Molecular Templates, Inc. Reports First Quarter 2019 Financial Results
May 13 2019 - 4:01PM
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
Corporate
- 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.
TAK-169
- Takeda and Molecular expect to file an IND and start a Phase I
multiple myeloma trial in 2019 for TAK-169 (CD38 targeted
ETB).
MT-3724
- 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.
MT-5111
- 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.
Research
- 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.
Financial Results
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.
Forward-Looking Statements
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.
Contact:
Adam CutlerChief Financial
Officeradam.cutler@mtem.com862-204-4006
|
|
Molecular Templates, Inc. |
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
(in thousands, except share and per share
data) |
|
(unaudited) |
|
|
|
|
Three Months
EndedMarch 31, |
|
|
2019 |
|
|
2018 |
|
Research and development revenue – from related party |
$ |
6,413 |
|
|
$ |
163 |
|
Research and development revenue – other |
|
— |
|
|
|
68 |
|
Grant revenue |
|
595 |
|
|
|
251 |
|
Total revenue |
|
7,008 |
|
|
|
482 |
|
Operating expenses: |
|
|
|
|
|
|
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 31,2019 |
|
|
December 31,2018 |
|
|
(unaudited) |
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
37,855 |
|
|
$ |
87,721 |
|
Marketable Securities, Current |
|
45,720 |
|
|
|
10,234 |
|
Prepaid expenses |
|
2,005 |
|
|
|
2,244 |
|
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 |
|
Other assets |
|
4,783 |
|
|
|
1,821 |
|
Total assets |
$ |
140,605 |
|
|
$ |
140,158 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
1,582 |
|
|
$ |
780 |
|
Accrued liabilities |
|
5,979 |
|
|
|
5,357 |
|
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 |
|
|
|
— |
|
Other liabilities |
|
374 |
|
|
|
819 |
|
Total liabilities |
|
44,468 |
|
|
|
39,252 |
|
Total stockholders’ equity |
|
96,137 |
|
|
|
100,906 |
|
Total liabilities and stockholders’ equity |
$ |
140,605 |
|
|
$ |
140,158 |
|
|
|
|
|
|
|
|
|
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