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 |
Dated: | May 13, 2019 | TCR2 Therapeutics Inc. | ||
By: | /s/ Mayur (Ian) Somaiya | |||
Mayur (Ian) Somaiya | ||||
Chief Financial Officer |
• | Initiated Phase 1/2 clinical trial for TC-210, TCR2’s lead product candidate targeting mesothelin expressing solid tumors |
• | On track to file an IND for TCR2’s lead hematology product candidate, TC-110, in patients with CD19+ non-Hodgkin lymphomas and leukemias in 2H 2019 |
• | Recent publication in Nature Communications and scientific presentations highlight advantages of the Company’s TRuCTM-T cell platform |
• | Established occupancy of manufacturing suite at Cell and Gene Therapy Catapult in the UK |
• | In January 2019, the FDA cleared the IND for TC-210. TCR2 initiated its Phase 1/2 trial to treat patients with mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma. TCR2 anticipates providing an update on the trial before the end of the 2019. |
• | In February 2019, TCR2 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. |
• | In February 2019, the FDA granted orphan drug designation to TC-210 for the treatment of mesothelioma. |
• | In February 2019, TCR2 held a pre-IND meeting with the FDA and remains on track to submit an IND for TC-110 in patients with CD19+ non-Hodgkin lymphomas and leukemias 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 TCR2’s TRuC-T cells that express anti-mesothelin TCR fusion proteins, including TC-210. |
• | In March 2019, TCR2 presented two poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2019 featuring preclinical data for TC-110 and TC-210. |
• | In March 2019, TCR2 established occupancy of its manufacturing suite at Cell and Gene Therapy (CGT) Catapult in the UK. |
• | In May 2019, TCR2 published preclinical data in the peer-reviewed journal Nature Communications demonstrating the advantages of TRuC-T cells compared to CAR-T cells. In the paper entitled, "Synthetic TRuC receptors engaging the complete T cell receptor for potent anti-tumor response," the findings, consistent with the Company’s previously reported preclinical data, support the Company’s belief that its product candidates could improve the observed efficacy and safety of other adoptive T-cell therapies in development. |
• | 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. The trial is enrolling patients with mesothelin expressing non-small cell lung cancer (NSCLC), ovarian cancer, cholangiocarcinoma, and 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 will be first tested 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 assessment of patients’ tissues for expansion, trafficking, and persistence of TC-210 T cells. |
• | In the Phase 2 portion of the clinical trial, approximately 50 patients are 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. |
• | Keystone Symposia on Molecular and Cellular Biology: Cancer Immunotherapy |
◦ | Robert Hofmeister, Ph.D., Chief Scientific Officer, delivered an oral presentation, "Preclinical Evaluation of TC-210, a Mesothelin-Specific T Cell Receptor (TCR) Fusion Construct (TRuCTM) T Cells for the Treatment of Solid Tumors." |
• | AACR Annual Meeting 2019 |
◦ | The Company presented two posters on the preclinical evaluation of TC-210 and TC-110 demonstrating superior in vivo anti-tumor activity compared to CAR-T cells with the same binders, including evidence that the anti-tumor activity of TRuC-T cells, both in vitro and in vivo, does not require added co-stimulatory signals. |
• | CAR-T Congress USA 2019 |
◦ | Robert Hofmeister, Ph.D., Chief Scientific Officer, delivered an oral presentation on the features of the TRuC-T cell platform, "Utilizing the Entire T Cell Receptor Independent of HLA for a Broad and Controlled Anti-Tumor Response." |
• | Nature Communications |
◦ | The Company published preclinical data demonstrating the advantages of TRuC-T cells compared to CAR-T cells. In the paper entitled, "Synthetic TRuC receptors engaging the complete T cell receptor for potent anti-tumor response," the findings, consistent with the TCR2’s previously reported preclinical data, support the Company’s belief that its product candidates could improve the observed efficacy and safety of other adoptive T-cell therapies in development. |
• | Cash Position: TCR2 ended 1Q 2019 with $191.7 million in cash, cash equivalents, and investments compared to $123.2 million as of December 31, 2018. Net cash from the Company’s initial public offering in 1Q 2019 was $80.2 million. Net cash used in operations was $10.8 million for 1Q 2019 compared to $3.0 million in 1Q 2018. TCR2 projects net cash use of $45-55 million in 2019. |
• | R&D Expenses: Research and development expenses were $7.9 million for the first quarter of 2019 compared to $2.9 million for the first 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 $2.9 million for the first quarter of 2019 compared to $1.2 million for the first 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 $9.9 million for the first quarter of 2019 compared to $4.0 million for the first quarter of 2018, driven predominantly by increased R&D expense in the quarter. |
• | Jefferies Global Healthcare Conference: Alfonso Quintás Cardama, M.D., Chief Medical Officer and Ian Somaiya, Chief Financial Officer, will present on Wednesday, June 5th, 2019 at 10:30am ET in New York, NY. |
• | BMO 2019 Prescriptions for Success Healthcare Conference: Robert Hofmeister, Ph.D., Chief Scientific Officer, will present on Thursday, June 25, 2019 at 3:40pm ET in New York, NY. |
March 31, 2019 | December 31, 2018 | ||||||
Assets | |||||||
Current assets | |||||||
Cash and cash equivalents | $ | 46,405 | $ | 47,674 | |||
Investments | 115,251 | 75,493 | |||||
Prepaid expenses and other current assets | 3,929 | 2,326 | |||||
Total current assets | 165,585 | 125,493 | |||||
Property and equipment, net | 1,936 | 1,638 | |||||
Investments, non-current | 30,048 | — | |||||
Restricted cash | 290 | 290 | |||||
Deferred offering costs | — | 2,012 | |||||
Total assets | $ | 197,859 | $ | 129,433 | |||
Liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) | |||||||
Accounts payable | $ | 2,830 | $ | 2,663 | |||
Accrued expenses and other current liabilities | 2,527 | 2,802 | |||||
Total current liabilities | 5,357 | 5,465 | |||||
Other liabilities | 455 | 434 | |||||
Total liabilities | 5,812 | 5,899 | |||||
Redeemable convertible preferred stock | |||||||
Series A preferred stock, $0.0001 par value; no shares and 45,000,000 authorized at March 31, 2019 and December 31, 2018; no shares and 44,500,001 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively. | — | 72,980 | |||||
Series B preferred stock, $0.0001 par value; no shares and 62,500,000 authorized at March 31, 2019 and December 31, 2018, respectively; no shares and 62,500,000 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively. | — | 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 March 31, 2019 and December 31, 2018, respectively. | — | — | |||||
Common stock, $0.0001 par value; 150,000,000 and 20,988,730 shares authorized at March 31, 2019 and December 31, 2018, respectively; 23,940,025 and 914,602 shares issued at March 31, 2019 and December 31, 2018, respectively; 23,792,193 and 726,994 shares outstanding at March 31, 2019 and December 31, 2018, respectively. | 2 | — | |||||
Additional paid-in capital | 336,939 | — | |||||
Accumulated other comprehensive income (loss) | 1 | (106 | ) | ||||
Accumulated deficit | (144,895 | ) | (85,590 | ) | |||
Total stockholders’ equity (deficit) | 192,047 | (85,696 | ) | ||||
Total liabilities, redeemable preferred stock and stockholders’ equity (deficit) | $ | 197,859 | $ | 129,433 |
Three Months Ended March 31, | |||||||
2019 | 2018 | ||||||
Operating expenses | |||||||
Research and development | $ | 7,889 | $ | 2,893 | |||
General and administrative | 2,886 | 1,220 | |||||
Total operating expenses | 10,775 | 4,113 | |||||
Loss from operations | (10,775 | ) | (4,113 | ) | |||
Interest income, net | 872 | 127 | |||||
Net loss | (9,903 | ) | (3,986 | ) | |||
Accretion of redeemable convertible preferred stock to redemption value | (49,900 | ) | (10,833 | ) | |||
Net loss attributable to common stockholders | $ | (59,803 | ) | $ | (14,819 | ) | |
Per share information | |||||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (4.85 | ) | $ | (28.90 | ) | |
Weighted average shares outstanding, basic and diluted | 12,328,805 | 512,685 |
Three Months Ended March 31, | |||||||
2019 | 2018 | ||||||
Operating activities: | |||||||
Net loss | $ | (9,903 | ) | $ | (3,986 | ) | |
Adjustments to reconcile net loss to cash used in operating activities: | |||||||
Depreciation and amortization | 135 | 76 | |||||
Stock-based compensation expense | 1,141 | 283 | |||||
Accretion on investments | (131 | ) | (18 | ) | |||
Changes in operating assets and liabilities: | |||||||
Interest receivable on investments | (157 | ) | (51 | ) | |||
Prepaid expenses and other current assets | (1,207 | ) | 583 | ||||
Accounts payable | (401 | ) | 221 | ||||
Accrued expenses and other liabilities | (310 | ) | (120 | ) | |||
Cash used in operating activities | (10,833 | ) | (3,012 | ) | |||
Investing activities: | |||||||
Purchase of investments | (86,626 | ) | (13,369 | ) | |||
Proceeds from maturity of investments | 16,819 | — | |||||
Purchases of equipment | (188 | ) | (368 | ) | |||
Cash used in investing activities | (69,995 | ) | (13,737 | ) | |||
Financing activities: | |||||||
Proceeds from the sale of Series B preferred stock | — | 120,000 | |||||
Proceeds from initial public offering, net of issuance costs | 80,213 | — | |||||
Proceeds from the exercise of stock options | — | 219 | |||||
Deferred offering costs | (654 | ) | (3 | ) | |||
Payment of issuance costs | — | (150 | ) | ||||
Cash provided by financing activities | 79,559 | 120,066 | |||||
Net change in cash, cash equivalents, and restricted cash | (1,269 | ) | 103,317 | ||||
Cash, cash equivalents, and restricted cash at beginning of year | 47,964 | 20,101 | |||||
Cash, cash equivalents, and restricted cash at end of period | $ | 46,695 | $ | 123,418 |