PN
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):
Results vs. S&P Global consensus (Q2 2025):
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
Earnings Call Themes & Trends
(No Q2 2025 earnings call transcript was available.) Themes compiled from FY24/Q1/Q2 releases and DSMB update.
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.