Replies to post #65256 on Biotech Values

[DewDiligence]

RDEA Reports 3Q08 Results

[This PR came out this morning and is presumably not the cause of the stock’s spike to a 42% gain in the closing minutes today. The cash balance as of 9/30/08 was $29.5M and another $8M was raised today, as described in a separate PR. RDEA does not hold quarterly CC’s. Please see actual PR for financial tables.]

http://biz.yahoo.com/bw/081113/20081113005382.html

›Thursday November 13, 8:30 am ET

SAN DIEGO--(BUSINESS WIRE)--Ardea Biosciences, Inc. (Nasdaq: RDEA ), a biotechnology company focused on the discovery and development of small-molecule therapeutics for the treatment of human immunodeficiency virus (HIV), gout, cancer and inflammatory diseases, today reported on recent accomplishments and financial results for the three and nine months ended September 30, 2008.

“We have continued to make significant progress since providing our second quarter 2008 update. In August, we initiated a Phase 1 study in normal healthy volunteers of RDEA594, our lead product candidate for the treatment of hyperuricemia and gout, and recently reported positive preliminary results from that trial, including a significant increase in urinary excretion of uric acid, confirming that RDEA594 is responsible for the uric acid-lowering effects observed in previous clinical studies of its prodrug, RDEA806,” commented Barry D. Quart, PharmD, Ardea’s president and chief executive officer.

“We have also taken steps to extend our operating runway into the second half of 2009 by securing an $8.0 million growth capital loan and by delaying the onset of certain clinical studies related to programs that are subject to ongoing partnering discussions,” [this was announced in a separate PR this morning] added Dr. Quart.

Recent Accomplishments

Gout

* Presented preliminary data from a Phase 1 single ascending dose study of RDEA594 in healthy volunteers demonstrating a favorable pharmacokinetic profile with low systemic clearance, favorable absorption, a half-life supporting once-daily dosing, and a significant increase in urinary excretion of uric acid, at the 2008 American College of Rheumatology (ACR) / Association of Rheumatology Health Professionals (ARHP) Annual Scientific Meeting in San Francisco, California.

HIV

* Received regulatory approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom to conduct a Phase 2b study comparing RDEA806 to efavirenz (SUSTIVA®/Stocrin®, Bristol-Myers Squibb and Merck & Co.) in anti-retroviral treatment naïve patients without transmitted resistance receiving background treatment with Truvada® (Gilead Sciences). We expect to dose the first patient in this study in 2009; and

* Presented data from a Phase 2a study of RDEA806 demonstrating robust antiviral activity with a well-tolerated safety profile [#msg-31315602] and confirming its low potential for drug interactions, as well as preliminary data from a Phase 1 drug-drug interaction study of RDEA806 and Truvada showing no interaction with either of its components (emtricitabine or tenofovir disoproxil fumarate), and preclinical virology data showing that RDEA806 has a high genetic barrier to resistance and limited cross-resistance to other NNRTIs, at the 48th Annual American Society for Microbiology’s Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) / Infectious Diseases Society of America (IDSA) 46th Annual Meeting in Washington, DC.

Cancer

* Initiated a Phase 1/2 study of RDEA119 in combination with sorafenib (Nexavar®, Onyx Pharmaceuticals and Bayer HealthCare) in advanced cancer patients;

* Presented data from an ongoing Phase 1 study of RDEA119 in patients with advanced cancer at the second annual meeting on Molecular Markers in Cancer, hosted by the American Society of Clinical Oncology (ASCO), National Cancer Institute (NCI), and European Organisation for Research and Treatment of Cancer (EORTC) in Hollywood, Florida; and

* Presented preclinical data for RDEA119 demonstrating synergistic activity when used in combination with other anti-cancer agents (including sorafenib) in multiple tumor types at the EORTC / NCI / American Association for Cancer Research (AACR) symposium on 'Molecular Targets and Cancer Therapeutics' in Geneva, Switzerland.

Inflammation

* Presented preclinical data for RDEA119 demonstrating a favorable anti-inflammatory profile in animal models of chronic ulcerative colitis at the American College of Gastroenterology (ACG) Annual Meeting in Orlando, Florida; and

* Presented preclinical data for RDEA119 demonstrating its ability to significantly inhibit production of inflammatory cytokines in human and animal cellular models of gouty arthritis at the 2008 ACR / ARHP Annual Scientific Meeting in San Francisco, California.

Financial

* Received an $8.0 million growth capital loan from Oxford Finance Corporation and Silicon Valley Bank which, together with our existing cash reserves, provides greater flexibility in ongoing partnering discussions and funds our operating activities into the second half of 2009.

Upcoming Clinical Development Milestones

Gout

* Complete our ongoing single ascending dose Phase 1 study of RDEA594 in normal healthy volunteers in the fourth quarter of 2008;

* Complete a multiple ascending dose Phase 1 study of RDEA594 in normal healthy volunteers in the first quarter of 2009;

* Initiate a Phase 2 study of RDEA594 in gout patients in the first half of 2009, with the goal of completing the Phase 2 study by the end of 2009; and

* Complete our ongoing Phase 2a study of RDEA806 in gout patients in the first quarter of 2009.

HIV

* Initiate a Phase 1 study of RDEA427, our second-generation NNRTI for the treatment of HIV, in normal healthy volunteers in the first quarter of 2009.


Inflammation

* File an Investigational New Drug Application (IND) or Clinical Trial Application Authorization (CTA) in the fourth quarter of 2008 and initiate a Phase 1 study of RDEA436 evaluating safety, pharmacokinetics and inflammatory disease biomarkers in healthy volunteers in the first quarter of 2009; and

* Initiate a Phase 2a study of RDEA119 or RDEA436 in patients with inflammatory disease in the first half of 2009.

Third Quarter and Year-to-Date 2008 Financial Results

As of September 30, 2008, we had $29.5 million in cash, cash equivalents and short-term investments, compared to $66.2 million as of December 31, 2007. Our September 30, 2008 cash balance does not include the proceeds from our $8.0 million growth capital loan received in early November 2008. The $36.7 million decrease in cash, cash equivalents and short-term investments for the first nine months of 2008 was due to the use of cash to fund our clinical and preclinical programs, increased personnel costs and for other general corporate purposes.

The net loss applicable to common stockholders for the three and nine months ended September 30, 2008 was $14.2 million and $42.4 million, or $0.95 per share and $2.98 per share, respectively, compared to a net loss applicable to common stockholders for the same periods in 2007 of $7.4 million and $16.2 million, or $0.72 per share and $1.67 per share, respectively. The net loss applicable to common stockholders for the three and nine months ended September 30, 2008 included non-cash charges of $1.3 million and $3.7 million, or $0.09 per share and $0.26 per share, respectively, for stock-based compensation expense. For the same periods in 2007, we reported non-cash charges of $0.4 million and $0.8 million, or $0.04 per share and $0.08 per share, respectively, for stock-based compensation expense. The increase in net loss applicable to common stockholders and net loss applicable to common stockholders per share between these periods was primarily due to increased research and development expenses related to the continued development and progression of our clinical and preclinical programs, increased general and administrative expenses to support that effort and our overall growth.

There were no revenues for the three months ended September 30, 2008. Revenue for the nine months ended September 30, 2008 was $0.3 million, compared to $1.1 million and $2.8 million for the three and nine months ended September 30, 2007, respectively. Historically, our revenues have resulted from the research services we provide under our master services agreement with Valeant Research and Development, Inc. (Valeant). The decrease in revenues from 2007 levels is due to the earlier than anticipated identification of a clinical development candidate from that program and Valeant’s subsequent reduction in the utilization of our research and development services.

About Ardea Biosciences, Inc.

Ardea Biosciences, Inc., of San Diego, California, is a biotechnology company focused on the discovery and development of small-molecule therapeutics for the treatment of HIV, gout, cancer and inflammatory diseases. We have five product candidates in clinical trials and others in preclinical development and discovery. Our most advanced product candidate is RDEA806, an NNRTI, which has successfully completed a Phase 2a study for the treatment of patients with HIV. We have evaluated our second-generation NNRTI for the treatment of HIV, RDEA427, in a human micro-dose pharmacokinetic study and have selected it for clinical development. RDEA594, our lead product candidate for the treatment of hyperuricemia and gout, is being evaluated in a Phase 1 clinical trial and is believed to be an inhibitor of the URAT1 transporter in the kidney, which is responsible for regulation of uric acid levels. We are evaluating our lead MEK inhibitor, RDEA119, in a Phase 1/2 study in combination with sorafenib (Nexavar®, Onyx Pharmaceuticals, Bayer HealthCare) and as a single agent in a Phase 1 study, both in advanced cancer patients, and have completed a Phase 1 study in normal healthy volunteers as a precursor to trials in patients with inflammatory diseases. Lastly, we have evaluated our second-generation MEK inhibitor for the treatment of cancer and inflammatory diseases, RDEA436, in a human micro-dose pharmacokinetic study and have selected it for clinical development.‹

[DewDiligence]

IDIX and RDEA each closed +19% on no news. These two stocks have often moved in unison lately, which is not crazy given that they have similar drug candidates in HIV.

[DewDiligence]

IDIX – Revealing tidbits from RDEA’s Piper Jaffray webcast:

During a barrage of uncommonly persistent questioning by PJ analyst Thomas Wei, RDEA’s CEO, Barry Quart, conceded that IDX899 is the one competitor to RDEA806 in the HIV/NNRTI arena that he is seriously concerned about.

Quart dismissed TMC278 from JNJ for its lack of potency, and he hinted that UK 453,061 from PFE may have been shunted to the back burner. (I reached more or less the same conclusion on PFE’s drug—see the prologue comments in #msg-26610262).

When the discussion turned to IDIX’s IDX899, Quart could not find anything negative to say about it! All he could muster in support of his own company’s drug is that RDEA806 has been tested in more people to date, which is true—barely.

Turning to the RDEA806 program itself, Quart publicly acknowledged for the first time that the start of the phase-2b trial, which was announced in October (#msg-33138650), will be delayed for an unspecified period so that RDEA can solicit input from prospective partners.

What does all this mean for IDIX? What we know is that both IDX899 and RDEA806 are fine drugs (#msg-31380545), both aim to supersede Sustiva as the NNRTI of choice in SoC HIV cocktails, both have completed phase-2a, and both are ready for partnering. It will be interesting to see which drug garners a more lucrative deal.