Humacyte Inc (HUMA) ニュース

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.
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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.
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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

[color=red][/color]

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

$HUMA It's all in the family:
Mr. Dougan is married to Dr. Niklason and Mr. Dougan has sole voting and dispositive power over the shares held by Ayabudge LLC. By virtue of these relationships, Mr. Dougan may be deemed to share beneficial ownership of the securities held of record by Dr. Niklason, The Niklason Living Trust and Ayabudge LLC.

Great color!  Time for the fda to let this run

Department of Defense's priority designation is a strong tell about the future of civilian use.
"Humacyte is currently evaluating the HAV in a phase 2/3 clinical trial in vascular trauma for use as a vascular replacement to restore blood flow to a limb when saphenous veins or synthetic grafts are not feasible. The HAV has received priority designation for the treatment of vascular trauma by the United States Secretary of Defense."
Sept 22, 2023 article
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after approval expect a quick order from DOD

A RMAT designation allows for accelerated approval based surrogate or intermediate endpoints. RMAT goes beyond breakthrough therapy features by allowing for accelerated approval of drugs based on surrogate endpoints. A surrogate endpoint is a biomarker that substitutes for a direct endpoint, such as clinical benefit.
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FDA has awarded Humacyte for two indications.

HUMA under $6

Has ANYTHING changed?
August 9, 2024 “We received a call from FDA CBER leadership this afternoon apologizing to us and stating that additional time was required for review.”

This company has a lot going for it, that is for sure

Humacyte up today on genuinely positive SA piece.
https://seekingalpha.com/article/4722917-humacyte-navigating-the-fda-uncertainty-and-atevs-potential

Very nice!

Wynn for the win...my horse is coming in

Great to hear from you. I bought a bunch of calls for 5 cents here for he t week expiry. I can only hope Christmas comes early…

How are ya bud...been busy...Sept sucks for stocks...only holding some WYNN calls until interest rate cuts on the 18th...have to remember to ck in once in here a while lol...hope all is good with you...talk again soon

You still around? I have a feeling go time could be soon but fda always has em all by the balls ….

Likey or dislikey? Just waiting on fda. Tech is there, proven and safe. A lot of limbs/lives saved in Ukraine because of humacyte

HUMA under $7

Their product is amazing. Will help so many people

Great stuff and that is what I see too. Thanks!

I sold my options here and bought shares...they're cheap