TCR2 Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Corporate Update
CAMBRIDGE, Mass., April 1, 2019 /PRNewswire/ -- TCR(2) Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage immunotherapy company developing the next generation of novel T cell therapies for patients suffering from cancer, today reported financial results for the fourth quarter and full year ended December 31, 2018 and provided a corporate update.
"TCR(2 )has achieved important scientific, clinical, and operational milestones over the past year," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR(2) Therapeutics. "Although adoptive T cell therapies have made significant progress in the fight against cancer, our TRuC platform has the potential to both improve upon existing options and expand their use. TC-210 has cleared its IND and we have initiated our Phase 1/2 clinical trial, with initial data expected later this year. We also remain on track to submit an IND for TC-110 in the second half of 2019. In February, we successfully completed our initial public offering, a significant step for the Company which further strengthened our financial position."
2018 Corporate Highlights
-- Advanced TC-210, TCR(2)'s lead T cell receptor (TCR) Fusion Construct T
cell (TRuC(TM) T cell) product candidate, to investigational new drug
(IND) application submission in December 2018 and IND clearance by the
U.S. Food and Drug Administration (FDA) in January 2019. TCR(2)
engineered TC-210 T cells to target and kill mesothelin-expressing
cancers while engaging the entire TCR, independent of human leukocyte
antigens (HLA). In preclinical studies, TC-210 has demonstrated better
anti-tumor activity, longer persistence, and lower cytokine release
compared to chimeric antigen receptor (CAR)-T cells engineered with the
same mesothelin binder. TCR(2) initiated a Phase 1/2 clinical trial for
TC-210 to treat patients with mesothelin-positive solid tumors,
including non-small cell lung cancer (NSCLC), ovarian cancer, malignant
pleural/peritoneal mesothelioma, and cholangiocarcinoma. TCR(2) expects
to generate its first clinical data for TC-210 in the second half of
2019.
-- Expanded the TCR(2) pipeline, initiating IND-enabling studies for TC-110
and TC-220 product candidates, and building next-generation enhancements
into the TRuC platform.
-- TC-110 is a CD19 targeted TRuC-T cell product candidate designed to
treat patients with CD19-positive B-cell hematological malignancies,
including diffuse large B-cell lymphoma (DLBCL), adult acute
lymphoblastic leukemia (aALL), follicular lymphoma (FL), and other
non-Hodgkin lymphoma (NHL) subtypes. In preclinical studies, TC-110
has shown better anti-tumor activity and persistence compared to
CD28 and 4-1BB CAR-T cells engineered with the same CD19 binder,
while also exhibiting lower levels of cytokine release.
-- TC-220 is a MUC16 (Mucin 16, Cell Surface Associated)-targeted
TRuC-T cell product candidate designed to treat patients with
MUC16-positive solid tumors. MUC16 is highly expressed in many solid
tumors, including ovarian, pancreatic, gastric, and colorectal
cancers. TC-220 has shown strong anti-tumor activity in preclinical
models of MUC16-positive ovarian cancers. TCR(2) plans to file an
IND for TC-220 in the first half of 2020.
-- TCR(2 )is developing several additional tools that may be
incorporated into future TRuC product candidates to overcome tumor
defense mechanisms, including dual-antigen targeting and strategies
to counter the immunosuppressive microenvironment of solid tumors.
TCR(2) is also evaluating multiple proprietary designs for
allogeneic, or off the shelf, TRuC-T cells.
-- Established semi-automated Good Manufacturing Practice (GMP)
manufacturing process. TCR(2) currently manufactures GMP-grade clinical
lots for TC-210 through third-party contractors. In December 2018,
TCR(2) entered into an agreement with Cell and Gene Therapy (CGT)
Catapult Limited (Catapult), which will allow TCR(2) to manufacture
TRuC-T cells using its own personnel at CGT Catapult's facility in
Stevenage, UK. The TCR(2) CGT Catapult facility is expected to be
operational in the second half of 2019. At full capacity, TCR(2)
estimates this facility would expand its manufacturing capacity to a
total of approximately 400 treatments per year.
-- Raised $125 million in an oversubscribed Series B financing round in
March 2018. The financing was co-led by 6 Dimensions Capital and
Curative Ventures with participation from new investors Redmile and
Arrowmark and all of TCR(2)'s Series A investors.
-- Strengthened its management and board in 2018. This included adding Ian
Somaiya as Chief Financial Officer, along with Neil Gibson Ph.D. and
Andrew Allen M.D., Ph.D. to the Board of Directors.
Recent Developments
-- In January 2019, the FDA cleared the IND for TC-210. TCR(2) initiated
its Phase 1/2 trial to treat patients with NSCLC, ovarian cancer,
malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma.
TCR(2) expects to generate initial data from the trial in the second
half of 2019.
-- In February 2019, TCR(2) completed an initial public offering pursuant
to which it issued and sold 5,750,000 shares of common stock, including
full exercise of the underwriters' over-allotment option, resulting in
net proceeds of $80.2 million after deducting underwriting discounts and
commissions and other offering expenses.
-- In February 2019, the FDA granted orphan drug designation to TC-210 for
the treatment of mesothelioma.
-- TCR(2) recently held a pre-IND meeting with the FDA and remains on track
to submit an IND for TC-110 in the second half of 2019.
-- In February 2019, the United States Patent and Trademark Office issued
U.S. Patent No.: 10,208,285, with claims covering TCR(2)'s TRuC-T cells
that express anti-mesothelin TCR fusion proteins, including TC-210.
Anticipated Milestones
TCR(2 )plans to advance its first three TRuC-T cell product candidates into clinical trials by the first half of 2020, while also establishing and expanding its manufacturing capabilities through its collaboration with CGT Catapult.
-- TC-210 - release initial Phase 1 data from the Phase 1/2 trial in 2H
2019.
-- TC-110 - IND submission in 2H 2019.
-- TC-220 - IND submission in 1H 2020.
-- Catapult manufacturing facility - operational in 2H 2019.
Financial Highlights
-- TCR(2) ended 2018 with $123.2 million in cash, cash equivalents, and
investments compared to $19.8 million as of December 31, 2017. Net cash
from financing activities for the year ended December 31, 2018 was
$123.0 million compared to $16.2 for the year ended December 31, 2017.
Net cash used in operations was $18.8 million for the year ended
December 31, 2018 compared to $12.0 million for the year ended December
31, 2017.
-- Net loss for the year ended December 31, 2018 was $24.3 million compared
to $13.1 million for the year ended December 31, 2017.
-- Research and development expenses were $19.7 million for the year ended
December 31, 2018 compared to $9.6 million for the year ended December
31, 2017. The increase in R&D expenses is primarily related to increase
in headcount and preclinical development of our lead solid tumor product
candidate, TC-210.
-- General and administrative expenses were $6.8 million for the year ended
December 31, 2018, compared to $3.6 million for the year ended December
31, 2017. The increase in general and administrative expenses was
primarily due to an increase in personnel costs.
Upcoming Events
Members of the TCR(2 )Therapeutics management team are scheduled to present at the following upcoming conferences.
-- Jefferies Immuno-Oncology Cell Therapy Summit: Alfonso Quintás Cardama,
M.D., Chief Medical Officer, will present on Friday, April 5, 2019 at
7:30 am ET in Boston, MA.
-- 4th Annual CAR-T Congress USA: Robert Hofmeister Ph.D., Chief Scientific
Officer, will present on Wednesday, April 17, 2019 at 9:40 am ET in
Boston, MA.
-- Class of 2018 Biotech IPOs Investor Day: Ian Somaiya, Chief Financial
Officer, will present on Friday, April 26, 2019 at the offices of Davis
Polk in New York, NY.
-- BioTrinity 2019: Garry Menzel, Ph.D., President and CEO, will present on
Tuesday, April 30, 2019 in London, UK.
About TCR(2) Therapeutics
TCR(2) Therapeutics Inc. is a clinical-stage immunotherapy company developing the next generation of novel T cell therapies for patients suffering from cancer. TCR(2)'s( )proprietary T cell receptor (TCR) Fusion Construct T cells (TRuC-T(TM) 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 exhibiting lower levels of cytokine release. The Company's lead TRuC-T cell product candidate, TC-210, 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 cholangiocarincoma. For more information about TCR(2), 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 TCR(2)'s plans to submit an IND for TC-110 in the second half of 2019; the generation of clinical data for TC-210 in the second half of 2019; expectations that TCR(2)'s Catapult facility will be operational in the second half of 2019 and related effects on TCR(2)'s manufacturing capacity in the future; and TCR(2)'s plans to advance its first three TRuC product candidates into clinical trials by the first half of 2020.
The express 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; TCR(2)'s ability to maintain sufficient manufacturing capabilities to support its research, development and commercialization efforts, whether TCR(2)'s cash resources will be sufficient to fund TCR(2)'s foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other risks set forth under the caption "Risk Factors" in TCR(2)'s most recent Annual Report on Form 10-K 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 TCR(2) 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 TCR(2) 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.
TCR(2) THERAPEUTICS INC.
CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except share data)
(unaudited)
December 31,
2018 2017
---
Assets
Current assets
Cash $
47,674 $
19,811
Investments 75,493
Prepaid expenses and
other current assets 2,326 892
---
Total current assets 125,493 20,703
Property and
equipment, net 1,638 1,026
Restricted cash 290 290
Deferred offering
costs 2,012 20
---
Total assets $
129,433 $
22,039
===
Liabilities, redeemable convertible
preferred stock and stockholders'
equity (deficit)
Accounts payable $
2,663 $
427
Accrued expenses and
other current
liabilities 2,802 804
---
Total current
liabilities 5,465 1,231
Other liabilities 434 30
---
Total liabilities 5,899 1,261
Redeemable convertible preferred stock,
$0.0001 par value
Series A preferred
stock 44,500,001
shares authorized;
45,000,000 shares
issued and
outstanding at
December 31, 2018 and
2017 (liquidation
preference of $49.8
million at December
31, 2018) 72,980 47,102
Series B preferred
stock: 62,500,000 and (liquidation value of
no shares authorized $130.9 million at
at December 31, 2018 December 31, 2018).
and 2017,
respectively;
62,500,000 shares and
no shares authorized
and outstanding as of
December 31, 2018 and
2017, respectively 136,250
---
Total redeemable
convertible preferred
stock 209,230 47,102
Common stock, $0.0001
par value; 20,988,730 shares outstanding at
and 13,239,045 shares December 31, 2018 and
authorized at 2017, respectively.
December 31, 2018 and
2017, respectively;
914,602 and 612,962
shares issued at
December 31, 2018 and
2017, respectively;
726,994 and 435,630 -
Additional paid-in
capital -
Accumulated other
comprehensive income
(loss) (106)
Accumulated deficit (85,590) (26,324)
---
Total stockholders'
equity (deficit) (85,696) (26,324)
---
Total liabilities,
redeemable preferred
stock and
stockholders' equity
(deficit) $
129,433 $
22,039
===
TCR(2) THERAPEUTICS INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands, except share and per share data)
(unaudited)
Three Months Ended
Years Ended
December 31, December 31,
2018 2017 2018 2017
---
Operating expenses
Research and
development $
6,219 $
2,747 $
19,673 $
9,569
General and
administrative 2,222 1,290 6,780 3,611
---
Total operating
expenses 8,441 4,037 26,453 13,180
---
Loss from
operations (8,441) (4,037) (26,453) (13,180)
Other income, net 751 25 2,202 110
---
Net loss (7,690) (4,012) (24,251) (13,070)
Accretion of
redeemable
convertible
preferred stock to
redemption value (3,730) (522) (37,298) (1,794)
---
Net loss
attributable to
common
stockholders $
(11,420) $
(4,534) $
(61,549) $
(14,864)
===
Per share information
Net loss per share
of common stock,
basic and diluted $
(16.22) $
(11.02) $
(98.53) $
(39.94)
===
Weighted average
shares
outstanding, basic
and diluted 703,874 411,289 624,659 372,116
TCR(2) THERAPEUTICS INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(amounts in thousands)
(unaudited)
YEARS ENDED DECEMBER 31,
2018 2017
---
Operating activities:
Net loss $
(24,251) $
(13,070)
Adjustments to reconcile net loss to
cash used in operating activities:
Depreciation and
amortization 419 298
Stock-based
compensation expense 2,133 408
Loss on fixed asset
disposal 2
Accretion on
investments (280)
Changes in operating assets and
liabilities:
Interest receivable on
investments (390)
Prepaid expenses and
other current assets (1,043) 103
Accounts payable 2,224 (101)
Accrued expenses and
other liabilities 2,408 347
---
Cash used in operating
activities (18,778) (12,015)
---
Investing activities:
Purchase of investments (97,810) (6,480)
Proceeds from maturity
of investments 22,490 14,830
Change in restricted
cash - (290)
Purchases of equipment (1,019) (388)
---
Cash (used in) provided
by investing
activities (76,339) 7,672
---
Financing activities:
Proceeds from the sale
of Series A preferred
stock - 16,167
Proceeds from the sale
of Series B preferred
stock 125,000
Proceeds from the
exercise of stock
options 140 44
Deferred offering costs (1,990) (20)
Payment of issuance
costs (170) (28)
---
Cash provided by
financing activities 122,980 16,163
---
Net increase in cash
and cash equivalents 27,863 11,820
Cash and cash
equivalents at
beginning of year 19,811 7,991
---
Cash and cash
equivalents at end of
year $
47,674 $
19,811
===
Supplemental disclosure of noncash
financing activities:
Accretion of redeemable
convertible preferred
stock to redemption
value $
37,298 $
1,794
Deferred offering costs
included in accounts
payable 558 20
Property and equipment
additions in accounts
payable 14
Reclassification of
early exercise
liability upon vesting
of options 10
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