XOMA Reports 2010 and Fourth Quarter Financial Results
"In 2010, we successfully secured a global joint development partnership with Servier for multiple indications of our lead product candidate,
"Looking forward to a busy and exciting year, later this month we expect to report top line results from the full six months' treatment with
For the fourth quarter ended
Entered into global
XOMA052 development and commercialization partnership: This agreement with Servier, a leading independent pharmaceutical company established in 140 countries with EUR3.7 billionin 2010 sales, includes the following:
XOMAvaluable commercial rights and options in the U.S. and Japanfor multiple indications including Behcet's uveitis and other inflammatory and oncology indications,
Enables acceleration of
XOMA052 into Phase 3 development in 2011 in Behcet's uveitis, an orphan indication,
- Advances the company's strategy of focusing on near-term opportunities to develop and commercialize products in the U.S., and
XOMA'scash resources and provides additional XOMA052 licensing opportunities for XOMAin the U.S. and Japanfor diabetes and cardiovascular disease.
Under the collaboration agreement, Servier will provide an initial
Completed enrollment in two Phase 2 trials of
XOMA052 in patients with Type 2 diabetes: To date, more than 600 patients have been enrolled in clinical trials of XOMA052, including 74 patients in the Phase 2a trial and 420 patients in the multicenter, randomized, placebo-controlled Phase 2bdose-ranging trial. Later this month, XOMAplans to report top line results from the Phase 2btrial, including hemoglobin A1c levels and C-reactive protein, following six months' treatment with XOMA052 at one of four dose levels or placebo. Hemoglobin A1c is a measure indirectly reflecting blood glucose levels as averaged over a 90 to 120 day period and C-reactive protein is a biomarker of cardiovascular risk.
Announced an interim review of three-month data from Phase 2a clinical trial of
XOMA052: This trial was designed to evaluate the overall safety and kinetics and was not designed to show statistically significant differences in measures of biological activity. A total of 74 patients with Type 2 diabetes, including 55 treated with XOMA052 at a single dose level and 19 on placebo, were treated. At the three month interim review, XOMA052 was shown to be well-tolerated with no drug-related serious adverse events and demonstrated evidence of biological activity, including a reduction in C-reactive protein levels and a modest reduction in hemoglobin A1c levels. In the final three months of the trial, patients in the XOMA052 group receive the same, higher or lower dose level, and patients in the placebo group will continue to receive placebo. XOMAanticipates reporting the results from the full six months' treatment in this trial during the second quarter of 2011.
Received two new patents covering
XOMA052: The patents cover methods of treatment for Type 1 diabetes and certain cancers, including multiple myeloma, using XOMA052 or other IL-1 beta antibodies with similar binding characteristics to XOMA052. XOMAnow has eight issued U.S. and European patents for the XOMA052 program, demonstrating success in building a strong intellectual property portfolio to protect innovation around XOMA052.
$1 millionin grants under Patient Protection and Affordable Care Program: All four of XOMA'sgrant applications were awarded the maximum allocation, providing funding for ongoing XOMAprograms that address unmet medical needs in the areas of inflammation including diabetes and cardiovascular disease, biodefense, metabolic diseases and cancer.
XOMA3AB results at national biodefense meeting: Several presentations highlighted advances in the development of XOMA3AB, a novel combination of three antibodies in one product that bind to distinct regions of botulinum toxin type A, one of the most deadly bioterror threats. These included an invited oral presentation describing the successful lyophilization of XOMA3AB, and studies demonstrating the stability of this formulation over time stored at a wide range of temperatures. The presentations were made at the Fifth Annual Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Stakeholders Workshopin Washington, DC.
Investor Conference Call and Webcast
To date, nearly 600 patients have been enrolled in
About Behcet's Disease and Behcet's Uveitis
Behcet's (pronounced beh-CHETS) disease causes chronic inflammation of the blood vessels, or vasculitis, among other complications. Uveitis is a vasculitis of the blood vessels in the eye which can be vision-threatening. Behcet's uveitis is one of the most severe forms of uveitis which can lead to blindness and affects approximately 50% of Behcet's disease patients.
Without immediate treatment, major exacerbations of Behcet's uveitis may lead to retinal detachment, macular edema, vitreous hemorrhage, glaucoma and eventual blindness. The effects of these exacerbations on vision are cumulative. Patients often experience multiple exacerbations per year, requiring treatment to control the frequency and severity of attacks of this chronic disease. No therapies are approved in the U.S. to treat Behcet's disease. It is treated with corticosteroids and immunosuppressive drugs, which can have significant side effects, including diabetes and hypertension, and can contribute to other eye diseases like glaucoma and the formation of cataracts. These drugs also can adversely affect the neurological, pulmonary, gastrointestinal, hematological and cardiovascular systems.
XOMA052, a potentially best-in-class antibody that binds to the inflammatory cytokine interleukin-1 beta, or IL-1 beta. XOMA052 is entering Phase 3 clinical development in Behcet's uveitis, an orphan indication, and is in Phase 2 clinical development for diabetes with cardiovascular disease biomarkers. Les Laboratoires Servier is XOMA'sdevelopment and commercialization partner for XOMA052.
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. XOMA3AB is under development through funding provided by the National Institute of Allergyand Infectious Diseases of the National Institutesof Health (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, timing of initiation or availability of results of clinical trials, interim or other results of early-stage clinical trials or additional licensing opportunities, 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 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
** Tables Follow **
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share amounts)|
Three months ended
|License and collaborative fees||$ 433||$ 14,546||$ 2,182||$ 43,822|
|Contract and other revenue||9,150||6,830||27,174||25,492|
|Research and development||19,134||14,659||77,413||58,131|
|Selling, general and administrative||6,520||4,764||23,250||23,736|
|Total operating expenses||25,691||19,423||100,745||85,470|
|(Loss) income from operations||(16,090)||2,174||(67,104)||12,960|
|Other income (expense):|
|Investment and interest income||2||2||16||49|
|Loss on debt extinguishment||--||--||--||(3,645)|
|Other (expense) income||(1,556)||561||(1,256)||1,801|
|Net (loss) income before taxes||(17,748)||2,627||(68,729)||6,277|
|Provision for income tax (expense) benefit||(10)||356||(27)||(5,727)|
|Net (loss) income||$ (17,758)||$ 2,983||$ (68,756)||$ 550|
|Basic and diluted net (loss) income per common share||$ (0.84)||$ 0.22||$ (3.69)||$ 0.05|
|Shares used in computing basic net (loss) income per common share||21,195||13,313||18,613||10,993|
|Shares used in computing diluted net (loss) income per common share||21,195||13,645||18,613||11,313|
|CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$ 37,304||$ 23,909|
|Trade and other receivables, net||20,864||7,231|
|Prepaid expenses and other current assets||712||1,012|
|Total current assets||58,880||32,152|
|Property and equipment, net||14,869||20,270|
|Total assets||$ 74,252||$ 52,824|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Accounts payable||$ 3,581||$ 2,942|
|Other current liabilities||8||223|
|Total current liabilities||35,528||18,678|
|Deferred revenue — long-term||1,086||2,894|
|Interest bearing obligations — long-term||13,694||13,341|
|Other long-term liabilities||353||385|
|Total liabilities and shareholders' equity||$ 74,252||$ 52,824|
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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