Tempest Reports Third Quarter 2023 Financial Results and Provides Business Update
08 Novembro 2023 - 7:17PM
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 third quarter ended September
30, 2023 and provided a corporate update.
“We were extremely pleased to see the pronounced
external validation of the new data showing the clear 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. “The data have not only improved
since the earlier interim analysis, but also include exciting new
biomarker results showing that the addition of TPST-1120
effectively rescues the standard of care in PD-L1 negative
patients, as well as producing an increased response rate in
patients with a b-catenin mutation. Armed with these data and a
stronger balance sheet, we are engaged in discussions with
potential partners and intend to move TPST-1120 forward in liver
cancer, as well as potentially in other indications like kidney
cancer given positive signals observed in earlier studies.”
Recent Highlights
- TPST-1120
(clinical PPARα antagonist): Reported data demonstrating
superiority of TPST-1120 across multiple study endpoints in
first-line hepatocellular carcinoma. The ongoing randomized
trial is evaluating TPST-1120 combined with the standard-of-care
regimen of atezolizumab and bevacizumab compared to standard of
care alone. 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
- TPST-1495
(clinical dual EP2/4 prostaglandin receptor antagonist): Continued
enrollment of an endometrial cancer-specific arm investigating the
two highest doses of TPST-1495 in combination with
pembrolizumab.
- Stockholder Rights
Plan: Adopted a limited duration stockholder rights plan
on October 10, 2023 to enable all Tempest stockholders to realize
the long-term value of their investment. The rights plan is
intended to reduce the likelihood that any person or group gains
control of Tempest through open market accumulation without paying
stockholders an appropriate control premium or without providing
the Board sufficient time to make informed judgments and take
actions that are in the best interests of all stockholders.
Potential Future Milestones
- TPST-1120
(clinical PPARα antagonist): Plan to advance TPST-1120 into a
registrational study in first-line liver cancer patients, likely in
connection with a partnership.
- TPST-1495
(clinical dual EP2/4 prostaglandin receptor antagonist): Expect 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): Plan to
advance new proprietary small molecule series TREX1 inhibitors
generated through insights resulting from human TREX1-inhibitor
co-crystal structures with the goal to select a lead or development
candidate by the end of 2023 or early 2024.
Interim Cash Guidance
- As of November 7, 2023, preliminary
cash and cash equivalents were $32.8 million, which reflects $23.9
million of net proceeds raised pursuant to the Company’s
at-the-market (ATM) program. The results for the quarter-to-date
period are preliminary, unaudited and are not necessarily
indicative of the results that may be expected for the full quarter
or year ending December 31, 2023.
- New capital plus the cash and cash
equivalents as of the end of the third quarter of 2023 extends the
Company’s cash runway into 2025.
Financial Results
Third Quarter 2023
- Cash and cash
equivalents at the end of the third quarter were $11.1
million, compared to $31.2 million on December 31, 2022.
- Net loss and net loss per
share for the quarter ended September 30, 2023 were $6.8
million and $0.48, respectively, compared to $8.9 million and
$0.66, respectively, for the same period in 2022.
- Research and development
expenses for the quarter ended September 30, 2023 were
$4.2 million compared to $6.0 million for the same period in 2022.
The $1.8 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 ended September 30, 2023 were
$2.4 million compared to $2.8 million for the same period in 2022.
The decrease was primarily due to a decrease in consulting and
professional expenses and personnel costs.
Year-to-Date
- Net cash used in
operations for the nine months ended September 30, 2023 was $21.2
million.
- Net loss and net loss per
share for the nine months ended September 30, 2023 were
$22.0 million and $1.57, respectively, compared to $26.6 million
and $2.46, respectively, for the same period in 2022.
- Research and development
expenses for the nine months ended September 30, 2023 were
$13.3 million compared to $16.7 million for the same period in
2022. The $3.4 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 facilities
expenses.
- General and administrative
expenses for the nine months ended September 30, 2023 were
$8.3 million compared to $9.0 million for the same period in 2022.
The $0.7 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 the Company’s product
candidates; the Company’s ability to deliver on potential
value-creating milestones; the Company’s ability to achieve its
operational plans; the Company’s ability to find a suitable partner
to develop TPST-1120 in first-line liver cancer patients; and the
Company’s preliminary cash and cash equivalents as of November 7,
2023. 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 September 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.
TEMPEST THERAPEUTICS, INC. |
|
Consolidated Balance Sheets |
|
(in thousands) |
|
|
|
|
|
|
|
|
September 30, 2023 |
|
|
December 31, 2022 |
|
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
11,118 |
|
|
$ |
31,230 |
|
Insurance recovery of legal settlement |
|
- |
|
|
|
450 |
|
Prepaid expenses and other current assets |
|
1,173 |
|
|
|
1,270 |
|
Total current assets |
|
12,291 |
|
|
|
32,950 |
|
|
|
|
|
|
|
Property and equipment,
net |
|
921 |
|
|
|
1,060 |
|
Operating lease right-of-use
assets |
|
10,382 |
|
|
|
11,650 |
|
Other noncurrent assets |
|
393 |
|
|
|
429 |
|
|
|
|
|
|
|
Total assets |
$ |
23,987 |
|
|
$ |
46,089 |
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts payable |
$ |
1,139 |
|
|
$ |
1,108 |
|
Accrued legal settlement |
|
- |
|
|
|
450 |
|
Accrued expenses and other |
|
1,995 |
|
|
|
2,961 |
|
Current loan payable, net |
|
2,134 |
|
|
|
- |
|
Current operating lease liabilities |
|
1,117 |
|
|
|
1,413 |
|
Accrued compensation |
|
931 |
|
|
|
1,248 |
|
Interest payable |
|
106 |
|
|
|
97 |
|
Total current liabilities |
|
7,422 |
|
|
|
7,277 |
|
|
|
|
|
|
|
Loan payable, net |
|
8,371 |
|
|
|
10,371 |
|
Operating lease
liabilities |
|
9,384 |
|
|
|
10,330 |
|
Total liabilities |
|
25,177 |
|
|
|
27,978 |
|
|
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
Common stock |
|
14 |
|
|
|
11 |
|
Additional paid-in capital |
|
156,571 |
|
|
|
153,872 |
|
Accumulated deficit |
|
(157,775 |
) |
|
|
(135,772 |
) |
Total stockholders' equity |
|
(1,190 |
) |
|
|
18,111 |
|
Total liabilities and stockholders' equity |
$ |
23,987 |
|
|
$ |
46,089 |
|
TEMPEST THERAPEUTICS, INC. |
|
Consolidated Statements of Operations |
|
(in thousands, except per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Three months ended |
|
|
Nine months ended |
|
|
Nine months ended |
|
|
September 30, 2023 |
|
|
September 30, 2022 |
|
|
September 30, 2023 |
|
|
September 30, 2022 |
|
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
4,221 |
|
|
$ |
5,973 |
|
|
$ |
13,315 |
|
|
$ |
16,733 |
|
General and administrative |
|
2,371 |
|
|
|
2,798 |
|
|
|
8,328 |
|
|
|
8,973 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expenses |
|
6,592 |
|
|
|
8,771 |
|
|
|
21,643 |
|
|
|
25,706 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss |
|
(6,592 |
) |
|
|
(8,771 |
) |
|
|
(21,643 |
) |
|
|
(25,706 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense), net: |
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
(373 |
) |
|
|
(389 |
) |
|
|
(1,072 |
) |
|
|
(1,186 |
) |
Interest and other income, net |
|
179 |
|
|
|
213 |
|
|
|
712 |
|
|
|
286 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(6,786 |
) |
|
$ |
(8,947 |
) |
|
$ |
(22,003 |
) |
|
$ |
(26,606 |
) |
Net loss per
share |
$ |
(0.48 |
) |
|
$ |
(0.66 |
) |
|
$ |
(1.57 |
) |
|
$ |
(2.46 |
) |
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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