Humacyte, Inc. engages in the development and manufacture of off-the-shelf, implantable, and bioengineered human tissues for the treatment of diseases and conditions across a range of anatomic locations in multiple therapeutic areas. The company using its proprietary and scientific technology platform to engineer and manufacture human acellular vessels (HAVs). Its investigational HAVs are designed to be easily implanted into any patient without inducing a foreign body response or leading to immune rejection. The company is developing a portfolio of HAVs, which would target the vascular repair, reconstruction, and replacement market, including vascular trauma; arteriovenous access for hemodialysis; peripheral arterial disease; and coronary artery bypass grafting, as well as developing its HAVs for pediatric heart surgery and cellular therapy delivery, including pancreatic islet cell transplantation to treat Type 1 diabetes. The company was founded in 2004 and is headquartered in Durham, North Carolina.

Humacyte, Inc.

Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues and organs 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 initial opportunity, a portfolio of human acellular vessels (HAVs), is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral arterial disease. 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 HAVs for AV access for performing hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) expedited review designation, and the HAV technology received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.

Fresenius Medical Care

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Humacyte

Today, we submitted our first Biologics License Application (BLA) to the FDA for the use of our investigational Human Acellular Vessel™ (HAV™) to help treat patients with vascular trauma. Our application cites outstanding data from multiple trials showing the HAV's safety and efficacy.

This is a huge milestone in our work and an exciting step for the future of regenerative medicine. The BLA submission is supported by positive results from the V005 Phase 2/3 clinical trial as well as from the treatment of wartime trauma injuries in Ukraine where our HAV demonstrated higher patency (blood flow) rates, lower infection rates, and lower amputation rates when compared to historical synthetic graft benchmarks. We’ve taken great care to show the safety and efficacy of our HAV, because we know what’s on the line when a surgeon reaches for an HAV: people’s life, limbs, and livelihoods.

In addition to this BLA, our company is currently in late-stage clinical trials targeting multiple vascular applications, including AV access for hemodialysis, and peripheral arterial disease. Make sure to follow us to see how our work progresses. https://lnkd.in/e9XEcGzB

This #DiabetesAwarenessMonth we want to elevate a collaborator of ours,
JDRF International, and their 2023 campaign. Their theme this year is ‘moving forward’, and they are uplifting voices of people living with #T1D.

They are advocating for new therapies and technologies to make living with #T1D better and safer. We are happy to collaborate with them on this goal as we advance our work on our investigational BioVascular Pancreas. https://lnkd.in/eM55GnAu

Come join our team! While the scientific professionals at Humacyte are advancing the future of regenerative medicine, our goals cannot be achieved without the critical support of other key business functions – including Finance, IT and Quality.
 
Among the positions currently available, we are seeking:
 
·      Manager, Quality Systems
·      Head of Information Systems Data Management and Integration
·      Accounts Payable Associate
·      Senior Validation Engineer
 
For more information about these opportunities and others, please visit humacyte.com/careers

Humacyte Presents Clinical Results of Human Acellular Vessel for Vascular Trauma

Thank you to everyone who stopped by our booth, learned more about our investigational Human Acellular Vessel™ (HAV™), or attended presentations where HAV clinical study results were featured at this year’s VEITHSymposium. We learned so much and feel energized for the work to come!

Laura Niklason, MD, PhD presenting our work in partnership with Frenova® on identifying the most challenging hemodialysis access patients at VEITHsymposium. #hemodialysis #regenerativemedicine

This week, Humacyte announced positive V005 Phase 2/3 clinical trial results of the investigational Human Acellular Vessel™ (HAV™) in the treatment of vascular trauma, as well as results from the treatment of wartime injuries in Ukraine – also known as the V017 trial. The data was presented by clinicians at VEITHsymposium  in New York City, a premiere annual gathering for vascular surgeons and specialists from around the globe. #VEITH2023
 
The 30-day results of a meta-analysis combining the two trials concluded the HAV demonstrated the following in comparison to historical synthetic graft benchmarks:
 
· Higher patency (blood flow) rates: HAV at 91.5% compared to 78.9% for synthetic grafts
· Lower infection rates: HAV at 0.9% compared to 8.4% for synthetic grafts
· Lower amputation rates: HAV at 4.5% compared to 24.3% for synthetic grafts
 
The combined V005 and V017 data will support Humacyte’s filing of a Biologics License Application [BLA] with the FDA before the end of 2023.
 
“These results indicate that the HAV performed well in this vascular trauma population who were at a very high risk of limb loss due to the nature of their injuries,” said Ernest E. Moore, MD, FACS, Director of Research at the Ernest E. Moore Shock Trauma Center at Denver Health, a clinical investigator in the V005 trial. “These results are most notable considering the high risk of wound infection and immediate availability of a durable conduit.”

Read more here: https://lnkd.in/gVHzTKYm

Are you attending VEITHsymposium  2023 at the New York Hilton Midtown? Please note the below talks of interest at this year’s event:

11/15 at 11:21 a.m. ET in the Gramercy Suite East, 2nd Floor: ‘Phase 2/3 Study For The Evaluation Of Safety And Efficacy Of HAV For Vascular Reconstruction In Patients With Limb Or Life Threatening Vascular Trauma’ by Dr. Charles J. Fox

11/16 at 7:14 a.m. ET in the Grand Ballroom East, 3rd floor: ‘Update On Tissue Engineered Biological Arterial Grafts (Humacyte) In Various Vascular Beds: How Well Are They Working In Patients: 6-Year Durability Data’ by Dr. Todd Rasmussen

11/18 at 3:38 p.m. ET in the Grand Ballroom West, 3rd floor: Our CEO, Laura Niklason, MD, PhD, will present ‘Hemodialysis Access: Which Patients Fare Well, Which Patients Fare Poorly’

More here: https://lnkd.in/e3eCwNav

Humacyte is at VEITHsymposium  in New York City, Nov. 14-18!

Come see us at booth 407 on the 3rd floor to learn more about our off-the-shelf, bioengineered Human Acellular Vessel™ (HAV™). Among the discussions scheduled this week, each of our pipeline innovations currently in clinical trials will be represented or supported – AV access, Peripheral Arterial Disease and vascular trauma repair.

We look forward to connecting with vascular surgeons at the event’s 50th anniversary and to be amongst world renowned specialists sharing the ‘latest advances, changing concepts in diagnosis and management, pressing controversies and new techniques’ in the world of vascular surgery.

Last weekend, the Brown Medical Entrepreneurship Society had the privilege of participating in the inaugural Yale Biomedical Engineering Conference 2023. 

We are incredibly thankful to the Yale Biomedical Engineering Society for extending the invitation to us and hosting a wonderful conference experience!

🎓 Student Attendees: It was an honor to connect with fellow students from universities around the Northeast. Forging new relationships and delving into the forefront of biomedical innovation and entrepreneurship was super rewarding.

👥 Guest Speaker and Panelist Events: We experienced amazing guest speaker and panelist events, including panels about medical school and biotechnology & VC. We would like to extend a special thank you to Benjamine Liu from TrialSpark and Laura Niklason, MD, PhD from Humacyte for inspiring us with your advice and wisdom. 

🔍 Research Symposium & Career Fair: Engaging with cutting-edge student biomedical research projects was a highlight of the conference experience. Thank you to the companies that participated (Pfizer, Cresilon, VETIGEL®, Revalia Bio, Medtronic, BioMed X Institute, Bexorg, Inc.) providing valuable insights into potential career paths. 

We're grateful for this enriching experience and excited about the future collaborations it has sparked! 🌐💡 #YaleBMEConference2023 #biomedicalengineering  #innovationjourney #entreprenership #biotechnology #venturecapital 

Here's to the transformative power of collaboration in the realm of healthcare and technology! 🎉

	Dec '19	Dec '20	Dec '21	Dec '22	Dec '23
revenue	6.19M -
cost of revenue			49K -
gross profit	6.19M -		-49K -
selling and marketing expenses
general and administrative expenses	16.27M -	12.01M 26.19%	21.13M 75.89%	22.88M 8.30%
selling general and administrative expenses	16.27M -	12.01M 26.19%	21.13M 75.89%	22.88M 8.30%	23.50M 2.68%
research and development expenses	75.60M -	54.08M 28.47%	61.34M 13.43%	63.26M 3.13%	76.55M 21.01%
other expenses		-1.49M -	-1.26M 15.29%	-1.56M 23.91%
cost and expenses	91.88M -	64.60M 29.69%	81.21M 25.71%	84.58M 4.15%	100.05M 18.29%
operating expenses	91.88M -	64.60M 29.69%	81.21M 25.71%	84.58M 4.15%	100.05M 18.29%
interest expense	2.30M -	2.20M 4.18%	4.35M 97.46%	6.20M 42.59%
ebitda	-81.00M -	-55.97M 30.90%	-136.98M 144.73%	-160.34M 17.06%	-100.05M 37.61%
operating income	-85.69M -	-64.60M 24.61%	-81.21M 25.71%	-84.58M 4.15%	-100.05M 18.29%
depreciation and amortization	4.69M -	8.63M 84.03%	-55.77M 746.33%	-75.77M 35.85%
total other income expenses net		-1.92M -	54.73M 2,944.65%	72.61M 32.67%	-10.73M 114.78%
income before tax		-66.52M -	-26.48M 60.20%	-11.96M 54.81%	-110.78M 825.83%
income tax expense		2.20M -	-64.01M 3,007.04%	-76.18M 19.01%
net income		-68.73M -	37.54M 154.62%	64.22M 71.09%	-110.78M 272.50%
weighted average shs out	2.89M -	103.00M 3,466.16%	39.97M 61.20%	103.05M 157.82%	103.42M 0.36%
weighted average shs out dil	2.89M -	103.00M 3,466.16%	39.97M 61.20%	103.05M 157.82%	103.42M 0.36%
eps	0 -	-0.67 Infinity%	0.94 240.30%	0.62 34.04%	-1.07 272.58%
epsdiluted	0 -	-0.67 Infinity%	0.94 240.30%	0.62 34.04%	-1.07 272.58%

COM:HUMACYTE

Humacyte, Inc.

Last Close

3.92

14/02 21:00

Market Cap

681.16M

Beta: -

Volume Today

1.48M

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