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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section
13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 13, 2026
Tempest Therapeutics,
Inc.
(Exact name of
Registrant as Specified in Its Charter)
| Delaware |
|
001-35890 |
|
45-1472564 |
(State or Other Jurisdiction
of Incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
| 2000 Sierra Point Parkway, Suite 400 |
|
|
| Brisbane, California |
|
94005 |
| (Address of Principal Executive Offices) |
|
(Zip Code) |
| Registrant’s Telephone Number,
Including Area Code: (415) 798-8589 |
(Former Name
or Former Address, if Changed Since Last Report)
Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant
to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
| Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
| Common Stock, $0.001 par value |
|
TPST |
|
The Nasdaq Stock Market LLC |
| Series A Junior Participating Preferred Purchase
Rights |
|
N/A |
|
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2
of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate
by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations
and Financial Condition.
On November 13, 2026, Tempest Therapeutics,
Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2026 and other
business highlights. A copy of the Company’s press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The foregoing information (including
Exhibit 99.1 hereto) is being furnished under “Item 2.02 Results of Operations and Financial Condition” and shall not be
deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”),
or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities
Act of 1933, as amended or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and
Exhibits.
(d) Exhibits.
| Exhibit No. |
|
Description |
| |
|
|
| 99.1 |
|
Press release dated November 13, 2026 |
| |
|
|
| 104 |
|
Cover Page Interactive Data File (embedded within
the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the
Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly
authorized.
| |
TEMPEST THERAPEUTICS, INC. |
| |
|
|
| Date: November 13, 2026 |
By: |
/s/ Matthew Angel |
| |
Name: |
Matthew Angel |
| |
Title: |
President and Chief Executive Officer |
Exhibit 99.1

Tempest Reports Third Quarter 2026 Financial
Results and
Provides Business Update
Exclusively licensed Senlang’s CD7-Targeted
lentiviral in vivo CAR-T
platform following initial Phase 1 results with lead BCMA/GPRC5D candidate TPST-4903
Secured access to additional capital through
an equity line of credit with Lincoln Park
Capital Fund of up to $50.0 million and a private placement with gross proceeds of
approximately
$2.5 million
Strengthened Board of Directors with the appointments
of Nancy Freda-Smith and John W. Frederick
Brisbane, Calif., November 13, 2026 – Tempest Therapeutics, Inc. (Nasdaq: TPST)
(“Tempest”), a clinical-stage biotechnology company developing a pipeline of advanced in vivo chimeric antigen receptor
T-cell (“CAR-T”) product candidates to treat cancer and autoimmune disease, today reported financial results for the quarter
ended September 30, 2026, and provided a business update.
“The third quarter marked
a period of meaningful progress in the advancement of two next-generation in vivo CAR-T platforms with the potential to transform
treatment across multiple diseases,” said Matt Angel, Ph.D., president and chief executive officer of Tempest. “We made important
strides in expanding our pipeline and strengthening our position in the rapidly evolving in vivo CAR-T landscape through our strategic
collaboration with Senlang by obtaining exclusive license rights to our clinical-stage BCMA/GPRC5D in vivo CAR-T candidate TPST-4903,
while securing access to additional capital to support our development priorities. We also welcomed two accomplished independent directors
to our Board, bringing valuable corporate governance and capital markets expertise as we navigate our next phase of growth. Together,
these achievements reinforce our commitment to advancing our pipeline, executing on our strategic priorities and unlocking the broad therapeutic
potential of in vivo CAR-T therapies for patients.”
Recent Highlights
| ● | Exercised option under agreement with Hebei Senlang Biotechnology Co.,
Ltd. to obtain an exclusive license to develop and commercialize Senlang’s CD7-targeted lentiviral vector platform and associated
in vivo CAR-T candidates worldwide, excluding China. |
| ● | The lead program, TPST-4903, is a BCMA/GPRC5D dual-targeting in
vivo CAR-T candidate being evaluated in a Phase 1 dose-escalation study in patients with relapsed or refractory multiple myeloma (rrMM).
The initial data demonstrating encouraging preliminary clinical responses are expected to be presented at an upcoming scientific conference. |
| ● | Unveiled next-generation in vivo CAR-T pipeline, including lead
product candidate TPST-4003, a dual-targeting CD19/BCMA in vivo CAR-T candidate that combines the Company’s proprietary CD7-targeted
mRNA/LNP delivery with its clinically validated dual-target CAR architecture for broad B-cell lineage depletion and reset. |
| ● | Executed a strategic partnership in July 2026 with Hebei Senlang Biotechnology
to collaborate on the development of certain of Tempest’s proprietary in vivo CAR-T product candidates, including the
Company’s next-generation CD7-targeted TPST-4003. An investigator-initiated trial in China evaluating TPST-4003 in approximately
10 patients with myasthenia gravis or multiple sclerosis is expected to begin in the fourth quarter of 2026. |
| ● | Completed
a private placement in September 2026 of pre-funded warrants and Series C and D warrants for gross proceeds of approximately $2.5 million
(approximately $1.8 million net of placement agent fees and offering expenses), excluding up to approximately $5.0 million of gross proceeds
that may be received upon the cash exercise of the Series C and D warrants. |
| ● | Entered
into a purchase agreement with Lincoln Park Capital Fund, LLC on August 13, 2026 that gives Tempest the right, but not the obligation,
to sell up to $25.0 million of its common stock, increasing to $50.0 million if the initial amount is sold, over a 24-month period that
began September 1, 2026.Through September 30, 2026, Tempest sold 350,000 shares to Lincoln Park for gross proceeds of approximately $0.3
million. |
| ● | Strengthened
Board of Directors with the appointments of independent directors, Nancy Freda-Smith and John W. Frederick boosting corporate governance
and capital markets expertise. |
Financial Results
Third Quarter 2026
| ● | Tempest
ended the quarter with $0.9 million in cash and cash equivalents, compared to $7.7 million on December 31, 2025. The decrease was
primarily due to cash used in operations, including one-time transaction-associated costs incurred prior to or upon closing of the Asset
Acquisition in February 2026, offset by the net proceeds from the Company’s private placement of common stock and warrants in March
2026 of $1.7 million, the warrant inducement in May 2026 of $1.7 million, sales of common stock under the Lincoln Park equity line of
credit of $0.3 million and the Company’s private placement in September 2026 of $1.8 million. The Company’s existing cash
and cash equivalents are expected to fund its projected operating expense requirements for less than 12 months from the date the financial
statements were available to be issued, and there is substantial doubt about the Company’s ability to continue as a going concern. |
| ● | Net
loss and net loss per share for the quarter were $3.6 million and $0.21, respectively, compared to $3.5 million and $0.79, respectively,
for the three months ended September 30, 2025. |
| ● | Research
and development expenses for the quarter were $0.2 million compared to $0.6 million for the three months ended September 30, 2025. The
$0.4 million decrease was primarily due to a decrease in costs incurred as a result of the portfolio re-prioritization after the Asset
Acquisition in February 2026, offset by research and manufacturing costs related to the Company’s CAR-T product candidates. |
| ● | General
and administrative expenses for the quarter were $2.6 million compared to $3.0 million for the same period in 2025. The $0.4 million
decrease was primarily due to a decrease in one-time separation and other costs incurred in the third quarter of 2025, offset by other
administrative expenses. |
| ● | Financing
costs related to the Lincoln Park equity line of credit for the quarter were $0.8 million, consisting of $0.66 million for the fair value
of the commitment shares issued to Lincoln Park and $0.15 million of issuance costs, net of a nominal gain on shares sold to Lincoln
Park. There were no financing costs in the three months ended September 30, 2025. |
Nine Months Ended September 30, 2026
| ● | Cash
used in operating activities for the nine months ended September 30, 2026 was $12.4 million. |
| ● | Net
loss and net loss per share for the nine months ended September 30, 2026 were $36.6 million and $2.54, respectively, compared to $22.2
million and $5.71, respectively, for the same period in 2025. |
| ● | Research
and development expenses for the nine months ended September 30, 2026 were $2.1 million, compared to $12.1 million for the same period
in 2025. The $9.9 million decrease was primarily due to a decrease in costs incurred as a result of re-prioritizing efforts towards
exploring strategic alternatives initiated in April 2025 and resulting in the Asset Acquisition completed in February 2026. |
| ● | General
and administrative expenses for the nine months ended September 30, 2026 were $11.5 million, compared to $10.4 million for the same period
in 2025. The $1.0 million increase was primarily due to one-time costs resulting from the Asset Acquisition completed in February 2026. |
| ● | Acquired
in-process research and development expenses for the nine months ended September 30, 2026 were $22.2 million compared to nil for the
nine months ended September 30, 2025. Costs incurred prior to or upon closing the Asset Acquisition in the prior three months ended
March 31, 2026 were expensed as acquired in-process research and development. |
| ● | Financing
costs related to the Lincoln Park equity line of credit for the nine months ended September 30, 2026 were $0.8 million, all of which
were recognized in the third quarter of 2026. There were no financing costs in the nine months ended September 30, 2025. |
About Tempest Therapeutics
Tempest is a clinical-stage biotechnology
company developing a pipeline of advanced in vivo CAR-T therapies designed to treat cancer and autoimmune disease by
resetting dysfunctional immunity. Tempest’s portfolio includes TPST-4903, a BCMA/GPRC5D dual-targeting in vivo CAR-T
candidate being evaluated in a Phase 1 study for relapsed or refractory multiple myeloma (rrMM). The Company’s lead lipid
nanoparticle (LNP)-based in vivo CAR-T candidate, TPST-4003 combines a clinically supported dual-targeting CD19/BCMA CAR structure
with an advanced CD7-targeting delivery platform to support broad immune reset across multiple indications. The company’s
additional preclinical programs leverage advanced payloads to create a modular in vivo CAR-T portfolio. Tempest envisions a
world in which immune reset therapies bring safe, effective, and broadly accessible therapeutic options to patients in need. For
additional information, visit Tempest’s website at https://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,
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,” “goal”,
“suggest”, “target” and other similar expressions. All statements that are not historical facts are forward-looking
statements, including but not limited to, statements regarding: Tempest’s collaboration with Senlang and the advancement, development,
design and potential benefits of TPST-4003; the planned investigator-initiated trial of TPST-4003, including the expected patient population,
indications, number of patients, timing of first patient enrollment and dosing, expected assessments and anticipated timing and nature
of initial and interim clinical data; Tempest’s exclusive license to develop and commercialize Senlang’s CD7-targeted
lentiviral vector platform and associated in vivo CAR-T candidates, and the anticipated benefits of that license; the advancement,
development and potential benefits of TPST-4903, including the ongoing Phase 1 dose-escalation study; the expected presentation of initial
data from that study at an upcoming scientific conference, and the nature and timing of that data; the potential applicability of Tempest’s
platform and product candidates across autoimmune and oncology indications; Tempest’s business development and partnering plans,
including in China; Tempest’s ability to access capital under its purchase agreement with Lincoln Park and the amount of proceeds
it receives; and Tempest’s need for, and ability to obtain, additional capital to fund its planned programs and operations and continue
as a going concern. All forward-looking statements in this press release are based on Tempest Therapeutics’ current expectations,
estimates and projections about its industry as well as management’s current beliefs and expectations of future events only as of
today and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those
set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to Tempest Therapeutics’
need for additional capital to fund its planned programs and operations and to continue to operate as a going concern; unexpected safety
or efficacy data observed during preclinical or clinical trials; the possibility that results from prior clinical trials and preclinical
studies may not necessarily be predictive of future results; past results may not be indicative of future results; clinical trial site
activation or enrollment rates that are lower than expected; loss of key personnel; changes in expected or existing competition; changes
in the regulatory environment; risks relating to volatility and uncertainty in the capital markets for biotechnology companies; dilution
to stockholders from sales of common stock under the Lincoln Park purchase agreement and the exercise of outstanding warrants; Tempest’s
ability to regain and maintain compliance with Nasdaq listing requirements; and unexpected litigation or other disputes. These and 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 Tempest Therapeutics’ Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange
Commission (“SEC”) on March 30, 2026, in Tempest’s Quarterly Report on Form 10-Q for the quarter ended September 30,
2026, expected to be filed with the SEC on November 13, 2026, and in other documents filed by Tempest Therapeutics from time to time with
the SEC. 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,
2026 | | |
December 31,
2025 | |
| Assets | |
| | |
| |
| Current assets | |
| | |
| |
| Cash and cash equivalents | |
$ | 897 | | |
$ | 7,707 | |
| Prepaid expenses and other current assets | |
| 712 | | |
| 562 | |
| Total current assets | |
| 1,609 | | |
| 8,269 | |
| | |
| | | |
| | |
| Property and equipment, net | |
| 429 | | |
| 605 | |
| Operating lease right-of-use assets | |
| 6,642 | | |
| 7,540 | |
| Other noncurrent assets | |
| 81 | | |
| 517 | |
| | |
| | | |
| | |
| Total assets | |
$ | 8,761 | | |
$ | 16,931 | |
| | |
| | | |
| | |
| Liabilities and Stockholders’ Equity | |
| | | |
| | |
| Current liabilities | |
| | | |
| | |
| Accounts payable | |
$ | 2,031 | | |
$ | 1,038 | |
| Accrued expenses | |
| 980 | | |
| 937 | |
| Current operating lease liabilities | |
| 1,336 | | |
| 1,192 | |
| Accrued compensation | |
| 322 | | |
| 147 | |
| Total current liabilities | |
| 4,669 | | |
| 3,314 | |
| | |
| | | |
| | |
| Operating lease liabilities | |
| 5,922 | | |
| 6,949 | |
| Total liabilities | |
| 10,591 | | |
| 10,263 | |
| | |
| | | |
| | |
| Stockholders’ equity | |
| | | |
| | |
| Common stock(1) | |
| 17 | | |
| 5 | |
| Additional paid-in capital(1) | |
| 277,098 | | |
| 240,031 | |
| Accumulated deficit | |
| (278,945 | ) | |
| (233,368 | ) |
| Total stockholders’ equity (deficit) | |
| (1,830 | ) | |
| 6,668 | |
| Total liabilities and stockholders’ equity (deficit) | |
$ | 8,761 | | |
$ | 16,931 | |
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,
2026 | | |
September 30,
2025 | | |
September 30,
2026 | | |
September 30,
2025 | |
| Expenses: | |
| | |
| | |
| | |
| |
| Research and development | |
$ | 207 | | |
$ | 570 | | |
$ | 2,140 | | |
$ | 12,067 | |
| General and administrative | |
| 2,616 | | |
| 3,027 | | |
| 11,473 | | |
| 10,431 | |
| Acquired in-process research and development | |
| - | | |
| - | | |
| 22,180 | | |
| - | |
| | |
| | | |
| | | |
| | | |
| | |
| Operating loss | |
| (2,823 | ) | |
| (3,597 | ) | |
| (35,793 | ) | |
| (22,498 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Other income (expense), net: | |
| | | |
| | | |
| | | |
| | |
| Interest expense | |
| - | | |
| - | | |
| - | | |
| (207 | ) |
| Interest and other income, net | |
| - | | |
| 86 | | |
| 30 | | |
| 464 | |
| Financing costs related to equity line of credit | |
| (806 | ) | |
| - | | |
| (806 | ) | |
| - | |
| | |
| | | |
| | | |
| | | |
| | |
| Net loss | |
$ | (3,629 | ) | |
$ | (3,511 | ) | |
$ | (36,569 | ) | |
$ | (22,241 | ) |
| Net loss per share | |
$ | (0.21 | ) | |
$ | (0.79 | ) | |
$ | (2.54 | ) | |
$ | (5.71 | ) |
Investor Contacts:
Alexandra Santos
Wheelhouse Life Science Advisors
asantos@wheelhouselsa.com
Aljanae Reynolds
Wheelhouse Life Science Advisors
areynolds@wheelhouselsa.com