UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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:
Securities registered pursuant to Section 12(b) of the Act:
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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 12, 2024, Tempest Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2024 and other business highlights. A copy of the Company’s press release dated November 12, 2024, titled “Tempest Reports Third Quarter 2024 Financial Results and Provides Business Update” 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, 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, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
Description |
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99.1 |
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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.
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TEMPEST THERAPEUTICS, INC. |
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Date: |
November 12, 2024 |
By: |
/s/ Stephen Brady |
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Name: |
Stephen Brady |
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Title: |
Chief Executive Officer |
Exhibit 99.1
Tempest Reports Third Quarter 2024 Financial Results and
Provides Business Update
Brisbane, CA, November 12, 2024 – 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 quarter ended September 30, 2024, and provided a corporate update.
“During the third quarter, the team continued to move amezalpat successfully towards the pivotal study, achieving important milestones on both the regulatory and business fronts,” said Stephen Brady, president and chief executive officer of Tempest. “Based on the positive randomized Phase 2 data and a Phase 3 plan we believe is designed for success, we were thrilled to receive broad agreement with the FDA. Coupled with Roche’s support for the Phase 3 study, the third quarter further solidified the foundation of a pivotal study that we hope will result in a new and meaningful therapy for first-line HCC patients.”
Recent Highlights
Other Potential Future Milestones
Financial Results
Third Quarter 2024
Year-to-Date
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; Roche’s future supply of atezolizumab for use in the Company’s pivotal Phase 3 trial; anticipated therapeutic benefit and regulatory development of the Company’s product candidates; the Company’s anticipated cash runway; 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, 2024 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. |
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Consolidated Balance Sheets |
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(in thousands) |
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September 30, 2024 |
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December 31, 2023 |
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Assets |
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Current assets |
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Cash and cash equivalents |
$ |
22,116 |
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$ |
39,230 |
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Prepaid expenses and other current assets |
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1,436 |
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1,133 |
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Total current assets |
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23,552 |
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40,363 |
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Property and equipment, net |
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932 |
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840 |
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Operating lease right-of-use assets |
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8,904 |
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9,952 |
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Other noncurrent assets |
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448 |
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448 |
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Total assets |
$ |
33,836 |
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$ |
51,603 |
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Liabilities and Stockholders' Equity |
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Current liabilities |
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Accounts payable |
$ |
1,697 |
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$ |
845 |
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Accrued expenses |
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1,459 |
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1,673 |
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Current loan payable, net |
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8,504 |
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4,285 |
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Current operating lease liabilities |
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828 |
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952 |
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Accrued compensation |
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1,402 |
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1,543 |
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Interest payable |
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83 |
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113 |
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Total current liabilities |
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13,973 |
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9,411 |
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Loan payable, net |
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- |
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6,264 |
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Operating lease liabilities |
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8,406 |
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9,160 |
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Total liabilities |
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22,379 |
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24,835 |
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Stockholders' equity |
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Common stock |
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27 |
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22 |
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Additional paid-in capital |
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204,723 |
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192,009 |
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Accumulated deficit |
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(193,293 |
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(165,263 |
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Total stockholders' equity |
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11,457 |
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26,768 |
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Total liabilities and stockholders' equity |
$ |
33,836 |
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$ |
51,603 |
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TEMPEST THERAPEUTICS, INC. |
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Consolidated Statements of Operations |
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(in thousands, except per share amounts) |
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Three months ended |
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Three months ended |
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Nine months ended |
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Nine months ended |
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September 30, 2024 |
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September 30, 2023 |
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September 30, 2024 |
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September 30, 2023 |
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Expenses: |
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Research and development |
$ |
7,557 |
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$ |
4,221 |
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$ |
17,734 |
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$ |
13,315 |
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General and administrative |
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2,994 |
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2,371 |
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10,374 |
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8,328 |
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Operating loss |
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(10,551 |
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(6,592 |
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(28,108 |
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(21,643 |
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Other income (expense), net: |
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Interest expense |
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(329 |
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(373 |
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(1,069 |
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(1,072 |
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Interest and other income, net |
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324 |
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179 |
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1,147 |
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712 |
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Net loss |
$ |
(10,556 |
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$ |
(6,786 |
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$ |
(28,030 |
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$ |
(22,003 |
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Net loss per share |
$ |
(0.41 |
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$ |
(0.48 |
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$ |
(1.19 |
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$ |
(1.57 |
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Investor Contacts:
Sylvia Wheeler
Wheelhouse Life Science Advisors
swheeler@wheelhouselsa.com
Aljanae Reynolds
Wheelhouse Life Science Advisors
areynolds@wheelhouselsa.com
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i If approved by the FDA |