Release Date: October 31, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- INmune Bio Inc (INMB, Financial) successfully closed enrollment for its global Phase II trial of XPro in Alzheimer's disease, marking a significant milestone.
- The company demonstrated strong operational capabilities by managing a complex clinical trial across 8 countries and 30 sites.
- INKmune, a novel NK-focused cancer program, showed consistent immunologic effects and an excellent safety profile in its Phase I/II trial for metastatic castrate-resistant prostate cancer.
- INmune Bio Inc (INMB) raised $13 million in gross proceeds from a registered direct equity offering, strengthening its financial position.
- The company has sufficient cash to fund operations into the third quarter of 2025, providing financial stability for ongoing and future projects.
Negative Points
- Net loss attributable to common stockholders increased to approximately $12.1 million for the quarter, compared to $8.6 million in the same period last year.
- Research and development expenses rose significantly to $10.1 million, up from $6 million in the previous year, indicating increased spending.
- The company faces challenges in patient enrollment for its Alzheimer's trial due to the need for specific inflammatory biomarkers.
- There is uncertainty regarding the regulatory pathway for XPro, particularly concerning the use of biomarkers in a potential Phase III trial.
- INmune Bio Inc (INMB) has no deep-seated business development discussions in place, with potential partnerships likely hinging on future data outcomes.
Q & A Highlights
Q: In the XPro Phase II Alzheimer's trial, how selective have you been with patient enrollment, and will this be a challenge for a potential Phase III trial?
A: Raymond Tesi, CEO, explained that they focus on patients with inflammation driving their Alzheimer's Disease, which is about 50% of patients. This strategy helps de-risk the clinical trial. The regulatory aspect will be discussed with the FDA after Phase II, but they are confident in managing it. CJ Barnum, VP of Drug Development, added that the selectivity is more about ensuring similar pathology in early phase studies.
Q: Could the timing of the Alzheimer's trial data readout be pushed to later in Q2 due to patients still in screening?
A: Raymond Tesi confirmed that while there are a few extra patients in screening, the drop-dead date for enrollment is about 10 days away. They are comfortable with the Q2 timeline for data release, provided the clinical operations team ensures clean and correct data.
Q: How does the recent acquisition of Aliada by AbbVie impact your thinking about potential M&A in the Alzheimer's space?
A: Raymond Tesi stated that most M&A activity is in the amyloid or tau path, and they believe once they show that targeting glial activation makes a difference, conversations will start. Currently, there are no deep-seated business development discussions, as it's all about data.
Q: Regarding the depression study, are the inflammatory biomarkers the same as those in Alzheimer's Disease?
A: CJ Barnum explained that they are enriching for patients with inflammation using blood C-reactive protein and a behavioral biomarker of anhedonia. These biomarkers are consistent across their programs, with about 40% to 50% of patients meeting the criteria.
Q: What do you need to see in the INKmune trial to justify continued investment, specifically regarding tumor impact?
A: Mark Lowdell, CSO, stated that they are looking for changes in immune response against tumors. They have some evidence of tumor shrinkage, and any clinical outcome convincing the chief investigator of a response would justify further investment. Raymond Tesi added that a therapy prolonging life with good quality is important, especially for older patients who can't tolerate traditional regimens.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
