Hydreight closes acquisition of 800,000 Insu units

Executive Summary

• Hydreight Technologies Inc. has closed a $300,000 strategic investment in Insu Therapeutics Inc., acquiring 800,000 units to gain early exposure to Insu's novel buccal delivery platform for peptide therapeutics.
• The transaction provides Hydreight with exclusive U.S. distribution rights for Insu's peptide technologies, contingent on successful development and regulatory approvals, aligning with Hydreight's national pharmacy and telehealth infrastructure.
• Insu Therapeutics is advancing its proprietary buccal delivery platform for FDA-approved peptides (specifically insulin and semaglutide/Ozempic) via the 505(b)(2) regulatory pathway, targeting an FDA submission for clinical study approval in early 2027.

Key Details

• Transaction Structure: Hydreight acquired 800,000 units of Insu Therapeutics at a price of $0.375 per unit.
• Total Consideration: $300,000, paid as follows:
  • $150,000 in cash (50%).
  • 37,037 common shares of Hydreight Technologies (50%), valued at a deemed price of $4.05 per share.
• Unit Composition: Each unit consists of one common share of Insu and one common share purchase warrant.
• Warrant Terms: Each warrant is exercisable to acquire one Insu share at an exercise price of $1.00 for a period of two years from the date of issuance.
• Strategic Rights: Hydreight secured exclusive U.S. rights to distribute peptide therapeutics utilizing Insu's buccal delivery technology, subject to successful development and regulatory approvals.
• Insu Therapeutics Development Status:
  • Completed animal study program for insulin.
  • Advancing similar program for semaglutide (Ozempic).
  • Established a scalable manufacturing partnership with a world-class CDMO for GMP-certified production.
  • Targeting completion of the manufacturing program within 12 months.
  • Planned FDA submission for clinical study approval for early 2027.
• Regulatory Context: The investment relies on exemptions under Multilateral Instrument 61-101 (Sections 5.5(b) and 5.7(a)) as the transaction value did not exceed 25% of Hydreight's market capitalization.

Notable Quotes

• Shane Madden, CEO of Hydreight: "Hydreight's focus remains on building one of the largest compliant digital health care infrastructure platforms in the United States... This investment allows us to explore a potentially important innovation in peptide delivery while maintaining disciplined capital allocation and focus on scaling our core platform."
• Dr. Anubhav Pratap-Singh, Co-founder of Insu Therapeutics: "Our buccal delivery platform is designed to enable peptide medicines to be absorbed through the oral mucosa, bypassing the gastrointestinal tract. By leveraging the FDA's 505(b)(2) pathway and focusing on already-approved peptide therapeutics, we aim to accelerate development timelines while exploring more convenient delivery options for patients."