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ProMIS Neurosciences Inc. (PMN)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 was execution-focused: PRECISE-AD enrollment surpassed 50% with no ARIA or dropouts; FDA granted Fast Track to PMN310; and the DSMB later cleared escalation to the final 20 mg/kg cohort, keeping interim/topline timelines intact .
  • Operating expenses rose sharply on trial spend (R&D $8.75M vs. $1.63M YoY), driving a net loss of $10.12M and EPS of $(0.29), below S&P Global consensus EPS of $(0.18)*; revenue remained at zero as expected for a clinical-stage company .
  • Liquidity improved after quarter-end: the company raised ~$21.6M gross via a mix of registered direct, PIPE, warrant exercises and reactivated its ATM facility with a new agent; quarter-end cash was $4.51M .
  • Near-term stock catalysts: continued ARIA-free safety updates, cohort-3 dosing progress, Fast Track interactions with FDA, and disciplined use of new financings/ATM to fund the 2026 interim/topline milestones .

What Went Well and What Went Wrong

  • What Went Well

    • PMN310 momentum: “enrollment in the PRECISE-AD Phase 1b Alzheimer’s disease trial has surpassed 50%... no cases of ARIA… and no patient dropouts,” with FDA Fast Track designation secured .
    • Safety/timeline intact: DSMB recommended escalation to the third/final cohort; interim 2Q26 and topline 4Q26 reiterated; no ARIA observed to date .
    • Funding access: ~$21.6M gross proceeds in July across multiple transactions; new ATM agreement established, expanding financing optionality .
  • What Went Wrong

    • Expense intensity: R&D spend increased to $8.75M vs. $1.63M YoY as Phase 1b scaled, pressuring operating loss and EPS .
    • Wider loss vs. expectations: Net loss $(10.12)M and EPS $(0.29) missed consensus EPS of $(0.18)*; revenue remains zero (biotech norm) .
    • Continued Nasdaq bid-price non-compliance (extension granted to Dec 29, 2025), with potential reverse split consideration if needed .

Financial Results

Financial summary (oldest → newest):

MetricQ2 2024Q1 2025Q2 2025
R&D Expense ($M)$1.63 $5.46 $8.75
G&A Expense ($M)$1.09 $2.00 $1.43
Total Operating Expenses ($M)$2.71 $7.46 $10.18
Net Loss ($M)$(2.62) $(7.35) $(10.12)
EPS (Basic/Diluted)$(0.13) $(0.21) $(0.29)
Cash & Equivalents (Period End, $M)n/a$8.36 $4.51

Results vs. S&P Global consensus (Q2 2025):

MetricActualConsensus
EPS$(0.29) $(0.18)*
Revenue ($M)$0.0 (no revenue recognized; not presented as a line item) $0.0*

Values marked with * are from S&P Global estimates.

KPI and operating highlights (Q2 2025 and subsequent):

  • PRECISE-AD enrollment >50% of 128 patients; no ARIA; no dropouts .
  • FDA Fast Track for PMN310 (July 2025) .
  • DSMB clearance to final 20 mg/kg cohort; still on track for 2Q26 interim and 4Q26 topline .
  • Post-quarter financing ~$21.6M gross; reactivated ATM with new agent .

No segments reported.

Guidance Changes

Metric/ItemPeriodPrevious GuidanceCurrent GuidanceChange
PRECISE-AD 6-month interim (biomarkers/safety)2Q 20261H 2026 (Q1/FY24/Q1’25 communications) 2Q 2026Maintained
PRECISE-AD 12-month topline (incl. clinical outcomes)4Q 2026By end of 2026 4Q 2026Maintained
FDA regulatory status (PMN310)n/an/aFast Track designation granted (July 2025)New positive milestone
Dosing escalation2025Progress per DSMBProceed to final 20 mg/kg cohortPositive (DSMB)

Earnings Call Themes & Trends

(No Q2 2025 earnings call transcript was available.) Themes compiled from FY24/Q1/Q2 releases and DSMB update.

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q2 2025)Trend
R&D execution & enrollmentPhase 1b initiated; cohort-1 completed; enrollment progressing faster than expected >50% enrolled; no ARIA; DSMB cleared final cohortImproving execution
Safety (ARIA)Emphasis on avoiding plaque to reduce ARIA risk No ARIA observed to date; no dropouts Positive confirmation
Biomarkers strategyEarly focus on plasma/CSF biomarkers to power early readouts Detailed biomarker panel (pTau217/pTau243, NfL, GFAP, Aβ42/40, SNAP25, neurogranin) More specificity
Regulatory statusn/a (Fast Track not yet granted in FY24/Q1) FDA Fast Track grantedPositive milestone
Financing/liquidityUp to $122.3M in 2024 PIPE structure; YE24 cash $13.3M ~$21.6M gross in July 2025; new ATM established Funding optionality maintained
Nasdaq listingn/a in FY24/Q1Additional 180-day extension to 12/29/25; reverse split considered if neededMonitoring

Management Commentary

  • “As of August 12, enrollment in the PRECISE-AD Phase 1b Alzheimer’s disease trial has surpassed 50%... no cases of ARIA… no patient dropouts… reinforcing PMN310’s potential favorable safety profile.” — Neil Warma, CEO .
  • “Our recent FDA Fast Track designation for PMN310 underscores the urgent need for safer, more effective Alzheimer’s treatments.” — Neil Warma, CEO .
  • “PRECISE-AD will be the first study to examine the effects of a monoclonal antibody directed solely against AβO on biomarkers associated with AD pathology and clinical outcomes… [with] 95% confidence for detection of ARIA.” .

Q&A Highlights

  • No Q2 2025 earnings call transcript or Q&A session was found. The quarter’s narrative was communicated via the earnings press release and subsequent DSMB update .

Estimates Context

  • S&P Global consensus for Q2 2025 EPS was $(0.18); PMN reported $(0.29), a wider loss (miss). Revenue consensus was $0.0, consistent with actual zero revenue recognition .
  • Estimate implications: expense cadence for Phase 1b is running higher as cohorts progress; unless offset by other income, EPS may remain below prior expectations near-term. Values retrieved from S&P Global.

Key Takeaways for Investors

  • Clinical de-risking: No ARIA, no dropouts and DSMB clearance to final cohort, plus FDA Fast Track, collectively strengthen PMN310’s safety/regulatory narrative ahead of 2026 readouts .
  • Expense ramp is the design: R&D step-up reflects trial scaling; expect continued expense intensity through cohort-3 and 2026 milestones .
  • Liquidity flexibility: ~$21.6M gross raised post-quarter and reactivated ATM with a new agent provide multiple levers to fund ongoing execution; monitor dilution cadence and ATM usage .
  • Timeline maintained: Interim (2Q26) and topline (4Q26) maintained; any additional ARIA-free safety updates or faster enrollment could incrementally de-risk the program .
  • Listing overhang: Nasdaq minimum bid-price remediation remains a 2H25 governance item (extension to Dec 29, 2025); a reverse split remains a potential tool if needed .
  • Catalyst path: Near-term safety/enrollment updates, biomarker methodology presentations, and any business development or financing terms are likely stock movers into 2026 .

Values marked with * are from S&P Global estimates.