Arno Therapeutics Reports First Quarter 2014 Financial and Business Update

FLEMINGTON, N.J., May 15, 2014 (GLOBE NEWSWIRE) -- Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, today announced financial results for the first quarter of 2014. For the three months ended March 31, 2014, Arno reported a net loss of $0.4 million, or $0.02 per share, which includes non-cash income of $5.7 million for the decrease in derivative liability of stock warrants, and $1.2 million of non-cash stock based compensation expense. Adjusting for these non-cash items, which totaled $4.5 million, the Company realized a net loss of approximately $5.0 million, or $0.24 per share on a non-GAAP basis. This compares to first quarter 2013 net loss of $0.9 million, or $0.21 per share on a GAAP basis, and adjusted first quarter 2013 net loss of approximately $3.4 million, or $0.75 per share on a non-GAAP basis, when considering the same non-cash adjustments plus $2.1 million related to non-cash interest expense from debentures that were converted into common stock in 2013.

The primary factor for the $1.6 million increase in adjusted (non-GAAP) net loss between the periods was increased R&D expenses, primarily associated with the initiation of two Phase I clinical trials for Arno's lead compound, onapristone, which occurred in the first quarter of 2014.

First Quarter 2014 and Recent Highlights:

• Enrolling patients in a Phase I dose escalation study evaluating onapristone in post-menopausal women with progesterone receptor (PR) positive tumors, including breast, endometrial and other solid tumors;
• In April 2014, began enrolling patients in a Phase I trial of onapristone in men with advanced, castration resistant prostate cancer who have failed treatment with abiraterone or enzalutamide;
• Entered into a co-development agreement with Leica Biosystems for the development of a companion diagnostic to identify patients who express a specific biomarker and are therefore more likely to respond to treatment with onapristone;
• Acquired a license from the University of Minnesota for a diagnostic technique to potentially identify patients more likely to benefit from treatment with onapristone; and
• Expanded management team through strategic appointments including Chief Financial Officer, VP of Diagnostics, VP of Clinical Operations and Project Management; named Randy Thurman, a member of Arno's Board of Directors, to the newly created role of Vice Chairman of the Board.

"The first several months of 2014 have been highly productive for Arno. Our accomplishments in the first quarter have positioned the Company to continue advancing Arno's lead compound, onapristone, while setting the stage for additional milestones as the year progresses," said Glenn Mattes, President and CEO of Arno Therapeutics. "In January, we completed an important step in our clinical development program by enrolling the first patient in our Phase I trial in France to evaluate onapristone in post-menopausal women with PR positive tumors. There are now seven sites in France actively enrolling patients, and we continue to expect that the study will be fully enrolled in 2014. Additionally, during the quarter we were able to enter into two key relationships that we expect will further enhance our ability to identify and treat those patients most likely to benefit from onapristone therapy through the development of diagnostic solutions."

Mr. Mattes added, "The momentum that began in the first quarter has carried over into the second quarter, as we began active enrollment in early April of patients in our Phase I trial of onapristone in men with advanced castration-resistant prostate cancer who have failed treatment with abiraterone or enzalutamide. In addition, we presented new data at the American Association of Cancer Research annual meeting in April and had two posters accepted for presentation at the American Society of Clinical Oncology annual meeting in June. These are two of the preeminent scientific meetings in oncology and we are honored to present this data to an audience that includes the leading authorities in the field. Overall, we believe we are well-positioned to continue executing on our clinical development strategy to support long-term success and value creation for our stakeholders. We believe we have the right strategy, the right resources and most importantly, the right team to achieve our strategic objectives, and we look forward to sharing additional milestones with the investment community as we move ahead."

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. Arno has exclusive worldwide rights to develop and market three innovative anti-cancer product candidates. These compounds are in clinical or preclinical development as product candidates to treat hematologic malignancies and solid tumors. 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, 2013. 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.