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May 12, 2015

Tokai Pharmaceuticals Reports First Quarter 2015 Financial Results

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 first quarter ended March 31, 2015.

“Throughout the first part of 2015 we have continued to see growing interest in AR-V7 and androgen receptor C-terminal loss as a resistance mechanism in prostate cancer. Final preparations are underway for the initiation of the ARMOR3-SV registration trial this quarter in patients with AR-V7 positive castration-resistant prostate cancer,” stated 

Jodie Morrison, President and Chief Executive Officer ofTokai Pharmaceuticals. “Data were also recently presented at AACR that demonstrated robust anti-tumor activity in pancreatic cancer models using both galeterone and novel androgen receptor degrading agents (ARDAs). These new data support potential utility beyond our lead prostate cancer indication and provide the first update of the ongoing efforts on our ARDA discovery platform. With $94.2 million in cash at the end of the quarter, we have the resources to take galeterone as a wholly-owned asset through topline ARMOR3-SV data anticipated by the end of 2016.”

Business Highlights

  • ARMOR3-SV Expected to Begin in 2Q 2015: Tokai plans to begin its ARMOR3-SV registration trial of galeterone in the second quarter of 2015, with topline data expected by the end of 2016. ARMOR3-SV is the Company’s planned Phase 3 clinical trial that will compare galeterone to Xtandi® (enzalutamide) in 148 metastatic CRPC treatment-naïve patients whose prostate tumors express the AR-V7 splice variant. The primary endpoint of the trial will be radiographic progression-free survival measured from the time of patient randomization to the time of radiographic evidence of disease progression or time of death from any cause.
  • Expanded Board of Directors: Since the beginning of 2015, Tokai announced the appointment of

    Cheryl Cohen, former Medivation Chief Commercial Officer, and 

    Stephen Buckley, Jr., former head of Ernst & Young’s Life Sciences Industry Practice of New England, to its Board of Directors.

  • Announced Preclinical Results from the University of Maryland Showing Galeteroneand Novel ARDA Compounds Inhibit Pancreatic Cancer Cell Growth: In April 2015, Tokaiannounced that scientists in the laboratory of Vincent Njar, PhD, at the University of Maryland School of Medicine presented preclinical data showing that galeterone and novel ARDA compounds inhibited the growth, survival and migration of human pancreatic ductal adenocarcinoma cells. These data were presented at the 2015American Association for Cancer Research (AACR) in Philadelphia, Pennsylvania.
  • Announced Expansion of the Collaboration with Qiagen for the Development of an AR-V7 Companion Diagnostic: In March 2015, Tokai announced an expansion to its agreement with Qiagenfor the development and commercialization of an AR-V7 companion diagnostic for use with galeterone. Development work for the AR-V7 clinical trial assay and companion diagnostic for use with galeterone has been underway since October 2014. Tokai expects that development of the AR-V7 clinical trial assay will be completed in the second quarter of 2015 prior to the start of the ARMOR3-SV registration clinical trial in AR-V7 positive metastatic castration-resistant prostate cancer patients. Under the expanded agreement, Tokai received the exclusive right from Qiagen to its acquired circulating tumor cell enrichment technology for use with galeterone which is being incorporated byQiagen into the clinical trial assay for the ARMOR3-SV trial.
  • Presented ARMOR3-SV Poster and Supported ASCO-GU CME Event: At the 2015 Genitourinary Cancers Symposium (ASCO-GU) on February 26-27, Tokai presented the protocol and rationale for the ARMOR3-SV Phase 3 trial and supported a CME event discussing AR-V7 in prostate cancer.

Financial Results

  • Cash and cash equivalents as of March 31, 2015 was $94.2 million compared to $105.3 million atDecember 31, 2014.
  • Research and development expenses were $10.6 million in the first quarter of 2015 compared to $3.6 million in the first quarter of 2014. Research and development expenses for the first quarter of 2015 includes increased costs related to manufacturing process optimization and validation studies for galeterone and the costs of developing our clinical trial assay for our ARMOR3-SV trial, including a one-time fee for the exclusive right from Qiagen to its CTC enrichment technology for use with galeterone.
  • General and administrative expenses were $2.7 million in the first quarter of 2015 compared to $1.3 million in the first quarter of 2014.
  • Net Loss was $13.3 million for the first quarter of March 31, 2015 compared to $4.8 million in the first quarter of 2014.

About Tokai Pharmaceuticals

Tokai Pharmaceuticals is a 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 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, 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 Administrationor 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 three months ended March 31, 2015. In addition, the forward-looking statements included in this press release represent the Company’s views as of May 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 toMay 12, 2015.

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