CAMBRIDGE, Mass., May 15, 2018 – BioCanCell Ltd. (TASE: BICL), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapies to treat cancer, today announced operating and financial results for the first quarter ending March 31, 2018 and provided a corporate update.
“The first quarter was marked by meaningful activity for the company. We presented our final data from the Phase 2 study of BC-819 in early stage bladder cancer and are preparing now to initiate our Phase 2 pivotal study,” stated Frank Haluska, M.D., Ph.D., chief executive officer of BioCanCell. “Our balance sheet is strong as we prepare to close a private equity offering, and we are well-positioned to advance our first-in-class gene therapy into the first of two registrational trials in the second half of this year.”
• Presented final data from the Phase 2 study of BC-819 for early stage bladder cancer at the 2018 ASCO Genitourinary Cancers Symposium demonstrating meaningful activity
• Announced two new key hires to the clinical team: Ronald Knickerbocker, Ph.D. named Senior Vice President of Clinical Development and Data Sciences, and Sean Daly named Vice President of Clinical Operations
• Raised $22.8 million in a private equity investment (PIPE) financing, led by Shavit Capital and included new and existing U.S. and Israeli investors. Net proceeds of the PIPE are earmarked to advance the Company’s drug development programs, including the initiation of a pivotal trial of its first-in-class and first-of-its-kind gene therapy for bladder cancer
• Anticipate initiating enrollment of patients into the first of two registrational clinical trials of BC-819 in early-stage bladder cancer in the second half of 2018
2018 First Quarter Results and Financial Highlights:
• Cash Position: Cash and cash equivalents were $0.67 million as of March 31, 2018 prior to receiving the PIPE funding, compared to cash and cash equivalents of $3.56 million as of March 31, 2017. Net cash used in operating activities for the three months ended March 31, 2018 was $2.65 million, compared to $1.18 million for the same period in 2017. BioCanCell anticipates that once the PIPE is closed, its 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 March 31, 2018 were $3.36 million, which consisted of $2.45 million of research and development (R&D) expenses and $0.91 million of general and administrative (G&A) expenses.
• Net Loss: The Company’s net loss for the three months ended March 31, 2018 was $3.50 million, or $0.13 per share, compared to $2.41 million for the three months ended March 31, 2017, or $0.11 per share.
This press release is neither an offer to sell, nor a solicitation of an offer to buy, any securities, and shall not constitute an offer to buy or a sale of securities in any jurisdiction in which such offer, solicitation or sale is unlawful.
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, 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 BC-819, 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.
Frank Haluska, M.D., Ph.D.
President and Chief Executive Officer
Ashley R. Robinson
LifeSci Advisors, LLC