Athira Pharma, Inc. (ATHA): Business Model Canvas [11-2024 Updated]

In the rapidly evolving biotech landscape, Athira Pharma, Inc. (ATHA) stands out with its innovative approach to tackling neurodegenerative diseases like ALS and Alzheimer's. With a robust business model canvas that emphasizes strategic partnerships, cutting-edge research, and a commitment to patient care, Athira is well-positioned to make a significant impact in the pharmaceutical industry. Discover how this company navigates its key activities, resources, and value propositions to drive growth and address critical healthcare needs.

Athira Pharma, Inc. (ATHA) - Business Model: Key Partnerships

Collaborations with contract research organizations (CROs)

Athira Pharma collaborates with various contract research organizations to conduct preclinical studies and clinical trials for its drug candidates. The company has not disclosed specific CROs but relies on these partnerships to leverage their expertise and infrastructure.

Partnerships with pharmaceutical companies for commercialization

As of 2024, Athira Pharma is exploring collaborations with pharmaceutical companies to enhance its commercial capabilities. The company has not yet established a commercial organization or distribution capabilities but intends to build a commercial infrastructure to support future sales through internal resources and third-party relationships.

Licensing agreements for drug candidates

Athira has a significant licensing agreement with Washington State University (WSU). Under this agreement, Athira holds exclusive rights to certain licensed patents. The company is obligated to meet specific development milestones and pay royalties based on net sales. The key financial terms include:

Milestone Event	Payment Amount
Initiation of Phase 3 trial	$300,000
Receipt of marketing approval	$600,000
Annual minimum royalty payment	$25,000

Relationships with regulatory authorities for approvals

Athira Pharma engages with regulatory authorities such as the FDA to secure approvals for its drug candidates. This relationship is crucial for advancing its clinical trials and ensuring compliance with regulatory standards.

Strategic collaborations for funding and resource sharing

Since inception, Athira has raised approximately $407.4 million through the sale of equity securities, convertible preferred stock, and convertible notes. They have a sales agreement with Cantor Fitzgerald & Co. and BTIG, LLC for an at-the-market equity offering facility, allowing them to raise up to $75 million. As of September 30, 2024, Athira's cash, cash equivalents, and investments totaled $68.9 million.

Athira Pharma, Inc. (ATHA) - Business Model: Key Activities

Conducting clinical trials for ATH-1105

Athira Pharma is currently engaged in clinical trials for ATH-1105, a small molecule therapeutic intended to restore neuronal health. The Phase 1 clinical trial for ATH-1105 commenced in the second quarter of 2024, with associated costs amounting to approximately $2.4 million. The overall research and development expenses for the nine months ended September 30, 2024, totaled $61.3 million, reflecting a focus on advancing clinical trials.

Research and development of small molecule therapeutics

The company has allocated significant resources to research and development, with total expenditures reaching $61.3 million for the first nine months of 2024, a decrease from $70.1 million in the same period of 2023. The direct costs associated with the ATH-1105 program specifically accounted for approximately $6.8 million. This focus on small molecule therapeutics is critical as it aligns with Athira's mission to combat neurodegenerative diseases.

Regulatory submissions for marketing approvals

Athira is actively preparing for regulatory submissions related to its product candidates. The company plans to seek marketing approvals following successful clinical trials, which necessitates comprehensive data collection and documentation. The estimated cash balance of $68.9 million as of September 30, 2024, is intended to support these regulatory activities over the next 12 months.

Building relationships with potential commercial partners

To enhance its commercial capabilities, Athira is focused on establishing partnerships with pharmaceutical companies. The company has not yet developed a commercial organization for distribution but anticipates managing sales and marketing through collaborations. Potential strategic transactions could include licensing agreements that would allow for shared resources and reduced financial burdens during the commercialization phase.

Manufacturing and supply chain management

Athira's operational framework includes establishing a robust manufacturing and supply chain management system to support its clinical programs. The company has incurred significant manufacturing costs, notably a decrease in contract manufacturing expenses related to its previous program, fosgonimeton, which dropped by $5.5 million due to a shift in focus. As of September 30, 2024, the company had cash and cash equivalents sufficient to fund its manufacturing activities, projected at approximately $68.9 million.

Key Activity	Details	Costs (2024)
Clinical Trials for ATH-1105	Phase 1 trial commenced in Q2 2024	$2.4 million
Research and Development	Total R&D expenses for 2024	$61.3 million
Regulatory Submissions	Preparing for marketing approvals	Included in R&D expenses
Commercial Partnerships	Focus on building relationships	N/A
Manufacturing	Establishing supply chain management	Includes R&D and operational costs

Athira Pharma, Inc. (ATHA) - Business Model: Key Resources

Intellectual property portfolio for drug candidates

Athira Pharma has developed a robust intellectual property portfolio essential for its drug candidates. This includes patents related to its lead drug candidates, particularly ATH-1105, which targets neurodegenerative conditions. The company has invested significantly in maintaining and expanding this portfolio to protect its innovations and secure competitive advantages in the biopharmaceutical market.

Cash reserves of $68.9 million as of September 30, 2024

As of September 30, 2024, Athira Pharma reported cash, cash equivalents, and investments totaling $68.9 million. This amount is projected to be sufficient to fund its operating expenses and capital expenditure requirements through at least the next 12 months.

Experienced research and development team

Athira Pharma boasts an experienced research and development team, integral to its operations. The team is focused on advancing the clinical development of its drug candidates, particularly in the areas of neurodegenerative diseases. The company's R&D expenses for the nine months ended September 30, 2024, were approximately $61.3 million, reflecting its commitment to developing innovative therapeutics.

Contract manufacturing organizations (CMOs) for production

Athira Pharma collaborates with contract manufacturing organizations (CMOs) to produce its drug candidates. This strategic partnership allows the company to scale production capabilities efficiently while managing costs. The use of CMOs is crucial in ensuring that Athira can meet the manufacturing demands of its clinical trials and future product commercialization efforts.

Clinical trial data and regulatory compliance infrastructure

The company has established a robust infrastructure for clinical trial data management and regulatory compliance. This infrastructure supports the execution of clinical trials and the submission of regulatory applications. For the nine months ended September 30, 2024, Athira incurred total operating expenses of $85.3 million, which included significant investments in clinical trials.

Key Resource	Details
Intellectual Property Portfolio	Patents for ATH-1105 and other drug candidates
Cash Reserves	$68.9 million as of September 30, 2024
R&D Team	Experienced team driving drug development; R&D expenses of $61.3 million for 2024
Contract Manufacturing	Partnerships with CMOs for efficient production
Clinical Trial Management	Established infrastructure for clinical trials and regulatory compliance

Athira Pharma, Inc. (ATHA) - Business Model: Value Propositions

Development of novel therapies for neurodegenerative diseases

Athira Pharma focuses on developing small molecule therapies aimed at treating neurodegenerative diseases, particularly Alzheimer's disease and amyotrophic lateral sclerosis (ALS). The company's leading drug candidate, ATH-1105, is designed to enhance neuronal health and function.

Potential to restore neuronal health and slow disease progression

Athira's therapies aim to restore neuronal health through innovative mechanisms. For instance, ATH-1105 targets the hepatocyte growth factor (HGF) pathway, crucial for neuronal repair and regeneration. This approach has the potential to slow disease progression in patients suffering from conditions such as Alzheimer's and ALS, addressing significant gaps in current treatment options.

Focus on safety and efficacy in clinical trials

In its clinical trials, Athira prioritizes safety and efficacy, with a robust focus on comprehensive assessment protocols. The company reported a decrease in research and development expenses from $70.1 million in the nine months ended September 30, 2023, to $61.3 million in the same period for 2024, reflecting a strategic shift towards more focused clinical development.

Addressing unmet medical needs in ALS and Alzheimer's disease

Athira Pharma aims to tackle unmet medical needs within the neurodegenerative disease market, which is traditionally underserved. The company has raised approximately $407.4 million since its inception to support its clinical programs. The ongoing development of therapies such as ATH-1105 is positioned to meet critical patient needs where existing treatments fall short.

Innovative approach targeting the neurotrophic HGF system

Athira's unique approach revolves around targeting the neurotrophic HGF system, which has shown promise in preclinical studies. The company’s net loss for the nine months ended September 30, 2024, was $81.9 million, indicating significant investment in its innovative research initiatives. The focus on HGF pathways is anticipated to differentiate Athira's offerings from competitors, providing a distinct value proposition within the pharmaceutical landscape.

Key Metrics	2024 (as of September 30)	2023 (as of September 30)
Net Loss	$81.9 million	$90.4 million
Research and Development Expenses	$61.3 million	$70.1 million
Cash, Cash Equivalents, and Investments	$68.9 million	$154.7 million
Aggregate Net Cash Proceeds Raised	$407.4 million	Not applicable

Athira Pharma, Inc. (ATHA) - Business Model: Customer Relationships

Engagement with healthcare providers for education on therapies

Athira Pharma actively engages healthcare providers to educate them on its drug candidates, particularly focusing on therapies aimed at neurodegenerative diseases. As of September 30, 2024, the company has invested significantly in educational initiatives, with research and development expenses totaling $61.3 million for the nine months ended September 30, 2024. This engagement strategy is crucial for building trust and ensuring that healthcare providers are well-informed about the potential benefits and administration of Athira's therapies.

Patient support programs for drug candidates

The company is developing patient support programs aimed at assisting individuals participating in clinical trials and those who may eventually use its therapies. These programs are designed to enhance patient adherence and provide vital information regarding treatment protocols. As of September 30, 2024, Athira has not yet generated revenue from sales but recognizes the importance of such programs in ensuring positive patient outcomes and satisfaction.

Building relationships with third-party payors for reimbursement

Athira Pharma is in the process of establishing relationships with third-party payors to facilitate reimbursement for its therapies once they receive regulatory approval. The company understands that securing favorable reimbursement terms is essential for market access. As part of its strategy, Athira is preparing to demonstrate the cost-effectiveness and clinical benefits of its drug candidates to payors.

Communication with investors and stakeholders about progress

Effective communication with investors and stakeholders is a priority for Athira Pharma. The company regularly updates its stakeholders on clinical trial progress, financial performance, and strategic initiatives. For instance, Athira reported a net loss of $81.9 million for the nine months ended September 30, 2024, reflecting its ongoing investments in research and development. Maintaining transparency helps to build trust and sustain investor interest in the company’s future prospects.

Transparency in clinical trial results and company developments

Athira Pharma emphasizes transparency in reporting clinical trial results and other significant developments. This approach is vital for maintaining credibility with both the medical community and investors. The company has committed to sharing comprehensive data regarding its clinical trials, including both positive and negative outcomes, which is essential for informed decision-making by healthcare providers and stakeholders alike.

Metric	Value (as of September 30, 2024)
Net Loss	$81.9 million
Research and Development Expenses	$61.3 million
Cash, Cash Equivalents, and Investments	$68.9 million
Accumulated Deficit	$391.1 million

Through these strategies, Athira Pharma aims to establish a strong foundation for customer relationships, ensuring that it can effectively support its therapies and maintain a sustainable business model in the competitive biopharmaceutical market.

Athira Pharma, Inc. (ATHA) - Business Model: Channels

Clinical trial sites for patient recruitment and data collection

Athira Pharma engages clinical trial sites as a primary channel for patient recruitment and data collection. As of September 30, 2024, the company reported significant expenditures in research and development, totaling approximately $61.3 million for the nine months ended September 30, 2024, which reflects their commitment to advancing clinical trials.

Direct outreach to healthcare professionals and institutions

The company employs direct outreach strategies targeting healthcare professionals and institutions. This includes presentations at medical conferences and direct communications to educate and inform about their drug candidates. The total general and administrative expenses related to these activities were approximately $19.9 million for the nine months ended September 30, 2024.

Public relations and investor relations activities

Athira Pharma actively engages in public relations and investor relations activities. In the nine months ending September 30, 2024, they incurred legal expenses of $4.1 million, highlighting their focus on transparency and communication, particularly in light of ongoing litigation and regulatory scrutiny.

Online platforms for information dissemination

To disseminate information effectively, Athira utilizes online platforms including their corporate website and social media channels. This digital presence supports their efforts in engaging with stakeholders and potential investors, contributing to their total cash, cash equivalents, and investments of $68.9 million as of September 30, 2024.

Partnerships with pharmaceutical companies for distribution

Athira Pharma has expressed intentions to build commercial infrastructure through partnerships with established pharmaceutical companies for distribution. While they have not yet generated revenue from drug sales, they have raised approximately $407.4 million through equity and convertible securities, positioning themselves for potential collaborations in the future.

Channel	Details	Financial Impact
Clinical Trial Sites	Patient recruitment and data collection	$61.3 million R&D expenses (9M 2024)
Direct Outreach	Engagement with healthcare professionals	$19.9 million G&A expenses (9M 2024)
Public Relations	Investor communication and legal transparency	$4.1 million legal expenses (9M 2024)
Online Platforms	Corporate website and social media	$68.9 million cash reserves (as of Sep 2024)
Partnerships	Collaboration with pharmaceutical companies	$407.4 million raised through equity financing

Athira Pharma, Inc. (ATHA) - Business Model: Customer Segments

Patients suffering from ALS and Alzheimer's disease

Athira Pharma is primarily focused on developing treatments for neurodegenerative diseases, notably ALS (Amyotrophic Lateral Sclerosis) and Alzheimer's disease. The patient population for ALS is estimated to be approximately 20,000 to 30,000 individuals in the U.S. alone, with about 5,000 new cases diagnosed each year . For Alzheimer's disease, there are over 6 million diagnosed cases in the U.S., with projections indicating that this number could rise to nearly 14 million by 2060 . The market for neurodegenerative disease treatments is projected to reach $35 billion by 2027 .

Healthcare providers and medical professionals

The target customer segment includes healthcare providers such as neurologists, geriatricians, and primary care physicians who are involved in diagnosing and treating ALS and Alzheimer's patients. This segment is critical for the distribution and administration of Athira's drug candidates, particularly ATH-1105, currently under clinical development .

Pharmaceutical companies for potential collaborations

Athira Pharma aims to establish collaborations with other pharmaceutical companies to enhance its capabilities in drug development and commercialization. The company has raised approximately $407.4 million since its inception through equity financing, which could facilitate partnership opportunities with larger pharmaceutical entities .

As of September 30, 2024, Athira has not yet generated revenue from product sales, thus highlighting the importance of partnerships to leverage existing resources and capabilities .

Investors seeking opportunities in biotech

Athira Pharma has attracted interest from institutional and retail investors within the biotech sector. As of September 30, 2024, the company had a market capitalization of approximately $154 million . The company is listed on the NASDAQ under the ticker ATHA, providing a platform for investors who are keen on supporting innovative biopharmaceutical developments targeting significant unmet medical needs .

Regulatory authorities for compliance and approvals

Regulatory authorities such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency) represent a crucial customer segment for Athira Pharma. The company must comply with stringent regulatory requirements to gain approval for its drug candidates . Athira is currently in the process of advancing ATH-1105 through clinical trials, and successful navigation of the regulatory landscape is essential for the potential commercialization of its products .

Customer Segment	Details	Market Size/Population
Patients (ALS)	20,000 - 30,000 diagnosed in the U.S.	5,000 new cases annually
Patients (Alzheimer's)	Over 6 million diagnosed in the U.S.	Projected to reach 14 million by 2060
Healthcare Providers	Neurologists, geriatricians, primary care physicians	Critical for drug distribution
Pharmaceutical Companies	Potential collaborations for drug development	Aggregate funding of $407.4 million since inception
Investors	Institutional and retail investors	Market cap of approximately $154 million as of September 30, 2024
Regulatory Authorities	FDA and EMA compliance	Essential for drug approvals

Athira Pharma, Inc. (ATHA) - Business Model: Cost Structure

High research and development costs for clinical trials

Athira Pharma, Inc. has incurred significant research and development expenses, particularly in clinical trials. For the nine months ended September 30, 2024, the company reported research and development expenses of $61.3 million, down from $70.1 million in the same period in 2023. The decrease was primarily attributed to reductions in costs associated with the fosgonimeton program, which accounted for $37.6 million of the total R&D expenses.

General and administrative expenses for operations

General and administrative expenses also saw a decline, totaling $19.9 million for the nine months ending September 30, 2024, compared to $26.3 million in the prior year. This reduction was largely due to decreased expenses in business development, general corporate expenses, and professional services.

Manufacturing costs through third-party CMOs

Athira Pharma utilizes third-party contract manufacturing organizations (CMOs) for its production needs. For the nine months ended September 30, 2024, the company reported a notable decrease in contract manufacturing costs, contributing to the overall reduction in R&D expenses.

Legal and compliance costs related to regulatory submissions

The company faced legal expenses of $4.1 million related to ongoing investigations during the nine months ending September 30, 2024. This added a significant burden to the overall cost structure, highlighting the financial impact of regulatory compliance.

Marketing and potential commercialization expenses

As of now, Athira does not have a commercial infrastructure in place, which means it has not incurred substantial marketing expenses. However, the company plans to build a commercial organization to support future sales once its drug candidates receive regulatory approval.

Cost Category	Q3 2024 Amount (in millions)	Q3 2023 Amount (in millions)	Change (in millions)	Percentage Change
Research and Development	61.3	70.1	-8.8	-13%
General and Administrative	19.9	26.3	-6.4	-24%
Legal Expenses	4.1	0.0	4.1	N/A
Manufacturing Costs	Decreased (specific amount not disclosed)	Not specified	Not specified	Not specified

Athira Pharma, Inc. (ATHA) - Business Model: Revenue Streams

Future sales of approved drug products

Athira Pharma has not yet generated any revenue from drug product sales as of September 30, 2024. The company is in clinical stages with its drug candidates and has not established a commercial organization or distribution capabilities. Future sales will depend on successful clinical trials and regulatory approvals.

Potential licensing fees from partnerships

Athira has not disclosed specific licensing agreements that may lead to direct revenue. However, the company may pursue licensing arrangements as a strategy for future revenue generation. The potential for income from licensing agreements depends on successful negotiations with pharmaceutical partners and the achievement of specific milestones.

Grants and research funding from governmental bodies

Athira Pharma has recognized aggregate grant income of $15.2 million related to an NIH grant. However, no additional grant income is expected following the nine months ended September 30, 2024. The company will not recognize further grant income in the future as the total approved grant amount has been reached.

Equity financing through stock offerings

From its inception to September 30, 2024, Athira has raised approximately $407.4 million primarily through the issuance of common stock, convertible preferred stock, common stock warrants, and convertible notes. The company has a sales agreement for an “at the market” equity offering facility, allowing it to offer and sell shares of common stock up to an aggregate amount of $75 million.

Collaboration agreements with pharmaceutical companies

Athira has indicated potential collaboration agreements with pharmaceutical companies to enhance its commercial capabilities. The financial terms of any such collaborations could include milestone payments, royalties, and other forms of income. The company has not yet established a clear revenue stream from collaboration agreements as it continues to focus on drug development and clinical trials.

Revenue Source	Details	Financial Impact (as of September 30, 2024)
Future Drug Sales	Pending regulatory approval and commercialization	$0
Licensing Fees	Potential from future partnerships	Not disclosed
Grants	NIH grant income	$15.2 million (cumulative)
Equity Financing	Common stock and convertible securities	$407.4 million raised
Collaboration Agreements	Potential income from pharmaceutical collaborations	Not established

Updated on 16 Nov 2024

Resources:

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