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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 (Nasdaq: MTEM) announced a public offering of 6,000,000 shares at $12.65 per share, aiming to raise approximately $75.9 million in gross proceeds. The offering is expected to close around February 22, 2021, subject to customary conditions. The proceeds will fund Phase II clinical studies for MT-3724, ongoing studies for MT-5111, and development expenses in collaboration with Takeda, among other expenses. The underwriters have a 30-day option to purchase up to 900,000 additional shares.
Molecular Templates (MTEM) has initiated an underwritten public offering of its common stock, with the potential for underwriters to purchase an additional 15% of shares. The funds raised will support Phase II and Phase I clinical studies for its targeted cancer therapies, including MT-3724 and MT-5111, and development costs associated with collaborations, particularly with Takeda. The offering is contingent upon market conditions, and full details will be filed with the SEC.
Molecular Templates (Nasdaq: MTEM) has secured a $70 million upfront payment from Bristol Myers Squibb as part of a strategic research collaboration aimed at discovering and developing novel therapies for oncology targets. The collaboration will leverage MTEM's engineered toxin body (ETB) platform, which focuses on targeted cancer treatments. MTEM may also receive up to $1.3 billion in additional milestone payments, alongside tiered royalties on future sales, enhancing its financial outlook significantly.
Molecular Templates (Nasdaq: MTEM) announced that the FDA accepted its IND application for MT-6402, a next-generation engineered toxin body aimed at PD-L1-positive cancers. The company plans to initiate a Phase 1 study in relapsed/refractory patients with PD-L1-positive solid tumors in 2Q21. MT-6402 employs dual mechanisms to induce an immune response against tumors. The study will include dose escalation and expansion cohorts to evaluate the efficacy of MT-6402 as a monotherapy. Updates on the trial are expected by the end of 2021.
Molecular Templates (MTEM) announced progress in the Phase 1 study of MT5111, a HER2-targeted engineered toxin body (ETB), with 16 subjects treated and successful completion of five dosing cohorts. Pharmacokinetic data suggests that doses ≥5.0 μg/kg may be necessary for efficacy. No dose-limiting toxicities have been reported, and the most common adverse events were mild. The company plans to initiate a HER2 positive breast cancer expansion cohort in 1H21 at a dose of 10 μg/kg. The safety profile encourages further exploration of MT5111’s potential in overcoming resistance in HER2-positive cancers.
Molecular Templates (Nasdaq: MTEM) announced its participation in several upcoming healthcare conferences, including the Stifel 2020 Virtual Healthcare Conference and the Evercore ISI HealthCONx Conference. The Stifel conference will take place from November 16-18, with a presentation on November 17 at 9:20 am ET. The Evercore conference is scheduled for December 1-3, featuring a presentation on December 3 at 10:05 am ET. Live webcasts and presentations will be accessible through the company’s website.
Molecular Templates (Nasdaq: MTEM) reported its Q3 2020 financial results, highlighting a net loss of $23.2 million or $0.47 per share, improved from a loss of $38.2 million in Q3 2019. Revenues increased to $4.3 million, up from $3.6 million, driven by collaborative agreements. However, the FDA placed MT-3724 clinical studies on partial clinical hold after a treatment-related fatality due to capillary leak syndrome. Current patients can continue dosing, but no new enrollments will take place until the hold is lifted. Cash reserves of $118.2 million are projected to sustain operations into H2 2022.
Molecular Templates reported Q2 2020 financial results, showing a net loss of $31.2 million, or $0.68 per share, compared to a loss of $9.2 million in Q2 2019. Revenue increased to $6.9 million from $5.4 million year-over-year. The company secured a $45 million debt facility and raised $50 million via an ATM. Molecular Templates is advancing multiple ETB programs, with interim data expected in H2 2020 for MT-3724 and MT-5111. Challenges from COVID-19 have slowed patient enrollment in trials, but manufacturing operations remain uninterrupted.
Molecular Templates (Nasdaq: MTEM) announced a successful capital raise of approximately $43 million through its At-the-Market facility. The company sold around 3.6 million shares at $12.00 each, with the proceeds aimed at advancing its product pipeline, including MT-3724, MT-5111, TAK-169, and MT-6402. Cantor Fitzgerald & Co. served as the sales agent for this transaction. The shares were issued under an effective shelf registration statement filed previously.
Molecular Templates (MTEM) announced updates on its pipeline during the AACR Virtual Annual Meeting 2020. Four posters were presented, highlighting preclinical data on engineered toxin bodies (ETBs) targeting HER2-positive cancers, regulatory T cells, SLAMF7, and CD45. The Phase I study of MT-5111 shows promising results with no dose-limiting toxicities and well-tolerated treatment. MT-6402 is set for IND filing in the second half of 2020. A conference call discussing further details is scheduled for June 25, 2020.
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