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FY09 Net Loss Narrows, Opexa Therapeutics (NASDAQ: OPXA)

Opexa Therapeutics reported (3/5/10)  a net loss of $1.43 M or $0.11 per diluted share for FY09 compared to $11.85 M or $1.12 per diluted share in FY08.  FY09 highlights:

  • The pivotal point in the year was the completion of the stem cell transaction with Novartis (NYSE:NVS) Pharmaceuticals for an upfront payment of $3 M and potential technology transfer milestone payments totaling another $1 M (with total potential payments from the deal that could exceed $50 M),
  • Securing the 1st milestone payment from NVS related to the stem cell transaction of $0.5 M,
  • Completing the TERMS Phase IIb clinical study analysis, which demonstrated that Tovaxin is safe and well tolerated with promising efficacy across key clinical endpoints including Annualized Relapse Rate and disability (EDSS),
  • Closing 2 financings: $5.1 M in gross proceeds from a registered direct offering and $1.3 M in gross proceeds from a private placement of secured notes. 

OPXA reported NO revenues in FY09.  R&D expenses were $2,107,833 for 2009 (compared with $8,388,734 for 2008). The decrease in expenses was primarily due to a decrease in activities related to the Phase IIb clinical trial for Tovaxin which was completed in 2008, closing the extension trial, a reduction in staff and a reduction in stock compensation expense.  G&A expenses for 2009 were $2,020,572 (compared with $3,341,415 for 2008). The decrease in expense is due to a reduction in staff and a decrease in stock compensation expense, overhead expenses, professional service fees and board compensation fees. Interest expense was $278,127 for 2009 (compared with $19,983 for 2008).  Interest expense for FY09 was primarily related to accrued interest on the convertible notes, amortized interest on the convertible notes and the (non-cash) amortization of the financing fees over the life of the notes. Interest income was $1,764 for FY09 (compared with $100,235 for 2008).  The decrease was due to the reduction in cash balances that were available for investment in cash equivalent investments and a reduction in interest rates.  Gain on sale of assets was $3 M for FY09.  The gain is attributable to the sale of the stem cell technology program to NVS for an upfront payment of $3 M.  Other income for FY09 was $554,242 (compared with $34,901 for 2008). The increase in other income is primarily attributable to the receipt of an initial $500 K technology transfer fee milestone payment pursuant to the terms of the stem cell technology acquisition agreement with NVS.  Cash, cash equivalents and investments in marketable securities were $8,181,582 as of 12/31/09.

 OPXA close (3/9/10) at $1.99 with a market cap of $25.69 M.