- 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)|
|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||--|
|Total assets||$ 2,619,703||$ 364,429|
|Liabilities and Stockholders' Deficiency|
|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|
|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|
|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|
|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)|
|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|