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”), to create
novel therapies with potent differentiated mechanisms of action for
cancer, today reported financial results for the fourth quarter and
full year ended December 31, 2023.
Company Highlights
-
Durable single agent activity observed with MT-6402, a PD-L1
targeting direct-cell kill agent, in heavily pre-treated patients
with low PD-L1+ head and neck cancer who had progressed on multiple
prior therapies including checkpoint and EGFR antibodies.
-
Enrollment is on-going in the dose escalation study with MT-8421, a
novel CTLA-4 targeting agent designed to potently deplete Tregs in
the tumor environment. Unique pharmacodynamic effects demonstrating
potent Treg clearance and IL-2 increases observed in patients.
-
Recently completed $9.5 million private placement supports
continued funding of clinical stage programs.
Eric Poma, PhD., Chief Executive and Chief
Scientific Officer of MTEM, stated, “We are very excited to see
objective responses in heavily pre-treated, checkpoint-experienced
head and neck cancer patients, a setting with high unmet medical
need, with MT-6402. We are seeing evidence of monotherapy activity
of long duration and in patients refractory to checkpoint therapy
through a novel mechanism of tumor microenvironment remodeling. We
believe these data demonstrate a new and potentially best-in-class
approach to targeting the PD-1-PD-L1 axis.” Dr. Poma further added,
“MT-8421 is currently in dose escalation as a novel direct
cell-kill approach targeting CTLA-4 to potently deplete Tregs in
the tumor microenvironment. Through the first dose cohort, we are
already seeing promising and differentiate pharmacodynamic effects
including dramatic Treg depletion in patients.”
MT-6402 (PD-L1 ETB)
- MT-6402 was
designed to activate T-cells through direct cell-kill of
immunosuppressive PD-L1+ immune cells resulting in a remodeling of
the tumor microenvironment.
- In addition,
MT-6402 can deliver and induce the presentation of an MHC class I
CMV antigen on tumor cells for pre-existing CD8 T-cell recognition
and destruction in HLA-A*02/CMV+ patients with high PD-L1
expression on their tumors.
- Compelling
signal of monotherapy activity with MT-6402 at higher doses in
relapsed or refractory head and neck cancer (R-R HNSCC) with dose
expansion study planned in low PD-L1+ R-R HNSCC patients.
- 10 patients with
R-R HNSCC in dose escalation
- Patients dosed
at 63, 83 (MTD), or 100 mcg/kg; median # of prior treatments of
greater than 3
- 2 patients
currently in responses; 1 patient (63 mcg/kg) has a confirmed PR
with 70% reduction in tumor volume at cycle 18 (1 cycle = 4
weeks)
- 1 patient (83
mcg/kg) has an uPR(37% reduction) at cycle 8 w/ reductions of 3%,
9%, and 15% across three previous cycles; the patient is on therapy
in cycle 9
- 2 patients (one
uPR and one 15% reduction) came off therapy for Gr1 hs-Trop
elevation; guidelines now revised to allow patients to continue
therapy despite advent of Gr1 hs-Trop elevation. In all instances,
Gr1 hs-Trop elevations were asymptomatic and without evidence of
cardiac changes. Similar troponin changes are observed in patients
receiving checkpoint inhibitors.
- No gr 4 or gr 5
drug-related toxicities were observed
- Patients with
responses/tumor reduction had low PD-L1
- Dose expansion
is on-going in patients with high PD-L1+ tumors.
MT-8421 (CTLA-4 ETB)
- MT-8421, along with
MT-6402, represents our unique approach to immuno-oncology based on
remodeling the tumor microenvironment through the elimination of
immunosuppressive cells and activation of CD8 T-cells.
- MT-8421 is designed
to potently destroy CTLA-4+ Tregs via enzymatic ribosome
destruction but does not have activity against low CTLA-4
expressing peripheral Tregs.
- Two of the three
patients enrolled in the first cohort remain on study in cycle 5.
Both patients show evidence of Treg clearance and T-cell
activation. Enrollment is on-going in the second cohort of 48
mcg/kg for the phase I study of MT-8421.
MT-0169 (CD38 ETB)
- MT-0169 is designed
to destroy CD38+ tumor cells through internalization of CD38 and
cell destruction via a novel mechanism of action (enzymatic
ribosomal destruction and immunogenic cell death).
- A phase 1 study in
patients with relapsed or refractory multiple myeloma was closed on
Dec 2023 due to slow patient enrollment in the wake of multiple new
approvals in myeloma. This study enrolled 14 patients and no
drug-related Grade 4 or 5 adverse events have been observed. One
patient with IgA myeloma who was quad-refractory was treated at 5
mcg/kg and had a stringent Complete Response for 16 cycles (1 cycle
= 4 weeks) before discontinuing treatment for progression of
disease.
- MTEM is evaluating
plans to initiate an investigator sponsored study to evaluate
MT-0169 in relapsed or refractory CD38+ AML patients.
Second Closing of July 2023 Private
Placement
On March 28, 2024, the Company and certain
institutional and accredited investors (the “March 2024
Purchasers”) entered into an Amended and Restated July 2023
Purchase Agreement pursuant to which the Company will issue common
stock, prefunded warrants, and common warrants with an aggregate
purchase price of $9.5 million on amended and restated second
tranche terms. The second tranche, as amended and restated, will
consist of the sale and issuance of (i) 1,209,612 shares of the
Company’s common stock (and, in lieu thereof, prefunded warrants to
purchase 2,460,559 shares of the Company’s common stock (the “March
2024 Prefunded Warrants”)) for a purchase price of $2.35 per share
of the Company’s common stock (the closing price of our common
stock on March 27, 2024 as reported by the Nasdaq Capital Market)
and $2.349 per March 2024 Prefunded Warrant, and (ii) common stock
warrants (the “March 2024 Common Warrants”) to purchase up to
7,340,342 shares of the Company’s common stock (or March 2024
Prefunded Warrants in lieu thereof) at an exercise price of $2.35
per share of the Company’s common stock underlying the March 2024
Common Warrants. The March 2024 Common Warrants will be sold at a
price of $0.125 per underlying share of common stock and will have
a term of five years. The March 2024 Prefunded Warrants will expire
when fully exercised in accordance with their terms. The March 2024
Prefunded Warrants and March 2024 Common Warrants may not be
exercised if the aggregate number of shares of our common stock
beneficially owned by the holder thereof immediately following such
exercise would exceed a specified beneficial ownership limitation
(4.99%/9.99%/19.99%); provided, however, that a holder may increase
or decrease the beneficial ownership limitation by giving 61 days’
notice to the Company, but not to any percentage in excess of
19.99%. The Amended and Restated July 2023 Purchase Agreement
contains customary representations and warranties and agreements of
the Company and the Purchasers and customary indemnification rights
and obligations of the parties. The second tranche will include
gross proceeds of approximately $9.5 million and net proceeds,
following the payment of related offering expenses, of
approximately $8.9 million.
Key Milestones for 2024
- Clinical data on
MT-6402 expansion cohorts in low and high PD-L1+ HNSCC
patients
- Clinical data from
dose escalation study for MT-8421 Treg depleting agent in solid
tumors
Bristol-Myers Squibb Collaboration
Agreement
On March 13, 2024, Bristol-Myers Squibb notified the Company
that following a corporate portfolio prioritization process, it
does not intend to continue the research collaboration it entered
into with the Company pursuant to the BMS Collaboration Agreement
and would be terminating the BMS Collaboration Agreement in its
entirety. The termination will be effective on June 13, 2024, or 90
days following the Company’s receipt of Bristol-Myers Squibb’s
written notice of termination. MTEM plans to reduce costs related
to the Collaboration Agreement.
Conferences
MTEM will present an abstract, “First-in-human, dose escalation
and expansion study of MT-6402, a novel engineered toxin body (ETB)
targeting PD-L1, in patients with PD-L1 expressing
relapsed/refractory advanced solid tumors: Interim Data”, Tuesday,
April 9, 2024, 9am – 12:30pm ET (Section 48, Poster #19, Abstract
#CT191), at the American Association for Cancer Research (“AACR”)
Annual Meeting taking place in San Diego, CA.
Financial Results
The net loss attributable to common shareholders for the fourth
quarter of 2023 was $3.9 million, or $0.73 per basic and diluted
share. This compares with a net loss attributable to common
shareholders of $22.0 million, or $5.87 per basic and diluted
share, for the same period in 2022.
Revenues for the fourth quarter of 2023 were $7.0 million,
compared to $2.6 million for the same period in 2022. Revenues for
the fourth quarter of 2023 were comprised of revenues from
collaborative research and development agreements with
Bristol-Myers Squibb and grant revenue.
Total research and development expenses for the fourth quarter
of 2023 were $8.8 million, compared with $17.6 million for the same
period in 2022. Total general and administrative expenses for the
fourth quarter of 2023 were $3.6 million, compared with $6.1
million for the same period in 2022.
As of December 31, 2023, MTEM’s unrestricted cash and cash
equivalents totaled $11.5 million. MTEM anticipates a cash runway
into the second quarter of 2024. Following the completion of the
recent Second Closing of the July 2023 Private Placement, the
Company anticipates that cash runway will extend to the end of the
fourth quarter 2024.
For more details on MTEM’s financial results for 2023, refer to
Form 10-K filed with the SEC.
|
Molecular Templates, Inc. CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (in
thousands, except share and per share data)
(unaudited) |
|
|
Three Months Ended
December 31, |
|
Year Ended December 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Research and development
revenue |
$ |
6,639 |
|
|
$ |
2,611 |
|
|
$ |
52,625 |
|
|
$ |
19,754 |
|
Grant revenue |
|
377 |
|
|
|
— |
|
|
|
4,681 |
|
|
|
— |
|
Total revenue |
|
7,016 |
|
|
|
2,611 |
|
|
|
57,306 |
|
|
|
19,754 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
8,796 |
|
|
|
17,590 |
|
|
|
48,875 |
|
|
|
82,425 |
|
General and administrative |
|
3,591 |
|
|
|
6,080 |
|
|
|
18,897 |
|
|
|
26,200 |
|
Total operating expenses |
|
12,387 |
|
|
|
23,670 |
|
|
|
67,772 |
|
|
|
108,625 |
|
Loss from operations |
|
5,371 |
|
|
|
21,059 |
|
|
|
10,466 |
|
|
|
88,871 |
|
Interest and other income,
net |
|
178 |
|
|
|
425 |
|
|
|
1,208 |
|
|
|
988 |
|
Interest and other expense,
net |
|
(39 |
) |
|
|
(1,351 |
) |
|
|
(2,654 |
) |
|
|
(4,716 |
) |
Gain on extinguishment of
debt |
|
— |
|
|
|
— |
|
|
|
1,795 |
|
|
|
— |
|
Change in valuation of contingent
value right |
|
1,273 |
|
|
|
— |
|
|
|
2,457 |
|
|
|
— |
|
Loss on disposal of property and
equipment |
|
— |
|
|
|
(37 |
) |
|
|
(475 |
) |
|
|
(66 |
) |
Loss before provision (benefit)
for income taxes |
|
3,959 |
|
|
|
22,022 |
|
|
|
8,135 |
|
|
|
92,665 |
|
Provision (benefit) for income
taxes |
|
(11 |
) |
|
|
27 |
|
|
|
(11 |
) |
|
|
53 |
|
Net loss attributable to
common shareholders |
$ |
3,948 |
|
|
$ |
22,049 |
|
|
$ |
8,124 |
|
|
$ |
92,718 |
|
Net loss per share
attributable to common shareholders: |
|
|
|
|
|
|
|
Basic and diluted |
$ |
0.73 |
|
|
$ |
5.87 |
|
|
$ |
1.80 |
|
|
$ |
24.69 |
|
Weighted average number of
shares used in net loss per share calculations: |
|
|
|
|
|
|
|
Basic and diluted |
|
5,374,268 |
|
|
|
3,756,711 |
|
|
|
4,501,206 |
|
|
|
3,755,564 |
|
|
Molecular Templates, Inc. CONDENSED
CONSOLIDATED BALANCE SHEETS (in thousands, except
share and per share data) |
|
|
December 31,2023 |
|
December 31,2022 |
ASSETS |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
11,523 |
|
|
$ |
32,190 |
|
Marketable securities, current |
|
— |
|
|
|
28,859 |
|
Prepaid expenses |
|
2,195 |
|
|
|
3,459 |
|
Grants revenue receivable |
|
250 |
|
|
|
— |
|
Other current assets |
|
2,804 |
|
|
|
3,790 |
|
Total current assets |
|
16,772 |
|
|
|
68,298 |
|
Operating lease right-of-use assets |
|
9,161 |
|
|
|
11,132 |
|
Property and equipment, net |
|
7,393 |
|
|
|
14,632 |
|
Other assets |
|
2,057 |
|
|
|
3,486 |
|
Total assets |
$ |
35,383 |
|
|
$ |
97,548 |
|
LIABILITIES AND STOCKHOLDERS’
EQUITY/(DEFICIT) |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
1,523 |
|
|
$ |
504 |
|
Accrued liabilities |
|
4,279 |
|
|
|
8,823 |
|
Deferred revenue, current |
|
9,031 |
|
|
|
45,573 |
|
Other current liabilities |
|
2,488 |
|
|
|
2,182 |
|
Total current liabilities |
|
17,321 |
|
|
|
57,082 |
|
Deferred revenue, long-term |
|
— |
|
|
|
5,904 |
|
Long-term debt, net of current portion |
|
— |
|
|
|
36,168 |
|
Operating lease liabilities, long term portion |
|
9,742 |
|
|
|
12,231 |
|
Contingent value right liability |
|
2,702 |
|
|
|
— |
|
Other liabilities |
|
1,406 |
|
|
|
1,295 |
|
Total liabilities |
|
31,171 |
|
|
|
112,680 |
|
Commitments and
contingencies |
|
|
|
|
|
Stockholders’ equity/(deficit) |
|
|
|
|
|
Preferred stock, $0.001 par value per share: |
|
|
|
|
|
Authorized: 2,000,000 shares as of December 31, 2023 and 2022;
Issued and outstanding: 250 shares as of December 31, 2023 and
2022 |
|
— |
|
|
|
— |
|
Common stock, $0.001 par value per share: |
|
|
|
|
|
Authorized: 150,000,000 shares as of December 31, 2023 and
2022; Issued and outstanding: 5,374,268 shares as of
December 31, 2023 and 3,756,711 shares as of December 31,
20221 |
|
5 |
|
|
|
4 |
|
Additional paid-in capital1 |
|
457,099 |
|
|
|
429,698 |
|
Accumulated other comprehensive loss |
|
— |
|
|
|
(66 |
) |
Accumulated deficit |
|
(452,892 |
) |
|
|
(444,768 |
) |
Total stockholders’ equity/(deficit) |
|
4,212 |
|
|
|
(15,132 |
) |
Total liabilities and stockholders’
equity/(deficit) |
$ |
35,383 |
|
|
$ |
97,548 |
|
|
1. Prior period amounts have been retrospectively adjusted for
the 1-for-15 reverse stock split that was effective August 11,
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.
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, including, but not limited to those
regarding strategy, future operations, the Company’s ability to
execute on its objectives, prospects, plans, future clinical
development of the Company’s product candidates, any implication
that the preliminary results, interim results, or the results of
earlier clinical trials or ongoing clinical trials will be
representative of the results of future or later clinical trials or
final results, the potential benefits, safety or efficacy and any
evaluations or judgements regarding the Company’s product
candidates, [the results of any strategic process which are
inherently uncertain at the present time] and future execution of
corporate goals. In addition, when or if used in this press
release, the words “may,” “could,” “should,” “continue”,
“anticipate,” “potential”, “believe,” “estimate,” “appears”,
“expect,” “intend,” “plan,” “predict” and similar expressions and
their variants, as they relate to Molecular Templates may identify
forward-looking statements. 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 following: the
continued availability of financing on commercially reasonable
terms, whether Molecular Templates’ cash resources will be
sufficient to fund its continuing operations; the results of MTEM’s
ongoing clinical studies and the ability to effectively operate
MTEM, and those risks identified under the heading “Risk Factors”
in Molecular Templates’ filings with the Securities and Exchange
Commission (the “SEC”), including its Form 10-K for the year ended
December 31, 2023 and any subsequent reports filed 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.
Contacts:grace.kim@mtem.com
Molecular Templates (NASDAQ:MTEM)
過去 株価チャート
から 11 2024 まで 12 2024
Molecular Templates (NASDAQ:MTEM)
過去 株価チャート
から 12 2023 まで 12 2024