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Humacyte (HUMA)

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Earnings summaries and quarterly performance for Humacyte.

Recent press releases and 8-K filings for HUMA.

Humacyte Announces Long-Term Safety and Efficacy Data for Symvess
HUMA
Product Launch
  • Humacyte announced the publication of long-term safety and efficacy data for Symvess in extremity arterial trauma repair, demonstrating high limb salvage and low infection rates for up to 36 months.
  • The study, which included 54 patients from the V005 Phase 2/3 study where autologous vein repair was not feasible, reported an infection-free rate of 92.9% from months 3–36 and limb salvage rates of 87.3% at 12 months and 82.5% at 24 months.
  • This data represents the first prospective long-term data in traumatic arterial repair using an off-the-shelf biologic conduit, highlighting Symvess as a reliable and innovative alternative.
  • Symvess (acellular tissue engineered vessel (ATEV)) received FDA approval for the vascular trauma indication in December 2024.
3 days ago
Humacyte, Inc. Secures $77.5 Million Senior Secured Term Loan Facility
HUMA
Debt Issuance
New Projects/Investments
  • Humacyte, Inc. and its wholly-owned subsidiary, Humacyte Global, Inc., entered into a senior secured term loan facility of up to $77,500,000 with Avenue Venture Opportunities Fund II, L.P. on December 15, 2025, which matures on December 1, 2029.
  • The facility includes an initial $40 million First Tranche Term Loan that was fully funded on the closing date, with two additional delayed draw tranches totaling $37.5 million available subject to specific revenue, regulatory approval, and liquidity conditions.
  • The Term Loans bear interest at the greater of 11.50% or the Wall Street Journal Prime Rate plus 4.50%.
  • In connection with the loan agreement, Humacyte issued a warrant to Avenue exercisable for shares of Common Stock based on a value of up to $5,037,500, with an exercise price of the lower of $1.28 or a specified equity sale price. Additionally, lenders may convert up to $2,500,000 of outstanding principal into Common Stock.
Dec 15, 2025, 9:52 PM
Humacyte Reports Q3 2025 Financial Results and Commercial Progress
HUMA
Earnings
Product Launch
Guidance Update
  • Humacyte reported Q3 2025 revenue of $0.8 million, including $0.7 million from U.S. Symvess sales, a substantial increase from $100,000 in the previous quarter.
  • Commercial traction for Symvess includes 25 Value Analysis Committee (VAC) approvals covering 92 civilian hospitals and the first commercial sale to U.S. military facilities after ECAT approval.
  • The company's net loss decreased to $17.5 million for Q3 2025, down from $39.2 million in the prior year, primarily due to a non-cash remeasurement of contingent earnout liability and reduced operating expenses.
  • Humacyte is on track for $50 million in cost savings for 2025-2026, with current cash expected to provide a runway beyond 12 months, covering key milestones such as the planned H2 2026 BLA filing for dialysis access.
  • The company has opted not to resubmit for NTAP in trauma, noting that price reductions have accelerated market activity and that only a small percentage of trauma patients are covered by Medicare.
Nov 12, 2025, 1:00 PM
Humacyte Reports Q3 2025 Financial Results and Commercial Progress
HUMA
Earnings
Product Launch
New Projects/Investments
  • Humacyte reported Q3 2025 revenue of $0.8 million, including $0.7 million from U.S. Symvess sales, a substantial increase from $100,000 in the prior quarter.
  • The company secured 25 Value Analysis Committee (VAC) approvals, making Symvess available to 92 civilian hospitals, with 45 additional VAC committees currently reviewing the product.
  • Net loss for Q3 2025 improved to $17.5 million, down from $39.2 million in the prior year, partially due to non-cash remeasurement and reduced operating expenses.
  • Humacyte is on track to achieve $50 million in cost savings for 2025-2026, with Q3 research and development expenses decreasing by $5 million quarter-over-quarter.
  • The company's $76 million cash balance is projected to fund operations beyond 12 months, supporting milestones such as the BLA filing for dialysis access in H2 2026 and first-in-human CABG studies in 2026.
Nov 12, 2025, 1:00 PM
Humacyte Reports Q3 2025 Financial Results and Symvess Commercial Progress
HUMA
Earnings
Product Launch
Guidance Update
  • Humacyte (HUMA) reported Q3 2025 revenue of $0.8 million, with $0.7 million attributed to U.S. sales of Symvess, a significant increase from $0.1 million in the previous quarter. For the nine months ended September 30, 2025, total revenue was $1.6 million.
  • The company's net loss for Q3 2025 was $17.5 million, a reduction from a net loss of $39.2 million in the prior year period, primarily due to a non-cash remeasurement of contingent earnout liability and decreased operating expenses.
  • The commercial launch of Symvess continues to advance, with 25 hospitals and/or healthcare systems having completed the Value Analysis Committee (VAC) process and approved its purchase, representing 92 civilian hospitals eligible to buy Symvess. An additional 45 VAC committees are currently reviewing Symvess. The majority of hospitals that have started ordering Symvess have also reordered.
  • As of September 30, 2025, Humacyte held $19.8 million in cash, cash equivalents, and restricted cash. Subsequent to this date, the company secured an additional $56.5 million in net proceeds from the sale of common stock and warrants, which is expected to provide a cash runway exceeding 12 months from November 12, 2025. The company is also on track to achieve $50 million in targeted cost savings for 2025 and 2026.
Nov 12, 2025, 1:00 PM
Humacyte Announces Third Quarter 2025 Financial Results and Business Update
HUMA
Earnings
Product Launch
New Projects/Investments
  • Humacyte reported total revenues of $753,000 for the third quarter of 2025, with Symvess sales reaching $703,000, a substantial increase from $100,000 in the second quarter.
  • The company's net loss for Q3 2025 was $17.5 million, a decrease from $39.2 million in the prior year period.
  • As of September 30, 2025, cash, cash equivalents, and restricted cash totaled $19.8 million.
  • Symvess market access expanded to 92 civilian hospitals through 25 Value Analysis Committee (VAC) approvals.
  • Humacyte advanced its pipeline with positive two-year results for the ATEV in dialysis from the V007 Phase 3 trial and submitted an Investigational New Drug (IND) application for the Coronary Tissue Engineered Vessel (CTEV) in the CABG indication, with plans for a first-in-human study in 2026.
Nov 12, 2025, 12:06 PM
Humata Health Partners with CMS for WISeR Model
HUMA
New Projects/Investments
Product Launch
  • Humata Health has been selected by the Centers for Medicare & Medicaid (CMS) as a key partner for its WISeR model, an initiative to make clinical approvals faster, fairer, and more efficient using AI-powered prior authorization technology.
  • The WISeR model will launch in January 2026 in six states, with Humata Health serving as the primary technology partner for Oklahoma to process prior authorization requests for a specific list of 17 items and services.
  • Humata's AI technology is designed to accelerate approvals by matching clinical documentation to Medicare policy criteria, delivering rapid automated "yes" decisions, and has previously demonstrated improvements in authorization cycle times by over 50% and reductions in preventable denials by up to 40%.
Nov 7, 2025, 3:00 PM
Humacyte to Release Third Quarter 2025 Financial Results and Provide Business Update
HUMA
Earnings
Product Launch
  • Humacyte, Inc. (Nasdaq: HUMA) is scheduled to release its third quarter 2025 financial results for the period ended September 30, 2025, on November 12, 2025.
  • Management will host a webcast and conference call at 8:00 a.m. ET on November 12, 2025, to provide a corporate and financial update.
  • The company's Biologics License Application for its acellular tissue engineered vessel (ATEV) in the vascular trauma indication received FDA approval in December 2024.
Nov 6, 2025, 1:00 PM
Humacyte announces pricing of $60.0 million registered direct offering
HUMA
  • Humacyte, Inc. announced the pricing of an oversubscribed registered direct offering, expecting to generate approximately $60.0 million in gross proceeds before fees and expenses.
  • The offering involves the sale of 28,436,018 shares of common stock and warrants to purchase an equal number of shares.
  • The purchase price for one share of common stock and one warrant is $2.11.
  • The warrants will become exercisable 180 days following issuance, have an exercise price of $2.11 per share, and will expire on April 7, 2031.
  • The offering is expected to close on or about October 8, 2025.
Oct 7, 2025, 9:31 PM
Humacyte Announces Positive Long-Term Results for Symvess in Wartime Trauma
HUMA
Product Launch
New Projects/Investments
  • Humacyte announced the publication of positive long-term results for its Symvess product, used to treat wartime vascular trauma injuries in Ukraine.
  • The study, published in Military Medicine, reported a continued high rate of patency (87.1%), 100% limb salvage, and zero cases of conduit infection in 17 patients followed for up to 18 months.
  • Patients treated with Symvess experienced zero deaths, zero amputations, and zero infections at both 30 days and up to 18 months of follow-up.
  • Symvess, an acellular tissue engineered vessel, is designed for immediate off-the-shelf availability, which is critical for wartime situations.
  • The FDA approved Humacyte's Biologics License Application for ATEV in the vascular trauma indication in December 2024.
Oct 6, 2025, 12:00 PM