On November 15, 2021 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported financial results for the third quarter of 2021 (Press release, Molecular Templates, NOV 15, 2021, View Source [SID1234595621]).
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"We are focused on execution across our growing portfolio of wholly owned next-generation ETBs," said Eric Poma, Ph.D., Molecular Templates’ Chief Executive and Scientific Officer. "Third quarter highlights included the initiation of clinical development of MT-6402 (targeting PD-L1 via dual mechanisms), the initiation of the HER2-positive breast cancer expansion cohort for MT-5111 as well as continued enrollment of patients in our MT-0169 clinical program. These programs demonstrate the depth and versatility of our ETB platform and the potential to develop innovative treatments for a broad array of solid and hematological tumors with high unmet medical need."
Company Highlights and Upcoming Milestones
Corporate
In July 2021, MTEM dosed its first subject in a Phase 1 study of MT-6402. MT-6402 is the first of MTEM’s 3rd generation ETBs incorporating Antigen Seeding Technology to enter the clinic and represents a new approach to immuno-oncology.
On August 4, 2021, MTEM assumed full rights to TAK-169, now known as MT-0169, from its former co-development partner, Takeda, including full control of MT-0169 clinical development.
Enrollment in the MT-0169 Phase 1 study in relapsed/refractory multiple myeloma has resumed after the transfer of the IND to MTEM.
MTEM expects to provide an update on MT-5111, MT-0169 and MT-6402 by the end of this year and expects to provide periodic updates throughout 2022.
MT-0169 (CD38 ETB)
On August 4, 2021, MTEM assumed full rights to MT-0169 from its former co-development partner, Takeda, including full control of MT-0169 clinical development, per the terms of the terminated collaboration agreement with Takeda. MTEM will continue conducting the ongoing Phase 1 study for MT-0169 in relapsed/refractory multiple myeloma and non-Hodgkin’s lymphoma.
Patient enrollment in the 50 mcg/kg cohort is currently ongoing. MTEM continues to see pharmacodynamic activity with MT-0169. Data on the first four patients treated in the Phase 1 study evaluating MT-0169 was presented in a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting on November 12.
MT-6402 (PD-L1 ETB with Antigen Seeding Technology)
MTEM is enrolling patients in the Phase 1 study of MT-6402 which initiated in July 2021. MT-6402 is the first of MTEM’s 3rd generation ETBs to enter the clinic. It was designed to induce potent anti-tumor effects via PD-L1 targeting through multiple mechanisms that may overcome the limitations of PD-L1 antibody therapies.
The Phase 1 study is a multi-center, open-label, dose escalation and dose expansion trial in the United States. Patients with confirmed PD-L1 expressing tumors or confirmed PD-L1 expression in the tumor microenvironment are eligible for enrollment.
Patient enrollment in the 16 mcg/kg cohort (the starting dose) is currently ongoing. There have been no dose limiting toxicities and no signs of capillary leak syndrome observed to date.
Following determination of the maximum tolerated dose (MTD) or recommended Phase 2 dose, expansion cohorts are planned to evaluate MT-6402 as a monotherapy in tumor-specific and tumor-agnostic cohorts.
MT-5111 (HER2 ETB)
The Phase 1 study of MT-5111 in HER2-positive cancers is ongoing with multiple sites open for enrollment.
The HER2-positive breast cancer expansion cohort initiated as of November 2021 at a dose of 10 mcg/kg (anticipated to be a therapeutic dose level). Dose escalation will continue to determine the recommended Phase 2 dose while the breast cancer expansion cohort collects efficacy and safety data.
Research
MTEM continues to advance its pipeline of next-generation ETBs targeting CTLA-4, TIGIT, TROP2, SLAMF-7, CD20, and CD45.
A poster on ETB mediated depletion of TIGIT expressing immune cells for cancer immunotherapy was presented at the SITC (Free SITC Whitepaper) annual meeting on November 13.
Through 2021 and in 2022, MTEM expects to present preclinical data on ETB candidates at medical and scientific conferences.
Upcoming Investor Events
Stifel Healthcare Conference (November 15-17, 2021)
Evercore ISI 4th Annual HealthCONx (November 30 – December 2, 2021)
Financial Results
The net loss attributable to common shareholders for the third quarter of 2021 was $30.4 million, or $0.54 per basic and diluted share. This compares with a net loss attributable to common shareholders of $23.2 million, or $0.47 per basic and diluted share, for the same period in 2020.
Revenues for the third quarter of 2021 were $2.4 million, compared to $4.3 million for the same period in 2020. Revenues for the third quarter of 2021 were comprised of revenues from collaborative research and development agreements with Vertex and Bristol Myers Squibb. Total research and development expenses for the third quarter of 2021 were $22.9 million, compared with $19.6 million for the same period in 2020. Total general and administrative expenses for the third quarter of 2021 were $9.0 million, compared with $7.5 million for the same period in 2020.
As of September 30, 2021, MTEM’s cash and investments totaled $175.4 million. MTEM’s current cash and investments are expected to fund operations into the second half of 2023.