Astex Pharmaceuticals, Inc. (NASDAQ:ASTX), the pharmaceutical company dedicated to discovering and developing novel small molecule therapeutics, just announced that it will release its 2012 first quarter financial results on Monday, April 30, 2012.
While it's not known if the company will surprise the market with any ground-moving financial news, James S.J. Manuso, PhD, chairman and chief executive officer of the firm, says that the company has an opportunity to "surprise investors with significant value creation" going forward in 2012.
While Manuso and the Astex Pharmaceuticals management team will provide details of the Company's financial results and any revised outlook for the future next week, we do know that it has been over 7 years since the firm raised money in the markets and that for 2012 financial performance, they were guiding to the achievement of approximate cash flow neutrality.
Last February, Astex shares got hammered after regulators turned a skeptical eye on a leukemia-related drug the company licensed to Eisai (ESALY.PK). More recently, the pharmaceutical company presented data on their novel, first-in-class, direct acting antiviral agent (DAA) against Hepatitis C Virus (HCV) at the 47th Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona.
Although quite technical, the posters below really showcase the strength of Astex's Pyramid technology to deliver promising new pipeline assets and highlight Astex's move into a new therapeutic area.
Poster 19057 [here in pdf form] explains the selection process of the preclinical candidates using Astex's industry-leading Pyramid fragment screening technology. The results are the identity of a new druggable binding site (clinically proven) on the serine protease of the Hep C virus, NS3, and the discovery of the two novel compounds.
Poster 19064 [here in pdf form] follows on from the previous poster, explaining the development process of the two compounds into preclinical candidates and their optimization with respect to human pharmacokinetics and improved potency. Key features of the design of these two compounds is the potential for once daily oral dosing and for their use in polytherapy regimes required for effective HCV treatment.
Given how hot stocks in the Hepatitis C Virus space have been on Wall Street, we reached out and asked CEO Manuso to walk us through some key questions about his firm and their platform:
Q: Astex is focused mainly on oncology and has a successful myelodysplastic syndrome (MDS) product in Dacogen (decitabine). What prompted this work into virology and specifically HCV?
Manuso: The Pyramid discovery platform is agnostic to indications and has been successfully used against targets from many therapeutic areas in partnerships with big pharma. HCV was targeted given the need for new anti-virals with novel mechanisms of action.
Q: Could you describe the benefits of your fragment-based Pyramid system and why it is suited to the development of the compound?
Manuso: Our discovery methodology allows us to find drugs against different target binding sites, such as allosteric pockets, compared with traditional high-throughput screening.
Q: What is it about AT26893 that distinguishes it from other direct acting antiviral agents (DAA) currently on the market or in development?
Manuso: Unlike other DAAs, AT26893 targets a novel binding site between the protease and helicase domains, and represents the first allosteric, non-competitive inhibitor of the NS3 protein which may confer a complementary clinical activity.
Q: AT26893 is in pre-clinical development now - when do you anticipate starting phase I trials?
Manuso: We have not given guidance on that timeline yet. The current status is preclinical.
Q: Astex has successfully partnered several of its pipeline assets with a number of companies, including GSK (GSK), Novartis (NVS), AstraZeneca (AZN) and Janssen. Are you looking for a partner for this asset?
Manuso: As data develops, we are discussing the possibility of partnering with appropriate companies.
Q: What are Astex's most important catalysts/milestones investors should be aware of this year?
Manuso: Dacogen EMA review of an AML submission by JNJ and four phase II data read outs in the fourth quarter.
Q: What are the biggest challenges for the company?
Manuso: Identifying the right biology that will result in addressing the unmet medical need we are targeting.
Q: What are the biggest opportunities?
Manuso: Surprising investors with significant value creation in 2012.