Analyst Conference Summary

biotechnology

conference date: May 8, 2025
for quarter ending: March 31, 2025 (first quarter, Q1)

Forward-looking statements

Overview: The Phase 2b CD388 trial for flu data cutoff date was April 30; top-line data should be reported in June.

Basic data (GAAP):

Revenue was $0, donw from $1 million year-earlier.

Net Income was negative $23.5 million, down from negative $10.3 million year-earlier.

EPS (Earnings per Share), diluted, were negative $1.66, up from negative $2.28 year-earlier. Sharecount increased from 4.5 million to 14.2 million during the year.

Guidance:

none

Conference Highlights:

Jeffrey Stein, CEO, said "Coinciding with the end of the 2024-2025 flu season in the Northern Hemisphere, we have established April 30, 2025 as the data cutoff for the primary efficacy analysis of the 5,041 subjects dosed in the Phase 2b NAVIGATE clinical trial. We are expecting top-line results in late June of this year. The severity of the 2024-2025 flu season has provided an opportunity to discuss changes to the study's statistical analysis plan with the U.S. FDA to evaluate the potential statistical significance of CD388 versus placebo. We believe CD388 is highly differentiated from vaccines and monoclonal antibodies and we believe these differences can significantly improve upon the protective efficacy against influenza in healthy, high-risk, and immunocompromised patients with a single dose per flu season." Navigate was not intended to be powered for statistical significance. Phase 3 study is expected to start in spring of 2026, in the southern hemisphere.

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. CD388 does not depend on the patient's immune system, so may be best in class.

Cash and equivalents ended at $175 million, down sequentially from $196 million.

Total operating expenses were $24.3 million, consisting of: R&D $24.6 million, G&A $6.2 million, and a gain from reversal of indirect tax liabilities of $5.5 million. Other expense $0.1 million, interest income $1.9 million.

There will be a virtual R&D day on May 22.

Q&A selective summary:

Discussions with FDA on 2b? We have had discussions, will share the statistical plan update on May 22.

Definition of high-risk patient population? We are finalizing, will share May 22.

Is there an opportunity beyond high risk patients, and pricing? Our thinking has evolved. We see a substantial opportunity in the high-risk community. 20 million people have very severe forms of immune compromise, but we believe the moderately immune compromised population is larger. We believe pricing will be above vaccine pricing, it is not a vaccine and of high value to the patient population.

CD388 positioning, complementing vaccines? Initially aimed at high-risk population. If more effective, could expand into normal population that gets vaccines. Hospitalization data shows the need in the high-risk population. CD388 can be given in conjunction with vaccines.

Primary endpoint for study? Primary endpoint is preventative efficacy, that is evaluated by centrally confirmed influenza infection. 3 components: PCR positivity, temperature, and two clinical symptoms.

Expecting a dose-dependent response? Subjects ranged over time. We expect dose dependence, but also exposure dependence. Dosed highest dose first in calendar, lowest last.

PK data? At end of trial, likely a September analysis. CD388 has a long half life.

Cutoff date was chosen based on diminishing returns, from end of flu season.

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