Cybin to Acquire Small Pharma Inc.

TORONTO & LONDON–(BUSINESS WIRE)–Cybin Inc. (NYSE American:CYBN) (NEO:CYBN) (“Cybin”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative psychedelic-based treatment options, and Small Pharma Inc. (TSXV:DMT) (OTCQB:DMTTF) (“Small Pharma”), a U.K.-based biotechnology company focused on short-duration psychedelic therapies for mental health conditions, today announced that they have entered into a definitive arrangement agreement (the “Agreement”) pursuant to which Cybin will acquire all of Small Pharma’s issued and outstanding securities in an all-share transaction pursuant to a plan of arrangement (the “Transaction”).

Under the terms of the Transaction, Small Pharma shareholders will receive 0.2409 common shares in the capital of Cybin (“Cybin Shares”) for each common share of Small Pharma (“Small Pharma Share”) held. The exchange ratio implies consideration of approximately $0.10 per Small Pharma Share based on the closing price of the Cybin Shares on the Cboe Canada exchange (“Cboe Canada”) on August 25, 2023, representing a 43.64% premium based on the 30-day volume weighted average prices of the Cybin Shares on the Cboe Canada and the Small Pharma Shares on the TSX Venture Exchange (“TSXV”) for the period ended on August 25, 2023. As of the date of this press release, it is expected that existing Cybin shareholders and Small Pharma securityholders will own approximately 74.5% and 25.5% of Cybin, respectively.

The Agreement has been unanimously approved by Small Pharma’s board of directors (the “Small Pharma Board”) on the unanimous recommendation of a special committee of its independent directors (the “Small Pharma Special Committee”), and Cybin’s board of directors (the “Cybin Board”).

“This transaction creates a clear market leader in novel psychedelic therapeutics. The synergy of Cybin’s and Small Pharma’s development programs, intellectual property, and robust datasets enhances our leadership and expertise in developing potentially best-in-class, optimized 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,” said​ ​Doug Drysdale, Chief Executive Officer of Cybin.

Small Pharma is a leader in the development of short-duration psychedelic therapies for mental health conditions, having raised a total of $63 million in capital since 2021, and demonstrating the first placebo-controlled efficacy results for N,N-dimethyltryptamine (“DMT”) in treating Major Depressive Disorder (“MDD”). In the past years Small Pharma has progressed two clinical-stage DMT-based programs, a pipeline of preclinical assets, and developed a highly robust intellectual property (“IP”) portfolio to protect them.

With a common goal to create novel, optimized psychedelic-based therapeutics, the combination of Cybin and Small Pharma creates an international, clinical-stage leader with the potential to transform the treatment paradigm for mental health conditions. Cybin’s and Small Pharma’s combined DMT and deuterated DMT (“dDMT”) programs creates the largest dataset of systematic research on these short-duration psychedelic molecules. The companies’ combined development portfolios are highly complementary and provide multiple opportunities to create operational and cost synergies.

The combined entity will hold the most impressive IP portfolio in the psychedelic drug development sector, with a combined 158 pending patent applications, including two allowed applications, and 28 granted patents protecting the combined companies’ clinical and preclinical molecules. This extensive IP portfolio creates an unmatched opportunity for the combined company to develop next-generation novel compounds for a number of mental health disorders that may be amenable to treatment with psychedelic therapies.

George Tziras, Chief Executive Officer of Small Pharma, said, “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 programs. 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.”

Together, the combined operating teams of Cybin and Small Pharma create a sector-leading organization with deep expertise in DMT and deuterated psychedelic tryptamine-based therapeutics for mental health disorders. 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 programs, CYB004 and SPL028 are anticipated by late 2023. This will enable a robust 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 program in participants with MDD, in late 2023. Plans are underway to scale the program for Phase 3, including a partnership with a global clinical research organization, a streamlined EMBARK^CT facilitator training program, and preparations for Good Manufacturing Practice (GMP) manufacturing of CYB003 capsules for pivotal clinical trial supplies. Cybin was recently granted a composition of matter patent covering a deuterated psilocybin analog in its CYB003 program, and anticipates the potential for receiving Breakthrough Therapy designation from the U.S. Food and Drug Administration (“FDA”), subject to FDA approval, as early as late 2023.

The combined company will be led by Cybin’s Chief Executive Officer, Doug Drysdale, who brings over 30 years of experience in the healthcare sector. Small Pharma senior management and staff will be integrated with the existing Cybin team to create a highly experienced and skilled team that is well positioned to deliver on the development and clinical execution of the combined pipeline.