INmune Bio’s Earnings Call: Promise and Challenges

Inmune Bio ((INMB)) has held its Q1 earnings call. Read on for the main highlights of the call.

The recent earnings call for INmune Bio revealed a mix of optimism and caution. While the company announced promising developments in their drug programs and regulatory advancements, financial constraints and delays in regulatory filings tempered the overall sentiment. The call highlighted the company’s optimism about upcoming milestones, yet financial sustainability remains a pressing concern.

Increased Market Opportunity for XPro in Alzheimer’s

The market potential for XPro, a drug aimed at treating early Alzheimer’s disease, has significantly expanded. Recent data suggests that nearly 70% of early Alzheimer’s patients could benefit from XPro, a notable increase from the previous estimate of 40%. This expansion is attributed to more patients being eligible based on their ApoE4 status, indicating a substantial opportunity for growth in this segment.

Positive Safety Profile of XPro

XPro continues to demonstrate a strong safety profile, particularly in the MINDFuL trial. The absence of adverse events or deaths among the elderly Alzheimer’s patient population underscores the drug’s safety, making it a viable option for this vulnerable group. This positive safety data is crucial for the drug’s future development and market acceptance.

Progress in INKmune Program

The INKmune program has made significant strides, completing Phase 1 dose escalation cohorts without any adverse events. Phase 2 is currently underway, showing promising early results in prostate cancer patients, including some tumor lesion resolution. These developments indicate potential for INKmune in oncology, particularly for prostate cancer treatment.

Advancement in CORDstrom Development

CORDstrom is on track for a Biologics License Application (BLA) filing in 2026, aimed at treating recessive dystrophic epidermolysis bullosa (RDEB). The program is bolstered by positive trial results and the FDA’s designation of rare pediatric disease and orphan drug status, which could expedite its path to market.

Limited Cash Runway

Despite these promising developments, INmune Bio faces financial challenges. With cash and cash equivalents totaling approximately $19.3 million, the company has enough resources to fund operations only through the third quarter of 2025. This limited cash runway poses a significant challenge to the company’s ongoing and future projects.

Delays in U.S. IND for CORDstrom

The initiation of the U.S. Investigational New Drug (IND) application for CORDstrom has encountered delays, primarily due to funding issues. Despite these setbacks, the company remains committed to a BLA filing in 2026, although these delays could impact the program’s timeline.

Forward-Looking Guidance

Looking ahead, INmune Bio’s management remains optimistic about several key milestones. The anticipated topline results from the MINDFuL Phase 2 trial in early Alzheimer’s disease are expected by mid-to-late June. The company also highlighted the increased market opportunity for XPro and its strong safety profile. Financially, the company reported a net loss of approximately $9.7 million for the quarter, with research and development expenses at $7.6 million. The cash reserves are expected to sustain operations through Q3 2025, but further funding will be necessary to continue their ambitious programs.

In conclusion, INmune Bio’s earnings call presented a mixed picture of potential and challenges. While the company is making significant strides in drug development and regulatory progress, financial constraints and delays pose hurdles. The overall sentiment is cautiously optimistic, with a focus on achieving upcoming milestones and addressing financial sustainability.