TCR² Therapeutics Reports Second Quarter 2022 Financial Results and Provides Corporate Update
August 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 second quarter ended June 30, 2022 and
provided a corporate update.
"TCR2 made significant strides this quarter in
preparation for our upcoming gavo-cel Phase 1 and TC-510 data
expected in the second half of 2022. As part of our commitment to
deliver a meaningfully interpretable dataset, we plan to present
our gavo-cel Phase 1 trial data on at least 30 patients in
September in order to collect additional scans on patients
evaluable for efficacy," said Garry Menzel, Ph.D., President and
Chief Executive Officer of TCR2 Therapeutics. "We also continue to
expect to present initial safety, efficacy and translational data
from our TC-510 Phase 1 clinical trial before the end of 2022. In
connection with progressing our two mesothelin-focused clinical
trials, we have activated additional clinical sites and expanded
our manufacturing capacity through ElevateBio BaseCamp. This will
allow us to further accelerate the pace at which we can deliver our
unique cell therapy to benefit patients suffering from solid
tumors."
Recent Developments
TC-510:
- TCR2 initiated the Phase 1 dose
escalation portion of the Phase 1/2 clinical trial of TC-510, its
first enhanced mesothelin-targeted TRuC-T cell that co-expresses a
PD-1:CD28 chimeric switch receptor. Enrollment is ongoing and the
Company expects to report on initial safety, efficacy and
translational data from at least one of the Phase 1 dose escalation
cohorts of the Phase 1/2 clinical trial in the second half of
2022.
Corporate:
- TCR2 announced the
appointment of industry and finance veteran Eric Sullivan as Chief
Financial Officer where he will be responsible for leading all
aspects of financial management and capital market strategy as well
as overseeing investor relations and select business
operations.
Manufacturing:
- TCR2 announced
today the commencement of clinical trial material production at
ElevateBio BaseCamp in anticipation of increased demand from the
Phase 2 expansion trial of gavo-cel.
Anticipated Milestones
Gavo-cel:
- Present the
expanded Phase 1 dataset for gavo-cel in September 2022.
- Provide an update
from the Phase 2 portion of the ongoing gavo-cel Phase 1/2 clinical
trial in the second half of 2022.
TC-510:
- Report initial
safety, efficacy and translational data from at least one of the
Phase 1 dose escalation cohorts of the TC-510 Phase 1/2 clinical
trial in the second half of 2022.
Pipeline:
- Initiate
IND-enabling studies for TC-520, an enhanced CD70 targeting TRuC-T
cell program, in 2022.
Financial Highlights
- Cash Position:
TCR2 ended the second quarter of 2022 with $206.2 million in cash,
cash equivalents, and investments compared to $265.6 million as of
December 31, 2021. Net cash used in operations was $19.5 million
for the second quarter of 2022 compared to $15.0 million for the
second quarter of 2021. TCR2 projects 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 $25.8 million for the second
quarter of 2022 compared to $18.6 million for the second quarter of
2021. The increase in R&D expenses was primarily due to an
increase in contract manufacturing costs and clinical trial
expenses associated with patient treatment and headcount.
- G&A Expenses:
General and administrative expenses were $6.0 million for the
second quarter of 2022 compared to $5.7 million for the second
quarter of 2021. The increase in general and administrative
expenses was due to an increase in personnel costs and other
professional fees.
- Net Loss: Net loss
was $31.6 million for the second quarter of 2022 compared to $24.3
million for the second quarter of 2021.
Upcoming Events
TCR2 Therapeutics management is scheduled to
participate at the following upcoming conferences.
- Wedbush PacGrow
Healthcare Conference: Management will participate in investor
one-on-one meetings on August 10, 2022
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.
The TC-510 Phase 1/2 clinical trial is
evaluating the safety and efficacy of TC-510 in patients with
mesothelin-expressing MPM, ovarian cancer, pancreatic cancer,
colorectal cancer and triple negative breast cancer.
Forward-looking Statements
This press release contains forward-looking
statements and information within the meaning of the Private
Securities Litigation Reform Act of 1995 and other federal
securities laws. The use of words such as "may," "will," "could",
"should," "expects," "intends," "plans," "anticipates," "believes,"
"estimates," "predicts," "projects," "seeks," "endeavor,"
"potential," "continue" 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, express or implied statements regarding the therapeutic
potential of gavo-cel, TC-510 and the Company’s other product
candidates, expected progress and timing of updates for the
gavo-cel and TC-510 clinical trials, expectations regarding
clinical data for gavo-cel and TC-510 and the timing of an IND
submission for TC-520, expectations with respect to manufacturing
capacity and technical capabilities, including through the
Company’s manufacturing partnership with ElevateBio, LLC,
expectations with respect to clinical trial demand, future
IND-enabling studies and filings, future clinical development
plans, expected cash use in 2022 and cash runway into 2024,
expectations regarding the development of the Company’s TRuC-T
cells, their potential characteristics, applications and clinical
utility, and the potential therapeutic applications of the
Company’s TRuC-T cell platform.
The expressed or implied forward-looking statements
included in this press release are only predictions and are subject
to a number of risks, uncertainties and assumptions, 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 and assumptions, the
forward-looking events and circumstances discussed in this press
release may not occur and actual results could differ materially
and adversely from those anticipated or implied in the
forward-looking statements. You should not rely upon
forward-looking statements as predictions of future events.
Although TCR2 believes 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 MauchSenior Director, Investor Relations
and Corporate Communications(617) 949-5667carl.mauch@tcr2.com
TCR2
THERAPEUTICS INC.UNAUDITED CONSOLIDATED
BALANCE SHEETS(amounts in thousands, except share
data)
|
June 30,2022 |
|
|
December 31,2021 |
|
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
44,211 |
|
|
$ |
222,564 |
|
Investments |
|
162,027 |
|
|
|
43,029 |
|
Prepaid expenses and other current assets |
|
9,592 |
|
|
|
10,534 |
|
Total current assets |
|
215,830 |
|
|
|
276,127 |
|
|
|
|
|
|
|
Property and equipment, net |
|
27,712 |
|
|
|
17,075 |
|
Right-of-use assets, operating leases |
|
62,293 |
|
|
|
28,283 |
|
Restricted cash |
|
1,152 |
|
|
|
1,156 |
|
Other assets, non-current |
|
1,057 |
|
|
|
730 |
|
Total assets |
$ |
308,044 |
|
|
$ |
323,371 |
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
Accounts payable |
$ |
5,470 |
|
|
$ |
2,144 |
|
Accrued expenses and other current liabilities |
|
12,528 |
|
|
|
13,094 |
|
Operating lease liabilities |
|
20,574 |
|
|
|
3,367 |
|
Total current liabilities |
|
38,572 |
|
|
|
18,605 |
|
|
|
|
|
|
|
Operating lease liabilities, non-current |
|
43,209 |
|
|
|
22,996 |
|
Other liabilities |
|
- |
|
|
|
293 |
|
Total liabilities |
|
81,781 |
|
|
|
41,894 |
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
Common stock, $0.0001 par value; 150,000,000 shares authorized;
38,598,916 and 38,496,484 shares issued and outstanding as of June
30, 2022 and December 31, 2021, respectively. |
|
4 |
|
|
|
4 |
|
Additional paid-in capital |
|
637,175 |
|
|
|
631,008 |
|
Accumulated other comprehensive income (loss) |
|
(671 |
) |
|
|
(13 |
) |
Accumulated deficit |
|
(410,245 |
) |
|
|
(349,522 |
) |
Total stockholders’ equity |
|
226,263 |
|
|
|
281,477 |
|
Total liabilities and stockholders’ equity |
$ |
308,044 |
|
|
$ |
323,371 |
|
|
|
|
|
|
|
|
|
TCR2
THERAPEUTICS INC.UNAUDITED CONSOLIDATED
STATEMENTS OF OPERATIONS(amounts in thousands, except
share and per share data)
|
|
Three Months
EndedJune 30, |
|
|
Six Months
EndedJune 30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
25,767 |
|
|
$ |
18,627 |
|
|
$ |
48,650 |
|
|
$ |
34,551 |
|
General and administrative |
|
|
6,004 |
|
|
|
5,666 |
|
|
|
12,324 |
|
|
|
11,334 |
|
Total operating expenses |
|
|
31,771 |
|
|
|
24,293 |
|
|
|
60,974 |
|
|
|
45,885 |
|
Loss from operations |
|
|
(31,771 |
) |
|
|
(24,293 |
) |
|
|
(60,974 |
) |
|
|
(45,885 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
298 |
|
|
|
32 |
|
|
$ |
415 |
|
|
|
148 |
|
Loss before income tax
expense |
|
|
(31,473 |
) |
|
|
(24,261 |
) |
|
|
(60,559 |
) |
|
|
(45,737 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
|
128 |
|
|
|
51 |
|
|
$ |
164 |
|
|
|
87 |
|
Net loss |
|
$ |
(31,601 |
) |
|
$ |
(24,312 |
) |
|
$ |
(60,723 |
) |
|
$ |
(45,824 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Per share information |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of common
stock, basic and diluted |
|
$ |
(0.82 |
) |
|
$ |
(0.64 |
) |
|
$ |
(1.58 |
) |
|
$ |
(1.22 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding, basic and diluted |
|
|
38,566,954 |
|
|
|
38,176,025 |
|
|
|
38,540,178 |
|
|
|
37,622,390 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TCR2
THERAPEUTICS INC.UNAUDITED CONSOLIDATED
STATEMENTS OF CASH FLOWS(amounts in thousands)
|
Six Months Ended June 30, |
|
|
2022 |
|
|
2021 |
|
Operating
activities |
|
|
|
|
|
Net loss |
$ |
(60,723 |
) |
|
$ |
(45,824 |
) |
Adjustments to reconcile net loss to cash used in operating
activities: |
|
|
|
|
|
Depreciation and amortization |
|
1,410 |
|
|
|
1,203 |
|
Stock-based compensation expense |
|
6,024 |
|
|
|
6,339 |
|
(Accretion) / Amortization on investments |
|
(140 |
) |
|
|
417 |
|
Deferred tax liabilities |
|
(293 |
) |
|
|
63 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
Prepaid expenses and other current assets |
|
1,119 |
|
|
|
(490 |
) |
Operating leases, net |
|
3,410 |
|
|
|
(3,415 |
) |
Accounts payable |
|
(881 |
) |
|
|
2,587 |
|
Accrued expenses and other liabilities |
|
(591 |
) |
|
|
178 |
|
Cash used in operating activities |
|
(50,665 |
) |
|
|
(38,942 |
) |
|
|
|
|
|
|
Investing
activities |
|
|
|
|
|
Purchases of equipment |
|
(7,893 |
) |
|
|
(2,184 |
) |
Software development costs |
|
(295 |
) |
|
|
(128 |
) |
Purchases of investments |
|
(186,006 |
) |
|
|
(40,732 |
) |
Proceeds from sale or maturity of investments |
|
66,490 |
|
|
|
105,518 |
|
Cash provided by (used in) investing activities |
|
(127,704 |
) |
|
|
62,474 |
|
|
|
|
|
|
|
Financing
activities |
|
|
|
|
|
Proceeds from public offering of common stock, net of issuance
costs |
|
- |
|
|
|
131,330 |
|
Proceeds from the exercise of stock options |
|
143 |
|
|
|
580 |
|
Payment of deferred offering costs |
|
(131 |
) |
|
|
(246 |
) |
Cash provided by financing activities |
|
12 |
|
|
|
131,664 |
|
|
|
|
|
|
|
Net change in cash, cash
equivalents, and restricted cash |
|
(178,357 |
) |
|
|
155,196 |
|
Cash, cash equivalents, and
restricted cash at beginning of year |
|
223,720 |
|
|
|
94,738 |
|
Cash, cash equivalents,
and restricted cash at end of period |
$ |
45,363 |
|
|
$ |
249,934 |
|
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