NephroGenex, Inc. Reports Year-End 2013 Financial Results

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  • Raised over $37 million in gross proceeds during Feb. 2014 Initial Public Offering

  • Obtained SPA for shortened Phase 3 PIONEER clinical program in diabetic nephropathy

  • Entered into new manufacturing agreement

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:

  • Secured Special Protocol Assessment (SPA) agreement with the FDA for Phase 3 development of Pyridorin to treat diabetic nephropathy. The SPA includes a novel, fully approvable endpoint (50% SCr increase versus 100%) and patient population that will reduce by approximately half the patient follow-up time and cost. We believe that we will be the first company to use this novel endpoint in a Phase 3 trial.
  • Recruited experienced leadership, including Pierre Legault, who served on the Company's board before being appointed as Chief Executive Officer. Mr. Legault formerly served as CEO of U.K. biotech Prosidion Ltd., and has held senior positions with OSI Pharmaceuticals, Eckerd, Sanofi, Hoechst Marion Roussel, Inc., and Marion Merrell Dow, Inc. He currently serves on the Company's board as well as the boards of Forest Laboratories, Inc. and Regado Biosciences. The Company also recruited John P. Hamill to serve as Chief Financial Officer. Mr. Hamill previously served as Co-President and CFO of Savient Pharmaceuticals, Inc., EVP and CFO of PharmaNet Development Group Inc. and CFO of PharmaNet, Inc.
  • Entered into a manufacturing agreement with Patheon Pharmaceuticals Inc. for clinical supply of oral Pyridorin.

"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:

  • Completed during February 2014 an Initial Public Offering of 3,100,000 shares at $12 per share for gross proceeds of $37.2 million through Aegis Capital Corp. Net proceeds were $33.4 million after underwriter discounts, commissions and offering expenses.
  • Initiate first of two Phase 3 studies mid-2014 with oral Pyridorin for diabetic nephropathy;
  • Complete TQT cardiac safety study in the second half of 2014;
  • Complete regulatory filing with EMA for the new renal endpoint to be used in the Pyridorin Phase 3 clinical program;
  • Expect to initiate pre-clinical program with intravenous Pyridorin in acute kidney injury.

Full Year 2013 Financial Results:

  • Net cash and cash equivalents as of December 31, 2013 was $2.1 million as compared to approximately $324,000 as of December 31, 2012.
  • Net Loss: NephroGenex reported a net loss of $6.3 million, or $19.71 per common share, for the year ended December 31, 2013 as compared to $2.9 million, or $9.08 per share for the same year-earlier period. Net loss for 2013 included a change in value of preferred stock warrants expense of $3.4 million or $10.68 per share. (Per share results are reported on a post-split basis.)
  • Research & development expenses were $1.5 million for full year 2013 as compared to $2.4 million for the same year-earlier period, a reduction that reflects the discontinuation of consulting services used to secure new FDA primary endpoint for Phase 3 Pyridorin. This work was largely completed in 2012.
  • General & administrative expenses were approximately $1.0 million for the year ended December 31, 2013 as compared to approximately $350,000 for the same period in 2012, driven primarily by business development activities.

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.

(A Development Stage Company)
Balance Sheets
December 31,
2013 2012
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
(A Development Stage Company)
Statements of Operations
Period From
Year Ended Year Ended May 25, 2004
December 31, December 31, (inception) to
2013 2012 December 31, 2013
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

CONTACT: Investors Gitanjali Jain Ogawa The Trout Group 646-378-2949 Media Brad Miles BMC Communications 646-513-3125

Source:NephroGenex, Inc.