Investment reports

Tempest Reports First Quarter – GuruFocus.com

  • Announced Oral Presentation of TPST-1120 Phase 1 Monotherapy and Combination Therapy Data at ASCO
  • Presentation of Positive Preclinical Data for TPST-1495 at AACR
  • Presentation of Positive Preclinical Data with Proprietary Small Molecule TREX1 Inhibitors at AACR

SOUTH SAN FRANCISCO, Calif., May 13, 2022 (GLOBE NEWSWIRE) — Tempest Therapeutics, Inc. (TPST), a clinical-stage oncology company developing1 therapies that combine both targeted and immune-mediated mechanisms, today announced its financial results for the three months ended March 31, 2022 and provided a company update.

“The team continued to perform well throughout the first quarter of this year, allowing us to present early clinical data from a Tempest program at the ASCO annual meeting in June,” said Stephen R. Brady, CEO of Tempest. “We look forward to the next oral presentation, which will highlight the clinical profile and responses seen in the Phase 1 monotherapy and combination study of TPST-1120, our novel PPARa antagonist.”

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1 If FDA approved

Recent Highlights

  • TPST-1120 (clinical PPARα antagonist): (i) enrollment completed in the Phase 1 monotherapy and combination dose escalation arms; (ii) announced that the American Society of Clinical Oncology (ASCO) has accepted for oral presentation at its 2022 Annual Meeting an abstract containing TPST-1120 monotherapy and Phase 1 combination data; and (iii) continued enrollment in a global first-line randomized phase 1b/2 study in patients with hepatocellular carcinoma (HCC), as part of a collaboration with F. Hoffmann La Roche.
  • TPST-1495 (clinical dual antagonist of prostaglandin EP2/4 receptors): (i) continued enrollment in a phase 1 study evaluating both monotherapy and combination therapy (with the anti-PD-1 checkpoint inhibitor, pembrolizumab) dose and schedule optimization arm to establish RP2D; (ii) presented preclinical data further differentiating TPST-1495 from other approaches targeting the prostaglandin E2 (PGE2) pathway at the 2022 American Association for Cancer Research (AACR) Annual Meeting; and (ii) announced that ASCO has accepted for poster presentation an “ongoing trial” for the ongoing TPST-1495 Phase 1 monotherapy and combination therapy clinical trial.
  • TREX1 inhibitor (preclinical tumor-selective STING activator): presented early data with proprietary targeted molecules demonstrating therapeutic benefit in tumor-bearing mice at the 2022 AACR Annual Meeting.

Short-term planned milestones

  • TPST-1120 (clinical PPARα antagonist): (i) first presentation of clinical data from a Tempest program during the oral presentation of Phase 1 monotherapy and combination data at the 2022 ASCO Annual Meeting; and (ii) objective response data from the first 40 patients with HCC in the first-line randomized study expected by year-end or early 2023.
  • TPST-1495 (clinical antagonist of the dual prostaglandin EP2/4 receptor): (i) selection of RP2D monotherapy expected in the first half of 2022; (ii) presentation of the “trial in progress” poster at the 2022 ASCO annual meeting; and (iii) data from the phase 1 monotherapy and dose optimization and combination schedule arms expected by year-end or early 2023.
  • TREX1 inhibitor (selective preclinical tumor activator of the STING pathway): expected selection of the development candidate in the second half of 2022.

PIPE financing

  • On April 27, we announced a private investment of $15 million in public equity financing (PIPE) to EcoR1 Capital, LLC and Versant Venture Capital.

Financial results

first quarter

  • Tempest ended the first quarter of 2022 with $45.8 million in cash and cash equivalents, compared to $51.8 million as of December 31, 2021. The decrease is primarily due to cash used in operations of 7.1 million offset by proceeds from sales under our $1.4 ATM program. million. The cash balance does not reflect the $15 million raised in April through PIPE funding.
  • Net cash used in operations for the three months ended March 31, 2022 was $7.1 million, compared to $6.3 million for the same period in 2021.
  • Net loss and net loss per share for the three months ended March 31, 2022 were $8.5 million and $1.18, respectively, compared to $5.4 million and $10.55, respectively, for the first quarter of 2021.
  • Research and development expenses for the first quarter of 2022 were $5.1 million, compared to $3.6 million for the same period in 2021. The increase of $1.5 million is mainly attributable to increased research and development efforts and higher consulting fees and compensation expenses.
  • For the quarter ended March 31, 2022, general and administrative expenses were $3.0 million, compared to $1.5 million for the same period in 2021. The increase of $1.5 million s explained mainly by the increase in professional and consulting fees, insurance and compensation expenses.

About Tempest Therapeutics

Tempest Therapeutics is a clinical-stage oncology company developing 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 new clinical programs are TPST-1120 and TPST-1495, PPARα and EP2/EP4 antagonists, respectively. TPST-1120 and TPST-1495 are progressing in Phase 1 clinical trials designed to study both agents as monotherapy and in combination with other approved agents. In collaboration with F. Hoffmann La Roche, TPST-1120 is also progressing in a global Phase 1b/2 randomized clinical study in combination with standard treatment of atezolizumab and bevacizumab in the first-line treatment of patients with advanced hepatocellular carcinoma or metastatic. Tempest is also developing an orally available TREX-1 inhibitor designed to selectively activate the cGAS/STING pathway, an innate immune response pathway important for the development of anti-tumor immunity. Tempest is headquartered in South San Francisco. Additional information about Tempest is available 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”) )) regarding Tempest Therapeutics, Inc. (“Tempest Therapeutics”). These statements may discuss objectives, intentions and expectations with respect to future plans, trends, events, results of operations or financial condition, or otherwise, based on the current beliefs of the management of Tempest Therapeutics, as well as assumptions made by and information currently available to the management of Tempest Therapeutics. Forward-looking statements generally include statements that are predictive in nature and depend on or refer to future events or conditions, and include words such as “may”, “will”, “should”, “should”, “could”, “expects”, “anticipates”, “plans”, “likely”, “believes”, “estimates”, “projects”, “intends” 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 initiation or availability of clinical trial data, guidelines for the Company regarding cash resources, as well as our operational plans and timing and ability to meet 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 more detail in Form 10-K filed by Tempest Therapeutics with the Securities and Exchange Commission on March 29, 2022. Except as required by applicable law, Tempest Therapeutics does not assume any obligation to revise or update any forward-looking statements or make any other forward-looking statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be taken to represent the views of Tempest Therapeutics as of any date subsequent to the date of this press release and should not be relied upon as predictions of future events. In light of the foregoing, investors are cautioned not to rely on any forward-looking statements in drawing any conclusion or making an investment decision regarding Tempest Therapeutics securities.

TEMPEST THERAPEUTICS, INC.
Consolidated balance sheets
(in thousands)
March 31, 2022 December 31, 2021
Assets
Current assets
Cash and cash equivalents $ 45,754 $ 51,829
Legal settlement recovery insurance 15,000 15,000
Prepaid expenses and other current assets 1,956 2,134
Total current assets 62,710 68,963
Property and equipment, net 1,024 1,113
Operating lease right-of-use assets 2,739 3,051
Other non-current assets 480 111
Total assets $ 66,953 $ 73,238
Liabilities and equity (deficit)
Current liabilities
Accounts payable $ 684 $ 991
Legal settlement payable 15,000 15,000
Accruals and others 3,564 2,501
Current operating lease debts 1,473 1,442
Interest payable 94 92
Total current liabilities 20,815 20,026
Loan payable, net 15,133 15,069
Operating lease debts 1,648 2,026
Total responsibilities 37,596 37 121
Equity (deficit)
Ordinary actions seven seven
Premium 137,904 136 173
Accumulated deficit (108,554 ) (100,063 )
Total equity (deficit) 29,357 36 117
Total liabilities and equity (deficit) $ 66,953 $ 73,238
TEMPEST THERAPEUTICS, INC.
Consolidated Statements of Income
(in thousands except per share amounts)
Three months completed Three months completed
March 31, 2022 March 31, 2021
Expenses:
Research and development $ 5,109 $ 3,592
general and administrative 3,052 1,535
Total expenses 8,161 5,127
Operating loss (8,161 ) (5,127 )
Other income (expenses), net:
Interest expense (333 ) (231 )
Interest and other income, net 3 3
Net loss $ (8,491 ) $ (5,355 )
Net loss per share $ (1.18 ) $ (10:55 a.m. )

Investor contacts:
Sylvia Wheeler
Wheelhouse Life Science Advisors
[email protected]

Aljanae Reynolds
Wheelhouse Life Science Advisors
[email protected]

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