Navigation Links
Bradmer announces 2007 fourth quarter and fiscal year operational and financial results
Date:3/12/2008

TSX: BMR

TORONTO, March 12 /PRNewswire-FirstCall/ - Bradmer Pharmaceuticals Inc., a clinical oncology company specializing in the development and commercialization of cancer therapies, today announced its 2007 fourth quarter and fiscal year operational and financial results.

Operational Highlights

During the year ended December 31, 2007, the Company achieved the following steps in preparation for the upcoming multi-center Phase III trial and subsequent planned commercialization for its lead drug Neuradiab, a treatment for glioblastoma multiforme, the most deadly form of brain cancer:

- Completed development and validation of cGMP manufacturing processes

of the Neuradiab drug substance (antibody component) and final drug

product (radiolabeled antibody).

- Conducted pre-Phase III meetings with the U.S. Food and Drug

Administration (FDA) regarding the protocol and design of the Phase

III trial as well as the drug manufacturing processes.

- Entered formal contracting and approval processes with more than 30

U.S. clinical trial sites, in line with previously stated site

recruitment goals.

- Prepared and submitted the Company's drug manufacturing data package

to the FDA, subsequent to the end of the fiscal year. The submission

is currently under review. After completion of the review and

satisfactory resolution of any further requests of the FDA, if any,

Bradmer will submit a clinical update to its Investigational New Drug

(IND) application and proceed with the launch of the planned Phase

III trial.

"We have made significant progress toward the initiation of our planned multi-center Phase III trial of Neuradiab by focusing specifically on reducing risk in the critical areas of manufacturing, regulatory and clinical operations," said Alan M. Ezrin, Ph.D,587,350 12,257,322

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

Increase

(decrease) in

cash during

the period (2,331,211) (1,334,057) 10,655,910 8,550,704

Cash at beginning

of period 21,800,548 10,147,484 8,813,427 262,723

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

Cash at end

of period $ 19,469,337 $ 8,813,427 $ 19,469,337 $ 8,813,427

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

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

., President and Chief Executive Officer of Bradmer. "We successfully initiated and completed manufacturing of the drug product at cGMP contract manufacturing facilities and we gained concurrence with the FDA as to our clinical trial design. These achievements clear the path towards the launch of the Phase III trial in the spring of 2008."

The Phase III trial will investigate Neuradiab as an adjuvant therapy to surgery, external beam radiation and temozolomide in 760 patients with newly diagnosed glioblastoma multiforme (GBM). The randomized trial is expected to be conducted at leading brain tumor treatment centers across the US.

Financial Highlights

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

The Company recorded a net loss for the three-month and twelve-month periods ended December 31, 2007 of $3,517,000 or $0.26 per share and $9,436,000 or $0.87 per share, respectively. For the three-month and twelve-month periods ended December 31, 2006, the net loss was $2,700,000 or $0.35 per share and $4,446,000 or $0.57 per share, respectively.

Research and development expenses for the three-month and twelve-month periods ended December 31, 2007 were $2,669,000 and $6,590,000 compared with $2,073,000 and $2,966,000 in the comparable periods in 2006. These expenses related primarily to drug manufacturing costs as well as amounts paid to clinical and regulatory advisors. The increase was due to increased costs associated with manufacturing and support for our Phase III clinical development program. During the fourth quarter, Bradmer expanded drug manufacturing analytical support and prepared a second GMP batch of drug substance in order to exceed expected regulatory requests and ensure initiation of the trial in 2008.

Management salaries for the three-month and twelve-month periods ended December 31, 2007 were $419,000 and $1,280,000 compared with $302,000 and $746,000 for the corresponding periods in 2006, respectively. The change in management salaries is primarily due to the hiring of additional management during 2007.

Office and administrative expenses for the three-month and twelve-month periods ended December 31, 2007 were $315,000 and $710,000 respectively, while in 2006, comparable amounts were $136,000 and $371,000, respectively. These expenses include charges for facilities, communications, investor relations and insurance. Professional fees for the three-month and twelve-month periods ended December 31, 2007 were $156,000 and $586,000 compared to $99,000 and $282,000, respectively, and consisted primarily of legal, accounting and recruiting fees.

The non-cash stock-based compensation charges for the three-month and twelve-month periods ended December 31, 2007 totaled $37,000 and $348,000, respectively, while 2006 charges were $67,000 and $183,000, respectively, as a result of the issuance of options to employees, officers and directors.

Operational expenses were offset in part by interest income of $174,000 and $577,000 during the three-month and twelve-month periods ended December 31, 2007. Interest income in 2006 was $108,000 and $391,000 for the comparable periods. The increase in interest income in 2007 was primarily due to higher interest rates and higher average cash balances after the completion of the June 2007 financing.

As at December 31, 2007, Bradmer had available cash and cash equivalents of $19,469,000 as compared with $8,813,000 as at December 31, 2006. The increase in cash was related to proceeds of the public offering closed on June 22, 2007, which yielded gross proceeds of approximately Cdn$23,100,000. After deducting cash-based share issue costs and converting to US dollars, net proceeds totaled approximately $19,600,000. The Company expects that cash on hand at December 31, 2007 will be sufficient to fund operations at least through 2009, inclusive of clinical trial costs and infrastructure costs during such period.

Operational activities for the year ended December 31, 2007 were financed by cash on hand and the proceeds of the public offering completed in June 2007.

As at December 31, 2007, there were 13,488,215 common shares issued and outstanding.

Outlook

Bradmer's operational objectives are clear: prepare, launch, and execute a multi-center randomized trial evaluating Neuradiab in newly diagnosed GBM patients, which it expects to commence in the spring of 2008. During the time leading up to opening the trial for enrollment, Bradmer intends to execute on the following components of its operational plan:

- Continue the activation and training of glioblastoma multiforme

treatment centers across the U.S.

- Submit final clinical documentation to the FDA, upon completion of

their review of the manufacturing data already submitted.

- Manufacture and ship initial drug quantities to clinical trial sites.

Notice of Conference Call

Bradmer will hold a conference call today, March 12, 2008, at 10:00 a.m. ET hosted by Dr. Alan M. Ezrin, President and Chief Executive Officer and Mr. Paul Van Damme, Chief Financial Officer to discuss the Company's financial results and corporate developments. To access the conference call by telephone, dial 416-644-3420 or 1-800-594-3790. A live audio webcast of the conference call, complete with a slide presentation, will be available by visiting the Company's website at http://www.bradmerpharma.com. Please connect at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be needed to hear the webcast. The webcast will be archived for 90 days.

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

About Bradmer Pharmaceuticals Inc. (http://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 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 $

December 31, December 31,

2007 2006

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

Assets

Current

Cash $ 19,469,337 $ 8,813,427

Amounts receivable 143,722 77,085

Prepaid expenses and other assets 24,029 10,632

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

19,637,088 8,901,144

Patent rights 685,165 469,817

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

$ 20,322,253 $ 9,370,961

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

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

Liabilities

Current

Accounts payable and accrued liabilities $ 1,835,492 $ 1,384,367

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

Shareholders' Equity

Capital stock 31,026,728 12,504,066

Contributed surplus 714,981 183,369

Warrants 881,488 -

Deficit (14,136,436) (4,700,841)

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

18,486,761 7,986,594

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

$ 20,322,253 $ 9,370,961

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

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

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,

2007 2006 2007 2006

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

Expenses

Research &

development $ 2,668,549 $ 2,072,617 $ 6,590,177 $ 2,966,384

Management

salaries 418,569 302,186 1,280,345 745,878

Stock-based

compensation 37,495 66,571 348,412 183,369

Office and

administrative 315,481 136,077 710,122 371,497

Professional fees

and consulting 155,948 98,541 585,690 282,225

Travel 171,051 94,579 536,714 223,015

Amortization and

write-off of

patent rights 14,500 64,797 51,769 92,108

Foreign exchange

gain (90,399) (27,945) (90,399) (27,945)

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

3,691,194 2,807,423 10,012,830 4,836,531

Interest income 174,163 107,895 577,235 390,913

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

Net loss (3,517,031) (2,699,528) (9,435,595) (4,445,618)

Deficit at

beginning

of period (10,619,405) (1,150,032) (4,700,841) (255,223)

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

Deficit at end

of period $(14,136,436) $ (3,849,560) $(14,136,436) $ (4,700,841)

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

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

Basic and diluted

net loss

per share $ (0.26) $ (0.35) $ (0.87) $ (0.57)

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

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

Weighted average

number of shares 13,515,172 7,781,346 10,827,882 7,781,082

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

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

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,

2007 2006 2007 2006

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

Cash flows from

operating

activities

Net loss for

the period $ (3,517,031) $ (2,699,528) $ (9,435,595) $ (4,445,618)

Add item not

affecting cash

Amortization

and write-off

of patents 14,500 64,797 51,769 92,108

Stock-based

compensation 37,495 66,571 348,412 183,369

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

(3,465,036) (2,568,160) (9,035,414) (4,170,141)

Changes in

non-cash

working capital

items

Amounts

receivable 12,692 (167) (66,637) (52,696)

Prepaid

expenses 24,960 19,721 (13,397) (10,632)

Accounts

payable and

accrued

liabilities 1,147,682 1,295,766 451,125 871,628

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

(2,279,702) (1,252,840) (8,664,323) (3,361,841)

Cash flows from

investing

activities

Investment in

patent rights (50,709) (81,217) (267,117) (344,777)

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

Cash flows from

financing

activities

Issuance of

capital stock,

net of share

issue costs - - 19,588,150 12,086,713

Issuance of

capital stock

upon exercise

of stock

options - - - 6,000

Issuance of

capital stock

upon exercise

of warrants - - - 2,414

Cash of former

Bradmer upon

amalgamation - - - 563,405

Promissory note

due to related

party - - - (401,210)

Repurchase of

shares from

employee (800) - (800) -

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

(800) - 19
'/>"/>

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

Related medicine news :

1. Notice of Bradmer Pharmaceuticals Conference Call
2. Bradmer announces Phase II results published in newly diagnosed glioblastoma which demonstrate improved survival and support upcoming Phase III study
3. Bradmer to present at the 10th Annual BIO CEO & Investor Conference
4. Bradmer announces additions to Scientific Advisory Board
5. Bradmer Medical Isotope Supply For Phase III Trial Secure
6. Bradmer to present at Rodman & Renshaw Healthcare Conference
7. Bradmer provides Phase III Neuradiab trial update and guidance
8. Bradmer announces management changes
9. NHP Announces Management Promotions
10. WellPoint Announces Appearances at Upcoming Conferences
11. Mettler-Toledo International Inc. Announces Webcast of Presentation at Lehman Brothers Global Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... ... its strategic partnership with Connance, a healthcare industry leader providing predictive analytics ... proprietary technology combine to provide health systems, hospitals and ambulatory surgical centers ...
(Date:6/26/2016)... , ... June 26, 2016 , ... Pixel Film Studios ... X. , "Film editors can give their videos a whole new perspective by using ... - CEO of Pixel Film Studios. , ProSlice Levels contains over 30 Different ...
(Date:6/25/2016)... , ... June 25, 2016 , ... Austin residents seeking ... American College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical ... effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by ...
(Date:6/25/2016)... ... 25, 2016 , ... Dr. Calvin Johnson has dedicated his ... implemented orthobiologic procedures as a method for treating his patients. The procedure is ... to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use to help ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is World Sickle Cell ... pain and the benefits of holistic treatments, Serenity Recovery Center of Marne, ... Cell Disease. , Sickle Cell Disease (SCD) is a disorder of the red blood ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 24, 2016  Global Blood Therapeutics, Inc. (GBT) (NASDAQ: ... novel therapeutics for the treatment of grievous blood-based ... closing of its previously announced underwritten public offering ... public offering price of $18.75 per share. All ... by GBT. GBT estimates net proceeds from the ...
(Date:6/24/2016)... June 24, 2016 The Academy of Managed ... recommendations that would allow biopharmaceutical companies to more ... that make formulary and coverage decisions, a move that ... new medicines. The recommendations address restrictions in ... on the drug label, a prohibition that hinders decision ...
(Date:6/24/2016)... PUNE, India , June 24, 2016 ... "Pen Needles Market by Type (Standard Pen Needles, Safety ... 12mm), Therapy (Insulin, GLP-1, Growth Hormone), Mode of Purchase ... published by MarketsandMarkets, This report studies the market for ... is expected to reach USD 2.81 Billion by 2021 ...
Breaking Medicine Technology: