From The Editor | December 22, 2025

Biology, Specificity, and the Rules of RNA Business Strategy In 2026

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By Anna Rose Welch, Editorial & Community Director, Advancing RNA

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In preparation for writing this installment of my 2026 outlook series, I found myself looking back into the past — specifically December 2023 — when I published my 2024 outlook article, “Defining a Competitive, Next-Gen RNA Therapeutic.” Obviously, this was an exercise in seeing how our perceptions of the industry have since changed. Interestingly, they haven’t changed all that much. Back in 2023, there was, as there still is today, talk about next-gen mechanisms of action (namely saRNA and circRNA), as well as an ongoing need for clinical data in therapeutic indications to demonstrate that mRNA is not a “one trick pony.”

As the industry advances, however, our conversations, goals, and desires become increasingly clarified, and our conversations around how to accomplish these goals become more nuanced. It was this increasing sophistication that I noted as my conversations with C-suite executives for my 2026 outlook gravitated toward what can make an mRNA/RNA company stand out from the crowd in the upcoming year.

As parts 1 and 2 of this conversation emphasized, our products are increasingly entering the clinic, and we anticipate that 2026 will be the year we finally learn what our different RNA modalities can do as in vivo gene therapies, in vivo CAR-Ts, personalized immunotherapies, and epigenetic editing therapies.

However, we also know that our RNA products remain works in progress — both biologically and as business assets. Here, in part 3 of this outlook series, we continue our forward-looking conversation with Signify Bio CBO, Renee Williams, who shares why she hopes 2026 is the year we “focus in” on three important factors — namely our biology, our platforms, and our IP — and what this looks like/means strategically. 

The "Biology-First" Movement: Turning Funding Pressures into Strategic Partnerships

Last year, in my Top 5 mRNA developments of 2024 article, I called out the number of academic RNA centers arising to “help our science catch up.” And then, as we all know, 2025 happened, and government funding for academic research — particularly RNA-oriented research — became much harder to come by.

Though less funding is far from ideal, I was struck by how several of my year-end conversations with executives looked at this not as a limitation but as an opportunity for industry and academia to tighten their relationship. On the one hand, the funding pressures of today could translate into fewer academic investigators spinning out technologies into their own companies. As such, biotechs become the doorway to the clinic for aspiring academic products.  

But as we also know, academia is typically where we get answers to the biological questions biotechs don’t have the time or resources to answer. And as Williams emphasized, having a deep understanding of the biological underpinnings of our products has become increasingly paramount for biotechs.  

“Investments today are going to products where the biology is well understood and/or to targets that are well validated,” she explained. “It’s not enough anymore to showcase what a technology can do without being able to explain why it performs the way that it does. This is why I think, over the next three years, we’re going to see a ‘biology-first’ movement, where understanding the biology of our products becomes an even more important part of our business strategies.”

As she went on to explain, one of the ways companies can deepen their understanding of their products’ biology and/or their indications is by establishing a sponsored research agreement (SRA) with an academic partner. Such partnerships can be a great way for smaller, resource-constrained companies to answer the foundational biological and mechanistic questions that may arise when talking to investors. In fact, as she went on to explain, this has been an important part of Signify Bio’s strategy; the company has established an SRA with multiple groups at a single university boasting expertise in the renal and cardiac indications.

“A company can have an excellent C-Suite that deeply understands the nuances of mRNA translation and delivery, but that doesn’t mean they’re experts in the underlying biology of multiple indications across various tissues,” she added.

Setting up an SRA offers several benefits to both parties. For one, such an arrangement offers academia a chance to garner additional funding during this financially trying time. For the biotech, in some instances an SRA can be established for the minimal cost of one full time employee, whether it be a graduate student or a post-doc. In turn, the company garners access to the university’s technology and expertise, both of which serve as critical resources to delve into and answer foundational biological questions.

Proprietary Power: How Focused Platforms Drive 2026 Deals

Not only do companies need to focus more deeply on biology in the new year, but they need to be equally attentive to how they’re structuring their platforms. Having been in investor-related and business development roles in the past, Williams has been privy to the biggest missteps that can significantly stymie biotech acquisitions and funding for a platform.

On the IP front, for one, it’s critical for a company — especially a spinoff — to be able to clearly delineate who owns and has access to their technology.

Likewise, the same level of specificity and narrative simplicity is essential when establishing a platform. Though she acknowledged it may not be a popular opinion, she argued that the hub-and-spoke model is not a sound strategy for a company looking to garner funding today. Rather than spend resources showing minimal data for a technology in “everything,” she argued strongly in favor of seeing more data — namely NHP data and Phase 1 data — in fewer applications.

“Show me how your technology works in two indications, and, even more importantly, demonstrate how those two indications are related,” she clarified. “How does working in one indication help validate the technology in the second indication? The death of a platform is trying to prove the technology can work in everything rather than using your resources to garner data that inspires conviction.”

Missed parts 1 and 2 of this 2026 Outlook series? Never fear — catch up here: