NanoNeurosciences is proud to announce the completion of its Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for its lead candidate, NNS-01, a landmark achievement that marks the beginning of the Company's transition into clinical development. The meeting resulted in strong regulatory alignment on our overall development strategy and established a clear FDA pathway toward IND submission and first-in-human clinical trials. Importantly, the FDA's feedback was greatly supportive of our proposed preclinical and Phase 1 clinical development programs.

The FDA expressed strong support for our proposed preclinical and Phase 1 clinical development program, confirming that our strategy is appropriate for advancing NNS-01. Their enthusiastic feedback on the innovative, first-in-class nature of our supramolecular nanomedicine platform marks a significant de-risking milestone for NanoNeurosciences, strengthens our regulatory position, and reinforces our confidence in moving NNS-01 toward the clinic. As we enter this next phase, we are closer to translating years of scientific progress into a potentially transformative therapy for patients with glaucoma and ocular hypertension.

The Pre-IND meeting validates the scientific rigor, regulatory strategy, and execution capabilities of NanoNeurosciences. Achieving this milestone reflects years of innovation, strategic investment, and disciplined execution.

With a defined FDA pathway, the Company is entering a transformational phase
that enhances its technology platform, strengthens its competitive position, and opens opportunities for partnerships, licensing, and financing. As NNS-01 advances toward clinical evaluation, NanoNeurosciences is transitioning from a preclinical biotechnology company to a clinical-stage organization with a differentiated therapeutic platform.

For investors, this milestone is more than regulatory progress; it marks a significant value inflection point. Clinical-stage companies with clear regulatory strategies are well positioned to attract institutional interest, strategic collaborations, and new investment. The FDA Pre-IND meeting outcome demonstrates NanoNeurosciences’ commitment to scientific excellence, regulatory discipline, and a clear commercialization vision. With an established FDA pathway and focused strategy toward IND submission and clinical trials, the Company is well positioned to accelerate growth, create long-term value, and advance therapies that may transform ophthalmic disease treatment.

info@nanoneurosciences.com
NanoNeurosciences Research & Developement Laboratory:
UF Innovate at Sid Martin, 12085 Research Dr, Lab # 130, Alachua, FL 32615, USA
www.nanoneurosciences.com