PharmaFrontiers Reports Year End 2005 Financial Results.THE WOODLANDS, Texas -- PharmaFrontiers Corp. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : PFTR), a company involved in the development and commercialization of cell therapies, today reported financial results for the year ended December 31, 2005 and provided an update on its progress. Recent highlights include: --Acquisition of autologous autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism. au·tol·o·gous adj. 1. T-cell vaccine rights for rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. from the Shanghai Institutes for Biological Sciences (SIBS), Chinese Academy of Sciences The Chinese Academy of Sciences (CAS) (Simplified Chinese: 中国科学院; Pinyin: Zhōngguó Kēxuéyuàn), formerly known as Academia Sinica of the People's Republic People's Republic n. A political organization founded and controlled by a national Communist party. of China --Data on adult human T-cell and stem cell stem cell In living organisms, an undifferentiated cell that can produce other cells that eventually make up specialized tissues and organs. There are two major types of stem cells, embryonic and adult. technologies to be presented at the International Society for Cellular Therapy Annual Meeting --Company to present data at Consortium of Multiple Sclerosis Centers' Annual Meeting --Mathilda Mandel, M.D. appointed to Clinical Advisory Board David McWilliams
David McWilliams (born 1968[1]) is an Irish economist and broadcaster. , chief executive officer of PharmaFrontiers, stated, "This is been a very active and productive period for PharmaFrontiers during which we have made significant progress on multiple fronts including clinical, scientific and financial. We are ramping up to start our Phase IIb clinical trial for multiple sclerosis and anticipate that it will begin shortly. In addition, we continue to have our stem cell and T-cell data accepted for presentation at important scientific and medical venues. We broadened our Company's technology base and potential future revenue base by acquiring the worldwide license from SIBS, which offers us the opportunity to develop a safe and effective T-cell vaccine for rheumatoid arthritis." Mr. McWilliams added, "On the financial front, we are working diligently to close an equity financing Equity Financing The act of raising money for company activities by selling common or preferred stock to individual or institutional investors. In return for the money paid, shareholders receive ownership interests in the corporation. that will significantly strengthen our cash reserves Cash reserves See: Cash investments cash reserves Investment funds that are held in short-term assets such as Treasury bills and certificates of deposit until more permanent investment opportunities are available. , giving us the necessary financial flexibility to execute our clinical program. This includes the completion of the Phase IIb clinical trial for Tovaxin(TM), initiation of Phase I clinical trials Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I for the treatment of rheumatoid arthritis using a T-cell vaccine approach and completion of pre-clinical development Pre-clinical development is a stage in the development of a new drug that begins before clinical trials (testing in humans) can begin, and during which important safety and pharmacology data is collected. and filing of an IND for the use of our proprietary stem cell technology to treat type I diabetes Type I diabetes Also called juvenile diabetes. Type I diabetes typically begins early in life. Affected individuals have a primary insulin deficiency and must take insulin injections. Mentioned in: Diabetic Ketoacidosis ." Research and Development In January, 2006, PharmaFrontiers acquired an exclusive worldwide licensing for the intellectual property rights and research results of an autologous T cell vaccine for rheumatoid arthritis from the Shanghai Institutes for Biological Sciences (SIBS), Chinese Academy of Sciences of the People's Republic of China. The agreement stipulates that in exchange for an initial payment and a running royalty on the sale of commercialized products, PharmaFrontiers receives the exclusive license and all information and data relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the SIBS' Tovaxin clinical trials involving the T cell vaccine. The Company continues to present its data at prestigious conferences within the scientific and medical community. A research paper entitled, "Autologous Trivalent trivalent /tri·va·lent/ (tri-va´lent) having a valence of three. tri·va·lent adj. Having valence 3. tri·va T Cell Therapy in Multiple Sclerosis: A Study of Patients Previously Treated with Monovalent monovalent /mono·va·lent/ (-va´lent) 1. having a valency of one. 2. capable of combining with only one antigenic specificity or with only one antibody specificity. T Cell Therapy," has been accepted for a platform presentation at the 20th Consortium of Multiple Sclerosis Centers' Annual Meeting. Brian Loftus, M.D., Diagnostic Clinic of Houston, and the Company's lead clinical investigator A clinical investigator involved in a clinical trial is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under , will make the presentation. In addition, PharmaFrontiers will present three poster presentations based on the Company's adult human T-cell vaccination and stem cell regenerative re·gen·er·a·tive adj. 1. Of, relating to, or marked by regeneration. 2. Tending to regenerate. re·gen medicine platform technologies at the 2006 Annual Meeting of the International Society for Cellular Therapy (ISCT ISCT International Society of Cleaning Technicians ISCT Integrative Social Contract Theory (business ethics) ISCT International Society for Cell Therapy ) in Berlin on May 5, 2006. Corporate Developments On December 1, 2005, the Company appointed Mathilda Mandel, M.D. to its clinical advisory board. Dr. Mandel has been the director of the Blood Bank and Transfusion Center at the Sheba Medical Center The Chaim Sheba Medical Center (Hebrew: המרכז הרפואי ע"ש חיים שיבא - תל in Tel-Hshomer, Israel, since 1994. She has been involved in studying T-cell vaccination using autologous T-Cell lines generated from MS patients for several years and will be an advisor on the production of the Company's vaccine during the Phase IIb trial. Financial Information Net loss for the full year 2005 was $19.4 million, or $1.24 per share, compared with a net loss for the full year 2004 of $4.6 million, or $0.73 per share. Research and development expenses for the year ended December 31, 2005 were approximately $9.9 million, mainly reflecting the costs of the Phase I/II clinical trials for Tovaxin, pre-trial expenses for the Tovaxin Phase IIb Clinical Trial scheduled to begin in 2006 and research and development in support of pre-clinical cardiac and diabetes stem cell therapies stem cell therapy Cell therapy Molecular medicine A technology in which a person's own cells–eg, neuronal stem cells are triggered to revert to their primitive embryonic form, then redifferentiate into mature cells of various organs . Research and development expenses for the year ended December 31, 2004, were approximately $2.5 million. Interest expense was $7.3 million for the 12 months ended December 31, 2005, compared with $868,926 for the 12 months ended December 31, 2004. The increase is primarily related to the amortization of the remaining discount under the beneficial conversion feature of the Company's 15% exchangeable convertible promissory notes. The accrued interest Accrued Interest The interest that has accumulated on a bond since the last interest payment up to but not including the settlement date. There are two methods for calculating accrued interest: 1) 360-day year method, used for corporate and municipal bonds. on the notes was converted into shares of Common Stock. General and administrative expenses during the 12 months ended December 31, 2005, was $0.6 million, little changed from the previous year. The Company anticipates increases in general and administrative expenses as it continues to develop and prepare for commercialization of its technology. Cash and cash equivalents were $2.6 million as of December 31, 2005. About PharmaFrontiers Corp. PharmaFrontiers' strategy is to develop and commercialize cell therapies to treat several major disease areas such as multiple sclerosis, rheumatoid arthritis, pancreatic and cardiac conditions. PharmaFrontiers owns patented and proprietary individualized in·di·vid·u·al·ize tr.v. in·di·vid·u·al·ized, in·di·vid·u·al·iz·ing, in·di·vid·u·al·iz·es 1. To give individuality to. 2. To consider or treat individually; particularize. 3. cell therapies that are in FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Phase I/II human dose ranging clinical trials to evaluate their safety and effectiveness in treating MS. The company also holds the exclusive worldwide license for an autologous T cell vaccine for rheumatoid arthritis from the Shanghai Institutes for Biological Sciences (SIBS), Chinese Academy of Sciences of the People's Republic of China. The company also holds the exclusive worldwide license from the University of Chicago, through its prime contractor relationship with Argonne National Laboratory Argonne National Laboratory, research center, based in Argonne, Ill., 27 mi (43 km) SW of downtown Chicago, with other facilities at the Idaho National Engineering Laboratory, 50 mi (80 km) W of Idaho Falls, Idaho. Founded in 1946 by the U.S. , for patents relating to the use of adult pluripotent stem cells pluripotent stem cell Hematology The 'mother of all cells'–the progenitor of all hematopoietic cells–eg, platelets, RBCs, neutrophils, macrophages, lymphocytes. See Stem celll. derived from patients' own circulating blood. 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. Statement This press release contains "forward-looking statements," including statements about PharmaFrontiers' growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. These forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to PharmaFrontiers' ability to obtain additional funding, develop its stem cell technologies, achieve its operational objectives, and obtain patent protection for its discoveries, that may cause PharmaFrontiers' actual results to be materially different from any future results expressed or implied by such forward-looking statements. PharmaFrontiers undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
PHARMAFRONTIERS CORP.
(a development stage company)
CONSOLIDATED BALANCE SHEET
December 31, 2005
ASSETS
Current assets
Cash $2,560,666
Prepaid expenses 182,524
-------------------
Total current assets 2,743,190
Intangible assets, net of $1,888,891 of
accumulated amortization 26,130,441
Property & equipment, net of $256,082 of
accumulated depreciation 479,996
Other assets 388,210
-------------------
Total assets $29,741,837
===================
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable $689,467
Accrued expenses 240,309
Note payable 1,500,000
-------------------
Total current liabilities 2,429,776
-------------------
Commitments and contingencies -
Stockholders' equity
Convertible preferred stock, no par value,
10,000,000 shares authorized, none issued
and outstanding -
Common stock, $.05 par value, 100,000,000
shares authorized, 20,619,545 shares issued
and outstanding 1,030,977
Additional paid in capital 50,441,948
Deficit accumulated during the development stage (24,160,864)
-------------------
Total stockholders' equity 27,312,061
-------------------
Total liabilities and stockholders' equity $29,741,837
===================
PHARMAFRONTIERS CORP.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF EXPENSES
Years ended December 31, 2005 and 2004 and the
Period from January 22, 2003 (Inception) to December 31, 2005
Inception
through
2005 2004 2005
-------- -------- ------------
General and
administrative $550,178 $572,534 $1,203,513
Depreciation
and amortization 1,735,209 264,819 2,000,028
Research and
development 9,892,253 2,465,634 12,357,887
Loss on disposal
of assets 22,810 457,122 479,932
-------------- ------------ --------------
Operating loss (12,200,450) (3,760,109) (16,041,360)
Interest income 81,930 5,992 87,922
Other income 28,174 2,379 30,553
Interest expense (7,323,851) (868,926) (8,237,979)
-------------- ------------ --------------
NET LOSS $(19,414,197) $(4,620,664) $(24,160,864)
============== ============= ==============
Basic and diluted
loss per share $(1.24) $(0.73) N/A
Weighted average
shares outstanding 15,648,365 6,309,145 N/A
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