XOMA Reports Second Quarter 2011 Financial Results
"Our financial results for the second quarter of 2011 as compared with the same period last year reflect the favorable impact of funding received from our
XOMA3AB Phase 1 trial initiated by NIAID: The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, initiated a Phase 1 trial of XOMA3AB, a novel formulation of three antibodies designed to prevent and treat botulism poisoning, among the most deadly bioterror threats. This double-blind, dose-escalation study in approximately 24 healthy volunteers, is designed to assess the safety and tolerability and determine the pharmacokinetic profile of XOMA3AB. More information is available at http://www.clinicaltrials.gov/ct2/show/NCT01357213?term=XOMA+3AB&rank=1
Discovery of two new classes of insulin receptor-regulating antibodies reported at
American Diabetes Association71st Scientific Sessions: Insulin is the key metabolic hormone for regulating blood sugar and exerts its action on cells by signaling through the insulin receptor. Insulin receptor-activating antibodies such as XOMA'sXMetA antibody are designed to provide long-acting insulin-like activity to diabetic patients who cannot make sufficient insulin, potentially reducing the number of insulin injections needed to control their blood glucose levels. In contrast, insulin receptor-sensitizing antibodies such as XOMA'sXMetS are designed to reduce insulin resistance and could enable diabeties patients to more effectively use their own insulin to control blood glucose levels.
New U.S. patent issued covering
XOMA052 use in certain interleukin-1 beta-related coronary conditions: On August 2, the U.S. Patent and Trademark Office issued XOMAa new patent covering methods of treating certain coronary conditions including myocardial infarction, or heart attack, using XOMA052 and interleukin-1 beta antibodies with similar binding properties. This is the tenth U.S. patent from the XOMA052 program to have been issued, in addition to numerous pending applications and granted patents outside of the United States.
Six month top line results from 74 patient
XOMA052 Phase 2a trial support safety and biological activity: XOMA052 was well tolerated with no significant differences between the XOMA052 and placebo groups in observations of adverse events. XOMA052 continued to show evidence of biological activity as shown by a reduction in levels of C-reactive protein, a biomarker of cardiovascular risk. There were no differences in glycemic control between the drug groups and placebo as measured by hemoglobin A1c levels. This Phase 2a trial was designed as an exploratory trial focused on overall safety and kinetics and was not designed to show statistically significant differences in measures of biological activity. The results were as expected based on data from the Phase 2a three-month interim review and the 421 patient Phase 2b trial.
Investor Conference Call and Webcast
XOMA052, a potentially best-in-class antibody that binds to the inflammatory cytokine interleukin-1 beta, or IL-1 beta. Les Laboratoires Servieris XOMA'sdevelopment and commercialization partner for XOMA052. XOMAand Servierplan to enter XOMA052 into Phase 3 clinical development for Behcet's uveitis, an orphan indication, and Phase 2 development for cardiovascular disease.
XOMA3AB, a novel combination of three antibodies in one product under development to prevent and treat botulism poisoning caused by exposure to botulinum neurotoxin Type A, among the most deadly bioterror threats. XOMA 3AB is in a Phase 1 clinical trial sponsored by the National Institute of Allergyand Infectious Diseases (NIAID) of the National Institutesof Health (NIH). XOMAreceives funding for development of XOMA3AB under NIAID Contract # HHSN266200600008C.
- A preclinical pipeline with candidates in development for autoimmune, cardio-metabolic, inflammatory and oncologic diseases.
Certain statements contained herein concerning anticipated levels of cash utilization, initiation of clinical trials, or interim or other results of early-stage clinical trials, or that otherwise relate to future periods are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on assumptions that may not prove accurate. Actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market.
Among other things, the anticipated levels of cash utilization may be other than as expected due to unanticipated changes in
These and other risks, including those related to the generally unstable nature of current economic and financial market conditions; the results of discovery and pre-clinical testing; the timing or results of pending and future clinical trials (including the design and progress of clinical trials; safety and efficacy of the products being tested; action, inaction or delay by the
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share amounts)|
Three months ended
Six months ended
|License and collaborative fees||$ 6,039||$ 150||$ 11,866||$ 339|
|Contract and other revenue||10,467||5,481||20,128||12,292|
|Research and development||18,281||19,346||35,628||36,933|
|Selling, general and administrative||6,113||5,026||11,483||10,579|
|Total operating expenses||24,394||24,372||47,111||47,512|
|Loss from operations||(7,869)||(18,430)||(14,991)||(34,368)|
|Other income (expense):|
|Investment and interest income||18||6||28||9|
|Other income (expense)||355||2,950||1,678||(2,813)|
|Net loss before taxes||(8,130)||(15,564)||(14,451)||(37,349)|
|Provision for income tax expense||--||(16)||(15)||(16)|
|Net loss||$ (8,130)||$ (15,580)||$ (14,466)||$ (37,365)|
|Basic and diluted net loss per common share||$ (0.27)||$ (0.93)||$ (0.49)||$ (2.24)|
|Shares used in computing basic and diluted net loss per common share||29,889||16,695||29,536||16,695|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$ 51,157||$ 37,304|
|Trade and other receivables, net||11,059||20,864|
|Prepaid expenses and other current assets||807||712|
|Total current assets||63,023||58,880|
|Property and equipment, net||14,410||14,869|
|Total assets||$ 79,598||$ 74,252|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Accounts payable||$ 5,043||$ 3,581|
|Total current liabilities||19,507||35,528|
|Deferred revenue — long-term||8,665||1,086|
|Interest bearing obligations — long-term||27,031||13,694|
|Other long-term liabilities||257||353|
|Total liabilities and shareholders' equity||$ 79,598||$ 74,252|
XOMA Ltd.Company and Investor Contact: Carol DeGuzman510-204-7270 firstname.lastname@example.org Canale CommunicationsMedia Contact: Carolyn Hawley619-849-5375 email@example.com
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