Replies to post #81677 on Biotech Values

[DewDiligence]

ANDS addendum: I thought it was sneaky of the company to withhold from today’s PR that patients in the 400mg arm will not be treated until patients in the 200mg arm have been evaluated for rash and other AE’s. They did mention this design feature on today’s CC—but only because someone asked about it.

I suppose investors could have ascertained the delayed start of the 400mg arm by reading between the lines in the PR:

Anadys expects to receive 28-day safety and response (RVR) data from the 200 mg dose level by year-end and additional on-treatment safety and response data from both cohorts during the first two quarters of 2010.

Since the duration of treatment in the two arms is the same, the only possible reason for the 200mg results to be available sooner in a randomized trial such as this one is that the start of dosing in the 400mg arm is being delayed. Still, investors should not have to work this hard to obtain such an important piece of information and ANDS deserves low marks on transparency.

[DewDiligence]

ANDS Reports 2Q09 Results

[The big news today was in ANDS’ other PR about the ANA598 phase-2 program (#msg-40064675, #msg-40065354). There’s nothing of consequence in the PR in this post except that the cash balance at 6/30/09 was $30.6M. This balance should last a while because ANDS laid off 40% of its staff and terminated the ANA773 program in June (#msg-38418158).]

http://finance.yahoo.com/news/Anadys-Pharmaceuticals-prnews-3600374889.html?x=0&.v=1

›Cash Reserves Augmented with Recently Completed Financing Expected to Fund Operations into 2011

Thursday July 30, 2009, 4:10 pm EDT

SAN DIEGO, July 30 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS ), a biopharmaceutical company dedicated to improving patient care by developing novel medicines for the treatment of hepatitis C, today reported its financial results and program highlights for the second quarter ended June 30, 2009.

"With our enhanced cash position, reduced cost structure and Phase II protocol allowance from the FDA, we are well positioned to continue advancing the development of ANA598 as a treatment for chronic hepatitis C," said Steve Worland, Ph.D., President and CEO of Anadys. "ANA598 has demonstrated potent antiviral activity and good tolerability in Phase I, as well as preclinical properties indicative of likely synergy when used clinically in combination regimens. The upcoming Phase II trial has several important elements, including twelve weeks of ANA598 combination treatment and a randomized exploration of shortening the overall duration of HCV therapy in conjunction with ANA598 treatment. We look forward to receiving the first data from this trial by year-end 2009 and additional data in the first half of 2010."

Financial Results

As of June 30, 2009, the Company's cash, cash equivalents and securities available-for-sale totaled $30.6 million compared to $27.9 million as of December 31, 2008. The increase in cash, cash equivalents and securities available-for-sale is the result of proceeds received from a "registered direct" offering of common stock and warrants in early June 2009, partially offset by the year-to-date cash utilization.

Research and development expenses were $4.6 million for the second quarter of 2009, compared to $5.5 million for the second quarter of 2008. The $0.9 million decrease was primarily attributable to a $1.3 million decrease in ANA773 development costs partially offset by $0.5 million in severance costs recorded in conjunction with the strategic restructuring initiated in June 2009. ANA773 development costs during the second quarter of 2009 were primarily driven by the ongoing Phase I clinical trial for the treatment of hepatitis C. During the second quarter of 2008, ANA773 development costs were primarily driven by the now completed 13-week GLP animal toxicology studies and the Phase I oncology clinical trial. The ANA598 development costs during the second quarter of 2009 were primarily associated with the 14-day healthy volunteer study and the ongoing long-term chronic toxicology studies which were initiated in September 2008.

General and administrative expenses were $2.5 million for the second quarter of 2009, compared to $2.0 million for the second quarter of 2008. The $0.5 million increase primarily resulted from severance costs recorded in conjunction with the strategic restructuring initiated in June 2009.

Operating expenses were $7.2 million for the second quarter of 2009, compared to $7.5 million for the second quarter of 2008. Included as a component of Anadys' operating expenses were non-cash, share-based expenses of $1.1 million and $0.7 million for the second quarter of 2009 and 2008, respectively.

The net loss was $6.5 million for the second quarter of 2009, compared to a net loss of $7.1 million for the second quarter of 2008. Included in the net loss for the second quarter of 2009 is a $0.4 million gain resulting from a reduction between issuance and June 30, 2009 in the liability associated with common stock warrants issued in conjunction with the "registered direct" financing. Basic and diluted net loss per common share was $0.21 in the second quarter of 2009, compared to $0.25 in the second quarter of 2008. Non-cash share-based expense resulted in a $0.03 and $0.02 increase in basic and diluted net loss per share for the second quarter of 2009 and 2008, respectively.

For the six months ended June 30, 2009, Anadys reported a net loss of $15.3 million, compared to $14.5 million for the same period last year. Basic and diluted net loss per common share was $0.51 for the six months ended June 30, 2009 and 2008.

Operational Highlights

* Closed Registered Direct Financing. In early June, Anadys closed a "registered direct" offering through the sale of units to institutional investors, with each unit consisting of one share of common stock and a warrant to purchase 0.35 of a share of common stock. $17.5 million in gross proceeds were raised, with net proceeds of approximately $16.0 million, after deducting placement agent fees and estimated offering expenses. Proceeds from the transaction are being used to further the development of ANA598, as well as for other general corporate purposes.

* Future Operations to Focus on Development of ANA598. In June, Anadys initiated a strategic restructuring to focus its operations on the continued development of ANA598, in particular a Phase II study in combination with pegylated interferon-alpha and ribavirin. The restructuring included a reduction in Anadys' workforce expected to generate annual savings of $4 to $5 million, while retaining the clinical development infrastructure required to conduct the Phase II study of ANA598, key capabilities directed toward pharmaceutical development and next generation non-nucleosides, and a streamlined administrative staff. Also included in the restructuring is an expected reduction in annual facility expense of approximately $1.8M associated with our completed move to a smaller facility.

Development Program Highlights

ANA598 is the Company's non-nucleoside HCV polymerase inhibitor.

* Finalization of ANA598 Phase II Protocol. Anadys has finalized its protocol and received FDA clearance for the Phase II study of ANA598 in combination with pegylated interferon-alpha and ribavirin for the treatment of chronic hepatitis C. In the Phase II study, naive genotype 1 patients will receive ANA598 or placebo in combination with Pegasys® (peginterferon alfa-2a) and Copegus® (ribavirin, USP) (a current standard of care, or SOC) for 12 weeks at dose levels of 200 mg or 400 mg twice daily (bid), each with a loading dose of 800 mg bid on day one. After week 12, patients will continue to receive SOC alone. Patients who have undetectable levels of virus at weeks 4 and 12 will be randomized to stop all treatment at either week 24 or 48. The primary endpoint of the study is the proportion of patients who achieve undetectable levels of virus at week 12 (complete Early Virological Response or cEVR). Response at week 4 will also be assessed to provide the rate of Rapid Virological Response, or RVR. Patients will be followed for 24 weeks after stopping therapy to determine the rate of Sustained Virological Response, or SVR. Ninety patients are planned to be enrolled in this study - thirty patients receiving ANA598 and fifteen receiving placebo at each dose level. The study will be conducted at a number of clinical sites in the United States. Patient dosing in the trial is expected to commence in the next several weeks. Anadys expects to receive RVR data from the 200 mg dose group by year-end.

* Reported Potent Antiviral Activity/Good Tolerability in HCV at EASL. In April 2009, data demonstrating potent antiviral activity and good tolerability of ANA598 as a single agent at all dose levels in a Phase Ib study in HCV patients were reported at the EASL conference. The median viral load reduction over three days ranged from 2.4 to 2.9 log10 in the three dose groups studied. No patient at any dose level showed evidence of viral rebound while on ANA598 and there were no serious adverse events.

* Reported 14-day Healthy Volunteer Study Results. In April 2009, Anadys reported results from a 14-day study of ANA598 in healthy volunteers. ANA598 was generally well-tolerated in all cohorts in the study with no serious adverse events. Three instances of mild-to-moderate rash were observed at the higher dose levels. Pharmacokinetic results from this trial confirmed the plasma half-life of ANA598 of approximately 24 hours, and demonstrated that steady-state levels of ANA598 in plasma are reached after six to seven days of dosing.

* Dosing Completed in Long-Term Chronic Toxicology Studies. The dosing period is completed in two long-term, chronic toxicology studies of ANA598 (26 weeks duration in rats and 39 weeks duration in monkeys). At the 13-week interim, the toxicology profile of ANA598 in both species was very favorable. While 39-week data from the monkey study is not yet available, a preliminary assessment of the results from the 26-week study in rats indicates a similar profile to that seen in rats at 13 weeks, in which the only adverse finding was a marginal decrease in the rate of weight gain in females at 1000 mg/kg, the highest dose tested. Complete results from both studies are expected at the end of the third quarter 2009.

ANA773 is the Company's oral inducer of endogenous interferons that acts via the toll like receptor 7 (TLR7) pathway.

[I omitted this section because the ANA773 program is defunct.]

…Webcast of Conference Call

Anadys will host a conference call at 5:00 pm Eastern Daylight Time today to discuss its second quarter 2009 financial results and highlights and to provide an update on its development programs. A live webcast of the call will be available online at www.anadyspharma.com. A telephone replay will also be available approximately one hour after completion of the call. To access the telephone replay, dial 888-286-8010 (domestic) or 617-801-6888 (international), passcode 85411914. The webcast and telephone replay will be available through August 13, 2009.‹

[mcbio]

ANDS - explanation for share rise

Can you help me understand the 80%+ rise in share price (at the time of this post) for ANDS today? So they got approval to do a longer Phase 2 study. Let's keep in mind that this is a study for which they could not garner a partner for given the safety issues that cropped up in the Phase 1b. How does just the fact that they got approval to run a longer trial have any bearing on the actual results of the trial? Isn't this just another case of Zebra's law where they have to run this trial because they have nothing left in the pipeline? The safety concerns are still there. As such, an 80% rise in share price seems perplexing.

[mcbio]

ANDS - Reports Phase 1 HCV data for ANA773

http://finance.yahoo.com/news/ANA773-Demonstrates-prnews-2460602176.html?x=0&.v=1

ANA773 Demonstrates Significant Antiviral Response in Early Clinical Trial in Hepatitis C Patients

Proof of Concept Achieved for Second Anadys HCV Product Candidate

SAN DIEGO, Aug. 11 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS - News) today announced viral load data for the final cohort of hepatitis C patients in a Phase I clinical trial of ANA773, the Company's oral inducer of endogenous interferons that acts via the toll-like receptor 7 (TLR7) pathway. In patients who received 2000 mg ANA773 every other day over 10 days, the mean (+/-SEM) maximal decline in viral load was 1.3 (+/-0.4) log10, compared to a mean maximal decline of 0.3 (+/-0.1) log10 in patients who received placebo (p=0.037). Five of the eight patients who received 2000 mg ANA773 experienced a maximal decline of greater than 1 log, while none of the eight patients who received placebo experienced a decline of greater than 1 log (p<0.001 for the proportion of patients with maximal response greater than 1 log compared to placebo). The mean end-of-treatment decline was 0.6 log10 in patients who received 2000 mg ANA773 compared to 0.1 log10 in patients who received placebo. ANA773 was well-tolerated in patients throughout the course of the study and there were no serious adverse events reported.

"ANA773 has demonstrated a significant short-term antiviral response in HCV patients, comparable to many historical reports of interferon as a single agent," commented Steve Worland, Ph.D., Anadys' President and CEO. "Given its oral delivery and favorable tolerability profile to date, we believe that ANA773 holds promise as a potential replacement for injectable interferon products in HCV therapy. We intend to seek partnership opportunities to continue advancing the development of ANA773, with the objective of creating well-tolerated, all oral combination regimens to treat hepatitis C."

James L. Freddo, M.D., Anadys' Senior Vice President, Drug Development and Chief Medical Officer added, "We are very encouraged by this data and the potential to further improve response by combining ANA773 with other agents, including ribavirin, an agent that improves response to interferon. Additionally, alternative dosing schedules may further improve pharmacological response to TLR7 activation, as was seen in preclinical studies of ANA773."

In an earlier cohort in which six patients received 1600 mg ANA773 every other day over 28 days, the mean (+/-SEM) maximal decline was 1.0 (+/-0.3) log10 (p>0.1 compared to placebo), with two patients experiencing a maximal decline of greater than 1 log during treatment. The mean end-of-treatment decline was 0.5 log10 at 1600 mg. Patients who received lower doses than 1600 mg showed correspondingly less antiviral response. The Company intends to present complete results from this study at the upcoming Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), Oct. 30 - Nov. 3 in Boston.

ANA773 Phase I Clinical Trial in HCV

The Phase I clinical trial of ANA773 in HCV was conducted in the Netherlands under a two-part protocol. Part A of the study included both single and multiple doses of ANA773 in healthy volunteers. Successive cohorts of volunteers received ascending dose levels of ANA773. The primary objectives of Part A of the study were to assess safety and tolerability. Full results from Part A of the study were presented at the EASL Conference in April of this year. In Part B of the study, HCV patients received ANA773 every other day for either 28 or 10 days. The primary objectives of Part B were to assess safety, tolerability and viral load decline. Doses initially explored in Part B of the study were 800 mg, 1200 mg, and 1600 mg dosed every other day for a period of 28 days. Based on the viral load data from the 1600 mg cohort, in April of this year Anadys amended the protocol to include a fourth cohort of HCV patients who received 2000 mg of ANA773 dosed every other day over a period of 10 days.

About ANA773 and TLR Pharmacology

ANA773 is the Company's oral inducer of endogenous interferons that acts via the toll like receptor 7 (TLR7) pathway. Results from preclinical pharmacology studies have shown that ANA773 can elicit desired immune responses and that the profile of response can be modulated by both dose and schedule of administration. Results of completed 13-week GLP toxicology studies have shown that with every-other-day dosing of ANA773, immune stimulation of a magnitude believed to confer therapeutic potential can be achieved without adverse toxicology findings. The immune stimulation observed with every-other-day dosing of ANA773 in preclinical studies included induction of interferon-alpha and interferon dependent responses at levels that are sustained over 13 weeks of dosing. Furthermore, dose-dependent stimulation of innate immune response in healthy volunteers was observed in Part A of the Phase I clinical trial with ANA773 (presented at EASL, 2009).

About Anadys

Anadys Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to improving patient care by developing novel medicines for the treatment of hepatitis C. The Company believes hepatitis C represents a large unmet medical need in which meaningful improvements in treatment outcomes may be attainable with the introduction of new medicines. The Company is developing ANA598, a non-nucleoside polymerase inhibitor for the treatment of hepatitis C. The Company has also investigated the potential of ANA773, an oral, small-molecule inducer of endogenous interferons that acts via the Toll-like receptor 7, or TLR7, pathway in hepatitis C.