FLEMINGTON, N.J., Aug. 14, 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 June 30, 2015 and provided an update on recent clinical developments for its lead oncology compound, onapristone.
Second Quarter 2015 and Recent Highlights:
- Completed enrollment of patients in the first stage of a Phase I/II trial of onapristone in men with advanced, castration-resistant prostate cancer (CRPC) who have failed treatment with abiraterone or enzalutamide;
- 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;
- Presented data supporting the onapristone development program – including efficacy and safety results from a Phase I study in women with progesterone receptor (PR)-expressing tumors – 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;
- Strengthened intellectual property portfolio with United States Patent Number 9,046,534, issued by the U.S. Patent and Trademark Office (USPTO), related to the methods and systems for identifying and treating patients with anti-progestin sensitive tumors using onapristone;
- Presented data at the 28th Annual International Conference on Antiviral Research (ICAR) demonstrating broad spectrum antiviral activity for AR-12;
- Received orphan medicinal product designation in Europe for AR-12 for the treatment of cryptococcosis and tularaemia; and
- Entered into a Cooperative Research and Development Agreement (CRADA) Material Transfer Agreement with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) to evaluate the anti-viral activity of AR-12 and various analogues against Ebola and other pathogens of biodefense interest.
“We continued to make progress in the onapristone clinical development program, as well as with AR-12 in the pre-clinical setting, during the second quarter of 2015,” said Alex Zukiwski, MD, Chief Executive Officer of Arno Therapeutics. “The first stage in our Phase I/II study evaluating the dose-escalation of onapristone in men with CRPC has been completed and we expect to begin enrollment in the next stage, which will assess safety and efficacy, during the third quarter. Additionally, recent research developments with AR-12 have begun to provide us with data that further support AR-12 as a broad spectrum antimicrobial agent.”
Financial Results for the Second Quarter 2015
For the three months ended June 30, 2015, Arno reported net loss of $3.4 million, or $0.17 per share, which includes non-cash income of $0.5 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 $3.0 million, or $0.15 per share, on a non-GAAP basis. Adjusted second quarter 2014 net loss was approximately $4.5 million, or $0.22 per share, on a non-GAAP basis, which includes the same non-cash adjustments as second quarter 2015. On a GAAP basis, second quarter 2014 net income was $3.5 million, or $0.17 per share.
Financial Results for the Six Months Ended June 30, 2015
For the six-months ended June 30, 2015, Arno reported net loss of $6.8 million, or $0.33 per share, which includes non-cash income of $1.0 million for 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 a gain of $0.9 million, net loss for the period was approximately $5.9 million, or $0.29 per share, on a non-GAAP basis. This compares to an adjusted non-GAAP net loss for the first-half of 2014 of approximately $9.5 million, or $0.47 per share, when considering the same non-cash adjustments as first half 2015. On a GAAP basis, first half 2014 net income was $3.0 million, or $0.15 per share.
The primary factor for the $1.5 million year-over-year improvement in adjusted (non-GAAP) net loss in the second quarter of 2015 compared to the second quarter of 2014, as well as the $3.6 million year-over-year improvement in adjusted (non-GAAP) net loss in the first half of 2015 compared to the first half of 2014, was reduced spending on non-clinical research and CMC activities in 2015 due to the advancement of onapristone into human clinical trials beginning in 2014.
Cash and cash equivalents as of June 30, 2015 totaled $2.4 million, compared to $7.9 million as of December 31, 2014. The current level of cash resources is expected to fund the Company through the third quarter of 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 product candidates. These compounds are in clinical or preclinical development as product candidates to treat solid tumors and hematologic malignancies, as well as infectious diseases. 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 Company’s financial condition and cash resources, 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 made. Various important factors could cause actual results or events to differ materially from the forward-looking statements that are made. Such factors include, among others, risks that negative cash flows and the need for additional capital may threaten Arno’s ability to continue as a going concern, the results of clinical trials will not support the Company’s claims or beliefs concerning the effectiveness of onapristone or any of its other product candidates, the ability to successfully develop a diagnostic to identify APR tumors, the ability to finance the development of Arno’s product candidates, regulatory risks, and the 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, and its Quarterly Report on Form 10-Q for the period ended June 30, 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 | Six Months Ended | |||
| June 30, | June 30, | |||
| (Unaudited) | (Unaudited) | |||
| 2015 | 2014 | 2015 | 2014 | |
| Revenue | $ – | $ – | $ – | $ – |
| Operating expenses: | ||||
| Research and development | 2,648 | 4,083 | 5,123 | 8,518 |
| General and administrative | 1,331 | 1,680 | 2,719 | 3,409 |
| Total operating expenses | 3,979 | 5,763 | 7,842 | 11,927 |
| Loss from operations | (3,979) | (5,763) | (7,842) | (11,927) |
| Interest income/(expense), net | 2 | 13 | 6 | 25 |
| Other income/(expense), net | 532 | 9,245 | 1,002 | 14,950 |
| Net income/(loss) | $ (3,445) | $ 3,495 | $ (6,834) | $ 3,048 |
| Net income/(loss) per share – basic | $ (0.17) | $ 0.17 | $ (0.33) | $ 0.15 |
| Shares used in computation of net loss per share – basic | 20,409 | 20,370 | 20,409 | 20,370 |
| Net income/(loss) per share – diluted | $ (0.17) | $ 0.14 | $ (0.33) | $ 0.12 |
| Shares used in computation of net loss per share – diluted | 20,409 | 20,803 | 20,409 | 20,805 |
| Balance Sheet Data | |||
| (Amounts in thousands) | |||
| June 30, 2015 (Unaudited) | December 31, 2014 | ||
| Cash and cash equivalents | $ 2,368 | $ 7,948 | |
| Total assets | $ 2,576 | $ 8,248 | |
| Current liabilities | $ 2,385 | $ 2,157 | |
| Accumulated deficit | $ (88,621) | $ (81,787) | |
| Stockholders’ deficit | $ (5,500) | $ (589) | |
| Reconciliation Between Reported (GAAP) and Adjusted Net Income/(Loss) (Non-GAAP) | ||
| (Amounts in thousands, except per share data) | ||
| Three Months Ended | ||
| June 30, | ||
| 2015 | 2014 | |
| Net income/(loss), as reported (GAAP) | $ (3,445) | $ 3,495 |
| Adjustments for reconciled items: | ||
| Change in fair value of derivative liability, non-cash | (545) | (9,276) |
| Stock based compensation, non-cash | 957 | 1,253 |
| Adjusted net income/(loss) (non-GAAP) | $ (3,033) | $ (4,528) |
| Net income/(loss) per share - basic, as reported (GAAP) | $ (0.17) | $ 0.17 |
| Adjustments for reconciled items: | ||
| Change in fair value of derivative liability, non-cash | (0.03) | (0.45) |
| Stock based compensation, non-cash | 0.05 | 0.06 |
| Adjusted net income/(loss) per share - basic (non-GAAP) | $ (0.15) | $ (0.22) |
| Six Months Ended | ||
| June 30, | ||
| 2015 | 2014 | |
| Net income/(loss), as reported (GAAP) | $ (6,834) | $ 3,048 |
| Adjustments for reconciled items: | ||
| Change in fair value of derivative liability, non-cash | (987) | (14,983) |
| Stock based compensation, non-cash | 1,923 | 2,418 |
| Adjusted net income/(loss) (non-GAAP) | $ (5,898) | $ (9,517) |
| Net income/(loss) per share - basic, as reported (GAAP) | $ (0.33) | $ 0.15 |
| Adjustments for reconciled items: | ||
| Change in fair value of derivative liability, non-cash | (0.05) | (0.74) |
| Stock based compensation, non-cash | 0.09 | 0.12 |
| Adjusted net income/(loss) per share - basic (non-GAAP) | $ (0.29) | $ (0.47) |
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
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