Saturday, November 12, 2022 9:28:24 PM
https://www.abc4.com/business/press-releases/globenewswire/8692169/tscan-therapeutics-reports-third-quarter-2022-financial-results-and-provides-business-update/
WALTHAM, Mass., Nov. 09, 2022 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today reported financial results and provided a business update for the third quarter ended September 30, 2022.
“We continued to make meaningful progress across the entirety of our pipeline during the third quarter and look forward to providing an update on our Phase 1 clinical trial by the end of this year. We plan to commence clinical development for the solid tumor program with multiple TCRs next year,” said David P. Southwell, President and Chief Executive Officer. “On the financing side, we are pleased to have secured a debt facility for up to $60 million with K2 HealthVentures during the third quarter. The initial $30 million that we drew at the close provides TScan with a cash runway into the second quarter of 2024.”
Debora Barton, M.D., Chief Medical Officer added: “Based on recent FDA interactions, we have a clear path to file INDs for multiple solid tumor TCRs and to conduct a Phase 1 umbrella trial which will enable us to bring our ImmunoBank of highly selective TCRs to patients. We look forward to sharing further details on our solid tumor program development plans during a virtual event later this month.”
Recent Corporate Highlights
During the quarter TScan announced the closing of a convertible debt facility for up to $60 million with K2 HealthVentures (K2HV). The initial $30 million provided at close, in addition to the current cash on hand, extends the Company’s cash runway into the second quarter of 2024. The Company has the option to draw the remaining tranches subject to certain conditions and by mutual agreement of TScan and K2HV to further support development of additional programs and/or business development.
TScan will present two posters at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting:
Multiplexed TCR-T cell therapy targeting MAGE-A1 and PRAME enhances the activity of adoptive T cell therapy in pre-clinical models; Thursday, November 10, 2022, from 9:00am-9:00pm ET, Exhibition Hall C
Discovery of TSC-203-A02: A PRAME-specific TCR-T cell therapy candidate for the treatment of solid tumors; Friday, November 11, 2022, from 9:00am-8:30pm ET, Exhibition Hall C
TScan has successfully completed a pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding the manufacturing, preclinical and clinical development plans for its solid tumor program. The FDA has provided feedback to TScan regarding T-Plex, its customized TCR-T cell product mixture, a collection of two to three TCRs selected from the ImmunoBank based on a patient’s tumor antigen positivity and HLA expression.
The Company is hosting a virtual investor event Monday, November 14, 2022, at 5:00 p.m. ET to provide an in-depth review of the poster presentations at the SITC Annual Meeting related to solid tumor TCR-T candidates, clinical development plans, and TScan’s approach to multiplexed therapy as a way to potentially overcome antigen heterogeneity and HLA loss. Registration for the live event can be found here. A replay will be available on the “Events and Presentations” section of the Company’s website at ir.tscan.com.
Anticipated Near-Term and Upcoming Catalysts
Hematologic Malignancies Program: TScan’s two lead TCR-T therapy candidates, TSC-100 and TSC-101, are designed to target HA-1 and HA-2, respectively, to prevent relapse in acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myelodysplastic syndromes (MDS) patients undergoing allogeneic haploidentical hematopoietic cell transplantation (HCT) with reduced intensity conditioning (RIC). Up to 40% of patients who receive HCT with RIC relapse within two years after the transplant, at which point there are limited treatment options and poor prognosis. The longer-term objective is to enable more patients to maintain prolonged remission after HCT using RIC, a more tolerable chemotherapy than the myeloablative conditioning, followed by TScan’s TCR-T.
The Phase 1 umbrella trial (NCT05473910) for TSC-100 and TSC-101 is open for enrollment, and the Company will provide a progress update at the 64th American Society of Hematology (ASH) Annual Meeting:
Trial in Progress: A Phase 1 Umbrella Study of TCR-Engineered T Cells That Target HA-1 (TSC-100) and HA-2 (TSC-101) to Treat Residual Leukemia After Hematopoietic Cell Transplantation; Sunday, December 11, 2022, from 6:00-8:00pm CT, Ernest N. Morial Convention Center, Hall D
The Company expects to enroll the first two cohorts in this trial in the first half of 2023 and plans to report interim data for this study by the end of 2023.
Solid Tumor Programs: TScan’s TCR-T therapy candidates for solid tumors include a combination of validated targets, such as MAGE-A1 (TSC-204), HPV16 E7 (TSC-200), and PRAME (TSC-203), as well as novel targets for TCR-T therapy, such as those for TSC-201 and TSC-202. To address resistance that can arise from HLA loss and to provide therapeutic options for a diverse patient population, TScan is also developing TCRs for multiple HLAs across all of its targets.
The Company plans to progress IND-enabling studies for its solid tumor programs and submit IND applications for two MAGE-A1 TCRs (TSC-204-A2 and TSC-204-C7) by the end of 2022.
The Company plans to file INDs for HPV (TSC-200-A2) and PRAME (TSC-203-A2) in the first half of 2023 with two additional INDs to be filed by the end of 2023. The Company expects to release preliminary clinical safety data for the most advanced TCRs by the end of 2023.
Third Quarter 2022 Financial Results
As of September 30, 2022, TScan Therapeutics had cash and cash equivalents of $137.3 million, excluding $5.0 million of restricted cash. Based on current operating plans, the Company believes that existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into the second quarter of 2024.
Revenue for the third quarter ended September 30, 2022, was $3.4 million, compared to $2.4 million for the third quarter ended September 30, 2021 (2021 Quarter). This increase is due to research activities related to TScan’s collaboration agreement with Novartis Institutes for Biomedical Research, which commenced in September 2020.
Research and development expenses for the third quarter ended September 30, 2022, were $15.0 million, compared to $14.2 million for the 2021 Quarter. The increase of $0.8 million was primarily driven by increased personnel expense and an increase in clinical study expenses as the Company advances its trials, partially offset by a decrease in preclinical expenses as the Company shifts its focus towards clinical development.
General and administrative expenses for the third quarter ended September 30, 2022, were $4.9 million, compared to $4.0 million for the 2021 Quarter. The increase of $0.9 million in general and administrative expenses was primarily driven by an increase in personnel expense related to growth to support the business.
For the third quarter ended September 30, 2022, TScan Therapeutics reported a net loss of $16.2 million, compared to a net loss of $15.8 million for the 2021 Quarter.
As of September 30, 2022, the Company had issued and outstanding shares of 24,074,927.
Recent TCRX News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/14/2024 08:20:09 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/14/2024 08:20:04 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 06/14/2024 08:05:34 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/14/2024 11:15:02 AM
- TScan Therapeutics Announces Updates to its Board of Directors • GlobeNewswire Inc. • 06/14/2024 11:00:00 AM
- TScan Therapeutics Announces Upcoming Presentation at the Jefferies Global Healthcare Conference • GlobeNewswire Inc. • 05/30/2024 11:00:00 AM
- TScan Therapeutics Receives FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation for its Two Lead TCR-T Therapy Candidates for the Treatment of Heme Malignancies • GlobeNewswire Inc. • 05/29/2024 11:00:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/13/2024 11:30:28 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/13/2024 11:15:25 AM
- TScan Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update • GlobeNewswire Inc. • 05/13/2024 11:00:00 AM
- TScan Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating TCR-T Therapy for the Treatment of Solid Tumors • GlobeNewswire Inc. • 05/09/2024 11:00:00 AM
- TScan Therapeutics Announces Upcoming Presentations at the 2024 American Society of Clinical Oncology Annual Meeting • GlobeNewswire Inc. • 04/24/2024 08:05:34 PM
- TScan Therapeutics Announces Exercise of Underwriters' Option to Purchase Additional Shares • GlobeNewswire Inc. • 04/24/2024 03:03:30 PM
- TScan Therapeutics Announces Upcoming Presentations at the American Society of Gene and Cell Therapy 27th Annual Meeting • GlobeNewswire Inc. • 04/22/2024 09:01:23 PM
- TScan Therapeutics Announces Closing of Upsized Public Offering • GlobeNewswire Inc. • 04/19/2024 02:05:23 PM
- TScan Therapeutics Announces Pricing of Upsized $150 Million Public Offering • GlobeNewswire Inc. • 04/17/2024 04:30:57 AM
- TScan Therapeutics Announces Launch of $125 Million Proposed Public Offering • GlobeNewswire Inc. • 04/16/2024 08:25:22 PM
- TScan Therapeutics Provides Clinical Pipeline Update and Highlights Near-Term Priorities • GlobeNewswire Inc. • 04/16/2024 08:01:00 PM
- TScan Therapeutics Appoints Seasoned Hematology and Oncology Expert Chrystal U. Louis, M.D., M.P.H., as Chief Medical Officer • GlobeNewswire Inc. • 04/08/2024 12:00:00 PM
- TScan Therapeutics Announces Upcoming Presentation at the 23rd Annual Needham Virtual Healthcare Conference • GlobeNewswire Inc. • 04/02/2024 11:00:00 AM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 03/06/2024 09:11:41 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 03/06/2024 09:05:39 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/06/2024 12:30:34 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/06/2024 12:15:10 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/14/2024 09:45:41 PM
Last Shot Hydration Drink Announced as Official Sponsor of Red River Athletic Conference • EQLB • Jun 20, 2024 2:38 PM
ATWEC Announces Major Acquisition and Lays Out Strategic Growth Plans • ATWT • Jun 20, 2024 7:09 AM
North Bay Resources Announces Composite Assays of 0.53 and 0.44 Troy Ounces per Ton Gold in Trenches B + C at Fran Gold, British Columbia • NBRI • Jun 18, 2024 9:18 AM
VAYK Assembling New Management Team for $64 Billion Domestic Market • VAYK • Jun 18, 2024 9:00 AM
Fifty 1 Labs, Inc Announces Acquisition of Drago Knives, LLC • CAFI • Jun 18, 2024 8:45 AM
Hydromer Announces Attainment of ISO 13485 Certification • HYDI • Jun 17, 2024 9:22 AM