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Tempest Therapeutics Inc (TPST) is a clinical-stage biotechnology company pioneering small molecule therapies targeting cancer through immuno-oncology innovation. This page serves as the definitive source for verified news and official announcements related to TPST's research, clinical trials, and corporate developments.
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Bookmark this page for streamlined access to TPST's evolving story in cancer treatment innovation. Check regularly for authoritative reporting on developments impacting both patient care and investment considerations.
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.
Tempest Therapeutics (Nasdaq: TPST) reported Q2 2024 financial results and provided a business update. Key highlights include:
1. New positive survival data for amezalpat (TPST-1120) in first-line hepatocellular carcinoma (HCC) study, showing a six-month improvement in median survival over the control arm.
2. Plans to advance amezalpat towards a pivotal Phase 3 trial in first-line HCC.
3. Intention to move TPST-1495 into a Phase 2 study for Familial Adenomatous Polyposis (FAP).
4. Q2 2024 financial results: $31.1 million in cash and cash equivalents, net loss of $9.6 million, and net loss per share of $0.42.
5. Increased R&D expenses to $5.8 million and G&A expenses to $3.7 million for the quarter.
Tempest Therapeutics announced positive survival data from its Phase 1b/2 trial of amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab for treating unresectable or metastatic hepatocellular carcinoma (HCC). The trial showed a median overall survival (OS) of 21 months in the amezalpat arm versus 15 months in the control arm, marking a six-month improvement.
Key findings include a hazard ratio of 0.65, with 50% of patients in the amezalpat arm still in survival follow-up. The trial demonstrated a confirmed objective response rate (cORR) of 30% in the amezalpat arm compared to 13.3% in the control arm. Amezalpat was well tolerated, with a manageable safety profile.
The company will host a webcast conference call to discuss these results.
Tempest Therapeutics (Nasdaq: TPST) will release new data from its global randomized Phase 1b/2 study of amezalpat (TPST-1120), combined with atezolizumab and bevacizumab, in the first-line treatment of hepatocellular carcinoma (HCC). The announcement will be made in a premarket press release on June 20, 2024, followed by a webcasted conference call at 8:30 a.m. ET. The study aims to explore the efficacy and safety of this combination therapy in treating HCC. Participants can join the conference call by pre-registering online to receive the necessary telephone number and unique passcode. The live webcast and a 30-day audio replay will be available on the Tempest website.
Tempest Therapeutics (Nasdaq: TPST) announced on June 7, 2024, that its Compensation Committee has granted stock options to purchase 14,000 shares to an employee. This grant is under the company's 2023 Inducement Plan and is compliant with Nasdaq Listing Rule 5635(c)(4). The stock options will vest over four years, with 25% vesting after the first year and the remaining shares vesting monthly over the next three years, contingent upon continued employment.
Tempest Therapeutics (Nasdaq: TPST), a clinical-stage biotechnology company focused on developing targeted and immune-mediated cancer therapies, announced participation in two investor conferences.
Management will present at TD Cowen's 5th Annual Oncology Innovation Summit on May 29, 2024, at 2:00 p.m. ET and at the Jefferies Global Healthcare Conference on June 5, 2024, at 4:00 p.m. ET.
Recordings of these events will be available on the Tempest investor relations website.
Tempest Therapeutics, Inc. (Nasdaq: TPST) reported financial results for Q1 2024, advancing TPST-1120 and TPST-1495 in clinical trials. TPST-1120 showed positive preclinical and clinical data in kidney and liver cancers. TPST-1495 to enter Phase 2 for FAP. Financially, Tempest ended Q1 with $32.3 million in cash, with net loss of $7.9 million.
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