XOMA Corporation to Approve Amendments to Certificate of Incorporation
Apr 11 14
XOMA Corporation announced that the annual general meeting to be held on May 22, 2014, the board to approve an amendment to the Company's Certificate of Incorporation to increase the number of authorized shares of the company's common stock, par value $0.0075 per share, by an additional 138,666,666 to 277,333,332 shares.
XOMA Corporation Reports Consolidated Earnings Results for the Fourth Quarter and Full Year Ended December 31, 2013; Provides Cash Flow Guidance for the Year 2014
Mar 4 14
XOMA Corporation reported consolidated earnings results for the fourth quarter and full year ended December 31, 2013. For the quarter, the company's total revenues were $12,534,000 compared to $7,392,000 a year ago. Loss from operations was $15,580,000 compared to $12,619,000 a year ago. Net loss before taxes was $52,298,000 compared to net income before taxes of $2,365,000 a year ago. Net loss was $52,299,000 or $0.55 per basic and diluted share compared to net income of $2,365,000 or $0.03 per basic and diluted share a year ago. The increase in the fourth quarter and full-year 2013 Revenue was due primarily to the receipt of license and collaboration fees, which were offset by reductions in contract revenue and related expenses from NIAID government contracts and from reimbursements by Servier for gevokizumab-related activities. Excluding the non-cash revaluation of contingent warrant liabilities, the net loss for the three months ended December 31, 2013, was $17.0 million, or $0.18 per share.
For the year, the company's total revenues were $35,451,000 compared to $33,782,000 a year ago. Loss from operations was $58,205,000 compared to $56,624,000 a year ago. Net loss before taxes was $124,072,000 compared to $71,139,000 a year ago. Net loss was $124,058,000 or $1.43 per basic and diluted share compared to $71,065,000 or $1.10 per basic and diluted share a year ago. The full-year net losses in 2013 and 2012 included $61.0 million and $9.2 million, respectively, in non-cash revaluation of contingent warrant liabilities, which resulted primarily from the appreciation of company’s stock price. Excluding those revaluations, the net loss for 2013 was $63.0 million, or $0.72 per share, and the net loss for 2012 was $61.9 million, or $0.96 per share.
For the year 2014, the company anticipates cash used in ongoing operating activities during 2014 will be approximately $55.0 million to $60.0 million, primarily reflecting the costs associated with conducting the gevokizumab three Phase 3 clinical trials in the EYEGUARD program and the costs associated with conducting a Phase 3 clinical trial in patients with pyoderma gangrenosum.
XOMA Corporation Provides Update on Gevokizumab Proof-of-Concept Program
Mar 4 14
XOMA Corporation provided an update on its gevokizumab development program. Based on results from the company's Phase 2 program in patients with erosive osteoarthritis of the hand (EOA), XOMA does not intend to launch pivotal development for the broad EOA indication. The company will conduct a review of the full dataset to determine if there is a segment of the patient population that best responds to gevokizumab therapy prior to initiating any potential additional clinical studies in this indication. Gevokizumab appeared to be well tolerated, and the most common adverse events were comparable between both the gevokizumab and placebo groups. XOMA will continue to focus its efforts on completing the EYEGUARD(TM) Phase 3 clinical program, preparing to initiate its Phase 3 program in patients with pyoderma gangrenosum (PG), and assessing gevokizumab in pilot studies of other rare diseases that are in need of new therapeutic options. The company conducted two separate double-blind, placebo-controlled clinical studies in patients with EOA. The first study (Study 160) enrolled 85 patients who were diagnosed with EOA and who had a high-sensitivity C-reactive protein (CRP) level >=2.5 mg/L. CRP is recognized as a biomarker for generalized inflammation. The second study (Study 162) enrolled 92 patients who met the criteria for the first study but did not have elevated CRP. In both studies, patients were randomized 2:1 to receive either gevokizumab 60mg or placebo, dosed subcutaneously once monthly. Both studies were designed to determine if gevokizumab could improve the pain, stiffness, and physical function associated with EOA, based upon the Australian/Canadian Osteoarthritis Hand Index (AUSCAN(TM)) scoring scale. AUSCAN is a validated self-administered questionnaire specifically designed to assess the three dimensions of pain, disability, and joint stiffness of osteoarthritis of the hand using a series of 15 questions. Study 160 assessed the change in AUSCAN score from baseline at Days 84 and 168 in addition to assessing improvements of the effected joints from baseline using radiographic and MRI images taken at Days 84 and 168. Study 162 assessed the change in AUSCAN score from baseline at Day 84, the results in the second study did not show the same strength as the Day 84 results from Study 160. The initial results from Study 160 showed separation between the gevokizumab and placebo scores favoring gevokizumab over the 84-day period. While the gevokizumab-treated patients continued to show an improvement in all AUSCAN measures over their baseline scores after 168 days of therapy, the placebo treated patients showed a greater improvement over the final three months of the study, eliminating the separation seen between placebo and actively treated patients by the Day 168 time point. The company's primary analyses and other objective measures, such as MRIs and radiographs, did not suggest a significant drug-related benefit after six months. The company has begun analyses of relevant patient subgroups, and these data have shown placebo response was driven by patients with milder disease at baseline. Comparisons of patients with more severe pain (visual analog scale >= 75/100) at baseline show a consistent trend favoring gevokizumab in all components of their AUSCAN scores. In both proof-of-concept studies, gevokizumab demonstrated a statistically significant effect on CRP levels over the full study periods. It is possible these observations, as well as further analyses, could provide a reasonable group to study in future trials but it is too early to tell at this point. Gevokizumab was generally well tolerated, and there were no drug-related serious adverse events reported in these studies. The most common adverse events were headache, pain, arthralgia, urinary tract infections, upper respiratory tract infections and pneumonia, and they were comparable between gevokizumab and placebo.