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Protox releases 2nd Quarter, 2005 financial statements

Friday, August 26, 2005 - Vancouver, British Columbia - Protox Therapeutics Inc. announced today the release of its second quarter financial statements for the period ending June 30, 2005.

"Several important scientific and corporate milestones were achieved during the second quarter of 2005," stated Fahar Merchant, PhD, President and CEO of the Company. "Our primary goal for 2005 is to progress PORxin™ 302 (formerly known as PSA-PAH1) into Phase I clinical trials for localized prostate cancer. We are working closely with several U.S. clinical sites to ensure that we can commence patient enrollment for the Phase I clinical trial once our upcoming Investigational New Drug (IND) filing with the U.S. Food and Drug Administration (FDA) is approved."

Operational highlights:

  • The Company reported completion of a set of animal studies at Johns Hopkins Kimmel Cancer Center. The results confirmed that engineered proaerolysin (PORxin™) preferentially killed prostate cancer cells, significantly reduced tumour volume, showed no signs of toxicity and a substantially decreased blood PSA levels, a key marker used to determine response of prostate cancer to therapy. These results were presented at the prestigious American Association of Cancer Research (AACR) meeting on April 20, 2005.
  • The Company continued with additional non-clinical studies in rodent and non-rodent species in order to support the IND application for PORxin™302.
  • The Company commenced cGMP compliant manufacturing and related CMC activities for PORxin™302 for first in man studies.
  • The Company entered into a Licence Agreement with the National Research Council Institute of Biological Sciences (NRC-IBS) and the University of Victoria (UVic) Innovation and Development Corporation (IDC) for exclusive worldwide rights to commercialize antibody targeted PORxin™ for the treatment of non-small cell lung cancer (NSCLC), which comprises 80% of all lung cancers.
  • The Company announced that it has received a financial contribution of up to $340,000 from the National Research Council Industrial Research Assistance Program (IRAP) to support the development of PORxin™ antibody fusion constructs (formerly known as Lung-H1), a targeted approach for the treatment of NSCLC.
  • The Company filed a provisional patent application with the United States Patent and Trademark Office to protect the use of its PORxin™ technology platform for the treatment of benign prostatic hyperplasia (BPH), more commonly known as prostate enlargement.
  • Dr. Fahar Merchant, was promoted to the position of President and Chief Executive Officer, replacing Tazdin Esmail, who stepped down for health reasons.
  • Leonard Cox, CA (formerly VP Finance at Xenon Pharmaceuticals) was appointed as Chief Financial Officer and Vice President, Operations.
  • Kevin McDuffie (formerly Senior Manager of Business Development at Inex Pharmaceuticals) was appointed Vice President, Business Development.

Financial Statements

The financial results of the Company include the consolidation of Protox Pharmaceuticals effective as of July 9, 2004.

Net Income

The Company incurred a net loss of $1,548,762 (or $0.07 per share) for the quarter ended June 30, 2005 and a net loss of $2,531,675 (or $0.11 per share) for the six months ended June 30, 2005. This is compared with a net loss of $428,924 (or $0.03 per share) and $774,085 (or $0.07 per share) for the quarter and six months ended June 30, 2004 respectively (Protox Pharma). 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 June 30, 2005, the Company incurred expenses related to research and development of $1,059,632. This is an increase in research and development expenses compared to the quarter ended June 30, 2004 where these expenses were $234,809. For the six months ended June 30, 2005 these expenses were $1,784,426 compared to the six months ended June 30, 2004 where these expenses were $450,012. The increase in expenditure is directly related to the formal pre-clinical studies, manufacturing costs and regulatory consultants for the PORxin™302 project. The IND for PORxin™302 is expected to be filed in Q4 2005.

General and Administrative

The Company incurred general and administrative expenses of $484,747 for the quarter ended June 30, 2005 compared with $200,070 for the quarter ended June 30, 2004 (Protox Pharma). For the six months ended June 30, 2005 the Company incurred $747,503 in general and administrative expenses compared with $336,366 for the six months ended June 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 June 30, 2005, the Company recorded $16,182 in interest income compared with $6,427 for the quarter ended June 30, 2004. During the six months ended June 30, 2005, the Company recorded $38,360 in interest income compared with $13,158 for the six months ended June 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

2nd Quarter 2005

The Company does not anticipate earning any revenue in the foreseeable future, other than interest revenue earned on its cash balances. In addition, expenses are expected to increase over the coming quarters due to increases in research and development expenses and general and administrative expenses.

Liquidity

As at June 30, 2005, the Company had cash and cash equivalents of $2,624,298. The Company anticipates that it will have sufficient funds to operate its business for approximately the next six months based on its current business plan.

Company financials for the quarter ended June 30, 2005 and Management's Discussion and Analysis will be available at www.sedar.com

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

What's New

November 24, 2008
Protox Announces Positive Phase 2 BPH Results

November 13, 2008
Protox Reports 2008 Third Quarter Results

November 5, 2008
Protox Announces Amendments To Certain Outstanding Warrants

October 8, 2008
Protox Announces Positive 12 Month Data From BPH Study

Events

PRX302 Phase 2 BPH Data Webcast
When: November 24, 5:00 p.m. ET
Webcast link

 

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