Hemoglobin Oxygen Therapeutics LLC

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Disclaimer

 
This document was prepared by Hemoglobin Oxygen Therapeutics LLC (“HbO2 Therapeutics” or

Disclaimer This document was prepared by Hemoglobin Oxygen Therapeutics LLC (“HbO2 Therapeutics”
the “Company”) to be used exclusively during presentations with qualified investors or qualified professionals.
This document has been provided to you for information purposes only. It does not constitute an offer or invitation to sell or issue, or any solicitation of an offer to purchase or subscribe for, any shares of the Company and neither it nor any part of it shall form the basis of, or be relied upon in connection with, any contract or commitment whatsoever. It is confidential and must be considered as such by those attending the presentation. It must not be reproduced, redistributed or published, in whole or in part, under any circumstances, nor can it be distributed to persons other than those invited to these presentations. The Company, its boards or its representatives shall under no circumstances be liable for any loss or damage resulting from the use of this presentation or the information it contains.
This information herein is only provided as of the date of this document and may be updated, augmented, revised, verified or amended. It could be significantly amended. The Company is under no obligation to update the information contained in this document and any views expressed herein could be amended without prior notice.
This document contains information about the Company’s markets and competitive position therein. To the Company’s knowledge, there are no authoritative external reports providing exhaustive and comprehensive coverage or analysis of the Company’s markets. Consequently, the Company has made estimates based on a number of sources including internal surveys, studies and statistics from independent third parties, specialist publications, figures published by the Company’s competitors and data from operational subsidiaries. This information has not been independently verified and does not constitute official data.
Some of the information contained in this document includes forward-looking statements that reflect the parties’ current expectations and views of future events. These forward-looking statements are subject to a number of risks and uncertainties, as they relate to events and depends on circumstances that may or may not occur in the future, many of which are beyond our control, which could cause actual results to differ materially from such statements. These forward-looking statements are based on our beliefs, assumptions and expectations of future performance, taking into account the information currently available to us. These forward-looking statements relate to the Company’s future outlook, development and commercial strategy and are based on analyses of forecasts of future results and estimates of amounts not yet determinable.. HbO2 Therapeutics draws your attention to the fact that the forward-looking statements may not, under any circumstances constitute a guarantee of future performance and that its real financial position, results and cash flow, as well as the changes in the sector in which HbO2 Therapeutics operates, may differ significantly from those proposed or suggested by the forward-looking statements contained in this document, and there can be no assurance that the actual results or developments anticipated by us will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, us or our business or operations.
If an offer of securities is made by the Company in the future, prospective investors should rely solely on (i) the Prospectus or offering memorandum to be prepared by the Company for the purposes of such offering, including in particular the risk factors described therein, (ii) any notices that are published by the Company and that expressly amend the terms of the offering, and (iii) any examinations of the Company that any prospective investor may deem necessary. No reliance may be placed for any purposes whatsoever on the information contained in this presentation, or on its completeness, accuracy or fairness. It is the responsibility of each prospective investor, if an offer of securities is made in the future, to review the Prospectus carefully and to make an independent assessment of the risks and merits of the offering.

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Mission Statement

To develop and commercialize the first and best in class technology

Mission Statement To develop and commercialize the first and best in class
platform for oxygen-carrying solutions addressing critical unmet medical needs in human and veterinary indications.

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Company at a Glance

Delaware registered in 2014, technology is going back to

Company at a Glance Delaware registered in 2014, technology is going back
1990s with $1 billion invested
$20 million in equity financing to date
Acquired and developed the intellectual property for two Hemoglobin-Based Oxygen Carrier (HBOC) products :
Hemopure (HBOC-201) for human use
Oxyglobin (HBOC-301) for veterinary use
Existing collaborations in veterinary and human markets
Groundbreaking HBOC organ perfusion technology
Currently 12 employees
Production facility in Souderton, Pennsylvania

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Brian Dawson
Senior Director, Process Development

25 years experience in development & commercialization of

Brian Dawson Senior Director, Process Development 25 years experience in development &
HbO2’s products from pre-clinical research to product approval & marketing.

Igor Serov
Co-Founder & CFO

Over 20 years of investment banking experience

Greg Dube, PhD
VP, Research & Development

30 years experience in drug R&D in large pharma and biotech firms.

Arkadiy Pitman
Senior Director, Statistics & Data Management

20 years of pharmaceutical & healthcare US experience with strong background in mathematics, statistics & logistics.

Melissa Zafirelis
Director, Regulatory & Clinical Operations

Over 22 years multinational regulatory & clinical operations experience.

Joseph Rappold, MD
Chief Medical Officer

30 years of active service (US Navy) with 6 combat deployments commanding a variety of medical facilities. Professor of Surgery at Tufts University. Chief of Acute Care Surgery and Trauma Medical Director at Maine Medical Center.

Highly experienced team

Fantao Meng
Director of Research and Development

Hemoglobin specialist with 20 years of research experience in developing hemoglobin-based oxygen carriers (HBOCs)

Zaf Zafirelis
Co-Founder & CEO

30 years of Biotech, Pharma, and Medical Device industries
More than 20 years CEO experience
Raised more than $100 million with successful exits

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Hemopure and Oxyglobin HBOCs with unique efficacy and safety profiles…

Hemopure and Oxyglobin HBOCs with unique efficacy and safety profiles…

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Worldwide blood shortage

COVID-19 pandemic highlights the need for a product that can

Worldwide blood shortage COVID-19 pandemic highlights the need for a product that
successfully substitute blood’s oxygen carrying capacity in time of need

Shortages of blood donations, not reaching the critical threshold of 30 per 1000 population in many countries

Russia and South Africa alone cumulate a 3 millions blood units shortfall.
Blood shortage represents a $1 billion worldwide market per year.

Global Status Report on Blood Safety and Availability 2016

Hemopure has received marketing authorizations for acute anemia in South Africa & Russia

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Strategic National Stockpiles
Out-of-hospital / Ambulance services
Remote locations / Military battlefield use

Prehospital trauma

Strategic National Stockpiles Out-of-hospital / Ambulance services Remote locations / Military battlefield
(military & civilian) and disaster preparedness in the US markets represent $500 million in revenue per year.

Prehospital Trauma & Medical Readiness

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Blood Is Not An Option

Blood disorders including Sickle Cell disease, Hemolytic Anemia,

Blood Is Not An Option Blood disorders including Sickle Cell disease, Hemolytic
etc.
Rare blood types
Religious objectors (refuse blood transfusion).

BNO

160,000 patients with blood disorders need transfusions per year in US and Europe, which represents $400 million in revenue per year. Religious objectors represent another $149 million in annual revenue in the United States alone.

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Blood shortage, a similar issue in veterinary markets

2 million canine transfusions are

Blood shortage, a similar issue in veterinary markets 2 million canine transfusions
needed annually in US and in Europe
Veterinary product is approved in US and EU
30 different species has been successfully treated with Oxyglobin

The US and European canine markets represent $550 million in revenue.

Only up to 25% of veterinary transfusion blood supplies are covered by blood banks
84% of US veterinarians are dissatisfied with current options

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ZK1

Nutrients

There is a constant demand for donated organs
Organ eligibility criteria are extremely

ZK1 Nutrients There is a constant demand for donated organs Organ eligibility
severe
The ability to extend the life of organs ex-vivo and to assess their compatibility and health can dramatically improve the supply for transplantations
The perfusion process allows doctors to assess reconditioning and viability of organs, limbs and tissues prior to transplantation both at room temperature and body temperature (37oC)

The transplantation market amounts to $137 million per year.

Organ Transplantation: Another Worldwide Shortage

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Additional indications include…

Ischemia indications including
Minimization of infarct size (STEMI - ST-Elevation myocardial

Additional indications include… Ischemia indications including Minimization of infarct size (STEMI -
infarction)
Resuscitation from sudden cardiac arrest
Minimization of tissue loss in Limb ischemia / PAD claudication
Antidote for carbon-monoxide and cyanide poisoning
Oncology with solid tumors
Burn victims and plastic surgery
Perfusion of
Limbs prior to transplantation
Brain cells for diagnostic purposes

The average potential US market size in each of these new indications is $500m.

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Robust Pipeline

Robust Pipeline

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Strong value creating recent progress

US Department of Defense signed and sponsored Hemopure

Strong value creating recent progress US Department of Defense signed and sponsored
trial for pre-hospital trauma
Groningen liver transplantation trial finalized with 100% success
Patent filed for HBOC/Freeze Dried Plasma combination
Collaboration signed with Department of Defense and Teleflex on Hemopure use as a reconstitution agent for FDP
Yale University brain perfusion study with Hemopure published in Nature
Publication of high dose Hemopure case series
Patent filed for smoke inhalation antidote
Publication of an article supporting use of Hemopure in emergency preparedness including pandemics such as COVID-19

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Strong value creating milestones

FDA submission for Hemopure Phase 3 pivotal BNO clinical

Strong value creating milestones FDA submission for Hemopure Phase 3 pivotal BNO
trial
Start of hand transplant study
Submission of the IDE for the kidney perfusion trial
Oncology collaboration for the treatment of refractory solid tumors
Completion of production facility
Filing of CE Mark for perfusion solution
cGMP facility validation by US & EU regulators
Oxyglobin market launch
Hemopure market launch in South Africa

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Major academic & health centers collaborations

Major academic & health centers collaborations

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Expanded access program hospitals

Expanded access program hospitals

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Over 300 peer-reviewed publications

Over 300 peer-reviewed publications

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Characteristics of Hemopure

Hb concentration 13 g/dL
Plasma half-life ~ 19 hours
Size = ~

Characteristics of Hemopure Hb concentration 13 g/dL Plasma half-life ~ 19 hours
1 million < RBC
Stable for 3 years at 2-30 °C
Iso-osmotic, iso-oncotic
P50 = 40 mm Hg
Colloid (COP ~ to 6% albumin)
Viscosity = 2.1 cP (~4 cP for RBC)

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Relative Efficacy to Increase Total Hb

Impact of 250 mL : PRBCs >

Relative Efficacy to Increase Total Hb Impact of 250 mL : PRBCs
whole blood, > Hemopure, > hetastarch

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Vital Organ Blood Flow

MAP responds to Hemopure; ↑ 10 – 20 mmHg

Vital Organ Blood Flow MAP responds to Hemopure; ↑ 10 – 20

Vital organ blood flow maintained

Mongan et al, J. Trauma 67:51-60, 2009

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Tissue Oxygenation
Vital Organ Oxygenation Maintained

Hemodilution carried out in 3 stages: 10%, 30%,

Tissue Oxygenation Vital Organ Oxygenation Maintained Hemodilution carried out in 3 stages:
50%
Organ-specific tissue PO2 determination via EPR imaging

Model

Results

Muir et al Shock v35, 597-603, 2011

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Expanded Access Real World Clinical Experience
Representative Cases

Three sickle cell patients in crisis:

Expanded Access Real World Clinical Experience Representative Cases Three sickle cell patients
RBCs refused/unavailable
Hb nadirs 3.5 - 4.0 g/dL
Febrile, MOF, neurologic dysfunction.
Hemopure administered: 6, 23, and 27 Units
Full recoveries
Kidney – Pancreas transplant: RBCs refused
Hb Nadir 2.0 g/dL
Tachycardia, tachypnea.
Hemopure administered: 12 units.
Full recovery
Autoimmune Hemolytic Anemia: RBCs refused
Hb nadir 4.6 g/dL
Elevated lactate
Hemopure administered: 27 units.
Full recovery

Davis et al, Transfusion, v58, 132-137, 2017

Gomez et al, Am J Transplant, v17, 1941-1944, 2017

Epperla et al, Transfusion, v56, 1801-1806, 2016

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Ex-situ Perfusion prior to Transplantation

Transplantation of high-risk donor livers after ex situ

Ex-situ Perfusion prior to Transplantation Transplantation of high-risk donor livers after ex
resuscitation and assessment using combined hypo- and normothermic machine perfusion: a prospective clinical trial

DHOPE = dual hypothermic oxygenated machine perfusion (4°C - 12°C).
COR = controlled oxygenated rewarming.
NMP = normothermic machine perfusion (37°C)

Declined livers (ECD = high-risk)

Post-operative results
12-mo Graft survival: 100% (≥ std DCD & DBD)
Peak ALT & AST: << std DBD & DCD
DHOP-COR-NMP: ↑ donor livers 20% vs. std DCD & DBD

Van Leeuwen et al, Ann Surg, 2019

de Vries Y, et al. BMJ Open 2019

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Manufacturing capacities

Facility building is fully constructed
Stage I is in place and

Manufacturing capacities Facility building is fully constructed Stage I is in place
operational ($20m replacement value)
Stage II – all equipment is acquired and waiting for installation ($70m replacement value)
Production facility fully operational in 9 months
Expansion capacity is secured on an adjacent plot

The manufacturing process involves two stages:

Certification from US and EU regulators is expected in 18 months

Stage I

Stage II

Hemopure

Oxyglobin

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Cash positive in 2023 with $50m investment $20m commitment secured

Cash positive in 2023 with $50m investment $20m commitment secured
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