Improving the lives of those suffering from Rare Disease

Join us in reducing suffering by utilising 5HTx agonists

Health problem

Pain is the most common reason people seek healthcare and a leading cause of disability in the world

Chronic Pain,The Lancet,Vol.397, No.10289 May 27, 2021

of US adults have chronic pain each year (CDC)

0 %

of people worldwide are affected by chronic pain (Lancet, 2021)

0 %

Pain Management market

$90-120bn
2027 75%
$80bn
2021 100%
CAGR: 4-7%
Est. Allied Market Research/ Mordor Intelligence

Treating chronic pain with opioids has created a crisis of its own. It’s time for a new approach

Chronic Pain,The Lancet,Vol.397, No.10289 May 27, 2021

Number of pills manufactured by the 10 biggest opioid companies (2006-2012)*

*Washington Post, 76 Billion Opioid Pills; Newly released Federal Data unmasks the epidemic', July 16, 2019 (accessed Oct 22)

Our approach

We are initially tackling a severe, rare pain condition with psilocybin. Broader chronic pain indications can be developed subsequently or in parallel with psilocybin/our proprietary 5HTx agonists.

Problem

A severe rare disease with no licensed medicine

Solution

Psilocybin may address this unmet medical need

Science

Scientific rationale for psilocybin in pain

Modulation of pain

Psychedelics like psilocybin may reduce pain by affecting brain regions involved in perception, emotion, and pain processing

Neuroplasticity

Psilocybin may promote neuroplasticity and reset the brain’s default mode network, enhancing its therapeutic potential for pain

Psychological distress reduction and effects in depression and PTSD

Psilocybin-assisted therapy may alleviate anxiety, depression, and PTSD linked to chronic pain

Anti-inflammatory effects

Psilocybin and other 5-HT2A agonists may reduce inflammation by inhibiting pro-inflammatory cytokines like TNF-α

Accomplishments

On the path to serve patients

Our manufacturing process is highly efficient; leading to low COGS and increased patient accessibiIity

NCEs & Supply Chain

Innovation & Supply Chain

natural biochemical combinations possible

90000 +

clinical trial to be initiated in target indication

NCEs to date, with provisional patent applications submitted

25

kg p/a licensed natural product production facility

18000

NCEs purified for initial preclinical testing

active natural product doses p/a cultivaton capacity

M
Binding pocket for LSD. Left hand-side main view of the pocket, Centre hydrophobicity and right hand-side depth of the pocket. This pocket accommodates the ligands and measure approx. 716 Å
Alignments binding pocket RMSD 1.06. Red surface 5hT-2A and yellow for 5HT-2B, Both LSD structures wew use display the positioning of the R-groups after the amide.

Cy Biopharma

Novel Molecules

Team

Senior executives with proven track records

Steffen Stürzebecher M.D., PhD
Serial CMO and SVP in clinical R&D with 40 years of pharmaceutical experience spanning pre-clinical and clinical research, translational medicine, medical affairs and marketing. Steffen is a board certified pharmacologist and leads Cy’s pre-clinical, clinical and regulatory R&D activities.
James Morrison LLB BCL
Law, commodities and pharmaceuticals trading. Working with national regulators to progress Cy strategy and maintain key partnerships. Researched and taught at University of Oxford and studied at the Sheffield Institute of Biotechnology Law and Ethics.

Join us on our mission to deliver

A new approach to tackling rare disease

Modulation of pain

Scientific evidence suggests that pain is a perceptual experience inferred from bodily state (i.e., embodied) and socio-environmental context (i.e., embedded in the environment in which pain is experienced). As such, an individual’s experience of pain is influenced by a wide variety of sensory, affective, cognitive, social, and bodily cues interpreted within current and evolutionary contexts. The mechanisms by which psychedelics, including psilocybin, may provide analgesia are not entirely clear. However, it has been suggested that acute psychedelic experiences that occur following the intake of psychedelics may influence activity in brain regions that are not only involved in processes that regulate emotion, cognition, memory, and self-awareness, but that are also associated with processes leading to perceptual experience of ‘embodied’ and ‘embedded’ pain (Whelan and Johnson, 2018).

Psilocin binds to several 5-HT receptors. The 5-HT2A and 5-HT2C receptors in the central nervous system are involved in peripheral and centrally mediated pain processes as well as the regulation of mood, anxiety, and cognition (Patel and Dickenson, 2018; Whelan and Johnson, 2018). The 5-HT2A and 5-HT7 receptors are involved in anti-nociceptive actions of the rostral ventromedial medulla of the descending pain inhibitory pathways that inhibit onward transmission of nociceptive information in the spinal cord (Whelan and Johnson, 2018).

The decrease in total number of cell surface 5-HT2A receptor binding sites in the brain, and
potentially the promotion of internalisation of these receptors, caused by psychedelics such as
psilocybin may also contribute to decreased signalling in pathways responsible for nociception
(Zia et al., 2023).

Neuroplasticity

Research suggests that psychedelics promote neuroplasticity and that serotonergic psychedelics, including psilocybin, increase neuritogenesis, spinogenesis, and synaptogenesis (Ly et al 2018). The concept of a reset effect on the brain’s default mode network involved in the chronification of pain by psilocybin (Whelan and Johnson, 2018; De Ridder et al, 2022) may add to the therapeutic potential.

Psychological distress reduction and effects in depression and PTSD

Pain often leads to psychological distress, including anxiety and depression, due to the persistent and
debilitating pain experienced by patients (Taylor et al 2021). Psilocybin-assisted therapy has shown potential in alleviating mood and behavioural disorders including depression and post-traumatic stress disorder (Whelan and Johnson, 2018; Perez et al 2023).

Anti-inflammatory effects

There is emerging evidence in animal models that 5-HT2A agonists have powerful anti-inflammatory effects by reducing inflammatory cascades mediated by pro-inflammatory cytokines such as tumour necrosis factor-alpha (TNF-α). This was demonstrated by the findings that activation of 5-HT2A receptors with psychedelics, including psilocybin, produces a potent anti-inflammatory effect (Flanagan and Nichols 2018; Mason et al 2023).