22 Sept.2004.
Investor Update
Extract:
the CV1 analgesic
"In 2003 the Company announced the in-licensing of ACV1 for the treatment of neuropathic (nerve) pain.
Progress has been excellent since the commencement of the ACV1 clinical development program in late 2003.
A preclinical animal toxicology package sufficient to support Phase 1 and early Phase 2 human clinical trials is well advanced and is scheduled to be completed by January 2005. The results of up to two weeks of repeat dosing in preliminary toxicity tests have been very favourable.
Other animal efficacy work contracted by Metabolic has also extended our knowledge of the range of activities of the compound, with encouraging pain relief obtained in several nerve injury models.
Dosing in Phase 1 human safety trials by subcutaneous injection is scheduled to begin in Q1 2005.
Planning for a NASDAQ listing
We believe that offering increased access to US investors will help Metabolic gain maximum value from positive results and place the Company in a strong position to negotiate with international pharmaceutical companies.
In addition to Metabolic's Australian Stock Exchange listing, steps are currently being taken to apply to the NASDAQ Stock Market and US Securities Exchange Commission to place existing Metabolic stock for trading in the US by way of a level 2 ADR (American Depository Receipts) listing.
This will only be activated in late 2004 if the Company's Phase 2B results are positive.
Upon subsequent initiation of a level 3 ADR listing, together with preparation of appropriate offer documentation, a future public capital raising will become possible in the US capital markets.
Financial Position
The Company currently has a strong cash position with more than $15 million in funds and expects to have approximately $11 million remaining at the time of the AOD9604 Phase 2B clinical trial outcome in late November.
In the event of a positive result, it is likely that further capital will be sought to expedite the AOD9604 development path while partnering discussions proceed".
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