Molecular Templates, Inc. Reports First Quarter 2021 Financial Results
May 13 2021 - 4:30PM
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), today
reported financial results for the first quarter of 2021.
“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) 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 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.
About Molecular Templates
Molecular Templates is a clinical-stage
biopharmaceutical company focused on the discovery and development
of targeted biologic therapeutics. Our proprietary drug platform
technology, known as engineered toxin bodies, or ETBs, leverages
the resident biology of a genetically engineered form of Shiga-like
Toxin A subunit to create novel therapies with potent and
differentiated mechanisms of action for cancer and other serious
diseases.
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 regarding the safety or potential efficacy
of Molecular Templates’ drug or biologic candidates, including the
anticipated benefits of Molecular Templates’ next-generation ETBs
compared to its first-generation ETBs, such as MT-3724; statements
relating to the development of MT-5111, TAK-169, and MT-6402; the
expected timing of submitting various IND applications and
conducting studies and generating data; Molecular Templates’
receipt of future development, regulatory and sales milestones and
royalty payments; the expected participation and presentation at
upcoming conferences; the anticipated effects of the COVID-19
pandemic on Molecular Templates’ ongoing clinical studies,
manufacturing and preclinical development; and Molecular Templates’
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 Molecular
Templates’ cash resources will be sufficient to fund its continuing
operations for the periods and/or trials anticipated; the ability
of Molecular Templates’ 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
Molecular Templates’ filings with the SEC. There can be no
assurance that any of Molecular Templates’ drug or biologic
candidates will be successfully developed, manufactured or
commercialized, that final results of clinical trials will be
supportive of regulatory approvals required to market products, or
that any of the forward-looking information provided herein will be
proven accurate. Any forward-looking statements contained in this
press release speak only as of the date hereof, and Molecular
Templates 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.com 862-204-4006
Molecular Templates, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(in thousands, except share and per
share data) (unaudited)
|
Three Months EndedMarch 31, |
|
|
2021 |
|
|
2020 |
|
Research and development revenue, related party |
$ |
237 |
|
|
$ |
333 |
|
Research and development
revenue, other |
|
2,983 |
|
|
|
1,467 |
|
Grant revenue |
|
— |
|
|
|
2,341 |
|
Total revenue |
|
3,220 |
|
|
|
4,141 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
21,368 |
|
|
|
20,631 |
|
General and administrative |
|
8,181 |
|
|
|
5,647 |
|
Total operating expenses |
|
29,549 |
|
|
|
26,278 |
|
Loss from operations |
|
26,329 |
|
|
|
22,137 |
|
Interest and other income,
net |
|
52 |
|
|
|
472 |
|
Interest and other expense,
net |
|
(501 |
) |
|
|
(348 |
) |
Loss before provision for
income taxes |
|
26,778 |
|
|
|
22,013 |
|
Provision for income
taxes |
|
— |
|
|
|
5 |
|
Net loss |
|
26,778 |
|
|
|
22,018 |
|
Net loss attributable to
common shareholders |
$ |
26,778 |
|
|
$ |
22,018 |
|
Net loss per share
attributable to common shareholders: |
|
|
|
|
|
|
|
Basic and diluted |
$ |
0.51 |
|
|
$ |
0.48 |
|
Weighted average number of
shares used in net loss per share calculations: |
|
|
|
|
|
|
|
Basic and diluted |
|
52,564,628 |
|
|
|
45,649,065 |
|
Molecular Templates, Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS(in
thousands, except share and per share data)
|
|
March 31,2021(unaudited) |
|
|
December 31,2020 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
98,786 |
|
|
$ |
25,218 |
|
Marketable securities, current |
|
|
103,498 |
|
|
|
68,667 |
|
Prepaid expenses |
|
|
6,178 |
|
|
|
6,080 |
|
Accounts receivable, related party |
|
|
— |
|
|
|
234 |
|
Other current assets |
|
|
719 |
|
|
|
1,125 |
|
Total current assets |
|
|
209,181 |
|
|
|
101,324 |
|
Marketable securities, non-current |
|
|
5,115 |
|
|
|
— |
|
Operating lease right-of-use assets |
|
|
10,625 |
|
|
|
11,104 |
|
Property and equipment, net |
|
|
21,707 |
|
|
|
22,254 |
|
Other assets |
|
|
5,146 |
|
|
|
5,195 |
|
Total assets |
|
$ |
251,774 |
|
|
$ |
139,877 |
|
LIABILITIES AND STOCKHOLDERS’
EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,804 |
|
|
$ |
2,350 |
|
Accrued liabilities |
|
|
9,801 |
|
|
|
12,575 |
|
Deferred revenue, current |
|
|
49,453 |
|
|
|
14,014 |
|
Deferred revenue, current, related party |
|
|
1,072 |
|
|
|
789 |
|
Other current liabilities, related party |
|
|
12,060 |
|
|
|
5,614 |
|
Other current liabilities |
|
|
2,386 |
|
|
|
2,211 |
|
Total current liabilities |
|
|
76,576 |
|
|
|
37,553 |
|
Deferred revenue, long-term |
|
|
36,117 |
|
|
|
4,538 |
|
Deferred revenue, long-term, related party |
|
|
2,586 |
|
|
|
3,106 |
|
Long-term debt, net of current portion |
|
|
15,031 |
|
|
|
14,926 |
|
Operating lease liabilities |
|
|
11,586 |
|
|
|
12,213 |
|
Other liabilities, related party |
|
|
— |
|
|
|
6,711 |
|
Other liabilities |
|
|
1,523 |
|
|
|
1,490 |
|
Total liabilities |
|
|
143,419 |
|
|
|
80,537 |
|
Commitments and contingencies
(Note 10) |
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value: |
|
|
|
|
|
|
|
|
Authorized: 2,000,000 shares at March 31, 2021 and
December 31, 2020; issued and outstanding: 250 shares at March
31, 2021 and December 31, 2020 |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value: |
|
|
|
|
|
|
|
|
Authorized: 150,000,000 shares at March 31, 2021 and
December 31, 2020; issued and outstanding: 56,082,931 shares
at March 31, 2021 and 49,984,333 shares at December 31,
2020 |
|
|
56 |
|
|
|
50 |
|
Additional paid-in capital |
|
|
404,116 |
|
|
|
328,314 |
|
Accumulated other comprehensive income |
|
|
2 |
|
|
|
17 |
|
Accumulated deficit |
|
|
(295,819 |
) |
|
|
(269,041 |
) |
Total stockholders’ equity |
|
|
108,355 |
|
|
|
59,340 |
|
Total liabilities and stockholders’ equity |
|
$ |
251,774 |
|
|
$ |
139,877 |
|
|
|
|
|
|
|
|
|
|
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