Company: MIRA
Filing Date: 2025-06-17
Form Type: PREM14A
Source: 0001641172-25-015340
Chunk: 41

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-06-17
Form: PREM14A
Chunk 41
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, and any economic countermeasures by the affected countries or others could exacerbate market and economic instability. There can be no assurance that further deterioration in credit and financial markets and confidence in economic conditions will not occur. A severe or prolonged economic downturn could result in a variety of risks to SKNY’s business.

In addition, inflation in the global economy may impact salaries and wages, costs of goods and transportation expenses, among other things may create market and economic instability. SKNY cannot anticipate all of the ways in which the foregoing, and the current economic climate and financial market conditions generally, could adversely impact our business.

Clinical trials for SKNY’s product candidates are expensive, time-consuming, uncertain, and susceptible to change, delay or termination. The results of clinical trials are open to differing interpretations.

Clinical trials are expensive, time consuming and difficult to design and implement. Regulatory agencies may analyze or interpret the results differently than SKNY. Even if the results of SKNY’s clinical trials are favorable, the clinical trials for a number of SKNY’s product candidates are expected to continue for several years and may take significantly longer to complete. In addition, SKNY, the FDA, or other regulatory authorities, including state and local authorities, or an Institutional Review Board (IRB), with respect to a trial at its institution, may suspend, delay or terminate SKNY’s clinical trials at any time, require SKNY to conduct additional clinical trials, require a particular clinical trial to continue for a longer duration than originally planned, require a change to SKNY’s development plans such that it conducts clinical trials for a product candidate in a different order, e.g., in a step-wise fashion rather than running two trials of the same product candidate in parallel, for various reasons, including:

| ● | lack of effectiveness of any product candidate during clinical 
 trials;                                                        |

| 20 |

| ● | discovery                                                                                           
 of serious or unexpected toxicities or side effects experienced by trial participants or            
 other safety issues, such as drug interactions, including those which cause confounding changes     
 to the levels of other concomitant medications;                                                     |
| ● | slower than expected rates of subject recruitment and enrollment                                    
 rates in clinical trials;                                                                           |
| ● | difficulty                                                                                          
 in retaining subjects who have initiated a clinical trial but may withdraw at any time due          
 to adverse side effects from the therapy, insufficient efficacy, fatigue with the clinical          
 trial process or for any other reason;                                                              |
| ● | delays                                                                                              
 or inability in manufacturing or obtaining sufficient quantities of materials for use