Aphton Corporation Reports Fourth Quarter and Year End 2004 Financial Results and Developments.PHILADELPHIA -- Aphton Corporation (Nasdaq:APHT APHT Advance Physical Test ) today announced financial results for the fourth quarter and year ended December 31, 2004. The Company also highlighted several noteworthy milestones defined by significant progress in operations, research and development and finance. Highlights include: --The signing of a worldwide collaboration agreement for the treatment of gastrointestinal and other gastrin-sensitive cancers using anti-gastrin monoclonal antibodies This is a list of monoclonal antibodies, antibodies which are clones of a single parent cell. When used as medications, the generic names end in -mab (see "Nomenclature of monoclonal antibodies"). with Xoma Ltd (NASDAQ:XOMA); --The signing of a collaboration and licensing agreement for the development, manufacturing and commercialization of gastrin-related diagnostic kits with Daiichi Pure Chemicals; --The completion and reporting of positive results related to the randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the of Insegia(TM) (G17DT immunogen) as a monotherapy monotherapy /mono·ther·a·py/ (-ther´ah-pe) treatment of a condition by means of a single drug. mon·o·ther·a·py n. Treatment of a disorder with a single drug. versus placebo for the treatment of patients with pancreatic cancer pancreatic cancer Malignant tumour of the pancreas. Risk factors include smoking, a diet high in fat, exposure to certain industrial products, and diseases such as diabetes and chronic pancreatitis. Pancreatic cancer is more common in men. ; --The filing for marketing approval of the Company's lead anti-cancer compound, Insegia as a therapeutic option for patients with advanced pancreatic cancer who are either unable to tolerate or elect not to take chemotherapy to regulatory agencies regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. in Switzerland, Canada and Australia; --The appointment of key members to the management team and to the Board of Directors; and --The strengthening of the Company's balance sheet through raising net proceeds Net Proceeds The amount received after all costs are deducted from the sale of a piece of property or security. Notes: In the case of an investor selling a security, net proceeds represent the proceeds from the sale minus any trading costs (i.e. commissions). of $48.6 million. The Company has rounded out these accomplishments with its more recent events, which also include: --The announcement of the intent to acquire Igeneon, a privately held, late-stage immunotherapy Immunotherapy The treatment of cancer by improving the ability of a tumor-bearing individual (the host) to reject the tumor immunologically. There are molecules on the surface of tumor cells, and perhaps in their interior, that are recognized as different from company whose pipeline could significantly complement and solidify so·lid·i·fy v. so·lid·i·fied, so·lid·i·fy·ing, so·lid·i·fies v.tr. 1. To make solid, compact, or hard. 2. To make strong or united. v.intr. Aphton's immunotherapy program; --The announcement of preliminary results of the randomized Phase III clinical trial of Insegia in combination with chemotherapy for the treatment of chemotherapy naive patients with advanced pancreatic cancer; and --The hiring and appointment of additional key members of the management team. "As we look back over the year it is important to recognize the significant progress related to so many aspects of our business," commented Dr. Patrick Mooney, President, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. and Chairman of Aphton. "Although significant headway head·way n. 1. Forward movement or the rate of forward movement, especially of a ship. 2. Progress toward a goal. 3. The clear vertical space beneath a ceiling or archway; clearance. 4. has been made, we continue to evaluate the Company's operations as well as research and development programs with the intent of prioritizing programs and conserving capital. We anticipate that we will be in a position to detail these cost-saving changes in the coming weeks. We are more committed than ever to providing our shareholders with a strong foundation for the future of the Company. While we recognize the disappointment of the preliminary findings of the recent Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA study of Insegia we believe that the data not only supports our monotherapy applications but, validates our immunotherapeutic im·mu·no·ther·a·py n. pl. im·mu·no·ther·a·pies Treatment of disease by inducing, enhancing, or suppressing an immune response. im approach to gastrin-sensitive cancers, and that the future is bright for Aphton and our shareholders." "We fully support the pending acquisition of Igeneon, as we see it as a key driver for future pipeline growth," commented Jim Smith There are several famous people with the name Jim Smith, including:
Product Development Highlights Insegia(TM)(G17DT Immunogen) In June 2004 the Company presented data from its first randomized phase III trial of Insegia(TM) (G17DT immunogen) versus placebo for the treatment of chemotherapy naive patients with pancreatic cancer at the Annual American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. (ASCO ASCO American Society of Clinical Oncology ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland) ASCO Australian Standard Classification of Occupations ASCO Automatic Switch Company ). 154 patients were randomly assigned to receive either Insegia alone or placebo. Results of the study showed that: --Treatment with Insegia resulted in a median survival of 150 days compared with 83 days for patients treated with the placebo (p=0.030, log rank). --Patients treated with Insegia showed a significantly longer time to deterioration de·te·ri·o·ra·tion n. The process or condition of becoming worse. of Karnofsky score (a known assessment of a patient's ability to function, and a predictor of prognosis prognosis /prog·no·sis/ (prog-no´sis) a forecast of the probable course and outcome of a disorder.prognos´tic prog·no·sis n. pl. prog·no·ses 1. ), with a median of 138 days vs. 78 days with the placebo (p=0.038, Wilcoxon). --Importantly, patients who generated anti-G17 antibodies (those defined as "Insegia responders") lived significantly longer than both patients who did not generate anti-G17 antibodies and patients who received placebo. Analysis of the Kaplan Meier plots showed that antibody responders to Insegia had a median survival of 176 days compared to 63 days for non-responders and to 83 days for the placebo group (p=0.003, log rank homogeneity Homogeneity The degree to which items are similar. test). --Insegia treatment was seen to be safe and well tolerated, with no unexpected differences between study arms. This data became the foundation for the Company's first applications for marketing approval for the registration of Insegia as monotherapy in patients with advanced pancreatic cancer who are either unable to tolerate or elect not to take chemotherapy. Applications for marketing approval have been filed in Switzerland, Canada and Australia. The Company expects to hear from regulatory authorities Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest regulatory agency administrative body, administrative unit - a unit with administrative responsibilities related to these applications in the first half of 2005 for Switzerland, in mid-2005 from Australia and in the second half of 2005 from Canada. In February 2005 the Company released top-line preliminary data from its randomized trial of Insegia in combination with gemcitabine (Gemzar(R), EliLilly) for the treatment of chemotherapy naive patients with advanced pancreatic cancer. While Insegia did not meet the primary endpoint, the Company was encouraged by results observed in patients who achieved an antibody response, in this case approximately 70% of patients. These patients demonstrated prolonged pro·long tr.v. pro·longed, pro·long·ing, pro·longs 1. To lengthen in duration; protract. 2. To lengthen in extent. survival over patients treated in the control arm with chemotherapy alone, as well as over patients who did not achieve an antibody response. Because the data continues to be preliminary the Company is continuing the evaluation of these results as well as other pre-specified secondary endpoints. The Company has submitted a "late-breaking" abstract for this trial to the upcoming ASCO meeting that will take place in May. Strategic Collaborations --In June Aphton signed a collaboration and license agreement with Daiichi Pure Chemicals Co., Ltd. for the development, manufacturing, and commercialization of gastrin-related diagnostic kits. Under the Agreement, Daiichi will develop diagnostic kits based on assays and monoclonal antibodies developed by Aphton. Daiichi will have exclusive worldwide manufacturing and supply rights and will commercialize the kits by itself or with specialized distributors in Asia. Aphton retains the rights to commercialize the kits by itself or with specialized distributors, outside of Asia. --In September the Company signed a worldwide collaboration agreement with Xoma (US) LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control for the treatment of gastrointestinal and other gastrin-sensitive cancers using anti-gastrin monoclonal antibodies. Under the terms of the agreement, Aphton and XOMA are to share all development expenses and all commercialization profits and losses for all product candidates on a 70/30 basis, respectively. XOMA will have worldwide manufacturing rights for these products and the ability to share up to 30% in the commercialization efforts in the U.S. in accordance with the terms of the agreement. Aphton will have exclusive rights to commercialize all products outside the U.S. Operations During the year, and more recently, the Company's senior team was significantly strengthened by the appointment of a number of key leaders, including: --Patrick Mooney, M.D., as President, Chairman and Chief Executive Officer; --James Smith, CPA (Computer Press Association, Landing, NJ) An earlier membership organization founded in 1983 that promoted excellence in computer journalism. Its annual awards honored outstanding examples in print, broadcast and electronic media. The CPA disbanded in 2000. , a 30-year veteran of accounting and finance, as Senior Vice President and Chief Financial Officer; --Susan Anne Watson, Ph.D., an 18 year veteran of cancer research, as Senior Vice President and Chief Scientific Officer; and --The Company also appointed Vincent D. Enright, former Chief Financial Officer of Keyspan Corporation, as a new member of the Board of Directors. Financial Strength Cash, cash equivalents, and short-term investments totaled $43.4 million as of December 31, 2004, compared to $49.4 million at the end of the 3rd quarter of 2004 and compared to $19.2 million as of December 31, 2003. In the 4th quarter ended December 31, 2004, the Company's net loss applicable to common shareholders was $8.6 million, or $(0.23) per share, compared to a loss of $6.6 million, or $(0.23) per share for the same period in 2003. For the year ended December 31, 2004, the Company reported a net loss applicable to common shareholders of $28.8 million, or $(0.79) per common share, compared to a net loss of $26.3 million, or $(1.02) per common share, for the corresponding period in 2003. In the 4th quarter, total operating costs operating costs npl → gastos mpl operacionales and expenses increased from $6.1 million in 2003 to $8.1 million in 2004. For the year ended December 31, 2004, total operating costs and expenses of $(26.7) million increased by $2.1 million compared with the comparable period in 2003. The increase in both the 4th quarter and full year operating costs and expenses was due primarily to increase in Sarbanes-Oxley compliance costs, professional fees, premiums for our director and officer insurance policy and an increase in salary and benefits of our administrative personnel. Strategic Pipeline Aphton continues to focus its efforts on broadening and progressing its research and development pipeline. An important element of this strategy is its potential acquisition of Igeneon, a biopharmaceutical company with a diverse pipeline of late-stage products including active and passive immunotherapies. Aphton believes that immunotherapies may have certain advantages over other targeted therapies by including specificity that may lead to better efficacy and decreased toxicities for patients. About Aphton Aphton Corporation, headquartered in Philadelphia, Pennsylvania is a clinical stage biopharmaceutical company focused on developing targeted immunotherapies for cancer and other diseases. The Company's products seek to neutralize neutralize to render neutral. hormones involved in the growth and proliferation proliferation /pro·lif·er·a·tion/ (pro-lif?er-a´shun) the reproduction or multiplication of similar forms, especially of cells.prolif´erativeprolif´erous pro·lif·er·a·tion n. of cancers as well as other diseases. The company's lead product, Insegia(TM) (G17DT immunogen) is currently in development both as a monotherapy for pancreatic cancer and in combination with chemotherapy for the treatment of gastric cancer gastric cancer Stomach cancer, see there . Aphton has strategic alliances with sanofi-aventis for the development and commercialization of Insegia related to cancers of the gastrointestinal system gastrointestinal system: see digestive system. and other cancers in North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. and Europe; Daiichi Pure Chemicals for the development, manufacturing and commercialization of gastrin-related diagnostic kits; and Xoma for treating gastrointestinal and other gastrin-sensitive cancers using anti-gastrin monoclonal monoclonal /mono·clo·nal/ (-klon´al) 1. derived from a single cell. 2. pertaining to a single clone. mon·o·clo·nal n. and other antibodies. For more information about Aphton or its programs please visit Aphton's website at http://www.aphton.com.
Aphton Corporation
Selected Condensed Financial Data
(In thousands, except per share data)
Three Months Ended Years Ended
December 31, December 31,
----------------- -------------------
2004 2003 2004 2003
-------- -------- --------- ---------
Revenues $ - $ - $ - $ -
Costs and expenses:
General and administrative 2,973 779 5,570 2,768
Research and development 5,169 5,336 21,147 21,878
-------- -------- --------- ---------
Total cost and expenses 8,142 6,115 26,717 24,646
Loss from operations
Interest expense including
amortized discount (699) (545) (2,676) (1,851)
Interest income and unrealized
gains or losses 284 107 631 197
-------- -------- --------- ---------
Net loss (8,559) (6,553) (28,762) (26,300)
-------- -------- --------- ---------
Net loss applicable to common
shareholders (8,559) $(6,553) $(28,762) $(26,300)
======== ======== ========= =========
Basic and diluted loss per common
share $(0.23) $(0.23) $(0.79) $(1.02)
======== ======== ========= =========
Shares used in computing net loss
per share 37,797 28,778 36,285 25,791
======== ======== ========= =========
December 31,
-----------------
2004 2003
-------- --------
Cash and current investments $43,414 $19,216
Working capital 34,309 13,150
Total assets 52,635 27,246
Total stockholders' equity 20,990 (76)
Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. This press release includes forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. , including statements about: (1) the intent of the Company to identify, and its ability to implement, reductions to Aphton's and Igeneon's cash burn rate, and the timing of such implementation, (2) Aphton's belief that the results of PC(IV) will support its monotherapy applications and validates its immunotherapeutic approach to gastrin-sensitive cancers,(3) Aphton's beliefs regarding its future, (4) expectations regarding the timing of responses from regulatory agencies, (5) the completion of the potential acquisition of Igeneon by Aphton; (6) Aphton's belief that immunotherapies have certain advantages over targeted therapies and (7) Aphton's intent to expand its research and development pipeline. These forward-looking statements may be affected by the risks and uncertainties inherent in the drug development process and in Aphton's and Igeneon's business. This information is qualified in its entirety by cautionary statements and risk factor disclosure contained in Aphton's Securities and Exchange Commission filings, including Aphton's report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. filed with the Commission on March 15, 2004 and the 2004 Form 10-K that will be filed with the SEC. Aphton wishes to caution readers that certain important factors may have affected and could in the future affect Aphton's beliefs and expectations and could cause the actual results to differ materially from those expressed in any forward-looking statement made by or on behalf of Aphton. These risk factors include, but are not limited to, (1) Aphton's ability to identify and realize anticipated cost efficiencies and to reduce the combined cash burn rate, (2) Aphton's ability to fund the further development of its research and development, (3) Aphton's ability to successfully identify and consummate opportunities to broaden and progress its research and development pipeline, (4) scientific developments regarding immunotherapies and target therapies (5) Aphton's ability to consummate the pending acquisition of Igeneon, the inability to successfully integrate Igeneon's operations and product portfolio with Aphton's operations and product portfolio; and (6) the actual design, results and timing of preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. and clinical studies for both companies' products and product candidates. With respect to Aphton's expectations regarding the timing of responses from regulatory agencies, this may depend on the reaction of such governmental agencies to the preliminary results of our recent Insegia Phase III clinical trial, the final results of our analysis on such trial, and factors not within our control, such as governmental delays. |
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