ReCode breaks the mold with $120M financing, bringing clutch of Big Pharmas along for ride

ReCode Therapeutics has stuck to a formula of $80 million funding rounds, but, thanks to investments from the venture arms of Bayer and Amgen, the genetic medicine and mRNA biotech is breaking the mold with a $120 million extended series B.

The initial $80 million series B financing round was announced last October and co-led by Pfizer Ventures—an active investor in biotechs and emerging science the Big Pharma deems promising—with recent contributions fueling Dren Bio and ImCheck Therapeutics, among others. The other leader was EcoR1 Capital, a San Francisco biotech investment firm that boasts 65 portfolio companies. Other initial series B investors included Sanofi Ventures, Orbimed, Vida Ventures and more.

Now, the extended round—co-led by new investors AyurMaya, an affiliate of Matrix Capital Management, and Leaps by Bayer, with participation from Amgen Ventures—has raked in an extra $120 million, boosting the series B total to $200 million.  

Recode, Shehnaaz Suliman
Shehnaaz Suliman, M.D. (ReCode Therapeutics)

The oversubscribed fund is a great leap from the genetic medicine company’s series A round—which closed in March 2020 at $80 million.  

The proceeds from the earlier series B funding will push the biotech’s two lead mRNA programs towards human studies, ReCode CEO Shehnaaz Suliman, M.D., told Fierce Biotech. The leader stepped into the CEO role this January after holding the president and chief operating officer posts at Alector. She took the reins from David Lockhart, Ph.D., who moved over to be chief scientific officer and remained in his role as president.

ReCode’s lead programs target cystic fibrosis (CF) and primary ciliary dyskinesia (PCD), a lung disease similar to CF. A group of genetic mutations leave PCD patients without the proteins that make cilia—the fingerlike projections in the airways—or defective versions of it. Because the cilia don’t work properly, PCD patients can’t clear mucus normally, and subsequently suffer respiratory infections that can eventually lead to lung function loss.

The California biotech’s genetic medicines are to be administered via its lipid nanoparticle technology (LNP) delivery platform. The platform is engineered to deliver genetic therapies directly to the organs and cells most impacted by disease, which, if successful, could be the first LNP technology to do so. It was previously thought that LNPs could only be delivered to the liver, Suliman explained. 

ReCode’s Selective Organ Targeting (SORT) LNP platform offers several modes of administration and supports a range of genetic cargo, including mRNA, siRNA, DNA, gene correction components and mixed cargoes.

ReCode anticipates filing a request with the FDA to move the PCD program into human testing in the fourth quarter of this year, Lockhart told Fierce Biotech, while the CF program should follow in mid-2023.

The goal had been to have these lead programs in the clinic by late 2021, but the pandemic pushed that timeline back, Lockhart said. In particular, the limited availability of primates and availability of slots at specialized CROs that perform inhalation studies in primates slowed the process.

ReCode president, chief scientific officer, ReCode Therapeutics
David Lockhart, M.D. (ReCode Therapeutics)

Though a bit behind schedule, the delay didn’t seem to impact the collection of some key results. In May, ReCode presented preclinical data from the PCD and CF programs at the American Thoracic Society 2022 International Conference in San Francisco, demonstrating that the SORT LNP-formulated candidates can be delivered directly to disease-relevant cells without significant exposure to other tissue. 

The data may have pulled more investors in after the initial October series B. The money from the extension round will bankroll platform expansion and diversification efforts, as the biotech aims to grow its pipeline into central nervous system diseases along with lung, liver, and oncology indications. 

When asked about specific disease targets within those indications, Lockhart said ReCode is following the science, adding that the next wave of therapeutics will include gene correction in stem cell populations for CF, as well as gene correction for other genetic respiratory and liver diseases.

The SORT LNPs can also be tuned to deliver to cells of the spleen, including T and B cells, which opens the door to the possibility of in vivo CAR-T therapies, according to Lockhart.

ReCode intends to grow alongside the pipeline expansion, according to Suliman, who anticipates the team, which currently sits around 70 people, to reach 100 members in the next six to 12 months.

In tandem with ReCode’s financing round, Alan Colowick, M.D., managing director of Matrix, and Rakhshita Dhar, senior director of Venture Investments Health at Leaps by Bayer, have joined the biotech’s board of directors.