Chelation Partners is solving sepsis with DIBI, and iron binding polymer that augments a natural defense to infections. It slows infections and the over-reaction of the immune system known as cytokine storm, which kills patients. It is immune to antibiotic resistance and effective against a very broad spectrum of disease causing microorganisms.
1. A New Hope for Antimicrobial
Resistant Infections and Sepsis
DIBI - an anti-infective, anti-inflammatory iron binding polymer
mweickert@chelationpartners.com 1
Michael J. Weickert, PhD
Executive Chairman
650-218-1840
mweickert@chelationpartners.com
2. DIBI – Denying Iron to Bacterial Infections
Host
directed
therapy
• Starves infectious
microorganisms for iron which
they need to get from host
• Augments natural iron
sequestration biology deployed
by host in response to infection
Novel
Polymer
Drug
• Purpose-designed, non-toxic,
iron binding polymer
• 21 published studies of
efficacy in animal disease
models including sepsis
• Broad activity spectrum and
immune to drug resistance
Clinical start
in 2021
• NIAID and BARDA support in
the works
• $7M investment bring product
to Phase 2 clinical studies in
sepsis patients where BARDA
support is likely
DIBI
mweickert@chelationpartners.com CHELATION PARTNERS 2
3. mweickert@chelationpartners.com CHELATION PARTNERS 3
Sepsis is the leading cause of death in hospitals
First World Problem
Sepsis
Worldwide Problem
270K
270,000 Americans die from sepsis every year;
more than from prostate cancer, breast
cancer, and opioid overdoses combined
1.7M
1,700,00 Americans get sepsis annually.
1 in 3 patients who die in a
hospital have sepsis.
4. 4
A unique infection and sepsis approach
by
focusing on host defense rather than attack the pathogen
Attack the
Pathogen
Antivirals
Antibiotics
Antifungals
Antiparasitics
Host defense
we move to…
Augmenting host iron
sequestration defense is effective
against any pathogen attack and
immune to resistance
For decades infectious
disease control =
mweickert@chelationpartners.com CHELATION PARTNERS
5. DIBI polymer designed for safety and antimicrobial use
• Combines GRAS* polymer PVP used
pharmaceutically since 1950s with an
innovative iron binding domain similar to
deferiprone (FDA approved in 2011)
• Non-toxic
• Sepsis model: DIBI and antibiotic prolongs survival
or cures otherwise fatal bacterial sepsis in mice
• Only 1 or 2 DIBI doses
• All surviving animals are free of any infection
mweickert@chelationpartners.com CHELATION PARTNERS 5
*GRAS = Generally Regarded as Safe by US FDA Source: Fokam et al., 2020a
0 12 24 36 48 60 72 84 96 108 120 132 144 156 168
0
50
100
Time (hours)
Survival
(%)
CASP-I
CASP-I+IMI+DIBI
CASP-I+IMI
SHAM-I
CASP-I+IMI+DIBI2
CASP-I+DIBI
Groups:
6. Well established science and patents
• 1 issued and 1 allowed US patent
• US patent #10,709,784 – also granted: Aus,
JPN, pending: EU, CAN
• 1 more patent pending
• 21 peer-reviewed scientific publications
• 4 more pending
• >10 collaborations with infectious disease
research labs
• In discussions with NIAID* and BARDA**
for program support
• Successful TechWatch meeting with BARDA in
Nov. 2020, applied to invited EZ-BAA
• Signed Non-Clinical Evaluation Agreement in
December 2020 with NIAID
mweickert@chelationpartners.com CHELATION PARTNERS 6
*National Institute of Allergy and Infectious Diseases and the **Biomedical Advanced Research and Development Authority
7. Sepsis is an enormous untapped market
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Sales
($US
Millions)
DIBI Sales Sepsis
6MM DIBI sepsis sales ($M)
US DIBI sepsis sales ($M)
mweickert@chelationpartners.com CHELATION PARTNERS 7
Market Model Assumptions
30% Market penetration: diagnosed sepsis patients
7 days treatment sepsis patients
$1,000 Price per day DIBI
Sepsis is just the beginning
• Patents cover API and use in bacterial,
fungal, parasitic and viral diseases, as
well as cancer, sepsis and other
conditions
• Lucrative and sustainable anti-infective
business
• Meets ideal product profile for many other
indications
• Multiple licensing opportunities
• Different drug forms, delivery, strengths,
indications
• Attractive company for acquisition
• Possible IPO candidate in 1-2 years
8. Capital required (USD)
• $9 million to complete:
• $2.1M – > 10 Kg scale GMP DIBI manufacturing scale up, drug product and analytical
• $1.2M – 2-species GLP tox and IND-enabling non-clinical testing
• $175k – Regulatory support (Pre-IND meeting and IND filing)
• $1.5M – Normal volunteer Phase 1 MTD study
• $4.0M – Corporate team, consultants and operations
• Allows Phase 2 study initiation after IND in ~16 months
• 1st $3M CAD investment leverages >2x capital through Canadian programs
• Unlocks existing ACOA grant of >$450k CAD and $3M CAD in matching investment
• Willing to close investment that unlocks these matches as first tranche of $9M.
• Will seek $25 million once IND clears FDA for clinical studies through Phase 2 POC in
sepsis/cytokine storm, antibiotic resistant infections, oral DIBI for cholera and C. difficile
infections and pulmonary DIBI for VAP (ventilator associated pneumonia) and Cystic
Fibrosis
8
mweickert@chelationpartners.com CHELATION PARTNERS
9. Chelation Partners team for DIBI development
Michael Weickert, PhD – Executive Chairman, CEO
28 + years of anti-infective and cancer drug development, CEO
Pacylex, Sonescence, SEA Medical., COO Greenfire, Ohm Oncology,
Therashock, VP/Dir Ligand, Nektar, Auspex, SciDose, Somatogen,
NIH / NCI, PhD Genetics
9
mweickert@chelationpartners.com CHELATION PARTNERS
Bruce Holbein, PhD – CSO, Founder, Director
30 + years of both academic and industrial experience. Pioneered
research on role of iron in bacterial pathogenesis. Inventor of DIBI
and on over 20 biotechnology patents. PhD Microbiology
Robert Miller – CFO
CFO Nivagen, Sonoma Pharmaceuticals, GAF Corporation, Penwest
Co., Ameron Corp., and Bugle Boy. Treasurer of Mead Corporation,
VP of investment banking at Blyth, Eastman Dillon & Co. Analyst at
Merrill Lynch. BA in Economics, MBA
Andrew Heaton, PhD – COO
20+ years experience in Biotech driving NCEs and novel delivery
technologies from pre-IND through Phase III. CSO Cure JM
Foundation, former CEO Novogen N. Am., board member at
Novogen Ltd (Australia), PhD Chemistry, MBA.
James Drage – Director
Partner, Atlantic Venture Capital, Interim CEO, Algaculture International.
James is an entrepreneur and Venture Capitalist based in Halifax. His
daughter who almost died when she developed severe septic shock due
to an antibiotic resistant infection so he found Chelation and invested.
Anne-Marie Druliege, MD – Director, Co-Chair, SAB
25+ years senior executive experience in anti-infective and cancer drug
development, CMO PANCAN, CIRM Board member, former CMO Rigel
Pharma, EVP ChemoCentryx, CMO Affymax, Chiron (including sepsis Phase
3 program), Genentech. MD Paris Medical, MS Epidemiology, Harvard.
Management Board members
Scientific Advisory Board members
Karen Smith, MD, PhD, MBA, LLM
Proven CEO/CMO leader with pharma and biotech depth, Director
Acceleron, Sangamo, Antares, prior Director Forward, Sucampo, Eliminate
Cancer (CEO), Susan G. Komen, CMO Emergent, former Jazz, Allergan, AZ,
BMS
Khama Ennis, MD, MPH, FACEP
Emergency Physician, Associate Chief of Emergency Medicine and
Medical Staff President at Cooley Dickinson Hospital. MD NYU School
of Medicine, MPH Harvard, Residency at Massachusetts General and
Brigham & Women’s Hospitals
Belinda Tsao Nivaggioli, Ph.D. – Director
Founded CN Partners, PE fund, in healthcare and high-tech. CEO of
QuRetino, Peninsula Skincare labs, Avicena Group, also at Gillette and
Oral-B. Ph.D. U. Toronto, postdoc MIT.
Christian Lehmann, MD PhD FRCPC
Professor Dalhousie University, Staff Anesthesiologist, Nova Scotia Health
Authority. >25 years of experience in experimental and clinical
inflammation research. Author of more than 150 original publications,
member Cystic Fibrosis Translational Research (CFTR) group.
10. DIBI: A New Hope for Antimicrobial Resistant Infections and Sepsis
• Ideal for an early therapeutic intervention in suspected or confirmed infections
• Extremely safe and non-toxic
• Kills or slows infection including by drug resistant pathogens
• Downregulates cytokines to slow or stop septic shock / cytokine storm
• Can be combined synergistically with pathogen specific agents to clear the infection
• Invulnerable to the development of resistance
Status:
• Supported by 21 published peer-reviewed proof-of-concept studies
• Non-GLP rat tox complete, non-toxic – ready for GLP tox, IND and clinical development
• GMP manufacturing at 100gms scale – ready for 1kg scale-up
• US patent #10,709,784 also granted in Aus, JPN, pending: EU, CAN, 2nd patent allowed
• $9M to get to Phase 2 Sepsis clinical study which may then be supported by BARDA
mweickert@chelationpartners.com CHELATION PARTNERS 10
Buys time in sepsis
Reduces mortality