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March 31, 2015

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Arno Therapeutics Reports Fourth Quarter 2014 Financial and Business Update

FLEMINGTON, NJ - March 31, 2015 - Arno Therapeutics, Inc. (OTCQB: ARNI), a clinical stage biopharmaceutical company focused on the development therapeutics for cancer and other life threatening diseases, today announced financial results for the quarter and year ended December 31, 2014 and provided an update on recent clinical developments for its lead compound, onapristone.

2014 Highlights
  • Initiated a Phase II trial of onapristone in women with recurrent or metastatic endometrioid tumors that have been shown to express the activated form of the progesterone receptor (APR), and who have received no more than one prior chemotherapy and no prior hormone therapy;
  • Continued to actively enroll patients in Phase I/II trial of onapristone in men with advanced, castration resistant prostate cancer who have failed treatment with abiraterone or enzalutamide;
  • Presented encouraging preliminary data from Phase I clinical trial in women with progesterone receptor positive tumors, which showed no significant liver function test abnormalities observed related to onapristone ; and
  • Presented important data for onapristone and the related clinical diagnostic program at multiple scientific meetings (ASCO, AACR, SABCS).
"The initiation of patient screening for our Phase II study of onapristone in patients with APR positive endometrioid tumors in December was a critical step forward for Arno, as this represents patient population very similar to those that we intend to treat in our planned registration study," said Alex Zukiwski, MD, Chief Executive Officer of Arno Therapeutics. "Overall, in 2014, Arno made substantial progress in advancing the clinical development of onapristone. Our accomplishments position us well for similarly strong progress in 2015. We are now focused on completing enrollment of the Phase II study as expeditiously as possible so that we can move forward with the planned registration study in 2016."

Fourth Quarter 2014 Financial Results

For the three months ended December 31, 2014, Arno reported net income of $4.6 million, or $0.22 per share, which includes non-cash income of $8.4 million related to the decrease in derivative liability of common stock warrants, and $1.0 million of non-cash stock based compensation expense. Adjusting for these non-cash items, which resulted in a gain of $7.4 million, the Company reported a net loss of approximately $2.8 million, or $0.14 per share, on a non-GAAP basis. Adjusted fourth quarter 2013 net loss was approximately $5.4 million, or $0.34 per share, on a non-GAAP basis, which includes the same non-cash adjustments plus $12.7 million related to non-cash interest expense from debentures that were converted into common stock in 2013. On a GAAP basis, fourth quarter 2013 net loss was $23.7 million, or $1.51 per share.

The primary factor for the $2.5 million year-over-year improvement in adjusted (non-GAAP) net loss in the fourth quarter of 2014 compared to the fourth quarter of 2013 was reduced spending on non-clinical research and CMC activities in 2014 totaling $2.1 million.

For the year ended December 31, 2014, Arno reported net income of $7.8 million, or $0.38 per share, which includes non-cash income of $29.2 million for the decrease in derivative liability of common stock warrants, and $4.5 million of non-cash stock based compensation expense. Adjusting for these non-cash items, which resulted in a benefit of $24.7 million, net loss for the period was approximately $16.9 million, or $0.83 per share, on a non-GAAP basis. This compares to an adjusted non-GAAP net loss for 2013 of approximately $15.0 million, or $2.01 per share, when considering the same non-cash adjustments, plus $19.0 million related to non-cash interest expense from debentures that were converted into common stock in 2013, and a net loss of $39.7 million, or $5.28 per share, on a GAAP basis.

The $1.9 million increase in adjusted (non-GAAP) net loss for the full year 2014, was due to increased R&D expenses, primarily associated with the initiation in 2014 of the two Phase I/II clinical trials for onapristone.

Non-GAAP Measures

Arno believes it prepared its consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (GAAP) and pursuant to accounting requirements of the Securities and Exchange Commission. In an effort to provide investors with additional information regarding Arno's results and to provide a meaningful period-over-period comparison of Arno's financial performance, the Company sometimes uses non-GAAP financial measures as defined by the Securities and Exchange Commission. The differences between the GAAP and non-GAAP financial measures are reconciled in schedule below. In presenting comparable results, the Company discloses non-GAAP financial measures when it believes such measures will be useful to investors in evaluating Arno’s underlying business performance. Management uses the non-GAAP financial measures to evaluate Arno’s financial performance against internal budgets and targets. In addition, management internally reviews Arno’s results excluding the impact of certain items, as it believes that these non-GAAP financial measures are useful for evaluating Arno’s core operating results and facilitating comparison across reporting periods. Importantly, Arno believes non-GAAP financial measures should be considered in addition to, and not in lieu of, GAAP financial measures. Arno’s non-GAAP financial measures may be different from non-GAAP financial measures used by other companies.

About Onapristone

Onapristone has the potential to be the first approved anti-progestin for oncology indications and provide chemotherapy-sparing treatment to cancer patients who express a specific biomarker, as detected by a companion diagnostic under development. Onapristone is an oral, anti-progestin hormone blocker that has been shown in previous clinical trials to have anti-tumor activity in patients with breast cancer. Onapristone appears to have a unique ability to block the activation of the progesterone receptor, which is believed to be a mechanism that may inhibit the growth of breast, endometrial and other tumors. The activated form of the progesterone receptor (APR) has the potential to function as a biomarker of anti-progestin activity.

About Arno Therapeutics

Arno Therapeutics is a clinical stage biopharmaceutical company developing innovative products for the treatment of cancer and other life threatening diseases. Arno has exclusive worldwide rights to develop and market three innovative anti-cancer product candidates. These compounds are in clinical or preclinical development. For more information about the company, please visit www.arnothera.com.

Forward-Looking Statements: This press release contains forward-looking statements that involve substantial risks and uncertainties. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include, without limitation, statements regarding the timing, progress and anticipated results of the clinical development of onapristone, including the ability to identify and treat those patients most likely to benefit from onapristone, as well as Arno's strategy, future operations, outlook, milestones, future financial position, future financial results, plans and objectives. Arno may not actually achieve these plans, intentions or expectations and Arno cautions investors not to place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Various important factors could cause actual results or events to differ materially from the forward-looking statements that we make. Such factors include, among others, risks that the results of clinical trials will not support our claims or beliefs concerning the effectiveness of onapristone or any of our other product candidates, our ability to successfully develop a diagnostic to identify APR tumors, our ability to finance the development of our product candidates, regulatory risks, and our reliance on third party researchers and other collaborators. Additional risks are described in the company's Annual Report on Form 10-K for the year ended December 31, 2014. Arno is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.




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(646) 536-7014

Arno Therapeutics
Lawrence Kenyon
lk@arnothera.com
(862) 703-7171



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