Yman,
Here is a blast from the past....so many things happen and now nothing....
Company Update - Feb. 9, 2012
Over the past year, major developments at NanoLogix have drawn the attention of food processors, medical and veterinary facilities, universities, major diagnostic kit producers, government agencies, large and small clinics and hospitals, and various labs. Interest in our products continues to grow among both domestic and international entities.
Our BNF (BioNanoFilter) technology was covered in a peer-reviewed publication in the November 2011 American Journal of Perinatology. Additional papers by independent third-party researchers covering testing results for Group B Streptococcus, Tuberculosis and six additional bacteria utilizing both BNF and BNP (BioNanoPore) technologies are currently in various stages of draft and submittal to major science and medical journals.
It is important to note that Nanologix has experienced notable product innovation during just the past two months. While executing testing and research activities, our partners have discovered extraordinary product performance improvements. The output from these third party efforts is leading to a series of changes with BNF diagnostic procedures. These developments are undergoing an intensive and accelerated battery of tests, the results of which remain confidential and sensitive and cannot be divulged until publication.
We have exhibited our BNF and BNP technologies at multiple events: the American Society for Microbiology (ASM) Biodefense and Emerging Diseases Meeting and the BPM-media Food Safety Summit, both in Washington, D.C., and at the ASM annual meeting in New Orleans. Two questions recur at these events: “Have peer reviewed third-party papers been published?” and “Do your products have FDA approval?” As of this year our answer is: “two papers” and: “We are working with an experienced third party on FDA applications.”
NanoLogix received notification in July from the BioStart business incubator in Cincinnati of the unexpected closing of the laboratory facilities we had occupied since 2006. This was a subsidized facility, with distinct economic advantages for all 18 client companies. After an unsuccessful search for a replacement facility in Cincinnati, NanoLogix saw this as an opportunity to relocate the lab operation to our Hubbard, Ohio headquarters, allowing us to centralize R&D with production and administration. Relocation of NanoLogix laboratory facilities began at the end of September. Full laboratory operations resumed in December with a new science staff and significant equipment upgrades. The move and establishment of a fully equipped laboratory was a major achievement for NanoLogix. In a very short time period, we accomplished the entire process, from hiring qualified new scientists to replacing the Cincinnati-based staff, through the purchasing of new equipment.
Financial Matters As of 1 February 2012, the company has 115,998,796 shares outstanding out of an authorized limit of 200,000,000 shares.
Our current monthly operations costs are approximately $60,000.00 That amount does not include the costs of FDA applications, NanoLogix-funded studies, other tests of our products by third parties, and new patent applications. At this point, NanoLogix is funded almost entirely by private placement stock sales, with approximately 25 qualified investors providing funding in exchange for common stock restricted from market sale for one year from date of issuance. To our knowledge, the majority of the private placement shares are retained by the investors after the one-year maturation. The company does not sell shares on the open market. That cannot be done without a new public stock offering and we foresee no justification for that to occur.
Global in vitro diagnostics is currently estimated to have an annual value of $44 billion USD. NanoLogix’s management is focused on positioning our BNP and BNF technology to enter and capture a significant portion of that market. We believe that businesses, and indeed whole industries, that need or supply diagnostics will choose our faster, simpler and cheaper technology over expensive, highly complex equipment that cannot differentiate between live active-threat and dead bacteria.
NanoLogix recognizes the threat our small company poses to suppliers of existing diagnostic technologies. As any company that has evolved from pure R&D to mass production can attest, the transition phase entails unique costs. NanoLogix has met those costs in preparing a manufacturing facility for production, building out a fully operational laboratory, and developing three different levels of diagnostic kits. In view of potential market impact for what could be the fastest active-threat diagnostic technology in the world, it would be strategically ill-advised to reveal our current financials at this time. The Board of Directors is in unanimous agreement on this strategy.
After consultation with Broadridge, a provider of shareholder meeting services for corporations, NanoLogix determined that the total cost of a shareholder meeting, either real or virtual online, lies in the range of $30,000. That is in consideration of the fact that the company now has over 3,000 shareholders. Practically all funds spent by the company have to be raised via private stock placement. With vision towards investing in crucial steps including patent filings, FDA approval applications, and testing recent discoveries, NanoLogix is delaying its virtual shareholder meeting until after our technology receives FDA approval and an increased revenue stream has been established.
We have been contacted by a number of companies domestically and internationally regarding business ventures and collaboration and are currently in talks with one Middle Eastern, two Turkish, and one Indian company interested in licensing, local production, and regional marketing.
NanoLogix has unilaterally cancelled a letter of appointment it had with Advanced Medical German Company, a Kuwaiti company. The Kuwaiti company had financial responsibility for a planned clinical study in Europe that did not happen.
Technology & Recent Developments Over the past three years, NanoLogix has benefited from extraordinary relationships with several institutions. These have led to exponentially reduced detection and identification times, plunging from days to hours to – very recently – minutes. This outreach and teamwork is leading to advances that will change the future of diagnostics. That is a huge claim. It is being borne out in tests at this moment.
NanoLogix’s BNF technology is currently being tested by the University of Texas Health Science Center (UTHSC) in Houston in a 300+ patient clinical study for detection and identification of Group B Streptococcus (GBS) in pregnancies. More than 280 patients in that study have been tested as of this date. Of significant note, this and other studies have resulted in improved protocol for use of our kits, which have now been protected with new patent applications/registrations. Prior to this study the standard lab culture time for GBS was 48-72 hours for detection and identification, plus additional time for determining antibiotic sensitivity. Initially, in 2010, tests using the BNF with GBS done in-house by NanoLogix provided results in about 15 hours, a remarkable reduction in detection and identification time. When NanoLogix teamed with the UTHSC-Houston to refine the test protocol, results began coming in at 4-6 hours. These results included detection, identification AND determination of antibiotic sensitivity. The importance of the results cannot be overstated, as the health of mother and baby depend on the most rapid determination of the presence of infection prior to birth.
In a stunning development that began in December, in studies by a yet-to-be-named third party, results have been attained for GBS, Anthrax, and other bacteria in one hour or less using the BNF.
Tuberculosis (TB)
TB has grown into a modern plague of almost Biblical scale, infecting an astounding one-third of the planet’s population, and killing 1.5 to 2 million people annually. NanoLogix has recently joined the World Health Organization’s StopTB Alliance in the effort to fight this threat.
Using NanoLogix BNP technology, researchers at an independent third-party R&D facility have recently attained results for TB live active-threat-bacteria detection within 4 days. Standard times for culturing live active-threat tuberculosis generally run into weeks.
Developments in the past several weeks indicate possible BNF test results for detection and identification of live active-threat bacteria TB within hours. This would contribute a major new weapon in the fight to eliminate TB. Not only is it vastly faster than other culture-based technology, it also promises diagnostics far cheaper and field-worthy than other technology…and with the ability to discern between live active-threat and dead bacteria, a vital identification which other technologies do not provide.
Food Safety
As it continues to explore other fields with market value, NanoLogix is developing its BNF product for early screening of a specific strain of Listeria. We are in the process of refining antibodies that should provide the ability to specifically differentiate the targeted strain from any others. This work is being done for a major food processing company in the United States.
Water Safety
In 2010, NanoLogix entered into a C ooperative Research and Development Agreement (CRADA) with the United States Environmental Protection Agency. One of the main microorganisms selected for detection is Cryptosporidium, an amoeba that caused the worst outbreak of waterborne illness in US history in Milwaukee in 1993. Recently NanoLogix achieved test results for Cryptosporidium with BNF technology in 3 hours. Standard detection and identification time is 14+ days.
New Patents Granted and New Filings In 2011 NanoLogix was granted patents for its BNC technology in the United States and China.
In 2011 the company filed a patent for a novel vacuum packaging for its petri dish kits called the “flat pack.”
In 2012 the company filed a unique application for the use of Aptamers with NanoLogix detection and identification technologies. According to our patent firm, this is the first known application for the use of aptamers in bacterial diagnostics.
Collaboration and Partners The management team at NanoLogix views the company’s relationships and collaborations as vital links to research, development, and professional communities. Over the past three years, in good faith, the company has volunteered to announce or refer to arrangements, agreements and associations with two companies, a university hospital, and one US agency. Each of those entities has been contacted via email and telephone by persons identifying themselves as NanoLogix shareholders and requesting the equivalent of insider information concerning our business arrangements and technology results. NanoLogix has confidentiality agreements in place with each of these entities. The scientists and physicians who received these contacts consider them unethical behavior. If not for NanoLogix’s strong professional relationships with these researchers the company could have incurred significant damage. With regret, NanoLogix will no longer elaborate on business relationships until they enter advanced stages.
This is the most exhaustive operations detail furnished at any time by the company. We trust that for those who understand the unique position NanoLogix occupies with potentially world-changing diagnostics technologies, this update is informative and helpful.
Bret T. Barnhizer, Chairman of the Board, CEO
Daniel D. Barnhizer, Esq. Director
John Chatterton, Director
Jeffrey Long, Director
