This is the first acquisition of a fully-baked, “home-grown” company from RA Capital’s RAVen incubator, which builds companies that our venture team funds and helps govern, so we wanted to mark the occasion by sharing a bit more about how we got here. 

There is a real and urgent need for better flu prophylaxis and therapeutics. RA Managing Director Laura Tadvalkar writes about why RA is excited to lead a transformative transaction that returns a long-acting antiviral for flu to its original developer Cidara, and RA’s new initiative to help make outlicensing from pharma companies faster and more efficient.

It’s fairly typical for companies to share confidential data with investors of their choosing before completing financing transactions, before publicly disclosing the data or the financing. How is this fair? Shouldn’t everyone get a chance to see the data so that no investor gets a better deal than anyone else? Peter Kolchinsky and Sarah Reed break down what’s allowed, what’s common, and what’s logical.

We wanted to expand RA Capital’s Gateway library of teaching modules to cover compensation-related topics, so we peppered experienced board member Steve Hoffman with questions about everything from managing stock option grants to tying bonuses to stretch goals. His answers did not disappoint.

A year ago we published the first “Semper Maior” piece, making the case that biotech was on firm ground and ready for a reboot. We put out the second piece last summer, when it felt like the rebound was underway. Had the year ended in October or even November… well, you know. But here we are after a general market and XBI surge feeling like biotech is now truly recovering from its prolonged downturn. So let’s mine the data, as we have before, to get a sense of what happened in 2023 and what lessons to take with us into 2024.

There’s a convention that public biotech companies should plan to raise money by the time they get down to one year of cash left on their balance sheets to avoid a dreaded “going concern” clause in their financial statements. But if you’ve got data on the way, it’s not always necessary to try to raise cash - particularly if the only terms you can get are draconian. Here’s a roadmap for deliberately navigating through that one-year threshold, owning the clause, and letting your data guide your financing strategy.

We asked three Gateway members who are or have been on Audit Committees – Kim Drapkin (CEO, Graphite Bio), Adam Mostafa (CFO, X4 Pharmaceuticals), and Sen Sundaram (CEO, Terns Pharmaceuticals) – to offer their best advice on Audit-related topics.

The technological renaissance in covalent inhibitor technology over the past decade is impressive. Relatively recent advances in structure-based drug design have unlocked the tantalizing opportunity to engineer covalency into small molecules. Now, RA Capital has incubated and seeded Hyku Biosciences to unlock histidines, tyrosines, and lysines for covalent modification to greatly expand the druggable proteome.

Silverback Therapeutics’s wind-down and reverse merger process can serve as a template for other companies when their clinical trials fail. The company’s response to its setback also teaches us about scenario planning, the importance of moving quickly when a key program doesn’t deliver hoped-for data, and why we should look ahead to a biotech ecosystem that anticipates the consequences of – and opportunities stemming from – its inevitable clinical setbacks.

On February 22, CMS announced that they would not be reconsidering the National Coverage Determination (NCD) that effectively denies Medicare patients access to lecanemab, a drug with accelerated approval for Alzheimer’s disease. CMS’s rationale was that “there is not yet evidence meeting the criteria for reconsideration.” It’s worth pausing to consider the highly unusual CMS precedent that is playing out in Alzheimer’s.

The federal government must address the failure of Silicon Valley Bank (SVB) with speed and clarity before it metastasizes into a national crisis, so the ecosystem of institutions in which SVB has operated, including other banks and investors, can help bridge companies so that they can continue to operate while they wait for their deposits.

The run-on-the-bank panic around SVB would have been quelled if everyone was dissuaded from succumbing to mass hysteria. Understanding what happened can help prevent further bank runs.

In today’s FutureCast discussion, RA’s Raj Shah, Jake Simson, Tess Cameron, and Peter Kolchinsky revisit one of our most talked-about articles: Time to Reboot Biotech. Fresh financial analysis and actionable board room advice abound.

We’ve suffered a protracted downturn in general interest in biotech. That downturn has been compounded by rising interest rates undercutting equities in general. Now we must determine 1) how much worse this downturn might be and 2) how we’ll do things differently once we reboot. Here, Peter Kolchinsky explains why he believes we’ve emerged from the downturn but must reboot biotech with more honest and efficient processes and better defend our industry’s value proposition to policymakers and the public.

Our year-end wrap of the site’s most popular articles of 2022 reflects a challenging year for the biotech sector, featuring tumultuous markets and the shifting drug pricing policy landscape. But those pieces also reflect the ingenuity, hopefulness, and opportunity that is inherent in drug discovery and development.

2020 and 2021 were the heyday for special purpose acquisition companies, or SPACs. We got in on the act ourselves – twice! – and we’ve learned a lot about why SPACs can sometimes work for a biotech in very particular circumstances, but also why mostly they don’t. We would also note that in certain market conditions, chasing merger targets with a SPAC can be extremely challenging. So we pulled the plug on our second SPAC. Here’s the story.

Thanks to the selfless efforts of a handful of smart and dedicated volunteers from a few tech transfer offices (TTOs), law firms, and investment firms, the fraught process by which technology licenses are extricated from universities is getting a significant upgrade.

Outgoing Forma Therapeutics CEO Frank Lee talks with Rapport about bringing a patient-centric mindset to a biotech steeped in science and Forma’s acquisition by Novo Nordisk.

The recent announcement by Alnylam Pharmaceuticals that it was holding off on a planned Phase 3 pivotal study for vutrisiran (marketed as Amvuttra in its sole approved indication so far, hATTR amyloidosis with polyneuropathy) in Stargardt disease illustrates how the Inflation Reduction Act is already having a negative impact on small molecule and orphan drug R&D prioritization. Alnylam’s announcement also brought out skeptics of the biotech industry, who argue the new law is being scapegoated by innovators who want to overturn its Medicare drug-negotiation provisions.

As the founder of two biotech companies in Arizona that are currently fundraising to support drug development, it’s clear to me that the Inflation Reduction Act will steer me away from developing cancer drugs for older Americans. This is a problem that can be fixed.