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Liking the sounds of an exclusive agreement with GTC and Nexia
Nexia receives GTC technology for Protexia development
2004-09-23 08:55 ET - News Release
Mr. Jeffrey Turner reports
GTC BIOTHERAPEUTICS GRANTS LICENSE TO TECHNOLOGY TO SUPPORT NEXIA BIOTECHNOLOGIES' PROTEXIA(R)
GTC Biotherapeutics, Inc. and Nexia Biotechnologies Inc. have signed an exclusive agreement for GTC to license its transgenic technology for Nexia to continue the development, manufacture and sale of Protexia. This licensing agreement includes access to GTC's beta casein promoter and an option to license its filtration technology, which has been demonstrated to have utility for initial purification of Protexia. Protexia is a recombinant form of butyrylcholinesterase (BChE) produced in the milk of Nexia's transgenic goats. BChE is a naturally occurring enzyme found in the circulatory system of humans and acts as a bioscavenger which may be used to prevent the toxic effects of nerve agents and other organophosphate compounds. Protexia is being developed by Nexia jointly with the U.S. Army Medical Research Material Command (USAMRMC) and with Defence R&D Canada Suffield (DRDC Suffield), for therapeutic and prophylactic applications. The financial terms of the licensing agreement were not disclosed.
"Protexia has the potential to be an important biodefence product," stated Geoffrey F. Cox, PhD, GTC's chairman of the board and chief executive officer. "We are pleased to be able to license our intellectual property for the development of Protexia."
"GTC's casein promoter and filtration technology are important and a proven component of Nexia's manufacturing process for Protexia," commented Jeffrey D. Turner, PhD, president and chief executive officer of Nexia. "The technology GTC and Nexia are putting together enables the development of this innovative biotech-based medicine to counter a significant chemical weapons threat globally and at home." Nexia is working with the USAMRMC under the broad agency announcement contract, and a co-operative research and development agreement. Research and testing of Protexia are also being developed under a three-year, financed development and testing agreement with DRDC Suffield. Nexia has reported that Protexia has delivered broad spectrum protection against multiple lethal doses of nerve agents in animal models. In addition, Nexia has reported that in animal models a single injection of Protexia delivers sustained elevation of BChE levels in the blood, where it neutralizes the deleterious toxic effects of nerve agents.
The Protexia program has begun the stages of herd scale-up, purification process development and preclinical studies to support the filing of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA).
About GTC
GTC Biotherapeutics is a leader in the development, production and commercialization of therapeutic proteins through transgenic animal technology. GTC's ATryn, a recombinant form of human anti-thrombin, is undergoing review for market authorization in Europe. Subject to satisfactory approval, GTC will be the first company to commercially offer a transgenically produced product, which is projected for mid-2005. In addition to the ATryn program, GTC is developing a recombinant human serum albumin, a malaria vaccine, and a CD137 antibody to solid tumours. In its external programs, GTC's technology is used to develop transgenic production of its partners' proprietary products, including both large-volume protein therapeutics as well as products that are difficult to produce in significant quantities from conventional recombinant production systems. GTC's external program collaborations are developing transgenic versions of products such as monoclonal antibodies and immunoglobulin fusion proteins for conditions such as rheumatoid arthritis, HIV/AIDS and cancer. One of the external programs is in clinical trials with a transgenically produced product. Additional information is available on the GTC website, http://www.gtc-bio.com.
WARNING: The company relies upon litigation protection for "forward-looking" statements.
Nice move. Here's why:
Nexia hits a nerve; government finances Protexia
2004-09-20 08:31 ET - News Release
Dr. Jeffrey Turner reports
CANADIAN GOVERNMENT EXPANDS SUPPORT TO BENEFIT NEXIA'S COUNTER-TERRORISM ANTIDOTE (PROTEXIA(R)) DEVELOPMENT IN A 3 YEAR PROGRAM
Nexia Biotechnologies Inc. and Defence R&D Canada -- Suffield, Alta. (DRDC Suffield), have signed a three-year agreement to accelerate the development of Protexia, a biotech antidote for the world's most dangerous chemical weapons (nerve agents).
Under the terms of the agreement, DRDC Suffield has allocated $2-million to execute on three objectives at its facility to delineate the clinical utility of Protexia against specific chemical weapons threats. The prophylaxis medical indication involves protecting military personnel or first responders during deployment in situations with chemical weapons threats. The postexposure therapy indication is for the use of Protexia to treat casualties of chemical weapons. The third objective explores antidote combination therapy to define the best combination of existing nerve agent antidotes with Protexia. Of particular interest is the expected positive synergy between Protexia and oxime antidotes. Nexia is contributing senior scientific and technical staff to DRDC Suffield and will produce the Protexia antidote in its Montreal facility.
"Our mission is to research promising new antidotes, test their performance within demanding military environments and then provide data that supports the regulatory approval process to allow product fielding that secures the Canadian Forces," commented Dr. Thomas Sawyer, principal investigator, DRDC Suffield. "Our results clearly show that Protexia is effective in countering the effects of nerve agents in animal models."
"DRDC's financial and technical support will accelerate the development of Protexia by carrying out essential preclinical studies designed to show that Protexia is safe and effective as a nerve agent antidote," commented Dr. Jeffrey Turner, president and chief executive officer, Nexia Biotechnologies. "The commitment of funds and the access to military chemical weapons testing facilities show the importance of this program."
Protexia is a recombinant version of human butyrylcholinesterase, a promising new antidote (medical countermeasure) that has been shown to protect animals from the toxic effects of multiple lethal exposures of the world's most dangerous chemical weapons -- nerve agents. Butyrylcholinesterase is a protein that is found naturally in blood to protect humans from naturally occurring toxins. Unfortunately, extraction of this important protein from blood, where it is present in minute quantities, is not feasible in commercial quantities. Protexia, Nexia's recombinant version of this protein, can neutralize a wide range of nerve agents, such as soman or VX, once they enter the bloodstream. Nexia produces Protexia through an advanced, proprietary transgenic process, and hopes to upgrade to clinical-grade Protexia by mid-2005. This biotechnological approach offers sufficient manufacturing power to make Protexia available for the protection of both military personnel and the civilian population.
"We are extremely pleased that DRDC Suffield has the opportunity to work with Nexia Biotechnologies in such a forward-looking technology, one that is core to our mandate," stated Dr. Angus, director general, DRDC Suffield.
About DRDC Suffield
DRDC Suffield is Canada's centre of expertise in chemical and biological defence. DRDC offers timely technical advice, seminars, training and equipment to counter hazards from the use of chemical or biological agents. Advances in biochemical detection and identification, decontamination, and medical countermeasure research continue to see DRDC Suffield as a world-class leader in CB research. DRDC Suffield is one of six defence research establishments of Defence R&D Canada (DRDC). DRDC, an agency within the Department of National Defence, has been keeping Canada in the forefront of defence and national security technology by providing scientific leadership to the Canadian Forces and the Canadian defence industry for more than 60 years. For more information, visit its website at www.drdc-rddc.gc.ca.
WARNING: The company relies upon litigation protection for "forward-looking" statements.
Just checking in.
I haven't owned this stock in a while. Anybody buy the dip today?
Nexia narrows Q1 2004 loss to $1.86-million
2004-01-28 09:00 ET - News Release
Mr. Jeffrey Turner reports
FIRST QUARTER 2004 FINANCIAL RESULTS REPORTED BY NEXIA
Nexia Biotechnologies has released its financial results for the first quarter of fiscal 2004, ending Nov. 30, 2003. The company has also received ratification of its 2004 slate of directors during its annual general meeting and made changes to management.
The company thanked outgoing members Marcel Thibault, Livio D. DeSimone and James McDonald for their many contributions to Nexia, and welcomed Peter Janson and Joseph Rus as new members to the board of directors. Mr. Janson was the former chairman and chief executive officer of AMEC (formerly Agra Inc.) from 1999 to 2002. He previously held the position of president and chief executive officer at ABB Inc. U.S.A. from 1996 to 1999. Mr. Rus is the president and chief executive officer of Shire BioChem and has occupied this position since his appointment in 2001, upon the merger of BioChem Pharma and Shire Pharmaceuticals, where he held the position of president.
At the management level, departures were James McDonald, who held the position of executive vice-president -- corporate development, Bradley Cilley, who was vice-president -- business development, medical devices and Taoufik Mabrouk, who was vice-president -- operations, proteins. Management welcomes Kenneth Johnson as acting chief operating officer. Mr. Johnson previously occupied the position of vice-president -- therapy systems for MDS Nordion from 1999 to 2004 and held the rank chief operating officer of Fisher Scientific Worldwide division for many years prior.
On Nov. 20, 2003, Nexia reported in Stockwatch that the United States Army Medical Research Institute of Chemical Defense (USAMRICD) presented results from its Protexia program at the joint services scientific conference on chemical and biological defence in Towson, Md. These results indicated that Protexia, manufactured in transgenic goats, would bind a broad spectrum of nerve agents and had properties very similar to human butyrylcholinesterase (HuBChE) when compared in vitro under identical conditions. The data also indicated that Protexia was capable of binding stoichiometrically with nerve agents on a one-molecule-to-one-molecule basis.
Furthermore, on Jan. 22, 2004, Nexia announced in Stockwatch positive results from the Protexia in vivo efficacy studies conducted by the USAMRICD. The U.S. Army's demonstration of Protexia's in vivo efficacy was an important independent assessment. Protexia clearly protected all the animals in the study. These positive in vivo efficacy results with recombinant BChE are consistent with the army's research experience with plasma-derived BChE.
Financial overview
For the quarter ending Nov. 30, 2003, Nexia reported, in line with expectations, that the net loss deceased $790,000 to $1.86-million, or eight cents per share, when compared with a loss of $2.65-million (12 cents per share) for the quarter ending Nov. 30, 2002. The decrease was due to reductions in almost all spending categories and increases in contract revenue from the U.S. Army of $253,000. A non-recurring closure charge of $120,000 relating its Plattsburgh facility was incurred.
Contract revenues for this quarter increased to $253,000 from nil for the quarter ended Nov. 30, 2002. The revenues relate to the research contract with the U.S. Army to develop Protexia. Interest revenues for the quarter ended Nov. 30, 2003, decreased by $47,000 to $109,000 from $156,000 for the quarter ended Nov. 30, 2002. The decrease in interest revenues was primarily due to lower cash balances.
Gross research and development expenses, including amortization expense of $240,000 ($257,000 in 2002), for the quarter ended Nov. 30, 2003, decreased by $590,000 to $1.51-million from $2.10-million for the quarter ended Nov. 30, 2002.
Investment tax credits and other government assistance (ITC) in this quarter decreased by $32,000 to $188,000 from $220,000 for the quarter ended Nov. 30, 2002. Investment tax credit receivables decreased by $70,000, due to reduction in research and development salary expenses. During the current quarter, the company recorded grants of $38,000 from the Canadian Department of National Defence.
Business development expenses for the quarter ended Nov. 30, 2003, decreased by $105,000 to $361,000 from $466,000 for the quarter ended Nov. 30, 2002, which was primarily due to lower salary expense.
Administrative expenses decreased by $50,000 to $351,000 for this quarter from $401,000 for the quarter ended Nov. 30, 2002, which was due to a reduction in salary expense. The overall decrease in administrative spending during the quarter was offset by a foreign exchange loss of $18,000, which occurred due to a large decrease in the U.S. dollar exchange rate. On Oct. 28, 2003, the company decided to close its facility in Plattsburgh, N.Y., and recorded a non-recurring charge of $120,000 for closure costs.
Nexia had cash and cash equivalents of $15.4-million at the first quarter. The major uses of funds during the three-month period ended Nov. 30, 2003, included $1.5-million used for operations, and $56,000 invested in property, plant, equipment and intellectual property, compared with $2.7-million and $361,000, respectively for the three-month period ended Nov. 30, 2002. As at Dec. 31, 2003, the company had 23,133,014 common shares outstanding.
Under Nexia's current operating plan, management believes that the company's current cash, cash equivalents, short-term investments and other current assets should be sufficient to finance its operations and capital needs through early into fiscal 2006.
Conference call and Webcast
Nexia will be holding a conference call on Jan. 28, 2004, at 4:10 p.m., and this call will be broadcast live on the Web at www.nexiabiotech.com.
WARNING: The company relies upon litigation protection for "forward-looking" statements.
CONSOLIDATED STATEMENT OF OPERATIONS
AND DEFICITS
Three months ended Nov. 30
2003 2002
Revenues
Contract
revenues $ 252,700 $ -
----------- -----------
Interest income 108,554 156,208
----------- -----------
Total revenues 361,254 156,208
----------- -----------
Expenses
Research and
development 1,274,303 1,843,113
Amortization 240,414 257,359
----------- -----------
Total research
and development 1,514,717 2,100,472
Investment tax
credits and
other government
assistance (187,587) (220,340)
----------- -----------
Net research
and development 1,327,130 1,880,132
Business
development 360,713 466,225
Administrative 350,769 401,021
Amortization 36,987 44,017
Loss (gain) on
exchange rate 18,522 (1,801)
Interest on
long-term debt 9,235 15,943
Restructuring
costs 120,457 -
----------- -----------
Total expenses 2,223,813 2,805,537
----------- -----------
Net loss $ 1,862,559 $ 2,649,329
----------- -----------
Deficit,
beginning of
period 40,251,289 29,267,289
----------- -----------
Deficit,
end of period $42,113,848 $31,916,618
=========== ===========
Basic and
diluted (loss)
per share $ 0.08 $ 0.12
Nexia's Protexia shown to protect animals
2004-01-22 08:24 ET - News Release
Dr. Jeffrey Turner reports
NEXIA ANNOUNCES THAT PROTEXIA(TM) MEETS MILITARY'S PRIMARY OBJECTIVE; IN VIVO EFFICACY MILESTONE
Nexia has received positive results from the Protexia in vivo efficacy studies conducted by the United States Army's Institute for Chemical Defense (ICD).
The studies evaluated the ability of Protexia, a recombinant form of human butyrylcholinesterase (BChE), to protect laboratory animals from the toxic effects of nerve agents. The experimental program is a technical collaboration between ICD and Nexia. Nexia purified the Protexia from the milk of transgenic goats and ICD evaluated Protexia for its ability to protect animals from the toxic effects of organophosphate nerve agents. The results of these studies will be the subject of a peer reviewed, joint publication from the U.S. Army Medical Research and Materiel Command (USAMRMC) and Nexia later this year.
"The U.S. Army's demonstration of Protexia's in vivo efficacy is an important independent assessment. Protexia clearly protected all the animals in the study. These positive in vivo efficacy results with recombinant BChE are consistent with the army's research experience with plasma-derived BChE. We now know that Protexia can both protect animals and neutralize a wide range of nerve agents," commented Jeffrey D. Turner, president and chief executive officer of Nexia Biotechnologies. A recombinant source of BChE is important if the full-market needs for bioscavengers like BChE are to be realized to protect DoD personnel and treat the public. This has created great impetus for expanding the production of Protexia via the company's transgenic goats and initializing the development toward making clinical grade Protexia.
Nexia is working jointly with the USAMRMC under a broad agency announcement (BAA) contract and a co-operative research and development announcement (CRADA), and a memorandum of understanding with Defence R&D Canada Suffield (DRDC Suffield) to advance Protexia.
Protexia program update
Under the Protexia development plan announced in November, 2003, three key milestones were expected to be completed within 12 months:
the first milestone was to demonstrate in vitro binding and neutralization by Protexia of a variety of nerve agents, including soman, sarin, VX and tabun. This was successfully achieved on Nov. 20, 2003;
the second was to perform in vivo challenge studies with nerve agents to demonstrate that Protexia is efficacious as a protective agent in animal models. Today's results mark the successfully completion of this milestone; and
thirdly, continuing early preclinical tests, including pharmacokinetic studies, to determine residence time of Protexia in animal models, should yield results shortly.
The data generated from these experiments clearly showed similarities between Protexia and HuBChE and thus are important for the decision to transition into a development program and attract additional government development funding. Studies with HuBChE in rodents and non-human primates have demonstrated significant protection against the lethal effects of nerve agent intoxication.
Based on regulations published by the U.S. FDA Animal Efficacy Rule (Federal Register 67 (105) pg. 37988-98, May 31, 2002), there is now an established regulatory pathway for FDA review for medical countermeasures for chemical weapons defence. Under this legislation, efficacy studies on humans to demonstrate protection from nerve agents would be considered unethical. Products, like Protexia, would likely be required to present extensive animal efficacy data along with human safety data. In February, 2003, pyridostigmine bromide, was the first drug to be licensed by the FDA under these rules.
Based on discussions with both USAMRICD and DRDC Suffield, Nexia believes that Protexia, if and when approved by regulatory authorities, may be used for prophylaxis and treatment in military markets. Additionally, Protexia could also be used by local law enforcement and first responder personnel. Prophylaxis involves the pretreatment of military personnel and civilian first responders who may be exposed to nerve agents. The treatment indication of Protexia would be a therapy for casualties on the battlefield or victims of terrorist nerve agent attacks.
More information concerning a general description and background of BChE and the Protexia program can be obtained at www.nexiabiotech.com.
Conference call and Webcast
Nexia will be holding a conference call on this matter in conjunction with its annual general meeting, its programs updates and its first quarter 2004 financial statements update on Jan. 28, 2004, at 16:10, and this call will be broadcast live on the Web at www.nexiabiotech.com.
About USAMRMC
USAMRMC develops medical countermeasures to chemical warfare agents and trains medical personnel in the medical management of chemical casualties and is a recognized leader in this field.
WARNING: The company relies upon litigation protection for "forward-looking" statements.
Nexia up 25.33% in U.S. today.
NEXIA BIOTECHNOLOGIES INC COM ISIN#CA65334K1057 (NXBTF) Trade Set Alerts!
Quote as of 11/20/2003 17:28 ET
Chart
Delayed / Real-Time
Last: 0.9400
Change: +0.1900 25.33%
Bid: N/A
Ask: N/A
Tick: Down
Vol.: 9,500
Sure looks like it!
Thanks for the news.
http://biz.yahoo.com/cnw/031029/a_nexiabiotec_results_1.html
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Press Release Source: NEXIA BIOTECHNOLOGIES INC.
Nexia Announces 2003 Year-End Financial Results and Provides a Corporate Update
Wednesday October 29, 7:30 am ET
MONTREAL, Oct. 29 /CNW Telbec/ - Nexia Biotechnologies Inc. (TSX: NXB - News) today announced its audited financial results for the fiscal year ended August 31, 2003 and reported revenues of $1.3 million and a net loss of $10.98 million. Nexia also provided updates to its Protexia(TM) and BioSteel(R) Programs.
Nexia's 2003 Highlights:
PROTEXIA(TM)
- Announced its new biopharmaceutical program, Protexia(TM), a
protein initially being developed to counter the toxic effects of
nerve agents.
- Purified small amounts of Protexia(TM) from the milk of a few
transgenic goats (induced lactation).
- Was awarded a US$2.67 million research contract from the U.S. Army
to support the feasibility of producing Protexia(TM) in transgenic
animals.
- Signed a Cooperative Research and Development Agreement (CRADA)
with the U.S. Army to conduct proof-of-concept studies with
Protexia(TM).
- Signed a Memorandum of Understanding with the Canadian Department
of National Defence to support in vivo studies of Protexia(TM).
BIOSTEEL(R)
- Was awarded a $500,000 Defence Industry Research (DIR) grant from
the Canadian Department of National Defence.
- Experienced delays and technological challenges but continued to à
work towards developing BioSteel(R) for both fibre and
non-fibre applications, such as use in composites. Nexia will
continue to work towards developing a commercializable fibre.
- Received clarification from the U.S. Food and Drug Administration
that BioSteel(R) sutures will require clinical data to obtain
licensure for marketing.
- The Company will concentrate its farm operations at the
St. Telesphore facilities.
CORPORATE
- Reported grant and contract revenues of $929,000.
- Effected a cost-reduction program to extend its financial
resources.
- Discontinued its Tissue Plasminogen Activator (tPA) program.
Protexia(TM) Program Update
Nexia is developing a recombinant version of human butyrylcholinesterase (Protexia(TM)), a bioscavenger which can be used as a medical countermeasure for nerve agents. Nexia continues to collaborate with both the U.S. Army Institute of Chemical Defense and Defence R&D Canada-Suffield to test Protexia(TM) in both in vitro and in vivo model systems. Three key milestones are targeted within the next 12 months:
- First, to demonstrate in vitro binding and neutralization by
Protexia(TM) of a variety of nerve agents, such as VX and tabun.
Disclosure by the U.S. Army of the results of these experiments is
expected at the Joint Service Scientific Conference on Chemical &
Biological Defense in Towson, MD, on November 20, 2003.
- Second, conduct early pre-clinical tests, including pharmacokinetic
studies, to determine residence time of Protexia(TM) in the circulation
of an animal model.
- Third, perform in vivo challenge studies to demonstrate that
Protexia(TM) is efficacious as a protective agent in animal models.
The data generated from these experiments are important for the decision to transition into a development program and attract new government development funding.
BioSteel(R) Program Update
Regarding the BioSteel(R) program, fibre development activity in conjunction with Nexia's partner, Acordis Speciality Fibres Ltd., is ongoing with a target of achieving the required strength properties in 2004. Concerning BioSteel(R) suture development, Nexia is continuing to evaluate the nature and scope of clinical data which will be required to support a Pre-Market Approval (PMA) filing with the U.S. Food and Drug Administration. Nexia's ongoing BioSteel(R) activities include a number of applications- specific material evaluations that may result in partnered development programs.
In addition, the technological challenges experienced with the BioSteel(R) program and delays have resulted in a number of changes in the program direction with respect to the capacity requirements for transgenic production of BioSteel(R). The Company will concentrate its farm operations at the St. Telesphore facilities and as a result, the Company has recorded a write-down of $829,000. The Company has decided today to close its facility in Plattsburgh and expects to record a charge of $120,000 in the first quarter of 2004.
Financial review
The net loss for fiscal year 2003 decreased by $0.24 million to $10.98 million from $11.22 million for fiscal year 2002. The decease in the overall loss was a result of reductions in expenditures across all broad spending categories, including R&D, Business Development and Administrative expenses, of approximately $910,000, increases in total revenues of $368,000, due to the start of the research contract with the U.S. Army to develop Protexia(TM) and increases in investment tax credits and other government assistance of $189,000. The overall reductions in spending were offset by the costs of restructuring implemented in May 2003 of $627,000, a write-down of property, plant and equipment of $829,000 and a write-down of intellectual property of $19,000.
Liquidity and capital resources
Nexia had cash, cash equivalents and short-term investments of $16.97 million at August 31, 2003 a decrease of $10.15 million from $27.12 million as at August 31, 2002. In addition, Nexia had $760,000 of investment tax credits receivable and $1.05 million of other current assets. The major uses of funds during 2003 included $8.82 million used for operations and $1.07 million invested in plant, equipment and intellectual property, compared to $10.77 million and $2.61 million respectively during 2002. Under Nexia's current operating plan, management believes that the Company's current cash, cash equivalents, short-term investments and other current assets should be sufficient to finance its operations and capital needs for at least 20 months.
CONSOLIDATED BALANCE SHEETS
As at August 31 (audited)
2003 2002
$ $
-------------------------------------------------------------------------
ASSETS
Current
Cash and cash equivalents 552,383 3,069,425
Short-term investments 16,415,440 24,048,111
Investment tax credits receivable 760,000 615,000
Receivables 649,450 353,024
Prepaids and other assets 400,930 439,510
-------------------------------------------------------------------------
Total current assets 18,778,203 28,525,070
Property, plant and equipment 5,464,259 6,955,291
Intellectual property 1,434,190 1,143,121
-------------------------------------------------------------------------
25,676,652 36,623,482
-------------------------------------------------------------------------
-------------------------------------------------------------------------
LIABILITIES AND SHAREHOLDERS' EQUITY
Current
Accounts payable and accrued liabilities 879,199 955,252
Deferred revenues 341,000 -
Current portion of long-term 191,142 294,530
-------------------------------------------------------------------------
Total current liabilities 1,411,341 1,249,782
Long-term debt 154,490 345,633
-------------------------------------------------------------------------
1,565,831 1,595,415
-------------------------------------------------------------------------
Shareholders' equity
Capital stock 64,150,110 64,295,356
Contributed surplus 212,000 -
Deficit (40,251,289) (29,267,289)
-------------------------------------------------------------------------
Total shareholders' equity 24,110,821 35,028,067
-------------------------------------------------------------------------
25,676,652 36,623,482
-------------------------------------------------------------------------
-------------------------------------------------------------------------
CONSOLIDATED STATEMENTS OF OPERATIONS
AND DEFICIT
Years ended August 31 (audited)
2003 2002
$ $
-------------------------------------------------------------------------
REVENUES
Contract revenues 712,000 -
Interest income 583,029 926,983
-------------------------------------------------------------------------
1,295,029 926,983
-------------------------------------------------------------------------
EXPENSES
Research and development 7,121,506 7,570,300
Amortization of property, plant
and equipment and Intangible assets 1,121,468 1,015,584
-------------------------------------------------------------------------
Total research and development 8,242,974 8,585,884
Investment tax credits and other
government assistance (1,085,972) (896,764)
-------------------------------------------------------------------------
Net research and development 7,157,002 7,689,120
Business development 1,734,876 1,950,689
Administrative 1,598,299 1,939,741
Amortization of property, plant
and equipment 179,346 163,526
Foreign exchange loss (gain) 82,833 (12,882)
Interest on long-term debt 51,732 86,706
Restructuring costs 627,281 -
Write-down of property, plant and equipment 828,557 -
Write-down of intellectual property 19,103 330,000
-------------------------------------------------------------------------
Total expenses 12,279,029 12,146,900
-------------------------------------------------------------------------
Net loss for the year 10,984,000 11,219,917
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Deficit, beginning of year 29,267,289 18,047,372
-------------------------------------------------------------------------
Deficit, end of year 40,251,289 29,267,289
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and diluted loss per share 0.48 0.49
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Weighted average number of shares
outstanding during the year 23,059,015 22,949,808
-------------------------------------------------------------------------
-------------------------------------------------------------------------
CONSOLIDATED STATEMENTS OF CASH FLOWS
Years ended August 31 (audited)
2003 2002
$ $
-------------------------------------------------------------------------
OPERATING ACTIVITIES
Net loss for the year (10,984,000) (11,219,917)
Add items not affecting cash:
Amortization of property, plant
and equipment 1,212,278 1,085,982
Amortization of intellectual property 88,536 93,128
Non-cash restructuring charges 122,941 -
Foreign exchange (gain)/loss 33,155 312
Write-down of property, plant and
equipment 828,557 -
Write-down of intellectual property 19,103 330,000
-------------------------------------------------------------------------
(8,679,430) (9,710,495)
Changes in non-cash working capital
balances relating to operations (137,899) (1,056,321)
-------------------------------------------------------------------------
Cash flows relating to operating
activities (8,817,329) (10,766,816)
-------------------------------------------------------------------------
INVESTING ACTIVITIES
Acquisition of property, plant
and equipment (672,744) (2,308,065)
Additions to intellectual property (398,708) (302,837)
Purchase of short-term investments (19,166,204) (24,203,872)
Maturity of short-term investments 26,798,875 33,109,719
-------------------------------------------------------------------------
Cash flows relating to investing
activities 6,561,219 6,294,945
-------------------------------------------------------------------------
FINANCING ACTIVITIES
Issuance of common shares 66,754 236,628
Repayment of long-term debt (294,531) (282,446)
Repayment of obligations under
capital leases - (64,804)
-------------------------------------------------------------------------
Cash flows relating to financing
activities (227,777) (110,622)
-------------------------------------------------------------------------
Effect of exchange rate changes on cash
and cash equivalents (33,155) (312)
-------------------------------------------------------------------------
Net change in cash and cash equivalents
during the year (2,517,042) (4,582,805)
Cash and cash equivalents,
beginning of year 3,069,425 7,652,230
-------------------------------------------------------------------------
Cash and cash equivalents, end of year 552,383 3,069,425
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Supplemental cash flows information
Cash paid during the year for:
Interest 51,732 86,706
-------------------------------------------------------------------------
About Nexia
Nexia develops and manufactures complex recombinant proteins for use as biomaterials and biopharmaceutical products with medical and industrial applications. The Company's lead group of products under development is BioSteel(R) recombinant spider silk for use in medical and industrial applications. Protexia(TM) is Nexia's newest program in our product development pipeline. For more information, please visit Nexia's website at www.nexiabiotech.com .
Except for the historical information presented herein, matters discussed
herein may constitute forward-looking statements that are subject to
certain risks and uncertainties that could cause actual results to differ
materially from any future results, performance or achievements expressed
or implied by such statements. Statements that are not historical facts,
including statements preceded by, followed by, or that include the words
"believes"; "anticipates"; "intends"; "plans"; "expects"; "estimates"; or
similar statements are forward-looking statements. Such statements
reflect management's current views and are based on certain assumptions.
Actual results could differ materially from those currently anticipated
as a result of a number of factors, including risks and uncertainties
discussed in Nexia's filings with Canadian regulatory authorities. An
additional business risk associated with the Protexia(TM) program relates
to the fact that large purchases are expected to be made from a few
customers. Changes in demand from these customers could significantly
affect our program. There can be no assurance that such development
efforts will succeed, that such products will receive required regulatory
clearance or that, such products would ultimately achieve commercial
success.
For further information
Media Contact: Jeffrey D. Turner, Ph.D., President and CEO, Nexia Biotechnologies Inc., (450) 424-8920, jturner@nexiabiotech.com
Investor Relations Contact: Jim McDonald, Executive Vice-President - Corporate Development, Nexia Biotechnologies Inc., (450) 424-8912, jmcdonald@nexiabiotech.com
--------------------------------------------------------------------------------
Source: NEXIA BIOTECHNOLOGIES INC.
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Nexia gets encouraging news on Protexia from U.S. Army
2003-11-20 11:38 ET - News Release
Mr. Jeffrey Turner reports
THE U.S. ARMY AND NEXIA ANNOUNCE PROTEXIA(TM) RESULTS
Nexia Biotechnologies client, the U.S. Army Medical Research Institute of Chemical Defense (USAMRICD), presented results from its Protexia program at the Joint Services Scientific Conference on Chemical and Biological Defense in Towson, Md.
The results indicate that Protexia, manufactured in transgenic goats, binds a broad spectrum of nerve agents and has properties very similar to human butyrylcholinesterase (HuBChE) when compared in vitro under identical conditions. The data also indicate that Protexia is capable of binding stoichiometrically with nerve agents on a one-molecule-to-one-molecule basis.
Protexia program update
Nexia is developing a recombinant version of human butyrylcholinesterase (Protexia), a bioscavenger, as a medical countermeasure for nerve agents. Nexia continues to collaborate with both the USAMRICD and Defence R&D Canada Suffield (DRDC Suffield) to test Protexia in both in vitro and in vivo model systems. Three key milestones have been targeted within the next 12 months:
first, to demonstrate in vitro binding and neutralization by Protexia of a variety of nerve agents, including soman, sarin, VX and tabun. Today's disclosure by the U.S. Army of the results of these experiments marks the successful completion of this first milestone;
second, conduct early preclinical tests, including pharmacokinetic studies, to determine residence time of Protexia in animal models; and
OK Why the action? What do the insiders know? There have been over 85000 shares traded in canada and the price is down under $1cdn
If you look at the chart in the header you'll see it closed on its 50 day moving average. That should act as support I think. Hope to get back in before the next up move. Maybe next time we can blow through $1.50 Cdn.
Nexia down 4.35% to CDN$ 1.10 on 62,500 volume
Nexia Biotechnologies Inc. (NXB:TSX) Create a Membership or Login
NXB: Price Change % Change Volume Day High/Low
1.10 -0.05 -4.35% 62,500 1.20 / 1.10
52WK High/Low
3.10 / 0.80
Nexia up 4.92% to US$.96 today on 300 shares volume.
NEXIA BIOTECHNOLOGIES INC COM ISIN#CA65334K1057 (NXBTF) Trade Set Alerts! As of 10/03/2003
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Nwxia down 4.92% CDN$ on 28,800 volume today
Nexia Biotechnologies NXB-T Last Trade:Sep 26, 2003 15:56 EST
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Last: C$ 1.160 Net Change: C$ -0.060 % Change: -4.92%
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52-Week Low 0.780 Yield 0.00
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Nexia down 7.77% today US$ on 200 shares volume
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NXBTF unchanged on US - NXB down 9.63% today on Canadian market
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From Harrisdirect - my broker
Nexia Biotechnologies to Work on Nerve Gas Antidote from Goat's Milk
By Brian Carnell
Wednesday, April 23, 2003
Nexia Biotechnologies made headlines in 2002 when it announced it had created genetically modified goats that expressed a protein unique to spiders its milk. This month Nexia announced that it would work with the Canadian military to develop a genetically modified goat that would express a powerful nerve gas antitoxin in its milk.
Its research there will focus on production of a recombinant version of butyrycholinesterace (BChE). BChE is found in small quantities in the blood of many animals, and acts as a defense against nerve agents. It binds with the components of nerve agents and renders them harmless within the blood stream. Of course in a full-fledged nerve gas attack, this small amount of naturally occurring BChE is quickly overwhelmed.
Nexia will try to create a GM goat that produces BChE in large quantities that could then be prepared as an injection which military forces could use on the battlefield to better protect themselves against nerve agents such as sarin gas.
According to Nexia, studies in animals have shown that injections of relatively large amounts of BChE have protected lab animals from such agents, but the inability to produce large quantities of it has precluded BChE from applications in human beings.
Source:
Fighting Nerve Gas: Would Use Milk of Transgenic Animals. National Post, April 2, 2003.
Protexia™ - A Bioscavenger. Nexia Biotechnologies, 2003.
http://www.animalrights.net/articles/2003/000140.html
AnimalRights.Net
Debunking the animal rights movement
Initial investment and other Nexia info:
"How did Nexia get started?
Nexia was founded in 1993 in Montreal, when technology and intellectual property, developed in Dr. Jeffrey Turner's laboratory at McGill University, was combined with venture capital support from MDS Capital Corp., and Innovatech Grand Montreal. The business concept was the production of rare recombinant proteins in the milk of domesticated dairy animals. The company was then supported by private investors from the Ontario Teachers Pension Plan, RBC Capital Corp., and CDP-Sofinov in three more rounds of funding. In Dec. 2000, Nexia completed the largest Initial Public Offering in the history of Canadian Life Sciences, raising CND $42.4 million to commercialize spider silk-based biomaterials and biopharmaceuticals in transgenic dairy goats.
What is Nexia's main area of research?
Nexia has a worldwide exclusive proprietary position in the development and manufacturing of recombinant spider silk (BioSteel®). Nexia has a vertically integrated R&D effort. Our partners work to find spiders that make better and different webs and then understand spider genetics. Nexia then transfer these genes, using modern reproductive techniques, into dairy goats to produce silk proteins in their milk. Lastly, the silk proteins are spun into fibers for incorporation into new products.
Nexia also uses its transgenic goats to make recombinant pharmaceuticals. The manufacturing power of this system is evident when one understands that only 10 goats, currently living in Nexia's farm near Montreal, produce enough product to supply the world market for tPA (tissue plasminogen activator) a drug used to treat heart attacks and blood clots.
What obstacles did the company overcome?
Two main obstacles were overcome to date, during the growth of Nexia; understanding and mimicing biological complexity and understanding product development specifications. Nexia works on very complex proteins some of which cannot be manufactured economically with other biological systems. We first need to learn about the target genes and proteins involved, a process that is very demanding, and then use this knowledge to reproduce an authentic copy within our goat system.
Product specifications within the market place are dramatically different depending on the application of the spider silk. Nexia has managed these very different businesses by hiring specialists in each product development area, i.e. medical devices and industrial performance fibers, to interact with our client companies.
How did Nexia make its mark in the biotech industry?
Animal transgenics is an emerging manufacturing technology for the production of large quantities of authentic and rare recombinant proteins on a cost effective basis. Nexia has been recognized for innovative products and technical solutions to reduce costs and compress development time lines. For example, our BELE (Breed Early, Lacattion Early) goat genetics require just 8 months from gene to recombinant protein in the milk. This is a dramatic improvement compared to standard goats, sheep or cattle. On the product development side, Nexia is recognized internationally for its pioneering R&D in the large-scale production of recombinant spider silk and the spinning methods required to make useful fibers from this novel biomaterial.
Where is the company now in its corporate development?
Corporate development is focusing on product development and commercialization of BioSteel-based products. We develop business relationships where Nexia manufactures the recombinant proteins and spins them into fibers useful for particular applications either alone or with partners. BioSteel-based products are being evaluated for development of medical device applications, e.g. opthalmic micro-sutures; technical sporting gear, eg. high performance, biodegradable fishing line, and other industrial applications e.g. soft body armor for the military and law enforcement communities.
In the past year, what's been the most exciting accomplishment for Nexia?
Nexia, working with the US Army, was the first R&D group to produce authentic, recombinant spider silk fibers with significant mechanical properties [Science 295:472, 2002]. Our success was based on "biomimicry." First, our belief was confirmed that the similarities between the spider silk gland and the goat milk gland would be predictive of our ability to produce spider silk proteins in mammary cells. Second, when this silk protein was forced through a high shear spinnerette, the proteins self-assembled into strong spider silk fibers. Spider silk was chosen because it is considered by many to be the "Holy Grail" of material sciences, having unparalleled combination of strength, toughness, flexibility and lightness. Supply of our recombinant spider silk, termed BioSteel®, for applications in medicine, industry, military and technical sporting gear will be produced with herds of transgenic goats making spider silk in their milk. BioSteel technology combines the performance of advanced polymers within a sustainable, ecologically responsible manufacturing process and product.
What is Nexia's 10-year prognosis for the Canadian biotechnology industry?
The Canadian biotechnology sector will continue to develop superior, innovative small to medium sized companies because of the cost effective R&D programs. First, strong legislative support for biotechnology in the form of investment tax credits at the provincial and federal levels allows leverage of costly venture capital. Secondly, the weak Canadian dollar (compared to USD) provides cost effective funding of world-class research at Canadian universities. These factors combine to provide technical advances that are the basis of new ventures. Unfortunately, large Canadian biotechnology companies can be expected to be few because of limitations on large amounts of capital, labor and infrastructure.
In Nexia's opinion, what is the most important international issue facing the international biotech community, and how can we best handle it?
Manufacturing capacity of recombinant biopharmaceuticals and biomaterials is a major concern for international biotech community. Industry drivers include: an ever increasing number of protein-based drugs and medical devices clearing regulatory hurdles; expansion into large non-traditional markets e.g. China and a burgeoning R&D effort focusing on new protein products. Satisfying these demands will require expansion of existing traditional fermentation and downstream facilities which is capital intensive and stimulate the adoption of novel, low capital cost manufacturing technology such as animal or plant transgenic systems. Transgenics will provide many developing economies with a domestic manufacturing base for complex drugs and biomaterials with manageable capital expenditures."
From:
BIO 2002 International Biotechnology Convention & Exhibition
Life Advances
June 9-12, 2002
Toronto, Ontario, Canada
Metro Toronto Convention Centre
http://www.bio2002.org/press/guide/nexia.asp?l=en
I don't think so but real close. I think this could go to $3 in fairly short order. There's not a lot of float on it.
Cheers,
Oh great so I bought your paper hehehehe...
I think it should do ok...
Sam
This will move on news but when the news comes is the big question.
I sold the last of my position from 1.12 1.22 and 1.23 today for 1.39 1.34 and 1.32.
May buy it back if it drops below 1.30 again.
Good luck!!
Hey Guys,
I just took a position in NXB....
Chart looks great...
Hope she starts to move up soon...
UT,,,
McGill Office of Technology Transfer fact sheet on Nexia Biotechnologies:
https://upload.mcgill.ca/ott/nexia.pdf
471,100 NXB shares are unaccounted for in CDP press releases:
September 15, 2003 CDP sold 125,000 shares of NXB holding 2,218,044
May 13, 2003 CDP sold 64,000 shares of NXB holding 2,689,144
Are there other press releases missing?
It looks like CDP sold 63,400 common shares of Nexia
Biotechnologies inc., or 0.28 % of such shares outstanding at a price of $ 1.03 per share on or about May 13, 2003:
Canada NewsWire
Give us your message. We'll give you the world.
CAISSE DE DEPOT ET PLACEMENT DU QUEBEC
Attention Business Editors:
CDP Capital Technologies Sells Shares of Nexia Biotechnologies Inc.
MONTREAL, May 13 /CNW Telbec/ - The Caisse de dépôt et placement du
Québec, announces that its subsidiary, CDP Capital - Technology Ventures has
sold, on the Toronto Stock Exchange a total of 63,400 common shares of Nexia
Biotechnologies inc., or 0.28 % of such shares outstanding at a price of
$ 1.03 per share.
Through this transaction, CDP Capital - Technology Ventures now holds
2,689,144 common shares of the company, or 11.69 % of such shares outstanding.
CDP Capital - Technology Ventures also holds 33,333 share warrants for common
shares. If those warrants were to be exerciced, the total interest of CDP
Capital - Technology Ventures in the company, on a partially diluted basis,
would be 11.81 %.
This transaction was made for investment purposes and CDP Capital -
Technology Ventures could increase or decrease its investment in Nexia
Biotechnologies inc. depending on market conditions or any other relevant
factor.
-30-
For further information: Lucie Frenière, Public Affairs Services, Caisse
de dépôt et placement du Québec (CDP), (514) 847-5949
CAISSE DE DEPOT ET PLACEMENT DU QUEBEC has 199 releases in this database.
General Inquiries - cnw@newswire.ca
Technical Issues - webmaster@newswire.ca
© 2002 Canada NewsWire Ltd. All rights reserved.
Since I didn't know what CDP was I looked at the Stockhouse US news and found this:
Caisse de depot et placement du Quebec - CDP Capital - Technology Ventures sells shares of Nexia Biotechnologies Inc.
9/15/03
MONTREAL, Sep 15, 2003 (CNW Telbec via COMTEX) --
The Caisse de depot et placement du Quebec, announces that its subsidiary, CDP Capital - Technology Ventures has sold, on the Toronto Stock Exchange a total of 125,000 common shares of Nexia Biotechnologies inc., or 0.54% of such shares outstanding at a price of $1.36 per share.
Through this transaction, CDP Capital - Technology Ventures now holds 2,218,044 common shares of the company, or 9.60% of such shares outstanding. CDP Capital - Technology Ventures also holds 33,333 share warrants for common shares. If those warrants were to be exerciced, the total interest of CDP Capital - Technology Ventures in the company, on a partially diluted basis, would be 9,73%.
This transaction was made for investment purposes and CDP Capital - Technology Ventures could increase or decrease its investment in Nexia Biotechnologies inc. depending on market conditions or any other relevant factor.
VIEW ADDITIONAL COMPANY-SPECIFIC INFORMATION: http://www.newswire.ca/cgi-bin/inquiry.cgi?OKEY=33612
For further information: Lucie Freniere, Public Affairs Services, Caisse de depot et placement du Quebec (CDP), (514) 847-5949
News release via Canada NewsWire, Montreal 514-878-2520
Copyright (C) 2003 CNW, All rights reserved
The following link is for the Nexia Biotechnologies company snapshot:
http://www.stockhouse.com/comp_info.asp?view=&Displaycurrency=&symbol=NXB&table=list
The following link is for Stockhouse news about Nexia Biotechnologies:
http://www.stockhouse.com/comp_info.asp?view=news&Displaycurrency=&symbol=NXB&table=list
The following is the latest news story:
http://www.stockhouse.com/news/news.asp?newsid=1794716&tick=NXB
The following company is a potential customer for Nexia's Biosteel. I believe they use kevlar now and could use an improved fiber:
DHB Industries Inc. is a publicly traded (AMEX:DHB) company comprised of two divisions: DHB Armor Group and DHB Sports Group. DHB Armor Group consists of Point Blank Body Armor, Inc. and Protective Apparel Corporation of America (PACA), global leaders in the development, manufacturing and distribution of innovative, technically advanced bullet and projectile resistant garments, bullet resistant and fragmentation vests, bomb projectile blankets, and related ballistic accessories and technologies for the United States Military and Law Enforcement Agencies. DHB Sports Group (NDL Products, Inc.) manufactures and distributes protective athletic apparel and equipment as well as a line of therapy products.
I used to own some shares of DHB but I sold them - I am not suggesting that anyone buy this stock, but this company or some other company could improve their products with Biosteel.
This is from the Stockhouse board and I have to agree something is brewing. That last news release was a non event in my opinion and shouldn't have affected the share price.
I think that this was in reaction to the private deal that took place earlier this week.
I don't think so…, CDP (who manage funds for the Quebec government's pension plan) buy and sell shares of various companies all the time. And it wasn't really a "private deal"…, they sold their shares in the open market, just like you or I would. The last time they sold some NXB shares was in May and the stock price didn't react at all.
Whatever's happening this time appears to be the start of an upswing due to pending news. On Friday and Monday the daily number of trades, and the daily volume, increased more than 10-fold over the averages for the past 3 months. The price has held fairly well at 1.30, which is also a significant increase over recent levels. Obviously "andora" can't really know if there's a news release pending and doesn't have a clue what it may be about, but his guess will likely prove to be correct…, something's coming. My speculation is that it has to do with the commercialization of BioSteel. In July Nexia stated that "fibre development activity in conjunction with Nexia's partner, Acordis Speciality Fibres Ltd., is continuing with a target of achieving the required strength properties by the fall of 2003". They must have been close to achieving their target at that time, or they wouldn't have set such a tight timeline.We shall see!!
David Raine
Vancouver
There is some discussion on Stockhouse about NXB. Mostly about a Quebec pension plan holder selling shares and discussion about a July press release.
I just got into this at $1.05 cdn, and am still learning.
Sorry, I can't post the link. It is only available through the group holding my canadian RRSP.
NXBTF is up another 8.74% to US$ 1.12 today, September 16, 2003:
NXBTF 1.1200 +0.0900 + 8.74% (Volume was 6,000)
The above is from my broker Harrisdirect - Quicken has average volume at 1,280.
I would also like to see a link, very little information about Nexia is available through Harrisdirect or Quicken
Regards,
guy20817
Post a link if you can.
Thanks...
Very active the last few days. I have seen a report expecting a $3.50 cdn price
Yes. Over 400,000 shares traded today on the TSE. There was a similar amount traded on Friday. Unusually high volume for this stock. I think a double from here is quite possible...
NXBTF is up 15.73% to US$1.03 today on 6,000 shares volume - good decision.
I bought some today. The chart is perking up.
I am talking to myself here. Anybody know anything about Biosteel?
Regards,
guy20817
I bought 1000 shares on 8/28/2003 on news that the "Secret of silk may have been solved" - MSNBC.
Biomedical engineers at Tufts University say they may have worked out how spiders and silkworms are able to produce such strong fibers. "The entire process is controlled by the amount of water, which is so simple."
Research was published in the science journal Nature. Bioengineers at Tufts have developed a strategy for using silk to repair damaged knee lilgaments. Some companies expressed an interest in using silk to make ultra-strong clothing, hiking gear and outdoor equipment.
Stock price went down after I bought. Is this competition for Nexia? Is this good for Nexia?
I bought 2000 shares and sold 1000 after it doubled. (U.S. Dollars)
12/11/2002 $1,175.00 SELL 1000 SHARES OF NXBTF @ 1.27000
11/05/2002 $1,405.00- BUY 2000 SHARES OF NXBTF @ 0.64500
I had an order in for more shares yesterday, but it didn't execute.
I was most interested in the possible application of the fiber to protective vests for police & military applications.
Guy
Hi Guy
I take it the stock price drop is due to the FDA decision that the spider silk sutures will need to go to clinical trials.
I also think that the stock price has strong support around the 80-90 cent cdn level. If it drops below 80 I might get worried.
I don't own any of the stock right now. I started the board because the company came to my attention when I saw it on a television program here in Canada. I think they have a great idea and that the market for their product could be huge. I may buy some in the near future.
Welcome to the thread and good luck.
Trading Fool,
Thank you for posting this message and for starting this board. I have owned Nexia Biotechnologies (NXBTF in the US) since November 2002. I live in Bethesda, Maryland not to far from the U.S. FDA. I was wondering what happened to the stock price.
Do you own Nexia?
I see by your bio that you are a Professional Engineer. I am also a Professional Engineer - B.S.E.E. with a Biomedical major. I also did graduate work in Clinical Engineering at Johns Hopkins Medical School.
Do you think that Nexia is prepared to deal with FDA?
Sincerely,
Guy Hammer
The stock has fallen recently on news:
UPDATE - Nexia's spider silk will need clinical tests
TORONTO, June 18 (Reuters) - The U.S. Food and Drug Administration (News - Websites) has decided that Nexia Biotechnologies's (Toronto:NXB.TO - News) spider-silk sutures must undergo clinical trials before being approved, the company said on Wednesday, which may delay commercialization of its lead product.
Nexia chief executive Jeffrey Turner said he did not know how long it would take to bring the sutures to market or what the cost of clinical trials would be. But he said the FDA's decision was not a setback for Nexia, which has enough cash to cover operations until November 2005.
Last month the Montreal-based company said it would lay off about 30 of its about 100 employees as it tried to cut costs by about 40 percent to C$600,000 a month.
Nexia stock fell 4 percent on the Toronto Stock Exchange (News - Websites) on Wednesday as more than 106,000 shares changed hands. Over the previous 10 days average daily trading volume had been about 72,000 shares.
The company had hoped the FDA would give the sutures the green light without clinical tests under a fast-track program that approves, without testing, new products that are similar to existing devices.
Nexia said on Wednesday the FDA had told the company that its silk sutures, which are threads used to stitch wounds, and the way they are made "raised questions" that had not been previously considered for such material.
Nexia's spider silk, called BioSteel, is made from milk from goats that have a spider-silk gene. The manufacturing process isolates the spider silk proteins from the milk and spins them into a fine fiber stronger than steel.
The company said the FDA will require Nexia to test its BioSteel sutures to close wounds before approving them.
"This is not like falling off a cliff or something like that," Turner said in an interview about the FDA's decision. "We are at a point where we have additional clarity but not total clarity (from the FDA)."
Nexia's shares closed down 4 Canadian cents at 96 Canadian cents in Toronto. They have fallen 45 percent this year.
($1=$1.34 Canadian)
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