Le Lézard
Classified in: Health, Business
Subjects: ERN, OFR, FDA

TCR2 Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Corporate Update


CAMBRIDGE, Mass., April 1, 2019 /PRNewswire/ -- TCR2 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.

"TCR2 has achieved important scientific, clinical, and operational milestones over the past year," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 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

Recent Developments

Anticipated Milestones

TCR2 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.

Financial Highlights

Upcoming Events

Members of the TCR2 Therapeutics management team are scheduled to present at the following upcoming conferences.

About TCR2 Therapeutics
TCR2 Therapeutics Inc. is a clinical-stage immunotherapy company developing the next generation of novel T cell therapies for patients suffering from cancer. TCR2's proprietary T cell receptor (TCR) Fusion Construct T cells (TRuC-Ttm 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 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 TCR2'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 TCR2's Catapult facility will be operational in the second half of 2019 and related effects on TCR2's manufacturing capacity in the future; and TCR2'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; TCR2's ability to maintain sufficient manufacturing capabilities to support its research, development and commercialization efforts, whether TCR2's cash resources will be sufficient to fund TCR2's foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other risks set forth under the caption "Risk Factors" in TCR2'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 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.

TCR2 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 no shares authorized at December 31, 2018 and 2017, respectively; 62,500,000 shares and no shares authorized and outstanding as of December 31, 2018 and 2017, respectively (liquidation value of $130.9 million at December 31, 2018).

136,250



?

Total redeemable convertible preferred stock

209,230



47,102





Common stock, $0.0001 par value; 20,988,730 and 13,239,045 shares authorized at 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 shares outstanding at December 31, 2018 and 2017, respectively.

?



?

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

 

TCR2 THERAPEUTICS INC.


CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands, except share and per share data)
(unaudited)



Three Months Ended
December 31,


Years Ended
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

 

TCR2 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



?

 

SOURCE TCR2 Therapeutics


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