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Biotech / Medical : PolyMedix

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From: tnsaf3/6/2013 10:06:05 PM
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PolyMedix Provides Business Update and Reports Fourth Quarter 2012 Financial Results

RADNOR, Pa., March 6, 2013 (GLOBE NEWSWIRE) -- PolyMedix, Inc. (OTCBB: PYMX), a biotechnology company developing small-molecule drugs designed to mimic the activity of host defense proteins (HDPs) for the treatment of infectious diseases and innate immune disorders, today provided a business update and announced its financial results for the fourth quarter and year ended December 31, 2012.

"While we continue to face a number of significant challenges, we have a plan in place, which if successful, would allow us to resume clinical operations and the execution of our business plan," commented Edward Smith, interim President and Chief Executive Officer of PolyMedix, Inc. "Our primary financing opportunity includes a reverse stock split designed to increase the per share market price of our common stock and to permit a public offering in connection with an anticipated listing of our common stock on The NASDAQ Stock Market. We have called a special meeting of stockholders, to be held March 15, 2013, and are asking our stockholders to vote in favor of the proposal to authorize a reverse stock split of our common stock. To be clear, if the reverse stock split is not approved and if we fail to meet NASDAQ's initial listing requirements, we will not be able to execute on our primary financing opportunity."

As previously announced, the company has implemented a plan to reduce costs and resulting cash outflows, and the company has been evaluating financial and strategic alternatives. If the planned financing or an alternative transaction is not consummated by early April 2013, the company will likely halt operations.

Business Update:

We have delayed the start of our planned clinical studies and have scaled-back our operations, reducing our number of employees from 28 to 17 in January 2013. Nicholas Landekic ceased to serve as our president and chief executive officer on January 30, 2013. We have been working with our secured lender, MidCap Financial SBIC, LP (MidCap), in order to permit us to execute on our planned financing, and in January 2013 granted MidCap additional collateral in the form of a security interest in our intellectual property. The security interest in our intellectual property will be released if we are successful in executing our primary financing opportunity. Our November 2012 meeting and subsequent communications with the Food and Drug Administration (FDA) have resulted in our being poised, subject to adequate financial resources, to proceed with our planned Phase 2B dose optimization study that will evaluate short course (1-3 days) regimens of brilacidin for empiric treatment of acute bacterial skin and skin structure infections (ABSSSI), our regulatory and commercial gateway indication. Led by our Chief Medical Officer, Daniel Jorgensen, MD, MPH, we are prepared to resume clinical operations for brilacidin upon our successfully executing our planned financing. We expect to file an Investigational New Drug Application (IND) with FDA for an oral topical formulation of brilacidin in patients with radiation or chemotherapy induced oral mucositis within the next 60 days. Financial Results

Unaudited financial information as of and for the year ended December 31, 2012 is included in the tables at the end of this press release. As of December 31, 2012, PolyMedix had cash, cash equivalents and investments totaling $2.4 million, and accounts payable and accrued expenses totaling $3.1 million. Additional capital is needed by the Company to fund its capital requirements and continue operations. To meet its capital needs, PolyMedix is considering multiple alternatives, including, but not limited to, additional equity financings, debt financings, corporate collaboration and licensing agreements, and other funding transactions. There can be no assurance that PolyMedix will be able to complete any such transaction on acceptable terms or otherwise.

Grant and contract revenue decreased for the quarter ended December 31, 2012 to $745,000 compared to $937,000 for the same period in 2011. The decrease was due primarily to certain grants and contracts that ended during fiscal year 2012.

Research and development expenses decreased for the quarter ended December 31, 2012 to $2,104,000 compared to $4,849,000 for the same period in 2011. The decrease was due primarily to the delay and scale-back of clinical operations during the second half of 2012. Research and development expenses are expected to decrease in the first quarter of 2013 and until such time as clinical operations for brilacidin are resumed. Much of the drug discovery work on new classes of and uses for HDP-mimetics continues to be supported by a number of grants and research contracts.

General and administrative expenses decreased for the quarter ended December 31, 2012 to $1,463,000 compared to $1,886,000 for the same period in 2011, due primarily to overall operational scale back measures taken in Q4 2012.

Interest expense decreased for the year ended December 31, 2012 to $216,000 compared to $254,000 for the same period in 2011. The decrease was due to decreased outstanding debt and interest rates.
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