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 first quarter ended
March 31, 2020.
Sujal Shah, President and CEO of CymaBay, stated, “Last week a
panel of some of the most experienced and distinguished liver
pathologists and hepatologists in the world completed an
independent review analyzing findings from our Phase 2b study of
seladelpar in patients with NASH. I am pleased to report that the
panel unanimously concluded there was no clinical, biochemical or
histological evidence of seladelpar-induced liver injury in the
study, and as a result they also unanimously supported the lifting
of the clinical hold and re-initiation of clinical
development.
While we have not yet discussed full results from our
investigation nor any of the panel’s conclusions with the FDA, we
are planning to re-engage with the agency as quickly as possible.
At this point we cannot guarantee what the next steps or timelines
will be, but we are confident that we have conducted a truly
rigorous, independent review to help us definitively support the
conclusion that seladelpar did not cause drug-induced liver injury
in our NASH phase 2b study.”
Dr. Paul Watkins, Howard Q Ferguson Distinguished Professor,
Schools of Medicine, Pharmacy, and Public Health, Director,
Institute for Drug Safety Sciences at the University of North
Carolina, Chapel Hill, said, “I was pleased to chair this esteemed
independent panel of liver experts. The panel conducted a
comprehensive, systematic review and discussion of all of the
clinicopathological data from the seladelpar NASH Phase 2b study.
In my experience, no other drug in development for NASH has been
through such rigorous scrutiny of safety data at this stage of
development. As we have stated, the features noted by study
pathologists at end of treatment were confirmed on this review.
However, these did not differ qualitatively between baseline and
end of treatment. We suspect these histologic features are
underreported; however, in the experience of the pathology review
subcommittee, these features may be observed in patients with NASH.
The panel unanimously concluded that the data in aggregate,
including the lack of significant differences in histologic
features or their changes across the placebo and treatment groups,
do not support injury related to seladelpar.”
Dr. Stephen Harrison, Medical Director, Pinnacle Clinical
Research, Visiting Professor of Hepatology at Radcliffe Department
of Medicine, University of Oxford, and principal investigator of
the seladelpar Phase 2b study in NASH, added, “I believe CymaBay
and the FDA did the right thing in putting patient safety first
when development of seladelpar was halted at the end of last year
until an in-depth investigation was conducted into the findings
identified by study pathologists in the NASH study. At this point,
the findings and additional data collected have been thoroughly
investigated by leading experts in the areas of drug-induced liver
injury and hepatopathology. Given the benefit observed on both NASH
resolution and fibrosis with seladelpar in the NASH Phase 2b study
as well as data presented at multiple medical meetings from studies
of seladelpar in PBC, I am pleased that the independent review
panel is supportive of restarting clinical development pending
approval from the FDA.”
Recent Corporate Highlights
- At the end of last week, a panel of eight of the world’s
foremost expert liver pathologists and hepatologists, whose
collective experience relevant to CymaBay’s investigation includes
drug-induced liver injury, NASH and cholestatic liver diseases,
completed a four-day independent review analyzing findings from
CymaBay’s NASH Phase 2b study. The panel unanimously supported
lifting the clinical hold for seladelpar and re-initiation of
clinical development. In addition to the chair, Dr. Paul Watkins,
the panel included:° Pierre Bedossa, MD, PhD, Professor of
Pathology at the University Paris-Diderot, France, and Medical
Director and CEO of LIVERPAT° Michael Charlton, MD, Chief of
Hepatology, Director of the Center for Liver Diseases and Medical
Director of the Transplant Institute at the University of Chicago°
Zachary Goodman, MD, PhD, Director of Hepatic Pathology
Consultation and Research, Center for Liver Disease, Inova
Healthcare Services° Neil Kaplowitz, MD, Professor of Medicine and
Thomas H. Brem Chair in Medicine, Budnick Chair of Liver Disease,
Keck School of Medicine, University of Southern California° David
Kleiner, MD, PhD, Head of Histopathology and Autopsy Pathology at
the NIH and the Reference Pathologist for the Drug-Induced Liver
Injury Network° Willis Maddrey, MD, Professor Emeritus of Internal
Medicine at The University of Texas Southwestern Medical Center°
John Vierling, MD, Professor of Medicine and Surgery, Baylor
College of Medicine
- CymaBay intends to reach out to the FDA to discuss all of the
data it has collected to date and the results of the panel review
meetings. Once initial feedback is gathered, CymaBay intends to
submit a complete response to the seladelpar clinical hold to the
FDA. The CymaBay Board of Directors has worked closely with
management throughout the investigation and panel review and is in
support of next steps to re-engage with the FDA.
- As a reminder, during the fourth quarter of 2019, management
implemented a restructuring program following the placement of the
seladelpar program on clinical hold pending further investigation
of the histologic observations noted by study pathologists in
CymaBay’s Phase 2b NASH study and pending completion of its review
of strategic options.
- Late in the first quarter of 2020, the need for sustained cost
containment was further underscored by the unexpected and rapid
onset of the coronavirus pandemic and the associated travel
restrictions and shelter-in-place orders issued by governmental
authorities in jurisdictions where CymaBay, its partners,
investigators, and vendors, conduct operations. In response
to these measures, CymaBay has taken steps, such as enabling remote
operations for all employees, which have allowed operating
activities to continue as seamlessly as possible.
- CymaBay will continue to closely monitor pandemic developments
and their associated risks to the business, and will take actions
available to mitigate them where possible. Further, all of
CymaBay’s actions will be guided by a commitment to taking all
steps possible to ensure the health and safety of its
employees.
- Held $176.2 million in cash, cash equivalents and short-term
investments at March 31, 2020.
Mr. Shah continued, “As the next steps in our seladelpar
investigation process become clear we will continue to keep our
shareholders updated as appropriate, while also continuing to
evaluate potential strategic alternatives. Further, we remain
focused on cost containment and will look at additional steps we
can take into fiscal year 2020 in order to closely control the
Company’s operating expenses and associated cash burn.”
First Quarter Ended March 31, 2020 Financial
Results
- Research and development expenses for the three months ended
March 31, 2020 were $9.5 million, compared to $18.6 million for the
three months ended March 31, 2019. Research and development
expense in the first quarter of 2020 was significantly lower than
the corresponding period in 2019 primarily due to declining
clinical trial activities related to the Phase 3 PBC, Phase 2b
NASH, and Phase 2 PSC clinical trials, and other studies, as
efforts continue to scale back and shut down these studies as a
result of the clinical hold on the seladelpar development
program.
- General and administrative expenses for the three months ended
March 31, 2020 were $4.3 million, compared to $5.7 million for the
three months ended March 31, 2019. General and administrative
expenses in the first quarter of 2020 was lower than the
corresponding period in 2019 due to lower continuing labor costs
and other administrative expenses following restructuring efforts
undertaken in the fourth quarter of 2019.
- Net loss for the three months ended March 31, 2020 was $13.1
million, or ($0.19) per diluted share, compared to a net loss of
$23.1 million, or ($0.37) per diluted share in the three months
ended March 31, 2019. Net loss was lower in the first quarter of
2020 compared to the corresponding period in 2019 primarily due to
a decrease in operating expenses, including clinical trial and
labor related expenses.
Conference Call Details
CymaBay will host a conference call today at
4:30 p.m. ET to discuss first quarter 2020 financial results and
provide a corporate 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# 10009543. 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 seladelpar histological
findings, the potential benefits of seladelpar to patients with
NASH, CymaBay’s expectations and plans regarding its intended
future interactions with the FDA, its 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 seladelpar histological findings have not yet been
submitted to the FDA, and there is no guarantee as to how or when
the FDA will respond; 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.
Important InformationCymaBay
Therapeutics, Inc. filed a preliminary proxy statement with the
Securities and Exchange Commission (the “SEC”) on May 5, 2020, and
intends to file a definitive proxy statement and associated WHITE
proxy card with the SEC in connection with the solicitation of
proxies for CymaBay’s 2020 Annual Meeting of Stockholders (the
“2020 Annual Meeting”). Any definitive proxy statement and WHITE
proxy card will be mailed to CymaBay’s stockholders. BEFORE
MAKING ANY VOTING DECISION, INVESTORS AND STOCKHOLDERS OF CYMABAY
ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH OR FURNISHED TO
THE SEC, INCLUDING CYMABAY’S PROXY STATEMENT AND ANY SUPPLEMENTS
THERETO, IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL
CONTAIN IMPORTANT INFORMATION. Investors and stockholders can
obtain a copy of the relevant documents filed by CymaBay with the
SEC, including the definitive proxy statement, when it becomes
available, free of charge by visiting the SEC’s
website, www.sec.gov. Investors and stockholders can also
obtain, without charge, a copy of the definitive proxy statement,
when available, and other relevant filed documents
at https://ir.cymabay.com/all-sec-filings.
Participants in the
SolicitationCymaBay, its directors and certain of its
executive officers will be deemed participants in the solicitation
of proxies from stockholders in respect of the 2020 Annual Meeting.
Information regarding the names of CymaBay’s directors and
executive officers and their respective interests in CymaBay by
security holdings or otherwise is set forth in CymaBay’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2019,
filed with the SEC on March 16, 2020, Amendment No.1 to CymaBay’s
Annual Report on Form 10-K for the fiscal year ended December 31,
2019, filed with the SEC on April 29, 2020 and CymaBay’s
preliminary proxy statement for the 2020 Annual Meeting of
Stockholders, filed with the SEC on May 5, 2020. All such
information will be contained in the definitive proxy statement and
related materials that CymaBay will mail to CymaBay’s stockholders
in connection with the 2020 Annual Meeting of Stockholders.
These documents can be obtained free of charge from the sources
indicated above.
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 |
|
March 31, |
|
2020 |
|
2019 |
|
(unaudited) |
|
(unaudited) |
|
|
|
|
Operating expenses: |
|
|
|
Research and development |
$ |
9,509 |
|
$ |
18,588 |
General and administrative |
4,347 |
|
5,663 |
Restructuring charges |
71 |
|
- |
Total operating expenses |
13,927 |
|
24,251 |
|
|
|
|
Loss from operations |
(13,927) |
|
(24,251) |
Other income (expense): |
|
|
|
Interest income |
839 |
|
1,176 |
Total other income (expense) |
839 |
|
1,176 |
Net loss |
$ |
(13,088) |
|
$ |
(23,075) |
|
|
|
|
Basic net loss per common share |
$ |
(0.19) |
|
$ |
(0.37) |
Diluted net loss per common share |
$ |
(0.19) |
|
$ |
(0.37) |
|
|
|
|
Weighted average common shares |
|
|
|
outstanding used to calculate |
|
|
|
basic net loss per common share |
68,882,459 |
|
61,890,632 |
Weighted average common shares |
|
|
|
outstanding used to calculate |
|
|
|
diluted net loss per common share |
68,882,459 |
|
61,890,632 |
|
|
|
|
|
CymaBay Therapeutics, Inc. |
Balance Sheet Data |
(In thousands) |
|
|
|
|
|
March 31, |
|
December 31, |
|
2020 |
|
2019 |
|
|
|
|
Cash, cash equivalents and
marketable securities |
$ |
176,232 |
|
$ |
190,945 |
Working capital |
174,027 |
|
185,287 |
Total assets |
188,600 |
|
205,727 |
Total liabilities |
13,552 |
|
19,379 |
Common stock and additional
paid-in capital |
814,138 |
|
812,140 |
Total stockholders’ equity |
175,048 |
|
186,348 |
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