Start Time: 08:07
End Time: 08:19
NephroGenex Inc. (NRX)
Q2 2014 Earnings Conference Call
August 12, 2014 08:00 AM ET
Pierre Legault - CEO
John Hamill - CFO
Wesley Fox - President and CSO
Good morning, ladies and gentlemen. Thank you for standing by. Welcome to the NephroGenex Second Quarter 2014 Earnings Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. As a reminder, this conference will be recorded and available for replay.
I’d like to introduce your host today, John Hamill, Chief Financial Officer. Please go ahead.
Good morning, everyone and thank you for joining us for our second quarter 2014 earnings conference call. With me today are Pierre Legault, Chief Executive Officer, and Dr. Wesley Fox, Chief Scientific Officer.
We announced our financial results for the second quarter ended June 30, 2014 yesterday after the market closed. You can access the press release on the Investor Relations page of our Web site at www.nephrogenex.com.
Before we begin, I’d like to read the Company's Safe Harbor statement. Comments made during this conference call will contain statements that are or may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding NephroGenex potential income streams, development and commercialization efforts, timelines, availability of data, and potential efficacy and market potential with respect to products and product candidates of the Company and its partners.
These forward-looking statements are subject to risks and uncertainties that could cause actual outcomes and results to differ materially from those in forward-looking statements. Reference of these risks and uncertainties was made in yesterday’s press release and they’re disclosed in more detail in the Company’s most recent filings with the U.S. Securities and Exchange Commission.
Forward-looking statements made during this call reflect the Company’s current views with respect to future events and the Company does not undertake and specifically disclaims any obligation to update or revise these statements. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. When evaluating the Company’s business and securities, investors should give careful consideration to these risks and uncertainties.
With that, I’ll hand the call over to Pierre.
Thank you, John, and good morning, everyone. Thank you for joining us on today’s call. We appreciate the opportunity to update you on the Company’s progress. As you know, we launched our Phase 3 PIONEER study of Pyridorin in diabetic nephropathy, in mid June, and that began enrolling patients who are suffering from this chronic life threatening disease.
We are excited to enter late stage development with this first-in-class compound as it may hold the key to halting or slowing progression of the kidney damage that often leads to end stage renal disease for the -- for these patients.
This is a critical mission given that the treatments available to be estimated 6 million sufferers in the U.S alone are only marginally effective. Pyridorin’s mode of action is unique. The drug targets and scavenges of [ph] [bettering] the pathogenic oxidative chemistries that develops and give (indiscernible) reducing their potential for causing kidney damage.
Our previous Phase 2 study demonstrated a more than 60% treatment effect from patients with mild to moderate level of disease and in patient with advanced disease who are previously established as stable measurement of standard of care. This study is 90% power to detect the 28% treatment effect.
Our clinical team and collaborator -- the Collaborative Study Group at MedPace, led by Chief Scientific Officer, Wes Fox, are well positioned to advance this particular important program. A Special Protocol Assessment with the FDA for a novel fully approvable endpoint in the same patient population is expected to simply reduce the studies time and costs and increase the [ph] [likelihood of success] as compared to -- for obvious trials in this disease.
In the second quarter our clinical team also advanced the Pyridorin TQT cardiac safety study, which is nearly completed. We expect top line results early in the fourth quarter and the full study report by year-end. We also have began the work to initiate preclinical studies with an intravenous form of Pyridorin for use with critical care and other patients who suffer acute kidney injury while being treated in the hospital for other illnesses. This is an important effort as more than 5% of all hospital surgery inpatients are addressed.
At this point, I’d like to turn the call over to John to take you through the second quarter numbers.
Thank you, Pierre. Financial results for the second quarter ended June 30, 2014 were in line with our expectations. Research and development expenses increased to approximately $3.9 million in the quarter from $221,000 in the second quarter of 2013, driven primarily by the planning, the initiation of our Phase 3 Pyridorin program.
General and administrative spending in the second quarter ended June 30, 2014 was approximately $1.6 million versus $154,000 in the second quarter of 2013 due to additional payroll and non-cash compensation expense, and increased costs incurred from operating as a public company.
The net loss in second quarter 2014 was approximately $5.4 million or $0.61 per common share as compared to $803,000, or $2.51 per share in the second quarter of 2013. Our average shares outstanding for the second quarter increased to 8.85 million shares from 320,000 shares in the second quarter of 2013, attributable to our February 2014 initial public offering.
Turning to the balance sheet, total cash, cash equivalents, and short-term investments as of June 30, 2014 were approximately $29.9 million versus approximately $2.1 million at December 31, 2013.
With that, I’ll hand the call over to Wes, for discussion of some upcoming developments.
Thanks, John. As Pierre mentioned, our TQT cardiac study is progressing as planned. Pyridorin dosing and patient follow-up has concluded and data analysis is underway. We expect to report top line TQT cardiac safety results in early October with the full report available by year-end. We’ve also started work on our preclinical studies for intravenous Pyridorin in acute kidney injury. The studies are designed to determine where the therapy could have the most beneficial effect on the severity of acute kidney injury and were scheduled to begin during the third quarter.
Later this year, we’re expecting the publication of the finding from the National Kidney Foundation FDA special scientific workshop on renal endpoint. This workshop examined clinical data from numerous studies of chronic kidney disease to assess the predictability of new renal disease endpoint for end stage renal disease.
The findings of this workshop were considered in establishing the Pyridorin Special Protocol Assessment and the PIONEER protocol, which includes a new renal endpoint and with 50% increase in serum creatinine. Also the PIONEER protocol is expected to be presented at this year’s meeting on the American Society of Nephrology to be held in November in Philadelphia.
Regulatory group has requested a scientific advice meeting with regulatory authorities in Europe to discuss and reach agreement on the new 50% serum creatinine increase renal endpoint being used in the pioneering program. We expect to complete our formal regulatory filing to the EMA by year’s end.
Finally, our clinical and regulatory teams have been planning our approach and objective with the PIONEER interim analysis. We will meet with the FDA in the coming months to finalize this plan.
With that, I’ll hand the call back to Pierre.
Thank you, Wes. To follow-up on the plan interim analysis, we expect to enroll the first 300 patient in the study by early 2015 and complete enrollment of the full 600 patients by next summer. This will allow our data safety monitoring board to perform the interim analysis review during the early part of 2016. We expect this interim analysis to provide us with a sense of what (indiscernible) trial is on track for clinical success.
We currently plan to begin our second Phase 3 trials, following the successful interim analysis. We fully expect our cash resources to carry the Company into the early part of 2016. With the interims in hand, we’d then seek partnership and collaborations that will enable us to continue this with vitally important work.
Before concluding, I’d like to acknowledge our employees for their continued dedication and hard work to make a difference in the life of millions of diabetics who suffer from this chronic kidney disease. And I’d like to thank you, our investor, for your interest and support.
That concludes our remarks. Thank you for taking the time to join us today. And at this time, I’d like to open the call for questions.
Thank you. (Operator Instructions) At this time, I’m not seeing any questions in queue. I’d like to turn the call back over to Mr. Legault.
Okay. Well, thank you. Thanks again for your interest and support in our Company. And everybody have a nice day. Thank you.
Ladies and gentlemen, thank you for your participation in today’s conference. This concludes your program. You may all disconnect. Everyone have a great day.
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