CAMBRIDGE, Mass., Nov. 19, 2018 (GLOBE NEWSWIRE) -- Anchiano Therapeutics (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 ended September 30, 2018 and provided a corporate update.
“We continue to make progress with our pivotal study of inodiftagene vixteplasmid as a treatment for non-muscle invasive bladder cancer and look forward to initiating the trial before the end of this year,” stated Frank Haluska, M.D., Ph.D., President and Chief Executive Officer of Anchiano. “Our balance sheet is strong after closing a private equity placement of $22.9M last quarter, and we believe we are well positioned to advance our pipeline.”
2018 Third Quarter Results and Financial Highlights
- Cash Position: Cash and cash equivalents were $10.9 million as of September 30, 2018, compared to $3.3 million as of September 30, 2017. Net cash used in operating activities for the three months ended September 30, 2018 was $6.6 million, compared to $1.4 million for the same period in 2017. Anchiano 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 September 30, 2018 were $2.5 million, which consisted of $1.4 million of research and development (R&D) expenses and $1.1 million of general and administrative (G&A) expenses.
- Net Loss: Net loss for the three months ended September 30, 2018 was $2.6 million, or $0.17 per share, compared to $1.9 million for the three months ended September 30, 2017, or $0.20 per share.
Upcoming Milestones:
- Initiating enrollment of patients into the first of two registrational clinical trials of inodiftagene vixteplasmid in early-stage bladder cancer before the end of 2018.
About Anchiano Therapeutics
Anchiano Therapeutics 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 non-muscle invasive bladder cancer. For additional information on inodiftagene vixteplasmid and the Codex Trial please go to www.anchiano.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 Anchiano Therapeutics 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, 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@anchiano.com
Investor Contact:
Ashley R. Robinson
Managing Director
LifeSci Advisors, LLC
617-535-7752
arr@lifesciadvisors.com
| Condensed Consolidated Interim Statements of Financial Position (unaudited) as at | ||||||||
| $ thousands | ||||||||
| September 30, 2018 | September 30, 2017 | December 31, 2017 | ||||||
| Current assets | ||||||||
| Cash and cash equivalents | 10,912 | 3,336 | 1,454 | |||||
| Receivables | 3,009 | 433 | 400 | |||||
| Total current assets | 13,921 | 3,769 | 1,854 | |||||
| Non-current assets | ||||||||
| Long-term prepaid expenses | 808 | 7 | 11 | |||||
| Long-term pledged deposits | 124 | - | - | |||||
| Asset for employee benefits, net | 3 | 3 | 3 | |||||
| Fixed assets, net | 347 | 223 | 219 | |||||
| Total non-current assets | 1,282 | 233 | 233 | |||||
| Total assets | 15,203 | 4,002 | 2,087 | |||||
| Current liabilities | ||||||||
| Trade payables | 808 | 177 | 160 | |||||
| Other payables | 1,608 | 2,542 | 2,381 | |||||
| Short-term employee benefits | 539 | 164 | 155 | |||||
| Derivative instruments | 7,005 | - | - | |||||
| Total current liabilities | 9,960 | 2,883 | 2,696 | |||||
| Non-current liabilities | ||||||||
| Derivative instruments | 5,010 | - | - | |||||
| Total non-current liabilities | ||||||||
| Total liabilities | 14,970 | 2,883 | 2,696 | |||||
| Equity | ||||||||
| Share capital* | - | - | - | |||||
| Additional paid-in capital | 70,469 | 60,035 | 60,043 | |||||
| Capital reserve from share-based payments | 3,328 | 517 | 1,767 | |||||
| Currency translation differences reserve | 782 | 1,495 | 457 | |||||
| Accumulated loss | (74,346 | ) | (60,928 | ) | (62,876 | ) | ||
| Total equity (deficiency) | 233 | 1,119 | (609 | ) | ||||
| Total liabilities and equity | 15,203 | 4,002 | 2,087 | |||||
| Condensed Consolidated Interim Statements of Operations (unaudited) |
$ thousands (other than per share amounts) |
| For the nine-month period ended | For the three-month period ended | Year ended | ||||||||||||
| September 30, | September 30, | September 30, | September 30, | December 31, | ||||||||||
| 2018 | 2017 | 2018 | 2017 | 2017 | ||||||||||
| Research and development expenses | 5,722 | 5,222 | 1,372 | 1,125 | 6,229 | |||||||||
| General and administrative expenses | 4,346 | 2,288 | 1,133 | 777 | 3,163 | |||||||||
| Operating loss | 10,068 | 7,510 | 2,505 | 1,902 | 9,392 | |||||||||
| Financing income | (12 | ) | (38 | ) | (12 | ) | (36 | ) | (1 | ) | ||||
| Financing expense | 953 | 176 | 72 | 2 | 92 | |||||||||
| Financing expense (income), net | 941 | 138 | 60 | (34 | ) | 91 | ||||||||
| Loss before taxes on income | 11,009 | 7,648 | 2,565 | 1,868 | 9,483 | |||||||||
| Income tax | 461 | 210 | 68 | 57 | 323 | |||||||||
| Net loss for the period | 11,470 | 7,858 | 2,633 | 1,925 | 9,806 | |||||||||
| Loss per share (in $): | ||||||||||||||
| Basic and diluted loss | 0.98 | 0.89 | 0.17 | 0.2 | 1.09 | |||||||||
| Number of shares used to compute basic and diluted loss per share (thousands of shares) | 11,666 | 8,816 | 15,574 | 9,539 | 9,025 | |||||||||