Relmada Therapeutics, Inc. (RLMD): Business Model Canvas [Dec-2025 Updated]

You're digging into Relmada Therapeutics, Inc. (RLMD) after a major strategic shift, and what you see isn't a revenue machine yet; it's a focused, pre-commercial clinical execution plan funded by fresh capital. Honestly, the entire business model right now hinges on managing the runway to get NDV-01 into Phase 3 and sepranolone through its Phase 2 study, using the $94 million net proceeds from their November 2025 equity offering to supplement the $13.9 million in cash they held as of September 30, 2025. This canvas maps out the key partnerships with CROs and CMOs, the high-touch scientific engagement with KOLs, and the clear, high-risk/high-reward value proposition centered on a potential best-in-class bladder cancer treatment; you need to see the full breakdown below to understand the cost structure and the path to future revenue streams.

Relmada Therapeutics, Inc. (RLMD) - Canvas Business Model: Key Partnerships

You're looking at the relationships Relmada Therapeutics, Inc. (RLMD) needs to execute its late-stage development plan, especially after the strategic pivot announced in late 2024. These partnerships are crucial for moving NDV-01 and Sepranolone forward.

Licensing Partners for Strategic Asset Acquisitions

Relmada Therapeutics, Inc. has solidified its pipeline through key acquisitions, which serve as its primary external value-driving partnerships for asset acquisition. The company completed two major asset purchases in early 2025 to strengthen its portfolio focused on oncology and CNS disorders.

• Acquired Sepranolone from Asarina Pharma AB in February 2025.
• In-licensed NDV-01 from Trigone in March 2025.

The Sepranolone transaction involved a total purchase price of €3,000,000 (or $3 million). Relmada Therapeutics, Inc. paid €2,756,000 within ten business days of the February 3, 2025, agreement, which accounted for a prior $250,000 credit from an October 25, 2024, exclusivity agreement.

Clinical Research Organizations (CROs) for Phase 2/3 trial execution

While specific CRO vendor names aren't public, the planned clinical execution timeline dictates the need for established CRO partnerships to manage large-scale trials. Relmada Therapeutics, Inc. is preparing for major enrollment phases based on recent data and regulatory alignment.

Asset	Planned Trial Stage	Target Initiation Period
NDV-01 (NMIBC)	Phase 3 registrational trial (two indications)	1st Half of 2026
Sepranolone (PWS)	Phase 2, proof of concept clinical trial	1st Half of 2026

The company is actively preparing for regulatory filings and manufacturing scale-up for the NDV-01 Phase 3 trial in the second half of 2025.

Contract Manufacturing Organizations (CMOs) for NDV-01 and sepranolone supply

Securing supply chains is a key partnership area, especially with the planned initiation of Phase 3 studies in 2026. Manufacturing activities are underway for both key assets.

• NDV-01 product supply scale-up is targeted for the 2H 2025.
• Preparations for manufacturing activities for Sepranolone are also underway.

Academic and clinical trial sites (urology, CNS) for patient enrollment

Relmada Therapeutics, Inc. relies on key clinical advisors and sites to guide trial design and execution. Dr. Yair Lotan, Chairman of the Clinical Advisory Board, is involved in presenting NDV-01 Phase 2 data. Dr. Raj S. Pruthi serves as Chief Medical Officer-Oncology. The company is focusing on high-risk and intermediate-risk NMIBC, which represents approximately 80% of new NMIBC cases annually in the United States, affecting about 54,000 people.

Financial advisor for exploring strategic alternatives like a merger

Following the discontinuation of the Reliance II and Relight Phase 3 studies in December 2024, Relmada Therapeutics, Inc. initiated a process to explore strategic alternatives. The company confirmed it was in the process of engaging a financial advisor to help with this review, which includes options like asset sales, mergers, or acquisitions. This process is running concurrently with a significant financing event in late 2025.

To support operations through 2028, Relmada Therapeutics, Inc. completed a financing round on November 5, 2025, bringing in $100 million in gross proceeds. That's a solid cash runway to fund the next steps while the strategic review is ongoing.

Finance: draft 13-week cash view by Friday.

Relmada Therapeutics, Inc. (RLMD) - Canvas Business Model: Key Activities

You're planning your next move based on Relmada Therapeutics, Inc.'s current operational focus. Here's the breakdown of the key activities driving the business model as of late 2025, grounded in the latest numbers.

Advancing NDV-01 into Phase 3 Registrational Trials in H1 2026

The primary focus is pushing NDV-01, the sustained-release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce), toward pivotal trials. Relmada Therapeutics expects to initiate the registrational Phase 3 program in the first half of 2026. This advancement is supported by compelling Phase 2 data in non-muscle invasive bladder cancer (NMIBC), a market with approximately 600,000 prevalent cases in the US. The Phase 3 program is designed to support two independent studies for approval in two separate indications.

The efficacy numbers from the ongoing Phase 2 study are what's driving this timeline:

Efficacy Metric	Result	Patient Count/Context
Overall Response Rate (ORR) at any time (9-month follow-up)	92%	Any time point
Complete Response (CR) at 9 months	85%	(17/20 patients)
Complete Response (CR) at 3 months	83%	(19/23 patients)
High-Grade Recurrence-Free Survival	89%	In papillary disease (16/18)
CR in Carcinoma in Situ	100%	(2/2 patients)

Honestly, seeing no patients progress to muscle-invasive disease or undergo radical cystectomy in the Phase 2 data is a huge de-risking factor for the program.

Executing the Phase 2 Study for Sepranolone in Prader-Willi Syndrome

Relmada Therapeutics is also preparing to execute the Phase 2, proof-of-concept clinical trial for sepranolone in Prader-Willi Syndrome (PWS) in the first half of 2026. PWS is an orphan indication with an estimated US prevalence of 20,000 patients. The company is working toward this launch by engaging the FDA on the proposed trial design and setting up the product supply chain with contract manufacturers. To date, more than 335 patients have been treated with sepranolone across various clinical trials, showing an excellent safety profile.

Securing FDA Alignment on Regulatory Pathways for Lead Candidates

A critical activity completed was securing alignment with the Food and Drug Administration (FDA) on the regulatory path for NDV-01. This alignment supports two distinct and independent registrational tracks for approval in NMIBC:

• High-risk, 2nd line BCG-unresponsive patients, where a single arm trial might be acceptable.
• Intermediate-risk patients in the adjuvant setting, which is planned as a randomized controlled trial.

Furthermore, the FDA minutes indicated that no additional non-clinical studies are required to support a 505(b)(2) New Drug Application (NDA) for NDV-01. For sepranolone, the activity involves FDA engagement to finalize the design of the PWS Phase 2 study.

Manufacturing Scale-up and Supply Chain Development for NDV-01

Operational readiness for the Phase 3 trials includes manufacturing scale-up and supply chain development, which was planned for the second half of 2025. This activity is reflected in the financial reporting, as the third quarter of 2025 saw an increase in manufacturing drug storage costs associated with the ramp up for NDV-01. The company is also setting up the product supply chain with contract manufacturers for sepranolone.

Strategic Review Process for Potential Merger or Asset Acquisition

Relmada Therapeutics commenced a process to explore strategic alternatives in December 2024 to maximize shareholder value. This process involves considering a wide range of options, including the sale of Company assets, a sale of the Company, a merger, or the acquisition of other assets or rights. The company is in the process of engaging a financial advisor to assist in this review. This strategic shift followed the discontinuation of the REL-1017 Phase 3 studies and the termination of the REL-P11 program effective May 12, 2025. The recent $100 million underwritten offering, closed on November 5th, providing net proceeds of approximately $94 million, is intended to support planned operations into 2028.

Here's a snapshot of the financial resources supporting these key activities as of the Q3 2025 report:

Financial Metric (as of 9/30/2025)	Amount	Context
Cash, Equivalents & Short-Term Investments	Approximately $13.9 million	Excludes net proceeds of ~$94M from Nov 5 offering
Net Proceeds from Nov 5, 2025 Offering	Approximately $94 million	From the $100 million underwritten offering
Net Cash Used in Operations (Q3 2025)	$6.7 million	Compared to $16.7 million in Q3 2024
Net Loss (Q3 2025)	$10.1 million	Or $0.30 per basic and diluted share

Finance: draft 13-week cash view by Friday.

Relmada Therapeutics, Inc. (RLMD) - Canvas Business Model: Key Resources

You're looking at the core assets Relmada Therapeutics, Inc. (RLMD) is banking on to drive value, especially after that recent capital raise. The resources aren't just about cash; they're heavily weighted toward proprietary science and regulatory milestones achieved late in 2025.

Financially, the company shored up its balance sheet significantly in November 2025. This is the bedrock that supports the planned Phase 3 initiations in H1 2026. Here's the quick math on the liquidity position as of the end of Q3 2025, before factoring in the new cash infusion.

Resource Category	Metric	Amount / Date
Cash Position (Pre-Financing)	Cash, equivalents, and short-term investments as of September 30, 2025	$13.9 million
Financing Event	Net proceeds from November 2025 equity offering	Approximately $94 million
Financing Event	Gross proceeds from November 2025 offering	Approximately $100 million
Runway Estimate	Cash position plus net proceeds supports planned expenses into	2028

The capital structure change is defintely a key resource, extending the runway to support planned expenses into 2028. Still, you have to watch the share count dynamics that came with that financing.

The most critical non-cash resources are the intellectual property and the clinical evidence supporting the lead candidates, NDV-01 and sepranolone. This is where the future revenue potential is locked in.

• Intellectual Property: Patents protecting NDV-01 through 2038.
• NDV-01 Clinical Data (Phase 2): 92% Complete Response (CR) rate at any time point (n=25).
• NDV-01 Clinical Data (Phase 2): 85% CR rate at the nine-month assessment.
• NDV-01 Safety: No progression to muscle-invasive disease or radical cystectomies observed in the reported data set.
• Sepranolone Focus: Preparing for a Phase 2 study in Prader-Willi Syndrome (PWS), an orphan indication with an estimated US prevalence of 20,000 patients.

Also critical is the human capital, specifically the team structure and the recent regulatory clarity. You need the right people and the right path to market.

Relmada Therapeutics, Inc. maintains an experienced Research and Development team focused on CNS and oncology indications, which is essential for executing the planned trials.

• R&D Focus: Prioritizing advancement of NDV-01 and sepranolone.
• R&D Spend: Operating discipline showed R&D expense fell to $4.04 million for Q3 2025 year-over-year.

The alignment with the FDA on the path for NDV-01 is a massive de-risking event, translating regulatory uncertainty into a concrete development plan. This is a tangible asset that lowers the perceived risk of the asset itself.

The FDA alignment confirms two distinct, acceptable registrational study paths for NDV-01 in Non-Muscle Invasive Bladder Cancer (NMIBC):

• Path 1: A single-arm registrational trial for high-grade, 2nd line BCG-unresponsive NMIBC patients.
• Path 2: A randomized controlled trial in the intermediate-risk NMIBC adjuvant setting.
• Regulatory Confirmation: The FDA indicated no additional nonclinical studies are required to support a 505(b)(2) New Drug Application (NDA).

These Phase 3 programs are expected to start in the first half of 2026.

Relmada Therapeutics, Inc. (RLMD) - Canvas Business Model: Value Propositions

You're looking at the core reasons why a physician or patient would choose Relmada Therapeutics, Inc. (RLMD) products over the existing options. It all comes down to superior clinical outcomes and a much simpler patient experience, especially for their lead oncology asset.

NDV-01: A potential best-in-class, bladder-sparing treatment for NMIBC

The value proposition here is transforming the standard of care for Non-Muscle Invasive Bladder Cancer (NMIBC), which accounts for up to 80% of new bladder cancer diagnoses annually in the United States, translating to around 54,000 cases each year. NDV-01 offers a bladder-sparing approach, which is critical given the high recurrence rates associated with NMIBC.

The clinical momentum supports this claim:

• Nine-month follow-up data showed a 92% complete response (CR) rate at any time point.
• Two patients who reached the 12-month assessment both maintained a CR.
• The CR rate in the BCG-unresponsive subpopulation was 88% at 9 months.
• Overall Response Rate (ORR) at any time point in the Phase 2 study was 90% (18/20 patients).

NDV-01: Ready-to-use, in-office administration simplifying care

The delivery method is a major differentiator, moving away from complex, lengthy procedures. The formulation allows for drug retention in the bladder for up to 10 days.

Here's how the administration simplifies care:

Feature	Metric/Detail
Administration Time	In-office, in under 10 minutes
Anesthesia Requirement	No anesthesia required
Equipment	No specialized equipment needed

This convenience, combined with the strong efficacy, positions NDV-01 to potentially become a best-in-class therapy for NMIBC.

Sepranolone: Novel mechanism for Prader-Willi Syndrome, an orphan disease

For Prader-Willi Syndrome (PWS), Relmada Therapeutics, Inc. is offering a novel mechanism targeting compulsive behaviors, which are a major challenge in this rare disorder. The US prevalence for PWS is estimated to be around 20,000 patients. Sepranolone is designed to selectively modulate GABA_A receptors by antagonizing allopregnanolone.

The development path is focused:

• Relmada Therapeutics, Inc. plans to initiate a Phase 2 proof-of-concept clinical trial in PWS in the 1st Half of 2026.
• To date, more than 335 patients have been treated with sepranolone in clinical trials, showing an excellent safety profile.

High complete response rate (92% at any time) and favorable safety profile for NDV-01

The safety data from the Phase 2 study supports the convenience proposition. Of the 36 enrolled patients receiving at least 1 dose, 22 (61%) experienced a treatment-related adverse event (AE).

Key safety details include:

• No patient experienced a $\ge$ Grade 3 Treatment-Related Adverse Event (TRAE).
• No patients discontinued treatment due to AEs.
• The most common treatment-related AE was transient uncomfortable urination (dysuria) in 62% of treatment-related cases.

The sustained efficacy, evidenced by the 92% CR rate at any time point, combined with this favorable safety profile, is the core of the value proposition for NDV-01. Finance: review Q4 2025 cash burn rate against the projected runway into 2028 by end of January 2026.

Relmada Therapeutics, Inc. (RLMD) - Canvas Business Model: Customer Relationships

You're looking at how Relmada Therapeutics, Inc. (RLMD) manages its interactions with key stakeholders following the strategic pivot away from the REL-1017 program.

High-touch scientific engagement with Key Opinion Leaders (KOLs)

Scientific engagement centers heavily on the NDV-01 program for non-muscle invasive bladder cancer (NMIBC). Data presentation at scientific forums is a key touchpoint for KOLs.

• NDV-01 Phase 2 study involved 25 patients.
• Reported 92% overall response rate (ORR) at any time in 9-month follow-up data.
• BCG-unresponsive subpopulation showed 91% complete response (CR) rate at any time.
• Data was presented at the Society of Urologic Oncology (SUO) 26th Annual Meeting on December 4, 2025.

Direct communication with clinical investigators and patient advocacy groups

Communication with investigators is driven by the successful alignment on the path forward for NDV-01, which dictates future trial structure.

Metric/Indication	Patient Population Size (Annual U.S.)	Response Rate (9-Month CR)	Trial Initiation Target
NDV-01 High-Risk, BCG Unresponsive	Approximately 8,000 patients	88% (for BCG-unresponsive subgroup)	H1 2026
NDV-01 Intermediate-Risk Adjuvant	Approximately 40,000 patients (receiving adjuvant therapy)	Data not specified for this cohort	H1 2026

The company is also advancing sepranolone for Prader-Willi Syndrome (PWS), which is Phase 2b-ready.

Transparent investor relations to maintain confidence after the REL-1017 failure

Investor relations in late 2025 focused on capital raising and demonstrating operational discipline following the discontinuation of REL-1017 studies in late 2024. The company held quarterly calls to discuss results, such as the Q3 2025 call on November 13, 2025.

Financial metrics shared provide context for the ongoing relationship management:

• Q3 2025 Net Loss was $10.09 million.
• Q3 2025 Research and Development expense was $4.0 million, down from $11.1 million year-over-year, reflecting the wind-down of REL-1017 studies.
• General and Administrative expense was $6.29 million for the quarter.
• Cash, Equivalents & Short-Term Investments as of September 30, 2025, was $13.9 million, excluding net proceeds of approximately $94.0 million from a November 5, 2025 offering.
• The offering raised gross proceeds of $100 million, priced at $2.20 per share.
• Total resources are expected to fund operations into 2028.
• Shares outstanding as of November 10, 2025, totaled 73,333,622.
• Insider activity showed 15 purchases and 0 sales by top executives in the last 6 months, including CEO Sergio Traversa purchasing shares for an estimated $952,307.

For direct inquiries, the contact point listed is Brian Ritchie at LifeSci Advisors via email at britchie@lifesciadvisors.com.

Regulatory engagement with the FDA for trial design and approval

Engagement with the U.S. Food and Drug Administration (FDA) was a critical de-risking event for the lead asset, NDV-01.

• Relmada Therapeutics announced receipt of written minutes from a Type B pre-IND meeting with the FDA on November 4, 2025.
• The FDA provided alignment supporting two independent registrational tracks for NDV-01 in NMIBC.
• The FDA indicated that no further clinical nonclinical studies are required to support a 505(b)(2) NDA.
• Phase 3 studies for both indications are planned to initiate in the first half of 2026.

Relmada Therapeutics, Inc. (RLMD) - Canvas Business Model: Channels

You're looking at how Relmada Therapeutics, Inc. gets its investigational products, like NDV-01 and sepranolone, in front of the right people-doctors and regulators. For a clinical-stage company, the channels are heavily weighted toward clinical execution and regulatory interaction right now, with commercial channels being future planning.

Clinical Trial Networks (Urology, Oncology, CNS) for Drug Development

Relmada Therapeutics, Inc. is using established clinical trial networks to advance its lead candidates. The primary focus for NDV-01 is in urology, specifically for Non-Muscle Invasive Bladder Cancer (NMIBC). The company appointed Raj S. Pruthi, MD, as Chief Medical Officer-Urology on June 17, 2025, to guide this development. Sepranolone development channels involve CNS indications, with a planned Phase 2 study initiation in Prader-Willi syndrome (PWS) in the first half of 2026. The current Phase 2 study for NDV-01 is actively enrolling, with the next step being the initiation of a Phase III registration-track study in the first half of 2026.

Here's a snapshot of the key clinical and data presentation channels as of late 2025:

Product/Indication	Network/Event Channel	Date/Status	Key Metric/Data Point
NDV-01 (NMIBC)	Phase 2 Study Enrollment	Actively enrolling (as of Q2 2025)	9-month follow-up showed 92% Complete Response Rate (CRR) at any time
NDV-01 (NMIBC)	Scientific Conference Presentation	AUA 2025 (April 28, 2025)	Presentation time: 10:04 AM PT
NDV-01 (NMIBC)	Phase III Planning	Expected initiation in H1 2026	U.S. prevalent cases targeted: ~600,000
Sepranolone (PWS)	Phase 2 Study Planning	Planned initiation in H1 2026	U.S. Estimated Prevalence (Orphan Disease): 20,000 patients

Regulatory Submission Channels (e.g., FDA 505(b)(2) NDA pathway for NDV-01)

The regulatory channel for NDV-01 is centered on the FDA's 505(b)(2) New Drug Application (NDA) pathway. Relmada Therapeutics, Inc. secured alignment with the FDA following a Type B pre-IND meeting, which is a critical step in defining the path to market. The FDA confirmed that no further non-clinical studies are required to support the 505(b)(2) NDA submission.

The FDA feedback supports two separate registrational paths, which diversifies the submission channel:

• High-grade, 2nd line BCG-unresponsive setting: A single-arm trial might be acceptable in a more refractory patient population.
• Intermediate-risk NMIBC setting: A proposal for a randomized controlled trial post-TURBT versus observation is generally acceptable.

The company expects to initiate these Phase 3 programs in the first half of 2026. To fund this, Relmada Therapeutics, Inc. completed a $100 million underwritten offering of common stock and pre-funded warrants on November 5th, supporting planned operations into 2028.

Scientific Conferences (e.g., AUA 2025) for Data Presentation and Awareness

Scientific conferences serve as a primary channel for disseminating clinical data to the medical community. Relmada Therapeutics, Inc. presented positive initial Phase 2 data for NDV-01 at the American Urology Association (AUA) 2025 Annual Meeting (AUA 2025), which took place from April 26-29, 2025. The specific data presentation occurred on April 28, 2025.

The data presented highlighted strong efficacy:

• 90% Overall Response Rate (18/20 patients) from Q1 2025 data.
• 89% High-Grade Recurrence-Free Survival in papillary disease (16/18 patients).
• 100% Complete Response in carcinoma in situ cases (2/2 patients).

The 9-month follow-up data, reported later in 2025, showed a 92% complete response rate at any time point. This data dissemination is crucial for building awareness ahead of planned Phase III trials.

Future Specialty Pharmacy and Direct-to-Physician Distribution Networks

As Relmada Therapeutics, Inc. is planning to initiate Phase III trials in H1 2026, the establishment of commercial distribution channels is a near-term requirement, though specific network details for their products are not yet public as of late 2025. NDV-01 is designed to be an in-office ready-to-use therapy that requires no anesthesia or dedicated equipment. This delivery mechanism suggests a potential direct-to-physician or specialized urology clinic channel, rather than relying solely on traditional retail pharmacies.

For specialty drugs in general, the industry trend shows that these products often require strict temperature control and specialized handling, leading to reliance on Limited Distribution Drugs (LDDs) networks or specialty pharmacies. Given NDV-01's in-office administration, the channel strategy will likely involve:

• Direct sales force engagement with urologists and urologic oncologists.
• Establishing relationships with specialty pharmacy providers for reimbursement support services, if applicable post-approval.
• Ensuring product supply scale-up is complete in the second half of 2025 to support the H1 2026 Phase III launch.

Finance: draft 13-week cash view by Friday.

Relmada Therapeutics, Inc. (RLMD) - Canvas Business Model: Customer Segments

You're looking at the specific groups Relmada Therapeutics, Inc. (RLMD) targets with its clinical pipeline as of late 2025. The focus is on distinct patient populations for its two lead candidates, NDV-01 and sepranolone, plus the financial backers funding the journey.

Urologists and Oncologists treating Non-Muscle Invasive Bladder Cancer (NMIBC)

This segment comprises the specialists who manage the treatment pathway for bladder cancer patients, particularly those with high-risk or intermediate-risk NMIBC. They are the gatekeepers for adopting NDV-01, which targets a significant unmet need due to recurrence and limitations of existing treatments like BCG.

• Urologists and Oncologists are the prescribers for NDV-01, a sustained-release formulation of gemcitabine and docetaxel.
• The overall US bladder cancer prevalence is 744,000 people living with the disease.
• NMIBC represents 75-80% of all bladder cancer cases.
• Recurrence rates over five years for NMIBC are cited as 50% to 80%.

Patients with high-risk, BCG-unresponsive NMIBC (~8,000 US patients/year)

This is the initial, high-need target for NDV-01, representing patients who have failed the standard Bacillus Calmette-Guerin (BCG) therapy. The company has secured FDA alignment for a registrational path specifically for this high-risk, second-line indication. The data from the Phase 2 study showed a 92% overall response rate at any time for the overall NMIBC cohort (n=25).

Specialists treating Prader-Willi Syndrome (PWS) (~20,000 US prevalent patients)

This segment is targeted by sepranolone, a GABAA Modulating Steroid Antagonist (GAMSA). Specialists in rare genetic disorders and neurobehavioral complications are the key prescribers here. Relmada Therapeutics plans to initiate a Phase 2 proof of concept clinical trial in PWS in the first half of 2026.

• US Prevalence for PWS is estimated at 20,000 patients.
• Global prevalence for PWS is estimated between 350,000 and 400,000 patients.
• More than 335 patients have been treated with sepranolone in clinical trials to date.

Institutional and retail investors funding the clinical development stage

This group provides the necessary capital to advance the clinical programs through milestones, such as the planned registrational studies for NDV-01 starting in the first half of 2026. The company recently bolstered its funding position to support operations into 2028.

Here's a quick look at the financial context for these investors as of late 2025:

Financial Metric	Value as of Late 2025	Date/Context
Cash, Cash Equivalents & Short-Term Investments	$13.9 million	September 30, 2025
Gross Proceeds from Recent Offering	$100 million	November 2025
Net Proceeds from Recent Offering	Approximately $94.0 million	November 2025
Cash Runway Coverage	Sufficient into 2028	Post-November 2025 financing
Market Capitalization	$310.93 million	December 5, 2025
Q3 2025 Net Loss	USD 10.09 million	Three Months Ended September 30, 2025

The total US market opportunity for NDV-01 across high-grade and intermediate-grade NMIBC is estimated at approximately 600,000 prevalent cases. The company is targeting the BCG-unresponsive segment, estimated at 8,000 patients per year, and an intermediate-risk adjuvant opportunity of about 40,000 patients.

Relmada Therapeutics, Inc. (RLMD) - Canvas Business Model: Cost Structure

Relmada Therapeutics, Inc.'s cost structure in late 2025 is heavily weighted toward Research and Development and General and Administrative functions, reflecting its clinical-stage, pre-revenue status. The company has been focusing on operating discipline, which resulted in lower expenses compared to the prior year period.

For the third quarter ended September 30, 2025, the key reported operating expenses were:

Cost Category	Q3 2025 Amount
Research and Development (R&D) expenses	$4.04 million
General and Administrative (G&A) expenses	$6.29 million

You'll note that the R&D spend was significantly lower than the $11.1 million reported in Q3 2024, while G&A also decreased from $11.86 million year-over-year.

The Research and Development expenses, totaling $4.04 million for the quarter, were driven by several factors, though the overall spend was lower due to the wind-down of costs associated with the REL-1017 trial. The remaining R&D costs included necessary investments for pipeline progression:

• Costs for manufacturing and drug supply scale-up for NDV-01 and sepranolone, which partially offset the overall R&D reduction.
• Increased R&D employee compensation expense.
• Costs associated with advancing the NDV-01 and sepranolone programs toward planned late-stage studies.

The General and Administrative expenses, reported at $6.29 million, reflected cost management, primarily through lower stock-based compensation. However, this category still absorbed costs related to ongoing operational and strategic needs:

• Consulting services expenses were a component of G&A spend.
• Costs related to financial advisory services for strategic review activities are captured within these general operating expenses.
• Increased G&A employee compensation expense partially offset the overall G&A reduction.

While specific, itemized costs for the planned Phase 3 NDV-01 and Phase 2 sepranolone studies are not broken out separately from the aggregate R&D figure, the company secured FDA alignment for the registrational paths, meaning these significant future clinical trial costs are now being planned for execution in the first half of 2026. The company closed a financing in November 2025, netting approximately $94.0 million, which is intended to support these planned expenses into 2028.

Relmada Therapeutics, Inc. (RLMD) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Relmada Therapeutics, Inc. (RLMD) right now, and honestly, it's what you'd expect for a company deep in the clinical pipeline. The current reality is that Relmada Therapeutics, Inc. has zero commercial revenue; the company is pre-commercial. This is defintely a key point for any valuation model you're building. This clinical-stage pharma company, founded back in 2004, has not sold a dime of product as of late 2025.

The immediate financial lifeblood comes from capital markets, not drug sales. You saw this play out in November 2025 when Relmada Therapeutics, Inc. successfully closed a significant equity offering. This was crucial for funding the next phase of development. Here's the quick math on that financing event:

Financing Event Detail	Amount/Date
Gross Proceeds from Offering	$100 million
Net Proceeds (Approximate)	$94 million
Closing Date	November 5, 2025
Cash as of September 30, 2025 (Excluding Net Proceeds)	$13.9 million
Projected Runway with Proceeds	Into 2028

This infusion of capital, which excludes the $13.9 million cash on hand as of September 30, 2025, is specifically earmarked to support planned operations into 2028 and drive forward the next set of clinical studies.

Beyond the immediate equity raise, the potential for non-dilutive revenue streams rests entirely on hitting clinical milestones for its two lead assets, NDV-01 and sepranolone. These are the theoretical future revenue drivers that analysts watch closely. The company is positioning these assets to address significant patient populations, which underpins the potential value of any future out-licensing or collaboration milestone payments.

Future product sales are contingent on successful regulatory approval, which is looking past 2028 for top-line data readouts. The market opportunity for these products, if approved, is substantial, based on current patient estimates:

• NDV-01 (NMIBC): Targets high-risk and intermediate-risk NMIBC, estimated to be about 8,000 BCG-unresponsive patients/year plus a 40,000-patient adjuvant opportunity.
• NDV-01 (Overall NMIBC US Prevalence): Approximately 600,000 prevalent cases.
• Sepranolone (PWS): Targets an orphan indication with an estimated US prevalence of 20,000 patients.

The company plans to initiate two registrational studies for NDV-01 and a Phase 2 study for sepranolone in the first half of 2026. Top-line timing for the NDV-01 12-month Complete Response readout is targeted around Q2 2028.