Rexahn Pharmaceuticals (RNN) Posts Breakeven Q2 Loss; Issues Pipeline Update

Rexahn Pharmaceuticals (AMEX: RNN) reported Q2 EPS of $0.00, $0.02 better than the analyst estimate of ($0.02).

Pipeline Update:

Supinoxin (RX-5902)

In August 2013, Rexahn initiated a Phase I dose-escalation study of Supinoxin designed to evaluate the safety, tolerability, dose-limiting toxicities and maximal tolerated dose (MTD) in cancer patients with solid tumors that have previously failed treatment with approved therapies. Secondary endpoints include pharmacokinetic analysis and evaluating the preliminary anti-tumor effects of Supinoxin. In July, Rexahn announced that four dose groups (25, 50, 100 and 150 mg) had been enrolled. The Company is currently enrolling patients for its fifth dose group (225 mg), and the MTD has not yet been achieved. Depending upon the number of dose groups needed to determine the MTD, Rexahn expects to complete this trial in the fourth quarter of 2014.

RX-3117

Rexahn initiated a Phase Ib clinical trial of RX-3117 in cancer patients with solid tumors in January 2014. The Phase Ib clinical trial is a multi-center dose-escalation study that will evaluate the safety, tolerability, dose-limiting toxicities and MTD of RX-3117 in patients with solid tumors. Secondary endpoints will include characterizing the pharmacokinetic profile of RX-3117 and evaluating the preliminary anti-tumor effects of RX-3117. Patient enrollment has been completed in three dose groups (30, 60 and 100 mg) and is in the middle of recruitment for the fourth dose group (150 mg). The MTD of RX-3117 has not yet been achieved. The Company expects to complete patient enrollment of the RX-3117 Phase Ib clinical trial late in the fourth quarter of 2014 or early 2015. Based on the progress of the RX-3117 clinical development program and the level of interest expressed from a number of oncology-focused pharmaceutical companies, Rexahn is continuing its discussions with multiple companies to explore collaborative business structures in an effort to maximize the potential upside value of the program.

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 its MTD of Archexin in combination with everolimus, an FDA approved drug for the treatment of RCC. Once the MTD has been determined, thirty RCC patients will be randomized to either Archexin in combination with everolimus or everolimus alone, in a ratio of 2:1. Rexahn expects to complete the initial safety component of this study late in the fourth quarter of 2014 or early 2015.

For earnings history and earnings-related data on Rexahn Pharmaceuticals (RNN) click here.

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