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Bradmer announces 2008 fourth quarter and fiscal year operational and financial results

Posted on: Tuesday, 31 March 2009, 15:30 CDT

TSX: BMR

TORONTO, March 31 /PRNewswire-FirstCall/ - Bradmer Pharmaceuticals Inc. ("Bradmer" or the "Corporation") announced its 2008 fourth quarter and fiscal year operational and financial results.

Operational Highlights

During the year ended December 31, 2008, the Company achieved the following steps for its multi-center Phase III trial of its lead drug Neuradiab(R), a treatment for glioblastoma multiforme (GBM), the most advanced form of brain cancer:

- Prepared and submitted the Company's drug manufacturing data package and clinical dossiers to the FDA; - Initiated enrollment in the Phase III GLASS-ART clinical trial; - Signed contracts with and activated an initial cohort of five U.S. clinical trial sites; - Successfully released a second GMP drug substance batch for use in clinical trials and filed the related update with the FDA; - Submitted new data from the previous 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 GBM (Reardon et al.; 2008 Neuro-Oncology 10:845); and - Sourced and validated commercial supplies of iodine-131 outside of the U.S. and Europe to prevent delays in raw material supply.

Subsequent to the financial year ended December 31, 2008, the Company commenced a strategic review of its operations, as more particularly described in press releases of the Company dated February 17, 2009 and March 5, 2009. Pursuant to the strategic review, the Company has closed its Phase III GLASS ART Trial to further patient enrollment due to unforeseen delays in site initiation and recruitment, the delayed ability to complete the 60 patient "run-in phase" in a timely manner, and the inability to raise further capital at this time.

The Company has been, and is continuing to evaluate strategic options.

"We have successfully transitioned Neuradiab from a Phase II compound with compelling results at a single site to a cGMP manufactured compound in a multi-center Phase III trial under a rigorous protocol. We focused specifically on reducing risk in the critical areas of manufacturing, regulatory and clinical operations," said Alan M. Ezrin, Ph.D., President and Chief Executive Officer of Bradmer. "We have initiated enrollment of patients across multiple sites and demonstrated those sites are adhering to the protocol as designed. However, the delay we have experienced in the 60-patient run-in phase has placed significant pressure on our capital resources which necessitated the strategic review by the Board."

Financial Results

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

For the year ended December 31, 2008, Bradmer recorded a net loss of $11,529,000 or $0.85 per common share, compared to a net loss of $9,436,000 or $0.87 per common share for the year ended December 31, 2007. The increased loss in 2008 was primarily related to planned research and development spending with regard to the Corporation's lead clinical program, Neuradiab, in preparation for the Phase III clinical trial, as well as the growth in Bradmer's administrative functions in anticipation of the clinical trial launch.

Research and development expenses totaled $8,327,000 in fiscal 2008, compared to $7,256,000 in fiscal 2007. The increase was primarily due to increased compensation costs for the larger clinical staff amounting for $1,004,000 compared to $311,000 for 2007. The expenses incurred in 2008 for drug manufacturing contracts amounted to $3,351,000 compared to $3,970,000 in 2007. Amounts expensed to clinical research organizations were $2,350,000 in 2008, compared to $2,620,000 in 2007. During 2007, Bradmer manufactured drug product and conducted considerable analytical work to prepare for the start of the clinical trial.

General and administrative expenses were $3,389,000 in 2008 compared to $2,796,000 in the prior year as a result of the recruitment of senior executives and additional administrative support. Compensation costs amounted to $1,237,000 in 2008 compared to $1,101,000 in 2007. The portion of stock-based compensation, a noncash item, included in general and administrative expenses was $320,000 for the year, as compared to $324,000 for 2007. The remaining $124,000 of stock-based compensation is included in research and development expenses compared to $24,000 in 2007. Recruitment fees of $210,000 were incurred to retain clinical and manufacturing staff, compared to $101,000 in 2007.

Interest income was $273,000 during fiscal 2008 compared to $577,000 in 2007, due to lower cash balances and significantly lower interest rates.

For the three-month period ended December 31, 2008, Bradmer recorded a net loss of $2,327,000, or $0.17 per common share. This compares to a net loss of $3,517,000, or $0.26 per common share for the three months ended December 31, 2007. During the fourth quarter of 2008, the Corporation focused on cost reduction opportunities in all areas of the business in response to the credit crisis and the downtown in the economy.

Research and development expenses for the fourth quarter of 2008 were $1,586,000, compared to $2,826,000 in the same period of 2007. The decrease was primarily due to reduced support costs from our clinical research organization (CRO), for our Phase III clinical development program. The expenses incurred in 2008 consisted primarily of CRO costs of $354,000 and drug manufacturing and related analytical costs of $685,000.

General and administrative expenses were $761,000 in the fourth quarter of 2008, compared to $873,000 in 2007. The portion of stock-based compensation, a noncash item, included in general and administrative expenses was $28,000 for the quarter, compared to $96,000 in the same period in 2007. The remaining $21,000 of stock-based compensation is included in research and development expenses.

Interest income was $45,000 for the fourth quarter compared to $174,000 in the same period of 2007. The reduction was due to lower cash balances in 2008 and the significant decline in interest rates over the past year.

As at December 31, 2008, Bradmer had available cash and cash equivalents of $8,245,000 as compared to $19,469,000 as at December 31, 2007. The decrease in cash was due to funds spent on production of Neuradiab, on site initiation and patient enrollment. The Company expects that cash on hand at December 31, 2008 will be sufficient to fund the wind down of operations through 2009. We will be reducing funding to the minimum level consistent with our obligations to continue to monitor the progress and safety of the patients enrolled in the trial.

As at December 31, 2008, there were 13,488,215 common shares issued and outstanding.

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

About Bradmer Pharmaceuticals Inc. (www.bradmerpharma.com)

Bradmer Pharmaceuticals' 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. Bradmer has initiated enrollment of primary GBM patients in a Phase III multi-center clinical trial of Neuradiab. 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 risk and uncertainties, which may cause 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.

Financial results are included below: Bradmer Pharmaceuticals Inc. Balance Sheets US $ December 31, December 31, 2008 2007 ------------ ------------ Assets Current Cash and cash equivalents $ 8,245,455 $19,469,337 Amounts receivable 12,520 143,722 Prepaid expenses and other assets 27,158 24,029 ------------ ------------ 8,285,133 19,637,088 Patent rights 711,054 685,165 ------------ ------------ $ 8,996,187 $20,322,253 ------------ ------------ ------------ ------------ Liabilities Current Accounts payable and accrued liabilities $ 1,594,578 $ 1,835,492 ------------ ------------ Shareholders' Equity Capital stock 31,026,728 31,026,728 Warrants 881,488 881,488 Contributed surplus 1,158,886 714,981 Deficit (25,665,493) (14,136,436) ------------ ------------ 7,401,609 18,486,761 ------------ ------------ $ 8,996,187 $20,322,253 -------------------------- -------------------------- Bradmer Pharmaceuticals Inc. Statements of Operations and Deficit US $ Three Months Three Months Ended Ended Year Ended Year Ended December 31, December 31, December 31, December 31, 2008 2007 2008 2007 ------------- ------------- ------------- ------------- Expenses Research & development $ 1,585,762 $ 2,826,417 $ 8,326,958 $ 7,255,600 General & administrative 760,608 872,750 3,389,453 2,795,860 Amortization of patent rights 16,022 14,500 61,571 51,769 Foreign exchange loss/(gain) 9,920 (22,474) 24,352 (90,399) ------------- ------------- ------------- ------------- 2,372,312 3,691,193 11,802,334 10,012,830 Interest income 45,178 174,163 273,277 577,235 ------------- ------------- ------------- ------------- Net loss (2,327,134) (3,517,030) $(11,529,057) (9,435,595) Deficit at beginning of period $(23,338,359) (10,619,406) (14,136,436) (4,700,841) ------------- ------------- ------------- ------------- Deficit at end of period $(25,665,493) $(14,136,437) $(25,665,493) (14,136,436) ------------- ------------- ------------- ------------- ------------- ------------- ------------- ------------- Basic and diluted net loss per share $ (0.17) $ (0.26) $ (0.85) $ (0.87) ------------- ------------- ------------- ------------- ------------- ------------- ------------- ------------- Weighted average number of shares 13,488,215 13,515,172 13,488,215 $10,827,882 ------------- ------------- ------------- ------------- ------------- ------------- ------------- ------------- Bradmer Pharmaceuticals Inc. Statements of Cash Flows US $ Three Months Three Months Ended Ended Year Ended Year Ended December 31, December 31, December 31, December 31, 2008 2007 2008 2007 ------------- ------------- ------------- ------------- Cash flows from operating activities Net loss for the period $ (2,327,134) $ (3,517,030) $(11,529,057) $ (9,435,595) Add items not affecting cash Amortization of patents 16,022 14,500 61,571 51,769 Stock-based compensation 49,338 37,495 443,905 348,412 ------------- ------------- ------------- ------------- $ (2,261,774) (3,465,035) (11,023,581) (9,035,414) Changes in non-cash working capital items Amounts receivable (7,961) 12,692 131,202 (66,637) Prepaid expenses and other assets 19,210 24,960 (3,129) (13,397) Accounts payable and accrued liabilities (731,553) 1,147,681 (240,914) 451,125 ------------- ------------- ------------- ------------- (2,982,078) (2,279,702) (11,136,422) (8,664,323) ------------- ------------- ------------- ------------- Cash flows from investing activities Investment in patent rights (19,374) (50,709) (87,460) (267,117) Purchase of short-term investment - - (10,000,000) - Redemption of short-term Investment - - 10,000,000 - ------------- ------------- ------------- ------------- (19,374) (50,709) (87,460) (267,117) ------------- ------------- ------------- ------------- Cash flows from financing activities Issuance of capital stock, net of share issue costs - - - 19,588,150 Repurchase of shares from employee - (800) - (800) ------------- ------------- ------------- ------------- - (800) - 19,587,350 ------------- ------------- ------------- ------------- Increase/(decrease) in cash during the period (3,001,452) (2,331,211) (11,223,882) 10,655,910 Cash and cash equivalents at beginning of period 11,246,907 21,800,548 19,469,337 8,813,427 ------------- ------------- ------------- ------------- Cash and cash equivalents at end of period $ 8,245,455 $ 19,469,337 $ 8,245,455 $ 19,469,337 ------------- ------------- ------------- ------------- ------------- ------------- ------------- -------------

SOURCE Bradmer Pharmaceuticals Inc.

Source: PR Newswire

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