Delaware | 001-38811 | 47-4152751 | ||
(State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S Employer Identification No.) |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Common Stock | TCRR | The Nasdaq Stock Market, LLC |
Exhibit No. | Description | |
99.1 |
Date: | August 8, 2019 | TCR2 Therapeutics Inc. | ||
By: | /s/ Mayur (Ian) Somaiya | |||
Mayur (Ian) Somaiya | ||||
Chief Financial Officer |
• | Began dosing of TC-210 in the Phase 1/2 trial for patients with mesothelin-expressing solid tumors and an interim update anticipated in 4Q19/1Q20 |
• | Leading clinical sites participating in the TC-210 trial include Sarah Cannon Research Institute, MD Anderson Cancer Center and the National Cancer Institute |
• | IND filing for TC-110 in patients with CD19+ non-Hodgkin lymphoma or adult acute lymphoblastic leukemia anticipated in 2H19 |
• | TCR2 has begun dosing in its Phase 1/2 clinical trial of TC-210 to treat patients with mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma or cholangiocarcinoma. |
• | TCR2 announced that it entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to collaborate on the use of TCR2’s proprietary TRuC-T cells as a cancer therapeutic agent against mesothelin in the Company’s ongoing Phase 1/2 trial of TC-210. |
• | TCR2 expanded its manufacturing and immuno-oncology expertise by hiring Vice Presidents Nigel Williams, Robert Tighe and Dario Gutierrez, Ph.D. The expansion of the leadership team strengthens the Company’s core competencies of manufacturing, IND enablement and innovation as it advances a broad portfolio of next generation TRuC-T cells. |
• | The United States Patent and Trademark Office issued patents with claims covering TCR2’s T cell receptor (TCR) Fusion Construct T cells (TRuCTM-T cells) that express anti-B-cell maturation antigen (BCMA) and anti-CD19 TCR fusion proteins, including TC-110. |
• | The Phase 1/2 clinical trial (NCT03907852) is evaluating the safety and efficacy of TC-210, TCR2’s T-cell receptor fusion construct against mesothelin at Sarah Cannon Research Institute, MD Anderson Cancer Center and the NCI. The trial is enrolling patients with mesothelin expressing non-small cell lung cancer (NSCLC), ovarian cancer, cholangiocarcinoma or malignant pleural/peritoneal mesothelioma. |
• | The Phase 1 portion of the clinical trial utilizes a 3+3 design with four escalating dose levels for TC-210. At each dose level, TC-210 is first administered without lymphodepletion and then following lymphodepleting chemotherapy. The primary objective for the study is patient safety with a key secondary objective to determine the recommended Phase 2 dose (RP2D). In addition to standard measures of safety and efficacy, translational work includes the assessment of TC-210 T cells for expansion, trafficking, persistence and phenotypic changes. |
• | Under the terms of the CRADA, NCI will conduct translational studies, measuring potential biomarkers in patients treated with TCR2 Therapeutics’ proprietary mesothelin-specific T cell-based therapy to better understand the pharmacodynamics of TC-210. |
• | In the Phase 2 portion of the clinical trial, approximately 50 patients are initially planned to receive TC-210 at the RP2D in four distinct cohorts according to their cancer diagnosis: NSCLC, ovarian cancer, malignant pleural/peritoneal mesothelioma and cholangiocarcinoma. Each cohort includes ten patients, except the NSCLC cohort which includes 20 patients with eight patients to receive TC-210 as single agent and 12 to receive TC-210 in combination with a programmed cell death 1 (PD-1) blocking antibody. |
• | Cash Position: TCR2 ended the second quarter of 2019 with $180.7 million in cash, cash equivalents, and investments compared to $123.2 million as of December 31, 2018. Net cash used in operations was $21.0 million in the first half of 2019 compared to $7.7 million in the first half of 2018. |
• | R&D Expenses: Research and development expenses were $8.8 million for the second quarter of 2019 compared to $5.2 million for the second quarter of 2018. The increase in R&D expenses is primarily related to increase in headcount and activities related to the start of the Phase 1/2 clinical trial of the Company’s lead solid tumor product candidate, TC-210. |
• | G&A Expenses: General and administrative expenses were $3.3 million for the second quarter of 2019 compared to $1.6 million for the second quarter of 2018. The increase in general and administrative expenses was primarily due to an increase in personnel costs and cost associated with operations as a public company. |
• | Net loss: Net loss was $11.1 million for the second quarter of 2019 compared to $6.2 million for the second quarter of 2018, driven predominantly by increased R&D expense in the quarter. |
• | BTIG Biotechnology Conference 2019: Ian Somaiya, Chief Financial Officer of TCR2 Therapeutics, will be available for one-on-one meetings on Monday, August 12, 2019 in New York, NY. |
• | 2019 Wedbush PacGrow Healthcare Conference: Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics, will present on Tuesday, August 13, 2019 at 8:00am ET in New York, NY. |
June 30, 2019 | December 31, 2018 | ||||||
Assets | |||||||
Current assets | |||||||
Cash and cash equivalents | $ | 40,980 | $ | 47,674 | |||
Investments | 128,646 | 75,493 | |||||
Prepaid expenses and other current assets | 6,051 | 2,326 | |||||
Total current assets | 175,677 | 125,493 | |||||
Property and equipment, net | 3,172 | 1,638 | |||||
Investments, non-current | 11,121 | — | |||||
Restricted cash | 290 | 290 | |||||
Deferred offering costs | — | 2,012 | |||||
Total assets | $ | 190,260 | $ | 129,433 | |||
Liabilities, redeemable convertible preferred stock, and stockholders’ equity (deficit) | |||||||
Accounts payable | $ | 4,044 | $ | 2,663 | |||
Accrued expenses and other current liabilities | 3,116 | 2,802 | |||||
Total current liabilities | 7,160 | 5,465 | |||||
Other liabilities | 464 | 434 | |||||
Total liabilities | 7,624 | 5,899 | |||||
Redeemable convertible preferred stock | |||||||
Series A preferred stock, $0.0001 par value; no shares and 45,000,000 authorized, issued, or outstanding at June 30, 2019 and December 31, 2018. | — | 72,980 | |||||
Series B preferred stock, $0.0001 par value; no shares and 62,500,000 authorized, issued, or outstanding at June 30, 2019 and December 31, 2018. | — | 136,250 | |||||
Total redeemable convertible preferred stock | — | 209,230 | |||||
Stockholders' equity (deficit) | |||||||
Preferred stock, $0.0001 par value. 10,000,000 and no shares authorized, issued or outstanding at June 30, 2019 and December 31, 2018, respectively. | — | — | |||||
Common stock, $0.0001 par value; 150,000,000 and 20,988,730 shares authorized at June 30, 2019 and December 31, 2018, respectively; 23,964,746 and 914,602 shares issued at June 30, 2019 and December 31, 2018, respectively; 23,856,689 and 726,994 shares outstanding at June 30, 2019 and December 31, 2018, respectively. | 2 | — | |||||
Additional paid-in capital | 338,380 | — | |||||
Accumulated other comprehensive income (loss) | 212 | (106 | ) | ||||
Accumulated deficit | (155,958 | ) | (85,590 | ) | |||
Total stockholders’ equity (deficit) | 182,636 | (85,696 | ) | ||||
Total liabilities, redeemable preferred stock and stockholders’ equity (deficit) | $ | 190,260 | $ | 129,433 |
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Operating expenses | ||||||||||||||||
Research and development | $ | 8,833 | $ | 5,175 | $ | 16,722 | $ | 8,068 | ||||||||
General and administrative | 3,307 | 1,634 | 6,193 | 2,854 | ||||||||||||
Total operating expenses | 12,140 | 6,809 | 22,915 | 10,922 | ||||||||||||
Loss from operations | (12,140 | ) | (6,809 | ) | (22,915 | ) | (10,922 | ) | ||||||||
Interest income, net | 1,077 | 622 | 1,949 | 749 | ||||||||||||
Net loss | (11,063 | ) | (6,187 | ) | (20,966 | ) | (10,173 | ) | ||||||||
Accretion of redeemable convertible preferred stock to redemption value | — | (11,145 | ) | (49,900 | ) | (21,978 | ) | |||||||||
Net loss attributable to common stockholders | $ | (11,063 | ) | $ | (17,332 | ) | $ | (70,866 | ) | $ | (32,151 | ) | ||||
Per share information | ||||||||||||||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.46 | ) | $ | (27.97 | ) | $ | (3.91 | ) | $ | (56.75 | ) | ||||
Weighted-average shares outstanding, basic and diluted | 23,818,003 | 619,749 | 18,105,142 | 566,513 |
Six Months Ended June 30, | |||||||
2019 | 2018 | ||||||
Operating activities: | |||||||
Net loss | $ | (20,966 | ) | (10,173 | ) | ||
Adjustments to reconcile net loss to cash used in operating activities: | |||||||
Depreciation and amortization | 300 | 188 | |||||
Stock-based compensation expense | 2,585 | 633 | |||||
Loss on fixed asset disposal | — | 2 | |||||
Accretion on investments | (252 | ) | (76 | ) | |||
Changes in operating assets and liabilities: | |||||||
Interest receivable on investments | (325 | ) | (78 | ) | |||
Prepaid expenses and other current assets | (3,158 | ) | 153 | ||||
Accounts payable | 180 | 1,165 | |||||
Accrued expenses and other liabilities | 646 | 493 | |||||
Cash used in operating activities | (20,990 | ) | (7,693 | ) | |||
Investing activities: | |||||||
Purchase of investments | (106,566 | ) | (32,343 | ) | |||
Proceeds from maturity of investments | 42,619 | 5,530 | |||||
Purchases of equipment | (941 | ) | (772 | ) | |||
Cash used in investing activities | (64,888 | ) | (27,585 | ) | |||
Financing activities: | |||||||
Proceeds from the sale of Series B preferred stock | — | 125,000 | |||||
Proceeds from initial public offering, net of issuance costs | 80,213 | — | |||||
Proceeds from the exercise of stock options | 18 | 219 | |||||
Deferred offering costs | (1,047 | ) | (57 | ) | |||
Payment of issuance costs | — | (150 | ) | ||||
Cash provided by financing activities | 79,184 | 125,012 | |||||
Net change in cash, cash equivalents, and restricted cash | (6,694 | ) | 89,734 | ||||
Cash, cash equivalents, and restricted cash at beginning of year | 47,964 | 20,101 | |||||
Cash, cash equivalents, and restricted cash at end of period | $ | 41,270 | $ | 109,835 |