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Protox releases 3rd Quarter, 2005 financial statements
Tuesday, November 29, 2005 - Vancouver, British Columbia - Protox Therapeutics
Inc. announced today the release of its third quarter financial statements
for the period ending September 30, 2005.
“We continue to lay the groundwork to move PORxin™302 into Phase
I clinical trials for localized prostate cancer,” stated Fahar Merchant,
PhD, President and CEO of the Company. “We anticipate filing our first
Investigational New Drug (IND) application with the United States FDA this
quarter and commencing patient recruitment at Scott and White Hospital soon
after the IND is approved. Subsequent to quarter end we were successful in
raising more than $5.8 million in a non-brokered private placement which places
Protox on solid financial footing to fund our development plans through 2006.”
Operational highlights:
- The Company completed all non-clinical studies in rodent and non-rodent
species in order to support the IND application for PORxin™302.
- The Company completed cGMP compliant manufacturing and related CMC activities
for PORxin™302 for first in man studies.
- In October 2005, the Company entered into a clinical trial agreement with
Scott & White Memorial Hospital and Clinic in Temple, Texas (Scott &
White) to conduct a Phase 1 clinical study of PORxin™302 for the treatment
of localized, recurrent prostate cancer.
- The Company received approval from the Institutional Review Board (IRB)
of Scott & White to conduct a Phase 1 clinical study of PORxin™302
for the treatment of localized, recurrent prostate cancer. The clinical
study may begin once the IND for PRX302 has been approved by the United
States Food and Drug Administration (US FDA).
- On November 4, 2005 the Company completed a non-brokered private placement
of 9,091,600 units at a price of $0.50 per unit for total gross proceeds
of $4,545,800. Each unit comprises one common share and one common share
purchase warrant. Each warrant shall entitle the holder to purchase one
common share of Protox Therapeutics Inc. at a price of $0.65 for a period
of 24 months from the closing date of the private placement.
- On November 17, 2005, the Company completed an extension of the non-brokered
private placement for an additional 2,652,000 units on the same terms and
conditions for total gross proceeds of $1,326,000.
Overall Performance of the Company
The Company has not earned any income in any of its previous fiscal years,
other than income from interest earned on the Company's cash balances. As
at September 30, 2005, the Company had current assets of $1,642,518, as compared
to current assets of $5,121,897 at December 31, 2004. The change in current
assets can predominantly be attributed to a reduction in cash related to payments
of expenses incurred in the Company’s operations as described below.
Net Income
The Company incurred a net loss of $1,447,035 (or $0.06 per share) for the
quarter ended September 30, 2005 and a net loss of $3,978,710 (or $0.17 per
share) for the nine months ended September 30, 2005. This is compared with
a net loss of $738,962 (or $0.03 per share) and $1,513,047 (or $0.10 per share)
for the quarter and nine months ended September 30, 2004 respectively. The
increases in losses are predominantly related to the increase in research
and development expenditures and general and administrative expenses as described
below.
Research and Development
For the quarter ended September 30, 2005, the Company incurred expenses related
to research and development of $934,666. This is an increase in research and
development expenses compared to the quarter ended September 30, 2004 where
these expenses were $409,564. For the nine months ended September 30, 2005
these expenses were $2,719,092 compared to the nine months ended September
30, 2004 where these expenses were $859,614. The increase in expenditure is
directly related to the formal pre-clinical studies, manufacturing costs and
regulatory consultants for the PORxin™302 project.
General and Administrative
The Company incurred general and administrative expenses of $502,144 for the
quarter ended September 30, 2005 compared with $337,676 for the quarter ended
September 30, 2004 (Protox Pharma). For the nine months ended September 30,
2005 the Company incurred $1,249,647 in general and administrative expenses
compared with $674,003 for the nine months ended September 30, 2004. The comparative
increase in expenses for this period relates to the change in management and
the growth in the Company’s operations and includes the hiring of employees
and consultants and increases in related support services.
Interest Income
During the quarter ended September 30, 2005, the Company recorded $8,895 in
interest income compared with $9,757 for the quarter ended September 30, 2004.
During the nine months ended September 30, 2005, the Company recorded $47,255
in interest income compared with $22,915 for the nine months ended September
30, 2004. The increase in interest income relates to higher cash balances
held in interest bearing accounts due to the Arrangement Financing.
Summary of Quarterly Results
In November 2005, the Company completed a non-brokered private placement
of 11,743,600 units for gross proceeds of $5,871,800. Each unit comprises
one common share and one common share purchase warrant. Each warrant shall
entitle the holder to purchase one common share of Protox Therapeutics Inc.
at a price of $0.65 for a period of 24 months from the closing date of the
private placement.
Liquidity
As at September 30, 2005, the Company had working capital of $776,864 and
in November the Company raised $5,871,800 through a non-brokered private placement.
The Company anticipates that it will have sufficient funds to operate its
business to the end of 2006 based on its current business plan.
Company financials for the quarter ended September 30, 2005 and Management's
Discussion and Analysis will be available at www.sedar.com
About Protox Therapeutics
Protox Therapeutics Inc. is developing novel targeted cancer therapeutics
based on engineered protein toxins. Its lead programme (PORxin™) is based
on pore forming protoxins such as modified proaerolysin. PORxins™
are inactive pro-drugs that are preferentially activated at the tumour site
into potent toxins by cancer specific proteases, thereby causing cancer cell
death. The Company works in partnership with research groups at the University
of Victoria, Johns Hopkins University, Scott & White Hospital and other
research institutions. The Company’s lead candidate, PORxin™302
is being developed for the treatment of localized prostate cancer. The Company
anticipates that it will be ready to file an Investigational New Drug application
with the US Food and Drug Administration in Q4 2005 in order to seek approval
to initiate a Phase I safety study with PORxin™302.
For more information, contact:
Terry Vanderkruyk
Director, Investor Relations, Protox Therapeutics Inc.
Tel: 604-688-4376
Cell: 604-789-0844
Fax: 604-688-0173
tvanderkruyk@protoxtherapeutics.com
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