Analyst Conference Summary

biotechnology

conference date: November 6, 2025 @ 2:00 PM Pacific Time
for quarter ending: September 30, 2025 (third quarter, Q3)

Forward-looking statements

Overview: Continues critical Phase 3 flu trial.

Basic data (GAAP):

Revenue was $0, flat sequentially from $0, and down from $ million year-earlier.

Net Income was negative $83 million, down sequentially from negative $25.7 million, and down from negative $16 million year-earlier.

EPS (Earnings per Share), diluted, were negative $3.10, down sequentially from negative $1.65, and down from from negative $2.45 year-earlier. Sharecount increased significantly during the year.

Guidance:

Phase 3 program is funded through completion.

Conference Highlights:

Jeffrey Stein, CEO, said "With our Phase 3 ANCHOR study now over 50 percent enrolled, we expect to achieve target enrollment of 6,000 participants by December 2025 and thereby advance CD388 as a potential universal preventative for people at increased risk of complications from influenza as well as those seeking alternatives to flu vaccines. Based on constructive feedback from the FDA, the ANCHOR study population has been expanded to include generally healthy adults over the age of 65 in addition to individuals with certain comorbidities or compromised immune status. This change more than doubles the target population potentially eligible to receive CD388. Our successful financing this summer has provided us with a strong balance sheet that we expect to be sufficient to fully fund our Phase 3 development program through completion." Cloudbreak platform uses drug-Fc conjugates (DFCs) to engineer therapies.

The CD388 Anchor Phase 3 trial for flu (A and B strains) is over 50% enrolled. There will be an interim analysis in Q1 2025. Hopes to get FDA approval based on the single trial. Received Breakthrough Therapy designation. CD388 in Q2 2025 reported positive Phase 2b results in seasonal influenza. Single doses of 450mg, 300mg and 150mg of CD388 conferred 76.1%, 61.3% and 57.7% protection, respectively. An end of Phase 2 meeting with the FDA has been requested. Preclinical CD388 data was published in March 2025 in Nature Microbiology. Two posters, one on preliminary safety data in the 2b trial and one on Phase 3 planned doses, were presented at the March 2025 ICAR (International Conference on Antiviral Research) conference.

Acquired IPRD in Q3 2025 related to a $45.0 million milestone incurred under the Janssen License Agreement, upon dosing the first five subjects in our ANCHOR study, which will be paid to Janssen in the fourth quarter of 2025.

Cash and equivalents ended at $477 million, down sequentially from $517 million.

Total operating expenses were $88 million, consisting of: R&D $36 million, G&A $8 million, and acquired in-process research and development $45 million. Other expense $0 million, interest income $5 million.

Q&A selective summary:

Interim analysis, enrollment needed? The powering assumption for the Northern hemisphere season will be tested. We will only be told if the powering assumption has been met. If not, then we will need to add additional participants.

So no efficacy data with the interim analysis? No, no efficacy data from interim.

Subgroups? No efficacy estimates on December investor day, but we can say what subgroups we have enrolled.

Mild patients in label? Now trial includes anyone who is 65+. High risk populations are focussed on the moderate to high risk levels.

Flu vaccinations with CD388 in trial? Our estimate of the flu vaccination rate was 65%. That impacts the powering of the study. We cannot share the vaccination rate in the ongoing study.

Manufacturing scale up? Partnered with Ushi (sp?). Progressing well. Will have adequate capacity for launch. Will have to scale up from there, which will involve setting up a U.S. manufacturing capability. That will be partly funded by the Barda grant.

Resistance to CD388? Phase 2b data analysis did not show a point where there is 100% protection, but that is because of a high innoculum, not resistance. Will report when the analysis is complete.

We would like to fully enroll the trial before we get to the first peak of the flu season.

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