Cybin Inc. has confirmed it will acquire Small Pharma, combining to create the psychedelic industry’s largest and most advanced deuterated DMT programme.
UK-based Small Pharma is a biotechnology company focused on short-duration psychedelic therapies for mental health conditions.
The company has developed short-duration psychedelic therapies for mental health conditions, raising $63 million in capital since 2021. It has also released the first placebo-controlled efficacy results for DMT in the treatment of Major Depressive Disorder (MDD), progressing two clinical-stage DMT-based programmes, a pipeline of preclinical assets, and an IP portfolio.
Both Cybin and Small Pharma share a common goal of creating novel psychedelic-based therapeutics, and the duo’s combined DMT and deuterated DMT (dDMT) programmes together create the largest dataset of systematic research on these short-duration psychedelic molecules.
CEO of Cybin, Doug Drysdale, stated: “This transaction creates a clear market leader in novel psychedelic therapeutics.
“The synergy of Cybin’s and Small Pharma’s development programmes, intellectual property and robust datasets enhances our leadership and expertise in developing potentially best-in-class, optimised psychedelic therapeutics, and positions the combined company to generate long-term value for all stakeholders.
“Our combined portfolios, having an increased number of potential value-catalysts, also create added opportunities to support future funding activities with no added debt. We look forward to welcoming our Small Pharma colleagues into the Cybin team.”
The combined entity will have a combined 158 pending patent applications, including two allowed applications and 28 granted patents protecting the combined companies’ clinical and preclinical molecules.
CEO of Small Pharma, George Tziras, added: “This marks the beginning of an exciting new chapter for Small Pharma. Since 2015, we have been committed to our mission of accelerating patient access to transformative mental health treatments, and I am incredibly proud of the progress we have made.
“Cybin shares both our vision and confidence in the potential of our programmes.
“Cybin’s senior listing on the NYSE American can also provide increased access to the broader and deeper capital markets of the United States. We look forward to combining the considerable strengths of our teams to create a category leader in novel psychedelic-based therapeutics and bring innovative mental health treatments to patients around the world.”
Cybin and Small Pharma have stated that the integrated DMT dataset from both companies represents an advanced and extensive DMT clinical program, including:
- Phase 2 safety and efficacy data for IV DMT in patients with MDD (SPL026);
- Extensive Phase 1 dataset for IV formulations of DMT and dDMT (CYB004e, CYB004, SPL026, SPL028);
- Studies exploring more convenient and patient-friendly dosing methods (Phase 1 intramuscular SPL026 and SPL028; subcutaneous CYB004); and
- Phase 1b safety and efficacy of SPL026 administered in conjunction with serotonin reuptake inhibitors (SSRIs) in patients with MDD, with data anticipated in late 2023. Encouraging results could broaden access to DMT-based therapies by removing the requirement for patients to be withdrawn from existing SSRI medication.
Data readouts from both companies’ Phase 1 deuterated programmes, CYB004 and SPL028 are anticipated by late 2023, which will enable an evaluation of formulations and administration routes, and an informed, data-driven approach to launching a Phase 2 efficacy study of dDMT in the United States early in 2024.
Cybin expects to report Phase 2 safety and efficacy data from its CYB003 deuterated psilocybin analog programme in participants with MDD, in late 2023.
Plans are underway to scale the programme for Phase 3, including a partnership with a global clinical research organization, a streamlined EMBARK facilitator training program, and preparations for Good Manufacturing Practice (GMP) manufacturing of CYB003 capsules for pivotal clinical trial supplies.
Cybin has also stated that it anticipates the potential for receiving Breakthrough Therapy designation from the FDA, subject to FDA approval, as early as late 2023.
Once the transaction is complete, it is expected that the Small Pharma Shares will be delisted from the TSXV and removed from the OTCQB market, and Small Pharma will cease to be a reporting issuer in each of the provinces and territories in Canada.
The combined company will remain headquartered in Toronto, with operations in Canada, the US, the UK, the Netherlands, and Ireland, and will continue to trade on the NYSE American and the Cboe Canada under the ticker “CYBN”.
