XOMA Highlights Recent Achievements and Reports Financial Results for First Quarter 2013
- Announced encouraging interim results from gevokizumab Phase 2 study for moderate to severe acne vulgaris, the first indication in a program of three proof-of-concept ("POC") studies for gevokizumab. The data generated supports further development in this indication.
- Focused on advancing the gevokizumab Phase 3 EYEGUARD™ pivotal studies in non-infectious uveitis ("NIU").
- Advanced the second gevokizumab Phase 2 POC study in patients with erosive osteoarthritis of the hand ("EOA").
Tom Kleinas Vice President, Chief Commercial Officer, a newly created position.
"We focused our first quarter activities on advancing the gevokizumab Phase 3 pivotal studies in patients with NIU and on executing our second gevokizumab proof-of-concept study in patients with erosive osteoarthritis of the hand. Based upon the enrollment in the EOA study, we anticipate receiving the top-line data around
"The second highlight of our first quarter was attracting
Research and development expenses for the first quarter of 2013 were
The company reconfirmed its anticipated cash used in ongoing operating activities during 2013 will be approximately $50 million, primarily reflecting the costs associated with conducting the EYEGUARD-A, EYEGUARD-B and EYEGUARD-C Phase 3 clinical trials. This guidance initially was provided on
Investor Conference Call and Webcast
Telephone numbers for the live audiocast are 877-369-6589 (U.S./
Gevokizumab is a potent monoclonal antibody with unique allosteric modulating properties and the potential to treat patients with a wide variety of inflammatory and other diseases. Gevokizumab binds strongly to interleukin-1 beta (IL-1 beta), a pro-inflammatory cytokine that has been shown to be involved in non-infectious uveitis, including Behçet's uveitis, cardiovascular disease, and other auto-inflammatory diseases. By binding to IL-1 beta, gevokizumab inhibits the activation of the IL-1 receptor, thereby modulating the cellular signaling events that produce inflammation. Gevokizumab has been studied in over 500 patients, with approximately 300 patients on treatment for six months, and has been shown to be well-tolerated. Information about gevokizumab clinical studies can be found at www.clinicaltrials.gov.
XOMA combines a portfolio of innovative therapeutic antibodies, both in late-stage clinical development and in preclinical research, with its recently launched commercial operations. XOMA focuses its antibody research and development on allosteric modulation, which offers opportunities for new classes of therapeutic antibodies to treat a wide range of human diseases. XOMA is developing its lead product gevokizumab (IL-1 beta modulating antibody) with Servier through a global Phase 3 program in non-infectious uveitis and ongoing proof-of-concept studies in other IL-1-mediated diseases. XOMA's scientific research also produced the XMet program, which consists of three classes of preclinical antibodies, including Selective Insulin Receptor Modulators (SIRMs) that could have a major effect on the treatment of diabetes.
More detailed information can be found at www.xoma.com.
Certain statements contained in this press release including, but not limited to, statements related to anticipated timing of initiation and completion of clinical trials and proof-of-concept trials, anticipated size of clinical trials, continued sales of approved products, sufficiency of our cash resources and anticipated levels of cash utilization, 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, and 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. Potential risks to XOMA meeting these expectations are described in more detail in XOMA's most recent filing on Form 10-K and in other SEC filings. Consider such risks carefully when considering XOMA's prospects. Any forward-looking statement in this press release represents XOMA's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA disclaims any obligation to update any forward-looking statement, except as required by applicable law.
|CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS|
|(in thousands, except per share amounts)|
Three months ended
|License and collaborative fees||$ 399||$ 1,014|
|Contract and other||8,796||8,844|
|Net product sales||258||7|
|Research and development||16,590||15,771|
|Selling, general and administrative||4,124||4,679|
|Cost of sales||46||--|
|Total operating expenses||20,777||24,227|
|Loss from operations||(11,324)||(14,362)|
|Other income (expense):|
|Other income (expense)||449||(664)|
|Revaluation of contingent warrant liabilities||(12,840)||(14,357)|
|Net loss before taxes||$ (24,887)||$ (30,425)|
|Basic and diluted net loss per share of common stock||$ (0.30)||$ (0.69)|
|Shares used in computing basic and diluted net loss per share of common stock||82,595||44,353|
|Other comprehensive loss:|
|Net loss||$ (24,887)||$ (30,425)|
|Net unrealized gains on available-for-sale securities||3||--|
|Comprehensive loss||$ (24,884)||$ (30,425)|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|(in thousands, except share and per share amounts)|
|Cash and cash equivalents||$ 50,379||$ 45,345|
|Trade and other receivables, net||6,270||8,249|
|Prepaid expenses and other current assets||3,062||2,256|
|Total current assets||79,707||95,837|
|Property and equipment, net||7,861||8,143|
|Total assets||$ 88,946||$ 105,676|
|LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY|
|Accounts payable||$ 4,194||$ 3,867|
|Accrued and other liabilities||5,410||13,045|
|Interest bearing obligation — current||4,085||3,391|
|Accrued Interest on interest bearing obligations — current||1,662||121|
|Total current liabilities||19,107||23,833|
|Deferred revenue — long-term||5,857||6,315|
|Interest bearing obligations — long-term||37,017||37,653|
|Contingent warrant liabilities||27,841||15,001|
|Other liabilities - long term||33||1,407|
|Stockholders' (deficit) equity:|
|Additional paid-in capital||980,467||977,962|
|Accumulated comprehensive income||11||8|
|Total stockholders' (deficit) equity||(909)||21,467|
|Total liabilities and stockholders' (deficit) equity||$ 88,946||$ 105,676|
|Contingent warrant liabilities||
|Balance at December 31, 2011||
|Net increase in fair value of contingent warrant liabilities upon revaluation||12,840|
XOMA Corporation Companyand Investor Contact: Ashleigh Barreto510-204-7482 firstname.lastname@example.org Juliane Snowden The Oratorium Group, LLCjsnowden@oratoriumgroup.com Media Contact: Canale Communications Carolyn Hawley619-849-5375 email@example.com
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