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Here comes the sell off!
Confirmed by?
And it is reacting to the news, holy cow!
I thought it was suppose to be the day before the day after tomorrow.
Where's the "NEWS"?
No. the dividend comes first!
Lot's of profit taking this AM, hopefully it won't kill any momentum.
Pre-market trading is definitely showing a move towards a fun day!
This pup is definitely getting hammered today!
I'm with you on that statement Mikey.
And the news will be coming when?
Heck, TDAmeritrade doesn't show any trades either.
They've become WallStreet Bankers, if the doors are still open everybody gets LA*D!
And it looks like they are!
China Security & Surveillance Technology, Inc. Reports Fourth-Quarter and Full-Year 2009 Results
7:59a ET March 2, 2010 (PR NewsWire)
Note: CSST's fourth-quarter and full-year 2009 earnings conference call will be broadcast live via the Internet at 8 a.m. ET on Tuesday, March 2, 2010, at http://irpage.net/csct/index.html .
China Security & Surveillance Technology, Inc. ("CSST" or the "Company") (NYSE: CSR; Nasdaq Dubai: CSR), a leading provider of digital surveillance technology in the P.R.C., today reported fourth-quarter and full-year 2009 results highlighted by encouraging earnings growth, full-year solid and positive cash flow, and robust growth in revenues from government sector in China. Full-year 2009 EPS grew 40.3%, driven by the growing demand for CSST's products and services, success of convertible notes restructuring, as well as solid execution of cost control initiatives.
Full-year 2009 revenues totaled $580.87 million; and net cash from operating activities totaled $52.60 million, versus $39.10 million net cash used in operating activities in 2008.
"Despite the economic environment, we had a solid 2009 and led the industry in many areas," said Mr. Guoshen Tu, Chairman and Chief Executive Officer of CSST. "Our system installation business in the government sector, particularly safe city and e-city projects, continues to ramp, improving our government revenue profile. We landed several major e-city projects in China, and we continued to see robust growth in the corporate sector."
"During the past year, we took major steps to improve CSST's financial position for 2010 and beyond. The success of our convertible notes restructuring has improved our capital structure and strengthened our balance sheet. We also delivered our cost initiatives which yielded positive results for our earnings," said Mr. Tu.
Fourth-Quarter Financial Results
To simplify its presentation, and in recognition of the completed restructuring of convertible notes, starting third quarter 2009, CSST no longer presents Non-GAAP results and instead presents reported results accompanied by details on key factors impacting results.
For the quarter ended December 31, 2009, CSST's revenues totaled $182.71 million, compared with $143.55 million in the year-earlier quarter and up 14.3% from the third quarter of 2009. This marked CSST's third consecutive quarter with double-digital revenue growth.
Gross profit totaled $51.48 million, up 43.8% from $35.81 million in the year-earlier period. Gross margin increased to 28.2% from 24.9% for the same period in 2008. Sequentially, gross margin increased 610 basis points as a result of expanded profitability of the installation segment. Correspondingly, income from operations increased to $28.20 million, up 68.4% from the year-earlier quarter. Operating margin increased to 15.4%, compared with 11.7% in the year-earlier quarter and 10.8% in the third quarter of 2009.
Net income attributable to CSST totaled $26.06 million, up 132.3% compared with $11.22 million in the year-earlier quarter, and diluted earnings per share totaled $0.38, compared with $0.23 in the year-earlier quarter.
Full-Year Financial Results
For the full year 2009, CSST's revenues totaled $580.87 million, up 35.9% versus $427.35 million in 2008. The growth reflected the strong demand for CSST's products and services, CSST's established brand awareness and extensive distribution network. Government customers accounted for 52% of total revenues, while corporate customers accounted for 48%. Organic revenues for 2009 totaled $543.89 million, or 93.6% of total revenues, compared to $361.5 million or 84.6% in 2008. Non-organic revenues totaled $36.98 million or 6.4% of total revenues.
Gross profit totaled $142.87 million, up 18.5% from $120.54 million in 2008. Gross margin was 24.6%, down 360 basis points from 28.2% last year. The slight drop was due to the decrease of selling prices and relatively lower margin for smaller-scale projects. It was also a result of CSST's efforts to maintain market share and expand customer base in China.
Operating income increased 14.8% to $65.96 million while operating margin decreased to 11.3%, as a result of lower gross margin.
Net income attributable to CSST totaled $56.58 million, up 73.6% from $32.60 million in 2008; and diluted earnings per share totaled $1.01 versus $0.72 in 2008.
CSST recognized a total of non-cash items at $36.36 million, down from $42.97 million in 2008. There were three components for the non-cash expenses, which were $12.74 million, or $0.23 per diluted share related to depreciation and amortization; $18.09 million, or $0.32 per diluted share related to non-cash employee compensation; and $14.85 million, or $0.26 per diluted share from redemption accretion on convertible notes prior to the restructuring. CSST also recorded a one-time non-cash gain on modification of convertible notes of $9.32 million, or $0.17 per diluted share. Weighted average diluted share count increased to 56.17 million compared with 45.28 million in 2008.
CSST's full-year net cash from operating activities totaled $52.60 million, versus $39.10 million net cash used in operating activities for 2008. As of December 31, 2009, CSST's cash balance was $154.48 million, compared with $100.98 million at the end of the third quarter.
Financial Outlook
For the full year 2010, CSST reaffirms its revenue projection of $800 to $820 million and diluted earnings per share of $1.15 to $1.20.
"Looking ahead, mainland demand for our products and services continues to be strong, and we are well positioned at the center of this growth," said Mr. Tu. "The announced acquisitions in 2009 will continue to provide us with a growth platform to expand our industry-leading capabilities in security and surveillance offerings. Our market leadership in China continues to set us apart as we roll out more products and services this year and expand security service capabilities in the years ahead."
"We will further accelerate our efforts to secure sizeable government contracts and capitalize on the growing opportunities in safe city and e-city projects. We will continue cost-improvement initiatives to maintain a healthy margin for our business. Our fundamental outlook for the business is positive," concluded Mr. Tu.
And that would be???
Just where would one find the FAQ section?
That person sounds a touch angry.
It means they just told us to bend over!
It's been a tough couple of weeks for the market, but at least PYCT has held and not dropped below it's 1 year bid price!
Based on..... ?
Live outside KC, worse snow fall in 20+ years. Snowed for three days! Bah Humbug!
But it's always nice when brokerage firms change their position....
XOMA Started At Buy By Canaccord >XOMALast update: 11/18/2009 6:57:48 AM
Mikey, what do you know? LOL
XOMA Reports 2009 Third Quarter Financial Results
8:00a ET November 9, 2009 (GlobeNewswire)
XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced its financial results for the third quarter and nine months ended September 30, 2009 and provided a general business update. XOMA has made significant progress in 2009 toward its objective of becoming a company focused on proprietary product development and has done so while generating revenues from its technology licensing collaborations, royalties and biodefense businesses in difficult circumstances that included the removal of royalty generating RAPTIVA(R) from the market and a particularly challenging economic environment. The following are XOMA's key accomplishments in 2009.
* Proprietary pipeline: The company has advanced XOMA 052,
its anti-inflammatory antibody to interleukin-1 beta (IL-1
beta), through the completion of successful Phase 1 trials
and into Phase 2 development in Type 2 diabetes and
cardiometabolic diseases. XOMA reported new preclinical
results showing the benefit of XOMA 052 in reducing the
buildup of plaque which can lead to hardening of the
arteries and heart attack. Preclinical results with another
IL-1 targeting agent have shown beneficial effects in
cardiac remodeling which may reduce the risk of congestive
heart failure following heart attack. These results provide
direct evidence of the potential for IL-1 inhibition to
beneficially impact major cardiovascular diseases. Based on
these developments and its Phase 1 results, XOMA has expanded
its XOMA 052 development strategy to cardiovascular diseases.
XOMA has also advanced its XOMA 3AB anti-botulism antibody
for biodefense into pre-IND studies and continues to develop
its proprietary preclinical pipeline in inflammatory,
cardiometabolic, infectious and oncologic diseases.
* Antibody collaboration revenues: Collaboration, licensing
and biodefense revenues totaled $48 million in the first
nine months of 2009. With the signing of new agreements with
Kaketsuken and the Cephalon subsidiary Arana Therapeutics,
actual and anticipated non-royalty revenues now total $62
million for the year thus far.
* Marketed product royalties: Royalties for LUCENTIS(R),
CIMZIA(R) and RAPTIVA(R), including a one-time prepayment of
$25 million for future LUCENTIS royalties, generated revenues
of $28.9 million through September 30, 2009.
* Total revenues: For the nine months ended September 30, 2009,
XOMA recorded revenues of $76.8 million, compared with $31.1
million for the same period of 2008.
Total revenues in the 2009 third quarter were $27.4 million, compared to $7.9 million in the 2008 third quarter. The company had net income $1.5 million or $0.01 per share in the 2009 third quarter, compared with a net loss of $20.4 million, or $0.15 per share, for the third quarter of 2008. The improvement was primarily due to increased revenues as a result of the sale of the LUCENTIS(r) royalty interest and decreased operating expenses.
Total operating expenses were $20.6 million in the 2009 third quarter, compared with $26.4 million for the third quarter of 2008. This decrease was primarily due to reduced expenses arising from the workforce reduction in January 2009, particularly in manufacturing and related areas and associated selling, general and administrative support, as well as multiple cost control initiatives.
At September 30, 2009, XOMA had unrestricted cash, cash equivalents and short-term investments of $27.7 million, compared with $10.8 million at December 31, 2008. In September 2009, the company fully repaid principal and accrued interest totaling $44.4 million on its loan with Goldman Sachs Specialty Lending Holdings, Inc. (Goldman Sachs).
"We are excited about the new cardiovascular results from preclinical and clinical studies with XOMA 052 and other IL-1 targeting agents and our expanded strategy for XOMA 052 in cardiovascular diseases. This adds substantial value to XOMA 052. We are also pleased to have exceeded expectations for generating revenues during the first three quarters of this year," said Steven B. Engle, XOMA's Chairman and Chief Executive Officer. "Based on our cash reserves, anticipated revenues from collaborations including a XOMA 052 corporate partnership, licensing transactions and biodefense contracts, we believe XOMA has sufficient cash resources to meet its anticipated net cash needs into 2011.
"We continue to make progress in our discussions with potential partners," Mr. Engle continued. "Importantly, new cardiovascular results combined with previous data greatly increase the value of XOMA 052. As a result, partners need additional time to review the new data. As might be expected, with our financial flexibility and depending on ongoing discussions, we may complete a partnership in the original time frame, or it may take some additional time for partners to fully value XOMA 052's potential beyond diabetes."
Recent Highlights
* XOMA 052 Phase 2 clinical development program initiated in
Type 2 diabetes and cardiometabolic diseases: Based on
positive results in two Phase 1 studies conducted in 98
patients, XOMA initiated its Phase 2a program with an
extended safety and biological activity study in Type 2
diabetes patients for which interim results may be available
by the third quarter of 2010. XOMA also plans to conduct a
Phase 2a cardiometabolic study intended to provide more
details about beta cell and endothelial functions. XOMA
anticipates initiating this trial in the first quarter of
2010. These and other studies will more fully characterize
the multiple biological activities of XOMA 052, collect
additional safety data and provide results supporting design
of pivotal Phase 3 trials.
* XOMA 052 demonstrates statistically significant reduction
in the formation of plaque in preclinical studies:
Preclinical results with XOMA 052 in an animal model of
cardiovascular disease were presented in October at the 2009
Annual Meeting of the Society for Leukocyte Biology,
International Cytokine Society, & International Society for
Interferon and Cytokine Research (Tri-Society). The
presentation included results of studies in the apolipoprotein
E (ApoE) "knockout" mouse model, a well-validated model of
atherosclerosis that follows a similar pattern of progression
to that in humans. The studies demonstrated that mice treated
with a murine equivalent of XOMA 052 had a statistically
significant reduction in the formation of plaque in the aorta,
and trends toward improved lipid profiles, compared to mice
receiving a control antibody. These results demonstrate for
the first time that XOMA 052 has a direct, beneficial effect
on plaque build-up in an animal model of cardiovascular
disease.
* XOMA expands XOMA 052 development strategy into cardiovascular
disease indications: New findings on the reduction of
cholesterol, plaque damage to the heart after heart attack,
biomarker results from the XOMA 052 Phase 1 trials and other
studies of IL-1 targeting agents indicate that XOMA 052 is
likely to have positive benefits in cardiovascular disease.
The combination of these findings has led XOMA to expand the
cardiovascular disease development strategy for XOMA 052 and
greatly increases the potential value of XOMA 052.
* Results presented at international diabetes meeting
demonstrate XOMA 052's unique regulatory mechanism of action
in regulating IL-1 beta signaling: At the European Association
for the Study of Diabetes annual meeting in September, XOMA
reported results demonstrating that XOMA 052 regulates IL-1
beta signaling, reducing pathologically high levels that
cause disease while allowing normal and beneficial low levels.
This regulatory mechanism of action for XOMA 052 differs from
some antibodies to IL-1 which are designed to completely block
all contact between target and receptor, and if shown in
clinical studies, may confer safety advantages in chronic
diseases including diabetes and cardiovascular diseases.
* New indication for XOMA 052 in Type 1 diabetes to be
evaluated in Phase 2 clinical trial funded by Juvenile
Diabetes Research Foundation: The study is designed to
measure the effects of treatment with XOMA 052 over six
months on beta cell function and insulin production in 24
patients with well-controlled Type 1 diabetes who have had
the disease for at least two years. It will test the novel
hypothesis that inhibiting the activity of IL-1 beta may
prevent ongoing beta cell death at later stages of disease,
when most beta cells have been destroyed, and allow beta cell
regeneration to prevail and repopulate the pancreas. It is
complementary to ongoing trials with IL-1 and immune
modulating agents at earlier disease stages. The Juvenile
Diabetes Research Foundation International is the largest
Type 1 diabetes patient advocacy organization in the world.
* New antibody technology collaborations provide $14 million:
XOMA signed agreements with Cephalon's subsidiary, Arana
Therapeutics, and Kaketsuken, a private research institute
based in Japan, covering multiple proprietary XOMA antibody
research and development technologies, including XOMA's new
antibody phage display libraries, and suites of integrated
information and data management systems. These are the second
and third technology collaborations XOMA has initiated this
year, the three of which together are expected to generate
fee revenue totaling $43 million and potential future
milestone and royalty payments.
* New contracts for federal government biodefense and public
health programs to provide $3.9 million: XOMA was awarded
two new subcontracts from the National Institutes of Allergy
and Infectious Disease of the National Institutes of Health
to develop and optimize novel antibody drugs against
important biodefense and public health threats. One contract,
for $2.2 million, is for the development of a novel antibody
that has been shown by Dana-Farber Cancer Institute and
Harvard Medical School researchers to neutralize group 1
influenza A viruses, including the H1N1 and the H5N1 strains.
The other contract provides $1.7 million for the development
of an antibody to the virus that causes SARS, a highly
contagious infectious disease that often leads to pneumonia
and may be fatal.
* First European patent granted covering XOMA 052: The patent,
granted by the European Patent Office, provides protection
through 2026 for XOMA 052 as well as nucleic acids, expression
vectors and production cell lines for the manufacture of
XOMA 052.
Additional Financial Results
XOMA's total revenues in the third quarter of 2009 included $22.3 million in royalty income, $3.7 million in contract and other revenue, and $1.4 million in license and collaborative fees. In the 2008 third quarter, revenues included $4.6 million in royalties, $2.0 million in contract and other revenue, and $1.3 million in license and collaborative fees. The increase in royalty revenue was primarily due to the sale to Genentech of XOMA's royalty interest in LUCENTIS(R).
XOMA receives royalties based on U.S. sales of CIMZIA(R), which is marketed by UCB SA for the treatment of moderate to severe rheumatoid arthritis, an estimated $10 billion overall market, and Crohn's disease. Royalties on sales of CIMZIA(R) in the third quarter of 2009 were $0.2 million, and are expected to increase as UCB continues the CIMZIA(R) launch in the U.S. rheumatoid arthritis market.
XOMA's research and development expense for the third quarter of 2009 was $13.4 million, compared with $19.7 million in the same period of 2008. This decrease was due to decreased personnel costs as a result of the January 2009 workforce reduction, and reduced spending resulting from multiple additional cost control initiatives. Selling, general and administrative expenses for the third quarter of 2009 were $7.2 million compared with $6.7 million for the same period last year.
Interest expense for the third quarter of 2009 was $1.3 million compared with $2.0 million for the same period of 2008. This decrease is primarily due to the repayment in full of the Goldman Sachs loan in September 2009 and a decrease in the outstanding principal balance of and interest rate on the Novartis note.
Loss on debt extinguishment for the third quarter of 2009 was $3.6 million related to the repayment of our Goldman Sachs loan. This loss includes a prepayment premium of $2.5 million and the recognition of unamortized debt issuance costs of $1.1 million.
Debt Obligations
In September 2009, XOMA fully repaid its term loan facility with Goldman Sachs, including the outstanding principal balance of $42.0 million and accrued interest of $2.4 million.
With this repayment, XOMA's sole debt obligation at the end of the third quarter is a $13.1 million long-term note due to Novartis. This note was established under a loan facility to facilitate XOMA's participation in its collaboration with Novartis including the development of HCD 122 which is in Phase 1a/2 clinical testing for lymphoma. The Novartis loan is secured by XOMA's interest in the collaboration and is due in 2015.
Liquidity and Capital Resources
Cash, cash equivalents and short-term investments at September 30, 2009 was $27.7 million compared with $10.8 million at December 31, 2008. In September 2009, in addition to the repayment of the Goldman Sachs loan, the company completed two common share financings under its committed equity line of credit facility with Azimuth Opportunity Ltd. that provided approximately $26.4 million in gross proceeds to the company. Approximately $12.3 million of these proceeds were used, together with other funds, to repay the Goldman Sachs loan.
Cash provided by operating activities during the first nine months of 2009 was $11.5 million compared with cash used in operating activities of $35.8 million during the first nine months of 2008. This change is primarily due to license and collaborative fees and the sale of the LUCENTIS(r) royalty interest to Genentech.
In the third quarter of 2009, XOMA entered into an At Market Issuance Sales Agreement with Wm Smith & Co. under which XOMA may issue up to 25 million of its common shares from time to time through Wm Smith as agent by means of one or more "at the market" offerings or, with XOMA's approval, in negotiated transactions. The company's equity line of credit facility with Azimuth is no longer in effect and no additional shares can be issued under it.
A more detailed tabulation of XOMA's financial results appears below, and a more complete discussion is included in the company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2009.
Guidance
The company will not be providing guidance on revenues or cash receipts for 2009 so as to best manage its ongoing negotiations for XOMA 052 and technology licensing and in light of general economic and market conditions.
The company expects that cash used in operating activities for 2009 may range from $5 million to cash neutral or positive. This guidance is updated from its prior estimate that cash used in operating activities for 2009 may range from $15 million to cash neutral.
Investor Conference Call
XOMA will host a conference call and webcast to discuss its third quarter 2009 financial results today, November 9, 2009, at 9:00 a.m. ET. The webcast can be accessed via the Investors section of XOMA's website at http://investors.xoma.com/events.cfm and will be available for replay until close of business on January 8, 2010. Telephone numbers for the live audiocast are 888-677-8749 (U.S./Canada) and 913-312-1468 (international). A telephonic replay will be available beginning approximately two hours after the conclusion of the call until close of business on November 18, 2009. Telephone numbers for the replay are 888-203-1112 (U.S./Canada) and 719-457-0820 (international), passcode 1808574.
About XOMA
XOMA discovers, develops and manufactures novel antibody therapeutics for its own proprietary pipeline as well as through license and collaborative agreements with pharmaceutical and biotechnology companies, and under its contracts with the U.S. government. The company's proprietary product pipeline includes:
* XOMA 052, an anti-IL-1 beta antibody in Phase 2 development for
Type 2 diabetes, Type 1 diabetes and cardiovascular disease, with
potential for the treatment of a wide range of inflammatory diseases
* XOMA 3AB, 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 Institutes of Allergy and Infectious Diseases of the
National Institutes of Health
* A preclinical pipeline with candidates in development for
inflammatory, inflammatory, cardiometabolic, infectious and
oncologic diseases.
In addition to its proprietary pipeline, XOMA develops products with premier pharmaceutical companies including Novartis AG, Schering-Plough Research Institute and Takeda Pharmaceutical Company Limited. XOMA has multiple revenue streams resulting from the licensing of its antibody technologies, product royalties, development collaborations and biodefense contracts. XOMA's technologies have contributed to the success of marketed antibody products, including LUCENTIS(R) (ranibizumab injection) for wet age-related macular degeneration and CIMZIA(R) (certolizumab pegol) for rheumatoid arthritis and Crohn's disease.
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, more than 50 pharmaceutical and biotechnology companies have signed BCE licenses, and several licensed product candidates are in clinical development.
XOMA has a fully integrated product development infrastructure, extending from pre-clinical science to approval, and a team of about 200 employees at its Berkeley, California location. For more information, please visit http://www.xoma.com.
XOMA Expands Development Strategy for XOMA 052 to Include Cardiovascular Diseases
8:00a ET November 6, 2009 (GlobeNewswire)
XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced the expansion of its development strategy for its XOMA 052 antibody to interleukin-1 beta (IL-1 beta) to include effects on cholesterol lowering, reducing plaque deposits and damage to heart muscle and resulting long-term effects that can lead to heart attack, stroke and congestive heart failure. The strategy is supported by results from XOMA 052 Phase 1 trials demonstrating improvement in biomarkers associated with cardiovascular risk, ongoing clinical trials in cardiovascular disease with other IL-1 targeted agents, animal studies with XOMA 052 that have demonstrated significant reductions in plaque formation and improvements in lipid levels, and positive results with another IL-1 targeted agent in an animal model of cardiac remodeling after heart attack. XOMA's current XOMA 052 program is focused on Type 2 diabetes and this expansion represents an enormous increase in the number of patients who could be helped by this general anti-inflammatory approach.
In XOMA's Phase 1 XOMA 052 trials, patients with Type 2 diabetes had improvements in high-sensitivity C-reactive protein (hsCRP) and erythrocyte sedimentation rate (ESR), biomarkers of systemic inflammation associated with cardiovascular risk as well improvement in diabetic parameters(1). Two ongoing clinical trials of anakinra, another agent targeting IL-1, in acute coronary syndromes provide further support for a new anti-inflammatory approach to cardiovascular disease(2,3). Recently reported preclinical animal results have demonstrated that XOMA 052 treatment resulted in reduction in the formation of atherosclerotic plaque(4). Other recent preclinical animal results with XOMA 052 have shown reductions in total cholesterol without reduction in high density lipoprotein, and reduction in triglycerides and free fatty acids(5). Recently published results demonstrated that treatment with anakinra in a mouse model of heart attack resulted in amelioration of the adverse cardiac remodeling, and a statistically significant improvement in survival compared to control animals(6).
"XOMA 052 results demonstrating improved cardiovascular biomarkers in our Phase 1 trials and significant improvements in plaque formation and dyslipidemia in established mouse models, together with the growing recognition of systemic inflammation as a cardiovascular risk factor as recently demonstrated in the JUPITER study, support an expanded strategy for the development of XOMA 052 in cardiovascular diseases," said Patrick J. Scannon, M.D., Ph.D., XOMA's Executive Vice President and Chief Medical Officer.
"Despite many recent advances in prevention and treatment, cardiovascular disease remains the leading cause of death in the United States, demonstrating the ongoing need for new therapies," said Steven B. Engle, XOMA's Chairman and Chief Executive Officer. "While we remain focused on developing XOMA 052 in Type 2 diabetes, we believe expanding our development strategy to include cardiovascular diseases, to be implemented as resources permit, will lay the groundwork to dramatically expand the potential for this product candidate."
Inflammation is a critical component of many diseases and IL-1 has been demonstrated to be one of the key cytokines involved in the pro-inflammatory process. At normal physiological levels, IL-1 is an important part of the host defense system. In elevated amounts, IL-1 has been demonstrated to have a pathologic role in initiating, maintaining or exacerbating inflammatory conditions including Type 2 diabetes, cardiovascular disease, rheumatoid arthritis, gout and other diseases.
References
About XOMA 052
XOMA 052 is potent antibody with the potential to improve the treatment of patients with a wide variety of inflammatory diseases. XOMA 052 binds strongly to IL-1 beta, a pro-inflammatory cytokine involved in the development of Type 2 diabetes, cardiovascular disease, rheumatoid arthritis, gout and other diseases. By binding to IL-1 beta, XOMA 052 inhibits the activation of the IL-1 receptor, thereby reducing the cellular signaling events that produce inflammation. XOMA 052 has a half-life of 22 days. Based on its binding properties, specificity to IL-1 beta and half-life, XOMA 052 may provide convenient dosing of once per month or less frequently.
XOMA developed XOMA 052 using the company's proprietary antibody technologies, capabilities and expertise. XOMA owns worldwide rights to the antibody and related intellectual property. The company is actively pursuing a partnership for the development and commercialization of XOMA 052.
News item 2 - Phase 2 Trial of XOMA 052 to be Initiated in Type 1 Diabetes Patients
8:04a ET November 4, 2009 (GlobeNewswire)
XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced plans to initiate an investigator sponsored Phase 2 clinical trial of XOMA 052, its antibody to interleukin-1 beta (IL-1 beta), in Type 1 diabetes patients. The trial will be sponsored by the Juvenile Diabetes Research Foundation International (JDRF), the largest patient advocacy organization of Type 1 diabetes research worldwide. The trial sponsor is Dr. Marc Donath, Professor of Endocrinology and Diabetes at the University Hospital of Zurich, pioneer in anti-inflammatory approaches to diabetes treatment, and a principal investigator in the Phase 1 studies of XOMA 052. XOMA will provide XOMA 052 drug product for the trial.
The study is designed to evaluate the effect of anti-inflammatory treatment in Type 1 diabetes patients after the initial period of autoimmune activity that results in the loss of blood sugar level control, attempting to prevent the complete loss of beta cells. It follows an initial study indicating that anti-IL-1 drugs may have positive benefit for patients with Type 1 diabetes. The randomized, placebo-controlled study in 24 patients with well-controlled Type 1 diabetes who have had the disease for at least two years will measure the effects of treatment with XOMA 052 over six months on beta cell function and insulin production. The safety, tolerability, and pharmacokinetics of XOMA 052 will also be assessed.
"The evaluation of our general anti-inflammatory drug candidate, XOMA 052, in multiple diseases continues to expand. We are pleased that Dr. Donath plans to initiate a study in Type 1 diabetes with JDRF support. In parallel, XOMA continues to focus on conducting studies of XOMA 052 in patients with Type 2 diabetes and cardiovascular disease," said Steven B. Engle, XOMA's Chairman and Chief Executive Officer. "If successful, this study would be the first showing the impact of reducing inflammation in Type 1 diabetes patients with disease duration of two years or more. It would provide additional evidence of the benefit anti-inflammatory therapy that could lead to the improvement in the lives of many patients."
According to the JDRF, as many as 3 million Americans may have Type 1 diabetes, an autoimmune disease that strikes children and adults suddenly and can be fatal. In Type 1 diabetes, the patient's own immune system destroys the patient's beta cells in their pancreas that normally control blood sugar level. Patients with Type 1 diabetes have to test their blood sugar and give themselves insulin injections multiple times each day, or use a pump every day for the rest of their lives. And even with intensive care, insulin is not a cure for diabetes, nor does it completely prevent its eventual and devastating complications, which may include kidney failure, blindness, heart disease, stroke, and amputation.
IL-1 beta has been demonstrated to be involved in the destruction of pancreatic beta cells in patients with Type 1 diabetes(1) as well as Type 2 disease(2). In Type 1 diabetes, immune cells that target a patient's pancreatic beta cells initiate the damage, which results in an increase in blood glucose levels. The higher blood glucose levels stimulate the production of the pro-inflammatory cytokine IL-1 beta which, in turn, feeds back on the pancreatic beta cells, reducing their insulin-production efficiency and eventually leading to cell death. XOMA 052 is an antibody that binds to IL-1 beta and interferes with the activation of the IL-1 receptor, thereby reducing cellular signaling events that produce pathological levels of inflammation.
"Several clinical studies are ongoing with anti-IL-1 and immune modulating agents in patients at the early stages of Type 1 diabetes, with the objective of preserving beta cell mass," said Dr. Donath. "This trial will test the novel hypothesis that inhibiting the activity of IL-1 beta may prevent ongoing beta cell death at later stages of disease, when most beta cells have been destroyed, and allow beta cell regeneration to prevail and repopulate the pancreas. I am very excited about the potential for an anti-inflammatory treatment for our patients with Type 1 diabetes."
"A key part of JDRF's research is aimed at stopping or reversing the immune system response that causes diabetes: the attack on insulin-secreting cells in the pancreas," said Patricia Kilian, Ph.D., Director of Regeneration at JDRF. "This attack must be stopped so that any therapies involving replacing or regenerating insulin-producing cells can work long-term. We are hopeful that this study will further advance this promising line of research to the benefit of Type 1 diabetes patients."
News Item 1 - XOMA Granted First European Patent Covering XOMA 052
8:03a ET November 4, 2009 (GlobeNewswire)
XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced the grant of its first European Patent related to the XOMA 052 program. Granted by the European Patent Office, the patent covers XOMA's interleukin-1 beta (IL-1 beta) antibody XOMA 052, as well as nucleic acids, expression vectors and production cell lines for the manufacture of XOMA 052. The patent provides exclusivity in Europe into 2026.
IL-1 beta is a pro-inflammatory cytokine involved in the development of Type 2 diabetes, cardiovascular disease, rheumatoid arthritis, gout and other diseases. By binding to IL-1 beta, XOMA 052 inhibits the activation of the IL-1 receptor, thereby preventing the cellular signaling events that produce inflammation. Earlier this year, XOMA completed successful Phase 1 trials of XOMA 052 in Type 2 diabetes patients, and has initiated its Phase 2 clinical development program in Type 2 diabetes and cardiovascular disease.
"This new patent is XOMA's first European patent providing exclusivity for XOMA 052 and complements our two U.S. Patents, which issued earlier this year," said Steven Engle, XOMA Chairman and Chief Executive Officer.
XOMA Signs Antibody Discovery Collaboration With Kaketsuken
8:02a ET November 3, 2009 (GlobeNewswire)
XOMA Ltd. (Nasdaq:XOMA) and Kaketsuken have entered into a collaboration involving multiple proprietary XOMA antibody research and development technologies, including a new XOMA antibody phage display library, and a suite of integrated information and data management systems. Subject to certain technical verification required under the collaboration agreement, Kaketsuken has agreed to pay XOMA a fee of $8 million and XOMA will be entitled to milestone payments and royalties on product sales. Founded in 1926 in Japan as the Chemo-Sero-Therapeutic Research Institute, Kaketsuken, a research foundation with current annual revenues of approximately US $350 million, has blood plasma products, vaccines and therapeutics and is developing therapeutic solutions for infectious, and other diseases.
"Antibody technologies are increasingly important in the development of novel therapeutics for a wide range of diseases so it is essential to find the best technologies and partners to maximize the chances for success," said Dr. Hiroshi Mizokami, Executive Director of Kaketsuken. "With XOMA's successful record of antibody candidates and drug development relationships, we are confident that they can provide us with the technologies we need to accelerate our antibody development programs. We look forward to a mutually beneficial relationship."
The centerpiece of the collaboration is access to a highly diverse antibody phage display library constructed by XOMA. Phage display libraries enable rapid generation and screening of large numbers of candidate antibodies and antibody fragments to select for optimal binding and other characteristics. XOMA's new, proprietary antibody phage display library is one of a new category of libraries being developed by XOMA scientists to overcome existing limitations in library design by combining very high diversity and "best in class" techniques with XOMA's proprietary and patent-protected technologies to enable the selection of antibodies with very specific and high affinity binding and potency characteristics to an antigen of choice.
"We are pleased to collaborate with Kaketsuken, an innovator in immunology and developer of the DPT vaccine," said Steven B. Engle, XOMA's Chairman and Chief Executive Officer. "This is the third technology collaboration XOMA has initiated this year, which combined are expected to result in fee revenue totaling $43 million and potential future milestone and royalty payments. We look forward to additional agreements that demonstrate the value of our extensive antibody expertise and increase the return on our research and development investment."
XOMA Presents First XOMA 052 Cardiovascular Disease Animal Model Results
12:00p ET October 20, 2009 (GlobeNewswire)
XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced the presentation today of peer-reviewed results with XOMA 052, its antibody to interleukin-1 beta (IL-1 beta), at two international conferences.
Preclinical results with XOMA 052 in an animal model of cardiovascular disease were presented today at the 2009 Annual Meeting of the Society for Leukocyte Biology, International Cytokine Society, & International Society for Interferon and Cytokine Research (Tri-Society) in Lisbon, Portugal. The presentation, entitled "XOMA 052, a regulatory monoclonal antibody targeting IL-1 beta, reduces biomarkers of cardiovascular risk in animal models," included results of studies in the apolipoprotein E (ApoE) knockout mouse model, a well-validated model of atherosclerosis that follows a similar pattern of progression to that of atherosclerosis in humans.
The results demonstrated that mice treated with a murine equivalent of XOMA 052 had a statistically significant reduction in the formation of atherosclerotic lesions, also known as plaque, in the aorta (p<0.05), and trends toward improved lipid profiles, compared to mice receiving a control antibody. Results from this study and XOMA 052 animal model studies in the diet-induced obesity model are available via the home page of the XOMA web site, www.xoma.com; click on "download here" link below "Tri-Society Presentation."
"These new results demonstrate for the first time that XOMA 052 has a direct, beneficial effect on plaque build-up in an established animal model of cardiovascular disease," said Stephen Doberstein, Ph.D., XOMA's Vice President of Research. "We are currently evaluating XOMA 052 in animal models of acute and chronic cardiovascular disease and anticipate these results will provide further support for our XOMA 052 development program."
Additionally, the company presented the results of its U.S. Phase 1 clinical trial of XOMA 052 in Type 2 diabetes at the International Diabetes Federation's (IDF) World Diabetes Conference in Montreal, Canada in a poster presentation entitled "XOMA 052, a potential disease-modifying anti-interleukin-1 beta (IL-1 beta) regulatory antibody, shows reductions in hs-CRP, HbA1c and FPG after subcutaneous injection in a randomized, blinded, placebo-controlled trial in subjects with type 2 diabetes." Results from this trial were announced on July 14 and are available via the home page of the XOMA website, www.xoma.com; click on the "download here" link below "XOMA 052 Phase 1 Results." These results support initiation of the Phase 2 clinical development program in diabetes and cardiovascular disease.
About XOMA 052
XOMA 052 is a potent monoclonal antibody with the potential to improve the treatment of patients with a wide variety of inflammatory diseases. XOMA 052 binds strongly to IL-1 beta, a pro-inflammatory cytokine involved in the development of Type 2 diabetes, cardiovascular disease, rheumatoid arthritis, gout and other diseases. By binding to IL-1 beta, XOMA 052 inhibits the activation of the IL-1 receptor, thereby preventing the cellular signaling events that produce inflammation. XOMA 052 has a half-life of 22 days. Based on its binding properties, specificity to IL-1 beta and half-life, XOMA 052 may provide convenient dosing of once per month or less frequently.
XOMA developed XOMA 052 using the company's proprietary antibody technologies, capabilities and expertise. XOMA owns worldwide rights to the antibody and related intellectual property. The company is actively pursuing a partnership for the development and commercialization of XOMA 052.
He has a distaste for Jeff. Rad wanted to get control of the company and reverse split the crap out of it and leave everyone else out in the cold, where Jeff has tried to make it into a viable entity without screwing the average Joe like you and I.
Appreciate you sharing the feedback Race.
Mikey, your going to be rich!!!!
Damn, I only have two blocks to represent the day of the month on my fancy desk dust collector. What am I going to do tomorrow? LOL
Hey Tex, this has been one long July and it's turning cold. First time I ever remember seeing frost on the grass in July. Hopefully Rick will bring July to a close soon. LOL
Quinn, The board is very quiet awaiting your reporting. Give it to us bud, I can't take the tension any longer! LOL
Can't Quinn, Freebie.
News---
XOMA Announces Initiation of Its Phase 2 Clinical Program for XOMA 052 in Type 2 Diabetes and Cardiovascular Disease
http://finance.yahoo.com/news/XOMA-Announces-Initiation-of-pz-909682553.html?x=0&.v=1
HUH!!! 321+ mil traded so far.
All of those sellers should be checking the news before they sell!
XOMA Completes Full Repayment of Goldman Sachs Loan
2:52p ET September 24, 2009 (GlobeNewswire)
XOMA Ltd. (Nasdaq:XOMA) today announced that it has fully repaid its loan from Goldman Sachs Specialty Holdings, Inc. Repayment of the loan discharged all of XOMA's obligations to the lenders. The repayment resolves the uncertainty about the loan that arose from the sudden and unexpected withdrawal of RAPTIVA(R) from the market earlier this year, which triggered XOMA to begin to renegotiate the loan that was secured by royalties from RAPTIVA(R), LUCENTIS(R) and CIMZIA(R).
"We are pleased to have successfully concluded this matter. We have strengthened our financial condition by removing a burden on our balance sheet, eliminating interest costs and improving XOMA's freedom to operate," said Steven B. Engle, XOMA's Chairman and Chief Executive Officer. "Using the LUCENTIS(R) royalty buyout payment to help fund the loan repayment is non-dilutive to shareholders and removes potential uncertainties related to LUCENTIS's(R) future. Eliminating the loan overhang will also strengthen our position in negotiating future collaborations, including our antibody technology collaborations and a corporate partnership for XOMA 052."
XOMA repaid the entire $44.3 million in principal and interest on the loan with proceeds from: a $25 million buyout by Genentech of XOMA's royalty interest in LUCENTIS(R); an equity offering of $12.3 million; the restricted cash account reserved for loan repayment containing $6.1 million; and $0.9 million from XOMA's cash reserves. In addition, XOMA was required to pay a prepayment penalty of 6% of the loan balance, or $2.5 million, from its cash reserves.
"Based on estimated revenues and expenses and without including an anticipated corporate partnership for XOMA 052, we estimate our cash resources after full payment of the loan are sufficient to fund operations into the first quarter of 2010," said Fred Kurland, XOMA's Vice President, Finance and Chief Financial Officer. "As a result of the loan repayment, we have eliminated future interest charges that would have totaled $5.1 million in 2009, freed up the future flow of royalty income from CIMZIA(R) sales for use in funding company operations and avoided restructuring costs and future loan constraints."
XOMA receives royalties from UCB, S.A. based on U.S. and Swiss sales of CIMZIA(R), which is being launched in the U.S. for the treatment of rheumatoid arthritis and is approved for treatment of Crohn's disease.