TempestTx, Inc.

SOUTH SAN FRANCISCO, Calif., Nov. 22, 2022 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company focused on developing first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, today announced that management will participate in a fireside chat at the Piper Sandler 34th Annual Healthcare Conference on Tuesday, November 29, 2022 at 11:30 am ET. To access the live or archived recording of the chat, please visit the investor section of the Tempest website at https://ir.tempesttx.com. 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’s two novel clinical programs are TPST-1120 and TPST-1495, antagonists of PPARα and EP2/EP4, respectively. Both programs are advancing through clinical trials designed to study the agents as monotherapies and in combination with other 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 South San Francisco. More information about Tempest can be found on the company’s website at www.tempesttx.com. Investor Contacts:Sylvia WheelerWheelhouse Life Science Advisorsswheeler@wheelhouselsa.com Aljanae Reynolds Wheelhouse Life Science Advisorsareynolds@wheelhouselsa.com

TPST-1120 Late-breaking Poster Presentation at SITC Annual MeetingSecond Poster Presentation Demonstrates that Dual Blockade of EP2 and EP4 PGE2 Receptors with TPST-1495 is an Optimal Approach for Drugging the Prostaglandin Pathway SOUTH SAN FRANCISCO, Calif., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company focused on developing first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, today announced the presentation of data on TPST-1120, an oral selective peroxisome-proliferator activated receptor-alpha (PPAR-α) antagonist, and TPST-1495, a dual antagonist of both EP2 and EP4 prostaglandin (PGE2) receptors, at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting taking place November 10-12, 2022 in Boston, MA. The biomarker results presented from the TPST-1120 Phase 1 clinical study demonstrate pharmacodynamic changes in circulating blood in patients who received clinical benefit from therapy that are consistent with blocking the activity of PPAR-α. In addition, data presented from TPST-1495 showed that its dual antagonism of EP2 and EP4 generated significantly greater immune activation in human immune cells and anticancer activity in mouse tumor models than single inhibitors of either receptor, or the COX-2 inhibitor, celecoxib. “As we advance the Tempest pipeline, we continue to generate results that validate and differentiate the novel approaches of our product candidates,” said Tom Dubensky, Ph.D., president of Tempest. “For patients who responded to treatment with TPST-1120 in our Phase 1 study, we have identified potential biomarkers in the peripheral blood of immune activation and alleviation of immune suppression. These discoveries may enable us to identify patient populations in future clinical studies that are most likely to benefit from treatment with TPST-1120.” TPST-1120: “Pharmacodynamic and Predictive Biomarkers Associated with Response in Cancer Patients Treated with TPST-1120: a First-in-class, Small Molecule Antagonist of Peroxisome-Proliferator Activated Receptor-Alpha” In a late-breaking poster presentation, data from a Phase 1 trial with monotherapy and nivolumab combination arms were used to assess gene expression changes in post-treatment whole blood from 30 patients and to perform baseline mutational analysis on ctDNA to identify potential biomarkers. The data showed that seven genes were modulated by TPST-1120 exposure (p<0.05), including genes associated with enhanced immune responsiveness (CXCL16, TNFRSF1A), stimulation of monocytes or macrophages (ITGAX, FCGR2A) and PPAR-α blockade (NCF4). The results were consistent across monotherapy and combination arms. Patients in the combination arm who had a partial response (PR) to treatment had significant elevations (p<0.05) in multiple genes, including those associated with Th17 development (RORC), lipid transport (APOE) and down-regulation of CD155, a TIGIT ligand. Mutational analysis revealed that patients with a PR or stable disease were more likely to bear mutations in isocitrate dehydrogenase (IDH) and phosphatase and tensin homolog (PTEN) compared to patients with progressive disease. TPST-1495: “Dual Blockade of the EP2 and EP4 PGE2 Receptors with TPST-1495 is an Optimal Approach for Drugging the Prostaglandin Pathway” In a second presentation, the data demonstrated that TPST-1495 was more effective than EP2 and EP4 single antagonists, and the COX-2 antagonist, celecoxib, in mouse and human whole blood assays. TPST-1495 conferred a near complete restoration of immune function in cellular assays, even in the presence of high PGE2 concentrations. In lung carcinoma tumors and in a spontaneous tumor mouse model of CRC, TPST-1495 decreased tumor size and number of tumors. Immunohistochemistry analysis of the resected small intestine tumors revealed increased immune infiltrate and an enhanced adaptive immune transcriptional profile. 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’s two novel clinical programs are TPST-1120 and TPST-1495, antagonists of PPARα and EP2/EP4, respectively. Both programs are advancing through clinical trials designed to study the agents as monotherapies and in combination with other 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 South San Francisco. 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. (“Tempest Therapeutics”). 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 results of studies, future clinical study plans, commencement of, or availability of data from, clinical trials, or the benefits that may be derived from any future products. Forward-looking statements are based on information available to Tempest Therapeutics as of the date hereof and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation, the progress, scope or timing of the development of our product candidates. These and other risks are described in greater detail in the Form 10-Q filed by Tempest Therapeutics with the Securities and Exchange Commission on November 8, 2022. 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. Investor Contacts:Sylvia WheelerWheelhouse Life Science Advisorsswheeler@wheelhouselsa.com Aljanae Reynolds Wheelhouse Life Science Advisorsareynolds@wheelhouselsa.com

SOUTH SAN FRANCISCO, Calif., Nov. 08, 2022 (GLOBE NEWSWIRE) -- 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 quarter ended September 30, 2022 and provided a corporate update. “The Tempest team remained focused and continued to execute productively throughout the third quarter,” said Stephen R. Brady, chief executive officer of Tempest. “We look forward to presenting data from our diversified pipeline of novel preclinical and clinical oncology programs, including at the upcoming SITC annual meeting and in 2023 from our ongoing first-line randomized study with F. Hoffmann La Roche comparing TPST-1120 plus atezolizumab and bevacizumab in patients with liver cancer against the standard of care doublet of atezolizumab and bevacizumab.” Recent Highlights TPST-1120 (clinical PPARα antagonist): continued enrollment in a first-line, randomized global Phase 1b/2 study in patients with hepatocellular carcinoma (HCC), under a collaboration with F. Hoffmann La Roche (Roche).TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): continued enrollment in a Phase 1 study evaluating both monotherapy and combination therapy (with anti-PD-1 checkpoint inhibitor, pembrolizumab) dose and schedule optimization arms, towards establishing a recommended Phase 2 dose. 1 If approved by the FDA Planned Near-Term Milestones TPST-1120 (clinical PPARα antagonist): (i) late-breaking presentation of TPST-1120 potential patient biomarker data at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting; and (ii) early data from the first 40 patients in the first-line randomized global Phase 1b/2 study in patients with HCC under a collaboration with Roche expected in the first half of 2023. TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) presentation of additional TPST-1495 preclinical data at the 37th SITC Annual Meeting; and (ii) data from Phase 1 monotherapy and combination dose and schedule optimization arms expected by year end or early 2023, with planned presentation of the combined data in 2023.TREX-1 Inhibitor (preclinical tumor-selective STING pathway activator): planned selection of development candidate in 2023. Financial Results Third Quarter Tempest ended the third quarter of 2022 with $42.8 million in cash and cash equivalents, compared to $51.8 million on December 31, 2021. The decrease was primarily due to cash used in operations of $24.6 million offset by net proceeds from the issuance of common stock of $8.8 million and pre-funded warrants of $7.3 million. Net loss and net loss per share for the third quarter of 2022 were $8.9 million and $0.66, respectively, compared to $8.1 million and $1.21, respectively, for the third quarter of 2021.Research and development expenses for the third quarter of 2022 were $6.0 million compared to $4.6 million for the same period in 2021. The $1.4 million increase was primarily attributable to expanded research and development efforts and higher compensation expenses due to an increase in employee headcount.General and administrative expenses for the third quarter of 2022 were $2.8 million compared to $3.1 million for the same period in 2021. The decrease of $0.3 million was primarily due to lower consulting and professional services. Year-to-Date Net cash used in operations for the nine months ended September 30, 2022 was $24.6 million.Net loss and net loss per share for the nine months ended September 30, 2022 were $26.6 million and $2.46, respectively, compared to $20.5 million and $7.49, respectively, for the same period in 2021.Research and development expenses for the nine months ended September 30, 2022 were $16.7 million compared to $12.5 million for the same period in 2021. The $4.2 million increase was primarily due to expanded research and development efforts and higher personnel-related costs.For the nine months ended September 30, 2022, general and administrative expenses were $9.0 million compared to $7.2 million for the same period in 2021. The increase of $1.8 million was primarily due to an increase in professional and consulting fees and higher insurance expense as a result of operating as a publicly-traded company. 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’s two novel clinical programs are TPST-1120 and TPST-1495, antagonists of PPARα and EP2/EP4, respectively. Both programs are advancing through clinical trials designed to study the agents as monotherapies and in combination with other 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 South San Francisco. 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. (“Tempest Therapeutics”). 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 timing and selection of development candidates, dose selection or commencement of, or availability of data from, clinical trials, the company’s guidance regarding cash resources, as well as our operational plans and the timing and ability to deliver on value-creating milestones. Forward-looking statements are based on information available to Tempest Therapeutics as of the date hereof and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement. These and other risks are described in greater detail in the Form 10-Q filed by Tempest Therapeutics with the Securities and Exchange Commission on November 8, 2022. 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, 2022 December 31, 2021 Assets Current assets Cash and cash equivalents$42,791 $51,829 Insurance recovery of legal settlement 15,200 15,000 Prepaid expenses and other current assets 2,266 2,134 Total current assets 60,257 68,963 Property and equipment, net 919 1,113 Operating lease right-of-use assets 1,312 3,051 Other noncurrent assets 683 111 Total assets$63,171 $73,238 Liabilities and Stockholders' Equity Current liabilities Accounts payable$925 $991 Accrued legal settlement 15,200 15,000 Accrued expenses and other 2,585 1,589 Current loan payable 3,500 - Current operating lease liabilities 871 1,442 Accrued compensation 859 912 Interest payable 119 92 Total current liabilities 24,059 20,026 Loan payable, net 11,836 15,069 Operating lease liabilities 503 2,026 Total liabilities 36,398 37,121 Stockholders' equity Common stock 10 7 Additional paid-in capital 153,432 136,173 Accumulated deficit (126,669) (100,063) Total stockholders' equity 26,773 36,117 Total liabilities and stockholders' equity$63,171 $73,238 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, 2022 September 30, 2021 September 30, 2022 September 30, 2021Expenses: Research and development$5,973 $4,630 $16,733 $12,451 General and administrative 2,798 3,106 8,973 7,197 Total expenses 8,771 7,736 25,706 19,648 Operating loss (8,771) (7,736) (25,706) (19,648) Other income (expense), net: Interest expense (389) (437) (1,186) (944)Interest and other income, net 213 63 286 69 Net loss$(8,947) $(8,110) $(26,606) $(20,523)Net loss per share$(0.66) $(1.21) $(2.46) $(7.49) Investor Contacts:Sylvia WheelerWheelhouse Life Science Advisorsswheeler@wheelhouselsa.com Aljanae Reynolds Wheelhouse Life Science Advisorsareynolds@wheelhouselsa.com