Molecular Templates Announces Q2 2024 Financial Results and Update

Molecular Templates, Inc. (MTEM), a clinical-stage biopharmaceutical company, has reported its financial results and business updates for the second quarter of 2024. The company's focus is on developing proprietary targeted biologic therapeutics, known as Engineered Toxin Bodies (ETBs), which aim to create novel therapies with potent and differentiated mechanisms of action.

According to Eric Poma, PhD, Chief Executive and Chief Scientific Officer of MTEM, ETBs represent a novel approach to immuno-oncology. They can eliminate immune cells that monoclonal antibodies cannot, potentially leading to durable responses in patients who have progressed or are refractory to checkpoint therapy. Specifically, the elimination of immunosuppressive cells in patients with tumor microenvironments that enable immune evasion could result in long-lasting responses. Poma highlighted the potential of MT-0169 to eliminate CD38+ immune cells, which antibodies cannot, possibly offering greater potency in both hematologic malignancies and autoimmune diseases.

Recent highlights from MTEM's development programs include ongoing research into MT-6402, MT-8421, and MT-0169.

For MT-6402, a phase I dose escalation study is investigating its effectiveness in patients who have progressed or been refractory to checkpoint therapy. Nine patients with low PD-L1+ Head and Neck Squamous Cell Carcinoma (HNSCC) have been dosed, with two patients showing partial responses lasting up to over 23 cycles. In a high PD-L1+ dose expansion cohort, one out of four enrolled Non-Small Cell Lung Cancer (NSCLC) patients has also shown a partial response after progressing on other therapies. All responding patients had undergone three or more previous lines of treatment, indicating MT-6402's potential in heavily pretreated patients. The study continues to enroll HNSCC patients with low PD-L1 expression and those with solid tumors exhibiting high PD-L1 expression.

MT-8421's Phase 1 dose escalation study is ongoing, with five evaluable melanoma patients showing promising early results. No drug-related adverse events greater than grade 2 have been observed. Notably, one patient, who had previously progressed on pembrolizumab and ipilimumab, remains in the study with a significant reduction in tumor volume and circulating tumor DNA. This patient also exhibited a substantial decrease in peripheral and tumor microenvironment Tregs, pointing to the drug's unique pharmacodynamic profile and potential monotherapy activity.

For MT-0169, there is exploration into its use for severe autoimmune diseases based on its ability to completely eliminate CD38+ immune cells without significant adverse events. Its unique mechanism of action, not subject to resistance mechanisms associated with monoclonal antibodies, allows for the elimination of both high and low-expressing CD38+ cells. MTEM will continue developing MT-0169 for hematologic malignancies and is evaluating its potential in severe immune-mediated diseases.

Looking ahead to the second half of 2024, MTEM anticipates additional updates from the MT-6402 and MT-8421 studies, as well as the initiation of Phase 1 studies for MT-0169 in CD38+ hematological malignancies and autoimmune diseases. The company will also participate in the H.C. Wainwright 26th Annual Global Investment Conference in September.

Financially, the second quarter saw MTEM with a net loss attributable to common shareholders of $8.1 million, a decrease from the $10.9 million loss in the same period of 2023. Revenues for the quarter were $0.6 million, down from $6.9 million the previous year. Research and development expenses also declined significantly to $5.4 million from $13.4 million in 2023. General and administrative expenses dropped to $3.5 million from $5.2 million. As of June 30, 2024, the company had cash and cash equivalents totaling $9.7 million, expected to sustain ongoing operations into the fourth quarter of 2024.

Molecular Templates continues to focus on advancing its ETB platform to develop next-generation therapies for cancer and other diseases, leveraging its unique biological mechanisms to address unmet medical needs.