FLEMINGTON, N.J., March 30, 2016 (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 fourth quarter and full year of 2015 and provided an update on recent clinical developments for its lead compound, onapristone.
Fourth Quarter 2015 and Recent Highlights
- In January 2016, Arno completed an equity financing of approximately $7.4 million, including approximately $2.1 million from the automatic conversion of outstanding promissory notes originally issued in October 2015.
- Arno 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.
- Arno initiated clinical sites in the United States for its Phase II trial of onapristone in women with recurrent or metastatic endometrioid tumors that have been shown to express the progesterone receptor (PR), and who have received no more than one prior chemotherapy and no prior hormone therapy. Arno also continued enrolling patients in European sites of the Phase II trial of onapristone in women with recurrent or metastatic endometrioid tumors.
- In a poster presentation at the 15th European AIDS Conference in October, Arno presented AR-12 data demonstrating that AR-12 has potent antiviral activity against drug-resistant HIV strains.
- Arno also presented AR-12 data in a poster presentation at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition in October demonstrating AR-12 as a novel antifungal drug against common finger and toenail fungus, Onychomycosis.
“We continue to advance our onapristone clinical development program with the first patient recently entered into the second stage of the Phase II castration-resistant prostate cancer study in combination with abiraterone and the US site actively screening patients for the Phase II endometrioid cancer program,” said Alex Zukiwski, MD, Chief Executive Officer of Arno Therapeutics. “Importantly, the recently completed capital raise has strengthened our cash position and provided us the capital needed to continue advancing the development of onapristone. We are grateful to the shareholders who participated in the financing for their continued support.”
Financial Results for the Fourth Quarter 2015
For the three months ended December 31, 2015, Arno reported net loss of $4.0 million, or $0.20 per share, which includes a non-cash expense of $1.3 million related to the increase in derivative liability of common stock warrants, and $0.6 million of non-cash stock based compensation expense. Adjusting for these non-cash items, which resulted in a loss of $1.9 million, the Company reported a net loss of approximately $2.1 million, or $0.10 per share, on a non-GAAP basis. Adjusted fourth quarter 2014 net loss was approximately $2.8 million, or $0.14 per share, on a non-GAAP basis, which includes the same non-cash adjustments as the fourth quarter of 2015. On a GAAP basis, fourth quarter 2014 net income was $4.6 million, or $0.22 per share.
The primary factor for the $0.7 million year-over-year improvement in adjusted (non-GAAP) net loss in the fourth quarter of 2015 compared to the fourth quarter of 2014, was reduced spending on pre-clinical and non-clinical research activities that supported the initiation of the Phase I/II clinical trials and companion diagnostic development program on Arno’s lead compound, onapristone.
Financial Results for the Twelve Months Ended December 31, 2015
For the year ended December 31, 2015, Arno reported net loss of $11.5 million, or $0.56 per share, which includes non-cash income of $1.9 million for the decrease in derivative liability of common stock warrants, and $3.4 million of non-cash stock based compensation expense. Adjusting for these non-cash items, which resulted in a benefit of $1.5 million, net loss for the period was approximately $10.0 million, or $0.49 per share, on a non-GAAP basis. This compares to an adjusted non-GAAP net loss for the twelve months of 2014 of $16.9 million, or $0.83 per share, when considering the same non-cash adjustments as for the twelve months of 2015. On a GAAP basis, full-year 2014 net income was $7.8 million, or $0.38 per share.
The primary factor for the $6.9 million year-over-year improvement in adjusted (non-GAAP) net loss in the twelve months of 2015 compared to the twelve months of 2014, was reduced spending of $5.5 million on pre-clinical and non-clinical research activities that supported the initiation of the Phase I/II clinical trials and companion diagnostic development program in 2014 on Arno’s lead compound, onapristone. The company incurred lower compensation costs and professional fees of $0.8 million and $0.4 million, respectively, in 2015 over the same period of 2014.
Cash and cash equivalents as of December 31, 2015 totaled $0.1 million, compared to $7.9 million as of December 31, 2014. In combination with the capital raised by the Company in January 2016, the current level of cash resources is expected to fund the Company’s planned operating activities through May 2016.
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 US 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, that we will not obtain the capital necessary to fund our operations in a timely manner, if ever, or on acceptable terms, 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. 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 December 31, (Unaudited) | Full Year Ended December 31, | ||||||||||||||||||
| 2015 | 2014 | 2015 | 2014 | ||||||||||||||||
| Revenue | $ | – | $ | – | $ | – | $ | – | |||||||||||
| Operating expenses: | |||||||||||||||||||
| Research and development | 1,738 | 2,566 | 8,653 | 14,840 | |||||||||||||||
| General and administrative | 958 | 1,325 | 4,759 | 6,653 | |||||||||||||||
| Total operating expenses | 2,696 | 3,891 | 13,412 | 21,493 | |||||||||||||||
| Loss from operations | (2,696 | ) | (3,891 | ) | (13,412 | ) | (21,493 | ) | |||||||||||
| Interest income/(expense), net | (27 | ) | 7 | (21 | ) | 42 | |||||||||||||
| Other income/(expense) | (1,272 | ) | 8,447 | 1,925 | 29,222 | ||||||||||||||
| Net income/(loss) | $ | (3,995 | ) | $ | 4,563 | $ | (11,508 | ) | $ | 7,771 | |||||||||
| Net income/(loss) per share – basic | $ | (0.20 | ) | $ | 0.22 | $ | (0.56 | ) | $ | 0.38 | |||||||||
| Shares used in computation of net loss per share – basic | 20,409 | 20,409 | 20,409 | 20,382 | |||||||||||||||
| Net income/(loss) per share – diluted | $ | (0.20 | ) | $ | 0.18 | $ | (0.56 | ) | $ | 0.31 | |||||||||
| Shares used in computation of net loss per share – diluted | 20,409 | 24,814 | 20,409 | 24,810 | |||||||||||||||
| Balance Sheet Data | |||||||
| (Amounts in thousands) | |||||||
| December 31, 2015 | December 31, 2014 | ||||||
| Cash and cash equivalents | $ | 67 | $ | 7,948 | |||
| Total assets | $ | 361 | $ | 8,248 | |||
| Current liabilities | $ | 4,231 | $ | 2,157 | |||
| Accumulated deficit | $ | (93,295 | ) | $ | (81,787 | ) | |
| Stockholders’ deficit | $ | (8,624 | ) | $ | (589 | ) | |
| Reconciliation Between Reported (GAAP) and Adjusted Net Income/(Loss) (Non-GAAP) | |||||||
| (Amounts in thousands, except per share data) | |||||||
| Three Months Ended | |||||||
| December 31, | |||||||
| 2015 | 2014 | ||||||
| Net income/(loss), as reported (GAAP) | $ | (3,995 | ) | $ | 4,563 | ||
| Adjustments for reconciled items: | |||||||
| Interest expense, non-cash | 2 | - | |||||
| Change in fair value of derivative liability, non-cash | 1,265 | (8,415 | ) | ||||
| Stock based compensation, non-cash | 615 | 1,022 | |||||
| Adjusted net loss (non-GAAP) | $ | (2,113 | ) | $ | (2,830 | ) | |
| Net income/(loss) per share - basic, as reported (GAAP) | $ | (0.20 | ) | $ | 0.22 | ||
| Adjustments for reconciled items: | |||||||
| Interest expense, non-cash | - | - | |||||
| Change in fair value of derivative liability, non-cash | 0.07 | (0.41 | ) | ||||
| Stock based compensation, non-cash | 0.03 | 0.05 | |||||
| Adjusted net loss per share - basic (non-GAAP) | $ | (0.10 | ) | $ | (0.14 | ) | |
| Year Ended | |||||||
| December 31, | |||||||
| 2015 | 2014 | ||||||
| Net income/(loss), as reported (GAAP) | $ | (11,508 | ) | $ | 7,771 | ||
| Adjustments for reconciled items: | |||||||
| Interest expense, non-cash | 2 | - | |||||
| Change in fair value of derivative liability, non-cash | (1,921 | ) | (29,193 | ) | |||
| Stock based compensation, non-cash | 3,473 | 4,524 | |||||
| Adjusted net loss (non-GAAP) | $ | (9,954 | ) | $ | (16,898 | ) | |
| Net income/(loss) per share - basic, as reported (GAAP) | $ | (0.56 | ) | $ | 0.38 | ||
| Adjustments for reconciled items: | |||||||
| Interest expense, non-cash | - | - | |||||
| Change in fair value of derivative liability, non-cash | (0.10 | ) | (1.43 | ) | |||
| Stock based compensation, non-cash | 0.17 | 0.22 | |||||
| Adjusted net loss per share - basic (non-GAAP) | $ | (0.49 | ) | $ | (0.83 | ) | |