On May 13, 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 first quarter of 2021 (Press release, Molecular Templates, MAY 13, 2021, View Source [SID1234579935]).
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"We are focused on advancing our wholly owned pipeline of next-generation ETBs and our existing partnerships following the assumption of full rights to TAK-169 from Takeda and the discontinuation of the MT-3724 program," said Eric Poma, Ph.D., Molecular Templates’ Chief Executive and Scientific Officer. "Over the remainder of 2021, we expect to generate clinical data from MT-5111, TAK-169, and MT-6402 and advance our earlier stage programs."
Company Highlights and Upcoming Milestones
Corporate
On February 11, 2021, MTEM and Bristol Myers Squibb announced a strategic research collaboration to discover and develop multiple novel therapies designed for specific oncology targets. Under the collaboration, MTEM will conduct research activities for the discovery of next generation ETBs for multiple targets, of which the first target has been selected by Bristol Myers Squibb. Bristol Myers Squibb made an up-front payment of $70 million to MTEM and MTEM is also eligible to receive near-term and development, regulatory and sales milestone payments of up to approximately $1.3 billion as well as tiered royalty payments on future sales.
On February 18, 2021, MTEM announced the pricing of an underwritten public equity offering, the gross proceeds of which were approximately $75.9 million.
On April 5, 2021, MTEM announced that following discussion with its co-development partner Takeda, MTEM will assume full rights to TAK-169 including taking control of clinical development from Takeda. In addition, MTEM announced the decision to discontinue development of MT-3724, MTEM’s only first-generation ETB. MTEM will focus on the clinical development of next-generation ETBs MT-5111, TAK-169, and MT-6402, as well as advancing next-generation preclinical ETB candidates against targets including CTLA-4, CD20, SLAMF-7, CD45 and TROP2.
MTEM had three presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, which took place virtually from April 10-15, 2021:
MT-5111 (interim Phase 1 data as of December 2020), abstract CT130, titled "Phase 1 study of the novel immunotoxin MT-5111 in patients with HER-2+tumors."
MT-6402 (preclinical data), abstract 1628, titled "Engineered toxin bodies targeting PD-L1 to alter tumor immunophenotypes and deliver broad antigenic diversity and patient coverage."
CTLA-4 ETB (preclinical data), abstract 1627, titled "Preclinical characterization of a novel CTLA-4-targeted ETB for direct Treg depletion."
MT-5111 (HER2 ETB)
The Phase 1 study of MT-5111 in HER2-positive cancers is ongoing with multiple sites open for enrollment.
In December 2020, MTEM provided an update on the ongoing Phase 1 study, details of which were presented at AACR (Free AACR Whitepaper) in April. No dose limiting toxicities were observed in any cohort and no signs of cardiotoxicity have been observed to date, while monitoring the subjects’ EKGs, troponin values and pro-BNP with each treatment, and serial echocardiograms with every other cycle. No cases of capillary leak syndrome, or CLS, (any grade) were observed.
The HER2-positive breast cancer expansion cohort is planned to begin in 3Q21 at a dose of 10 mcg/kg (anticipated to be a therapeutic dose level), pending adequate safety data. Dose escalation will continue to determine the recommended Phase 2 dose while the breast cancer expansion cohort collects efficacy and safety data.
MTEM expects to provide an update on additional data from both the dose escalation portion of the study and the metastatic breast cancer dose expansion cohort in 4Q21.
TAK-169 (CD38 ETB)
As announced on April 5, 2021, MTEM will assume full rights to TAK-169 including taking control of clinical development from Takeda. MTEM will continue conducting the ongoing Phase 1 study for TAK-169 in relapsed/refractory multiple myeloma. This study, which started dosing in February 2020, had a temporary pause in the activation of new study sites and new patient enrollment (along with most of Takeda’s other early-stage studies) due to COVID-19 and was re-initiated in 4Q20.
MTEM expects to provide an update on the Phase 1 study in 4Q21.
MT-6402 (PD-L1 ETB with antigen seeding)
On January 19, 2021, MTEM announced that the U.S. Food and Drug Administration (FDA) accepted its Investigational New Drug (IND) application for MT-6402.
MTEM expects to start dosing in a first-in-human Phase 1 study in relapsed/refractory patients with PD-L1-positive solid tumors in 2Q21. The Phase 1 study is planned as a multi-center, open-label, dose escalation and dose expansion trial. Patients with confirmed PD-L1 expressing tumors or confirmed PD-L1 expression in the tumor microenvironment will be eligible to screen for enrollment in the clinical trial. Following determination of the maximum tolerated dose (MTD) or recommended Phase 2 dose, expansion cohorts are planned to study MT-6402 as a monotherapy in tumor-specific and tumor-agnostic cohorts.
MTEM expects to provide an update on the Phase 1 study in 4Q21.
Research
MTEM expects to initiate a Phase 1 study for an ETB targeting CTLA-4 in 2022.
Several other wholly owned ETB candidates are in preclinical development against targets including CD20, SLAMF-7, CD45, and TROP2.
In 2021, MTEM expects to present preclinical data on new targets and new ETBs at medical and scientific conferences.
Financial Results
The net loss attributable to common shareholders for the first quarter of 2021 was $26.8 million, or $0.51 per basic and diluted share. This compares with a net loss attributable to common shareholders of $22.0 million, or $0.48 per basic and diluted share, for the same period in 2020.
Revenues for the first quarter of 2021 were $3.2 million, compared to $4.1 million for the same period in 2020. Revenues for the first quarter of 2021 were comprised of revenues from collaborative research and development agreements with Takeda, Vertex and Bristol Myers Squibb. Total research and development expenses for the first quarter of 2021 were $21.4 million, compared with $20.6 million for the same period in 2020. Total general and administrative expenses for the first quarter of 2021 were $8.2 million, compared with $5.6 million for the same period in 2020.
As of March 31, 2021, MTEM’s cash and investments totaled $207.4 million. MTEM’s current cash and investments are expected to fund operations into the second half of 2023.