Relmada’s 2026 Q2 Call: Vague Phase II Data Timeline Clashes With Shifting Phase III Endpoint Definition

Date of Call: Aug 6, 2026

Financials Results

• EPS: Net loss of $0.11 per basic and diluted share, compared to a net loss of $0.30 per basic and diluted share for the second quarter of 2025.

Guidance:

• Plan to file the NDV-01 IND by the end of 2026 and initiate the Phase III Rescue registration program upon IND clearance.
• Expect to file the Cepranolone IND by year-end 2026 and initiate the Phase II proof of concept study upon IND clearance.
• Current cash resources are expected to fund company operations through 2029, including completion of the Phase III rescue program for NDV-01.

Business Commentary:

Manufacturing and Regulatory Progress for NDV-01:

• Relmada Therapeutics is focused on completing manufacturing for NDV-01, with plans to file an IND by year-end 2026.
• The process involves scaling up from a laboratory prototype to full GMP production, requiring coordination with supply chain partners.

Financial Position and Resources:

• The company reported cash, cash equivalents, and short-term investments of $217.7 million, up from $93 million the previous year.
• This strong financial position is expected to fund operations through 2029, covering the completion of the Phase III program.

Clinical and Regulatory Strategy:

• NDV-01 has shown 95% complete response rates and 76% durable response rates at 12 months, with favorable safety.
• The FDA has provided alignment on two planned registrational pathways, supporting the company’s move into registrational development.

Leadership and Strategic Direction:

• Bipin Dahlia has joined as Chief Business Officer, bringing extensive experience in uro-oncology and business development.
• His role includes advancing NDV-01's potential and leveraging his experience to enhance the company's strategic and commercial planning.

Research and Development Investment:

• R&D expenses for Q2 2026 totaled $8.4 million, up from $2.8 million in Q2 2025.
• The increase is due to higher costs for NDV-01 and Cepranolone studies, as well as manufacturing and drug storage.

Sentiment Analysis:

Overall Tone: Positive

• The company states it is in a 'position of strength' with a 'differentiated clinically validated asset' and 'FDA alignment on our path to registration.' Management expresses being 'very confident in this program and optimistic about Realmada's future.'

Q&A:

• Question from Uyir (Mizuho): Help us understand your role at Relmada and how you envision bringing NDV-01 to commercialization. Also, provide more color on the gating factors for manufacturing and CMC activities.
  Response: The CBO's role includes corporate strategy, commercial planning, business development, and close involvement in manufacturing. Manufacturing development is complete; the remaining focus is on executing the production schedule with the GMP manufacturer to produce scalable batches and generate stability data for the IND filing.

• Question from Farven Hawk (Jefferies): Do you need FDA input on the GMP batch prior to filing the IND?
  Response: No FDA input is needed before filing the IND.

• Question from Farven Hawk (Jefferies): How many sites are planned, and how quickly can you go from IND clearance to the first patient dose?
  Response: Approximately 80 sites (60 primary, 20 backup) are enrolled. Enrollment can technically start 30 days after IND filing, assuming clearance.

• Question from Farven Hawk (Jefferies): Do you have plans to disclose the 18-month data from the Phase II study later this year?
  Response: The focus has been on Phase III registration preparation; the 18-month data will likely be published at some point, but there is no specific plan for this year.

• Question from Kelsey Goodwin (Piper Sandler): What steps in NDV-01 IND preparation took longer than initially guided, and is the three-month CR data disclosure still on track for later this year?
  Response: The main delay was related to scheduling the GMP manufacturing, which is expected but takes time to secure a slot. The three-month CR data disclosure timing is still being evaluated; the current trend is to aim for first half of 2027, but the decision is not yet finalized.

• Question from Farven Hawk (Jefferies): In the Phase III trial, does a reinduction after disease recurrence count towards the primary complete response (CR) endpoint?
  Response: Yes, the primary endpoint is 'response at any time,' so a patient who does not respond at three months but responds at six months after reinduction would count.

• Question from Uyir (Mizuho): Is there any read-through from the FDA advisory committee outcome for Repromune to Relmada's second-line development for NDV-01?
  Response: Management declined to comment on other companies' outcomes, noting that the FDA's expectations for NDV-01 approval are based on overall response rate and durability data, not a fixed number.

Contradiction Point 1

Disclosure Timeline for 18-Month Phase II Data

Contradiction on the planned timeline for publishing Phase II data.

Kelsey Goodwin (Piper Sandler) - Kelsey Goodwin (Piper Sandler)

2026Q2: The 18-month data will be published at some point, but there is no specific timeline. - Sergio Traversa(CEO)

What steps in the NDV-01 IND preparation took longer than initially expected, and when should we expect the initial clinical data (e.g., 3-month CR) to be released? - Farzin Haque (Jefferies)

2026Q2: The 18-month data may be published later, but there is no specific plan yet. - Sergio Traversa(CEO)

Contradiction Point 2

Focus and Timeline for Initial Clinical Data Disclosure

Contradiction on the priority and focus for reporting initial clinical data.

Kelsey Goodwin (Piper Sandler) - Kelsey Goodwin (Piper Sandler)

2026Q2: The focus has been on Phase III registration preparation. The 18-month data will be published at some point, but there is no specific timeline. - Sergio Traversa(CEO)

What steps in the NDV-01 IND preparation took longer than initially expected, and when should we expect the initial clinical data (e.g., 3-month CR)? - Farzin Haque (Jefferies)

2026Q2: The timing for the initial clinical data disclosure is still being considered. The preference is to report data from a meaningful number of patients... and to focus on a more representative endpoint... rather than the less significant 3-month data. - Sergio Traversa(CEO)

Contradiction Point 3

Timing and Disclosure of Phase II Clinical Data

Contradiction on when and if 18-month Phase II data will be disclosed.

Farven Hawk (Jefferies) - Farven Hawk (Jefferies)

2026Q2: The focus has been on Phase III registration preparation. The 18-month data will be published at some point, but there is no specific timeline. - Sergio Traversa(CEO)

Will you disclose the 18-month Phase II trial data later this year? - Kelsey Gold (Piper Sandler)

2026Q1: The first three-month response and safety data from the second-line (BCG unresponsive) study is expected by the end of this calendar year or early next year. Data will be shared at a cadence of every three months into 2027. - Dr. Sergio Traversa(CEO) and Dr. Raj Pruthi(CMO)

Contradiction Point 4

Definition and Focus for Phase III Primary Endpoint

Contradiction on whether the primary endpoint is a fixed 80% CR rate or a more flexible "response at any time."

What is your main concern for the upcoming quarter? - Farven Hawk (Jefferies)

2026Q2: The primary endpoint is response at any time during the trial. - Sergio Traversa(CEO)

Does reinduction after disease recurrence in the Phase III trial count toward the primary Complete Response (CR) endpoint? - Christopher Lui (Lucid Capital Markets)

2026Q1: A positive readout would be the 80% complete response (CR) rate at 12 months in the BCG unresponsive population. - Dr. Raj Pruthi(CMO)

Contradiction Point 5

Timeline and Nature of Clinical Data Disclosure

Conflicting statements on when and how Phase II/III clinical data will be shared.

What are your thoughts on the implications of Farven Hawk's analysis from Jefferies? - Farven Hawk (Jefferies)

2026Q2: The 18-month data will be published at some point, but there is no specific timeline. - Sergio Traversa(CMO)

Are there plans to disclose the 18-month Phase II trial data later this year? - Uy Ear (Mizuho Securities)

20260320-2025 Q4: The plan is to share 3-month, 6-month, 9-month, and 12-month data from the Phase III second-line trial at intervals of about every 3 months, starting by the end of 2026. - Raj Pruthi(CMO)