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Molecular Templates, Inc. (Nasdaq: MTEM) is a clinical-stage biopharmaceutical company dedicated to the discovery and development of targeted therapeutics for oncology. The company leverages its innovative proprietary platform, engineered toxin bodies (ETBs), which are designed to selectively target and kill tumor cells, offering a novel approach to cancer treatment.
MTEM's leading immunotoxin, MT-3724, is in clinical development for non-Hodgkin's lymphoma. In addition to MT-3724, the company's robust pipeline includes MT-6402, targeting PD-L1, and MT-8421, targeting CTLA-4, both aimed at different forms of cancer. MT-0169, another advanced candidate, targets CD38 and is being developed for potential use in various oncology indications.
Recently, MTEM announced significant progress in its clinical trials. The first patient has been dosed in a Phase 1 clinical trial of MT-8421 for the treatment of advanced solid tumors. This study is a multi-center, open-label, dose-escalation trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of MT-8421. The trial will enroll patients with tumors where CTLA-4 inhibitors have shown benefits, including melanoma, hepatocellular carcinoma, non-small cell lung cancer, and others.
MT-6402, another promising candidate, has shown encouraging results in Phase 1 studies, particularly in heavily pre-treated head and neck cancer patients. The drug demonstrated objective responses and evidence of tumor regression in patients who had progressed on multiple lines of treatment.
Financially, MTEM reported third-quarter 2023 revenues of $6.8 million, reflecting a notable increase from the previous year, driven primarily by collaborative research and development agreements. However, the company continues to operate at a net loss, with efforts focused on reducing operational costs and extending its cash runway into the second quarter of 2024.
Molecular Templates (MTEM) has received notice from Nasdaq's Listing Qualifications Department regarding its imminent delisting. The notification, received on December 16, 2024, cites multiple compliance failures: the company has been deemed a 'public shell', failed to file its Q3 2024 10-Q report, and failed to maintain the required $1.00 minimum bid price.
Trading of MTEM's common stock will be suspended on December 26, 2024. The company has decided not to appeal the delisting decision through a Nasdaq Hearings Panel hearing. Nasdaq will proceed with filing Form 25-NSE with the SEC to formally delist MTEM's securities.
Molecular Templates (MTEM) has received two deficiency notifications from Nasdaq. The first notice, received on November 25, 2024, concerns non-compliance with listing rules due to delayed filing of Q3 2024 Form 10-Q. MTEM has until January 24, 2025, to submit a compliance plan. The second notice addresses failure to maintain the minimum $1.00 bid price requirement. The company has until May 26, 2025, to regain compliance by maintaining a closing bid price above $1.00 for at least 10 consecutive business days. If the stock price falls below $0.10, Nasdaq may issue a delisting determination. Currently, these notices don't affect MTEM's listing status on Nasdaq Capital Market.
Molecular Templates (MTEM) reported Q2 2024 financial results and corporate updates. Key highlights include:
1. Continued monotherapy activity in MT-6402 (PD-L1 ETB) program, with durable responses in heavily pretreated patients.
2. Early indication of monotherapy activity in MT-8421 (CTLA-4 ETB) program.
3. Exploring MT-0169's potential in severe autoimmune diseases.
Financial results: Q2 2024 net loss of $8.1 million ($1.23 per share), compared to $10.9 million ($2.89 per share) in Q2 2023. Revenues decreased to $0.6 million from $6.9 million year-over-year. Cash and equivalents totaled $9.7 million as of June 30, 2024, expected to support operations into Q4 2024.
Molecular Templates provided an interim update on its clinical-stage programs focusing on its ETB (Engineered Toxin Bodies) platform. Key highlights include:
MT-6402 (PD-L1-targeting ETB): This drug has shown promising results in heavily pre-treated solid tumor patients, especially those with low PD-L1 expression. Noteworthy outcomes include partial responses in head and neck cancer patients and an unconfirmed partial response in a non-small cell lung cancer patient. The safety profile of MT-6402 remains favorable.
MT-0169 (CD38-targeting ETB): This drug demonstrates strong potential in treating immune-mediated diseases by effectively depleting CD38+ immune cells. It displayed potent activity in pre-clinical and early clinical data, with no grade 3 or higher adverse events reported.
MT-8421 (CTLA-4 ETB): Early Phase 1 data show promising pharmacodynamic effects with no severe drug-related adverse events, although one patient experienced disease progression.
The company emphasizes the potential of its ETB platform across multiple diseases and continues to enroll patients in its ongoing studies.
Molecular Templates (Nasdaq: MTEM) reported its first-quarter 2024 financial results. The company presented promising clinical data for MT-6402 at the AACR Annual Meeting, showing a tolerable safety profile and efficacy in relapsed/refractory HNSCC patients. Financially, MTEM had a net income of $0.6M, or $0.11 per basic share, a significant drop from $10.8M in the same period last year. Revenue declined to $11.1M from $36.6M. R&D expenses decreased to $7.4M from $19.0M, and G&A expenses fell to $3.7M from $5.8M. Cash and cash equivalents were $6.8M as of March 31, 2024. The company completed a $9.5M financing in April and expects to sustain operations into Q4 2024.
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