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ProMIS Neurosciences Inc. (PMN)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 reflected accelerated clinical execution and higher R&D spend: PRECISE-AD (PMN310) was >85% enrolled with Cohorts 1 and 2 complete and Cohort 3 underway; DSMB cleared escalation to final cohort with no ARIA observed to date through Cohort 2, and interim/top-line timing reiterated (Q2 2026/Q4 2026) .
  • EPS of $(0.24) beat S&P Global consensus of $(0.29) by ~$0.05 on lower-than-feared other expense; revenue remains $0 as a pre-revenue biotech (consensus revenue $0) . EPS consensus values from S&P Global*.
  • Cash rose to $15.4M (9/30) after July financings totaling ~$21.6M gross; however, management disclosed substantial doubt about going-concern sufficiency with cash not funding 12 months absent additional capital .
  • Key 2026 catalysts unchanged: 6‑month blinded interim biomarker/safety readout in Q2 2026; 12‑month top-line in Q4 2026. Near-term 2025 catalysts include completion of PRECISE-AD enrollment and continued safety updates (ARIA) .

What Went Well and What Went Wrong

What Went Well

  • PRECISE-AD momentum and safety: “over 85% enrolled… complete enrollment expected before the end of the year,” and “continues to demonstrate a favorable safety profile” with DSMB clearing final dose escalation; no ARIA observed through Cohort 2 .
  • Regulatory positioning: FDA Fast Track for PMN310 in July 2025, supporting expedited interaction and potential review benefits .
  • Strengthened balance sheet: ~$21.6M gross proceeds across July discounted warrant exercises, private placements and a registered direct offering, driving quarter-end cash to $15.4M .

Management quotes:

  • “2025 has been a year of intense focus and successful execution… preparing the Company for its multiple key anticipated inflection points in 2026” — CEO Neil Warma .
  • “The DSMB’s recommendation… keeps us firmly on track toward our planned interim and top-line data readouts in 2026” — CEO Neil Warma .
  • “The safety profile observed with PMN310 to date is encouraging and consistent with its design as a highly selective antibody targeting toxic oligomers” — CMO Larry Altstiel, M.D., Ph.D. .

What Went Wrong

  • Elevated cash burn and OpEx: R&D rose to $9.8M in Q3 (vs. $2.6M YoY) as Phase 1b spending ramped; loss from operations widened to $11.8M .
  • Liquidity/going concern: Management stated cash of $15.4M is not sufficient to fund ≥12 months; substantial doubt exists absent new financing .
  • Controls: A material weakness persisted in internal control over financial reporting related to review controls for certain fair value measurements (warrants) .

Financial Results

P&L snapshot vs prior periods

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Research & Development ($M)$2.564 $5.464 $8.750 $9.797
General & Administrative ($M)$1.871 $1.996 $1.435 $1.953
Total Operating Expenses ($M)$4.435 $7.460 $10.185 $11.750
Loss from Operations ($M)$(4.435) $(7.460) $(10.185) $(11.750)
Other Income (Expense), net ($M)$13.711 $0.112 $0.068 $0.170
Net (Loss) Income ($M)$9.276 $(7.348) $(10.117) $(11.580)
Diluted EPS ($)$0.31 $(0.21) $(0.29) $(0.24)

Notes: Q3 2024 profitability was driven by non-cash gains related to fair value changes of financial instruments; this tailwind was absent in 2025 .

Liquidity and capitalization

MetricQ1 2025Q2 2025Q3 2025
Cash & Cash Equivalents ($M)$8.364 $4.510 $15.399
Working Capital ($M)——~$9.2
Shareholders’ Equity ($M)$9.472 $(0.383) $9.187

Drivers: ~$21.6M gross proceeds in July 2025 across discounted warrant exercises, new warrants and a registered direct offering; 1.02M ATM shares also sold in Q3 for ~$0.71M net .

EPS vs S&P Global consensus

MetricQ1 2025Q2 2025Q3 2025
EPS Actual ($)$(0.21) $(0.29) $(0.24)
EPS Consensus Mean ($)$(0.12)*$(0.18)*$(0.29)*
Beat (Miss) ($)$(0.09)$(0.11)+$0.05

Estimates disclaimer: *Values retrieved from S&P Global.

Operating model context (pre-revenue)

MetricQ1 2025Q2 2025Q3 2025
Revenue ($M)$0 (pre-revenue) $0 (pre-revenue) $0 (pre-revenue)

Segment reporting: Single operating segment (life science) .

KPIs (clinical and regulatory)

KPIQ1 2025Q2 2025Q3 2025
PRECISE-AD Enrollment StatusCohort 1 completed; dosing underway >50% of planned 128 enrolled; no dropouts >85% enrolled; Cohorts 1–2 complete; Cohort 3 underway; full enrollment targeted YE25
ARIA Safety—No ARIA observed to date No ARIA observed through Cohort 2; favorable safety profile reiterated
Planned Enrollment (N)—128 128
FDA Fast Track (PMN310)—Granted July 2025 Fast Track referenced
Interim/Top-line TimingH1 2026 / YE 2026 Q2 2026 / Q4 2026 Q2 2026 / Q4 2026 (on track)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
PRECISE-AD 6‑mo interim readout2026H1 2026 (Q1 press) Q2 2026 (Q2/Q3 reiteration) Narrowed to Q2; reaffirmed
PRECISE-AD 12‑mo top-line2026By end of 2026 Q4 2026 (Q2/Q3 reiteration) Narrowed to Q4; reaffirmed
Enrollment completion2025>50% as of Aug 12 (no timeline set) “Complete before year-end 2025” New explicit target
Safety (ARIA)OngoingNo ARIA observed to date (Q2) No ARIA observed through Cohort 2; DSMB cleared final cohort Improved dataset; positive continuation

No financial guidance provided (revenue/EPS); company remains pre-revenue and highlighted going-concern risk without new financing .

Earnings Call Themes & Trends

Note: No earnings call transcript was filed; themes below reflect disclosures across Q1–Q3 earnings materials and related press releases.

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
Enrollment & ARIA safetyCohort 1 complete; >50% enrolled; no ARIA; no dropouts >85% enrolled; Cohorts 1–2 complete; no ARIA through Cohort 2; DSMB greenlight for final cohort Improving (recruitment/safety)
FDA interactionsFast Track granted in July Fast Track reiterated Stable (positive)
Biomarker strategyEarly biomarker emphasis; AAIC/AAN data Reiterated biomarker panel and interim analysis focus Stable
Liquidity/runwayCash $8.4M (Q1), $4.5M (Q2); July raises planned Cash $15.4M (9/30) after ~$21.6M gross, but going-concern doubt remains Mixed (cash up, risk persists)
Internal controls——Material weakness persists (fair value controls)

Management Commentary

  • Strategic focus and 2026 inflection points: “We have reinforced the Company’s strong foundation… preparing the Company for its multiple key anticipated inflection points in 2026” — Neil Warma, CEO .
  • DSMB and safety: “The DSMB’s recommendation to proceed… keeps us firmly on track… interim and top-line data readouts in 2026” — Neil Warma, CEO .
  • Differentiation on ARIA and target selection: “The safety profile observed with PMN310 to date is encouraging and consistent with its design as a highly selective antibody targeting toxic oligomers” — Larry Altstiel, M.D., Ph.D., CMO .

Q&A Highlights

  • No Q&A was disclosed in the company’s Q3 earnings materials; key investor focus areas addressed in disclosures: enrollment pace and ARIA safety (no ARIA through Cohort 2), DSMB clearance to final cohort, and confirmation of interim/top-line timing .

Estimates Context

  • Q3 EPS of $(0.24) beat S&P Global consensus of $(0.29) by ~$0.05; revenue remains $0 vs. $0 consensus as a pre-revenue company . EPS consensus values from S&P Global*.
  • Earlier quarters tracked below consensus as trial spending ramped: Q1 actual $(0.21) vs $(0.12) consensus; Q2 actual $(0.29) vs $(0.18) consensus. EPS consensus values from S&P Global*.
  • Target price consensus mean referenced at ~$5.34; Consensus recommendation text not available in our pull. Values from S&P Global*.

Estimates disclaimer: *Values retrieved from S&P Global.

Key Takeaways for Investors

  • Clinical execution is the core driver: Enrollment is nearing completion with continued clean ARIA safety; DSMB clearance reduces development-risk perception heading into 2026 biomarker readouts .
  • Near-term catalysts: full PRECISE-AD enrollment by YE25; ongoing safety updates; any biomarker poster/presentation flow — all potential stock movers given the differentiated non-plaque binder profile .
  • Balance sheet improved, but financing overhang remains: Despite $15.4M cash at Q3 and July raises, management disclosed substantial doubt about 12‑month funding; expect continued capital markets engagement and potential dilution/overhang from large warrant stack .
  • Controls and execution risk: Material weakness in ICFR persists; remediation progress should be monitored alongside clinical operations growth .
  • 2026 is the pivotal year: Q2 2026 interim (biomarkers/safety) and Q4 2026 top-line (incl. clinical measures) will critically inform PMN310’s efficacy/safety profile relative to plaque-binders and could reset the equity narrative .
  • Position sizing should reflect binary biotech risk: Pre‑revenue, single-asset concentration, financing needs, and clinical development uncertainties remain the primary risk factors .