Biotech IPOs are still coming in all sorts of flavors these days.
Just look at what’s on the menu from Friday: There’s Finch Therapeutics, which needs the money to complete a second pivotal trial and start plotting commercialization of its microbiome-based products; Connect Biopharma, a Chinese outfit going through mid-stage studies in T cell-driven inflammatory diseases; Instil Bio, whose team is trying to ride a compassionate use program with their autologous tumor infiltrating lymphocytes straight into Phase II; Transcode Therapeutics, an under-the-radar cancer therapy developer leveraging multiple RNA modalities; and then there’s a SPAC — Foresite Capital’s third.
With the exception of Transcode, all the public company wannabes penciled in $100 million in their initial filings, a number that’s increasingly unreliable as a placeholder. Foresite, meanwhile, is looking to raise $250 million for its blank check company.
To keep up to date with the travails of all biotechs going public, check out the Endpoints News IPO Tracker.
Now 2-in-1, Finch Therapeutics looks to turn the corner on microbiome therapies
When Mark Smith helped start the nonprofit stool bank OpenBiome in 2012, there weren’t reliable, standardized ways to manufacture and distribute stool preparations for fecal microbiota transplants. More than eight years later, he believes new alternatives are on the horizon.
Finch Therapeutics’ S-1 dropped just days after OpenBiome announced it’s phasing out production of new treatments, with an aim to save enough inventory to meet demand throughout 2021 “as a bridge to FDA-approved therapies.”
The biotech wants to bring one of those therapies to the market. CP101, a capsule made of freeze-dried stool samples from healthy donors, has hit the mark on recurrence-free bacteria clearance for patients with a C. difficile infection — results that Smith, co-founder and CEO at Finch, said came at a turning point for the field. After some early failures and implosions, scientists may have found the right way to pack all the benefits of a fecal microbiota transplant (FMT) into a pill and skip the cumbersome procedure.
A second, confirmatory trial is expected to begin not long after Finch lands on Nasdaq and should read out in 2023.
The biotech is also planning other clinical studies in chronic hepatitis B, irritable bowel disease and autism spectrum disorder — the latter involving different pills with select strains of microbes instead of all of them.
They will be doing it with some assets purchased from OpenBiome, including the biological samples accrued over the years and technology so that they can “internalize some of functions for which we have previously relied on OpenBiome,” according to a filing. The whole deal will cost around $5 million.
Connect Biopharma wants to take on Dupixent
Founded by two old pals whose friendship traces back to a university in Guangzhou, China, Connect Biopharma had snagged $115 million from a slate of marquee investors back in August.
RA Capital Management led the Series C while Lilly Asia Ventures, Boxer Capital and HBM Healthcare Investments, Qiming and Advantech chimed in.
The main draw? A pipeline of immune modulators, led by an anti-IL-4Ra antibody, that can treat inflammatory allergic diseases such as atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps. These are big indications chased by some of the top names in the global biopharma world — in fact, the lead drug hits the same target as Regeneron and Sanofi’s Dupixent — but Connect believes the assays they used in drug discovery could make them a best-in-class contender.
The big reveal will come in the second half of 2021, when topline Phase IIb results are due.
Instil Bio seeks a spot among emerging TIL players
By diving into tumor-infiltrating lymphocytes, Instil Bio faces some high-profile competition not just with TIL players like Iovance, Adaptimmune and PACT Pharma but also CAR-T and TCR-T cell therapy developers like Gilead’s Kite and Bristol Myers Squibb’s Juno.
Yet the Dallas-based biotech is all-in on the tech platform — including the manufacturing know-how — it first in-licensed then acquired from Immetacyte, a University of Manchester spinout that’s been running a compassionate use program at a UK hospital for eight years.
Since its founding in 2018, it’s raised $380 million of venture funding to get here.
The plan now is to submit an IND to the FDA — its first — and jump straight into a Phase II trial for melanoma later this year, which Instil hopes can support a BLA submission as early as 2023.
Given how frequently CMC issues trip up cell and gene therapies these days, though, there’s likely a long way to go for its in-house manufacturing crew.
An under-the-radar RNA player offers some delivery solutions
Founded and led by CRO vet Michael Dudley, Boston-based Transcode Therapeutics is focused on delivering RNA drugs to where they are needed to kill cancer.
And they are ambitious.
The lead candidate is designed to treat metastatic cancer, meaning tumors in the breast, pancreas, ovary, colon or even the brain.
“To date, research into RNA efficacy has been limited due to three delivery-related challenges: protecting the RNA from being dismantled by the immune system; maintaining stability so the molecule has time to do its job; and penetrating the targeted organs and cells,” the S-1 read. “Our strategy seeks to overcome these delivery challenges by repurposing a particle used extensively in humans for imaging purposes to deliver synthetic RNA molecules (called oligonucleotides) to cancer cells.”
Foresite wants one more blank check at its disposal
Having completed the merger for its first SPAC and raised $175 million for a second, Foresite has made it clear that it views SPACs as an extension of its venture investing business.
“Having that as an option for an entrepreneur that is within the Foresite family, we think it’s a nice option,” managing director Michael Rome told Endpoints News recently. “So really we view the SPAC as sort of a — something we can offer a company.”
On the hunt for companies deploying tech to solve biotech problems, they can get quite specific with the kind of targets to merge with, as the $216 deal with Gemini Therapeutics showed.