NephroGenex, Inc. (Nasdaq:NRX), a pharmaceutical company focused on the development of therapeutics to treat kidney disease, today reported financial results for the quarter ended March 31, 2014.
“NephroGenex made significant progress in the first quarter. We brought onboard the capabilities of the industry leading Collaborative Study Group and Medpace, and began laying the groundwork for the second quarter launch of our Phase 3 PIONEER program,” said Chief Executive Officer Pierre Legault. “With our Special Protocol Assessment and Fast Track Designation from the FDA, along with these collaborations and successfully completed IPO, the Company is well positioned to advance this important Phase 3 program. Over 6 million diabetics in the U.S. suffer from kidney disease and very few therapeutic options are available.”
Key Q1 2014 Business Highlights:
- Completed Initial Public Offering of 3,100,000 shares at $12 per share for gross proceeds of $37.2 million. Net proceeds were approximately $33.4 million after underwriter discounts, commissions and offering expenses.
- Established CRO partnerships and began preparations for launching the Pyridorin Phase 3 trial with the Collaborative Study Group (CSG), a leading nephrology academic research organization, and Medpace, a contract research organization with expertise in nephrology. Both organizations were instrumental in conducting the Company’s previous Phase 2b study, through which it was able to identify a Phase 3 patient population (where PyridorinTM had a greater than 50% effect) and novel study endpoints accepted by the FDA under a Special Protocol Assessment.
Added Mr. Legault: “Our scientific team, along with our collaborators CSG and Medpace, worked together seamlessly in conducting our Phase 2 studies to forge a clinical strategy and regulatory pathway that put us in a strong position to successfully execute our Phase 3 PIONEER program through to regulatory submission. We look forward to enrolling our first patient in the next several months.”
Q1 2014 Financial Results:
- Net cash and cash equivalents as of March 31, 2014 were $33.5
million as compared to approximately $2.1 million as of December 31,
2013, reflecting the proceeds raised from the Company’s February IPO.
- Net Loss: NephroGenex reported a net loss of approximately $1.7 million, or $0.37 per common share, for the three months ended March 31, 2014 as compared to $474,000, or $1.48 per share for the three months ended March 31, 2013.
- Research & development expenses were approximately $0.5 million for the three months ended March 31, 2014 as compared to $0.3 million for the three months ended March 31, 2013, due to increased effort in preparing to initiate our Phase 3 PIONEER trial.
- General & administrative expenses were approximately $1.0 million for the three months ended March 31, 2014 as compared to approximately $0.1 million for the three months ended March 31, 2013, driven primarily by additional payroll and non-cash compensation expense related to the hiring of additional personnel, increased costs for director and officer liability insurance, and increased costs related to operating as a public company.
Full Year 2014 Business Objectives:
- Initiate first of two Phase 3 studies mid-2014 with 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.
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 PyridorinTM
Pyridorin inhibits pathogenic oxidative chemistries, which are collectively elevated in diabetic patients and induce pathological changes implicated in the development of diabetic nephropathy. Pyridorin inhibits a broad range of these chemistries which we believe accounts for its effectiveness in slowing the progression of nephropathy in diabetic patients as shown in our Phase 2 studies. Our lead drug candidate was also found to be safe and well-tolerated in these same studies.
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) | ||||||||||||||||
| Statements of Comprehensive Loss | ||||||||||||||||
| Cumulative | ||||||||||||||||
| Three | Three | Period From | ||||||||||||||
| Months Ended | Months Ended | May 25, 2004 | ||||||||||||||
| March 31, | March 31, | (inception) to | ||||||||||||||
| 2014 | 2013 | March 31, 2014 | ||||||||||||||
| (unaudited) | (unaudited) | (unaudited) | ||||||||||||||
| Expenses: | ||||||||||||||||
| Research and development | $ | 457,376 | $ | 264,560 | $ | 29,465,241 | ||||||||||
| General and administrative | 1,034,425 | 138,137 | 5,485,469 | |||||||||||||
| Total expenses | 1,491,801 | 402,697 | 34,950,710 | |||||||||||||
| Loss from operations | (1,491,801 | ) | (402,697 | ) | (34,950,710 | ) | ||||||||||
| Other income (expense): | ||||||||||||||||
| Change in value of preferred stock warrants | (140,428 | ) | - | (7,178,162 | ) | |||||||||||
| Interest expense | (78,084 | ) | (71,303 | ) | (1,510,849 | ) | ||||||||||
| Interest income | 9,997 | 176 | 695,720 | |||||||||||||
| Qualifying Therapeutic Discovery Program grant | - | - | 244,479 | |||||||||||||
| Net loss | $ | (1,700,316 | ) | $ | (473,824 | ) | $ | (42,699,522 | ) | |||||||
| Net loss per share - basic and diluted | $ | (0.37 | ) | $ | (1.48 | ) | $ | (140.53 | ) | |||||||
| Weighted average shares outstanding - basic | ||||||||||||||||
| and diluted | 4,587,498 | 319,882 | 303,856 | |||||||||||||
| Comprehensive loss | $ | (1,700,316 | ) | $ | (473,824 | ) | $ | (42,699,522 | ) | |||||||
| NEPHROGENEX, INC. | ||||||||||||
| (A Development Stage Company) | ||||||||||||
| Balance Sheets | ||||||||||||
| March 31, | December 31, | |||||||||||
| 2014 | 2013 | |||||||||||
| (unaudited) | ||||||||||||
| Assets | ||||||||||||
| Current assets | ||||||||||||
| Cash and cash equivalents | $ | 33,513,394 | $ | 2,131,990 | ||||||||
| Prepaid expenses and other assets | 667,782 | 11,711 | ||||||||||
| Total current assets | 34,181,176 | 2,143,701 | ||||||||||
| Property and equipment, net | 13,989 | 10,826 | ||||||||||
| Deferred initial public offering costs | - | 461,079 | ||||||||||
| Other assets | 4,097 | 4,097 | ||||||||||
| Total assets | $ | 34,199,262 | $ | 2,619,703 | ||||||||
| Liabilities and Stockholders' Equity (Deficiency) | ||||||||||||
| Current liabilities | ||||||||||||
| Accounts payable | $ | 76,169 | $ | 47,865 | ||||||||
| Accrued and other liabilities | 707,587 | 1,858,061 | ||||||||||
| Preferred stock warrant liability | - | 6,982,640 | ||||||||||
| Convertible notes payable | - | 7,916,870 | ||||||||||
| Total current liabilities | 783,756 | 16,805,436 | ||||||||||
| Stockholders’ equity (deficiency) | ||||||||||||
| Series A preferred stock: $.001 par value; 32,690,676 shares | ||||||||||||
| authorized; 0 and 23,688,396 shares issued and outstanding | ||||||||||||
| as of March 31, 2014 and December 31, 2013, respectively | - | 23,688 | ||||||||||
| Preferred stock; $.001 par value; 5,000,000 shares | ||||||||||||
| authorized; no shares issued and outstanding | - | - | ||||||||||
| Common stock; $.001 par value; 100,000,000 shares authorized; | ||||||||||||
| 8,855,114 and 319,882 shares issued and outstanding as of | ||||||||||||
| March 31, 2014 and December 31, 2013, respectively | 8,855 | 320 | ||||||||||
| Additional paid-in capital | 76,106,173 | 26,789,465 | ||||||||||
| Deficit accumulated during the development stage | (42,699,522 | ) | (40,999,206 | ) | ||||||||
| Total stockholders’ equity (deficiency) | 33,415,506 | (14,185,733 | ) | |||||||||
| Total liabilities and stockholders’ equity (deficiency) | $ | 34,199,262 | $ | 2,619,703 | ||||||||
Contacts:
The Trout Group
Michael Levitan, 646-378-2920
mlevitan@troutgroup.com
or
Media:
BMC
Communications
Susan Duffy, 646-513-3119
sduffy@bmccommunications.com
