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

You're looking at a company that completely flipped the script in 2025, moving from pure research to actually selling a drug, and the results are sharp. Soleno Therapeutics, Inc. executed a stunning turnaround with VYKAT XR, securing $66.0 million in net product sales by Q3 2025, all while sitting on $556.1 million in cash. This isn't just about a new product; it's about a high-touch, premium orphan drug model priced near $466,000 annually, targeting a specific rare disease need that already has 494 unique prescribers engaged. Dive into the nine blocks below to see exactly how they built this commercial engine and what it means for their next move.

Soleno Therapeutics, Inc. (SLNO) - Canvas Business Model: Key Partnerships

You're looking at the partners Soleno Therapeutics, Inc. needs to get VYKAT XR from the lab bench to the patient's hand, especially now that they've hit profitability in the third quarter of 2025.

Specialty pharmacy network for VYKAT XR distribution

The distribution backbone relies on securing payer access, which is a partnership in itself. As of September 30, 2025, Soleno Therapeutics reported that VYKAT XR had coverage for over 132 million lives in the U.S.. This broad access is critical for the specialty pharmacy network to effectively dispense the product.

Here are some key adoption metrics tied to that distribution reach through the third quarter of 2025:

To be fair, the industry trend shows that 34% of specialty drugs had an exclusive dispensing network as of January 2025, so the exact structure Soleno uses with its specialty pharmacies isn't public, but the covered lives number shows significant payer engagement.

Contract Manufacturing Organizations (CMOs) for drug production

While Soleno Therapeutics achieved profitability in the third quarter of 2025, the manufacturing relationship is key to scaling supply. Before FDA approval on March 26, 2025, manufacturing costs were expensed as Research and Development (R&D). For instance, R&D expenses in the first quarter ended March 31, 2025, were $13.5 million. Post-launch, the cost of goods sold (COGS) for VYKAT XR was reported at $1.1 million for the third quarter of 2025.

Patient advocacy groups for rare disease awareness

Partnership with advocacy groups is essential for a rare disease like Prader-Willi Syndrome (PWS), which affects an estimated 1 in 15,000 live births. Soleno Therapeutics highlighted its commitment to working together with the community.

Key advocacy collaborations include participation in the joint conference:

• Prader-Willi Syndrome Association | USA (PWSA | USA)
• Foundation for Prader-Willi Research (FPWR)
• International Prader-Willi Syndrome Organisation (IPWSO)

The lived experience of families is critical to understanding the disease's impact.

Clinical research organizations (CROs) for ongoing trials

The R&D spend reflects ongoing investment in personnel and new programs, which includes managing relationships with CROs for clinical trials. Research and development expenses for the first quarter ended March 31, 2025, totaled $13.5 million. The company's filings note that reaching agreements with prospective CROs is a factor that can cause delays in clinical trials.

Finance: draft 13-week cash view by Friday.

Soleno Therapeutics, Inc. (SLNO) - Canvas Business Model: Key Activities

You're focused on the core actions Soleno Therapeutics, Inc. is taking right now to make VYKAT XR a success in the rare disease space. Here's the breakdown of what they're actively doing, grounded in the numbers from late 2025.

Commercialization and launch of VYKAT XR in the U.S.

The primary activity is driving the adoption of VYKAT XR, which got the green light from the FDA on March 26, 2025, and became commercially available on April 14, 2025. Soleno Therapeutics is targeting the approximately 10,000 diagnosed U.S. patients fitting the label criteria for VYKAT XR treatment. The initial uptake has been strong, showing real movement in the market.

Here's a look at the commercial traction through the third quarter of fiscal year 2025:

Financially, this commercial push translated quickly. For the three months ended September 30, 2025, Soleno Therapeutics reported:

• Product revenue, net: $66.0 million.
• Net income: $26.0 million, marking its first profitable quarter.

This Q3 product revenue more than doubled sequentially from the $32.7 million reported for the three months ended June 30, 2025. Honestly, seeing profitability this fast after launch is a major operational win.

Manufacturing and supply chain management for a rare disease drug.

Managing the supply chain for a newly launched, rare disease therapy requires tight control. The costs associated with this activity show fluctuations as they scale up production to meet demand.

The cost of goods sold (COGS) reflects the sales volume:

• For the three months ended June 30, 2025, COGS was $0.7 million.
• For the three months ended September 30, 2025, COGS increased to $1.1 million.

In terms of expense tracking, costs in support of supply chain activities decreased by $0.8 million between comparable periods leading up to the third quarter of 2025, following a decrease of $0.3 million leading up to the second quarter of 2025. The cadence of manufacturing projects is definitely tied to regulatory filing support.

European regulatory submission (MAA) for VYKAT XR.

Soleno Therapeutics is actively pursuing market access outside the U.S. The company submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval for DCCR (VYKAT XR) in the E.U. during the second quarter of 2025. The EMA subsequently validated this MAA submission.

Key financial and status points for this activity include:

• Soleno Therapeutics incurred $0.6 million in the three months ended June 30, 2025, towards the MAA submission.
• The drug already holds Orphan Drug designation in the European Union.

The company estimates around 9,500 individuals in the UK, Germany, Italy, Spain, and France are affected by Prader-Willi Syndrome.

Post-marketing surveillance and long-term clinical studies.

Even post-approval, Soleno Therapeutics continues to generate and present data to support the drug's profile. This involves ongoing analysis of patients from the initial clinical programs and data presentations at key medical conferences.

Data shared as of late 2025 confirms long-term use:

Analysis of Phase 3 study participants showed that the highly food-restricted group exhibited statistically significant (p ≤ 0.0001), clinically meaningful reductions in HQ-CT Total scores that were often numerically greater than those observed in the less restricted group at all post-baseline timepoints through Year 3. Furthermore, data presented at the 2025 United in Hope Conference showed VYKAT XR can be administered safely to individuals with pre-diabetes or diabetes.

Finance: review Q4 cash burn projections based on Q3 operating cash generation of $43.5 million by next Tuesday.

Soleno Therapeutics, Inc. (SLNO) - Canvas Business Model: Key Resources

You're looking at the core assets Soleno Therapeutics, Inc. has right now to drive the VYKAT XR launch and future growth. These aren't just line items; they are the tangible and intangible advantages that underpin the entire business structure as of late 2025.

VYKAT XR (diazoxide choline) Intellectual Property and Patents

The protection around VYKAT XR is multi-layered, which is critical for a first-in-class therapy. Soleno Therapeutics has a patent portfolio that includes both granted patents and pending applications covering the drug. Specifically, the expiration dates for the issued U.S. patents span from 2025 to 2035.

To be clear, some foundational patents, like the '777 polymorph patent and the '202 preparation patent, are slated to expire around 2026, which is quite soon. However, the company also holds other patent families that extend protection out to roughly 2034 or 2035. The company highlights that its IP provides composition of matter protection, as well as protection for formulations and method of use, with potential for substantial patent term extension into the mid-late 2030s.

Significant Cash Reserves of $556.1 million as of Q3 2025

Liquidity is a massive resource, especially during a commercial launch phase. Soleno Therapeutics ended the third quarter of 2025, on September 30, 2025, with $556.1 million in cash, cash equivalents, and marketable securities. This strong balance sheet ensures they are capitalized to execute the U.S. launch of VYKAT XR.

Here's a quick look at the cash position and recent activity:

This financial strength is a direct result of the successful launch, as Q3 2025 product revenue hit $66.0 million.

Orphan Drug Designation (ODD) and Market Exclusivity

Regulatory status provides a critical, time-bound barrier to entry. VYKAT XR has received Orphan Drug Designation in both the U.S. and the EU for treating hyperphagia in Prader-Willi Syndrome (PWS). The U.S. FDA approval occurred on March 26, 2025.

The ODD in the U.S. grants seven years of FDA-approved exclusivity, meaning generic competition is blocked until 2032, regardless of patent strength before that date. If the Marketing Authorization Application (MAA) is approved in the EU, Soleno Therapeutics could secure up to 10 years of market exclusivity there. The company also secured Breakthrough and Fast Track designations in the U.S..

Specialized Commercial Sales and Medical Affairs Team

The ability to commercialize VYKAT XR relies on the team built to support its launch. Soleno Therapeutics assembled a commercial team, led by Chief Commercial Officer Meredith Manning, in anticipation of FDA approval. The investment in this team is evident in the operating expenses.

The build-out required significant hiring, with personnel and associated costs increasing by $6.4 million in the third quarter of 2025 alone due to staffing for the commercial launch and increased business activities. Furthermore, new program costs supporting the commercial launch, which include medical affairs activities and disease state education, increased by $6.8 million for the three months ended June 30, 2025, compared to the prior period.

The leadership structure was also recently reinforced in November 2025 with the additions of Dr. Joshi as Chief Development Officer and Mr. Norrett as Chief Business Officer, both bringing extensive rare disease and commercialization experience.

• VYKAT XR indicated for patients 4 years of age and older with PWS.
• The company received 646 patient start forms from 295 unique prescribers between approval (March 26, 2025) and June 30, 2025.
• The U.S. commercial availability of VYKAT XR began on April 14, 2025.
• CEO Anish Bhatnagar, MD, was recognized by TIME Magazine as one of the 100 Most Influential People in Health for 2025.

Soleno Therapeutics, Inc. (SLNO) - Canvas Business Model: Value Propositions

You're looking at the core reason Soleno Therapeutics, Inc. (SLNO) has seen such a dramatic shift in its market position following the March 26, 2025, U.S. Food and Drug Administration (FDA) approval of VYKAT XR. The value proposition here isn't just a new drug; it's the first-ever targeted solution for a devastating, chronic condition.

The primary value is being the first and only FDA-approved therapy for hyperphagia in Prader-Willi Syndrome (PWS). Before VYKAT XR, families were essentially managing the most life-limiting symptom-the incessant hunger-with constant, 24/7 supervision. This approval, which made the drug available in the U.S. beginning in April 2025, immediately establishes Soleno Therapeutics, Inc. as the sole provider addressing this critical unmet need.

The product itself delivers on convenience and severity of need. It is a once-daily oral treatment for a life-threatening, chronic symptom. This ease of use, compared to potentially complex regimens, is a major benefit for caregivers and patients alike. The clinical data supported this value, showing that patients who switched to a placebo experienced a statistically significant worsening of hyperphagia compared to those who remained on VYKAT XR. Furthermore, the drug demonstrated demonstrated efficacy in reducing hyperphagia and improving body composition, specifically showing nominally significant reductions in fat mass as assessed by investigators in the Phase III DESTINY-PWS trial.

This unique market position supports a high-value, premium-priced orphan drug model. The anticipated list price is set to reflect the severity of the disease and the lack of alternatives. Specifically, the projected cost is approximately $466,000 per year. To be precise, the list price was set at $5.92 per milligram, and based on the average baseline weight of 61 kilograms from the C601 phase III study, the average annual cost to insurers was calculated to be $466,200. Honestly, for a rare disease with such a high burden, that price point is what you'd expect for a first-in-class orphan drug.

The early commercial uptake data already validates this value proposition in the market. As of September 30, 2025, Soleno Therapeutics, Inc. reported significant initial traction:

• 1,043 patient start forms received since approval on March 26, 2025.
• 764 active patients on the drug.
• 494 unique prescribers.

This translated quickly to financial performance, with Q3 2025 net revenue from VYKAT XR hitting $66.0 million, leading to a positive net income of $26.0 million for that quarter alone. The underlying operational efficiency is clear, too, with a reported gross margin of 98.1%.

Here's a quick look at the commercial metrics as of the end of Q3 2025:

The value proposition is therefore a trifecta: it's the only approved therapy, it addresses a life-threatening, chronic symptom with a convenient oral dose, and it commands a premium price justified by the clinical breakthrough and orphan designation. Finance: draft 13-week cash view by Friday.

Soleno Therapeutics, Inc. (SLNO) - Canvas Business Model: Customer Relationships

You're looking at the relationship Soleno Therapeutics, Inc. (SLNO) builds with the very specific, small group of people who need VYKAT™ XR, their first commercial product approved on March 26, 2025. For a rare disease like Prader-Willi Syndrome (PWS), the relationship isn't just about selling a drug; it's about becoming a trusted partner in a community with a massive unmet need.

High-touch, specialized patient support programs (PSP)

Soleno Therapeutics, Inc. deploys a high-touch model, centered around their patient support program, Soleno One™. This program is designed to streamline the navigation of insurance and distribution hurdles, which is critical for a high-cost therapy in a fragile patient population. The company's commitment to accessibility is evident in the resources allocated to these support structures. For instance, new program costs associated with commercial launch, which include disease state education and medical affairs activities, increased by $8.6 million in the third quarter of 2025 alone. This spend directly supports the infrastructure needed to keep patients on therapy.

Dedicated reimbursement support for high-cost therapy

Securing broad and rapid payer coverage is fundamental to the success of VYKAT XR. Soleno Therapeutics, Inc. has executed a proactive engagement strategy to communicate the compelling clinical value proposition. By the end of the third quarter of 2025 (September 30, 2025), the company reported that payer policies provided coverage for over 132 million lives in the United States. This coverage spans commercial, Medicaid, and Medicare channels, which is considered rapid and broad when compared to other recent rare disease launches. This robust access directly translates to fewer access barriers for the patient and prescriber.

Direct engagement with rare disease specialists and prescribers

The engagement strategy focuses on deep interaction with the small pool of clinicians who treat PWS. Soleno Therapeutics, Inc.'s field force prioritizes these top-tier providers to build confidence in VYKAT XR. The results of this targeted engagement are clear in the adoption metrics since the drug's approval on March 26, 2025.

Here's a look at the commercial traction metrics that reflect this direct engagement through September 30, 2025:

The company noted that over 50% of the top 300 healthcare providers treating PWS had submitted start forms by the end of Q3 2025. This shows the sales and medical affairs teams are successfully reaching the key influencers in the PWS treatment landscape.

Building defintely strong trust within the PWS patient community

Trust in the rare disease space is built on scientific credibility and visible commitment to the community beyond just the approved product. Soleno Therapeutics, Inc. demonstrated this commitment by having a significant presence at the 2025 United in Hope: International Prader-Willi Syndrome Conference in June 2025, presenting one oral and six poster presentations covering long-term efficacy and emotional impact. Furthermore, in October 2025, the company announced plans to invest up to $5 million in grant funding over the next year to support innovative genetic research aimed at identifying a potential cure for PWS. This level of investment signals a long-term dedication to the patient population.

The community's response is reflected in the patient start forms received, showing an urgent need for a treatment option:

• Total patient start forms received from launch through September 30, 2025: 1,043.
• Active patient count as of September 30, 2025: 764.
• The drug addresses hyperphagia, the life-threatening hallmark symptom of PWS.
• Data presented included long-term efficacy results from over 100 patients on therapy for greater than one year.

The relationship is one of necessity and shared mission. Finance: draft 13-week cash view by Friday.

Soleno Therapeutics, Inc. (SLNO) - Canvas Business Model: Channels

You're looking at the commercialization pathways Soleno Therapeutics, Inc. is using to get VYKAT XR to Prader-Willi syndrome (PWS) patients as of late 2025. For a single-asset, rare disease company, the channel strategy has to be incredibly focused, which is what we see here.

Specialty Pharmacy Distribution Channel for VYKAT XR

Soleno Therapeutics, Inc. is relying on a limited distribution model, typical for a newly approved orphan product. The distribution channel is anchored by a single, specialized partner.

• PANTHERx® Rare was selected as the specialty pharmacy for the distribution of VYKAT™ XR (diazoxide choline extended-release tablets).
• PANTHERx Rare focuses exclusively on rare and orphan diseases, providing access and support services.
• The product launched in the U.S. on April 10, 2025.

Direct Sales Force Targeting PWS Treatment Centers and Prescribers

The commercial infrastructure is built around reaching the specialized centers and the growing number of prescribers. The initial uptake metrics show how this targeted approach is performing against the estimated U.S. patient population.

Here's a look at the early adoption metrics following the launch:

The sales force is clearly expanding its reach beyond the initial key opinion leader (KOL) centers, with over 50% of the top 300 healthcare providers submitting start forms by Q3.

Digital and Medical Education Platforms for Physician Outreach

Soleno Therapeutics, Inc. is using community engagement and scientific platforms to support the prescribing community. They are committed to partnering with PWS advocates and healthcare providers to facilitate education on the VYKAT XR clinical profile.

• Presented research findings at the 2025 United In Hope: International Prader-Willi Syndrome Conference, with one oral and six poster presentations.
• The company is focused on educating the broader prescribing community on the FDA-approved clinical profile.

Payer and Formulary Access Negotiations for Coverage

Securing broad payer coverage is a critical channel component, especially in a rare disease market where reimbursement hurdles can stall access. Soleno Therapeutics, Inc. has made significant progress here.

The payer access landscape as of late 2025 shows strong momentum:

• Policies now cover approximately 132 million lives as of the end of the third quarter of 2025.
• This includes coverage policies with appropriate criteria from the top three national PBMs.
• Coverage spans all key channels: commercial, Medicaid, and Medicare, with a strong uptick in state Medicaid reimbursement.
• In Q2 2025, coverage was reported at 33% of insured lives, representing over 100 million individuals.

This broad access is designed to reduce friction for patients and support more predictable cash flows.

Soleno Therapeutics, Inc. (SLNO) - Canvas Business Model: Customer Segments

You're looking at the core group Soleno Therapeutics, Inc. (SLNO) is serving with VYKAT XR, the first and only FDA-approved therapy for hyperphagia in Prader-Willi Syndrome (PWS). This is a highly focused, niche market, but the need is profound, so the initial adoption metrics are what really matter here.

The primary customer segment is the patient population itself. Soleno Therapeutics, Inc. (SLNO) is targeting patients aged 4 years and older with genetically confirmed PWS. To give you a sense of the addressable market, the Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births, with estimates suggesting 15,000-20,000 PWS patients in the U.S..

The second critical segment is the caregivers and families managing the severe, life-limiting hyperphagia associated with PWS. Their decision-making process is heavily influenced by the drug's safety profile and accessibility, especially given the chronic nature of the condition, with some patients on therapy for greater than six years. The company's patient support program, Soleno One™, is designed to help this group navigate the hurdles of access.

The third segment involves the rare disease specialists and endocrinologists who are the gatekeepers for prescribing VYKAT XR. These are the professionals who must be convinced of the clinical benefit to write the initial script. The adoption here has been quite strong since the drug's approval on March 26, 2025. Soleno Therapeutics, Inc. (SLNO) reported reaching 494 unique prescribers by the end of the third quarter of 2025.

Here's a quick look at the commercial traction metrics as of September 30, 2025, which shows how these segments are engaging with the product:

The financial reality for this segment is supported by broad payer access. Soleno Therapeutics, Inc. (SLNO) achieved coverage for VYKAT XR across approximately 132 million lives by the end of Q3 2025. This access is vital, especially considering the drug's price point, which has been reported in the $1,000-$2,000 per month range.

You can also see the engagement level through the prescriber base. By Q2 2025, there were 295 unique prescribers, showing a significant ramp-up to the 494 unique prescribers reported by Q3 2025. The initial patient onboarding shows that, from approval through September 30, 2025, 1,043 patient start forms were received, leading to 764 active patients on the drug.

The key groups driving the business are:

• Patients aged 4 years and older with genetically confirmed PWS.
• Caregivers and families managing severe, life-limiting hyperphagia.
• Rare disease specialists and endocrinologists (494 unique prescribers by Q3 2025).
• Payers providing coverage for over 132 million lives.

Finance: draft 13-week cash view by Friday.

Soleno Therapeutics, Inc. (SLNO) - Canvas Business Model: Cost Structure

You're looking at the costs Soleno Therapeutics, Inc. is incurring now that VYKAT XR has launched, which is a big shift from the pre-commercial R&D focus. The cost structure reflects significant investment in building out the commercial engine, so you'll see those operating expenses jump right up.

The Selling, General and Administrative (SG&A) line is definitely high as the company scales up its sales and marketing presence following the FDA approval on March 26, 2025. This spending is necessary to get the drug to patients with Prader-Willi syndrome (PWS).

Here's a quick look at the major cost components for the three months ended September 30, 2025:

The SG&A increase is directly tied to the commercialization efforts for VYKAT XR. Honestly, you'd expect this spike when moving from clinical trials to market access.

• Personnel and associated costs increased by $6.4 million due to hiring for the commercial launch.
• New program costs, including disease state education, analytics, and medical affairs, increased by $8.6 million.
• The total SG&A of $33.8 million for Q3 2025 included $7.8 million in non-cash stock-based compensation.

Research and Development (R&D) expenses are still present, though lower than the prior year, reflecting the transition of VYKAT XR manufacturing costs out of R&D and into COGS now that the product is approved. For the third quarter of 2025, R&D was $8.4 million, down significantly from $30.1 million in Q3 2024. This R&D spend supports pipeline expansion and other projects.

Regarding Cost of Goods Sold (COGS), it hit $1.1 million in Q3 2025, compared to zero in Q3 2024, driven by the sales of VYKAT XR. You should note that prior to FDA approval, manufacturing costs were expensed as R&D, so as the company sells through that zero-cost inventory, the COGS as a percentage of revenue will defintely rise over time.

Regulatory compliance and quality assurance costs are embedded within these figures. Specifically, the shift of manufacturing costs from R&D to COGS after the March 26, 2025 approval is a direct consequence of meeting post-marketing regulatory and quality requirements for the commercial product. The company also has contingent consideration liabilities related to the Essentialis merger, which are fair-valued, estimated at $19.5 million as of September 30, 2025, tied to future commercial milestones.

Finance: draft 13-week cash view by Friday.

Soleno Therapeutics, Inc. (SLNO) - Canvas Business Model: Revenue Streams

You're looking at the core engine driving Soleno Therapeutics, Inc.'s current financial picture, which is almost entirely centered on the successful U.S. launch of VYKAT XR for Prader-Willi Syndrome (PWS). The primary, and as of late 2025, sole, revenue stream is the Net product sales of VYKAT XR. For the third quarter ended September 30, 2025, Soleno Therapeutics reported net revenue from VYKAT XR sales of exactly $66.0 million. That figure more than doubled the $32.7 million in total net revenue generated in the second quarter of 2025, which is a defintely strong indicator of market uptake post-FDA approval on March 26, 2025. This revenue stream is entirely derived from Direct sales revenue from the U.S. PWS market, where VYKAT XR is the first and only FDA-approved therapy for hyperphagia in patients 4 years and older.

Here's a quick look at the sales performance and key adoption metrics that underpin that $66.0 million in Q3 2025 revenue:

Beyond the immediate sales, the business model includes provisions for Potential future milestone payments from ex-U.S. licensing deals, though the current financial reporting reflects domestic sales milestones tied to the original Essentialis merger. Soleno Therapeutics carries a liability for contingent consideration payable upon achieving two commercial sales milestones of $100 million and $200 million in cumulative revenue. As of September 30, 2025, the fair value of this liability was estimated at $19.5 million. The total maximum cash payments obligated under this structure is up to $21.2 million, which you should track as a potential future cash outlay, even if the initial trigger events were based on U.S. sales performance.

Looking forward, the revenue potential extends to Future revenue from VYKAT XR in other rare genetic obesities. While no specific financial projections for these indications are public right now, the company's stated belief is that VYKAT XR has the potential to become a foundational therapy. This suggests a pipeline of future revenue streams contingent on successful development and regulatory approvals in adjacent markets. The current cash position of $556.1 million as of the end of Q3 2025, which includes $230 million from a July 2025 stock offering, is intended to fund the ongoing U.S. launch and support these future business activities.

• Primary revenue driver: VYKAT XR net sales in the U.S. PWS market.
• Q3 2025 Net Income: $26.0 million, marking profitability.
• Cash generated from operations in Q3 2025: $43.5 million.
• Contingent consideration liability fair value: $19.5 million as of September 30, 2025.
• Future revenue hinges on expanding indications beyond PWS.