Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a clinical-stage
biopharmaceutical company, today provided an update on the
Company's product development programs and announced financial
results for the second quarter ended June 30, 2018.
Product Development Updates
Bardoxolone Methyl in Rare Forms of Chronic
Kidney Disease
In July, we reported positive one-year results
for the Phase 2 portion of CARDINAL, a study of bardoxolone methyl
(bardoxolone) in patients with chronic kidney disease (CKD) due to
Alport syndrome, and positive final results for the Phase 2
autosomal dominant polycystic kidney disease (ADPKD) cohort of
PHOENIX. In the Phase 2 portion of CARDINAL, bardoxolone
produced a statistically significant improvement in estimated
glomerular filtration rate (eGFR) of 10.4 mL/min/1.73 m2
(p<0.0001) after 48 weeks of treatment, and 4.1 mL/min/1.73 m2
(p<0.05) at Week 52 after withdrawal of active drug for four
weeks (the retained eGFR benefit). Reata collected historical
eGFR data for 22 out of the 25 Phase 2 study patients. The
historical eGFR data demonstrate that the Phase 2 study patients’
kidney function was declining at an average annual rate of 4.2
mL/min/1.73 m2 for three years prior to study entry. The
demonstration of a retained eGFR benefit in patients with Alport
syndrome suggests that bardoxolone may delay or prevent kidney
failure in these patients and that the Phase 3 portion of CARDINAL
is conservatively powered with respect to the key secondary
endpoint of retained eGFR benefit. Enrollment in the Phase 3
portion of CARDINAL is proceeding as planned, and top-line data is
expected to be available in the second half of 2019.
In May 2018, the European Commission granted
Orphan Drug designation for bardoxolone for the treatment of Alport
syndrome. Bardoxolone previously received Orphan Drug
designation for the treatment of Alport syndrome from the FDA.
In the Phase 2 ADPKD cohort of PHOENIX,
bardoxolone produced a statistically and clinically significant,
time-dependent increase in eGFR of 9.3 mL/min/1.73 m2 (p<0.0001)
at Week 12, which was the primary endpoint of the study.
Reata collected historical eGFR data for 29 of the 31 Phase 2
study patients. The historical eGFR data demonstrate that these
patients’ kidney function was declining at an average annual rate
of 4.8 mL/min/1.73 m2 for three years prior to study entry.
In other forms of CKD, changes in eGFR at Week 12 produced by
bardoxolone significantly correlated with eGFR change after one
year of treatment, which suggests that long-term eGFR improvements
and retained eGFR benefit observed in other forms of CKD may
translate to patients with ADPKD. Reata is currently
developing plans to advance the ADPKD program into a pivotal Phase
3 trial.
Enrollment in the IgA nephropathy and type 1
diabetic CKD (T1D CKD) cohorts of PHOENIX was completed in the
second quarter, and we expect full primary endpoint data from these
cohorts to be available during the third quarter of 2018.
Full primary endpoint data from the focal segmental
glomerulosclerosis (FSGS) cohort are expected to be available in
the first half of 2019.
Omaveloxolone in Friedreich’s Ataxia
In July 2018, the European Commission granted
Orphan Drug designation for omaveloxolone for the treatment of
Friedreich’s ataxia (FA). Omaveloxolone previously received
Orphan Drug designation for the treatment of FA from the FDA.
Enrollment in the pivotal Part 2 of the Phase 2
MOXIe trial of omaveloxolone in FA is proceeding as planned, with
top-line data expected in the second half of 2019.
CATALYST Trial of Bardoxolone in CTD-PAH
Enrollment in the pivotal CATALYST Phase 3 trial
of bardoxolone in patients with pulmonary arterial hypertension
associated with connective tissue disease is proceeding as
planned. The trial will enroll a total of approximately 200
patients, with top-line data expected in the first half of
2020.
Upcoming Milestones
- Full 12-week PHOENIX data from the IgA nephropathy cohort and
T1D CKD cohort during the third quarter of 2018
- Full 12-week PHOENIX data from the FSGS cohort in the first
half of 2019
- Pivotal data from the CARDINAL trial in the second half of
2019
- Pivotal data from the MOXIe trial in the second half of
2019
- Pivotal data from the CATALYST trial in the first half of
2020
Financial Highlights
We incurred operating expenses of $34.2 million
for the quarter ended June 30, 2018, with research and development
accounting for $23.4 million. This compares to operating
expenses of $24.0 million for the same period of the year prior,
when research and development accounted for $17.9 million. We
reported a net loss of $28.2 million or $1.08 per share for the
quarter ended June 30, 2018. This compares to net loss of
$11.6 million or $0.52 per share in the same period of the year
prior. The increase in net loss for the three month period is
primarily driven by a decrease in revenue due to full recognition
in 2017 of previously deferred revenue from a license agreement,
increased research and development expenses related to clinical and
manufacturing activities, increased general and administrative
activities due to expenses and fees related to the $30 million
milestone receivable, and a loss on extinguishment of debt due to
the modification of our debt agreement.
We incurred operating expenses of $62.4 million
for the six month period ended June 30, 2018, with research and
development accounting for $44.8 million. This compares to
operating expenses of $43.9 million for the same period of the year
prior, when research and development accounted for $32.5
million. We reported a net loss of $24.1 million or $0.92 per
share for the six month period ended June 30, 2018. This
compares to net loss of $18.7 million or $0.84 per share in the
same period of the year prior.
At June 30, 2018, we had $138.7 million in cash
and cash equivalents. During July, we closed an equity
offering totaling approximately $248 million before fees and
expenses. We believe our existing cash and cash equivalents,
including the net proceeds of approximately $232.9 million received
from our July equity offering and the expected milestone payment of
$30 million from Kyowa Hakko Kirin, will be sufficient to enable us
to fund our operating expenses and capital expenditure requirements
into 2021.
Reata management will host a conference call and
webcast to discuss our development programs on August 8, 2018, at
4:30 p.m. ET at the following:
CONFERENCE CALL INFORMATION |
Date: |
Wednesday, August 8, 2018 |
Time: |
4:30 p.m. ET |
Audience Dial-in (toll-free): |
(844) 348-3946 |
Audience Dial-in (international): |
(213) 358-0892 |
Conference ID: |
4089166 |
Webcast Link: |
https://edge.media-server.com/m6/p/ir8b3wuq |
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
Consolidated Statements of Operations |
|
(Unaudited) |
|
|
|
(in thousands, except share and per share
data) |
|
Collaboration revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License and milestone |
|
$ |
7,519 |
|
|
$ |
12,365 |
|
|
$ |
39,686 |
|
|
$ |
25,094 |
|
Other revenue |
|
|
52 |
|
|
|
441 |
|
|
|
276 |
|
|
|
444 |
|
Total
collaboration revenue |
|
|
7,571 |
|
|
|
12,806 |
|
|
|
39,962 |
|
|
|
25,538 |
|
Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
23,429 |
|
|
|
17,901 |
|
|
|
44,835 |
|
|
|
32,504 |
|
General and administrative |
|
|
10,689 |
|
|
|
5,990 |
|
|
|
17,317 |
|
|
|
11,163 |
|
Depreciation and amortization |
|
|
105 |
|
|
|
109 |
|
|
|
206 |
|
|
|
239 |
|
Total
expenses |
|
|
34,223 |
|
|
|
24,000 |
|
|
|
62,358 |
|
|
|
43,906 |
|
Other
income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investment income |
|
|
357 |
|
|
|
73 |
|
|
|
693 |
|
|
|
154 |
|
Interest expense |
|
|
(903 |
) |
|
|
(468 |
) |
|
|
(1,413 |
) |
|
|
(473 |
) |
Loss on extinguishment of debt |
|
|
(1,007 |
) |
|
|
- |
|
|
|
(1,007 |
) |
|
|
- |
|
Total
other income (expense) |
|
|
(1,553 |
) |
|
|
(395 |
) |
|
|
(1,727 |
) |
|
|
(319 |
) |
Loss
before taxes on income |
|
|
(28,205 |
) |
|
|
(11,589 |
) |
|
|
(24,123 |
) |
|
|
(18,687 |
) |
Provision for taxes on income |
|
|
6 |
|
|
|
2 |
|
|
|
6 |
|
|
|
2 |
|
Net
loss |
|
$ |
(28,211 |
) |
|
$ |
(11,591 |
) |
|
$ |
(24,129 |
) |
|
$ |
(18,689 |
) |
Net
loss per share—basic and diluted |
|
$ |
(1.08 |
) |
|
$ |
(0.52 |
) |
|
$ |
(0.92 |
) |
|
$ |
(0.84 |
) |
Weighted-average number of common shares used in net loss per
share basic and diluted |
|
|
26,178,793 |
|
|
|
22,365,663 |
|
|
|
26,167,033 |
|
|
|
22,358,092 |
|
|
|
June 30, |
|
|
December 31,2017 |
|
|
|
2018 |
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
Condensed Consolidated Balance Sheet Data |
|
|
|
|
|
|
|
|
Cash
and cash equivalents |
|
$ |
138,676 |
|
|
$ |
129,780 |
|
Working capital |
|
|
116,678 |
|
|
|
85,492 |
|
Total
assets |
|
|
174,719 |
|
|
|
135,337 |
|
Term
loan |
|
|
78,591 |
|
|
|
19,614 |
|
Deferred revenue (including current portion) |
|
|
237,386 |
|
|
|
244,438 |
|
Accumulated deficit |
|
|
(363,913 |
) |
|
|
(337,143 |
) |
Total stockholders’
deficit |
|
$ |
(167,874 |
) |
|
$ |
(146,973 |
) |
|
|
|
|
|
|
|
|
|
About Reata Pharmaceuticals,
Inc.
Reata is a clinical-stage biopharmaceutical
company that develops novel therapeutics for patients with serious
or life-threatening diseases by targeting molecular pathways
involved in the regulation of cellular metabolism and
inflammation. Reata’s two most advanced clinical candidates,
bardoxolone and omaveloxolone, target the important transcription
factor Nrf2 that promotes the resolution of inflammation by
restoring mitochondrial function, reducing oxidative stress, and
inhibiting pro-inflammatory signaling.
Forward-Looking Statements
This press release includes certain disclosures
that contain “forward-looking statements,” including, without
limitation, statements regarding the success, cost and timing of
our product development activities and clinical trials, our plans
to research, develop and commercialize our product candidates, and
our ability to obtain and retain regulatory approval of our product
candidates. You can identify forward-looking statements
because they contain words such as “believes,” “will,” “may,”
“aims,” “plans,” and “expects.” Forward-looking statements
are based on Reata’s current expectations and assumptions.
Because forward-looking statements relate to the future, they are
subject to inherent uncertainties, risks, and changes in
circumstances that may differ materially from those contemplated by
the forward-looking statements, which are neither statements of
historical fact nor guarantees or assurances of future
performance. Important factors that could cause actual
results to differ materially from those in the forward-looking
statements include, but are not limited to, (i) the timing, costs,
conduct, and outcome of our clinical trials and future preclinical
studies and clinical trials, including the timing of the initiation
and availability of data from such trials; (ii) the timing and
likelihood of regulatory filings and approvals for our product
candidates; (iii) the potential market size and the size of the
patient populations for our product candidates, if approved for
commercial use, and the market opportunities for our product
candidates; and (iv) other factors set forth in Reata’s filings
with the U.S. Securities and Exchange Commission, including its
Annual Report on Form 10-K, under the caption “Risk Factors.”
The forward-looking statements speak only as of the date made and,
other than as required by law, we undertake no obligation to
publicly update or revise any forward-looking statements, whether
as a result of new information, future events, or otherwise.
Contact:Reata Pharmaceuticals, Inc.(972)
865-2219info@reatapharma.comhttp://news.reatapharma.com
Investor Relations:Vinny JindalVice President,
Strategy(469) 374-8721ir@reatapharma.com
Media:Matt Middleman, M.D.LifeSci Public
Relations(646)
627-8384matt.middleman@lifescipublicrelations.com
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