Recent 8-K filings for HUMA
Highest-materiality recent filing
Humacyte receives FDA full approval for SYMVESS in extremity arterial injury
- FDA grants full approval for SYMVESS as a vascular conduit for extremity arterial injury when autologous vein graft is not feasible.
- In clinical trials, SYMVESS showed high patency rates and low rates of amputation and infection; results published in JAMA Surgery.
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Humacyte receives Nasdaq deficiency notice for bid price below $1.00; 180 days to comply
Received Nasdaq letter on May 4, 2026, for bid price below $1.00 for 30 consecutive business days through May 1, 2026.
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Humacyte regains ex-U.S. rights to Symvess from Fresenius, pays low-single-digit royalties
Humacyte obtains sole worldwide rights to develop and commercialize Symvess; Fresenius retains U.S. distribution terms unchanged.
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Humacyte reports preliminary FY2025 revenue $2M, 61 Symvess units; suspends ATM
Preliminary FY2025: cash $50.9M, total revenue $2.0M (product $1.4M), 61 Symvess unit sales.
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Humacyte announces $20M registered direct offering of 25M shares at $0.80/share
Gross proceeds of $20M from 25M shares at $0.80; net proceeds ~$18.4M after fees.
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Humacyte terminates Revenue Interest Purchase Agreement; pays $38M cash + 5.7M shares to purchasers
Terminated Revenue Interest Purchase Agreement and Option Agreement with TPC Investments LP and Hook SA LLC as of Dec 15, 2025.
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Humacyte secures up to $77.5M senior secured loan facility from Avenue; draws $40M initial tranche
Loan agreement provides $40M upfront, plus $12.5M delayed draw (Oct 2026-Mar 2027) and $25M discretionary tranche (Jul 2027-Jun 2028).
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Total revenue $753K in Q3, all from Symvess sales; no revenue in Q3 2024.
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Humacyte prices $60M registered direct offering of common stock and warrants
Raised $60.0M via sale of 28.4M shares and warrants to purchase 28.4M shares at $2.11 per unit.
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Humacyte (HUMA) amends revenue interest purchase agreement; $50M repayment, discounted call option
Company to make $50.0M repayment under Purchase Agreement from restricted cash.
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Revenue $0.3M in Q2 (incl $0.1M Symvess sales); $0.8M in H1 2025 vs zero prior year.
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Humacyte posts Q1 net income $39.1M; Symvess launch generates $147K revenue
Q1 2025 revenue $517K ($147K from first Symvess commercial sales); no revenue in Q1 2024.
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Humacyte posts Q4 net loss of $20.9M; Symvess commercial launch underway after FDA approval
Net loss Q4 2024 $20.9M vs $25.1M Q4 2023; full year net loss $148.7M vs $110.8M.
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Humacyte CEO rebuts NYT article questioning FDA approval of Symvess
FDA took 19 extra weeks after PDUFA date, consulted three outside surgeons before approving Symvess on Dec 19, 2024.
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Humacyte prices 25M-share public offering at $2.00/share, expects $50M gross proceeds
Offering of 25,000,000 shares at $2.00/share; gross proceeds ~$50M, net ~$46.6M after discounts and expenses.
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Humacyte receives FDA full approval for SYMVESS in extremity arterial injury
FDA grants full approval for SYMVESS as a vascular conduit for extremity arterial injury when autologous vein graft is not feasible.
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Humacyte Q3 net loss $39.2M; ATEV BLA review ongoing with no new timeline
Net loss $39.2M (Q3 2024) vs $26.0M (Q3 2023) driven by non-cash contingent earnout remeasurement.
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Humacyte ATEV meets Phase 3 co-primary endpoints; superior to AV fistula in hemodialysis
ATEV showed functional patency 81.3% at 6 months vs 66.4% for AV fistula; secondary patency 68.3% vs 62.2% at 12 months (joint p=0.0071).
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Humacyte prices $30M registered direct offering of common stock and warrants at $5.28/unit
Offering of 5,681,820 common shares and 5,681,820 warrants at $5.28 per unit.
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Humacyte enters $50M equity purchase agreement with Lincoln Park Capital
Company can sell up to $50M of common stock to Lincoln Park over 24 months at its discretion.
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FDA delays ATEV trauma BLA review beyond PDUFA date; Q2 net loss $56.7M
FDA notified Humacyte on Aug 9 that additional time needed to complete ATEV BLA review; PDUFA date was Aug 10; no revised action date yet.
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Humacyte ATEV meets Phase 3 endpoints in hemodialysis access; superiority over standard of care
ATEV showed superior functional patency at 6 months (81.3% vs 66.4%) and secondary patency at 12 months (68.3% vs 62.2%); p=0.0071.
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Humacyte Q1 net loss $31.9M; FDA grants Priority Review for HAV, PDUFA Aug 10, 2024
Net loss $31.9M vs $37.0M YoY; no revenue; cash $115.5M, up from $35.1M net provided.
Earnings & guidance
Materiality & sentiment trend
Max materiality 0.85 · Median 0.65 · Most common event other_material