RADNOR, Pa., Nov. 8, 2012 (GLOBE NEWSWIRE) -- PolyMedix, Inc. (OTCBB:PYMX), a biotechnology company dedicated to transforming the treatment of infectious diseases with novel defensin-mimetic antimicrobials, today announced its financial results for the third quarter ended September 30, 2012 and provided an update on recent key events.
"PolyMedix has had a very busy and productive quarter gearing up for two planned clinical trials, a Phase 2B dose-optimization study with intravenous brilacidin for ABSSSI and a Phase 2 study with brilacidin oral rinse for prevention of oral mucositis in cancer patients," commented Nicholas Landekic, President and CEO of PolyMedix. "Our clinical team has prepared and submitted a comprehensive package to the FDA in advance of our scheduled meeting to discuss our Phase 2B dose-optimization study in ABSSSI patients. We will continue to manage our operations to minimize our cash outflows to extend cash runway."
Business Update:
Brilacidin (formerly PMX-30063) in patients with ABSSSI
Brilacidin in Cancer Oral Mucositis
PolyCide® Antimicrobial Biomaterials
Financial Results
Unaudited financial information at and for the quarter ended September 30, 2012 is included in the tables at the end of this press release. As of September 30, 2012, PolyMedix had cash, cash equivalents and investments totaling $7.1 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 increased for the quarter ended September 30, 2012 to $506,000 compared to $387,000 for the same period in 2011. The increase was attributable to the timing of certain costs under our existing research grants and contracts.
Research and development expenses decreased for the quarter ended September 30, 2012 to $3,177,000 compared to $3,608, 000 for the same period in 2011. The decrease was due primarily to the completion of the phase 2 clinical trial with brilacidin in ABSSSI patients and discontinuation of the two clinical trials with delparantag in the first half of 2012, all of which were ongoing over the same period in 2011. Research and development expenses are expected to decrease in the fourth quarter and until such time as Phase 2 clinical trials for the ABSSSI and cancer oral mucositis indications are able to be initiated. Much of the drug discovery work on new classes of and uses for defensin-mimetics continues to be supported by a number of grants and research contracts.
General and administrative expenses decreased for the quarter ended September 30, 2012 to $1,864,000 compared to $1,926,000 for the same period in 2011.
Interest expense decreased for the quarter ended September 30, 2012 to $215,000 compared to $279,000 for the same period in 2011. The decrease was due to decreased outstanding debt and interest rates.
About PolyMedix, Inc.
PolyMedix is a clinical stage biotechnology company dedicated to transforming the treatment of infectious diseases. PolyMedix is developing a new class of antibiotics – defensin-mimetics – for the treatment of serious, life-threatening infections which often develop resistance to currently available antibiotics. PolyMedix's compounds are designed to imitate the mechanism of action of host defense proteins, which contribute to natural human immunity. In contrast to existing antibiotics, PolyMedix's lead antibiotic compound, brilacidin (formerly PMX-30063), was designed to exploit a method of bacterial cell killing, via biophysical membrane attack, against which bacteria have not shown development of resistance in multiple preclinical studies. Brilacidin showed efficacy similar to an active control, and was safely administered in a Phase 2 clinical trial in patients with acute bacterial skin and skin structure infections (ABSSSI) caused by Staph aureus bacteria (including methicillin-resistant Staphylococcus aureus (MRSA)). PolyMedix has plans to initiate a Phase 2B dose optimization study with brilacidin in ABSSSI patients and also to develop brilacidin as a topical treatment for oral mucositis, a common and often debilitating complication of cancer treatments.
PolyMedix has internally developed an extensive pipeline of compounds including other defensin-mimetic antimicrobial compounds for other infectious diseases such as Gram-negative pathogens, fungal infections, and malaria; PolyCides®, antimicrobial additives to materials to create self-sterilizing products and surfaces; and delparantag (formerly PMX-60056), an anticoagulant reversing agent. PolyMedix's compounds have been internally discovered using a proprietary drug design technology.
For more information, please visit PolyMedix's website at www.polymedix.com.
The PolyMedix, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=10449
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause PolyMedix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. PolyMedix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are PolyMedix's need for, and the availability of, substantial capital to fund its operations, planned clinical trials and research and development, and the fact that PolyMedix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in PolyMedix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. PolyMedix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation. This press release does not constitute an offer of any securities for sale. No securities will be offered or sold absent registration or an applicable exemption from registration requirements.
PolyMedix, Inc. | ||
(A Development Stage Company) | ||
Selected Financial Data (unaudited) | ||
(in thousands, except per share amounts) | ||
September 30, | December 31, | |
2012 | 2011 | |
ASSETS | ||
Cash, cash equivalents and investments | $7,133 | $21,354 |
Other current assets | 479 | 672 |
Property and equipment, net | 356 | 590 |
Long-term assets - other | 141 | 35 |
Total Assets | $8,109 | $22,651 |
LIABILITIES AND STOCKHOLDERS' EQUITY | ||
Accounts payable and accrued expenses | $4,169 | $4,988 |
Long-term debt | 6,716 | 6,550 |
Deferred rent | 801 | 866 |
Derivative liability | 797 | 4,863 |
Total liabilities | 12,483 | 17,267 |
Total stockholders' equity | (4,374) | 5,384 |
Total liabilities and stockholders' equity | $8,109 | $22,651 |
For the period | |||||
August 8, 2002 | |||||
Three-Months Ended | Nine-Months Ended | (Inception) to | |||
September 30, | September 30, | September 30, | |||
2012 | 2011 | 2012 | 2011 | 2012 | |
Revenues: | |||||
Grant and research revenues | $506 | $387 | $1,610 | $1,521 | $10,772 |
Total revenues | 506 | 387 | 1,610 | 1,521 | 10,772 |
Operating Expenses: | |||||
Research and development | 3,177 | 3,608 | 11,182 | 8,926 | 67,873 |
General and administrative | 1,864 | 1,926 | 5,696 | 5,313 | 41,492 |
Total operating expenses | 5,041 | 5,534 | 16,878 | 14,239 | 109,365 |
Other Income and Expenses: | |||||
Interest income | 7 | 21 | 35 | 64 | 1,820 |
Interest expense | (215) | (279) | (677) | (905) | (2,921) |
Gain on derivative instrument | 362 | 1,263 | 3,766 | 563 | 3,416 |
Loss on extinguishment of debt | -- | -- | (309) | -- | (309) |
Total other income (expense) | 154 | 1,005 | 2,815 | (278) | 2,006 |
Net loss | ($4,381) | ($4,142) | ($12,453) | ($12,996) | ($96,587) |
Beneficial conversion feature on Series 2008 preferred stock, conversion inducement and dividends on Series 1 preferred stock | -- | -- | -- | -- | (11,118) |
Net loss attributable to common stockholders | ($4,381) | ($4,142) | ($12,453) | ($12,996) | ($107,705) |
Net loss per common share - basic and diluted | ($0.04) | ($0.04) | ($0.12) | ($0.13) | |
Weighted average common shares outstanding - basic and diluted | 106,790 | 106,000 | 106,559 | 96,808 |