Tempest Reports Second Quarter 2022 Financial Results and Provides Business Update
August 15 2022 - 8:00AM
Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage
oncology company developing first-in-class1 therapeutics that
combine both targeted and immune-mediated mechanisms, today
reported financial results for the quarter ended June 30, 2022 and
provided a corporate update.
“In the second quarter, we presented promising
trial results from TPST-1120, our novel PPARα antagonist, at the
ASCO Annual Meeting. This was the first presentation of clinical
data from a Tempest program: a significant milestone for the
company that was enhanced by its selection for a podium
presentation,” said Stephen R. Brady, chief executive officer of
Tempest. “In addition to progress on our other programs, we closed
a financing with support from both a new, top-tier investor and our
founding investor that extended Tempest’s runway into the first
quarter of 2024, providing additional stability during this
turbulent time in the biotech capital markets.”
Recent Highlights
-
TPST-1120 (clinical PPARα antagonist): (i)
presented data from the monotherapy and combination therapy arms of
the TPST-1120 Phase 1 study in an oral presentation at the American
Society of Clinical Oncology (ASCO) 2022 Annual Meeting; (ii)
hosted a well-attended investor event at ASCO during which multiple
key thought leaders discussed Tempest’s programs; and (iii)
continued enrollment in a first-line, randomized global Phase 1b/2
study in patients with hepatocellular carcinoma (HCC), under a
collaboration with F. Hoffmann La Roche.
-
TPST-1495 (clinical dual EP2/4 prostaglandin
receptor antagonist): (i) continued enrollment in a Phase 1 study
evaluating both monotherapy and combination (with anti-PD-1
checkpoint inhibitor, pembrolizumab) dose and schedule optimization
arms, towards establishing an RP2D; (ii) presented a “trials in
progress” poster for the ongoing TPST-1495 Phase 1 monotherapy and
combination therapy clinical trial at ASCO; and (iii) presented
preclinical data further differentiating TPST-1495 from other
approaches targeting the prostaglandin E2 (PGE2) pathway at the
American Association for Cancer Research (AACR) 2022 Annual
Meeting.
-
TREX-1 Inhibitor (preclinical tumor-selective
STING pathway activator): presented the first data with proprietary
targeted molecules demonstrating therapeutic benefit in
tumor-bearing mice at the AACR 2022 Annual Meeting.
-
Financing: closed $15 million private investment
in public equity (PIPE) financing with new investor, EcoR1 Capital,
and founding investor, Versant Venture Capital.
Planned Near-Term
Milestones
-
TPST-1120 (clinical PPARα antagonist): early data
from the first 40 patients in the first-line randomized global
Phase 1b/2 study in patients with HCC under a collaboration with F.
Hoffmann La Roche expected by year end or early 2023.
-
TPST-1495 (clinical dual EP2/4 prostaglandin
receptor antagonist): data from Phase 1 monotherapy and combination
dose and schedule optimization arms expected by year end or early
2023, with planned presentation of the combined data in 2023.
-
TREX-1 Inhibitor (preclinical tumor-selective
STING pathway activator): planned selection of development
candidate in the second half of 2022.
Financial Results
Second Quarter
- Tempest ended
the second quarter of 2022 with $51.6 million in cash and cash
equivalents, compared to $51.8 million at December 31, 2021. The
decrease was primarily due to cash used in operations of $15.5
million offset by proceeds from the PIPE financing of $14.5 million
(net of issuance costs).
- Net loss and net
loss per share for the second quarter of 2022 were $9.2 million and
$0.79, respectively, compared to $7.1 million and $7.63,
respectively, for the second quarter of 2021.
- Research and
development expenses for the second quarter of 2022 were $5.7
million compared to $4.2 million for the same period in 2021. The
$1.5 million increase was primarily attributable to expanded
research and development efforts and higher compensation expenses
due to an increase in employee headcount.
- General and
administrative expenses for the second quarter of 2022 were $3.1
million compared to $2.6 million for the same period in 2021. The
increase of $0.5 million was primarily due to higher professional
and consulting fees and insurance expense as a result of operating
as a publicly-traded company.
Year-to-Date
- Net cash used in
operations for the six months ended June 30, 2022 was $15.5
million.
- Net loss and net
loss per share for the six months ended June 30, 2022 were $17.7
million and $1.88, respectively, compared to $12.4 million and
$17.30, respectively, for the same period in 2021.
- Research and
development expenses for the six months ended June 30, 2022 were
$10.8 million compared to $7.8 million for the same period in 2021.
The $3.0 million increase was primarily due to expanded research
and development efforts and higher personnel-related costs.
- For the six
months ended June 30, 2022, general and administrative expenses
were $6.2 million compared to $4.1 million for the same period in
2021. The increase of $2.1 million was primarily due to an increase
in professional and consulting fees and higher insurance expense as
a result of operating as a publicly-traded company.
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’s two novel clinical
programs are TPST-1120 and TPST-1495, antagonists of PPARα and
EP2/EP4, respectively. Both programs are advancing through clinical
trials designed to study both agents as monotherapies and in
combination with other approved agents. Tempest is also developing
an orally-available inhibitor of TREX-1, a DNA repair enzyme that
controls activation of the cGAS/STING pathway, an innate immune
response pathway important for the development of anti-tumor
immunity. Tempest is headquartered in South San Francisco. 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. (“Tempest Therapeutics”).
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 timing and selection of development candidates, dose selection
or commencement of, or availability of data from, clinical trials,
the company’s guidance regarding cash resources, as well as our
operational plans and the timing and ability to deliver on
value-creating milestones. Forward-looking statements are based on
information available to Tempest Therapeutics as of the date hereof
and are not guarantees of future performance. Actual results could
differ materially from those contained in any forward-looking
statement. These and other risks are described in greater
detail in the Form 10-Q filed by Tempest Therapeutics with the
Securities and Exchange Commission on August 15, 2022. 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) |
|
|
|
|
|
June 30, 2022 |
|
December 31, 2021 |
Assets |
|
|
|
Current
assets |
|
|
|
Cash and cash equivalents |
$ |
51,621 |
|
|
$ |
51,829 |
|
Insurance recovery of legal settlement |
|
15,000 |
|
|
|
15,000 |
|
Prepaid expenses and other current assets |
|
1,686 |
|
|
|
2,134 |
|
Total current assets |
|
68,307 |
|
|
|
68,963 |
|
|
|
|
|
Property and
equipment, net |
|
1,011 |
|
|
|
1,113 |
|
Operating
lease right-of-use assets |
|
1,553 |
|
|
|
3,051 |
|
Other
noncurrent assets |
|
480 |
|
|
|
111 |
|
|
|
|
|
Total assets |
$ |
71,351 |
|
|
$ |
73,238 |
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
Current
liabilities |
|
|
|
Accounts payable |
$ |
1,448 |
|
|
$ |
991 |
|
Accrued legal settlement |
|
15,000 |
|
|
|
15,000 |
|
Current loan payable |
|
2,000 |
|
|
|
- |
|
Accrued expenses and other |
|
2,824 |
|
|
|
2,501 |
|
Current operating lease liabilities |
|
1,050 |
|
|
|
1,442 |
|
Interest payable |
|
101 |
|
|
|
92 |
|
Total current liabilities |
|
22,423 |
|
|
|
20,026 |
|
|
|
|
|
Loan
payable, net |
|
13,301 |
|
|
|
15,069 |
|
Operating
lease liabilities |
|
695 |
|
|
|
2,026 |
|
Total liabilities |
|
36,419 |
|
|
|
37,121 |
|
|
|
|
|
Stockholders' equity |
|
|
|
Common stock |
|
10 |
|
|
|
7 |
|
Additional paid-in capital |
|
152,644 |
|
|
|
136,173 |
|
Accumulated deficit |
|
(117,722 |
) |
|
|
(100,063 |
) |
Total stockholders' equity |
|
34,932 |
|
|
|
36,117 |
|
Total liabilities and stockholders' equity |
$ |
71,351 |
|
|
$ |
73,238 |
|
|
|
|
|
TEMPEST
THERAPEUTICS, INC. |
Consolidated
Statements of Operations |
(in
thousands except per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended |
|
Three months
ended |
|
Six months
ended |
|
Six months
ended |
|
June 30, 2022 |
|
June 30, 2021 |
|
June 30, 2022 |
|
June 30, 2021 |
Expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
5,651 |
|
|
$ |
4,229 |
|
|
$ |
10,760 |
|
|
$ |
7,821 |
|
General and administrative |
|
3,123 |
|
|
|
2,556 |
|
|
|
6,175 |
|
|
|
4,091 |
|
|
|
|
|
|
|
|
|
Total expenses |
|
8,774 |
|
|
|
6,785 |
|
|
|
16,935 |
|
|
|
11,912 |
|
|
|
|
|
|
|
|
|
Operating loss |
|
(8,774 |
) |
|
|
(6,785 |
) |
|
|
(16,935 |
) |
|
|
(11,912 |
) |
|
|
|
|
|
|
|
|
Other income (expense), net: |
|
|
|
|
|
|
|
Interest expense |
|
(464 |
) |
|
|
(276 |
) |
|
|
(797 |
) |
|
|
(507 |
) |
Interest and other income, net |
|
70 |
|
|
|
3 |
|
|
|
73 |
|
|
|
6 |
|
|
|
|
|
|
|
|
|
Net
loss |
$ |
(9,168 |
) |
|
$ |
(7,058 |
) |
|
$ |
(17,659 |
) |
|
$ |
(12,413 |
) |
Net
loss per share |
$ |
(0.79 |
) |
|
$ |
(7.63 |
) |
|
$ |
(1.88 |
) |
|
$ |
(17.30 |
) |
|
|
|
|
|
|
|
|
Investor Contacts:Sylvia WheelerWheelhouse Life
Science Advisorsswheeler@wheelhouselsa.com
Aljanae Reynolds Wheelhouse Life Science
Advisorsareynolds@wheelhouselsa.com
1 If approved by the FDA
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