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ANSV
Anesiva (formerly Corgentech)
conference date: November 9, 2006
for quarter ending: September 30, 2006 (3rd quarter)
Overview: No surprises except perhaps that the application to the FDA for Zingo will be made before the end of November.
Basic data:
No revenues, as expected. Operating expenses of $12.7 million including $2.6 million non-cash stock-based compensation.
Net loss of $11.9 million, or $0.59 per share.
Cash and equivalents ended at $57.7 million, down $9.4 million during the quarter.
Guidance:
Total net loss for 2006 will be $45 to $50 million, excluding non-cash stock-based compensation expense of $10 to $12 million.
Cash and equivalents will end between $35 million and $40 million.
Conference Highlights:
In addition to preparing the CTD/NDA (Common Technical Document / New Drug Application) with the FDA for Zingo(TM) (formerly 4268), they received orphan drug status for 4975 for interdigital neuroma and began a Phase I trial of 1207 topical anesthetic. Increased expenses are due to all these activities.
Successful pre-NDA meeting with FDA on Zingo. They plan to file CTD/NDA before the end of this month (November). Zingo could be launched by Q4 2007 if approved by FDA.
Marketing research on Zingo continues to be overwhelmingly positive. Fear of pain for children for IV placement and injections is widespread. 96% success with Zingo v. 75% success for non-Zingo for IV line placements.
In discussions with FDA on pathways for 4975. Planning Phase III clinical program. Talked extensively about Phase II trial for knee pain, which had very good results.
Q&A:
Final steps to filing CTD? Checking electronic linking in publication process.
Next steps? Preparing for manufacturing by obtaining automated equipment. Have been doing as much pre-marketing as they can.
4975 plan? Management of surgical pain is attractive, osteoarthritis would be another priority because of quality of data.
1207, pre-treatment with Lidocain? Ten minutes looks better than 5 minutes, does seem effective. Still collecting data on spacing of 1207 dosing.
Zingo analytical testing? Is a standard testing for releasing to clinic or commercial sales, and it is complete.
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Copyright 2006 William P. Meyers