- TCR-T Library Phase 1/2 trial achieved an 83% disease control rate of six evaluable patients with metastatic, refractory solid tumors; TCR-T cell therapy was well tolerated in all evaluable patients
- Company to wind down TCR-T Library Phase 1/2 trial and concurrently explore potential partnering opportunities for the hunTR® platform as well as broad strategic alternatives
- Reducing headcount by approximately 60% while retaining key hunTR® R&D capabilities
“Over the past two years, we have advanced the medical field’s understanding of TCR-T cell therapies using our innovative Sleeping Beauty technology targeting high-frequency driver mutations,” said
Operational & Corporate Update
Interim Clinical Data from TCR-T Library Phase 1/2 Trial: Eight patients have been treated in the Company’s TCR-T Library Phase 1/2 trial to date, six of which are evaluable as of today. The trial showed that the Company’s T-cells were generally well-tolerated in all evaluable participants and achieved an 83% disease control rate in evaluable patients with metastatic, refractory solid tumors. Disease control is measured by objective responses and stable disease. Persistence of TCR-T cells in peripheral blood was detected in all evaluable patients at last follow-up.
hunTR® TCR Discovery Platform Identifies Proprietary TCRs: Alaunos has discovered multiple proprietary TCRs targeting driver mutations through its hunTR® TCR discovery platform. The hunTR® platform can rapidly interrogate T-cell responses and has the potential to expand to multiple targets or cancer indications. Using hunTR®, the Company has demonstrated the ability to isolate neoantigen specific TCRs from tumor resident T-cells. The presence of these driver mutation specific T-cells in the tumor potentially validates the relevance of the mutated target and safety of the TCR for use in other cancer patients expressing the same neoantigen.
Second Quarter Ended
Research and Development Expenses: Research and development expenses were
General and Administrative Expenses: General and administrative expenses were
Net Loss: Net loss was
Cash, Cash Equivalents and Restricted Cash: As of
About
Forward-Looking Statements Disclaimer
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as “may,” “will,” “could,” “expects,” “plans,” “anticipates,” “believes” or other words or terms of similar meaning. These statements include, but are not limited to, statements regarding the Company evaluating strategic alternatives and the potential outcomes; the completion and impact of the reduction in workforce; the planned renewed focus on the hunTR® TCR discovery platform and its success, including its ability to discover additional TCRs and the ability to monetize any newly discovered TCRs; the wind down of the TCR-T Phase 1/2 Library trial; and the results and potential of the TCR-T Phase 1/2 Library trial.. Although the management team of Alaunos believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Alaunos, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, among other things, risks relating to volatility and uncertainty in the capital markets for biotechnology and cell therapy companies; availability of suitable third parties with which to conduct contemplated strategic transactions; whether the Company will be able to pursue a strategic transaction, or whether any transaction, if pursued, will be completed successfully and on attractive terms or at all; whether our cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital requirements; changes in the Company’s operating plans that may impact its cash expenditures; the uncertainties inherent in research and development, future clinical data and analysis; the risks associated with reductions in workforce, including reduced morale and attrition of additional employees necessary for the strategic reprioritization; the Company’s exclusive focus on its hunTR® TCR discovery platform; the strength and enforceability of Alaunos’ intellectual property rights; competition from other pharmaceutical and biotechnology companies; the impacts related to or resulting from recent bank failures and other economic and industry volatility; and the potential delisting of the Company’s common stock from the
Investor Relations Contact:
Stern Investor Relations
Alex.lobo@sternir.com
Media Contact:
6 Degrees PR
handerson@6degreespr.com
Statement of Operations (In thousands except per share data) | ||||||
For the Three Months Ended (Unaudited) | ||||||
2023 | 2022 | |||||
Collaboration revenue | $ | 4 | $ | - | ||
Operating expenses: | ||||||
Research and development | $ | 5,186 | $ | 5,937 | ||
General and administrative | 3,045 | 3,429 | ||||
Gain on lease modification | (245 | ) | (133 | ) | ||
Total operating expenses | 7,986 | 9,233 | ||||
Loss from operations | (7,982 | ) | (9,233 | ) | ||
Interest expense | (1,068 | ) | (740 | ) | ||
Other income, net | 277 | 41 | ||||
Net loss | (8,773 | ) | (9,932 | ) | ||
Basic and diluted net loss per share | $ | (0.04 | ) | $ | (0.05 | ) |
Weighted average common shares outstanding, basic and diluted | 239,797,574 | 214,998,893 |
Selected Balance Sheet Data (In thousands) | ||||
2023 (Unaudited) | 2022 (Audited) | |||
Cash and cash equivalents | $ | 18,317 | $ | 39,058 |
Restricted cash | $ | - | $ | 13,938 |
Working capital, excluding restricted cash | $ | 13,726 | $ | 15,695 |
Total assets | $ | 27,927 | $ | 64,937 |
Total stockholders’ equity | $ | 21,650 | $ | 38,555 |
Source:
2023 GlobeNewswire, Inc., source