On March 11, 2021 TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from cancer, reported financial results for the fourth quarter ended December 31, 2020 and provided a corporate update (Press release, TCR2 Therapeutics, MAR 11, 2021, View Source [SID1234576474]).
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"2020 was a transformative year for TCR2, with initial clinical data on our lead program, gavo-cel, establishing our leadership position in solid tumors. On the back of encouraging RECIST responses in refractory mesothelioma and ovarian cancer, we were able to strengthen our balance sheet and diversify our investor base, extending our cash runway into 2024 to support our goal of saving the lives of cancer patients," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "We now look to accelerate the development of gavo-cel in 2021 by identifying the recommended Phase 2 dose, initiating the expansion portion of the trial and increasing our manufacturing capacity. We will also provide updates on our rapidly growing pipeline, most immediately with preclinical data presentations at the AACR (Free AACR Whitepaper) conference on our allogeneic mesothelin TRuC and our CD70 autologous TRuC."
Recent Developments
TCR2 reported a 38% Overall Response Rate with three RECIST partial responses (PRs) (2 confirmed and 1 unconfirmed PRs) from patients in the dose escalation portion of the gavo-cel Phase 1/2 clinical trial, including the first ovarian cancer patient to ever achieve a PR with an engineered cell therapy and one mesothelioma patient achieving a complete metabolic response.
TCR2 completed an upsized $140M follow-on offering.
TCR2 announced preliminary safety and efficacy data with a focus on translational data of gavo-cel in patients with treatment refractory mesothelin overexpressing solid tumors will be presented in an e-poster presentation at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting on Saturday, April 10, 2021.
TCR2 continues to treat patients in the dose escalation portion of the TC-110 Phase 1/2 clinical trial.
TCR2 announced new preclinical data from its allogeneic TRuC-T cell targeting mesothelin highlighting a lack of alloreactivity, reduced risk of host rejection, upregulation of activation markers, secretion of cytokines and clearance of tumors cells will be presented in an e-poster presentation at the AACR (Free AACR Whitepaper) Virtual Annual Meeting on Saturday, April 10, 2021.
TCR2 announced new preclinical data from its TRuC-T cell targeting CD70 highlighting T cell expansion, improved memory phenotype, significant anti-tumor efficacy in multiple xenograft mouse models with no evidence of in vivo fratricide will be presented in an e-poster presentation at the AACR (Free AACR Whitepaper) Virtual Annual Meeting on Saturday, April 10, 2021.
TCR2 announced the appointment of Shawn Tomasello to its Board of Directors. Ms. Tomasello served as Chief Commercial Officer of Kite Pharma where she oversaw the global commercialization of Yescarta, from 2015 to 2018 including through its acquisition by Gilead for $11.9 billion in October 2017.
Anticipated Milestones
TCR2 to present additional safety, efficacy and translational data from the Phase 1 portion of the gavo-cel Phase 1/2 clinical trial for patients with mesothelin-expressing solid tumors throughout 2021.
TCR2 to present an interim update from the Phase 1 portion of the TC-110 Phase 1/2 clinical trial for patients with CD19+ non-Hodgkin lymphoma or adult acute lymphoblastic leukemia in 2021.
TCR2 plans to file an IND for TC-510, the first enhanced TRuC-T cell targeting mesothelin with a PD-1:CD28 switch, in 2021.
TCR2 plans to select a development candidate for its allogeneic program in 2021.
TCR2 anticipates additional pipeline updates throughout 2021.
TCR2 anticipates production of gavo-cel clinical trial material from ElevateBio in 2021.
TCR2 anticipates MHRA certification of its manufacturing facility in Stevenage, UK, in mid-2021.
Financial Highlights
Cash Position: TCR2 ended 2020 with $228.0 million in cash, cash equivalents, and investments compared to $158.1 million as of December 31, 2019. Year-end 2020 cash balance does not reflect gross proceeds of $140 million from our equity offering in January. Net cash used in operations was $56.7 million for 2020 compared to $41.4 million for 2019. TCR2 projects net cash use of $80-90 million for 2021.
R&D Expenses: Research and development expenses were $52.0 million for 2020 compared to $37.5 million for 2019. The increase in R&D expenses is primarily related to increase in headcount, activities related to the Phase 1/2 clinical trial of gavo-cel and activities related to the Phase 1/2 clinical trial of TC-110.
G&A Expenses: General and administrative expenses were $16.7 million for 2020 compared to $13.9 million for 2019. The increase in general and administrative expenses was primarily due to an increase in personnel costs.
Net Loss: Net loss was $67.1 million for 2020 compared to $47.6 million for 2019, driven predominantly by increased personnel expenses.