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Roman Kniazev, CEO of Nuravax, has emerged as one of biotech's most effective fundraisers, securing a mix of competitive grants and private investments to advance innovative drug programs. His latest success—a $3 million award from the National Institutes of Health (NIH)—will fund the Phase 1 clinical trial of Duvax, a first-in-class therapeutic vaccine targeting preclinical Alzheimer's disease. Kniazev shared some practical insights on navigating biotech's complex fundraising and clinical development landscape.

Navigating Biotech's "Valley of Death"

Launching a biotech startup means crossing the so-called "valley of death"—the gap between promising lab data and the clinical evidence required by venture investors.

"Pre-IND studies—when you're seeking FDA approval to begin human trials—are costly," said Kniazev. "Angel investors rarely fund this stage, so grants are essential."

To bridge the funding gap, Nuravax secured a mix of early-stage capital while assembling a cross-functional team of seasoned advisors in science, manufacturing, regulatory affairs, and clinical development.

"Winning isn't just about technology—it's about building a full ecosystem around it," Kniazev said. Investors recognize that a strong team has the expertise to bring innovation to market successfully.

For biotech founders, Kniazev offers five key insights from Nuravax's strategy:

1. Leverage FDA flexibility at Phase 1. The FDA allows biotech startups to use lean protocols and simplified manufacturing in the early stages—but don't mistake that for a free pass. Your product must still be well-characterized, and your documentation should anticipate future regulatory scrutiny.
2. Separate BDS and fill-finish to cut costs without cutting corners. Separating drug substance (BDS) production—the process of making the active ingredient—from fill-finish—the step where the drug is packaged into vials or syringes—can significantly reduce costs. Just ensure that both facilities follow Good Manufacturing Practices (GMP) and meet all FDA requirements.
3. Choose a CRO that speaks FDA. International or multi-country trials are fine, but if your goal is U.S. approval, your clinical research organization (CRO) must understand FDA regulations. Poor alignment here can delay your entire program.
4. Don't outsource critical thinking. Consultants can help, but they shouldn't drive your strategy. Founders must stay in control, ask the right questions, and understand what they're paying for. Often, it's cheaper—and smarter—to dive into the topic yourself. Even a basic understanding of the underlying regulations or technical requirements can help you choose the right service, negotiate more effectively, or, in some cases, handle the task internally.
5. Use non-dilutive funding strategically. Grants aren't just non-dilutive money—they are leverage. Grants give you time to build value before negotiating with investors on your terms.

How to Secure Grants and Government Funding

"Treat the application as if the project will move forward with or without the grant," said Kniazev. "NIH reviewers are looking for execution."

He recommends exploring not only NIH grants but also disease-specific nonprofits such as the Michael J. Fox Foundation for Parkinson's or the Alzheimer's Drug Discovery Foundation (ADDF).

"These organizations are led by experts with deep knowledge of current scientific and clinical trends," he said. "Their strategic, practical insights can strengthen your project—even if they don't invest."

A well-prepared Investigational New Drug (IND) dossier significantly improves your chances of both regulatory clearance and grant funding. This document serves as the FDA's first checkpoint before a drug can enter clinical trials and must include all data needed to justify its safety.

"Pre-IND meetings are valuable," Kniazev said, "Approach them strategically—every question you raise can turn into a formal requirement. Treat FDA recommendations as mandatory, and don't mention anything you're not fully prepared to execute."

The latest round of funding, secured by Kniazev through the NIH's highly competitive SBIR Fast-Track program, will support a Phase 1 clinical study of Duvax. The therapeutic vaccine targets amyloid-beta and tau—two key drivers of Alzheimer's—and is intended for use after pathology appears in the brain and bloodstream, before cognitive symptoms begin.

Strategies for Rapid Growth

Kniazev's strategy focuses on accelerating development timelines without sacrificing quality. "We've already shortened our path to registration by over 18 months," he says.

The team also plans to pursue Breakthrough Therapy and Accelerated Approval designations from the FDA. "If we see strong Phase 2 results, conditional approval could potentially come before Phase 3 is complete," Kniazev said. "Our goal is to get Duvax to patients as quickly as possible—lives depend on it."

As the drug moves into Phase 2 trials, the team is designing an ambitious clinical protocol using blood-based biomarkers and advanced brain scans (PET and MRI) to track biological and cognitive changes over time.

This multimodal approach aims to detect early therapeutic effects more efficiently, potentially eliminating the need for years—or even decades—of waiting to observe clinical deterioration.

"Relying solely on cognitive decline as an endpoint may delay progress for those with preclinical Alzheimer's," Kniazev said. "We aim to replace this model with real-time biological insights, working with diagnostic leaders in Europe and the U.S. to deliver a user-friendly solution—combining blood tests with a disease-modifying vaccine for early intervention."

Nuravax has signed a licensing agreement for another Alzheimer's vaccine candidate, separate from Duvax, covering the Australian market. The company is pursuing additional regional partnerships in Asia and the Middle East.

Build Around Real Market Demand

"Our model emphasizes in-house control over manufacturing, driven by proprietary formulation expertise," said Kniazev. Duvax is delivered in a freeze-dried format that allows long-term storage at –15°C to –25°C (5°F to –13°F)—far more practical than the ultra-cold –80°C (–112°F) required for many biologics.

"This is critical from a global perspective," Kniazev said. "In many lower-income countries, consistent access to ultra-cold storage is limited. For equitable access to Alzheimer's prevention, we must design products that align with the infrastructure available on the ground."

The formulation took more than 18 months, including optimization of reconstitution conditions to ensure consistent particle size, antigen stability, and immunogenicity.

"Combining two antigens in one vial isn't new," Kniazev said. "What sets Duvax apart is its stability, scalability, and clinical effectiveness."

Running Lean, Thinking Big: A Different Biotech Playbook

Kniazev has a dual background in economics and biotechnology—an uncommon combination he credits for shaping his execution-focused approach. "I left investing to build something with real social impact," he said.

While the U.S. biotech ecosystem provides top-tier infrastructure, regulatory expertise, and scientific talent, early-stage ventures without major institutional backing still face challenges raising capital—and when funding does come through, it's not always used efficiently.

"Many biotech startups spend only 40% of their budget on actual science," Kniazev noted. "The rest goes to overhead, consultants, and inflated operations."

Having operated in leaner, more resource-constrained environments, Kniazev believes financial discipline can be a strategic advantage. "When every dollar has to be justified, you build smarter. You stay focused on what really matters."

He also warns founders not to rely too much on advisors who focus only on avoiding risk instead of moving the project forward. "I've seen $2 million manufacturing plans balloon to $12 million because too many people added unnecessary steps and complexity," he said.

For Kniazev, success in biotech comes down to fundamentals. "There's no magic formula," he said. "Thoughtful planning, solid data, and a strong team drive value—that's how you reach the finish line."