[March 24, 2015] |
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NephroGenex Reports Financial Results for the Fourth Quarter and Year Ended December 31, 2014
NephroGenex, Inc. (Nasdaq:NRX), a pharmaceutical company focused on the
development of therapeutics to treat kidney disease, today reported
financial results and business highlights for the fourth quarter and
year ended December 31, 2014.
"NephroGenex achieved important milestones in 2014, including a
successful initial public offering, the launch and advancement of our
pivotal Phase 3 PIONEER program evaluating Pyridorin in diabetic
nephropathy, a favorable TQT cardiac study, and agreement with the FDA
on the design and conduct of the study's interim analysis," said Chief
Executive Officer Pierre Legault. "We also recently gained support from
the European Medicines Agency for our new endpoint and the study's
protocol design, strengthening our global regulatory strategy for this
important program. We believe Pyridorin has the potential to
dramatically improve care for millions of people around the world who
suffer from diabetic kidney disease and have no effective therapeutic
options."
Mr. Legault added, "As we move into 2015, we are expanding the number of
clinical sites in the U.S. and additional countries for enrolling our
Phase 3 PIONEER program, and plan to file an IND and launch the initial
clinical study of an intravenous form of Pyridorin to treat
hospital-acquired acute kidney injury."
Key 2014 and Recent Business Highlights
Clinical Programs
-
Initiated pivotal Phase 3 study in our PIONEER program for oral
Pyridorin®. NephroGenex is currently in
the process of recruiting the study's 600 patients. PYR-311 is a
double-blind, placebo-controlled study to evaluate the safety and
efficacy of Pyridorin in reducing the rate of renal disease
progression in Type 2 diabetic patients. The Company partnered with
two leading research organizations, the Collaborative Study Group and
Medpace, early in 2014 to conduct the Phase 3 PIONEER program. The
product candidate is under a Special Protocol Assessment (SPA) and has
Fast Track designation from the FDA.
-
Reached agreement with the FDA on the design and conduct of the
PYR-311 interim analysis. An unblinded, event-based endpoint
analysis will be conducted after approximately 70 to 90 primary
endpoint events have been observed for Pyridorin therapy after
600 patients have been in the trial for approximately 3 to 6 months.
-
Received support from the European Medicines Agency (EMA (News - Alert)) on
our new endpoint and the study design for our ongoing Phase 3 trial in
diabetic nephropathy. The EMA indicated that the current Phase 3
program could be adequate to support a Marketing Authorization
Application for full market approval in Europe.
-
Successfully completed a QT/QTc (TQT) cardiac safety study on
Pyridorin. Pyridorin showed no effect on the QT interval at the
expected therapeutic dose of 300 mg and at a higher supratherapeutic
dose of 1200 mg.
-
Completed initial preclinical studies evaluating Pyridorin as a
treatment for acute kidney injury (AKI). Pyridorin significantly
reduced the severity of acute kidney injury in an ischemia reperfusion
model, which emulates the AKI that can result following
cardiopulmonary bypass surgery. We are in pre-IND discussions with the
FDA and expect to file an IND and launch the initial clinical study in
the second half of 2015.
Corporate Developments
-
Completed initial public offering (IPO) (February 2014) and closed
on a $12 million term loan facility with East West Bank (November
2014). In the IPO, the Company raised total gross proceeds of
$37.2 million, before underwriting discounts, commissions and offering
expenses totaling $3.8 million. Funds from the term loan are being
used for working capital purposes, including the advancement of the
Company's clinical development programs.
-
Strengthened board of directors with the appointment of Marco
Taglietti, M.D., Chief Executive Officer of Scynexis, Inc. (effective
April 1), and former Executive Vice President, Research and
Development, and Chief Medical Officer of Forest Laboratories, Inc.
Fourth Quarter and Full Year 2014 Financial Results
-
Cash, cash equivalents and short-term investments as of
December 31, 2014 were approximately $28.7 million as compared to
approximately $2.1 million as of December 31, 2013. The increase was
driven primarily by the Company's initial public offering completed in
February 2014. With the addition of clinical sites in the Phase 3
PIONEER program, we expect to have sufficient cash on hand until early
2016.
-
Net loss was $5.3 million, or $0.60 per share, for the fourth
quarter of 2014 and $16.8 million, or $2.15 per share, for the year
ended December 31, 2014, compared to a net loss of $4.1 million, or
$12.99 per share and $6.3 million, or $19.71 per share for the
comparable periods in 2013. Average shares outstanding for 2014 were
7,827,519 shares versus 319,882 shares in 2013.
-
Research and development expenses were approximately $3.8
million in the fourth quarter of 2014 and $11.3 million for the year
ended December 31, 2014, compared to $0.55 million and $1.5 million
for the comparable periods in 2013. The increase in the Company's R&D
spending was primarily due to our Phase 3 clinical development
activities for Pyridorin and an increase in personnel-related expenses.
-
General and administrative expenses were approximately $1.3
million in the fourth quarter of 2014 and $5.3 million for the year
ended December 31, 2014, compared to $0.5 million and $1.0 million for
the comparable periods in 2013. The increase in G&A expenses was
primarily attributable to increased personnel-related expenses
including non-cash compensation expense, increased costs for director
and officer liability insurance, and other costs incurred for
operating as a public company.
Upcoming Business Milestones
-
Expect to increase the number of clinical sites in the PIONEER study
to approximately 150 sites in additional countries by the end of 2015,
with completion of the study's recruitment during the first half of
2016.
-
Anticipate the continued development of I.V. Pyridorin for AKI, with
an IND filing and launch of the initial clinical study during the
second half of 2015.
Conference Call/Webcast Details
NephroGenex will host a conference call and webcast Wednesday, March 25
at 8:00 a.m. Eastern to discuss the Company's financial results and
provide a business update. To access the call, participants should dial
(844) 831-3030 (U.S. domestic) and (315) 625-6887 (international) at
least 10 minutes prior to the start of the call, using passcode
90028581. The event will be webcast live and can also be accessed on the Events
and Presentations section of the Company's website at www.nephrogenex.com.
A replay will be available on the website with the same link
approximately 2 hours after the event for 30 days.
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 Pyridorin®
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. Pyridorin has received FDA Fast Track designation and is
currently being studied in a Phase 3 trial (PIONEER) in patients with
diabetic nephropathy under a special protocol assessment (SPA) with the
FDA.
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 contains certain 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 may
be identified by words such as "expects," "intends," "anticipates,"
"plans," "believes," "seeks," "estimates," "will," or words of similar
meaning and include, but are not limited to, statements regarding the
outlook for our future business and financial performance.
Forward-looking statements are based on our current expectations and
assumptions, which are subject to inherent uncertainties, risks and
changes in circumstances that are difficult to predict. Actual outcomes
and results may differ materially from those in the forward-looking
statements due to global political, economic, business, competitive,
market, regulatory and other factors and risks, including the items
identified under "Part I-Item 1A-Risk Factors" of our Annual Report on
Form 10-K for the year ended December 31, 2014, filed with the
Securities and Exchange Commission ("SEC (News - Alert)") on March 24, 2015, as well as
in other filings that we may make with the SEC in the future. The
forward-looking statements contained in this press release reflect our
current views with respect to future events, and we do not undertake and
specifically disclaim any obligation to update any forward-looking
statements.
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NephroGenex, Inc.
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Balance Sheets
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(In Thousands, Except Share and Per Share Amounts)
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December 31,
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2014
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2013
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Assets
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Current assets
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Cash and cash equivalents
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$
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13,978
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$
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2,132
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Available for sale investments
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14,698
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Prepaid expenses and other assets
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309
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12
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Total current assets
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28,985
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2,144
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Property and equipment, net
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36
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11
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Deferred initial public offering costs
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-
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461
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Other assets
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210
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4
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Total assets
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$
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29,231
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$
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2,620
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Liabilities and Stockholders' Equity (Deficit)
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Current liabilities
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Accounts payable
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$
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1,750
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$
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48
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Accrued and other liabilities
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1,405
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1,858
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Current portion of note payable
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293
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Preferred stock warrant liability
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-
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6,983
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Convertible notes payable
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-
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7,917
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Total current liabilities
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3,448
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16,806
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Note payable, less current portion
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6,442
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-
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Deferred rent
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10
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-
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Total liabilities
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9,900
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16,806
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Stockholders' equity (deficit)
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Series A preferred stock: $.001 par value; 32,690,676 shares
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authorized; 0 and 23,688,396 shares issued and outstanding
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as of December 31, 2014 and December 31, 2013, respectively
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-
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24
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Preferred stock; $.001 par value; 5,000,000 shares
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authorized; no shares issued and outstanding
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-
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-
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Common stock; $.001 par value; 100,000,000 shares authorized;
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8,862,114 and 319,882 shares issued and outstanding as of
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December 31, 2014 and December 31, 2013, respectively
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9
|
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-
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Additional paid-in capital
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77,149
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26,789
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Accumulated other comprehensive loss
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(8
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)
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-
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Accumulated deficit
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(57,819
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)
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(40,999
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)
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Total stockholders' equity (deficit)
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19,331
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(14,186
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)
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Total liabilities and stockholders' equity (deficit)
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$
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29,231
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$
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2,620
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NephroGenex, Inc.
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Statements of Comprehensive Loss
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(In Thousands, Except Share and Per Share Amounts)
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Three
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Three
|
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Months Ended
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Months Ended
|
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Year Ended
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Year Ended
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December 31,
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December 31,
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December 31,
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December 31,
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|
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2014
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2013
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2014
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2013
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Expenses:
|
|
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|
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|
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Research and development
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$
|
3,855
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|
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$
|
545
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|
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$
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11,264
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$
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1,480
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General and administrative
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1,378
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|
504
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5,323
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1,026
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Total expenses
|
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5,233
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|
|
|
1,049
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16,587
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2,506
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|
|
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|
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Loss from operations
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|
|
(5,233
|
)
|
|
|
(1,049
|
)
|
|
|
(16,587
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)
|
|
|
(2,506
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)
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Other income (expense):
|
|
|
|
|
|
|
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Change in value of preferred stock warrants
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|
|
-
|
|
|
|
(2,980
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)
|
|
|
(140
|
)
|
|
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(3,417
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)
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Interest expense
|
|
|
(62
|
)
|
|
|
(125
|
)
|
|
|
(140
|
)
|
|
|
(383
|
)
|
Interest income
|
|
|
13
|
|
|
|
-
|
|
|
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47
|
|
|
|
1
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Net loss
|
|
$
|
(5,282
|
)
|
|
$
|
(4,154
|
)
|
|
$
|
(16,820
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)
|
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$
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(6,305
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)
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|
|
|
|
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Net loss per share - basic and diluted
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$
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(0.60
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)
|
|
$
|
(12.99
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)
|
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$
|
(2.15
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)
|
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$
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(19.71
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)
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|
|
|
|
|
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Weighted average shares outstanding - basic and diluted
|
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8,860,310
|
|
|
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319,882
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|
|
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7,827,519
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|
|
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319,882
|
|
|
|
|
|
|
|
|
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Other comprehensive gain (loss):
|
|
|
|
|
|
|
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Net loss
|
|
|
(5,282
|
)
|
|
|
(4,154
|
)
|
|
|
(16,820
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)
|
|
|
(6,305
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)
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Unrealized gain (loss) on investments
|
|
|
5
|
|
|
|
-
|
|
|
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(8
|
)
|
|
|
-
|
|
Comprehensive loss
|
|
$
|
(5,277
|
)
|
|
$
|
(4,154
|
)
|
|
$
|
(16,828
|
)
|
|
$
|
(6,305
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)
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