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OVANOME
Ovanome is a genetic test for predicting an ovarian cancer patient’s response to first-regimen Taxol¹ and carboplatin (TC) chemotherapy. 30% of chemo-naive women do not respond to TC treatment and DNAPrint™ research shows that this problem is largely a function of genetic polymorphism. Women who do not respond to their first regimen do not survive as long as those who do and they are unnecessarily subjected to the pain and difficulty of an ineffective chemotherapy. As an adjunct for the oncologist decision-making process, Ovanome could help improve the standard of first-regimen care for ovarian cancer patients.
DNAPrint™ genomics enters into sample collection agreement with bay area oncology group.
1-Taxol is a registered trademark of the Bristol-Myers Squibb company.
Xeleri/Xelox
Through collaboration with the Moffitt Cancer Research Center in Tampa, FL, we are investigating the genetic basis of Xeleri/Xelox response for colon cancer patients. Xeleri/Xelox is a chemotherapy that prevents the cell division that tumors need to grow but for some patients, normal doses do not elicit the desired effect. A genetic test for predicting Xeleri/Xelox response could help minimize the likelihood of colon cancer relapse.
Melphalan/Topotecan
Through collaboration with the Moffitt Cancer Research Center in Tampa, FL, we are investigating the genetic basis of Melphalan/Topotecan (MT) response in multiple myeloma patients. MT is a chemotherapy that prevents the cell division that tumors need to grow but for some patients, normal doses do not elicit the desired effect. A genetic test for predicting MT response could help minimize the likelihood of multiple myeloma relapse.
Ondansetron
Through collaboration with the Moffitt Cancer Research Center in Tampa, FL, we are investigating the genetic basis of Ondansetron response. Ondansetron is an anti-emetic for the alleviation of post-operative nausea and vomiting (PONV), but normal doses of the drug do not elicit the desired effect in some patients. A genetic test for predicting Ondansetron response could help reduce extreme discomfort many patients feel after surgery.
“Moffitt scientists and physicians were impressed with DNAPrint’s ADMIXMAP approach for using a populations’ structure as a fuel for mapping drug response gene variants. We recognized its profound potential for contributing to the enhancement of cancer treatment”, said Moffitt’s Dr. Timothy Yeatman.
Dr. Tony Frudakis, the scientific leader of DNAPrint and founder says, ‘By virtue of its broad scope and scale, and given its clinical setting, this is by far the most exciting research and product development opportunity yet for our young company. Our goal is simple - to present the FDA with what we can do and to pave the way for our brand of personalized medicine as the gold standard for drug development and use.’ He added, ‘The signing of this deal illustrates Dr. Gomez’s regulatory experience and leadership in the clinical development and pharmaceutical product approval process. This is invaluable to us as a company, as he brings a real world experience to our development programs.’
The M2GEN project will involve collecting thousands of tumor tissues and clinical data from patients from across the state, which will be analyzed to identify genetic markers specific to that tumor. Through this study, Moffitt and Merck (NYSE: MRK) officials say they can identify drugs that will give physicians the knowledge they need to individualize treatment for patients with a specific type of cancer, known as personalized medicine.
and
...Both Gomez and DNAPrint Genomics will also be part of a massive research initiative announced last month by the H. Lee Moffitt Cancer Center & Research Institute of Tampa. The center said it would partner with an affiliate of Merck & Co., Inc. pharmaceutical company to expand biotechnology research with the goal of developing personalized medicine.
Merck and Moffitt will form a for-profit company, called M2GEN, that will develop personalized cancer treatments using a patient's genetic profile.
Moffitt, Merck announce new cancer treatment plan
Tampa Bay Business Journal - December 18, 2006by Michael Hinman
Print this Article Email this Article Reprints RSS Feeds Most Viewed Most Emailed
In a move expected to bring more higher-paying biotechnology jobs to the Tampa Bay area, H. Lee Moffitt Cancer Center & Research Institute announced a partnership Monday with Merck & Co. to expand efforts to develop personalized medicine in treating cancer. The partnership had been several months in development.
It will create 170 jobs over a three- to five-year period with an average salary of $80,000, said William Dalton, chief executive officer for Moffitt.
"This deal will put Florida on the map in a way that makes the area one of the top sectors of economic development in the world," Gov. Jeb Bush said.
Funding for the project will come from the following sources: $15 million from the state of Florida, $20 million from Hillsborough County, $500,000 from the city of Tampa and "a very substantial amount" from Merck.
The M2GEN project will involve collecting thousands of tumor tissues and clinical data from patients from across the state, which will be analyzed to identify genetic markers specific to that tumor. Through this study, Moffitt and Merck (NYSE: MRK) officials say they can identify drugs that will give physicians the knowledge they need to individualize treatment for patients with a specific type of cancer, known as personalized medicine.
"This provides a human connection as well," Bush said. "There are people that are desperately seeking experimental treatments. This will create the capacity to discover and customize drugs to care for people in our state."
A company will be formed and located in Hillsborough County near the Moffitt campus at the University of South Florida Fowler Avenue site using incentives from the state, county and Tampa. Although no site was announced, it is believed to be near the current Moffitt location.
DR.FRUD
I AM HERE LONG BEFOUR YOUR ALIAS WOS BORN & KNOW YOUR HISTORY.
I INVESTED ON DNAPRINT (2000 PINK SHEETS) BECAUSE OF INTELECTUAL PROPERTY. SHORTLY IT MOVED FROM 0.04 TO 0.48. THET‘S 1200% GAIN. I MAID 600% PROFIT.
I REINVESTED 30% OF EARNED MONY IN THE BEGINNING OF 2003 BECAUSE OF ANSESTRY TESTS & DNAWITNESS. … IT MOVED FROM 0.017 TO 0.185 CENT- THET’S 1100% GAIN. I MAID 700% PROFIT.
NOW - FARMASEUTICALS & DIAGNOSTICS. .. REINVESTED 25% OF EARNED MONY & HAVE 1.200000 @ 0.0122.
PLANING TO SALL AT 1200% GAIN …
DR FRUT THINK POSITIVELY AND GOOD THINGS WILL HAPPEN TO YOU TO…
• Lipitor and Zocor combine for a market of almost $10billion annually [Campbell Alliance.com, July 19, 2004]. Lipitor has US sales of $5.8 billion per year and Zocor about $4.2billion [Institute for Integrative Nutrition “The Drugging of America” and Forbes Magazine, November 29,2004]
• A smaller market drug, Bayer’s Baycol was recently (2001) pulled from the market due to muscle-pain (myalgia), and myopathic (rhabdomyolysis) side effects, at which point from its introduction in 1997 over 6 million patients had taken the drug. Since then, 3,500 lawsuits have been filed and 2,825 claims settled for a total of $1.08 billion (Parker & Waichman Attorneys and Counselors at Law; “Injury Alert” November, 2004.
• Annual cost per patient for Lipitor and Zocor is $1,100 [Institute for Integrative Nutrition “The Drugging of America” and Forbes Magazine, November 29,2004]
• There are therefore approximately 9 million Lipitor/Zocor customers per year.
• About 2% (180,000) of Lipitor/Zocor patients experience myalgia side effect [Australian Government Department of Health and Ageing, Therapeutic Goods Administration “Australian Adverse Drug Reactions Bulletin 23(1) Feb 2004]
• This amounts to $198million per annum in wasted drug purchases, not to mention the human cost of muscle damage and illness. This averages out to $22 per patient in wasted charges.
• Assume a $100 test price for Statnome, 5 times the average wasted cost per patient, the premium justified by the protection provided against myalgia and potentially lethal rhabdomyolysis.
• With 10% market penetration (900,000 sales per year), this results in a Statnome market size of $90million.
Lipitor (atorvastatin and Related) - Rxboard
Re: DNAPrint genomics, Inc.
Posted By: Larry
Date: Monday, 13 August 2001, at 5:48 a.m.
In Response To: DNAPrint genomics, Inc. (Larry)
"The physician of the future will use our genetic solutions in order to classify a patient as a potential responder, non-responder,or somebody who is not compatible with the drug. A drug like Lipitor or Pravachol, when you get prescribed that drug to help you with your cholesterol level, you typically have to go back and have your blood taken from one or two applications of the drug, from the time you take the drug, and they look to see if there is evidence of liver damage. That's the only way that they can tell the drug is hurting you is to let it hurt you and then tell you later that its hurting you. The whole goal of DNA Print is going to be to eliminate that type of ridiculous risk that people are subjected to. To not prescribe medications to people based on population averages but to each individuals genetic profile to help applications of drugs. The physician of the future is going to have to rely on the research and development of companies such as ours, to be able to do that. They're going to access the solutions that we produce with our equipment and from our brains, from our mathematical ideas, from our applications of math to the data.
A solution for a problem might involve ten or more environmental variables or other physical characteristics of people that aren't ostensibly related to the trait. What they will be is complex. Each patient that is going to be screened for compatibility with the drug, will have to have their genetic profile taken. That profile will have to be compared against the solution for that drug. That solution determined by companies like us. The solution that describes how people in our population respond to drugs based on their genetic profiles. These are going to be very complex solutions. Accessing of the data is going to be accomplished through the internet most likely. First of all the hospital is going to need to know where to genotype a patient, where to look in their chromosome. We will tell them from our results. Our software will be a sort of an operating system. They want to produce a test for Provacol for patients, we'll look up Provacol and see what markers they need to screen. They'll order the test kits from one of our partners, commercialization partners. They'll perform the test at their hospital and they'll have raw genetic data from the patient. Which they won't know what to do with. What they're going to do with it is use our operating system to push it through the internet, compare it against our population level solutions, and to basically classify the patient based on our results".
Dr. Tony Frudakis
CEO/CSO DNAPrint Genomics
12/2/00
PARASITES AND BACTERIAS PLAYING MAJOR ROLE FOR THE EVALUATION.
WE NEED STOCKHOLDERS FOR VALUME @ ACCUMULATION
refreshing memory
http://www.twst.com/pdf/ABN618.pdf
Assumptions in the discounted free cash flow model
• The capital expenditure will increase 15% in 2005 and 2006, and then it will increase at a higher rate of 35% during 2007-2009 because a lot of their products are expected to be commercialized.
• DNAPrint does not attract the interests of VC, therefore, the management decided to raise more money by selling more of their common shares in the secondary market. We expected the shares outstanding to increase 8-10% every 2 years from 2005 to 2010.
• We assume the cost of capital to be 26% in the ultra high growth period, 22% for the normal high growth period, and 11% or the steady growth period. We believe these discount rates are conservative despite of DNAG’s low beta of 0.55, They should include the company’s individual risk into the analysis.
• We utilized Gordon Growth Model for the terminal value calculation, assuming a steady growth rate of 5% annually,
• The intrinsic value of DNAG”s share should be between $0.6&-$0.7 according to our Discounted Free Cash Flow model.
STATINOME. is being developed by DNAPrint genomics to address the need for more accurate determination of individual patient response to statins. Statins, such as LipitorTM, are a major class of drugs that inhibit the production of cholesterol and its level in the bloodstream. Medical researchers have long determined that patients with high levels of cholesterol or lipid metabolism dysfunction have a significantly higher risk of getting heart diseases. Statins are now routinely prescribed to reduce the risk of cardiac problems of these above mentioned patients. Studies have shown that a 10.3% decline in heart disease deaths between 1990 and 1994 alone was attributable to the use of statins. However, despite the broad use of statins, there is a significant risk to certain patients. Between two and five percent of patients experience adverse liver toxicities and some may also experience acute renal failure or serious muscle pain. Because of this relatively high rate of intolerance and the acute nature of these adverse reactions, physicians are forced to monitor liver enzymes and function prior to and during the first 12 weeks of treatment or during a treatment dose escalation phase of almost every patient, adding to the overall cost of treatment. While statins are serving a prominent life-saving role, it is clear that use of these drugs may be limited in cases where an adverse reaction might occur and extra cost per patient is incurred by needing to test for liver toxicities even in patients who may not have any adverse reaction whatsoever. DNAPrint genomics STATINOME may become an important tool in pre-screening and classifying patients as to their response profile. The Company has completed the
xenobiotic genomic screen for the product and is currently in process of validating the performance of the resultant classifier. The Company expects STATINOME to hit the market in 2007.
• Lipitor and Zocor combine for a market of almost $10billion annually [Campbell Alliance.com, July 19, 2004]. Lipitor has US sales of $5.8 billion per year and Zocor about $4.2billion [Institute for Integrative Nutrition “The Drugging of America” and Forbes Magazine, November 29,2004]
• A smaller market drug, Bayer’s Baycol was recently (2001) pulled from the market due to muscle-pain (myalgia), and myopathic (rhabdomyolysis) side effects, at which point from its introduction in 1997 over 6 million patients had taken the drug. Since then, 3,500 lawsuits have been filed and 2,825 claims settled for a total of $1.08 billion (Parker & Waichman Attorneys and Counselors at Law; “Injury Alert” November, 2004.
• Annual cost per patient for Lipitor and Zocor is $1,100 [Institute for Integrative Nutrition “The Drugging of America” and Forbes Magazine, November 29,2004]
• There are therefore approximately 9 million Lipitor/Zocor customers per year.
• About 2% (180,000) of Lipitor/Zocor patients experience myalgia side effect [Australian Government Department of Health and Ageing, Therapeutic Goods Administration “Australian Adverse Drug Reactions Bulletin 23(1) Feb 2004]
• This amounts to $198million per annum in wasted drug purchases, not to mention the human cost of muscle damage and illness. This averages out to $22 per patient in wasted charges.
• Assume a $100 test price for Statnome, 5 times the average wasted cost per patient, the premium justified by the protection provided against myalgia and potentially lethal rhabdomyolysis.
• With 10% market penetration (900,000 sales per year), this results in a Statnome market size of $90million.
PONV diagnostic
• DNAPrint’s PONV diagnostic test refers to the prediction of response to Ondansetron used as an anti-emetic to control postoperative nausea and vomiting in patients undergoing surgical procedures
• According to the National Cancer Institute over 500,000 Americans received chemotherapy in 2004, and the majority of these patients received an antiemetic such as ondansetron to prevent nausea and vomiting.
(Ondansetron) is the world's best-selling anti-emetic agent, generating annual US sales worth approximately $1.0 billion in 2003.
• Assuming a $500 price for PONV diagnostic (equivalent roughly to the average cost waste per customer) and 10% market penetration (50,000 sales per year) this results in a PONV diagnostic market of $25 million.
§
This report is intended for US residents and for information purposes only and should not be considered as advice or solicitation to buy or sell any Security.
0.1 next stop
http://www.amalfiresearch.com/report/DNAG.pdf.
Dec 18, 2006
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www.AmalfiResearch.comDNAG’s Diabetes-CD59 product is highly effec-tive in determining a patients “pre-diabet-ic” state. The product has extremely high potential in a massive multi-billion dollar market due to its ability to assist doctors and patients in preventing and avoiding diabetes. DNAG’s PT-401 EPO Dimer product, designed to treat Anemia, will enable DNAG to compete with industry giants Johnson and Johnson and Amgen in an $11 Billion market. DNAG’s product provides a signifi-cant advantage over competitors, it requires less injections, in smaller dosages, less often. Through the establishment of research partnerships and agreements with prestigious groups such as: Harvard University, Mass College of Pharmacy and Health Sciences, DNAG is able to test its products and compile data for future FDA approval procedures.DNAGis dedicated to the study of personalized medication and the development of prod-ucts that empower both the patient and the doctor by maximiz-ing drug efficacy and minimizing side effects. DNAGis well positioned for growth due to the ability of its proven, cost-effective technol-ogy to speed up the drug development process while reducing toxic side effect of future treatments.Investment Highlights GenomicsThe study of an organism’s genome and the use of the genes. It deals with the systematic use of genome information, associated with other data, to provide answers in biology, medicine, and industry.Genomics has the potential of offering new therapeutic methods for treatment of some diseases, as well as new diagnostic methods. Fore example, for women newly diagnosed with breast cancer, a genomic test called Onco-type DX assesses a patient’s individual risk of breast cancer recurrence and likely benefit from chemotherapy, which can help doctors make more informed and more personalized treatment decisions. Other applications are in the food and agriculture sectors.The major tools and methods related to genom-ics are bioinformics, genetic analysis, measure-ment of gene expression, and determination of gene function.Source: Wikimedia Foundation, IncClinical Trials without PharmacogeneticsClinical Trials with Pharmacogenetics
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www.AmalfiResearch.comHeadquar-tered in Sarasota Florida, DNA-Print Genom-ics (OTC BB: DNAG) is a leader in the field of genomic-based technolo-gies. From its in-ception, DNAG’s vision has always been to become a leading player in the global pharmaceutical industry. DNAG is a compilation of closely man-aged companies constructed by management in effort to:Maximize shareholder value through the acquisition and development of complementary business segments that exhibit potential to have an immediate positive impact on the bottom line. Recent acquisitions of Trace Genetics, Kenna Technologies Inc., and Ellipsis Biotheraputic and investment of Biofrontera AG exhibit management’s dedication to mini-mizing equity dilution and should prove extremely positive for investors in the near term.Enable the future growth of the DNAPrint Pharmaceuticals subsidiary through the validation of proprietary technologies in both the consumer and pharmaceutical industries. DNAGhas established a strong level of credibility and notoriety for its human genotyping tech-nology products which have had their success (more than 45,000 validated tests) well-documented by such highly esteemed media outlets such as ABC News, CBS News, US News and World Report, USA today, and the New York Times.Companies within the DNAG portfolio currently consist of: AncestrybyDNA, DNA print genomics forensic, Euro DNA, Trace genetics, Ellipsis biotheraputics corporation, DNA print genomics geneology, Kenna Technol-ogies Inc. DNAG also owns 18.3% interest in German pharmaceutical player Biofronterra AG.DNAGis dedicated to the science of pharmacogenomics, defined by the U.S. Department of Biotechnology Mistry of Science & Technology as “the use of genetic analysis in the drug develop-ment process to understand the interaction 1.2.between a given drug therapy and an individual ge-netic makeup; by using this informa-tion it is possible to design individ-ual based drugs to reduce side effects and avoid adverse drug reaction”. DNAG’s 4 Core Markets: Consumer DNA Products Market - The company’s Ances-tryByDNA product line has tapped into the firmly established market in the US for recreational consumer genealogical and ancestral research. AncestryByDNA is an affordable and effec-tive tool that allows the user to utilize genomics to more deeply explore their genetic heritage through submitting a DNA sample and receiving a detailed analysis of their BioGeographical ori-gins, sometimes going back as far as thousands of years. Forensics DNA Testing Market - DNAPrint™ is a leader in the field of presumptive testing. The company’s DNAWitness line of products and services is continuously evolving to aid detectives in the testing of DNA to create a physical description from crime scene DNA. Products in this segment provide an effective means of describing “persons of interest” by determining the genetic background of the suspectPharmacogenomics Market - The testing of individuals to predict their genetic predisposition to drug response is known as pharmacogenomics. Pharmacogenomics enables physicians to tailor drug therapies (formulation and dosage) for individuals based on their genetic composition, increasing rates of ther-apeutic success and decreasing rates of adverse side effects. DNAPrint™ is currently at the forefront of individualized medication and medication response forecasting technology, an area ex-pected to bring significant future value to the company and its shareholders. Contract Service Outsourcing Market-DNAPrint™ provides universities and drug discovery companies with genotyp-ing services. The service provides clients with the ability to screen efficiently and ef-fectively for genes that may be responsible for certain human traits and/or disease states.CORPORATE SNAPSHOTwww.AmalfiResearch.com
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www.AmalfiResearch.comManagement is ready to take things to the next levelThe company has stated on many occasions its dedication to acquiring the additional funding necessary to fund its DNAPrint Pharmaceutical subsidiary, currently a private equity company, which is 100% internally owned. In effort to both maximize shareholder value and build for the future, DNAG has recently acquired Ellipsis Biotheraputics, Inc., a 100% owned Canadian equity group and has also acquired an 18.3% stake in Biofronterra AG, a private German biopharmaceutical player. Empowering the Patient and the Doctor, Eliminat-ing Worldwide SufferingAccording to the U.S. Institute of Medicine, nearly 1.5 million Americans are injured each year due to medication errors. The promise of eliminating all toxic side effects of drugs is of major concern to the entire world. More importantly for DNAG and the United States as a whole, the U.S. FDA is extremely interested in pharmacogenomics and its potential to improve the less than stellar state of the country’s healthcare system. The F.D.A., which ultimately has the final say in the pharmaceutical industry, has issued a final guidance for acceptance of pharmacogenomic data that encourages the de-velopment of related products. U.S. FDA: A Key Growth Driver:As mentioned above, the U.S. FDA has strongly encouraged the development of theranostic and pharmogenomic products. This has attracted a significant amount of attention amongst the bio-tech and pharmaceutical industries. In addition to improving healthcare for the country, FDA support is expected to lead to a never seen before convergence of the diagnostic, pharmaceutical, and biotech indus-tries. The future is bright with the prospect of the best of the best joining together to embark on a new age of medical treatment and DNAG has a leg up on the competition. Technology is Fully Validated: Main Risks are As-sociated with Funding:As mentioned previously, DNAG’s technology has been validated on many platforms and the company’s success has been extremely well-documented by mainstream media. At this point in time, management feels that the main risk associated with the company’s success lies in its ability to secure essential funding going forward. In order to become Corporate HighlightsValued at more than $28 billion, the global diagnostic market represents strong potential for DNAG
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www.AmalfiResearch.coma key player in the pharmaceutical industry DNAGwill have to attract the attention of either a leading drug manufacturer or a few large institutional inves-tors. A Narrow Market Extends: Although by nature, DNAG diagnostics nar-row the market by identifying only positive responders. The market is also widened in the sense that it opens the door to finding a vi-able alternative to the non-responders. In the future, DNAG’s ability to internally develop theranostic products capable of predicting a patient’s response to specific treatments and suggesting the optimal medi-cal procedure to employ would likely result in signifi-cant financial gains for the company. DNAG is targeting sales of its diagnostic product currently in development to facilitate near term growth. Valued at more than $28 billion, the global diagnostic market represents strong potential for DNAG. Expertise in geneology expected to pay dividends in clinical development stageGenetic pre-determination is regarded by many as a potential key to unlocking clues about human pre-disposition to medication. This is being targeted as a potential means by which to revo-lutionize the clinical trial stage of drug development. DNAG has validated the effectiveness of its genetic testing technology on many platforms which acts as a major competitive differentiator. As many ap-plicants continue to struggle in regards to perfecting the process of determining the genetic background of a sample, DNAG is well-positioned to capitalize on their difficulties.Agreements such as those established with Emory Center for Medical Genomics are expected to facilitate the proliferation of DNAG’s technology into the clinical stage of U.S. drug development. DNAG is confident that its DNA tests will “establish a world standard for theranos-tic testing and help alleviate the suffering of cancer patients worldwide” Improving technology and gaining notoriety through research partnershipsThrough the establishment of research partner-ships and agreements with and prestigious groups such as: Harvard University, Mass College of Pharmacy and Health Sciences DNAG is expected to be able to accomplish a number of key achievements such as:Determining the pharmacological properties and perfecting the capabilities of internally developed drugs such as DNAG’s PT-401 product that tar-gets the $10 billion Erythropoietin market.1.Success Rates by StagesNCE’s5-10,000screenedPreclinicalTesting250 enterClinical Testing5 enterFDA1 Approves15->$800 Million
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www.AmalfiResearch.comConducting drug trials that will apply DNAG’s genetic ancestry data and proprietary technology to the clinical stage of drug development. Strict focus is placed on improving treatment and also generating and compiling data to be used in future filings with governing bodies such as the U.S. FDA.Gaining notoriety and building creditability in the pharmaceutical industry for its proprietary technology – that, by the company’s definition “ utilizes a proprietary technology measuring varia-tions among patient populations that relate to the patient’s response to particular drugs”Enormous potential in the anesthesia marketDNAG’s PONV (Post Operative Nausea and Vomiting) diagnostic test is able to determine how a patient is likely to react to anesthesia. This is very important to the anesthesiologist commu-nity and is expected to improve correct administration of anesthesia within the healthcare industry in coming years. DNAG is actively participating in the market for cancer treatmentDNAG is active in the cancer treatment mar-ket. Through a recently developed partner-ship with Neocodex, a Spanish biomedical and genomic research group, DNAG will test DNA samples to research the effectiveness of treatments for ovarian cancer (CaO) such as Taxotere, Taxol, Carbo-platin, and Cisplatin. The American Cancer Society predicts that in 2006, 20,180 new cases of CaO will be diagnosed in the United States and 15,310 women will die from the disease.Historically, the medical community has experienced significant difficulty both in identifying the disease in its early stages and in developing effective treatments. The use of bio-markers to diagnose the presence of ovarian cancer and also improve and speed drug development in this space has attracted widespread attention in recent years and DNAG is on the cutting edge of technology development. 2.3.The company’s OVANOME™ genomic-based diagnostic tool is currently in the development stage and is designed to eliminate the trial and error method of ovarian cancer treatment that often exposes patients to a variety of potentially harmful medications. By analyzing the relationship between human genes and medication response, DNAG hopes to make significant advancements over the current methods of diagnoses that often rely on population averages and do not focus on the unique genetic makeup or ancestral background of the patient.Under the recent agreement with Neocodex, DNAG will analyze DNA samples and drug response data provided by its partner and apply its proprietary Admixture Mapping (ADMIX) process to determine key Ancestry Informative Mark-ers (or AIM’s)and identify specific genes that may be related to patient drug response. Both parties are op-timistic of what the future holds for this partnership. Exemplifying this point, “Enrique Vazquez, President and CEO of NeoCodex added, “We are excited by the potential that our unique sample set brings to DNAP-rint’s platform. We believe the combination of highly-annotated, longitudinally collected samples coupled with DNAPrint’s ADMIX process will accelerate theranostic research and bring us one step closer to true personalized medicine.”“A company called DNAPrint genomics made headlines by telling law-enforcement officials in Louisiana that they’d been looking for a serial killer of the wrong race. Eyewitnesses had offered dif-ferent accounts of the race of the suspect — some thought he was black, others white -- and authorities had focused their search on white males between the ages of 25 and 35 based in part on an F.B.I. psycho-logical profile. But based on crime-scene specimens, DNAPrint said the murderer was probably black . . . When a black male was apprehended, his DNA was found to match that at one of the crime scenes. He was convicted of second-degree murder in August...”New York Times, 2004
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www.AmalfiResearch.comIt currently costs an estimated $800 million to bring a prescription medication into the FDA ap-proval stage. Far less than 5% out of every 5,000-10,000 new drugs in the primary new chemical entity (NCE) stage of drug development receive approval and experts are predicting that soon costs associated with FDA approval will balloon to $2 billion. To make things worse for developers, a high percentage of drugs receiving FDA approval never recoup costs associated with conducting the clinical trial stage over their entire life spans. DNAG Print Genomics is well-positioned to make a solid impact on the pharmaceuti-cal industry. Through its deep expertise in the marking of single nucleotide polymorphisms (“SNPs”) and use of computational biology DNAG is able to simulate clinical trials of medication with great accuracy. SNP’s are a variation in human DNA that can be used to predict genetic background. When combined with an effective computational model, clinical trials become much less expensive and time consuming, in addition to sparing the negative and non responder population. DNAG’s ability to provide ‘theranostic’ medication/diagnostic products capable of optimally matching patients with medicinal compounds that heal their specific ailments while reducing toxic side effects is expected to attract an increasing amount of attention from strategic partners and institutional investors. By many accounts, the majority of FDA ap-proved drugs have a real-response rate on average of around 60% with a high percentage closer 10-20%. Assuming that these facts hold true, even to some extent, DNAG has the potential to lead a breakthrough in the pharmaceutical industry. And this is not just a thought for the future, theranostic products are on the market to-day. Genetech was first to market with its biomarker for Herceptin, a breast cancer treatment effective in 25% of the population at best. In the future, DNAG plans to develop a growing family of “theranostic’ pharmaceutical products that decipher ‘positive’ from ‘negative’ responders and will poten-tially eliminate all toxic side effects of pharmaceuti-cal medications. In the near term DNAG will strictly focus on developing predictive drug response tests for a number of commonly used drug therapies. As the world shifts away from the largely inef-fective “one size fits all” method of medica-tion and towards personalized medication, DNAG will be able to assist an expanded popula-tion of drug developers that would not be capable of bringing a product to market without an effective diagnostic/pharmaceutical combination. A key benefit of the company’s technology is its ability to eliminate testing on the negative responder base that can be excluded from clinical trials through effective genetic pre-testing. DNAG’s proven expertise in the development of technologies capable of characterizing patients with a high level of accuracy and ability to provide a product that maximizes the ef-ficacy and minimizes side effects of new medications are extremely positive indicators for its future. In addition to supporting products of other companies, DNAG has also recently licensed its first lead drug candidate PT-401 EPO dimer product. This product is expected to compete with industry giants Johnson and Amgen as it provides the patient with an effective treatment that requires lower doses, less frequently.Key Applications
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www.AmalfiResearch.comPotentially harmful prescription drugs, future disease outbreaks, and the need for personalized medicine. The Food and Drug Administration (FDA) has issued a variety of public health advisory warn-ings regarding prescription medications such as Vioxx, Celebrex, and Bextra as it discovered evidence of increased risk of heart attack and stroke associated with their use. As the U.S. public becomes increasingly wary of the potentially harmful side effects associ-ated with the use of many prescription drugs, the push for personalized medicine is gaining strength. DNAG plans to leverage its expertise in genomics-based technology into the development of new prod-ucts that predict with great accuracy how specific hu-man populations react to various medical treatments, thereby reducing the instances of product recalls and toxic side effects. The company will be extremely well poised for growth in the future if through internal devel-opment and strategic partnerships; DNAG is able to develop ‘theranostic’ products capable of pre-determining a patient’s response to a particular therapy and selecting the most effective treatment out of all available selections. Some notable commentary regarding the harmfulness of various prescription medications include: A study led by a Food and Drug Administration safety official projects that the widespread use of Vioxx may have led to more than 27,000 heart at-tacks and sudden cardiac deaths before the drug’s abrupt withdrawal (Wall Street Journal). A recent study conducted by the Mayo Clinic found that Rheumatoid arthritis patients being pre-scribed Humira and Remicade face three times the risk of developing of cancers such as lymphoma, skin, gastrointestinal, breast and lung tumors, and double the risk of contracting serious infections. ••A report in The New York Times quoted Uni-versity of Pennsylvania cardiologist Dr. Garrett FitzGerald as stating that people taking Bextra have more than twice the risk of heart attacks and strokes compared with people who took place-bos. He based his comments on pooling data from 5,930 patients participating in 12 clinical trials. FitzGerald says Bextra “is a time bomb waiting to go off.” The European Medicines Agency (EMEA) and its Scientific Committee for human medicines found that patients treated with valdecoxib (Bextra) showed a higher rate of serious cardiovascular thromboembolic events (e.g. myocardial infarc-tion, cerebrovascular accident) compared to the group of patients receiving placebo. Personalized medicine is not just a thought for the future. Bayer Diagnostics predicts that the theranostics market will grow by 20% per year until 2010. Furthermore, at this point in time a growing number of medications are being prescribed only after a DNA test is conducted to ensure that no genetic pre-disposition to negative patient response exists. In addition, experts have linked human genomics to suscep-tibility and resistance to pandemic diseases such as SARS and HIV. This is an ••Key Considerations
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www.AmalfiResearch.comSingle nucleotide polymorphismsor SNPs (pronounced “snips”) are DNA sequence varia-tions that occur when a single nucleotide (A,T,C,or G) in the genome sequence is altered. For example a SNPmight change the DNA sequence AAGGCTAA to ATGGCTAA.Although more than 99% of human DNA sequences are the same across the population, variations in DNA sequence can have a major impact on how humans respond to disease; environmental insults such as bacteria, viruses, toxins, and chemicals; and drugs and other therapies. This makes SNPs of great value for biomedical research and for developing pharmaceutical products or medical diagnostics. SNPs are also evolu-tionarily stable --not changing much from generation to generation --making them easier to follow in popula-tion studies. Scientists believe SNP maps will help them identify the multiple genes associated with such complex dis-eases as cancer, diabetes, vascular disease, and some forms of mental illness. These associations are difficult to establish with conventional gene-hunting methods because a single altered gene may make only a small contribution to the disease. Source: genomics.energy.govextremely positive indicator of the potential widespread use of DNAG’s patented tech-nologies.A sampling of instances that exhibit the corre-lation between genomics and human response to medication uncovered in recent article by Hsien Hsien Lei, PhD include:The UGT1A1 gene variant predisposes people to a decrease in white blood cells if they are prescribed Camptosar, a Pfizer drug for colon cancer. A lower starting dose should be set for the 10 percent of people who carry this gene variant.The TPMT gene is associated with slow me-tabolism of 6-mercaptopurine, or 6MP, a drug for childhood leukemia and inflammatory bowel diseases. In people who carry two cop-ies of the TPMT gene variant, 6MP can also cause a deadly decrease in white blood cells. High levels of the Her2 protein in breast can-cer tumors indicate treatment with Herceptin. Specific HIV mutations induce resistance to particular drugs. Genes for the cytochrome P450 enzyme fam-ily are involved in drug metabolism. The 2D6 enzyme metabolizes codeine into morphine. Fast metabolizers can overdose on relatively small doses of codeine while slow metabolizers would gain little relief from pain. A Roche DNA chip can detect variations in genes for 2D6 and 2C19. Ten percent of Caucasians have a variation of 2D6 that makes it difficult for them to elimi-nate the antidepressants Prozac and Paxil; alternative treatment uses Celexa or Lexapro because they are metabolized by 2C19. The 2C9 and vitamin K epoxide reductase en-zymes are involved in determining a person’s sensitivity to warfarin, a drug for the preven-tion of blood clots.www.AmalfiResearch.comA Single nucleotide polymorphism, or SNP, is a tiny variation in an individual’s genetic code. SNPs occur when a single nucleotide (A,T,C, or G) in the DNA sequence in a region of the genome is changed.
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www.AmalfiResearch.com(CONCluSIONANDINVESTMENTTHESIS)Taking into consideration DNAG’s1Rapidly improving financial situation that is exemplified by the company’s genera-tion of $1.9 million in revenues during first 9 months of 2006, a 110% increase in com-parison to the first 9 months of 2005;2Current product pipeline that is expected to facilitate entry into some of the worlds’ hottest pharmaceutical/healthcare markets, currently cumulatively valued at more than $12 billion;3Fully-validated technology, that has been embraced by highly-esteemed federal agencies such as the U.S. FBI and the UK’s Scotland Yards and also widely chronicled by such prestigious news outlets as ABC News and the New York Times;4Increasing traction in the North American and European media and the use of its EuroDNA(TM) product as the basis of the UK television show “100% British”;5Investment in Biofronterra A.G. which con-tinues to gain value; and6Unique position as a global leader in a new era of medication and valuable experience in the development of theranostic products;At today’s price of 0.0095, we feel that DNAP-rint Genomics Inc. represents a relatively low-cost inroad into a wide variety of healthcare related markets with the potential to provide exponential growth in the not so distant future.DisclaimerAmalfi Research Group Research reports are published by Amalfi Research Group, Ltd. “Amalfi Research”. Amalfi Research is neither a registered investment advisor nor a registered broker/dealer. Readers are advised that this publication is issued solely for information purposes and should not be construed as an offer to sell or the solicitation of an offer to buy any security. Amalfi Research’s report does not purport to be a complete analysis of every material fact respecting any company, industry or security. Although the opinions and statements included herein are based on sources believed to be reliable and in good faith, no representation or warranty, express or implied, is made as to their accuracy, completeness or correctness.We encourage readers to consult with independent financial advisors with respect to any investment in the securities mentioned herein. Any opinions, projections and predictions expressed in this research note are statements of judgment as of the date of publication, are subject to change without fur-ther notice, and may not necessarily be updated or reprinted in future publications or elsewhere. Opinions, projections and predictions contained herein are those of the author(s), and are not an assurance or guarantee of actual results. Neither Amalfi Research, nor its members, managers, officers, employees, or consultants accept any liability whatsoever for any direct or consequential loss arising from any use of this newsletter or its contents. An Affiliate of Amalfi Research has been compensated twelve thousand dollars in cash and expects to receive 2,750,000 rule 144 restricted shares of stock by DNAPrint Genomics, Inc. (OTCBB: DNAG) for profile coverage. See Disclaimer on website.Amalfi Research and its members, managers, writers and employees have not accepted compensation from any other of the companies discussed in this report. From time to time, Amalfi Research allows public issuers or third parties acting on their behalf to redistribute content published by Amalfi Research relating to that issuer. Under these circumstances, the issuer or third party may spend a significant amount of money to redistribute an Amalfi Research Group report on the company. Amalfi Research and its members may from time to time establish positions in the securities of the companies discussed in within Amalfi Research reports. Copyright © 2006 Amalfi Research Group, Ltd. All rights reserved
DNAGhas the potential to revolutionize the pharma-ceutical industry through the development of products designed to speed the pharmaceuti-cal drug development process, reduce costs associated bringing medication to the FDA approval stage, and eliminate toxic side effects of future medications.The company continues to exhibit its dedication to maximizing shareholder value through the execution of key strategic acquisitions and solid rev-enue growth. DNAG’s 1st Qtr 2006 revenue increased 280% over Q1 2005 and 2005 annual revenues grew 160% over 2004 marking 4 straight years of increased revenues.DNAG’s $1.8 million dollar investment in Biofronterra could po-tentially increase to $15,000,000! Over 4 cents per share! Coverage by ABC News, CBS News, US News and World Report, USA today, and the New York Times has highlighted the validation of DNAG’s technology and its ability to pre-determine the genealogical back-ground of patients. DNAGboasts more than 45,000 validated geneological tests and has documented in excess of 500 solved cases for high profile agencies such as the U.S. FBI and the UK’s Scotland yards in addition to helping authorities catch the Louisiana Killer and other high profile crimi-nals.
DNAPrint Genomics, Inc. presents at the NYSSA 10th Annual Biotech/Specialty Pharma Industry Conference
Tue, Dec 12, 2006, 1:40 pm Eastern
Listen to the archived event audio
http://biz.yahoo.com/cc/5/75735.html
DNAPrint Genomics offers pharmacogenomics that permit personalized drug development with fewer patients, shorter duration, and lower costs.
10th Annual
Biotech/Specialty Pharma Conference
DATE December 12–13, 2006
TIME Day One 8:30 a.m.–5:10 p.m.
Day Two 8:30 a.m.–4:30 p.m.
CHAIRS Sherry Lombardi, The Answer Factory
Laurie Malen, The Answer Factory
LOCATION NYSSA
1177 Avenue of the Americas, 2nd Floor
(between 45th and 46th Streets), NYC (Directions)
Photo ID required for access to the building.
REGISTER/FEE Early Registration by November 28
One Day: Members $195 | Nonmembers $295
Two Days: Members $295 | Nonmembers $395
Registration November 29 to December 5
One Day: Members $265 | Nonmembers $365
Two Days: Members $365 | Nonmembers $465
After December 5
Register at the door: Additional $50 due (space permitting)
CONFERENCE
DESCRIPTION 2005 was a relatively strong year for the biotech and specialty pharmaceuticals industry. Global revenues were over $80 billion, compared with $22 billion in 2000. The industry’s market cap closed the year at an all-time high of $488 billion. The IPO market has opened up: Seventeen companies raised $819 million in the U.S. in 2005, with slightly over half currently trading above their IPO price.
Small-cap biotech stocks took a downward turn during the first half of 2006, but have been on an incline since August, regaining most of their losses. The Amex Biotechnology Index is up by almost 10% as of early November, and the Nasdaq Biotechnology Index is now flat for the year. Can investors expect a sustained rally before the end of 2006 and into 2007?
Don’t miss this chance to learn about the current and future opportunities in specialty pharmaceutical and biotechnology stocks. The CEOs, CFOs, and other VIPs from many of the industry’s most innovative small- and micro-cap companies will discuss their plans to develop and market important new drugs, diagnostics, and delivery technologies.
AGENDA Day 1
8:30 Check-in & Continental Breakfast
8:55 Welcome & Opening Remarks
9:00 Overview of the Biotech Industry
George Fulop, MD, MS
Vice President, Biotechnology and Life Sciences Equity Research, Needham & Company
9:30 CytRx Corporation (Nasdaq: CYTR)
Jack Barber, PhD, SVP, Drug Development
Steven A. Kriegsman, President and CEO
Matthew Natalizio, CFO
CytRx, a biopharmaceutical research and development company, is engaged in the development of high-value human therapeutics.
10:10 Break
10:20 DURECT Corporation (Nasdaq: DRRX)
Schond L. Greenway, Vice President, IR and Strategic Planning
An emerging specialty pharmaceutical company, DURECT is focused on the development of pharmaceutical systems based on its proprietary drug delivery platform technologies.
11:00 DRAXIS Health Inc. (Nasdaq: DRAX; TSX: DAX)
Mark Oleksiw, CFO
DRAXIS Health is a rapidly growing specialty pharmaceutical provider of contract manufacturing services for international clients and radiopharmaceuticals for its own account.
11:40 BioSante Pharmaceuticals, Inc. (AMEX: BPA)
Stephen M. Simes, President and CEO
BioSante Pharmaceuticals is developing a pipeline of hormone therapy products to treat both men and women.
12:30 Luncheon Presentation: The Emerging Field of Stem Cells
Michael D. West, PhD, President and Chief Scientific Officer, Advanced Cell Technology; Author of The Immortal Cell: One Scientist's Quest to Solve the Mystery of Human Aging
1:00 Heska Corporation (Nasdaq: HSKA)
Robert Grieve, PhD, Chairman and CEO
Heska sells advanced veterinary diagnostic and other specialty veterinary products.
1:40 DNAPrint Genomics, Inc. (OTCBB: DNAG)
Hector J. Gomez, MD, PhD, Chairman and Chief Medical Officer
DNAPrint Genomics offers pharmacogenomics that permit personalized drug development with fewer patients, shorter duration, and lower costs.
2:20 Viral Genetics, Inc. (OTCBB: VRAL)
Michael Capizzano, VP, Finance, Business, and Corporate Development
A biotech company, Viral Genetics is discovering and developing immune-based therapies for HIV/AIDS and infectious and autoimmune diseases.
3:00 Break
3:10 Xechem International, Inc. (OTCBB: XKEM)
Ramesh C. Pandey, PhD, Chairman and CEO
Xechem International, a biopharmaceutical company, is engaged in developing drugs for sickle cell disease, malaria, AIDS, and cancer from natural sources.
3:50 Aradigm Corporation (Nasdaq: ARDM)
Igor Gonda, PhD, President and CEO
Aradigm is using its advanced AERx pulmonary platform and novel formulations to develop novel respiratory products.
4:30 The Immune Response Corporation (OTCBB: IMNR)
Joseph F. O’Neill, MD, MPH, President and CEO
The Immune Response Corporation is an immuno-pharmaceutical company focused on developing products to treat autoimmune and infectious diseases.
5:10 Closing Remarks & Adjournment
AGENDA Day 2
8:30 Check-in & Continental Breakfast
8:55 Welcome & Opening Remarks
9:00 Outlook for Small- and Micro-Cap Biotechs
Matthew G. Cohen, MD, VP, JP Morgan Investment Management
9:30 Cyclacel Pharmaceuticals, Inc. (Nasdaq: CYCC)
Spiro Rombotis, President and CEO
Cyclacel Pharmaceuticals is dedicated to the discovery, development, and commercialization of novel, mechanism-targeted drugs to treat human cancers and other disorders.
10:10 Break
10:20 Neuro-Hitech Pharmaceuticals, Inc. (OTCBB: NHPI)
Reuben Seltzer, CEO
A biopharmaceutical company, Neuro-Hitech Pharmaceuticals is focused on the development and commercialization of next-generation compounds against proven targets for neurodegenerative diseases.
11:00 The Quigley Corporation (Nasdaq: QGLY)
Guy Quigley, Chairman, President, and CEO
Albert Piechotta, Director of Marketing and Communications
Michael Petteruti, Director of Technology Resources
The Quigley Corporation is a diversified natural health medical science company.
11:40 Provectus Pharmaceuticals, Inc. (OTCBB: PVCT)
Craig Dees, PhD, CEO
Provectus Pharmaceuticals is a pioneering pharmaceutical company actively engaged in the design, development, and marketing of pharmaceutical technologies for the treatment of breast cancer, liver cancer, and metastatic melanoma.
12:20 Lunch
1:00 EntreMed, Inc. (Nasdaq: ENMD)
James S. Burns, President and CEO
EntreMed, a clinical-stage pharmaceutical company, is developing next-generation multi-mechanism oncology and anti-inflammatory drugs.
1:40 Advanced Cell Technology, Inc. (OTCBB: ACTC)
William M. Caldwell, IV, CEO
Advanced Cell Technology is a biotechnology company applying human embryonic stem cell technology in the emerging field of regenerative medicine.
2:20 Cleveland BioLabs, Inc. (Nasdaq: CBLI)
Michael Fonstein, PhD, CEO and President
A drug discovery company, CBLI is developing technology from the Cleveland Clinic that modulates apoptosis.
3:00 Break
3:10 XTL Biopharmaceuticals Ltd. (Nasdaq: XTLB)
Ron Bentsur, CEO
XTL is focused on the development of novel drugs for infectious disease.
3:50 Neuralstem, Inc. (OTCBB: NSTM)
Richard Garr, President and CEO
Neuralstem intends to treat patients with its patented human neural stem cell technology.
4:30 Closing Remarks & Adjournment
NYSSA reserves the right to change any part of its published program or list of
presenters due to unforeseen circumstances.
any idea how many shears holds the board
i have 1.2mil
50000 dna test...good number=7-8million???
http://www.npr.org/templates/story/story.php?storyId=5438960
Copies of the report can be obtained by emailing rripatti@khandaker.com.
Khandaker Partners Initiates Research on DNAPrint genomics, Inc.
Monday November 21, 2005 7:00 am ET
SARASOTA, FL--(MARKET WIRE)--Nov 21, 2005 -- DNAPrint(TM) genomics, Inc. (OTC BB:DNAG.OB - News), a developer of genomics-based products and services, today announced that Khandaker Partners, an independent research and advisory firm specializing in small cap and emerging growth companies, has prepared a research report on the Company and its technology.
Included in the report is a comprehensive interview with Hector J. Gomez, M.D., Ph.D., Chairman and Chief Medical Officer, and Richard Gabriel, President and Chief Executive Officer, who lay out their vision for the DNAPrint genomics' future.
The report, which was paid for by the Company, can be accessed online at www.dnaprint.com or at http://www.khandaker.com/index.cfm?page=viewcompany&CoID=879#analyst_report .
Copies of the report can be obtained by emailing rripatti@khandaker.com.
About DNAPrint
DNAPrint genomics, Inc. (www.dnaprint.com), through its DNAPrint Pharmaceutics, Inc., wholly owned subsidiary, is a developer of genomics-based products and services focused on drug development, computational biology and pharmacogenomic diagnostic tests. Computational biology and pharmacogenomics services are also offered externally to biopharmaceutical companies. The Company's first theranostic product (drug/test combination) is PT-401, a "Super EPO" (erythropoietin) dimer protein drug for treatment of anemia in renal dialysis patients (end stage renal disease). Currently in pre-clinical development, PT-401 will be targeted to patients with a genetic profile indicating their propensity to have the best clinical response. DNAPrint also develops and markets products for the law enforcement forensics and consumer markets that include DNAWITNESS(TM), RETINOME(TM), ANCESTRYbyDNA(TM) and EURO-DNA(TM).
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Forward-Looking Statements
All statements in this press release that are not historical are forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including, but not limited to, uncertainties relating to technologies, product development, manufacturing, market acceptance, cost and pricing of DNAPrint's products, dependence on collaborations and partners, regulatory approvals, competition, intellectual property of others, and patent protection and litigation. DNAPrint genomics, Inc. expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in DNAPrint's expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based.
DNAG ECONOMIC VALUE $44.95 MILLION
Assumptions in the Economic value added model • The company’s effective tax rate for DNAPrint should be 35% due to the tax loss carry forward from previous fiscal years, and then it returns to a normal tax rate level 0f 39%. • The company will still be expanding in the next decade; therefore, we believe the company won’t pay out any kinds of dividends in next 10 years. All net incomes will be translated into retained earning. • The Market value of the company is estimated to be between $40m to $50m according to our EVA model. Economic Value Added ($millions) 2005 2006 20072008200920102011201220132014 2015 2016 EBIT -5.6 -7.1 3.713.124.351.874.585.095.5100.0 99.5 97.4NOPAT = EBIT * (1 - tax rate) -3.6 -4.6 2.28.014.831.645.451.858.361.0 60.7 59.4 Capital 2.2 -1.5 -6.1-3.84.118.750.094.7145.2201.9 261 319.3 WACC Ultra high growth: 26% Normal high growth: 22% steady growth: 11% Cost of Capital 0.6 -0.4 -1.6-1.01.14.911.020.816.022.2 28.7 35.1 EVA -4.2 -4.2 3.89.013.826.734.431.042.338.8 32.0 24.3 Discounted EVA -3.3 -2.7 1.93.64.36.78.66.37.15.3 3.6 2.2 Market Value $44.95 M
© Khandaker Partners. All rights reserved. The information and data contained herein is not warranted or represented to be accurate and complete.
This report is intended for US residents and for information purposes only and should not be considered as advice or solicitation to buy or sell any Security.
Product pipeline: Diagnostic products
PRODUCT INDICATION STATUS PMA MARKET
OVANOME§ OvarianCancer Ph II 2Q06 2006 PONV§ nausea/vomiting Ph II 4Q06 2007 STATINOME§ Statins Diagnostic Ph II 2Q07 2008 MELPHALAN Myeloma Diagnostic Ph I 1Q08 2009 ACENOME§ Ace Inhibitors Ph I 2Q08 2009 BC-LOH§ Breast Cancer Ph I 3Q08 2009 XELOXI§ Colorectal Cancer Ph I 4Q08 2009 Diabetes§ Diabetic Complicat.. Ph I 1Q09 2010
Price Target $0.64
November 4, 2005 DNAPrint Genomics, Inc. (OTCBB: DNAG) DNAPrint Genomics Inc. is a developer of genomics-based drugs, diagnostics, and forensics and consumer products. DNAG utilizes proprietary methods in the fields of genomics and pharmacogenomics to analyze genetic variations called single nucleotide polymorphisms (SNPs). SNPs are the part of the human DNA that imparts to each one of us our individuality. The Company is the only one to use a special type of SNP called an AIM (Ancestry Informative Markers), which give more power to identify the genes responsible for and predictive of commercially important traits, such as a person’s predisposition to respond to drugs (pharmaceutical market), certain physical characteristics (forensics market), and genetic ancestry (consumer market). DNAG has recently formed DNAPrint Pharmaceuticals, Inc., a wholly owned pharmaceutical subsidiary that will be responsible for the development of diagnostics and theranostic (test/drug combination) products. Organizational Chart (Source: DNAprint genomics, Inc.) DNAPrint genomics, Inc.DNAPrintPharmaceuticals, Inc.Forensics DivisionConsumer DivisionDiagnosticsTheranosticsDNAPrint genomics, Inc.DNAPrintPharmaceuticals, Inc.Forensics DivisionConsumer DivisionDiagnosticsTheranostics • Theranostic Products. PT-401, (erythropoietin dimer) is a theranostic (test/drug combination) product currently in pre-clinical development for treating anemia associated with a number of indications. PT-401 will be targeted to patients with compatible genetic profiles, ensuring an optimal clinical benefit. In case of approval, PT-401 could generate annual revenue as high as $300m. • In addition to PT-401, DNAG plans to initiate Ph II clinical trials with three other Theranostics products: PT-201 for ophthalmic allergies, PT-301 for nasal allergies and PT-301 for atopic dermatitis. • Diagnostic Products: Nine genomic-based predictive diagnostics test are in development. In essence, these are the Theranostics products minus the drugs, which are “owned” by other companies, leaving the diagnostics test as a stand-alone product. • OVANOME™ matches ovarian cancer patients with the most suitable form of chemotherapy. STATINOME™ determines whether patients will be favorable or adverse responders to statins, which are effective in cholesterol reduction. A third product, yet to be named, is in development for predicting the response to Ondansetron, a drug used to treat postoperative nausea and vomiting. Others are listed in Table1. • Forensic and Consumer Products: DNAG has developed and introduced to market other similar products for the fields of forensics and consumer genetics. ANCESTRYbyDNA™ and EURO-DNA™ permit customers, such as genealogists or even the curious lay-person to determine their genetic heritage. November 4, 2005 Initial coverage Jian Jin & Samir Qureshi MBA Khandaker Equity Research (212) 763-5580 research@khandaker.com www.khandaker.com Price 10/20/2005 $0.01 Price Target $0.64