TPST Tempest Therpeutics Inc

 

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 12, 2024

 

 

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:

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. ☐

 

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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
99.1	Press release dated November 12, 2024
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

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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 12, 2024	By:	/s/ Stephen Brady
		Name:	Stephen Brady
		Title:	Chief Executive Officer

 

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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

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Other Potential Future Milestones

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Financial Results

Third Quarter 2024

Year-to-Date

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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

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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.

 

 

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TEMPEST THERAPEUTICS, INC.
Consolidated Balance Sheets
(in thousands)
	September 30, 2024				December 31, 2023
Assets
Current assets
Cash and cash equivalents	$	22,116			$	39,230
Prepaid expenses and other current assets		1,436				1,133
Total current assets		23,552				40,363
Property and equipment, net		932				840
Operating lease right-of-use assets		8,904				9,952
Other noncurrent assets		448				448
Total assets	$	33,836			$	51,603
Liabilities and Stockholders' Equity
Current liabilities
Accounts payable	$	1,697			$	845
Accrued expenses		1,459				1,673
Current loan payable, net		8,504				4,285
Current operating lease liabilities		828				952
Accrued compensation		1,402				1,543
Interest payable		83				113
Total current liabilities		13,973				9,411
Loan payable, net		-				6,264
Operating lease liabilities		8,406				9,160
Total liabilities		22,379				24,835
Stockholders' equity
Common stock		27				22
Additional paid-in capital		204,723				192,009
Accumulated deficit		(193,293	)			(165,263	)
Total stockholders' equity		11,457				26,768
Total liabilities and stockholders' equity	$	33,836			$	51,603

 

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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, 2024				September 30, 2023				September 30, 2024				September 30, 2023
Expenses:
Research and development	$	7,557			$	4,221			$	17,734			$	13,315
General and administrative		2,994				2,371				10,374				8,328
Operating loss		(10,551	)			(6,592	)			(28,108	)			(21,643	)
Other income (expense), net:
Interest expense		(329	)			(373	)			(1,069	)			(1,072	)
Interest and other income, net		324				179				1,147				712
Net loss	$	(10,556	)		$	(6,786	)		$	(28,030	)		$	(22,003	)
Net loss per share	$	(0.41	)		$	(0.48	)		$	(1.19	)		$	(1.57	)

 

 

 

Investor Contacts:

Sylvia Wheeler

Wheelhouse Life Science Advisors

swheeler@wheelhouselsa.com

 

Aljanae Reynolds

Wheelhouse Life Science Advisors

areynolds@wheelhouselsa.com

i If approved by the FDA

 

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v3.24.3

Document And Entity Information	Nov. 12, 2024
Document Information [Line Items]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 12, 2024
Entity Registrant Name	Tempest Therapeutics, Inc.
Entity Central Index Key	0001544227
Entity Emerging Growth Company	false
Entity File Number	001-35890
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	45-1472564
Entity Address, Address Line One	2000 Sierra Point Parkway, Suite 400
Entity Address, City or Town	Brisbane
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94005
City Area Code	(415)
Local Phone Number	798-8589
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Common Stock [Member]
Document Information [Line Items]
Title of 12(b) Security	Common Stock, $0.001 par value
Trading Symbol	TPST
Security Exchange Name	NASDAQ
Series A Junior Participating Preferred Purchase Rights [Member]
Document Information [Line Items]
Title of 12(b) Security	Series A Junior Participating Preferred Purchase Rights
No Trading Symbol Flag	true
Security Exchange Name	NASDAQ

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