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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) announced a partial clinical hold on its Phase 1 study of MT-0169 due to cardiac adverse events observed at a higher dosage of 50 mcg/kg. The FDA is reviewing safety data from lower doses (5 mcg/kg and 10 mcg/kg) where no cardiac events were reported among eight patients. The hold permits current participants to continue treatment, but new enrollments are paused. Notably, one patient at 5 mcg/kg showed a Very Good Partial Response evolving into a stringent complete response. The FDA has requested additional data to evaluate the benefit-to-risk ratio of the lower doses before lifting the hold, as patient safety remains a priority for MTEM.
Molecular Templates (Nasdaq: MTEM) announced a strategic reprioritization focusing on the clinical development of MT-6402, MT-8421, and MT-0169, alongside a workforce reduction of approximately 50%. This restructuring aims to extend the company’s financial runway and halt the MT-5111 clinical program. MTEM reported a net loss of $22 million for Q4 2022, with revenues falling to $2.6 million compared to $18 million in Q4 2021. The total research and development costs were $17.6 million, showing a slight decrease from the previous year. As of December 31, 2022, the company had $61 million in cash and investments, with expectations for a runway until Q2 2024.
Molecular Templates, Inc. (MTEM) announced FDA clearance to proceed with clinical testing of its MT-8421 engineered toxin body program, targeting CTLA-4 in patients with relapsed/refractory solid tumors. MT-8421 aims to eliminate CTLA-4-expressing Tregs in the tumor microenvironment, offering a novel approach compared to traditional monoclonal antibodies. Preclinical data indicated effective depletion of immune-suppressive Tregs without affecting peripheral Tregs, and MT-8421 exhibited good tolerance in non-human primate studies. The company plans to initiate a Phase I study by mid-2023.
Molecular Templates, Inc. (Nasdaq: MTEM), a clinical-stage biopharmaceutical company, is set to participate in three key healthcare conferences in March 2023. The Cowen Annual Health Care Conference will feature a panel on breast and lung cancer on March 7, while the Oppenheimer Healthcare Conference will host a fireside chat on March 15. Additionally, one-on-one meetings will occur at the Barclays Global HealthCare Conference from March 14-16. These events will showcase Molecular Templates' focus on targeted biologic therapeutics and engineered toxin bodies (ETBs) for cancer treatment.
Molecular Templates (Nasdaq: MTEM) announced its participation in the upcoming 45th Annual San Antonio Breast Cancer Symposium (SABCS) and the 64th American Society of Hematology (ASH) Annual Meeting. They will present a poster on interim clinical results for the MT-5111 program at SABCS, scheduled for December 7, 2022, at the Henry B. Gonzalez Convention Center. Additionally, one-on-one meetings will be conducted at the ASH meeting from December 10-13, 2022, in New Orleans, LA. These events highlight the company's focus on developing targeted biologic therapeutics through engineered toxin bodies.
Molecular Templates, Inc. (Nasdaq: MTEM) announced CEO Eric Poma, Ph.D., will participate in two upcoming conferences from November 29 to December 1, 2022. The first event is a virtual fireside chat at Evercore ISI’s 5th Annual HealthCONx conference on November 30 at 9:15 AM ET, focusing on positive data regarding next-generation engineered toxin bodies (ETBs). The second is an in-person chat at Piper Sandler’s 34th Annual Healthcare Conference on December 1 at 3:00 PM ET in New York. Attendees can access both events via registration links provided by the company.
Molecular Templates (MTEM) reported Q3 2022 financial results, showing a net loss of $24.6 million ($0.44 per share) compared to $30.4 million ($0.54 per share) in Q3 2021. Revenues increased to $4.2 million from $2.4 million year-over-year, primarily from collaboration with Bristol Myers Squibb. The company continues to advance clinical trials for its programs MT-6402, MT-5111, and MT-0169, achieving notable results such as tumor regression in patients with NSCLC and promising responses in HER2-positive breast cancer cases.
Molecular Templates (Nasdaq: MTEM) announced its participation in the Society for Immunotherapy of Cancer’s 37th Annual Meeting from November 8-12, 2022, in Boston. The company will present four abstracts on engineered toxin bodies (ETBs), including interim data on MT-6402 and MT-8421. A Research & Development Day is scheduled for November 11, 2022, featuring presentations from senior leadership and a live Q&A session. Eric Poma, CEO, emphasized the differentiated approach of MTEM in immuno-oncology.
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