Company: MIRA
Filing Date: 2025-08-08
Form Type: DEFM14A
Source: 0001641172-25-022816
Chunk: 199

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-08-08
Form: DEFM14A
Chunk 199
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 success rate at each of the four phases of development: Phase I, II, III, and regulatory filing. Having phase-by-phase data in hand, we then compared groups of diseases, drug modalities, and other attributes to generate the most comprehensive analysis yet of biopharmaceutical R&D success.”

1 Clinical Development Success rates and Contributing factors 2011 – 2020 / BIO, February 2021

| Moore Financial Consulting |

| SKNY Pharmaceuticals, Inc. | April 2025    |
| Valuation                  | Page 21 of 25 |

One of the results of the BIO research is the following table containing the success rates per disease area:

As can be seen, the success rates of clinical trials differ according to the area of disease and according to the phase. The average success rates are represented by “All Indication” in which the probability of success of Phase I is 52% and those of Phase II and Phase III are 28.9% and 57.8% respectively. For the Company’s indications development, we used the Neurology success rates from the above table. Also, the success rate in IND application is around 90% 1.

The following table contains the success rates per application:

1Lapteva L, Pariser AR. Investigational New Drug applications: a 1-year pilot study on rates and reasons for clinical hold. J Investig Med. 2016 Feb;64(2):376-82. doi: 10.1136/jim-2015-000010. PMID: 26911627.

| Moore Financial Consulting |

| SKNY Pharmaceuticals, Inc. | April 2025    |
| Valuation                  | Page 22 of 25 |

Cash Flows

Following are the cash flows based on the assumptions described above, prior to the implementation of the clinical trials success rates:

According to the rNPV method used in this valuation, all the revenues and expenses in the model are multiplied by the probability of success; for instance, the SKNY-1(Nicotine Dependence) R&D expenses until Phase I are to be multiplied by the probability of success of the SKNY-1(Nicotine Dependence) IND (90%). Another example, Royalties revenue from the SKNY-1(Nicotine Dependence) must be multiplied by the product of the probability of success of IND ,Phase I, Phase II, Phase III and NDA (90.00% * 47.70% * 26.80