XOMA Reports First Quarter 2011 Financial Results
"In the first quarter of 2011, we announced a strategic development and commercialization collaboration with Servier, a world-class pharmaceutical partner committed to advancing
Entered into strategic development and commercialization partnership for
XOMA052: The agreement with Servier includes an upfront payment and loan totaling approximately $35 million, potential milestone payments of approximately $470 million, depending on the U.S. dollar/euro exchange rate at the time the milestones are achieved, and tiered royalties up to a mid-teens percentage rate. Servier has committed to fund 100% of the first $50 millionof Behcet's uveitis development and 50% of further development in this indication, and to fund development of XOMA052 for cardiovascular disease and diabetes indications. This funding reduces the expenses XOMAmay incur to advance XOMA052. XOMAhas retained U.S. and Japanese development and commercialization rights to XOMA052 for Behcet's uveitis and other inflammatory and oncology indications. Servier has worldwide rights to the diabetes and cardiovascular disease indications and rights outside the U.S. and Japanto other indications. XOMAhas an option to reacquire rights to the diabetes and cardiovascular disease indications in the U.S. and Japan.
Phase 2 studies of
XOMA052 show positive anti-inflammatory results and confirmed safety: XOMAconducted two Phase 2 trials of XOMA052 in Type 2 diabetes patients, a 421 patient Phase 2b trial and a 74 patient Phase 2a trial. XOMA052 was well-tolerated in these trials, with no serious drug-related adverse events and a safety profile consistent with previous trials. The Phase 2b trial did not achieve the primary endpoint of reduction in glycosylated hemoglobin (HbA1c) levels after six monthly treatments with XOMA052 compared with placebo. A modest reduction in HbA1c levels was observed at a three month interim review of the Phase 2a trial.
The potential for cardiovascular benefit with
XOMA052 was observed in both trials, with highly significant (p≤0.0005) decreases in C-reactive protein (CRP), a biomarker for the risk of heart attack, stroke and other cardiovascular diseases, in all four Phase 2b dose groups versus placebo. A decrease in CRP also was observed in the Phase 2a trial, although the trial was designed primarily to evaluate safety and was not designed to demonstrate statistically significant differences in measures of biological activity. Also supporting the potential of XOMA052 in cardiovascular disease, significant (p≤0.05) improvements in high-density lipoprotein, or "good" cholesterol, were observed in two of four XOMA052 dose groups versus placebo in the Phase 2b trial.
XOMA3AB Phase 1 trial to be initiated by NIAID: The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, informed XOMAthat it is initiating 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.
XOMA3AB results reported at national biodefense meeting: Several presentations highlighted advances in the development of XOMA3AB. 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.
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XOMA052, a potentially best-in-class antibody that binds to the inflammatory cytokine interleukin-1 beta, or IL-1 beta. XOMAplans to enter XOMA052 into Phase 3 clinical development in Behcet's uveitis, an orphan indication. XOMA052 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 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
** Tables Follow **
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share amounts)|
Three months ended
|License and collaborative fees||$ 5,827||$ 189|
|Contract and other revenue||9,661||6,811|
|Research and development||17,347||17,587|
|Selling, general and administrative||5,369||5,553|
|Total operating expenses||22,716||23,140|
|Loss from operations||(7,121)||(15,938)|
|Other income (expense):|
|Investment and interest income||10||3|
|Other income (expense)||1,323||(5,763)|
|Net loss before taxes||(6,320)||(21,785)|
|Provision for income tax expense||(15)||--|
|Net loss||$ (6,335)||$ (21,785)|
|Basic and diluted net loss per common share||$ (0.22)||$ (1.36)|
|Shares used in computing basic and diluted net loss per common share||29,180||15,966|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$ 56,874||$ 37,304|
|Trade and other receivables, net||10,233||20,864|
|Prepaid expenses and other current assets||465||712|
|Total current assets||67,572||58,880|
|Property and equipment, net||14,401||14,869|
|Total assets||$ 82,476||$ 74,252|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Accounts payable||$ 3,746||$ 3,581|
|Total current liabilities||22,333||35,528|
|Deferred revenue — long-term||9,427||1,086|
|Interest bearing obligations — long-term||26,241||13,694|
|Other long-term liabilities||272||353|
|Total liabilities and shareholders' equity||$ 82,476||$ 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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