Full Press Release Details
Tokai Pharmaceuticals Reports Fourth Quarter and Full Year 2014 Financial Results
CAMBRIDGE, Mass., March 12, 2015 Tokai Pharmaceuticals, Inc. (NASDAQ: TKAI), a clinical-stage biopharmaceutical company focused on
developing novel therapies for prostate cancer and other hormonally driven diseases, today reported company highlights and financial results for the quarter and year ended December 31, 2014.
We are excited by the recent heightened attention on AR-V7 in prostate cancer and interest in our ARMOR3-SV galeterone registration trial at the 2015
Genitourinary Cancers Symposium (ASCO-GU), stated Jodie Morrison, President and Chief Executive Officer of Tokai Pharmaceuticals. We remain on track to begin ARMOR3-SV in the first half of the year as we work to complete development of
our AR-V7 clinical trial assay and continue trial center start up. We ended 2014 with over $105 million in cash, which we expect will provide us with sufficient funding into 2017, enabling us to take galeterone as a wholly-owned worldwide asset
through topline data due by late 2016.
Recent Business Highlights
About Tokai Pharmaceuticals
Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing novel therapies for prostate cancer and other hormonally driven diseases. The company s lead drug candidate, galeterone, is a highly selective, multi-targeted,
oral small molecule drug candidate being developed for the treatment of patients with castration-resistant prostate cancer. The company s Androgen Receptor Degrading Agents drug discovery program is focused on the identification and evaluation
of compounds that are designed to disrupt androgen receptor signaling through enhanced androgen receptor degradation and are targeted to patients with androgen receptor signaling diseases, including prostate cancer. For more information on the
company and galeterone, please visit www.tokaipharma.com.
Forward-looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company s strategy,
future operations, intellectual property, and other statements containing the words believes, anticipates, plans, expects, and similar expressions, constitute forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether the Company s cash
resources will be sufficient to fund the Company s continuing operations for the period anticipated; whether data from early clinical trials will be indicative of the data that will be obtained from future clinical trials; whether galeterone
will advance through the clinical trial process on the anticipated timeline, including whether ARMOR3-SV will be initiated when anticipated; whether a companion diagnostic can be developed successfully and on a timely basis; whether the results of
ARMOR3-SV will warrant submission for regulatory approval of galeterone and whether such submission will receive approval
from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if galeterone obtains such approval, it will be successfully distributed and marketed; and
other factors discussed in the Risk Factors section of the Company s quarterly report on Form 10-Q for the quarter ended September 30, 2014. In addition, the forward-looking statements included in this press release represent
the Company s views as of March 12, 2015. The Company anticipates that subsequent events and developments may cause the Company s views to change. However, while the Company may elect to update these forward-looking statements at some
point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company s views as of any date subsequent to March 12, 2015.
TOKAI PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share information)
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
| Revenue | $ | $ | $ | $ | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 3,804 | 4,349 | 14,577 | 12,201 | ||||||||||||
| General and administrative | 2,457 | 1,200 | 8,885 | 3,548 | ||||||||||||
| Total operating expenses | 6,261 | 5,549 | 23,462 | 15,749 | ||||||||||||
| Loss from operations | (6,261 | ) | (5,549 | ) | (23,462 | ) | (15,749 | ) | ||||||||
| Other income | 53 | 24 | 166 | 24 | ||||||||||||
| Net loss | (6,208 | ) | (5,525 | ) | (23,296 | ) | (15,725 | ) | ||||||||
| Accretion of redeemable convertible preferred stock to redemption value | (15 | ) | (94 | ) | ||||||||||||
| Net loss attributable to common stockholders | $ | (6,208 | ) | $ | (5,540 | ) | $ | (23,296 | ) | $ | (15,819 | ) | ||||
| Basic and diluted net loss per share | $ | (0.28 | ) | $ | (11.23 | ) | $ | (3.60 | ) | $ | (38.02 | ) | ||||
| Basic and diluted weighted average number of common shares outstanding | 22,328,994 | 493,299 | 6,469,289 | 416,037 |
TOKAI PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEET DATA
| December 31, | ||||||||
| 2014 | 2013 | |||||||
| Cash and cash equivalents | $ | 105,256 | $ | 31,753 | ||||
| Total assets | 107,744 | 32,287 | ||||||
| Working capital | 103,268 | 29,969 | ||||||
| Redeemable convertible preferred stock | 85,345 | |||||||
| Total stockholders equity (deficit) | 103,501 | (55,267 | ) |
Lee Kalowski, Chief Financial Officer
Tokai Pharmaceuticals
Pure Communications, Inc.