60 Degrees Pharmaceuticals, Inc.

Overview

• Specialty pharmaceutical company focused on infectious diseases, developing and commercializing therapies based on biological science and applied research.
• Core asset: Arakoda (tafenoquine) for malaria prevention, approved in the U.S. (2018) and in Australia (Kodatef).
• Pipeline and programs include:
  • Expanded tafenoquine indications (e.g., babesiosis, post‑exposure prophylaxis).
  • Celgosivir and related castanospermine/botanical extracts from the Australian Chestnut Tree (Castanospermum australe), including Castanoboost.
  • Veterinary applications, including canine babesiosis under the Zamvio brand.
• Business model: outsourced manufacturing and use of partnerships and licensing to advance development while managing internal cost and risk.
• Active licensing and collaborations with the U.S. Army, universities, FSURF, Tufts, Yale, and other research institutions.

Corporate History and Structure

• Incorporated in Delaware on June 1, 2022.
• Formed via merger in which 60 Degrees Pharmaceuticals, LLC (DC) merged into 60 Degrees Pharmaceuticals, Inc.; resulting capitalization and cost-basis details documented for the merger.
• Subsidiaries and ownership:
  • 60P Australia Pty Ltd (Sydney) holds sub-licensing rights for several ex‑U.S. territories; the Company owns 97% of 60P Australia.
  • 60P Singapore Pte. Ltd. was dissolved in Q2 2022.
• Reverse stock split activity between 2024–2026, including a 1-for-4 reverse split effected on January 20, 2026; shares began trading on Nasdaq on a split-adjusted basis.
• 2022 Equity Incentive Plan amended multiple times to increase authorized shares; as of March 30, 2026, 115,284 shares remain available for issuance under the plan.

Products and Development Programs

• Arakoda (tafenoquine) — malaria prevention
  • NDA submitted; approvals in the U.S. and Australia.
  • Commercial strategy and pilot marketing efforts underway.
  • Pediatric study plan deferred to December 2030 with an estimated cost of about $2 million; REMS considerations part of post‑marketing planning.
  • Clinical profile includes once‑weekly dosing after a 3‑day loading regimen and activity against liver and blood stages.
• Tafenoquine for babesiosis
  • Phase II and expanded access activities underway, including treatment of patients often co‑infected with Lyme disease.
  • Planned clinical programs:
    • Trial 1: randomized, placebo‑controlled study of ~1 month tafenoquine with standard care; interim analysis expected around September 2026.
    • Trial 2: expanded use study with commercially available Arakoda in a limited number of patients per year.
    • Trial 3: open‑label study assessing fatigue and molecular cure in chronic babesiosis with multi‑month follow‑up.
  • Clinical and research partnerships: Tufts Medical Center, Brigham & Women’s Hospital, Yale, Rhode Island Hospital, and North Carolina State University (veterinary collaboration).
  • License arrangements with Yale and Tufts related to babesiosis indications.
• Celgosivir and related programs
  • Historical focus on dengue, Zika, RSV; Celgosivir licensed from National University of Singapore (NUS) and others.
  • Development paused pending clarity on Castanoboost opportunities; options and licensing activities continue with FSURF and other collaborators.
• Australian Chestnut Extract (Castanoboost)
  • Castanospermine‑derived extract with antiviral, metabolic, and immunomodulatory properties.
  • 75‑day FDA notification filed for a capsule formulation; commercial and regulatory strategies under development, including potential non‑Rx applications.
  • Supply and manufacturing options include FSURF agreements; an option was exercised in February 2026 for exclusive large‑scale purification rights and negotiation of a full license.
• Veterinary indications
  • Canine babesiosis under the Zamvio brand; NC State pilot study completed; pursuing regulatory and market pathways including potential MUMS designation and conditional approvals.

Intellectual Property and Licensing

• Co‑owns U.S. Army patents for tafenoquine use in malaria and holds an exclusive worldwide license to use Army data for tafenoquine in therapeutic applications outside radical cure of symptomatic vivax malaria.
• Licenses with NUS/SHS for Celgosivir and related regimens; royalty obligations include a 1.5% royalty on gross sales or specified minimums under certain agreements.
• License agreements with Tufts Medical Center and Yale University for babesiosis‑related tafenoquine uses; agreements include tiered royalties and sublicensing terms.
• FSURF agreements relate to castanospermine purification and options to license related technology.
• Patent estate includes tafenoquine regimens (malaria), tafenoquine for babesiosis, celgosivir for dengue, and multiple castanospermine/alpha‑glucosidase inhibitor families, with issued and pending patents worldwide.

Manufacturing and Operations

• No owned or operated manufacturing facilities for clinical or commercial quantities; manufacturing is outsourced or provided under license.
• Strategy emphasizes use of external manufacturers to control cost and operational risk.

Regulatory and Compliance

• Engagement with regulatory frameworks in the U.S., EU/UK, and Australia, covering IND/NDA processes, clinical trial approvals, GCP/cGMP requirements, REMS considerations, and post‑marketing surveillance.
• Company considers expedited pathways where applicable (e.g., Fast Track, Priority Review, Tropical Disease PRV).

Commercial and Market Strategy

• Commercial initiatives:
  • Appointed Chief Commercial Officer Kristen Landon in February 2024.
  • Implemented a digital marketing revamp and a virtual/digital sales force pilot.
  • Partnerships to expand patient reach and access, including collaborations with Runway Health and GoodRx.
  • Marketing focus on convenience, broad efficacy, and co‑pay programs to reduce patient out‑of‑pocket costs.
• Market context:
  • U.S. malaria‑prevention prescriptions estimated at approximately 1.1 million annually, with an accessible market for Arakoda estimated at about 330,000 prescriptions.

Financial Highlights and Financing Activities

• Material financing events and net proceeds disclosed:
  • 2024 At‑The‑Market (ATM) offering with WallachBeth Capital: gross proceeds $1,994,583.
  • January 2025 registered direct offering: 51,079 shares; net proceeds approx. $804,346.
  • February 2025 registered direct offering with warrants: 75,176 shares; net proceeds approx. $908,627.
  • July 2025 registered direct offering: 438,332 units plus 219,569 pre‑funded units; net proceeds approx. $4,281,300.
  • 2025 ATM sales agreement with H.C. Wainwright & Co.: net proceeds $1,239,819.
  • 2026 ATM (amended): approx. net proceeds $2,545,297 from 1,055,106 shares sold (Mar 2–Mar 25, 2026).
  • 2025 ATM prospectus supplement increased aggregate offering capacity by $981,000.
• Securities activity includes multiple securities purchase agreements, placement agent warrants, and related terms.
• Stockholder approvals and reverse split resolutions in 2024–2026 affected share counts and trading basis.
• As of March 30, 2026, 115,284 shares remain available under the 2022 Equity Incentive Plan.

People

• Appointed Chief Commercial Officer Kristen Landon in February 2024.
• Ongoing hiring and commercial initiatives to support Arakoda and pipeline programs.

Key Partnerships and Relationships

• U.S. Army: co‑ownership of tafenoquine patents and data license arrangements.
• National University of Singapore (NUS)/SHS: exclusive licenses for celgosivir and related regimens.
• FSURF: castanospermine purification agreements and option exercised for exclusive large‑scale purification rights.
• Tufts Medical Center and Yale University: licenses and collaborative trial activity for babesiosis indications.
• Clinical and research collaborators: Brigham & Women’s Hospital, Tufts, Yale, Rhode Island Hospital, and North Carolina State University (veterinary work).