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NexImmune, Inc. (NEXI)·Q1 2023 Earnings Summary

Executive Summary

  • Q1 2023 reflected disciplined expense management: R&D fell to $6.12M and G&A to $3.70M (vs $10.45M and $4.60M in Q1 2022), narrowing net loss to $9.57M and diluted EPS to $(0.37) .
  • Company reiterated cash runway “into the fourth quarter of 2023” with cash and equivalents of $22.3M at March 31, 2023; down from $34.6M at year-end .
  • Strategy remains centered on the “off-the-shelf” AIM INJ platform; pre-IND discussions initiated and NEXI-001 Phase 1 data slated for ASCO 2023, providing near-term scientific catalysts .
  • No consensus estimates available via S&P Global for NEXI; cannot assess beats/misses versus Street at this time due to missing vendor mapping.

What Went Well and What Went Wrong

What Went Well

  • Material operating discipline: R&D ($6.12M) and G&A ($3.70M) declined YoY, reducing quarterly net loss to $9.57M and EPS to $(0.37) .
  • Strategic progress: “initiated pre-IND discussions with the FDA for its first AIM INJ indication,” underscoring momentum toward clinical entry for the injectable platform .
  • Clinical/Scientific visibility: “NEXI-001 Phase I data to be presented at ASCO 2023 in June,” adding a near-term data readout catalyst .
    • CEO tone: “We remain focused on progressing the development of novel approaches…our AIM INJ direct injectable nanoparticle platform offers a unique and powerful solution…” .

What Went Wrong

  • Cash drawdown: cash and equivalents declined to $22.3M (Mar 31, 2023) from $34.6M (Dec 31, 2022), reflecting ongoing burn .
  • Programs paused: the company’s prior decision to pause AIM ACT clinical trials persists; Q1 commentary ties lower R&D to “completion of preclinical manufacturing work and the pausing of the clinical trials” .
  • No revenue base: the business remains pre-revenue (Q3 2022 reported “Revenue —”), leaving valuation dependent on R&D milestones and financing flexibility .

Financial Results

P&L and Cash (Quarterly Comparison: oldest → newest)

MetricQ3 2022Q4 2022Q1 2023
Net Loss ($USD Millions)$14.73 $16.90 $9.57
Diluted EPS ($USD)$(0.60) $(0.65) $(0.37)
R&D Expense ($USD Millions)$11.14 $13.70 $6.12
G&A Expense ($USD Millions)$3.72 $3.50 $3.70
Cash and Equivalents ($USD Millions)$45.86 (Sep 30, 2022) $34.64 (Dec 31, 2022) $22.32 (Mar 31, 2023)

Notes:

  • Revenue/margins: Company did not report revenue in Q3 2022 (“Revenue —”) and did not present revenue in Q4 2022/Q1 2023 press materials; margin metrics are not meaningful without revenue .
  • Shares Outstanding: 24.41M (Q3 2022), 26.08M (FY 2022 year-end), 26.08M (Q1 2023) .

KPI Breakdown

KPIQ3 2022Q4 2022Q1 2023
Basic/Diluted Shares Outstanding24,410,334 26,078,451 (as of 12/31/22) 26,078,451
Operating Expenses – Total ($USD Millions)$14.86 R&D $13.70; G&A $3.50 $9.83
Interest Income ($USD Millions)$0.227 $0.664 (FY) $0.275

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCorporate runway“through the third quarter of 2023” (Nov 2022) “into the fourth quarter of 2023” (Mar & May 2023) Raised
NEXI-001 Data TimingClinical readout“expected in the first quarter of 2023” (Nov 2022) “to be presented at ASCO 2023 in June” (May 2023) Updated timing
Strategic FocusPlatformRealignment to prioritize AIM INJ and pause AIM ACT trials (Nov 2022) Continued AIM INJ advancement; pre-IND discussions (Mar/May 2023) Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2: Q3 2022; Q-1: Q4 2022)Current Period (Q1 2023)Trend
AIM INJ focus & pre-INDStrategic realignment to AIM INJ; workforce reduction to extend runway “initiated pre-IND discussions” for first AIM INJ indication Execution progress toward IND
Clinical program status (NEXI-001/003)Pausing AIM ACT trials; NEXI-001 data expected Q1 2023 ASCO June 2023 presentation for NEXI-001 Phase 1 Visibility increased; timing clarified
Collaborations & researchNIH NINDS MS; NYU melanoma; BCMA bispecific poster Ongoing autoimmune work with Yale/JDRF; viral disease publication; multiple oncology studies Pipeline breadth sustained
Operating disciplineRealignment to reduce OpEx and extend runway through Q3 2023 R&D/G&A down YoY; runway into Q4 2023 Cost controls effective
Cash runwayThrough Q3 2023 (Nov 2022) Into Q4 2023 (Mar/May 2023) Slightly improved/maintained

Management Commentary

  • CEO (Q1 2023): “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 (Q1 2023): “We continue to move our INJ ‘off the shelf’ lead program forward in oncology and are encouraged by our conversations with the FDA.” .
  • CEO (Q4 2022): “We remain confident in the potential therapeutic benefit of our AIM platform-based products…we are focused on advancing our AIM INJ ‘off-the-shelf’ modality.” .
  • CEO (Q3 2022): “We have decided that the best path forward…is to realign internal resources to focus on advancing our AIM INJ ‘off-the-shelf’ platform.” .

Q&A Highlights

  • No Q1 2023 earnings call transcript was found; the company appears to have communicated results via press release/8-K rather than a published call transcript [SearchDocuments: none for earnings-call-transcript in Q2 2023 window].

Estimates Context

  • Wall Street consensus estimates (EPS/Revenue) via S&P Global were unavailable due to missing vendor mapping for NEXI; therefore, beats/misses versus Street cannot be assessed at this time (GetEstimates error: Missing CIQ mapping for ticker ‘NEXI’).

Key Takeaways for Investors

  • Expense discipline is evident and sustainable: R&D and G&A declined YoY, driving a smaller net loss and improved EPS in Q1 2023 .
  • Cash runway now targeted “into Q4 2023,” but with cash falling to $22.3M, financing or partnering remains a key medium-term consideration .
  • Scientific catalysts: NEXI-001 Phase 1 data at ASCO and expanding AIM INJ preclinical studies in oncology/autoimmune should shape the narrative and partnering interest .
  • Strategy is consistent: continued prioritization of AIM INJ injectable modality and pre-IND engagement supports a clearer path to clinical entry .
  • With no revenue base and paused ACT trials, stock moves will hinge on data quality, regulatory progress, and funding visibility—near-term trading likely event-driven around ASCO and any IND updates .
  • Monitor OpEx trajectory and cash burn closely; Q1 operating expenses were $9.83M, implying continued discipline is critical to extend runway without diluting shareholders .
  • Lack of available Street estimates reduces visibility on expectations; watch for sell-side coverage updates post-ASCO to recalibrate sentiment.

Sources: Q1 2023 press release and 8-K financials ; Q4 2022 press release ; Q3 2022 press release .