Product Pipeline

CannEpil®

Refractory
Epilepsy
Phase II

Early Stage Revenue generating refractory epilepsy seizure control treatment

Approximately 30% of generalised seizure epilepsy patients have Refractory Epilepsy aka “Drug-Resistant Epilepsy” (DRE)1, representing 15,000,000 patients around the world.
CannEpil® is now available to patients in the UK by Named Patient Request, to be prescribed by clinicians listed on the GMC Specialist Register. ​ ​
The first UK patient has access to CannEpil® through the NHS RESCAS pathway and the “I am Billy Foundation”, they have been using CannEpil® for over 1.5 years. ​
CannEpil® is accepted by the Irish Health Product Regulatory Authority (HPRA), and full health insurance coverage is obtained through the Medicinal Cannabis access program (MCAP)​.
1) Fattorusso A, et al. (2021) The Pharmacoresistant Epilepsy: An Overview on Existent and New Emerging Therapies. Front. Neurol. 12:674483.
2) https://www.biospace.com/article/epilepsy-therapeutics-market-worth-15-1-bn-by-2030-at-a-cagr-of-4-5-percent-/
Data on file – CannEpil Driving Performance
Data on file – CannEpil vs. MXP100 study

Market Potential

Worldwide Potential
Patients with DRE
15M
UK Potential
Patients with DRE
150K
CannEpil Treatment Estimate
per patient per annum
£70004

Forwards looking:

Commercial strategy is a combination of 3rd party distribution supported by in-house Medical Scientific Liaison
Key wholesaler partners in the UK and Europe: PCCA and Medisonal clinic
Continuing the work with the ‘I am Billy’ Foundation and the pathway to NHS RESCAS for Paediatric Refractory Epilepsy
Dedicated in-house Neurology and Paediatrician collaboration with the European Paediatric Neurology Society5
4) Alacrita Report 2019
5) http://dpnsee.org/2019/01/22/treatment-with-medicines-derived-from-cannabis/

Key Points

CannEpil® already sold in the UK, Ireland and Australia
There are 506 million epilepsy sufferers of which 6.21 million in Europe and the UK
Approximately 30% of generalized seizure epilepsy patients have Refractory Epilepsy aka “Drug-Resistant Epilepsy” (DRE)7

6) https://www.who.int/news-room/fact-sheets/detail/epilepsy  Fattorusso A, et al. (2021) The Pharmacoresistant Epilepsy
7) Overview on Existant and New Emerging Therapies. Front. Neurol. 12:674483.

CimetrA®

Acute Lung Injury
and ARDS
Phase III

Early Stage Revenue Generating Immunomodulation Treatment for ARDS

CimetrA® — representing over US$ 2,500,000 in sales to date.
CimetrA® delivered 50,000 units to the USA market (Under Special Access) and over 100,000 worldwide.
Results of Preclinical and Clinical program, meeting FDA guidelines, to date:
  • Demonstrated suppression of cytokine storm in Phase II Clinical Trials1
  • Demonstrated significant reduction in C-reactive protein (CRP), a major inflammatory marker2.
  • The biological markers in the blood tests further proved a reduction of inflammation, enterohepatic involvement, and liver reactant proteins1
  • Effective blocking of the IL-32mRNA expression1, the pro-inflammatory cytokine related to Autoimmune diseases,  lupus, rheumatoid arthritis, inflammatory bowel disease, asthma, and chronic obstructive pulmonary disease1
  • Preclinical studies in rodents (rats, mice) and non-rodent (swine) confirm the safety profile, with no formulation-related toxicity detected3
1) Data on file – CimetrA in-vitro study
2) Data on file – Interim results – CimetrA Dose Finding Study
3) Data on file – CimetrA pre-clinical study

Market Potential

Cases of severe illness of influenza worldwide1
3–5M
per
annum
Respiratory
deaths
150K
per
annum
Potentially, CimetrA® can be used to treat inflammatory conditions with £100B2 total addressable market

Key Points

Sales strategy is to licence and distributes through 3rd party distribution supported by in house Medical Scientific Liaison
Sales strategy is to licence and distributes through 3rd party distribution supported by in house Medical Scientific Liaison
Key wholesaler partners in the USA and MENA — AMC
Initiate CimetrA® IND submission to the US FDA

Strategic Milestones

CimetrA® IND submission to the US FDA
1) https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal)
2) https://www.precedenceresearch.com/anti-inflammatory-therapeutics-market

CogniCann®

Dementia
and Alzheimer’s
Phase II

Dementia and Alzheimer’s ​

55 million people worldwide suffering from Dementia and Alzheimer’s1
Patients in the Placebo group experienced a deterioration in their condition, compared with the stable neuropsychiatric profile of those patients in the treatment group with CogniCann®2
CogniCann® designed as a treatment for the symptoms associated with Dementia and Alzheimer’s
This important finding indicates not only improvement in the health status of the patients and also the improved quality of life of the families and caregivers taking care of dementia patients​
1) https://www.who.int/news-room/fact-sheets/detail/dementia
2) Data on file : CogniCann Phase II study, Australia

CannEpil®

Refractory
Epilepsy
Phase II

Early Stage Revenue generating refractory epilepsy seizure control treatment

Approximately 30% of generalised seizure epilepsy patients have Refractory Epilepsy aka “Drug-Resistant Epilepsy” (DRE)1, representing 15,000,000 patients around the world.
CannEpil® is now available to patients in the UK by Named Patient Request, to be prescribed by clinicians listed on the GMC Specialist Register. ​ ​
CannEpil® is accepted by the Irish Health Product Regulatory Authority (HPRA), and full health insurance coverage is obtained through the Medicinal Cannabis access program (MCAP)​.
The first UK patient has access to CannEpil® through the NHS RESCAS pathway and the “I am Billy Foundation”, they have been using CannEpil® for over 1.5 years. ​

1) Fattorusso A, et al. (2021) The Pharmacoresistant Epilepsy: An Overview on Existent and New Emerging Therapies. Front. Neurol.
12:674483.
2) https://www.biospace.com/article/epilepsy-therapeutics-market-worth-15-1-bn-by-2030-at-a-cagr-of-4-5-percent-/
Data on file – CannEpil Driving Performance
Data on file – CannEpil vs. MXP100 study

Market Potential

Worldwide Potential
Patients with DRE
15M
UK Potential
Patients with DRE
150K
CannEpil Treatment Estimate
per patient per annum
£70004

Forwards looking:

Commercial strategy is a combination of 3rd party distribution supported by in-house Medical Scientific Liaison
Key wholesaler partners in the UK and Europe: PCCA and Medisonal clinic
Continuing the work with the ‘I am Billy’ Foundation and the pathway to NHS RESCAS for Paediatric Refractory Epilepsy
Dedicated in-house Neurology and Paediatrician collaboration with the European Paediatric Neurology Society5
Initiate CannEpil®️ IND submission to the US FDA
4) Alacrita Report 2019
5) http://dpnsee.org/2019/01/22/treatment-with-medicines-derived-from-cannabis/

Key Points

CannEpil® already sold in the UK, Ireland and Australia
There are 506 million epilepsy sufferers of which 6.21 million in Europe and the UK
Approximately 30% of generalized seizure epilepsy patients have Refractory Epilepsy aka “Drug-Resistant Epilepsy” (DRE)7
6) https://www.who.int/news-room/fact-sheets/detail/epilepsy  Fattorusso A, et al. (2021) The Pharmacoresistant Epilepsy
7) Overview on Existant and New Emerging Therapies. Front. Neurol. 12:674483.

CimetrA®

Acute Lung Injury
and ARDS
Phase II

Early Stage Revenue Generating Immunomodulation Treatment for ARDS

CimetrA® — representing over US$ 2,500,000 in sales to date.
CimetrA® delivered 50,000 units to the USA market (Under Special Access) and over 100,000 worldwide.
Results of Preclinical and Clinical program, meeting FDA guidelines, to date:
  • Demonstrated suppression of cytokine storm in Phase II Clinical Trials1
  • Demonstrated significant reduction in C-reactive protein (CRP), a major inflammatory marker2
  • The biological markers in the blood tests further proved a reduction of inflammation, enterohepatic involvement, and liver reactant proteins1
  • Effective blocking of the IL-32mRNA expression1, the pro-inflammatory cytokine related to Autoimmune diseases,  lupus, rheumatoid arthritis, inflammatory bowel disease, asthma, and chronic obstructive pulmonary disease1
  • Preclinical studies in rodents (rats, mice) and non-rodent (swine) confirm the safety profile, with no formulation-related toxicity detected3
1) Data on file – CimetrA in-vitro study
2) Data on file – Interim results – CimetrA Dose Finding Study
3) Data on file – CimetrA pre-clinical study

Market Potential

Cases of severe illness
of influenza worldwide1
3–5M
per
annum
Respiratory
deaths
150K
per
annum
Potentially, CimetrA® can be used to treat inflammatory conditions with £100B2 total addressable market

Key Points

Sales strategy is to licence and distributes through 3rd party distribution supported by in house Medical Scientific Liaison
Key wholesaler partners in the USA and MENA — AMC
Initiate CimetrA® IND submission to the US FDA

Strategic milestones

CimetrA® IND submission to the US FDA
1) https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal)
2) https://www.precedenceresearch.com/anti-inflammatory-therapeutics-market

CogniCann®

Dementia
and Alzheimer’s
Phase II

Dementia and Alzheimer’s ​

55 million people worldwide suffering from Dementia and Alzheimer’s1
CogniCann® designed as a treatment for the symptoms associated with Dementia and Alzheimer’s
Patients in the Placebo group experienced a deterioration in their condition, compared with the stable neuropsychiatric profile of those patients in the treatment group with CogniCann®2
This important finding indicates not only improvement in the health status of the patients and also the improved quality of life of the families and caregivers taking care of dementia patients​
1) https://www.who.int/news-room/fact-sheets/detail/dementia
2) Data on file : CogniCann Phase II study, Australia