The journey from seed funding to an Initial Public Offering (IPO) for life science companies is particularly intricate due to the unique regulatory, clinical, and market dynamics inherent in the industry.

Navigating the journey from seed funding to IPO successfully requires a strategic approach, a clear understanding of necessary milestones, and the right expertise at each stage. By engaging specialized consultants, building a skilled team, and following a structured roadmap, life science startups can orchestrate a smooth—and profitable—transition.

Position your life sciences organization for IPO success with insights into:

• The stages of growth for life science companies
• Milestones needed for progression
• Consultants required at each phase
• Headcount and skills needed
• A structured roadmap specific to life science organizations.

Understanding the Stages of Growth

Life science companies typically progress through several distinct stages during the IPO transition, each characterized by specific funding sources and focus areas.

Seed Stage

In the seed stage, companies often rely on angel investors, venture capitalists focused on life sciences, and government grants. The primary focus during this phase is on early-stage research, proof of concept, and initial regulatory assessments.

Founders must develop a scientific hypothesis, secure initial funding, and establish a founding team with the necessary scientific expertise.

Additionally, filing for patents to protect intellectual property is crucial at this stage.

Early Stage

As companies transition to the early stage, they seek Series A and B funding rounds and the focus shifts to conducting preclinical studies, initiating clinical trials, and building a strong scientific team.

Completing preclinical studies to demonstrate safety and efficacy is essential, along with initiating Phase I clinical trials and securing Series A funding.

Establishing key performance indicators (KPIs) related to clinical progress and regulatory milestones becomes vital for tracking development.

Growth Stage

In the growth stage, companies typically pursue Series C funding and beyond. The emphasis is on advancing through clinical trial phases, scaling operations, and preparing for commercialization.

Achieving significant milestones, such as successful trial results or regulatory approvals, is critical during this phase. Companies must also build a robust manufacturing and quality assurance framework to support their products as they move toward market readiness.

Pre-IPO Stage

As companies approach the pre-IPO stage, they often secure funding from late-stage venture capital and private equity. The focus shifts to strengthening corporate governance, ensuring compliance with regulatory bodies, and preparing for public scrutiny.

Hiring a Chief Financial Officer (CFO) with IPO experience and implementing strong corporate governance practices are essential steps.

Additionally, companies must prepare financial statements in accordance with GAAP or IFRS and ensure compliance with SEC regulations.

IPO Stage

In the IPO stage, companies turn to public market investors for funding. The primary focus is on launching the IPO, managing investor relations, and sustaining growth post-IPO.

This involves:

• Filing the registration statement with the SEC
• Conducting roadshows to attract institutional investors and analysts
• Successfully launching the IPO to begin trading on a public exchange

Key Milestones for Progression

At each stage of growth, specific milestones must be achieved to proceed to the next phase.

For example:

• Seed Stage. Companies must develop a scientific hypothesis, secure initial funding, and file for necessary patents.
• Early Stage. Completing preclinical studies and initiating Phase I clinical trials are critical milestones.
• Growth Stage. Advancing to Phase II and III clinical trials and achieving significant milestones, such as regulatory approvals, become paramount.
• Pre-IPO Stage. Hiring key executives with IPO experience and preparing financial statements for public scrutiny are essential.
• IPO Stage. Filing with the SEC and conducting roadshows are crucial steps for a successful public offering.

Consultants Needed

Navigating the journey from seed funding to IPO in the life sciences sector requires specialized expertise at each stage of development.

Seed Stage

During the seed stage, companies benefit from the guidance of scientific advisors who provide direction on research and experimental design.

Legal advisors are also crucial, assisting with incorporation, intellectual property matters, and early regulatory considerations.

Early-Stage

As companies enter the early stage, regulatory consultants become essential for navigating the complex regulatory landscape, particularly with agencies like the FDA and EMA. Clinical Research Organizations (CROs) can manage clinical trials logistics, while financial advisors can help with budgeting and fundraising strategies.

Growth Stage

In the growth stage, operations consultants help optimize processes and supply chain management, while quality assurance consultants ensure compliance with Good Manufacturing Practices (GMP).

Market access consultants advise on pricing and reimbursement strategies, positioning products effectively for market entry.

Pre-IPO Stage

As companies prepare for an IPO, investment bankers guide them through the IPO process, while compliance consultants ensure adherence to regulatory requirements.

Corporate governance advisors help establish effective board structures and governance policies, which are critical for building investor confidence.

IPO Stage

During the IPO stage, public relations firms manage media relations and public perception, while investor relations consultants facilitate communication between the company and its investors.

Financial auditors conduct independent audits of financial statements, ensuring accuracy and compliance with reporting standards.

Headcount and Needed Skills

The headcount and skills required evolve as companies progress through each stage.

• Seed Stage: Companies typically start with a small team of two to five members, focusing on research and development, regulatory knowledge, and basic finance.
• Early Stage: As the company grows to 10-20 team members, skills in clinical trial management, regulatory affairs, data analysis, and financial forecasting become essential.
• Growth Stage: In the growth stage, headcount expands to 50-100 members, requiring advanced clinical research, operations management, quality assurance, and strategic planning skills.
• Pre-IPO Stage: Companies preparing for an IPO may have 100-200 team members, necessitating expertise in corporate governance, compliance, investor relations, and advanced financial management.
• IPO Stage: Finally, as companies transition to a public entity, headcount exceeds 200, with a need for skills in public company reporting, investor communications, risk management, and scientific expertise.

Roadmap to a Successful Life Science IPO

To navigate the IPO journey effectively, leverage the following life science-specific roadmap:

Year 1: Seed Stage

• Secure seed funding.
• Conduct preliminary research and file for patents.
• Assemble a founding team with scientific and regulatory expertise.

Year 2: Early Stage

• Complete preclinical studies and secure Series A funding.
• Initiate Phase I clinical trials.
• Establish KPIs and refine business strategy based on trial outcomes.

Year 3: Growth Stage

• Advance to Phase II and III clinical trials.
• Achieve significant milestones, such as successful trial results or regulatory approvals.
• Prepare for Series B funding and build a robust manufacturing framework.

Year 4: Pre-IPO Stage

• Hire key executives (CFO, COO) with IPO experience.
• Implement strong corporate governance and establish an advisory board.
• Prepare financial statements for public scrutiny and ensure compliance with SEC regulations.

Year 5: IPO Stage

• Engage investment bankers and file with the SEC.
• Conduct roadshows and finalize pricing.
• Launch the IPO and transition to a public company.

We’re Here to Help

To learn more on how to position your life science company for a successful IPO journey, contact your Moss Adams professional.

Additional Resources

• Life Sciences Practice
• IPO Solutions Services