4D Molecular Therapeutics — Q3 2026 Earnings Summary

Financial Performance:

• Collaboration and license revenue was $4.1 million for Q3 2026, compared to $0.1 million in Q3 2025, driven by clinical trial cost sharing and reimbursement from Otsuka.
• Research and development expenses were $69.8 million for Q3 2026, an increase from $49.4 million in Q3 2025, primarily due to the execution of 4D-150 Phase 3 clinical trials in wet AMD.
• General and administrative expenses were $15.6 million for Q3 2026, up from $11.8 million in Q3 2025.
• Net loss was $78.1 million for Q3 2026, compared to a net loss of $56.9 million in Q3 2025.
• Cash, cash equivalents, and marketable securities totaled $375.0 million as of September 30, 2026, down from $514.0 million as of December 31, 2025.
• The company estimates its current cash position and expected payments under the collaboration agreement with Otsuka will fund operations into the second half of 2028.
• Total assets were $428.7 million as of September 30, 2026, compared to $566.7 million as of December 31, 2025.
• Total liabilities were $90.8 million as of September 30, 2026, compared to $61.0 million as of December 31, 2025.
• Accumulated deficit increased to $(936.1) million as of September 30, 2026, from $(716.3) million as of December 31, 2025.
• Net loss per share (basic and diluted) was $(1.08) for Q3 2026, compared to $(1.01) in Q3 2025.

Guidance and Future Outlook:

• Topline data for the 4FRONT-1 Phase 3 trial in wet AMD is expected in Q2 2027.
• Topline data for the 4FRONT-2 Phase 3 trial in wet AMD is expected in H2 2027.
• Management anticipates 2027 will be a transformative year for the Company following expected topline readouts from both 4FRONT Phase 3 trials.
• An update on the AEROW Phase 1/2 clinical trial for 4D-710 in Cystic Fibrosis is expected at year-end.

Business Segments and Product Lines:

• Completed enrollment and randomization of the 4FRONT-2 Global Phase 3 clinical trial for 4D-150 in wet AMD (N=531), with randomization completed in August 2026.
• Initiated the 4SIGHT Global Phase 3 clinical trial for 4D-150 in Diabetic Macular Edema (DME) (N=514), advancing the candidate into a second multi-billion-dollar retinal disease market.
• Presented 2-year data from the PRISM trial (wet AMD) and SPECTRA Part 1 trial (DME), highlighting durable clinical activity, favorable safety profiles, and treatment burden reduction.
• The 4SIGHT trial is a global, multicenter, randomized, double-masked, aflibercept 2 mg (Q8W) comparator-controlled trial with a primary endpoint of non-inferiority in mean change from baseline in best corrected visual acuity (BCVA) at Week 52.
• The company maintains an active IND for 4D-175 in Geographic Atrophy and is evaluating opportunities to advance the program into the clinic.
• Strengthened the regulatory and quality teams by hiring Eric Floyd, PhD, MBA, as Chief Regulatory & Quality Officer.

Market and Competitive Landscape:

• 4D-150 is positioned as a potential backbone therapy for continuous control of VEGF-driven retinal diseases, aiming to transform treatment paradigms by providing multi-year sustained delivery with a single intravitreal injection.
• The company identifies significant unmet need in wet AMD and DME markets.
• During an Investor Day in New York City on October 21, 2026, the company provided insights into the current treatment landscape and the commercial potential of 4D-150 to improve patient outcomes.

Risks and Challenges:

• All product candidates are in clinical or preclinical development and have not yet been approved for marketing by the U.S. FDA or any other regulatory authority.
• Forward-looking statements regarding therapeutic potential, clinical development plans, and financial performance are subject to risks and uncertainties that may cause actual results to differ materially.
• Specific risks and uncertainties are detailed in the "Risk Factors" section of the company's most recent Quarterly Report on Form 10-Q.

Management Commentary and Tone:

• David Kirn, MD, Co-founder, President, and CEO, stated the company is well-positioned heading into 2027 as a transformative year following expected topline readouts.
• Management highlighted the completion of randomization in the second pivotal Phase 3 trial in wet AMD and the initiation of the global Phase 3 program in DME as key progress indicators.
• The tone reflects confidence in the durable clinical activity and favorable safety profile of 4D-150 observed in Phase 1/2 data.

Other Key Points:

• The company hosts an Investor Day in New York City on October 21, 2026, to discuss the target product profile and commercial potential of 4D-150.
• The company has a collaboration agreement with Otsuka Pharmaceutical Co., Ltd. (Otsuka) providing clinical trial cost sharing and reimbursement.
• 4D-150 is designed to substantially reduce the treatment burden associated with current bolus injections for blinding VEGF-driven retinal diseases.
• 4D-710 is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery.