TCR² Therapeutics Reports Fourth Quarter 2021 Financial Results and Provides Corporate Update
March 22 2022 - 5:45AM
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 fourth quarter ended December 31, 2021
and provided a corporate update.
"Consistent execution throughout the last year
has positioned TCR2 for a series of important readouts as we
accelerate our clinical progress in 2022," said Garry Menzel,
Ph.D., President and Chief Executive Officer of TCR2 Therapeutics.
"We were able to successfully conclude the dose escalation portion
of our ongoing gavo-cel Phase 1/2 clinical trial with the
identification of a RP2D and submit a protocol amendment with the
FDA for the upcoming Phase 2 clinical trial. We also submitted an
IND with the FDA for our first enhanced TRuC-T cell that
incorporates a PD-1:CD28 switch. In the meantime, we have been
identifying new clinical trial sites and expanding manufacturing
capacity for the reproducible process used by Miltenyi and
ElevateBio to support our clinical trials. In addition to the
clinical readouts from gavo-cel and TC-510, we will continue to
provide updates on the innovations in our rapidly growing pipeline,
most immediately with a preclinical data presentation on our
allogeneic TRuC targeting mesothelin at the AACR Annual Meeting in
April."
Recent Developments
Gavo-cel:
- TCR2 announced the submission of a protocol amendment to the US
Food and Drug Administration (FDA) in the first quarter of 2022 for
the gavo-cel Phase 2 expansion cohort, including the amendment to
treat patients with gavo-cel in combination with Opdivo and/or
Yervoy which forms the basis of the Company’s clinical trial
collaboration with Bristol Myers Squibb.
TC-510:
- TCR2 announced the submission of an
Investigational New Drug (IND) to the FDA in the first quarter of
2022 for TC-510, the Company’s first enhanced TRuC-T cell targeting
mesothelin with a PD-1:CD28 chimeric switch receptor.
Pipeline:
- TCR2 announced it will present a poster at the American
Association of Cancer Research (AACR) Annual Meeting 2022 featuring
new preclinical data on an allogeneic (off-the-shelf) TRuC-T cell,
taking place on April 8-13, 2022 in New Orleans, Louisiana. In
preclinical studies, this allogeneic product candidate without an
enhancement demonstrated improved anti-tumor efficacy associated
with enhanced persistence and increased antigen sensitivity in vivo
compared to donor-matched autologous TRuC-T cells targeting
mesothelin. Furthermore, allogeneic TRuC-T cells generated with an
additional knockout of Beta-2-microglobulin (B2M) maintained their
potency.
- TCR2 announced a strategic research collaboration agreement
with Arbor Biotechnologies focused on the further development of a
defined set of allogeneic TRuC-T cell therapies. The collaboration
leverages Arbor's proprietary CRISPR gene-editing technology, which
is tailored to address the underlying pathology of genetic diseases
and TCR2's first-in-class TRuC platform, which has demonstrated
clinical activity in multiple treatment-refractory
mesothelin-expressing solid tumor indications with gavo-cel.
Corporate:
- TCR2 announced the appointment of
experienced biotech executive Rosemary Harrison, Ph.D., as Chief
Business and Strategy Officer where she will be responsible for
supporting a range of activities including commercial strategy,
operational planning, corporate partnerships and long-term growth
opportunities.
Anticipated Milestones
- Gavo-cel:
- Present the expanded and complete Phase 1 dataset for gavo-cel
in the second quarter of 2022.
- Initiate the Phase 2 expansion cohort of the ongoing gavo-cel
Phase 1/2 clinical trial in the first half of 2022.
- Provide an initial update from at least one of the Phase 2
expansion cohorts 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.
- Select a lead candidate for its allogeneic program in
2022.
- Manufacturing:
- Production of clinical trial
material to commence at ElevateBio BaseCamp as capacity is
increased in anticipation of demand from the Phase 2 expansion
trial of gavo-cel in 2022.
Financial Highlights
- Cash Position:
TCR2 ended the fourth quarter of 2021 with $265.6 million in cash,
cash equivalents, and investments compared to $228.0 million as of
December 31, 2020. Net cash used in operations was $23.3 million
for the fourth quarter of 2021 compared to $13.5 million for the
fourth quarter of 2020. 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 $22.4 million for the fourth
quarter of 2021 compared to $14.3 million for the fourth quarter of
2020. The research and development expenses for the fourth quarter
of 2021 include restructuring costs of $3.7 million and are
partially offset by a $2 million settlement from a vendor due to a
commercial dispute. The remaining increase in R&D expenses was
primarily due to an increase in headcount and manufacturing
facilities.
- G&A Expenses:
General and administrative expenses were $5.2 million for the
fourth quarter of 2021 compared to $4.3 million for the fourth
quarter of 2020. The increase in general and administrative
expenses was primarily due to an increase in personnel costs.
- Net Loss: Net loss was $27.7 million for the
fourth quarter of 2021 compared to $18.5 million for the fourth
quarter of 2020.
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.
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 with respect to
the FDA’s review of our gavo-cel protocol amendments, expectations
with respect to timing of our IND submission for TC-510,
expectations regarding clinical data for gavo-cel and TC-510 and
preclinical data for our emerging pipeline and enhancements,
increased manufacturing capacity and technical capabilities,
including through our manufacturing partnership with ElevateBio,
LLC, expectations with respect to increased clinical trial demand
and identification of additional clinical trial sites, future IND
filings and clinical development plans, expected cash use in 2022
and cash runway into 2024, 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 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)
|
December 31, 2021 |
|
|
December 31, 2020 |
|
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
222,564 |
|
|
$ |
94,155 |
|
Investments |
|
43,029 |
|
|
|
133,831 |
|
Prepaid expenses and other current assets |
|
10,534 |
|
|
|
7,552 |
|
Total current assets |
|
276,127 |
|
|
|
235,538 |
|
|
|
|
|
|
|
Property and equipment, net |
|
17,075 |
|
|
|
10,013 |
|
Right-of-use assets, operating leases |
|
28,283 |
|
|
|
- |
|
Restricted cash |
|
1,156 |
|
|
|
583 |
|
Other assets, non-current |
|
730 |
|
|
|
61 |
|
Total assets |
$ |
323,371 |
|
|
$ |
246,195 |
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
Accounts payable |
$ |
2,144 |
|
|
$ |
2,448 |
|
Accrued expenses and other current liabilities |
|
13,094 |
|
|
|
6,392 |
|
Operating lease liabilities |
|
3,367 |
|
|
|
- |
|
Total current liabilities |
|
18,605 |
|
|
|
8,840 |
|
|
|
|
|
|
|
Operating lease liabilities, non-current |
|
22,996 |
|
|
|
- |
|
Other liabilities |
|
293 |
|
|
|
807 |
|
Total liabilities |
|
41,894 |
|
|
|
9,647 |
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
Common stock, $0.0001 par value; 150,000,000 shares authorized;
38,496,484 and 33,516,795 shares issued and outstanding as of
December 31, 2021 and December 31, 2020, respectively. |
|
4 |
|
|
|
3 |
|
Additional paid-in capital |
|
631,008 |
|
|
|
486,197 |
|
Accumulated other comprehensive income (loss) |
|
(13 |
) |
|
|
63 |
|
Accumulated deficit |
|
(349,522 |
) |
|
|
(249,715 |
) |
Total stockholders’ equity |
|
281,477 |
|
|
|
236,548 |
|
Total liabilities and stockholders’ equity |
$ |
323,371 |
|
|
$ |
246,195 |
|
TCR2
THERAPEUTICS INC. UNAUDITED CONSOLIDATED
STATEMENTS OF OPERATIONS (amounts in thousands, except
share and per share data)
|
|
Three Months Ended
December 31, |
|
|
Twelve Months Ended
December 31, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
22,411 |
|
|
$ |
14,298 |
|
|
$ |
77,239 |
|
|
$ |
51,980 |
|
General and administrative |
|
|
5,206 |
|
|
|
4,269 |
|
|
|
22,503 |
|
|
|
16,720 |
|
Total operating expenses |
|
|
27,617 |
|
|
|
18,567 |
|
|
|
99,742 |
|
|
|
68,700 |
|
Loss from operations |
|
|
(27,617 |
) |
|
|
(18,567 |
) |
|
|
(99,742 |
) |
|
|
(68,700 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
38 |
|
|
|
191 |
|
|
|
224 |
|
|
|
1,737 |
|
Loss before income tax expense |
|
|
(27,579 |
) |
|
|
(18,376 |
) |
|
|
(99,518 |
) |
|
|
(66,963 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
|
160 |
|
|
|
75 |
|
|
|
289 |
|
|
|
161 |
|
Net loss |
|
$ |
(27,739 |
) |
|
$ |
(18,451 |
) |
|
$ |
(99,807 |
) |
|
$ |
(67,124 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Per share information |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of common stock, basic and diluted |
|
$ |
(0.72 |
) |
|
$ |
(0.55 |
) |
|
$ |
(2.63 |
) |
|
$ |
(2.40 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding, basic and diluted |
|
|
38,289,295 |
|
|
|
33,448,315 |
|
|
|
37,935,554 |
|
|
|
27,990,564 |
|
TCR2
THERAPEUTICS INC. UNAUDITED CONSOLIDATED
STATEMENTS OF CASH FLOWS (amounts in thousands)
|
Twelve Months Ended December 31, |
|
|
2021 |
|
|
2020 |
|
Operating activities |
|
|
|
|
|
Net loss |
$ |
(99,807 |
) |
|
$ |
(67,124 |
) |
Adjustments to reconcile net loss to cash used in operating
activities: |
|
|
|
|
|
Depreciation and amortization |
|
2,827 |
|
|
|
1,592 |
|
Asset impairment due to restructuring |
|
559 |
|
|
|
- |
|
Stock-based compensation expense |
|
12,265 |
|
|
|
8,492 |
|
Amortization (accretion) on investments |
|
837 |
|
|
|
(702 |
) |
Deferred tax liabilities |
|
99 |
|
|
|
131 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
Prepaid expenses and other current assets |
|
(2,496 |
) |
|
|
(1,101 |
) |
Operating leases, net |
|
(2,416 |
) |
|
|
- |
|
Accounts payable |
|
(771 |
) |
|
|
451 |
|
Accrued expenses and other liabilities |
|
7,300 |
|
|
|
1,522 |
|
Cash used in operating activities |
|
(81,603 |
) |
|
|
(56,739 |
) |
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
Purchases of equipment |
|
(11,098 |
) |
|
|
(7,164 |
) |
Software development costs |
|
(351 |
) |
|
|
- |
|
Purchases of investments |
|
(50,726 |
) |
|
|
(152,812 |
) |
Proceeds from sale or maturity of investments |
|
140,622 |
|
|
|
111,041 |
|
Cash provided by (used in) investing activities |
|
78,447 |
|
|
|
(48,935 |
) |
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
Proceeds from public offering of common stock, net of issuance
costs |
|
131,330 |
|
|
|
133,571 |
|
Proceeds from the exercise of stock options |
|
1,217 |
|
|
|
1,189 |
|
Payment of deferred offering costs |
|
(409 |
) |
|
|
(61 |
) |
Cash provided by financing activities |
|
132,138 |
|
|
|
134,699 |
|
|
|
|
|
|
|
Net change in cash, cash equivalents, and restricted
cash |
|
128,982 |
|
|
|
29,025 |
|
Cash, cash equivalents, and restricted cash at beginning of
year |
|
94,738 |
|
|
|
65,713 |
|
Cash, cash equivalents, and restricted cash at end of
period |
$ |
223,720 |
|
|
$ |
94,738 |
|
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