Cybin Inc. (CYBN) Q2 2026 Earnings Call Transcript

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Overview

The earnings call presents mixed signals. Financial performance shows reduced net loss but increased cash outflows, indicating financial strain. Product development updates, particularly for CYB003 and CYB004, show progress but with uncertainties in trial outcomes and market engagement. The Q&A reveals management's caution in providing detailed guidance, especially concerning payer engagement and partnerships, which may concern investors. The strong liquidity position and financing provide a safety net, balancing the overall sentiment. Without a clear market cap, the neutral rating reflects the blend of optimism in development and caution in financial and strategic aspects.

Key Financial Performance

Cash-based operating expenses $28.5 million for the quarter ended September 30, 2025, compared to $18.2 million in the same period last year, representing a significant increase. The increase is likely due to expanded research and administrative activities.

Net loss $33.7 million for the quarter ended September 30, 2025, compared to $41.9 million in the same period last year, showing a reduction in net loss. This improvement may be attributed to better cost management or increased revenue.

Cash flows used in operating activities $34.5 million for the quarter ended September 30, 2025, compared to $19.1 million in the same period last year, indicating a substantial increase. This could be due to higher operational spending or investments in ongoing projects.

Operating loss $28.9 million for the quarter ended September 30, 2025. No year-over-year comparison provided, but it aligns with the overall financial performance.

Cash, cash equivalents, and investments $83.8 million as of the quarter ended September 30, 2025. This reflects a strong liquidity position, further bolstered by a subsequent $175 million financing.

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Operating Highlights

CYB003: Proprietary deuterated psilocin analog in Phase III studies for potential adjunctive treatment of major depressive disorder. Progress includes additional clearances for EMBRACE, a second Phase III study in new geographies.

CYB004: Deuterated dimethyltryptamine (DMT) program in Phase II for potential treatment of generalized anxiety disorder. Enrollment completed, with top-line data expected in Q1 2026.

Global Expansion: EMBRACE study for CYB003 cleared to commence in the U.S., U.K., EU, and Australia, targeting approximately 330 participants across 60 clinical sites.

Operational Cadence: Tightened operational cadence and disclosure discipline, with targeted talent and advisory board expertise added to support late-stage execution and launch readiness.

Manufacturing Readiness: Partnership with Thermo Fisher ensures dependable supply for Phase III and commercialization. Manufacturing footprint sized for clinic workflows.

Capital Deployment: $175 million financing secured, with funds allocated to measurable milestones, including global Phase III execution for CYB003 and database lock for CYB004.

Leadership Transition: Interim CEO Eric So stepped in following the departure of Doug Drysdale. Permanent CEO search is active.

Clinic Workflow Integration: Therapies designed for short, predictable sessions that fit within existing clinic infrastructure, aiming to reduce visit burden and increase scalability.

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Risk or Challenges

Leadership Transition: The company is undergoing a CEO transition, which could impact strategic continuity and execution. The search for a permanent CEO is still underway, and while interim leadership is in place, this could pose risks to stability and decision-making.

Regulatory Challenges: The company is advancing its programs with a conservative regulatory posture, but the need for clean study conduct, global site activation, and data quality reviews presents potential hurdles. Any delays or issues in regulatory approvals could impact timelines.

Financial Sustainability: Despite recent financing, the company reported significant cash-based operating expenses and net losses. While current resources are expected to fund operations into 2027, any unforeseen costs or delays in achieving milestones could strain financial resources.

Operational Execution: The company is scaling its clinical and manufacturing operations, but challenges in maintaining predictable therapy days, reliable supply, and efficient clinic workflows could impact the success of its programs.

Market and Competitive Pressures: The company operates in a competitive space focused on mental health treatments. Any advancements by competitors or changes in market dynamics could affect its market position and adoption of its therapies.

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Guidance & Outlook

CYB003 Phase III Program: The program is progressing as planned with dosing underway in the U.S. and global site activation in multiple countries. The study targets approximately 330 participants across 60 clinical sites, with a primary endpoint of change in MADRS total score at 6 weeks. The program aims for a Phase III top-line readout in Q4 2026.

CYB004 Phase II Program: Enrollment is complete, and the program is on track for top-line data in Q1 2026. The study evaluates two intramuscular doses with efficacy assessed at 6 and 12 weeks, and optional follow-up out to 12 months.

Manufacturing and Commercial Readiness: Manufacturing capabilities are in place with Thermo Fisher for Phase III and commercialization. The company is preparing for practical clinic workflows to ensure predictable therapy days.

Capital Deployment: The company has secured $175 million in financing, which will fund key data readouts in 2026 and operations into 2027. Capital is being allocated to measurable milestones, including global Phase III execution for CYB003 and database lock for CYB004.

Regulatory and Operational Focus: The company maintains a conservative regulatory posture, focusing on clean study conduct, global site activation, and data quality reviews as it advances towards pivotal readouts.

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Shareholder Return Plan

The selected topic was not discussed during the call.

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Key Q&A

Q:What would give confidence to move forward into Phase 3 trials for CYB004 and GAD?

A:The study is looking for directional data, a trend in change or separation between the two arms, and within-subject differences in change from baseline, especially with the threshold dose. Statistical significance would be ideal, but directional data and dose response trends are sufficient for this proof-of-concept study.

Q:What data will be shared in 1Q for CYB004?

A:HAM-A data will be shared, aiming to provide data through 12 weeks.

Q:What is the minimum durability threshold needed to compete with SPRAVATO for CYB003?

A:The agency expects data up to 12 weeks (3 months). While durability out to a year was shown in Phase II data, 12 weeks is the minimum threshold to compete.

Q:What is the statistical powering and definition of clinically meaningful HAM-A improvement for CYB004?

A:The study is not formally powered but looks for improvement from baseline within subjects and a clinically meaningful effect of around 4 to 5 points on HAM-A. A trend to difference between the two arms is also important.

Q:What operational milestones remain for CYB003 to complete enrollment in APPROACH?

A:CYB003 is on track to complete enrollment by mid-next year and deliver top-line data by the end of next year.

Q:What has been the engagement with payers for CYB003 and CYB004?

A:Preliminary market research and early payer engagement have begun, but it is still early. Both programs are expected to fit into the interventional psychiatry paradigm established by SPRAVATO.

Q:What is the status of the 45 clinical trial sites for the APPROACH trial?

A:Virtually all 45 sites are onboarded. The sites include a mix of experienced and less experienced ones in psychiatry and psychedelics. The trial remains on track to complete enrollment by mid-next year.

Q:What is the status of the preclinical CYB005 program?

A:Preclinical profiling studies are ongoing to characterize receptor profiles, brain penetration, and pharmacodynamics. Updates will be shared when available.

Q:How does the patient population in the APPROACH study differ from a TRD population?

A:The APPROACH study includes patients earlier in the treatment cycle who are inadequately responding to one or two treatments, unlike TRD patients who have failed multiple treatments.

Q:What agreement exists with the FDA regarding the safety database for CYB003?

A:The safety database requirements depend on the frequency of administration. Data from three studies will support an NDA, with additional insights from the long-term extension study.

Q:What were the details of the loan repayment to High Trail?

A:$20 million was repaid with a 10% repayment fee. The remaining $30 million was converted into equity.

Q:How important is patient compliance with background antidepressant use in the CYB003 pivotal trial?

A:Patients are required to remain on their background antidepressant medication during the treatment period.

Q:Will the pivotal program for CYB004 involve an intramuscular route of delivery?

A:Yes, the intramuscular route will be used in Phase III as it achieves the necessary plasma PK levels for therapeutic efficacy, unlike oral administration.

Q:What qualities are being sought in the incoming CEO?

A:The company seeks a CEO with a track record of capital stewardship, successful drug commercialization, and experience with big pharma transactions.

Q:Review of Unclear Management Responses

A:Management avoided providing specific details on the early payer engagement and product positioning for CYB003 and CYB004, citing that it is still early. Additionally, there was limited information on the preclinical CYB005 program and its potential partnership opportunities.

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CYBN Transcript

Cybin Inc. (CYBN) Q2 2026 Earnings Call Transcript

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