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Bradmer announces 2008 third quarter operational and financial results


TORONTO, Nov. 10 /PRNewswire-FirstCall/ - Bradmer Pharmaceuticals Inc., a clinical oncology company specializing in the development and commercialization of cancer therapies, today announced its 2008 third quarter operational and financial results.

Operational Highlights

During the three months ended September 30, 2008 and the period subsequent to this date, the Company achieved the following milestones related to its operations and its lead drug, Neuradiab(TM), which is being studied in the Phase III GLASS-ART(TM) Trial:

- Maintained budgetary control and reduced quarterly spending;

- Signed clinical study contracts with nine of the initial 16 sites

under active consideration and activated an initial cohort of five

sites, while advancing a pipeline of additional sites in the US

through the contractual, training and regulatory process;

- Initiated dialog with Health Canada for study expansion into key

Canadian sites with the support of the Canadian Brain Cancer


- Enrolled the first group of patients in the GLASS-ART Trial and

successfully dosed patients with Neuradiab at multiple sites;

- Announced new data from the most recent Phase II trial indicating that

the mean time to progression free survival was 77 weeks, which

compares favorably with other published results in newly diagnosed


- Evaluated a series of technical steps that may allow a two week

extension of the shelf life of Neuradiab beyond the current six-day

specification; and

- Appointed Dr. Donald Kufe, Professor of Medicine, Harvard Medical

School and Director, Experimental Therapeutics Program, Dana-

Farber/Harvard Cancer Center and Charles James Lilly, CA, a senior

partner with a public accounting firm, to the Board of Directors of

the Company.

"The treatment of the initial patients in the Phase III trial of Neuradiab represents a major accomplishment in that we have demonstrated the technical feasibility of taking our Duke-developed drug for GBM to a multi-center trial," said Alan M. Ezrin, Ph.D., President and Chief Executive Officer of Bradmer. "During these difficult economic times our burn-rate has reflected the control we have exhibited over our resources and the focus and execution we have for the GLASS-ART Trial. The significant expense of setting up the trial is behind us and we have developed agreements with our key vendors that are largely tied to the pace of enrollment and milestones achieved. Now that patient enrollment is ongoing at the initial sites, we continue to expand the active sites with more than 30 centers projected to complete the process of qualification, training and initiation in the coming months. The run-in phase of the study targeting the enrollment of 60 patients is proceeding well with no serious limitations or issues. We look forward to our initial submission to the Drug Safety Monitoring Board and the Food and Drug Administration to report protocol compliance. Successful execution of the run-in phase will demonstrate to potential partners that the trial is appropriately designed and is being conducted in a manner that is likely to provide a definitive answer on the benefit of Neuradiab in the newly diagnosed GBM population."

The Phase III trial will investigate Neuradiab as an adjuvant therapy to the current standard of care which consists of surgery, external beam radiation and temozolomide. The randomized trial is designed to enroll 760 patients with newly diagnosed GBM.

Financial Highlights

Amounts in US dollars, unless specified otherwise, and results expressed in accordance with Canadian Generally Accepted Accounting Principles (Canadian GAAP).

For the three-month period ended September 30, 2008, the Company recorded a net loss of $2,627,000, or $0.19 per share, based on the weighted average outstanding shares of 13,488,215. This compares to a net loss of $2,284,000, or $0.17 per share for the three-month period ended September 30, 2007, based on the weighted average outstanding shares of 13,568,215. For the nine-month period ended September 30, 2008, the Company recorded a net loss of $9,202,000, or $0.68 per share, based on the weighted average outstanding shares of 13,488,215. This compares to a net loss of $5,919,000, or $0.60 per share for the nine-month period ended September 30, 2007, based on the weighted average outstanding shares of 9,922,276. The change in net loss related to planned research and development spending with regard to the Company's lead clinical program, Neuradiab, as it enrolled the first patients in the clinical trial, as well as to the growth in the Company's administrative functions in anticipation of the clinical trial launch.

Research and development expenses for the third quarter of 2008 were $1,908,000, an increase of $150,000 from $1,758,000 in the same period of 2007. The increase was primarily due to increased support costs from the Company's clinical research organization (CRO), ICON Clinical Research, for the Phase III clinical development program. The expenses incurred in 2008 were primarily related to drug manufacturing contracts of $231,000, as well as amounts expensed to clinical research organizations of $745,000. During the period, Bradmer expanded drug manufacturing analytical support and secured the agreement of a cohort of sites to participate in the clinical trial.

General and administrative expenses were $768,000 in the third quarter of 2008, a decrease of $54,000 from $822,000 in 2007. The portion of stock-based compensation, a noncash item, included in general and administrative expenses was $84,000 for the quarter, unchanged from the same period in 2007. Interest income decreased to $69,000 for the quarter from $239,000 in the same period of 2007. The reduction was due to the lower cash balances in 2008 and the significant decline in interest rates over the past year.

As at September 30, 2008, Bradmer had available cash and cash equivalents and short-term investments totaling $11,247,000 as compared with $19,469,000 as at December 31, 2007. The decrease in cash was related to the operating costs incurred in the first nine months of the year. The Company expects that cash on hand at September 30, 2008 will be sufficient to fund operations through the next 12 months and beyond, inclusive of clinical trial and infrastructure costs during such period.

Operational activities for the three-month period ended September 30, 2008 were financed by cash on hand and the proceeds of the public offering completed in June 2007.

As at September 30, 2008, there were 13,488,215 common shares issued and outstanding.


Bradmer's operational objective is clear: execute a multi-center randomized trial evaluating Neuradiab in newly diagnosed GBM patients. During the remainder of 2008 and the first half of 2009, the Company intends to execute on the following components of its operational plan:

- Continue the activation of leading GBM treatment centers across the


- Submit the first Data Safety Monitoring Board summary to the FDA on

the initial 30 patients enrolling; and

- Complete the run-in phase for 60 patients and submit Data Safety

Monitoring Board data to the FDA.

Additional information about the Company, including the MD&A and financial results may be found on SEDAR at

About Neuradiab(TM)

Neuradiab is a monoclonal antibody, conjugated to radioactive iodine, used to treat glioblastoma multiforme (GBM), the most common and most advanced form of brain cancer. Neuradiab delivers tumor-killing radiation specifically to residual brain tumor cells after surgery, with minimal impact on normal brain tissue. During the course of development at Duke University, over US$60 million in research grants and related support has produced a series of Phase I and Phase II clinical trials on Neuradiab and other closely related technologies. Approximately 200 brain cancer patients, including over 160 with GBM, have been treated with the Neuradiab therapy regimen, and survival benefits have significantly exceeded historical controls in each completed trial. Neuradiab has been formerly referred to in literature as 131-I anti-tenascin monoclonal antibody 81c6. Bradmer Pharmaceuticals initiated a Phase III trial testing Neuradiab in newly diagnosed GBM in July 2008.

Each year up to 30,000 new cases of GBM are diagnosed in the world's seven largest healthcare markets. The current standard of care for GBM patients is surgical resection followed by radiation and temozolomide. GBM tumors typically have infiltrating edges that are very difficult to remove completely with surgery. The Neuradiab therapy is delivered directly into the surgical resection cavity in a separate procedure after the initial surgery. Neuradiab delivers a concentrated level of radiation specifically to the remaining cancer cells by targeting tenascin. Tenascin is a protein over- expressed in 99% of GBM cells but absent from normal brain cells.

About Bradmer Pharmaceuticals Inc. (

Bradmer Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of new and innovative cancer therapies. Bradmer's lead clinical candidate, Neuradiab, was developed at Duke University Medical Center as a proprietary therapy for a particularly aggressive form of brain cancer, glioblastoma multiforme. To date, over US$60 million in grants and related support has driven research and development of the licensed treatment, which has been delivered to over 200 patients with promising results and has completed Phase II clinical trials at Duke University. Bradmer is currently executing a Phase III clinical trial (the GLASS-ART Trial - investigating Neuradiab as a front line treatment in newly diagnosed GBM. Neuradiab has been granted Orphan Drug Status by both the U.S. Food and Drug Administration and the European Medicines Agency.

Bradmer Pharmaceuticals Inc.'s common shares have not been registered under the Securities Act of 1933, as amended (the "Securities Act") or any state regulatory agency in the United States. The resale or transfer by a U.S. investor of such common shares of Bradmer Pharmaceuticals Inc. is subject to the requirements of Rule 904 of Regulation S of the Securities Act or such other applicable exemption thereunder, and other applicable state securities laws.

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, the receipt of all regulatory approvals required to conduct the proposed clinical trial of Neuradiab, 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.

Financials results included below:

Bradmer Pharmaceuticals Inc.

Balance Sheets

US $

September 30, December 31,

2008 2007

------------- -------------

Assets (audited)


Cash $ 11,246,907 $ 19,469,337

Short-term investments - -

Amounts receivable 4,559 143,722

Prepaid expenses and other assets 46,368 24,029

------------- -------------

11,297,834 19,637,088

Patent rights 707,702 685,165

------------- -------------

$ 12,005,536 $ 20,322,253

------------- -------------

------------- -------------



Accounts payable and accrued

liabilities $ 2,326,131 $ 1,835,492

------------- -------------

Shareholders' Equity

Capital stock 31,026,728 31,026,728

Warrants 881,488 881,488

Contributed surplus 1,109,548 714,981

Deficit (23,338,359) (14,136,436)

------------- -------------

9,679,405 18,486,761

------------- -------------

$ 12,005,536 $ 20,322,253


Statements of Operations and Deficit

US $

Three Months Three Months Nine Months Nine Months

Ended Ended Ended Ended

September 30, September 30, September 30, September 30,

2008 2007 2008 2007

------------- ------------- ------------- -------------


Research &

development $ 1,908,153 $ 1,757,884 $ 6,741,195 $ 4,429,183

General &

administration 768,454 821,676 2,628,846 1,936,821

Amortization of

patent rights 15,747 13,825 45,549 37,269


exchange loss 3,032 (70,523) 14,432 (81,636)

------------- ------------- ------------- -------------

2,695,386 2,522,862 9,430,022 6,321,637

Interest income 68,725 239,153 228,099 403,072

------------- ------------- ------------- -------------

Net loss (2,626,661) (2,283,709) (9,201,923) (5,918,565)

Deficit at


of period (20,711,698) (8,335,697) (14,136,436) (4,700,841)

------------- ------------- ------------- -------------

Deficit at end

of period $(23,338,359) $(10,619,406) $(23,338,359) $(10,619,406)

--------------------------- ------------- -------------

--------------------------- ------------- -------------

Basic and

diluted net

loss per share $ (0.19) $ (0.17) $ (0.68) $ (0.60)

--------------------------- ------------- -------------

--------------------------- ------------- -------------

Weighted average

number of shares 13,488,215 13,568,215 13,488,215 9,922,276

Statements of Cash Flows

US $

Three Months Three Months Nine Months Nine Months

Ended Ended Ended Ended

September 30, September 30, September 30, September 30,

2008 2007 2008 2007


Cash flows from



Net loss for

the period $ (2,626,661) $ (2,283,709) $ (9,201,923) $ (5,918,565)

Add items not

affecting cash


of patents 15,747 13,825 45,549 37,269


compensation 113,253 121,214 394,567 310,917


Interest on


investment 31,944 - - -


(2,465,717) (2,148,670) (8,761,807) (5,570,379)

Changes in


working capital



receivable 13,510 (39,910) 139,163 (79,329)


expenses 5,297 (3,402) (22,339) (38,357)


payable and


liabilities 439,078 (93,969) 490,639 (696,555)


(2,007,832) (2,285,951) (8,154,344) (6,384,620)


Cash flows from



Investment in

patent rights (33,471) (110,766) (68,086) (216,409)

Purchase of


investment - - (10,000,000) -

Redemption of


Investment 10,000,000 - 10,000,000 -


9,966,529 (110,766) (68,086) (216,409)


Cash flows from



Issuance of

capital stock,

net of share

issue costs - - - 19,588,150



(decrease) in

cash during the

period 7,958,697 (2,396,717) (8,222,430) 12,987,121

Cash at beginning

of period 3,288,210 24,197,265 19,469,337 8,813,427


Cash and cash

equivalents at

end of period $ 11,246,907 $ 21,800,548 $ 11,246,907 $ 21,800,548


SOURCE Bradmer Pharmaceuticals Inc.
Copyright©2008 PR Newswire.
All rights reserved

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