For the six months ended 30 June 2006, Xechem International, Inc.'s revenues decreased 33% to $2K. Net loss decreased 8% to $4.5M. Revenues reflect decreased demand for the Company's goods and services. Lower loss reflects presence of other income vs. an expense, absence of share of net loss from affiliate, decreased salaries & wages cost, decreased consulting fees and decreased directors &officers insurance cost.
Posts: 889 | From: Corona, CA | Registered: Mar 2006
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quote:Originally posted by pepsiman: ANY BODY GOT AN IDEA AS TO WHY ITS TANKIN?
Buy the rumor, sell the news?
maybe if they switched strategy - file the 8k and then the PR.
Actually that wouldn't make much of a difference IMO. Waiting to see what else they have before the big meeting.
-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7800 | From: Virginia | Registered: May 2006
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posted
Kitty,I was woundering where you got your info. Reason I ask is because I just talked to Steve Berg investor relations for XKEM. His main point he made was they have had no revenue to speek of. so he questioned your numbers as well as the rest of your comments. He suggested we go to the 10K. By the way I'm not attacking you on this. I read your post, then called him up and asked about it, thats all. I'm just an investor trying to understand the stocks movements.
Posts: 78 | From: Spanaway | Registered: Apr 2006
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quote:Originally posted by pepsiman: Kitty,I was woundering where you got your info. Reason I ask is because I just talked to Steve Berg investor relations for XKEM. His main point he made was they have had no revenue to speek of. so he questioned your numbers as well as the rest of your comments. He suggested we go to the 10K. By the way I'm not attacking you on this. I read your post, then called him up and asked about it, thats all. I'm just an investor trying to understand the stocks movements.
you didnt ask him about the $9.38 million loan ?
Posts: 4112 | Registered: Jun 2006
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posted
Yes,I did. He mentioned they were still working on two other small ones. Said they have alot of good things going on. He didn't say any thing about the share increase and I fgorgot to ask. What were you referring too about the loan, dollar?
Posts: 78 | From: Spanaway | Registered: Apr 2006
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posted
PPS can be easy manipulated for MM , the reason i ask you about the loan ,is because this loan is a big news believe it or not it will accelerate the NIGERIA FACILITY in less time than it was expected.
posted
I understand. I was so depressed because the stock tanked. I could have sold it and bought it back almost where I bought it in the first place. On the loan thing, keep in mind they are in the monsoon season. nothing will be done for alittle bit. But when they can they will be at it hard.
Posts: 78 | From: Spanaway | Registered: Apr 2006
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posted
XKEM goes through money like it is going out of style..... So the loan will be used up shortly... Xkem will make gr8 money for holders but it will take a while... Im buying back at .02
posted
Wiat until after the share holders meeting we will hear some good things about the future and also find out the increase in the a/s and what it really means and how they will use it. This and other things will be coverd
Posts: 6008 | From: phoenix az | Registered: Mar 2005
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posted
do they have good food at these things or is it just a conference room full of people?
LOL
-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7800 | From: Virginia | Registered: May 2006
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posted
Xechem Announces ``Notice of Allowance'' for a Patent Relating to a Method of Treating Sickle Cell Disease With 5-HMF Compound Licensed from VCU Business Wire - October 23, 2006 7:00 AM (EDT)
NEW BRUNSWICK, N.J., Oct 23, 2006 (BUSINESS WIRE) -- Xechem International, Inc. (OTC BB: XKEM) announced today the United States Patent and Trademark Office has issued to Virginia Commonwealth University (VCU) a notice of patent allowance relating to a method of treating Sickle Cell Disease (SCD) with a unique 5-membered heterocyclic anti-sickling agent known as 5-HMF. A notice of allowance is a written notification that a patent application has cleared an internal review and is nearing issuance.
The exclusive, worldwide rights for the production, sales and marketing of 5-HMF for use in the battle against SCD belong to Xechem as part of a collaborative licensing agreement with VCU. In May 2006, Xechem was successful in obtaining Orphan Drug designation from the US Food and Drug Administration (FDA) for use of 5-HMF by patients afflicted with SCD.
Xechem also announced recently that it has received a SBIR grant in the amount of $473,181 from the National Institutes of Health, National Heart, Lung and Blood Institute (NIH-NHLBI) to carry out the toxicity studies on 5-HMF.
5-HMF is a Pure Compound
Research led by Donald Abraham, Ph.D., professor of medicinal chemistry, VCU School of Pharmacy, has shown that 5-HMF, a pure compound with very little, if any, toxicity, has a high affinity for sickle cell hemoglobin and may be effective in the treatment of SCD. "Our findings suggest that this anti-sickling agent may lead to new drug treatments and may one day help those suffering with SCD. This molecule, 5-HMF, is the most promising molecule to treat sickle cell anemia to come from our research group in more than 30 years," Abraham said.
With the addition of 5-HMF, Xechem has now been able to expand its potent arsenal for treating Sickle Cell Disease beyond its Natural Herbal Drug, NICOSAN(TM), which was approved on July 3rd, 2006, by Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC) and is currently being sold in Nigeria on a limited basis.
According to Xechem's Chairman and CEO, Dr. Ramesh C. Pandey, "With all of the excitement over the recent commercial launch in Nigeria of NICOSAN(TM), our all Natural Herbal Drug, there has been less attention focused on our other SCD product, 5-HMF, which also represents an extremely promising potential treatment for patients suffering with this terrible disease. As a pure compound, 5-HMF is the perfect complement to our herbal product and together with NICOSAN(TM) places us in a unique position of providing much needed efficacious treatment for this painful and debilitating condition. As the exclusive licensee for this product, we are very pleased to have the protections that a patent allowance affords to VCU and to us."
About Sickle Cell Disease
Sickle Cell Disease (SCD) is an inherited blood disorder caused by an abnormality in the hemoglobin molecule. Patients with the disease often produce stiff, abnormally shaped red blood cells that often do not flow freely through the blood vessels. This can create clogs in the vessels, which in turn can cut off the flow of normal hemoglobin and oxygen to parts of the body, and can cause severe painful attacks or "crises", damage to various organs and shortened life spans. People with SCD often suffer unpredictable painful crises several times a year lasting from a few hours to a week or more. In the US, there are approximately 80,000 patients with SCD. In Nigeria, that number is believed to be approximately 4 million, with an estimated 10 - 12 million sufferers throughout the African continent. Worldwide, at least 16 million individuals are believed to be afflicted with SCD.
About Xechem
Xechem International is a development stage biopharmaceutical company working on Sickle Cell Disease (SCD), antimalarials, and antiviral (including AIDS), anticancer, antifungal and antibacterial products from natural sources, including microbial and marine organisms. Its focus is on the development of phyto-pharmaceuticals (Natural Herbal Drugs) and other proprietary technologies, including those used in the treatment of orphan diseases. Xechem's mission is to bring relief to the millions of people who suffer from these diseases. Its recent focus and resources have been directed primarily toward the development and launch of NICOSAN(TM) (named HEMOXIN(TM) in the US and Europe) for the prophylactic management of Sickle Cell Disease (SCD). With the recent Nigerian regulatory approval of NICOSAN(TM), Xechem is now scaling-up the commercialization of the drug in Nigeria and making preparations for the pursuit of US FDA and European regulatory approval.
Forward Looking Statements
This press release contains certain forward looking statements within the meaning of Section 27A of the Securities Act of 1933 as amended, and section 21E of the Securities and Exchange Act of 1934, as amended, which are intended to be covered by safe harbors created hereby. Such forward looking statements involve known and unknown risks and uncertainties.
SOURCE: Xechem International, Inc.
Xechem International, Inc. Stephen Burg, Director, 707-425-8855
Posts: 339 | From: Canada | Registered: Dec 2005
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posted
Way back when....I did some reading on this 5-HMF. To me it seemed more promising than the NICOSAN. Nice to see that it is getting some attention now that NICOSAN is in production in Nigeria. We will see how the shareholders meeting goes tomorrow.
posted
Sally there is a plan at the end of 2 more years if all goes well you will see another factory complete fda approval in the US.More drugs to come out they are in the pipe line.
This not inside info this comes from about 9 months of talking to Steve Burg.
As of now in New Jersey a 35,000 sq. ft office and lab,in china an office I do not know the sq ft. and in Niger a 20,000 sq.ft. lab and small production abilities and they are breaking ground on there first major factory.
They are working on a treatment for aids now. The hype is over for a while but it won't be long until they get some major endorsements. I have put some shares away for the long haul
Posts: 6008 | From: phoenix az | Registered: Mar 2005
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posted
Bond, do you have more information about the AIDS treatment? Have you discussed this with Burg lately? Thanks in advance....
Posts: 291 | From: NJ | Registered: Jun 2006
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posted
no I have just read it in my dd and I asked burg and he said they were but knew nothing at what stage and research complete details was something he was not given 100% information on.
I had pages of dd I had posted on this stock and that was part of it they blew it out and kicked me out as a moderator so now I post I wish they would have left my weeks of dd here for thoes who were seeking info
Posts: 6008 | From: phoenix az | Registered: Mar 2005
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posted
Sally this is where I first heard of aids research it was in an old pr
September 02, 2003 09:00 AM US Eastern Timezone
Xechem's Sickle Cell Drug, NIPRISAN -HEMOXIN- Granted Orphan Drug Status by the FDA
NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--Sept. 2, 2003--Xechem International, Inc. (OTC BB: XKEM) announced today that it received Orphan Drug designation from the U.S. Food and Drug Administration (FDA), Office of Orphan Drug Products Development for NIPRISAN (HEMOXIN(TM)), the phyto-pharmaceutical drug for the treatment of patients suffering with Sickle Cell Disease (SCD). SCD is an insidious and painful genetic blood disorder often resulting in death at an early age. According to an article published in the British Journal of Haematology, in July 2002, an investigative study of NIPRISAN (HEMOXIN(TM)) has revealed this phyto-pharmaceutical compound has a strong anti-sickling effect.
Orphan Drug status entitles a company to various incentives including the waiver of Regulatory Filing fees, access to potential grant funding for non-clinical and clinical research to generate required data for marketing approval, and seven years of marketing exclusivity for a designated drug once approved by the FDA.
Xechem International, Inc. (the "Company") owns the exclusive rights to the NIPRISAN (HEMOXIN(TM)), a drug cocktail, which is a phyto-pharmaceutical composition of four traditional plants extracted in a proprietary process. The licensor of the technology is the National Institute for Pharmaceutical Research and Development (NIPRD) in Abuja, Nigeria. Nigeria has the highest sickle cell disease population in the world estimated at between four and six million sufferers, roughly three to five percent of the country's population. NIPRD has already conducted Phase I, Phase IIa and IIb clinical trials and is currently conducting Phase III clinical trials in Nigeria. The results of the Phase IIa and IIb trials while limited to a patient pool of 82 patients nonetheless resulted in a complete remission of SCD crisis in 73% of the patients taking the drug and a substantial reduction in crisis for the remaining patients in the study. The Nigerian human clinical trials were performed using a double-blind crossover study at six months using a placebo.
In the United States, there are approximately 80,000 patients suffering with SCD who have, on average, three to five crises per year. The estimated annual insurance costs for hospitalization associated with SCD crises is approximately $475 million.
According to Xechem's founder and President, Dr. Ramesh C. Pandey:
"We are pleased to hear this good news from the FDA. Receiving an Orphan Drug status for this phyto-pharmaceutical from the FDA's Office of Orphan Drug Products Development helps Xechem come a step closer to bringing its product to the patients who suffer from SCD. Having been granted Orphan Drug status for NIPRISAN (HEMOXIN(TM)) brings credibility to the value of phyto-pharmaceutical medicaments and also provides our investors with a better understanding of the Company's core competency. The granting of Orphan Drug status for NIPRISAN (HEMOXIN(TM)) marks a significant milestone in our Company's history."
Xechem International, Inc. is headquartered in New Brunswick, NJ, with subsidiary companies in the United States, India, and Nigeria with joint ventures located in the Peoples Republic of China, and Hong Kong. The Company is engaged in the research, development, and production of generic and proprietary drugs from natural sources, as well as specializing in the development of niche-generic, difficult to replicate anticancer (including generic Taxol(R)), antiviral (including HIV/AIDS) and antibiotic resistant bacterias such as Helicobacter Pylori (H. Pylori), Vancomycin resistant Enterococcus Faecalis (VREF), Methicillin resistant Staphylococcus Aureus (MRSA) and Candida Albicans. The Company's management and scientific team are also considered world wide as experts in the field of nutraceuticals and screening of extracts and pure compounds from various parts of the world for their therapeutic use.
Xechem Pharmaceuticals Nigeria Limited's current involvement with NIPRD and Sheda Science and Technology Complex (SHESTCO) through its operations in Nigeria will also give the Company a first hand view and potential collaboration in other important pharmaceutical developments in HIV/AIDS and Malaria currently being funded by the Nigerian government. Nigeria has the largest population of any country in Africa and one of the target focal points for the United Nations Development Program, Millenium Goals and other foundations such as USAID and the Bill and Melinda Gates Foundation. These groups are actively engaged in funding the research and development of new pharmaceuticals for the entire continent of Africa.
Contacts
Xechem International, Inc. Dr. Ramesh C. Pandey, 732-247-3300 or Dean Petkanas, 516-333-5522
Company Information Center Quote/Chart
Posts: 6008 | From: phoenix az | Registered: Mar 2005
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posted
today we should get a good idea how the future will shape up. And what we should do long or short term
Posts: 6008 | From: phoenix az | Registered: Mar 2005
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Posted by: nordica1 In reply to: pakman who wrote msg# 58917 Date:10/24/2006 11:41:40 AM Post #of 58955
OK, I'm here with Smartmoney. Meeting is going great. Great turnout, very impressive panel and guests.
BTW, not sure if this has already been PR'd, the drug has also got Orphan Drug Status in the European Union !!
Will update later !
ps - coffee is great and Pandey is a captivating speaker , definitely NOT a deer in headlights
Posts: 6008 | From: phoenix az | Registered: Mar 2005
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posted
Posted by: nordica1 In reply to: knowlesmsncom who wrote msg# 59011 Date:10/24/2006 12:45:17 PM Post #of 59044
Per Board re: Revenue Guidance:
" Market is too LARGE to accurately give revenue projections, just too many variables at this early stage of development. "
It appears that they are deliberately moving slow towards their pre-factory (full scale) quota in order to smooth out any distribution issues prior to full scale production
Posts: 6008 | From: phoenix az | Registered: Mar 2005
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posted
I am sure we'll see the .00x's or .01 very soon, once they start dumping shares into the mix Sad to see my vote for no new Shares lose. I know bond has said some good things about what they can do with the new money from these additional shares... but with the loan they just got, that would have been enough to work for a while, until they got the new building working at 100%.
Ohh well, this stock looked good, but now looks to be a long LONG holder, unless a merger comes soon.
Red
Posts: 723 | From: MotorCity | Registered: Jun 2006
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posted
3.5 billion a/s thats going to hurt the pps for a while and if the company does use them to dilute the pps will range and not go up. They say they are not going to use them but why would you create them then?
This going to be a long term play so I am going to figure out how I will play it glta
Posts: 6008 | From: phoenix az | Registered: Mar 2005
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Posted by: bigdaddyc25 In reply to: None Date:10/24/2006 11:26:12 PM Post #of 59342
Good job on the summaries boys. It was GREAT to meet those that were in attendance. We made contacts today that will be of most value in our continued DD.
Here is what I want to add:
1)Funding (Vitamin M - as Pandey called it) They need about $20M to bring full scale product to market in Nigeria, and begin clinical trials and FDA app in US - $9.3M already approved - $4 - $5M expected from NEXIM - ??? pre-purchase from the Nigerian govn't
The pre-purchase will be huge, and is close now. Company officals hinted at it all day, and kept telling us something was cooking, but could not yet give us the details. The Nigerian lady from the health ministry also hinted at it very strongly. I asked her clear cut, how could the Nigerian people afford the drug? She responded that the govn't was going to pay for it, and that she was told not to say anymore at this time.
2) Increase in AS Basically dilution is just about done at XKEM. They restricted the 1.5B shares because they know they do not need them. They asked for 5B prior to completion of the UPS loan, and responded quickly to our concerns. They have left the remainder of the increase in tact, as a back-up for remainning funding. They also mentioned the need for employee incentives, and possible acquisitions. I do not belive O/S will go over 2.5B, and that they are making EVERY efforty possible to eliminate dilution.
3) Demand in Nigeria The Nigerian Director of Schetsco, who was at the meeting, also surprised me, when he told us all that the Nigerian sufferers reported at approx 4M people, is grossly understated. He said that teh number is closer to 10M. He said that the only concern XKEM would have after the new factory is built, is how they are going to expand it. The Nigerian officials made it very clear that the drug works, and that the demand is huge right now.
4) US Market Pandey stated that funding from above will also cover the beginning of US clinical trials. He also said that he expects US ap[proval in approx 2 years. The part that surprised me was that he said orphan status drugs sell for as high as $50,000 a year per patient in the US. This could be a $4B drug in the US alone. WOW and 7 years of 100% exclusivity.
5) Europe
The head of XKEM Europe, announced that XKEM is now able to sell NICOSAN in Europe. He announced this as great news to the whole group, and then Pandey and the gang danced around the follow up questions. I found this very interesting.
6) Institutional Investors
I was sitting beside TRYZ on one side, and teh HEAD of a Hedge Fund on the other side. I got the guys card, and will call him to discuss things further. His fund owns approx 13M shares. He told me that institutions are starting to notice XKEM. He also told me that there is alomost no short position on XKEM right now, and that the decrease in share price, was due to weak longs, and Chassman. His group is very bullish on XKEM. He also knows a lot of things we don't. For example, he told me that Chassmna does not vote at any of the meetings.
More will come as I remember. I was very impressed with the passion and energy form Pandey. He is smart and relentless. I have no doubt he will succeed.
later BigD
Posts: 6008 | From: phoenix az | Registered: Mar 2005
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Sad to see my vote for no new Shares lose. I know bond has said some good things about what they can do with the new money from these additional shares... but with the loan they just got, that would have been enough to work for a while, until they got the new building working at 100%.
