Executive Summary

Executive Summary 

Cardiovascular Disease (CVD) is the world’s leading chronic killer impacting more than one-third of the world’s population. Direct and indirect healthcare costs due to CVD is expected to grow to an estimated $1.5 trillion by 2030.  Among the top 150 developing nations worldwide, CVD is the largest health risk and cost.

Arterez is a Michigan bio-sciences group that has ascertained vascular pathophysiologies share common, multi-factorial ‘root’ causes, including damage to the endothelial glycocalyx, inflammation and oxidation and therefore require a complex, targeted therapeutic approach to enable curative and preventive outcomes.  

The company is pioneering a first-in-class, novel diagnostic and therapeutic platform including the Glycalyx Detritus Fingerprint™, a diagnostic technology for disease identification and classification and GlycoCardia™ for treatment monitoring as well as Embotricin™, a triple compound, small molecule, anti-thrombotic oral therapy targeting the primary root causes of CVD.  It has proven to prevent formation of emboli (clots) involving plaque regression and restoration of the glycocalyx and proved non-toxic up to 20x the effective dose in animal models.  

Arterez is currently conducting various translational animal studies utilizing 3 of Arterez’ 9 (patent issued) compounds in parallel to clinical studies with our patent pending 7-biomarkers of vascular disease, each clinically correlated to arterial plaque. Series A funding of $10 million dollars is required to complete biomarker algorithms and kit development, GLP scale-up manufacturing, CMC, formulation and stability, pre-IND, chronic toxicology, FDA IND and cGMP manufacturing.

First in-human proof of concept studies are expected to begin Q3-Q4 2022.  GAP, risk and cost analysis, development and regulatory timeline, Gantt and capital requirements have been carefully mapped to meet clinical objectives.

Company/Technology Summary:

1. Arterez, Inc. wholly-owns GlycoTrx, LLC (diagnostics) and ComboRx, LLC (therapeutics) for parallel product development while enabling flexibility.

2. Embotricin™ proved to prevent formation of emboli (clots) involving plaque regression and/or restoration of the endothelial glycocalyx and has demonstrated no toxicity up to 20x the effective dose in a 30-day tox study.

3. Dr. Tunac developed and synthesized 9 active compounds leading to the abbreviated factorial 3-drug combo design Embotricin™. Testing showed activity vs. other chronic diseases such as diabetes type 2 and arthritis.  These will also be developed following successful first in human trial/s vs. CVD.​

4. Two SBIR applications and research collaborations have been established.

5. $10M is needed to meet all requirements prior to clinical trial/s.  An estimated $15M will then be required to complete first in-human trials and position the company for targeted acquisition and public offering designed to provide shareholder liquidity and fund future platform research and development.

6. First in-human studies for Embotricin™ and therapeutic aide GlycoCardia™ against CVD indication/s are expected to begin in Q3 or Q4 of 2022 both in the US and/or other countries to be determined as we progress.

7. We are happy to provide a non-confidential deck to qualified investors as well as access to our proprietary data-room upon executed mutual NDA.

In conclusion:  The Arterez team led by Dr. J.B. Tunac can demonstrate a ‘root-cause’ correlative relationship between vascular diseases such as CVD, diabetes, arthritis and many others supported by our pre-clinical and clinical research as well as dozens of published studies just since 2017. More importantly, we believe our discoveries may be a profound scientific breakthrough that could lead to a new paradigm for the identification, characterization and treatment of CVD and other vascular pathophysiologies including curative and preventive outcomes.

Patent Portfolio:

1) Methods & compositions for reversing disruption of the glycocalyx, inflammation & oxidative damage,

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2) Biomarkers of vascular disease,

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3) Drug treatment & biomarker panel targeted to diseases due to multifactorial ontology of glycocalyx disruption,​

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4) International PCT methods & compositions filing

5) Thromboembolic animal model for CVD & inflammation (filing n process).

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Trademarks:

Arterez, Embotricin and GlycoGardia trademarks are approved with several others in process 

Intellectual Properties

Arterez (Draft) Publicatications

Publications

A) Endothelial Glycocalyx Biomarkers in Cardiovascular Disease

B) Curative and preventive treatment for cardiovascular disease (CVD)

C) Novel animal model for ventricular ejection fraction measured by MRI

Novel Technology Platform:

   Diagnostic Biomarker Panels  

       Glycalyx Detritus Fingerprint™ technology –

           Vascular disease identification & characterization

       GlycoCardia™ therapeutic aide –          

           Designed to monitor therapeutic efficacy for therapies

           targeting the endothelial glycocalyx and/or inflammation.

   Anti-Thrombotic Oral Therapies

       Embotricin™ triple compound oral therapy –

           Targets endothelial glycocalyx repair and maintenance,

           inflammation and oxidation              

Intellectual Properties:

    a. Drug Treatment and Biomarker Panel Targeted

        to Diseases Due to Multifactorial Ontology of

        Glycocalyx Disruption

    b. Biomarkers of Vascular Disease

    c. Methods and Compositions for Reversing      

        Disruption of the Glycocalyx, Inflammation and

        Oxidative Damage

   d.  (Draft) Animal Model for CVD and Inflammation

Clinical Targets:

   Embotricin™ IND/FDA indications:

        Hypertension  

        Pulmonary Hypertension

        Dialysis Fistula    

   Embotricin™ proof of concept/non-US indications:

        Heart Failure

        Cardiovascular Artery Disease

   GlycoCardia™ therapeutic aide

        Biomarker kit and algorithm validation

Pre-clinical Providers:

    DSK Biopharma – compound manufacturing

    Henry Ford Health System – translational studies

    Jackson Labs – thromboembolic animal model dev.

    Christal Pharmatech – analysis, formulation, stability

    Charles River Labs – toxicology studies

    Utah State University – corona virus pollutant study

    Clinical Network Svcs. – GAP analysis/AUS dev plan

Clinical Providers:

    Transhit-Bio – clinical bio-samples sourcing

    Arbor Assays – ELISA serum & plasma studies

    Dr. Dave Feichner – modeling, data analysis

    Nucleus Network – clinical investigator (AUS)

    4D BioNexus, Dr. Bonnie Weiner, GreenChem –    

    licensing, regulatory & IND/clinical strategy

Legal and Advisory:

    Weaver Austin Villeneuve & Sampson LLP

        Intellectual Properties 

    Bodman PLC

       Corporate filings, offering documentation

    Varnum LLP

       Trademarks, Publishing

    Garrett & Bachand PC     

       General Counsel

   Croskey Lanni

       Corporate Accounting

   ABA Consulting

       Corporate Advisory (AUS)

2012-2017

2018-2023

Dr. Josephino Tunac launched

Farmaceutix, LLC (FTX)

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R&D for anti-embolic bio-

markers and compounds*

Rationally synthesized 9

synthetic compounds 

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3x combo proved to prevent 

& reverse arterial plaques

New studies launched with

natural mouse, biomarkers

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Compounds/methods, 

biomarker patents filed

Surrogate markers identified for 

development/testing of compounds

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Developed natural arterial 

plaque mouse model

Combo drug proved non-toxic

up to 20x the effective dose

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Engaged firm to assist with platform

development and funding 

FTX continues testing & development 

of additional intellectual properties

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Patent filings amended, audit completed, development pathway established 

Arterez launched, FTX IP

assigned, team developed

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Website built, new IP filed &

issued, providers engaged

IRB studies, compounds to GLP, SBIR/Omnimus grants

ELISA & animal studies, GAP

analysis, plan updated, series A 

Phase I healthy, limited 1B

studies vs CHD, HF & HTN

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IP valuation, engage licensing 

partner/s and/or suitors

Seed raise, biomarkers added, 

ELISA & HFHS** studies engaged

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Website built, new IP filed &

issued, providers engaged

Formulation, optimization, stability,

chronic toxicology, pre-IND

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Series B, patient recruitment, 

Australia submissions, IND/IRB filings

Complete co-dev, licensing or other

for diagnostic and therapy

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Consider IPO to continue 

platform development

Development Timeline

Scientific Breakthrough

Historical development of antibiotic targeting microorganisms leading to cure of infectious disease. An equivalent approach is to target endothelial glycocalyx to cure CVD by an antiembolic™ mechanism.