Full Press Release Details
Tokai Pharmaceuticals Reports Third Quarter 2014 Financial Results
Company Successfully Completed Initial Public Offering
CAMBRIDGE, Mass., November 10, 2014 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 ended September 30, 2014.
This has been an exciting year for Tokai, both operationally and in the clinic, stated Jodie Morrison, president and chief executive officer at
Tokai. We successfully completed our initial public offering, strengthened our balance sheet and made great progress with our lead product candidate, galeterone, for the potential treatment of patients with castration resistant prostate
cancer. Over the last year we have refined our initial registration strategy to focus on advancing galeterone into late-stage development in patients with androgen receptor splice variants that are expected to show poor response to currently
available secondary hormonal treatment options, with plans to initiate a pivotal Phase 3 clinical trial, ARMOR3-SV, in the first half of 2015. In addition, we committed to deepening our pipeline, including advancing our Androgen Receptor Degrading
Agents program. We look forward to reporting key updates on these efforts as we go forward.
Recent Business Highlights
About Tokai Pharmaceuticals
Tokai 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 (ARDA) 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, cash resources, financial position and projected costs, 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 the Company can establish companion diagnostics arrangements for its planned
Phase 3 trial; whether galeterone will advance through the clinical trial process on the anticipated timeline and warrant submission for regulatory approval; whether such a submission would receive approval from the United States Food and Drug
Administration or equivalent foreign regulatory agencies on a timely basis or at all; 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 Registration Statement on Form S-1. In addition, the forward-looking statements included in this press release represent the Company s views as of November 10, 2014. The Company anticipates that subsequent
events and developments will 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 November 10, 2014.
TOKAI PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share information)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
| Revenue | $ | $ | $ | $ | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 2,825 | 2,704 | 10,773 | 7,852 | ||||||||||||
| General and administrative | 3,599 | 661 | 6,428 | 2,348 | ||||||||||||
| Total operating expenses | 6,424 | 3,365 | 17,201 | 10,200 | ||||||||||||
| Loss from operations | (6,424 | ) | (3,365 | ) | (17,201 | ) | (10,200 | ) | ||||||||
| Other income (expense), net | 34 | 113 | ||||||||||||||
| Net loss | (6,390 | ) | (3,365 | ) | (17,088 | ) | (10,200 | ) | ||||||||
| Accretion of redeemable convertible preferred stock to redemption value | (79 | ) | ||||||||||||||
| Net loss attributable to common stockholders | (6,390 | ) | (3,365 | ) | (17,088 | ) | (10,279 | ) | ||||||||
| Basic and diluted net loss per share | $ | (2.71 | ) | $ | (6.82 | ) | $ | (15.19 | ) | $ | (26.36 | ) | ||||
| Basic and diluted weighted average number of common shares outstanding | 2,357,236 | 493,299 | 1,124,627 | 390,001 |
TOKAI PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEET DATA
| September 30, 2014 | December 31, 2013 | |||||||
| Cash and cash equivalents | $ | 105,464 | $ | 31,753 | ||||
| Total current assets | 106,724 | 32,178 | ||||||
| Working capital | 101,352 | 29,969 | ||||||
| Total assets | 106,983 | 32,287 | ||||||
| Total stockholders equity (deficit) | 101,611 | (55,267 | ) |
Lee Kalowski, Chief Financial Officer
Tokai Pharmaceuticals
Pure Communications, Inc.