Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 38

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 38
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 affects no more than 50 in
100,000 persons in the European Union; without incentive it is unlikely that the drug would generate sufficient return to justify the
necessary investment; and no satisfactory method of treatment for the condition exists or, if it does, the new drug will provide a significant
benefit to those affected by the condition. If a product that has an orphan drug designation subsequently receives the first regulatory
approval for the indication for which it has such designation, the product is entitled to orphan exclusivity, meaning that the applicable
regulatory authority may not approve any other applications to market the same drug for the same indication, except in limited circumstances,
for a period of seven years in the United States and 10 years in the European Union Orphan drug designation does not prevent competitors
from developing or marketing different drugs for the same indication or the same drug for different indications. Orphan drug designation
must be requested before submitting an NDA. After orphan drug designation is granted, the identity of the therapeutic agent and its potential
orphan use are publicly disclosed. Orphan drug designation does not convey an advantage in, or shorten the duration of, the review and
approval process. However, this designation provides an exemption from marketing and authorization (“NDA”) fees. We plan to follow a similar
path with INB03 or XPro, although the precise indication cannot be determined until we are farther along in the development process.

Clinical Trials

Phase 1 clinical trials typically
involve the initial introduction of the product candidate into healthy human volunteers. In Phase 1 clinical trials, the product candidate
is typically tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and pharmacodynamics.

Phase 2 clinical trials are
conducted in a limited patient population to gather evidence about the efficacy of the product candidate for specific, targeted indications;
to determine dosage tolerance and optimal dosage; and to identify possible adverse effects and safety risks.

Phase 3 clinical trials are
undertaken to evaluate clinical efficacy and to test for safety in an expanded patient population at geographically dispersed clinical
trial sites. The size of Phase 3 clinical trials depends upon clinical and statistical considerations for the product candidate and disease,
but sometimes can include several thousand patients. Phase 3 clinical trials are intended to establish the overall risk-benefit ratio
of the product candidate and provide an adequate basis for product labeling.

Clinical trials involve the
administration of the product candidate to human subjects under the supervision of qualified medical investigators according to approved
protocols that detail