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Arno Therapeutics Reports First Quarter 2015 Financial and Business Update

FLEMINGTON, N.J., May 15, 2015 (GLOBE NEWSWIRE) -- 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, 2015 and provided an update on recent clinical developments for its lead compound, onapristone.

First Quarter 2015 and Recent Highlights:

  • Announced data supporting the onapristone development program – including findings from a Phase I study in women with progesterone receptor (PR)-expressing tumors – that will be presented in three posters at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting;
  • Presented promising onapristone data in three posters at the 2015 American Association for Cancer Research (AACR) Annual Meeting;
  • Continued to actively screen patients for inclusion in 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; and
  • 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.

"The onapristone clinical development program continued to advance during the first quarter of 2015," said Alex Zukiwski, MD, Chief Executive Officer of Arno Therapeutics. "The investigators in our ongoing Phase II study in women with APR positive recurrent or metastatic endometrioid tumors are actively screening patients at 10 sites in France and we expect to add sites in the US soon. Upon successful completion of the Phase II study, our plans to initiate a registration study in 2016 remain on track. Additionally, our Phase I/II clinical trial in patients with advanced, castration resistant prostate cancer is expected to advance to the expansion phase within the next few months."

First Quarter 2015 Financial Results

For the three months ended March 31, 2015, Arno reported a net loss of $3.4 million, or $0.17 per share, which includes non-cash income of $0.4 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 $0.5 million, the Company reported a net loss of approximately $2.9 million, or $0.14 per share, on a non-GAAP basis. Adjusted first quarter 2014 net loss was approximately $5.0 million, or $0.24 per share, on a non-GAAP basis, which includes the same non-cash adjustments as first quarter 2015. On a GAAP basis, first quarter 2014 net loss was $0.4 million, or $0.21 per share.

The primary factor for the $2.1 million year-over-year improvement in adjusted (non-GAAP) net loss in the first quarter of 2015 compared to the first quarter of 2014 was reduced spending on pre-clinical and non-clinical research activities in 2015.

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.

Arno Therapeutics, Inc.
Condensed Statements of Operations
(Amounts in thousands, except per share data)
Three Months Ended
March 31,
(Unaudited)
2015 2014
Revenue $ – $ –
Operating expenses:
Research and development 2,475 4,435
General and administrative 1,388 1,729
Total operating expenses 3,863 6,164
Loss from operations (3,863) (6,164)
Interest income/(expense), net 4 12
Other income/(expense) 470 5,706
Net loss $ (3,389) $ (446)
Net loss per share – basic and diluted $ (0.17) $ (0.02)
Shares used in computation of net loss per share – basic and diluted 20,409 20,370
Balance Sheet Data
(Amounts in thousands)
March 31,
2015
(Unaudited)
December 31,
2014
Cash and cash equivalents $ 4,935 $ 7,948
Total assets $ 5,144 $ 8,248
Current liabilities $ 1,919 $ 2,157
Accumulated deficit $ (85,176) $ (81,787)
Stockholders' deficit $ (3,012) $ (589)
Reconciliation Between Reported (GAAP) and Adjusted Net Loss (Non-GAAP)
(Amounts in thousands, except per share data)
Three Months Ended
March 31,
(Unaudited)
2015 2014
Net loss, as reported (GAAP) $ (3,389) $ (446)
Adjustments for reconciled items:
Change in fair value of derivative liability, non-cash (442) (5,707)
Stock based compensation, non-cash 966 1,165
Adjusted net loss (non-GAAP) $ (2,865) $ (4,988)
Net loss per share – basic and diluted, as reported (GAAP) $ (0.17) $ (0.02)
Adjustments for reconciled items:
Change in fair value of derivative liability, non-cash (0.02) (0.28)
Stock based compensation, non-cash 0.05 0.06
Adjusted net loss per share – basic and diluted (non-GAAP) $ (0.14) $ (0.24)

CONTACT: The Ruth Group Lee Roth (investors) lroth@theruthgroup.com (646) 536-7012 Kirsten Thomas (media) kthomas@theruthgroup.com (646) 536-7014 Arno Therapeutics Lawrence Kenyon lk@arnothera.com (862) 703-7171

Source:Arno Therapeutics Inc.