What is Conexeu Sciences, Inc.'s stock symbol?

Our stock is traded on the Nasdaq under the symbol CNXU.

When was Conexeu Sciences, Inc. incorporated?

November 2, 2022

Where is Conexeu Sciences, Inc. located?

50 West Liberty Street
Suite 880
Reno, NV 89501

When is Conexeu Sciences, Inc.'s fiscal year end?

October 31st

Who is Conexeu Sciences, Inc.'s transfer agent?

Nevada Agency and Transfer Company
50 West Liberty Street
Suite 880
Reno, NV 89501
T: 775-322-0626
info@natco.com

Who is Conexeu Sciences, Inc.'s independent auditor?

Adeptus Advisory Group, LLC
733 State Route 35
Ocean, NJ 07712
+1 (732) 595-3115

Who is Conexeu Sciences, Inc.'s legal counsel?

McMillan LLP
1055 West Georgia St., #1500
Vancouver, V6E 4N7 BC
Canada
+1 (604) 689-9111

What is Conexeu Sciences?

Conexeu Sciences is a Nasdaq-listed company, ticker CNXU, developing CXU™, a material a surgeon would place into a wound or a soft-tissue defect during a procedure. It goes in as a liquid, fills the space whatever its shape, and sets into a solid at body temperature in about ten minutes. It is designed to act as a temporary framework the body's own cells move into, and to break down over time as the body replaces it. Conexeu has no product on the market. CXU™ is investigational, has not been cleared or approved by the FDA, and is not available to patients.

Who leads Conexeu Sciences?

Miles Harrison is President and Chief Executive Officer, appointed in November 2025. Dr. Claudia Chavez-Munoz, a co-founder, is Chief Scientific Officer. Dr. Brian Pilcher is Chief Medical Officer. Steve Inouye is Chief Financial Officer. David Bogart, a co-founder, is Chief Commercial Officer and a director. The Board expanded from six directors to nine in June 2026.

What is CXU™?

CXU™ is an injectable material designed to give the body a temporary structure to rebuild into. Because it is placed as a liquid, it can fill deep or irregular spaces that flat sheets and powders do not fill evenly. At body temperature it sets into a gel in about ten minutes. In technical terms it is a thermosensitive, collagen-based extracellular matrix scaffold. Extracellular matrix, or ECM, is the natural structural network that surrounds cells and holds tissue together. CXU™ is investigational and has not been cleared or approved for any use.

How is CXU™ designed to work?

CXU™ is designed to work physically, not chemically. The Company's filings describe the mechanism as structural rather than pharmacologic, which means it is not intended to release a drug or trigger a biological reaction. It fills the space, sets in place, and is intended to act as a framework the body's own cells migrate into and blood vessels grow through as part of normal healing, breaking down gradually as the body replaces it with its own tissue. This is what the Company expects based on laboratory and animal work. It has not been shown in people.

Who would use CXU™, and on which patients?

If CXU™ is ever cleared, the users would be surgeons and wound clinicians. Conexeu has described its early focus as burns, trauma injuries, and deep or complex wounds, the kind where the wound bed is uneven and difficult to cover with a flat dressing or sheet. The Company has said it intends to approach burn units, trauma wards, and specialist wound care clinics first. No indication has been cleared, and the FDA determines what a cleared product may be used for.

Has CXU™ been tested in humans?

No. Everything known about CXU™ comes from laboratory work and animal studies. Conexeu has not run a human clinical trial. The Company states in its filings that animal biology differs from human biology and that these results may not predict how the material performs, or how safe it is, in people. Anyone evaluating Conexeu should treat the human question as open.

What research supports CXU™?

Eleven peer-reviewed papers published between 2011 and 2023, in journals including Acta Biomaterialia, Tissue Engineering Part A, Journal of Burn Care and Research, Advances in Wound Care, and Gels. The work covers laboratory testing and animal studies in mice, rats, rabbits, and pigs. It was carried out over more than a decade at the University of British Columbia, and Conexeu states that it did not fund that research. Conexeu acquired the underlying intellectual property after the company was formed in 2022.

What is P.R.O.O.F.™?

P.R.O.O.F™ stands for Performance and Regeneration Outcomes of Flowable Collagen. It is a twelve-month animal study programme that Conexeu announced as complete on July 7, 2026. The Company reported that it met the objectives it had set in three areas: a small-volume facial model, a larger-volume model of about 200 cc placed under the skin, and how the material performs when injected. Conexeu also stated what P.R.O.O.F™ is not. It is not a clearance, not a commercial launch, and not a human result. The detailed findings are being held for publication in a peer-reviewed journal, the Company has said clinical significance has not been established, and the volumes used do not establish a safe or appropriate dose for people.

Is CXU™ FDA approved?

No. CXU™ is not approved by the FDA. It is in preclinical development, which means it has not yet been tested in people, and it has not been cleared or approved for sale anywhere in the world. Approved and cleared are two different FDA outcomes, explained in the next answer.

Has CXU™ been cleared by the FDA?

No. Neither word applies to CXU™ today. Clearance comes through a process called a 510(k) and is used for most moderate-risk devices. Approval comes through a longer process called a PMA and is used for higher-risk devices. Conexeu expects to seek clearance by the 510(k) route for its first product. The FDA decides which route a product falls under.

Has Conexeu submitted anything to the FDA yet?

No. The Company states on its website that CXU™ has not been submitted to or reviewed by the FDA. On June 8, 2026 Conexeu reported progress on manufacturing scale-up and regulatory work for its wound care programme, described as intended to support a planned future 510(k) submission. A submission is not a clearance, and submitting does not guarantee the FDA will agree.

What is Conexeu's lead regulatory program?

Wound care. It is the first product Conexeu intends to take to the FDA, by a 510(k). A 510(k) is the route for a device similar enough to something already legally sold that the FDA can review it without requiring a new human trial, which is why it is faster and less expensive than the alternative. Review usually takes three to twelve months and can take longer. If cleared, it would be the first product the Company could sell. Aesthetic uses would likely need the longer route, which does require studies in people.

What happens if the FDA says no?

The FDA can decide a device is not substantially equivalent to the product it was compared against. If that happens, the device is automatically treated as higher-risk, and the company must either go through the longer approval process or ask the FDA to reclassify it. Either route costs more and takes longer. The FDA can also ask for more data before deciding, or decide from the start that a different route applies. These risks are set out in the Risk Factors section of the Company's filings.

Is CXU™ available to patients or doctors today?

No. CXU™ cannot be bought and is not used in patient care. Conexeu does not sell it and does not supply it to clinics. Availability would depend on FDA clearance or approval first, and then on the Company completing manufacturing and quality requirements. There is no timeline for that.

What markets is CXU™ being developed for?

Five. Wound care is first, and is the only one with a regulatory programme underway. The other four are medical aesthetics, restoring soft-tissue volume; oral health, soft tissue in the mouth; animal health, wound care for animals; and 3D-printed tissue. Each of the four would need its own FDA authorisation and its own submission. Conexeu states that the opportunity in all of them remains uncertain and depends on safety and performance being demonstrated, on regulatory outcomes, and on whether clinicians adopt the product.

How is CXU™ different from dermal fillers and biostimulators?

The three are designed to do different jobs. A dermal filler is designed to occupy space and add volume. A biostimulator is designed to prompt the body's own response. CXU™ is designed to supply structure, a temporary framework intended to be filled in by the body's own cells. These are differences in design intent, drawn from laboratory and animal work. No study has compared CXU™ against another product in people, and no performance advantage has been established.

What is the GLP-1 opportunity?

People who lose a large amount of weight on GLP-1 medications often lose facial and body soft-tissue volume along with the fat. Conexeu's argument is that today's injectables were designed for small-volume facial correction rather than for restoration at that scale. The Company cites a Boston Consulting Group estimate that GLP-1-related revenue for aesthetic providers could grow from around $0.7 billion to $2.0 billion within five years. That is a description of a market, not a product claim. CXU™ has no aesthetic indication and is not approved for aesthetic use.

What is B.R.E.A.S.T.™?

B.R.E.A.S.T.™ is a research programme aimed at breast reconstruction after mastectomy. Today a patient generally chooses between a permanent implant or surgery that moves tissue from elsewhere on her own body. B.R.E.A.S.T.™ is a 3D-printed version of the CXU™ material, designed as a temporary structure the body would gradually replace with its own tissue rather than a permanent object. On May 27, 2026 Conexeu announced a preclinical programme with the Wake Forest Institute for Regenerative Medicine to study how well it integrates, how long it lasts, and how it breaks down. This is animal-stage research. No FDA submission has been made and there is no product. The name stands for Bio-Regenerative Ergonomically Architected Smart Tissue™.

What intellectual property does Conexeu own?

Conexeu owns the CXU™ patents outright. It bought them rather than licensing them, so there are no royalties or licence fees payable to anyone else, and no third party has a claim on revenue if a product is ever sold. The patents cover both the formulation itself and the methods of using it, which is broader than covering the recipe alone. Patents are a defence against copying. They do not indicate that a product works, or that a regulator will authorise it.

What are the next major milestones?

The next milestone is Conexeu's first FDA submission, a 510(k) for wound care. Alongside it the Company is working on manufacturing scale-up, which means contracting a manufacturer and validating production to the standard the FDA requires. After any clearance it would apply for a reimbursement code, the billing code that allows hospitals to be paid for using a product. Separately, the B.R.E.A.S.T.™ programme continues in animal research at Wake Forest. Target dates and cost estimates are set out in the Company's SEC filings. These are plans, not commitments, and they can change.

Why does this take so long?

Medical devices cannot be sold until a regulator authorises them, and authorisation depends on evidence that takes years to generate. Conexeu's first step is a 510(k), which the FDA usually reviews in three to twelve months and sometimes longer, and that review only begins once manufacturing, testing, and documentation are complete. Aesthetic uses would need studies in people, which take longer again. There will be long stretches with no announcements. That is normal at this stage and is not by itself a sign that anything is wrong.

What are the main risks?

Conexeu is a preclinical company with no product, no revenue, and a stated need for more capital. The main risks are that CXU™ never receives clearance or approval, that the FDA requires a longer or more expensive route than the Company expects, that results in animals do not carry over to people, that the capital required to continue is not available on acceptable terms, and that timelines slip. The full list is in the Risk Factors section of the registration statement and the periodic reports, and it should be read in full before making any investment decision.