Tempest Therapeutics is a clinical-stage biotechnology company at the forefront of developing first-in-class targeted and immune-mediated cancer therapeutics. With a diverse pipeline of promising product candidates, the company is steadfastly navigating the dynamic landscape of oncology drug development, driven by its commitment to improving patient outcomes.
Business Overview and History
Tempest Therapeutics was founded in 2019 with the vision of leveraging cutting-edge scientific discoveries to create transformative cancer treatments. The company's initial focus was on two lead product candidates - amezalpat (previously known as TPST-1120) and TPST-1495. In January 2021, Tempest entered into a loan agreement with Oxford Finance LLC, providing the company with up to $35 million in borrowing capacity across three potential tranches. The initial tranche of $15 million was funded at the closing of the loan agreement.
Over the next few years, Tempest made significant progress advancing its product candidates through clinical trials. In 2022, the company presented data from the Phase 1 trials of both amezalpat and TPST-1495 at medical conferences. The data showed promising signs of activity and tolerability for both product candidates in patients with advanced solid tumors. In 2023, Tempest faced some challenges when it merged with Millendo Therapeutics, Inc. This merger allowed Tempest to expand its pipeline and expertise, but also resulted in the company needing to navigate the integration of the two organizations. Despite these challenges, Tempest was able to continue advancing its clinical programs and strengthening its leadership team to support the company's future development efforts.
The company's lead product candidate, amezalpat (previously known as TPST-1120), is a selective antagonist of the peroxisome proliferator-activated receptor alpha (PPARα) and is currently being evaluated in a pivotal Phase 3 clinical trial for the treatment of first-line unresectable or metastatic hepatocellular carcinoma (HCC). Tempest's second clinical-stage asset, TPST-1495, is a dual antagonist of the EP2 and EP4 receptors of prostaglandin E2 and is progressing into a Phase 2 study in familial adenomatous polyposis (FAP).
Tempest's pipeline also includes several earlier-stage programs targeting a variety of cancer indications, showcasing the breadth and depth of the company's research and development efforts. The company's commitment to innovation is further demonstrated by its collaborative partnerships, such as the recent agreement with Roche to support the advancement of amezalpat into a pivotal Phase 3 trial.
Financial Performance and Liquidity
As a clinical-stage biotechnology company, Tempest Therapeutics has not yet generated any revenue from product sales. The company's financial performance has been characterized by ongoing research and development expenses, which amounted to $17.5 million and $22.5 million in 2023 and 2022, respectively. Similarly, the company's general and administrative expenses were $11.7 million and $12.1 million for the same periods.
Tempest's net loss for 2023 and 2022 was $29.5 million and $35.7 million, respectively. The company's cash and cash equivalents as of December 31, 2023, stood at $39.2 million, providing a solid foundation to support its ongoing and future clinical development efforts.
In the third quarter of 2024, Tempest reported a net loss of $10.6 million, compared to a net loss of $6.8 million in the same period of the previous year. The company's cash and cash equivalents as of September 30, 2024, were $22.1 million, which management believes will be sufficient to fund its operations through at least the next 12 months.
To bolster its financial resources, Tempest has utilized an at-the-market (ATM) offering program, raising $8.3 million in net proceeds as of September 30, 2024. The company has also secured a loan agreement with Oxford Finance, which provided an initial tranche of $15 million, of which $5 million was repaid in 2022.
For the most recent fiscal year (2023), Tempest reported no revenue, a net loss of $29,491,000, operating cash flow (OCF) of -$27,357,000, and free cash flow (FCF) of -$27,527,000. In the most recent quarter (Q3 2024), the company reported no revenue, a net loss of $10,556,000, OCF of $12,696,000, and FCF of $12,681,000.
As of September 30, 2024, Tempest's debt-to-equity ratio stood at 0.7736, with $10.7 million outstanding from its $35 million loan agreement with Oxford Finance. The company's current ratio and quick ratio were both 1.6855, indicating a relatively stable short-term liquidity position. The loan agreement contains financial covenants and other restrictions that Tempest must adhere to.
Between October 1, 2024, and November 8, 2024, Tempest raised an additional $19.9 million in net proceeds through its ATM offering program, further strengthening its financial position.
Regulatory Milestones and Clinical Progress
Tempest's lead candidate, amezalpat, has made significant strides in its clinical development. In August 2024, the company announced the successful completion of its end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), receiving positive feedback on the pivotal Phase 3 clinical trial design. The planned Phase 3 trial will evaluate amezalpat in combination with atezolizumab and bevacizumab, the current standard of care, versus the standard of care alone in patients with first-line unresectable or metastatic HCC.
Additionally, Tempest recently announced an agreement with Roche to support the advancement of amezalpat into the pivotal Phase 3 trial. Under the agreement, Roche will supply atezolizumab, free of charge, for use in the study. In October 2024, the company entered into a master clinical supply agreement with Roche to formalize this arrangement.
As of an updated February 14, 2024 data cut, the ongoing global randomized Phase 1b/2 trial of amezalpat combined with the standard-of-care first-line regimen of atezolizumab and bevacizumab continued to show positive outcomes in patients with advanced or metastatic HCC. The median Overall Survival (OS) in the amezalpat arm reached 21 months, representing a 6-month improvement over the 15-month OS in the control arm. The confirmed objective response rate (ORR) for the amezalpat arm remained consistent at 30%, compared to 13.3% in the control arm.
Regarding Tempest's second clinical-stage asset, TPST-1495, the company has received final funding approval from the National Cancer Institute (NCI) to move the drug candidate into a Phase 2 trial for the treatment of FAP, a rare genetic condition that predisposes individuals to the development of colorectal polyps and cancer. Data from the TPST-1495 Phase 1 trial was presented at the American Society of Clinical Oncology (ASCO) annual meeting in June 2023, supporting the advancement of this candidate into new indications.
Tempest has also strengthened its leadership team to support the advancement of its clinical programs. In September 2024, the company appointed Sheldon Mullins as Vice President of Regulatory Affairs, further bolstering its regulatory expertise.
Risks and Challenges
As a clinical-stage biotechnology company, Tempest Therapeutics faces several risks and challenges inherent to the industry. The successful development and commercialization of its product candidates are subject to the inherent uncertainties of the drug development process, including the risk of failure in clinical trials, regulatory approval hurdles, and the potential for adverse events or safety concerns.
Additionally, Tempest's reliance on third-party contract research organizations (CROs) and contract manufacturing organizations (CMOs) for the conduct of its clinical trials and the production of its drug candidates introduces operational and supply chain risks that could impact the company's progress.
The highly competitive nature of the oncology therapeutics market also presents a significant challenge, as Tempest's products will need to demonstrate superior efficacy and safety profiles to compete with established and emerging therapies.
Furthermore, Tempest's financial position as a clinical-stage company without any approved products or revenue streams exposes it to the ongoing need for capital and the risk of being unable to secure sufficient funding to support its operations and development activities.
Conclusion
Tempest Therapeutics is at the forefront of innovative cancer therapy development, with a diverse pipeline of promising product candidates and a track record of clinical and regulatory achievements. The company's lead asset, amezalpat, is poised to enter a pivotal Phase 3 trial for the treatment of first-line HCC, while its second clinical-stage candidate, TPST-1495, is progressing into a Phase 2 study for FAP.
Tempest's commitment to scientific excellence, strategic partnerships, and strengthening of its leadership team position the company well to navigate the challenges of the dynamic oncology landscape and drive meaningful advancements in the treatment of cancer. As the company continues to execute on its clinical development plans and explore new avenues of research, investors will closely monitor Tempest's progress and ability to deliver on its promise of bringing novel therapies to patients in need.
The company's financial performance, while characterized by ongoing losses typical of clinical-stage biotechnology firms, shows a focused approach to resource management and capital raising. With a strengthened cash position and strategic collaborations in place, Tempest appears well-positioned to support its ongoing clinical trials and advance its pipeline candidates through critical development milestones in the coming years.