Molecular Templates, Inc. Reports First Quarter 2020 Financial Results
“We continue to make meaningful progress at MTEM despite the headwinds that COVID-19 has created for clinical trial site initiation and patient enrollment,” said
Company Highlights, Pipeline Status, and Upcoming Milestones
February 19, 2020, MTEM announced the initiation of dosing in a Phase I study investigating TAK-169 in patients with relapsed/refractory multiple myeloma. Co-developed with Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of 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 millionpayment from Takeda.
Impact of COVID-19
- The COVID-19 pandemic has resulted in a significant slowdown in the pace of site initiations and patient enrollment across our MT-3724 Phase II programs. As a CD20-targeting agent for the treatment of hematological malignancy, MT-3724 may impair the ability to generate humoral immunity to coronavirus infection. Physicians may be less inclined to enroll patients given this concern.
- MT-5111 screening and enrollment has been less impacted than MT-3724 but is still enrolling at a slower pace than was projected pre-COVID-19.
- To date, MTEM has been able to continue to work at its cGMP manufacturing facility and laboratories without interruption from COVID-19. As a result, manufacturing of product supply for clinical trials and research activities to support advancement of our preclinical pipeline (including partnered programs) have not been impacted to date by COVID-19.
- During the COVID-19 pandemic, MTEM is carefully and continually evaluating the potential individual patient risk associated with continuing to enroll in MTEM’s existing studies and the degree of disruption to these studies and MTEM’s business generally.
MT-3724 (CD20 ETB)
- MTEM is currently conducting three ongoing Phase II studies in relapsed/refractory diffuse large B-cell lymphoma (DLBCL): a monotherapy study that has the potential to be pivotal, a combination study with chemotherapy, and a combination study with lenalidomide.
- MTEM expects to report updates on all three MT-3724 studies in 2H20.
TAK-169 (CD38 ETB)
Takedaand MTEM are conducting an ongoing Phase I study for TAK-169 in relapsed/refractory multiple myeloma.
MT-5111 (HER2 ETB)
- MTEM is conducting an ongoing Phase I study of MT-5111 in HER2-positive cancers.
- MTEM expects to provide a data update from the MT-5111 Phase I study in 2Q20 and release additional data from the dose escalation portion of the study in 4Q20.
- 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.
- MTEM expects to present preclinical data on several new targets ETB programs at upcoming medical conferences including the
American Association for Cancer Research (AACR) VirtualAnnual Meeting II, taking place June 22-24, 2020.
The net loss attributable to common shareholders for the first quarter of 2020 was
Revenues for the first quarter of 2020 were
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 MT-3724, MT-5111, TAK-169, and MT-6402; the expected timing of submitting various IND applications and conducting studies; the expected participation and presentation at upcoming medical conferences; 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; risks from global pandemics including COVID-19; 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
Chief Financial Officer
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
|Three Months Ended
|Research and development revenue - from related party||$||333||$||6,413|
|Research and development revenue - other||1,467||—|
|Research and development||20,631||8,454|
|General and administrative||5,647||4,935|
|Total operating expenses||26,278||13,389|
|Loss from operations||22,137||6,381|
|Interest and other income, net||472||510|
|Interest and other expense, net||(348||)||(293||)|
|Change in fair value of warrant liabilities||—||(4||)|
|Loss before provision for income taxes||22,013||6,168|
|Provision for income taxes||5||—|
|Net loss attributable to common shareholders||$||22,018||$||6,168|
|Net loss per share attributable to common shareholders:|
|Basic and diluted||$||0.48||$||0.17|
|Weighted average number of shares used in net loss per share calculations:|
|Basic and diluted||45,649,065||36,738,993|
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
|Cash and cash equivalents||$||34,444||$||85,451|
|Marketable securities, current||70,544||39,633|
|Grants revenue receivable||9,441||7,100|
|Accounts receivable, related party||1,300||408|
|In-process research and development - held for sale||4,500||4,500|
|Other current assets||242||489|
|Total current assets||124,198||139,899|
|Marketable securities, non-current||3,010||1,510|
|Operating lease right-of-use assets, non-current||9,617||9,959|
|Property and equipment, net||19,301||18,158|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Deferred revenue, current||11,465||8,511|
|Deferred revenue, current, related party||8,773||8,780|
|Other current liabilities, related party||7,754||—|
|Other current liabilities||2,543||2,501|
|Total current liabilities||43,836||35,801|
|Deferred revenue, long-term||14,523||18,944|
|Deferred revenue, long-term, related party||1,355||441|
|Long-term debt, net||2,888||2,940|
|Operating lease liabilities, non-current||11,232||11,682|
|Commitments and contingencies|
|Authorized: 2,000,000 shares at
|Authorized: 150,000,000 shares; issued and outstanding: 45,703,934 shares at
|Additional paid-in capital||269,581||267,089|
|Accumulated other comprehensive income||282||18|
|Total stockholders’ equity||83,766||103,028|
|Total liabilities and stockholders’ equity||$||160,743||$||174,202|
Source: Molecular Templates, Inc.