IN8bio, Inc. (NASDAQ:INAB) is a clinical-stage biopharmaceutical company leading the charge in the development of innovative gamma-delta T cell therapies for the treatment of solid and liquid tumors. The company's strategic decision to narrow its focus to its most promising program, INB-100 for acute myeloid leukemia (AML), highlights its commitment to efficiently allocating resources and maximizing shareholder value amidst a challenging financing environment.
Business Overview and History IN8bio has a complex corporate history that began with its formation as Incysus, Inc. in Delaware in November 2015. This was followed by the incorporation of Incysus, Ltd. in Bermuda in February 2016, with Incysus, Inc. as its wholly owned U.S. subsidiary. The company underwent several structural changes, including a reincorporation in the United States in May 2018 as Incysus Therapeutics, Inc., a merger with Incysus, Inc. in July 2019, and finally, a name change to IN8bio, Inc. in August 2020.
Since its inception, IN8bio has been dedicated to researching and developing gamma-delta T cell product candidates. The company's lead product, INB-100, has been the focus of an investigator-sponsored Phase 1 clinical trial for high-risk leukemia patients undergoing hematopoietic stem cell transplantation. Early results from this trial have been promising, with all evaluable leukemia patients showing sustained positive outcomes.
IN8bio's journey has not been without challenges. In September 2024, the company implemented a significant restructuring, which included suspending enrollment in the INB-400 Phase 2 clinical trial for newly diagnosed glioblastoma and reducing its workforce by approximately 49% across all functions. This decision was made to conserve resources and concentrate efforts on the advancement of the INB-100 program for AML.
Despite these hurdles, IN8bio has continued to make strides in developing its gamma-delta T cell technology. The company's portfolio includes preclinical programs such as INB-200 and INB-300, which utilize its proprietary DeltEx platform. Additionally, IN8bio has expanded its capabilities to include the development of induced pluripotent stem cell (iPSC) derived gamma-delta T cells, potentially paving the way for off-the-shelf cellular therapies.
Financial Overview IN8bio's financial performance has been consistent with the nature of its clinical-stage operations. For the fiscal year ended December 31, 2023, the company reported no revenue and a net loss of $30.0 million, or $1.00 per share. This was in line with the previous fiscal year's net loss of $28.5 million, or $1.36 per share. The company's cash position as of September 30, 2024, stood at $4.0 million, supplemented by the recent private placement, which raised net proceeds of $11.6 million, extending the cash runway through 2025.
In the most recent quarter (Q3 2024), IN8bio reported no revenue and a net loss of $7.1 million. The operating cash flow for the quarter was negative $6.1 million, while free cash flow was negative $6.0 million. These figures reflect the company's continued investment in research and development activities, including ongoing clinical trials, and underscore the pre-revenue stage of the business.
Liquidity As of September 30, 2024, IN8bio's cash position stood at $4.0 million. The company's debt-to-equity ratio was 0.64, indicating a moderate level of leverage. The current ratio and quick ratio were both 1.84, suggesting that the company has sufficient short-term assets to cover its near-term liabilities.
The recent private placement, which raised net proceeds of $11.6 million, has extended the company's cash runway through 2025. These funds are crucial for supporting ongoing operations and advancing the lead program, INB-100 for AML. It's worth noting that the company did not disclose any available credit facilities or credit lines in the provided information.
Streamlining the Pipeline In September 2024, IN8bio announced a strategic restructuring to focus the company's resources on the advancement of its lead program, INB-100 for AML. As part of this initiative, the company suspended enrollment in the Phase 2 clinical trial of INB-400 for newly diagnosed GBM, while continuing to monitor patients in both the INB-400 and INB-200 trials for long-term remissions and overall survival.
This narrowing of the pipeline was accompanied by a 49% reduction in the workforce, along with an 11% reduction in cash compensation for the board and management team. The goal of these cost-saving measures is to preserve the company's resources and ensure the successful execution of the INB-100 program, which has demonstrated remarkable results in the ongoing Phase 1 trial.
Upcoming Milestones and Catalysts IN8bio's strategic focus on INB-100 for AML is expected to drive significant value creation for the company. The expansion cohort of the INB-100 trial is currently enrolling additional patients, and the company plans to present updated data at the American Society of Hematology (ASH) Annual Meeting in December 2024. Furthermore, the company received regulatory guidance from the FDA to advance INB-100 as a post-transplant maintenance therapy for AML, with relapse-free survival as the primary endpoint.
In addition to the INB-100 program, IN8bio will also be showcasing its progress in the INB-200 trial for GBM at the Society for Neuro-Oncology (SNO) Annual Meeting in November 2024. The company will provide longer-term follow-up and additional data demonstrating the activity of its DRI gamma-delta T cell approach in solid tumors.
Risks and Challenges As a clinical-stage biopharmaceutical company, IN8bio faces the inherent risks associated with the development and commercialization of novel therapies. The success of its pipeline, particularly INB-100 for AML, is critical to the company's long-term growth and profitability. Additionally, the highly competitive nature of the oncology landscape and the company's dependence on third-party collaborations and manufacturing partners present ongoing challenges.
Furthermore, the company's ability to raise additional capital to fund its operations remains a key concern, as evidenced by the recent private placement. The company's cash position and ongoing cash burn rate will need to be closely monitored to ensure the successful advancement of its lead program. The accumulated deficit of $115.5 million as of September 30, 2024, underscores the significant investment required in the development of novel therapies and the importance of achieving clinical and commercial milestones to secure future funding.
Conclusion IN8bio's decision to narrow its focus to the INB-100 program for AML underscores the company's commitment to efficiently allocating resources and driving value for its shareholders. The promising results observed in the ongoing Phase 1 trial, coupled with the regulatory guidance received from the FDA, position INB-100 as a compelling asset in the company's pipeline.
As IN8bio continues to execute its strategic plan, the upcoming data presentations at the ASH and SNO annual meetings will be crucial in demonstrating the company's progress and the potential of its innovative gamma-delta T cell therapies. Investors will closely monitor the company's ability to navigate the challenges of the clinical development process and secure the necessary funding to advance its lead program. With a renewed focus and streamlined approach, IN8bio is well-positioned to capitalize on the vast potential of its unique technology and deliver meaningful outcomes for patients battling cancer.