Company: PTPI
Filing Date: 2025-01-24
Form Type: S-1
Source: 0001410578-25-000047
Chunk: 32

Company: Petros Pharmaceuticals, Inc.
Filing Date: 2025-01-24
Form: S-1
Chunk 32
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There can be no assurance that the proceeds raised in this offering will be sufficient to complete the development, testing, regulatory approvals or commercialization of our platform. The development of new products is inherently expensive, time-consuming, and uncertain, and additional capital may be required to achieve our objectives.

If the proceeds from this offering, together with our existing cash resources, are insufficient to fund the development of our platform, we may need to secure additional financing, which may not be available on acceptable terms, or at all. Failure to obtain adequate funding

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could result in delays or the inability to complete the development and launch of our platform, which could materially and adversely affect our business, financial condition, and prospects. Any difficulties or delays in product engineering, regulatory compliance, sales or marketing could affect Petros’ future results. Petros’ ability to achieve its business objectives is directly dependent on its ability to get its products to market, and any delays or difficulties in engineering, regulatory compliance, sales or marketing could have an adverse impact, including but not limited to the following types of events:

| ● | failure to predict market demand for, or to gain market acceptance of, approved products; |

| ● | failure to comply with applicable regulatory requirements, which could result in costly and disruptive enforcement actions, or otherwise require costly and disruptive corrective actions; |

| ● | delays, unavailability, or undetected defects with respect to our technology; |

| ● | failure to establish and maintain market demand and acceptance for Petros’ products through marketing and sales activities, and any other arrangements to promote these products; |

| ● | failure to establish and maintain agreements with wholesalers, distributors, and group purchasing organizations on commercially reasonable terms; |

| ● | failure to effectively compete with other products on the market; and |

| ● | failure to maintain a continued acceptable product safety and efficacy profile. |

Our technology may be viewed as relatively new or untested, which could result in regulatory delays or disruptions in the pathway to commercialization. One of the most critical factors is alignment with the FDA regarding the SaMD model, SaaS platform, and the underlying technology, including emerging elements like AI, each of which may significantly impact the future of the Petros’ commercial model. Lack of clarity or delays in FDA approval of these technologies could have a significant impact on our ability to scale and execute our business model. Additionally, each licensee using our proprietary technology would need to secure individual FDA approval for their specific product within the SaMD and