Tempest Therapeutics, Inc. develops clinical-stage cell therapy and small-molecule product candidates for cancer and related disease areas. News about TPST centers on its dual-targeting CAR-T platform, including TPST-2003, a CD19/BCMA CAR-T therapy under development for relapsed or refractory multiple myeloma, and clinical updates from programs such as REDEEM-1 and POEMS-1.
Company updates also cover CAR-T manufacturing and technology-transfer work, partner-supported development activities, business development and licensing priorities, and the amezalpat small-molecule program. Recurring corporate news includes financial results, pipeline portfolio changes following acquired CAR-T assets, leadership appointments, and governance or capital-structure matters tied to the company’s Nasdaq-listed common stock.
Tempest Therapeutics (NASDAQ: TPST) reported Q3 2024 financial results and key developments. The company received FDA's 'Study May Proceed' letter for a pivotal Phase 3 trial of amezalpat combination therapy for first-line HCC treatment. Tempest announced an agreement with Roche to support amezalpat's advancement and received NCI funding approval for TPST-1495 Phase 2 trial in FAP.
Financial highlights include: Q3 cash position of $22.1M, net loss of $10.6M ($0.41 per share), and R&D expenses of $7.6M. The company raised additional $19.9M through ATM offering post-quarter. Year-to-date operating cash burn was $22.9M with a net loss of $28.0M ($1.19 per share).
Tempest Therapeutics (Nasdaq: TPST) announced receiving a 'Study May Proceed' letter from the FDA for a pivotal Phase 3 trial of amezalpat (TPST-1120) combined with atezolizumab and bevacizumab. This trial will compare this combination against the current standard of care alone in treating first-line unresectable or metastatic hepatocellular carcinoma (HCC). Chief Medical Officer Sam Whiting highlighted the potential of amezalpat to improve patient survival, citing positive Phase 2 data. The company aims to advance this program to benefit patients with this life-threatening disease.
Tempest Therapeutics (Nasdaq: TPST) has announced an agreement with Roche to advance amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab into a pivotal Phase 3 trial for first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC). The study is set to begin in Q1 2025. This follows positive Phase 2 data showing a six-month improvement in median overall survival for the combination therapy compared to the control arm.
Key points:
- Roche will supply atezolizumab globally, while Tempest sponsors and leads the pivotal study
- Tempest retains all development and commercial rights to amezalpat
- FDA agreed on the Phase 3 study plan, including primary endpoint and statistical plan
- A pre-specified early efficacy analysis could potentially shorten the study's timeline by 8 months
Tempest Therapeutics (Nasdaq: TPST) has announced an extension to its duration stockholder rights plan. The Board of Directors adopted this amendment to extend the plan's duration until the Annual Meeting of Stockholders. The decision comes after significant milestones in the amezalpat program, including positive survival data compared to standard of care and FDA agreement on the Phase 3 path.
The Rights Plan aims to protect stockholders' long-term value and reduce the likelihood of control gain through open market accumulation without appropriate premiums. It will automatically expire after the 2025 Annual Meeting unless approved by stockholders. The plan becomes exercisable if an entity acquires 10% or more of Tempest's outstanding common stock (15% for certain passive institutional investors).
Tempest Therapeutics (Nasdaq: TPST), a clinical-stage biotechnology company focused on developing targeted and immune-mediated cancer therapeutics, has announced the granting of stock options to two employees. The Compensation Committee of the company's Board of Directors approved nonqualified stock options for the purchase of 79,500 shares of common stock under Tempest's 2023 Inducement Plan.
The stock options have a four-year vesting period, with 25% vesting on the first anniversary of each employee's start date, followed by 1/48th of the total shares vesting monthly thereafter. The vesting is subject to continued employment on each vesting date. This announcement is made in accordance with Nasdaq Listing Rule 5635(c)(4), which pertains to inducement grants for new employees.
Tempest Therapeutics (Nasdaq: TPST) has appointed Sheldon Mullins as Vice President of Regulatory Affairs, strengthening its leadership team as it prepares for the pivotal study of amezalpat in first-line hepatocellular carcinoma (HCC). This appointment follows the recent addition of Troy Wagner as VP of Quality Assurance, both bringing late-stage development expertise to the company.
The company has also updated titles for Darrin Bomba and Henry Johnson to reflect their roles in late-stage development. CEO Stephen Brady emphasized the importance of expanding the team's global clinical capabilities as Tempest transitions to a late clinical company. Mullins brings over 25 years of regulatory affairs experience, spanning pre-IND to post-approval activities across various therapeutic areas.
Tempest Therapeutics (Nasdaq: TPST), a clinical-stage biotech company focused on developing targeted and immune-mediated cancer therapies, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. Dr. Sam Whiting, the company's chief medical officer and head of R&D, will deliver a presentation that will be available for on-demand viewing starting September 9, 2024, at 7:00 a.m. ET.
Investors and interested parties can access the presentation through the investor section of Tempest's website. This event provides an opportunity for Tempest to showcase its innovative approach to cancer treatment and potentially attract investor interest in its clinical-stage pipeline.
Tempest Therapeutics (Nasdaq: TPST), a clinical-stage biotechnology company focused on developing targeted and immune-mediated cancer therapeutics, has announced an inducement grant under Nasdaq Listing Rule 5635(c)(4). The company's Compensation Committee granted one employee nonqualified stock options to purchase 60,000 shares of common stock under Tempest's 2023 Inducement Plan.
The stock options have a four-year vesting period, with 25% vesting on the first anniversary of the employee's start date, followed by 1/48th of the total shares vesting monthly thereafter. This vesting schedule is subject to continued employment on each vesting date.
Tempest Therapeutics (Nasdaq: TPST) has appointed Troy M. Wagner as Vice President of Quality Assurance. This move aims to strengthen the company's global clinical expertise as it progresses towards Phase 3 development of amezalpat, its lead oncology candidate for treating hepatocellular carcinoma (liver cancer). Wagner brings over 30 years of experience in quality and clinical compliance, having previously held leadership positions at Tricida, Jubilant Life Sciences, Alcon, and other pharmaceutical companies. Her expertise in late-stage product development, global clinical studies, and regulatory filings is expected to contribute significantly to Tempest's goal of bringing amezalpat to patients.
Tempest Therapeutics (Nasdaq: TPST) announced a successful end-of-Phase 2 meeting with the FDA for amezalpat (TPST-1120) in treating first-line hepatocellular carcinoma (HCC). The FDA and Tempest reached broad agreement on the pivotal Phase 3 study plan, including:
1. Using the current amezalpat dose and schedule
2. Setting overall survival as the primary endpoint
3. Implementing an early efficacy analysis that could significantly reduce time to primary read-out
The planned Phase 3 study closely mirrors the randomized Phase 2 study, which showed a strongly favorable hazard ratio for overall survival. This outcome gives Tempest confidence in the potential success of the Phase 3 trial for amezalpat in combination with atezolizumab and bevacizumab for first-line unresectable or metastatic HCC.