TORONTO, Aug. 8 /PRNewswire-FirstCall/ - Bradmer Pharmaceuticals Inc., a clinical oncology company specializing in the development and commercialization of cancer therapies, today announced its 2007 second quarter operational and financial results.
Operational Highlights and Outlook
During the three-month period ended June 30, 2007, the Company advanced its preparations for the proposed multi-center Phase III trial of its lead drug, Neuradiab, a treatment for newly diagnosed glioblastoma multiforme (GBM). The Company is working with more than 30 of the leading GBM treatment centers in the U.S. which have provided indications of interest for participation in the proposed trial.
Bradmer is currently in consultation with the United States Food & Drug Administration (FDA) to obtain permission to initiate a multi-center Phase III trial for the adjuvant use of Neuradiab in the management of GBM. Subject to the receipt of regulatory approvals, the Company intends to implement a randomized, two-arm multi-center study with more than 300 patients in each arm comparing the survival of patients that receive the current standard of care to the standard of care in combination with Neuradiab. Assuming the receipt of requisite regulatory approvals, Bradmer plans to initiate this trial in late 2007.
“With the successful completion of our recent financing we are well positioned from a capital perspective to execute our clinical plans to conduct a landmark trial in the treatment of brain cancer. The pending confirmatory trial is one of the largest and most important GBM trials ever proposed, and we are proceeding with care under the guidance of industry-leading experts,” said Dr. Alan M. Ezrin, Chief Executive Officer of Bradmer. “We will continue the evaluation of Neuradiab for the treatment of newly diagnosed GBM in a rigorous clinical setting. The drug’s molecular target, tenascin, is virtually omnipresent in GBM cell populations and is linked closely with their proliferation. Due to these characteristics, experts have hypothesized that the targeted delivery of I-131 via Neuradiab could be a beneficial therapy for the broad GBM population.”
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 June 30, 2007, Bradmer recorded a net loss of $1,781,359, or $0.21 per common share, compared with a net loss of $670,671 or $0.09 per common share for the three-month period ended June 30, 2006. For the six-month period ended June 30, 2007, Bradmer recorded a net loss of $3,634,856, or $0.45 per common share compared with a net loss of $1,289,102, or $0.17 per common share for the six-month period ended June 30, 2006. The increased losses during the 2007 periods were primarily related to higher planned research and development spending with regard to the Company’s lead clinical program, Neuradiab.
Research and development expenses totaled $1,092,549 and $2,365,469, respectively, for the three- and six-month periods ended June 30, 2007, compared with $323,300 and $658,810 for the corresponding periods in 2006. Research and development expenses incurred in 2007 were primarily related to amounts paid under drug manufacturing contracts, as well as amounts paid to clinical and regulatory collaborators.
Management wage expenses, including payroll taxes, of $291,166 and $537,220 were recorded during the respective three- and six-month periods ended June 30, 2007 in accordance with employment contracts compared with management wage expenses of $155,097 and $305,765 for the corresponding periods in 2006. Current year management wages were higher due primarily to an expanded team.
Travel related expenses totaled $139,264 and $260,666, respectively, for the three- and six-month periods ended June 30, 2007, compared with $68,234 and $85,549 for the respective prior year periods. The higher travel expenses incurred in 2007 were primarily related to intensified team efforts with regard to clinical development, manufacturing and investor relations.
Office and administrative expenses of $108,248 and $239,254 during the respective three- and six-month periods ended June 30, 2007 included charges relating to, among other things, facilities, administrative staffing, communications, investor relations and insurance. Office and administrative expenses for the corresponding periods in 2006 totaled $78,713 and $146,999, respectively. Additionally, professional fee expenses of $110,743 and $183,019, respectively, were incurred during the three- and six-month periods ended June 30, 2007, compared with $133,693 and $151,664 incurred during the corresponding periods in 2006.
Non-cash stock-based compensation charges totaled $106,026 and $189,703 for the three- and six-month periods ended June 30, 2007, resulting from the issuance of employee options. Such stock-based compensation charges totaled $8,733 and $88,786 in the comparative periods ended June 30, 2006.
Operational expenses were offset by interest income earned on short-term investments of $78,428 and $163,919, respectively, during the three- and six-month periods ended June 30, 2007, as compared with $115,351 and $166,723 for the comparative prior year three- and six-month periods.
As at June 30, 2007, Bradmer had available cash and cash equivalents of $24,197,265 compared with $8,813,427 at December 31, 2006. The increase was related to proceeds of the public offering closed on June 22, 2007, which yielded gross proceeds of Cdn$23.1 million. After deducting cash-based share issue costs and converting to US dollars, net proceeds totaled $19.6 million. It is anticipated that cash on hand at June 30, 2007 will be sufficient to fund Company operations at least through 2009, inclusive of clinical trial costs and infrastructure costs during such period.
As at June 30, 2007, there were 13,568,215 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.
Neuradiab Treatment
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. Approximately 200 brain cancer patients, including over 160 with GBM, have been treated with Neuradiab, and survival benefits have significantly exceeded historical controls in each completed trial.
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 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. (www.bradmerpharma.com)
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 in the process of organizing a pivotal multi-center clinical trial of the licensed treatment. 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.
Bradmer Pharmaceuticals Inc. Balance Sheets (Expressed in United States Dollars) (unaudited) ------------------------------------------------------------------------- June 30 December 31 2007 2006 ------------------------------------------------------------------------- (audited) Assets Current Cash $ 24,197,265 $ 8,813,427 Amounts receivable 116,504 77,085 Prepaid expenses 45,587 10,632 ------------------------------------------------------------------------- 24,359,356 8,901,144 Patent rights 552,015 469,817 ------------------------------------------------------------------------- $ 24,911,371 $ 9,370,961 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Liabilities Current Accounts payable and accrued liabilities $ 781,780 $ 1,384,367 ------------------------------------------------------------------------- Shareholders’ Equity Capital stock 31,210,728 12,504,066 Contributed surplus 373,072 183,369 Warrants 881,488 - Deficit (8,335,697) (4,700,841) ------------------------------------------------------------------------- 24,129,591 7,986,594 ------------------------------------------------------------------------- $ 24,911,371 $ 9,370,961 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Bradmer Pharmaceuticals Inc. Interim Statements of Operations and Deficit (Expressed in United States Dollars) (unaudited) ------------------------------------------------------------------------- Six Months Ended Three Months Ended June 30 June 30 2007 2006 2007 2006 ------------------------------------------------------------------------- Expenses Stock based compensation 189,703 88,786 106,026 8,733 Management fees 537,220 305,765 291,166 155,097 Professional fees 183,019 151,664 110,743 133,693 Office and administrative 239,254 146,999 108,248 78,713 Research expenses 2,365,469 658,810 1,092,549 323,300 Travel 260,666 85,549 139,264 68,234 Amortization of patents 23,444 18,252 11,791 18,252 ------------------------------------------------------------------------- 3,798,775 1,455,825 1,859,787 786,022 Interest income 163,919 166,723 78,428 115,351 ------------------------------------------------------------------------- Net loss (3,634,856) (1,289,102) (1,781,359) (670,671) Deficit at beginning of period (4,700,841) (255,223) (6,554,338) (873,654) ------------------------------------------------------------------------- Deficit at end of period $(8,335,697) $(1,544,325) $(8,335,697) $(1,544,325) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Basic and diluted loss per share $ (0.45) $ (0.17) $ (0.21) $ (0.09) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Weighted average number of shares 8,069,091 7,780,816 8,353,674 7,781,026 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Bradmer Pharmaceuticals Inc. Interim Statements of Cash Flows (Expressed in United States Dollars) (unaudited) ------------------------------------------------------------------------- Six Months Ended Three Months Ended June 30 June 30 2007 2006 2007 2006 ------------------------------------------------------------------------- Cash flows from operating activities Net loss for the period $(3,634,856) $(1,289,102) $(1,781,359) $ (670,671) Add items not affecting cash Amortization of patents 23,444 18,252 11,791 18,252 Stock-based compensation 189,703 88,786 106,026 8,733 ------------------------------------------------------------------------- (3,421,709) (1,182,064) (1,663,542) (643,686) Changes in non- cash working capital items Amounts receivable (39,419) (45,305) (40,107) (35,480) Prepaid expenses (34,955) (40,203) 15,778 16,717 Accounts payable and accrued liabilities (602,587) (404,853) 159,028 (86,534) ------------------------------------------------------------------------- (4,098,670) (1,672,425) (1,528,843) (748,983) ------------------------------------------------------------------------- Cash flows from investing activities Investment in patent rights (105,642) (258,494) (6,998) 15,829 ----------------------------------------------------------------------- Cash flows from financing activities Repayment of due to related party - (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 19,588,150 12,086,713 19,588,150 - Issuance of capital stock upon exercise of warrants - 2,414 - 2,414 ------------------------------------------------------------------------- 19,588,150 12,257,322 19,588,150 2,414 ------------------------------------------------------------------------- Increase (decrease) in cash during the period 15,383,838 10,326,403 18,052,309 (730,740) Cash at beginning of period 8,813,427 262,723 6,144,956 11,319,866 ------------------------------------------------------------------------- Cash at end of period $24,197,265 $10,589,126 $24,197,265 $10,589,126 ------------------------------------------------------------------------- -------------------------------------------------------------------------
Bradmer Pharmaceuticals Inc.
CONTACT: Bradmer Pharmaceuticals Inc., Mr. Brian Brohman, Chief Businessand Financial Officer, Phone: (416) 361-6058 (Ext. 804), E-mail:bbrohman@bradmerpharma.com, Internet: www.bradmerpharma.com; InvestorRelations, Ross Marshall, The Equicom Group Inc., Phone: (416) 815-0700(Ext. 238), Fax: (416) 815-0080, E-mail: rmarshall@equicomgroup.com
