TPST Tempest Therapeutics Inc.

9.6
-0.6  -6%
Previous Close 10.2
Open 9.49
52 Week Low 9.3502
52 Week High 41.55
Market Cap $66,339,801
Shares 6,910,324
Float 18,936,701
Enterprise Value $29,583,304
Volume 10,266
Av. Daily Volume 19,508
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Drug Stage Catalyst Date
TPST-1495
Solid Tumors
Phase 1
Phase 1
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TPST-1120 and OPDIVO (nivolumab)
Hepatocellular Carcinoma
Phase 1/2
Phase 1/2
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Latest News

    • Combination based on both strong mechanistic rationale and preclinical data

    SOUTH SAN FRANCISCO, Nov. 18, 2021 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (NASDAQ:TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both tumor-targeted and immune-mediated mechanisms, today announced the first patient has been dosed with TPST-1495 in combination with pembrolizumab in the Phase 1a/1b open-label, dose and schedule optimization study of TPST-1495 in patients with solid tumors.

    "We're very pleased to announce the start of patient dosing with TPST-1495 in combination with pembrolizumab," said Sam Whiting, MD, Ph.D., chief medical officer of Tempest. "TPST-1495 is designed to inhibit key components…

    • Combination based on both strong mechanistic rationale and preclinical data

    SOUTH SAN FRANCISCO, Nov. 18, 2021 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (NASDAQ:TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both tumor-targeted and immune-mediated mechanisms, today announced the first patient has been dosed with TPST-1495 in combination with pembrolizumab in the Phase 1a/1b open-label, dose and schedule optimization study of TPST-1495 in patients with solid tumors.

    "We're very pleased to announce the start of patient dosing with TPST-1495 in combination with pembrolizumab," said Sam Whiting, MD, Ph.D., chief medical officer of Tempest. "TPST-1495 is designed to inhibit key components of the Prostaglandin E2, or PGE2, pathway, which is both a driver of tumor cell proliferation and an important suppressor of anti-tumor immune function. In addition, recent data show that PGE2 is involved in enabling tumors to escape from immune checkpoint inhibitors such as pembrolizumab, a process known as adaptive immune resistance. Based on this mechanistic rationale and our preclinical data, we are excited about the potential of this combination to be superior to either approach alone and bring benefit to patients."

    The first-in-human Phase 1a/1b, multicenter, open-label, dose and schedule optimization study is being conducted at academic and Phase 1 sites in the U.S. and evaluates TPST-1495 as a single agent and in combination with pembrolizumab to determine its maximum tolerated dose and/or recommended Phase 2 dose, safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity in subjects with advanced solid tumors. The preliminary dose-finding stage of the study allows patients with any solid tumor histology, while the study expansion stages are designed both to focus upon patients with prostaglandin-driven cancers, including colorectal cancer, endometrial cancer, squamous cell carcinoma of the head and neck, as well as biomarker-selected patients with tumor-driver mutations in the PIK3CA gene, which are known to enhance the level of prostaglandin production in tumor cells.

    About TPST-1495

    TPST-1495 is an orally available small molecule designed to block the tumor-promoting EP2 and EP4 receptors in the prostaglandin (PGE2) pathway, while sparing the homologous but immune-supporting EP1 and EP3 receptors. PGE2 signaling through EP2 and EP4 has been observed both to enhance tumor progression and promote immune suppression. Tempest has conducted head-to-head preclinical studies comparing TPST-1495 to single antagonists of EP2 and EP4 and observed significantly enhanced activity of TPST-1495 in both overcoming PGE2-mediated suppression of human immune cells in vitro, as well as significantly increased anti-tumor activity in mouse models of human colorectal cancer. Tempest is currently evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and possible anti-tumor activity of TPST-1495 as a single agent and in combination with pembrolizumab in a multicenter Phase 1a/1b dose and schedule optimization study in subjects with advanced solid tumors.

    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-1495 and TPST-1120, antagonists of EP2/EP4 and PPARα, respectively. Both TPST-1495 and TPST-1120 are advancing through Phase 1 studies designed to study both agents as monotherapies and in combination with other approved agents. In collaboration with F. Hoffmann La Roche, TPST-1120 is also advancing through a first line, global, randomized Phase 1b/2 clinical study evaluating TPST-1120 in combination with the standard-of-care regimen of atezolizumab and bevacizumab in patients with advanced or metastatic hepatocellular carcinoma. Tempest is also developing an orally available inhibitor of TREX-1 designed to activate selectively the cGAS/STING pathway, an innate immune response pathway important for the development of anti-tumor immunity. 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"). 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, as well as assumptions made by, and information currently available to, management of Tempest. 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", "potentially," and other similar expressions. All statements that are not historical facts are forward-looking statements, including: any statements regarding the progress, scope or timing of the development and evaluation in clinical trials of our product candidates; or the benefits that may be derived from any future products. Forward-looking statements are based on information available to Tempest 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: our inability to successfully or timely develop our product candidates; our inability to realize any benefits from any future products; and our failure to realize any commercial or market benefit from future products, if any. These and other risks are described in greater detail in the Form 10-Q filed by Tempest with the Securities and Exchange Commission on November 10, 2021. Except as required by applicable law, Tempest 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's 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.

    Investor Contact:

    Sylvia Wheeler

    Wheelhouse Life Science Advisors

    Media Contact:

    Aljanae Reynolds

    Wheelhouse Life Science Advisors



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    • Data Reported at the 2021 Society for Immunotherapy of Cancer Annual Meeting

    SOUTH SAN FRANCISCO, Calif., Nov. 12, 2021 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (NASDAQ:TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, today reported in vitro and in vivo preclinical data demonstrating the potent dual mechanistic activity of TPST-1495, an orally-available small molecule designed to block the EP2 and EP4 receptors in the prostaglandin (PGE2) pathway. The data show that TPST-1495 effectively promotes anti-tumor activity through both T cell-dependent and -independent mechanisms. TPST-1495 is currently being evaluated in an ongoing Phase…

    • Data Reported at the 2021 Society for Immunotherapy of Cancer Annual Meeting

    SOUTH SAN FRANCISCO, Calif., Nov. 12, 2021 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (NASDAQ:TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, today reported in vitro and in vivo preclinical data demonstrating the potent dual mechanistic activity of TPST-1495, an orally-available small molecule designed to block the EP2 and EP4 receptors in the prostaglandin (PGE2) pathway. The data show that TPST-1495 effectively promotes anti-tumor activity through both T cell-dependent and -independent mechanisms. TPST-1495 is currently being evaluated in an ongoing Phase 1a/1b dose and schedule optimization trial in patients with solid tumors.

    "We're happy to present these data that build upon existing significant preclinical support for the hypothesis that selectively targeting the EP2 and EP4 receptors together, to the exclusion of EP1 and EP3, is the preferred approach to modulate the prostaglandin pathway for clinical benefit in cancer," said Tom Dubensky, president of Tempest. "We look forward to generating clinical data as TPST-1495 moves into a mechanism-based combination study with pembrolizumab this quarter, as well as into expansion studies in targeted patient populations in the first half of 2022."

    Presentation Highlights

    • TPST-1495 therapy promotes anti-tumor activity through both T cell-independent and T-cell dependent mechanisms, as evidenced by TME infiltration of effector immune cell populations and tumor antigen-specific CD8+ T cells
    • TPST-1495 therapy confers a significant survival advantage compared to therapy with single EP2 or EP4 antagonists, or the NSAID Celecoxib, in the APCmin/+ spontaneous tumor mouse model of CRC
    • TPST-1495 confers near complete restoration of immune function including activation of human antigen-specific CD8+ T cells in vitro, even in the presence of elevated PGE2 concentrations at which single EP4 or EP2 inhibitors are not effective
    • A summary of the near-term clinical development strategy that focuses on patients with histologies known to be prostaglandin-driven, as well as patients with the PIK3CA mutation, a potential biomarker.

    Presentation Information

    Saturday, November 13, 2021, Hall E, Poster #850

    About the PGE2 Pathway and TPST-1495

    Elevated expression of COX-2 and overproduction of PGE2 is correlated with progression of diverse malignancies by stimulating tumor cell proliferation via autocrine signaling through the EP2 and EP4 PGE2 receptors, which facilitates survival, evasion and metastasis. PGE2 also suppresses anti-tumor immunity by inhibiting the function of critical anti-tumor immune effector cell populations such as dendritic cells, macrophages, NK cells, and T cells. Recent studies have shown that increased expression of COX-2 and production of PGE2 may play a role in the effectiveness of immune checkpoint inhibitor ("ICI") therapy and in the development of adaptive immune resistance to ICI therapy.

    TPST-1495 is an orally available small molecule designed to block the EP2 and EP4 receptors in the prostaglandin (PGE2) pathway, while sparing the homologous but differentially active EP1 and EP3 receptors. PGE2 signaling through EP2 and EP4 has been observed both to enhance tumor progression and promote immune suppression. Tempest has conducted head-to-head preclinical studies comparing TPST-1495 to single antagonists of EP2 and EP4 and observed significantly enhanced activity of TPST-1495 in both overcoming PGE2-mediated suppression of human immune cells in vitro, as well as significantly increased anti-tumor activity in mouse models of human colorectal cancer. Tempest is currently evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and possible anti-tumor activity of TPST-1495 in a multicenter Phase 1a/1b dose and schedule optimization study in subjects with advanced solid tumors, with the potential to expand in indications known to be prostaglandin-driven, including colorectal cancer, or CRC, and in a tumor indication-agnostic, biomarker-selected cohort.

    About Tempest Therapeutics

    Tempest Therapeutics is a clinical-stage oncology company advancing small molecules that combine both targeted and immune-mediated mechanisms with the potential to treat a wide range of tumors. The company's two novel clinical programs are TPST-1495 and TPST-1120, antagonists of EP2/EP4 and PPARα, respectively. Both TPST-1495 and TPST-1120 are advancing through Phase 1 studies designed to study both agents as monotherapies and in combination with other approved agents. In collaboration with F. Hoffmann La Roche, TPST-1120 is also advancing through a first line, global, randomized Phase 1b/2 clinical study evaluating TPST-1120 in combination with the standard-of-care regimen of atezolizumab and bevacizumab in patients with advanced or metastatic hepatocellular carcinoma. Tempest is also developing an orally available inhibitor of TREX-1 designed to activate selectively the cGAS/STING pathway, an innate immune response pathway important for the development of anti-tumor immunity. 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"). 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, as well as assumptions made by, and information currently available to, management of Tempest. 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", "potentially," and other similar expressions. All statements that are not historical facts are forward-looking statements, including any statements regarding the progress, scope or timing of the development and evaluation in clinical trials of our product candidates or the benefits that may be derived from any future products. Forward-looking statements are based on information available to Tempest 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: our inability to successfully or timely develop our product candidates; our inability to realize any benefits from any future products; and our failure to realize any commercial or market benefit from future products, if any. These and other risks are described in greater detail in the Form 10-Q filed by Tempest with the Securities and Exchange Commission on November 11, 2021. Except as required by applicable law, Tempest 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's 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.

    Investor Contact:

    Sylvia Wheeler

    Wheelhouse Life Science Advisors

    Media Contact:

    Aljanae Reynolds

    Wheelhouse Life Science Advisors



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  1. BERKELEY, Calif., Nov. 11, 2021 /PRNewswire/ -- Actym Therapeutics, Inc. today announced the appointment of Chan Whiting, Ph.D. as Chief Development Officer. Chan brings over 20 years of drug development experience within the biotechnology industry. As CDO, Chan will play a key leadership role in advancing Actym's pipeline of first-in-class, systemically administered therapeutics that re-program the immunosuppressive microenvironment in solid tumors.  

    Actym Therapeutics hires Dr. Chan Whiting as Chief Development Officer.

    "Chan has significant experience advancing novel cancer therapies into clinical development," said Christopher Thanos, Ph.D., Chief Executive Officer of Actym Therapeutics. "Her product development experience will be instrumental in guiding Actym as we prepare to become a clinical stage company over the coming months."

    "Actym's novel S. Typhimurium-Attenuated Cancer Therapy (STACT) therapies have the unique ability to bring immunogenic payloads to the tumor microenvironment to promote potent and durable anti-tumor responses to tackle difficult to treat cancers.  I look forward to joining the team and helping guide the development of this entirely novel class of immunotherapies."

    Chan was previously Senior Vice President and Head of Research and Development at Tempest Therapeutics (NASDAQ:TPST). Before joining Tempest, Chan was Head of Immune Monitoring and Biomarker Development at Aduro Biotech.  Prior to Aduro, she has held multiple scientific leadership positions at Ingenuity ((currently Qiagen, NYSE:QGEN) and Entelos, Inc.  Chan received her Ph.D. in Microbiology and Immunology at UCLA and completed her postdoctoral studies at Tularik, Inc. (currently Amgen) and Stanford University. 

    About Actym

    Actym Therapeutics, based in Berkeley, CA, is a privately-held biotechnology company focused on discovery and development of novel immuno-oncology therapies to treat cancer. The company has developed an attenuated, microbial-based, immunotherapeutic technology platform called STACT (S. Typhimurium-Attenuated Cancer Therapy). In preclinical studies, STACT specifically enriches in many types of solid tumors and not in healthy tissue. Once there, STACT delivers multiplexed immuno-modulatory payloads directly to tumor-resident immune cells. Many of these payload targets are of significant interest to the biopharmaceutical community but are intractable using conventional approaches due to systemic toxicities after intravenous dosing. Furthermore, STACT has been engineered to deliver payload combinations, which facilitates engagement of multiple biological pathways from a single therapy. In April of 2020, Actym raised $34 million in a Series A financing, co-led by Boehringer-Ingelheim Venture Fund and Panacea Venture Healthcare, with participation from Illumina Ventures, Korea Investment Partners, and JLO Ventures.

    Media Contact:

    Valerie Enes

    Seismic Media Relations

    Corporate Contact:

    Sheriese Rush, MBA

    Head of Operations, Actym Therapeutics, Inc.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/actym-therapeutics-appoints-chan-whiting-as-chief-development-officer-301421766.html

    SOURCE Actym Therapeutics Inc.

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    • First patients dosed in first line, randomized, global Phase 1b/2 hepatocellular carcinoma ("HCC") study of TPST-1120 combination regimen, in collaboration with F. Hoffmann La Roche
    • Exclusive rights to novel oncology target in-licensed from the lab of Russell Vance, Ph.D., at the University of California at Berkeley ("U.C. Berkeley")

    SOUTH SAN FRANCISCO, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (NASDAQ:TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, today reported financial results and provided a corporate update for the third quarter ended September 30, 2021.

    "The third quarter of 2021 saw continued execution…

    • First patients dosed in first line, randomized, global Phase 1b/2 hepatocellular carcinoma ("HCC") study of TPST-1120 combination regimen, in collaboration with F. Hoffmann La Roche
    • Exclusive rights to novel oncology target in-licensed from the lab of Russell Vance, Ph.D., at the University of California at Berkeley ("U.C. Berkeley")

    SOUTH SAN FRANCISCO, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (NASDAQ:TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, today reported financial results and provided a corporate update for the third quarter ended September 30, 2021.

    "The third quarter of 2021 saw continued execution and progress in our programs, including the opening of a collaborative clinical trial with Roche in first line HCC patients comparing TPST-1120 in combination with atezolizumab and bevacizumab to the standard of care regimen, atezolizumab and bevacizumab," said Stephen R. Brady, chief executive officer of Tempest. "In the fourth quarter of this year and the first half of 2022, we plan to continue this focused approach as our second clinical program, TPST-1495, is poised to move into a set of studies that select patients predicated on strong mechanistic rationale, genetically-defined histologies, and a potential mutation-based biomarker."

    Recent Highlights

    • TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): continued enrollment in monotherapy dose optimization towards recommended Phase 2 dose ("RP2D").
    • TPST-1120 (clinical PPARα antagonist): (i) after completion of monotherapy dose escalation, continued enrollment in combination dose escalation towards RP2D; and (ii) commencement of first line, randomized global Phase 1b/2 study in HCC patients, under a collaboration with F. Hoffmann La Roche.
    • New Drug Discovery Program: entered into an exclusive license with U.C. Berkeley for intellectual property covering a new drug target discovered in the laboratory of Russell Vance, Ph.D., professor of molecular and cell biology at U.C. Berkeley and a Howard Hughes Medical Institute investigator.
    • Advisory Board: announced the appointment of Dr. Vance to Tempest's Advisory Board, joining a distinguished roster consisting of Toni Choueiri, M.D., Benjamin Cravatt, Ph.D., Raymond DuBois, M.D., Ph.D., Jason Luke, M.D., Drew Pardoll, M.D., and Peppi Prasit, Ph.D. 

    Planned Near-Term Milestones

    • TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) selection of monotherapy RP2D expected in the first half of 2022; (ii) commencement of a combination study with anti-PD-1 checkpoint inhibitor expected prior to the end of 2021; and (iii) commencement of monotherapy expansion in targeted indications and biomarker-selected patient populations expected in the first half of 2022.
    • TPST-1120 (clinical PPARα antagonist): (i) identification of RP2D of TPST-1120 in combination with nivolumab expected prior to the end of 2021; and (ii) presentation of Phase 1 monotherapy and combination data in mid 2022.
    • TREX-1 Inhibitor (preclinical tumor-selective STING pathway activator): planned selection of development candidate in the first half of 2022.

    Financial Results

    Third Quarter

    • Tempest ended the third quarter of 2021 with $59.8 million in cash and cash equivalents and short-term restricted cash, compared to $18.8 million in December 31, 2020. The increase was primarily due to the merger and concurrent PIPE, which closed in June 2021.
    • Net loss and net loss per share for the third quarter of 2021 were $8.1 million and $1.21, respectively, compared to $5.4 million and $11.22, respectively, for the third quarter of 2020. The increase was primarily due to an increase in compensation expense and professional fees associated with the merger.
    • Research and development expenses for the third quarter of 2021 were $4.6 million, compared to $4.3 million for the same period in 2020. The $0.3 million increase was primarily attributable to increased outside services, insurance and compensation expenses.
    • For the three months ended September 30, 2021, general and administrative expenses were $3.1 million compared to $1.2 million for the same period in 2020. The increase was primarily due to growth in compensation and rent expense, as well as professional fees associated with the merger.

    Year-to-Date

    • Net cash used in operations for the nine months ended September 30, 2021 was $18.0 million.
    • Net loss and net loss per share for the nine months ended September 30, 2021 were $20.5 million and $7.49, respectively, compared to $14.9 million and $31.91, respectively, for the same period in 2020.
    • Research and development expenses for the nine months ended September 30, 2021 were $12.5 million compared to $11.4 million for the same period in 2020. The $1.1 million increase was primarily due to increased compensation expenses and consulting services.
    • For the nine months ended September 30, 2021, general and administrative expenses were $7.2 million compared to $3.6 million for the same period in 2020.
    • Based on current cash position and operating plan, Tempest expects to have sufficient resources to fund operations into the second quarter of 2023.

    About Tempest Therapeutics

    Tempest Therapeutics is a clinical-stage oncology company advancing small molecules that combine both targeted and immune-mediated mechanisms with the potential to treat a wide range of tumors. The company's two novel clinical programs are TPST-1495 and TPST-1120, antagonists of EP2/EP4 and PPARα, respectively. Both TPST-1495 and TPST-1120 are advancing through Phase 1 studies designed to study both agents as monotherapies and in combination with other approved agents. In collaboration with F. Hoffman La Roche, TPST-1120 is also advancing through a first line, global, randomized Phase 1b/2 clinical study evaluating TPST-1120 in combination with the standard-of-care regimen of atezolizumab and bevacizumab in patients with advanced or metastatic hepatocellular carcinoma. Tempest is also developing an orally-available inhibitor of TREX-1 designed to activate selectively the cGAS/STING pathway, an innate immune response pathway important for the development of anti-tumor immunity. 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 10, 2021. 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, 2021 December 31, 2020
    Assets   
    Current assets   
    Cash and cash equivalents$59,761  $18,820 
    Prepaid expenses and other current assets 2,796   1,005 
    Total current assets 62,557   19,825 
        
    Property and equipment, net 1,116   1,110 
    Operating lease right-of-use assets 3,357   1,877 
    Other noncurrent assets 112   51 
        
    Total assets$67,142  $22,863 
        
    Liabilities and Stockholders' Equity (Deficit)   
    Current liabilities   
    Accounts payable$2,380  $1,071 
    Accrued expenses and other 2,323   1,439 
    Current operating lease liabilities 1,411   712 
    Interest payable 89   - 
    Total current liabilities 6,203   3,222 
        
    Loan payable, net 15,005   - 
    Operating lease liabilities 2,398   1,727 
    Total liabilities 23,606   4,949 
        
    Convertible preferred stock -   86,707 
        
    Stockholders' equity (deficit)   
    Common stock 7   15 
    Additional paid-in capital 135,902   2,953 
    Accumulated other comprehensive loss (89)  - 
    Accumulated deficit (92,284)  (71,761)
    Total stockholders' equity (deficit) 43,536   (68,793)
    Total liabilities, convertible preferred stock and stockholders' equity (deficit)$67,142  $22,863 
        



    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, 2021 September 30, 2020 September 30, 2021 September 30, 2020
    Expenses:       
    Research and development$4,630  $4,271  $12,451  $11,392 
    General and administrative 3,106   1,163   7,197   3,583 
            
    Total expenses 7,736   5,434   19,648   14,975 
            
    Operating loss (7,736)  (5,434)  (19,648)  (14,975)
            
    Other income (expense), net:       
    Interest expense (437)  -   (944)  - 
    Interest and other income, net 63   3   69   87 
            
    Net loss$(8,110) $(5,431) $(20,523) $(14,888)
    Net loss per share$(1.21) $(11.22) $(7.49) $(31.91)
            

    Investor Contacts:

    Sylvia Wheeler

    Wheelhouse Life Science Advisors

    Aljanae Reynolds

    Wheelhouse Life Science Advisors



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  2. SOUTH SAN FRANCISCO, Calif., Nov. 09, 2021 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (NASDAQ:TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, today announced that management will present at the following investor conferences in November:

    • Jefferies London Healthcare Conference – Company presentation available on-demand Thursday, November 18, 2021 at 8:00 a.m. GMT
    • Piper Sandler 33rd Annual Virtual Healthcare Conference – Fireside chat available on-demand Monday, November 22, 2021 at 10:00 a.m. ET

    To access the live or archived recording of the company presentaions, please visit the investor section of the Tempest website at https://ir.tempesttx.com

    SOUTH SAN FRANCISCO, Calif., Nov. 09, 2021 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (NASDAQ:TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, today announced that management will present at the following investor conferences in November:

    • Jefferies London Healthcare Conference – Company presentation available on-demand Thursday, November 18, 2021 at 8:00 a.m. GMT
    • Piper Sandler 33rd Annual Virtual Healthcare Conference – Fireside chat available on-demand Monday, November 22, 2021 at 10:00 a.m. ET

    To access the live or archived recording of the company presentaions, 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 targeted and immune-mediated mechanisms with the potential to treat a wide range of tumors. The company's two novel clinical programs are TPST-1495 and TPST-1120, antagonists of EP2/EP4 and PPARα, respectively. Both TPST-1495 and TPST-1120 are advancing through Phase 1 studies designed to study both agents as monotherapies and in combination with other approved agents. In collaboration with F. Hoffman La Roche, TPST-1120 is also advancing through a first line, global, randomized Phase 1b/2 clinical study evaluating TPST-1120 in combination with the standard-of-care regimen of atezolizumab and bevacizumab in patients with advanced or metastatic hepatocellular carcinoma. Tempest is also developing an orally-available inhibitor of TREX-1 designed to activate selectively the cGAS/STING pathway, an innate immune response pathway important for the development of anti-tumor immunity. Tempest is headquartered in South San Francisco. More information about Tempest can be found on the company's website at www.tempesttx.com.

    Investor Contact:

    Sylvia Wheeler

    Wheelhouse Life Science Advisors

    Media Contact:

    Aljanae Reynolds

    Wheelhouse Life Science Advisors



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