TCR² Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Corporate Update
11 March 2021 - 10:45PM
TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell
therapy company with a pipeline of novel T cell therapies for
patients suffering from cancer, today announced financial results
for the fourth quarter ended December 31, 2020 and provided a
corporate update.
“2020 was a transformative year for TCR2, with
initial clinical data on our lead program, gavo-cel, establishing
our leadership position in solid tumors. On the back of encouraging
RECIST responses in refractory mesothelioma and ovarian cancer, we
were able to strengthen our balance sheet and diversify our
investor base, extending our cash runway into 2024 to support our
goal of saving the lives of cancer patients,” said Garry Menzel,
Ph.D., President and Chief Executive Officer of
TCR2 Therapeutics. “We now look to accelerate the development
of gavo-cel in 2021 by identifying the recommended Phase 2 dose,
initiating the expansion portion of the trial and increasing our
manufacturing capacity. We will also provide updates on our rapidly
growing pipeline, most immediately with preclinical data
presentations at the AACR conference on our allogeneic mesothelin
TRuC and our CD70 autologous TRuC.”
Recent Developments
- TCR2 reported a
38% Overall Response Rate with three RECIST partial responses (PRs)
(2 confirmed and 1 unconfirmed PRs) from patients in the dose
escalation portion of the gavo-cel Phase 1/2 clinical trial,
including the first ovarian cancer patient to ever achieve a PR
with an engineered cell therapy and one mesothelioma patient
achieving a complete metabolic response.
- TCR2 completed
an upsized $140M follow-on offering.
- TCR2 announced
preliminary safety and efficacy data with a focus on translational
data of gavo-cel in patients with treatment refractory mesothelin
overexpressing solid tumors will be presented in an e-poster
presentation at the American Association of Cancer Research (AACR)
Virtual Annual Meeting on Saturday, April 10, 2021.
- TCR2 continues
to treat patients in the dose escalation portion of the TC-110
Phase 1/2 clinical trial.
- TCR2 announced
new preclinical data from its allogeneic TRuC-T cell targeting
mesothelin highlighting a lack of alloreactivity, reduced risk of
host rejection, upregulation of activation markers, secretion of
cytokines and clearance of tumors cells will be presented in an
e-poster presentation at the AACR Virtual Annual Meeting on
Saturday, April 10, 2021.
- TCR2 announced
new preclinical data from its TRuC-T cell targeting CD70
highlighting T cell expansion, improved memory phenotype,
significant anti-tumor efficacy in multiple xenograft mouse models
with no evidence of in vivo fratricide will be presented in an
e-poster presentation at the AACR Virtual Annual Meeting on
Saturday, April 10, 2021.
- TCR2 announced
the appointment of Shawn Tomasello to its Board of Directors. Ms.
Tomasello served as Chief Commercial Officer of Kite Pharma where
she oversaw the global commercialization of Yescarta, from 2015 to
2018 including through its acquisition by Gilead for $11.9 billion
in October 2017.
Anticipated Milestones
- TCR2 to present additional safety,
efficacy and translational data from the Phase 1 portion of the
gavo-cel Phase 1/2 clinical trial for patients with
mesothelin-expressing solid tumors throughout 2021.
- TCR2 to present an interim update
from the Phase 1 portion of the TC-110 Phase 1/2 clinical trial for
patients with CD19+ non-Hodgkin lymphoma or adult acute
lymphoblastic leukemia in 2021.
- TCR2 plans to file an IND for
TC-510, the first enhanced TRuC-T cell targeting mesothelin with a
PD-1:CD28 switch, in 2021.
- TCR2 plans to select a development
candidate for its allogeneic program in 2021.
- TCR2 anticipates additional
pipeline updates throughout 2021.
- TCR2 anticipates production of
gavo-cel clinical trial material from ElevateBio in 2021.
- TCR2 anticipates MHRA certification
of its manufacturing facility in Stevenage, UK, in mid-2021.
Financial Highlights
- Cash Position:
TCR2 ended 2020 with $228.0 million in cash, cash equivalents, and
investments compared to $158.1 million as of December 31, 2019.
Year-end 2020 cash balance does not reflect gross proceeds of $140
million from our equity offering in January. Net cash used in
operations was $56.7 million for 2020 compared to $41.4 million for
2019. TCR2 projects net cash use of $80-90 million for 2021.
- R&D Expenses:
Research and development expenses were $52.0 million for 2020
compared to $37.5 million for 2019. The increase in R&D
expenses is primarily related to increase in headcount, activities
related to the Phase 1/2 clinical trial of gavo-cel and activities
related to the Phase 1/2 clinical trial of TC-110.
- G&A Expenses:
General and administrative expenses were $16.7 million for 2020
compared to $13.9 million for 2019. The increase in general and
administrative expenses was primarily due to an increase in
personnel costs.
- Net Loss: Net loss
was $67.1 million for 2020 compared to $47.6 million for 2019,
driven predominantly by increased personnel expenses.
About TCR2
Therapeutics
TCR2 Therapeutics Inc. is a
clinical-stage cell therapy company developing a pipeline of novel
T cell therapies for patients suffering from solid tumors or
hematological malignancies. TCR2’s proprietary T cell
receptor (TCR) Fusion Construct T cells (TRuC®-T cells)
specifically recognize and kill cancer cells by harnessing
signaling from the entire TCR, independent of human leukocyte
antigens (HLA). In preclinical studies, TRuC-T cells have
demonstrated superior anti-tumor activity compared to chimeric
antigen receptor T cells (CAR-T cells), while secreting lower
levels of cytokine release. The Company’s lead TRuC-T cell product
candidate targeting solid tumors, gavo-cel, is currently being
studied in a Phase 1/2 clinical trial to treat patients with
mesothelin-positive non-small cell lung cancer (NSCLC), ovarian
cancer, malignant pleural/peritoneal mesothelioma, and
cholangiocarcinoma. The Company’s lead TRuC-T cell product
candidate targeting hematological malignancies, TC-110, is
currently being studied in a Phase 1/2 clinical trial to treat
patients with CD19-positive adult acute lymphoblastic leukemia
(aALL) and with aggressive or indolent non-Hodgkin lymphoma (NHL).
For more information about TCR2, please
visit www.tcr2.com.
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, timing for interim updates for the gavo-cel
and TC-110 clinical trials and announcement of additional
preclinical data, timing for the certification of our manufacturing
facility in Stevenage, UK, increased manufacturing capacity and
technical capabilities, including relating to our manufacturing
partnership with ElevateBio, LLC, increased clinical trial demand,
future IND filings and clinical development plans, 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 additional manufacturing facilities; 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 MauchDirector, Investor Relations and
Corporate Communications(617) 949-5667carl.mauch@tcr2.com
TCR2
THERAPEUTICS INC.UNAUDITED CONSOLIDATED
BALANCE SHEETS(amounts in thousands, except share
data)
|
December 31, |
|
|
2020 |
|
|
2019 |
|
Assets |
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
94,155 |
|
|
$ |
65,296 |
|
Investments |
|
133,831 |
|
|
|
92,828 |
|
Prepaid expenses and other current assets |
|
7,552 |
|
|
|
5,061 |
|
Total current assets |
|
235,538 |
|
|
|
163,185 |
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
10,013 |
|
|
|
4,926 |
|
Restricted cash |
|
583 |
|
|
|
417 |
|
Deferred offering costs |
|
61 |
|
|
|
- |
|
Total assets |
$ |
246,195 |
|
|
$ |
168,528 |
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
Accounts payable |
$ |
2,448 |
|
|
$ |
2,483 |
|
Accrued expenses and other current liabilities |
|
6,392 |
|
|
|
5,050 |
|
Total current liabilities |
|
8,840 |
|
|
|
7,533 |
|
|
|
|
|
|
|
|
|
Other liabilities |
|
807 |
|
|
|
546 |
|
Total liabilities |
|
9,647 |
|
|
|
8,079 |
|
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
|
Common stock, $0.0001 par value; 150,000,000 shares authorized;
33,516,795 and 24,050,936 shares issued; 33,516,795 and 23,981,109
shares outstanding at December 31, 2020 and 2019,
respectively. |
|
3 |
|
|
|
2 |
|
Additional paid-in capital |
|
486,197 |
|
|
|
342,896 |
|
Accumulated other comprehensive income |
|
63 |
|
|
|
142 |
|
Accumulated deficit |
|
(249,715 |
) |
|
|
(182,591 |
) |
Total stockholders’ equity |
|
236,548 |
|
|
|
160,449 |
|
Total liabilities and stockholders’ equity |
$ |
246,195 |
|
|
$ |
168,528 |
|
TCR2
THERAPEUTICS INC.UNAUDITED CONSOLIDATED
STATEMENTS OF OPERATIONS(amounts in thousands, except
share and per share data)
|
|
Three Months
EndedDecember 31, |
|
|
Twelve Months
EndedDecember 31, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
14,298 |
|
|
$ |
9,392 |
|
|
$ |
51,980 |
|
|
$ |
37,488 |
|
General and administrative |
|
|
4,269 |
|
|
|
4,179 |
|
|
|
16,720 |
|
|
|
13,894 |
|
Total operating expenses |
|
|
18,567 |
|
|
|
13,571 |
|
|
|
68,700 |
|
|
|
51,382 |
|
Loss from operations |
|
|
(18,567 |
) |
|
|
(13,571 |
) |
|
|
(68,700 |
) |
|
|
(51,382 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
191 |
|
|
|
846 |
|
|
|
1,737 |
|
|
|
3,885 |
|
Loss before income tax
expense |
|
|
(18,376 |
) |
|
|
(12,725 |
) |
|
|
(66,963 |
) |
|
|
(47,497 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
|
75 |
|
|
|
102 |
|
|
|
161 |
|
|
|
102 |
|
Net loss |
|
|
(18,451 |
) |
|
|
(12,827 |
) |
|
|
(67,124 |
) |
|
|
(47,599 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accretion of redeemable
convertible preferred stock to redemption value |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
$ |
(49,900 |
) |
Net loss attributable to common
stockholders |
|
$ |
(18,451 |
) |
|
$ |
(12,827 |
) |
|
$ |
(67,124 |
) |
|
$ |
(97,499 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Per share information |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of common
stock, basic and diluted |
|
$ |
(0.55 |
) |
|
$ |
(0.54 |
) |
|
$ |
(2.40 |
) |
|
$ |
(4.62 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding, basic and diluted |
|
|
33,448,315 |
|
|
|
23,961,960 |
|
|
|
27,990,564 |
|
|
|
21,104,195 |
|
TCR2
THERAPEUTICS INC.UNAUDITED CONSOLIDATED
STATEMENTS OF CASH FLOWS(amounts in thousands)
|
Twelve Months Ended December 31, |
|
|
2020 |
|
|
2019 |
|
Operating activities |
|
|
|
|
|
|
|
Net loss |
$ |
(67,124 |
) |
|
$ |
(47,599 |
) |
Adjustments to reconcile net loss to cash used in operating
activities: |
|
|
|
|
|
|
|
Depreciation and amortization |
|
1,592 |
|
|
|
862 |
|
Stock-based compensation expense |
|
8,492 |
|
|
|
6,702 |
|
Accretion on investments |
|
(702 |
) |
|
|
(225 |
) |
Deferred tax liabilities |
|
131 |
|
|
|
- |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
(1,101 |
) |
|
|
(3,057 |
) |
Accounts payable |
|
451 |
|
|
|
(179 |
) |
Accrued expenses and other liabilities |
|
1,522 |
|
|
|
2,137 |
|
Cash used in operating activities |
|
(56,739 |
) |
|
|
(41,359 |
) |
|
|
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
|
|
Purchases of equipment |
|
(7,164 |
) |
|
|
(3,879 |
) |
Purchases of investments |
|
(152,812 |
) |
|
|
(126,261 |
) |
Proceeds from sale or maturity of investments |
|
111,041 |
|
|
|
109,725 |
|
Cash used in investing activities |
|
(48,935 |
) |
|
|
(20,415 |
) |
|
|
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
|
|
Proceeds from public offering of common stock, net of issuance
costs |
|
133,571 |
|
|
|
79,132 |
|
Proceeds from the exercise of stock options |
|
1,189 |
|
|
|
391 |
|
Deferred offering costs |
|
(61 |
) |
|
|
- |
|
Cash provided by financing activities |
|
134,699 |
|
|
|
79,523 |
|
|
|
|
|
|
|
|
|
Net change in cash, cash
equivalents, and restricted cash |
|
29,025 |
|
|
|
17,749 |
|
Cash, cash equivalents, and
restricted cash at beginning of year |
|
65,713 |
|
|
|
47,964 |
|
Cash, cash equivalents, and
restricted cash at end of period |
$ |
94,738 |
|
|
$ |
65,713 |
|
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