CymaBay Reports Fourth Quarter and Fiscal Year End 2019 Financial Results and Provides Corporate Update
March 12 2020 - 4:01PM
CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage
biopharmaceutical company focused on developing therapies for liver
and other chronic diseases with high unmet need, today announced
corporate updates and financial results for the fourth quarter and
fiscal year ended December 31, 2019.
“Since announcing the decision to halt the development of
seladelpar last November, we have been focused on two parallel
initiatives: an investigation of the unexpected histologic findings
identified by study pathologists in the Phase 2b study of
seladelpar in NASH, and an evaluation of strategic alternatives to
maximize shareholder value,” said Sujal Shah, President and CEO of
CymaBay. “Our investigation includes several key activities that
will be essential for us to understand the nature and significance
of the findings and have the requisite follow-up dialogue with the
FDA which we are planning for before the end of the second
quarter.”
Shah continued, “In parallel to this investigation, our
executive team and board have been focused on a comprehensive
evaluation of strategic alternatives and cost-cutting initiatives.
While we remain committed to completing the investigation, we
believe these efforts are prudent in order to make decisions
expeditiously once we gain needed clarity on the potential path
forward for seladelpar.”
Recent Business Highlights
- The development of seladelpar was halted in all indications
after consulting with expert liver pathologists and hepatologists
and in consideration of patient safety. The FDA agreed with this
decision, formally placed the seladelpar program on clinical hold
for all indications, and subsequently provided input on plans to
further investigate the situation. Since then, CymaBay has
commenced an in-depth review of the Phase 2b NASH findings. This
investigation includes three activities intended to confirm and
subsequently understand the significance of the findings identified
by study pathologists:
- First, a comprehensive collection and review of data including
patient demographics, medical history, concomitant medications and
a broad set of biochemical markers.
- Second, a blinded, independent review of baseline and end of
treatment biopsies by several, world-renowned liver pathologists.
The independent pathology review will include an accepted pathology
scoring framework, known as the Ishak Modified HAI scoring system,
to quantitatively characterize features of histology present in our
patient population both at baseline and at end-of-treatment. Among
these features includes a scoring for the presence and severity of
interface hepatitis which is not quantified in the existing
framework for scoring NASH pathology.
- Third, a formal pathology and clinical hepatology review panel
meeting that CymaBay anticipates convening in the middle of the
second quarter during which experts will review all information
gathered to provide a consensus and independent determination of
the role of seladelpar in the Phase 2b NASH findings. This panel
will allow for a properly informed dialogue with FDA regarding
seladelpar development.
- Completed reading of the Phase 2b NASH end-of-treatment
biopsies by study pathologists. Preliminary results reported below
are for the 152 patients out of the 181 patients enrolled in the
study with paired biopsies at entry and end-of-study:
Phase 2b Preliminary Topline Results
Proportion of Patients Achieving Endpoints at End of Study
|
Placebo (N = 25) |
Seladelpar 10 mg (N = 39) |
Seladelpar 20 mg (N = 42) |
Seladelpar 50 mg (N = 46) |
Fibrosis improvement (≥1 stage) with no worsening of NASH |
20.0 |
% |
23.1 |
% |
23.8 |
% |
37.0 |
% |
Resolution of NASH with no worsening of fibrosis |
8.0 |
% |
10.3 |
% |
19.0 |
% |
26.1 |
% |
Fibrosis improvement and resolution of NASH |
8.0 |
% |
5.1 |
% |
11.9 |
% |
19.6 |
% |
* Statistics pending
final analysis. |
|
- Resolution of NASH defined as patients having a NAFLD Activity
Score (NAS) of 0 or 1 for lobular inflammation and 0 for
hepatocellular ballooning.
- Patients that did not have end-of-study biopsies are not
included in reported histology endpoints.
- Measured changes from baseline to end-of-treatment in liver
enzymes including ALT, AST, GGT and ALP, resembled the pattern of
meaningful reductions previously reported at week 12.
|
- Implemented cost containment and restructuring program
following the decision to place the seladelpar program on hold in
order to minimize expenses and conserve capital. As part of this
program, CymaBay froze hiring, significantly scaled-back future
procurement plans, reduced its work force by more than 60% and
scaled down or cancelled many existing contracts for goods and
services. The size of the Board of Directors has also been
decreased from nine to five seats.
- As a result of these actions, CymaBay recorded a $5.1 million
restructuring charge during the fourth quarter which includes $2.9
million of employee severance costs, $0.9 million of non-cash
stock-based compensation expense associated with the acceleration
of stock options of certain terminated employees, and $1.3 million
of charges associated with the termination of certain contract
manufacturing agreements.
- Held $190.9 million in cash, cash equivalents and short-term
investments at December 31, 2019.
Fourth Quarter and Year Ended December 31, 2019
Financial Results
- Research and development expenses for the three and twelve
months ended December 31, 2019 were $20.9 million and $83.8
million, respectively. This compared to R&D expenses of $16.4
million and $58.1 million for the three and twelve months ended
December 31, 2018, respectively. Prior to the decision to halt
development of seladelpar in November 2019, research and
development expenses in the fourth quarter and twelve months ended
2019 were generally higher than in the corresponding periods in
2018 due to expanding clinical trial activities related to the PBC
Phase 3 clinical trial, PSC Phase 2 clinical trial, and other
NDA-enabling studies.
- General and administrative expenses for the three and twelve
months ended December 31, 2019 were $4.5 million and $19.2 million,
respectively. This compared to $4.2 million and $14.4 million
for the three and twelve months ended December 31, 2018,
respectively. Prior to the decision to halt development of
seladelpar, G&A expenses in the fourth quarter and twelve
months ended 2019 were higher than in the corresponding periods in
2018 as a result of higher labor costs and other administrative
expenses necessary to support expanding development
activities.
- Net loss for the three and twelve months ended December 31,
2019 was $29.4 million, or ($0.43) per diluted share, and $102.8
million, or ($1.53) per diluted share, respectively. This
compared to net loss of $19.4 million, or ($0.32) per diluted
share, and $72.5 million, or ($1.26) per diluted share, in the
three and twelve months ended December 31, 2018, respectively. Net
loss was higher largely due to increases in operating expenses,
including restructuring charges.
Conference Call Details
CymaBay will host a conference call today at 4:30 p.m. ET to
discuss fourth quarter and fiscal year end 2019 financial results
and provide a business update. To access the live conference
call, please dial 855-327-6837 from the U.S. and Canada, or
631-891-4304 internationally, Conference ID# 10008868. To access
the live and subsequently archived webcast of the conference call,
go to the Investors section of the company's website at
http://ir.cymabay.com/events.
About CymaBay CymaBay
Therapeutics, Inc. is a clinical-stage biopharmaceutical company
focused on developing therapies for liver and other chronic
diseases with high unmet medical need.
Cautionary Statements The
statements in this press release regarding the timing of completion
and outcome of the investigation into the seladepar histological
findings, the potential benefits of seladelpar to patients with
NASH, CymaBay’s expectations and plans regarding current and future
clinical trials and CymaBay’s ability to fund current and planned
clinical trials are forward looking statements that are subject to
risks and uncertainties. Actual results and the timing of events
regarding the further development of seladelpar could differ
materially from those anticipated in such forward-looking
statements as a result of risks and uncertainties, which include,
without limitation, risks related to: the success, cost and timing
of any of CymaBay's product development activities, including
clinical trials; effects observed in trials to date that may not be
repeated in the future; any delays or inability to obtain or
maintain regulatory approval of CymaBay's product candidates in the
United States or worldwide; and the ability of CymaBay to obtain
sufficient financing to complete development, regulatory approval
and commercialization of its product candidates in the United
States and worldwide or to potentially restart clinical trials.
Additional risks relating to CymaBay are contained in CymaBay's
filings with the Securities and Exchange Commission, including
without limitation its most recent Annual Report on Form 10-K and
other documents subsequently filed with or furnished to the
Securities and Exchange Commission. CymaBay disclaims any
obligation to update these forward-looking statements except as
required by law.
For additional information about CymaBay visit
www.cymabay.com.
Contact:
Sloane & CompanyDan Zacchei / Joe Germani,
212-486-9500Dzacchei@sloanepr.com / JGermani@sloanepr.com
CymaBay
Therapeutics, Inc. |
Financial
Results |
(In thousands,
except share and per share information) |
|
|
|
|
|
|
|
|
|
|
|
Quarter
Ended |
|
Year
Ended |
|
|
December 31, |
|
December 31, |
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
|
(unaudited) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
20,937 |
|
|
$ |
16,397 |
|
|
$ |
83,837 |
|
|
$ |
58,124 |
|
General and administrative |
|
|
4,532 |
|
|
|
4,158 |
|
|
|
19,238 |
|
|
|
14,381 |
|
Charges on restructuring |
|
|
5,075 |
|
|
|
- |
|
|
|
5,075 |
|
|
|
- |
|
Total operating expenses |
|
|
30,544 |
|
|
|
20,555 |
|
|
|
108,150 |
|
|
|
72,505 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(30,544 |
) |
|
|
(20,555 |
) |
|
|
(108,150 |
) |
|
|
(72,505 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest income |
|
|
1,131 |
|
|
|
1,106 |
|
|
|
5,342 |
|
|
|
3,988 |
|
Interest expense |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(336 |
) |
Loss on extinguishment of debt |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(407 |
) |
Other expense, net |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(3,288 |
) |
Total other income (expense) |
|
|
1,131 |
|
|
|
1,106 |
|
|
|
5,342 |
|
|
|
(43 |
) |
Net loss |
|
$ |
(29,413 |
) |
|
$ |
(19,449 |
) |
|
$ |
(102,808 |
) |
|
$ |
(72,548 |
) |
|
|
|
|
|
|
|
|
|
Basic net loss per common share |
|
$ |
(0.43 |
) |
|
$ |
(0.32 |
) |
|
$ |
(1.53 |
) |
|
$ |
(1.25 |
) |
Diluted net loss per common share |
|
$ |
(0.43 |
) |
|
$ |
(0.32 |
) |
|
$ |
(1.53 |
) |
|
$ |
(1.26 |
) |
|
|
|
|
|
|
|
|
|
Weighted average common shares |
|
|
|
|
|
|
|
|
outstanding used to calculate |
|
|
|
|
|
|
|
|
basic net loss per common share |
|
|
68,749,075 |
|
|
|
59,448,000 |
|
|
|
67,033,046 |
|
|
|
57,808,254 |
|
Weighted average common shares |
|
|
|
|
|
|
|
|
outstanding used to calculate |
|
|
|
|
|
|
|
|
diluted net loss per common share |
|
68,749,075 |
|
|
|
59,448,000 |
|
|
|
67,033,046 |
|
|
|
57,838,299 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CymaBay
Therapeutics, Inc. |
Balance
Sheet Data |
(In thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31, |
|
December
31, |
|
|
|
|
|
|
2019 |
|
2018 |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
|
|
$ |
190,945 |
|
|
$ |
178,664 |
|
Working capital |
|
|
|
|
185,287 |
|
|
|
167,147 |
|
Total assets |
|
|
|
|
205,727 |
|
|
|
186,747 |
|
Total liabilities |
|
|
|
|
19,379 |
|
|
|
16,329 |
|
Common stock and additional paid-in capital |
|
|
|
|
812,140 |
|
|
|
693,540 |
|
Total stockholders’ equity |
|
|
|
|
186,348 |
|
|
|
170,418 |
|
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