Investment Profile
Investment Profile
Curative cell therapy mending broken hearts
2020 Series-A
$10m Investment
Opportunity
$40m Series-B follow-on
investment 2022
Curative cell therapy mending broken hearts
2020 Series-A
$10m Investment Opportunity
$20m follow-on investment 2022
For further details click here to register your interest
For further details click here to register your interest
INTRODUCTION & UNMET NEEDS
INTRODUCTION & UNMET NEEDS
Heart Failure (Myocardial Infarction) has no cure. It is a $108bn global healthcare market necessitated by long-term post-MI health management at high payer cost. Current therapies do not address core need, i.e. fundamentally recover heart function.
PluriCell Biotech
Novel Proprietary Regenerative Heart Cell Therapy
• Limitless Induced Pluripotent Stem Cells (iPSC) Replication
• Precise Heart Cell Differentiation + Automated Production
• Minimally Invasive Therapeutic Application
BETTER FUNDAMENTAL SOLUTION MUCH CHEAPER
INVESTMENT OPPORTUNITY:
PluriCell invites a $10m Series-A equity investment in 2020 to advance to large animal clinical trials, leading to a Series-B follow-on investment in 2022.
INTRODUCTION & UNMET NEEDS
INTRODUCTION & UNMET NEEDS
Heart Failure (Myocardial Infarction) has no cure. It is a $108bn global healthcare market necessitated by long-term post-MI health management at high payer cost. Current therapies do not address core need, i.e. fundamentally recover heart function.
PluriCell Biotech
Novel Proprietary Regenerative Heart Cell Therapy
• Limitless Induced Pluripotent Stem Cells (iPSC) Replication
• Precise Heart Cell Differentiation + Automated Production
• Minimally Invasive Therapeutic Application
BETTER FUNDAMENTAL SOLUTION MUCH CHEAPER
INVESTMENT OPPORTUNITY:
PluriCell invites a $10m Series-A equity investment in 2020 to advance to large animal clinical trials, leading to a Series-B follow-on investment in 2022.
MARKET OPPORTUNITY
CARDIOVASCULAR DISEASES (CVD)
Cardiovascular diseases cause 1/3 of deaths globally; Chronic Ischemic Heart Failure (HF) being one of them. At present, there is no approved therapy that addresses the core Heart Failure issue – loss of ‘contractile’ heart cells
HF affects 26m people worldwide, 5.7m in U.S. impacting 20% of over-40 adults with 50% mortality at 5 years. All available HF therapies are ultimately palliative, yet cost global healthcare systems $108bn p.a.
US HF costs are $44bn pa, projected to rise to $70bn in 2030, with half those costs related to hospitalisation
OPPORTUNITY: PluriCell to exploit market with its
automated process generating a near-limitless supply of
iPSC-based differentiated Heart Cells and therapeutic
application via minimally invasive procedures at 1% COGs.
MARKET OPPORTUNITY
CARDIOVASCULAR DISEASES (CVD)
Cardiovascular diseases cause 1/3 of deaths globally; Chronic Ischemic Heart Failure (HF) being one of them. At present, there is no approved therapy that addresses the core Heart Failure issue – loss of ‘contractile’ heart cells
HF affects 26m people worldwide, 5.7m in U.S. impacting 20% of over-40 adults with 50% mortality at 5 years. All available HF therapies are ultimately palliative, yet cost global healthcare systems $108bn p.a.
US HF costs are $44bn pa, projected to rise to $70bn in 2030, with half those costs related to hospitalisation
OPPORTUNITY: PluriCell to exploit market with its
automated process generating a near-limitless supply of
iPSC-based differentiated Heart Cells and therapeutic
application via minimally invasive procedures at 1% COGs.
SOLUTION
PLURICELL CELL THERAPY
• Reprogrammed allogenic adult donor cells, i.e. blood
• Gene edit to be hypoimmunogenic
• Cell Bank creation, both Master and Working:
- MCB – step performed just once
- WCB – step performed as needed according to patient dosage required
• iPSC proliferation derived derived from bioreactor MCB stock, using suspension to obtain required batch
• iPSC differentiation into cardiomyocytes, and cryopreservation for future use
• Minimally invasive therapeutic delivery procedures
PLATFORM TECHNOLOGY & KNOWHOW
PluriCell’s proposition is platform-based so
could also be applied to different cell therapies,
e.g. neurological applications
SOLUTION
PLURICELL CELL THERAPY
• Reprogrammed allogenic adult donor cells, i.e. blood
• Gene edit to be hypoimmunogenic
• Cell Bank creation, both Master and Working:
- MCB – step performed just once
- WCB – step performed as needed according to patient dosage required
• iPSC proliferation derived derived from bioreactor MCB stock, using suspension to obtain required batch
• iPSC differentiation into cardiomyocytes, and cryopreservation for future use
• Minimally invasive therapeutic delivery procedures
PLATFORM TECHNOLOGY & KNOWHOW
PluriCell’s proposition is platform-based so
could also be applied to different cell therapies,
e.g. neurological applications
COMPETITIVE LANDSCAPE & USPs
KEY DIFFERENTIATORS
Cell Therapy market evermore validated by big pharma, especially the Japanese, who are increasing their iPSC-based regenerative investments.
SME-level competitors largely relying on the potential paracrine effect – currently yielding mixed peer-reviews
A small number of emerging competitors currently trialling IPSC-based HF cell therapy approaches but their models may not sustainably achieve PluriCell’s low cost base
Several companies are taking the autologous pathway, not the allogenic one, raising logistic, scalability and cost issues
In the foreseeable future, comparable competitors are unlikely to achieve PluriCell’s cost reduction capability
PLURICELL: A BETTER CHEAPER SOLUTION FOR MASS MARKET
KEY DIFFERENTIATORS: Pluricell’s USPs are its exceptional iPSC production scalability, its automated cardiomyocyte differentiation, its minimally invasive therapeutic protocol
COMPETITIVE LANDSCAPE & USPs
KEY DIFFERENTIATORS
Cell Therapy market evermore validated by big pharma, especially the Japanese, who are increasing their iPSC-based regenerative investments.
SME-level competitors largely relying on the potential paracrine effect – currently yielding mixed peer-reviews
A small number of emerging competitors currently trialling IPSC-based HF cell therapy approaches but their models may not sustainably achieve PluriCell’s low cost base
Several companies are taking the autologous pathway, not the allogenic one, raising logistic, scalability and cost issues
In the foreseeable future, comparable competitors are unlikely to achieve PluriCell’s cost reduction capability
PLURICELL: A BETTER CHEAPER SOLUTION FOR MASS MARKET
KEY DIFFERENTIATORS: Pluricell’s USPs are its exceptional iPSC production scalability, its automated cardiomyocyte cell differentiation, its minimally invasive therapeutic protocol
MISSION
PluriCell is to disrupt this market with its automated processes, generating a near-limitless supply of iPSC-based differentiated Heart Cells at just 1% of current COGs and coupled to its minimally invasive application, overall therapy cost will reduce current long term healthcare management costs by more than half
HEALTHCARE ECONOMICS
QUALITY ADJUSTED LIFE YEARS (QALY) MEASURE
HF patients require up to 10 billion heart cells to receive an effective HF therapy
Non-optimized protocols yield prohibitive therapy costs/patient
ICER Report (Institute for Clinical and Economical Review) cited the range of acceptable therapy cost, inter alia, at $50k-$150k based on QALYs
COST OF ILLNESS (COI) MEASURE
After diagnosis, patients currently cost up to $150k for their last 2 years of remaining life. PluriCell’s curative iPSC-based HF therapy forecast to cost from $60k-$70k / patient, halving current therapy costs
ECONOMIC ARGUMENT:
PluriCell’s curative iPSC-based HF therapy forecast to
cost from US$60k-US$70k/ patient
HALVING CURRENT THERAPY COSTS
HEALTHCARE ECONOMICS
QUALITY ADJUSTED LIFE YEARS (QALY) MEASURE
HF patients require up to 10 billion heart cells to receive an effective HF therapy
Non-optimized protocols yield prohibitive therapy costs/patient
ICER Report (Institute for Clinical and Economical Review) cited the range of acceptable therapy cost, inter alia, at $50k-$150k based on QALYs
COST OF ILLNESS (COI) MEASURE
After diagnosis, patients currently cost up to $150k for their last 2 years of remaining life. PluriCell’s curative iPSC-based HF therapy forecast to cost from $60k-$70k / patient, halving current therapy costs
ECONOMIC ARGUMENT:
PluriCell’s curative iPSC-based HF therapy forecast to
cost from US$60k-US$70k/ patient
HALVING CURRENT THERAPY COSTS
TRACTION & ROADMAP
TRACTION TO DATE
✓ Seed round $1.1m from a Brazilian Pharmaceutical company
✓ Successful Proof of Concept studies in rats
✓ Successful preliminary studies in Pigs
✓ Selected by US State Dept to participate in GIST
✓ Purdue Foundry Accelerator
BUSINESS INVESTMENT MODEL
✓ Treat Patients
✓ Demonstrate Improved Patient Outcomes
✓ Demonstrate Better Healthcare Economics
✓ Drive Physician Adoption
✓ Secure Insurance Company Reimbursement
ROADMAP
2020 – Series-A Investment
2021 – Scale-Up Heart Cell Production to 1bn Cells/Batch
2022 – Secure Series-B Investment, Commence Large Animal Trials
2023 – Conduct Studies For Minimally Invasive Delivery Device
2024 – Automate Heart Cell Production
2025 – Secure Investigational New Drug Approval
TRACTION & ROADMAP: Solid progress to date, third party
seed funding, major institution validation, competent
management team, clear pathway forward, evermore
compelling proposition
TRACTION & ROADMAP
TRACTION TO DATE
✓ Seed round $1.1m from a Brazilian Pharmaceutical company
✓ Successful Proof of Concept studies in rats
✓ Successful preliminary studies in Pigs
✓ Selected by US State Dept to participate in GIST
✓ Purdue Foundry Accelerator
BUSINESS INVESTMENT MODEL
✓ Treat Patients
✓ Demonstrate Improved Patient Outcomes
✓ Demonstrate Better Healthcare Economics
✓ Drive Physician Adoption
✓ Secure Insurance Company Reimbursement
ROADMAP
2020 – Series-A Investment
2021 – Scale-Up Heart Cell Production to 1bn Cells/Batch
2022 – Secure Series-B Investment, Commence Large Animal Trials
2023 – Conduct Studies For Minimally Invasive Delivery Device
2024 – Automate Heart Cell Production
2025 – Secure Investigational New Drug Approval
TRACTION & ROADMAP: Solid progress to date, third party
seed funding, major institution validation, competent
management team, clear pathway forward, evermore
compelling proposition
PLURICELL BIOTECH’S TECHNOLOGY DESCRIPTION
Using a world-first, proprietary, simple and robust production system, PluriCell is capable of producing cells at just 1% of the cost of current methods, enabling highly cost-effective production of bona fide human heart cells ex-vivo for therapeutic applications.
This technology, coupled to the use of gene-edited cell lines (for allogeneic off-the-shelf use of these cellular products) has the potential to reduce long-term heart failure patient healthcare costs by half, whilst increasing quality of remaining life.
PluriCell’s approach is to deliver billions of lab-made heart cells to patients’ hearts in a minimally invasive way, tackling the root challenge of heart failure today by restoring heart function. PluriCell is uniquely placed to achieve this with its novel high-scale heart cell production technology ex-vivo.
Pre-clinical trial results have already shown that using PluriCell’s heart cells, ‘twice as many’ cells have been successfully engrafted than cited elsewhere in relevant landmark publications, resulting in ‘improved heart function’ being clearly demonstrated in small animal trials.
Taken together, PluriCell’s proposition can potentially deliver restorative heart cell therapy to NYHA Class II/III heart failure patients for less than half of today’s lifetime healthcare management cost. Of all competitive approaches in development, PluriCell’s methodology is likely to be the only economically viable and sustainable solution to treat hundreds of thousands of patients per year. Furthermore, as a platform biotechnology, PluriCell intends, in time, to address other indications, e.g. neurological regeneration.
As manufacturing is key to the commercialisation of advanced cell and gene therapies, PluriCell has secured essential Intellectual Property via rights options, including an ‘exclusive, worldwide, whole of patent life’ license to enable high scale cardiomyocyte production from iPSCs at a 100x cost reduction. PluriCell will also use in-licencing for full therapeutic iPSC use, cardiomyocyte differentiation and hypoimmunogenic cell lines use, amongst others, enabling PluriCell a full IP freedom-to-operate.
This investment round will enable the development of a scaled-up manufacturing processes and a large-scale pre-clinical efficacy study that will deliver a value inflection point in the next raise in 2023.
PLURICELL BIOTECH’S TECHNOLOGY DESCRIPTION
Using a world-first, proprietary, simple and robust production system, PluriCell is capable of producing cells at just 1% of the cost of current methods, enabling highly cost-effective production of bona fide human heart cells ex-vivo for therapeutic applications.
This technology, coupled to the use of gene-edited cell lines (for allogeneic off-the-shelf use of these cellular products) has the potential to reduce long-term heart failure patient healthcare costs by half, whilst increasing quality of remaining life.
PluriCell’s approach is to deliver billions of lab-made heart cells to patients’ hearts in a minimally invasive way, tackling the root challenge of heart failure today by restoring heart function. PluriCell is uniquely placed to achieve this with its novel high-scale heart cell production technology ex-vivo.
Pre-clinical trial results have already shown that using PluriCell’s heart cells, ‘twice as many’ cells have been successfully engrafted than cited elsewhere in relevant landmark publications, resulting in ‘improved heart function’ being clearly demonstrated in small animal trials.
Taken together, PluriCell’s proposition can potentially deliver restorative heart cell therapy to NYHA Class II/III heart failure patients for less than half of today’s lifetime healthcare management cost. Of all competitive approaches in development, PluriCell’s methodology is likely to be the only economically viable and sustainable solution to treat hundreds of thousands of patients per year. Furthermore, as a platform biotechnology, PluriCell intends, in time, to address other indications, e.g. neurological regeneration.
As manufacturing is key to the commercialisation of advanced cell and gene therapies, PluriCell has secured essential Intellectual Property via rights options, including an ‘exclusive, worldwide, whole of patent life’ license to enable high scale cardiomyocyte production from iPSCs at a 100x cost reduction. PluriCell will also use in-licencing for full therapeutic iPSC use, cardiomyocyte differentiation and hypoimmunogenic cell lines use, amongst others, enabling PluriCell a full IP freedom-to-operate.
This investment round will enable the development of a scaled-up manufacturing processes and a large-scale pre-clinical efficacy study that will deliver a value inflection point in the next raise in 2023.
Key Contacts
Key Contacts
David D’Alton
Chairman
Oyster Venture Partners
M: +44 (0)7836 224422
E: david.dalton@oystervp.com
oysterventurepartners.com
Dr Marcos Valadares
CEO & Co-Founder
PluriCell Biotech
M: +55 11 99326-0056
E: marcos.valadares@pluricell
biotech.com.br
Click here to email David
Click here to email Marcos
Within the meaning of the Financial Services and Markets Act 2000, the content herein has not been approved by an authorised person. Reliance on this communication for the purpose of engaging in any investment activity may expose an individual to a significant risk of losing all investment.
David D’Alton
Chairman
Oyster Venture Partners
M: (0)7836 224422
E: david.dalton@oystervp.com
oysterventurepartners.com
Click here to email David
Dr Marcos Valadares
CEO & Co-Founder
PluriCell Biotech
M: +55 11 99326-0056
E: marcos.valadares@pluricellbiotech.com.br
Click here to email Marcos
The content of this communication has not been approved by an authorised person within the meaning of the Financial Services and Markets Act 2000. Reliance on this communication for the purpose of engaging in any investment activity may expose an individual to a significant risk of losing all investment.
To register your interest, please complete the form below and click submit or contact David D’Alton as per the email address above.