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 first quarter ended March 31, 2021 and provided a corporate
update.
“We remain on track to identify the recommended
Phase 2 dose for gavo-cel in 2021 and advance into the expansion
portion of the Phase 1/2 trial where our primary focus will be
efficacy as well as continuing to monitor for safety. The clinical
benefit we have observed with our cancer patients gave us
confidence to expand our manufacturing capabilities by establishing
a commercial-scale cGMP facility in Rockville, Maryland, which we
expect to come online in 2023,” said Garry Menzel, Ph.D., President
and Chief Executive Officer of TCR2 Therapeutics. “In the last
quarter we were also able to showcase our early-stage programs in
our rich pipeline and reflect on the versatility of our TRuC-T cell
platform. This included presenting our CD70-targeted autologous
TRuC-T cell and our mesothelin-targeted allogeneic TRuC-T cell at
AACR. As for our additional solid tumor milestones in 2021, we
expect to present more complete data from the dose escalation
Phase 1 portion of the gavo-cel trial, file an IND for TC-510,
a mesothelin-targeted TRuC-T cell enhanced with a PD-1:CD28 switch
receptor, and present preclinical data on our IL-15 enhancement,
which we believe will drive even longer persistence and expression
of a memory phenotype, characteristics which could be beneficial
across our portfolio.”
Recent Developments
gavo-cel:
- TCR2 presented
clinical and translational data from the dose escalation portion of
the Company’s Phase 1/2 clinical trial of gavo-cel in patients with
treatment refractory mesothelin-expressing solid tumors at the
American Association for Cancer Research (AACR) Virtual Annual
Meeting. The data reported were from eight treatment-refractory
mesothelin-expressing solid tumor patients and highlighted
translational markers consistent with the clinical profile,
including transduction efficiency, CD4:CD8 ratio, memory phenotype,
expansion and persistence and cytokines.
Early-Stage Pipeline
- TCR2 presented
new preclinical data from its allogeneic “off the shelf” 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 comparable to
gavo-cel at the AACR Virtual Annual Meeting.
- TCR2 presented
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 at the AACR Virtual Annual
Meeting.
Corporate:
- TCR2 announced
that it signed a long-term, full-building lease with Alexandria
Real Estate Equities, Inc. (NYSE: ARE) for an existing 85,000
square foot cell therapy manufacturing facility in Rockville,
Maryland which is ready for Current Good Manufacturing Practice
(cGMP) build-out. The site will support clinical and commercial
production of gavo-cel with a capacity that is projected to treat
several thousand cancer patients annually. The facility is expected
to accelerate the Company’s commercial-scale manufacturing
timelines with production anticipated in 2023.
- TCR2 announced
the appointment of Aaron Vernon as Vice President of Technical
Operations. Previously, Mr. Vernon held senior positions including
Vice President of Global Technical Operations and Vice President of
Engineering & Supply Chain at Autolus Therapeutics, where he
led manufacturing capacity expansion and overseeing internal and
external manufacturing of plasmid, vector and cell therapy
products.
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 the second half of 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 the second half of 2021.
- TCR2 plans to select a development
candidate for its allogeneic program in the second half of
2021.
- TCR2 to present preclinical data on
its IL-15 enhancements program in the second half of 2021.
- TCR2 anticipates production of
clinical trial material from ElevateBio LLC and its manufacturing
facility in Stevenage, UK, both in anticipation of demand from the
Phase 2 expansion trial of gavo-cel, in 2022.
Financial Highlights
- Cash Position:
TCR2 ended the first quarter of 2021 with $333.3 million in cash,
cash equivalents, and investments compared to $228.0 million as of
December 31, 2020. Net cash used in operations was $19.9 million
for the first quarter of 2021 compared to $16.4 million for the
first quarter of 2020. TCR2 projects net cash use of $100-110
million for 2021, which includes tenant improvements to the
Rockville facility. We expect cash on hand to support operations
through 2023.
- R&D Expenses:
Research and development expenses were $15.9 million for the first
quarter of 2021 compared to $12.0 million for the first quarter of
2020. The increase in R&D expenses is primarily related to
ongoing clinical trials, increase in headcount and additional lab
facilities.
- G&A Expenses:
General and administrative expenses were $5.7 million for the first
quarter of 2021 compared to $4.3 million for the first quarter of
2020. The increase in general and administrative expenses was
primarily due to an increase in personnel costs.
- Net Loss: Net loss
was $21.5 million for the first quarter of 2021 compared to $15.5
million for the first quarter of 2020, driven predominantly by
increased personnel expenses.
Rockville Facility
In March 2021, we entered into a lease for a new manufacturing
facility. The landlord built an approximately 85,000 square foot
rental building in Rockville, Maryland and leased the facility to
the Company as a manufacturing facility for an initial term of 15
years through June 2036.
Because we are involved in the construction project and are
responsible for paying a significant portion of the costs of normal
finish work and structural elements of the facility, the Company is
deemed for accounting purposes to be the owner of the building
during the construction period under build to suit lease accounting
guidance under ASC 840, Leases. Therefore, the Company
recorded a construction-in-progress asset and a related
construction financing obligation on our consolidated balance
sheets as a component of property and equipment and lease financing
obligations, respectively. We anticipate lease payments of $1.4
million for the remainder of 2021.
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, timing for the certification of our
manufacturing facility in Stevenage, UK and Rockville, MD,
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)
|
March 31,2021 |
|
|
December 31,2020 |
|
Assets |
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
218,276 |
|
|
$ |
94,155 |
|
Investments |
|
115,005 |
|
|
|
133,831 |
|
Prepaid expenses and other current assets |
|
9,690 |
|
|
|
7,552 |
|
Total current assets |
|
342,971 |
|
|
|
235,538 |
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
51,842 |
|
|
|
10,013 |
|
Restricted cash |
|
1,141 |
|
|
|
583 |
|
Deferred offering costs |
|
225 |
|
|
|
61 |
|
Total assets |
$ |
396,179 |
|
|
$ |
246,195 |
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
Accounts payable |
$ |
3,830 |
|
|
$ |
2,448 |
|
Accrued expenses and other current liabilities |
|
4,577 |
|
|
|
6,392 |
|
Lease financing obligation |
|
2,114 |
|
|
|
- |
|
Total current liabilities |
|
10,521 |
|
|
|
8,840 |
|
|
|
|
|
|
|
|
|
Lease financing obligation, excluding current portion |
|
35,011 |
|
|
|
- |
|
Other liabilities |
|
892 |
|
|
|
807 |
|
Total liabilities |
|
46,424 |
|
|
|
9,647 |
|
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
|
Common stock, $0.0001 par value; 150,000,000 shares authorized;
38,159,202 and 24,050,936 shares issued; 38,159,202 and 23,981,109
shares outstanding at December 31, 2020 and 2019,
respectively. |
|
4 |
|
|
|
3 |
|
Additional paid-in capital |
|
621,022 |
|
|
|
486,197 |
|
Accumulated other comprehensive income |
|
(44 |
) |
|
|
63 |
|
Accumulated deficit |
|
(271,227 |
) |
|
|
(249,715 |
) |
Total stockholders’ equity |
|
349,755 |
|
|
|
236,548 |
|
Total liabilities and stockholders’ equity |
$ |
396,179 |
|
|
$ |
246,195 |
|
TCR2
THERAPEUTICS INC.UNAUDITED CONSOLIDATED
STATEMENTS OF OPERATIONS(amounts in thousands, except
share and per share data)
|
|
Three Months
EndedMarch 31, |
|
|
|
2021 |
|
|
2020 |
|
Operating expenses |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
15,924 |
|
|
$ |
11,955 |
|
General and administrative |
|
|
5,668 |
|
|
|
4,271 |
|
Total operating expenses |
|
|
21,592 |
|
|
|
16,226 |
|
Loss from operations |
|
|
(21,592 |
) |
|
|
(16,226 |
) |
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
116 |
|
|
|
747 |
|
Loss before income tax
expense |
|
|
(21,476 |
) |
|
|
(15,479 |
) |
|
|
|
|
|
|
|
|
|
Income tax expense |
|
|
36 |
|
|
|
27 |
|
Net loss |
|
$ |
(21,512 |
) |
|
$ |
(15,506 |
) |
|
|
|
|
|
|
|
|
|
Per share information |
|
|
|
|
|
|
|
|
Net loss per share of common
stock, basic and diluted |
|
$ |
(0.58 |
) |
|
$ |
(0.65 |
) |
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding, basic and diluted |
|
|
37,062,604 |
|
|
|
24,011,843 |
|
TCR2
THERAPEUTICS INC.UNAUDITED CONSOLIDATED
STATEMENTS OF CASH FLOWS(amounts in thousands)
|
Three Months Ended March 31, |
|
|
2021 |
|
|
2020 |
|
Operating activities |
|
|
|
|
|
|
|
Net loss |
$ |
(21,512 |
) |
|
$ |
(15,506 |
) |
Adjustments to reconcile net loss to cash used in operating
activities: |
|
|
|
|
|
|
|
Depreciation and amortization |
|
513 |
|
|
|
306 |
|
Stock-based compensation expense |
|
3,120 |
|
|
|
2,055 |
|
Accretion on investments |
|
164 |
|
|
|
(164 |
) |
Deferred tax liabilities |
|
36 |
|
|
|
- |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
(2,136 |
) |
|
|
(1,589 |
) |
Accounts payable |
|
1,684 |
|
|
|
603 |
|
Accrued expenses and other liabilities |
|
(1,767 |
) |
|
|
(2,115 |
) |
Cash used in operating activities |
|
(19,898 |
) |
|
|
(16,410 |
) |
|
|
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
|
|
Purchases of equipment |
|
(1,491 |
) |
|
|
(504 |
) |
Purchases of investments |
|
(40,732 |
) |
|
|
(47,956 |
) |
Proceeds from sale or maturity of investments |
|
59,287 |
|
|
|
30,617 |
|
Cash used in investing activities |
|
17,064 |
|
|
|
(17,843 |
) |
|
|
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
|
|
Proceeds from public offering of common stock, net of issuance
costs |
|
131,330 |
|
|
|
- |
|
Proceeds from the exercise of stock options |
|
376 |
|
|
|
185 |
|
Payments on lease financing obligation |
|
(4,029 |
) |
|
|
- |
|
Deferred offering costs |
|
(164 |
) |
|
|
(135 |
) |
Cash provided by financing activities |
|
127,513 |
|
|
|
50 |
|
|
|
|
|
|
|
|
|
Net change in cash, cash
equivalents, and restricted cash |
|
124,679 |
|
|
|
(34,203 |
) |
Cash, cash equivalents, and
restricted cash at beginning of year |
|
94,738 |
|
|
|
65,713 |
|
Cash, cash equivalents, and
restricted cash at end of period |
$ |
219,417 |
|
|
$ |
31,510 |
|
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