FLEMINGTON, N.J ., Nov. 16, 2015 (GLOBE NEWSWIRE) -- Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company primarily focused on the development of therapeutics for cancer and other life threatening diseases, today announced financial results for the quarter ended September 30, 2015 and provided an update on recent clinical developments for its lead oncology compound, onapristone.
Third Quarter 2015 and Recent Highlights:
-
Initiated the second stage of a Phase I/II trial of onapristone in men with advanced, castration-resistant prostate cancer (CRPC);
-
Continued to actively screen and enroll patients 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 AR-12 data during podium presentation at the Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) / International Congress of Chemotherapy and Infection (ICC) 2015; and
- Entered into a Convertible Note Purchase Agreement with certain accredited investors pursuant to which the Company sold an aggregate principal amount of $2.1 million of its Unsecured Convertible Promissory Notes for an aggregate issue price of $2.1 million.
"We made continued progress in the clinical development of our lead asset, onapristone, and pre-clinical development of AR-12 during the third quarter of 2015," said Alex Zukiwski, MD, Chief Executive Officer of Arno Therapeutics. "Notably, we received approval from the UK Medicine and Healthcare products Regulatory Authority to begin enrolling patients in the second stage, which will assess safety and efficacy, of our Phase I/II trial in men with advanced castration-resistant prostate cancer. We have modified the stage 2 protocols to determine the potential benefit of single agent onapristone and onapristone in combination with abiraterone in patients who would not otherwise benefit from single agent abiraterone. We have begun screening patients for this stage of the trial and hope to treat the first stage 2 patient in the fourth quarter. In addition, data from pre-clinical studies of AR-12 were presented at various scientific congresses that support its potential as a broad-spectrum antimicrobial agent.
"Importantly, our recent issuances of $2.1 million of convertible notes 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 Third Quarter 2015
For the three months ended September 30, 2015, Arno reported net loss of $0.7 million, or $0.03 per share, which includes non-cash income of $2.2 million related to the decrease in derivative liability of common stock warrants, and $0.9 million of non-cash stock based compensation expense. Adjusting for these non-cash items, which resulted in a gain of $1.3 million, the Company reported a net loss of approximately $2.0 million, or $0.10 per share, on a non-GAAP basis. Adjusted third quarter 2014 net loss was approximately $4.6 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, third quarter 2014 net income was $0.2 million, or $0.01 per share.
Financial Results for the Nine Months Ended September 30, 2015
For the nine-months ended September 30, 2015, Arno reported net loss of $7.5 million, or $0.37 per share, which includes non-cash income of $3.2 million for the decrease in derivative liability of common stock warrants, and $2.9 million of non-cash stock based compensation expense. Adjusting for these non-cash items, which resulted in a gain of $0.3 million, net loss for the period was approximately $7.8 million, or $0.38 per share, on a non-GAAP basis. This compares to an adjusted non-GAAP net loss for the first nine months of 2014 of approximately $14.1 million, or $0.69 per share, when considering the same non-cash adjustments as the first nine months of 2015. On a GAAP basis, 2014 net income through the first nine months was $3.2 million, or $0.16 per share.
The primary factor for the $2.6 million year-over-year improvement in adjusted (non-GAAP) net loss in the third quarter of 2015 compared to the second quarter of 2014, as well as the $6.2 million year-over-year improvement in adjusted (non-GAAP) net loss in the first nine months of 2015 compared to the first nine months 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, and lower severance payments of $0.4 million related to the departure of the Company's previous CEO in 2014.
Cash and cash equivalents as of September 30, 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 October 2015, the current level of cash resources is expected to fund the Company through the fourth 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, the potential benefits of the Company's clinical trial evaluating single agent onapristone and onapristone in combination with abiraterone in patients who would not otherwise benefit from single agent abiraterone, the Company's expectation that its current cash resources are sufficient to fund its operations through December 2015, 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 Arno requires additional capital to fund its operations beyond December 2015, 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 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 September 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 | Nine Months Ended | |||
| September 30, | September 30, | |||
| (Unaudited) | (Unaudited) | |||
| 2015 | 2014 | 2015 | 2014 | |
| Revenue | $ – | $ – | $ – | $ – |
| Operating expenses: | ||||
| Research and development | 1,793 | 3,756 | 6,915 | 12,275 |
| General and administrative | 1,082 | 1,919 | 3,801 | 5,328 |
| Total operating expenses | 2,875 | 5,675 | 10,716 | 17,603 |
| Loss from operations | (2,875) | (5,675) | (10,716) | (17,603) |
| Interest income/(expense), net | -- | 10 | 6 | 35 |
| Other income/(expense), net | 2,196 | 5,824 | 3,197 | 20,776 |
| Net income/(loss) | $(679) | $159 | $(7,513) | $3,208 |
| Net income/(loss) per share – basic | $(0.03) | $0.01 | $(0.37) | $0.16 |
| Shares used in computation of net loss per share – basic | 20,409 | 20,377 | 20,409 | 20,372 |
| Net income/(loss) per share – diluted | $(0.03) | $0.01 | $(0.37) | $0.13 |
| Shares used in computation of net loss per share – diluted | 20,409 | 24,802 | 20,409 | 24,805 |
| Balance Sheet Data | ||
| (Amounts in thousands) | ||
| September 30, 2015 | December 31, | |
| (Unaudited) | 2014 | |
| Cash and cash equivalents | $123 | $7,948 |
| Total assets | $410 | $8,248 |
| Current liabilities | $2,164 | $2,157 |
| Accumulated deficit | $(89,300) | $(81,787) |
| Stockholders' deficit | $(5,245) | $(589) |
| Reconciliation Between Reported (GAAP) and Adjusted Net Income/(Loss) (Non-GAAP) | ||
| (Amounts in thousands, except per share data) | ||
| Three Months Ended | ||
| September 30, | ||
| 2015 | 2014 | |
| Net income/(loss), as reported (GAAP) | $(679) | $159 |
| Adjustments for reconciled items: | ||
| Change in fair value of derivative liability, non-cash | (2,199) | (5,795) |
| Stock based compensation, non-cash | 934 | 1,084 |
| Adjusted net income/(loss) (non-GAAP) | $(1,944) | $(4,552) |
| Net income/(loss) per share - basic, as reported (GAAP) | $(0.03) | $0.01 |
| Adjustments for reconciled items: | ||
| Change in fair value of derivative liability, non-cash | (0.11) | (0.28) |
| Stock based compensation, non-cash | 0.04 | 0.05 |
| Adjusted net income/(loss) per share - basic (non-GAAP) | $(0.10) | $(0.22) |
| Nine Months Ended | ||
| September 30, | ||
| 2015 | 2014 | |
| Net income/(loss), as reported (GAAP) | $(7,513) | $3,208 |
| Adjustments for reconciled items: | ||
| Change in fair value of derivative liability, non-cash | (3,186) | (20,778) |
| Stock based compensation, non-cash | 2,857 | 3,502 |
| Adjusted net income/(loss) (non-GAAP) | $(7,842) | $(14,068) |
| Net income/(loss) per share - basic, as reported (GAAP) | $(0.37) | $0.16 |
| Adjustments for reconciled items: | ||
| Change in fair value of derivative liability, non-cash | (0.15) | (1.02) |
| Stock based compensation, non-cash | 0.14 | 0.17 |
| Adjusted net income/(loss) per share - basic (non-GAAP) | $(0.38) | $(0.69) |