For immediate release: October 28, 2004
VANCOUVER - Inex Pharmaceuticals Corporation (INEX; TSX: IEX) reported today in its third quarter 2004 operating results that it remains focused on working towards United States Food and Drug Administration (FDA) approval of its lead product Marqibo™ (formerly referred to as Onco TCS) and on advancing its second product INX-0125 into clinical trials.
David Main, INEX’s President and CEO, said that the Company’s top priority remains the FDA review of Marqibo™ as a treatment for patients with relapsed aggressive non-Hodgkin’s lymphoma (NHL). INEX is working with Enzon Pharmaceuticals Inc (Enzon; NASDAQ: ENZN), its North American partner for Marqibo™, to prepare for a presentation to the FDA’s Oncologic Drugs Advisory Committee (ODAC) on December 1, 2004 and for commercialization and product launch.
Main said other progress in the third quarter included preparation for filing of an Investigational New Drug (IND) application before the end of 2004 to begin clinical trials for INX-0125, the Company’s second product. Clinical development of INX-0125 is anticipated to begin in the first half of 2005.
“Our progress in the third quarter moves us closer to our objectives of commercializing Marqibo™ as a treatment for patients with relapsed NHL and becoming a fully integrated biopharmaceutical company,” Main said.
Marqibo™
Marqibo™ (vincristine sulfate liposomes injection) is a proprietary drug comprised of the widely used off-patent anticancer drug vincristine encapsulated in INEX’s liposomal drug delivery technology. This technology is designed to provide prolonged blood circulation, tumor accumulation and extended drug release at the cancer site. These characteristics are intended to increase the effectiveness and reduce the side effects of the encapsulated drug.
INEX and Enzon are expecting a response from the FDA by January 15, 2005 on the approvability of a New Drug Application (NDA) seeking marketing approval for Marqibo™ as a single-agent treatment for patients with relapsed aggressive non-Hodgkin’s lymphoma (NHL) previously treated with at least two combination chemotherapy regimens.
The two companies are progressing with the necessary preparations for the commercial launch and further development of Marqibo™. These preparations include expanded clinical development, key opinion leader development and the completion of marketing and launch plans.
ODAC Presentation
INEX and Enzon announced on September 27, 2004 that the FDA will include in its review of Marqibo™ an evaluation by ODAC on December 1, 2004. ODAC is a committee of external experts that advises the FDA in the evaluation of marketed and investigational drugs for use in the treatment of cancer.
Marqibo™ clinical development
Marqibo™ is currently being evaluated in several phase II clinical trials as a treatment for first-line NHL (combination therapy), relapsed Hodgkin’s disease, relapsed acute lymphoblastic leukemia (ALL) in combination with the approved cancer drug dexamethasone, relapsed NHL in combination with the approved cancer drug Rituxan® (rituximab), and relapsed NHL in combination with the approved cancer drug etoposide.
INEX and Enzon will release data from three trials at the upcoming American Society of Hematology meeting to be held in San Diego December 4-7, 2004. Data to be released includes additional analysis on the pivotal phase II/III trial evaluating Marqibo™ as a single agent treatment for relapsed aggressive NHL; additional follow up data from the first-line NHL phase II trial (combination therapy) and initial data from a phase I/II dose escalation trial evaluating Marqibo™ in combination with the anticancer drug dexamethasone for the treatment of patients with relapsed ALL.
INX-0125 (liposomal vinorelbine)
INX-0125 is the second anticancer drug under development in INEX’s Targeted Chemotherapy platform. It comprises the off-patent anticancer drug vinorelbine encapsulated in the Company’s liposomal drug delivery technology. Vinorelbine is similar in chemical structure to vincristine, the active component of Marqibo™, but is used to treat different cancers, including breast and lung cancer. Preclinical data demonstrates that INX-0125 is more active against breast, colon and lung cancers than free vinorelbine.
The Company recently completed the manufacturing of its first clinical scale batch of INX-0125 and remains on track to file an IND by the end of the year seeking approval to commence human clinical trials. A phase I clinical trial would start in the first half of 2005.
If INX-0125 is successful in clinical trials, and if resources permit, INEX will take this product through to commercialization in North America without a partner, allowing the Company to retain all sales revenues.
INX-0076 (liposomal topotecan)
INEX’s third anticancer drug, INX-0076, was being developed under a partnership agreement with international pharmaceutical company GlaxoSmithKline (GSK; LSE and NYSE:GSK). INEX announced on August 4, 2004 that GSK had decided to terminate the agreement to develop INX-0076. The termination took effect on September 1, 2004.
INEX and GSK entered into an agreement in November 2001 to develop GSK’s anticancer drug, topotecan hydrochloride, encapsulated within INEX’s proprietary liposomal drug delivery technology. All of the preclinical studies including toxicology had been completed in anticipation of clinical development. However, the program was delayed after GSK experienced a number of technical problems in manufacturing the necessary supply of materials needed for clinical trials. During the quarter, GSK paid INEX US$0.75 million for milestones completed before termination. To date, GSK has paid INEX US$6.0 million in upfront and milestone payments.
INEX is currently evaluating its options regarding INX-0076, including whether to continue to develop INX-0076 or modify the product by encapsulating a different anticancer agent from the camptothecin class.
Targeted Immunotherapy
INEX's second platform technology, Targeted Immunotherapy, induces the body's immune system to fight cancer and infectious diseases by delivering drugs that stimulate an immune response directly to the appropriate target cells.
INX-0204
INX-0204 is the Company’s early-stage vaccine product candidate. INX-0204 is encapsulated oligonucleotides (short sequences of DNA) in combination with specific disease markers, called antigens. The addition of an antigen results in a specific response throughout the body by the immune system that is directed toward disease cells that are associated with the antigen.
In preclinical studies, INX-0204 achieved proof-of-principle by demonstrating that it can stimulate the immune system to inhibit the growth of tumors. The Company has ongoing research collaborations with organizations whose antigens can be combined with INX-0204 to form therapeutic products to treat specific conditions, including cancer and infectious diseases.
INX-0167
INX-0167 is the encapsulation of oligonucleotides in INEX’s liposomal technology. INX-0167 has demonstrated in preclinical studies the capacity to enhance the immunostimulatory response of monoclonal antibodies.
INEX presented data on INX-0167 on July 18, 2004 at the 12th International Congress of Immunology and the 4th Annual Conference of the Federation of Clinical Immunological Societies in Montreal. This data showed INX-0167 enhances the number and potency of certain immune cells, including natural killer (NK) cells. The resultant increase in NK cell activity is important for the enhancement of the potency of monoclonal antibodies through a mechanism known as antibody-dependent cell mediated cytotoxicity (ADCC).
Data presented in a preclinical model of lymphoma demonstrated that treatment with the monoclonal antibody rituximab (Rituxan®) prolonged median survival by 25% longer than control and that treatment with INX-0167 prolonged survival by 110% longer than control. However, combining INX-0167 and rituximab produced a synergistic response prolonging median survival by more than 500% longer than control.
Monoclonal antibodies currently comprise a multi-billion dollar segment of the cancer treatment market – and therefore INX-0167 presents a significant opportunity for INEX. The Company is now deciding the most appropriate development strategy for INX-0167.
Internally at INEX, the focus within the Targeted Immunotherapy platform is on advancing INX-0167.
Financials
The net loss for the nine months ended September 30, 2004 was $17.2 million ($0.50 per common share) as compared to $31.8 million ($0.98 per common share) in the first nine months of 2003. For the third quarter of 2004, the net loss was $6.6 million ($0.19 per common share) and compares with a net loss of $10.4 million ($0.30 per common share) for the same period in 2003 and $5.6 million ($0.16 per common share) for the second quarter of 2004. These net losses were in line with expectations. The decrease in the current periods’ losses as compared to the losses in 2003 is largely due to an increase in revenue, primarily arising from the Company’s partnership agreement with Enzon entered into in January 2004 and a significant decline in research and development spending on pre-commercial manufacturing activities related to Marqibo™ because most of this work was completed in 2003. The increase in loss in the third quarter over the second quarter of 2004 is largely due to foreign exchange losses on US dollar denominated holdings of cash and short-term investments.
INEX commenced the filing of a NDA in the US seeking marketing approval for Marqibo™ in the third quarter of 2003 and completed the filing in March 2004. The NDA was accepted in May 2004 and has been granted a Standard Review designation. The US Food and Drug Administration (FDA) is continuing its review of INEX’s NDA which includes audits of manufacturing and clinical trial sites included in the NDA submission. On September 27, 2004, the Company announced that the FDA will review Marqibo™ at its upcoming ODAC session scheduled for December 1, 2004. The FDA has established a target date of January 15, 2005 for the completion of its review of the Marqibo™ NDA.
In November 2001, INEX entered into an agreement with GlaxoSmithKline (GSK) to develop their anticancer drug, topotecan hydrochloride, with INEX’s proprietary liposomal drug delivery technology (INX-0076). However, GSK had experienced a number of technical problems in manufacturing the necessary supply of materials needed for clinical trials, and these problems delayed the program. On August 4, 2004, INEX announced that GSK had decided to terminate the agreement to develop INX-0076 effective September 1, 2004. The Company is currently evaluating options for INX-0076, including whether to continue to develop INX-0076 or to modify the drug using a different anticancer agent similar in chemical structure.
At September 30, 2004, INEX had cash, cash equivalents and short-term investments of approximately $36.8 million as compared to $50.8 million at December 31, 2003. INEX believes that current funds on hand, anticipated funding from corporate partners and government grants, and expected interest income, will be sufficient to finance currently planned operations and capital needs for approximately two years. Funding needs may vary, however, depending upon a number of factors as more fully outlined in the Company’s 2003 Annual Report.
Revenues from research and development collaborations, licensing fees and milestone payments were $10.3 million for the first nine months of 2004 and $3.3 million for the comparable period in 2003. Revenues were $3.3 million for the third quarter of 2004 and $0.8 million for the third quarter of 2003. The overall increase in revenue from 2003 is largely attributable to revenue recorded from Enzon in conjunction with a strategic partnership agreement, entered into in January 2004, to jointly develop and commercialize Marqibo™ in North America.
Revenue from research and development collaborations in 2004 was $4.2 million in the first nine months and $1.6 million in the third quarter of 2004 as compared to nil in the same periods in 2003. This was a result of revenue recorded from Enzon in relation to Enzon’s share of ongoing development expenses for Marqibo™.
The following table shows a break-down of licensing fees and milestone revenue.
Licensing fees and milestone revenue
(in millions CDN$)
Three Months Ended Nine Months Ended
Sept 30, Sept 30, Sept 30, Sept 30,
2004 2003 2004 2003
Amortization of
Enzon up-front payment(1) $ 0.6 $ - $ 4.3 $ -
GSK revenue(2)
Amortization of initial license fee 0.2 0.1 0.5 0.4
Milestone payments 1.0 0.7 1.3 2.9
Total $ 1.9 $ 0.8 $ 6.1 $ 3.3
(1) Amortization of the up-front US$2.0 million and US$10.0 million payment received from Enzon at the start of the strategic partnership in January 2004.
(2) The GSK revenue was earned pursuant to an agreement to develop GSK’s anticancer drug, topotecan hydrochloride, with INEX’s proprietary liposomal drug delivery technology (INX-0076). However, GSK had experienced a number of technical problems in manufacturing the necessary supply of materials needed for clinical trials, and these problems delayed the program. INEX announced on August 4, 2004 that GSK had decided to terminate the agreement to develop INX-0076. The termination took effect on September 1, 2004. INEX will not be receiving any further payments under this agreement and all revenue received and deferred under the agreement has now been amortized into income.
Research and development expenses decreased to $18.3 million in the first nine months of 2004 as compared to $22.4 million in the comparable period in 2003. Research and development expenses were $6.3 million for the third quarter of 2004 and $7.5 million for the third quarter in 2003.The decline is mainly the result of a significant decline in spending on pre-commercial manufacturing, clinical trials and other activities related to the NDA for Marqibo™ since most of this work was completed in 2003. Partially offsetting the overall decrease in research and development expenses was an increase in spending on the development of INX-0125 (liposomal vinorelbine) including preclinical studies and the manufacture of the first clinical scale batch for INX-0125.
General and administrative expenses increased $0.7 million to $7.1 million for the first nine months of 2004 as compared to the same period in 2003. General and administrative expenses were $2.4 million for the third quarter of 2004, $2.4 million for the second quarter of 2004 and $2.0 million for the third quarter of 2003. In preparation for the commercialization of Marqibo™ and pursuant to the Company’s right to co-promote the product with Enzon, the Company incurred increased recruiting costs this year in initiating the hiring of commercial personnel.
Amortization expense is $2.5 million year-to-date as compared to $6.7 million for the comparable period in 2003. Amortization expense was approximately $0.9 million for the third quarter of 2004 and $2.2 million for the third quarter of 2003. The primary source of the decreases from 2003 was a change in the estimated useful life of the Marqibo™ medical technology that was licensed from Elan Corporation, plc (Elan) in April 2001. At the time the medical technology was licensed, the useful life was estimated as three years. Based on more recent developments and the Company’s expectations of reaching product commercialization, commencing in the first quarter of 2004 the estimated useful life of this medical technology has been extended for an additional 10 years. As a result, the amortization expense of the Marqibo™ medical technology in the first nine months of 2004 was $0.5 million as compared to $4.6 million in the first nine months of 2003.
Interest income is $0.7 million year-to-date as compared to $1.1 for the comparable period in 2003. Interest income was $0.2 million for the third quarter of 2004 and $0.4 million for the third quarter of 2003. The other losses in the third quarter and first nine months of 2004 are mainly the result of foreign exchange losses on US dollar denominated holdings of cash and short-term investments.
Capital expenditures were $1.2 million, none of which were funded by capital leases, during the nine month period ended September 30, 2004 as compared to $0.6 million, including $0.2 million funded by capital leases, during the same period in 2003. Capital expenditures in the current period largely relate to equipment purchased in preparation for the commercial production of Marqibo.
Risks and Uncertainties
To the extent possible, management implements strategies to reduce or mitigate the risks and uncertainties associated with INEX’s business. Operating risks include:
· INEX’s ability to successfully complete preclinical and clinical development of its products;
· Decisions, and the timing of decisions, made by health regulatory agencies regarding approval of INEX’s technology and products including the approvability of Marqibo™ by the FDA under its Accelerated Approval legislation;
· The effectiveness of INEX’s contract manufacturers in obtaining regulatory approval to manufacture Marqibo™;
· The effectiveness of INEX’s partners in carrying out the development and commercialization of its product candidates including, subject to regulatory approval in the US, Enzon’s ability to successfully launch Marqibo™;
· If approved, the degree and rate of market acceptance for Marqibo™;
· The continued availability of capital to finance INEX’s activities; and
· The ability to attract and retain qualified personnel.
INEX’s risks and uncertainties are discussed in further detail in the “Management’s Discussion and Analysis of Financial Condition and Operations” portion of its 2003 Annual Report and in its Annual Information Form dated May 13, 2004 and remain substantially unchanged. Both the 2003 Annual Report and Annual Information Form are available on www.sedar.com
The unaudited interim consolidated financial statements presented here have been prepared in accordance with Canadian generally accepted accounting principles for interim financial information.
| Consolidated Balance Sheets (Expressed in Canadian Dollars) | ||||
| September 30, 2004 (unaudited) |
December 31, 2003 | |||
|
| ||||
| ASSETS | ||||
| Current assets | ||||
| Cash and cash equivalents | $30,096,300 | $46,107,754 | ||
| Short-term investments | 6,685,469 |
4,732,287 | ||
| Accounts receivable | 1,942,831 |
436,062 | ||
| Government grant receivable | 25,804 | 70,000 | ||
| Inventories | 302,100 | - | ||
| Prepaid expenses and other assets | 374,876 |
649,511 | ||
|
| ||||
| Total current assets | 39,427,380 |
51,995,614 | ||
| Long-term investment | 908,643 | 2,001,166 | ||
| Property and equipment | 5,193,511 | 5,313,178 | ||
| Medical technology | 12,286,570 | 6,178,225 | ||
| Other long-term assets | 1,464,049 | 296,328 | ||
|
| ||||
| $59,280,153 | $65,784,511 | |||
|
| ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | |||
| Current liabilities | |||
| Accounts payable and accrued liabilities | $2,525,797 | $4,835,501 | |
| Current portion of obligations under capital leases |
136,027 | 174,131 | |
| Current portion of long-term debt | 815,171 | 365,906 | |
| Current portion of deferred revenue | 2,208,000 | 503,310 | |
|
| |||
| Total current liabilities | 5,684,995 | 5,878,848 | |
| Obligations under capital leases | 171,359 | 264,911 | |
| Long-term debt | 1,255,446 | 781,096 | |
| Deferred lease inducements | 449,496 | 440,699 | |
| Deferred revenue | 9,384,000 | - | |
| Deferred dilution gain | 1,069,905 | 2,162,428 | |
|
| |||
| Total liabilities | 18,015,201 | 9,527,982 | |
|
| |||
| Shareholders' equity | |||
| Common share capital: | |||
| September 30, 2004 - 38,556,788 | 180,237,917 | 179,097,330 | |
| December 31, 2003 - 38,409,633 | |||
| Additional paid-in capital | 14,766,610 | 13,684,109 | |
| Exchangeable and Development Notes | 50,354,313 | 48,243,515 | |
| Deficit | (204,093,888) |
(184,768,425) | |
|
| |||
| Total shareholders' equity |
41,264,952 | 56,256,529 | |
|
| |||
| $59,280,153 | $65,784,511 | ||
|
| |||
| Consolidated Statements of Loss and Deficit (Expressed in Canadian Dollars) | ||||
|
Three Months Ended |
Nine Months Ended | |||
|
September 30, 2004 |
September 30, 2003 |
September 30, 2004 |
September 30, 2003 | |
|
unaudited |
unaudited restated |
unaudited |
unaudited restated | |
|
| ||||
| Revenue | ||||
| Research and development collaborations |
$1,567,313 | $ - | $4,199,587 | $ - |
| Licensing fees and milestone payments |
1,755,195 | 823,917 | 6,102,128 | 3,302,622 |
|
| ||||
| 3,322,508 | 823,917 | 10,301,715 | 3,302,622 | |
|
| ||||
| Expenses | ||||
| Research and development |
6,329,484 | 7,534,977 | 18,255,377 | 22,433,608 |
| General and administrative |
2,414,683 | 1,980,218 | 7,102,446 | 6,378,732 |
| Amortization | 897,856 | 2,213,080 | 2,547,007 | 6,725,688 |
|
| ||||
| 9,642,023 | 11,728,275 | 27,904,830 | 35,538,028 | |
|
| ||||
| Loss before other income (losses) |
(6,319,515) | (10,904,358) | (17,603,115) | (32,235,406) |
| Interest income | 185,886 |
414,362 | 726,536 | 1,110,153 |
| Other income (losses) | (427,910) |
117,912 | (338,086) | (708,984) |
| Dilution gain from Protiva Biotherapeutics Inc. |
386,231 | 421,501 | 1,092,523 | 1,238,115 |
| Equity in loss of Protiva Biotherapeutics Inc. |
(386,231) | (421,501) | (1,092,523) | (1,238,115) |
|
| ||||
| Net Loss | $(6,561,539) | ($10,372,084) | $(17,214,665) | $(31,834,237) |
| Deficit, Beginning of period | (196,823,753) | (160,645,930) | (184,768,425) | (137,782,023) |
| Interest on Exchangeable and Development Notes |
(708,596) | (708,652) | (2,110,798) | (2,110,407) |
|
| ||||
| Deficit, End of period | $(204,093,888) | $(171,726,666) | $(204,093,888) | $(171,726,667) |
|
| ||||
|
| ||||
| Loss per common share | $(0.19) | $(0.30) | $(0.50) | $(0.98) |
| Weighted average number of common shares |
38,559,320 | 37,389,440 | 38,506,976 | 34,689,708 |
|
| ||||
| Consolidated Statements of Shareholders' Equity | ||||
| (Expressed in Canadian Dollars) | ||||
| Nine months ended September 30, 2004 (Unaudited) | ||||
|
Number of shares |
Share capital |
Additional paid-in capital | ||
|
| ||||
| Balance, December 31, 2003 | 38,409,633 | $179,097,330 | $13,684,109 | |
| Net loss | - | - | - | |
| Stock-based compensation | - | - | 1,464,345 | |
| Issuance of common shares pursuant to exercise of options | 157,155 | 1,140,587 | (381,844) | |
| Accrued interest on exchangeable and development notes | - | - | - | |
|
| ||||
| Balance, September 30, 2004 | 38,566,788 | $180,237,917 | $14,766,610 | |
|
| ||||
| Nine months ended September 30, 2004 (Unaudited) (continued) | ||||
|
Exchangeable and development notes |
Deficit |
Total shareholders' equity | ||
|
| ||||
| Balance, December 31, 2003 | $48,243,515 | $(184,768,425) | $56,256,529 | |
| Net loss | - | (17,214,665) | (17,214,665) | |
| Stock-based compensation | - | - | 1,464,345 | |
| Issuance of common shares pursuant to exercise of options | - | - | 758,743 | |
| Accrued interest on exchangeable and development notes | 2,110,798 | (2,110,798) | - | |
|
| ||||
| Balance, September 30, 2004 | $50,354,313 | $(204,093,888) | $41,264,952 | |
|
| ||||
| Nine months ended September 30, 2003 (Unaudited) | ||||
|
Number of shares |
Share capital |
Additional paid-in capital | ||
|
| ||||
| Balance, December 31, 2002 | 32,974,762 | $152,617,301 | $11,110,970 | |
| Net loss | ||||
| Stock-based compensation | ||||
| Issuance of common shares pursuant to: | ||||
| Public offering, net of issue costs of $1,757,845 | 5,012,200 | 25,558,645 | 1,725,497 | |
| Exercise of options | 402,411 | 766,305 | (310,330) | |
| Accrued interest on exchangeable and development notes | ||||
|
| ||||
| Balance, September 30, 2003 | 38,389,373 | $178,942,251 | $12,526,137 | |
|
| ||||
| Nine months ended September 30, 2003 (Unaudited) (continued) | ||||
|
Exchangeable and development notes |
Deficit |
Total shareholders' equity | ||
|
| ||||
| Balance, December 31, 2002 | $45,446,478 | $(137,782,022) | $71,392,727 | |
| Net loss | (31,834,237) | (31,834,237) | ||
| Stock-based compensation | 1,725,497 | |||
| Issuance of common shares pursuant to: | ||||
| Public offering, net of issue costs of $1,757,845 |
25,558,645 | |||
| Exercise of options | 455,975 | |||
| Accrued interest on exchangeable and development notes | 2,110,407 | (2,110,407) | - | |
|
| ||||
| Balance, September 30, 2003 | $47,556,885 | $(171,726,666) | $67,298,607 | |
|
| ||||
| Consolidated Statements of Cash Flows (Expressed in Canadian Dollars) | |||||
|
Three Months Ended |
Nine Months Ended | ||||
|
September 30, 2004 |
September 30, 2003 |
September 30, 2004 |
September 30, 2003 | ||
|
| |||||
|
unaudited |
unaudited restated |
unaudited |
unaudited restated | ||
| OPERATIONS | |||||
| Loss for the period | $(6,561,539) |
$(10,372,084) |
$(17,214,665) | $(31,834,237) | |
| Items not involving cash: | |||||
| Amortization of property and equipment |
415,721 | 431,802 | 1,280,804 |
1,381,855 | |
| Amortization of medical technology |
482,135 | 1,781,278 | 1,266,203 | 5,343,833 | |
| Amortization of deferred revenue |
(770,444) | (131,067) | (4,786,175) |
(393,200) | |
| Amortization of deferred lease inducements |
(34,796) |
(27,724) | (90,242) |
(83,168) | |
| Amortization of other long- term assets |
49,849 | - | 149,545 | - | |
| Increase in deferred lease inducements |
- | - | 99,039 | - | |
| Dilution gain from Protiva Biotherapeutics Inc. | (386,231) |
(421,501) | (1,092,523) | (1,238,115) | |
| Equity in loss of Protiva Biotherapeutics Inc. |
386,231 | 421,501 | 1,092,523 | 1,238,115 | |
| Stock-based compensation expense |
466,872 | 612,693 | 1,464,345 | 1,725,497 | |
| Change in deferred revenue | - | - | 15,874,865 | - | |
| Net change in non-cash working capital |
(335,148) |
(836,169) | (3,600,348) | (3,687,185) | |
|
| |||||
| (6,287,350) | (8,541,271) | (5,556,629) | (27,546,605) | ||
|
| |||||
| INVESTMENTS | |||||
| Acquisition of property and equipment |
(170,627) | (72,252) | (1,161,137) | (439,692) | |
| Acquisition of medical technology |
(65,650) | - | (7,374,548) | - | |
| Acquisition of long-term assets |
- | - | (1,196,363) | - | |
| Sale (purchase) of short- term investments, net |
2,697,777 | 5,154,559 | (1,953,182) | 25,827,358 | |
|
| |||||
| 2,461,500 | 5,082,307 | (11,685,230) | 25,387,666 | ||
|
| |||||
| FINANCING | |||||
| Issuance of common shares pursuant to: | |||||
| Public offering, net of issue costs |
- | 25,558,645 | - | 25,558,645 | |
| Exercise of options | 66,326 | 64,473 |
758,743 | 455,975 | |
| Long-term debt, net of security deposit and financing costs |
- | - | 1,046,304 | - | |
| Repayment of long-term debt | (181,193) |
- | (442,986) | - | |
| Repayment of obligations under capital leases |
(44,727) |
(71,802) | (131,656) | (179,084) | |
|
| |||||
| (159,594) | 25,551,316 | 1,230,405 | 25,835,536 | ||
|
| |||||
| Net increase(decrease) in cash and cash equivalents | (3,985,444) | 22,092,352 | (16,011,454) | 23,676,597 | |
| Cash and cash equivalents, beginning of period |
34,081,744 |
33,864,606 | 46,107,754 | 32,280,361 | |
|
| |||||
| Cash and cash equivalents, end of period |
$30,096,300 | $55,956,958 | $30,096,300 | $55,956,958 | |
|
| |||||
| Supplemental cash flow information |
|||||
| Income taxes paid |
$- |
$- |
$- |
$- | |
| Interest paid |
$6,009 |
$10,704 |
$21,209 |
$29,974 | |
| Foreign exchange gain (loss) |
$(427,910) |
$113,208 |
$(338,086) |
$(741,872) | |
About Forward Looking Statements
There are forward-looking statements contained herein that are not based on historical fact, including without limitation statements containing the words “believes,” “may,” “plans,” “will,” “estimate,” “continue,” “anticipates,” “intends,” “expects,” and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, among others, INEX’s stage of development, lack of product revenues, additional capital requirements, risks associated with the completion of clinical trials and obtaining regulatory approval to market INEX’s products, the ability to protect its intellectual property and dependence on collaborative partners. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. The Company disclaims any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments.
INEX is a Canadian biopharmaceutical company developing and commercializing proprietary drugs and drug delivery systems to improve the treatment of cancer.
INEX investor contact:
Ian Mortimer
Senior Director, Investor Relations
Inex Pharmaceuticals Corporation
Tel: 604.419.3200
Email: info@inexpharm.com
Website: www.inexpharm.com
INEX media contact:
Miriam Zitner
James Hoggan & Associates Inc.
Tel: 604.739.7500
Email: mzitner@hoggan.com
INEX’s common shares are traded on the Toronto Stock Exchange under the trading symbol “IEX”.
