NICHE BIOPHARMACEUTICALS LLC

• Niche Biopharmaceuticals has invented a Dual-Acting Anti-Infective Therapeutic (DAIT) with activity in the ug/mL range against over 40 different bacterial organisms.
  • DAIT is also potent against envelope viruses such as SARS-CoV-2 and influenza.
  • Bacteria have been shown to be unable to develop resistance to this class of antibiotics over 52 weeks of culture at 50% of the minimum bactericidal concentration (MBC).
  • DAIT are anti-inflammatory.
• US Patents 11365176 and 11572342 are both allowed.
• DAIT (code named NB2) is a new chemical entity per FDA regulations, meaning that it has never been synthesized until Niche was able to create the molecule.
• NicheBio has focused its initial efforts on two market opportunities Clostridioides difficile (C. diff., CDI) & Atopic dermatitis.
• These initial two markets (C. diff. & Atopic dermatitis) are on the order of $5 billion per year or greater in the United States.
• Future markets opportunities would cover the other potential many indications.
• We plan to conduct a pre-IND meeting with the FDA Infectious disease division Q2 2023 to define the requirements for activation of the IND and what will be required through to registration.
• We are looking to raise $5 million to take us through the phase 1 clinical trial.

Address and contact information:

Niche Biopharmaceuticals LLC
22345 Bracketts Road
Shorewood, MN 55331 USA

Founder and Chairman: Dayton T. Reardan, Ph.D., RAC
Contact email: Info@NicheBiopharma.com

Niche Biopharmaceuticals LLC is an early stage Limited Liability Company registered in the state of Delaware doing business in Minnesota.