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NexImmune, Inc. (NEXI)·Q2 2023 Earnings Summary

Executive Summary

  • NexImmune’s Q2 2023 focused on strategic pivot to AIM injectable (AIM INJ) modality and preclinical progress while reducing operating expenses; GAAP net loss improved to $7.57M ($0.29 per share) from $15.86M ($0.69) YoY on lower R&D and G&A .
  • Cash and cash equivalents declined to $16.28M at June 30, 2023; management reiterated runway into Q4 2023, highlighting the need for near-term financing or partnership catalysts .
  • Operational guidance emphasized IND preparation for NEXI-101 (injectable) in 2H 2024 and ongoing preclinical/mfg transfer work; no product revenue or financial guidance ranges were provided .
  • No Q2 2023 earnings call transcript was available in our document corpus; comparison to Wall Street consensus was not possible given missing S&P Global mapping for NEXI (consensus unavailable) .

What Went Well and What Went Wrong

What Went Well

  • Management executed strategic prioritization toward AIM INJ with supportive preclinical data across oncology and autoimmune indications; “We remain excited about advancing the injectable programs to the clinic and we are encouraged by initial dialogue with the FDA” — CEO Kristi Jones .
  • R&D expenses fell to $4.88M vs $11.84M YoY and G&A to $2.90M vs $4.09M YoY, reflecting completion of preclinical mfg work, pausing of clinical trials, and personnel reductions .
  • NEXI-001 Phase 1 data showed favorable safety and durable response; one Cohort 3 AML patient remains asymptomatic with no evidence of disease at nine months post-treatment, supporting platform validation .

What Went Wrong

  • Cash balance decreased to $16.28M from $34.64M at year-end; runway only into Q4 2023 indicates heightened near-term financing risk .
  • Clinical programs remain paused as resources are reallocated to AIM INJ, limiting near-term clinical catalysts from adoptive cell therapy trials .
  • No product revenue and continued GAAP net losses ($7.57M in Q2) underline the pre-commercial risk profile and dependence on external milestones .

Financial Results

Quarterly P&L and Cash Metrics

MetricQ4 2022Q1 2023Q2 2023
Net Loss ($USD Millions)$16.9 $9.57 $7.57
EPS (Basic & Diluted, $USD)$(0.65) $(0.37) $(0.29)
R&D Expense ($USD Millions)$13.7 $6.12 $4.88
G&A Expense ($USD Millions)$3.5 $3.70 $2.90
Total Operating Expenses ($USD Millions)N/A$9.83 $7.78
Cash & Cash Equivalents (Period-End, $USD Millions)$34.64 $22.32 $16.28

Notes:

  • The company did not report revenue or gross margin metrics in the provided quarterly materials; statements of operations list operating expenses and net loss without revenue line items .

Q2 2023 YoY Comparisons (as disclosed)

MetricQ2 2022Q2 2023
R&D Expense ($USD Millions)$11.84 $4.88
G&A Expense ($USD Millions)$4.09 $2.90
Net Loss ($USD Millions)$15.86 $7.57
EPS (Basic & Diluted, $USD)$(0.69) $(0.29)

Segment Breakdown

  • Not applicable; no segments disclosed in the press releases .

KPIs

KPIQ4 2022Q1 2023Q2 2023
Cash runway commentaryInto Q4 2023 Into Q4 2023 Into Q4 2023
IND timing (injectable)Pre-IND discussions initiated Pre-IND discussions with FDA IND for NEXI-101 planned 2H 2024

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runway2023Fund ops into Q4 2023 Fund ops into Q4 2023 Maintained
NEXI-101 (AIM INJ) IND submission2024Pre-IND discussions Submit IND in 2H 2024; mfg components produced; CDMO transfer underway Raised specificity/timing
Clinical programs (ACT cell therapy)2023Paused; exploring external opportunities Continuing pause; focus on injectable program Maintained
Revenue/EPS guidance2023Not provided Not provided Maintained

Earnings Call Themes & Trends

Note: No Q2 2023 earnings call transcript available in our corpus; themes compiled from press releases across quarters .

TopicPrevious Mentions (Q4 2022, Q1 2023)Current Period (Q2 2023)Trend
AIM INJ strategic focusPivot to AIM INJ; preclinical studies; pre-IND with FDA Explicit prioritization of AIM INJ; advancing to clinic; initial FDA dialogue Strengthening
Oncology combo approachesAIM-expanded T cells + bispecifics show superior potency/persistence (MM models) Synergistic tumor killing at low doses with TCEs + AIM T cells Strengthening
Autoimmune programsT1D, MS collaborations (Yale/JDRF, NIH) EBV MS functional validation; T1D in vivo delay; Class II approach for RA/celiac Broadening
NEXI-001 AML (post allo-HSCT)Completed final safety cohort; plan to share data mid-2023 Favorable safety; patient with durable response up to nine months Positive clinical signal
Manufacturing/RegulatoryBuilding IND engine; resource realignment Preparing clinical material; CDMO transfer for injectable; polymer vendor selected Operational progress
Cash and runway$34.6M YE cash; runway into Q4 2023 $16.28M cash; runway into Q4 2023 Deteriorating liquidity

Management Commentary

  • “Our previously announced strategic prioritization of our injectable modality (AIM INJ) underscores our commitment to delivering on the significant potential of our artificial antigen-presenting cell (aAPC) nanoparticles...” — CEO Kristi Jones .
  • “Our cells exhibit potential superior potency and durability in preclinical models, combining a low dose of AIM multi-tumor expanded T cells with low doses of T-cell engaging bispecific agents, and showing synergistic tumor killing.” — CEO Kristi Jones .
  • “We remain excited about advancing the injectable programs to the clinic and we are encouraged by initial dialogue with the FDA.” — CEO Kristi Jones .
  • Q1 setup: “We believe our AIM INJ direct injectable nanoparticle platform offers a unique and powerful solution to direct a multi-antigen specific T cell response in a scalable ‘off the shelf’ approach.” — CEO Kristi Jones .

Q&A Highlights

  • No Q2 2023 earnings call transcript available in our document corpus; thus Q&A highlights and any call-based guidance clarifications are unavailable .

Estimates Context

  • Wall Street consensus (S&P Global) for NEXI Q2 2023 was unavailable due to missing CIQ mapping for NEXI; therefore, comparison to estimates cannot be provided. If you need estimates comparisons, we can attempt alternative data sources or update the mapping to retrieve S&P Global consensus .

Key Takeaways for Investors

  • Liquidity is the key near-term risk: cash fell to $16.28M with runway only into Q4 2023, implying urgency for capital or partnerships to bridge to 2H 2024 IND milestone .
  • Expense discipline is evident: R&D and G&A declines drove net loss improvement; the company is executing on a leaner model aligned to AIM INJ priorities .
  • Platform validation continues: durable AML response and cross-modality preclinical data support AIM mechanism, with potential in oncology and autoimmune indications .
  • Regulatory/mfg steps are progressing: clinical protein production complete; CDMO transfer underway; IND for NEXI-101 targeted for 2H 2024, a potential catalyst if timelines hold .
  • Lack of revenue and continued GAAP losses underscore binary event dependency; absent a call transcript and consensus estimates, the narrative hinges on preclinical updates and IND progress .
  • Trading lens: watch for financing announcements, partnership news, and IND acceptance; any delay in the IND timeline or unexpected cost uptick could pressure shares, while partnership validation in oncology/autoimmune could re-rate risk .