Molecular Templates, Inc. Reports Fourth Quarter 2020 Financial Results
March 18 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 fourth quarter of 2020.
“In 2020 and early 2021, we made important
progress by advancing our pipeline programs, establishing a new
collaboration with a premier oncology 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 four clinical stage programs: MT-5111
targeting HER2, TAK-169 targeting CD38 in co-development with
Takeda, MT-6402 with antigen seeding targeting PD-L1, and MT-3724,
for which we are working to resolve the FDA partial clinical hold.
We expect to generate clinical data from multiple programs and
advance our earlier stage programs in 2021, including filing an IND
for an ETB targeting CTLA-4, preclinical data presentations on ETBs
against new targets, and continued progress in our collaborations
with Bristol Myers Squibb, Vertex, and Takeda.”
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.
- MTEM has had three abstracts accepted for presentation at the
upcoming American Association for Cancer Research (AACR) Annual
Meeting 2021, taking 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. 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 1H21 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 present interim
clinical results from the dose escalation portion of the MT-5111
Phase 1 study as of December 2020, at the AACR Annual Meeting April
10-15, 2021. 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)
- Takeda and MTEM are currently
conducting a 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.
- In December 2020, preclinical
TAK-169 data were presented at the 62nd ASH Annual Meeting and
Exposition.
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.
MT-3724 (CD20 ETB)
- Since November 4, 2020, all MT-3724
clinical studies have been on partial clinical hold as ordered by
the FDA following a treatment-related fatality in one subject who
experienced Grade 5 CLS in the Phase 2 MT-3724 monotherapy study.
As part of the overall investigation into the partial clinical hold
on MT-3724, MTEM investigated MT-3724 product quality attributes.
Based on the findings, MTEM submitted a partial clinical hold
response to the FDA in February 2021 in which it proposed to
implement new drug product manufacturing and release
specifications.
- MTEM is working to address the
partial clinical hold and MT-3724 product lot information requests
from the FDA.
- In tandem, MTEM is actively
evaluating the role of MT-3724 and CD20 as a target in MTEM’s
portfolio relative to other opportunities.
Research
- MTEM expects to file an IND
application for an ETB targeting CTLA-4 in 4Q21.
- Several other ETB candidates are in
preclinical development against targets including SLAMF-7 and
CD45.
- 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 fourth quarter of 2020 was $28.4 million, or $0.57 per
basic and diluted share. This compares with a net loss attributable
to common shareholders of $15.9 million, or $0.41 per basic and
diluted share, for the same period in 2019.
Revenues for the fourth quarter of 2020 were
$3.5 million, compared to $6.2 million for the same period in 2019.
Revenues for the fourth quarter of 2020 were comprised of revenues
from collaborative research and development agreements with Takeda
and Vertex. Total research and development expenses for the fourth
quarter of 2020 were $22.3 million, compared with $16.6 million for
the same period in 2019. Total general and administrative expenses
for the fourth quarter of 2020 were $7.1 million, compared with
$6.0 million for the same period in 2019.
As of December 31, 2020, MTEM’s cash and
investments totaled $93.9 million. With the addition of the $70
million upfront payment from Bristol Myers Squibb received in 1Q21
and the proceeds of the public equity offering completed in
February 2021, 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 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 relating to the potential lifting of the
partial clinical hold on Molecular Templates’ MT-3724 clinical
trials; our investigation into MT-3724 product attributes and
potential plans for our MT-3724 studies; statements regarding the
safety or potential efficacy of Molecular Templates’ drug or
biologic candidates; statements relating to the development of
MT-3724, MT-5111, TAK-169, and MT-6402; the expected timing of
submitting various IND applications and conducting studies and
generating data; 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, Molecular Templates’ ability to
satisfactorily respond to requests from the FDA for further
information and data regarding MT-3724 on the timeline expected or
at all; successfully resolve the partial clinical hold with regard
to MT-3724; 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. 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.com862-204-4006
Molecular Templates, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(in thousands, except share and per
share data) (unaudited)
|
Three Months EndedDecember 31, |
|
|
Year EndedDecember 31, |
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Research and development revenue - from related party |
$ |
1,605 |
|
|
$ |
4,688 |
|
|
$ |
6,567 |
|
|
$ |
19,499 |
|
Research and development
revenue - other |
|
1,892 |
|
|
— |
|
|
|
9,068 |
|
|
— |
|
Grant revenue |
|
— |
|
|
|
1,509 |
|
|
|
3,210 |
|
|
|
2,771 |
|
Total revenue |
|
3,497 |
|
|
|
6,197 |
|
|
|
18,845 |
|
|
|
22,270 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
Research and development |
|
22,298 |
|
|
|
16,573 |
|
|
|
92,965 |
|
|
|
50,519 |
|
General and administrative |
|
7,116 |
|
|
|
6,028 |
|
|
|
26,722 |
|
|
|
20,077 |
|
Loss on impairment of in-process research and development |
— |
|
|
— |
|
|
|
— |
|
|
|
22,123 |
|
Total operating expenses |
|
29,414 |
|
|
|
22,601 |
|
|
|
119,687 |
|
|
|
92,719 |
|
Loss from operations |
|
25,917 |
|
|
|
16,404 |
|
|
|
100,842 |
|
|
|
70,449 |
|
Interest and other income,
net |
|
103 |
|
|
|
873 |
|
|
|
1,028 |
|
|
|
2,323 |
|
Interest and other expense,
net |
|
(476 |
) |
|
|
(351 |
) |
|
|
(1,705 |
) |
|
|
(1,298 |
) |
Loss on Extinguishment of
Debt |
|
— |
|
|
— |
|
|
|
(1,237 |
) |
|
— |
|
Loss on disposal of
assets |
|
(2,155 |
) |
|
— |
|
|
|
(2,155 |
) |
|
— |
|
Change in fair value of
warrant liabilities |
|
— |
|
|
— |
|
|
|
— |
|
|
|
3 |
|
Loss before provision
(benefit) for income taxes |
|
28,445 |
|
|
|
15,882 |
|
|
|
104,911 |
|
|
|
69,421 |
|
Provision for income
taxes |
— |
|
|
— |
|
|
|
5 |
|
|
— |
|
Net loss attributable to
common shareholders |
|
28,445 |
|
|
|
15,882 |
|
|
|
104,916 |
|
|
|
69,421 |
|
Net loss per share
attributable to common shareholders: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
0.57 |
|
|
$ |
0.41 |
|
|
$ |
2.20 |
|
|
$ |
1.86 |
|
Weighted average number of
shares used in net loss per share calculations: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
49,970,514 |
|
|
|
40,552,083 |
|
|
|
47,603,261 |
|
|
|
37,770,378 |
|
Molecular Templates, Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS(in
thousands, except share and per share data)
|
|
December 31,2020 |
|
|
December 31,2019 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
25,218 |
|
|
$ |
85,451 |
|
Marketable securities, current |
|
|
68,667 |
|
|
|
39,633 |
|
Prepaid expenses |
|
|
6,080 |
|
|
|
2,318 |
|
Grants revenue receivable |
|
|
— |
|
|
|
7,100 |
|
Accounts receivable, related party |
|
|
234 |
|
|
|
408 |
|
In-process research and development - held for sale |
|
|
— |
|
|
|
4,500 |
|
Other current assets |
|
|
1,125 |
|
|
|
489 |
|
Total current assets |
|
|
101,324 |
|
|
|
139,899 |
|
Marketable securities, non-current |
|
|
— |
|
|
|
1,510 |
|
Operating lease right-of-use assets |
|
|
11,104 |
|
|
|
9,959 |
|
Property and equipment, net |
|
|
22,254 |
|
|
|
18,158 |
|
Other assets |
|
|
5,195 |
|
|
|
4,676 |
|
Total assets |
|
$ |
139,877 |
|
|
$ |
174,202 |
|
LIABILITIES AND STOCKHOLDERS’
EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,350 |
|
|
$ |
1,465 |
|
Accrued liabilities |
|
|
12,575 |
|
|
|
14,544 |
|
Deferred revenue, current |
|
|
14,014 |
|
|
|
8,511 |
|
Deferred revenue, current, related party |
|
|
789 |
|
|
|
8,780 |
|
Other current liabilities, related party |
|
|
5,614 |
|
|
|
— |
|
Other current liabilities |
|
|
2,211 |
|
|
|
2,501 |
|
Total current liabilities |
|
|
37,553 |
|
|
|
35,801 |
|
Deferred revenue, long-term |
|
|
4,538 |
|
|
|
18,944 |
|
Deferred revenue, long-term, related party |
|
|
3,106 |
|
|
|
441 |
|
Long-term debt, net |
|
|
14,926 |
|
|
|
2,940 |
|
Operating lease liabilities |
|
|
12,213 |
|
|
|
11,682 |
|
Other liabilities, related party |
|
|
6,711 |
|
|
|
— |
|
Other liabilities |
|
|
1,490 |
|
|
|
1,366 |
|
Total liabilities |
|
|
80,537 |
|
|
|
71,174 |
|
Commitments and contingencies
(Note 10) |
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value: |
|
|
|
|
|
|
|
|
Authorized: 2,000,000 shares at December 31, 2020 and |
|
|
|
|
|
|
|
|
December 31, 2019; issued and outstanding: 250 shares at
December 31, 2020 and December 31, 2019 |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value: |
|
|
|
|
|
|
|
|
Authorized: 150,000,000 shares at December 31, 2020 and |
|
|
|
|
|
|
|
|
December 31, 2019; issued and outstanding: 49,984,333 shares
at December 31, 2020 and 45,589,157 shares at December 31,
2019 |
|
|
50 |
|
|
|
46 |
|
Additional paid-in capital |
|
|
328,314 |
|
|
|
267,089 |
|
Accumulated other comprehensive income |
|
|
17 |
|
|
|
18 |
|
Accumulated deficit |
|
|
(269,041 |
) |
|
|
(164,125 |
) |
Total stockholders’ equity |
|
|
59,340 |
|
|
|
103,028 |
|
Total liabilities and stockholders’ equity |
|
$ |
139,877 |
|
|
$ |
174,202 |
|
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