Tempest Reports Year End 2023 Financial Results and Provides Business Update
19 Marzo 2024 - 2:25PM
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 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 PPARα 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-κB 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 PPARα 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
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 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
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) |
|
|
|
|
|
|
|
|
December 31, 2023 |
|
|
December 31, 2022 |
|
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
39,230 |
|
|
$ |
31,230 |
|
Insurance recovery of legal settlement |
|
- |
|
|
|
450 |
|
Prepaid expenses and other current assets |
|
1,133 |
|
|
|
1,270 |
|
Total current assets |
|
40,363 |
|
|
|
32,950 |
|
|
|
|
|
|
|
Property and equipment,
net |
|
840 |
|
|
|
1,060 |
|
Operating lease right-of-use
assets |
|
9,952 |
|
|
|
11,650 |
|
Other noncurrent assets |
|
448 |
|
|
|
429 |
|
|
|
|
|
|
|
Total assets |
$ |
51,603 |
|
|
$ |
46,089 |
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts payable |
$ |
845 |
|
|
$ |
1,108 |
|
Accrued legal settlement |
|
- |
|
|
|
450 |
|
Accrued expenses and other |
|
1,673 |
|
|
|
2,961 |
|
Current loan payable, net |
|
4,285 |
|
|
|
- |
|
Current operating lease liabilities |
|
952 |
|
|
|
1,413 |
|
Accrued compensation |
|
1,543 |
|
|
|
1,248 |
|
Interest payable |
|
113 |
|
|
|
97 |
|
Total current liabilities |
|
9,411 |
|
|
|
7,277 |
|
|
|
|
|
|
|
Loan payable, net |
|
6,264 |
|
|
|
10,371 |
|
Operating lease
liabilities |
|
9,160 |
|
|
|
10,330 |
|
Total liabilities |
|
24,835 |
|
|
|
27,978 |
|
|
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
Common stock |
|
22 |
|
|
|
11 |
|
Additional paid-in capital |
|
192,009 |
|
|
|
153,872 |
|
Accumulated deficit |
|
(165,263 |
) |
|
|
(135,772 |
) |
Total stockholders' equity |
|
26,768 |
|
|
|
18,111 |
|
Total liabilities and stockholders' equity |
$ |
51,603 |
|
|
$ |
46,089 |
|
|
|
|
|
|
|
|
|
TEMPEST THERAPEUTICS, INC. |
|
Consolidated Statements of Operations |
|
(in thousands, except per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended |
|
|
Year ended |
|
|
December 31, 2023 |
|
|
December 31, 2022 |
|
Expenses: |
|
|
|
|
|
Research and development |
$ |
17,498 |
|
|
$ |
22,527 |
|
General and administrative |
|
11,659 |
|
|
|
12,113 |
|
|
|
|
|
|
|
Operating
loss |
|
(29,157 |
) |
|
|
(34,640 |
) |
|
|
|
|
|
|
Other income
(expense), net: |
|
|
|
|
|
Interest expense |
|
(1,449 |
) |
|
|
(1,618 |
) |
Interest and other income, net |
|
1,115 |
|
|
|
549 |
|
|
|
|
|
|
|
Net loss |
$ |
(29,491 |
) |
|
$ |
(35,709 |
) |
Net loss per
share |
$ |
(1.91 |
) |
|
$ |
(3.09 |
) |
Investor Contacts:
Sylvia WheelerWheelhouse Life Science
Advisorsswheeler@wheelhouselsa.com
Aljanae Reynolds Wheelhouse Life Science
Advisorsareynolds@wheelhouselsa.com
i If approved
by the FDA
Tempest Therpeutics (NASDAQ:TPST)
Gráfica de Acción Histórica
De Abr 2024 a May 2024
Tempest Therpeutics (NASDAQ:TPST)
Gráfica de Acción Histórica
De May 2023 a May 2024