Rexahn Pharmaceuticals Reports Full Year 2016 Financial Results and Provides Corporate Update
Progressed Three Novel Targeted Anti-Cancer Therapies in Clinical Development
Completed stage 1 and initiated stage 2 of Phase IIa clinical trial of RX-3117 in Relapsed and Refractory Metastatic Pancreatic Cancer
Initiated Phase IIa clinical trial of Archexin® in Metastatic Renal Cell Carcinoma
Initiated Phase IIa trial of RX-3117 in Advanced Bladder Cancer
Dosed first patient in Phase IIa trial of Supinoxin™ in Triple Negative Breast Cancer
ROCKVILLE, Md., Feb. 27, 2017 (GLOBE NEWSWIRE) -- Rexahn Pharmaceuticals, Inc. (NYSE MKT: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, 2016 and provided an update on the Company's clinical development programs.
"In 2016, we made significant progress across our portfolio of drug candidates, setting up a potentially transformative year for the Company in 2017," said Peter D. Suzdak, Ph.D., Chief Executive Officer of Rexahn. "We achieved a major clinical milestone with RX-3117, with the successful completion of the first stage and the initiation of the second stage of the Phase IIa study in pancreatic cancer and we look forward to the final readout of that study in the second half of this year."
"In addition to progressing development of RX-3117 in pancreatic cancer, we also initiated a Phase IIa clinical trial in patients with advanced bladder cancer and expect to report data from the first stage of that study mid-2017," continued Dr. Suzdak. "With RX-3117, we are focusing on cancers where there has been very little innovation in recent years and where there remains a high unmet need for more effective therapies. RX-3117 is a novel, targeted therapy that has the potential to be more effective than current treatments and we are encouraged by the early clinical data to date."
"We have completed our Phase I dose escalating study with Supinoxin™ and have initiated a Phase IIa study in patients with metastatic triple negative breast cancer," continued Dr. Suzdak. "Data from the Supinoxin™ Phase I study were presented at the European Society of Medical Oncology (ESMO) annual congress in October. The updated results show that Supinoxin is safe and well tolerated at the doses tested. Initial signs of clinical activity have been observed in patients with breast, neuro-endocrine, paraganglioma, head and neck and colorectal cancers. We look forward to having an initial readout of the Phase IIa study in triple negative breast cancer in the second half of 2017. We also initiated a Phase IIa study of Archexin® in combination with everolimus in patients with metastatic renal cell carcinoma during 2016 and look forward to reporting on the completed data from this study."
2016 Corporate Highlights:
RX-3117 — Orally administered targeted nucleoside analogue
Supinoxin™ — First-in-class orally administered modulator of the beta catenin pathway
Archexin® — Highly specific Akt-1 inhibitor
Full Year 2016 Financial Results:
Cash and Investments - Rexahn's cash and investments totaled approximately $20.3 million as of December 31, 2016, compared to approximately $23.4 million as of December 31, 2015. The decrease in cash and investments during the year ended December 31, 2016 was primarily due to $13.2 million of cash used in operating activities, offset by an aggregate $10.1 million of proceeds received from registered direct offerings in March and September 2016. Rexahn expects that its cash and investments as of December 31, 2016 will be sufficient to fund the company's cash flow requirements for its current activities through the first half of 2018.
R&D Expenses - Research and development expenses were $10.1 million for the year ended December 31, 2016, compared to $12.1 million for the year ended December 31, 2015. The decrease in research and development in 2016 is primarily attributable to lower drug manufacturing costs due to a significant supply of drug candidates already being available from prior manufacturing campaigns.
G&A Expenses - General and administrative expenses for the year ended December 31, 2016 were approximately $6.3 million, compared to $6.1 million for the year ended December 31, 2015. The year over year increase is primarily attributable to an increase in personnel expenses. General and administrative expenses consist primarily of salaries and related expenses for executive, finance and other administrative personnel, recruitment expenses, professional fees, and other corporate expenses, including business development, investor relations, and general legal activities.
Net Loss - Rexahn's loss from operations was $16.4 million and $18.3 million for the years ended December 31, 2016 and 2015, respectively. Rexahn's net loss was $9.3 million, or $0.04 per share, for the year ended December 31, 2016, compared to a net loss of $14.4 million, or $0.08 per share, for the year ended December 31, 2015. Included in the net loss for the years ended December 31, 2016 and 2015 is an unrealized gain on the fair value of warrants of $5.5 million and 4.0 million, respectively. The fair value adjustments are primarily a result of the changes in the stock price between reporting periods and from the greater number of warrants outstanding in 2016 compared to 2015.
About Rexahn Pharmaceuticals, Inc.
Rexahn Pharmaceuticals Inc. (NYSE MKT: RNN) is a clinical stage biopharmaceutical company dedicated to developing novel, best-in-class 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. Preclinical studies show that certain of Rexahn's product candidates may be effective against multiple types of cancer, drug resistant cancer and difficult-to-treat cancers, and others may augment the effectiveness of current FDA-approved cancer treatments. The Company has a broad oncology pipeline that includes three anti-cancer compounds currently in clinical development: Supinoxin™, RX-3117, and Archexin®, and a novel nanopolymer-based drug delivery platform technology that may increase the bio-availability of FDA-approved chemotherapies. For more information about the Company and its oncology programs, please visit www.rexahn.com.
Contact: LifeSci Advisors, LLC Matthew P. Duffy (212) 915-0685 email@example.com