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HI

HUMANIGEN, INC (HGEN)·Q1 2022 Earnings Summary

Executive Summary

  • Q1 2022 loss narrowed sharply year over year as R&D spend fell with lower lenzilumab manufacturing costs; net loss was $21.3M ($0.32/share) vs $65.6M ($1.25/share) in Q1 2021, driven primarily by a $35.7M decline in manufacturing costs within R&D .
  • Cash and cash equivalents were $68.9M at Mar 31, 2022, with working capital essentially flat at ~$0.05M, underscoring liquidity tightness and reliance on external financing (ATM raised ~$18M net in Q1) .
  • Management completed enrollment in ACTIV-5/BET-B, aligned with FDA on the analysis plan, and targets Q2 topline data followed by an EUA amendment—key potential stock catalysts .
  • S&P Global consensus estimates for Q1 2022 revenue/EPS were not available via our connector; we attempted retrieval and no mapping existed for HGEN—thus no vs-consensus comparison this quarter (see Estimates Context) [GetEstimates attempt error].

What Went Well and What Went Wrong

What Went Well

  • Completed enrollment in NIH-sponsored ACTIV-5/BET-B (primary analysis population >400 patients) and aligned with FDA on the statistical analysis plan; plan to amend EUA after Q2 topline data. “A key highlight of the first quarter was the completion of enrollment ... we gained alignment on the data and statistical analysis plan ... anticipate top-line data ... with an amendment to our EUA submission planned to follow.” — CEO Cameron Durrant .
  • Year-over-year operating profile improved: R&D expense fell to $17.2M from $59.9M, driven primarily by $35.7M lower lenzilumab manufacturing costs, reducing the net loss to $21.3M from $65.6M .
  • Strategic positioning and market rationale reiterated: management argues hospitalizations will persist and positions LENZ as potentially complementary with remdesivir and variant-agnostic therapy in a sizable market, citing >$7B global sales for top hospital COVID treatments in 2021 .

What Went Wrong

  • Liquidity remains tight: working capital at 3/31/22 was ~$0.05M vs $2.25M at 12/31/21; despite $18M ATM proceeds, cash declined slightly to $68.9M from $70.0M, highlighting runway risk absent regulatory progress or further financing .
  • No revenue inflection: license revenue remained de minimis at ~$1.04M, similar to prior quarters, reflecting lack of commercialization pending regulatory authorizations .
  • Lack of a Q1 earnings call/Q&A limits visibility into timeline risk, burn/runway, and manufacturing readiness for potential EUA, especially following prior FDA refusal and earlier CMO challenges disclosed in late 2021 .

Financial Results

P&L and EPS (USD, $000s except per-share)

MetricQ3 2021Q4 2021Q1 2022
License revenue$1,036 $1,037 $1,036
Research & Development$60,811 $29,358 $17,220
General & Administrative$6,204 $4,024 $4,345
Loss from operations$(65,979) $(32,345) $(20,529)
Net loss$(66,739) $(33,540) $(21,278)
Net loss per share$(1.12) $(0.53) $(0.32)
Weighted avg shares59,486,626 63,136,915 65,590,724

Notes:

  • YoY (Q1’22 vs Q1’21): Net loss improved from $(65.6)M to $(21.3)M primarily due to manufacturing cost reduction in R&D .
  • QoQ (Q1’22 vs Q4’21): Continued sequential reduction in losses as R&D fell further .

Liquidity and Working Capital (USD, $000s)

MetricSep 30, 2021Dec 31, 2021Mar 31, 2022
Cash & cash equivalents$76,500 $70,016 $68,948
Current assets$77,847 $70,971 $71,235
Current liabilities$68,709 $68,725 $71,181
Working capital$9,138 $2,246 $54

KPIs and Program Milestones

  • ACTIV-5/BET-B status: ~75% enrolled (Q3’21) → Enrollment completed (FY’21 year-end highlights) → Primary analysis population >400 patients, topline expected in Q2’22 .
  • Capital markets: ~$18M net raised via ATM in Q1’22 .

Estimates vs Actuals

  • S&P Global consensus for Q1 2022 revenue and EPS was unavailable via our connector; no comparison to estimates is provided this quarter (see Estimates Context). [GetEstimates attempt error]

Segment Breakdown

  • Not applicable; Humanigen is a clinical-stage company without reportable commercial segments during the period .

Guidance Changes

Metric/ItemPeriodPrevious Guidance (as of FY2021 release)Current (Q1 2022)Change
ACTIV-5/BET-B topline timing1H 2022“Late Q1 or early Q2” for topline in CRP<150 mg/L cohort “Top-line data ... to be reported in the second quarter” Slightly later; narrowed to Q2
EUA path (US)2022If ACTIV-5/BET-B successful in CRP<150 mg/L, plan to submit amended EUA Plan to file EUA amendment after Q2 topline; alignment reached on data/SAP Maintained; process clarified
SHIELD (CAR-T toxicity) initiation2022Initiate Phase 3 SHIELD in 1H 2022 Intend to enroll first patient in Q2 Timing reaffirmed/narrowed
RATinG (aGvHD) start2022Plan to enroll first patient in H1 2022 “First patient will be enrolled in the second quarter” Timing reaffirmed
Commercial access (EU/UK)2022Commence LenzMAP shipments in UK/EU where allowed Not updated in Q1 release No update

Earnings Call Themes & Trends

TopicQ3 2021 (Nov-21)Q4 2021 (Feb-22)Q1 2022 (May-22)Trend
Regulatory (EUA/MHRA/EMA)FDA declined EUA; pursuing MHRA CMA and EU options Plan to amend EUA upon successful ACTIV-5; progressing UK/EU filings Alignment with FDA on data/SAP; plan to amend EUA post-Q2 topline Incremental progress toward resubmission
ACTIV-5/BET-B~75% enrolled Enrollment completed (highlighted) Topline in Q2; primary analysis >400 pts From enrolling → data pending
Manufacturing/CMO executionHigh mfg costs; batch/spec issues at some CMOs Elevated costs in 2021 R&D down YoY as mfg costs fell Cost tapering; execution risk persists
LiquidityCash $76.5M; ATM proceeds post-quarter Cash $70.0M YE21 Cash $68.9M; working capital ~$0.05M; raised $18M ATM Liquidity tightening
Pipeline beyond COVIDCMML, aGvHD, CAR-T program planning Plans for SHIELD, RATinG, C-SMART SHIELD Q2 start; RATinG Q2 start; CMML ongoing Pipeline execution slated for Q2

Management Commentary

  • “A key highlight of the first quarter was the completion of enrollment in the ACTIV-5/BET-B study. We also held a productive Type B pre-EUA meeting with FDA ... We anticipate top-line data ... in the second quarter, with an amendment to our EUA submission planned to follow.” — Cameron Durrant, CEO .
  • “We anticipate hospitalizations from COVID-19 will continue for years to come... supports treatment guidance based on CRP levels and first-line utilization in hypoxic patients.” — Cameron Durrant .
  • “LENZ could deliver significant economic savings ... can be used in combination with remdesivir ... Sales of the top two hospital treatments for COVID-19 exceeded $7 billion in global revenue in 2021. We believe LENZ is well positioned to participate in this sizable and sustainable market.” — Edward Jordan, CCO .

Q&A Highlights

  • No Q1 2022 earnings call transcript was located in the company’s filings set; management commentary was provided via the press release .

Estimates Context

  • We attempted to retrieve S&P Global consensus for Q1 2022 (revenue and EPS), but mapping for HGEN was unavailable in our connector; therefore no vs-consensus comparison is provided this quarter. If/when S&P Global mapping is restored, we will update this section with consensus and surprise analysis [GetEstimates attempt error].

Key Takeaways for Investors

  • Binary regulatory catalyst: ACTIV-5/BET-B topline in Q2 followed by potential EUA amendment represents the near-term stock driver; outcome and FDA feedback are pivotal .
  • Improved P&L trajectory: Sharp YoY reduction in R&D from lower manufacturing costs narrowed the net loss; if sustained, burn moderates, but commercialization remains prerequisite for durable improvement .
  • Liquidity is tight: Working capital near breakeven and modest cash decline despite ATM raises highlight dependence on external capital and/or regulatory progress to extend runway .
  • Execution watchpoints: Prior CMO/mfg issues (2021) and the need to scale if authorized remain risks; investors should gauge manufacturing readiness and supply chain plans on upcoming updates .
  • Pipeline breadth provides optionality: CAR-T toxicity (SHIELD) and aGvHD (RATinG) are advancing toward initiation, offering non-COVID value drivers if timelines hold .
  • Market rationale persists: Management argues ongoing COVID hospitalizations and variant-agnostic need support LENZ’s potential role, particularly with CRP-guided patient selection and combination with remdesivir .
  • Trading setup: Stock is likely highly sensitive to Q2 data readout timing/strength and any FDA signals on the EUA amendment path; absence of consensus data adds uncertainty to expectations this quarter .