Frequently asked questions
Q1. What is non-dilutive funding and how is it different from venture capital?
Non-dilutive funding refers to capital you receive that does not require giving up equity in your company. Unlike venture capital or angel investment, you keep full ownership — there are no investors on your cap table, no board seats given away, and no pressure for a quick exit. Sources include federal grants (NIH, DOD, BARDA, NSF), federal contracts, private foundation grants, and state-level programs. For early-stage life science companies, non-dilutive funding can extend runway significantly, validate technology in the eyes of future investors, and fund R&D that would otherwise require dilutive financing. FreeMind helps life science companies make non-dilutive funding a core pillar of their financing strategy alongside equity capital.
Q2. What programs are US life science companies eligible for?
US based life science companies are eligible for the majority of granting sources including the NIH institutes (NCI, NHLBI, NINDS, NIAID, NIA, NEI, NIDDK, NIBIB, NIMH, etc.), DOW (US Army, DTRA, DARPA, CDMRP), BARDA, NSF, FDA, Private Foundations etc., with the exception of strictly academic programs such as center grants or program projects within the NIH. Small businesses that meet the SBIR/STTR eligibility criteria can submit to phased SBIR/STTR programs and win grants from $250,000 (Phase I) and upwards of $2,000,000 (Phase II).
Q3. Are non-US life science organizations eligible to apply to US-based non-dilutive sources of funding?
Yes — non-US organizations are eligible to apply for the majority of US-based grants. That said, non-US applicants are not eligible for the small business program (SBIR/STTR), which is reserved for US small businesses only. Many other NIH mechanisms (R01, R21, U01) and DOW and BARDA programs are open to international organizations. FreeMind has extensive experience helping non-US life science companies identify and apply for the mechanisms available to them.
Q4. How does FreeMind work with companies that are based outside the United States?
FreeMind has extensive experience working with non-US life science companies. While SBIR/STTR is restricted to US small businesses, many other federal funding mechanisms — including NIH R01s, R21s, U01s, DOD grants, and BARDA contracts — are open to international organizations. We work with clients in Australia, Europe, Canada, and beyond to identify the right mechanisms, structure the application for a non-US entity, and manage the submission process. If you are an international company with operations or a US subsidiary, we can also advise on whether structuring an SBIR-eligible entity makes strategic sense for your business.
Q5. Does my biotech company need to be profitable or revenue-generating to apply for grants?
No. Non-dilutive funding — and SBIR/STTR in particular — is specifically designed for early-stage companies that are pre-revenue or pre-commercial. You do not need existing revenue, profitability, or prior funding to apply. Many of FreeMind’s most successful clients have been pre-seed companies using SBIR as their first significant source of capital. What matters to reviewers is scientific merit, innovation, and a credible commercialization path — not your current financial position.
Q6. How do I register for the relevant government portals, and how long does it take?
To submit an application, an organization must be registered to the relevant government portals. Start with the System for Award Management (SAM.gov) — this assigns your company a Unique Entity Identifier (UEI) used across all federal submissions. Then register to Grants.gov and your target agency portal: eRA Commons for NIH, eBRAP for DoD, Research.gov for NSF. Non-US companies also need an NCAGE, which can take up to 10 days.
Registration can take anywhere from 2–6 weeks if everything goes smoothly — but it often doesn’t. Start early, allow 2–3 months of buffer, and follow up proactively with each portal.
Q7. How long does the funding review process take?
Depending on the agency — NIH, DOD, or BARDA — the review process typically takes 7–8 months from submission to award decision. At NIH specifically, your application is peer reviewed 3–4 months after submission, and the study section convenes 3–4 months after that. DOD and BARDA timelines vary by solicitation.
Q8. Can I use non-dilutive grant funds alongside venture capital or angel investment?
Yes — and this combination is increasingly common and encouraged. SBIR grants are non-dilutive and do not conflict with equity financing. Many investors actively encourage portfolio companies to pursue SBIR funding because it extends runway without dilution. There is no restriction on receiving venture capital while holding an SBIR award. The key rule: you cannot use SBIR funds for the same direct costs as another federal award covering the same scope of work (no double-dipping across federal programs).
Q9. What is the difference between SBIR and STTR — which one should I apply for?
Both are phased small business grant programs, but there is one key structural difference: STTR requires a formal research partnership with a US nonprofit research institution (typically a university or academic medical center), with at least 30% of the work conducted by that partner and at least 40% by the small business. SBIR has no such requirement — it is entirely company-led.
If your technology originated from academic research or you have a strong ongoing university collaboration, STTR can strengthen your application by leveraging institutional credibility. If you want full control, SBIR is typically the better path. As of the 2026 reauthorization, NIH now accepts Direct-to-Phase II STTR applications — a significant new option for companies with mature technology and established academic partners.
Q10. What stage does my company need to be at to apply for an SBIR grant?
There is no formal stage requirement for SBIR Phase I — it is designed precisely for early-stage companies with promising technology that needs proof-of-concept validation. You do not need clinical data, an IND, or revenue to apply. What you do need is a compelling scientific hypothesis, a clear public health or commercial need, and a credible team to execute the research. Pre-seed and seed-stage biotech and medtech companies apply successfully every cycle. Phase II applicants are typically expected to have completed a Phase I award, though Direct-to-Phase II pathways exist at NIH SBIR and STTR under the 2026 reauthorization.
Q11. Can a foreign-owned or foreign-founded biotech company apply for SBIR grants?
SBIR and STTR grants are reserved for US small businesses — meaning the company must be incorporated in the United States, at least 51% owned and controlled by US citizens or permanent residents, and have its primary place of business in the US. Foreign-born founders are fully eligible as long as they hold US citizenship or a green card and the company is a US entity. If your company is majority-owned by foreign nationals or a foreign corporation, it would not qualify. FreeMind can advise on whether establishing a US entity makes strategic sense for your situation.
Q12. What is a Direct-to-Phase II SBIR grant and am I eligible?
Direct-to-Phase II (D2P2) allows a small business to skip Phase I and apply directly for a Phase II award — typically $2M+ — without first completing a Phase I project. To qualify, your company must demonstrate that the feasibility and proof-of-concept work that Phase I would normally fund has already been completed using non-SBIR funds (e.g., VC, angel, academic research, or other grants). NIH has offered this pathway for SBIR for several years, and the 2026 reauthorization extended it to STTR as well. Not all NIH institutes accept D2P2 applications — eligibility depends on your target institute and topic area.
Q13. What is the new $30M SBIR Strategic Breakthrough Award and who qualifies?
The 2026 SBIR/STTR reauthorization created the Strategic Breakthrough Award, allowing agencies with extramural budgets over $100M to issue awards of up to $30 million to a single small business. To be eligible, your company must hold at least one prior Phase II SBIR or STTR award and demonstrate 100% matching funds from new private capital, new non-SBIR government funding, or a combination. The total period of performance is capped at 48 months. This is a transformational pathway for Phase II graduates ready to scale.
Q14. Can I apply to multiple agencies for SBIR funding at the same time?
Yes — a strategic multi-agency approach is often the right move. However, you cannot submit the same project to two agencies simultaneously; you can submit different research questions or aspects of your technology to different agencies. Starting in FY2027, each agency will cap submissions per company per fiscal year (NIH: 9 proposals; ARPA-H: 6). Planning your multi-agency strategy carefully — and early — is increasingly important. FreeMind specializes in building long-term, multi-agency grant strategies for life science companies.
Q15. What is the funding level for SBIR grants?
SBIR Phase I awards are typically in the $250,000–$300,000 range. Phase II awards are in the $2,000,000 range. Direct-to-Phase II and supplemental awards can be higher. Under the new 2026 Strategic Breakthrough Award, eligible companies can receive up to $30 million. DOD and BARDA programs may have different award ceilings, and clinical-stage programs at BARDA can reach tens or hundreds of millions for the right opportunity.
Q16. What makes a strong SBIR grant application — what do reviewers actually want to see?
Reviewers look for three things above all else: scientific merit, innovation, and commercial potential. A strong application tells a compelling story connecting a real unmet need to a novel scientific approach, with a credible team and a clear path to market.
The most common weaknesses in unsuccessful applications: vague specific aims, a commercialization section that feels like an afterthought, lack of preliminary data, and a team that does not demonstrate the right expertise. Reviewers are scientists — they will notice if your research approach is underpowered or your milestones are unrealistic. An experienced grant consultant significantly reduces these pitfalls.
Q17. Do I need preliminary data before submitting an SBIR Phase I application?
For Phase I, preliminary data is not strictly required — but it is highly advantageous. Applications with even modest preliminary data (from publications, prior research, or in-house experiments) consistently score better than those without. For Phase II and Direct-to-Phase II, strong preliminary data is essential — the expectation is that Phase I-equivalent feasibility work has already been completed.
Q18. Can I resubmit an SBIR application that was rejected?
Yes — and resubmissions are extremely common and often successful. At NIH, you are allowed one resubmission (A1) per application. The resubmission must include an introduction that responds directly to the reviewers’ critiques. Many companies score better on resubmission because reviewer feedback provides a precise roadmap for improvement. If a resubmission also fails, you can submit a new A0 application on a related but distinct project. FreeMind has extensive experience turning rejected applications into funded awards.
Q19. How long before the deadline should I start working on an SBIR application?
FreeMind highly recommends starting at least 6–8 weeks in advance of the deadline. You may need to identify collaborators or subcontractors, which takes time. Start by outlining the project at a high level — specific aims, milestones, scientific background, innovation, and main experiments. Then fill in the gaps. Third-party contributions often arrive at the last minute, so build in buffer. Start early!
Q20. What categories of expenses will SBIR programs typically fund — and what is excluded?
Allowable direct costs include materials, salaries (at a certain percentage of effort), animal costs, patient/hospital costs, and subcontractors such as CROs. On top of direct costs you can request 35–40% overhead (indirect costs), or 8% for non-US applicants. Costs that are typically not allowable include IP costs, the cost of preparing an IND, and most equipment purchases.
Q21. How do I find the right NIH institute or study section to submit to?
Choosing the right NIH institute and study section is one of the most strategically important decisions in the application process — and one of the most commonly underestimated. The NIH has 27 institutes and centers, each with its own scientific priorities, funded portfolio, and review culture. Submitting to the wrong institute can hurt your score even if your science is excellent.
Best approach: (1) search NIH Reporter (reporter.nih.gov) for recently funded projects similar to yours to see which institutes are active in your area; (2) review the institute’s current priority areas; (3) identify which study sections have reviewed similar work. FreeMind’s team has deep familiarity with NIH institute portfolios and can help you identify the optimal submission target.
Q22. What are the NIH review criteria?
NIH reviewers evaluate applications on five criteria:
- Significance to Public Health
2. Innovation
3. Investigators (Leadership)
4. Environment
5. Research Approach
Each reviewer scores each criterion from 1 (outstanding) to 9 (poor) and provides written strengths and weaknesses. Scores are aggregated and applications ranked against each other. The bottom 50% are marked “not discussed” and will not be funded. The top 50% receive a priority score between 10 and 90, where scores below 30 are typically fundable.
Q23. How does the NIH scoring system work?
Each reviewer scores each criterion from 1 (outstanding) to 9 (poor). Scores are aggregated into an overall impact score and applications are ranked. The bottom 50% are marked “not discussed” (ND) and receive no further review. The top 50% receive a priority score between 10 and 90 — scores below 30 are typically in the fundable range, with exceptions in either direction depending on the institute’s payline that year.
Q24. What is a “not discussed” outcome at NIH and what should I do next?
A “not discussed” (ND) outcome means your application fell in the lower 50% of scores at the study section and was not debated by the full panel. It does not mean your science is bad — it often means the application did not score competitively enough relative to others in that cycle, or that specific weaknesses caused reviewers to rank it lower. You will still receive written critiques from assigned reviewers, and these are extremely valuable.
An ND is not a rejection — it is a roadmap. Treat the feedback as the foundation for a stronger resubmission. Review the critiques carefully, address every weakness systematically, and consider whether the study section or institute assignment was optimal. FreeMind regularly helps clients turn ND outcomes into funded resubmissions.
Q25. Is the NIH review process confidential — will my application be made public?
NIH provides strong tools to protect applicants’ proprietary information. You can mark specific lines as proprietary. All assigned reviewers must sign a CDA, and the review panel is made public prior to review so you can flag any conflicts of interest. The application itself is confidential (only the abstract becomes public after an award), and it does not constitute a public disclosure for patent purposes — it is not accessible to persons skilled in the art.
Q26. Do I have any obligations to the US government once I receive an NIH award?
Aside from march-in rights and reporting/sharing of research findings, you are not obligated to provide anything in return. As a grant (not a contract), no money is returned upon completion, no matching funds are required, and no royalty payments are due.
Q27. What DOD programs are available to life science companies?
The Department of Defense funds life science research through several programs relevant to biotech and medtech companies:
CDMRP (Congressionally Directed Medical Research Programs) — funds high-impact, high-risk research across oncology, rare diseases, traumatic brain injury, and more. CDMRP is known for funding programs that other agencies won’t.
USAMRDC (US Army Medical Research and Development Command) — funds medical materiel research with a military health focus, including infectious disease, trauma, and regenerative medicine.
DARPA — funds transformative, high-risk/high-reward research. Highly competitive and typically requires a direct relationship with a program manager.
DTRA (Defense Threat Reduction Agency) — focuses on WMD threats, including biodefense.
DOD SBIR/STTR — the DOD runs its own SBIR program across multiple components including the Army, Navy, Air Force, and DHA.
FreeMind has deep experience identifying which DOD programs align with a given life science pipeline and writing competitive applications for each.
Q28. Does my technology need a direct military application to qualify for DOD funding?
Not necessarily. While some DOD programs are strictly defense-focused, many — particularly CDMRP — fund research with broad clinical impact where the connection to military health is meaningful but not exclusive. CDMRP programs cover cancer, Alzheimer’s, rare pediatric diseases, and many other conditions that affect both service members and the civilian population. If your technology has any relevance to the health of military personnel, veterans, or their families, DOD funding may be a viable path. FreeMind can help you assess fit and frame your application for a DOD audience.
Q29. How does the DOD SBIR program differ from the NIH SBIR program?
Both are SBIR programs with the same Phase I/Phase II structure and similar award ceilings, but there are meaningful differences in process, culture, and priorities. DOD SBIR topics are published in solicitation batches (typically 3 per year) and are much more prescriptive — you are responding to a specific technical topic defined by the agency. NIH SBIR allows more flexibility in defining your own research question within broad program areas. DOD reviewers tend to focus heavily on transition potential (Phase III commercialization), while NIH reviewers weight scientific rigor and significance. Relationships with DOD program managers and topic authors can also meaningfully influence outcomes in ways that are less common at NIH.
Q30. What does BARDA fund and is my company eligible?
BARDA (Biomedical Advanced Research and Development Authority) funds the advanced development of medical countermeasures — vaccines, therapeutics, diagnostics, and devices — targeting chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases. BARDA is particularly relevant if your technology addresses a public health emergency preparedness need.
Unlike NIH, BARDA primarily funds companies at a more advanced stage of development — typically with existing proof-of-concept data and an identified regulatory pathway. Award sizes are significantly larger than NIH SBIR, often in the tens to hundreds of millions for late-stage programs. Both US and non-US companies may be eligible depending on program structure.
Q31. How do I apply for BARDA funding — is there an open solicitation?
BARDA funding is primarily obtained through two routes: (1) responding to a Broad Agency Announcement (BAA) or other public solicitation, and (2) directly engaging with BARDA’s DRIVe (Division of Research, Innovation, and Ventures) innovation ecosystem or BARDA Ventures for earlier-stage opportunities. Unlike NIH, BARDA does not have fixed submission deadlines — BAAs are often open for extended periods and require white paper submissions before a full proposal invitation. Building a relationship with a BARDA project officer before submitting significantly improves your chances. FreeMind has experience navigating BARDA’s unique procurement process.
Q32. What is the difference between a BARDA contract and a grant?
Most BARDA support comes in the form of contracts — not grants. This is an important distinction. A contract is a procurement vehicle where the government is purchasing specific research or development outcomes. This means you have more defined deliverables, more government oversight, and potentially more reporting requirements than a typical NIH grant. However, BARDA contracts can be far larger than grants — multi-year awards worth tens or hundreds of millions are common for promising medical countermeasure candidates. If your program is at the right stage and addresses a BARDA priority area, a contract can be transformational.
Q33. What types of life science companies should consider NSF SBIR funding?
NSF SBIR is best suited for companies developing deep technology with broad commercial potential across any sector — including life sciences, medtech, diagnostics, digital health, and biotools. Unlike NIH, NSF does not require your technology to address a specific disease or clinical need. If your platform has multiple applications, or if your innovation is more technology-driven than disease-focused (e.g., a novel manufacturing process, a diagnostic platform, a software-enabled medical device), NSF SBIR may be a strong fit alongside or instead of NIH. NSF also has a strong track record of funding enabling technologies that underpin life science R&D.
Q34. How is NSF SBIR different from NIH SBIR?
The key differences are focus, process, and culture. NIH SBIR is disease-focused and scientifically rigorous — reviewers are biomedical scientists evaluating your research approach and significance to human health. NSF SBIR is innovation- and commercialization-focused — reviewers evaluate the novelty of your technology and the size of the commercial opportunity. NSF requires an invitation to submit a full proposal (based on a preliminary Project Pitch), whereas NIH accepts applications on defined submission cycles. NSF also places a stronger emphasis on the broader societal and commercial impact, and is generally more receptive to platform technologies and non-clinical innovations.
Q35. What is the NSF Project Pitch and do I need one before applying?
Yes — for NSF SBIR Phase I, you must submit a Project Pitch before being invited to submit a full proposal. The Project Pitch is a short (1–2 page) overview of your technology, the commercial opportunity, and your team. NSF program officers review pitches on a rolling basis and either invite a full proposal or decline. If invited, you have 60 days to submit your full Phase I application. This is different from NIH, which accepts full applications without a pre-screening step. The Project Pitch is an opportunity to get early feedback from NSF on program fit before investing in a full write.
Q36. Does an award recipient retain the title to inventions conceived using NIH grants?
Yes — as long as award recipients comply with the Bayh-Dole Act, they retain title to any invention conceived or first reduced to practice using HHS grant funds. This was a landmark provision when enacted in 1980 and remains the foundation of US research commercialization policy. Recipients must report inventions, make efforts to commercialize through patent or licensing, acknowledge federal support in all patents, and grant the federal government a limited use license.
Q37. Will applying for a government grant expose my proprietary technology or undermine a future patent?
No — if managed correctly. SBIR and NIH grant applications are confidential documents. They are not published and do not constitute a public disclosure under US patent law, meaning they cannot be used as prior art against your future patent filings. Only the abstract becomes public after an award is made. Within the application, you can mark specific lines as proprietary, and all reviewers are bound by NDAs. That said, always consult with IP counsel before including highly sensitive unpublished data. FreeMind’s team is experienced in helping clients frame their science compellingly without overexposing proprietary details.
Q38. What is the Bayh-Dole Act?
Enacted in 1980, the Bayh-Dole Act grants first rights to a patent for an invention fully or partially funded by a federal agency to the awardee organization — not the government. The Act encourages researchers to patent and commercialize federally funded inventions by guaranteeing patent rights to recipients, provided they comply with reporting and commercialization obligations. More information: grants.nih.gov/grants/bayh-dole.htm
Q39. What are March-in Rights?
March-in rights give the federal government the right to grant licenses to other entities — or license the technology itself — if the patent holder aided by federal funding fails to commercialize the invention effectively or address a public health need. This right is strictly limited and can only be exercised if specific criteria are met. In practice, no federal agency has ever exercised its march-in rights to date — it remains a theoretical safeguard. More information: 35 U.S. Code § 203
Q40. What does FreeMind actually do — are you grant writers or grant consultants?
FreeMind is a full-service non-dilutive funding consultancy — not simply a grant writing service. The distinction matters. Grant writers produce documents. FreeMind builds funding strategies. We start by assessing your pipeline, stage of development, and commercial goals to identify the right funding sources, mechanisms, and timing. We then manage the entire application process — from identifying the right solicitation and crafting the narrative, to coordinating with your scientific team, managing government portals, and responding to reviewer feedback on resubmissions. We have been doing this since 1999 and help our clients win over $100M per year from NIH, DOD, BARDA, NSF, and other agencies.
Q41. How much does it cost to work with a grant consultant, and is it worth it?
Grant consulting is an investment — and the return is measured in the size and likelihood of the awards you win. FreeMind engagements are structured based on scope of work, number of submissions, and program complexity. We do not charge on a contingency basis (a percentage of the award), as this is prohibited for federal grants. What we can tell you: companies working with experienced consultants consistently achieve higher success rates than those applying independently — and a single Phase II award of $2M+ more than justifies the consulting fee many times over. Contact us for a specific proposal based on your needs.