Tempest Reports First Quarter 2024 Financial Results and Provides Business Update
09 Maio 2024 - 5:29PM
Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage
biotechnology company developing first-in-classi targeted and
immune-mediated therapeutics to fight cancer, today reported
financial results for the quarter ended March 31, 2024, and
provided a corporate update.
"The positive data and mechanistic analysis
presented in the first quarter build on the positive preclinical
and clinical data package for TPST-1120, further confirming and
reinforcing our excitement about the potential of TPST-1120 in
liver and kidney cancers, as well as other indications, and our
confidence in the program as it moves closer to a pivotal Phase 3
study in first-line HCC,” said Stephen Brady, president and chief
executive officer of Tempest.
Recent Highlights
-
TPST-1120 (clinical PPARα antagonist):
- Reported new
preclinical data at the 2024 American Association for Cancer
Research (AACR) Annual Meeting demonstrating that TPST-1120 reduces
kidney cancer (RCC) growth as a monotherapy, while also showing
increased inhibition when combined with frontline chemotherapy and
immunotherapy. These data further support the clinical benefit
observed in the TPST-1120 Phase 1 data presented in an oral
presentation at ASCO 2022.
- Published
positive data from Phase 1 Trial of TPST-1120 in patients with
advanced solid tumors in the Journal of Cancer Research
Communications. Data showed that TPST-1120 demonstrated clinical
activity, including tumor shrinkage, even in PD-1
inhibitor-refractory and immune-compromised cancers, and was well
tolerated both as monotherapy and in combination with nivolumab.
These data complement the positive Phase 1b/2 data reported in
October 2023 from a global randomized study of TPST-1120 in
combination with atezolizumab and bevacizumab in first-line
patients with advanced HCC.
- Presented new
preclinical data showing potent anti-tumor activity in several
cancer models treated with TPST-1120 alone or with immune
checkpoint inhibitors at the Society for Immunotherapy of Cancer
(SITC) 2024 Spring Scientific Meeting. The presentation also
covered experimental results that corroborated clinical biomarker
data from patients with advanced solid tumor cancers treated in the
Phase 1 clinical trial of TPST-1120 in multiple solid tumor
indications, which showed statistically significant,
exposure-dependent elevations in expression levels of multiple
immune-related genes, and patients exhibiting objective responses
displayed increased circulating free fatty acids (FFA), both of
which are in-line with the proposed TPST-1120 mechanism of
action.
Potential Future Milestones
-
TPST-1120 (clinical PPARα antagonist)
- Expect to
announce updated data from the ongoing randomized study in
first-line HCC patients in 2024.
- Plan to advance
TPST-1120 into a registrational Phase 3 study in first-line HCC
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”) in 2024 under the auspices of the
Cancer Prevention Clinical Trials Network and funded by the
National Cancer Institute (“NCI”) Division of Cancer Prevention,
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, where prostaglandin
signaling is implicated, in 2024.
Financial Results
First Quarter 2024
- Tempest ended
the quarter with $32.3 million in cash and cash equivalents,
compared to $39.2 million on December 31, 2023.
- Net loss and net
loss per share for the quarter ended March 31, 2024, were $7.9
million and $0.36, respectively, compared to $7.6 million and
$0.55, respectively, for the same period in 2023.
- Research and
development expenses for the quarter were $4.3 million compared to
$4.7 million for the same period in 2023. The $0.4 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 quarter were $3.6 million compared
to $2.9 million for the same period in 2023. The $0.7 million
increase was primarily due to share-based compensation expenses and
consulting services.
- Based on its
current cash and operating plan, Tempest expects 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
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. 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 design, initiation, progress, timing,
scope and results of clinical trials; anticipated therapeutic
benefit and regulatory development of the Company’s product
candidates; the Company’s anticipated cash runway; the Company’s
ability to deliver on potential value-creating milestones; the
Company’s ability to advance into a late-stage clinical company;
and the Company’s ability to achieve its operational plans.
Forward-looking statements are based on information available to
Tempest Therapeutics as of the date hereof and are not guarantees
of future performance. Any factors may cause differences between
current expectations and actual results, including: unexpected
safety or efficacy data observed during preclinical or clinical
trials; clinical trial site activation or enrollment rates that are
lower than expected; changes in expected or existing competition;
changes in the regulatory environment; and unexpected litigation or
other disputes. Other factors that may cause actual results to
differ from those expressed or implied are discussed in greater
detail in the “Risk Factors” section of the Company’s Quarterly
Report on Form 10-Q for the quarter ended March 31, 2024 and other
documents filed by the Company from time to time with the
Securities and Exchange Commission. 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.
TEMPEST THERAPEUTICS, INC. |
|
Consolidated Balance Sheets |
|
(in thousands) |
|
|
|
|
|
|
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
32,326 |
|
|
$ |
39,230 |
|
Prepaid expenses and other current assets |
|
1,171 |
|
|
|
1,133 |
|
Total current assets |
|
33,497 |
|
|
|
40,363 |
|
|
|
|
|
|
|
Property and equipment,
net |
|
920 |
|
|
|
840 |
|
Operating lease right-of-use
assets |
|
9,513 |
|
|
|
9,952 |
|
Other noncurrent assets |
|
448 |
|
|
|
448 |
|
|
|
|
|
|
|
Total assets |
$ |
44,378 |
|
|
$ |
51,603 |
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts payable |
$ |
1,051 |
|
|
$ |
845 |
|
Accrued expenses |
|
1,524 |
|
|
|
1,673 |
|
Current loan payable, net |
|
6,458 |
|
|
|
4,285 |
|
Current operating lease liabilities |
|
858 |
|
|
|
952 |
|
Accrued compensation |
|
690 |
|
|
|
1,543 |
|
Interest payable |
|
110 |
|
|
|
113 |
|
Total current liabilities |
|
10,691 |
|
|
|
9,411 |
|
|
|
|
|
|
|
Loan payable, net |
|
4,140 |
|
|
|
6,264 |
|
Operating lease
liabilities |
|
8,915 |
|
|
|
9,160 |
|
Total liabilities |
|
23,746 |
|
|
|
24,835 |
|
|
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
Common stock |
|
22 |
|
|
|
22 |
|
Additional paid-in capital |
|
193,777 |
|
|
|
192,009 |
|
Accumulated deficit |
|
(173,167 |
) |
|
|
(165,263 |
) |
Total stockholders' equity |
|
20,632 |
|
|
|
26,768 |
|
Total liabilities and stockholders' equity |
$ |
44,378 |
|
|
$ |
51,603 |
|
|
|
|
|
|
|
|
|
TEMPEST THERAPEUTICS, INC. |
|
Consolidated Statements of Operations |
|
(in thousands, except per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Three months ended |
|
|
March 31, 2024 |
|
|
March 31, 2023 |
|
Expenses: |
|
|
|
|
|
Research and development |
$ |
4,340 |
|
|
$ |
4,678 |
|
General and administrative |
|
3,634 |
|
|
|
2,903 |
|
|
|
|
|
|
|
Operating
loss |
|
(7,974 |
) |
|
|
(7,581 |
) |
|
|
|
|
|
|
Other income
(expense), net: |
|
|
|
|
|
Interest expense |
|
(368 |
) |
|
|
(344 |
) |
Interest and other income, net |
|
438 |
|
|
|
289 |
|
|
|
|
|
|
|
Net loss |
$ |
(7,904 |
) |
|
$ |
(7,636 |
) |
Net loss per
share |
$ |
(0.36 |
) |
|
$ |
(0.55 |
) |
|
|
|
|
|
|
|
|
Investor Contacts:
Sylvia WheelerWheelhouse Life Science
Advisorsswheeler@wheelhouselsa.com
Aljanae Reynolds Wheelhouse Life Science
Advisorsareynolds@wheelhouselsa.com
_______________i If approved by the FDA
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