PharmaFrontiers Reports Third Quarter 2005 Financial Results; Provides Update on Research & Development Activities.THE WOODLANDS, Texas -- PharmaFrontiers Corp (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : PFTR), a company involved in the development of novel cell therapies, including one for Multiple Sclerosis which is about to enter Phase IIb clinical trials, announced today its financial results for the three and nine month periods ended September 30, 2005, as well as providing an update on its research programs and future plans. Highlights during the third quarter of 2005 and recent weeks included: --Positive interim research findings of PharmaFrontiers' Phase I/II clinical trials of Tovaxin(TM) presented at the 21st European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS ECTRIMS European Committee for Treatment and Research in Multiple Sclerosis ) and the 10th Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS ACTRIMS Americas Committee for Treatment and Research in Multiple Sclerosis (Canada and US) ) congress held in Thessaloniki, Greece; --PharmaFrontiers Tovaxin Phase IIb Multiple Sclerosis Clinical Trial Protocol A Clinical Trial Protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical trial. The protocol usually also gives the background and reason the trial is being conducted, but these could be provided in accepted by the U.S. Food and Drug Administration's (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. ) Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the Food and Drug Administration, which is in the United States Department of Health and Human Services. (CBER CB·er n. One that uses a CB radio. ); --Election of Brooks Boveroux as chairman of the board and the reconstitution of the Company's audit committee with Mr. Boveroux as its chairman; --Retention of MDB (Message-Driven Bean) An Enterprise JavaBean (EJB) generated by the Java Messaging Service. See EJB. Capital Group to serve as the Company's financial advisor. Research and Development In October, the Company presented positive interim research findings of its Phase I/II clinical trials of Tovaxin at the 21st European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and the 10th Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) congress held in Thessaloniki, Greece. The trial results indicated that the treatment appeared safe and well tolerated with no dose-limiting toxicities, and that Tovaxin depletes the myelin-peptide reactive T cells T cells A type of white blood cell produced in the thymus gland. T cells are an important part of the immune system. Infants born with an underdeveloped or absent thymus do not have a normal level of T cells in their blood. that may contribute to the Multiple Sclerosis (MS) disease processes. More recently, PharmaFrontiers announced that the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) had approved the protocol for its Phase IIb clinical trial of Tovaxin. PharmaFrontiers will be conducting the Phase IIb with its clinical development partner, INC Research INC Research is a contract research organization headquartered in the North Carolina Research Triangle in Raleigh, North Carolina, United States.[1] The company has 26 locations in 36 countries. , Raleigh, NC. The Company expects to commence this pivotal Phase IIb study by the end of 2005 or early 2006. This multicenter, 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. , double blind, placebo-controlled Phase IIb clinical study is designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T Cell therapy with clinically isolated syndrome (CIS Cis (sĭs), same as Kish (1.) (1) (CompuServe Information Service) See CompuServe. (2) (Card Information S ) and early relapsing-remitting MS (RR-MS) patients. Additionally, the study of these patients will evaluate biomarkers of Tovaxin's efficacy and to evaluate the effect of Tovaxin on immune deviation and epitope epitope: see immunity. spreading. David McWilliams
David McWilliams (born 1968[1]) is an Irish economist and broadcaster. , chief executive officer of PharmaFrontiers Corp, commented, "The Tovaxin clinical program continues to show promising results and this `green light' from the FDA is a significant milestone for us. We believe that the protocol design will allow us to study the clinical effects of Tovaxin in a group of patients requiring a safe and effective therapy. More importantly, we also believe that the successful completion of this Phase IIb clinical trial will allow us to launch a 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 pivotal trial, bringing us towards our ultimate goal in allowing the power of our technology to treat those who are afflicted af·flict tr.v. af·flict·ed, af·flict·ing, af·flicts To inflict grievous physical or mental suffering on. [Middle English afflighten, from afflight, with Multiple Sclerosis." Recent Events The Company recently announced the unanimous election of Brooks Boveroux as chairman of PharmaFrontiers' board of directors. Mr. Boveroux, age 62, previously served as interim chairman. In addition to his duties as chairman, Mr. Boveroux has assumed primary responsibility in leading the Company in its finance and capital-raising activities as well as its efforts in the public markets. This builds upon Mr. Boveroux's significant and proven expertise in guiding the finance activities of companies in the biotechnology industry. Mr. Boveroux previously served as VP of finance and CFO See Chief Financial Officer. for companies such as Biogen, ImClone Systems ImClone Systems Incorporated (NASDAQ: IMCL) is a biopharmaceutical company dedicated to developing biologic medicines in the area of oncology. It was founded in 1984 and is headquartered in New York City. It is traded on the NASDAQ stock exchange under the symbol IMCL. and The Liposome liposome (lī`pəsōm', lĭp`ə–), microscopic, fluid-filled pouch whose walls are made of layers of phospholipids identical to the phospholipids that make up cell membranes. Company all of which grew to become significant Nasdaq listed companies. Mr. Boveroux also serves as chairman of the audit committee. "I am very enthusiastic about my election as chairman given the opportunities that lie ahead, as PharmaFrontiers prepares to implement its Phase IIb clinical trials of Tovaxin," stated Brooks Boveroux, chairman of PharmaFrontiers. "Our board is relatively new, with all of our independent directors having served for less than one year. The other board members and I are looking forward to working with the management team in helping to guide the Company's finance and operational activities." Additionally, PharmaFrontiers recently retained MDB Capital Group to serve as its financial advisor. MDB Capital Group is a research driven investment bank providing financial services The examples and perspective in this article or section may not represent a worldwide view of the subject. Please [ improve this article] or discuss the issue on the talk page. to emerging growth companies, as well as institutional asset management firms This is a list of corporations that provide financial asset management.
Mr. Boveroux added, "I am also pleased regarding our new relationship with MDB Capital, which will be important in helping us to access the capital markets and secure the funds we need to advance our research efforts and bring our therapeutics to patients." Financial Results The Company's financial statements compare the three and nine months ended September 30, 2005 with results from the three and nine months ended September 30, 2004 and with results from its inception through to September 30, 2005. The Company reported no revenue for the three and nine months ended September 30, 2005 or in its comparative period. General and administrative expenses during the three and nine months ended September 30, 2005 were $2,762,826 and $7,092,615, respectively, compared with $622,311 and $1,685,714 during the same periods in 2004. This increase is due primarily to the start-up of operations, which included the hiring of new personnel including employees and directors and scientific advisory board members. The increase is also attributable to the acquisition of Opexa Pharmaceuticals and the assumption of its operations. Also included are professional fees incurred from legal, accounting, and consulting services. Research and development expense was $626,720 and $1,877,787 for the three and nine months of 2005, respectively, compared with no expenses for the same periods in 2004. The increase is primarily related to the acquisition of Opexa Pharmaceuticals and the assumption of its operations and research and development programs, including its ongoing Phase I/II Clinical Trial for Tovaxin as well as the beginning of the Pre-Clinical Studies for 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 . Also included are professional fees incurred from consulting services and legal fees to secure and expand license patent claims. Interest expense was $1,385,234 and $7,323,573, respectively, for the three and nine months ended September 30, 2005, compared with $20,462 and $169,966 during the same periods in 2004. The increase is primarily related to the amortization of the remaining discount under the beneficial conversion feature of the 15% exchangeable convertible promissory Notes (the "Bridge 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 Bridge Notes that was converted into shares of Common Stock and offering costs associated with the bridge financing Bridge Financing A method of financing, used by companies before their IPO, to obtain necessary cash for the maintenance of operations. Notes: These funds are usually supplied by the investment bank underwriting the new issue. . PharmaFrontiers had a net loss for the three and nine months of 2005 of ($4,726,848) and ($16,221,894), or ($0.23) and ($1.16) per share (basic and diluted), compared with a net loss of ($628,250) and ($1,851,323) or ($0.08) and ($0.31) per share (basic and diluted), for the same periods in 2004. As of September 30, 2005, the Company had cash of approximately $4,353,000. In June 2005, PharmaFrontiers completed a private placement of approximately $5.08 million to accredited investors by issuing 3,387,217 units at a purchase price of $1.50 per unit; each unit identical to those issued in the Bridge Note exchange. On July 18, 2005, the Company completed a follow-on private placement of approximately $760,000 to accredited investors and issued 507,292 additional units at a purchase price of $1.50 per unit. About PharmaFrontiers Corp PharmaFrontiers is developing and commercializing cell therapies to treat several major disease areas led by Tovaxin to treat Multiple Sclerosis as well as cardiac and pancreatic 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 employed in treating MS. The Company also holds the exclusive worldwide license from the University of Chicago, through its 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 relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc 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 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, 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
September 30, 2005
(unaudited)
Current Assets
Cash $ 4,353,317
Prepaid expenses 169,955
------------
Total Current Assets 4,523,272
Intangible assets, net of accumulated amortization of
$1,479,609 26,539,721
Property & equipment, net of accumulated depreciation of
$259,110 344,710
------------
Total Assets $ 31,407,703
============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities
Accounts payable $ 521,232
Accrued expenses 254,823
Third party non-convertible note 1,500,000
------------
Total Current Liabilities 2,276,055
------------
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, 50,000,000 shares
authorized, 20,609,545 shares issued and outstanding 1,030,477
Additional paid in capital 49,069,732
Deficit accumulated during the development stage (20,968,561)
------------
Total Stockholders' Equity 29,131,648
------------
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 31,407,703
============
PHARMAFRONTIERS CORP
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF EXPENSES
Three and Nine Months Ended September 30, 2005 and 2004 and the
Period from January 22, 2003 (Inception) to September 30, 2005
(unaudited)
Inception
Three Months Nine Months Through
Ended September 30, Ended September 30, September 30,
2005 2004 2005 2004 2005
----------- --------- ----------- ----------- ------------
General &
admini-
strative $2,762,826 $612,145 $7,092,615 $1,685,714 $9,843,782
Research &
development 622,311 - 1,877,787 - 2,510,408
----------- --------- ----------- ----------- ------------
Net
operating
loss (3,385,137) (612,145) (8,970,402) (1,685,714) (12,354,190)
Interest
income 31,565 2,475 50,474 2,475 56,466
Other income 11,958 1,882 21,903 1,882 24,282
Interest
expense (1,385,234) (20,462) (7,323,573) (169,966) (8,237,701)
Loss on
disposition
of fixed
assets - - - - (457,122)
Other
expense - - (296) - (296)
----------- --------- ----------- ----------- ------------
Net Loss $(4,726,848)$(628,250)$(16,221,894)$(1,851,323)$(20,968,561)
=========== ========= =========== =========== ============
Basic and
diluted
loss per
share $(0.23) $(0.08) $(1.16) $(0.31) N/A
Weighted
average
common
Shares
outstanding 20,482,826 7,397,171 13,973,315 5,890,241 N/A
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