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.

Often, a drug’s initial approval only hints at its full therapeutic potential and the eventual number of patients who may benefit over time. Continued R&D investment can unlock much more utility before the drug ultimately goes generic, but those investments require adequate incentives.

Our January 2023 analysis Semper Maior: Time to Reboot Biotech argued that the development-stage biotech industry had found its footing, following one of the sector’s most sustained and painful drawdowns. Now, in our first update to that analysis, we’re happy to report that development-stage biotech remains on solid ground. In the first half of 2023, biotech investors harvested considerable gains from M&A and have already partially redeployed that capital back into what is now a smaller, slightly more highly valued set of promising development-stage companies.

Clinical trials can fail, regulators change their minds, manufacturing might run into an unsolvable glitch, and venture capital might dry up. Given all the risks small biotech companies face that are outside of their immediate control, might it be safer to just work for a more stable, revenue-generating company? Maybe! But before you rule out jumping into a small biotech, consider the pros and cons.

It may surprise you to find out just how badly we’re failing to take a comprehensive approach to quantifying societal value from new innovations in medicine. The IRA’s investment in our climate future should be lauded; its treatment of medical innovation is unfortunately hobbled by its goal of lowering Medicare spending today at the expense of tomorrow’s patients – that is to say, all of us.

It’s long been assumed that as long as NICE-like cost-effectiveness analyses stay on the other side of the ocean, our US biotech ecosystem will be fine. But in recent years, toxic math has begun to make its way to US soil. Peter Kolchinsky sat down with Jayson Dallas to get his take on NICE’s tactics, their increasingly global reach, and how biopharma can fight back.

The treatment of NDA-path drugs in the Inflation Reduction Act materially degrades the investment case for these treatments in age-related diseases and thus jeopardizes future biotechnology progress and the health of America’s seniors.

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.

RA Capital’s TechAtlas team is currently accepting summer internship applications for 2023. Three of last year’s interns - Drew Biedermann, Ross Chikarmane, and Gabe Fox - are now permanent members of the TechAtlas team. Read their perspectives on their internship experience.

We asked ChatGPT some of the most common questions with which we see our elected representatives struggle. Does NIH invent drugs? What are profit margins like in the pharmaceutical industry? Will lowering drug list prices via imposing price controls on pharmaceutical companies lower patients' out-of-pocket costs? Find out what AI thinks.

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.

In today’s FutureCast discussion, RA Capital Principal Zach Scheiner, Senior Associate Becca Silberman, and Managing Partner Peter Kolchinsky talk about the past, present and future of depression therapies and why we’re confident that new uses and forms of old molecules, including psychedelics, will, in the next decade, bring relief to many of those among us who suffer from untreatable depression. Hop in the DeLorean with us at 88 miles per hour as we go 'Back to the Future'.