Company: CMND
Filing Date: 2025-12-05
Form Type: F-1/A
Source: 0001213900-25-118772
Chunk: 83

Company: Clearmind Medicine Inc.
Filing Date: 2025-12-05
Form: F-1/A
Chunk 83
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 candidates, products, or necessary quantities of such materials on time or at an acceptable cost. We do not currently have, nor do we plan to acquire, the infrastructure or capability internally to manufacture drug supplies for our ongoing clinical trials or any future clinical trials that they may conduct, and we lack the resources to manufacture any product candidates on a commercial scale. In May 2023, we announced that we had entered into a clinical supply agreement with IMP for the Phase I/IIa clinical study. Pursuant to the clinical supply agreement, IMP is responsible for the global clinical supply chain of CMND-100 from manufacture to the various clinical sites. Clinical drug supply is a critical factor for trial success so collaboration with best-in-class clinical drug supply vendor forestalls the possibility of it being a bottleneck to successful drug delivery. Moreover, it can also deliver enormous benefits, including better investigator and patient experiences as well as cost savings in clinical drug supply. See “Item 4.B. Business Overview-Strategic Focus-Phase I/IIa Clinical Study.” We rely, and expect to continue to rely, on third-party manufacturers to produce our product candidates or other product candidates that we may identify for clinical trials, as well as for commercial manufacture if any product candidates receive marketing authorization and approval. Although we generally do not begin a clinical trial unless we believe they have a sufficient supply of a product candidate to complete the trial, any significant delay or discontinuity in the supply of a product candidate, or the raw material components thereof, for an ongoing clinical trial due to the need to replace a third-party manufacturer could considerably delay the clinical development and potential regulatory authorization of our product candidates, which could harm our business and results of operations. We may be unable to identify and appropriately qualify third-party manufacturers or establish agreements with third-party manufacturers or do so on acceptable terms. Even if they are able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

| ● | reliance on the third party for sourcing of raw materials, components, and such other goods as may be required for execution of its manufacturing processes and the oversight by the third party of its suppliers; |

| ● | reliance on the third party for regulatory compliance and quality assurance for the manufacturing activities each performs; |

| ● | the possible breach of the manufacturing agreement by the third party; |

| ● | the possible misappropriation of proprietary information, including trade secrets and know-how; and |

| ● | the possible termination or non-renewal of the agreement by the third