Executive Summary

Q4 2021 marked a return to GAAP profitability driven by one-time gains and collaboration revenue recognition: revenue rose to $7.7M and GAAP EPS reached $0.74, versus a net loss and $(1.14) EPS in Q4 2020 .
Positive operational progress: initial exoSTING safety/PK/PD data readout completed for dose cohorts 1–3, IND cleared for exoASO-STAT6, and exoIL-12 CTCL data anticipated late 1H 2022, setting multiple clinical catalysts in 1H 2022 .
Cost structure steady but elevated given pipeline execution: Q4 R&D $17.4M and G&A $6.9M; cash and equivalents ended at $76.9M, down from $98.6M in Q3 reflecting burn and transaction timing .
Estimate comparisons unavailable via S&P Global for CDAKQ; as a result, we anchor on reported results and prior-period trajectories .

What Went Well and What Went Wrong

What Went Well

GAAP profitability in Q4 2021 from collaboration revenue recognition and a $33.3M gain on disposition related to the Lonza agreement; revenue jumped to $7.7M and net income was $16.7M .
Pipeline momentum: “We are making a strong start in 2022… plan to report clinical data for two… and initiate clinical development for a third candidate all in the first half of the year,” said CEO Douglas E. Williams, highlighting exoSTING, exoIL-12, and exoASO-STAT6 .
exoSTING clinical progress with dose cohorts advanced to 4–5 and follow-up ongoing across cohorts; recommended Phase 2 dose expected late 1H 2022 .

What Went Wrong

Enrollment headwinds: exoIL-12 CTCL patient enrollment impacted by COVID-related restrictions in the UK, pushing initial safety/PK/PD/efficacy data to late 1H 2022 .
Cash drawdown: cash and equivalents decreased to $76.9M at year-end from $98.6M at Q3 and $113.7M at Q2, reflecting operational spend and transaction timing .
Ongoing elevated OpEx: Q4 R&D of $17.4M and G&A of $6.9M, with R&D up vs. Q4 2020 on personnel-related costs and engEx platform development, sustaining losses outside one-time gains .

Financial Results

Metric	Q2 2021	Q3 2021	Q4 2021
Revenue ($USD Millions)	$0.890	$1.157	$7.697
GAAP EPS ($USD)	$(0.99)	$(0.97)	$0.74
Net Income (Loss) ($USD Millions)	$(21.809)	$(21.702)	$16.662
R&D Expense ($USD Millions)	$15.419	$15.467	$17.419
G&A Expense ($USD Millions)	$6.937	$7.186	$6.919

Notes:

Q4 2021 outperformance vs prior quarter driven by $7.0M revenue recognized from early termination of Sarepta research agreement in Q4 and a $33.3M gain on disposition tied to the Lonza agreement .
Vs prior year (Q4 2020): Q4 revenue increased from $1.639M to $7.697M and EPS improved from $(1.14) to $0.74, reflecting collaboration revenue recognition and the Lonza-related gain .

Segment breakdown: Not applicable (collaboration revenue; no reported segments in press release) .

KPIs

KPI	Q2 2021	Q3 2021	Q4 2021
Cash & Equivalents ($USD Millions)	$113.7	$98.6	$76.9
Deferred Revenue (Current) ($USD Millions)	$9.117	$9.352	$12.963

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
exoSTING Phase 1/2 data (dose escalation)	Late 2021 vs 1H 2022	Initial safety/PK/PD from cohorts 1–3 expected Q4 2021	Safety/PK/PD and ORR from cohorts 1–5; recommended Phase 2 dose late 1H 2022	Extended timeline (broader cohort data, pushed to late 1H 2022)
exoASO-STAT6 IND and first-in-human	2H/Q4 2021 vs 1H 2022	IND filing planned 2H/Q4 2021	IND cleared; first-in-human dosing anticipated 1H 2022	Progressed (IND cleared), first-in-human timing set
exoIL-12 CTCL initial data	Year-end 2021 vs 1H 2022	Initial safety/PK/PD/efficacy by year-end 2021	Now anticipated late 1H 2022 due to UK site COVID restrictions	Delayed (COVID-related enrollment impact)

Financial guidance: The company did not provide quantitative financial guidance (revenue, margins, OpEx, tax, dividends) in Q4 materials .

Earnings Call Themes & Trends

No Q4 2021 earnings call transcript was available; themes below reflect press release narratives across Q2, Q3, and Q4.

Topic	Previous Mentions (Q2 2021)	Previous Mentions (Q3 2021)	Current Period (Q4 2021)	Trend
R&D execution & pipeline timing	exoSTING cohorts 1–3 data expected Q4 2021; exoIL-12 CTCL data by year-end; exoASO-STAT6 IND in 2H 2021	exoSTING patient dosing/follow-up proceeding; exoASO-STAT6 IND in Q4; exoIL-12 CTCL shifted to H1 2022	exoSTING data/ORR cohorts 1–5 and RP2D late 1H 2022; exoASO-STAT6 IND cleared, first-in-human 1H 2022; exoIL-12 CTCL data late 1H 2022	Mixed: execution intact, timelines extended
Manufacturing strategy	No Lonza collaboration mentioned	Strategic manufacturing collaboration with Lonza and sale of Lexington site; ~$65M in-kind services	$33.3M gain on disposition recognized from Lonza agreement drives Q4 profitability	Positive strategic alignment; near-term financial boost
COVID impacts on trials	Not highlighted	UK site restrictions slowing exoIL-12 CTCL enrollment	UK COVID restriction impact abating, enrollment options explored; data late 1H 2022	Improving operational conditions
Collaboration revenue drivers	Deferred revenue recognition ongoing	Deferred revenue; steady collaboration updates	Revenue recognition from Jazz ($10.9M from discontinuing STAT3) and Sarepta ($7.0M from early termination) underpin FY/Q4 revenue	One-time recognition; not recurring
Platform breadth (vaccines/gene delivery)	exoAAV/exoVACC preclinical data presented	SITC abstracts on exoASO-STAT6, exoSTING, exoSTING+exoIL-12	Pan-beta coronavirus vaccine progress; AACR and World Vaccine Congress presentations planned	Broadening preclinical scope

Management Commentary

“We are making a strong start in 2022… plan to report clinical data for two of our engineered exosome therapeutic candidates and initiate clinical development for a third candidate all in the first half of the year.” — Douglas E. Williams, Ph.D., President & CEO .
On platform breadth: “The emergence of programs in vaccines and gene delivery highlight the breadth of opportunity across multiple therapeutic areas with the engEx platform.” — Douglas E. Williams, Ph.D. .
Q3 tone on manufacturing strategy: “Our recently announced strategic collaboration with Lonza affirms that we are at the forefront of a promising new therapeutic modality.” — Douglas E. Williams, Ph.D. .

Q&A Highlights

No Q4 2021 earnings call transcript was available; therefore, Q&A themes, guidance clarifications, and tone shifts from analyst questions cannot be assessed for Q4 [ListDocuments returned no earnings-call-transcript for period] .

Estimates Context

S&P Global consensus estimates (EPS and revenue) for CDAKQ were unavailable in our data connector for this period; consequently, estimate comparisons are not presented and the recap is anchored on reported results and prior-period trajectories .

Key Takeaways for Investors

Q4 headline GAAP profitability was driven by non-recurring items (Lonza-related $33.3M gain and collaboration revenue recognition); underlying OpEx remains elevated to support clinical execution .
Multiple near-term clinical catalysts in 1H 2022 (exoSTING Phase 1/2 cohorts 1–5 readout and RP2D; exoASO-STAT6 first-in-human; exoIL-12 CTCL initial data) could re-rate sentiment and drive volatility; monitor enrollment and data quality .
Collaboration revenue in Q4 was largely tied to program discontinuations/terminations (Jazz STAT3, Sarepta research early termination), not indicative of recurring top-line trends; investors should model revenue conservatively absent new deals .
Cash declined to $76.9M at year-end, implying the company has runway but must balance clinical advancement with capital needs; watch for future financing or partnership milestones .
Manufacturing alignment with Lonza provides later-stage and potential commercial readiness, de-risking CMC and scale-up elements for exosome therapeutics .
COVID-related site constraints are easing, but timelines have shifted; trade around data releases with an understanding of calendar risk and potential further delays .
With S&P Global estimates unavailable, focus on absolute progress and non-GAAP-adjusted drivers; if future coverage improves, estimate beats/misses could become more meaningful .

Codiak BioSciences, Inc. (CDAKQ)·Q4 2021 Earnings Summary