TCR² Therapeutics Reports Third Quarter 2022 Financial Results and Provides Corporate Update
November 08 2022 - 6:45AM
TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell
therapy company with a pipeline of novel T cell therapies for
cancer patients suffering from solid tumors, today announced
financial results for the third quarter ended September 30, 2022
and provided a corporate update.
"TCR2 continued to execute on its streamlined
corporate priorities in the last quarter and stands poised to
deliver multiple clinical catalysts over the next 12 months on our
two core assets, gavo-cel and TC-510," said Garry Menzel, Ph.D.,
President and Chief Executive Officer of TCR2 Therapeutics. "In the
Phase 1 trial for gavo-cel, we observed promising activity in
ovarian cancer, leading us to place greater and earlier emphasis on
this indication. We also established a baseline clinical profile
which we believe positions gavo-cel as a first- and best-in-class
anti-mesothelin monotherapy which we aim to further enhance with
the addition of checkpoint inhibitors and redosing strategies in
the Phase 2 portion of the trial. In addition, we have begun
treating patients with our second product candidate, TC-510, a
TRuC-T cell enhanced with a PD-1:CD28 chimeric switch receptor.
These near-term focused activities will allow us to further
maximize the number of cancer patients with access to our
investigational therapies."
Recent Developments
gavo-cel:
- TCR2 announced positive topline
results from the complete Phase 1 dose escalation portion of the
gavo-cel Phase 1/2 clinical trial for mesothelin-expressing solid
tumors. Twenty-eight of the 30 patients evaluable for efficacy
experienced regression of their target lesions, including eight
patients who achieved a partial response (PR) by target lesion
assessment, six of whom met criteria for a PR according to RECIST
1.1 criteria. Following identification of a dose-limiting toxicity
(DLT) in September 2021, the study proceeded to a dose
de-escalation portion and subsequently declared dose level 3 (1x108
cells/m2 following lymphodepletion) the recommended Phase 2 dose
(RP2D).
- Enrollment and treatment in the
Phase 2 expansion portion of the gavo-cel Phase 1/2 clinical trial
is ongoing.
- TCR2 presented new preclinical data
at The Society for Immunotherapy of Cancer’s (SITC) 37th Annual
Meeting demonstrating gavo-cel maintained effector function to
clear tumors and was not impaired, blocked or disrupted by
functional suppression from supraphysiological levels of soluble
mesothelin-related peptides.
TC-510:
• Enrollment and treatment in the Phase 1
dose escalation portion of the TC-510 Phase 1/2 clinical trial is
ongoing.
Financial Highlights
- Cash Position:
TCR2 ended the third quarter of 2022 with $176.0 million in cash,
cash equivalents, and investments compared to $265.6 million as of
December 31, 2021. Net cash used in operations was $25.8 million
for the third quarter of 2022 compared to $19.4 million for the
third quarter of 2021. TCR2 continues to project net cash use of
$115-125 million for 2022. We expect cash on hand to support
operations into 2024.
- R&D Expenses:
Research and development expenses were $24.8 million for the third
quarter of 2022 compared to $20.3 million for the third quarter of
2021. The increase in R&D expenses was primarily due to an
increase in clinical trial expenses associated with patient
treatment and product manufacturing.
- G&A Expenses:
General and administrative expenses were $6.3 million for the third
quarter of 2022 compared to $6.0 million for the third quarter of
2021. The slight increase in general and administrative expenses
was due to an increase supporting corporate activities.
- Net Loss: Net loss
was $30.6 million for the third quarter of 2022 compared to $26.2
million for the third quarter of 2021.
Upcoming Events
TCR2 Therapeutics management is scheduled to
participate at the following upcoming conferences.
- Jefferies London Healthcare Conference: Garry Menzel, President
and Chief Executive Officer of TCR2 Therapeutics, will present an
update on Company progress on Tuesday, November 15, 2022 at 5:35pm
GMT (12:35pm ET)
About TCR2
Therapeutics
TCR2 Therapeutics Inc. is a
clinical-stage cell therapy company developing a pipeline of novel
T cell therapies for cancer patients suffering from solid
tumors. The company is focused on the discovery and
development of product candidates against novel and complex targets
utilizing its proprietary T cell receptor (TCR) Fusion
Construct T cells (TRuC®-T cells). The TRuC platform is
designed to specifically recognize and kill cancer cells by
harnessing signaling from the entire TCR, independent of human
leukocyte antigens (HLA). For more information about TCR2, please
visit www.tcr2.com.
About gavo-cel
Gavo-cel is a mesothelin-targeted TRuC-T cell.
The ongoing gavo-cel Phase 1/2 clinical trial is evaluating the
safety and efficacy of gavo-cel in patients with
mesothelin-expressing malignant pleural/peritoneal mesothelioma
(MPM), ovarian cancer, non-small cell lung cancer (NSCLC) and
cholangiocarcinoma.
About TC-510
TC-510 is a mesothelin-targeted TRuC-T cell that
co-expresses a PD-1:CD28 chimeric switch receptor to provide a
local costimulatory signal by engaging with PD-L1 expressed in the
hostile tumor microenvironment and converting the negative
inhibitory signal into a positive costimulatory signal.
Forward-looking Statements
This press release contains forward-looking
statements and information within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended, and other
federal securities laws. The use of words such as "will,"
"expects," "plans," "believes," "predicts," "projects," "aims,"
"allows," “promising,” or the negative of such words or other
similar expressions can be used to identify forward-looking
statements. These forward-looking statements include, but are not
limited to, statements regarding TCR2’s plans, strategies,
timelines, and expectations for its gavo-cel and TC-510 clinical
trials, statements regarding IND-enabling studies on TC-520,
express or implied statements regarding the therapeutic potential
of gavo-cel, TC-510 and TCR2’s other product candidates in treating
cancer patients and improving access to investigational therapies
for cancer, and statements regarding expected cash use in 2022 and
cash runway into 2024.
The expressed or implied forward-looking
statements included in this press release are only current
expectations, beliefs, and predictions and are subject to a number
of risks, uncertainties, assumptions and important factors,
including, without limitation: uncertainties inherent in clinical
studies and in the availability and timing of data from ongoing
clinical studies; whether interim results from a clinical trial
will be predictive of the final results of the trial; whether
results from preclinical studies or earlier clinical studies will
be predictive of the results of future trials; the expected timing
of submissions for regulatory approval or review by governmental
authorities, including review under accelerated approval processes;
orphan drug designation eligibility; regulatory approvals to
conduct trials or to market products; TCR2’s ability to maintain
sufficient manufacturing capabilities to support its research,
development and commercialization efforts, including TCR2’s ability
to secure manufacturing capacity; whether TCR2's cash resources
will be sufficient to fund TCR2's foreseeable and unforeseeable
operating expenses and capital expenditure requirements, the impact
of the COVID-19 pandemic on TCR2’s ongoing operations; and other
risks set forth under the caption "Risk Factors" in TCR2’s most
recent Annual Report on Form 10-K, most recent Quarterly Report on
Form 10-Q and its other filings with the Securities and Exchange
Commission. In light of these risks, uncertainties, assumptions and
important factors, the forward-looking events and circumstances
discussed in this press release may not occur and actual results
could differ materially and adversely from those expressed or
implied in the forward-looking statements. You should not rely upon
forward-looking statements as predictions of future events.
Although TCR2believes that the expectations reflected in the
forward-looking statements are reasonable, it cannot guarantee that
the future results, levels of activity, performance or events and
circumstances reflected in the forward-looking statements will be
achieved or occur.
Moreover, except as required by law, neither
TCR2 nor any other person assumes responsibility for the accuracy
and completeness of the forward-looking statements included in this
press release. Any forward-looking statement included in this press
release speaks only as of the date on which it was made. We
undertake no obligation to publicly update or revise any
forward-looking statement, whether as a result of new information,
future events or otherwise, except as required by law.
Investor and Media Contact:
Carl Mauch Senior Director, Investor Relations
and Corporate Communications (617) 949-5667 carl.mauch@tcr2.com
TCR2
THERAPEUTICS INC. UNAUDITED CONSOLIDATED
BALANCE SHEETS (amounts in thousands, except share
data)
|
September 30, 2022 |
|
|
December 31, 2021 |
|
Assets |
|
|
|
|
|
Current
assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
54,006 |
|
|
$ |
222,564 |
|
Investments |
|
121,980 |
|
|
|
43,029 |
|
Prepaid expenses and other current assets |
|
8,093 |
|
|
|
10,534 |
|
Total current assets |
|
184,079 |
|
|
|
276,127 |
|
|
|
|
|
|
|
Property and equipment, net |
|
29,083 |
|
|
|
17,075 |
|
Right-of-use assets, operating leases |
|
57,704 |
|
|
|
28,283 |
|
Restricted cash |
|
1,152 |
|
|
|
1,156 |
|
Other assets, non-current |
|
909 |
|
|
|
730 |
|
Total assets |
$ |
272,927 |
|
|
$ |
323,371 |
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
Accounts payable |
$ |
2,963 |
|
|
$ |
2,144 |
|
Accrued expenses and other current liabilities |
|
13,185 |
|
|
|
13,094 |
|
Operating lease liabilities |
|
20,545 |
|
|
|
3,367 |
|
Total current liabilities |
|
36,693 |
|
|
|
18,605 |
|
|
|
|
|
|
|
Operating lease liabilities, non-current |
|
37,684 |
|
|
|
22,996 |
|
Other liabilities |
|
- |
|
|
|
293 |
|
Total liabilities |
|
74,377 |
|
|
|
41,894 |
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
Common stock, $0.0001 par value; 150,000,000 shares authorized;
38,657,061 and 38,496,484 shares issued and outstanding as of
September 30, 2022 and December 31, 2021, respectively. |
|
4 |
|
|
|
4 |
|
Additional paid-in capital |
|
639,981 |
|
|
|
631,008 |
|
Accumulated other comprehensive income (loss) |
|
(596 |
) |
|
|
(13 |
) |
Accumulated deficit |
|
(440,839 |
) |
|
|
(349,522 |
) |
Total stockholders’ equity |
|
198,550 |
|
|
|
281,477 |
|
Total liabilities and stockholders’ equity |
$ |
272,927 |
|
|
$ |
323,371 |
|
|
|
|
|
|
|
|
|
TCR2
THERAPEUTICS INC. UNAUDITED CONSOLIDATED
STATEMENTS OF OPERATIONS (amounts in thousands, except
share and per share data)
|
Three Months Ended
September 30, |
|
|
Nine Months Ended
September 30, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
24,791 |
|
|
$ |
20,277 |
|
|
$ |
73,441 |
|
|
$ |
54,828 |
|
General and administrative |
|
6,312 |
|
|
|
5,963 |
|
|
|
18,636 |
|
|
|
17,297 |
|
Total operating expenses |
|
31,103 |
|
|
|
26,240 |
|
|
|
92,077 |
|
|
|
72,125 |
|
Loss from operations |
|
(31,103 |
) |
|
|
(26,240 |
) |
|
|
(92,077 |
) |
|
|
(72,125 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
510 |
|
|
|
38 |
|
|
|
925 |
|
|
|
186 |
|
Loss before
income tax expense |
|
(30,593 |
) |
|
|
(26,202 |
) |
|
|
(91,152 |
) |
|
|
(71,939 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
1 |
|
|
|
42 |
|
|
|
165 |
|
|
|
129 |
|
Net
loss |
$ |
(30,594 |
) |
|
$ |
(26,244 |
) |
|
$ |
(91,317 |
) |
|
$ |
(72,068 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Per share
information |
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share of common stock, basic and diluted |
$ |
(0.79 |
) |
|
$ |
(0.69 |
) |
|
$ |
(2.37 |
) |
|
$ |
(1.91 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares outstanding, basic and diluted |
|
38,620,751 |
|
|
|
38,197,929 |
|
|
|
38,567,331 |
|
|
|
37,816,345 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TCR2
THERAPEUTICS INC. UNAUDITED CONSOLIDATED
STATEMENTS OF CASH FLOWS (amounts in thousands)
|
Nine Months Ended September 30, |
|
|
2022 |
|
|
2021 |
|
Operating activities |
|
|
|
|
|
Net loss |
$ |
(91,317 |
) |
|
$ |
(72,068 |
) |
Adjustments to reconcile net loss to cash used in operating
activities: |
|
|
|
|
|
Depreciation and amortization |
|
2,300 |
|
|
|
1,976 |
|
Stock-based compensation expense |
|
8,717 |
|
|
|
9,525 |
|
(Accretion) / Amortization on investments |
|
(403 |
) |
|
|
626 |
|
Deferred tax liabilities |
|
(293 |
) |
|
|
105 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
Prepaid expenses and other current assets |
|
2,618 |
|
|
|
(41 |
) |
Operating leases, net |
|
2,445 |
|
|
|
(2,811 |
) |
Accounts payable |
|
(637 |
) |
|
|
2,066 |
|
Accrued expenses and other liabilities |
|
66 |
|
|
|
2,299 |
|
Cash used in operating activities |
|
(76,504 |
) |
|
|
(58,323 |
) |
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
Purchases of equipment |
|
(12,681 |
) |
|
|
(4,352 |
) |
Software development costs |
|
(330 |
) |
|
|
(308 |
) |
Purchases of investments |
|
(215,619 |
) |
|
|
(40,732 |
) |
Proceeds from sale or maturity of investments |
|
136,488 |
|
|
|
140,622 |
|
Cash provided by (used in) investing activities |
|
(92,142 |
) |
|
|
95,230 |
|
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
Proceeds from public offering of common stock, net of issuance
costs |
|
- |
|
|
|
131,330 |
|
Proceeds from the exercise of stock options |
|
256 |
|
|
|
1,013 |
|
Payment of deferred offering costs |
|
(172 |
) |
|
|
(336 |
) |
Cash provided by financing activities |
|
84 |
|
|
|
132,007 |
|
|
|
|
|
|
|
Net
change in cash, cash equivalents, and restricted cash |
|
(168,562 |
) |
|
|
168,914 |
|
Cash, cash
equivalents, and restricted cash at beginning of year |
|
223,720 |
|
|
|
94,738 |
|
Cash, cash equivalents, and restricted cash at end of
period |
$ |
55,158 |
|
|
$ |
263,652 |
|
TCR2 Therapeutics (NASDAQ:TCRR)
Historical Stock Chart
From Jun 2024 to Jul 2024
TCR2 Therapeutics (NASDAQ:TCRR)
Historical Stock Chart
From Jul 2023 to Jul 2024