Slide 1: Tafenoquine for Severe Babesiosis Study Interim Data Readout Webinar
Tafenoquine for Severe Babesiosis Study Interim Data Readout Webinar October 6, 2026 Today's discussion • Clinical context and current standard of care • Published evidence supporting tafenoquine + atovaquone • Hospital study interim analysis and DSMB feedback • Next steps and regulatory path • Near
Slide 2: Disclaimer and Forward-Looking Statements
Disclaimer and Forward-Looking Statements DISCLAIMER. The information contained herein has been prepared to assist prospective investors in making their own evaluation of 60 Degrees Pharmaceuticals, Inc. (the "Company") and does not purport to be all- inclusive or to contain all of the information a
Slide 3: Ticks Transmit a Widening Set of Serious Diseases in the U.S.
Ticks Transmit a Widening Set of Serious Diseases in the U.S. Record tick-bite emergency room visits in 2026 underscore the rising need for targeted therapies. ER visits for tick bites RECORD LEVELS THIS YEAR (113,000+) One bite can transmit More bites + more clinical encounters multiple pathogens E
Slide 4: Phases and Development Stages
PHASES AND DEVELOPMENT STAGES PRODUCT NON-CLINICAL IND ENABLING PHASE 1 PHASE IIA PHASE IIB/III REGULATORY REVIEW COMMERCIALLY AVAILABLE COMMERCIALLY SUSTAINABLE ARAKODA® (tafenoquine): US MARKET ZAMVIO (tafenoquine): TICK-BORNE DISEASE – VETERINARY INDICATIONS Tafenoquine (ARAKODA regimen): TREATME
Slide 5: Babesiosis
BABESIOSIS From tick bite to red-blood-cell infection RBC parasite + Tick-borne + Transfusion risk Transmission pathways + symptoms that drive clinical urgency Transmission cycle sympto to highlig Often asymptomatic — but symptomatic cases can resemble severe flu ‘meal, introduces Merozoite transmis
Slide 6: NEJM 2000: Atovaquone + Azithromycin for Babesiosis
NEJM 2000: Atovaquone + Azithromycin for Babesiosis Prospective, randomized trial demonstrating comparable efficacy with fewer adverse events Atovaquone + Azithromycin Clindamycin + Quinine (n = 40) (n = 18) Atovaquone Clindamycin oY 750 mg every 12 hours a 600 mg every 8 hours Azithromycin vs Quini
Slide 7: Mortality in immunocompetent patients
≤35% up to 1.4% mortality in immunocompetent patients 6
Slide 8: Response definition and primary analysis
Response = no retreatment for at least 12 weeks after treatment cessation; primary analysis retains case 20 and excludes courses with unknown post-treatment follow-up. ©2026 60 Degrees Pharmaceuticals, Inc. CONFIDENTIAL All rights reserved. 7 7
Slide 9: Tafenoquine + Atovaquone: Proof of Combination Activity in Mouse Model
©2026 60 Degrees Pharmaceuticals, Inc. CONFIDENTIAL All rights reserved. 8 Tafenoquine + Atovaquone: Proof of Combination Activity in Mouse Model Vydyam et al. SCID-mouse B. microti model Atovaquone RELAPSE Parasitemia initially suppressed, followed by recrudescence after treatment. Tafenoquine PART
Slide 10: First Published Tafenoquine Case Series in Relapsing Babesiosis
First Published Tafenoquine Case Series in Relapsing Babesiosis Krause et al., Clinical Infectious Diseases, 2024 CASE 2 Representative successful case Smear parasitemia, PCR status and treatment exposure over time Case 2 illustrates clearance after prolonged combination therapy WHAT THE CASE SERIES
Slide 11: Treatment order and duration by case
Each row preserves treatment order. Block width reflects duration on a logarithmic scale. 10
Slide 12: ARAKODA approval and safety profile
11 adult age group indicated 11 11 11 2018 US FDA approval 2019 commercially available Indicated for prophylaxis of malaria in adults 8 studies >1,100 patients 52 weeks AE rate comparable to placebo; G6PD screening required. For full Arakoda prescribing information and important safety information,
Slide 13: ARAKODA for Babesiosis: Clinical Development Plan
ARAKODA® for Babesiosis: Clinical Development Plan Three active clinical programs focused on severe and relapsing disease Randomized Placebo-Controlled Study Hospitalized babesiosis patients 30 enrolled as of 10/1/2026 Tafenoquine + SOC vs placebo + SOC Primary endpoint: TTSCR Follow-up through earl
Slide 14: Interim Analysis Scenarios and DSMB Feedback
Interim Analysis Scenarios and DSMB Feedback Scenario DSMB Interim Analysis Recommendation Enroll More Patients in 2027 P-Value and Conditional Power at Interim Analysis Hospital Study Ends With Positive Outcome 1 2 3 4 Endpoint met, terminate study Enroll more subjects (4-19) Complete study as orig
Slide 15: Next Steps
Next Steps Complete the current 30-patient dataset and move to unblinding 30 PATIENTS ENROLLED Enrolment status 30 patients enrolled as of 10/1/2026. 3 ADDITIONAL PATIENTS Waiting adds a full tick season Enrolling the final 3 subjects would defer complete data output until Fall 2027. ≈ MINIMAL IMPAC
Slide 16: Two Regulatory Paths to a Babesiosis sNDA
Two Regulatory Paths to a Babesiosis sNDA Same evidence base — pathway depends on the hospital-study outcome COMMON EVIDENCE BASE Published refractory cases • Expanded-access cures • Non-clinical additivity • Marketed-drug safety base DEFAULT PATH | Accelerated Approval If hospital study is not inde
Slide 17: Milestones Through Q1 2028
Milestones Through Q1 2028 A staged path from clinical readout to potential launch OTHER ANTICIPATED MILESTONES New collaborations • market updates • research updates CLINICAL SIGNAL Q4 2026 REGULATORY ALIGNMENT Q1 2027 FILING Q2 2027 REVIEW Q4 2027 LAUNCH Q1 2028 10/6/26 Hospital study interim anal
Slide 18: Webinar Scientific Experts
Webinar Scientific Experts Two leading babesiosis researchers bringing clinical and translational perspective Peter J. Krause, MD Senior Research Scientist · Yale School of Public Health & Yale School of Medicine International authority on human babesiosis and vector-borne disease Led the first rand