Analyst Conference Summary

biotechnology

conference date: August 7, 2025
for quarter ending: June 30, 2025 (second quarter, Q2)

Forward-looking statements

Overview: The Phase 2b CD388 trial for flu had positive data.

Basic data (GAAP):

Revenue was $0, flat sequentially from $0, and down from $0.3 million year-earlier.

Net Income was negative $25.7, down sequentially from negative $23.5 million, and up from negative $94.2 million year-earlier.

EPS (Earnings per Share), diluted, were negative $1.65, up sequentially from negative $1.66, and up from from negative $19.99 year-earlier. Sharecount increased significantly during the quarter and year.

Guidance:

none

Conference Highlights:

Jeffrey Stein, CEO, said "The highly compelling results of our Phase 2b NAVIGATE trial for CD388 and subsequent financing puts us in a position of strength to execute on our Phase 3 plan to examine the potential of CD388, a non-vaccine solution, to provide single-dose per season, universal protection against influenza in individuals at greatest risk from influenza. Our planned Phase 3 development program focuses initially on individuals with compromised immune systems or those at a heightened risk of severe illness due to underlying health conditions. We have submitted an End-of-Phase 2 meeting request to the FDA to discuss our planned Phase 3 study design and start timing. " Cloudbreak platform uses drug-Fc conjugates (DFCs) to engineer therapies.

In Q2 raised $402.5 million in cash with a public offering. Required about 10.3 million shares to be issued.

Cidera Therapeutics in Q2 was addes to the Russell 2000 and 3000 indexes.

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. CD388 does not depend on the patient's immune system, so may be best in class. However, may require 2 flu seasons to conduct the Phase 3 trial.

Cash and equivalents ended at $517 million, up sequentially from $175 million.

Total operating expenses were $27 million, consisting of: R&D $25 million, G&A $7 million, and a gain from reversal of indirect tax liabilities of $4 million. Other expense $0 million, interest income $2 million.

Q&A selective summary:

Type C meeting v. planned Phase 3 design meeting? We do not expect substantial differences from the Type C meeting. But now we have Phase 2b results.

BARDA grant? We expect, if funded, the base period would fund onshoring to the U.S. Optional funding could support clinical studies. For an actual order for bird flu we would need an Emergency Use Authorization.

FDA meeting is scheduled before the end of August. We will report to investors when we receive the minutes of the meeting from the FDA.

We do anticipate conducting a redosing study, using a subset of the 2b study, at different doses.

Cash runway? Believe funded through the end of the Phase 3 program.

Sanofi projected flu vaccine drop? There is pressure on vacines now. We believe CD388 will have a different commercial model.

Science conferences? Submitted, but not accepted yet, ISIRV. PK-PD relationships also submitted for a fall conference.

Oncology program is an asset we could advance, but there is no timeframe for that at present.

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