Humacyte Inc (HUMA) 시세

The first FDA approval lends validation to early stage trials

Nov. 18, 2024

In the preclinical study, the sdATEV was implanted between the aorta and right coronary artery (RCA) in five baboons to simulate a CABG procedure. Animals were followed for six months after sdATEV implantation and all sdATEVs maintained patency throughout the study. The baboon study provided an effective model for demonstrating the feasibility, mechanical durability and capacity for host-cell remodeling of the sdATEV for CABG.

“Our results show that the sdATEV not only supports coronary blood flow but also host recellularization and adaptive remodeling in a challenging preclinical surgical model,” said Dr. Kirkton

HUMA under $2

HUMA, under $2

Bloomberg US Approved Device for Battlefield Injuries Despite Serious Risks, Former FDA Reviewer Says
https://www.bloomberg.com/news/articles/2025-03-25/us-approved-device-for-battlefield-injuries-despite-serious-risks-former-fda-reviewer-says

JAMA Bioengineered Human Arteries for the Repair of Vascular Injuries
https://jamanetwork.com/journals/jamasurgery/fullarticle/2826564

FDA Clinical Review Memo - Symvess
https://www.fda.gov/media/185229/download?attachment

HUMA, recent 52 week low

I’m a LT holder…..
D. Boral Capital says the selloff in shares of Humacyte (HUMA) following the company’s $50M capital raise is a buying opportunity. While the stock weakness reflects dilution concerns, the additional capital significantly strengthens Humacyte’s financial position, the analyst tells investors in a research note. With its FDA-approved cellular tissue-engineered vessels “poised to revolutionize vascular trauma,” D. Boral views the current pullback as an opportunity to accumulate shares. It keeps a Buy rating on Humacyte with a $25

D. Boral Capital says the selloff in shares of Humacyte (HUMA) following the company’s $50M capital raise is a buying opportunity. While the stock weakness reflects dilution concerns, the additional capital significantly strengthens Humacyte’s financial position, the analyst tells investors in a research note. With its FDA-approved cellular tissue-engineered vessels “poised to revolutionize vascular trauma,” D. Boral views the current pullback as an opportunity to accumulate shares. It keeps a Buy rating on Humacyte with a $25

Specific information based from the NYT article? That combined with the announced dilution makes for a bad shareholder's day.

Shortly after FDA approval, Humacyte began receiving requests for quotations for Symvess from hospitals. Twenty-one hospitals have already initiated the VAC approval process, with additional hospitals expected to commence the process. These hospitals are a mix of leading trauma centers that were participants in Humacyte clinical studies combined with institutions newly introduced to Symvess.

nope

Good morning TT. Are you holding a position or trading shares?

HUMA READY FOR 4.00

HUMA RAMPING

Commercial launch of Symvess. Feb. 26, 2025
https://humacyte.gcs-web.com/news-releases/news-release-details/humacyte-announces-commercial-launch-symvesstm-acellular-tissue

HUMA BACK IN PLAY

Humacyte and Pluristyx Partnership will aim to normalize glucose levels in diabetic patients.
https://humacyte.gcs-web.com/news-releases/news-release-details/humacyte-and-pluristyx-announce-gene-editing-partnership-support

Humacyte plans to file an IND for the small-diameter (3.5mm) acellular tissue engineered vessel (sdATEV) in coronary artery bypass grafting (CABG).
https://investors.humacyte.com/news-releases/news-release-details/humacyte-announces-planned-ind-filing-2025-support-first-human

In the preclinical study, the sdATEV was implanted between the aorta and right coronary artery (RCA) in five baboons to simulate a CABG procedure. Animals were followed for six months after sdATEV implantation and all sdATEVs maintained patency throughout the study. The baboon study provided an effective model for demonstrating the feasibility, mechanical durability and capacity for host-cell remodeling of the sdATEV for CABG. After implantation, the sdATEV was observed to recellularize with host cells and remodel to form a multi-layered tissue including transanastomotic neomedial tissue that effectively reduced the initial size mismatch with the RCA. The neomedial tissue observed at six months was predominantly composed of quiescent contractile smooth muscle cells under a lining of functional endothelial cells.
“Our results show that the sdATEV not only supports coronary blood flow but also host recellularization and adaptive remodeling in a challenging preclinical surgical model,” said Dr. Kirkton.
.
Functional organs from the Humacyte scaffold without autoimmune complications. No idea where the valuation would be.

In 2010, the HUMA co-founder and CEO, Dr. Laura Niklason and her colleagues were able to successfully produce an engineered rat lung that could inhale and exhale carbon dioxide.

Her work on lab-grown lungs was recognized as one of the top 50 most important inventions of 2010 by Time magazine.[3][4] Niklason was included on Fortune’s “Digital Health Care Leaders” list in 2017 for her work in regenerative medicine.

en.wikipedia.org/wiki/Laura...

Acellular Tissue Engineered Vessels - ATEV
FDA approved as safe and effective in human use

Vascular Trauma - big step in validation of ATEV and future indications

* Dialysis (AV access) - phase III study completed and proved safe and effective
* Peripheral Artery Disease - just a matter of time for approval as same technology for vascular Trauma
* Coronary Artery Bypass Grafting (CABG) - same technology works here as in vascular Trauma. Around 400,000 patients yearly.
.
This would all be low hanging fruit now that ATEV is FDA approved and are just a matter of patience. The technology has potential well beyond ATEV.

Very nice DD

1. Assigned Priority Review Designation by Secretary of Defense under Law 115-92 which is used for military purposes. mrdc.health.mil/index.cfm/a...

2. In the latest Humacyte slide deck it says "Humacyte expects DOD to stockpile for deployment to sites of conflicts.

3. The Phase 2/3 clinical data included wartime injuries in both Ukraine, and Israel the two largest warzones right now.

4. In this article from 10/16/24 CEO Laura says the Department of Defense "Sponsored some of their trials". ncchamber.com/2024/10/16/du...

5. Received RMAT designation only given to products with an "unmet need" in the field fda.gov/vaccines-blood-biol....

6. The DOD gave them $1,000,000 Grant in 2017 Through the Medical Technology Enterprise Consortium (MTEC).

7. The DOD gave them $3,400,000 Contract Award through the BAA to support the Phase 2 studies. biospace.com/humacyte-award...

In 2010, the HUMA co-founder and CEO, Dr. Laura Niklason and her colleagues were able to successfully produce an engineered rat lung that could inhale and exhale carbon dioxide.

Her work on lab-grown lungs was recognized as one of the top 50 most important inventions of 2010 by Time magazine.[3][4] Niklason was included on Fortune’s “Digital Health Care Leaders” list in 2017 for her work in regenerative medicine.

en.wikipedia.org/wiki/Laura...

Humacyte price target raised to $17 from $15 at Benchmark. Looking forward to 2025. Insider buying and pt upgrades bode well for positive moves going forward.
GLTA
3

It's gonna go .Interest is picking up and more buys than sells

HUMA under $5

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Wainwright analyst Vernon Bernardino raised the firm's price target on Humacyte (HUMA) to $15 from $12 and keeps a Buy rating on the shares after the FDA granted full approval for Symvess for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb ...

Let's push through the $4.80 wall!

awww so you're out. Looks difficult for afternoon move up

We're trading substantially below days VWAP....

Lunch time pull back. Do you anticipate afternoon trend back up? Or do we call it one and done!

EXITED ON THAT PUSH BOTTOM BOUNCE

Love having you back.  You are one of the smartest traders out there.  Unfortunately you like to be mean to less intelligent people 😝.  Anyways, how far do you think this could run?  Thanks

Now, reality bites.
Cash and time to ramp up.
Will vascular surgeons switch from the old and familiar?
TBD.

HUMA READY TO RUN AGAIN

Finally!

Approved
https://investors.humacyte.com/news-releases/news-release-details/humacyte-announces-fda-approval-symvesstm-acellular-tissue

Today is Dec 9th. Dec 9th marks 10 months since HUMA's PDUFA application.
FDA has performance goals. For regular PDUFA applications the goal is 90% within 10 months.
FDA performance goals: https://www.fda.gov/media/151712/download

I don't know of any. But you can roll your own using eg. Amazon Transcribe.

Is there a transcript available anywhere? Have not had any success finding a transcript

Good news that they don't pull the plug.  This will be accepted by RFK less than a month in office 

The FDA is the wall. She can't say anything.
Adding that FDA has performance goals which, in this case, are not being met.

You say ok.  So everything is moving forward with the fda still?  Thanks 

Webcast OK. Direct questions and direct answers.

Supplemental BLA. Discussed during webcast.
Replay is up. https://investors.humacyte.com/news-events/events-and-presentations

If they are selling for any other reason than to keep it below 5%, there will be a ton of lawsuits....

Stonewalled.
The family sold with the excuse to reduce below 5% holding. That's no excuse at all. They're still insiders and know exactly what's up.

Crazy