TPST

Strategic Alternatives Exploration: Tempest Therapeutics has engaged MTS Health Partners to explore strategic alternatives, including mergers and acquisitions or partnerships, to enhance its clinical programs and shareholder value amidst challenges in capital markets.

Market Response and Analyst Downgrades: Following the announcement, Tempest's stock fell nearly 7%, with analysts from Scotiabank and HC Wainwright downgrading the company due to concerns over partner interest and future growth potential.

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Amezalpat and TPST-1495 Developments: Tempest Therapeutics has received FDA and EMA approvals for Amezalpat (TPST-1120) to proceed with a Phase 3 trial in hepatocellular carcinoma, along with Orphan Drug and Fast Track designations. Additionally, the company has been cleared to start a Phase 2 trial for TPST-1495 targeting familial adenomatous polyposis.

Strategic Alternatives Exploration: The company is exploring various strategic alternatives, including potential mergers or partnerships, to enhance stockholder value and advance its clinical programs amid challenging capital market conditions.

Trading Halt: Tempest Therapeutics' trading has been halted pending news, indicating potential significant developments for the company.

FDA Designation and Price Target Changes: The company received FDA orphan designation for its treatment of FAP, but analysts have lowered their price targets significantly, reflecting ongoing financial challenges.

Analyst Rating: Matt Phipps from William Blair maintains a Buy rating on Tempest Therapeutics, despite the company's shares closing at $0.84 and an overall Hold consensus rating from analysts.

Financial Performance: Tempest Therapeutics reported a GAAP net loss of $10.56 million for the quarter ending September 30, which is an increase from a loss of $6.79 million in the same quarter last year.

Clinical Advancements: Tempest Therapeutics received both Orphan Drug and Fast Track designations from the FDA for Amezalpat (TPST-1120) aimed at treating Hepatocellular Carcinoma (HCC), and announced a partnership with Roche to advance this therapy into a pivotal Phase 3 trial. Additionally, they obtained FDA approval to proceed with a Phase 2 trial for TPST-1495 targeting Familial Adenomatous Polyposis (FAP).

Financial Overview: For the year ended 2024, Tempest reported a net loss of $41.8 million, an increase from the previous year, alongside a decrease in cash reserves from $39.2 million to $30.3 million, primarily due to operational expenses and investments in clinical trials.

David Sinclair's Aging Research: Harvard geneticist David Sinclair has promoted the idea that aging can be treated as a disease, leading to over $1 billion in investments for his companies.

Challenges in Longevity Drug Development: Despite significant funding, four companies have gone bankrupt or ceased operations, and others have not yet conducted effective human trials, raising doubts about the viability of their drugs.

FDA Approval and Roche Partnership: Tempest Therapeutics received FDA approval to proceed with a pivotal Phase 3 trial for amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab for treating first-line unresectable or metastatic hepatocellular carcinoma (HCC), alongside an agreement with Roche to support this advancement.

Financial Update and Leadership Expansion: The company reported a net loss of $10.6 million for Q3 2024, increased research and development expenses, and expanded its leadership team to enhance global clinical expertise.

Alphabet Inc. Financial Results: Alphabet Inc. shares rose 6% in pre-market trading after reporting third-quarter revenue of $88.27 billion, exceeding expectations and marking a 15% year-over-year increase.

Stock Movements: Several stocks experienced significant pre-market movements, with notable gainers including Haoxi Health Technology (up 82.8%) and NerdWallet (up 28.7%), while losers included O-I Glass (down 18.4%) and Qorvo (down 18%).

Stockholder Rights Plan Expansion: Tempest Therapeutics has decided to extend its stockholder rights plan until the Annual Meeting of Stockholders to help all investors realize long-term value and prevent control by any single entity through market accumulation.

Current Stock Performance: The company's stock is currently trading at $1.36, reflecting a 1.41 percent increase on the Nasdaq.

Tempest Therapeutics Agreement: Tempest Therapeutics Inc. is collaborating with Roche Holdings AG to advance the evaluation of amezalpat (TPST-1120) in a Phase 3 trial for first-line treatment of liver cancer, retaining all development and commercial rights to the drug.

Positive Clinical Data: Recent data from a Phase 1b/2 study showed significant improvements in median overall survival for patients receiving the combination therapy of amezalpat with standard treatments, leading to preparations for the upcoming Phase 3 study set to begin in early 2025.

Collaboration Announcement: Tempest Therapeutics has partnered with Roche Group to conduct a pivotal Phase 3 trial evaluating amezalpat in combination with atezolizumab and bevacizumab for treating unresectable or metastatic hepatocellular carcinoma (HCC).

Study Preparation: Roche will provide atezolizumab globally, while Tempest will lead the study, which is set to begin in the first quarter of 2025, following previous clinical collaborations between the two companies.

Collaboration Announcement: Tempest Therapeutics has partnered with Roche Group to conduct a pivotal Phase 3 trial evaluating amezalpat in combination with atezolizumab and bevacizumab for treating unresectable or metastatic hepatocellular carcinoma (HCC).

Study Preparation: The trial is set to begin in the first quarter of 2025, with Tempest leading the study while retaining all development and commercial rights to amezalpat.

Agreement with Roche: Tempest Therapeutics has partnered with Roche to advance the evaluation of amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab for the treatment of unresectable or metastatic hepatocellular carcinoma, moving into a pivotal Phase 3 trial after positive Phase 2 results.

Clinical Study Details: The planned Phase 3 study will compare the combination therapy against the standard care, with FDA agreement on the study design and statistical plan, aiming to start in Q1 2025.

Rights Plan Extension: Tempest Therapeutics has extended its limited duration stockholder rights plan until the 2025 Annual Meeting of Stockholders to protect against potential undervaluation and control threats, although it is not in response to any specific takeover threat.

Company Overview: Tempest Therapeutics is a clinical-stage biotechnology firm focused on developing innovative cancer therapies, with ongoing programs showing promising results and plans for further FDA engagement.

Stock Surge: Tempest Therapeutics' shares rose approximately 29% in pre-market trading following a partnership announcement with Roche to advance its lead asset, amezalpat (TPST-1120).

Collaboration Details: The agreement involves Roche supplying resources for the further development of Tempest's therapeutic candidate.

Stock Options Granted: Tempest Therapeutics announced the granting of nonqualified stock options for 79,500 shares to two employees, which will vest over four years based on continued employment.

Company Overview: Tempest Therapeutics is a biotechnology firm focused on developing innovative cancer treatments through targeted and immune-mediated therapies, with ongoing research and clinical studies.

Leadership Changes at Tempest Therapeutics: Tempest Therapeutics has appointed Sheldon Mullins as Vice President of Regulatory Affairs and Troy Wagner as Vice President of Quality Assurance, enhancing the company's leadership team as it prepares to advance its cancer treatment, amezalpat, into a pivotal study for first-line hepatocellular carcinoma patients.

Company Overview and Future Plans: Tempest Therapeutics is a clinical-stage biotechnology firm focused on developing innovative therapeutics for cancer, with a diverse portfolio aimed at treating various tumors, and is transitioning towards late-stage clinical development.

Stock Options Granted: Tempest Therapeutics announced the granting of nonqualified stock options for 60,000 shares to an employee, which will vest over four years based on continued employment.

Company Overview: Tempest Therapeutics is a biotechnology company focused on developing innovative cancer treatments through targeted and immune-mediated therapies, with ongoing research and clinical trials.