AUSTIN, Texas, May 13, 2019 (GLOBE NEWSWIRE) -- Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular” or “Molecular Templates”), a clinical-stage oncology company focused on the discovery and development of the company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics for cancer, today reported financial results for the first quarter of 2019. As of March 31, 2019, Molecular’s cash and investments totaled $84 million, and is expected to fund operations into the first half of 2021.
“So far in 2019, we have made substantial progress in advancing our pipeline and platform. We now have three Phase II studies open for our lead program, MT-3724, and our HER2 ETB, MT-5111, now has an open IND and Phase I dosing will begin in 3Q,” said Eric Poma, Ph.D., Molecular Templates’ Chief Executive and Scientific Officer. “At the recent American Association of Cancer Research (“AACR”) Annual Meeting, preclinical data was presented that showed that our second-generation ETBs utilizing our de-immunized scaffold have improved potency, greatly improved tolerability, and potential for less frequent dosing. These improvements have been demonstrated in preclinical studies with our ETBs targeting CD38, HER2, and PD-L1, all of which are expected to generate clinical data in the next 12 months.”
Company Highlights and Upcoming Milestones
- Molecular presented new data on its pipeline programs and technology platform in four posters at the AACR Annual Meeting 2019, March 29 - Apr 3, 2019 in Atlanta, Georgia. Presentations featured data on 1) CD38-targeted ETB TAK-169, 2) CD20-targeted ETB MT-3724 in combination with chemotherapy or IMiDs, 3) PD-L1-targeted ETB for direct cell kill approach to PD-L1 expressing cancers, 4) bispecific ETBs for targeted cancer treatment.
- Takeda and Molecular expect to file an IND and start a Phase I multiple myeloma trial in 2019 for TAK-169 (CD38 targeted ETB).
- Molecular is conducting a Phase II monotherapy study of MT-3724 in relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This study has the potential to be pivotal. Molecular expects to provide an update on this study in 2H19.
- Molecular is also conducting two Phase II studies in earlier lines of DLBCL; one with MT-3724 in combination chemotherapy (GemOx) and the other with MT-3724 in combination with Revlimid. Molecular expects to report an update on both MT-3724 combination studies with MT-3724 in 2H19.
- Molecular announced the acceptance of its IND filing for MT-5111, its ETB targeting HER2, in April 2019. The Phase I study in patients with HER2 positive solid tumors is expected to start dosing in 3Q19. Molecular expects to report an update on this study in 2H19.
- Molecular expects to file an IND application for MT-6035, its ETB targeting PD-L1 (with antigen seeding), in 2H19.
- Several other ETB candidates are in preclinical development, targeting both solid and hematological cancers.
Takeda Multi-Target Collaboration
- Takeda and Molecular are conducting lead optimization for ETBs against two undisclosed targets selected by Takeda under the collaboration. Should Takeda exercise its option to license ETBs for both targets, Molecular would receive $25 million and would be eligible to receive up to $547 million in milestone payments and tiered royalties on sales.
The net loss attributable to common shareholders for the first quarter of 2019 was $6.2 million, or $0.17 per basic and diluted share. This compares with a net loss attributable to common shareholders of $8.7 million, or $0.32 per basic and diluted share, for the same period in 2018.
Revenues for the first quarter of 2019 were $7.0 million, compared to $0.5 million for the same period in 2018. Revenues for the first 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 first quarter of 2019 were $8.5 million, compared with $6.7 million for the same period in 2018. Total general and administrative expenses for the first quarter of 2019 were $4.9 million, compared with $2.9 million for the same period in 2018.
About Molecular Templates
Molecular Templates is a clinical-stage oncology company focused on the discovery and development of differentiated, targeted, biologic therapeutics for cancer. We believe our proprietary biologic drug platform technology, referred to as engineered toxin bodies, or ETBs, provides a differentiated mechanism of action that may address some of the limitations associated with currently available cancer therapeutics. ETBs utilize a genetically engineered form of Shiga-like Toxin A subunit, or SLTA, a ribosome inactivating bacterial protein, that can be targeted to specifically destroy cancer cells. Additional information about Molecular Templates can be obtained at http://www.mtem.com.
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Molecular Templates disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Act’s Safe Harbor for forward-looking statements. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Molecular Templates may identify forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the development of the Company’s lead program, MT-3724; the expected timing of submitting various IND applications and conducting studies; and the Company’s belief that its proprietary biologic drug platform technology, or ETBs, provides for a differentiated mechanism of action that may address some of the limitations associated with currently available cancer therapeutics.
Forward-looking statements are not guarantees of future performance and involve risks and uncertainties. Actual events or results may differ materially from those discussed in the forward-looking statements as a result of various factors including, but not limited to, the uncertainties inherent in the preclinical and clinical development process; whether the Company’s cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; the ability of the Company to protect its intellectual property rights; and legislative, regulatory, political and economic developments, as well as those risks identified under the heading “Risk Factors” in the Company’s filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company specifically disclaims any obligation to update any forward-looking statement, whether because of new information, future events or otherwise.
Chief Financial Officer
|Molecular Templates, Inc.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except share and per share data)|
|Three Months Ended |
|Research and development revenue – from related party||$||6,413||$||163|
|Research and development revenue – other||—||68|
|Research and development||8,454||6,687|
|General and administrative||4,935||2,910|
|Total operating expenses||13,389||9,597|
|Loss from operations||6,381||9,115|
|Interest and other income, net||510||82|
|Interest and other expense, net||(293||)||(295||)|
|Change in fair value of warrant liabilities||(4||)||614|
|Net loss attributable to common shareholders||$||6,168||$||8,714|
|Net loss per share attributable to common shareholders:|
|Basic and diluted||$||0.17||$||0.32|
|Weighted average number of shares used in net loss per share calculations:|
|Basic and diluted||36,738,993||26,989,693|
|Molecular Templates, Inc.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|(in thousands, except share and per share data)|
|March 31, |
|December 31, |
|Cash and cash equivalents||$||37,855||$||87,721|
|Marketable Securities, Current||45,720||10,234|
|Accounts receivable from related party||295||240|
|Other current assets||5,085||4,424|
|Total current assets||90,960||104,863|
|Operating lease right-of-use assets, non-current||11,131||—|
|Property and equipment, net||7,108||6,851|
|In-process research and development||26,623||26,623|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Deferred revenue, current||19,307||26,231|
|Other current liabilities||1,232||141|
|Total current liabilities||28,100||32,509|
|Deferred revenue, long term||2,065||2,670|
|Long-term debt, net||3,159||3,254|
|Operating lease liabilities, long-term||10,770||—|
|Total stockholders’ equity||96,137||100,906|
|Total liabilities and stockholders’ equity||$||140,605||$||140,158|