Soleno Therapeutics, Inc. (SLNO): Business Model Canvas [11-2024 Updated]

In the rapidly evolving biotech landscape, Soleno Therapeutics, Inc. (SLNO) stands out with its innovative approach to treating rare diseases. This blog post delves into the company's Business Model Canvas, highlighting key aspects such as its strategic partnerships, essential resources, and unique value propositions. Discover how Soleno navigates the complexities of drug development and regulatory compliance to make a significant impact in the healthcare sector.

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

Collaborations with research institutions

Soleno Therapeutics engages in partnerships with various research institutions to advance its clinical programs and enhance its research capabilities. Collaborations with academic and research organizations enable the company to leverage specialized expertise and access to technologies. Notably, these partnerships are crucial for the development of DCCR (Diazoxide Choline) Extended-Release tablets, which target rare diseases such as Prader-Willi syndrome.

Partnerships with regulatory bodies

Soleno Therapeutics maintains active communication and partnerships with regulatory bodies, particularly the FDA. The company has received Fast-Track and Breakthrough Therapy designations for DCCR, highlighting its commitment to expediting the development of treatments for serious conditions. The New Drug Application (NDA) for DCCR was submitted on June 28, 2024, and the FDA granted Priority Review with a target action date set for December 27, 2024.

Relationships with suppliers for clinical trials

To support its clinical trials, Soleno Therapeutics has established relationships with various suppliers, including contract research organizations (CROs) and contract manufacturing organizations (CMOs). These relationships are essential for ensuring the timely execution of clinical studies and the manufacturing of trial materials. As of September 30, 2024, the company had incurred significant expenses related to research and development, totaling $57.1 million for the nine months ended on that date.

Partnership Type	Key Partners	Purpose	Financial Impact
Research Institutions	Various Academic Institutions	Enhance research capabilities and clinical program execution	Supports R&D expenditures of $57.1 million (FY 2024)
Regulatory Bodies	FDA	Facilitate drug approval processes	Potential for expedited market access for DCCR
Clinical Trial Suppliers	CROs and CMOs	Execute clinical trials and manufacture trial materials	Incurred costs of $57.1 million in R&D

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

Research and development of therapeutics

Soleno Therapeutics focuses on the research and development (R&D) of novel therapeutics, particularly targeting rare diseases. For the nine months ended September 30, 2024, the company reported R&D expenses of $57.1 million, a significant increase from $16.5 million in the same period of 2023. This increase includes $23.7 million attributed to non-cash stock-based compensation.

Personnel costs associated with R&D rose by $4.9 million, reflecting the hiring of additional employees to support these activities. Costs related to the New Drug Application (NDA) submission increased by $9.9 million, and $3.7 million was invested in supply chain activities in preparation for a commercial launch.

Clinical trials for drug approval

Clinical trials are a critical component of Soleno's business model as they are essential for obtaining regulatory approval for its therapeutics. The company’s lead candidate, DCCR (Diazoxide Choline) Extended-Release tablets, is undergoing clinical trials for the treatment of Prader-Willi syndrome (PWS). The NDA for DCCR was submitted to the FDA on June 28, 2024, and granted Priority Review with a target action date of December 27, 2024.

As of September 30, 2024, Soleno has incurred substantial costs related to clinical trials, contributing to its total operating expenses of $128.6 million for the nine months ended September 30, 2024, compared to $27.5 million for the same period in 2023.

Regulatory submissions and compliance

Regulatory compliance is vital for Soleno's operations, especially in the pharmaceutical industry. The company has engaged in extensive regulatory submissions, including its recent NDA for DCCR. Compliance with FDA regulations and guidelines is paramount, requiring significant resources and expertise. The costs associated with these regulatory activities increased by $2.7 million in conjunction with the NDA submission.

Soleno's total liabilities as of September 30, 2024, stood at $32.0 million, with an accumulated deficit of $396.3 million, indicating the financial burden associated with ongoing compliance and regulatory processes.

Key Activity	Q3 2024 Expenses	Q3 2023 Expenses	Increase/Decrease
Research and Development	$30.1 million	$6.0 million	$24.1 million increase
General and Administrative	$49.2 million	$3.3 million	$45.9 million increase
Total Operating Expenses	$80.2 million	$10.4 million	$69.8 million increase

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

Intellectual property and patents

As of September 30, 2024, Soleno Therapeutics, Inc. holds various patents related to its therapeutic products. The company's focus is on developing novel therapeutics for rare diseases, particularly those with increased mortality risks and cardiovascular complications. The intellectual property portfolio is critical for protecting its innovations and ensuring competitive advantage in the pharmaceutical market.

Financial resources from equity offerings

In May 2024, Soleno completed a public offering of 3,450,000 shares of common stock at a price of $46.00 per share, generating gross proceeds of approximately $158.7 million, before deducting underwriter discounts and offering expenses of around $9.7 million. Earlier, in October 2023, the company raised $69.0 million from a similar offering at $20.00 per share, alongside a private placement that added $60.0 million. Cumulatively, these actions provided significant capital to support ongoing clinical trials and operational expenses.

As of September 30, 2024, Soleno reported:

Financial Metric	Amount (in millions)
Cash and cash equivalents	$48.4
Marketable securities	$208.4
Long-term marketable securities	$27.9
Working capital	$243.2
Accumulated deficit	$396.3

Experienced management and scientific team

Soleno Therapeutics has assembled a skilled management team with extensive experience in the pharmaceutical industry. The leadership includes individuals with backgrounds in drug development, regulatory affairs, and commercialization strategies. The scientific team is composed of experts in clinical research and product development, essential for navigating the complexities of bringing new therapies to market.

During the nine months ended September 30, 2024, the company reported:

Expense Category	Amount (in millions)
Research and development	$57.1
General and administrative	$68.6
Total operating expenses	$128.6
Net loss	$119.9

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

Innovative therapies for rare diseases

Soleno Therapeutics focuses on developing novel therapeutics specifically targeting rare diseases, with its lead product being DCCR (Diazoxide Choline) Extended-Release tablets, aimed at treating Prader-Willi syndrome (PWS). As of September 30, 2024, the company reported an accumulated deficit of $396.3 million, reflecting its ongoing investment in research and development without current revenue from commercial sales.

Fast-Track and Breakthrough Therapy designations

DCCR has received both Fast-Track and Breakthrough Therapy designations from the FDA, which facilitates the development and expedites the review of drugs intended to treat serious conditions and fill an unmet medical need. The New Drug Application (NDA) for DCCR was submitted on June 28, 2024, and the FDA granted Priority Review status, with a target action date set for December 27, 2024.

Potential for significant market impact

The market for treating rare diseases is substantial. The global rare disease therapeutics market is expected to reach $250 billion by 2024, growing at a CAGR of 12% from 2020 to 2024. Soleno's DCCR, with its unique formulation and targeted application, positions it favorably within this lucrative sector.

Metric	Value
Accumulated Deficit	$396.3 million
Market Potential for Rare Diseases	$250 billion (by 2024)
CAGR of Rare Disease Market (2020-2024)	12%
DCCR Submission Date	June 28, 2024
FDA PDUFA Target Action Date	December 27, 2024

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

Engagement with healthcare professionals

Soleno Therapeutics maintains a strategic focus on building relationships with healthcare professionals (HCPs) to facilitate the adoption of its products. The company conducts outreach initiatives aimed at educating HCPs about its lead candidate, DCCR (Diazoxide Choline), specifically targeting conditions like Prader-Willi syndrome (PWS). As of September 30, 2024, Soleno reported an operating loss of $128.6 million, which reflects substantial investments in marketing and educational activities to engage HCPs effectively.

Support for patients and caregivers

Soleno Therapeutics emphasizes robust support mechanisms for patients and their caregivers. The company provides resources that assist with treatment management, including informational materials and dedicated support teams. As part of its commitment, Soleno has allocated a significant portion of its budget towards general and administrative expenses, which reached $68.6 million for the nine months ended September 30, 2024, indicating a strategic investment in patient support services.

Educational initiatives on rare diseases

Soleno is dedicated to raising awareness about rare diseases through targeted educational initiatives. The company focuses on disseminating information regarding the implications of PWS and the role of DCCR in treatment. This initiative is supported by a budget for research and development amounting to $57.1 million for the nine months ended September 30, 2024, which includes efforts to enhance educational outreach.

Initiative	Details	Financial Impact (2024)
Engagement with HCPs	Outreach initiatives and educational programs for healthcare professionals	$128.6 million operating loss reflecting marketing efforts
Patient Support	Resources and dedicated teams for treatment management	$68.6 million in general and administrative expenses
Educational Initiatives	Awareness programs on rare diseases and treatment options	$57.1 million in research and development expenses

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

Direct sales to healthcare providers

Soleno Therapeutics primarily targets healthcare providers specializing in rare diseases for the direct sale of its lead product, DCCR (Diazoxide Choline Extended-Release tablets). The company has focused its marketing efforts on practitioners who treat Prader-Willi syndrome (PWS), as DCCR is intended for this indication. As of September 30, 2024, Soleno has incurred operating expenses totaling $128.6 million for the nine months ended, with a significant portion allocated to sales and marketing to support this channel.

Collaboration with specialty pharmacies

Collaboration with specialty pharmacies is a critical component of Soleno's distribution strategy. These pharmacies are equipped to handle the unique needs of patients with rare diseases and provide DCCR to patients after a prescription from healthcare providers. As of September 30, 2024, Soleno reported an accumulated deficit of $396.3 million, reflecting the ongoing investment in building these partnerships and ensuring patient access to their therapies.

Metric	Value
Market Size for Rare Diseases	$300 billion
Estimated Patients with PWS in the U.S.	10,000 - 30,000
Projected Revenue for DCCR (if approved)	$100 million annually

Online platforms for information dissemination

Soleno utilizes online platforms to disseminate information about DCCR and its potential benefits for patients with PWS. This includes leveraging digital marketing strategies, educational webinars, and social media outreach to engage both healthcare providers and patients. The company has reported an increase in interest income to approximately $8.7 million for the nine months ended September 30, 2024, which may indicate an effective allocation of resources towards digital engagement strategies.

Online Engagement Metrics	Value
Webinars Conducted	15 in 2024
Social Media Followers	20,000+
Website Traffic Increase	50% YoY

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

Patients with Rare Diseases

Soleno Therapeutics focuses on developing therapeutics for patients with rare diseases, specifically targeting Prader-Willi syndrome (PWS). The company’s lead product, DCCR (Diazoxide Choline), has received Fast-Track and Breakthrough Therapy designations from the FDA. As of September 30, 2024, there are approximately 10,000 individuals diagnosed with PWS in the United States, with a significant unmet medical need for effective treatments.

Healthcare Providers and Institutions

Healthcare providers, including pediatricians, endocrinologists, and geneticists, are critical customer segments for Soleno. These professionals are responsible for diagnosing and managing rare diseases like PWS. In 2024, Soleno aims to establish partnerships with over 200 healthcare institutions across the U.S. to facilitate the distribution and administration of DCCR. The company plans to conduct educational outreach and provide resources to healthcare professionals to enhance understanding of PWS and its treatment.

Investors Seeking Growth in Biotech

Investors represent another key customer segment for Soleno Therapeutics. The company has been actively engaged in public offerings to fund its operations. In May 2024, Soleno closed an underwritten public offering of 3,450,000 shares at a price of $46.00 per share, generating gross proceeds of approximately $158.7 million. As of September 30, 2024, Soleno reported an accumulated deficit of $396.3 million, reflecting its ongoing investment in research and development. The company’s focus on innovative treatments for rare diseases positions it as a compelling opportunity for biotech investors, particularly those interested in high-growth sectors.

Customer Segment	Key Metrics	Strategies
Patients with Rare Diseases	10,000 diagnosed PWS patients in the U.S.	Develop DCCR as a leading treatment option
Healthcare Providers and Institutions	Targeting 200 healthcare institutions by end of 2024	Conduct educational outreach and provide treatment resources
Investors Seeking Growth in Biotech	Raised $158.7 million in May 2024 public offering	Highlight growth potential in rare disease therapeutics

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

High research and development expenses

For the nine months ended September 30, 2024, Soleno Therapeutics incurred $57.1 million in research and development expenses, which includes $23.7 million of non-cash stock-based compensation. This represents a significant increase from $16.5 million in the same period of 2023, which included $1.6 million of non-cash stock-based compensation. Personnel costs rose by $4.9 million due to hiring additional staff to support research activities, and costs associated with the New Drug Application (NDA) submission increased by $9.9 million.

Operational costs for clinical trials

Operating expenses related to clinical trials include both direct costs and indirect costs associated with trial management. For the nine months ended September 30, 2024, total operating expenses amounted to $128.6 million, with research and development expenses making up a significant portion. The operational costs are expected to fluctuate based on the progression of clinical studies and the timing of various projects necessary for NDA submissions.

Administrative expenses related to compliance

Administrative expenses for the nine months ended September 30, 2024, were reported at $68.6 million, which included $46.5 million of non-cash stock-based compensation. This is a dramatic increase from $9.3 million in the same period of 2023. Costs related to personnel, professional services, and compliance have risen, reflecting Soleno’s preparations for product launch and the increased complexity of regulatory compliance.

Expense Category	2024 (Nine Months)	2023 (Nine Months)	Change ($)	Change (%)
Research and Development	$57.1 million	$16.5 million	$40.6 million	246%
General and Administrative	$68.6 million	$9.3 million	$59.3 million	634%
Total Operating Expenses	$128.6 million	$27.5 million	$101.1 million	368%

As of September 30, 2024, Soleno had an accumulated deficit of $396.3 million and net losses of $119.9 million for the nine months. This financial trajectory highlights the significant costs associated with the company’s operations as it strives to bring its lead therapeutic candidate to market while navigating the complexities of clinical trials and regulatory compliance.

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

Future sales of approved therapeutics

As of September 30, 2024, Soleno Therapeutics has not yet generated revenue from the commercial development and sale of novel therapeutic products. The company is in the process of preparing for commercial launch, primarily focusing on its lead product candidate, DCCR (diazoxide choline), which targets the treatment of Prader-Willi Syndrome (PWS). The expected future sales will be contingent upon FDA approval and successful market penetration.

Potential milestone payments from partnerships

Soleno Therapeutics has entered into agreements that may yield milestone payments. Notably, the company is obligated to make cash payments up to a maximum of $21.2 million to former Essentialis stockholders upon achieving certain commercial milestones associated with DCCR sales. The estimated fair value of this contingent consideration was approximately $14.5 million as of September 30, 2024.

These payments are tied to achieving cumulative revenue milestones of $100 million and $200 million in future years.

Interest income from marketable securities

In the nine months ended September 30, 2024, Soleno reported other income of approximately $8.7 million, primarily driven by an increase in interest income from cash, cash equivalents, and marketable securities. This represents a significant increase from other expense of approximately $0.2 million during the same period in 2023.

The company holds $208.4 million in marketable securities and $27.9 million in long-term marketable securities as of September 30, 2024. The interest income is reflective of the rising rates and increased investment in these instruments, indicating a solid revenue stream from interest on marketable securities.

Revenue Stream	Details	Financial Data
Future Sales of Approved Therapeutics	Pending FDA approval for DCCR, targeting Prader-Willi Syndrome.	No revenue generated as of Sept 30, 2024.
Potential Milestone Payments	Cash payments up to $21.2 million tied to commercial milestones.	Estimated fair value of contingent consideration: $14.5 million as of Sept 30, 2024.
Interest Income from Marketable Securities	Income generated from cash and marketable securities.	Other income: $8.7 million for nine months ended Sept 30, 2024.

Updated on 16 Nov 2024

Resources:

1. Soleno Therapeutics, Inc. (SLNO) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Soleno Therapeutics, Inc. (SLNO)' financial performance, including balance sheets, income statements, and cash flow statements.
2. SEC Filings – View Soleno Therapeutics, Inc. (SLNO)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.