- Preclinical data on the potential use of uridine cytidine kinase 2 (UCK2) as a biomarker to predict which patients are most likely to respond to RX-3117 were presented at the American Academy of Cancer Research annual meeting in April 2017.
- Preliminary data on the first ten patients from the Phase 2a study in advanced and metastatic bladder cancer were presented at the American Society for Clinical Oncology meeting in June 2017. The study met the predefined efficacy criteria of an increase in progression free survival of greater than four months, allowing for the enrollment of additional patients. In addition, two patients had a reduction in tumor size of 19% and 15%. Fifty percent of the patients had stable disease for greater than 50 days. RX-3117 treatment was well tolerated in this study with no dose-limiting toxicities.
- Preliminary efficacy data from the Phase 2a clinical study in advanced and metastatic bladder cancer were presented at the European Society of Medical Oncologists (ESMO) meeting in September 2017. Increased progression free survival and evidence of tumor shrinkage were observed in patients with advanced bladder cancer resistant to gemcitabine who had failed multiple prior treatments.
- Preclinical data on RX-3117 presented at the ESMO meeting in September 2017 showed additive and synergistic effects in combination with Abraxane® and with checkpoint inhibitor immunotherapy agents.
- U.S. Patent 9,782,410, "Fluorocyclopentenylcytosine Methods of Use" was issued by the United States Patent and Trademark Office (PTO) in October 2017. The patent covers indications, dosage regimens and pharmacokinetic profile for RX-3117 and is expected to provide protection for RX-3117 to 2036.
- Dosed first patient in a Phase 2a clinical study of RX-3117 in combination with Abraxane® in patients newly diagnosed with metastatic pancreatic cancer in November 2017.
- The European Commission granted Orphan Drug Designation for RX-3117 in pancreatic cancer in January 2018.
- Presented data from the Phase 2a clinical trial of RX-3117 in metastatic pancreatic cancer at the American Society of Clinical Oncology Gastrointestinal Cancers 2018 Annual Meeting. Of the forty-three patients included in the efficacy analysis, 31% had progression free survival for two months or more and five patients, or 12%, had disease stabilization for greater than four months.
- Presented data from the Phase 2a clinical trial of RX-3117 in advanced bladder cancer at the American Society of Clinical Oncology Genitourianry Cancers 2018 Annual Meeting. Encouraging progression free survival and evidence of tumor shrinkage were observed in patients with advanced bladder cancer who had failed on multiple prior treatments including immunotherapy and gemcitabine.
- Completed the Phase 1 dose escalation study of RX-5902 in patients with diverse solid tumors and selected the dose for Phase 2 studies. RX-5902 was well tolerated in this study and the dose-limiting toxicity was moderate fatigue.
- Initiated the Phase 2a study in February 2017 of RX-5902 monotherapy in patients with metastatic triple negative breast cancer (TNBC).
- In August 2017, the PTO issued U.S. Patent 9,744,167, "Nanoparticulate Formulations and Compositions of Piperazine Compounds". The patent covers formulations of RX-5902 and is expected to provide protection to 2034.
- Final data from the Phase 1 dose escalation study in patients with solid tumors were presented in a poster presentation at the ESMO meeting in September 2017. RX-5902 showed preliminary evidence of clinical activity in difficult-to-treat tumors.
- Presented preclinical data in December 2017 at the 40 th Annual San Antonio Breast Cancer Symposium demonstrating potent activity of RX-5902 against patient-derived TNBC tumors in preclinical models. Data presented also demonstrated that RX-5902 enhanced the efficacy of immunotherapy in multiple preclinical models.
- Received notice of allowance from the PTO in January 2018 for a new U.S. patent covering the Use of RX-5902. The allowed Patent Application No. 15/255,901, "Quinoxalinyl Piperazinamide Methods of Use", covers the use of RX-5902 for the treatment of cancers including TNBC either as monotherapy or in combination with other anti-tumor agents such as cytotoxic agents or immune checkpoint inhibitors. The allowed application will extend the patent protection for uses claimed under this patent until 2036.
- Entered into a research and development collaboration with Zhejiang Haichang Biotechnology Co., Ltd. (Haichang) for the development of RX-0201. Under the agreement Haichang will develop a nano-liposomal formulation of RX-0201 using its proprietary QTsome™ technology and conduct certain pre-clinical and clinical activities through completion of a Phase 2 proof-of-concept clinical trial for the treatment of hepatocellular carcinoma.
- Strengthened balance sheet through two financings to institutional investors resulting in gross proceeds of $18 million in June and October 2017.
- Enhanced leadership team by appointing Douglas J. Swirsky as President, Chief Financial Officer and Corporate Secretary in January 2018.
- As of March 9, 2018, had $22.8 million in cash, cash equivalents, and investments (unaudited). Rexahn expects that its cash, cash equivalents, and investments will be sufficient to fund the company's currently expected cash flow requirements for its activities into mid-2019.
Investor contact:LifeSci Advisors, LLCTim McCarthy646.597.6979 email@example.com(Tables to follow) Rexahn Pharmaceuticals, Inc. Condensed Statement of Operations
|For the Year Ended December 31,|
|General and administrative||6,639,421||6,324,236|
|Research and development||10,715,296||10,089,149|
|Loss from Operations||(17,354,717||)||(16,413,385||)|
|Other Income (Expense)|
|Unrealized (loss) gain on fair value of warrants||(7,594,162||)||5,529,907|
|Total Other Income (Expense)||(7,939,786||)||7,106,040|
|Net Loss Before Provision for Income Taxes||(25,294,503||)||(9,307,345||)|
|Provision for income taxes||-||-|
|Net loss per share, basic and diluted||$||(0.92||)||$||(0.43||)|
|Weighted average number of shares outstanding, basic and diluted||27,390,527||21,744,740|
|As of December 31,|
|Cash, Cash Equivalents and Marketable Securities||$||26,831,905||$||20,315,580|
|Working Capital (1)||$||24,901,710||$||19,041,597|
- Working Capital defined as current assets less current liabilities