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Rexahn Pharma (RNN) Reports Wider Loss for 2014; Updates on Clinical Development Programs

March 17, 2015 9:04 AM EDT
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Rexahn Pharma (AMEX: RNN) is providing an update of its three clinical development programs and financial results for the year ending December 31, 2014.

"Rexahn remains very encouraged by the continued progress of the Supinoxin™, RX-3117 and Archexin® clinical development programs. 2015 will be a pivotal year for Rexahn as we determine the maximal tolerated dose (MTD) and preliminary efficacy in cancer patients with solid tumors in the ongoing Phase I clinical studies with Supinoxin™ and RX-3117, and initiate subsequent proof-of-concept studies in the clinic," commented Rexahn's Chief Executive Officer Peter D. Suzdak, PhD.

Pipeline Update:

Supinoxin™ (RX-5902)

An ongoing Phase I dose-escalation clinical trial of Supinoxin 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 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 be safe and well tolerated, requiring higher dose levels than expected to be tested to achieve the MTD.

RX-3117

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. The Company expects to complete this trial in the first half of 2015. RX-3117 continues to be safe and well tolerated, 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.

Archexin®

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 FDA approved drug for the treatment of RCC. Patient enrollment is ongoing. Rexahn has orphan drug designation for this indication.

Additional Highlights from 2014:

  • Completed a $20 million registered direct offering
  • Research coverage was initiated by Roth Capital Partners, Brinson Patrick Securities Corporation and Laidlaw & Company
  • Appointed Mark Carthy and Richard (Rick) Rodgers to the Board of Directors
  • Received five new issued patents from the U.S. Patent and Trademark Office and other international patent authorities
  • Received orphan drug designation from the FDA for RX-3117 in pancreatic cancer
  • Presented preclinical data on RX-3117 and RX-21101at the Annual Meeting of the American Association for Cancer Research (AACR)
  • Published additional preclinical results for RX-3117 in the peer reviewed journal, Anticancer Research

Financial Update:

Cash Position - Rexahn's cash and investments totaled $32.7 million as of December 31, 2014, compared to $19.0 million as of December 31, 2013. The increase of $13.7 million was primarily due to $18.6 million in proceeds received from our registered direct public offering, and $6.2 million received from the exercise of stock options and warrants, offset by $11.1 million from net cash used in operating activities. Rexahn expects that its cash and cash equivalents as of December 31, 2014 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 $7.0 million for the year ended December 31, 2014, compared to $3.3 million for the year ended December 31, 2013. The increase was primarily attributable to expenses related to the advancement of our drug candidates during the year ended December 31, 2014. Our Phase I trial for Supinoxin initiated in 2013 continued throughout 2014, Archexin entered a Phase IIa clinical trial in January 2014to study its safety and efficacy in patients with metastatic RCC, and RX-3117 entered a Phase Ib clinical trial in January 2014 to study its safety and efficacy in patients with solid tumors.

G&A Expenses - General and administrative expenses for the year ended December 31, 2014 were approximately $6.3 million compared to $4.7 million for the year ended December 31, 2013. The year over year increase is primarily attributable to an increase in professional fees, personnel and insurance expenses.

Net Loss - Rexahn's loss from operations was $13.3 million and $8.0 million for the years ended December 31, 2014 and 2013, respectively. Rexahn's net loss was $18.5 million, or $0.11 per share, for the year ended December 31, 2014, compared to a net loss of $9.5 million, or $0.07 per share, for the year ended December 31, 2013. Included in net loss for the year ended December 31, 2014 and 2013 is an unrealized loss on the fair value of warrants of $5.2 million and $1.4 million, respectively. The fair value adjustments are primarily a result of the changes in the stock price between reporting periods.



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