On August 8, 2024 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, reported financial results for the quarter ended June 30, 2024, and provided a corporate update (Press release, Tempest Therapeutics, AUG 8, 2024, View Source [SID1234645626]).

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"During the second quarter, amezalpat demonstrated positive survival benefit as a potential treatment for first-line liver cancer patients," said Stephen Brady, president and chief executive officer of Tempest. "Improving survival for these patients with the right safety profile is our goal and is also the primary global regulatory endpoint for this indication. This remarkable six-month improvement in survival compared to the standard of care, and maintenance of a strong hazard ratio, gives us confidence in the potential success of the program. These data point to the potential of amezalpat to help HCC patients in a meaningful way, and we’re excited to be moving the program towards a pivotal study."

Recent Highlights

Amezalpat (TPST-1120) (clinical PPARα antagonist):
Reported new positive survival data from the ongoing global randomized Phase 1b/2 clinical study demonstrating amezalpat (TPST-1120) delivered a six-month improvement in median overall survival ("OS") when combined with atezolizumab and bevacizumab in comparison to atezolizumab and bevacizumab alone in the first-line treatment of patients with unresectable or metastatic HCC. At the cutoff date of February 14, 2024, the new data from 40 patients randomized to the amezalpat arm and 30 patients randomized to the control arm showed:
21-month median OS for the amezalpat arm versus 15 month for the control arm, a six-month survival advantage
20/40 patients remain in survival follow up in the amezalpat arm, compared to 9/30 patients in the control arm
The survival benefit was maintained across key subpopulations
0.65 hazard ratio ("HR") for OS, revealing a stable HR since the top-line analysis 10 months earlier when the HR was 0.59
Manageable safety profile consistent with Phase 1 data
Reported new preclinical data at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrating that amezalpat reduces kidney cancer growth as a monotherapy, while also showing increased inhibition when combined with frontline chemotherapy and immunotherapy. These data further support the clinical benefit observed in the TPST-1120 Phase 1 data presented in an oral presentation at ASCO (Free ASCO Whitepaper) 2022.
Published positive data from Phase 1 Trial of amezalpat in patients with advanced solid tumors in the Journal of Cancer Research Communications. Data showed that amezalpat demonstrated clinical activity, including tumor shrinkage, even in PD-1 inhibitor-refractory and immune-compromised cancers, and was well tolerated both as monotherapy and in combination with nivolumab. These data complement the positive Phase 1b/2 data reported in October 2023 from a global randomized study of amezalpat in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC.
Potential Future Milestones

Amezalpat (TPST-1120) (clinical PPARα antagonist)
Plan to advance amezalpat into a registrational Phase 3 study in first-line HCC patients, subject to obtaining feedback from the FDA.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist)
Plan to advance TPST-1495 into a Phase 2 study in patients with Familial Adenomatous Polyposis ("FAP") in 2024 under the auspices of the Cancer Prevention Clinical Trials Network and funded by the National Cancer Institute ("NCI") Division of Cancer Prevention, subject to final approval of NCI.
Expect to report data from the combination arm at the two highest TPST-1495 doses in patients with advanced endometrial cancer, where prostaglandin signaling is implicated, in 2024.
Financial Results

Second Quarter 2024

Tempest ended the quarter with $31.1 million in cash and cash equivalents, compared to $39.2 million on December 31, 2023.
Net loss and net loss per share for the quarter ended June 30, 2024, were $9.6 million and $0.42, respectively, compared to $7.6 million and $0.54, respectively, for the same period in 2023.
Research and development expenses for the quarter were $5.8 million compared to $4.4 million for the same period in 2023. The $1.4 million increase was primarily due to an increase in costs incurred from contract research and manufacturing organizations, as well as stock-based compensation.
General and administrative expenses for the quarter were $3.7 million compared to $3.1 million for the same period in 2023. The $0.6 million increase was primarily due to an increase in stock-based compensation expense as well as legal and consulting services.
Year-to-Date

Cash used in operating activities for the six months ended June 30, 2024 was $12.7 million.
Net loss and net loss per share for the six months ended June 30, 2024 were $17.5 million and $0.78, respectively, compared to $15.2 million and $1.09, respectively, for the same period in 2023.
Research and development expenses for the six months ended June 30, 2024 were $10.2 million compared to $9.1 million for the same period in 2023. The $1.1 million increase was primarily due to an increase in costs incurred from contract research and manufacturing organizations, as well as stock-based compensation.
General and administrative expenses for the six months ended June 30, 2024 were $7.4 million compared to $6.0 million for the same period in 2023. The $1.4 million increase was primarily due to an increase in stock-based compensation expense as well as legal and consulting services.