Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN) 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
- Commenced the Phase IIa study in metastatic pancreatic cancer; completed stage 1 of the study in September
- Initiated the second stage of the Phase IIa study in pancreatic cancer in September
- Commenced the first stage of a Phase IIa study in patients with advanced bladder cancer in September
- Extended our patent portfolio with the issuance of a US patent covering the manufacturing process for RX-3117
- Presented final data from the Phase Ib safety and dose-ranging study at the American College of Clinical Oncology (ASCO) Annual Meeting
- Presented interim data from the Phase IIa study in pancreatic cancer at the European Society for Medical Oncology (ESMO) Congress
Supinoxin™ — First-in-class orally administered modulator of the beta catenin pathway
- Completed enrollment in the Phase I dose escalation study in patients with diverse solid tumors.
- Initiated the Phase IIa study in metastatic triple negative breast cancer in February 2017
- Presented updated clinical data from the Phase I study at the American Society of Clinical Oncology (ASCO) annual meeting in June and the European Society of Medical Oncology (ESMO) congress in October. Updated data showed initial signs of clinical activity in patients with breast, neuroendocrine, paraganglioma, head and neck and colorectal cancers.
- Presented new preclinical data in pancreatic and renal cell carcinoma at the American Society of Clinical Oncology (ASCO) annual meeting.
- Presented new preclinical data showing activity in triple negative breast cancer at the Targeted Anti-Cancer Therapeutics (TAT) Congress.
Archexin® — Highly specific Akt-1 inhibitor
- Completed stage 1 of the Phase IIa study in metastatic renal cell carcinoma.
- Initiated the ongoing Phase IIa study comparing Archexin in combination with everolimus versus everolimus alone in patients with renal cell carcinoma.
- Presented final results of stage 1 of the Phase IIa dose escalation study at the American Academy of Cancer Research (AACR) annual meeting.
- Strengthened financial position with the completion of two registered direct offerings for aggregate gross proceeds of $11 million.
- Expanded leadership team and appointed Dr. Lisa Nolan to the newly-created position of Chief Business Officer in July 2016.
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.
Shares of Rexahn are up 5% to $0.25 in pre-market trading Monday. RNN has a 1-year high of $0.39 and a 1-year low of $0.13. The stock’s 50-day moving average is $0.19 and its 200-day moving average is $0.19.
On the ratings front, FBR analyst Vernon Bernardino reiterated a Buy rating on RNN, in a report issued on January 24. According to TipRanks.com, Bernardino has a yearly average loss of 17.3%, a 23% success rate, and is ranked #4429 out of 4501 analysts.
Rexahn Pharmaceuticals, Inc. operates as a clinical stage biopharmaceutical company. It dedicates to the discovery, development and commercialization of innovative treatments for cancer and other medical needs. The firm have three clinical stage oncology candidates: Archexin, RX-3117, and Supinoxin and a robust pipeline of preclinical compounds to treat multiple types of cancer. It has also developed proprietary drug discovery platform technologies in the areas of nano-medicines, 3D gold and times.