Executive Summary

Q3 2025 EPS of -$0.19 beat Wall Street consensus of -$0.215; OpEx declined materially YoY on lower clinical spend, narrowing net loss vs prior year * .
Norovirus CDI-988 program advanced with FDA IND clearance; however, the Phase 1b norovirus challenge study timeline shifted, with enrollment now expected to begin in Q1 2026 (vs “planned later this year” in Q2) — a notable delay .
Balance sheet strengthened via $4.7M September registered direct offering and $1.03M October insider private placement; NIH SBIR award adds $0.5M non-dilutive funding .
Going concern risk reiterated: cash of $7.7M as of 9/30/25 and expected need for additional capital; warrants outstanding could add cash if exercised but also imply potential dilution .

What Went Well and What Went Wrong

“We expect to begin enrolling participants in the first quarter of 2026 for our norovirus challenge study evaluating CDI-988… This study will provide an initial assessment of CDI-988 for both prevention and treatment of norovirus infection.” — Sam Lee, Ph.D., President & co-CEO .
NIH SBIR Phase I award (~$500,000) to advance influenza A/B replication inhibitor program validates platform and adds non-dilutive capital .
Operating discipline: R&D fell to $0.95M from $3.24M YoY and G&A to $1.14M from $1.80M YoY; net loss narrowed to $2.05M from $4.94M YoY .

Timeline slip: Phase 1b norovirus challenge study pushed to Q1 2026 from “planned later this year” in Q2 2025 press release — potential catalyst deferral .
Going concern disclosed; management expects current resources insufficient beyond 12 months absent additional financing .
CC-42344 Phase 2a completed without efficacy analyses due to trial conduct issues, limiting near-term data catalysts; development continues but requires additional work .

Metric	Q3 2024	Q2 2025	Q3 2025
EPS (GAAP, $)	-$0.49	-$0.20	-$0.19
EPS Consensus Mean ($)	-$0.57*	-$0.30*	-$0.215*
R&D Expense ($USD Millions)	$3.24	$1.12	$0.95
G&A Expense ($USD Millions)	$1.80	$0.99	$1.14
Total Operating Expenses ($USD Millions)	$5.04	$2.11	$2.09
Net Loss ($USD Millions)	$4.94	$2.06	$2.05

Values with asterisks retrieved from S&P Global.

KPI and Balance Sheet Trend

KPI	Q1 2025	Q2 2025	Q3 2025
Cash and Equivalents ($USD Millions)	$6.92	$4.77	$7.73
Working Capital ($USD Millions)	$6.9	$4.9	$7.3
Shares Outstanding (Millions)	10.2	10.2	13.0
Accounts Payable & Accrued ($USD Millions)	$1.62	$1.51	$1.19
Total Equity ($USD Millions)	$7.30	$5.33	$7.67

Notes: Company operates a single segment; no revenue reported and no product sales to date .

Metric	Period	Previous Guidance	Current Guidance	Change
CDI-988 Phase 1b Norovirus Challenge Study Start	Clinical timing	“planned later this year” (2025)	Enrollment expected to begin Q1 2026	Lowered/Delayed
CC-42344 (oral) Phase 2a	Study status	Extension planned due to low infection (Dec 2024)	Phase 2a completed; favorable safety; no efficacy analyses reported; continue development	Maintained continuation, with data limitations
Funding	Capital adds	ATM sales modest ($0.15M net by Q3); planned study funding	$4.18M net registered direct; insider placement $1.03M; NIH SBIR $0.5M	Raised

No financial guidance given for revenue, margins, OpEx, tax rate, or dividends .

No Q3 2025 earnings call transcript was found; synthesis below leverages press releases and 10-Q commentary [List: 0 for earnings-call-transcript].

Topic	Previous Mentions (Q1 & Q2 2025)	Current Period (Q3 2025)	Trend
R&D execution	CDI-988 Phase 1 SAD/MAD favorable safety; planning human challenge study “in coming months” (Q1) and “later this year” (Q2)	FDA IND cleared; enrollment expected Q1 2026; sustained favorable safety	Progress with timeline slip
Regulatory/legal	MHRA authorization for CC-42344 Phase 2a (UK); FDA Phase 1 CDI-988 ongoing	IND clearance for CDI-988 Phase 1b; SBIR award (NIH/NIAID)	Positive regulatory milestones
Funding/liquidity	Cash $6.9M (Q1), $4.8M (Q2); need for capital implied	Cash $7.7M; going concern; financings and NIH award; warrants outstanding 5.74M	Improved cash, ongoing risk
Product performance	CC-42344 active vs H5N1; CDI-988 broad activity vs GII.17	CC-42344 Phase 2a safety positive; no efficacy analyses; CDI-988 safety reiterated	Mixed: safety ok, efficacy data lacking
R&D tax credits	Refundable credits reduce R&D expense	$513k receivable accrued YTD	Stable support

“We expect to begin enrolling participants in the first quarter of 2026 for our norovirus challenge study evaluating CDI-988… This study will provide an initial assessment of CDI-988 for both prevention and treatment of norovirus infection.” — Sam Lee, Ph.D., President & co-CEO .
“Together with the non-dilutive SBIR award, we strengthened our balance sheet through two recent at-the-market financings under Nasdaq rules… This enhanced cash position supports the continued development of our product pipeline, including our potentially groundbreaking norovirus program.” — James Martin, CFO & co-CEO .
“The FDA’s clearance of our CDI-988 study is an important milestone… CDI-988 is the first novel, oral drug candidate for the prevention and treatment for norovirus infection…” — Sam Lee, PhD .
“This award provides non-dilutive funding to advance our influenza A/B program… further validates our structure-based drug discovery platform technology.” — Sam Lee, PhD .

No Q3 2025 earnings call/Q&A transcript available; no public Q&A to report [List: 0 for earnings-call-transcript].

Metric	Q3 2024	Q2 2025	Q3 2025
Primary EPS Consensus Mean ($)	-0.57*	-0.30*	-0.215*
Primary EPS - # of Estimates	3*	3*	2*
Revenue Consensus Mean ($USD Millions)	0.00*	0.00*	0.00*
Revenue - # of Estimates	2*	3*	3*
Target Price Consensus Mean ($)	8.00*	8.00*	8.00*

Values retrieved from S&P Global.

Comparison vs actual EPS:

Q3 2025: -$0.19 actual vs -$0.215 consensus — beat driven by lower R&D and G&A YoY/quarterly * .
Q2 2025: -$0.20 actual vs -$0.30 consensus — beat amid reduced clinical spend *.
Q3 2024: -$0.49 actual vs -$0.57 consensus — beat with higher OpEx base then * .

EPS beat reflects OpEx discipline; sustained reductions in R&D and G&A have materially narrowed losses YoY .
Timeline delay for CDI-988 Phase 1b challenge study defers a key efficacy catalyst into Q1 2026; adjust near-term catalyst expectations accordingly .
Financing plus NIH SBIR adds liquidity, but going concern persists; expect continued capital raises (ATM, registered/direct, warrants) with associated dilution risk .
CC-42344 delivered clean safety in Phase 2a but lacked efficacy readouts due to conduct issues; program remains strategic but requires further development to unlock value .
Warrants outstanding (~5.74M) could supply cash upon exercise but cap upside; monitor execution and capital structure developments .
R&D tax credits (Australia) help offset expenses; maintain awareness of jurisdictional support to manage cash burn .
Near-term trading implications: positive on cost control and funding; cautious on catalyst timing slippage; medium-term thesis depends on generating efficacy data in norovirus challenge and advancing influenza A/B candidate .