TCR² Therapeutics Reports Fourth Quarter and Full-Year 2022 Financial Results and Provides Corporate Update
- TCR² and
Adaptimmuneannounce strategic combination to create a preeminent cell therapy company focused on treating solid tumors
- Following the expected Q2 2023 closing of the all-stock transaction, the combined company's cash runway is expected to extend into 2026
“Focus and specialization are critical in the cell therapy space. The strategic combination with
- TCR² announced a strategic combination with
Adaptimmune Therapeutics plc( Adaptimmune) to create a preeminent cell therapy company for solid tumors. The two companies entered into a definitive agreement under which Adaptimmunewill combine with TCR² in an all-stock transaction. The transaction is expected to close in the second quarter of 2023, subject to shareholder approval and satisfaction or waiver of other closing conditions. Following the closing of the transaction, Adaptimmuneshareholders will own approximately 75% and TCR² stockholders will own approximately 25% of the combined company. As a result, and following the closing of the transaction, it is anticipated that the combined company’s cash runway will extend into 2026.
- TCR² published preclinical gavo-cel data in OncoImmunology. Research showed that gavo-cel more rapidly infiltrated and eliminated mesothelin-positive tumors of various histologies while producing less pro-inflammatory cytokines than second-generation mesothelin-targeted CAR T cells.
- TCR² reprioritized its pipeline to focus on gavo-cel in ovarian cancer and second-generation programs TC-510 and TC-520. In connection with the reprioritization, TCR² reduced its workforce by approximately 40 percent.
- First readout from the ongoing Phase 2 portion of the gavo‑cel Phase 1/2 clinical trial in ovarian cancer in combination with checkpoint inhibitors and redosing strategies anticipated in the second half of 2023.
- Interim update, including key translational data, in patients with mesothelioma treated with gavo‑cel in combination with checkpoint inhibitors in the Phase 2 portion of the gavo-cel Phase 1/2 clinical trial before the focus was narrowed to ovarian cancer anticipated midyear 2023.
- Tumor regression has been observed in 93% of patients in the Phase 1 trial. The response rate was 29% in patients with ovarian cancer with a median progression free survival (PFS) of 5.8 months and a median overall survival (OS) of 8.1 months. The response rate in mesothelioma was 21% with a median PFS of 5.9 months and a median OS of 11.2 months.
- First data readout from the Phase 1 trial with TC-510 for patients with ovarian, malignant pleural mesothelioma, pancreatic, colorectal, or triple-negative breast cancer anticipated in the second half of 2023.
- Cash Position: TCR² ended the fourth quarter of 2022 with
$149.2 millionin cash, cash equivalents, and investments compared to $265.6 millionas of December 31, 2021. Net cash used in operations was $25.0 millionfor the fourth quarter of 2022 compared to $23.3 millionfor the fourth quarter of 2021.
- R&D Expenses: Research and development (R&D) expenses were
$25.7 millionfor the fourth quarter of 2022 compared to $18.8 millionfor the fourth quarter of 2021. The increase in R&D expenses was primarily due to increased spending on clinical programs.
- Impairment and Restructuring Expenses: Impairment expenses were
$29.9 millionfor the fourth quarter of 2022 compared to $3.7 millionfor the fourth quarter of 2021. The impairment charges during 2022 are primarily related to the Rockville manufacturing facility which have been reclassified as held for sale as of December 31, 2022.
- G&A Expenses: General and administrative (G&A) expenses were
$5.8 millionfor the fourth quarter of 2022 compared to $5.2 millionfor the fourth quarter of 2021. The increase in G&A expenses was primarily due to an increase in personnel costs.
- Net Loss: Net loss was
$60.5 millionfor the fourth quarter of 2022 compared to $27.7 millionfor the fourth quarter of 2021.
About gavo-cel, TC-510, and TC-520
Our most advanced program, gavo-cel, targets tumors that express the protein mesothelin.
TC-510 is an enhanced version of gavo-cel that co-expresses a PD-1:CD28 chimeric switch receptor that the Company believes may lead to deeper responses and more durable benefit.
TC-520 is the Company’s first TRuC-T cell targeting CD-70-expressing solid and liquid tumors which incorporates IL-15 pathway enhancements designed to improve T-cell persistence. TCR² is currently advancing TC-520 to Investigational New Drug (IND) status.
About TCR² Therapeutics
TCR² Therapeutics Inc. is a clinical-stage cell therapy company developing a pipeline of novel next generation T cell therapies for 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.
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 TCR²’s other product candidates, including potential improvements in efficacy, safety and durability in the Phase 2 portion of the gavo-cel trial, expectations regarding future growth and prospects, future clinical development plans and anticipated timing of data updates, the development of the Company’s TRuC-T cells, including their potential characteristics, applications and clinical utility, the potential therapeutic applications of the TCR²’s TruC-T cell platform, expected cash runway of the combined company following the closing of the proposed transaction with
The expressed or implied forward-looking statements included in this press release are only current expectations, beliefs, and predictions and are subject to a number of risks, uncertainties, assumptions and important factors, including, without limitation: uncertainties as to the timing for completion of the transaction with
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. TCR² undertakes 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.
Chief Financial Officer
|TCR2 THERAPEUTICS INC.|
|UNAUDITED CONSOLIDATED BALANCE SHEETS|
|(amounts in thousands, except share data)|
|Cash and cash equivalents||$||32,746||$||222,564|
|Prepaid expenses and other current assets||5,155||10,534|
|Assets held for sale||23,287||-|
|Total current assets||177,621||276,127|
|Property and equipment, net||6,166||17,075|
|Right-of-use assets, operating leases||22,510||28,283|
|Other assets, non-current||787||730|
|Liabilities and stockholders’ equity|
|Accrued expenses and other current liabilities||10,823||13,094|
|Operating lease liabilities||21,834||3,367|
|Operating lease liabilities related to assets held for sale||28,611||-|
|Total current liabilities||64,061||18,605|
|Operating lease liabilities, non-current||3,316||22,996|
|Additional paid-in capital||642,644||631,008|
|Accumulated other comprehensive income (loss)||(445||)||(13||)|
|Total stockholders’ equity||140,859||281,477|
|Total liabilities and stockholders’ equity||$||208,236||$||323,371|
|TCR2 THERAPEUTICS INC.|
|UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(amounts in thousands, except share and per share data)|
|Three Months Ended
||Twelve Months Ended
|Research and development||$||25,736||$||18,750||$||98,643||$||73,578|
|Impairments and restructuring charges||29,883||3,661||30,417||3,661|
|General and administrative||5,803||5,206||24,439||22,503|
|Total operating expenses||61,422||27,617||153,499||99,742|
|Loss from operations||(61,422||)||(27,617||)||(153,499||)||(99,742||)|
|Interest income, net||1,013||38||1,938||224|
|Loss before income tax expense||(60,409||)||(27,579||)||(151,561||)||(99,518||)|
|Income tax expense||96||160||261||289|
|Per share information|
|Net loss per share of common stock, basic and diluted||$||(1.56||)||$||(0.72||)||$||(3.93||)||$||(2.63||)|
|Weighted average shares outstanding, basic and diluted||38,808,447||38,289,295||38,628,105||37,935,554|
|TCR2 THERAPEUTICS INC.|
|UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS|
|(amounts in thousands)|
|Twelve Months Ended
|Adjustments to reconcile net loss to cash used in operating activities:|
|Depreciation and amortization||3,046||2,827|
|Impairment and restructuring charges||27,450||2,960|
|Stock-based compensation expense||11,380||12,265|
|(Accretion) / Amortization on investments||(802||)||837|
|Deferred tax liabilities||(293||)||99|
|Changes in operating assets and liabilities:|
|Prepaid expenses and other current assets||5,557||(2,496||)|
|Operating leases, net||2,680||(2,416||)|
|Accrued expenses and other liabilities||177||4,899|
|Cash used in operating activities||(101,461||)||(81,603||)|
|Purchases of equipment||(15,122||)||(11,098||)|
|Software development costs||(330||)||(351||)|
|Purchases of investments||(267,522||)||(50,726||)|
|Proceeds from sale or maturity of investments||194,488||140,622|
|Cash provided by (used in) investing activities||(88,486||)||78,447|
|Proceeds from public offering of common stock, net of issuance costs||-||131,330|
|Proceeds from the exercise of stock options||256||1,217|
|Payment of deferred offering costs||(131||)||(409||)|
|Cash provided by financing activities||125||132,138|
|Net change in cash, cash equivalents, and restricted cash||(189,822||)||128,982|
|Cash, cash equivalents, and restricted cash at beginning of year||223,720||94,738|
|Cash, cash equivalents, and restricted cash at end of period||$||33,898||$||223,720|
Source: TCR2 Therapeutics