Exhibit 99.1
Avenue Therapeutics Reports Third Quarter 2017 Financial Results and Recent Corporate Highlights
New York, NY – November 9, 2017 – Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a Fortress Biotech (NASDAQ: FBIO) Company, today announced financial results and recent corporate highlights for the third quarter ended September 30, 2017.
“We are excited to have dosed the first patient with IV Tramadol in our Phase 3 bunionectomy trial this quarter, and we look forward to reporting topline data from the study in the second quarter of 2018,” said Lucy Lu, MD, Avenue’s President and Chief Executive Officer. “If successful in our clinical trials and approved by the FDA, IV Tramadol would be the only intravenous Schedule IV opioid in the U.S. IV Tramadol fits into and facilitates the trend to minimize usage of conventional narcotics in the post-surgical setting.”
Financial Results:
| · | As of September 30, 2017, Avenue’s cash and short-term investments (certificates of deposit) totaled $26.1 million compared to $0.2 million at December 31, 2016, an increase of $25.9 million year-to-date. |
| · | Research and development expenses were $2.0 million for the third quarter of 2017, compared to $0.2 million for the third quarter of 2016. |
| · | General and administrative expenses were $0.8 million for the third quarter of 2017, compared to $0.2 million for the third quarter of 2016. |
| · | Net loss attributable to common stockholders was $2.9 million, or $0.30 per share, for the third quarter of 2017. This compares to a net loss attributable to common stockholders of $0.5 million, or $0.19 per share, for the third quarter of 2016. |
Recent Corporate Highlights:
| · | In September 2017, Avenue announced that the first patient has been dosed in the pivotal Phase 3 clinical trial of intravenous (IV) tramadol for the management of moderate to moderately severe pain in patients following bunionectomy surgery. |
| · | In August 2017, Avenue appointed Joseph Vazzano as Vice President of Finance and Corporate Controller (principal financial and accounting officer). |
About Avenue Therapeutics
Avenue Therapeutics, Inc. (“Avenue”), a Fortress Biotech Company, is a specialty pharmaceutical company focused on the development and commercialization of intravenous (IV) tramadol for the management of moderate to moderately severe postoperative pain. IV Tramadol may fill a gap in the acute pain market between IV acetaminophen/NSAIDS and IV conventional narcotics. Avenue is currently evaluating IV Tramadol in a pivotal Phase 3 trial for the management of postoperative pain following bunionectomy surgery. Avenue is headquartered in New York City. For more information, visit www.avenuetx.com.
About Fortress Biotech
Fortress Biotech, Inc. (“Fortress”) is a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products. Fortress develops and commercializes products both within Fortress and through certain of its subsidiary companies, also known as Fortress Companies. In addition to its internal development programs, Fortress leverages its biopharmaceutical business expertise and drug development capabilities and provides funding and management services to help the Fortress Companies achieve their goals. Fortress and the Fortress Companies may seek licensings, acquisitions, partnerships, joint ventures and/or public and private financings to accelerate and provide additional funding to support their research and development programs. For more information, visit www.fortressbiotech.com.
Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
Contacts:
Joseph Vazzano, VP, Finance and Corporate Controller
Avenue Therapeutics, Inc.
(781) 652-4500
ir@avenuetx.com
Media Relations
Sarah Hall
Phase IV Communications
(215) 313-5638
sarah@phaseivcommunications.com
AVENUE THERAPEUTICS, INC.
UNAUDITED CONDENSED BALANCE SHEETS
($ in thousands, except for share and per share amounts)
| September 30, | December 31, | |||||||
| 2017 | 2016 | |||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 16,050 | $ | 197 | ||||
| Short-term investments | 10,000 | - | ||||||
| Prepaid expenses | 126 | - | ||||||
| Total Assets | $ | 26,176 | $ | 197 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 1,914 | $ | 506 | ||||
| Accounts payable and accrued expenses - related party | 76 | 1,348 | ||||||
| Interest payable | - | 57 | ||||||
| Accrued interest - related party | - | 346 | ||||||
| Notes payable - related party | - | 2,848 | ||||||
| NSC notes payable, short-term | - | 1,000 | ||||||
| Derivative warrant liability | - | 314 | ||||||
| Total current liabilities | 1,990 | 6,419 | ||||||
| Convertible notes payable, at fair value | - | 200 | ||||||
| NSC notes payable, long-term (net of debt discount of $0 and $174, respectively) | - | 1,826 | ||||||
| Total Liabilities | 1,990 | 8,445 | ||||||
| Commitments and Contingencies | ||||||||
| Stockholders' Equity (Deficit) | ||||||||
| Preferred Stock ($0.0001 par value), 2,000,000 shares authorized | ||||||||
| Class A Preferred Stock, 250,000 shares issued and outstanding as of September 30, 2017 and December 31, 2016 | - | - | ||||||
| Common Stock ($0.0001 par value), 50,000,000 shares authorized | ||||||||
| Common shares; 10,265,174 and 3,257,936 shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively | 1 | 1 | ||||||
| Common stock issuable, 0 and 83,532 shares as of September 30, 2017 and December 31, 2016, respectively | - | 49 | ||||||
| Additional paid-in capital | 38,603 | 105 | ||||||
| Accumulated deficit | (14,418 | ) | (8,403 | ) | ||||
| Total Stockholders' Equity (Deficit) | 24,186 | (8,248 | ) | |||||
| Total Liabilities and Stockholders' Equity (Deficit) | $ | 26,176 | $ | 197 | ||||
AVENUE THERAPEUTICS, INC.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS
($ in thousands, except for share and per share amounts)
| For the Three Months Ended | For the Nine Months Ended | |||||||||||||||
| September 30, | September 30, | September 30, | September 30, | |||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 2,000 | $ | 183 | $ | 2,580 | $ | 1,168 | ||||||||
| General and administration | 848 | 200 | 2,516 | 693 | ||||||||||||
| Loss from operations | (2,848 | ) | (383 | ) | (5,096 | ) | (1,861 | ) | ||||||||
| Interest income | (6 | ) | - | (6 | ) | - | ||||||||||
| Interest expense | 106 | 89 | 294 | 261 | ||||||||||||
| Interest expense - related party | - | 53 | 81 | 132 | ||||||||||||
| Change in fair value of convertible notes payable | - | - | 99 | - | ||||||||||||
| Change in fair value of warrant liabilities | - | 19 | 451 | 108 | ||||||||||||
| Net Loss | $ | (2,948 | ) | $ | (544 | ) | $ | (6,015 | ) | $ | (2,362 | ) | ||||
| Net loss per common share outstanding, basic and diluted | $ | (0.30 | ) | $ | (0.19 | ) | $ | (1.09 | ) | $ | (0.85 | ) | ||||
| Weighted average number of common shares outstanding, basic and diluted | 9,972,663 | 2,848,651 | 5,514,988 | 2,790,674 | ||||||||||||