Completed Rolling Submission of NDA for Omaveloxolone for
Treatment of Patients with Friedreich’s Ataxia; Actively Preparing
for Commercial Launch
Updates Outcome of Type A Meeting with the FDA on the
Protocol Amendment for FALCON
Reaffirms Cash Runway Through end of 2024
Conference Call with Management on May 10, 2022, at 8:30 a.m.
ET
Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the
“Company,” “our,” “us,” or “we”), a clinical-stage
biopharmaceutical company, today announced financial results for
the first quarter of 2022 and provided an update on the Company’s
business operations and clinical development programs.
“We are pleased to have recently completed rolling submission of
a New Drug Application (“NDA”) for omaveloxolone for the treatment
of patients with Friedreich’s ataxia in the United States,” said
Warren Huff, Reata’s Chief Executive Officer. “Friedreich’s ataxia
is a rare, genetic, debilitating, and degenerative neuromuscular
disorder with no approved therapies, and we are looking forward to
working with the U.S. Food and Drug Administration (“FDA”) on its
review of our NDA throughout this year. If approved, we are
preparing to be in a position to launch this important drug by
early 2023.”
Recent Company Highlights
Neurology
Omaveloxolone in Patients with Friedreich’s Ataxia
The FDA has granted Fast Track Designation, Orphan Drug
Designation, and Rare Pediatric Disease Designation to
omaveloxolone for the treatment of Friedreich’s ataxia. In March
2022, we completed the rolling submission of an NDA to the FDA for
omaveloxolone for the treatment of patients with Friedreich’s
ataxia. This NDA is supported by the efficacy and safety data from
the MOXIe Part 2 trial and additional supporting data from the
MOXIe Part 1 and MOXIe Extension trials.
We have secured an agreement on our Pediatric Investigation Plan
with the European Medicines Agency (“EMA”) Pediatric Committee, and
we are continuing to complete the regulatory procedures and
submissions required prior to filing a Marketing Authorization
Application (“MAA”) in Europe for approval of omaveloxolone for the
treatment of patients with Friedreich’s ataxia. We plan to submit
an MAA to the EMA in the fourth quarter of 2022.
Chronic Kidney Disease
Bardoxolone Methyl in Autosomal Dominant Polycystic Kidney
Disease
We are currently enrolling patients in FALCON, a Phase 3,
international, multi-center, randomized, double-blind,
placebo-controlled trial studying the safety and efficacy of
bardoxolone methyl (“bardoxolone”) in patients with autosomal
dominant polycystic kidney disease (“ADPKD”) randomized one-to-one
to active drug or placebo. FALCON is enrolling patients in a broad
range of ages with an estimated glomerular filtration rate (“eGFR”)
between 30 and 90 mL/min/1.73 m2. More than 550 patients are
currently enrolled in the trial.
In the first quarter of 2022, we submitted a protocol amendment
to the FALCON Phase 3 trial of bardoxolone in patients with ADPKD
with the FDA and other relevant health authorities. We recently met
with the FDA in a Type A meeting to discuss our protocol amendment.
Based on the discussion during the meeting and the meeting minutes,
the Division stated that the proposed primary endpoint of eGFR
change from baseline at Week 108 (8 weeks after planned drug
discontinuation at Week 100) was reasonable since the available
data suggest that bardoxolone’s acute pharmacodynamic effect on
eGFR should be largely resolved. The FDA also confirmed that, if
the FALCON trial is positive, it could support registration of
bardoxolone in ADPKD.
First Quarter Financial Highlights
Cash and Cash Equivalents
On March 31, 2022, we had cash and cash equivalents of $532.0
million, as compared to $590.3 million on December 31, 2021.
GAAP and Non-GAAP Research and Development (“R&D”)
Expenses
R&D expenses according to generally accepted accounting
principles in the U.S. (“GAAP”) were $39.8 million for the first
quarter of 2022, as compared to $34.9 million for the same period
of the year prior. The increase is primarily due to personnel and
personnel-related costs to support the product development
activities.
Non-GAAP R&D expenses were $32.2 million for the first
quarter of 2022, as compared to $28.1 million for the same period
of the year prior.1
GAAP and Non-GAAP General and Administrative (“G&A”)
Expenses
GAAP G&A expenses were $24.8 million for the first quarter
of 2022, as compared to $20.7 million for the same period of the
year prior. The increase is primarily due to rent expense related
to the new headquarters building lease that commenced in December
2021.
Non-GAAP G&A expenses were $17.0 million for the first
quarter of 2022, as compared to $12.8 million for the same period
of the year prior.1
GAAP and Non-GAAP Net Loss
The GAAP net loss for the first quarter of 2022 was $73.8
million, or $2.03 per share, on both a basic and diluted basis, as
compared to a GAAP net loss of $67.5 million, or $1.86 per share,
on both a basic and diluted basis, for the same period of the year
prior.
The non-GAAP net loss for first quarter of 2022 was $48.5
million, or $1.33 per share on both a basic and diluted basis, as
compared to a non-GAAP net loss of $41.9 million, or $1.16 per
share, on both a basic and diluted basis, for the same period of
the year prior.1
Updated Cash Guidance
The Company reaffirms its existing cash and cash equivalents
will be sufficient to enable it to fund operations through the end
of 2024.
___________________________
1 See “Non-GAAP Financial Measures” below for a description of
non-GAAP financial measures and a reconciliation between GAAP and
non-GAAP R&D expenses, GAAP and non-GAAP G&A expenses, and
GAAP and non-GAAP net loss, respectively, appearing later in the
press release.
Non-GAAP Financial Measures
This press release contains non-GAAP financial measures,
including non-GAAP R&D expenses, non-GAAP G&A expenses,
non-GAAP operating expenses, non-GAAP net loss and non-GAAP net
loss per common share – basic and diluted. These measures are not
in accordance with, or an alternative to, GAAP, and may be
different from non-GAAP financial measures used by other
companies.
The Company defines non-GAAP R&D expenses as GAAP R&D
expenses, which exclude stock-based compensation expense; non-GAAP
G&A expenses as GAAP G&A expenses, which exclude
stock-based compensation expense; non-GAAP operating expenses as
GAAP operating expenses, which exclude stock-based compensation
expense; non-GAAP net loss as GAAP net loss, which excludes
stock-based compensation expense and non-cash interest expense from
liability related to sale of future royalties; and non-GAAP net
loss per common share – basic and diluted as GAAP net loss per
common share – basic and diluted, which excludes stock-based
compensation expense and non-cash interest expense from liability
related to sale of future royalties. The Company has excluded the
impact of stock-based compensation expense, which may fluctuate
from period to period based on factors including the variability
associated with performance-based grants for stock options and
restricted stock units and changes in the Company’s stock price,
which impacts the fair value of these awards. The Company has
excluded the impact of accreted non-cash interest expense from
liability related to sale of future royalties as it may be
calculated differently from, and therefore may not be comparable
to, peer companies who also provide non-GAAP disclosures. The
Company has excluded the impact of stock-based compensation expense
and non-cash interest expense from liability related to sale of
future royalties because the Company believes its impact makes it
difficult to compare its results to prior periods and anticipated
future periods.
Because management believes certain items, such as stock-based
compensation expense and non-cash interest expense from liability
related to sales of future royalties, can distort the trends
associated with the Company’s ongoing performance, the following
measures are often provided, excluding special items, and utilized
by the Company’s management, analysts, and investors to enhance
consistency and comparability of year-over-year results, as well as
to industry trends, and to provide a basis for evaluating operating
results in future periods: non-GAAP net loss; non-GAAP net loss per
common share – basic and diluted; non-GAAP R&D expenses;
non-GAAP G&A expenses; and non-GAAP operating expenses.
The Company believes the presentation of these non-GAAP
financial measures provides useful information to management and
investors regarding the Company’s financial condition and results
of operations. When GAAP financial measures are viewed in
conjunction with these non-GAAP financial measures, investors are
provided with a more meaningful understanding of the Company’s
ongoing operating performance and are better able to compare the
Company’s performance between periods. In addition, these non-GAAP
financial measures are among those indicators the Company uses as a
basis for evaluating performance, allocating resources, and
planning and forecasting future periods. These non-GAAP financial
measures are not intended to be considered in isolation or as a
substitute for GAAP financial measures. A reconciliation between
these non-GAAP measures and the most directly comparable GAAP
measures is provided later in this press release.
Conference Call Information
Reata’s management will host a conference call on May 10, 2022,
at 8:30 a.m. ET. The conference call will be accessible by dialing
(844) 200-6205 (toll-free domestic) or (929) 526-1599
(international) using the access code 488160. The webcast link is
https://services.choruscall.com/mediaframe/webcast.html?webcastid=MTgDXzgf.
First quarter 2022 financial results to be discussed during the
call will be included in an earnings press release that will be
available on the Company’s website shortly before the call at
https://www.reatapharma.com/investors/ and will be available for 12
months after the call. The audio recording and webcast of the
conference call will be accessible for at least 90 days after the
event at https://www.reatapharma.com/investors/.
About Reata
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, omaveloxolone and
bardoxolone, target the important transcription factor Nrf2 that
promotes the resolution of inflammation by restoring mitochondrial
function, reducing oxidative stress, and inhibiting
pro-inflammatory signaling. Omaveloxolone and bardoxolone are
investigational drugs, and their safety and efficacy have not been
established by any agency.
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, our plans to
submit regulatory filings, 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,” “model,” 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) whether regulatory authorities determine that
additional trials or data are necessary in order to obtain
approval; (iv) 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 (v) other factors set forth in Reata’s filings with
the U.S. Securities and Exchange Commission, including its Annual
Report on Form 10-K for the fiscal year ended December 31, 2021,
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.
Three Months Ended
March 31
2022
2021
Consolidated Statements of
Operations
(unaudited)
(in thousands, except share
and per share data)
Collaboration revenue
License and milestone
$
893
$
795
Other revenue
21
149
Total collaboration revenue
914
944
Expenses
Research and development
39,804
34,880
General and administrative
24,841
20,704
Depreciation
308
274
Total expenses
64,953
55,858
Other income (expense), net
(9,772
)
(12,556
)
Loss before taxes on income
(73,811
)
(67,470
)
Benefit from (provision for) taxes on
income
(31
)
15
Net loss
$
(73,842
)
$
(67,455
)
Net loss per share—basic and diluted
$
(2.03
)
$
(1.86
)
Weighted-average number of common shares
used in net loss per share basic and diluted
36,412,621
36,203,631
As of
As of
March 31, 2022
December 31, 2021
(in thousands)
Condensed Consolidated Balance Sheet
Data
Cash and cash equivalents
$
531,979
$
590,258
Working capital
493,716
542,481
Operating lease right-of-use assets
131,178
126,777
Total assets
679,868
735,016
Liability related to sale of future
royalties, net
372,013
362,142
Operating lease liabilities
141,587
136,033
Deferred revenue
755
1,648
Accumulated deficit
(1,329,473
)
(1,255,631
)
Total stockholders’ equity
$
127,785
$
185,989
Reconciliation of GAAP to Non-GAAP Financial Measures
The following table presents reconciliations of non-GAAP
financial measures to the most directly comparable GAAP financial
measures (in thousands, except for per share data):
Three Months Ended
March 31
2022
2021
Reconciliation of GAAP to Non-GAAP
Research and development:
(unaudited)
GAAP Research and development
$
39,804
$
34,880
Less: Stock-based compensation expense
(7,606
)
(6,808
)
Non-GAAP Research and development
$
32,198
$
28,072
Reconciliation of GAAP to Non-GAAP
General and administrative:
GAAP General and administrative
$
24,841
$
20,704
Less: Stock-based compensation expense
(7,838
)
(7,871
)
Non-GAAP General and administrative
$
17,003
$
12,833
Reconciliation of GAAP to Non-GAAP
Operating expenses:
GAAP Operating expense
$
64,953
$
55,858
Less: Stock-based compensation expense
(15,444
)
(14,679
)
Non-GAAP Operating expense
$
49,509
$
41,179
Reconciliation of GAAP to Non-GAAP Net
loss:
GAAP Net loss
$
(73,842
)
$
(67,455
)
Add: Stock-based compensation expense
15,444
14,679
Add: Non-cash interest expense from
liability related to sale of future royalties
9,871
10,925
Non-GAAP Net loss
$
(48,527
)
$
(41,851
)
Reconciliation of GAAP to Non-GAAP Net
loss per common share-basic and diluted:
GAAP Net loss per common share-basic and
diluted
$
(2.03
)
$
(1.86
)
Add: Stock-based compensation expense
0.42
0.41
Add: Non-cash interest expense from
liability related to sale of future royalties
0.28
0.29
Non-GAAP Net loss per common share-basic
and diluted
$
(1.33
)
$
(1.16
)
Three Months Ended
March 31, 2022
December 31, 2021
September 30, 2021
June 30, 2021
Reconciliation of GAAP to Non-GAAP
Operating expenses
(unaudited)
GAAP Operating expenses
$
64,953
$
72,503
$
65,486
$
62,351
Less: Stock-based compensation expense
(15,444
)
(15,226
)
(13,657
)
(13,244
)
Non - GAAP Operating expenses
$
49,509
$
57,277
$
51,829
$
49,107
Reconciliation of GAAP to Non-GAAP Net
loss
GAAP Net loss
$
(73,842
)
$
(85,385
)
$
(71,846
)
$
(72,700
)
Add: Stock-based compensation expense
15,444
15,226
13,657
13,244
Add: Non-cash interest expense from
liability related to sale of future royalties
9,871
12,376
11,958
11,429
Non-GAAP Net loss
$
(66,866
)
$
(57,783
)
$
(46,231
)
$
(48,027
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220510005602/en/
Reata Pharmaceuticals, Inc. (972) 865-2219
https://www.reatapharma.com/
Investor Relations & Media Relations: John Hunter
ir@reatapharma.com Wendy Segal media@reatapharma.com
https://www.reatapharma.com/contact-us/
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