21
INVESTOR PRESENTATION 10/31/2022 www.fortisoncology.com

Fortis Oncology - Nanomedicine Solutions

Embed Size (px)

DESCRIPTION

Targeted nanoparticle tumor ablation. Multi-walled Carbon Nanotubes (MWCNT) are designed with internal antennae tuned to a specific Near Infrared (NIR) laser frequency, which when activated, oscillate at high speeds, generating thermal energy (heat) sufficient to cause cell apoptosis. Using targeting probes, the MWCNT only seek out, attach to, and within, specific cancer cells. The NIR laser is non-invasive, and does not injure the skin. The MWCNT can also be conjugated with probes for very specific imaging for diagnostics purposes using existing MRI technology.

Citation preview

Page 1: Fortis Oncology - Nanomedicine Solutions

INVESTOR PRESENTATION 04/13/2023

www.fortisoncology.com

Page 2: Fortis Oncology - Nanomedicine Solutions

FORTIS ONCOLOGY: NANOTHERMAL MEDICAL DEVICE PRODUCTS TO ERADICATE CANCER

Page 3: Fortis Oncology - Nanomedicine Solutions

THE COST OF CANCER IS HIGH. EACH OF US HAS BEEN TOUCHED WITH CANCER IN OUR LIVES; A MOTHER, FATHER, SIBLING, FRIEND. IT IS A LARGE AND GROWING MARKET AND HUGE HEALTHCARE ECONOMIC BURDEN

Worldwide, there are more than 12.5M new cancer diagnoses each year, and that figure continues to climb.

The total cost of cancer have been estimated to be as high as $895 billion (US) worldwide.

04/13/2023 3

CANCER TODAY

http://www.cancer.org/

Page 4: Fortis Oncology - Nanomedicine Solutions

Confidential

OUR MISSIONTo bring advanced, nanothermal products to market approval that not only destroy cancer, but spare healthy tissue, without the side effects seen in conventional therapies and in doing so, build a sustainable, profitable business. 04/13/2023 4

Page 5: Fortis Oncology - Nanomedicine Solutions

HISTORY OF NANOFORTIS ONCOLOGY• Founded in 2013 in Winston-Salem, NC

• Technology developed by leading materials science and clinical researchers at Wake Forest University. Fortis holds exclusive licenses to key patent estate

• Product development company utilizing advanced light-absorbing nanoparticles to thermally ablate solid tumors

• More than 5 years of preclinical work completed, including in vitro and in vivo proof-of-concept demonstration

04/13/2023 5

Frank M. Torti, M.D., M.P.H Executive Vice President for Health Affairs for the University of Connecticut Health Center and the eighth Dean of the UConn School of Medicine.

Torti joined the Health Center from Wake Forest University School of Medicine where he served as Vice President for Strategic Programs, Director of the Comprehensive Cancer Center, and Chair of the Department of Cancer Biology. In addition, he previously served as the former Principal Deputy Commissioner, Chief Scientist, and then Acting Commissioner of the U.S. Food and Drug Administration.

Page 6: Fortis Oncology - Nanomedicine Solutions

“CANCER NANOTECHNOLOGY: SMALL, BUT HEADINGFOR THE BIG TIME”

NATURE REVIEWS DRUG DISCOVERY

NATURE REVIEWS DRUG DISCOVERY 6, 174-175 (MARCH 2007) | DOI:10.1038/NRD2285

04/13/2023 6

Page 7: Fortis Oncology - Nanomedicine Solutions

Confidential

TECHNOLOGY

04/13/2023 7

Page 8: Fortis Oncology - Nanomedicine Solutions

HOW IT WORKS

04/13/2023 8

Page 9: Fortis Oncology - Nanomedicine Solutions

TECHNOLOGY DEVELOPMENTMILESTONES

04/13/2023 9

Page 10: Fortis Oncology - Nanomedicine Solutions

HOW IS FORTIS ONCOLOGY DIFFERENT?• Many options to achieve maximal thermal ablation and tumor

cell death:

• MWCNT with or without metals;

• a variety of geometries (MWCNT cylinders [straight, bent, folded] or nanospheres;

• doped with contrast agents;

• functionalized with API and/or antibodies (for targeted delivery to cancer cells)

• functionalized for embolization of tumor.

• Passive or active targeting

• Novel nanomaterials which are soluble

• No use of gold nanoparticles thus relieving regulatory burden other groups who use these face

• Non-invasive, more efficacious; utilizes NIR or RF—no probes, more thorough tumor margin ablation

• Significant preclinical studies in large animals in vivo studies demonstrate primary tumor and cancer stem cell ablation

• Products for cancer therapy will follow medical device approval path, not as a drug—reduced time to approval and lower regulatory risk

04/13/2023Confidential 10

ContrastAgent

TargetedDelivery

CytotoxicAgent

Page 11: Fortis Oncology - Nanomedicine Solutions

Confidential

THE BUSINESS

04/13/2023 11

Page 12: Fortis Oncology - Nanomedicine Solutions

THE FORTIS ONCOLOGY TEAMPaul Rohricht, MS, MBA Chief

Executive Officer

• Serial entrepreneur, co-founder of Revivicor, Inc. (acquired by United Therapeutics); co-founder of Symphogen, Inc.

• $500M+ in transactions.

• Formerly CEO, Vedere LLC; CEO, Keractive Beauty LLC; COO Keraplast Technologies, Inc.; Vice President Corporate Development ICx Technologies Inc.; Symphogen A/S, Revivicor Inc., and PPL Therapeutics.

• 1 issued US Patent, 4 pending

• Wharton MBA

• Associate Dean, Dean's Office Associate Professor, Surgery, Translational Science Institute, Wake Forest Baptist Medical.

• Expert in HIPEC Therapy, surgery, oncology treatment.

• Lead or co-author on key academic papers which underpin the Fortis Oncology technology.

• Co-inventor on key applications of Fortis Oncology IP.

• Assistant Professor, Plastic & Reconstructive Surgery, Wake Forest Medical School.

• Expert in cancer/oncogenesis, drugs/therapeutic agents/ pharmaceuticals, engineering/bioengineering, device development, preclinical development.

• Lead or co-author on key academic papers which underpin the Fortis Oncology technology.

• Lead and/or Co-inventor on key applications of Fortis Oncology IP.

04/13/2023 12Confidential

John Stewart, MD Chief Medical Officer

Nicole Levi-Polyachenko, PhD Chief Scientific Officer

Page 13: Fortis Oncology - Nanomedicine Solutions

BUSINESS MODEL• Develop a suite of medical devices specific to a particular

disease area;

• License those devices to key players;• Diagnostic imaging contrast agents

• Prospective licensees include: Potential Licensees: GE Healthcare, Philips Healthcare, Siemens Healthcare, Toshiba Medical Systems Corporation, Hologic, Inc., Hitachi Medical Corporation

• Cancer therapeutic medical devices

• Prospective licensees (in addition to Big Pharma/Biotech) include:

• Image-guided RFA: AngioDynamics, Boston Scientific and Covidien;

• Cryoablation: Endocare, a division of Healthtronics, Inc., Galil Medical;

• Microwave Ablation: Evident Microwave Ablation (Covidien);

• High-intensity focused ultrasound (HIFU): InSightec Ltd. (device works with General Electric (GE-) based MRI systems and therefore GE is a potential licensee

04/13/2023 13

Page 14: Fortis Oncology - Nanomedicine Solutions

MARKET OPPORTUNITY

04/13/2023 14

Page 15: Fortis Oncology - Nanomedicine Solutions

MARKET OPPORTUNITY

Cancer Diagnostic Imaging

04/13/2023 15

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 $-

$500,000

$1,000,000

$1,500,000

$2,000,000

$2,500,000

MRI Diagnostic Contrast Agent Market Size ($'000M); 5% CAGR

http://www.bccresearch.com

http://www.cancer.org

2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 $-

$50,000,000

$100,000,000

$150,000,000

$200,000,000

$250,000,000

$300,000,000

$350,000,000

Market Size, Worldwide Cancer Therapy Market Size ($'000M), 18.5% CAGRHIPEC

Skin CancerBreast CancerKidney CancerProstate CancerSoft Tissue NeoplasmsBone NeoplasmsBreast CancerBrain Cancer

Page 16: Fortis Oncology - Nanomedicine Solutions

Confidential

COMPETITION

• Thermal Abalation

• Image-guided RFA: AngioDynamics, Boston Scientific and Covidien;

• Cryoablation: Endocare, a division of Healthtronics, Inc., Galil Medical;

• Microwave Ablation: Evident Microwave Ablation (Covidien);

• High-intensity focused ultrasound (HIFU): InSightec Ltd. (device works with General Electric (GE-) based MRI systems and therefore GE is a potential licensee;

• Laser Interstitial Thermal Ablation

• Irreversible electroporation (IRE)

• Nanomaterials

• BSD

• Magforce AG

• Nanospectra

• Pharma/Biotech

• All the major players: Roche/Genentech, Pfizer, Merck, BMS, Lilly, GSK, Sanofi, Takeda.

• Top Cancer Drug Sales 2011: Rituxan - $3 billion; Avastin - $2.66 billion, Herceptin - $1.66 billion, Gleevec - $1.51 billion, Eloxatin - $1.2 billion, Alimta - $1.04 billion, Erbitux - $703.3 million, Velcade - $692.7 million, Xeloda - $647.6 million, Tarceva - $564.2 million

04/13/2023 16

http://www.fiercepharma.com

Page 17: Fortis Oncology - Nanomedicine Solutions

PRODUCT DEVELOPMENT PLAN

Diagnostic Imaging

• Device production for MRI cancer imaging

• Clinical Trials

• Regulatory Consulting (outsourced)

04/13/2023 17

Tumor Thermal Ablation• HIPEC device production• Clinical Trials• Regulatory Consulting (outsourced)

Product Development, Tumor Thermal Ablation• Device production for interperitoneal solid

tissue cancer ablation (gastrointestinal, kidney, pancreas

• Clinical Trials• Regulatory Consulting (outsourced)

Page 18: Fortis Oncology - Nanomedicine Solutions

REGULATORY STRATEGYA regulatory framework is already in place

Clinical trials are underway throughout the world for a variety of indications using nanomaterials in cancer

04/13/2023 18

Page 19: Fortis Oncology - Nanomedicine Solutions

CAPITAL RAISE

Use of Proceeds• Diagnostic Imaging

• Device production for MRI cancer imaging

• Clinical Trials

• Regulatory Consulting (outsourced)

• Tumor Thermal Ablation

• HIPEC device production

• Clinical Trials

• Regulatory Consulting (outsourced)

• Product Development, Tumor Thermal Ablation

• Device production for interperitoneal solid tissue cancer ablation (gastrointestinal, kidney, pancreas)

• Clinical Trials

• Regulatory Consulting (outsourced)

• Ongoing IP prosecution and license obligations

• Staff, General and Administrative (1 FTE, 2 part time FTE)

$5M

04/13/2023 20

Page 20: Fortis Oncology - Nanomedicine Solutions

Products• Products to diagnose and treat:

• Skin, kidney, prostate, soft tissue neoplasms, bone neoplasms

• Advanced MRI contrast agents

• Thermal ablation of cancer devices

• Thermal ablation of cancer with delivery of drugs

Team

• Paul Rohricht, MS MBA, CEO• Serial entrepreneur, co-founder of Revivicor, Inc.

(acquired by United Therapeutics); co-founder of Symphogen, Inc.; $500M+ in transactions.

• John Stewart, MD, CMO• Associate Professor, Surgery, Comprehensive

Cancer Center, Wake Forest Baptist Health

• Nicole Levi-Polyachenko, PhD, CSO• Assistant Professor, Plastic & Reconstructive

Surgery, Wake Forest Medical School

Technology

• MWCNT with various geometries (tube, bent, curved, folded)

• MWCNT + iron and/or other metals

• Functionalized MWCNT + branched structures for delivery of APIs

• Microparticle compositions

• MWCNT + nitrogen and/or boron

IP

• US 8,252,772 “Hyperthermic Technologies and Uses Thereof”

• US 8,501,233 “Compositions and Methods for Treating Cancer”

• Several other patents pending including “Novel Embolizing Therapy for the Ablation of Solid Tumors”

04/13/2023 21

BUSINESS SUMMARY

Page 21: Fortis Oncology - Nanomedicine Solutions

CONTACT

04/13/2023 22

Paul Rohricht MS MBA; CEO Fortis Oncology

+1 704.249.8342

[email protected]

www.fortisoncology.com