On August 7, 2019 Rexahn Pharmaceuticals, Inc. (NasdaqCM: REXN), a clinical stage biopharmaceutical company developing innovative therapies to improve patient outcomes in cancers that are difficult to treat, reported financial results for the three and six months ended June 30, 2019 and provided an update on RX-3117 development (Press release, Rexahn, AUG 7, 2019, View Source [SID1234538306]).

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Recent Highlights and RX-3117 Development Updates:

Announced a collaboration and license agreement with BioSense Global LLC, a New Jersey- and Suzhou, China-based biopharmaceutical company, to advance the development and commercialization of RX-3117 for pancreatic and other cancers in Greater China. Under the agreement, Rexahn will receive an upfront payment, a portion of which has been paid, and will be eligible to receive up to $126 million in development and regulatory milestones and up to $100 million in commercial milestones for each product containing RX-3117, contingent on achieving commercial goals.

As of July 24, 2019, an overall response rate of 23% has been observed in 40 patients that have had at least one scan on treatment in the Phase 2a study of RX-3117 in combination with ABRAXANE (paclitaxel protein-bound particles for injectable suspension) in patients newly diagnosed with metastatic pancreatic cancer. The Company previously reported in January 2019 an overall response rate of 38% in the first 24 patients who had at least one scan on treatment. Preliminary and unaudited data indicates that the median progression free survival for patients in the study is approximately 5.4 months. Patients currently active in the study will continue to be treated and final data from the trial is expected to be available in 2020.

Transferred its stock exchange listing to the Nasdaq Capital Market from its previous listing on NYSE American.

Effected a 1-for-12 reverse stock split of outstanding shares on April 12, 2019.

As of August 7, 2019, had approximately $15.3 million in cash, cash equivalents, and marketable securities (unaudited). Rexahn expects that its cash, cash equivalents and marketable securities will be sufficient to fund the company’s currently expected cash flow requirements for its activities for at least the next 12 months.

"We are surprised and disappointed with the most recent preliminary data from the ongoing Phase 2a trial of RX-3117 in combination with ABRAXANE in first line metastatic pancreatic cancer patients," said Douglas J. Swirsky president and chief executive officer of Rexahn. "RX-3117 appears to be well tolerated and we are evaluating development options for RX-3117 in other indications, including through our collaboration with BioSense. In the near term, we are focused on supporting our collaborations with BioSense and Zhejiang Haichang Biotechnology Co., Ltd. as we evaluate the best path forward for our programs."

See the discussion below under Important Cautionary Statements regarding our cash balance and the other forward-looking statements in this release.

Q2 2019 Financial Results:

R&D Expenses: Research and development expenses were $1.6 million for the three months ended June 30, 2019, compared to $3.4 million for the three months ended June 30, 2018. Research and development expenses were $3.9 million for the six months ended June 30, 2019, compared to $7.5 million for the six months ended June 30, 2018. The decrease in research and development expenses is primarily attributable to decreases in drug manufacturing and clinical trial costs and a reduction in preclinical programs and headcount.

G&A Expenses: General and administrative expenses were $1.3 million for the three months ended June 30, 2019 compared to $1.6 million for the three months ended June 30, 2018. General and administrative expenses were $3.0 million for the six months ended June 30, 2019 compared to $3.4 million for the six months ended June 30, 2018. The decrease is primarily attributable to a decrease in personnel expenses, offset by increases in professional fees.

Net Loss: Rexahn’s loss from operations was $3.0 million and $5.0 million for the three months ended June 30, 2019 and 2018, respectively. Rexahn’s net loss was $2.5 million, or $0.61 per share, for the three months ended June 30, 2019, compared to a net loss of $3.8 million, or $1.45 per share, for the three months ended June 30, 2018. For the six-month period ended June 30, 2019, Rexahn’s net loss was $4.8 million, or $1.23 per share, compared to a net loss of $5.9 million, or $2.24 per share for the six months ended June 30, 2018. The net loss for the six months ended June 30, 2019 and 2018 includes unrealized gains on the fair value of warrants of $1.9 million and $4.5 million, respectively. The fair value adjustments are non-cash charges and are primarily a result of changes in stock price between reporting periods.