Humacyte Announces Fourth Quarter and Year End 2024 Financial Results and Provides Business Update
Humacyte (NASDAQ: HUMA) announced its Q4 and full-year 2024 financial results, highlighting the FDA approval of Symvess™ for extremity vascular trauma treatment in December 2024. The company has initiated commercial launch with first sales in February 2025, with 34 hospitals starting the Value Analysis Committee approval process and three hospitals already approving purchases.
Financial highlights show no revenue for Q4 and full-year 2024. R&D expenses were $20.7M in Q4 2024 and $88.6M for the full year. Net loss increased to $148.7M for 2024, compared to $110.8M in 2023. The company reported $95.3M in cash and equivalents as of December 31, 2024, with an additional $46.6M raised through a public offering in March 2025.
Key developments include positive Phase 3 trial results for arteriovenous access in dialysis patients, plans for a supplemental BLA submission in H2 2026, and an upcoming IND filing in 2025 for coronary artery bypass grafting studies.
Humacyte (NASDAQ: HUMA) ha annunciato i risultati finanziari del quarto trimestre e dell'intero anno 2024, evidenziando l'approvazione da parte della FDA di Symvess™ per il trattamento del trauma vascolare degli arti, avvenuta a dicembre 2024. L'azienda ha avviato il lancio commerciale con le prime vendite a febbraio 2025, con 34 ospedali che hanno iniziato il processo di approvazione del Value Analysis Committee e tre ospedali che hanno già approvato gli acquisti.
I risultati finanziari mostrano nessun ricavo per il quarto trimestre e l'intero anno 2024. Le spese per R&S sono state di 20,7 milioni di dollari nel quarto trimestre 2024 e di 88,6 milioni per l'intero anno. La perdita netta è aumentata a 148,7 milioni di dollari per il 2024, rispetto ai 110,8 milioni del 2023. L'azienda ha riportato 95,3 milioni di dollari in contante e equivalenti al 31 dicembre 2024, con ulteriori 46,6 milioni raccolti tramite un'offerta pubblica a marzo 2025.
Sviluppi chiave includono risultati positivi della fase 3 per l'accesso arteriovenoso nei pazienti in dialisi, piani per una sottomissione supplementare della BLA nel secondo semestre del 2026, e un imminente deposito IND nel 2025 per studi sul bypass coronarico.
Humacyte (NASDAQ: HUMA) anunció sus resultados financieros del cuarto trimestre y del año completo 2024, destacando la aprobación de la FDA de Symvess™ para el tratamiento del trauma vascular de extremidades en diciembre de 2024. La compañía ha iniciado el lanzamiento comercial con las primeras ventas en febrero de 2025, con 34 hospitales comenzando el proceso de aprobación del Comité de Análisis de Valor y tres hospitales ya aprobando compras.
Los aspectos financieros muestran que no hubo ingresos para el cuarto trimestre ni para el año completo 2024. Los gastos en I+D fueron de 20,7 millones de dólares en el cuarto trimestre de 2024 y de 88,6 millones para el año completo. La pérdida neta aumentó a 148,7 millones de dólares para 2024, en comparación con 110,8 millones en 2023. La compañía reportó 95,3 millones de dólares en efectivo y equivalentes al 31 de diciembre de 2024, con 46,6 millones adicionales recaudados a través de una oferta pública en marzo de 2025.
Los desarrollos clave incluyen resultados positivos de ensayos de fase 3 para el acceso arteriovenoso en pacientes en diálisis, planes para una presentación suplementaria de BLA en la segunda mitad de 2026, y un próximo depósito de IND en 2025 para estudios de injertos de bypass de arteria coronaria.
Humacyte (NASDAQ: HUMA)는 2024년 4분기 및 연간 재무 결과를 발표하며, 2024년 12월에 Symvess™가 사지 혈관 외상 치료를 위한 FDA 승인을 받았음을 강조했습니다. 이 회사는 2025년 2월 첫 판매를 시작으로 상업적 출시를 시작했으며, 34개 병원이 가치 분석 위원회 승인 프로세스를 시작하고 3개 병원이 이미 구매를 승인했습니다.
재무 하이라이트에 따르면 2024년 4분기 및 연간 수익은 없었습니다. R&D 비용은 2024년 4분기에 2,070만 달러, 연간 8,860만 달러였습니다. 2024년 순손실은 1억 4,870만 달러로 증가했으며, 이는 2023년의 1억 1,080만 달러와 비교됩니다. 이 회사는 2024년 12월 31일 기준으로 9,530만 달러의 현금 및 현금성 자산을 보고했으며, 2025년 3월에 공모를 통해 추가로 4,660만 달러를 조달했습니다.
주요 개발 사항으로는 투석 환자에 대한 동정맥 접근에 대한 3상 시험 결과가 긍정적이었고, 2026년 하반기에 보충 BLA 제출 계획이 있으며, 2025년에는 관상동맥 우회 수술 연구를 위한 IND 제출이 예정되어 있습니다.
Humacyte (NASDAQ: HUMA) a annoncé ses résultats financiers pour le quatrième trimestre et l'année complète 2024, mettant en avant l'approbation par la FDA de Symvess™ pour le traitement des traumatismes vasculaires des membres en décembre 2024. L'entreprise a lancé son lancement commercial avec les premières ventes en février 2025, avec 34 hôpitaux ayant commencé le processus d'approbation du Comité d'Analyse de Valeur et trois hôpitaux ayant déjà approuvé des achats.
Les points saillants financiers montrent qu'il n'y a eu aucun revenu pour le quatrième trimestre et l'année complète 2024. Les dépenses de R&D étaient de 20,7 millions de dollars au quatrième trimestre 2024 et de 88,6 millions pour l'année complète. La perte nette a augmenté à 148,7 millions de dollars pour 2024, contre 110,8 millions en 2023. L'entreprise a déclaré avoir 95,3 millions de dollars en liquidités et équivalents au 31 décembre 2024, avec 46,6 millions de dollars supplémentaires levés par le biais d'une offre publique en mars 2025.
Les développements clés incluent des résultats positifs des essais de phase 3 pour l'accès artérioveineux chez les patients sous dialyse, des plans pour une soumission BLA complémentaire au second semestre 2026, et un prochain dépôt IND en 2025 pour des études de pontage coronarien.
Humacyte (NASDAQ: HUMA) gab die finanziellen Ergebnisse für das vierte Quartal und das Gesamtjahr 2024 bekannt und hob die FDA-Zulassung von Symvess™ zur Behandlung von Gefäßtrauma an Extremitäten im Dezember 2024 hervor. Das Unternehmen hat den kommerziellen Launch mit den ersten Verkäufen im Februar 2025 eingeleitet, wobei 34 Krankenhäuser den Genehmigungsprozess des Value Analysis Committee begonnen haben und drei Krankenhäuser bereits Käufe genehmigt haben.
Die finanziellen Höhepunkte zeigen keine Einnahmen für das vierte Quartal und das Gesamtjahr 2024. Die F&E-Ausgaben betrugen im vierten Quartal 2024 20,7 Millionen US-Dollar und für das gesamte Jahr 88,6 Millionen US-Dollar. Der Nettoverlust stieg auf 148,7 Millionen US-Dollar für 2024, verglichen mit 110,8 Millionen US-Dollar im Jahr 2023. Das Unternehmen berichtete zum 31. Dezember 2024 über 95,3 Millionen US-Dollar an Bargeld und Äquivalenten, mit weiteren 46,6 Millionen US-Dollar, die im März 2025 über ein öffentliches Angebot eingeworben wurden.
Wichtige Entwicklungen umfassen positive Ergebnisse der Phase-3-Studien für arteriovenösen Zugang bei Dialysepatienten, Pläne für eine ergänzende BLA-Einreichung im zweiten Halbjahr 2026 und eine bevorstehende IND-Einreichung im Jahr 2025 für Studien zur koronaren Bypass-Transplantation.
- FDA approval of Symvess for vascular trauma treatment received in December 2024
- 34 hospitals initiated VAC approval process with 3 already approved
- First commercial sales of Symvess achieved in February 2025
- Positive Phase 3 trial results for dialysis application
- Additional $46.6M capital raised in March 2025
- No revenue generated in Q4 and full-year 2024
- Net loss increased to $148.7M in 2024 from $110.8M in 2023
- R&D expenses increased to $88.6M in 2024 from $76.6M in 2023
- Ongoing cash burn requiring additional fundraising
Insights
Humacyte's Q4 and full-year 2024 results mark a pivotal transition from development to commercialization following FDA approval of Symvess in December 2024. While financial metrics show increased losses -
The early commercial traction is encouraging with 34 hospitals already initiating the Value Analysis Committee approval process and the first commercial shipments completed in February 2025. This pace of institutional engagement exceeds typical adoption curves for novel medical devices, suggesting strong market interest. The recently published Budget Impact Model demonstrating cost-effectiveness through reduced amputations and infections provides critical economic validation to support reimbursement decisions.
Cash position remains adequate at
The broader pipeline demonstrates impressive momentum, particularly the positive Phase 3 results in dialysis access showing superior outcomes to the current standard of care. The planned 2025 IND filing for coronary applications represents a substantial market expansion opportunity beyond vascular trauma.
The FDA approval of Symvess represents a genuine paradigm shift in vascular trauma management. The clinical significance cannot be overstated - this is the first acellular bioengineered vessel approved for extremity vascular trauma where traditional autologous vein grafts aren't feasible.
From a surgical perspective, the value proposition is compelling: Symvess addresses a critical unmet need for off-the-shelf vascular conduits that perform better than synthetic alternatives. The published clinical data shows reduced infection rates and limb salvage benefits that align with what many of us observed in the clinical trials.
The rapid initiation of 34 hospital VAC processes demonstrates unusual enthusiasm within the vascular surgery community. Three hospitals completing this typically lengthy process already signals exceptional demand. The therapeutic advantages - particularly for complex trauma patients with autologous vessel options - justifies the premium positioning.
Beyond trauma applications, the dialysis access data presented at ASN Kidney Week is particularly noteworthy. The superior patency rates compared to arteriovenous fistulas, especially in traditionally challenging populations (female, diabetic, and obese patients), addresses a major frustration point in vascular access. The planned supplemental BLA in 2026 could establish Humacyte's technology as the new standard for multiple vascular applications.
The small-diameter vessel development for coronary bypass further demonstrates the platform's versatility and potential to transform multiple areas of vascular surgery where current options remain suboptimal.
- Received U.S. Food and Drug Administration (FDA) approval of Symvess™ (acellular tissue engineered vessel-tyod) for the treatment of extremity vascular trauma -
- Commenced market launch and first commercial sales of Symvess -
- Budget Impact Model for Symvess published in Journal of Medical Economics -
- IND filing planned in 2025 to support first-in-human clinical study of small-diameter ATEV™ for coronary artery bypass grafting -
- Conference call today at 8:30am ET -
DURHAM, N.C., March 28, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced financial results for the fourth quarter and year ended December 31, 2024, and provided a business update.
“The past year has been a landmark time for Humacyte, highlighted by the FDA’s approval of Symvess for the treatment of extremity vascular trauma,” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “Symvess is a biologic product that went through more than 20 years of research and development, and we believe that this first-in-class approval marks an important new era in vascular surgery. We are thrilled to deliver this transformative innovation to surgeons and patients in need of a new option to save limbs and lives. Results from our clinical studies suggest that there are patients walking on their own legs today who would not be doing so if Symvess were not available.”
“Our commercial launch of Symvess is proceeding at full speed and we are excited by the response to date from hospitals and healthcare providers,” continued Dr. Niklason. “So far the market has responded well, and 34 hospitals have already initiated the Value Analysis Committee (VAC) approval process. We are also excited that just 16 days after having the commercial inventory availability, we made our first shipments of Symvess. The potential health economic benefits of Symvess are supported by our Budget Impact Model that was just published in the Journal of Medical Economics, which concludes that the avoidance of vascular infections and amputations drive cost reduction with the use of Symvess in traumatic injury. Our commercial team will continue to work closely with health care providers to make Symvess available to patients in need nationwide.”
Fourth Quarter, Year End 2024 and Recent Corporate Highlights
Symvess FDA Approval and Market Launch
- FDA Approval: The FDA granted full approval for Symvess on December 19, 2024 for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.
- VAC Approval Process: Commencement of sales to hospitals for new products typically requires review and approval by a VAC, which is a centralized decision-making body within the institution. Thirty-four hospitals have already initiated the VAC approval process, with additional hospitals expected to commence the process in the near term. These hospitals are a mix of leading trauma centers that were participants in Humacyte clinical studies, combined with institutions that have been newly introduced to Symvess. VACs have been engaged from individual institutions, and from larger hospital networks, meaning that individual VAC approvals could apply to multiple hospitals. Although the VAC process often takes three to six months to complete, three hospitals have already approved the purchase of Symvess.
- First Commercial Sales: Humacyte commenced its commercial launch of Symvess in late February 2025 after the first commercial batch was released by the FDA. The first commercial shipments containing multiple units of Symvess were made last week to two Level 1 trauma centers.
- Economic Value of Symvess: The Company’s Budget Impact Model was published several weeks ago in the Journal of Medical Economics. Based on the model, the per-patient cost of treating patients with Symvess is estimated to be less than the cost of treating trauma patients with synthetic grafts, cryopreserved allografts, or xenografts. Major drivers of cost savings were attributed to reductions in the rate of amputation and vascular conduit infection.
- NTAP Reimbursement: In October 2024, Humacyte submitted a New Technology Add-On Payment (NTAP) application for Symvess to the Centers for Medicare and Medicaid Services (CMS). Humacyte presented the Symvess data at a public town hall with CMS in December 2024. If successful, NTAP reimbursement will begin on October 1, 2025, offering hospitals additional payment to cover a portion of the costs associated with purchasing Symvess.
- Manufacturing Patent: In January 2025, Humacyte was issued a new U.S. Patent covering key aspects of our biomanufacturing platform. The newly issued patent provides protection into 2040, and complements a family of existing patents and patent applications encompassing the design and composition of Symvess and Humacyte’s product candidates, and their methods of manufacture.
ATEV Earlier Stage Pipeline and Corporate Updates
- V007 Results in Dialysis: Positive results from the V007 Phase 3 clinical trial of the ATEV in arteriovenous (AV) access for patients with end-stage renal disease were presented in October 2024 at the American Society of Nephrology’s (ASN) Kidney Week 2024. The Phase 3 study met the co-primary endpoints, and the ATEV was observed to have superior function and patency (blood flow) at 6 and 12 months compared to AV fistula, which is the current standard of care for hemodialysis patients. The ATEV was also observed to have superior function in female, obese, and diabetic patients, each of which is a high-need subgroup having historically poor outcomes with AV fistula.
- Planned Supplemental BLA in Dialysis: A total of 76 patients have been enrolled to date in the V012 Phase 3 trial, which is designed to assess the usability of the ATEV for dialysis in comparison to AV fistulas in female patients. An interim analysis is planned when the first 80 patients reach one-year of follow up. Subject to these interim results, Humacyte’s plan is to submit a supplemental BLA in the second half of 2026, that includes data from V012 and V007, to add AV access for hemodialysis as an indication for the ATEV.
- Planned IND Filing in CABG: Humacyte plans to file an Investigational New Drug (IND) application with the FDA to enable first-in-human clinical testing of the small-diameter (3.5mm) acellular tissue engineered vessel (sdATEV) in coronary artery bypass grafting (CABG). Results of a six-month preclinical study of the sdATEV in primates were presented in November 2024 at The American Heart Association’s Scientific Sessions 2024 meeting. In the preclinical CABG model, the sdATEV was observed to sustain patency, recellularized with the animals’ host cells, and remodel so as to match the size of the animals’ native coronary arteries.
Fourth Quarter and Full Year 2024 Financial Highlights
- There was no revenue for the fourth quarter of 2024 and 2023, and there was no revenue for the years ended December 31, 2024 and 2023.
- Research and development expenses were
$20.7 million for the fourth quarter of 2024, less than the$22.9 million incurred for the third quarter of 2024. The decrease in expenses compared to the prior quarter was primarily attributed to a reduction in materials expenses due to the timing of manufacturing runs. Research and development expenses for the fourth quarter of 2024 were$20.7 million , a slight increase compared to the$20.2 million incurred in the fourth quarter of 2023. Research and development expenses were$88.6 million for the year ended December 31, 2024, compared to$76.6 million for the year ended December 31, 2023. The increase in expenses during the year ended December 31, 2024 resulted primarily from increased materials expense associated with manufacturing runs and personnel expenses. These increases supported expanded research and development initiatives and clinical trials, including the expansion of manufacturing activities and support of the FDA review of the BLA in extremity vascular trauma. - General and administrative expenses were
$7.4 million for the fourth quarter of 2024, consistent with the$7.3 million incurred for the third quarter of 2024. General and administrative expenses were$7.4 million for the fourth quarter of 2024 compared to$6.0 million for the fourth quarter of 2023, and were$25.8 million for the year ended December 31, 2024 compared to$23.5 million for the year ended December 31, 2023. The increases during 2024 resulted primarily from preparation for the planned commercial launch of Symvess, including increases in personnel expenses and professional fees. These increases were partially offset by a decrease in non-cash stock compensation expense during 2024. - Other net income (expense) was net income of
$7.1 million for the fourth quarter of 2024, compared to net expense of$9.0 million for the third quarter of 2024. The increase in other net income compared to the prior quarter was due to the non-cash remeasurement of the contingent earnout liability associated with the Company’s 2021 merger with Alpha Healthcare Acquisition Corp. Other net income for the fourth quarter of 2024 was$7.1 million compared to other net income of$1.1 million for the fourth quarter of 2023, and other net expense of$34.3 million for the year ended December 31, 2024 compared to net expense of$10.7 million for the year ended December 31, 2023. The increase in other net income during the fourth quarter of 2024 compared to 2023, and the increase in other net expense during the year ended December 31, 2024 compared to 2023, resulted primarily from non-cash remeasurements of the contingent earnout liability. - Net loss was
$20.9 million for the fourth quarter of 2024, compared to$39.2 million for the third quarter of 2024 and to$25.1 million for the fourth quarter of 2023. The decreases in net loss for the fourth quarter of 2024 compared to the prior quarter and to the fourth quarter of 2023 resulted from the non-cash remeasurement of the contingent earnout liability described above. Net loss was$148.7 million for the year ended December 31, 2024 compared to$110.8 million for the year ended December 31, 2023. The year-over-year increase in net loss in 2024 compared to 2023 resulted from the non-cash remeasurement of the contingent earnout liability and operating expense increases, both described above. - The Company reported cash, cash equivalents and restricted cash of
$95.3 million as of December 31, 2024. Subsequent to December 31, 2024, in March 2025 the Company completed an underwritten public offering of common stock which provided approximately$46.6 million in net proceeds, with the potential for another$7.1 million in net proceeds subject to an underwriter option that is exercisable before April 26, 2025. Total net cash provided was$14.5 million for the year ended December 31, 2024, compared to total net cash used of$69.0 million for the year ended December 31, 2023. The increase in net cash provided resulted primarily from the receipt of approximately$43.0 million in net proceeds from an underwritten public offering of common stock in March 2024,$43.1 million in net proceeds from two registered direct offerings of common stock and warrants completed in October and November 2024, and$20 million in proceeds from an additional draw under Humacyte’s funding arrangement with Oberland Capital Management.
Conference Call and Webcast Details
| Title: | Humacyte Fourth Quarter and Full Year 2024 Financial Results and Corporate Update |
| Date: | March 28, 2025 |
| Time: | 8:30 AM Eastern Time |
| Conference Call Details: | 1-877-704-4453 (U.S. Investors Dial) 1-201-389-0920 (International Investors Dial) 13751524 (Conference ID) |
| Call meTM Feature: | Click Here |
| Webcast: | Click Here |
A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the investors section of the Company’s website for at least 30 days.
INDICATION
Symvess is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: GRAFT FAILURE
Loss of Symvess integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage.
CONTRAINDICATIONS
DO NOT use Symvess in patients who have a medical condition that would preclude long-term antiplatelet therapy (such as aspirin or clopidogrel) after resolution of acute injuries.
WARNINGS AND PRECAUTIONS
- Graft Rupture
Vascular graft rupture has occurred in patients treated with Symvess. Advise patients that arterial bleeding can be life-threatening and to seek emergent medical evaluation for any signs or symptoms of graft rupture such as bleeding, pain and swelling in the extremity, or signs of extremity ischemia.
- Anastomotic Failure
Anastomotic failure has occurred in patients treated with Symvess. In clinical studies of Symvess, anastomotic failure occurred within the first 36 days post-implantation. Monitor patients for signs of anastomotic failure such as pain and swelling at the surgical site, decreasing hemoglobin or other signs and symptoms of bleeding. Advise patients to seek urgent medical evaluation if they have any signs or symptoms that may be indicative of anastomotic failure such as bleeding, swelling or worsening pain at the surgical site or changes in color of overlying skin.
- Thrombosis
Thrombosis has occurred in patients treated with Symvess. In clinical trials of Symvess, patients received antiplatelet therapy following implantation of Symvess to reduce the risk of thrombosis. The risk of thrombosis may increase in patients who discontinue antiplatelet therapy. Anti-platelet therapy is recommended following treatment with Symvess.
- Transmission of Infectious Diseases
Symvess is manufactured using cells and reagents that may transmit infectious diseases or infectious agents. The cells used in the manufacture of Symvess are derived from a donor who met the donor eligibility requirements for transmissible infectious diseases which includes screening and testing of risks associated with human immunodeficiency virus 1 (HIV-1), human immunodeficiency virus 2 (HIV-2), hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis (Treponema pallidum). The cell banks are tested negative for human and animal viruses, retroviruses, bacteria, fungi, yeast, and mycoplasma. While all animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use, these measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Fetal bovine serum is sourced to minimize the risk of transmitting a prion protein that causes bovine spongiform encephalopathy and the cause of a rare fatal condition in humans called variant Creutzfeldt-Jakob disease. No transmissible agent infections have been reported during clinical testing.
ADVERSE REACTIONS
The most common adverse reactions (occurring at ≥
Please see full Prescribing Information at www.symvess.com, including Boxed Warning, for Symvess.
About Humacyte
Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.
For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
Forward-Looking Statements
This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, our plans and ability to commercialize our ATEV in the United States under the brand name Symvess in vascular trauma repair; the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our ATEVs; our ability to successfully complete preclinical and clinical trials for our ATEVs; the anticipated benefits of the ATEV relative to existing alternatives; the anticipated commercialization of our ATEVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, each filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
Humacyte Investor Contact:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com
investors@humacyte.com
Humacyte Media Contact:
Rich Luchette
Precision Strategies
+1-202-845-3924
rich@precisionstrategies.com
media@humacyte.com
| Humacyte, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) (in thousands except for share and per share amounts) | |||||||||||||||
| Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Revenue | $ | — | $ | — | $ | — | $ | — | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 20,656 | 20,180 | 88,599 | 76,550 | |||||||||||
| General and administrative | 7,432 | 6,002 | 25,799 | 23,497 | |||||||||||
| Total operating expenses | 28,088 | 26,182 | 114,398 | 100,047 | |||||||||||
| Loss from operations | (28,088 | ) | (26,182 | ) | (114,398 | ) | (100,047 | ) | |||||||
| Other income (expense), net | |||||||||||||||
| Change in fair value of contingent earnout liability | 5,608 | 1,685 | (33,045 | ) | (10,023 | ) | |||||||||
| Other income (expense) (net) | 1,540 | (609 | ) | (1,258 | ) | (706 | ) | ||||||||
| Total other income (expense), net | 7,148 | 1,076 | (34,303 | ) | (10,729 | ) | |||||||||
| Net loss and comprehensive loss | $ | (20,940 | ) | $ | (25,106 | ) | $ | (148,701 | ) | $ | (110,776 | ) | |||
| Net loss per share, basic and diluted | $ | (0.16 | ) | $ | (0.24 | ) | $ | (1.26 | ) | $ | (1.07 | ) | |||
| Weighted-average shares outstanding, basic and diluted | 126,983,464 | 103,607,631 | 118,479,097 | 103,420,238 | |||||||||||
| Humacyte, Inc. Condensed Consolidated Balance Sheets (unaudited) (in thousands) | |||||||
| As of December 31, | |||||||
| 2024 | 2023 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 44,937 | $ | 80,448 | |||
| Prepaid expenses and other current assets | 2,922 | 2,830 | |||||
| Total current assets | 47,859 | 83,278 | |||||
| Restricted cash | 50,209 | 209 | |||||
| Property, plant and equipment, net | 23,063 | 26,791 | |||||
| Finance lease right-of-use assets, net | 15,490 | 17,313 | |||||
| Other long-term assets | 1,251 | 632 | |||||
| Total assets | $ | 137,872 | $ | 128,223 | |||
| Liabilities and Stockholders’ Equity (Deficit) | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 4,490 | $ | 6,490 | |||
| Accrued expenses | 11,424 | 9,340 | |||||
| Other current liabilities | 4,040 | 2,613 | |||||
| Total current liabilities | 19,954 | 18,443 | |||||
| Contingent earnout liability | 70,961 | 37,916 | |||||
| Revenue interest liability | 63,354 | 38,600 | |||||
| Common stock warrant liabilities | 19,254 | 78 | |||||
| Finance lease obligation, net of current portion | 13,620 | 16,293 | |||||
| Other long-term liabilities | 3,398 | 3,347 | |||||
| Total liabilities | 190,541 | 114,677 | |||||
| Stockholders’ equity (deficit) | |||||||
| Common stock and additional paid-in capital | 633,346 | 550,860 | |||||
| Accumulated deficit | (686,015 | ) | (537,314 | ) | |||
| Total stockholders’ equity (deficit) | (52,669 | ) | 13,546 | ||||
| Total liabilities and stockholders’ equity (deficit) | $ | 137,872 | $ | 128,223 | |||
FAQ
What are the key financial results for Humacyte (HUMA) in Q4 2024?
When did Humacyte receive FDA approval for Symvess and what is its use?
How many hospitals have initiated the VAC approval process for Symvess as of March 2025?
What are Humacyte's plans for its dialysis treatment program?
How much additional funding did Humacyte secure in March 2025?
