Kailera Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and marketable securities totaled $1,037.6 million as of September 30, 2026, providing a runway into mid-2028.
• Research and development (R&D) expenses were $84.7 million for the quarter ended September 30, 2026, compared to $27.0 million in the same period in 2025, an increase of $57.7 million driven by product candidate development, nonclinical, clinical, contract manufacturing costs, and personnel.
• General and administrative (G&A) expenses were $21.7 million for the quarter ended September 30, 2026, compared to $13.1 million in the same period in 2025, an increase of $8.6 million driven by personnel and professional service costs.
• Net loss was $95.7 million for the quarter ended September 30, 2026, compared to a net loss of $39.6 million in the same period in 2025.
• For the nine months ended September 30, 2026, R&D expenses were $256.6 million and G&A expenses were $55.8 million, compared to $56.6 million and $34.6 million, respectively, in the same period in 2025.
• Net loss for the nine months ended September 30, 2026, was $285.8 million, compared to $86.6 million in the same period in 2025.
• Interest income was $10.6 million for the quarter ended September 30, 2026, compared to $2.3 million in the same period in 2025.

Guidance and Future Outlook:

• Ribupatide oral global Phase 3 program is expected to begin in the first half of 2027 following the completion of the End-of-Phase 2 meeting with the FDA.
• Ribupatide injection Phase 2b trial data is expected in mid-2027, and the KaiNETIC global Phase 3 program data is expected in mid-2028.
• Safiglipron (KAI-7535) global Phase 2 trial data is now anticipated in mid-2027.
• KAI-4729 Phase 1 single-dose injection site/ethnic bridging trial is on track to initiate by the end of 2026, with data anticipated in 2027.
• Management indicated the balance sheet supports multiple value-creating inflection points into mid-2028.

Business Segments and Product Lines:

• Ribupatide Injection (KAI-9531): The KaiNETIC global Phase 3 program is fully enrolled, encompassing three trials with approximately 5,000 participants evaluating once-weekly doses up to 10 mg over 76 weeks. The Phase 2b high-dose trial is fully enrolled with approximately 260 U.S. participants evaluating doses of 10 mg, 13 mg, 16 mg, and 20 mg over 48 weeks.
• Ribupatide Oral (KAI-9531-T): Following the End-of-Phase 2 meeting, the global Phase 3 program will include two trials evaluating once-daily doses up to 25 mg over 60 weeks in adults with obesity or overweight, with and without type 2 diabetes.
• Safiglipron (KAI-7535): The global Phase 2 trial is fully enrolled with approximately 300 participants in the U.S. and Australia, evaluating a wide range of doses over 44 weeks with a starting dose of 15 mg to optimize the clinical profile for tolerability and weight loss.
• KAI-4729: The Investigational New Drug (IND) application is active with the U.S. FDA for this GLP-1/GIP/Glucagon receptor tri-agonist.

Market and Competitive Landscape:

• Kailera is advancing a diversified GLP-1-based pipeline of clinical-stage therapeutic candidates for the treatment of obesity, including single-, dual-, and triple-agonist mechanisms and both oral and injectable formulations.
• The company's approach aims to improve upon currently available treatments by maximizing weight loss, improving tolerability, and addressing critical needs in the therapeutic landscape.
• Ribupatide injection is positioned as a lead product candidate with the potential for the greatest weight loss.

Risks and Challenges:

• Forward-looking statements involve substantial risks and uncertainties, including uncertainties inherent in clinical development, regulatory review, manufacturing, competition, and market opportunities.
• Actual results could differ materially from expectations due to reliance on third parties, estimates of capital requirements, and the need for additional financing.
• Specific risks include the timing, design, and outcome of research and development activities, as well as the potential for forward-looking statements to prove inaccurate.

Management Commentary and Tone:

• Ron Renaud, President and CEO, stated that strong execution this quarter reflects the company's commitment to bringing new medicines to people living with obesity.
• Management expressed confidence that all four product candidates are on track to deliver important clinical milestones in 2027, including the initiation of the ribupatide oral Phase 3 trial and the data readout from the ribupatide injection Phase 2b trial.
• The CEO highlighted the ribupatide franchise's category-leading potential and the company's energized outlook for delivering value-creating inflection points.

Other Key Points:

• Kailera expects to participate in the Stifel 2026 Healthcare Conference, ObesityWeek 2026, Jefferies Global Healthcare Conference in London, 9th Annual Evercore Healthcare Conference, and the 45th Annual J.P. Morgan Healthcare Conference.
• The company completed a significant capital event between December 31, 2025, and September 30, 2026, evidenced by the conversion of Series A and Series B convertible preferred stock to zero and a substantial increase in additional paid-in capital from $11.9 million to $1,689.4 million.
• Accumulated deficit increased from $(368.7) million as of December 31, 2025, to $(654.5) million as of September 30, 2026.
• Total assets increased to $1,082.2 million as of September 30, 2026, from $692.3 million as of December 31, 2025.