On March 12, 2020 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of the Company’s proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported financial results for the fourth quarter of 2019 (Press release, Molecular Templates, MAR 12, 2020, View Source [SID1234555493]). As of December 31, 2019, MTEM’s cash and investments totaled $126.6 million, which is expected to fund operations into 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In 2019, we made important progress by advancing our pipeline programs, establishing a new collaboration outside of oncology with a premier partner, and strengthening our balance sheet with a successful equity financing," said Eric Poma, Ph.D., Molecular Templates’ Chief Executive and Scientific Officer. "We now have five ongoing studies across three clinical programs: three Phase 2 studies for MT-3724, a Phase 1 study for MT-5111, and a Phase 1 study with our partner Takeda for TAK-169. We also expect our earlier stage programs to advance in 2020, including an IND filing for MT-6402 (our PD-L1 ETB with antigen seeding), preclinical data presentations on ETBs against new targets, and continued progress in our multi-target collaborations with Takeda and Vertex."

Company Highlights and Upcoming Milestones

Corporate

On November 18, 2019, MTEM and Vertex Pharmaceuticals announced a strategic research collaboration to discover and develop novel targeted conditioning regimens that may enhance the hematopoietic stem cell transplant process, including transplants conducted as part of treatment with ex vivo CRISPR/Cas9 gene editing therapies such as CTX001. Under the collaboration, MTEM will conduct research activities for the use of ETBs for up to two targets selected by Vertex. The initial research will be focused on discovering a novel conditioning regimen using MTEM’s ETB technology platform. In addition, Vertex has an option to select a second target as part of the collaboration. Vertex made an up-front payment of $38 million to MTEM, including an equity investment. MTEM is also eligible to receive future development, regulatory and sales milestones and option payments of up to $522 million (across two targets) and tiered royalty payments on future sales.
On November 21, 2019, MTEM announced the pricing of an underwritten equity offering, the net proceeds of which were approximately $53.4 million, after deducting underwriting discounts and commissions and other estimated offering expenses payable by MTEM.
On February 19, 2020, MTEM announced the initiation of dosing in a Phase 1 study investigating TAK-169 in patients with relapsed/refractory multiple myeloma. Co-developed with Takeda Pharmaceutical Company Limited ("Takeda"), TAK-169 is a potential first-in-class CD38-targeting ETB. As a result of achieving this milestone, MTEM received a $10 million payment from Takeda.
MT-3724 (CD20 ETB)

At the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2019, MTEM presented the final results from the MT-3724 Phase 1/1b monotherapy study. The presentation included safety data on doses from 5-100 μg/kg, and efficacy data on 13 serum rituximab negative (RTX-neg) diffuse large B-cell lymphoma (DLBCL) or mixed DLBCL/FL subjects of whom 5 responded (38% objective response rate) across the range of 5 to 50 μg/kg doses. Of the 5 responses, 2 were complete responses (CRs) and 3 were partial responses (PRs). Three patients had stable disease (including 2 patients with 49% and 47% tumor reductions) and 5 patients had progressive disease. Of the 5 serum RTX-neg subjects with DLBCL who received MT-3724 at 50 μg/kg, the maximum tolerated dose (MTD), 3 responded (2 CRs, 1 PR).
MTEM is currently conducting three ongoing Phase 2 studies in relapsed/refractory DLBCL: a monotherapy study that has the potential to be pivotal, a combination study with chemotherapy, and a combination study with lenalidomide.
In January 2020, MTEM reported that the combination study with lenalidomide has demonstrated preliminary evidence of tolerability and efficacy with lenalidomide at standard doses and MT-3724 at 10 μg/kg. MT-3724 dosing at higher doses with lenalidomide is ongoing.
In January 2020, MTEM reported that the combination study with GemOx has demonstrated preliminary evidence of efficacy but Grade 2 innate immune adverse effects were seen with standard doses of gemcitabine and oxaliplatin and 10 μg/kg doses of MT-3724. The study protocol has been amended to include a revised schedule in which MT-3724 dosing is initially sequenced with GemOx dosing.
MTEM expects to report updates on all three MT-3724 studies throughout 2020.
TAK-169 (CD38 ETB)

Takeda and MTEM are currently conducting a Phase 1 study for TAK-169 in relapsed/refractory multiple myeloma.
In December 2019, TAK-169 received Orphan Drug Designation from the FDA.
MT-5111 (HER2 ETB)

In December 2019, MTEM presented preclinical data on MT-5111 at the San Antonio Breast Cancer Symposium (SABCS).
The Phase 1 study of MT-5111 in HER2-positive cancers is ongoing with multiple sites open for enrollment.
MTEM expects to announce interim clinical results from the MT-5111 Phase 1 study in 2Q20 and additional data from the dose escalation portion of the study in 4Q20.
Research

MTEM expects to file an IND application for MT-6402, its ETB targeting PD-L1 (with antigen seeding), in 2H20.
Several other ETB candidates are in preclinical development against targets including CTLA-4, SLAMF-7, and CD45.
In 2020, MTEM expects to present preclinical data on new targets and new ETBs at conferences.
Financial Results

The net loss attributable to common shareholders for the fourth quarter of 2019 was $15.9 million, or $0.41 per basic and diluted share. This compares with a net loss attributable to common shareholders of $6.6 million, or $0.18 per basic and diluted share, for the same period in 2018.

Revenues for the fourth quarter of 2019 were $6.2 million, compared to $4.7 million for the same period in 2018. Revenues for the fourth quarter of 2019 were comprised of revenues from collaborative research and development agreements with Takeda, and grant revenue from CPRIT. Total research and development expenses for the fourth quarter of 2019 were $16.6 million, compared with $7.6 million for the same period in 2018. Total general and administrative expenses for the fourth quarter of 2019 were $6.0 million, compared with $3.9 million for the same period in 2018.