Overview of the Company’s Financial Performance

Crispr Therapeutics (CRG) is a clinical-stage biotechnology company focused on developing next-generation cell therapies for cancer patients. The company has incurred significant operating losses and negative cash flows since its inception, with a net loss of $167.5 million in 2024 and $98.1 million in 2023. As of December 31, 2024, CRG had an accumulated deficit of $312.6 million and $368.1 million in cash, cash equivalents, and marketable securities.

CRG’s primary focus is on advancing its lead product candidate, CRG-023, an investigational tri-specific CAR T-cell therapy designed to address limitations of existing CAR T-cell therapies. The company plans to initiate a Phase 1 clinical trial for CRG-023 in 3L+ large B-cell lymphoma in the second quarter of 2025. CRG is also developing a novel allogeneic platform to enable off-the-shelf CAR T-cell therapies and intends to pursue an allogeneic version of CRG-023.

In January 2025, CRG discontinued its Phase 2 study of its previous lead program, firicabtagene autoleucel (firi-cel), and is now evaluating strategic options for the company.

Revenue and Profit Trends

CRG has not generated any revenue from product sales since its inception, as the company’s product candidates are still in clinical development. The company’s operating expenses consist primarily of research and development (R&D) expenses and general and administrative (G&A) expenses.

R&D expenses increased from $75.8 million in 2023 to $143.4 million in 2024, a 89% increase. This was driven by a $29.4 million increase in manufacturing costs, a $10.9 million increase in preclinical and clinical costs, a $19.1 million increase in employee-related costs, and a $9.7 million increase in facilities and other operating costs. These increases were partially offset by a $1.2 million decrease in license fees.

G&A expenses also increased significantly, from $20.9 million in 2023 to $44.0 million in 2024, a 110% increase. This was primarily due to a $16.2 million increase in employee-related costs, a $3.9 million increase in facilities and other operating costs, and a $3.0 million increase in outside services costs.

The substantial increases in both R&D and G&A expenses resulted in a net loss of $167.5 million in 2024, compared to a net loss of $98.1 million in 2023.

Analysis of Strengths and Weaknesses

Strengths:

• Promising lead product candidate, CRG-023, with the potential to address limitations of existing CAR T-cell therapies
• Advancing a novel allogeneic platform to enable off-the-shelf CAR T-cell therapies
• Significant cash position of $368.1 million as of December 31, 2024, which the company estimates will be sufficient to fund operations through mid-2028
• Experienced management team and strong intellectual property portfolio

Weaknesses:

• Significant and increasing net operating losses, with a net loss of $167.5 million in 2024
• Heavy reliance on external contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs) for clinical development and manufacturing
• Discontinuation of the company’s previous lead program, firi-cel, and the need to evaluate strategic options
• Lack of revenue from product sales, as the company’s product candidates are still in clinical development

Outlook and Future Prospects

CRG’s future prospects will largely depend on the successful development and commercialization of its lead product candidate, CRG-023, as well as the progress of its allogeneic platform. The company’s significant cash position provides a runway to advance its pipeline, but it will need to continue to raise additional capital to fund its ongoing operations and future development efforts.

The initiation of the Phase 1 clinical trial for CRG-023 in the second quarter of 2025 will be a key milestone for the company, as positive results could support the advancement of the program into earlier lines of therapy and expansion into additional B-cell malignancies. The development of the allogeneic platform also holds promise, as it could enable the creation of off-the-shelf CAR T-cell therapies and potentially broaden the availability of these treatments to more cancer patients.

However, the company’s decision to discontinue the firi-cel program and the need to evaluate strategic options introduces uncertainty and risk. The company will need to carefully manage its resources and prioritize its pipeline to ensure the successful development of CRG-023 and the allogeneic platform.

Overall, CRG’s financial performance reflects the significant investments required for the development of novel cell therapies. While the company’s cash position provides a solid foundation, it will need to continue to raise additional capital and execute its development plans effectively to achieve its long-term goals and deliver value to shareholders.