Tempest Announces Q2 2024 Financial Results and Business Update

Tempest Therapeutics, a clinical-stage biotechnology company, has unveiled promising new data for its experimental drug amezalpat (TPST-1120), which shows a significant survival benefit in patients with hepatocellular carcinoma (HCC). The company reported a six-month improvement in median overall survival (OS) for patients treated with amezalpat combined with atezolizumab and bevacizumab, compared to those receiving the latter two drugs alone.

Stephen Brady, president and CEO of Tempest, emphasized the importance of these findings. "Improving survival for liver cancer patients with an appropriate safety profile is our goal," he said. He noted that the six-month survival improvement and strong hazard ratio bolster confidence in amezalpat's potential success.

The new data come from a global randomized Phase 1b/2 clinical study involving 70 patients. Among them, 40 were treated with the combination including amezalpat, and 30 were in the control group. The median OS was 21 months for the amezalpat group, compared to 15 months for the control. Currently, 20 out of 40 patients in the amezalpat group continue in survival follow-up, as opposed to 9 out of 30 in the control group. The hazard ratio for OS stood at 0.65, consistent with earlier analysis.

In addition to the survival benefits, amezalpat demonstrated a manageable safety profile. This aligns with earlier Phase 1 data, suggesting the treatment's safety and efficacy. The drug also showed promise in preclinical studies for kidney cancer, both alone and in combination with standard therapies.

The publication of positive data in the Journal of Cancer Research Communications further supports amezalpat's potential. In early-phase trials, the drug showed clinical activity, including tumor shrinkage, even in cancers resistant to PD-1 inhibitors. This complements the earlier positive findings from a randomized global study of the drug in combination with atezolizumab and bevacizumab.

Moving forward, Tempest plans to advance amezalpat into a pivotal Phase 3 trial for first-line HCC patients, pending feedback from the FDA. The company also has plans for TPST-1495, another of its clinical-stage drugs. TPST-1495 is set to enter a Phase 2 study for patients with Familial Adenomatous Polyposis (FAP) in 2024, under the Cancer Prevention Clinical Trials Network, funded by the National Cancer Institute.

Financially, Tempest reported a net loss of $9.6 million for the second quarter of 2024, up from $7.6 million in the same period of 2023. This increase is attributed to higher research and development expenses, primarily from contract research and manufacturing costs, as well as stock-based compensation. General and administrative expenses also saw a rise due to increased stock-based compensation and legal and consulting services.

For the first half of 2024, Tempest's net loss was $17.5 million, compared to $15.2 million in the same period in 2023. The company's cash and cash equivalents stood at $31.1 million at the end of June 2024, down from $39.2 million at the end of 2023. Research and development expenses for the first half of the year were $10.2 million, an increase from $9.1 million in the same period in 2023. Administrative expenses also rose to $7.4 million from $6.0 million in the first half of 2023.

Tempest Therapeutics continues to make strides in its mission to develop targeted and immune-mediated therapies for cancer. With promising data for amezalpat and plans to advance other drug candidates, the company remains committed to improving outcomes for cancer patients.