Below is a focused summary of enGene Holdings Inc. based solely on the information provided.

Company snapshot

• Name: enGene Holdings Inc.
• Public listing: Nasdaq (Common Shares: ENGN; Warrants: ENGNW). Common Shares and Warrants began trading November 1, 2023.
• Corporate headquarters: 4868 Rue Levy, Suite 220, Saint‑Laurent (Montréal), QC H4R 2P1, Canada. U.S. offices: Boston, MA and Waltham, MA.
• Auditor: KPMG LLP (Montréal, Canada).
• Corporate history: Formed as 14963148 Canada Inc. (April 24, 2023); changed name to enGene Holdings Inc. (May 9, 2023). Completed reverse recapitalization / business combination with FEAC on October 31, 2023.
• Shares outstanding (reported): 66,984,661 Common Shares as of December 17, 2025.
• Aggregate market value of common equity held by non‑affiliates: $154,176,366 (based on Nasdaq close, April 30, 2025).

What the company does (core business and technology)

• enGene is a clinical‑stage biotechnology company developing non‑viral genetic medicines targeted to mucosal tissues and other organs.
• Proprietary delivery technology: Dually Derived Chitosan (DDX) gene‑delivery platform — a proprietary, chemically‑derived short‑chain chitosan carrier that forms nanoparticles with genetic cargo. DDX is intended to enable localized delivery, repeat dosing and payload flexibility (DNA/RNA, multiple cargos).
• Lead product candidate: detalimogene voraplasmid (formerly EG‑70).
  • Product composition: small plasmid DNA that encodes three cargos (single‑chain IL‑12 and two non‑coding RNAs eRNA11a and VA1 that activate RIG‑I), encapsulated in DDX nanoparticles and coated with PEG‑b‑PLE; formulated as an aqueous nanoparticle dispersion then lyophilized. Stored at –20°C.
  • Mechanism (as described): local transfection of urothelial/mucosal epithelial tissue → coordinated RIG‑I activation (innate immunity) + IL‑12 expression (adaptive/T cell activation) → pro‑inflammatory, anti‑tumor microenvironment without genomic integration.
  • Intended clinical application (primary focus): monotherapy for non‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) that is Bacillus Calmette‑Guérin (BCG)‑unresponsive (with or without concomitant papillary disease). Company is also studying BCG‑naïve and BCG‑exposed CIS and papillary‑only NMIBC populations.
  • Regulatory designations and programs: FDA Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations; LEGEND trial selected for FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program.
  • Planned regulatory milestone: Company planned to file a Biologics License Application (BLA) in second half of 2026 for U.S. approval as monotherapy in BCG‑unresponsive NMIBC with CIS (subject to supportive data).

Clinical development (LEGEND trial)

• LEGEND = combined Phase 1/2 open‑label clinical trial (ClinicalTrials.gov NCT04752722).
• Phase 1:
  • Enrolled: 24 patients (all received ≥1 dose). Primary objective: safety/tolerability and dose selection.
  • Safety: Majority of treatment‑related adverse events (TRAEs) Grade 1–2 (75%); one Grade 3 TRAE (patient had pre‑existing renal issues); no dose‑related increase in AE severity observed.
  • Efficacy (exploratory): 22 patients evaluable for 3‑month assessment; CR at any time 73%; 3‑month CR 68%; 6‑month CR 45% across all doses. At the dose selected for pivotal Phase 2, 3‑month CR 70% and 6‑month CR 60% (90% continued treatment beyond 3 months).
• Phase 2 (pivotal + additional cohorts):
  • Cohort 1 (pivotal): BCG‑unresponsive NMIBC with CIS — enrollment completed with 125 patients (safety population assessed as of Oct 24, 2025).
  • Cohort 2a: BCG‑naïve NMIBC with CIS — 30 patients enrolled (as of Nov 11, 2025).
  • Cohort 2b: BCG‑exposed NMIBC with CIS — 45 patients enrolled (as of Nov 11, 2025).
  • Cohort 3: BCG‑unresponsive papillary‑only NMIBC — 36 patients enrolled (as of Nov 11, 2025).
  • Protocol amendment (Q4 2024): changed evaluation and treatment rules (e.g., TURBT requirements for T1 disease, biopsy confirmation rules at certain timepoints). Company reported separate efficacy summaries pre‑ and post‑protocol amendment.
• Selected preliminary efficacy updates:
  • Early Phase 2 update (data cut‑off Sept 13, 2024; 21 patients): CR at any time 71% (15/21); 3‑month CR 67% (14/21); 6‑month CR 47% (8/17); Kaplan‑Meier estimate for 6‑month CR 51%. Safety generally favorable (no drug‑related discontinuations in that early dataset).
  • Updated preliminary results (data cut‑off Oct 24, 2025): Company separated ITT patients into Pre‑Protocol Amendment (31 patients) and Post‑Protocol Amendment (62 patients) subpopulations (enrollment details described above). Among Post‑Protocol Amendment patients, 62% remained in CR at 6 months; all evaluable patients at 9 months were reported to have continued CR (company‑provided update).
• Safety (Cohort 1, as of Oct 24, 2025): 125 patients assessed; 42% experienced ≥1 TRAE (mainly Grade 1–2); 3 patients (2.4%) had Grade 3 TRAEs; no Grade 4 or 5 TRAEs reported in preliminary update. Most common TRAEs: dysuria (21.4%), bladder spasm (19%), pollakiuria (11.9%), fatigue (11.9%).

Manufacturing and supply

• enGene does not own clinical or commercial manufacturing facilities and relies on contract manufacturing organizations (CMOs). Company states processes are cGMP‑compliant and scalable to commercial launch levels it believes will meet U.S. commercial needs, and DDX and PEG‑b‑PLE are novel excipients. Drug product is lyophilized and stored at −20°C.
• Company developed DDX platform and manufacturing processes in‑house, then transferred to qualified external CMOs for clinical supply; company plans long‑term commercial supply agreements if approved.
• Company holds a global, royalty‑bearing, non‑exclusive license to certain Nanoplasmid™ plasmid backbone intellectual property (see Licensing below).

Intellectual property and licenses

• Patent portfolio (company disclosures): approximately 11 patent families; ~135 issued patents and ~64 pending patent applications worldwide (includes 13 issued U.S. patents and multiple foreign grants and pendings). Patent expirations vary across families (company lists expirations spanning ~2027 through mid‑2040s depending on family and patent‑term adjustments).
• Notable IP coverage claims: composition‑of‑matter and method claims covering DDX derivatization chemistry, non‑covalent reversible nanoparticle coating (PEG‑b‑PLE), combination of IL‑12 + RIG‑I agonists, manufacturing methods, and indications (lung, gut, bladder, metastatic cancers).
• Strategic license (NTC / Nanoplasmid):
  • enGene holds a worldwide, non‑exclusive, royalty‑bearing, sublicensable license from Nature Technology Corporation (NTC; subsequently acquired by Aldevron) covering Nanoplasmid vector backbone patents and know‑how for gene and cell therapy products (non‑dermatology field excluded).
  • Key payments/terms disclosed: annual $50,000 payments until first sale (first‑dose milestone payment of $50,000 achieved in 2021), $450,000 milestone upon regulatory approval (not yet achieved), low single‑digit royalties on net product sales, per‑gram manufacturing payments for GMP lots (until product approval in the country). NTC remains responsible for prosecution of licensed patents.

Employees & locations

• Employees (as of October 31, 2025): 82 employees total (81 full‑time); 51 primarily in research & development. Geographic split: 22 employees in Canada; 60 in the United States. None unionized.

Financials (reported)

• Revenue: Company has not generated any product revenue to date.
• Net loss (reported):
  • Fiscal year ended October 31, 2025: net loss of $117.3 million.
  • Fiscal year ended October 31, 2024: net loss of $55.1 million.
• Accumulated deficit: $372.0 million as of October 31, 2025.
• Liquidity (reported as of October 31, 2025): cash and cash equivalents $50.2 million; marketable securities $152.1 million.
• The Company has disclosed it will need additional financing to complete development and commercialization plans; it has an amended loan facility with Hercules Capital (terms and covenants referenced elsewhere in the filing).

Commercial strategy (stated plans)

• Primary plan: file a U.S. BLA for detalimogene in 2H 2026 for BCG‑unresponsive NMIBC with CIS (if clinical data support filing).
• Commercialization: intends to retain U.S. commercialization rights and build an internal U.S. commercial organization focused on community urology clinics; may selectively partner outside the United States.
• Pricing/market access: Company notes payor coverage and reimbursement issues will be important but has not reported finalized arrangements.

Competition (as stated)

• The filing lists multiple competitors and alternative therapies in the NMIBC space (examples): Ferring (Adstiladrin®), Merck (Keytruda®), ImmunityBio (Anktiva®), Johnson & Johnson (Inlexzo™), and other companies (e.g., Aura Biosciences, AstraZeneca, Bristol‑Myers Squibb, Roche, Gilead, CG Oncology, Protara, Pfizer, UroGen). Company states the field is competitive and that other approved or investigational products may compete for patients and market share.

Additional operational & program details

• Manufacturing/formulation specifics for detalimogene: plasmid DNA DS + DDX carrier + PEG‑b‑PLE excipient → sterile filtration → lyophilization → stable under standard refrigeration/freezer conditions (company claims).
• Preclinical data highlights: in an orthotopic murine bladder cancer model (MB49luc), a murine surrogate mEG‑70 showed dose‑dependent tumor reduction and >90% durable anti‑tumor responses in study animals; cured mice resisted local and distal tumor re‑challenge, consistent with antigen‑specific immune memory (preclinical claims).
• LEGEND trial endpoints: primary endpoint for pivotal Cohort 1 changed (company reports) to percentage of patients with complete response (CR) at any time (based on cystoscopy, urine cytology, and biopsy); secondary endpoints include duration of response, progression‑free survival, and cystectomy‑free survival.

Items not provided in the materials

• Number of customers: not stated.
• Product revenue by period or total revenue: no product revenue reported.
• Detailed balance sheet / P&L line items beyond the net loss figures and cash/marketable securities amounts above: not provided in the excerpt.

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