock-based compensation expense of $0.6 million, or $0.05 per share, and $1.4 million, or $0.14 per share, respectively. The difference between the Company's 2007 and 2006 results reflects the rebuilding of its operations combined with the advancement and expansion of its preclinical and clinical drug development programs.

Revenues for the fourth quarter of 2007 were $0.3 million, compared to zero for the same period in 2006. Revenues for the full-year 2007 were $3.1 million compared to zero for 2006. The increase is due to research performed by the Company as part of a master services agreement with Valeant.

2008 Financial Guidance

On December 31, 2007, the Company had a total of $66.2 million in cash, cash equivalents and short-term investments. Excluding any funds that Ardea may receive from future business development activities, the Company anticipates 2008 net cash usage to be between $45 million and $50 million.

About Ardea Biosciences

Ardea Biosciences, of San Diego, California, is a biotechnology company focused on the discovery and development of small-molecule therapeutics for the treatment of HIV, cancer and inflammatory diseases, including gout. We have three drug candidates in clinical trials and several others in preclinical development and discovery. Our most advanced drug candidate is RDEA806, a non-nucleoside reverse transcriptase inhibitor (NNRTI), which is in a Phase 2a study for the treatment of HIV. We are also investigating RDEA806 for the treatment of gout. Our lead mitogen-activated ERK kinase (MEK) inhibitor, RDEA119, is in a Phase 1 study in advanced cancer patients and is being investigated for the treatment of inflammatory diseases. RDEA436, our second generation MEK inhibitor for the treatment of cancer and inflammatory diseases, has been evaluated in a human micro-dose pharmacokinetic study and has been selected as a development candidate. In addition to the foregoing clinical programs, we are developing a second generation NNRTI for HIV, as well as other drug candidates in earlier stages of preclinical development and discovery.

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: sufficiency of cash resources and our goals, including the expected properties and benefits of RDEA806, RDEA119, RDEA427, RDEA436 and our other compounds and the results of preclinical, clinical and other studies. Risks that contribute to the uncertain nature of the forward-looking statements include: risks related to the outcome of preclinical and clinical studies, risks related to regulatory approvals, delays in commencement of preclinical and clinical studies, and costs associated with internal development and in-licensing activities. These and other risks and uncertainties are described more fully in our most recently filed SEC documents, including our Annual Report on Form 10-K and our 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. We undertake 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 data)

Three Months Twelve Months

Ended Ended

December 31 December 31

2007 2006 2007 2006

Collaboration Revenues $268 $- $3,095 $-

Operating Expenses:

Research and Development $7,260 $65 $23,103 $72

General and Administrative 2,653 997 7,566 2,674

Total Operating Expenses 9,913 1,062 30,669 2,746

-

Operating Loss: (9,645) (1,062) (27,574) (2,746)

Interest Income 440 646 2,128 2,377

Other Income (expense), net 187 0 375 2

Net income/(loss) applicable to common

stockholders $(9,018) $(416) $(25,071) $(367)

Non-cash dividends on Series A

Preferred stock (60) (60) (240) (240)

Net loss applicable to common

shareholders $(9,078) $(476) $(25,311) $(607)

Basic and diluted net loss per share

applicable to common stockholders $(0.86) $(0.05) $(2.55) $(0.07)

Shares used to compute basic and

diluted net loss per share applicable

to common stockholders 10,583 9,358 9,934 9,326

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

Condensed Balance Sheet Data

(In Thousands)

December 31 December 31

2007 2006

Cash, cash equivalents and short-term

investments 66,215 48,669

Total assets 67,649 50,240

Total stockholders' equity 63,739 49,064


'/>"/>
SOURCE Ardea Biosciences, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Ardea Biosciences Lead NNRTI for HIV, RDEA806, to Enter Phase 2a Proof-of- Concept Clinical Trial
2. Pressure BioSciences, Inc. Reports 2007 Financial Results and Provides Business Update
3. Pressure BioSciences, Inc. Announces Move to New Corporate Offices
4. Numira Biosciences Names New Board Member
5. DARA BioSciences, Inc. Announces Appointment of Dr. David J. Drutz to Board
6. DARA BioSciences, Inc. and Point Therapeutics, Inc. Announce Consummation of Merger
7. Summary Notice of Proposed Settlement and Settlement Hearing in Re Martek Biosciences Corp., Securities Litigation
8. Sangamo BioSciences Provides Update on Companys Accomplishments in 2007 and 2008 Objectives
9. Regado Biosciences to Present at 19th Annual Piper Jaffray Health Care Conference
10. Schering-Plough Receives Clearance From U.S. Federal Trade Commission for Planned Acquisition of Organon Biosciences N.V.
11. Pressure BioSciences, Inc. Reports Third Quarter 2007 Financial Results and Provides Business Update
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2016)... ... 2016 , ... There are nearly 14.5 million people living with and beyond ... Sunday, June 5, 2016, communities around the world will gather to recognize these cancer ... Cancer Survivors Day® is an annual worldwide Celebration of Life that is held on ...
(Date:5/26/2016)... Los Angeles, CA (PRWEB) , ... May 26, 2016 , ... In an effort to ... Snapchat videos available to both Snapchat users and those who do not use the app. ... available on his new page, Dr. Mohebi Live . , Dr. Mohebi says, ...
(Date:5/26/2016)... (PRWEB) , ... May 26, 2016 , ... North ... May 13 at Blackhorse Golf Club in Cypress. With the help of community partners, ... that restores, empowers, and renews hope for wounded service members and their families through ...
(Date:5/26/2016)... ... May 26, 2016 , ... Power Systems, a leading developer ... Instructor Certification Course in Stoughton, Massachusetts. The course was led by Power Systems’ ... 8 hour interactive course to qualify participants as certified PowerWave trainers. , ...
(Date:5/26/2016)... ... May 26, 2016 , ... The introduction of our professional athletes coincides with ... ™”. , “We are proud to introduce Meghan Klingenberg, defender and World ... Brian Quick, wide receiver for Los Angeles who was a second round selection in ...
Breaking Medicine News(10 mins):
(Date:5/25/2016)... , May 25, 2016  According to Kalorama ... $381 billion in 2015.  Though these are challenging ... of opportunity for success for companies that remain ... search of new growth prospects medical device companies ... research and development (R&D) than do companies in ...
(Date:5/25/2016)... 25, 2016 As illustrated by ... this month, the numbers and momentum of cannabis in ... into the billions, more research and development push the ... State of Legal Marijuana Markets Report  from from ArcView ... much of the increase in sector is attributed to ...
(Date:5/25/2016)... May 25, 2016 Digital Health Dialog, ... it by the US Patent and Trademark Office ... includes proprietary processes for electronic opt-­in and processing ... wellness programs, HIPAA compliance and otherwise. ... "Our technology allows for individuals ...
Breaking Medicine Technology: