On November 8, 2022 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, reported financial results for the quarter ended September 30, 2022 and provided a corporate update (Press release, Tempest Therapeutics, NOV 8, 2022, View Source [SID1234623376]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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 (Free SITC Whitepaper) 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) (Free SITC Whitepaper) 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 (Free SITC Whitepaper) 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.