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Read More...Monday 28th August 2006
NeuroMedix announces third quarter fiscal 2006 financial results
TORONTO, Aug. 28 /CNW/ - NeuroMedix Inc. ("NeuroMedix" or the "Company") (TSXV: NMX) today announced its financial results for the quarter ended June 30, 2006.
During the nine-month period ended June 30, 2006, NeuroMedix:
- Demonstrated that Minozac reduces brain proinflammatory cytokine production and loss of cognitive function in an animal model of traumatic brain injury ("TBI");
- Completed its initial public offering which resulted in gross proceeds of $3,300,000;
- Commenced trading on the TSX Venture Exchange under the symbol, "NMX"; and - Strengthened its management team.
Subsequent to June 30, 2006, NeuroMedix achieved the following milestone:
- Manufactured the first cGMP (current Good Manufacturing Practice) batch of kilogram levels of Minozac, NeuroMedix's lead drug candidate for Alzheimer's disease and related neurological disorders.
NeuroMedix continues to make progress towards the initiation of its first Phase I clinical trial. Commercial process development has been completed with a Swiss-based chemical manufacturing organization, producing cGLP (current Good Laboratory Practice) Minozac and NeuroMedix has now completed the first batch of cGMP Minozac meeting the specifications for clinical trials. In addition, NeuroMedix expects to complete dose-ranging and maximum tolerated dose studies in two species of animals and commence longer-term toxicology studies in the next couple of weeks.
"We believe we are on track to complete the cGLP pre-clinical toxicology studies required to allow us to file an Investigational New Drug application for a Phase I clinical safety study in healthy volunteers in the fourth quarter of calendar 2006," said Dr. Mark L. Pearson, Chief Executive Officer of NeuroMedix.
In May 2006, NeuroMedix announced data for its first additional indication, TBI, demonstrating that Minozac is effective in reducing brain inflammation in mice suffering TBI and in preventing the cognitive deficit that generally results from such injury. There are currently no safe drugs known that both specifically suppress the inflammatory response in the brain and are effective in the treatment of this type of brain injury. Therefore, NeuroMedix believes TBI could represent an additional very large market for Minozac. In the effort to ensure that the full value of NeuroMedix's technology is realized for its shareholders, NeuroMedix is also investigating additional uses for Minozac in animal models of multiple sclerosis and neuropathic pain.
Financial Review
For the three-month period ended June 30, 2006, NeuroMedix recorded a net loss of $628,353 ($0.02 per common and Class B share) compared to $144,603 ($0.01 per common and Class B share) for the same period in fiscal 2005. For the nine-month period ended June 30, 2006, NeuroMedix recorded a net loss of $1,055,249 ($0.04 per common and Class B share) compared to $144,603 ($0.01 per common and Class B share) for the period from incorporation on February 11, 2005 to June 30, 2005. The increased losses are reflective of costs associated with manufacturing, pre- clinical toxicology studies, research contracts, intellectual property development, consulting expenses, employee expenses and general administrative costs.
Research and development expenses were $509,483 for the three-month period ended June 30, 2006, compared to $144,595 for the three-month period ended June 30, 2005. Research and development expenses were $723,486 for the nine-month period ended June 30, 2006, compared to $144,595 for the period from incorporation to June 30, 2005. The increase in research and development expenses for both periods was primarily the result of an increase in fees paid to external service providers for items such as research, research management, manufacturing, pre-clinical toxicology studies and intellectual property as well as an increase in internal employee expenses.
General and administrative expenses were $134,993 for the three-month period ended June 30, 2006, compared to $14 for the three-month period ended June 30, 2005. General and administrative expenses were $359,596 for the nine-month period ended June 30, 2006, compared to $14 for the period from incorporation to June 30, 2005. The increase in general and administrative expenses for both periods was primarily the result of the incurrence of payroll, legal, accounting, tax, and consulting fees, board compensation, regulatory and reporting costs and general office expenses.
On January 24, 2006, under the terms of an agency agreement, NeuroMedix issued 13,200,000 common shares, including the exercise of the over- allotment option (the "Offering"), at a price per share of $0.25 for gross proceeds of $3,300,000. The net proceeds of this Offering were $2,746,618, net of issue expenses and agent's commissions of $553,382. NeuroMedix believes that it has adequate financial resources to meet anticipated expenditures until the first quarter of calendar 2007.
As a result of a lack of toxicity at much higher than therapeutic doses, NeuroMedix has been required to produce more cGMP material to determine a maximum tolerated dose to meet FDA requirements than was anticipated at its IPO in January. As noted previously, NeuroMedix has now completed its first batch of kilogram levels of cGMP Minozac and expects to complete dose-ranging and maximum tolerated dose studies in two species of animals in the next couple of weeks.
In addition, the number of pre-clinical toxicity studies required by the FDA is greater than anticipated. As a result of both of these issues, NeuroMedix now anticipates that the funds raised in its IPO will not be sufficient to complete the planned Phase I clinical studies. NeuroMedix is currently addressing the need for additional funds to support these studies and hopes to secure this funding by the end of calendar 2006.
About NeuroMedix:
NeuroMedix is a biotechnology company focused on the development of therapeutic agents for the treatment of degenerative and inflammatory diseases of the central nervous system, such as Alzheimer's disease, traumatic brain injury, neuropathic pain, age-related macular degeneration and multiple sclerosis. Our therapeutic drug candidates are based on research from a team of leading experts in the field of neuroinflammation at Northwestern University and have been demonstrated to reduce brain inflammation, to protect neuronal cells, and to prevent the loss of cognitive function in an Alzheimer's disease animal model in mice. Our lead candidate, Minozac has also been shown to reduce inflammation and prevent loss of cognitive function in mice suffering traumatic brain injury. Based on these findings, NeuroMedix is pursuing the development of its lead compound for Alzheimer's disease and traumatic brain injury in humans. NeuroMedix's shares are listed on the TSX Venture Exchange under the symbol "NMX".
Financial Information to follow:
NeuroMedix Inc.
(a development stage company)
CONSOLIDATED BALANCE SHEETS
(Unaudited)
June 30, September 30,
2006 2005
$ $
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ASSETS
Current
Cash and cash equivalents 1,729,279 18,099
Receivables 29,328 4,611
Deposits on collaborations 18,066 26,051
Deferred financing costs - 17,625
Prepaid expenses 98,562 12,500
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Total current assets 1,875,235 78,886
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Property and equipment, net 11,085 2,451
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1,886,320 81,337
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LIABILITIES AND SHAREHOLDERS' EQUITY
Current
Accounts payable and accrued liabilities 146,077 51,776
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Total liabilities 146,077 51,776
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Shareholders' equity
Share capital
Common shares 2,746,619 1
Class B shares 491,968 491,968
Contributed surplus 19,313 -
Deficit (1,517,657) (462,408)
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Total shareholders' equity 1,740,243 29,561
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1,886,320 81,337
Commitments
Guarantees
Subsequent event
-------------------------------------------------------------------------
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NeuroMedix Inc.
(a development stage company)
CONSOLIDATED STATEMENTS OF LOSS AND DEFICIT
(Unaudited)
Nine-month Three-month Three-month
period Period from period period
ended February 11, ended ended Cumulative
June 30, to June 30, June 30, June 30, from
2006 2005 2006 2005 inception
$ $ $ $ $
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EXPENSES
Research and
development 723,486 144,595 509,483 144,595 1,131,268
General and
administrative 359,596 14 134,993 14 414,334
Interest
expense 1,133 - - - 1,133
Foreign
exchange gain (2,020) - (1,319) - (2,020)
Amortization 1,716 - 572 - 1,975
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1,083,911 144,609 643,729 144,609 1,546,690
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Loss before
the
following (1,083,911) (144,609) (643,729) (144,609) (1,546,690)
Interest
income 28,662 6 15,376 6 29,033
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Net loss for
the period (1,055,249) (144,603) (628,353) (144,603) (1,517,657)
Deficit,
beginning
of period (462,408) - (889,304) - -
-------------------------------------------------------------------------
Deficit, end
of period (1,517,657) (144,603) (1,517,657) (144,603) (1,517,657)
-------------------------------------------------------------------------
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Basic and
diluted net
loss per
common and
Class B
share $0.04 $0.01 $0.02 $0.01
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Weighted
average common
and Class B
shares
outstanding 24,689,560 10,800,000 30,250,000 10,800,000
-------------------------------------------------------------------------
-------------------------------------------------------------------------
NeuroMedix Inc.
(a development stage company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Nine-month Three-month Three-month
period Period from period period
ended February 11, ended ended Cumulative
June 30, to June 30, June 30, June 30, from
2006 2005 2006 2005 inception
$ $ $ $ $
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OPERATING
ACTIVITIES
Net loss for
the period (1,055,249) (144,603) (628,353) (144,603) (1,517,657)
Add items not
involving
cash
Amortization 1,716 - 572 - 1,975
Stock-based
compensation
expense 19,313 - 6,188 - 19,313
Write-off of
receivable 8,153 - - - 8,153
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(1,026,067) (144,603) (621,593) (144,603) (1,488,216)
Changes in
non-cash
working
capital items 979 644,594 (142,482) 644,595 (8,032)
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Cash provided
by (used in)
operating
activities (1,025,088) 499,991 (764,075) 499,992 (1,496,248)
-------------------------------------------------------------------------
INVESTING
ACTIVITIES
Purchase of
property and
equipment (10,350) - - - (13,060)
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Cash used in
investing
activities (10,350) - - - (13,060)
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FINANCING
ACTIVITIES
Proceeds from
issuance of
common shares,
net 2,746,618 1 - - 2,746,619
Proceeds from
issuance of
Class B
shares, net - - - - 491,968
Increase in
promissory
note 51,133 - - - 51,133
Repayment of
promissory
note (51,133) - - - (51,133)
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Cash provided
by financing
activities 2,746,618 1 - - 3,238,587
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Net increase
(decrease)
in cash
during the
period 1,711,180 499,992 (764,075) 499,992 1,729,279
Cash,
beginning of
period 18,099 - 2,493,354 - -
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Cash, end of
period 1,729,279 499,992 1,729,279 499,992 1,729,279
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The TSX Venture Exchange does not accept responsibility for the adequacy or accuracy of this release.
Except for historical information, this press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements
involve risks and uncertainties, which may include but are not limited to, changing market conditions, the successful and timely completion of
clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties
related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.
For further information visit www.neuromedixinc.com or contact:
Mark Pearson, PhD.
Chief Executive Officer
NeuroMedix Inc.
425-503-5156
mark@neuromedixinc.com
or
Catherine Auld, CA
Chief Financial Officer
NeuroMedix Inc.
416-673-8190
cathy@neuromedixinc.com
