Name: Statera Biopharma, Inc. Q1 2018 Earnings Call
Start: 2025-11-20 10:23:09.073028+00

Executive Summary

Q1 2018 revenue fell 60% year over year to $0.23M, with net loss improving to $(1.22)M and EPS at $(0.11), driven by a $0.51M non-cash gain from warrant liability revaluation and cost controls; revenue softness stemmed from lower DoD JWMRP activity and Incuron services .
Cash, cash equivalents, and short-term investments totaled $7.7M, with management asserting funding sufficiency for at least 12 months beyond the 10‑Q filing date .
Regulatory progress: EMA Day 120 questions received for the entolimod MAA; responses due by mid‑September 2018, with ongoing non‑human primate biocomparability analyses; FDA pre‑EUA review expected to resume post study completion .
No formal financial guidance or Wall Street consensus estimates available; near-term catalysts revolve around EMA/FDA feedback and execution on DoD‑funded studies in H2 2018 .

What Went Well and What Went Wrong

Non-cash warrant liability revaluation delivered ~$0.51M benefit, improving EPS to $(0.11) vs $(0.15) a year ago .
Cost discipline: R&D decreased ~6.7% to $1.34M and G&A fell ~6.5% to $0.73M, reflecting personnel and operating cost reductions .
Regulatory momentum: EMA Day 120 questions received and response plan underway; biocomparability study analyses ongoing to address comparability issues (“expected next step”) .

Revenue contracted to $0.23M (−$0.35M YoY), primarily due to reduced JWMRP activity and lower Incuron service revenue .
Loss from operations widened to $(1.84)M vs $(1.62)M in Q1 2017 on lower revenue despite cost reductions .
Equity value erosion: total CBLI stockholders’ equity declined to $1.04M from $2.20M at year‑end, underscoring continued pressure pending commercialization .

Metric	Q1 2017	Q4 2017	Q1 2018
Revenue ($USD)	$574,974	$870,351	$227,576
Net Loss ($USD)	$(1,663,694)	$(1,169,110)	$(1,224,610)
EPS (basic & diluted) ($USD)	$(0.15)	$(0.10)	$(0.11)
Loss from Operations ($USD)	$(1,619,448)	$(1,213,528)	$(1,836,087)
R&D Expense ($USD)	$1,416,998	$1,523,978	$1,336,470
G&A Expense ($USD)	$777,424	$559,901	$727,193

Balance Sheet and Liquidity

Metric	Dec 31, 2017	Mar 31, 2018
Cash & Equivalents ($USD)	$4,230,548	$4,586,340
Short-term Investments ($USD)	$4,561,357	$3,097,266
Total Assets ($USD)	$9,629,262	$8,369,723
Accrued Warrant Liability ($USD)	$1,041,455	$532,913
Total Stockholders’ Equity ($USD)	$7,408,370	$6,213,483

Revenue Program Breakdown

DoD Contract KPIs (as of March 31, 2018)

Program	Total Award Value ($USD)	Funded Award Value ($USD)	Cumulative Revenue ($USD)	Funded Backlog ($USD)	Unfunded Backlog ($USD)
JWMRP	$9,226,455	$9,226,455	$2,863,772	$6,362,683	$0
PRMRP	$6,573,992	$6,573,992	$74,865	$6,499,127	$0

No formal quantitative guidance provided. Management commentary indicated: “DoD revenue will be similar in the next quarter as we expect to finish the biocomparability study and [to] grow in the second half of the year as additional DoD‑supported studies are expected to be initiated.”

Metric	Period	Previous Guidance	Current Guidance	Change
DoD Revenue Trajectory	Q2 2018 / H2 2018	N/A	Q2: similar; H2: growth expected (additional DoD studies)	Maintained qualitative commentary

Topic	Q3 2017 (Prior Mentions)	Q4 2017 (Prior Mentions)	Q1 2018 (Current Period)	Trend
FDA pre‑EUA for entolimod	Module 3 manufacturing submitted; in‑vivo biocomparability study initiated; FDA review to resume post‑study	Pre‑EUA dossier review expected after study completion	Biocomparability analyses ongoing; FDA review aligned with EMA comparability focus	Steady progress pending study completion
EMA MAA for entolimod	EMA validation of MAA; significant milestone	EMA review underway; MAA filed; strategic priority	EMA Day 120 questions received; responses due by 9/14/2018; results from NHP biocomparability to inform response	Advancing through review milestones
Revenue mix (DoD vs Incuron)	Reduced JWMRP/manufacturing activity; lower revenue	Q4 revenue $0.87M; full‑year $1.95M	Revenue down to $0.23M; JWMRP/Incuron reductions quantified	Near‑term pressure; H2 uplift expected
Cost controls	G&A decreased; streamlining operations	G&A decreased YoY; continued cost reductions	R&D and G&A lower YoY; continued personnel/operating cost reductions	Maintaining discipline
Capital & runway	Cash & ST investments $10.1M at 9/30/17	$8.8M at 12/31/17; runway >12 months	$7.7M at 3/31/18; runway >12 months from filing	Adequate for near‑term plans

“The past quarter was one of important progress for the company and our Entolimod program. We continued our pursuit of a pre‑Emergency Use Authorization (pre‑EUA) with the FDA and a Marketing Authorization Application (MAA) with the EMA for entolimod as a medical radiation countermeasure.” — CEO Yakov Kogan
“Consistent with the FDA review of the company's pre‑EUA application, several of the EMA Day 120 review questions focused on the comparability between the entolimod formulation used in prior safety and efficacy studies and the formulation proposed for commercialization.” — CEO Yakov Kogan
“Filing of the MAA represents a significant milestone for the company and another major step toward making entolimod available worldwide as a life‑saving and practical treatment of acute radiation syndrome…” — CEO Yakov Kogan

No public earnings call transcript was available in our document set or discovery; management disclosures were via press releases and 10‑Q/8‑K filings .

Wall Street consensus EPS and revenue estimates via S&P Global were unavailable for STAB/CBLI for Q1 2018 due to missing CIQ mapping; thus, no beat/miss analysis versus consensus could be performed [GetEstimates error].

Near‑term revenue variability persists given grant/contract timing, with DoD program backlog substantial ($12.86M funded backlog) supporting H2 activity ramp potential .
Regulatory catalysts are central: EMA Day 120 response submission and FDA pre‑EUA review resumption post biocomparability study results could re‑rate the narrative .
Cash runway (>12 months) and continued cost discipline buffer execution risk, but commercialization remains the key unlock for equity value .
Non‑cash warrant valuation gains improved optics this quarter; underlying operating loss widened on lower revenue—watch mix and study initiations for normalization .
Absence of formal guidance and consensus estimates shifts focus to milestone delivery and DoD program starts; trading likely catalyst‑driven around EMA/FDA updates and contract execution .