ARNI Arno Therapeutics Inc (CE)

Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, today announced financial results for the full year ended December 31, 2013. For the year ended December 31, 2013, Arno reported a net loss of $39.7 million, or $5.28 per share, which includes $19.0 million related to non-cash interest expense from convertible debentures retired in 2013, $4.2 million of non-cash other expense for the increase in derivative liability of stock warrants, and $1.5 million of non-cash stock based compensation expense. Adjusting for these non-cash items, which totaled $24.7 million, the Company realized a net loss of $15.0 million on a non-GAAP basis, or $2.00 per share. This compares to full year 2012 net loss of $14.4 million, or $3.17 per share on a GAAP basis, and adjusted 2012 net loss of $10.2 million on a non-GAAP basis, or $2.25 per share, when considering the same non-cash adjustments.

The primary factor for the $4.8 million year-over-year increase in adjusted net loss was increased R&D expenses, primarily associated with preparing for the initiation of two Phase I clinical trials of Arno's lead compound, onapristone, which occurred in the first quarter of 2014.

2013 Highlights

Key Arno accomplishments in 2013 included:

• The initiation and completion of a pharmacokinetic (PK) study of onapristone;   
• Receipt of approval of an Investigational Medicinal Product Dossier (IMPD) from the French Health Authority to begin a multi-center Phase I dose escalation clinical trial evaluating onapristone in post-menopausal women with progesterone receptor (PR) positive tumors, including breast, endometrial and others solid tumors;  
• Completion of a private placement of newly issued shares of common stock and common stock warrants resulting in gross proceeds to Arno of $30.7 million and retirement of the company's convertible debt; and  
• Announcements of important onapristone data at multiple scientific meetings, including:    -- A poster presentation at the American Association of Cancer Research (AACR) Annual Meeting 2013 showing evidence that activated progesterone receptors are predictive of a response to onapristone in pre-clinical breast cancer models;    -- Three poster presentations at the American Society for Clinical Oncology (ASCO) 2013 Annual Meeting providing pre-clinical data suggesting that the presence of activated progesterone receptors in cells predict anti-progestin efficacy in endometrial and breast cancers;    -- Two posters presented at the European Cancer Congress (ECC) 2013 Annual Meeting providing pre-clinical support for development of a companion diagnostic to identify patients more likely to benefit from onapristone therapy;   -- A poster presentation at the 20th annual Prostate Cancer Foundation Annual Retreat discussing pre-clinical data supporting further evaluation of onapristone in castrate-resistant prostate cancer with the presence of activated progesterone receptor; and    -- Two poster presentations at the 2013 San Antonio Breast Cancer Symposium analyzing pre-clinical breast cancer data supporting the development of a diagnostic test to identify patient tumors with activated progesterone receptor and activated estrogen receptor as potential biomarkers for anti-progestin and anti-estrogen activity.

"2013 was a pivotal year at Arno, and our accomplishments during the past year give us confidence that 2014 will achieve further clinical advancement and milestones for our lead compound, onapristone," said Glenn Mattes, President and CEO of Arno Therapeutics. "We were able to move onapristone forward very efficiently, culminating in the approval of our Phase I clinical trial design in France to evaluate onapristone in post-menopausal women with PR positive tumors, including breast, endometrial and others solid tumors, which has already begun enrolling patients in the first quarter of 2014. Additionally, we were able to complete a capital restructuring that resulted in the retirement of our convertible debentures and provided over $30 million in gross proceeds to Arno for the continued development of onapristone in the clinic."

Mr. Mattes added, "Importantly, our accomplishments of the past year have created clear momentum in the early part of 2014. We began the year with the announcement of an important new partnership for the development of an onapristone companion diagnostic, followed by the enrollment of the first patient in our Phase I trial of onapristone in patients with progesterone receptor positive solid tumors and the initiation of the Phase I trial of onapristone in men with advanced castration-resistant prostate cancer. In addition, we significantly strengthened our leadership suite with strategic executive and Board-level appointments throughout the first quarter. Overall, we believe we are well positioned to continue executing on our clinical development strategy and 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, 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.

Arno Therapeutics, Inc.
Condensed Statements of Operations
(Amounts in thousands, except per share data)
	Year Ended December 31,
	2013	2012
Revenue	$ –	$ –
Operating expenses
Research and development	13,476	8,537
General and administrative	3,464	2,299
Total operating expenses	16,941	10,836
Loss from operations	(16,941)	(10,836)
Interest expense, net	(18,551)	(6,353)
Other (expense) income	(4,165)	2,801
Net loss	$ (39,657)	$ (14,388)
Net loss per share – basic and diluted	$ 5.28	$ 3.17
Shares used in computation of net loss per share – basic and diluted	7,516	4,540

Balance Sheet Data
(Amounts in thousands)
	December 31,
	2013	2012
Cash and cash equivalents	$ 26,774	$ 10,943
Total assets	$ 26,883	$ 11,147
Current liabilities	$ 3,901	$ 3,246
Accumulated deficit	$ (89,558)	$ (49,901)
Stockholders' deficit	$ (12,883)	$ (12,265)

Reconciliation Between Reported (GAAP) and Adjusted Net Loss (Non-GAAP)
(Amounts in thousands, except per share data)
	Year Ended December 31,
	2013	2012
Net loss, as reported (GAAP)	$ (39,657)	$ (14,388)
Adjustments for reconciled items:
Interest expense, non-cash	18,997	6,256
Change in fair value of derivative liability, non-cash	4,166	(2,807)
Stock based compensation, non-cash	1,457	723
Adjusted net loss (non-GAAP)	$ (15,037)	$ (10,216)

CONTACT: The Ruth Group
         Lee Roth (investors)
         lroth@theruthgroup.com
         (646) 536-7012
         
         Kirsten Thomas (media)
         kthomas@theruthgroup.com
         (646) 536-7014
         
         Arno Therapeutics
         Glenn Mattes
         gm@arnothera.com
         (862) 703-7176