8-K
false000175001900017500192022-05-122022-05-12

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported):

May 12, 2022

 

TCR2 THERAPEUTICS INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

001-38811

 

47-4152751

(State or other jurisdiction of incorporation)

 

(Commission File Number)

 

(I.R.S Employer Identification No.)

 

100 Binney Street

Suite 710

Cambridge

MA

02142

 

(Address of Principal Executive Offices)

 

(Zip Code)

 

(617) 949-5200

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock

TCRR

The Nasdaq Stock Market, LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 


 

 

Item 2.02 Results of Operations and Financial Condition

 

On May 12, 2022, TCR2 Therapeutics Inc. announced its financial results for the fiscal quarter ended March 31, 2022. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in this Report on Form 8-K, including Exhibit 99.1, attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit No.

 

Description

99.1

 

Press release dated May 12, 2022

104

 

Inline XBRL cover page

 

Signatures

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date:

May 12, 2022

 

TCR2 Therapeutics Inc.

 

 

 

 

 

 

 

 

By:

/s/ Garry E. Menzel

 

 

 

 

Garry E. Menzel

 

 

 

 

President and Chief Executive Officer

 

 


EX-99.1

 

Exhibit 99.1

 

https://cdn.kscope.io/736b04c3f477a2bb77d9598819686d47-img238177558_0.jpg 

 

TCR2 Therapeutics Reports First Quarter 2022 Financial Results and Provides Corporate Update

- Initiated Phase 2 expansion portion of the ongoing gavo-cel clinical trial

- IND Clearance for Phase 1/2 clinical trial of TC-510

- 30 patients treated with gavo-cel in the expanded Phase 1 trial; dataset review in July 2022

- Updates anticipated in the second half of 2022

 

CAMBRIDGE, Mass., May 12, 2022 - 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 first quarter ended March 31, 2022 and provided a corporate update.

 

“We are very pleased with the momentum generated in the last quarter as we initiated the next phases on two clinical programs and expect to present in July an expanded dataset on 30 patients treated with gavo-cel,” said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. “The consistent tumor regression observed with gavo-cel in Phase 1 establishes a baseline efficacy and safety profile upon which we can build in Phase 2. With the initiation of the TC-510 Phase 1 clinical trial, which includes the treatment of pancreatic cancer, colorectal cancer and triple negative breast cancer, we have an opportunity to expand the number of indications potentially addressable with our TRuC-T cell therapies. We look forward to a busy second half of execution as we scale these clinical trials as well as build out our preclinical pipeline targeting CD70 with enhancements and allogeneic strategies.”

 

Recent Developments

 

Gavo-cel:

TCR2 initiated the Phase 2 expansion portion of the ongoing Phase 1/2 clinical trial of gavo-cel, its first-in-class TRuC-T cell targeting mesothelin-expressing solid tumors. Enrollment is ongoing and the Company expects to report on progress from the Phase 2 portion of the clinical trial in the second half of 2022.
TCR2 announced the Company plans to present the expanded Phase 1 dataset for gavo-cel from the dose escalation portion of the Phase 1/2 clinical trial of gavo-cel in patients with treatment refractory mesothelin-expressing solid tumors in July 2022. The presentation will focus on safety, efficacy and translational data and include 30 patients from the Phase 1 dose escalation, with data from additional malignant pleural/peritoneal mesothelioma (MPM) and ovarian patients.

 

TC-510:

TCR2 announced the U.S. Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for TC-510, a TRuC-T cell targeting mesothelin that co-expresses a PD-1:CD28 chimeric switch receptor. The Phase 1/2 clinical trial is evaluating the safety and efficacy of TC-510 in patients with mesothelin-expressing MPM, ovarian cancer, pancreatic cancer, colorectal cancer and triple negative breast cancer. The Company expects to report on progress from the Phase 1 portion of the clinical trial in the second half of 2022.

 

 


 

Anticipated Milestones

 

Gavo-cel:

Present the expanded Phase 1 dataset for gavo-cel in July 2022.
Provide an update from the Phase 2 portion 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 first quarter of 2022 with $232.2 million in cash, cash equivalents, and investments compared to $265.6 million as of December 31, 2021. Net cash used in operations was $31.1 million for the first quarter of 2022 compared to $23.9 million for the first quarter of 2021. TCR2 projects net cash use of $115-125 million for 2022, the lower end of the range previously provided. We expect cash on hand to support operations into 2024.

 

R&D Expenses: Research and development expenses were $22.9 million for the first quarter of 2022 compared to $15.9 million for the first quarter of 2021. The increase in R&D expenses was primarily due to an increase in headcount, clinical trial expenses associated with patient treatment and manufacturing, and manufacturing facilities expenses.

 

G&A Expenses: General and administrative expenses were $6.3 million for the first quarter of 2022 compared to $5.7 million for the first quarter of 2021. The increase in general and administrative expenses was due to an increase in personnel costs and other professional fees.

 

Net Loss: Net loss was $29.1 million for the first quarter of 2022 compared to $21.5 million for the first quarter of 2021.

 

Upcoming Events

 

TCR2 Therapeutics management is scheduled to participate at the following upcoming conferences.

H.C. Wainwright Global Investment Conference: Garry Menzel, President and Chief Executive Officer of TCR2 Therapeutics, will present an update on Company progress on Tuesday, May 24, 2022 at 7:00am 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.

 

About gavo-cel

 

The ongoing gavo-cel Phase 1/2 clinical trial is evaluating the safety and efficacy of gavo-cel in patients with mesothelin-expressing MPM, ovarian cancer, non-small cell lung cancer (NSCLC) and cholangiocarcinoma.

 

In the Phase 2 portion of the clinical trial, patients will receive gavo-cel at the recommended Phase 2 dose (RP2D)(1x108 cells/m2). A total of 75 patients will be treated in the MPM cohort and a total of 20 patients will be treated in each one of the following indications: ovarian, NSCLC and cholangiocarcinoma. In the MPM cohort, patients will be randomized to receive either single agent gavo-cel, gavo-cel in combination with Opdivo (nivolumab), or gavo-cel in combination with Opdivo and Yervoy (ipilimumab). In ovarian, NSCLC and cholangiocarcinoma, all patients will receive gavo-cel in combination with Opdivo.

 

About TC-510

 

TC-510 is a mesothelin-targeted TRuC-T cell that co-expresses a PD-1:CD28 chimeric switch receptor to provide a local costimulatory signal by engaging with PD-L1 expressed in the hostile tumor microenvironment and converting the negative inhibitory signal into a positive costimulatory signal.

 

The TC-510 Phase 1/2 clinical trial is evaluating the safety and efficacy of TC-510 in patients with mesothelin-expressing MPM, ovarian cancer, pancreatic cancer, colorectal cancer and triple negative breast cancer.

 

The Phase 1 portion of the clinical trial utilizes a modified 3+3 design with five escalating dose levels for TC-510 (50x106, 100x106, 130x106, 160x106, and 200x106 cells). At each dose level, TC-510 will be treated with lymphodepletion chemotherapy and after the first patient is treated at each dose level, a 28-day safety observation period is instituted. Then, patients 2 and 3 may be infused simultaneously. The primary objective for the study is patient safety with a key secondary objective to determine the RP2D. In addition to standard measures of safety and efficacy, translational work includes the assessment of expansion, trafficking, and persistence of TC-510 T cells.

 

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 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, future IND-enabling studies and filings, future

 


 

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)

 

 

March 31,
2022

 

 

December 31,
2021

 

Assets

 

 

 

 

 

Current assets

 

 

 

 

 

Cash and cash equivalents

$

74,117

 

 

$

222,564

 

Investments

 

158,071

 

 

 

43,029

 

Prepaid expenses and other current assets

 

15,115

 

 

 

10,534

 

Total current assets

 

247,303

 

 

 

276,127

 

 

 

 

 

 

 

Property and equipment, net

 

18,767

 

 

 

17,075

 

Right-of-use assets, operating leases

 

55,228

 

 

 

28,283

 

Restricted cash

 

1,158

 

 

 

1,156

 

Other assets, non-current

 

791

 

 

 

730

 

Total assets

$

323,247

 

 

$

323,371

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

Accounts payable

$

4,482

 

 

$

2,144

 

Accrued expenses and other current liabilities

 

9,452

 

 

 

13,094

 

Operating lease liabilities

 

16,933

 

 

 

3,367

 

Total current liabilities

 

30,867

 

 

 

18,605

 

 

 

 

 

 

 

Operating lease liabilities, non-current

 

36,751

 

 

 

22,996

 

Other liabilities

 

313

 

 

 

293

 

Total liabilities

 

67,931

 

 

 

41,894

 

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

Common stock, $0.0001 par value; 150,000,000 shares authorized; 38,546,345 and 38,496,484 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively.

 

4

 

 

 

4

 

Additional paid-in capital

 

634,300

 

 

 

631,008

 

Accumulated other comprehensive income (loss)

 

(344

)

 

 

(13

)

Accumulated deficit

 

(378,644

)

 

 

(349,522

)

Total stockholders’ equity

 

255,316

 

 

 

281,477

 

Total liabilities and stockholders’ equity

$

323,247

 

 

$

323,371

 

 

 

 

 


 

TCR2 THERAPEUTICS INC.

UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS

(amounts in thousands, except share and per share data)

 

 

 

Three Months Ended
March 31,

 

 

 

2022

 

 

2021

 

Operating expenses

 

 

 

 

 

 

Research and development

 

$

22,883

 

 

$

15,924

 

General and administrative

 

 

6,320

 

 

 

5,668

 

Total operating expenses

 

 

29,203

 

 

 

21,592

 

Loss from operations

 

 

(29,203

)

 

 

(21,592

)

 

 

 

 

 

 

 

Interest income, net

 

 

117

 

 

 

116

 

Loss before income tax expense

 

 

(29,086

)

 

 

(21,476

)

 

 

 

 

 

 

 

Income tax expense

 

 

36

 

 

 

36

 

Net loss

 

$

(29,122

)

 

$

(21,512

)

 

 

 

 

 

 

 

Per share information

 

 

 

 

 

 

Net loss per share of common stock, basic and diluted

 

$

(0.76

)

 

$

(0.58

)

 

 

 

 

 

 

 

Weighted average shares outstanding, basic and diluted

 

 

38,513,104

 

 

 

37,062,604

 

 

 

 

 


 

 

TCR2 THERAPEUTICS INC.

UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS

(amounts in thousands)

 

 

Three Months Ended March 31,

 

 

2022

 

 

2021

 

Operating activities

 

 

 

 

 

Net loss

$

(29,122

)

 

$

(21,512

)

Adjustments to reconcile net loss to cash used in operating activities:

 

 

 

 

 

Depreciation and amortization

 

706

 

 

 

513

 

Stock-based compensation expense

 

3,177

 

 

 

3,120

 

Amortization on investments

 

20

 

 

 

164

 

Deferred tax liabilities

 

21

 

 

 

36

 

Changes in operating assets and liabilities:

 

 

 

 

 

Prepaid expenses and other current assets

 

(4,400

)

 

 

(2,265

)

Operating leases, net

 

375

 

 

 

(3,808

)

Accounts payable

 

1,756

 

 

 

1,684

 

Accrued expenses and other liabilities

 

(3,667

)

 

 

(1,859

)

Cash used in operating activities

 

(31,134

)

 

 

(23,927

)

 

 

 

 

 

 

Investing activities

 

 

 

 

 

Purchases of equipment

 

(1,911

)

 

 

(1,491

)

Software development costs

 

(66

)

 

 

-

 

Purchases of investments

 

(148,382

)

 

 

(40,732

)

Proceeds from sale or maturity of investments

 

32,989

 

 

 

59,287

 

Cash provided by (used in) investing activities

 

(117,370

)

 

 

17,064

 

 

 

 

 

 

 

Financing activities

 

 

 

 

 

Proceeds from public offering of common stock, net of issuance costs

 

-

 

 

 

131,330

 

Proceeds from the exercise of stock options

 

115

 

 

 

376

 

Payment of deferred offering costs

 

(56

)

 

 

(164

)

Cash provided by financing activities

 

59

 

 

 

131,542

 

 

 

 

 

 

 

Net change in cash, cash equivalents, and restricted cash

 

(148,445

)

 

 

124,679

 

Cash, cash equivalents, and restricted cash at beginning of year

 

223,720

 

 

 

94,738

 

Cash, cash equivalents, and restricted cash at end of period

$

75,275

 

 

$

219,417

 

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