Tyra Biosciences — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and marketable securities totaled $700.5 million as of September 30, 2026, up from $255.0 million (calculated from $77,387k cash + $178,616k marketable securities) as of December 31, 2025.
• Research and development expenses for the three months ended September 30, 2026, were $43.1 million, an increase from $25.5 million in the same period in 2025.
• General and administrative expenses for the three months ended September 30, 2026, were $11.7 million, an increase from $7.5 million in the same period in 2025.
• Net loss for the third quarter of 2026 was $51.1 million, compared to a net loss of $29.9 million in the third quarter of 2025.
• Total operating expenses for the nine months ended September 30, 2026, were $145.9 million, compared to $96.2 million for the same period in 2025.
• Net loss for the nine months ended September 30, 2026, was $136.0 million, compared to $86.1 million for the same period in 2025.
• Net loss per share (basic and diluted) for the three months ended September 30, 2026, was $0.74, compared to $0.50 in the same period in 2025.
• Weighted-average shares used to compute net loss per share for the three months ended September 30, 2026, were 69.1 million, compared to 59.7 million in the same period in 2025.
• Interest and other income, net, for the three months ended September 30, 2026, was $3.8 million, compared to $3.1 million in the same period in 2025.

Guidance and Future Outlook:

• The company expects its current financial resources to fund planned operations through 2030.
• Initiation of the Phase 3 adjuvant study for IR NMIBC is expected in 2027, subject to regulatory feedback.
• Additional Phase 2 ablative study results for IR NMIBC are anticipated in 2027.
• Initial Phase 2 results for LG-UTUC are expected in 2027.
• Initial Phase 2 results from the safety sentinel cohort for ACH are expected in 2027.
• The company is advancing preparations for registrational development and regulatory engagement regarding the design of the Phase 3 adjuvant study.

Business Segments and Product Lines:

• Dabogratinib (Lead Candidate): An oral, FGFR3-selective inhibitor currently in Phase 2 development for LG-UTUC, low-grade IR NMIBC, and achondroplasia (ACH).
• SURF302 (IR NMIBC): Initial results reported in September 2026 showed a 79% overall response rate (ORR) and 64% complete response (CR) rate at 60 mg QD among participants with single and multiple marker lesions (n=14). Among participants with a single marker lesion (n=8), the 60 mg QD dose demonstrated a 100% ORR and 75% CR rate.
• SURF302 Safety: Initial safety and tolerability results were favorable across both dose cohorts (n=44), with no clinically significant hyperphosphatemia, nail toxicity, or ocular toxicity observed and no Grade 3 treatment-related adverse events at 60 mg QD. Enrollment in the 60 mg QD cohort is complete, and a 70 mg QD cohort is currently enrolling.
• SURF303 (LG-UTUC): The first participant treated achieved a complete response at the 3-month assessment with 60 mg QD, with no observed treatment-emergent adverse events as of the August 31, 2026 data cutoff. Enrollment continues.
• BEACH301 (ACH): The study has advanced through five dose levels in the safety sentinel cohort. A sixth dose level (0.875 mg/kg) was authorized for the safety sentinel cohort due to favorable safety data. Initial results representing approximately 25 children are expected in 2027.
• Pipeline Expansion: The company is developing TYRA-430 (FGFR4/3-biased inhibitor) in the SURF431 study for advanced hepatocellular carcinoma and TYRA-200 (FGFR1/2/3 inhibitor) in the SURF201 study for metastatic intrahepatic cholangiocarcinoma.
• Regulatory Designations: The FDA has granted Orphan Drug Designation and Rare Pediatric Disease Designation to dabogratinib for the treatment of achondroplasia.

Market and Competitive Landscape:

• Dabogratinib is positioned as a potential first-in-class, orally available, FGFR3-selective inhibitor.
• The company believes dabogratinib has the potential to be the first oral FGFR3-selective inhibitor in intermediate-risk non-muscle invasive bladder cancer (IR NMIBC).
• The company states it has studied dabogratinib in more than 200 individuals to date across multiple clinical and healthy volunteer studies.

Risks and Challenges:

• Clinical trial results, including initial or interim results, are not necessarily indicative of final results and may change as patient enrollment continues or follow-up data becomes available.
• There is a risk that unconfirmed responses may not ultimately result in confirmed responses after follow-up evaluations.
• Proof-of-concept results may fail to result in successful subsequent development of oral dabogratinib.
• Later developments with the FDA may be inconsistent with prior feedback.
• The company is early in its development efforts, and its novel SNÅP platform approach is unproven and may never lead to successful product candidates or approved products.
• Potential delays in trial commencement, recruitment, data readouts, and completion of preclinical studies and clinical trials.
• Dependence on third parties for manufacturing, research, and preclinical testing.
• Risk of expending limited resources on a particular product candidate or indication that fails to capitalize on greater potential.
• Potential for unexpected adverse side effects or inadequate efficacy limiting development or regulatory approval.
• Risks related to geopolitical instability, war, inflation, and interest rate changes.

Management Commentary and Tone:

• CEO Todd Harris, PhD, described 2026 as a "defining year" and expressed conviction that dabogratinib has the potential to fundamentally change the treatment paradigm for patients with FGFR3-driven diseases.
• Management highlighted a "strengthened balance sheet" following the $400 million financing, stating the company is entering its next phase of growth from a position of strength.
• The company believes the opportunity for a highly selective, oral FGFR3 inhibitor has "never been clearer" as it prepares for regulatory engagement and Phase 3 development.
• Management aims to break the cycle of repeated procedures and surveillance for patients by offering a differentiated, first-in-class oral product candidate.

Other Key Points:

• Completed a $400 million underwritten public offering of common stock and pre-funded warrants in September 2026, led by RA Capital Management with participation from new and existing institutional investors.
• The financing provides gross proceeds of approximately $400 million before underwriting discounts, commissions, and offering expenses.
• The company's in-house precision medicine discovery engine, SN&ArING;P, continues to advance, enabling rapid and precise drug design.
• Total assets increased to $727.5 million as of September 30, 2026, from $282.6 million as of December 31, 2025.
• Total stockholders' equity increased to $692.8 million as of September 30, 2026, from $259.2 million as of December 31, 2025.