Adherex Technologies Inc.
TSX : AHX
AMEX : ADH

Adherex Technologies Inc.

August 13, 2008 08:30 ET

Adherex Reports Second Quarter 2008 Financial Results

RESEARCH TRIANGLE PARK, NORTH CAROLINA--(Marketwire - Aug. 13, 2008) - Adherex Technologies Inc. (TSX:AHX)(AMEX:ADH), a biopharmaceutical company dedicated to solving problems for patients with cancer, today reported its financial results for the second quarter ended June 30, 2008. All amounts are in U.S. dollars.

Financial Update

The net loss for the quarter ended June 30, 2008 was $3.4 million, or a loss of $0.03 per share, compared to a net loss of $3.2 million, or a loss of $0.03 per share, for the quarter ended June 30, 2007. Operating expenses for the quarter ended June 30, 2008 totaled $3.5 million as compared to $3.4 million in the same period in 2007.

The net loss for the six-month period ended June 30, 2008 was $7.7 million, or a loss of $0.06 per share, compared to a net loss of $7.1 million, or a loss of $0.07 per share, for the six-month period ended June 30, 2007.

Cash and cash equivalents totaled $10.4 million as of June 30, 2008, compared to $16.2 million as of December 31, 2007, with a corresponding decrease in working capital of $5.9 million. The decreased cash balance reflects expenditures used to fund operations. The Company believes that it has sufficient capital resources to fund operations through June 30, 2009.

Corporate Update

The following is an update on our programs for the quarter ended June 30, 2008:

- In April, we completed patient enrollment in our Phase I study of ADH-1 in combination with three separate chemotherapies, ADH-1 + docetaxel (Taxotere®), ADH-1 + carboplatin, and ADH-1 + capecitabine (Xeloda®). This trial enrolled a total of 39 patients and we are in the process of evaluating the full dataset for presentation at a later date.

- In May, we completed a license agreement with the Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NCI-AVL) for the exclusive use of data from a completed Phase III trial using sodium thiosulfate (STS) to prevent platinum-induced hearing loss in adults with head and neck cancer. The NCI-AVL Phase III trial demonstrated that, at two years following treatment, STS was able to protect against cisplatin-induced hearing loss without any apparent affect on the anti-cancer treatment efficacy of the cisplatin. The agreement with NCI-AVL also includes an exclusive license to data from a planned follow-up study intended to provide longer-term data on the hearing status, disease-free status and overall survival of patients from the completed Phase III trial. Long term follow-up data on these patients may provide valuable information about the ability of STS to provide a long term benefit for the patients and ultimately facilitate regulatory applications. STS is also currently being studied in two international Phase III trials, one with the International Childhood Liver Tumour Strategy Group, also known as SIOPEL, and the other with the Children's Oncology Group (COG). Both the SIOPEL and COG studies are exploring the safety and efficacy of STS as a hearing protectant in children during platinum-based chemotherapy. We expect the SIOPEL study to enroll approximately 100 pediatric patients in up to 33 countries and the COG study to enroll up to 120 pediatric patients in up to 230 COG centers. We also have plans to initiate a further Phase III trial with STS in adult head and neck cancer patients in the U.S. later this year.

- In June, at the 2008 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, we presented interim results from our Phase I/II study of ADH-1 in combination with isolated limb infusion melphalan for the treatment of melanoma. Data was presented in a poster presentation on the first 16 patients in the Phase I/II trial, six patients from the completed Phase I portion of the trial and 10 patients from the ongoing Phase II portion of the trial. The Phase I/II study is expected to accrue up to 56 patients. Currently, we have enrolled a total of 37 patients and expect to complete patient enrollment in the second half of 2008. The additional patient enrollment is expected to provide a more robust estimate of the response rate, and provide ancillary information potentially valuable for the design and conduct of a prospective, randomized trial.

- Eniluracil has continued to enroll patients in the Phase I and Phase I/II trials intended to determine the maximum tolerated dose (MTD) of oral 5-FU in combination with eniluracil. We have not determined the appropriate dose and schedule for our Phase II studies. Certain dose limiting toxicity was seen at a single dose of eniluracil and 5-FU. We also found that the duration of DPD inhibition following the single dose of eniluracil would permit the administration of multiple doses of 5-FU over several days. We have therefore amended the study to split the total dose of 5-FU over several days which may allow us to administer a higher dose of 5-FU over a more extended time frame which may enable enhanced antitumor activity with a satisfactory safety profile. This information is considered highly valuable for the planning and conduct of subsequent trials. The ongoing Phase I/II trial of eniluracil in combination with oral 5-FU in liver (hepatocellular) cancer will also be amended so that patients will receive a split dose of oral 5-FU as above. Once an MTD has been determined using the new schedule, we plan to commence a Phase II trial in breast cancer. To date, we have enrolled 38 patients in the Phase I trial and 7 patients in the Phase I/II trial and expect to complete patient enrollment in the Phase I study and the Phase I portion of the Phase I/II study by the end of this year.

The selected financial data presented below are derived from our interim unaudited consolidated financial statements for the period ended June 30, 2008 included on Form 10-Q, which is available on our website at www.adherex.com and also at www.sec.gov.


About Adherex Technologies

Adherex Technologies Inc. is a biopharmaceutical company dedicated to the discovery and development of novel cancer therapeutics. We are in the business of solving problems for patients with cancer. We have multiple products in the clinical stage of development, including eniluracil, ADH-1 and sodium thiosulfate (STS). Eniluracil, an oral dihydropyrimidine dehydrogenase (DPD) inhibitor, is being developed to improve the tolerability and effectiveness of 5-fluorouracil (5-FU), one of the most widely used oncology drugs in the world. ADH-1 is a biotechnology compound which selectively targets N-cadherin, a protein present on certain tumor cells and the blood vessels of solid tumors. STS is a chemoprotectant being developed to reduce or prevent hearing loss that may result from treatment with platinum-based chemotherapy drugs. With a diversified portfolio of unique preclinical and clinical-stage cancer compounds and a management team with expertise in identifying, developing and commercializing novel cancer therapeutics, Adherex aims to become a leader in developing innovative treatments that address important unmet medical needs in cancer. For more information, please visit our website at www.adherex.com.

FINANCIAL CHARTS FOLLOW



Adherex Technologies Inc.
Unaudited Selected Financial Data
(U.S. dollars in thousands except per share amounts)

June 30, December 31,
Condensed Consolidated Balance Sheets: 2008 2007
-------------------------------------------------------------------------
Assets:
Cash and cash equivalents $10,433 $16,217
Other current assets 268 344
Long-term assets 494 648
-------------------------------------------------------------------------
Total assets $11,195 $17,209
-------------------------------------------------------------------------
-------------------------------------------------------------------------

Liabilities and stockholders' equity:
Accounts payable and accrued liabilities $2,403 $2,402
Other long-term liabilities 616 659
Total stockholders' equity 8,176 14,148
-------------------------------------------------------------------------
Total liabilities and stockholders' equity $11,195 $17,209
-------------------------------------------------------------------------
-------------------------------------------------------------------------



Condensed Consolidated Statements of Operations:
Three Months Ended Six Months Ended
-------------------------------------------------------------------------
June 30, June 30, June 30, June 30,
2008 2007 2008 2007
-------------------------------------------------------------------------

Revenue $- $- $- $-

Operating expenses:
Research and
development 2,572 2,646 5,947 5,803
General and
administrative 939 793 2,000 1,751
-------------------------------------------------------------------------

Loss from operations (3,511) (3,439) (7,947) (7,554)
-------------------------------------------------------------------------

Interest income 69 260 201 407
-------------------------------------------------------------------------

Net loss and
comprehensive loss $(3,442) $(3,179) $(7,746) $(7,147)
-------------------------------------------------------------------------
-------------------------------------------------------------------------

Basic and diluted
net loss per common
share $(0.03) $(0.03) $(0.06) $(0.07)
-------------------------------------------------------------------------
-------------------------------------------------------------------------


This press release contains forward-looking statements that involve significant risks and uncertainties. The actual results, performance or achievements of the Company might differ materially from the results, performance or achievements of the Company expressed or implied by such forward-looking statements. Such forward-looking statements include, without limitation, those regarding our development plans and the expected timing and results of our development. We can provide no assurance that development will proceed as currently anticipated, that previous results will be predictive of future outcomes, or that the expected timing or results will be realized. We are subject to various risks, including the uncertainties of clinical trials, drug development and regulatory review, the early stage of our product candidates, our reliance on collaborative partners, our need for additional capital to fund our operations, our history of losses, and other risks inherent to the biopharmaceutical industry. For a more detailed discussion of related risk factors, please refer to our public filings available at www.sedar.com and www.sec.gov.

Contact Information

  • Adherex Technologies Inc.
    D. Scott Murray
    Senior Vice President, Corporate Development
    919-484-8484
    info@adherex.com