• 4DMT to receive $85 million upfront cash payment and expect to receive at least $50 million of cost sharing from Otsuka over the next three years for development activities supporting global registration 
• Up to $336 million in potential regulatory and commercial milestones and tiered double-digit royalties depending on net sales in Otsuka’s territories
• Proceeds and cost sharing expected to support global Phase 3 clinical trial in DME and pre-commercial activities

4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today announced a strategic partnership with Otsuka Pharmaceutical Co., Ltd. (Otsuka) to develop and commercialize 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) in the greater Asia-Pacific (APAC) region including Japan.

The strategic partnership combines 4DMT’s expertise in AAV genetic medicine, development in retina and manufacturing with Otsuka’s strong development expertise, regulatory experience and commercial infrastructure across APAC markets. Together, the companies aim to receive 4D-150 marketing approval and commercialization in major markets globally. 4D-150 is a potentially transformative backbone therapy providing durable benefit in retinal vascular diseases such as wet AMD and DME, which are among the leading causes of blindness in the world.

Under the terms of the agreement, 4DMT will grant Otsuka exclusive rights to develop and commercialize 4D-150 for retinal vascular diseases, including wet AMD and DME, in Japan, China, Australia and other Asia-Pacific markets. Otsuka will lead all regulatory and commercialization activities in its licensed territories. 4DMT will continue to lead all Phase 3 clinical activities globally, including within the APAC region. APAC clinical sites in 4FRONT-2, the global Phase 3 study in wet AMD, are expected to open by end of year, with Japan sites expected to open in January 2026.

4DMT will receive an upfront cash payment of $85 million and expected cost sharing of at least $50 million over the next three years for global development activities. In addition, the Company is eligible for up to $336 million in potential regulatory and commercial milestone payments and tiered double-digit royalties depending on net sales in Otsuka’s territories. 4DMT retains full development and commercialization rights for 4D-150 outside the APAC region, including the U.S., Latin America and Europe.

“We are thrilled to announce this strategic partnership with Otsuka, a leading global pharmaceutical company with a strong presence in the APAC region, reflecting our shared long-term commitment to improving outcomes for patients with retinal vascular diseases,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “This partnership is a key pillar of our global strategy, with 4DMT continuing to lead Phase 3 clinical trial and manufacturing activities globally, in addition to pre-commercial and commercial activities outside the APAC region.”

“APAC represents a large and underserved retina market, with a high prevalence of wet AMD and DME. Navigating the region’s regulatory and patient-access complexities requires a strong local partner, and we expect Otsuka’s deep presence and expertise to accelerate both development of and access to 4D-150,” said Chris Simms, Chief Commercial Officer of 4DMT. “Partnering with Otsuka extends the global reach of 4D-150 and ensures that patients in regions with limited access to innovative therapies may ultimately benefit from its potential to deliver durable treatment burden reductions and vision preservation.”

“Otsuka has created new value that contributes to the well-being of patients in Japan and around the world through both in-house and collaborative research,” said Makoto Inoue, President and Representative Director of Otsuka Pharmaceutical Co., Ltd. “By introducing 4D-150 to the markets in Japan, and elsewhere in Asia and Oceania, we aim to help prevent vision loss through a single, potentially lifelong administration.”