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Arno Therapeutics Reports Second Quarter 2016 Financial and Business Update
[August 22, 2016]

Arno Therapeutics Reports Second Quarter 2016 Financial and Business Update


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 June 30, 2016 and provided an update on recent clinical developments for its lead compound, onapristone.

Q2 2016 and Recent Highlights:

  • On August 15, 2016, Arno completed a private placement of its common stock and common stock purchase warrants that will result in gross proceeds to the Company of approximately $2.8 million.
  • Arno continued to 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 is actively recruiting and is designed to evaluate onapristone in combination with Zytiga® (abiraterone acetate) in patients with CRPC.

"We are making good progress with the enrollment into CRPC study. The data review committee has agreed to enrollment at the higher onapristone dose levels of the Phase II cohort and the US investigative sites are being opened to enrollment," said Alex Zukiwski, MD, Chief Executive Officer of Arno Therapeutics. "More importantly, the recently completed capital raise will allow us to continue the clinical development of our lead product, onapristone, including enrollment in our ongoing phase 2 clinical trial in castrate resistant prostate cancer (CRPC). The Board of Directors and the management team are very grateful for the continued support shown by several of our existing investors who participated in this financing."

Second Quarter 2016 Financial Results

For the three months ended June 30, 2016, Arno reported net loss of $2.1 million, or $0.05 per share, which includes non-cash income of $1.1 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 an income of $0.1 million, the Company reported a net loss of approximately $2.2 million, or $0.05 per share, on a non-GAAP basis. Adjusted second quarter 2015 net loss was approximately $3.0 million, or $0.15 per share, on a non-GAAP basis, which includes the same non-cash adjustments as second quarter 2016. On a GAAP basis, second quarter 2015 net loss was $3.4 million, or $0.17 per share.

The primary factors for the $0.8 million year-over-year improvement in adjusted (non-GAAP) net loss in the second quarter of 2016 compared to the second quarter of 2015 were reduced spending of $0.2 million on onapristone's pre-clinical and non-clinical research activities mostly offset by costs associated with terminating onapristone's Phase I/II clinical trial evaluating onapristone in women with progesterone receptor (PR) expressing tumors and lower compensation expense of $0.5 million.

For the six months ended June 30, 2016, Arno reported net loss of $5.9 million, or $0.15 per share, which includes non-cash income of $0.2 million related to the decrease in derivative liability of common stock warrants, and $1.9 million of non-cash stock based compensation expense. Adjusting for these non-cash items, which resulted in an expense of $1.7 million, the Company reported a net loss of approximately $4.2 million, or $0.10 per share, on a non-GAAP basis. This compares to an adjusted non-GAAP net loss for the first half of 2015 of approximately $5.9 million, or $0.29 per share, when considering the same non-cash adjustments as for the first half 2016. On a GAAP basis, first half 2015 net loss was $6.8 million, or $0.33 per share.

The primary factors for the $1.7 million year-over-year improvement in adjusted (non-GAAP) net loss in the first half of 2016 compared to the first half of 2016 were reduced spending of $0.8 million on onapristone's pre-clinical and non-clinical research activities mostly offset by costs associated with terminating onapristone's Phase I/II clinical trial evaluating onapristone in women with progesterone receptor (PR) expressing tumors and lower compensation expense of $0.7 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 June 30, 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.



           

Arno Therapeutics, Inc.

Condensed Statements of Operations

 (Amounts in thousands, except per share data)

 
Three Months Ended

June 30,

(Unaudited)

Six Months Ended

June 30,

(Unaudited)

  2016         2015     2016         2015  
Revenue

$

-

$ - $ - $ -
Operating expenses:
Research and development 2,056 2,648 3,600 5,123
General and administrative   1,254     1,331     2,535     2,719  
Total operating expenses   3,310     3,979     6,135     7,842  
Loss from operations (3,310 ) (3,979 ) (6,135 ) (7,842 )
Interest income/(expense), net 1 2 (12 ) 6
Other income/(expense), net   1,167     532       296     1,002  
Net income/(loss) $ (2,142 ) $ (3,445 ) $ (5,851 ) $ (6,834 )
Net income/(loss) per share - basic and diluted $ (0.05 ) $ (0.17 ) $ (0.15 ) $ (0.33 )
Shares used in computation of net loss per share - basic and diluted   41,563     20,409     40,168     20,409  
 

             

Balance Sheet Data

(Amounts in thousands)

 
June 30,

2016

(Unaudited)

December 31,

2015

Cash and cash equivalents $ 937 $ 67
Total assets $ 1,099 $ 361
Current liabilities $ 1,784 $ 4,231
Accumulated deficit $ (99,146 ) $ (93,295 )
Stockholders' deficit $ (5,219 ) $ (8,624 )
 
         

Reconciliation Between Reported (GAAP) and Adjusted Net Loss (Non-GAAP)

(Amounts in thousands, except per share data)

 
Three Months Ended

June 30,

2016     2015
Net income/(loss), as reported (GAAP) $ (2,142 ) $ (3,445 )
Adjustments for reconciled items:
Change in fair value of derivative liability, non-cash (1,118 ) (545 )
Stock based compensation, non-cash   1,013     957  
Adjusted net income/(loss) (non-GAAP) $ (2,247 ) $ (3,033 )
 
Net income/(loss) per share - basic, as reported (GAAP) $ (0.05 ) $ (0.17 )
Adjustments for reconciled items:
Change in fair value of derivative liability, non-cash (0.03 ) (0.03 )
Stock based compensation, non-cash   0.03     0.05  
Adjusted net income/(loss) per share - basic (non-GAAP) $ (0.05 ) $ (0.15 )
 
        Six Months Ended

June 30,

2016     2015
Net income/(loss), as reported (GAAP) $ (5,851 ) $ (6,843 )
Adjustments for reconciled items:
Change in fair value of derivative liability, non-cash (220 ) (987 )
Stock based compensation, non-cash   1,921     1,923  
Adjusted net income/(loss) (non-GAAP) $ (4,150 ) $ (5,907 )
 
Net income/(loss) per share - basic, as reported (GAAP) $ (0.15 ) $ (0.33 )
Adjustments for reconciled items:
Change in fair value of derivative liability, non-cash - (0.05 )
Stock based compensation, non-cash   0.05     0.09  
Adjusted net income/(loss) per share - basic (non-GAAP) $ (0.10 ) $ (0.29 )
 


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