Form 8-K

8-K — Tempest Therapeutics, Inc.

Accession: 0001193125-26-224156

Filed: 2026-05-14

Period: 2026-05-14

CIK: 0001544227

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — tpst-20260514.htm (Primary)

EX-99.1 (tpst-ex99_1.htm)

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8-K

8-K (Primary)

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8-K

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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): May 14, 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 May 14, 2026, Tempest Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 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 May 14, 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:

May 14, 2026

By:

/s/ Matthew Angel

Name:

Matthew Angel

Title:

Chief Executive Officer

EX-99.1

Filename: tpst-ex99_1.htm · Sequence: 2

EX-99.1

Exhibit 99.1

Tempest Reports First Quarter 2026 Financial Results and

Provides Business Update

Announced positive interim data from the ongoing REDEEM-1 Phase 1/2a trial of TPST-2003 in patients with relapsed/refractory multiple myeloma (rrMM)

Announced Cincinnati Children’s Applied Gene and Cell Therapy Center (“AGCTC”) as Lead Manufacturing Partner

Appointed Andrew Fang, Ph.D., as Head of Business Development

Brisbane, CA, May 14, 2026 – Tempest Therapeutics, Inc. (Nasdaq: TPST) (“Tempest”), a clinical-stage biotechnology company developing a pipeline of advanced CAR-T cell therapy product candidates to treat cancer, today reported financial results for the quarter ended March 31, 2026, and provided a corporate update.

“We made strong progress in the first quarter as we continued to execute across our lead program TPST-2003,” said Matt Angel, Ph.D., President and Chief Executive Officer of Tempest. “We advanced key activities supporting the planned initiation of our U.S. registrational study of TPST-2003 in patients with rrMM, including announcing our lead manufacturing partner AGCTC and taking delivery of the TPST-2003 lentiviral vector, a critical component in the manufacturing of TPST-2003. At the same time, we strengthened our ability to unlock value across our remaining portfolio with the appointment of Andrew Fang, Ph.D., as our Head of Business Development, whose focus on strategic partnerships, licensing and corporate transactions will help position us for long-term growth. We believe these milestones further reinforce our momentum and our path toward delivering meaningful impact for patients and shareholders alike.”

Recent Highlights

•

TPST-2003

•

Positive interim results across two ongoing clinical trials (REDEEM-1 Phase 1/2a trial of TPST-2003 in patients with rrMM, and POEMS-1 Phase 1 trial evaluating TPST-2003 in the rare disease, POEMS syndrome), both of

which are being sponsored and conducted by Tempest’s partner, Novatim Immune Therapeutics:

▪

100% complete response (CR) rate among all 15 CAR-T-naïve efficacy evaluable patients treated with TPST-2003 across REDEEM-1 and POEMS-1 trials.

▪

Favorable safety profile with no Grade ≥3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) in REDEEM-1 trial appears to be emerging as a potentially differentiating attribute in its class.

▪

Prior investigator-initiated trial (IIT) reached median progression free survival (PFS) of 23.1 months, including in patients with extramedullary disease.

▪

44 patients with rrMM treated to date across three studies.

•

The selection of Cincinnati Children’s AGCTC as the lead contract development and manufacturing partner to conduct the formal technology transfer of TPST-2003, Tempest’s dual-targeting CD19/BCMA CAR-T therapy under development for the treatment of relapsed/refractory multiple myeloma (rrMM). Further to the selection of AGCTC as lead partner, AGCTC took delivery of the TPST-2003 lentiviral vector, a critical component used in the manufacturing of TPST-2003, supporting plans to initiate the first potentially registrational study to evaluate a dual-targeting CAR-T therapy in patients with rrMM, including patients who are experiencing extramedullary disease (EMD), later this year.

•

Corporate:

•

Announced the appointment of Andrew Fang, Ph.D., as Head of Business Development. In his role, Dr. Fang will lead Tempest’s global business development efforts, including strategic partnerships, cross-border licensing and corporate transactions, with a particular focus on expanding Tempest’s outreach and partnering efforts in China.

•

Announced closing of strategic asset acquisition of new dual-targeting CAR-T assets from Factor Bioscience Inc. and Erigen LLC (“Asset Acquisition”).

▪

The transaction brought Tempest a portfolio of next-generation CAR-T assets, including TPST-2003, a clinical-stage dual-targeting CD-19/BCMA CAR-T with strategic partner-funded biologics license application (“BLA”) filing in China planned for 2027.

•

In March 2026, Tempest announced up to $6 million private placement (the “2026 Offering”) of common stock and warrants, with $2 million upfront and up to $4 million of potential aggregate gross proceeds upon the exercise in full of warrants, subject to shareholder approval.

Financial Results

First Quarter 2026

•

Tempest ended the quarter with $1.8 million in cash and cash equivalents, compared to $7.7 million on December 31, 2025. The decrease was primarily due to one-time transaction-associated costs incurred prior to or upon closing the Asset Acquisition, offset by net proceeds from the 2026 Offering of $1.7 million.

•

Net loss and net loss per share for the quarter were $27.7 million and $2.53, respectively, compared to $10.9 million and $3.16, respectively, for the three months ended March 31, 2025.

•

Research and development expenses for the quarter were $0.1 million compared to $7.6 million for the three months ended March 31, 2025. The $7.5 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 quarter were $5.4 million compared to $3.3 million for the same period in 2025. The $2.1 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 quarter were $22.1 million compared to nil for the three months ended March 31, 2025. Costs incurred prior to or upon closing the Asset Acquisition in the three months ended March 31, 2026 were expensed as acquired in-process research and development.

About Tempest Therapeutics

Tempest Therapeutics is a clinical-stage biotechnology company developing a pipeline of advanced CAR-T cell therapy product candidates to treat cancer. Tempest is headquartered in Brisbane, California. More information about Tempest can be found on the company’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 Therapeutics’ plan to initiate the first potentially registrational study to evaluate a dual-targeting CAR-T therapy in patients with rrMM, focus on expanding Tempest’s outreach and partnering efforts in China, plans for BLA filing in China, and expectations regarding shareholder approval in connection with the 2026 Offering and the potential aggregate proceeds therefrom; anticipated therapeutic benefit and regulatory development of Tempest Therapeutics’ product candidates; and Tempest’s ability to promptly raise additional funds to further expand the Company’s cash runway. 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; 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, 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)

March 31, 2026

December 31, 2025

Assets

Current assets

Cash and cash equivalents

1,805

7,707

Prepaid expenses and other current assets

641

562

Total current assets

2,446

8,269

Property and equipment, net

545

605

Operating lease right-of-use assets

7,248

7,540

Other noncurrent assets

509

517

Total assets

10,748

16,931

Liabilities and Stockholders' Equity

Current liabilities

Accounts payable

585

1,038

Accrued expenses

1,162

937

Current operating lease liabilities

1,239

1,192

Accrued compensation

325

147

Total current liabilities

3,311

3,314

Operating lease liabilities

6,615

6,949

Total liabilities

9,926

10,263

Stockholders' equity

Common stock

Additional paid-in capital

270,880

240,031

Accumulated deficit

(270,072

)

(233,368

)

Total stockholders' equity

822

6,668

Total liabilities and stockholders' equity

10,748

16,931

TEMPEST THERAPEUTICS, INC.

Consolidated Statements of Operations

(in thousands, except per share amounts)

Three months ended

March 31, 2026

March 31, 2025

Expenses:

Research and development

114

7,627

General and administrative

5,425

3,309

Acquired in-process R&D

22,180

Operating loss

(27,719

)

(10,936

)

Other income (expense), net:

Interest expense

(161

)

Interest and other income, net

237

Net loss

(27,696

)

(10,860

)

Net loss per share(1)

(2.53

)

(3.16

)

(1) Results have been adjusted to reflect the one-for-thirteen reverse stock split effected in April 2025.

Investor Contacts:

Sylvia Wheeler

Wheelhouse Life Science Advisors

swheeler@wheelhouselsa.com

Aljanae Reynolds

Wheelhouse Life Science Advisors

areynolds@wheelhouselsa.com

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