Matthew Venezia

Matt Venezia (Alliance Global Partners) asked about the number of the 30 identified ZEVASKYN patients who are currently on background VYJUVEK or have previously failed VYJUVEK.

Answer

Madhav Vasanthavada (Chief Commercial Officer, Abeona) stated that the company does not have direct visibility into the exact number of patients on or having failed VYJUVEK. However, he expects the vast majority would be, given the unmet need for multiple treatment options in the RDEB community, and noted that prior use of other gene therapies helps with the prior authorization process.

Matthew Venezia asked about turnover on the FDA review team and its potential impact, and also inquired about the company's expected expense run rate into 2026.

Answer

CEO Linda Marbán stated they will have more clarity on the FDA team after their meeting but stressed that the data's strength should transcend any personnel changes. CFO AJ Bergmann indicated that the expense profile will shift upon regulatory clarity, with potential capital injections from a PRV sale and milestone payments funding commercial launch activities.

Matthew Venezia asked if other Latin American rice-producing countries have regulatory frameworks similar to Ecuador's and inquired about the current use of the herbicide Clethodim by rice farmers in the region.

Answer

Interim CEO Peter Beetham explained that Ecuador's approval is significant because it strictly prohibits GMOs, and its favorable determination for Cibus's traits sets a positive precedent for other Latin American countries. Beetham and CSO Gregory Gocal clarified that Clethodim is an approved herbicide in South America but is not currently used on rice, as it would kill the crop; Cibus's trait provides resistance, making it a new and valuable tool for weed management for rice farmers.

Matthew Venezia asked which traits and crops Cibus is prioritizing for resource allocation. He followed up with a technical question on soybean regeneration and another on the royalty timeline for pod shatter reduction (PSR) in Canada and the EU.

Answer

Interim CEO Peter Beetham reiterated focus on the 3-crop, 5-trait pipeline, with particular emphasis on rice, advanced traits in canola, and advancing the soybean platform. Regarding soybeans, he and CSO Greg Gocal clarified their focus is on an operational platform for elite commercial genetics, not just genotype-specific regeneration, and noted high editing rates have been achieved. For PSR, Peter Beetham confirmed the 2026-2028 royalty timeline for canola remains unchanged and is not currently accelerated by the EU news.

Matthew Venezia of Alliance Global Partners questioned if recent technological success confirms the 3-5 year product timeline, asked for a comparison of Cibus's protoplast regeneration versus competitor methods, and inquired about the herbicide labeling strategy for Latin America.

Answer

COO Peter Beetham and CEO Rory Riggs affirmed that the 12-month germplasm-to-greenhouse cycle validates their 3-to-5 year commercialization timeline. Beetham differentiated their single-cell protoplast system by highlighting its efficiency for complex edits and its faster, cleaner regulatory path compared to competitor methods that require segregation steps. He also stated the partnership with the global company Alba could be extended beyond the U.S. to cover regions like Latin America.