XOMA Reports Third Quarter 2010 Financial Results
"The next several months will see pivotal events in the development of our flagship anti-inflammatory antibody candidate,
Enrollment completed in Phase 2a trial of
XOMA052 in patients with Type 2 diabetes: This randomized, placebo-controlled trial, in which 74 patients were enrolled, is designed to evaluate extended biologic activity and safety of XOMA052. Outcomes will include diabetes measures such as hemoglobin A1c, or HbA1c, and fasting blood glucose, or FBG, and C-reactive protein, or hsCRP, a biomarker of inflammation associated with cardiovascular risk. Interim results from the first three months of treatment in this six month trial are expected to be announced in the first half of January 2011.
Enrollment completed in Phase
2btrial of XOMA052 in patients with Type 2 diabetes: This randomized, placebo-controlled dose-ranging trial enrolled 420 patients and is designed to further evaluate the safety and efficacy of XOMA052 dosed once monthly compared to placebo. The results will include data on measurements of HbA1c, FBG and hsCRP. Top line results are expected to be announced in the first quarter of 2011.
XOMA052 designated orphan drug in U.S. and European Unionfor the treatment of Behcet's disease: Orphan drug designation generally provides multi-year marketing exclusivity and other potential advantages for the development of new agents to treat rare diseases. In June 2010, XOMAannounced positive results from an open-label pilot study of XOMA052 in seven patients with Behcet's disease who were suffering from vision-threatening disease exacerbations, known as uveitis, despite maximal doses of immunosuppressive medicines. XOMA052 was well-tolerated in this trial, and improvements in vision and ocular inflammation were observed in all seven patients following initial treatment, and in each of the five retreated patients.
$4 millionreceived from sale of rights to CIMZIA® royalties and $750,000milestone payment received from AVEO: The proceeds of the sale and milestone payment provide non-dilutive funding to support the development of XOMA052 and other programs.
$997,917in grants awarded under the Patient Protection and Affordable Care program: All four of the applications XOMAsubmitted under this program were awarded to the maximum allocation, providing non-dilutive capital to advance XOMA'sprograms to develop XOMA052, XOMA3AB, and monoclonal antibody therapeutics for the treatment of metabolic and oncologic diseases. The award payments were authorized on October 29, 2010.
Additional Financial Results
Interest expense for the third quarter of 2010 was
Liquidity and Capital Resources
Net cash used in operations during the first nine months of 2010 was
Reverse Stock Split and NASDAQ Compliance
Investor Conference Call
XOMA052, an anti-IL-1 beta antibody in Phase 2 clinical development for Type 2 diabetes with cardiovascular biomarkers, Type 1 diabetes, and with potential for the treatment of a wide range of inflammatory conditions. XOMA052 also has demonstrated positive clinical benefit in a proof-of-concept trial for the treatment of vision-threatening uveitis of Behcet's disease.
XOMA3AB, an antibody candidate in pre-IND studies to neutralize the botulinum toxin, among the most deadly potential bioterror threats, 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, inflammatory and oncologic diseases.
In addition to its proprietary pipeline,
The company has a premier antibody discovery and development platform that incorporates an unmatched collection of antibody phage display libraries and proprietary Human Engineering(tm), affinity maturation, Bacterial Cell Expression (BCE) and manufacturing technologies. BCE is a key breakthrough biotechnology for the discovery and manufacturing of antibodies and other proteins. As a result, sixty pharmaceutical and biotechnology companies have signed BCE licenses, and several licensed product candidates are in clinical development.
Safe Harbor Statement
Certain statements contained herein concerning timing of results of clinical trials or other aspects of product development, 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 timing of results of clinical trials may be delayed or may never become available as a result of complications in the collection or interpretation of statistical data, unavailability of resources, actions or inaction by our present or future collaboration partners, insufficient enrollment in such trials or unanticipated safety issues; and results of clinical trials may in any event not be consistent with preclinical or interim results.
These and other risks, including the generally unstable nature of current economic conditions; the results of discovery research and preclinical 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 —
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share amounts)|
Three months ended
Nine months ended
|License and collaborative fees||$ 1,410||$1,421||$ 1,749||$29,276|
|Contract and other revenue||5,733||3,688||18,025||18,662|
|Research and development||21,345||13,444||58,278||43,472|
|Selling, general and administrative||6,152||7,197||16,731||18,972|
|Total operating expenses||27,542||20,643||75,054||66,047|
|(Loss) income from operations||(16,645)||6,780||(51,013)||10,786|
|Other income (expense):|
|Investment and interest income||4||9||13||47|
|Loss on debt extinguishment||--||(3,645)||--||(3,645)|
|Other income (expense)||3,113||103||300||1,240|
|Net (loss) income before taxes||(13,632)||1,908||(50,981)||3,650|
|Provision for income tax expense (benefit)||1||370||17||6,083|
|Net loss||$(13,633)||$1,538||$(50,998)||$ (2,433)|
|Basic net (loss) income per common share||$ (0.69)||$ 0.14||$ (2.87)||$ (0.24)|
|Diluted net (loss) income per common share||$ (0.69)||$ 0.13||$ (2.87)||$ (0.24)|
|Shares used in computing basic net (loss) income per common share||19,802||11,150||17,742||10,211|
|Shares used in computing diluted net (loss) income per common share||19,802||11,517||17,742||10,211|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$ 16,860||$ 23,909|
|Trade and other receivables, net||7,944||7,231|
|Prepaid expenses and other current assets||1,486||1,012|
|Total current assets||26,290||32,152|
|Property and equipment, net||16,179||20,270|
|Total assets||$ 43,012||$ 52,824|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Accounts payable||$ 5,706||$ 2,942|
|Other current liabilities||--||223|
|Total current liabilities||17,761||18,678|
|Deferred revenue — long-term||1,346||2,894|
|Interest bearing obligation — long-term||13,505||13,341|
|Other long-term liabilities||353||385|
|Total liabilities and shareholders' equity||$ 43,012||$ 52,824|
XOMA Ltd.Company and Investor Contact: Carol DeGuzman510-204-7270 email@example.com Canale CommunicationsMedia Contact: Carolyn Hawley619-849-5375 firstname.lastname@example.org
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