ADVANCED TWO PROGRAMS INTO PIVOTAL
TRIALS IN 2017
Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (Reata or Company), a
clinical-stage biopharmaceutical company, today announced financial
results for the fourth quarter and full year ended December 31,
2017, and provided an update on the Company's business and product
development programs.
“In 2017, Reata made significant strides towards
our goal of building a deep pipeline of late-stage therapeutics for
rare and life-threatening diseases,” said Warren Huff, Chief
Executive Officer. “We entered 2017 with one pivotal trial in
pulmonary arterial hypertension associated with connective tissue
disease and a broad portfolio of exploratory Phase 2 studies from
which we produced meaningful clinical data and launched pivotal
trials in two additional rare diseases, Alport syndrome and
Friedreich’s ataxia. We begin 2018 with these three pivotal
programs in the clinic and a highly focused Phase 2 program in four
rare forms of CKD underway.”
Pipeline Highlights
In 2017, we launched and completed the Phase 2
portion of the Phase 2/3 CARDINAL study for bardoxolone methyl in
patients with CKD caused by Alport syndrome. In the Phase 2
clinical trial, bardoxolone methyl demonstrated a statistically
significant, mean increase from baseline in kidney function, as
assessed by eGFR, at the 12 week endpoint. On the basis of
the Phase 2 results, we initiated the Phase 3 portion of the
CARDINAL trial, which will enroll approximately 150 patients with
Alport syndrome. The United States Food and Drug
Administration (FDA) has provided guidance that one year data from
the ongoing Phase 3 portion of the trial demonstrating an
improvement in retained eGFR, which is the increase in eGFR versus
placebo after the patients have been taken off drug for four weeks,
may support accelerated approval for bardoxolone methyl.
We began the Phase 2 PHOENIX study in patients
with autosomal dominant polycystic kidney disease, IgA nephropathy,
type 1 diabetic CKD, and focal segmental glomerulosclerosis.
Each cohort will enroll approximately 25 patients to evaluate
the safety and efficacy of bardoxolone methyl treatment for each
rare form of CKD. Enrollment has begun in the trial for each
of the four rare forms of CKD.
We reported positive proof-of-concept data in
the MOXIe trial of omaveloxolone in Friedreich’s ataxia, and we
began the registrational portion of MOXIe in 2017.
Omaveloxolone demonstrated a statistically significant improvement
in modified Friedreich’s Ataxia Rating Scale (mFARS) scores of 3.8
points (p=0.0001) at the optimal dose level versus baseline, and a
placebo-corrected improvement in mFARS scores of 2.3 points
(p=0.06) in Part 1 of the MOXIe trial. The FDA has confirmed
that mFARS is acceptable as the primary endpoint for part 2 of
MOXIe and that it may consider either accelerated or full approval
based upon the overall results of the trial and strength of the
data.
Anticipated Clinical Milestones in 2018
and 2019
- One year retained eGFR benefit data for CARDINAL Phase 2
patients in the third quarter of 2018
- 12 week eGFR data from one or more cohorts of PHOENIX in the
second half of 2018
- CATALYST Phase 3 data in the second half of 2018, pending a
sample size re-calculation in the second quarter of 2018 that could
change expected timing
- CARDINAL Phase 3 data in the second half of 2019
- Data from the registrational part 2 of MOXIe in the second half
of 2019
Fourth Quarter Results
The Company incurred operating expenses of $26.5
million for the quarter ended December 31, 2017, with research and
development accounting for $20.4 million. This compares to
operating expenses of $16.7 million for the same period of the year
prior, when research and development accounted for $11.8
million. A net loss of $16.7 million was reported by the
Company for the quarter ended December 31, 2017, equating to a loss
of $0.64 per share, compared to net loss of $4.1 million or $0.19
per share in the same period of the year prior.
2017 Financial Results
As of December 31, 2017, the Company had $129.8
million in cash and cash equivalents. We believe our existing
cash and cash equivalents, in combination with available debt and
an expected milestone from Kyowa Hakko Kirin, will be sufficient to
enable us to fund our operating expenses and capital expenditure
requirements, assuming the CATALYST sample size re-calculation does
not result in a sample size at the high end of the range, through
registrational data from CATALYST in 2018, and both CARDINAL and
MOXIe in the second half of 2019.
The Company incurred operating expenses of $95.0
million for the 12 months ended December 31, 2017, with research
and development accounting for $71.3 million. This compares
to operating expenses of $56.7 million for the same period of the
year prior, when research and development accounted for $39.5
million. The 67% increase in operating expenses was primarily
due to an 81% research and development expense increase consisting
of $23.9 million in expanded clinical and manufacturing activities,
primarily for CARDINAL, CATALYST, MOXIe, the extension trial for
CATALYST and LARIAT and PHOENIX as well as increased costs in other
clinical and preclinical programs. A net loss of $47.7
million was reported by the Company for the 12 month period ended
December 31, 2017, equating to a loss of $1.99 per share, compared
to net loss of $6.2 million or $0.31 per share in the year
prior. The increased net loss was primarily due to the
increased operating expenses and a decrease in the amount of
deferred revenue recognized in 2017.
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 methyl 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.
Contacts
Corporate: Reata Pharmaceuticals, Inc.(972)
865-2219info@reatapharma.comhttp://news.reatapharma.com
Investor:Vinny JindalVice President,
Strategy(855) 55-REATAir@reatapharma.com
Media:Matt Middleman, M.D.LifeSci Public
Relations(646)
627-8384matt.middleman@lifescipublicrelations.com
|
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|
|
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|
|
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Three Months ended |
|
|
Twelve Months ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
Consolidated Statements of Operations |
|
(in thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License and milestone |
|
$ |
9,509 |
|
|
$ |
12,500 |
|
|
$ |
47,103 |
|
|
$ |
49,730 |
|
Other revenue |
|
|
454 |
|
|
|
1 |
|
|
|
955 |
|
|
|
126 |
|
Total
collaboration revenue |
|
|
9,963 |
|
|
|
12,501 |
|
|
|
48,058 |
|
|
|
49,856 |
|
Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
20,443 |
|
|
|
11,772 |
|
|
|
71,273 |
|
|
|
39,453 |
|
General and administrative |
|
|
5,948 |
|
|
|
4,820 |
|
|
|
23,260 |
|
|
|
16,603 |
|
Depreciation and amortization |
|
|
98 |
|
|
|
145 |
|
|
|
437 |
|
|
|
682 |
|
Total
expenses |
|
|
26,489 |
|
|
|
16,737 |
|
|
|
94,970 |
|
|
|
56,738 |
|
Other
income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investment income |
|
|
350 |
|
|
|
101 |
|
|
|
701 |
|
|
|
214 |
|
Interest expense |
|
|
(498 |
) |
|
|
- |
|
|
|
(1,454 |
) |
|
|
- |
|
Other income (expense) |
|
|
- |
|
|
|
- |
|
|
|
(3 |
) |
|
|
- |
|
Total
other income (expense) |
|
|
(148 |
) |
|
|
101 |
|
|
|
(756 |
) |
|
|
214 |
|
Loss
before taxes on income |
|
|
(16,674 |
) |
|
|
(4,135 |
) |
|
|
(47,668 |
) |
|
|
(6,668 |
) |
Provision (benefit) for taxes on income |
|
|
- |
|
|
|
1 |
|
|
|
3 |
|
|
|
(441 |
) |
Net
loss |
|
$ |
(16,674 |
) |
|
$ |
(4,136 |
) |
|
$ |
(47,671 |
) |
|
$ |
(6,227 |
) |
Net
loss per share—basic and diluted |
|
$ |
(0.64 |
) |
|
$ |
(0.19 |
) |
|
$ |
(1.99 |
) |
|
$ |
(0.31 |
) |
Weighted-average number of common shares used in net loss per
share basic and diluted |
|
|
26,120,324 |
|
|
|
22,337,741 |
|
|
|
23,933,309 |
|
|
|
19,816,635 |
|
|
|
As of December 31, |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
(in thousands) |
|
Condensed Consolidated Balance Sheet Data |
|
|
|
|
|
|
|
|
Cash
and cash equivalents |
|
$ |
129,780 |
|
|
$ |
84,732 |
|
Working capital |
|
|
85,492 |
|
|
|
27,652 |
|
Total
Assets |
|
|
135,337 |
|
|
|
89,093 |
|
Term
Loan |
|
|
19,614 |
|
|
|
- |
|
Deferred revenue (including current portion) |
|
|
244,438 |
|
|
|
291,041 |
|
Accumulated deficit |
|
|
(337,143 |
) |
|
|
(289,354 |
) |
Total stockholders' equity |
|
$ |
(146,973 |
) |
|
$ |
(215,048 |
) |
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