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Biotech / Medical : Antex Biologics (ANTX) -- Ignore unavailable to you. Want to Upgrade?

To: F. Jay Abella, III who wrote (745)	3/5/1998 11:15:00 AM
From: John R Resseger	Respond to of 1476

F Jay How long do Phase 1 Trials generally take ? Seems like this should be due any day now. ANTEX BIOLOGICS TO BEGIN CLINICAL TRIAL ON HELICOBACTER VACCINE Gaithersburg, MD, November 15, 1996 - Antex Biologics (Nasdaq:ANTX) today announced that the U.S. Food and Drug Administration (FDA) approved the initiation of a clinical study under an Investigational New Drug (IND) Application for an orally administered Helicobacter pylori vaccine for the prevention of peptic ulcers, gastritis and other related disorders. This randomized double-blinded Phase I clinical trial will be composed of approximately 40 volunteers and will determine the safety and immunogenicity of the Company's vaccine. The vaccine consists of whole killed H. pylori cells in combination with a mucosal adjuvant. "In addition to testing for safety and immunogenicity, data obtained from this Phase I trial may confirm the H. pylori vaccine's efficacy as demonstrated by preclinical studies," said Dr. Vic Esposito, Chairman and CEO of Antex. "We are looking towards this trial to provide evidence that our vaccine will be useful as a prophylactic and potential therapeutic treatment of H. pylori disorders in humans." H. pylori is a common bacterial pathogen of humans worldwide. In developing countries, it is estimated that 100% of children 3 years or older are carriers of this pathogen. H. pylori is the major cause of chronic active gastritis and peptic ulcer disease and a risk factor for gastric cancer. Infection also increases the risk of other diseases including persistent diarrhea. "As there is no preventive treatment for H. pylori, this approval for a major clinical trial for an H. pylori vaccine is a significant achievement for the Company," said Dr. Esposito. "This vaccine, our third to enter clinical studies, demonstrates the continued progress of Antex's programs and further validates the power of the Company's core technologies in developing preventive treatment," said Dr. Esposito. John

To: F. Jay Abella, III who wrote (745)	3/6/1998 9:58:00 AM
From: John R Resseger	Read Replies (1) \| Respond to of 1476

Just published March 5th an Updated analysis Of Antex Biologics. Westergaard-Abella BioMedTech Online westergaard.com. The following is an excerpt from the above. Jay I have posed a question at the bottom. VALUATION (only for the human vaccines) 1.Campylobacter vaccine for diarrhea and gastroenteritis - Phase II 2.H Influenzae vaccine for otitis media, pneumonia, meningitis - Phase I 3.H pylori vaccine for gastritis, peptic ulcers, gastric carcinoma - Phase I 4.Shigella, Moraxella, Chlamydia, Pneumococcus and Neisseria vaccines are in nonclinical trials. Campylobacter - 2mm cases per year at a cost of $20 (assumed) = $40mm total US market. Penetration of 10% first year times 0.4 for Phase II trial = $1.6mm contribution to market capitalization. H. influenzae vaccine for otitis media. Assume $20 treatment for 5mm cases per year = $100mm total market. Multiply $100mm times 10% penetration times 0.3 for phase I trial = $3.0mm contribution to market cap. H. Pylori vaccine - assume 5mm new cases at $75 per treatment - market potential is $375mm per year (very conservative). Multiply by 0.3 for Phase I trial and 10% market penetration = $22.5mm contribution to market cap. Five nonclinical programs contributing $5mm toward market cap each = $25mm. Technology value = $52.1mm Patents on compounds in clinical trials = $1.5mm Plus current assets minus long term debt = $6.3mm TOTAL = $59.9mm Management Factor Accumulated Deficit = $12.06mm Revenues since inception = $7.86mm Factor = 7.86/12.06 = 0.65 (excellent by industry standards!!!) ADJUSTED MARKET CAPITALIZATION = [59.9*0.65] + 59.9 = $98.8mm Fully diluted shares outstanding = 29.188mm Share price = $3.38 Jay, I find it curious that the vaccines in preclinical testing get a $5M valuation each yet Campylobactor which is near the end of Phase 2 Human trials is valued at $3M