Inmune Bio ((INMB)) has held its Q2 earnings call. Read on for the main highlights of the call.
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The recent earnings call from Inmune Bio painted a mixed picture, highlighting both significant advancements and notable challenges. On the one hand, the company showcased promising progress with its therapeutic platforms, including XPro, CORDStrom, and INKmune, which hold potential for groundbreaking treatments. On the other hand, the financial losses and the decision to halt the immediate development of XPro due to unmet primary endpoints in the Phase II trial underscore the hurdles the company faces.
XPro Phase II MINDFuL Trial Success
The Phase II MINDFuL trial has provided encouraging results for Inmune Bio’s XPro, particularly in patients with Alzheimer’s disease who exhibit two or more biomarkers of inflammation. This finding supports the hypothesis that XPro is especially beneficial for Alzheimer’s patients with elevated inflammation, reinforcing its potential as a targeted therapeutic option.
CORDStrom Progress
Inmune Bio is making strides with CORDStrom, focusing on obtaining approval in the U.K. and U.S. for treating Recessive Dystrophic Epidermolysis Bullosa (RDEB). The company plans to file for approval by midyear 2026. Additionally, CORDStrom shows promise for treating other forms of EB and potentially other indications, broadening its therapeutic scope.
INKmune Safety and Benefits
The Phase I/II program for INKmune is nearing completion, demonstrating both safety and immunologic benefits. The treatment is most effective when administered early in the disease course, particularly targeting residual disease, which could enhance patient outcomes significantly.
XPro Phase II Trial Did Not Meet Primary Endpoint
Despite the promising subgroup results, the XPro Phase II trial did not meet its primary endpoint in the overall population, primarily due to the placebo group not declining as expected. However, significant benefits were observed in a subgroup of Alzheimer’s patients with a high burden of inflammation, suggesting a potential path forward.
Financial Losses
Inmune Bio reported a net loss of approximately $24.5 million for the quarter ended June 30, 2025, a significant increase from $9.7 million in the previous year. This was largely due to the impairment of acquired in-process research and development intangible assets, amounting to $16.5 million.
XPro Program Development Halted
Following the Phase II MINDFuL data, Inmune Bio has decided to halt immediate development plans for XPro in Alzheimer’s disease due to the high cost of a Phase III program. The company is now seeking strategic partnerships to advance the program further.
Forward-Looking Guidance
Inmune Bio’s forward-looking guidance highlighted their strategic focus on advancing their therapeutic platforms. The company is preparing for an end of Phase II meeting with the FDA for XPro, expected before the year’s end, and is exploring partnerships to continue its development. Financially, with cash and cash equivalents of $33.4 million, the company expects to fund operations into Q3 2026. Efforts are also underway to secure approval for CORDStrom and advance the INKmune program, targeting earlier-stage diseases in future trials.
In conclusion, Inmune Bio’s earnings call reflects a company at a crossroads, with promising therapeutic advancements tempered by financial challenges and strategic shifts. The progress with XPro, CORDStrom, and INKmune showcases potential breakthroughs, while the financial losses and halted development plans highlight the need for strategic partnerships and careful resource management moving forward.