CAMBRIDGE, Mass., Aug. 22, 2018 (GLOBE NEWSWIRE) -- BioCanCell Ltd. (TASE: ANCN), a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat cancer, today announced operating and financial results for the quarter ending June 30, 2018 and provided a corporate update.
“We continue to make progress in our plans to initiate our pivotal study of inodiftagene vixteplasmid as a treatment for non-muscle invasive bladder cancer and look forward to initiating the trial in the second half of this year,” stated Frank Haluska, M.D., Ph.D., President and Chief Executive Officer of BioCanCell. “Our balance sheet is strong after closing a private equity offering of $22.9M in the last quarter, and we are well positioned to advance our pipeline.”
2018 Second Quarter Results and Financial Highlights (*)
- Cash Position: Cash and cash equivalents were $19.5 million as of June 30, 2018, compared to cash and cash equivalents of $4.8 million as of June 30, 2017. Net cash used in operating activities for the three months ended June 30, 2018 was $1.9 million, compared to $4.1 million for the same period in 2017. BioCanCell anticipates that its existing cash and cash equivalents will enable it to fund its operating expenses and capital expenditure requirements into the second quarter of 2019.
- Operating Expenses: Total operating expenses for the three months ended June 30, 2018 were $4 million, which consisted of $1.8 million of research and development (R&D) expenses and $2.2 million of general and administrative (G&A) expenses.
- Net Loss: The Company’s net loss for the three months ended June 30, 2018 was $5.2 million, or $0.52 per share, compared to $3.6 million for the three months ended June 30, 2017, or $0.38 per share.
(*) The reported NIS figures as of June 30, 2018, have been presented in dollars, translated at the representative rate of exchange as of June 30, 2018 (NIS 3.65 = US$ 1.00).
Upcoming Milestones:
- Initiating enrollment of patients into the first of two registrational clinical trials of inodiftagene vixteplasmid in early-stage bladder cancer in the second half of 2018.
About BioCanCell
BioCanCell is a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat cancer, with offices in Cambridge, MA, and Jerusalem, Israel. The Company’s most advanced product candidate, inodiftagene vixteplasmid (BC-819), is in development as a treatment for early stage NMIBC. For additional information please go to www.biocancell.com.
Forward Looking Statements
This press release contains “forward-looking statements” that are subject to risks and uncertainties. These forward-looking statements include information about possible or assumed future results of clinical trials, the anticipated effects of receiving Fast Track designation, the anticipated timeframe for conducting additional clinical trials and making regulatory submissions, and other strategic and business plans and objectives. These forward-looking statements are based on information BioCanCell has when those statements are made or its management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. These risks and uncertainties include, but are not limited to: the success of the approach to discover and develop prospective therapeutic products, which is new and may never lead to marketable products; a lack of history of commercial sales; a dependence on the success of inodiftagene vixteplasmid, the development of which will require significant additional clinical testing before regulatory approval can be sought and commercial sales launched; a need to raise substantial additional funds to complete R&D activities; an ability to overcome scientific or technological difficulties that may be encountered and that may impede R&D activities; and an ability to obtain and maintain intellectual property protection for product candidates, including pursuant to licensed patents.
Company Contact:
Frank Haluska, M.D., Ph.D.
President and Chief Executive Officer
857-259-4622
info@biocancell.com
Investor Contact:
Ashley R. Robinson
Managing Director
LifeSci Advisors, LLC
617-535-7752
arr@lifesciadvisors.com
| Condensed Consolidated Interim Statements of Position as of |
| June 30, 2018 | June 30, 2017 | December 31, 2017 | ||||||
| (Unaudited) | (Unaudited) | (Audited) | ||||||
| NIS thousands | NIS thousands | NIS thousands | ||||||
| Current assets | ||||||||
| Cash and cash equivalents | 71,293 | 17,580 | 5,040 | |||||
| Receivables and other debit balances | 4,985 | 1,340 | 1,388 | |||||
| Total current assets | 76,278 | 18,920 | 6,428 | |||||
| Long-term prepaid expenses | 546 | 21 | 37 | |||||
| Long-term pledged deposits | 212 | - | - | |||||
| Asset in respect of employee benefits, net | 11 | 11 | 11 | |||||
| Property, plant and equipment, net | 992 | 746 | 760 | |||||
| Total non-current assets | 1,761 | 778 | 808 | |||||
| Total assets | 78,039 | 19,698 | 7,236 | |||||
| Current liabilities | ||||||||
| Trade payables | 10,887 | 720 | 559 | |||||
| Other payables and credit balances | 12,308 | 8,095 | 8,254 | |||||
| Short-term employee benefits | 1,616 | 745 | 536 | |||||
| Derivative instruments | 19,921 | - | - | |||||
| Total current liabilities | 44,732 | 9,560 | 9,349 | |||||
| Non-current liabilities | ||||||||
| Derivative instruments | 23,838 | - | - | |||||
| Total non-current liabilities | 23,838 | - | - | |||||
| Total liabilities | 68,570 | 9,560 | 9,349 | |||||
| Shareholders' equity | ||||||||
| Share capital | - | - | - | |||||
| Share premium | 266,921 | 228,840 | 228,893 | |||||
| Capital reserve for translation differences | 38 | (31 | ) | (133 | ) | |||
| Capital reserve for share-based payments | 11,695 | 5,699 | 7,183 | |||||
| Accumulated deficit | (269,185 | ) | (224,370 | ) | (238,056 | ) | ||
| Total shareholders' equity | 9,469 | 10,138 | (2,113 | ) | ||||
| Total liabilities and shareholders' equity | 78,039 | 19,698 | 7,236 | |||||
| BioCancell Ltd. | |||||||||||||||||
| Condensed Consolidated Interim Statements of Income | |||||||||||||||||
| For the 6-month period ended | For the 3-month period ended | Year ended | |||||||||||||||
| June 30, | June 30, | June 30, | June 30, | December 31, | |||||||||||||
| 2018 | 2017 | 2018 | 2017 | 2017 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | (Audited) | |||||||||||||
| NIS thousands | NIS thousands | NIS thousands | NIS thousands | NIS thousands | |||||||||||||
| Research and development expenses | 15,194 | 14,813 | 6,588 | 10,175 | 22,340 | ||||||||||||
| General and administrative expenses | 11,392 | 5,530 | 8,187 | 2,632 | 11,374 | ||||||||||||
| Operating loss | 26,586 | 20,343 | 14,775 | 12,807 | 33,714 | ||||||||||||
| Finance income | (1 | ) | (84 | ) | (1 | ) | (83 | ) | (5 | ) | |||||||
| Finance expense | 3,146 | 730 | 2,884 | 3 | 365 | ||||||||||||
| Finance expense (income), net | 3,145 | 646 | 2,883 | (80 | ) | 360 | |||||||||||
| Loss before taxes on income | 29,731 | 20,989 | 17,658 | 12,727 | 34,074 | ||||||||||||
| Taxes on income | 1,398 | 556 | 1,183 | 346 | 1,157 | ||||||||||||
| Loss for the period attributable to | |||||||||||||||||
| the shareholders of the Company | 31,129 | 21,545 | 18,841 | 13,073 | 35,231 | ||||||||||||
| Ordinary loss per share (in NIS): | |||||||||||||||||
| Basic and diluted loss | 3.2 | 2.6 | 1.9 | 1.4 | 3.9 | ||||||||||||
| Number of shares used to compute basic and diluted loss per share | |||||||||||||||||
| (thousands of shares) | 9,646 | 8,421 | 9,679 | 9,443 | 9,025 | ||||||||||||