Executive Summary

Statera reported unaudited preliminary FY2021 results: revenue of $1.487M (vs. $0 in FY2020) driven by the ImQuest acquisition; net loss widened to $34.9M, reflecting higher R&D and G&A tied to pipeline expansion and merger-related costs .
No discrete Q4 2021 quarterly financials or earnings call transcript were provided; results were communicated via an Item 2.02 8-K preliminary FY release .
Clinical/regulatory momentum in Q4: FDA lifted the clinical hold on Entolimod (ARS) (Dec 1) and first patient was dosed in STAT-205 (acute COVID-19) (Dec 20), adding near-term data catalysts and execution signals .
Management highlighted plans to initiate enrollment in a pivotal Phase 3 trial for STAT-201 (pediatric Crohn’s) in 2022 and to use proceeds from recent financings to fund programs (crohn’s, COVID-19), framing development milestones as prospective stock catalysts .

What Went Well and What Went Wrong

What Went Well

FDA lifted the clinical hold on Entolimod for ARS, enabling program continuation and exploration into hematology indications (neutropenia/anemia), a strategic regulatory win ahead of planned oncology/hematology development work in 2022 .
First patient randomized/dosed in STAT-205 acute COVID-19 study in December, with preliminary data targeted for 2022, underscoring clinical execution in virology .
Management emphasized preparedness to achieve “numerous milestones in 2022,” including Phase 3 STAT-201 enrollment and advancing STAT-205, linking financing proceeds to program initiation: “we plan to use proceeds…to initiate patient enrollment in the second quarter…targeting…preliminary data this year” .

What Went Wrong

Net loss rose sharply year over year to $34.9M (vs. $12.1M), primarily due to significant operating cost increases (R&D +125% YoY; G&A +276% YoY), reflecting higher clinical program spend and merger-related/public company costs .
Other expense increased to $4.33M (vs. $1.59M), driven by interest and non-operating expense, highlighting the cost of capital and balance sheet burden during integration and scale-up .
Q4-specific financials and an earnings call transcript were not provided; combined with unavailable S&P Global consensus estimates mapping, this limits direct quarter-over-quarter comp analysis and the ability to benchmark against Street expectations .

Financial Results

FY Performance vs Prior Year

Metric	FY 2020	FY 2021
Revenue ($USD)	$0	$1,487,036
Cost of Revenues (% of Revenue)	N/A (no revenue)	33%
Operating Costs ($USD)	$10,501,668	$31,587,009
Other Expense ($USD)	$1,592,193	$4,328,823
Net Loss ($USD)	$(12,093,861)	$(34,892,762)

Notes: FY2021 revenue growth reflects ImQuest acquisition; operating costs increased on R&D (Crohn’s, COVID-19 expansion) and G&A (merger/public company costs, compensation/stock comp, insurance) .

Quarterly Trend (available disclosures)

Metric	Q2 2021	Q3 2021	Q4 2021
Revenue ($USD)	$0	$236,519	Not disclosed in preliminary FY release
Net Loss ($USD)	$(667,094)	$(12,733,250)	Not disclosed in preliminary FY release
EPS (Basic & Diluted)	$(0.04)	$(0.47)	Not disclosed in preliminary FY release

Balance Sheet and Operating KPIs (as last reported intra-quarter)

KPI	Q3 2021
Cash, Cash Equivalents & Restricted Cash ($USD)	$14,216,349
Cash, Cash Equivalents ($USD)	$9,216,349
Restricted Cash ($USD)	$5,000,000
Deferred Revenue ($USD)	$506,032
Long-term Debt ($USD)	$12,916,667

Revenue Composition Indicator (Q3)

Period	ImQuest Research Services Revenue ($USD)
Q3 2021	$236,519

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Financial Guidance (Revenue, EPS, Margins)	FY2021/Q4 2021	None provided	None provided	Maintained (no formal guidance)
Clinical Milestones	2022	Prior expectations	CEO reiterated plan to initiate Phase 3 STAT-201 enrollment in 2022; STAT-205 preliminary data targeted in 2022	Reaffirmed execution timeline

Note: No formal numeric financial guidance ranges were disclosed in the Q4/FY preliminary release; commentary focused on clinical timelines and use of proceeds .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2 2021)	Previous Mentions (Q3 2021)	Current Period (Q4 2021)	Trend
R&D execution: STAT-201 (pediatric Crohn’s)	Phase 3 enrollment expected by year-end 2021; post-merger pipeline enhancement	End-of-Phase 2 completed; site activation by YE; Phase 3 to start next year	CEO reaffirmed plans to initiate Phase 3 enrollment in 2022	Steady progression toward pivotal trial
COVID-19 program: STAT-205	Phase 1b/2 trials expected by YE 2021	IRB approval; first patient expected in Nov; preliminary readouts mid-2022	First patient randomized/dosed; preliminary data targeted in 2022	Execution milestone achieved
Entolimod (ARS/hematology)	Reviewing CBLI pipeline; exploring neutropenia/anemia indications	Plan to strengthen development in hematology/oncology; discussions with FDA/PI	FDA lifted clinical hold enabling ARS continuation and hematology exploration	Regulatory overhang removed; pathway clearer
Financing/capital plan	Well financed; $90M commitments (GEM + Avenue/Adit)	Cash $14.4M; seeking up to $60M additional commitments	Proceeds to fund STAT-201 and STAT-205 programs	Ongoing capital sourcing supports pipeline
Corporate identity/merger integration	CBLI/Cytocom merger; Nasdaq listing as CBLI	Rebranding to Statera; ticker STAB; integration and alliances	Continued clinical/regulatory updates under STAB brand	Integration narrative maintained

Management Commentary

CEO on 2022 milestones and funding use: “we plan to use proceeds from our recent registered direct offering to initiate patient enrollment in the second quarter…use of proceeds will include the enrollment of patients with acute COVID-19 infection in our STAT-205 study, from which we are targeting to have preliminary data this year.”
CEO on Entolimod clinical hold: “We are pleased that the FDA’s clinical hold questions have been successfully addressed, allowing us to continue our clinical work in ARS and explore new indications for Entolimod in hematology…”
CEO on STAT-205 study start: “We look forward to working with the researchers to explore the potential of STAT-205… We expect preliminary trial results to be reported in 2022.”
CFO (Q3 call) on cash and funding strategy: cash of ~$14.4M at Q3; engaged with investors for up to $60M in new debt/equity commitments to fund 2022 objectives .

Q&A Highlights

Financing runway and capital structure: CFO outlined cash position ($14.4M), restricted cash release contingent on additional equity raises, and pursuit of ~$60M in commitments to fund 2022 budget and objectives .
R&D allocation: CFO detailed R&D expense mix, with focus on Crohn’s (STAT-201), post-acute COVID, pancreatic cancer, and normalization of prior one-time patent costs impacting YoY comparisons .
Merger accounting: CFO explained survivors (accounting and legal), timing of combining P&L and balance sheet elements post-close, affecting period-to-period comparability until 2022 .

Note: No Q4 2021 earnings call transcript was available; Q&A highlights reflect the Q3 2021 call -.

Estimates Context

Wall Street consensus estimates (S&P Global) for Q4/FY2021 revenue/EPS were unavailable due to missing CIQ mapping for STAB, limiting direct comparison to Street expectations [SpgiEstimatesError for STAB].
Implication: Investors should anchor on disclosed FY results and intra-quarter updates; until S&P mapping is established, model updates will rely on company-reported figures and forthcoming audited filings .

Key Takeaways for Investors

Execution momentum in Q4: FDA hold lift on Entolimod and first STAT-205 patient dosed create near-term data/regulatory catalysts; watch for 2022 updates (STAT-205 preliminary data; entolimod hematology plans) .
Pipeline inflection potential: STAT-201 Phase 3 (pediatric Crohn’s) initiation in 2022 is a pivotal value driver; clinical timelines reaffirmed by management .
Financial profile: FY2021 net loss widened with operating spend scaling; balance sheet shows cash plus restricted cash at Q3, with ongoing capital initiatives to fund 2022 objectives; monitor dilution and debt costs .
Revenue base nascent: FY2021 revenue originated from ImQuest services; recurring visibility depends on contract cadence; deferred revenue at Q3 ($0.506M) signals pipeline of work but quarterly revenue will be lumpy .
Modeling caution: Absent Q4 granularity and S&P consensus, use FY disclosures and Q3 trends; expect elevated OpEx from clinical trial starts and G&A as public company; catalysts may drive stock volatility around data and regulatory updates .
Corporate integration: Rebranding and merger integration underpin a diversified TLR platform (TLR4/9 antagonists; TLR5 agonists), broadening optionality across autoimmune, hematology, oncology, and virology programs .

Statera Biopharma, Inc. (STAB)·Q4 2021 Earnings Summary