Relay Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for the three months ended September 30, 2026, was $0, compared to $0 in the same period in 2025.
• Total revenue for the nine months ended September 30, 2026, was $3.35 million, a decrease from $8.36 million in the same period in 2025.
• Research and development expenses were $77.1 million for Q3 2026, an increase of $8.8 million (12.9%) compared to $68.3 million in Q3 2025.
• General and administrative expenses were $13.1 million for Q3 2026, an increase of $1.0 million (8.3%) compared to $12.1 million in Q3 2025.
• Net loss was $81.7 million for Q3 2026 ($0.37 per share), compared to a net loss of $74.1 million ($0.43 per share) in Q3 2025.
• Net loss for the nine months ended September 30, 2026, was $238.7 million ($1.19 per share), compared to $221.6 million ($1.30 per share) in the prior year period.
• Cash, cash equivalents, and investments totaled $848.6 million as of September 30, 2026, down from $910.9 million as of June 30, 2026, and up from $554.5 million as of December 31, 2025.
• The company expects its current cash position to fund operating expenses and capital requirements into 2029.
• Total assets were $901.7 million as of September 30, 2026, compared to $621.3 million as of December 31, 2025.
• Total stockholders' equity was $819.0 million as of September 30, 2026, compared to $567.1 million as of December 31, 2025.

Guidance and Future Outlook:

• The Phase 3 ReDiscover-2 trial in second-line breast cancer is estimated to complete enrollment in mid-2027, approximately one year faster than recent benchmarks.
• A regulatory update to confirm the design for a planned Phase 3 trial in first-line endocrine-sensitive breast cancer is expected by year-end 2026.
• Initiation of the Phase 3 trial in first-line breast cancer is anticipated in early 2027.
• Data updates for the Phase 1/2 ReDiscover trial triplet combination are expected in 2027.
• The company plans to host a corporate conference call on December 14, 2026, following the ASH presentation to review data and provide a regulatory update.

Business Segments and Product Lines:

• Zovegalisib (PI3Kα inhibitor): Currently in a Phase 3 trial (ReDiscover-2) for HR+/HER2- metastatic breast cancer and a Phase 1/2 study (ReInspire) for PIK3CA-driven vascular anomalies.
• Vascular Anomalies: Enrollment continues for expansion cohorts in adults and adolescents (ages 12+) and dose escalation for pediatric patients (ages 6-11). Updated data from the ReInspire study will be presented at the 68th ASH Annual Meeting.
• TIE2 Inhibitor: A new research program for a mutant-selective TIE2 inhibitor is in late-stage preclinical development, targeting venous malformations.
• Lirafugratinib (LYRFIGTU): Received full FDA approval for cholangiocarcinoma with FGFR2 fusion or rearrangement; licensed to Elevar Therapeutics in December 2024. This is the first approved medicine from Relay's Dynamo platform.
• Pipeline: Includes programs for NRAS-driven solid tumors and Fabry disease.

Market and Competitive Landscape:

• Zovegalisib targets approximately 140,000 patients with HR+/HER2- breast cancer with a PI3Kα mutation and an estimated 170,000 patients with PI3Kα-driven vascular anomalies annually in the U.S.
• For TIE2-mutated venous malformations, an estimated 50,000-60,000 people in the U.S. are affected, with no currently approved systemic therapies.
• The company highlights that non-selective approaches to TIE2 inhibition can lead to severe ocular toxicities due to off-target inhibition of wild-type TIE2.
• Management noted encouragement from Pfizer's FourLight-1 trial data, which they believe demonstrated the potential advantage of a CDK4-selective approach.

Risks and Challenges:

• Forward-looking statements are subject to risks including global economic uncertainty, geopolitical instability, public health epidemics, and regulatory developments.
• Risks include delays or pauses in clinical trials, preliminary results not being predictive of final outcomes, and the inability to demonstrate safety and efficacy.
• Challenges include the timing and outcome of interactions with regulatory authorities and obtaining, maintaining, and protecting intellectual property.
• Non-recurring costs related to the termination of the operating lease at One Kendall Square contributed to increased R&D and G&A expenses.

Management Commentary and Tone:

• CEO Sanjiv Patel expressed pleasure with the enrollment pace of the ReDiscover-2 trial and excitement regarding the upcoming ASH data presentation.
• Management highlighted the strategic value of the CDK4-selective approach observed in Pfizer's trial.
• The tone is confident regarding the company's mission to bring life-changing therapies to patients across multiple PI3Kα opportunities.

Other Key Points:

• Executive Appointment: Shannon Campbell joined as Head of Commercial, bringing over 30 years of experience, most recently as Executive Vice President and Chief Commercial Officer at Merus. She will lead commercial preparations for zovegalisib in breast cancer and vascular anomalies.
• Strategic Partnership: The FDA approval of lirafugratinib resulted from a global licensing agreement with Elevar Therapeutics entered into in December 2024.
• Clinical Trial Efficiency: The ReDiscover-2 trial enrollment is projected to be completed approximately one year faster than recent industry benchmarks.
• Conference Presentation: An oral presentation on updated ReInspire data will occur on December 14, 2026, at the 68th ASH Annual Meeting (Abstract Number 878).