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`Tokai Pharmaceuticals Announces Clinical Update
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`July 26, 2016 7:01 AM ET
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`Company to Discontinue Phase 3 ARMOR3-SV Trial of Galeterone in AR-V7 Positive mCRPC
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`Tokai to Host Conference Call Today at 8:30 AM E.T.
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`BOSTON--(BUSINESS WIRE)--Jul. 26, 2016-- Tokai Pharmaceuticals Inc.(cid:160)(NASDAQ:TKAI), a biopharmaceutical
`company focused on developing and commercializing innovative therapies for prostate cancer and other hormonally driven
`diseases, today announced that it plans to discontinue the ARMOR3-SV clinical trial, the company’s pivotal Phase 3
`study comparing galeterone to enzalutamide in treatment-naïve metastatic castration-resistant prostate cancer (mCRPC)
`patients whose prostate tumors express AR-V7, following the recommendation made yesterday by the trial’s independent
`Data Monitoring Committee (DMC).
`
`Based on a review of all safety and efficacy data, the DMC determined that the ARMOR3-SV trial will likely not succeed
`in meeting its primary endpoint of demonstrating an improvement in radiographic progression-free survival (rPFS) for
`galeterone versus enzalutamide in AR-V7 positive mCRPC. In making its recommendation, the DMC did not cite any
`safety concerns with galeterone in the trial. ARMOR3-SV is the first pivotal clinical trial in mCRPC to prospectively
`select AR-V7 positive patients, a population with an unmet medical need and aggressive disease course. The company
`plans to present data from the trial in a scientific forum once fully available and analyzed.
`
`“We are very disappointed by this outcome. An immediate priority is to analyze the unblinded study data in detail as we
`evaluate potential paths forward for galeterone and our pipeline,” said Jodie Morrison, President and Chief Executive
`Officer of Tokai. “We are deeply grateful for the support and commitment from the patients participating in the study,
`their caregivers, and the study investigators and their staff.”
`
`The company intends to evaluate its ongoing ARMOR2 expansion in mCRPC patients with acquired resistance to
`enzalutamide, and the planned study in patients who rapidly progress on either enzalutamide or abiraterone acetate. Tokai
`plans to allow all patients currently enrolled in the ARMOR2 and ARMOR3-SV trials to continue on therapy following
`consultation with their physicians and study investigators. The appropriate health authorities and clinical study
`investigators are being notified that ARMOR3-SV is being discontinued.
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`As of June 30, 2016, Tokai had approximately $43.9M in cash and cash equivalents.
`
`Conference Call Information
`Tokai will host an update conference call today, July 26th, at 8:30 AM E.T. The call can be accessed by dialing (844)
`243-9273 (U.S. and Canada) or (225) 283-0389 (international) and entering passcode 56339813. To access the live audio
`webcast, or the subsequent archived recording, visit the “Investors and Media – Calendar of Events” section of the Tokai
`website at www.tokaipharmaceuticals.com. The webcast will be recorded and available for replay on the company’s
`website for two weeks.
`
`About ARMOR3-SV
`ARMOR3-SV was a pivotal Phase 3 trial comparing galeterone to Xtandi® (enzalutamide) in mCRPC treatment-naïve
`patients whose prostate tumors express the AR-V7 splice variant. These truncated ARs are missing the C-terminal end of
`the AR that contains the ligand-binding domain, which is known as C-terminal loss. AR-V7 is the most common form of
`C-terminal loss. The trial employed a precision medicine approach for selection of patients with the AR-V7 splice variant
`by using an AR-V7 clinical trial assay successfully optimized for global use by Qiagen. The primary endpoint of
`ARMOR3-SV was radiographic progression-free survival assessed by blinded independent central review.
`
`About Galeterone
`Galeterone is an oral small molecule that utilizes the mechanistic pathways of current second-generation hormonal
`
`
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`JANSSEN EXHIBIT 2073
`Wockhardt v. Janssen IPR2016-01582
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`therapies, including abiraterone and enzalutamide, while also introducing a unique third mechanism – androgen receptor
`degradation – that impairs the function of androgen receptors, decreasing their sensitivity to androgen activity and
`reducing tumor growth. Tokai is developing galeterone for the treatment of patients with metastatic castration-resistant
`prostate cancer. Tokai has worldwide development and commercialization rights to galeterone.
`
`About Tokai Pharmaceuticals
`Tokai Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapies
`for prostate cancer and other hormonally driven diseases. The company’s lead drug candidate, galeterone, is an oral small
`molecule that utilizes the mechanistic pathways of current second-generation hormonal therapies, while also introducing a
`unique third mechanism – androgen receptor degradation. Tokai is developing galeterone for the treatment of patients with
`metastatic castration-resistant prostate cancer. The company also has a cancer discovery program focused on compounds
`that potently and selectively degrade the androgen receptor. For more information on the company, please visit
`www.tokaipharmaceuticals.com.
`
`Forward-looking Statements
`Any statements in this press release about our future expectations, plans and prospects, including statements about our
`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 our cash resources will be sufficient to fund
`our continuing operations for the period anticipated; whether, if we determine to move forward with the development of
`galeterone, necessary regulatory and ethics approvals to commence additional clinical trials for galeterone can be obtained,
`data from early clinical trials of galeterone will be indicative of the data that will be obtained from future clinical trials;
`whether the results of clinical trials will warrant submission for regulatory approval of galeterone, any such submission
`will receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies and,
`if galeterone obtains such approval, it will be successfully distributed and marketed; and other factors discussed in the
`“Risk Factors” section of our annual report on Form 10-K for the year ended December 31, 2015. Any forward-looking
`statements contained in this press release speak only as of the date hereof and not of any future date, and we expressly
`disclaim any obligation to update any forward-looking statements, whether as a result of new information, future events or
`otherwise.
`
`View source version on businesswire.com: http://www.businesswire.com/news/home/20160726005553/en/
`
`Source: Tokai Pharmaceuticals Inc.
`
`Investors:
`Tokai Pharmaceuticals Inc.
`Lee Kalowski, 617-225-4305
`Chief Financial Officer
`lkalowski@tokaipharma.com
`or
`Argot Partners
`David Pitts/Maeve Conneighton, 212-600-1902
`david@argotpartners.com
`maeve@argotpartners.com
`or
`Media:
`Ten Bridge Communications
`Lynnea Olivarez, 956-330-1917
`lynnea@tenbridgecommunications.com
`
`