TORONTO, Aug. 10 /PRNewswire-FirstCall/ - Bradmer Pharmaceuticals Inc., a biotechnology company dedicated to the development and commercialization of cancer therapies, today announced its 2006 second quarter operational and financial results.
Second Quarter Highlights - Signed a three-year contract with MDS Nordion for the formulation development and clinical trial supply of Neuradiab in preparation for the planned multi-center clinical trial. - The European Patent Office issued a letter of allowance to the Company’s license partner Duke University for a patent titled “Radioconjugation of Internalizing Antibodies”. - Received approval and began trading on the TSX under the symbol BMR after initially trading on the TSX Venture Exchange.
“We continue to focus our resources on preparations for the planned multi-center clinical trial of our late-stage drug for brain cancer, Neuradiab. We are proceeding as anticipated on multiple fronts, including cGMP drug manufacturing, regulatory preparation, site selection, and service provider contracting,” said Mark C. Rogers, M.D., Chief Executive Officer of Bradmer. “We intend to meet with the U.S. Food and Drug Administration later this year to discuss the structure of the trial, including its design and clinical endpoints, prior to its initiation in early 2007. We believe that Neuradiab’s unique mechanism of action and its high specificity for tenascin, a target present in virtually all GBM cases, provide a significant potential for it to be an effective adjunct therapy for newly diagnosed glioblastoma multiforme (“GBM”).”
Financial Highlights (amounts in US Dollars, unless specified)
Research and development expenses for the three-month and six-month periods ended June 30, 2006 were $323,300 and $658,810, which related primarily to drug manufacturing contracts as well as amounts paid to clinical and regulatory advisors.
Management wage expenses, including payroll taxes, for the three-month and six-month periods ended June 30, 2006 were $155,097 and $305,765.
Office and administrative expenses for the three-month and six-month periods ended June 30, 2006 were $194,214 and $276,625 respectively, which included charges related to facilities, communications, travel, investor relations and insurance. Professional fee expenses for the three-month and six-month periods ended June 30, 2006 were $133,693 and $151,664 respectively, and consisted primarily of legal and accounting costs.
The non-cash stock-based compensation charges for the three-month and six-month periods ended June 30, 2006 totaled $8,733 and $88,786 respectively as a result of the issuance of options.
Operational expenses were offset in part by interest income of $115,351 and $166,723 during the three-month and six-month periods ended June 30, 2006.
The Company recorded a net loss for the three-month and six-month periods ended June 30, 2006 of $670,671 or ($0.09 per share) and $1,289,102 or ($0.17 per share) respectively.
As at June 30, 2006, Bradmer had available cash and cash equivalents of $10,589,126 as compared with $262,723 as at December 31, 2005. The Company expects that cash on hand at June 30, 2006 will be sufficient to fund operations into early 2008, inclusive of clinical trial costs and infrastructure costs during such period.
Operational activities for the period ended June 30, 2006 were financed by the proceeds of separate pre-amalgamation financing events. 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.
As at June 30, 2006, there were 7,781,344 common shares issued and outstanding.
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 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 (US Orphan Drug designation already obtained) - 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 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, patients treated with Neuradiab, delivered in combination with the current standard therapy, demonstrated a median survival of 91 weeks, an appreciable increase over published historical controls for newly diagnosed GBM cases.
Each year, up to 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. (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 has been 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.
Interim Balance Sheets (Expressed in United States Dollars) (unaudited) ------------------------------------------------------------------------- June 30, December 31, 2006 2005 ------------------------------------------------------------------------- (audited) Assets Current Cash and cash equivalents $ 10,589,126 $ 262,723 Amounts receivable 69,694 - Prepaid expenses 40,203 - ------------------------------------------------------------------------- 10,699,023 262,723 Patent rights, net of accumulated amortization of $18,252 (2005 - $NIL) 457,390 217,148 Deferred share issuance costs - 60,469 ------------------------------------------------------------------------- $ 11,156,413 $ 540,340 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Liabilities Current Accounts payable and accrued liabilities $ 107,886 $ 389,427 Due to related parties - 401,210 ------------------------------------------------------------------------- 107,886 790,637 ------------------------------------------------------------------------- Shareholders’ Equity Capital stock 12,504,066 3,366 Contributed surplus 88,786 1,560 Deficit (1,544,325) (255,223) ------------------------------------------------------------------------- 11,048,527 (250,297) ------------------------------------------------------------------------- $ 11,156,413 $ 540,340 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Approved by “Mark C. Rogers” Director “Peter Roberts” Director the Board ------------------ ----------------- (Signed) (Signed) Interim Statement of Operations and Deficit For the Six and Three Month Periods Ended June 30, 2006 (Expressed in United States Dollars) (unaudited) ------------------------------------------------------------------------- Six Months Three Months Ended Ended ------------------------------------------------------------------------- Expenses Stock-based compensation $ 88,786 8,733 Management wages 305,765 155,097 Professional fees 151,664 133,693 Office and administrative 276,625 194,214 Research expenses 658,810 323,300 Interest 3,190 - Foreign exchange gain (47,267) (47,267) Amortization of patents 18,252 18,252 ------------------------------------------------------------------------- 1,455,825 786,022 Interest income 166,723 115,351 ------------------------------------------------------------------------- Net loss (1,289,102) (670,671) Deficit at beginning of period (255,223) (873,654) ------------------------------------------------------------------------- Deficit at end of period $ (1,544,325) $ (1,544,325) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Basic and diluted loss per share $ (0.17) $ (0.09) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Weighted average number of shares outstanding 7,780,816 7,781,026 Interim Statement of Cash Flows For the Six and Three Month Periods Ended June 30, 2006 (Expressed in United States Dollars) (unaudited) ------------------------------------------------------------------------- Six Months Three Months Ended Ended ------------------------------------------------------------------------- Cash flows from operating activities Net loss for the period $ (1,289,102) $ (670,671) Add item not affecting cash Amortization 18,252 18,252 Stock-based compensation 88,786 8,733 ------------------------------------------------------------------------- (1,182,064) (643,686) Changes in non-cash working capital items Amounts receivable (45,305) (35,480) Prepaid expenses (40,203) 16,717 Accounts payable and accrued liabilities (404,853) (86,534) ------------------------------------------------------------------------- (1,672,425) (748,983) ------------------------------------------------------------------------- Cash flows from investing activity Investment in patent rights (258,494) 15,829 ------------------------------------------------------------------------- Cash flows from financing activities Repayment of amounts 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 - Issuance of capital stock upon exercise of warrants 2,414 2,414 ------------------------------------------------------------------------- 12,257,322 2,414 ------------------------------------------------------------------------- Increase (decrease) in cash during the period 10,326,403 (730,740) Cash and cash equivalents at beginning of period 262,723 11,319,866 ------------------------------------------- Cash and cash equivalents at end of period $ 10,589,126 $ 10,589,126 ------------------------------------------- -------------------------------------------
Bradmer Pharmaceuticals Inc.
CONTACT: Bradmer Pharmaceuticals Inc., Mr. Brian Brohman, Chief FinancialOfficer, Phone: (502) 657-6038, Fax: (502) 657-6039, 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
