Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN), a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced financial results for the fourth quarter and fiscal year ended December 31, 2015 and provided an update on its 2015 corporate progress and clinical oncology pipeline developments.
“Rexahn made important strides in 2015 in each of our clinical-stage oncology programs,” said Peter D. Suzdak, Ph.D., Chief Executive Officer. “During the year we presented promising interim clinical data for each of our novel oncology programs — RX-3117, Supinoxin™ and Archexin® — supporting the potential anti-cancer effects of these highly-targeted, investigational cancer therapies. Specifically, we presented interim data in September showing early evidence of potential single agent activity of RX-3117 and Supinoxin in ongoing Phase I clinical studies. Additionally, we completed Stage 1 of a Phase IIa clinical study of Archexin, administered in combination with everolimus, to patients with metastatic renal cell carcinoma (mRCC). Data from the dose-ranging (Stage 1) portion of the study have yielded promising evidence suggestive of a potential dose and time-dependent clinical benefit.”
“Based on the encouraging preliminary clinical data obtained thus far, we have commenced the randomized phase (Stage 2) of the Phase IIa Archexin clinical trial and are shortly preparing to declare a maximum tolerated dose for RX-3117 and Supinoxin and commence proof-of-concept Phase Ib/IIa clinical trials to further evaluate the anti-cancer benefits of these promising anti-cancer agents in select patient populations,” said Dr. Suzdak.
2015 Corporate Highlights:
- Published new preclinical data for RX-3117 in the journal, Anticancer Research, demonstrating robust efficacy of RX-3117 against a panel of human cancer cell lines that have demonstrated resistance to gemcitabine
- Expanded leadership team and appointed Dr. Ely Benaim to the newly created position of Chief Medical Officer
- Published new preclinical findings for Supinoxin in the Journal of Cellular Biochemistry describing Supinoxin’s ability to disrupt a novel cancer-promoting cellular pathway, potentially demonstrating a unique mechanism of action for Supinoxin and utility in targeted cancer therapy
- Presented new Supinoxin data at the 2015 American Association for Cancer Research (AACR) Annual Meeting demonstrating a dose-dependent decrease in the migration of human triple negative breast cancer cells, possibly suggesting the utility of Supinoxin in the treatment of malignant tumors
- Identified a potential biomarker for RX-3117 to aid in future clinical trial design
- RX-21101 selected by the National Cancer Institute’s (NCI) Nanotechnology Characterization Laboratory for funding and development of preclinical Investigational New Drug-enabling studies under NCI’s preclinical characterization program
- Appointed former Pfizer executive, Peter Brandt, as Chairman of the Board
- Awarded a patent in Japan for Rexahn’s novel polymer-based drug delivery technology platform
- Presented interim clinical data for RX-3117 and Supinoxin at the 2015 European Cancer Congress showing preliminary evidence of single agent activity of both investigational anti-cancer compounds
- Awarded a U.S. Patent for claims related to the synthesis of RX-3117
- Presented interim clinical data for Archexin at the 14th International Kidney Cancer Symposium showcasing early evidence of potential clinical activity in patients with metastatic renal cell carcinoma (mRCC)
- Completed a $7 million registered direct offering
- Presented new preclinical data for Supinoxin showing potent tumor inhibition in a xenograft mouse model of human triple negative breast cancer (TNBC)
Fourth Quarter and Full Year 2015 Financial Results:
Cash and Investments – Rexahn’s cash and investments totaled approximately $23.4 million as of December 31, 2015, compared to approximately $32.7 million as of December 31, 2014. The decrease in cash and investments during the year ended December 31, 2015 was primarily due to $17.4 million of cash used in operating activities, offset by approximately $8.2 million in proceeds received from the exercise of stock options and the sale of common stock. Rexahn expects that its cash and investments as of December 31, 2015 will be sufficient to fund the company’s cash flow requirements for its current activities into mid-2017. On March 2, 2016, Rexahn completed a registered direct offering of common stock and warrants for gross proceeds of $5.0 million.
R&D Expenses – Research and development expenses were $12.1 million for the year ended December 31, 2015, compared to $7.0 million for the year ended December 31, 2014. The increase in research and development in 2015 is primarily attributable to additional clinical trial and drug manufacturing costs related to ongoing Archexin, Supinoxin and RX-3117 clinical studies, and partially attributable to an increase in personnel expenses.
G&A Expenses – General and administrative expenses for the year ended December 31, 2015 were approximately $6.1 million, compared to $6.3 million for the year ended December 31, 2014. The year over year decrease is primarily attributable to a decrease in professional fees. 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 $18.3 million and $13.3 million for the years ended December 31, 2015 and 2014, respectively. Rexahn’s net loss was $14.4 million, or $0.08 per share, for the year ended December 31, 2015, compared to a net loss of $18.5 million, or $0.11 per share, for the year ended December 31, 2014. Included in the net loss for the years ended December 31, 2015 and 2014 is an unrealized gain (loss) on the fair value of warrants of $4.0 million and ($5.2 million), respectively. The fair value adjustments are primarily a result of the changes in the stock price between reporting periods. (Original Source)
Shares of Rexahn Pharmaceuticals closed last Friday at $0.36. RNN has a 1-year high of $0.81 and a 1-year low of $0.26. The stock’s 50-day moving average is $0.36 and its 200-day moving average is $0.43.
On the ratings front, Rexahn Pharmaceuticals has been the subject of a number of recent research reports. In a report issued on February 26, Roth Capital analyst Joseph Pantginis maintained a Buy rating on RNN. Separately, on February 9, FBR’s Vernon Bernardino reiterated a Buy rating on the stock and has a price target of $3.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joseph Pantginis and Vernon Bernardino have a total average return of -13.2% and -29.1% respectively. Pantginis has a success rate of 30.2% and is ranked #3716 out of 3724 analysts, while Bernardino has a success rate of 21.2% and is ranked #3711.
Rexahn Pharmaceuticals Inc is a clinical stage biopharmaceutical company dedicated to the discovery, development and commercialization of treatments for cancer and other medical needs.