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 March 22, 2023, Tempest Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the year ended December 31, 2022. A copy of the Company’s press release dated March 22, 2023, titled “Tempest Reports Year End 2022 Financial Results and Provides Corporate Highlights” is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The foregoing information (including the exhibit 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, 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: |
March 22, 2023 |
By: |
/s/ Stephen Brady |
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Name: |
Stephen Brady |
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Title: |
Chief Executive Officer |
Exhibit 99.1
Tempest Reports Year End 2022 Financial Results and Provides
Business Update
Brisbane, CA, March 22, 2023 – 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 year ended December 31, 2022 and provided a corporate update.
“2022 featured significant milestones for the company, including our first clinical proof of concept data, which was recognized in an oral presentation at ASCO,” said Stephen Brady, chief executive officer of Tempest. “We were pleased to see TPST-1120 confer clinical benefit to patients, including a 30% ORR at the two highest doses in patients who had not responded to checkpoint inhibitors or who had cancer that doesn’t traditionally respond to immunotherapy. We look forward to data this year from our randomized global study with Roche in first-line liver cancer patients, as well as our second clinical program, TPST-1495, where we’ve observed disease control in late-stage cancer patients, as well as data from our exciting preclinical program targeting TREX1 in the STING pathway. 2023 is shaping up to be a data-rich year for Tempest.”
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1 If approved by the FDA
Exhibit 99.1
2022 Accomplishments
Planned Near-Term Milestones
Exhibit 99.1
Financial Results
Year End 2022
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 has a diverse portfolio of novel programs ranging from early research to investigation in a randomized global study in first-line cancer patients. The company’s two novel clinical programs, TPST-1120 and TPST-1495, target PPARα and EP2/EP4, respectively, and are advancing through trials designed to study the agents as monotherapies and in combination with approved agents. Tempest is also developing an orally available inhibitor of TREX1, a target that controls activation of the cGAS/STING pathway. Tempest is headquartered in Brisbane, California. More information about Tempest can be found on the company’s website at www.tempesttx.com.
Exhibit 99.1
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 Tempest Therapeutic’s product candidates; the Company’s ability to deliver on value-creating milestones; the Company’s guidance regarding cash runway, as well as our 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, 2022 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.
Exhibit 99.1
TEMPEST THERAPEUTICS, INC. |
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Consolidated Balance Sheets |
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(in thousands) |
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December 31, 2022 |
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December 31, 2021 |
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Assets |
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Current assets |
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Cash and cash equivalents |
$ |
31,230 |
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$ |
51,829 |
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Insurance recovery of legal settlement |
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450 |
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15,000 |
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Prepaid expenses and other current assets |
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1,270 |
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2,134 |
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Total current assets |
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32,950 |
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68,963 |
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Property and equipment, net |
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1,060 |
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1,113 |
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Operating lease right-of-use assets |
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11,650 |
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3,051 |
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Other noncurrent assets |
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429 |
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111 |
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Total assets |
$ |
46,089 |
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$ |
73,238 |
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Liabilities and Stockholders' Equity |
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Current liabilities |
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Accounts payable |
$ |
1,108 |
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$ |
991 |
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Accrued legal settlement |
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450 |
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15,000 |
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Accrued expenses and other |
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2,961 |
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1,589 |
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Current operating lease liabilities |
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1,413 |
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1,442 |
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Accrued compensation |
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1,248 |
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912 |
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Interest payable |
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97 |
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92 |
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Total current liabilities |
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7,277 |
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20,026 |
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Loan payable, net |
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10,371 |
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15,069 |
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Operating lease liabilities |
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10,330 |
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2,026 |
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Total liabilities |
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27,978 |
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37,121 |
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Stockholders' equity |
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Common stock |
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11 |
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7 |
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Additional paid-in capital |
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153,872 |
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136,173 |
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Accumulated deficit |
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(135,772 |
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(100,063 |
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Total stockholders' equity |
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18,111 |
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36,117 |
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Total liabilities and stockholders' equity |
$ |
46,089 |
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$ |
73,238 |
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Exhibit 99.1
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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Twelve months ended |
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Twelve months ended |
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December 31, 2022 |
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December 31, 2021 |
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Expenses: |
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Research and development |
$ |
22,527 |
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$ |
17,166 |
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General and administrative |
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12,113 |
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9,820 |
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Total expenses |
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34,640 |
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26,986 |
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Operating loss |
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(34,640 |
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(26,986 |
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Other income (expense), net: |
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Interest expense |
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(1,618 |
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(1,282 |
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Interest and other income, net |
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549 |
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(34 |
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Net loss |
$ |
(35,709 |
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$ |
(28,302 |
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Net loss per share |
$ |
(3.09 |
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$ |
(7.47 |
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Investor Contacts:
Sylvia Wheeler
Wheelhouse Life Science Advisors
swheeler@wheelhouselsa.com
Aljanae Reynolds
Wheelhouse Life Science Advisors
areynolds@wheelhouselsa.com