EDMONTON, ALBERTA - March 23, 2007 - ViRexx Medical Corp. (TSX:VIR, AMEX:REX), a company focused on the development of immunotherapies for certain cancers, chronic hepatitis B & C and embolotherapy for tumors, announced its financial and operational results for the fiscal year ended December 31, 2006.
“The next twelve months will be a pivotal period for ViRexx as we expect to receive final data analysis from the two identical Phase III trials of OvaRex® MAb and advance our Occlusin™ 500 Device into clinical trials in preparation for a 510(k) submission. With the countdown to the OvaRex® MAb data in its final stages, ViRexx is among a select group of life sciences companies in North America expecting Phase III data within twelve months,” said Dr. Lorne Tyrrell, Chief Executive Officer and Chief Scientific Officer of ViRexx. “During the fourth quarter of 2006, ViRexx completed licensing, supply and manufacturing agreements for OvaRex® MAb in the unlicensed European territories. ViRexx has established partnerships with Sigma-Tau, and its subsidiaries, and Dompé Farmaceutici, both successful marketers of specialty pharmaceutical products in Europe. These agreements represent access to 43% of the currently targeted ovarian cancer markets in North America and the European Union.”
Product Development Highlights
· | Enrollment was completed in the second of two identical OvaRex® MAb Phase III trials for the treatment of late-stage ovarian cancer. The trials are being conducted by ViRexx’s licensee, Unither Pharmaceuticals, Inc. (Unither), a subsidiary of United Therapeutics Corporation. The primary endpoint for each trial is time-to-relapse comparing OvaRex® MAb to placebo. The primary data analysis is scheduled and will occur after each trial has reported at least 118 relapse events. The first trial IMPACT I has achieved the 118th event. It is projected that the second trial, IMPACT II, will reach the 118th event in the second half of 2007. |
· | ViRexx’s licensee, Unither, completed enrollment in a 40 patient OvaRex® MAb Phase II trial, designed to study its use as an adjunct to platinum-based front line chemotherapy in the treatment of advanced ovarian cancer. Unither will present the results at the American Society of Clinical Oncology (ASCO) in June of 2007. |
· | ViRexx International Corp. and Defiante Farmaceutica, Lda. and Tecnogen S.C.p.A., both subsidiaries of Sigma-Tau Pharmaceuticals, Inc. of Rome, Italy, completed manufacturing, licensing and distribution agreements for OvaRex® MAb for the remaining unlicensed European territories which include the UK, Ireland, France, Sweden, Finland and other countries. The agreements provide for ViRexx to receive a net effective royalty of approximately 25% on net sales of OvaRex® MAb in the European and Middle Eastern countries and milestone payments of up to Cdn$6.5 million in equity. The milestone payments included an advanced equity investment of Cdn$2.0 million from Sigma-Tau and its subsidiaries for 1,818,182 units of ViRexx at a price of Cdn$1.10. |
· | A Phase I safety trial of HepaVaxx B Vaccine was completed. The trial enrolled and treated its target of 15 healthy volunteers with a single dose subcutaneous injection of the vaccine; no significant adverse events associated with the treatment have been reported. ViRexx is continuing to monitor the volunteers and expects to complete this safety assessment by the second quarter of 2007. |
· | The Company entered into a research collaboration with Defense Research and Development Canada - Suffield to evaluate the use of the Chimigen™ vaccine platform for biodefense applications. |
· | Enrollment and treatment for the Phase I trial of Occlusin™ 50 Injection in liver cancer patients at the Foothills Hospital in Calgary and the Toronto General Hospital was completed during the year. |
Financial Highlights
(All amounts reported are in Canadian dollars unless otherwise stated)
The Company recorded a net loss for the twelve-month period ended December 31, 2006 of $17,493,375 or $0.25 per share, as compared with a net loss of $7,459,714 or $0.13 per share for the twelve-month period ended December 31, 2005. Approximately 75% of the change in the Company’s net loss for the year ended December 31, 2006 is due to a non-cash change in the net future tax expense associated with the transfer of intellectual property to ViRexx International Corp.
Research and development expenses for the twelve-month period ended December 31, 2006 were $5,937,122, compared with $4,750,190 for the twelve-month period ended December 31, 2005. The difference is primarily due to additional toxicology testing for the HepaVaxx B Vaccine clinical studies and product development and manufacturing costs associated with the Occlusin™ 500 Device.
Corporate Administration expenses for the twelve-month period ended December 31, 2006 were $4,976,837, compared with $3,650,282 for the twelve-month period ended December 31, 2005. The difference is primarily due to expenses related to business development and commercialization activities for OvaRex® MAb in Europe and business development for the T-ACT™ and Chimigen™ technologies. Corporate Administration also includes consulting and other fees associated with the new 52-109 and SOX compliance requirements, as well as restructuring costs relating to ViRexx’s announcement on November 26, 2006 to prioritize its research activities to focus on the completion of its existing pipeline products that provide near-term potential revenue streams.
At December 31, 2006, the Company’s cash and short term investments totalled $10,742,191 as compared to $5,571,850 at December 31, 2005. During the twelve-month period ended December 31, 2006, the Company raised $15,000,000 from the completion of three separate private placements.
At December 31, 2006, the Company had 72,760,717 common shares outstanding. The number of stock options and warrants outstanding at December 31, 2006 is 6,396,241 and 17,077,471, respectively, and could generate proceeds of $29,931,775 if exercised.
About ViRexx Medical Corp.
ViRexx is an Edmonton, Alberta based biotechnology company focused on the development of novel therapeutic products for the treatment of certain cancers and specified chronic viral infections. ViRexx’s most advanced programs include drug candidates for the treatment of ovarian cancer, chronic hepatitis B and C and solid tumors.
ViRexx’s lead product candidate, OvaRex® MAb, a therapy for the treatment of late-stage ovarian cancer, is currently the subject of two Phase III clinical trials being funded by ViRexx’s licensing partner Unither Pharmaceuticals, Inc., a subsidiary of United Therapeutics Corporation. For additional information about ViRexx, please see www.virexx.com.
THE TSX HAS NOT APPROVED OR DISAPPROVED OF THE INFORMATION CONTAINED HEREIN
This news release contains certain forward-looking statements that reflect the current views and/or expectations of the Company with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly.
For more information, please contact:
Lorne Tyrrell Chief Executive Officer ViRexx Medical Corp. Tel: (780) 433-4411 Fax: (780) 436-0068 ltyrrell@virexx.com | Scott Langille Chief Financial Officer ViRexx Medical Corp. Tel: (780) 433-4411 Fax: (780) 436-0068 slangille@virexx.com |
Financial statements attached:
ViRexx Medical Corp.
(a development stage company)
Consolidated Balance Sheets
As at December 31, 2006 and 2005
| | | | | |
(expressed in Canadian dollars) | | | | | |
| | December 31, 2006 $ | | December 31, 2005 $ | |
Assets | | | | | | | |
| | | | | | | |
Current assets | | | | | | | |
Cash | | | 405,354 | | | 237,462 | |
Short-term investments | | | 10,336,837 | | | 5,334,388 | |
Prepaid expenses and deposits | | | 168,502 | | | 166,658 | |
Other current assets | | | 194,476 | | | 39,606 | |
| | | | | | | |
| | | 11,105,169 | | | 5,778,114 | |
Property and equipment | | | 475,079 | | | 518,134 | |
Acquired intellectual property | | | 27,369,445 | | | 29,990,097 | |
| | | | | | | |
| | | 38,949,693 | | | 36,286,345 | |
| | | | | | | |
Liabilities | | | | | | | |
| | | | | | | |
Current liabilities | | | | | | | |
Accounts payable | | | 412,441 | | | 227,625 | |
Accrued liabilities | | | 1,185,762 | | | 442,541 | |
| | | | | | | |
| | | 1,598,203 | | | 670,166 | |
Obligations under capital lease | | | 5,351 | | | - | |
Future income taxes | | | 5,346,990 | | | 1,168,377 | |
| | | | | | | |
| | | 6,950,544 | | | 1,838,543 | |
| | | | | | | |
Commitments and contingencies | | | | | | | |
| | | | | | | |
Shareholders’ Equity | | | | | | | |
| | | | | | | |
Common shares - no par value; unlimited shares authorized; 72,760,717 shares and 58,443,445 shares issued and outstanding, respectively | | | 54,064,680 | | | 45,989,189 | |
Contributed surplus | | | 11,748,640 | | | 4,779,409 | |
Deficit accumulated during development stage | | | (33,814,171 | ) | | (16,320,796 | ) |
| | | | | | | |
| | | 31,999,149 | | | 34,447,802 | |
| | | | | | | |
| | | 38,949,693 | | | 36,286,345 | |
ViRexx Medical Corp.
(a development stage company)
Consolidated Statements of Shareholders’ Equity
| | | | | | | | | | | |
(expressed in Canadian dollars) | | | | | | |
| | Common shares | | | | | | | | | |
| | Number # | | Amount $ | | Equity component of debenture $ | | Contributed surplus $ | | Deficit accumulated during development stage $ | | Total shareholders’ equity $ | |
| | | | | | | | | | | | | | | | | | | |
Balance - October 30, 2000 | | | - | | | - | | | - | | | - | | | - | | | - | |
Shares issued on incorporation | | | 200 | | | 259 | | | - | | | - | | | - | | | 259 | |
Net loss | | | - | | | - | | | - | | | - | | | (177,397 | ) | | (177,397 | ) |
| | | | | | | | | | | | | | | | | | | |
Balance - December 31, 2000 | | | 200 | | | 259 | | | - | | | - | | | (177,397 | ) | | (177,138 | ) |
Issuance of common shares | | | 16,617,283 | | | 1,153,081 | | | - | | | - | | | - | | | 1,153,081 | |
Exercise of warrants | | | 260,039 | | | 207,094 | | | - | | | - | | | - | | | 207,094 | |
Share issue costs | | | - | | | (69,067 | ) | | - | | | - | | | - | | | (69,067 | ) |
Net loss | | | - | | | - | | | - | | | - | | | (1,011,957 | ) | | (1,011,957 | ) |
| | | | | | | | | | | | | | | | | | | |
Balance - December 31, 2001 | | | 16,877,522 | | | 1,291,367 | | | - | | | - | | | (1,189,354 | ) | | 102,013 | |
Shares issued on settlement of debt | | | 682,686 | | | 218,460 | | | - | | | - | | | - | | | 218,460 | |
Issuance of common shares | | | 184,000 | | | 800,024 | | | - | | | - | | | - | | | 800,024 | |
Exercise of warrants | | | 1,869 | | | 1,428 | | | - | | | - | | | - | | | 1,428 | |
Share issue costs | | | - | | | (7,749 | ) | | - | | | - | | | - | | | (7,749 | ) |
Issuance of convertible debenture | | | - | | | - | | | 90,000 | | | - | | | - | | | 90,000 | |
Amalgamation | | | (1,000,000 | ) | | - | | | - | | | - | | | - | | | - | |
Net loss | | | - | | | - | | | - | | | - | | | (1,260,472 | ) | | (1,260,472 | ) |
| | | | | | | | | | | | | | | | | | | |
Balance - December 31, 2002 | | | 16,746,077 | | | 2,303,530 | | | 90,000 | | | - | | | (2,449,826 | ) | | (56,296 | ) |
Issued under private placement | | | 48,000 | | | 31,200 | | | - | | | - | | | - | | | 31,200 | |
Exercise of stock options | | | 300,000 | | | 126,600 | | | - | | | - | | | - | | | 126,600 | |
Conversion of debentures | | | 684,648 | | | 261,277 | | | (30,882 | ) | | - | | | - | | | 230,395 | |
Amalgamation | | | (7,378,725 | ) | | - | | | - | | | - | | | (24,498 | ) | | (24,498 | ) |
Issue of special warrants | | | 5,200,000 | | | 2,881,060 | | | - | | | 205,150 | | | - | | | 3,086,210 | |
Stock options issued to non-employees | | | - | | | - | | | - | | | 85,000 | | | - | | | 85,000 | |
Net loss - restated | | | - | | | - | | | - | | | - | | | (1,383,562 | ) | | (1,383,562 | ) |
| | | | | | | | | | | | | | | | | | | |
Balance - December 31, 2003 | | | 15,600,000 | | | 5,603,667 | | | 59,118 | | | 290,150 | | | (3,857,886 | ) | | 2,095,049 | |
Retroactive adjustment for stock-based compensation | | | - | | | - | | | - | | | 734,773 | | | (734,773 | ) | | - | |
| | | | | | | | | | | | | | | | | | | |
Balance - December 31, 2003 (restated) | | | 15,600,000 | | | 5,603,667 | | | 59,118 | | | 1,024,923 | | | (4,592,659 | ) | | 2,095,049 | |
Issued through public offering | | | 11,000,000 | | | 8,388,820 | | | - | | | 411,180 | | | - | | | 8,800,000 | |
Issued as corporate finance fee | | | 400,000 | | | - | | | - | | | - | | | - | | | - | |
Exercise of warrants | | | 5,500 | | | 5,500 | | | - | | | - | | | - | | | 5,500 | |
Acquisition of AltaRex Medical Corp. | | | 26,257,759 | | | 28,620,957 | | | - | | | - | | | - | | | 28,620,957 | |
Exercise of stock options | | | 13,218 | | | 15,727 | | | - | | | (5,153 | ) | | - | | | 10,574 | |
Share issue costs | | | - | | | (879,688 | ) | | - | | | - | | | - | | | (879,688 | ) |
Fair value of stock options issued on the acquisition of AltaRex | | | - | | | - | | | - | | | 1,815,378 | | | - | | | 1,815,378 | |
Stock-based compensation | | | - | | | - | | | - | | | 380,577 | | | - | | | 380,577 | |
Net loss | | | - | | | - | | | - | | | - | | | (3,657,760 | ) | | (3,657,760 | ) |
| | | | | | | | | | | | | | | | | | | |
Balance - December 31, 2004 | | | 53,276,477 | | | 41,754,983 | | | 59,118 | | | 3,626,905 | | | (8,250,419 | ) | | 37,190,587 | |
| | | | | | | | | | | | | | | | | | | |
Continued on next page |
ViRexx Medical Corp.
(a development stage company)
Consolidated Statements of Shareholders’ Equity …continued
| | | | | | | | | | | |
(expressed in Canadian dollars) | | | | | | | | |
| | Common shares | | | | | | | | | |
| | Number # | | Amount $ | | Equity component of debenture $ | | Contributed surplus $ | | Deficit accumulated during development stage $ | | Total shareholders’ equity $ | |
| | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | |
Balance - December 31, 2004 | | | 53,276,477 | | | 41,754,983 | | | 59,118 | | | 3,626,905 | | | (8,250,419 | ) | | 37,190,587 | |
Repurchase of shares | | | (2,056,900 | ) | | (1,645,113 | ) | | - | | | - | | | (610,663 | ) | | (2,255,776 | ) |
Exercise of stock options | | | 225,218 | | | 267,413 | | | - | | | (75,699 | ) | | - | | | 191,714 | |
Private placement | | | 4,035,665 | | | 2,970,316 | | | - | | | 1,065,349 | | | - | | | 4,035,665 | |
Exercise of warrants | | | 2,302,875 | | | 2,277,370 | | | - | | | (294,495 | ) | | - | | | 1,982,875 | |
Conversion of debentures | | | 561,100 | | | 591,281 | | | - | | | - | | | - | | | 591,281 | |
Conversion and redemption of debentures | - | | | - | | | (59,118 | ) | | - | | | - | | | (59,118 | ) |
Share issue costs | | | 99,010 | | | (227,061 | ) | | - | | | - | | | - | | | (227,061 | ) |
Stock-based compensation | | | - | | | - | | | - | | | 457,349 | | | - | | | 457,349 | |
Net loss | | | - | | | - | | | - | | | - | | | (7,459,714 | ) | | (7,459,714 | ) |
| | | | | | | | | | | | | | | | | | | |
Balance - December 31, 2005 | | | 58,443,445 | | | 45,989,189 | | | - | | | 4,779,409 | | | (16,320,796 | ) | | 34,447,802 | |
Exercise of stock options | | | 590,000 | | | 439,341 | | | - | | | (143,340 | ) | | - | | | 296,001 | |
Private placements | | | 13,527,272 | | | 9,032,430 | | | - | | | 5,967,570 | | | - | | | 15,000,000 | |
Common shares issued | | | 200,000 | | | 148,000 | | | - | | | - | | | - | | | 148,000 | |
Share issue costs | | | - | | | (1,544,280 | ) | | - | | | 539,962 | | | - | | | (1,004,318 | ) |
Stock-based compensation | | | - | | | - | | | - | | | 605,039 | | | - | | | 605,039 | |
Net loss | | | - | | | - | | | - | | | - | | | (17,493,375 | ) | | (17,493,375 | ) |
| | | | | | | | | | | | | | | | | | | |
Balance - December 31, 2006 | | | 72,760,717 | | | 54,064,680 | | | - | | | 11,748,640 | | | (33,814,171 | ) | | 31,999,149 | |
(a development stage company)
Consolidated Statements of Loss
| | | | | | | |
| | | | Years ended December 31, | | Cumulative from October 30, 2000 to | |
| | | | | | | | December 31, | |
| | 2006 $ | | 2005 $ | | 2004 $ (Restated) | | 2006 $ | |
| | | | | | | | | |
Revenue | | - | | - | | - | | - | |
| | | | | | | | | | | | | |
Expenses | | | | | | | | | | | | | |
Research and development | | | 5,937,122 | | | 4,750,190 | | | 1,796,680 | | | 13,892,054 | |
Corporate administration | | | 4,976,837 | | | 3,650,282 | | | 1,887,711 | | | 12,586,301 | |
Amortization | | | 2,771,283 | | | 2,499,174 | | | 71,348 | | | 5,432,626 | |
| | | | | | | | | | | | | |
| | | 13,685,242 | | | 10,899,646 | | | 3,755,739 | | | 31,910,981 | |
| | | | | | | | | | | | | |
Loss from operations | | | (13,685,242 | ) | | (10,899,646 | ) | | (3,755,739 | ) | | (31,910,981 | ) |
| | | | | | | | | | | | | |
Other income (expenses) | | | | | | | | | | | | | |
Interest | | | 400,201 | | | 218,504 | | | 127,728 | | | 753,930 | |
Gain (loss) on disposal of property and equipment | | | 878 | | | - | | | 1,955 | | | (104,842 | ) |
(Loss) gain on foreign exchange | | | (30,599 | ) | | (45,528 | ) | | 14,971 | | | (108,252 | ) |
Debenture interest | | | - | | | (95,201 | ) | | (61,999 | ) | | (272,960 | ) |
Other | | | - | | | 3,731 | | | 15,324 | | | 19,055 | |
| | | | | | | | | | | | | |
| | | 370,480 | | | 81,506 | | | 97,979 | | | 286,931 | |
| | | | | | | | | | | | | |
Loss before income taxes | | | (13,314,762 | ) | | (10,818,140 | ) | | (3,657,760 | ) | | (31,624,050 | ) |
| | | | | | | | | | | | | |
Future income taxes (expense) recovery | | | (4,178,613 | ) | | 3,358,426 | | | - | | | (820,187 | ) |
| | | | | | | | | | | | | |
Net loss | | | (17,493,375 | ) | | (7,459,714 | ) | | (3,657,760 | ) | | (32,444,237 | ) |
| | | | | | | | | | | | | |
| | | | | $ | $ | | | | | $ | | |
| | | | | | | | | | | | | |
Basic and diluted loss per common share | | | (0.25 | ) | | (0.13 | ) | | (0.14 | ) | | | |
| | | | | | | | | | | | | |
| | | # | | | # | | | # | | | | |
| | | | | | | | | | | | | |
Basic and diluted weighted average number of common shares | | | 68,921,409 | | | 55,827,119 | | | 25,268,388 | | | | |
(a development stage company)
Consolidated Statements of Cash Flows
| | | | | | | |
| | | | Years ended December 31, | | Cumulative from October 30, 2000 to | |
| | | | | | | | December 31, | |
| | 2006 $ | | 2005 $ | | 2004 $ (Restated) | | 2006 $ | |
| | | | | | | | | | | | | |
Cash provided by (used in) | | | | | | | | | | | | | |
| | | | | | | | | | | | | |
Operating activities | | | | | | | | | | | | | |
Net loss | | | (17,493,375 | ) | | (7,459,714 | ) | | (3,657,760 | ) | | (32,444,237 | ) |
Items not affecting cash | | | | | | | | | | | | | |
Debenture interest | | | - | | | 95,201 | | | 54,526 | | | 265,487 | |
Amortization | | | 2,771,283 | | | 2,499,174 | | | 71,348 | | | 5,432,626 | |
Stock-based compensation | | | 605,039 | | | 457,349 | | | 380,577 | | | 1,654,265 | |
Investor relations | | | 148,000 | | | - | | | - | | | 148,000 | |
Write off of patent costs | | | - | | | - | | | 242,626 | | | 242,626 | |
(Gain) loss on disposal of property and equipment | | | (878 | ) | | - | | | (1,955 | ) | | 104,842 | |
Unrealized foreign exchange gain | | | - | | | (356 | ) | | (9,471 | ) | | (9,827 | ) |
Future income taxes | | | 4,178,613 | | | (3,358,426 | ) | | - | | | 820,187 | |
Operating assets and liabilities | | | 764,215 | | | 215,670 | | | (346,104 | ) | | 1,155,476 | |
| | | | | | | | | | | | | |
| | | (9,027,103 | ) | | (7,551,102 | ) | | (3,266,213 | ) | | (22,630,555 | ) |
| | | | | | | | | | | | | |
Financing activities | | | | | | | | | | | | | |
Repayment of capital lease | | | (1,755 | ) | | - | | | - | | | (1,755 | ) |
Issuance of share capital - net of share issue costs | | | 14,291,683 | | | 5,983,193 | | | 7,405,027 | | | 33,066,639 | |
Amounts due to related parties | | | - | | | - | | | (35,341 | ) | | - | |
Advances from shareholder | | | - | | | - | | | - | | | 769,900 | |
Repayment of advances from shareholder | | | - | | | - | | | - | | | (769,900 | ) |
Convertible debentures | | | - | | | (600,144 | ) | | - | | | 84,856 | |
Restricted cash | | | | | | 659,000 | | | (659,000 | ) | | - | |
Repurchase of shares | | | - | | | (2,255,776 | ) | | - | | | (2,255,776 | ) |
| | | | | | | | | | | | | |
| | | 14,289,928 | | | 3,786,273 | | | 6,710,686 | | | 30,893,964 | |
| | | | | | | | | | | | | |
Investing activities | | | | | | | | | | | | | |
Acquisition of property and equipment | | | (92,484 | ) | | (131,991 | ) | | (403,364 | ) | | (1,000,906 | ) |
Cash acquired on acquisition | | | - | | | - | | | 3,710,419 | | | 3,729,561 | |
Proceeds on sale of property and equipment | | | - | | | 5,682 | | | 2,861 | | | 17,753 | |
Expenditures on patents and trademarks | | | - | | | - | | | - | | | (267,626 | ) |
(Increase) decrease in short-term investments | | | (5,002,449 | ) | | 3,483,588 | | | (8,817,976 | ) | | (10,336,837 | ) |
| | | | | | | | | | | | | |
| | | (5,094,933 | ) | | 3,357,279 | | | (5,508,060 | ) | | (7,858,055 | ) |
| | | | | | | | | | | | | |
Increase (decrease) in cash | | | 167,892 | | | (407,550 | ) | | (2,063,587 | ) | | 405,354 | |
| | | | | | | | | | | | | |
Cash - Beginning of period | | | 237,462 | | | 645,012 | | | 2,708,599 | | | - | |
| | | | | | | | | | | | | |
Cash - End of period | | | 405,354 | | | 237,462 | | | 645,012 | | | 405,354 | |