Humacyte, Inc. (NASDAQ: HUMA) Q2 2025 Earnings | 08/11/2025

10 days ago

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Inside Ticker

Earnings Calls

AI Summary

Humacyte Q2 2025 Earnings Call Summary

Key Highlights:

Commercial Launch of HAV (Human Acellular Vessel) – "HUMVEST":
- 82 civilian hospitals now approved to purchase (up from 5 in Q1) via Value Analysis Committees (VACs).
- First U.S. military sale after ECAT listing approval (access to ~35 military facilities + 160 VA hospitals).
- July sales: $0.3M (exceeding H1 2025 total).
- Pricing adjustment: Reduced from $29,500 to $24,250 to accelerate adoption.
Pipeline Progress:
- Dialysis Access (ATEV):
  - VO7 Phase 3 data (high-risk fistula patients) showed superior patency vs. fistulas (8 vs. 4.5 months usability; p=0.0002).
  - VO12 Phase 3 trial (women-only): 100/150 patients enrolled; interim analysis (80 patients) due April 2026.
  - Supplemental BLA submission planned for H2 2026.
- Coronary Artery Bypass Graft (CABG):
  - Primate data publication imminent; IND filing expected late 2025, trial start in 2026.
Regulatory/Reimbursement:
- CMS denied NTAP (New Technology Add-on Payment), citing lack of "unique mechanism" vs. existing grafts.
- Focus shifted to private payers (4.3% of trauma patients covered by Medicare).
Financials:
- Cash: $88.4M (post-$46.7M March 2025 offering).
- Cost reductions: $38M savings projected for 2026 (30 layoffs + deferred hires).
- Q2 revenue: $0.3M ($0.1M from HUMVEST sales, $0.2M from research collaboration).

Commercial & Operational Updates

HUMVEST Launch Dynamics

VAC Approvals: 13 multi-hospital systems (82 sites) approved; 40 additional VAC reviews underway.
Military/VA Opportunity: ECAT approval enables broader procurement; first reorder received from a major military base.
Headwinds: Delays due to detractor campaigns and economic pressures; momentum rebounding in June/July.

Dialysis Access Expansion

Target Population: High-risk patients (diabetes/obesity) with 50% fistula failure rates.
Regulatory Path: VO12 interim data (April 2026) could support early BLA filing; full data expected by H2 2026.

Financial & Strategic Priorities

Cash Runway: Extended through key milestones (dialysis BLA, CABG IND).
Focus Areas:
1. Drive HUMVEST adoption (civilian + military channels).
2. Complete VO12 enrollment (150 patients by YE 2025).
3. Advance CABG program (IND in late 2025).

Key Takeaways

Commercial Traction: Accelerating hospital approvals and military sales signal inflection point for HUMVEST.
Dialysis Potential: High-risk patient data positions ATEV as transformative alternative to fistulas.
Pipeline Catalysts: CABG IND (2025) and dialysis BLA (2026) next major milestones.

About this video

Humacyte, Inc. reported its second-quarter 2025 financial results, showing progress in commercial expansion but falling short of revenue expectations. GAAP revenue for Q2 was $0.3 million, significantly below the $1.0 million estimate. Of this, $0.1 million came from U.S. sales of Symvess, the company’s lead bioengineered vascular graft product, and $0.2 million from a research collaboration with a major medical technology partner. Despite slow commercial ramp-up, hospital access for Symvess expanded markedly, with 82 civilian hospitals approved to purchase the product by quarter-end—up from only 5 in May 2025. Early sales momentum was noted with 12 hospitals placing orders by quarter-end and several reordering in July. The company reported a GAAP net loss attributable to continuing operations of $37.7 million, an improvement from a $56.7 million loss in Q2 2024. Loss per share improved to $0.24 from $0.48 a year prior. Operating expenses were $30.0 million, slightly up 1.7% year-over-year, with cost controls implemented including a 30-person workforce reduction expected to yield significant savings in 2025 and 2026. Research and development expenses decreased year-over-year due to capitalization of commercial manufacturing overhead, while selling, general, and administrative expenses rose due to commercial launch activities and higher personnel costs. Operationally, the company continued clinical progress with an interim analysis planned for its pivotal V012 study, achieved enrollment for one-year follow-up of 80 patients, and plans to submit a supplemental Biologics License Application (BLA) in the second half of 2026 to expand Symvess indications to include arteriovenous access for hemodialysis. Additionally, Humacyte intends to file an Investigational New Drug (IND) application for a small diameter bioengineered blood vessel designed for coronary artery bypass grafting. As of June 30, 2025, cash, cash equivalents, and restricted cash totaled $88.4 million, supported by a capital raise earlier in the year, providing a solid financial runway for commercialization and ongoing development. Risks include continued slow commercialization typical for novel medical devices, the need for broader hospital adoption, reimbursement challenges, and clinical trial execution risks. About Inside Ticker: Inside Ticker delivers timely, in-depth financial news and earnings analysis to empower investors with actionable insights on global companies across sectors. For comprehensive video analysis and real-time updates, visit https://www.insideticker.com/. #Humacyte #HUMA #Q22025 #Earnings #FinancialResults #Revenue #NetLoss #EPS #Symvess #BioengineeredVessels #MedicalDevices #Commercialization #HospitalAccess #ClinicalTrials #BiologicsLicenseApplication #BLA #INDFiling #CostControls #WorkforceReduction #CashPosition #ResearchAndDevelopment #HealthcareInnovation #InvestorUpdates #NASDAQ #InsideTicker

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