RESEARCH TRIANGLE PARK, NORTH CAROLINA–(Marketwired – Mar 31, 2014) – Adherex Technologies Inc. (AHX.TO)(ADHXF), today reported its financial results and recent developments for the year ended December 31, 2013. All amounts are in US dollars unless otherwise specified.
The two Phase 3 clinical trials studying Sodium Thiosulfate (STS) for prevention of hearing loss in children receiving cisplatin chemotherapy have progressed well. The US based Children Oncology Group (COG) ACCL0431 study completed enrollment in February 2012. Final data is expected to be released by COG during American Society of Clinical Oncology (ASCO) meeting in June 2014. The enrollment of the European based SIOPEL 6 Study is almost complete, as 96 out of planned 102 patients have been randomized. The first three interim safety analyses were conducted after 20, 40 and 60 patients, and in each case, the Independent Data Monitoring Committee (IDMC) has recommended continuation of the study. An additional interim safety analysis for 80 patients is also expected to be performed shortly. Safety review data from this study have been submitted for presentation at ASCO in June 2014.
“We are encouraged by the recent strong patient participation in SIOPEL 6 and the continued recommendation by the IDMC that the study continue. In the event, that data from COG and SIOPEL show compelling results, Adherex plans to discuss the regulatory filing strategy for a New Drug Application (NDA) with the FDA during the second half of 2014” stated Mr. Rosty Raykov, Chief Executive Officer of Adherex.
Financial Update
The Company reported a net loss from operations of $0.4 million which excludes a $1.5 million non-cash gain on derivatives for the fourth quarter ended December 31, 2013, compared to a net loss from operations of $1.1 million excluding the non-cash loss of $5.4 million in the same period 2012. The decrease in the net loss from operations excluding the non-cash impact of derivatives is primarily due to a decrease in research and development expenses associated with the Company’s Phase II eniluracil trial.
Research and development expenses totaled $0.09 million for the fourth quarter ended December 31, 2013, as compared to a $0.6 million in the same period in 2012. There was a significant decrease in research and development expenses relating to the conclusion of enrollment and ongoing clinical support of the Phase II eniluracil trial. General and administrative expenses were $0.3 million in the fourth quarter ended December 31, 2013, as compared to $0.6 million in the same period in 2012.
The Company reported a net loss from operations of $1.9 million excluding the $3.8 million non-cash gain on derivatives for the twelve month period ended December 31, 2013, compared to a net loss from operations of $3.6 million excluding the non-cash loss of $1.6 million in the same period in 2012. The decrease in the net loss from operations excluding the non-cash impact of derivatives is primarily due to a decrease in research and development expenses associated with the Company Phase II eniluracil trial and a decrease in general and administrative expenses.
Research and development expenses totaled $0.6 million for the twelve month period ended December 31, 2013, as compared to $2.1 million in the same period in 2012. The decrease in research and development expenses relates to the wind down of the Phase II eniluracil trial which completed enrollment in December 2012 and the settlement of a debt in the third quarter of 2013 for less than what it was recorded at.
Cash and cash equivalents totaled $1.7 million at December 31, 2013, compared to $2.3 million at December 31, 2012. At December 31, 2013, the Company had working capital totaling approximately $1.4 million. The decreased cash balance is a result of the Company’s operating expenses relating to the Phase II eniluracil study, the ongoing support of the two Phase III studies of STS and general and administrative expenses. The decrease was offset by the cash proceeds from the Company’s private placement in November of 2013.
The selected financial data presented below is derived from our audited consolidated financial statements which were prepared in accordance with U.S. generally accepted accounting principles. The complete interim consolidated financial statements for the period ended December 31, 2013 and management’s discussion and analysis of financial condition and results of operations will be available at www.sec.gov and www.sedar.com.
| Adherex Technologies Inc. | ||||
| Selected Financial Data | ||||
| (U.S. Dollars in thousands except per share amounts) | ||||
| December 31, | December 31, | |||
| 2013 | 2012 | |||
| Interim Consolidated Balance Sheets: | ||||
| Assets: | ||||
| Cash and cash equivalents | 1,663 | 2,303 | ||
| Other current assets | 89 | 62 | ||
| Total assets | 1,752 | 2,365 | ||
| Liabilities and stockholders’ equity: | ||||
| Current liabilities | 344 | 682 | ||
| Derivative liabilities | 2,863 | 6,640 | ||
| Other long-term liabilities | – | – | ||
| Total stockholders’ equity | (1,455) | (4,957) | ||
| Total liabilities and stockholders’ equity (deficiency) | 1,752 | 2,365 | ||
| Interim Consolidated | Three Months Ended | Twelve Months Ended | |||||||
| Statements of Operations: | December | December | December | December | |||||
| 30, 2013 | 31, 2012 | 30, 2013 | 31, 2012 | ||||||
| Revenue | $ – | $ – | $ – | $ – | |||||
| Operating expenses | |||||||||
| Research and development | 90 | 561 | 597 | 2,075 | |||||
| General and administrative | 326 | 562 | 1,334 | 1,545 | |||||
| Loss from operations | (416) | (1,123) | (1,931) | (3,620) | |||||
| Unrealized gain (loss) | 1,524 | (5,395) | 3,777) | (1,563) | |||||
| Interest income and other | 3 | 7 | (1) | 20 | |||||
| Net income/(loss) and comprehensive income/(loss) | $ 1,111 | $ (6,511) | $ 1,845 | $ (5,163) | |||||
| Basic and diluted net loss per common share | $ 0.04 | $ (0.03) | $ 0.06 | $ (0.21) | |||||
Except for historical information described in this press release, all other statements are forward-looking. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including such risks that regulatory and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company’s products will not be as large as expected, the Company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, the Company may not meet its future capital requirements in different countries and municipalities, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2013. Adherex Technologies, Inc. disclaims any obligation to update these forward-looking statements except as required by law.
For a more detailed discussion of related risk factors, please refer to our public filings available at www.sec.gov andwww.sedar.com.
About Sodium Thiosulfate (STS)
STS is a chemoprotectant being developed by Adherex to reduce or prevent hearing loss in oncology patients resulting from treatment with platinum-based chemotherapy drugs. The initial focus is on the pediatric market. Hearing loss following cisplatin exposure affect approximately 2,000 children in the US every year. STS has received Orphan Drug Designation in the United States for the prevention of platinum-based ototoxicity in pediatric patients. In addition, Adherex has licensed intellectual property rights for the use of STS as a chemoprotectant from Oregon Health & Science University.
STS is a water-soluable thiol compound and acts as a chemical reducing agent. It is FDA approved for the treatment of cyanide poisoning and has been used in oncology to prevent cisplatin nephrotoxicity. It is thought that hearing loss caused by platinum compounds result from the deposition of protein-bound platinum in the cochlea and STS binds platinum/protein complexes thereby potentially minimizing their toxicity. At a bolus dose of 20 g/m2 over 15 minutes, STS has sufficient high plasma concentrations to rapidly, covalently bind to any residual extracellular cisplatin and thereby possibly prevent ototoxicity. Because STS is to be administered six hours after cisplatin, antitumor efficacy of cisplatin should not be compromised.
About STS Clinical Studies
Study ACCL0431: “A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children”, conducted by the Children’s Oncology Group (COG), finished enrollment of 135 patients in Q1 2012. These patients had been previously diagnosed with one of five rare childhood cancers typically treated with intensive cisplatin therapy, including hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma.
SIOPEL 6: “A Multicenter Open Label Randomized Phase III Trial of the Efficacy of Sodium Thiosulfate in Reducing Ototoxicity in Patients Receiving Cisplatin Chemotherapy for Standard Risk Hepatoblastoma” is being conducted by The International Childhood Liver Tumor Strategy Group, SIOPEL. As of this date, the study has enrolled 96 out of the planned 102 patients. SIOPEL 6 is studying STS in standard risk hepatoblastoma patients where the effectiveness of the platinum treatment is known to be very high.
For further information, please contact:
Rosty Raykov
Chief Executive Officer
Adherex Technologies Inc.
T: (919) 636-5144