SANTA MONICA, Calif., June 15, 2017 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. (“Opiant”) (OTCQB:OPNT), a specialty pharmaceutical company developing pharmacological treatments for addictions and eating disorders, today reported financial results for the fiscal third quarter ended April 30, 2017 and provided an update on recent developments and upcoming milestones.
“In the fiscal third quarter, we have made notable progress on our clinical and corporate goals for 2017. On the clinical side, we initiated a Phase 2 clinical trial evaluating our novel, nasally-delivered opioid antagonist candidate, OPNT001, as a potential treatment for Bulimia Nervosa (BN). Additionally, our Alcohol Use Disorder (AUD) program and our pre-clinical work on a heroin vaccine candidate continue to advance. We also gained insight into the effect of two different dosages of nasal naloxone on opioid receptors using positron emission tomography (PET) imaging,” said Roger Crystal, M.D., Chief Executive Officer of Opiant. “On the corporate front, we continue to support our NARCAN® Nasal Spray partner, Adapt Pharma Limited, and continue to improve our intellectual property position. In the last nine months, we have also added depth to our management team and have strengthened our corporate governance by appointing a new director to our Board of Directors and by forming committees of our Board of Directors. We remain committed to creating value for our stockholders by working to fulfill our clinical and corporate goals.”
Fiscal Third Quarter 2017 Highlights
- Initiated a Phase 2 randomized, double-blind, placebo-controlled multisite study that will enroll up to 80 patients in the United Kingdom diagnosed with BN. The trial is evaluating OPNT001, Opiant’s novel nasally-delivered opioid antagonist candidate. The study is designed to evaluate OPNT001’s safety and tolerability, as well as its impact on clinical outcomes, including changes in eating behavior. Opiant expects to report topline data from this study in the first half of 2018.
- Generated encouraging Phase 1 data and received supportive U.S. Food and Drug Administration (FDA) feedback on a proposed clinical development plan for OPNT002 for treatment of AUD.
- Announced the completion of a study conducted in Finland, evaluating two doses of naloxone nasal spray on the occupation of brain opiate receptors using PET imaging. The purpose of the study was to determine the extent and time course of brain mu opioid receptor occupancy following the administration of two doses (four milligrams and two milligrams) in healthy volunteers. This study was the first use of PET imaging to assess nasal naloxone on opioid receptor dynamics. The 4 mg dose resulted in a larger degree of receptor occupancy in the brain than the 2 mg dose, and receptor occupancy was also achieved more rapidly with the 4 mg dose. Nasal naloxone was safe and well tolerated at both dose levels. The study results are expected to be independently published in a scientific journal.
- Strengthened our intellectual property position and enhanced NARCAN® Nasal Spray product exclusivity with the addition of two patents listed in the FDA’s Approved Drug Products with Therapeutic Equivalents Evaluations publication (commonly referred to as the “Orange Book”). There are now four Orange Book-listed patents covering NARCAN® Nasal Spray.
- Expanded the leadership team through the appointment of Phil Skolnick, Ph.D., D.Sc. (hon) as Chief Scientific Officer.
Upcoming Corporate and Clinical Goals
- Further advance OPNT002 for AUD in the second half of 2017.
- Further advance the pre-clinical development of Opiant’s heroin vaccine candidate, which was licensed in October 2016 from the Walter Reed Army Institute of Research and the National Institute on Drug Abuse (NIDA).
- Complete an uplisting to a major stock exchange.
- Reincorporate from a Nevada corporation to a Delaware corporation.
Financial Results
Quarter ended April 30, 2017 compared to quarter ended April 30, 2016
For the quarter ended April 30, 2017, Opiant reported a net loss of approximately $3.1 million, or a net loss of $1.55 per basic share and fully-diluted share, compared to a net profit of approximately $0.4 million, or $0.22 per basic share and $0.15 per fully-diluted share, for the same period in 2016.
For the quarter ended April 30, 2017, Opiant generated revenue of $18,116, compared to approximately $2.6 million in the corresponding period in 2016. As a result of Opiant’s December 2016 royalty monetization agreement with SWK Holdings Corporation (“SWK”) which generated $13.7 million at closing, SWK acquired rights to certain royalties and milestone payments related to the net sales of NARCAN® Nasal Spray. Pursuant to the royalty monetization agreement, after SWK has received 1.5 times its investment, Opiant will receive at least 90% of future NARCAN® Nasal Spray royalties and milestone payments.
Research and development expenses were approximately $1.1 million for each of the quarters ended April 30, 2017 and 2016. General and administrative expenses were approximately $2.0 million in the quarter ended April 30, 2017, compared to approximately $1.0 million for the same period in 2016. Selling expenses were approximately $0.1 million for each of the quarters ended April 30, 2017 and 2016.
Nine months ended April 30, 2017 compared to nine months ended April 30, 2016
For the nine months ended April 30, 2017, Opiant reported a net profit of approximately $6.9 million, or $3.45 per basic share and $3.07 per fully-diluted share, compared to a net loss of approximately $6.7 million, or $3.57 per basic and fully-diluted share, for the same period in 2016.
For the nine months ended April 30, 2017, Opiant generated revenue of approximately $14.7 million, compared to approximately $9.6 million in the corresponding period in 2016.
Research and development expenses were approximately $1.9 million for the nine months ended April 30, 2017 compared to approximately $2.8 million for the same period in 2016. General and administrative expenses were approximately $4.6 million for the nine months ended April 30, 2017, compared to approximately $13.2 million for the same period in 2016. Selling expenses were approximately $1.3 million for the nine months ended April 30, 2017, compared to approximately $0.3 million for the corresponding period in 2016.
Opiant ended the fiscal third quarter 2017 with cash and cash equivalents of approximately $9.7 million.
About Opiant Pharmaceuticals, Inc.
Opiant Pharmaceuticals, Inc., is a specialty pharmaceutical company developing pharmacological treatments for addictions and eating disorders. NIDA, a division of the National Institutes of Health (NIH), describes these disorders as chronic relapsing brain diseases which burden society at both the individual and community levels. With its innovative opioid antagonist nasal delivery technology, Opiant is positioned to become a leader in these treatment markets. Its first product, NARCAN® Nasal Spray, is approved for marketing in the U.S. and Canada by the company’s partner, Adapt Pharma Limited. For more information please visit: www.opiant.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed, implied or inferred by these forward-looking statements, including those risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission, including our most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto. Therefore, current and prospective security holders are cautioned that there also can be no assurance that the forward-looking statements included in this press release will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation or warranty by Opiant or any other person that the objectives and plans of Opiant will be achieved in any specified time frame, if at all. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “intends,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” or “continue” or the negative of such terms and other comparable terminology. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. In evaluating these statements, you should specifically consider various factors. These and other factors may cause our actual results to differ materially from any forward-looking statement. We undertake no obligation to update any of the forward-looking statements after the date of this press release to conform those statements to reflect the occurrence of unanticipated events, except as required by applicable law.
[Financial tables to follow]
| Opiant Pharmaceuticals, Inc. | ||||||||
| Consolidated Balance Sheets | ||||||||
| As of April 30, 2017 (Unaudited) and July 31, 2016 | ||||||||
| April 30, 2017 | July 31, 2016 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 9,680,454 | $ | 1,481,393 | ||||
| Accounts receivable | - | 312,498 | ||||||
| Prepaid expenses | 98,911 | 62,404 | ||||||
| Total current assets | 9,779,365 | 1,856,295 | ||||||
| Other assets | ||||||||
| Computer equipment (net of accumulated amortization of $3,842 at April 30, 2017 and $1,016 at July 31, 2016) | 3,695 | 6,521 | ||||||
| Patents and patent applications (net of accumulated amortization of $9,417 at April 30, 2017 and $8,388 at July 31, 2016) | 18,033 | 19,062 | ||||||
| Total assets | $ | 9,801,093 | $ | 1,881,878 | ||||
| Liabilities and Stockholders' Equity (Deficit) | ||||||||
| Liabilities | ||||||||
| Current liabilities | ||||||||
| Accounts payable and accrued liabilities | $ | 1,390,780 | $ | 140,584 | ||||
| Accrued salaries and wages | 1,543,142 | 3,681,250 | ||||||
| Note payable | - | 165,000 | ||||||
| Deferred revenue | 194,800 | 250,000 | ||||||
| Total current liabilities | 3,128,722 | 4,236,834 | ||||||
| Deferred revenue | 2,387,084 | 2,350,000 | ||||||
| Total liabilities | 5,515,806 | 6,586,834 | ||||||
| Stockholders' equity (deficit) | ||||||||
| Common stock; par value $0.001; 1,000,000,000 shares authorized; 2,020,380 shares issued and outstanding at April 30, 2017 and 1,992,433 shares issued and outstanding at July 31, 2016 | 2,020 | 1,992 | ||||||
| Additional paid-in capital | 58,549,055 | 56,478,394 | ||||||
| Accumulated deficit | (54,265,788 | ) | (61,185,342 | ) | ||||
| Total stockholders' equity (deficit) | 4,285,287 | (4,704,956 | ) | |||||
| Total liabilities and stockholders' equity (deficit) | $ | 9,801,093 | $ | 1,881,878 | ||||
| Opiant Pharmaceuticals, Inc. | ||||||||||||
| Consolidated Statements of Operations (Unaudited) | ||||||||||||
| For the three and nine months ended April 30, 2017 and 2016 | ||||||||||||
| For the | For the | |||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||
| April 30, 2017 | April 30, 2016 | April 30, 2017 | April 30, 2016 | |||||||||
| Revenue | ||||||||||||
| Royalty and licensing revenue | $ | - | $ | 2,605,097 | $ | 14,656,142 | $ | 4,785,097 | ||||
| Treatment investment revenue | 18,116 | - | 18,116 | 4,800,000 | ||||||||
| Total revenue | 18,116 | 2,605,097 | 14,674,258 | 9,585,097 | ||||||||
| Operating expenses | ||||||||||||
| General and administrative | 1,995,892 | 1,040,608 | 4,567,898 | 13,155,931 | ||||||||
| Research and development | 1,103,319 | 1,059,627 | 1,889,989 | 2,814,520 | ||||||||
| Selling expenses | 84,375 | 93,000 | 1,322,974 | 302,251 | ||||||||
| Total operating expenses | 3,183,586 | 2,193,235 | 7,780,861 | 16,272,702 | ||||||||
| Income (loss) from operations | (3,165,470 | ) | 411,862 | 6,893,397 | (6,687,605 | ) | ||||||
| Other income (expense) | ||||||||||||
| Interest income (expense), net | 10,673 | - | 9,306 | (11,319 | ) | |||||||
| Income (loss) on foreign exchange | 25,189 | 4,266 | 16,851 | (24,925 | ) | |||||||
| Total other income (expense) | 35,862 | 4,266 | 26,157 | (36,244 | ) | |||||||
| Income (loss) before provision for income taxes | (3,129,608 | ) | 416,128 | 6,919,554 | (6,723,849 | ) | ||||||
| Provision for income taxes | - | - | - | - | ||||||||
| Net income (loss) | $ | (3,129,608 | ) | $ | 416,128 | $ | 6,919,554 | $ | (6,723,849 | ) | ||
| Basic income (loss) per common share | $ | (1.55 | ) | $ | 0.22 | $ | 3.45 | $ | (3.57 | ) | ||
| Diluted income (loss) per common share | $ | (1.55 | ) | $ | 0.15 | $ | 3.07 | $ | (3.57 | ) | ||
| Basic weighted average common shares outstanding | 2,014,141 | 1,916,554 | 2,004,143 | 1,882,088 | ||||||||
| Diluted weighted average common shares outstanding | 2,014,141 | 2,734,760 | 2,251,127 | 1,882,088 | ||||||||
| Opiant Pharmaceuticals, Inc. | |||||||
| Consolidated Statements of Cash Flows (Unaudited) | |||||||
| For the nine months ended April 30, 2017 and 2016 | |||||||
| For the Nine Months Ended | |||||||
| April 30, 2017 | April 30, 2016 | ||||||
| Cash flows used in operating activities | |||||||
| Net income (loss) | $ | 6,919,554 | $ | (6,723,849 | ) | ||
| Adjustments to reconcile net income (loss) to net cash provided by operating activities: | |||||||
| Amortization | 3,855 | 1,187 | |||||
| Issuance of common stock for services | 190,427 | 1,215,719 | |||||
| Stock based compensation from issuance of options | 889,076 | 10,183,555 | |||||
| Stock based compensation from issuance of warrants | 229,360 | - | |||||
| Changes in assets and liabilities: | |||||||
| Increase in prepaid expenses | (36,507 | ) | (37,233 | ) | |||
| Decrease in accounts receivable | 312,498 | - | |||||
| Decrease in deferred revenue | (18,116 | ) | (4,300,000 | ) | |||
| Increase (decrease) in accounts payable | 1,250,196 | (108,639 | ) | ||||
| Increase (decrease) in accrued salaries and wages | (1,376,282 | ) | 501,536 | ||||
| Net cash provided by operating activities | 8,364,061 | 732,276 | |||||
| Cash flows used in investing activities | |||||||
| Purchase of equipment | - | (6,528 | ) | ||||
| Net cash used in investing activities | - | (6,528 | ) | ||||
| Cash flows provided by financing activities | |||||||
| Proceeds from related parties notes payable | - | 151,191 | |||||
| Repayment of related parties notes payable | - | (281,191 | ) | ||||
| Repayment of notes payable | (165,000 | ) | - | ||||
| Investment received in exchange for royalty agreement | - | 1,333,500 | |||||
| Net cash provided (used) by financing activities | (165,000 | ) | 1,203,500 | ||||
| Net increase in cash and cash equivalents | 8,199,061 | 1,929,248 | |||||
| Cash and cash equivalents, beginning of period | 1,481,393 | 434,217 | |||||
| Cash and cash equivalents, end of period | $ | 9,680,454 | $ | 2,363,465 | |||
| Supplemental disclosure | |||||||
| Interest paid during the period | $ | 4,828 | $ | 78,865 | |||
| Taxes paid during the period | $ | - | $ | - | |||
| Non-Cash Transactions | |||||||
| Forgiveness of related party debt | $ | 761,826 | $ | - | |||
| Cashless exercise of options | $ | - | $ | 15 | |||