RESEARCH TRIANGLE PARK, N.C., March 31, 2014 (GLOBE NEWSWIRE) -- NephroGenex, Inc. (Nasdaq:NRX), a pharmaceutical company focused on the development of therapeutics to treat kidney disease, today reported financial results for the year ended December 31, 2013, and provided an update on the Company's progress and plans.
"We are extremely pleased with our accomplishments in 2013. NephroGenex is now positioned with the regulatory strategy, resources and leadership needed to successfully launch our pivotal Phase 3 PIONEER development program with Pyridorin™ in diabetic nephropathy," said Chief Executive Officer Pierre Legault. "Our Special Protocol Assessment with the FDA includes the first use of a novel endpoint in diabetic kidney disease, which we believe will significantly reduce the time and cost of a Phase 3 trial compared to previous programs in this indication. Our recently completed IPO and management team appointments enable us to advance Pyridorin's late stage clinical development in an indication affecting 6 million patients in the U.S. alone."
2013 Key Business Milestones:
"With Pyridorin efficacy identified in our target Phase 3 patient population following three large Phase 2 trials, an excellent safety profile, and FDA acceptance of updated study endpoints in diabetic kidney disease, we are well positioned with our Phase 3 PIONEER (PyrIdOriN in DiabEtic NEphRopathy) program in one of the largest commercial markets in the pharmaceutical industry," continued Mr. Legault.
Completed and Upcoming 2014 Milestones:
Full Year 2013 Financial Results:
About Diabetic Nephropathy
Diabetic nephropathy is a chronic, degenerative disease of the kidney caused by diabetes. There are approximately 6 million patients with diabetic nephropathy in the United States (approximately 33% of diagnosed diabetics) and this population is expected to grow. Patients suffering from diabetic nephropathy progress to End Stage Renal Failure (and require dialysis) or death. There are currently no adequate treatments for this disease.
About NephroGenex, Inc.
NephroGenex (Nasdaq:NRX) is a clinical-stage pharmaceutical company focused on developing therapeutics to treat kidney diseases caused by pathogenic oxidative chemistries. Since our inception, we have collaborated with the leading scientific experts in pathogenic oxidative chemistries to build a strong portfolio of intellectual property and novel acting drug candidates. Our clinical program has been done in collaboration with world leading clinical investigators in kidney disease. Our product pipeline includes an oral formulation of Pyridorin, which is being developed as a chronic, therapeutic agent to slow the progression of diabetic nephropathy, as well as an intravenous formulation of Pyridorin to treat specific types of acute kidney injury.
Cautionary Note on Forward-Looking Statements
This press release includes forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in the prospectus related to the initial public offering, and in other filings that NephroGenex may make with the SEC in the future. The forward-looking statements contained in this press release reflect NephroGenex's current views with respect to future events, and NephroGenex does not undertake and specifically disclaims any obligation to update any forward-looking statements.
NEPHROGENEX, INC. | ||
(A Development Stage Company) | ||
Balance Sheets | ||
December 31, | ||
2013 | 2012 | |
Assets | ||
Current assets | ||
Cash and cash equivalents | $ 2,131,990 | $ 323,678 |
Prepaid expenses and other assets | 11,711 | 24,022 |
Total current assets | 2,143,701 | 347,700 |
Property and equipment, net | 10,826 | 3,143 |
Deferred initial public offering costs | 461,079 | -- |
Other assets | 4,097 | 13,586 |
Total assets | $ 2,619,703 | $ 364,429 |
Liabilities and Stockholders' Deficiency | ||
Current liabilities | ||
Accounts payable | $ 47,865 | $ 77,920 |
Accrued and other liabilities | 1,858,061 | 1,334,972 |
Preferred stock warrant liability | 6,982,640 | 3,565,802 |
Convertible notes payable | 7,916,870 | 3,354,822 |
Total current liabilities | 16,805,436 | 8,333,516 |
Stockholders' deficiency | ||
Series A preferred stock: $.001 par value; 32,690,676 shares authorized; 23,688,396 shares issued and outstanding as of December 31, 2013 and 2012 | 23,688 | 23,688 |
Common stock; $.001 par value; 39,751,707 shares authorized; 319,896 shares issued and outstanding as of December 31, 2013 and 2012 | 320 | 320 |
Additional paid-in capital | 26,789,465 | 26,701,448 |
Deficit accumulated during the development stage | (40,999,206) | (34,694,543) |
Total stockholders' deficiency | (14,185,733) | (7,969,087) |
Total liabilities and stockholders' deficiency | $ 2,619,703 | $ 364,429 |
NEPHROGENEX, INC. | |||
(A Development Stage Company) | |||
Statements of Operations | |||
Cumulative | |||
Period From | |||
Year Ended | Year Ended | May 25, 2004 | |
December 31, | December 31, | (inception) to | |
2013 | 2012 | December 31, 2013 | |
Expenses | |||
Research and development | $ 1,479,473 | $ 2,352,181 | $ 29,007,865 |
General and administrative | 1,026,238 | 349,686 | 4,451,044 |
Total expenses | 2,505,711 | 2,701,867 | 33,458,909 |
Loss from operations | (2,505,711) | (2,701,867) | (33,458,909) |
Other income (expense): | |||
Change in value of preferred stock warrants | (3,416,838) | (1,800) | (7,037,734) |
Interest expense | (382,986) | (201,554) | (1,432,765) |
Interest income | 872 | 1,057 | 685,723 |
Qualifying Therapeutic Discovery Program grant | -- | -- | 244,479 |
Net loss and comprehensive loss | $ (6,304,663) | $ (2,904,164) | $ (40,999,206) |
Net loss per share, basic and diluted | $ (19.71) | $ (9.08) | $ (211.37) |
Weighted average shares outstanding, basic and diluted | 319,896 | 319,896 | 193,967 |