TCR² Therapeutics Reports Third Quarter 2021 Financial Results and Provides Corporate Update
November 10 2021 - 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, 2021
and provided a corporate update.
“Over the last few months, we continue to treat
cancer patients in our ongoing gavo-cel Phase 1 clinical trial and
have observed meaningful clinical benefit in three different
treatment-refractory solid tumor indications,” said Garry Menzel,
Ph.D., President and Chief Executive Officer of
TCR2 Therapeutics. “As we prepare for the phase 2 trial to be
launched in early 2022, we are expanding our US manufacturing
footprint and successfully negotiated a clinical trial
collaboration agreement with Bristol Myers Squibb, where we will
have the opportunity to evaluate the efficacy and duration of
gavo-cel in combination with Opdivo and Yervoy. We anticipate
selecting the RP2D before year end and look forward to providing an
update on gavo-cel in 1Q22 following review by the US Food and Drug
Administration.”
Recent Developments
Gavo-cel:
- TCR2 announced positive interim data from the first 17 patients
treated in the Phase 1 portion of the gavo-cel Phase 1/2 clinical
trial for mesothelin-expressing solid tumors. 15 of the 16 patients
evaluable for efficacy experienced regression of their target
lesions including 6 patients that achieved a partial response (PR)
by target lesion assessment, 4 of whom met criteria for a PR
according to RECIST 1.1 criteria. The maximum tolerated dose (MTD)
was declared 5x108/m2after lymphodepletion.
- Following identification of the MTD, TCR2 announced the
completion of the 3-patient cohort at the new dose level 3.5A
(3x108/m2 following lymphodepletion) using a split dosing approach.
Two patients were evaluable for safety. In both cases, gavo-cel was
well-tolerated with no patients experiencing Grade ≥3 cytokine
release syndrome (CRS).
- TCR2 announced a clinical trial collaboration agreement with
Bristol Myers Squibb (NYSE: BMY) to evaluate gavo-cel in
combination with Opdivo® (nivolumab) and Yervoy® (ipilimumab) in
its planned Phase 2 clinical trial in treatment refractory
mesothelin-expressing solid tumors.
Corporate:
- TCR2 announced at its virtual R&D Day on October 20, 2021,
its pipeline prioritization of solid tumors and highlighted
programs from its emerging TRuC pipeline including TC-510, its
first TRuC-T cell enhanced with a PD1xCD28 switch receptor; TC-520,
its lead candidate targeting CD70 expressing an IL-15 enhancement;
allogeneic TRuC-T cells; and TRuC Tregs, the first utilization of
the TRuC platform in the autoimmune setting.
- TCR2 announced the expansion of its manufacturing capacity by
exercising an option on a second clean room at ElevateBio BaseCamp
which adds to the buildout of clinical and commercial supply
currently underway at its Rockville, MD facility. In connection
with this expansion, TCR2 proposes to cease manufacturing
activities at the Cell and Gene Therapy Catapult (CGT Catapult) in
Stevenage, UK.
Anticipated Milestones
- TCR2 anticipates the identification of the recommended Phase 2
dose (RP2D) in 4Q21.
- TCR2 plans to file an IND for TC-510, the first enhanced TRuC-T
cell (targeting mesothelin with a PD1xCD28 switch), in the first
quarter of 2022.
- TCR2 anticipates initiation of IND-enabling studies for TC-520,
an enhanced CD70 targeting TRuC-T cell program in 2022.
- TCR2 plans to select a lead candidate for its allogeneic
program in 2022.
- TCR2 anticipates production of clinical trial material from
ElevateBio BaseCamp in anticipation of demand from the Phase 2
expansion trial of gavo-cel in 2022.
Financial Highlights
- Cash Position: TCR2 ended the third quarter of
2021 with $295.7 million in cash, cash equivalents, and investments
compared to $228.0 million as of December 31, 2020. Net cash used
in operations was $19.4 million for the third quarter of 2021
compared to $10.8 million for the third quarter of 2020. TCR2
projects net cash use of $100-105 million for 2021, the lower end
of the range previously provided. We expect cash on hand to support
operations through 2023.
- R&D Expenses: Research and development
expenses were $20.3 million for the third quarter of 2021 compared
to $12.8 million for the third quarter of 2020. The increase in
R&D expenses was primarily due to an increase in headcount,
additional lab facilities, and manufacturing facilities.
- G&A Expenses: General and administrative
expenses were $6.0 million for the third quarter of 2021 compared
to $4.4 million for the third quarter of 2020. The increase in
general and administrative expenses was primarily due to an
increase in personnel costs.
- Net Loss: Net loss was $26.2 million for the
third quarter of 2021 compared to $16.9 million for the third
quarter of 2020.
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 16, 2021 at
12:20pm GMT (7:20am ET)
- Piper Sandler 33rd Annual Virtual Healthcare Conference:
management will participate in a fireside chat using a virtual
platform on Monday, November 22, 2021 at 10:00am 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.
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 and the Company’s other product candidates,
timing of updates for the gavo-cel and TC-110 clinical trials,
expectations with respect to timing of our IND submission for
TC-510, expectations regarding preclinical data for our emerging
pipeline and enhancements, timing for the certification of
operation of our manufacturing facilities in Stevenage, UK and
Rockville, MD, increased manufacturing capacity and technical
capabilities, including through 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 Mauch 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, 2021 |
|
|
December 31, 2020 |
|
Assets |
|
|
|
|
|
Current
assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
262,497 |
|
|
$ |
94,155 |
|
Investments |
|
33,244 |
|
|
|
133,831 |
|
Prepaid expenses and other current assets |
|
7,478 |
|
|
|
7,552 |
|
Total current assets |
|
303,219 |
|
|
|
235,538 |
|
|
|
|
|
|
|
Property and equipment, net |
|
12,252 |
|
|
|
10,013 |
|
Right-of-use assets, operating leases |
|
29,432 |
|
|
|
- |
|
Restricted cash |
|
1,155 |
|
|
|
583 |
|
Other assets, non-current |
|
666 |
|
|
|
61 |
|
Total assets |
$ |
346,724 |
|
|
$ |
246,195 |
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
Accounts payable |
$ |
4,384 |
|
|
$ |
2,448 |
|
Accrued expenses and other current liabilities |
|
8,654 |
|
|
|
6,392 |
|
Operating lease liabilities |
|
3,482 |
|
|
|
- |
|
Total current liabilities |
|
16,520 |
|
|
|
8,840 |
|
|
|
|
|
|
|
Operating lease liabilities, non-current |
|
23,635 |
|
|
|
- |
|
Other liabilities |
|
299 |
|
|
|
807 |
|
Total liabilities |
|
40,454 |
|
|
|
9,647 |
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
Common stock, $0.0001 par value; 150,000,000 shares authorized;
38,220,444 and 33,516,795 shares issued and outstanding as of
September 30, 2021 and December 31, 2020, respectively. |
|
4 |
|
|
|
3 |
|
Additional paid-in capital |
|
628,064 |
|
|
|
486,197 |
|
Accumulated other comprehensive income (loss) |
|
(15) |
|
|
|
63 |
|
Accumulated deficit |
|
(321,783) |
|
|
|
(249,715) |
|
Total stockholders’ equity |
|
306,270 |
|
|
|
236,548 |
|
Total liabilities and stockholders’ equity |
$ |
346,724 |
|
|
$ |
246,195 |
|
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, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
20,277 |
|
|
$ |
12,820 |
|
|
$ |
54,828 |
|
|
$ |
37,682 |
|
General and administrative |
|
|
5,963 |
|
|
|
4,371 |
|
|
|
17,297 |
|
|
|
12,451 |
|
Total operating expenses |
|
|
26,240 |
|
|
|
17,191 |
|
|
|
72,125 |
|
|
|
50,133 |
|
Loss from operations |
|
|
(26,240) |
|
|
|
(17,191) |
|
|
|
(72,125) |
|
|
|
(50,133) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
38 |
|
|
|
300 |
|
|
|
186 |
|
|
|
1,546 |
|
Loss before
income tax expense |
|
|
(26,202) |
|
|
|
(16,891) |
|
|
|
(71,939) |
|
|
|
(48,587) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
|
42 |
|
|
|
31 |
|
|
|
129 |
|
|
|
86 |
|
Net
loss |
|
$ |
(26,244) |
|
|
$ |
(16,922) |
|
|
$ |
(72,068) |
|
|
$ |
(48,673) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Per share
information |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share of common stock, basic and diluted |
|
$ |
(0.69) |
|
|
$ |
(0.56) |
|
|
$ |
(1.91) |
|
|
$ |
(1.86) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares outstanding, basic and diluted |
|
|
38,197,929 |
|
|
|
30,340,355 |
|
|
|
37,816,345 |
|
|
|
26,158,040 |
|
TCR2
THERAPEUTICS INC. UNAUDITED CONSOLIDATED
STATEMENTS OF CASH FLOWS (amounts in thousands)
|
Nine Months Ended September 30, |
|
|
2021 |
|
|
2020 |
|
Operating activities |
|
|
|
|
|
Net loss |
$ |
(72,068) |
|
|
$ |
(48,673) |
|
Adjustments to reconcile net loss to cash used in operating
activities: |
|
|
|
|
|
Depreciation and amortization |
|
1,976 |
|
|
|
1,114 |
|
Stock-based compensation expense |
|
9,525 |
|
|
|
6,186 |
|
Amortization (accretion) on investments |
|
626 |
|
|
|
(574) |
|
Deferred tax liabilities |
|
105 |
|
|
|
86 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
Prepaid expenses and other current assets |
|
(41) |
|
|
|
(1,875) |
|
Operating leases, net |
|
(2,811) |
|
|
|
- |
|
Accounts payable |
|
2,066 |
|
|
|
610 |
|
Accrued expenses and other liabilities |
|
2,299 |
|
|
|
(114) |
|
Cash used in operating activities |
|
(58,323) |
|
|
|
(43,240) |
|
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
Purchases of equipment |
|
(4,352) |
|
|
|
(2,523) |
|
Software development costs |
|
(308) |
|
|
|
- |
|
Purchases of investments |
|
(40,732) |
|
|
|
(162,147) |
|
Proceeds from sale or maturity of investments |
|
140,622 |
|
|
|
109,916 |
|
Cash provided by (used in) investing activities |
|
95,230 |
|
|
|
(54,754) |
|
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
Proceeds from public offering of common stock, net of issuance
costs |
|
131,330 |
|
|
|
133,570 |
|
Proceeds from the exercise of stock options |
|
1,013 |
|
|
|
742 |
|
Payment of deferred offering costs |
|
(336) |
|
|
|
- |
|
Cash provided by financing activities |
|
132,007 |
|
|
|
134,312 |
|
|
|
|
|
|
|
Net
change in cash, cash equivalents, and restricted cash |
|
168,914 |
|
|
|
36,318 |
|
Cash, cash
equivalents, and restricted cash at beginning of year |
|
94,738 |
|
|
|
65,713 |
|
Cash, cash equivalents, and restricted cash at end of
period |
$ |
263,652 |
|
|
$ |
102,031 |
|
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