Full Press Release Details
Tempest Releases New Data Demonstrating Superiority of
TPST-1120 Arm Across Multiple Study Endpoints in
Randomized First-Line HCC Study
Brisbane, CA, October 11, 2023 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, today announced new and updated
positive results from the planned data analysis of an ongoing global randomized Phase 1b/2 clinical study in which TPST-1120, Tempest s PPAR antagonist, shows clinical superiority in multiple study endpoints when combined with
atezolizumab and bevacizumab in a randomized comparison to atezolizumab and bevacizumab in the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma ( HCC ).
This comprehensive analysis of more mature clinical data shows an even greater benefit than the
earlier interim analysis of the TPST-1120 triplet therapy over standard of care alone, both for the entire study population and in subpopulations of patients, the latter of which was predicted by TPST-1120 s proposed mechanism of action,
said Stephen Brady, president and chief executive officer of Tempest. First-line HCC remains an indication with substantial opportunity to improve patient outcomes and, based upon these data, we are excited about the opportunity to move
TPST-1120 into a pivotal study. Given these new data and the Phase 1 evidence of activity beyond HCC, we look forward to advancing discussions with potential partners who share our vision for TPST-1120.
These new data were provided by F. Hoffman La-Roche ( Roche ) from a clinical collaboration pursuant to
which Roche managed the study operations for this multicenter trial. Tempest retains all product rights to TPST-1120. Data from 40 patients randomized to the TPST-1120 arm and 30 patients randomized to the control arm, with a median follow-up of 9.2 and 9.9 months, respectively, show:
Secondary endpoints include DoR, PFS, and OS, which are not fully mature as of the data cut. In Roche s IMbrave150 Phase 3 trial, confirmed ORR benefit
correlated with overall survival (OS) benefit.2
Enrollment began in fall of 2021 and the cutoff date
for these data was April 20, 2023. Tempest expects the data set to be jointly presented by Roche and Tempest at a medical meeting at a later date. ORR was determined by RECIST v1.1, and confirmed responses included at least two scans.
Conference Call & Webcast Information
will host a webcast conference call today, October 11, 2023 at 8:30am ET.
To join the conference call via phone and participate in the live Q&A
session, please pre-register online here to receive a telephone number and unique passcode required to enter the call. The live webcast and audio archive of the presentation may be accessed on the
investor section of the Tempest website at https://ir.tempesttx.com/. The webcast will be available for replay for 30 days.
Randomized Clinical Trial
The Phase 1b/2 global randomized HCC study is part of Roche s Morpheus program and evaluates TPST-1120 in combination
with atezolizumab and bevacizumab versus atezolizumab and bevacizumab, the standard of care, in patients with unresectable or metastatic HCC not previously treated with systemic therapy. The trial enrolled 70 patients to the TPST-1120 arm and
contemporaneous control arm at approximately 25 sites worldwide, including in the United States, Europe, and Asia, who received either the TPST-1120 combination or atezolizumab and bevacizumab with primary efficacy endpoint of objective response
rate, and key secondary endpoints including PFS and OS. Under the terms of the clinical collaboration agreement, Roche is managing the study operations for this global, multicenter trial and Tempest retains all product rights.
TPST-1120 is an oral, small molecule, selective PPAR antagonist wholly-owned by Tempest. Tempest s data suggest that TPST-1120 treats cancer by
targeting tumor cell metabolism directly, as well as by modulating immune suppressive cells and angiogenesis in the tumor microenvironment. In a Phase 1 clinical trial in patients with heavily-pretreated advanced solid tumors, TPST-1120 as
monotherapy and in combination with the PD-1 inhibitor nivolumab demonstrated tumor reduction (including according to RECIST criteria), as well as biomarker modulation. TPST-1120 was well-tolerated both as a
monotherapy and in combination with nivolumab.
About Hepatocellular Carcinoma
HCC is an aggressive cancer with rising mortality and is projected to become the third leading cause of cancer death by 2030.3 Every year, more than 900,000 people worldwide are diagnosed with HCC.4 Incidence and mortality are highest in East Asia and are
increasing in parts of Europe and the US.5 In the US, HCC represents the fastest-rising cause of cancer-related death.3
Nine out of ten cases of HCC are caused by chronic liver disease, which includes chronic hepatitis B and C infection,
non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), alcohol-related liver disease (ALD) and cirrhosis resulting from these conditions.6
Even if diagnosed in the early stage, an estimated 70-80% of
people with early-stage HCC experience disease recurrence following surgery.7 Early recurrence is associated with poorer prognosis and shorter survival.5,8 Tumor size, number of tumors, and portal vein invasion are associated with an increased risk of recurrence.6
About Tempest Therapeutics
Tempest Therapeutics is a clinical-stage oncology company advancing small molecules that combine both tumor-targeted and immune-mediated mechanisms with the
potential to treat a wide range of tumors. The company has a diverse portfolio of novel programs ranging from early research to investigation in a randomized global study in first-line cancer patients. The company s two novel clinical programs,
TPST-1120 and TPST-1495, target PPAR and EP2/EP4, respectively, and are advancing through trials designed to study the agents as monotherapies and in combination with approved agents. Tempest is also developing an orally available inhibitor of
TREX1, a target that controls activation of the cGAS/STING pathway. Tempest is headquartered in Brisbane, California. More information about Tempest can be found on the company s website at www.tempesttx.com.
Forward-Looking Statements
This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended,
and Section 27A of the Securities Act of 1933, as amended (the Securities Act ) concerning Tempest Therapeutics, Inc. ( Tempest Therapeutics ). These statements may discuss goals, intentions, and expectations as to future
plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Tempest Therapeutics, as well as assumptions made by, and information currently available to, management of Tempest
Therapeutics. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as may, will, should,
would, could , expect, anticipate, plan, likely, believe, estimate, project, intend, and other similar expressions. All statements
that are not historical facts are forward-looking statements, including any statements regarding the availability of data from clinical trials, the favorable results of clinical trials, the ability of the company or its collaborators to present such
data at certain conferences, and the ability of the company to advance discussions with potential partners to explore the development of TPST-1120. Forward-looking statements are based on information available to Tempest Therapeutics as of the date
hereof and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement. These and other risks are described in greater detail in the Form
10-Q filed by Tempest Therapeutics with the Securities and Exchange Commission on August 10, 2023. Except as required by applicable law, Tempest Therapeutics undertakes no obligation to revise or
update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Tempest
Therapeutics views as of any date subsequent to the date of this press release and should not be relied upon as prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in
reaching any conclusion or making any investment decision about any securities of Tempest Therapeutics.
Wheelhouse Life Science Advisors
Wheelhouse Life Science Advisors