Inex releases 2000 operating results & 2001 milestones

Apr 11, 2001, 01:00 ET from Inex Pharmaceuticals Corporation

    VANCOUVER, April 11 /PRNewswire/ - Inex Pharmaceuticals Corporation
 ("INEX"; TSE: IEX) advanced the commercialization of its lead product Onco TCS
 in 2000 by broadening the potential market, recruiting a respected
 biotechnology executive to lead an expanded in-house clinical and regulatory
 team and raising $20 million in equity financing, according to the company's
 2000 audited operating results released today.
     David Main, President and Chief Executive Officer, said the company will
 remain focused in 2001 on executing the company's commercialization plan for
 Onco TCS. The company will also advance products in the pipeline including
 completing the preclinical studies for its new OligoVax therapeutic vaccine
 platform. These initiatives will add considerable value during the year.
     "We believe we have placed the development program for Onco TCS on a
 clear path which will now be augmented by increased efforts on additional
 product candidates," Main said. "We continue to make good progress towards
 completing a partnership for Onco TCS and are pleased with how negotiations
 are proceeding."
     Main said enrolment in the company's pivotal Phase II/III trial has
 reached 22 patients and recent progress continues to support the target of
 full enrolment of 100 patients by the end of 2001. The trial is under way at
 both large urban medical centres in Canada and the United States and at
 community-based physician practices and cancer centres in the United States.
 The community-based hospitals are part of the cancer treatment and research
 network of US Oncology Inc.
     The pivotal Phase II/III clinical trial is evaluating Onco TCS as a
 treatment for relapsed aggressive non-Hodgkin's lymphoma (NHL), one of the
 leading causes of cancer deaths in Canada and the United States. The trial is
 designed to provide sufficient data to apply in late 2002 or early 2003 for
 marketing approval.
 
     Board changes
     -------------
     INEX also announced that its Board of Directors has elected a new
 Chairman and has appointed a new Director.
     Dr. James Miller, a co-founder and former President and CEO of the
 company, has stepped down as Chairman of the Board and will remain a Director.
 The Board has elected Darrell Elliott, who has been a Director since 1995, to
 the position of Chairman. Elliott is Senior Vice President for MDS Capital
 Corp. and President of MDS Ventures Pacific Inc.
     The new Director is Dr. Donald J. McCarren, President and CEO of
 AlphaGene Inc., of Woburn, MA. AlphaGene, Inc. is a privately held gene-
 content functional genomics company. McCarren has an extensive background as
 an executive with several biotechnology and pharmaceutical companies including
 Erbamont NV, Pfizer, Abbott and Merck, with specific expertise in the
 commercialization of new drugs in the oncology and drug delivery fields.
 
     Financial results
     -----------------
     For the fiscal year ended December 31, 2000, the Company reported a net
 loss of $13.8 million ($0.56 per common share). This is consistent with
 management's expectations and compares with a net loss of $11.8 million ($0.84
 per common share) for the fiscal year ended December 31, 1999. The Company
 increased its expenditures to undertake the pivotal Phase II/III clinical
 trial and two Phase II clinical trials for Onco TCS and to carry out the
 regulatory activities associated with the clinical trials.
     Cash and short-term investments at December 31, 2000 were $35.9 million,
 compared with $28.4 million at the end of 1999.
 
     Highlights of 2000
     ------------------
     -  Early in the year, the pivotal Phase II/III clinical trial to
        evaluate Onco TCS as a treatment for relapsed aggressive NHL
        commenced. In August, the United States Food and Drug Administration
        granted Onco TCS "Fast Track" designation. In November, INEX reached
        an agreement with US Oncology Inc. to add community-based physician
        practices and cancer centres to the pivotal Phase II/III trial.
 
     -  Two Phase II clinical trials were launched to evaluate Onco TCS as a
        treatment for small cell lung cancer and as a treatment for relapsed
        solid tumours and leukemia in children and adolescents.
 
     -  Appointment of Alexandra Mancini as Senior Vice President, Clinical
        and Regulatory Affairs, was announced in October. Ms. Mancini is
        expanding the company's in-house clinical development and regulatory
        affairs team to manage the four clinical trials under way in 2000 and
        additional trials launched in 2001.
 
     -  The company raised $20 million in a public equity financing and an
        additional $9.3 million in a government grant to be paid over four
        years.
 
     2001 milestones (achieved during Q1)
     ------------------------------------
     The following milestones for 2001 were achieved during the First Quarter:
 
     -  The spin-off of proprietary gene delivery technology into an
        independently-financed subsidiary Protiva Biotherapeutics Inc. was
        completed
 
     -  A new Phase II clinical trial was launched to evaluate Onco TCS as
        part of a first-line treatment for aggressive non-Hodgkin's lymphoma
        (NHL).
 
     -  The company's initial promising data on a new therapeutic vaccine
        platform called OligoVax to treat cancer and other diseases was
        presented March 27, 2001 at the annual meeting of the American
        Association for Cancer Research (AACR) in New Orleans, Louisiana.
 
     2001 milestones (April through December)
     ----------------------------------------
     The company's key objectives for the final three quarters of 2001 are:
 
     -  Conclude commercial partnership for Onco TCS.
     -  Complete patient enrolment in Onco TCS pivotal Phase II/III trial.
     -  Begin Onco TCS pilot Phase II clinical trial for relapsed aggressive
        NHL in combination with another agent. Complete patient enrolment and
        release data.
     -  Complete patient enrolment in Onco TCS Phase II clinical trial for
        small cell lung cancer.
     -  Complete Phase I clinical trial of INX-3280.
     -  Complete proof-of-principle preclinical studies for OligoVax and begin
        preclinical development studies.
 
     Consolidated Balance Sheets
     (Expressed in Canadian Dollars)
                                              Year ended December 31st
                                                      2000               1999
     ASSETS
     Current
     Cash and cash equivalents                  $3,071,296        $15,797,131
     Short-term investments                     32,877,328         12,611,355
     Accounts receivable                           195,852            270,525
     Inventory                                     312,359                  -
     Government grant receivable                 1,005,335            500,000
     Prepaid expenses and other assets             370,086            103,148
                                              --------------------------------
     Total current assets                       37,832,256         29,282,159
     Long-term investment                          250,000            250,000
     Capital assets                              3,646,992          4,166,374
     Medical Technology                          7,039,943          8,010,970
                                              --------------------------------
                                                48,769,191         41,709,503
                                              --------------------------------
                                              --------------------------------
 
     LIABILITIES AND SHAREHOLDERS' EQUITY
     Current
     Accounts payable and accrued
      liabilities                                2,774,815          1,755,949
     Current portion of deferred lease
      inducements                                   81,863             49,723
                                              --------------------------------
     Total current liabilities                   2,856,678          1,805,672
     Deferred lease inducements                    773,371            884,262
     Obligations under capital leases              110,864             91,875
                                              --------------------------------
     Total liabilities                           3,740,913          2,781,809
                                              --------------------------------
 
     Shareholders' equity
     Common share capital:
     December 31, 2000 -  25,278,730
     December 31, 1999 -  22,361,625           102,281,169         82,380,797
     Deficit                                   (57,252,891)       (43,453,103)
                                              --------------------------------
     Total shareholders' equity                 45,028,278         38,927,694
                                              --------------------------------
                                                48,769,191         41,709,503
                                              --------------------------------
                                              --------------------------------
 
     Consolidated Statements of Loss and Deficit
     (Expressed in
      Canadian       Three Months ended              Twelve Months ended
      Dollars)          December 31                    December 31
                           2000           1999            2000           1999
     Revenue
     Research
      collaborations
      and licensing
      fees            $(300,708)      $618,486         $72,431       $822,466
     Interest and
      other income      678,458        263,601       2,578,536        829,203
                     ---------------------------------------------------------
                        377,750        882,087       2,650,967      1,651,669
                     ---------------------------------------------------------
     Expenses
     Research and
      development     3,381,886      3,432,156      13,069,651     11,219,214
     General and
      adminis-
      trative         1,270,275        710,895       3,381,104      2,269,705
                     ---------------------------------------------------------
                      4,652,161      4,143,051      16,450,755     13,488,919
                     ---------------------------------------------------------
     Net Loss         4,274,411      3,260,964      13,799,788     11,837,250
 
     Deficit,
      Beginning
      of period      52,978,480     40,192,139      43,453,103     31,615,853
                     ---------------------------------------------------------
 
     Deficit, End
      of period      57,252,891     43,453,103      57,252,891     43,453,103
                     ---------------------------------------------------------
     Loss per share       (0.17)         (0.19)          (0.56)         (0.84)
                     ---------------------------------------------------------
 
     Weighted
      average number
      of common
      shares         25,276,579     19,315,964      24,684,713     14,085,756
                     ---------------------------------------------------------
 
     Consolidated Statements of Cash Flow
     (Expressed in Canadian Dollars)           Year ended December 31
                                                       2000              1999
     OPERATING ACTIVITIES
     Loss for the period                       $(13,799,788)     $(11,837,250)
     Amortization of capital assets               1,024,980         1,029,270
     Amortization of medical technology             971,027           971,026
     Amortization of lease inducements             (110,891)         (110,891)
     Accrued interest on short-term
      investments                                  (770,507)         (225,811)
     Loss on sale of capital assets                       -            17,295
     Net change in non-cash working
      capital items related to operations           159,048            29,025
                                               -------------------------------
     Cash used in operating activities          (12,526,131)      (10,127,336)
 
     INVESTING ACTIVITIES
     Acquisition of capital assets                 (305,357)         (435,413)
     Proceeds from sale of capital assets                 -             3,840
     Purchase of short-term investments         (19,495,466)       (3,676,679)
                                               -------------------------------
     Cash used in investing activities          (19,800,823)       (4,108,252)
 
     FINANCING ACTIVITIES
     Issuance of common shares                   19,658,890        28,805,466
     Repayment of obligations under
      capital leases                                (57,771)                -
                                               -------------------------------
     Cash provided by financing activities       19,601,119        28,805,466
                                               -------------------------------
 
     Net increase (decrease) in cash
      for the period                            (12,725,835)       14,569,878
     Cash and cash equivalents, beginning
      of period                                  15,797,131         1,227,253
                                               -------------------------------
     Cash and cash equivalents, end
      of period                                   3,071,296        15,797,131
                                               -------------------------------
 
     INEX is a Canadian biopharmaceutical company that utilizes novel
 therapeutic compounds and proprietary drug delivery systems to commercialize
 improved therapies for the treatment of cancer.
     INEX's common shares are traded on the Toronto Stock Exchange under the
 trading symbol "IEX".
 
 

SOURCE Inex Pharmaceuticals Corporation
    VANCOUVER, April 11 /PRNewswire/ - Inex Pharmaceuticals Corporation
 ("INEX"; TSE: IEX) advanced the commercialization of its lead product Onco TCS
 in 2000 by broadening the potential market, recruiting a respected
 biotechnology executive to lead an expanded in-house clinical and regulatory
 team and raising $20 million in equity financing, according to the company's
 2000 audited operating results released today.
     David Main, President and Chief Executive Officer, said the company will
 remain focused in 2001 on executing the company's commercialization plan for
 Onco TCS. The company will also advance products in the pipeline including
 completing the preclinical studies for its new OligoVax therapeutic vaccine
 platform. These initiatives will add considerable value during the year.
     "We believe we have placed the development program for Onco TCS on a
 clear path which will now be augmented by increased efforts on additional
 product candidates," Main said. "We continue to make good progress towards
 completing a partnership for Onco TCS and are pleased with how negotiations
 are proceeding."
     Main said enrolment in the company's pivotal Phase II/III trial has
 reached 22 patients and recent progress continues to support the target of
 full enrolment of 100 patients by the end of 2001. The trial is under way at
 both large urban medical centres in Canada and the United States and at
 community-based physician practices and cancer centres in the United States.
 The community-based hospitals are part of the cancer treatment and research
 network of US Oncology Inc.
     The pivotal Phase II/III clinical trial is evaluating Onco TCS as a
 treatment for relapsed aggressive non-Hodgkin's lymphoma (NHL), one of the
 leading causes of cancer deaths in Canada and the United States. The trial is
 designed to provide sufficient data to apply in late 2002 or early 2003 for
 marketing approval.
 
     Board changes
     -------------
     INEX also announced that its Board of Directors has elected a new
 Chairman and has appointed a new Director.
     Dr. James Miller, a co-founder and former President and CEO of the
 company, has stepped down as Chairman of the Board and will remain a Director.
 The Board has elected Darrell Elliott, who has been a Director since 1995, to
 the position of Chairman. Elliott is Senior Vice President for MDS Capital
 Corp. and President of MDS Ventures Pacific Inc.
     The new Director is Dr. Donald J. McCarren, President and CEO of
 AlphaGene Inc., of Woburn, MA. AlphaGene, Inc. is a privately held gene-
 content functional genomics company. McCarren has an extensive background as
 an executive with several biotechnology and pharmaceutical companies including
 Erbamont NV, Pfizer, Abbott and Merck, with specific expertise in the
 commercialization of new drugs in the oncology and drug delivery fields.
 
     Financial results
     -----------------
     For the fiscal year ended December 31, 2000, the Company reported a net
 loss of $13.8 million ($0.56 per common share). This is consistent with
 management's expectations and compares with a net loss of $11.8 million ($0.84
 per common share) for the fiscal year ended December 31, 1999. The Company
 increased its expenditures to undertake the pivotal Phase II/III clinical
 trial and two Phase II clinical trials for Onco TCS and to carry out the
 regulatory activities associated with the clinical trials.
     Cash and short-term investments at December 31, 2000 were $35.9 million,
 compared with $28.4 million at the end of 1999.
 
     Highlights of 2000
     ------------------
     -  Early in the year, the pivotal Phase II/III clinical trial to
        evaluate Onco TCS as a treatment for relapsed aggressive NHL
        commenced. In August, the United States Food and Drug Administration
        granted Onco TCS "Fast Track" designation. In November, INEX reached
        an agreement with US Oncology Inc. to add community-based physician
        practices and cancer centres to the pivotal Phase II/III trial.
 
     -  Two Phase II clinical trials were launched to evaluate Onco TCS as a
        treatment for small cell lung cancer and as a treatment for relapsed
        solid tumours and leukemia in children and adolescents.
 
     -  Appointment of Alexandra Mancini as Senior Vice President, Clinical
        and Regulatory Affairs, was announced in October. Ms. Mancini is
        expanding the company's in-house clinical development and regulatory
        affairs team to manage the four clinical trials under way in 2000 and
        additional trials launched in 2001.
 
     -  The company raised $20 million in a public equity financing and an
        additional $9.3 million in a government grant to be paid over four
        years.
 
     2001 milestones (achieved during Q1)
     ------------------------------------
     The following milestones for 2001 were achieved during the First Quarter:
 
     -  The spin-off of proprietary gene delivery technology into an
        independently-financed subsidiary Protiva Biotherapeutics Inc. was
        completed
 
     -  A new Phase II clinical trial was launched to evaluate Onco TCS as
        part of a first-line treatment for aggressive non-Hodgkin's lymphoma
        (NHL).
 
     -  The company's initial promising data on a new therapeutic vaccine
        platform called OligoVax to treat cancer and other diseases was
        presented March 27, 2001 at the annual meeting of the American
        Association for Cancer Research (AACR) in New Orleans, Louisiana.
 
     2001 milestones (April through December)
     ----------------------------------------
     The company's key objectives for the final three quarters of 2001 are:
 
     -  Conclude commercial partnership for Onco TCS.
     -  Complete patient enrolment in Onco TCS pivotal Phase II/III trial.
     -  Begin Onco TCS pilot Phase II clinical trial for relapsed aggressive
        NHL in combination with another agent. Complete patient enrolment and
        release data.
     -  Complete patient enrolment in Onco TCS Phase II clinical trial for
        small cell lung cancer.
     -  Complete Phase I clinical trial of INX-3280.
     -  Complete proof-of-principle preclinical studies for OligoVax and begin
        preclinical development studies.
 
     Consolidated Balance Sheets
     (Expressed in Canadian Dollars)
                                              Year ended December 31st
                                                      2000               1999
     ASSETS
     Current
     Cash and cash equivalents                  $3,071,296        $15,797,131
     Short-term investments                     32,877,328         12,611,355
     Accounts receivable                           195,852            270,525
     Inventory                                     312,359                  -
     Government grant receivable                 1,005,335            500,000
     Prepaid expenses and other assets             370,086            103,148
                                              --------------------------------
     Total current assets                       37,832,256         29,282,159
     Long-term investment                          250,000            250,000
     Capital assets                              3,646,992          4,166,374
     Medical Technology                          7,039,943          8,010,970
                                              --------------------------------
                                                48,769,191         41,709,503
                                              --------------------------------
                                              --------------------------------
 
     LIABILITIES AND SHAREHOLDERS' EQUITY
     Current
     Accounts payable and accrued
      liabilities                                2,774,815          1,755,949
     Current portion of deferred lease
      inducements                                   81,863             49,723
                                              --------------------------------
     Total current liabilities                   2,856,678          1,805,672
     Deferred lease inducements                    773,371            884,262
     Obligations under capital leases              110,864             91,875
                                              --------------------------------
     Total liabilities                           3,740,913          2,781,809
                                              --------------------------------
 
     Shareholders' equity
     Common share capital:
     December 31, 2000 -  25,278,730
     December 31, 1999 -  22,361,625           102,281,169         82,380,797
     Deficit                                   (57,252,891)       (43,453,103)
                                              --------------------------------
     Total shareholders' equity                 45,028,278         38,927,694
                                              --------------------------------
                                                48,769,191         41,709,503
                                              --------------------------------
                                              --------------------------------
 
     Consolidated Statements of Loss and Deficit
     (Expressed in
      Canadian       Three Months ended              Twelve Months ended
      Dollars)          December 31                    December 31
                           2000           1999            2000           1999
     Revenue
     Research
      collaborations
      and licensing
      fees            $(300,708)      $618,486         $72,431       $822,466
     Interest and
      other income      678,458        263,601       2,578,536        829,203
                     ---------------------------------------------------------
                        377,750        882,087       2,650,967      1,651,669
                     ---------------------------------------------------------
     Expenses
     Research and
      development     3,381,886      3,432,156      13,069,651     11,219,214
     General and
      adminis-
      trative         1,270,275        710,895       3,381,104      2,269,705
                     ---------------------------------------------------------
                      4,652,161      4,143,051      16,450,755     13,488,919
                     ---------------------------------------------------------
     Net Loss         4,274,411      3,260,964      13,799,788     11,837,250
 
     Deficit,
      Beginning
      of period      52,978,480     40,192,139      43,453,103     31,615,853
                     ---------------------------------------------------------
 
     Deficit, End
      of period      57,252,891     43,453,103      57,252,891     43,453,103
                     ---------------------------------------------------------
     Loss per share       (0.17)         (0.19)          (0.56)         (0.84)
                     ---------------------------------------------------------
 
     Weighted
      average number
      of common
      shares         25,276,579     19,315,964      24,684,713     14,085,756
                     ---------------------------------------------------------
 
     Consolidated Statements of Cash Flow
     (Expressed in Canadian Dollars)           Year ended December 31
                                                       2000              1999
     OPERATING ACTIVITIES
     Loss for the period                       $(13,799,788)     $(11,837,250)
     Amortization of capital assets               1,024,980         1,029,270
     Amortization of medical technology             971,027           971,026
     Amortization of lease inducements             (110,891)         (110,891)
     Accrued interest on short-term
      investments                                  (770,507)         (225,811)
     Loss on sale of capital assets                       -            17,295
     Net change in non-cash working
      capital items related to operations           159,048            29,025
                                               -------------------------------
     Cash used in operating activities          (12,526,131)      (10,127,336)
 
     INVESTING ACTIVITIES
     Acquisition of capital assets                 (305,357)         (435,413)
     Proceeds from sale of capital assets                 -             3,840
     Purchase of short-term investments         (19,495,466)       (3,676,679)
                                               -------------------------------
     Cash used in investing activities          (19,800,823)       (4,108,252)
 
     FINANCING ACTIVITIES
     Issuance of common shares                   19,658,890        28,805,466
     Repayment of obligations under
      capital leases                                (57,771)                -
                                               -------------------------------
     Cash provided by financing activities       19,601,119        28,805,466
                                               -------------------------------
 
     Net increase (decrease) in cash
      for the period                            (12,725,835)       14,569,878
     Cash and cash equivalents, beginning
      of period                                  15,797,131         1,227,253
                                               -------------------------------
     Cash and cash equivalents, end
      of period                                   3,071,296        15,797,131
                                               -------------------------------
 
     INEX is a Canadian biopharmaceutical company that utilizes novel
 therapeutic compounds and proprietary drug delivery systems to commercialize
 improved therapies for the treatment of cancer.
     INEX's common shares are traded on the Toronto Stock Exchange under the
 trading symbol "IEX".
 
 SOURCE Inex Pharmaceuticals Corporation