Thallion Pharmaceuticals Inc. has announced its operational and financial results for the three-month and six-month periods ended May 31, 2011.
• Enrolled the first patients in the second cohort (high dose cohort) of the Phase II SHIGATEC trial evaluating Shigamabs® as a treatment for Shiga toxin-producing E. coli (STEC) infection.
• Subsequent to quarter-end, temporarily suspended screening and enrollment in the SHIGATEC study high dose cohort as a precautionary measure due to a preliminary product out-of-specification finding observed during routine long-term stability testing of its current anti-Stx1 monoclonal antibody clinical batch.
• Received positive recommendation from the Independent Data Monitoring Committee (IDMC). The IDMC completed a planned safety analysis of the first cohort of the targeted 21 patients and recommended the trial continue as per the protocol.
• Received shareholder approval to implement a Normal Course Issuer Bid which provides flexibility to the Company through an option to purchase shares in the open market, if, as and when the Board considers it in the best interests of the Corporation to do so.
"Although disappointed with the temporary suspension of screening and enrollment in the SHIGATEC study, we are also mindful that this situation is occurring during the seasonal low period for STEC infection in the southern hemisphere when the rate of patient recruitment is slower," said Dr. Allan Mandelzys, Thallion's Chief Executive Officer.
Dr. Mandelzys continued, "We remain absolutely committed to this core development program and ongoing clinical study, and we are doing everything possible to re-initiate patient enrollment in the most expeditious manner. As the recent devastating outbreak in Europe clearly demonstrates, the need for a viable treatment for Shiga toxin-producing E. coli (STEC) infections is an urgent one."
Collaboration and licensing revenues for the three-month and six-month periods ended May 31, 2011 were $1,021,034 and $1,854,916, respectively, compared to $1,011,316 for the three-month and $1,047,316 for the six-month periods ended May 31, 2010.
Revenue recognized in the first half of 2010 and 2011 is related to the development and license agreement signed with LFB in February 2010 for the Company's ongoing development of Shigamabs®.
Research and development expenses before tax credits (R&D) for the three-month and six-month periods ended May 31, 2011 were $1,085,332 and $2,246,195, a decrease of two percent from the three-month and six-month periods of 2010, $1,115,674 and $2,287,173 respectively.
R&D expenses remained relatively stable with the completion of substantially all activities related to the first cohort of the Phase II SHIGATEC trial and the second quarter initiation of patient enrollment in the second, high dose cohort of the trial, compared to the clinical, regulatory and CMC activities occurring in the second quarter of fiscal 2010.
General and administrative (G&A) expenses for the three-month and six-month periods ended May 31, 2011 were $666,079 and $1,278,653, respectively. G&A expenses decreased by 26 percent during the three-month period primarily due to reduced head office and lease related expenses as the part of the relocation of the Company's corporate headquarters.
G&A expenses decreased by 40 percent during the six-month period, after excluding one-time costs related to incentive bonuses and severance costs recorded in the first quarter of fiscal 2010.
The Company recorded a net loss of $797,908 or $0.02 per share in the three-month period ended May 31, 2011, compared with $841,219 or $0.03 per share in the corresponding period in 2010. For the six-month period ended May 31, 2011, the Company recorded a net loss of $1,816,674 or $0.06 per share, compared to $3,400,586 or $0.11 per share for the same period last year. The decrease in net loss is primarily due to higher collaboration and licensing revenues and a reduction in G&A expenses.
As at May 31, 2011, the Company's unrestricted cash position amounted to $7,902,827 which consists of cash and short-term investments. The Company's liquidity availability amounted to $8,527,063 compared with $10,981,096 on November 30, 2010.
The decrease in liquidity is primarily due to the reduction of accounts payable and accrued liabilities, in addition to cash expenses relating to operations for the first half of 2011 offset by Shigamabs® development funding received from LFB.
Furthermore, the Company's working capital amounted to $7,713,925 as at May 31, 2011 compared to $8,485,919 as at November 30, 2010, a decrease of $771,994 due primarily to activities related to the Company's first six months of operations.
As of July 13, 2011, Thallion had 32,194,566 common shares outstanding. The number of stock options and common share purchase warrants outstanding at July 13, 2011 were 2,871,950 and 530,000, respectively.