ROCKVILLE, Md., Dec. 06, 2018 (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 an operational restructuring that will enable a more efficient development of its clinical-stage oncology pipeline.
Rexahn is lowering its operating costs including eliminating six positions, reducing the company’s workforce to 10. “In order to maximize shareholder value, we are prioritizing our resource utilization, including by reducing overhead expenses and discretionary spending,” said Douglas Swirsky, president and chief executive officer of Rexahn. “These cost reductions are expected to extend our operating runway into the fourth quarter of 2019 and provide further savings in 2020 and beyond. We have retained capabilities to continue the development of RX-3117 and RX-5902 as we explore opportunities to extract full value from these programs.”
The company intends to primarily focus its near-term efforts on the ongoing Phase 2 clinical trial of RX-3117 in combination with ABRAXANE® (nab-paclitaxel) in patients newly diagnosed with metastatic pancreatic cancer. Encouraging preliminary safety and efficacy data from this trial was presented in October at the 5th NCI Pancreatic Cancer Symposium. Updated data from this study will be presented at the American Society of Clinical Oncology Annual Gastrointestinal Cancers Symposium (ASCO-GI) being held January 17-19, 2019 in San Francisco, CA.
In the ongoing Phase 2 RX-3117 study in advanced bladder cancer, Rexahn has completed enrollment of 30 evaluable patients and will finalize the data once all patients in the study have completed treatment, which is expected during the first half of 2019. “We are currently evaluating development pathways for RX-3117 in bladder cancer to optimize positioning for future commercialization and potential partnering,” said Lisa Nolan, Ph.D., chief business officer of Rexahn. “We look forward to providing updated data from this study next year.”
Rexahn is also updating the estimated date of first patient enrollment in the trial of RX-5902 and KEYTRUDA® (pembrolizumab) in triple negative breast cancer (TNBC) to the second half of 2019 from the previous estimate of early 2019. “We are encouraged by pre-clinical data showing that RX-5902 makes cancer cells more susceptible to anti-PD-1 therapy,” said Mr. Swirsky, “We look forward to making the needed financial commitments to initiate the Phase 2 clinical trial in TNBC in 2019 as additional resources become available.” The company intends to cease enrollment in the ongoing Phase 2 study of RX-5902 as monotherapy for patients who have failed multiple prior chemotherapeutic regimens in order to focus RX-5902 development activities on the planned combination trial with KEYTRUDA.
In connection with the restructuring, Rexahn will also eliminate certain pre-clinical activities. Rexahn is continuing its collaboration with Zhejiang Haichang Biotechnology Co., Ltd., to develop RX-0201for the treatment of hepatocellular carcinoma. As of December 2, 2018, Rexahn had $16.0 million in cash, cash equivalents and investments (unaudited).
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. ABRAXANE is a registered trademark of Abraxis Bioscience, LLC, a wholly owned subsidiary of Celgene Corporation.
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-0201. 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, 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, expected results of the Company’s planned cost reductions, 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; the availability and access to capital; 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 and the subsequent quarterly reports on Form 10-Q. 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.
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