Tempest Reports Second Quarter 2023 Financial Results and Provides Business Update
August 10 2023 - 4:13PM
Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage
oncology company developing first-in-classi therapeutics that
combine both targeted and immune-mediated mechanisms, today
reported financial results for the quarter ended June 30, 2023 and
provided a corporate update.
“2023 continues to be a productive and
potentially transformative year for Tempest,” said Stephen Brady,
chief executive officer of Tempest. “In the second quarter, we
presented data from our second clinical program, TPST-1495, the
company’s novel dual EP2/EP4 antagonist designed to selectively
modulate the prostaglandin pathway, both at ASCO and in a paper
published in Cancer Research Communications. These presentations
were made on the heels of announcing early exciting triplet data
from our lead TPST-1120 program demonstrating a
clinically-meaningful improvement over standard of care alone in
first-line HCC patients in an ongoing, global, randomized Phase
1b/2 study. We expect to be able to discuss an updated and
comprehensive data set from the formal review of this trial in the
second half of 2023.”
Recent Highlights
-
TPST-1120 (clinical PPARα antagonist): announced
positive early results from the ongoing randomized first-line HCC
study comparing TPST-1120 combined with the standard-of-care
regimen of atezolizumab and bevacizumab, with head-to-head to
standard-of-care alone. The data were positive in multiple
categories, and demonstrated a favorable safety profile:
- Unconfirmed
responses of 30% for the TPST-1120 triplet arm (12/40) vs. 17.2%
for the active control arm (5/29), demonstrating a 74.4% relative
improvement in objective response rate (ORR);
- Confirmed
responses of 17.5% for the TPST-1120 triplet arm (7/40) vs. 10.3%
for the active control arm (3/29), demonstrating a 69.9% relative
improvement in confirmed ORR;
- 47.5% (19/40) of
the TPST-1120 arm patients are on treatment vs. 23.3% (7/30) in the
control arm; and
- 80% (32/40) of
the TPST-1120 arm patients are on study vs. 50% (15/30) in the
control.ii
-
TPST-1495 (clinical dual EP2/4 prostaglandin
receptor antagonist): (i) presented data from a Phase 1 study
evaluating TPST-1495 as a monotherapy and in combination with the
anti-PD-1 checkpoint inhibitor pembrolizumab in advanced solid
tumors at the 2023 American Society of Clinical Oncology (ASCO)
Annual Meeting; (ii) published mechanism of action data
highlighting the increased potency of the molecule against
prostaglandin-driven tumor models in Cancer Research
Communications, a journal of the American Association for Cancer
Research; and (iii) continued enrollment of an endometrial
cancer-specific arm investigating the two highest doses of
TPST-1495 in combination with pembrolizumab.
Potential Upcoming
Milestones
-
TPST-1120 (clinical PPARα antagonist): we expect
to be able to discuss an updated and comprehensive data set from
the formal review of the ongoing, global, randomized Phase 1b/2
study in first-line liver cancer patients in the second half of
2023.
-
TPST-1495 (clinical dual EP2/4 prostaglandin
receptor antagonist): we plan to report data from the combination
arm at the two highest TPST-1495 doses in patients with advanced
endometrial cancer in 2024.
- TREX1
Inhibitor (preclinical tumor-selective STING pathway
activator): we expect to advance new proprietary small molecule
series TREX1 inhibitors generated through insights resulting from
human TREX1-inhibitor co-crystal structures.
Financial Results
Second Quarter 2023
- Tempest ended the second quarter
with $17.6 million in cash and cash equivalents, compared to $31.2
million on December 31, 2022.
- Net loss and net loss per share for
the quarter ended June 30, 2023 were $7.6 million and $0.54,
respectively, compared to $9.2 million and $0.79, respectively, for
the same period in 2022.
- Research and development expenses
for the quarter ended June 30, 2023 were $4.4 million compared to
$5.7 million for the same period in 2022. The decrease was
primarily due to a decrease in costs incurred from contract
research organizations and third-party vendors, partially offset by
an increase in personnel costs, as well as facilities
expenses.
- General and administrative expenses
for the quarter ended June 30, 2023 were $3.1 million. The decrease
was primarily due to a decrease in consulting and professional
expenses.
Year-to-Date
- Net cash used in
operations for the six months ended June 30, 2023 was $14.7
million.
- Net loss and net
loss per share for the six months ended June 30, 2023 were $15.2
million and $1.09, respectively, compared to $17.7 million and
$1.88, respectively, for the same period in 2022.
- Research and
development expenses for the six months ended June 30, 2023 were
$9.1 million compared to $10.8 million for the same period in 2022.
The $1.7 million decrease was primarily due to a decrease in costs
incurred from contract research organizations and third-party
vendors, partially offset by an increase in personnel costs, as
well as facilities expenses.
- General and
administrative expenses for the six months ended June 30, 2023 were
$6.0 million compared to $6.2 million for the same period in 2022.
The $0.2 million decrease was primarily due to a decrease in
consulting and professional expenses.
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 clinical programs, TPST-1120 and TPST-1495, target
PPARα 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. 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 Tempest Therapeutic’s product
candidates; the Company’s ability to deliver on potential
value-creating milestones; 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 June
30, 2023 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.
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TEMPEST THERAPEUTICS, INC. |
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Consolidated Balance Sheets |
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(in thousands) |
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June 30, 2023 |
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December 31, 2022 |
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Assets |
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Current assets |
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Cash and cash equivalents |
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$ |
17,604 |
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$ |
31,230 |
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Insurance recovery of legal settlement |
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|
- |
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|
450 |
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Prepaid expenses and other current assets |
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|
931 |
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|
1,270 |
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Total current assets |
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18,535 |
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32,950 |
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Property and equipment,
net |
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|
1,005 |
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|
|
1,060 |
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Operating lease right-of-use
assets |
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|
10,804 |
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11,650 |
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Other noncurrent assets |
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|
398 |
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|
429 |
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Total assets |
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$ |
30,742 |
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|
$ |
46,089 |
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Liabilities and Stockholders' Equity |
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Current liabilities |
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Accounts payable |
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$ |
868 |
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|
$ |
1,108 |
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Accrued legal settlement |
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|
- |
|
|
|
450 |
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Accrued expenses and other |
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|
2,454 |
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|
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2,961 |
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Current loan payable, net |
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|
2,974 |
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- |
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Current operating lease liabilities |
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|
1,414 |
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|
|
1,413 |
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Accrued compensation |
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|
823 |
|
|
|
1,248 |
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Interest payable |
|
|
105 |
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|
|
97 |
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Total current liabilities |
|
|
8,638 |
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|
7,277 |
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Loan payable, net |
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7,484 |
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|
|
10,371 |
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Operating lease
liabilities |
|
|
9,608 |
|
|
|
10,330 |
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Total liabilities |
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|
25,730 |
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|
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27,978 |
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Stockholders' equity |
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|
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Common stock |
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|
13 |
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11 |
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Additional paid-in capital |
|
|
155,988 |
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|
|
153,872 |
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Accumulated deficit |
|
|
(150,989 |
) |
|
|
(135,772 |
) |
Total stockholders' equity |
|
|
5,012 |
|
|
|
18,111 |
|
Total liabilities and stockholders' equity |
|
$ |
30,742 |
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$ |
46,089 |
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TEMPEST THERAPEUTICS, INC. |
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Consolidated Statements of Operations |
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(in thousands, except per share amounts) |
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Three months ended |
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Three months ended |
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Six months ended |
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Six months ended |
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June 30, 2023 |
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June 30, 2022 |
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June 30, 2023 |
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June 30, 2022 |
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Expenses: |
|
|
|
|
|
|
|
|
|
|
|
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Research and development |
|
$ |
4,416 |
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$ |
5,651 |
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|
$ |
9,094 |
|
|
$ |
10,760 |
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General and administrative |
|
|
3,054 |
|
|
|
3,123 |
|
|
|
5,957 |
|
|
|
6,175 |
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|
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|
|
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|
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Total expenses |
|
|
7,470 |
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|
|
8,774 |
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|
|
15,051 |
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|
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16,935 |
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Operating
loss |
|
|
(7,470 |
) |
|
|
(8,774 |
) |
|
|
(15,051 |
) |
|
|
(16,935 |
) |
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Other income
(expense), net: |
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Interest expense |
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(355 |
) |
|
|
(464 |
) |
|
|
(699 |
) |
|
|
(797 |
) |
Interest and other income, net |
|
|
244 |
|
|
|
70 |
|
|
|
533 |
|
|
|
73 |
|
|
|
|
|
|
|
|
|
|
|
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Net loss |
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$ |
(7,581 |
) |
|
$ |
(9,168 |
) |
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$ |
(15,217 |
) |
|
$ |
(17,659 |
) |
Net loss per
share |
|
$ |
(0.54 |
) |
|
$ |
(0.79 |
) |
|
$ |
(1.09 |
) |
|
$ |
(1.88 |
) |
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Investor Contacts:
Sylvia WheelerWheelhouse Life Science
Advisorsswheeler@wheelhouselsa.com
Aljanae Reynolds Wheelhouse Life Science
Advisorsareynolds@wheelhouselsa.com
i If approved by the FDAii As of data cutoff date,
February 8, 2023
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