Cybin's 2026 Q2 Earnings Call: Contradictions Emerge on Payer Engagement, FDA Guidance, and Dosing Strategies for CYB003/CYB004

Date of Call: November 13, 2025

Financials Results

• EPS: -$1.39 per basic and diluted share (net loss $33.7M) vs net loss $41.9M in the same period last year

Guidance:

• CYB004 top-line data expected in Q1 2026 (HAM-A through 12 weeks intended).
• CYB003 Phase III top-line expected in Q4 2026 (continue dosing, EMBRACE site activations).
• Cash + $175M financing expected to fund key 2026 data readouts and operations into 2027.
• Continue manufacturing and commercial readiness work and pace capital to milestones.
• CEO search active; will provide updates when complete.

Business Commentary:

* Lead Programs and Clinical Progress: - Cybin's lead programs, CYB003 and CYB004, are advancing with CYB003 in Phase III and CYB004 in Phase II, with key milestones expected in late 2026. - The progress is attributed to the company's focus on patient-focused rigorous science, disciplined education, and clear communication.

• Financial Strength and Capital Deployment:
• Cybin's cash-based operating expenses for Q2 increased to $28.5 million, reflecting research and general administrative costs.

• This was supported by a recent $175 million financing, which has provided flexibility for executing upcoming milestones.

• Regulatory Milestones and Strategy:

• Cybin's CYB003 program received clearance to commence the EMBRACE study in multiple countries, expanding its global footprint.

• The strategy is driven by a conservative and specific regulatory posture, focusing on clean study conduct and data quality.

• Payer Engagement and Market Positioning:

• Early engagement with payers has begun for both CYB003 and CYB004, indicating potential integration into the emerging interventional psychiatry paradigm.

• Cybin's programs are positioned to address resource-intensive patients, complementing existing treatments like SPRAVATO.

• Manufacturing and Commercial Readiness:

• Cybin has established manufacturing partnerships with Thermo Fisher, ensuring supply for Phase III and commercialization.
• This supports a practical clinic workflow and is key to scaling capacity as data matures and regulatory milestones are achieved.
  

  Sentiment Analysis:

  Overall Tone: Positive

  • Management emphasized strengthened balance sheet after a $175M registered direct offering and full retirement of convertible debentures; "we expect our cash resources to fund key data readouts in 2026 and fund operations into 2027." Multiple statements stressed execution toward upcoming pivotal readouts and manufacturing/commercial readiness.

Q&A:

• Question from Pete Stavropoulos (Cantor Fitzgerald): On CYB004 (GAD) you completed enrollment of 36 patients and expect a Q1 '26 readout—what would give you confidence to progress to P3 (statistical significance vs directional/dose‑response), and will you report 6‑week HAM‑A or 12‑week data in 1Q?
  Response: Looking for directional separation and dose‑response (threshold vs low dose); the study is proof‑of‑concept (not formally powered); will aim to report HAM‑A through 12 weeks, and statistical significance would be welcome but is not required to be informative.

• Question from Pete Stavropoulos (Cantor Fitzgerald): Based on P2 CYB003 durability (remission up to a year after 2 doses), what is the minimum durability threshold needed to compete with SPRAVATO and how do you weigh durability versus clinic time/payer perspective?
  Response: Regulators expect data to 12 weeks as a minimum; company would be thrilled with effects maintained to 12 weeks but is aiming for longer durability (Phase II showed up to 12 months).

• Question from Patrick Trucchio (H.C. Wainwright): For CYB004, what should we expect on statistical powering and what constitutes a clinically meaningful HAM‑A improvement? Separately, what operational milestones remain to complete enrollment in APPROACH and status of site activations?
  Response: CYB004 is not formally powered; a clinically meaningful HAM‑A change is ~4–5 points and a trend/dose‑response is important; APPROACH is tracking to plan—on target to complete enrollment by mid‑next year and deliver top line by year‑end.

• Question from Patrick Trucchio (H.C. Wainwright): How are you engaging payers now and how do you expect to position CYB003/CYB004 vs SPRAVATO and other therapies?
  Response: Preliminary payer engagement has begun but it's early; both programs are being positioned to fit the interventional psychiatry model (intermittent, clinic‑based treatments) where SPRAVATO already created infrastructure.

• Question from Jim Molloy (Alliance Global Partners): For APPROACH you plan ~45 U.S. sites—what were criteria for site selection, activation process, and timing for full activation?
  Response: Sites mix experienced psychedelic and general CNS trial sites; nearly all 45 sites are onboarded and the study remains on track to complete enrollment by mid‑next year with top line by year‑end.

• Question from Jim Molloy (Alliance Global Partners): Status of preclinical CYB005 and any partnership discussions?
  Response: Preclinical profiling (receptor profile, brain penetration, PD) is ongoing across candidate compounds; no partnership details to share—will disclose when data are available.

• Question from Eddie Hickman (Guggenheim): How much visibility do you have into blinded baseline patient characteristics in APPROACH and how does this population differ from a TRD population? Also, what is agreed with FDA on the safety database for CYB003 and are retreatment counts in EXTEND a minimum requirement?
  Response: Only blinded quality checks are possible and so far no flags; APPROACH enrolls earlier‑line inadequate responders (failed ~1 treatment) unlike later‑line TRD; BTD discussions indicate pooled safety across the three studies should support an NDA, but final retreatment expectations depend on long‑term extension findings.

• Question from Elemer Piros (Lucid Capital Markets): How much was repaid to High Trail and what was the prepayment penalty/early repayment fee?
  Response: Repaid $20M to High Trail with a 10% repayment fee; remaining ~$30M of the original facility had converted.

• Question from Sumant Kulkarni (Canaccord Genuity): On CYB003, how important is compliance with background antidepressants during the pivotal program? On CYB004, will you pursue IM in pivotal and what are oral development challenges? And what qualities are must‑haves for the incoming CEO?
  Response: APPROACH requires patients to remain on their background antidepressant throughout treatment; CYB004 will progress with intramuscular dosing for Phase III because oral PK doesn't reach necessary exposures; the CEO must be a disciplined capital steward with prior product launch/commercialization and big‑pharma engagement experience.

Contradiction Point 1

Engagement with Payers and Market Positioning

It involves the company's strategy and timeline for engaging with payers and positioning its therapies in the market, which are critical for market adoption and revenue generation.

What is your payers engagement, and how will you position CYB003 and CYB004 relative to SPRAVATO? - Patrick Trucchio (H.C. Wainwright & Co, LLC, Research Division)

2026Q2: Early engagement has begun, but it's premature to discuss specifics. Both programs fit into the interventional psychiatry model that SPRAVATO pioneered, addressing resource-intensive patient needs. Market research indicates potential for these programs to integrate well. - [George Tziras](CMO)

When can we expect a partnership for CYB005, and who would be an ideal partner? - Andrew Partheniou (Stifel)

2022Q3: We're not spending a lot of time thinking about the payor environment. That's a challenge for all companies in this space. But we've been working with payors and, obviously, in that we've seen some of the trends that are emerging. And in the wake of the launch of SPRAVATO, we've had good conversations about where we think these treatments could fit. - [Douglas Drysdale](CEO)

Contradiction Point 2

FDA Interaction and Guidance

It involves updates on interactions with the FDA and expectations around regulatory guidance, which are crucial for the development and approval of the company's therapies.

What key results from CYB004 and GAD studies would justify advancing to Phase 3 trials - statistical significance on primary endpoints or directional improvement data? And for Q1 disclosures, will you share 6-week HAM-A primary endpoint data or 12-week efficacy results? - Sarah James (Cantor Fitzgerald)

2026Q2: We have had some interactions with the FDA on this program, but we've not met with them in terms of a formal meeting on 003. On the guidance, it's uncertain when we'll see it, but it could come as more Phase II studies provide more data. - [Douglas Drysdale](CEO)

Can you characterize your interactions with the FDA? Do you expect the FDA to issue informal guidance on psychedelic therapeutics? - Sumant Kulkarni (Canaccord)

2022Q3: We haven't had interactions with the FDA on this program specifically, but we've had interactions with the FDA on other programs that we're bringing forward. The FDA has indicated that they would be open to new approaches to bring forward for the treatment of these conditions. - [Douglas Drysdale](CEO)

Contradiction Point 3

Dosing and Administration of CYB004

It involves the method of administration and dosing for CYB004, which are critical for the efficacy and patient experience of the therapy.

What statistical power and clinically meaningful HAM-A improvements can we expect for CYB004? What operational milestones remain for completing enrollment in APPROACH and tracking site activations to plan? - Patrick Trucchio (H.C. Wainwright & Co, LLC, Research Division)

2026Q2: CYB004 isn't a fully powered study, but we look for a Within-Subject improvement of 4-5 points on HAM-A, which would be clinically meaningful. A trend in separation between arms would be beneficial. - [Amir Inamdar](CEO)

When will CYB003 trial updates be available, and will patients be followed beyond six weeks? - Charles Duncan (Cantor Fitzgerald)

2022Q3: We'll use a true placebo, and the study will be fully blinded to maintain trial integrity. - [Douglas Drysdale](CEO)

Contradiction Point 4

Dosing Duration and Repetition

It involves changes in the company's approach to dosing duration and repetition, which could impact the perceived efficacy and safety of their product candidates, affecting regulatory approval and market perception.

What statistical power and clinically meaningful improvement in HAM-A can we expect from CYB004? - Patrick Trucchio (H.C. Wainwright & Co, LLC, Research Division)

2026Q2: CYB004 isn't a fully powered study, but we look for a Within-Subject improvement of 4-5 points on HAM-A, which would be clinically meaningful. A trend in separation between arms would be beneficial. - [Amir Inamdar](CEO)

Can you explain the dose ranges and cohort designs for CYB003's clinical development program? - Patrick Trucchio (H.C. Wainwright)

2022Q2: We're contemplating multiple dose cohorts in Phase II, given the recent Phase II data from psilocybin. - [Doug Drysdale](CEO)

Contradiction Point 5

Preclinical Development and Timeline

It involves changes in the company's preclinical development plans and timelines, which could impact the overall development timeline and regulatory approval for product candidates.

What is the status of the preclinical 005 program and potential partnership opportunities? - Laura Suriel (Alliance Global Partners)

2026Q2: We're doing preclinical profiling on CYB005 compounds for neuropsychiatric conditions. The work is ongoing, and we'll share updates as necessary. - [Amir Inamdar](CEO)

Are there any additional preclinical requirements before initiating clinical trials for CYB003? - Sumant Kulkarni (Canaccord)

2022Q2: We have about 10 preclinical studies ongoing, and the material and CROs are in place. We expect to complete these studies in the first quarter of 2022. - [Doug Drysdale](CEO)