Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN), a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, is providing an update of its three clinical development programs and financial results for the quarter ending March 31, 2015.
“Rexahn remains very encouraged by the continued progress of the Supinoxin™, RX-3117 and Archexin® clinical development programs. The additional data recently published with RX-3117 and Supinoxin has substantially increased the excitement around both of these programs by the scientific and clinical oncology communities. In these new studies RX-3117 demonstrated its ability to inhibit the growth of gemcitabine-resistant human pancreatic cancer cells in a cancer patient derived xenograft model; while Supinoxin was shown to decrease the expression of a number of related oncogenes and to decrease the migration of human triple negative breast cancer cells in a metastatic cancer model. With the addition of Ely Benaim, M.D., as Chief Medical Officer, Rexahn is planning clinical proof-of-concept studies for both RX-3117 and Supinoxin, which we hope to initiate by the end of 2015,” commented Rexahn’s CEO Peter D. Suzdak, Ph.D.
An ongoing Phase I dose-escalation clinical trial of Supinoxin is designed to evaluate the safety, tolerability, dose-limiting toxicities and maximum tolerated dose (MTD) in cancer patients with solid tumors. Secondary endpoints include pharmacokinetic analysis and evaluating the preliminary anti-tumor effects of Supinoxin. Patients in seven dose groups (25, 50, 100, 150, 225, 300 and 425 mg) have been enrolled, and the MTD has not yet been reached. Depending upon the number of dose groups needed to determine the MTD, Rexahn expects to complete this trial in the first half of 2015. Supinoxin continues to preliminary demonstrate safety and tolerability, requiring higher dose levels than expected to achieve the MTD.
An ongoing Phase Ib dose-escalation clinical trial of RX-3117 is designed to evaluate the safety, tolerability, dose-limiting toxicities and MTD in cancer patients with solid tumors. Secondary endpoints include pharmacokinetic analysis and evaluating the preliminary anti-tumor effects of RX-3117. Patient enrollment has been completed in eight dose groups (30, 60, 100, 150, 200, 500, 1000 and 1500 mg). The MTD of RX-3117 has not yet been achieved. Rexahn expects to complete this trial in the first half of 2015. RX-3117 continues to preliminary demonstrate safety and tolerability, requiring higher dose levels than expected to be tested to achieve the MTD. To date, no dose-limiting toxicities have been associated with RX-3117 treatment.
The Phase IIa proof-of-concept clinical trial of Archexin in metastatic renal cell carcinoma (RCC) patients is ongoing. The first stage of this study is dose ranging, with up to three dose groups with three RCC patients each, to determine the MTD of Archexin in combination with everolimus, an FDAapproved drug for the treatment of RCC. Patient enrollment is ongoing. Rexahn has orphan drug designation for this indication.
Additional Highlights from the First Quarter of 2015:
- Appointed Ely Benaim, M.D. as Chief Medical Officer
- Presented at the Roth Capital Conference, Bio Europe Conference, Bio Asia Conference, Sachs Bio Cancer Forum, BIO CEO & Investor Conference,and Biotech Showcase Conference
- Published additional preclinical results for RX-3117 and Supinoxin™ in the peer reviewed journals Anticancer Research and Journal of Cellular Biochemistry, respectively
- Research coverage was initiated by MLV & Co.
Cash Position – Rexahn’s cash and investments totaled $29.4 million as of March 31, 2015, compared to $32.7 million as of December 31, 2014. The decrease of $3.3 million was primarily due to $4.0 million of cash used in operating activities, offset by $0.7 million in proceeds received from the exercise of stock options. Rexahn expects that its cash and investments as of March 31, 2015 will be sufficient to fund the company’s cash flow requirements for its current activities into the second half of 2016.
R&D Expenses – Research and development expenses were $2.9 million for the three months ended March 31, 2015, compared to $1.3 millionfor the three months ended March 31, 2014. The increase was primarily attributable to expenses related to the advancement of our drug candidates. During the three months ended March 31, 2015, we incurred additional clinical trial and drug manufacturing costs as we have advanced our Phase IIa clinical trial for Archexin, and Phase I clinical trials for RX-3117 and Supinoxin. The increase is also partially attributable to an increase in personnel expenses.
G&A Expenses – General and administrative expenses for the three months ended March 31, 2015 were approximately $1.5 million, roughly the same G&A expenses from the three months ended March 31, 2014. 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 $4.4 million and $2.8 million for the three months ended March 31, 2015 and 2014, respectively. Rexahn’s net loss was $4.3 million, or $0.02 per share, for the three months ended March 31, 2015, compared to a net loss of$14.6 million, or $0.09 per share, for the three months ended March 31, 2014. Included in the net loss for the three months ended March 31, 2015 and 2014 is an unrealized gain (loss) on the fair value of warrants of $0.1 million and $11.7 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 $0.7103 . RNN has a 1-year high of $1.05 and a 1-year low of $0.65. The stock’s 50-day moving average is $0.73 and its 200-day moving average is $0.74.
On the ratings front, MLV & Co. analyst Vernon Bernardino initiated coverage with a Buy rating on RNN and a price target of $1.25, in a report issued on March 20. The current price target implies an upside of 76.0% from current levels.
According to TipRanks.com, Bernardino has a total average return of -13.2%, a 28.1% success rate, and is ranked #3557 out of 3596 analysts.
Rexahn Pharmaceuticals Inc is a clinical stage biopharmaceutical company dedicated to the discovery, development and commercialization of treatments for cancer and other medical needs.