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

Explore the innovative landscape of Cidara Therapeutics, Inc. (CDTX) as we delve into its Business Model Canvas. This framework reveals how Cidara navigates the complexities of the biotechnology industry, highlighting key elements such as strategic partnerships, groundbreaking technologies, and diverse revenue streams. Discover how this company positions itself to tackle serious diseases and engage with healthcare systems, paving the way for future success.

Cidara Therapeutics, Inc. (CDTX) - Business Model: Key Partnerships

Collaborations with Janssen Pharmaceuticals

Cidara Therapeutics entered into a significant partnership with Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. On April 24, 2024, Cidara paid an upfront fee of $85.0 million as part of the Janssen License Agreement. This agreement transitioned from an earlier collaboration framework, effectively ending the Janssen Collaboration Agreement that had generated collaboration revenue of $1.3 million for the nine months ended September 30, 2024.

Licensing Agreements for Product Development

Under the terms of the Janssen License Agreement, Cidara has the potential to earn up to $605.0 million in milestone payments related to the development and commercialization of its product CD388. This includes up to $150.0 million in development and regulatory milestone payments and $455.0 million in commercialization milestone payments.

Partnerships with Research Organizations

Cidara has strategically partnered with various research organizations to enhance its R&D capabilities. As of September 30, 2024, the company reported $25.0 million in research and development expenses, which reflects ongoing investments in clinical trials and product development. The collaboration with research entities is crucial for advancing the Cloudbreak platform and its drug-Fc conjugates (DFC).

Strategic Alliances for Funding and Development

Cidara has engaged in several funding strategies, including a recent private placement that raised $240.0 million in April 2024. This funding was pivotal in supporting ongoing trials and development programs. Additionally, the company has initiated collaborations that may provide further funding opportunities through government grants and other third-party funding.

Partnership Type	Partner	Financial Commitment	Potential Milestones
Collaboration	Janssen Pharmaceuticals	$85.0 million (upfront payment)	Up to $605.0 million in milestones
Research Partnership	Various Research Organizations	Included in R&D expenses of $25.0 million	Not specified
Funding	Private Investors	$240.0 million (April 2024)	Support for ongoing trials and development

Cidara Therapeutics, Inc. (CDTX) - Business Model: Key Activities

Conducting clinical trials for product candidates

Cidara Therapeutics is actively engaged in conducting clinical trials for its product candidates, particularly the CD388, which is currently in Phase 2b of the NAVIGATE study. For the nine months ended September 30, 2024, the company reported research and development expenses of $25.0 million, reflecting ongoing clinical activities and associated costs. The company has incurred significant costs associated with these trials, which include an upfront payment of $85.0 million to Janssen as part of their licensing agreement.

Research and development of the Cloudbreak platform

The Cloudbreak platform is central to Cidara's business model, enabling the development of drug-Fc conjugate (DFC) immunotherapies. The company has invested heavily in research and development, totaling $25.0 million for the nine months ended September 30, 2024. This expenditure encompasses both the ongoing development of existing candidates and the exploration of new DFCs. As of September 30, 2024, Cidara had an accumulated deficit of $559.0 million, indicating substantial investment in R&D over the years.

Regulatory submissions and compliance

Cidara is tasked with preparing and submitting regulatory filings to the U.S. Food and Drug Administration (FDA) and other regulatory bodies. The company aims to achieve the necessary approvals for its clinical protocols and product candidates, which is a critical component of its operations. This compliance process is resource-intensive, with expected increases in operating expenses as the company progresses with its regulatory submissions.

Manufacturing and supply chain management

As part of its operational activities, Cidara manages the manufacturing and supply chain for its product candidates, particularly in the context of clinical trials. The company is responsible for ensuring that the production of its DFCs meets regulatory standards and is aligned with clinical trial requirements. As of September 30, 2024, Cidara had cash and cash equivalents of $127.4 million, which it plans to utilize for ongoing manufacturing and operational activities.

Activity	Details	Financial Impact (as of Sept 30, 2024)
Clinical Trials	Conducting Phase 2b NAVIGATE study for CD388	R&D expenses: $25.0 million
Cloudbreak Platform R&D	Development of DFC immunotherapies	Accumulated deficit: $559.0 million
Regulatory Compliance	Submissions to FDA and other authorities	Expected increase in operating expenses
Manufacturing	Production aligned with clinical trial requirements	Cash and cash equivalents: $127.4 million

Cidara Therapeutics, Inc. (CDTX) - Business Model: Key Resources

Proprietary Cloudbreak technology platform

The Cloudbreak platform is pivotal for Cidara Therapeutics, enabling the development of drug-Fc conjugate (DFC) immunotherapies. This innovative approach aims to target specific diseases while engaging the immune system simultaneously. The platform's capacity to facilitate the creation of novel therapeutics positions Cidara uniquely in the biotechnology sector.

Experienced research and development team

Cidara boasts a skilled research and development team dedicated to advancing its product candidates through clinical trials. As of September 30, 2024, the company reported research and development expenses of $25.0 million for the nine months ended, reflecting its commitment to R&D activities despite a strategic workforce reduction of approximately 30% completed by November 1, 2024.

Financial resources from equity and partnerships

In April 2024, Cidara secured substantial financial backing through a private placement, raising $240.0 million from the sale of 240,000 shares of Series A Convertible Voting Preferred Stock at $1,000 per share. The proceeds from this transaction were primarily allocated to fund an upfront payment of $85.0 million to Janssen Pharmaceuticals under a licensing agreement. Additionally, as of September 30, 2024, Cidara had cash and cash equivalents totaling $127.4 million, significantly increasing from $35.8 million at the beginning of the period.

Financial Metric	Value (in thousands)
Cash and Cash Equivalents	$127,386
Private Placement Proceeds	$240,000
Upfront Payment to Janssen	$85,000
R&D Expenses (9 months)	$25,005

Intellectual property portfolio

Cidara's intellectual property portfolio is crucial for its competitive advantage, encompassing patents and rights associated with its Cloudbreak technology and DFC candidates. The company has made significant investments in maintaining and expanding this portfolio, vital for protecting its innovations and ensuring future revenue streams. As of September 30, 2024, Cidara had an accumulated deficit of $559.0 million, indicating the substantial investments made in R&D and IP development over time.

Cidara Therapeutics, Inc. (CDTX) - Business Model: Value Propositions

Innovative DFCs targeting serious diseases

Cidara Therapeutics leverages its proprietary Cloudbreak platform to develop drug-Fc conjugates (DFCs) aimed at serious diseases. The company is focused on CD388, designed for the prevention and treatment of influenza. CD388 has completed Phase 1 and Phase 2a clinical trials and is currently advancing through further stages of development under a collaboration with Janssen Pharmaceuticals.

Potential for universal prevention and treatment of influenza

CD388 is particularly notable for its potential to provide universal prevention and treatment against seasonal and pandemic influenza. This unique capability positions Cidara amidst increasing global concerns regarding influenza outbreaks. As of September 30, 2024, the company had an accumulated deficit of approximately $559 million, indicating significant investments in R&D to support this goal.

Long-acting therapies with dual action mechanisms

The DFCs developed by Cidara are designed to provide long-acting therapies that engage the immune system while targeting specific disease pathways. This dual-action mechanism aims to enhance efficacy and prolong therapeutic effects, potentially reducing the frequency of administration required by patients.

Unique approach to engage the immune system

Cidara’s Cloudbreak platform facilitates the development of therapies that not only inhibit disease targets but also actively engage the immune response. This innovative approach is expected to improve patient outcomes significantly. The total revenue from collaboration agreements in the fiscal year 2024 reached approximately $1.3 million, reflecting the early-stage commercial potential of these therapies.

Value Proposition	Description	Financial Impact
Innovative DFCs	Targeting serious diseases using Cloudbreak platform	Investment in R&D leading to Phase 1 and Phase 2a completion
Universal Influenza Treatment	Potential for comprehensive prevention and treatment	Accumulated deficit of $559 million indicates investment scale
Long-acting Therapies	Designed for dual mechanisms of action	Revenue from collaboration agreements approximately $1.3 million
Immune System Engagement	Innovative approach to enhance therapeutic efficacy	Strategic collaborations with Janssen and others for funding

Cidara Therapeutics, Inc. (CDTX) - Business Model: Customer Relationships

Building relationships with healthcare providers

Cidara Therapeutics engages with healthcare providers primarily through collaborations and partnerships aimed at developing and commercializing its product candidates. The company's focus on serious diseases necessitates robust relationships with key opinion leaders (KOLs) and healthcare professionals who influence treatment protocols. For instance, the Phase 2b NAVIGATE study of its influenza product candidate CD388 involves direct interactions with clinical trial sites and investigators, ensuring that providers are well-informed about the product's benefits and applications.

Engaging with regulatory agencies for approvals

Cidara Therapeutics actively engages with regulatory agencies, including the U.S. Food and Drug Administration (FDA), to secure approvals for its drug candidates. This engagement is critical, especially as the company prepares to submit investigational new drug applications (INDs) for CD388 and other products. For example, the upfront payment of $85.0 million to Janssen under the Janssen License Agreement on April 24, 2024, highlights the strategic investment in advancing regulatory approvals and the importance of maintaining transparent communication with regulatory bodies.

Collaborating with partners for joint development

Strategic collaborations are a cornerstone of Cidara's business model. The company entered into a license and collaboration agreement with Janssen Pharmaceuticals, which allows for joint development efforts on drug candidates derived from its Cloudbreak platform. The financial commitment includes potential milestone payments of up to $150.0 million for development and regulatory milestones, as well as up to $455.0 million for commercialization milestones. Such partnerships not only enhance research capabilities but also expand market access upon product approval.

Providing updates and transparency to investors

Cidara Therapeutics prioritizes investor relations by providing regular updates on clinical trial progress, financial performance, and strategic direction. The company reported a net loss of $117.5 million for the nine months ended September 30, 2024, compared to a loss of $19.7 million for the same period in 2023. This transparency is crucial in maintaining investor confidence, especially given the company's reliance on equity financing for operational sustainability. As of September 30, 2024, Cidara had cash and cash equivalents totaling $127.4 million, which is expected to support its operations through mid-2025.

Aspect	Details
Upfront Payment to Janssen	$85.0 million
Potential Development Milestones	Up to $150.0 million
Potential Commercialization Milestones	Up to $455.0 million
Net Loss (9 months ended September 30, 2024)	$117.5 million
Cash and Cash Equivalents (as of September 30, 2024)	$127.4 million

Cidara Therapeutics, Inc. (CDTX) - Business Model: Channels

Direct engagement with healthcare professionals

Cidara Therapeutics engages directly with healthcare professionals through educational initiatives and clinical presentations. This engagement is crucial for promoting their product candidates and fostering relationships within the medical community. The company’s primary product candidate, CD388, is designed for the prevention and treatment of influenza, and it relies on healthcare professionals for its adoption and use.

Partnerships for distribution of approved products

In April 2024, Cidara entered into a license and technology transfer agreement with Janssen Pharmaceuticals, which included an upfront payment of $85 million. This partnership is expected to facilitate the distribution of CD388 upon approval, leveraging Janssen's extensive distribution network.

Clinical trial sites for patient recruitment

Cidara’s clinical trials, including the ongoing CD388 Phase 2b NAVIGATE study, are critical for patient recruitment. As of September 30, 2024, the company had prepayments and deposits amounting to $27.2 million to a contract research organization to support these trials. These sites are vital for gathering data and ensuring the successful progression of their clinical programs.

Investor relations for funding and support

Cidara has actively engaged in investor relations to secure funding. In the nine months ended September 30, 2024, the company generated $238.9 million from financing activities, primarily through the sale of 240,000 shares of Series A Convertible Voting Preferred Stock. This funding is essential for ongoing research and development efforts, particularly in advancing their product candidates.

Channel	Description	Financial Impact
Direct Engagement	Educational initiatives targeting healthcare professionals.	Supports product adoption and usage.
Partnerships	Distribution agreement with Janssen Pharmaceuticals.	Upfront payment of $85 million; potential for additional milestone payments.
Clinical Trials	Patient recruitment through clinical trial sites.	Prepayments of $27.2 million for research support.
Investor Relations	Engagement with investors for funding support.	Raised $238.9 million in financing activities.

Cidara Therapeutics, Inc. (CDTX) - Business Model: Customer Segments

Hospitals and healthcare systems

Cidara Therapeutics targets hospitals and healthcare systems as key customer segments, particularly for its drug-Fc conjugate (DFC) immunotherapies. The company’s most notable product, REZZAYO® (rezafungin for injection), is utilized in the treatment of candidemia and invasive candidiasis. As of September 30, 2024, Cidara reported a strategic shift in operations with the sale of its rezafungin assets, indicating a focus on new therapeutic areas and innovative treatments.

Pharmaceutical partners and collaborators

Cidara actively collaborates with pharmaceutical partners to enhance its product development pipeline. A significant partnership was established with Janssen Pharmaceuticals, which provided an upfront payment of $85.0 million for the rights to develop CD388, a product candidate aimed at influenza prevention and treatment. The agreement also includes potential milestone payments of up to $150.0 million for development and regulatory achievements and up to $455.0 million in commercialization milestone payments.

Regulatory bodies for drug approvals

Regulatory bodies play a critical role in Cidara's business model, as the company must secure approvals for its products before commercialization. Cidara has submitted investigational new drug applications (INDs) to the U.S. Food and Drug Administration (FDA) and anticipates continued expenditure on regulatory submissions as it advances its clinical development programs.

Investors and stakeholders in biotechnology

Cidara Therapeutics relies on investors and stakeholders for funding its operations and development programs. As of September 30, 2024, the company had cash and cash equivalents amounting to $127.4 million, which it expects will support operations into the fourth quarter of 2025. The company has raised significant capital through various equity offerings, including a private placement that generated $240.0 million.

Customer Segment	Key Focus	Recent Financial Data	Partnerships/Collaborations
Hospitals and healthcare systems	Treatment of candidemia and invasive candidiasis	Revenue from REZZAYO® (rezafungin) assets sold in 2024	Partnership with Mundipharma for asset distribution
Pharmaceutical partners and collaborators	Development of antiviral therapies	Upfront payment of $85.0 million from Janssen	Janssen Pharmaceuticals
Regulatory bodies for drug approvals	Approval of clinical trials and INDs	Ongoing regulatory submissions	FDA and global regulatory agencies
Investors and stakeholders in biotechnology	Funding for R&D activities	Cash and cash equivalents: $127.4 million as of September 30, 2024	Multiple equity financing rounds

Cidara Therapeutics, Inc. (CDTX) - Business Model: Cost Structure

Significant R&D expenses for clinical trials

For the nine months ended September 30, 2024, Cidara Therapeutics incurred $25.0 million in research and development (R&D) expenses, a decrease from $28.8 million for the same period in 2023. The decline was primarily attributed to lower nonclinical expenses associated with their Cloudbreak platform, despite increased costs related to the CD388 Phase 2b NAVIGATE study and personnel costs, including $1.2 million for severance and employee benefits due to a reduction in force.

Manufacturing and operational costs

Cidara's operational costs are significantly influenced by manufacturing activities. As of September 30, 2024, the company had total undiscounted finance lease payments of $0.7 million for lab equipment, which is expected to expire in January 2027. Additionally, total undiscounted operating lease payments amounted to $3.8 million. The company also plans to continue funding its losses through cash on hand and financing activities.

Marketing and sales expenses post-approval

Marketing and sales expenses are anticipated to rise significantly following the approval of product candidates. Cidara has not yet generated significant revenue from product sales, but they expect to establish a sales, marketing, and distribution infrastructure for any products that receive marketing approval. The selling, general, and administrative (SG&A) expenses were reported at $13.3 million for the nine months ended September 30, 2024, an increase from $10.1 million in the same period of 2023.

Administrative and compliance costs

Administrative costs have been rising, with SG&A expenses showing a notable increase due to higher audit fees, legal costs, and personnel expenses. For the three months ended September 30, 2024, SG&A expenses were $5.0 million, compared to $3.3 million for the same period in 2023. The company is also mindful of compliance costs associated with ongoing regulatory requirements and the need for maintaining their intellectual property portfolio.

Cost Category	2024 Expenses (in millions)	2023 Expenses (in millions)	Notes
R&D Expenses	$25.0	$28.8	Decrease due to lower nonclinical expenses
SG&A Expenses	$13.3	$10.1	Increase due to audit fees and legal costs
Finance Lease Payments	$0.7	N/A	Lab equipment lease expiring January 2027
Operating Lease Payments	$3.8	N/A	Lease payments through December 2026

Cidara Therapeutics, Inc. (CDTX) - Business Model: Revenue Streams

Milestone payments from partnerships

Cidara Therapeutics has engaged in various partnerships, notably with Janssen Pharmaceuticals and Melinta Therapeutics. In March 2023, Cidara received a milestone payment of $20.0 million under the Melinta License Agreement upon achieving specific performance obligations. Additionally, as of September 30, 2024, the company recorded collaboration revenue of $1.3 million associated with the Janssen collaboration.

Potential product sales upon approval

While Cidara has not yet commercialized products, they anticipate revenues from potential product sales upon regulatory approval. As of September 30, 2024, Cidara's cash and cash equivalents stood at $127.4 million, which they expect will support operations through the middle of the fourth quarter of 2025. The company aims to transition to generating product revenue from its drug candidates, particularly CD388, if approved.

Licensing fees from collaborations

Cidara has entered into licensing agreements that could generate future revenues through licensing fees. The company capitalized $2.0 million upon execution of the Melinta License Agreement. Moreover, they recognized royalty revenue of $0.1 million during the nine months ended September 30, 2024, following the commercial launch of REZZAYO.

Government and third-party funding for R&D initiatives

Cidara Therapeutics actively seeks government and third-party funding to support its research and development initiatives. As of September 30, 2024, they had amassed an accumulated deficit of $559.0 million. To sustain their operations, they rely on a combination of equity, debt financing, and grants. The company also anticipates that any revenue generated will fluctuate based on the timing of their clinical and regulatory milestones.

Revenue Stream	Details	Financial Impact
Milestone Payments	Partnership with Melinta; $20.0 million milestone payment achieved in March 2023	$20.0 million
Potential Product Sales	Pending approval of drug candidates like CD388	Forecasted revenue from product sales (not yet realized)
Licensing Fees	Licensing agreement with Melinta; $2.0 million capitalized fees	Future royalty revenue expected
Government Funding	Seeking grants and contracts for R&D	Supports ongoing operational costs
Cash Position	Cash and cash equivalents as of Sept 30, 2024	$127.4 million

Updated on 16 Nov 2024

Resources:

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