April 15, 2026

Who Typically Writes a Biotech’s Form S-1, What Does it Contain, And What is the Process for Filing it with the SEC?

The Securities and Exchange Commission’s (SEC’s) Form S-1 is the primary registration statement that U.S.-based companies must file with the commission before offering new securities to the public – usually via an IPO on either Nasdaq or the New York Stock Exchange.

For more information see our blog “Understanding Public Biotechs’ Most Common SEC Filings – Part 1 (Forms S-1, S-3, S-8, 8-K, 10-Q and 10-K).”

What is Form S-1?

S-1s are meant to be comprehensive documents containing the information/answers to any and all questions that would-be IPO investors might have about a prospective public offering. In theory, they tell investors all they need to know about a private company to decide if they want to invest. Moreover, an S-1 is considered by the SEC to be the only document investors should use for that purpose.

They are telephone directory-sized documents (or at least they were when such filings were printed and distributed), which can seem unwieldly at best and daunting at worst.

When you break them down, however, they are formulaic, with numerous stakeholders all coming together to contribute to their creation. It’s a heavy lift, but the good news is every public company typically only has to go through the process once.

The life cycle of an S-1.

The life cycle of a Form S-1 includes several key stages.

Stage	Description
1	Drafting the “Business section” of your S-1.
2	Holding your Organizational Meeting (which includes scheduling the first of many S-1 drafting sessions).
3	The detailed preparation (writing/compiling) of your S-1.
4	A confidential or public filing with the SEC  – usually a confidential filing these days
5	A review process by and with the SEC with comments and revisions to your Form S-1. This step can happen multiple times.
6	Marketing to prospective investors via Testing-The-Waters (TTW) meetings.
7	The SEC declaring your S-1 effective (i.e., effectively “approving” your Form S-1, but to be clear, offering no recommendation on the underlying securities themselves).
8	If originally filed confidentially, the public flip of the S-1, making it available for all potential investors to review.
9	The public sale and trading of your securities (formal roadshow, pricing of the issue, etc.).

Source: New Street Investor Relations

Next, let’s break down who typically provides the first draft of an S-1’s various sections.

Breaking down a typical S-1.

#	Section of Form S-1	Who Writes the First Draft?
1	Prospectus Summary	Bankers (usually done last)
2	Risk Factors	Outside Counsel
3	Special Note Regarding Forward-Looking Statements	Outside Counsel
4	Use of Proceeds	Management
5	Dividend Policy	Auditors
6	Capitalization	Auditors
7	Dilution	Auditors
8	Selected Consolidated Financial Data	Auditors
9	Management’s Discussion and Analysis of Financial Condition and Results of Operations (MD&A)	Auditors / Management
10	Business	Management / Lead Bankers
11	Management	Outside Counsel
12	Executive Compensation	Management/Outside Counsel
13	Principal and Selling Stockholders	Outside Counsel
14	Certain Relationships and Related Party Transactions	Outside Counsel
15	Description of Capital Stock	Outside Counsel
16	Shares Eligible for Future Sale	Outside Counsel
17	Material U.S. Federal Income Tax Considerations	Outside Counsel
18	Underwriting (Plan of Distribution)	Outside Counsel
19	Legal Matters	Outside Counsel
20	Experts	Outside Counsel
21	Where You Can Find Additional Information	Outside Counsel

Source: New Street Investor Relations

What’s in the “Business section” of an S-1?

The “Business section” of an S-1 refers to the comprehensive description of a biotech’s business and science – which ends up forming the mainstay of the prospectus’ summary.

It is highly advisable to go into an Org Meeting with a good first draft of a “business section” because so much of the rest of the S-1 follows from it (risk factors being just one example).

Typical contents include:

• Company overview and strategy

This is where you set the frame. Who are you? What unmet medical needs are you targeting? Are you a platform company, an asset-centric story, or something in between? Importantly, this section should articulate strategy, not just science. Investors want to understand how today’s pipeline decisions translate into long-term value creation.

• Pipeline and programs

For development stage biotechs, this is the heart of the Business section. Each material program is typically described in a consistent structure (usually from most important/advanced to least): indication, mechanism of action, development status, key data generated to date, and upcoming milestones. Claims must be precise, balanced, and supportable – especially when describing preclinical data or early clinical efficacy/signals.

• Scientific platform or technology (if applicable)

If your investment thesis hinges on a proprietary platform, this part of the section explains why it is differentiated and why it is repeatable. Investors will scrutinize whether the platform truly generates multiple shots on goal or simply supports a single lead asset with marketing flair.

• Manufacturing and supply

Often underestimated, this part of the section addresses how your product is made, who makes it, and where risk may sit. Reliance on third-party CMOs, scalability challenges, and single-source dependencies all tend to live here – and sophisticated investors will read it carefully.

• Intellectual property

This is not just a patent list. This part of the Business section typically summarizes patent families, expiration timelines, licenses, and any material encumbrances. It’s where investors begin forming views on durability and competitive moats.      

• Competition and market landscape

Would-be public biotechs are expected to acknowledge reality. That means naming competitors, alternative modalities, and standard-of-care options – even if imperfect. Overly sanitized competition sections are a red flag.

• Regulatory and commercialization considerations

This covers the development pathway, regulatory framework, and – where relevant – early commercialization thinking. For pre-revenue companies, it’s often more about preparedness than promises.

Who writes the Business section of your S-1?

Over the years I’ve witnessed the first drafts of S-1 business sections be written by a number of different parties:

• A Chief Commercial Officer (CCO).
• A Chief Science Officer (CSO) or Members of the Research team.
• A Vice President of Business Development.
• Junior members of a banking team.
• Cambridge, MA,- based CBT Advisors (led by the incomparable Steve Dickman).
• A CFO.
• An Investor Relations firm in partnership with a CEO, CFO or COO.

The “Business section” usually takes a village to write – drawing from numerous sources within a company – but with one or more writers working in solitude. By contrast, post-org meeting drafting sessions usually include all bankers, company counsel, underwriter’s counsel, the management team, and more.

Don’t forget to make time for due diligence.

One aspect of S-1 writing that generally gets overlooked is the due diligence that needs to be completed by third parties. Company’s and underwriter’s counsel will need to make sure that all of the claims being made in the S-1 are factual and not overstated. Constructing a data room during the creation of the initial S-1 draft can save a lot of time in this regard.