8-K: Tempest Therapeutics Reports Positive Year-End 2023 Results and Advances Clinical Programs

Tempest Therapeutics announced positive clinical data for its lead drug candidate, TPST-1120, in liver cancer and provided a financial update for the year ended December 31, 2023.

Summary

• Tempest Therapeutics reported its financial results for the year ended December 31, 2023, and provided a business update.
• The company highlighted positive data from its TPST-1120 combination therapy in first-line liver cancer, showing superiority across multiple study endpoints compared to the standard of care.
• The data also showed positive effects in specific patient subpopulations, including those with PD-L1 negative and b-catenin mutations.
• Tempest is preparing to move TPST-1120 into a pivotal Phase 3 trial in liver cancer and TPST-1495 into a Phase 2 trial in Familial Adenomatous Polyposis (FAP).
• The company ended 2023 with $39.2 million in cash and cash equivalents, up from $31.2 million in 2022.
• The net loss for 2023 was $29.5 million, or $1.91 per share, compared to a net loss of $35.7 million, or $3.09 per share, in 2022.
• Research and development expenses decreased to $17.5 million in 2023 from $22.5 million in 2022.
• General and administrative expenses also decreased slightly to $11.7 million from $12.1 million in the previous year.
• Tempest expects to have sufficient resources to fund operations into the second quarter of 2025.

Sentiment

Score: 8

Explanation: The document presents very positive clinical data and a solid financial position, indicating a strong outlook for the company. The sentiment is optimistic due to the potential for TPST-1120 to become a new standard of care in liver cancer.

Positives

• The clinical data for TPST-1120 in liver cancer is very promising, showing significant improvements in response rates, progression-free survival, and overall survival compared to the standard of care.
• The company has a strong cash position of $39.2 million, which is expected to fund operations into the second quarter of 2025.
• The decrease in net loss and R&D expenses indicates improved financial management.
• The advancement of TPST-1120 into a Phase 3 trial and TPST-1495 into a Phase 2 trial are significant milestones for the company.
• The biomarker data supports the mechanism of action of TPST-1120 and its potential efficacy in specific patient populations.

Negatives

• The company is still operating at a loss, with a net loss of $29.5 million for 2023.
• The company is reliant on future funding to continue operations beyond the second quarter of 2025.
• The clinical trials are still ongoing, and there is no guarantee of regulatory approval for the drug candidates.

Risks

• The company's clinical trials may not be successful, and the drug candidates may not receive regulatory approval.
• The company may face unexpected safety or efficacy issues during clinical trials.
• The company may face competition from other companies developing similar therapies.
• Changes in the regulatory environment could impact the company's ability to bring its products to market.
• The company may need to raise additional capital in the future, which could dilute existing shareholders.

Future Outlook

Tempest expects to announce updated data from the ongoing randomized study in first-line liver cancer patients in 2024 and plans to advance TPST-1120 into a registrational study, subject to FDA feedback. They also plan to advance TPST-1495 into a Phase 2 study in FAP and expect to report data from the combination arm in endometrial cancer in 2024. The company expects to have sufficient resources to fund operations into the second quarter of 2025.

Management Comments

• Stephen Brady, president and chief executive officer of Tempest, stated that 2023 was a transformative year for Tempest.
• He also noted that the data from the TPST-1120 study showed the predicted positive effect in two subpopulations common in liver cancer and that they believe it sets up the program for a pivotal Phase 3 trial.
• He looks forward to 2024 as the year Tempest evolves towards becoming a late-stage clinical organization.

Industry Context

The announcement is significant in the oncology space, particularly in liver cancer treatment, where new therapies are needed. The positive results for TPST-1120 could position Tempest as a key player in this area. The advancement of TPST-1495 in FAP also addresses an unmet need in cancer prevention.

Comparison to Industry Standards

• The 30% confirmed objective response rate (cORR) for the TPST-1120 triplet arm is a significant improvement compared to the 13.3% cORR in the control arm, which is a standard of care regimen in first-line HCC. This suggests a potential for TPST-1120 to become a new standard of care.
• The median PFS of 7 months for the TPST-1120 arm compared to 4.27 months for the control arm is also a notable improvement, indicating a potential for longer disease control.
• The hazard ratios for PFS (0.7) and OS (0.59) favoring the TPST-1120 arm are clinically meaningful and suggest a significant survival benefit.
• Companies like Bristol Myers Squibb (Opdivo), Roche (Tecentriq), and Bayer (Nexavar) have established treatments in HCC, but the data from Tempest suggests a potential for TPST-1120 to offer a superior option, particularly in specific patient subpopulations.
• The advancement of TPST-1495 into a Phase 2 study in FAP is also noteworthy, as there are limited effective treatments for this condition. This positions Tempest to potentially address a significant unmet need.

Stakeholder Impact

• Shareholders are likely to react positively to the strong clinical data and improved financial position.
• Employees may be encouraged by the company's progress and future prospects.
• Patients with liver cancer and FAP may benefit from the development of new treatment options.
• The company's suppliers and partners may see increased business opportunities.

Next Steps

• Tempest plans to announce updated data from the ongoing randomized study in first-line liver cancer patients in 2024.
• The company plans to advance TPST-1120 into a registrational study in first-line liver cancer patients, subject to obtaining feedback from the FDA.
• Tempest plans to advance TPST-1495 into a Phase 2 study in patients with Familial Adenomatous Polyposis (FAP) in 2024, subject to final approval of NCI.
• The company expects to report data from the combination arm at the two highest TPST-1495 doses in patients with advanced endometrial cancer in 2024.

Key Dates

Keywords

Tempest Therapeutics, TPST-1120, TPST-1495, Hepatocellular Carcinoma, HCC, Liver Cancer, Familial Adenomatous Polyposis, FAP, Clinical Trial, Biomarker, Phase 3, Phase 2, PPAR antagonist, Prostaglandin receptor antagonist, Oncology, Cancer