Tempest Reports Year End 2023 Financial Results and Provides Business Update
-- Announced positive randomized first-line HCC data showing superiority of
TPST-1120 combination therapy across multiple study endpoints compared to
standard of care
-- Reported new biomarker data in two important subpopulations, PD-L1
negative and b-catenin mutant patients, consistent with MoA of TPST-1120
-- Preparing to move TPST-1120 into a pivotal Phase 3 trial in HCC and
TPST-1495 into a Phase 2 in FAP
BRISBANE, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-class(i) targeted and immune-mediated therapeutics to fight cancer, today reported financial results for the year ended 2023 and provided a corporate update.
"2023 was a transformative year for Tempest. We announced strong positive randomized data showing the benefit of TPST-1120 combination therapy compared to standard-of-care in first-line liver cancer," said Stephen Brady, president and chief executive officer of Tempest. "These data also showed the predicted positive effect of TPST-1120 in two subpopulations that are common in liver cancer, i.e., patients with PD-L1 negative and cold tumors, as well as patients with a b-catenin mutation, and we believe set up the program for a pivotal Phase 3 trial. We look forward to 2024 as the year Tempest evolves towards becoming a late-stage clinical organization."
2023 Accomplishments
-- TPST-1120 (clinical PPAR<ALPHA> antagonist):
-- Reported positive interim data in April 2023 from the ongoing
randomized Phase 1b/2 clinical study evaluating TPST-1120 in
combination with the standard-of-care regimen of atezolizumab and
bevacizumab in previously untreated patients with advanced
unresectable or metastatic hepatocellular carcinoma ("HCC"),
compared to patients treated with the standard of care regimen
alone. The data demonstrated clinically meaningful improvement in
multiple categories and signaled the potential superiority of the
TPST-1120 arm in the primary analysis planned for later in the
year.
-- Reported updated positive data from the ongoing randomized study
in October 2023 demonstrating clinical superiority of TPST-1120,
when combined with atezolizumab and bevacizumab, as compared to
the standard-of-care regimen, across multiple study endpoints in
first-line HCC. 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, showed:
-- Confirmed objective response rate ("cORR" or "confirmed
ORR") of 30% for the TPST-1120 triplet arm (an increase
from 17% in the earlier interim analysis), as compared to
13.3% for the atezolizumab + bevacizumab control arm;
duration of response ("DoR") not yet reached.
-- Hazard ratio favors the TPST-1120 arm for key survival
endpoints
-- Progression free survival ("PFS"): median PFS of 7
mo (5.6 mo, 13.8 mo) for TPST-1120 arm versus 4.27
mo (2.8 mo, 7.3 mo) for the control arm; HR of 0.7
favors TPST-1120 arm and is not yet mature
-- Overall survival ("OS"): median OS not reached for
the TPST-1120 arm (10.84 mo, NE) versus 15.1 mo
(7.49 mo, NE) for the control arm; HR 0.59 favors
TPST-1120 arm and is not yet mature
-- 40% of the patients in the TPST-1120 arm were on treatment
(16/40) compared to 16.7% in the atezolizumab + bevacizumab
control arm (5/30)
-- 72.5% of the patients on the TPST-1120 arm were on study
(29/40), compared to 46.7% on the atezolizumab +
bevacizumab control arm (14/30)
-- TPST-1120 remains well tolerated, with safety data
comparable between the two arms
-- Presented new translational biomarker findings at the 2023 American
Association for Cancer Research (AACR) Annual Meeting from the completed
monotherapy and nivolumab combination therapy dose escalation Phase 1
trial in patients with advanced solid tumors, which showed on-target
changes in gene signatures in the peripheral blood that were dependent
upon drug exposure levels. In addition, distinct on-target changes in
both lipid profile and NF-<KAPPA>B pathway regulated immune response gene
signatures were observed in patients who achieved a RECIST response,
compared with non-responders, following treatment with TPST-1120 and
nivolumab.
-- Presented data at the Society for Immunotherapy of Cancer $(SITC)$ 2023
Spring Scientific Meeting highlighting biomarker data from the Phase 1
trial showing an association between observed clinical benefit of
TPST-1120 and fatty acid oxidation perturbations and gene expression.
-- TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist)
-- Presented Phase 1 clinical trial data at the 2023 American Society
of Clinical Oncology (ASCO) Annual Meeting showing that in a
diverse and treatment-refractory patient population, treatment
with TPST-1495 as a monotherapy and in combination with
pembrolizumab resulted in tumor shrinkage and prolonged stable
disease in certain patients, as well as a durable confirmed
partial response in a combination therapy patient with
microsatellite stable colorectal cancer, an indication not
normally responsive to immunotherapy.
-- Announced publication in Cancer Research Communications of data
highlighting the increased potency of TPST-1495 against
prostaglandin-driven tumor models by blocking EP2 and EP4
together.
-- Continued enrollment of an endometrial cancer-specific arm
investigating the two highest doses of TPST-1495 in combination
with pembrolizumab.
Potential Future Milestones
-- TPST-1120 (clinical PPAR<ALPHA> antagonist)
-- Expect to announce updated data from the ongoing randomized study
in first-line liver cancer patients in 2024.
-- Plan to advance TPST-1120 into a registrational study in
first-line liver cancer patients, subject to obtaining feedback
from the FDA.
-- TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist)
-- Plan to advance TPST-1495 into a Phase 2 study in patients with
Familial Adenomatous Polyposis ("FAP") under the auspices of the
Cancer Prevention Clinical Trials Network and funded by the
National Cancer Institute ("NCI") Division of Cancer Prevention in
2024, subject to final approval of NCI.
-- Expect to report data from the combination arm at the two highest
TPST-1495 doses in patients with advanced endometrial cancer in
2024.
Financial Results
Year End 2023
-- Tempest ended the year with $39.2 million in cash and cash equivalents,
compared to $31.2 million on December 31, 2022. The increase was
primarily due to proceeds from the issuance of common stock of $35.6
million from the at-the-market offering program, offset by cash used in
operating activities.
-- Net loss and net loss per share for the year were $29.5 million and
$1.91, respectively, compared to $35.7 million and $3.09, respectively,
for the same period in 2022.
-- Research and development expenses for the year were $17.5 million
compared to $22.5 million for the same period in 2022. The $5.0 million
decrease was primarily due to a decrease in costs incurred from contract
research organizations and third-party vendors.
-- General and administrative expenses for the year were $11.7 million
compared to $12.1 million for the same period in 2022. The $0.4 million
decrease was primarily due to a decrease in consulting and professional
services.
-- Based on current cash and operating plan, Tempest expected to have
sufficient resources to fund operations into the second quarter of 2025.
About Tempest Therapeutics
Tempest Therapeutics is a clinical-stage biotechnology company advancing a diverse portfolio of small molecule product candidates containing tumor-targeted and/or immune-mediated mechanisms with the potential to treat a wide range of tumors. The company's novel programs range from early research to later-stage investigation in a randomized global study in first-line cancer patients. 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
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