Executive Summary

Q1 2014 narrowed losses and burn: net loss attributable to CBLI was $1.59M ($0.03/share) vs $9.76M ($0.22/share) in Q1 2013, driven by lower operating expenses and a favorable non‑cash warrant revaluation; consolidated monthly cash burn(~~$1.0M) and standalone burn(~~$0.8M) were materially below guidance .
Revenue was essentially flat at $1.33M vs $1.37M in Q1 2013, with mix shifting away from U.S. government to Russian Federation contracts tied to Entolimod oncology and Mobilan grants .
Execution milestones: pre‑EUA meeting with FDA targeted for July; CBL0137 Phase 1 IV in cohort 3 and oral in cohort 7 with interim oral data planned in Q3; CBL0102 Phase 1 achieved recommended Phase 2 dose and signs of activity; healthy subject studies for Entolimod and CBLB612 advancing in Russia .
Liquidity runway reiterated into Q1 2015; subsequent to the quarter, company reduced debt via $3.5M private placement and $4M loan paydown with Hercules (catalyst to de‑risk balance sheet) .
No Wall Street consensus estimates were available from S&P Global for STAB for Q1 2014; beat/miss vs Street cannot be determined (S&P Global consensus unavailable).

What Went Well and What Went Wrong

What Went Well

Material OpEx reduction: “Research and development expenses for Q1 2014 decreased by $2.9 million or 54%… reported at $2.4 million… [drivers] completion of… NHP trial, narrowed Panacela, and completion of CBL0102 study.”
Oncology progress: “Dosing of the third cohort is underway in the intravenous study, and recruitment of our seventh cohort was recently initiated in the oral studies… interim report… in the third quarter.”
Regulatory path clarity: “Preparations are well underway for July meeting with the U.S. Food and Drug Administration to evaluate the potential for a pre‑emergency use authorization (pre‑EUA) submission for the Entolimod radiation countermeasure program.”

What Went Wrong

Funding headwind: BARDA terminated negotiations for Entolimod radiation countermeasure “noting that all such negotiations are subject to the availability of funds,” forcing pivot to pre‑EUA path and partnerships .
Revenue mix shift indicates reduced U.S. support: “Revenue… flat… [but] shift… from the US government… to the Russian Federation related to… grants… for Entolimod oncology and Mobilan.”
NASDAQ bid deficiency notice (prior quarter context): Company did not meet $1.00 minimum bid; risk of delisting if not remedied, requiring strategic actions (reverse split option) .

Financial Results

Metric	Q1 2013	Q4 2013	Q1 2014
Revenue ($USD)	$1,367,472	$3,871,632	$1,334,254
Net Loss attributable to CBLI ($USD)	$(9,764,323)	$(365,247)	$(1,585,372)
EPS, basic & diluted ($USD)	$(0.22)	$(0.01)	$(0.03)
Research & Development ($USD)	$5,331,615	$4,616,068	$2,439,773
General & Administrative ($USD)	$3,483,372	$2,251,722	$2,413,543
Total Operating Expenses ($USD)	$8,814,987	$6,867,790	$4,853,316
Loss from Operations ($USD)	$(7,447,515)	$(2,996,158)	$(3,519,062)

KPIs and Liquidity

KPI	Q1 2013	Q4 2013	Q1 2014
Cash & Equivalents (end of period, $USD)	$19,769,013	$10,048,466	$13,391,697
Short‑term Investments ($USD)	$2,633,944	$305,538	$280,213
Restricted Cash ($USD)	$1,577,920	$2,921,724	$2,679,559
Deferred Revenue ($USD)	$3,314,918	$1,069,438	$1,086,720
Consolidated Net Monthly Cash Burn ($USD)	$(2,410,051)	N/A	$(1,012,365)
CBLI Standalone Net Monthly Cash Burn ($USD)	$(1,537,060)	N/A	$(763,578)
Weighted Avg Shares (basic)	44,826,576	45,170,429	49,968,131

Segment breakdown: Revenue is grants/contracts; no segment reporting. Mix shifted from U.S. government (down ~$400K YoY) toward Russian Federation grants tied to Mobilan and oncology programs .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance / Actual	Change
Monthly Cash Burn – CBLI Standalone ($USD)	CY 2014 avg	$1.1–$1.2M per month	Q1 actual ~$0.8M per month; guidance maintained	Maintained; Q1 favorable vs guidance
Monthly Cash Burn – Consolidated ($USD)	CY 2014 avg	$1.7–$1.8M per month	Q1 actual ~$1.0M per month; guidance maintained	Maintained; Q1 favorable vs guidance
Liquidity runway (CBLI standalone)	Through	Into Q1 2015	Reiterated into Q1 2015	Maintained
Entolimod radiation countermeasure spending	FY 2014	20–25% of 2013 spending	Biodefense spending down; drivers consistent with guidance	Maintained directional
G&A trend	FY 2014	~10% reduction overall	Q1 G&A down YoY drivers; directional maintained	Maintained

Earnings Call Themes & Trends

Topic	Previous Mentions (Q3 2013, Q4 2013)	Current Period (Q1 2014)	Trend
Entolimod pre‑EUA strategy	Dose conversion work; pre‑EUA targeted; FDA meeting request	July FDA meeting planned; compiling pre‑EUA sections	Progressing toward regulatory milestone
BARDA funding	Active negotiation noted	Negotiations terminated due to lack of funds; pivot to pre‑EUA	Funding pivot; partnership emphasis
CBL0137 development	IV trial initiated; oral cohorts enrolling	IV cohort 3; oral cohort 7; interim oral data in Q3	Advancing dose escalation; nearer data readout
CBL0102 outcome	Study nearing readout	Phase 1 achieved RP2D (400 mg/day) with partial regression and disease stabilization	Completed Phase 1 with signals
Healthy subject studies (Entolimod, CBLB612)	Planned/granted funding	On track to start later in year; design endpoints specified	Execution starting
Financing & liquidity	Hercules loan, Russian contracts	Runway into Q1’15; burn favorable; pursuing strategic financing options	Strengthened plan; later debt reduction
Market/Listing	NASDAQ bid price deficiency notice	Management acknowledged share price pressure; director nominees & governance actions	Governance refresh; compliance risk remains

Management Commentary

“Execution of our operational objectives for 2014 is on schedule… preparations are well underway for our July meeting with the U.S. Food and Drug Administration to evaluate the potential for a pre‑EUA submission for the Entolimod radiation countermeasure program.” — CEO Yakov Kogan .
“CBLI’s consolidated monthly cash burn was $1 million, which favorably compares to our guidance of $1.7 million or $1.8 million per month… we continue to believe CBLI standalone cash resources will last into the first quarter of 2015.” — CFO Neil Lyons .
“Very encouraged by the outcome of [CBL0102]… recommended Phase 2 dose of 400 milligrams per day was established… partial tumor regression… disease stabilization in four other patients.” — CEO Yakov Kogan summarizing program .
“Partnering in the Entolimod radiation countermeasure program is paramount… we do not wish to remain solely dependent on government funding.” — CEO Yakov Kogan .

Q&A Highlights

FDA July meeting scenarios: Management expects several months to compile the pre‑EUA dossier after a positive meeting; no formal PDUFA timelines for pre‑EUA .
Entolimod oncology Phase 1: Dose escalation continues; further information after MTD identification and better DLT characterization; no unusual drug‑related events seen .
Pre‑EUA goal clarified: Next step post‑meeting is submitting the pre‑EUA application; team is compiling package sections now .
Resourcing and medical leadership: Acting CMO (Dr. Langdon Miller) engaged; search for permanent CMO not active given satisfactory progress .

Estimates Context

S&P Global Wall Street consensus estimates for Q1 2014 EPS and revenue were unavailable for STAB; as a result, comparison vs Street and beat/miss determination cannot be made (S&P Global consensus unavailable).

Key Takeaways for Investors

Near‑term catalysts: FDA July pre‑EUA meeting; Q3 interim oral CBL0137 readout; initiation of healthy subject studies for Entolimod and CBLB612 — potential to shift regulatory narrative and de‑risk oncology assets .
Burn trending materially below guidance; liquidity runway into Q1’15 provides time to execute milestones; subsequent debt reduction strengthens balance sheet positioning .
Revenue flat but mix shifted away from U.S. government to Russian Federation grants; expect continued variability given contract timing; focus remains on data readouts to attract partners .
Regulatory path is tangible (pre‑EUA) despite BARDA funding setback; partnership strategy emphasized to reduce funding concentration risk .
Oncology optionality: CBL0102 showed signals; CBL0137 advancing; these programs can create medium‑term value independent of radiation countermeasure trajectory .
Trading implications: Watch for pre‑EUA meeting outcome and Q3 CBL0137 interim; favorable burn and any financing on improved terms could be stock catalysts; conversely, regulatory delays or lack of additional funding may pressure shares .

Sources: Q1 2014 8‑K earnings press release and financial statements ; Q1 2014 earnings call transcript ; Q4 2013 8‑K press release and call ; Jan 23, 2014 BARDA update 8‑K ; June 16 & 20, 2014 8‑Ks (governance/ATM and debt reduction) .

Statera Biopharma, Inc. (STAB)·Q1 2014 Earnings Summary