TORONTO, May 12 /PRNewswire-FirstCall/ -- Bradmer Pharmaceuticals Inc., a biotechnology company dedicated to the development and commercialization of cancer therapies, today announced its operational and financial results for the three-month period ended March 31, 2006.
First Quarter Highlights
- Completed Qualifying Transaction, with Bradmer (a capital pool
company) and Blue Devil Pharmaceuticals Inc. amalgamating to form
Bradmer Pharmaceuticals Inc.
- Received approval and began trading on the TSX under the symbol BMR
subsequent to the end of the quarter, after initially trading on the
TSX Venture Exchange.
- Completed manufacturing agreements with Laureate Pharma and
MDS Nordion, for the process development and manufacture of cGMP
clinical trial quantities of the lead drug candidate, Neuradiab.
"Bradmer has successfully completed several important corporate milestones in 2006, including the amalgamation between Bradmer and Blue Devil and listing on the Toronto Stock Exchange," said Mark C. Rogers, M.D., Chief Executive Officer of Bradmer. "With the completion of these corporate events behind us, we are focused on the upcoming clinical milestones for Neuradiab. We have already signed two manufacturing and supply agreements for the clinical grade material necessary to initiate the planned multi-center clinical trial. We continue to recruit additional clinical sites to participate in the planned gliobastoma multiforme multi-center trial, and we are on target to begin the trial in late 2006 or early 2007."
Financial Highlights (amounts in US Dollars, unless specified)
Research and development expenses for the three-month period ended March 31, 2006 were $335,510, which related primarily to drug manufacturing contracts.
Management wage expenses, including payroll taxes, were $150,668 during the three-month period ended March 31, 2006.
Office and general expenses for the three-month period ended March 31, 2006 were $82,411 and included charges related to facilities, communications, travel, investor relations and insurance.
For the three-month period ended March 31, 2006, non-cash stock based compensation charges totaled $80,053 resulting from the issuance of options.
For the three-month period ended March 31, 2006 the Company recorded a net loss of $618,431 ($0.08 per share).
As at March 31, 2006, Bradmer had cash and cash equivalents of $11,319,866 as compared with $262,723 as at December 31, 2005. The Company expects these funds will be sufficient to fund product development plans and operating costs for approximately the next 24 months, inclusive of clinical trial costs and infrastructure costs during the period.
As at March 31, 2006, there were 7,780,603 common shares issued and outstanding.
Operational activities for the period ended March 31, 2006 were financed by the proceeds of separate pre-amalgamation financing events. In February 2006, prior to the amalgamation, Bradmer received gross proceeds totaling Cdn$1.0 million from the sale of its common shares by way of a June, 2005 private placement and a September, 2005 initial public offering. Net proceeds from the two Bradmer offerings, after deducting share issue costs, amounted to Cdn$875,244. Also prior to the amalgamation, Blue Devil received gross proceeds of $12,975,000 (or Cdn$15,052,000) from the sale of its common shares under concurrent brokered and non-brokered private offerings in Canada and the United States. Net proceeds from the Blue Devil offerings, after deducting share issue costs, amounted to $12,023,659.
Outlook
The Company's main priority for 2006 is the preparation of the planned multi-center clinical trial for Neuradiab which it expects to commence in late 2006 or early 2007. The upcoming milestone events expected include:
- Continued recruitment of clinical sites to participate in the planned
multi-center clinical trial
- Submission of application for European Orphan Drug designation
- Initiation of the multi-center clinical trial at the leading
glioblastoma multiforme treatment centers across the U.S.
Additional information about the Company, including the MD&A and financial results may be found on SEDAR at http://www.sedar.com/.
Neuradiab Treatment
Neuradiab is a monoclonal antibody, conjugated to radioactive iodine, used to treat glioblastoma multiforme (GBM), the most common and deadly form of brain cancer. Neuradiab delivers tumor-killing radiation specifically to residual brain tumor cells after surgery, with minimal impact on normal brain tissue. Over the course of development at Duke University, over US$60 million in research grants and related support has produced a series of seven Phase I and Phase II clinical trials. 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 and every completed trial. In a recent Phase II trial of newly diagnosed GBM patients, Neuradiab, used in combination with the current standard therapy, extended median survival by 42% to 91 weeks compared with 64 weeks for a historical control group.
Each year, an estimated 30,000 new cases of GBM are diagnosed in 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 completely remove 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. (http://www.bradmerpharma.com/)
Bradmer Pharmaceuticals is a biotechnology 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. 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 excellent results and has completed Phase II clinical trials at Duke University. Bradmer is currently in the process of organizing a multi-center clinical trial of the licensed treatment. Neuradiab was recently granted Orphan Drug Status by the U.S. Food and Drug Administration.
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.
Bradmer Pharmaceuticals Inc.
Interim Balance Sheets
(Expressed in United States Dollars)
(unaudited)
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March 31, December 31,
2006 2005
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Assets
Current
Cash and cash equivalents $ 11,319,866 $ 262,723
Amounts receivable 34,214 -
Prepaid expenses 56,920 -
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11,411,000 262,723
Patent rights 491,471 217,148
Deferred share issuance costs - 60,469
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$ 11,902,471 $ 540,340
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Liabilities
Current
Accounts payable and accrued liabilities $ 194,420 $ 389,427
Due to related parties - 401,210
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194,420 790,637
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Shareholders' Equity
Capital stock 12,501,652 3,366
Contributed surplus 80,053 1,560
Deficit (873,654) (255,223)
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11,708,051 (250,297)
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$ 11,902,471 $ 540,340
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Bradmer Pharmaceuticals Inc.
Interim Statement of Operations and Deficit
For the Three Month period ended March 31, 2006
(Expressed in United States Dollars)
(unaudited)
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2006
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Expenses
Stock-based compensation $ 80,053
Management wages 150,668
Professional fees 17,971
Office and administrative 82,411
Research expenses 335,510
Interest 3,190
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669,803
Interest income 51,372
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Net loss (618,431)
Deficit at beginning of period (255,223)
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Deficit at end of period $ (873,654)
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Basic and diluted loss per share $ (0.08)
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Weighted average number of shares outstanding 7,596,780
Bradmer Pharmaceuticals Inc.
Interim Statement of Cash Flows
For the Three Month Period Ended March 31, 2006
(Expressed in United States Dollars)
(unaudited)
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2006
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Cash flows from operating activities
Net loss for the period $ (618,431)
Add item not affecting cash:
Stock-based compensation 80,053
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(538,378)
Changes in non-cash working capital items
Amounts receivable (9,825)
Prepaid Expenses (56,920)
Accounts payable and accrued liabilities (318,319)
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(923,442)
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Cash flows from investing activity
Investment in licensed treatment (274,323)
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Cash flows from financing activities
Repayment of due to related parties (401,210)
Cash of former Bradmer upon amalgamation 563,405
Issuance of capital stock upon exercise of stock options 6,000
Issuance of capital stock, net of share issue costs 12,086,713
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12,254,908
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Increase in cash during the period 11,057,143
Cash and cash equivalents at beginning of period 262,723
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Cash and cash equivalents at end of period $ 11,319,866
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