ROCKVILLE, Md., March 12, 2018 (GLOBE NEWSWIRE) -- Rexahn Pharmaceuticals, Inc. (NYSE American:RNN), a clinical stage biopharmaceutical company developing innovative, targeted therapeutics for the treatment of cancer, today announced financial results for the year ended December 31, 2017.
"We continue to make significant progress in the development of our product candidates," said Peter D. Suzdak, Ph.D., chief executive officer of Rexahn. "In 2017, we advanced RX-5902 into a Phase 2a trial in triple negative breast cancer and initiated a Phase 2a trial of RX-3117 in patients newly diagnosed with metastatic pancreatic cancer. Importantly, data presented last year demonstrated that RX-5902 enhanced the efficacy of immunotherapy agents in multiple preclinical models. In addition, we recently extended the intellectual property position on RX-3117 and RX-5902 and strengthened our leadership team. We also announced a collaboration to advance RX-0201 using non-dilutive capital through a proof of concept trial in hepatocellular carcinoma."
Dr. Suzdak added, "Our priorities in 2018 will be continued clinical development of RX-3117 and RX-5902. We expect key data readouts this year to include interim data from the Phase 2a combination trial of RX-3117 with Abraxane® in newly diagnosed metastatic pancreatic cancer patients, and interim data from the Phase 2a trial of RX-5902 in patients with triple negative breast cancer."
2017 and Recent Corporate Highlights:
RX-3117 — Orally administered targeted nucleoside analogue
RX-5902 (Supinoxin™) — Potential first-in-class orally administered modulator of the β- catenin pathway
RX-0201 (Archexin®) — Highly specific Akt-1 inhibitor
2017 Financial Results:
R&D Expenses - Research and development expenses increased 6.2% to $10.7 million in 2017 from $10.1 million in 2016, primarily attributable to increased clinical trial costs related to the progression of Rexahn's Phase 2a proof-of-concept clinical trials for RX-3117.
G&A Expenses - General and administrative expenses increased 5.0% to $6.6 million in 2017 from $6.3 million in 2016, primarily due to an increase in personnel expenses and professional fees.
Net Loss - Rexahn's loss from operations was $17.4 million and $16.4 million for the years ended December 31, 2017 and 2016, respectively. Rexahn's net loss was $25.3 million, or $0.92 per share, for the year ended December 31, 2017, compared to a net loss of $9.3 million, or $0.43 per share, for the year ended December 31, 2016. Included in the net loss for the years ended December 31, 2017 and December 31, 2016 is an unrealized (loss) gain on the fair value of warrants of ($7.6 million) and $5.5 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 dedicated to developing novel, targeted therapeutics for the treatment of cancer. 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. Pre-clinical studies show that certain 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-0201. For more information about the Company and its oncology programs, please visit www.rexahn.com.
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, statements about Rexahn's plans, objectives, expectations and intentions with respect to cash flow requirements, future operations and products, enrollments in clinical trials, the path of clinical trials and development activities, and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," and other words of similar meaning or the use of future dates. 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 expected 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.
LifeSci Advisors, LLC
(Tables to follow)
Rexahn Pharmaceuticals, Inc.
Condensed Statement of Operations
|For the Year Ended December 31,|
|General and administrative||6,639,421||6,324,236|
|Research and development||10,715,296||10,089,149|
|Loss from Operations||(17,354,717||)||(16,413,385||)|
|Other Income (Expense)|
|Unrealized (loss) gain on fair value of warrants||(7,594,162||)||5,529,907|
|Total Other Income (Expense)||(7,939,786||)||7,106,040|
|Net Loss Before Provision for Income Taxes||(25,294,503||)||(9,307,345||)|
|Provision for income taxes||-||-|
|Net loss per share, basic and diluted||$||(0.92||)||$||(0.43||)|
|Weighted average number of shares outstanding, basic and diluted||27,390,527||21,744,740|
Rexahn Pharmaceuticals, Inc.
Selected Balance Sheet Information
|As of December 31,|
|Cash, Cash Equivalents and Marketable Securities||$||26,831,905||$||20,315,580|