FLEMINGTON, N.J.--(BUSINESS WIRE)--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.
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.