ROCKVILLE, Md., March 08, 2019 (GLOBE NEWSWIRE) -- Rexahn Pharmaceuticals, Inc. (NYSE American: RNN), a clinical stage biopharmaceutical company developing innovative therapies to improve patient outcomes in cancers that are difficult to treat, today announced financial results for year ended December 31, 2018.
2018 and Recent Corporate Highlights:
RX-3117 – Orally administered targeted nucleoside analogue
RX-5902 – Potential first-in-class orally administered modulator of the β-catenin pathway
RX-0301 – Highly specific Akt-1 inhibitor
Corporate
“Rexahn undertook several optimization initiatives in 2018 and early 2019, including streamlining our operations and enhancing the management team and board in order focus our efforts on our highest value opportunities. Our priorities in 2019 will be the continued evaluation of our programs with the goal of building long-term value for our shareholders,” said Douglas J. Swirsky, president and executive officer of Rexahn. “Having completed the enrollment of the Phase 2a combination trial of RX-3117 with ABRAXANE in newly diagnosed metastatic pancreatic cancer patients, we look forward to reporting additional safety and efficacy data later this year.”
2018 Financial Results:
R&D Expenses: Research and development expenses were $13.1 million for the year ended December 31, 2018, compared to $10.7 million for the year ended December 31, 2017. The increase in research and development expenses is primarily attributable to increases in clinical trial costs and patient enrollment costs from the advancement of our RX-3117 and RX-5902 clinical trials, as well as drug manufacturing costs for manufacturing campaigns.
G&A Expenses: General and administrative expenses were $7.4 million for the year ended December 31, 2018 compared to $6.6 million for the year ended December 31, 2017. The increase is primarily attributable to an increase in personnel expenses and severance payments.
Net Loss: Rexahn’s loss from operations was $20.5 million and $17.4 million for the years ended December 31, 2018 and 2017, respectively. Rexahn's net loss was $14.4 million, or $0.44 per share, for the year ended December 31, 2018, compared to a net loss of $25.3 million, or $0.92 per share, for the year ended December 31, 2017. The net loss for the years ended December 31, 2018 and 2017 includes an unrealized gain (loss) on the fair value of warrants of $5.5 million and ($7.6 million), respectively. The fair value adjustments are non-cash charges and are primarily a result of changes in stock price between reporting periods.
About Rexahn Pharmaceuticals, Inc.
Rexahn Pharmaceuticals Inc. (NYSE American: RNN) is a clinical stage biopharmaceutical company developing innovative therapies to improve patient outcomes in cancers that are difficult to treat. The Company’s mission is to improve the lives of cancer patients by developing next-generation cancer therapies that are designed to maximize efficacy while minimizing the toxicity and side effects traditionally associated with cancer treatment. Rexahn’s product candidates work by targeting and neutralizing specific proteins believed to be involved in the complex biological cascade that leads to cancer cell growth. Preclinical studies show that several of Rexahn’s product candidates may be effective against multiple types of cancer, including drug resistant cancers, and difficult-to-treat cancers and others may augment the effectiveness of current FDA-approved cancer treatments. The Company has two oncology product candidates, RX-3117 and RX-5902, in Phase 2 clinical development and additional compounds in preclinical development, including RX-0301. For more information about the Company and its oncology programs, please visit www.rexahn.com.
Safe Harbor
To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, future operations and products, the path of clinical trials and development activities, expected cash flow requirements, and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. These statements also include statements about cash, cash equivalents, and marketable securities as of March 8, 2019 and the sufficiency of those amounts; additional information and disclosures would be required for a more complete understanding of the Company’s financial position and results of operations as of March 8, 2019. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause Rexahn’s actual results to be materially different than those expressed in or implied by Rexahn’s forward-looking statements. For Rexahn, particular uncertainties and risks include, among others, understandings and beliefs regarding the role of certain biological mechanisms and processes in cancer; drug candidates being in early stages of development, including clinical development; the ability to initially develop drug candidates for orphan indications to reduce the time-to-market and take advantage of certain incentives provided by the U.S. Food and Drug Administration; the ability to transition from our initial focus on developing drug candidates for orphan indications to candidates for more highly prevalent indications; and the expecting timing of results from our clinical trials. More detailed information on these and additional factors that could affect Rexahn’s actual results are described in Rexahn’s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K. All forward-looking statements in this news release speak only as of the date of this news release. Rexahn undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Media Contact:
DGI Comm
Susan Forman or Laura Radocaj
+1-212-825-3210
sforman@dgicomm.com
lradocaj@dgicomm.com
Investor Contact:
ir@rexahn.com
(Tables to follow)
Rexahn Pharmaceuticals, Inc.
Condensed Statement of Operations
| For the Year Ended December 31, | ||||||
| 2018 | 2017 | |||||
| Revenues: | $ | - | $ | - | ||
| Expenses: | ||||||
| General and administrative | 7,428,615 | 6,639,421 | ||||
| Research and development | 13,109,058 | 10,715,296 | ||||
| Total Expenses | 20,537,673 | 17,354,717 | ||||
| Loss from Operations | (20,537,673 | ) | (17,354,717 | ) | ||
| Other Income (Expense) | ||||||
| Interest income | 254,344 | 207,003 | ||||
| Other income | 368,750 | - | ||||
| Unrealized gain (loss) on fair value of warrants | 5,546,049 | (7,594,162 | ) | |||
| Financing expense | - | (552,627 | ) | |||
| Total Other Income (Expense) | 6,169,143 | (7,939,786 | ) | |||
| Net Loss Before Provision for Income Taxes | (14,368,530 | ) | (25,294,503 | ) | ||
| Provision for income taxes | - | - | ||||
| Net Loss | $ | (14,368,530 | ) | $ | (25,294,503 | ) |
| Net loss per share, basic and diluted | $ | (0.44 | ) | $ | (0.92 | ) |
| Weighted average number of shares outstanding, basic and diluted | 32,915,377 | 27,390,527 | ||||
Rexahn Pharmaceuticals, Inc.
Selected Balance Sheet Information
| December 31, | December 31, | |||||
| 2018 | 2017 | |||||
| Cash, Cash Equivalents and Marketable Securities | $ | 14,725,821 | $ | 26,831,095 | ||
| Working Capital(1) | $ | 12,747,118 | $ | 24,901,710 | ||
| Total Assets | $ | 16,042,926 | $ | 28,287,881 | ||
| Total Liabilities | $ | 5,480,036 | $ | 11,519,285 | ||
| Stockholders’ Equity | $ | 10,562,890 | $ | 16,768,596 | ||