Arno Therapeutics Reports First Quarter 2016 Financial and Business Update

OREANDA-NEWS. May 17, 2016. Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company focused on the development of therapeutics for cancer and other life threatening diseases, today announced financial results for the quarter ended March 31, 2016 and provided an update on recent clinical developments for its lead compound, onapristone.  

Q1 2016 and Recent Highlights:

• Continued to actively enroll patients in the second stage of its Phase I/II trial of onapristone in men with advanced, castration-resistant prostate cancer (CRPC) who have failed treatment with abiraterone or enzalutamide. The Phase II portion of this study will evaluate onapristone in combination with Zytiga® (abiraterone acetate) in patients with CRPC.
• Formed Prostate Cancer Advisory Board chaired by Stuart Holden, MD, a Clinical Professor of Urology, Spielberg Family Chair in Urologic Oncology Associate Director, and Institute of Urologic Oncology at the UCLA David Geffen School of Medicine, to oversee the prostate study evaluating onapristone in combination with Zytiga® (abiraterone acetate) in patients with CRPC. 
• Executed strategic decision to focus its resources on its prostate cancer program and close the onapristone Phase II study of patients with recurrent or metastatic endometrioid cancer. The decision to close the Phase II endometrioid cancer study was not based on any safety or lack of efficacy signal and the Company will continue to provide onapristone to all patients currently enrolled in this trial on a compassionate use basis. 

“Based on emerging scientific evidence, we determined that the most effective clinical path forward was to focus on our CRPC program, as that was the indication for which onapristone held the greatest potential. Along with this strategic shift, we have formed a world-class Prostate Cancer Advisory Board, chaired by Dr. Stuart Holden, who is joined by a group of preeminent thought leaders in the genitourinary oncology/steroid receptor area. Our Phase I/II study of onapristone in men with advanced CRPC who have failed treatment with abiraterone or enzalutamide is progressing according to plan. We look forward to the advancement of the trial, including enrollment of additional subjects and bringing our U.S. sites on-board. We are confident that this is the right decision for the Company as it will allow us to concentrate our efforts and resources on a development program with significant potential.” said Alex Zukiwski, MD, Chief Executive Officer of Arno Therapeutics.

First Quarter 2016 Financial Results

For the three months ended March 31, 2016, Arno reported net loss of \\$3.7 million, or \\$0.10 per share, which includes non-cash expense of \\$0.9 million related to the increase in derivative liability of common stock warrants, and \\$0.9 million of non-cash stock based compensation expense.  Adjusting for these non-cash items, which resulted in an expense of \\$1.8 million, the Company reported a net loss of approximately \\$1.9 million, or \\$0.05 per share, on a non-GAAP basis.  Adjusted first quarter 2015 net loss was approximately \\$2.9 million, or \\$0.14 per share, on a non-GAAP basis, which includes the same non-cash adjustments as first quarter 2016. On a GAAP basis, first quarter 2015 net loss was \\$3.4 million, or \\$0.17 per share.

The primary factors for the \\$1.0 million year-over-year improvement in adjusted (non-GAAP) net loss in the first quarter of 2016 compared to the first quarter of 2015 were reduced spending on onapristone clinical trials of \\$0.6 million and lower compensation expense of \\$0.3 million.

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 potential of onapristone as a treatment of CRPC, statements regarding the timing, progress and anticipated results of the clinical development of 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 we will not obtain the capital necessary to fund our operations in a timely manner, if ever, or on acceptable terms, that if we are unable to obtain additional capital, we may be required to cease our ongoing clinical development activities, 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, that we will be able to successfully develop a diagnostic to identify APR tumors, 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, 2015 and in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2016. 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.